Apparatus and method for shortening a prosthetic implant - Patent Application 20070122997

Abstract

To provide devices, systems and related methods for crimping a prosthetic implant onto a delivery apparatus, which can be used to deliver the crimped prosthetic implant to a deployment site within a body of a subject.SOLUTION: An assembly includes a holder device and a non-self-expandable prosthetic heart valve. The prosthetic heart valve can be radially compressed from an expanded configuration to a compressed configuration. The holder device is configured to hold the prosthetic heart valve in the expanded configuration and to allow the prosthetic heart valve to be inserted in a crimping device so that the prosthetic heart valve can be crimped onto a valve mounting portion of a delivery apparatus.SELECTED DRAWING: Figure 2

Description

[Technical Field]

[0001] TECHNICAL FIELD This application relates generally to devices and related methods for shortening prosthetic implants, such as prosthetic heart valves. [Background technology]

[0002] The human heart can suffer from a variety of valvular diseases. These valvular diseases can lead to significant cardiac dysfunction and ultimately require replacement of the natural valve with an artificial valve. There are several known prosthetic valves and several known methods for implanting these prosthetic valves in humans. Due to the drawbacks associated with traditional open-heart surgery, percutaneous, minimally invasive surgical techniques have attracted significant attention. In one technique, prosthetic heart valves are configured to be implanted using catheter techniques, a much less invasive procedure. For example, a collapsible transcatheter prosthetic heart valve can be compressed or crimped, introduced percutaneously in a compressed state with a delivery device, and expanded to a functional size at the desired location.

[0003] Such transcatheter prosthetic valves may be self-expandable or balloon-expandable. Balloon-expandable prosthetic valves are typically crimped from an initial large diameter to a smaller diameter before being advanced to a treatment site in the body. Before crimping, the balloon-expandable prosthetic valve is typically placed on an inflatable balloon on the catheter shaft. Once delivered to the implantation site, the balloon can be inflated to expand the prosthetic valve to its functional size. Self-expanding prosthetic valves are typically crimped to a smaller diameter before being inserted into a sheath. After placement in the body, the sheath is retracted and the prosthetic valve expands within the body. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] U.S. Patent No. 9,393,110 [Patent Document 2] U.S. Patent No. 8,449,599 [Patent Document 3] U.S. Patent No. 7,999,394 [Patent Document 4] U.S. Patent No. 7,510,575 [Patent Document 5] US Patent Application Publication No. 2016 / 0317301 [Patent Document 6] U.S. Patent Application Serial No. 15 / 664,430 [Patent Document 7] U.S. Patent No. 9,339,384 [Patent Document 8] US Patent Application Publication No. 2017 / 0065415 [Patent Document 9] US Patent Application Publication No. 2015 / 0336150 [Patent Document 10] US Patent Application Publication No. 2015 / 0190225 [Patent Document 11] US Patent Application Publication No. 2013 / 0030418 [Patent Document 12] U.S. Patent No. 7,993,394 [Patent Document 13] U.S. Patent No. 8,007,992 [Patent Document 14] US Patent Publication No. 2009 / 0164005 Summary of the Invention [Means for solving the problem]

[0005] Disclosed herein are exemplary embodiments of devices, systems, and associated methods for crimping a prosthetic implant in a delivery device that can be used to deliver the crimped prosthetic implant to a deployment site within a subject's body. In some implementations, the delivery device can be used to deliver the prosthetic implant through the vascular system, such as the subject's heart.

[0006] Certain embodiments of the present disclosure relate to an assembly including a retention device and a non-self-expandable prosthetic heart valve, the prosthetic heart valve being radially compressible from an expanded configuration to a compressed configuration, the retention device being configured to retain the prosthetic heart valve in the expanded configuration and to allow the prosthetic heart valve to be inserted into the crimping device so that the prosthetic heart valve can be crimped onto the valve-seating portion of the delivery device.

[0007] In some embodiments, the retention device may include one or more retention members configured to secure the prosthetic heart valve to the retention device when the prosthetic heart valve is in an expanded configuration and configured to release the prosthetic heart valve from the retention device when the prosthetic heart valve is compressed from the expanded configuration to a compressed configuration in the valve mounting portion of the delivery device.

[0008] In some embodiments, a distal portion of each retention member can extend distally into the prosthetic heart valve when the prosthetic heart valve is in the expanded configuration, and a distal portion of each retention member can be disposed proximal to the prosthetic heart valve when the prosthetic heart valve is in the compressed configuration.

[0009] In some embodiments, each of the retention members can have a protrusion extending radially outward at a distal end of the retention member, and each protrusion can be configured to extend radially outward into an opening in the prosthetic heart valve when the prosthetic heart valve is in the expanded configuration.

[0010] In some embodiments, the retention device can include a first portion and a second portion, and one or more retention members can extend distally from the second portion and can be axially movable relative to a distal surface of the first portion.

[0011] In some embodiments, the prosthetic heart valve can elongate in one direction when the prosthetic heart valve is contracted from the expanded configuration to the compressed configuration, such that the distal face of the first portion prevents the prosthetic heart valve from elongating proximally while allowing the prosthetic heart valve to elongate distally.

[0012] In some embodiments, the retention member can be configured to extend distally relative to the distal surface of the first portion to couple to the prosthetic heart valve in the expanded configuration, and can be configured to move proximally relative to the distal surface of the first portion after releasing the prosthetic heart valve when the prosthetic heart valve is radially compressed.

[0013] In some embodiments, when the prosthetic heart valve is held by the retention device, a proximal end portion of the prosthetic heart valve can abut against a distal surface of the first portion when the prosthetic heart valve is in an expanded configuration and secured to the retention device by the retention member.

[0014] In some embodiments, the second portion of the retention device may include one or more angled protrusions corresponding to one or more retention members, each angled protrusion being able to abut against an angled member on a corresponding retention member such that the retention member can slide distally into the interior space of the prosthetic heart valve when the prosthetic heart valve is in the expanded configuration.

[0015] In some embodiments, the retaining device may include one or more biasing members configured to bias the second portion proximally relative to the first portion.

[0016] In some embodiments, the second portion may include one or more arms, the distal end of each of which may extend distally relative to the distal face of the first portion when the retention member is coupled to the prosthetic heart valve.

[0017] In some embodiments, at least one arm can be circumferentially disposed between a pair of adjacent retention members. The retention members can extend radially outward relative to the arms when the prosthetic heart valve is in the expanded configuration. The retention members can be compressed radially inward and radially aligned with at least a portion of the arms when the prosthetic heart valve is radially compressed.

[0018] In some embodiments, the distal end of each arm may include an inclined surface configured to interface with the retraction jaw such that radially inward movement of the retraction jaw can exert a force on the inclined surface, urging the corresponding arm to move proximally relative to the first portion.

[0019] In some embodiments, the assembly may further include a positioning device configured to be releasably coupled to the shaft of the delivery device and to be releasably coupled to the retention device.

[0020] In some embodiments, the positioning device can include a body having an inner surface defining an axially extending passageway sized to form an interference fit with a portion of the shaft.

[0021] In some embodiments, a portion of the shaft can be positioned distally at a predetermined distance relative to the valve mounting portion.

[0022] In some embodiments, the inner surface of the body may include an array of circumferentially oriented grooves extending from the proximal end of the body to the distal end of the body such that sterilizing gas can permeate through the grooves and into the passageway when the body is coupled to the shaft.

[0023] In some embodiments, the retaining device may include one or more first coupling members mateable with one or more second coupling members of the positioning device.

[0024] In some embodiments, the assembly may further comprise a retraction device. The retraction device may be configured to radially compress the prosthetic heart valve from the expanded configuration to the compressed configuration. The retention device may comprise one or more third coupling members mateable with one or more fourth coupling members of the retraction device.

[0025] Certain embodiments of the present disclosure also relate to a system for prosthetic heart valve implantation, which may include a positioning and holding assembly configured to retain the prosthetic heart valve in an expanded configuration and mounted on the shaft of a delivery device to allow insertion of the prosthetic heart valve into a crimping device to crimp the prosthetic heart valve in a valve mounting portion of the delivery device from a radially expanded configuration to a radially compressed configuration.

[0026] In some embodiments, the positioning and holding assembly may include a positioning portion configured to be releasably coupled to the shaft of the delivery device, and a holding portion configured to releasably hold the prosthetic heart valve in a radially expanded configuration while the prosthetic heart valve is contracted in the valve mounting portion of the delivery device.

[0027] In some embodiments, the positioning portion and the retaining portion may be separable from one another.

[0028] In some embodiments, the positioning portion and the retaining portion may be non-separable from one another.

[0029] In some embodiments, the retaining portion may include one or more retention members configured to secure the prosthetic heart valve to the retaining portion when the prosthetic heart valve is in an expanded configuration and configured to release the prosthetic heart valve from the retaining portion when the prosthetic heart valve is contracted from the expanded configuration to a compressed configuration in the valve mounting portion of the delivery device.

[0030] In some embodiments, a distal portion of each retention member can extend distally into the prosthetic heart valve when the prosthetic heart valve is in the expanded configuration, and a distal portion of each retention member can be disposed proximal to the prosthetic heart valve when the prosthetic heart valve is in the compressed configuration.

[0031] In some embodiments, each of the retention members can have a protrusion extending radially outward at a distal end of the retention member, and each protrusion can be configured to extend radially outward into an opening in the prosthetic heart valve when the prosthetic heart valve is in the expanded configuration.

[0032] In some embodiments, the retention portion can include a first portion and a second portion, and one or more retention members can extend distally from the second portion and can be axially movable relative to a distal surface of the first portion.

[0033] In some embodiments, the distal surface of the first portion prevents the prosthetic heart valve from elongating proximally. On the other hand, the prosthetic heart valve can elongate in one direction when the prosthetic heart valve is contracted from the expanded configuration to the compressed configuration, such that the prosthetic heart valve can elongate distally.

[0034] In some embodiments, the plurality of retention members can be configured to extend distally relative to the distal surface of the first portion to couple to the prosthetic heart valve in the expanded configuration, and can be configured to move proximally relative to the distal surface of the first portion after releasing the prosthetic heart valve when the prosthetic heart valve is radially compressed.

[0035] In some embodiments, when the prosthetic heart valve is held by the holding portion, a proximal end portion of the prosthetic heart valve can abut against a distal surface of the first portion when the prosthetic heart valve is in an expanded configuration and secured to the holding portion by a plurality of retention members.

[0036] In some embodiments, the second portion may include a plurality of angled protrusions corresponding to the plurality of retention members, each of which may abut a angled member on a corresponding retention member such that the retention member can slide distally into the interior space of the prosthetic heart valve when the prosthetic heart valve is in the expanded configuration.

[0037] In some embodiments, the retaining portion may include one or more biasing members configured to bias the second portion proximally relative to the first portion.

[0038] In some embodiments, the second portion can include one or more arms, the distal end of each of which can extend distally relative to the distal face of the first portion when the retention member is coupled to the prosthetic heart valve.

[0039] In some embodiments, at least one arm can be circumferentially disposed between a pair of adjacent retention members. The retention members can extend radially outward relative to the arms when the prosthetic heart valve is in the expanded configuration. The retention members can be compressed radially inward and radially aligned with at least a portion of the arms when the prosthetic heart valve is radially compressed.

[0040] In some embodiments, the distal end of each arm may include an inclined surface configured to interface with a retraction jaw of the retraction device such that radially inward movement of the retraction jaw can exert a force on the inclined surface, urging the corresponding arm to move proximally relative to the first portion.

[0041] In some embodiments, the positioning portion may include a body having an inner surface defining an axially extending passageway sized to form an interference fit with a portion of the shaft.

[0042] In some embodiments, a portion of the shaft can be positioned distally at a predetermined distance relative to the valve mounting portion.

[0043] In some embodiments, the inner surface of the body may include an array of circumferentially oriented grooves extending from the proximal end of the body to the distal end of the body such that sterilizing gas can permeate through the grooves and into the passageway when the body is coupled to the shaft.

[0044] In some embodiments, the positioning and holding assembly may further comprise one or more coupling members mateable with one or more complementary coupling members of the retraction device.

[0045] Certain embodiments of the present disclosure further relate to a method for crimping a prosthetic heart valve in a delivery device, the method comprising coupling a crimping device to a positioning and holding assembly mounted on a shaft of the delivery device such that the prosthetic heart valve held by the positioning and holding assembly is inserted into the crimping device. and actuating a crimping device to radially compress the prosthetic heart valve in the valve mounting portion of the delivery device from an expanded configuration to a compressed configuration.

[0046] In some embodiments, the method may further include coupling the prosthetic heart valve in the expanded configuration to a positioning and holding assembly.

[0047] In some embodiments, the method may further include mounting the positioning and retaining assembly at a predetermined location on the shaft of the delivery device. The predetermined location may be spaced relative to the valve mounting portion of the delivery device.

[0048] In some embodiments, the positioning and holding assembly may include a positioning portion that is releasably coupled to the shaft of the delivery device and a holding portion that releasably retains the prosthetic heart valve.

[0049] In some embodiments, the act of attaching the positioning and holding assembly can include coupling a positioning portion to a predetermined location on the shaft of the delivery device and coupling a holding portion to the positioning device.

[0050] In some embodiments, the act of actuating the retraction device can release the prosthetic heart valve from the positioning and holding assembly.

[0051] In some embodiments, compression of the prosthetic heart valve can cause the prosthetic heart valve to elongate in one direction such that a proximal end portion of the prosthetic heart valve is fixedly aligned with the proximal end of the valve mounting portion and a distal end portion of the prosthetic heart valve extends distally during compression until aligned with the distal end of the valve mounting portion when the prosthetic heart valve is in the compressed configuration.

[0052] In some embodiments, the method may further include the step of decoupling the positioning and holding assembly from the delivery device after the prosthetic heart valve is crimped at the valve mounting portion.

[0053] In some embodiments, the method may further include removing the delivery device together with the prosthetic heart valve from the retraction device after the positioning and holding assembly has been decoupled from the delivery device.

[0054] In some embodiments, the positioning and holding assembly may include one or more retention members configured to releasably couple to the prosthetic heart valve. The positioning and holding assembly may further include one or more arms, each of which may extend distally into the interior space of the prosthetic heart valve when the retention member is coupled to the prosthetic heart valve.

[0055] In some embodiments, the act of actuating the retraction device can push the one or more retention members radially inward to decouple the one or more retention members from the prosthetic heart valve.

[0056] In some embodiments, the act of actuating the retraction device can push one or more arms proximally and away from the prosthetic heart valve.

[0057] Certain embodiments of the present disclosure also relate to a retention device for a prosthetic heart valve. The retention device may include one or more retention members configured to secure the prosthetic heart valve to the retention device when the prosthetic heart valve is in a radially expanded configuration and configured to release the prosthetic heart valve from the retention device when the prosthetic heart valve is compressed from the radially expanded configuration to a radially compressed configuration with a retraction device.

[0058] In some embodiments, each of the retention members can have a protrusion extending radially outward at a distal end of the retention member, and each protrusion can be configured to extend radially outward into an opening in the prosthetic heart valve when the prosthetic heart valve is in the expanded configuration.

[0059] In some embodiments, a distal portion of each retention member can extend distally into the prosthetic heart valve when the prosthetic heart valve is in the expanded configuration, and a distal portion of each retention member can be disposed proximal to the prosthetic heart valve when the prosthetic heart valve is in the compressed configuration.

[0060] In some embodiments, the retention device may further comprise a valve alignment portion configured to secure the retention device to the retraction device. The retaining member may be movable relative to a distal surface of the valve alignment portion.

