Systems and methods for crimping and device preparation

Abstract

This application relates to devices, systems, and methods for crimping implants and for device preparation. Devices in certain embodiments can include a crimping device for compressing an implant prior to implant deployment to a portion of a patient's body. A support body can be used to reduce the likelihood of damage to the implant during the crimping process. Other bodies can be utilized to improve the accuracy of the crimping position of the implant on a delivery device.

Description

[0001] Cross-references to related applications

[0002] This application claims the benefits 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 which are incorporated herein by reference. Technical Field

[0003] Some embodiments disclosed herein may relate to apparatus, systems, and methods for curling implants. Systems in some embodiments may be used for curling prosthetic implants. Some embodiments disclosed herein may relate to apparatus, systems, and methods for device fabrication. Background Technology

[0004] Human heart valves, including the aortic, pulmonary, mitral, and tricuspid valves, essentially function as one-way valves that work in sync with the beating heart. Valves allow blood to flow downstream but prevent it from flowing upstream. Diseased heart valves exhibit defects such as stenosis or regurgitation, which inhibit the valve's ability to control blood flow. These defects reduce the heart's pumping efficiency and can become a sign of failure and life-threatening symptoms. For example, valvular insufficiency can lead to symptoms of cardiac hypertrophy and ventricular dilation. Therefore, extensive efforts have been made to develop methods and devices to repair or replace heart valves.

[0005] Prostheses exist to correct problems associated with damaged heart valves. For example, mechanical and tissue-based heart valve prostheses can be used to replace damaged natural heart valves. Recently, significant efforts have been devoted to developing replacement heart valves, particularly tissue-based replacement heart valves, which can be delivered to patients with less trauma than through open cardiac surgery. Replacement valves are being designed to be delivered via minimally invasive procedures and even percutaneous procedures. Such replacement valves typically consist of a tissue-based valve body that is attached to an expandable frame and then delivered to the annulus of the natural valve.

[0006] The development of prostheses, including but not limited to replacement heart valves that can be compressed for delivery and then controllably expanded for controlled placement, has proven particularly challenging. Delivery devices can be provided to deploy such implants to desired locations within the body. When coupled to a delivery device, the implant can be in a compressed state and therefore must be compressed for delivery to the desired implantation site within the patient.

[0007] These implants can be self-expandable, balloon-expandable, or mechanically expandable. Balloon-expandable prosthetic valves typically roll down from an initial large diameter to a smaller diameter before being advanced to the treatment site in the body. Before rolling, balloon-expandable prosthetic valves are usually placed on an inflatable balloon on the catheter axis. Once delivered to the implantation site, the balloon can be inflated to expand the prosthetic valve to its functional size. Self-expanding prosthetic implants are also typically rolled down to a smaller diameter but are then inserted into a sheath. After placement in the body, the sheath is retracted, and the prosthetic valve expands inside the body. Mechanically expandable prosthetic implants can also be rolled down to a smaller diameter.

[0008] Methods exist for curling such implants before delivery; however, it may be desirable to provide improved devices, systems, and methods for curling and the fabrication of other devices. Summary of the Invention

[0009] Embodiments of this disclosure may relate to apparatus, systems, and methods for curling implants, as well as other apparatus, systems, and methods for device fabrication. The apparatus, systems, and methods disclosed herein may relate to more accurately positioning implants on delivery devices and more efficiently curling implants onto delivery devices. Certain features disclosed herein may relate to improving the functionality of implants after deployment, including reducing the likelihood of damage to the implant during the curling process. Other features may relate to improved methods of bending or otherwise positioning the elongated shaft of the delivery device during the curling procedure or other device fabrication procedures.

[0010] One or more embodiments of this disclosure include a system for rolling a prosthetic implant having one or more leaflets into a delivery device. The system may include a support body configured to be inserted into the rolling device and having a support surface configured to be positioned between the one or more leaflets and the delivery device and for supporting the one or more leaflets in an open position.

[0011] One or more embodiments of this disclosure include a system for curling a prosthetic implant having one or more leaflets into a delivery device. The system may include an annular body comprising one or more indicators indicating the rotational position of the prosthetic implant relative to the annular body.

[0012] One or more embodiments of this disclosure include a method. The method may include positioning a delivery device within a channel of a curling device, the curling device including one or more pressing surfaces configured to radially compress a prosthetic implant within the channel.

[0013] The method may include positioning a prosthetic implant within a channel and around a delivery device, the prosthetic implant comprising one or more leaflets. The method may also include positioning a support body within the channel and between the one or more leaflets and the delivery device.

[0014] The method may include supporting one or more leaflets in an open position via a support body. The method may also include using one or more pressing surfaces of a curling device to curl the prosthetic implant into a delivery device.

[0015] One or more embodiments of this disclosure include a system for curling a prosthetic implant having one or more leaflets into a delivery device. The system may include a stop housing including a cavity configured to receive a portion of the delivery device distal to an implant holding region, and the stop housing including a contact surface configured to abut against the delivery device to impede axial distal movement of the delivery device when the delivery device is positioned within the curling device, the curling device being configured to curl the prosthetic implant into the delivery device.

[0016] One or more embodiments of this disclosure include a method. The method may include positioning a delivery device within a channel of a curling device including one or more pressing surfaces configured to radially compress a prosthetic implant within the channel. The method may also include positioning the prosthetic implant within the channel and around the delivery device.

[0017] The method may include a portion of the delivery device abutting against the stop housing adjacent to the implant holding region of the delivery device to define the position of the delivery device within the channel of the curling device. The method may include curling a prosthetic implant into the delivery device using one or more pressing surfaces of the curling device.

[0018] One or more embodiments of this disclosure include a system for rolling a prosthetic implant having one or more leaflets into 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 region of the delivery device, and the spacer body includes a contact surface for abutting a distal end of the prosthetic implant to define the position of the prosthetic implant on the delivery device.

[0019] One or more embodiments of this disclosure include a method. The method may include positioning a spacer body on a portion of the delivery device distal to the implant retention region of the delivery device. The method may include positioning a prosthesis implant on the delivery device.

[0020] The method may include having the distal end of the prosthetic implant abut against the contact surface of the spacer body to define the position of the prosthetic implant on the delivery device. The method may also include curling the prosthetic implant into the delivery device in an appropriate position.

[0021] One or more embodiments of this disclosure include a system. The system may include an elongated body comprising a channel for receiving an elongated shaft of a delivery device having a proximal portion and a distal portion, the elongated body being configured to bend in at least one plane to move the distal portion of the delivery device toward the proximal portion of the delivery device.

[0022] One or more embodiments of this disclosure include a method. The method may include a bent elongated body including a channel that receives an elongated shaft of a delivery device, the elongated shaft being received in at least one plane such that a distal portion of the delivery device is positioned close to a proximal portion of the delivery device.

[0023] One or more embodiments of this disclosure include a coiling system for prosthetic implants. The coiling system may include a plurality of elongated strands, each having a first end and a second end and arranged to form an elongated tube extending about an axis and surrounding a channel configured to receive a prosthetic implant, and having a central portion with an inner diameter. The coiling system may include a first support body coupled to a first end of each of the plurality of elongated strands. The coiling system may include a second support body coupled to a second end of each of the plurality of elongated strands and configured to rotate relative to the first support body about an axis to reduce the inner diameter and compress the prosthetic implant within the channel.

[0024] One or more embodiments of this disclosure include a method. The method may include positioning a prosthetic implant within a channel of a coiling device. The coiling device may include a plurality of elongated strands, each elongated strand having a first end and a second end, and arranged to form an elongated tube extending about an axis and surrounding the channel, and including a central portion having an inner diameter. A first support body is coupled to the first end of each of the plurality of elongated strands, and a second support body is coupled to the second end of each of the plurality of elongated strands. The method may include rotating the second support body relative to the first support body about an axis to reduce the inner diameter and compress the prosthetic implant within the channel. Attached Figure Description

[0025] The features and advantages of the systems, apparatuses, and methods disclosed herein will be understood, and will be better understood, through reference to the specification, claims, and drawings, wherein:

[0026] Figure 1 A side perspective view of a prosthetic implant according to an embodiment of the present disclosure is shown.

[0027] Figure 2 It shows Figure 1 The image shows a top view of the prosthetic implant, with the leaflets of the implant in a closed position.

[0028] Figure 3 It shows Figure 1 The image shows a top view of the prosthetic implant, with the leaflets of the implant in the open position.

[0029] Figure 4 A side view of a delivery device according to an embodiment of the present disclosure is shown.

[0030] Figure 5 A detailed view of a portion of a delivery apparatus according to an embodiment of the present disclosure is shown.

[0031] Figure 6 A rear perspective view of a curling apparatus according to an embodiment of the present disclosure is shown.

[0032] Figure 7 It shows Figure 6 The front perspective view of the curling device shown.

[0033] Figure 8 A front perspective view of a support body according to an embodiment of the present disclosure is shown.

[0034] Figure 9 An embodiment according to this disclosure is shown. Figure 8 The rear perspective view of the supporting structure shown.

[0035] Figure 10 An embodiment according to this disclosure is shown. Figure 8 The side sectional view of the supporting body shown.

[0036] Figure 11 A front perspective view of a ring body according to an embodiment of the present disclosure is shown.

[0037] Figure 12 An embodiment according to this disclosure is shown. Figure 11 The rear perspective view of the ring-shaped body shown.

[0038] Figure 13 It shows Figure 11 The cross-sectional view of the annular body shown.

[0039] Figure 14 It shows the location at Figure 8 The supporting body shown Figure 11 The ring-shaped main body is shown.

[0040] Figure 15 It shows that Figure 14The configuration shown is a side view of the ring-shaped body positioned on the support body.

[0041] Figure 16 A perspective view of a positioning device located on a delivery apparatus according to an embodiment of the present disclosure is shown.

[0042] Figure 17 A front view of a prosthetic implant positioned on a support body and adjacent to a ring-shaped body according to an embodiment of the present disclosure is shown.

[0043] Figure 18 A perspective view shows a prosthetic implant positioned on a support body and inserted into a curling device.

[0044] Figure 19 A side sectional view is shown of the implant positioned on the support body and within the curling device.

[0045] Figure 20 It shows the emission from the curling device. Figure 19 The side sectional view of the support body shown.

[0046] Figure 21 A rear perspective view of a support body configured to be inserted into a curling device according to an embodiment of the present disclosure is shown.

[0047] Figure 22 A rear perspective view of a stopper housing according to an embodiment of the present disclosure is shown.

[0048] Figure 23 It shows Figure 22 The front perspective view of the stop housing shown.

[0049] Figure 24 It shows Figure 22 The shown is a side sectional view of the stop housing.

[0050] Figure 25 A front perspective view of a curling apparatus according to an embodiment of the present disclosure is shown.

[0051] Figure 26 The image shows a coupling to a curling device according to an embodiment of the present disclosure. Figure 22 The shown is a side sectional view of the stop housing.

[0052] Figure 27 A front perspective view of the stop housing according to an embodiment of the present disclosure is shown.

[0053] Figure 28 A rear perspective view of the stop housing according to an embodiment of the present disclosure is shown.

[0054] Figure 29A side view of a spacer body according to an embodiment of the present disclosure is shown.

[0055] Figure 30 It shows Figure 29 The cross-sectional view of the spacer body is shown.

[0056] Figure 31 It shows Figure 29 The image shows a side perspective view of the spacer body, in which a partially curled implant is positioned within the spacer body.

[0057] Figure 32 It shows the location at Figure 29 A side view of the nose cone within the spacer body shown.

[0058] Figure 33 It shows the location at Figure 29 The image shows a side view of a partially curled implant within the spacer body.

[0059] Figure 34 The positioning of the abutment curling device according to an embodiment of the present disclosure is illustrated. Figure 29 The spacer body shown.

[0060] Figure 35 A rear perspective view of the spacer body according to an embodiment of the present disclosure is shown.

[0061] Figure 36 It shows Figure 35 The front perspective view of the spacer body shown.

[0062] Figure 37 It shows Figure 35 The side sectional view of the spacer body shown.

[0063] Figure 38 A side view of the spacer body according to an embodiment of the present disclosure is shown.

[0064] Figure 39 It shows Figure 38 The side sectional view of the spacer body shown.

[0065] Figure 40 A perspective view of the spacer body according to an embodiment of the present disclosure is shown.

[0066] Figure 41 It shows Figure 40 The perspective view of the spacer body shown is shown, with a portion of it shown in cross-section.

[0067] Figure 42 A perspective view of an elongated body according to an embodiment of the present disclosure is shown.

[0068] Figure 43 It shows Figure 42 The side view of the slender body shown.

[0069] Figure 44 The image shows a curved configuration. Figure 42 A perspective view of the slender main body shown.

[0070] Figure 45 A side sectional view of a portion of an elongated body according to an embodiment of the present disclosure is shown.

[0071] Figure 46 A side sectional view of a portion of an elongated body according to an embodiment of the present disclosure is shown.

[0072] Figure 47 A side sectional view of a portion of an elongated body according to an embodiment of the present disclosure is shown.

[0073] Figure 48 A delivery device positioned within an elongated body according to an embodiment of the present disclosure is shown.

[0074] Figure 49 The diagram illustrates a bent configuration according to an embodiment of the present disclosure. Figure 48 The slender body shown.

[0075] Figure 50 A side view of a portion of an elongated body according to an embodiment of the present disclosure is shown.

[0076] Figure 51 The image shows a curved configuration. Figure 50 A side view of a portion of the slender body shown.

[0077] Figure 52 A side view of an elongated body according to an embodiment of the present disclosure is shown.

[0078] Figure 53 It shows Figure 52 The cross-sectional view of the slender body shown along line 53-53.

[0079] Figure 54 A perspective view shows a prosthetic implant positioned on a support body and inserted into a curling device.

[0080] Figure 55 A side sectional view is shown of the implant positioned on the support body and within the curling device.

[0081] Figure 56 It shows the emission from the curling device. Figure 55 The side sectional view of the support body shown.

[0082] Figure 57 A side view of a curling device according to an embodiment of the present disclosure is shown.

[0083] Figure 58 It shows Figure 57 A schematic cross-sectional view of the curling device shown.

[0084] Figure 59 It shows Figure 57 The perspective end view of the curling device shown.

[0085] Figure 60 It shows Figure 57 A schematic diagram of the cross-section of the winding equipment along line AA.

[0086] Figure 61 It shows a prosthetic implant positioned therein. Figure 57 The curling device shown.

[0087] Figure 62 It shows a prosthetic implant positioned therein. Figure 57 A schematic diagram of the cross-section of the curling device is shown.

[0088] Figure 63 A prosthetic implant with curling is shown. Figure 57 The side view of the curling device shown.

[0089] Figure 64 A prosthetic implant with curling is shown. Figure 57 The diagram shows a cross-sectional view of the coiling device.

[0090] Figure 65 It shows Figure 57 The diagram shows a cross-sectional view of the curling device, in which a capsule extends onto the curled prosthetic implant.

[0091] Figure 66 A cross-sectional view of a curling apparatus according to an embodiment of the present disclosure is shown.

[0092] Figure 67 A cross-sectional view of a curling apparatus according to an embodiment of the present disclosure is shown.

[0093] Figures 68A-68C A perspective view of a prosthetic implant according to an embodiment of the present disclosure is shown. Detailed Implementation

[0094] Figure 1A perspective view of a prosthetic implant 10, which replaces a heart valve, is shown. The prosthetic implant 10 can be configured to be deployed within a portion of a patient's body. For example, the prosthetic implant 10 can be deployed within a natural heart valve ring, which may include a natural aortic valve, or in embodiments, a natural mitral, tricuspid, or pulmonary valve. In embodiments, the implant 10 can have other forms and may include, as needed, a stent or other form of medical implant.

[0095] The prosthetic implant 10 may include a proximal end 12 and a distal end 14, as well as a length between the proximal and distal ends. The prosthetic implant 10 may include a body in the form of a frame 16. The prosthetic implant 10 may also include one or more of a plurality of leaflets 18a-18c coupled to the frame 16, and may include a skirt 20 covering the outer surface of the distal portion of the frame 16.

[0096] Frame 16 may include a plurality of struts 22 connected at joint 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 frame 16 and also allow frame 16 to be compressed to reduce its diameter and to be expanded to increase its diameter. Frame 16 may be configured to compress radially and elongate axially upon radial compression. The struts 22 may be configured such that the length of frame 16 can increase when frame 16 is compressed to reduce its diameter. Moreover, the length of frame 16 can decrease when frame 16 is expanded to increase its diameter. Frame 16 may be compressed in various ways, including using a coiling device, and may be expanded in various ways, including balloon expansion, self-expanding, or mechanically expandable. Embodiments herein may refer to balloon-expandable implants, but self-expanding or mechanically expandable implants may also be used.

[0097] Frame 16 may include an outer surface 28 configured to press against the patient's internal vascular system. For example, when frame 16 is extended, outer surface 28 may contact and press against the patient's internal vascular system. In embodiments, outer surface 28 may press against a natural valve annulus or a natural leaflet of a heart valve. Frame 16 may include an inner surface 30 ( Figure 2 (The inner surface 30 is configured to face away from the outer surface 28 and to be a flow channel facing the implant 10.)

[0098] The skirt 20 can cover the outer surface 28 of the distal portion of the frame 16, such as Figure 1As shown, and may include a membrane or other form of skirt 20. Skirt 20 may improve the compliance of frame 16 with the natural valve in which implant 10 is implanted, and may be used to couple leaflets 18a-18c to frame 16 via sutures of other forms of coupling elements.

[0099] Multiple leaflets 18a-18c (in) Figure 2 (As shown more clearly in the image) can extend inward from the inner surface 30 of the frame 16. Multiple leaflets 18a-18c can be configured to move toward each other to reach a closed position (as shown in the image). Figure 2 (as shown) and move away from each other to move to the open position (as shown) Figure 3 As shown). Leaflets 18a-18c can each include the upper portion 32a-32c (as shown). Figure 3 The upper portions 32a-32c are configured to contact each other when the leaflets 18a-18c are in the closed position to close the flow channel of the implant 10. The upper portions 32a-32c are configured to move away from each other to open the flow channel of the implant 10 when the leaflets 18a-18c are in the open position. The leaflets 18a-18c can move back and forth between the open and closed positions or states or configurations to replicate the movement of the natural valve.

