Systems and methods for loading a medical device

Abstract

An assembly can include a delivery apparatus including a capsule including a removable distal end portion of the capsule and a main portion of the capsule. The distal end portion of the capsule can be defined by a plurality of perforations that extend around a circumference of the capsule. Other examples are included.

Description

Attorney Docket No: TMTTMT-24152WO01SYSTEMS AND METHODS FOR LOADING A MEDICAL DEVICECROSS REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of U.S. Provisional Application No. 63 / 760,844, filed February 20, 2025, which is incorporated herein by reference in its entirety.BACKGROUND

[0002] The human heart can suffer from a variety of valvular diseases. These valvular diseases can result in significant malfunctioning of the heart and ultimately require replacement of the native valve with an artificial valve. Percutaneous and minimally invasive surgical approaches may be used to deliver medical devices to locations inside the body that are not readily accessible by surgery or where access without surgery is desirable. For example, a prosthetic heart valve can be advanced through a patient’s vasculature to an implantation site in the heart and deployed to treat the heart. It can be challenging to easily and quickly crimp and load a medical device into a sheath / capsule of a delivery apparatus. There is a need for loading and crimping devices that better facilitate this process.SUMMARY

[0003] This summary is meant to provide some examples and is not intended to be limiting of the scope of the invention in any way. For example, any feature included in an example of this summary is not required by the claims, unless the claims explicitly recite the features. The features, components, steps, concepts, etc. described in examples in this summary and elsewhere in this disclosure can be combined in a variety of ways. Various features and steps as described elsewhere in this disclosure may be included in the examples summarized here.

[0004] In some implementations, various example systems, devices, apparatuses, methods, etc. for crimping and loading a medical device (e.g.. an implantable device, an implant, a replacement device, a repair device, a treatment device, a prosthetic device, a prosthetic valve, etc.) into a delivery apparatus or delivery system are described.

[0005] In some implementations, a system and / or an assembly can generally comprise a delivery apparatus or delivery system. In some implementations, the system / assembly can comprise a crimping device. In some implementations, the system / assembly can include a loading device. In some implementations, the system / assembly can comprise a treatment device or medical device (e.g., a valve treatment device, a replacement device, a repair device, an implantable medical device, an implant, a prosthetic valve, etc.).Attorney Docket No: TMTTMT-24152WO01

[0006] In some implementations, a delivery apparatus or delivery system for implanting one or more medical devices / treatment devices can generally comprise a first shaft and a second shaft disposed over the first shaft. In some implementations, the second shaft comprises a capsule in which the implantable medical device can be disposed.

[0007] In some implementations, a loading assembly can comprise a support tube. In some implementations, the loading assembly can comprise a funnel member.

[0008] In some implementations, the loading assembly can comprise one or more clamp members.

[0009] In some implementations, the loading assembly can comprise one or more of the other components and / or feature disclosed anywhere herein.

[0010] In some implementations, the capsule can comprise a plurality of perforations that extend around a circumference of the capsule. In some implementations, the plurality of perforations define a distal end portion of the capsule and / or a main portion of the capsule.

[0011] In some implementations, the capsule can comprise a removable strip of material that extends around a circumference of the capsule. In some implementations, the removeable strip of material defines a distal end portion of the capsule and / or a main portion of the capsule.

[0012] In some implementations, the capsule can be everted over itself during the loading process such that it comprises a first layer and a second layer. In some implementations, a method of loading a medical device can comprise everting the distal end portion of the capsule over itself prior to loading and unfolding the second layer after loading of the medical device.

[0013] In some implementations, the loading assembly can comprise a funnel member. In some implementations, a loading funnel can be disposed within the funnel member. A distal end portion of the capsule can be disposed between the funnel member and the loading funnel to hold the capsule in tension.

[0014] In some implementations, a distal tip of the capsule can comprise a marker band. In some implementations, the marker band can include one or more first engagement features. In some implementations, the support tube can comprise one or more second engagement features configured to engage the one or more first engagement features to hold the capsule in tension.

[0015] In some implementations, the loading assembly can comprise a clamp extension member comprising a main body and / or a clamp member. In some implementations, the main body extends substantially the length of the support tube when disposed thereon. In someAttorney Docket No: TMTTMT-24152WO01implementations, the main body of the clamp extension member provides circumferential compression along a length of the support tube.

[0016] In some implementations, the delivery apparatus can comprise a liner member. In some implementations, the liner member can be coupled to a retaining member. In some implementations, the liner member can comprise a material having lubricious characteristics.

[0017] In some implementations, prior to loading a medical device into the capsule, the liner member is everted over (or is adapted to be everted over) an outer surface of the capsule. In some implementations, as the medical device is advanced into the capsule the liner member is also advanced into the capsule thereby reducing friction between the medical device and the capsule.

[0018] In some implementations, a loading assembly can generally comprise a support tube configured to be disposed on a capsule of a delivery apparatus. In some implementations, a funnel member can be coupled to the support tube.

[0019] In some implementations, the holding assembly can further comprise a holder member configured to be disposed over a first end of the support tube to restrain the capsule against movement relative to the support tube.

[0020] In some implementations, the holder member can comprise an annular outer member defining a first central lumen. In some implementations, the first central lumen can be configured to taper from a first diameter at a first end portion to a second, smaller diameter at a second end portion.

[0021] In some implementations, the holder member can further comprise an annular inner member. In some implementations, a slit extends through a wall of the inner member and along a length of the inner member.

[0022] In some implementations, the inner member defines a second central lumen extending along the length of the inner member. In some implementations, the inner member and / or outer member are configured such that advancing the outer member over the inner member moves the inner member from a relaxed configuration, wherein the second central lumen has a first diameter, to a compressed configuration, wherein the second central lumen has a second, smaller diameter.

[0023] In some implementations, the holder member can comprise a main body defining a central lumen. In some implementations, the main body comprises a C-shape including a first end portion and a second end portion.

[0024] In some implementations, the loading assembly includes a locking member that comprises a first end and a second end. In some implementations, the first end of the lockingAttorney Docket No: TMTTMT-24152WO01member is pivotably coupled or coupleable to the first end portion of the main body. In some implementations, the second end of the locking member comprises an engagement feature. In some implementations, the locking member is pivotable between an unlocked configuration, wherein the engagement feature is not engaged, and a locked configuration, wherein the engagement feature engages a corresponding locking feature of the second end portion of the main body.

[0025] In some implementations, when the locking member is in the unlocked configuration the central lumen has a first diameter and wherein when the locking member is in the locked configuration the central lumen has a second diameter smaller than the first diameter.

[0026] In some implementations, any of the systems or assemblies herein can comprise one or more of the components recited in Examples 1-57 below.

[0027] Any of the above method(s) and any methods of using the systems, assemblies, apparatuses, devices, etc. herein can be performed on a living subject (e.g., human or other animal) or on a simulation (e.g., a cadaver, cadaver heart, imaginary person, simulator, etc.). With a simulation, the body parts can optionally be referred to as “simulated” (e.g., simulated heart, simulated tissue, etc.) and can optionally comprise computerized and / or physical representations.

[0028] Any of the above systems, assemblies, devices, apparatuses, components, etc. can be sterilized (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure they are safe for use with patients, and the methods herein can comprise (or additional methods comprise or consist of) sterilization of one or more systems, devices, apparatuses, components, etc. herein (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.).

[0029] This summary is provided to introduce a selection of concepts in a simplified form that are further described below in the detailed description. This summary is not intended to identify all key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter. The foregoing and other objects, features, and advantages of the disclosure will become more apparent from the following detailed description, claims, and accompanying figures.BRIEF DESCRIPTION OF THE DRAWINGS

[0030] FIG. 1 is a side elevation view of a medical device configured as a prosthetic heart valve, according to some implementations.Attorney Docket No: TMTTMT-24152WO01

[0031] FIG. 2 is a perspective view of a crimping device, according to some implementations, useable for crimping a medical device, such as the device shown in FIG. 1.

[0032] FIG. 3 is a side elevation view of a portion of a delivery apparatus that can be used with the device of FIG. 1, the crimping device of FIG. 2, and the loading assembly of FIG. 5, according to some implementations.

[0033] FIG. 4 is a cross-sectional side view of a distal end portion of a shaft of the delivery apparatus of FIG. 3 with the loading assembly of FIG. 5 disposed thereon.

[0034] FIG. 5 is an exploded perspective view of a loading assembly, according to some implementations.

[0035] FIGS. 6-11 show an example method of loading the device of FIG. 1 into delivery apparatus of FIG. 3 using the crimping device of FIG. 2 and the loading assembly of FIG. 5.

[0036] FIG. 12 illustrates a perspective view of a portion of a delivery apparatus, according to some implementations.

[0037] FIG. 13 illustrates a perspective view of a portion of a delivery apparatus, according to some implementations.

[0038] FIGS. 14-15 illustrate a perspective view of a portion of a delivery apparatus, according to some implementations.

[0039] FIG. 16 illustrates a cross-sectional view of a portion of a loading assembly, according to some implementations, disposed on a capsule of a delivery apparatus, according to some implementations.

[0040] FIG. 17 illustrates a cross-sectional view of a portion of the loading assembly of FIG.5 disposed on a capsule of a delivery apparatus, according to some implementations.

[0041] FIG. 18 illustrates an exploded view of a portion of a loading assembly, according to some implementations.

[0042] FIGS. 19-20 illustrate perspective views of the loading assembly of FIG. 18 being disposed on a capsule of a delivery apparatus.

[0043] FIGS. 21 A-21D illustrate a partially cross-sectional view of a method for loading a medical device into a capsule, according to some implementations.

[0044] FIG. 22 is a perspective view of a holder member, according to someimplementations.Attorney Docket No: TMTTMT-24152WO01

[0045] FIG. 23 is a cross-sectional view of the holder member of FIG. 22.

[0046] FIG. 24 is a top down view of the holder member of FIG. 22.

[0047] FIG. 25 is an exploded view of the holder member of FIG. 22.

[0048] FIG. 26 is cross-sectional view of the outer member of the holder member of FIG. 22.

[0049] FIG. 27 is a side elevational view of the inner member of the holder member of FIG.22.

[0050] FIG. 28 is a perspective view of a holder member, according to some implementations.

[0051] FIG. 29 is a cross-sectional view of the holder member of FIG. 28.

[0052] FIG. 30 is a side elevational view of the inner member of the holder member of FIG.28.

[0053] FIG. 31 is an exploded view of the holder member of FIG. 28.

[0054] FIG. 32 is a perspective view of a holder member, according to some implementations, shown in the locked configuration.

[0055] FIG. 33 is a top down, partial cross-sectional view of the holder member of FIG. 32, shown in the locked configuration.