[0061] In some embodiments, a proximal end portion of the prosthetic heart valve can abut a distal surface of the valve alignment portion when the prosthetic heart valve is in the expanded configuration.

[0062] In some embodiments, the retention device may further comprise one or more biasing members configured to bias the retention member proximally against the valve alignment portion.

[0063] In some embodiments, the retention device may further comprise one or more arms, the distal end of each of which may extend distally relative to the distal face of the valve alignment portion when the retention member is coupled to the prosthetic heart valve.

[0064] In some embodiments, at least one arm can be circumferentially disposed between a pair of adjacent retention members. The retention members can extend radially outward relative to the arms when the prosthetic heart valve is in the expanded configuration. The retention members can be compressed radially inward and radially aligned with at least a portion of the arms when the prosthetic heart valve is radially compressed with the retraction device.

[0065] In some embodiments, the distal end of each arm may include an inclined surface configured to interface with the retraction device such that, upon actuation of the retraction device, the retraction device can exert a force on the inclined surface, urging the corresponding arm proximally relative to the valve alignment portion.

[0066] Additionally, certain embodiments of the present disclosure relate to a positioning device for positioning a prosthetic heart valve in a delivery device. The positioning device may include a body and one or more coupling members mateable with one or more complementary coupling members of a prosthetic heart valve retention device. The body may include an inner surface defining an axially extending passage sized to form an interference fit with the shaft of the delivery device.

[0067] In some embodiments, the inner surface of the body may include an array of circumferentially oriented grooves extending from the proximal end of the body to the distal end of the body such that sterilizing gas can permeate through the grooves and into the passageway when the body is coupled to the shaft.

[0068] The various innovations of the present disclosure can be used in combination or separately. This summary is provided to introduce a selection of concepts in a simplified form that are further described below in the detailed description. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter. The foregoing and other objects, features, and advantages of the present disclosure will become more apparent from the following detailed description, which proceeds with reference to the accompanying drawings. [Brief explanation of the drawings]

[0069] [Figure 1] 1 is a perspective view of an exemplary prosthetic heart valve. [Figure 2] FIG. 12 is a perspective view of a positioning and holding device assembly attached to a delivery device, according to one embodiment. [Figure 3A] FIG. 1 is a side elevational view of a delivery device according to one embodiment. [Figure 3B] FIG. 3B is an enlarged view of a distal end portion of the delivery device of FIG. 3A. [Figure 4A] 1 is a perspective view of a retraction device according to one embodiment; FIG. [Figure 4B] 4B is a view of the distal end portion of the delivery device and prosthetic valve inserted into the crimping opening of the crimping device of FIG. 4A. [Figure 5A] FIG. 12 is a perspective view of a positioning device in place on a delivery device and a retention device with a prosthetic valve positioned on the delivery device. [Figure 5B] 5B is a perspective view similar to FIG. 5A after the holding device has been coupled to the positioning device. [Figure 5C] FIG. 10 is a perspective view showing a retaining device coupled to the front face of the retracting device. [Figure 5D]FIG. 10 is a perspective view showing the removal of the delivery device, together with the prosthetic heart valve crimped thereon, from the retention and crimping devices. [Figure 6] FIG. 10 is a perspective view showing the positioning device being removed from the delivery device. [Figure 7A] FIG. 1 is a perspective view of a retention device according to one embodiment. [Figure 7B] 7B is an exploded view of the retention device of FIG. 7A from a distal perspective. FIG. [Figure 7C] 7B is an exploded side perspective view of the retainer of FIG. 7A. FIG. [Figure 8] FIG. 1 is a proximal perspective view of a retention device and a coupled prosthetic heart valve in an expanded configuration. [Figure 9A] FIG. 1 is a distal end view of a retention device and a coupled prosthetic heart valve in an expanded configuration. [Figure 9B] FIG. 1 is a distal end view of a retention device and a prosthetic heart valve in a compressed configuration. [Figure 10] FIG. 10 is an enlarged view of a portion of the bond interface between a prosthetic heart valve and a retention device, according to one embodiment. [Figure 11A] 10 is a diagram of a prosthetic heart valve coupled to a retention device, according to another embodiment. [Figure 11B] FIG. 11B is a diagram of a biasing mechanism in the retainer of FIG. 11A. [Figure 12A] 1 is a cross-sectional view of a crimping device with a prosthetic valve and a distal end portion of a delivery device inside the crimping device. [Figure 12B] 1 is a cross-sectional view of a crimping device with a prosthetic valve and a distal end portion of a delivery device inside the crimping device. [Figure 13] FIG. 10 is a perspective view of a container containing an assembly of a retention device and a prosthetic heart valve according to another embodiment. [Figure 14] FIG. 1 is a diagram of a packaging assembly containing multiple devices that can be used to implant a prosthetic heart valve. [Figure 15A] 10 is a perspective view of another embodiment of a retention device and a frame of a prosthetic heart valve coupled to the retention device via a plurality of valve retaining members. [Figure 15B]15B is a cross-sectional view of the frame and retainer depicted in FIG. 15A, with multiple valve retaining members shown in a valve-engaging position. [Figure 15C] 15B is a cross-sectional view of the retention device depicted in FIG. 15A, without showing the frame, with multiple valve retaining members shown in the valve release position. [Figure 15D] 15B is a cross-sectional view of the retention device depicted in FIG. 15A, without the frame, with multiple valve retaining members shown in a stowed position. [Figure 16A] 10 is a side perspective view of a valve retainer according to another embodiment; FIG. [Figure 16B] 16B is a front perspective view of an alternative embodiment of a retention device comprising multiple valve retaining members as depicted in FIG. 16A. [Figure 16C] FIG. 16C is a front perspective view of a frame of a prosthetic heart valve coupled to the retention device depicted in FIG. 16B, according to one embodiment. [Figure 16D] FIG. 16C is a rear perspective view of the retainer and frame as depicted in FIG. 16B, with the frame decoupled from the retainer. DETAILED DESCRIPTION OF THE INVENTION

[0070] For purposes of this description, certain aspects, advantages, and novel features of the disclosed embodiments are described herein. The disclosed methods, apparatus, and systems should not be construed as limiting in any way. Instead, the present disclosure is directed to all novel and non-obvious features and aspects of the various disclosed embodiments, both alone and in various combinations and subcombinations with one another. The methods, apparatus, and systems are not limited to those particular aspects, features, or combinations, and the disclosed embodiments do not require that any one or more particular advantages exist or problems be solved.

[0071] It should be noted at the outset that while a prosthetic heart valve is used as an exemplary collapsible prosthetic device, the disclosed techniques can be used with various other types of collapsible prosthetic devices, such as stents and / or valve repair devices.

[0072] For various reasons, prosthetic heart valves may be stored and shipped in their expanded state. In the case of prosthetic heart valves for transvascular implantation procedures, the prosthetic heart valve may be crimped in a designated placement area (also referred to as the "crimping area" or "valve mounting portion") of the delivery device. In many instances, high accuracy and precision are required during crimping.

[0073] Accurate and precise alignment of the crimped prosthetic heart valve with the designated placement area can be difficult because, for example, the prosthetic heart valve may elongate longitudinally during the crimping procedure. Furthermore, the crimped area may be obscured from the user's perspective by the crimping jaws of the crimping device, making it difficult to see the location of the prosthetic heart valve during the crimping procedure.

[0074] Although the prosthetic heart valve may sometimes be crimped in a less-than-optimal position, adjustments can be made by sliding the prosthetic heart valve into position after it has been crimped. Such adjustments are not recommended due to potential damage to the prosthetic heart valve leaflets. This may even require discarding the entire delivery system and prosthetic heart valve, both of which are expensive and wasteful.

[0075] Also, special care must be taken to ensure that the prosthetic heart valve is correctly oriented in the delivery device, e.g., for a transfemoral delivery method, the prosthetic valve is loaded onto the delivery device in a first orientation (the prosthetic valve inlet is loaded distal to the outlet for implantation at the aortic level), and for a transventricular method, the prosthetic heart valve is loaded onto the delivery device in a second orientation (the prosthetic valve outlet is loaded distal to the inlet for implantation at the aortic level).

[0076] As a result, the retraction procedure must usually be performed by a highly skilled clinical specialist and is time consuming. Therefore, there is a need for improved devices and methods for retracting prosthetic heart valves more quickly, easily, and accurately.

[0077] Disclosed herein are various devices and methods that can, for example, more accurately, more quickly, and / or more reproducibly recoil prosthetic heart valves. The disclosed devices and methods can, among other things, reduce the level of skill and / or training required of the person performing the recoil procedure. Furthermore, this can reduce the costs associated with such procedures.

[0078] Prosthetic heart valves 1 illustrates an exemplary prosthetic heart valve 10. The valve 10 may have several main components: a stent or frame 12, a valve structure 14, and a skirt assembly 16.

[0079] The frame 12 may have an annular shape and defines an inlet end 24 and an outlet end 26 of the prosthetic heart valve. The valvular structure 14 may be configured to allow blood to flow through the prosthetic heart valve 10 in a direction from the inlet end 24 to the outlet end 26 of the prosthetic heart valve, and to prevent blood from flowing through the prosthetic heart valve in a direction from the outlet end 26 to the inlet end 24. The frame 12 may include a plurality of struts 28 that collectively define a plurality of open cells 30 of the frame 12. The valvular structure 14 may include one or more leaflets 18 (three in the illustrated embodiment), which may be made from native tissue (e.g., pericardial tissue) and / or any of a variety of synthetic materials.

[0080] Frame 12 can be made from any of a variety of suitable plastically expandable materials known in the art (e.g., stainless steel, cobalt-chromium alloy, etc.) or self-expanding materials (e.g., nitinol). If constructed from a plastically expandable material, frame 12 (and thus valve 10) can be crimped to a radially compressed configuration in a delivery device and then expanded inside the patient by an inflatable balloon or other suitable expansion mechanism. If constructed from a self-expanding material, frame 12 (and thus valve 10) can be crimped to a radially compressed configuration and restrained in the compressed configuration by insertion into a sheath or equivalent mechanism of a delivery device. Once inside the body, the valve can be advanced from the delivery sheath, allowing the valve to expand to its functional size.

[0081] The prosthetic heart valve 10 can be adapted to be implanted in the native aortic annulus and / or the native annulus of the heart. Additional details regarding prosthetic heart valves can be found in U.S. Patent No. 9,393,110, U.S. Patent No. 8,449,599, U.S. Patent No. 7,999,394, U.S. Patent No. 7,510,575, U.S. Patent Application Publication No. 2016 / 0317301, and U.S. Patent Application No. 15 / 664,430 (filed July 31, 2017), all of which are incorporated by reference herein.

[0082] Mounting Assembly 2, the prosthetic heart valve 10 can be easily and accurately mounted to the delivery device 50 using an exemplary mounting assembly 100. The mounting assembly 100 can include a positioning device 180 (also referred to as an alignment clip) that can be releasably mounted or coupled to the delivery device 50. The mounting assembly 100 can further include a retention device 110 that can be releasably coupled to the positioning device 180. The prosthetic heart valve 10 can also be releasably coupled to the retention device 110, which, when coupled to the positioning device 180, holds the prosthetic heart valve in a predetermined position and orientation relative to the delivery device 50 for retracting the prosthetic valve in the delivery device 50, as described further below.

[0083] As described more fully below, the mounting assembly 100 may further include a retraction device, such as retraction device 160 (FIG. 4A). The retention device 110 may be releasably coupled to the retraction device 160, and actuation of the retraction device may retract the prosthetic heart valve 10 in the delivery device 50.

[0084] 2 and 5A, the outflow end 26 of the prosthetic heart valve 10 may be coupled to or supported by the retention device 110. In other embodiments, the inflow end 24 of the prosthetic heart valve 10 may be coupled to or supported by the retention device 110. It should be understood that the orientation of the prosthetic heart valve 10 depends on the delivery technique used to implant the prosthetic heart valve. FIG. 2 shows the retention device 110 holding the outflow end 26 of the prosthetic valve positioned proximal to the inflow end 24 for delivering the prosthetic valve to the native aortic valve via a transfemoral delivery technique. Alternatively, the retention device 110 can hold the inflow end 24 of the prosthetic valve proximal to the outflow end 26 for delivering the prosthetic valve to the native aortic valve via a transventricular delivery technique.

[0085] Coupling of the prosthetic heart valve 10 to the retention device 110 can occur, for example, as part of a manufacturing and / or packaging process. Also as part of the manufacturing and / or packaging process, a pre-coupled / pre-assembled prosthetic heart valve 10 and retention device 110 can be packaged with a delivery device that corresponds to the orientation in which the prosthetic heart valve 10 is coupled to the retention device 110 (e.g., if the prosthetic heart valve is coupled to the retention device in the transfemoral orientation shown in FIG. 2, the transfemoral delivery device can be packaged with the prosthetic heart valve 10 in the transfemoral orientation shown in FIG. 2). (Packaged with the heart valve.) Matching the orientation of the prosthetic heart valve with the orientation of the delivery device can therefore reduce or eliminate potential procedural errors, such as loading the prosthetic heart valve 10 backwards and therefore in an incorrect orientation relative to the delivery device (e.g., loading a transfemorally oriented prosthetic heart valve into a transventricular delivery device, or vice versa).

[0086] In a specific embodiment, the positioning device 180 may be pre-loaded onto the delivery device at a predetermined location so that when the retention device 110 is coupled to the positioning device 180 by the end user (with the prosthetic heart valve 10 pre-loaded to the retention device 110), the prosthetic heart valve 10 will be precisely positioned relative to the valve-mounting portion of the delivery device for subsequent retraction. Thus, in this approach, the assembly consisting of the retention device 110 and prosthetic heart valve 10 can be stored separately from the delivery device (such as when the prosthetic heart valve is stored in a preservative solution), but the end user can easily connect the retention device 110 to the positioning device 180 in the operating room, which will automatically position the prosthetic heart valve in a desired location relative to the delivery device for subsequent retraction immediately prior to implantation, thereby shortening procedure time and reducing the chance of procedural errors.

[0087] In a specific embodiment, the pre-bonded / pre-assembled prosthetic heart valve 10 and retention device 110 can be pre-bonded to the positioning device 180, which is then pre-loaded into a delivery device in its final orientation and packaged together in a sterile package for shipment to the end user. In this manner, the end user (e.g., a physician) does not need to bond the retention device 110 to the positioning device 180 or load the positioning device 180 onto the delivery device, thereby further reducing procedure time. Such an embodiment can be advantageous when the prosthetic heart valve does not need to be stored in a preservation solution separate from the delivery device. For example, prosthetic heart valves with so-called dry tissue leaflets are processed during the manufacturing process so that the prosthetic heart valve can be stored dry (not immersed in a preservation solution).

[0088] In some embodiments, the retaining device 110 and the positioning device 180 are not separable components, but instead comprise a single retaining and positioning device that is attached to the delivery device and configured to releasably retain the prosthetic heart valve 10. Such an embodiment can be used, for example, when the prosthetic heart valve can be stored dry. The retaining and positioning device can be pre-attached to the delivery device, the prosthetic heart valve can be pre-coupled to the retaining and positioning device, and all three components can be contained in the same sterile packaging for shipping and storage. The retaining and positioning device can comprise a retaining portion configured to hold the prosthetic valve and a positioning portion configured to be attached to the delivery device.

[0089] As used herein, the terms "pre-bonded," "pre-assembled," or "pre-attached" mean that two components are bonded or assembled together, or one component is attached to another, by the manufacturer before packaging and shipping from the manufacturer to a distributor or end user (e.g., a hospital).

