System and method for crimping and device preparation

Abstract

To provide an improved apparatus, system and method for use in crimping and other device preparation.SOLUTION: Apparatuses, systems, and methods for crimping an implant and for device preparation. The apparatus in certain embodiments may include a crimping device for compressing the implant prior to deployment into a portion of a patient's body. The support may be utilized to reduce the likelihood of damage to the implant during the crimping process. Other objects may be utilized to improve the accuracy of the crimped position of the implant on the delivery device.SELECTED DRAWING: Figure 6

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Provisional Application No. 63 / 072,444, filed August 31, 2020, U.S. Provisional Application No. 63 / 137,658, filed January 14, 2021, and U.S. Provisional Application No. 63 / 220,024, filed July 9, 2021, the entire contents of each of which are incorporated herein by reference.

[0002] Certain embodiments disclosed herein may relate to devices, systems, and methods for crimping an implant. In certain embodiments, the systems may be for use in crimping prosthetic implants. Certain embodiments disclosed herein may relate to devices, systems, and methods for device preparation. [Background technology]

[0003] Human heart valves, including the aortic, pulmonary, mitral, and tricuspid valves, essentially function as one-way valves that operate in sync with the heartbeat. The valves allow blood to flow downstream but block blood from flowing upstream. Affected heart valves exhibit defects such as valve stenosis or regurgitation, impairing the valve's ability to control blood flow. Such defects reduce the heart's blood-pumping efficiency and can lead to debilitating and life-threatening conditions. For example, valve malfunction can lead to conditions such as cardiac hypertrophy and ventricular dilation. Consequently, extensive efforts have been made to develop methods and devices for repairing or replacing defective heart valves.

[0004] Prostheses exist to correct problems associated with heart valve failure. For example, mechanical and tissue-based heart valve prostheses can be used to replace a failed natural heart valve. In recent years, considerable effort has been devoted to developing replacement heart valves, particularly tissue-based replacement heart valves, which can be delivered with less trauma to the patient than open-heart surgery. Replacement valves are designed to be delivered through minimally invasive procedures, even percutaneous procedures. Such replacement valves often include a tissue-based valve body connected to an expandable frame and then delivered to the annulus of the natural valve.

[0005] The development of prostheses, including but not limited to replacement heart valves, that can be miniaturized for delivery and then controllably expanded for controlled placement has proven particularly challenging. A delivery device may be provided for deploying such implants at a desired location within the human body. The implant may be in a compressed state when coupled to the delivery device and must therefore be compressed for delivery to the desired location of implantation within the patient's body.

[0006] Such implants may be self-expandable, balloon-expandable, or mechanically expandable. Balloon-expandable prosthetic valves are typically crimped from an initial large diameter to a smaller diameter before advancement to a treatment site within the body. Prior to crimping, balloon-expandable prosthetic valves are typically placed over an inflatable balloon on a catheter shaft. Once delivered to the implantation site, the balloon may be inflated to expand the prosthetic valve to its functional size. Self-expanding prosthetic implants are also typically crimped to a smaller diameter, but are then inserted into a sheath. After placement within the body, the sheath is retracted, allowing the prosthetic valve to expand within the body. Mechanically expandable prosthetic implants may also be crimped to a smaller diameter. Summary of the Invention [Problem to be solved by the invention]

[0007] Although methods exist for crimping such implants prior to delivery, it may be desirable to provide improved apparatus, systems, and methods for use in crimping and other device preparation. [Means for solving the problem]

[0008] Embodiments of the present disclosure may be directed to devices, systems, and methods for use in crimping an implant, as well as other devices, systems, and methods for device preparation. The devices, systems, and methods disclosed herein may be directed to more accurately positioning an implant on a delivery device and more effectively crimping the implant to the delivery device. Certain features disclosed herein may be directed to improving the function of the implant after deployment, including a reduced likelihood of damage to the implant during the crimping process. Other features may be directed to improved ways of bending or otherwise positioning the elongate shaft of a delivery device during a crimping procedure or another device preparation procedure.

[0009] One or more embodiments of the present disclosure include a system for use in crimping a prosthetic implant having one or more valve leaflets onto a delivery apparatus. The system may include a support configured to be inserted into the crimping device, positioned between the one or more valve leaflets and the delivery apparatus, and having a support surface configured to support the one or more valve leaflets in an open position.

[0010] One or more embodiments of the present disclosure include a system for use in crimping a prosthetic implant having one or more valve leaflets onto a delivery device. The system may include a ring body including one or more indicators that indicate the rotational position of the prosthetic implant relative to the ring body.

[0011] One or more embodiments of the present disclosure include a method that may include positioning a delivery apparatus within a channel of a crimping device that includes one or more pressing surfaces configured to radially compress a prosthetic implant within the channel.

[0012] The method may include positioning a prosthetic implant within the channel and around the delivery device, the prosthetic implant including one or more valve leaflets. The method may include positioning a support within the channel and between the one or more valve leaflets and the delivery device.

[0013] The method can include supporting one or more leaflets in an open position with a support. The method can include crimping the prosthetic implant onto the delivery apparatus utilizing one or more pressing surfaces of a crimping device.

[0014] One or more embodiments of the present disclosure include a system for use in crimping a prosthetic implant having one or more valve leaflets onto a delivery apparatus, the system may include a stopper housing including a cavity configured to receive a portion of the delivery apparatus distal to an implant retention area of ​​the delivery apparatus, the stopper housing including a contact surface configured to abut the delivery apparatus to prevent axial distal movement of the delivery apparatus when the delivery apparatus is positioned within a crimping device configured to crimp the prosthetic implant onto the delivery apparatus.

[0015] One or more embodiments of the present disclosure include a method. The method may include positioning a delivery apparatus within a channel of a crimping device including one or more pressing surfaces configured to radially compress the prosthetic implant within the channel. The method may include positioning the prosthetic implant within the channel and around the delivery apparatus.

[0016] The method can include abutting a stopper housing at a location of the delivery device distal to an implant holding area of ​​the delivery device to define a location of the delivery device within a channel of the crimping device. The method can include utilizing one or more pressing surfaces of the crimping device to crimp the prosthetic implant onto the delivery device.

[0017] One or more embodiments of the present disclosure include a system for use in crimping a prosthetic implant having one or more valve leaflets onto a delivery device. The system may include a spacer body configured to extend over a portion of the delivery device distal to an implant holding area of ​​the delivery device and including a contact surface for abutting a distal end of the prosthetic implant to define a position of the prosthetic implant on the delivery device.

[0018] One or more embodiments of the present disclosure include a method. The method may include positioning a spacer body over a portion of a delivery device distal to an implant holding area of ​​the delivery device. The method may include positioning a prosthetic implant over the delivery device.

[0019] The method may include abutting a distal end of the artificial implant against a contact surface of the spacer body to define a position of the artificial implant on the delivery device. The method may include crimping the artificial implant to the delivery device at that position.

[0020] One or more embodiments of the present disclosure include a system that may include an elongate body including a channel for receiving an elongate shaft of a delivery device having a proximal portion and a distal portion, the elongate body configured to bend in at least one plane to move the distal portion of the delivery device proximal to the proximal portion of the delivery device.

[0021] One or more embodiments of the present disclosure include a method that may include bending an elongate body including a channel that receives an elongate shaft of a delivery device in at least one plane to bend the elongate shaft so that a distal portion of the delivery device is positioned adjacent a proximal portion of the delivery device.

[0022] One or more embodiments of the present disclosure include a crimping system for a prosthetic implant. The crimping system may include a plurality of elongated strands, each having a first end and a second end, arranged to form an elongated tube, the elongated tube extending about an axis, surrounding a channel configured to receive the prosthetic implant, and having a central portion with an inner diameter. The crimping system may include a first support coupled to the first end of each of the plurality of elongated strands. The crimping system may include a second support coupled to the second end of each of the plurality of elongated strands, configured to rotate about an axis relative to the first support to reduce the inner diameter and compress the prosthetic implant within the channel.

[0023] One or more embodiments of the present disclosure include a method. The method may include positioning a prosthetic implant within a channel of a crimping device. The crimping device may include a plurality of elongated strands, each having a first end and a second end, arranged to form an elongated tube, the elongated tube extending around an axis, surrounding the channel, and having a central portion with an inner diameter; a first support coupled to the first end of each of the plurality of elongated strands; and a second support coupled to the second end of each of the plurality of elongated strands. The method may include rotating the second support about an axis relative to the first support to reduce the inner diameter and compress the prosthetic implant within the channel. [Brief explanation of the drawings]

[0024] The features and advantages of the systems, apparatus, and methods as disclosed herein will be appreciated as they become better understood with reference to the specification, claims, and accompanying drawings.

[0025] [Figure 1] 1 illustrates a side perspective view of a prosthetic implant according to an embodiment of the present disclosure. [Figure 2] 2 illustrates a top view of the prosthetic implant shown in FIG. 1 with the leaflets of the implant in a closed position. [Figure 3] 2 illustrates a top view of the prosthetic implant shown in FIG. 1 with the leaflets of the implant in an open position. [Figure 4] 1 illustrates a side view of a delivery device according to an embodiment of the present disclosure. [Figure 5] 1 illustrates a detailed view of a portion of a delivery device according to an embodiment of the present disclosure. [Figure 6] 1 illustrates a rear perspective view of a crimping device according to an embodiment of the present disclosure. [Figure 7] 7 illustrates a front perspective view of the crimping device shown in FIG. 6; [Figure 8] 1 illustrates a front perspective view of a support according to an embodiment of the present disclosure. [Figure 9] 9 illustrates a rear perspective view of the support shown in FIG. 8 according to an embodiment of the present disclosure. [Figure 10] 9 illustrates a side cross-sectional view of the support shown in FIG. 8 according to an embodiment of the present disclosure. [Figure 11] 1 illustrates a front perspective view of a ring body according to an embodiment of the present disclosure. [Figure 12] 12 illustrates a rear perspective view of the ring body shown in FIG. 11 according to an embodiment of the present disclosure. [Figure 13] 12 illustrates a cross-sectional view of the ring body shown in FIG. 11. [Figure 14] 12 illustrates the ring body shown in FIG. 11 positioned on the support shown in FIG. 8. [Figure 15] 15 illustrates a side view of a ring body positioned on a support in the configuration shown in FIG. 14. [Figure 16] 1 illustrates a perspective view of a positioning device positioned on a delivery apparatus according to an embodiment of the present disclosure. [Figure 17] 1 illustrates a front view of a prosthetic implant positioned on a support and adjacent a ring body according to an embodiment of the present disclosure. [Figure 18] 1 illustrates a perspective view of a prosthetic implant positioned on a support and inserted into a crimping device. [Figure 19]1 illustrates a side cross-sectional view of an implant positioned on a support and positioned within a crimping device. [Figure 20] 20 illustrates a side cross-sectional view of the support shown in FIG. 19 being ejected from a crimping device. [Figure 21] 1 illustrates a rear perspective view of a support configured to be inserted into a crimping device according to an embodiment of the present disclosure. [Figure 22] FIG. 1 illustrates a rear perspective view of a stopper housing according to an embodiment of the present disclosure. [Figure 23] 23 illustrates a front perspective view of the stopper housing shown in FIG. 22. [Figure 24] 23 illustrates a side cross-sectional view of the stopper housing shown in FIG. 22. [Figure 25] 1 illustrates a front perspective view of a crimping device according to an embodiment of the present disclosure. [Figure 26] 23 illustrates a side cross-sectional view of the stopper housing shown in FIG. 22 coupled to a crimping device according to an embodiment of the present disclosure. [Figure 27] 1 illustrates a front perspective view of a stopper housing according to an embodiment of the present disclosure. [Figure 28] FIG. 1 illustrates a rear perspective view of a stopper housing according to an embodiment of the present disclosure. [Figure 29] 1 illustrates a side view of a spacer body according to an embodiment of the present disclosure. [Figure 30] 30 illustrates a cross-sectional view of the spacer body shown in FIG. 29. [Figure 31] FIG. 30 illustrates a side perspective view of the spacer body shown in FIG. 29 with a partially crimped implant positioned within the spacer body. [Figure 32] 30 illustrates a side view of a nosecone positioned within the spacer body shown in FIG. 29. [Figure 33] FIG. 30 illustrates a side view of a partially crimped implant positioned within the spacer body shown in FIG. 29. [Figure 34]30 illustrates the spacer body shown in FIG. 29 positioned relative to a crimping device according to an embodiment of the present disclosure. [Figure 35] FIG. 1 illustrates a rear perspective view of a spacer body according to an embodiment of the present disclosure. [Figure 36] FIG. 36 illustrates a front perspective view of the spacer body shown in FIG. 35. [Figure 37] 36 illustrates a side cross-sectional view of the spacer body shown in FIG. 35. [Figure 38] 1 illustrates a side view of a spacer body according to an embodiment of the present disclosure. [Figure 39] 39 illustrates a side cross-sectional view of the spacer body shown in FIG. 38. [Figure 40] 1 illustrates a perspective view of a spacer body according to an embodiment of the present disclosure. [Figure 41] 41 illustrates a perspective view of the spacer body shown in FIG. 40 with a portion shown in cross section. [Figure 42] 1 illustrates a perspective view of an elongate body according to an embodiment of the present disclosure. [Figure 43] FIG. 43 illustrates a side view of the elongate body shown in FIG. 42. [Figure 44] 43 illustrates a perspective view of the elongate body shown in FIG. 42 in a bent configuration. [Figure 45] 1 illustrates a side cross-sectional view of a portion of an elongate body according to an embodiment of the present disclosure. [Figure 46] 1 illustrates a side cross-sectional view of a portion of an elongate body according to an embodiment of the present disclosure. [Figure 47] 1 illustrates a side cross-sectional view of a portion of an elongate body according to an embodiment of the present disclosure. [Figure 48] 1 illustrates a delivery device positioned within an elongate body according to an embodiment of the present disclosure. [Figure 49] 49 illustrates the elongate body shown in FIG. 48 in a bent configuration, according to an embodiment of the present disclosure. [Figure 50] 1 illustrates a side view of a portion of an elongate body according to an embodiment of the present disclosure. [Figure 51] 51 illustrates a side view of a portion of the elongate body shown in FIG. 50 in a bent configuration. [Figure 52]1 illustrates a side view of an elongate body according to an embodiment of the present disclosure. [Figure 53] 53 illustrates a cross-sectional view of the elongate body shown in FIG. 52 taken along line 53-53. [Figure 54] 1 illustrates a perspective view of a prosthetic implant positioned on a support and inserted into a crimping device. [Figure 55] 1 illustrates a side cross-sectional view of an implant positioned on a support and positioned within a crimping device. [Figure 56] 56 illustrates a side cross-sectional view of the support shown in FIG. 55 being ejected from a crimping device. [Figure 57] 1 illustrates a side view of a crimping device according to an embodiment of the present disclosure. [Figure 58] FIG. 58 illustrates a cross-sectional schematic view of the crimping device shown in FIG. 57. [Figure 59] FIG. 58 illustrates a perspective end view of the crimping device shown in FIG. 57. [Figure 60] 58 illustrates a cross-sectional schematic view of the crimping device taken along line AA of FIG. 57. [Figure 61] 58 illustrates the crimping device shown in FIG. 57 with an artificial implant positioned therein. [Figure 62] 58 illustrates a cross-sectional schematic view of the crimping device shown in FIG. 57 with an artificial implant positioned therein. [Figure 63] FIG. 58 illustrates a side view of the crimping device shown in FIG. 57 with an artificial implant crimped thereon. [Figure 64] 58 illustrates a cross-sectional view of the crimping device shown in FIG. 57 with an artificial implant crimped thereon. [Figure 65] FIG. 58 illustrates a cross-sectional schematic view of the crimping device shown in FIG. 57 with the capsule extending over the crimped prosthetic implant. [Figure 66] 1 illustrates a cross-sectional view of a crimping device according to an embodiment of the present disclosure. [Figure 67] 1 illustrates a cross-sectional view of a crimping device according to an embodiment of the present disclosure. [Figure 68A]1 illustrates a perspective view of a prosthetic implant according to an embodiment of the present disclosure. [Figure 68B] 1 illustrates a perspective view of a prosthetic implant according to an embodiment of the present disclosure. [Figure 68C] 1 illustrates a perspective view of a prosthetic implant according to an embodiment of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0026] 1 illustrates a perspective view of a prosthetic implant 10 in the form of a replacement heart valve. The prosthetic implant 10 may be configured to be deployed within a portion of a patient's body. The prosthetic implant 10 may be deployed within a native heart valve annulus, which may include, for example, a native aortic valve, or in embodiments, may include a native mitral, tricuspid, or pulmonary valve. In embodiments, the implant 10 may have other configurations and may include a stent or other form of medical implant, as desired.