[0056] FIG. 34 is a perspective view of the holder member of FIG. 32, shown in the unlocked configuration.DETAILED DESCRIPTION

[0057] For purposes of this description, certain aspects, advantages, and novel features of the examples of this disclosure are described herein. The disclosed methods, apparatus, and systems should not be construed as being limiting in any way. Instead, the present disclosure is directed toward all novel and nonobvious features and aspects of the various disclosed examples, alone and in various combinations and sub-combinations with one another. The methods, apparatus, and systems are not limited to any specific aspect or feature or combination thereof, nor do the disclosed examples require that any one or more specific advantages be present or problems be solved.

[0058] Although the operations of some of the disclosed examples are described in a particular, sequential order for convenient presentation, it should be understood that thisAttorney Docket No: TMTTMT-24152WO01manner of description encompasses rearrangement, unless a particular ordering is required by specific language set forth below. For example, operations described sequentially may in some cases be rearranged or performed concurrently. Moreover, for the sake of simplicity, the attached figures may not show the various ways in which the disclosed methods can be used in conjunction with other methods. Additionally, the description sometimes uses terms like “provide” or “achieve” to describe the disclosed methods. These terms are high-level abstractions of the actual operations that are performed. The actual operations that correspond to these terms may vary depending on the particular implementation and are readily discernible by one of ordinary skill in the art.

[0059] All features described herein are independent of one another and, except where structurally impossible, can be used in combination with any other feature described herein. For example, the liner member 450 as shown in FIGS. 21A-21D can be used in combination with any of the loading assemblies and / or capsules disclosed herein. Any of the disclosed delivery apparatuses can be used in combination with the loading assembly 300 and / or crimping device 200.

[0060] As used in this application and in the claims, the singular forms “a,” “an,” and “the” include the plural forms unless the context clearly dictates otherwise. Additionally, the term “includes” means “comprises.” Further, the term “coupled” generally means physically, mechanically, chemically, magnetically, and / or electrically coupled or linked and does not exclude the presence of intermediate elements between the coupled or associated items absent specific contrary language. As used herein, the term “and / or” used between the last two of a list of elements means any one or more of the listed elements. For example, the phrase “A, B, and / or C” means “A”, “B,”, “C”, “A and B”, “A and C”, “B and C”, or “A, B, and C.”

[0061] As used herein, the term “proximal” refers to a position, direction, or portion of a device that is closer to the user and further away from the implantation site. As used herein, the term “distal” refers to a position, direction, or portion of a device that is further away from the user and closer to the implantation site. Thus, for example, proximal motion of a device is motion of the device away from the implantation site and toward the user (e.g., out of the patient’s body), while distal motion of the device is motion of the device away from the user and toward the implantation site (e.g., into the patient’s body). The terms “longitudinal” and “axial” refer to an axis extending in the proximal and distal directions, unless otherwise expressly defined.Attorney Docket No: TMTTMT-24152WO01

[0062] In some implementations, a medical device or stent or support structure thereof can be crimped or loaded onto / into a delivery system by driving it through a cone-like surface, which compresses the stent / structure to a smaller diameter. For example, a static conical tube can be passed over a stent, thereby reducing its diameter. This method can be used for crimping prosthetic valves having self-expanding metal frames (e.g., frames made of Nitinol), which are easily deformable. Self-expandable prosthetic valves can be pushed from the conical tube of the loading / crimping device into a sheath of a delivery apparatus, which retains the prosthetic valve in a radially compressed state.

[0063] In some implementations, an example crimping method uses crimping jaws to create a cylinder-like surface that can change diameter. This method can be used for crimping prosthetic valves having plastically expandable frames (e.g., frames made of stainless steel or cobalt chromium alloys).

[0064] In some implementations, self-expandable devices herein (e.g., prosthetic valves, replacement devices, repair devices, treatment devices, implants, etc.) can have multiple connection features extending from the frame that can form a releasable connection with the distal end of a delivery apparatus. Once the device has been deployed from the sheath inside a subject's body, the physician can release the connection between the delivery apparatus and the connection features of the device. A challenge in crimping self-expandable devices involves the ability of the physician to easily and quickly crimp and load a device into a sheath / capsule of a delivery apparatus while aligning and connecting the connection features of the device with mating connection features of the delivery apparatus and while preventing folding or bunching of the capsule.

[0065] FIGS. 1-12 show an example system for at least partially crimping a prosthetic valve and / or other compressible, medical devices, such as stents, grafts, treatment devices, implants, repair devices, etc., e.g., using a crimping device, and for loading said medical device into a delivery apparatus, e.g., using a loading assembly. Though the following description refers to a prosthetic heart valve, it should be understood that the devices and methods described herein can be applied to any compressible medical device that is loaded into a shaft / catheter / tube / capsule / etc.

[0066] The illustrated system generally comprises a compressible, medical device (e.g., an implantable device, an implant, a replacement device, a repair device, a treatment device, a prosthetic device, a prosthetic valve, etc.), such as prosthetic heart valve 100 shown in FIG.Attorney Docket No: TMTTMT-24152WO011, a crimping device, such as crimping device 200 shown in FIG. 2, a loading assembly, such as loading assembly 300 shown in FIGS. 4-5, and a delivery apparatus, such as delivery apparatus 400, a portion of which is shown in FIG. 3. The crimping device 200 is configured to reduce the diameter of the prosthetic valve 100 from a fully expanded configuration to a fully or partially radially compressed state for initial coupling with a delivery apparatus, such as delivery apparatus 400. Once the prosthetic valve 100 has been coupled to the delivery apparatus 400, the loading assembly 300 (FIGS. 4-5) can be used to fully crimp the prosthetic valve 100 and / or load it into a sheath or capsule 402 of the delivery apparatus 400.

[0067] FIG. 1 illustrates a medical device 100 configured, for illustrative purposes, as a prosthetic valve. The prosthetic valve 100 can be radially collapsible and expandable between an expanded configuration and a delivery configuration (or any of various configurations in between). The prosthetic valve 100 can be self-expandable or plastically expandable. In some implementations, a self-expandable valve can have a frame formed from a selfexpanding metal (e.g., Nitinol). In some implementations, a plastically expandable valve can have a frame formed from a plastically deformable metal (e.g., stainless steel or cobalt chromium alloy).

[0068] Though the prosthetic valves shown herein are described as plastically deformable or self-expandable prosthetic valves, it should be noted that the crimping devices and loading assemblies disclosed herein can be used with any type of compressible implantable device. For example, the crimping devices and loading assemblies can be used with mechanically-expandable prosthetic heart valves in which the frame is radially expandable via one or more mechanical actuators (such as the prosthetic valves described in U.S. Patent No. 10,603,165 and U.S. Publication No. 2023 / 0225863, each of which is incorporated herein by reference in its entirety). The frames of some mechanical valves can comprise pivotable junctions between the struts of the frame, while others can comprise a unitary lattice frame expandable and / or compressible via mechanical means. The crimping devices and loading assemblies described herein can additionally be used with other types of compressible medical devices, such as other transcatheter prosthetic valves, including balloon-expandable prosthetic heart valves in which the frame is made from a plastically deformable material such as is disclosed in U.S. Patent Nos., 9,393,110 and 11,096,781, and U.S. Publication No. 2019 / 0365530, each of which is incorporated herein by reference in its entirety.

[0069] FIG. 1 is a side elevation view of an example medical device 100, depicted for illustrative purposes as a prosthetic valve, that can be crimped using any of the crimpingAttorney Docket No: TMTTMT-24152WO01devices disclosed herein. The prosthetic valve 100 comprises a radially expandable and compressible metal frame 102 supporting a plurality of leaflets 104 inside of the frame. In some implementations, the frame 102 can comprise an inner frame portion and an outer frame portion. In some implementations, the prosthetic valve 100 can also include a sealing member 106 (e.g., a fabric skirt) secured on the outside of the frame 102 and configured to create a seal against a native valve annulus. In some implementations, the prosthetic valve 100 is self-expandable with the frame 102 being formed from a self-expanding metal (e.g., Nitinol). In some implementations, as mentioned previously, the prosthetic valve 100 can be balloon-expandable or mechanically expandable.

[0070] The frame 102 can comprise a main body 103 and a first set of anchors 108. In some implementations, the frame can comprise a second set of anchors 110. In some implementations, the second set of anchors 110 can extend toward the first set of anchors. In some implementations, the first set of anchors and the second set of anchors each extend from opposing portions of the main body 103 toward each other.

[0071] In some implementations, the prosthetic valve 100 can be a prosthetic mitral valve. In some implementations, the first anchors 108 are part of an atrial portion of the valve and configured to help anchor the prosthetic valve 100 in the left atrium. In some implementations, the second anchors 110 are part of a ventricular portion of the valve and are configured to help anchor the prosthetic valve 100 in the left ventricle.

[0072] In some implementations, the second anchors 110 can be disposed between a plurality of apices 113 of the frame 102. In some implementations, the end of the frame 102 opposite the second anchors 110 can include a plurality of connecting arms 112 having enlarged end portions 114. In some implementations, the end portions 114 are configured to engage mating features of a delivery apparatus to form a releasable connection between the prosthetic valve and the delivery apparatus. Further details of the prosthetic valve can be found, for example, in U.S. Patent No. 10,639,143, which is incorporated by reference herein in its entirety.

[0073] FIG. 2 illustrates an implementation of a crimping device 200. As mentioned, the crimping device 200 is configured to reduce the diameter of a medical device 100 (which can be configured as above or as a variety of other types of medical devices) from a fully expanded configuration to a fully or partially radially compressed state for initial coupling with a delivery apparatus.Attorney Docket No: TMTTMT-24152WO01

[0074] In some implementations, the crimping device 200 can generally comprise a housing 202 and / or an actuator 204. In some implementations, the crimping device 200 can further comprise a valve holder or pusher member 206 (which can also be referred to as a pedestal member). In some implementations, the valve holder or pusher member 206 can be removably coupled to the actuator 204. In some implementations, the actuator 204 and pusher member 206 can be axially movable relative to the housing 202.

[0075] In some implementations such as shown in FIG. 2, the housing 202 can comprise first and second housing members or side portions 202a, 202b that are separable from one another, and in some implementations the housing 202 can be formed as a unitary piece.

[0076] As shown in FIG. 2, the housing 202 can comprise a distal or inlet end portion 208 comprising an aperture or inlet 210 and a proximal or outlet end portion 212 comprising an aperture or outlet 214. In some implementations, the housing 202 can have a generally cylindrical shape.

[0077] In some implementations, the housing 202 can comprise an inner bore defining a tapered or funnel segment 216 that tapers in a direction from the inlet 210 to the outlet 214. In some implementations, the inner bore and / or the funnel segment 216 terminates at the outlet. In some implementations, the funnel segment 216 can be defined by a plurality of rib members 218 extending inwardly from an interior surface of the housing. In some implementations, the funnel segment 216 can taper from a first, greater diameter adjacent the inlet 210 to a second, smaller diameter adjacent the outlet 214. In some implementations, the diameter of the outlet 214 can be approximately the specified diameter of the device 100 in the radially compressed, delivery configuration.