[0100] Each leaflet 18a-18c may include an inner surface 34a-34c. Figure 3 (as indicated by the bid) and outer surface 36a-36c ( Figure 2 (Pointed out), the inner surfaces 34a-34c are configured to face the flow channel of the implant 10, and the outer surfaces 36a-36c face away from the inner surfaces 34a-c and are away from the flow channel 37 of the implant 10. When the leaflets 18a-18c move to the closed position, portions of the inner surfaces 34a-34c of each leaflet 18a-18c can contact each other.

[0101] Each leaflet 18a-18c may include a corresponding external portion 38a-38c coupled to the frame 16 of the implant 10. Figure 2 Winning bid Figure 2 The coupling elements can take various forms. For example, each leaflet 18a-18c may include tabs 40a-40f at the corresponding outer portions 38a-38c of the leaflets 18a-18c. Tabs 40a and 40b may extend from leaflet 18a, tabs 40c and 40d may extend from leaflet 18b, and tabs 40e and 40f may extend from leaflet 18c. Tabs 40a-40f may extend through openings in frame 16 to couple to frame 16, and may then be sewn to hold tabs 40a-40f in place. Tabs 40a-40f may form commissures between adjacent leaflets 18a-18c.

[0102] Furthermore, the outer portions 38a-38c of each leaflet 18a-18c can be sutured to the skirt 20 along suture lines 42a-42c. For example, the lower portions of each leaflet 18a-18c opposite the upper portions 32a-32c can be sutured to the skirt 20 at the corresponding suture lines 42a-42c. The sutures of the suture lines 42a-42c can hold the leaflets 18a-18c on the frame 16 and prevent unwanted fluid from flowing through the implant 10 outside the flow channel 37.

[0103] Leaflets 18a-18c can 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. Leaflets 18a-18c can be configured to impede fluid flow in the opposite direction from the outflow end to the inflow end of the implant 10 when leaflets 18a-18c are in the closed position.

[0104] In this embodiment, other forms of implants, such as stents or other forms of medical devices, may be used. Figures 1-3 The configuration of the implant shown can be changed in the embodiments.

[0105] The implant 10 can be configured to be delivered to the implantation site using a delivery device. For example, Figure 4 An embodiment of a delivery device 44 for delivering an implant 10 to a desired implantation site is shown. The delivery device 44 may include an elongated 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 region 54 and a distal end that may include a nasal cone 56. The distal portion 48 may also include an inflatable body in the form of a balloon 58. The delivery device 44 may be configured to be located within a coiling device to coil the implant 10 into the implant holding region 54. The elongated shaft 46 may be positioned within the coiling device. The balloon 58 may be configured for coiling the implant 10 thereon.

[0106] The handle 52 can be configured for a user to grip and operate the delivery device 44 and manipulate it through the patient's vascular system. For example, the handle 52 can be moved distally to advance the elongated shaft 46 distally within the patient's body, and can be moved proximally to retract the elongated shaft 46 proximally within the patient's body. Thus, by operating the handle 52, the implant holding area 54 and, correspondingly, the implant 10 can be moved and positioned.

[0107] The control mechanism 60 may be further coupled to the handle 52. The control mechanism 60 may be configured to operate as needed to bend the elongated shaft 46. For example, one or more pull tethers may extend along the elongated shaft 46, and operation of the control mechanism 60 may push or pull one or more pull tethers to bend the elongated shaft 46. Therefore, the bending of the elongated shaft 46 can be controlled by the control mechanism 60. Figure 4 As shown, the control mechanism 60 may include a rotatable body, which is in the form of a control knob and can be rotated to push or pull a rope and bend the elongated shaft 46. Other forms of control mechanisms may be used as needed.

[0108] The fluid port 62 can also be coupled to the handle 52 and can be used to transfer fluid to and from the balloon 58 as needed. The configuration of the handle 52 can be varied in other embodiments as required.

[0109] Figure 5 A close-up view of the distal portion 48 of the elongated shaft 46 is shown. The elongated shaft 46 may include one or more shafts, which may include one or more sheaths extending over each other. For example, the elongated shaft 46 may include an outer sheath 64, which may be configured to extend over and be slidable relative to an intermediate shaft or intermediate sheath 66, the intermediate sheath 66 including the shaft interior of 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 the nasal cone 56 of the elongated shaft 46. The inner shaft 68 may be surrounded by a balloon 58. In this embodiment, the inner shaft 68 may include fluid conduits that allow fluid to enter and exit the balloon 58 to inflate and deflate the balloon 58, respectively. Other shafts may include one or more fluid conduits for inflating and deflating the balloon 58 as needed.

[0110] The inner shaft 68 may also include a distal shoulder 70, which may be positioned distal to the implant retention region 54. The distal shoulder 70 includes a portion of a delivery device 44 located distal to the implant retention region 54, and other portions such as a distal end 72 including a nasal cone 56 and a balloon 58. The distal shoulder 70 may project radially outward from the inner shaft 68 and may have a conical shape if desired. The conical shape may be configured such that the size of the distal shoulder 70 increases in the direction toward the implant retention region 54. The distal shoulder 70 may be configured to protect the implant 10 positioned within the implant retention region 54 as the elongated shaft 46 is advanced through the patient's body. For example, when the implant 10 is in a curled-up state, the outer diameter of the distal shoulder 70 may be equal to or greater than the diameter of the implant 10, thus protecting the leading edge (such as the distal end 14 of the implant 10) from contact with a part of the patient's body or from being hooked or caught on a sheath through which the slender shaft 46 can be pushed.

[0111] The balloon 58 may have a distal end 72 and a proximal end 74, and may extend along the inner axis 68 and the distal shoulder 70. The distal end 72 may be coupled to the nasal cone 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 axis 68 and may surround the inner axis 68. The balloon 58 in... Figure 5 The image is shown in a scaled-down state and may have a distal shoulder 76 and a proximal shoulder 78. An implant holding region 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, wherein the diameter of the intermediate portion 82 may be smaller than the diameters of the distal shoulder 76 and the proximal shoulder 78. In embodiments, the diameter of the intermediate portion 82 may be constant as needed.

[0112] It is worth noting that, in an embodiment, the proximal shoulder 78 of the balloon 58 may be shaped as a shoulder without extending onto the shoulder of the inner shaft 68. Therefore, the inner shaft 68 may lack an internal proximal shoulder in an embodiment.

[0113] In one embodiment, the inner shaft 68 may include a shoulder portion proximal to the implant retention region 54. In this embodiment, the proximal shoulder portion 78 of the balloon 58 may extend onto the proximal shoulder of the inner shaft 68.

[0114] The implant holding region 54 can be configured for the implant 10 to curl onto the balloon 58 and be positioned in the intermediate portion 82 between the distal shoulder 76 and the proximal shoulder 78 of the balloon 58. The implant 10 can be positioned proximally to the distal shoulder 76 and curled in such a location. In some embodiments, when the implant 10 is curled, the outer sheath 64 can be advanced distally to cover the implant 10 located within the implant holding region 54. In some embodiments, the outer sheath 64 can be advanced distally relative to the intermediate sheath 66 to abut / abut against the proximal edge (or proximal end 12) of the implant 10.

[0115] In this embodiment, the configuration of the delivery device can be determined from... Figure 4 and 5 The configuration changes shown are as follows.

[0116] The implant 10 can be rolled up to the implant retention area 54 in various ways. For example, Figure 6 A rear perspective view (or a view taken from the proximal side of the curling device 84) is shown. The curling device 84 may include a base 86, an actuator in the form of a handle 88, and a channel 90 for inserting the implant 10 and delivery device 44 therein. The curling device 84 may include a proximal side 92, which includes a proximal opening 94 leading to the channel 90. The proximal opening 94 may be configured to insert and pass the delivery device 44 into the channel 90. The proximal side 92 may also include a mating structure 96 in the form of a slit, which may be configured to engage with a positioning device 172 (e.g., as shown in the image). Figure 16 (As shown) The proximal side 92 may also include a cutout portion 97, which may be configured to receive an alignment device as disclosed herein for the support body. The cutout portion 97 may be configured as a notch or other shape in the proximal side 92.

[0117] The curling device 84 may also include a rotatable body 98 configured to rotate with rotation of the handle 88. The curling device 84 can be operated via a plurality of pressing surfaces 100 surrounding the channel 90 and configured to apply compressive force to radially compress the implant 10 located 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 rotates, the body presses and moves the pressing surfaces 100 toward the center of the channel 90, and the diameter of the channel 90 decreases. The pressing surfaces 100 may form an iris structure that allows the pressing surfaces 100 to move toward the center of the channel 90 and reduce the diameter of the channel 90. Therefore, due to the radial compressive force of the pressing surfaces 100 on the implant, the implant 10 positioned within the channel 90 will be compressed within the channel 90.

[0118] Figure 7 A front perspective view (or a view viewed from the distal side of the curling device 84) is shown. The curling device 84 may include a distal side 104, which includes a distal opening 106 leading to a channel 90. The distal side 104 may include a cutout portion 108, which may be configured as a notch or other shape in the distal side 104.

[0119] The distal opening 106 can be configured as part of the delivery device 44 to pass through it during the curling operation performed by the curling device 84.

[0120] The configuration of the curling device can be changed as needed in the embodiments.

[0121] During operation, the implant 10 can be positioned on the implant holding region 54 of the delivery device 44, and then the delivery device 44 and the implant 10 positioned thereon can be inserted into the channel 90. However, if the leaflets 18a-18c of the implant 10 are in a closed position when the implant 10 curls into the delivery device 44 (e.g., Figure 2 As shown in the diagram, this could lead to adverse conditions for the implant 10. For example, if the implant 10 is coiled to the delivery device 44 while the leaflets 18a-18c are in the closed position, one or more sutures coupling the leaflets 18a-18c to the frame 16 may cause the suture hole to elongate. The suture hole may elongate along one or more sutures 42a-42c, as shown in the diagram. Figure 2 As shown. Elongation of the suture hole can lead to various adverse conditions, including separation of the lobules 18a-18c from the frame 16, and may cause obstruction of the flow channel 37 of the implant 10 (in Figure 3 A reduction in the integrity of the fluid seal on the outer side (marked out). Further adverse conditions may include... Figure 2 Undesirable pull-out of the flaps 40a-40f, or misalignment of the flaps 40a-40f at the commissure. It is believed that positioning the leaflets 18a-18c in the open position during the curling of the implant 10 can reduce one or more of the aforementioned adverse conditions.

[0122] The support body can be used to support one or more leaflets 18a-18c in the open position. For example, Figure 8A perspective view of a support body 110 according to an embodiment of the present disclosure is shown. The support body 110 may be configured to be inserted into a curling device and may have a support surface 112 configured to be positioned between one or more leaflets 18a-18c and a delivery device 44 and for supporting the one or more leaflets 18a-18c in an open position. The support body 110 may have a first end 114 and may extend to a second end 116 including the support surface 112. The support body 110 may include a system for curling a prosthetic implant having one or more leaflets into the delivery device, and the system may include other components as needed.

[0123] The first end portion 114 may have a cylindrical shape, having a cylindrical outer surface 118. The first end portion 114 may extend to a proximal-facing surface 120, which may extend laterally to the cylindrical outer surface 118. The proximal-facing surface 120 may connect the first end portion 114 to a second end portion 116, which includes a support surface 112. The proximal-facing surface 120 may include an alignment device in the form of a recess 122, which may be configured to receive a coupling 170 of the annular body 138, such as... Figure 12 As shown.

[0124] Alignment device 124 can be positioned on first end 114 and configured to rotatably align support body 110 with coiling device 84. Orientation device 124 can be circumferentially positioned at appropriate location on first end 114 to rotatably align support body 110 with coiling device 84. Orientation device 124 may include axially extending protrusions, such as... Figure 8 As shown, or in other embodiments, other configurations may be available, such as recesses or other forms of alignment devices. Alignment device 124 may be configured to insert a cutout portion 108 into the distal side 104 of the curling device 84 to rotatably align the support body 110 with the curling device 84. Alignment device 124 may also be configured to allow the support body 110 to slide distally out of the cutout portion 108 during operation of the curling device 84. In embodiments, alignment device 124 may be inserted into the proximal side of the curling device 84 and may be inserted into the cutout portion 97, for example, as... Figure 54 and Figure 55 As shown.

[0125] The second end 116 may extend proximally from the first end 114. The support body 110 at the second end 116 may include a support surface 112. The support surface 112 may have a tapered shape, tapering downwards in the direction toward the second end 116. The diameter of the support surface 112 decreases in the direction toward the second end 116. The support surface 112 may have, for example... Figure 8The conical shape shown, or in other embodiments, may have other shapes as needed. The support surface 112 may be as follows: Figure 8 The maximum diameter shown is smaller than the diameter of the cylindrical first end 114, or it can have another configuration as needed. Connector portion 126 (in Figure 10 (The marked surface) can connect the support surface 112 to the proximal surface 120, and can have a cylindrical shape with a constant diameter, or another shape as needed.

[0126] The support surface 112 can be configured for the inner surfaces 34a-34c of the leaflets 18a-18c to contact and rest upon when the implant 10 is positioned on the support surface 112. The support surface 112 is configured to resist movement of the leaflets 18a-18c to a closed position when the implant 10 is positioned on the support surface 112 and within the curling device 84.

[0127] When the pressing surface 100 of the curling device 84 presses against the support surface 112, the tapered shape of the support surface 112 allows the support body 110 to slide distally. Therefore, the tapered shape can cause the pressure applied by the pressing surface 100 to move proximally along the tapered shape of the support surface 112, and thus, in response, move the support body 110 distally. However, when the pressing surface 100 presses against the tapered support surface 112, the support surface 112 can hold the leaflets 18a-18c in an open position. The tapered shape of the support surface of the support body may include a wide portion and a narrow portion, and positioning the prosthetic implant on the support body may include positioning the prosthetic implant on the support body such that one or more leaflets open in a direction from the wide portion toward the narrow portion. The support body 110 may be configured to slide axially away from the implant 10 when the curling device 84 curls the implant 10. For example, the support body 110 can be configured to insert into the channel 90 of the curling device 84 and slide axially away from the channel 90 when the curling device 84 curls the implant 10, and can slide axially in the distal direction away from the implant within the channel.

[0128] The support body 110 may include a central hole 128 leading to a central channel 130. The central hole 128 and the central channel 130 may be configured to allow the delivery device 44 to extend through them. The support surface 112 may extend around the central channel 130. The central hole 128 may be positioned on a second end 116, and the central channel 130 may extend from the second end 116 to a first end 114.

[0129] Figure 9A distal perspective view of the support body 110 is shown. The first end 114 includes a distally facing surface 134 that extends perpendicularly to and connects to the cylindrical outer surface 118. The distally facing surface 134 includes a central hole 136 leading to a central channel 130, which extends to a central hole 128 at the second end 116. Figure 8 (As shown).

[0130] Figure 10 A cross-sectional view of the support body 110 is shown. The central channel 130 is shown extending from the distal central hole 136 to the proximal central hole 128.

[0131] In operation, the implant 10 can slide distally onto the support surface 112 of the support body 110, wherein the frame 16 extends over the support surface 112 and the inner surfaces 34a-34c of the leaflets 18a-18c extend over the support surface 112. In one embodiment, the implant 10 can slide distally, wherein the distal end 14 of the implant 10 leads / guides in a direction from the second end 116 to the first end 114. In another embodiment, the implant 10 can slide onto the support body, wherein the proximal end of the implant leads. This configuration can be utilized if a delivery path to the implant site opposite to the distal end leading of the implant can be used. To align the leaflets 18a-18c on the support surface 112 with a desired rotational orientation, and to separate the implant 10 from the proximal-facing surface 120 at a desired distance, an annular body can be utilized and positioned on the support body 110.

[0132] For example, Figure 11 A perspective view of an annular body 138 that can be used with a support body 110 is shown. The annular body 138 can be configured to extend around the support body 110. The annular body 138 may include a first surface that may be a proximal surface 140, and a surface 142 that is opposite to the first surface and may be a distal surface (in... Figure 12 The second surface (highlighted) and the outer surface 144, the outer surface 144 facing outward and connecting the proximal surface 140 to the distal surface surface 142. The annular body 138 may include an inner surface 146 opposite to the outer surface 144, and the inner surface 146 facing and surrounding the central channel 148 of the annular body 138.

[0133] An alignment guide may be positioned on the annular body 138 and may include one or more indicators 150a-150c indicating the rotational position of the implant 10 relative to the annular body 138. Each indicator 150a-150c may indicate the rotational position of the implant 10 on the support body 110. Each indicator 150a-150c may include a mark or other form of indicator on one or more proximal surfaces 140, distal surfaces 142, or the outer surface 144 of the annular body 138. For example, each indicator 150a-150c may include variations in the surface profile of the annular body 138, such as raised or recessed portions. Figure 11 Each of the indicators 150a-150c shown includes a recessed portion in the form of a groove on the proximal surface 140 and extending to the outer surface 144. The indicators 150a-150c may be further printed with varying colors to make them more easily visible. In an embodiment, the indicators 150a-150c may be printed solely on the annular body 138 without using variations in the surface contour.

[0134] Indicators 150a-150c may be circumferentially spaced apart on the annular body 138 and may be equidistant from each other. The position of each indicator 150a-150c may correspond to the position of one or more leaflets 18a-18c of the implant 10. The position of each indicator 150a-150c may, for example, correspond to and indicate the position of one or more foci of one or more leaflets 18a-18c. In this way, the user can position the annular body 138 on the support body 110 and align the foci of the leaflets 18a-18c with the corresponding indicator 150a-150c.

