Prosthetic heart valve extension device

Abstract

An extension device for collapsing a prosthetic heart valve device comprises a shaft comprising first and second ends opposite each other, a support body axially aligned with and configured to provide support for the shaft, an actuation mechanism connected to the support body and configured to provide axial movement to the shaft, a grasping mechanism connected to the support body that is configured to releasably capture a first portion of a prosthetic heart valve device and a capturing mechanism connected to the shaft that is configured to releasably capture a second portion of the prosthetic heart valve device, wherein the shaft is configured to move from a first retracted state whereby the prosthetic heart valve device can be radially un-collapsed when attached to the extension device, to a second extended state whereby the prosthetic heart valve device can be radially collapsed when attached to the extension device.

Description

PROSTHETIC HEART VALVE EXTENSION DEVICE

[0001] This application claims the benefit of priority to U.S. Provisional Patent Application Serial No. 63 / 643,547, filed May 7, 2024, which is incorporated herein by reference in its entirety.TECHNICAL FIELD

[0002] The present disclosure, including the technology described herein, relates generally to prosthetic heart valve devices for repairing and / or replacing native heart valves. More particularly, the present disclosure relates to peripheral devices used to prepare a prosthetic heart valve, such as atrioventricular valves, for delivery into a beating human heart, for the purpose of restoring valve function to a diseased, damaged, or malfunctioning valve, such as native mitral and tricuspid valves. Even more particularly, the present disclosure relates to periphery devices used to prepare prostheses for implantation within a lumen or body cavity with delivery systems for the prosthesis.BACKGROUND

[0003] Atrioventricular valve insufficiency, also known as mitral and / or tricuspid valve regurgitation or incompetence, is a heart condition in which the atrioventricular valve (mitral and / or tricuspid) does not close properly. Both the mitral and tricuspid apparati of a healthy human heart are comprised of fibrous and muscular annulus tissue; attached to this are flexible resilient leaflets that close upon ventricular contraction. The free ends of each of the flexible leaflets are attached to chordae tendineae which tether the leaflets to papillary muscles within the ventricle, controlling the motion of the leaflet free ends throughout the cardiac cycle. All of these components of the apparati must function in synchrony for proper systemic blood circulation. Various cardiac diseases or degenerative conditions can impact any of the components of an atrioventricular valve, resulting in improper closure of the valve. This results in abnormalleakage of blood flow through the valve into the atrium and peripheral vasculature. Persistent atrioventricular valve regurgitation can result in a myriad of cardiovascular complications, including congestive heart failure.

[0004] Traditionally, patients suffering from mitral regurgitation have received treatment through open-heart surgery, involving either surgical repair of the native valve or surgical replacement of the valve altogether. Generally, these procedures result in good clinical outcomes, however the invasiveness and lengthy recovery periods associated with open-heart surgery preclude a large percentage of potential patients. Consequently, many patients are left untreated and are managed under medical therapy. Patients suffering from tricuspid regurgitation are treated to an even lesser extent through surgical procedures, therefore an even greater population of medically managed patients suffering from tricuspid regurgitation exist. Patients managed under medical therapy for atrioventricular valve disease can have poor quality of life and unfavorable longterm outcomes; many experiencing a five-year mortality rate of 50% or greater.

[0005] Significant advancements in the development of minimally invasive transcatheter valve therapies have been made over the years, with the greatest advancements made in treating aortic and pulmonary valve disease. An exemplary prosthesis includes that which is described in U.S. Patent No.7,892,281 to Seguin et al.; the entire contents of which are incorporated herein by reference in their entirety for all purposes. Some advancement has been made in treating mitral valve insufficiency through transcatheter therapies. An exemplary prosthesis includes that which is described in U.S. Patent No. 8,652,203 to Quadri et al.; the entire contents of which are incorporated herein by reference in their entirety for all purposes. An additional exemplary prosthesis includes that which is described in U.S. Patent No. 9,034,032 to McLean et al.; the entire contents of which are incorporated herein by reference in their entirety for all purposes. Despite the technological advances in the field, a large population of potential patients remains unsuitable for such therapies and remains either untreated, or subject to unfavorable outcomes due to the limitations of the current technologies. Limitations and outcomes include, but are not limited to, the potential for outflow tract obstruction, thrombus formation and thromboembolic events due to atrial flow stasis and prolonged procedures resulting in adverse events and / or exposed radiation to the patients and surgicalstaff. The present state of the art has offered little advancement toward the treatment of tricuspid valve insufficiency through transcatheter valve replacement therapies. Given the limitations of the current technologies and the large population of untreated patients, there remains a need for improved devices, systems and methods with greater ease, accuracy, and repeatability for treating atrioventricular valve insufficiency.OVERVIEW

[0006] The present inventors have recognized, among other things, that problems to be solved in prosthetic heart valve devices is the difficulty in preparing the prosthetic heart valve device for delivery to the heart loaded onto a delivery catheter. For example, typical heart valve prostheses comprise frame structures that can displace the native heart valve tissue to allow prosthetic valve material to be placed in the native annulus. As such, the frame structures typically have some rigidity when deployed. When deployed, the frame structures are expanded to the size of the native annulus. In the deployed state, the frame structures are many times larger than vasculature connecting to the heart. As such, it becomes advantageous to compress the frame structure into a collapsed state for delivery into the heart through the vasculature. For example, many frame structures are formed from laser cut tubes, wire mesh or wire connected in a diamond-shape pattern that can be expanded from a tubular-like state to a larger annulus. The heart valve prostheses are attached to delivery catheters in the collapsed state for guiding through the vasculature. The heart valve prostheses can be configured to expand, sometimes by spring-like selfexpansion, when released from the deliver catheter upon being delivered to the appropriate location in the heart. Thus, to prepare the heart valve prostheses for delivery, they are typically compressed, retained in the compressed state, and attached to the delivery catheter in the compressed state. Such processes can be difficult for heart valve prosthesis that are small in size and fabricated from pliable metal wire structures.

[0007] The present subject matter can help provide solutions to these problems and other problems, such as by providing peripheral devices and systems that can be used to load a prosthetic device onto a delivery system. In examples, the present disclosure describes, but is not limited to, devices andsystems that can be used for preparing a replacement prosthetic heart valve device for replacement of a deficient atrioventricular valve, more specifically a deficient native tricuspid and / or mitral valve in the heart of a human patient. The present disclosure includes stretching devices that can collapse radially expandable frames into a radially smaller and axially longer shape for loading onto a delivery system, e.g., a delivery catheter. The stretching devices can attach to attachment features of end portions of a frame structure of a prosthetic valve while the prosthetic valve is in a radially expanded state. The stretching devices can apply mechanical force to the frame structure to collapse the frame structure. For example, the stretching device can include an actuation force that can utilize a mechanical advantage, such as a threaded coupling, a lever, a cam or a biasing, e.g., spring, force. As such, a user or operator need not have to manually hold and collapse the frame structure while loading the frame structure onto a delivery system.

[0008] In an example, an extension device for radially collapsing a prosthetic heart valve device comprises a shaft comprising first and second ends opposite each other, a support body axially aligned with and configured to provide support for the shaft, an actuation mechanism connected to the support body and configured to provide axial movement to the shaft, a grasping mechanism connected to the support body that is configured to releasably capture a first portion of a prosthetic heart valve device and a capturing mechanism connected to the shaft that is configured to releasably capture a second portion of the prosthetic heart valve device, wherein the shaft is configured to move from a first retracted state whereby the prosthetic heart valve device can be radially uncollapsed when attached to the extension device, to a second extended state whereby the prosthetic heart valve device can be radially collapsed when attached to the extension device.

[0009] In another example, a method of collapsing a radially expandable prosthetic heart valve device to a radially compressed state can comprise loading the radially expandable prosthetic heart valve device onto a shaft of a stretching device, attaching a first end portion of the radially expandable prosthetic heart valve device to a capture mechanism on the shaft, attaching a second end portion of the radially expandable prosthetic heart valve device to a support structure for the shaft and operating a stretching mechanism of the stretching device toradially collapsed and axially extend the radially expandable prosthetic heart valve device.

[0010] This overview is intended to provide an overview of subject matter of the present patent application. It is not intended to provide an exclusive or exhaustive explanation of the invention. The detailed description is included to provide further information about the present patent application.BRIEF DESCRIPTION OF THE DRAWINGS

[0011] FIG. l is a perspective front view of a stretching device of the present disclosure that can be configured to collapse a prosthetic valve device for loading onto a delivery catheter.

[0012] FIG. 2 is a perspective rear view of the stretching device of FIG. 1.

[0013] FIG. 3 is a top view of the stretching device of FIG. 1 and FIG. 2 shown relative to a prosthetic valve device in an expanded state.

[0014] FIG. 4 is an exploded view of the stretching device of FIG. 1 through FIG. 3 showing a base, a main barrel, a mandrel, an actuator, a shaft, frame holders, a gripping handle and a rotating hub.

[0015] FIG. 5 is a cross-sectional view of the stretching device of FIG. 3 taken at section 5-5 showing assembly of the actuator, the shaft, the frame holders, the gripping handle and the rotating hub.

[0016] FIG. 6 is a close-up cross-sectional view of the actuator of FIG. 5 comprising a handwheel and spindle.

[0017] FIG. 7 is an exploded view of the actuator showing the handwheel, the spindle and a connector.

[0018] FIG. 8 is a close-up cross-sectional view of the frame holder assembly of FIG. 5 comprising a plurality of frame holders having hooks.

[0019] FIG. 9 is a perspective view of the frame holder assembly shown with the mandrel removed to show three frame holders.

[0020] FIG. 10 is a perspective view of a frame holder connected to a rotation pin.

[0021] FIG. 11 is a close-up cross-sectional view of a rotating hub of a capture mechanism of FIG. 5 showing a connection peg for connecting to a prosthetic valve device.

[0022] FIG. 12 is a perspective cross-sectional view of the mandrel with the rotating hub removed to show a plurality of connection pegs for the prosthetic valve device.

[0023] FIG. 13 A is a side view of a prosthetic valve device in an expanded stated positioned around the mandrel of the stretching device of the present disclosure.

[0024] FIG. 13B is a side view of the stretching device of FIG. 13 A showing a first end of the prosthetic valve device moved radially closer to the mandrel and the rotating hub.

[0025] FIG. 13C is a side view the stretching device of FIG. 13B with the rotating hub rotated to expose a connection peg for the prosthetic valve device.

[0026] FIG. 13D is a side view of the stretching device of FIG. 13C with an attachment feature of the prosthetic valve device attached to the connection peg.

[0027] FIG. 13E is a side view of the stretching device of FIG. 13D showing a second end of the prosthetic valve device connected to the frame holder assembly.

[0028] FIG. 13F is a side view of the stretching device of FIG. 13E showing the prosthetic valve device fully loaded into the stretching device ready to be stretched.

[0029] FIG. 14A and FIG. 14B are a perspective views of a cone device of the present disclosure that can be used with the stretching devices of the present disclosure to facilitate collapsing and stretching of prosthetic valves and to retain the prosthetic valves in a collapsed and stretched state.

[0030] FIG. 15 is side view of the prosthetic valve and stretching device of FIG. 13F with the cone device of FIG. 14A and FIG. 14B positioned over the prosthetic valve.

[0031] FIG. 16 is a perspective view of a sleeve device of the present disclosure that can be used with the stretching devices of the present disclosure to facilitate collapsing and stretching of prosthetic valves and to retain the prosthetic valves in a collapsed and stretched state.

[0032] FIG. 17 is a perspective view of a prosthetic valve device of the present disclosure loaded into a sleeve device in a collapsed and stretched state detached from a stretching device.

[0033] FIG. 18A is a side view of a prosthetic valve device of the presentdisclosure being released from a stretching device while positioned within a sleeve device.

