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WO2025226927A1 - Système de pose de dispositif médical prothétique - Google Patents

Système de pose de dispositif médical prothétique

Info

Publication number
WO2025226927A1
WO2025226927A1 PCT/US2025/026162 US2025026162W WO2025226927A1 WO 2025226927 A1 WO2025226927 A1 WO 2025226927A1 US 2025026162 W US2025026162 W US 2025026162W WO 2025226927 A1 WO2025226927 A1 WO 2025226927A1
Authority
WO
WIPO (PCT)
Prior art keywords
delivery apparatus
end portion
tacky
parison
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/US2025/026162
Other languages
English (en)
Inventor
Jeong Soo Lee
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 WO2025226927A1 publication Critical patent/WO2025226927A1/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
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/958—Inflatable balloons for placing stents or stent-grafts
    • 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
    • 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
    • A61F2250/0019—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 hardness, e.g. Vickers, Shore, Brinell

Definitions

  • the present disclosure relates to balloon catheters for prosthetic medical devices.
  • 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 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 self-expand to its functional size.
  • Described herein are prosthetic medical device delivery apparatuses, catheter balloons for delivery apparatuses, and methods for fabricating catheter balloons.
  • the delivery apparatuses, catheter balloons, and methods can provide for improved catheter balloons that, in some examples, can more securely retain a prosthetic medical device mounted on the catheter balloon by minimizing slippage between the prosthetic medical device and the catheter balloon.
  • the devices and methods disclosed herein can, among other things, overcome one or more of the deficiencies of typical prosthetic heart valves and their delivery apparatus.
  • a delivery apparatus can include a shaft.
  • the delivery apparatus can include an inflatable balloon coupled to a distal end portion of the shaft.
  • the inflatable balloon can have an outer surface.
  • At least a section of the outer surface can be tacky.
  • the tacky outer surface can be configured to resist, prevent, or minimize slippage of a medical relative to the inflatable balloon when the medical valve is crimped around the inflated balloon.
  • the tacky section of the outer surface can have a higher coefficient of friction with respect to a surface of the medical device than a non-tacky section of the outer surface.
  • the tacky section of the outer surface can be formed from a material having a Shore A hardness in a range from 0 to 100 or a Shore D hardness in a range from 0 to 55.
  • the tacky section of the outer surface can be at least partially coated with an adhesive.
  • the inflatable balloon can define a proximal end portion, an intermediate portion, and a distal end portion.
  • each one of the proximal end portion, the intermediate portion, and the distal end portion can define a maximum diameter.
  • the maximum diameter of the proximal end portion and the maximum diameter of the distal end portion can each be greater than the maximum diameter of the intermediate portion.
  • the delivery apparatus can lack a proximal shoulder and a distal shoulder.
  • the inflatable balloon can include an inner layer and an outer layer disposed around the inner layer. [0019] In some examples, at least a section of a radially outwards-facing surface of the outer layer can be the tacky outer surface.
  • the inner layer can be formed from a first material and the outer layer can be formed from a second material.
  • the inner layer and the outer layer can be thermally bonded.
  • a method of forming a catheter balloon can include: inserting a parison at least partially through an annular sleeve having a tacky outer surface, and expanding the parison.
  • the expanded parison can form an inner layer of the catheter balloon.
  • the annular sleeve can form an outer layer of the catheter balloon.
  • At least a section of a radially outwards-facing surface of the outer layer can be tacky.
  • inserting the parison at least partially through the annular sleeve can include aligning the annular sleeve with one of a proximal end portion and a distal end portion of the parison.
  • inserting the parison at least partially through the annular sleeve can include aligning the annular sleeve with an intermediate portion of the parison.
  • the parison can be a second parison.
  • the method can further include, prior to inserting the second parison at least partially through the annular sleeve: inflating a first parison to form a balloon having a tacky outer surface.
  • the method can further include trimming the balloon having the tacky outer surface to form the annular sleeve.
  • a delivery apparatus for implanting a medical device in a patient can include a shaft and an inflatable balloon coupled to a distal end of the shaft.
  • the inflatable balloon can have an outer surface. At least a section of the outer surface can be tacky.
  • a delivery apparatus for a prosthetic heart valve can include a handle, a shaft extending in a distal direction from the handle, and a balloon coupled to a distal end of the shaft.
  • the balloon can include an inner layer and an outer layer disposed around the inner layer.
  • the outer layer can have a radially outwards-facing surface, and at least a section of the radially outwards-facing surface can be a tacky outer surface configured to resist, prevent, or minimize slippage of the prosthetic heart valve relative to the balloon when the prosthetic heart valve is crimped around the balloon.
  • a method of forming a catheter balloon can include: inserting a parison at least partially through an annular sleeve having a tacky outer surface, and expanding the parison.
  • the expanded parison can form an inner layer of the catheter balloon.
  • the annular sleeve can form an outer layer of the catheter balloon. At least a section of a radially outwards-facing surface of the outer layer can be tacky.
  • FIG. 1 is a side view of a prosthetic heart valve, according to an example.
  • FIG. 2 is a side view of a delivery apparatus for a prosthetic heart valve, according to an example.
  • FIG. 3 is a side view of a catheter balloon for a delivery apparatus, according to an example.
  • FIG. 4 is a cross-sectional view of a catheter balloon for a delivery apparatus, according to an example.
  • FIG. 5 is a perspective view of a catheter balloon for a delivery apparatus, according to an example.
  • FIG. 6 is a cross-sectional view of a parison being expanded in a mold during a blowmolding process, according to an example.