[0135] The annular body 138 may include one or more arms 152, 154, each arm 152, 154 extending around the central channel 148. Each arm 152, 154 may have an arcuate shape forming the annular body 138. Each arm 152, 154 may include half of the annular body 138 or may include other amounts as needed.

[0136] The first arm 152 may include a first end 156 and a second end 158, wherein the first end 156 is positioned at a pivot 160 that couples the first arm 152 to the second arm 154. The second end 158 of the first arm 152 may include a coupling member for coupling to the second arm 154. The second arm 154 may include a first end 162 positioned at the pivot 160 and a second end 164 positioned at the coupling member. The coupling member may include a recess in the second end 158 of the first arm 152 and a protrusion at the second end 164 of the second arm 154. The protrusion may extend into the recess and may be held in place by an interference fit or other form of coupling. Thus, the second ends 158, 164 of the respective first arm 152 and second arm 154 may be configured to couple to each other to hold the annular body 138 together. If necessary, the annular body 138 can be separated from and removed from the support body 110 by separating the second ends 158, 164 from each other and pivoting the arms 152, 154 about the pivot 160 to the open position. The annular body 138 can be opened to be removed from the support body 110 and can be closed to remain on the support body 110.

[0137] like Figure 11 As shown, a first lever 166 can extend radially outward from a first arm 152, and a second lever 168 can extend radially outward from a second arm 154. The first lever 166 and the second lever 168 can each be configured to be pressed to rotate the first arm 152 or the second arm 154 about a pivot 160 so that the annular body 138 moves to an open position.

[0138] The annular body 138 may have an axial width 171, which may define the implant 10 and Figure 8 The spacing of the proximal surfaces 120 of the support body 110 shown.

[0139] Figure 12 A distal perspective view of the annular body 138 is shown. A coupling 170 extends distally from the distally facing surface 142. The coupling 170 can be configured as a protrusion or other form of coupling. The coupling 170 can be configured to extend to... Figure 8 In the recess 122 shown. The coupling 170 can be circumferentially positioned relative to the recess 122, such that the annular body 138 is rotatably aligned with the support body 110. The coupling 170 can be rotatably aligned with the annular body 138 and the support body 110.

[0140] Figure 13 A cross-sectional view of the annular body 138 is shown. Figure 13 The image shows the second end 164 of the second arm 154 inserted into the recess of the second end 158 of the first arm 152.

[0141] In operation, the annular body 138 can be positioned on the support body 110, wherein the indicators 150a-150c are positioned relative to the support body 110 with a desired rotational alignment. For example, Figure 12 The coupling 170 shown can enter the recess 122 at a rotational position, thereby allowing the annular body 138 to be rotatably positioned relative to the support body 110 as needed. For example, Figure 14 An annular body 138 is shown on the support body 110, wherein the coupling 170 is inserted into the recess 122. Figure 15 A side view of the annular body 138 on the support body 110 is shown, wherein the coupling 170 is inserted into the recess 122. In other embodiments, other alignment devices may be used to rotatably align the annular body 138 relative to the support body 110 with a desired rotational alignment.

[0142] The ring-shaped main body 138 can be adjacent to / abut against. Figure 8 The surface 120 shown faces the near side. Figure 11 The axial width 171 of the annular body 138 shown can define the distance between the implant 10 and the proximal surface 120 of the support body 110. When the prosthetic implant 10 is positioned on the support body 110, the annular body 138 can be configured to abut the prosthetic implant 10. Therefore, the implant 10 can be positioned on the support surface 112, wherein an end of the implant 10 abuts the proximal surface 140 of the annular body 138 and defines the position of the implant 10 on the support surface 112. Therefore, the annular body 138 may include spacers configured to define the position of the implant 10 on the support body 110.

[0143] The annular body 138 can be placed in an open configuration with arms 152 and 154 open, and then the annular body 138 can be placed on the support body 110 with arms 152 and 154 closed to secure the annular body 138 around the support body 110. For example, the annular body 138 can be positioned... Figure 10 On the connector portion 126 shown.

[0144] The implant 10 can then be positioned on the support surface 112 and abutting the proximal surface 140 of the annular body 138. The implant 10 can be positioned on the support surface 112, wherein the commissure of the leaflets 18a-18c is aligned with the indicators 150a-150c and the end of the implant 10 is adjacent to the proximal surface 140.

[0145] The use of the annular body 138 advantageously allows the joining portion of the leaflets 18a-18c and the leaflets 18a-18c themselves to be positioned relative to the annular body 138 and therefore relative to the support body 110 in a desired rotational orientation. Figure 8 The alignment device 124 on the support body 110 shown can be rotatably aligned with the curling device 84, and thus place the connecting portion of leaflets 18a-18c and leaflets 18a-18c themselves in the curling device 84 with the desired rotational orientation.

[0146] It may be desirable to position the commissure of leaflets 18a-18c and leaflets 18a-18c in a known rotational orientation within the curling device 84, thereby curling the implant 10 into the delivery device 44 in a known rotational orientation. Thus, when the implant 10 is curled, the user who curls the implant 10 into the delivery device 44 can know the position of the commissure of leaflets 18a-18c and leaflets 18a-18c on the delivery device 44. Therefore, during the deployment of the implant 10 from the delivery device 44, the user can be able to position the commissure and leaflets 18a-18c in a desired orientation relative to the implantation site. For example, if the implant 10 is deployed to a natural heart valve, the prosthetic leaflets 18a-18c and commissure can be deployed in an orientation that closely matches the position of the natural leaflets with the commissure. Therefore, by placing the commissure and leaflets 18a-18c in a known orientation relative to the delivery device 44, more efficient deployment of the implant 10 can be achieved.

[0147] The support body 110 and the annular body 138 can each be part of a system for rolling a prosthetic implant with one or more leaflets into a delivery device. In an embodiment, the system may include a positioning device 172 configured to be coupled to a portion of the delivery device 44 proximal to the implant holding region 54. For example... Figure 16 An embodiment of such a positioning device 172, positioned proximal to the implant holding region 54, is shown. The positioning device 172 includes a body 174, which includes a first portion 176 and a second portion 178 connected at a hinge 180. The body 174 may include a central channel 182 in which a delivery device 44 may be positioned, and the second portion 178 rotates about the hinge 180 to close the central channel 182 and retain the delivery device 44 within the central channel 182.

[0148] The body 174 may also include a mating surface in the form of a flange 184, the flange 184 being configured to... Figure 6 The mating structure 96 of the near side 92 of the curling device 84 shown is engaged.

[0149] Positioning device 172 can be used to couple to delivery device 44 and suspend the shaft of delivery device 44 in a suitable position within the channel 90 of winding device 84. Therefore, positioning device 172 can keep delivery device 44 spaced apart from the pressing surface 100 of winding device 84, for example... Figure 19 As shown. Furthermore, the positioning device 172 can be positioned axially along the delivery device 44, thereby holding the implant holding region 54 in a defined axial position within the channel 90 of the curling device 84. This feature further allows for… Figure 5 The distal shoulder 70 of the inner shaft 68 shown is positioned outside and distal to the channel 90 of the curling device 84, so that the distal shoulder 70 is not pressed by the pressing surface 100 during curling. The delivery device 44 can also be held in a defined axial position relative to the implant 10 positioned on the support body 110.

[0150] The operating method of the system disclosed herein may include the following steps. Some steps may be modified, excluded, or replaced in the embodiments as needed.

[0151] In the initial step, the implant 10 to be rolled up can be soaked to improve the ease of rolling up the implant 10.

[0152] Then, the annular body 138 can, for example, be... Figure 15 The configuration shown is positioned on the support body 110. For example, the annular body 138 can be positioned via, for example, via... Figure 13 The coupling 170 shown is with Figure 8 The recess 122 shown is coupled and rotatably oriented on the support body 110 in a defined position. Thus, the implant 10 can be positioned on the support surface 112, with the commissure of the leaflets 18a-18c oriented toward the indicators 150a-150c. The implant 10 can be abutted against the annular body 138 to define the position of the implant 10 on the support body 110.

[0153] For example, Figure 18 An implant 10 is shown sliding onto a support surface 112 of a support body 110, wherein the distal end 14 ( Figure 1 (Pointed out) The adjacent surface 140 facing proximally. The inner surfaces 34a-34c of each leaflet 18a-18c contact the support surface 112 of the support body 110 and are held in the open position. The merging portion of the leaflets 18a-18c is aligned with the indicators 150a-150c. The implant 10 can be held on the support surface 112 at axial intervals, the axial intervals corresponding to the axial width 171 of the annular body 138 (e.g., ...). Figure 11 (marked in the middle).

[0154] With the implant 10 positioned on the support surface 112, the annular body 138 can then be removed from the support body 110 before the implant 10 is rolled into the delivery device 44. For example, the rods 166, 168 can be pressed to rotate the arms 152, 154 about the pivot 160 and open the annular body 138.

[0155] With the annular body 138 removed, the support body 110 can be inserted into the curling device 84, wherein the implant 10 is positioned on the support surface 112. For example, Figure 18 An implant 10 is shown positioned on a support surface 112, wherein the implant 10 and the support body 110 are inserted into a channel of a curling device 84. A distal opening 106 of the curling device 84 can be configured to insert the support body 110 into and through a channel 90. The support body 110 can be configured to insert into the distal opening 106 of the curling device 84. The channel 90 of the curling device 84 can be configured to receive the implant 10, the support body 110, and the elongated shaft 46 of the delivery device 44. When the support body 110 is inserted into the channel of the curling device 84, an alignment device 124 can be aligned with the incision portion 108 of the curling device 84. Therefore, the rotational orientation of the support body 110 within the channel of the curling device 84, and thus the rotational orientation of the implant 10 within the channel of the curling device 84, can be set.

[0156] When the support body 110 and the implant 10 are inserted into the channel of the curling device 84, Figure 16 The positioning device 172 shown can be coupled to the proximal portion of the delivery device 44 and then inserted into, for example, Figure 6 The flange 184 of the positioning device 172 can be inserted into the proximal opening 94 of the curling device 84. Figure 6 The mating structure 96 shown is a mating structure.

[0157] Figure 19 A cross-sectional view is shown of a pressing surface 100 positioned around a channel 90 of a curling device 84, wherein a support body 110 is inserted into the channel 90, and an implant 10 is positioned on a support surface 112. Leaflets 18a-18c are supported on the support surface 112, with inner surfaces 34a-34c of leaflets 18a-18c contacting the support surface 112. Leaflets 18a-18c extend proximally and are supported in an open position. The frame 16 of the prosthetic implant 10 extends proximally and surrounds leaflets 18a-18c, the support surface 112, and an elongated axis 46.

[0158] The support body 110 extends proximally, with the second end 116 guided proximally toward the proximal opening 94 of the curling device 84. The support surface 112 may be surrounded by the pressing surface 100. The first end 114 of the support body 110 may be positioned outside and distal to the pressing surface 100 and may be held within the distal opening 106 of the curling device 84. The alignment device 124 may extend proximally into the cutout portion 108 of the curling device 84.

[0159] The elongated shaft 46 of the delivery device 44 is positioned within the channel 90 of the curling device 84. The implant 10 is positioned within the channel 90 and around the delivery device 44. The support body 110 is positioned within the channel 90 and between the leaflets 18a-18c and the delivery device 44. The support body 110 supports the leaflets 18a-18c in an open position. The elongated shaft 46 of the delivery device 44 extends distally within the internal channel 90 of the curling device 84 and distally within the central channel 130 of the support body 110. The channel 90 can be configured to allow the elongated shaft 46 of the delivery device 44 to be distally advanced through the distal opening 106. The support surface 112 extends around the elongated shaft 46 of the delivery device 44.

[0160] Positioning device 172 can be coupled to the proximal portion of the elongated shaft 46 of delivery device 44 and can engage with the mating structure 96 of the proximal side 92. Positioning device 172 can be coupled to the proximal portion of shaft 46 at an appropriate location, thereby positioning implant holding region 54 within channel 90 and relative to implant 10 at the desired location. For example, as Figure 19 As shown, the implant 10 can be positioned around the implant holding region 54, wherein the proximal shoulder 78 of the balloon 58 is positioned proximal to the implant 10 and the distal shoulder 76 of the balloon 58 is positioned distal to the implant 10.

[0161] Furthermore, the positioning device 172 can be coupled to the proximal portion of the shaft 46 at an appropriate location, thereby positioning the distal shoulder 70 of the inner shaft 68 distal to the pressure surface 100 and thus lateral and distal to the channel 90. This feature reduces the likelihood of the pressure surface 100 compressing the distal shoulder 70 and reduces the possibility of damage to the distal shoulder 70, which could reduce its ability to protect against curling of the implant 10.

[0162] In addition, due to previous use Figure 17 The annular body 138 shown allows for rotational alignment of the implant 10 relative to the elongated axis 46, thus ensuring the desired alignment.

[0163] With the slender shaft 46, the support body 110, and the implant 10 in the desired position within the channel 90, the actuator of the curling device 84 can be actuated to compress the implant 10. For example, as Figure 6 As shown, the handle 88 can be rotated to rotate the rotatable body 98 and cause the pressing surface 100 to move radially inward against the implant 10. For example, Figure 20 The pressing surface 100, which has been moved radially inward to apply compressive force to the implant 10, is shown. The implant 10 is rolled into the delivery device 44 by utilizing the pressing surface 100 of the curling device 84. The implant 10 has been compressed radially inward toward the implant holding region 54 of the elongated axis 46. Furthermore, the length of the implant 10 has been increased axially. The proximal shoulder of the balloon 58 may be flattened or otherwise reduced in size.

[0164] The implant 10 can be rolled up, with the leaflets 18a-18c held and secured in the open position. Therefore, when the pressing surface 100 is pressed toward the implant 10, the supporting surface 112 can support the leaflets 18a-18c. Rolling the implant 10 into the delivery device 44 may include applying force through the pressing surface 100 to the supporting surface 112 of the supporting body 110, causing the supporting body 110 to slide axially away from the implant 10 within the channel 90.

[0165] The tapered shape of the support surface 112 causes the support body 110 to slide distally away from the channel 90 and away from the pressure surface 100 as the pressure surface 100 moves radially inward. The support body 110 is configured to be releasably coupled to the curling device 84 and slide axially away from the channel 90 as the curling device 84 curls the implant 10. In an embodiment, the support body 110 can be ejected distally from the distal opening 106, such as... Figure 20 As shown. The distal end of the slender shaft 46 slides proximally relative to the central channel 130 of the support body 110 and then slides out. Figure 8 As shown in the central hole 128, the support body 110 can pop out. The support body 110 can slide axially relative to the leaflets 18a-18c. The elongated shape of the alignment device 124 allows the alignment device 124 to slide distally out of the cutout portion 108.

[0166] In one embodiment, the support body 110 may remain coupled to the winding device 84 instead of popping out during winding. For example, the support body 110 may slide distally while a pull cord or other form of coupling keeps the support body 110 coupled to the winding device 84 so that the support body 110 does not fall off.

[0167] As the implant 10 is curled up to the elongated shaft 46, the positioning device 172 can disengage from the mating structure 96 and move proximally to pull the elongated shaft 46 proximally from the proximal opening 94. The positioning device 172 can be removed from the elongated shaft 46, and the implant 10 remains curled up to the implant holding region 54.

[0168] The use of the support body 110 advantageously allows the leaflets 18a-18c of the implant 10 to remain in the open position during curling. This feature reduces the likelihood of adverse conditions on the implant 10 during curling. Furthermore, the tapered shape of the support surface 112 allows the support body 110 to slide distally by radially inward movement of the pressing surface 100, thereby automatically moving the support body 110 distally. The support body 110 can automatically slide distally, so that the support surface 112 is not positioned between the implant 10 and the pressing surface 100 after curling. In an embodiment, the system can be configured such that a separate mechanism slides the support body 110 distally, so that the tapered shape is not used for the support surface 112. For example, an arm or gear or other form of coupling can engage the support body 110 to move the support body 110 away from the implant 10.

[0169] The use of the support body 110 further advantageously allows implants 10 of various sizes to be rolled using the same rolling device 84. If an implant with a varying diameter or length is rolled using the rolling device 84, the dimensions of the support surface 112 can be altered to accommodate the implant. The implant can then be positioned on the support surface and inserted into the channel 90 of the rolling device 84, and rolled over an implant holding area sized to fit the implant. The positioning device 172 can be positioned along the length of the elongated axis 46 to continue holding the distal shoulder 70 of the elongated axis outside the pressing surface 100.

[0170] Figure 21 A distal perspective view showing a variation of the support body 190 is provided, including an alignment device 192 having a recess in the outer surface of the support body 190. An opening 193 on the distal side of a curling device (not shown) is shown, wherein the opening 193 is aligned with... Figure 7 The distal opening 106 shown is positioned on the distal side in a similar manner. The alignment device 192 can be configured to rotatably align the support body 190 with the alignment guide 194 of the winding device. For example, the alignment guide 194 may include a protrusion that slides into a recess in the alignment device 192 when the support body 190 slides into the winding device in a proximal direction. Therefore, the alignment device 192 can operate to... Figure 8 The alignment device 124 shown is rotated to align the support body 190 in a similar manner.

[0171] The support body 190 can be configured to engage a retainer 195, which can be positioned on the inner surface 197 of the opening 193. The retainer 195 can be configured to selectively engage a catch on the support body 190 to allow the support body 190 to be held in place within the opening 193. The catch can disengage from the retainer 195 as the support body 190 slides distally. For example, the retainer 195 may include a detent device that deflects to allow the catch to release and allow the support body 190 to slide distally. The relative positions of the retainer 195 and the catch can be further rotatably aligned between the support body 190 and the opening 193.

[0172] The support body 190 may also include a support surface 196, the support surface 196 and Figure 8 The support surface 112 shown operates similarly. The support body 190 may also include components similar to... Figure 10 The central channel 130 shown operates similarly to the central channel 198.

[0173] The supporting body 190 can be with Figure 19 and Figure 20 The supporting body 110 shown in the diagram operates in a similar manner.