[0034] FIG. 18B is a side view of the prosthetic valve device and the sleeve device of FIG. 18A separated from the stretching device.

[0035] FIG. 19A is a perspective view of a stretching device of the present disclosure in an extended state, wherein the stretching device includes a spring- loaded, cam-actuated stretching mechanism.

[0036] FIG. 19B is a perspective view of the stretching device of FIG. 19A in a retracted state.

[0037] FIG. 20 is a top view of the stretching device of FIG. 19A and FIG. 19B in and extended state.

[0038] FIG. 21 is a side-cross sectional view of the stretching device of FIG. 20 showing a cam mechanism and a biasing spring.

[0039] FIG. 22A is a perspective view of a stretching device of the present disclosure in an extended state, wherein the stretching device includes boltaction actuation mechanism.

[0040] FIG. 22B is a perspective view of the stretching device of FIG. 22A in a retracted state.

[0041] FIG. 23 A illustrates an exemplary delivery system, with an exemplary loading tool in connected fashion, and an exemplary prosthetic heart valve device compressed within an exemplary cylindrical retaining sleeve for transfer into the delivery system, in accordance with some applications of the invention.

[0042] FIG. 23B illustrates the delivery system of FIG. 23 A having an open catheter, with the loading tool in connected fashion, and the prosthetic heart valve device compressed within the cylindrical retaining sleeve for transfer into the delivery system.

[0043] FIG. 23 C illustrates an enlarged view of a detail section of a connection feature of the delivery system of FIG. 23B.

[0044] FIG. 23D illustrates the delivery system of FIG. 23B having an open catheter, with the loading tool in connected fashion, and the prosthetic heart valve device compressed within the cylindrical retaining sleeve in position for connection to the delivery system.

[0045] FIG. 23E illustrates an additional view of the subject matter of FIG. 23D, detailing exemplary connection elements of the delivery system.

[0046] FIG. 23F illustrates the delivery system of FIG. 23D having an open catheter, with the loading tool in connected fashion, and the prosthetic heart valve device compressed within the cylindrical retaining sleeve and having connection elements compressed in position for connection to the delivery system.

[0047] FIG. 23 G illustrates an enlarged view of a detail section of the attachment feature of the prosthetic heart valve device of FIG. 23F on an exemplary retaining peg connection feature of the exemplary delivery system.

[0048] FIG. 23H illustrates an enlarged view of a detail section of the attachment feature of the prosthetic heart valve device of FIG. 23F captured beneath a catheter leading edge of the delivery system.

[0049] FIG. 231 illustrates the delivery system of FIG. 23F, with the loading tool in position to radially compress the prosthetic heart valve device.

[0050] FIG. 23 J illustrates the delivery system of FIG. 231, with the catheter leading edge further radially compressing and capturing the prosthetic heart valve device.

[0051] FIG. 23K illustrates the delivery system of FIG. 23 J, with the prosthetic heart valve device fully captured within a catheter.

[0052] FIG. 24 is a block diagram illustrating operations in methods of loading a radially expanded prosthetic valve device into a stretcher device.

[0053] In the drawings, which are not necessarily drawn to scale, like numerals may describe similar components in different views. Like numerals having different letter suffixes may represent different instances of similar components. The drawings illustrate generally, by way of example, but not by way of limitation, various embodiments discussed in the present document.DETAILED DESCRIPTION

[0054] The present specification and drawings provide aspects and features of the disclosure in the context of several embodiments of peripheral devices and systems used in the preparation of replacement prosthetic heart valve devices that are configured for use in the vasculature of a patient, such as for replacement of native heart valves in a patient. These embodiments may bediscussed in connection with replacing specific valves such as mitral or tricuspid valves of the patient. However, it is to be understood that the features and concepts discussed herein can be applied to products other than prosthetic heart valve devices. For example, the peripheral devices of the present disclosure can be used in conjunction with other types of medical implants, for example other types of expandable prosthesis, such as stents, for use elsewhere in the body, such as within an artery, a vein, or other body cavities or locations. In addition, particular features of peripheral devices, systems, or methods used in the preparation of replacement prosthetic heart valve devices should not be taken as limiting, and features of any one example or embodiment discussed herein may be combined with features of other examples or embodiments as desired and when appropriate. While certain of the embodiments described herein are described in connection with a specific delivery approach, such as transfemoral, it should be understood that these embodiments may be used for other delivery approaches, such as trans-atrial or transapical. Moreover, it should be understood that certain of the features described in connection with some examples and embodiments can be incorporated with other examples and embodiments, including those which are described in connection with different delivery approaches, e.g., transfemoral, trans-atrial or transapical.

[0055] FIG. 1 is a perspective front view of stretching device 10 of the present disclosure that can be configured to collapse prosthetic valve device 70 (FIG. 3) for loading onto a catheter of delivery system 7000 (FIG. 23 A). FIG. 2 is a perspective rear view of stretching device 10 of FIG. 1. FIG. 1 and FIG. 2 are discussed concurrently.

[0056] Stretching device 10 can comprise base 12, main barrel 14, mandrel 16, actuator 18, shaft 20, frame holder assembly 22, gripping handle 24 and rotating hub 26. Stretching device 10 can also be referred to an extension device.

[0057] Base 12 can comprise pedestal 30, clasping arm 32A and clasping arm 32B.

[0058] Main barrel 14 can comprise distal portion 34, attachment portion 36, flange 38 A, flange 38B and proximal portion 40.

[0059] Mandrel 16 can comprise shaping portion 42, tapered portion 43, shaft portion 44 and coupling portion 45.

[0060] Actuator 18 can comprise handwheel 46 and spindle 48.

[0061] Shaft 20 can comprise threaded portion 50, pin hole 51 (FIG. 4) and insertion portion 52 (FIG. 4).

[0062] Frame holder assembly 22 can comprise frame holder 54A, frame holder 54B and frame holder 54C (FIG. 2).

[0063] Gripping handle 24 can comprise grip body 56.

[0064] Rotating hub 26 can comprise clasp portion 58, cut-out 60 and grip portion 62.

[0065] As discussed herein, ends or end portions of prosthetic valve device 70 (FIG. 3) can be attached to frame holder assembly 22 and rotating hub 26 in an expanded state. Thereafter, actuator 18 can be operated to move shaft 20 distally through main barrel 14 to move rotating hub 26 away from frame holder assembly 22, thereby stretching and collapsing prosthetic valve device 70 (FIG. 3). The stretched and collapsed prosthetic valve device can be retained in the stretched and collapsed state using a retaining cone or retaining sleeve 300 of FIG. 14A and FIG. 14B or cylindrical retaining sleeve 400 of FIG 16. The stretched and collapsed prosthetic valve device can then be attached to delivery system 7000 of FIG. 23 A to FIG. 23K for delivery into anatomy of a patient, such as a heart.

[0066] FIG. 3 is a top view of stretching device 10 of FIG. 1 and FIG. 2 shown relative to prosthetic valve device 70. In FIG. 3, prosthetic valve device 70 is shown in an expanded state, and stretching device 10 is shown in a contracted state. Prosthetic valve device 70 is shown in a state in which it is to be deployed within a heart. Loading of prosthetic valve device 70 into stretching device 10 and thereafter stretching and collapsing prosthetic valve device 70 is described below with reference to FIG. 13A to FIG. 13F.

[0067] FIG. 4 is an exploded view of stretching device 10 of FIG. 1 through FIG. 3 showing base 12, main barrel 14, mandrel 16, actuator 18, shaft 20, frame holder assembly 22, gripping handle 24 and rotating hub 26. Stretching device 10 can additionally include peg 80A, peg 80B, peg 80C, pin 82A, pin 82B, pin 82C, spring 84, pin 86, pin 88 and clamp 90. FIG. 5 is a cross-sectional view of stretching device 10 of FIG. 3 taken at section 5-5 showing assembly of actuator 18, shaft 20, frame holder assembly 22, gripping handle 24 and rotating hub 26. FIG. 4 and FIG. 5 are discussed concurrently.

[0068] Base 12 can comprise pedestal 30 to which clasping arm 32A and clasping arm 32B are connected. For example, clasping arm 32A and clasping arm 32B can be joined by plate 92, which can be fastened or joined to a mating surface of pedestal 30. In examples, one or more of bolts, screws and welding can be used to join plate 92 and pedestal 30. In additional examples, clasping arm 32A and clasping arm 32B can be integral or monolithic with pedestal 30. Base 12 can comprise a wide footprint for which main barrel can be supported. Base 12 can be weighted to provide stability to stretching device 10. Thus, base 12 can support main barrel 14 so that actuator 18 can be operated without risk or with reduced risk of stretching device 10 becoming unstable and falling over or tipping over. In examples, base 12 can comprise a hollow shell having a wide bottom portion that curves or necks downward into a narrower top portion to connect with plate 92, as can be seen in FIG. 5. In examples, base 12 can comprise a base plate connected to an extension plate that can join to plate 92 or directly to main barrel 14, similar to what is shown in FIG. 19A and FIG. 19B. In examples, base 12 can be fabricated from metal, such as stainless steel or aluminum, or plastic or polymer materials.

[0069] Main barrel 14 can be assembled with base 12 via clasping arm 32A and clasping arm 32B. Clasping arm 32A and clasping arm 32B can comprise curved arms shaped to engage flush with attachment portion 36. However, clasping arm 32A and clasping arm 32B need not fully engage flush with attachment portion 36. In examples, clasping arm 32A and clasping arm 32B can be configured to flex to accommodate main barrel 14. However, clasping arm 32A and clasping arm 32B can be ridged. Flange 38A and flange 38B can be positioned on main barrel 14 to demark a location for clasping arm 32A and clasping arm 32B. Flange 38A and flange 38B can be spaced apart a distance that allows clasping arm 32A and clasping arm 32B to fit therebetween. In examples, the distance between opposing faces of flange 38A and flange 38B can be approximately equal to the length of clasping arm 32A and clasping arm 32B, thereby preventing main barrel 14 from moving axially relative to base 12. Flange 38A and flange 38B can be integral with main barrel 14 or can be attached thereto, such as via welding. In additional examples, main barrel 14 can comprise a depression or groove, alternative to or in conjunction withclasping arm 32A and clasping arm 32B, into which clasping arm 32A and clasping arm 32B can fit.

[0070] Main barrel 14 can comprise a generally cylindrical body having central bore 94 through with shaft 20 extends. Central bore 94 can extend through distal portion 34, attachment portion 36 and proximal portion 40. In the illustrated example, central bore 94 can comprise a threaded bore configured to engage with threaded portion 50 of shaft 20. In additional examples, central bore 94 can comprise a simple through-bore, a smooth bore, or an unthreaded bore and shaft 20 can comprise a smooth shaft or unthreaded shaft that can slide freely within central bore 94, similar to what is shown in FIG. 21. Main barrel 14 is shown as a single, monolithic component, but can be fabricated from multiple components assembled or joined together.

[0071] Distal portion 34 of main barrel 14 can include cutouts for receiving frame holder assembly 22. Specifically, as can be seen in FIG. 9, distal portion 34 can include cutout 98A, cutout 98B and cutout 98C for receiving frame holder 54A, frame holder 54B and frame holder 54C, respectively. As discussed in greater detail with reference to FIG. 8 and FIG. 9, main barrel 14 can include pin holes for receiving pin 82A, pin 82B and pin 82C (FIG. 4) to hold frame holder 54A, frame holder 54B and frame holder 54C in assembly with main barrel 14. In particular, pin 82A, pin 82B and pin 82C can rotatably connect frame holder 54A, frame holder 54B and frame holder 54C to main barrel 14.