  • FIG. 7 is a cross-sectional view of a parison being expanded in a mold during a blowmolding process, according to an example.
  • FIG. 8 is a cross-sectional view of a parison being expanded in a mold during a blowmolding process, according to an 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).
  • coefficient of friction refers to a coefficient of friction between an outer surface of a catheter balloon and a surface of a prosthetic medical device.
  • a delivery apparatus that can be used to navigate a subject’s vasculature to deliver 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.
  • 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.
  • the delivery apparatus is a balloon catheter that includes a catheter balloon.
  • the catheter balloon has an outer surface, wherein at least a section of the outer surface is a “tacky” outer surface configured to reduce slippage of a prosthetic medical device (for example, a prosthetic heart valve) crimped around or mounted to the catheter balloon.
  • a prosthetic medical device for example, a prosthetic heart valve
  • the tacky surface can have a higher coefficient of friction than a non- tacky surface of the balloon.
  • the tacky surface can be formed from a material having a Shore A hardness in a range from 0 to 100 or a Shore D hardness in a range from 0 to 55.
  • the tacky surface can comprise an adhesive.
  • 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 during delivery, and then expanded to the radially expanded state once the prosthetic valve reaches the implantation site.
  • 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.
  • FIG. 1 shows an exemplary prosthetic valve 100, according to one example.
  • 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 100 can comprise a frame 112, a valvular structure 114, an inner skirt 116, and a perivalvular outer sealing member or outer skirt 118.
  • the prosthetic valve 100 can comprise an inflow end portion 115 and an outflow end portion 119, and an intermediate portion 117 extending therebetween.
  • the valvular structure 1 14 can comprise a plurality of leaflets 140 collectively forming a leaflet structure.
  • the valvular structure 114 can comprise three leaflets 140 arranged in a tricuspid arrangement. However, there can be a greater or fewer number of leaflets 140.
  • the leaflets can be secured to one another at their adjacent sides to form commissures 122 of the valvular structure 114.
  • the lower edge of the valvular structure 114 can have an undulating, curved scalloped shape, and can be secured to the inner skirt 116 by sutures (not shown).
  • the leaflets 140 can be formed of pericardial tissue (such as bovine pericardial tissue), biocompatible synthetic materials, or other various 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 112 can be made of any of various suitable plastically-expandable materials (for example, stainless steel, etc.) or self-expanding materials (for example, Nitinol) as known in the art.
  • the frame 112 When constructed of a plastically-expandable material, the frame 112 (and thus the valve 100) can be crimped to a radially compressed state on a delivery catheter and then expanded inside a patient by an inflatable catheter balloon or equivalent expansion mechanism.
  • the frame 1 12 (and thus the valve 100) can be crimped to a radially compressed state and restrained in the compressed state by insertion into a sheath or equivalent mechanism of a delivery catheter. Once inside the body, the valve can be advanced from the delivery sheath, which allows the valve to expand to its functional size.
  • Suitable plastically-expandable materials that can be used to form the frames disclosed herein 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 112 can comprise stainless steel.
  • the frame 112 can comprise cobalt-chromium.
  • the frame 112 can comprise nickel-cobalt-chromium.
  • the frame 112 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 R3OO35 comprises 35% nickel, 35% cobalt, 20% chromium, and 10% molybdenum, by weight.
  • the inner skirt 116 and/or the outer skirt 118 can be wholly or partly formed of any suitable biological material, synthetic material (for example, any of various polymers), or combinations thereof.
  • the skirts 116, 118 can comprise a fabric having interlaced yams or fibers, such as in the form of a woven, braided, or knitted fabric.
  • the fabric can have a plush nap or pile.
  • Exemplary fabrics having a plus nap or pile include velour, velvet, velveteen, corduroy, lerrycloth, fleece, etc.
  • the skirts 116, 118 can comprise a fabric without interlaced yarns or fibers, or randomly interlaced yams or fibers, such as felt or an electrospun fabric.
  • Exemplary materials that can he used for forming such fabrics include, without limitation, polyethylene (PET), ultra-high molecular weight polyethylene (UHMWPE), polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), polyamide etc.
  • the skirts 116, 118 can comprise a non-textile or non-fabric 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 116, 118 can comprise a sponge material or foam, such as polyurethane foam.
  • the skirts 116, 118 can comprise natural tissue, such as pericardium (for example, bovine pericardium, porcine pericardium, equine pericardium, or pericardium from other sources).
  • FIG. 2 shows a delivery apparatus 200, according to one example, in the form of a balloon catheter that can be used to implant a prosthetic medical device.
  • the delivery apparatus 200 can be used to implant an expandable prosthetic heart valve (for example, the prosthetic heart valve 100 of FIG. 1 and/or any of the other prosthetic heart valves described herein).
  • the delivery apparatus 200 can be specifically adapted for use in introducing a prosthetic heart valve into a heart.
  • the delivery apparatus 200 in the illustrated example of FIG. 2 comprises a handle 202 and a steerable, outer shaft 204 extending distally from the handle 202.
  • the delivery apparatus 200 can further comprise an intermediate shaft 206 (which also may be referred to as a balloon shaft) that extends proximally from the handle 202 and distally from the handle 202, the portion extending distally from the handle 202 also extending coaxially through the outer shaft 204.
  • the delivery apparatus 200 can further comprise an inner shaft 208 extending distally from the handle 202 coaxially through the intermediate shaft 206 and the outer shaft 204 and proximally from the handle 202 coaxially through the intermediate shaft 206.
  • the outer shaft 204 and the intermediate shaft 206 can be configured to translate (for example, move) longitudinally, along a central longitudinal axis 220 of the delivery apparatus 200, relative to one another to facilitate delivery and positioning of a prosthetic heart valve at an implantation site in a patient’s body.