[0174] In embodiments, other configurations of the support body and the annular body may be used as needed. Embodiments may be used separately from or in conjunction with other components disclosed herein. In one embodiment, the support body may be configured to insert into the proximal side of the coiled body, for example, to engage. Figure 6 The cutout portion 97 is shown. The support body 110 can be configured to insert into the proximal opening 94 of the curling device.

[0175] For example, Figure 54 An implant 10 is shown positioned on a support surface 112, wherein the implant 10 and the support body 110 are inserted into a channel of a curling device 84. A proximal opening 94 of the curling device 84 can be configured to insert and pass the support body 110 into the channel 90. The channel 90 of the curling device 84 can be configured to receive the implant 10, the support body 110, and the elongated shaft 46 of the delivery device 44.

[0176] like Figures 11 to 15 The annular body 138 shown in one embodiment can be coupled to the support body 110 and used to align the implant 110 onto the support body 110, wherein the support body 110 is inserted into the proximal opening 94 of the curling device 84.

[0177] In one embodiment, the support body 110 is inserted into the proximal opening 94 of the curling device 84. Figure 16 The positioning device 172 shown can be excluded from use. In this way, the support body 110 can be positioned at the proximal opening 94 of the curling device 84, instead of at the positioning device 172.

[0178] For example, Figure 55 A support body 110 extending distally is shown, wherein a second end 116 is guided distally toward the distal opening 106 of the curling device 84. A support surface 112 may be surrounded by a pressing surface 100. A first end 114 of the support body 110 may be positioned outside and proximal to the pressing surface 100 and may be held within the proximal opening 94 of the curling device 84.

[0179] The tapered shape of the support surface 112 causes the support body 110 to slide proximally away from the channel 90 and away from the pressure surface 100 as the pressure surface 100 moves radially inward. The support body 110 is configured to be releasably coupled to the curling device 84 and slide axially away from the channel 90 when the curling device 84 curls the implant 10.

[0180] like Figure 56 As shown, the support body 110 can be ejected proximally from the proximal opening 94. The support body 110 can be ejected when the elongated shaft 46 slides distally relative to the central channel 130 of the support body 110. The support body 110 can slide axially relative to the leaflets 18a-18c and can slide proximally away from the channel of the curling device when the prosthetic implant is curled by the curling device. The elongated shape of the alignment device 124 allows the alignment device 124 to slide proximally out of the incision portion 97. The elongated shaft 46 can then be retracted proximally from the curling device 84. The support body 110 can be positioned about the elongated shaft 46 and can then slide distally to be removed from the elongated shaft 46.

[0181] like Figures 54 to 56 The configuration shown allows implant 10 to be coupled with Figures 18 to 20 The opposite orientation shown is curled onto the elongated shaft 46 of the delivery device (e.g., coaxial curl, rather than as shown). Figures 18 to 20 (as shown in the retrograde curling). Thus, the orientation of leaflets 18a-18c and the flow direction of implant 10 can be aligned with... Figures 18 to 20 The opposite of what is shown. In Figures 18 to 20 In this configuration, the implant 10 can be positioned on an elongated axis 46 to allow fluid to flow proximally through the implant 10 during implantation. However, in cases such as Figures 54 to 56 In the illustrated embodiment, the implant 10 may be positioned on the elongated shaft 46 to allow flow in the distal direction when the implant 10 is implanted.

[0182] Thus, in such Figures 54 to 56 In the configuration shown, implant 10 can be coupled with Figures 18 to 20 The orientation shown is opposite to that shown, and the implant is placed at the implantation site. Therefore, Figures 54 to 56 The path / approach to the implantation site (such as a natural valve) in the illustrated embodiments can be compared with... Figures 18 to 20 The illustrated embodiment is the opposite. For example, in Figures 18 to 20 In the illustrated embodiment, the path to the aortic valve can occur via the femoral artery, and along the aortic arch and toward the aortic valve in the ventricular direction. The implant 10 can be implanted into the aortic valve in a flow direction away from the left ventricle. Figures 54 to 56 In this embodiment, the path to the implantation site can be in the opposite direction to the implantation site (and the flow direction of the natural valve). For example, the path to the mitral valve can be via the septum (e.g., from the right atrium to the left atrium via septal puncture) and then toward the mitral valve in the ventricular direction. The implant 10 thus has a flow direction in the ventricular direction, and therefore... Figures 18 to 20 The directions shown are opposite.

[0183] In this embodiment, other paths can be utilized. Figures 54 to 56 The orientation of the implant 10 shown. For example, it can be used that requires alignment with... Figures 18 to 20 The opposite orientation of the implant 10 shown is via an apical or other pathway.

[0184] Other methods for rolling the implant 10 into the delivery device can be used as needed. In an embodiment, the user may be able to choose whether to insert the support body 110 into the proximal opening 94 or the distal opening 106. For example, the proximal opening 94 may be configured to insert the delivery device into the channel, and the distal opening 106 may be configured to insert the support body into the channel. Furthermore, the proximal opening 94 may be configured to insert the delivery device into the channel, and the proximal opening 94 may also be configured to insert the support body 110 into the channel.

[0185] Figure 22 An embodiment of a stop housing 200 according to an embodiment of the present disclosure is shown. The stop housing 200 may include a system for curling a prosthesis implant 10 into a delivery device 44. The stop housing 200 may include Figure 23 and Figure 24 The cavity 202, marked in the middle, can be configured to receive a portion of the delivery device 44 distal to the implant holding region 54. The stop housing 200 may include a contact surface 224. Figure 24(The part marked in the image) is configured to abut / contact the delivery device 44 to impede axial distal movement of the delivery device 44 when the delivery device 44 is positioned within the curling device 84, wherein the curling device 84 is configured to curl the dummy implant 10 to the delivery device 44. According to an embodiment, the stop housing may include a curling stop housing or a curling aid.

[0186] Figure 22 A distal perspective view of the stop housing 200 is shown. The stop housing 200 may include a body 204 having an outer surface 206 and a large-diameter proximal portion 208 and a smaller-diameter distal portion 210. The outer surface 206 of the body 204 may include one or more coupling members 212 configured to couple the stop housing 200 to a portion of the coiling device 84. For example, the coupling member 212 may 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.

[0187] In embodiments, coupling 212 can be configured to selectively engage a portion of the curling device 84. For example, coupling 212 can be configured to deflect radially inward to allow stop housing 200 to engage with or disengage from the curling device 84. Coupling 212 can be configured to deflect radially outward to allow stop housing to remain engaged with the curling device 84. For example, Figure 25 A perspective view of the distal opening 106 of the curling device 84 is shown. The curling device 84 may include a plurality of receivers 109 circumferentially spaced around the opening of the channel 90, which may be configured to allow a coupling 212 to pass through therein to engage the stop housing 200 to the curling device 84. In embodiments, other forms of coupling may be used.

[0188] The distal end 216 of the stop housing 200 may include an opening 218 for allowing a portion of the delivery device 44 to pass through it. For example, the distal end of the delivery device 44 may be configured to pass completely or partially through the opening 218.

[0189] Figure 23 A near-side perspective view of the stop housing 200 is shown. The stop housing may include a distal side 220 extending to an outer surface 206 of the stop housing 200. A cavity 202 may extend distally from the distal side 220 of the stop housing 200 and may extend from an opening 222 in the distal side 220.

[0190] Figure 24A cross-sectional view of the stop housing 200 is shown. The stop housing may include a contact surface 224. In this embodiment, the contact surface 224 may include the inner surface of a cavity 202 and may define the shape of the cavity 202. The inner surface of the cavity 202 may be angled in this embodiment and may have a tapered shape, such as... Figure 24 As shown. Therefore, the inner surface 224, and thus the cavity 202, can be shaped to conform to the shape of the delivery device, which may include the shape of the distal end of the delivery device 44. Thus, the cavity 202 can be configured to receive the distal end of the delivery device 44, wherein the contact surface 224 abuts the distal end at a distal insertion point of the delivery device 44. Therefore, the contact surface 224 can impede distal movement of the distal end of the delivery device 44. The contact surface 224 can be shaped to impede distal movement of the distal end of the delivery device 44 at a desired location within the channel 90 of the coiling device 84.

[0191] In an embodiment, the contact surface 224 may be shaped to impede distal movement of the distal end of the delivery device at a point, wherein the distal shoulder 70 of the inner shaft 68 ( Figure 5 The distal shoulder 70 of the delivery device 44 (highlighted in the center) is positioned distal to the pressure surface 100 and outside the channel 90. The contact surface 224 can be configured to abut / brace the delivery device to impede axial distal movement of the delivery device within the channel 90 of the curling device 84, thus defining the position of the delivery device within the channel 90, wherein the distal shoulder 70 of the delivery device 44 is positioned distal to the channel 90 and outside the channel 90. This feature allows the distal shoulder 70 of the inner shaft 68 to remain uncompressed during the curling of the implant 10 and therefore undamaged during the curling process. Thus, the distal shoulder 70 can remain capable of protecting the leading edge of the implant 10 (such as the distal end 14 of the implant 10). Therefore, the contact surface 224 can serve as a stop or reference point that positions the distal shoulder 70 distal to the pressure surface 100 and outside the channel 90.

[0192] In one embodiment, the cavity 202 may be configured to receive the distal shoulder 70 of the delivery device, such that the distal shoulder 70 is positioned within the cavity 202 during curling. The distal shoulder 70 may be positioned within the cavity 202 in one embodiment, or it may be positioned proximal to the cavity 202 in another embodiment. Other configurations may be used as needed. Furthermore, in one embodiment, a contact surface providing a stop point or reference point may be positioned externally to the cavity 202 to receive the delivery device.

[0193] Figure 25A distal perspective view of the distal opening 106 is shown, illustrating a receiver 109 circumferentially positioned around the opening 106. The receiver 109 can be configured to engage. Figure 23 The coupling 212 shown is used to engage the stop housing 200 to the coiling device 84.

[0194] Figure 26 A side cross-sectional view of a stop housing 200 engaged with the curling device 84 is shown. The stop housing 200 can be positioned at the distal opening on the distal side of the curling device 84 and can be coupled to the distal opening of the curling device 84. The stop housing 200 can be positioned by means of a cavity 202 axially positioned relative to the channel 90. A delivery device 44 is shown extending within the channel 90 and distally inserted into the cavity 202.

[0195] During operation, the implant can be inserted into the channel 90 of the coiling device 84. The stop housing 200 can be coupled to the coiling device 84 distally to the channel 90 on the distal side of the coiling device 84. The delivery device 44 can then be inserted distally into the channel 90 through the proximal opening 94 of the coiling device. The delivery device 44 can be advanced axially distally through the channel toward the distal opening. A portion of the delivery device 44 distal to the implant holding region 54 can abut against the stop housing 200 to define the position of the delivery device 44 within the channel 90 of the coiling device 84. The delivery device 44 can be inserted distally until the distal end of the delivery device 44 abuts the contact surface 224 of the stop housing 200. Figure 24 (Pointed out). The position of the delivery device 44 adjacent to the inner contact surface 224 can position the distal shoulder 70 distal to the pressing surface 100 and outside the channel 90. In this way, the distal shoulder 70 can be positioned to avoid compression of the pressing surface 100.

[0196] The pressing surface 100 can be pressed against the implant 10, and the implant 10 can be rolled into the delivery device 44. The delivery device 44 can then be retracted proximally from the proximal opening 94, with the implant 10 rolled into the device 44. If desired, the stop housing 200 can detach from the rolling device 84 in the distal direction. Figure 23 The coupling 212 shown can be detached from the curling device 84.

[0197] Specifically, if necessary, such as Figure 19 The proximal positioning device 172 shown can, for example, be excluded from use. The contact surface 224 of the stop housing 200 can define the axial position of the delivery device 44 within the channel 90, and therefore the positioning device 172 can be excluded from use. However, in an embodiment, the proximal positioning device 172 can be used to suspend the axis of the delivery device 44 within the channel 90.

[0198] The profile of the contact surface 224 can be defined based on the type of delivery device 44 to be used and the desired position of the delivery device 44 within the channel 90. For example, because the delivery device 44 can further pass through the stop housing 200, the narrower cavity 202 defined by the contact surface 224 can further position the delivery device proximally, and the wider cavity 202 can further position the delivery device distally. Other configurations of the contact surface 224 can be used as needed.

[0199] In this embodiment, the stop housing 200 can be coupled with... Figures 54 to 56 The embodiments shown are used in combination. For example, the stop housing 200 can be positioned on the distal side of the winding device 84, and the support body 110 can be positioned on the proximal side of the winding device 84, for example, as Figure 55 As shown. The stop housing 200 can be used to position the elongated shaft 46 at a desired location within the channel 90 and, if necessary, position the implant 10 relative to the implant holding region 54. The curling process can then be as follows: Figure 56 As shown.

[0200] Variations of the stop housing can be used. For example, Figure 27 A near-side perspective view of a stop housing 230 including two separable bodies 232, 234 is shown, which can be separated to open cavity 236. Figure 22 The stop housing 200 shown can also be separated to include a separable body. This feature allows the stop housing to be assembled onto the distal end of the delivery device to secure the stop housing in position on the delivery device.

[0201] The stop housing 230 may also include a coupling 238 in the form of a spring-biased protrusion, configured to spring outward to insert into the retainer of the winding device 84, and configured to retract to allow the stop housing 230 to be removed from the winding device 84. The stop housing 230 may be coupled with... Figure 26 The stop housing 200 shown operates in a similar manner.

[0202] Figure 28 A distal perspective view of an embodiment of the stop housing 240 is shown, which includes two separable bodies 242, 244 surrounding an internal channel 246, similar to Figure 27The stop housing 232 is shown. However, the stop housing 240 may include a proximal portion 248, which includes a plurality of compression arms 250 configured to extend within the channel 90 of the curling device 84 and to apply a pressing surface 100 to the compression arms 250. The compression arms 250 may extend onto and press against the implant 10 to curl the implant 10 into the delivery device 44. Thus, the compression arms can be used to assist in curling the implant 10 into the delivery device 44. In an embodiment, the proximal portion 248 may be separable from the bodies 242, 244.

[0203] The stop can advantageously provide a reference point or stop to impede distal axial movement of the delivery device 44 and axially position the delivery device 44 in a desired location within the curling device 84. The delivery device 44 can be positioned by positioning the distal shoulder 70 distal to the pressing surface 100 and outside the channel 90. Thus, the distal shoulder 70 can be positioned to prevent compression of the pressing surface 100. In this embodiment, the stop housing can be selectively coupled to the curling device 84 as needed.

[0204] The stop housing can be used alone or in combination with other components disclosed herein. The configuration of the stop housing can vary depending on the embodiments disclosed herein.

[0205] Figure 29 An embodiment of a spacer body 260 according to an embodiment of the present disclosure is shown. The spacer body 260 may be configured to extend over a portion of the delivery device 44 distal to the implant holding region 54 of the delivery device 44, and may include a contact surface 264 for abutting the distal end of the implant 10. Figure 30 (marked out) to define the position of the implant 10 on the delivery device 44.

[0206] The spacer body 260 may include a proximal portion 262 and may include a distal portion 266. The spacer body 260 may include an outer surface 268, which may be configured for gripping by a user. The proximal portion 262 may include a plurality of cavities, each cavity having a different size.

[0207] For example, Figure 30A cross-sectional view of the spacer body 260 is shown. The proximal portion 262 may include a proximal cavity 270, sized to receive the coiled implant 10. The proximal portion 262 may also include a distal cavity 272, sized to receive a portion of the delivery device 44 distal to the implant holding region 54, which may include the distal end of the delivery device 44. In an embodiment, the cavity 272 may be configured to receive the distal shoulder 70 of the delivery device. A contact surface 264 may be positioned between the distal cavity 272 and the proximal cavity 270 of the proximal portion 262.

[0208] The proximal portion 262 may include an opening or window 274. Figure 29 (highlighted), which allows the user to observe the implant 10 within the proximal cavity 270 and adjacent to the contact surface 264.

[0209] refer to Figure 30 The distal portion 266 may include a cavity 267, which includes a continuation of the distal cavity 272 of the proximal portion 262. In this embodiment, the cavity 267 of the distal portion 266 may be sized to be part of a delivery device 44 distal to the implant holding region 54, such as the distal end of the delivery device 44. The cavity 267 may be sized to prevent distal movement of the distal end. The distal portion 266 may also include an opening or window 276 (in...). Figure 29 (highlighted), which allows the user to observe the distal end located in the cavity 267 of the distal portion 266.

[0210] Figure 30 The marked contact surface 264 may include a first contact surface, and the spacer body 260 may include a second contact surface 269, which is configured to abut a portion of a delivery device, such as the distal end of the delivery device 44. The second contact surface 269 may be profiled to, for example, […]. Figure 24 The contact surface 224 of the stop housing 200 shown impedes distal movement of the delivery device 44 in a similar manner. For example, the second contact surface 269 may be the inner surface of one or more cavities 272, 267 and may be designed to profile to abut distal portions of the delivery device, such as the distal end.

[0211] The first contact surface 264 can be positioned on the outer and proximal sides of cavities 272 and 267, and can extend around the longitudinal axis of the spacer body 260. The first contact surface 264 can extend laterally to the longitudinal axis and can also extend perpendicularly, such as... Figure 30 As shown. The first contact surface 264 can be as follows: Figure 30 As shown, it is positioned on the distal side of the proximal side 278 of the spacer body 260, or for example, it can be as follows: Figure 38 and Figure 39 The embodiment shown includes the near side of the spacer body.

[0212] refer to Figure 31 As shown, the delivery device 44, with the implant 10 positioned thereon in a non-curled or partially curled state, can be distally inserted into the proximal cavity 270 and distal cavities 272, 267 of the spacer body 260 until the delivery device 44 contacts one or more cavities 272, 267 (e.g., ...). Figure 30 The contact surface 269 (marked in the middle) is blocked, thus hindering further distal movement. Therefore, the position of the spacer body 260 on the delivery device 44 can be defined.