[0078] In some implementations, the first and second side portions 202a, 202b can be held or locked together in the assembled state while a prosthetic valve is being crimped and then separated from each other to facilitate removal of the crimping device 200 from the delivery apparatus 400 after the prosthetic valve is loaded onto the delivery apparatus. As shown in FIG. 2, the first and second side members 202a, 202b can be releasably retained together using a plurality of engagement elements 220, each of which includes a first engagement member 220a coupled to the first side portion 202a and a second engagement member 220b coupled to the second side portion 202b. In some implementations, the first and second engagement members 220a, 220b can releasably engage one another to prevent separation of the first and second side portions 202a, 202b.Attorney Docket No: TMTTMT-24152WO01

[0079] As mentioned, the crimping device 200 can further comprise a valve holder or pusher member 206 that is releasably couplable to the actuator 204. In some implementations, the pusher member 206 can be coupled to the actuator 204 such that the actuator 204 can rotate relative to the pusher member 206.

[0080] Referring still to FIG. 2, in some implementations, the pusher member 206 can comprise a generally cylindrical or tubular main body or stem 222 including an inner bore, and a holding portion 224 comprising a plurality of circumferentially spaced, radially extending members referred to herein as arms 226. In some implementations, the arms 226 can be configured to be slidably disposed between the ribs 218 of the funnel segment 216, such that as the pusher member 206 moves axially with respect to the housing 202, the arms 226 travel and / or slide through gaps / slots defined between the ribs 218.

[0081] In some implementations, the inlet end portion 208 of the housing 202 can comprise a threaded surface 228 (e.g., an inner surface, etc.) disposed adjacent the funnel 216. The actuator 204 can comprise a correspondingly threaded surface 230 (e.g., an outer surface, etc.) configured to interface with the threaded surface 228 of the housing 202.

[0082] Further details of the crimping device, including details of the housing, engagement elements, actuator, pusher member, and alternative configurations thereof, can be found, at least, in International Publication No. W02023 / 076103, which is incorporated by reference herein in its entirety.

[0083] As mentioned, the system can further comprise a delivery apparatus 400 or a portion thereof. FIG. 3 illustrates a portion of an example delivery apparatus 400 having a nosecone / tapered tip 404, a first shaft 406 configured as a guidewire lumen, a guidewire shield 408, a valve retaining member 410, a tubular retaining member referred to hereinafter as an outer ring 412 (which can be disposed on its own shaft), and an outer shaft 414 (a distal end portion of which comprises capsule 402 which has a plurality of tabs 416). As shown in FIG. 3, the valve retaining member 410 can comprise a plurality of circumferentially spaced slots sized to receive the connecting arms 112 of the device 100. Further details and / or features that can be incorporated into and / or used with a delivery apparatus herein can be found, at least, in U.S. Patent No. 10,813,757, U.S. Publication No. 2019 / 0008640, International Publication No. WO 2023 / 076103, and International Publication No. WO 2022 / 174057, each of which is incorporated by reference herein in its entirety.Attorney Docket No: TMTTMT-24152WO01

[0084] Referring to FIGS. 4-5, the system can further comprise a loading assembly 300, as mentioned previously. In some implementations, the loading assembly 300 can be configured to be disposed over a portion of a delivery apparatus, such as delivery apparatus 400 described previously, and can be configured to fully crimp a compressible medical device, such as device 100 described previously, and / or load it into a capsule or sheath of the delivery apparatus.

[0085] FIG. 5 illustrates an exploded view of the loading assembly 300, which can generally comprise a support tube 302, a loader member / funnel member 304, one or more fasteners / clamps 306, and an annular tab ring / holder member 308. In some implementations, the support tube 302 can be configured to support the sheath / capsule 402 of the delivery apparatus 400 such that it remains in tension and does not crumple or fold during the loading of the medical device. In some implementations, the loading assembly 300 or components thereof can be configured to separate into pieces or open, e.g., like a clam shell, such that the loading assembly 300 can be placed or assembled on and removed from the delivery apparatus 400.

[0086] In some implementations, the support tube 302 can comprise a first lateral side portion 302a and a second lateral side portion 302b. In some implementations, each side portion 302a, 302b can comprise a half-cylinder such that when they are placed together they form a generally cylindrical or tubular shape defining an inner bore 310 (FIG. 4). In some implementations, the side portions 302a, 302b can each include mating features (e.g., one or more tabs and corresponding recesses) that assist with coupling the side portions to one another.

[0087] In some implementations, the support tube 302 can comprise a single portion instead of the first lateral side portion 302a and the second lateral side portion 302b. In some implementations, the single portion can include a side slit or channel that allows the support to snap sideways over the capsule.

[0088] In some implementations, the support tube 302 can comprise a first or inlet end portion 312, and a second end portion 314. In use, the first and second side portions 302a, 302b can be placed over a shaft of a delivery apparatus (e.g., shaft 414) and then can be held or locked together using a first clamp 306a. In some implementations, the side portions 302a, 302b can be held in the assembled state while a prosthetic valve (e.g., prosthetic valve 100) is crimped and loaded into a capsule or sheath 402 of the delivery device, and then can beAttorney Docket No: TMTTMT-24152WO01separated from each other to facilitate removal of the loading assembly 300 from the delivery apparatus after the prosthetic valve has been loaded.

[0089] Referring to FIG. 5, each clamp 306 can be a C-shaped member configured to be disposed over an end portion of the support tube 302 in order to hold the first and second portions 302a, 302b of the support tube together. In some implementations, each clamp 306 can comprise one or more tabs 316 extending radially outwardly from an outer surface of the clamp 306. In some implementations, force can be applied to the tabs 316 (e.g., manually by a user) to advance the clamp 306 over a portion of the support tube 302 and / or other component of the loading assembly 300.

[0090] In some implementations, a first clamp member 306a can be used to hold or lock the second end portion 314 of the support tube 302 in the assembled position by axially advancing the clamp 306a over the second end portion. In some implementations, a second clamp 306b can be disposed over the inlet end portion 312 of the support tube 302 and the funnel member 304 to couple the funnel member 304 to the support tube 302 and retain the inlet end portion 312 of the support tube 302 in the assembled position.

[0091] As mentioned previously, the loading assembly 300 can comprise a holder member 308. The holder member 308 can be an annular member sized to fit over the inlet end portion 312 of the support tube 302. As shown in FIG. 4, when the support tube 302 is disposed over a capsule / sheath 402 of the delivery system, the holder member 308 can retain one or more tabs 416 of the capsule 402 in a folded-back position. The tabs 416 can be defined by circumferentially spaced-apart, axially extending cuts formed along the distal end portion of the capsule 402. In some implementations, the tabs 416 can be folded back over the capsule to facilitate insertion of the implant into the capsule and bending of the distal end portion. Further details of the capsule can be found, at least, in U.S. Patent No. 10,813,757, which is incorporated by reference herein in its entirety.

[0092] In some implementations, the holder member 308 can advantageously hold the tabs 416 of the capsule 402 in tension to keep the capsule taut, thereby preventing or mitigating bending or deformation of the capsule during the insertion / loading of the prosthetic valve 100. In some implementations, the holder member 308 further functions to help retain the side portions 302a, 302b of the support tube 302 in the assembled position.

[0093] In some implementations, the capsule 402 can be formed from one or more materials such as PTFE, ePTFE, polyether block amide (Pebax®), polyetherimide (Ultem®), PEEK,Attorney Docket No: TMTTMT-24152WO01urethane, Nitinol, stainless steel, and / or any other biocompatible material. In some implementations, the capsule can comprise an outer polymer layer, a metal middle layer located on a radially inner surface of the outer polymer layer, and an inner liner located on a radially inner surface of the middle layer.

[0094] In some implementations, the funnel member 304 can comprise a body portion 318 and a funnel portion 320. In some implementations, the funnel member 304 can comprise first and second side portions 304a, 304b, that when assembled together form the funnel member 304 and define an inner bore extending along the length of the funnel member. As shown in FIG. 4, the funnel portion 304 can comprise an inlet end portion 322 and an outlet end portion 324 and can taper from a first diameter DI at the inlet end portion 322 to a second, smaller diameter D2 at the outlet end portion 324. When assembled on the support tube 302, the outlet 324 of the funnel member 304 can be positioned adjacent (e.g., distally of) the capsule 402 and in communication with the interior of the capsule 402, as shown in FIG. 4. The second clamp member 306b can be used to hold or lock the side portions 2460 of the funnel member 2404 in the assembled position, as shown in FIG.4.

[0095] Further details of the loading assembly, including its assembly onto the capsule, can be found, at least, in International Publication No. W02023076103A1, which is incorporated by reference herein in its entirety.

[0096] Referring now to FIGS. 6-11, in some implementations, the system can be used to crimp a compressible medical device, such as device 100 described herein, and load the medical device into a delivery apparatus in the following example manner. Though the following method is described with reference to a prosthetic heart valve and a delivery apparatus, it should be understood that this method of loading can be used with any type of compressible medical device, e.g., to load such a device into a shaft / capsule / sheath etc.

[0097] Referring to FIG. 6, the prosthetic valve 100 can be disposed on the pusher member 206 such that the second anchors 110 are disposed within seats 232 of the arms 226. The pusher member 206 optionally can be removably coupled to the actuator 204.

[0098] Referring to FIG. 7 (the actuator 204 is not shown in FIGS. 7-9 for purposes of illustration), the housing 202 of the crimping device 200 can then be disposed over the first shaft 406 such that it is disposed at least partially over the prosthetic valve 100 and / or the valve retaining member 410. The housing 202 can be disposed such that the arms 226 of theAttorney Docket No: TMTTMT-24152WO01pusher member 206 (and thus the second anchors 110 of the prosthetic valve 100) are positioned between the ribs of the inner funnel segment 218 (FIG. 2).

[0099] As described previously, an inner surface of the housing 202 can comprise a threaded portion 228 (FIG. 2) configured to interface with the threaded portion 230 of the actuator 204 (FIG. 2). In some implementations, once the housing 202 is disposed on the first shaft 406, the pusher member 206 can be inserted into the housing 202 until the threads 230 of the actuator 204 engage the threads 228 of the housing 202. Thus engaged, the actuator 204 can be rotated and the threaded portions can translate the rotation into axial movement (e.g., pushing) of the pusher member 206, allowing the pusher member to advance axially forward into the housing thereby pushing prosthetic valve 100 through the housing 202. As the prosthetic valve 100 is pushed through the funnel segment 216, the prosthetic valve 100 is radially compressed and pushed toward the outlet 214.

[0100] In some implementations, threads 230 of the actuator 204 can be external, while the threads 228 of the housing 202 are internal. In some implementations, threads 230 of the actuator 204 can be internal, while the threads 228 of the housing 202 are external.

