[go: up one dir, main page]

WO2025151823A1 - Ensembles de fixation de prothèse valvulaire et méthodes associées - Google Patents

Ensembles de fixation de prothèse valvulaire et méthodes associées

Info

Publication number
WO2025151823A1
WO2025151823A1 PCT/US2025/011246 US2025011246W WO2025151823A1 WO 2025151823 A1 WO2025151823 A1 WO 2025151823A1 US 2025011246 W US2025011246 W US 2025011246W WO 2025151823 A1 WO2025151823 A1 WO 2025151823A1
Authority
WO
WIPO (PCT)
Prior art keywords
valve
support body
implantable prosthetic
crimping device
prosthetic valve
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/US2025/011246
Other languages
English (en)
Inventor
Duc Hong NGUYEN
Jennifer Marie REITMAJER
Elizabeth Anne ANDERSON
Michael C. MURAD
Rachel Hsin-lan LIN
Quang Ngoc VU
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 WO2025151823A1 publication Critical patent/WO2025151823A1/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
    • A61F2/9522—Means for mounting a stent or stent-graft onto or into a placement instrument
    • A61F2/9524—Iris-type crimpers

Definitions

  • the present disclosure relates to prosthetic valve mounting assemblies and associated methods, and more particularly to assemblies and methods that utilize a valve crimping device for crimping an implantable prosthetic valve onto a delivery apparatus.
  • 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.
  • implantable prosthetic valves Described herein are implantable prosthetic valves, delivery apparatus, mounting assemblies, and methods for mounting the implantable prosthetic valves the delivery apparatus.
  • the disclosed implantable prosthetic valves, delivery apparatus, mounting assemblies, and methods can, for example, facilitate crimping the implantable prosthetic valve onto the delivery apparatus in a simple and precisely repeatable manner.
  • a valve crimping device can comprise a handle configured to be manually actuated to crimp an implantable prosthetic valve around a valve delivery apparatus and a crimp brake mechanism configured to at least partially retain the handle in an intermediate position. When the handle is in the intermediate position, the valve crimping device is configured to support the implantable prosthetic valve in a partially crimped configuration.
  • a valve crimping device can further comprise one or more of the components described herein.
  • a valve crimping device comprises a base, a rotatable body mounted to the base and defining a central axis, and a plurality of pressing surfaces surrounding the central axis and collectively defining a channel.
  • the handle is configured to rotate the rotatable body relative to the base, and the pressing surfaces are radially movable within the rotatable body toward and away from the central axis as the rotatable body rotates relative to the base such that a channel diameter of the channel varies as the pressing surfaces move toward and away from the central axis.
  • the crimp brake mechanism restricts the rotatable body from rotating relative to the base.
  • the crimp brake mechanism is configured such that, when the catch unit is removed from the crimp stop and the rotatable body is in a crimped configuration, the handle engages the crimp stop to restrict the handle from rotating the rotatable body to further decrease the channel diameter.
  • valve crimping device when the valve crimping device is in an intermediate configuration, the valve crimping device engages the implantable prosthetic valve in a partially crimped configuration.
  • a mounting assembly is configured such that, when the valve crimping device is in the intermediate configuration, the support body may be removed from the valve crimping device while the implantable prosthetic valve is supported within the channel by the valve crimping device.
  • a prosthetic valve preparation assembly can comprise an implantable prosthetic valve, a valve delivery apparatus, and a valve crimping device for crimping the implantable prosthetic valve around a portion of the valve delivery apparatus.
  • a prosthetic valve preparation assembly can further comprise one or more of the components disclosed herein.
  • the valve delivery apparatus is configured to deliver the implantable prosthetic valve through a patient’ s vasculature to a target implantation site.
  • the valve delivery apparatus comprises a steerable guide catheter, a balloon catheter extending through the guide catheter, and an inflatable balloon mounted to the balloon catheter.
  • a prosthetic valve preparation assembly comprises one or more of the components recited in examples 60-69 below.
  • a method of mounting an implantable prosthetic valve to a valve delivery apparatus can comprise, with a valve crimping device in an open configuration, operatively coupling a support body on which the implantable prosthetic valve is mounted to a proximal side portion of the valve crimping device to position the implantable prosthetic valve within a channel of the valve crimping device.
  • the method further can comprise transitioning the valve crimping device to an intermediate configuration and removing the support body from the valve crimping device.
  • a method can further comprise one or more of the steps disclosed herein.
  • a method further comprises operatively coupling a positioning device to the valve crimping device, mounting the valve delivery apparatus to the positioning device to position the valve delivery apparatus within the channel, and transitioning the valve crimping device to a crimped configuration.
  • the operatively coupling the positioning device to the proximal side portion is performed subsequent to the removing the support body from the valve crimping device.
  • retaining the valve crimping device in the intermediate configuration comprises activating a crimp brake mechanism of the valve crimping device.
  • a method comprises one or more of the steps recited in examples 70-117 below.
  • FIG. 5 is a perspective view of a support body of a mounting assembly according to an example.
  • FIG. 6 is a perspective view of a ring body of a mounting assembly according to an example.
  • FIG. 7 is a perspective view of the ring body of FIG. 6 operatively coupled to the support body of FIG. 5 according to an example.
  • FIG. 8 is a perspective view of a positioning device of a mounting assembly according to an example.
  • FIG. 10A is a perspective view of a valve crimping device in an open configuration according to an example, with the catch unit of FIG. 2 and the crimp stop of FIG. 3 operatively coupled to the valve crimping device.
  • FIG. 10B is a perspective view of the valve crimping device of FIG. 10A with a handle of the valve crimping device actuated in a first direction according to an example.
  • FIG. 10C is a perspective view of the valve crimping device of FIGS. 10A-10B in an intermediate configuration according to an example.
  • FIG. 10D is a perspective view of the valve crimping device of FIGS. 10A-10C in a crimped configuration and with the catch unit removed from the crimp brake according to an example.
  • FIG. 1 IB is a schematic cross-sectional front view of the valve crimping device of FIG. 10B, as viewed along the line 11B-11B in FIG. 10B, with pressing surfaces of the valve crimping device in contact with the implantable prosthetic valve according to an example.
  • FIG. 11C is a schematic cross-sectional front view of the valve crimping device of FIG. 10C, as viewed along the line 11C-11C in FIG. 10C, in the intermediate configuration and with a positioning device supporting a valve delivery apparatus within the channel of the valve crimping device according to an example.
  • FIG. 1 ID is a schematic cross-sectional front view of the valve crimping device of FIG. 10D, as viewed along the line 11D-1 ID in FIG. 10D, in the crimped configuration according to an example.
  • FIG. 12 is a side view of a delivery apparatus with an implantable prosthetic valve mounted on a valve mounting portion of the delivery apparatus according to an example.
  • FIG. 13 is a flow chart depicting an example of a method of crimping an implantable prosthetic valve to a valve delivery apparatus.
  • FIG. 14 is a schematic cross-sectional front view of a valve crimping device similar to the valve crimping device of FIGS. 10A-10D, taken from a view analogous to that of FIGS. 11A-1 ID, with a support body coupled to each of a first side portion and a second side portion of the valve crimping device, according to an example.
  • FIG. 17 is a perspective view of the support body of FIG. 16 supporting a frame of an implantable prosthetic valve according to an example.
  • FIG. 18 is a side perspective view of the support body of FIG. 16 supporting an implantable prosthetic valve according to an example.
  • FIG. 19 is a top side perspective view of the support body and implantable prosthetic valve of FIG. 18.
  • FIG. 20 is a perspective view of a second side portion of the valve crimping device of FIGS. 14-15.
  • FIG. 21 is a perspective view of the second side portion of the valve crimping device of FIG. 20 with the support body of FIGS. 16-18 operatively coupled to the valve crimping device.
  • FIG. 22 is a schematic cross-sectional front view of the valve crimping device of FIG. 21, as viewed along the line 22-22 in FIG. 21, with the support body operatively coupled to the valve crimping device and with the implantable prosthetic valve supported within the valve crimping device by the support body.
  • 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).
  • a delivery apparatus (sometimes referred to as a catheter) 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.
  • 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.
  • 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 balloon-expandable implantable prosthetic valve is typically placed over an expandable balloon on a catheter shaft.
  • the valve is expanded and then crimped on the balloon.
  • a valve mounting assembly such that the implantable prosthetic valve can be crimped onto the valve delivery apparatus only in an intended configuration, for example, with an inflow end portion of the implantable prosthetic valve facing a proximal direction with respect to the valve delivery apparatus.
  • Such a configuration may be utilized, for example, when the implantable prosthetic valve to be used to replace a native or previously implanted mitral valve via a transseptal delivery approach.
  • Such a configuration also may be utilized, for example, when the implantable prosthetic valve is to be used to replace a native or previously implanted aortic valve via a transventricular (for example, transapical) delivery approach.
  • transventricular for example, transapical
  • the present disclosure generally is directed to examples of implantable valve preparations assemblies, examples of mounting assemblies, and examples of methods of utilizing various components of prosthetic valve preparation assemblies and/or mounting assemblies to prepare an implantable prosthetic valve for delivery to a target implantation site.
  • valve crimping device 1400 can be configured to sequentially engage various mounting components for supporting the implantable prosthetic valve 1100 and the valve delivery apparatus 1200 therein from a common side (for example, a proximal side) of the valve crimping device 1400.
  • the valve crimping device 1400 can also include various components for maintaining the valve crimping device 1400 in a configuration in which the implantable prosthetic valve 1100 may be engaged by and held within the valve crimping device 1400 while such mounting components are removed from and/or coupled to the valve crimping device 1400.
  • terms such “open configuration,” “crimped configuration,” and the like may be understood as referring to corresponding configurations of the rotatable body 1434, of the handle 1440, of the pressing surfaces 1442, and/or of the valve crimping device 1400.
  • the crimped configuration of the rotatable body 1434 described above equivalently may be understood as describing, referring to, and/or corresponding to a crimped configuration of the handle 1440, of the pressing surfaces 1442, and/or of the valve crimping device 1400, and such descriptions may be used interchangeably to describe a given configuration of the valve crimping device 1400 and/or any components thereof.
  • the valve crimping device 1400 can include a proximal side portion 1410 including a proximal opening 1412 that leads into the channel 1450.
  • the proximal side portion 1410 can include various mating structures for supporting components that can be used to position the implantable prosthetic valve 1100 and the valve delivery apparatus 1200 within the channel 1450.
  • the intermediate position of the handle 1440 additionally or alternatively may be described as corresponding to an intermediate configuration of the of the rotatable body 1434, of the pressing surfaces 1442, and/or of the valve crimping device 1400.
  • the crimp brake mechanism 1460 can facilitate loading the implantable prosthetic valve 1100 and the valve delivery apparatus 1200 into the same side of the valve crimping device 1400 (for example, via the proximal side portion 1410). This can be useful to help ensure that the implantable prosthetic valve 1100 is crimped onto the valve delivery apparatus 1200 in a preferred orientation.
  • the crimp brake mechanism 1460 can operate to restrict the rotatable body 1434 from rotating relative to the base 1430 when the handle 1440 is in the intermediate position.
  • the handle 1440 can be configured to rotate the rotatable body 1434 in a first direction 1404 to transition the rotatable body 1434 toward the crimped configuration.
  • the handle 1440 can be configured to rotate the rotatable body 1434 in a second direction 1406 opposite the first direction 1404 to transition the rotatable body 1434 toward the open configuration.
  • the crimp brake mechanism 1460 can restrict or prevent the handle 1440 from rotating the rotatable body 1434 in the first direction 1404 or in the second direction 1406. In this manner, when the handle 1440 is in the intermediate position, the crimp brake mechanism 1460 can restrict actuation of the handle 1440 in either direction, thus maintaining the channel diameter 1452 at an at least substantially constant size.
  • the catch unit 1462 can include a locking tab 1464 configured to be received within a corresponding tab receiver 1436 of the rotatable body 1434 (shown in FIG. 10B).
  • the locking tab 1464 can be biased toward and/or into contact with the rotatable body 1434 (for example, due to a spring force and/or the resiliency of the material forming the catch unit 1462) such that the locking tab 1464 automatically enters the tab receiver 1436 when the tab receiver 1436 is rotated into alignment with the locking tab 1464.
  • the tab receiver 1436 can receive the locking tab 1464 when the handle 1440 is rotated to the intermediate position, thus restricting or preventing the rotatable body 1434 from rotating relative to the catch unit 1462 and thus relative to the base 1430 until the locking tab 1464 is removed from the tab receiver 1436.
  • the crimp brake mechanism 1460 thus can operate to maintain the channel diameter 1452 at the intermediate diameter while the locking tab 1464 is received within the tab receiver 1436.
  • the valve crimping device 1400 can include a catch unit support 1486 that supports the catch unit 1462 relative to the base 1430.
  • the catch unit 1462 can be configured to be directly and/or fixedly coupled to the catch unit support 1486.
  • the catch unit 1462 also can be configured to be selectively and repeatedly coupled to and removed from the catch unit support 1486.
  • the catch unit support 1486 can be fixed relative to the base 1430 during use of the valve crimping device 1400 such that the catch unit 1462 also is fixed relative to the base 1430 when the catch unit 1462 is fixedly coupled to the catch unit support 1486.
  • the crimp stop 1480 of the crimp brake mechanism 1460 includes the catch unit support 1486.
  • the crimp stop 1480 includes a crimp stop body 1482 that defines and terminates at a crimp stop terminal end 1484 that includes and/or defines the catch unit support 1486.