[0213] The implant 10, in a non-curled or partially curled state, can then be advanced distally along the delivery device 44 until it contacts the contact surface 264. The contact between the implant 10 and the contact surface 264 defines the position of the implant 10 on the delivery device 44. Thus, the implant 10 can be placed at the desired position on the delivery device 44. The delivery device 44 can maintain contact with the inner contact surface 269, and the implant 10 can maintain contact with the lateral contact surface 264 to maintain the desired position of the implant 10 on the delivery device 44.

[0214] The method of using the spacer body 260 may include first placing the implant 10 within the curling device 84. The implant 10 may be covered with a cushioning body, for example... Alternatively, a buffer body of another form may be used. The implant 10 may be placed within the channel 90 of the curling device 84 and may be partially curled by the curling device 84. In one embodiment, the implant 10 may be positioned on the delivery device 44, although in other embodiments, the implant 10 may not be positioned on the delivery device during such a pre-curling procedure.

[0215] The buffer body can be removed from the partially curled implant 10. The partially curled implant 10 can be curled to allow the implant 10 to fit into the proximal cavity 270 of the spacer body 260. Figure 30 The diameter within (marked in the middle). Then, the spacer body 260 can be positioned on the delivery device 44 by sliding on the distal end of the delivery device 44 and the distal end entering the cavities 272, 267 of the proximal portion 262 and the distal portion 266, respectively. The spacer body 260 can be positioned on a portion of the delivery device 44 distal to the implant holding region 54. For example, Figure 31 The delivery device 44 and the implant 10 are shown inserted into the spacer body 260.

[0216] The distal end can be inserted distally until the distal end contacts the internal contact surface 269 of the cavity of the distal portion 266 (e.g., Figure 30 (Marked in the middle). The user can observe the distal end in the appropriate position through window 276 of the distal portion 266. For example, Figure 32 The distal end is shown in its proper position and is visible through window 276 of the distal portion 266. Therefore, the user can confirm that the delivery device 44 is in the desired position relative to the spacer body 260.

[0217] The partially curled 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 distal end abutting the contact surface 264 defines the position of the implant 10 on the delivery device 44. For example, Figure 33 An implant 10 is shown in contact with contact surface 264 and within proximal cavity 270. With the spacer body 260 in a defined position on delivery device 44, the partially curled implant 10 may also be placed in the defined position. The defined position may be a desired location on the implant holding area of ​​delivery device 44. In embodiments, the defined position may be located on a marker band or other imaging marker of delivery device 44 that defines the desired location of implant 10.

[0218] With the implant 10 positioned adjacent to the contact surface 264, the spacer body 260 and delivery device 44, while the implant 10 remains in contact with the contact surface 264, can be distally inserted through the proximal opening 94 of the curling device 84, as... Figure 6 As shown. The spacer body 260, delivery device 44, and implant 10 can continue distally through the channel 90 of the curling device 84 until the spacer body 260 is positioned distally to the pressing surface 100. For example, Figure 34 The spacer body 260 is shown at the distal side of the pressing surface 100 and the distal opening of the curling device 84.

[0219] The proximal portion of the spacer body 260 can remain abutted against the distal surface 277 of the body, which includes the pressing surface 100. The delivery device 44 and the implant 10 can be held in place against the spacer body 260 and thus maintain a defined relationship relative to the pressing surface 100.

[0220] With the implant 10 properly positioned in the channel 90, the pressing surface 100 can completely or partially curl 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 curled back into the delivery device 44 to complete the curling procedure.

[0221] Variations in the spacer body 260 can be used. For example, Figure 35 A distal perspective view of the spacer body 280 is shown, wherein the distal portion 282 has a cylindrical shape. The proximal portion 284 may include a plurality of cavities 286, 288 with different dimensions. Figure 37 (as indicated by the mark), and the distal portion 282 may include a cavity 290 with a size smaller than that of the cavity 288.

[0222] The proximal portion 284 may include an opening or window 292 for visualizing the contact of the implant 10 on the contact surface 294. The distal portion 282 may also include an opening or window 296 for observing the distal end of the delivery device 44 within the cavity 290 and adjacent to the contact surface 295 of the cavity 290.

[0223] The proximal portion 284 may further include a flange 298 extending radially outward from the proximal portion 284. The flange 298 may be used to clamp the proximal portion 284 and to position the proximal portion within an opening on the distal side of the curling device 84, for example... Figure 34 As shown.

[0224] Figure 36 A perspective view of the spacer body 280 is shown from the far side. Figure 37 A side cross-sectional view of the spacer body 280 is shown. A contact surface 294 for contacting the distal end of the implant 10 is shown. A contact surface 295 for contacting the distal end of the delivery device 44 is further shown.

[0225] Spacer body 280 can be with Figure 29 The spacer body 260 shown operates in a similar manner.

[0226] Figure 38 An embodiment of the spacer body 300 is shown, wherein the proximal portion 302 of the spacer body 300 lacks a shell for extending onto the implant 10, similar to Figure 29 The housing 261 shown. Figure 39 It shows Figure 38 The cross-sectional view of the spacer body 300 shown. The implant 10 can contact the spacer body 300. Figure 30 The contact surface 264 shown abuts the contact surface 304 of the spacer body 300 in a similar manner. The spacer body 300 may include a cavity 303 configured to receive a distal portion of the delivery device, and may include an internal contact surface 305 adjacent to the distal portion of the delivery device. Figure 38In the illustrated embodiment, the implant 10 can be fully rolled into the delivery device 44 by the rolling device 84 without the spacer body 300 being removed from the distal end of the delivery device 44. Then, after the implant 10 has been fully rolled, the spacer body 300 can be removed from the distal end.

[0227] Figure 40 An embodiment of a spacer body 310 is shown, which may be configured similarly to a spacer body 300 and may include a balloon cap 312 extending proximally from the spacer body 310. The balloon cap 312 may include a spacer body 58 (e.g., Figure 5 Above the (marked) elongated body of the balloon 58 to prevent damage. The coupling 314 can couple the balloon cap 312 to the spacer body 310 and can be configured to be separable from the spacer body 310. For example, the coupling 314 may include a clamp or other form of coupling that couples the balloon cap 312 to the spacer body 310.

[0228] Figure 41 A cross-sectional view of a balloon cap 312 is shown, positioned appropriately above the balloon 58. The balloon cap 312 may include an internal cavity 313 that conforms to the shape of the balloon 58, particularly the proximal shoulder 78 of the balloon 58. The balloon cap 312 may include a proximal opening 316 configured for a delivery device 44 to pass through.

[0229] In operation, the spacer body 310 and balloon cap 312 can be packaged on the delivery device 44, with the balloon cap 312 extending over the balloon 58. The balloon cap 312 protects the balloon 58. At the desired time for curling the implant 10, the balloon 58 and balloon cap 312 can be detached from the spacer body 310 and can be discarded. The implant 10 can then be pressed against the contact surface 318 of the spacer body 310 to position the implant 10 in the desired location relative to the implant holding area 54 of the delivery device 44.

[0230] The configuration of the spacer body can be varied in the embodiments as needed. Embodiments of the spacer body can be used alone or in combination with other components disclosed herein.

[0231] Figure 42An elongated body 320 according to an embodiment of the present disclosure is shown. The elongated body 320 may include a channel 322 for receiving an elongated shaft 46 of a delivery device 44. The delivery device 44 may include a proximal portion having a handle 52 and may include a distal portion having an implant holding region 54. The elongated body 320 may be configured to bend in at least one plane to move the distal portion of the delivery device 44 closer to the proximal portion of the delivery device 44.

[0232] The elongated body 320 may include a proximal end 324 and a distal end 329, and a length between the proximal end 324 and the distal end 329. The elongated body 320 may include a sleeve configured to extend along an elongated axis 46. The elongated body 320 may have walls forming a “U” shape extending around a channel 322 and may extend along the length of the elongated body 320.

[0233] The elongated body 320 can be configured in a straight position, and can be bent in a plane from a straight position to a curved or curved position. The elongated body 320 can be bent to cause the ends 324, 329 to face each other and approach each other. For example, Figure 44 The ends 324 and 329, which are already close to each other, are shown. In this curved configuration, the elongated body 320 can form a "U" shape.

[0234] The elongated body 320 may include multiple cutouts 326 positioned on a side surface 327 of the elongated body 320. The cutouts 326 can be positioned on one side of the elongated body 320 to form an inner curve when the elongated body 320 is bent. The elongated body 320 can be bent such that the cutouts 326 close and form the inner curve of the elongated body 320.

[0235] The cutout portion 326 can be shaped to define the elongated body 320 in a bent configuration. For example, each cutout portion 326 can have a wedge shape, wherein the angle between the opposing surfaces / opposite surfaces 328 is set to define the amount by which the elongated body 320 can be bent. Multiple cutout portions 326 can be configured such that when the elongated body 320 is bent, the opposing surfaces 328 of the cutout portions 326 ( Figure 43 The surfaces (highlighted) are configured to face each other and be able to contact each other. For example, opposing surfaces 328 can contact each other to define the radius of curvature of the elongated body 320 in a curved configuration.

[0236] refer to Figure 42 The cutout portion 326 can be positioned opposite to the side 330 of the elongated body 320, which includes an elongated opening 332 forming a "U"-shaped opening in the elongated body 320. The elongated shaft 46 can be inserted into the elongated body 320 by insertion through the elongated opening 332.

[0237] The elongated body 320 may include one or more coupling elements 334 configured to hold the elongated body 320 in a bent configuration and couple the ends 324, 329 of the elongated body 320 together when the elongated body 320 is in the bent configuration. The coupling element 334 may be in the form of a tether with an opening 335 at one end, the tether being configured to couple to a pin 339 or other device located at the proximal end 324 of the elongated body 320. The tether can maintain the distance between the proximal end 324 and the distal end 329 of the elongated body 320 when the elongated body 320 is in the bent configuration.

[0238] Figure 43 A side view of the slender body 320 is shown. Figure 44 A perspective view of the elongated body 320 in a curved configuration is shown. The cutout portion 326 has been closed to allow the elongated body 320 to move into the curved configuration. A coupling 334 may extend from the distal end 329 to the proximal end 324 and may be sufficiently robust to hold the elongated body 320 in the curved configuration.

[0239] In a curved configuration, the elongated opening 332 extending along the side 330 of the elongated body 320 can form an outward curve and can be slightly closed to further enclose the delivery device 44 located within the channel 322. For example, Figure 45 An elongated shaft 46 is shown located within a channel 322 of an elongated body 320, where the size of the opening 332 is reduced to a slightly closed state when the body 320 is in a bent configuration. The edges 336, 338 of the walls of the elongated body 320 are pulled toward each other to reduce the size of the opening 332. In this way, the walls can be used to hold the elongated shaft 46 of the delivery device 44 within the channel 322.

[0240] Other methods and devices can be used to retain the delivery device 44 within the channel 322. For example, such as... Figure 46 An embodiment is shown that can use a coupling 340 that pivots relative to the elongated opening 332. The coupling 340 can be a pivoting coupling configured to pivot to open and close to allow the delivery device 44 to be inserted into and retained within the channel 322. For example, the coupling 340 may include a lever arm pivotally coupled to a wall of the elongated body 320. Multiple couplings 340 may be used as needed along the length of the elongated opening 332.

[0241] Figure 47An embodiment is shown in which a strap-shaped coupling 342 can be used to hold the delivery device 44 to the elongated body 320. The strap can extend over the elongated opening 332 and can be configured to release and secure to a pin 344 or other coupling that can hold the coupling 342 in a fixed position. The coupling 342 can extend over the elongated shaft 46 of the delivery device 44 to hold the delivery device 44 in the elongated body 320.

[0242] Figure 52 An embodiment is shown that utilizes a coupling in the form of a resilient retainer 331 to retain the delivery device 44 to the elongated body 320. The resilient retainer 331 may be injection molded or otherwise positioned on the elongated body 320. One or more retainers 331 may be used, for example, retainers at one or more intermediate locations of the elongated body 320 between the proximal end 324, the distal end 329, and / or the proximal end 324 and the distal end 329. For example, as shown, four retainers 331 may be used, one at the proximal end 324, one at the distal end 329, and two positioned between the cut-out portions of the elongated body 320. In embodiments, only one retainer 331 or multiple retainers 331 may be used as needed.

[0243] Figure 53 It shows Figure 52 The diagram shows a cross-sectional view of the elongated body 320 along line 53-53. An elastic retainer 331 may extend around the elongated body 320 and may cover both the inner and outer surfaces of the elongated body 320. The retainer 331 may be injection molded onto the elongated body 320 to cover both the inner and outer surfaces of the elongated body 320. The retainer 331 may have two ends 333 positioned at an elongated opening 332 in the elongated body 320. Thus, an elongated shaft 46 can be inserted into the elongated body 320 through the opening 332. The ends 333 of the retainer 331 may be bent outwards to allow the elongated shaft 46 to be inserted into a channel within the elongated body 320. The ends 333 may then be bent inwards toward the elongated shaft 46 to grip the elongated shaft 46 within the channel. The ends 333 may form arms that overlap a portion of the elongated shaft 46 to retain the elongated shaft 46 through the channel of the elongated body 320. (As shown in...) Figure 53 As shown, the ends 333 of the retainer 331 may be spaced apart from each other, or in an embodiment may be in contact with each other.

[0244] To remove the elongated shaft 46 from the resilient retainer 331, the elongated shaft 46 can be pulled out from the elongated opening 332. The end 333 can be bent outward to allow the elongated shaft 46 to exit the channel of the elongated body 320. Other retainers 331 used with the elongated body 320 can each be similarly configured and operate in a similar manner.

[0245] The retainer 331 may be flexible to allow the end 333 to bend outwards and inwards. The retainer 331 may also be flexible to allow the retainer 331 to cushion the elongated shaft 46 from forces that may be applied to the elongated body 320. The retainer 331 may be made of an elastic material that can be configured to return to its original shape after deformation. The material of the retainer 331 may be a rubber material, or in embodiments, various elastic polymers, or other materials as needed. One or more retainers 331 may be configured to be injection molded onto one or more desired portions of the elongated body 320, such as the ends 324, 329, or intermediate portions of the elongated body 320. In embodiments, the configuration of the retainer 331 can be... Figure 52 and Figure 53 The configuration changes shown are illustrated.

[0246] Other devices and methods may be used to couple the delivery device 44 to the elongated body 320 as needed.

[0247] In operation, when the delivery device 44 is provided to a user who can prepare for or otherwise use the delivery device 44, the elongated body 320 can be packaged to be coupled to the delivery device 44. For example, Figure 48 An elongated body 320 coupled to a delivery device 44 is shown, wherein an elongated shaft 46 is positioned within a channel 322 of the elongated body 320. The elongated body 320 is in an extended configuration, wherein the elongated shaft 46 is also in an extended configuration. The delivery device 44 can be provided to a user, wherein the elongated body 320 is located thereon and both are in an extended configuration.

[0248] It may be desirable for the user to position the distal end of the elongated shaft 46 and the implant holding region 54 close to the handle 52 and control mechanism of the delivery device 44. Such a feature can be advantageous, for example, if the user wishes to perform an operation at the distal end of the delivery device 44 while controlling the control mechanism. For instance, if a curling operation is performed at the distal end of the delivery device 44, the user may wish to control... Figure 5 The outer sheath 64 is positioned to cover or remove all or part of the balloon 58 or implant 10. In embodiments, the user may additionally wish to bring the proximal end of the delivery device 44 close to the distal end of the delivery device 44.

[0249] The elongated body 320 can be used to assist the user in bending the elongated shaft 46, thereby bringing the distal end of the delivery device 44 closer 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 to pull the ends 324, 329 together. The elongated body 320 is bent in at least one plane to bend the elongated shaft of the delivery device, thereby positioning the distal portion of the delivery device closer to the proximal portion of the delivery device. The elongated body 320 can be drawn from... Figure 48 The straightening configuration shown is moved to, as Figure 49 The curved or sloping configuration is shown. The size of the cutout portion 326 can be reduced, and the opposing surfaces 328 can contact each other. The elongated opening 332 ( Figure 45 The elongated shaft 46 (marked out) can be completely or partially closed to enclose the elongated shaft 46 within the channel 322. In embodiments, the elongated shaft 46 can be coupled to the elongated body 320 using other devices or methods, such as as... Figure 46 and Figure 47 The couplings shown are as well as other forms of couplings.

[0250] The elongated body 320 can be held in a curved or curved configuration by means of a coupling 334 extending between the ends 324, 329 of the elongated body 320. One or more couplings can engage between portions of the elongated body 320 to maintain the curved configuration of the elongated body 320. The coupling 334 can position the elongated body 320 and the elongated shaft 46 in a curved or curved configuration.

[0251] In a curved or flexed configuration, the user can view the distal end of the delivery device 44 while simultaneously manually operating the controls at the handle 52. The proximity of the handle 52 to the distal end allows for easy operation at the distal end. Curling operations or other operations can be performed at the distal end. For example, the distal end of the delivery device 44 can be inserted into the channel 90 of the curling device 84, and the implant 10 can be curled into the implant holding region 54. The curling procedure can include curling procedures as disclosed herein or other forms of curling procedures.

[0252] In the desired operation performed on the distal end of the delivery device 44, the delivery device 44 can be released from the elongated body 320. For example, the coupling 334 can be released, and the elongated shaft 46 can be straightened. The elongated shaft 46 can then be removed from the channel 322 of the elongated body 320. The delivery device 44 can then be prepared for insertion into a part of the patient's body, or another operation can be performed on the delivery device 44.

[0253] The elongated body 320 advantageously allows the ends of the delivery device 44 to be effectively brought close together. This proximity allows for more efficient operation on the ends of the delivery device. The elongated body 320 can be packaged on the elongated shaft 46 of the delivery device 44 for easy packaging and delivery to the user. The elongated body 320 can be detached and discarded after use.

