Systems and methods for compressing and loading prosthetic heart valves - Patents.com

Abstract

The assembly may include a delivery apparatus, a compression device, and a loading assembly. The compression device may include a housing disposed over a first shaft of the delivery apparatus and configured to receive the radially expandable and compressible prosthetic valve in a radially expanded state. The housing may have a funnel segment extending at least partially along the housing and an outlet. The compression device may further include a pushing member and an actuator removably coupled to the pushing member, whereby driving the actuator forward relative to the housing drives the prosthetic valve through the funnel segment, whereby the prosthetic valve is radially compressed by engagement with the funnel segment and is expelled from the compression device via the outlet. The loading assembly may include a support tube disposed over a second shaft of the delivery apparatus and a funnel member disposed over a first end portion of the support tube.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Application No. 63 / 272,577, filed October 27, 2021, which is incorporated herein by reference.

[0002] The present disclosure relates to systems and methods for compressing an implantable prosthetic device, such as a prosthetic heart valve, for delivery into a patient's body. [Background technology]

[0003] The human heart can suffer from a variety of valvular diseases that can cause serious cardiac dysfunction and ultimately require replacement of the natural valve with an artificial valve. Numerous repair devices (e.g., stents) and artificial valves are known, as are numerous methods for implanting the devices and valves in humans. Percutaneous and minimally invasive surgical approaches are used in a variety of procedures to deliver artificial medical devices to locations within the body that are not easily accessible by surgery and where access without surgery is desirable. In one embodiment, the artificial heart valve can be loaded in a compressed state onto the distal end of a delivery device and advanced through the patient's vascular system (e.g., through the femoral artery and aorta) to reach the implantation site within the heart. The prosthetic heart valve is then expanded to its functional size, for example, by inflating a balloon in which it is mounted, or by activating a mechanical actuator that applies an expansive force to the prosthetic heart valve, or by deploying the prosthetic heart valve from a sheath of a delivery device, allowing the prosthetic heart valve to self-expand to its functional size.

[0004] Prosthetic valves for use in such procedures can include a radially collapsible and expandable frame to which the leaflets of the prosthetic valve can be attached. The leaflets are typically formed from biological materials, such as pericardial or harvested valves. To improve post-deployment function, it is often desirable for such valves to be packaged and stored in an open (i.e., expanded) diameter in a preservation solution until they are loaded onto a delivery device for implantation. Thus, the valve may need to be compressed minutes before implantation in the operating room, and thus pre-compression by the manufacturer is not possible. Thus, many loading and / or compression devices are now shipped as disposable accessories with the valve and delivery system, which increases the importance of their portability and ease of use.

[0005] In general, conventional loading and compression devices operate in one of two ways. In one approach, the stent is forced through a conical surface, compressing it to a smaller diameter. For example, a static conical tube can be passed over the stent to reduce its diameter. This approach is typically used when compressing prosthetic valves that have an easily deformable self-expanding metal frame (e.g., a Nitinol frame). The self-expanding prosthetic valve is typically forced through the conical tube of the loading / compression device and into the sheath of the delivery device, which holds the prosthetic valve in radial compression. In the second compression approach, compression jaws are used to create a cylindrical surface that can change diameter. This approach is typically used when compressing prosthetic valves that have a plastically expandable frame (e.g., a frame made of stainless steel or cobalt chrome alloy).

[0006] Self-expanding prosthetic valves typically have multiple connection features extending from a frame that form a detachable connection to the distal end of a delivery device. After the prosthetic valve is deployed from the sheath within the patient's body, the physician can release the connection between the delivery device and the prosthetic valve's connection features. Challenges in compressing self-expanding prosthetic valves include the physician's ability to easily and quickly compress and load the prosthetic valve into the sheath of the delivery device while aligning and connecting the prosthetic valve's connection features to the mating connection features of the delivery device. Thus, there remains a need for improved loading and compression devices that address these and other shortcomings in the prior art. Summary of the Invention

[0007] Described herein are various exemplary devices and methods for compressing prosthetic heart valves and for loading such valves into delivery apparatus.

[0008] The compression device can include a housing sized to receive a radially expandable and compressible prosthetic heart valve in a radially expanded state, the housing including a funnel segment extending at least partially along an axial length of the housing, an actuator, and a pushing member coupled to the actuator, the pushing member configured to abut against the prosthetic valve inside the housing and configured to drive the prosthetic valve axially through the funnel segment.

[0009] In addition to these components, the compression device may further include one or more of the components disclosed herein.

[0010] In some examples, the compression device can include an extender portion extending from the inlet portion of the housing and including a threaded inner surface, and a correspondingly threaded outer surface on a cylindrical extension member of the housing.

[0011] In some examples, the threaded inner surface of the housing and the threaded outer surface of the actuator are configured to translate rotational movement of the actuator into axial forward movement of the pushing member into the funnel segment of the housing.

[0012] In some examples, the housing includes a first side and a second side, the first side and the second side being removably coupled to one another using one or more engagement members.

[0013] In some examples, the one or more engagement members include a flange extending laterally from an outer surface of the first side and a hook-like member extending laterally from the outer surface of the second side and configured to receive the flange.

[0014] In a representative example, the compression device may include a housing sized to receive a radially expandable and compressible prosthetic heart valve in a radially expanded state. The housing may include a funnel segment extending at least partially along an axial length of the housing, an outlet in communication with the funnel segment, and an extender portion extending from the inlet portion of the housing, the extender portion including a threaded inner surface. The compression device may further include an actuator including a base and a cylindrical extension member having a corresponding threaded outer surface configured to engage the threaded inner surface of the extender portion, and a pusher member coupled to the base of the actuator and configured to abut against the prosthetic valve within the housing. The inner surface of the housing and the threaded outer surface of the actuator may be configured to translate rotational movement of the actuator into axial forward movement of the pusher member into the funnel segment of the housing, whereby the prosthetic valve is driven axially through the funnel segment.

[0015] In another representative example, the compression device can include a housing sized to receive a radially expandable and compressible prosthetic heart valve in a radially expanded state. The housing can include a funnel segment extending at least partially along an axial length of the housing, an outlet in communication with the funnel segment, and an extender portion extending from the inlet portion of the housing, the extender portion including a threaded inner surface. The compression device can further include an actuator including a base and a cylindrical extension member having a correspondingly threaded outer surface configured to engage the threaded inner surface of the extender portion, and a pusher member coupled to the actuator base and sized to abut against the prosthetic valve within the housing, the pusher member having an outer diameter smaller than an inner diameter of the housing such that the pusher member can be driven forward into the housing, and further including a plurality of arms extending from a first end portion, each arm including a seat configured to engage an adjacent end portion of the prosthetic valve. The inner surface of the housing and the threaded outer surface of the actuator are configured to translate rotational movement of the actuator into axial forward movement of the pushing member into the funnel segment of the housing, thereby driving the artificial valve axially through the funnel segment.

[0016] In yet another representative example, the compression device can include a housing sized to receive a radially expandable and compressible prosthetic heart valve in a radially expanded state. The housing can include a funnel segment extending at least partially along an axial length of the housing and an outlet in communication with the funnel segment, and further includes a first side and a second side, the first side and the second side being removably coupled together via a first pair of engaging members and a second pair of engaging members that hold the first side and the second side against lateral movement relative to one another. The compression device can further include an actuator including a base, and a pushing member coupled to the base of the actuator and configured to abut against the prosthetic valve within the housing. The first pair of engaging members can include first and second engaging members disposed radially opposite one another adjacent the inlet end of the housing, and the second pair of engaging members includes third and fourth members disposed radially opposite one another adjacent the outlet. The first and second engagement members allow the first and second portions to move axially relative to one another in a first orientation and constrain the first and second portions from moving axially relative to one another beyond a selected position in a second orientation.

[0017] In a representative example, the assembly can include a delivery apparatus including a first shaft and a second shaft disposed over the first shaft, and a compression device, the compression device including a housing disposed over the first shaft and configured to receive a radially expandable and compressible prosthetic valve in a radially expanded state, the housing including a funnel segment extending at least partially along an axial length of the housing and an outlet in communication with the funnel segment, a pusher member having an outer diameter smaller than an inner diameter of the housing such that the pusher member can be driven forward into the housing, and an actuator removably coupled to the pusher member, such that axial forward drive of the actuator relative to the housing drives the prosthetic valve axially through the funnel segment such that at least a portion of the prosthetic valve is radially compressed by engagement with the funnel segment and is led out of the compression device via the outlet. The assembly further includes a loading assembly including a support tube disposed over the second shaft and including a first side and a second side, and a funnel member disposed over a first end portion of the support tube and including a first side and a second side.

[0018] In a representative example, the method may include placing a support tube of a loading assembly over a capsule of a delivery device, the support tube including a first side and a second side, and placing a housing of a compression device over a shaft of the delivery device such that an outlet end portion of the compression device is positioned adjacent to an inlet end portion of the loading assembly, the housing defining a funnel segment extending at least partially along an axial length of the housing and an outlet in communication with the funnel segment. The method may further include inserting the prosthetic valve in a radially expanded state into the inlet end portion of the housing, axially driving the prosthetic valve forward through the funnel segment of the housing and at least partially through the outlet, and placing a funnel member of the loading assembly over at least a portion of the prosthetic valve, the funnel member including a first side and a second side. The method may further include driving the loading assembly axially over the prosthetic valve to radially compress the prosthetic valve and drive the prosthetic valve into a capsule of the delivery device.

[0019] In a representative example, the compression device can include a housing configured to receive a radially expandable and compressible prosthetic valve in a radially expanded state, the housing can include a funnel segment extending at least partially along an axial length of the housing and including a plurality of ribs spaced about a periphery of the housing, the ribs including the funnel segment extending inwardly toward a longitudinal axis of the housing and an outlet in communication with the funnel segment. The compression device can further include a pusher member configured to abut against the prosthetic valve within the housing when the prosthetic valve is received within the housing, the pusher member including a plurality of arms extending from a first end portion, each arm including a seat configured to engage an adjacent end portion of the prosthetic valve, and an actuator coupled to the pusher member. The housing is configured to receive the actuator at a selected angular orientation, and the actuator is configured to be slidably driven forward into the housing at the selected angular orientation such that the prosthetic valve is driven axially through the funnel segment such that at least a portion of the prosthetic valve is radially compressed by engagement with the funnel segment and expelled from the compression device via the outlet.

[0020] In a representative example, the loading device can include a support tube configured to be disposed over a shaft of the delivery device, the support tube including a first side and a second side, a first clamp member removably coupled to a first end portion of the support tube to hold the first side and the second side together, and a funnel member disposed over the second end portion of the support tube, the funnel member configured to be disposed over at least a portion of the prosthetic valve and including the first side and the second side. The loading assembly can further include a second clamp member removably coupled to the first end portion of the funnel member to hold the first side and the second side together. The loading assembly can be configured to radially compress the prosthetic valve through engagement with the funnel member by driving the funnel member axially forward over the prosthetic valve or by driving the prosthetic valve back within the funnel member.

[0021] In another representative example, a compression device may include a housing configured to receive a radially expandable and compressible prosthetic valve in a radially expanded state, a pusher member, and an actuator. The housing may include a funnel segment extending at least partially along an axial length of the housing and an outlet in communication with the funnel segment. The pusher member may be configured to abut against the prosthetic valve within the housing and may have an outer diameter smaller than an inner diameter of the housing such that the pusher member may be driven forward into the housing. The actuator may be removably coupled to the pusher member and may include a base member and one or more elongate guide members extending from the base member, each elongate guide member including a slot extending at least partially along a length of the guide member and a slidable member slidably disposed within the slot and removably coupled to the housing. Axial forward driving of the housing relative to the base member can cause the slidable members to slide within their corresponding slots, whereby insertion of the pushing member into the housing drives the artificial valve axially through the funnel segments, whereby at least a portion of the artificial valve is radially compressed by engagement with the funnel segments and expelled from the compression device via the outlet.

[0022] In another representative example, the compression device can include a housing configured to receive a radially expandable and compressible prosthetic valve in a radially expanded state, an outer shell with the housing disposed therein, an actuator, and a pusher member. The housing can include a funnel segment extending at least partially along an axial length of the housing and an outlet in communication with the funnel segment. The outer shell can have a cylindrical shape and can include a threaded inner surface. The actuator can include a cylindrical extension member having a base and a corresponding threaded outer surface configured to engage the threaded inner surface of the outer shell. The pusher member can be coupled to the base of the actuator and has a plurality of radially extending arms configured to engage the prosthetic valve within the housing. The threaded portions can be configured to translate rotational movement of the actuator into axial forward movement of the pushing member into the funnel segment of the housing, thereby driving the artificial valve axially through the funnel segment, whereby at least a portion of the artificial valve is radially compressed by engagement with the funnel segment and expelled from the compression device via the outlet.

[0023] In yet another representative example, a compression device can include a housing configured to receive a radially expandable and compressible prosthetic valve in a radially expanded state, an actuator, and a pusher member. The housing includes a funnel segment extending at least partially along an axial length of the housing and an outlet in communication with the funnel segment. The actuator includes a base having an opening extending through a thickness thereof, the opening including a threaded inner surface, a threaded member having a threaded outer surface that engages the threaded inner surface of the opening, and one or more extension members coupling the actuator to the housing. The pusher member can be coupled to the threaded member, the threaded member can drive rotationally and axially forward relative to the pusher member, the pusher member configured to abut against the prosthetic valve within the housing. Rotation of the threaded member drives the pusher member axially forward into the funnel segment of the housing, thereby driving the artificial valve axially through the funnel segment, whereby at least a portion of the artificial valve is radially compressed by engagement with the funnel segment.

[0024] In yet another representative example, the compression device may include a housing configured to receive a radially expandable and compressible prosthetic valve in a radially expanded state, an actuator, and a pusher member. The housing may include a funnel segment extending at least partially along an axial length of the housing, and an outlet in communication with the funnel segment. The actuator may include a handle including a lever member configured to drive the actuator member forward when actuated, and a retaining portion extending from the handle and configured to receive the housing, the retaining portion having a first end portion including the retaining member configured to releasably couple the housing. The pusher member may be coupled to the actuator member and configured to abut against the prosthetic valve when the prosthetic valve is disposed within the housing. Actuation of the lever member drives the actuator member forward in an axial direction, which in turn drives the pusher member forward in an axial direction, which drives the pusher member forward into the funnel segment of the housing, thereby driving the prosthetic valve axially through the funnel segment, whereby at least a portion of the prosthetic valve is radially compressed by engagement with the funnel segment.

[0025] In another representative example, a loading assembly for a prosthetic valve can include a support tube positionable around a delivery capsule of a delivery device, the support tube having a proximal end portion and a distal end portion, and a funnel member removably coupleable to the distal end portion of the support tube, the funnel member configured to radially compress the prosthetic valve and guide the prosthetic valve into the delivery capsule when the loading assembly is driven forward over the prosthetic valve or when the prosthetic valve is driven back within the loading assembly.

[0026] The above and other objects, features, and advantages of the present disclosure will become more apparent from the following detailed description, which proceeds with reference to the accompanying drawings. [Brief description of the drawings]

[0027] [Figure 1] FIG. 1 is a perspective view of a compression device, according to an example. [Figure 2A] FIG. 2A is a side cross-sectional view of the compression device of FIG. 1 mounted on an exemplary delivery apparatus. [Figure 2B] FIG. 2B is a cross-sectional side view of another example of a housing in a compression device. [Figure 2C] FIG. 2C is a perspective view of a portion of the housing of FIG. 2B. [Figure 3A] 3A is a perspective view of a housing of the compression device of FIG. 1. FIG. [Figure 3B] 3B is an end view of the housing of the compression device of FIG. 1. FIG. [Figure 4] 4 is a perspective view of a housing of the compression device of FIG. 1. FIG. [Diagram 5] 5 is a perspective view of a retaining ring in the compression device of FIG. 1. FIG. [Figure 6] 6 is a perspective view of a pushing member in the compression device of FIG. 1. FIG. [Figure 7] 7 is a perspective view of a pushing member in the compression device of FIG. 1. FIG. [Figure 8] 8 is an end view of a pusher member in the compression device of FIG. 1. FIG. [Figure 9] FIG. 9 is a perspective view of a housing of the compression device of FIG. 1 with a pusher member disposed therein. [Figure 10] FIG. 10 is a perspective view of an actuator in the compression device of FIG. [Figure 11] 11 is a perspective view of another example of an actuator coupled to a pusher member in the compression device of FIG. [Figure 12] 12 is a side cross-sectional view of the actuator and pusher member of FIG. [Figure 13]13 is a perspective view of another example of an actuator coupled to a pusher member in the compression device of FIG. 1. FIG. [Figure 14] FIG. 14 is a perspective view of the slidable member in FIG. [Figure 15] FIG. 15 is a side view of the actuator and pusher member of FIG. 13 coupled to a housing. [Figure 16] FIG. 16 is a perspective view of another example of a compression device. [Figure 17] FIG. 17 is a perspective view of another example of a compression device. [Figure 18] FIG. 18 is a perspective cross-sectional view of the compression device of FIG. [Figure 19] 19 is a perspective view of the actuator and pusher member of the compression device of FIG. 16. FIG. [Figure 20] 20 is a perspective cross-sectional view of the actuator and pusher member of the compression device of FIG. 16. FIG. [Figure 21] 21 is a perspective view of a shell of the compression device of FIG. 16. FIG. [Figure 22] 22 is a perspective view of the shell and housing of the compression device of FIG. 16. FIG. [Figure 23] FIG. 23 is a side view of another example of a compression device. [Figure 24] 24 is a perspective view of a housing of the compression device of FIG. 23. FIG. [Diagram 25] 25 is a perspective view of the actuator and pusher member of the compression device of FIG. 23. FIG. [Figure 26] FIG. 26 is a perspective view of another example of a compression device. [Figure 27] 27 is a perspective view of an actuator in the compression device of FIG. 26. FIG. [Figure 28] 28 is a side cross-sectional view of the thumbscrew of the actuator of FIG. 27. [Figure 29]29 is a perspective view of the actuator and pusher member of the compression device of FIG. 26. FIG. [Figure 30A] FIG. 30A is a perspective view of another example of a compression device. [Figure 30B] FIG. 30B is a perspective view of another example of a compression device. [Diagram 31] FIG. 31 is a perspective view of another example of a compression device. [Diagram 32] 32 is a perspective view of the extender of the compression device of FIG. 31. FIG. [Diagram 33] 33 is a perspective view of an extender and a pusher member of the compression device of FIG. 31. FIG. [Diagram 34] FIG. 34 is a perspective view of another example of a compression device. [Diagram 35] 35 is a perspective view of the actuator and pusher member of the compression device of FIG. 34. FIG. [Diagram 36] FIG. 36 is a side view of one example of a prosthetic heart valve that may be compressed using any of the compression devices disclosed herein. [Figure 37] 37 is a side cross-sectional view of the distal end portion of one example of a delivery device that may be used to deliver and implant the prosthetic valve of FIG. [Figure 38] FIG. 38 is a perspective view of an example compression device. [Figure 39] FIG. 39 is a perspective view of another example of a compression device. [Diagram 40] FIG. 40 is a perspective view of yet another example of a compression device. [Diagram 41] FIG. 41 is a perspective view of an example compression device. [Diagram 42] FIG. 42 is a perspective view of another example of a compression device. [Figure 43A] FIG. 43A is a perspective view of another example of a compression device, with the housing shown in a bottom view and the actuator shown in a top view. [Figure 43B]FIG. 43B is a perspective view of the compression device of FIG. 43A. [Figure 43C] FIG. 43C is a perspective view of the compression device of FIG. 43A. [Diagram 44] FIG. 44 is a perspective view of another example of a compression device. [Diagram 45] FIG. 45 is a perspective view of another example of a compression device. [Figure 46] FIG. 46 is a perspective view of another example of a compression device. [Figure 47] FIG. 47 is a perspective view of another example of a compression device. [Figure 48] FIG. 48 is a perspective view of another example of a compression device. [Figure 49A] FIG. 49A is a top view of an actuator in a compression device, according to one example. [Figure 49B] FIG. 49B is a perspective view of the actuator of FIG. 49A. [Figure 49C] FIG. 49C is a perspective view of a portion of a housing that forms a compression device with the actuator shown in FIG. 49A. [Figure 50] FIG. 50 is a perspective view of another example of a compression device. [Figure 51] FIG. 51 is a cross-sectional view of another example of a compression device. [Figure 52] FIG. 52 is a perspective view of another example of a compression device. [Diagram 53] FIG. 53 is an exploded perspective view of a loading assembly, according to one example. [Figure 54] 54 is a perspective view of the loading assembly of FIG. 53. FIG. [Figure 55] 55 is a perspective view of the loading assembly of FIG. 53. FIG. [Figure 56] 56 is a perspective view of a clamp member in the loading assembly of FIG. 53. FIG. [Figure 57]57 is a side view of a distal end portion of an exemplary delivery device that may be used with the loading assembly of FIG. 53. [Figure 58] 58 is a side cross-sectional view of a distal end portion of the shaft of the delivery device of FIG. 57 with the loading assembly of FIG. 53 positioned thereon. [Figure 59] 59 is a side view of the distal end portion of the delivery apparatus of FIG. 57 with the loading assembly of FIG. 53 and the prosthetic heart valve of FIG. 36 positioned thereon. [Figure 60] FIG. 60 illustrates an exemplary method for loading the prosthetic heart valve of FIG. 36 into the loading assembly of FIG. [Figure 61] FIG. 61 illustrates an exemplary method for loading the prosthetic heart valve of FIG. 36 into the loading assembly of FIG. [Figure 62] FIG. 62 illustrates an exemplary method for loading the prosthetic heart valve of FIG. 36 into the loading assembly of FIG. [Figure 63] FIG. 63 illustrates an exemplary method for loading the prosthetic heart valve of FIG. 36 into the loading assembly of FIG. [Fig. 64A] FIG. 64A illustrates an exemplary method for loading the prosthetic heart valve of FIG. 36 into the loading assembly of FIG. [Figure 64B] FIG. 64B illustrates an exemplary method for loading the prosthetic heart valve of FIG. 36 into the loading assembly of FIG. [Figure 65] FIG. 65 illustrates an exemplary method for trimming the sheath in the delivery apparatus of FIG. 57 using the trimming guide device of FIGS. [Figure 66] FIG. 66 illustrates an exemplary method for trimming the sheath in the delivery apparatus of FIG. 57 using the trimming guide device of FIGS. [Figure 67] FIG. 67 illustrates an exemplary method for trimming the sheath in the delivery apparatus of FIG. 57 using the trimming guide device of FIGS. [Figure 68]FIG. 68 illustrates an exemplary method for trimming the sheath in the delivery apparatus of FIG. 57 using the trimming guide device of FIGS. [Figure 69] FIG. 69 illustrates an exemplary method for trimming the sheath in the delivery apparatus of FIG. 57 using the trimming guide device of FIGS. [Figure 70] FIG. 70 is a perspective view of a trimming guide device, according to one example. [Figure 71] 71 is a side view of the trimming guide device of FIG. [Figure 72] FIG. 72 is a perspective view of an additional example of a trimming guide device. [Figure 73] FIG. 73 is a perspective view of an additional example of a trimming guide device. [Figure 74] FIG. 74 is a perspective view of another example of a compression device. [Figure 75] FIG. 75 is a perspective view of a housing of the compression device of FIG. [Figure 76] FIG. 76 is a cross-sectional view of the compression device of FIG. [Figure 77] FIG. 77 is a perspective view of a distal end portion of a delivery device, including an example of a holder member. [Figure 78] FIG. 78 is a perspective view of a distal end portion of a delivery device, including an example of a holder member. [Figure 79] FIG. 79 is a perspective view of the holder member of FIGS. [Figure 80] FIG. 80 is a plan view of the holder member of FIGS. [Figure 81] FIG. 81 is a perspective view of a trimming device, according to one example. [Figure 82] FIG. 82 is a perspective view of the trimming device of FIG. 81 disposed on a distal end portion of a delivery apparatus and including a trimmer guide member. [Figure 83]FIG. 83 is a perspective view of the trimming device of FIG. 81 disposed on a distal end portion of a delivery apparatus and including a trimmer guide member. [Figure 84] FIG. 84 is a perspective view of a trimming device according to another example. [Figure 85] FIG. 85 is a perspective view of the trimming device of FIG. 84 showing a distal end portion of a delivery system disposed within the device. [Figure 86] 86 is a perspective view of a blade holder in the trimming device of FIG. 84. FIG. [Figure 87] FIG. 87 is a front view of the rotatable member of the trimming device of FIG. 84 with the door member shown in the open position. [Figure 88] FIG. 88 is a front view of the rotatable members of the trimming device of FIG. 84 with the door member shown in the closed position and the ratchet member removed. [Figure 89] FIG. 89 is a perspective view of a trimming device according to another example, showing a distal end portion of a delivery system disposed within the trimming device. [Figure 90] FIG. 90 is a front view of the rotatable member of the trimming device of FIG. 89 with the door member shown in the open position. [Figure 91] FIG. 91 is a front view of the trimming device of FIG. 89 with the door member shown in a closed position. [Figure 92] 92 is a perspective view of an end portion of the trimming device of FIG. 89. FIG. [Figure 93] FIG. 93 is a perspective view of the trimming device of FIG. 89 showing a distal end portion of the delivery system disposed within the device and showing the second clamping member in an open position. [Figure 94] FIG. 94 is a front view of the rotatable member of the trimming device of FIG. 89 with the blades shown in the retracted position. [Figure 95] FIG. 95 is a front view of the rotatable member of the trimming device of FIG. 89, with the blades shown in the use position. [Figure 96] FIG. 96 is a perspective view of a trimming device according to another example, showing a distal end portion of a delivery system disposed within the trimming device. [Figure 97] FIG. 97 is a perspective view of the distal end portion of the trimming device of FIG. 96, showing the distal end portion of the delivery system disposed within the trimming device and showing the door member in an open position. [Figure 98] FIG. 98 is a perspective view of a trimming device according to another example, showing a distal end portion of a delivery system in an adjacent position relative to the device. [Figure 99] FIG. 99 is a view of the trimming device of FIG. 98 with a distal end portion of the delivery system disposed within the device. [Figure 100] FIG. 100 is a view of the trimming device of FIG. 98 with a distal end portion of the delivery system disposed within the device. [Figure 101] FIG. 101 is a side view of a distal end portion of a delivery system, according to one example. [Figure 102] FIG. 102 is a side cross-sectional view of a distal end portion of the shaft of the delivery device of FIG. 101 with an exemplary loading assembly disposed thereon. [Figure 103] FIG. 103 is a perspective view of the shaft of an exemplary delivery system, showing the outer wall of the shaft through-hole. [Figure 104A] FIG. 104A is a perspective view of the shaft of FIG. 103 with an exemplary support tube disposed thereon, the support tube being shown in cross section. [Figure 104B] FIG. 104B is an enlarged view of a portion of FIG. 104A, showing structural features in cross section. [Figure 105]FIG. 105 is a side cross-sectional view of a shaft in an exemplary delivery system. [Figure 106A] FIG. 106A is a diagram of an exemplary protrusion disposed on a shaft in an exemplary delivery system. [Figure 106B] FIG. 106B is a diagram of an exemplary protrusion disposed on a shaft in an exemplary delivery system. [Figure 107A] FIG. 107A is a diagram of an exemplary protrusion disposed on a shaft in an exemplary delivery system. [Figure 107B] FIG. 107B is a diagram of an exemplary protrusion disposed on a shaft in an exemplary delivery system. [Figure 108] FIG. 108 is a diagram of an exemplary protrusion disposed on a shaft in an exemplary delivery system. [Figure 109] FIG. 109 is a perspective view of a structural member, according to an example. [Figure 110] FIG. 110 is a perspective view of another example of a compression device. [Figure 111] FIG. 111 is a side perspective view of the compression device of FIG. [Figure 112] FIG. 112 is a side elevational view of the compression device of FIG. [Figure 113] FIG. 113 is a front view of the other side of the compression device of FIG. [Fig. 114] FIG. 114 is a plan view of the side of FIG. [Figure 115] 115 is a front view of the engaging member at the side of FIG. 113. FIG. [Fig. 116] 116 is a front view of the engaging member at the side of FIG. 113. FIG. [Figure 117] FIG. 117 is a perspective view of another example of a compression device. [Fig. 118A] FIG. 118A is a perspective view of another example of a compression device. [Fig. 118B]FIG. 118B is a perspective view of another example of a compression device. [Figure 119] FIG. 119 is a perspective view of another example of a compression device. [Figure 120] FIG. 120 is a perspective view of another example of a clamp member. [Figure 121] FIG. 121 is a front view of another example of a clamp member. [Figure 122] FIG. 122 is a perspective view of an exemplary clamp member configured as a loading lock. [Figure 123] FIG. 123 is a perspective view of an exemplary clamping member configured as a support tube lock. [Figure 124] FIG. 124 is a front view of another example of a clamp member. [Fig. 125] FIG. 125 is a perspective view of the prosthetic heart valve of FIG. 36 disposed within the actuator and pusher member of the compression device of FIGS. 74-76. [Fig. 126] FIG. 126 illustrates an exemplary method for loading the prosthetic heart valve of FIG. 36 into the loading assembly of FIG. 53 using the compression device of FIGS. [Figure 127] FIG. 127 illustrates an exemplary method for loading the prosthetic heart valve of FIG. 36 into the loading assembly of FIG. 53 using the compression device of FIGS. [Figure 128] FIG. 128 illustrates an exemplary method for loading the prosthetic heart valve of FIG. 36 into the loading assembly of FIG. 53 using the compression device of FIGS. [Figure 129] FIG. 129 illustrates an exemplary method for loading the prosthetic heart valve of FIG. 36 into the loading assembly of FIG. 53 using the compression device of FIGS. [Fig. 130] FIG. 130 illustrates an exemplary method for loading the prosthetic heart valve of FIG. 36 into the loading assembly of FIG. 53 using the compression device of FIGS. [Fig. 131]FIG. 131 illustrates an exemplary method for loading the prosthetic heart valve of FIG. 36 into the loading assembly of FIG. 53 using the compression device of FIGS. [Fig. 132] FIG. 132 illustrates an exemplary method for loading the prosthetic heart valve of FIG. 36 into the loading assembly of FIG. 53 using the compression device of FIGS. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0028] General Considerations For purposes of this specification, certain aspects, advantages, and novel features of the disclosed examples are described herein. The disclosed methods, devices, and systems should not be construed as limiting in any way. Instead, the disclosure is directed to all novel and non-obvious features and aspects of the various disclosed examples, alone, in various combinations with each other, and in various subcombinations with each other. The methods, devices, and systems are not limited to any particular aspects, features, or combinations thereof, nor do the disclosed examples require the presence of any one or more particular advantages or problems to be solved.