  • the intermediate shaft 206 can include a proximal end portion 210 that extends proximally from a proximal end of the handle 202, to an adaptor 212.
  • a rotatable knob 214 can be mounted on the proximal end portion 210 and can be configured to rotate the intermediate shaft 206 around the central longitudinal axis 220 and relative to the outer shaft 204.
  • the adaptor 212 can include a first port 238 configured to receive a guidewire therethrough and a second port 240 configured to receive fluid (for example, inflation fluid) from a fluid source.
  • the second port 240 can be fluidly coupled to an inner lumen of the intermediate shaft 206.
  • the intermediate shaft 206 can further include a distal end portion that extends distally beyond a distal end of the outer shaft 204 when a distal end of the outer shaft 204 is positioned away from an inflatable catheter balloon 218 (which also referred to herein as a “balloon”) of the delivery apparatus 200.
  • a distal end portion of the inner shaft 208 can extend distally beyond the distal end portion of the intermediate shaft 206.
  • the catheter balloon 218 can be coupled to the distal end portion of the intermediate shaft 206.
  • a distal end of the catheter balloon 218 can be coupled to a distal end of the delivery apparatus 200, such as to a nose cone 222 (as shown in FIG. 2).
  • An intermediate portion of the catheter balloon 218 can overlay a valve mounting portion 224 of a distal end portion of the delivery apparatus 200.
  • the valve mounting portion 224 and the intermediate portion of the catheter balloon 218 can be configured to receive a prosthetic heart valve in a radially compressed state.
  • a prosthetic heart valve (which can be one of the prosthetic heart valves described herein) can be mounted around the catheter balloon 218, at the valve mounting portion 224 of the delivery apparatus 200.
  • Known delivery apparatuses sometimes include proximal shoulders and distal shoulders disposed between the inner shaft 208 and the catheter balloon 218 within the proximal and distal end portions of the catheter balloon 218, respectively, and which are configured to help maintain the prosthetic heart valve 250 in a fixed position on the catheter balloon 218 during delivery through the patient’s vasculature.
  • the catheter balloon 218 and other exemplary catheter balloons described herein are configured to maintain the prosthetic heart valve 250 (or other prosthetic medical device) in the fixed position on the catheter balloon 218 without the cooperation of the proximal shoulder and/or the distal shoulder.
  • the proximal and distal shoulders can be omitted from the delivery apparatus 200 in order to beneficially reduce the radial diameter of the distal end portion of the delivery apparatus 200.
  • the delivery apparatus 200 is shown with the catheter balloon 218, it should be understood that the delivery apparatus 200 can include any catheter balloon described herein.
  • the delivery apparatus 200 can include any catheter balloon having an outer surface, wherein at least a portion of the outer surface can be “tacky.” The tacky outer surface can be configured to resist, prevent, or minimize slippage of the prosthetic heart valve relative to the balloon when the prosthetic heart valve is crimped around the balloon.
  • the delivery apparatus 200 (and others disclosed herein) lack proximal and distal shoulders, in some examples, the delivery apparatus 200 (and others disclosed herein) can utilize proximal and /or distal shoulders in combination with a balloon having a tacky outer surface.
  • the outer shaft 204 can include a distal tip portion 228 mounted on its distal end.
  • the outer shaft 204 and the intermediate shaft 206 can be translated axially relative to one another to position the distal tip portion 228 adjacent to a proximal end of the valve mounting portion 224, when the prosthetic heart valve 250 is mounted in the radially compressed state on the valve mounting portion 224 (as shown in FIG. 2) and during delivery of the prosthetic heart valve to the target implantation site.
  • the distal tip portion 228 can be configured to resist movement of the prosthetic heart valve 250 relative to the catheter balloon 218 proximally, in the axial direction, relative to the catheter balloon 218, when the distal tip portion 228 is arranged adjacent to a proximal side of the valve mounting portion 224.
  • An annular space can be defined between an outer surface of the inner shaft 208 and an inner surface of the intermediate shaft 206 and can be configured to receive fluid from a fluid source via the second port 240 of the adaptor 212.
  • 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 208 and an inner surface of the catheter balloon 218.
  • fluid from the fluid source can flow to the fluid passageway from the annular space to inflate the catheter balloon 218 and radially expand and deploy the prosthetic heart valve 250.
  • An inner lumen of the inner shaft can be configured to receive a guidewire therethrough, for navigating the distal end portion of the delivery apparatus 200 to the target implantation site.
  • the handle 202 can include a steering mechanism configured to adjust the curvature of the distal end portion of the delivery apparatus 200.
  • the handle 202 includes an adjustment member, such as the illustrated rotatable knob 260, which in turn is operatively coupled to the proximal end portion of a pull wire.
  • the pull wire can extend distally from the handle 202 through the outer shaft 204 and has a distal end portion affixed to the outer shaft 204 at or near the distal end of the outer shaft 204.
  • Rotating the knob 260 can increase or decrease the tension in the pull wire, thereby adjusting the curvature of the distal end portion of the delivery apparatus 200. Further details on steering or flex mechanisms for the delivery apparatus can be found in U.S. Patent No. 9,339,384, which is incorporated by reference herein.
  • the handle 202 can further include an adjustment mechanism 261 including an adjustment member, such as the illustrated rotatable knob 262, and an associated locking mechanism including another adjustment member, configured as a rotatable knob 278.