[0101] In some implementations, as the prosthetic valve 100 is advanced through the funnel segment 216, the ribs 218 of the funnel segment guide the enlarged end portions 114 of the frame 102 into the corresponding openings in the valve retaining member 410, as shown in FIG. 8. The coupled valve retaining member 410 and prosthetic valve 100 can then be partially advanced through the outlet 214.

[0102] In some implementations, the loading assembly 300 can be assembled (or in some cases partially assembled) on the delivery apparatus 400 prior to the initial crimping using the crimping device 200, concurrently with the initial crimping, or after the initial crimping. In some implementations, the side portions 302a, 302b of the support tube 302 can be disposed over the capsule 402 and the first clamp 306a can be advanced over the second end portion of the support tube 302 to retain the support tube 302 in the assembled position.

[0103] In some implementations, the capsule 402 can be advanced (e.g., using the handle of the delivery apparatus 400) until it contacts the crimping device 200, and the prosthetic valve 100 can be slowly drawn out from the crimping device 200. In some implementations, the capsule 402 can then be retracted (e.g., using the handle of the delivery apparatus) to ensure that the prosthetic valve 100 is properly coupled with the valve retaining member 410 while the actuator 204 of the crimping device 200 is held in place.Attorney Docket No: TMTTMT-24152WO01

[0104] As shown in FIG. 9, with the amis 112 of the prosthetic valve coupled to the retaining member 410, the outer ring 412 can be advanced (e.g., using the handle of the delivery apparatus) over the valve retaining member 410 and a portion of the prosthetic valve 100 within the valve retaining member 410 (e.g., the arms 112 with enlarged end portions 114) to retain the enlarged end portions 114 within the valve retaining member 410 when the crimping device 200 is removed from the first shaft 406. Thereafter, crimping device 200 can be removed from the prosthetic valve and the delivery apparatus.

[0105] Referring to FIG. 10, the loading assembly 300 can then be advanced (e.g., slid) over the outer ring 412. In some implementations, the capsule 400 (and therefore the attached loading assembly 300) can be advanced over the prosthetic valve 100 using the handle of the delivery apparatus 400 (or the prosthetic valve 100 can be retracted into the assembled capsule and loading assembly). In some implementations, as the loading assembly 300 is advanced over the prosthetic valve 100, the funnel portion 304 radially compresses the prosthetic valve 100, allowing the prosthetic valve to be loaded into the capsule 402 (within the support tube 302). In some implementations, as the capsule 402 and loading assembly 300 advance over the prosthetic valve 100, the anchors 110 of the prosthetic valve 100 can contact and be inverted by the funnel member 304 such that the prosthetic valve 100 moves into a substantially straightened configuration wherein the anchors 110 extend distally from the main body 103 and are rotated approximately 180 degrees from their unrestrained configuration.

[0106] With the tab members 416 (see e.g., FIG. 4) of the capsule 402 folded back proximally over the capsule 402 and held in place by the holder member 308, the distal end portion of the capsule 402 can remain taut as the prosthetic valve 100 is inserted into the capsule. See, for example, FIG. 4 which shows a cross-sectional view of the assembled loader assembly 300 disposed on the capsule 402. This prevents the capsule from bunching or buckling during the loading process. The support tube 302 can also provide additional structural support to the capsule 402.

[0107] As shown in FIG. 11, once the prosthetic valve 100 has been fully received within the capsule 402, the loading assembly 300 can be removed from the delivery apparatus 400 (e.g., by removing the first and second clamps 306a, 306b, and removing the side portions of the funnel member 304 and the support tube 302). Once the prosthetic valve 100 has been fully loaded in the capsule 402, the tabs 416 can be removed from the capsule 402, e.g., using a tab cutting method. Tabs 416 thus removed, the nosecone 404 (FIG. 10) can be retractedAttorney Docket No: TMTTMT-24152WO01proximally toward the capsule 402 until a proximal edge of the nose cone abuts the distal edge of the capsule 402, closing the prosthetic valve 100 within the capsule.

[0108] Referring to FIG. 12, in some implementations, the capsule 402 can comprise perforations 418 configured to allow the tabs 416 to be more easily removed from the capsule 402. For example, the perforations 416 can comprise a plurality of openings that are disposed about the circumference of the capsule 402 and that extend radially through the wall of the capsule. In some implementations, the perforations 416 are arranged in a circumferentially extending row of perforations. The perforations 418 can direct a user to the axial location along the capsule 402 where it is desired to cut to remove the tabs 416. The user can then use a cutting implement (e.g., a scalpel) to remove the tabs 416 by cutting along the perforations. For example, the user can align a cutting edge of the cutting implement with the perforations 418 and advance the cutting edge radially inwardly toward a longitudinal axis of the capsule 402. The user can then rotate the capsule 402 relative to the cutting implement (or vice versa) while applying cutting pressure in order to cut along the perforations 418.

[0109] Such a configuration advantageously marks the desired cutting location (thereby ensuring that a user does not cut in the wrong location and inadvertently damage the capsule or medical device) and the perforations 418 ensure that there is less capsule material to cut through, which facilitates the cutting process and mitigates the need for the user to go back and make corrections. The perforations 418 can further ensure that the cut line (and therefore the distal edge of the capsule 402 once the tabs 416 are removed) is straight, which can aid in positioning the distal edge of the capsule such that it abuts a proximal edge 420 of the nose cone 404.

[0110] In some implementations, the perforations 418 can be configured such that a user can tear the tabs 416 off of the capsule 402 along the perforations 418 without the need to use a cutting implement.

[0111] In some implementations, in lieu of perforations 418, the capsule 402 can comprise an indentation line that indicates to the user where to cut with the cutting implement but does not comprise openings that extend through the wall of the capsule 402.

[0112] Referring to FIG. 13, in some implementations, the capsule 402 can comprise a removable strip 422 comprising a first edge 424, a second edge 426, and a pull tab 428. In some implementations, the removable strip 422 can extend at least 360-degrees around the circumference of the capsule 402. The removable strip 422 can be disposed between the tabsAttorney Docket No: TMTTMT-24152WO01416 and the location that will be the distal edge of the capsule 402 when the tabs are removed. To remove the tabs 416 a user can grip the pull-tab 428 and apply a force radially outwardly away from a longitudinal axis of the capsule 402 while also circumnavigating the exterior surface of the capsule 402. When pulled away from the capsule, the removable strip 422 can be configured to tear away from the capsule 402 and tabs 416 along the first and second edges 424, 426, thereby separating the tabs 416 from the capsule 402 and forming a distal edge of the capsule 402 at the location of the removed strip 422. The removable strip 422 can thereby be removed from the capsule 402 and the tabs 416 can likewise be removed.

[0113] In some implementations, the removable strip 422 can be in the form of an annular strip with edge 424 forming a frangible connection with the tabs 416 or a section of the capsule 402 distal to the strip and from which the tabs 416 extend and with the edge 426 forming a frangible connection with the section of the capsule 402 proximal to the strip. In some implementations, the removable strip 422 can be perforated along the first edge 424 and the second edge 426. In some implementations, the removable strip 422 can comprise a reinforcing member (e.g., a wire) configured to provide additional support to the removable strip and / or serve as the pull-tab 428 or gripping surface for the user. In some implementations, the reinforcing member can be adhesively coupled to the removable strip 422 or embedded within the removable strip 422. In some implementations, the pull-tab 428 can be a portion of the removable strip 422 that has been torn away from the capsule 402. In some implementations, the pull-tab 428 can comprise a looped portion of the reinforcing member.

[0114] Referring to FIGS. 14-15, in some implementations, in lieu of capsule 402 including tabs 416, the delivery apparatus can comprise a capsule 502 which does not include tabs. In some implementations, a distal end portion 504 of the capsule 502 can be everted or folded back over a main body 506 of the capsule 502 such that the main body 506 forms a first layer and the distal end portion 504 forms a second layer disposed over the first layer, as shown in FIG. 14. In some implementations, the second layer 504 provides additional support for the capsule 502 during loading of the medical device by providing circumferential compression along the first layer 506 to increase rigidity of the capsule 502.

[0115] In some implementations, as the radially compressed medical device, such as device 100 described previously, is advanced into the capsule 502 (or the capsule 502 is advanced over the medical device) the second layer 504 can slowly be unfolded and advanced over the top of the compressed device (e.g., the prosthetic valve 100). In some implementations, theAttorney Docket No: TMTTMT-24152WO01medical device can be loaded into the capsule 502, for example, using the loading assembly 300 described and / or the method described above and shown in FIGS. 6-11. During the loading process, in some implementations, the folded distal end portion 504 can be positioned between the holder member 308 and the distal end portion of the support tube 310 (similar to the flaps 416 in FIG. 4).

[0116] Referring now to FIG. 16, in some implementations, in lieu of a capsule 402 including tabs 416, the delivery apparatus can comprise a capsule 602 which does not include tabs. In some implementations, the loading assembly 300 can comprise an additional funnel member, referred to as the loading funnel 326.

[0117] As shown in FIG. 16, which depicts a cross-sectional view of the loading assembly 300 disposed on the capsule 602 of the delivery apparatus, the loading funnel 326 can be configured to be disposed within the inlet end portion 328 of the existing funnel member 304 and, in some implementations, can extend at least partially into the inlet end 312 of the support tube 302. Rather than folding the capsule 602 over an inlet end of the support tube 302 and securing the tabs with the holder member 308 (such as shown in FIG. 4 but which is not included in FIG. 16), in the implementation shown in FIG. 16, the tabless leading end 604 of the capsule 602 is captured radially between the inlet end 312 of the support tube 302 and / or the funnel member 304 on outside of the capsule 602 and the loading funnel 326 on the inside of the capsule 602. In this manner, the distal end portion 604 of the capsule can be pinched between the loading funnel 326 on the inside of the distal end portion 604 and the funnel member 304 and / or the support tune 302 on the outside of the distal end portion 604. This maintains the capsule 602 in a tensioned or taut state during loading of the medical device and prevents the capsule 602 from buckling or bunching during loading. In some implementations, the distal end portion 604 of the capsule can be slightly enlarged or dilated in diameter during the loading process by the loading funnel 326 to facilitate insertion of the prosthetic valve into the capsule 602.

[0118] In some implementations, the loading funnel 326 can be retained within the inlet end 312 of the support tube 302 using an interference fit or friction fit. In some implementations, the loading funnel 326 can be coupled to the support tube 302 and / or the funnel member 304 via other mechanical means, such as threads or a detent.

[0119] In some implementations, the existing components of the loading assembly 300 can be adapted to function in this manner. For example, rather than use a separate funnel memberAttorney Docket No: TMTTMT-24152WO01304, the support tube 302 can be configured to include a flared funnel end portion at the inlet end 312. In some implementations, the loading funnel 326 can be disposed within flared the inlet end portion of the combined support tube / funnel member. In some implementations, the support tube 302 comprises a flared funnel end portion that is adapted to extend over the loading funnel 326 and the funnel member 304 is not used. In some implementations, the clamp 306a can be optional.