[0029] Although operations in some disclosed examples are described in a particular sequential order for convenience of presentation, it will be understood that aspects of the description encompass permutations unless a particular order is required by specific language set forth below. For example, operations described sequentially may in some cases be permuted or performed simultaneously. Moreover, for simplicity, the accompanying drawings may not show various ways in which the disclosed methods may be used in combination with other methods. Additionally, the description sometimes uses terms such as "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 those skilled in the art.

[0030] All features described herein are independent of one another and may be used in combination with any other feature described herein unless structurally impossible. For example, the elongated guide 608 as shown in Figures 26-27 may be used in combination with any compression device disclosed herein. In another example, the extender 820 as shown in Figures 32-33 may be used in combination with any compression device disclosed herein. Any of the disclosed compression devices may be used in combination with the loading assembly 2400. Any of the disclosed trimming devices may be used in combination with the loading assembly 2400.

[0031] As used in this application and the claims, the singular forms "a," "an," and "the" include the plural unless the context clearly dictates otherwise. Additionally, the term "includes" means "comprises." Furthermore, the term "coupled" generally means to physically, mechanically, chemically, magnetically, and / or electrically couple or connect, and does not exclude the presence of intermediate elements between coupled or associated members, unless specifically stated to the contrary. 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."

[0032] As used herein, the term "proximal" refers to a position, orientation, or portion of a device that is closer to the user and away from the implantation site. As used herein, the term "distal" refers to a position, orientation, or portion of a device that is away from the user and closer to the implantation site. Thus, for example, proximal movement of a device is movement of the device away from the implantation site toward the user (e.g., outside the patient's body), while distal movement of a device is movement of the device away from the user toward the implantation site (e.g., into the patient's body). The terms "longitudinal" and "axial" refer to axes extending proximally and distally, unless expressly defined otherwise. Examples of technologies to be disclosed

[0033] 1-10 illustrate an exemplary system for at least partially compressing prosthetic valves and other compressible implantable medical devices, such as stents, grafts, and the like, and for securing such implantable medical devices to a delivery device. The illustrated system generally includes a compression device 100 and a radially expandable and compressible prosthetic valve 1000 (FIG. 36). The compression device 100 is configured to reduce the diameter of the prosthetic valve 1000 from a fully expanded configuration to a fully or partially radially compressed state for initial coupling to the delivery device. After the prosthetic valve 1000 is coupled to the delivery device, a separate loading assembly (e.g., loading assembly 2400 shown in FIG. 53) can be used to fully compress the prosthetic valve and load it into the capsule or sheath of the delivery device. FIG. 36 illustrates an exemplary prosthetic valve 1000 that may be used with any of the compression devices disclosed herein.

[0034] As mentioned above, the exemplary system shown in Figures 1-10 may further include a delivery device 102, or a portion thereof. With reference to Figure 2A, the delivery device may include, for example, an inner shaft or catheter 104 (such as a guidewire shaft) and an outer sheath 106 (also referred to as a capsule), the delivery device being sized to hold the prosthetic valve 1000 in a radially compressed configuration for delivery into a patient. The prosthetic valve 1000 may include any radially collapsible and expandable prosthetic valve, such as a prosthetic heart valve. The prosthetic valve 1000 may be radially collapsible and expandable between an expanded configuration and a delivery configuration (or any of a variety of configurations in between). The prosthetic valve 1000 may be self-expanding or plastically expandable. A self-expanding valve may have a frame formed from a self-expanding metal (e.g., Nitinol). A plastically expandable valve may have a frame formed from a plastically deformable metal (e.g., stainless steel or a cobalt chromium alloy).

[0035] Although the prosthetic valves shown herein are described as plastically deformable or self-expandable prosthetic valves, it should be noted that the compression devices disclosed herein may be used with any type of prosthetic valve. For example, the compression devices may be used with mechanically expandable prosthetic heart valves (such as those described in U.S. Pat. No. 10,603,165 and International Application No. PCT / US2021 / 052745, each of which is incorporated herein by reference in its entirety) in which the frame is radially expandable via one or more mechanical actuators. The frames of some mechanical valves may include pivotable interfaces between the struts of the frame, while the frames of other mechanical valves may include an integral lattice frame that is expandable and / or compressible by mechanical means. The compression devices described herein can additionally be used with other types of transcatheter prosthetic valves, including balloon-expandable prosthetic heart valves in which the frame is formed from a plastically deformable material, such as those disclosed in U.S. Pat. No. 9,393,110, U.S. Pat. No. 11,096,781, and U.S. Patent Publication No. 2019 / 0365530, each of which is incorporated by reference in its entirety.

[0036] After the prosthetic valve 1000 is coupled to the delivery apparatus 102, the prosthetic valve 1000 can be removed from the compression device 100. In some examples, the prosthetic valve 1000 and the delivery apparatus 102 can be driven forward through an outlet of the compression device 100, with the compression device 100 remaining positioned around a portion of the delivery apparatus 102 that is distal to the prosthetic valve 100. In other examples, the compression device 100, or components thereof, can be configured to separate into pieces or open, such as in a clamshell-like manner, so that the compression device 100 can be laterally removed from the delivery apparatus 102 and prosthetic valve 1000, as described further below. After the prosthetic valve 1000 is removed from the compression device 100, the prosthetic valve 1000 can be further compressed and loaded into the delivery apparatus 102, such as by using a loading assembly.

[0037] 1, the exemplary compression device 100 may generally include a housing 108, an actuator 110, and a valve holder or pusher member 112 (also referred to as a seat member) that is removably coupled to the actuator 110. The actuator 110 and the pusher member 112 may be axially movable relative to the housing 108. In some examples, the housing 108 may include a first housing component or side 114 (see FIG. 4) and a second housing component or side 114 (see FIG. 4) that are separable from one another, and in other examples, the housing 108 may be formed as a unitary member.

[0038] 2A, the housing 108 can include a distal or inlet end portion 116 including an opening or inlet 118 and a proximal or outlet end portion 120 including an opening or outlet 122. The housing 108 can have a generally cylindrical shape with an inner bore defining a tapered or funnel segment 124 tapered from the inlet 118 to the outlet 122 and terminating at the outlet. In certain examples, the funnel segment 124 can be defined by a number of rib members 128 extending inwardly from an inner surface of the housing, as described in more detail below. The funnel segment 124 can taper from a first larger diameter adjacent the inlet 118 to a second smaller diameter adjacent the outlet 122. The diameter of the outlet 122 can be approximately the same as the defined diameter for the prosthetic valve 1000 in its radially compressed delivery configuration. In some examples, such as those shown in Figures 2-4, the outlet 122 can be flush with / defined by the outer rim portion 126 at the outlet end portion 120 (Figure 4), while in other examples, the outlet 122 can be recessed with respect to or extend beyond the rim portion 126.

[0039] 3A, the funnel segment 124 can include a plurality of circumferentially spaced apart ramp members and / or a plurality of ribs 128, where the ramp members and / or ribs 128 extend longitudinally along at least a portion of the length of the housing 108 and extend radially inward toward a longitudinal axis A (FIG. 4) extending through the housing 108. A radially inward facing surface 129 of the rib 128 can define the funnel segment 124. The thickness of the rib 128 (the thickness being the dimension extending from the inner wall 130 of the housing 108 toward the longitudinal axis A) can increase along its length from a thinner thickness adjacent the inlet end portion 116 to a thicker thickness adjacent the outlet end portion 120. In other words, the radial distance r measured between the axis A and the inner surface 129 of the rib 128 can decrease in a direction from the inlet end portion 116 toward the outlet 122. Thus, the diameter of funnel segment 124 can decrease in a direction toward outlet 122. Ribs 128 function to prevent or at least minimize axial deformation of the prosthetic valve (such as prosthetic valve 1000 shown in FIG. 36) upon radial compression and / or to aid in alignment of connecting features of the prosthetic valve with engaging features of the delivery device. As the prosthetic valve advances along funnel segment 124 (e.g., when pushed by pusher member 112), tapered ribs 128 progressively compress the prosthetic valve into a compressed configuration.

[0040] 2A, in some examples, the funnel segment 124 can define a first tapered section 132 and a second tapered section 134 that can compress the prosthetic valve at different rates based on different taper angles for the two sections. In the illustrated example, for example, the first section 132 is tapered at a smaller angle α relative to the longitudinal axis A as compared to the angle β for the second section 134. For example, in some particular examples, each angle can be between 0° and 90°. In particular examples, the angle α can be between 1° and 90°, between 1° and 70°, between 1° and 60°, between 1° and 40°, between 1° and 30°, between 1° and 20°, between 5° and 30°, between 5° and 20°, less than 40°, less than 30°, less than 20°, etc. In the illustrated example, the angle α can be 15°. In certain examples, the angle β can be between 10° and 90°, between 20° and 70°, between 30° and 70°, between 30° and 60°, between 40° and 60°, less than 90°, less than 70°, less than 60°, less than 50°, etc. In the illustrated example, the angle β can be 50°. Thus, the first section 132 can begin to radially compress the prosthetic valve from a fully expanded diameter to a partially compressed diameter, where the prosthetic valve is compressed from the partially compressed diameter to a further partially compressed diameter after the prosthetic valve is introduced into the second section 134 for attachment to and / or loading into a delivery device (e.g., delivery device 102). In other examples, the first section 132 can be tapered at the same angle as the second section 134 or at a greater angle than the second section 134.

[0041] In other examples, funnel segment 124 can define one or more additional tapered sections that can compress the prosthetic valve at different rates based on the different taper angles of each section. For example, FIGS. 2B-2C illustrate funnel segment 124 having four tapered sections 125a, 125b, 125c, and 125d. First section 125a can be tapered at a first angle γ, second section 125b can be tapered at a second angle δ, third section 125c can be tapered at a third angle ε, and fourth section 125d can be tapered at a fourth angle θ, relative to a line parallel to longitudinal axis A of housing 108. In the illustrated example, second angle δ can be greater than first angle γ and third angle ε, such that second section 125b forms a step between first section 125a and third section 125c. In the illustrated example, the fourth angle θ can be greater than the second angle δ, which can be greater than the third angle ε, which can be greater than the first angle γ. Thus, the sections 125a-125d can compress the prosthetic valve 1000 from a fully expanded diameter to a partially compressed diameter as the prosthetic valve advances through the housing 108. In other examples, one or more sections can have the same angle. For example, in some particular examples, each angle can be between 0° and 90°. In particular examples, the angle δ can be between 1° and 90°, between 1° and 75°, between 1° and 65°, between 1° and 45°, between 1° and 35°, between 1° and 25°, between 5° and 35°, between 5° and 25°, less than 45°, less than 35°, less than 25°, etc. In the illustrated example, the angle δ can be 45°. In particular examples, angle γ can be between 1° and 90°, between 1° and 70°, between 1° and 50°, between 1° and 40°, 10° or less, 20° or less, 30° or less, etc. In the illustrated example, angle γ can be 7° or less. In particular examples, angle ε can be between 1° and 90°, between 1° and 50°, between 1° and 40°, between 1° and 30°, between 1° and 20°, 10° or less, 20° or less, 30° or less, etc.In the illustrated example, the angle ε can be 15° or less. In certain examples, the angle θ can be 1° to 90°, 1° to 75°, 1° to 65°, 1° to 55°, 1° to 45°, 60° or less, 50° or less, 40° or less, etc. In the illustrated example, the angle θ can be 55° or less. In the illustrated example, the angle γ can be 10° or less. In some examples, the first angle γ and the second angle δ can be configured to follow the contour of the prosthetic valve 100. Thus, the first section 125a and the second section 125b can be configured to receive the prosthetic valve 1000 before compression, and the prosthetic valve 1000 can be compressed by the third angle ε and the fourth angle θ as the prosthetic valve advances through the third section 125c and the fourth section 125d. Such a configuration advantageously allows the prosthetic valve 1000 to be easily inserted into the funnel segment 124.

[0042] With reference to FIG. 4, each side 114 of the housing 108 may include a semi-cylinder such that when placed together they form a generally cylindrical or tubular shape. Each of the sides 114a, 114b may include an engagement feature that allows the sides to be coupled together. For example, as shown in FIG. 4, the first side 114a may include one or more recesses 136, such as diametrically opposed recesses formed in a longitudinal edge of the first side 114a, and the second side 114b may include a corresponding protrusion or tab 138 extending from a longitudinal edge of the second side 114b. As shown, the protrusion 138 may seat within the recess 136 when the sides 114 are coupled together.

[0043] The first side 114 and the second side 114 can be held or locked together in an assembled state when the prosthetic valve is compressed, and then can be separated from one another to facilitate removal of the compression device 100 from the delivery apparatus 102 after the prosthetic valve is loaded onto the delivery apparatus. As shown in FIG. 1 , the first side 114 and the second side 114 can be coupled via a retaining member or ring 140, which can surround both sides 114 and can releasably hold both sides 114 together.

[0044] 3A, the housing 108 can further include one or more alignment features 131 disposed on an inner surface 130 of the housing 108. The alignment features 131 can be configured as protrusions or nodules shaped to guide and / or orient a portion of the prosthetic valve to aid in alignment with a connecting feature of the prosthetic valve (e.g., the enlarged end portion 1014 of the arm 1012 shown in FIG. 36) and an engagement feature of the delivery device.

[0045] 5, the retaining member 140 can include an inner annular surface 146 that can be sized to slide over an outer surface 144 (FIG. 4) of the housing 108 and can be sized to form a frictional engagement, such as with the outlet end portion 120 of the housing side 114, such that the retaining member 140 can hold the sides 114 together during use, but can be easily removed by a user when it is desired to disassemble the housing assembly 108 and remove it from the delivery device 102. In another example, the retaining ring 140 can be disposed on the inlet end portion 116 of the housing 108. The side 114 can include one or more tabs 142 (see, e.g., FIG. 4) that are configured to engage the retaining member 140 and constrain the retaining member 140 from moving along the outer surface of the housing 108 beyond a selected point. In some examples, the retaining ring 140 can include one or more recesses 148 that are configured (e.g., sized and shaped) such that the tabs 142 can seat within the recesses 148. The retaining member 140 can include a gripping interface 150 for easy gripping and use by a user. The gripping interface 150 can include, for example, a plurality of circumferentially spaced ridges 152. Further details regarding the housing and the retaining member can be found, for example, in U.S. Pat. No. 10,639,147, which is incorporated herein by reference in its entirety.

[0046] In other examples, the sides 114 can be removably coupled to one another using a variety of alternative or additional techniques or mechanisms, for example, the sides can be configured to form a snap-fit ​​connection or each side can include integral engagement features configured to engage with corresponding engagement features (e.g., a bayonet mount) on the other side. In yet other examples, the housing 108 can be a unitary component configured as a cylindrical housing component or housing member rather than multiple separable components.

[0047] As discussed above, the compression device 100 may further include a valve holder or pusher member 112 that is removably coupleable to the actuator 110. With reference to Figures 6-8, the pusher member 112 may include a generally cylindrical or tubular body or stem 154 that includes an internal bore 156, and a retention portion 158 that includes a plurality of circumferentially spaced radially extending members, referred to herein as arms 160. The arms 160 may be configured to be slidably disposed between the ribs 128 of the housing 108, as shown in Figure 9, such that when the pusher member 112 is axially actuated relative to the housing 108, the arms 160 move and / or slide through the gaps / slots 127 defined between the ribs 128. The pushing member 112 can have a smaller outer diameter D1 (FIG. 7) as compared to an inner diameter D2 (FIG. 3B) defined by an inner surface 130 of the housing 108 in the gaps between the ribs 128 such that the pushing member 112 can be positioned inside the housing 108. In certain examples, the gaps / slots 127 can also facilitate the insertion of a tool into the funnel portion to guide the implant (e.g., a frame of the implant) and prevent the implant from getting caught on the inner edge of the funnel portion as the implant is compressed.

[0048] The stem 154 can have a first end portion 162 having a first diameter and a second end portion 164 having a second diameter smaller than the first diameter. The second end portion 164 can be sized to extend into a portion of the actuator 110. The arms 160 can extend from the first end portion 162. Each arm 160 can have a substantially triangular base portion 166 and a seat 168, where the seat 168 can include, for example, a first wall 170 and a second wall 170 defining a recess or channel 172 therebetween. Thus, in the illustrated example, the pusher member 112 can include a plurality of seats 168 arranged circumferentially about the first end portion 162 with the channel 172 open in the advancement direction of the pusher member during a valve compression movement. The seat 168 can be configured to retain or engage a portion of the prosthetic valve (e.g., anchor 1010 of the prosthetic valve 1000 shown in FIG. 36 ), for example, to prevent the prosthetic valve from being displaced relative to the pusher member 112 and / or to align the portion of the prosthetic valve relative to the ribs 128. For example, the anchor 1010 can be seated within a channel 172 of the seat 168. As seen most clearly in FIG. 8 , the seat 168 can be tapered from a first width / thickness adjacent a radially outer edge of the pusher member 112 (e.g., an edge at a radially outermost end of the seat 168) to a second width / thickness, less than the first thickness, adjacent the stem 154 to generally correspond to the shape of the space between the ribs 128 of the housing 108.

[0049] The second end portion 164 of the stem 154 can include one or more resilient locking features 174 (e.g., in the illustrated example, two diametrically opposed locking features) configured to releasably couple the pusher member 112 to the actuator 110 such that the actuator 110 can be used to drive the pusher member 112 (and thus the prosthetic valve) forward within the housing 108. For example, in the illustrated example, the locking features 174 are configured as resilient latch members having a protrusion or lip 176 that can engage with a corresponding feature (e.g., an aperture or ledge) in the actuator 110. In the example shown in FIGS. 1-10, the actuator 110 includes one or more apertures 178 ( FIG. 10 ) that can engage with the locking features 174. The locking feature 174 can bend inwardly when the second end portion 164 of the pushing member 112 is driven forward into the inner bore 180 of the actuator 110 and can bend outwardly after being introduced into the opening 178, thereby connecting the pushing member 112 and the actuator 110 via a snap-fit ​​connection.

[0050] 10, the actuator 110 can include a gripping portion or base 182 from which can extend one or more extension portions / members 184, 186. The extension members can include a central extension member 184 (which can include corresponding locking feature(s), such as aperture 178), and one or more guide members, referred to herein as linear guide members 186 (e.g., three linear guide members in the illustrated example). The central extension member 184 can be configured as a cylindrical projection / tube having an internal lumen or bore 180, and the linear guide members 186 can be elongated rectangular projections extending from the base 182 and arranged circumferentially around the central extension member 184. The linear guide member 186 may taper from a first thickness adjacent a radially outer edge of the actuator 110 to a second thickness, less than the first thickness, along a radially inner edge of the linear guide member adjacent the central extension member 184 to generally correspond to the shape of the spaces located between the ribs 128 of the housing 108. A user may grasp the base 182 and apply a pushing force to the actuator 110 to push the pushing member 112 into the housing 108, as represented by arrow 188 in FIG. 1. In some examples, the base 182 may include a gripping interface similar to the gripping interface 150 of the retaining ring 140. As seen most clearly in FIG. 2, in some examples, the base 182 may include a recess 190 extending into the thickness of the base 182.

[0051] In the illustrated example, compression device 100 is shown with components having a substantially circular cross-section, although in other examples, the components can have any of a variety of cross-sectional shapes (e.g., square, rectangular, oval, triangular, etc.).

[0052] In use, the compression device 100 can be used to compress a prosthetic valve (e.g., the prosthetic valve 1000 shown in FIG. 36 ) in the following exemplary manner: The prosthetic valve 1000 can be inserted into the housing 108. The pusher member 112 and the actuator 110 can be aligned with the prosthetic valve 1000 to engage adjacent end portions of the prosthetic valve 1000. As shown in FIG. 2 , the housing 108, pusher member 112, and actuator 110 can be coaxially positioned about the shaft 104 of the delivery apparatus 102. The actuator 110 (and thus the pusher member 112) can be driven axially forward into the housing 108 by a user, such as by axially pushing the housing and actuator together. When the actuator 110 is driven forward relative to the housing 108, the pusher member 112 advances into the housing 108, which forces the prosthetic valve 1000 through the funnel segment 124 of the housing 108 toward the outlet 122. When the prosthetic valve 1000 is forced through the funnel segment 124, the prosthetic valve is at least partially radially compressed and pushed outwardly through the outlet 122.

[0053] In the examples of FIGS. 1-10, the actuator and pushing member are driven into the housing by an axial force applied to the actuator by a user (e.g., by hand or using a pressing device such as a vice) without significant rotation of the actuator relative to the housing. In certain examples, the actuator's guide member 186 can be inserted into a channel located between the housing's ribs 128 to prevent or substantially prevent the actuator from rotating relative to the housing as the valve is compressed (e.g., the housing and actuator rotate relative to each other by 10° or less, such as by 5° or less, as they are driven forward together). In other words, the guide member can maintain angular alignment between the housing 108 and the actuator 110 during the compression operation. In some examples, the prosthetic valve 1000 can be pushed directly from the compression device 100 into a sheath of the delivery apparatus (such as the sheath 106 shown in FIG. 2). In other examples, the prosthetic valve 1000 can be coupled to a valve retaining member, such as the valve retaining member 1110 of the delivery device 1100, and a separate loading assembly (such as the loading assembly 2400 shown in FIG. 53) can be used to compress the prosthetic valve 1000 into a fully compressed configuration and loaded into the sheath / capsule of the delivery device. This additional compression loading step is described in further detail with respect to FIGS. 60-69.

[0054] In some examples, the actuator 110 and / or the pusher member 112 can further include an engagement mechanism configured to releasably engage with a corresponding engagement mechanism on the housing 108 such that the actuator 110 (and / or the pusher member 112) and the housing 108 can be locked together after the prosthetic valve 1000 reaches a selected compressed configuration (e.g., partially compressed or fully compressed). This allows a user to release the actuator 110 without the resilient spring force of the prosthetic valve 1000 pushing the pusher member 112 out of the housing 108, allowing the prosthetic valve to resiliently return to the uncompressed configuration or to the partially compressed configuration. For example, the linear guide member 186 of the actuator 110 can include one or more resilient latches (similar to the latch 174 described above) configured to engage with one or more corresponding openings in the housing 108 to lock the housing and the actuator together at a selected position (e.g., when the prosthetic valve is partially or fully compressed). In other examples, various other types of engagement mechanisms can be used. In some examples, the housing 108 and the actuator 110 can be locked together at a selected position such that the prosthetic valve is disposed within the outlet 122 (in other words, the prosthetic valve has only advanced partially through the outlet). Such a configuration allows a user to release the compression device 100 to engage the connection features of the prosthetic valve with the engagement features of the delivery apparatus without the prosthetic valve elastically expanding to push the pusher member 112 out of the inlet end portion 116.

[0055] Any or all of the compression devices disclosed herein may advantageously allow for a single operator to operate the compression device and may allow for a repeatable and predictable procedure for compressing and loading the prosthetic valve / coupling the prosthetic valve to the delivery device. Some examples of the prosthetic valve may include a connection feature that forms a detachable connection to an engagement feature of the delivery device (the connection feature is located at an end of the prosthetic valve opposite the end that engages the pusher member) (see, for example, the connection arm 1012 of the prosthetic valve 1000, as described in more detail below). In certain examples, the connection feature of the prosthetic valve may be radially compressed while maintaining rotational alignment with the engagement feature of the delivery device. A compression device such as device 100 allows a single operator to control the compression of the prosthetic valve while maintaining rotational alignment of the connection feature of the prosthetic valve with the engagement feature of the delivery device. As the prosthetic valve is driven forward from the outlet 122 of the compression device 100, the operator may connect the connection feature of the prosthetic valve to the engagement feature of the delivery device.

[0056] In some examples, such as the example shown in FIG. 2, the prosthetic valve can be driven forward through the outlet 122 of the compression device 100 and into the sheath 106 of the delivery apparatus 102. The sheath 106 can be a tubular structure configured to house the prosthetic valve in a delivery configuration. The compression device 100 can then be removed from the delivery apparatus 102 by sliding the compression device 100 distally (in the direction of arrow 191) off the inner shaft 104 or by removing the retaining ring 140 to separate the sides 114 of the housing 108. The pusher member 112 and actuator 110 can have sufficiently large inner bores such that they can be slid out of the delivery apparatus 102, for example, by sliding them distally relative to the inner shaft 104 until they are removed from the distal end of the delivery apparatus.

[0057] In other examples, such as that described with respect to FIGURE 37, the prosthetic valve may be driven forward through outlet 122 of compression device 100 and coupled to a valve retaining member (e.g., member 1110 of delivery apparatus 1100). After such coupling, compression device 100 can be removed from the delivery apparatus (e.g., by sliding compression device 100 distally (in the direction of arrow 191) off inner shaft 104 or by removing retaining ring 140 to separate sides 114 of housing 108), and a separate compression loading assembly (e.g., loading assembly 2400) can be used to drive the prosthetic valve forward into the capsule / sheath of the delivery apparatus.

[0058] After the prosthetic valve 1000 is loaded into the delivery device 102, the delivery device 102 may be inserted into the patient's vasculature and used to percutaneously deliver the prosthetic valve 1000 to a desired implantation location using conventional techniques. The distal end of the delivery device 102 may be inserted into another device, such as an introducer sheath, already inserted into the patient to facilitate insertion of the delivery device 102 into the patient.

[0059] In some examples, a system including a compression device (e.g., compression device 100), a delivery apparatus 102, and a prosthetic valve (e.g., prosthetic valve 1000) can be packaged and shipped from a manufacturer to an end user with the prosthetic valve preloaded inside the fully assembled compression device coaxially mounted onto the delivery apparatus. In some examples, the system can further include a sterile package that contains the compression device mounted on a distal end portion of the delivery instrument and the prosthetic valve preloaded therein, and also contains the entire delivery apparatus or only the distal end portion of the delivery apparatus with the compression device and prosthetic valve mounted thereon. In other examples, the system can further include another device, such as an introducer sheath, to aid in inserting the delivery apparatus 102 into the patient after the prosthetic valve has been loaded into the sheath 106. In some examples, the system can further include a compaction loading assembly (e.g., compaction loading assembly 2400 shown in FIG. 53) packaged with other components.

[0060] In some examples, the prosthetic valve (such as the prosthetic valve 1000) can be in a partially compressed configuration before being placed inside the compression device 100 (or any other compression device disclosed herein). For example, the prosthetic valve can be pre-compressed to the partially compressed configuration using a separate compression tool before assembly into the compression device 100. In the partially compressed configuration, the prosthetic valve has an outer diameter between the outer diameter in the expanded configuration and the outer diameter in the delivery configuration. In some examples, the prosthetic valve can have an outer diameter in the partially compressed configuration that is closer to the outer diameter in the delivery configuration than the outer diameter in the expanded configuration. For example, the partially compressed prosthetic valve 1000 can be compressed about 75% from the expanded configuration to the delivery configuration. The compression device 100 can also be configured to compress the prosthetic valve from the expanded configuration to the delivery configuration without initially pre-compressing the prosthetic valve to an intermediate partially compressed configuration.

[0061] 11-12 illustrate another example actuator 200 that may be used in place of or in addition to the actuator 110 described above. The actuator 200 may include a base plate / base member 202 and a first extension member / portion 204 extending axially from a first surface 210 of the base member 202, where the first extension member 204 includes one or more apertures 206 configured to engage the resilient locking feature 174 of the pusher member 112. The actuator 200 may further include a second extension member / portion 208 extending from the first surface 210 and positioned coaxially about the first extension member 204. Thus, in the illustrated example, the first extension member 204 may be configured as an inner extension member and the second extension member 208 may be configured as an outer extension member disposed about an outer periphery of the base member 202. In certain examples, the inner diameter of the second extension portion 208 can be greater than the outer diameter of the housing 108. In the example shown in Figures 11-12, each extension member 204, 208 can be a cylindrical / tube-shaped extension member that includes a corresponding inner bore 212 (Figure 12), 214, respectively. In other examples, the extension members 204, 208 can have any of a variety of other cross-sectional shapes, such as square, rectangular, oval, triangular, etc.

[0062] 12, the first cylindrical extension member 204 can have a height H1, as measured relative to the first surface 210, that is less than the height H2 of the second cylindrical extension member 208. The pusher member 112 can be removably coupled to the first cylindrical extension member 204 in the same manner as described above with respect to the central portion 184. In some examples, such as the illustrated example, the first end portion 162 of the pusher member 112 can extend beyond the first / open end portion 216 of the second cylindrical extension member 208. As shown, the second surface 218 of the base member 202 can include a recess 220, such as a hemispherical recess. The recess 220 can provide an ergonomic surface for a user to place a finger on the actuator 200 to drive the actuator 200 forward.

[0063] The actuator 200 can be used in combination with the pusher member 112 and the housing 108 to compress a prosthetic valve (e.g., the prosthetic valve 1000) in the same manner as described above with respect to the actuator 110. For example, the housing 108 can be at least partially received within the second cylindrical extension 208 when the actuator 200 and the housing 108 are driven forward together. Such a configuration can advantageously center the pusher member 112 along the longitudinal axis A (FIG. 2B) of the housing such that the pusher member 112 is aligned with the prosthetic valve when compressed.

[0064] 13-15 illustrate another example actuator 300 that may be used in place of or in addition to the actuator 110 described above. The actuator 300 may be similar to the actuator 110 described above (e.g., including the base 182, the central extension member 184 having the opening 178, and the linear guide member 186), except that the actuator 300 further includes a guide member, such as a guide 306.

[0065] The guides 306 may be configured as elongate members coupled to and extending from the base portion / member 302. Each guide 306 may include a first end portion 308 and a second end portion 310 adjacent the base member 302. The second end portion 310 may be removably coupled to the base member 302 via a coupling portion configured as a bracket 312 having an opening sized to receive the base member 302 therein. One or more openings 314 may be disposed within the second end portion 310 such that a fastener may extend through the opening to couple each guide 306 to the base member 302. Each of the guides 306 may include an elongate opening or slot 316 extending at least partially along the length of the guide 306.

[0066] The actuator 300 may further include one or more slidable members 318 (also referred to as spacer members) paired with each guide 306. With reference to FIG. 14, the slidable members 318 may include a main portion 320 and a protruding portion or projection 322. The projections 322 may be sized to extend into and seat within the slots 316 of the respective guides 306, as shown in FIG. 13, such that the slidable members 318 may slide axially relative to the guides 306. Each slidable member 318 may include an opening or aperture 324 within which a fastener may be disposed to couple the slidable member 318 to the housing 108, as shown in FIG. 15. For example, an end of the fastener may engage against the exterior surface 144 of the housing 108 and / or the fastener may extend into a corresponding opening in the exterior surface 144 of the housing 108. As shown in FIG. 13, each guide 306 and slidable member 318 may have a curved cross-sectional shape, such as to correspond to the curved circumference of the housing 108 .