[0027] The prosthetic implant 10 may include a proximal end 12 and a distal end 14, and a length therebetween. The prosthetic implant 10 may include a body in the form of a frame 16. The prosthetic implant 10 may further include one or more of a plurality of leaflets 18a-c coupled to the frame 16, and may include a skirt 20 covering an outer surface of a distal portion of the frame 16.

[0028] The frame 16 may include a plurality of struts 22 connected at junctions 24. A plurality of openings 26 may be positioned between the struts 22. The openings 26 may be configured to reduce the overall weight of the frame 16 and also allow the frame 16 to be compressed to reduce the diameter of the frame 16 and expanded to increase the diameter of the frame 16. The frame 16 may be configured to be radially compressed and lengthen axially while radially compressed. The struts 22 may be configured such that the length of the frame 16 may increase as the frame 16 is compressed to reduce the diameter of the frame 16. Also, the length of the frame 16 may decrease as the frame 16 is expanded to increase the diameter of the frame 16. The frame 16 may be compressed in various manners, including using a crimping device, and expanded in various manners, including being balloon-expanded, self-expandable, or mechanically expandable. While embodiments herein may refer to balloon-expandable implants, self-expandable or mechanically expandable implants may be utilized as well.

[0029] The frame 16 may include an outer surface 28 configured to press against the internal vasculature of the patient's body. For example, when the frame 16 is expanded, the outer surface 28 may contact and press against the internal vasculature of the patient's body. In embodiments, the outer surface 28 may press against the natural annulus or leaflets of the heart valve. The frame 16 may include an inner surface 30 (marked in FIG. 2 ) configured to face opposite the outer surface 28 and toward the flow path of the implant 10.

[0030] 1, the skirt 20 may cover the outer surface 28 of the distal portion of the frame 16 and may include a membrane or other form of skirt 20. The skirt 20 may improve the compliance of the frame 16 with the native valve into which the implant 10 is implanted and may be utilized to couple the leaflets 18a-c to the frame 16 via another form of coupler suture.

[0031] A plurality of leaflets 18a-c (shown more clearly in FIG. 2) may extend inward from the inner surface 30 of the frame 16. The leaflets 18a-c may be configured to move toward one another to move to a closed position (shown in FIG. 2) and away from one another to move to an open position (shown in FIG. 3). The leaflets 18a-c may each include upper end portions 32a-c (marked in FIG. 3) configured to contact one another to close a flow path through the implant 10 when the leaflets 18a-c are in the closed position. The upper end portions 32a-c are configured to move away from one another to open a flow path through the implant 10 when the leaflets 18a-c are in the open position. The leaflets 18a-c may move back and forth between open and closed positions, states, or configurations to mimic the movement of a natural valve.

[0032] Each leaflet 18a-c may include an inner surface 34a-c (marked in FIG. 3) configured to face toward the flow path of the implant 10 and an outer surface 36a-c (marked in FIG. 2) facing opposite the inner surfaces 34a-c and facing away from the flow path 37 of the implant 10. Portions of the inner surfaces 34a-c of each leaflet 18a-c may contact one another when the leaflets 18a-c move to a closed position.

[0033] Each leaflet 18a-c may include a respective outer portion 38a-c (marked in FIG. 2) that couples to the frame 16 of the implant 10. The coupling may have various configurations. For example, each leaflet 18a-c may include a tab 40a-f on its respective outer portion 38a-c. Tabs 40a, b may extend from leaflet 18a, tabs 40c, d may extend from leaflet 18b, and tabs 40e, f may extend from leaflet 18c. Tabs 40a-f may extend through openings in the frame 16 to couple to the frame 16 and then be sutured to hold the tabs 40a-f in place. Tabs 40a-f may form commissures of adjacent leaflets 18a-c.

[0034] Additionally, the outer portions 38a-c of each leaflet 18a-c may be sewn to the skirt 20 along suture lines 42a-c. For example, the lower end portion of each leaflet 18a-c opposite the upper end portions 32a-c may be sewn to the skirt 20 with respective suture lines 42a-c. The sewn suture lines 42a-c may hold the leaflets 18a-c to the frame 16 and prevent undesired fluid flow through the implant 10 outside of the flow channels 37.

[0035] The leaflets 18a-c may be configured to open and close during operation such that the proximal end 12 of the implant 10 forms the outflow end of the implant 10 and the distal end 14 of the implant 10 forms the inflow end of the implant 10. The leaflets 18a-c may be configured to prevent fluid flow in the opposite direction from the outflow end to the inflow end of the implant 10 when the leaflets 18a-c are in the closed position.

[0036] In embodiments, other forms of implants may be utilized, such as stents or other forms of medical devices. The configuration of the implants shown in Figures 1-3 may be varied in embodiments.

[0037] The implant 10 may be configured to be delivered to an implantation site utilizing a delivery device. FIG. 4, for example, illustrates an embodiment of a delivery device 44 that may be utilized to deliver the implant 10 to a desired implantation site. The delivery device 44 may include an elongate shaft 46 having a distal portion 48 and a proximal portion 50. The proximal portion 50 may be coupled to a housing in the form of a handle 52. The distal portion 48 may include an implant holding area 54 and a distal tip that may include a nosecone 56. The distal portion 48 may further include an inflatable body in the form of a balloon 58. The delivery device 44 may be configured to be positioned within a crimping device to crimp the implant 10 to the implant holding area 54. The elongate shaft 46 may be positioned within the crimping device. The balloon 58 may be configured to have the implant 10 crimped onto it.

[0038] The handle 52 may be configured for a user to grasp and manipulate the delivery device 44 and to navigate the delivery device 44 through the vascular system of a patient's body. For example, the handle 52 may be moved distally to advance the elongate shaft 46 distally within the patient's body, and may be moved proximally to retract the elongate shaft 46 proximally within the patient's body. Thus, the implant holding area 54, and thus the implant 10, may be moved and positioned by manipulation of the handle 52.

[0039] A control mechanism 60 may further be coupled to the handle 52. The control mechanism 60 may be configured to be manipulated to bend the elongate shaft 46, as desired. For example, one or more pull tethers may extend along the elongate shaft 46, and manipulation of the control mechanism 60 may push or pull the one or more pull tethers to bend the elongate shaft 46. Thus, bending of the elongate shaft 46 may be controlled by the control mechanism 60. As shown in FIG. 4, the control mechanism 60 may include a rotatable body in the form of a control knob that can be rotated to push or pull the pull tethers and bend the elongate shaft 46. Other forms of control mechanisms may be utilized, as desired.

[0040] A fluid port 62 may further be coupled to the handle 52 and may be utilized to transfer fluid to and from the balloon 58, as desired. The configuration of the handle 52 may be varied in other embodiments, as desired.

[0041] FIG. 5 illustrates an enlarged view of the distal portion 48 of the elongate shaft 46. The elongate shaft 46 may include one or more shafts, which may include one or more sheaths extending over one another. For example, the elongate shaft 46 may include an outer sheath 64, which may be configured to extend over and be slidable relative to an intermediate sheath 66, which may include a central shaft or shaft within the outer sheath 64 (within the lumen of the outer sheath 64). The intermediate sheath 66 may extend over an inner shaft 68, which may extend to a nosecone 56 of the elongate shaft 46. The inner shaft 68 may be surrounded by a balloon 58. The inner shaft 68 of embodiments may include fluid conduits that allow fluid to enter and exit the balloon 58 for inflating and deflating the balloon 58, respectively. Other shafts may include one or more fluid conduits for inflating and deflating the balloon 58, as desired.

[0042] The inner shaft 68 may further include a distal shoulder 70 that may be positioned distal to the implant holding area 54. The distal shoulder 70 includes a portion of the delivery device 44 positioned distal to the implant holding area 54, as well as other portions, such as the distal tip, including the nosecone 56 and distal end 72, of the balloon 58. The distal shoulder 70 may protrude radially outward from the inner shaft 68 and may have a conical shape, if desired. The taper of the conical shape may be configured such that the size of the distal shoulder 70 increases in a direction toward the implant holding area 54. The distal shoulder 70 may be configured to protect the implant 10 positioned within the implant holding area 54 as the elongate shaft 46 is advanced through the patient's body. For example, the outer diameter of the distal shoulder 70 may be equal to or greater than the diameter of the implant 10 when the implant 10 is in a crimped state, thus shielding the leading edge (such as the distal end 14 of the implant 10) from contacting a portion of the patient's body or from catching or getting caught in a sheath through which the elongate shaft 46 may be advanced.

[0043] The balloon 58 may have a distal end 72 and a proximal end 74 and may extend over the inner shaft 68 and a distal shoulder 70. The distal end 72 may be coupled to the nosecone 56, and the proximal end 74 may be coupled to the intermediate sheath 66. The balloon 58 may extend along the length of the inner shaft 68 and may surround the inner shaft 68. The balloon 58 is shown in a deflated state in FIG. 5 and may have a distal shoulder 76 and a proximal shoulder 78. The implant retention area 54 may have a length 80 between the distal shoulder 76 and the proximal shoulder 78. The balloon 58 may include an intermediate portion 82 between the distal shoulder 76 and the proximal shoulder 78, which may have a diameter that is less than the diameters of the distal shoulder 76 and the proximal shoulder 78. The diameter of the intermediate portion 82 may be constant in embodiments, as desired.

[0044] In particular, in embodiments, the proximal shoulder 78 of the balloon 58 may be shaped as a shoulder without extending over the shoulder of the inner shaft 68. As such, the inner shaft 68 may, in embodiments, lack an internal proximal shoulder.

[0045] In embodiments, the inner shaft 68 may include a shoulder proximal to the implant holding area 54. In such embodiments, the proximal shoulder 78 of the balloon 58 may extend over the proximal shoulder of the inner shaft 68.

[0046] The implant holding area 54 can be configured such that the implant 10 is crimped onto the balloon 58 and positioned within an intermediate portion 82 between the distal and proximal shoulders 76, 78 of the balloon 58. The implant 10 can be positioned proximal to the distal shoulder 76 and crimped in such position. In certain embodiments, the outer sheath 64 can be advanced distally to cover the implant 10 positioned within the implant holding area 54 when the implant 10 is crimped. In certain embodiments, the outer sheath 64 can be advanced distally relative to the intermediate sheath 66 to abut the proximal edge (or proximal end 12) of the implant 10.

[0047] In embodiments, the configuration of the delivery device may be varied from that shown in FIGS.

[0048] The implant 10 can be crimped onto the implant holding area 54 in a variety of ways. FIG. 6, for example, illustrates a rear perspective view (or a view from the proximal side of the crimping device 84) of a crimping device 84. The crimping device 84 can include a base 86, an actuator in the form of a handle 88, and a channel 90 for insertion of the implant 10 and delivery device 44. The crimping device 84 can include a proximal face 92 including a proximal opening 94 leading into the channel 90. The proximal opening 94 can be configured to allow the delivery device 44 to be inserted through the channel 90. The proximal face 92 can further include a mating structure 96 in the form of a notch that can be configured to mate with a positioning device 172, as shown in FIG. 16, for example. The proximal face 92 can further include a cutout portion 97 that can be configured to receive an alignment device of a support body disclosed herein. The cutout portion 97 can be configured as a notch or other shape in the proximal face 92.

[0049] The crimping device 84 may further include a rotatable body 98 configured to rotate with rotation of the handle 88. The crimping device 84 may be configured to operate via a plurality of pressing surfaces 100 surrounding the channel 90 and apply a compressive force to radially compress the implant 10 positioned within the channel 90. The pressing surfaces 100 may surround an axis 102 of the channel 90. The pressing surfaces 100 may be configured such that as the rotatable body 98 is rotated, the body presses against the pressing surfaces 100, causing them to move toward the center of the channel 90, reducing the diameter of the channel 90. The pressing surfaces 100 may form an iris structure, allowing the pressing surfaces 100 to move toward the center of the channel 90 and reduce the diameter of the channel 90. The implant 10 positioned within the channel 90 will accordingly be compressed within the channel 90 due to the radial compressive force of the pressing surfaces 100 against the implant.

[0050] 7 illustrates a front perspective view (or a view from the distal side of crimping device 84) of crimping device 84. Crimping device 84 may include a distal face 104 that includes a distal opening 106 that leads into channel 90. Distal face 104 may include a cutout portion 108, which may be configured as a notch or other shape in distal face 104.

[0051] The distal opening 106 may be configured to allow a portion of the delivery apparatus 44 to pass through when a crimping operation is being performed by the crimping device 84 .

[0052] The configuration of the crimping device may vary in embodiment as desired.

[0053] During operation, the implant 10 may be positioned on the implant holding area 54 of the delivery device 44, and then the delivery device 44 with the implant 10 positioned thereon may be inserted into the channel 90. However, adverse conditions may result for the implant 10, particularly if the leaflets 18a-c of the implant 10 are in a closed position (as depicted in FIG. 2) upon crimping of the implant 10 onto the delivery device 44. For example, when the implant 10 is crimped onto the delivery device 44 with the leaflets 18a-c in a closed position, one or more sutures connecting the leaflets 18a-c to the frame 16 may have elongated suture holes. The suture holes may be elongated along one or more suture lines 42a-c, as shown in FIG. 2. Elongation of the suture holes may result in various adverse conditions, including separation of the leaflets 18a-c from the frame 16, and may result in a reduction in the integrity of the fluid seal outside the flow passage 37 (marked in FIG. 3) of the implant 10. Further adverse conditions may include undesired pull-out of tabs 40a-f or misalignment of tabs 40a-f at the commissures, as shown in Figure 2. Positioning leaflets 18a-c in an open position during crimping of implant 10 is believed to reduce one or more of the adverse conditions described above.