  • the crimp stop 1480 can also operate to partially restrict rotation of the rotatable body 1434 relative to the base 1430. For example, when the catch unit 1462 is removed from the crimp stop 1480, actuating the handle 1440 in the first direction 1404 can bring the handle 1440 into engagement with the crimp stop terminal end 1484 of the crimp stop 1480, which can restrict further motion of the handle 1440 in the first direction.
  • a configuration in which the handle 1440 engages the crimp stop 1480 thus can correspond to and/or define the crimped configuration of the rotatable body 1434.
  • the crimp brake mechanism 1460 can include a mechanism that restricts, but does not prevent, rotation of the handle 1440 when in the intermediate position.
  • the crimp brake mechanism 1460 can include a detent engagement mechanism configured to partially restrict actuation of the handle 1440 away from the intermediate position, such as via engagement of a biased and/or spring-loaded ball or tab into a ramped detent.
  • the crimp brake mechanism 1460 can be configured such that the handle 1440 can be transitioned away from the intermediate position by applying a torque to the handle 1440 that is in excess of a threshold torque that removes the ball/tab from the detent.
  • the implantable prosthetic valve 1100 can include an annular frame 1102 defining a frame central passage 1104 and a valve assembly 1110 positioned within the frame central passage 1104.
  • the valve assembly 1110 can include a plurality of leaflets 1112 configured to allow a flow of fluid therethrough from an inflow end region 1120 to an outflow end region 1122 of the implantable prosthetic valve 1100.
  • the annular frame 1102 is radially expandable and contractable to transition the implantable prosthetic valve 1100 between a delivery configuration (as shown in FIG. 4) and an operational configuration (as shown in FIG. 12). When in the delivery configuration, the implantable prosthetic valve 1100 is sufficiently reduced in diameter to be sized for delivery through the patient’s vasculature.
  • the mounting assembly can include a support body 1500 (FIG. 5) that is configured to support and/or maintain one or more leaflets 1112 of the prosthetic valve in an open position while supporting the implantable prosthetic valve 1100 within the channel 1450 of the valve crimping device 1400.
  • FIG. 5 An exemplary support body 1500 is shown in FIG. 5.
  • the support body 1500 can be configured to be inserted into a valve crimping device, such as the valve crimping device 1400 of FIG. 1.
  • the support body 1500 can include a support portion 1510 configured to support the implantable prosthetic valve 1100 and a coupling portion 1520 configured to be coupled to the valve crimping device 1400.
  • the support portion 1510 can include an outward-facing support surface 1512 that is configured to receive the implantable prosthetic valve 1100 thereon, such as via engagement with the leaflets 1112.
  • the support portion 1510 can extend away from the coupling portion 1520 with a tapered profile. In other examples, the support portion 1510 can extend away from the coupling portion 1520 with a cylindrical profile.
  • the support body 1500 can be configured to be operatively coupled to the valve crimping device 1400 in any suitable manner.
  • the proximal side portion 1410 of the valve crimping device 1400 can include a support body coupling structure 1414 (FIG. 10A), and the coupling portion 1520 can include an alignment structure 1522 (FIG. 5) configured to engage the support body coupling structure 1414 to operatively couple the support body 1500 to the valve crimping device 1400.
  • the mounting assembly also can include a ring body 1600 for defining an axial and/or rotational orientation of the implantable prosthetic valve 1100 relative to the support body 1500.
  • the ring body 1600 can be configured to be selectively coupled to the support body 1500, such as by surrounding a portion of the support portion 1510 with the ring body 1600 in the manner shown in FIG. 7.
  • the preferred axial position of the implantable prosthetic valve 1100 relative to the support body 1500 may correspond to a preferred axial position of the implantable prosthetic valve 1100 relative to the channel 1450 when the support body 1500 is operatively coupled to the valve crimping device 1400. This in turn may correspond to an axial position of the valve mounting portion of the valve delivery apparatus 1200 as the implantable prosthetic valve 1100 is crimped onto the valve delivery apparatus 1200. Mounting the implantable prosthetic valve 1100 with the inflow end region 1120 in engagement with the valve engagement surface 1602 also can ensure that the inflow end region 1120 faces the proximal side portion 1410 of the valve crimping device 1400 when the support body 1500 supports the implantable prosthetic valve 1100 within the channel 1450.
  • the ring body 1600 can engage a surface of the support body 1500 to position the valve engagement surface 1602 relative to the support body 1500.
  • the ring body 1600 can be configured to be coupled to the support body 1500 only in a predetermined axial orientation relative to the support body 1500.
  • the ring body can include a proximal surface 1604 opposed to the valve engagement surface 1602, and the support body 1500 can include a positioning surface 1530 (shown in FIG. 5) that engages the proximal surface 1604 when the ring body 1600 is operatively coupled to the support body 1500.
  • the support body 1500 and/or the ring body 1600 can include one or more structures (for example, annular grooves and/or protrusions) configured to engage one another to define the preferred axial orientation.
  • the ring body 1600 can include one or more rotational alignment indicators 1606 configured to facilitate positioning the implantable prosthetic valve 1100 with a preferred rotational orientation relative to the support body 1500.
  • aligning the rotational alignment indicators 1606 with corresponding features of the implantable prosthetic valve 1100 (for example, commissure structures) when mounting the implantable prosthetic valve 1100 to the support body 1500 can operate to orient the implantable prosthetic valve 1100 in the preferred rotational orientation relative to the support body 1500.
  • the rotational alignment indicators 1606 can take any suitable form, such as raised regions, depressed regions, printed indicators, etc.
  • the mounting assembly also can include a positioning device 1700 configured to support at least a valve mounting portion 1230 (FIG. 1) of the valve delivery apparatus 1200 within the channel 1450 of the valve crimping device 1400.
  • the positioning device 1700 includes a body 1710 with a first portion 1712 and a second portion 1714 joined at a hinge 1716 and defining a central channel 1718 therebetween.
  • the positioning device 1700 also can include a crimping device coupling structure 1720 configured to operatively couple the positioning device 1700 to the valve crimping device 1400.
  • the crimping device coupling structure 1720 can be configured to couple the positioning device 1700 to the valve crimping device 1400 in any suitable manner.
  • the proximal side portion 1410 of the valve crimping device 1400 can include a positioning device coupling structure 1420
  • the crimping device coupling structure 1720 can include a flange portion 1722 (FIG. 8) with one or more mating elements 1724 configured to engage the positioning device coupling structure 1420.
  • the second portion 1714 of the body 1710 includes the flange portion 1722.
  • the mating elements 1724 are configured to engage with and disengage with the positioning device coupling structure 1420 via rotation of the positioning device 1700 relative to the positioning device coupling structure 1420.
  • the positioning device 1700 can be axially aligned with the positioning device coupling structure 1420 by inserting the mating elements 1724 into the slots 1416 associated with the support body coupling structure 1414 and rotating the flange portion 1722 in a first coupling direction (for example, clockwise) to insert the mating elements 1724 into the positioning device coupling structure 1420.
  • the positioning device coupling structure 1420 may be described as at least partially defining the slots 1416 of the support body coupling structure 1414.
  • FIG. 1 Additional examples of components of a mounting assembly that may be used in conjunction with the systems and methods of the present disclosure, such as the support body 1500, the ring body 1600, and/or the positioning device 1700, are described at least in International Patent Application No. PCT/US2021/047063, the disclosure of which is hereby incorporated by reference in its entirety. While the present disclosure generally relates to examples in which the mounting assembly includes the support body 1500 and the positioning device 1700, it is to be understood that the mounting assembly can omit the positioning device 1700.
  • the support body 1500 can be used in conjunction with the valve crimping device 1400 as described herein independent of, and optionally without, use of the positioning device 1700.
  • valve crimping device 1400, the support body 1500, and/or the positioning device 1700 can include additional indicia (for example, colors, images, symbols, etc.) to further ensure proper coupling orientations.
  • additional indicia for example, colors, images, symbols, etc.
  • the proximal side portion 1410 of the valve crimping device 1400, the support body 1500, and/or the positioning device 1700 each can have a common first color that is different from a second color of the distal side portion of the valve crimping device 1400.
  • FIGS 10A-10D illustrate a sequence of operations of using the valve crimping device 1400 and the crimp brake mechanism 1460 thereof to crimp the implantable prosthetic valve 1100 to the valve delivery apparatus 1200 (not shown in FIGS. 10A-10D).
  • FIGS. 11A-1 ID schematically represent cross-sectional views of the valve crimping device 1400 in configurations correspond to FIGS. 10A-10D, respectively, and with various components received within the channel 1450 as applicable.
  • FIGS. 10A and 11 A correspond to a configuration in which the valve crimping device 1400 is in the open configuration such that the channel diameter 1452 of the channel 1450 is the first diameter.
  • the implantable prosthetic valve 1100 can be freely inserted into the channel 1450, such as when mounted to and supported by the support body 1500.
  • the pressing surfaces 1442 of the valve crimping device 1400 are spaced apart from the implantable prosthetic valve 1100.
  • the support body 1500 is operatively coupled to the proximal side portion 1410 of the valve crimping device via engagement with the support body coupling structure 1414.
  • the implantable prosthetic valve 1100 can have a valve length 1106, and the channel 1450 can extend along a channel length 1454, as measured parallel to the central axis 1402, that is equal to or greater than the valve length 1106.
  • Such a configuration can facilitate applying an even compressive force to a full length of the implantable prosthetic valve 1100 to produce a well-controlled crimp profile.
  • FIG. 10A rotating the handle 1440 in the first direction 1404 begins to move the pressing surfaces 1442 toward the central axis 1402 to reach the configuration shown in FIGS. 10B and 1 IB.
  • this configuration may correspond to a configuration in which the pressing surfaces 1442 have come into contact with the implantable prosthetic valve 1 100.
  • FIG. 10B additionally shows the tab receiver 1436 of the crimp brake mechanism 1460 approaching the catch unit 1462.
  • Rotating the handle 1440 further in the first direction 1404 brings the valve crimping device 1400 to the intermediate configuration shown in FIGS.
  • the handle 1440 is retained in the intermediate position via engagement of the locking tab 1464 of the catch unit 1462 (FIG. 2) and the tab receiver 1436 (FIG. 10B).
  • the intermediate position of the handle 1440 may correspond to a position in which the handle extends vertically upward from the rotatable body 1434, such as in a 12 o’clock position.
  • the pressing surfaces 1442 positively engage the implantable prosthetic valve 1100 such that the support body 1500 can be removed (for example, manually by the user or automatically ejected due to the jaws of the crimper) from the valve crimping device 1400 to allow the positioning device 1700 to be operatively coupled to the positioning device coupling structure 1420.
  • the valve delivery apparatus 1200 can be operatively coupled to the positioning device 1700, thereby positioning the valve mounting portion 1230 of the valve delivery apparatus 1200 within the channel 1450 radially interior of the implantable prosthetic valve 1100.
  • one or more shafts of the valve delivery apparatus 1200 can extend from the valve mounting portion 1230 to the handle portion 1204 of the valve delivery apparatus 1200 (FIG. 1) via the proximal opening 1412 of the valve crimping device 1400.
  • FIGS. 10D and HD illustrate the crimped configuration of the valve crimping device 1400, in which the handle 1440 engages the crimp stop 1480 to restrict further motion of the handle 1440 in the first direction 1404.
  • the pressing surfaces 1442 bring the channel diameter 1452 to the second diameter such that the implantable prosthetic valve 1100 is fully crimped onto the valve mounting portion 1230 of the valve delivery apparatus 1200.
  • the method 2000 includes, with a valve crimping device in an open configuration, operatively coupling, at 2040, a support body on which the implantable prosthetic valve is mounted to a proximal side portion of the valve crimping device to position the implantable prosthetic valve within a channel of the valve crimping device.
  • the method 2000 additionally includes transitioning, at 2050, the valve crimping device to an intermediate configuration, and removing, at 2070, the support body from the valve crimping device.
  • the valve crimping device supports the implantable prosthetic valve within the channel.
  • the method 2000 additionally includes operatively coupling, at 2080, a positioning device to the proximal side portion of the valve crimping device and mounting, at 2090, the valve delivery apparatus to the positioning device to position the valve delivery apparatus within the channel.
  • the method further can include transitioning, at 2120, the valve crimping device to a crimped configuration. When the valve crimping device is in the crimped configuration, the valve crimping device crimps the implantable prosthetic valve onto a valve mounting portion of the valve delivery apparatus.
  • the operatively coupling the positioning device to the proximal side portion at 2080 is performed subsequent to the removing the support body from the valve crimping device at 2070.
  • the method 2000 can include operatively coupling only one or the other of the support body or the positioning device to the valve crimping device at a given time.
  • each of the removing the support body from the valve crimping device at 2070 and the operatively coupling the positioning device to the proximal side portion at 2080 is performed while the valve crimping device is in the intermediate configuration, such as to retain the implantable prosthetic valve within the channel during such operations.
  • the method 2000 includes retaining, at 2060, the valve crimping device in the intermediate configuration during the removing the support body from the valve crimping device at 2070 and/or during the operatively coupling the positioning device to the proximal side portion at 2080.
  • the retaining the valve crimping device in the intermediate configuration at 2060 can include activating, at 2062, a crimp brake mechanism of the valve crimping device.
  • the activating the crimp brake mechanism at 2062 can include mechanically engaging, at 2064, the rotatable body with the crimp brake mechanism to restrict rotation of the rotatable body relative to the base.
  • the operatively coupling the support body to the proximal side portion at 2040 can be performed in any suitable manner.
  • the support body can include a support portion configured to support the implantable prosthetic valve and a coupling portion configured to be coupled to the valve crimping device
  • the proximal side portion can include a support body coupling structure