[0067] 13-15 , in the illustrated example, the actuator 300 can have three guides 306 spaced apart from one another around the periphery of the base member 302. In other examples, the actuator 300 can have more or fewer guides 306, which can be spaced apart at any location and / or interval around the periphery of the base member 302.

[0068] In use, after the prosthetic valve 1000 is inserted into the housing 108, the actuator 300 can be aligned with the housing 108 such that the slidable member 318 is disposed adjacent an outer surface of the housing 108 and the pusher member 112 engages an adjacent end portion of the prosthetic valve 1000. Once aligned, a fastener can be fastened through an aperture 324 in the slidable member 318 to couple the actuator 300 to the housing 108. When a user applies a force to the actuator (e.g., a pushing force), the housing 114 and actuator 300 move toward each other causing the protrusion 322 of the slidable member 318 to slide / move along the slot 316 and driving the pusher member 112 forward axially into the housing 108. The pusher member 112 can continue to advance through the housing 108, thereby driving the prosthetic valve 1000 forward through the housing 108. The protrusions of the slidable members 318, which move along the slots of the guide members, can maintain the angular orientation of the housing and actuator as they are pressed together and can prevent them from rotating relative to one another. As the prosthetic valve 1000 is pushed through the funnel segment 124, it is radially compressed and is pushed outwardly through the outlet 122. The prosthetic valve 1000 can then be coupled to the valve retaining member 1110 of the delivery apparatus 1100, as described in more detail with respect to FIG. 37, or can be loaded directly into the sheath of the delivery apparatus, as described above with respect to the compression device 100.

[0069] In some examples, the guide 306 can further include an engagement or locking mechanism configured to lock the slide member 318 against movement relative to the slot 316 after the prosthetic valve 1000 reaches a fully compressed position (e.g., after the pusher member 112 is driven fully forward into the housing 108), thereby allowing a user to release the actuator 300 without the resilient spring force of the prosthetic valve 1000 forcing the pusher member 112 out of the housing (which can allow the prosthetic valve to resiliently return to an uncompressed or partially compressed configuration). For example, the slot 316 can include one or more latches or tabs (e.g., angled teeth) that allow movement of the protrusion 322 past the tab in a first direction (e.g., an orientation that advances the pusher member 112 into the housing 108) and prevent movement of the protrusion 322 past the tab in a second direction opposite the first direction (e.g., an orientation that retracts the pusher member 112 from the housing 108). In another example, the guide 306 can include one or more set screws configured to allow a user to "pause" the compression procedure at any point. Set screws in the apertures 324 can also be used for this purpose, and / or the guide member can include any of a variety of other fastening means, including detents, cam lobes, etc., to create discrete increments of travel along the guide member.

[0070] 16-22 illustrate another example compression device 400. The compression device 400 may generally include a housing 108 (as described above), an outer housing or shell 402, and an actuator 404 having a pusher member 112 (as described above). As shown in FIG. 18, the housing 108 may be disposed within the outer shell 402. A portion of the actuator 404 may be received between an inner surface 406 of the shell 402 and an outer surface 144 of the housing 108 and may be driven forward, such as by threads on the outer surface of the actuator 404 and complementary threads on the inner surface of the shell 402.

[0071] 19-20, the actuator 404 can include a base 408 and an extension 410 extending from the base 408. The extension 410 can be configured as a cylindrical extension defining an inner bore 412. An outer surface of the extension 410 can include a threaded portion 414 (e.g., external threads) configured to engage a corresponding threaded portion 416 (e.g., internal threads) disposed on the inner surface 406 of the shell 402.

[0072] The base 408 may include a gripping interface 418 for easy gripping and use by a user. The gripping interface 418 may include, for example, a plurality of circumferentially spaced ridges 420. As shown in FIG. 20, the base 408 may also include an opening or aperture 422 into which the second end portion 164 of the pushing member 112 may extend. The aperture 422 may be surrounded by an annular surface / shoulder / flange, hereinafter referred to as a shelf 424. The pushing member 112 may be removably coupled to the base 408 via a resilient locking feature 174. For example, as described above, the locking feature may be a resilient latch having a lip 176 (see, for example, FIG. 7). The locking feature 174 may flex inwardly when the second end portion 164 is inserted into the opening 422 and then resiliently return so that the lip 176 may engage against the ledge 424, thereby forming a snap-fit ​​connection between the base 408 and the pusher member 112. The connection between the pusher member 112 and the actuator 404 may be configured to allow rotation of the actuator 404 without causing a corresponding rotation of the pusher member 112 (e.g., when the arm 160 of the pusher member 112 is located between the ribs 128 of the housing portion). In other words, when the actuator 404 rotates, the pusher member 112 moves axially with the actuator 404 but does not rotate due to the lip 176 being configured to slip or rotate relative to the ledge 424. The base 408 may further include a recess 426 into which the second end portion 164 of the pusher member 112 may extend when the pusher member and actuator are releasably coupled to one another. The recess 426 may be sized to allow a user access to the resilient locking feature 174 to remove the pusher member 112 from the base 408.

[0073] 21, in the illustrated example, the shell 402 can include a first side 428 and a second side 428 that are separable from one another, similar to the first side 114 and the second side 114 of the housing 108. In other examples, the shell 402 can have three or more separable portions or can be formed as a unitary member. The shell 402 can include an inlet end portion 430 and an outlet end portion 432. The outlet end portion 432 can include an opening or outlet 434 (FIG. 17) configured to align with the outlet 122 of the housing 108 when the housing is disposed within the shell. As shown in FIG. 17, the outlet 434 can have a larger diameter than the outlet 122 of the housing 108, such that, for example, the sheath 106 of the delivery device 102 can abut directly against the outlet end portion of the housing and surround the outlet 122.

[0074] The shell 402 can have a generally cylindrical shape with an internal bore. As described above, the inner surface 406 of the shell 402 can include a threaded portion 416 configured to engage with a corresponding threaded portion 414 of the actuator 404. In the illustrated example, each side 428 of the shell 402 can include a semi-cylinder such that when placed together they form a generally cylindrical or tubular shape. The first side 428 and the second side 428 can be coupled to one another via a retaining member or ring 438 (e.g., similar to the retaining ring 140 of the housing 108), which can surround the sides 428 and releasably hold the sides 428 to one another (FIGS. 17 and 18). The retaining member 438 can be sized to slide over and form a frictional engagement with the proximal end portions of the housing sides 428 (e.g., axially aligned with the outlet 434), thereby retaining the housing sides 428 in the assembled position.

[0075] 21 , each side 428 of the shell 402 may include one or more alignment features 440 configured to prevent or mitigate rotation of the housing 108 relative to the shell 402 when the housing 108 is received within the shell 402. In the illustrated example, each alignment feature 440 may be a protrusion disposed on an inner surface of the shell 402 and extending toward the inlet 436. The alignment features 440 may have a wedge shape tapered from a first width at a radially outer end 442 to a smaller second width at a radially inner end 444 such that the alignment features 440 may extend into corresponding recesses 192 ( FIG. 4 ) in the outlet end portion of the housing 108. The recesses 192 may be defined between and / or by the ribs 128 (e.g., may extend into a hollow interior of the ribs 128). As shown in FIG. 22, when the housing 108 is disposed within the shell 402 and aligned with the alignment feature(s), a circumferentially extending space S can be defined between the outer surface 144 of the housing 108 and the inner surface 406 of the shell 402. As shown in FIG. 18, the threads of the actuator extension 410 can engage the threads of the shell 402, thereby allowing the actuator 404 to advance within the space S, thereby driving the pusher member 112 forward into the housing 108. Thus, the actuator 404 is not coupled to the housing 108 (including the valve compressing funnel segment 124), but rather the inner surface 446 ( FIG. 20 ) of the actuator extension 410 can move axially relative to the outer surface 144 of the housing 108 when the actuator 404 and shell 402 are threadedly engaged together.

[0076] In use, the housing 108 can be placed within the shell 402 such that it engages the alignment features 440, and the prosthetic valve 1000 can be inserted into the housing 108. The pusher member 112 can be aligned with the prosthetic valve 1000 (e.g., between the ribs 128 of the housing 108) such that it engages an adjacent end portion of the prosthetic valve 1000. Once aligned, the extension portion 410 of the actuator 404 can be inserted into the space S, thereby engaging the threaded portion 414 of the actuator with the threaded portion 416 of the shell 402. When the actuator 404 is driven in rotation, the threaded portions 414, 416 translate the rotation into axial movement (e.g., translation / pushing) to drive the pusher member 112 axially forward into the housing 108. The actuator 404 can continue to advance relative to the shell 402, which drives the pusher member 112 forward, thus pushing the prosthetic valve 1000 through the housing 108. As the prosthetic valve 1000 is pushed through the funnel segment 124, it is radially compressed and is pushed outwardly through the outlet 122. The prosthetic valve 1000 can then be coupled to a valve retaining member 1110 of the delivery apparatus 1100, as described in more detail with respect to FIG. 37, or can be loaded directly into a sheath of the delivery apparatus, as described above with respect to the compression device 100. In certain instances, the actuator 404 does not directly contact the housing 108 during the compression process.

[0077] 23-25 ​​illustrate another example compression device 500. The compression device 500 may generally include a housing 502 having a main body 503 (also referred to as a valve compression portion) and an extender portion 504 (also referred to as a driver or actuator coupling portion), an actuator 506, and a pusher member 508 removably coupled to the actuator. The pusher member 508 may be the same as the pusher member 112 described above (e.g., including a stem 510 having a first end portion 511 and a second end portion 513, and a plurality of arms 512, each having a seat 514), except that the pusher member 508, as compared to the pusher member 112, has an elongated stem 510.

[0078] 25, the actuator 506 (shown coupled to a pusher member 508) can include a base 516 and an extension / extension member 518 extending from the base 516. The base 516 can include a gripping interface 520 for a user to grip. The gripping interface 520 can include, for example, a plurality of circumferentially spaced ridges 522. As shown, the base 516 can also include an opening or aperture 524 into which the second end portion 513 of the pusher member 508 can extend. The aperture 524 can be surrounded by a surface / shoulder / shelf 526 that can engage a resilient locking feature 528 (similar to that described above with respect to the resilient locking feature 174) to releasably couple the pusher member to the actuator 506. The extension 518 can be configured as a cylindrical extension defining an inner bore 519 (FIG. 76) into which the pusher member 508 can extend. The outer surface of the extension member 518 can include a threaded portion 530 configured to engage with a corresponding threaded portion 532 ( FIG. 24 ) disposed on the inner surface of the extender portion 504 of the housing 502 .

[0079] 24, the main body 503 of the housing 502 may be similar to the housing 108 described above (e.g., including an inner funnel segment 505 (FIG. 76) and a plurality of ribs), except that the main body 503 includes an extender portion 504 extending from an inlet end 536 (FIG. 23) of the main body 503 or is coupled to such an extender portion 504. The extender portion 504 may be a substantially cylindrical member including an inner bore 538. In the illustrated example, the extender portion 504 has a diameter greater than the diameter of the main body 503. However, in other examples, such as those shown in the examples of FIGS. 74-76, the diameter of the extender portion 504 may be substantially equal to the diameter of the main body 503. In the example shown in FIG. 23, the extender portion 504 may include a tapered portion 540 that tapers from the diameter of the extender portion 504 to the diameter of the main body 503.

[0080] The housing 502 can include a first side 542 and a second side 542 (FIG. 24) that can be coupled / retained via a retaining ring 544 (FIG. 23) configured to surround the sides 542 and releasably hold them together as described above with respect to the retaining ring 140 and the side 114. The inlet end portion 546 of the extender portion 504 can include a gripping interface 548 for gripping and use by a user. The gripping interface 548 can include, for example, a plurality of circumferentially spaced ridges 550.

[0081] As discussed above, the inner surface of the extender portion 504 may include a threaded portion 532 configured to engage with the threaded portion 530 of the actuator. In use, after the prosthetic valve 1000 is inserted into the main body 503 of the housing 502, the pusher member 508 may be aligned with the prosthetic valve 1000, thereby engaging an adjacent end portion of the prosthetic valve 1000. In this aligned state, the pusher member 508 may be inserted through the extender portion 504 and into the housing 502 until the threads 530 of the actuator 506 engage with the threads 532 of the extender portion 504. In this engaged state, the actuator 506 may be rotated, and the threaded portion may translate the rotation into axial movement (e.g., pushing) of the pusher member 508, thereby driving the pusher member 508 axially forward into the main body 503, thereby pushing the prosthetic valve 1000 through the main body 503. As the prosthetic valve 1000 is forced through the funnel segment of the main body, it is radially compressed and forced outward through outlet 509 ( FIG. 76 ). The prosthetic valve 1000 can then be coupled to a valve retaining member 1110 of a delivery apparatus 1100, as described in more detail with respect to FIG. 37 , or can be loaded directly into a sheath of the delivery apparatus, as described above with respect to the compression device 100.

[0082] As discussed above, FIGS. 74-76 illustrate another example of a compression device 500 in which the extender portion 504 (also referred to as the driver or actuator mating portion) of the housing 502 has an outer diameter that is substantially equal to the outer diameter of the main body 503. Referring to FIG. 76, the main body 503 of the housing 502 can be similar to the housing 108 (e.g., includes an inner funnel segment 505 having multiple ribs) except that the main body 503 includes the extender portion 504. In the illustrated example, the extender portion 504 is integrally formed with the main body 503. However, in other examples, the extender portion 504 can be formed separately from the main body and can be permanently or removably coupled to the main body.

[0083] The extender portion 504 can be a substantially cylindrical member that includes an internal bore 538. In the example shown in FIGS. 74-76, the extender portion 504 has an outer diameter that is substantially equal to the outer diameter of the main body 503. The inner surface of the extender portion 504 can include a threaded portion 532 configured to engage with a corresponding threaded portion 530 on the outer surface of the actuator 506.

[0084] In some examples, as shown in Figures 74-76, the exterior surface of the main body 503 can include a plurality of circumferentially extending ridges 507. The ridges 507 can facilitate gripping by a user. In certain examples, the housing 502, or a portion or portions thereof, can be transparent to facilitate viewing of the prosthetic valve as it is pushed through the funnel.

[0085] 26-29 illustrate another example compression device 600. The compression device 600 may generally include a housing 108 (similar to that described above), an actuator 602, and a pusher member 112 (similar to that described above) that is removably coupled to the actuator 602.

[0086] 27, the actuator 602 can include a threaded guide member configured as a base member 604 including a central opening 606, a plurality of extension members 608 extending from and positioned around a periphery of the base member, and an actuator member configured as an elongated threaded member, hereinafter referred to as a thumb screw 610. In the illustrated example, the actuator 602 includes three extension members 608 spaced equally apart around the periphery. However, in other examples, the actuator 602 can include more or fewer extension members, which can be spaced apart in any configuration.

[0087] Each extension member 608 may be an elongate member and have a first end portion 612 and a second end portion 614 coupled to the base member. The first end portion 612 may include means for coupling the actuator 602 to the housing 108, as shown in FIG. 26. For example, in the illustrated example, the first end portion 612 may include an opening 616 through which a fastener 618 may extend to couple the actuator 602 to the housing 108. As shown in FIG. 26, the extension member 608 may be disposed adjacent to the exterior surface 144 of the housing 108, and the fastener 618 may extend through the extension member 608 to contact or engage a surface of the housing 108 to restrain the actuator 602 from moving relative to the housing 108. In some examples, the opening 616 and the fastener 618 may be threaded such that the fastener may be advanced and / or retracted relative to the extension member 608 by rotationally driving the fastener. Each fastening member 618 can further include a gripping portion or handle 620 (e.g., a loop) configured to allow a user to actuate the fastening member 618. In some examples, the exterior surface 144 of the housing 108 can include an opening or recess into which the fastening member 618 can extend to more securely secure the housing 108 and the actuator 602 to one another. In other examples, for example, each extension member 608 can include an integral protrusion or hook-like end configured to engage a corresponding opening or recess in the housing 108. In such examples, the extension member 608 can be resiliently flexible such that a user can bend the extension member 608 to remove the protrusion from the opening / recess in the housing, thereby disconnecting the actuator 602 from the housing 108.

[0088] As described above, the base member 604 of the actuator 602 can include a central aperture 606 ( FIG. 27 ) extending through a thickness of the base member 604. The aperture 606 can include a threaded portion (e.g., an inner surface) configured to engage a corresponding threaded portion 622 of the thumbscrew 610. The thumbscrew 610 can be an elongate member and has a first end portion 624, a second end portion 626, and an outer surface that includes the threaded portion 622. The second end portion 626 can include a gripping interface 628 for ease of gripping and use (e.g., rotational actuation) by a user. The gripping interface 628 can include, for example, a plurality of circumferentially spaced ridges 630.

[0089] 28, the thumbscrew 610 can have an inner bore 632 extending axially along the length of the thumbscrew 610 such that when the compression device 600 is disposed on the delivery apparatus 102, a portion of the delivery apparatus (e.g., the inner shaft 104 of the delivery apparatus 102) can extend through the inner bore 632. The first end portion 624 of the thumbscrew can include a recess 634 into which the second end portion 164 of the pusher member 112 can extend. The recess 634 can include a first annular shoulder 636 against which the distal edge 113 ( FIG. 7 ) of the pusher member 112 can abut, and a second annular shoulder 638 configured to engage a resilient locking feature 174 on the pusher member 112 to retain the second end portion of the pusher member within the recess 634. The protrusion or lip 176 of the resilient locking feature 174 may engage against the second annular shoulder 638 such that they prevent or reduce axial movement of the pusher member 112 relative to the thumbscrew 610 while still allowing rotational movement of the thumbscrew 610 relative to the pusher member 112. With this configuration, when the thumbscrew 610 is rotationally driven (aided by the engagement of the arms 160 of the pusher member with the ribs 128 of the housing 108), the pusher member 112 may maintain the same rotational orientation while the thumbscrew 610 can drive the pusher member 112 axially forward into the housing 108.

[0090] In use, the compression device 600 can be used to compress a prosthetic valve (e.g., the prosthetic valve 1000 shown in FIG. 36 ) in the following exemplary manner: The prosthetic valve 1000 can be inserted into the housing 108. As shown in FIG. 26 , the extension member 608 of the actuator 602 can be positioned adjacent to the outer surface 144 of the housing 108, and the fastener member 618 can be actuated to couple the actuator 602 to the housing 108. In this coupled state, the pusher member 112 can be aligned with the prosthetic valve 1000, thereby engaging an adjacent end portion of the prosthetic valve 1000. A user can rotate the thumbscrew 610, and the threads of the thumbscrew and the threads of the base member 604 can translate the rotation into axial movement (e.g., pushing) of the thumbscrew 610, which in turn translates into axial movement (e.g., pushing) of the pusher member 112, which can drive the pusher member 112 forward axially into the housing 108. Driving the pusher member 112 forward into the housing 108 forces the prosthetic valve 1000 through the funnel segment 124 of the housing 108, which radially compresses the prosthetic valve and pushes it outward through the outlet 122 for coupling to a delivery apparatus. The prosthetic valve 1000 can then be coupled to a valve retaining member 1110 of a delivery apparatus 1100, as described in more detail with respect to FIG. 37, or can be loaded directly into a sheath of the delivery apparatus, as described above with respect to the compression device 100.

[0091] 30A-30B illustrate another example compression device 700. Compression device 700 can be similar to device 600 described above (e.g., including housing 108 and actuator 702 having thumb screw 704) except where specifically noted.

[0092] The actuator 702 can include a base member 703 (e.g., a guide member) having a threaded opening 705 and one or more extension members 706 extending from the base member 703. The extension members can have a first end portion 708 and a second end portion 712. In certain examples, the extension members 706 can engage or couple to the inner surface 130 of the housing. For example, each of the extension members 706 can include a protrusion 710 configured to extend into a corresponding opening in the inner surface 130 of the housing 108. In other examples, the extension members 706 can be biased radially outward to form a frictional engagement with the inner surface 130 of the housing 108, thereby coupling the actuator 702 to the housing 108. In yet other examples, the members 706 can engage an outer surface of the housing 108 to couple the housing to the actuator 702, such as that shown in FIG. 30B.

[0093] In some examples, the compression device 700 can include a pusher member 714, e.g., a plate member, configured to abut and push against an adjacent portion of the prosthetic valve to drive the prosthetic valve forward through the housing 108. In some examples, the pusher member 714 can be a pusher member such as the pusher member 112 described above. The first end portion 716 of the thumbscrew 704 can include an engagement member 718 (e.g., a pin member) configured to extend through a central opening of the pusher member 714 to couple the pusher member 714 and the thumbscrew 704 to one another. The engagement member 718 can be coupled to the pusher member 714 such that rotational actuation of the thumbscrew 704 does not cause a corresponding rotational movement of the pusher member 714.

[0094] The thumbscrew 704 can include a threaded portion 720 configured to engage a corresponding threaded opening 705 such that rotational driving of the thumbscrew causes axial forward driving of the pusher member 714 relative to the base member 703. The compression device 700 can be used to compress an artificial valve in a manner similar to that described above with respect to the compression device 600.

[0095] 31-33 illustrate another example compression device 800. The compression device 800 can include a housing 108 (similar to that described above), a pusher member 112 (similar to that described above), and an actuator 802.

[0096] The actuator 802 may be a plunger-type actuator (e.g., a caulking gun or other similar device) and has a holder / frame / barrel portion 804 coupled to a handle 806. The barrel portion 804 may have a first end portion 808 and a second end portion 810 coupled to the handle 806. The first end portion 808 may include a retaining member 812 configured to releasably couple to the housing 108.

[0097] In the illustrated example, the retaining member 812 can have an annular shape corresponding to the periphery of the housing 108. However, in other examples, the retaining member 812 can have any shape configured to correspond to the outer periphery of the housing. In some examples, the housing and the retaining member can include corresponding engagement features that allow the two components to be removably coupled to one another. For example, the housing 108 can include one or more protrusions 814 configured to extend into recesses or into openings in the retaining member 812, and / or the retaining member 812 can include protrusions configured to extend into recesses or into openings in the housing 108. In other examples, the housing 108 can be retained by the retaining member using a frictional engagement. In some examples, the retaining member 812 can be used instead of or in addition to the retaining ring 140. The retaining member 812 can further include an opening or outlet 811 configured to align with the outlet 122 of the housing 108. As shown in FIG. 31 , the outlet 811 can have a larger diameter than the outlet 122 of the housing 108, for example, such that the sheath 106 of the delivery device 102 can abut directly against the outlet end portion of the housing and surround the outlet 122.

[0098] The handle 806 can include an actuator member 816 configured as a plunger and a trigger member 818. For example, in some examples, the handle 806 can be similar to a handle on a caulking gun. The trigger 818 can be configured to drive the actuator member 816 forward when actuated (e.g., when pulled) by a user. For example, each time the trigger is pulled, the actuator member 816 can be incrementally driven forward in a first direction (e.g., toward the housing 108) and can be constrained from moving in an opposite second direction (e.g., away from the housing 108). In some examples, the trigger can advance and / or retract the actuator member. For example, when the trigger is depressed, a user can retract the actuator member by pulling the actuator member away from the housing. In certain examples, the actuator member 816 can be permanently or removably coupled to an extender 820 configured to removably couple to the pusher member 112.

[0099] 32, the extender 820 can include a base portion 822, a central extension member 824, a pusher member holder 826, and an inner bore 828 extending along the length of the extender 820. The base portion 822 can be coupled to the actuator member 816 as shown in FIG. 31. The pusher member holder 826 can include an inner recess 830 into which the second end portion 164 of the pusher member 112 can extend. The recess 830 can include a first annular shoulder 832 against which the distal edge 113 (FIG. 7) of the pusher member 112 can abut, and a second annular shoulder 834 configured to engage a resilient locking feature 174 on the pusher member 112 to retain the second end portion of the pusher member within the recess 830. A protrusion or lip 176 of the resilient locking feature 174 can engage the second annular shoulder 834. The pusher member 112 can rotate within the extender 820, which allows a user to manually align the arm 160 of the pusher member 112 with respect to the prosthetic valve and engage it against an adjacent end portion of the prosthetic valve. When the actuator member 816 is driven forward using the trigger 818, the actuator member 816 drives the extender 820 (and thus the pusher member 112) forward relative to the housing 108.

[0100] In use, the compression device 800 can be used to compress a prosthetic valve (e.g., the prosthetic valve 1000 shown in FIG. 36 ) in the following exemplary manner: The prosthetic valve 1000 can be inserted into the housing 108, which can be inserted into the retaining member 812 of the actuator. A user can actuate the trigger 818 to drive the actuator member 816 (and thus the extender 820 and the pusher member 112) forward until the pusher member 112 engages against an adjacent end portion of the prosthetic valve 1000. The user can continue to actuate the trigger 818 to drive the pusher member forward through the housing 108, thereby driving the prosthetic valve forward. As the prosthetic valve 1000 is pushed through the funnel segment 124 of the housing, it is radially compressed and pushed outwardly through the outlet 122. The prosthetic valve 1000 can then be coupled to the valve retaining member 1110 of the delivery apparatus 1100, as described in more detail with respect to FIG 37, or can be loaded directly into the sheath of the delivery apparatus, as described above with respect to the compression device 100. In certain examples, the extender member 820, or a portion thereof (e.g., the pusher member holder 826), can be an integral part of the plunger member 816, such as an end portion of the plunger member 816.

[0101] 34-35 illustrate another example compression device 900. The compression device 900 can include a housing 108 (as described above), a pushing member 112 (as described above), and an actuator 902. The actuator 902 can be configured as a hydraulic actuator configured to use pressurized hydraulic fluid to drive the pushing member 112 forward into the housing 108. In a particular example, the hydraulic fluid can be pumped into the actuator 902, such as by using a syringe.

[0102] The actuator 902 can include a fluid chamber 904 and a piston 906. The piston 906 can have a first end portion 908 (e.g., on a shaft member of the piston) with one or more openings 910 configured to engage with a resilient locking feature 174 of the pusher member 112 to releasably couple the pusher member and the piston to one another. A second end portion 912 of the piston 906 can be configured as a disk-shaped piston head 914 having an outer periphery corresponding to the shape of the fluid chamber 904. The piston head 914 can be sized to move within the fluid chamber 904 and to form a seal against the chamber wall such that fluid cannot leak through the periphery of the piston head 914. In other words, the outer diameter of the piston head 914 can be substantially equal to the inner diameter of the fluid chamber 904. In some examples, the piston head 914 can further include one or more O-rings or other sealing members 915 disposed around the outer periphery of the piston head 914, which can help seal the piston head to prevent fluid from leaking past the periphery of the piston head.

[0103] The fluid chamber 904 can include a first end portion 916 and a second end portion 918. In the illustrated example, the chamber 904 is cylindrical, although in other examples, the fluid chamber can have any of a variety of shapes. The first end portion 916 can include an opening or aperture 920 configured to allow the first end portion 908 of the piston 906 to extend therethrough, as shown in FIGS. 34-35. The second end portion 918 can include an inlet 922 configured to fluidly couple (e.g., using flexible tubing) to a fluid dispensing device, fluid reservoir, or pump, such as, for example, a syringe, such as a high pressure syringe (see, for example, syringe 2208 shown in FIG. 51). In a particular example, the syringe can be an Atrion QL® syringe.

[0104] The fluid chamber 904 can further include a plurality of extension members 924 extending from and disposed around a periphery of the first end portion 916. In the illustrated example, the actuator 902 includes three extension members 924 spaced equally apart around the periphery. However, in other examples, the actuator 902 can include more or fewer extension members, which can be spaced apart in any configuration.

[0105] Each extension member 924 may be an elongate member and may have a first end portion 926 and a second end portion 928 coupled to the fluid chamber 904. The first end portion 926 may include means for coupling the actuator 902 to the housing 108. For example, in the illustrated example, the first end portion 926 may include an opening through which a fastener 930 may extend to couple the first end portion 926 to the housing 108. As shown in FIG. 34 , the extension member 924 may be positioned adjacent to the exterior surface 144 of the housing 108, and the fastener 930 may extend through the extension member 924 into a corresponding recess or opening in the housing 108 to restrain the actuator from moving relative to the housing. In other examples, the fastener may extend through the extension member to frictionally contact or engage the exterior surface of the housing 108. Each fastening member 930 may further include a gripping portion or handle 932 (e.g., a loop) configured to allow a user to drive / rotate the fastening member 930. In other examples, for example, each extension member 924 may include an integral protrusion or hook-like end configured to engage a corresponding opening or recess in the housing 108. In such examples, the extension member 924 may be resiliently flexible such that a user may bend the extension member 924 to remove the protrusion from the opening / recess in the housing 108, thereby disconnecting the actuator 902 from the housing 108. In some examples, the opening in the extension member 924 and the fastening member 930 may be threaded such that the fastening member 930 may be advanced and / or retracted relative to the extension member 924 by rotationally driving the fastening member.

[0106] In use, the compression device 900 can be used to compress a prosthetic valve (e.g., the prosthetic valve 1000 shown in FIG. 36 ) in the following exemplary manner: The prosthetic valve 1000 can be inserted into the housing 108. The extension member 924 of the actuator 902 can be positioned adjacent to the exterior surface 144 of the housing 108, and the fastener member 930 can be actuated (e.g., using the handle 932) to couple the actuator 902 to the housing. In this coupled state, the pusher member 112 can be aligned with the prosthetic valve 1000, thereby engaging an adjacent end portion of the prosthetic valve 1000. A user can actuate the fluid reservoir (e.g., by depressing a plunger of a syringe or by activating a pump) to dispense a fluid (e.g., saline) into the fluid chamber 904 via the inlet 922. As the fluid chamber 904 fills with fluid, the pressure drives the piston 906 forward, which drives the pusher member 112 axially forward into the housing 108. Driving the pusher member forward into the housing forces the prosthetic valve 1000 through the funnel segment 124 of the housing 108, which radially compresses the prosthetic valve and forces it outward through the outlet 122. The prosthetic valve 1000 can then be coupled to the valve retaining member 1110 of the delivery apparatus 1100, as described in more detail with respect to FIG. 37, or can be loaded directly into the sheath of the delivery apparatus, as described above with respect to the compression device 100. In certain examples, the working fluid can be a liquid, such as an aqueous liquid (e.g., saline), or can be a gas (e.g., a compressed inert gas such as nitrogen, carbon dioxide, etc.).

[0107] In some examples, all of the components in the compression devices disclosed herein (e.g., compression devices 100, 200, 300, 400, 500, 600, 700, 800, 900, etc.) can be disposable. In other examples, one or more components in any compression device described herein can be configured to be reusable. For example, the actuators of each compression device (e.g., hydraulic actuator 902, and plunger-type actuator 802) can be configured to be reusable multiple times for multiple prosthetic valves.