[0054] The support may be utilized to support one or more leaflets 18a-c in the open position. FIG. 8, for example, illustrates a perspective view of a support 110 according to an embodiment of the present disclosure. The support 110 may be configured to be inserted into a crimping device and may have a support surface 112 configured to be positioned between one or more leaflets 18a-c and a delivery apparatus 44 and to support the one or more leaflets 18a-c in the open position. The support 110 may have a first end portion 114 and extend to a second end portion 116 that includes the support surface 112. The support 110 may comprise a system for use in crimping a prosthetic implant having one or more leaflets onto a delivery apparatus, and the system may include other components as desired.

[0055] First end portion 114 may have a cylindrical shape with a cylindrical outer surface 118. First end portion 114 may extend to a proximally-facing surface 120, which may extend transversely to cylindrical outer surface 118. Proximally-facing surface 120 may join first end portion 114 to second end portion 116, which includes support surface 112. Proximally-facing surface 120 may include an alignment device in the form of a recess 122, which may be configured to receive coupler 170 of ring body 138, as shown in FIG. 12 .

[0056] An alignment device 124 may be positioned on the first end portion 114 and configured to rotationally align the support 110 with the crimping device 84. The alignment device 124 may be positioned circumferentially on the first end portion 114 in a fixed position to rotationally align the support 110 with the crimping device 84. The alignment device 124 may comprise an axially extending protrusion as shown in FIG. 8 or, in other embodiments, may have other configurations, such as a recess or other form of alignment device. The alignment device 124 may be configured to be inserted into a notched portion 108 on the distal face 104 of the crimping device 84 to rotationally align the support 110 with the crimping device 84. The alignment device 124 may further be configured to allow the support 110 to slide distally out of the notched portion 108 when the crimping device 84 is operated. In embodiments, alignment device 124 may be inserted into the proximal face of crimping device 84, for example, into notched portion 97 as shown in FIGS.

[0057] The second end portion 116 may extend proximally from the first end portion 114. The support 110 at the second end portion 116 may include a bearing surface 112. The bearing surface 112 may have a tapered shape that tapers downward toward the second end portion 116. The diameter of the bearing surface 112 decreases in a direction toward the second end portion 116. The bearing surface 112 may have a conical shape as shown in FIG. 8 or another shape as desired in other embodiments. The bearing surface 112 may have a maximum diameter that is less than the diameter of the cylindrical first end portion 114, as shown in FIG. 8, or may have another configuration as desired. A connector portion 126 (marked in FIG. 10) may join the bearing surface 112 to the proximally-facing surface 120 and may have a cylindrical shape with a constant diameter or another shape as desired.

[0058] The support surface 112 can be configured to contact and rest on the inner surfaces 34a-c of the valve leaflets 18a-c (marked in FIG. 3 ) when the implant 10 is positioned on the support surface 112. The support surface 112 can be configured to resist movement of the valve leaflets 18a-c to a closed position when the implant 10 is positioned on the support surface 112 and within the crimping device 84.

[0059] The tapered shape of the support surface 112 may allow the support 110 to slide distally when the pressing surface 100 of the crimping instrument 84 presses over the support surface 112. Thus, the tapered shape may cause the pressing force applied by the pressing surface 100 to move proximally along the tapered shape of the support surface 112, thereby moving the support 110 distally in response. However, the support surface 112 may still maintain the leaflets 18a-c in an open position when the pressing surface 100 presses against the tapered support surface 112. The tapered shape of the support's support surface may include a wide portion and a narrow portion, and positioning the prosthetic implant on the support may include positioning the prosthetic implant on the support such that one or more leaflets open in a direction from the wide portion toward the narrow portion. The support 110 may be configured to slide axially away from the implant 10 when the crimping device 84 crimps the implant 10. The support 110 may be configured, for example, to be inserted into the channel 90 of the crimping device 84 and to slide axially away from the channel 90 when the crimping device 84 crimps the implant 10, and may slide axially distally within the channel away from the artificial implant.

[0060] The support 110 may include a central opening 128 that leads to a central channel 130. The central opening 128 and the central channel 130 may be configured for the delivery device 44 to extend therethrough. The support surface 112 may extend around the central channel 130. The central opening 128 may be positioned on the second end portion 116, and the central channel 130 may extend from the second end portion 116 to the first end portion 114.

[0061] 9 illustrates a distal perspective view of support 110. First end portion 114 includes a distally facing surface 134 that extends perpendicular to and joins cylindrical outer surface 118. Distally facing surface 134 includes a central opening 136 that leads to central channel 130, which extends to central opening 128 (shown in FIG. 8) in second end portion 116.

[0062] 10 illustrates a cross-sectional view of the support 110. The central channel 130 is shown extending from the distal central opening 136 to the proximal central opening 128.

[0063] During operation, the implant 10 can be slid distally onto the support surface 112 of the support 110, with the frame 16 extending over the support surface 112 and the inner surfaces 34a-c of the leaflets 18a-c on the support surface 112. In embodiments, the implant 10 can be slid distally from the distal end 14 of the implant 10 in a direction from the second end portion 116 to the first end portion 114. In embodiments, the implant 10 can be slid onto the support with the proximal end of the implant leading. Such a configuration can be used when an opposite delivery path to the implant site can be utilized rather than a path led by the distal end of the implant. A ring body can be utilized and positioned on the support 110 to align the leaflets 18a-c in a desired rotational orientation on the support surface 112 and space the implant 10 from the proximally-facing surface 120 by a desired distance.

[0064] 11 illustrates a perspective view of a ring body 138 that may be utilized with, for example, the support 110. The ring body 138 may be configured to extend around the support 110. The ring body 138 may include a first surface, which may be a proximally-facing surface 140, a second surface (marked in FIG. 12) facing opposite the first surface and which may be a distally-facing surface 142, and an outer surface 144 that faces outward and connects the proximally-facing surface 140 to the distally-facing surface 142. The ring body 138 may include an inner surface 146 facing opposite the outer surface 144 and facing toward and surrounding a central channel 148 of the ring body 138.

[0065] The alignment guide may be positioned on the ring body 138 and may include one or more indicators 150a-c that indicate the rotational position of the implant 10 relative to the ring body 138. Each indicator 150a-c may indicate the rotational position of the implant 10 on the support 110. Each indicator 150a-c may include a marking or other form of indicator on one or more of the proximal-facing surface 140, the distal-facing surface 142, or the outer surface 144 of the ring body 138. Each indicator 150a-c may include a change in the surface contour of the ring body 138, such as, for example, a raised portion or a recessed portion. The indicators 150a-c shown in FIG. 11 each include, for example, a recessed portion in the form of a groove on the proximal-facing surface 140 that extends to the outer surface 144. The indicators 150a-c may additionally be printed on to change the color of the respective indicator 150a-c so that the indicator is more easily visualized. In some embodiments, the indicators 150a-c may be printed solely on the ring body 138 without the use of surface contour variations.

[0066] The indicators 150a-c may be circumferentially spaced apart from one another on the ring body 138 and may be equally spaced apart from one another. The position of each indicator 150a-c may correspond to the position of one or more leaflets 18a-c of the implant 10. The position of each indicator 150a-c may correspond to and indicate the position of one or more commissures of one or more leaflets 18a-c, for example. Thus, a user may position the ring body 138 on the support 110 and align the commissures of the leaflets 18a-c with the respective indicators 150a-c.

[0067] The ring body 138 includes one or more arms 152, 154, each extending around the central channel 148. Each arm 152, 154 may have an arcuate shape that forms the ring body 138. Each arm 152, 154 may include half of the ring body 138, or another amount as desired.

[0068] The first arm 152 may include a first end portion 156 and a second end portion 158, with the first end portion 156 positioned at a pivot point 160 that couples the first arm 152 to the second arm 154. The second end portion 158 of the first arm 152 may include a coupler for coupling to the second arm 154. The second arm 154 may include the first end portion 162 positioned at the pivot point 160 and a second end portion 164 positioned at the coupler. The coupler may comprise a recess in the second end portion 158 of the first arm 152 and a protrusion on the second end portion 164 of the second arm 154. The protrusion may extend into the recess and be held in place with an interference fit or another form of coupling. Thus, the second end portions 158, 164 of the respective first and second arms 152, 154 may be configured to couple together and hold the ring body 138 together. When desired, the ring body 138 may be separated and removed from the support 110 with the second end portions 158, 164 separated from each other and the arms 152, 154 pivoted to an open position about the pivot point 160. The ring body 138 may be opened to be removed from the support 110 and closed to be retained on the support 110.

[0069] 11 , a first lever 166 can extend radially outward from the first arm 152, and a second lever 168 can extend radially outward from the second arm 154. The first lever 166 and the second lever 168 can each be configured to be depressed to rotate the first arm 152 or the second arm 154 about the pivot point 160 and move the ring body 138 to the open position.

[0070] The ring body 138 may have an axial width 171 that may define the spacing of the implant 10 from the proximally facing surface 120 of the support 110 shown in FIG.

[0071] FIG. 12 illustrates a distal perspective view of the ring body 138. The coupler 170 may extend distally from the distally-facing surface 142. The coupler 170 may be configured as a protrusion or other form of coupler. The coupler 170 may be configured to extend into the recess 122 shown in FIG. 8. The coupler 170 may be positioned circumferentially relative to the recess 122 such that the ring body 138 mates with the support 110 in a desired rotational alignment. The coupler 170 may rotationally align the ring body 138 with the support 110.

[0072] 13 illustrates a cross-sectional view of ring body 138. Insertion of second end portion 164 of second arm 154 into the recess of second end portion 158 of first arm 152 is shown in FIG.

[0073] In operation, ring body 138 can be positioned on support 110 with indicators 150a-c positioned in a desired rotational alignment relative to support 110. Coupler 170, shown in FIG. 12, for example, can enter recess 122 in a rotational position such that ring body 138 is rotationally positioned as desired relative to support 110. FIG. 14, for example, illustrates ring body 138 on support 110 with coupler 170 inserted into recess 122. FIG. 15 illustrates a side view of ring body 138 on support 110 with coupler 170 inserted into recess 122. In other embodiments, other alignment devices can be utilized to rotationally align ring body 138 relative to support 110 in a desired rotational alignment.

[0074] The ring body 138 may abut the proximally-facing surface 120 shown in FIG. 8. The axial width 171 of the ring body 138, shown in FIG. 11, may define the spacing of the implant 10 from the proximally-facing surface 120 of the support 110. The ring body 138 may be configured to abut the prosthetic implant 10 when the prosthetic implant 10 is positioned on the support 110. Thus, the implant 10 may be positioned on the support surface 112 with an end of the implant 10 abutting the proximally-facing surface 140 of the ring body 138, defining the position of the implant 10 on the support surface 112. Thus, the ring body 138 may comprise a spacer configured to define the position of the implant 10 on the support 110.

[0075] The ring body 138 can be placed in an open configuration with the arms 152, 154 open, and then placed on the support 110 with the arms 152, 154 closed to secure the ring body 138 around the support 110. The ring body 138 can be positioned, for example, on the connector portion 126 shown in FIG.

[0076] The implant 10 may then be positioned on the support surface 112 and abut against the proximally-facing surface 140 of the ring body 138. The implant 10 may be positioned on the support surface 112 with the commissures of the leaflets 18a-c aligned with the indicators 150a-c and the ends of the implant 10 abutting the proximally-facing surface 140.

[0077] Use of the ring body 138 may beneficially allow the commissures of the leaflets 18a-c, and the leaflets 18a-c themselves, to be positioned in a desired rotational orientation relative to the ring body 138, and thus relative to the support 110. As shown in FIG. 8 , the alignment device 124 on the support 110 may rotationally align the support 110 with the crimping device 84, thus positioning the commissures of the leaflets 18a-c, and the leaflets 18a-c themselves, in a desired rotational orientation within the crimping device 84.

[0078] It may be desirable to crimp the implant 10 onto the delivery apparatus 44 in a known rotational orientation, with the leaflets 18a-c and their commissures in a known rotational orientation within the crimping device 84. Thus, a user crimping the implant 10 onto the delivery apparatus 44 may know the position of the leaflets 18a-c and their commissures on the delivery apparatus 44 when the implant 10 is crimped. Thus, during deployment of the implant 10 from the delivery apparatus 44, the user may be able to position the commissures and leaflets 18a-c in a desired orientation relative to the implantation site. For example, if the implant 10 is deployed into a native heart valve, the prosthetic leaflets 18a-c and their communications may be deployed in an orientation that closely matches the position of the native leaflets and commissures. Thus, more effective deployment of the implant 10 may result by positioning the leaflets 18a-c and their commissures in a known orientation relative to the delivery apparatus 44.

[0079] The support 110 and the ring body 138 can each be part of a system for use in crimping a prosthetic implant having one or more leaflets onto a delivery device. In embodiments, the system can include a positioning device 172 configured to couple to a portion of the delivery device 44 proximal to the implant holding area 54. FIG. 16, for example, illustrates an embodiment of such a positioning device 172 positioned proximal to the implant holding area 54. The positioning device 172 includes a body 174 including a first portion 176 and a second portion 178 joined by a hinge 180. The body 174 can include a central channel 182 within which the delivery device 44 can be positioned, with the second portion 178 rotating about the hinge 180 to close the central channel 182 and retain the delivery device 44 within the central channel 182.

[0080] The body 174 may further include a mating surface in the form of a flange 184 configured to engage with a mating structure 96 on the proximal face 92 of the crimping device 84 shown in FIG.

[0081] The positioning device 172 may be utilized to couple to the delivery apparatus 44 and suspend the shaft of the delivery apparatus 44 in a fixed position within the channel 90 of the crimping device 84. The positioning device 172 may thus hold the delivery apparatus 44 spaced apart from the pressing surface 100 of the crimping device 84, for example, as shown in FIG. 19 . Furthermore, the positioning device 172 may be positioned axially along the delivery apparatus 44 such that the implant holding area 54 is held within a defined axial position within the channel 90 of the crimping device 84. Such a feature may further enable the distal shoulder 70 of the inner shaft 68, shown in FIG. 5 , to be positioned outside and distal to the channel 90 of the crimping device 84 so that the distal shoulder 70 is not pressed by the pressing surface 100 during crimping. The delivery apparatus 44 may further be held in a defined axial position relative to the implant 10 positioned on the support 110.

[0082] The method of operation of the systems disclosed herein may include the following steps, which may be modified, omitted, or substituted across embodiments as desired.

[0083] In a first step, the implant 10 to be crimped may be soaked to improve the ease of crimping the implant 10 .

[0084] The ring body 138 can then be positioned on the support 110 in the configuration shown in FIG. 15, for example. The ring body 138 can be rotationally oriented on the support 110 at a defined position, for example, via coupling of the coupler 170 shown in FIG. 13 with the recess 122 shown in FIG. 8. In this manner, the implant 10 can be positioned on the support surface 112 with the commissures of the leaflets 18a-c oriented with the indicators 150a-c. The implant 10 can abut against the ring body 138 to define the position of the implant 10 on the support 110.