[0120] Referring to FIG. 17, in some implementations, in lieu of capsule 402 including tabs 416, the delivery apparatus can comprise a capsule 702 which does not include tabs. In some implementations, a leading (distal) end portion 704 of the capsule 702 can include engagement features 708 for engaging corresponding engagement features 332 of the support tube 302. In some implementations, the distal end portion 704 optionally can comprise a marker band 706. The marker band 706 can comprise, for example, a radiopaque marker, such as a radiopaque band or ring embedded in a polymer material forming the distal end portion 704 of the capsule. In some implementations, the marker band 706 is position at the distal end of the prosthetic valve contained within the capsule 702 during delivery to an implantation site. In some implementations, the radiopaque marker optionally can be secured to or located at a commissure of the prosthetic heart valve to allow for visualization of the commissure under imaging (for example, fluoroscopy) during the implantation procedure.

[0121] As noted above, the distal end portion 704 of the capsule can comprise one or more first engagement features 708 configured (e.g., sized and shaped) to engage corresponding second engagement features 332 on an inner surface of the support tube 302 of the loading assembly 300. This configuration allows the support tube 302 to couple the capsule 702 and retain the capsule 702 in a tensioned or taut state during loading of the medical device and prevents the capsule from buckling or bunching during loading.

[0122] In some implementations, the first engagement features 708 can be grooves / recesses / openings extending radially inwardly toward a longitudinal axis of the capsule 702, and the second engagement features 332 can be protrusions / projections / members extending from an inner surface of the support tube 302 such that they can be disposed within the first engagement features 708 as shown in FIG. 17. In some implementations, the recesses can be disposed on the support tube 302 and the projections on the capsule 702. The first and second engagement features 708, 332 can have corresponding shapes such that the second engagement features can extend into the first engagement features or vice versa. In some implementations, the second engagement featuresAttorney Docket No: TMTTMT-24152WO01332 can have a circular shape in cross-section. In some implementations, the second engagement features 332 can have any of various shapes in cross-section, for example, triangular, semi-circular, square, rectangular, linear, oval, square oval, etc.

[0123] In some implementations, one or more of the components of the loading assembly 300 previously described can be used with the support tube 302 having the engagement features 332.

[0124] Referring to FIG. 18, in some implementations, in lieu of capsule 402 including tabs 416, the delivery apparatus can comprise a capsule which does not include tabs. In some implementations, in lieu of the support tube 302, first clamp 306a, and holder member 308, the loading assembly 300 can comprise a support tube 802, a clamp extension member 806, and a holder member 808. The other components of the loading assembly 300 can remain the same, including funnel member 304 and second clamp 306b. The clamp extension member 806 can comprises a main body 810 that extends substantially the entire length of the support tube 802 when disposed thereon.

[0125] In some implementations, the support tube 802 can be the same as support tube 302 described previously, except that support tube 802 can comprise a grip or textured portion 804 configured to promote frictional engagement between the support tube 802 and capsule. In some implementations, the support tube 802 can include a first side portion 802a and a second side portion 802b. In some implementations, the support tube only includes one portion. In some implementations, the grip portion 804 can be overmolded or adhesively secured onto an interior surface (once the support tube is assembled) of the support tube 802. In some implementations, the grip portion 804 can comprise a plurality of textured ridges. In some implementations, the grip portion 804 can comprise a material configured to promote frictional engagement. In some implementations, the grip portion 804 can comprise natural rubber or any of various synthetic elastomers, such as silicone, polyurethane, neoprene, etc.

[0126] In some implementations, the extension member 806 can comprise a main body 810 and a clamp portion 812. The clamp portion 812 can be the same as or similar to the first clamp 306a described previously. Namely, the clamp portion 812 can be placed over an end portion of the support tube 802 to hold the first and second side portions 802a, 802b together. Though not shown in FIGS. 18-20, in some implementations, the clamp portion 812 can comprise one or more tabs extending radially outwardly from an outer surface of the clampAttorney Docket No: TMTTMT-24152WO01portion 812 to aid the user in advancing the clamp extension member 806 over the support tube 802.

[0127] In some implementations, the main body 810 of the clamp extension member 806 can extend from the clamp portion 812 and can have a substantially cylindrical shape. The main body 810 can comprise a channel or opening 814 extending axially along the length of the main body 810 to facilitate placement of the clamp extension member 806 on the support tube 802. The opening 814 can allow the main body 810 to retain some flexibility.

[0128] In the implementation shown in FIGS. 18-20, the clamp extension member 806 takes the place of the first clamp 306a, however, in some implementations, the main body 810 of the clamp extension member 806 can be a separate component not coupled to the clamp portion 812 and sandwiched between the support tube 802 and the first and / or second clamp 306a, 306b.

[0129] As shown in FIG. 19, the holder member 808 can be disposed over a first or inlet end portion 816 of the support tube 802 to retain the first and second side portions 802a, 802b together. In some implementations, as shown, the holder member 808 can be an annular member defining an inner lumen 818 sized to be disposed over the inlet end portion 816 of the support tube 802. In some implementations, the holder member 808 can comprise a ridged outer surface 820 e.g., comprising a plurality of peaks and recesses. The ridged outer surface 820 can aid a user in grasping the holder member 808 and inserting the holder member 808 onto the support tube 802.

[0130] Referring now to FIG. 20, when the loading assembly comprising clamp extension member 806 is assembled on the capsule of the delivery apparatus the clamp extension member 806 extends along substantially the entire length of the support tube 802. The clamp extension member 806 provides circumferential compression around the support tube 802 and thereby around the capsule to provide a rigid tube structure. Such a configuration supports the flexible capsule during the loading process, thereby eliminating the need for tabs on the capsule, including a first side portion 802a and a second side portion 802b, the frictional engagement of the grip portion 804 with the capsule can further maximize the contact between the support tube 802 and the capsule, advantageously distributing the loading force (e.g., the force applied to the capsule when loading a prosthetic valve) along the length of the assembly (and therefore along the length of the capsule), avoiding damage to the capsule material.Attorney Docket No: TMTTMT-24152WO01

[0131] Referring now to FIGS. 21A-21D, in some implementations, a delivery apparatus, such as delivery apparatus 400 described previously, can further include a liner member 450. The liner member 450 can comprise a material having lubricious characteristics, for example, expanded polytetrafluoroehtylene EPTFE. In some implementations, the liner member 450 can be configured to encapsulate or surround the medical device 100 during loading to reduce friction between the medical device 100 and the capsule 402. Though the medical device 100 is illustrated and described as a frame 102 only, it should be understood that these concepts apply equally to the medical device 100 as a whole.

[0132] In some implementations, such as shown in FIGS. 21 A-21D, the liner member 450 can be coupled to the valve retaining member 410 of the delivery apparatus 400. In some implementations, the liner member 450 can be detachable, and in some implementations, the liner member can be permanently coupled e.g., to the valve retaining member 410. The liner member 450 can have a cylindrical shape similar to the shape of the capsule 402. Referring to FIG. 21 A, prior to coupling the frame 102 to the valve retaining member 410, the liner member 450 can be disposed in an everted configuration such that a first surface 452 of the liner member 450 contacts a radially outwardly facing surface 454 of the capsule 402.

[0133] In some implementations, the frame 102 can then be partially crimped or cinched and coupled to the valve retaining member 410 (e.g., using a crimping device 200 as described previously with reference to FIGS. 2 and 6-9), as shown in FIGS. 21B-21C. As the frame 102 is advanced into the capsule 402, as shown in FIG. 21 C, the liner member 450 everts and is advanced into the inner bore of the capsule 402 such that the first surface 452 now contacts a radially inwardly facing surface 456 of the capsule 402. In some implementations, the liner member 450 can advantageously serve as a funnel member to assist in loading the frame 102 into the capsule 402. In some implementations, a separate funnel, such as funnel member 304, can be used to facilitate loading of the prosthetic valve into the capsule 402.

[0134] As shown in FIG. 21 D, the liner member 450 remains within the capsule 402 surrounding the loaded frame 102. In some implementations, the liner member 450 can serve as a deliverable / retrievable funnel to facilitate repositioning and / or retrieval of the medical device when a funnel is needed. For example, as the medical device is deployed, the liner member 450 can likewise be deployed from the capsule. If it is necessary to recapture the medical device (e.g., for retrieval or repositioning) the liner member 450 can serve as a funnel member to assist in re -loading the medical device in the same or similar manner to the initial loading method.Attorney Docket No: TMTTMT-24152WO01

[0135] FIGS. 22-34 illustrate various examples of tab rings / holder members 900-1100 that can be used with loading assembly 300. In using loading assembly 300, the amount of radial compression required to hold the tabs 416 in the required position to maintain the capsule 402 taut during loading of a prosthetic device can be quite high. This can result in difficulty for the user when attempting to advance the tab ring / holder member over the support tube 302 to hold the tabs 416 in place. Accordingly, the holder members 900-1100 described herein advantageously provide the required radial compression to hold the tabs 416 taut under the relatively high loading forces. Further, the holder members 900-1100 described herein advantageously include a variable internal diameter that allows the holder members 900-1100 to work within a relatively large range of tolerances of capsule tab compression, as some delivery capsules require different compressive variation.

[0136] FIGS. 22-27 illustrate an example of a holder member 900 that can be used with loading assembly 300. Holder member 900 can be used in lieu of or in addition to holder member 308 and can generally comprise two main components: a first or outer member 902 and a second or inner member 904. The outer member 902 can define a first central lumen 906 extending longitudinally through the holder member 900. The inner member 904 can be disposed within the lumen 906 of the outer member 902 and can define a second central lumen 908.

[0137] As shown, the outer member 902 can have an annular shape including an outer surface 910 and an inner surface 912 that defines the lumen 906. In some implementations, the outer surface 910 can comprise a gripping portion configured to facilitate a user’s grip on the outer member 902 and facilitate disposing the outer member 902 over the inner member 904. For example, FIGS. 22-27 illustrate a gripping portion comprising a plurality of ridges 914 and valleys 916 disposed circumferentially around the outer surface 910. In other examples, the gripping portion can be implemented in any of various ways, including a textured or knurled surface, a circumferentially extending ridge, etc.

[0138] Referring to FIG. 23, the first central lumen 908 can taper from a first diameter DI at a first end portion 918 to a second, narrower diameter D2 at a second end portion 920. Such a configuration aids a user in advancing the outer member 902 over the inner member 904.

[0139] The inner member 904 can be an annular member comprising an outer surface 922 and an inner surface 924 defining the second central lumen 908, which extending along the length of the inner member. As shown in FIG. 23, the outer surface 922 of the inner memberAttorney Docket No: TMTTMT-24152WO01904 can taper from a third diameter D3 at a first end portion 926 to a fourth, narrower diameter D4 at a second end portion 928. When the inner member 904 is disposed within the outer member 902, the third diameter D3 can substantially correspond to the first diameter DI of the outer member, and the fourth diameter D4 can substantially correspond to the second diameter D2 of the outer member 902.