[0108] Any or all of the compression device assembly components described herein can be formed from polymeric materials, such as injection molded plastic. In certain examples, one or more components can also be formed by three-dimensional printing or by other additive manufacturing processes. In certain examples, components that are subject to high stress, high friction, or the like, or portions of such components can include other materials, such as metals, ceramics, etc., depending on the particular properties desired.

[0109] 36 is a side view of an exemplary prosthetic valve 1000 as may be compressed using any of the compression devices disclosed herein. The prosthetic valve 1000 includes a radially expandable and compressible metal frame 1002 that supports a plurality of leaflets 1004 therein. In some examples, the frame 1002 may include an inner frame portion and an outer frame portion. The prosthetic valve 1000 may also include a seal member 1006 (e.g., a fabric skirt) secured on the outside of the frame 1002 and configured to form a seal against the native annulus. In certain examples, the prosthetic valve 1000 is self-expandable with the frame 1002 formed from a self-expanding metal (e.g., Nitinol). In other examples, as described above, the prosthetic valve 1000 may be balloon expandable or mechanically expandable.

[0110] The frame 1002 can include a main body 1003 and a first set of anchors 1008 and a second set of anchors 1010 extending from opposite portions of the main body 1003. In some specific examples, the prosthetic valve 1000 is a prosthetic mitral valve, and the first anchor 1008 is part of the atrial portion of the valve and configured to help anchor the prosthetic valve 1000 to the left atrium, while the second anchor 1010 is part of the ventricular portion of the valve and configured to help anchor the prosthetic valve 1000 to the left ventricle. The second anchor 1010 can be disposed between a plurality of apexes 1013 of the frame 1002. An end of the frame 1002 opposite the second anchor 1010 can include a plurality of connecting arms 1012 with an enlarged end portion 1014. The end portion 1014 is configured to engage an engagement feature of a delivery device to form a detachable connection between the prosthetic valve and a delivery device. Further details regarding prosthetic valves can be found, for example, in US Pat. No. 10,639,143, which is incorporated herein by reference in its entirety.

[0111] As noted above, the plurality of ribs 128 within the housing of any of the disclosed compression devices can aid in aligning the prosthetic valve 1000. For example, the prosthetic valve 1000 can be aligned within a respective compression device with one or both of the first set of anchors 1008 and the second set of anchors 1010 disposed between the plurality of ribs 128, ensuring that the enlarged end portion 1014 is aligned for engagement with an engagement feature of the delivery device to form a releasable connection between the prosthetic valve and the delivery device. As the prosthetic valve is pushed out of the outlet 122, the second set of anchors 1010 can be radially compressed against the main body 1003 of the frame 1002 of the prosthetic valve 1000. In an alternative example, the second tapered portion 134 (FIG. 2) of the funnel segment 124 can be shaped such that as the prosthetic valve 1000 moves through the funnel segment 124, the anchor 1010 is bent away from the main body 1003 and into a substantially straight configuration extending 180 degrees from the main body 1003.

[0112] 37 shows a distal end portion of an exemplary delivery apparatus 1100 that may be used to deliver and implant the prosthetic valve 1000 into a patient's body. Any compression device disclosed herein may be used to at least partially compress the prosthetic valve 1000 and couple the prosthetic valve 1000 to the valve retaining member 1110. After coupling the prosthetic valve 1000 to the valve retaining member 1110, the prosthetic valve 1000 may be further compressed and loaded into the delivery apparatus using a separate loading assembly 2400 (FIG. 53).

[0113] 37, the delivery device 1100 generally includes an outer sheath 1102, a first shaft 1104 extending coaxially through the sheath 1102, and a second shaft 1106 extending coaxially through the first shaft 1104. A nose cone 1108 can be attached to a distal end portion of the second shaft 1106. Although not shown, the proximal end portions of the sheath 1102, the first shaft 1104, and the second shaft 1106 can be coupled to a handle, and each of these components can be axially movable relative to one another.

[0114] The valve retaining member 1110 may be connected to a distal end portion of the first shaft 1104 and may include a plurality of circumferentially spaced slots 1112 sized to receive the connecting arms 1012 of the prosthetic valve 1000. During the compression process, the valve retaining member 1110 may be initially located outside the sheath 1102. When the prosthetic valve 1000 is initially pushed out of the outlet 122 of the housing 108, the connecting arms 1012 may be located within each of the slots 1112 of the valve retaining member 1110. The enlarged end portion 1014 may be positioned within the annular slots 1114 at a location proximal to the slots 1112 to prevent axial separation of the prosthetic valve from the valve retaining member. Further details regarding loading and engagement of the prosthetic valve to the delivery device may be found, for example, in U.S. Patent Publication No. 2018 / 0055629.

[0115] In some examples, after the prosthetic valve is coupled to the valve retaining member 1110, the compression device can be removed from the delivery apparatus, and a separate compression loading assembly (such as loading assembly 2400) can be used to compress the prosthetic valve 1110 into a delivery configuration and load the prosthetic valve into the sheath 1102. In other examples, the sheath 1102 can be driven distally past the valve retaining member 1110 and the prosthetic valve 1000 as the prosthetic valve is driven further forward from the compression device. After the delivery apparatus 1100 is inserted into the patient's vasculature and the distal end portion is positioned at or adjacent to the desired implantation site (e.g., the native mitral valve), the sheath 1102 can be retracted proximally to deploy the prosthetic valve 1000 from the sheath 1102, allowing the prosthetic valve to expand based on its own elasticity. When the sheath 1102 is retracted proximally beyond the valve retaining member 1110, the connecting arms 1012 can be expanded radially away from engagement with the slots 1112, thereby allowing the prosthetic valve to be disconnected from the delivery device.

[0116] 38 illustrates another example compression device 1200, including a housing 1202 and an actuator 1204. The housing 1202 can be similar to the housing 108 described above, except as specifically noted. The actuator 1204 can include a base member / base plate 1206 and a movable portion 1208. The movable portion 1208 can be removably coupled to a pusher member 1210, such as or similar to the pusher member 112 described above, for holding the prosthetic valve (e.g., the prosthetic valve 1000) and for driving the prosthetic valve forward through a funnel segment 1212 of the housing 1202. The pusher member 1210 can be coupled to the movable portion 1208 of the actuator.

[0117] The base member 1206 can include one or more extension members 1214 (e.g., elongate members) configured to removably couple the actuator 1204 to the housing 1202. For example, in some examples, the extension members 1214 can be similar to the extension members 608 or 924 described above. In other examples, the extension members 1214 can engage with an inner surface of the housing 1202 (e.g., via frictional engagement and / or via engagement features (e.g., fasteners, etc.) configured to mate with corresponding engagement features and / or openings on the housing).

[0118] The movable portion 1208 may include a rack and pinion assembly 1216 including a linear rack member 1218 having a plurality of teeth 1220 and a circular gear or pinion member 1222 having a corresponding plurality of teeth 1224 configured to engage with the teeth 1220 of the linear rack 1218. The two sets of teeth 1220, 1224 may be configured to engage with one another such that rotationally driving the pinion 1222 in a first direction correspondingly drives the linear rack 1218 axially in a first direction (e.g., represented by arrow 1226) and rotationally driving the pinion in a second direction correspondingly drives the linear rack 1218 axially in a second direction opposite the first direction. In some examples, the teeth 1220 of the linear rack 1218 can be angled such that the rack can move axially relative to the pinion 1222 in a first orientation, but is prevented from moving relative to the pinion in a second orientation. In other words, in some examples, the rack and pinion assembly 1216 can include or function as a ratchet mechanism.

[0119] The pinion 1222 can be coupled to an actuator member 1228 (e.g., a knob or lever) configured to rotationally drive the pinion 1222. In some examples, the pinion 1222 can be a bevel gear and the actuator can include a corresponding head portion configured to engage the bevel gear. Rotationally driving the actuator member 1228 in a first direction (e.g., as represented by arrow 1230) can correspondingly rotate the pinion 1222 in a first direction, which can drive the linear rack 1218 and the pusher member 1210 forward relative to the housing 1202. Rotationally driving the actuator member 1228 in a second direction (e.g., opposite the first direction) can correspondingly rotate the pinion 1222 in a second direction, which can drive the linear rack 1218 backward relative to the housing 1202.

[0120] In use, the compression device 1200 can be used to compress a prosthetic valve (e.g., the prosthetic valve 1000 shown in FIG. 36 ) in the following exemplary manner: The prosthetic valve 1000 can be inserted into the funnel segment 1212 of the housing 1202. The actuator 1204 can be coupled to the housing 1202 using the extension member 1214. So coupled, the pusher member 1210 can be aligned with the prosthetic valve 1000 and thereby engaged against an adjacent end portion of the prosthetic valve 1000. A user can actuate the actuator member 1228 (e.g., by rotating a knob) to rotationally drive the pinion 1222, causing corresponding axial movement of the linear rack 1218, which drives the pusher member 1210 axially forward into the housing 1202. By driving the pusher member 1210 forward into the housing, the prosthetic valve 1000 is forced through the funnel segment 1212 of the housing 1202, which radially compresses the prosthetic valve and forces it outwardly through the outlet 1232. The prosthetic valve 1000 can then be coupled to the valve retaining member 1110 of the delivery apparatus 1100, as described in more detail with respect to FIG. 37, or can be loaded directly into the sheath of the delivery apparatus, as described above with respect to the compression device 100.

[0121] 39 illustrates another example compression device 1300, including a housing 1302 and an actuator 1304. The housing 1302 can be similar to the housing 108 described above, except as specifically noted. The actuator 1304 can include a base member or plate 1306 and a movable portion 1308. The movable portion 1308 can be removably coupled to a pusher member 1310, such as or similar to the pusher member 112 described above, for holding the prosthetic valve (e.g., the prosthetic valve 1000) and for driving the prosthetic valve forward through a funnel segment 1312 of the housing 1302 to an outlet 1314.

[0122] The base member 1306 can include one or more extension members 1316 (e.g., elongate members) configured to removably couple the actuator 1304 to the housing 1302. For example, in some examples, the extension members 1316 can be similar to the extension members 608 or 924 described above. In other examples, the extension members 1316 can engage with an inner surface of the housing 1302 (e.g., via frictional engagement and / or via an engagement member configured to couple with a corresponding engagement member and / or aperture on the housing). The movable portion 1308 can include a lever 1318 and a cam member 1320. The cam member 1320 can be pivotally coupled to the base member 1306 and rigidly attached to the lever 1318, for example, at a pin 1322, such that rotationally driving the lever 1318 (represented by arrow 1324) correspondingly drives the cam member 1320 (represented by arrow 1326). In other examples, the lever 1318 can be a knob or other type of drive mechanism configured to cause rotational movement of the cam member 1320 .

[0123] The cam member 1320 can be configured such that rotationally driving the cam member 1320 applies a driving force to the pusher member 1310 in a first direction, thereby driving the pusher member axially forward into the housing 1302. For example, the cam member 1320 can have a lobed shape configured to contact and apply a driving force to the pusher member 1310 when the lever 1318 is actuated. In some particular examples, less than 1 inch (25.40 mm) of movement is required to drive the pusher member 1310 fully forward into the housing 1302 (e.g., advance the prosthetic valve at least partially through the outlet). In such examples, only a single rotation of the lever 1318 (e.g., a single movement between about 90 degrees and about 180 degrees) may be required to advance the prosthetic valve at least partially through the outlet. In other examples, the lever 1318 can be actuated multiple times to drive the prosthetic valve forward into / through the outlet. In such an example, the compression device 1300 may further include a locking or ratcheting mechanism configured to prevent the pusher member 1310 from sliding rearwardly out of the housing 1302 between actuations of the lever 1318.

[0124] In use, the compression device 1300 can be used to compress a prosthetic valve (e.g., the prosthetic valve 1000 shown in FIG. 36 ) in the following exemplary manner: The prosthetic valve 1000 can be inserted into the funnel segment 1312 of the housing 1302. The actuator 1304 can be coupled to the housing 1302 using an extension member 1316. When so coupled, the pusher member 1310 can be aligned with the prosthetic valve 1000 such that it engages an adjacent end portion of the prosthetic valve 1000. A user can actuate lever 1318 (e.g., by rotationally driving lever 1318 between about 90 degrees and about 180 degrees) to rotate cam member 1320, which can contact pusher member 1310 and cause corresponding axial movement of pusher member 1310, driving pusher member 1310 axially forward into housing 1302. Driving pusher member 1310 forward into housing 1302 forces prosthetic valve 1000 through funnel segment 1312 of housing 1302, which radially compresses the prosthetic valve and pushes it outward through outlet 1314. The prosthetic valve 1000 can then be coupled to the valve retaining member 1110 of the delivery apparatus 1100, as described in further detail with respect to FIG. 37, or can be loaded directly into the sheath of the delivery apparatus, as described above with respect to the compression device 100.

[0125] 40 illustrates another example compression device 1400 including a housing 1402 and an actuator 1404. The housing 1402 can be similar to the housing 108 described above, except as specifically noted. The actuator 1404 can include a base member / base plate 1406 and a movable portion 1408. The movable portion 1408 can be removably coupled to a pusher member 1410, such as or similar to the pusher member 112 described above, for holding the prosthetic valve (e.g., the prosthetic valve 1000) and for driving the prosthetic valve forward through a funnel segment 1412 of the housing 1402 and out an outlet 1414.

[0126] The base member 1406 can include one or more extension members 1416 (e.g., elongate members) configured to removably couple the actuator 1404 to the housing 1402. For example, in some examples, the extension members 1416 can be similar to the extension members 608 or 924 described above. In other examples, the extension members 1416 can engage with an inner surface of the housing (e.g., via frictional engagement and / or via engagement members configured to mate with corresponding engagement members and / or openings on the housing).

[0127] The movable portion 1408 can include a ratchet mechanism or assembly 1418 including a linear rack member 1420 having a plurality of teeth 1422 and a pawl member 1424 configured to engage the teeth 1422 of the linear rack 1420. The pawl 1424 and teeth 1422 are configured such that when the pawl 1424 engages the rack 1420, the linear rack 1420 (and thus the pusher member 1410) can move relative to the base member 1406 in a first axial direction (e.g., as represented by arrow 1426) but is prevented from moving relative to the base member 1406 in an opposite second axial direction. This configuration allows compression / compression of the artificial valve while preventing elastic expansion of the artificial valve from pushing the pusher member 1410 out of the housing 1402.

[0128] The pawl 1424 can be coupled to the actuator member 1428 via a pivot or rotatable pin 1430. The pin 1430 can be spring biased to keep the pawl 1424 engaged with the teeth 1422 of the linear rack 1420. The actuator member 1428 can be pivotally coupled to the respective extension member 1416 and / or base member 1406, e.g., via a pin 1432, such that a user can actuate the actuator member 1428 to cause movement of the linear rack 1420 relative to the base member 1406 (e.g., drive the pusher member 1410 forward into the housing 1402). The actuator 1404 can further include a locking member 1434 (e.g., an additional pawl) configured to further prevent movement of the linear rack 1420 in a second axial direction (e.g., away from the housing 1402). The locking member 1434 may be pivotally coupled to the base member 1406 via a pin 1436. Although the actuator member 1428 is shown as a lever in the illustrated example, in other examples, the actuator member 1428 may be, for example, a knob or other mechanism configured to drive the pawl 1424 against the linear rack 1420 when actuated.

[0129] In use, the compression device 1400 can be used to compress a prosthetic valve (e.g., the prosthetic valve 1000 shown in FIG. 36 ) in the following exemplary manner: The prosthetic valve 1000 can be inserted into the funnel segment 1412 of the housing 1402. The actuator 1404 can be coupled to the housing 1402 using an extension member 1416. When so coupled, the pusher member 1410 can be aligned with the prosthetic valve 1000 and engaged against an adjacent end portion of the prosthetic valve 1000. A user can actuate the actuator member 1428 (e.g., by pivoting a lever) to actuate the pawl 1424 to axially move the linear rack 1420 in a first axial orientation, which drives the pusher member 1410 axially forward into the housing 1402. By driving the pusher member 1410 forward into the housing 1402, the prosthetic valve 1000 is forced through a funnel segment 1412 of the housing 1402, which radially compresses the prosthetic valve and forces it outwardly through the outlet 1414. The prosthetic valve 1000 can then be coupled to a valve retaining member 1110 of a delivery apparatus 1100, as described in more detail with respect to FIG. 37, or can be loaded directly into a sheath of the delivery apparatus, as described above with respect to the compression device 100.

[0130] 41 illustrates another example compression device 1500 that includes a housing 1502 and an actuator 1504. The housing 1502 can be similar to the housing 108 described above, except where specifically noted. The housing 1502 can have a gripping portion or handle 1506 coupled thereto such that a user can hold the housing 1502 via the handle 1506. The handle 1506 can be permanently or removably coupled to the housing.

[0131] The actuator 1504 can include an extension member 1508 coupled to the housing 1502. The extension member 1508 can be pivotally coupled to a movable portion configured as a lever member 1510. As shown in FIG. 41, the lever 1510 can include a pusher member or protrusion 1512 configured to drive the prosthetic valve forward into the housing 1502. In the illustrated example, the protrusion 1512 acts against a pusher member configured as a flat or plate member 1514 disposed at an inlet end portion 1516 of the housing 1502. In some examples, the plate member 1514 can include a number of recesses or openings configured to engage ribs (such as, for example, the ribs 128 described above) within the housing 1502 such that the plate member 1514 can be inserted into the housing and driven forward within the housing to compress the prosthetic valve. In other examples, the plate member 1514 can be coupled to a pusher member such as the pusher member 112 described above. In yet other examples, instead of the plate 1514, the pusher member 112 can be removably coupled to the protrusion 1512 or can be disposed within the inlet end portion 1516. In some examples, the handle 1506 and the lever 1510 can include corresponding locking features configured to removably lock the handle 1506 and the lever 1510 together when the lever 1510 is actuated, thereby locking the compression device 1500 with the prosthetic valve 1000 in the compressed position.

[0132] In use, the compression device 1500 can be used to compress a prosthetic valve (e.g., the prosthetic valve 1000 shown in FIG. 36 ) in the following exemplary manner: The prosthetic valve 1000 can be inserted into the funnel segment 1518 of the housing 1502, and the plate 1514 and / or the pusher member 112 can be aligned with and engaged against an adjacent end portion of the prosthetic valve 1000. A user can pivot the lever 1510 (e.g., as shown by arrow 1520) to engage the protrusion 1512 against the plate 1514 and drive the plate 1514 (and thus the prosthetic valve 1000) axially forward into the housing 1502. Driving the plate 1514 forward into the housing forces the prosthetic valve 1000 through the funnel segment 1518 of the housing 1502, which radially compresses the prosthetic valve and forces it outwardly through the outlet 1520. The prosthetic valve 1000 can then be coupled to a valve retaining member 1110 of a delivery apparatus 1100, as described in more detail with respect to FIG. 37, or can be loaded directly into a sheath of the delivery apparatus, as described above with respect to the compression device 100.

[0133] In some examples, as shown in FIG. 42, instead of the handle 1506, the compression device 1500 can include an actuator member 1522 coupled to the lever 1510 and configured to allow a user to actuate the lever 1510. The actuator member 1522 can be an elongated threaded member and has a first end portion 1524 coupled to the housing 1502. In the illustrated example, the actuator member 1522 is coupled to an exterior surface of the housing 1502, but in other examples, the actuator member 1522 can be coupled to an interior surface of the housing 1502, for example, at the inlet portion 1516. The first end portion 1524 can be coupled to the housing 1502 via a member configured as a mounting member, protrusion, boss, and / or block 1530 having an opening through which the actuator member 1522 extends. The first end portion 1524 can include a locking member or cap 1532 configured to prevent the actuator member 1522 from being freely pulled out of the block 1530.

[0134] The actuator member 1522 can have a second end portion 1526 that extends through an opening in the lever 1510. An actuator member configured as a threaded wing nut 1528 (also referred to as a fastener) can be disposed on the actuator member 1522 on the second end portion 1526 adjacent to the lever 1510. In some instances, both the opening and the fastener can be threaded, and in other instances, only one of these two components is threaded. In use, after the prosthetic valve and the plate 1514 are positioned within the housing, a user can drive the lever 1510 forward relative to the housing 1502 by actuating the fastener 1528 (e.g., by driving the fastener 1528 rotationally along the threads of the actuator member 1522). Such a configuration advantageously reduces the amount of force a user must apply to compress the prosthetic valve. The threaded engagement between the wing nut 1528 and the actuator member 1522 reduces or prevents movement of the lever 1510 in a second direction (e.g., away from the housing 1502), thereby allowing the user to release the actuator 1504 during the compression process without the artificial valve elastically decompressing and pushing the lever 1510 out of the housing.

[0135] 43A-C illustrate another example compression device 1600 that includes a housing 1602 and an actuator 1604. The housing 1602 can have a hemispherical or cup shape defining an inner funnel segment 1606 and can include an outlet 1608. The actuator 1604 can include a base portion 1610 and a pushing member 1612 for holding a prosthetic valve (e.g., the prosthetic valve 1000) and for driving the prosthetic valve forward through the funnel segment 1606 and out the outlet 1608.

[0136] As shown in FIG. 43B, the pusher member 1612 can include a stem 1613, an annular lip or shoulder 1614, and a dome-shaped central projection 1616. The prosthetic valve 1000 can be placed on the pusher member such that an edge portion (e.g., an inflow edge portion) of the prosthetic valve 1000 seats on the annular lip 1614 and the central projection 1616 seats within the interior of the prosthetic valve 1000. The base portion 1610 of the actuator 1604 can include one or more engagement features 1618 configured to releasably couple to corresponding engagement features 1620 ( FIG. 43A ) on the housing 1602, thereby locking the actuator 1604 and the housing 1602 together after the prosthetic valve 1000 reaches a selected compressed configuration (e.g., partial or full compression). This allows the user to release the actuator 1604 without the resilient spring force of the artificial valve pushing the pusher member 1612 out of the housing 1602 .

[0137] In the illustrated example, the engagement feature 1618 is configured as a resilient latch (e.g., two diametrically opposed resilient latches) that include protrusions or teeth 1622 ( FIG. 43B ) that can engage with corresponding features 1620 (e.g., an opening) in the housing 1602. The engagement feature 1618 can deflect radially inward when the actuator 1604 is driven forward relative to the housing 1602, and can deflect radially outward after being guided within the opening 1620, thereby coupling the actuator 1604 and the housing 1602 together via a snap-fit ​​connection.

[0138] In the illustrated example, the pusher member 1612 and the base portion 1610 are formed as a unitary member, however, in other examples, the pusher member 1612 and the base portion 1610 may be formed as separate members and may be removably or permanently coupled (e.g., as described above with respect to the pusher member 112 and the actuator 110).

[0139] As shown, the housing 1602 can include a ridged inner surface 1624 configured to aid in alignment of the prosthetic valve 1000 with engagement features of a delivery device during compression of the prosthetic valve and driving of the prosthetic valve forward through the funnel segment 1606. The housing 1602 can include an annular lip or shoulder 1626 disposed about an outer periphery of the housing and configured to selectively abut a distal edge 1628 of the base portion 1610 of the actuator 1604 (as shown in FIG. 43C ). The housing 1602 can further include an extension portion 1630 having a diameter smaller than the diameter of the base portion 1610 of the actuator 1604 such that the extension portion 1630 seats within the actuator 1604 when the actuator 1604 and the housing 1602 are coupled together. As described above and as shown in FIG. 43C, the shoulder 1626 can include one or more engagement features 1620 (e.g., apertures / openings) configured to engage with the engagement features 1618 on the actuator 1604.

[0140] In use, the compression device 1600 can be used to compress a prosthetic valve (e.g., the prosthetic valve 1000 shown in FIG. 36 ) in the following exemplary manner: The prosthetic valve 1000 can be inserted into the funnel segment 1606 of the housing 1602. The actuator 1604 can be positioned such that the pusher member 1612 is aligned with an adjacent end portion of the prosthetic valve 1000 (e.g., such that an inflow end portion of the prosthetic valve 1000 is disposed on the annular lip 1614 of the pusher member 1612). A user can actuate the actuator member 1604 (e.g., by manually depressing the actuator) to drive the pusher member 1612 axially forward into the housing 1602. By driving the pusher member 1612 forward into the housing 1602, the prosthetic valve 1000 is forced through the funnel segment 1606 of the housing 1602, which radially compresses the prosthetic valve and forces it outwardly through the outlet 1608. The prosthetic valve 1000 can then be coupled to a valve retaining member 1110 of a delivery apparatus 1100, as described in more detail with respect to FIG. 37, or can be loaded directly into a sheath of the delivery apparatus, as described above with respect to the compression device 100.

[0141] 44-45 illustrate another example compression device 1700 including a housing 1702, an actuator 1704, and a pusher member 1706 (FIG. 45). The pusher member 1706 can be the same as or similar to the pusher member 112 described above for holding a prosthetic valve (e.g., prosthetic valve 1000) and for driving the prosthetic valve 1000 forward through a funnel segment 1708 (FIG. 45) of the housing 1702 to an outlet 1710 (FIG. 45).

[0142] The actuator 1704 can include a base member 1712 and a cylindrical extension member 1714 having an inner diameter larger than an outer diameter of the housing 1702 such that the actuator 1704 can be driven axially forward on the housing 1702. The extension member 1714 can include one or more protrusions / projections / pins 1716 extending radially inward from an inner surface of the extension member 1714 and configured to engage one or more channels / recesses / tracks 1718 disposed in an outer surface 1720 of the housing 1702.

[0143] In some examples, the actuator 1704 can further include a gripping interface 1722 for easy gripping and use by a user (e.g., on the base member 1712). The gripping interface 1722 can include, for example, a number of circumferentially spaced ridges 1724.

[0144] The housing 1702 may be similar to the housing 108 described above, except that the housing 1702 includes one or more channels / recesses / tracks 1718 (e.g., two diametrically opposed channels) disposed within an exterior surface 1720 of the housing 1702. When the actuator 1704 is driven forward on the housing 1702, the pin 1716 may advance within the channel 1718. In some examples, the channel 1718 may extend at least partially through the thickness of the wall of the housing 1702, while in other examples, the channel 1718 may extend completely through the wall to form a slot. The channel 1718 may extend from an entrance or opening 1726 in the housing 1702 along at least a portion of the length of the housing.

[0145] In some examples, such as that shown in FIG. 44, the channel 1718 can include an axially extending first portion 1728 and an angled second portion 1730. In such examples, the pin 1716 of the actuator 1704 can be driven forward within the axially extending portion 1728, and then the actuator 1704 can be twisted or rotated to continue to drive the pin 1716 forward within the angled portion 1730. In other examples, such as that shown in FIG. 45, one or more channels 1718 can include multiple steps, each step having an axially extending portion 1732 and a laterally extending portion 1734. In some examples, the steps can further include a stop or rest portion 1736. In such an example, the pin 1716 can be driven forward within the axially extending portion 1732 until it reaches the laterally extending portion 1734, and then the actuator 1704 and / or the housing 1702 can be twisted / rotated to cause the pin to slide laterally along the laterally extending portion 1734. The lock or rest portion 1736 provides a distinct locking point that allows a user to release the force applied to the actuator 1704 and / or the housing 1702 without the resilient spring force of the prosthetic valve pushing the actuator 1704 out of the housing. The steps allow for incremental compression of the prosthetic valve 1000 as the actuator 1704 is driven forward on the housing 1702.

[0146] In use, the compression device 1700 can be used to compress a prosthetic valve (e.g., the prosthetic valve 1000 shown in FIG. 36 ) in the following exemplary manner: The prosthetic valve 1000 can be inserted into the funnel segment 1708 of the housing 1702. The actuator 1704 can be positioned such that the pusher member 1706 ( FIG. 45 ) is aligned with an adjacent end portion of the prosthetic valve 1000 and such that the pin 1716 is aligned with the channel 1718. A user can then actuate the actuator member 1704 (e.g., by manually pushing the actuator) to drive the pin 1716 forward within the channel 1718, which drives the pusher member 1706 axially forward into the housing 1702. By driving the pusher member 1706 forward into the housing 1702, the prosthetic valve 1000 is forced through a funnel segment 1708 of the housing 1702, which radially compresses the prosthetic valve and forces it outwardly through an outlet 1710. The prosthetic valve 1000 can then be coupled to a valve retaining member 1110 of a delivery apparatus 1100, as described in more detail with respect to FIG. 37, or can be loaded directly into a sheath of the delivery apparatus, as described above with respect to the compression device 100.

[0147] 46 illustrates another example compression device 1800 including a housing 1802, an actuator 1804, and a pusher member 1806. The housing 1802 can be similar to the housing 108 described above, except as specifically noted. The actuator 1804 can include a base portion 1808 including one or more extension members or arms 1810, one or more springs 1812 (e.g., compression springs), and a locking member 1814. The actuator 1804 can be movably coupled to a pusher member 1806, such as or similar to the pusher member 112 described above, for holding the prosthetic valve (e.g., the prosthetic valve 1000) and for driving the prosthetic valve forward through a funnel segment 1818 of the housing 1802 and out an outlet 1820.

[0148] The pushing member 1806 can be coupled to the actuator 1804 via one or more springs 1812. In a particular example, the springs 1812 can be tension springs. The springs 1812 can be preloaded (e.g., to an extended state) such that when the springs 1812 return to their natural state, the springs 1812 contract to drive the pushing member 1806 (and thus the prosthetic valve 1000 disposed therein) forward into the housing 1802. The springs 1812 can have a stiffness such that they provide a pushing force greater than the elastic spring force provided by the prosthetic valve 1000. In other words, the springs 1812 can have a strength sufficient to drive the pushing member 1806 forward into the housing 1802 and compress the prosthetic valve 1000 despite the opposing spring force of the prosthetic valve 1000.

[0149] As discussed above, the actuator 1804 can further include a locking / stopping member 1814 configured to selectively hold the pusher member 1806 against movement relative to the housing 1802. For example, the stopping member 1814 can be an elongated rod extending between the arms of the pusher member 1806 (in instances where the pusher member 1806 is configured like the pusher member 112), or it can be a flat plate extending over the distal end of the pusher member 1806, or it can be an annular plate extending over the distal end of the pusher member 1806 but including an opening through which the pusher member can contact a prosthetic valve disposed within the housing. The stopping member 1814 can remain in place when the base portion 1808 drives the pusher member 1806 forward (i.e., based on compression of the spring 1812).