[0085] 18 illustrates, for example, implant 10 slid onto support surface 112 of support 110 with distal end 14 (marked in FIG. 1) abutting proximally-facing surface 140. Inner surfaces 34a-c of each of leaflets 18a-c contact support surface 112 of support 110 and are held in an open position. The commissures of leaflets 18a-c are aligned with indicators 150a-c. Implant 10 can be held axially spaced apart on support surface 112 corresponding to axial width 171 of ring body 138 (as marked in FIG. 11).

[0086] With the implant 10 positioned on the support surface 112, the ring body 138 can then be removed from the support 110 before crimping the implant 10 onto the delivery device 44. For example, the levers 166, 168 can be depressed to rotate the arms 152, 154 about the pivot point 160 and release the ring body 138.

[0087] Once the ring body 138 is removed, the support 110 can be inserted into the crimping device 84 with the implant 10 positioned on the support surface 112. FIG. 18 , for example, illustrates the implant 10 positioned on the support surface 112 with the implant 10 and support 110 inserted into the channel of the crimping device 84. The distal opening 106 of the crimping device 84 can be configured to allow the support 110 to be inserted into the channel 90 therethrough. The support 110 can be configured to be inserted into the distal opening 106 of the crimping device 84. The channel 90 of the crimping device 84 can be configured to receive the implant 10, the support 110, and the elongate shaft 46 of the delivery apparatus 44. Upon insertion of the support 110 into the channel of the crimping device 84, the alignment device 124 can be aligned with the notched portion 108 of the crimping device 84. Thus, the rotational orientation of the support 110 within the channel of the crimping device 84, and therefore the rotational orientation of the implant 10 within the channel 1090 of the crimping device 84, can be set.

[0088] Once the support 110 and implant 10 are inserted into the channel of the crimping device 84, a positioning device 172, shown in FIG. 16, may be coupled to a proximal portion of the delivery apparatus 44 and then inserted into the proximal opening 94 of the crimping device 84, as shown in FIG. 6. A flange 184 of the positioning device 172 may mate with the mating structure 96, shown in FIG. 6.

[0089] 19 illustrates a cross-sectional view of the pressure surface 100 in place around the channel 90 of the crimping device 84 and the support 110 inserted into the channel 90 with the implant 10 positioned on the support surface 112. The leaflets 18a-c are supported on the support surface 112 with the inner surfaces 34a-c of the leaflets 18a-c in contact with the support surface 112. The leaflets 18a-c extend proximally and are supported in an open position. The frame 16 of the prosthetic implant 10 extends proximally and surrounds the leaflets 18a-c and support surface 112, as well as the elongate shaft 46.

[0090] The support 110 extends proximally, with a second end portion 116 oriented proximally toward the proximal opening 94 of the crimping device 84. The support surface 112 may be surrounded by the pressing surface 100. The first end portion 114 of the support 110 may be positioned outward and distal to the pressing surface 100 and may be retained within the distal opening 106 of the crimping device 84. The alignment device 124 may extend proximally into the cutout portion 108 of the crimping device 84.

[0091] The elongate shaft 46 of the delivery device 44 is positioned within the channel 90 of the crimping device 84. The implant 10 is positioned within the channel 90 and around the delivery device 44. A support 110 is positioned within the channel 90 and between the valve leaflets 18a-c and the delivery device 44. The support 110 supports the valve leaflets 18a-c in the open position. The elongate shaft 46 of the delivery device 44 extends distally into the internal channel 90 of the crimping device 84 and into the central channel 130 of the support 110. The channel 90 can be configured such that the elongate shaft 46 of the delivery device 44 is advanced axially distally therethrough toward the distal opening 106. A support surface 112 extends around the elongate shaft 46 of the delivery device 44.

[0092] The positioning device 172 may be coupled to a proximal portion of the elongate shaft 46 of the delivery apparatus 44 and may engage with the mating structure 96 on the proximal face 92. The positioning device 172 may be coupled to the proximal portion of the shaft 46 at a location such that the implant retaining area 54 is positioned within the channel 90 at a desired location relative to the implant 10. For example, as shown in FIG. 19 , the implant 10 may surround the implant retaining area 54 with the proximal shoulder 78 of the balloon 58 positioned proximally of the implant 10 and the distal shoulder 76 of the balloon 58 positioned distally of the implant 10.

[0093] Additionally, the positioning device 172 may be coupled to the proximal portion of the shaft 46 at a location such that the distal shoulder 70 of the inner shaft 68 is positioned distal to the pressure surface 100 and therefore outside and distal to the channel 90. Such a feature may reduce the likelihood of the distal shoulder 70 being compressed by the pressure surface 100, which may reduce the likelihood of damage to the distal shoulder 70 that may reduce the ability of the distal shoulder 70 to shield the crimped implant 10.

[0094] Additionally, the rotational alignment of the implant 10 relative to the elongate shaft 46 may be in the desired alignment due to the prior use of the ring body 138 shown in FIG.

[0095] With the elongate shaft 46, support 110, and implant 10 in the desired position within the channel 90, the actuator of the crimping device 84 can be actuated to compress the implant 10. For example, as shown in FIG. 6 , the handle 88 can be rotated to rotate the rotatable body 98 and move the pressing surface 100 radially inward relative to the implant 10. FIG. 20 , for example, illustrates the pressing surface 100 being moved radially inward to apply a compressive force to the implant 10. The implant 10 is crimped onto the delivery apparatus 44 utilizing the pressing surface 100 of the crimping device 84. The implant 10 is compressed radially inward toward the implant holding area 54 of the elongate shaft 46. Additionally, the length of the implant 10 has increased axially. The proximal shoulder of the balloon 58 can be flattened or otherwise reduced in size.

[0096] The implant 10 may remain in the open position and be crimped with the leaflets 18a-c held in the open position. The support surface 112 may thus support the leaflets 18a-c as the pressing surface 100 is pressed against the implant 10. Crimping the implant 10 to the delivery device 44 may include using the pressing surface 100 to apply a force to the support surface 112 of the support 110 to slide the support 110 axially within the channel 90, away from the implant 10.

[0097] The tapered shape of the support surface 112 may allow the support 110 to slide distally away from and away from the channel 90 as the pressing surface 100 moves radially inward. The support 110 is configured to releasably couple to the crimping device 84 and to slide axially away from the channel 90 as the crimping device 84 crimps the implant 10. In embodiments, the support 110 may exit distally from the distal opening 106, as shown in FIG. 20 . The support 110 may exit with the distal tip of the elongated shaft 46 sliding proximally relative to the central channel 130 of the support 110 and out of the central opening 128, as shown in FIG. 8 . The support 110 may slide axially relative to the valve leaflets 18a-c. The elongated shape of the alignment device 124 may allow the alignment device 124 to slide distally out of the cutout portion 108.

[0098] In embodiments, the support 110 may not retract, but may remain coupled to the crimping device 84 during crimping. The support 110 may slide distally while a tether or another form of coupler keeps the support 110 coupled to the crimping device 84, for example, to prevent the support 110 from falling off.

[0099] Once the implant 10 is crimped onto the elongate shaft 46, the positioning device 172 may be disengaged from the mating structure 96 and moved proximally to retract the elongate shaft 46 proximally from the proximal opening 94. The positioning device 172 may be removed from the elongate shaft 46, with the implant 10 remaining crimped onto the implant retention area 54.

[0100] The use of the support 110 may beneficially allow the leaflets 18a-c of the implant 10 to remain in an open position during crimping. Such a feature may reduce the possibility of adverse conditions to the implant 10 during crimping. Furthermore, the tapered shape of the support surface 112 may allow the support 110 to be slid distally via radially inward movement of the pressing surface 100 such that the support 110 is automatically moved distally. The support 110 may automatically slide distally such that the support surface 112 is not positioned between the implant 10 and the pressing surface 100 after crimping. In embodiments, the system may be configured such that a separate mechanism slides the support 110 distally such that the tapered shape may not be utilized for the support surface 112. For example, an arm or gear or another form of coupler may engage the support 110 and move the support 110 away from the implant 10.

[0101] The use of the support 110 may further beneficially allow implants 10 of various sizes to be crimped with the same crimping device 84. When implants having various diameters or lengths are to be crimped using the crimping device 84, the size of the support surface 112 may be varied to accommodate the implant. The implant may then be positioned on the support surface, inserted into the channel 90 of the crimping device 84, and crimped onto an implant holding area sized for the implant. A positioning device 172 may be positioned along the length of the elongate shaft 46 to continue to maintain the distal shoulder 70 of the elongate shaft outside of the pressing surface 100.

[0102] FIG. 21 illustrates a distal perspective view of a variation of the support, including a support 190 having an alignment device 192 in the form of a recess in the outer surface of the support 190. An opening 193 in the distal face of the crimping device (not shown) is shown, with the opening 193 positioned on the distal face in a manner similar to the distal opening 106 shown in FIG. 7. The alignment device 192 can be configured to rotationally align the support 190 with an alignment guide 194 of the crimping device. For example, the alignment guide 194 can include a protrusion that slides within a recess in the alignment device 192 when the support 190 is slid proximally into the crimping device. Thus, the alignment device 192 can operate to rotationally align the support 190 in a manner similar to the alignment device 124 shown in FIG. 8.

[0103] The support 190 may be configured to engage with a retainer 195, which may be positioned on an inner surface 197 of the opening 193. The retainer 195 may be configured to selectively engage a catch on the support 190 to allow the support 190 to remain in place within the opening 193. The catch may disengage from the retainer 195 as the support 190 is slid distally. For example, the retainer 195 may include a detent device that biases to allow the catch to release and allow the support 190 to be slid distally. The relative positions of the retainer 195 and the catch may further rotationally align the support 190 with the opening 193.

[0104] The support 190 may further include a support surface 196 that operates similarly to the support surface 112 shown in Figure 8. The support 190 may further include a central channel 198 that operates similarly to the central channel 130 shown in Figure 10.

[0105] The support 190 may operate in a manner similar to that of the support 110 shown in FIGS.

[0106] In embodiments, other configurations of the support and ring body may be utilized as desired. Embodiments may be utilized separately or in conjunction with other components disclosed herein. In one embodiment, the support may be configured to be inserted proximally into the crimp body to engage, for example, the cutout portion 97 shown in FIG. 6. The support 110 may be configured to be inserted into the proximal opening 94 of the crimping device.

[0107] 54, for example, illustrates an implant 10 positioned on a support surface 112 with the implant 10 and support 110 inserted into a channel of the crimping device 84. The proximal opening 94 of the crimping device 84 can be configured to allow the support 110 to be inserted into the channel 90 therethrough. The channel 90 of the crimping device 84 can be configured to receive the implant 10, the support 110, and the elongate shaft 46 of the delivery apparatus 44.

[0108] As shown in Figures 11-15, in embodiments where the support 110 is inserted into the proximal opening 94 of the crimping device 84, the ring body 138 can be coupled to the support 110 and utilized to align the implant 10 on the support 110.

[0109] In embodiments in which the support 110 is inserted into the proximal opening 94 of the crimping device 84, the positioning device 172 shown in FIG. 16 may be omitted from use. Thus, the support 110 may be positioned in the proximal opening 94 of the crimping device 84 rather than the positioning device 172.

[0110] 55, for example, illustrates a distally extending support 110 with a second end portion 116 oriented distally toward the distal opening 106 of the crimping device 84. The support surface 112 may be surrounded by the pressing surface 100. A first end portion 114 of the support 110 may be positioned outward and proximal of the pressing surface 100 and may be retained within the proximal opening 94 of the crimping device 84.

[0111] The tapered shape of the support surface 112 may cause the support 110 to slide proximally away from the channel 90 and away from the pressing surface 100 as the pressing surface 100 moves radially inward. The support 110 is configured to releasably couple to the crimping device 84 and to slide axially away from the channel 90 as the crimping device 84 crimps the implant 10.

[0112] As shown in FIG. 56 , the support 110 may be proximally retracted from the proximal opening 94. The support 110 may be retracted by sliding the elongated shaft 46 distally relative to the central channel 130 of the support 110. The support 110 may slide axially relative to the leaflets 18a-c and may slide axially proximally away from the channel of the crimping device as the crimping device crimps the prosthetic implant. The elongated shape of the alignment device 124 may allow the alignment device 124 to slide proximally out of the cutout portion 97. The elongated shaft 46 may then be withdrawn proximally from the crimping device 84. The support 110 may be positioned around the elongated shaft 46 and then slid distally to be removed from the elongated shaft 46.

[0113] 54-56 may allow the implant 10 to be crimped onto the elongate shaft 46 of the delivery device in a direction opposite to that shown in FIGS. 18-20 (e.g., retrograde crimping rather than antegrade crimping as depicted in FIGS. 18-20). As such, the orientation of the leaflets 18a-c and the direction of flow through the implant 10 may be opposite to that depicted in FIGS. 18-20. In FIGS. 18-20, the implant 10 may be positioned on the elongate shaft 46 to allow fluid flow through the implant 10 in a proximal direction when implanted. However, in the embodiment shown in FIGS. 54-56, the implant 10 may be positioned on the elongate shaft 46 to allow flow in a distal direction when the implant 10 is implanted.

[0114] Thus, in the configurations shown in Figures 54-56, the implant 10 can be implanted at the implantation site in an orientation opposite to that shown in Figures 18-20. Therefore, the approach to the implantation site, such as the native valve, can be the opposite of the embodiment shown in Figures 54-56 rather than the embodiment shown in Figures 18-20. For example, in the embodiment of Figures 18-20, the approach to the aortic valve can be transarterial, over the aortic arch, and in a ventricular direction toward the aortic valve. The implant 10 can be implanted at the aortic valve with the flow direction extending away from the left ventricle. In the embodiment of Figures 54-56, the approach to the implantation site can be in the opposite direction relative to the implantation site (and the flow direction of the native valve). For example, the approach to the mitral valve can be transseptal (e.g., from the right atrium to the left atrium via a transseptal puncture), then in a ventricular direction toward the mitral valve. Thus, the implant 10 has a flow direction that is towards the ventricle, and therefore opposite to the direction depicted in Figures 18-20.

[0115] In embodiments, other approaches may utilize the orientation of implant 10 shown in Figures 54-56. For example, a transradicular approach or other approach may be utilized that requires an opposite orientation of implant 10 than the orientation depicted in Figures 18-20.

[0116] Other methods of crimping the implant 10 onto the delivery device may be utilized as desired. In embodiments, a user may be able to select whether to insert the support 110 into the proximal opening 94 or the distal opening 106. For example, the proximal opening 94 may be configured to allow a delivery device to be inserted into a channel therethrough, and the distal opening 106 may be configured to allow a support to be inserted into a channel therethrough. Additionally, the proximal opening 94 may be configured to allow a delivery device to be inserted into a channel therethrough, and the proximal opening 94 may also be configured to allow a support 110 to be inserted into a channel therethrough.

[0117] FIG. 22 illustrates an embodiment of a stopper housing 200 according to an embodiment of the present disclosure. The stopper housing 200 may comprise a system for use in crimping the artificial implant 10 onto the delivery device 44. The stopper housing 200 may include a cavity 202, marked in FIGS. 23 and 24, that may be configured to receive a portion of the delivery device 44 distal to the implant holding area 54 of the delivery device 44. The stopper housing 200 may include a contact surface 224 (marked in FIG. 24) configured to abut against the delivery device 44 and prevent axial distal movement of the delivery device 44 when the delivery device 44 is positioned within a crimping device 84 configured to crimp the artificial implant 10 onto the delivery device 44. The stopper housing may comprise a crimp stopper housing or a crimping assist device according to an embodiment.

