System and method for holding artificial implants

Abstract

Devices, systems, and methods for holding an artificial implant. The systems in certain embodiments may be used to hold an artificial implant prior to implantation in a patient's body and prior to coupling to a delivery device used to implant the artificial implant in a patient's body. Certain embodiments disclosed herein may relate to devices, systems, and methods for preparing an artificial implant prior to implantation.

Description

Technical Field

[0001] Cross - Reference to Related Applications This application claims the benefit of U.S. Provisional Patent Application No. 63 / 140,004, filed on January 21, 2021, the entire contents of which are incorporated herein by reference.

Background Art

[0002] Certain embodiments disclosed herein may relate to devices, systems, and methods for holding an artificial implant. The system in certain embodiments may be used to hold an artificial implant before transplantation into a patient's body and before coupling to a delivery device used to transplant the artificial implant into the patient's body. Certain embodiments disclosed herein may relate to devices, systems, and methods for preparing an artificial implant before transplantation.

[0003] Human heart valves include the aortic valve, pulmonary valve, mitral valve, and tricuspid valve and essentially function as one - way valves that operate in synchronization with the heartbeat of the heart. The valves allow blood to flow downstream but block blood from flowing upstream. Diseased heart valves exhibit disorders such as stenosis or regurgitation of the valve, inhibiting the ability to control the blood flow through the valve. Such disorders can reduce the blood - pumping efficiency of the heart and lead to debilitating and life - threatening conditions. For example, valve insufficiency can lead to conditions such as heart hypertrophy and ventricular dilation. Therefore, extensive efforts have been made to develop methods and devices for repairing or replacing diseased heart valves.

[0004] Prostheses exist to correct problems associated with heart valve dysfunction. For example, mechanical and tissue-based heart valve prostheses can be used to replace a faulty native heart valve. In recent years, considerable effort has been made to develop replacement heart valves, especially tissue-based replacement heart valves, which can be delivered with less trauma to the patient than open cardiac surgery. Replacement valves are designed to be delivered through minimally invasive procedures, and even percutaneous procedures. These replacement valves often consist of a tissue-based valve body that is connected to an expandable frame and then delivered to the annulus of the native valve.

[0005] It has been demonstrated that the development of prostheses, including replacement heart valves, that are miniaturized for delivery and then controllably expandable for controlled placement, is particularly challenging. Delivery devices may be provided to deploy such implants to desired locations within the human body. The implant may be in a compressed state when coupled to the delivery device and therefore must be compressed for delivery to the desired location of the implant within the patient's body. The implant may be crimped to the delivery device before the delivery device is inserted into the patient's body.

[0006] These implants may be transported to the clinician for use by the clinician to crimp the implant to a delivery device before it is implanted in the patient's body. It is preferable that the implants are not damaged during transport to the clinician and when they are removed from their containers before the crimping procedure. While methods exist for transporting such implants, it may be desirable to provide improved devices, systems, and methods for use in holding the implants and preparing other devices. [Overview of the Initiative] [Problems that the invention aims to solve]

[0007] Embodiments of this disclosure may relate to devices, systems, and methods for holding artificial implants. Systems in certain embodiments may be used to hold artificial implants before implantation into a patient's body and before attachment to a delivery device used to implant the artificial implant into the patient's body. Certain embodiments disclosed herein may relate to devices, systems, and methods for preparing artificial implants prior to implantation. [Means for solving the problem]

[0008] In embodiments, the artificial implant may include an implantable artificial valve. In embodiments, the implantable artificial valve may include an implantable artificial heart valve. In embodiments, the implantable artificial heart valve may be configured to replace or repair the patient's own aortic valve, pulmonary valve, mitral valve, or tricuspid valve. Other forms of implantable artificial valves may be used in embodiments.