  • the coupling portion can include an alignment structure configured to engage the support body coupling structure to operatively couple the support body to the valve crimping device.
  • the operatively coupling the support body to the proximal side portion at 2040 can include engaging the support body coupling portion with the alignment structure.
  • the operatively coupling the support body to the proximal side portion at 2040 includes axially translating the support body toward the proximal side portion, and/or the removing the support body from the valve crimping device at 2070 includes axially translating the support body away from the proximal side portion.
  • the operatively coupling the positioning device to the proximal side portion at 2080 can be performed in any suitable manner.
  • the positioning device can include a crimping device coupling structure configured to operatively couple the positioning device to the crimping device
  • the proximal side portion of the crimping device can include a positioning device coupling structure
  • the crimping device coupling structure can include a flange portion with one or more mating elements configured to engage the positioning device coupling structure to operatively couple the positioning device to the crimping device.
  • the operatively coupling the positioning device to the proximal side portion at 2080 can include engaging the positioning device coupling structure with the one or more mating elements.
  • the operatively coupling the positioning device to the proximal side portion at 2080 can include rotating the positioning device relative to the proximal side portion in a first coupling direction.
  • the method 2000 additionally includes removing, at 2140, the positioning device from the proximal side portion of the valve crimping device.
  • the removing the positioning device from the proximal side portion at 2140 includes rotating the positioning device relative to the proximal side portion in a second coupling direction opposite the first coupling direction.
  • the method 2000 additionally includes, prior to the operatively coupling the support body to the proximal side portion at 2040, mounting, at 2020, the implantable prosthetic valve on the support body.
  • the support body can include a support portion configured to support the implantable prosthetic valve and a coupling portion configured to be coupled to the valve crimping device
  • the mounting the implantable prosthetic valve on the support body at 2020 can include inserting the support portion within an annular frame of the implantable prosthetic valve such that one or more leaflets of the implantable prosthetic valve are maintained in an open position.
  • the mounting the implantable prosthetic valve on the support body at 2020 can include mounting such that an inflow end region of the implantable prosthetic valve faces the coupling portion.
  • the method 2000 additionally includes, prior to the mounting the implantable prosthetic valve on the support body at 2020, operatively coupling, at 2010, a ring body to the support body.
  • the mounting the implantable prosthetic valve on the support body at 2020 can include engaging a valve engagement surface of the ring body with a portion of the implantable prosthetic valve to position the implantable prosthetic valve at a preferred axial position relative to the support body.
  • the method 2000 additionally can include, prior to the operatively coupling the support body to the proximal side portion at 2040, removing, at 2030, the ring body from the support body.
  • the mounting the valve delivery apparatus to the positioning device at 2090 can be performed in any suitable manner.
  • the positioning device can include a body comprising a first portion and a second portion joined at a hinge and defining a central channel therebetween, and the mounting the valve delivery apparatus to the positioning device at 2090 can include pivoting the first portion toward the second portion to retain the one or more shafts within the central channel.
  • FIG. 14 is a schematic cross- sectional representation of an example in which an implantable prosthetic valve 1130 is positioned within a central channel 1806 of a valve crimping device 1800.
  • the implantable prosthetic valve 1130 is supported upon a support surface 1822 of a support body 1820, which may be similar to the support body 1500 described above.
  • the support body 1820 is operatively coupled to a first side portion 1802 of the valve crimping device 1800 to position the implantable prosthetic valve 1130 within the central channel 1806.
  • the first side portion 1802 can be a distal side portion of the valve crimping device 1800 (for example, relative to a delivery apparatus that is subsequently inserted into the central channel 1806).
  • a second side portion 1804 of the valve crimping device 1800 that is opposed to the first side portion 1802 can be a proximal side portion of the valve crimping device 1800.
  • the configuration illustrated in solid lines may correspond to a retrograde configuration of the implantable prosthetic valve 1 130 when crimped upon the delivery apparatus.
  • the valve crimping device 1800 includes first pressing surfaces 1810 and second pressing surfaces 1812, the second pressing surfaces 1812 being configured to engage and crimp the implantable prosthetic valve 1130.
  • first pressing surfaces 1810 also can be referred to as outer pressing surfaces 1810
  • second pressing surfaces 1812 also can be referred to as inner pressing surfaces 1812.
  • the edges of the inner pressing surfaces 1812 proximate to the first side portion 1802 are axially offset from the edges of the outer pressing surfaces 1810 proximate to the first side portion 1802.
  • the edges of the first pressing surfaces 1810 and the second pressing surfaces 1812 can form a “stepped” configuration that can permit the conical shape of the support surface 1822 to penetrate sufficiently far into the central channel 1806 to position the implantable prosthetic valve 1130 at a desired axial location.
  • the axial position of the implantable prosthetic valve 1130 in FIG. 14 may correspond to a valve mounting portion of the delivery apparatus, such as the valve mounting portion 1230 of the delivery apparatus 1200 discussed above.
  • the valve crimping device 1800 may be used to crimp the implantable prosthetic valve 1130 upon a delivery apparatus in an antegrade configuration and/or in an orientation suitable for implantation in the mitral position via a transseptal delivery approach or implantation in the aortic position via a transventricular (for example, transapical) delivery approach.
  • the support body 1820 may be coupled to the second side portion 1804 of the valve crimping device 1800.
  • the support body 1820 can be used to place the prosthetic valve 1130 in a configuration in which the outflow end region 1 132 faces toward the first side portion 1082 and/or in a distal direction.
  • the second side portion 1804 can be a proximal side portion 1804 of the valve crimping device 1800 (for example, relative to a delivery apparatus that is subsequently inserted into the central channel 1806), similar to the proximal side portion 1410 of the valve crimping device 1400 discussed above.
  • the configuration and/or geometry of the valve crimping device 1800 and of the support body 1820 may (in some instances) restrict the support body 1820 from positioning the implantable prosthetic valve 1130 at the desired axial location without obstruction from the valve crimping device 1800.
  • the second pressing surfaces 1812 restrict the support body 1820 from penetrating sufficiently far into the central channel 1806 from the second side portion 1804 position the implantable prosthetic valve 1130 at the desired axial location while remaining in contact with the implantable prosthetic valve 1130.
  • a radial gap 1824 exists between the support surface 1822 and the implantable prosthetic valve 1130 when the support body 1820 is positioned as far as possible into the central channel 1806.
  • the support body 1820 could be geometrically modified in order allow the support body 1820 to position the implantable prosthetic valve 1130 farther into the central channel 1806 via the second side portion 1804.
  • the conical support surfaces 1822 could be modified to exhibit a shallower taper angle to allow the support body 1820 to penetrate further into the central channel 1806.
  • Such a modification may (in some instances) compromise other desired functional characteristics of the support body 1820, such as the reliability with which the support body 1820 is ejected from the valve crimping device 1800 during the crimping process (for example, as discussed above with respect to FIG. 11C).
  • FIG. 16 illustrates a support body 1900, which may be used in lieu of the support body 1820 to alleviate the functional constraints discussed with respect to FIG. 14.
  • the support body 1900 includes a coupling portion 1902, a support portion 1904 (valve support portion), and one or more device engagement mechanisms 1906.
  • the support body 1900 can share any suitable structural and/or functional attributes with the support body 1500 of FIGS. 5 and 11A-11C discussed above and can be used in a manner analogous to that discussed above with respect to the support body 1500.
  • the support body 1900 can be configured to be used in combination with a positioning device (for example, the positioning device 1700 of FIGS. 8 and HC-l l D) for supporting a valve delivery apparatus within the central channel 1806.
  • a positioning device for example, the positioning device 1700 of FIGS. 8 and HC-l l D
  • the support body 1900 and the positioning device can be configured to be operatively coupled to the same side of the valve crimping device 1800 (for example, the second side portion 1804) in sequence during a crimping procedure.
  • the coupling portion 1902 can be configured to releasably couple to a crimping device, such as the valve crimping device 1400 of FIGS. 1 and 10A-1 ID and/or the valve crimping device 1800 of FIGS. 14-15.
  • the support portion 1904 can be configured to be inserted into an implantable prosthetic valve (for example, the implantable prosthetic valve 1100 of FIGS. 1, 4, and 11A-12 and/or the implantable prosthetic valve 1130 of FIG. 14) so that leaflets of the prosthetic valve can contact and rest upon a ramped surface 1910 of the support portion 1904.
  • an implantable prosthetic valve for example, the implantable prosthetic valve 1100 of FIGS. 1, 4, and 11A-12 and/or the implantable prosthetic valve 1130 of FIG. 14
  • the device engagement mechanisms 1906 can be used to space the prosthetic valve away from the coupling portion 1902 and achieve a desired rotational and/or axial alignment of the prosthetic valve relative to the coupling portion 1902 and the crimping device. As described further below, the device engagement mechanisms 1906 can be further configured to hold the prosthetic valve in place relative to the support body 1900 (in the desired rotational and/or axial configuration). The engagement mechanisms can, for example, help prevent or reduce the likelihood of the prosthetic valve inadvertently moving relative to the support body 1900.
  • a distal side portion of the valve crimping device 1800 may refer to a portion of the valve crimping device 1800 that faces toward the distal direction relative to the valve delivery apparatus (for example, toward a distal portion of the valve delivery apparatus) when the valve delivery apparatus is received within the central channel 1806.
  • Portions and/or attributes of the support body 1900 accordingly may be described with reference to these descriptions of the valve crimping device 1800.
  • a portion of the support body 1900 that faces toward the proximal (or distal) side portion of the valve crimping device 1800 when the support body 1900 is operatively coupled to the valve crimping device 1800 may be referred to as a proximal (or distal) portion of the support body 1900.
  • aspects of the support body 1900 may be described in this manner even when the support body 1900 is removed from the valve crimping device 1800.
  • the support portion 1904 can extend from the coupling portion 1902, such as in a distal direction.
  • the coupling portion 1902 includes a cylindrical wall 1916 that extends away from the second end 1914 of the coupling portion 1902 toward the first end 1912 of the coupling portion 1902.
  • the second end 1914 can be referred to as the second end of the cylindrical wall 1916.
  • the coupling portion 1902 additionally includes an alignment structure 1918 extending between the cylindrical wall 1916 and the first end 1912.
  • the alignment structure 1918 can include one or more features that are configured to align with and/or engage corresponding features of the valve crimping device to define a rotational orientation of the support body 1900 relative to the valve crimping device.
  • the alignment structure 1918 includes a coupling portion body 1920 and a plurality of radial projections 1922 extending radially away from the coupling portion body 1920.
  • the cylindrical wall 1916 of the coupling portion 1902 can include one or more retaining members 1932 which can be configured as axial locking mechanisms that prevent the coupling portion 1902 from moving axially relative to the crimping device after the support body 1900 is attached to the crimping device.
  • the support body 1900 can be retained in a predetermined axial position within the crimping device, and relative to a delivery apparatus inserted into and coupled with the crimping device.
  • the coupling portion 1902 includes three retaining members 1932 spaced 120 degrees apart from one another around the coupling portion 1902.
  • the coupling portion 1902 can include more or less than two retaining members 1932 (e.g., one, two, four, or the like).
  • Each retaining member 1932 can comprise a finger with a free end 1934 and an attached end 1936 that are formed by a U-shaped slot 1933 in (through) the cylindrical wall 1916.
  • the free end 1934 includes a protrusion 1938 (or nub or bump) that protrudes radially outward from an outer surface of the free end 1934.
  • the retaining member 1932 can be configured as a cantilever, where the free end 1934 deflects radially inward as the support body 1900 is slid into the central channel of the crimping device and then deflects radially outward with the protrusion 1938 engaging a portion of the valve crimping device as discussed in more detail below.
  • the support body 1900 can include a visual indicator 1940 that enables a user to easily identify the type of support body 1900 being used.
  • the visual indicator 1940 is disposed in the coupling portion body 1920 and can comprise letters, numbers, and/or other indicia (“#” is shown for illustration purposes only) that correspond to the type of support body 1900 (such as a specified size out of several possible sizes, which may correspond to a size or type of prosthetic valve to be mounted onto the support portion 1904).
  • the support portion 1904 can be configured to support and/or rotationally align the prosthetic valve relative to a ramped surface 1910 of the support portion 1904 as the prosthetic valve is inserted into a channel of a crimping device (for example, the channel 1450 of the valve crimping device 1400 and/or the central channel 1806 of the valve crimping device 1800).
  • a crimping device for example, the channel 1450 of the valve crimping device 1400 and/or the central channel 1806 of the valve crimping device 1800.
  • the support portion 1904 includes a first end 1942 (which, in some examples, can be a proximal end) and second end 1944 (which, in some examples, can be a distal end).
  • the first end 1942 is disposed adjacent to the second end 1914 of the coupling portion 1902.
  • the first end 1942 is directly attached to or continuous with the second end 1914 of the coupling portion 1902.
  • the first end 1942 of the support portion 1904 can be attached to an axial wall 1946 of the coupling portion 1902.
  • the axial wall 1946 can be arranged normal to a central longitudinal axis 1901 of the support body 1900 and perpendicular to the cylindrical wall 1916.
  • Various portions and/or attributes of the support body 1900 can be described with reference to a longitudinal direction that is parallel to the central longitudinal axis 1901.