[0090] To further assist in accurately pairing the prosthetic heart valve with the delivery device, one or more of the components may be color-coded with colored indicia or other types of visual indicia representative of the delivery technique used to implant the prosthetic valve. For example, when the prosthetic heart valve is coupled to the retention device 110 for transfemoral delivery, the retention device 110 can be a first color (e.g., red), and the delivery device and / or positioning device configured for transfemoral delivery can also be the same first color. As another example, when the prosthetic heart valve is coupled to the retention device 110 for transventricular delivery, the retention device 110 can be a second color (e.g., green), and the delivery device and / or positioning device for transventricular delivery can also be the same second color. In this manner, the color coding can aid the assembler and / or user in their selection and / or ensure that the prosthetic heart valve and delivery device are accurately paired.

[0091] delivery device 3A and 3B show a delivery device 50 according to one embodiment. The delivery device 50 may include a handle 52 and an outer shaft 58 extending distally from the handle 52. The delivery device 50 may also include an inner shaft 60 extending distally from the handle 52 and coaxially through the outer shaft 58. The inner shaft 60 may also be referred to as a transfer catheter, as a prosthetic heart valve may be attached to the inner shaft for delivery into a patient's body. In some embodiments, the inner shaft 60 may be movable relative to the outer shaft 58 (i.e., the inner shaft may be rotated and / or axially moved relative to the outer shaft, or the outer shaft may be moved relative to the inner shaft).

[0092] The delivery device 50 may further include a nosecone 64 coupled to the distal end portion of the inner shaft 60. The inner shaft 60 may include a valve mounting portion (or designated placement area) 62 positioned proximally and adjacent to the nosecone 64. The valve mounting portion 62 may have a proximal end 68 and a distal end 66. The axial length L of the valve mounting portion 62, measured between the proximal end 68 and the distal end 66, may be approximately equal to the axial length of the prosthetic heart valve 10 when fully retracted in the transfer catheter 60. The delivery device 50 may also include a proximal stop 74 and a distal stop 76, respectively, attached to the inner shaft 60, with the space between the proximal and distal stops defining the valve mounting portion. The proximal stop 74 may be attached to the distal end portion 59 of the outer shaft and / or to the exterior surface of the inner shaft 60. The distal stop 76 may be formed as a proximal end portion of the nosecone 64 , but in other embodiments may be formed separately and secured to the exterior surface of the nosecone and / or inner shaft 60 .

[0093] Although not shown, a guidewire can extend through the central lumen of the inner shaft 60 and the inner lumen of the nosecone 64, thereby allowing the delivery device 50 to be advanced over a guidewire inserted into the patient's vascular system.

[0094] The handle 52 may be configured to position and / or manipulate the outer shaft 58. For example, the handle 52 may include an actuation mechanism (e.g., a rotatable knob) configured to rotate the outer shaft 58 about the inner shaft 60 and / or to slide the outer shaft 58 relative to the inner shaft 60 along its longitudinal axis.

[0095] The distal portion of the delivery device 50 may include a steerable portion 56 that has sufficient flexibility to traverse tortuous anatomy without sacrificing the stiffness of the outer shaft 58. The delivery device 50 may also include one or more pull wires (not shown) configured to curve the steerable portion 56 in a given direction or to straighten the steerable portion 56.

[0096] For example, a pull wire can extend through a lumen in the outer shaft 58. The distal end of the pull wire can be securely fixed to the distal end portion 59 of the outer shaft 58. The proximal end of the pull wire can be operably coupled to a steering mechanism (e.g., the illustrated rotatable knob 78, button, etc.) located on the handle 52. Actuating the steering mechanism can increase or decrease tension in the pull wire, thereby causing the steerable portion 56 to bend or straighten.

[0097] In some embodiments, the distal end 80 of the outer shaft 58 may be positioned proximally and immediately adjacent the proximal stop 74 to minimize the overall length of the relatively stiff, distal straight section of the delivery device (including the valve mounting portion 62, the proximal stop 74, the distal stop 76, and the nosecone 64), thereby improving the tracking capabilities of the delivery device 50. In some embodiments, the distal end of the pull wire may be secured to the outer shaft 58 at or slightly proximal to the outer shaft's distal end 80 to minimize the overall length of the steerable portion 56.

[0098] 3A and 3B has an inflatable balloon 54 mounted on the inner shaft 60 over the valve mounting portion 62. A proximal end portion 54p of the balloon 54 may extend over a proximal stop 74 and may be secured to the outer surface of the distal end portion 59 of the outer shaft 58. A distal end portion 54d of the balloon 54 may extend over a distal stop 76 and may be secured to the outer surface of the nosecone 64.

[0099] As depicted, the balloon 54 can have a proximal shoulder 67, a distal shoulder 65, and an intermediate portion 69 disposed between the shoulders 65, 67. The proximal shoulder 67 can be approximately aligned with the proximal end 68 of the valve mounting portion 62, and the distal shoulder 65 can be approximately aligned with the distal end 66 of the valve mounting portion 62. Both the proximal shoulder 67 and the distal shoulder 65 of the balloon 54 can flare radially outward from the respective ends of the intermediate portion 69 to proximal and distal stops 74, 76, thereby defining a generally dogbone-shaped balloon 54. In this manner, the proximal and distal shoulders define sloped surfaces of the balloon.

[0100] The balloon 54 may be fluidly coupled to an inflation fluid conduit (not shown) on the outer shaft 58 that extends to a port 53 positioned on the handle 52 such that the balloon 54 may be inflated from a collapsed configuration to an expanded configuration when inflation fluid (e.g., saline) is supplied to the balloon 54 via the port 53 and the inflation fluid conduit.

[0101] In some embodiments, the prosthetic heart valve 10 may be crimped on the balloon 54 located on the valve mounting portion 62. Thus, at the implantation site, the balloon 54 may be inflated to expand the prosthetic heart valve 10 to its fully functional size. The beveled shoulders 67 and 65 may, for example, facilitate smooth expansion of the prosthetic heart valve 10 and maintain the positioning of the prosthetic heart valve relative to the balloon 54 during expansion. The beveled shoulders may also facilitate easier retrieval of the balloon 54 after implantation.

[0102] In another embodiment (not shown), a self-expanding prosthetic heart valve can be crimped and inserted into a sheath of a delivery device. After placement in the body, the sheath is retracted, allowing the prosthetic heart valve to expand inside the body.

[0103] Additional details regarding delivery devices can be found, for example, in U.S. Patent No. 9,339,384 and U.S. Patent Application Publication No. 2017 / 0065415, both of which are incorporated by reference herein.

[0104] Shrinking device 4A shows a retraction device 160, according to an exemplary embodiment. Retraction device 160 may have a window or opening 172 exposing a plurality of jaws 170 arranged about a central axis 171 of jaws 170. Jaws 170 may define variably sized retraction openings 174 between their inner ends. Jaws 170 may be positioned within a rotating portion comprising a housing 176 and operably coupled to an actuator in the form of a lever or handle 177 coupled to and extending from housing 176.

[0105] The retraction device 160 may further include a frame 178 that can act as a stand or base. The retraction device 160 may include a coupling mechanism configured to releasably couple to the retention device 110. For example, in the embodiment depicted in FIG. 4A , the proximal or front surface 166 of the frame 178 may have one or more catches 168 (e.g., three in the illustrated embodiment) configured to matingly engage with one or more corresponding tabs on the retention device 110, as described more fully below. As shown, the catches 168 may project radially outward relative to the window 172. The catches 168 may be distributed circumferentially around the window 172.

[0106] 4A shows the retraction opening 174 in the "open" position, with the jaws 170 moved to a radially outward position so that the opening 174 has a relatively large diameter. In the "open" position, an expanded annular implant (e.g., prosthetic heart valve 10) can be inserted into the retraction opening 174.

[0107] 4B shows the prosthetic heart valve 10 and the valve mounting portion 62 of the delivery device 50 inserted into the retraction opening 174. Actuation of the retraction device 160, such as by pressing downward on the lever 177, moves the retraction opening 174 from an "open" position to a "closed" or contracted position. When moved to the closed position by the lever 177, the jaws 170 move radially inward toward each other to reduce the size of the retraction opening 174 and compress the prosthetic heart valve in the valve mounting portion 62 of the delivery device 50.

[0108] Exemplary embodiments of retraction apparatus and related retraction methods are further described in U.S. Patent Application Publication No. 2015 / 0336150, U.S. Patent Application Publication No. 2015 / 0190225, U.S. Patent Application Publication No. 2013 / 0030418, and U.S. Patent No. 7,999,394, the disclosures of which are incorporated herein by reference.

[0109] Installation process 5A-5D illustrate a method of collapsing the prosthetic heart valve 10 in a delivery device 50, according to one exemplary embodiment. The prosthetic heart valve 10 is shown in an expanded configuration in Figures 5A-5B and in a compressed configuration in Figure 5D. Generally, the prosthetic heart valve 10 in the compressed configuration has a longer axial dimension and a smaller radial cross-sectional dimension than in the expanded configuration.

[0110] As shown in FIG. 5A , the prosthetic heart valve 10 can be coupled to the retention device 110 to form a valve-retention device assembly. The positioning device 180 can be coupled to the outer shaft 58 of the delivery device 50 at a predetermined location. For example, the proximal end of the positioning device 180 can be aligned with a mark 70 ( FIG. 5B ) on the outer shaft 58 and secured to the outer shaft 58 against inadvertent movement (rotational and axial) relative to the outer shaft. The mark 70 can be spaced relative to the valve-mounting portion 62 of the transfer catheter 60. The axial distance D between the mark 70 and the proximal end 68 of the valve-mounting portion 62 can be predetermined to align the prosthetic heart valve with the valve-mounting portion 62, as described in further detail below.

[0111] 5B , the valve and retention device assembly may be positioned on the delivery device 50 and coupled to a positioning device 180. The positioning of the positioning device 180 relative to the delivery catheter 50 may be configured to align the prosthetic heart valve 10 with respect to the delivery device 50. For example, a proximal end portion of the retention device 110 may be releasably coupled to a distal end of the positioning device 180. Because the location of the positioning device 180 on the delivery device 50 is predetermined, the location of the prosthetic heart valve 10 (coupled to the retention device 110) on the delivery device 50 may also be predetermined. Specifically, when the retention device 110 is coupled to the positioning device 180, the proximal end of the prosthetic heart valve 10 may be aligned with the proximal end 68 of the valve mounting portion 62.

[0112] With the positioning device, retention device, and prosthetic valve attached to the delivery device as shown in Figure 5B, the prosthetic heart valve 10 and delivery device 50 can be inserted into the retraction device 160 as shown in Figure 5C. The retention device 110 (together with the positioning device 180) can be coupled to the retraction device 160 to align the prosthetic heart valve 10 with the retraction jaws 170 of the retraction device 160.

[0113] When coupled to the retraction device in this manner, engagement of the retention device 110 with the catch 168 on the retraction device is effective to position the prosthetic valve 10 at a desired location within the retraction opening 174 and to retain the prosthetic heart valve and delivery device against movement relative to the retraction device. As previously described, the positioning device 180 retains the retention device 110 and prosthetic valve 10 in a fixed location relative to the delivery device. Thus, when the retention device is coupled to the retraction device as shown in FIG. 5C When the prosthetic valve 10 is in place, it is held in the desired location along the delivery device within the crimping device for later crimping of the prosthetic valve at the valve mounting portion 62. Advantageously, the user does not have to manually position the prosthetic valve relative to the crimping jaws and valve mounting portion 62 and maintain their position while operating the crimping device.

[0114] As such, the retraction device 160 can be used to retract the prosthetic heart valve 10 in the delivery device 50, as shown in FIG. 5D . As will be described more fully below, actuating the retraction device 160 can release the prosthetic heart valve 10 from the retention device 110. Actuating the retraction device 160 can also radially compress the prosthetic heart valve 10 from an expanded configuration to a compressed configuration. The retracted prosthetic heart valve 10 has a reduced radial cross-sectional dimension and is decoupled from the retention device 110, so that the delivery device 50, along with the retracted prosthetic heart valve 10, can be removed from the mounting assembly 100.

[0115] These components and various methods for using the components are further described below.

[0116] Positioning device FIG. 6 illustrates one exemplary embodiment of a positioning device 180. As shown, the positioning device 180 in the illustrated embodiment may include a body 181 having a clamshell configuration with a first portion 182 and a second portion 184 hingedly connected to one another by a hinge member 186. The first portion 182 and the second portion 184 may be pivotable relative to one another between an open position (shown in FIG. 6) and a closed position (shown in FIG. 5C). The positioning device 180 may also include a clasp or latching mechanism, generally indicated at 183, configured to retain the body 181 in the closed position while attached to the delivery device 50.

[0117] Body 181 can have an inner surface 185 that defines a central passageway or lumen 188 that receives the outer shaft of delivery device 50. Central passageway 188 can be sized to form an interference or friction fit with portion 72 of outer shaft 58 distally and adjacent to indicium 70. In a specific embodiment, when body 181 is in a closed position around portion 72, the interference fit with portion 72 is sufficient to hold the positioning device immobile against rotational and axial movement relative to the shaft during normal use and handling.

[0118] It should be noted that the indicia 70 can be an annular shoulder or ridge, or can be a line or other type of visual indicia formed or printed on the shaft 58. In the illustrated embodiment, the portion 72 can have a smaller outer diameter compared to the portion of the shaft 58 proximal to the portion 72 so as to define an annular shoulder 70 that can abut an adjacent surface of the positioning device 180 and prevent axial movement of the positioning device in the proximal direction along the outer shaft 58.

[0119] In the closed configuration (e.g., Figures 2 and 5A-5C), the first portion 182 and the second portion 184 are held in a closed position by the fastening mechanism 183 such that the portion 72 of the outer shaft 58 is completely surrounded by the body 181.

[0120] In the depicted embodiment, fastening mechanism 183 comprises an outwardly extending protrusion 183b (FIG. 5D) positioned on an inner surface of first portion 182 opposite hinge member 186 and an inwardly extending protrusion 183a (FIG. 5D) positioned on an inner surface of second portion 184 opposite hinge member 186. Protrusions 183a, 183b may be complementary shaped and sized to form a snap-fit ​​connection with one another. Thus, first portion 182 and second portion 184 can be placed in a closed configuration by forcing protrusion 183a against protrusion 183b until protrusion 183a slides over and engages the adjacent surface of protrusion 183b, as shown in FIG. 5C. When closing the positioning device, second portion 184 can flex or deform slightly to allow protrusion 183a to pass over protrusion 183b, thereby returning to its original shape to hold second portion 184 in the closed position relative to first portion 182. To open positioning device 180, second portion 184 is pried away from first portion 182, allowing protrusion 183a to pass back over protrusion 183b as second portion 184 is pivoted toward the open position. In alternative embodiments, various other types of fastening mechanisms may be used to hold first portion 182 and second portion 184 in the closed position, such as clips, hooks, locks, keys, claps, snaps, buttons, buckles, zippers, hook-and-loop fasteners, magnets, etc.

[0121] 5D , the inner surface 185 of the body 181 may include one or more channels 191 extending from the proximal end 190 of the body 181 to the distal end 192 of the body 181. Each channel 191 may have a plurality of axially spaced, circumferentially oriented grooves 194 formed in the inner surface 185. While two channels 191 are shown in FIGS. 5D and 6 (one on the inner surface of the first portion 182 and one on the inner surface of the second portion 184), it should be understood that the body 181 may have any number of channels 191 circumferentially arranged on the inner surface 185. When the positioning device is closed, the grooves in first portion 182 can be aligned with respective grooves in second portion 184 such that each groove in first portion 182 is paired with a respective groove in second portion 184 to define a complete groove extending 360 degrees along inner surface 185 of body 181.