[0072] Proximal portion 40 can be configured, e.g., shaped and sized, to facilitate joining with and operation of actuator 18, as discussed in greater detail with reference to FIG. 6 and FIG. 7. For example, proximal portion 40 can be tapered or curved to allow for operation of actuator 18. For example, tapering or curving of proximal portion 40 can provide clearance to avoid interfering with hands of a user or operator that is utilizing actuator 18.

[0073] Actuator 18 can be connected to a proximal end portion of shaft 20 and can be used to provide input to shaft 20 to move rotating hub 26 relative to frame holder assembly 22. In the illustrated example, actuator 18 can be configured to provide rotation to shaft 20 along axis AA. As discussed in greater detail with reference to FIG. 6 and FIG. 7, actuator 18 can comprise a handwheel for rotating shaft 20. However, actuator 18 can be configured to have other operating mechanisms that provide mechanical advantage, such as a spring-loaded and camming mechanism, as shown in FIG. 19A to FIG. 21.Additionally, actuator 18 can be configured to have a bolt-action type of mechanism, as shown in FIG. 22 A and FIG. 22B.

[0074] Mandrel 16 can be connected to the distal end of shaft 20 extending from distal portion 34 of main barrel 14. In examples, mandrel 16 can be connected to shaft 20 in a rotatable manner such that mandrel 16 can rotate relative to shaft 20. In particular, mandrel 16 can include socket 96 into which insertion portion 52 of shaft 20 can be inserted. Thus, insertion portion 52 of shaft 20 can rotate within socket 96 when rotated by actuator 18 and a user holds -gripping handle 24. As discussed herein, mandrel 16 can remain stationary or approximately stationary relative to rotation about axis AA via engagement with prosthetic valve device 70, as shown in FIG. 13E.

[0075] Shaping portion 42 (FIG. 4) of mandrel 16 can be positioned proximate to frame holder assembly 22 (FIG. 3) such that a first portion of prosthetic valve device 70, such as an atrial end, can be positioned to lay across shaping portion 42 and extend toward coupling portion 45. Shaping portion 42 (FIG. 4) of mandrel 16 can be positioned proximate to coupling portion 45 of mandrel 16 such that a second portion of prosthetic valve device 70, such as a ventricular end, can be positioned to lay across shaping portion 42 and extend toward frame holder assembly 22 (FIG. 3) As discussed in greater detail with reference to FIG. 11 and FIG. 12, coupling portion 45 can work in conjunction with rotating hub 26 to connect to a second portion of prosthetic valve device 70, such as a ventricular end.

[0076] Shaping portion 42 can be positioned between frame holder assembly 22 and rotating hub 26 to engage with prosthetic valve device 70. Shaping portion 42 of mandrel 16 can be used to influence the shape of prosthetic valve device 70 when stretching device 10 is operated to axially extend and radially compress prosthetic valve device 70. For example, shaping portion 42 can include a radially outer surface that has a larger diameter than shaft portion 44. Tapered portion 43 can connect shaping portion 42 with shaft portion 44. Prosthetic valve device 70 can collapse down around shaping portion 42 of mandrel 16. Mandrel 16 can be configured to provide a non-rotating surface that can control the drawdown of prosthetic valve device 70. That is, shaft 20 can rotate within mandrel 16 as mandrel 16 is being held in place by prosthetic valvedevice 70 and / or a user holding onto gripping handle 24. Mandrel 16 can be shaped to control the shape of prosthetic valve device 70, particularly the end of prosthetic valve device 70 proximate to rotating hub 26. Mandrel 16 can prevent unexpected movement of the frame of prosthetic valve device 70, such as infolding where portions of the prosthetic heart valve device become bowed inward. The diameter of mandrel 16 can be designed to support prosthetic valve device 70 and stop further radial drawdown, and additionally to provide an axial conduit or lumen in prosthetic valve device 70 so that upon removal from stretching device 10 and in preparation for loading into delivery system 7000 (FIG. 23 A), elements of delivery system 7000 can be easily passed through this central lumen. As such, mandrel 16 can be bowed radially outward relative to shaft portion 44 to maintain radial or circumferential symmetry of prosthetic valve device 70 during the stretching procedure and form the central lumen. In examples, the radially outer surface of shaping portion 42 of mandrel 16 can be cylindrical, e.g., axially extending parallel to axis AA. However, the radially outer surface of shaping portion 42 can have other shapes such as being tapered in the distal or proximal directions, curved inward or curved outward, bowed inward or bowed outward, and the like.

[0077] Rotating hub 26 can be attached to shaft portion 44 of mandrel 16. Rotating hub 26 can be allowed to rotate about shaft portion 44 and to translate axially along shaft portion 44. Spring 84 can be positioned around shaft portion 44 to bias rotating hub 26 toward shaping portion 42 of mandrel 16. Rotating hub 26 can be positioned axially between peg 80A, peg 80B and peg 80C and gripping handle 24. One or more of cut-out 60 (FIG. 3) on clasp portion 58 can be configured to engage or align with peg 80A, peg 80B and peg 80C and grip portion 62 can receive spring 84 within pocket 99. As discussed in greater detail with reference to FIG. 11 and FIG. 12, rotating hub 26 can cooperate with peg 80A, peg 80B and peg 80C to couple prosthetic valve device 70 to stretching device 10.

[0078] Gripping handle 24 can be positioned at the distal end of shaft portion 44 of mandrel 16. Grip body 56 can include internal bore 100 into which shaft portion 44 can be inserted. Grip body 56 be connected to shaft portion 44 by pin 86. Grip body 56 can form a stop for spring 84. That is, spring 84 can push against grip body 56 to provide biasing force against rotating hub 26. Grippinghandle 24 can provide a portion of stretching device 10 upon which a user or operator can grasp to operate stretching device 10 and to additionally hold mandrel 16 steady, such as by preventing mandrel 16 from rotating, while shaft 20 is rotated via actuator 18.

[0079] FIG. 6 is a close-up cross-sectional view of actuator 18 of FIG. 5 comprising handwheel 46, spindle 48 and pin 88. FIG. 7 is an exploded view of actuator 18 showing handwheel 46, spindle 48 and pin 88. Handwheel 46 can comprise handwheel body 110 comprising hub 116, socket 118, wheel 120, spokes 122, receptacle 124 and pin hole 126. Spindle 48 can comprise spindle body 112 comprising handle portion 128 and rotation portion 130. FIG. 6 and FIG. 7 are discussed concurrently.

[0080] Shaft 20 can be inserted into socket 118 on hub 116. Hub 116 can include pin hole 126 that can align with pin hole 51 on threaded portion 50 of shaft 20. Pin 88 can be inserted into pin hole 126 and pin hole 51. Pin 88 can comprise a pin, such as a coil pin or spring pin that can apply force against pin hole 126 and pin hole 51 when inserted therein to prevent displacement of pin 88. Spokes 122 can extend from hub 116 to wheel 120. Wheel 120 can comprise a circular hoop that an operator can grasp to apply rotational force to actuator 18. Spindle body 112 can be connected to wheel 120 to provide another grasping means for a user or operation. Rotation portion 130 of spindle body 112 can be inserted into receptacle 124 and can be retained therein via a snap-fit connection or the like. The end of rotation portion 130 opposite handle portion 128 can include one or more flanges to prevent axial displacement of spindle 48. Thus, rotation portion 130 can include cut-outs to allow portions of rotation portion 130 to deflect radially inward to allow the flanges to pass through receptacle 124. Rotation portion 130 can be configured to rotate within receptacle 124. Handle portion 128 can extend from rotation portion 130 to provide a place for a user or operator to place fingers to apply rotational force to wheel 120. Proximal end face 132 of proximal portion 40 from which shaft 20 extends can be flat to allow hub 116 of actuator 18 to abut flush thereagainst, such as when actuator 18 is fully actuated to extend shaft 20 to its most distal position.

[0081] Application of rotational force to wheel 120 can in turn cause shaft 20 to rotate through coupling provided by pin 88. Threaded engagement between shaft 20 and central bore 94 can cause rotation of shaft 20 to cause axialdisplacement of shaft 20 along axis AA. For example, clockwise rotation of wheel 120 can cause distal advancement of shaft 20 and counter-clockwise rotation of wheel 120 can cause proximal advancement of shaft 20. Thus, the threaded engagement between shaft 20 and central bore 94 can provide a mechanical advantage in advancing shaft 20. The axial force generated by shaft 20 can be used to stretch and compress prosthetic valve device 70, discussed herein.

[0082] FIG. 8 is a close-up cross-sectional view of frame holder assembly 22 of FIG. 5 comprising frame holder 54A, frame holder 54B and frame holder 54C. FIG. 9 is a perspective view of frame holder assembly 22 of FIG. 8 shown with mandrel 16 removed to show cutout 98 A, cutout 98B and cutout 98C for frame holder 54A, frame holder 54B and frame holder 54C, respectively. FIG. 8 and FIG. 9 are discussed concurrently.

[0083] Main barrel 14 can have distal end face 140 into which cutout 98A through cutout 98C can extend. Central bore 94 can penetrate through distal end face 140 such that shaft 20 can extend from distal end face 140. Distal end face 140 can be flat to allow mandrel 16 or clamp 90 to abut flush thereagainst.Distal end face 140 can be connected to outer surface 142 of mandrel 16 via radiused surface 144. Cutout 98A can extend radially outward to pass through outer surface 142. Cutout 98A can comprise axially extending floor 146A and radially extending rear wall 148 A. Cutout 98B and cutout 98C can include similar axially extending floors and radially extending walls, though not numbered in FIG. 9 for simplicity. Main barrel 14 can additionally include bore 150A and bore 152A extending into outer surface 142 to intersect cutout 98 A. Bores for cutout 98 and 98C can also be included on main barrel 14 for frame holder 54B and frame holder 54C, respectively.

[0084] FIG. 10 is a perspective view of frame holder 54 A connected to pin 82A. Frame holder 54A can comprise base 154, bore 156, extension 158 and hook 160.

[0085] Base 154 can be positioned within cutout 98 A. Base 154 can comprise a rounded portion that allows for frame holder 54A to rotate within cutout 98A without binding. Extension 158 can extend from base 154 and can provide a lever for connecting to hook 160. Extension 158 can be long enough to position hook 160 outside of cutout 98 A.

[0086] Hook 160 can comprise an attachment feature to attach, connect or couple to prosthetic valve device 70. In the illustrated example, frame holder 54A comprises a single hook. However, frame holder 54A can be configured to have multiple hooks, such as two hooks or three hooks, similar to what is shown in FIG. 18A and FIG. 21. Additionally, frame holder 54 A can be configured to include other types of attachment features, such as loops of a flexible material, pegs, latches, sections of tether or the like, or any combination of hooks, loops, pegs, latches, sections of tether or the like. The frame holders can be configured to attached to prosthetic valve device 70 and allow the attachment point to move radially inward and axially distally to allow prosthetic valve device 70 to be radially compressed or collapsed and axially extended. FIG. 8 illustrates hook 160 facing outward such that a tip of hook 160 is radially outward of extension 158. However, hook 160 can be configured to face inward such that the tip of hook 160 is radially inward of extension 158. The distal tip of frame holder 54A can be rounded to prevent binding against prosthetic valve device 70.

[0087] Returning to FIG. 8 and FIG. 9, frame holder 54A, frame holder 54B and frame holder 54C can rotate on peg 80A, peg 80B and peg 80C, respectively, to position hooks 160 radially outwardly of bases 154 to be positioned to engage with prosthetic valve device 70 in an expanded state. Thereafter, as mandrel 16 and rotating hub 26 are moved distally to move prosthetic valve device 70 distally, frame holder 54A, frame holder 54B and frame holder 54C can rotate on peg 80A, peg 80B and peg 80C, respectively, radially inwardly to pull on portions of prosthetic valve device 70 attached thereto.