  • the adjustment mechanism 261 is configured to adjust the axial position of the intermediate shaft 206 relative to the outer shaft 204 (for example, for fine positioning at the implantation site). Further details on the delivery apparatus 200 can be found in PCT Publication No. WO2022/046585, which is incorporated by reference herein.
  • FIG. 3 is a side view of a catheter balloon 318 for a delivery apparatus (such as delivery apparatus 200), according to an example.
  • the catheter balloon 318 can comprise an inflatable main body 380 configured to be inflatable between a deflated state and an inflated state.
  • the main body 380 can comprise a proximal end portion 382 (which is also referred to herein as a “proximal cone portion” and/or a “proximal conical portion”), a distal end portion 386 (which is also referred to herein as a “distal cone portion” and/or a “distal conical portion”) distally disposed relative to the proximal end portion 382, and an intermediate portion 384 extending therebetween.
  • proximal end portion 382 which is also referred to herein as a “proximal cone portion” and/or a “proximal conical portion”
  • distal end portion 386 which is also referred to herein as a “distal cone portion” and/or
  • the balloon 318 can further comprise a proximal leg 372 extending proximally from the proximal end portion 382 and a distal leg 374 extending distally from the distal end portion 386.
  • the proximal leg 372 can be configured to be coupled to a shaft of a delivery apparatus (for example, the intermediate shaft 206).
  • the intermediate portion 384 which in some examples can be a working portion of the catheter balloon 318, can be configured to receive a prosthetic medical device (for example, any one of prosthetic heart valves 100, 250) in a radially compressed state.
  • the distal leg 374 can be configured to be coupled to a distal end component (for example, the nose cone 222) of a delivery apparatus.
  • the proximal leg 372, the distal leg 374, the proximal end portion 382, the intermediate portion 384, and the distal end portion 386 can be integrally formed as a single component.
  • Each one of the proximal end portion 382, the intermediate portion 384, and the distal end portion 386 can define a maximum diameter in a radial direction. As shown, the maximum diameters of the proximal end portion 382, the intermediate portion 384, and the distal end portion 386 are equal, such that the diameters of the proximal and distal end portions 382 and 386 taper from the maximum diameter of the cylindrical intermediate portion 384 towards their respective ends of the catheter balloon 318. In some examples, the maximum diameters of the proximal end portion 382, the intermediate portion 384, and the distal end portion 386 can be equal or substantially equal (for example, within 10%).
  • the proximal end portion 382 and the distal end portion 386 each have a conical or frustoconical shape.
  • the proximal end portion 382 and the distal end portion 386 can have a hemispherical or a semi-ellipsoid shape.
  • the main body 380 of the catheter balloon 318 can define an outer surface 390.
  • the outer surface 390 can be a radially outwards-facing surface of the main body 380.
  • the outer surface 390 can define different sections.
  • the outer surface 390 catheter balloon 318 can be divided into a proximal section 392 (which is also referred to herein as a “proximal outer surface” and/or a “proximal outer surface section”), an intermediate section 394 (which is also referred to herein as an “intermediate outer surface” and/or an “intermediate outer surface section”), and a distal section 396 (which is also referred to herein as a “distal outer surface” and/or a “distal outer surface section”).
  • the proximal section 392 of the outer surface 390 can be the outer surface of the proximal end portion 382.
  • the intermediate section 394 of the outer surface 390 can be the outer surface of the intermediate portion 384.
  • the distal section 396 of the outer surface 390 can be the outer surface of the distal end portion 386.
  • At least one section of the outer surface 390 can be “tacky.”
  • a tacky section or surface of a catheter balloon is configured to resist, prevent, or minimize axial and/or circumferential slippage of a prosthetic medical device (for example, any one of prosthetic heart valves 100, 250) relative to the catheter balloon when the prosthetic medical device is crimped around the catheter balloon and/or engaged with the tacky section or surface.
  • the tacky section or surface can have one or more properties or combination of properties — including any of the properties described below — that render it “tacky.”
  • a surface (or a section thereof) can be “tacky” if it is formed from a material (for example, a polymeric material) having a Shore D hardness (which is also referred to herein as a “Shore durometer”) that is less than the Shore D hardness of a material forming a non-tacky section or surface of the catheter balloon 318.
  • a tacky outer surface can be formed from a first material having a first Shore D hardness of less than 55 (for example, in a range of Shore D hardnesses from 0 to 55), and a non-tacky portion of the catheter balloon 318 can be formed from a second material having a second, higher Shore D hardness such as Pebax 72D.
  • Exemplary materials having a desirable Shore D hardness include — but are not limited to — a polyurethane, a co-polyester, a co-polyamide, and any combination thereof.
  • a surface can be tacky if it is formed from a material having a Shore A hardness of less than 100 (for example, in a range of Shore A hardnesses from 0 to 100).
  • a surface can be “tacky” if it has a higher coefficient of friction with respect to a surface of a prosthetic medical device (for example, an inner surface of any one of prosthetic heart valves 100, 250) than a non-tacky surface of the catheter balloon 318.
  • the tacky outer surface and the surface of the prosthetic medical device can define a first coefficient of friction.
  • a non-tacky surface of the catheter balloon 318 and the surface of the prosthetic medical device can define a second coefficient of friction. The first coefficient of friction can be higher than the second coefficient of friction.
  • the tacky outer surface can exert a relatively greater frictional force on the prosthetic medical device in order to better resist, prevent, or minimize movement of the prosthetic medical device relative to the catheter balloon 318.
  • coefficient of friction refers to a coefficient of friction between an outer surface of a catheter balloon and a surface of a prosthetic medical device.
  • a surface (or a section thereof) can be “tacky” if it is at least partially coated with an adhesive.