[0009] One or more embodiments of the present disclosure include a holder system for an implantable prosthetic valve. The system may include a holder body and one or more releasable couplers coupled to the holder body and configured to hold an implantable prosthetic valve in the holder body. The system may include an actuator coupled to the holder body and configured to operate to release one or more releasable couplers from the implantable prosthetic valve.

[0010] One or more embodiments of the present disclosure include a method, which may include coupling an implantable artificial valve to one or more releasable couplers of a holder, the holder including a holder body coupled to one or more releasable couplers, and an actuator coupled to the holder body and configured to operate to release one or more releasable couplers from the implantable artificial valve.

[0011] One or more embodiments of the present disclosure include a method, which may include operating an actuator of a holder to release an implantable artificial valve from one or more releasable couplers of the holder, the holder including one or more releasable couplers and a holder body coupled to the actuator.

[0012] The features and advantages of the systems, apparatus, and methods disclosed herein will become more apparent as they are better understood by referring to this specification, the claims, and the accompanying drawings. [Brief explanation of the drawing]

[0013] [Figure 1] Figure 1 illustrates a side perspective view of an artificial implant according to an embodiment of the present disclosure. [Figure 2] Figure 2 illustrates a top view of the artificial implant shown in Figure 1, with the implant's valve leaflets in the closed position. [Figure 3] Figure 3 illustrates a top view of the artificial implant shown in Figure 1, with the implant's valve leaflets in an open position. [Figure 4] Figure 4 illustrates a side view of a delivery device according to an embodiment of the present disclosure. [Figure 5] Figure 5 illustrates a detailed view of a portion of a delivery device according to an embodiment of the present disclosure. [Figure 6] Figure 6 illustrates a rear perspective view of a crimping device according to an embodiment of the present disclosure. [Figure 7] Figure 7 illustrates a front perspective view of the crimping device shown in Figure 6. [Figure 8] Figure 8 shows a perspective view of an artificial implant holder coupled to the artificial implant frame according to an embodiment of the present disclosure. [Figure 9] Figure 9 shows a side view of the holder shown in Figure 8. [Figure 10] Figure 10 shows a top view of the holder shown in Figure 8. [Figure 11]FIG. 11 shows a bottom perspective view of the holder shown in FIG. 8 with the artificial device excluded from the figure. [Figure 12] FIG. 12 shows a bottom view of the holder body shown in FIG. 8. [Figure 13] FIG. 13 shows a top perspective view of the actuator shown in FIG. 8. [Figure 14] FIG. 14 shows a bottom perspective view of the actuator shown in FIG. 8. [Figure 15] FIG. 15 shows a cross-sectional view of the holder and the artificial implant along line A-A shown in FIG. 10. [Figure 16] FIG. 16 shows a cross-sectional view of the holder and the artificial implant along line A-A shown in FIG. 10, with the actuator in a state of having moved from the position shown in FIG. 15. [Figure 17] FIG. 17 shows a perspective view of the holder shown in FIG. 8 coupled to the retainer. [Figure 18] FIG. 18 shows a perspective view of the holder, retainer, and artificial implant shown in FIG. 17 disposed within the container. [Figure 19] FIG. 19 shows a perspective view of the lid coupled to the container shown in FIG. 18. [Figure 20] FIG. 20 shows a cross-sectional view along line B-B shown in FIG. 19 of the holder, retainer, and artificial implant positioned within the container shown in FIG. 18.

MODE FOR CARRYING OUT THE INVENTION

[0014] Figure 1 shows a perspective view of an artificial implant 10 in the form of a transplantable artificial valve. The transplantable artificial valve of the embodiment may include a replacement heart valve. The artificial implant 10 may be configured to be deployed within a portion of a patient's body. The artificial implant 10 may be deployed, for example, within a native heart valve annulus having a native aortic valve, or in an embodiment, may have a native mitral valve, tricuspid valve, or pulmonary valve. In an embodiment, the artificial implant 10 may have other forms and may include a stent or other forms of medical implants as desired. The artificial implant may be configured to replace or repair a portion of a patient's body.