[0088] FIG. 11 is a close-up cross-sectional view of capture mechanism 170 comprising gripping handle 24 and rotating hub 26 of FIG. 5 showing peg 80A for connecting to prosthetic valve device 70 of FIG. 3. FIG. 12 is a perspective cross-sectional view of mandrel 16 showing peg 80 A, peg 80B and peg 80C for connecting to prosthetic valve device 70. Gripping handle 24 and rotating hub 26 can be disposed on shaft portion 44 of mandrel 16, such as to be concentric with axis AA. FIG. 11 and FIG. 12 are discussed concurrently.

[0089] Grip body 56 can comprise internal bore 100 and pin hole 172. Shaft portion 44 can include pin hole 174. With shaft portion 44 inserted into internal bore 100, grip body 56 of gripping handle 24 can be disposed at the distal-most end of shaft portion 44. In examples, shaft portion 44 can be recessed withininternal bore 100, but can protrude therefrom in other examples. The internal diameter of internal bore 100 and the outer diameter of shaft portion 44 can be sized so that a clearance fit is formed therebetween, such as a sliding fit or a close, free or loose running fit. Grip body 56 can be rotated so that pin hole 172 aligns with pin hole 174. Pin 86 can be inserted into pin hole 172 and pin hole 174. Pin 86 can comprise a pin, such as a coil pin or spring pin that can apply force against pin hole 172 and pin hole 174 when inserted therein to prevent displacement of pin 86. Pin 86 can allow forces applied to grip body 56, such as by a hand of a user, to be transmitted to mandrel 16. Proximal face 176 of grip body 56 can comprise counterbore 178 surrounding internal bore 100. Counterbore 178 can provide a cavity for receiving the distal end portion of spring 84. Gripping handle 24 can provide an axially immobilized backstop against which spring 84 can push.

[0090] Rotating hub 26 can comprise hub body 180 comprising clasp portion 58, cut-out 60, grip portion 62 and internal bore 182. With shaft portion 44 inserted into internal bore 182, hub body 180 of rotating hub 26 can be disposed at the proximal-most end of shaft portion 44. Furthermore, coupling portion 45 can be located inside internal bore 182 so that clasp portion 58 covers peg 80A, peg 80B and peg 80C. The illustrated example includes a single instance of cutout 60 extending into proximal edge 188 of clasp portion 58. However, multiple instances of cut-out 60 can be included such that proximal edge 188 comprises a crenelated edge.

[0091] Internal bore 182 can have pocket 99 where the internal diameter of internal bore 182 is enlarged to receive spring 84. Internal bore 182 can have widened portion 184 where the internal diameter of internal bore 182 is enlarged to receive coupling portion 45 of mandrel 16. The internal diameter of internal bore 182 and the outer diameter of shaft portion 44 can be sized so that a clearance fit is formed therebetween, such as a sliding fit or a close, free or loose running fit. Hub body 180 can be rotatably disposed about shaft portion 44. For example, when assembled, hub body 180 can rotate about axis AA. Spring 84 can push hub body 180 proximally.

[0092] Internal bore 182 can include proximal face 186 and widened portion 184 can include distal face 187 that can be configured to engage with each other. Spring 84 can push hub body 180 proximally so that proximal face 186 engageswith distal face 187 to prevent further proximal movement of hub body 180. In examples, proximal face 186 and distal face 187 can be angled to provide radial immobilization to hub body 180 when engaged. Engagement of proximal face 186 and distal face 187 can position hub body 180 proximally forward such that proximal edge 188 is positioned proximally of peg 80A, peg 80B and peg 80C and the base or bottom, e.g., distal-most end of cut-out 60 is distal of peg 80A, peg 80B and peg 80C. As such, when hub body 180 is proximally positioned (to the left in FIG. 11), portions of proximal edge 188 can cover peg 80A, peg 80B and peg 80C so that portions of prosthetic valve device 70 attached to peg 80A, peg 80B and peg 80C are prevented from being radially displaced off of peg 80A, peg 80B and peg 80C. When hub body 180 is retracted to be distally positioned (to the right in FIG. 11), such as by actuation of a user or operator, portions of proximal edge 188 can uncover peg 80A, peg 80B and peg 80C so that portions of prosthetic valve device 70 attached to peg 80A, peg 80B and peg 80C can be radially displaced off of peg 80A, peg 80B and peg 80C. As discussed herein, hub body 180 can be rotated so that cut-out 60 can be positioned above each of peg 80A, peg 80B and peg 80C to facilitate attaching one portion of prosthetic valve device 70 to capture mechanism 170 at a time. After loading of prosthetic valve device 70, hub body 180 can be rotated to position cut-out 60 between adjacent pegs. Hub body 180 can also be displaced distally to expose all three of peg 80A, peg 80B and peg 80C at the same time to allow attaching of three portions of prosthetic valve device 70 at the same time.

[0093] FIG. 13 A is a side view of prosthetic valve device 70 in an expanded stated positioned around mandrel 16 of stretching device 10 of the present disclosure. Prosthetic valve device 70 can comprise expandable frame 190 having atrial portion 192 and ventricular portion 194. Atrial portion 192 can comprise atrial attachment features 196 and ventricular portion 194 can comprise ventricular attachment features 198.

[0094] Expandable frame 190 can be in a collapsed state for delivery into the heart and an expanded state for deployment in anatomy of a biological entity, e.g., an animal or a human. Expandable frame 190 can comprise a laser cut tube, wire mesh or wire connected in a diamond-shape pattern that can be expanded from a tubular-like state to a larger annulus. In examples, prosthetic valve device 70 can be configured according to the valves described in WO2022 / 116140 Al to Lane et al., titled “Prosthetic heart valve device, system, and methods,” the contents of which are hereby incorporated by reference.

[0095] In examples, atrial attachment features 196 can comprise tabs, such as mushroom heads, extending from a portion of wire forming expandable frame 190. In examples, ventricular attachment features 198 can comprise holes or bores extending through a plate connected to wire forming expandable frame 190. Atrial portion 192 can be configured to connect to frame holder assembly 22 and ventricular portion 194 can be configured to connect to capture mechanism 170. In particular, frame holder 54A, frame holder 54B and frame holder 54C can be connected to a wire of atrial portion 192, and ventricular attachment features 198 can be connected to peg 80 A, peg 80B and peg 80C. Yet more particularly, hooks 160 of frame holder 54 A, frame holder 54B and frame holder 54C can be connected to a wire portion of atrial portion 192 near atrial attachment features 196, and peg 80A, peg 80B and peg 80C can be inserted into holes of ventricular attachment features 198.

[0096] FIG. 13B is a side view of stretching device 10 of FIG. 13 A showing ventricular portion 194 of prosthetic valve device 70 moved closer to mandrel 16 and rotating hub 26. In particular, expandable frame 190 can be manually compressed, such as by squeezing by a hand of a user or operator. Ventricular portion 194 can be squeezed or compressed to bring ventricular attachment features 198 into close proximity to proximal edge 188.

[0097] FIG. 13C is a side view of stretching device 10 of FIG. 13B with rotating hub 26 rotated to expose peg 80B for coupling to prosthetic valve device 70. Clasp portion 58 of rotating hub 26 can be rotated to align cut-out 60 with peg 80B. Prosthetic valve device 70 can be rotated to align one of ventricular attachment features 198 with cut-out 60 and peg 80B.

[0098] FIG. 13D is a side view of stretching device 10 of FIG. 13C with ventricular attachment feature 198 of prosthetic valve device 70 attached to peg 80B. As mentioned, ventricular attachment feature 198 can comprise a bore or aperture into which peg 80B can be placed. Ventricular attachment feature 198 can be positioned over, e.g., radially outward of, peg 80B and can then be moved radially inward, such as by compressing prosthetic valve device 70, to move ventricular attachment feature 198 around peg 80B. After placement of ventricular attachment feature 198 around peg 80B, rotating hub 26 can berotated to position a portion of clasp portion 58 above, e.g., radially outward of, peg 80B to trap ventricular attachment feature 198 between clasp portion 58 and mandrel 16. Rotating hub 26 can be additionally rotated to position cut-out 60 adjacent peg 80 A or peg 80C so that other ventricular attachment features 198 of prosthetic valve device 70 can be attached to capture mechanism 170.

[0099] FIG. 13E is a side view of stretching device 10 of FIG. 13D showing atrial portion 192 of prosthetic valve device 70 connected to frame holder assembly 22. Prosthetic valve device 70 can be squeezed or compressed by a user to bring atrial attachment features 196 into close proximity to frame holder 54A, frame holder 54B and frame holder 54C of frame holder assembly 22. Hooks 160 of frame holder 54 A, frame holder 54B and frame holder 54C can be connected to a wire portion of atrial portion 192 near atrial attachment features 196. In examples, frame holder 54A, frame holder 54B and frame holder 54C can be rotated radially inward proximate mandrel 16. Prosthetic valve device 70 can be slid proximally toward frame holder assembly 22 one of atrial attachment features 196 rotationally aligned with one of frame holder 54 A, frame holder 54B and frame holder 54C. Thereafter, each of frame holder 54 A, frame holder 54B and frame holder 54C can be rotated radially outward to connect to prosthetic valve device 70. Prosthetic valve device 70 can be released to permit radially outward expansion. Hooks 160 can maintain engagement with atrial attachment features 196 due to tension provided by expansion force of prosthetic valve device. 70.

[0100] FIG. 13F is a side view of stretching device 10 of FIG. 13E showing prosthetic valve device 70 fully loaded into the stretching device 10 ready to be stretched. Ventricular portion 194 can be connected to capture mechanism 170 of rotating hub 26 and atrial portion 192 can be connected to frame holder assembly 22. Expandable frame 190 can be fully or partially radially expanded and held in place by capture mechanism 170 and frame holder assembly 22.

[0101] Actuator 18 can be utilized to facilitate loading of prosthetic valve device 70 into stretching device 10. For example, actuator 18 can be operated to move capture mechanism 170 closer to or further away from frame holder assembly 22 to facilitate attachment of ventricular portion 194 to capture mechanism 170 and atrial portion 192 to frame holder assembly 22 to, for example, match the length of prosthetic valve device 70 and to apply tension toprosthetic valve device 70 to maintain engagement with frame holder assembly 22.

[0102] FIG. 13 A through FIG. 13F are discussed with reference to loading or attaching ventricular portion 194 to capture mechanism 170 first and then loading or attaching atrial portion 192 to frame holder assembly 22 second. However, the procedure can be reversed such that atrial portion 192 can be loaded or attached to frame holder assembly 22 first and ventricular portion 194 can be loaded or attached to capture mechanism 170 second.

[0103] FIG. 14A and FIG. 14B are a perspective views of retaining sleeve 300 of the present disclosure that can be used with the stretching devices of the present disclosure to facilitate collapsing and stretching of prosthetic valves and to retain the prosthetic valves in a collapsed and stretched state. Retaining sleeve 300 of FIG. 14A and FIG. 14B can comprise flared region 305 at a first end, straight region 310 at a second end opposite the first, and transition region 315 adjacent to both flared region 305 and straight region 310 therebetween. Flared region 305 has a first diameter that is suitable for the containment and radial constraint of prosthetic valve device 70 (FIG. 3). Straight region 310 has a second diameter, smaller than the first, that is also suitable for the containment and radial constraint of a prosthetic valve device 70 (FIG. 3).

[0104] Flared region 305 can comprise a cone-shaped region or a parabolicshaped region. Straight region 310 can comprise a cylindrical region. The inner diameter of a first end of flared region 305 can be larger than the outer diameter of prosthetic valve device 70 in an expanded state and a second opposite end of flared region 305 can be smaller than the outer diameter of prosthetic valve device 70. The inner diameter of flared region 305 can taper or slope inward toward the center axis of retaining sleeve 300 to become smaller. Transition region 315 can comprise a curved or flat portion connecting flared region 305 and straight region 310. Straight region 310 can have an inner diameter that is smaller than the inner diameter of flared region 305. The inner diameter of straight region 310 can be constant along its length along the center axis of retaining sleeve 300.