  • the adhesive can be hydrophilic or hydrophobic. Examples of the adhesive include — but are not limited to — a polyurethane-based adhesive, a silicone-based adhesive, and any combination thereof.
  • a tacky outer surface can have any combination of the aforementioned properties.
  • a tacky outer surface formed from a material having a Shore A hardness in a range from 0 to 100 or a Shore D hardness in a range from 0 to 55 can define a relatively higher coefficient of friction and/or be at least partially coated with an adhesive.
  • a tacky outer surface defining a relatively higher coefficient of friction can be at least partially coated with an adhesive.
  • any combination of sections of the outer surface 390 can be tacky.
  • each one of the proximal end section 392, the intermediate section 394, and the distal end section 396 are tacky surfaces.
  • the catheter balloon 318 has a tacky outer surface extending the entire length of the catheter balloon 318.
  • the proximal end section 392 and the distal end section 396 can be tacky outer surfaces, while the intermediate section 394 can be a non-tacky outer surface.
  • the intermediate section 394 can be a tacky outer surface, while the proximal end section 392 and the distal end section 396 can be non-tacky outer surfaces.
  • proximal end portion 382 and/or the distal end portion 386 are conical and have tacky outer surfaces, such end portions 382, 386 are also referred to as “tacky cones” and/or “tacky conical portions.”
  • FIG. 4 is a side view of a catheter balloon 418 for a delivery apparatus (such as delivery apparatus 200), according to an example.
  • the catheter balloon 418 can include an inflatable main body 480 comprising a proximal end portion 482, a distal end portion 486 distally disposed relative to the proximal end portion 482, and an intermediate portion 484 disposed therebetween.
  • Each one of the proximal end portion 482, the intermediate portion 484, and the distal end portion 486 can define a maximum diameter.
  • One exemplary difference between the presently illustrated catheter balloon 418 and the catheter balloon 318 illustrated in FIG. 3 is that the maximum diameters of the proximal end portion 482 and the distal end portion 486 are each greater than the maximum diameter of the intermediate portion 484.
  • the distal-most end portion of the proximal end portion 482 defines a diameter greater than a diameter of the cylindrical intermediate portion 484 and the proximal-most end portion of the distal end portion 486 defines a diameter greater than the diameter of the intermediate portion 484.
  • a proximal-most end portion of the prosthetic medical device can abut the distal-most end portion of the proximal end portion 482 and a distal-most end portion of the prosthetic medical device can abut the proximal-most end portion of the distal end portion 486.
  • the wider proximal and distal end portions 482, 486 can better minimize relative axial movement between the prosthetic medical device and the catheter balloon 418.
  • the main body 480 of the catheter balloon 418 can define an outer surface 490.
  • the outer surface 490 can define a proximal section 492, an intermediate section 494, and a distal section 496.
  • One exemplary difference between the presently illustrated catheter balloon 418 and the catheter balloon 318 illustrated in FIG. 3 is that the proximal section 492 and the distal section 496 are the tacky sections of the outer surface 490, while the intermediate section 494 is a non-tacky section of the outer surface 490.
  • the tacky sections of the outer surface 490 only engage the prosthetic medical device crimped around or mounted on the catheter balloon 418 if the prosthetic medical device becomes axially misaligned with the intermediate portion 484.
  • any combination of the proximal section 492, the intermediate section 494, and the distal section 496 can be the tacky sections of the outer surface 490.
  • the main body 480 of the catheter balloon 418 includes an inner surface 488.
  • the inner surface 488 can be a non-tacky surface of the catheter balloon 418.
  • the inner surface 488 and the outer surface 490 can define one or more thicknesses therebetween.
  • the proximal end portion 482 can have a first thickness 498a
  • the intermediate portion 484 can have a second thickness 498b
  • the distal end portion 486 can have a third thickness 498c.
  • the thickness 498a of the proximal end portion 482 and the thickness 498c of the distal end portion 486 can each be greater than the thickness 498b of the intermediate portion 484.
  • the thicknesses 498a, 498b, and 498c can be equal or substantially equal (for example, within 10%). In some examples, the thickness 498b of the intermediate portion 484 can be greater than the thicknesses 498a and 498c of the proximal and distal end portions 482 and 486.
  • At least a portion of the main body 480 of the catheter balloon 418 can comprise at least one layer.
  • the main body 480 can comprise an inner layer 499a and an outer layer 499b disposed around at least a portion or section of the inner layer 499a.
  • a radially inwards-facing surface of the inner layer 499a can be the inner surface 488 of the main body 480 of the catheter balloon 418.
  • a radially outwards-facing surface of the outer layer 499b can be at least a section the outer surface 490 of the main body 480 of the catheter balloon 418.
  • only the proximal and distal end portions 482 and 486 of the main body 480 include the both the inner layer 499a and the outer layer 499b (in other words, the outer layer 499b is disposed only around proximal and distal end portions of the inner layer 499a).
  • only the intermediate portion 484 of the main body 480 includes both the inner layer 499a and the outer layer 499b (in other words, the outer layer 499b is disposed only around an intermediate portion of the inner layer 499a).
  • each one of the proximal end portion 482, the intermediate portion 484, and the distal end portion 486 can include both the inner layer 499a and the outer layer 499b.
  • the outer layer 499b can be bonded (for example, thermally bonded and/or adhesively bonded) with the inner layer 499a.
  • the inner layer 499a can he formed from a first material.
  • the first material can comprise any combination of nylon, polyethylene terephthalate (PET), and a polyether block amide having a Shore D durometer greater than or equal to 70.
  • the first material can be a non-tacky material.