[0150] In use, the compression device 1800 can be used to compress a prosthetic valve (e.g., the prosthetic valve 1000 shown in FIG. 36 ) in the following exemplary manner: The prosthetic valve 1000 can be inserted into the funnel segment 1818 of the housing 1802. The actuator 1804 can be positioned adjacent to the inlet of the housing 1802, and the spring 1812 can be placed in tension (e.g., by pulling the base member 1808 away from the prosthetic valve 1000). The user can then release the base member 1808, allowing the spring 1812 to compress and return to an unloaded state, which drives the pusher member 1806 axially forward into the housing 1802. By driving the pusher member 1806 forward into the housing 1802, the prosthetic valve 1000 is forced through the funnel segment 1818 of the housing 1802, which radially compresses the prosthetic valve and forces it outwardly through the outlet 1820. The prosthetic valve 1000 can then be coupled to a valve retaining member 1110 of a delivery apparatus 1100, as described in more detail with respect to FIG. 37, or can be loaded directly into a sheath of the delivery apparatus, as described above with respect to the compression device 100.

[0151] 47 illustrates another example compression device 1900 that includes a housing 1902 and an actuator 1904. The housing 1902 can define an inner funnel segment 1908 that terminates at an outlet 1910 and can include one or more linear racks 1912 that include a plurality of inclined teeth 1914 extending axially along at least a portion of an inner surface 1916 of the housing 1902.

[0152] The actuator 1904 can be removably or permanently coupled to a pusher member 1906, such as the pusher member 112, or similar to the pusher member 1906. The pusher member 1904 and / or the actuator 1906 can include one or more pawl members 1918 configured to engage with the angled teeth 1914 of the housing 1902. The engagement of the one or more pawls 1918 with the teeth 1914 of the housing 1902 allows the actuator 1904 and the pusher member 1906 to be driven forward in a first axial direction relative to the housing 1902, but prevents the actuator and the pusher member from moving in an opposite second axial direction relative to the housing. This configuration allows the artificial valve to be compressed / squeezed while preventing the pusher member 1906 from being pushed out of the housing 1902 by elastic expansion of the artificial valve.

[0153] In use, the compression device 1900 can be used to compress a prosthetic valve (e.g., the prosthetic valve 1000 shown in FIG. 36 ) in the following exemplary manner: The prosthetic valve 1000 can be inserted into the housing 1902. The pusher member 1906 and the actuator 1904 can then be driven forward into the housing 1902 until the claw member(s) 1918 engage the teeth 1914, thereby aligning the pusher member 1906 with the prosthetic valve 1000, thereby engaging an adjacent end portion of the prosthetic valve 1000. The user can then continue to drive the actuator 1904 (and thus the pusher member 1906) axially forward into the housing. Driving the pusher member 1906 forward into the housing 1902 forces the prosthetic valve 1000 through the funnel segment 1908, thereby compressing the prosthetic valve radially and pushing it outwardly through the outlet 1910. The prosthetic valve 1000 can then be coupled to the valve retaining member 1110 of the delivery apparatus 1100, as described in further detail with respect to FIG. 37, or can be loaded directly into the sheath of the delivery apparatus, as described above with respect to the compression device 100.

[0154] 48, in another example, one or more linear racks 1912 can be disposed on an exterior surface 1920 of the housing 1902 instead of the interior surface 1916. In such an example, one or more corresponding pawls 1918 can be disposed on an extension member or arm 1922 extending from the actuator 1904.

[0155] 49A-49C illustrate another example compression device 2000. The compression device 2000 can include a housing 2002 (one half of which is shown in FIG. 49C) and an actuator 2004 (FIGS. 49A-49B). The housing 2002 can be similar to the housing 108 described above, except that the housing 2002 includes an exterior rib 2006 disposed on an exterior surface 2008 of the housing 2002. Although the illustrated example shows the housing 2002 including two halves (only one shown), in other examples the housing can be formed as a unitary member. The housing 2002 can define an inner funnel segment (not shown) articulated to an outlet 2010.

[0156] 49A-B, the actuator 2004 can include a base member or floor 2012, a C-shaped extension member 2014, and one or more ribs 2016 disposed on an inner surface of the extension member 2014 defining channels 2018 therebetween. The actuator 2004 can be configured as a clamping member such that when the actuator 2004 is driven forward on a first side and on a second side of the housing 2002, the actuator 2004 holds the sides together in an assembled configuration.

[0157] The actuator may further include an aperture 2020 extending through a thickness of the floor 2012. The aperture 2020 may be configured to couple to a pusher member, such as the pusher member 112, or to a pusher member similar to the pusher member 112. In the illustrated example, the aperture 2020 may have a non-circular shape (e.g., D-shaped). In such an example, the second end portion 164 of the pusher member 112 may have a cross-section of a corresponding non-circular shape such that when the pusher member 112 is inserted into the aperture 2020, the pusher member 112 is constrained from rotating relative to the actuator 2004. The pusher member 112 may be retained within the aperture 2020 using one or more resilient locking features / latches 174, as described above with respect to the compression device 100.

[0158] In use, the compression device 2000 can be used to compress a prosthetic valve (e.g., the prosthetic valve 1000 shown in FIG. 36 ) in the following exemplary manner: The prosthetic valve 1000 can be inserted into the housing 2002 (the housing halves can be held together by the user or by a collar or other means). The actuator 2004 can then be driven forward over the housing 2002 such that the ribs 2006 of the housing 2002 are positioned within the channels 2018 of the actuator 2004 and the pusher member 112 is aligned with the prosthetic valve 1000 to engage adjacent end portions of the prosthetic valve 1000. The C-shape of the actuator 2004 holds the two halves of the housing together when the housing 2002 is positioned within the actuator 2004. The user can then continue to drive the actuator 2004 axially along the exterior surface of the housing 2002, thereby driving the pusher member 112 axially into the housing. Driving the pusher member 112 axially into the housing 2002 forces the prosthetic valve 1000 through a funnel segment of the housing 2002, thereby radially compressing the prosthetic valve and pushing it outwardly through the outlet 2010. The prosthetic valve 1000 can then be coupled to a valve retaining member 1110 of the delivery apparatus 1100, as described in more detail with respect to FIG. 37, or can be loaded directly into a sheath of the delivery apparatus, as described above with respect to the compression device 100.

[0159] FIG. 50 illustrates another example compression device 2100 including a housing 2102, an actuator 2104, and a pushing member 2106. The housing 2102 can be similar to the housing 108 described above, except that the housing 2102 includes one or more engagement members 2108 disposed on an exterior surface 2112 of the housing and configured to engage with corresponding engagement members 2114 on the actuator 2104. For example, in some examples, the engagement members 2108 can be recesses / recesses / openings / detents in the exterior surface 2112 of the housing configured to receive corresponding protrusions / projections 2114 on the actuator 2104. In other examples, the engagement members 2108 can be magnets configured to couple with corresponding magnets 2114 on the actuator 2104.

[0160] The actuator 2104 can include a base member 2116 and one or more extension members 2118. The actuator 2104 can be coupled to a pusher member 2106, such as or similar to the pusher member 112 described above, for holding the prosthetic valve (e.g., the prosthetic valve 1000) and for driving the prosthetic valve forward through a funnel segment of the housing 2102 to an outlet 2120. In some examples, the pusher member 2106 and the actuator 2104 can be removably coupled together, and in other examples, they can be formed as a unitary member. As described above, the extension member 2118 can include a corresponding engagement member 2114 (e.g., a protrusion / projection and / or a magnet) configured to removably couple the actuator to the housing 2102. The engagement members 2108 on the housing 2102 can be positioned at selected axial locations along the length of the housing such that when the actuator 2104 and housing 2102 are coupled together, the prosthetic valve 1000 is in a selected compressed configuration (e.g., partial or full compression). In certain examples, the housing 2102 can include separable halves coupled together by a coupling member such as a ring or collar 2122. In other examples, the housing halves can be coupled together by interaction (e.g., physical or magnetic engagement) of the engagement members 2108 on the housing 2102 and the engagement members 2114 on the actuator 2104. In certain examples, the housing 2102 may also include multiple rows of engagement members 2108 spaced axially along the length of the housing 2102 and arranged circumferentially, thereby enabling the housing and actuator member 2104 to be releasably coupled together to the pusher member 2106 at different axial positions within the housing.

[0161] In use, the compression device 2100 can be used to compress a prosthetic valve (e.g., the prosthetic valve 1000 shown in FIG. 36 ) in the following exemplary manner: The prosthetic valve 1000 can be inserted into a funnel segment of the housing 2102. The actuator 2104 can then be driven forward relative to the housing 2102, which drives the pusher member 2106 axially forward into the housing and drives the extension member 2108 forward along the outer surface 2112 of the housing. In certain examples, the actuator 2104 can be driven into the housing 2102 without rotating or substantially rotating any of the components. Driving the pusher member 2106 forward into the housing 2102 forces the prosthetic valve 1000 through the funnel segment of the housing 2102, which radially compresses the prosthetic valve and pushes it outwardly through the outlet 2120. The prosthetic valve 1000 can then be coupled to the valve retaining member 1110 of the delivery apparatus 1100, as described in further detail with respect to FIG. 37, or can be loaded directly into the sheath of the delivery apparatus, as described above with respect to the compression device 100.

[0162] After the pusher member 2106 has been driven forward a selected amount into the housing 2102 (e.g., after the prosthetic valve 1000 has been driven forward at least partially through the outlet), the engagement member 2114 on the extension member 2118 can engage with the engagement member 2108 on the housing 2102, thereby releasably locking the actuator 2104 and the housing 2102 together. With this configuration, a user can release (e.g., move away) the compression device 2100 to connect the connection features of the prosthetic valve to the engagement features of the delivery apparatus without the prosthetic valve elastically expanding to push the pusher member 2106 out of the housing 2102.

[0163] 51 illustrates another example compression device 2200. The compression device 2200 can include a housing 2202, an actuator 2204, and a pushing member 2206. The actuator 2204 can be configured as a hydraulic actuator (e.g., similar to actuator 902) configured to use pressurized hydraulic fluid (e.g., water, oil, etc.) to drive the pushing member 2206 forward within the housing 2202. In a particular example, the hydraulic fluid can be pumped into the actuator 2202 using a fluid dispensing device 2208, such as a syringe.

[0164] The actuator 2204 can include a fluid chamber 2210 and a piston 2212. The piston 2212 can have a first end portion or shaft member 2214 coupled to the pusher member 2206 and a second end portion configured as a disk-shaped piston head 2216 having an outer periphery corresponding to the shape of the fluid chamber 2210. The piston head 2216 can be sized to move within the fluid chamber 2210 and to form a seal with the chamber wall such that fluid cannot leak through the periphery of the piston head 2216. In other words, the outer diameter of the piston head 2216 can be substantially equal to the inner diameter of the fluid chamber 2210. In some examples, the piston head 2216 can further include one or more O-rings or other sealing members 2218 disposed around the outer periphery of the piston head 2216 to help seal the piston head to prevent fluid from leaking through the periphery of the piston head. The fluid chamber 2210 of the actuator 2204 may be coupled to an inlet portion 2220 of the housing 2202 .

[0165] In the illustrated example, the chamber 2210 and the housing 2202 are cylindrical, although in other examples the fluid chamber can have any of a variety of shapes. The fluid chamber 2210 can include an inlet 2222 configured to fluidly couple (e.g., using flexible tubing 2224) to a fluid dispensing device 2208, a fluid reservoir, or a pump, such as a syringe, e.g., a high pressure syringe. In a particular example, the syringe can be an Atrion QL® syringe.

[0166] In use, the compression device 2200 can be used to compress a prosthetic valve (e.g., the prosthetic valve 1000 shown in FIG. 36 ) in the following exemplary manner: The prosthetic valve 1000 can be inserted into the housing 2202. The actuator 2204 can be coupled to the housing 2202. When so coupled, the pusher member 2206 can be aligned with the prosthetic valve 1000 and engaged against an adjacent end portion of the prosthetic valve 1000. A user can actuate the fluid reservoir 2208 (e.g., by depressing a plunger of a syringe or by activating a pump) to dispense a fluid (e.g., saline) into the fluid chamber 2210 via the inlet 2222. As the fluid chamber 2210 fills with fluid, the pressure drives the piston 2212 forward, which drives the pusher member 2206 axially forward into the housing 2202. By driving the pusher member forward into the housing, the prosthetic valve 1000 is forced through the funnel segment 2226 of the housing 2202, which radially compresses the prosthetic valve and forces it outwardly through the outlet 2228. The prosthetic valve 1000 can then be coupled to the valve retaining member 1110 of the delivery apparatus 1100, as described in more detail with respect to FIG. 37, or can be loaded directly into the sheath of the delivery apparatus, as described above with respect to the compression device 100. In certain examples, the working fluid can be a liquid, such as an aqueous liquid (e.g., saline), or can be a gas (e.g., a compressed inert gas such as nitrogen, carbon dioxide, etc.).

[0167] 52 illustrates another example compression device 2300. The compression device 2300 can include a housing 2302, an actuator 2304, and a pushing member 2306 (similar or the same as the pushing member 112 described above) coupled to the actuator 2304. The actuator 2304 can be configured to drive the pushing member 2306 forward into the housing 2302.

[0168] The housing 2302 may be similar to the housing 108 described above, except that the housing 2302 includes a threaded portion 2308 disposed on an inner surface of the housing 2302. The actuator 2304 may include a base member 2310 and a thumbscrew / threaded rod / actuator member 2312 configured to engage the threaded portion 2308 of the housing 2302. The actuator member 2312 may be positioned radially offset from a longitudinal axis of the pusher member 2306 and may be configured such that the actuator member 2312 may be rotationally driven about a longitudinal axis extending through the actuator member 2312.

[0169] In use, the compression device 2300 can be used to compress a prosthetic valve (e.g., the prosthetic valve 1000 shown in FIG. 36 ) in the following exemplary manner: The prosthetic valve 1000 can be inserted into the housing 2302. The pusher member 2306 can be aligned with the prosthetic valve 1000 such that it engages an adjacent end portion of the prosthetic valve 1000, and the actuator member 2312 is aligned with the threaded portion 2308 of the housing 2302. The user then rotationally drives the actuator member 2312 (e.g., using the grip portion 2314) to engage the actuator member 2312 with the threaded portion 2308 of the housing 2302. The thread engagement can translate rotational movement into axial movement (e.g., pushing) of the actuator 2304, and thus the pusher member 2306, which drives the pusher member 2306 axially forward into the housing 2302. Driving the pusher member 2306 forward into the housing 2302 forces the prosthetic valve 1000 through a funnel segment 2316 of the housing 2302, which radially compresses the prosthetic valve and pushes it outward through the outlet 2318 for coupling to a delivery apparatus. The prosthetic valve 1000 can then be coupled to the valve retaining member 1110 of the delivery apparatus 1100, as described in more detail with respect to FIG. 37, or can be loaded directly into the sheath of the delivery apparatus, as described above with respect to the compression device 100.

[0170] 53-63, as described above, after the prosthetic valve 1000 is initially coupled to the delivery device (e.g., to a valve retaining member), a separate loading assembly 2400 can be used to fully compress the prosthetic valve and load it into a capsule or sheath of the delivery device (e.g., sheath 2512 of delivery device 2500 shown in FIG. 57).

[0171] 53, the loading assembly 2400 can generally include a support tube 2402, a loading member / funnel member 2404, one or more fasteners / clamps 2406, and an annular tabring / retaining member 2408. The loading assembly 2400, or components thereof, can be configured to separate or open into multiple members, such as, for example, a clamshell, such that the loading assembly 2400 can be placed or assembled onto a delivery device and removed from the delivery device.

[0172] The support tube 2402 can include a first lateral side 2403a and a second lateral side 2403b. Each side 2402 can include a semi-cylinder such that when placed together they form a general cylindrical or tubular shape that defines an internal bore 2410 (FIG. 55). The support tube 2402 can have a main body 2412 having a first or inlet end portion 2414 and a second end portion 2416. Each of the sides 2402 can include mating features that aid in coupling the sides together. For example, as shown in FIG. 53, each side 2402 can include a protrusion / tab 2418 extending from a longitudinal edge 2420 of the side and a diametrically opposed recess 2422 formed in an opposing longitudinal edge 2421. Each tab 2418 can seat within a corresponding recess 2422 when the sides 2402 are joined together.

[0173] The inlet end portion 2414 may include an extension portion 2424 having an outer diameter smaller than the outer diameter of the main body 2412. The extension portion 2424 may be separated from the main body 2412 by an annular shoulder 2426. The inlet end portion 2414 may further include a recess 2428 configured such that an annular shoulder 2468 of the funnel member 2404 may be disposed within the recess 2428 when the funnel member is assembled onto the support tube 2402. In the illustrated example, the recess 2428 may have an arc shape that extends around a portion of the circumference of the support tube 2402.

[0174] The second end portion 2416 may include a first annular shoulder 2432 and a second annular shoulder 2434 extending radially from an outer surface of the main body 2412. Each side 2403 may include a diametrically opposed flange 2436 such that an inner surface of the flange 2436 on the first side 2403a may contact an inner surface of the flange 2436 on the second side 2403b when the sides are positioned adjacent to one another. The second end portion 2416 may further include one or more ribs 2438 (e.g., one rib in the illustrated example) extending longitudinally between the first shoulder 2432 and the second shoulder 2434.

[0175] The first side 2403a and the second side 2403b can be placed onto a shaft (e.g., shaft 2512) of a delivery device and then held or locked together using a first clamp 2406a. The sides 2403 can be held in an assembled position when a prosthetic valve (e.g., prosthetic valve 1000) is compressed and loaded into a capsule or sheath of the delivery device and then separated from one another after the prosthetic valve is loaded, allowing the loading assembly 2400 to be easily removed from the delivery device.

[0176] 56, each clamp 2406 may be a C-shaped member having a first end portion 2440 and a second end portion 2442. The clamp 2406 may have one or more shelves 2444 (e.g., two opposed shelves) extending radially inward from an inner wall of the free end portion of the clamp 2406 and extending along at least a portion of the length of the clamp. The second end portion 2442 may include a locking surface 2446 extending radially inward toward a longitudinal axis of the clamp 2406. The clamp 2406 may further include a first rib 2448 and a second rib 2448 extending radially inward from an inner surface of the clamp and extending longitudinally along the length of the clamp. The first rib 2448 and the second rib 2448 may define a channel 2450 therebetween. The channel 2450 can function as an alignment feature to orient the clamp member 2406 relative to the support tube 2402 (eg, in conjunction with the rib 2438 (FIG. 53) of the second end portion 2416 at the portion 2403a of the support tube).

[0177] Each clamp 2406 can further include one or more tabs 2452 extending radially outward from an outer surface of the clamp 2406. In the illustrated example, the tabs 2452 are diametrically opposed rectangular tabs, but in other examples, the tabs 2452 can have any of a variety of shapes and can be positioned anywhere around the circumference of the clamp. A force can be applied (e.g., manually by a user) against the tabs 2452 to drive the clamp 2406 forward over a portion of the support tube 2402 and / or over a portion of another component in the loading assembly 2400. In some examples, the clamp 2406 can include indicia 2454 (such as an arrow) that indicate in which direction the clamp 2406 should be driven forward over the part.

[0178] A first clamp member 2406a (see, e.g., FIG. 53) can be used to hold or lock the sides 2403 of the support tube 2402 in the assembled position. The first clamp 2406 can be aligned against the second end portion 2416 of the support tube 2402 such that the ribs 2438 are aligned against the channels 2450. The first clamp 2406a can then be driven axially forward over the second end portion 2416 of the support tube 2402 until the flanges 2436 engage against the locking surfaces 2446. The shelves 2444 can hold the sides 2403 within the clamp 2406a by holding the flanges 2436 together, as shown in FIGS. 54-55, thereby locking the sides 2403 in the assembled position.

[0179] 53, as described above, the loading assembly 2400 can include a retaining member 2408. The retaining member 2408 can be an annular member sized to fit over the extension 2424 of the support tube 2402. When the support tube 2402 is placed over the capsule / sheath of the delivery system, the retaining member 2408 can be driven forward over the extension 2424, as shown in FIG. 58, thereby retaining one or more tabs 2514 (FIG. 57) of the capsule 2512 in a folded-over position. In some examples, the capsule 2512 can be formed from one or more materials, such as PTFE, ePTFE, polyether block amide (Pebax®), polyetherimide (Ultem®), PEEK, urethane, Nitinol, stainless steel, and / or any other biocompatible material. In some particular examples, the capsule can include an outer polymer layer, a metallic intermediate layer disposed on the radially inner surface of the outer polymer layer, and an inner liner disposed on the radially inner surface of the intermediate layer. The tabs 2514 can be defined by spaced apart axially extending cuts extending circumferentially around the distal end portion of the capsule 2512. The tabs 2514 can be folded back (proximally) onto the capsule to facilitate insertion of an implant into the capsule and to facilitate bending of the distal end portion. Further details regarding the capsule can be found at least in U.S. Pat. No. 10,813,757, which is incorporated herein by reference in its entirety. The retaining member 2408 can advantageously maintain the tabs 2514 (FIG. 57) of the sheath 2512 in tension to maintain the capsule in a taut state, which can prevent or mitigate bending or deformation of the capsule in the direction of the prosthetic valve insertion / loading axis. The retaining members 2408 further function to help hold the sides 2403 of the support tube 2402 in the assembled position.

[0180] The funnel member 2404 can include a body portion 2456 and a funnel portion 2458. The funnel member 2404 can include a first side 2460 and a second side 2460 that, when assembled together, form a funnel member and define an interior bore extending along the length of the funnel member. The body portion 2456 can have a generally cylindrical shape when assembled. As shown in FIG. 58, the funnel portion 2458 can include an inlet end portion 2462 and an outlet end portion 2464 and can taper from a first diameter D1 at the inlet end portion 2462 to a smaller second diameter D2 where it joins the body portion (e.g., at the outlet end portion 2464). When assembled on the support tube 2402, the outlet of the funnel member 2404 can be positioned adjacent (e.g., distal to) the capsule 2512 and can be positioned to communicate with the interior of the capsule 2512. The body portion 2456 can include a first annular shoulder 2466 that articulates with the funnel portion 2458 and a second annular shoulder 2468. When assembled on the support tube 2402, the second annular shoulder 2468 can seat within a recess 2428 of the support tube, thereby restraining axial movement of the funnel member relative to the support tube. As seen most clearly in FIG. 53 , the second annular shoulder 2468 can include a notch 2470 configured to align with an anti-rotation feature configured as a protrusion or rib 2472 of the recess 2428 to prevent rotational movement of the funnel member 2404 relative to the support tube 2402.

[0181] Each side 2460 can include diametrically opposed flanges 2474 such that an inner surface of the flange 2474 on the first side 2460a contacts an inner surface of the flange 2474 on the second side 2460b when the sides are placed adjacent to one another. The flanges 2474 can be clamped together using a clamp 2406 to hold the funnel member 2404 in an assembled state. The funnel member 2404 can further include one or more ribs 2476 (e.g., one rib in the illustrated example) extending longitudinally along at least a portion of the length of the funnel member 2404. The ribs 2476 can function as alignment features in combination with the channel 2450 of the second clamp member 2406b to orient the second clamp member 2406b relative to the funnel member 2404.

[0182] The second clamp member 2406b can be used to hold or lock the sides 2460 of the funnel member 2404 in the assembled position, as shown in FIGS. 54-55. The second clamp 2406b can be aligned against the body portion 2456 of the funnel member 2404 such that the ribs 2476 are aligned with the channel 2450. The second clamp 2406b can then be driven axially forward on the body portion 2456 of the funnel member 2404 until the flanges 2474 contact the locking surfaces 2446, as shown in FIG. 58. The ledge 2444 can engage against the exterior surface of one or more of the flanges 2474 to hold the sides 2460 within the clamp 2406b, thereby locking the funnel member 2404 in the assembled position, as shown in FIGS. 54-55.

[0183] The loading assembly 2400 can be assembled onto a sheath or capsule 2512 of a delivery device 2500 (FIG. 57), and the loading assembly 2400 can be used to load a prosthetic valve (e.g., prosthetic valve 1000) into the capsule 2512 in the following exemplary manner: FIG. 57 illustrates a portion of an exemplary delivery device 2500 having a nosecone / tapered tip 2502, a first shaft 2504 configured as a guidewire lumen, a guidewire shield 2506, a valve retaining member 2508, a tubular retaining member hereinafter referred to as an outer ring 2510, which can be disposed on the shaft itself, and an outer shaft 2513, the distal end portion of which includes a capsule 2512 having a plurality of tabs 2514. Further details regarding delivery devices can be found at least in U.S. Pat. No. 10,813,757, which is incorporated herein by reference in its entirety. FIG. 58 shows the loading assembly 2400 positioned on the capsule 2512.

[0184] 58, the sides 2403 of the support tube 2402 can be placed over the capsule 2512, and the first clamp 2406a can be driven forward over the second end portion 2416 of the support tube 2402 (e.g., toward the inlet end portion 2414 of the support tube) to hold the support tube 2402 in the assembled position. The retaining member 2408 can be driven forward over the extension portion 2424 (FIG. 53) of the support tube (e.g., away from the inlet end portion 2414) to fold back the tab portion 2514 of the capsule 2512 so that the tab portion 2514 is held between the retaining member 2408 and the extension portion 2424. At this point in the assembly process, the loading assembly 2400 can be referred to as "partially assembled."

[0185] 60, after the loading assembly 2400 is partially assembled on the delivery device 2500, the compression device 100 (although compression device 100 is shown, any of the compression devices described above can be used) can be used to couple the prosthetic valve 1000 to the valve retaining member 2508, as described above. The capsule 2512 can be driven forward (e.g., using the handle of the delivery device 2500) until it contacts the compression device 100 (see, e.g., FIG. 61), and the prosthetic valve 1000 can be slowly withdrawn from the compression device 100. The capsule 2512 can then be retracted (e.g., using the handle of the delivery device) to ensure that the prosthetic valve 1000 is properly coupled to the valve retaining member 2508 while the actuator of the compression device is held in place. Thus coupled, the outer ring 2510 can be driven forward (e.g., using the handle of the delivery device) over the valve retaining member 2508 and over the portion of the prosthetic valve 1000 within the valve retaining member 2508 (e.g., the arm 1012 with the enlarged end portion 1014). In certain instances, the outer ring 2510 can prevent the enlarged end portion 1014 of the prosthetic valve frame from disengaging from the valve retaining member 2508. The partially assembled loading assembly 2400 can then be driven forward over the outer ring 2510 until the retaining member 2408 is positioned adjacent to the outlet end of the compression device 100, as shown in FIG. 61. The compression device 100 can then be removed from the delivery device, and the guidewire shield 2506 can be driven forward distally (e.g., using the advancement tool 2516) over the first shaft 2504 adjacent to the nosecone such that it is axially spaced from the prosthetic valve 1000, as shown in FIG.

[0186] 59 and 63, the sides 2460 (FIG. 53) of the funnel member 2404 can then be placed onto the retaining member 2408, causing the outer ring 2510 to be at least partially disposed within the funnel portion 2458. At this point, the loading assembly 2400 can be referred to as "fully assembled." The second clamp 2406b can be driven forward over the funnel member 2404 (e.g., in a direction toward the inlet end portion 2414 of the support tube 2402) to hold the funnel member 2404 in the assembled position. The capsule 2512 (and thus the attached loading assembly 2400) can then be driven forward over the prosthetic valve 1000 in the direction indicated by arrow 2518 using the handle of the delivery device 2500 (alternatively, the prosthetic valve can be retracted within the assembled capsule and loading assembly).

[0187] 64A , as the loading assembly 2400 is driven forward over the prosthetic valve 1000, the funnel portion 2458 radially compresses the prosthetic valve 1000, thereby allowing the prosthetic valve to be loaded into the capsule 2512. More particularly, as the capsule 2512 and loading assembly 2400 are driven forward over the prosthetic valve 1000, the anchors 1010 of the prosthetic valve 1000 may contact and be inverted by the funnel portion 2458, causing the prosthetic valve 1000 to transition to a substantially straight configuration in which the anchors 1010 extend distally from the main body 1003, rotated approximately 180° from the unconstrained configuration. With the tab member 2514 of the capsule 2512 folded proximally onto the capsule and held in place by the retaining member 2408, an opening in the distal end portion of the capsule can be maintained (e.g., by preventing the tab member 2514 from slipping past the retaining member 2408) when an implant is inserted into the capsule. The capsule 2512 can be maintained in tension or taut during loading of the implant, which can prevent it from buckling or bunching. The support tube 2402 can also provide structural support to the capsule 2512. In certain examples, the funnel portion 2458 can be filled with saline (e.g., provided from a port in the handle of the delivery device) during loading of the prosthetic valve. In certain examples, a free apex of the frame of the prosthetic valve can be guided into the funnel portion 2458 using, for example, the tool 1516.

[0188] 64B, when the outflow apices 1013 of the prosthetic valve 1000 frame are received within the funnel portion 2458, the guidewire shield member 2506 can be driven proximally forward along the guidewire shaft and positioned radially within the annular array of outflow apices 1013. In certain instances, the guidewire shield member 2506 can support the outflow apices 1013 of the prosthetic valve frame and maintain them in a selected orientation relative to the underlying guidewire shaft after the implant is fully compressed.

[0189] After the artificial valve 1000 is fully received within the capsule 2512, the loading assembly 2400 can be removed from the delivery device 2500 (e.g., by removing the first clamp 2406 and the second clamp 2406, as well as removing the sides 2460, 2403 of the funnel member 2404 and the support tube 2402).

[0190] With reference to FIG. 65, after the loading assembly 2400 is removed from the delivery device 2500, a trimmer guide member 2478 can be inserted into the distal end of the capsule 2512 to facilitate trimming of the capsule tab 2514 at a selected axial location, as shown in FIG. 67. With reference to FIGS. 70-71, the trimmer guide member 2478 can include a main body 2480 having a slot 2482. The slot 2482 can extend from a longitudinal axis of the main body to a radially outer surface 2484 of the main body. The main body 2480 can have a substantially cylindrical shape with a rounded end portion 2486 and a beveled end portion 2488. The main body 2480 can include an annular notch or groove 2490 extending circumferentially about the main body 2480. The trimmer guide member 2478 can further include an arm member / guide arm 2492 having a radially extending portion 2494 and an axially extending portion 2496 that extends toward the rounded end portion 2486. As can be seen most clearly in FIG. 71 , the axially extending portion 2496 of the guide arm 2492 can have a selected length such that an end face 2498 of the axially extending portion 2496 is axially aligned with the groove 2490.

[0191] 65-69, the trimming guide member 2478 (which may also be referred to as a "trimmer device") can be placed on the first shaft 2504 of the delivery apparatus 2500 by inserting the first shaft 2504 into the slot 2482. The trimming guide member 2478 can then be driven forward into the distal end portion 2520 of the capsule 2512 until the rounded end portion 2486 abuts against the guidewire shield member 2506 within the capsule 2512 and / or against the prosthetic valve 1000. As shown in FIG. 66, the guide arm 2492 can extend over the exterior surface of the capsule 2512 (e.g., between the tabs 2514). As shown in FIG. 67, a user can position the blade 2522 of a cutting tool 2524 (e.g., scalpel) such that a first surface 2526 (e.g., side surface) of the blade 2522 contacts the end surface 2498 of the axially extending portion 2496 of the guide arm 2492. With the blade 2522 contacting the end surface 2498, the user can advance the cutting edge of the blade radially inward toward the longitudinal axis of the capsule 2512 until the cutting edge is disposed within the groove 2490 of the trimming guide member 2478. The user can rotate the capsule 2512 relative to the blade 2522 (or vice versa) while applying cutting pressure with the cutting edge held within the groove 2490 to cut open the capsule 2512 and remove the tab 2514, as shown in FIG. 68. This allows the user to cut the wall of the capsule 2512 without damaging the internal components contained within the capsule.