[0118] 22 illustrates a distal perspective view of the stopper housing 200. The stopper housing 200 may include a body 204 having an outer surface 206 and having a large diameter proximal portion 208 and a small diameter distal portion 210. The outer surface 206 of the body 204 may include one or more couplers 212 configured to couple the stopper housing 200 to a portion of the crimping device 84. The couplers 212 may, for example, include a protrusion extending radially outward from the proximal portion 208 and positioned at a proximal end 214 of the proximal portion 208. The protrusion may extend from an arm extending axially along the body 204.

[0119] In embodiments, coupler 212 may be configured to selectively engage a portion of crimping device 84. For example, coupler 212 may be configured to deflect radially inward to allow stopper housing 200 to be engaged or disengaged with crimping device 84. Coupler 212 may be configured to deflect radially outward to allow stopper housing 200 to remain engaged with crimping device 84. FIG. 25, for example, illustrates a perspective view of distal opening 106 of crimping device 84. Crimping device 84 may include multiple receivers 109 circumferentially spaced about an opening of channel 90 through which coupler 212 may be configured to pass to engage stopper housing 200 with crimping device 84. In embodiments, other forms of coupling may be utilized.

[0120] The distal end 216 of the stopper housing 200 may include an opening 218 for passage of a portion of the delivery device 44. For example, the distal end of the delivery device 44 may be configured to pass completely or partially through the opening 218.

[0121] 23 illustrates a proximal perspective view of the stopper housing 200. The stopper housing may include a distal face 220 extending to the outer surface 206 of the stopper housing 200. The cavity 202 may extend distally from the distal face 220 of the stopper housing 200 and may extend from an opening 222 in the distal face 220.

[0122] FIG. 24 illustrates a cross-sectional view of the stopper housing 200. The stopper housing may include a contact surface 224. In embodiments, the contact surface 224 may comprise an inner surface of the cavity 202 and may define the shape of the cavity 202. In embodiments, the inner surface of the cavity 202 may be angled and have a tapered shape, as shown in FIG. 24. The inner surface 224, and thus the cavity 202, may be shaped to follow the shape of the delivery device, which may include the shape of the distal end of the delivery device 44. In this manner, the cavity 202 may be configured to receive the distal tip of the delivery device 44 with the contact surface 224 abutting the distal tip at a specific point of distal insertion of the delivery device 44. Thus, the contact surface 224 may impede distal movement of the distal tip of the delivery device 44. Contact surface 224 may be shaped to impede distal movement of the distal tip of delivery apparatus 44 at a specific point to position delivery apparatus 44 at a desired location within channel 90 of crimping device 84 .

[0123] In embodiments, contact surface 224 may be shaped to impede distal movement of the distal tip of the delivery device at a point where distal shoulder 70 of inner shaft 68 (marked in FIG. 5 ) is positioned distal to push surface 100 and outside of channel 90. Contact surface 224 may be configured to abut the delivery device with distal shoulder 70 of delivery device 44 positioned distal to and outside of channel 90 to impede axial distal movement of the delivery device within crimping device 84 and then channel 90, defining the position of the delivery device within channel 90. Such a feature may allow distal shoulder 70 of inner shaft 68 to not be compressed during crimping of implant 10 and therefore not be damaged during the crimping process. Thus, distal shoulder 70 may remain capable of shielding the leading edge of implant 10 (such as distal end 14 of implant 10). Thus, contact surface 224 may act as a stop point or reference for positioning distal shoulder 70 distal to pressure surface 100 and outside channel 90 .

[0124] In embodiments, cavity 202 may be configured to receive distal shoulder 70 of a delivery device such that distal shoulder 70 is positioned within cavity 202 during crimping. Distal shoulder 70 may be positioned within cavity 202 in embodiments, or may be positioned proximal to cavity 202 in embodiments. Other configurations may be utilized as desired. Additionally, in embodiments, a contact surface providing a stopping point or reference may be positioned outside of cavity 202 for receiving a delivery device.

[0125] 25 illustrates a distal perspective view of distal opening 106 and illustrates receiver 109 positioned circumferentially about opening 106. Receiver 109 can be configured to engage coupler 212 shown in FIG. 23 to engage stopper housing 200 to crimping device 84.

[0126] 26 illustrates a side cross-sectional view of stopper housing 200 engaged with crimping device 84. Stopper housing 200 may be positioned on the distal side of crimping device 84 at a distal opening and may be coupled to the distal opening of crimping device 84. Stopper housing 200 may be positioned with a cavity 202 positioned axially relative to channel 90. Delivery apparatus 44 is shown extending into channel 90 and is inserted distally into cavity 202.

[0127] During operation, an implant may be inserted into the channel 90 of the crimping device 84. A stopper housing 200 may be coupled to the crimping device 84 distal to the channel 90 on the distal side of the crimping device 84. The delivery device 44 may then be inserted distally into the channel 90 through the proximal opening 94 of the crimping device. The delivery device 44 may be advanced axially distally through the channel toward the distal opening. A portion of the delivery device 44 distal to the implant holding area 54 may abut against the stopper housing 200 to define the position of the delivery device 44 within the channel 90 of the crimping device 84. The delivery device 44 may be inserted distally until the distal end of the delivery device 44 abuts the contact surface 224 (marked in FIG. 24 ) of the stopper housing 200. The position where the delivery device 44 abuts the inner contact surface 224 may position the distal shoulder 70 distal to the push surface 100 and outside of the channel 90. In this way, the distal shoulder 70 can be positioned to avoid compression by the pressure surface 100 .

[0128] The pressing surface 100 can be pressed against the implant 10, and the implant 10 can be crimped onto the delivery apparatus 44. The delivery apparatus 44 can then be retracted proximally from the proximal opening 94, with the implant 10 crimped onto the apparatus 44. The stopper housing 200 can be disengaged distally from the crimping device 84, if desired. As shown in FIG. 23, the coupler 212 can be disengaged from the crimping device 84.

[0129] In particular, for example, proximal positioning device 172 shown in FIG. 19 can be removed from use if desired. Contact surface 224 of stopper housing 200 can define the axial position of delivery device 44 within channel 90, and thus positioning device 172 can be removed from use. However, in embodiments, proximal positioning device 172 can be utilized to suspend the shaft of delivery device 44 within channel 90.

[0130] The contours of the contact surface 224 may be defined based on the type of delivery device 44 utilized and the desired position of the delivery device 44 within the channel 90. For example, a narrower cavity 202 defined by the contact surface 224 may position the delivery device further proximally, while a wider cavity 202 may position the delivery device further distally as the delivery device 44 may pass further through the stopper housing 200. Other configurations of the contact surface 224 may be utilized as desired.

[0131] In embodiments, the stopper housing 200 may be used in conjunction with the embodiment shown in Figures 54-56. For example, the stopper housing 200 may be positioned distally of the crimping device 84 and the support 110 may be positioned proximally of the crimping device 84, as shown, for example, in Figure 55. The stopper housing 200 may be utilized to position the elongate shaft 46 at a desired location within the channel 90 and to position the implant 10 as desired relative to the implant holding area 54. The crimping procedure may then proceed as shown, for example, in Figure 56.

[0132] Variations of the stopper housing may be utilized. Figure 27, for example, illustrates a proximal perspective view of a stopper housing 230 including two separable bodies 232, 234 that can be separated to open a cavity 236. The stopper housing 200 shown in Figure 22 may be split to include separable bodies as well. Such a feature may allow the stopper housing to be assembled onto the distal tip of a delivery device to fix the position of the stopper housing on the delivery device.

[0133] The stopper housing 230 may further include a coupler 238 in the form of a spring-biased protrusion configured to spring outwardly for insertion into a retainer of the crimping device 84 and configured to retract to allow the stopper housing 230 to be removed from the crimping device 84. The stopper housing 230 may operate in a manner similar to the stopper housing 200 shown in FIG.

[0134] FIG. 28 illustrates a distal perspective view of an embodiment of a stopper housing 240 that includes two separable bodies 242, 244 surrounding an internal channel 246, similar to the stopper housing 230 shown in FIG. 27 . However, the stopper housing 240 may include a proximal portion 248 that extends into the channel 90 of the crimping device 84 and includes a plurality of compression arms 250 configured with pressing surfaces 100 applied thereto. The compression arms 250 may extend over the implant 10 and press against the implant 10 to crimp the implant 10 to the delivery apparatus 44. The compression arms 250 may thus function to assist in crimping the implant 10 to the delivery apparatus 44. The proximal portion 248 may, in embodiments, be separable from the bodies 242, 244.

[0135] The stopper housing may advantageously provide a reference or stop point to prevent distal axial movement of the delivery apparatus 44 and axially position the delivery apparatus 44 at a desired location within the crimping device 84. The delivery apparatus 44 may be positioned with the distal shoulder 70 distal to the pressing surface 100 and outside of the channel 90. In this manner, the distal shoulder 70 may be positioned to avoid compression by the pressing surface 100. In embodiments, the stopper housing may be selectively coupled to the crimping device 84 as desired.

[0136] The stopper housing embodiments may be utilized alone or in combination with other components disclosed herein. The configuration of the stopper housing may vary from the embodiments disclosed herein.

[0137] 29 illustrates an embodiment of a spacer body 260 according to an embodiment of the present disclosure. The spacer body 260 may be configured to extend over a portion of the delivery device 44 distal to the implant holding area 54 of the delivery device 44 and may include a contact surface 264 (marked in FIG. 30 ) for the distal end of the implant 10 to abut against to define the position of the implant 10 on the delivery device 44.

[0138] Spacer body 260 may include a proximal portion 262 and may include a distal portion 266. Spacer body 260 may include an outer surface 268 that may be configured to be gripped by a user. Proximal portion 262 may include multiple cavities, each having a different size.

[0139] 30, for example, illustrates a cross-sectional view of spacer body 260. Proximal portion 262 may include a proximal cavity 270 that may be sized to receive a crimped implant 10. Proximal portion 262 may further include a distal cavity 272 that may be sized to receive a portion of delivery device 44 distal to implant holding area 54, which may comprise the distal tip of delivery device 44. Cavity 272, in embodiments, may be configured to receive distal shoulder 70 of the delivery device. Contact surface 264 may be positioned between distal cavity 272 and proximal cavity 270 of proximal portion 262.

[0140] The proximal portion 262 may include an opening or window 274 (marked in FIG. 29) that may allow a user to see that the implant 10 is within the proximal cavity 270 and abutting the contact surface 264.

[0141] 30 , distal portion 266 may include a cavity 267 that comprises a continuation of distal cavity 272 of proximal portion 262. In embodiments, cavity 267 of proximal portion 262 may be sized to receive a portion of delivery device 44 distal to implant holding area 54, such as the distal tip of delivery device 44. Cavity 267 may be sized to prevent distal migration of the distal tip. Distal portion 266 may further include an opening or window 276 (marked in FIG. 29 ) that may allow a user to visualize the distal tip positioned within cavity 267 of distal portion 266.

[0142] 30 may comprise a first contact surface, and spacer body 260 may include a second contact surface 269 configured to abut a portion of a delivery device, such as the distal tip of delivery device 44. Second contact surface 269 may be contoured to impede distal movement of delivery device 44, for example, in a manner similar to contact surface 224 of stopper housing 200 shown in FIG. 24. Second contact surface 269 may be, for example, an interior surface of one or more of cavities 272, 267 and may be contoured to abut a distal portion of the delivery device, such as the distal tip.

[0143] The first contact surface 264 may be positioned outside and proximal to the cavities 272, 267 and may extend around the longitudinal axis of the spacer body 260. The first contact surface 264 may extend transversely to the longitudinal axis, or may extend perpendicularly as shown in FIG. 30. The first contact surface 264 may be positioned distal to the proximal face 278 of the spacer body 260, as shown in FIG. 30, or may comprise the proximal face of the spacer body, as shown in the embodiment of FIGS. 38 and 39, for example.

[0144] 31 , the delivery device 44, with the implant 10 positioned thereon in an uncrimped or partially crimped state, can be inserted distally into the proximal and distal cavities 270, 267 of the spacer body 260 until the delivery device 44 contacts the contact surfaces 269 of one or more of the cavities 272, 267 (marked in FIG. 30 ) and is therefore prevented from further distal movement. Thus, the position of the spacer body 260 on the delivery device 44 can be defined.

[0145] The implant 10 may then be advanced distally along the delivery device 44 in an uncrimped or partially crimped state until the implant 10 contacts the contact surface 264. The contact of the implant 10 with the contact surface 264 may define the position of the implant 10 on the delivery device 44. The implant 10 may then be positioned at a desired location on the delivery device 44. The delivery device 44 may remain in contact with the inner contact surface 269, and the implant 10 may remain in contact with the lateral contact surface 264 to maintain the desired position of the implant 10 on the delivery device 44.

[0146] A method of utilizing the spacer body 260 may include first placing the implant 10 within the crimping device 84. The implant 10 may be covered with a dampening body, such as Qualcrimp® or another form of dampening body. The implant 10 may be placed within the channel 90 of the crimping device 84 and may be partially crimped by the crimping device 84. In embodiments, the implant 10 may be positioned on the delivery apparatus 44, although in other embodiments, the implant 10 may not be positioned on the delivery apparatus during such a pre-crimping procedure.

[0147] The dampening body may be removed from the partially crimped implant 10. The partially crimped implant 10 may be crimped to a diameter that allows the implant 10 to fit within the proximal cavity 270 (marked in FIG. 30 ) of the spacer body 260. The spacer body 260 may then be positioned over the delivery device 44 by sliding it over the distal tip of the delivery device 44 with the distal tip within the cavities 272, 267 of the proximal and distal portions 262, 266, respectively. The spacer body 260 may be positioned over a portion of the delivery device 44 distal to the implant holding area 54 of the delivery device 44. FIG. 31 , for example, illustrates the delivery device 44 and implant 10 being inserted into the spacer body 260.

[0148] The distal tip can be inserted distally until it contacts the interior contact surface 269 of the cavity of the distal portion 266 (marked in FIG. 30 ). A user can visualize the distal tip in place through a window 276 in the distal portion 266. FIG. 32 , for example, illustrates the distal tip in place and visible through the window 276 in the distal portion 266. Thus, a user can confirm that the delivery device 44 is in a desired position relative to the spacer body 260.

[0149] The partially crimped implant 10 can be inserted distally into the proximal cavity 270 until the distal end of the implant 10 abuts the contact surface 264. The abutment of the distal end against the contact surface 264 defines the location of the implant 10 on the delivery device 44. FIG. 33 , for example, illustrates the implant 10 in contact with the contact surface 264 and within the proximal cavity 270. With the spacer body 260 in a defined position on the delivery device 44, the partially crimped implant 10 can be similarly positioned in a defined position. The defined position can be a desired location on the implant-retaining area of ​​the delivery device 44. In embodiments, the defined position can be on a marker band or other imaging marker on the delivery device 44 that defines the desired location of the implant 10.