  • the outer layer 499b can be formed from a second, different material.
  • the second material can comprise any combination of polyurethane such as Tecoflex, Tecothane, or Pellethane from Lubrizol, a copolyester such as Hytrel from Du Pont, or a co-polyamide such as Pebax from Arkema.
  • the second material can be a tacky material.
  • the inner layer 499a and the outer layer 499b can be formed from the same material. While the inner layer 499a and the outer layer 499b are described primarily with respect to the catheter balloon 418 of FIG. 4, it should be understood that any catheter balloon described herein can comprise a main body having multiple layers.
  • FIG. 5 is a perspective view of a catheter balloon 518 for a delivery apparatus (such as delivery apparatus 200), according to an example.
  • the catheter balloon 518 can include an inflatable main body 580 comprising a proximal end portion 582, a distal end portion 586 distally disposed relative to the proximal end portion 582, and an intermediate portion 584 disposed therebetween.
  • Each one of the proximal end portion 582, the intermediate portion 584, and the distal end portion 586 can define a maximum diameter.
  • One exemplary difference between the presently illustrated catheter balloon 518 and the previously illustrated catheter balloons 318, 418 shown in FIGS. 3-4 is that the maximum diameter of the intermediate portion 584 is greater than each one of the maximum diameters of the proximal end portion 582 and the distal end portion 586.
  • the main body 580 can comprise a first, inner layer 599a and a second, outer layer 599b disposed around an intermediate portion of the inner layer 599a.
  • the first layer 599a can comprise a non-tacky material (any of those described herein) and the second layer 599b can comprise a tacky material (any of those described herein).
  • the main body 580 of the catheter balloon 518 can define an outer surface 590.
  • the outer surface 590 can define a proximal section 592, an intermediate section 594, and a distal section 596.
  • the intermediate section 594 is the tacky section of the outer surface 590, while the proximal and distal sections 592, 596 are the non-tacky sections of the outer surface 590.
  • a prosthetic medical device for example, any one of prosthetic heart valves 100, 250
  • crimped around the intermediate portion 584 can engage the tacky intermediate section 594 of the outer surface 590.
  • FIG. 6 is a cross-sectional view of a parison 680 being expanded in a mold 600 during a blow- molding process, according to an example.
  • the parison 680 can be expanded in the mold 600 to form a catheter balloon having a tacky outer surface that extends along the entire length of the catheter balloon (for example, the catheter balloon 318 of FIG. 3).
  • the parison 680 (which is also referred to herein as a “multi-layered parison”) can include a proximal portion 682, an intermediate portion 684, and a distal portion 686.
  • the parison 680 can comprise an inner layer 699a and an outer layer 699b disposed around the inner layer 699a.
  • the inner layer 699a and the outer layer 699b can be thermally bonded and/or adhesively bonded.
  • the inner layer 699a of the parison 680 can be formed from a first material and the outer layer 699b of the parison 680 can be formed from a second, different material.
  • the first material can be a non- tacky material, such as any combination of nylon, polyethylene terephthalate (PET), and polyether block amide having a Shore D durometer greater than or equal to 70.
  • the second material can be a tacky material, such as any combination of polyurethane such as Tecoflex, Tecothane, or Pellethane from Lubrizol, a co-polyester such as Hytrel from Du Pont, or a co-polyamide such as Pebax from Arkema.
  • the mold 600 can include a proximal portion 610, a distal portion 630 distally disposed relative to the proximal portion 610, and an intermediate portion 620 disposed therebetween.
  • the proximal portion 610, the intermediate portion 620, and the distal portion 630 can be formed as a unitary structure.
  • any combination of the proximal portion 610, the intermediate portion 620, and the distal portion 630 can be formed as separate components.
  • the mold 600 can be a clamshell mold.
  • the blow-molding process can include inserting the parison 680 into the mold 600 and inflating the parison 680 to form a resulting catheter balloon (for example, the catheter balloon 318 of FIG. 3).
  • the parison 680 can be inserted into the mold 600 such that the proximal portion 682 of the parison 680 aligns with the proximal portion 610 of the mold 600, the intermediate portion 684 of the parison 680 aligns with the intermediate portion 620 of the mold 600, and the distal portion 686 of the parison 680 aligns with the distal portion 620 of the mold 600.
  • the proximal portion 682 of the parison can he expanded form a proximal end portion of the catheter balloon
  • the intermediate portion 684 of the parison 680 can be expanded to form an intermediate portion of the catheter balloon
  • the distal portion 686 of the parison 680 can be expanded to form a distal end portion of the catheter balloon. Expanding the parison 680 results in a radially outwards-facing surface of the outer layer 699b forming the tacky outer surface of the resulting catheter balloon.
  • the outer surface of the catheter balloon can optionally be at least partially coated in an adhesive.
  • FIG. 7 is a cross-sectional view of a parison 780 being expanded in the mold 600 of FIG. 6 during a blow-molding process, according to an example.
  • the blow-molding process can result in a catheter balloon having tacky proximal and distal outer surfaces and a non-tacky intermediate outer surface (for example, the catheter balloon 418 of FIG. 4).
  • the blow-molding process can comprise inflating a first parison in a mold (for example, the mold 600) to form a first balloon having a tacky outer surface.
  • the first parison can comprise a tacky material, such as any combination of polyurethane such as Tecoflex, Tecothane, or Pellethane from Lubrizol, a co-polyester such as Hytrel from Du Pont, or a co-polyamide such as Pebax from Arkema.
  • the first balloon can be at least partially coated with an adhesive.
  • the adhesive can be a hydrophilic or hydrophobic adhesive.