  • the support portion 1904 may be described as extending away from the coupling portion 1902 along the longitudinal direction.
  • the ramped surface 1910 extends from the first end 1942 to the second end 1944 of the support portion 1904.
  • the support body 1900 includes one or more axially extending device engagement mechanisms 1906 spaced circumferentially apart from one another around the support body 1900. In some examples, the support body 1900 includes three device engagement mechanisms 1906 (one for each commissure of the prosthetic valve).
  • the support body 1900 can include more or less than three device engagement mechanisms 1906 (for example, one, two, or the like).
  • each device engagement mechanism 1906 includes an attached end 1948 and a free end 1950 disposed axially away from the attached end 1948.
  • the attached end 1948 is disposed at (coupled to or formed together with) the second end 1914 of the coupling portion 1902.
  • each device engagement mechanism 1906 can be configured as a cantilever where the free end 1950 is configured to deflect and bend in the radial direction relative to the attached end 1948.
  • the attached end 1948 is disposed at (or formed with) the axial wall 1946 of the coupling portion 1902.
  • Each device engagement mechanism 1906 extends distally from the axial wall 1946.
  • the support portion 1904 can include one or more windows or cut-outs 1952 in the ramped surface 1910 that extend through at least a portion of the support portion 1904.
  • Each device engagement mechanism 1906 is aligned with and/or extends over a respective cut-out 1952 of the one or more cut-outs 1952.
  • the support portion 1904 can have one cut-out 1952 for each device engagement mechanism 1906 (e.g., three cut-outs 1952 in the example shown in FIGS. 6-11). As such, each cut-out 1952 can be configured to receive the free end 1950 of a respective device engagement mechanism 1906 therein.
  • the cut-outs 1952 are spaced circumferentially apart around the support portion 1904 with the ramped surface 1910 extending between adjacent cut-outs 1952.
  • Each cut-out 1952 can extend through a wall of the support portion 1904, from the ramped surface 1910 to an open region within or a space inside the support portion 1904.
  • each cut-out 1952 can extend through an entire thickness of the support portion 1904, between the outer ramped surface 1910 and an inner surface 1956 of the support portion 1904 that defines a portion of a central channel 1908 extending at least partially through the support body 1900.
  • Each cut-out 1952 can have a width (in the circumferential direction) that is at least as wide as, or wider than, the corresponding device engagement mechanism 1906.
  • each device engagement mechanism 1906 is configured to deflect or bend radially inward, into the corresponding cut-out 1952, in response to a radially inward directed force applied to its outer surface (e.g., during crimping with a crimping device).
  • each device engagement mechanism 1906 may be described as being configured to transition between an engaged configuration, in which the device engagement mechanism 1906 is positioned to engage the implantable prosthetic valve, and a disengaged configuration, in which the device engagement mechanism 1906 is deflected radially inward relative to the engaged configuration.
  • each device engagement mechanism 1906 when in the engaged configuration, can extend distally from the axial wall 1914 without deflection.
  • each device engagement mechanism 1906 is substantially straight when in the engaged configuration and is at least partially bent when in the disengaged configuration.
  • each device engagement mechanism 1906 may be configured to change in shape to transition between the engaged configuration and the disengaged configuration, with the disengaged configuration corresponding to a shape that is bent and/or deflected relative to that of the engaged configuration.
  • the device engagement mechanisms 1906 are positioned such that the implantable prosthetic valve may be axially moved relative to the support body 1900, such as to enable the implantable prosthetic valve to be ejected from the crimping device similar to the manner shown in FIG. 11C.
  • Each device engagement mechanism 1906 may be biased toward the engaged configuration, and/or may be configured to transition from the engaged configuration to the disengaged configuration responsive to a valve crimping device urging the device engagement mechanism 1906 radially inward.
  • each cut-out 1952 is disposed adjacent to the first end 1942 of the support portion 1904.
  • each cut-out 1952 can extend from the first end 1942 toward, but spaced away from, the second end 1944 of the support portion 1904.
  • each device engagement mechanism 1906 can include a retention feature 1954 that is configured to hold an implantable device such as an implantable prosthetic valve (for example, the implantable prosthetic valve 1100 and/or the implantable prosthetic valve 1130) when the implantable device is supported by the support body 1900.
  • an implantable device such as an implantable prosthetic valve (for example, the implantable prosthetic valve 1100 and/or the implantable prosthetic valve 1130) when the implantable device is supported by the support body 1900.
  • an implantable prosthetic valve for example, the implantable prosthetic valve 1100 and/or the implantable prosthetic valve 1130
  • the apparatuses disclosed herein such as the support body 1500 and/or the support body 1900, can be used in conjunction with any suitable implantable devices such as stents, grafts, embolic coils, and the like.
  • Each retention feature 1954 is shaped to hook around a portion of a frame of the implantable prosthetic valve.
  • FIG. 17 illustrates a configuration in which a frame 12 of a prosthetic valve 10 is supported by the support portion 1904.
  • the frame 12 shown in FIG. 17 is just one example of a structure that can be supported by the support portion 1904.
  • the retention features 1954 (and the entire support body 1900) can be adapted (shaped and/or sized) to hook around a variety of implantable device and/or prosthetic valve frames, such as any of the frames described herein.
  • FIG. 17 for ease of illustration.
  • the entire prosthetic valve including leaflets and, in some examples, a skirt can be retained on the support body 1900 by the retention features 1954, as shown in FIGS. 19-20.
  • each retention feature 1954 can be shaped as a hook (or hook-like) which defines a protrusion that can engage the implantable prosthetic valve 10 at one or more device engagement locations 1970.
  • the device engagement mechanism 1906 also can include a stop element 1962 configured to engage a portion of the frame 12 at one or more corresponding device engagement locations 1970, such as in the manner show in FIG. 17.
  • the retention feature 1954 is closer to a tip of the free end 1950 than the stop element 1962 and the stop element 1962 is closer to the attached end 1948 of the device engagement mechanism 1906 than the retention feature 1954.
  • the stop element 1962 can include a wall extending perpendicular, or approximately perpendicular, to the length of the device engagement mechanism 1906 that extends between the attached end 1948 and the free end 1950. A remainder, or leg 1964, of the device engagement mechanism 1906 extends from the stop element 1962 to the attached end 1948. Each leg 1964 can be at least partially received within a corresponding cut-out 1952 when the device engagement mechanism 1906 is in the disengaged configuration.
  • a region of the device engagement mechanism 1906 between the retention feature 1954 and the stop element 1962 can be configured to receive a strut (or struts) of the frame 12 of the implantable prosthetic valve 10.
  • this region of the device engagement mechanism 406 receives an intersection of struts 32 of the frame 12.
  • the retention feature 1954 can extend at least partially into an open cell 34 of the frame 12, thereby restricting the frame 12 from shifting axially and/or circumferentially relative to the support body 1900. In this way, the retention features 1954 can hold the frame 12 (and implantable prosthetic valve 10) in a specified axial and/or circumferential position relative to the support body 1900 and prevent the implantable prosthetic valve from being displaced away from such specified positions as the support body 1900 is inserted into a crimping device.
  • a thickness (in the radial direction) of the device engagement mechanisms 1906 can be specified such that each device engagement mechanism 1906 can deflect into the respective cut-out 1952 and become aligned with the ramped surface 1910 during crimping.
  • the pressing surfaces of the valve crimping device for example, the second pressing surfaces 1812 of FIG. 14
  • the retention features 1954 can urge the retention features 1954 radially inward until the retention features 1954 are radially aligned with the ramped surface 1910.
  • the retention feature 1954 can disengage the implantable prosthetic valve 10, allowing the support body 1900 to be ejected from the valve crimping device while the implantable prosthetic valve 10 remains positioned within the valve crimping device (as described herein, for example, with reference to FIGS. 11A- 1 ID).
  • the device engagement mechanisms 1906 can be made of a less stiff material than a remainder of the support body 1900.
  • the device engagement mechanisms 1906 can comprise a first polymer and the remainder of the support body 1900 can comprise a second polymer, where the first polymer is less stiff (and thus can bend or deflect more easily) than the second polymer.
  • the first polymer is Delrin, Acetal, ABS, or the like. As such, the device engagement mechanisms 1906 can have increased flexibility to capture and release the implantable prosthetic valve.
  • the device engagement mechanisms 1906 comprise a different material than a remainder of the alignment device
  • the device engagement mechanisms 1906 can be attached thereto (for example, to the axial wall 1946 of the coupling portion 1902) by a snap-fit connection, glue, or via over molding.
  • one or more rotational alignment indicators 1966 can be disposed in an axial wall 1968 proximate to an end region of the support portion 1904.
  • the end region corresponds to the second end 1944 of the support portion 1904.
  • Each rotational alignment indicator 1966 can be axially aligned with a corresponding device engagement mechanism 1906.
  • each rotational alignment indicator 1966 can be configured to indicate an axial location for a commissure of an implantable prosthetic valve when supported by the support portion 1904.
  • the rotational alignment indicators 1966 can be arrows, lines, or variously shaped markings formed in and/or protruding from the axial wall 1968.
  • the rotational alignment indicators 1966 can be colored differently than a remainder of the support body 1900.
  • the support body 1900 may not include rotational alignment indicators 1966.
  • FIGS. 18-19 illustrate an example in which the complete implantable prosthetic valve 10 is operatively coupled to and supported by the support body 1900.
  • the implantable prosthetic valve 10 includes a plurality of leaflets 20 configured to allow a flow of fluid therethrough from an inflow end region 24 to an outflow end region 26.
  • the support body 1900 can be configured to maintain the leaflets 20 in an open position.
  • the implantable prosthetic valve 10 additionally includes a skirt 28 covering a portion of the frame 12 proximate to the inflow end region 24.
  • the device engagement mechanisms 1906 may be axially aligned with respective commissures of the implantable prosthetic valve.
  • the device engagement mechanisms 1906 are axially aligned with respective commissures 22 of the frame 12.
  • FIGS. 20-21 illustrate a manner in which the support body 1900 may be operatively coupled to the valve crimping device 1800.
  • FIG. 20 illustrates a second side portion 1804 (for example, a proximal side portion) of the valve crimping device 1800 with the support body 1900 removed from the valve crimping device, while FIG. 21 shows the second side portion 1804 with the support body 1900 operatively coupled to the valve crimping device 1800.
  • the second side portion 1804 includes a support body coupling structure 1814 configured to receive and/or engage the alignment structure 1918 of the coupling portion 1902.
  • the support body coupling structure 1814 includes a plurality of slots 1816, each of which can receive a corresponding radial projection 1922 of the alignment structure 1918 in the manner shown in FIG. 21.
  • Each slot 1816 extend between and/or be defined by engagement arms 1842 of a positioning device coupling structure 1840 (for example, the positioning device coupling structure 1420 discussed above).
  • a positioning device coupling structure 1840 for example, the positioning device coupling structure 1420 discussed above.
  • each engagement arm 1842 defines a recess 1844 on an interior side (for example, on a distally facing side) thereof.
  • Each recess 1844 can receive a portion of a corresponding retaining member 1932 of the coupling portion 1902 as described in more detail below with reference to FIG. 22.
  • the three slots 1816 of the valve crimping device 1800 define three discrete rotational orientations of the support body 1900 when operatively coupled to the valve crimping device 1800.
  • this constraint may be sufficient to position the implantable prosthetic valve in a desired predetermined rotational configuration within the central channel 1806 when the implantable prosthetic valve is supported by the support body 1900 within the valve crimping device 1800.
  • the valve crimping device 1800 and/or the support body 1900 can include a visual indicator (for example, the visual indicator 1418 of FIG. 10A) configured to indicate the preferred rotational orientation for coupling the support body 1900 to the valve crimping device 1800.
  • FIG. 22 is a cross-sectional representation of a configuration in which the implantable prosthetic valve 1130 is supported by the support body 1900 and the support body 1900 is operatively coupled to the second side portion 1804 of the valve crimping device 1800.
  • FIG. 22 may thus be regarded as a simplified representation of the configuration of FIG. 21.
  • the device engagement mechanisms 1906 can engage the implantable prosthetic valve 10, such as via engagement with the retention feature 1954 and/or the stop element 1962, such that the frame 12 is spaced apart from the ramped surface 1910 of the support body 1900.
  • each device engagement location 1970 at which the device engagement mechanisms 1906 engage the implantable prosthetic valve 10 that are spaced apart from the ramped surface 1910 are spaced apart from the ramped surface 1910.
  • Example 1 A valve crimping device comprising: a handle configured to be manually actuated to crimp an implantable prosthetic valve around a valve delivery apparatus; and a crimp brake mechanism configured to at least partially retain the handle in an intermediate position in which the valve crimping device is configured to support the implantable prosthetic valve in a partially crimped configuration.
  • Example 2 The valve crimping device of any example herein, particularly example 1, further comprising: a base; a rotatable body mounted to the base and defining a central axis; and a plurality of pressing surfaces surrounding the central axis and collectively defining a channel, wherein the handle is configured to rotate the rotatable body relative to the base, wherein the pressing surfaces are radially movable within the rotatable body toward and away from the central axis as the rotatable body rotates relative to the base, and wherein a channel diameter of the channel varies as the pressing surfaces move toward and away from the central axis.
  • Example 3 The valve crimping device of any example herein, particularly example 2, wherein, when the handle is in the intermediate position, the crimp brake mechanism restricts the rotatable body from rotating relative to the base.