[0015] The artificial implant 10 may include a proximal end 12 and a distal end 14, and a length therebetween. The artificial implant 10 may include a body in the form of a frame 16. The artificial implant 10 may further include one or more of a plurality of valve leaflets 18a - c coupled to the frame 16 and may include a skirt 20 that covers an outer surface of a distal portion of the frame 16.

[0016] The frame 16 may include a plurality of struts 22 connected at joints 24. A plurality of openings 26 may be positioned between the struts 22. The openings 26 may be configured to reduce the overall weight of the frame 16 and also enable the frame 16 to be compressed to reduce its diameter and expanded to increase its diameter. The frame 16 may be configured to be radially compressed and to become axially longer while being radially compressed. The struts 22 may be configured such that when the frame 16 is compressed to reduce its diameter, the length of the frame 16 may increase. Also, as the frame 16 is expanded to increase its diameter, the length of the frame 16 may decrease. The frame 16 may be compressed in various manners including the use of a crimping device and may be expanded in various manners including being expanded by a balloon, being self - expandable, or being mechanically expandable.

[0017] The frame 16 may include an outer surface 28 configured to press against the internal vascular system of the patient's body. For example, when the frame 16 is expanded, the outer surface 28 may come into contact with and press against the internal vascular system of the patient's body. In embodiments, the outer surface 28 may press against the annulus or leaflets of a heart valve. The frame 16 may include an inner surface 30 (marked in Figure 2) configured to face the opposite side of the outer surface 28 and to face the flow path of the implant 10.

[0018] The skirt 20 may cover the outer surface 28 of the distal portion of the frame 16, as shown in Figure 1, and may include a membrane or other form of skirt 20. The skirt 20 may improve the frame 16's conformity to the progenitor valve into which the implant 10 is implanted, and may be used to connect the valve leaflets 18a-c to the frame 16 via sutures of another form of connector.

[0019] Multiple valve leaflets 18a-c (clearly shown in Figure 2) may extend inward from the inner surface 30 of the frame 16. Multiple valve leaflets 18a-c may be configured to move toward each other to move to a closed position (shown in Figure 2) and away from each other to move to an open position (shown in Figure 3). Each valve leaflet 18a-c may include upper end portions 32a-c (marked in Figure 3) configured to contact each other to close the flow path of the implant 10 when the valve leaflets 18a-c are in the closed position. The upper end portions 32a-c are configured to move away from each other to open the flow path of the implant 10 when the valve leaflets 18a-c are in the open position. The valve leaflets 18a-c may move back and forth between open and closed positions or states or configurations to replicate the movement of the self-valving valve.

[0020] Each valve leaflet 18a-c may include an inner surface 34a-c (marked in Figure 3) configured to face the flow path of the implant 10, and an outer surface 36a-c (marked in Figure 2) facing the opposite side of the inner surface 34a-c and away from the flow path 37 of the implant 10. The portions of the inner surface 34a-c of each valve leaflet 18a-c may come into contact with each other when the valve leaflets 18a-c move to the closed position.

[0021] Each valve leaflet 18a-c may include its respective outer portion 38a-c (marked in Figure 2) which connects to the frame 16 of the implant 10. The connection can take various forms. For example, each valve leaflet 18a-c may include tabs 40a-f on its respective outer portion 38a-c. Tabs 40a,b may extend from valve leaflet 18a, tabs 40c,d may extend from valve leaflet 18b, and tabs 40e,f may extend from valve leaflet 18c. Tabs 40a-f may extend through openings in the frame 16 to connect to the frame 16, and then may be sutured to hold tabs 40a-f in place. Tabs 40a-f may form commissures of adjacent valve leaflets 18a-c.

[0022] Furthermore, the outer portions 38a-c of each valve leaflet 18a-c can be sutured to the skirt 20 along suture lines 42a-c. For example, the lower portion of each valve leaflet 18a-c opposite the upper portion 32a-c can be sutured to the skirt 20 along their respective suture lines 42a-c. The suturing along suture lines 42a-c can hold the valve leaflets 18a-c to the frame 16 and prevent undesirable fluid flow through the implant 10 outside the flow path 37.