[0105] FIG. 15 is side view of prosthetic valve device 70 and stretching device 10 of FIG. 13F with retaining sleeve 300 of FIG. 14A and FIG. 14B positioned over prosthetic valve device 70 while loaded on stretching device 10.In such an embodiment, the internal diameter of retaining sleeve 300 can be suitably small to hold prosthetic valve device in a collapsed state compatible with delivery system 7000 (FIG. 23 A) after removal from stretching device 10. The inner diameter of retaining sleeve 300 can be sized to fit over gripping handle 24 and rotating hub 26. Prosthetic valve device 70 can be loaded into stretching device 10 as described herein. After actuator 18 is used to collapse and stretch prosthetic valve device 70, retaining sleeve 300 can be slid over gripping handle 24 and onto prosthetic valve device 70 (to the left in FIG. 15. Flared region 305 can help guide prosthetic valve device 70 into retaining sleeve 300 without an edge of retaining sleeve 300 catching on rotating hub 26 or prosthetic valve device 70. Retaining sleeve 300 can be slid over a central portion of expandable frame 190, similar to what is shown in FIG. 18A for cylindrical retaining sleeve 400.

[0106] FIG. 16 illustrates cylindrical retaining sleeve 400 having first diameter 405 and second diameter 410 whereby first diameter 405 is an outer diameter and second diameter 410 is an inner diameter and smaller than the first. Cylindrical retaining sleeve 400 further has a length defined by first end 425 and second end 430 opposite the first. Adjacent first end 425 of cylindrical retaining sleeve 400 is tapered edge 415 that can be used to shoehorn a portion of prosthetic valve device 70 (FIG. 3) for loading assistance. Tapered edge 415 can act as a funnel to push material of expandable frame 190 radially inward. Tapered edge 415 can comprise an internal funnel, whereas flared region 305 of retaining sleeve 300 can comprise an external funnel. In other words, tapered edge 415 can comprise an angled or curved surface within the cylindrical outer diameter of first diameter 405, whereas flared region 305 can extend outside of the outer diameter of straight region 310. Adjacent second end 430 of cylindrical retaining sleeve 400 is alignment slot 420, that can be used to register cylindrical retaining sleeve 400 against an extension device. For example, alignment slot 420 can align with support legs 1045 of stretching device 1000 (FIG. 18 A).

[0107] FIG. 17 illustrates an isometric view of prosthetic valve device 70 radially compressed inside of cylindrical retaining sleeve 400, thereby forming detachment 450. Detachment 450 can comprise prosthetic valve device 70 positioned within cylindrical retaining sleeve 400 ready to be loaded ontodelivery system 7000 of FIG. 23 A. As such, cylindrical retaining sleeve 400 holds prosthetic valve device 70 at a desired diameter so that ventricular attachment feature 198 are in position to join with retaining peg 7040 as discussed with reference to FIG. 23C. FIG. 17 shows detachment 450 comprising prosthetic valve device 70 with cylindrical retaining sleeve 400, but another similar detachment can be formed with prosthetic valve device 70 and retaining sleeve 300 of FIG. 14 A.

[0108] FIG. 18A depicts prosthetic valve device 70 in a connected and semireleased state, and cylindrical retaining sleeve 400 positioned over prosthetic valve device 70. Additionally, stretching device 1000 is shown with prosthetic valve device 70 being prepared for removal. Thus, FIG. 18A shows detachment 450 of FIG. 17 attached to stretching device 1000 prior to detachment. As discussed below with reference to FIG. 19A to FIG. 21, stretching device 1000 can comprise another design of stretching device 10 that can be used as an alternative to stretching device 10.

[0109] After stretching device 10 or stretching device 1000 is used to radially compress and axially stretch prosthetic valve device 70, detachment 450 can be separated from the extension device for mating with delivery system 7000. Thus, to remove prosthetic valve device 70 from the extension device, translating clasp 1075, similar to rotating hub 26 (FIG. 1), can be pulled distally, to the left in FIG. 18 A, to release ventricular attachment features 198 therefrom.

[0110] Call-out circle 460 shows prosthetic valve device 70 detached from first capturing mechanism 1010. Stretching device 1000 is shown releasing prosthetic valve device 70 into cylindrical retaining sleeve 400 that is positioned over prosthetic valve device 70. By translating clasp 1075 (to the left in FIG. 18 A) away from ventricular attachment features 198, ventricular attachment features 198 can become individually or collectively released from capture and free to expand radially outward. Likewise, rotating hub 26 (FIG. 1) can be translated to away from ventricular attachment features 198 to release all of ventricular attachment features 198 at the same time. Alternatively, rotating hub 26 (FIG. 1) can be rotated to align cut-out 60 with each of peg 80 A, peg 80B and peg 80C to individually release ventricular attachment features 198 one at a time.

[0111] FIG. 18B illustrates the de-coupling of captured prosthetic valve device 70 from stretching device 1000. By rotating and unthreading (arrow 470symbolizing rotation) first capturing mechanism 1010 from threaded portion 1080 of translating shaft 1020, the first capturing mechanism 1010 can be translated (to the left in FIG. 18B) away from translating shaft 1020 to provide clearance for removal of the captured prosthetic valve device 70 and cylindrical retaining sleeve 400, thereby allowing for detachment 450 of cylindrical retaining sleeve 400 and prosthetic valve device 70 retained therewithin. The aforementioned detachment 450, comprising cylindrical retaining sleeve 400 and prosthetic valve device 70, are illustrated and provided in FIG. 17. Likewise, mandrel 16 (FIG. 1) can be detached from shaft 20 by sliding off of insertion portion 52. Once frame holder assembly 22 is detached form prosthetic valve device 70, there are no other mechanical couplings preventing mandrel 16 from being slid off of insertion portion 52.

[0112] FIG. 19A is a perspective view of stretching device 1000 of the present disclosure in an extended state, wherein stretching device 1000 includes a spring-loaded, cam-actuated stretching mechanism. FIG. 19B is a perspective view of the stretching device 1000 of FIG. 19A in a retracted state. FIG. 19A and FIG. 19B are discussed concurrently. Stretching device 1000 can comprise an extension device configured to extend prosthetic valve device 70 into an elongated, radially collapsed, state.

[0113] Reference is made to FIG. 19A, which is a schematic illustration showing an isometric aspect of stretching device 1000 in an axially extended state, in accordance with some applications of the invention. Stretching device 1000 is generally comprised of base 1040 which is further comprised of support legs 1045 and acts as a support component for main barrel 1050. Base 1040 can comprise a stand that is configured to receive main barrel 1050 so that first capturing mechanism 1010 of stretching device 1000 can be extended away from base 1040, e.g., cantilevered therefrom, to allow first capturing mechanism 1010 to be hung or suspended over a fluid filled basin. Main barrel 1050 can comprise a support body that provides bearing support for linear displacement of translating shaft 1020 in a horizontal direction. Stretching device 1000 is further comprised of translating shaft 1020 having a first end and a second end opposite the first, wherein translating shaft 1020 extends throughout and is concentrically aligned with main barrel 1050, barrel cap 1090 affixed to said main barrel 1050, and extension knob 1055 that is in mated contact with and terminates translatingshaft 1020 at the second end. In other examples, translating shaft 1020 and main barrel 1050 can be offset, but axially aligned, without one being inside the other. First capturing mechanism 1010 for capturing a first end of prosthetic valve device 70 (FIG. 3) is located at and in mated connection with the first end of translating shaft 1020. Second capturing mechanism 1030 for capturing a second end of prosthetic valve device 70 (FIG. 3) is located on main barrel 1050 in a position opposite first capturing mechanism 1010, so as to form an opposing pair of capturing mechanisms that collectively function as a stretching mechanism for radially collapsing a prosthetic valve device 70 (FIG. 3) from an un-collapsed state. First capturing mechanism 1010 is further comprised of spring knob 1065 that terminates the first end of translating shaft 1020, and that also provides abutment for clasp spring 1070 which is co-axially aligned with translating shaft 1020 and which provides bias force between spring knob 1065 and clasp 1075 so as to force clasp 1075 into a closed position (to the right in FIG. 19A). First capturing mechanism 1010 thus forms a spring biased, or spring-loaded, mechanism having a first, locked state (similar to FIG. 13B), and a second, unlocked state (similar to FIG. 13C) wherein when in the locked state first capturing mechanism 1010 can be slid or translated to lockably clasp a first end of prosthetic valve device 70 (FIG. 3) for retention. Furthermore, clasp 1075 can be rotated into open and closed positions where either one of pegs 3035 (FIG. 18A) is positioned below clasp window 6044 (FIG. 18A) in an open position or all of pegs 3035 are covered by a portion of clasp 1075 in a closed position such that clasp window 6044 is not adjacent any of pegs 3035.

[0114] Stretching device 1000 further comprises cammed lever 1060 (shown in a closed position in FIG. 19A) that is in rotational connection with an end of main barrel 1050 and mounted directly to barrel cap 1090 and is further positioned to be adjacent extension knob 1055 that is in mated contact with translating shaft 1020. Cammed lever 1060 has a cam surface that engages an opposing surface on extension knob 1055. The cam surface can slide against extension knob 1055 when actuated. When cammed lever 1060 is rotated into an open position (FIG. 19B) as depicted by the arrow 1100 symbolizing cammed lever rotation, translating shaft 1020 and all components which are in mated connection to it (first capturing mechanism 1010, extension knob 1055) translate from a first position represented by an extended distance dl (FIG. 19A), to asecond position represented by a retracted distance d2 as depicted in FIG. 19B. This collective motion is represented by the arrow 1105 symbolizing translation of the extension knob, and the state of being in the second position is depicted by stretching device 1000, in a retracted state. The extent of the translation is directly related to the profile, e.g., shape or curvature, of cammed lever 1060. The profile of cammed lever 1060 is further designed to provide a locking state when cammed lever 1060 is fully retracted. Clearance slot 1110 (FIG. 19A) provides clearance for translating shaft 1020 to travel within cammed lever 1060.

[0115] First capturing mechanism 1010 may function collectively with second capturing mechanism 1030 by acting in opposition to the second capturing mechanism and providing reactionary force in the form of tension. Second capturing mechanism 1030 comprises a plurality of grasping elements such as frame holders 1052 (FIG. 19B) that are mounted upon hinged joints 1035 and positioned within hinge pockets 1081 that appear on an end of main barrel 1050 adjacent to and concentrically positioned about translating shaft 1020. Hinged joints 1035 can comprises pins extending into the end of main barrel 1050 across hinge pockets 1081 to intersect ends of frame holders 1052 located therein. It should be recognized that the terms “grasping elements” and “frame holders” should not be construed as limiting, and that grasping elements may be interpreted as any plurality of one or more hooks, loops, pegs, latches, sections of tether or the like, or any combination of hooks, loops, pegs, latches, sections of tether or the like. When prosthetic valve device 70 (FIG. 3) is mounted to and placed between first capturing mechanism 1010 and second capturing mechanism 1030, tension may be created and directed along a central axis of said exemplary heart valve device by displacing said capturing mechanisms away from each other through translating motion that is affected through cammed lever manipulation. The details of these interactions are similar to those described with reference to FIG. 13 A through FIG. 13F.

[0116] Frame holders 1052 can rotate between an open state (similar to frame holders54A, frame holder 54B and frame holder 54C in FIG. 1) and a closed state (similar to frame holders54A, frame holder 54B and frame holder 54C in FIG. 13 A). Frame holders 1052 can rotate freely at hinged joints 1035 orcan be biased to the open or closed position by appropriate biasing elements, e.g., springs.