  • the adhesive can comprise any combination of a polyurethane-based adhesive and a silicone-based adhesive.
  • the first balloon can be trimmed to form a first annular sleeve 740 and a second annular sleeve 750.
  • Each one of the first and second annular sleeves 740, 750 can have a hollow frustoconical shape.
  • the radially outwards-facing surfaces of each one of the first and second annular sleeves 740, 750 can be a tacky outer surface.
  • the first and second annular sleeves 740, 750 can be inserted into the mold 600.
  • the first annular sleeve 740 can be aligned in the mold 600 with the proximal portion 610 and the second annular sleeve 750 can be aligned in the mold 600 with the distal portion 630.
  • the parison 780 (which is also referred to herein as a “second parison’') can be a singlelayer parison comprising a non-tacky material, such as any combination of nylon, polyethylene terephthalate (PET), and poly ether block amide having a Shore D durometer equal to or greater than 70.
  • the parison 780 can be placed into the mold 600 and inserted at least partially through each one of the hollow first and second annular sleeves 740, 750. As shown, a proximal portion of the parison 780 can be aligned with the first annular sleeve 740 and a distal portion of the parison 780 can be aligned with the second annular sleeve 750.
  • the parison 780 can then be inflated in the mold 600.
  • the resulting catheter balloon (which is also referred to herein as a “second balloon”) can comprise the expanded parison 780 and the first and second annular sleeves 740 and 750, whose radially outwards-facing surfaces define tacky proximal and distal sections of the outer surface of the catheter balloon.
  • the expanded parison 780 can have a radially outwards-facing surface that defines a non-tacky intermediate section of the outer surface of the catheter balloon.
  • a radially inwards-facing surface of the inflated parison 780 can define an inner, non-tacky surface of the catheter balloon.
  • the radially outwards-facing surfaces of the first and second annular sleeves 740 and 750 can be at least partially coated with an adhesive after the second balloon is formed.
  • FIG. 8 is a cross-sectional view of the parison 780 of FIG. 7 being expanded in the mold 600 of FIGS. 6-7 during a blow-molding process, according to an example.
  • the blowmolding process can result in a catheter balloon whose outer surface has a tacky intermediate section and non-tacky proximal and distal sections (for example, the catheter balloon 518 of FIG. 5).
  • annular sleeve 860 can have a tacky outer surface.
  • the annular sleeve 860 can be inserted into the mold 600 and aligned with the intermediate portion 620 of the mold 600.
  • the parison 780 can be inserted at least partially through the annular sleeve 860, such that an intermediate portion of the parison 780 is aligned with the annular sleeve 860.
  • the parison 780 can then be inflated in the mold 600.
  • the resulting catheter balloon can comprise the expanded parison 780 and the annular sleeve 860, whose radially outwards- facing surface defines a tacky intermediate section of the outer surface of the catheter balloon.
  • a radially outwards-facing surface of the expanded parison 780 can define non-tacky proximal and distal sections of the outer surface of the catheter balloon.
  • 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.
  • a delivery apparatus for implanting a medical device in a patient can compromise a shaft and an inflatable balloon coupled to a distal end portion of the shaft.
  • the inflatable balloon can have an outer surface. At least a section of the outer surface can be tacky.
  • Example 2 The delivery apparatus of any example herein, particularly example 1, wherein the tacky section of the outer surface can have a higher coefficient of friction than a non-tacky section of the outer surface.
  • Example 3 The delivery apparatus of any example herein, particularly any one of examples 1-2, wherein the tacky section of the outer surface can be formed from a material having a Shore A hardness in a range from 0 to 100 or a Shore D hardness in a range from 0 to 55.
  • Example 4 The delivery apparatus of any example herein, particularly any one of examples 1-3, wherein the tacky section of the outer surface can be at least partially coated with an adhesive.
  • Example 5 The delivery apparatus of any example herein, particularly example 4, wherein the adhesive can be hydrophilic.
  • Example 6 The delivery apparatus of any example herein, particularly example 4, wherein the adhesive can be hydrophobic.
  • Example 7 The delivery apparatus of any example herein, particularly example 4, wherein the adhesive can be any combination of a polyurethane-based adhesive and a silicone- based adhesive.
  • Example 8 The delivery apparatus of any example herein, particularly any one of examples 1-7, wherein the inflatable balloon can define a proximal end portion, an intermediate portion, and a distal end portion, and wherein each one of the proximal end portion, the intermediate portion, and the distal end portion can define a maximum diameter.
  • Example 9 The delivery apparatus of any example herein, particularly example 8, wherein the maximum diameter of the proximal end portion and the maximum diameter of the distal end portion can each be greater than the maximum diameter of the intermediate portion.
  • Example 10 The delivery apparatus of any example herein, particularly example 8, wherein the proximal end portion, the intermediate portion, and the distal end portion can have substantially equal maximum diameters.
  • Example 11 The delivery apparatus of any example herein, particularly any one of examples 1-10, wherein the delivery apparatus can lack a proximal shoulder and a distal shoulder.
  • a delivery apparatus for a prosthetic heart valve can comprise a handle, a shaft extending in a distal direction from the handle, and a balloon coupled to a distal end of the shaft.
  • the balloon can comprise an inner layer and an outer layer disposed around the inner layer.
  • the outer layer can have a radially outwards-facing surface, and at least a section of the radially outwards-facing surface can be a tacky outer surface configured to resist slippage of the prosthetic heart valve relative to the balloon when the prosthetic heart valve is crimped around the balloon.
  • Example 13 The delivery apparatus of any example herein, particularly example 12, wherein the inner layer can be formed from a first material and the outer layer can be formed from a second material.