[0122] Because the channel 191 creates a void in the inner surface 185 and extends through the body 181, a sterilizing gas can permeate or flow through the channel 191 into the central passage 188, even when the body 181 is coupled to the outer shaft 58 in a closed position. Thus, when the positioning device 180 is coupled to the delivery device 50, both the inner surface 185 of the positioning device 180, which extends through the central passage 188, and the outer surface of the outer shaft 58 can be sterilized with a sterilizing gas. For example, after the prosthetic valve and components of the mounting assembly are removed from the packaging by the end user and assembled in the delivery device as shown in FIG. 5B (if any components are not already pre-assembled or pre-mounted), the components can be exposed to an ethylene oxide sterilization process (or other sterilizing gas) if resterilization of any of the prosthetic valve, delivery device 50, and mounting assembly is deemed necessary prior to implantation.

[0123] In an alternative embodiment, one or more of the grooves 194 may be replaced by one or more slots extending through the body 181 from the outer surface to the inner surface 185. In the closed configuration, the slots allow sterilizing gas to permeate or flow into the central passageway 188 for sterilization.

[0124] The positioning device 180 may also have a flange 196 coupled to the first portion 182 adjacent the distal end 192 of the body 181. The flange 196 may have a larger radial diameter than the body 181. In certain embodiments, one or more tabs 198 may project radially outward from the outer edge of the flange 196. The flange 196 and / or tabs 198 may be used, for example, to couple the positioning device 180 to the retaining device 110, as described in further detail below.

[0125] Coupling mechanism 5A-5D further illustrate how the retaining device 110 is coupled to the positioning device 180 and how the retaining device 110 is coupled to the retracting device 160. FIG.

[0126] 5A, the proximal end of the retaining device 110 may have a flange 116, which may be configured to be releasably coupled to a flange 196 of the positioning device 180. The flange 116 of the retaining device 110 may be configured to be releasably coupled to the retracting device 160.

[0127] In certain embodiments, the flange 116 of the retainer 110 extends axially from the proximal face of the flange 116. The retaining device 110 may have one or more outwardly protruding catches 118. The catches 118 of the retaining device may have internal recesses that are complementary to one or more tabs 198 located on the flange 196 of the positioning device 180. In other words, the catches 118 of the retaining device 110 may be sized, shaped, and positioned such that they can matingly engage with corresponding tabs 198 of the positioning device 180.

[0128] 5C , each catch 118 may extend in a circumferential arc and may have an open end 114 and a closed end 115 opposite the open end 114. The catches 118 may be arranged consecutively such that the open ends 114 and closed ends 115 of the catches 118 are circumferentially juxtaposed. Thus, coupling and decoupling between the retaining device 110 and the positioning device 180 may be achieved by placing the flange 116 of the retaining device 110 against the flange 196 of the positioning device 180 with the tabs 198 of the positioning device adjacent the open ends 114 of the catches 118 of the retaining device, and then coaxially rotating the retaining device 110 relative to the positioning device 180 to position the tabs 198 in the respective catches 118.

[0129] For example, retaining device 110 may be coupled to positioning device 180 by rotating retaining device 110 in one direction (e.g., clockwise) such that tab 198 may be inserted through open end 114 into the internal recess of catch 118, while the insertion may be limited by closed end 115 of catch 118. Conversely, decoupling between retaining device 110 and positioning device 180 may be achieved by rotating retaining device 110 in the opposite direction (e.g., counterclockwise) such that tab 198 may exit through open end 114.

[0130] In specific embodiments, catch 118 may be sized and shaped to form an interference or friction fit with tab 198 that is sufficient to hold the positioning device and retaining device together and prevent relative movement between the two components during normal use and handling. In some embodiments, catch 118 and / or tab 198 may include additional features, such as a protrusion formed on one component and a corresponding detent formed on the other component that receives the protrusion, to help hold the positioning device and retaining device together.

[0131] In certain embodiments, the flange 116 of the retention device 110 may further include one or more tabs 119 projecting radially outward from the outer edge of the flange 116. As previously described, the front surface 166 of the retraction device 160 may have one or more catches 168 projecting axially outward from the proximal surface of the retraction device 160. The retraction device catches 168 may have internal recesses that are complementary to one or more tabs 119 positioned on the flange 116 of the retention device 110. In other words, the catches 168 of the retraction device 160 may be sized, shaped, and positioned such that they can matingly engage with corresponding tabs 119 of the retention device 110.

[0132] In some embodiments, each tab 119 can be a generally flat protrusion or extension of flange 116 (e.g., FIGS. 5A-5D). In other embodiments, each tab 119 can comprise a cantilevered arm extending outward from flange 116 (e.g., FIGS. 7A-7C). Tab 119 and / or catch 168 can also comprise additional features to help retain retention device 110 and retraction device 160 together. For example, as shown in FIGS. 7A-7C, each tab 119 can comprise a small nub or protrusion 117 protruding outward from the cantilevered arm. Nub 117 can be configured to engage a complementarily positioned detent (not shown) formed on a corresponding catch 168 of the retraction device to help retain retention device 110 on the retraction device 160.

[0133] 5C and 5D, each catch 168 may extend in a circumferential arc and may have an open end 164 and a closed end 165 opposite the open end 164. may be arranged sequentially such that the open and closed ends 164, 165 of the catches 168 are circumferentially juxtaposed. Thus, coupling and decoupling between the retraction device 160 and the retention device 110 may be achieved by placing the flange 166 of the retention device 110 against the front surface 166 of the retraction device 160 with the tabs 119 adjacent the open ends 164 of the catches, and then coaxially rotating the retention device 110 relative to the retraction device 160.

[0134] For example, coupling between retainer 110 and retraction device 160 may be achieved by rotating retainer 110 in one direction (e.g., clockwise) such that tab 119 may be inserted through open end 164 into the internal recess of catch 168, while the insertion may be restricted by closed end 165 of catch 168. Conversely, decoupling between retainer 110 and retraction device 160 may be achieved by rotating retainer 110 in the opposite direction (e.g., counterclockwise) such that tab 119 may exit through open end 164.

[0135] In particular embodiments, catch 168 may be sized and shaped to form an interference or friction fit with tab 119 that is sufficient to retain retainer 110 in retraction device 160 and prevent relative movement between the two components during normal use and handling. In some embodiments, catch 168 and / or tab 119 may include additional features, such as a protrusion (e.g., protrusion 117) formed on one component and a corresponding detent formed on the other component that receives the protrusion, to help retain retainer 110 in retraction device 160.

[0136] In alternative embodiments, retaining device 110 may not have separate sets of catches 118 and tabs 119. For example, retaining device 110 may have one or more integral coupling members (not shown), each of which may be configured to function as both a catch for a corresponding tab 198 on positioning device 180 and a tab for a corresponding catch 168 on retracting device 160. Stated another way, the integral coupling members on retaining device 110 may be configured to matingly engage tabs 198 on positioning device 180 and catches 168 on retracting device 160.

[0137] In alternative embodiments (not shown), the relative positions of corresponding catches and tabs may be switched. For example, positioning device 180 may have one or more catches that can matingly engage with one or more tabs positioned on retaining device 110. Similarly, retraction device 160 may have one or more tabs that can matingly engage with one or more catches positioned on retaining device 110.

[0138] 5A-5D illustrate the use of complementary tabs and catches to implement the coupling mechanisms between the retaining device 110 and the positioning device 180, and between the retracting device 160 and the retaining device 110, it should be understood that the depicted embodiments are for illustrative purposes only and not limiting. Other coupling mechanisms, such as clips, hooks, locks, keys, claps, snaps, buttons, buckles, zippers, hook-and-loop fasteners, magnets, etc., can also be employed, either individually or in combination, to achieve the coupling between the retaining device 110 and the positioning device 180, and between the retracting device 160 and the retaining device 110.

[0139] holding device The retention device 110 is configured to hold the prosthetic heart valve 10 in an expanded configuration and may be configured to insert the prosthetic heart valve 10 into the contraction device 160 so that the prosthetic heart valve 10 can be contracted at the valve mounting portion 62 of the delivery device 50.

[0140] In some embodiments, the retention device 110 is configured to secure the prosthetic heart valve 10 to the retention device 110 when the prosthetic heart valve 10 is in the expanded configuration, and the prosthetic heart valve 10 can be retracted from the expanded configuration with a retraction device. One or more retention members may be included that are configured to release the prosthetic heart valve 10 from the retention device 110 when compressed into a compressed configuration.

[0141] While the embodiments of retention device 110 described below include valve alignment portions and valve retaining portions arranged in particular structural configurations, it should be understood that other structural configurations can achieve the same functions and are within the scope of this disclosure. For example, in some embodiments, the valve alignment portion can be disposed within the valve retaining portion. In some embodiments, the valve alignment portion and the valve retaining portion can be integral and need not be separable from one another. In some embodiments, the retention members can be positioned on any portion of retention device 110. In some embodiments, the retention members can each comprise an axially extending extendable beam that can be axially extended and retracted in a telescoping manner.

[0142] 7A-7C, retention device 110 may include a first portion (also referred to as a "valve alignment portion") 120 and a second portion (also referred to as a "valve retaining portion") 140. As described below, valve retaining portion 140 may be coaxially inserted into valve alignment portion 120. Furthermore, valve retaining portion 140 may be moved proximally or distally relative to valve alignment portion 120 along central axis 112.

[0143] 7B, the valve retaining portion 140 may include a proximal plate 150 that may have a generally cylindrical shape except for having a cavity 152 extending from an outer periphery 154 of the proximal plate 150 through the central axis 112. The cavity 152 may have a narrower width (e.g., inner width W2) near the central axis 112 and a wider width (e.g., outer width W2') near the periphery.

[0144] Valve retention portion 140 may further include a plurality of valve retention members 142a, 142b, 142c (three shown), collectively referred to as retention members 142. Valve retention portion 140 may also include a plurality of extending arms 146a, 146b, 146c, 146d (four shown), collectively referred to as arms 146, that extend axially from the distal surface of plate 150. As shown in FIG. 7A , each retention member 142 may include a cantilever beam 145 extending axially from the distal surface of plate 150 and a protrusion 144 extending radially outward from a distal end portion of beam 145. Retention members 142 are configured to releasably retain prosthetic valve 10 in retention device 110, as described further below. The arms 146 are configured to engage with the retraction jaws 170 of the retraction device 160, which create movement of the valve retention portion 140 relative to the valve alignment portion 120 during the retraction process, disengaging the retention member 142 from the prosthetic heart valve 10, as further described below.

[0145] The retention members 142 may be circumferentially positioned relative to one another in a generally uniform pattern. For example, Figures 7A-7C show three retention members 142 circumferentially spaced approximately 120 degrees apart from one another. Two of the retention members 142a, 142c may be symmetrically positioned on opposite sides of the cavity 152, and the third retention member 142b may be diametrically opposed to the cavity 152.

[0146] The arms 146 may be circumferentially positioned relative to one another in a generally uniform pattern. For example, Figures 7A-7C show four arms 146 that are circumferentially spaced approximately 90 degrees from one another. The four arms 146 may be positioned generally symmetrically around the cavity 152 (i.e., two arms 146a, 146b are positioned on one side and two arms 146c, 146d are positioned on opposite sides of the cavity 152).

[0147] In some embodiments, at least one arm 146 can be circumferentially disposed between a pair of adjacent retention members 142. For example, in the depicted embodiment, two arms 146a, 146d near the upper edge of cavity 152 are positioned between two retention members 142a, 142c, one arm 146b is positioned between retention members 142a and 142b, and one arm 146c is positioned between retention members 142b and 142c.

[0148] As shown in Figure 7C, valve alignment portion 120 may include a body 130 and a flange 116 coupled to a proximal end of body 130. Body 130 may have a generally cylindrical shape except for having a cavity 132 extending from an outer periphery 134 of body 130 through central axis 112. Referring to Figure 7B, cavity 132 may have a narrower width (e.g., inner width W1) near central axis 112 and a wider width (e.g., outer width W1') near the periphery.

[0149] Generally, referring to FIG. 7B , the diameter D1 of the body 130 of the valve alignment portion 120 can be greater than the diameter D2 of the proximal plate 150 of the valve retaining portion 140. Meanwhile, the width of the cavity 132 of the valve alignment portion 120 can be less than the width of the cavity 152 in the valve retaining portion 140 (e.g., W1 <W2およびW1'<W2')。

[0150] 7C and 8 , body 130 of valve alignment portion 120 may define a hollow interior space 136 that opens to a proximal face of the body. Interior space 136 may be sized and shaped to accommodate valve retention portion 140, including retention member 142, arm 146, and proximal plate 150. As shown in FIG. 8 , when there is proper alignment between cavity 152 of valve retention portion 140 and cavity 132 of valve alignment portion 120, valve retention portion 140 may be configured to slide into and / or out of hollow interior space 136 through the proximal opening in the front face of body 130.

[0151] Body 130 may further have a distal surface 122 that defines the walls of hollow interior space 136. As shown, distal surface 122 may include a plurality of openings 124 (e.g., four openings 124a, 124b, 124c, and 124d are shown), each sized, shaped, and positioned to receive a distal end portion of a plurality of arms 146 of valve retaining portion 140. Body 130 may also include a plurality of auxiliary openings 126 (e.g., three auxiliary openings 126a, 126b, and 126c are shown), each sized, shaped, and positioned to receive a distal end portion of a plurality of retention members 142 of valve retaining portion 140.

[0152] The auxiliary openings 126 may be recessed proximally relative to and adjacent to the distal surface 122. The auxiliary openings 126 may be radially longer than the plurality of openings 124. Each of the auxiliary openings 126 may extend from the outer periphery 134 into a cavity 132 in the body 130.

[0153] The circumferential positions of the apertures 124 and auxiliary apertures 126 may be configured to generally match the circumferential positions of the corresponding arms 146 and retention members 142, respectively.

[0154] For example, the multiple apertures 124 may be circumferentially positioned relative to one another in a generally uniform pattern. As shown in Figure 7B, four apertures 124 may be circumferentially spaced approximately 90 degrees from one another, and the four apertures 124 may be generally symmetrically positioned around the cavity 132 (i.e., two apertures 124a, 124b are positioned on one side and two apertures 124c, 124d are positioned on opposite sides of the cavity 132).

[0155] Similarly, the auxiliary openings 126 may be circumferentially positioned relative to one another in a generally uniform pattern. As shown, three auxiliary openings 126 may be circumferentially spaced approximately 120 degrees apart from one another. Two of the auxiliary openings 126 a, 126 c may be symmetrically positioned on opposite sides of the cavity 132, and the third auxiliary opening 126 b may be diametrically opposed to the cavity 132.

[0156] In certain embodiments, distal face 122 may further include a plurality of recesses 128, each of which may extend from outer periphery 134 into cavity 132 of body 130. As depicted in FIG. 7B , for example, two recesses 128 may be positioned symmetrically on either side of third auxiliary opening 126b, each forming an angle of approximately 60 degrees with third auxiliary opening 126b.

[0157] 7A , the valve retaining portion 140 can be inserted into the valve alignment portion 120 such that the arms 146 can extend through the corresponding openings 124 and the retention members 142 can extend through the corresponding auxiliary openings 126. Thus, distal movement of the valve retaining portion 140 relative to the valve alignment portion 120 can push the distal end portions of the arms 146 and the retention members 142 distally against the distal face 122 of the valve alignment portion 120. Conversely, proximal movement of the valve retaining portion 140 relative to the valve alignment portion 120 can retract the distal end portions of the arms 146 and the retention members 142 proximally against the distal face 122 of the valve alignment portion 120.