[0192] The cut capsule segment 2528, including the plurality of tabs 2514, can then be removed from the remainder of the capsule body 2530, such as by manually tearing the cut segment 2528 from the remainder of the body 2530. The capsule 2512 can be cut again, if necessary (e.g., to finish the distal edge 2532), using the cutting instrument 2524 and trimmer guide member 2478. The trimmer guide member 2478 can then be removed.

[0193] 69, the nosecone 2502 can be retracted proximally (as represented by arrow 2534) until the proximal edge 2536 of the nosecone 2502 abuts against the distal edge 2532 of the capsule 2512. Use of the trimmer guide member 2478 advantageously minimizes the gap between the capsule 2512 and the nosecone 2502 by using an end of the loaded prosthetic valve 1000 as a starting point for cutting the capsule 2512. Additionally, the trimmer guide member 2478 advantageously prevents or mitigates the risk of damage to the nosecone 2502, capsule 2512, and / or prosthetic valve 1000 during cutting.

[0194] 72 illustrates an alternative example trimmer guide member 2600. The trimmer guide member 2600 may be similar to the trimming guide member 2478 (e.g., having a body main 2602 with a slot 2604, a rounded end portion 2606, and an annular groove 2610, and a guide arm 2608 with a radially extending portion 2612 and an axially extending portion 2614), except that the trimmer guide member 2600 does not include a beveled end portion. The trimmer guide member 2600 may have an elongated main body 2602 as compared to the main body 2480 of the trimmer guide member 2478.

[0195] 73 illustrates another alternative example trimmer guide member 2700. The trimmer guide member 2700 may be similar to the trimmer guide member 2478 (e.g., having a main body 2702 with a slot 2704, a rounded end 2706, and an annular groove 2708, and a guide arm 2710), except that the trimmer guide member 2700 further includes an arc member 2712 coupled to an axially extending portion of the guide arm 2710. The arc member 2712 may be a C-shaped member having a proximal surface 2714 aligned with the groove 2708 in the main body 2702. In this example, advantageously, a user can press the side of the blade against the arc member 2712 while cutting along the periphery of the capsule 2512 without having to rotate the capsule 2512 and / or the trimmer guide member 2700 relative to one another. Any of the example trimmer guide members described herein may be used in combination with the example compaction assemblies.

[0196] In certain examples, the halves of the support tube 2402 can be arranged in a parallel configuration and can act as a support for the delivery device and / or the distal end of the capsule 2512 during the cutting process described above.

[0197] After the prosthetic valve 1000 is loaded into the capsule 2512 of the delivery system 2500, the surgeon can insert a guidewire into the patient and reach a selected treatment site, such as the native mitral valve. The delivery system can be introduced into the patient's vasculature and driven over the guidewire to the native mitral valve. The surgeon can then position the capsule 2512 at a selected location relative to the annulus of the native mitral valve and deploy the prosthetic valve within the annulus of the native mitral valve, for example, by withdrawing the capsule from over the prosthetic valve and / or by driving the prosthetic valve distally out of the capsule to expand the prosthetic valve into its functional configuration and regulate blood flow through the mitral valve. In certain examples, the surgeon can manipulate the delivery device to disengage the prosthetic valve from the valve retention feature(s) located at the distal end of the shaft. The delivery device and guidewire can then be withdrawn from the patient. The example delivery devices and implants described herein can also be used to replace the function of other natural heart valves, such as the aortic, tricuspid, or pulmonary valves.

[0198] 77-80, in some examples of the loading assembly 2400, a flexible tabling / retaining member 2800 can be used in place of or in addition to the annular tabling / retaining member 2408. All other components in the loading assembly 2400 can remain the same unless otherwise noted. As shown in FIGS. 77-78, the flexible retaining member 2800 can be used in the same manner as the retaining member 2408, i.e., by fitting over the extension 2424 (see FIG. 53) of the support tube 2402 to hold the tabs 2514 of the sheath / capsule 2512 in tension to hold the capsule 2512 in a taut state, which can prevent or mitigate bending or deformation of the capsule during insertion / loading of the prosthetic valve. The retaining member 2800 further functions to help hold the sides 2403 of the support tube 2402 in the assembled position.

[0199] The flexible retaining member 2800 can be an annular member including a main body 2802 defining a lumen or bore 2810 extending therethrough. The main body 2802 has a sinusoidal / wave-shaped cross-section including a number of peaks 2804 and valleys 2806. In other examples, the flexible retaining member 2800 can have a zigzag shape. The shape of the flexible retaining member 2800 allows the retaining member 2800 to be inserted onto and removed from the extension portion 2424 with less force than would be required for a rigid retaining member. In some examples, the force required can be reduced by up to 50%. For example, if an insertion force of about 20 lbf (about 89.0 N) and a removal force of about 12 lbf (about 53.4 N) are required for a rigid retention member, the flexible retention member 2800 can be inserted with about 10 lbf (about 44.5 N) and removed with about 6 lbf (about 26.7 N).

[0200] 81-83, after loading a prosthetic valve (such as the prosthetic valve 1000 described above) into the distal end of the capsule 2512 as described above, the capsule tab 2514 can be cut from the capsule 2512 such that the proximal end 2536 of the nosecone 2502 can be abutted against the distal end 2532 of the capsule 2512, such as shown in FIG. 69. In some examples, a trimming device 2900 including an integrated cutting edge / blade can be used in place of a cutting instrument such as a scalpel as described above. The trimming device 2900 can be used in combination with a trimmer guide member 2478 to cut the tab 2514 from the capsule 2512, as shown in FIGS. 82-83. The trimming device 2900 is configured to rotate about the capsule 2512, thereby advantageously allowing a single operator to cut the capsule tab 2514.

[0201] 81, the trimming device 2900 can include a main body 2902, a platform member 2904, and a detachable blade 2906 having a cutting edge 2908. The main body 2902 can be an annular member defining a central lumen / bore 2910 extending through a thickness of the main body 2902. The central bore 2910 can be configured (e.g., sized and shaped) such that a capsule 2512 can be disposed within the central bore 2910, as shown in FIGS. 82-83. The main body 2902 can include a notch 2912 extending radially outward from the central bore 2910 to a radially outer edge 2914 of the main body 2902. The platform member 2904 can be coupled to a first surface 2916 of the main body, and the blade 2906 can be disposed on the platform member 2904. The platform member 2904 can include a lip or edge portion 2918 that is configured to retain the blade 2906 on the platform member 2904 and to position the blade 2906 so that the cutting edge 2908 extends slightly into the central hole 2910. In some examples, the platform member 2904 can be configured (e.g., sized and shaped) to be compatible with a standard razor such that the blade 2906 can be easily removed and replaced when desired.

[0202] In use, as shown in FIGS. 82-83, the trimmer guide member 2478 can be placed on the first shaft 2504 by inserting the first shaft 2504 into the slot 2482 (FIG. 82). The trimmer guide member 2478 can then be driven forward into the distal end portion of the capsule 2512 until the rounded end portion 2486 (FIG. 65) abuts against the guidewire shield member 2506 and / or the prosthetic valve 1000 within the capsule 2512. As shown in FIG. 82, the guide arm 2492 can extend over an exterior surface of the capsule 2512 (e.g., between the tabs 2514).

[0203] As shown in FIGS. 82-83, a user can position the trimming device 2900 so that the first surface 2920 of the blade 2906 contacts the end surface 2498 of the guide arm 2492. The trimming device 2900 can then be driven forward toward the capsule 2512 until the cutting edge 2908 of the blade 2906 is disposed within the groove 2490 (FIG. 70) of the trimmer guide member 2478. While holding the cutting edge 2908 within the groove 2490, the user can rotate the trimming device 2900 relative to the capsule 2512 (or vice versa) and apply a cutting pressure to cut the capsule 2512 and remove the tab 2514. This allows the user to cut the wall of the capsule 2512 without damaging the internal components contained within the capsule. This configuration advantageously allows a single user to easily cut the tab 2514 from the capsule, for example, by holding the capsule 2512 with one hand while rotating the trimming device 2900 with the other. Additionally, this configuration advantageously allows the tab 2514 to be removed by simply rotating the trimming device 2900 360 degrees around the capsule 2512.

[0204] The cut capsule segment, including the tabs 2514, can be removed from the remainder of the body of the capsule 2512, such as by manually tearing the cut segment 2528 from the capsule. The capsule 2512 can be cut again, if necessary (e.g., to finish the distal edge), by again using the trimming device 2900. The trimmer guide member 2478 can then be removed.

[0205] 84-87, in some examples, the tab 2514 of the capsule 2512 can be removed using a trimming device 3000 without the need for the trimmer guide member 2478 or a separate cutting instrument such as a scalpel. After a prosthetic valve (e.g., the prosthetic valve 1000 described above) is loaded into the capsule 2512, the trimming device 3000 can be used to remove the capsule tab 2514 from the capsule 2512, thereby abutting the proximal edge 2536 of the nose cone 2502 against the distal edge 2532 of the capsule 2512, such as shown in FIG. 69. The capsule 2512 can include a soft composite material with lubricating properties, such as expanded polytetrafluoroethylene EPTFE, in some examples. This can make it difficult to cut the capsule without generating strands / edge debris / burr debris / particulates. The trimming devices described herein (including those described above) prevent and / or mitigate these problems.

[0206] 84, the trimming device 3000 may generally include a housing 3002 including a main body 3004 and a support extension member 3006, a rotatable member 3008, and a blade holder 3010 (FIG. 86) coupled to the rotatable member 3008. As shown in FIG. 86, the blade holder 3010 may be configured to hold a blade 3012 having a cutting edge 3014 including a sharp point 3016.

[0207] 84, the main body 3004 may include a generally cylindrical shape defining an annular inner chamber within which the rotatable member 3008 is disposed. The main body 3004 may include a cutout 3018 through which the rotatable member 3008 can be viewed and actuated when the rotatable member 3008 is positioned within the main body 3004. The cutout 3018 may be shaped as a cylindrical portion in some examples.

[0208] As described above, the housing 3002 can further include a support extension member 3006. The support extension member 3006 can be coupled to and extend from the first surface 3020 of the main body 3004. In some examples, such as the illustrated example, the support extension member 3006 can include one or more legs or support members 3022. The support member 3022 can allow the trimming device 3000 to be positioned on a work surface, such as a table, to facilitate use by a single operator. In some examples, the support member 3022 can include an angled portion 3024. The angled portion 3024 can be configured to position a distal end portion 3026 of the trimming device (including the main body 3004 and the rotatable member 3008) on a second surface to extend the working length of the device. In some examples, such as that shown in FIG. 84, the support member 3022 can include a recess in its outer surface that is configured to allow a user to position the thumb (or other finger) within the recess to facilitate holding the trimming device 3000 during use.

[0209] As shown in FIG. 84, the support extension member 3006 can include a central channel or recess 3028. The central recess 3028 can be configured (e.g., sized and shaped) such that the capsule 2512 can be disposed therein, such as shown in FIG. 85. The trimming device 3000 can further include a lid or clamp member 3030 pivotally coupled to the support extension member 3006 via one or more hinges 3032. The clamp member 3030 can be transitional between an open position ( FIG. 84 ) and a closed position in which the clamp member 3030 is configured to mitigate movement of the capsule 2512 relative to the support extension member 3006. The clamp member 3030 can include a central channel or recess 3034 such that the capsule 2512 is disposed within the recess 3028 and within the recess 3034 when the clamp member 3030 is in the closed position.

[0210] The trimming device 3000 can include one or more alignment features 3036 configured to be aligned with corresponding alignment feature(s) 2515 on the capsule 2512 such that when the capsule 2512 is positioned within the recess 3028, a selected cutting location at a distal end portion of the capsule 2512 is aligned with the blade 3012. As shown in FIG. 84 , the recess 3028 and the clamping member 3030 together can include a first alignment feature 3036. In the illustrated example, the alignment feature 3036 can include a first laterally extending groove / channel 3038a and a second laterally extending groove / channel 3038b disposed in the recess 3028 and the clamping member 3030, respectively. In some examples, the alignment feature 3036 can be, for example, a gripping member configured to frictionally engage an outer surface of the capsule 2512.

[0211] 85, when the capsule 2512 is placed within the recess 3028, the alignment feature 2515 (e.g., the flared / tapered portion of the capsule 2512) seats within the alignment feature 3036. The alignment feature 3036 thus aligns the capsule 2512 such that a selected cutting location (e.g., proximal to the tab 2514) is aligned with the blade 3012. The clamping member 3030 can then be driven to a closed position to prevent or mitigate against displacement of the capsule 2512 during the cutting process.

[0212] In some examples, such as the illustrated example, the trimming device 3000 can include a second alignment feature 3042. The second alignment feature 3042 can be located at a proximal end portion 3044 of the trimming device 3000 and can be configured to engage the connector 2517 (FIG. 85) of the capsule 2512. The second alignment feature 3042 can prevent movement of the capsule 2512 relative to the trimming device 3000 and / or can help ensure that the capsule 2512 is positioned within the trimming device with the selected cutting location aligned with the blade 3012. In the illustrated example, the second alignment feature 3042 (FIG. 84) is a laterally extending groove / channel sized to seat a portion of the connector 2517 therein. However, in other examples, the second alignment feature can be, for example, a gripping member disposed within a recess and / or disposed within a clamping member and / or disposed within an additional clamping member, which gripping member is configured to frictionally engage with an outer surface of the connector 2517 and / or with an outer surface of the capsule 2512.

[0213] 86, the blade holder 3010 can include a main body 3046, which includes a blade engaging member 3048 and an opening 3050. The blade engaging member 3048 includes a first member 3052 extending from one side of the main body, and a removable second member 3054 configured to be disposed between the first member 3052 and the blade 3012 to hold the blade 3012 against the main body 3046 of the blade holder 3010. This configuration allows the blade 3012 to be easily replaced when the cutting edge 3014 becomes dull. The first member 3052 and the second member 3054 can be coupled to each other to prevent movement of the second member 3054 or the blade 3012 relative to the blade holder 3010. For example, as shown in FIG. 86, the second member 3054 can have a U-shape so that it can slide under and around the first member 3052, although in other examples, the first member 3052 and the second member 3054 can have any of a variety of interlocking shapes.

[0214] 87-88 illustrate the rotatable member 3008 and blade holder 3010 with other components of the trimming device 3000 removed for purposes of illustration. As shown in FIG. 87, the rotatable member 3008 may generally include a main body 3056, a ratchet member 3058, and a door member 3060. The rotatable member 3008 may define a central lumen or bore 3062 extending through a thickness of the main body. The central bore 3062 may be configured (e.g., sized and shaped) such that a distal end portion of the capsule 2512 may be positioned within the bore 3062 such that a selected cutting location is aligned with respect to the blade 3012.

[0215] The door member 3060 can be movable between an open position ( FIG. 87 ) and a closed position ( FIG. 88 ). The rotatable member 3008 can be configured such that movement of the door member 3060 from the open position to the closed position drives the blade 3012 from a first safety / non-cutting / retracted position ( FIG. 87 ) to a second cutting / extended / use position ( FIG. 88 ) with the cutting edge 3014 of the blade 3012 extending into the central bore 3062 as shown in FIG. 88 . For example, the door member 3060 can be coupled to the blade holder 3010 via a cam member 3064. The cam member 3064 may have an elongated C-shape and may be pivotally coupled to the door member 3060 at a first end portion 3066 (e.g., via fastening members 3068) and to the blade holder 3010 at a second end portion 3070, for example, using fastening members 3068 extending through openings 3050 in the blade holder 3010.

[0216] In some examples, the door member 3060 can further include a locking member that can be actuated between a locked position in which the door member is held in either a closed or open position, and an unlocked position in which the door member is movable between the locked and unlocked positions.

[0217] As shown in Figs. 87-88, when the door member 3060 moves from the open position to the closed position, the first end portion 3066 of the cam member 3064 moves radially away from the central bore 3062, which causes a corresponding movement of the second end portion 3070 of the cam member 3064, thereby driving the blade holder 3010 from the retracted position (Fig. 87) to the use position (Fig. 88). Such an arrangement advantageously prevents injury to the user and prevents inadvertent damage to the capsule 2512 by ensuring that the cutting edge 3014 of the blade 3012 does not contact the capsule 2512 until the door is closed. This prevents accidental cutting when the capsule is not in the selected position. In another example, the blade holder 3010 can be coupled to a manually actuable member, such as a button, which allows a user to select when to actuate the blade from the retracted position to the use position. 89 to 95 illustrate such examples.

[0218] Referring again to FIG. 87, the ratchet member 3058 may be coupled to the main body 3056 of the rotatable member 3008 and may include a plurality of teeth 3072. The teeth 3072 may be arranged in a circular pattern around the circumference of the ratchet member 3058. The plurality of teeth 3072 may be configured to engage a pawl (see, for example, pawl 3150 in the example shown in FIG. 91, which functions similarly) of the main body 3004 such that the rotatable member 3008 may rotate in a first direction (e.g., clockwise in the orientation shown in FIG. 87) but is prevented from rotating in a second direction (e.g., counterclockwise in the orientation shown in FIG. 87). In some examples, the pawl may include a biasing member, such as a spring, configured to bias the pawl against the plurality of teeth 3072.

[0219] 85, in use, the capsule 2512 can be positioned within the trimming device 3000 with the alignment feature 2515 of the capsule 2512 aligned with the first alignment feature 3036 and the connector 2715 aligned with the second alignment feature 3042 (FIG. 84). The clamping member 3030 can then be actuated from the open position (FIG. 85) to the closed position to hold the capsule in place. This positions a selected cutting location (e.g., proximal to the tab 2514) in alignment with the cutting edge 3014 of the blade 3012. Thus aligned, by driving the door member 3060 from the open position (FIG. 87) to the closed position (FIG. 88), the blade holder 3010 (and thus the blade 3012) can be driven from the retracted position to the use position by driving the cam member 3064, and the tip 3016 of the blade 3012 can be inserted through the wall of the capsule 2512. The capsule 2512 can then be cut by driving the rotatable member 3008 through 360 degrees to remove the tab 2514. The positioning of the blade 3012 as determined by the movement of the cam member 3064 allows a user to cut the wall of the capsule 2512 without damaging the internal components contained within the capsule. This configuration advantageously allows, for example, a single user to easily cut the tab 2514 from the capsule by positioning the capsule 2512 within the trimming device 3000 and then driving the rotatable member 3008. Additionally, this configuration advantageously allows the tabs 2514 to be removed with a single 360 ​​degree rotation of the rotatable member 3008, which may speed up the process and avoid the need for additional trimming.

[0220] 89-95 illustrate another example trimming device 3100. The trimming device 3100 may be similar to the trimming device 3000 described above, except where otherwise indicated. That is, the trimming device 3100 may generally include a housing 3102 including a main body 3104 and a support extension member 3106, a rotatable member 3108, and a blade holder 3110 (FIG. 91) coupled to the rotatable member 3108 and including a blade 3112. It should be noted that any features described herein with respect to the trimming device 3100 may be used with the trimming device 3000, and vice versa.

[0221] Instead of the cam member 3064 described above that positions the blade holder 3010 based on the position of the door member 3060, the trimming device 3100 includes an actuator member 3114, such as a button, that allows a user or the like to manually determine the position of the blade holder 3110. With reference to FIGS. 94-95, the actuator member 3114 may be positioned adjacent to a central bore 3116 of the rotatable member 3108 and may be coupled to the blade holder 3110. The actuator member 3114 may be movable between a first position in which the blade holder 3110 is in a safe / non-cutting / locked / retracted position (FIG. 94) and a second position in which the blade holder (and thus the blade 3112) is in a cutting / extended / use position (FIG. 95). When in the use position, the cutting tip 3118 and cutting edge of the blade 3120 extend into the central bore 3116 of the rotatable member 3108. In some examples, the actuator member 3114 can include a biasing member (such as a spring) configured to bias the actuator member 3114 towards the first position.

[0222] 91-92, in some examples, when in the first position (also referred to as the locked position), the actuator member 3114 can prevent rotation of the rotatable member 3108. Such a configuration can advantageously facilitate loading of the capsule 2512 into the trimming device 3100 by preventing inadvertent rotation of the rotatable member 3108. For example, the main body 3104 of the housing 3102 can include a notch 3122 that defines one or more shoulders 3124. The actuator member 3114 (which is slidably coupled to the rotatable member 3108) can include a protrusion 3126 that seats within the notch 3122 when the actuator member 3114 is in the first position, as shown in FIG. 92. Engagement of the protrusion 3126 with the one or more shoulders 3124 prevents rotation of the rotatable member 3108 relative to the main body 3104. When the actuator member 3114 moves from the first position (FIG. 94) to the second position (FIG. 95, also referred to as the unlocked position), the protrusion 3126 is no longer disposed within the notch 3122 and the rotatable member 3108 can rotate relative to the main body 3104.

[0223] In some examples, the trimming device 3100 can include a detent mechanism 3128 configured to hold the door member 3130 in a closed position during operation of the trimming device 3100. With reference to FIG. 90, the door member 3130 can include a protrusion / projection / detent 3132 configured to seat within an aperture / opening 3134 in the main body 3136 of the rotatable member 3108 when the door member 3130 is located in the closed position (see FIG. 94). Engagement of the detent 3132 and the opening 3134 can selectively hold the door member 3130 in the closed position until sufficient force is applied (e.g., manually by a user) against the door member 3130 to open the door member. In the illustrated example, the detent 3132 is a hemispherical protrusion and the opening 3134 has a corresponding circular shape, although in other examples the detent and opening can have any of a variety of corresponding shapes.

[0224] 93, the trimming device 3100 can include a first clamping member 3138 and a first alignment feature (not shown), similar to the clamping member 3030 and alignment feature 3036 described above. The trimming device 3100 can further include a second clamping member 3140 positioned at a proximal end portion 3142 of the housing 3102. The second clamping member 3140 can be pivotally coupled (such as via one or more hinges) to the support extension member 3106 and can be movable between an open position (FIG. 93) and a closed position (FIG. 89). The second clamping member 3140 can be configured to engage the connector 2517 to prevent movement of the capsule 2512 relative to the trimming device 3100. In some examples, the second clamping member 3140 can include a groove or recess sized to hold the connector 2517, and in some examples, the second clamping member 3140 can include a gripping member configured to frictionally engage against an outer surface of the connector 2517 and / or against an outer surface of the capsule 2512.

[0225] 89, the support extension member 3106 of the housing 3102 can include a first portion 3144 and a second portion 3146 that are telescopically movable relative to one another, thereby allowing the overall length of the support extension member 3106 to be adjustable. This advantageously allows the second clamp member 3140 to be positioned in alignment with the connector 2517 of the capsule 2512 (or in alignment with a selected location on the capsule 2512). Additionally, because the capsule 2512 may be longitudinally compressed during the loading process, it is advantageous to have the length of the housing 3102 adjustable to ensure that the second clamp member 3140 engages the connector 2517 to prevent or mitigate unintended translation of the capsule 2512 within the trimming device 3100.

[0226] As shown in FIG. 91, the trimming device 3100 can include a ratchet pawl mechanism configured to allow the rotatable member 3108 to rotate only in a first direction (e.g., counterclockwise in the orientation shown in FIG. 91) while preventing rotation in a second direction (e.g., clockwise in the orientation shown in FIG. 91). The rotatable member 3108 can include a plurality of teeth 3148 arranged in a circular pattern on the rotatable member 3108, and the main body 3104 of the housing 3102 can include a pawl 3150 having an end portion configured to engage with the teeth 3148. The teeth 3148 can be angled such that the pawl 3150 slides along the teeth to allow rotation of the rotatable member 3108 in the first direction while preventing rotation of the rotatable member in the second direction via engagement of the corresponding teeth 3148 and pawl 3150.

[0227] In use, the capsule 2512 can be placed inside the trimming device 3100, and the first clamping member 3138 can be actuated from an open position to a closed position (FIG. 89) to hold the capsule 2512 in place and position the capsule 2512 such that the cutting position is aligned with the cutting edge of the blade 3112. The second portion 3146 of the support extension member 3106 can be actuated (e.g., slid) relative to the first portion 3144 to align the second clamping member 3140 with the connector 2517 of the capsule 2512. The second clamping member 3140 can be actuated to a closed position (see, e.g., FIG. 89) to prevent translational movement of the capsule 2512 relative to the trimming device 3100. With this alignment, the door member 3130 can be pivoted from an open position (FIG. 90) to a closed position (FIG. 89). The detents 3132 may be engaged against the openings 3134 to hold the door member 3130 in the closed position.

[0228] The actuator member 3114 can then be actuated from the first / locked position to the second / unlocked position, which actuates the blade holder 3110 (and thus the blade 3112) to a use position, which allows the tip 3118 of the blade 3112 to be inserted through the wall of the capsule 2512. The rotatable member 3108 can then be rotationally actuated through 360 degrees to circumferentially cut the capsule 2512 and remove the tab 2514. The positioning of the blade 3112 as determined by the movement of the actuator member 3114 allows a user to cut the wall of the capsule 2512 without damaging internal components contained within the capsule. This configuration advantageously allows a single user to easily cut the tab 2514 from the capsule, for example, by positioning the capsule 2512 within the trimming device 3100 and then rotationally actuating the rotatable member 3108. Additionally, this configuration advantageously allows the tabs 2514 to be removed with a single 360 ​​degree rotation of the rotatable member 3108, which may speed up the process and avoid the need for additional cutting.

[0229] 96-97 illustrate another example trimming device 3200. The trimming device 3200 may be similar to the trimming devices 3000, 3100 described above, except where otherwise indicated. That is, the trimming device 3200 may generally include a housing 3202 including a main body 3204 and a support extension member 3206, a rotatable member 3208, and a blade holder 3210 (FIG. 97). It should be noted that any features described herein with respect to the trimming device 3200 may be used with the trimming devices 3000 and / or 3100, and vice versa.

[0230] The trimming device 3200 may further include a first clamp member 3212 (similar to the clamp member 3030 and alignment feature 3036 described above) having a first alignment feature 3214 and a second clamp member 3216 coupled to a second end portion 3218 of the housing 3102, the second clamp member 3216 being movable in a telescopic manner relative to the first portion 3220, thereby allowing the overall length of the support extension member 3206 to be adjusted.

[0231] 96, the first portion 3220 of the support extension member 3206 may include a linearly extending recess 3222. The first clamping member 3212 may include a corresponding linear protrusion extending along an inner surface of the clamping member 3213. When the clamping member 3212 is in the closed position, the protrusion may be disposed within the recess 3222 to prevent inadvertent opening of the first clamping member 3212. The first clamping member 3212 may be opened by applying a radially outward force (relative to the longitudinal axis of the trimming device 3200) to the clamping member 3212 to displace the protrusion from the recess 3222 to open the clamping member 3212.

[0232] The rotatable member 3208 can include a door member 3224 having a slide-fit / snap-fit / press-fit configuration with a main body 3226 of the rotatable member 3208. For example, as shown in FIG. 97, the door member 3224 can include a linear protrusion 3228 configured to be received within a slot 3230 in the main body 3226.

[0233] The trimming device 3200 includes an actuator member 3232, such as a button, that allows a user or the like to manually determine the position of the blade holder 3210. The actuator member 3232 may be movable between a first position in which the blade holder is in a safe / non-cutting / locked / retracted position (FIG. 97) and a second position in which the blade holder 3210 (and thus the blade disposed therein) is in a cutting / extended / use position. When in the use position, the cutting tip and cutting edge of the blade extend into a central bore of the rotatable member 3208 such that when a capsule 2512 is disposed within the central bore, the cutting edge of the blade pierces the capsule. As shown in FIGS. 96-97, the actuator member 3232 may include a biasing member 3234 (such as a spring) configured to bias the actuator member 3232 to the first position.

[0234] In some examples, such as the illustrated example, the actuator member 3232 can be a first actuator member and the trimming device 3200 can further include a second actuator member 3236. The actuator member 3236 can be configured to retract the blade holder 3210 (and thus the blade) from the use position to the retracted position. The second actuator member 3236 can be, for example, a button, a knob, a sliding member, etc. In some examples, the second actuator member 3236 can release a catch, thereby allowing the blade holder 3210 to be lifted from the use position.

[0235] As shown in FIG. 97, the trimming device 3200 can include a ratchet pawl mechanism configured to allow the rotatable member 3208 to rotate only in a first direction (e.g., counterclockwise in the orientation shown in FIG. 97) while preventing rotation in a second direction (e.g., clockwise in the orientation shown in FIG. 97). The rotatable member 3208 can include a number of teeth 3238 disposed about an outer periphery of the rotatable member 3208, and the main body 3204 of the housing 3202 can include a pawl 3240 having an end portion configured to engage with the teeth. The teeth 3238 can be angled such that the pawl 3240 slides along the teeth to allow rotation of the rotatable member 3208 in the first direction while preventing rotation of the rotatable member in the second direction via engagement of the corresponding teeth 3238 and pawl 3240.

[0236] In use, a user can position the capsule 2512 inside the trimming device 3200 with the alignment feature 2515 of the capsule 2512 aligned with the first alignment feature 3214 and the connector 2517 aligned with the second clamping member 3216, as shown in FIG. 96. The first clamping member 3212 can then be actuated from the open position (FIG. 96) to the closed position to hold the capsule 2512 in place and position the capsule with the cutting edge aligned with the cutting edge of the blade. Actuating the second clamping member 3216 to the closed position can prevent translational movement of the capsule 2512 relative to the trimming device 3200. With this alignment, the first actuator member 3232 can be actuated to actuate the blade holder 3210 (and thus the blade) to the use position, allowing the pointed tip of the blade to be inserted through the wall of the capsule 2512. By rotationally driving the rotatable member 3208 through 360 degrees, the capsule 2512 can be cut circumferentially to remove the tab 2514. The positioning of the blade as determined by the movement of the actuator member 3232 allows the user to cut the wall of the capsule 2512 without damaging the internal components contained within the capsule. After the tab 2514 has been removed, the second actuator member 3236 can be used to retract the blade holder 3210. This configuration advantageously allows a single user to easily cut the tab 2514 from the capsule, for example, by positioning the capsule 2512 within the trimming device 3200 and then further rotating the rotatable member 3208. Furthermore, this configuration advantageously allows the tab 2514 to be removed with a single 360 ​​degree rotation of the rotatable member 3208, which may speed up the process and avoid the need for further cutting.

