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WO2025160254A1 - Système de pose de prothèse valvulaire cardiaque - Google Patents

Système de pose de prothèse valvulaire cardiaque

Info

Publication number
WO2025160254A1
WO2025160254A1 PCT/US2025/012715 US2025012715W WO2025160254A1 WO 2025160254 A1 WO2025160254 A1 WO 2025160254A1 US 2025012715 W US2025012715 W US 2025012715W WO 2025160254 A1 WO2025160254 A1 WO 2025160254A1
Authority
WO
WIPO (PCT)
Prior art keywords
valve positioning
valve
struts
distal
balloon
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/US2025/012715
Other languages
English (en)
Inventor
Hannah Marie Glas
Camille Lazaro VILLADOLID
Katherine Elizabeth MESSER
Sean Chow
Izaak ROSEN
Ulrich Pfeiffer
Eric Robert Dixon
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Edwards Lifesciences Corp
Original Assignee
Edwards Lifesciences Corp
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Edwards Lifesciences Corp filed Critical Edwards Lifesciences Corp
Publication of WO2025160254A1 publication Critical patent/WO2025160254A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2427—Devices for manipulating or deploying heart valves during implantation
    • A61F2/243—Deployment by mechanical expansion
    • A61F2/2433—Deployment by mechanical expansion using balloon catheter
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/958—Inflatable balloons for placing stents or stent-grafts
    • A61F2002/9583—Means for holding the stent on the balloon, e.g. using protrusions, adhesives or an outer sleeve
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2220/0075—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0039—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in diameter

Definitions

  • the present disclosure relates to delivery systems for prosthetic heart valves, and in particular to delivery systems with inflatable balloons for deploying prosthetic heart valves.
  • the human heart can suffer from various valvular diseases. These valvular diseases can result in significant malfunctioning of the heart and ultimately require repair of the native valve or replacement of the native valve with an artificial valve.
  • repair devices for example, stents
  • artificial valves as well as a number of known methods of implanting these devices and valves in humans.
  • Percutaneous and minimally-invasive surgical approaches are used in various procedures to deliver prosthetic medical devices to locations inside the body that are not readily accessible by surgery or where access without surgery is desirable.
  • a prosthetic heart valve can be mounted in a crimped state on the distal end portion of a delivery apparatus and advanced through the patient’ s vasculature (for example, through a femoral artery and the aorta) until the prosthetic heart valve reaches the implantation site in the heart.
  • the prosthetic heart valve is then expanded to its functional size, for example, by inflating a balloon on which the prosthetic valve is mounted, actuating a mechanical actuator that applies an expansion force to the prosthetic heart valve, or by deploying the prosthetic heart valve from a sheath of the delivery apparatus so that the prosthetic heart valve can selfexpand to its functional size.
  • prosthetic heart valves Described herein are prosthetic heart valves, delivery apparatuses, delivery systems, and methods for implanting prosthetic heart valves.
  • the disclosed prosthetic heart valves, delivery apparatuses, delivery systems, and methods can, for example, provide for improved positioning of a prosthetic heart valve on a delivery apparatus, for example, during advancement of the delivery apparatus through a patient’s vasculature, among other things.
  • the devices and methods disclosed herein can, among other things, provide improved balloon expandable delivery systems.
  • a delivery system for a prosthetic implant can comprise a handle and one or more shafts coupled to the handle.
  • This basic configuration can desirably be provided with any one or more of the features described elsewhere herein, in particular with those of the examples described hereafter.
  • the basic configuration can desirably also be provided with any one or more of the features shown in the figures and/or described in conjunction with the figures, either in addition to or alternatively to the features of the examples described hereafter.
  • the delivery system can additionally or alternatively comprise a balloon coupled to a distal end portion of the one or more shafts.
  • the balloon can be configured to be inflated at least from a first, deflated state to a second, radially expanded, inflated state.
  • the delivery system can include a first valve positioning structure, either as an alternative to the balloon or in addition to the balloon.
  • the first valve positioning structure can extend at least partially over an exterior surface of the balloon, which can have a first end portion and a second end portion.
  • the first valve positioning structure can be configured to radially expand at least from a radially collapsed state to a radially expanded state when the balloon is inflated.
  • the first valve positioning structure can resiliently radially collapse from the radially expanded state to the radially at least partially collapsed state when the balloon is deflated.
  • the first valve positioning structure can comprise a frame constructed of a shape-memory material.
  • the frame can be shape set in the radially collapsed configuration, or at the second end portion.
  • the first valve positioning structure can extend around the exterior surface of the balloon at the first end portion.
  • the first valve positioning structure can extend around the exterior surface of the balloon at both the first end portion and the second end portion of the balloon. [0016] In some examples, the first valve positioning structure can comprise at least a proximal valve positioning portion and/or a distal valve positioning portion.
  • the first valve positioning structure can include an intermediate valve positioning portion disposed between the proximal and distal valve positioning portions.
  • the proximal valve positioning portion can be coupled to the shaft.
  • the delivery system can further comprise a nose cone distally disposed relative to the balloon.
  • the distal valve positioning portion can be coupled to the nose cone.
  • the intermediate valve positioning portion can be configured to receive the prosthetic valve.
  • the distal valve positioning portion can have an outer diameter that is equal to or greater than an outer diameter of the intermediate valve positioning portion.
  • the proximal valve positioning portion can have an outer diameter that is equal to or greater than an outer diameter of the intermediate valve positioning portion.
  • the distal valve positioning portion can comprise a plurality of struts.
  • the plurality of struts can include a first plurality of struts arranged in a first row that extends in a circumferential direction of the delivery system. [0026] In some examples, the plurality of struts can include a second plurality of struts arranged in a second row that extends in the circumferential direction.
  • each one of the first plurality of struts can be a linear stmt oriented at an angle relative to an axial direction of the delivery system.
  • at least a portion of each one of the first plurality of struts can be a linear strut oriented in an axial direction of the delivery system, desirably oriented parallel to the axial direction of the delivery system.
  • each one of the second plurality of struts can be a serpentine strut.
  • each one of the second plurality of struts can be a zigzag strut.
  • the balloon can have an axial length in a range from 45 mm to 51 mm.
  • the balloon can have an axial length in a range from 31 mm to 45 mm.
  • the balloon can have an axial length in a range from 25 mm to 31 mm.
  • the frame can comprise a braided mesh structure.
  • the first valve positioning structure can comprise a polymeric coating attached to the frame.
  • the delivery system can further comprise a second valve positioning structure extending over the exterior surface of the balloon.
  • first valve positioning structure and the second valve positioning structure can be spaced apart in an axial direction of the delivery system. [0038] In some examples, the first valve positioning structure and the second valve positioning structure can define a valve mounting portion of the delivery system configured to receive the prosthetic valve.
  • neither the first valve positioning structure nor the second valve positioning structure extend over an outer surface of the prosthetic valve when the prosthetic valve is mounted over the valve mounting portion.
  • the delivery system can further comprise at least one tether connected to the first valve positioning structure.
  • the at least one tether can be configured to cause the first valve positioning structure to further radially collapse when the first valve positioning structure is in the radially collapsed state and tension is increased in the tether.
  • the at least one tether can comprise a first end portion and a second end portion, wherein the first end portion of the at least one tether is coupled to the first valve positioning structure, and wherein the second end portion of the at least one tether is coupled to the second valve positioning structure.
  • the first valve positioning structure can extend at least substantially an entire length of the balloon.
  • the first valve positioning structure is configured such that it does not overlap or extend over any portion of an outer surface of an implant (for example, a prosthetic heart valve) mounted in a radially compressed state on a balloon of the delivery system.
  • an implant for example, a prosthetic heart valve
  • the first valve positioning structure is configured such that it does not overlap or extend over any portion of an outer surface of an implant (for example, a prosthetic heart valve) mounted in a radially compressed on the first valve positioning structure.
  • an implant for example, a prosthetic heart valve
  • the first valve positioning structure is configured such that when an implant (for example, a prosthetic heart valve) is mounted in a radially compressed state on the first valve positioning structure, no portion of the implant contacts the balloon of the delivery system.
  • an implant for example, a prosthetic heart valve
  • a delivery apparatus comprises: a handle, a shaft, a balloon, and a valve positioning structure.
  • the shaft can optionally be coupled to the handle.
  • the balloon can optionally be coupled to a distal end portion of the shaft.
  • the balloon can optionally be configured to be inflated from a first, deflated state to a second, radially expanded, inflated state.
  • the balloon can optionally include a valve mounting portion for mounting the prosthetic valve in a radially compressed state.
  • the valve positioning structure can optionally extend at least partially over an exterior surface of the balloon, which can have a first end portion and a second end portion.
  • the valve positioning structure can optionally be configured to radially expand from a radially collapsed state to a radially expanded state when the balloon is inflated and then resiliently radially collapse from the radially expanded state to the radially collapsed state when the balloon is deflated.
  • a delivery system for delivering a prosthetic valve through vasculature of a patient can comprise: a radially expandable prosthetic valve and a delivery apparatus.
  • the delivery apparatus can comprise: a handle, a shaft, an expandable distal valve positioning structure, and an expandable proximal valve positioning structure.
  • the shaft can optionally be coupled to the handle and a balloon coupled to a distal end portion of the shaft.
  • the balloon can optionally be configured to be inflated from a first, deflated state to a second, radially expanded, inflated state.
  • the prosthetic valve can optionally be mounted on the balloon in a radially compressed state.
  • the expandable distal valve positioning structure can optionally be disposed on an exterior surface of a distal end portion of the balloon.
  • the expandable proximal valve positioning structure can optionally be disposed on an exterior surface of a proximal end portion of the balloon.
  • the distal and proximal valve positioning structures can optionally be configured to radially expand from a radially collapsed state to a radially expanded state when the balloon is inflated and then radially collapse from the radially expanded state to the radially collapsed state when the balloon is deflated.
  • a delivery system for delivering a prosthetic valve through vasculature of a patient can comprise: a radially expandable prosthetic valve and a delivery apparatus.
  • the delivery apparatus can comprise: a handle, a shaft, and an expandable valve positioning structure.
  • the shaft can optionally be coupled to the handle and a balloon coupled to a distal end portion of the shaft.
  • the balloon can optionally be configured to be inflated from a first, deflated state to a second, radially expanded, inflated state.
  • the prosthetic valve can optionally be mounted on the balloon in a radially compressed state.
  • the expandable valve positioning structure can optionally be disposed on an exterior surface of a portion of the balloon.
  • the valve positioning structure can be configured to radially expand from a radially collapsed state to a radially expanded state when the balloon is inflated and then resiliently radially collapse from the radially expanded state to the radially collapsed state when the balloon is deflated.
  • a delivery apparatus for delivering a prosthetic valve through vasculature of a patient can comprise: a handle, a balloon catheter, and a first valve positioning structure.
  • the balloon catheter can optionally comprise a shaft coupled to the handle and a balloon connected to a distal end portion of the shaft.
  • the balloon can optionally be configured to be inflated from an uninflated state to an inflated state.
  • the first valve positioning structure can optionally extend over an exterior surface of the balloon.
  • the first valve positioning structure can optionally comprise a first frame constructed of a shapememory material.
  • the first frame can optionally be shape set in a radially compressed configuration.
  • a delivery apparatus for delivering a prosthetic valve through vasculature of a patient can comprise: a handle, a shaft, a balloon, and a valve positioning system.
  • the shaft can optionally be coupled to the handle.
  • the balloon can optionally be coupled to a distal end portion of the shaft.
  • the balloon can optionally be configured to be inflated from a first, deflated state to a second, radially expanded, inflated state.
  • the balloon can optionally have a proximal end portion, a distal end portion, and a valve mounting portion disposed between the proximal and distal end portions for mounting the prosthetic valve in a radially compressed state.
  • the valve positioning structure can optionally comprise a frame, wherein the valve positioning structure can be positioned radially outward of the balloon, the valve positioning structure can optionally extend over the proximal end portion of the balloon, the valve mounting portion of the balloon, and the distal end portion of the balloon, and the valve positioning structure can optionally be configured to radially expand from a radially collapsed state to a radially expanded state when the balloon is inflated and then radially collapse from the radially expanded state to the radially collapsed state when the balloon is deflated.
  • a delivery apparatus for a prosthetic medical device can comprise a handle, a shaft, a balloon, and a valve positioning system.
  • the shaft can optionally be coupled to the handle.
  • the balloon can optionally be coupled to a distal end portion of the shaft.
  • the valve positioning structure can optionally extend at least partially over an outer surface of the balloon, wherein the valve positioning structure can optionally comprise a frame constructed of a shape-memory material.
  • a delivery apparatus for a prosthetic medical device can comprise: a handle, a shaft, a balloon, and a valve positioning structure.
  • the shaft can optionally be coupled to the handle.
  • the balloon can optionally be coupled to a distal end portion of the shaft and can optionally comprise an outer surface.
  • the valve positioning structure can optionally extend at least partially over the outer surface of the balloon and can comprise a frame that includes a plurality of struts.
  • the frame can optionally define an axial direction and a circumferential direction.
  • a delivery system can comprise: a balloon, an expandable distal valve positioning structure, an expandable proximal valve positioning structure, and a prosthetic heart valve.
  • the balloon can optionally comprise: an outer surface extending from a distal end to a proximal end of the balloon and a valve mounting portion disposed on the outer surface between the distal and proximal ends.
  • the expandable distal valve positioning structure can optionally extend over a distal portion of the outer surface of the balloon.
  • the expandable proximal valve positioning structure can optionally extend over a proximal portion of the outer surface of the balloon.
  • the prosthetic heart valve can optionally be crimped around the valve mounting portion of the balloon, wherein neither the distal valve positioning structure nor the proximal valve positioning structure can overlap an outer surface of the prosthetic heart valve.
  • a delivery apparatus comprises one or more of the components recited in Examples 1-165 below.
  • FIG. 1 is a side view of a prosthetic heart valve, according to one example.
  • FIG. 2A is a side view of a delivery apparatus for a prosthetic heart valve, according to one example.
  • FIG. 2B is a side view of a distal end portion of a delivery apparatus for a prosthetic heart valve, according to another example.
  • FIG. 3 is a side view of a distal end portion of the delivery apparatus of FIG. 2A having valve positioning structures, according to one example, shown with a balloon in an uninflated state.
  • FIG. 4A is a perspective view of the distal end portion of the delivery apparatus of FIG. 3, shown with the balloon in an uninflated state and a prosthetic heart valve in a radially crimped state on the balloon.
  • FIG. 4B is a perspective view of the distal end portion of the delivery apparatus of FIG. 4A, shown with the balloon in an inflated state and the prosthetic heart valve in a radially expanded state.
  • FIG. 5A is a side view of a distal valve positioning structure comprising a frame, according to one example.
  • FIG. 5B is a side view of a proximal valve positioning structure comprising a frame, according to one example.
  • FIG. 5C is a flattened view of a frame of the valve positioning structures of FIGS. 5A- 5B, according to one example.
  • FIG. 6A is a side view of a distal valve positioning structure, according to one example.
  • FIG. 6B is a side view of a proximal valve positioning structure, according to one example.
  • FIG. 7A is a side view of a distal end portion of a delivery apparatus having distal and proximal valve positioning structures, according to one example, shown with a balloon in an uninflated state.
  • FIG. 7B is a side view of a suture connected to a proximal end portion of the distal valve positioning structure of FIG. 7A, according to one example.
  • FIG. 7C is a side view of a suture connected to a proximal end portion of a valve positioning structure, according to one example.
  • FIG. 8A is a side view of a distal end portion of a portion delivery apparatus having a valve positioning structure, according to one example, shown with a balloon in an uninflated state.
  • FIG. 8B is a side view of the valve positioning structure of FIG. 8A, according to one example.
  • FIG. 9A is a side view of a distal end portion of a delivery apparatus having a valve positioning structure, according to one example, shown with a balloon in an uninflated state.
  • FIG. 9B is a side view of the distal end portion of the delivery apparatus of FIG. 9A, shown with the balloon in a partially radially expanded state.
  • FIG. 9C is a side view of the distal end portion of the delivery apparatus of FIGS. 9A- 9B, shown with the balloon in a radially expanded state.
  • FIG. 10A is a side view of a valve positioning structure, according to one example.
  • FIG. 10B is a flattened view of a frame of the valve positioning structure of FIG. 10 A.
  • FIG. 10C is a side view of a distal end portion of a delivery apparatus having the valve positioning structure of FIG. 10A, shown with a balloon in an uninflated state.
  • FIG. 10D is a side view of the distal end portion of the delivery apparatus of FIG.
  • FIG. 10E is a side view of the distal end portion of the delivery apparatus of FIGS.
  • FIG. 11 is a side view of a distal end portion of a delivery apparatus, according to one example, shown with a balloon in an inflated state.
  • FIG. 12 is a schematic profile view of balloons for a delivery apparatus, according to one example.
  • FIG. 13 is a flattened view of a frame of a valve positioning structure, according to one example.
  • FIG. 14A is a side view of a valve positioning structure, according to one example.
  • FIG. 14B is a flattened view of a frame of the valve positioning structure of FIG. 14A, according to one example.
  • FIG. 15 is a flattened view of a frame of a valve positioning structure, according to one example.
  • FIG. 16 is a flattened view of a frame of a valve positioning structure, according to one example.
  • FIG. 17 is a flattened view of a frame of a valve positioning structure, according to one example.
  • FIG. 18 is a flattened view of a frame of a valve positioning structure, according to one example.
  • FIG. 19 is a flattened view of a frame of a valve positioning structure, according to one example.
  • FIG. 20A is a side view of a distal end portion of a delivery apparatus, shown with the balloon in an uninflated state, according to one example.
  • FIG. 20B is a side view of the distal end portion of the delivery apparatus of FIG.
  • FIG. 20C is a flattened view of a frame of the valve positioning structure of the delivery apparatus of FIGS. 20A-20B, according to one example.
  • FIG. 21 is a flattened view of a frame of a valve positioning structure, according to one example.
  • FIG. 22 is a flattened view of a frame of a valve positioning structure, according to one example.
  • FIG. 23 is a flattened view of a frame of a valve positioning structure, according to one example.
  • FIG. 24A is a side view of a distal end portion of a delivery apparatus, shown with the balloon in an uninflated state, according to one example.
  • FIG. 24B is a side view of the distal end portion of the delivery apparatus of FIG. 24A, shown with the balloon in an inflated state, according to one example.
  • FIG. 24C is a flattened view of a frame of the valve positioning structure of the delivery apparatus of FIGS. 24A-24B, according to one example.
  • FIG. 25 is a flattened view of a portion of a frame of a valve positioning structure, according to one example.
  • FIG. 26 is a flattened view of a frame of a valve positioning structure, according to one example.
  • FIG. 27 is a flattened view of a frame of a valve positioning structure, according to one example.
  • FIG. 28 is a flattened view of a portion of a frame of a valve positioning structure, according to one example.
  • FIG. 29A is a side view of a distal end portion of a delivery apparatus, shown with the balloon in an uninflated state, according to one example.
  • FIG. 29B is a side view of the distal end portion of the delivery apparatus of FIG. 29A, shown with the balloon in an inflated state, according to one example.
  • FIG. 29C is a flattened view of a portion of the frame of the valve positioning structure of the delivery apparatus of FIGS. 29A-29B, according to one example.
  • FIG. 30 is a side view of a flattened distal valve positioning structure and a flattened proximal valve positioning structure coupled together via a plurality of tethers, according to one example.
  • FIG. 31 is a side view of a portion of a distal valve positioning structure and a portion of a proximal valve positioning structure coupled together via a single tether, according to one example.
  • FIG. 32 is a side view of a portion of a distal valve positioning structure and a portion of a proximal valve positioning structure coupled together via a single tether, according to one example.
  • FIG. 33 is a side view of a portion of a distal valve positioning structure and a portion of a proximal valve positioning structure coupled via a single tether, according to one example.
  • FIG. 34 is a side view of a portion of a distal valve positioning structure and a portion of a proximal valve positioning structure coupled via a single tether, according to one example.
  • proximal refers to a position, direction, or portion of a device that is closer to the user and further away from the implantation site.
  • distal refers to a position, direction, or portion of a device that is further away from the user and closer to the implantation site.
  • proximal motion of a device is motion of the device away from the implantation site and toward the user (for example, out of the patient’s body), while distal motion of the device is motion of the device away from the user and toward the implantation site (for example, into the patient’s body).
  • an implantable, expandable medical device for example, a prosthetic heart valve
  • tools, agents, or other therapy to a location within the body of a subject.
  • procedures in which the steerable catheters are useful include neurological, urological, gynecological, fertility (for example, in vitro fertilization, artificial insemination), laparoscopic, arthroscopic, transesophageal, transvaginal, transvesical, transrectal, and procedures including access in any body duct or cavity.
  • implants including stents, grafts, embolic coils, and the like; positioning imaging devices and/or components thereof, including ultrasound transducers; and positioning energy sources, for example, for performing lithotripsy, RF sources, ultrasound emitters, electromagnetic sources, laser sources, thermal sources, and the like.
  • Prosthetic valves disclosed herein can be radially compressible and expandable between a radially compressed state and a radially expanded state.
  • the prosthetic valves can be crimped on or retained by an implant delivery apparatus in the radially compressed state while being advanced through a patient’s vasculature on the delivery apparatus.
  • the prosthetic valve can be expanded to the radially expanded state once the prosthetic valve reaches the implantation site. It is understood that the prosthetic valves disclosed herein may be used with a variety of implant delivery apparatuses and can be implanted via various delivery procedures, examples of which will be discussed in more detail later.
  • some prosthetic heart valves can be retained by a delivery apparatus in the radially compressed state and advanced through a patient’s vasculature, such as to a native heart valve, by the delivery apparatus, such as the example delivery apparatus shown in FIG. 2A or FIG. 2B.
  • the prosthetic valve can be expanded to the radially expanded state once the prosthetic valve reaches the implantation site, for example, by expanding a balloon of the delivery apparatus.
  • the delivery apparatus can include structures that help position the prosthetic heart valve (or any other prosthetic medical device) on the distal end portion of the delivery apparatus.
  • an expandable valve positioning structure can be coupled to a surface (such as an external or internal surface) of the balloon of the delivery apparatus to hold or retain the prosthetic heart valve (or any other prosthetic medical device) in an axially fixed position relative to the delivery apparatus.
  • FIGS. 2A and 2B depict examples in which such structures are positioned inside of a balloon. In FIGS.
  • an external, expandable valve positioning structure (which is also referred to herein as an external, expandable shoulder) can be coupled to an external surface of the balloon of the delivery apparatus to hold or retain the prosthetic heart valve (or any other prosthetic medical device) in an axially fixed position relative to the delivery apparatus.
  • the structure can be configured with a tapered surface and/or a cross-sectional size that improves the ability of the delivery apparatus to advance the prosthetic heart valve (or any other prosthetic medical device) through an introducer sheath and/or the patient’s vasculature.
  • FIGS. 5A-5B, 6A-6B, 8B, 10A, and 14A show exemplary valve positioning structures in isolation.
  • FIGS. 5C, 10B, 13, and 14B-19, 20C-23, 24C-28, 29C, and 30-34 show flattened views of exemplary frames of valve positioning structures.
  • the devices and methods disclosed herein can, among other things, improve delivery apparatuses for prosthetic heart valves (or any other prosthetic medical device) by improving the positioning of the prosthetic heart valve (or any other prosthetic medical device) relative to the delivery apparatus and improving the ability for the delivery apparatus to advance through a patient’s vasculature.
  • FIG. 1 shows a prosthetic heart valve 10 (which is also referred to herein as a “prosthetic valve”), according to one example.
  • a prosthetic valve 10 which is also referred to herein as a “prosthetic valve”
  • Any of the prosthetic valves disclosed herein are adapted to be implanted in the native aortic annulus, although in other examples they can be adapted to be implanted in the other native annuluses of the heart (the pulmonary, mitral, and tricuspid valves).
  • the disclosed prosthetic valves also can be implanted within vessels communicating with the heart, including a pulmonary artery (for replacing the function of a diseased pulmonary valve, or the superior vena cava or the inferior vena cava (for replacing the function of a diseased tricuspid valve) or various other veins, arteries and vessels of a patient.
  • the disclosed prosthetic valves also can be implanted within a previously implanted prosthetic valve (which can be a prosthetic surgical valve or a prosthetic transcatheter heart valve) in a valve-in-valve procedure,
  • the disclosed prosthetic valves can be implanted within a docking or anchoring device that is implanted within a native heart valve or a vessel.
  • the disclosed prosthetic valves can be implanted within a docking device implanted within the pulmonary artery for replacing the function of a diseased pulmonary valve, such as disclosed in U.S. Publication No. 2017/0231756, which is incorporated by reference herein.
  • the disclosed prosthetic valves can be implanted within a docking device implanted within or at the native mitral valve, such as disclosed in PCT Publication No. W02020/247907, which is incorporated by reference herein.
  • the disclosed prosthetic valves can be implanted within a docking device implanted within the superior or inferior vena cava for replacing the function of a diseased tricuspid valve, such as disclosed in U.S. Publication No. 2019/0000615, which is incorporated by reference herein.
  • the prosthetic valve 10 can include a stent or frame 12, a valvular structure 14, an inner skirt 16, and/or a perivalvular outer sealing member or outer skirt 18.
  • the prosthetic valve 10 can have an inflow end portion 15, an intermediate portion 17, and an outflow end portion 19.
  • the inner skirt 16 can be arranged on and/or coupled to an inner surface of the frame 12 while the outer skirt 18 can be arranged on and/or coupled to an outer surface of the frame 12.
  • the valvular structure 14 can comprise three leaflets 40, collectively forming a leaflet structure, which can be arranged to collapse in a tricuspid arrangement, although in other examples there can be greater or fewer number of leaflets (for example, one or more leaflets 40).
  • the leaflets 40 can be secured to one another at their adjacent sides to form commissures 22 of the leaflet structure 14.
  • the lower edge of valvular structure 14 can have an undulating, curved scalloped shape and can desirably be secured to the inner skirt 16 by sutures (not shown). In other examples, the lower edge of the valvular structure 14 can have a different shape, for example, the lower edge of the valvular structure 14 can also be straight.
  • the leaflets 40 can be formed of pericardial tissue (for example, bovine pericardial tissue), biocompatible synthetic materials, or various other suitable natural or synthetic materials as known in the art and described in U.S. Patent No. 6,730,118, which is incorporated by reference herein.
  • the frame 12 can be radially compressible (collapsible) and expandable (for example, expanded configuration shown in FIG. 1 ) and comprise a plurality of interconnected struts 24.
  • a plurality of apices 26 that are spaced circumferentially apart are formed at the inflow end portion 15 and the outflow end portion 19 of the frame 12 (only the apices 26 at the outflow end portion 19 are visible in FIG. 1).
  • Each apex 26 is formed at a junction between two angled struts 24 at either the inflow end portion 15 or the outflow end portion 19.
  • FIG. 1 depicts a known frame design with apices 26 that form a U-shaped bend between the two angled struts 24.
  • an angle 30 between the two angled struts 24, connected at the apex 26, can be in a range of 90 to 120 degrees.
  • the frame design can correspond to that of the Sapien 3 transcatheter heart valve. That is, in some desirable examples, two additional rows of angled struts 24 can be hidden from view by the outer skirt 18, for a total of five rows of angled struts 24.
  • the frame 12 can be configured differently.
  • the frame 12 may comprise a total of two rows of angled struts 24, three rows of angled struts 24, four rows of angled stmts 24, or a number of rows of angled stmts exceeding five, such as six, seven or eight.
  • a row of cells formed at the outflow end of the frame can be enlarged compared to other rows of cells.
  • the frame 12 can be made up entirely of equally sized cells.
  • other rows in addition to or alternatively to the outflow row of cells can be enlarged compared to other rows of cells.
  • the enlarged cells at the outflow end can have a hexagonal shape.
  • the cells can be shaped differently, for example some or all of the cells have a diamond shape. In some examples, all cells can share the same shape.
  • the frame can comprise a mix of rows of cells of different shapes, for example a combination of hexagonal cells and diamond shaped cells.