[0150] With the implant 10 in place abutting the contact surface 264, the spacer body 260 and delivery apparatus 44 may be inserted distally through the proximal opening 94 of the crimping device 84, as shown in FIG. 6 , with the implant 10 remaining in contact with the contact surface 264. The spacer body 260, delivery apparatus 44, and implant 10 may continue to pass distally through the channel 90 of the crimping device 84 until the spacer body 260 is positioned distal to the pressing surface 100. FIG. 34, for example, illustrates the spacer body 260 positioned distal to the pressing surface 100 and in the distal opening of the crimping device 84.

[0151] The proximal portion of the spacer body 260 may be held against the distal surface 277 of the body, which comprises the pressure surface 100. The delivery device 44 and implant 10 may remain in a fixed position relative to the spacer body 260 and thus be held in a defined relationship relative to the pressure surface 100.

[0152] With the implant 10 in place in the channel 90, the pressure surface 100 can fully or partially crimp the implant 10. The spacer body 260 can then be removed distally from the delivery device 44. The portion of the implant 10 covered by the spacer body 260 can then be crimped onto the delivery device 44 to complete the crimping procedure.

[0153] Variations of the spacer body 260 may be utilized. Figure 35, for example, illustrates a distal perspective view of a spacer body 280 in which the distal portion 282 has a cylindrical shape. The proximal portion 284 may include multiple cavities 286, 288 (marked in Figure 37) having different sizes, and the distal portion 282 may include a cavity 290 that is smaller in size than the cavity 288.

[0154] The proximal portion 284 may include an opening or window 292 that may be utilized to visualize the contact of the implant 10 on a contact surface 294. The distal portion 282 may further include an opening or window 296 for viewing the distal tip of the delivery device 44 within the cavity 290 and its abutment with the contact surface 295 of the cavity 290.

[0155] The proximal portion 284 may further include a flange 298 that may extend radially outward from the proximal portion 284. The flange 298 may be utilized to grip the proximal portion 284 and to position the proximal portion within an opening in the distal face of the crimping device 84, for example, as shown in FIG.

[0156] Figure 36 illustrates a distal perspective view of spacer body 280. Figure 37 illustrates a side cross-sectional view of spacer body 280. A contact surface 294 for contacting the distal end of implant 10 is shown. A contact surface 295 for contacting the distal tip of delivery device 44 is also shown.

[0157] Spacer body 280 may operate in a similar manner to spacer body 260 shown in FIG.

[0158] FIG. 38 illustrates an embodiment of a spacer body 300 in which a proximal portion 302 of the spacer body 300 lacks a housing for extending over the implant 10, similar to the housing 261 shown in FIG. 29 . FIG. 39 illustrates a cross-sectional view of the spacer body 300 shown in FIG. 38 . The implant 10 may abut against the contact surface 304 of the spacer body 300 in a manner similar to how the implant 10 abuts against the contact surface 264 shown in FIG. 30 . The spacer body 300 may include a cavity 303 configured to receive a distal portion of a delivery device and may include an inner contact surface 305 for abutting against the distal portion of the delivery device. In the embodiment shown in FIG. 38 , the implant 10 may be fully crimped onto the delivery device 44 by the crimping device 84 without the spacer body 300 being removed from the distal tip of the delivery device 44. The spacer body 300 may then be removed from the distal tip after the implant 10 is fully crimped.

[0159] 40 illustrates an embodiment of a spacer body 310 that may be configured similarly to spacer body 300, but may further include a balloon cover 312 extending proximally from spacer body 310. Balloon cover 312 may comprise an elongate body configured to extend over balloon 58 (marked in FIG. 5) to prevent damage to balloon 58. Coupler 314 may connect balloon cover 312 to spacer body 310 and may be configured to be separable from spacer body 310. For example, coupler 314 may comprise a jaw or another form of coupler that joins balloon cover 312 to spacer body 310.

[0160] 41 illustrates a cross-sectional view of the balloon cover 312 in place over the balloon 58. The balloon cover 312 may include an interior cavity 313 that may be formed to follow the shape of the balloon 58, particularly the shape of the proximal shoulder 78 of the balloon 58. The balloon cover 312 may include a proximal opening 316 configured to allow the delivery device 44 to pass therethrough.

[0161] In operation, the spacer body 310 and balloon cover 312 may be packaged on the delivery device 44 with the balloon cover 312 extending over the balloon 58. The balloon cover 312 may protect the balloon 58. At the desired time to crimp the implant 10 against the balloon 58, the balloon cover 312 may be separated from the spacer body 310 and discarded. The implant 10 may then be pressed against the contact surface 318 of the spacer body 310 to position the implant 10 in the desired position relative to the implant holding area 54 of the delivery device 44.

[0162] The configuration of the spacer body may vary in embodiments as desired. Spacer body embodiments may be utilized alone or in combination with other components disclosed herein.

[0163] 42 illustrates an elongate body 320 according to an embodiment of the present disclosure. The elongate body 320 may include a channel 322 for receiving the elongate shaft 46 of the delivery device 44. The delivery device 44 may include a proximal portion including a handle 52 and a distal portion including an implant holding area 54. The elongate body 320 may be configured to bend in at least one plane to move the distal portion of the delivery device 44 adjacent to the proximal portion of the delivery device 44.

[0164] The elongated body 320 may include a proximal end 324 and a distal end 329, and a length between the ends 324, 329. The elongated body 320 may comprise a sleeve configured to extend along the elongated shaft 46. The elongated body 320 may have walls forming a "U" shape that extends around the channel 322, which may extend along the length of the elongated body 320.

[0165] The elongate body 320 can be configured to be in a straight configuration and be bent in a plane from the straight configuration to a bent or curved configuration. The elongate body 320 can be bent to bring the ends 324, 329 toward and toward one another. FIG. 44, for example, illustrates the ends 324, 329 brought toward one another. The elongate body 320 in such a bent configuration can form a "U" shape.

[0166] The elongated body 320 may include a plurality of cutout portions 326 positioned on a side 327 of the elongated body 320. The cutout portions 326 may be positioned on a side of the elongated body 320 that form an inner curve when the elongated body 320 is bent. The elongated body 320 may be bent such that the cutout portions 326 close to form the inner curve of the elongated body 320.

[0167] The cutout portions 326 may be shaped to define the shape of the elongate body 320 in the bent configuration. For example, each cutout portion 326 may have a wedge shape, with the angle of the opposing surfaces 328 set to define the amount the elongate body 320 can be bent. Multiple cutout portions 326 may be configured such that the opposing surfaces 328 (marked in FIG. 43 ) of the cutout portions 326 are configured to retract toward each other and may contact each other when the elongate body 320 is bent. The opposing surfaces 328 may, for example, contact each other to define the radius of curvature of the elongate body 320 in the bent configuration.

[0168] 42 , the cutout portion 326 may be positioned opposite a side 330 of the elongate body 320 that includes an elongate opening 332 that forms a “U” shaped opening in the elongate body 320. The elongate shaft 46 may be inserted into the elongate body 320 by being inserted through the elongate opening 332.

[0169] The elongate body 320 may include one or more couplers 334 that may be configured to hold the elongate body 320 in a bent configuration and may couple the ends 324, 329 of the elongate body 320 together when the elongate body 320 is in the bent configuration. The couplers 334 may be in the form of a tether having an opening 335 at the end of the tether configured to couple to a pin 339 or other device positioned at the proximal end 324 of the elongate body 320. The tether may maintain the distance between the proximal end 324 and the distal end 329 of the elongate body 320 when the elongate body 320 is in the bent configuration.

[0170] Figure 43 illustrates a side view of elongate body 320. Figure 44 illustrates a perspective view of elongate body 320 in a bent configuration. Cutout portion 326 is closed to allow elongate body 320 to move into the bent configuration. Coupler 334 may extend from distal end 329 to proximal end 324 and may be sufficiently rigid to hold elongate body 320 in the bent configuration.

[0171] In the bent configuration, the elongated opening 332 extending along the side 330 of the elongated body 320 may form an outward curve and may close slightly to further enclose the delivery device 44 positioned within the channel 322. FIG. 45 , for example, illustrates the elongated shaft 46 positioned within the channel 322 of the elongated body 320, with the size of the opening 332 reduced to slightly close the opening 332 when the body 320 is in the bent configuration. The edges 336, 338 of the walls of the elongated body 320 are drawn toward each other to reduce the size of the opening 332. In this manner, the walls may function to retain the elongated shaft 46 of the delivery device 44 within the channel 322.

[0172] Other methods and devices may be utilized to retain the delivery device 44 within the channel 322. FIG. 46 illustrates an embodiment in which, for example, a coupler 340 that pivots relative to the elongated opening 332 may be utilized. The coupler 340 may be a pivoting coupler configured to pivot open and closed to allow the delivery device 44 to be inserted into and retained within the channel 322. The coupler 340 may comprise, for example, a lever arm pivotally coupled to a wall of the elongated body 320. Multiple couplers 340 may be utilized along the length of the elongated opening 332 as desired.

[0173] 47 illustrates an embodiment in which a coupler 342 in the form of a strap may be utilized to hold the delivery device 44 to the elongated body 320. The strap may extend over the elongated opening 332 and may be configured to release and secure a pin 344 or other coupler that may hold the coupler 342 in a fixed position. The coupler 342 may extend over the elongated shaft 46 of the delivery device 44 to hold the delivery device 44 to the elongated body 320.

[0174] 52 illustrates an embodiment in which a coupler in the form of a resilient retainer 331 may be utilized to retain the delivery device 44 to the elongate body 320. The resilient retainer 331 may be overmolded or otherwise positioned on the elongate body 320. One or more retainers 331 may be utilized, such as a retainer at the proximal end 324, the distal end 329, and / or at one or more intermediate locations of the elongate body 320 between the proximal end 324 and the distal end 329. For example, as shown, four retainers 331 may be utilized, one at the proximal end 324, one at the distal end 329, and two positioned between the notched portions of the elongate body 320. In embodiments, only one retainer 331 may be utilized, or multiple retainers may be utilized as desired.

[0175] FIG. 53 illustrates a cross-sectional view of the elongated body 320 shown in FIG. 52 taken along line 53-53. A resilient retainer 331 may extend around the elongated body 320 and cover the inner and outer surfaces of the elongated body 320. The retainer 331 may be overmolded onto the elongated body 320 to cover the inner and outer surfaces of the elongated body 320. The retainer 331 may have two ends 333 positioned in the elongated opening 332 of the elongated body 320. Thus, the elongated shaft 46 may be inserted into the elongated body 320 through the opening 332. The ends 333 of the retainer 331 may bend outward to allow the elongated shaft 46 to be inserted into the channel of the elongated body 320. The ends 333 may then bend inward toward the elongated shaft 46 to grip the elongated shaft 46 within the channel. Ends 333 may form arms that overlap a portion of elongate shaft 46 to retain elongate shaft 46 with the channel in elongate body 320. Ends 333 of retainer 331 may be spaced apart from one another, as shown in FIG. 53, or may contact one another in some embodiments.

[0176] To remove the elongated shaft 46 from the resilient retainer 331, the elongated shaft 46 can be pulled out of the elongated opening 332. The end 333 can bend outward to allow the elongated shaft 46 to exit the channel in the elongated body 320. The other retainers 331 utilized in the elongated body 320 can each be similarly configured and operate in a similar manner.

[0177] The retainer 331 may be flexible to allow the end 333 to flex outward and inward. The retainer 331 may be further flexible to allow the retainer 331 to buffer the elongate shaft 46 from forces that may be applied to the elongate body 320. The retainer 331 may be made of a resilient material that may be configured to return to its original shape upon deformation. The material of the retainer 331 may be a rubber material, or in embodiments, various resilient polymers, or other materials as desired. One or more retainers 331 may be configured to be overmolded onto one or more desired portions of the elongate body 320, such as the ends 324, 329, or an intermediate portion of the elongate body 320. The configuration of the retainer 331 may be varied from the configuration shown in FIGS. 52 and 53 of the embodiment.

[0178] Other devices and methods may be utilized to couple delivery apparatus 44 to elongate body 320 as desired.

[0179] In operation, the elongate body 320 may be coupled to the delivery device 44 and packaged when the delivery device 44 is provided to a user who may prepare or otherwise utilize the delivery device 44. FIG. 48 , for example, illustrates the elongate body 320 coupled to the delivery device 44, with the elongate shaft 46 positioned within the channel 322 of the elongate body 320. The elongate body 320 is in a straight configuration, and the elongate shaft 46 is also in a straight configuration. The delivery device 44 may be provided to a user with the elongate body 320 positioned thereon, with both in the straight configuration.

[0180] It may be desirable for a user to position the distal tip of the elongate shaft 46 and the implant holding area 54 proximate the handle 52 and control mechanism of the delivery device 44. Such a feature may be beneficial, for example, when a user desires to perform an operation at the distal end of the delivery device 44 while controlling the control mechanism. For example, if a crimping operation is performed at the distal end of the delivery device 44, the user may desire to control the position of the outer sheath 64, shown in FIG. 5, to cover or not cover the front or portion of the balloon 58 or implant 10. The user may, in embodiments, otherwise desire to have the proximal end of the delivery device 44 proximate the distal end of the delivery device 44.

[0181] The elongated body 320 can be utilized to assist a user in bending the elongated shaft 46 so that the distal end of the delivery device 44 is proximal to the proximal end of the delivery device 44. The user can grasp the distal end 329 and / or the proximal end 324 of the elongated body 320 and draw the ends 324, 329 together. The elongated body 320 can be bent in at least one plane to bend the elongated shaft of the delivery device so that the distal portion of the delivery device is positioned proximal to the proximal portion of the delivery device. The elongated body 320 can be moved from the straight configuration shown in FIG. 48 to the bent or curved configuration shown in FIG. 49. The cutout portion 326 can be reduced in size so that the opposing surfaces 328 contact each other. The elongated opening 332 (marked in FIG. 45) can be fully or partially closed to enclose the elongated shaft 46 within the channel 322. In embodiments, other devices or methods may be utilized to couple elongate shaft 46 to elongate body 320, such as the coupler shown in FIG. 46 or FIG. 47, among other forms of couplers.

[0182] The elongate body 320 may be held in a bent or curved configuration by couplers 334 extending between the ends 324, 329 of the elongate body 320. One or more couplers may be engaged between portions of the elongate body 320 to maintain the bent configuration of the elongate body 320. The couplers 334 may hold the elongate body 320 and the elongate shaft 46 in a bent or curved configuration.

[0183] In the bent or curved configuration, a user may be able to view the distal end of the delivery apparatus 44 while also manually operating the control mechanism with the handle 52. The proximity of the handle 52 to the distal end may allow for easy manipulation at the distal end. A crimping operation, or other manipulation, may be performed at the distal end. For example, the distal end of the delivery apparatus 44 may be inserted into the channel 90 of the crimping device 84, and the implant 10 may be crimped into the implant holding area 54. The crimping procedure may include the crimping procedures disclosed herein or another form of crimping procedure.

[0184] With the desired manipulation performed on the distal end of delivery device 44, delivery device 44 can be released from elongate body 320. For example, coupler 334 can be released and elongate shaft 46 can be straightened. Elongate shaft 46 can then be removed from channel 322 of elongate body 320. Delivery device 44 can then be prepared for insertion into a portion of a patient's body or can have another manipulation performed on delivery device 44.