  • Example 5 The valve crimping device of any example herein, particularly example 4, wherein the handle is configured to rotate the rotatable body in a first direction to transition the rotatable body toward the crimped configuration, wherein the handle is configured to rotate the rotatable body in a second direction opposite the first direction to transition the rotatable body toward the open configuration, and wherein, when the handle is in the intermediate position, the crimp brake mechanism restricts the handle from rotating the rotatable body in each of the first direction or the second direction.
  • Example 6 The valve crimping device of any example herein, particularly any one of examples 2-5, wherein the crimp brake mechanism comprises a catch unit that mechanically engages the rotatable body when the handle is in the intermediate position.
  • Example 7 The valve crimping device of any example herein, particularly example
  • one of the catch unit or the rotatable body comprises a locking tab
  • the other of the catch unit or the rotatable body comprises a tab receiver that receives the locking tab to restrict rotation of the rotatable body when the handle is in the intermediate position.
  • Example 8 The valve crimping device of any example herein, particularly example
  • catch unit comprises a tab removal grip feature configured to facilitate removal of the locking tab from the tab receiver.
  • Example 9 The valve crimping device of any example herein, particularly example
  • Example 10 The valve crimping device of any example herein, particularly any one of examples 8-9, wherein the tab removal grip feature is configured to be gripped by a user to enable the user to pull a portion of the catch unit away from the rotatable body.
  • Example 12 The valve crimping device of any example herein, particularly any one of examples 6-11, wherein the catch unit is configured to be directly coupled to the base.
  • Example 13 The valve crimping device of any example herein, particularly any one of examples 6-12, wherein the catch unit is configured to be selectively and repeatedly coupled to and removed from the base.
  • Example 14 The valve crimping device of any example herein, particularly any one of examples 6-13, further comprising a catch unit support that supports the catch unit relative to the base.
  • Example 17 The valve crimping device of any example herein, particularly any one of examples 14-16, wherein the base comprises the catch unit support.
  • Example 20 The valve crimping device of any example herein, particularly any one of examples 18-19, wherein one of the catch unit or the rotatable body comprises a locking tab, wherein the other of the catch unit or the rotatable body comprises a tab receiver that receives the locking tab to restrict rotation of the rotatable body when the handle is in the intermediate position, wherein, when the catch unit is operatively coupled to the crimp stop and the rotatable body is in an open position, actuating the handle in a first direction to the intermediate position brings the locking tab into engagement with the tab receiver such that the channel diameter is maintained at an intermediate diameter, and wherein, when the catch unit is removed from the crimp stop, actuating the handle in the first direction to engage the crimp stop operates to bring the channel diameter to a second diameter that is smaller than the intermediate diameter.
  • Example 24 The valve crimping device of any example herein, particularly any one of examples 14-23, wherein the catch unit comprises a support receiver that receives at least a portion of the catch unit support when the catch unit is mechanically coupled to the catch unit support.
  • Example 37 The mounting assembly of any example herein, particularly any one of examples 32-36, wherein the support body comprises a support portion configured to support the implantable prosthetic valve and a coupling portion configured to be coupled to the valve crimping device.
  • Example 41 The mounting assembly of any example herein, particularly any one of examples 37-40, wherein the proximal side portion comprises a support body coupling structure, and wherein the coupling portion comprises an alignment structure configured to engage the support body coupling structure to operatively couple the support body to the valve crimping device.
  • Example 42 The mounting assembly of any example herein, particularly example 41, wherein the support body coupling structure is configured to engage the alignment structure in one of a finite number of predetermined rotational orientations.
  • Example 43 The mounting assembly of any example herein, particularly any one of examples 41-42, wherein the support body coupling structure is configured to receive at least a portion of the alignment structure when the support body is operatively coupled to the valve crimping device.
  • Example 45 The mounting assembly of any example herein, particularly any one of examples 41-44, wherein the alignment structure is configured to engage the support body coupling structure such that, when the support body is operatively coupled to the valve crimping device, the support body may be removed from the valve crimping device by sliding the support body axially away from the valve crimping device.
  • the ring body comprises a valve engagement surface
  • the mounting assembly is configured such that, when the ring body is operatively coupled to the support body, mounting the implantable prosthetic valve onto the support body in engagement with the valve engagement surface, the implantable prosthetic valve is positioned at the preferred axial position relative to the support body.
  • Example 49 The mounting assembly of any example herein, particularly example
  • Example 52 The mounting assembly of any example herein, particularly any one of examples 47-51, wherein the ring body is configured to be coupled to the support body only in a preferred axial orientation relative to the support body.
  • Example 53 The mounting assembly of any example herein, particularly any one of examples 32-52, further comprising a positioning device configured to support the valve mounting portion within the channel, wherein the positioning device is configured to be operatively coupled to the proximal side portion of the valve crimping device.
  • Example 54 The mounting assembly of any example herein, particularly example 53, wherein the mounting assembly is configured such that, when one of the support body or the positioning device is operatively coupled to the valve crimping device, the other of the support body or the positioning device is restricted from being operatively coupled to the valve crimping device.
  • Example 55 The mounting assembly of any example herein, particularly any one of examples 53-54, wherein the valve delivery apparatus comprises a handle portion and one or more shafts extending away between the valve mounting portion and the handle portion, and wherein the mounting assembly is configured such that, when the positioning device supports the valve mounting portion within the channel, the one or more shafts extend from the valve mounting portion to the handle portion via the proximal opening.
  • Example 57 The mounting assembly of any example herein, particularly example
  • Example 58 The mounting assembly of any example herein, particularly example
  • Example 59 The mounting assembly of any example herein, particularly any one of examples 57-58, wherein the second portion of the body comprises the flange portion.
  • Example 60 The mounting assembly of any example herein, particularly any one of examples 57-59, wherein the proximal side portion of the valve crimping device comprises a support body coupling structure, wherein the support body comprises an alignment structure configured to engage the support body coupling structure to operatively couple the support body to the valve crimping device, wherein the alignment structure comprises one or more radial projections, wherein the support body coupling structure comprises one or more slots configured to receive the one or more radial projections, and wherein the positioning device coupling structure at least partially defines the one or more slots.
  • a prosthetic valve preparation assembly comprising: an implantable prosthetic valve comprising an annular frame defining a frame central passage and a valve assembly positioned within the frame central passage; a valve delivery apparatus configured to deliver the implantable prosthetic valve through a patient’s vasculature to a target implantation site; and a valve crimping device for crimping the implantable prosthetic valve around a portion of the valve delivery apparatus, wherein the valve delivery apparatus comprises: a steerable guide catheter comprising a handle portion and a guide catheter shaft extending from the handle portion; a balloon catheter extending through the guide catheter; and an inflatable balloon mounted to the balloon catheter, wherein the valve delivery apparatus is configured such that the implantable prosthetic valve is mounted directly to the inflatable balloon prior to introducing the valve delivery apparatus into the patient’s vasculature, and wherein the valve crimping device is the valve crimping device of any example herein, particularly any one of examples 1-60.
  • Example 62 The prosthetic valve preparation assembly of any example herein, particularly example 61, wherein the valve crimping device comprises a channel configured to receive each of the implantable prosthetic valve and a portion of the valve delivery apparatus, and wherein the channel extends along a channel length, as measured along a direction parallel to a central axis of the valve crimping device, that is equal to or greater than a valve length of the implantable prosthetic valve.
  • Example 63 The prosthetic valve preparation assembly of any example herein, particularly any one of examples 61-62, wherein the balloon catheter comprises a proximal portion adjacent to the handle portion, a distal portion opposite the proximal portion, and a balloon catheter shaft that extends from the proximal portion and through the handle portion and the guide catheter shaft.
  • Example 64 The prosthetic valve preparation assembly of any example herein, particularly example 63, wherein the inflatable balloon is mounted to the distal portion.
  • Example 65 The prosthetic valve preparation assembly of any example herein, particularly any one of examples 61-64, wherein the guide catheter and the balloon catheter are configured to slide longitudinally relative to one another to facilitate delivery and positioning of the implantable prosthetic valve at the target implantation site.
  • Example 66 The prosthetic valve preparation assembly of any example herein, particularly any one of examples 61-65, wherein the balloon catheter shaft is an outer balloon catheter shaft; and wherein the balloon catheter further comprises an inner balloon catheter shaft that extends from the proximal portion and coaxially through the outer balloon catheter shaft and the inflatable balloon.
  • Example 67 The prosthetic valve preparation assembly of any example herein, particularly example 66, wherein the balloon catheter comprises a fluid passageway that is in fluid communication with an annular space defined between the inner balloon catheter shaft and the outer balloon catheter shaft and that is fluidly connectable to a fluid source for inflating the inflatable balloon.
  • Example 68 The prosthetic valve preparation assembly of any example herein, particularly any one of examples 61-67, wherein the annular frame is radially expandable and contractable to transition the implantable prosthetic valve between a delivery configuration, in which the implantable prosthetic valve is sized for delivery through the patient’ s vasculature, and an operational configuration, in which the implantable prosthetic valve is sized to be operatively mounted at the target implantation site.
  • Example 69 The prosthetic valve preparation assembly of any example herein, particularly example 68, wherein the valve delivery apparatus is configured such that inflating the inflatable balloon with the implantable prosthetic valve mounted to the inflatable balloon operates to transition the implantable prosthetic valve from the delivery configuration to the operational configuration.
  • Example 70 A support body configured to support an implantable prosthetic valve within a channel of a valve crimping device, comprising: a coupling portion configured to be coupled to the valve crimping device; and a support portion extending from the coupling portion and configured to support the implantable prosthetic valve, wherein the support portion comprises: an outward-facing ramped surface extending away from the coupling portion with a radially tapered profile; and a device engagement mechanism extending radially exterior of the ramped surface and configured to engage the implantable prosthetic valve to at least partially support the implantable prosthetic valve within the channel when the support body is positioned within the channel, wherein the valve crimping device comprises a proximal side portion with a proximal opening that leads into the channel, and wherein the support body is configured to be operatively coupled to the proximal side portion of the valve crimping device.
  • Example 71 The support body of any example herein, particularly example 70, wherein the support body is configured to be removed from the valve crimping device while the implantable prosthetic valve is supported within the channel by the valve crimping device.
  • Example 72 The support body of any example herein, particularly any one of examples 70-71, wherein the valve crimping device is configured to receive a valve delivery device that is supported by a positioning device, and wherein each of the support body and the positioning device are configured to be coupled to the proximal side portion of the valve crimping device.
  • Example 73 The support body of any example herein, particularly any one of examples 70-72, wherein the implantable prosthetic valve comprises an inflow end region and an outflow end region, and wherein the support body is configured to support the implantable prosthetic valve such that the inflow end region faces the proximal side portion of the valve crimping device when the support body supports the implantable prosthetic valve within the channel.
  • Example 74 The support body of any example herein, particularly any one of examples 70-73, wherein the support body is configured to maintain one or more leaflets of the implantable prosthetic valve in an open position while the support body supports the implantable prosthetic valve within the channel.
  • Example 75 The support body of any example herein, particularly any one of examples 70-74, wherein the device engagement mechanism is configured to maintain the implantable prosthetic valve at a predetermined axial position relative to the coupling portion when the implantable prosthetic valve is operatively coupled to the support body.
  • Example 76 The support body of any example herein, particularly any one of examples 70-75, wherein the device engagement mechanism is configured to selectively restrict the implantable prosthetic valve from translating axially relative to the support body when the implantable prosthetic valve is operatively coupled to the support body.
  • Example 77 The support body of any example herein, particularly any one of examples 70-76, wherein the support portion extends away from the coupling portion along a longitudinal direction of a central axis of the support body, and wherein the device engagement mechanism is configured to engage the implantable prosthetic valve at one or more device engagement locations that are radially distal to the central axis relative to a portion of the ramped surface that is axially equidistant from the coupling portion, as measured along the longitudinal direction, compared to the one or more device engagement locations.
  • Example 78 The support body of any example herein, particularly any one of examples 70-77, wherein the implantable prosthetic valve comprises an annular frame defining a frame central passage and a valve assembly positioned within the frame central passage, and wherein the device engagement mechanism is configured to support the implantable prosthetic valve such that the annular frame is spaced apart from the ramped surface.