  • Example 14 The delivery apparatus of any example herein, particularly example 13, wherein the first material can comprise any combination of nylon, polyethylene terephthalate (PET), and a polyether block amide having a Shore D durometer greater than or equal to 70.
  • the first material can comprise any combination of nylon, polyethylene terephthalate (PET), and a polyether block amide having a Shore D durometer greater than or equal to 70.
  • Example 15 The delivery apparatus of any example herein, particularly any one of examples 13-14, wherein the second material can comprise any combination of polyurethane, a co-polyester, and a co-polyamide having a Shore A durometer in a range from 0 to 100 or having a Shore D durometer in a range from 0 to 55.
  • Example 16 The delivery apparatus of any example herein, particularly example 15, wherein polyurethane includes Tecoflex, Tecothane, and Pellethane.
  • Example 17 The delivery apparatus of any example herein, particularly any one of examples 12-16, wherein the radially outwards -facing surface of the outer layer can be at least partially coated with an adhesive.
  • Example 18 The delivery apparatus of any example herein, particularly any one of examples 12-17, wherein the inner layer and the outer layer can be thermally bonded.
  • Example 19 The delivery apparatus of any example herein, particularly any one of examples 12-18, wherein the outer layer is disposed around an intermediate portion of the inner layer.
  • Example 20 The delivery apparatus of any example herein, particularly any one of examples 12-18, wherein the outer layer is disposed around an end portion of the inner layer.
  • Example 21 The delivery apparatus of any example herein, particularly example 20, wherein the outer layer is disposed around a proximal end portion and a distal end portion of the inner layer.
  • Example 23 The delivery apparatus of any example herein, particularly any one of examples 12-21, wherein the outer layer is disposed only around a portion of the inner layer.
  • a method of forming a catheter balloon can comprise: inserting a parison at least partially through an annular sleeve having a tacky outer surface, and expanding the parison.
  • the expanded parison can form an inner layer of the catheter balloon.
  • the annular sleeve can form an outer layer of the catheter balloon. At least a section of a radially outwards- facing surface of the outer layer can be tacky.
  • Example 24 The method of any example herein, particularly example 23, wherein inserting the parison at least partially through the annular sleeve can comprise aligning the annular sleeve with one of a proximal end portion and a distal end portion of the parison.
  • Example 25 The method any example herein, particularly example 23, wherein inserting the parison at least partially through the annular sleeve can comprise aligning the annular sleeve with an intermediate portion of the parison.
  • Example 26 The method any example herein, particularly any one of examples 23- 25, wherein the parison can be a second parison.
  • the method can further comprise, prior to inserting the second parison at least partially through the annular sleeve: inflating a first parison to form a balloon having a tacky outer surface; and trimming the balloon having the tacky outer surface to form the annular sleeve.
  • Example 27 The catheter balloon of any example herein, wherein the catheter balloon is sterilized.
  • any one or more of the features of one catheter balloon can be combined with any one or more features of another locking mechanism.
  • 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)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (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

Selon l'invention, un appareil de pose pour implanter un dispositif médical chez un patient peut comprendre un arbre et un ballonnet gonflable relié à une partie d'extrémité distale de l'arbre. Le ballonnet gonflable peut comporter une surface externe, au moins une section de la surface externe pouvant être collante. La section collante de la surface externe peut être conçue pour empêcher le glissement de la valve médicale par rapport au ballonnet gonflable lorsque la valve médicale est sertie autour du ballonnet gonflable.
PCT/US2025/026162 2024-04-25 2025-04-24 Système de pose de dispositif médical prothétique Pending WO2025226927A1 (fr)

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US202463638519P 2024-04-25 2024-04-25
US63/638,519 2024-04-25

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Citations (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6730118B2 (en) 2001-10-11 2004-05-04 Percutaneous Valve Technologies, Inc. Implantable prosthetic valve
US20040098078A1 (en) * 1994-06-06 2004-05-20 Scimed Life Systems, Inc. Balloon with reinforcement and/or expansion control fibers
US20080065188A1 (en) * 2006-09-12 2008-03-13 Boston Scientific Scimed, Inc. Multilayer balloon for bifurcated stent delivery and methods of making and using the same
US20130172817A1 (en) * 2005-12-20 2013-07-04 Abbott Cardiovascular Systems Inc. Non-compliant multilayered balloon for a catheter
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
US20190000615A1 (en) 2017-06-30 2019-01-03 Edwards Lifesciences Corporation Docking stations for transcatheter valves
US20200383780A1 (en) * 2019-06-07 2020-12-10 Medtronic, Inc. Balloon expandable transcatheter valve deployment devices and methods
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

Patent Citations (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040098078A1 (en) * 1994-06-06 2004-05-20 Scimed Life Systems, Inc. Balloon with reinforcement and/or expansion control fibers
US6730118B2 (en) 2001-10-11 2004-05-04 Percutaneous Valve Technologies, Inc. Implantable prosthetic valve
US20130172817A1 (en) * 2005-12-20 2013-07-04 Abbott Cardiovascular Systems Inc. Non-compliant multilayered balloon for a catheter
US20080065188A1 (en) * 2006-09-12 2008-03-13 Boston Scientific Scimed, Inc. Multilayer balloon for bifurcated stent delivery and methods of making and using the same
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
US20190000615A1 (en) 2017-06-30 2019-01-03 Edwards Lifesciences Corporation Docking stations for transcatheter valves
US20200383780A1 (en) * 2019-06-07 2020-12-10 Medtronic, Inc. Balloon expandable transcatheter valve deployment devices and methods
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

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