[0185] The elongated body 320 can advantageously allow the ends of the delivery device 44 to be efficiently adjacent to one another. The ends may be closely spaced to allow more efficient manipulation to be performed at the ends of the delivery device. The elongated body 320 can be provided packaged on the elongated shaft 46 of the delivery device 44 to allow for easy packaging and delivery to the user. The elongated body 320 can be separated and discarded after use.

[0186] FIG. 50 illustrates a variation of the elongate body 346 in which the couplers configured to hold the elongate body 346 in a bent configuration may include multiple couplers in the form of pins 352 configured to engage with apertures 354. The pins 352 may be coupled to one side of the notched portion 356 and the apertures 354 may be coupled to another side. The pins 352 may be configured to engage with the apertures 354 in a ratchet-like manner, where the pins 352 include barbs or other structure configured to allow the pins 352 to engage with the apertures 354. When the elongate body 346 is moved to a bent or curved configuration, as shown in FIG. 51 , the pins 352 may engage with the apertures 354 to hold the elongate body 346 in the bent or curved configuration. Other configurations of couplers may be utilized as desired.

[0187] The elongate bodies may be utilized alone or in combination with other components disclosed herein. The configuration of the elongate bodies may vary in the embodiments.

[0188] 57 illustrates a side view of a crimping system that may be utilized in embodiments herein. The crimping system may be for an artificial implant. The crimping system may utilize a crimping device 400 to crimp an implant according to embodiments herein.

[0189] The crimping device 400 may include a plurality of elongated strands 402, each having a first end 404 (shown in cross section in FIG. 58 ) and a second end 406 (shown in cross section in FIG. 58 ). Referring to the cross section in FIG. 58 , the plurality of elongated strands 402 (with exemplary strands 402 a, b marked in FIG. 58 ) may be arranged to form an elongated tube 408 extending about an axis 410, surrounding a channel 412 configured to receive an implant, and having a central portion 414 with an inner diameter 416.

[0190] In embodiments, crimping device 400 may include a first support 417 that may be coupled to a first end 404 of each of the plurality of elongate strands 402. Crimping device 400 may include a second support 419 that may be coupled to a second end 406 of each of the plurality of elongate strands 402 and may be configured to rotate about an axis 410 relative to first support 417 to reduce inner diameter 416 and compress the prosthetic implant within channel 412.

[0191] 57, the elongate strands 402 may comprise string-like or wire-like bodies, each having a length greater than the diameter of the respective strand 402. The strands 402 may have a circular cross-section, or may be provided as flat strips, or may have another configuration as desired.

[0192] Each of the strands 402 may be configured to be flexible in embodiments and, in certain embodiments, may be configured to stretch longitudinally. In embodiments, the strands 402 may be configured to stretch longitudinally, allowing rotation of the ends of the strands 402 relative to one another. The degree of stretch may be at least 5%, 7%, 10%, or greater or lesser degrees of stretch in embodiments, as desired. The elongate strands 402 may each comprise a single strand body or a multi-strand body that may be configured to bend.

[0193] Elongated strands 402 may be made of a polymeric material (such as nylon or other forms of polymer) or may be made of a metal (such as stainless steel or nitinol or other metals as desired). Elongated strands 402 may be textured or provided with a frictional coating to improve grip on the implant in embodiments. In embodiments, elongated strands 402 may be coated with a lubricious coating, for example, to minimize potential damage to the implant and improve the ability of portions of a delivery device, such as a sheath, to contact and slide against strands 402. In embodiments, other forms of elongated strands 402 may be utilized.

[0194] The plurality of elongate strands 402 may be arranged to form an elongate tube 408 with the plurality of elongate strands 402 spaced circumferentially apart from one another, as shown in Figures 57 and 59. For example, the first ends 404 of the elongate strands 402 may each be coupled to a first support 417 (as shown in Figure 59) at circumferential intervals from one another. The first ends 404 may be arranged in a ring. The spacing may be the same between the ends 404 of the elongate strands 402, or in embodiments, the spacing may vary. The second ends 406 of the elongate strands 402 may each be coupled to a second support 419 at the opposite end of the elongate strand 402, in a manner similar to that shown in Figure 59. The second ends 406 may be arranged in a ring.

[0195] The arrangement of the respective ends 404, 406 of the elongate strands 402 may form an elongate tube 408 between the ends 404, 406. The elongate tube 408 may have a cylindrical configuration, as shown in Figures 57 and 59, for example, or in embodiments may have another configuration, such as a rectangular or triangular configuration.

[0196] The number of elongate strands 402 may vary in embodiments. As shown in Figures 57 and 59, the number of elongate strands may be 36, although greater or fewer numbers may be utilized in embodiments. For example, the number of elongate strands may be 10 or more, 20 or more, 30 or more, or a greater or lesser amount, as desired. The number of elongate strands may be greater than 50 in embodiments.

[0197] 58 , first ends 404 of the plurality of elongate strands 402 may be arranged to form openings 420 for channels 412. Second ends 406 of the plurality of elongate strands 402 in embodiments may further be arranged to form openings 422 for channels 412. One or more of openings 420, 422 may allow an object, such as an artificial implant, to pass through and into channel 412 for crimping.

[0198] The first end 404 of the plurality of elongate strands 402 may further be arranged to have a diameter 424. The diameter 424 may comprise the diameter of the opening 420 in embodiments. The second end 406 of the plurality of elongate strands 402 may further be arranged to have a diameter 426. The diameter 426 may comprise the diameter of the opening 422 in embodiments. One or more of the diameters 424, 426 in embodiments may be configured to be less than the length 427 of the elongate tube 408. In this manner, the elongate strands 402 may form an elongate structure that may be configured to accommodate an elongate implant and provide the ability for an elongate sheath (shown in FIG. 65 ) to enter the channel 412 and capture the crimped implant. The ratio of the diameters 424, 426 to the length 427 of the elongate tube 408 may provide improved crimping and capture of the crimped implant during the crimping process. The relative proportions of the elongate tube 408 may be varied in embodiments from those shown herein.

[0199] The supports 417, 419 may be positioned at the ends 404, 406 of the plurality of elongate strands 402. One or more of the supports 417, 419 may include respective openings 428, 430 that may connect to respective openings 420, 422 in the plurality of elongate strands 402. In embodiments, the supports 417, 419 may have various configurations, including ring bodies as shown in FIGS. 57-60 , or other configurations such as lever arms or mechanical actuators, or other configurations as desired. The supports 417, 419 may include respective gripping portions 432, 434 that may allow for gripping of the supports 417, 419 during use. The gripping portions 432, 434 may be gripped to allow for rotation of the supports 417, 419 relative to one another as desired. Gripping may include manual gripping in embodiments. For example, a user may grasp one or more of the gripping portions 432, 434 and rotate one or more of the supports 417, 419 relative to one another. In an embodiment, the gripping may be provided by a tool.

[0200] In embodiments, the retainer body 436 may be coupled to the first support 417 and the second support 419. The retainer body 436 may comprise a central body positioned between the first support 417 and the second support 419. The retainer body 436 may define a distance between the first support 417 and the second support 419 (corresponding to the length 427 shown in FIG. 58 ). The retainer body 436 may comprise a housing that holds the components of the crimping device 400 together. The retainer body 436 may include a plurality of openings, as shown in FIGS. 57 and 59 , that may allow for viewing of the interior of the retainer body 436.

[0201] Retainer body 436 may have a first portion 438 coupled to first support 417 and a second portion 440 coupled to second support 419. In embodiments, retainer body 436 may comprise a tube having an interior cavity for holding multiple elongated strands 402 therein, or may have another configuration as desired.

[0202] In embodiments, the retainer body 436 may define a static distance between the first support 417 and the second support 419. For example, as shown in FIGS. 57-59, the retainer body 436 may be rigid and thus may maintain the relative position of the first support 417 and the second support 419. In embodiments such as shown in FIG. 66, the retainer body may have a varying length to provide a variable distance between the first support and the second support.

[0203] One or more of the first support 417 or the second support 419 may be configured to rotate relative to the retainer body 436. For example, as shown in FIG. 58 , the first support 417 and the second support 419 may be coupled to the retainer body 436 by respective rotational couplers 442, 444, which may enable rotation about the axis 410. For example, each rotational coupler 442, 444 may include a bearing surface that enables rotation. The retainer body 436, in embodiments, may maintain a distance between the first support 417 and the second support 419 during rotation. In embodiments, one of the first support 417 or the second support 419 may be configured to rotate relative to the retainer body 436 while the other support remains fixed in position relative to the retainer body 436. Thus, a user may rotate only one of the supports 417, 419 in such embodiments. Various other configurations of the retainer body may be utilized as desired.

[0204] The plurality of elongate strands 402 may be configured to rotate from an expanded configuration to a reduced-diameter configuration. The expanded configuration may be shown in FIGS. 57-62. In the expanded configuration, the channel 412 may be available for an implant to be inserted therein. As shown in FIGS. 57-60, in the expanded configuration, each of the first ends 404 of the elongate strands 402 may be circumferentially aligned with a respective one of the second ends 406 of the elongate strands 402. FIG. 59, for example, illustrates such an arrangement. The elongate strands 402 may extend parallel to an axis 410. FIG. 60 includes a cross-sectional view of the crimping device 400 taken along line AA in FIG. 57. The elongate strands 402 are shown extending parallel to the axis 410.

[0205] 58 , in the expanded configuration, the inner diameter 416 of the central portion 414 of the elongate tube 408 may be at its largest. The inner diameter 416 of the central portion 414 may be the same as the diameters 424, 426 of the ends 404, 406 of the strands 402. In embodiments, the expanded configuration may include some rotation of the first ends 404 of the elongate strands 402 relative to the second ends 406. For example, FIG. 61 illustrates an expanded configuration with some rotation of the first ends 404 of the elongate strands 402 relative to the second ends 406.

[0206] In the expanded configuration, an implant can be inserted into channel 412. Figure 61, for example, illustrates implant 450 positioned within channel 412 (the frame of implant 450 shown and other features of implant 450 are omitted from the figure for clarity). Implant 450 can preferably be positioned in central portion 414 of elongated tube 408.

[0207] FIG. 62 illustrates a cross-sectional view of an implant 450 positioned within a channel 412. The implant 450 may be axially aligned within the channel 412 as shown in FIGS. 61 and 62 . In embodiments, the implant 450 may be inserted into the channel 412 through one of the openings 420, 422 in the plurality of elongate strands 402 and through one of the openings 428, 430 in the supports 417, 419. In embodiments in which the implant 450 is to be positioned on a portion of a delivery device, such as a balloon-expandable implant, the portion of the delivery device may extend through the channel 412 from one opening 422 to another opening 420, as desired. Thus, the openings 420, 422 in the channel 412 may allow the elongate shaft of a delivery device to pass therethrough, if desired, as may be disclosed herein. The elongate shaft of the delivery device is excluded from the views of FIGS. 61 and 62 .

[0208] 61 and 62 , one or more of the supports 417, 419 can be rotated relative to one another to rotate the plurality of elongate strands 402. The second support 419 can be rotated about axis 410 relative to the first support 417 to reduce the inner diameter 416 and compress the implant 450 within the channel 412. The plurality of elongate strands 402 can be rotated into a reduced diameter configuration. The ends 404, 406 of the plurality of elongate strands 402 can be rotated relative to one another. The plurality of elongate strands 402 can be twisted into a reduced diameter configuration.

[0209] 63 and 64, for example, illustrate the plurality of elongate strands 402 in a reduced diameter configuration. The plurality of elongate strands 402 and elongate tube 408 form a bipolar or hourglass shape with a reduced inner diameter 416, with respective diameters 424 at first end 404 and 426 at second end 406 being larger than inner diameter 416.

[0210] Each of the plurality of elongate strands 402 may have a circumferential position of the first end 404 that rotates relative to the second end 406, causing each strand to rotate about an axis 410 and extend transversely relative to the axis 410. The strands 402 may each extend longitudinally to allow the circumferential position of the first end 404 to rotate relative to the second end 406, considering that the length 427 of the elongate tube 408 remains constant, as shown in FIG.

[0211] 64 illustrates a schematic cross-sectional view of the crimping device 400, without illustrating the profile of the strands 402 and the individual strands. As shown in FIG. 64 , the plurality of elongated strands 402 can form a first funnel 452 extending radially outward from the central portion 414 toward the first end 404 of the plurality of elongated strands 402 when the plurality of elongated strands 402 is in the reduced diameter configuration. The plurality of elongated strands 402 can form a second funnel 454 extending radially outward from the central portion 414 toward the second end 406 of the plurality of elongated strands 402 when the plurality of elongated strands 402 is in the reduced diameter configuration. Each funnel can have a frustoconical shape with a wide portion directed away from the central portion 414 of the elongated tube 408 and the narrow portion of the central portion 414. Other configurations of the funnels can result as desired.

[0212] The central portion 414 may apply a compressive force to the implant 450 due to the plurality of elongated strands 402 contacting the implant 450 and pressing radially inward against the implant 450. In response, the central portion 414 may crimp the implant 450. The central portion 414 may have a cylindrical shape positioned between funnels 452, 454 created by the implant 450 deflecting the elongated strands 402 at the central portion 414.

[0213] In embodiments, implant 450 may be configured to elongate and axially lengthen in response to a radial compressive force applied to implant 450 by multiple elongate strands 402. The diameter of the implant may, for example, decrease with a corresponding increase in the length of the implant. For example, the length of implant 450 shown in FIGS. 63 and 64 has been increased. In embodiments, ends 460, 462 of implant 450 may remain within channel 412 and be positioned within respective leak conduits 452, 454.

[0214] In embodiments, implant 450 can be crimped onto the elongate shaft of a delivery device in the configuration shown in FIG. 64. For example, the elongate shaft of a delivery device can be passed through channel 412 and the implant can be crimped onto the elongate shaft (e.g., a balloon-expandable implant can be crimped onto an inflatable balloon). The implant 450 can be crimped onto an implant-retaining area of ​​the elongate shaft. However, in embodiments, in the configuration shown in FIG. 64, a portion of the delivery device can be inserted into channel 412 to couple to and extend over the crimped implant 450.

[0215] 65 illustrates, for example, that a sheath 461 of a delivery device can be inserted into channel 412 and passed over the compressed implant 450 within channel 412. In embodiments, sheath 461 can include a capsule for holding implant 450 prior to deployment of implant 450. The capsule can, for example, cover implant 450 during delivery of implant 450 and can include an implant holding area of ​​the delivery device. In embodiments, other forms of sheaths can be utilized to capture the implant, such as a loader for loading an implant into a delivery device or other device.

[0216] The plurality of elongate strands 402 may extend radially outward from the central portion 414 when the plurality of elongate strands is in the reduced diameter configuration and the sheath passes over the implant 450 (as marked by the arrows pointing radially outward in FIG. 65 ). The strands 402 may extend radially outward from the central portion 414 when the plurality of elongate strands is in the reduced diameter configuration, allowing the sheath 461 to extend over the outer surface of the implant 450. The sheath 461 may contact the strands 402 and press the strands 402 radially outward. The sheath 461 may slide between the strands 402 and the outer surface of the implant 450.