[0023] The valve leaflets 18a-c may be configured to open and close during operation such that the proximal end 12 of the implant 10 forms the outflow end of the implant 10 and the distal end 14 of the implant 10 forms the inflow end of the implant 10. The valve leaflets 18a-c may be configured to obstruct the fluid flow in the opposite direction from the outflow end to the inflow end of the implant 10 when the valve leaflets 18a-c are in the closed position.

[0024] In embodiments, other forms of implants, such as stents or other forms of medical devices, may be used. The implant configurations shown in Figures 1 to 3 may be modified in embodiments.

[0025] The implant 10 may be configured to be delivered to the implantation site using a delivery device. Figure 4 illustrates an embodiment of a delivery device 44 that may be used, for example, to deliver the implant 10 to a desired implantation site. 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 retention area 54 and a distal tip which may include a nose cone 56. The distal portion 48 may further include an inflatable body in the form of a balloon 58. The delivery device 44 may be configured to be positioned within a crimping device to crimp the implant 10 into the implant retention area 54. The elongated shaft 46 may be positioned within the crimping device. The balloon 58 may be configured on which the implant 10 is crimped. In embodiments, other forms of deployment mechanisms may be used to deploy the implant (e.g., a self-expanding implant or a mechanically expandable implant).

[0026] Figure 5 illustrates an enlarged view of the distal portion 48 of the elongated shaft 46. The implant retention area 54 may be configured so that the implant 10 is pressed onto the balloon 58 and positioned within the intermediate portion 82 between the distal shoulder 76 and the proximal shoulder 78 of the balloon 58. In certain embodiments, the outer sheath 64 may advance distally to cover the implant 10 positioned within the implant retention area 54 when the implant 10 is pressed. In embodiments, the configuration of the delivery device may be modified from the configuration shown in Figures 4 and 5.

[0027] The implant 10 can be crimped to the implant retention area 54 in various ways. Figure 6 illustrates, for example, a rear perspective view (or a view from the proximal side of the crimping device 84) of the crimping device 84. The crimping device 84 may include a base 86, an actuator in the form of a handle 88, and an opening 96 leading to a channel 90 into which the implant 10 and delivery device 44 are inserted. The crimping device 84 may further include a rotatable body 98 configured to rotate with the rotation of the handle 88. The crimping device 84 may be configured to operate by a plurality of pressing surfaces 100 surrounding the channel 90 and central axis 102 and to apply a compressive force to compress the implant 10 positioned within the channel 90 radially. Accordingly, the implant 10 positioned within the channel 90 will be compressed against the implant retention area 54 within the channel 90 due to the radial compressive force of the pressing surfaces 100 on the implant.

[0028] Figure 7 illustrates a front perspective view (or a distal view) of the crimping device 84. The crimping device 84 may include a distal surface 104 that includes a distal opening 106 leading into the channel 90. The distal opening 106 may be configured to allow a portion of the delivery device 44 to pass through while the crimping operation is being performed by the crimping device 84. The configuration of the crimping device may be modified in embodiments as desired.

[0029] The implant 10 may be transported before being implanted in the patient's body, or it may be transported before a crimping procedure in which the implant 10 can be crimped to the delivery device 44 by the crimping device 84. In embodiments, the holder system may be used to hold the implant 10 and may also be used to transport the implant 10. In embodiments, the holder system may be used to store the implant 10.

[0030] Figure 8 shows an embodiment of a holder 110 that may be used in embodiments of this specification. The holder 110 may include a holder body 112, one or more releasable couplers 114, and an actuator 116. The implant 10 is coupled to the holder 110 and shown with only the frame 16 of the implant 10 visible. In Figures 8, 9, and 15-20, features such as the valve leaflets 18a-c and skirt 20 have been excluded from the figures for clarity.