[0254] Figure 50A variation of the elongated body 346 is shown, wherein couplings configured to hold the elongated body 346 in a curved configuration may include multiple couplings in the form of pins 352 configured to engage holes 354. Pins 352 may be coupled to one side of the cut-out portion 356, and holes 354 may be coupled to the other side. Pins 352 may be configured to engage holes 354 in a ratchet manner, wherein pins 352 include barbs or another configuration that allows pins 352 to engage holes 354. When the elongated body 346 moves into a curved or curved configuration, as... Figure 51 As shown, pin 352 can engage hole 354 to hold elongated body 346 in a bent or curved configuration. Other coupling configurations can be used as needed.

[0255] The elongated body can be used alone or in combination with other components disclosed herein. The configuration of the elongated body can be varied in the embodiments.

[0256] Figure 57 A side view of a curling system that can be used in the embodiments herein is shown. The curling system can be used for prosthetic implants. According to the embodiments herein, the curling system can utilize curling device 400 to curl the implant.

[0257] The coiling device 400 may include a plurality of elongated strands 402, each elongated strand 402 having a first end 404 (in Figure 58 (shown in the cross-sectional view) and the second end 406 (in Figure 58 (As shown in the cross-sectional view). Reference Figure 58 Cross-sectional view, multiple slender strands 402 ( Figure 58 The exemplary strands 402a, 402b in the example can be arranged to form an elongated tube 408 that extends about an axis 410 and surrounds a channel 412 configured to receive an implant, and has a central portion 414 with an inner diameter 416.

[0258] In one embodiment, the crimping device 400 may include a first support body 417, which may be coupled to a first end 404 of each of a plurality of elongated strands 402. The crimping device 400 may include a second support body 419, which may be coupled to a second end 406 of each of the plurality of elongated strands 402 and may be configured to rotate about an axis 410 relative to the first support body 417 to reduce the inner diameter 416 and compress the prosthetic implant within the channel 412.

[0259] refer to Figure 57The elongated strand 402 may include a string-like or linear body, each body having a length greater than the diameter of the corresponding strand 402. The strand 402 may have a circular cross-section, or may be provided as a flat strip, or may have another configuration as needed.

[0260] Each of the strands 402 may be configured to be flexible in embodiments and, in some embodiments, to be longitudinally stretched. In embodiments, the strands 402 may be configured to be longitudinally stretched, which may allow the ends of the strands 402 to rotate relative to each other. In embodiments, the degree of stretching may be at least 5%, 7%, 10%, or greater or less, as needed. The elongated strands 402 may each comprise a single strand body or comprise multiple strand bodies that can be configured to flex.

[0261] The elongated strand 402 can be made of a polymeric material (such as nylon or other forms of polymer) or a metal (such as stainless steel or nitinol or other metals, or other metals as needed). The elongated strand 402 may be textured or provided with a friction coating to improve the grip of the implant in embodiments. In embodiments, the elongated strand 402 may be coated with a lubricating coating, for example, to minimize the possibility of damage to the implant and improve the ability of a portion of the delivery device (such as a sheath) to contact and slide against the strand 402. Other forms of the elongated strand 402 may be used in embodiments.

[0262] Multiple slender strands 402 can be arranged to form a slender tube 408, the multiple slender strands 402 being circumferentially spaced from each other, such as Figure 57 and Figure 59 As shown. For example, the first ends 404 of the slender strands 402 can each be coupled to the first support body 417 with circumferential spacing between them (e.g., Figure 59 (As shown). The first end 404 can be arranged in a ring. The spacing can be the same between the ends 404 of the elongated strand 402, or in an embodiment, the spacing can be different. The second end 406 of the elongated strand 402 can each be aligned with... Figure 59 A similar arrangement is shown where the elongated strand 402 is coupled to the second support body 419 at opposite ends. The second end 406 can be arranged in a ring.

[0263] The arrangement of the ends 404, 406 of the slender strand 402 can form an elongated tube 408 between the ends 404, 406. For example, the elongated tube 408 can have the following characteristics: Figure 57 and Figure 59 The cylindrical configuration shown may be used, or other configurations may be used in the embodiments, such as rectangular or triangular configurations.

[0264] The number of elongated strands 402 can be varied in the embodiments. For example... Figure 57 and Figure 59 As shown, the number of long, thin strands can be thirty-six, but in some embodiments, a larger or smaller number can be used. For example, the number of long, thin strands can be 10 or more, 20 or more, 30 or more, or a larger or smaller amount as needed. In an embodiment, the number of long, thin strands can be greater than 50.

[0265] refer to Figure 58 The first ends 404 of a plurality of elongated strands 402 may be arranged to form an opening 420 for a channel 412. The second ends 406 of the plurality of elongated strands 402 in the embodiment may be further arranged to form an opening 422 for a channel 412. One or more openings 420, 422 may allow an object, such as a prosthetic implant, to pass through and enter the channel 412 for coiling.

[0266] The first ends 404 of the plurality of elongated strands 402 may also be arranged to have a diameter 424. The diameter 424 may include the diameter of the opening 420 in the embodiment. The second ends 406 of the plurality of elongated strands 402 in the embodiment may be further arranged to have a diameter 426. The diameter 426 may include the diameter of the opening 422 in the embodiment. One or more diameters 424, 426 in the embodiment may be configured to be smaller than the length 427 of the elongated tube 408. Therefore, the elongated strands 402 can form an elongated structure, which can also be configured to accommodate an elongated implant and provide for an elongated sheath (e.g., Figure 65 (As shown) the ability to enter channel 412 and capture coiled implants. The ratio of diameters 424, 426 to length 427 of elongated tube 408 can provide improved coiling and capture of coiled implants during coiling. The relative proportions of elongated tube 408 may vary in embodiments from those shown herein.

[0267] Support bodies 417, 419 can be positioned at the ends 404, 406 of a plurality of elongated strands 402. One or more of the support bodies 417, 419 may include corresponding openings 428, 430 that lead to corresponding openings 420, 422 of the plurality of elongated strands 402. In embodiments, the support bodies 417, 419 can have various forms, including, Figures 57 to 60The ring-shaped body shown, or other configurations such as a lever arm or mechanical actuator, or other configurations as required. Support bodies 417, 419 may include corresponding gripping portions 432, 434 that allow gripping of support bodies 417, 419 during use. Gripping portions 432, 434 may be gripped as needed to allow support bodies 417, 419 to rotate relative to each other. In embodiments, gripping may include manual gripping. For example, a user may grip one or more gripping portions 432, 434 and rotate one or more support bodies 417, 419 relative to each other. In embodiments, gripping may be provided using tools.

[0268] In an embodiment, the retainer body 436 may be coupled to the first support body 417 and the second support body 419. The retainer body 436 may include a central body located between the first support body 417 and the second support body 419. The retainer body 436 may define a certain distance between the first support body 417 and the second support body 419 (corresponding to...). Figure 58 (Length 427 shown). The retainer body 436 may include a housing that holds the components of the curling device 400 together. Figure 57 and Figure 59 The multiple openings shown allow observation of the interior of the retainer body 436.

[0269] The retainer body 436 may have a first portion 438 coupled to a first support body 417 and a second portion 440 coupled to a second support body 419. In an embodiment, the retainer body 436 may include a tube with an internal cavity for retaining a plurality of elongated strands 402 therein, or may have another configuration as needed.

[0270] In an embodiment, the retainer body 436 may define a stationary distance between the first support body 417 and the second support body 419. For example, as Figures 57 to 59 As shown, the retainer body 436 can be rigid, thus maintaining the relative positions of the first support body 417 and the second support body 419. For example... Figure 66 In the illustrated embodiment, the retainer body may have a length that varies to provide a variable distance between the first support body and the second support body.

[0271] One or more of the first support body 417 or the second support body 419 can be configured to rotate relative to the retainer body 436. For example, as Figure 58As shown, the first support body 417 and the second support body 419 can be coupled to the retainer body 436 via corresponding rotary couplings 442, 444, which allow rotation about axis 410. For example, each rotary coupling 442, 444 may include a bearing surface that allows rotation. The retainer body 436 can maintain the distance between the first support body 417 and the second support body 419 during rotation in an embodiment. In an embodiment, one of the first support body 417 or the second support body 419 can be configured to rotate relative to the retainer body 436, while the other support body remains fixed in place relative to the retainer body 436. Therefore, in such an embodiment, the user can rotate only one of the support bodies 417, 419. Various other configurations of the retainer body can be used as needed.

[0272] Multiple slender strands 402 can be configured to rotate from an extended configuration to a diameter-reducing configuration. The extended configuration can... Figures 57-62 As shown in the diagram. In the extended configuration, channel 412 can be used to insert an implant. In the extended configuration, as... Figures 57-60 As shown, each first end 404 of the elongated strand 402 can be circumferentially aligned with a corresponding one of the second ends 406 of the elongated strand 402. For example, Figure 59 This arrangement is shown. The slender strand 402 can extend parallel to the axis 410. Figure 60 Including along Figure 57 A cross-sectional view of the coiling device 400 for the thread AA. The elongated strand 402 is shown extending parallel to the axis 410.

[0273] refer to Figure 58 In the extended configuration, the inner diameter 416 of the central portion 414 of the elongated tube 408 can be the largest. The inner diameter 416 of the central portion 414 can be the same as the diameters 424, 426 of the ends 404, 406 of the strand 402. In embodiments, the extended configuration may include some rotation of the first end 404 of the elongated strand 402 relative to the second end 406. For example, Figure 61 An extended configuration with some rotation of the first end 404 of the elongated strand 402 relative to the second end 406 is shown.

[0274] In the extended configuration, the implant can be inserted into channel 412. For example, Figure 61 An implant 450 is shown located within channel 412 (with a frame for the implant 450 shown, and other features of the implant 450 excluded from view for clarity). The implant 450 may preferably be positioned at the central portion 414 of the elongated tube 408.

[0275] Figure 62A cross-sectional view of the implant 450 located within the channel 412 is shown. The implant 450 can be axially aligned within the channel 412, such as... Figure 61 and Figure 62 As shown. In embodiments, the implant 450 can be inserted into a channel 412 through one of the openings 420, 422 of a plurality of elongated strands 402, and through one of the openings 428, 430 of the support bodies 417, 419. In embodiments where the implant 450 is to be positioned on a portion of a delivery device (such as a balloon), the portion of the delivery device can extend as needed through the channel 412 from one opening 422 to another opening 420. Thus, as may be disclosed herein, the openings 420, 422 of the channel 412 can allow an elongated shaft of the delivery device to pass through as needed. The elongated shaft of the delivery device from Figure 61 and Figure 62 Excluded from the view.

[0276] exist Figure 61 and 62 In the configuration shown, one or more of the support bodies 417, 419 can rotate relative to each other to rotate a plurality of elongated strands 402. The second support body 419 can rotate relative to the first support body 417 about axis 410 to reduce the inner diameter 416 and compress the implant 450 within the channel 412. The plurality of elongated strands 402 can be rotated to a diameter-reducing configuration. The ends 404, 406 of the plurality of elongated strands 402 can rotate relative to each other. The plurality of elongated strands 402 can be wound in the diameter-reducing configuration.

[0277] For example, Figure 63 and Figure 64 Multiple elongated strands 402 are shown in a diameter-reducing configuration. The multiple elongated strands 402 and elongated tubes 408 form a hyperbola or hourglass shape, wherein the inner diameter 416 is reduced and the corresponding diameter 424 at the first end 404 and the diameter 426 at the second end 406 are larger than the inner diameter 416.

[0278] Each of the plurality of elongated strands 402 can rotate the circumferential position of the first end 404 relative to the second end 406, such that each strand rotates about axis 410 and extends laterally relative to axis 410. Given that the length 427 of the elongated tube 408 remains constant, as... Figure 64 As shown, the strand 402 can be stretched longitudinally to allow the circumferential position of the first end 404 to rotate relative to the second end 406.

[0279] Figure 64 A schematic cross-sectional view of the coiling device 400 is shown, illustrating the outline of the strand 402, but individual strands are not shown. Figure 64As shown, when the plurality of elongated strands 402 are in a decreasing diameter configuration, the plurality of elongated strands 402 can form a first funnel 452, which extends radially outward from the central portion 414 toward a first segment 404 of the plurality of elongated strands 402. When the plurality of elongated strands 402 are in a decreasing diameter configuration, the plurality of elongated strands 402 can form a second funnel 454, which extends radially outward from the central portion 414 toward a second end 406 of the plurality of elongated strands 402. Each funnel can have a truncated conical shape, having a wide portion directed away from the central portion 414 of the elongated tube 408 and a narrow portion at the central portion 414. Other configurations of the funnels can be produced as needed.

[0280] As the multiple elongated strands 402 contact and press radially inward against the implant 450, the central portion 414 can apply compressive force to the implant 450. Therefore, the central portion 414 can coil the implant 450. The central portion 414 can have a cylindrical shape positioned between the funnels 452 and 454, caused by the deflection of the elongated strands 402 by the implant 450 at the central portion 414.

[0281] In an embodiment, the implant 450 may be configured to elongate and axially extend in response to radial compressive forces applied to the implant 450 via a plurality of elongated strands 402. For example, the diameter of the implant may be reduced, and the length of the implant may be increased accordingly. Figure 63 and Figure 64 The length of the implant 450 shown has been increased. The ends 460, 462 of the implant 450 in the embodiment can remain within the channel 412 and can be positioned within the corresponding funnels 452, 454.

[0282] In one embodiment, the implant 450 can be Figure 64 In the illustrated configuration, the implant is coiled to the elongated shaft of the delivery device. For example, the elongated shaft of the delivery device may pass through channel 412, and the implant may be coiled to the elongated shaft (e.g., a balloon-inflatable implant may be coiled to an inflatable balloon). Implant 450 may be coiled to the implant holding region of the elongated shaft. However, in the embodiment, in... Figure 64 In the configuration shown, a portion of the delivery device can be inserted into channel 412 to couple to and extend thereon the coiled implant 450.

[0283] For example, Figure 65A sheath 461 of the delivery device is shown that can be inserted into a channel 412 and pass over an implant 450 compressed within the channel 412. In an embodiment, the sheath 461 may include a capsule for holding the implant 450 prior to deployment. For example, the capsule may cover the implant 450 during delivery and may include an implant holding region of the delivery device. In embodiments, other forms of sheaths may be used to capture the implant, such as loaders for loading implants into delivery devices or other equipment.

[0284] When the multiple slender strands are in a decreasing diameter configuration, the multiple slender strands 402 can be stretched radially outward from the central portion 414, and the sheath passes over the implant 450 (e.g., Figure 65 (As indicated by the radially outward-pointing arrow). When the multiple elongated strands are in a decreasing diameter configuration, the strands 402 can be stretched radially outward from the central portion 414 to allow the sheath 461 to extend over the outer surface of the implant 450. The sheath 461 can contact the strands 402 and press them radially outward. The sheath 461 can slide between the strands 402 and the outer surface of the implant 450.

[0285] The sheath 461 can extend over the entire coiled implant 450 to capture the implant 450, and can then be removed and retracted from the channel 412, in which the implant 450 is located. In this way, the implant 450 can be captured in a coiled state by the sheath 461 in a single coiling operation. Other features of the delivery device (such as a guide spool or nose cone) can pass through the channel 412 and may exit from the outlet 422 in embodiments if desired.

[0286] A funnel 452 formed by multiple elongated strands 402 can be configured to receive a sheath 461 for extending onto a prosthetic implant. The funnel 452 can guide the sheath 461 to capture the implant 450. For example, the funnel 452 can be deflected and oriented towards the implant 450 to improve each capture of the coiled implant 450.

[0287] In one embodiment, implant 450 may include a mechanical frame having multiple struts connected by rotatable hinges. Implant 450 may include a mechanically expandable implant. For example, Figures 68A-68C An exemplary configuration of an implant with a mechanical frame is shown. The implant with the mechanical frame can expand due to the operation of the mechanical components. Examples of such implants are disclosed in U.S. Patent No. 9,913,716, filed January 24, 2017, and granted March 13, 2018, the entire contents of which are incorporated herein by reference. Figures 72, 77, and 81 of U.S. Patent No. 9,913,716 are reproduced herein. Figures 68A-68CThe implant may include a prosthetic heart valve replacement assembly 572, a stent grid 574, a graft fence 576, a jack assembly 578, transplant material 580, valve leaflets 582, and a synaptic plate 584. The frame may include multiple struts. Figure 68B Remove the cover to reveal multiple supports 586. The multiple supports 586 can be connected by rotatable hinges. Figure 68C The implant with the cap removed and in a compressed state is shown. Figure 68C As shown, the coiling device disclosed herein can be used to move the implant into a compressed state. The implant can then be expanded at the desired location within the patient's body using mechanical components.

[0288] The use of a mechanical frame allows the entire frame to curl due to compression of individual sections or the middle portion of the implant. For example, see reference. Figure 64 The ends 460, 462 of the implant 450 can protrude from the central portion 414, and because the central portion 464 has been compressed by multiple elongated strands 402, the ends 460, 462 of the implant 450 can be in a compressed state. Therefore, only a portion of the implant 450 needs to be subjected to compressive force to produce a curled state for the entire implant 450. The protruding ends 460, 462 of the implant 450 can be easily captured by a portion of a delivery device (such as a sheath 461), such as... Figure 65 As shown. The implant 450 can be configured to have an increase in length in response to radial compression of the implant 450.

[0289] In embodiments, other forms of implants can be used and coiled, including self-expanding implants, balloon-expandable implants, and other forms of expandable implants. Implants coiled with the coiling device 400 can include implants that can be biased to expand when the compressive force of the coiling device is removed. For example, mechanically expandable implants can expand upon removal of compressive force, which may make it difficult to capture such implants within the sheath of the delivery device. Thus, when the sheath captures these implants, they can be advantageously held in a compressed state, such as... Figure 65 As shown. For example, during implant capture, compressive force can be maintained on the implant to reduce the likelihood of radial outward expansion of the implant. This can result in a simplified coiling and capture process. In embodiments, other forms of implants may be used in the embodiments described herein. The implants used may be intended for deployment to the aortic valve, mitral valve, tricuspid valve, or pulmonary valve, as well as other deployment sites. In embodiments, the implant may include a replacement heart valve. The implant may include leaflets and other components, such as one or more skirts disclosed herein. Other forms of implants may be used as needed.