  • Example 79 The support body of any example herein, particularly any one of examples 70-78, wherein the device engagement mechanism comprises a plurality of circumferentially spaced apart legs configured to collectively support the implantable prosthetic valve.
  • Example 80 The support body of any example herein, particularly example 79, wherein each leg extends between and comprises an attached end that is fixed in position relative to the coupling portion and a free end configured to move radially relative to a central axis of the support body.
  • Example 81 The support body of any example herein, particularly example 80, wherein the attached end of each leg is directly coupled to the coupling portion.
  • Example 82 The support body of any example herein, particularly any one of examples 80-81 , wherein the attached end of each leg is directly coupled to the ramped surface.
  • Example 83 The support body of any example herein, particularly any one of examples 80-82, wherein each leg comprises a retention feature positioned proximate to the free end, wherein the retention feature is configured to extend at least partially through a portion of the implantable prosthetic valve to restrict axial translation of the implantable prosthetic valve relative to the support body when the implantable prosthetic valve is operatively coupled to the support body.
  • Example 84 The support body of any example herein, particularly example 83, wherein each retention feature defines one or more respective device engagement locations that are radially distal to the central axis relative to a portion of the ramped surface that is axially equidistant from the coupling portion, as measured along a longitudinal direction of the central axis, compared to the retention feature.
  • Example 85 The support body of any example herein, particularly any one of examples 83-84, wherein the retention features are configured to engage the implantable prosthetic valve such that a central axis of the implantable prosthetic valve is at least substantially aligned with a central axis of the support body when the implantable prosthetic valve is operatively coupled to the support body.
  • Example 86 The support body of any example herein, particularly any one of examples 83-85, wherein each retention feature comprises one or more of a hook, a latch, or a protrusion.
  • Example 87 The support body of any example herein, particularly any one of examples 79-86, wherein each leg comprises a stop element positioned between the attached end and the free end, wherein the stop element is configured to abut a portion of the implantable prosthetic valve to restrict translation of the implantable prosthetic valve relative to the support body in a proximal direction when the implantable prosthetic valve is operatively coupled to the support body.
  • Example 88 The support body of any example herein, particularly example 87, wherein each stop element defines a respective device engagement location that is radially distal to a central axis of the support body relative to a portion of the ramped surface that is axially equidistant from the coupling portion, as measured along a longitudinal direction of the central axis, compared to the stop element.
  • Example 89 The support body of any example herein, particularly any one of examples 87-88, wherein each stop element comprises a surface extending at least substantially perpendicular to a central axis of the support body.
  • Example 90 The support body of any example herein, particularly any one of examples 70-89, wherein the device engagement mechanism is configured to transition between an engaged configuration, in which the device engagement mechanism is positioned to engage the implantable prosthetic valve, and a disengaged configuration, in which the device engagement mechanism is positioned such that the implantable prosthetic valve may be axially moved relative to the support body.
  • Example 91 The support body of any example herein, particularly example 90, wherein the device engagement mechanism is biased toward the engaged configuration.
  • Example 92 The support body of any example herein, particularly any one of examples 90-91, wherein the device engagement mechanism is configured to transition from the engaged configuration to the disengaged configuration responsive to the valve crimping device urging the device engagement mechanism radially inward.
  • Example 93 The support body of any example herein, particularly any one of examples 90-92, wherein the device engagement mechanism comprises a plurality of legs configured to deflect radially inward to transition the device engagement mechanism from the engaged configuration to the disengaged configuration.
  • Example 94 The support body of any example herein, particularly example 93, wherein the ramped surface defines a plurality of cut-outs, wherein each leg is circumferentially aligned with a corresponding cut-out of the plurality of cut-outs, and wherein, when the device engagement mechanism is in the disengaged configuration, each leg is at least partially received within the corresponding cut-out.
  • Example 95 The support body of any example herein, particularly any one of examples 70-94, wherein the support portion comprises one or more rotational alignment indicators proximate to an end region of the support portion.
  • Example 96 The support body of any example herein, particularly example 95, wherein each rotational alignment indicator comprises one or more of a raised region, a depressed region, and a printed indicator.
  • Example 97 The support body of any example herein, particularly any one of examples 95-96, wherein the device engagement mechanism comprises a plurality of circumferentially spaced apart legs configured to collectively support the implantable prosthetic valve, and wherein each rotational alignment indicator is circumferentially aligned with a corresponding leg.
  • Example 98 The support body of any example herein, particularly any one of examples 70-97, wherein the valve crimping device comprises a proximal side portion with a proximal opening that leads into the channel, wherein the proximal side portion comprises a support body coupling structure, and wherein the coupling portion comprises an alignment structure configured to engage the support body coupling structure to operatively couple the support body to the valve crimping device.
  • Example 99 The support body of any example herein, particularly example 98, wherein the alignment structure is configured to engage the support body coupling structure in one of a finite number of predetermined rotational orientations.
  • Example 100 The support body of any example herein, particularly any one of examples 98-99, wherein the support body coupling structure is configured to receive at least a portion of the alignment structure when the support body is operatively coupled to the valve crimping device.
  • Example 101 The support body of any example herein, particularly any one of examples 98-100, wherein the alignment structure comprises one or more radial projections extending radially away from a coupling portion body of the coupling portion, and wherein the support body coupling structure comprises one or more slots configured to receive the one or more radial projections.
  • Example 102 The support body of any example herein, particularly any one of examples 98-101, wherein the coupling portion comprises a crimping device catch mechanism configured to engage the proximal side portion to restrict the support body from being removed from the valve crimping device when the support body is operatively coupled to the valve crimping device.
  • the coupling portion comprises a crimping device catch mechanism configured to engage the proximal side portion to restrict the support body from being removed from the valve crimping device when the support body is operatively coupled to the valve crimping device.
  • Example 103 The support body of any example herein, particularly example 102, wherein the support body coupling structure comprises one or more slots configured to receive the one or more radial projections, and wherein the crimping device catch mechanism comprises one or more protrusions configured to engage one or more corresponding engagement arms of the proximal side portion that collectively define the slots therebetween.
  • Example 104 The support body of any example herein, particularly example 103, wherein the crimping device catch mechanism is configured such that, when the support body is operatively coupled to the valve crimping device, each protrusion is positioned within a recess defined on a distal side of the corresponding engagement arm.
  • Example 105 The support body of any example herein, particularly any one of examples 103-104, wherein the crimping device catch mechanism comprises one or more retaining members, each supporting a corresponding protrusion of the one or more protrusions, and wherein each retaining member is configured to deflect to move the corresponding protrusion radially inward to allow the support body to be removed from the valve crimping device when the support body is urged in a proximal direction with a force in excess of a threshold force by the valve crimping device.
  • Example 106 A mounting assembly comprising: a valve crimping device configured to crimp an implantable prosthetic valve around a valve delivery apparatus, the valve crimping device comprising a channel having a variable channel diameter and being configured to receive each of the implantable prosthetic valve and a valve mounting portion of the valve delivery apparatus therein; and the support body of any example herein, particularly any one of examples 70-105.
  • Example 107 The mounting assembly of any example herein, particularly example 106, wherein the valve crimping device is the valve crimping deice of any example herein, particularly any one of examples 1-31.
  • Example 108 A method of mounting an implantable prosthetic valve to a valve delivery apparatus, the method comprising: with a valve crimping device in an open configuration, operatively coupling a support body on which the implantable prosthetic valve is mounted to a proximal side portion of the valve crimping device to position the implantable prosthetic valve within a channel of the valve crimping device; transitioning the valve crimping device to an intermediate configuration, in which the valve crimping device supports the implantable prosthetic valve within the channel; removing the support body from the valve crimping device; operatively coupling a positioning device to the proximal side portion of the valve crimping device; mounting the valve delivery apparatus to the positioning device to position the valve delivery apparatus within the channel; and transitioning the valve crimping device to a crimped configuration, in which the valve crimping device crimps the implantable prosthetic valve onto a valve mounting portion of the valve delivery apparatus.
  • Example 109 The method of any example herein, particularly example 108, wherein the operatively coupling the positioning device to the proximal side portion is performed subsequent to the removing the support body from the valve crimping device.
  • Example 110 The method of any example herein, particularly any one of examples 108-109, wherein the operatively coupling the support body to the proximal side portion comprises inserting the implantable prosthetic valve into the channel via the proximal side portion.
  • Example 111 The method of any example herein, particularly any one of examples 108-110, wherein the operatively coupling the positioning device to the proximal side portion comprises coupling such that the valve delivery apparatus is inserted into the channel via the proximal side portion.
  • Example 112 The method of any example herein, particularly any one of examples 108-111, wherein the mounting the valve delivery apparatus to the positioning device comprises positioning the valve delivery apparatus within the channel such that the valve mounting portion is positioned radially interior of the implantable prosthetic valve supported within the channel.
  • Example 113 The method of any example herein, particularly any one of examples 108-112, wherein the valve crimping device comprises a handle configured to be manually actuated to rotate a rotatable body of the valve crimping device relative to a base of the valve crimping device, and wherein each of the transitioning the valve crimping device to the intermediate configuration and the transitioning the valve crimping device to the crimped configuration comprises actuating the handle in a first direction.
  • Example 114 The method of any example herein, particularly any one of examples 108-113, wherein each of the removing the support body from the valve crimping device and the operatively coupling the positioning device to the proximal side portion is performed while the valve crimping device is in the intermediate configuration.
  • Example 115 The method of any example herein, particularly any one of examples 108-114, further comprising retaining the valve crimping device in the intermediate configuration during one or both of the removing the support body from the valve crimping device and the operatively coupling the positioning device to the proximal side portion.
  • Example 116 The method of any example herein, particularly example 115, wherein the retaining the valve crimping device in the intermediate configuration comprises activating a crimp brake mechanism of the valve crimping device.
  • Example 117 The method of any example herein, particularly example 116, wherein the valve crimping device comprises a handle configured to be manually actuated to rotate a rotatable body of the valve crimping device relative to a base of the valve crimping device, and wherein the activating the crimp brake mechanism comprises mechanically engaging the rotatable body with the crimp brake mechanism to restrict rotation of the rotatable body relative to the base.
  • Example 118 The method of any example herein, particularly example 117, wherein the crimp brake mechanism comprises a catch unit that mechanically engages the rotatable body when the valve crimping device is in the intermediate configuration, wherein one of the catch unit or the rotatable body comprises a locking tab, wherein the other of the catch unit or the rotatable body comprises a tab receiver that receives the locking tab to restrict rotation of the rotatable body when the valve crimping device is in the intermediate configuration, and wherein the mechanically engaging the rotatable body comprises inserting the locking tab into the tab receiver.
  • Example 119 The method of any example herein, particularly example 118, wherein the inserting the locking tab into the tab receiver is performed automatically when the valve crimping device reaches the intermediate configuration.
  • Example 121 The method of any example herein, particularly example 120, wherein the crimp brake mechanism comprises a catch unit that mechanically engages a rotatable body of the valve crimping device when the valve crimping device is in the intermediate configuration, wherein one of the catch unit or the rotatable body comprises a locking tab, wherein the other of the catch unit or the rotatable body comprises a tab receiver that receives the locking tab to restrict rotation of the rotatable body when the valve crimping device is in the intermediate configuration, and wherein the deactivating the crimp brake mechanism comprises removing the locking tab from the tab receiver.
  • Example 122 The method of any example herein, particularly example 121, wherein the catch unit comprises a tab removal grip feature configured to facilitate removal of the locking tab from the tab receiver, and wherein the removing the locking tab from the tab receiver comprises manually actuating the tab removal grip feature.
  • Example 123 The method of any example herein, particularly any one of examples 121-122, wherein the valve crimping device comprises a handle configured to be manually actuated to rotate a rotatable body of the valve crimping device relative to a base of the valve crimping device, and wherein the deactivating the crimp brake mechanism comprises applying a torque to the handle that exceeds a threshold torque.