[0158] 7A-7C show four arms 146 (and four corresponding apertures) and three retention members 142 (and three corresponding auxiliary apertures 126), it should be understood that any number of arms (and corresponding apertures) and any number of retention members (and corresponding auxiliary apertures) may be used. Furthermore, the arms (and corresponding apertures) and retention members (and corresponding auxiliary apertures) need not be equally circumferentially spaced from one another.

[0159] Valve holder boundary As previously described, a radially expandable and compressible prosthetic implant may be releasably coupled to the retention device 110. Specifically, a prosthetic implant, such as a prosthetic heart valve 10, may be releasably coupled to the valve retention portion 140 and positioned distally relative to the valve positioning portion 120 of the retention device 110.

[0160] For example, Figures 8 and 9A show different views of the retention device 110 holding the prosthetic heart valve 10 in an expanded configuration. Figure 9B shows the retention device 110 after the prosthetic heart valve 10 has been removed from the retention device 110 and deflated in the balloon 54 of the delivery device 50.

[0161] When the prosthetic heart valve 10 is in the expanded configuration, the diameter D of the prosthetic heart valve 10 E may generally be greater than the inner width W1 of the cavity 132 (see, for example, FIG. 9A). Thus, the retention device 110 can prevent proximal movement of the prosthetic heart valve 10 when the prosthetic heart valve 10 is in the expanded configuration. However, when the prosthetic heart valve 10 is in the compressed configuration, the diameter D C may be less than the inner width W1 of the cavity 132 (see, e.g., FIG. 9B). Thus, after crimping, the delivery device 50, together with the crimped prosthetic heart valve 10 therein, can be retracted proximally from the retention device 110 through the cavity 132.

[0162] In some embodiments, the retention device 110 may include a biasing mechanism that biases the valve retaining portion 140 proximally relative to the valve alignment portion 120. In one example, Figure 8 shows two biasing members 138 positioned on the valve retaining portion 140 abutting respective adjacent surfaces positioned on the valve alignment portion 120, which may be in the form of piston members 148.

[0163] When the retention member 142 is coupled to the prosthetic heart valve 10, a biasing member 138, such as a spring plate or biasing spring, can be preloaded and exert a biasing force against the contacting piston member 148. When the retention member 142 is pressed inward by the collapsing jaws 170 against the prosthetic heart valve 10, the biasing force from the biasing member 138 moves the valve retention portion relative to the valve alignment portion, moving the retention arms proximally from the prosthetic valve. The biasing mechanism can be implemented using any mechanical and / or non-mechanical means, such as electromagnetic repulsion generated between two magnets (not shown) with like poles. Also, any number of biasing members can be employed in the retention device. The biasing members can be of a configuration separate from the valve alignment portion 120 and the valve retention portion 140.

[0164] FIG. 10 illustrates a portion of the bond interface between the prosthetic heart valve 10 and the retention device 110, according to one embodiment. 1 shows an enlarged view of the prosthetic heart valve 10. The prosthetic heart valve 10 is shown in an expanded configuration defining an interior space 35.

[0165] As previously mentioned, each retention member 142 may include a protrusion 144 extending radially outward from a distal end portion of a beam 145. Each of the cantilever beams 145 may be preloaded or biased in an outward direction. Thus, each of the protrusions 144 may extend from the interior space 35 of the prosthetic heart valve 10, through a portion of the prosthetic heart valve, to a location outside of the prosthetic heart valve 10 when the prosthetic heart valve 10 is in the expanded configuration. In this manner, the retention member 142 may hook the prosthetic heart valve 10 to the retention device 110.

[0166] In some embodiments, each protrusion 144 may include a base portion 144b that joins with the distal end portion of the beam 145 and a head portion 144h that protrudes radially outward relative to the base portion 144b. In some embodiments, the base portion 144b may have a proximal surface 144v that faces radially outward and extends generally perpendicular to the beam 145. In some embodiments, the head portion 144h may have a proximal inclined surface 144s that is inclined or curved toward the tip portion 144t. The proximal inclined surface 144s may extend from the proximal vertical surface 144v to the tip portion 144t.

[0167] In some embodiments, base portion 144b has a larger longitudinal dimension W than tip portion 144t. D In some embodiments, the protrusion 144 may have a longitudinal dimension W D The tip portion 144t may have a generally tapered shape such that the diameter of the tip portion 144t gradually decreases from the base portion 144b to the tip portion 144t.

[0168] 10 , the proximal end portion of the prosthetic heart valve 10 can be defined by a plurality of proximal nodes or apexes 38 of the frame 12, each of which can be formed at the intersection of two circumferentially adjacent diagonal struts 28 of the frame. As shown, each protrusion 144 can extend radially outward through an adjacent open cell 30. Also, the beams 145 can be preloaded to bias radially outward against the inner surface of the frame 12. Thus, the retention members 142 in the illustrated embodiment can securely hold the frame 12 (and thus the prosthetic valve) to the retention device via the outward bias of the retention members and by the protrusions 144 hooking onto the frame struts at selected apexes 38.

[0169] As previously mentioned, one or more biasing members may be incorporated into the retention device 110 to bias the valve retention portion 140 proximally against the valve alignment portion 120. Additionally, the proximal surface 144v of the base portion 144b may engage the adjacent proximal node 38 and the two diagonal struts 28 that intersect at that node 38. In this manner, the biasing members urge the retention member 142 proximally, which further urges the frame 12 against the distal surface 122 of the valve alignment portion 120.

[0170] 10 , at least some of the proximal nodes 38 (e.g., 38 a) are in direct contact with the distal surface 122 of the valve alignment portion 120 of the retention device 110. Thus, despite a force (in the proximal direction) applied to the frame 12 by the protrusions 144, the distal surface 122 can prevent proximal movement of the frame 12 unless the prosthetic heart valve 10 is in a compressed configuration (note: in the compressed configuration, all of the proximal nodes 38 are positioned within the cavity 132 because, as described above, the diameter of the prosthetic heart valve 10 is smaller than the inner width of the cavity 132). Nevertheless, the force applied by the retention member 142 can keep those proximal nodes 38 a in contact with the distal surface 122.

[0171] In some embodiments, some of the proximal nodes 38 (e.g., 38b) may be aligned with the voids 132, auxiliary openings 126, or recesses 128 so that they do not directly contact the distal surface 122. Nevertheless, all of the proximal nodes 38a, 38b may be generally flush with the distal surface 122.

[0172] 10 , each arm 146 of the retention device 110 may include a sloped surface 147 along a distal end portion of the arm 146. The sloped surface 147 may be oriented to face somewhat radially outward and somewhat axially distally. When the prosthetic heart valve 10 is in the expanded configuration, at least an inner portion 147i of the sloped surface 147 may extend into the interior space 35 of the prosthetic heart valve 10. Additionally, an outer portion 147o of the sloped surface 147 may be positioned radially outward relative to the frame 12 and distal to the distal surface 122 of the valve positioning portion 120.

[0173] In some embodiments, the retention member 142 may extend radially outward relative to the arms 146 when the prosthetic heart valve 10 is in the expanded configuration. For example, the tip portion 144t of the protrusion 144 may extend radially outward relative to the angled surfaces 147 (including the outer portions 147o) of the arms 146 when the prosthetic heart valve 10 is in the expanded configuration.

[0174] As the prosthetic heart valve 10 is crimped with the crimping device 160 from the expanded configuration to the compressed configuration, the jaws 170 of the crimping device 160 push the retention members 142 of the retainer 110 radially inward into the interior space 35 of the prosthetic heart valve 10. The jaws 170 also move the arms 146, thereby moving the valve retention portion 140 axially proximally relative to the prosthetic heart valve 10, until the retention members 142 are retracted from the prosthetic valve. Continued movement of the jaws 170 causes the prosthetic valve to crimp in the delivery device. In this manner, when the crimping device 160 is actuated, the prosthetic heart valve is released from the valve retainer 110. This process is described further below.

[0175] 11A shows the prosthetic heart valve 10 coupled to another embodiment of a retention device 210, which has a similar structure and valve interface to the retention device 110. For example, the retention device 210 may also include the valve alignment portion 120 and the valve retention portion 140 as shown in FIGS. 7A-7C, except for some additional features as described below.

[0176] 11A, the retention device 210 may include a sloped boundary for each of the retention members 142. Specifically, the valve alignment portion 120 of the retention device 210 may include a plurality of inwardly extending sloped protrusions 260. Each sloped protrusion 260 may be positioned radially outward relative to a corresponding retention member 142. Each sloped protrusion 260 may have a sloped inner side surface 262 oriented to face somewhat radially inward and somewhat axially proximally.

[0177] Correspondingly, each retention member 142 may have an angled protrusion 264 adjacent to the corresponding protrusion 260. Each angled protrusion 264 may have an angled outer surface 266 oriented to face somewhat radially outward and somewhat axially distally. The angled outer surface 266 may be positioned, sized, and shaped complementarily to the corresponding angled inner surface 262 of the adjacent protrusion 260. Thus, the angled protrusion 260 may be configured to interface with the corresponding angled protrusion 264 by sliding engagement between the angled inner surface 262 and the angled outer surface 266.

[0178] The retention device 210 may also include a biasing mechanism that biases the valve retaining portion 140 proximally relative to the valve alignment portion 120. Figure 1 IB shows an alternative embodiment of the biasing mechanism, in which a biasing member 238 positioned on the valve alignment portion 120 of the retention device 210 interfaces with a corresponding piston member 248 positioned on the valve retaining portion 140 of the retention device 210. When the retention member 142 is coupled to the prosthetic heart valve 10, the biasing member 238 is pushed distally by the piston member 248 to a loaded position. When the retention member 142 is released from the prosthetic heart valve 10, the biasing member 238 returns to its unloaded position, pushing the piston member 148 in a proximal direction.

[0179] To load the prosthetic heart valve 10 into the retainer 210, the valve retention portion 140 can be moved distally relative to the valve alignment portion 120. Due to the angled interface between the retention member 142 and the corresponding angled protrusion 260, the distal end portion of the retention member 142 (including the protrusion 144) is angled radially inward so as to be easily inserted into the interior space 35 of the prosthetic heart valve 10 when the prosthetic heart valve 10 is in the expanded configuration. Then, as the cantilever beam 145 tilts outward and returns toward its preloaded position, the protrusions 144 can "grab" the prosthetic heart valve 10 by extending from the interior space 35 of the prosthetic heart valve 10 through the openings in the frame 12 to a location outside the prosthetic heart valve 10.

[0180] Conversely, when the retention member 142 is released from the prosthetic heart valve 10, for example, during a retraction process as described more fully below, the valve retention portion 140 may be urged to move proximally relative to the valve alignment portion 120 under the force of the biasing member 238 and / or through contact between the retraction jaws 170 and the arms 146 (the angled arms 146 are optional in the embodiment of FIGS. 11A-11B). As the valve retention portion 140 is moved proximally, the distal end portion of the retention member 142 moves radially inward relative to the prosthetic valve to release it from the frame cells 30 due to the angled surfaces. Continued movement of the valve retention portion 140 retracts the distal end portion of the retention member 142 from the interior space 35 of the prosthetic heart valve 10.

[0181] The shrinking process 12A-12B show a method of retracting the prosthetic heart valve 10 in the delivery device 50, according to one exemplary embodiment. In the depicted embodiment, when the retention device 110 is coupled to the retraction device 160, the proximal edges of the jaws 170 of the retraction device 160 are aligned with the distal face 122 of the valve alignment portion 120.

[0182] As shown in FIG. 12A , during actuation of the retraction device 160, the closing jaws 170 of the retraction device 160 may initially contact the tip portion 144t of each protrusion 144 (which is on the outside of the prosthetic heart valve). As the jaws 170 further close to reduce the size of the retraction opening 174, the jaws press the protrusions 144 radially inward against the frame 12. After the proximal surface 144v of the base portion 144b is pressed into the interior space 35 of the prosthetic heart valve 10, the gripping force exerted by the protrusions 144 on the frame 12 decreases because the frame 12 now interfaces with the proximal inclined surface 144s of the head portion 144h. Because the biasing member in the retention device 110 urges the retention member 142 in the proximal direction, the protrusions 144 slide down and release their grip on the frame 12 as they move proximally under the force of the biasing member.

[0183] As the jaws 170 continue to close radially inward, the jaws 170 interface with and slide on the inclined surfaces 147 of the arms 146. For example, the closing jaws 170 can interface with the outer portions 147o of the inclined surfaces 147 and slide radially inward on the inclined surfaces 147. As a result, the closing jaws 170 can exert a force on the inclined surfaces 147, moving the arms 146, and thus the retention member 142, in a proximal direction relative to the valve alignment portion 120. As the distal end portions of the arms 146 retract proximally from the interior space 35 of the prosthetic heart valve 10, the closing jaws 170 can interface with and apply a radially inward pressure to the frame 12. As a result, the prosthetic heart valve 10 can be compressed radially. When the arms 146 (and retention members 142) are fully ejected from the interior space 35, the prosthetic heart valve 10 can be fully collapsed into a compressed configuration in the delivery device.

[0184] Retracting the prosthetic heart valve 10 causes the frame 12 to elongate axially. However, the frame 12 can elongate in the distal direction (i.e., the direction indicated by arrow A in FIG. 12B ) because a proximal end portion of the prosthetic heart valve 10 can remain in contact with the distal surface 122 of the valve alignment portion 120 when the prosthetic heart valve 10 is radially compressed from the expanded configuration with the retraction device 160. As previously described, unless the prosthetic heart valve 10 is in the compressed configuration, at least a portion of the proximal nodes 38 a of the frame 12 abuts the distal surface 122 of the valve alignment portion 120. Thus, the distal surface 122 can serve as a barrier to prevent the frame 12 from elongating proximally during the retraction process.

[0185] As shown in FIGS. 12A-12B , when the retention device 110 is coupled to a positioning device 180 attached to the delivery device 50, the distal surface 122 of the valve alignment portion 120 is positioned at the valve seating portion 122. The distal end 66 of the valve mounting portion 62 may be configured to be aligned with the proximal end 68 of the valve mounting portion 62. Thus, the proximal end of the prosthetic heart valve 10 may be precisely aligned with the proximal end 68 of the valve mounting portion 62 during the crimping process. As previously described, the axial length L of the valve mounting portion 62 may be approximately equal to the axial length of the prosthetic heart valve 10 when the prosthetic heart valve 10 is in the compressed configuration. Because the prosthetic valve is prevented from elongating in the proximal direction, the distal end of the prosthetic heart valve 10 may be precisely aligned with the distal end 66 of the valve mounting portion 62 when the prosthetic heart valve 10 is fully compressed. Thus, the disclosed device assemblies and methods can facilitate quick, easy, and precise crimping of the prosthetic heart valve 10 on, for example, the balloon 54 of the delivery device 50.

[0186] Alternative Embodiments 15A-15B show a prosthetic heart valve frame 12 coupled to another embodiment of a retention device 310, the retention device 310 having a different valve retention / release mechanism. The retention device 310 comprises a valve alignment portion 320 and one or more valve retention members 340. In the depicted embodiment, three valve retention members 340 are shown, but it should be understood that one, two, or four or more valve retention members 340 may be included. Each valve retention member 340 may comprise a head portion 342, a body portion 344, and a tail portion 346.

[0187] Valve alignment portion 320 may have a body portion 330 and a flange 316 coupled to a proximal end of body portion 330. Flange 316 may be configured to releasably couple to positioning device 180 and / or retraction device 160, as previously described. Body portion 330 may have a generally cylindrical shape except for having a void 332 extending through its central axis from an outer periphery 334 of body portion 330.

[0188] Body portion 330 has a distal surface 322 that may include a plurality of apertures 324. For example, in the embodiment depicted in Figure 15A, three apertures 324 are circumferentially spaced approximately 120 degrees apart. Two of the apertures 324 may be symmetrically positioned on opposite sides of cavity 332, and the third aperture 324 may be diametrically opposed to cavity 332.