  • the frame 12 can be formed with a plurality of circumferentially spaced slots, or commissure windows 20 that are adapted to mount the commissures 22 of the valvular structure 14 to the frame 12.
  • the frame 12 can comprise commissure attachment features other than slots or commissure windows 20.
  • the frame 12 does not comprise distinct commissure features.
  • the commissures 22 can be attached (for example, sutured) to a separate connection member, such as a fabric member, spanning a cell of the frame 12.
  • the frame 12 can be made of any of various suitable plastically-expandable materials (for example, stainless steel, etc.) or selfexpanding materials (for example, Nitinol).
  • the frame 12 When constructed of a plastically-expandable material, the frame 12 (and thus the prosthetic valve 10) can be crimped to a radially collapsed configuration on a delivery catheter or apparatus and then expanded inside a patient by an inflatable balloon or equivalent expansion mechanism.
  • the frame 12 When constructed of a selfexpandable material, the frame 12 (and thus the prosthetic valve 10) can be crimped to a radially collapsed configuration and restrained in the collapsed configuration by insertion into a sheath or equivalent mechanism of a delivery catheter. Once inside the body, the prosthetic valve can be advanced from the sheath, which allows the prosthetic valve to expand to its functional size.
  • Suitable plastically-expandable materials that can be used to form the frames disclosed herein (for example, frame 12, frame 230, etc.) include, metal alloys, polymers, or combinations thereof.
  • Example metal alloys can comprise one or more of the following: nickel, cobalt, chromium, molybdenum, titanium, or other biocompatible metal.
  • the frame 12 can comprise stainless steel.
  • the frame 12 can comprise cobalt-chromium.
  • the frame 12 can comprise nickel-cobalt- chromium.
  • the frame 12 comprises a nickel-cobalt-chromium- molybdenum alloy, such as MP35NTM (tradename of SPS Technologies), which is equivalent to UNS R30035 (covered by ASTM F562-02).
  • MP35NTM/UNS R30035 comprises 35% nickel, 35% cobalt, 20% chromium, and 10% molybdenum, by weight.
  • Any one of the skirts 16 and 18 can be wholly or partly formed of any suitable biological material, synthetic material (for example, any of various polymers), or combinations thereof.
  • the skirts 16 and/or 18 can comprise a fabric having interlaced yarns or fibers, such as in the form of a woven, braided, or knitted fabric.
  • the fabric can have a plush nap or pile.
  • fabrics having a plush nap or pile include velour, velvet, velveteen, corduroy, terry cloth, fleece, etc.
  • the skirts 16 and/or 18 can comprise a fabric without interlaced yams or fibers or randomly interlaced yams or fibers, such as felt or an electrospun fabric.
  • Exemplary materials that can be used for forming such fabrics (with or without interlaced yarns or fibers) include, without limitation, polyethylene (PET), ultra-high molecular weight polyethylene (UHMWPE), polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), polyamide etc.
  • the skirts 16 and/or 18 can comprise a non-textile or nonfabric material, such as a film made from any of a variety of polymeric materials, such as PTFE, PET, polypropylene, polyamide, polyetheretherketone (PEEK), polyurethane (such as thermoplastic polyurethane (TPU)), etc.
  • the skirts 16 and/or 18 can comprise a sponge material or foam, such as polyurethane foam.
  • the skirts 16 and/or 18 can comprise natural tissue, such as pericardium (for example, bovine pericardium, porcine pericardium, equine pericardium, or pericardium from other sources).
  • pericardium for example, bovine pericardium, porcine pericardium, equine pericardium, or pericardium from other sources.
  • FIG. 2A shows a delivery apparatus 100, according to an example, that can be used to implant an expandable prosthetic valve (for example, prosthetic valve 10 of FIG. 1 or any of the other prosthetic medical device described herein).
  • the delivery apparatus 100 is specifically adapted for use in introducing a prosthetic valve into a heart.
  • the specific examples of delivery apparatuses are disclosed herein as configured for use with prosthetic heart valves (for example, the prosthetic heart valve 10 of FIG. 1 or any other prosthetic heart valve disclosed herein)
  • the exemplary delivery apparatus can additionally or alternatively be configured for use with any other prosthetic medical device (for example, a stent, a graft, an stents, an embolic coil, and/or any other implant).
  • the delivery apparatus 100 in the illustrated example of FIG. 2 A is a balloon catheter comprising a handle 102 and a steerable, outer shaft 104 extending distally from the handle 102.
  • the delivery apparatus 100 can further comprise an intermediate shaft 106 (which also may be referred to as a balloon shaft) that extends proximally from the handle 102 and distally from the handle 102, the portion extending distally from the handle 102 also extending coaxially through the outer shaft 104.
  • the delivery apparatus 100 can further comprise an inner shaft 108 extending distally from the handle 102 coaxially through the intermediate shaft 106 and the outer shaft 104 and proximally from the handle 102 coaxially through the intermediate shaft 106.
  • the outer shaft 104 and the intermediate shaft 106 can be configured to translate (for example, move) longitudinally, along a central longitudinal axis 120 of the delivery apparatus 100, relative to one another to facilitate delivery and positioning of a prosthetic valve at an implantation site in a patient’s body.
  • the intermediate shaft 106 can include a proximal end portion 110 that extends proximally from a proximal end of the handle 102, to an adaptor 112.
  • a rotatable knob 114 can be mounted on the proximal end portion 110 and can be configured to rotate the intermediate shaft 106 around the central longitudinal axis 120 and relative to the outer shaft 104.
  • the adaptor 112 can include a first port 138 configured to receive a guidewire therethrough and a second port 140 configured to receive fluid (for example, inflation fluid) from a fluid source.
  • the second port 140 can be fluidly coupled to an inner lumen of the intermediate shaft 106.
  • the intermediate shaft 106 can further include a distal end portion that extends distally beyond a distal end of the outer shaft 104 when a distal end of the outer shaft 104 is positioned away from an inflatable balloon 118 of the delivery apparatus 100.
  • a distal end portion of the inner shaft 108 can extend distally beyond the distal end portion of the intermediate shaft 106.
  • the balloon 118 can extend over the inner shaft 108.
  • the balloon 118 can include a distal end portion 118a, an intermediate portion 118b, and a proximal portion 118c.
  • the distal end portion 118a of the balloon 118 can be coupled to a distal end portion of the delivery apparatus 100, such as to a nose cone 122 (as shown in FIG. 2A), or to an alternate component at the distal end portion of the delivery apparatus 100 (for example, a distal shoulder).
  • the proximal end portion 118c of the balloon 118 can be coupled to a distal end portion of the intermediate shaft 106.
  • the intermediate portion 118b of the balloon 118 and the inner shaft 108 can form or define a valve mounting portion 124 of a distal end portion of the delivery apparatus 100.
  • the distal end portion 118a of the balloon 118 can optionally overlay a distal shoulder 126 of the delivery apparatus 100.
  • the valve mounting portion 124 and the intermediate portion of the balloon 118 can be configured to receive a prosthetic heart valve in a radially compressed state.
  • a prosthetic valve for example, prosthetic valve 150
  • the intermediate portion 118b of the balloon is alternatively be referred to herein as a valve mounting portion of the balloon 118.
  • the balloon shoulder assembly including the distal shoulder 126, is configured to maintain the prosthetic heart valve 150 (or other medical device) at a fixed position on the balloon 118 during delivery through the patient’s vasculature.
  • the prosthetic heart valve 150 can be maintained at a fixed position on the balloon 118 by other means, such as by a distal end portion of the tip 122.
  • the distal shoulder 126 is optional.
  • the outer shaft 104 can optionally include a distal tip portion 128 mounted on its distal end.
  • the outer shaft 104 and the intermediate shaft 106 can be translated axially relative to one another to position the distal tip portion 128 adjacent a proximal side of the valve mounting portion 124, when the prosthetic valve 150 is mounted in the radially compressed state on the valve mounting portion 124 (as shown in FIG. 2A) and during delivery of the prosthetic valve 150 to the target implantation site.
  • the distal tip portion 128 can be configured to resist movement of the prosthetic valve 150 relative to the balloon 118 proximally, in the axial direction, when the distal tip portion 128 is arranged adjacent a proximal side of the valve mounting portion 124.
  • An annular space can be defined between an outer surface of the inner shaft 108 and an inner surface of the intermediate shaft 106 and can be configured to receive fluid from a fluid source via the second port 140 of the adaptor 112.
  • the annular space can be fluidly coupled to a fluid passageway formed between the outer surface of the distal end portion of the inner shaft 108 and an inner surface of the balloon 118.
  • fluid from the fluid source can flow to the fluid passageway from the annular space to inflate the balloon 1 18 (for example, from a first, deflated state to a second, radially expanded, inflated state) and radially expand and deploy the prosthetic valve 150.
  • An inner lumen of the intermediate shaft 106 can be configured to receive a guidewire therethrough, for navigating the distal end portion of the delivery apparatus 100 to the target implantation site.
  • the handle 102 can optionally include a steering mechanism configured to adjust the curvature of the distal end portion of the delivery apparatus 100.
  • the handle 102 includes an adjustment member, such as the illustrated rotatable knob 160, which in turn is operatively coupled to the proximal end portion of a pull wire.
  • the pull wire can extend distally from the handle 102 through the outer shaft 104 and has a distal end portion affixed to the outer shaft 104 at or near the distal end of the outer shaft 104.
  • Rotating the knob 160 can increase or decrease the tension in the pull wire, thereby adjusting the curvature of the distal end portion of the delivery apparatus 100.
  • a pull wire can extend through one of the inner shaft 108 or the intermediate or balloon shaft 106.
  • outer shaft 104 can be dispensed with, and the optional means for adjusting the curvature of the distal end portion of the delivery apparatus 100 are provided in other form, such as by being part of the inner shaft 108 or the intermediate or balloon shaft 106.
  • the handle 102 can optionally further include an adjustment mechanism 161 including an adjustment member, such as the illustrated rotatable knob 162, and an associated locking mechanism including another adjustment member, configured as a rotatable knob 178.
  • the adjustment mechanism 161 is configured to adjust the axial position of the intermediate shaft 106 relative to the outer shaft 104 (for example, for fine positioning at the implantation site). Further details on the delivery apparatus 100 can be found in WIPO Publication No. WO2022/046585, which are incorporated by reference herein.
  • FIG. 2 A shows an example of the delivery apparatus 100 being used for “on-balloon” delivery.
  • the prosthetic valve 150 is radially compressed (or “crimped”) directly onto the valve mounting portion 124 of the delivery apparatus 100 (for example, around the intermediate portion 118b of the balloon 1 18) prior to insertion of the prosthetic valve 150 and the delivery apparatus 100 into a patient’s vasculature.
  • FIG. 2B shows an example of the delivery apparatus 100 being used for “off-balloon” delivery.
  • the prosthetic valve 150 is radially crimped offset from the valve mounting portion 124 (which is also referred to herein as an “offset position”), such as on the intermediate shaft 106 and/or on a proximal or a distal end portion of the balloon 118.
  • the delivery apparatus 100 and the prosthetic valve 150 are inserted through an introducer sheath and into the patient’s vasculature with the prosthetic valve 150 in this offset position. Once inside the patient’s vasculature (for example, within the descending aorta), the prosthetic valve 150 can be moved from the offset position to the valve mounting portion 124 of the balloon 118. This can be accomplished by various different means.
  • the prosthetic heart valve 150 can be moved from the offset position to the valve mounting portion 124 of the balloon 118 by moving the intermediate shaft 106 proximally relative to the outer shaft 104 or moving the outer shaft 104 distally relative to the intermediate shaft 106 while applying a distally-directed force against a proximal end 150p of the prosthetic valve 150 with a distal end of the distal tip portion 128.
  • the adjustment mechanism 161 can be used to move the intermediate shaft 106 relative to the outer shaft 104 for repositioning the prosthetic valve 150. Thereafter, the delivery apparatus 100 can be further advanced to the target implantation site (for example, the native aortic annulus) and the prosthetic valve 150 can be deployed.
  • the delivery apparatus 100 optionally can include a valve mounting member 168 positioned inside the balloon 118 along the valve mounting portion 124 to help maintain the position of the prosthetic valve 150 on the balloon 118.
  • the optional valve mounting member 168 can also be located at the proximal end portion 118c.
  • moving the prosthetic heart valve 150 relative to the balloon 118 can be accomplished by various means, including but not limited to the outer shaft 104 and the distal end of the distal tip portion 128.
  • different means for moving the prosthetic heart valve 150 from the offset position to the valve mounting portion 124 of the balloon 1 18 can be provided, including but not limited to a tether releasably connected to the prosthetic heart valve 150 and extending to a proximal end of the delivery apparatus 100, such as to the handle 102.
  • the distal shoulder 126 and the outer shaft 104 are optional.
  • the distal shoulder 126 and outer shaft 104 are also optional.
  • FIG. 2B also shows a pull wire 166 (which can extend through a lumen of the shaft 104) having a distal end 166d that is fixed relative to a steerable section 164 of the outer shaft 104.
  • the proximal end of the pull wire 166 can be operatively connected to the adjustment knob 160 (FIG. 2B) for adjusting the tension in the pull wire 166 for controlling the curvature of the steerable section 164 of the outer shaft 104.
  • FIG. 2B shows a delivery apparatus used for off-balloon delivery of a prosthetic valve.
  • a distal end of the prosthetic valve 150 is positioned adjacent a distal end of the valve mounting portion 124, that is, adjacent the distal shoulder 126.
  • the distal shoulder 126 can be configured to resist movement of the prosthetic valve 150 relative to the balloon 118 distally, in the axial direction, for example, when the balloon 118 is initially expanded.
  • the distal shoulder 126 is positioned within the balloon 118, such that the balloon 118 expands in the radially outwards direction and away from the distal shoulder 126 as the balloon 118 expands in the radially outwards direction and deploys the prosthetic heart valve 150.
  • the distal shoulder 126 also functions to protect and shield the leading edge (in other words, the distal edge) of the prosthetic valve 150 from contacting native anatomy as the delivery apparatus 100 is advanced through the patient’s vasculature.
  • a distal end portion of the tip 122 for example, in the form of a blunt proximal end as opposed to the generally tapered distal end depicted in the figures, can perform the same function.
  • the outer shaft 104 can be positioned relative to the intermediate shaft 106 such that the distal tip portion 128 is positioned adjacent a proximal end of the valve mounting portion 124 and adjacent a proximal end of the prosthetic valve 150. In some examples, the distal end of the tip portion 128 can abut the proximal end of the prosthetic valve 150. As such, in some examples, the distal tip portion 128 is also referred to herein as a “proximal shoulder.” In this position, the outer shaft 104 is disposed around and covers a portion of the balloon 118.
  • the proximal shoulder 128 can be configured to resist movement of the prosthetic valve 150 relative to the balloon 118 proximally, in the axial direction, for example, as the delivery apparatus 100 and prosthetic valve 150 are advanced through the patient’s vasculature and/or an introducer sheath.
  • the outer shaft 104 prior to expanding the balloon 118, the outer shaft 104 must be retracted proximally relative to the intermediate shaft 106 to enable the balloon 118 to be fully inflated (for example, without interference with the outer shaft 104). This is due in part to the outer shaft 104 and/or the proximal shoulder 128 not being expandable when the balloon 118 is radially expanded.
  • the distal tip portion 128 of the outer shaft 104 can be used to push the prosthetic valve 150 onto the valve mounting portion 124 once the prosthetic valve 150 and the distal end portion of the delivery apparatus 100 are inserted into the patient’s vasculature.
  • FIGS. 2A and 2B depict delivery apparatus 100 having structures positioned inside of a balloon, such as the distal shoulder 126, configured to maintain the axial position of a prosthetic valve (for example, any one of prosthetic valve 10 and prosthetic valve 150) relative to the delivery apparatus.
  • a prosthetic valve for example, any one of prosthetic valve 10 and prosthetic valve 150
  • These structures while effective, involve relatively complex manufacturing steps. For example, once the balloon 118 has been formed or shaped, it can be difficult to insert the distal shoulder 126 inside the balloon 118.
  • the prosthetic valve 150 desirably is positioned to be substantially coaxial with the annulus of the native heart valve so that the prosthetic valve 150 can be evenly expanded and securely anchored within the annulus.
  • the outer shaft 104 provides means for adjusting the curvature of the distal end of the delivery apparatus 100, this can occur if the steerable section 164 of the outer shaft 104 is retained in a curved state via increased tension in the pull wire (for example, pull wire 166) while the outer shaft 104 is retracted. Retracting the outer shaft 104 retracts the steerable section 164 farther away from the balloon 118 and the prosthetic valve 150.
  • the distal end portion of the intermediate shaft 106 and the distal end portion of the inner shaft 108 may deflect slightly relative to the steerable section 164. As a result, the prosthetic valve 150 may no longer be coaxial with the native annulus.
  • a prosthetic valve for example, prosthetic valve 10, prosthetic valve 150
  • a delivery apparatus for example, delivery apparatus 100
  • a balloon for example, balloon 118
  • an outer shaft for example, outer shaft 104
  • these structures can be configured to expand as the balloon expands, and in some examples, these structures can help maintain the position of the prosthetic valve relative to the delivery apparatus during radial expansion of the prosthetic valve.
  • these structures can be used in lieu of a distal shoulder (for example, distal shoulder 126) and/or a proximal shoulder (for example, proximal shoulder 128).
  • such external (i.e. positioned outside of or disposed at least partially around a balloon) structures configured to maintain the axial position of the prosthetic valve relative to the delivery apparatus, can be combined with any one or more structures positioned inside of the balloon for the same purpose, such as the structures described above in conjunction with FIGS. 2A and 2B
  • FIG. 3 illustrates the valve mounting portion 124 of the distal end portion of the delivery apparatus 100, according to another example.
  • the delivery apparatus 100 of FIG. 3 includes an expandable, external distal valve positioning structure 226 (also referred to herein as a “distal shoulder”) and an expandable, external proximal valve positioning structure 228 (also referred to herein as a “proximal shoulder”).
  • the exemplary external (in other words, positioned outside of or disposed at least partially around a balloon) structures can be configured to maintain the axial position of the prosthetic heart valve relative to the delivery apparatus.
  • the distal valve positioning structure 226 extends at least partially over the distal portion 118a of the balloon 118 and the proximal valve positioning structure 228 extends at least partially over the proximal portion 118c of the balloon 118.
  • the delivery apparatus 100 shown in FIG. 3 can optionally exhibit any one or more of the features described with respect to FIGS. 2 A and 2B.
  • the distal valve positioning structure 226 and the proximal valve positioning structure 228 are shown, other examples can only have one of these two external valve positioning structures 226, 228.
  • an external valve positioning structure at one of the distal portion 118a or the proximal portion 118c can be combined with an internal valve positioning structure at the respective other of the distal portion 118a or the proximal portion 118c, such as any one of the internal valve positioning structures discussed above with respect to FIGS. 2A and 2B (for example, distal shoulder 126).
  • valve positioning structures 226, 228 are shown to extend over portions of the outer surface of the balloon 118, in some examples, the valve positioning structures 226, 228 are not adhered, fixed, or otherwise attached to the outer surface of the balloon 118. It should be understood that, similarly, any other valve positioning structure herein need not be adhered, fixed, fastened, or otherwise attached to the outer surface of the balloon 118.
  • the valve positioning structures 226, 228 can contact the outer surface of the balloon 118, but the valve positioning structures 226, 228 are not adhered, fixed, fastened, or otherwise attached to the outer surface of the balloon 118, such that the valve positioning structures 226, 228 can freely move relative to the outer surface as the balloon 118 is inflated.
  • valve positioning structures 226, 228 can be adhered, fixed, or otherwise attached to the outer surface of the balloon.
  • the internal distal shoulder 126 can be excluded.
  • any delivery apparatus or delivery system disclosed herein can lack the internal distal shoulder 126.
  • any one of the valve positioning structures disclosed herein or any portion(s) thereof can comprise a super-elastic and/or shape-memory material and can be shape set in a radially collapsed configuration (which is also referred to herein as a “radially collapsed state,” “radially compressed state,” and/or “radially compressed configuration”), such that the valve positioning structure can expand to a radially expanded configuration (which is also referred to herein as a “radially expanded state”) upon inflation of the balloon 118 and return to the radially collapsed configuration when the balloon is deflated, as further described below.
  • any one of the disclosed valve positioning structures can be made of Nitinol or can be made of a shape-memory polymer.
  • the distal valve positioning structure 226 comprises an annular frame 230, which is further described with reference to FIG. 5C.
  • the distal valve positioning structure 226 can be provided in a different form, including but not limited to a polymeric (for example, elastomeric) coating as described elsewhere herein.
  • the distal valve positioning structure 226 can optionally be coupled at its distal end to the nose cone 122.
  • the distal valve positioning structure 226 can have an outer diameter that is greater than an outer diameter of the prosthetic valve 150 in its radially compressed state, as shown in FIG. 4A.
  • the outer profile of the distal valve positioning structure 226 enables the delivery apparatus 100 to be more easily advanced through an introducer sheath and/or a patient’ s vasculature in a manner that protects against undesirable contact between the leading edge (the distal end) of the prosthetic valve 150 and the patient’s vasculature and between the leading edge of the prosthetic valve 150 and an inner surface of the introducer sheath.
  • the greater outer diameter of the distal valve positioning structure 226 relative to the outer diameter of the prosthetic heart valve 150 can help pre-dilate the introducer sheath ahead of the prosthetic valve 150 as the prosthetic valve (mounted on the delivery apparatus) is inserted into the sheath.
  • the greater outer diameter of the distal valve positioning structure 226 relative to the outer diameter of the prosthetic heart valve 150 can help further minimize migration of the prosthetic heart valve 150 relative to the balloon 118 (for example, distal migration) during inflation of the balloon.
  • distal valve positioning structures and proximal valve positioning portions disclosed herein that include an outer diameter that is greater than the outer diameter of the radially compressed prosthetic valve.
  • the distal and/or proximal valve positioning structures 226, 228 can have an outer diameter equal to or smaller than the outer diameter of the radially compressed prosthetic valve 150.
  • the external distal and/or proximal valve positioning structures 226, 228 can be configured to prevent further axial movement of the prosthetic valve 150 upon contact with a portion of an internal surface of the prosthetic valve 150.
  • the proximal valve positioning structure 228 can comprise the frame 230. As shown, the proximal end of the proximal valve positioning structure 228 is coupled to the intermediate shaft 106.
  • the proximal valve positioning structure 228 can be configured to counteract proximally-directed forces applied by the prosthetic valve 150 during delivery of the prosthetic valve 150 (for example, through an introducer sheath and/or a patient’s vasculature), thereby maintaining the positioning of the prosthetic valve 150 on the balloon 118 as it is advanced through an introducer sheath and the patient’ s vasculature.
  • the frame 230 of the proximal valve positioning structure 228 and the frame 230 of the distal valve positioning structure 226 can be the same frame 230 shape set in different configurations.
  • the frame 230 can be shape set in a distal configuration to form the distal valve positioning structure 226, and the frame 230 can be shape set in a proximal configuration to form the proximal valve positioning structure 228.
  • the distal valve positioning structure 226 and the proximal valve positioning structure 228 can comprise the same frame 230 shape set in the same configuration, such that the proximal valve positioning structure 228 and the distal valve positioning structure 226 are interchangeable.
  • one or both of the distal and proximal valve positioning structure 226, 228 can be similarly shape-set, but can be provided in a form different from the frame 230.
  • an external valve positioning structure made from shape-memory polymer can be provided, for example, as a continuous (in other words, free of openings such as those of frame 230) polymeric (for example, elastomeric) coating as described elsewhere herein.
  • the frame 230 (and any other frame disclosed herein) can be a unitary and/or fastener- free structure that can be formed from a single piece of material (for example, Nitinol), such as in the form of a tube.
  • the frame 230 can comprise a plurality of struts arranged to form a plurality of cells.
  • the plurality of struts and cells can be formed by removing portions (for example, via laser cutting) of the single piece of material.
  • the frame 230 can comprise struts connected by means of additional fasteners and/or hinges, including but not limited to those found in mechanically-expandable prosthetic heart valves.
  • the frame 230 can be formed of a plurality of interwoven or otherwise interlaced wires, including braided wires.
  • the prosthetic valve 150 can be radially compressed around the intermediate portion 118b of the balloon 118 between the distal valve positioning structure 226 and the proximal valve positioning structure 228 for delivery through the patient’s vasculature.
  • the distal valve positioning structure 226 and the proximal valve positioning structure 228 resist or prevent axial movement of the prosthetic valve 150 relative to the balloon 118 (for example, distal migration), and thereby maintain the prosthetic valve 150 at its desired location on the balloon 118 until deployment.
  • the valve positioning structures 226, 228 are sized such that there can be gaps between the distal end of the prosthetic valve 150 and the adjacent proximal end of the distal valve positioning structure 226 and between the proximal end of the prosthetic valve 150 and the adjacent distal end of the proximal valve positioning structure 228.
  • the presence of these gaps can facilitate radial expansion of the prosthetic valve 150 without interference from the valve positioning structures 226, 228 upon inflation of the balloon 118.
  • one of or both the valve positioning structures 226, 228 can be sized such that the distal end of the prosthetic valve 150 abuts the adjacent proximal end of the distal valve positioning structure 226 and/or the proximal end of the prosthetic valve 150 abuts the adjacent distal end of the proximal valve positioning structure 228 when the prosthetic valve 150 is radially compressed around the intermediate portion 118b of the balloon 118.
  • the distal valve positioning structure 226 nor the proximal valve positioning structure 228 overlap or extend over an outer surface of the prosthetic valve 150 when the prosthetic valve 150 is crimped onto the balloon 118.
  • At least one of the distal valve positioning structure 226 and the proximal valve positioning structure 228 can at least partially overlap at least part of the prosthetic heart valve 150 or vice versa.
  • at least one or both of the distal valve positioning structure 226 and the proximal valve positioning structure 228 can be shape set such that the prosthetic heart valve 150 can be crimped over at least an adjacent end portion of at least one of the distal valve positioning structure 226 and the proximal valve positioning structure 228 with an intermediate portion of the prosthetic valve between the opposing end portions in contact with the balloon (that is, a distal end portion of the prosthetic valve can overlap an adjacent end portion of the distal valve positioning structure 226 and/or a proximal end portion of the prosthetic valve can overlap an adjacent end portion of the proximal valve positioning structure 228).
  • valve positioning structures 226, 228 can radially expand under the force of the balloon 118 from their radially collapsed state (FIG. 4A) to a radially expanded state (FIG. 4B).
  • the valve positioning structures 226, 228 can be shape set in the radially collapsed state.
  • the valve positioning structures 226, 228 can revert to the radially collapsed state of FIG. 4A under their own resiliency, which in some examples can beneficially facilitate the retrieval of the delivery apparatus 100 from the patient’s vasculature.
  • the term “resiliency” refers to the ability of a structure to deform to a deformed shape or state in response to an external force and elastically return to a default or relaxed shape or state after the external force is removed. It should be understood that any valve positioning structure disclosed herein can revert back to a radially collapsed or compressed state under its own resiliency. In some examples, the deformation of one or both of the valve positioning structures 226, 228 from the compressed to the expanded configurations and vice versa can be achieved substantially without substantial plastic deformation (in other words, substantially elastically). Such elastic valve positioning structures 226, 228 can be provided, for example, in the form of an elastomeric coating disposed on portions of balloon 118.
  • valve positioning structures 226, 228 are present in the example of FIGS. 3-4B, in some examples, one of the valve positioning structures 226, 228 can be omitted.
  • the delivery apparatus 100 can include the distal valve positioning structure 226 but not the proximal valve positioning structure 228. In some examples, the delivery apparatus 100 can include the proximal valve positioning structure 228 but not the distal valve positioning structure 226.
  • the prosthetic valve 150 can be initially radially compressed on the valve mounting portion 124 of the balloon 118 for performing an on-balloon delivery procedure.
  • the prosthetic valve 150 can be crimped offset the valve mounting portion 124 of the balloon 118 for performing an off- balloon delivery procedure.
  • FIG. 5A is a side view of the distal valve positioning structure 226 in the radially collapsed state.
  • FIG. 5B is a side view of the proximal valve positioning structure 228 in the radially collapsed state.