[0237] 98-100 illustrate another example trimming device 3300. The trimming device 3300 may be similar to the trimming devices 3000, 3100, 3200 described above, except where otherwise indicated. That is, the trimming device 3300 may generally include a housing 3302 including a main body 3304 and a support extension member 3306 with a central recess 3305, a rotatable member 3308, and a blade holder (not shown) coupled to the rotatable member 3308, the blade holder configured to hold a blade. It should be noted that any feature described herein with respect to the trimming device 3300 may be used with the trimming devices 3000, 3100, and / or 3200, and vice versa.

[0238] The trimming device 3300 can further include a guide member 3310 coupled to the main body 3304 of the housing 3302. The guide member 3310 can include a cylindrical main body 3312 having a central longitudinally extending channel 3314. The channel 3314 can be sized to receive a first shaft of a delivery system, such as the first shaft 2504 described above.

[0239] The guide member 3310 can be coupled to the main body 3304 of the housing 3302 via an arm / retaining member 3316 which positions the guide member 3310 within a central recess 3318 of the main body 3304 and within a central recess 3320 of the rotatable member 3308. The retaining member 3316 can position the guide member 3310 within the recesses 3318, 3320 such that the guide member 3310 is suspended within the recesses 3318, 3320 and such that the guide member 3310 does not contact the main body 3304 and / or the rotatable member 3308. The distance between the guide member 3310 and the main body 3304 and / or the distance between the guide member 3310 and the rotatable member 3308 can be sized such that a wall of the capsule 2512 can be inserted between the guide member 3310 and the main body 3304 and / or between the guide member 3310 and the rotatable member 3308. The capsule 2512 can be driven forward over the guide member 3310 such that a portion of the guide member 3310 is disposed within the capsule 2512, similar to the use of the trimmer guide member 2478. The guide member 3310 can prevent or mitigate damage to internal components contained within the capsule 2512 during the cutting process.

[0240] In some examples, the guide member 3310 may include a circumferentially extending annular notch or groove 3322 (FIG. 99) similar to the groove 2490 of the trimmer guide member 2478 described above. The groove 3322 may be aligned with a cutting edge of a blade (not shown) such that the cutting edge of the blade is disposed within the groove 3322. In some examples, such as that shown in FIG. 99, the guide member 3310 may be pivotally coupled to the retaining member 3316, such as by using a pivot pin or fastener 3324. Such a configuration may allow the guide member 3310 to be movable between a use position (where the guide member is disposed within the recesses 3318, 3320) and a non-use position (see, e.g., FIG. 99).

[0241] In use, the guide member 3310 can be driven to a use position and a user can position the capsule 2512 within the trimming device 3300 such that the first shaft 2504 of the delivery device is disposed within the channel 3314 of the guide member 3310. The user can position a selected cutting location of the capsule 2512 such that the selected cutting location is aligned with the groove 3322 of the guide member 3310 and thus aligned with the cutting edge of the blade. Once aligned in this manner, the rotatable member 3308 can be rotationally driven through 360 degrees to circumferentially cut the capsule 2512 and remove the tab 2514. Positioning the blade as constrained by the groove 3322 allows the user to cut the wall of the capsule 2512 without damaging the internal components contained within the capsule. This configuration advantageously allows for a single user to easily cut the tab 2514 from the capsule, for example, by positioning the capsule 2512 within the trimming device 3300 and then rotationally driving the rotatable member 3308. Moreover, this configuration advantageously allows for the tab 2514 to be removed with a single 360 ​​degree rotation of the rotatable member 3308, which may speed up the process and avoid the need for further cutting.

[0242] 101-102, in some examples, instead of the capsule 2512 including the tab 2514, the delivery system 2500 may include a capsule 3400 that does not include a tab. In such examples, the capsule 3400 may include one or more engagement features 3402 (i.e., first engagement features) configured to engage with one or more corresponding engagement features 3406 (i.e., second engagement features) of the support tube 3404. The support tube 3404 may be similar to the support tube 2402 described above, except that the support tube 3404 includes the second engagement feature 3406.

[0243] When the capsule 3400 and support tube 3404 are assembled together, the engagement features 3402, 3406 engage to form a rigid tube structure. Such a configuration supports the flexible capsule 3400 during the loading process, thereby eliminating the need for tabs (to hold the capsule in a rigid position, as described above with respect to FIGS. 53-58). This advantageously allows a single operator to load a prosthetic valve (e.g., valve 1000, described above) into the loading assembly 2400, including the support tube 3404 instead of the support tube 2402.

[0244] Referring to FIG. 101, in some examples, the first engagement feature 3402 can include one or more protrusions 3408. In some examples, the protrusions 3408 can be formed by embedding one or more structural members within the walls of the capsule 3400. The capsule 3400 can include multiple layers (e.g., a liner, a PTFE wrap, etc.), and the structural member(s) can be sandwiched between the layers and can have a thickness such that the shape of the structural member forms a protrusion on the outer surface of the capsule 3400. For example, the structural member can be a thick wire embedded within the wall of the capsule 3400. In the illustrated example, the protrusion 3400 has a helical / spiral shape that extends around the outer periphery of the capsule, but in other examples, the protrusion(s) can have any of a variety of shapes (e.g., multiple discrete rings). In other examples, the protrusion(s) 3408 can be disposed on the outer surface of the capsule 3400, for example, as an overmolded plastic shape.

[0245] As shown in FIG. 102, the second engagement feature 3406 can be, for example, one or more recesses 3410 on the inner surface of the support tube 3404. The recess(es) 3410 can have a shape corresponding to the shape of the protrusion, for example, in the illustrated example, a helical / spiral shape. As explained above, the support tube 3404 can include a first lateral side 2403a and a second lateral side 2403b. To assemble the support tube 3404 onto the capsule 3400, the first engagement feature 3402 and the second engagement feature 3406 can be aligned with each other before the first side 2403 and the second side 2403 are secured together (e.g., using a clamp 2406). However, in other examples, the support tube 3404 can be a one-piece structure that can be driven laterally over the capsule, for example by threading the recess 3410 onto the protrusion 3408, and then twisting the support tube 3404 to drive the support tube 3404 forward over the capsule 3400.

[0246] By engaging the protrusion 3408 with the recess 3410, contact between the capsule 3400 and the loading tube 3404 is maximized, which advantageously distributes the loading force (e.g., the force applied to the capsule when loading an artificial valve) along the length of the capsule, thereby avoiding damage to the capsule material.

[0247] 103-104, in some examples, a capsule 3500 can include one or more first engagement features 3502, such as a structural member 3504 that includes one or more apertures / openings / recesses 3506 that extend into a thickness of the structural member 3504. In some examples, the apertures 3506 can extend entirely through the thickness of the structural member, such as that shown in FIG. 103. In some examples, the apertures 3506 can extend partially through the thickness, such as that shown in FIG.

[0248] In some examples, such as that shown in FIG. 103, the capsule 3500 can include multiple structural members 3504 configured as loading bands. Each loading band 3504 can be an annular / ring member embedded (e.g., sandwiched between capsule layers) within the wall 3508 of the capsule 3500. As described above, each of the loading bands 3504 can include one or more openings 3506 that extend into the thickness of the loading band. The loading bands 3504 can be configured (e.g., sized and shaped) to maintain the original outer diameter of the capsule 3500. This advantageously allows the loading bands 3504 to be added without increasing the diameter of any components that will be driven forward through the subject's vasculature. In some examples, the loading bands 3504 can include a metal (e.g., Nitinol, titanium, stainless steel, etc.) and / or a hard plastic (e.g., PEEK, polycarbonate, etc.).

[0249] In the illustrated example, the loading bands 3504 can be separate components embedded in the capsule wall 3508 such that they are spaced apart longitudinally, allowing the capsule 3500 to maintain its flexibility, which advantageously allows the capsule 3500 to be driven forward through the curvatures of the subject's vasculature. In some examples, the loading bands 3504 can have an interlocking configuration, such that when a loading force is applied during the loading process, the loading bands 3504 contact / engage / overlap with each other, advantageously distributing the loading force (e.g., the force applied to the capsule when loading a prosthetic valve) directly from one loading band to another along the length of the capsule 3500, thereby avoiding damage to the capsule material. For example, the loading band 3504 can have a stepped / chamfered / mitered edge that allows a selected portion of the loading band to be received within an adjacent portion of the loading band, such as in a shiplap or tongue and groove configuration.

[0250] In some examples, the capsule can further include a polymeric leading edge 3510 and / or a marker band 3512 disposed adjacent to the leading edge 3510. The marker band 3512 can include, for example, radiopaque markers secured to the commissures of the prosthetic heart valve to allow the commissures to be visualized under imaging (e.g., fluoroscopy) during the implantation procedure. The capsule 3500 can further include a support structure 3513, such as an embedded coil. In some examples, the support structure can be a stainless steel coil.

[0251] 104A, the support tube 3514 can include one or more second engagement features 3516 (also referred to as corresponding engagement members) configured to engage with the first engagement feature 3502. The support tube 3514 can be similar to the support tube 2402 described above. In some examples, the one or more second engagement features 3516 can include one or more protrusions / projections / nubbins 3518 extending from an inner surface 3520 of the support tube 3514. As shown in FIGS. 104A-B, the one or more protrusions 3518 of the support tube 3514 can be positioned within an opening 3506 of the structural member / loading band 3504.

[0252] In some examples, the protrusions 3518 can be integrally formed with one half of the support tube 3514, such as during molding of the support tube 3514. In other examples, the protrusions 3518 can be formed separately from the support tube 3514 and can be attached to the support tube 3514 using, for example, adhesives, welding, and / or mechanical means such as a snap fit or screws. In some examples, such as those shown in FIGS. 106A-106B, the protrusions 3518 can be integrally formed as part of an elongate member 3522 that can be attached to an inner surface 3520 of the support tube 3514. In some examples, the elongate member 3522 and the protrusions 3518 can comprise a metal (e.g., Nitinol, titanium, stainless steel, etc.) and / or a rigid plastic (e.g., PEEK, polycarbonate, etc.).

[0253] In some examples, the protrusion 3518 can have a circular cross-sectional shape (e.g., as shown in FIGS. 106A-106B), and / or a triangular cross-sectional shape (e.g., as shown in FIGS. 107A-107B), and / or a semicircular cross-sectional shape (e.g., as shown in FIG. 108). In other examples, the protrusion 3518 can have any of a variety of cross-sectional shapes, such as, for example, square, rectangular, rectilinear, oval, square oval, etc. The opening 3506 in the structural member / loading band 3504 can be configured to receive the protrusion, for example, by having a corresponding cross-sectional shape. For example, the opening 3506 in FIG. 109 can receive the protrusion 3518 shown in FIG. 108.

[0254] In some examples, such as that shown in FIG. 105, the opening 3506 in the structural member / loading band 3504 can be aligned with the opening 3524 in the outer layer(s) 3526 of the capsule wall 3508. In other examples, a thin (e.g., 0.001 mm) outer layer of the capsule 3500 can extend over the opening 3506 in the structural member / loading band 3504. In such examples, a corresponding engagement member 3516 on the support tube 3514 can deform the outer layer into the opening 3506 when placed in the opening 3506. The corresponding engagement member 3516 can be configured (e.g., sized and shaped) to deform the outer layer when inserted into the opening 3506 without perforating the outer layer.

[0255] 110-117 illustrate another example compression device 3600. The compression device 3600 can be similar to the compression device 500 described above, except that instead of or in addition to the retaining ring 544, the compression device 3600 can include one or more engagement members 3608 configured to releasably hold the first side 3604 and the second side 3606 of the housing 3602 together. In some cases, compression devices in which the first and second sides are held together by a retaining ring can tear or separate during the valve loading process, such as at the proximal / loading / inlet end of the device, which can result in damage to the valve or delivery apparatus. The compression devices disclosed herein, including the compression device 3600, include one or more engagement members configured to hold the first and second sides together, particularly at the inlet end portion of the device.

[0256] The compression device 3600 may generally include a housing 3602 including a main body 3610 (also referred to as a valve compression portion) and an extender portion 3612 (also referred to as a driver coupling portion or an actuator coupling portion), an actuator, and a pushing member removably coupled to the actuator. The pushing member may be the same as the pushing member 508 described above, and the actuator may be the same as the actuator 506 described above.

[0257] The main body 3610 of the housing 3602 may be similar to the housing 108 described above (e.g., including an inner funnel segment 3614 (FIGS. 112-113) and a number of ribs 3616), except that the main body 3610 includes or is coupled to an extender portion 3612 extending from an inlet end portion of the main body 3610. The extender portion 3612 may be a substantially cylindrical member including an inner threaded surface 3618. An inner surface of the extender portion 3612 may include a threaded portion 3618 configured to engage a threaded portion of an actuator (e.g., threaded portion 530 of actuator 506). The compression device 3600 may be used to couple a prosthetic valve to a valve retaining member of a delivery apparatus in the manner described above with respect to the compression device 500.

[0258] As discussed above, the housing 3602 includes a first side 3604 and a second side 3606 that are releasably held together via one or more engagement members 3608. Each engagement member 3608 can include a first engagement member 3620 coupled to the first side 3604 and a second engagement member 3622 coupled to the second side 3606. The first engagement member 3620 and the second engagement member 3622 can be releasably engaged with one another to prevent separation of the first side 3604 and the second side 3606, as shown in FIG.

[0259] 111-112, in some examples, the first engagement member 3620 can be a protrusion / projection / flange extending laterally from an outer surface of the first side member 3604. In some examples, as shown in FIG. 112, the first engagement member 3620 (also referred to as the flange 3620) can have a rounded sidewall 3624. With reference to FIG. 113, the second engagement member 3622 can be a member extending laterally from an outer surface of the second side member 3606. The second engagement member 3622 (also referred to as the hook-shaped member 3622) can be generally J-shaped or hook-shaped and has a first laterally extending portion 3626, a vertically extending portion 3628, and a second laterally extending portion 3630. The second engagement member 3622 can define a recess / hole / channel 3632 configured such that the first engagement member 3620 can be disposed within the channel 3632. For example, the first engagement member 3620 can be positioned so as to be aligned with the channel 3632, but axially offset from the channel along the longitudinal axis of the compression device 3600, and the first side portion 3604 can be driven axially forward such that the first engagement member 3620 slides within the channel 3632.

[0260] 110, in some examples, such as the illustrated example, the compression device 3600 can include four engagement members 3608 arranged in two pairs of two engagement members disposed diametrically opposite one another. A first pair of engagement members 3608a can be disposed adjacent an inlet end portion 3634 of the compression device 3600, and a second pair of engagement members 3608b can be disposed adjacent an outlet end portion 3636 of the compression device 3600.

[0261] 114, each of the flanges 3620b of the second pair of engaging members 3608b can include a shoulder 3638 configured to engage a locking surface 3640 (FIG. 115) of a hook-like member 3622b of the second pair of engaging members 3608b. As shown in FIGS. 115-116, the hook-like member 3622a of the first pair of engaging members 3608a and the hook-like member 3622b of the second pair of engaging members 3608b are generally similar, except that the hook-like member 3622b includes a locking surface 3640. The engagement of the shoulder 3638 with the locking surface 3640 acts as a hard stop to ensure that the first side 3604 and the second side 3606 are longitudinally aligned with one another. The shape of the hook-like member 3622 retains the flange 3620 within the channel 3632, which prevents or reduces lateral movement of the first and second sides away from one another, and the engagement of the shoulder 3638 and the locking surface 3640 prevents or reduces axial movement of the first and second sides 3604, 3606 away from one another in the first orientation, which advantageously prevents the inlet end portion 3634 of the compression device 3600 from separating during the compression process of the prosthetic valve.

[0262] FIG. 117 illustrates another example compression device 3700 that includes one or more engagement features 3708 that prevent or mitigate separation of the first and second sides 3704, 3706 of the housing 3702 from one another during the compression process of the prosthetic valve. The first side 3704 is shown in FIG. 117 as semi-transparent for illustrative purposes. The compression device 3700 can be similar to the compression device 3600, unless otherwise noted. For example, the compression device 3700 can include a retaining ring 3710 configured to encircle the sides 3704, 3706 at an outlet end portion 3712 of the device and releasably hold the sides 3704, 3706 together. The compression device 3700 can further include one or more engagement features 3708 disposed adjacent to an inlet end portion 3714 of the device 3700. In the illustrated example, the compression device 3700 includes two engagement features 3708 disposed diametrically opposite one another. However, in other examples, the device 3700 can include more or fewer engagement features 3708, which can be axially offset from one another and / or disposed at different locations along the length of the device.

[0263] The first side 3704 can include one or more recesses extending into one or more longitudinal sidewalls of the first side 3704, and the second side can include one or more protrusions 3716 extending from one or more longitudinal sidewalls of the second side 3706. The protrusions 3716 can be configured to extend into the recesses in the first side. In the illustrated example, the protrusions 3716 are cylindrical protrusions, although in other examples the protrusions can have any of a variety of shapes and the recesses can have any of a variety of corresponding shapes.

[0264] The engagement between the protrusion 3716 and the recess can prevent or mitigate lateral movement of the first side 3704 and second side 3706 away from one another, which advantageously prevents the inlet end portion 3714 of the compression device 3700 from separating during the prosthetic valve compression process.

[0265] 118A-118B illustrate another example compression device 3800 that includes one or more engagement features 3808 that prevent or mitigate separation of the first and second sides 3804, 3806 of the housing 3802 from one another during the compression process of the prosthetic valve. The compression device 3800 can be similar to the compression devices 3600, 3700, except as otherwise noted. For example, the compression device 3800 can include a retaining ring 3810 configured to encircle the sides 3804, 3806 at an outlet end portion 3812 of the device and releasably hold the sides 3804, 3806 together. The compression device 3800 can further include one or more engagement features 3808 disposed adjacent to an inlet end portion 3814 of the device 3800. In the illustrated example, the compression device 3800 includes two engagement features 3808 disposed diametrically opposite one another. However, in other examples, the device 3800 can include more or fewer engagement features 3808, which can be axially offset from one another and / or disposed at different locations along the length of the device.

[0266] 118B, the first side 3804 can include one or more first members 3816 having a hook-like engagement portion 3818, and the second side 3806 can include one or more second members 3820, each of which has a corresponding recess 3822 configured (e.g., sized and shaped) to receive the hook-like engagement portion 3818, thereby coupling the first and second members 3816, 3820. The engagement between the first and second members 3816, 3820 can prevent or mitigate the first and second sides 3804, 3806 from moving laterally away from one another. This advantageously prevents the inlet end portion 3814 of the compression device 3800 from separating during the compression process of the prosthetic valve.

[0267] In the illustrated example, the interlocking features of the first member 3816 and the second member 3820 are a hook-like engagement portion 3818 and a recess 3822, however, in other examples, the first member 3816 and the second member 3820 can have any of a variety of interlocking shapes such that the first member 3816 and the second member 3820 are configured to engage with one another and such that the first side portion 3804 and the second side portion 3806 can be held against lateral movement relative to one another.

[0268] FIG. 119 illustrates another example compression device 3900 that includes one or more engagement features 3908 that prevent or mitigate the first and second sides 3904, 3906 of the housing 3902 from separating from one another during the compression process of the prosthetic valve. The compression device 3900 can be similar to the compression devices 3600, 3700, 3800, except where otherwise noted. For example, the compression device 3900 can include a retaining ring 3910 configured to encircle the sides 3904, 3906 at an outlet end portion 3912 of the device and releasably hold the sides 3904, 3906 together. The compression device 3900 can further include one or more engagement features 3908 disposed longitudinally along the length of the device. In the illustrated example, the compression device 3900 includes two engagement features 3908 disposed diametrically opposite one another. However, in other examples, the device 3900 can include more or fewer engagement features 3908, which can be circumferentially offset from one another and / or positioned at different axial locations along the length of the device.

[0269] 119, the first side 3904 can include one or more first members 3916 extending laterally from one or more longitudinal edges of the first side. The second side 3906 can include one or more second members 3918 extending laterally from one or more longitudinal edges of the second side 3906. The first members 3916 and second members 3918 can be offset from one another along the length of the compression device 3900 such that the first members 3916 and second members 3918 are arranged in an alternating pattern. For example, as shown in FIG. 119, when the first side 3904 and second side 3906 are coupled together, each first member 3916 can be disposed between two adjacent second members 3918. The first members 3916 can frictionally engage the second members 3918 to prevent or mitigate lateral movement of the first side 3904 and second side 3906 away from one another. In some examples, the first member 3916 and the second member 3918 can include additional interlocking features. The disclosed configuration advantageously prevents the inlet end portion 3914 of the compression device 3800 from becoming separated during the compression process of the prosthetic valve.

[0270] In the illustrated example, the first member 3916 and the second member 3918 are trapezoidal projections arranged in an alternating orientation, i.e., the first member 3916 is arranged with its shorter non-sloped surface adjacent the first side 3904, and the second member 3918 is arranged with its longer non-sloped surface adjacent the second side 3906. This alternating orientation allows the first member 3916 and the second member 3918 to be coupled together as shown in FIG. 119. In other examples, the first member 3916 and the second member 3918 can have any of a variety of shapes configured to couple together along the length of the compression device 3900 and to hold the first side 3904 and the second side 3906 against lateral movement relative to one another.

[0271] Any of the described engagement features can be used in combination with one another, for example engagement feature 3708 can be used in combination with engagement feature 3908 to additionally assist in holding the inlet end portion of the compression device from separation.

[0272] 120-123, as described above, a loading assembly such as assembly 2400 can generally include a support tube 2402, a loading member / funnel member 2404, and one or more fasteners / clamps 2406, see FIGS. 53-59. In some examples, instead of or in addition to clamp 2406, loading assembly 2400 can include one or more clamps 4000. Clamp 4000 can be similar to clamp 2406 described above, except where otherwise noted. That is, the clamp 4000 can include a C-shaped main body 4002, one or more shelves 4004 ( FIG. 121 ) (e.g., two opposed shelves) extending radially inward from an inner wall of a free end portion of the clamp 4000 and along at least a portion of the length of the clamp, and one or more locking surfaces 4006 ( FIG. 121 ) extending radially inward toward a longitudinal axis of the clamp 4000. The clamp 4000 can also include alignment features 4008 (e.g., a first rib 4010 and a second rib 4010 defining a channel 4012 therebetween) and one or more tabs 4014 extending radially outward from an outer surface of the clamp 4000.

[0273] FIG. 120 illustrates an example where the clamp 4000 further includes one or more slots 4016 extending through the wall of the main body 4002 and at least partially along the length of the clamp 4000. As illustrated, in some examples, the slots 4016 have an elongated shape, a square-oval shape, or a pill shape. In other examples, the slots can be rectangular, square, triangular, non-linear (e.g., sinusoidal), etc. The slots 4016 reduce the surface area of ​​the main body 4002 that contacts the support tube 2402 and provide additional flexibility to the clamp 4000, thereby reducing the amount of force required to insert / apply and remove the clamp 4000 from the support tube 2402. In some examples, the clamp 4000 can include a flexible material, such as nylon PA12.

[0274] 121, in some examples, instead of or in addition to the slots 4016, the clamp 4000 can include one or more relief cuts / slots / recesses 4018 on the inner surface 4020 of the clamp 4000. Each recess 4018 can extend into the thickness of the inner surface and can extend at least partially along the length of the clamp. As shown, in some examples, the recesses 4018 can have a semicircular shaped cross-section, although in other examples, the relief cuts can have any of a variety of cross-sectional shapes, including square, rectangular, triangular, etc. The recesses 4018 can be located in a bending plane of the clamp 4000 such that they provide additional flexibility when compressing or pulling the clamp. This provides additional flexibility to the clamp 4000, which reduces the amount of force required to insert / apply or remove the clamp 4000 from the support tube 2402, especially when the interaction between the clamp 4000 and the support tube 2402 is a tight interference engagement.

[0275] 122-123, in some examples, instead of or in addition to the slots 4016 and / or recesses 4018, one or more clamps 4000 may include an elongated tab member configured to provide a mechanical advantage to a user during insertion or removal of the clamp 4000. FIG. 122 illustrates an example of a first clamp 4000 configured as a loader clamp 4022 (also referred to as a loader lock 4022) incorporating this feature and configured to be disposed on the first or inlet end portion 2414 of the support tube 2402, and FIG. 123 illustrates an example of a second clamp 4000 configured as a support tube clamp 4024 (also referred to as a support tube lock 4024) incorporating this feature and configured to be disposed on the second end portion 2416 of the support tube 2402.

[0276] The first clamp 4022 (e.g., a loading device lock) can include a first tab member 4026 and a second tab member 4026 extending laterally from the main body 4002 of the clamp 4000 and positioned diametrically opposite each other. As shown in FIG. 122, the tab member 4026 can have an elongated shape, for example, when compared to the tab member 4014 shown in FIGS. 120-121. The tab members 4026 can have lengths of about 0.2 inches to about 0.9 inches, about 0.3 inches to about 0.8 inches, about 0.4 inches to about 0.7 inches, and about 0.4 inches to about 0.6 inches, respectively. In some examples, the tab members can each have a length of about 0.5 inches (about 12.70 mm). The tab members 4026 can each include a curved and / or sinusoidal shape configured to form an ergonomic shape that provides a mechanical advantage to a user when applying force against the tab member 4026. The shape of the tab members 4026 can be configured to facilitate a user positioning a thumb on the tab to apply force against the loading device lock 4022.

[0277] The second clamp 4024 extends laterally from the main body 4002 of the clamp 4000 and can include diametrically opposed first and second tab members 4028 and 4028. As shown in FIG. 123, the tab member 4028 can have an elongated shape, for example, when compared to the tab member 4026 shown in FIG. The tab members 4028 can each have a length of about 0.2 inches to about 1.5 inches (about 5.08 mm to about 38.10 mm), about 0.3 inches to about 1.4 inches (about 7.62 mm to about 35.56 mm), about 0.4 inches to about 1.3 inches (about 10.16 mm to about 33.02 mm), about 0.5 inches to about 1.2 inches (about 12.70 mm to about 30.48 mm), about 1.6 inches to about 1.1 inches (about 40.64 mm to about 27.94 mm), or about 1.7 inches to about 1 inch (about 43.18 mm to about 25.40 mm). In some examples, the tab members 4028 can each have a length of about 1 inch (25.40 mm). The tab member 4028 can include a laterally extending portion 4030 and a curved or hook-like portion 4032 that extends away from the locking surface 4006. The shape of the tab member 4028 can be configured to facilitate a user positioning index and middle fingers on the tab to apply force against the support tube lock 4024.

[0278] In some examples, one or more surfaces of the tab member 4028 can include a gripping interface 4034 for easy gripping and use by a user. The gripping interface 4034 can include, for example, a plurality of spaced apart ridges and a plurality of valleys. The elongated shape of the tab member 4028 can provide a mechanical advantage to a user when applying a force against the tab member 4028. In some examples, the tab member 4028 can include a curved and / or sinusoidal shape configured to form an ergonomic shape that provides an additional mechanical advantage to a user when applying a force against the tab member 4028.

[0279] In some examples, the tab members 4026 and / or 4028 can extend from the main body 4002 of the clamp member 4000 at an angle other than 90 degrees. For example, the tab members 4026 / 4028 can extend from the main body at any angle between about 1 degree and about 179 degrees, such as, for example, between about 20 degrees and about 160 degrees, between about 45 degrees and about 135 degrees, between about 10 degrees and about 90 degrees, between about 90 degrees and about 160 degrees.

[0280] In some examples, the tab members 4026 and / or 4028 can have any of a variety of shapes. For example, FIG. 124 illustrates an example of a clamping member 4000 having a tab member 4035 that includes a laterally extending portion 4036 and a vertically extending portion 4038. As shown in FIG. 124, the vertically extending portion can be curved inwardly toward the main body 4002 of the clamping member.

[0281] Although the above examples may be described with specific reference to a loading device clamp (e.g., disposed on the inlet portion 2414) and / or a support tube clamp (e.g., disposed on the second end portion 2416 of the support tube 2402), it will be understood that any clamp member 4000 disclosed herein may be used as either a loading device clamp, a support tube clamp, or both.

[0282] 125-132 illustrate a method of using the compression device 500 shown in Figures 74-76 in combination with the loading assembly 2400 shown in Figures 53-59 to compress and load a prosthetic valve (such as the prosthetic valve 1000 shown in Figure 36) into a capsule or sheath of a delivery apparatus 2500 (Figure 57), such as capsule 2512. In other examples, the compression device 500 can be substituted for the compression device 3600 shown in Figures 110-116.

[0283] 125, the prosthetic valve 1000 can be placed on the pusher member 508 with the second anchor 1010 disposed within the seat 514 of the arm 512. The pusher member 508 can be removably coupled to the actuator 506.

[0284] As shown in FIG. 126, the prosthetic valve 1000 and pusher member 508 (and actuator 506, not shown in FIGS. 126-127 for illustrative purposes) can be positioned on a first shaft 2504 of a delivery apparatus 2500 (FIG. 57). The prosthetic valve 1000 can be oriented such that the enlarged end portion 1014 of the frame 1002 is positioned adjacent to the valve retaining member 2508. Referring to FIG. 127, the housing 502 of the compression device 500 can then be positioned on the first shaft 2504 such that it is at least partially positioned on the prosthetic valve 1000 and / or the valve retaining member 2508. The housing 502 can be positioned such that the arms 512 of the pusher member 508 (and thus the second anchor 1010 of the prosthetic valve 1000) are positioned between the ribs of the inner funnel segment 505 (FIG. 75).

[0285] As described above with respect to FIGS. 74-76, the inner surface of the housing 502 can include a threaded portion 532 (FIG. 75) configured to engage with the threaded portion 530 (FIG. 125) of the actuator 506. After the housing 502 is positioned on the first shaft 2504, the pusher member 508 can be inserted into the housing 502 until the threads 530 of the actuator 506 engage with the threads 532 (FIG. 75) of the housing. With the actuator 506 thus engaged, the pusher member 508 can be rotated and the threaded portion can translate the rotation into axial movement (e.g., pushing) of the pusher member 508, thereby driving the pusher member axially forward into the housing, thereby forcing the prosthetic valve 1000 through the housing 502. As the prosthetic valve 1000 is forced through the funnel segment 505 (FIG. 75), the prosthetic valve 1000 is radially compressed and forced toward the outlet 509. As the prosthetic valve 1000 is driven forward through the funnel segment 505, the ribs of the funnel segment 505 guide the enlarged end portion 1014 of the frame 1002 into corresponding openings in the valve retaining member 2508, as shown in FIG. 128. The combined valve retaining member 2508 and prosthetic valve 1000 can then be driven forward partially through the outlet 509.