[0290] In embodiments, an insert may be used that has a mechanical frame similar to that of implant 450. For example, the insert may include multiple struts connected by rotatable hinges. The insert may be configured to curl due to compression of a single portion or intermediate portion of the insert. The insert may be configured to receive a prosthetic implant within the insert. For example, the implant may include a self-expanding or balloon-expandable implant that may have a plastically deformable frame. The insert may have an implant positioned therein. An insert with an implant positioned therein may be positioned within channel 412 and curled by curling device 400. Thus, a central force applied by curling device 400 to a single portion of a single insert may cause the entire insert to curl. The insert may compress the implant radially, and thus the entire implant may curl along its length.

[0291] Variations of the curling device 400 can be provided. For example, Figure 66 One embodiment is shown in which the retainer body 470 is configured to have a length 472 that can vary to provide a variable distance between a first support body 417 and a second support body 419. For example, the retainer body 470 may include a length-varying body, such as a piston 474 and / or a spring 476, to allow for variation in length 472. In such an embodiment, the plurality of elongated strands 480 may have a fixed length and may be non-stretchable. The distance between the support bodies 417, 419 can vary to allow the plurality of elongated strands 480 to rotate during relative rotation of the support bodies 417, 419. Other forms of length-varying bodies or combinations of length-varying bodies may be used as needed.

[0292] Figure 67 An embodiment is shown in which the length-changing body includes a portion of an elongated strand 490. The length-changing body may include a body such as a piston 492 or a spring 494 to allow the length of the elongated strand 490 to change. Thus, in this embodiment, the first portion of the elongated strand may be stretchable, and the second portion may be non-stretchable. The length of the retainer body 436 may remain constant.

[0293] In one embodiment, during manufacturing, multiple elongated strands can be formed and coupled to a support body in a separate step. In another embodiment, the multiple elongated strands can be integrally formed with a first support body and / or a second support body. For example, the support body and the multiple elongated strands can be formed in a mold, such as a single mold, and can be integral with each other. Injection molding can be used. Therefore, this can potentially reduce manufacturing complexity. Various other manufacturing methods can be used as needed.

[0294] The curling systems and apparatus disclosed herein can be used alone or in combination with other embodiments disclosed herein.

[0295] Implants and devices that are coiled or otherwise prepared can be used to treat a part of a patient's body. Such treatment may include implantation of the implant as well as other procedures.

[0296] As discussed, various forms of implants can be used with the embodiments disclosed herein, including prosthetic heart valves, or other forms of implants such as stents or filters, or diagnostic devices, etc. Implants can be expandable implants configured to move from a compressed or undeployed state to an expanded or deployed state. Implants can be compressible implants configured to be compressed inward to have a reduced external profile and to move the implant to a compressed or undeployed state. Coiling devices as disclosed herein can facilitate moving implants to a compressed or undeployed state.

[0297] The delivery devices disclosed herein can also be used in aortic, mitral, tricuspid, and pulmonary valve replacement and repair procedures. Delivery devices may also include delivery devices for other forms of implants, such as stents or filters, or diagnostic devices, etc.

[0298] The delivery devices and systems disclosed herein can be used in transcatheter aortic valve implantation (TAVI) or to replace other natural heart valves (e.g., mitral, tricuspid, or pulmonary valves). The delivery devices and systems disclosed herein can be used for transarterial access (including via the femoral artery) to a patient's heart. The delivery devices and systems can be used for percutaneous transcatheter procedures, including transarterial procedures, which can be via the femoral artery or via the vein. Transapical procedures, etc., can also be used. Other procedures can be used as needed.

[0299] Features of the embodiments can be modified, replaced, excluded, or combined as needed.

[0300] Furthermore, the methods described herein are not limited to those specifically described, and may include methods utilizing the systems and apparatus disclosed herein. Modifications, exclusions, or additions to the methods can be made using the systems, apparatus, and methods disclosed herein.

[0301] The features of the embodiments disclosed herein can be implemented independently of the curling device or other components disclosed herein. Various devices of the system can be implemented independently.

[0302] Finally, it should be understood that although various aspects of this specification are highlighted with reference to specific embodiments, those skilled in the art will readily understand that these disclosed embodiments are merely illustrative of the principles of the subject matter disclosed herein. Therefore, it should be understood that the disclosed subject matter is by no means limited to the specific methods, schemes, and / or reagents described herein. Thus, various modifications, alterations, or alternative configurations of the disclosed subject matter can be made based on the teachings herein without departing from the spirit of this 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, apparatuses, and methods disclosed herein, which are defined only by the claims. Therefore, the systems, apparatuses, and methods are not limited to those specifically shown and described in the figures.

[0303] This document describes certain embodiments of systems, apparatuses, and methods, including the best modes known to the inventors for implementing these systems, apparatuses, and methods. Of course, variations of these described embodiments will become apparent to those skilled in the art upon reading the foregoing description. The inventors expect those skilled in the art to use these variations appropriately, and anticipate systems, apparatuses, and methods practiced in other ways besides those specifically described herein. Therefore, systems, apparatuses, and methods include all modifications and equivalents of the subject matter set forth in the appended claims, as permitted by applicable law. Furthermore, unless otherwise stated herein or otherwise contradicted by the context, any combination of the above embodiments is included in all possible variations of the systems, apparatuses, and methods.

[0304] The grouping of alternative embodiments, elements, or steps of systems, apparatuses, and methods is not to be construed as limiting. Each member of a group may be mentioned and claimed individually or in combination with other members of the groups disclosed herein. It is contemplated that one or more members of a group may be included in the group or removed for convenience and / or patentability reasons. When any such inclusion or removal occurs, the specification is deemed to include the group as amended, thereby satisfying the written description of all marked groups used in the appended claims.

[0305] Unless otherwise stated, all figures expressing features, items, quantities, parameters, properties, terms, etc., as used in this specification and claims should be understood to be modified in all cases by the term "about". As used herein, the term "about" means that a qualified feature, item, quantity, parameter, property, or term contains an approximation that may vary but is capable of performing the desired operation or process discussed herein.

[0306] The terms “a,” “an,” “the,” and similar designations used in the context of describing systems, apparatuses, and methods (particularly in the context of the appended claims) are to be interpreted to cover both singular and plural forms, unless otherwise stated herein or obviously contradicted by the context. All methods described herein may be performed in any suitable order unless otherwise stated herein or otherwise contradicted by the context. The use of any and all example or exemplary language (e.g., “such as”) provided herein is intended only to better elucidate the systems, apparatuses, and methods and does not limit the scope of any additionally claimed systems, apparatuses, and methods. No language in this specification should be construed as indicating that any non-protective element is necessary for the practice of the systems, apparatuses, and methods.

[0307] All patents, patent publications, and other publications referenced and acknowledged in this specification are hereby individually and expressly incorporated herein by reference for purposes of description and disclosure, in their entirety (e.g., possibly in conjunction with systems, apparatus, and methods, the compositions and methods described in those publications). These publications were only disclosed prior to the filing date of this application. Nothing in this regard should be construed as an admission that the inventor was not entitled to such prior disclosure due to prior invention or for any other reason. All statements regarding the dates or representations of the contents of these documents are based on information available to the applicant and do not constitute any admission of the accuracy of the dates or contents of these documents.

[0308] The following are some exemplary, non-limiting embodiments:

[0309] Example 1. A system for rolling a prosthetic implant having one or more leaflets into a delivery device, the system comprising:

[0310] A support body is configured to be inserted into a curling device and has a support surface configured to be positioned between the one or more leaflets and the delivery device and to support the one or more leaflets in an open position.

[0311] Example 2. The system according to Example 1, wherein the support surface has a tapered shape.

[0312] Example 3. The system according to Example 1 or 2, wherein the support surface has a conical shape.

[0313] Example 4. The system according to any one of Examples 1-3, wherein the support body includes a central channel configured to allow the delivery device to extend through it.

[0314] Example 5. The system according to Example 4, wherein the support surface extends around the central channel.

[0315] Example 6. The system according to any one of Examples 1-5, wherein the support body extends from a first end to a second end, and the first end includes an alignment device for rotatably aligning the support body with the curling device.

[0316] Example 7. The system according to Example 6, wherein the support surface is tapered downward in the direction toward the second end.

[0317] Example 8. The system according to any one of Examples 1-7, wherein the support body is configured to slide axially away from the prosthetic implant when the curling device curls the prosthetic implant.

[0318] Example 9. The system according to any one of Examples 1-8, wherein the support body is configured to be inserted into the channel of the curling device and slide axially away from the channel when the curling device curls the prosthesis implant.

[0319] Example 10. The system according to any one of Examples 1-9, wherein the support body is configured to be inserted into the distal opening of the curling device.

[0320] Example 11. The system according to any one of Examples 1-10, wherein the support body is configured to be inserted into the proximal opening of the curling device.

[0321] Example 12. The system according to any one of Examples 1-11 further includes the curling device, the curling device including one or more pressing surfaces configured to radially compress the prosthetic implant and surround a channel configured to receive the prosthetic implant, the support body and the delivery device.

[0322] Example 13. The system according to Example 12, wherein the curling device includes a proximal opening and a distal opening, the proximal opening being configured to allow the delivery device to be inserted and pass through the channel, and the distal opening being configured to allow the support body to be inserted and pass through the channel.

[0323] Example 14. The system according to Example 12 or 13, wherein the curling device includes a proximal opening and a distal opening, the proximal opening being configured to allow the support body to be inserted through the channel, and the proximal opening being configured to allow the support body to be inserted through the channel.

[0324] Example 15. The system according to any one of Examples 12-14, wherein the support body is configured to be releasably coupled to the curling device and slide axially away from the channel when the curling device curls the prosthesis implant.

[0325] Example 16. The system according to any one of Examples 12-15, wherein the support body is configured to slide in a distal direction axially away from the channel when the curling device curls the prosthesis implant.

[0326] Example 17. The system according to any one of Examples 12-16, wherein the support body is configured to slide in a proximal direction axially away from the channel when the curling device curls the prosthetic implant.

[0327] Example 18. The system according to any one of Examples 1-17 further includes the prosthetic implant, wherein the prosthetic implant includes a frame coupled to the one or more leaflets and configured to be radially compressed and axially elongated while being radially compressed.

[0328] Example 19. The system according to Example 18, wherein the support surface is configured to slide axially relative to the one or more leaflets.

[0329] Example 20. The system according to any one of Examples 1-19 further includes the delivery device, wherein the delivery device is configured to be positioned within the curling device, and wherein the support surface extends around the delivery device.

[0330] Example 21. The system according to Example 20, wherein the delivery device includes an elongated shaft configured to be positioned within the winding device.

[0331] Example 22. The system according to Example 20 or 21, wherein the delivery device includes a balloon for the prosthetic implant to be rolled up thereon.

[0332] Example 23. The system according to any one of Examples 1-22 further includes an alignment guide, the alignment guide including one or more indicators indicating the rotational position of the prosthetic implant on the support body.

[0333] Example 24. The system according to Example 23, wherein the alignment guide includes a ring configured to be coupled to the support body.

[0334] Example 25. The system according to Example 23 or 24, wherein the one or more indicators are configured to indicate the position of one or more junctures of the one or more leaflets.

[0335] Example 26. A system for rolling a prosthetic implant having one or more leaflets into a delivery device, the system comprising:

[0336] A ring-shaped body, the ring-shaped body including one or more indicators indicating the rotational position of the prosthetic implant relative to the ring-shaped body.

[0337] Example 27. The system according to Example 26, wherein the one or more indicators are configured to indicate the position of one or more junctures of the one or more leaflets.

[0338] Example 28. The system according to Example 26 or 27, wherein the annular body includes a first surface, a second surface opposite to the first surface, and an outer surface connecting the first surface to the second surface, and the one or more indicators are positioned on one or more of the first surface, the second surface, or the outer surface.

[0339] Example 29. The system according to any one of Examples 26-28, wherein the one or more indicators comprise a plurality of indicators circumferentially spaced apart from each other.

[0340] Example 30. The system according to Example 28 or 29, wherein the annular body includes an inner surface facing away from the outer surface and surrounding a central channel of the annular body.

[0341] Example 31. The system according to any one of Examples 26-30, wherein the one or more indicators include one or more marks on the annular body.

[0342] Example 32. The system according to Example 31, wherein the one or more marks include variations in the surface profile of the annular body.

[0343] Example 33. The system according to any one of Examples 26-32, wherein the annular body includes a first arm and a second arm, wherein the first arm is coupled to the second arm at a pivot.

[0344] Example 34. The system according to Example 33, wherein the first arm includes a first end and a second end located at the pivot, the second arm includes a first end and a second end located at the pivot, and the second ends of the first arm and the second arm are configured to be coupled to each other.

[0345] Example 35. The system according to Example 33 or 34 further includes a first rod extending from the first arm and a second rod extending from the second arm, the first rod and the second rod being configured to be pressed to rotate the first arm or the second arm about the pivot.

[0346] Example 36. The system according to any one of Examples 26-35, wherein the annular body is configured to be coupled to the support body, the support body being configured to be inserted into the curling device and having a support surface, the support surface being configured to be positioned between the one or more leaflets and the delivery device for supporting the one or more leaflets in an open position.

[0347] Example 37. The system according to Example 36 further includes a coupling member configured to rotatably align the annular body with the support body.

[0348] Example 38. The system according to Example 36 or 37 further includes the support body, wherein the annular body is configured to extend around the support body.

[0349] Example 39. The system according to any one of Examples 36-38, wherein the annular body is configured to abut against the prosthetic implant when the prosthetic implant is positioned on the support body.

[0350] Example 40. The system according to any one of Examples 36-39, wherein the annular body includes a spacer configured to define the position of the prosthetic implant on the support body.

[0351] Example 41. A method comprising:

[0352] The delivery device is positioned within the channel of a curling device, the curling device including one or more pressing surfaces configured to radially compress the prosthetic implant within the channel;

[0353] The prosthetic implant is positioned within the channel and around the delivery device, the prosthetic implant comprising one or more leaflets;

[0354] The support body is positioned within the channel and between the one or more leaflets and the delivery device;

[0355] The support body supports the one or more leaflets in the open position; and

[0356] The prosthetic implant is rolled into the delivery device using one or more pressing surfaces of the rolling device.

[0357] Example 42. The method according to Example 41, wherein curling the prosthetic implant into the delivery device includes holding the one or more leaflets in the open position.

[0358] Example 43. The method according to Example 41 or 42 further includes axially sliding the support body away from the prosthetic implant within the channel.

[0359] Example 44. The method according to Example 43 further includes sliding the support body axially in a distal direction away from the prosthetic implant within the channel.

[0360] Example 45. The method according to Example 43 further includes sliding the support body axially in a proximal direction away from the prosthetic implant within the channel.

[0361] Example 46. The method according to any one of Examples 41-45, wherein the support body includes a support surface having a tapered shape, and rolling the prosthesis implant into the delivery device includes applying force to the support surface through the pressing surface to cause the support body to slide axially away from the prosthesis implant within the channel.

[0362] Example 47. The method according to any one of Examples 41-46 further includes positioning the prosthetic implant on the support body.

[0363] Example 48. The method according to Example 47 further includes inserting a prosthetic implant into a distal opening of the curling device.

[0364] Example 49. The method according to Example 47 further includes inserting the prosthetic implant into the proximal opening of the curling device.

[0365] Example 50. The method according to any one of Examples 47-49, wherein the support body includes a support surface having a tapered shape with a wide portion and a narrow portion, and positioning the prosthesis implant on the support body includes positioning the prosthesis implant on the support body such that the one or more leaflets open in a direction from the wide portion toward the narrow portion.

[0366] Example 51. The method according to any one of Examples 41-50 further includes bringing the prosthetic implant against the annular body to define the position of the prosthetic implant on the support body.

[0367] Example 52. The method according to Example 51, wherein the annular body includes one or more indicators indicating the rotational position of the prosthetic implant relative to the annular body.

[0368] Example 53. The method according to Example 52, wherein the one or more indicators are configured to indicate the position of one or more junctures of the one or more leaflets.

[0369] Example 54. The method according to Example 52 or Example 53 further includes aligning the one or more couplings with the one or more indicators.

[0370] Example 55. The method according to any one of Examples 51-54 further includes removing the annular body from the support body before rolling the prosthetic implant into the delivery device.

[0371] Example 56. A system for rolling a prosthetic implant into a delivery device, the system comprising:

[0372] A stop housing includes a cavity and a contact surface, the cavity being configured to receive a portion of the delivery device distal to the implant holding region of the delivery device, and the contact surface being configured to abut against the delivery device to impede axial distal movement of the delivery device when the delivery device is positioned within a curling device, wherein the curling device is configured to curl the prosthetic implant into the delivery device.

[0373] Example 57. The system according to Example 56, wherein the contact surface includes the inner surface of the cavity.

[0374] Example 58. The system according to Example 57, wherein the inner surface of the cavity is angled.

[0375] Example 59. The system according to any one of Examples 56-58, wherein the contact surface conforms to the shape of the delivery device.

[0376] Example 60. The system according to any one of Examples 56-59, wherein the contact surface conforms to the shape of the distal end of the delivery device.

[0377] Example 61. The system according to any one of Examples 56-60, wherein the cavity is configured to receive the distal shoulder of the delivery device, the delivery device being located distal to the implant retention region of the delivery device.

[0378] Example 62. The system according to any one of Examples 56-61, wherein the stop housing is configured to be coupled to the coiling device.

[0379] Example 63. The system according to any one of Examples 56-62 further includes the curling device, the curling device including one or more pressing surfaces configured to radially compress the prosthetic implant and surround the channel, the channel being configured to receive the prosthetic implant and the delivery device.