[0189] Body portion 330 may have a plurality of inner panels 326 positioned between distal face 322 and flange 316 and extending radially inward from outer periphery 334. As shown in FIG. 15A , each inner panel 326 may be positioned and oriented proximally opposite a corresponding opening 324.

[0190] As described below, the valve retaining member 340 can be transitioned from a valve-engaged position, as shown in Figures 15A-15B, through a valve-released position, as shown in Figure 15C, to a stowed position, as shown in Figure 15D.

[0191] In the valve-engaging position (see, e.g., FIGS. 15A-15B ), each valve retaining member 340 can extend axially from a corresponding inner panel 326 through a corresponding opening 324 in the distal face 322. A head portion 342 projects radially outward relative to a body portion 344 and a tail portion 346, which is coupled to a corresponding inner panel 326. Specifically, each head portion 342 can extend radially outward through an open frame cell of the prosthetic heart valve, thereby enabling the head portion 342 to grip a strut portion of the frame 12 and retain the prosthetic heart valve in a radially expanded configuration.

[0192] In the depicted embodiment, each inner panel 326 includes a shelf member 336 configured to releasably secure a tail portion 346 of valve retainer member 340 to shelf member 336. For example, a proximal end portion of tail portion 346 can be received in a groove 338 positioned in the middle of shelf member 336, and a ridge 339 surrounding groove 338 can prevent tail portion 346 from disengaging from groove 338 when no or insufficient force is applied to tail portion 346.

[0193] In some embodiments, the body portion 344 of the valve retaining member 340 is hingedly connected to the body portion 330 of the valve alignment portion 320. For example, in the embodiment depicted in Figures 15A-15B, the body portion 344 of the valve retaining member 340 includes a hinge 345 that extends across the adjacent opening 324 and is coupled to the distal face 322. In that way, when the tail portion 346 of the valve alignment portion 320 is removed from the shelf member 336 (e.g., disengaged from the groove 338), the valve alignment portion 320 can pivot about the hinge 345.

[0194] Collapsing of the prosthetic valve may be accomplished by actuation of the collapsing device 160, as previously described. The closing jaws 170 of the collapsing device 160 may push the head portion 342 of the valve retainer 340 radially inward against the frame 12. After the head portion 342 loses grip on the frame 12, the valve retainer 340 may be transitioned to a valve release position (see, e.g., FIG. 15C ), and the prosthetic valve may be collapsed into a radially compressed configuration.

[0195] When closing jaws 170 apply sufficient force to head portion 342, the force is transferred to tail portion 346, allowing tail portion 346 to overcome the resistance of ridge 339 and disengage from shelf 336. In some embodiments, tail portion 346 may comprise a resilient material such that it can flex slightly in response to the applied force, thereby facilitating disengagement of tail portion 346 from shelf 336.

[0196] As the jaws 170 continue to close during the contraction process, the jaws 170 can continue to push the head portions 342 radially inward, causing the corresponding valve retaining members 340 to rotate about the hinges 345 until the head portions 342 are positioned proximal to the distal face 322 and the valve retaining members 340 are moved into a stowed position (see, for example, FIG. 15D).

[0197] In some embodiments, the valve retaining members 340 may include a biasing member (not shown) configured to be biased when in the valve engaging position and unbiased when in the stowed position. In this manner, the biasing force can move or facilitate the movement of the valve retaining members 340 to the stowed position after the tail portion 346 is disengaged from the shelf member 336. When all of the valve retaining members 340 are in the stowed position, the prosthetic heart valve can be fully collapsed to the compressed configuration in the delivery device.

[0198] 16A-16D show an alternative embodiment of a retention device 410 for retaining and releasing a prosthetic valve frame 12. The retention device 410 comprises a valve alignment portion 420 and one or more valve retention members 440. In the depicted embodiment, three valve retention members 440 are shown, but it should be understood that one, two, four or more valve retention members 440 may be included.

[0199] As shown in FIG. 16B, the valve alignment portion 420 can have a body portion 430 and a flange 416 coupled to a proximal end of the body portion 430. The flange 416 can be configured to releasably couple to the positioning device 180 and / or the retraction device 160, as previously described. The body portion 430 can have a generally cylindrical shape except for having a cavity 432 extending through its central axis from an outer periphery 434 of the body portion 430. The body portion 430 has a distal surface 422 that can include a plurality of openings 424. For example, FIG. 16B shows seven openings 424 in the distal surface 422.

[0200] 16A , each valve retaining member 440 can include a base portion 442, a first leg 444, and a second leg 446. The first leg 444 and the second leg 446 extend from the base portion 442 and form two cantilever beams. The distal end portion of each leg 444, 446 can be deflected by applying a force perpendicular to the leg. The base portion 442 is positioned proximal to the flange 416, and the first leg 444 and the second leg 446 can extend through the valve alignment portion 420 and further extend distally of the distal face 422 through two adjacent openings 424.

[0201] The first leg 444 is generally perpendicular to the base portion 442. A distal end portion 447 of the first leg 444 may include a ledge 448. The distance between the ledge 448 and the base portion 442 is approximately the same as or slightly longer than the axial length of the valve alignment portion 420 such that when the base portion 442 abuts or is adjacent the proximal end of the flange 416, the distal end portion 447 of the first leg 444 is distal to the distal face 422 and can bear against the distal face 422 adjacent the opening through which the first leg 444 extends. When the ledge 448 bears against the distal face 422, the valve retaining member 440 is releasably coupled to the valve alignment portion 420 and is restricted from axial movement relative to the valve alignment portion 420.

[0202] The second leg 446 includes a proximal portion 450 that is generally parallel to the first leg 444 and a distal portion 452 that is oblique to and slopes away from the first leg 444. A tip portion 454 of the distal portion 452 can extend radially outward to form a notch or hook 456 that can engage a portion of the frame 12. When the first leg 444 and the second leg 446 extend through two adjacent openings 424, the tip portion of the second leg 446 is configured to extend radially outward through an open frame cell of the prosthetic heart valve. The notch 456 in the second leg 446 can thereby grip a strut portion of the frame 12 and retain the prosthetic heart valve in a radially expanded configuration (see, for example, FIG. 16B ).

[0203] In some embodiments, frame 12 can be held away from retention device 410. For example, when frame 12 is held by valve retention member 440 in a radially expanded configuration (FIG. 16C) or during a retraction process (FIG. 16D), the proximal end of frame 12 can be spaced a predetermined distance from distal face 422.

[0204] Valve retainer member 440 may further include a biasing member 458, such as a coil spring as shown in FIG. 16D , configured to urge first leg 444 and second leg 446 in the proximal direction. In some embodiments, biasing member 458 may be coupled to the proximal portion 450 of second leg 446. In other embodiments, biasing member 458 may be coupled to first leg 444. In yet other embodiments, biasing member 458 may be coupled to both first leg 444 and second leg 446. In the illustrated embodiment, the spring is disposed around first leg 444 and second leg 446, with one end of the spring abutting an adjacent surface of base portion 442 and the opposite end of the spring abutting an adjacent surface of the proximal face of body portion 430 (the proximal face is opposite distal face 422). In this manner, the spring exerts a biasing force in a proximal direction against the base portion 442. When the biasing member 458 is in the biased position (e.g., when the spring is fully compressed) and the second leg 446 is engaged with the frame 12, the ledge 448 on the first leg 444 can bear against and engage the distal surface 422 to keep the second leg 446 engaged with the frame 12 and prevent proximal movement of the legs 444, 446 against the biasing force of the biasing member 458.

[0205] Retraction of the prosthetic valve may be accomplished by actuation of the retraction device 160, as previously described. In some embodiments, the closing jaws 170 of the retraction device 160 may press radially inward against both the tip portion 454 of the second leg 446 and the distal end portion 447 of the first leg 444 at approximately the same time. Pressing against the tip portion 454 of the second leg 446 may cause the notch 456 to lose its grip on the frame 12, and pressing against the distal end portion 447 of the first leg 444 may cause the ledge 448 to release from the distal surface 422.

[0206] When the shelf 448 is released from the distal face 422, the biasing member 458 is also released, allowing the biasing member 458 to return to its unbiased position. The biasing member 458 can press against the base portion 442 in a proximal direction, thereby moving the legs 444, 446 of the valve retaining member 440 proximally relative to the valve alignment portion 420 to a location proximal to the frame 12. When all of the valve retaining members 440 are moved from the interior space of the frame 12, the prosthetic core The valve may be fully collapsed into a compressed configuration in the delivery device.

[0207] In other embodiments, the closing jaws 170 of the retraction device 160 can press radially inward only against the tip portion 454 of the second leg 446 (and cause the notch 456 to lose its grip on the frame 12) without pressing against the distal end portion 447 of the first leg 444. For example, when the closing jaws 170 apply sufficient force to the tip portion 454 of the second leg 446, the first leg 444 can also deflect radially such that the ledge 448 can be released from the distal surface 422. In some embodiments, the radial deflection of the first leg 444 can be caused by the transmission of force applied to the tip portion 454 of the second leg 446 through the base portion 442. In other embodiments, when the second leg 446 is sufficiently deflected by a contracting force, the deflected second leg 446 can press against the first leg 444, causing the first leg 444 to deflect.

[0208] assembly packaging In the following, the holding device 110 is used as an example to describe the assembly packaging, but it should be understood that the other holding devices mentioned above (e.g., 210, 310, and 410) may be used according to the same principles.

[0209] In some embodiments, the prosthetic heart valve 10 in the expanded configuration may be pre-attached by the manufacturer to the retention device 110. The assembly consisting of the retention device 110 and the prosthetic heart valve 10 pre-attached to the retention device may be placed inside a container for shipment to a distributor or end user.

[0210] 13 shows one embodiment of the container 104. In some embodiments, the container 104 may be coupled to a flange 105. As depicted, the container 104 may have an upper opening 106 that may be closed by a hinged cap 107 with a pull tab 108. Alternatively, the container may have a threaded opening that may be closed by a threaded cap (not shown). The container 104 may include an anchoring mechanism 109 (e.g., an internal skeleton or frame structure) configured to releasably secure the retention device 110 within the container 104 such that the retention device 110 cannot move relative to the container 102 when coupled to the anchoring mechanism. Thus, the container 104 may be used for safe storage and transportation of the assembly of the retention device 110 and the prosthetic heart valve 10.

[0211] The container 104 (including the cap 107) can be configured to be leak-tight and / or airtight. In an exemplary embodiment, the container 104 can be filled with a preservation / hydration liquid, such that the retention device 110 and prosthetic heart valve 10 held in the container 104 can be submerged in the preservation / hydration liquid. Specifically, in certain embodiments, it is desirable to keep the leaflets 18 of the prosthetic valve submerged in the preservation liquid during shipping and storage. After the manufacturing process and prior to implantation, the prosthetic heart valve 10 can be preconditioned with the retention device 110 as required by the valve structure (leaflets).

[0212] 14 shows an exemplary packaging assembly 40 (which may also be referred to as a "tool kit") that may include one or more components. As depicted, packaging assembly 40 may include a tray 42 having multiple recesses 43 configured to hold, without limitation, one or more of the following devices: a delivery device 50, a retraction device 160, a positioning device 180, a loading device 44, a syringe 46 for injecting inflation fluid into port 53 to inflate balloon 54, a timer 48, etc.

[0213] As shown, the positioning device 180 may be pre-loaded onto the shaft of the delivery device 50. The tray 42 may also include one or more recesses or wells 45 configured to hold contrast saline and / or heparin saline, as needed. The tray 42, along with the various components held therein, may be sterilized and housed within an enclosure (such as a sealed plastic enclosure) that maintains an internal sterile environment during shipping and storage. In other embodiments, the packaging assembly 40 may also include a container 104 that holds the prosthetic heart valve 10 and the retention device 110.

[0214] In some embodiments, the prosthetic valve and retention device assembly can be pre-coupled to a positioning device 180, which can be pre-loaded onto the delivery device as shown in FIG. 14. The prosthetic valve, retention device, and positioning device and distal end portion of the delivery device can be housed within a wet storage compartment that contains hydration fluid for the prosthetic valve leaflets, with the wet storage compartment housed within a larger dry storage compartment that houses the other compartments shown in FIG. 14.

[0215] As previously mentioned, the prosthetic valve leaflets 18 (typically made from bovine pericardial tissue or other natural or synthetic tissue) may be "dry leaflets" that are processed during the manufacturing process to be completely or substantially dehydrated and capable of being stored without a hydrating fluid. As used herein, "dry" or "substantially dry" means that all or nearly all of the interstitial water has been removed from the tissue. Methods for preparing tissue leaflets for dry storage are disclosed in U.S. Pat. No. 8,007,992 and U.S. Patent Publication No. 2009 / 0164005, filed December 18, 2008, both of which are incorporated herein by reference.

[0216] If the prosthetic valve includes dry tissue leaflets, the prosthetic valve can be pre-coupled to the retention device 110, which can be further pre-coupled to the positioning device 180, which can be further pre-loaded onto the delivery device 50. All of these components can be packaged together in the same sterile, dry enclosure.

[0217] Also, as detailed above, in embodiments in which the prosthetic valve, retention device, and positioning device are all attached to a delivery device for shipping and storage, the retention device and positioning device may be two indivisible parts of a larger, comprehensive retention and positioning device.

[0218] In addition to the embodiments described above, the following list of numbered examples is also within the scope of this disclosure.

[0219] List of Examples

[0220] 1. An assembly comprising a retention device and a non-self-expandable prosthetic heart valve radially compressible from an expanded configuration to a compressed configuration, the retention device configured to retain the prosthetic heart valve in the expanded configuration and configured to insert the prosthetic heart valve into the crimping device so that the prosthetic heart valve can be crimped in a valve mounting portion of a delivery device.

[0221] 2. The assembly of Example 1, wherein the retention device comprises one or more retention members configured to secure the prosthetic heart valve to the retention device when the prosthetic heart valve is in an expanded configuration and configured to release the prosthetic heart valve from the retention device when the prosthetic heart valve is compressed from the expanded configuration to a compressed configuration in the valve-mounting portion of the delivery device.

[0222] 3. The assembly of Example 2, wherein a distal portion of each retention member extends distally to the prosthetic heart valve when the prosthetic heart valve is in the expanded configuration, and wherein a distal portion of each retention member is positioned proximal to the prosthetic heart valve when the prosthetic heart valve is in the compressed configuration.

[0223] 4. The assembly of Example 2 or Example 3, wherein each of the retention members has a protrusion extending radially outward at a distal end of the retention member, each protrusion configured to extend radially outward into an opening in the prosthetic heart valve when the prosthetic heart valve is in the expanded configuration.

[0224] 5. The retaining device comprises a first portion and a second portion, and one or more retention members are distal from the second portion. 5. The assembly of any one of Examples 2 to 4, wherein the first portion extends axially and is axially movable relative to the distal surface of the first portion.

[0225] 6. The assembly of Example 5, wherein the prosthetic heart valve elongates in one direction when the prosthetic heart valve is contracted from the expanded configuration to the compressed configuration such that the distal surface of the first portion prevents the prosthetic heart valve from elongating proximally while allowing the prosthetic heart valve to elongate distally.

[0226] 7. The assembly of Example 5 or Example 6, wherein the retention member is configured to extend distally relative to the distal surface of the first portion to couple to the prosthetic heart valve in the expanded configuration, and is configured to move proximally relative to the distal surface of the first portion after releasing the prosthetic heart valve when the prosthetic heart valve is radially compressed.