[0286] The loading assembly 2400 can be assembled (or, in some cases, partially assembled) on the delivery apparatus 2500 prior to, concurrent with, or after the initial compression using the compression device 500. The side 2403 of the support tube 2402 can be placed onto the capsule 2512, and the first clamp 2406a can be driven forward onto the second end portion 2416 of the support tube 2402 (e.g., toward the inlet end portion 2414 of the support tube) to hold the support tube 2402 in the assembled position. The retaining member 2408 can be driven forward over the extension portion 2424 (FIG. 53) of the support tube (e.g., away from the inlet end portion 2414) to fold back the tab portion 2514 of the capsule 2512 so that the tab portion 2514 is held between the retaining member 2408 and the extension portion 2424.

[0287] The capsule 2512 can be driven forward (e.g., using the handle of the delivery apparatus 2500) until it contacts the compression device 100 (see, e.g., FIG. 61 ), and the prosthetic valve 1000 can be slowly pulled out of the compression device 100. As shown in FIG. 128 , the capsule 2512 can then be retracted (e.g., using the handle of the delivery apparatus) to ensure that the prosthetic valve 1000 is properly coupled to the valve retaining member 2508, with the actuator of the compression device held in place. As shown in FIG. 129 , in this coupled state, the outer ring 2510 can be driven forward (e.g., using the handle of the delivery apparatus) onto the valve retaining member 2508 and onto a portion of the prosthetic valve 1000 (e.g., the arm 1012 with the enlarged end portion 1014) within the valve retaining member 2508, to retain the enlarged end portion 1014 within the valve retaining member 2508 when the compression device 500 is removed from the first shaft 2504.

[0288] 130, the loading assembly 2400 can then be driven forward onto the outer ring 2510. In some instances, such as that shown in FIG. 62, the guidewire shield 2506 can be driven forward (e.g., using an advancement tool 2516) distally over the first shaft 2504 to protect the first shaft 2504 during the remainder of the loading process. As shown in FIG. 131, the capsule 2512 (and thus the attached loading assembly 2400) can be driven forward onto the prosthetic valve 1000 using the handle of the delivery device 2500 (or the prosthetic valve 1000 can be retracted into the assembled capsule and loading assembly). As seen in FIG. 131, when the loading assembly 2400 is driven forward onto the prosthetic valve 1000, the funnel portion 2404 radially compresses the prosthetic valve 1000, thereby loading the prosthetic valve into the capsule 2512 (within the support tube 2402). More specifically, as the capsule 2512 and loading assembly 2400 are driven forward onto the prosthetic valve 1000, the anchors 1010 of the prosthetic valve 1000 may contact and be inverted by the funnel member 2404, causing the prosthetic valve 1000 to transition from an unconstrained configuration to a substantially straight configuration in which the anchors 1010 extend distally from the main body 1003 and are rotated approximately 180 degrees.

[0289] With the tab members 2514 (see, e.g., FIG. 57 ) of the capsule 2512 folded proximally onto the capsule 2512 and held in place by the retaining members 2408, the distal end portion of the capsule 2512 can be kept taut as the prosthetic valve 1000 is inserted into the capsule. This can prevent the capsule from bunching or buckling during the loading process. The support tube 2402 can also provide additional structural support to the capsule 2512. In certain examples, the funnel member 2404 of the loading assembly 2400 can be filled with saline (e.g., provided from a port in the handle of the delivery device) when loading the prosthetic valve. In certain examples, the free apex of the prosthetic valve frame can be guided into the funnel portion 2458 using, for example, the tool 1516 ( FIG. 62 ).

[0290] 132, after the prosthetic valve 1000 is fully received within the capsule 2512, the loading assembly 2400 can be removed from the delivery device 2500 (e.g., by removing the first clamp 2406 and the second clamp 2406, as well as removing the side 2460 of the funnel member 2404 and the side 2403 of the support tube 2402). After the prosthetic valve is fully loaded into the capsule 2512, the tab 2514 can be removed from the capsule 2512 using any tab cutting method or device described herein (e.g., using the tab trimming device 3000). With the tab 2514 thus removed, the nose cone 2502 (FIG. 130) can be retracted proximally toward the capsule 2512 until the proximal edge of the nose cone 2502 abuts against the distal edge of the capsule.

[0291] Any of the systems, devices, apparatus, etc. herein may be sterilized (e.g., using heat / high temperature, pressure, steam, radiation, and / or chemicals, etc.) to ensure that they are safe for use on patients, and any of the methods herein may include sterilizing the associated system, device, apparatus, etc. as one of the various steps in the method. Examples of heat / high temperature sterilization include steam sterilization and autoclave sterilization. Examples of radiation for use in sterilization include, but are not limited to, gamma radiation, ultraviolet light, and electron beam. Examples of chemicals for use in sterilization include, but are not limited to, ethylene oxide, hydrogen peroxide, peracetic acid, formaldehyde, and glutaraldehyde. Hydrogen peroxide sterilization may be performed, for example, using hydrogen peroxide plasma.

[0292] Additional Examples of the Disclosed Technology In view of the above implementations of the disclosed subject matter, the present application discloses additional examples, which are listed below. It should be noted that a feature in an example individually, or two or more features in combination in that example, and optionally in combination with one or more features in one or more additional examples, are also further examples falling within the disclosure of the present application.

[0293] Example 1. 1. A compression device comprising: a housing configured to receive a radially expandable and compressible prosthetic valve in a radially expanded state, the housing including a funnel segment extending at least partially along an axial length of the housing and an outlet in communication with the funnel segment; a pusher member having an outer diameter smaller than an inner diameter of the housing such that it can be driven forward into the housing; and an actuator removably coupled to the pushing member, wherein manually driving the actuator axially forward relative to the housing drives the artificial valve axially through the funnel segment, whereby at least a portion of the artificial valve is radially compressed by engagement with the funnel segment and expelled from the compression device via the outlet.

[0294] Example 2. The compression device as described in any embodiment herein, particularly as described in embodiment 1, wherein the funnel segment includes a plurality of ribs spaced about an inner periphery of the housing and extending radially inwardly.

[0295] Example 3. The compression device as described in any embodiment herein, particularly as described in embodiment 2, wherein the ribs extend radially inward toward the longitudinal axis of the housing.

[0296] Example 4. The compression device as described in any embodiment herein, particularly embodiment 2 or 3, wherein the ribs radially increase in thickness from a first thickness adjacent the inlet end portion of the housing to a second thickness adjacent the outlet, the second thickness being thicker than the first thickness.

[0297] Example 5. The compression device of any embodiment herein, particularly any one of embodiments 2-4, wherein the rib comprises a first tapered portion disposed at a first angle and a second tapered portion disposed at a second angle.

[0298] Example 6. The compression device as described in any embodiment herein, particularly embodiment 5, wherein the first angle is less than the second angle.

[0299] Example 7. The compression device as described in any embodiment herein, particularly as described in embodiment 5 or 6, wherein the first tapered portion and the second tapered portion are configured to compress the prosthetic valve at different rates.

[0300] Example 8. The compression device according to any embodiment herein, particularly any one of embodiments 1-7, wherein the housing comprises two or more separable portions, each separable portion comprising a portion of a funnel segment.

[0301] Example 9. The compression device as described in any embodiment herein, particularly as described in embodiment 8, further comprising a retaining member configured to releasably hold two or more separable portions together.

[0302] Example 10. The compression device according to any embodiment herein, particularly any one of embodiments 1-9, wherein the pushing member comprises a plurality of circumferentially spaced apart and radially extending arms.

[0303] Example 11. The compression device as described in any embodiment herein, particularly embodiment 10, wherein the arms are configured to be movably positioned between the ribs of the funnel segment.

[0304] Example 12. A compression device as described in any embodiment herein, particularly embodiment 10 or 11, wherein each arm includes a retaining portion having a first wall and a second wall, and a channel is defined between the first wall and the second wall.

[0305] Example 13. The compression device according to any embodiment herein, particularly any one of embodiments 1-12, wherein the pushing member comprises a first end portion having a first diameter and a second end portion having a second diameter smaller than the first diameter.

[0306] Example 14. A compression device as described in any embodiment herein, particularly embodiment 13, wherein the second end portion includes one or more releasable locking features configured to engage with one or more corresponding locking features on the actuator.

[0307] Example 15. The compression device as described in any embodiment herein, particularly embodiment 14, wherein the one or more locking features comprises a resilient latch.

[0308] Example 16. The compression device as described in any embodiment herein, particularly embodiment 14 or 15, wherein the locking feature of the actuator comprises an aperture.

[0309] Example 17. The compression device according to any embodiment herein, particularly any one of embodiments 1-16, wherein the actuator includes a base and one or more extension members extending from the base.

[0310] Example 18. A compression device as described in any embodiment herein, particularly embodiment 17, wherein the one or more extension members are configured to maintain angular alignment between the actuator and the housing during compression of the artificial valve.

[0311] Example 19. The compression device as described in any embodiment herein, particularly embodiment 17 or 18, wherein the one or more extension members include a central extension member having an inner hole and one or more linear guide members.

[0312] Example 20. A compression device as described in any embodiment herein, particularly embodiment 19, wherein the one or more linear guide members include an elongated member tapered from a first thickness adjacent a radially outer edge of the actuator to a second thickness adjacent a central extension member.

[0313] Example 21. A compression device as described in any embodiment herein, particularly as described in embodiment 19 or 20, wherein the one or more linear guide members are configured to be movably positioned between one or more ribs of the funnel segment.

[0314] Example 22. The compression device according to any embodiment herein, particularly any one of embodiments 1-17, wherein the one or more extension members include a first cylindrical extension member defining an inner bore and a second cylindrical extension member disposed about a radially outer periphery of the base.

[0315] Example 23. The compression device as described in any embodiment herein, particularly embodiment 22, wherein the first cylindrical extension member has a first height and the second cylindrical extension member has a second height, the first height being less than the second height.

[0316] Example 24. A compression device as described in any embodiment herein, particularly any one of embodiments 1 to 23, wherein the actuator further includes an engagement mechanism configured to releasably engage with a corresponding engagement mechanism on the housing, thereby locking the actuator and housing together after the artificial valve has been driven at least partially forward through the outlet.

[0317] Example 25. The compression device according to any embodiment herein, particularly any one of embodiments 1 to 24, wherein the pushing member and the actuator each comprise an inner bore configured to receive a shaft of the delivery device.

[0318] Example 26. The compression device according to any embodiment herein, particularly any one of embodiments 1-25, wherein the actuator and the housing are configured to be axially pressed together.

[0319] Example 27. 1. A compression device comprising: a housing configured to receive a radially expandable and compressible prosthetic valve in a radially expanded state; a funnel segment extending at least partially along an axial length of the housing, the funnel segment including a plurality of ribs spaced about a periphery of the housing and extending inwardly toward the longitudinal axis of the housing; an outlet in communication with the funnel segment; and a pusher member configured to abut against the prosthetic valve within the housing when the prosthetic valve is received within the housing; a stem having a first end portion and a second end portion including one or more resilient latches; a pusher member including a plurality of arms extending from a first end portion, each arm including a seat configured to engage an adjacent end portion of the prosthetic valve; an actuator releasably coupled to the pusher member via one or more apertures engaged with one or more resilient latches; A compression device in which the actuator is manually driven axially forward relative to the housing, thereby driving the artificial valve axially through the funnel segment, whereby at least a portion of the artificial valve is radially compressed by engagement with the funnel segment and expelled from the compression device via the outlet.

[0320] Example 28. A compression device as described in any embodiment herein, particularly embodiment 27, wherein the rib increases in thickness along its length from a first thickness adjacent the inlet end portion of the housing to a second thickness adjacent the outlet, the second thickness being thicker than the first thickness.

[0321] Example 29. The compression device as described in any embodiment herein, particularly embodiment 27 or 28, wherein the housing comprises two or more sides, each side comprising a portion of a funnel segment.

[0322] Example 30. The compression device as described in any embodiment herein, particularly embodiment 29, further comprising a retaining member configured to releasably hold two or more sides together.

[0323] Example 31. The compression device according to any embodiment herein, particularly any one of embodiments 27-30, wherein the arms extend radially from the pushing member.

[0324] Example 32. The compression device as described in any embodiment herein, particularly embodiment 31, wherein the arms are configured to be movably positioned between the ribs of the funnel segment.

[0325] Example 33. The compression device as described in any embodiment herein, particularly embodiment 31 or 32, wherein the seat of each arm includes a first wall and a second wall, and a channel is defined between the first wall and the second wall.

[0326] Example 34. The compression device as described in any embodiment herein, particularly any one of embodiments 27-33, wherein the pushing member includes a first end portion having a first diameter and a second end portion having a second diameter smaller than the first diameter.

[0327] Example 35. A compression device as described in any embodiment herein, particularly embodiment 34, wherein the second end portion includes one or more removable locking features configured to engage with one or more corresponding locking features on the actuator.

[0328] Example 36. The compression device described in any embodiment herein, particularly any one of embodiments 27 to 35, wherein the actuator includes a base, a central extension member having an inner hole, and one or more linear guide members.

[0329] Example 37. A compression device as described in any embodiment herein, particularly embodiment 36, wherein the one or more linear guide members include an elongated member tapered from a first thickness adjacent a radially outer edge of the actuator to a second thickness adjacent a central extension member.

[0330] Example 38. A compression device as described in any embodiment herein, particularly embodiment 37, wherein the one or more linear guide members are configured to be movably positioned between one or more ribs of the funnel segment.

[0331] Example 39. A compression device as described in any embodiment herein, particularly any one of embodiments 27 to 38, wherein the actuator further includes an engagement mechanism configured to releasably engage with a corresponding engagement mechanism on the housing, thereby locking the actuator and housing together after the artificial valve has been driven at least partially forward through the outlet.

[0332] Example 40. The compression device according to any embodiment herein, particularly any one of embodiments 27 to 39, wherein the pushing member and the actuator each comprise an inner bore configured to receive a shaft of the delivery device.

[0333] 41. 1. An assembly comprising: A compression device, a housing including an inner bore having a funnel segment extending at least partially along an axial length of the housing and an outlet in communication with the funnel segment, the funnel segment including a plurality of spaced radially inwardly extending ribs disposed about an inner periphery of the funnel segment; a pusher member including a plurality of circumferentially spaced radially extending arms configured to be movably positioned between the ribs of the funnel segment; a compression device including: an actuator removably coupled to the pushing member, the actuator and the pushing member configured to be axially movable relative to the housing; a radially expandable and compressible prosthetic valve disposed within a funnel segment, the prosthetic valve including a frame, a valve structure disposed within the frame, and a plurality of connecting arms extending from the frame, the plurality of connecting arms including enlarged end portions; The assembly is configured such that by manually driving the actuator and pushing member axially forward relative to the housing, the artificial valve is driven axially through the funnel segment, whereby at least a portion of the artificial valve is radially compressed by engagement with the funnel segment and expelled from the compression device via the outlet.

[0334] Example 42. An assembly as described in any embodiment herein, particularly embodiment 41, wherein the pushing member has an outer diameter smaller than the inner diameter of the housing, thereby being capable of being driven into and out of the housing.

[0335] Example 43. An assembly as described in any embodiment herein, particularly embodiment 41 or 42, wherein each arm of the pushing member includes a retaining portion having a first wall and a second wall, a channel being defined between the first wall and the second wall, and the artificial valve includes a plurality of anchors configured to be positioned within the corresponding channels.

[0336] Example 44. The assembly according to any of the embodiments herein, particularly any one of embodiments 41 to 43, wherein the frame of the artificial valve is a self-expandable frame.

[0337] Example 45. 1. An assembly comprising: a delivery device including a shaft and a valve retaining member coupled to a distal end portion of the shaft, the valve retaining member including a plurality of circumferentially spaced slots; a compression device disposed on the shaft; a housing defining an inner bore having a funnel segment extending at least partially along an axial length of the housing and an outlet in communication with the funnel segment, the funnel segment including a plurality of ribs spaced about an inner periphery of the funnel segment and extending radially inward; a pusher member including a plurality of circumferentially spaced radially extending arms configured to be movably positioned between the ribs of the funnel segment; a compression device including: an actuator removably coupled to the pushing member, the actuator and the pushing member configured to be axially movable relative to the housing; a radially expandable and compressible prosthetic valve disposed within a funnel segment, the prosthetic valve including a frame, a valve structure disposed within the frame, and a plurality of connecting arms extending from the frame, the plurality of connecting arms including enlarged end portions; Manually driving the actuator and the pusher member axially forward relative to the housing drives the prosthetic valve axially through the funnel segment, whereby at least a portion of the prosthetic valve is radially compressed by engagement with the funnel segment and expelled from the compression device via the outlet; The assembly, wherein the enlarged end portions of the connecting arms are configured to extend into circumferentially spaced slots in the valve retaining member to restrain the artificial valve against movement relative to the valve retaining member.

[0338] Example 46. 1. A method for compressing a prosthetic valve, comprising: inserting the prosthetic valve in a radially expanded state into an inlet end portion of a compression device, the compression device including a housing defining a funnel segment extending at least partially along an axial length of the housing and an outlet in communication with the funnel segment; aligning a pusher member removably coupled to the actuator with a first end portion of the prosthetic valve adjacent the inlet end portion; applying an axial force to the actuator to drive the actuator and the pusher member forward into the housing, thereby driving the prosthetic valve forward through the funnel segment, thereby radially compressing the prosthetic valve.

[0339] Example 47. The method of any embodiment herein, particularly embodiment 46, further comprising driving the prosthetic valve forward through an outlet in the outlet end portion of the housing.

[0340] Example 48. the compression device is disposed on a first shaft of a delivery apparatus, the delivery apparatus further comprising a valve retaining member coupled to a distal end portion of the shaft;

[0341] A method as described in any embodiment herein, particularly embodiment 47, wherein driving the artificial valve forward through the outlet includes driving a plurality of connecting arms extending from the artificial valve forward into a plurality of circumferentially spaced slots in the valve retaining member.

[0342] Example 49. The method of any embodiment herein, particularly any one of embodiments 46-48, wherein aligning the pushing member with respect to the first end portion of the artificial valve includes placing a plurality of anchors extending from the artificial valve into a plurality of channels defined in the pushing member.

[0343] Example 50. 1. A compression device comprising: a housing configured to receive a radially expandable and compressible prosthetic valve in a radially expanded state, the housing including a funnel segment extending at least partially along an axial length of the housing and an outlet in communication with the funnel segment; a pusher member configured to abut against the artificial valve inside the housing, the pusher member having an outer diameter smaller than an inner diameter of the housing so that the pusher member can be driven forward into the housing; an actuator removably coupled to the pusher member, the actuator including a base member and one or more elongate guide members extending from the base member, each elongate guide member including a slot extending at least partially along a length of the guide member and a slidable member slidably disposed within the slot, the slidable member being removably coupled to the housing; A compression device in which the housing is axially driven forward relative to the base member, causing the slidable members to slide within their corresponding slots, thereby inserting the pushing member into the housing to drive the artificial valve axially through the funnel segments, whereby at least a portion of the artificial valve is radially compressed by engagement with the funnel segments and expelled from the compression device through the outlet.

[0344] Example 51. The compression device as described in any embodiment herein, particularly embodiment 50, wherein the elongated guides are spaced apart around the periphery of the base member.

[0345] Example 52. A compression device as described in any embodiment herein, particularly embodiment 50 or 51, wherein the elongated guide includes a first end portion and a second end portion, the second end portion including a bracket configured to be removably coupled to the base member.

[0346] Example 53. A compression device as described in any embodiment herein, particularly any one of embodiments 50 to 52, wherein each slidable member includes a main portion and a protrusion, the protrusions being positioned within corresponding slots to slidably couple the slidable members to the elongate guide.

[0347] Example 54. A compression device as described in any embodiment herein, particularly embodiment 53, wherein the slidable member includes an opening configured to receive a fastening member for releasably coupling the slidable member to the housing.

[0348] Example 55. 1. An assembly comprising: A compression device, a housing configured to receive a radially expandable and compressible prosthetic valve in a radially expanded state, the housing including a funnel segment extending at least partially along an axial length of the housing and an outlet in communication with the funnel segment; a pusher member configured to abut against the artificial valve inside the housing, the pusher member having an outer diameter smaller than an inner diameter of the housing so that the pusher member can be driven forward into the housing; a compression device including: an actuator removably coupled to the pusher member, the actuator including a base member and one or more elongate guides extending from the base member, each elongate guide including a slot extending at least partially along a length of the guide, and a slidable member slidably disposed within the slot, the slidable member being removably coupled to the housing; and a radially expandable and compressible prosthetic valve disposed within a funnel segment, the prosthetic valve including a frame, a valve structure disposed within the frame, and a plurality of connecting arms extending from the frame, the plurality of connecting arms including enlarged end portions; The assembly comprises a housing, the housing being axially driven forward relative to the base member, such that the slidable members are slidably driven within their corresponding slots, whereby the pushing member is inserted into the housing, driving the artificial valve axially through the funnel segments, whereby at least a portion of the artificial valve is radially compressed by engagement with the funnel segments and expelled from the compression device via the outlet.

[0349] Example 56. An assembly as described in any embodiment herein, particularly embodiment 55, wherein each arm of the pushing member includes a seat having a first wall and a second wall, a channel being defined between the first wall and the second wall, and the artificial valve includes a plurality of anchors configured to be positioned within the corresponding channels.

[0350] Example 57. 1. An assembly comprising: a delivery device including a shaft and a valve retaining member coupled to a distal end portion of the shaft, the valve retaining member including a plurality of circumferentially spaced slots; a compression device disposed on the shaft; a housing configured to receive a radially expandable and compressible prosthetic valve in a radially expanded state, the housing including a funnel segment extending at least partially along an axial length of the housing and an outlet in communication with the funnel segment; a pusher member configured to abut against the artificial valve inside the housing, the pusher member having an outer diameter smaller than an inner diameter of the housing so that the pusher member can be driven forward into the housing; a compression device including: an actuator removably coupled to the pusher member, the actuator including a base member and one or more elongate guides extending from the base member, each elongate guide including a slot extending at least partially along a length of the guide, and a slidable member slidably disposed within the slot, the slidable member being removably coupled to the housing; and a radially expandable and compressible prosthetic valve disposed within a funnel segment, the prosthetic valve including a frame, a valve structure disposed within the frame, and a plurality of connecting arms extending from the frame, the plurality of connecting arms including enlarged end portions; The housing is axially driven forward relative to the base member to slidably drive the slidable members within the corresponding slots, thereby driving the prosthetic valve axially through the funnel segments by inserting the pusher member into the housing, whereby at least a portion of the prosthetic valve is radially compressed by engagement with the funnel segments and expelled from the compression device via the outlet; The assembly, wherein the enlarged end portions of the connecting arms are configured to extend into circumferentially spaced slots in the valve retaining member to restrain the artificial valve against movement relative to the valve retaining member.

[0351] 58. 1. A method for compressing a prosthetic valve, comprising: inserting the prosthetic valve in a radially expanded state into an inlet end portion of a housing of a compression device, the housing defining a funnel segment extending at least partially along an axial length of the housing and an outlet in communication with the funnel segment; coupling one or more slidable members of an actuator to the housing, the actuator including a plurality of slidable members disposed within slots in an elongated guide extending from a base member of the actuator; and driving the actuator and housing forward together, such that a pushing member coupled to a base member of the actuator drives the prosthetic valve forward further into the housing and through the funnel segment, thereby radially compressing the prosthetic valve.

[0352] Example 59. The method of any embodiment herein, particularly embodiment 58, wherein driving the pushing member forward into the housing includes applying an axial force to the housing to slide the housing along the ...

Claims

1. A system for loading a delivery device, comprising: a housing sized to receive a radially expanded prosthetic heart valve, the housing including a funnel segment extending at least partially along an axial length of the housing and an outlet in communication with the funnel segment; an actuator configured to assist in moving the prosthetic heart valve at least partially through the funnel segment and at least partially out of the outlet; a loading assembly including a support tube positionable over a capsule of the delivery device and a funnel member positionable over a first portion of the support tube and over at least a portion of the prosthetic valve; the loading assembly is configured such that axial advancement of the funnel member over the prosthetic valve or retraction of the prosthetic valve through the funnel member radially compresses the prosthetic valve by engagement with the funnel member.

2. The system described in claim 1, wherein the housing includes an extender portion having a first threaded surface, and the actuator includes a second threaded surface configured to engage with the first threaded surface of the extender portion.

3. The system of claim 1, further comprising a pushing member coupled to the actuator, the actuator configured to cause axial advancement of the pushing member such that the pushing member advances the prosthetic heart valve through the funnel segment and at least partially out of the outlet.

4. The system described in claim 1, further comprising a first clamp member that can be positioned on a portion of the funnel member, and a second clamp member that can be positioned on a second end of the support tube.

5. The system described in claim 1, wherein the support tube has a first portion and a second portion, and the first portion and the second portion are held together by the first clamping member and the second clamping member.

6. The system described in claim 4, wherein the first clamping member and the second clamping member each have a first rib and a second rib extending from an inner surface, the first rib and the second rib defining a channel between the first rib and the second rib.

7. The system described in claim 1, wherein the first clamping member and the second clamping member each have a main body, the first clamping member and the second clamping member each have one or more first tab members extending laterally from the main body, the first tab members having a sinusoidal shape, and the second clamping member has one or more second tab members extending laterally from the main body, the second tab members having a length greater than a length of the first tab members.

8. The system described in claim 1, wherein the loading assembly further comprises a ring configured to hold a portion of the capsule of the delivery device between the inner surface of the ring and the outer surface of the support tube.

9. A system usable to couple a medical device and a delivery apparatus, wherein the medical device is radially expandable and compressible, the system comprising:

1. A compression device comprising: a housing having an inlet sized to receive the medical device in a radially expanded state, the housing comprising a funnel segment extending at least partially along an axial length of the housing, and an outlet in communication with the funnel segment; an actuator configured to engage a pusher member, wherein rotation of the actuator advances the pusher member axially to move the medical device along the funnel segment of the housing, at least partially compressing the medical device and advancing at least a portion of the medical device out of the outlet, thereby allowing the medical device to couple with the delivery apparatus; and a compression device comprising: a support tube having a first portion and a second portion positionable around the capsule of the delivery device, the support tube comprising a proximal end portion and a distal end portion; a funnel member removably coupleable to the distal end portion of the support tube, the funnel member configured to radially compress and guide the medical device into the capsule when the funnel member is advanced over the medical device or when the medical device is retracted through the funnel member; A system comprising:

10. The system described in claim 9, wherein the compression device is configured to at least partially compress the medical device and move the medical device along the funnel segment of the housing to advance at least a portion of the medical device out of the outlet, the medical device is coupled to the delivery device, and the compression device can be removed from around the medical device before the funnel member is used separately to radially compress and guide the medical device into the capsule.

11. The system of claim 9, further comprising a first clamping member and a second clamping member, the first clamping member including a first alignment feature configured to engage with a corresponding alignment feature on a proximal end portion of the support tube, the first clamping member further including two opposing first tabs extending from an outer surface of the first clamping member, the first tabs each having a laterally extending portion.

12. The system described in claim 11, wherein the second clamping member includes a second alignment feature configured to engage with a corresponding alignment feature of the funnel member, and the second clamping member further includes two opposing second tabs, each of the second tabs having a sinusoidal shape.

13. The system described in claim 12, wherein the funnel member has a first flange and a second flange extending from an outer surface of the funnel member, and the second clamping member has a locking surface configured to engage with the first flange and the second flange of the funnel member to prevent the second clamping member from advancing beyond a selected location.

14. A system usable for loading a medical device into a capsule of a delivery device, the system comprising:

1. A loading assembly comprising: a support tube configured to be positioned over the capsule of the delivery device; a funnel member positionable over a portion of the support tube and positionable over at least a portion of the medical device; The system includes a loading assembly configured such that axial advancement of the funnel member on the medical device or retraction of the medical device through the funnel member radially compresses the medical device as the medical device is moved into the capsule.

15. The system described in claim 1, further comprising a first clamp member that can be positioned on a portion of the funnel member, and a second clamp member that can be positioned on a second end of the support tube.

15. The system of claim 14.

16. The outer surface of the first end of the support tube is:

15. The system of claim 14, wherein the support tube includes one or more recesses extending inward toward a central axis thereof, and the funnel member includes an annular shoulder disposed within the one or more recesses when the loading assembly is in an assembled configuration.

17. The method of claim 1, further comprising: a housing having an inlet sized to receive the medical device in a radially expanded state, the housing comprising a funnel segment extending at least partially along an axial length of the housing, and an outlet in communication with the funnel segment; an actuator configured to assist in moving the medical device along the funnel segment of the housing, the actuator at least partially compressing the medical device and advancing at least a portion of the medical device out of the outlet so that the medical device can be coupled with the delivery apparatus; and The system of claim 14, comprising:

18. The system described in claim 17, wherein the actuator is configured to engage with a pushing member of the compression device, such that rotation of the actuator advances the pushing member axially to move the medical device along the funnel segment of the housing, at least partially compressing the medical device and advancing at least a portion of the medical device out of the outlet, facilitating coupling of the medical device with the delivery apparatus.

19. A delivery device comprising a shaft carrying a capsule; 1. A compression device comprising: a compression device including a housing and an actuator configured to advance a radially expanded medical device within a funnel segment of the housing to assist in compressing the medical device; a loading assembly; a support tube having a first portion and a second portion configured to be assembled over the capsule of the delivery device; a funnel member configured to be assembled with the support tube and configured to be disposable over at least a portion of the medical device, the funnel member comprising a first funnel member portion and a second funnel member portion, the assembled funnel member comprising an inlet end having a first diameter and an outlet end having a second, smaller diameter; the loading assembly is configured such that axial advancement of the inlet end of the funnel member onto the medical device or retraction of the medical device within the funnel member from the inlet end toward the outlet end radially compresses the medical device as the medical device enters the capsule.

20. A system usable to couple a medical device and a delivery apparatus, wherein the medical device is radially expandable and compressible, the system comprising:

1. A compression device comprising: a housing having an inlet sized to receive the medical device in a radially expanded state, the housing comprising a funnel segment extending at least partially along an axial length of the housing, and an outlet in communication with the funnel segment; a compression device comprising: an actuator configured to engage a pusher member, wherein rotation of the actuator axially advances the pusher member to move the medical device along the funnel segment of the housing, at least partially compressing the medical device and advancing at least a portion of the medical device out of the outlet, thereby allowing the medical device to be coupled with the delivery apparatus; a support tube having a first portion and a second portion positionable around the capsule of the delivery device, the support tube comprising a proximal end portion and a distal end portion; a first clamp member and a second clamp member, the first clamp member including a first alignment feature configured to engage a corresponding alignment feature on a proximal end portion of the support tube, the first clamp member further including two opposing first tabs extending from an outer surface of the first clamp member, the first tabs each including a laterally extending portion; A system comprising:

Images