  • Each one of the distal valve positioning structure 226 and the proximal valve positioning structure 228 can comprise the frame 230, which is best illustrated in a flattened configuration in FIG. 5C.
  • the frame 230 can be shape set in a first configuration (a “distal configuration”) to form the distal valve positioning structure 226 or shape set in a second configuration (a “proximal configuration”) to form the proximal valve positioning structure 228.
  • the frame 230 of the distal valve positioning structure 226 can have the shape shown in FIG. 5B and the frame 230 of the proximal valve positioning structure 228 can have the shape shown in FIG. 5A.
  • each of the distal valve positioning structure 226 and the proximal valve positioning structure 228 can comprise the frame 230 shape set in the same configuration, such that the distal valve positioning structure 226 and the proximal valve positioning structure 228 are interchangeable.
  • using a standard frame for example, frame 230
  • the distal valve positioning structure 226 and the proximal valve positioning structure 228 can beneficially decrease the number of unique parts needed to manufacture the delivery apparatus 100 and/or increase interchangeability among the parts of the delivery apparatus 100.
  • the frame 230 can have a different shape than the shape(s) depicted in the figures.
  • the shape of the distal valve positioning and/or proximal positioning structures 226, 228 can be specifically adapted to the shape of the respective ends of the prosthetic heart valve (for example, any one of prosthetic valve 10 and prosthetic valve 150).
  • the frame 230 can comprise a plurality of struts that includes a first plurality of struts 232, a second plurality of struts 234, a third plurality of struts 236, a fourth plurality of struts 238, a fifth plurality of struts 240, and a sixth plurality of struts 242.
  • the first plurality of struts 232 (which are also referred to herein as a “plurality of angled linear struts,” a “plurality of angled struts,” and/or a “plurality of linear struts”) can be arranged into a first row 244 that extends in a circumferential direction of the frame 230. Each one of the first plurality of struts 232 can be oriented at an angle relative to an axial direction of the frame 230. Each one of the first plurality of struts 232 can comprise a distal end and a proximal end.
  • the distal ends of adjacent ones of the first plurality of struts 232 can be connected at curved or rounded distal apices 256 that define a distal end of the frame 230.
  • the proximal ends of adjacent ones of the first plurality of struts 232 can be connected at junctions 258 (which are also referred to herein as “unions”).
  • the frame 230 can have a different configuration.
  • the frame 230 can have a greater or lesser number of rows than the depicted number of rows.
  • the cells formed by the struts 232, 234, 236, 238, 240, 242 can have a different shape than depicted.
  • the second plurality of struts 234 (which are also referred to herein as a “plurality of angled linear struts,” a “plurality of angled struts,” and/or a “plurality of linear struts”) can be arranged in a second row 246 that extends in the circumferential direction of the frame 230 and is proximally disposed relative to the first row 244. Each one of the second plurality of struts 234 can be oriented at an angle relative to the axial direction of the frame 230. Each one of the second plurality of struts 234 can comprise a distal end and a proximal end.
  • junctions 258 The distal ends of adjacent ones of the second plurality of struts 234 can be connected at the junctions 258.
  • junctions 260 which are also referred to herein as “unions”.
  • the third plurality of struts 236 (which are also referred to herein as a “plurality of angled linear struts,” a “plurality of angled struts,” and/or a “plurality of linear struts”) can be arranged in a third row 248 that extends in the circumferential direction of the frame 230 and is proximally disposed relative to the second row 246.
  • Each one of the third plurality of struts 236 can be oriented at an angle relative to the axial direction of the frame 230.
  • Each one of the third plurality of struts 236 can comprise a distal end and a proximal end.
  • junctions 260 The distal ends of adjacent ones of the third plurality of struts 236 can be connected at junctions 260.
  • junctions 262 which are also referred to herein as “unions”.
  • the fourth plurality of struts 238 (which are also referred to herein as a “plurality of angled linear struts,” a “plurality of angled struts,” and/or a “plurality of linear struts”) can be arranged in a fourth row 250 that extends in the circumferential direction of the frame 230 and is proximally disposed relative to the third row 248.
  • Each one of the fourth plurality of struts 238 can be oriented at an angle relative to the axial direction of the frame 230.
  • Each one of the fourth plurality of struts 238 can comprise a distal end and a proximal end.
  • junctions 262 The distal ends of adjacent ones of the fourth plurality of struts 238 can be connected at junctions 262.
  • junctions 264 which are also referred to herein as “unions”.
  • the fifth plurality of struts 240 (which are also referred to herein as a “plurality of angled linear struts,” a “plurality of angled struts,” and/or a “plurality of linear struts”) can be arranged in a fifth row 252 that extends in the circumferential direction of the frame 230 and is proximally disposed relative to the fourth row 250.
  • Each one of the fifth plurality of struts 240 can be oriented at an angle relative to the axial direction of the frame 230.
  • Each one of the fifth plurality of struts 240 can comprise a distal end and a proximal end.
  • the distal ends of adjacent ones of the fifth plurality of struts 240 can be connected at junctions 264.
  • the proximal ends of adjacent ones of the fifth plurality of struts 240 can be connected at junctions 266 (which are also referred to herein as “unions”).
  • the sixth plurality of struts 242 (which are also referred to herein as a “plurality of angled linear struts,” a “plurality of angled struts,” and/or a “plurality of linear struts”) can be arranged in a sixth row 254 that extends in the circumferential direction of the frame 230 and is proximally disposed relative to the fifth row 252. Each one of the sixth plurality of struts 242 can be oriented at an angle relative to the axial direction of the frame 230. Each one of the sixth plurality of struts 242 can comprise a distal end and a proximal end.
  • the distal ends of adjacent ones of the sixth plurality of struts 242 can be connected at junctions 266.
  • the proximal ends of adjacent ones of the sixth plurality of struts 242 can be connected at curved or rounded proximal apices 268 that define a proximal end of the frame 230.
  • the struts of the frame 230 can be arranged and/or connected to form a plurality of cells.
  • the first and second pluralities of struts 232, 234 can connect to each other to form a first circumferentially-extending row of cells 270.
  • the third and fourth pluralities of struts 236, 238 can be connected to each other to form a second row of cells 272.
  • the fifth and six pluralities of struts 240, 242 can be connected to each other to form a third row of cells 274.
  • the illustrated frame 230 includes three rows of cells 270, 272, 274, other examples of the frame 230 can include one, two, four, five, six, etc. rows of cells.
  • each cell of the frame 230 has a diamond shape.
  • the struts of the frame 230 can be arranged to form cells with different shapes (for example, circles, triangles, squares, rectangles, pentagons, hexagons, heptagons, octagons, etc.).
  • the frame 230 in its shape set state can include a cylindrical portion formed by the cells 274, a flared region formed by the cells 272 that increases in diameter in a direction extending away from the cells 274, and a tapered region formed by the cells 270 that decreases in diameter in a direction extending away from the cells 272.
  • the cylindrical portion or at least the apices 268 can be fixed to the nose cone 122 or another component of the delivery apparatus.
  • the cylindrical portion or at least the apices 268) can be fixed to the intermediate shaft 106 or another component of the delivery apparatus (for example, the outer shaft 104). In other examples, no cylindrical portion is provided.
  • the distal valve positioning structure 228 can optionally be fixed to the balloon 118 as described elsewhere herein.
  • the frame 230 in its shape set state can include a constant taper or decrease in diameter along its length from one end to the other end.
  • the frame tapers in a distal-to- proximal direction and the smaller diameter end portion (or at least the apices 268) can be fixed to the intermediate shaft 106 or another component of the delivery apparatus (for example, the outer shaft 104).
  • the frame 230 tapers in a proximal-to-distal direction and the smaller diameter end portion (or at least the apices 268) can be fixed to the nose cone 122 or another component of the delivery apparatus.
  • the valve positioning structures 226, 228 can be fixed to nose cone 122 and the intermediate shaft 106, respectively, (or to other components of the delivery apparatus) with an adhesive and/or by reflowing the polymer material forming the nose cone 122 and the intermediate shaft 106 such that the polymer material bonds to or encases an adjacent portion of the valve positioning structures 226, 228.
  • the valve positioning structures 226, 228 are not physically fixed or attached to the balloon 118 to facilitate inflation of the balloon 118.
  • the balloon 118 is folded to form axially extending pleats or folds to minimize the crimp profile of the balloon 118.
  • the balloon 118 can unfold and inflate as an inflation fluid is introduced into the balloon 118.
  • FIGS. 6A and 6B there is shown an expandable, external distal valve positioning structure 326 and an expandable, external proximal valve positioning structure 328, respectively, according to one example.
  • the valve positioning structures 326, 328 can each comprise the frame 230.
  • One exemplary difference between the valve positioning structures 326, 328 and the valve positioning structures 226, 228 shown in FIGS. 5A-5B is that each of the valve positioning structures 326, 328 further comprises a polymeric coating 275 (which is also referred to herein as a “polymeric cover,” a “coating,” and/or a “cover”) disposed on at least one of an inner surface and an outer surface of the frame 230.
  • a polymeric coating 275 which is also referred to herein as a “polymeric cover,” a “coating,” and/or a “cover”
  • the polymeric coating 275 can be formed from any suitable polymer, such any of various synthetic elastomers, such as polyurethane, (for example, TecoflexTM or NueSoftTM), styrene ethylene butylene styrene (SEBS), styrene butadiene styrene (SBS), styrene isoprene styrene (SIS), silicone, silicone-polyurethane blends, or thermoplastic vulcanizate (TPV) (for example, Santoprene).
  • the polymeric coating 275 can provide an atraumatic finish that further minimizes potentially traumatic contact with the tissue of the subject’s vasculature.
  • the polymeric coating 275 can form a liner or layer of material on the inner surface of the frame 230, the outer surface of the frame 230, or both the inner surface and outer surface of the frame 230.
  • the frame 230 is encapsulated within the polymeric coating 275.
  • Various techniques for example, reflow of material extrusions and/or lamination) can be used to form the polymeric coating 275, such as by dipping the frame 230 into the material that forms the polymeric coating 275 when the polymeric coating 275 is in a liquified state.
  • the polymeric coating 275 is only shown with reference to FIGS.
  • any valve positioning structure disclosed herein can include a polymeric coating (on the inner surface and/or the outer surface of the frame of the valve positioning structure) that shares certain similarities with the polymeric coating 275.
  • the polymeric coating 275 can be provided directly on a portion of the outer surface of the balloon 118, and the frame 230 can be omitted. In such embodiments, the polymeric coating 275 can serve as an external valve positioning structure.
  • FIG. 7 A there is shown a distal end portion of a delivery apparatus 200, according to one example.
  • the delivery apparatus 200 includes at least one suture 276 (for example, a plurality of sutures) connected to the distal valve positioning structure 226.
  • the suture 276 (which are also referred to herein as “tethers” and/or “cords”) can extend distally from a proximal end portion of the delivery apparatus 200 (for example, from the handle 102), through the lumen of the intermediate shaft 106, along the outer surface of the balloon 118, and connect to a portion of the distal valve positioning structure 226 (for example, the frame 230 of the distal valve positioning structure 226).
  • the at least one suture 276 can be connected to the frame 230 of the distal valve mounting portion 226 using loops, knots, mechanical fasteners, adhesives, etc.
  • an intermediate portion of the suture 276 can be looped around an apex (for example, one of the proximal apices 268 shown in FIG. 5C) of the frame 230.
  • a distal end of the suture 276 can terminate in a loop 280 that can be secured to a portion of the frame 230 (for example, one of the proximal apices 268 shown in FIG. 5C).
  • a portion of the frame 230 for example, one of the proximal apices 268 shown in FIG. 5C.
  • the at least one suture 276 can be connected to an adjustment member for adjusting tension in the suture 276.
  • the suture 276 can be connected to a rotatable knob coupled to the handle 102 of the delivery apparatus 200. The user can rotate the knob to vary the tension in the suture 276.
  • the distal valve positioning structure 226 reverts to its radially compressed state. Tensioning the sutures 276 can further reduce the diameter of the proximal end of the distal valve positioning structure 226 so that the delivery apparatus 200 can be more easily retracted back through an introducer sheath when being removed from the patient’s body.
  • the at least one suture 276 can be connected to both of the distal valve positioning structure 326 and the proximal valve positioning structure 328.
  • the distal end of the suture 276 can be connected to the distal valve mounting portion 226 and a proximal end of the suture 276 can be connected to the proximal valve positioning structure 328, thereby coupling the distal valve mounting portion 226 and the proximal valve positioning structure 328.
  • the at least one suture 276 can be used to secure the distal valve positioning structure 326 and the proximal valve positioning structure 328 relative to the balloon 118 without fixedly attaching (for example, with fasteners or adhesive) the valve positioning structures 326, 328 to the outer surface of the balloon 118.
  • FIG. 8A there is shown a distal end portion of a delivery apparatus 300, according to another example.
  • the illustrated portion of the delivery apparatus 300 includes the intermediate shaft 106, the nose cone 122 distally disposed relative to the intermediate shaft 106, a balloon (such as balloon 1 18) disposed between the intermediate shaft 106 and the nose cone 122, and the prosthetic valve 150 crimped around the distal end portion of the delivery apparatus 300.
  • a balloon such as balloon 1 18
  • the delivery apparatus 300 includes a single expandable, external valve positioning structure 325 that replaces the function of separate distal and proximal valve structures 226, 228.
  • the valve positioning structure 325 extends along an axial length of the balloon).
  • the valve positioning structure 325 can extend over the entire axial length of the balloon or substantially (within 10%) the entire axial length of the balloon.
  • the valve positioning structure 325 can be disposed around the balloon of the delivery apparatus 300 and/or coupled to an external surface of the balloon. Desirably, the valve positioning structure 325 is not directly physically attached to the balloon to allow the pleats of the balloon to move relative to the valve positioning structure 325 and unfold as the balloon is inflated.
  • the valve positioning structure 325 can be fixed at its distal end to the nose cone 122.
  • the valve positioning structure 325 can be fixed at its proximal end to the distal end portion of the intermediate shaft 106 (for example, an inner surface of the intermediate shaft 106 or an outer surface of the intermediate shaft 106).
  • the prosthetic valve 150 can be mounted or crimped around an intermediate portion of the valve positioning structure 325.
  • the valve positioning structure 325 can include a frame 330 defining a distal valve positioning portion 326, a proximal valve positioning portion 328 disposed proximally relative to the distal valve positioning portion 326, and an intermediate valve positioning portion 329 disposed between the distal valve positioning portion 326 and the proximal valve positioning portion 328.
  • the valve positioning structure 325 can be configured such that the intermediate valve positioning portion 329 aligns in an axial direction of the delivery apparatus 300 with the valve mounting portion 124 and/or the intermediate portion 118b of the balloon 118.
  • the prosthetic valve 150 can be crimped around the intermediate valve positioning portion 329 and between the distal valve positioning portion 326 and the proximal valve positioning portion 328.
  • the intermediate valve positioning portion 329 when the prosthetic valve 150 is crimped around the intermediate valve positioning portion 329, none of the distal valve positioning portion 326, the proximal valve positioning portion 328, or the intermediate valve positioning portion 329 overlap the outer surface of the prosthetic valve 150. Furthermore, in some examples, when the prosthetic valve 150 is crimped around the intermediate valve positioning portion 329, no portion of the prosthetic valve 150 touches the outer surface of the balloon 118. In other words, the intermediate valve positioning portion 329 (as well as all other intermediate valve positioning portions disclosed herein) can prevent contact between the prosthetic valve 150 and the outer surface of the balloon 118.
  • the distal valve positioning portion 326 can have an outer diameter that is greater than an outer diameter of each of the intermediate valve positioning portion 329 and the prosthetic valve 150 in its radially compressed state, as shown in FIG. 8A.
  • the outer profile of the distal valve positioning portion 326 enables the delivery apparatus 300 to be more easily advanced through an introducer sheath and/or a patient’s vasculature in a manner that protects against undesirable contact between the leading edge (the distal end) of the prosthetic valve 150 and the patient’s vasculature and between the leading edge of the prosthetic valve 150 and an inner surface of the introducer sheath.
  • each of the distal valve positioning structure 326 and the proximal valve positioning structure 328 can have an outer diameter that is greater than the outer diameter of each of the intermediate valve positioning portion 329 and the prosthetic valve 150 in its radially compressed state.
  • the distal and proximal valve positioning portions 326, 328 can be configured to counteract distally- and proximally-directed forces applied by the prosthetic valve 150 during delivery of the prosthetic valve 150, thereby maintaining the positioning of the prosthetic valve 150 on the balloon 118 as it is advanced through an introducer sheath and the patient’ s vasculature.
  • the distal valve positioning portion 326, the proximal valve positioning portion 328, and the intermediate valve positioning portion 329 can be connected to form the frame 330, which can comprise a plurality of struts arranged into a plurality of cells.
  • the frame 330 can be a unitary and/or fastener-free structure.
  • the distal valve positioning portion 326, the proximal valve positioning portion 328, and the intermediate valve positioning portion 329 can be formed from a single piece of material (for example, Nitinol), such as in the form of a tube.
  • the valve positioning structure 325 and/or the frame 330 can be formed by removing portions (for example, via laser cutting) of the single piece of material.
  • the frame 330 of the valve positioning structure 325 (and all other frames of valve positioning structures disclosed herein) can be made of a shape memory material, such as Nitinol. When made of such a shape memory material, the frame 330 (and all other frames disclosed here) can be shape set in the radially collapsed state (FIGS. 8A and 8B), and can radially expand to a radially expanded state under the force of the inflating balloon and then radially collapse back to the radially collapsed state under its own resiliency when the balloon is deflated.
  • a shape memory material such as Nitinol
  • valve positioning structure 325 (and other valve positioning structures disclosed herein) is that the frame 330, when made of a metal (such as Ninitol), the frame 330 is visible under fluoroscopy and therefore the frame 330 (or portions thereof) can be used as positioning or alignment device for positioning the prosthetic valve relative to the intended implantation site.
  • the balloon can be inflated with a clear inflation fluid (such as saline) without a contrast solution, which typically is used in valve implantation procedures to make the balloon visible under fluoroscopy.
  • the use of a clear inflation fluid (which in some examples can be less allergenic than contrast solution) to inflate the balloon can further reduce the likelihood of potential complications (for example, allergic reactions to contrast solution) if the balloon bursts or leaks during the implantation process.
  • the single valve positioning structure 325 can be provided in a form other than the frame 330, such as any of the other possible variations disclosed elsewhere herein. This includes, but is not limited to, a polymeric (for example, elastomeric) coating of the balloon 118.
  • FIGS. 9A-9C illustrate a distal end portion of a delivery apparatus 400 during different stages of a prosthetic valve implantation procedure, according to one example.
  • the delivery apparatus 400 can include the intermediate shaft 106, the nose cone 122 disposed distally relative to the intermediate shaft 106, and the balloon 118 (FIGS. 9B-9C) in a deflated state.
  • the delivery apparatus 400 includes an expandable, external valve positioning structure 425.
  • the valve positioning structure 425 can include a distal valve positioning portion 426, a proximal valve positioning portion 428 proximally disposed relative to the distal valve positioning portion 426, and an intermediate valve positioning portion 429 disposed between the distal valve positioning portion 426 and the proximal valve positioning portion 428. As shown, an outer diameter of each of the distal valve positioning portion 426 and the proximal valve positioning portion 428 is larger than an outer diameter of the intermediate valve positioning portion 429 when the valve positioning structure 425 is in a radially collapsed state.
  • the illustrated valve positioning structure 425 comprises a braided mesh structure 430.
  • the braided mesh structure 430 can be formed by braiding one or more wires (for example, Nitinol wires).
  • the braided mesh structure 430 is shape set in a radially collapsed state (FIG. 9A) and is configured to radially expand to a radially expanded state (FIG. 9C) as the balloon is inflated. As the inflation fluid is removed from the balloon, the braided mesh structure 430 can return to the radially collapsed state under its own resiliency.
  • FIG. 9B there is shown the distal end portion of the delivery apparatus 400, wherein the balloon 118, the prosthetic valve 150, and the valve positioning structure 425 are each in a partially radially expanded state (which is also referred to herein as a “partially radially collapsed state” and/or “partially radially compressed state”) between the radially compressed state and the radially expanded state.
  • a partially radially expanded state which is also referred to herein as a “partially radially collapsed state” and/or “partially radially compressed state”
  • the outer diameter of each of the distal valve positioning portion 426 and the proximal valve positioning portion 428 is larger than the outer diameter of the intermediate valve positioning portion 429 when the valve positioning structure 425 is in the partially radially expanded state.
  • valve mounting structure 425 can help keep the prosthetic valve 150 aligned in an axial direction of the delivery apparatus 400 with the valve mounting portion 124 as the balloon 118 is inflated.
  • the prosthetic valve 150 is crimped around the intermediate valve positioning portion 429 and when the balloon 118 is partially radially expanded, none of the distal valve positioning portion 426, the proximal valve positioning portion 428, or the intermediate valve positioning portion 429 overlap the outer surface of the prosthetic valve 150.
  • FIG. 9C there is shown the distal end portion of the delivery apparatus 400, wherein the balloon 118, the prosthetic valve 150, and the valve positioning structure 425 are each in the radially expanded state.
  • the outer diameter of each of the distal valve positioning portion 426 and the proximal valve positioning portion 428 is substantially the same as the outer diameter of the intermediate valve positioning portion 429 when the valve positioning structure 425 is in the radially expanded state.
  • the outer diameter of each of the distal valve positioning portion 426 and the proximal valve positioning portion 428 can be within 10% of the outer diameter of the intermediate valve positioning portion 429 when the valve positioning structure 425 is in the radially expanded state.
  • the prosthetic valve 150 can be uniformly expanded along its axial length by the expansion of the balloon 118 and/or the valve positioning structure 425.
  • the uniform expansion of the balloon 118 and/or the valve positioning structure 425 can help minimize and/or prevent axial migration (for example, distal migration) of the prosthetic valve 150.
  • FIGS. 10A-10E illustrate an expandable, external valve positioning structure 525, according to one example.
  • the valve positioning structure 525 shown in a radially collapsed state — comprises a frame 530 defining a distal valve positioning portion 526, a proximal valve positioning portion 528 proximally disposed relative to the distal valve positioning portion 526, and an intermediate valve positioning portion 529 disposed between the distal valve positioning portion 526 and the proximal valve positioning portion 528.
  • the distal valve positioning portion 526 can have a tapered shape.
  • the distal end portion of the distal valve positioning portion 526 defines a first diameter DI and the proximal end portion of the distal valve positioning portion 526 defines a second diameter D2.
  • D2 can be greater than DI such that the distal valve positioning portion 526 tapers towards the distal end portion of the valve positioning structure 525.
  • the proximal valve positioning portion 528 can have a tapered shape.
  • the distal end portion of the proximal valve positioning portion 528 defines a fourth diameter D4 and the proximal end portion of the proximal valve positioning portion 528 defines a fifth diameter D5.
  • D4 can be greater than D5 such that the proximal valve positioning portion 528 tapers towards the proximal end portion of the valve positioning structure 525.
  • the intermediate valve positioning portion 529 can have a cylindrical shape.
  • the intermediate valve positioning portion 529 can define a third diameter D3 that is constant or a substantially constant (within 10%) along the axial length of the intermediate valve positioning portion 529.
  • the intermediate valve positioning portion 529 can define a third diameter D3 that varies no more than 10% along the axial length of the intermediate valve positioning portion 529.
  • at least one of the region between the distal valve positioning portion 526 and the intermediate valve positioning portion 529 and the region between the proximal valve positioning portion 528 and the intermediate valve positioning portion 529 can be flared.
  • the flared region can define a shoulder (for example, a distal shoulder or a proximal shoulder) of the valve positioning structure 525.
  • the second diameter D2 of the distal valve positioning portion 526 is greater than the third diameter D3 of the intermediate valve positioning portion 529.
  • the fourth diameter D4 of the proximal valve positioning portion 528 is greater than the third diameter D3 of the intermediate valve positioning portion 529.
  • forming a flared region on the valve positioning structure 525 can help further reduce axial movement of an implant (such as the prosthetic valve 10 or the prosthetic valve 150) mounted around the intermediate valve positioning portion 529.
  • the first diameter DI, the third diameter D3, and the fifth diameter D5 can be equal or substantially equal (within 10%).
  • the first diameter DI, the third diameter D3, and the fifth diameter D5 can be within 10% of each other.
  • DI, D3, and D5 can be equal or substantially equal to the outer diameter of a balloon (for example, the balloon 118) in a radially collapsed or deflated state in order to further minimize the outer diameter of the valve positioning structure 525.
  • the third diameter D3 can be greater than each one of the first diameter DI and the second diameter D2.
  • the third diameter D3 can be less than each one of the first diameter DI and the second diameter D2.
  • the third diameter D3 can be greater than each one of the fourth diameter D4 and the fifth diameter D5.
  • the third diameter D3 can be less than each one of the fourth diameter D4 and the fifth diameter D5.
  • each of the distal valve positioning portion 526 and the proximal valve positioning portion 528 comprises the same arrangement of struts and/or cells, such that the frame 530 is axially symmetric about the intermediate valve positioning portion 529.
  • one of the distal valve positioning portion 526 and the proximal valve positioning portion 528 can include a different arrangement of struts and/or cells.
  • the frame 530 can be shape set in the radially collapsed state shown in FIG. 10A to form the valve positioning structure 525.
  • any frame disclosed herein that includes a proximal portion, a distal portion, and an intermediate portion can be shape set in the radially collapsed state to form a valve positioning structure having a similar shape as valve positioning structure 525 shown in FIG. 10A.
  • each of the distal valve positioning portion 526 and the proximal valve positioning portion 528 comprises a plurality of struts that includes a first plurality of struts 532 and a second plurality of struts 534.
  • Each one of the first plurality of struts 532 (which are also referred to herein as a “plurality of angled linear struts,” a “plurality of angled struts,” and/or a “plurality of linear struts”) can have a linear shape and can be oriented at an angle relative to an axial direction of the frame 530.
  • the first plurality of struts 532 can be arranged into one or more rows 570 that extend in a circumferential direction of the frame 530 with the junctions between adjacent ends of the first plurality of struts 532 pointing either in the distal or proximal directions.
  • the first plurality of struts 532 are arranged into four rows 570.
  • the first plurality of struts 532 can be arranged into any other number of rows (for example, one row, two rows, three rows, five rows, six rows, etc.) in other examples of the frame 530.
  • Each one of the second plurality of struts 534 (which are also referred to herein as a “plurality of zig-zag struts,” a “plurality of z-struts,” and/or a “plurality of jagged struts”) can have a zigzag or sawtooth shape.
  • the plurality of second struts 534 be arranged into one or more rows 572 that extends in a circumferential direction of the frame 530 with the peaks formed along each of the plurality of second struts 534 pointing in the circumferential direction.
  • the second plurality of struts 534 are arranged into three rows 572.
  • the second plurality of struts 534 can he arranged into any other number of rows (for example, one row, two rows, four rows, five rows, six rows, etc.) in other examples of the frame 530.
  • rows 570, 572 of the first and second pluralities of struts 532, 534 are arranged in an alternating pattern.
  • the illustrated arrangement of alternating rows 570, 572 can improve the flexibility of the valve positioning structure 525 while providing sufficient axial stiffness to support the balloon 118 and/or the prosthetic valve 150.
  • the first plurality of struts 532 can support the balloon 118 and/or the prosthetic valve 150, while the second plurality of struts 534 can bend when the valve positioning structure 525 is manipulated and subjected to external forces during use.
  • Such an arrangement can better enable the valve positioning structure 525 to be more easily advanced through an introducer sheath and/or a patient’ s vasculature (for example, at or around the aortic arch).
  • the intermediate valve positioning portion 529 can comprise a third plurality of struts 536 (which are also referred to herein as a “plurality of axial linear struts,” a “plurality of connecting struts,” a “plurality of intermediate connecting struts,” and/or a “plurality of intermediate struts”) that connect the distal valve positioning portion 526 and the proximal valve positioning portion 528.
  • the third plurality of struts 536 can help minimize interactions between the frame 530 and a prosthetic heart valve’s leaflets (for example, leaflets 40 of prosthetic heart valve 10 or leaflets of valve 150).