[0140] The size of the second lumen 908 can be adjustable such that the inner member 904 can easily be advanced over the capsule tabs 416 (FIG. 3) with the second lumen in an uncompressed configuration. The outer member 902 can be advanced over the inner member 904 to compress the inner member 904, thereby moving the inner member 904 to a compressed configuration, reducing the size of the second lumen 908, and retaining the tabs 416 in position. Referring to FIG. 24, the inner member 904 can comprise an opening / slot / slit 930 extending through the wall of the inner member 904 and along the length of the inner member 904. The slit 930 allows for the movement of the inner member 904 from the uncompressed configuration wherein the slit 930 has a first width W1 (see e.g., FIG. 27), to a compressed configuration (see e.g., FIG. 22) wherein the slit 930 has a second width W2, less than the first width Wl. In some implementations, when in the compressed configuration, the second width W2 can be essentially zero as the first and second surfaces 932, 934 (FIG. 24) defining the slit 930 between them may contact one another.

[0141] In use, the holder member 900 can be assembled over the tabs 416 to retain the tabs 416 against movement relative to the support tube 302. For example, the tabs 416 of the capsule 402 can be folded back over the inlet end portion 312 of the support tube 302 as described previously. The inner member 904 can be disposed over the folded tabs 416 around the inlet end portion 312 of the support tube 302. The outer member 902 can then be disposed over the inner member 904, for example, by placing the first end portion 918 of the outer member 902 adjacent the second end portion 928 of the inner member 904 and axially advancing the outer member 902 axially over the inner member 904. As the outer member 902 axially advances over the inner member 904, the tapering of the first lumen 906 moved the inner member 904 from the uncompressed configuration to the compressed configuration, thereby retaining the folded tabs 416 against movement relative to the support tube 302. This holds the capsule 402 in tension to keep the capsule taut, thereby preventing or mitigating bending / deformation of the capsule during the insertion / loading of the prosthetic valve 100. In some implementations, the holder member 900 further functions to help retain the side portions 302a, 302b of the support tube 302 in the assembled position.Attorney Docket No: TMTTMT-24152WO01

[0142] FIGS. 28-31 illustrate another example of a holder member 1000 for use with loading assembly 300. Holder member 1000 can be used in lieu of or in addition to holder members 308 and 900 described previously. Holder member 1000 can generally comprise two main components: an outer member 902 and an inner member 1004. The outer member 902 can be the same as described previously, including tapered central lumen 906, outer surface 910, inner surface 912, first end portion 918, and second end portion 920.

[0143] Referring to FIG. 29, the inner member 1004 can be an annular member comprising an outer surface 1006 and an inner surface 1008 defining a second central lumen 1010. Referring to FIG. 28, the inner member 1004 can comprise two or more side portions 1012, for example, a first side portion 1012a and a second side portion 1012b, defined by one or more slits / openings / slots 1014 (e.g., two slits 1014a and 1014b) extending radially through the wall of the inner member 1004 and along the length of the inner member 1004. While the illustrated example shows first and second side portions 1012a, 1012b separated by first and second slits 1014a, 1014b, other examples may comprise three or more side portions 1012 separated by three or more slits 1014.

[0144] As shown in FIG. 29, the outer surface 1006 of the inner member 1004 can taper similar to inner member 904 described previously. For example, the outer surface 1006 of inner member 1004 can taper from a third diameter D3 at a first end portion 1016 to a fourth, smaller diameter D4 at a second end portion 1018. When the inner member 1004 is disposed within the outer member 902, the third diameter D3 can substantially correspond to the first diameter DI of the outer member 902, and the fourth diameter D4 can substantially correspond to the second diameter D2 of the outer member 902.

[0145] As shown in FIG. 29, the inner member 1004 comprises one or more circumferentially extending recesses 1020 in the outer surface 1006 that extend inwardly toward the central lumen 1010. The inner member 1005 further comprises one or more retaining rings 1022 (e.g., elastomeric rings such as O-rings, etc.) disposed within the one or more recesses 1020. In the examples shown in FIGS. 28-31, the inner member 1004 comprises first and second recesses 1020a, 1020b and first and second retaining rings 1022a, 1022b. In other examples, the inner member 1004 can comprise a greater or fewer number of recesses 1020 and retaining rings 1022. The side portions 1012 and retaining rings 1022 are configured to allow a user to expand the first and second side portions 1012a, 1012b laterally away from one another (thereby adjusting the diameter of the central lumen 1010) while stillAttorney Docket No: TMTTMT-24152WO01retaining the side portions 1012 together, for example, to dispose the inner member 1004 over the tabs 416 at the inlet end portion 312 of the support tube 302.

[0146] The one or more slits 1014 allow for the movement of the inner member 1004 between an uncompressed / relaxed configuration (see e.g., FIG. 30) wherein the one or more slits 1014 each have a first width W1 and a compressed configuration (see e.g., FIG. 28) wherein the slits 1014 have a second width W2, less than the first width Wl. The inner member 1004 can also be movable to an expanded configuration via application of force (e.g., by a user) to move the side portions 1012 laterally away from one another. In such a configuration, the width of the slits 1014 is a third width greater than the first and second widths Wl, W2. In some implementations, when in the compressed configuration, the second width W2 can be essentially zero as the first and second side portions 1012 may contact one another along their longitudinal edges.

[0147] In use, the holder member 1000 can be assembled over the tabs 416 to retain the tabs 416 against movement relative to the support tube 302 in the following exemplary manner. For example, the tabs 416 of the capsule 402 can be folded back over the inlet end portion 312 of the support tube 302 as described previously. The inner member 1004 can be disposed over the folded tabs 416 around the inlet end portion 312 of the support tube 302 by moving the inner member into the expanded configuration and advancing the member 1004 over the tabs 416. For example, a user can pull the side portions 1012a, 1012b laterally away from one another and advancing the member 1004 over the inlet end portion 312 and tabs 416. The outer member 902 can then be disposed over the inner member 1004, for example, by placing the first end portion 918 of the outer member 902 adjacent the second end portion 1018 of the inner member 1004 and axially advancing the outer member 902 axially over the inner member 1004. As the outer member 902 axially advances over the inner member 1004, the tapered central lumen 906 moves inner member 1004 from the uncompressed configuration to the compressed configuration, thereby retaining the folded tabs 416 against movement relative to the support tube 302. This holds the capsule 402 in tension to keep the capsule taut, thereby preventing or mitigating bending / deformation of the capsule during the insertion / loading of the prosthetic valve 100. In some implementations, the holder member 1000 further functions to help retain the side portions 302a, 302b of the support tube 302 in the assembled position.

[0148] FIGS. 32-34 illustrate an example of a holder member 1100 that can be used with loading assembly 300. Holder member 1100 can be used in lieu of or in addition to holderAttorney Docket No: TMTTMT-24152WO01members 308, 900, or 1000 described previously. Holder member 1100 generally comprises two main components: a main body 1102 and a locking member 1104. While holder member 1100 can be used as a standalone holder member as described below, in some implementations, the holder member 1100 can be used in combination with one or more of the inner members described previously, such as inner members 904 and 1004.

[0149] The main body 1102 is a C-shaped member comprising an outer surface 1106 and an inner surface 1108 that defines a central lumen 1110 extending longitudinally through the holder member 1100. The outer surface 1106 can comprise a gripping portion 1112 configured to facilitate a user’s grip on the outer member 1100. For example, FIGS. 32-34 illustrate a gripping portion 1112 comprising a plurality of ridges 1114 and valleys 1116 disposed circumferentially around the outer surface 1106. In other examples, the gripping portion 1112 can be implemented in any of various ways, including a textured or knurled surface, a circumferentially extending ridge, etc.

[0150] The outer surface 1106 can further comprise a plurality of flexion cuts 1118 disposed within the valleys 1116 and extending radially inwardly toward the central lumen 1110. The flexion cuts 1118 extend axially along the length of the main body 1102 and are configured to allow the annular main body 1102 to flex between a relaxed configuration (see e.g., FIG. 34) wherein the locking member 1104 is in an unlocked configuration, a compressed configuration (see e.g., FIG. 32) wherein the locking member 1104 is in a locked configuration, and an expanded configuration wherein force is applied by a user to hold the main body 1102 in an expanded configuration. For example, a user can move a first end 1120 and a second end 1122 of the main body 1120 laterally away from one another to move the main body into the expanded configuration. The central lumen 1110 can have a first diameter DI when in the relaxed configuration (FIG. 34), a second diameter D2 when in the compressed configuration (FIG. 33), and a third diameter when in the expanded configuration. The first diameter DI can be larger than the second diameter D2, and the third diameter can be larger than both DI and D2. The expanded configuration allows the user to more easily dispose the holder member 1100 over the inlet end portion 312 of the support tube 302. The main body 1102 can be configured to bias back into the relaxed configuration when the force is removed. The user can then move the locking member 1104 into the locked position, reducing the size of the central lumen 1110 to retain the holder member 1100 on the support tube 302.Attorney Docket No: TMTTMT-24152WO01

[0151] A first end portion 1124 of the locking member 1104 can be pivotably coupled to the first end portion 1120 of the main body 1102, for example, via a pivot pin 1126 (FIG. 34) extending through openings 1128 (FIG. 33) in the first end portion 1120 and locking member 1104. The locking member 1104 can rotate around pivot pin 1126 between a locked configuration (FIG. 33) wherein a second end portion 1130 of the locking member 1104 engages a locking feature 1132 (FIG. 34) and an unlocked configuration (see FIG. 34) wherein the second end portion 1130 of the locking member 1104 does not engage the locking feature 1 132.

[0152] The second end portion 1130 of the locking member 1104 can comprise an engagement feature 1134 configured to engage the corresponding locking feature 1132 of the second end portion 1122 of the main body 1120. In the illustrated example, the engagement feature 1134 is a hooked or J-shaped portion and the corresponding locking feature is a locking post 1136. The hooked portion 1134 snaps over the locking post 1136 to hold the second end portion 1130 of the locking member 1 104 in place, thereby moving the holder member 1100 into the locked configuration. In other examples, the engagement feature and locking feature can be any of various releasably interlocking features. For example, in some instances the engagement feature can be a hooked member and the locking feature can be an extrusion, protrusion, bump, pin, or post.

[0153] In some implementations, such as shown in FIGS. 32-34, the second end portion 1130 of the locking member 1104 can comprise a projection or protrusion 1138 configured (i.e., sized, shaped, and oriented) to allow a user to grab the projection 1138 to actuate the locking member 1104 between the locked and unlocked positions.

[0154] Referring to FIG. 34, the first end portion 1120 of the main body 1102 can comprise a first recess 1140 and the second end portion 1122 of the main body 1102 can comprise a second recess 1142 in which the corresponding locking feature (e.g., locking post 1136) is disposed. The first end portion 1 124 of the locking member 1 104 can be pivotably coupled to the main body 1102 within the first recess 1140 (e.g., via the pivot pin 1126) such that when the holder member 1100 is in the locked position (FIG. 33) the outer surface 1144 of the locking member 1104 can be substantially flush with the outer surface 1106 of the main body 1102.