[0227] 8. The assembly of Example 7, wherein when the prosthetic heart valve is retained by the retention device, a proximal end portion of the prosthetic heart valve abuts a distal surface of the first portion when the prosthetic heart valve is in an expanded configuration and secured to the retention device by the retention member.

[0228] 9. The assembly of any one of Examples 5 to 8, wherein the second portion of the retention device comprises one or more angled protrusions corresponding to the one or more retention members, each angled protrusion abutting a corresponding angled member on the retention member such that the retention member can slide distally into the interior space of the prosthetic heart valve when the prosthetic heart valve is in the expanded configuration.

[0229] 10. The assembly of any one of Examples 5 to 9, wherein the retainer comprises one or more biasing members configured to bias the second portion proximally relative to the first portion.

[0230] 11. The assembly of any one of Examples 5 to 10, wherein the second portion comprises one or more arms, the distal end of each arm extending distally relative to the distal face of the first portion when the retention member is coupled to the prosthetic heart valve.

[0231] 12. The assembly of Example 11, wherein at least one arm is circumferentially disposed between a pair of adjacent retention members, the retention members extending radially outward relative to the arms when the prosthetic heart valve is in an expanded configuration, and the retention members compress radially inward when the prosthetic heart valve is radially compressed, radially aligning with at least a portion of the arms.

[0232] 13. The assembly of Example 11 or Example 12, wherein a distal end of each arm comprises an inclined surface configured to interface with the retraction jaw such that radially inward movement of the retraction jaw exerts a force on the inclined surface, urging the corresponding arm to move proximally relative to the first portion.

[0233] 14. The assembly of any one of Examples 1 to 13, further comprising a positioning device configured to be releasably coupled to the shaft of the delivery device and to be releasably coupled to the retention device.

[0234] 15. The assembly of example 14, wherein the positioning device comprises a body having an inner surface defining an axially extending passage sized to form an interference fit with a portion of the shaft.

[0235] 16. The assembly of example 15, wherein the portion of the shaft is positioned distally at a predetermined distance relative to the valve mounting portion.

[0236] 17. The assembly of Example 15 or Example 16, wherein the inner surface of the body comprises an array of circumferentially oriented grooves extending from the proximal end of the body to the distal end of the body such that sterilizing gas can permeate through the grooves and into the passageway when the body is coupled to the shaft.

[0237] 18. The assembly of any one of Examples 14 to 17, wherein the retaining device comprises one or more first coupling members mateable with one or more second coupling members of the positioning device.

[0238] 19. The assembly of any one of Examples 1 to 18, wherein the assembly further comprises a retraction device configured to radially compress the prosthetic heart valve from the expanded configuration to the compressed configuration, and wherein the retention device comprises one or more third coupling members mateable with one or more fourth coupling members of the retraction device.

[0239] 20. A system for implanting a prosthetic heart valve, the system comprising: a positioning and holding assembly configured to retain the prosthetic heart valve in an expanded configuration, mounted on a shaft of a delivery device, and to enable insertion of the prosthetic heart valve into a contraction device to contract the prosthetic heart valve in a valve mounting portion of the delivery device from a radially expanded configuration to a radially compressed configuration.

[0240] 21. The system of Example 20, wherein the positioning and holding assembly comprises a positioning portion configured to be releasably coupled to the shaft of the delivery device, and a holding portion configured to releasably hold the prosthetic heart valve in a radially expanded configuration while the prosthetic heart valve is retracted in the valve mounting portion of the delivery device.

[0241] 22. The system of example 21, wherein the positioning portion and the holding portion are separable from each other.

[0242] 23. The system of example 21, wherein the positioning portion and the holding portion are non-separable from each other.

[0243] 24. The system of Example 21, wherein the retention portion comprises one or more retention members configured to secure the prosthetic heart valve to the retention portion when the prosthetic heart valve is in an expanded configuration and configured to release the prosthetic heart valve from the retention portion when the prosthetic heart valve is retracted from the expanded configuration to a compressed configuration in the valve mounting portion of the delivery device.

[0244] 25. The system of Example 24, wherein a distal portion of each retention member extends distally to the prosthetic heart valve when the prosthetic heart valve is in the expanded configuration, and wherein a distal portion of each retention member is positioned proximal to the prosthetic heart valve when the prosthetic heart valve is in the compressed configuration.

[0245] 26. The system of Example 24 or Example 25, wherein each of the retention members has a protrusion extending radially outward at a distal end of the retention member, each protrusion configured to extend radially outward into an opening in the prosthetic heart valve when the prosthetic heart valve is in an expanded configuration.

[0246] 27. The system of any one of Examples 24 to 26, wherein the retention portion comprises a first portion and a second portion, and the one or more retention members extend distally from the second portion and are axially movable relative to a distal surface of the first portion.

[0247] 28. The system of Example 27, wherein the prosthetic heart valve elongates in one direction when the prosthetic heart valve is contracted from the expanded configuration to the compressed configuration such that the distal surface of the first portion prevents the prosthetic heart valve from elongating proximally while allowing the prosthetic heart valve to elongate distally.

[0248] 29. The system of Example 27 or Example 28, wherein the plurality of retention members are configured to extend distally relative to the distal surface of the first portion to couple to the prosthetic heart valve in the expanded configuration, and are configured to move proximally relative to the distal surface of the first portion after releasing the prosthetic heart valve when the prosthetic heart valve is radially compressed.

[0249] 30. The system of Example 29, wherein when the prosthetic heart valve is retained by the retention portion, a proximal end portion of the prosthetic heart valve abuts a distal surface of the first portion when the prosthetic heart valve is in an expanded configuration and secured to the retention portion by the plurality of retention members.

[0250] 31. The system of any one of Examples 27 to 30, wherein the second portion includes a plurality of angled protrusions corresponding to the plurality of retention members, each angled protrusion abutting a corresponding angled member on the retention member such that the retention member can slide distally into the interior space of the prosthetic heart valve when the prosthetic heart valve is in the expanded configuration.

[0251] 32. The system of any one of Examples 27 to 31, wherein the retaining portion comprises one or more biasing members configured to bias the second portion proximally relative to the first portion.

[0252] 33. The system of any one of Examples 27 to 32, wherein the second portion comprises one or more arms, the distal end of each arm extending distally relative to the distal surface of the first portion when the retention member is coupled to the prosthetic heart valve.

[0253] 34. The system of Example 33, wherein at least one arm is circumferentially disposed between a pair of adjacent retention members, the retention members extend radially outward relative to the arms when the prosthetic heart valve is in an expanded configuration, and the retention members are compressed radially inward when the prosthetic heart valve is radially compressed, radially aligning with at least a portion of the arms.

[0254] 35. The system of Example 33 or Example 34, wherein the distal end of each arm comprises an inclined surface configured to interface with a retraction jaw of the retraction device such that radially inward movement of the retraction jaw exerts a force on the inclined surface, urging the corresponding arm to move proximally relative to the first portion.

[0255] 36. The system of example 21, wherein the positioning portion comprises a body having an inner surface defining an axially extending passage sized to form an interference fit with a portion of the shaft.

[0256] 37. The system of Example 36, wherein the portion of the shaft is positioned distally at a predetermined distance relative to the valve mounting portion.

[0257] 38. The system of Example 36 or Example 37, wherein the inner surface of the body comprises an array of circumferentially oriented grooves extending from the proximal end of the body to the distal end of the body such that sterilizing gas can permeate through the grooves and into the passageway when the body is coupled to the shaft.

[0258] 39. The system of any one of Examples 20 to 38, wherein the positioning and holding assembly further comprises one or more coupling members mateable with one or more complementary coupling members of the retraction device.

[0259] 40. A method for retracting a prosthetic heart valve in a delivery device, the method comprising: coupling a retraction device to a positioning and holding assembly mounted on a shaft of the delivery device such that the prosthetic heart valve held by the positioning and holding assembly is inserted into the retraction device; and actuating the retraction device to radially compress the prosthetic heart valve in a valve mounting portion of the delivery device from an expanded configuration to a compressed configuration.

[0260] 41. The method of example 40, further comprising coupling the prosthetic heart valve in the expanded configuration to a positioning and holding assembly.

[0261] 42. Steps for mounting the positioning and holding assembly in place on the shaft of the delivery device. 42. The method of Example 40 or Example 41, further comprising: a valve mounting portion for mounting the valve to the delivery device; and wherein the predetermined location is spaced apart relative to the valve mounting portion of the delivery device.

[0262] 43. The method of example 42, wherein the positioning and holding assembly comprises a positioning portion releasably coupled to the shaft of the delivery device and a holding portion that releasably retains the prosthetic heart valve.

[0263] 44. The method of example 43, wherein the act of attaching the positioning and retaining assembly includes coupling a positioning portion to a predetermined location on the shaft of the delivery device and coupling a retaining portion to the positioning device.

[0264] 45. The method of any one of Examples 40 to 44, wherein the act of actuating the retraction device releases the prosthetic heart valve from the positioning and holding assembly.

[0265] 46. ​​The method of any one of Examples 40 to 45, wherein compression of the prosthetic heart valve causes the prosthetic heart valve to elongate in one direction such that a proximal end portion of the prosthetic heart valve is fixedly aligned with the proximal end of the valve mounting portion and a distal end portion of the prosthetic heart valve extends distally during compression until aligned with the distal end of the valve mounting portion when the prosthetic heart valve is in the compressed configuration.

[0266] 47. The method of any one of Examples 40 to 46, further comprising the step of decoupling the positioning and holding assembly from the delivery device after the prosthetic heart valve is crimped at the valve mounting portion.

[0267] 48. The method of Example 47, further comprising the step of removing the delivery device together with the prosthetic heart valve from the retraction device after the positioning and holding assembly is decoupled from the delivery device.

[0268] 49. The method of any one of Examples 40 to 48, wherein the positioning and retention assembly comprises one or more retention members configured to releasably couple to the prosthetic heart valve, and the positioning and retention assembly further comprises one or more arms, each of which extends distally into the interior space of the prosthetic heart valve when the retention member is coupled to the prosthetic heart valve.

[0269] 50. The method of example 49, wherein the act of actuating the retraction device pushes the one or more retention members radially inward to decouple the one or more retention members from the prosthetic heart valve.

[0270] 51. The method of example 49 or example 50, wherein the act of actuating the retraction device pushes one or more arms proximally relative to and away from the prosthetic heart valve.

[0271] 52. A retention device for a prosthetic heart valve, the retention device comprising one or more retention members configured to secure the prosthetic heart valve to the retention device when the prosthetic heart valve is in a radially expanded configuration and configured to release the prosthetic heart valve from the retention device when the prosthetic heart valve is compressed from the radially expanded configuration to a radially compressed configuration with a retraction device.

[0272] 53. The retention device of Example 52, wherein each of the retention members has a protrusion extending radially outward at a distal end of the retention member, each protrusion configured to extend radially outward into an opening in the prosthetic heart valve when the prosthetic heart valve is in the expanded configuration.

[0273] 54. The retention device of Example 52 or Example 53, wherein a distal portion of each retention member extends distally toward the prosthetic heart valve when the prosthetic heart valve is in the expanded configuration, and wherein a distal portion of each retention member is positioned proximal to the prosthetic heart valve when the prosthetic heart valve is in the compressed configuration.

[0274] 55. Any of Examples 52 to 54, further comprising a valve alignment portion configured to secure the retention device to the retraction device, the retention member being movable relative to a distal surface of the valve alignment portion. A holding device according to any one of the preceding claims.

[0275] 56. The retention device of Example 55, wherein a proximal end portion of the prosthetic heart valve abuts a distal surface of the valve alignment portion when the prosthetic heart valve is in the expanded configuration.

[0276] 57. The retention device of example 55 or example 56, further comprising one or more biasing members configured to bias the retention member proximally against the valve alignment portion.

[0277] 58. The retention device of any one of Examples 55 to 57, further comprising one or more arms, the distal end of each arm extending distally relative to the distal surface of the valve alignment portion when the retention member is coupled to the prosthetic heart valve.

[0278] 59. The retention device of Example 58, wherein at least one arm is circumferentially disposed between a pair of adjacent retention members, the retention members extend radially outward relative to the arms when the prosthetic heart valve is in an expanded configuration, and the retention members are compressed radially inward and radially aligned with at least a portion of the arms when the prosthetic heart valve is radially compressed with a contraction device.

[0279] 60. The retention device of example 58 or example 59, wherein the distal end of each arm comprises an inclined surface configured to interface with the retraction device such that, upon actuation of the retraction device, the retraction device exerts a force on the inclined surface, urging the corresponding arm proximally relative to the valve alignment portion.

[0280] 61. A positioning device for positioning a prosthetic heart valve in a delivery device, the positioning device comprising: a body and one or more coupling members mateable with one or more complementary coupling members of a prosthetic heart valve retention device, the body having an inner surface defining an axially extending passage sized to form an interference fit with the shaft of the delivery device.

[0281] 62. The positioning device of example 61, wherein the inner surface of the body comprises an array of circumferentially oriented grooves extending from the proximal end of the body to the distal end of the body such that sterilizing gas can permeate through the plurality of grooves and into the passageway when the body is coupled to the shaft.

[0282] 63. A retention device for a prosthetic heart valve, comprising: a body portion; and one or more retention members, each retention member comprising: a head portion configured to retain the prosthetic heart valve in a radially expanded configuration; and a tail portion coupled to a shelf member of the body portion when the head portion retains the prosthetic heart valve in the radially expanded configuration, the tail portion configured to decouple from the shelf member when the head portion is compressed radially inward such that the prosthetic heart valve can be released from the head portion and collapsed to a radially compressed configuration.

[0283] 64. A retention device for a prosthetic heart valve, comprising: a body portion; and one or more retention members, each retention member comprising a first leg, a second leg, and a biasing member, the second legs configured to retain the prosthetic heart valve in a radially expanded configuration when the first legs engage the body portion to retain the biasing member in the biased configuration, and when the second legs are compressed radially inward to release the prosthetic heart valve from the second legs, the first legs are configured to disengage from the body portion to release the biasing member, thereby returning the retention members to an unbiased configuration that moves them away from the body portion.

[0284] General Considerations Although some operations of the disclosed embodiments are described in a particular sequential order for convenient presentation, it should be understood that the description of this method encompasses rearrangement unless a particular order is required by explicit language set forth herein. For example, operations described as sequential may, in some cases, be rearranged or may be performed simultaneously. Moreover, for simplicity, the accompanying figures may not show the various ways in which the disclosed methods can be used in combination with other methods. Also, the description may use terms such as "provide" or "achieve" to describe the disclosed methods. These terms are high-level abstractions of actual operations that are performed. The actual operations that correspond to these terms may vary depending on the particular implementation and are readily discernible by those skilled in the art when viewed in light of the present description.

[0285] It should be understood that the disclosed embodiments can be adapted to deliver and implant prosthetic devices in any of the heart's native annulus (e.g., pulmonary, mitral, and tricuspid annulus) and can be used with any of a variety of delivery techniques (e.g., retrograde, antegrade, transseptal, transventricular, transatrial, etc.).

[0286] As used herein, the term "proximal" refers to a position, direction, or portion of a device that is closer to the user and further from the implantation site. As used herein, the term "distal" refers to a position, direction, or portion of a device that is further from the user and closer to the implantation site. Thus, for example, proximal movement of a device is movement of the device away from the implantation site and toward the user (e.g., movement out of the patient's body), while distal movement of a device is movement of the device away from the user and toward the implantation site (e.g., movement into the patient's body). The terms "longitudinal" and "axial" refer to axes extending in the proximal and distal directions, unless expressly defined otherwise. Also, when referring to the retention device 110, the positioning device 180, the retraction device 160, the delivery device 50, and the prosthetic valve 10 (when attached to the retention device or delivery device), "proximal" refers to a position, direction, or portion of the device that is closer to the handle of the delivery device and the user, while "distal" refers to a position, direction, or portion of the device that is further from the handle of the delivery device and the user.