  • Each one of the third plurality of struts 536 can include a distal end and a proximal end. As shown, each one of the third plurality of struts 536 connects at its distal end to a junction of two struts 532 at the distal valve positioning portion 526. As further shown, each one of the third plurality of struts 536 connects at its proximal end to a junction of two of the first plurality of struts 532 at the proximal valve positioning portion 528.
  • the frame 530 can be a unitary and/or fastener-free structure that can be formed from a single piece of material (for example, Nitinol), such as in the form of a tube.
  • the frame 530 can comprise the plurality of struts (for example, pluralities of struts 532, 534, 536) formed into a plurality of cells.
  • the plurality of struts and/or cells can be formed by removing portions (for example, via laser cutting) of the single piece of material.
  • FIG. 10C there is shown the valve positioning structure 525 mounted to a distal end portion of a delivery apparatus 500.
  • the delivery apparatus 500 includes the intermediate shaft 106, the nose cone 122 disposed distally relative to the intermediate shaft 106, and the balloon 118 coupled to the intermediate shaft 106 and/or the nose cone 122.
  • the balloon 118 is shown in the deflated state.
  • the valve positioning structure 525 is mounted around the balloon 118 (for example, to an external surface of the balloon 118).
  • the distal end of the distal valve positioning portion 526 can be fixed to the nose cone 122 and the proximal end of the proximal valve positioning portion 528 can be fixed to the intermediate shaft 106 (for example, an interior or external surface of a distal end of the intermediate shaft 106).
  • the intermediate valve positioning portion 529 is aligned in an axial direction of the delivery apparatus 500 with the valve mounting portion 124 and/or the intermediate portion 118b of the balloon 118.
  • FIG. 10D there is shown the prosthetic valve 150 in its radially compressed state mounted to the distal end portion of the delivery apparatus 500.
  • the prosthetic valve 150 can be mounted and/or crimped around the intermediate valve positioning portion 529 of the valve positioning structure 525 when the balloon 118 is in the deflated state, such that the prosthetic valve 150 is disposed between the distal valve positioning portion 526 and the proximal valve positioning portion 528.
  • none of the distal valve positioning portion 526, the proximal valve positioning portion 528, or the intermediate valve positioning portion 529 overlap the outer surface of the prosthetic valve 150.
  • one or more portions of the valve positioning structure 525 can overlap a portion of the prosthetic valve 150.
  • the intermediate valve positioning portion 529 prevents the prosthetic valve 150 from contacting the balloon 118.
  • the distal valve positioning portion 526 enables the delivery apparatus 100 to be more easily advanced through an introducer sheath and/or a patient’ s vasculature in a manner that protects against undesirable contact between the leading edge (the distal end) of the prosthetic valve 150 and the patient’s vasculature and between the leading edge of the prosthetic valve 150 and an inner surface of the introducer sheath.
  • proximal valve positioning portion 528 can be configured to counteract proximally-directed forces applied by the prosthetic valve 150 during delivery of the valve 150, thereby maintaining the positioning of the prosthetic valve 150 on the balloon 118 as it is advanced through an introducer sheath and the patient’s vasculature.
  • FIG. 10E there is shown the prosthetic valve 150 mounted to the distal end portion of the delivery apparatus 500, wherein, the balloon 118, the prosthetic valve 150, and the valve positioning structure 525 are in radially expanded states.
  • the intermediate valve positioning portion 529 is cylindrical when the valve positioning structure 525 is in the radially expanded state.
  • the distal valve positioning portion 526 tapers from the intermediate valve positioning portion 529 to the nose cone 122 and the proximal valve positioning portion 528 tapers from the intermediate valve positioning portion 529 to the intermediate shaft 106 when the valve positioning structure 525 is in the radially expanded state.
  • Known delivery apparatuses used for delivering balloon-expandable prosthetic valve heart valves typically include balloons with relatively long distal and proximal sections that extend beyond the distal and proximal ends of the prosthetic valve. These distal and proximal balloon sections typically are inflated at a faster rate than the central section of the balloon on which the prosthetic valve is mounted. As a result, the balloon can assume a “dog bone” shape as it is being inflated such that the distal and proximal sections can be inflated to a greater diameter than the prosthetic valve, at least initially.
  • the distal and proximal balloon sections help fix the position of the prosthetic valve on the balloon and minimize shifting of the prosthetic valve relative to the balloon as the balloon is inflated to deploy the prosthetic valve.
  • the relatively long balloon can be make navigating a patient’s vasculature more difficult and may contact portions of the patient’s vasculature (for example, the sinotubular junction (STJ) and/or the left ventricular outflow tract (LVOT)) during a prosthetic valve implantation procedure.
  • STJ sinotubular junction
  • LVOT left ventricular outflow tract
  • the external valve positioning structures disclosed herein can advantageously serve to minimize, reduce, or prevent axial movement of a prosthetic heart valve relative to a balloon of a delivery apparatus.
  • the external valve positioning structures disclosed herein can, in some examples, advantageously reduce the need for a dogbone shaped balloon, thereby allowing for balloons with shorter overall lengths that are easier to navigate through a patient’ s vasculature.
  • the delivery apparatus 600 includes the intermediate shaft 106, the inner shaft 108 extending coaxially through the intermediate shaft 106 to the nose cone 122, and a balloon 218 disposed around the inner shaft 108 and between the intermediate shaft 106 and the nose cone 122.
  • the delivery apparatus 600 also includes an expandable, external valve positioning structure 625. Desirably, although not necessarily, no portion of the valve positioning structure 625 overlaps the outer surface of the prosthetic valve 150.
  • One exemplary difference between the balloon 218 and the previously illustrated balloon 118 is that the balloon 218 has a shorter axial length than the balloon 118.
  • the shorter axial length of the balloon 218 can help the delivery apparatus 600 better navigate the patient’s vasculature to avoid contact with portions of the patient’s vasculature (for example, the sinotubular junction (STJ) and/or the left ventricular outflow tract (LVOT)) during a prosthetic valve implantation procedure.
  • portions of the patient’s vasculature for example, the sinotubular junction (STJ) and/or the left ventricular outflow tract (LVOT)
  • STJ sinotubular junction
  • LVOT left ventricular outflow tract
  • valve positioning structure 625 has a shorter axial length than the valve positioning structure 525.
  • valve positioning structure 625 can have the same overall construction and shape (in the expanded and collapsed states) as the valve positioning structure 525, except that the valve positioning structure 625 is shorter than the valve positioning structure 525.
  • FIG. 12 is a schematic profile view of four exemplary balloons for a delivery apparatus, according to one example. In particular, FIG.
  • the balloon 12 offers a side-by-side comparison of the axial lengths (from the proximal-most end of the balloon to the distal-most end of the balloon) of the balloon 118 (which is also referred to herein as a “first balloon”), the balloon 218 (which is also referred to herein as a “second balloon”), a balloon 318 (which is also referred to herein as a “third balloon”), and a balloon 418 (which is also referred to herein as a “fourth balloon”).
  • each of the second, third, and fourth balloons 218, 318, and 418 can have a length that is equal to or substantially equal (within 10%) to the length of the prosthetic valve in its radially compressed state.
  • the balloon 218, 318, and 418 can be selected based on the size of the prosthetic valve to be implanted.
  • the first balloon 118 can have a first axial length, which can be in a range from 51 mm to 57 mm, such as from 52 mm to 56 mm, from 54 mm to 55 mm, and/or 54.5 mm.
  • the second balloon 218 can have a second axial length, which can be in a range from 45 mm to 51 mm, such as from 46 mm to 50 mm, from 47 mm to 49 mm, 47 mm to 48 mm, and/or 47.3 mm.
  • the third balloon 318 can have a third axial length, which can be in a range from 31 mm to 45 mm, such as from 32 mm to 44 mm, from 33 mm to 43 mm, from 34 mm to 42 mm, from 31 mm to 37 mm, from 32 mm to 36 mm, from 33 mm to 35 mm, and/or 34 mm.
  • the fourth balloon 418 can have a fourth axial length, which can be in a range from 25 mm to 31 mm, such as from 26 mm to 30 mm, from 27 mm to 29 mm, and/or 28 mm.
  • delivery apparatuses that include a valve positioning structure can be compatible with any one of the first balloon 118, the second balloon 218, the third balloon 318, or the fourth balloon 418.
  • a distal end portion of a delivery apparatus that includes both a valve positioning structure and one of the second balloon, 218, third balloon 318, or fourth balloon 418 can be more easily advanced through the patient’s vasculature (for example, in and/or around the sinotubular junction and/or the left ventricular outflow tract) than a distal end portion of a delivery apparatus that includes a relatively axially longer balloon.
  • FIG. 13 there is shown a flattened view of a frame 730 of an expandable, external valve positioning structure, according to one example.
  • the frame 730 can be shape set to form any one of a distal valve positioning structure or a proximal valve positioning structure similar to those shown in FIGS. 5A-5B.
  • the frame 730 can be used to form a valve positioning structure that includes both proximal and distal valve positioning portions interconnected to each other with an intermediate portion, for example, an intermediate portion comprising axial struts 536.
  • the frame 730 can comprise a plurality of struts 732.
  • Each one of the plurality of struts 732 can comprise a first end portion 733 oriented parallel to an axial direction of the frame 730 and a second end portion 735 oriented parallel to the axial direction of the frame 730. As shown, the first end portion 733 is offset in a circumferential direction from the second end portion 735.
  • Each one of the plurality of struts 732 can further comprise an intermediate portion 737 oriented at an angle relative to the axial direction of the frame 730.
  • the cross-sectional width of each one of the plurality of struts 732 can optionally vary along its length.
  • the cross-sectional width of each one of the plurality of struts 732 is wider at the first and second end portions 733, 735 than at the intermediate portion 737 disposed between the first and second end portions 733, 735.
  • the reduced cross-section at the intermediate portion 737 can better allow the plurality of struts 732 to bend or flex, which can beneficially result in a more flexible frame 730 that can be more easily navigated through the patient’s vasculature.
  • Adjacent ones of the plurality of struts 732 can form apices 766 at the axial ends of the frame 730.
  • the apices 766 can be formed by the second end portions 735 of adjacent ones of the plurality of struts 732.
  • each apex 766 can form a circular head 767.
  • the rounded shape of the circular head 767 can make it easier to advance the delivery apparatus.
  • the atraumatic shape of the circular head 767 can further minimize potential damage to the prosthetic valve and/or the balloon when the circular head 767 contacts the prosthetic valve and/or balloon during inflation.
  • adjacent ones of the plurality of struts 732 can connect with three other ones of the plurality of struts 732 at junctions 762 (which are also referred to herein as “unions”).
  • junctions 762 can comprise four of the plurality of struts 732 that connect via a crossbar 763 extending in a circumferential direction of the frame 730 to form an H-shaped arrangement of struts.
  • the frame 730 is symmetric in the axial direction of the frame 730.
  • each axial end of the frame 730 can be either the proximal end of the frame 730 or the distal end of the frame 730.
  • apices 766 can be either the proximal apices or distal apices of the frame 730.
  • the frame 730 can be used to form either a proximal valve positioning structure or a distal valve positioning structure and/or can be invertible.
  • the frame 730 can form a distal valve positioning structure or a proximal valve positioning structure and can be shape set such as shown in either FIG. 5A or FIG. 5B.
  • a valve positioning structure can comprise a first frame 730 forming a proximal portion of the valve positioning structure, a second frame 730 forming a distal portion of the valve positioning structure, and an intermediate portion (for example, a plurality of axial struts 536) interconnecting the first and second frames 730.
  • the valve positioning structure 828 can comprise a frame 830.
  • the frame 830 can be used to form either the proximal valve positioning structure or an expandable, external distal valve positioning structure.
  • the proximal valve positioning structure 828 can comprise the frame 830 having a first stiffness and the distal valve positioning structure can comprise a second, different frame having a second stiffness.
  • the second stiffness can be less than the first stiffness such that the distal valve positioning structure expands and/or collapses first, which can better facilitate retrieval of a distal end portion of a delivery apparatus around which the proximal valve positioning structure 828 is mounted.
  • FIG. 14B there is shown the frame 830 of the proximal valve positioning structure 828, wherein the frame 830 is shown in a flattened configuration.
  • the frame 830 is primarily shown with reference to the proximal valve positioning structure 828, the frame 830 can be used to form a distal valve positioning structure or any other valve positioning structure (for example, a valve positioning structure that includes both proximal and distal valve positioning portions interconnected to each other with an intermediate portion, such as an intermediate portion comprising axial struts 536).
  • the frame 830 can comprise a plurality of struts that includes a first plurality of struts 832, a second plurality of struts 834, a third plurality of struts 836, a fourth plurality of struts 838, a fifth plurality of struts 840, and a sixth plurality of struts 842.
  • the first plurality of struts 832 (which are also referred to herein as a “plurality of axial linear struts,” a “plurality of axial struts,” and/or a “plurality of linear struts”) can be arranged into a first row 844 that extends in a circumferential direction of the frame 830. Each one of the first plurality of struts 832 can be oriented in an axial direction of the frame 830. Each one of the first plurality of struts 832 can comprise a distal end and a proximal end.
  • the distal ends of adjacent ones of the first plurality of struts 832 can be connected at semicircular distal apices 856 that define a distal end of the frame 830.
  • the proximal ends of adjacent ones of the first plurality of struts 832 can be connected at junctions 858 (which are also referred to herein as “unions”).
  • the second plurality of struts 834 (which are also referred to herein as a “plurality of axial linear struts,” a “plurality of axial struts,” and/or a “plurality of linear struts”) can be arranged into a second row 846 that extends in the circumferential direction of the frame 830.
  • Each one of the second plurality of struts 834 can be oriented in the axial direction of the frame 830.
  • Each one of the second plurality of struts 834 can comprise a distal end and a proximal end. The distal ends of adjacent ones of the second plurality of struts 834 can be connected at the junctions 858.
  • Each junction 858 can be formed by connecting the axially- extending proximal ends of two adjacent ones of the second plurality of struts 834 and the axially-extending distal ends of two adjacent ones of the second plurality of struts 834 via a crossbar 863 that extends in the circumferential direction of the frame 830 to form an H- shaped arrangement of struts.
  • the proximal ends of adjacent ones of the first plurality of struts 832 can be connected at junctions 860 (which are also referred to herein as “unions”).
  • the third plurality of struts 836 (which are also referred to herein as a “plurality of axial linear struts,” a “plurality of axial struts,” and/or a “plurality of linear struts”) can be arranged into a third row 848 that extends in the circumferential direction of the frame 830.
  • Each one of the third plurality of stmts 836 can be oriented in the axial direction of the frame 830.
  • Each one of the third plurality of stmts 836 can comprise a distal end and a proximal end. The distal ends of adjacent ones of the third plurality of stmts 836 can be connected at junctions 860.
  • each junction 862 can include four stmts (for example, two adjacent ones of the third plurality of stmts 836 and two adjacent ones of the fourth plurality of stmts 838) connected by the crossbar 863 to form the H-shaped arrangement of stmts.
  • the fourth plurality of stmts 838 (which are also referred to herein as a “plurality of axial linear stmts,” a “plurality of axial stmts,” and/or a “plurality of linear stmts”) can be arranged into a fourth row 850 that extends in the circumferential direction of the frame 830.
  • Each one of the fourth plurality of stmts 838 can be oriented in the axial direction of the frame 830.
  • Each one of the fourth plurality of stmts 838 can comprise a distal end and a proximal end.
  • the distal ends of adjacent ones of the fourth plurality of struts 838 can be connected at junctions 862.
  • the proximal ends of adjacent ones of the fourth plurality of stmts 838 can be connected at junctions 864 (which are also referred to herein as “unions”).
  • the fifth plurality of stmts 840 (which are also referred to herein as a “plurality of axial linear stmts,” a “plurality of axial stmts,” and/or a “plurality of linear stmts”) can be arranged into a fifth row 852 that extends in the circumferential direction of the frame 830.
  • Each one of the fifth plurality of stmts 840 can be oriented in the axial direction of the frame 830.
  • Each one of the fifth plurality of stmts 840 can comprise a distal end and a proximal end.
  • the distal ends of adjacent ones of the fifth plurality of stmts 840 can be connected at junctions 864.
  • the proximal ends of adjacent ones of the fifth plurality of struts 840 can be connected at junctions 866 (which are also referred to herein as “unions”).
  • each junction 866 can include four stmts (for example, two adjacent ones of the fifth plurality of stmts 840 and two adjacent ones of the sixth plurality of stmts 842) connected by the crossbar 863 to form the H-shaped arrangement of stmts.
  • the sixth plurality of struts 842 (which are also referred to herein as a “plurality of axial linear struts,” a “plurality of axial struts,” and/or a “plurality of linear struts”) can be arranged into a sixth row 854 that extends in the circumferential direction of the frame 830.
  • Each one of the sixth plurality of struts 842 can be oriented in the axial direction of the frame 830.
  • Each one of the sixth plurality of struts 842 can comprise a distal end and a proximal end.
  • the proximal ends of adjacent ones of the sixth plurality of struts 842 can be connected at semicircular proximal apices 868 that define a proximal end of the frame 830.
  • the distal ends of adj cent ones of the sixth plurality of struts 842 can be connected at junctions 866.
  • the struts of the frame 830 can be arranged and/or connected to form a plurality of cells.
  • first and second pluralities of struts 832, 834 can connect to each other to form a first circumferentially-extending row of cells 870.
  • the third and fourth pluralities of struts 836, 838 can be connected to each other to form a second row of cells 872.
  • the fifth and six pluralities of struts 840, 842 can be connected to each other to form a third row of cells 874.
  • the illustrated frame 830 includes three rows of cells 870, 872, 874, other examples of the frame 830 can include one, two, four, five, six, etc. rows of cells.
  • each cell of the frame 830 has a “stadium” or “capsule” shape that includes two parallel sides defining the circumferential ends of each cell and two semicircular (or otherwise rounded) ends defining the axial ends of each cell.
  • the struts of the frame 830 can be arranged to form cells with different shapes (for example, circles, triangles, diamonds, squares, rectangles, pentagons, hexagons, heptagons, octagons, etc.).
  • a frame 930 in a flattened configuration for a valve positioning structure can be formed into either one of a proximal valve positioning structure or a distal valve positioning structure, and optionally can be shape set as shown in either FIG. 5A or FIG. 5B.
  • a valve positioning structure can comprise a first frame 930 forming a proximal portion of the valve positioning structure, a second frame 930 forming a distal portion of the valve positioning structure, and an intermediate portion (for example, a plurality of axial struts 536) interconnecting the first and second frames.
  • the intermediate portion can have a similar or the same structure as the frame 930.
  • the frame 930 can share certain similarities with the frame 230 that is best illustrated in FIG. 5C.
  • One exemplary difference between the frame 930 and the frame 230 is that the frame 930 includes a fourth row of cells 982 at a distal end of the frame 930.
  • Each cell 982 can comprise a box-shaped head 986 and a connecting strut 984 extending between the box- shaped head 986 and a corresponding distal apex 256.
  • fabric, cloth, foam, and/or any padding can be coupled to any of the box-shaped heads 986, such as by stitching the fabric, cloth, foam or padding to the heads 986 with sutures.
  • the fabric, cloth, foam, or padding can cover the heads 986.
  • the heads 986 and the attached fabric, cloth, foam and/or padding can form a distal tip portion (similar to tip portion 128) that can help position the prosthetic heart valve 150 on the balloon 118 in an off-balloon delivery procedure, similar to that shown in FIG. 2B.
  • the fourth row of cells 982 can be disposed closest to the prosthetic valve 150 when the frame 930 is formed into a proximal valve positioning structure and coupled to a delivery apparatus.
  • the resulting valve positioning structure can be configured such that the fourth row of cells 982 (in particular, the box-shaped heads 986 of the fourth row of cells 982) beneficially form a more continuous surface to contact a proximal end of the prosthetic valve 150.
  • the frame 930 can be inverted such that the fourth row of cells 982 is at a proximal end of the frame 930.
  • the resulting valve positioning structure can be configured such that the fourth row of cells 982 (in particular, the box-shaped heads 986 of the fourth row of cells 982) beneficially form a more continuous surface to contact a distal end of the prosthetic valve 150.
  • the heads 986 can have a different shape, such as a circular, oval, or otherwise curved shape.
  • the heads 986 can be triangular or polygonal (for example forming a pentagon or a hexagon).
  • Any other valve positioning structure disclosed herein can include a distal end portion configured to push against the prosthetic heart valve 150 on the balloon 118 in an off-balloon delivery procedure.
  • any valve positioning structure disclosed herein can optionally include the heads 986.
  • FIG. 16 is a flattened view of a frame 1030 of a valve positioning structure, according to one example.
  • a valve positioning structure of a delivery apparatus can be formed at least in part by shape setting the frame 1030 in a radially compressed state (for example, in the shape of the valve positioning structure 525 shown in FIG. 10A).
  • the frame 1030 comprises a distal valve positioning portion 1026, a proximal valve positioning portion 1028, and an intermediate valve positioning portion 1029 disposed therebetween.
  • the distal valve positioning portion 1026 can include a plurality of struts that includes a first plurality of struts 1082 and a second plurality of struts 1084.
  • the first plurality of struts 1082 (which are also referred to herein as a “plurality of angled linear struts,” a “plurality of angled struts,” and/or a “plurality of linear struts”) can be arranged into a first row 1092 that extends in a circumferential direction of the frame 1030.
  • Each one of the first plurality of struts 1082 can be oriented at an angle relative to an axial direction of the frame 1030.
  • Each one of the first plurality of struts 1082 can comprise a distal end and a proximal end.
  • the distal ends of adjacent ones of the first plurality of struts 1032 can be connected at curved or rounded distal apices 1083d that define a distal end of the distal valve positioning portion 1026 and/or the frame 1030.
  • the proximal ends of adjacent ones of the first plurality of struts 1082 can be connected at curved or rounded apices 1083p.
  • the second plurality of struts 1084 (which are also referred to herein as a “plurality of angled linear struts,” a “plurality of angled struts,” and/or a “plurality of linear struts”) can be arranged into a second row 1094 that extends in the circumferential direction of the frame 1030.
  • the second row 1094 can be proximally disposed relative to the first row 1092.
  • Each one of the second plurality of struts 1084 can be oriented at an angle relative to the axial direction of the frame 1030.
  • Each one of the second plurality of struts 1084 can comprise a distal end and a proximal end.
  • the distal ends of adjacent ones of the second plurality of struts 1084 can be connected at curved or rounded apices 1085d.
  • the proximal ends of adjacent ones of the second plurality of struts 1084 can be connected at curved or rounded proximal apices 1085p that define a proximal end of the distal valve positioning portion 1026.
  • the distal valve positioning portion 1026 can further include a plurality of connecting struts 1063 (which are also referred to herein as a “plurality of axial linear connecting struts,” a “plurality of axial connecting struts,” and/or a “plurality of linear connecting struts”).
  • Each one of the plurality of connecting struts 1063 can extend in an axial direction of the frame 1030 from one of the distal apices 1083d to an axially adjacent one of apices 1085p.
  • the plurality of connecting struts 1063 connect every third distal apex 1083d and apex 1085p in the circumferential direction.
  • the plurality of connecting struts 1063 can be arranged to connect any number of apices 1083d, 1085p.
  • the distal valve positioning portion 1026 can be longer in an axial direction than the proximal valve positioning portion 1028.
  • the proximal valve positioning portion 1028 can comprise a plurality of struts that includes a first plurality of struts 1032, a second plurality of struts 1034, a third plurality of struts 1036, a fourth plurality of struts 1038, a fifth plurality of struts 1040, and a sixth plurality of struts 1042.
  • the first plurality of struts 1032 (which are also referred to herein as a “plurality of angled linear struts,” a “plurality of angled struts,” and/or a “plurality of linear struts”) can be arranged into a first row 1044 that extends in the circumferential direction of the frame 1030.
  • Each one of the first plurality of struts 1032 can be oriented at an angle relative to the axial direction of the frame 1030.
  • Each one of the first plurality of struts 1032 can comprise a distal end and a proximal end.
  • the distal ends of adjacent ones of the first plurality of struts 1032 can be connected at curved or rounded distal apices 256 that define a distal end of the proximal valve positioning portion 1028.
  • the proximal ends of adjacent ones of the first plurality of struts 1032 can be connected at junctions 1058 (which are also referred to herein as “unions”).
  • the second plurality of struts 1034 (which are also referred to herein as a “plurality of angled linear struts,” a “plurality of angled struts,” and/or a “plurality of linear struts”) can be arranged in a second row 1046 that extends in the circumferential direction of the frame 1030 and is proximally disposed relative to the first row 1044. Each one of the second plurality of struts 1034 can be oriented at an angle relative to the axial direction of the frame 1030. Each one of the second plurality of struts 1034 can comprise a distal end and a proximal end.
  • junctions 1058 The distal ends of adjacent ones of the second plurality of struts 1034 can be connected at the junctions 1058.
  • junctions 1060 which are also referred to herein as “unions”.
  • the third plurality of struts 1036 (which are also referred to herein as a “plurality of angled linear struts,” a “plurality of angled struts,” and/or a “plurality of linear struts”) can be arranged in a third row 1048 that extends in the circumferential direction of the frame 1030 and is proximally disposed relative to the second row 1046.
  • Each one of the third plurality of struts 1036 can be oriented at an angle relative to the axial direction of the frame 1030.
  • Each one of the third plurality of struts 1036 can comprise a distal end and a proximal end.
  • junctions 1060 The distal ends of adjacent ones of the third plurality of struts 1036 can be connected at junctions 1060.
  • junctions 1062 which are also referred to herein as “unions”.
  • the fourth plurality of struts 1038 (which are also referred to herein as a “plurality of angled linear struts,” a “plurality of angled struts,” and/or a “plurality of linear struts”) can be arranged in a fourth row 1050 that extends in the circumferential direction of the frame 1030 and is proximally disposed relative to the third row 1048.
  • Each one of the fourth plurality of struts 1038 can be oriented at an angle relative to the axial direction of the frame 1030.
  • Each one of the fourth plurality of struts 1038 can comprise a distal end and a proximal end.
  • junctions 1062 The distal ends of adjacent ones of the fourth plurality of struts 1038 can be connected at junctions 1062.
  • junctions 1064 which are also referred to herein as “unions”.
  • the fifth plurality of struts 1040 (which are also referred to herein as a “plurality of angled linear struts,” a “plurality of angled struts,” and/or a “plurality of linear struts”) can be arranged in a fifth row 1052 that extends in the circumferential direction of the frame 1030 and is proximally disposed relative to the fourth row 1050.
  • Each one of the fifth plurality of struts 1040 can be oriented at an angle relative to the axial direction of the frame 1030.
  • Each one of the fifth plurality of struts 1040 can comprise a distal end and a proximal end.
  • junctions 1064 The distal ends of adjacent ones of the fifth plurality of struts 1040 can be connected at junctions 1064.
  • junctions 1066 which are also referred to herein as “unions”.
  • the sixth plurality of struts 1042 (which are also referred to herein as a “plurality of angled linear struts,” a “plurality of angled struts,” and/or a “plurality of linear struts”) can be arranged in a sixth row 1054 that extends in the circumferential direction of the frame 1030 and is proximally disposed relative to the fifth row 1052.
  • Each one of the sixth plurality of struts 1042 can be oriented at an angle relative to the axial direction of the frame 1030.
  • Each one of the sixth plurality of struts 1042 can comprise a distal end and a proximal end.
  • the distal ends of adjacent ones of the sixth plurality of struts 1042 can be connected at junctions 1066.
  • the proximal ends of adjacent ones of the fifth plurality of struts 1040 can be connected at curved or rounded proximal apices 1068 that define a proximal end of the proximal valve mounting portion 1028 and/or the frame 1030.
  • the struts of the proximal valve mounting portion 1028 can be arranged and/or connected to form a plurality of cells.
  • the first and second pluralities of struts 1032, 1034 can connect to each other to form a first circumferentially-extending row of cells 1070.
  • the third and fourth pluralities of struts 1036, 1038 can be connected to each other to form a second row of cells 1072.
  • the fifth and six pluralities of struts 1040, 1042 can be connected to each other to form a third row of cells 1074.