[0155] In use, the holder member 1100 can be assembled over the tabs 416 to retain the tabs 416 against movement relative to the support tube 302 in the following exemplary manner.Attorney Docket No: TMTTMT-24152WO01The tabs 416 of the capsule 402 can be folded back over the inlet end portion 312 of the support tube 302 as described previously. The holder member 1100 in the unlocked configuration can be disposed over the folded tabs 416 around the inlet end portion 312, e.g., by flexing the first and second end portions 1120, 1122 of the main body 1102 away from one another and advancing the central lumen 1110 over the inlet end portion 312 and tabs 416. A user can then actuate the locking member 1104 from the unlocked position to the locked position by pivoting the locking member 1104 until the engagement feature 1134 engages the corresponding locking feature 1132. This reduces the diameter of the central lumen 1110, thereby tightening the holder member 1100 around the inlet end portion 312 and retaining the folded tabs 416 against movement relative to the support tube 302. This holds the capsule 402 in tension to keep the capsule taut, thereby preventing or mitigating bending / deformation of the capsule during the insertion / loading of the prosthetic valve 100. In some implementations, the holder member 1100 further functions to help retain the side portions 302a, 302b of the support tube 302 in the assembled position.

[0156] Any of the systems, devices, apparatuses, etc. herein can be sterilized (for example, with heat / thermal, pressure, steam, radiation, and / or chemicals, etc.) to ensure they are safe for use with patients, and any of the methods herein can include sterilization of the associated system, device, apparatus, etc. as one of the steps of the method. Examples of heat / thermal sterilization include steam sterilization and autoclaving. Examples of radiation for use in sterilization include, without limitation, gamma radiation, ultra-violet radiation, and electron beam. Examples of chemicals for use in sterilization include, without limitation, ethylene oxide, hydrogen peroxide, peracetic acid, formaldehyde, and glutaraldehyde. Sterilization with hydrogen peroxide may be accomplished using hydrogen peroxide plasma, for example.

[0157] The techniques, methods, processes, operations, steps, etc. described or suggested herein or in the references incorporated herein, and any methods of using the systems, assemblies, apparatuses, devices, etc. herein, can be performed on a living subject (e.g., human, other animal, etc.) or on a simulation (e.g., a cadaver, cadaver heart, simulator, imaginary person, etc.). When performed on a simulation, the body parts, e.g., heart, tissue, valve, etc., can be assumed to be simulated or can optionally be referred to as “simulated” (e.g., simulated heart, simulated tissue, simulated valve, etc.) and can optionally comprise computerized and / or physical representations of body parts, tissue, etc. The term “simulation” covers use on a cadaver, computer simulator, imaginary person (e.g., if they are just demonstrating in the air on an imaginary heart), etc.Attorney Docket No: TMTTMT-24152WO01Additional Examples

[0158] In view of the above-described implementations of the disclosed subject matter, this application discloses the additional examples enumerated below. It should be noted that one feature of an example in isolation or more than one feature of the example taken in combination and, optionally, in combination with one or more features of one or more further examples are further examples also falling within the disclosure of this application.

[0159] Example 1. A delivery apparatus, comprising: a capsule including a plurality of perforations that extend around a circumference of the capsule and define a distal end portion of the capsule and a main portion of the capsule.

[0160] Example 2. The delivery apparatus of any example herein, particularly example 1, wherein the distal end portion of the capsule comprises one or more tabs.

[0161] Example 3. The delivery apparatus of any example herein, particularly any one of examples 1-2, wherein the plurality of perforations comprise openings that extend radially through a wall of the capsule.

[0162] Example 4. A method of loading a medical device into a delivery apparatus, the method comprising: disposing a support tube of a loading assembly over a capsule of the delivery apparatus, the capsule comprising a plurality of perforations that extend around a circumference of the capsule, the perforations defining a distal end portion of the capsule and a main portion of the capsule; advancing a prosthetic valve axially through a funnel segment of a crimping device and at least partially through an outlet of the crimping device; advancing the loading assembly axially over the prosthetic valve, thereby radially crimping the prosthetic valve and advancing the prosthetic valve into the capsule of the delivery apparatus; and removing the distal end portion of the capsule by tearing the distal end portion of the capsule along the plurality of perforations.

[0163] Example 5. An assembly, comprising: a delivery apparatus comprising a capsule including a removable strip of material that extends around a circumference of the capsule and defines a distal end portion of the capsule and a main portion of the capsule; wherein the distal end portion of the capsule is configured to be removed from the main portion of the capsule by removing the removable strip of material.

[0164] Example 6. The assembly of any example herein, particularly example 5, wherein the distal end portion of the capsule comprises one or more tabs.

[0165] Example 7. The assembly of any example herein, particularly any one of examples 5-6, wherein the removable strip is formed from the same material as the capsule.Attorney Docket No: TMTTMT-24152WO01

[0166] Example 8. The assembly of any example herein, particularly any one of examples 5-7, wherein the removable strip comprises a reinforcing member.

[0167] Example 9. The assembly of any example herein, particularly any one of examples 5-8, wherein the removable strip comprises a first row of circumferentially-extending perforations adjacent a first edge and a second row of circumferentially-extending perforations adjacent a second edge.

[0168] Example 10. The assembly of any example herein, particularly any one of examples 5-9, wherein a gripping portion of the removable strip protrudes from a radially outwardly facing surface of the capsule.

[0169] Example 11. A method of loading a medical device into a delivery apparatus, the method comprising: disposing a support tube of a loading assembly over a capsule of the delivery apparatus, the capsule comprising a removable strip of material that extends around a circumference of the capsule and defines a distal end portion of the capsule and a main portion of the capsule; advancing a prosthetic valve axially through a funnel segment of a crimping device and at least partially through an outlet of the crimping device; advancing the loading assembly axially over the prosthetic valve, thereby radially crimping the prosthetic valve and advancing the prosthetic valve into the capsule of the delivery apparatus; and removing the distal end portion of the capsule by removing the removable strip.

[0170] Example 12. The method of any example herein, particularly example 11, wherein removing the removable strip comprises gripping a gripping portion of the removable strip that protrudes from a surface of the capsule and tearing the removable strip out of the capsule.

[0171] Example 13. A method of loading a medical device into a delivery apparatus, the method comprising: everting a distal end portion of a capsule of a shaft of a delivery apparatus such that the capsule comprises a first layer and a second layer disposed at least partially over the first layer; disposing a support tube of a loading assembly over the first and second layers of the capsule; advancing a medical device axially through a funnel segment of a crimping device and at least partially through an outlet of the crimping device; advancing the loading assembly axially over the medical device, thereby radially crimping the medical device and advancing the medical device partially into the capsule of the delivery apparatus; and removing the loading assembly from the capsule and unfolding the second layer such that the medical device is fully retained within the capsule.

[0172] Example 14. An assembly, comprising: a delivery apparatus comprising a capsule configured to receive a medical device; a loading assembly, comprising: a support tubeAttorney Docket No: TMTTMT-24152WO01disposed over the capsule of the delivery apparatus; a funnel member coupled to the support tube; a loading funnel disposed within the funnel member; and wherein a distal end portion of the capsule is clamped between the funnel member and the loading funnel to hold the capsule in tension.

[0173] Example 15. The assembly of any example herein, particularly example 14, wherein the loading funnel is retained within the funnel member via a friction fit.

[0174] Example 16. A loading assembly, comprising: a support tube configured to be disposed over a capsule of a delivery apparatus; a funnel member coupled to the support tube; and a loading funnel disposed within the funnel member; wherein the loading assembly is configured to retain a distal end portion of the capsule between the funnel member and the loading funnel to hold the capsule in tension.

[0175] Example 17. The loading assembly of any example herein, particularly any one of examples 16, wherein the loading funnel is retained within the funnel member via a friction fit.

[0176] Example 18. An assembly, comprising: a delivery apparatus comprising a capsule configured to receive a medical device, a distal end portion of the capsule comprising one or more first engagement features; a loading assembly, comprising: a support tube disposed over the capsule of the delivery apparatus, wherein the support tube comprises one or more second engagement features configured to engage the one or more first engagement features to hold the capsule in tension.

[0177] Example 19. The assembly of any example herein, particularly example 18, wherein the loading assembly further comprises a funnel member coupled to the support tube, and one or more clamps configured to retain the first and second side portions of the support tube together.

[0178] Example 20. The assembly of any example herein, particularly any one of examples 18-19, wherein the first engagement features comprise protrusions and the second engagement features comprise openings.

[0179] Example 21. The assembly of any example herein, particularly example 20, wherein the protrusions have a circular shape in cross-section.

[0180] Example 22. An assembly, comprising: a delivery apparatus comprising a capsule configured to receive a medical device; a loading assembly, comprising: a support tube disposed over the capsule of the delivery apparatus, the support tube comprising first and second portions; a funnel member coupled to the support tube; and a clamp extension member configured to retain the first and second side portions of the support tube together,Attorney Docket No: TMTTMT-24152WO01the clamp extension member comprising a main body and a clamp member, the main body extending substantially the length of the support tube when disposed thereon; wherein the main body of the clamp extension member provides circumferential compression along a length of the support tube.

[0181] Example 23. The assembly of any example herein, particularly example 22, wherein the support tube comprises a gripping portion disposed on an internal surface of the support tube and configured to create frictional engagement between the support tube and the capsule.

[0182] Example 24. The assembly of any example herein, particularly any one of examples 22-23, wherein the main body of the clamp extension member has a substantially cylindrical shape.

[0183] Example 25. The assembly of any example herein, particularly any one of examples 22-24, wherein the main body of the clamp extension member comprises a channel extending axially along a length of the main body.

[0184] Example 26. A loading assembly, comprising; a support tube configured to be disposed on a capsule of a delivery apparatus, the support tube comprising first and second portions; a funnel member coupled to the support tube; and a clamp extension member configured to retain the first and second side portions of the support tube together, the clamp extension member comprising a main body and a clamp member, the main body extending substantially a length of the support tube when disposed thereon; wherein the main body of the clamp extension member provides circumferential compression along a length of the support tube.

[0185] Example 27. The loading assembly of any example herein, particularly example 26, wherein the support tube comprises a gripping portion disposed on an inner surface of the support tube and configured to create frictional engagement between the support tube and the capsule.

[0186] Example 28. The loading assembly of any example herein, particularly any one of examples 26-27, wherein the main body of the clamp extension member has a substantially cylindrical shape.

[0187] Example 29. The loading assembly of any example herein, particularly any one of examples 26-28, wherein the main body of the clamp extension member comprises a channel extending axially along a length of the main body.