[0117] Clasp 1075 can be in a locked state translated to the right in FIG. 19A and FIG. 19B and an unlocked state where clasp 1075 is displaced to the left from what is shown in FIG. 19A and FIG. 19B to expose pegs 3035 as shown in FIG. 18 A. Furthermore, Clasp 1075 can be in a closed state, similar to clasp portion 58 in FIG. 13B, and an open state, similar to clasp portion 58 in FIG. 13C. Clasp 1075 can include knurled gripping texture on its body that can be grasped to achieve translation by overcoming force of clasp spring 1070. Once the body of clasp 1075 has been translated, a pocket or depression in which peg 3035 is located may become revealed, wherein peg 3035 is housed. The interaction of the leading edge of clasp 1075 with peg 3035 creates a clasping mechanism that may be used to entrain and capture a portion of prosthetic valve device 70 (FIG. 3) for radial collapse.

[0118] FIG. 20 is a top view of stretching device 1000 of FIG. 19A and FIG. 19B in and extended state. FIG. 21 is a side-cross sectional view of stretching device 1000 of FIG. 20 showing a cam mechanism and a biasing spring. FIG. 20 and FIG. 21 are discussed concurrently.

[0119] With reference to FIG. 20 and FIG. 21, overhead and sectioned views of stretching device 1000 are provided. In FIG. 20, an overhead view of stretching device 1000 in an extended state is provided. A section line 21-21 is illustrated in order to create the view provided in FIG. 21, which illustrates the resultant cross section of stretching device 1000. The internal mechanisms of the exemplary extension device are more readily understood when viewed through the cross section provided in FIG. 21 and shall now be described. Translating shaft collar 4015 is rigidly mated to translating shaft 1020 (FIG. 22A) by way of set screw 4030 that can apply frictional force against translating shaft 1020. Translating shaft collar 4015 provides abutment and registration for translating shaft return spring 4020, which is captured between both translating shaft collar 4015 on a first end, and barrel plug 4025 on a second end, opposite the first. When compressed, translating shaft return spring 4020 provides bias force against translating shaft collar 4015 and by extension translating shaft 1020 in such a direction as would drive the translating shaft away from main barrel 1050 thus increasing the retracted distance (d2, FIG. 19B) to such an extent thatit becomes an extended distance (dl, FIG. 19A). Further, when compressed, stretching device 1000 is in a state whereby prosthetic valve device 70 (FIG. 3) may be placed into position for extension.

[0120] FIG. 22A is a perspective view of stretching device 8000 of the present disclosure in an extended state, wherein stretching device 8000 includes bolt-action actuation mechanism. FIG. 22B is a perspective view of stretching device 8000 of FIG. 19A in a retracted state. FIG. 22 A and FIG. 22B are discussed together.

[0121] With reference to FIGS. 22 A and 22B, depictions of stretching device 8000 for radially collapsing prosthetic valve device 70 (FIG. 3), with stretching device 8000 transitioning between an axially extended state (FIG. 22A) and an axially retracted state (FIG. 22B), are provided. FIG. 22A and FIG. 22B illustrate a bolt action type extension device. More specifically, FIG. 22A provides an alternative embodiment of an extension device in the extended position, generally comprised of a translating shaft having distal section 8002, and proximal section 8003 opposite the distal section, and a rigid shaft body therebetween. Main barrel 8050 provides housing for translating shaft 8020 to translate concentrically throughout, moving from an extended position, as depicted by FIG. 22 A, to a retracted position, as depicted by FIG. 22B. Main barrel 8050 can be constructed similarly to main barrel 1050 of FIG. 19A. Distal retraction knob 8005 is in mated connection with the translating shaft 8020, and it can be used to both retract and extend the translating shaft 8020 by way of translation within a positioning slot 8010 that guides distal retraction knob 8005 from a first position (as depicted in FIG. 22 A) to a second position adjacent a locking portion region 8015 of the positioning slot 8010 (axial translation symbolized by arrow 8030). Ends of positioning slot 8010 can comprise locking detents for distal retraction knob 8005. When translating shaft 8020 is retracted (axial translation represented by arrow 8025) from the extended position (FIG. 22A), proximal retraction knob 8035 which is in mated connection with translating shaft 8020 at proximal section 8003 translates as well, from a first extended distance d5 to a second retracted distance d6, FIG. 22B.

[0122] Turning now to FIG. 23 A - 23K, a sequence of exemplary steps or operations in the operation of an exemplary loading tool, with an exemplary prosthetic heart valve device, such as prosthetic valve device 70, loaded into anexemplary delivery system, is illustrated. More specifically, FIG. 23A describes delivery system 7000, with loading tool 7005 in connected fashion, and an exemplary prosthetic heart valve device compressed within retaining sleeve 5000 for transfer into the delivery system. The process through which the prosthetic heart valve device is further compressed and inserted within catheter 7015 of delivery system 7000 will now be described. With reference to FIG. 23B, catheter 7015 of delivery system 7000 is shown in a withdrawn and translated position (arrow 7030 symbolizing axial translation), revealing a prosthetic heart valve retention region 7020 within the exemplary delivery system. Details of the inner mechanical workings of delivery system 7000 are not provided. Examples of delivery systems suitable for use with the prosthetic heart valves of the present disclosure are described in WO 2022 / 116140 Al to Lane et al., titled “Prosthetic heart valve device, system, and methods,” the contents of which are hereby incorporated by reference. Enlarged view circle 7025 is provided, which results in the view of FIG. 23C. With reference to FIG. 23C, retaining peg 7040 within retaining peg pocket 7035 are provided adjacent the prosthetic heart valve retention region 7020 and are configured so as to releasably connect to an exemplary prosthetic heart valve device, the details of which shall be provided further below.

[0123] With reference to FIG. 23D, the exemplary prosthetic heart valve device compressed within retaining sleeve 5000 of FIG. 23C is shown translated (arrow 7045 symbolizing axial translation) and is illustrated as positioned for loading 7050, being located within prosthetic heart valve retention region 7020 of delivery system 7000. Turning to FIG. 23E, detail regarding loading tool 7005 is provided. Loading tool 7005 is comprised of tapered section 7055 having first diameter 7065 and tapered inner surface 7060, and straight section 7071 having second diameter 7070 smaller than the first, and a straight inner surface (not shown in FIG. 23D) that is adjacent to and continuous with tapered inner surface 7060. Loading tool 7005 functions as a funnel, providing a smooth surface that transitions from larger first diameter 7065 to smaller second diameter 7070, said surface providing a guide for further radial compression of an exemplary prosthetic heart valve device, when said heart valve device is pressed into said loading tool. Loading tool 7005 may be sized advantageously so as to concentrically rest over catheter 7015 when in position, prior to use.

[0124] Turning now to FIG. 23F, detail regarding the connection of the exemplary prosthetic heart valve device compressed within retaining sleeve 5000 of FIG. 23 A to the exemplary delivery system is provided. More specifically, arrows 7075 symbolizing radial translation of ventricular attachment features 6030 into retaining peg pocket 7035 depict the movement of ventricular attachment features 6030 into a position that enables capture. Enlarged view circle 7080 provides the view of resultant FIG. 23 G, which illustrates the interaction between the exposed portion of retaining hub 7085 of delivery system 7000 and connection 7090 between retaining peg 7040 and the foremost ventricular attachment feature 6030. FIG. 23G illustrates the exemplary ventricular attachment features in radially collapsed position within corresponding peg pockets, and in connection with corresponding pegs. This final radial compression may be achieved manually with the operator’s digital manipulation (e.g., with the use of fingers and thumbs of a hand) of the ventricular attachment features into position within the peg pockets (hand manipulation not illustrated). With reference to FIG. 23H, the capture of the entrained ventricular attachment features 6030 within catheter 7015 of delivery system 7000 is illustrated. Arrow 7095 symbolizing axial translation depicts the forward translation of leading edge 7100 of catheter 7015, thus capturing ventricular attachment features 6030 and preventing radial expansion of said ventricular attachment features.

[0125] With reference to FIG. 231 through FIG. 23K, the full capture of prosthetic heart valve device 7115 within delivery system 7000 is illustrated. More specifically, FIG. 231 depicts the forward translation of loading tool 7005 (arrow 7105 symbolizing axial translation) onto the partially captured prosthetic heart valve device 7115. Loading tool 7005 assists in further radially compressing the prosthetic heart valve device, allowing it to be reduced to a diameter suitable for full capture and ensheathment by catheter 7015. Arrow 7110 of FIG. 23 J symbolizes the final axial translation of loading tool 7005 over and off of the prosthetic heart valve device. Arrow 7120 of FIG. 23K symbolizes the final closure of catheter 7015 over the partially captured prosthetic heart valve device (not shown in FIG. 23K, captured internally), resulting in the exemplary delivery system being fully loaded with the exemplary prosthetic heart valve device (not shown in FIG. 23K).

[0126] FIG. 24 is block diagram illustrating operations in method 500 of loading prosthetic valve device 70 into stretching device 10. Though discussed with reference to stretching device 10 and prosthetic valve device 70, method 500 can encompass the use of any stretching device described herein and any radially compressible and axially stretchable prosthetic device. Method 500 can additionally include fewer or greater operations other than operation 504 to operation 524. Additionally, in other examples, operation 504 through operation 524 can be performed in other sequences.

[0127] At operation 504, prosthetic valve device 70 can be loaded onto stretching device 10. Specifically, mandrel 16 can be inserted into expandable frame 190 so that atrial attachment features 196 are positioned proximate frame holder assembly 22 and ventricular attachment features 198 are positioned proximate capture mechanism 170.

[0128] At operation 506, a first side of prosthetic valve device 70 can be attached to stretching device 10. Specifically, atrial attachment features 196 can be attached to frame holder 54 A, frame holder 54B and frame holder 54C.

[0129] At operation 508, a second side of prosthetic valve device 70 can be attached to stretching device 10. Specifically, ventricular attachment features 198 can be attached to peg 80 A, peg 80B and peg 80C.

[0130] At operation 510, actuator 18 of stretching device 10 can be operated to stretch prosthetic valve device 70. Specifically, handwheel 46 can be rotated to move rotating hub and capture mechanism 170 distally away from main barrel 14 and frame holder assembly 22. Thus, expandable frame 190 of prosthetic valve device 70 can be radially collapsed and axially stretched. In examples, prosthetic valve device 70 can be collapsed around a mandrel to influence the collapsed shape of the prosthetic valve device 70 and prevent infolding, e.g., radially inward bulging of the frame of prosthetic valve device 70.

[0131] At operation 512, retaining sleeve 300 or cylindrical retaining sleeve 400 can be positioned over prosthetic valve device 70. Retaining sleeve 300 or cylindrical retaining sleeve 400 can maintain prosthetic valve device in the radially compressed and axially stretched state.

[0132] At operation 514, a first side of prosthetic valve device 70 can be detached from stretching device 10. Specifically, atrial attachment features 196can be unhooked from frame holder 54A, frame holder 54B and frame holder 54C.

[0133] At operation 516, a second side of prosthetic valve device 70 can be detached from stretching device 10. Specifically, ventricular attachment features 198 can slid off of peg 80A, peg 80B and peg 80C.

[0134] At operation 518, mandrel 16 can be detached from stretching device 10. Specifically, mandrel 16 can be removed from insertion portion 52 of shaft 20.

[0135] At operation 520, detachment 450 can be removed from stretching device. Detachment 450 can comprise prosthetic valve device 70 surrounded by retaining sleeve 300 or cylindrical retaining sleeve 400.

[0136] At operation 522, prosthetic valve device 70 can be attached to delivery system 7000.

[0137] At operation 524, retaining sleeve 300 or cylindrical retaining sleeve 400 can be removed from prosthetic valve device 70.