  • the illustrated proximal valve mounting portion 1028 includes three rows of cells 1070, 1072, 1074, other examples of the proximal valve mounting portion 1028 can include one, two, four, five, six, etc. rows of cells.
  • each cell of the proximal valve mounting portion 1028 has a diamond shape.
  • the struts of the proximal valve mounting portion 1028 can be arranged to form cells with different shapes (for example, circles, triangles, other parallelograms, pentagons, hexagons, heptagons, octagons, etc.).
  • the intermediate valve positioning portion 1029 can comprise a plurality of axially- extending intermediate connecting struts 1065 (which are also referred to herein as “intermediate struts”). As shown, each one of the plurality of axially-extending intermediate connecting struts 1065 connects a proximal apex 1085p of the distal valve positioning portion 1026 to a corresponding distal apex 1056 of the proximal valve positioning portion 1028.
  • each of the axially-extending intermediate connecting struts 1065 can connect to the distal and proximal valve positioning portions 1026, 1028 at different locations, including at distal apices at the distal valve positioning portion 1026 and/or at proximal apices at the proximal valve positioning portion 1028.
  • the presence of the plurality of axially-extending intermediate connecting struts 1065 is not dependent on a specific type of distal and/or proximal valve positioning portion.
  • FIG. 17 is a flattened view of a frame 1130 of a valve positioning structure, according to one example.
  • a valve positioning structure of a delivery apparatus can be formed at least in part by shape setting the frame 1130 in a radially compressed state (for example, the state of the valve positioning structure 525 shown in FIG. 10A).
  • the frame 1130 can include a plurality of struts 1132 (which are also referred to herein as a “plurality of angled linear struts,” a “plurality of angled struts,” and/or a “plurality of linear struts”).
  • the plurality of struts 1032 can be arranged into one or more rows 1144 that extends in a circumferential direction of the frame 1130.
  • the plurality of struts 1132 can be arranged into a serpentine pattern that extends in the circumferential direction. Each one of the plurality of struts 1132 can be oriented at an angle relative to an axial direction of the frame 1130. Each one of the plurality of struts 1132 can comprise a distal end and a proximal end. The distal ends of adjacent ones of the plurality of struts 1132 can be connected at curved or rounded apices 1156. The proximal ends of adjacent ones of the plurality of struts 1132 can be connected at curved or rounded apices 1158.
  • the frame 1130 can also include a plurality of connecting struts 1163 (which are also referred to herein as a “plurality of axial linear connecting stmts,” a “plurality of axial connecting stmts,” and/or a “plurality of linear connecting stmts”).
  • Each one of the plurality of connecting stmts 1163 can extend in the axial direction of the frame 1130.
  • Each one of the plurality of connecting stmts 1163 can connect one of the apices 1156 with an axially adjacent one of the apices 1158.
  • each one of the plurality of connecting stmts 1163 connects every fifth apex 1156 with a corresponding apex 1158 in the circumferential direction.
  • the plurality of connecting stmts 1163 can be arranged to connect any number of apices 1156, 1158.
  • the frame 1130 comprises a distal valve positioning portion 1126, a proximal valve positioning portion 1128, and an intermediate valve positioning portion 1129 disposed therebetween.
  • a portion of the frame 1130 (for example, the distal valve positioning portion 1126 or the proximal valve positioning portion 1128) can be shape set to form a distal valve positioning stmcture or a proximal valve positioning stmcture similar to those shown in FIGS. 5A-5C.
  • the distal valve positioning portion 1126 can be axially longer than the proximal valve positioning portion 1128.
  • the intermediate valve positioning portion 1129 can be formed by one or more axially-extending intermediate connecting struts, such as the axially-extending intermediate connecting stmts 1065 depicted in other figures. In some examples, only one of the distal valve positioning portion 1126 and the proximal valve positioning portion 1128 can be formed with the depicted pattern, while the respective other positioning portion can exhibit a different pattern of struts, for example, such as described elsewhere herein.
  • FIG. 18 is a flattened view of a frame 1230 of a valve positioning stmcture, according to one example.
  • a valve positioning stmcture of a delivery apparatus can be formed at least in part by shape setting the frame 1230 in a radially compressed state (for example, the state of the valve positioning stmcture 525 shown in FIG. 10A).
  • the frame 1230 can comprise a distal valve positioning portion 1226, the proximal valve positioning portion 1028 proximally disposed relative to the distal valve positioning portion 1226, and the intermediate valve positioning portion 1029 disposed between the distal valve positioning portion 1226 and the proximal valve positioning portion 1028.
  • the distal valve positioning portion 1226 can be axially longer than the proximal valve positioning portion 1228.
  • the distal valve positioning portion 1226 can include a plurality of struts that includes a first plurality of struts 1232, a second plurality of struts 1234, a third plurality of struts 1236, a fourth plurality of struts 1238, and a fifth plurality of struts 1240.
  • the first plurality of struts 1232 (which are also referred to herein as a “plurality of angled linear struts,” a “plurality of angled struts,” and/or a “plurality of linear struts”) can be arranged into a first row 1244 that extends in a circumferential direction of the frame 1230.
  • Each one of the first plurality of struts 1232 can be oriented at an angle relative to an axial direction of the frame 1230.
  • Each one of the first plurality of struts 1232 can comprise a distal end and a proximal end.
  • the distal ends of adjacent ones of the first plurality of struts 1232 can be connected at curved or rounded distal apices 1283d that define a distal end of the distal valve positioning portion 1226 and/or the frame 1230.
  • the proximal ends of adjacent ones of the first plurality of struts 1082 can be connected at curved or rounded apices 1283p.
  • the second plurality of struts 1234 (which are also referred to herein as a “plurality of angled linear struts,” a “plurality of angled struts,” and/or a “plurality of linear struts”) can be arranged into a second row 1246 that extends in the circumferential direction of the frame 1230.
  • Each one of the second plurality of struts 1234 can be oriented at an angle relative to the axial direction of the frame 1230.
  • Each one of the second plurality of struts 1234 can comprise a distal end and a proximal end.
  • the distal ends of adjacent ones of the second plurality of struts 1234 can be connected at curved or rounded apices 1285d.
  • the proximal ends of adj cent ones of the second plurality of struts 1234 can be connected at curved or rounded apices 1285p.
  • the third plurality of struts 1236 (which are also referred to herein as a “plurality of angled linear struts,” a “plurality of angled struts,” and/or a “plurality of linear struts”) can be arranged into a third row 1248 that extends in the circumferential direction of the frame 1230.
  • Each one of the third plurality of struts 1236 can be oriented at an angle relative to the axial direction of the frame 1230.
  • Each one of the third plurality of struts 1236 can comprise a distal end and a proximal end.
  • the distal ends of adjacent ones of the third plurality of struts 1236 can be connected at curved or rounded apices 1287d.
  • the proximal ends of adjacent ones of the third plurality of struts 1236 can be connected at curved or rounded apices 1287p.
  • the fourth plurality of struts 1238 (which are also referred to herein as a “plurality of angled linear struts,” a “plurality of angled struts,” and/or a “plurality of linear struts”) can be arranged into a fourth row 1250 that extends in the circumferential direction of the frame 1230.
  • Each one of the fourth plurality of struts 1238 can be oriented at an angle relative to the axial direction of the frame 1230.
  • Each one of the fourth plurality of struts 1238 can comprise a distal end and a proximal end.
  • the distal ends of adjacent ones of the fourth plurality of struts 1238 can be connected at curved or rounded apices 1289d.
  • the proximal ends of adjacent ones of the fourth plurality of struts 1238 can be connected at curved or rounded apices 1289p.
  • the fifth plurality of struts 1240 (which are also referred to herein as a “plurality of angled linear struts,” a “plurality of angled struts,” and/or a “plurality of linear struts”) can be arranged into a fifth row 1252 that extends in the circumferential direction of the frame 1230.
  • Each one of the fifth plurality of struts 1240 can be oriented at an angle relative to the axial direction of the frame 1230.
  • Each one of the fifth plurality of struts 1240 can comprise a distal end and a proximal end.
  • the distal ends of adjacent ones of the fifth plurality of struts 1240 can be connected at curved or rounded apices 1291d.
  • the proximal ends of adjacent ones of the fifth plurality of struts 1240 can be connected at curved or rounded proximal apices 1291p, which can constitute a proximal end of the distal valve positioning portion 1226.
  • the distal valve positioning portion 1226 can further include a plurality of connecting struts 1263 (which are also referred to herein as a “plurality of axial linear connecting struts,” a “plurality of axial connecting struts,” and/or a “plurality of linear connecting struts”).
  • Each one of the plurality of connecting struts 1263 can extend in an axial direction of the frame 1230 to connect apices of the frame 1230.
  • connecting struts 1263 can extend between and connect apices 1283p, 1285p, apices 1285p, 1287p, apices 1287p, 1289p, and apices 1289p, 1291p.
  • each one of the plurality of connecting struts 1065 of the intermediate valve positioning portion 1029 connects each one of the proximal apices 129 Ip of the distal valve positioning portion 1226 with an axially adjacent one of the distal apices 1056 of the proximal valve positioning portion 1028.
  • only one of the distal valve positioning portion 1226 and the proximal valve positioning portion 1228 is formed with the depicted pattern of struts, while the respective other positioning portion can exhibit a different pattern of struts, for example, such as described elsewhere herein.
  • the intermediate valve positioning portion 1029 can be formed with a different pattern of struts than the depicted pattern of axially extending connecting struts 1065, for example, with any of the patterns described herein in conjunction with a distal or proximal valve positioning portion.
  • FIG. 19 is a flattened view of a frame 1330 of a valve positioning structure, according to one example.
  • a valve positioning structure of a delivery apparatus can be formed at least in part by shape setting the frame 1330 in a radially compressed state (for example, in the shape of the valve positioning structure 525 shown in FIG. 10A).
  • the frame 1330 can comprise a distal valve positioning portion 1326, the proximal valve positioning portion 1028 proximally disposed relative to the distal valve positioning portion 1326, and the intermediate valve positioning portion 1029 disposed between the distal valve positioning portion 1326 and the proximal valve positioning portion 1028.
  • the distal valve positioning portion 1326 can be axially longer than the proximal valve positioning portion 1328.
  • the distal valve positioning portion 1326 can include a plurality of struts that includes a first plurality of struts 1332, a second plurality of struts 1 34, a third plurality of struts 1336, a fourth plurality of struts 1338, and a fifth plurality of struts 1340.
  • the first plurality of struts 1332 (which are also referred to herein as a “plurality of axial linear struts,” a “plurality of axial struts,” and/or a “plurality of linear struts”) can be arranged into a first row 1344 that extends in a circumferential direction of the frame 1330.
  • Each one of the first plurality of struts 1332 can be oriented in an axial direction of the frame 1330.
  • Each one of the first plurality of struts 1332 can comprise a distal end and a proximal end.
  • the distal ends of adjacent ones of the first plurality of struts 1332 can be connected at curved, rounded, or semicircular distal apices 1383d that define a distal end of the distal valve positioning portion 1326 and/or the frame 1 30.
  • the proximal ends of adjacent ones of the first plurality of struts 1332 can be connected at curved or rounded apices 1383p.
  • the second plurality of struts 1334 (which are also referred to herein as a “plurality of axial linear struts,” a “plurality of axial struts,” and/or a “plurality of linear struts”) can be arranged into a second row 1346 that extends in the circumferential direction of the frame 1330.
  • Each one of the second plurality of struts 1334 can be oriented in the axial direction of the frame 1330.
  • Each one of the second plurality of struts 1334 can comprise a distal end and a proximal end.
  • the distal ends of adjacent ones of the second plurality of struts 1334 can be connected at curved, rounded, or semicircular apices 1385d.
  • the proximal ends of adjacent ones of the second plurality of struts 1334 can be connected at curved, rounded, or semicircular apices 1385p.
  • the third plurality of struts 1336 (which are also referred to herein as a “plurality of axial linear struts,” a “plurality of axial struts,” and/or a “plurality of linear struts”) can be arranged into a third row 1348 that extends in the circumferential direction of the frame 1330.
  • Each one of the third plurality of struts 1336 can be oriented in the axial direction of the frame 1330.
  • Each one of the third plurality of struts 1336 can comprise a distal end and a proximal end.
  • the distal ends of adjacent ones of the third plurality of struts 1336 can be connected at curved, rounded, or semicircular 1387d.
  • the proximal ends of adjacent ones of the third plurality of struts 1336 can be connected at curved, rounded, or semicircular apices 1387p.
  • the fourth plurality of struts 1338 (which are also referred to herein as a “plurality of axial linear struts,” a “plurality of axial struts,” and/or a “plurality of linear struts”) can be arranged into a fourth row 1350 that extends in the circumferential direction of the frame 1330.
  • Each one of the fourth plurality of struts 1338 can be oriented in the axial direction of the frame 1330.
  • Each one of the fourth plurality of struts 1338 can comprise a distal end and a proximal end.
  • the distal ends of adjacent ones of the fourth plurality of struts 1338 can be connected at curved, rounded, or semicircular apices 1389d.
  • the proximal ends of adjacent ones of the fourth plurality of struts 1338 can be connected at curved, rounded, or semicircular apices 1389p.
  • the fifth plurality of struts 1340 (which are also referred to herein as a “plurality of axial linear struts,” a “plurality of axial struts,” and/or a “plurality of linear struts”) can be arranged into a fifth row 1352 that extends in the circumferential direction of the frame 1330.
  • Each one of the fifth plurality of struts 1340 can be oriented in the axial direction of the frame 1330.
  • Each one of the fifth plurality of struts 1340 can comprise a distal end and a proximal end.
  • the distal ends of adjacent ones of the fifth plurality of struts 1340 can be connected at curved, rounded, or semicircular apices 139 Id.
  • the proximal ends of adjacent ones of the fifth plurality of struts 1340 can be connected at curved, rounded, or semicircular proximal apices 1391p, which can constitute a proximal end of the distal valve positioning portion 1326.
  • the distal valve positioning portion 1326 can further include a plurality of connecting struts 1363 (which are also referred to herein as a “plurality of axial linear connecting struts,” a “plurality of axial connecting struts,” and/or a “plurality of linear connecting struts”).
  • Each one of the plurality of connecting struts 1363 can extend in an axial direction of the frame 1330 to connect apices of the frame 1330.
  • connecting struts 1363 can extend between and connect apices 1383p, 1385p, apices 1385p, 1387p, apices 1387p, 1389p, and apices 1389p, 139 Ip.
  • each one of the plurality of connecting struts 1065 of the intermediate valve positioning portion 1029 connects each one of the proximal apices 139 Ip of the distal valve positioning portion 1326 with an axially adjacent one of the distal apices 1056 of the proximal valve positioning portion 1028.
  • only one of the distal valve positioning portion 1326 and the proximal valve positioning portion 1328 is formed with the depicted pattern of struts, while the respective other positioning portion can exhibit a different pattern of struts, for example, such as described elsewhere herein.
  • the intermediate valve positioning portion 1029 can be formed with a different pattern of struts than the depicted pattern of axially extending connecting struts 1065, for example, with any of the patterns described herein in conjunction with a distal or proximal valve positioning portion.
  • FIG. 20A is a side view of a distal end portion of a delivery apparatus 1400, according to one example.
  • the delivery apparatus 1400 includes the intermediate shaft 106, the inner shaft 108, the balloon 118, and the nose cone 122. As shown, the balloon 118 is shown in a deflated state.
  • the delivery apparatus 1400 includes a valve positioning structure 1425 disposed around the balloon 118.
  • the valve positioning structure 1425 includes a frame 1430, which is further described with respect to FIG. 20C.
  • the valve positioning structure 1425 is shown in a radially collapsed state.
  • FIG. 20B is a side view of the distal end portion of the delivery apparatus 1400, wherein the balloon 118 is in an inflated state and the valve positioning structure 1425 is in a radially expanded state.
  • FIG. 20C is a flattened view of the frame 1430 of the valve positioning structure 1425, according to one example.
  • the valve positioning structure 1425 of the delivery apparatus 1400 can be formed at least in part by shape setting the frame 1430 in the radially collapsed state.
  • the frame 1430 can comprise a distal valve positioning portion 1426, the proximal valve positioning portion 1028 proximally disposed relative to the distal valve positioning portion 1426, and the intermediate valve positioning portion 1029 disposed between the distal valve positioning portion 1426 and the proximal valve positioning portion 1028.
  • the distal valve positioning portion 1426 can be axially longer than the proximal valve positioning portion 1428.
  • the distal valve positioning portion 1426 can share certain similarities with the distal valve positioning structure 1326 illustrated in FIG. 19.
  • One exemplary difference between the distal valve positioning portion 1426 and the distal valve positioning structure 1326 is that the distal valve positioning portion 1426 includes a plurality of serpentine connecting struts 1463 (which are also referred to herein as a “plurality of connecting struts” and/or a “plurality of connecting s-struts”) instead of the plurality of linear connecting struts 1363.
  • each one of the plurality of serpentine connecting struts 1463 can include at least one semicircular turn, such as two semicircular turns as shown.
  • the plurality of serpentine connecting struts 1463 can extend in an axial direction of the frame 1430 to connect apices of the frame 1430.
  • the serpentine connecting struts 1463 can extend between and connect apices 1383p, 1385p, apices 1385p, 1387p, apices 1387p, 1389p, and apices 1389p, 1391p.
  • FIG. 21 is a flattened view of a frame 1530 of a valve positioning structure, according to one example.
  • a valve positioning structure of a delivery apparatus can be formed at least in part by shape setting the frame 1530 in a radially compressed state.
  • the frame 1530 can be formed into either one of a proximal valve positioning structure or a distal valve positioning structure, and optionally can be shape set in the radially collapsed state similar to the valve positioning structures shown in FIG. 5 A and FIG. 5B.
  • a valve positioning structure can comprise a first frame 1530 forming a proximal portion of the valve positioning structure, a second frame 1530 forming a distal portion of the valve positioning structure, and an intermediate portion (for example, a plurality of axial struts 536) interconnecting the first and second frames.
  • the distal portion of the valve positioning structure can be axially longer than the proximal portion of the valve positioning structure.
  • Each one of the first plurality of struts 1532 can be oriented at an angle relative to an axial direction of the frame 1530.
  • Each one of the first plurality of struts 1532 can comprise a distal end and a proximal end.
  • the distal ends of adjacent ones of the first plurality of struts 1532 can be connected at apices 1583d.
  • the proximal ends of adjacent ones of the first plurality of struts 1532 can be connected at curved or rounded apices 1583p.
  • the plurality of struts 1532 can be configured to provide the frame 1530 with structural stiffness and also aid in circumferential expansion of the frame 1530.
  • the second plurality of struts 1534 can be arranged into rows 1546, 1550, 1554 that each extend in the circumferential direction of the frame 1530.
  • Each one of the second plurality of struts 1534 can be a strut that forms one or more semicircular turns or curves.
  • each one of the second plurality of struts 1534 forms four semicircular turns.
  • Each one of the second plurality of struts 1534 can comprise a distal end and a proximal end. The distal end of each one of the second plurality of struts 1534 can be connected to a corresponding one of apices 1583d.
  • each one of the second plurality of struts 1534 can be connected to a corresponding one of apices 1583p.
  • rows 1544, 1548, 1552, 1556 of the first plurality of struts 1532 and rows 1546, 1550, 1554 of the second plurality of struts 1534 alternate in the axial direction of the frame 1530.
  • alternating rows of the first plurality of struts 1532 and rows of the second plurality of struts 1534 can provide the frame 1530 with desirable mechanical properties.
  • the first plurality of struts 1532 can imbue structural support and/or stiffness to the frame 1530 while the second plurality of struts 1534 (which can more easily elongate in the axial direction than the first plurality of struts 1532) can better allow the frame 1530 to flex and/or elongate.
  • the first plurality of struts 1532 and the second plurality of struts 1534 can be arranged in any number of rows in any configuration (for example, a configuration where the rows of the first plurality of struts 1532 and rows of the second plurality of struts 1534 do not alternate).
  • FIG. 22 is a flattened view of a frame 1630 of a valve positioning structure, according to one example.
  • a valve positioning structure of a delivery apparatus can be formed at least in part by shape setting the frame 1630 in a radially compressed state (for example, in the shape of the valve positioning structure 525 shown in FIG. 10A).
  • the frame 1630 can comprise a distal valve positioning portion 1626, a proximal valve positioning portion 1628 proximally disposed relative to the distal valve positioning portion 1626, and the intermediate valve positioning portion 1029 disposed between the distal valve positioning portion 1626 and the proximal valve positioning portion 1628.
  • the proximal valve positioning portion 1628 and the distal valve positioning portion 1626 have the same structure.
  • the distal valve positioning portion 1626 can be axially longer than the proximal valve positioning portion 1628.
  • the first plurality of stmts 1632 can be arranged into rows 1644, 1648, 1652, 1656 that each extend in a circumferential direction of the frame 1630. Each one of the first plurality of struts 1632 can be oriented at an angle relative to an axial direction of the frame 1630. Each one of the first plurality of struts 1632 can comprise a distal end and a proximal end. The distal ends of adjacent ones of the first plurality of struts 1632 can be connected at apices 1683d. The proximal ends of adjacent ones of the first plurality of struts 1632 can be connected at curved or rounded apices 1683p.
  • the second plurality of struts 1634 can be arranged into rows 1646, 1650, 1654 that each extend in the circumferential direction of the frame 1630.
  • Each one of the second plurality of struts 1634 can be a strut that forms one or more curves.
  • each one of the second plurality of struts 1634 forms four alternating curves that each extend less than 180 degrees.
  • Each one of the second plurality of struts 1634 can comprise a distal end and a proximal end. The distal end of each one of the second plurality of struts 1634 can be connected to a corresponding one of apices 1683d.
  • each one of the second plurality of struts 1634 can be connected to a corresponding one of apices 1683p.
  • the second plurality of struts 1634 (which are capable of a greater degree of elongation than the first plurality of struts 1632) can better allow the frame 1630 to expand in its axial direction.
  • only one of the distal valve positioning portion 1626 and the proximal valve positioning portion 1628 is formed with the depicted pattern of struts, while the respective other positioning portion can exhibit a different pattern of struts, for example, such as described elsewhere herein.
  • the intermediate valve positioning portion 1029 can be formed with a different pattern of struts than the depicted pattern of axially extending connecting struts 1065, for example, with any of the patterns described herein in conjunction with a distal or proximal valve positioning portion.
  • FIG. 23 is a flattened view of a frame 1730 of a valve positioning structure, according to one example.
  • a valve positioning structure of a delivery apparatus can be formed at least in part by shape setting the frame 1730 in a radially compressed state (for example, in the shape of the valve positioning structure 525 shown in FIG. 10A).
  • the frame 1730 can comprise a distal valve positioning portion 1726, a proximal valve positioning portion 1728 proximally disposed relative to the distal valve positioning portion 1726, and the intermediate valve positioning portion 1029 disposed between the distal valve positioning portion 1726 and the proximal valve positioning portion 1728.
  • the proximal valve positioning portion 1728 and the distal valve positioning portion 1726 have the same structure.
  • the distal valve positioning portion 1726 can be axially longer than the proximal valve positioning portion 1728.
  • valve positioning portions 1726, 1728 can share certain similarities with the valve positioning portions 1626, 1628 illustrated in FIG. 22.
  • One exemplary difference between the valve positioning portions 1726, 1728 and the valve positioning portions 1626, 1628 is that each of the distal valve positioning portion 1726 and the proximal valve positioning portion 1728 can include a second plurality of struts 1734 instead of the second plurality of struts 1634 illustrated in FIG. 22.
  • each one of the second plurality of struts 1734 is a curved or serpentine strut that forms four alternating semicircular curves or turns.
  • the second plurality of struts 1734 (which are capable of a greater degree of elongation than the first plurality of struts 1632) can better allow the frame 1730 to expand in its axial direction.
  • the second plurality of struts 1734 are arranged into circumferentially extending rows 1746, 1750, 1754.
  • rows 1746, 1750, 1754 are arranged in an alternating pattern with rows 1644, 1648, 1652, 1656.
  • only one of the distal valve positioning portion 1726 and the proximal valve positioning portion 1728 is formed with the depicted pattern of struts, while the respective other positioning portion can exhibit a different pattern of struts, for example, such as described elsewhere herein.
  • the intermediate valve positioning portion 1029 can be formed with a different pattern of struts than the depicted pattern of axially extending connecting struts 1065, for example, with any of the patterns described herein in conjunction with a distal or proximal valve positioning portion.
  • FIG. 24A is a side view of a distal end portion of a delivery apparatus 1800, according to one example.
  • the delivery apparatus 1800 includes the intermediate shaft 106, the inner shaft 108, the balloon 118, and the nose cone 122. As shown, the balloon 118 is shown in a deflated state.
  • the delivery apparatus 1800 includes a valve positioning structure 1825 disposed around the balloon 118.
  • the valve positioning structure 1825 includes a frame 1830, which is further described with respect to FIG. 24C.
  • FIG. 24C is a flattened view of the frame 1830 of the valve positioning structure 1825, according to one example.
  • the frame 1830 can comprise a distal valve positioning portion 1826, a proximal valve positioning portion 1828 proximally disposed relative to the distal valve positioning portion 1826, and the intermediate valve positioning portion 1029 disposed between the distal valve positioning portion 1826 and the proximal valve positioning portion 1828.
  • the proximal valve positioning portion 1828 and the distal valve positioning portion 1826 have the same structure.
  • the distal valve positioning portion 1826 can be axially longer than the proximal valve positioning portion 1828.
  • each one of the second plurality of struts 1834 has a zigzag or sawtooth shape that extends in an axial direction of the frame 1830.
  • the second plurality of struts 1834 which can elongate to a greater degree than the first plurality of struts 1632, can better allow the frame 1830 to expand in its axial direction.
  • the second plurality of struts 1834 can elongate to a greater degree than the second plurality of struts 1634 illustrated in FIG. 22.
  • the second plurality of struts 1834 are arranged into circumferentially extending rows 1846, 1850, 1854 that alternate with rows 1644, 1648, 1652, 1656 of the first plurality of struts 1632.
  • only one of the distal valve positioning portion 1826 and the proximal valve positioning portion 1828 is formed with the depicted pattern of struts, while the respective other positioning portion can exhibit a different pattern of struts, for example, such as described elsewhere herein.
  • the intermediate valve positioning portion 1029 can be formed with a different pattern of struts than the depicted pattern of axially extending connecting struts 1065, for example, with any of the patterns described herein in conjunction with a distal or proximal valve positioning portion.
  • FIG. 25 is a flattened view of a portion of a frame 1930 of a valve positioning structure, according to one example.
  • a valve positioning structure of a delivery apparatus can be formed at least in part by shape setting the frame 1930 in a radially compressed state (for example, in the shape of the valve positioning structure 525 shown in FIG. 10A).
  • the illustrated portion can be a distal portion (for example, a distal valve positioning portion) or a proximal portion (for example, a proximal valve positioning portion) of the frame 1930.
  • the illustrated portion of the frame 1930 comprises a plurality of struts including the first plurality of struts 1632, the second plurality of struts 1834, and a third plurality of struts 1934.
  • each one of the third plurality of struts 1934 is a linear strut oriented in an axial direction of the frame 1930.
  • ones of the second plurality of struts 1834 and ones of the third plurality of struts 1934 are arranged a pattern of struts that extend in a circumferential direction of the frame 1930 and form circumferentially-extending rows 1950, 1954.
  • each row 1950, 1954 includes three adjacent ones of the second plurality of struts 1834 that alternate with three adjacent ones of the third plurality of struts 1934.
  • this alternating pattern of the second plurality of struts 1834 and the third plurality of struts 1934 can provide the resulting valve positioning structure and/or delivery apparatus with a desirable balance of flexibility and axial strength that better allows the delivery apparatus to navigate the patient’s vasculature (for example, the aortic arch).
  • FIG. 26 is a flattened view of a frame 2030 of a valve positioning structure, according to one example.
  • a valve positioning structure of a delivery apparatus can be formed at least in part by shape setting the frame 2030 in a radially compressed state (for example, in the shape of the valve positioning structure 525 shown in FIG. 10A).