  • Example 126 The method of any example herein, particularly any one of examples 108-125, wherein the support body comprises a support portion configured to support the implantable prosthetic valve and a coupling portion configured to be coupled to the valve crimping device, wherein the proximal side portion comprises a support body coupling structure, wherein the coupling portion comprises an alignment structure configured to engage the support body coupling structure to operatively couple the support body to the valve crimping device, and wherein the operatively coupling the support body to the proximal side portion comprises engaging the support body coupling portion with the alignment structure.
  • Example 127 The method of any example herein, particularly example 126, wherein the alignment structure comprises one or more radial projections extending radially away from a coupling portion body of the coupling portion, wherein the support body coupling structure comprises one or more slots configured to receive the one or more radial projections, wherein the coupling portion comprises a crimping device catch mechanism configured to engage the proximal side portion to restrict the support body from being removed from the valve crimping device when the support body is operatively coupled to the valve crimping device, wherein the crimping device catch mechanism comprises one or more protrusions configured to engage one or more corresponding engagement arms of the proximal side portion that collectively define the slots therebetween, and wherein the engaging the support body coupling portion with the alignment structure comprises positioning each protrusion within a recess defined on a distal side of the corresponding engagement arm.
  • Example 128 The method of any example herein, particularly example 127, wherein the removing the support body from the valve crimping device comprises exerting a force on the support body in a proximal direction in excess of a threshold force at which each protrusion is urged out of obstruction with the corresponding engagement arm to permit the support body to translate axially relative to the engagement arms.
  • Example 129 The method of any example herein, particularly any one of examples 108-128, wherein the operatively coupling the support body to the proximal side portion comprises axially translating the support body toward the proximal side portion, and wherein the removing the support body from the valve crimping device comprises axially translating the support body away from the proximal side portion.
  • Example 130 The method of any example herein, particularly any one of examples 108-129, wherein the positioning device comprises a crimping device coupling structure configured to operatively couple the positioning device to the crimping device, wherein the proximal side portion of the crimping device comprises a positioning device coupling structure, wherein the crimping device coupling structure comprises a flange portion with one or more mating elements configured to engage the positioning device coupling structure to operatively couple the positioning device to the crimping device, and wherein the operatively coupling the positioning device to the proximal side portion comprises engaging the positioning device coupling structure with the one or more mating elements.
  • Example 131 The method of any example herein, particularly any one of examples 108-130, wherein the operatively coupling the positioning device to the proximal side portion comprises rotating the positioning device relative to the proximal side portion in a first coupling direction.
  • Example 132 The method of any example herein, particularly example 131, further comprising removing the positioning device from the proximal side portion, wherein the removing the positioning device from the proximal side portion comprises rotating the positioning device relative to the proximal side portion in a second coupling direction opposite the first coupling direction.
  • Example 134 The method of any example herein, particularly example 133, wherein the support body comprises a support portion configured to support the implantable prosthetic valve and a coupling portion configured to be coupled to the valve crimping device, and wherein the mounting the implantable prosthetic valve on the support body comprises inserting the support portion within an annular frame of the implantable prosthetic valve such that one or more leaflets of the implantable prosthetic valve are maintained in an open position.
  • Example 136 The method of any example herein, particularly any one of examples 133-135, wherein the support body comprises a device engagement mechanism configured to engage the implantable prosthetic valve to at least partially support the implantable prosthetic valve within the channel when the support body is positioned within the channel, and wherein the mounting the implantable prosthetic valve on the support body comprises engaging the implantable prosthetic valve with the device engagement mechanism.
  • Example 137 The method of any example herein, particularly example 136, wherein the mounting the implantable prosthetic valve on the support body comprises inserting the support body within an annular frame of the implantable prosthetic valve such that the device engagement mechanism extends at least partially within the annular frame.
  • Example 138 The method of any example herein, particularly any one of examples 136-137, wherein the device engagement mechanism comprises one or more stop elements configured to abut a portion of the implantable prosthetic valve to restrict translation of the implantable prosthetic valve relative to the support body in a proximal direction when the implantable prosthetic valve is operatively coupled to the support body, and wherein the mounting the implantable prosthetic valve on the support body comprises moving the implantable prosthetic valve in the proximal direction relative to the support body until the one or more stop elements engage the implantable prosthetic valve.
  • the device engagement mechanism comprises one or more stop elements configured to abut a portion of the implantable prosthetic valve to restrict translation of the implantable prosthetic valve relative to the support body in a proximal direction when the implantable prosthetic valve is operatively coupled to the support body
  • the mounting the implantable prosthetic valve on the support body comprises moving the implantable prosthetic valve in the proximal direction relative to the support body until the one or more stop elements engage the implantable prosthetic valve.
  • Example 139 The method of any example herein, particularly any one of examples 136-138, wherein the device engagement mechanism comprises a plurality of circumferentially spaced apart legs configured to collectively support the implantable prosthetic valve, wherein each leg comprises a retention feature, and wherein the mounting the implantable prosthetic valve on the support body comprises positioning the implantable prosthetic valve such that each leg extends at least partially through a portion of the implantable prosthetic valve to restrict axial translation of the implantable prosthetic valve relative to the support body.
  • the device engagement mechanism comprises a plurality of circumferentially spaced apart legs configured to collectively support the implantable prosthetic valve, wherein each leg comprises a retention feature
  • the mounting the implantable prosthetic valve on the support body comprises positioning the implantable prosthetic valve such that each leg extends at least partially through a portion of the implantable prosthetic valve to restrict axial translation of the implantable prosthetic valve relative to the support body.
  • Example 141 The method of any example herein, particularly example 140, wherein the deflecting the legs is performed automatically responsive to a radially directed force exerted upon each retention feature by the implantable prosthetic valve.
  • Example 142 The method of any example herein, particularly any one of examples 136-142, further comprising, prior to the removing the support body from the valve crimping device, disengaging the device engagement mechanism from the implantable prosthetic valve.
  • Example 144 The method of any example herein, particularly example 143, wherein the transitioning the device engagement mechanism to the disengaged configuration is performed automatically responsive to the transitioning the valve crimping device to the intermediate configuration.
  • Example 145 The method of any example herein, particularly any one of examples 136-144, wherein the device engagement mechanism comprises a plurality of circumferentially spaced apart legs, each comprising a retention feature configured to engage the implantable prosthetic valve to restrict axial translation of the implantable prosthetic valve when the implantable prosthetic valve is operatively coupled to the support body, and wherein the disengaging the device engagement mechanism comprises moving the legs relative to the implantable prosthetic valve such that each retention feature no longer restricts axial translation of the implantable prosthetic valve.
  • Example 146 The method of any example herein, particularly example 145, wherein the moving the legs comprises deflecting the legs radially inward with pressing surfaces of the valve crimping device.
  • Example 147 The method of any example herein, particularly any one of examples 133-146, wherein the support portion comprises one or more rotational alignment indicators proximate to an end region of the support portion, and wherein the mounting the implantable prosthetic valve on the support body comprises aligning each rotational alignment indicator with a commissure of the implantable prosthetic valve.
  • Example 148 The method of any example herein, particularly any one of examples 133-147, further comprising, prior to the mounting the implantable prosthetic valve on the support body, operatively coupling a ring body to the support body, and wherein the mounting the implantable prosthetic valve on the support body comprises engaging a valve engagement surface of the ring body with a portion of the implantable prosthetic valve.
  • Example 149 The method of any example herein, particularly example 148, further comprising, prior to the operatively coupling the support body to the proximal side portion, removing the ring body from the support body.
  • Example 150 The method of any example herein, particularly any one of examples 108-149, wherein the removing the support body from the valve crimping device is performed while the implantable prosthetic valve is supported within the channel.
  • Example 151 The method of any example herein, particularly any one of examples 108-150, wherein the operatively coupling the positioning device to the proximal side portion is performed while the implantable prosthetic valve is supported within the channel.
  • Example 152 The method of any example herein, particularly any one of examples 108-151, wherein the positioning device comprises a body comprising a first portion and a second portion joined at a hinge and defining a central channel therebetween, and wherein the mounting the valve delivery apparatus to the positioning device comprises pivoting the first portion toward the second portion to retain one or more shafts of the valve delivery apparatus within the central channel.
  • Example 153 The method of any example herein, particularly any one of examples 108-152, wherein the valve crimping device is the valve crimping device of any example herein, particularly any one of examples 1-31.
  • Example 154 The method of any example herein, particularly any one of examples 108-153, wherein the support body is the support body of any example herein, particularly any one of examples 32-60 or any one of examples 70-105.
  • Example 155 The method of any example herein, particularly any one of examples 108-154, wherein the implantable prosthetic valve is the implantable prosthetic valve of any example herein, particularly any one of examples 61-69.
  • Example 156 The method of any example herein, particularly any one of examples 108-155, wherein the positioning device is the positioning device of any example herein, particularly any one of examples 53-60.
  • Example 157 The method of any example herein, particularly any one of examples 108-156, wherein the valve delivery apparatus is the valve delivery apparatus of any example herein, particularly any one of examples 61-69.
  • Example 158 A method comprising: with a valve crimping device in an open configuration, operatively coupling a support body on which an implantable prosthetic valve is mounted to a proximal side portion of the valve crimping device to position the implantable prosthetic valve within a channel of the valve crimping device; transitioning the valve crimping device to an intermediate configuration, in which the valve crimping device supports the implantable prosthetic valve within the channel; and removing the support body from the valve crimping device such that the implantable prosthetic valve remains supported within the channel.
  • Example 159 The method of any example herein, particularly example 158, further comprising retaining the valve crimping device in the intermediate configuration during the removing the support body from the valve crimping device.
  • Example 160 The method of any example herein, particularly example 159, wherein the retaining the valve crimping device in the intermediate configuration comprises activating a crimp brake mechanism of the valve crimping device.
  • Example 161 The method of any example herein, particularly example 160, wherein the valve crimping device comprises a handle configured to be manually actuated to rotate a rotatable body of the valve crimping device relative to a base of the valve crimping device, and wherein the activating the crimp brake mechanism comprises mechanically engaging the rotatable body with the crimp brake mechanism to restrict rotation of the rotatable body relative to the base.
  • Example 162 The method of any example herein, particularly any one of examples 158-161, further comprising: positioning a valve delivery apparatus within the channel; and transitioning the valve crimping device to a crimped configuration, in which the valve crimping device crimps the implantable prosthetic valve onto a valve mounting portion of the valve delivery apparatus.
  • Example 163 The method of any example herein, particularly example 162, wherein the positioning the valve delivery apparatus within the channel comprises mounting the valve delivery apparatus to a positioning device that is operatively coupled to the proximal side portion of the valve crimping device.
  • Example 164 The method of any example herein, particularly example 163, further comprising, subsequent to the removing the support body form the valve crimping device, operatively coupling the positioning device to the proximal side portion of the valve crimping device.
  • Example 165 The method of any example herein, particularly any one of examples 158-164, wherein the valve crimping device is the valve crimping device of any example herein, particularly any one of examples 1-31.
  • Example 166 The method of any example herein, particularly any one of examples 158-165, wherein the support body is the support body of any example herein, particularly any one of examples 32-60 or any one of examples 70-105.
  • Example 167 The method of any example herein, particularly any one of examples 158-166, wherein the implantable prosthetic valve is the implantable prosthetic valve of any example herein, particularly any one of examples 61-69.
  • Example 168 The method of any example herein, particularly any one of examples 163-167, wherein the positioning device is the positioning device of any example herein, particularly any one of examples 53-60.
  • Example 169 The method of any example herein, particularly any one of examples 162-168, wherein the valve delivery apparatus is the valve delivery apparatus of any example herein, particularly any one of examples 61-69.
  • Example 170 The apparatus of any example herein, wherein the apparatus is sterilized.
  • Example 17 The method of any example herein, further comprising sterilizing the apparatus of any example herein.