[0188] Example 30. A loading assembly comprising: a support tube configured to be disposed on a capsule of the delivery apparatus; and one or more gripping portions disposedAttorney Docket No: TMTTMT-24152WO01on an inner surface of the support tube for gripping an outer surface of the capsule when disposed inside the support tube.

[0189] Example 31. A delivery apparatus, comprising: a first shaft; a second shaft disposed over the first shaft, a distal end portion of the second shaft comprising a capsule configured to receive a medical device; a retaining member disposed on the first shaft and configured to releasably couple an end portion of a medical device; and a liner member coupled to the retaining member; wherein prior to loading a medical device into the capsule, the liner member is everted over an outer surface of the capsule and as the medical device is advanced into the capsule the liner member is also advanced into the capsule thereby reducing friction between the medical device and the capsule.

[0190] Example 32. The delivery apparatus of any example herein, particularly example 31, wherein the liner member is detachably coupled to the retaining member.

[0191] Example 33. The delivery apparatus of any example herein, particularly any one of examples 31-32, wherein the liner member has a cylindrical shape.

[0192] Example 34. The delivery apparatus of any example herein, particularly any one of examples 31-33, wherein the liner is more lubricious than an inner surface of the capsule.

[0193] Example 35. A method of loading a medical device into a delivery apparatus, the method comprising: disposing a liner member in an everted configuration over a capsule of a delivery apparatus, the liner member coupled to a retaining member, the liner member comprising a material having lubricious characteristics; coupling a medical device to the retaining member in a partially crimped configuration; advancing the retaining member and medical device into the capsule such that the liner member is also advanced into the capsule thereby reducing friction between the medical device and the capsule.

[0194] Example 36. A loading assembly, comprising: a support tube configured to be disposed on a capsule of a delivery apparatus; a funnel member coupled to the support tube; and a holder member configured to be disposed over a first end of the support tube to restrain the capsule against movement relative to the support tube.

[0195] Example 37. The loading assembly of any example herein, particularly example 36, wherein the holder member comprises: an annular outer member defining a first central lumen tapering from a first diameter at a first end portion to a second, smaller diameter at a second end portion; an annular inner member and comprising a slit extending through a wall of the inner member and along a length of the inner member, inner member defining a second central lumen extending along the length of the inner member; wherein advancing the outer member over the inner member moves the inner member from a relaxed configurationAttorney Docket No: TMTTMT-24152WO01wherein the second central lumen has a first diameter to a compressed configuration wherein the second central lumen has a second, smaller diameter.

[0196] Example 38. The loading assembly of any example herein, particularly example 36, wherein the holder member comprises: a main body defining a central lumen, the main body comprising a C-shape including a first end portion and a second end portion; a locking member comprising a first end and a second end, the first end pivotably coupled to the first end portion of the main body and the second end comprising an engagement feature; wherein the locking member is pivotable between an unlocked configuration, wherein the engagement feature is not engaged, and a locked configuration wherein the engagement feature engages a corresponding locking feature of the second end portion of the main body; and wherein when the locking member is in the unlocked configuration the central lumen has a first diameter and wherein when the locking member is in the locked configuration the central lumen has a second diameter smaller than the first diameter.

[0197] Example 39. A holder member for restraining a capsule of a delivery apparatus against movement relative to a support tube, comprising: an annular outer member defining a first central lumen tapering from a first diameter at a first end portion to a second, smaller diameter at a second end portion; an annular inner member and comprising a slit extending through a wall of the inner member and along a length of the inner member, inner member defining a second central lumen extending along the length of the inner member; wherein advancing the outer member over the inner member moves the inner member from a relaxed configuration wherein the second central lumen has a first diameter to a compressed configuration wherein the second central lumen has a second, smaller diameter.

[0198] Example 40. The holder member of any example herein, particularly example 49, wherein the inner member comprises a flexible polymer.

[0199] Example 41. The holder member of any example herein, particularly any one of examples 39-40, wherein the outer member comprises a ridged outer surface.

[0200] Example 42. The holder member of any example herein, particularly any one of examples 39-41, wherein the inner member comprises first and second side portions and further comprises one or more retaining rings configured to retain the first and second side portions together.

[0201] Example 43. The holder member of any example herein, particularly example 42, wherein the one or more retaining rings are disposed within respective circumferentially extending recesses in an outer surface of the inner member.Attorney Docket No: TMTTMT-24152WO01

[0202] Example 44. The holder member of any example herein, particularly any one of examples 39-43, wherein the holder member is further movable to an expanded configuration wherein the second central lumen has a third diameter larger than the first or second diameters.

[0203] Example 45. A holder member for restraining a capsule of a delivery apparatus against movement relative to a support tube, comprising: a main body defining a central lumen, the main body comprising a C-shape including a first end portion and a second end portion; a locking member comprising a first end and a second end, the first end pivotably coupled to the first end portion of the main body and the second end comprising an engagement feature; wherein the locking member is pivotable between an unlocked configuration, wherein the engagement feature is not engaged, and a locked configuration wherein the engagement feature engages a corresponding locking feature of the second end portion of the main body; and wherein when the locking member is in the unlocked configuration the central lumen has a first diameter and wherein when the locking member is in the locked configuration the central lumen has a second diameter smaller than the first diameter.

[0204] Example 46. The holder member of any example herein, particularly example 45, wherein an outer surface of the main body comprises a plurality of flexion cuts extending from the outer surface toward the central lumen.

[0205] Example 47. The holder member of any example herein, particularly any one of examples 45-46, wherein the holder member is movable into an expanded configuration wherein the first end portion and second end portion are moved laterally away from one another, and wherein the central lumen has a third diameter larger than the first and second diameters.

[0206] In view of the many possible examples to which the principles of the disclosure may be applied, it should be recognized that the illustrated examples are only examples and should not be taken as limiting the scope of the disclosure. Rather, the scope is at least as broad as the following claims and equivalents of the recited features. We therefore claim all that comes within the scope and spirit of these claims.

Claims

Attorney Docket No: TMTTMT-24152WO01We claim:

1. An assembly, comprising:a delivery apparatus including a capsule including a removable distal end portion of the capsule and a main portion of the capsule.

2. The assembly of claim 1, wherein the distal end portion of the capsule comprises one or more tabs.

3. The assembly of any one of claims 1-2, wherein the distal end portion of the capsule is defined by a plurality of perforations that extend around a circumference of the capsule.

4. The assembly of claim 3, wherein the plurality of perforations comprise openings that extend radially through a wall of the capsule.

5. The assembly of any one of claims 1-2, wherein the distal end portion of the capsule is coupled to the main portion of the capsule via a removable strip of material that extends around a circumference of the capsule and wherein the distal end portion is configured to be removed from the main portion of the capsule by removing the removable strip of material.

6. The assembly of claim 5, wherein the removable strip is formed from the same material as the capsule.

7. The assembly of any one of claims 5-6, wherein the removable strip comprises a reinforcing member.

8. The assembly of any one of claims 5-7, wherein the removable strip comprises a first row of circumferentially-extending perforations adjacent a first edge and a second row of circumferentially-extending perforations adjacent a second edge.

9. The assembly of any one of claims 5-8, wherein a gripping portion of the removable strip protrudes from a radially outwardly facing surface of the capsule.Attorney Docket No: TMTTMT-24152WO0110. A method of loading a medical device into a delivery apparatus, the method comprising:disposing a support tube of a loading assembly over a capsule of the delivery apparatus, the capsule comprising a removable distal end portion removably coupled to a main portion;advancing the support tube axially over the prosthetic valve, thereby radially crimping the prosthetic valve and advancing the prosthetic valve into the capsule of the delivery apparatus; andremoving the removable distal end portion of the capsule from the main portion of the capsule.

11. The method of claim 10, wherein the capsule comprises a plurality of perforations that extend around a circumference of the capsule defining the distal end portion of the capsule and the main portion of the capsule.

12. The method of claim 11, wherein removing the distal end portion of the capsule from the main portion comprises tearing the distal end portion along the plurality of perforations.

13. The method of claim 10, wherein the capsule comprises a removable strip of material that extends around a circumference of the capsule and defines the distal end portion of the capsule and the main portion of the capsule.

14. The method of claim 13, wherein removing the distal end portion of the capsule includes removing the removable strip to separate the distal end portion from the main portion.

15. The method of claim 14, wherein removing the removable strip comprises gripping a gripping portion of the removable strip that protrudes from a surface of the capsule and tearing the removable strip out of the capsule.

16. An assembly, comprising:a delivery apparatus comprising a capsule configured to receive a medical device; a loading assembly, comprising:Attorney Docket No: TMTTMT-24152WO01a support tube disposed over the capsule of the delivery apparatus, the support tube comprising first and second portions;a funnel member coupled to the support tube; anda clamp extension member configured to retain the first and second side portions of the support tube together, the clamp extension member comprising a main body and a clamp member, the main body extending substantially the length of the support tube when disposed thereon;wherein the main body of the clamp extension member provides circumferential compression along a length of the support tube.

17. The assembly of claim 16, wherein the support tube comprises a gripping portion disposed on an internal surface of the support tube and configured to create frictional engagement between the support tube and the capsule.

18. The assembly of any one of claims 16-17, wherein the main body of the clamp extension member has a substantially cylindrical shape.

19. The assembly of any one of claims 16-18, wherein the main body of the clamp extension member comprises a channel extending axially along a length of the main body.

20. An assembly, comprising:a delivery apparatus, comprising:a first shaft;a second shaft disposed over the first shaft, a distal end portion of the second shaft comprising a capsule configured to receive a medical device;a retaining member disposed on the first shaft and configured to releasably couple an end portion of a medical device; anda liner member coupled to the retaining member:wherein prior to loading a medical device into the capsule, the liner member is everted over an outer surface of the capsule and as the medical device is advanced into the capsule the liner member is also advanced into the capsule thereby reducing friction between the medical device and the capsule.Attorney Docket No: TMTTMT-24152WO0121. The assembly of claim 31, wherein the liner member is detachably coupled to the retaining member.

22. The assembly of any one of claims 31-32, wherein the liner member has a cylindrical shape.

23. The assembly of any one of claims 31-33, wherein the liner is more lubricious than an inner surface of the capsule.

24. An assembly, comprising:a loading assembly including:a support tube configured to be disposed on a capsule of a delivery apparatus; a funnel member coupled to the support tube; anda holder member configured to be disposed over a first end of the support tube to restrain the capsule against movement relative to the support tube,wherein the holder member is movable between a relaxed configuration wherein a central lumen has a first diameter and a compressed configuration wherein the central lumen has a second, smaller diameter.

25. The assembly of claim 24, wherein the central lumen is a second central lumen and wherein the holder member further comprises:an annular outer member defining a first central lumen tapering from a first diameter at a first end portion to a second, smaller diameter at a second end portion;an annular inner member and comprising a slit extending through a wall of the inner member and along a length of the inner member, inner member defining the second central lumen extending along the length of the inner member; wherein advancing the outer member over the inner member moves the inner member from the relaxed configuration to the compressed configuration.

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