[0380] Example 64. The system according to Example 63, wherein the curling device includes a proximal opening and a distal opening, the proximal opening being configured to allow the delivery device to be inserted and pass through the channel, and the stop housing being configured to be positioned at the distal opening.

[0381] Example 65. The system according to Example 64, wherein the channel is configured to advance the delivery device axially distally toward the distal opening.

[0382] Example 66. The system according to any one of Examples 63-65, wherein the contact surface is configured to abut against the delivery device to impede axial distal movement of the delivery device within the channel to define the position of the delivery device within the channel, and wherein the distal shoulder of the delivery device is positioned distal to the channel.

[0383] Example 67. The system according to any one of Examples 56-66 further includes the delivery device, wherein the delivery device is configured to be positioned within the curling device.

[0384] Example 68. The system according to Example 67, wherein the delivery device includes an elongated shaft configured to be positioned within the coiling device.

[0385] Example 69. The system according to Example 67 or Example 68, wherein the delivery device includes a balloon for the prosthetic implant to be rolled thereon.

[0386] Example 70. The system according to any one of Examples 56-69 further includes the prosthetic implant, wherein the prosthetic implant includes a frame coupled to one or more leaflets and configured to compress radially and extend axially while being compressed radially.

[0387] Example 71. A method comprising:

[0388] The delivery device is positioned within the channel of a curling device, the curling device including one or more pressing surfaces configured to radially compress the prosthetic implant within the channel;

[0389] Position the prosthetic implant within the channel and around the delivery device;

[0390] The portion of the delivery device distal to the implant holding region abuts against the stop housing to define the position of the delivery device within the channel of the curling device; and

[0391] The prosthetic implant is rolled into the delivery device using one or more pressing surfaces of the rolling device.

[0392] Example 72. The method according to Example 71, wherein the delivery device includes a distal shoulder located distal to the implant holding region, and the distal shoulder is positioned outside the channel when the prosthetic implant is rolled into the delivery device.

[0393] Example 73. The method according to Example 71 or 72, wherein the delivery device includes an elongated shaft configured to be positioned within the coiling device.

[0394] Example 74. The method according to any one of Examples 71-73, wherein the delivery device includes a balloon for the prosthetic implant to be rolled up thereon.

[0395] Example 75. The method according to any one of Examples 71-74, wherein the curling device includes a proximal opening and a distal opening, the proximal opening being configured to allow a delivery device to be inserted and pass through the channel.

[0396] Example 76. The method according to Example 75 further includes axially advancing the delivery device toward the distal opening through the channel.

[0397] Example 77. The method according to any one of Examples 71-76, wherein the stop housing is positioned on the distal side of the channel.

[0398] Example 78. The method according to any one of Examples 71-77, wherein the stop housing is coupled to one side of the coiling device on the distal side of the channel.

[0399] Example 79. The method according to any one of Examples 71-78, wherein the stop housing includes a contact surface configured to be part of the delivery device adjacent to the distal side of the implant retention region, the contact surface conforming to the shape of the delivery device.

[0400] Example 80. The method according to any one of Examples 71-79, wherein the prosthetic implant includes a frame coupled to one or more leaflets and configured to compress radially and elongate axially while being compressed radially.

[0401] Example 81. A system for rolling a prosthetic implant into a delivery device, the system comprising:

[0402] A spacer body configured to extend on a portion of the delivery device distal to the implant holding region of the delivery device and including a contact surface for abutting the distal end of the prosthetic implant to define the position of the prosthetic implant on the delivery device.

[0403] Example 82. The system according to Example 81, wherein the spacer body includes a cavity for receiving a portion of the delivery device distal to the implant retention region.

[0404] Example 83. The system according to Example 81 or Example 82, wherein the spacer body includes a cavity for receiving the distal end of the delivery device.

[0405] Example 84. The system according to Example 83, wherein the distal portion of the spacer body includes a cavity for receiving the distal end of the delivery device, and the proximal portion of the spacer body includes the contact surface.

[0406] Example 85. The system according to Example 83 or 84, wherein the spacer body includes an opening for viewing a distal end positioned in the cavity for receiving the distal end of the delivery device.

[0407] Example 86. The system according to any one of Examples 81-85, wherein the contact surface is a first contact surface, and the spacer body includes a second contact surface configured to adjoin the distal end of the delivery device.

[0408] Example 87. The system according to any one of Examples 81-86, wherein the spacer body is configured to extend over the distal shoulder of the delivery device on the distal side of the implant holding region.

[0409] Example 88. The system according to any one of Examples 81-87, wherein the contact surface extends about the longitudinal axis of the spacer body.

[0410] Example 89. The system according to Example 88, wherein the contact surface extends transversely to the longitudinal axis.

[0411] Example 90. The system according to any one of Examples 81-89, wherein the spacer body includes a cavity for receiving the prosthetic implant.

[0412] Example 91. The system according to Example 90, wherein the spacer body includes an opening for viewing the prosthetic implant positioned within the cavity, the cavity being for receiving the prosthetic implant.

[0413] Example 92. The system according to any one of Examples 81-91 further includes a curling device comprising one or more pressing surfaces configured to radially compress the prosthetic implant and surround a channel configured to receive the prosthetic implant and the delivery device.

[0414] Example 93. The system according to Example 92, wherein the curling device includes a proximal opening and a distal opening, the proximal opening being configured to allow the delivery device to be inserted into and pass through the channel, and the spacer body being configured to be positioned at the distal opening.

[0415] Example 94. The system according to Example 93, wherein the curling device includes a distal side at the distal opening, the distal side being configured to adjoin a proximal portion of the spacer body.

[0416] Example 95. The system according to any one of Examples 81-94 further includes the delivery device, wherein the delivery device includes a balloon for the prosthetic implant to be rolled thereon.

[0417] Example 96. A method comprising:

[0418] Position the spacer body on a portion of the delivery device distal to the implant retention area of ​​the delivery device;

[0419] Position the prosthesis implant on the delivery device;

[0420] The distal end of the prosthetic implant is abutted against the contact surface of the spacer body to define the position of the prosthetic implant on the delivery device; and

[0421] The prosthetic implant is rolled into the delivery device at the appropriate position.

[0422] Example 97. The method according to Example 96, wherein positioning the spacer body over the portion of the delivery device includes inserting the delivery device into a cavity of the spacer body.

[0423] Example 98. The method according to Example 96 or 97 further includes viewing the distal end of the delivery device within the cavity of the spacer body through an opening in the spacer body.

[0424] Example 99. The method according to any one of Examples 96-98, wherein abutting the distal end of the prosthetic implant against the contact surface of the spacer body comprises inserting the prosthetic implant into a cavity of the spacer body.

[0425] Example 100. The method according to any one of Examples 96-99 further includes viewing the prosthetic implant within the cavity of the spacer body through an opening in the spacer body.

[0426] Example 101. The method according to any one of Examples 96-100 further includes curling a portion of the prosthesis implant into the delivery device before abutting the distal end of the prosthesis implant against the contact surface of the spacer body.

[0427] Example 102. The method according to any one of Examples 96-101, wherein curling the prosthetic implant at the appropriate location into the delivery device comprises positioning the spacer body distal to the channel of the curling device.

[0428] Example 103. The method according to Example 102, wherein the delivery device includes a distal shoulder positioned distal to the implant holding region, the distal shoulder being positioned outside the channel when the prosthetic implant is rolled into the delivery device.

[0429] Example 104. The method according to Example 102 or 103 further includes abutting the spacer body against the distal side of the curling device as the prosthetic implant is curled into the delivery device.

[0430] Example 105. The method according to any one of Examples 96-104 further includes removing the spacer body from the delivery device.

[0431] Example 106. A system comprising:

[0432] An elongated body comprising a channel for receiving an elongated shaft of a delivery device having a proximal portion and a distal portion, the elongated body being configured to bend in at least one plane such that the distal portion of the delivery device is close to the proximal portion of the delivery device.

[0433] Example 107. The system according to Example 106, wherein the elongated body includes a proximal end and a distal end, and includes a sleeve configured to extend along the elongated axis.

[0434] Example 108. The system according to Example 106 or Example 107, wherein the elongated body is configured to bend from a straight configuration to a bent configuration.

[0435] Example 109. The system according to Example 108, wherein the elongated body has a “U” shape in the curved configuration.

[0436] Example 110. The system according to Example 108 or Example 109 further includes one or more couplings configured to hold the elongated body in the curved configuration.

[0437] Example 111. The system according to Example 110, wherein the one or more coupling elements include a tether configured to couple a proximal end of the elongated body to a distal end of the elongated body.

[0438] Example 112. The system according to Example 111, wherein the tether is configured to maintain the distance between the proximal end of the elongated body and the distal end of the elongated body.

[0439] Example 113. The system according to any one of Examples 106-112, wherein the elongated body includes a plurality of slit portions located on one side of the elongated body, wherein one side of the elongated body forms an inner curve when the elongated body is bent.

[0440] Example 114. The system according to Example 113, wherein each of the plurality of cut portions has a wedge shape.

[0441] Example 115. The system according to Example 113 or 114, wherein the opposing surfaces of each of the plurality of cut portions are configured to contact each other to define the radius of curvature of the elongated body.

[0442] Example 116. The system according to any one of Examples 106-115 further includes an elongated opening extending on one side of the elongated body, wherein one side of the elongated body forms an outer curve when the elongated body is bent.

[0443] Example 117. The system according to Example 116, wherein the size of the elongated opening is configured to decrease when the elongated body is bent.

[0444] Example 118. The system according to any one of Examples 106-117 further includes a plurality of couplings configured to hold the elongated body in a curved configuration.

[0445] Example 119. The system according to any one of Examples 106-118, wherein the elongated body is configured to be separate from the elongated shaft.

[0446] Example 120. The system according to any one of Examples 106-119 further includes the delivery device, wherein the proximal portion of the delivery device includes a handle and the distal portion of the delivery device includes an implant retention region.

[0447] Example 121. A method comprising:

[0448] An elongated body, including a channel for receiving a delivery device, is bent in at least one plane to bend the elongated shaft, thereby positioning the distal portion of the delivery device closer to the proximal portion of the delivery device.

[0449] Example 122. The method according to Example 121 further includes engaging one or more couplings between portions of the elongated body to maintain the curved configuration of the elongated body.

[0450] Example 123. The method according to Example 122 further includes bending the elongated body from the straight configuration to the bent configuration.

[0451] Example 124. The method according to Example 122 or Example 123, wherein the elongated body has a “U” shape in the curved configuration.

[0452] Example 125. The method according to any one of Examples 121-124, wherein the delivery device is packaged to be coupled to the elongated body.

[0453] Example 126. The method according to any one of Examples 121-125 further includes removing the elongated body from the elongated axis of the delivery device.

[0454] Example 127. The method according to any one of Examples 121-126, wherein the elongated body includes a plurality of slit portions located on one side of the elongated body, and one side of the elongated body forms an inner curve when the elongated body is bent.

[0455] Example 128. The method according to Example 127 further includes bringing the opposing surfaces of the plurality of cut portions into contact when the elongated body is bent.

[0456] Example 129. The method according to any one of Examples 121-128, wherein the proximal portion of the delivery device includes a handle, and the distal portion of the delivery device includes an implant retention region.

[0457] Example 130. The method according to Example 129 further includes curling the prosthetic implant into the implant holding region of the delivery device when the elongated body is bent, and positioning the distal portion of the delivery device close to the proximal portion of the delivery device.

[0458] Example 131. A curling system for prosthetic implants, the curling system comprising:

[0459] Multiple slender strands, each having a first end and a second end and arranged to form an elongated tube extending around an axis and surrounding a channel configured to receive a prosthetic implant, and having a central portion with an inner diameter;

[0460] A first support body, coupled to the first end of each of the plurality of elongated strands; and

[0461] A second support body, coupled to the second end of each of the plurality of elongated strands, is configured to rotate about an axis relative to the first support body to reduce the inner diameter and compress the prosthetic implant within the channel.

[0462] Example 132. The coiling system according to Example 131, wherein the first ends of the plurality of elongated strands are arranged to have a diameter smaller than the length of the elongated tube.

[0463] Example 133. A coiling system according to Example 131 or Example 132, wherein the second ends of the plurality of elongated strands are arranged to have a diameter smaller than the length of the elongated tube.

[0464] Example 134. A coiling system according to any one of Examples 131-133, wherein the first or second end of the plurality of elongated strands is arranged to form an opening for the prosthetic implant to pass through and enter the channel.

[0465] Example 135. A coiling system according to any one of Examples 131-134, wherein the plurality of elongated strands are configured to rotate from an extended configuration to a diameter-reducing configuration.

[0466] Example 136. A crimping system according to Example 135, wherein in the extended configuration each of the first ends of the plurality of elongated strands is circumferentially aligned with a corresponding one of the second ends of the plurality of elongated strands.

[0467] Example 137. A coiling system according to Example 135 or Example 136, wherein the plurality of elongated strands are twisted in a diameter-reducing configuration.

[0468] Example 138. A coiling system according to any one of Examples 135-137, wherein the plurality of elongated strands are configured to be stretched radially outward from the central portion when the plurality of elongated strands are in a diameter-reducing configuration.

[0469] Example 139. A coiling system according to any one of Examples 135-138, wherein the plurality of elongated strands form a first funnel, the first funnel extending radially outward from the central portion toward the first end of the plurality of elongated strands when the plurality of elongated strands are in a diameter-reducing configuration.

[0470] Example 140. The coiling system according to Example 139, wherein the plurality of elongated strands form a second funnel that extends radially outward from the central portion toward the second end of the plurality of elongated strands when the plurality of elongated strands are in a diameter-reducing configuration.

[0471] Example 141. A coiling system according to Example 139 or 140, wherein the first funnel is configured to receive a sheath of a delivery device when the plurality of elongated strands are in a diameter-reducing configuration, the sheath of the delivery device being used to extend over the prosthetic implant positioned at the central portion.

[0472] Example 142. The coiling system according to Example 141, wherein the plurality of elongated strands are configured to extend radially outward from the central portion when the plurality of elongated strands are in a diameter-reducing configuration to allow the sheath to extend over the prosthetic implant.

[0473] Example 143. A coiling system according to any one of Examples 131-142, wherein each of the plurality of elongated strands is configured to be stretched longitudinally.

[0474] Example 144. The curling system according to any one of Examples 131-143 further includes a retainer body coupled to the first support body and the second support body and defining a distance between the first support body and the second support body.

[0475] Example 145. The curling system according to Example 144, wherein the retainer body is positioned between the first support body and the second support body, and defines a stationary distance between the first support body and the second support body.

[0476] Example 146. The curling system according to Example 144, wherein the retainer body is positioned between the first support body and the second support body and is configured to vary in length to provide a variable distance between the first support body and the second support body.

[0477] Example 147. The curling system according to any one of Examples 131-146 further includes a prosthetic implant, and said prosthetic implant includes a frame having a plurality of struts connected by rotatable hinges.

[0478] Example 148. A curling system according to Example 147, wherein the prosthetic implant is configured to increase in length in response to radial compression of the prosthetic implant.

[0479] Example 149. The curling system according to any one of Examples 131-148 further includes an insert configured to be positioned within the channel and to receive the prosthetic implant, the insert comprising a frame having a plurality of struts connected by rotatable hinges.

[0480] Example 150. A coiling system according to any one of Examples 131-149, wherein the plurality of elongated strands are integrally formed with the first support body and the second support body.

[0481] Example 151. A method comprising:

[0482] Positioning the prosthesis implant within the channel of the curling device, the curling device comprising:

[0483] Multiple slender strands, each having a first end and a second end, are arranged to form an elongated tube extending around an axis and surrounding a channel, and have a central portion with an inner diameter.

[0484] A first support body coupled to a first end of each of the plurality of elongated strands, and

[0485] A second support body coupled to the second end of each of the plurality of elongated strands; and

[0486] The second support body is rotated about an axis relative to the first support body to reduce the inner diameter and compress the prosthetic implant within the channel.

[0487] Example 152. The method according to Example 151, wherein the first ends of the plurality of elongated strands are arranged to have a diameter smaller than the length of the elongated tube.

[0488] Example 153. The method according to Example 151 or 152, wherein the first or second end of the plurality of elongated strands is arranged to form an opening for the prosthetic implant to pass through and enter the channel.

[0489] Example 154. The method according to any one of Examples 151-153, wherein the plurality of elongated strands are rotated from the extended configuration to the diameter-reduced configuration.

[0490] Example 155. The method according to Example 154, wherein the plurality of elongated strands are twisted in a diameter-reducing configuration.

[0491] Example 156. The method according to Example 154 or Example 155, wherein the plurality of elongated strands form a first funnel that extends radially outward from the central portion toward the first end of the plurality of elongated strands when the plurality of elongated strands are in a diameter-reducing configuration.

[0492] Example 157. The method according to any one of Examples 154-156 further includes passing the sheath of the delivery device over the prosthetic implant compressed within the channel.

[0493] Example 158. The method according to Example 157, wherein the plurality of elongated strands are stretched radially outward from the central portion as the sheath passes over the prosthetic implant.

[0494] Example 159. The method according to any one of Examples 151-158, wherein each of the plurality of elongated strands is longitudinally stretched when the second support body rotates relative to the first support body about the axis.

[0495] Example 160. The method according to any one of Examples 151-159, wherein the prosthetic implant includes a frame having a plurality of struts connected by rotatable hinges.

Claims

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

2. The system of claim 1, wherein the support surface has a conical shape.

3. The system of claim 1 or 2, further comprising the crimping apparatus, the crimping apparatus comprising one or more pressing surfaces configured to radially compress the prosthetic implant and surround a passage configured to receive the prosthetic implant, the support body, and the delivery device.

4. The system of claim 3, wherein the support body is configured to be releasably coupled to the crimping apparatus and to slide in an axial direction away from the passage as the crimping apparatus crimps the prosthetic implant.

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