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

Un dispositif de sertissage de valve peut comprendre une poignée et un mécanisme de frein de sertissage conçu pour retenir au moins partiellement la poignée dans une position intermédiaire tandis qu'une prothèse valvulaire implantable est sertie autour d'un appareil de pose de valve. Un ensemble de fixation peut comprendre un dispositif de sertissage de valve, un corps de support et un dispositif de positionnement. Le corps de support et le dispositif de positionnement peuvent chacun être conçus pour être couplés de manière fonctionnelle à une partie latérale proximale du dispositif de sertissage de valve. Un ensemble de préparation de prothèse valvulaire peut comprendre une prothèse valvulaire implantable, un appareil de pose de valve et un dispositif de sertissage de valve pour sertir la prothèse valvulaire implantable autour d'une partie de l'appareil de pose de valve. Une méthode peut consister à retirer un corps de support d'un côté proximal d'un dispositif de sertissage de valve tandis que le dispositif de sertissage de valve est retenu dans une configuration intermédiaire.
PCT/US2025/011246 2024-01-11 2025-01-10 Ensembles de fixation de prothèse valvulaire et méthodes associées Pending WO2025151823A1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US202463619852P 2024-01-11 2024-01-11
US63/619,852 2024-01-11
US202463722570P 2024-11-19 2024-11-19
US63/722,570 2024-11-19

Publications (1)

Publication Number Publication Date
WO2025151823A1 true WO2025151823A1 (fr) 2025-07-17

Family

ID=94605759

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2025/011246 Pending WO2025151823A1 (fr) 2024-01-11 2025-01-10 Ensembles de fixation de prothèse valvulaire et méthodes associées

Country Status (1)

Country Link
WO (1) WO2025151823A1 (fr)

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7530253B2 (en) 2005-09-09 2009-05-12 Edwards Lifesciences Corporation Prosthetic valve crimping device
US9061119B2 (en) 2008-05-09 2015-06-23 Edwards Lifesciences Corporation Low profile delivery system for transcatheter heart valve
US9339384B2 (en) 2011-07-27 2016-05-17 Edwards Lifesciences Corporation Delivery systems for prosthetic heart valve
WO2022046588A1 (fr) * 2020-08-24 2022-03-03 Edwards Lifesciences Corporation Marqueur de commissure pour valve cardiaque prothétique
US20230218415A1 (en) * 2020-08-31 2023-07-13 Edwards Lifesciences Corporation Systems and methods for crimping and device preparation

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7530253B2 (en) 2005-09-09 2009-05-12 Edwards Lifesciences Corporation Prosthetic valve crimping device
US9061119B2 (en) 2008-05-09 2015-06-23 Edwards Lifesciences Corporation Low profile delivery system for transcatheter heart valve
US9339384B2 (en) 2011-07-27 2016-05-17 Edwards Lifesciences Corporation Delivery systems for prosthetic heart valve
WO2022046588A1 (fr) * 2020-08-24 2022-03-03 Edwards Lifesciences Corporation Marqueur de commissure pour valve cardiaque prothétique
US20230218415A1 (en) * 2020-08-31 2023-07-13 Edwards Lifesciences Corporation Systems and methods for crimping and device preparation

Similar Documents

Publication Publication Date Title
US20250295491A1 (en) Devices and methods for crimping prosthetic implants
CA3004602A1 (fr) Appareil de pose controlee de valve cardiaque
US20250143900A1 (en) Prosthetic valve preparation assemblies and associated methods
EP4608339A1 (fr) Cathéter de guidage pour appareil de pose d'implant
US20250312177A1 (en) Mounting assembly for crimping a prosthetic valve
US20250248801A1 (en) Methods and systems for packaging and preparing a prosthetic valve delivery system
WO2025151823A1 (fr) Ensembles de fixation de prothèse valvulaire et méthodes associées
WO2025042676A1 (fr) Dispositif d'alignement pour implant prothétique
WO2025231282A1 (fr) Procédure de sertissage de valve automatisée
EP4493120A1 (fr) Appareil de pose pour une valvule cardiaque prothétique à expansion mécanique
US20250195218A1 (en) Delivery apparatus for a prosthetic device
US20250387225A1 (en) Prosthetic medical device delivery apparatus
US20250318941A1 (en) Apparatus and methods for locking a prosthetic implant delivery apparatus
HK40077216A (en) Device and method for crimping prosthetic implants
WO2025230908A1 (fr) Appareil de pose d'implants prothétiques
WO2025128418A1 (fr) Systèmes, dispositifs et procédés de traitement de valvules cardiaques
WO2025064615A1 (fr) Dispositif de pose à ancrage de fil de traction robuste
WO2025221516A2 (fr) Outils d'alignement d'implants prothétiques
WO2024186723A1 (fr) Appareil de pose de dispositif médical prothétique
CN118717363A (zh) 输送器及输送系统
AU2023288436A1 (en) Suture lock assembly with a suture tensioner

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 25705385

Country of ref document: EP

Kind code of ref document: A1