  • the frame 2030 can comprise a distal valve positioning portion 2026, a proximal valve positioning portion 2028 proximally disposed relative to the distal valve positioning portion 2026, and an intermediate valve positioning portion 2029 disposed between the distal valve positioning portion 2026 and the proximal valve positioning portion 2028.
  • the proximal valve positioning portion 2028 and the distal valve positioning portion 2026 have the same structure.
  • the distal valve positioning portion 2026 can be axially longer than the proximal valve positioning portion 2028.
  • Each one of the valve positioning portions 2026, 2028 includes a plurality of struts that includes the first plurality of struts 1632 and a second plurality of struts 2034.
  • the second plurality of struts are arranged into rows 2046, 2050, 2054.
  • the second plurality of struts 2034 are arranged such that a portion of each one of the second plurality of struts 2034 overlaps a corresponding portion of a circumferentially adjacent one of the second plurality of struts 2034 when the second plurality of struts 2034 are arranged into rows 2046, 2050, 2054. In this way, the second plurality of struts 2034 can provide the frame 2030 with improved strength when the frame 2030 deforms.
  • the intermediate valve positioning portion 2029 can optionally include a plurality of connecting struts 2065 (which are also referred to herein as a “plurality of axial linear connecting struts,” a “plurality of axial connecting struts,” and/or a “plurality of linear connecting struts”).
  • a plurality of connecting struts 2065 which are also referred to herein as a “plurality of axial linear connecting struts,” a “plurality of axial connecting struts,” and/or a “plurality of linear connecting struts”.
  • One exemplary difference between plurality of connecting struts 2065 and the plurality of connecting struts 1065 illustrated, for example, in FIGS. 16, 18-20 and 22-24 is that each one of the plurality of connecting struts 2065 can have a longer axial length than each one of the plurality of connecting struts 1065.
  • only one of the distal valve positioning portion 2026 and the proximal valve positioning portion 2028 is formed with the depicted pattern of struts, while the respective other positioning portion can exhibit a different pattern of struts, for example, such as described elsewhere herein.
  • the intermediate valve positioning portion 2029 can be formed with a different pattern of struts than the depicted pattern of axially extending connecting struts 2065, for example, with any of the patterns described herein in conjunction with a distal or proximal valve positioning portion.
  • FIG. 27 is a flattened view of a frame 2130 of a valve positioning structure, according to one example.
  • a valve positioning structure of a delivery apparatus can be formed at least in part by shape setting the frame 2130 in a radially compressed state (for example, in the shape of the valve positioning structure 525 shown in FIG. 10A).
  • the frame 2130 can comprise a distal valve positioning portion 2126, a proximal valve positioning portion 2128 proximally disposed relative to the distal valve positioning portion 2126, and the intermediate valve positioning portion 1029 disposed between the distal valve positioning portion 2126 and the proximal valve positioning portion 2128.
  • the proximal valve positioning portion 2128 and the distal valve positioning portion 2126 have the same structure.
  • the distal valve positioning portion 2126 can be axially longer than the proximal valve positioning portion 2128.
  • Each one of the distal valve positioning portion 2126 and the proximal valve positioning portion 2128 includes the plurality of struts that includes the first plurality of struts 1632 and the second plurality of struts 2034.
  • One exemplary difference between the valve positioning portions 2126, 2128 and the valve positioning portions 2026, 2028 illustrated in FIG. 26 is that the second plurality of struts 2034 are arranged into circumferentially-extending rows 2146, 2150, 2154, wherein a greater portion of each one of the second plurality of struts 2034 overlaps a corresponding portion of a circumferentially adjacent one of the second plurality of struts as compared to the arrangement shown in FIG. 26. In this way, this greater circumferential density of the second plurality of struts 2034 can provide a more continuous interface for interaction with a sheath, a prosthetic valve, and/or the subject’s anatomy.
  • only one of the distal valve positioning portion 2126 and the proximal valve positioning portion 2128 is formed with the depicted pattern of struts, while the respective other positioning portion can exhibit a different pattern of struts, for example, such as described elsewhere herein.
  • the intermediate valve positioning portion 1029 can be formed with a different pattern of struts than the depicted pattern of axially extending connecting struts 1065, for example, with any of the patterns described herein in conjunction with a distal or proximal valve positioning portion.
  • FIG. 28 is a flattened view of a portion of a frame 2230 of a valve positioning structure, according to one example.
  • a valve positioning structure of a delivery apparatus can be formed at least in part by shape setting the frame 2230 in a radially compressed state (for example, in the shape of the valve positioning structure 525 shown in FIG. 10A).
  • the illustrated portion of the frame 2230 can be used to form one of a proximal valve positioning structure or a distal valve positioning structure similar to the valve positioning structures shown in FIGS. 5A-5B.
  • the illustrated portion can be a distal portion (for example, a distal valve positioning portion) or a proximal portion (for example, a proximal valve positioning portion) of the frame 2230.
  • the illustrated portion of the frame 2230 can include a plurality of struts, including a first plurality of struts 2232, a second plurality of struts 2233, a third plurality of struts 2234, a fourth plurality of struts 2236, a fifth plurality of struts 2238, a sixth plurality of struts 2240, and a seventh plurality of struts 2242.
  • the illustrated portion of the frame 2230 can also include a plurality of axially extending crossbars 2263.
  • the first plurality of struts 2232 (which are also referred to herein as a “plurality of axial linear struts,” a “plurality of axial struts,” and/or a “plurality of linear struts”) can be oriented in an axial direction of the frame 2230.
  • the second plurality of struts 2233 (which are also referred to herein as a “plurality of circumferential linear struts,” a “plurality of circumferential struts,” and/or a “plurality of linear struts”) can be oriented in the circumferential direction of the frame 2230.
  • Each one of the plurality of axially extending crossbars 2263 can extend in the axial direction to connect axially adjacent ones of the second plurality of struts 2233.
  • the first and second pluralities of struts 2232, 2233 and the axial crossbars 2263 can be arranged to form a plurality of cross-shaped or “t”-shaped cells 2270 that extend in a circumferentially-extending row.
  • the cross-shaped or “t”-shaped cells 2270 can elongate and/or expand in both the circumferential direction and the axial direction to provide the frame 2230 (or at least a portion thereof) with greater flexibility as compared to frames with other arrangements of struts.
  • the third plurality of struts 2234 (which are also referred to herein as a “plurality of angled linear struts,” a “plurality of angled struts,” and/or a “plurality of linear struts”) can be arranged in a circumferentially-extending row 2246 proximally disposed relative the first and second pluralities of struts 2232, 2233. Each one of the third plurality of struts 2234 can be oriented at an angle relative to the axial direction of the frame 2230.
  • the fourth plurality of struts 2236 (which are also referred to herein as a “plurality of serpentine struts,” a “plurality of sinusoidal struts,” and/or a “plurality of s-struts”) can be arranged in a circumferentially-extending row 2248 proximally disposed relative to row 2246.
  • the fifth plurality of struts 2238 (which are also referred to herein as a “plurality of angled linear struts,” a “plurality of angled struts,” and/or a “plurality of linear struts”) can be arranged in a circumferentially-extending row 2250 that is proximally disposed relative to row 2248.
  • the sixth plurality of struts 2240 (which are also referred to herein as a “plurality of serpentine struts,” a “plurality of sinusoidal struts,” and/or a “plurality of s-struts”) can be arranged in a circumferentially-extending row 2252 proximally disposed relative to row 2250.
  • the seventh plurality of struts 2242 (which are also referred to herein as a “plurality of angled linear struts,” a “plurality of angled struts,” and/or a “plurality of linear struts”) can be arranged in a circumferentially-extending row 2254 that is proximally disposed relative to row 2252.
  • FIG. 29A is a side view of a distal end portion of a delivery apparatus 2300, according to one example.
  • the delivery apparatus 2300 includes the intermediate shaft 106, the inner shaft 108, the balloon 118, and the nose cone 122. As shown, the balloon 118 is shown in a deflated state.
  • the delivery apparatus 2300 includes a valve positioning structure 2325 disposed around the balloon 118.
  • the valve positioning structure 2325 includes a frame 2330, which is further described with respect to FIG. 29C.
  • valve positioning structure 2325 prevents the prosthetic valve 150 from contacting the balloon 118. Furthermore, no portion of the valve positioning structure 2325 overlaps the outer surface of the prosthetic valve 150.
  • FIG. 29B is a side view of the distal end portion of the delivery apparatus 2300, wherein the balloon 118 is in an inflated state and the valve positioning structure is in a radially expanded state.
  • FIG. 29C is a flattened view of a portion of the frame 2330 of the valve positioning structure 2325, according to one example.
  • the illustrated portion can be a distal portion (for example, a distal valve positioning portion) or a proximal portion (for example, a proximal valve positioning portion) of the frame 2330.
  • the frame 2330 comprises a first plurality of struts 2332 (which are also referred to herein as a “plurality of angled linear struts,” a “plurality of angled struts,” and/or a “plurality of linear struts”) instead of the first and second pluralities of struts 2232, 2233.
  • the first plurality of struts 2332 can be arranged in a circumferentially-extending row 2344.
  • the row 2344 can be distally disposed relative to row 2246 of the third plurality of struts 2234.
  • the first plurality of struts 2332 and the third plurality of struts 2234 can form a plurality of diamond- shaped cells 2370.
  • the plurality of diamond- shaped cells 2370 can keep pleats of a balloon of a resulting delivery apparatus (for example, any one of balloons 118, 218, 318, 418) folded when the balloon is in the deflated state.
  • FIG. 30 is a side view of a flattened distal valve positioning structure 2426, a flattened proximal valve positioning structure 2428, and a plurality of tethers 2492 coupling the distal valve positioning structure 2426 and the proximal valve positioning structure 2428 together, according to one example.
  • at least one of the distal valve positioning structure 2426, the proximal valve positioning structure 2428, and the plurality of tethers 2492 can optionally extend over at least a portion of a balloon of a delivery apparatus (for example, the balloon 118).
  • distal valve positioning structure 2426 and/or the proximal valve positioning structure 2428 are in a non-flattened state when they extend over at least a portion of the balloon.
  • distal valve positioning structure 2426, the proximal valve positioning structure 2428, and the plurality of tethers 2492 can be used in lieu of the balloon to form a valve mounting portion of the delivery apparatus.
  • At least one of the distal valve positioning structure 2426, the proximal valve positioning structure 2428, and one or more of the plurality of tethers 2492 can optionally be fixedly coupled to (for example, adhered to, joined to, mechanically fastened to, reflowed onto, etc.) the balloon of the delivery apparatus (for example, the balloon 118) or another adjacent component of the delivery apparatus such that the position of the distal valve positioning structure 2426, the proximal valve positioning structure 2428, and/or the plurality of tethers 2492 are fixed relative to the balloon.
  • the distal valve positioning structure 2426 can optionally be fixedly coupled to a distal end portion of the balloon and/or a nosecone (for example, nosecone 122).
  • the proximal valve positioning structure 2428 can optionally be fixedly coupled to a proximal end portion of the balloon and/or a shaft of the delivery apparatus (for example, shaft 106). In some examples, fixedly coupling only one of the distal valve positioning structure 2426 and the proximal valve positioning structure 2428 to the balloon can permit the other valve positioning structure to move relative to the balloon, thereby allowing an axial spacing 2494 between the distal valve positioning structure 2426 and the proximal valve positioning structure 2428 to be increased or decreased during a delivery procedure. Additionally or alternatively, one or more of the plurality of tethers 2492 can be fixedly coupled to the balloon. In some examples, none of the distal valve positioning structure 2426, the proximal valve positioning structure 2428, and one or more of the plurality of tethers 2492 are fixed or secured to the balloon or other components of the delivery apparatus.
  • each one of the distal valve positioning structure 2426 and the proximal valve positioning structure 2428 optionally includes a frame 2430 formed from a first plurality of struts 2432 and a second plurality of struts 2434 arranged in alternating, circumferentially-extending rows.
  • each frame 2430 can further include a third plurality of struts 2488 arranged to form an end portion of the frame 2430.
  • the third plurality of struts 2488 can be arranged to form a proximal end portion of the frame 2430.
  • the third plurality of struts 2488 can be arranged to form a distal end portion of the frame 2430.
  • one of the distal valve positioning structure 2426 and the proximal valve positioning structure 2428 can optionally have a different structure (for example, a different frame including a different arrangement of struts).
  • a different structure for example, a different frame including a different arrangement of struts.
  • only one of the distal valve positioning structure 2426 and the proximal valve positioning structure 2428 can be formed with the depicted pattern of struts, while the respective other positioning portion can exhibit a different pattern of struts, for example, such as any pattern described elsewhere herein.
  • valve positioning structures 2426, 2428 can optionally be provided in a form other than the frame 2430, such as any of the other possible variations disclosed elsewhere herein. This includes, but is not limited to, a polymeric (for example, elastomeric) coating of the balloon 118. In other examples, one or both valve positioning structures 2426, 2428 can another frame configuration, as any of those disclosed herein.
  • the distal valve positioning structure 2426 optionally includes at least one eyelet 2490a (for example, a plurality of eyelets 2490a) and the proximal valve positioning structure 2428 optionally includes at least one eyelet 2490b (for example, a plurality of eyelets 2490b).
  • each eyelet 2490a can optionally be formed at a proximal-most end of a corresponding one of the third plurality of struts 2488 while on the proximal valve positioning structure 2428, each eyelet 2490b can optionally be formed at a distal-most end of a corresponding one of the third plurality of struts 2488.
  • the eyelets 2490a, 2490b can be formed on any portion of their respective valve positioning structures 2426, 2428, such as on a portion spaced from a proximal and/or distal end of the valve positioning structures 2426, 2428.
  • the eyelets 2490a, 2490b are optionally arranged in circumferentially-extending rows.
  • the eyelets 2490a, 2490b can optionally be spaced apart from each other in an axial direction to form at least one row that extends at least partially in the axial direction.
  • the eyelets 2490a, 2490b can be arranged on their respective valve positioning structures 2426, 2428 in any pattern, for example, such as any pattern described elsewhere herein.
  • the distal valve positioning structure 2426 and/or the proximal valve positioning structure 2428 can alternatively include one or more non-eyelet structures for engaging and/or retaining the tethers 2492, such as hooks, flanges, bollards, notches, pulley wheels, etc.
  • the distal valve positioning structure 2426 and/or the proximal valve positioning structure 2428 can optionally include a combination of non-eyelet structures and their respective eyelets 2490a, 2490b.
  • the plurality of tethers 2492 can optionally be used to couple the valve positioning structures 2426, 2428 together. As shown, each one of the plurality of tethers 2492 includes a distal end portion coupled to one of the eyelets 2490a of the distal valve positioning structure 2426 and a proximal end portion coupled to a corresponding one of the eyelets 2490b of the proximal valve positioning structure 2428. As shown, the end portions of the tether 2492 are optionally tied to the eyelets 2490a, 2490b.
  • one or more of the end portions of one or more of the tether 2492 can optionally be coupled to the eyelets 2490a, 2490b using other means, such as by adhering the ends of the tether 2492 to the eyelets 2490a, 2490b, reflowing the ends of the tether 2492 onto the eyelets 2490a, 2490b, mechanically fastening the ends of the tether 2492 to the eyelets 2490a, 2490b, etc.
  • one or more axial stmts can optionally be used to couple the valve positioning stmctures
  • a combination of one or more axial struts and one or more of the plurality of tethers 2492 can be used to couple the valve positioning structures 2426, 2428 together.
  • the valve positioning structures 2426, 2428 are spaced apart from each other in the axial direction by the axial spacing 2494.
  • the axial spacing 2494 (which is also referred to herein as a “shoulder-to-shoulder distance”) is defined herein as the axial distance between the proximal end of the distal valve positioning structure 2426 (which is also referred to as a “distal shoulder”) and the distal end of the proximal valve positioning structure 2428 (which is also referred to as a “proximal shoulder”) when the valve positioning structures 2426, 2428 are coupled to a balloon (for example, the balloon 118).
  • the axial spacing 2494 can optionally be substantially equal to (for example, ⁇ 10%) an axial length of a valve mounting portion (for example, the valve mounting portion 128) of a delivery apparatus and/or an axial length of a prosthetic valve (for example, the prosthetic valve 150), for example, when the prosthetic valve is in a radially collapsed state and crimped around the distal end of the delivery apparatus.
  • having the axial spacing 2494 be substantially equal to the length of the valve mounting portion and/or the axial length of the prosthetic valve can allow both valve positioning structures 2426, 2428 to better engage the end portions of the prosthetic valve crimped around the delivery apparatus, thereby further reducing any axial movement of the prosthetic valve during a delivery procedure.
  • the axial spacing 2494 can optionally be greater than the axial length of the valve mounting portion and/or the axial length of the prosthetic valve, for example, when the prosthetic valve is mounted around the valve mounting portion.
  • the prosthetic valve can be crimped around the plurality of tethers 2492 in a way that avoids or minimizes direct contact between the prosthetic valve and the struts 2432, 2434, 2488 of the valve positioning structures 2426, 2428.
  • the axial spacing 2494 can optionally remain constant during the delivery procedure.
  • the axial spacing 2494 can remain constant as the valve positioning structures 2426, 2428 and/or prosthetic valve are expanded to their respective radially expanded states.
  • one or more of the plurality of tethers 2492 can optionally be formed from a flexible, substantially non-elastic material.
  • suitable non- elastic materials include one of or a blend of ultra-high-molecular-weight polyethylene (UHMWPE) (examples of which are sold under the name Dyneema® by A Sol Corporation of Avon Lake, Ohio and under the name Force Fiber® by Teleflex Medical OEM of Madison, Minnesota), high-density polyethylene (HDPE), polyetherketone (PEEK), polyvinyl chloride (PVC), polyimide, etc.
  • UHMWPE ultra-high-molecular-weight polyethylene
  • HDPE high-density polyethylene
  • PEEK polyetherketone
  • PVC polyvinyl chloride
  • polyimide etc.
  • the tethers 2492 can be configured as sutures, such as single filament sutures or multi-filament sutures (for example, braided sutures or sutures with twisted filaments), which can be made of such materials.
  • forming one or more of the plurality of tethers 2492 from a substantially non-elastic material can prevent or minimize the degree to which the plurality of tethers 2492 stretch axially when the valve positioning structures 2426, 2428 are radially expanded or collapsed, thereby allowing the axial spacing 2494 to remain relatively constant as the valve positioning structures 2426, 2428 are radially expanded or collapsed.
  • the one or more of the plurality of tethers 2492 can optionally be formed from a substantially elastic material.
  • suitable elastic materials include one of or a blend of low density polyethylene (LDPE), nylon, polyethylene (PE), polypropylene (PE), polyurethane (PU), etc.
  • LDPE low density polyethylene
  • PE polyethylene
  • PE polypropylene
  • PU polyurethane
  • forming one or more of the plurality of tethers 2492 from a substantially elastic material can allow the axial spacing 2494 to decrease or increase as the valve positioning structures 2426, 2428 are radially expanded or collapsed, respectively.
  • this can beneficially allow the valve positioning structures 2426, 2428 to continue to engage the ends of the prosthetic valve as the prosthetic valve radially expands and foreshortens, thereby further minimizing any axial movement of the prosthetic valve relative to the delivery apparatus as the prosthetic valve is radially expanded.
  • the substantially elastic material can be selected such that the axial spacing 2494 decreases at substantially the same rate as the decreasing axial length of the foreshortening prosthetic valve.
  • the plurality of tethers 2492 can optionally be formed from a combination of substantially elastic and substantially non-elastic materials.
  • a first subset of the plurality of tethers 2492 can be formed from a substantially elastic material and a second plurality of tethers 2492 can be formed from a substantially non-elastic material.
  • one or more of the plurality of tethers 2492 can be formed from a blend of substantially elastic material and substantially non-elastic material.
  • one or more of the plurality of tethers 2492 can optionally be configured as sutures, such as single filament sutures or multi-filament sutures (for example, braided sutures or sutures with twisted filaments), which can be made of any of the materials discussed above.
  • the tethers 2492 can be braided sutures, such as made of UHMWPE filaments (for example, Force Fiber® sutures).
  • Other suture material can include gut, polydioxanone (PDS), nylon, polypropylene (PP), silk, polyester, etc.
  • the plurality of tethers 2492 can be beneficial to use the plurality of tethers 2492 instead of a plurality of struts to couple the valve positioning structures 2426, 2428 because the material used to form the plurality of tethers 2492 (for example, UHMWPE) can have a higher tensile strength and/or modulus of elasticity than the material used to form the struts 2432, 2434 (for example, Nitinol).
  • the tethers 2492 can be configured to exhibit the same mechanical performance as struts but have a smaller cross-section than the struts.
  • the smaller crosssection of the tethers 2492 can beneficially allow the prosthetic valve to be more compactly crimped around the distal end portion of the delivery apparatus, thereby further reducing the diameter of the crimped prosthetic valve.
  • the use of the plurality of tethers 2492 instead of a plurality of struts to couple the valve positioning structures 2426, 2428 can decrease the overall cost of the delivery apparatus.
  • the tethers 2492 can be formed from a material (for example, UHMWPE) that is typically cheaper than the material used to form struts (for example, Nitinol).
  • manufacturing two smaller valve positioning structures 2426, 2428 connected using the plurality of tethers 2492 rather than a single, larger valve positioning structure formed solely from struts can reduce manufacturing costs because fewer cuts (for example, laser cuts) are required.
  • manufacturing two smaller valve positioning structures 2426, 2428 and coupling them together with the plurality of tethers 2492 can be cheaper than manufacturing a single, larger valve positioning structure because if a defect is found in one of the valve positioning structures 2426, 2428, only one of the two smaller valve positioning structures (rather than the entirety of the single, larger valve positioning structure) needs to be scrapped and/or replaced.
  • coupling the valve positioning structures 2426, 2428 together using the plurality of tethers 2492 can be advantageous in situations where it is desirable to maintain a constant axial spacing 2494 as the valve positioning structures 2426, 2428 are radially expanded or collapsed.
  • a circumferential spacing 2496 between the eyelets for example, adjacent ones of eyelets 2490a, 2490b
  • the increase in circumferential spacing 2496 is not effective to shorten the axial length of the plurality of tethers 2492 and/or shorten the axial spacing 2494 because the plurality of tethers 2492 only extend in the axial direction.
  • FIG. 31 is a side view of a proximal end portion of a distal valve positioning structure 2526 and a distal end portion of the proximal valve positioning structure 2528 coupled together via a tether 2592, according to one example.
  • the distal valve positioning structure 2626, the proximal valve positioning structure 2628, and the tether 2692 can be used in lieu of a balloon to form a valve mounting portion of the delivery apparatus.
  • At least one of the distal valve positioning structure 2526, the proximal valve positioning structure 2528, and the tether 2592 can optionally be fixedly coupled to (for example, adhered to, joined to, mechanically fastened to, reflowed onto, etc.) the balloon of the delivery apparatus (for example, the balloon 118) or another adjacent component of the delivery apparatus such that the position of the distal valve positioning structure 2526, the proximal valve positioning structure 2528, and/or the tether 2592 are fixed relative to the balloon.
  • none of the distal valve positioning structure 2526, the proximal valve positioning structure 2528, and the tether 2592 are fixedly coupled to any component of the delivery apparatus.
  • each one of the distal valve positioning structure 2526 and the proximal valve positioning structure 2528 optionally includes a frame 2530 formed from a plurality of struts 2588.
  • the frame 2530 can have the same configuration as the frame 2430 depicted in FIG. 30 or any other frame configuration disclosed herein.
  • one of the distal valve positioning structure 2526 and the proximal valve positioning structure 2528 can optionally have a different structure (for example, a different frame including a different arrangement of struts).
  • a different structure for example, a different frame including a different arrangement of struts.
  • only one of the distal valve positioning structure 2526 and the proximal valve positioning structure 2528 can be formed with the depicted pattern of struts, while the respective other positioning portion can exhibit a different pattern of struts, for example, such as any pattern described elsewhere herein.
  • the valve positioning structures 2526, 2528 can optionally be provided in a form other than the frame 2530, such as any of the other possible variations disclosed elsewhere herein. This includes, but is not limited to, a polymeric (for example, elastomeric) coating of the balloon 118.
  • the distal valve positioning structure 2526 includes at least one eyelet 2490a (for example, the plurality of eyelets 2490a) and the proximal valve positioning structure 2528 includes at least one eyelet 2490b (for example, the plurality of eyelets 2490b).
  • each eyelet 2490a can optionally be formed at a proximal-most end of a corresponding one of the plurality of struts 2588 while on the proximal valve positioning structure 2428, each eyelet 2490b can optionally be formed at a distal-most end of a corresponding one of the plurality of struts 2588.
  • the eyelets 2490a, 2490b can be formed on any portion of their respective valve positioning structures 2526, 2528, such as on a portion spaced from a proximal and/or distal end of the valve positioning structures 2526, 2528. As shown, the eyelets 2490a, 2490b are optionally arranged in circumferentially-extending rows. In some examples, the eyelets 2490a, 2490b can optionally be spaced apart from each other in an axial direction to form a row that extends at least partially in the axial direction. However, the eyelets 2490a, 2490b can be arranged on their respective valve positioning structures 2526, 2528 in any pattern, for example, such as any pattern described elsewhere herein.
  • the distal valve positioning structure 2526 and/or the proximal valve positioning structure 2528 can alternatively include one or more non-eyelet structures for engaging and/or retaining the tether 2592, such as hooks, flanges, bollards, notches, pulley wheels, etc.
  • the distal valve positioning structure 2526 and/or the proximal valve positioning structure 2528 can optionally include a combination of non-eyelet structures and their respective eyelets 2490a, 2490b.
  • the distal valve positioning structure 2526 and the proximal valve positioning structure 2528 are coupled together using the tether 2592 rather than a plurality of tethers (for example, tethers 2492).
  • the tether 2592 can comprise a single tether, such as single length of suture material.
  • the tether 2592 is threaded through alternating ones of the eyelets 2490a of the distal valve positioning structure 2526 and the eyelets 2490b of the proximal valve positioning structure 2528.
  • the end portions of the tether 2592 can be secured together, for example, by optionally tying the end portions of the tether 2592 together.
  • the end portions of the tether 2592 can optionally be secured together using other means, such as an adhesive, a mechanical fastener, etc.
  • the end portions of the tether 2592 can optionally be secured together at the location of one of the eyelets 2490a, 2490b or alternatively at a location spaced apart from of one of the eyelets 2490a, 2490b.
  • each tether’s end portion can be tied off or otherwise secured to a respective eyelet 2490a, 2490b or to another convenient location on a respective frame 2530.
  • the tether 2592 can be formed from one of or a blend of the substantially non-elastic materials, the substantially elastic materials, and/or the suture materials described above with respect to the plurality of tethers 2492.
  • tether 2592 rather than the plurality of tethers 2492 to couple the valve positioning structures 2526, 2528 together can beneficially reduce manufacturing costs. For example, forming only one knot to secure the end portions of the tether 2592 together can be simpler (and thus cheaper) than forming a plurality of knots by tying the end portions of each one of the plurality of tethers 2492 to a corresponding one of the eyelets 2490a, 2490b.
  • coupling the valve positioning structures 2526, 2528 together using the tether 2592 can be advantageous in situations where it is desirable to decrease an axial spacing 2594 between the valve positioning structures 2526, 2528 as the valve positioning structures 2526, 2528 are radially expanded or collapsed.
  • an axial spacing 2594 between the valve positioning structures 2526, 2528 as the valve positioning structures 2526, 2528 are radially expanded or collapsed.
  • a circumferential spacing 2596 between adjacent eyelets 2490a, 2490b increases. Since the tether 2592 extends at least partially in both the axial direction and the circumferential direction, the increase in the circumferential spacing 2596 is effective to reduce the axial spacing 2594, thereby pulling the valve positioning structures 2526, 2528 closer together.
  • valve positioning structures 2526, 2528 can beneficially allow the valve positioning structures 2526, 2528 to continue to engage the ends of the prosthetic valve as the prosthetic valve foreshortens.
  • valve positioning structures 2526, 2528 To allow the valve positioning structures 2526, 2528 to move closer together, at least one of the valve positioning structures 2526, 2528 is not fixed relative to the balloon.