[0217] Sheath 461 may extend over crimped implant 450 to capture implant 450, and then be removed and retracted from channel 412 with implant 450 positioned therein. In this manner, implant 450 may be captured with sheath 461 in a crimped state in a single crimping operation. Other features of the delivery device, such as a guidewire shaft or nosecone, may pass through channel 412 and, in embodiments, may exit opening 422, if desired.

[0218] A funnel 452 formed by the plurality of elongate strands 402 can be configured to receive a sheath 461 of a delivery device for extending over the prosthetic implant. The funnel 452 can guide the sheath 461 to capture the implant 450. For example, the funnel 452 can deflect and orient the sheath 461 toward the implant 450 to improve capture of the crimped implant 450.

[0219] In embodiments, the implant 450 may include a mechanical frame that may have multiple struts connected by rotatable hinges. The implant 450 may include a mechanically expandable implant. For example, FIGS. 68A-68C illustrate exemplary configurations of implants with mechanical frames. Implants with mechanical frames may expand due to manipulation of the mechanical assembly. Examples of such implants are disclosed in U.S. Patent No. 9,913,716, filed January 24, 2017, and issued March 13, 2018, which is incorporated herein in its entirety. Figures 72, 77, and 81 of U.S. Patent No. 9,913,716 are reproduced herein as FIGS. 68A-68C. The implant may include a prosthetic replacement heart valve assembly 572, a stent lattice 574, a graft enclosure 576, a jack assembly 578, graft material 580, valve leaflets 582, and a commissure plate 584. The frame may include multiple struts. The cover has been removed in FIG. 68B to show the plurality of struts 586. The plurality of struts 586 may be connected by a rotatable hinge. FIG. 68C illustrates the implant in a compressed state with the cover removed. A crimping device as disclosed herein may be utilized to move the implant into the compressed state as shown in FIG. 68C. A mechanical assembly may then be utilized to expand the implant at the desired location within the patient's body.

[0220] The use of a mechanical frame may allow the entire frame to crimp due to compression of a single portion or an intermediate portion of the implant. For example, referring to FIG. 64 , end portions 460, 462 of implant 450 may protrude from central portion 414 and may be in compression due to central portion 464 being compressed by multiple elongated strands 402. As such, a compressive force need only be applied to a portion of implant 450 to create a crimped state for the entire implant 450. The protruding end portions 460, 462 of implant 450 may allow for easy capture by a portion of a delivery device, such as sheath 461 shown in FIG. 65 . The implant 450 may be configured to have a length that increases in response to radial compression of implant 450.

[0221] In embodiments, other forms of implants may be utilized and crimped, including self-expandable implants, balloon-expandable implants, and other forms of expandable implants. Implants crimped with crimping device 400 may include implants that can be biased to expand when the compressive force of the crimping device is released. For example, mechanically expandable implants may expand when the compressive force is released, which can make capturing such implants in the sheath of a delivery device difficult. Therefore, these implants may beneficially remain in a compressed state when the sheath captures them, as shown, for example, in FIG. 65 . Compressive force on the implant may remain during capture, reducing the likelihood of the implant expanding radially outward. A simplified crimping and capture process may result. In embodiments, other forms of implants may be utilized with the embodiments herein. The utilized implants may be for deployment in the aortic, mitral, tricuspid, or pulmonary valves, among other deployment sites. The implant, in embodiments, may include a replacement heart valve. The implant may include leaflets and other components, such as one or more skirts, as disclosed herein. Other forms of implants may be utilized as desired.

[0222] In embodiments, an insert may be utilized that may have a mechanical frame similar to the frame of implant 450. The insert may include, for example, multiple struts connected by a rotatable hinge. The insert may be configured to crimp due to compression of a single portion or a central portion of the insert. The insert may be configured to receive a prosthetic implant within the insert. The implant may include, for example, a self-expandable or balloon-expandable implant, which may have a plastically deformable frame. The insert may have an implant positioned therein. The insert with the implant positioned therein may be positioned within channel 412 and crimped with crimping device 400. In this manner, a central force applied to a single portion of the insert by crimping device 400 may result in the entire insert being crimped. The insert may radially compress the implant, thus crimping the entire implant along its length.

[0223] Variations of the crimping device 400 may be provided. FIG. 66, for example, illustrates an embodiment in which a retainer body 470 is configured to have a length 472 that varies to provide a variable distance between the first support 417 and the second support 419. The retainer body 470 may include a variable length body, such as a piston 474 and / or a spring 476, to allow the length 472 to vary. The plurality of elongated strands 480 in such an embodiment may have a fixed length or may be non-stretchable. The distance between the supports 417, 419 may vary to allow the plurality of elongated strands 480 to rotate upon relative rotation of the supports 417, 419. Other forms of variable length bodies or combinations of variable length bodies may be utilized as desired.

[0224] 67 illustrates an embodiment in which a variable length body comprises a portion of elongate strand 490. The variable length body may comprise a body such as a piston 492 or spring 494 to allow the length of elongate strand 490 to change. Thus, a first portion of the elongate strand may be elastic and a second portion may be non-elastic in such embodiments. The length of retainer body 436 may be maintained constant.

[0225] In embodiments, during manufacturing, the elongated strands may be formed and coupled to the support in separate steps. In embodiments, the elongated strands may be integrally formed with the first support and / or the second support. For example, the support and the elongated strands may be formed in a mold, such as a single mold, and may be integral with one another. Injection molding may be utilized, which may result in reduced manufacturing complexity. Various other manufacturing methods may be utilized as desired.

[0226] The crimping systems and devices disclosed herein may be utilized alone or in combination with other embodiments disclosed herein.

[0227] The crimped or otherwise prepared implants and devices may be utilized in treatment of a portion of a patient's body, which may include, among other procedures, implantation of the implant.

[0228] As discussed, various forms of implants may be utilized with the embodiments disclosed herein, including, among other things, prosthetic heart valves or other forms of implants such as stents or filters or diagnostic devices. The implant may be an expandable implant configured to move from a compressed or undeployed state to an expanded or deployed state. The implant may be a compressible implant having a reduced outer profile and configured to be compressed inward to move the implant to the compressed or undeployed state. The crimping devices disclosed herein may assist in moving the implant to the compressed or undeployed state.

[0229] Delivery devices as disclosed herein may similarly be utilized for replacement and repair of the aorta, aortic valve, tricuspid valve, and lungs. The delivery devices may include, among other things, delivery devices for the delivery of stents or filters, or other forms of implants, such as diagnostic devices.

[0230] The delivery devices and systems disclosed herein may be used for transcatheter aortic valve implantation (TAVI) or replacement of other native heart valves (e.g., mitral, tricuspid, or pulmonary). The delivery devices and systems disclosed herein may be utilized for transarterial access to a patient's heart, including transfemoral access. The delivery devices and systems may be utilized for transcatheter percutaneous procedures, including transarterial procedures, which may be transfemoral or transjugular. Transradicular procedures may also be utilized, among others. Other procedures may be utilized as desired.

[0231] Features of the embodiments may be modified, substituted, omitted, or combined throughout the embodiments as desired.

[0232] Additionally, the methods herein are not limited to those specifically described, but may include methods utilizing the systems and apparatus disclosed herein, and method steps may be modified, omitted, or added using the systems, apparatus, and methods disclosed herein.

[0233] Features of the embodiments disclosed herein may be implemented independently of the crimping device or independently of other components disclosed herein. Various units of the system may be implemented independently.

[0234] In summary, although aspects of the present specification are emphasized by reference to particular embodiments, it will be understood that those skilled in the art will readily recognize that these disclosed embodiments are merely illustrative of the principles of the subject matter disclosed herein. Accordingly, it should be understood that the disclosed subject matter is in no way limited to the particular methodology, protocols, and / or reagents, etc., described herein. Accordingly, various modifications or variations of the presently disclosed subject matter, or alternative configurations, can be made in accordance with the teachings herein without departing from the spirit of the present specification. Finally, the terminology used herein is for the purpose of describing particular embodiments only and is not intended to limit the scope of the systems, devices, and methods as disclosed herein, which are defined only by the claims. Therefore, the systems, devices, and methods are not limited to the precise manner as shown and described.

[0235] Particular embodiments of systems, apparatus, and methods are described herein, including the best mode known to the inventors for carrying them out. Of course, variations on these described embodiments will become apparent to those of ordinary skill in the art upon reading the foregoing description. The inventors expect those of ordinary skill in the art to adopt such variations as appropriate, and the inventors contemplate systems, apparatus, and methods that are embodied otherwise than as specifically described herein. Accordingly, the systems, apparatus, and methods include all modifications and equivalents of the subject matter recited in the claims appended hereto as permitted by applicable law. Furthermore, any combination of the above-described embodiments in all possible variations thereof is encompassed by the systems, apparatus, and methods unless otherwise indicated herein or clearly contradicted by context.

[0236] Groupings of alternative embodiments, elements, or steps of systems, devices, and methods are not to be construed as limiting. Each group member may be referred to and claimed individually or in any combination with other group members disclosed herein. It is anticipated that one or more members of a group may be included in, or deleted from, a group for reasons of convenience and / or patentability. When such inclusion or deletion occurs, the specification will be deemed to contain the modified group and thus satisfy the description of all Markush groups used in the appended claims.

[0237] Unless otherwise indicated, all numbers expressing features, items, quantities, parameters, properties, terms, etc. used in the specification and claims are to be understood as being modified in all instances by the term "about." As used herein, the term "about" means that the feature, item, quantity, parameter, property, or term so modified encompasses approximations that may vary, but can still perform the desired operation or process discussed herein.

[0238] The terms "a," "an," "the," and similar reference words used in the context of describing systems, devices, and methods (particularly in the context of the claims below) shall be construed to cover both the singular and the plural unless otherwise indicated herein or clearly contradicted by context. All methods described herein may be performed in any suitable order unless otherwise indicated herein or clearly contradicted by context. The use of any and all examples or exemplary language (e.g., "such as") provided herein is intended merely to better illuminate the systems, devices, and methods and does not pose a limitation on the scope of the systems, devices, and methods otherwise claimed. No language in the specification should be construed as indicating any non-claimed element essential to the practice of the systems, devices, and methods.

[0239] All patents, patent publications, and other publications referenced and identified in this specification are individually and expressly incorporated herein by reference in their entirety for the purpose of describing and disclosing the compositions and methodologies described in such publications, which may be used in connection with, for example, the systems, apparatus, and methods. These publications are provided solely for their disclosure prior to the filing date of the present application. Nothing in this regard should be construed as an admission that the inventors are not entitled to antedate such disclosure by virtue of prior invention or for any other reason. All statements as to the date or representation as to the contents of these documents are based on the information available to the applicants and do not constitute an admission as to the accuracy of the dates or contents of these documents. [Explanation of symbols]

[0240] 10 Implants 12 Proximal end 14 distal end 16 frames 18a~18c leaflet 20 Skirt 22 Posts 24 Junction 26 Opening 28 Exterior 30 Inner 32a~32c Upper end part 34a~34c Inner surface 36a~36c External surface 37 Flow path 38a~38c outer part 40a~40f tab 42a~42c suture line 44 Delivery device 46 Thin Shaft 48 Distal portion 50 proximal part 52 Handle 53 lines 54 Implant Retention Area 56 Nosecone 58 Balloon 60 Control Mechanism 62 fluid ports 64 Outer sheath 66 Intermediate sheath 68 Internal Shaft 70 Distal Shoulder 72 Distal end 74 proximal end 76 Distal Shoulder 78 Proximal Shoulder 82 Middle part 84 Crimping Device 86 Base 88 Handle 90 internal channels 92 Proximal surface 94 Proximal opening 96 Interlocking structure 97 parts 98 Main Unit 100 Pressing Surface 102 axes 104 Distal surface 106 Distal opening 108 parts 109 Receptor 110 Support 112 Tapered Support Surface 114 first end portion 116 Second end portion 118 Cylindrical outer surface 120 surface 122 depression 124 Matching Device 126 Connector part 128 Proximal central opening 130 Center Channel 134 Surface 136 Distal central opening 138 Ring body 140, 142 surface 144 Exterior 146 Inside 148 Central Channel 150a~150c indicator 152 First Arm 154 Second Arm 156 First end portion 158 Second end portion 160 Pivot Point 162 first end portion 164 Second end portion 166 First Lever 168 Second Lever 170 Coupler 171 Axial width 172 Proximal Positioning Device 174 Main Unit 176 First Part 178 Second Part 180 hinge 182 Central Channel 184 flange 190 Support 192 Matching Device 193 Opening 194 Alignment Guide 195 Retainer 196 Support surface 197 Inner 198 Central Channel 200 Stopper Housing 202 Cavity 204 Main Unit 206 Exterior 208 Large diameter proximal part 210 Small diameter distal portion 212 Coupler 214 Proximal end 216 Distal end 218 Opening 220 distal surface 222 Opening 224 Internal contact surfaces 230 Stopper housing 232 Main Unit 234 Main Unit 236 Cavity 238 Coupler 240 Stopper Housing 242, 244 main body 246 Internal Channels 248 proximal part 250 compression arm 260 Spacer body 261 Housing 262 Proximal part 264 Contact surfaces 266 Distal part 267 Distal Cavity 268 Exterior 269 ​​Internal contact surfaces 270 Proximal Cavity 272 Distal Cavity 274, 276 Windows 277 Distal Surface 278 Proximal aspect 280 Spacer body 282 Distal part 284 proximal part 286, 288, 290 hollow 292, 296 windows 294, 295 contact surfaces 298 flange 300 spacer body 302 Proximal part 303 Cavity 304 Contact surfaces 305 Internal contact surfaces 310 Spacer body 312 Balloon Cover 313 Internal cavity 314 Coupler 316 Proximal Opening 318 Contact surfaces 320 Elongated body 322 channels 324 proximal end 326 parts 327 Side 328 Surface 329 Distal end 330 Side 331 Elastic Retainer 332 Elongated opening 334 Coupler 335 Opening 336, 338 Edge 339, 344 pins 340, 342 coupler 346 Elongated body 352 pins 354 Opening 356 parts 400 Crimping Device 402 Thin Strands 402a Strand 404 First Edge 406 Second End 408 Elongated tube 410 axes 412 channels 414 Central part 416 Inner diameter 417 First Support 419 Second Support 420, 422 openings 424, 426 diameter 428, 430 Opening 432, 434 Gripping part 436 Retainer body 438 First Part 440 Second Part 442 Rotating Coupler 444 Rotating Coupler 450 Crimp Implant 452 First Funnel 454 Second Funnel 460 End part 461 Sheath 462 Projecting end part 464 Central part 470 Retainer body 474 Piston 480 Thin Strands 490 Thin Strands 492 Piston 572 Prosthetic Heart Valve Assembly 574 Stent Lattice 576 Graft Enclosure 578 Jack Assembly 580 Graft Materials 582 Valve leaflet 584 Commissure Plate 586 Post 1090 channels

Claims

[Claim 1] 1. A system for use in crimping a prosthetic implant having one or more valve leaflets onto a delivery device, the system comprising: a support configured to be inserted into a crimping device, the support having a support surface configured to be positioned between the one or more valve leaflets and the delivery apparatus and to support the one or more valve leaflets in an open position.

Images