[0138] The stretching devices of the present application offer several benefits and advantages, particularly in the context of preparing prosthetic heart valve devices for implantation. A summary of some of the benefits is provided below.

[0139] Ease of Preparation: The stretching devices facilitate the preparation of prosthetic heart valves by enabling the compression and elongation of the valve frames into a configuration suitable for delivery through a catheter. This simplifies the complex process of preparing the valve for implantation.

[0140] Mechanical Advantage: The stretching devices incorporate mechanisms such as threaded couplings, levers, cams, or biasing forces like springs, which provide a mechanical advantage. This allows the operator to easily apply the necessary force to compress and stretch the valve without manual strain.

[0141] Safety and Precision: By mechanically controlling the compression and stretching of the prosthetic valve devices, the stretching devices ensure that the procedure is performed with high precision and safety, reducing the risk of damaging the valve during preparation.

[0142] Repeatability: The design of the stretching devices allows for consistent and repeatable preparation of prosthetic valves. This consistency is beneficial for ensuring successful outcomes in surgical procedures.

[0143] User-Friendly Operation: The stretching devices are designed to be user-friendly, requiring minimal manual effort from the operator. Features like gripping handles and rotating hubs facilitate easy handling and operation of the device.

[0144] Versatility: The stretching devices are capable of handling different types and sizes of prosthetic valves, making them versatile tools in various surgical scenarios.

[0145] Enhanced Clinical Outcomes: By ensuring that the prosthetic valve devices are correctly prepared and delivered, the stretching devices contribute to enhanced clinical outcomes, including reduced procedural complications and improved efficacy of valve implantation.

[0146] Reduction in Procedure Time: The efficiency provided by these stretching devices can significantly reduce the time required to prepare the valves for surgery, thereby shortening the overall procedure time and potentially reducing the exposure of patients and surgical staff to prolonged anesthesia and other operative risks.

[0147] Overall, the stretching devices described in the present application provide significant technological advancements that improve the process of preparing prosthetic heart valves for implantation, enhancing both the safety and effectiveness of cardiac surgeries involving valve replacement.Examples

[0148] Example 1 is an extension device for radially collapsing a prosthetic heart valve device, comprising: a shaft comprising a first end and a second end opposite the first end; a support body axially aligned with and configured to provide support for the shaft; an actuation mechanism connected to the support body and configured to provide axial movement to the shaft; a grasping mechanism connected to the support body, the grasping mechanism configured to releasably capture a first portion of a prosthetic heart valve device; and a capturing mechanism connected to the shaft, wherein the capturing mechanism is configured to releasably capture a second portion of the prosthetic heart valvedevice; wherein the shaft is configured to move from a first retracted state whereby the prosthetic heart valve device can be radially un-collapsed when attached to the extension device, to a second extended state whereby the prosthetic heart valve device can be radially collapsed when attached to the extension device.

[0149] In Example 2, the subject matter of Example 1 optionally includes wherein the grasping mechanism comprises a grasping element connected to the support body, the grasping element configured to attach to the first portion of the prosthetic heart valve device with an attachment feature at a first end portion and attach to the support body at a second end portion.

[0150] In Example 3, the subject matter of Example 2 optionally includes wherein the grasping element is one of a plurality of grasping elements.

[0151] In Example 4, the subject matter of any one or more of Examples 2-3 optionally include wherein the attachment feature comprises a hook rotatably connected to the support body.

[0152] In Example 5, the subject matter of Example 4 optionally includes a plurality of hooks.

[0153] In Example 6, the subject matter of any one or more of Examples 1-5 optionally include wherein the capturing mechanism comprises a collar concentrically disposed around the shaft, the collar configured to translate along the shaft.

[0154] In Example 7, the subject matter of Example 6 optionally includes wherein the capturing mechanism further comprises a hub coupled to the shaft, wherein the collar is disposed about the hub.

[0155] In Example 8, the subject matter of Example 7 optionally includes wherein the hub includes a peg for engaging the second portion of the prosthetic heart valve device.

[0156] In Example 9, the subject matter of any one or more of Examples 7-8 optionally include wherein the hub comprises a mandrel extending toward the grasping mechanism, the mandrel configured to influence a shape of the prosthetic heart valve device when radially collapsed.

[0157] In Example 10, the subject matter of Example 9 optionally includes a gripping handle connected to the shaft to hold the mandrel rotationally immobilized when grasped by a user.

[0158] In Example 11, the subject matter of any one or more of Examples 7-10 optionally include wherein the collar is biased toward the grasping mechanism.

[0159] In Example 12, the subject matter of any one or more of Examples 8-11 optionally include wherein the collar further comprises a notch disposed at a proximal edge of the collar, wherein the collar can be rotated to align the notch with the peg.

[0160] In Example 13, the subject matter of any one or more of Examples 8-12 optionally include wherein the hub includes a pocket in which is located the peg-100161] In Example 14, the subject matter of any one or more of Examples 1-13 optionally include wherein the actuation mechanism comprises: a threaded engagement between the shaft and the support body; and a wheel connected to the shaft to provide a rotational input.

[0162] In Example 15, the subject matter of any one or more of Examples 1-14 optionally include wherein the actuation mechanism comprises: a sliding engagement between the shaft and the support body; and a biasing element to push the shaft distally.

[0163] In Example 16, the subject matter of Example 15 optionally includes wherein the actuation mechanism further comprises a cam lever configured to provide cam action, wherein the cam lever is configured to releasably lock the shaft into a locked position at an extent of the cam action.

[0164] In Example 17, the subject matter of any one or more of Examples 15-16 optionally include wherein the actuation mechanism comprises a bolt action.

[0165] In Example 18, the subject matter of any one or more of Examples 1-17 optionally include a retention sleeve disposed about the support body and configured to slide over the prosthetic heart valve device when the prosthetic heart valve device is attached to the extension device in a collapsed state.

[0166] In Example 19, the subject matter of any one or more of Examples 1-18 optionally include wherein the support body further comprises a stand, wherein the stand is configured to position the support body in a horizontal configuration, wherein the stand comprises a detachable base.

[0167] Example 20 is a method of collapsing a radially expandable prosthetic heart valve device to a radially compressed state, the method comprising: loading the radially expandable prosthetic heart valve device onto a shaft of a stretching device; attaching a first end portion of the radially expandable prosthetic heart valve device to a capture mechanism on the shaft; attaching a second end portion of the radially expandable prosthetic heart valve device to a support structure for the shaft; and operating a stretching mechanism of the stretching device to radially collapsed and axially extend the radially expandable prosthetic heart valve device.

[0168] In Example 21, the subject matter of Example 20 optionally includes wherein loading the radially expandable prosthetic heart valve device onto the shaft of the stretching device comprises inserting the shaft into an annular expandable frame of the radially expandable prosthetic heart valve device.

[0169] In Example 22, the subject matter of Example 21 optionally includes wherein attaching the first end portion of the radially expandable prosthetic heart valve device to the support structure for the shaft comprises attaching pivotable hooks extending form the support structure to wires defining the annular expandable frame.

[0170] In Example 23, the subject matter of any one or more of Examples 21-22 optionally include wherein attaching the second end portion of the radially expandable prosthetic heart valve device to the capture mechanism of the shaft comprises inserting pegs of the capture mechanism into holes of the annular expandable frame.

[0171] In Example 24, the subject matter of Example 23 optionally includes wherein attaching the second end portion of the radially expandable prosthetic heart valve device to the capture mechanism of the shaft comprises rotating a clasp to expose the pegs to receive the holes of the annular expandable frame.

[0172] In Example 25, the subject matter of any one or more of Examples 23-24 optionally include wherein attaching the second end portion of the radially expandable prosthetic heart valve device to the capture mechanism of the shaft comprises translating a clasp to expose the pegs to receive the holes of the annular expandable frame.

[0173] In Example 26, the subject matter of any one or more of Examples 20-25 optionally include wherein operating the stretching mechanism of thestretching device to radially collapsed and axially extend the radially expandable prosthetic heart valve device comprises turning a handwheel to rotate the shaft to operate a screw mechanism to move the capture mechanism away from the support structure.

[0174] In Example 27, the subject matter of Example 26 optionally includes grasping a gripping handle attached to the capture mechanism to prevent rotation of the capture mechanism relative to the shaft.

[0175] In Example 28, the subject matter of any one or more of Examples 20-27 optionally include radially collapsing the radially expandable prosthetic heart valve device around a mandrel connected to the shaft to prevent radial infolding of the radially expandable prosthetic heart valve device.

[0176] In Example 29, the subject matter of any one or more of Examples 20-28 optionally include sliding a retaining sleeve over the radially expandable prosthetic heart valve device when radially collapsed and axially extended. Each of these non-limiting examples can stand on its own, or can be combined in various permutations or combinations with one or more of the other examples.Additional Examples

[0177] Example 1 is an extension device for radially collapsing a prosthetic heart valve device, comprising: a translating shaft comprising a first end and a second end opposite the first end, and a knob adjacent the second end; a lever adjacent to and in sliding contact with the knob of the translating shaft and configured to provide for linear displacement of the translating shaft; a support body axially aligned with and configured to provide translational bearing support for the translating shaft, the support body comprising a first end and a second end opposite the first end, wherein the second end of the support body is adjacent to and in rotational connection with the lever; one or more grasping elements adjacent to and in connection with the first end of the support body, the one or more grasping elements configured to releasably capture a first end of a prosthetic heart valve device; and a capturing mechanism adjacent to a disposed upon the first end of the translating shaft, wherein the capturing mechanism is configured to releasably capture a second end of the prosthetic heart valve device, opposite the first end of the prosthetic heart valve device; wherein the translating shaft is configured to translate from a first retracted state whereby theprosthetic heart valve device is radially un-collapsed, to a second extended state whereby the prosthetic heart valve device is radially collapsed, when the prosthetic heart valve device is positioned on and captured by the extension device.

[0178] In Example 2, the subject matter of Example 1 optionally includes wherein the lever further comprises a camming mechanism configured to provide cam action, wherein the lever is configured to releasably lock the translating shaft into a locked position at the extent of the cam action.

[0179] In Example 3, the subject matter of Example 2 optionally includes wherein the support body is further comprised of an internal spring configured to provide bias force against the translating shaft, wherein the bias force is configured to bias the translating shaft to the second extended state.

[0180] In Example 4, the subject matter of Example 3 optionally includes wherein the support body further comprises a stand, wherein the stand is configured to position the support body in a horizontal configuration.

[0181] In Example 5, the subject matter of any one or more of Examples 3-4 optionally include wherein the support body further comprises a detachable base, wherein the detachable base is configured to position the support body in a horizontal configuration.

[0182] In Example 6, the subject matter of any one or more of Examples 1-5 optionally include wherein the one or more grasping elements comprise hooks.In Example 7, the subject matter of any one or more of Examples 1-6 optionally include wherein the one or more grasping elements comprise loops.

[0183] In Example 8, the subject matter of any one or more of Examples 1-7 optionally include wherein the one or more grasping elements comprise pegs.

[0184] In Example 9, the subject matter of any one or more of Examples 1-8 optionally include wherein the one or more grasping elements comprise latches.

[0185] In Example 10, the subject matter of any one or more of Examples 1-9 optionally include wherein the one or more grasping elements comprise sections of tether.

[0186] In Example 11, the subject matter of any one or more of Examples 1-10 optionally include wherein the capturing mechanism comprises a collar concentrically disposed around a hub having one or more retaining pockets.

[0187] In Example 12, the subject matter of Example 11 optionally includes wherein the capturing mechanism further comprises a spring-loaded mechanism that is configured to biased the collar to a closed configuration around the hub.

[0188] In Example 13, the subject matter of Example 12 optionally includes wherein the collar further comprises a window and is further configured to rotate about the hub, thereby aligning the window with any of the one or more retaining pockets of the hub.