  • the threading pattern of FIG. 31 can be used with plural tethers coupling the distal and proximal valve positioning structures 2526, 2528.
  • one tether can be threaded through selected eyelets 2490a, 2490b the distal and proximal valve positioning structures 2526, 2528 with the ends of the tether tied off or otherwise connected to respective eyelets or locations on the struts.
  • One or more additional tethers can be threaded through respective eyelets in the distal and proximal valve positioning structures 2526, 2528 in the same manner.
  • FIG. 32 is a side view of a portion of the distal valve positioning structure 2526 and the portion of the proximal valve positioning structure 2528 coupled together via the tether 2592, according to one example.
  • the tether 2592 is coupled to the valve positioning structures 2526, 2528 in a different configuration. As shown, the tether 2592 is sequentially threaded through two adjacent eyelets 2490a, 2490c of the distal valve positioning structure 2426 and then sequentially threaded through two adjacent eyelets 2490b, 2490d of the proximal valve positioning structure 2428.
  • the tether 2592 can optionally be threaded through a greater number of adjacent eyelets (for example, three, four, five, etc. adjacent eyelets) of at least one of the distal valve positioning structure 2526 and the proximal valve positioning structure 2528.
  • the configuration shown in FIG. 32 can result in a greater decrease of the axial spacing 2594 when the valve positioning structures 2526, 2528 are radially expanded than the configuration shown in FIG. 31.
  • the tether 2592 can be threaded through two or more adjacent eyelets (for example, eyelets 2490a, 2490c or eyelets 2490b, 2490d) such that the tether 2592 extends in the circumferential direction by at least the circumferential spacing 2596.
  • eyelets 2490a, 2490c or eyelets 2490b, 2490d for example, eyelets 2490a, 2490c or eyelets 2490b, 2490d
  • the increase in the circumferential spacing 2596 is effective to cause a corresponding, equal decrease in the axial spacing 2594.
  • decreasing the axial spacing 2594 in this manner can beneficially allow the valve positioning structures 2526, 2528 to continue to engage the ends of the prosthetic valve as the prosthetic valve foreshortens.
  • FIG. 32 Although a single tether 2592 is shown in FIG. 32, in some examples, the threading pattern of FIG. 32 can be used with plural tethers coupling the distal and proximal valve positioning structures 2526, 2528.
  • one tether can be threaded through selected eyelets 2490a, 2490b, 2490c, 2490d of the distal and proximal valve positioning structures 2526, 2528 with the ends of the tether tied off or otherwise connected to respective eyelets or locations on the struts.
  • One or more additional tethers can be threaded through respective eyelets in the distal and proximal valve positioning structures 2526, 2528 in the same manner.
  • the tether 2592 can comprise a single tether, such as a single length of suture material.
  • at least one of the distal valve positioning structure 2626, the proximal valve positioning structure 2628, and the plurality of tethers 2692 can optionally extend over at least a portion of a balloon of a delivery apparatus (for example, the balloon 118).
  • the distal valve positioning structure 2626, the proximal valve positioning structure 2628, and the tether 2692 can be used in lieu of balloon to form a valve mounting portion of the delivery apparatus.
  • At least one of the distal valve positioning structure 2626, the proximal valve positioning structure 2628, and the tether 2692 can optionally be fixedly coupled to (for example, adhered to, joined to, mechanically fastened to, reflowed onto, etc.) the balloon of the delivery apparatus (for example, the balloon 118) or to another adjacent component of the delivery apparatus such that the position of the distal valve positioning structure 2626, the proximal valve positioning structure 2628, and/or the tether 2692 are fixed relative to the balloon.
  • the distal valve positioning structure 2626 can optionally be fixedly coupled to a distal end portion of the balloon.
  • the proximal valve positioning structure 2628 can optionally be fixedly coupled to a proximal end portion of the balloon.
  • the tether 2692 can be fixedly coupled to the balloon.
  • each one of the distal valve positioning structure 2626 and the proximal valve positioning structure 2628 optionally includes a frame 2630 formed from a plurality of struts 2688 arranged into at least one circumferentially-extending row (for example, at least two circumferentially-extending rows as shown).
  • each frame 2630 includes at least one eyelet (for example, a plurality of eyelets).
  • the frame 2630 of the distal valve positioning structure 2626 includes eyelets 2690a, 2690c formed at a proximal -most end of a corresponding apex of two adjacent struts 2688.
  • the frame 2630 of the proximal valve positioning structure 2628 includes eyelets 2690b, 2690d formed at a distal-most end of a corresponding apex of two adjacent struts 2688.
  • the eyelets 2690a, 2690b, 2690c, 2690d can be formed on any portion of their respective valve positioning structures 2626, 2628, such as on a portion spaced from a proximal end and/or a distal end of the valve positioning structures 2626, 2628.
  • the eyelets 2690a, 2690c and 2690b, 2690d are optionally arranged in circumferentially-extending rows.
  • the eyelets 2690a, 2690c and 2690b, 2690d can optionally be spaced apart from each other in an axial direction to form a row that extends at least partially in the axial direction.
  • the eyelets 2690a, 2690c and 2690b, 2690d can be arranged on their respective valve positioning structures 2626, 2628 in any pattern, for example, such as any pattern described elsewhere herein.
  • the distal valve positioning structure 2626 and/or the proximal valve positioning structure 2628 can alternatively include one or more non-eyelet structures for engaging and/or retaining the tether 2692, such as hooks, flanges, bollards, notches, pulley wheels, etc.
  • the distal valve positioning structure 2626 and/or the proximal valve positioning structure 2628 can optionally include a combination of non-eyelet structures and their respective eyelets 2690a, 2690c and 2690b, 2690d.
  • the distal valve positioning structure 2626 optionally includes one or more notches 2697a formed at a junction of two adjacent ones of the plurality of struts 2688
  • the proximal valve positioning structure 2628 optionally includes one or more notches 2697b formed at a junction of two adjacent ones of the plurality of struts 2688.
  • at least one of the valve positioning structures 2626, 2628 can optionally include an eyelet, a pulley wheel, a hook, a bollard, etc. in lieu of at least one of the notches 2697a, 2697b.
  • the distal valve positioning structure 2626 and/or the proximal valve positioning structure 2628 can optionally lack at least one of the illustrated notches 2697a, 2697b.
  • one of the distal valve positioning structure 2626 and the proximal valve positioning structure 2628 can optionally have a different structure (for example, a different frame including a different arrangement of struts).
  • a different structure for example, a different frame including a different arrangement of struts.
  • only one of the distal valve positioning structure 2626 and the proximal valve positioning structure 2628 can be formed with the depicted pattern of struts, while the respective other positioning portion can exhibit a different pattern of struts, for example, such as any pattern described elsewhere herein.
  • the valve positioning structures 2626, 2628 can optionally be provided in a form other than the frame 2630, such as any of the other possible variations disclosed elsewhere herein. This includes, but is not limited to, a polymeric (for example, elastomeric) coating of the balloon 118.
  • the tether 2692 can be configured to couple the valve positioning structures 2626, 2628 together. As shown, the tether 2692 is threaded through an eyelet 2690a of the distal valve positioning structure 2626, looped around the notch 2697a of the distal valve positioning structure 2626, and threaded through an eyelet 2690c, which is adjacent the eyelet 2690a. The tether 2692 is subsequently threaded through an eyelet 2690b of the proximal valve positioning structure 2628, looped around the notch 2697b of the proximal valve positioning structure 2628, and threaded through an eyelet 2690d, which is adjacent the eyelet 2690b.
  • the tether 2692 can then extend back to the distal valve positioning structure 2626, where the pattern of threading the tether 2692 through a pair of eyelets 2690a, 2690c and a notch 2697a is repeated, and then can extend back to the proximal valve positioning structure 2628. In some examples, this pattern can be repeated as desired so that the tether 2692 extends through each eyelet around the circumference of the distal and proximal valve positioning structures 2626, 2628. As shown, the end portions of the tether 2692 are optionally tied together at the knot 2693. In some examples, the end portions of the tether 2692 can optionally be secured together using other means, such as an adhesive, a mechanical fastener, etc.
  • the end portions of the tether 2692 can optionally be secured together at a location spaced apart from of the eyelets 2690a, 2690b, 2690c, 2690d and notches 2697a, 2697b. In some examples, the end portions of the tether 2692 can optionally be secured together at the location of one of the eyelets 2690a, 2690b, 2690c, 2690d or at the location of one of the notches 2697a, 2697b.
  • the tether 2692 can be formed from one of or a blend of the substantially non-elastic materials, the substantially elastic materials, and/or the suture materials described above with respect to the plurality of tethers 2492 and/or the tether 2592.
  • the illustrated configuration of the tether 2692 can beneficially combine different benefits of the examples shown in FIGS. 30 and 31 .
  • it can be desirable to route the tether 2692 along the length of one of the struts 2688 between an eyelet and a notch (for example, between eyelet 2690a and notch 2697a or between eyelet 2690b and notch 2697b).
  • routing the tether 2692 along the length of those struts 2688, which do not change in length as the valve positioning structures 2626, 2628 are radially expanded or compressed, can maintain a constant axial spacing 2694 as the balloon is inflated to radially expand valve positioning structures 2626, 2628.
  • forming only one knot to secure the end portions of the tether 2692 together can be simpler (and thus cheaper) than tying the end portions of each one of a plurality of tethers to a corresponding one of the eyelets.
  • the configuration of the tether 2692 can beneficially further minimize any changes in the axial spacing 2694 (in situations where maintaining a constant axial spacing 2694 is desirable) while further reducing manufacturing complexity.
  • the threading pattern of FIG. 33 can be used with plural tethers coupling the distal and proximal valve positioning structures 2626, 2628.
  • one tether can be threaded through a pair of eyelets 2690a, 2690b and a notch 2697a of the distal valve positioning structure 2626 and a pair of eyelets 2690b, 2690d and a notch 2697b of the proximal valve positioning structure 2628 with the ends of the tether tied off or otherwise connected to respective eyelets or locations on the struts.
  • One or more additional tethers can be threaded through respective eyelets and notches in the distal and proximal valve positioning structures 2626, 2628 in the same manner.
  • the frames 2630 can be formed without notches 2697a, 2697b, in which case the tether 2692 is wrapped around the junction formed by two adjacent struts 2688.
  • FIG. 34 is a side view of a portion of a distal valve positioning structure 2726 and a portion of a proximal valve positioning structure 2728 coupled via the tether 2692, according to one example.
  • One exemplary difference between the valve positioning structures 2726, 2728 and the valve positioning structures 2626, 2628 shown in FIG. 33 is that at least one of the valve positioning structures 2726, 2728 can optionally include a strut 2798 (which is also referred to herein as an “axial strut”) and an eyelet (for example, one of eyelets 2790e, 2790f) at an end portion of the strut 2798 for routing the tether 2692.
  • a strut 2798 which is also referred to herein as an “axial strut”
  • an eyelet for example, one of eyelets 2790e, 2790f
  • a frame 2730 of the distal valve positioning structure 2726 optionally includes at least two struts 2798.
  • Each strut 2798 extends in a proximal direction from a junction of two of the struts 2688 and includes an eyelet 2790e formed at a proximal end portion of the strut 2798.
  • the frame 2730 of the proximal valve positioning structure 2728 optionally includes two struts 2798, each extending in a distal direction from a junction of two of the struts 2688 and including an eyelet 2790f formed at a distal end portion of the strut 2798.
  • the tether 2692 is threaded sequentially through the eyelets 2690a, 2790e, 2690c of the distal valve positioning structure 2726 and then sequentially through the eyelets 2690b, 2790f, 2690d of the proximal valve positioning structure 2728. In some examples, this pattern can be repeated so that the tether 2692 extends through each set of three eyelets on the proximal and distal valve positioning structures 2726, 2728.
  • an axial spacing 2794 between opposite eyelets will decrease and a circumferential spacing 2796 between adjacent eyelets (for example, eyelets 2690a, 2690c and 2690b, 2690d) will increase as the valve positioning structures 2726, 2728 are radially expanded.
  • a length 2799 of one or more of the struts 2798 can optionally be configured to achieve a desired degree of reduction in the axial spacing 2794 as the valve positioning structures 2726, 2728 are radially expanded.
  • increasing the length 2799 of one or more of the struts 2798 can be effective to increase the degree of reduction in the axial spacing 2794 as the valve positioning structures 2726, 2728 are radially expanded.
  • decreasing the length 2799 of one or more of the struts 2798 can be effective to decrease the degree of reduction in the axial spacing 2794 as the valve positioning structures 2726, 2728 are radially expanded.
  • the valve positioning structures 2726, 2728 can be configured to achieve a particular degree of change (or lack thereof) in the axial spacing 2794.
  • one or more of the struts 2798 can optionally be configured to have an adjustable length 2799.
  • one or more of the struts 2798 can include a means, such as a linear actuator, a rack and pinon assembly, telescoping struts, etc., that allow the length 2799 of the strut 2798 to be increased or decreased. In this way, the degree of reduction in the axial spacing 2794 can be tuned, for example, to accommodate a prosthetic valve having a different axial length.
  • one or more of the struts 2798 can be replaced with a set of angled or zig-zag struts arranged in an axially extending row, similar to struts 534. The overall axial length of the row of angled struts 2798 can increase in the axial direction as the balloon is inflated.
  • one or more of the struts 2798 can optionally be replaced with a tether.
  • the tether can include a first end portion including an eyelet (which in some examples can be similar to eyelets 2790e, 2790f) through which the tether 2692 can be threaded.
  • a second portion of the tether can extend from the distal portion of the delivery apparatus, for example, to a handle portion of the delivery apparatus.
  • the second end portion of the tether can be manipulated by the delivery apparatus’s user to tune the length 2799. This can be beneficial in situations where the length 2799 and/or the axial spacing 2794 need to be tuned in real time, for example, during a procedure.
  • the threading pattern of FIG. 34 can be used with plural tethers coupling the distal and proximal valve positioning structures 2726, 2728.
  • one tether can be threaded through a set of the eyelets 2690a, 2790e, 2690c of the distal valve positioning structure 2726 and a set of the eyelets 2690b, 27901', 2690d of the proximal valve positioning structure 2728 with the ends of the tether tied off or otherwise connected to respective eyelets or locations on the struts.
  • One or more additional tethers can be threaded through respective eyelets in the distal and proximal valve positioning structures 2726, 2728 in the same manner.
  • proximal and distal valve positioning portions shown in the figures in specific combinations need not necessarily be combined in the depicted way, but that proximal and distal valve positioning portions can be readily combined between the different depicted examples.
  • specific numbers of pluralities of struts forming rows of cells are depicted in the various examples shown in the figures, it is clear that other numbers of rows of cells can also be provided. The same holds true for the specific shape of cells depicted in the figures, which in other examples can differ from what is shown.
  • any of the systems, devices, apparatuses, etc. herein can be sterilized (for example, with heat/thermal, pressure, steam, radiation, and/or chemicals, etc.) to ensure they are safe for use with patients, and any of the methods herein can include sterilization of the associated system, device, apparatus, etc. as one of the steps of the method.
  • heat/thermal sterilization include steam sterilization and autoclaving.
  • radiation for use in sterilization include, without limitation, gamma radiation, ultra-violet radiation, and electron beam.
  • chemicals for use in sterilization include, without limitation, ethylene oxide, hydrogen peroxide, peracetic acid, formaldehyde, and glutaraldehyde. Sterilization with hydrogen peroxide may be accomplished using hydrogen peroxide plasma, for example. Delivery Techniques
  • the prosthetic valve is in some examples mounted in a radially compressed state along the distal end portion of a delivery apparatus.
  • the prosthetic valve and the distal end portion of the delivery apparatus are inserted into a femoral artery and are advanced into and through the descending aorta, around the aortic arch, and through the ascending aorta.
  • the prosthetic valve is positioned within the native aortic valve and radially expanded (for example, by inflating a balloon, actuating one or more actuators of the delivery apparatus, or deploying the prosthetic valve from a sheath to allow the prosthetic valve to self-expand).
  • a prosthetic valve can be implanted within the native aortic valve in a transapical procedure, whereby the prosthetic valve (on the distal end portion of the delivery apparatus) is introduced into the left ventricle through a surgical opening in the chest and the apex of the heart and the prosthetic valve is positioned within the native aortic valve.
  • a prosthetic valve (on the distal end portion of the delivery apparatus) is introduced into the aorta through a surgical incision in the ascending aorta, such as through a partial J-sternotomy or right parasternal mini-thoracotomy, and then advanced through the ascending aorta toward the native aortic valve.
  • a prosthetic valve can be delivered to the native aortic valve via a subclavian artery, an axillary artery, a carotid artery, or via a transcaval delivery procedure.
  • the prosthetic valve is mounted in a radially compressed state along the distal end portion of a delivery apparatus.
  • the prosthetic valve and the distal end portion of the delivery apparatus are inserted into a femoral vein and are advanced into and through the inferior vena cava, into the right atrium, across the atrial septum (through a puncture made in the atrial septum), into the left atrium, and toward the native mitral valve.
  • a prosthetic valve can be implanted within the native mitral valve in a transapical procedure, whereby the prosthetic valve (on the distal end portion of the delivery apparatus) is introduced into the left ventricle through a surgical opening in the chest and the apex of the heart and the prosthetic valve is positioned within the native mitral valve.
  • the prosthetic valve is mounted in a radially compressed state along the distal end portion of a delivery apparatus.
  • the prosthetic valve and the distal end portion of the delivery apparatus are inserted into a femoral vein and are advanced into and through the inferior vena cava, and into the right atrium, and the prosthetic valve is positioned within the native tricuspid valve.
  • a similar approach can be used for implanting the prosthetic valve within the native pulmonary valve or the pulmonary artery, except that the prosthetic valve is advanced through the native tricuspid valve into the right ventricle and toward the pulmonary valve/pulmonary artery.
  • Another delivery approach is a transatrial approach whereby a prosthetic valve (on the distal end portion of the delivery apparatus) is inserted through an incision in the chest and an incision made through an atrial wall (of the right or left atrium) for accessing any of the native heart valves. Atrial delivery can also be made intravascularly, such as from a pulmonary vein. Still another delivery approach is a transventricular approach whereby a prosthetic valve (on the distal end portion of the delivery apparatus) is inserted through an incision in the chest and an incision made through the wall of the right ventricle (typically at or near the base of the heart) for implanting the prosthetic valve within the native tricuspid valve, the native pulmonary valve, or the pulmonary artery.
  • the delivery apparatus can optionally be advanced over a guidewire previously inserted into a patient’s vasculature.
  • the disclosed delivery approaches are not intended to be limited. Any of the prosthetic valves disclosed herein can be implanted using any of various delivery procedures and delivery devices known in the art. Additional Examples of the Disclosed Technology
  • a delivery system for delivering a prosthetic valve through vasculature of a patient can comprise: a handle, a shaft, a balloon, and a valve positioning structure.
  • the shaft can be coupled to the handle.
  • the balloon can be coupled to a distal end portion of the shaft.
  • the balloon can be configured to be inflated from a first, deflated state to a second, radially expanded, inflated state.
  • the balloon can include a valve mounting portion for mounting the prosthetic valve in a radially compressed state.
  • the valve positioning structure can extend at least partially over an exterior surface of the balloon, which can have a first end portion and a second end portion.
  • the valve positioning structure can be configured to radially expand from a radially collapsed state to a radially expanded state when the balloon is inflated and then resiliently radially collapse from the radially expanded state to the radially collapsed state when the balloon is deflated.
  • Example 2 The delivery system of any example herein, particularly Example 1, wherein the valve positioning structure can comprise a frame constructed of a shape-memory material, wherein the frame can be shape set in the radially collapsed configuration.
  • Example 3 The delivery system of any example herein, particularly Example 2, wherein the shape-memory material can be Nitinol.
  • Example 4 The delivery system of any example herein, particularly any one of Examples 1-3, wherein the valve positioning structure can extend around the exterior surface of the balloon at the first end portion.
  • Example 5 The delivery system of any example herein, particularly Example 4, wherein the first end portion can be a distal end portion of the balloon.
  • Example 6 The delivery system of any example herein, particularly Example 4, wherein the first end portion can be a proximal end portion of the balloon.
  • Example 7 The delivery system of any example herein, particularly Example 4, wherein the valve positioning structure can extend around the exterior surface of the balloon at both the first end portion and the second end portion of the balloon.
  • Example 8 The delivery system of any example herein, particularly any one of Examples 1-7, wherein the valve positioning structure can comprise a proximal valve positioning portion, a distal valve positioning portion, and an intermediate valve positioning portion disposed between the proximal and distal valve positioning portions.
  • Example 9 The delivery system of any example herein, particularly Example 8, wherein the proximal valve positioning portion of the valve positioning structure can be coupled to the shaft.
  • Example 10 The delivery system of any example herein, particularly Example 8, wherein the proximal valve positioning portion can be coupled to an inner surface of the shaft.
  • Example 11 The delivery system of any example herein, particularly Example 8, wherein the proximal valve positioning portion can be coupled to an outer surface of the shaft.
  • Example 13 The delivery system of any example herein, particularly any one of Examples 8-12, wherein the intermediate valve positioning portion can be configured to receive the prosthetic valve.
  • Example 14 The delivery system of any example herein, particularly any one of Examples 8-13, wherein the distal valve positioning portion can have an outer diameter that is greater than an outer diameter of the intermediate valve positioning portion.
  • Example 15 The delivery system of any example herein, particularly any one of Examples 8-14, wherein the proximal valve positioning portion can have an outer diameter that is greater than an outer diameter of the intermediate valve positioning portion.
  • Example 16 The delivery system of any example herein, particularly any one of Examples 8-15, wherein the distal valve positioning portion can taper in diameter in a direction from the intermediate valve positioning portion to a distal end of the valve positioning structure.
  • Example 17 The delivery system of any example herein, particularly any one of Examples 8-16, wherein the proximal valve positioning portion can taper in diameter in a direction from the intermediate valve positioning portion to a proximal end of the valve positioning structure.
  • Example 18 The delivery system of any example herein, particularly any one of Examples 8-17, wherein the distal valve positioning portion can have a frustoconical shape.
  • Example 19 The delivery system of any example herein, particularly any one of Examples 8-18, wherein the proximal valve positioning portion can have a frustoconical shape.
  • Example 20 The delivery system of any example herein, particularly any one of Examples 8-19, wherein the distal valve positioning portion can comprise a plurality of struts.
  • Example 21 The delivery system of any example herein, particularly Example 20, wherein the plurality of struts can include a first plurality of struts arranged in a first row that extends in a circumferential direction of the delivery system and a second plurality of struts arranged in a second row that extends in the circumferential direction.
  • Example 22 The delivery system of any example herein, particularly Example 21, wherein each one of the first plurality of struts can be a linear strut oriented at an angle relative to an axial direction of the delivery system.
  • Example 23 The delivery system of any example herein, particularly Example 22, wherein each one of the first plurality of struts can be a linear strut oriented in an axial direction of the delivery system.
  • Example 24 The delivery system of any example herein, particularly any one of Examples 21-23, wherein each one of the second plurality of struts can be a serpentine strut.
  • Example 25 The delivery system of any example herein, particularly Example 24, wherein the serpentine strut can form a plurality of semicircular turns.
  • Example 26 The delivery system of any example herein, particularly Example 24, wherein the serpentine strut can form a plurality of curves that each extend less than 180 degrees.
  • Example 27 The delivery system of any example herein, particularly any one of Examples 21-26, wherein each one of the second plurality of struts can be a zigzag strut.
  • Example 28 The delivery system of any example herein, particularly any one of Examples 8-27, wherein the proximal valve positioning portion can comprise a plurality of struts.
  • Example 29 The delivery system of any example herein, particularly Example 28, wherein the plurality of struts can include a first plurality of struts arranged in a first row that can extend in a circumferential direction of the delivery system and a second plurality of struts that can be arranged in a second row that can extend in the circumferential direction.
  • Example 30 The delivery system of any example herein, particularly Example 29, wherein each one of the first plurality of struts can be a linear strut oriented at an angle relative to an axial direction of the delivery system.
  • Example 31 The delivery system of any example herein, particularly any one of Examples 29-30, wherein each one of the second plurality of struts can be a serpentine strut.
  • Example 32 The delivery system of any example herein, particularly Example 31, wherein the serpentine strut can form a plurality of semicircular turns.
  • Example 33 The delivery system of any example herein, particularly Example 31, wherein the serpentine strut can form a plurality of curves that each extend less than 180 degrees.
  • Example 34 The delivery system of any example herein, particularly any one of Examples 29-30, wherein each one of the second plurality of struts can be a zigzag strut.
  • Example 35 The delivery system of any example herein, particularly any one of Examples 8-34, wherein the intermediate valve positioning portion can comprise a plurality of axial connecting struts that connect the distal valve positioning portion and the proximal valve positioning portion.
  • Example 36 The delivery system of any example herein, particularly any one of Examples 1-35, wherein the balloon can have an axial length in a range from 45 mm to 51 mm.
  • Example 37 The delivery system of any example herein, particularly Example 36, wherein the balloon can have an axial length in a range from 46 mm to 50 mm.
  • Example 38 The delivery system of any example herein, particularly any one of Examples 1-35, wherein the balloon can have an axial length in a range from 31 mm to 45 mm.
  • Example 39 The delivery system of any example herein, particularly Example 38, wherein the balloon can have an axial length in a range from 31 mm to 36 mm.
  • Example 40 The delivery system of any example herein, particularly any one of Examples 1-35, wherein the balloon can have an axial length in a range from 25 mm to 31 mm.
  • Example 41 The delivery system of any example herein, particularly Example 40, wherein the balloon can have an axial length in a range from 26 mm to 30 mm.
  • Example 42 The delivery system of any example herein, particularly any one of Examples 1-19, wherein the frame can comprise a braided mesh structure.
  • Example 43 The delivery system of any example herein, particularly any one of Examples 1-42, wherein the valve positioning structure can prevent the prosthetic valve from contacting the balloon.
  • Example 44 The delivery system of any example herein, particularly any one of Examples 1-43, wherein the valve positioning structure can be configured such that it does not overlap an outer surface of the prosthetic valve.
  • Example 45 The delivery system of any example herein, particularly any one of Examples 1-44, wherein the valve positioning structure can comprise a polymeric coating attached to the frame.
  • Example 46 The delivery system of any example herein, particularly Example 45, wherein the polymeric coating can be disposed on an inner surface of the frame.
  • Example 47 The delivery system of any example herein, particularly Example 45, wherein the polymeric coating can be disposed on an outer surface of the frame.
  • Example 48 The delivery system of any example herein, particularly Example 45, wherein the polymeric coating can encapsulate the frame.
  • Example 49 The delivery system of any example herein, particularly any one of Examples 1-48, wherein the valve positioning structure can be not attached to the exterior surface of the balloon.
  • Example 50 The delivery system of any example herein, particularly any one of Examples 1-49, which can further comprise the prosthetic valve, wherein the prosthetic valve can be mounted over the valve mounting portion of the balloon.
  • a delivery apparatus for delivering a prosthetic valve through vasculature of a patient can comprise: a handle, a balloon catheter, and a first valve positioning structure.
  • the balloon catheter can comprise a shaft coupled to the handle and a balloon connected to a distal end portion of the shaft.
  • the balloon can be configured to be inflated from an uninflated state to an inflated state.
  • the first valve positioning structure can extend over an exterior surface of the balloon.
  • the first valve positioning structure can comprise a first frame constructed of a shape-memory material. The first frame can be shape set in a radially compressed configuration.
  • Example 52 The delivery apparatus of any example herein, particularly Example 51 , wherein the first valve positioning structure can comprise a distal end and a proximal end, wherein an outer diameter of the first valve positioning structure at the distal end can be smaller than an outer diameter of the first valve positioning structure at a location between the distal end and the proximal end when the first valve positioning structure is in the radially compressed configuration.
  • Example 53 The delivery apparatus of any example herein, particularly any one of Examples 51-52, can further comprise a second valve positioning structure extending over the exterior surface of the balloon, wherein: the second valve positioning structure can comprise a second frame constructed of the shape-memory material, the second frame can be shape set in a radially compressed configuration, and the first valve positioning structure and the second valve positioning structure can be configured to expand to a radially expanded state when the balloon is in the inflated state.