[0287] As used herein, the terms "approximately" and "about" refer to the stated value and any value that is within 10% of the stated value. For example, "about 90 degrees" refers to any value between 81 and 99 degrees, inclusive.

[0288] As used in this application and in the claims, the singular forms "a," "an," and "the" include the plural unless the context clearly dictates otherwise. Also, the term "comprises" means "comprising." Furthermore, the terms "coupled" and "coupled" generally mean physically, mechanically, chemically, magnetically, and / or electrically coupled and, unless specifically stated to the contrary, do not exclude the presence of intermediate elements between coupled or coupled items.

[0289] Directions and other relative references (e.g., inside, outside, etc.) may be used herein to facilitate elaboration of the drawings and principles, but are not intended to be limiting. For example, specific terms such as "inside," "outside," "internal," "external," etc. may be used. Such terms, where applicable, are used to provide some clarity of description when dealing with relative relationships, particularly with respect to the illustrated embodiments. However, such terms are not intended to imply absolute relationships, positions, and / or orientations. As used herein, "and / or" means "and" or "or" and "and" and "or."

[0290] In view of the many possible embodiments to which the principles of the present disclosure may be applied, it should be recognized that the illustrated embodiments are merely examples and should not be taken as limiting the scope of the claimed subject matter. Rather, the scope of the claimed subject matter is defined by the following claims and their equivalents.

[0291] [Additional note 1] A holding device; a non-self-expandable prosthetic heart valve that is radially compressible from an expanded configuration to a compressed configuration; Equipped with An assembly, wherein the retention device is configured to hold the prosthetic heart valve in the expanded configuration and is configured to insert the prosthetic heart valve into a crimping device so that the prosthetic heart valve can be crimped in the valve mounting portion of a delivery device. [Additional note 2] 2. The assembly described in Appendix 1, wherein the retention device comprises one or more retention members configured to secure the prosthetic heart valve to the retention device when the prosthetic heart valve is in the expanded configuration and configured to release the prosthetic heart valve from the retention device when the prosthetic heart valve is compressed from the expanded configuration to the compressed configuration in the valve mounting portion of the delivery device. [Additional note 3] 3. The assembly of claim 2, wherein when the prosthetic heart valve is in the expanded configuration, a distal portion of each retention member extends distally toward the prosthetic heart valve, and when the prosthetic heart valve is in the compressed configuration, the distal portion of each retention member is positioned proximal to the prosthetic heart valve. [Additional note 4] 4. The assembly of claim 2 or 3, wherein each of the retention members has a protrusion extending radially outward at a distal end thereof, each protrusion configured to extend radially outward into an opening in the prosthetic heart valve when the prosthetic heart valve is in the expanded configuration. [Additional note 5] 5. The assembly of any one of claims 2 to 4, wherein the retaining device comprises a first portion and a second portion, and one or more of the retention members extend distally from the second portion and are axially movable relative to a distal surface of the first portion. [Additional note 6] 6. The assembly of claim 5, wherein the prosthetic heart valve elongates in one direction when the prosthetic heart valve is contracted from the expanded configuration to the compressed configuration such that the distal surface of the first portion prevents the prosthetic heart valve from elongating proximally while allowing the prosthetic heart valve to elongate distally. [Additional note 7] 7. The assembly of claim 5 or 6, wherein the retention member is configured to extend distally relative to the distal surface of the first part to couple to the prosthetic heart valve in the expanded configuration, and is configured to move proximally relative to the distal surface of the first part after releasing the prosthetic heart valve when the prosthetic heart valve is radially compressed. [Additional note 8] 8. The assembly of claim 7, wherein when the prosthetic heart valve is held by the holding device, a proximal end portion of the prosthetic heart valve abuts the distal surface of the first portion when the prosthetic heart valve is in the expanded configuration and secured to the holding device by the retention member. [Additional note 9] 9. The assembly of any one of claims 5 to 8, wherein the second portion of the retention device comprises one or more inclined protrusions corresponding to one or more of the retention members, each inclined protrusion abutting a corresponding inclined member on the retention member so that the retention member can slide distally into the interior space of the prosthetic heart valve when the prosthetic heart valve is in the expanded configuration. [Additional Note 10] 10. The assembly of any one of clauses 5 to 9, wherein the retaining device comprises one or more biasing members configured to bias the second portion proximally relative to the first portion. [Additional Note 11] 11. The assembly of any one of clauses 5 to 10, wherein the second portion comprises one or more arms, the distal end of each arm extending distally relative to the distal surface of the first portion when the retention member is coupled to the prosthetic heart valve. [Additional Note 12] 12. The assembly described in claim 11, wherein at least one arm is circumferentially disposed between a pair of adjacent retention members, the retention members extending radially outward relative to the arms when the prosthetic heart valve is in the expanded configuration, and the retention members are compressed radially inward when the prosthetic heart valve is radially compressed, thereby aligning radially with at least a portion of the arms. [Additional Note 13] 13. The assembly of claim 11 or 12, wherein the distal end of each arm comprises an inclined surface configured to interface with a retraction jaw such that radially inward movement of the retraction jaw exerts a force on the inclined surface, urging the corresponding arm to move proximally relative to the first portion. [Additional Note 14] 14. The assembly of any one of clauses 1 to 13, further comprising a positioning device configured to be releasably coupled to the shaft of the delivery device and to be releasably coupled to the retention device. [Additional Note 15] 15. The assembly of claim 14, wherein the positioning device comprises a body having an inner surface defining an axially extending passage sized to form an interference fit with a portion of the shaft. [Additional Note 16] 16. The assembly of claim 15, wherein the portion of the shaft is positioned distally at a predetermined distance relative to the valve mounting portion. [Additional Note 17] 17. The assembly of claim 15 or 16, wherein the inner surface of the body comprises an array of circumferentially oriented grooves extending from the proximal end of the body to the distal end of the body such that sterilizing gas can penetrate through the grooves and into the passage when the body is coupled to the shaft. [Additional Note 18] 18. The assembly of any one of clauses 14 to 17, wherein the holding device comprises one or more first coupling members mateable with one or more second coupling members of the positioning device. [Additional Note 19] 19. The assembly of any one of claims 1 to 18, further comprising a retraction device configured to radially compress the prosthetic heart valve from the expanded configuration to the compressed configuration, and wherein the retention device comprises one or more third coupling members mateable with one or more fourth coupling members of the retraction device. [Additional Note 20] 1. A retention device for a prosthetic heart valve, comprising: A retention device comprising one or more retention members configured to secure the prosthetic heart valve to the retention device when the prosthetic heart valve is in a radially expanded configuration and configured to release the prosthetic heart valve from the retention device when the prosthetic heart valve is compressed from the radially expanded configuration to a radially compressed configuration with a contraction device. [Explanation of symbols]

[0292] 10 Prosthetic Heart Valves 12 Stents, frames 14 Valve structure 16 Skirt assembly 18 leaflets 24 Inlet end, inflow end 26 Outlet end, outflow end 28 Posts 30 open cells 35 Interior Space 38 Nodule, apex 38a, 38b nodules 40 Packaging assembly, tool kit 42 Tray 43 Recess 44 Loading device 45 Recess, well 46 Syringe 48 Timer 50 Delivery device, delivery catheter 52 Handle 53 ports 54 Inflatable Balloon 54d Distal end portion 54p proximal end part 56 Maneuverable parts 58 outer shaft 59 Distal end section 60 inner shaft, implantation catheter 62 Valve mounting area, designated placement area 64 Nosecone 65 Distal Shoulder 66 Distal end 67 Proximal Shoulder 68 Proximal end 69 Middle part 70 Mark, shoulder 72 a portion of the outer shaft 58 74 Proximal stop 76 Distal stop 78 Rotatable Knob 80 distal end 100 Mounting assembly 102 Container 104 Container 105 flange 106 Upper opening 107 Hinged Cap 108 pull tab 109 Mooring mechanism 110 Retaining device, valve retainer 112 Center axis 114 Open end 115 Closed End 116 Flange 117 Bump, protrusion 118 Capture Department 119 tabs 120 first portion, valve alignment portion 122 Distal surface 124, 124a, 124b, 124c, 124d aperture 126, 126a, 126c auxiliary opening 126b Third auxiliary opening 128 recess 130 Main Unit 132 vacant spaces 134 Outer periphery 136 Interior Space 138 biasing member 140 Second part, valve retaining part 142 Reserved Materials 142a, 142c valve retaining members 142b valve retaining member, third retaining member 144 Protrusion 144b Foundation part 144h Head part 144s proximal inclined surface 144t tip part 144v Proximal vertical plane, proximal plane 145 Cantilever beam 146 Arm 146a, 146b, 146c, 146d Extended arms 147 Slope 147i inner part 147o outer part 148 Piston member 150 Proximal Plate 152 vacant spaces 154 Outer periphery 160 Shrinking device 164 Open end 165 Closed End 166 Proximal surface, anterior surface 168 Capture Department 170 Retracted Jaw 171 Central axis 172 Windows and openings 174 Shrinkage opening 176 cabinet 177 Levers, handles 178 frames 180 Positioning Device 181 Main Unit 182 First Part 183 Fastening mechanism, latching mechanism 183a, 183b protrusion 184 Second Part 185 Inside 186 Hinge member 188 Central passage, lumen 190 proximal end 191 Mizoji 192 distal end 194 Groove 196 flange 198 tabs 210 Holding device 238 biasing member 248 Piston member 260 Inclined protrusion 262 Slanted inner surface 264 Inclined protrusion 266 Slanted outer surface 310 Holding device 316 flange 320 Valve alignment part 322 Distal surface 324 Aperture 326 Inner Panel 330 Main body part 332 vacant spaces 334 Outer periphery 336 Shelf parts 338 Groove 339 Ridge part 340 Valve retaining member 342 Head part 344 Main body part 345 Hinge 346 Tail part 410 Holding device 416 Flange 420 Valve alignment part 422 Distal surface 424 Aperture 430 Main body part 432 vacant spaces 434 Outer periphery 440 Valve retaining member 442 Basic part 444 First Leg 446 Second Leg 447 Distal end section 448 Shelf 450 proximal part 452 distal portion 454 Tip part 456 Notch, Hook 458 biasing member D. Axial distance between the landmark 70 and the proximal end 68 of the valve mounting portion 62 D1 Diameter of body 130 D2 Diameter of proximal plate 150 D C Diameter of the prosthetic heart valve 10 in a compressed configuration D E Diameter of the prosthetic heart valve 10 in the expanded configuration L Axial length of the valve mounting portion 62 W1 Inner width of gap 132 W1' outer width of the cavity 132 W2 Inner width of gap 152 W2' outer width of cavity 152 W D Longitudinal dimension of protrusion 144

Claims

1. A holding device; a prosthetic heart valve that is radially compressible from an expanded configuration to a compressed configuration; Equipped with the retention device is configured to retain the prosthetic heart valve in the expanded configuration and to insert the prosthetic heart valve into a crimping device so as to crimp the prosthetic heart valve in the valve mounting portion of the delivery device; the retention device is configured to release the prosthetic heart valve from the retention device when the prosthetic heart valve is compressed from the expanded configuration to the compressed configuration in the valve mounting portion of the delivery device; the retaining device has a first portion and a second portion; the second portion is axially movable relative to the prosthetic heart valve when the prosthetic heart valve is compressed from the expanded configuration to the compressed configuration in the valve mounting portion of the delivery device; the second portion comprises at least one inclined surface; an inclined surface of the at least one second portion configured to move axially relative to the prosthetic heart valve when the prosthetic heart valve is compressed from the expanded configuration to the compressed configuration in the valve mounting portion of the delivery device;

2. 2. The assembly of claim 1, wherein at least one of the ramp surfaces is configured to interface with a retraction jaw, such that radially inward movement of the retraction jaw exerts a force on the at least one ramp surface, urging the at least one ramp surface to move axially relative to the prosthetic heart valve.

3. An assembly as described in claim 1 or 2, wherein when the retraction device is activated, the retention device is configured to release the prosthetic heart valve from the retention device.

4. The assembly of claim 1 , wherein a distal surface of the first portion comprises one or more recesses.

5. 5. The assembly of claim 4, wherein the prosthetic heart valve elongates in one direction when the prosthetic heart valve is contracted from the expanded configuration to the compressed configuration, whereby the prosthetic heart valve elongates distally while the distal surface prevents the prosthetic heart valve from elongating proximally.

6. 6. The assembly of claim 1, wherein the second portion comprises one or more retention members configured to secure the prosthetic heart valve to the retention device when the prosthetic heart valve is in the expanded configuration and configured to release the prosthetic heart valve from the retention device when the prosthetic heart valve is compressed from the expanded configuration to the compressed configuration in the valve mounting portion of the delivery device.

7. The retraction device configured to radially compress the prosthetic heart valve from the expanded configuration to the compressed configuration; a retention device configured to retain the prosthetic heart valve for contraction by the contraction device; Equipped with the retaining device comprises one or more first coupling members mateable with one or more second coupling members of the retracting device; 7. The assembly of claim 1, wherein the one or more first coupling members and the one or more second coupling members are configured to rotationally lock the retaining device relative to the shortening device so as to be able to shorten the prosthetic heart valve in a predetermined rotational position relative to the delivery device at the valve mounting portion of the delivery device.

8. The assembly of claim 7 , wherein at least one of the ramped surfaces is configured to move axially relative to the retraction device when a retraction jaw of the retraction device contacts the at least one ramped surface.

9. one or more of the first coupling members includes one or more tabs; 9. The assembly of claim 7 or 8, wherein one or more of the second coupling members comprises one or more catches.

10. The assembly of claim 1 , further comprising a positioning device configured to be releasably coupled to a shaft of the delivery device.

11. The assembly of claim 10 , wherein the positioning device comprises a body having an inner surface defining an axially extending passage sized to form an interference fit with a portion of the shaft.

12. 12. The assembly of claim 10 or 11, wherein the retaining device comprises one or more third coupling members mateable with one or more fourth coupling members of the positioning device.

13. The retraction device configured to radially compress the prosthetic heart valve from the expanded configuration to the compressed configuration; a retaining device configured to hold the prosthetic heart valve in the expanded configuration and configured to insert the prosthetic heart valve into the crimping device so that the prosthetic heart valve can be crimped at the valve mounting portion of the delivery device; a positioning device configured to be releasably coupled to a shaft of the delivery device; Equipped with 13. The assembly of claim 1, wherein the retaining device and the positioning device are configured to be matable with a first side of the retracting device.

14. 14. An assembly according to any one of claims 1 to 13, wherein the retaining device comprises one or more first coupling members mateable with one or more second coupling members of the retracting device.

15. one or more of the first coupling members includes one or more tabs; The assembly of claim 14 , wherein one or more of the second coupling members comprises one or more catches.

16. 15. The assembly of claim 1, wherein the retaining device comprises one or more third coupling members mateable with one or more fourth coupling members of the positioning device.

17. 1. A retention device for a prosthetic heart valve, comprising: one or more coupling members configured to mate the retention device with a retraction device; at least one inclined surface of the retaining device configured to move axially relative to the retracting device upon actuation of the retracting device; Equipped with The retention device is configured to retain the prosthetic heart valve in the retention device when the prosthetic heart valve is in a radially expanded configuration, and to release the prosthetic heart valve from the retention device when the prosthetic heart valve is compressed from the radially expanded configuration to a radially compressed configuration by actuation of a contraction device.

Images