[0189] Example 14 is an extension device for radially collapsing a prosthetic heart valve device, comprising: a translating shaft comprising a first end and a second end opposite the first end, and a knob adjacent the second end; a support body axially aligned with and configured to provide translational bearing support for the translating shaft, the support body comprising a first end and a second end opposite the first end, wherein the second end of the support body is adjacent to and in rotational connection with the translating shaft; one or more grasping elements adjacent to and in connection with the first end of the support body, the one or more grasping elements configured to releasably capture a first end of a prosthetic heart valve device; and a capturing mechanism adjacent to a disposed upon the first end of the translating shaft, wherein the capturing mechanism is configured to releasably capture a second end of the prosthetic heart valve device, opposite the first end of the prosthetic heart valve device; wherein the translating shaft is configured to translate from a first retracted state whereby the prosthetic heart valve device is radially un-collapsed, to a second extended state whereby the prosthetic heart valve device is radially collapsed, when the prosthetic heart valve device is positioned on and captured by the extension device.

[0190] In Example 15, the subject matter of Example 14 optionally includes wherein the support body further comprises a set screw mechanism that is configured to apply frictional force against the translating shaft to lock the translating shaft into position.

[0191] In Example 16, the subject matter of any one or more of Examples 14-15 optionally include wherein the support body further comprises a bolt action mechanism that is comprised of a bolt in connection with the translating shaft, and a slot that is configured to allow the bolt to slide between a first boltstate and a second bolt state, wherein the first bolt state results in an extended translating shaft, and the second bolt state results in a retracted translating shaft.

[0192] In Example 17, the subject matter of Example 16 optionally includes wherein the slot further comprises a first locking detent and a second locking detent, and wherein the first locking detent corresponds to the first bolt state, and the second locking detent corresponds to the second bolt state.

[0193] In Example 18, the subject matter of any one or more of Examples 14-17 optionally include wherein the second end of the support body further comprises a threaded region that is configured to threadedly mate with the translating shaft.

[0194] In Example 19, the subject matter of any one or more of Examples17-18 optionally include wherein the support body is further comprised of an internal spring configured to provide bias force against the translating shaft, the bias force configured to bias the translating shaft to the second extended state.

[0195] In Example 20, the subject matter of any one or more of Examples18-19 optionally include wherein the support body further comprises a stand, wherein the stand is configured to position the support body in a horizontal configuration.

[0196] In Example 21, the subject matter of Example 20 optionally includes wherein the stand is further configured to hang the extension device from an edge of a fluid filled basin.

[0197] In Example 22, the subject matter of any one or more of Examples 18-21 optionally include wherein the support body further comprises a detachable base, wherein the detachable base is configured to position the support body in a horizontal configuration.

[0198] In Example 23, the subject matter of Example 22 optionally includes wherein the one or more grasping elements comprise hooks.

[0199] In Example 24, the subject matter of any one or more of Examples 22-23 optionally include wherein the one or more grasping elements comprise loops.

[0200] In Example 25, the subject matter of any one or more of Examples 22-24 optionally include wherein the one or more grasping elements comprise pegs.

[0201] In Example 26, the subject matter of any one or more of Examples 22-25 optionally include wherein the one or more grasping elements comprise latches.

[0202] In Example 27, the subject matter of any one or more of Examples22-26 optionally include wherein the one or more grasping elements comprise sections of tether.

[0203] In Example 28, the subject matter of any one or more of Examples23-27 optionally include wherein the capturing mechanism comprises a collar concentrically disposed around a hub having one or more retaining pockets.

[0204] In Example 29, the subject matter of Example 28 optionally includes wherein the capturing mechanism further comprises a spring-loaded mechanism that is biased to maintain the collar in a closed configuration around the hub.

[0205] In Example 30, the subject matter of Example 29 optionally includes wherein the collar further comprises a window and is further configured to rotate about the hub, thereby aligning the window with any of the one or more retaining pockets of the hub.

[0206] Each of these non-limiting examples can stand on its own, or can be combined in various permutations or combinations with one or more of the other examples.Various Notes

[0207] The above detailed description includes references to the accompanying drawings, which form a part of the detailed description. The drawings show, by way of illustration, specific embodiments in which the invention can be practiced. These embodiments are also referred to herein as “examples.” Such examples can include elements in addition to those shown or described. However, the present inventor also contemplates examples in which only those elements shown or described are provided. Moreover, the present inventor also contemplates examples using any combination or permutation of those elements shown or described (or one or more aspects thereof), either with respect to a particular example (or one or more aspects thereof), or with respect to other examples (or one or more aspects thereof) shown or described herein.

[0208] In the event of inconsistent usages between this document and any documents so incorporated by reference, the usage in this document controls.

[0209] In this document, the terms “a” or “an” are used, as is common in patent documents, to include one or more than one, independent of any other instances or usages of “at least one” or “one or more.” In this document, the term “or” is used to refer to a nonexclusive or, such that “A or B” includes “A but not B,” “B but not A,” and “A and B,” unless otherwise indicated. In this document, the terms “including” and “in which” are used as the plain-English equivalents of the respective terms “comprising” and “wherein.” Also, in the following claims, the terms “including” and “comprising” are open-ended, that is, a system, device, article, composition, formulation, or process that includes elements in addition to those listed after such a term in a claim are still deemed to fall within the scope of that claim. Moreover, in the following claims, the terms “first,” “second,” and “third,” etc. are used merely as labels, and are not intended to impose numerical requirements on their objects.

[0210] The above description is intended to be illustrative, and not restrictive. For example, the above-described examples (or one or more aspects thereof) may be used in combination with each other. Other embodiments can be used, such as by one of ordinary skill in the art upon reviewing the above description. The Abstract is provided to comply with 37 C.F.R. § 1.72(b), to allow the reader to quickly ascertain the nature of the technical disclosure. It is submitted with the understanding that it will not be used to interpret or limit the scope or meaning of the claims. Also, in the above Detailed Description, various features may be grouped together to streamline the disclosure. This should not be interpreted as intending that an unclaimed disclosed feature is essential to any claim. Rather, inventive subject matter may lie in less than all features of a particular disclosed embodiment. Thus, the following claims are hereby incorporated into the Detailed Description as examples or embodiments, with each claim standing on its own as a separate embodiment, and it is contemplated that such embodiments can be combined with each other in various combinations or permutations. The scope of the invention should be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled.

Claims

THE CLAIMED INVENTION IS:

1. An extension device for radially collapsing a prosthetic heart valve device, comprising: a shaft comprising a first end and a second end opposite the first end; a support body axially aligned with and configured to provide support for the shaft; an actuation mechanism connected to the support body and configured to provide axial movement to the shaft; a grasping mechanism connected to the support body, the grasping mechanism configured to releasably capture a first portion of a prosthetic heart valve device; and a capturing mechanism connected to the shaft, wherein the capturing mechanism is configured to releasably capture a second portion of the prosthetic heart valve device; wherein the shaft is configured to move from a first retracted state whereby the prosthetic heart valve device can be radially uncollapsed when attached to the extension device, to a second extended state whereby the prosthetic heart valve device can be radially collapsed when attached to the extension device.

2. The extension device of claim 1, wherein the grasping mechanism comprises a grasping element connected to the support body, the grasping element configured to attach to the first portion of the prosthetic heart valve device with an attachment feature at a first end portion and attach to the support body at a second end portion.

3. The extension device of claim 2, wherein the grasping element is one of a plurality of grasping elements.

4. The extension device of claim 2, wherein the attachment feature comprises a hook rotatably connected to the support body.

5. The extension device of claim 4, further comprising a plurality of hooks.

6. The extension device of claim 1, wherein the capturing mechanism comprises a collar concentrically disposed around the shaft, the collar configured to translate along the shaft.

7. The extension device of claim 6, wherein the capturing mechanism further comprises a hub coupled to the shaft, wherein the collar is disposed about the hub.

8. The extension device of claim 7, wherein the hub includes a peg for engaging the second portion of the prosthetic heart valve device.

9. The extension device of claim 7, wherein the hub comprises a mandrel extending toward the grasping mechanism, the mandrel configured to influence a shape of the prosthetic heart valve device when radially collapsed.

10. The extension device of claim 9, further comprising a gripping handle connected to the shaft to hold the mandrel rotationally immobilized when grasped by a user.

11. The extension device of claim 7, wherein the collar is biased toward the grasping mechanism.

12. The extension device of claim 8, wherein the collar further comprises a notch disposed at a proximal edge of the collar, wherein the collar can be rotated to align the notch with the peg.

13. The extension device of claim 8, wherein the hub includes a pocket in which is located the peg.

14. The extension device of claim 1, wherein the actuation mechanism comprises: a threaded engagement between the shaft and the support body; and a wheel connected to the shaft to provide a rotational input.

15. The extension device of claim 1, wherein the actuation mechanism comprises: a sliding engagement between the shaft and the support body; and a biasing element to push the shaft distally.

16. The extension device of claim 15, wherein the actuation mechanism further comprises a cam lever configured to provide cam action, wherein the cam lever is configured to releasably lock the shaft into a locked position at an extent of the cam action.

17. The extension device of claim 15, wherein the actuation mechanism comprises a bolt action.

18. The extension device of claim 1, further comprising a retention sleeve disposed about the support body and configured to slide over the prosthetic heart valve device when the prosthetic heart valve device is attached to the extension device in a collapsed state.

19. The extension device of claim 1, wherein the support body further comprises a stand, wherein the stand is configured to position the support body in a horizontal configuration, wherein the stand comprises a detachable base.

20. A method of collapsing a radially expandable prosthetic heart valve device to a radially compressed state, the method comprising: loading the radially expandable prosthetic heart valve device onto a shaft of a stretching device; attaching a first end portion of the radially expandable prosthetic heart valve device to a capture mechanism on the shaft; attaching a second end portion of the radially expandable prosthetic heart valve device to a support structure for the shaft; and operating a stretching mechanism of the stretching device to radially collapsed and axially extend the radially expandable prosthetic heart valve device.

21. The method of claim 20, wherein loading the radially expandable prosthetic heart valve device onto the shaft of the stretching device comprises inserting the shaft into an annular expandable frame of the radially expandable prosthetic heart valve device.

22. The method of claim 21, wherein attaching the first end portion of the radially expandable prosthetic heart valve device to the support structure for the shaft comprises attaching pivotable hooks extending form the support structure to wires defining the annular expandable frame.

23. The method of claim 21, wherein attaching the second end portion of the radially expandable prosthetic heart valve device to the capture mechanism of the shaft comprises inserting pegs of the capture mechanism into holes of the annular expandable frame.

24. The method of claim 23, wherein attaching the second end portion of the radially expandable prosthetic heart valve device to the capture mechanism of the shaft comprises rotating a clasp to expose the pegs to receive the holes of the annular expandable frame.

25. The method of claim 23, wherein attaching the second end portion of the radially expandable prosthetic heart valve device to the capture mechanism of the shaft comprises translating a clasp to expose the pegs to receive the holes of the annular expandable frame.

26. The method of claim 20, wherein operating the stretching mechanism of the stretching device to radially collapsed and axially extend the radially expandable prosthetic heart valve device comprises turning a handwheel to rotate the shaft to operate a screw mechanism to move the capture mechanism away from the support structure.

27. The method of claim 26, further comprising grasping a gripping handle attached to the capture mechanism to prevent rotation of the capture mechanism relative to the shaft.

28. The method of claim 20, further comprising radially collapsing the radially expandable prosthetic heart valve device around a mandrel connected to the shaft to prevent radial infolding of the radially expandable prosthetic heart valve device.

29. The method of claim 20, further comprising sliding a retaining sleeve over the radially expandable prosthetic heart valve device when radially collapsed and axially extended.

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