  • Example 54 The delivery apparatus of any example herein, particularly Example 53, wherein each one of the first frame and the second frame can comprise a plurality of interconnected struts defining a plurality of cells.
  • Example 55 The delivery apparatus of any example herein, particularly any one of Examples 53-54, wherein the first valve positioning structure and the second valve positioning structure can be spaced apart in an axial direction of the delivery apparatus and can define a valve mounting portion of the delivery apparatus configured to receive the prosthetic valve.
  • Example 56 The delivery apparatus of any example herein, particularly Example 55, wherein the first valve positioning structure can be distally disposed relative to the second valve positioning structure.
  • Example 57 The delivery apparatus of any example herein, particularly any one of Examples 55-56, which can further comprise the prosthetic valve, wherein the prosthetic valve can be mounted over a valve mounting portion of the balloon.
  • Example 58 The delivery apparatus of any example herein, particularly Example 57, wherein neither the first valve positioning structure nor the second valve positioning structure can extend over an outer surface of the prosthetic valve when the prosthetic valve is mounted over the valve mounting portion.
  • Example 59 The delivery apparatus of any example herein, particularly any one of Examples 57-58, wherein the valve mounting portion can be disposed between the first and second valve positioning structures.
  • Example 60 The delivery apparatus of any example herein, particularly any one of Examples 57-59, wherein an outer diameter of the first valve positioning structure in the radially compressed configuration can be greater than an outer diameter of the prosthetic valve in a radially compressed configuration.
  • Example 61 The delivery apparatus of any example herein, particularly Example 60, wherein an outer diameter of the second valve positioning structure in the radially compressed configuration can be greater than an outer diameter of the prosthetic valve in the radially compressed configuration.
  • Example 62 The delivery apparatus of any example herein, particularly any one of Examples 53-61, wherein at least one of the first valve positioning structure and the second valve positioning structure can comprise Nitinol.
  • Example 63 The delivery apparatus of any example herein, particularly any one of Examples 53-62, which can further comprise at least one tether comprising a first end connected to the first valve positioning structure and a second end connected to the second valve positioning structure.
  • Example 64 The delivery apparatus of any example herein, particularly any one of Examples 51-62, which can further comprise at least one tether connected to the first valve positioning structure.
  • a delivery system for delivering a prosthetic valve through vasculature of a patient can comprise: a radially expandable prosthetic valve and a delivery apparatus.
  • the delivery apparatus can comprise: a handle, a shaft, an expandable distal valve positioning structure, and an expandable proximal valve positioning structure.
  • the shaft can be coupled to the handle and a balloon coupled to a distal end portion of the shaft.
  • the balloon can be configured to be inflated from a first, deflated state to a second, radially expanded, inflated state.
  • the prosthetic valve can be mounted on the balloon in a radially compressed state.
  • the expandable distal valve positioning structure can be disposed on an exterior surface of a distal end portion of the balloon.
  • the expandable proximal valve positioning structure can be disposed on an exterior surface of a proximal end portion of the balloon.
  • the distal and proximal valve positioning structures can be configured to radially expand from a radially collapsed state to a radially expanded state when the balloon is inflated and then radially collapse from the radially expanded state to the radially collapsed state when the balloon is deflated.
  • Example 66 The delivery system of any example herein, particularly Example 65, wherein the delivery apparatus can further comprise at least one tether connected to the distal valve positioning structure.
  • Example 67 The delivery system of any example herein, particularly Example 66, wherein the at least one tether can be configured to cause the distal valve positioning structure to further radially collapse when the distal valve positioning structure is in the radially collapsed state and tension is increased in the tether.
  • Example 68 The delivery apparatus of any example herein, particularly any one of Examples 66-67, wherein an intermediate portion of the at least one tether can be looped around a portion of the distal valve positioning structure.
  • Example 69 The delivery apparatus of any example herein, particularly any one of Examples 66-67, wherein the at least one tether can include a distal end portion that terminates in a loop secured to portion of the distal valve positioning structure.
  • Example 70 The delivery apparatus of any example herein, particularly any one of Examples 66-69, wherein the at least one tether can extend through a lumen of the shaft and along an outer surface of the balloon.
  • Example 71 The delivery apparatus of any example herein, particularly Example 66, wherein the distal valve positioning structure is connected to a first end of the at least one tether, and the proximal valve positioning structure is connected to a second end of the at least one tether.
  • a delivery system for delivering a prosthetic valve through vasculature of a patient can comprise: a radially expandable prosthetic valve and a delivery apparatus.
  • the delivery apparatus can comprise: a handle, a shaft, and an expandable valve positioning structure.
  • the shaft can be coupled to the handle and a balloon coupled to a distal end portion of the shaft.
  • the balloon can be configured to be inflated from a first, deflated state to a second, radially expanded, inflated state.
  • the prosthetic valve can be mounted on the balloon in a radially compressed state.
  • the expandable valve positioning structure can be disposed on an exterior surface of a portion of the balloon.
  • the valve positioning structure can be configured to radially expand from a radially collapsed state to a radially expanded state when the balloon is inflated and then resiliently radially collapse from the radially expanded state to the radially collapsed state when the balloon is deflated.
  • Example 73 The delivery system of any example herein, particularly Example 72, wherein the valve positioning structure can be constructed of a shape-memory material.
  • Example 74 The delivery system of any example herein, particularly Example 73, wherein the valve positioning structure can be shape set into the radially collapsed state.
  • Example 75 The delivery system of any example herein, particularly any one of Examples 72-74, wherein the expandable valve positioning structure can comprise a frame that includes a distal valve positioning portion, a proximal valve positioning portion, and an intermediate valve positioning portion disposed between the distal valve positioning portion and the proximal valve positioning portion.
  • Example 76 The delivery system of any example herein, particularly Example 75, wherein each of the distal valve positioning portion and the proximal valve positioning portion can have an outer diameter, and wherein each of the outer diameters of the distal valve positioning portion and the proximal valve positioning portion are greater than an outer diameter of the intermediate valve positioning portion when the valve positioning structure is in the radially collapsed state.
  • Example 77 The delivery system of any example herein, particularly any one of Examples 75-76, wherein each of the distal valve positioning portion and the proximal valve positioning portion can have an outer diameter, and wherein each of the outer diameters of the distal valve positioning portion and the proximal valve positioning portion can be greater than an outer diameter of the intermediate valve positioning portion when the valve positioning structure is in a partially radially expanded state between the radially collapsed state and the radially expanded state.
  • Example 78 Example 78.
  • each of the distal valve positioning portion, the proximal valve positioning portion, and the intermediate valve positioning portion can have an outer diameter, and wherein the outer diameters can be equal when the valve positioning structure is in the radially expanded state.
  • Example 79 The delivery system of any example herein, particularly any one of Examples 75-78, wherein the distal valve positioning portion can comprise a plurality of struts.
  • Example 80 The delivery system of any example herein, particularly Example 79, wherein the plurality of struts can include a first plurality of struts arranged in a first row that can extend in a circumferential direction of the delivery system and a second plurality of struts arranged in a second row that can extend in the circumferential direction.
  • Example 82 The delivery system of any example herein, particularly Example 80, wherein each one of the first plurality of struts can be a linear strut oriented at an angle relative to an axial direction of the delivery system.
  • Example 82 The delivery system of any example herein, particularly Example 80, wherein each one of the first plurality of struts can be a linear strut oriented in an axial direction of the delivery system.
  • Example 83 The delivery system of any example herein, particularly any one of Examples 80-82, wherein each one of the second plurality of struts can be a serpentine strut.
  • Example 84 The delivery system of any example herein, particularly Example 83, wherein the serpentine strut can form a plurality of semicircular turns.
  • Example 85 The delivery system of any example herein, particularly Example 83, wherein the serpentine strut can form a plurality of curves that each extend less than 180 degrees.
  • Example 86 The delivery system of any example herein, particularly any one of Examples 80-82, wherein each one of the second plurality of struts can be a zigzag strut.
  • Example 87 The delivery system of any example herein, particularly any one of Examples 80-86, wherein the proximal valve positioning portion can comprise a plurality of struts.
  • Example 88 The delivery system of any example herein, particularly Example 87, wherein the plurality of struts can include a first plurality of struts arranged in a first row that can extend in a circumferential direction of the delivery apparatus and a second plurality of struts arranged in a second row that can extend in the circumferential direction.
  • Example 89 The delivery system of any example herein, particularly Example 88, wherein each one of the first plurality of struts can be a linear strut oriented at an angle relative to an axial direction of the delivery apparatus.
  • Example 90 The delivery system of any example herein, particularly any one of Examples 88-89, wherein each one of the second plurality of struts can be a serpentine strut.
  • Example 91 The delivery system of any example herein, particularly Example 90, wherein the serpentine strut can form a plurality of semicircular turns.
  • Example 92 The delivery system of any example herein, particularly Example 90, wherein the serpentine strut can form a plurality of curves that each extend less than 180 degrees.
  • Example 93 The delivery system of any example herein, particularly any one of Examples 88-89, wherein each one of the second plurality of struts can be a zigzag strut.
  • Example 94 The delivery system of any example herein, particularly any one of Examples 75-93, wherein the intermediate valve positioning portion can comprise a plurality of axial connecting struts that connect the distal valve positioning portion and the proximal valve positioning portion.
  • Example 95 The delivery system of any example herein, particularly any one of Examples 72-94, wherein the balloon can have an axial length in a range from 45 mm to 51 mm.
  • Example 96 The delivery system of any example herein, particularly Example 95, wherein the balloon can have an axial length in a range from 46 mm to 50 mm.
  • Example 97 The delivery system of any example herein, particularly any one of Examples 72-94, wherein the balloon can have an axial length in a range from 31 mm to 45 mm.
  • Example 98 The delivery system of any example herein, particularly Example 97, wherein the balloon can have an axial length in a range from 31 mm to 36 mm.
  • Example 99 The delivery system of any example herein, particularly any one of Examples 72-94, wherein the balloon can have an axial length in a range from 25 mm to 31 mm.
  • Example 100 The delivery system of any example herein, particularly Example 99, wherein the balloon can have an axial length in a range from 26 mm to 30 mm.
  • a delivery apparatus for delivering a prosthetic valve through vasculature of a patient can comprise: a handle, a shaft, a balloon, and a valve positioning system.
  • the shaft can be coupled to the handle.
  • the balloon can be coupled to a distal end portion of the shaft.
  • the balloon can be configured to be inflated from a first, deflated state to a second, radially expanded, inflated state.
  • the balloon can have a proximal end portion, a distal end portion, and a valve mounting portion disposed between the proximal and distal end portions for mounting the prosthetic valve in a radially compressed state.
  • the valve positioning structure can comprise a frame, wherein the valve positioning structure can be positioned radially outward of the balloon, the valve positioning structure can extend over the proximal end portion of the balloon, the valve mounting portion of the balloon, and the distal end portion of the balloon, and the valve positioning structure can be configured to radially expand from a radially collapsed state to a radially expanded state when the balloon is inflated and then radially collapse from the radially expanded state to the radially collapsed state when the balloon is deflated.
  • Example 102 The delivery apparatus of any example herein, particularly Example 101, wherein the valve positioning structure can extend an entire length of the balloon.
  • Example 103 The delivery apparatus of any example herein, particularly any one of Examples 101-102, wherein the frame can comprise a shape-memory material and can be shape set in the radially collapsed state so that the frame collapses under its own resiliency when the balloon is deflated.
  • Example 104 The delivery apparatus of any example herein, particularly any one of Examples 101-103, wherein the frame can comprise a plurality of interconnected struts.
  • Example 105 The delivery apparatus of any example herein, particularly any one of Examples 101-103, wherein the frame can comprise a braided mesh structure.
  • Example 106 The delivery apparatus of any example herein, particularly any one of Examples 101-105, wherein the frame of the valve positioning structure can comprise a distal valve positioning portion, a proximal valve positioning portion, and an intermediate valve positioning portion disposed between the distal valve positioning portion and the proximal valve positioning portion.
  • Example 107 The delivery apparatus of any example herein, particularly Example 106, wherein the distal valve positioning portion can taper towards a distal end portion of the valve positioning structure.
  • Example 108 The delivery apparatus of any example herein, particularly any one of Examples 106-107, wherein the proximal valve positioning portion can taper towards a proximal end portion of the valve positioning structure.
  • Example 109 The delivery apparatus of any example herein, particularly any one of Examples 106-108, wherein: a distal end portion of the distal valve positioning portion can define a first diameter and a proximal end portion of the distal valve positioning portion defines a second diameter, and the second diameter can be greater than the first diameter.
  • Example 110 The delivery apparatus of any example herein, particularly Example
  • the intermediate valve positioning portion can define a third diameter, and the second diameter can be greater than the third diameter.
  • Example 111 The delivery apparatus of any example herein, particularly Example
  • a distal end portion of the proximal valve positioning portion can define a fourth diameter and a proximal end portion of the proximal valve positioning portion can define a fifth diameter, and the fifth diameter can be greater than the fourth diameter.
  • Example 112. The delivery apparatus of any example herein, particularly Example
  • Example 113 The delivery apparatus of any example herein, particularly Example
  • first, third, and fifth diameters can be substantially equal.
  • Example 114 The delivery apparatus of any example herein, particularly Example 106, wherein a region between the distal valve positioning portion and the intermediate valve positioning portion can be flared.
  • Example 1 15. The delivery apparatus of any example herein, particularly Example 106, wherein a region between the proximal valve positioning portion and the intermediate valve positioning portion can be flared.
  • Example 116 The delivery apparatus of any example herein, particularly any one of Examples 106-115, wherein the intermediate valve positioning portion can be cylindrical.
  • Example 117 A delivery apparatus for a prosthetic medical device can comprise a handle, a shaft, a balloon, and a valve positioning system.
  • the shaft can be coupled to the handle.
  • the balloon can be coupled to a distal end portion of the shaft.
  • the valve positioning structure can extend at least partially over an outer surface of the balloon, wherein the valve positioning structure can comprise a frame constructed of a shape-memory material.
  • Example 118 The delivery apparatus of any example herein, particularly Example 117, wherein the valve positioning structure can be not attached to the outer surface of the balloon.
  • Example 119 The delivery apparatus of any example herein, particularly any one of Examples 117-118, wherein a proximal end portion of the valve positioning structure can be fixed to the shaft.
  • Example 120 The delivery apparatus of any example herein, particularly Example 119, wherein a proximal end portion of the valve positioning structure can be fixed to an inner surface of the shaft.
  • Example 121 The delivery apparatus of any example herein, particularly Example 119, wherein a proximal end portion of the valve positioning structure can be fixed to an outer surface of the shaft.
  • Example 122 The delivery apparatus of any example herein, particularly any one of Examples 117-121, wherein the delivery apparatus can further comprise a nose cone distally disposed relative to the balloon and the valve positioning structure.
  • Example 123 The delivery apparatus of any example herein, particularly Example 122, wherein a distal end portion of the valve positioning structure can be fixed to the nose cone.
  • Example 124 The delivery apparatus of any example herein, particularly any one of Examples 117-123, wherein the valve positioning structure can be expandable from a radially collapsed state to a radially expanded state when the balloon is inflated to an inflated state.
  • Example 125 The delivery apparatus of any example herein, particularly Example 124, wherein the valve positioning structure can be collapsible from the radially expanded state to the radially collapsed state when the balloon is deflated to a deflated state.
  • Example 126 The delivery apparatus of any example herein, particularly Example 125, wherein the valve positioning structure can collapse under its own resiliency from the radially expanded state to the radially collapsed state.
  • Example 127 The delivery apparatus of any example herein, particularly any one of Examples 124-126, wherein the prosthetic medical device can be configured to be mounted around the valve positioning structure.
  • Example 128 The delivery apparatus of any example herein, particularly Example 127, wherein the prosthetic medical device may not contact an outer surface of the balloon when the prosthetic medical device is mounted around the valve positioning structure when the valve positioning structure is in the radially collapsed state.
  • a delivery apparatus for a prosthetic medical device can comprise: a handle, a shaft, a balloon, and a valve positioning structure.
  • the shaft can be coupled to the handle.
  • the balloon can be coupled to a distal end portion of the shaft and can comprise an outer surface.
  • the valve positioning structure can extend at least partially over the outer surface of the balloon and can comprise a frame that includes a plurality of struts. The frame can define an axial direction and a circumferential direction.
  • Example 130 The delivery apparatus of any example herein, particularly Example
  • the plurality of struts can comprise a first plurality of struts and a second plurality of struts.
  • Example 131 The delivery apparatus of any example herein, particularly Example
  • first plurality of struts can each have a linear shape.
  • Example 132 The delivery apparatus of any example herein, particularly any one of Examples 130-131, wherein the first plurality of struts can be each oriented at an angle relative to the axial direction of the frame.
  • Example 133 The delivery apparatus of any example herein, particularly any one of Examples 130-132, wherein the first plurality of struts can be arranged into at least one row that extends in the circumferential direction of the frame.
  • Example 134 The delivery apparatus of any example herein, particularly any one of Examples 130-133, wherein adjacent ends of the first plurality of struts can point in the axial direction of the frame.
  • Example 135. The delivery apparatus of any example herein, particularly any one of Examples 130-134, wherein the plurality of second struts can each have a sawtooth shape.
  • Example 136. The delivery apparatus of any example herein, particularly any one of Examples 130-135, wherein the plurality of second struts can be arranged into at least one row that extends in the circumferential direction of the frame.
  • Example 137 The delivery apparatus of any example herein, particularly any one of Examples 130-136, wherein adjacent ends of the plurality of second struts can point in the circumferential direction of the frame.
  • Example 138 The delivery apparatus of any example herein, particularly any one of Examples 130-137, wherein the plurality of struts can further comprise a third plurality of struts.
  • Example 139 The delivery apparatus of any example herein, particularly Example 138, wherein: each one of the third plurality of struts can comprise a distal end and a proximal end, each one of the third plurality of struts can connect at its distal end to a junction of two of the first plurality of struts, and each one of the third plurality of struts can connect at its proximal end to a junction of another two of the first plurality of struts.
  • Example 140 The delivery apparatus of any example herein, particularly any one of Examples 129-139, wherein the frame of the valve positioning structure can be a unitary structure.
  • Example 141 The delivery apparatus of any example herein, particularly any one of Examples 129-140, wherein the frame of the valve positioning structure can lack fasteners.
  • Example 142 The delivery apparatus of any example herein, particularly any one of Examples 129-141, wherein the frame of the valve positioning structure can be constructed of a shape-memory material.
  • Example 143 The delivery apparatus of any example herein, particularly Example 142, wherein the frame is constructed of Nitinol.
  • Example 144 The delivery apparatus of any example herein, particularly any one of Examples 142-143, wherein the frame of the valve positioning structure can be configured to collapse from a radially expanded state to a radially collapsed state under its own resiliency.
  • Example 145 The delivery apparatus of any example herein, particularly Example 144, wherein the frame can be shape set in the radially collapsed state.
  • Example 146 The delivery apparatus of any example herein, particularly any one of Examples 129-145, wherein the frame of the valve positioning structure can define a distal valve positioning portion, a proximal valve positioning portion, and an intermediate valve positioning portion disposed between the distal and proximal valve positioning portions.
  • Example 147 The delivery apparatus of any example herein, particularly Example 146, wherein the distal valve positioning portion can flare from the intermediate valve positioning portion.
  • Example 148 The delivery apparatus of any example herein, particularly any one of Examples 144-145, wherein the distal valve positioning portion can taper towards a distal end of the frame.
  • Example 149 The delivery apparatus of any example herein, particularly any one of Examples 146-148, wherein the proximal valve positioning portion can flare from the intermediate valve positioning portion.
  • Example 150 The delivery apparatus of any example herein, particularly any one of Examples 146-149, wherein the proximal valve positioning portion can taper towards a proximal end of the frame.
  • a delivery system can comprise: a balloon, an expandable distal valve positioning structure, an expandable proximal valve positioning structure, and a prosthetic heart valve.
  • the balloon can comprise: an outer surface extending from a distal end to a proximal end of the balloon and a valve mounting portion disposed on the outer surface between the distal and proximal ends.
  • the expandable distal valve positioning structure can extend over a distal portion of the outer surface of the balloon.
  • the expandable proximal valve positioning structure can extend over a proximal portion of the outer surface of the balloon.
  • the prosthetic heart valve can be crimped around the valve mounting portion of the balloon, wherein neither the distal valve positioning structure nor the proximal valve positioning structure can overlap an outer surface of the prosthetic heart valve.
  • Example 152 The delivery system of any example herein, particularly Example 151, wherein each of the distal valve positioning structure and the proximal valve positioning structure can comprise a frame that includes a plurality of struts.
  • Example 153 The delivery system of any example herein, particularly any one of Examples 151-152, further including at least one tether coupling the distal valve positioning structure and the proximal valve positioning structure.
  • Example 154 The delivery system of any example herein, particularly Example 153, wherein the at least one tether is a single tether.
  • Example 155 The delivery system of any example herein, particularly any one of Examples 151-154, wherein the tether is threaded sequentially through a plurality of eyelets of the distal valve positioning structure and sequentially through a plurality of eyelets of the proximal valve positioning structure.
  • Example 156 The delivery system of any example herein, particularly any one of Examples 151-154, wherein the tether is threaded in an alternating pattern through a plurality of eyelets of the distal valve positioning structure and a plurality of eyelets of the proximal valve positioning structure.
  • Example 157 The delivery system of any example herein, particularly any one of Examples 151-156, wherein at least one of the distal valve positioning structure and the proximal valve positioning structure includes a notch at a junction of two of the plurality of struts, and wherein the tether is threaded through the notch.
  • Example 157 The delivery system of any example herein, particularly any one of Examples 151-156, wherein at least one of the distal valve positioning structure and the proximal valve positioning structure include an axial strut extending from a junction of two of the plurality of struts, and wherein the tether is threaded through an eyelet at an end portion of the axial strut.
  • Example 158 The delivery system of any example herein, particularly any one of Examples 151-153 or 155-157, wherein the at least one tether includes a plurality of tethers.
  • a delivery system can comprise: a balloon, an expandable distal valve positioning structure, an expandable proximal valve positioning structure, at least one tether coupling the proximal valve positioning structure to the distal valve positioning structure.
  • the balloon can comprise: an outer surface extending from a distal end to a proximal end of the balloon and a valve mounting portion disposed on the outer surface between the distal and proximal ends.
  • the expandable distal valve positioning structure can extend over a distal portion of the outer surface of the balloon.
  • the expandable proximal valve positioning structure can extend over a proximal portion of the outer surface of the balloon.
  • Example 160 The delivery system of any example herein, particularly Example 159, wherein the tether comprises a suture.
  • Example 161 The delivery system of any example herein, particularly any one of Examples 159-160, wherein the tether is coupled to the distal and proximal valve positioning structures such that an axial spacing between the distal and proximal valve positioning structures decreases when the balloon is inflated.
  • Example 162 The delivery system of any example herein, particularly any one of Examples 159-160, wherein the tether is coupled to the distal and proximal valve positioning structures such that an axial spacing between the distal and proximal valve positioning structures remains constant when the balloon is inflated.
  • Example 163 The delivery system of any example herein, particularly any one of Examples 159-162, wherein the tether extends through one or more eyelets of the distal valve positioning structure and one or more eyelets of the proximal valve positioning structure.
  • Example 164 The delivery system of any example herein, wherein the delivery system is sterilized.
  • Example 165 The delivery system of any example herein, wherein the prosthetic heart valve is sterilized.
  • any one or more of the features of expandable valve positioning structure can be combined with any one or more features of another expandable valve positioning structure.
  • any distal valve positioning portion disclosed herein can be combined with any proximal valve positioning portion disclosed herein and any intermediate valve positioning portion disclosed herein to form a valve positioning structure.
  • any one or more features of one delivery apparatus can be combined with any one or more features of another delivery apparatus.

Landscapes

  • Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Mechanical Engineering (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Abstract

Des systèmes de pose ayant des structures de positionnement de valve pour une prothèse valvulaire cardiaque sont divulgués. À titre d'exemple, un système de pose peut comprendre une poignée, un cathéter à ballonnet comprenant un arbre accouplé à la poignée et un ballonnet relié à une partie d'extrémité distale de l'arbre, le ballonnet étant conçu pour être radialement extensible d'une première configuration à une seconde configuration radialement expansée; et une structure de positionnement de soupape accouplée à une surface extérieure du ballonnet ayant une première extrémité et une seconde extrémité, la structure de positionnement de soupape définissant partiellement une partie de montage de soupape du système de distribution, la structure de positionnement de soupape étant conçue pour se dilater lorsque le ballonnet est radialement expansé de la première à la seconde configuration radialement expansée.
PCT/US2025/012715 2024-01-24 2025-01-23 Système de pose de prothèse valvulaire cardiaque Pending WO2025160254A1 (fr)

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US202463624700P 2024-01-24 2024-01-24
US63/624,700 2024-01-24

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Citations (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20020077690A1 (en) * 2000-12-18 2002-06-20 Lixiao Wang Catheter for controlled stent delivery
US6730118B2 (en) 2001-10-11 2004-05-04 Percutaneous Valve Technologies, Inc. Implantable prosthetic valve
US20130030519A1 (en) 2011-07-27 2013-01-31 Edwards Lifesciences Corporation Delivery systems for prosthetic heart valve
US9539092B2 (en) * 2005-10-18 2017-01-10 Edwards Lifesciences Corporation Heart valve delivery system with valve catheter
US20170231756A1 (en) 2016-02-05 2017-08-17 Edwards Lifesciences Corporation Devices and systems for docking a heart valve
WO2018222799A1 (fr) 2017-05-31 2018-12-06 Edwards Lifesciences Corporation Élément d'étanchéité pour une valve cardiaque prothétique
US20190000615A1 (en) 2017-06-30 2019-01-03 Edwards Lifesciences Corporation Docking stations for transcatheter valves
WO2020247907A1 (fr) 2019-06-07 2020-12-10 Edwards Lifesciences Corporation Systèmes, dispositifs et procédés de traitement de valvules cardiaques
WO2022046585A1 (fr) 2020-08-24 2022-03-03 Edwards Life Sciences Corporation Méthodes et systèmes d'alignement de commissure d'une valvule cardiaque prothétique avec une commissure d'une valvule native
US20230052963A1 (en) * 2020-10-06 2023-02-16 Venus Medtech (Hangzhou), Inc. Method and Assembly for Securing an Implantable Medical Device on a Delivery System

Patent Citations (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20020077690A1 (en) * 2000-12-18 2002-06-20 Lixiao Wang Catheter for controlled stent delivery
US6730118B2 (en) 2001-10-11 2004-05-04 Percutaneous Valve Technologies, Inc. Implantable prosthetic valve
US9539092B2 (en) * 2005-10-18 2017-01-10 Edwards Lifesciences Corporation Heart valve delivery system with valve catheter
US20130030519A1 (en) 2011-07-27 2013-01-31 Edwards Lifesciences Corporation Delivery systems for prosthetic heart valve
US9339384B2 (en) 2011-07-27 2016-05-17 Edwards Lifesciences Corporation Delivery systems for prosthetic heart valve
US20170231756A1 (en) 2016-02-05 2017-08-17 Edwards Lifesciences Corporation Devices and systems for docking a heart valve
WO2018222799A1 (fr) 2017-05-31 2018-12-06 Edwards Lifesciences Corporation Élément d'étanchéité pour une valve cardiaque prothétique
US20190000615A1 (en) 2017-06-30 2019-01-03 Edwards Lifesciences Corporation Docking stations for transcatheter valves
WO2020247907A1 (fr) 2019-06-07 2020-12-10 Edwards Lifesciences Corporation Systèmes, dispositifs et procédés de traitement de valvules cardiaques
WO2022046585A1 (fr) 2020-08-24 2022-03-03 Edwards Life Sciences Corporation Méthodes et systèmes d'alignement de commissure d'une valvule cardiaque prothétique avec une commissure d'une valvule native
US20230052963A1 (en) * 2020-10-06 2023-02-16 Venus Medtech (Hangzhou), Inc. Method and Assembly for Securing an Implantable Medical Device on a Delivery System

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