[0031] The holder body 112 may include a central portion 118 and one or more grip portions 120 that may extend radially outward from the central portion 118. The grip portions 120 may have one or more arms that may extend circumferentially around the central portion 118. For example, as shown in Figure 8, the support 122 for the grip portions 120 may extend proximal to the proximal surface 124 of the central portion 118. The grip portions 120 may be positioned radially outward from the proximal surface 124 of the central portion 118.

[0032] In this embodiment, the support 122 may be in the form of a column, as shown in Figure 8. The proximal portion of the support 122 may be connected to the grip portion 120 and support the grip portion 120 at a certain distance from the proximal surface 124 of the central portion 118.

[0033] The grip portion 120 in the form of an arm may extend circumferentially between the support members 122, or it may connect the proximal portions of the support members 122 to each other. The grip portion 120 in the form of an arm may extend circumferentially around the central portion 118 and form a ring positioned radially outward from the central portion 118.

[0034] In the embodiment, one or more other forms of grip portions may be used.

[0035] The opening 126 may be located between the grip portion 120 and the central portion 118, and in embodiments, between adjacent support members 122. The opening 126 may extend radially outward from the central portion 118, as shown in Figures 8 and 10, and may be sized to allow gripping of the grip portion 120. For example, the grip portion 120 may be configured to be grasped by a hand or a device such as a clamp (such as a hemostatic forceps or another form of clamp). The opening 126 may be sized so that fingers of a hand or a clamp are positioned around the grip portion 120, allowing gripping of the holder body 112. The outer surface 128 of the grip portion 120 may have a grip surface configured to be grasped by a hand or device to hold the holder body 112.

[0036] The central portion 118 of the holder body 112 may include a proximal surface 124 and may include a central opening 130 (shown more clearly in Figure 12). The proximal surface 124 may have a flat surface through which the support 122 protrudes proximally. The central opening 130 may be configured to be accessed by a user through which a portion of the actuator 116 passes.

[0037] Referring to Figure 9, the holder body 112 may include a proximal portion 132 and a distal portion 134. In embodiments, the proximal portion 132 may include a grip portion 120 and a support 122. In other embodiments, other features of the holder body 112 may include the proximal portion 132 of the holder body 112. The distal portion 134 may be for contacting the implant 10 and may include a central portion 118 in embodiments, but in other embodiments, other features of the holder body 112 may include the distal portion 134.

[0038] The distal portion 134 shown in Figure 9 may have a cylindrical shape defined by the outer surface 136 of the holder body 112. The opening 126 may pass through the distal portion 134 to allow gripping of the grip portion 120. Both the proximal portion 132 and the distal portion 134 may form a "T" shape relative to the holder body 112, as shown in Figure 9, but in embodiments, a completely cylindrical shape or other shapes (e.g., triangle, square, ellipse, etc.) may be used as desired. In one embodiment where a "T" shape is used, with the grip portion 120 extending radially outward from the distal portion 134 as shown in Figure 9, the user can more easily grasp the grip portion 120 to hold the holder body 112 and operate the actuator 116.

[0039] The distal portion 134 may include one or more channels 138 within its outer surface 136, which can allow the arm 140 of the actuator 116 to pass through. The channels 138 may be used to guide the arm 140 of the actuator 116 and reduce the possibility of rotation of the actuator 116 during the sliding motion of the actuator 116.

[0040] Figure 10 shows a top view of the holder body 112. The grip portion 120 is shown extending radially outward from the central portion 118.

[0041] Figure 11 shows a bottom perspective view of the holder body 112 with the implant 16 removed from the figure. The distal portion 134 of the holder body 112 is shown including a central cavity 142 for receiving the actuator 116. The central cavity 142 may be defined by the inner surface 144 of the holder body 112 facing the opposite side of the outer surface 136 and facing the central cavity 142. One or more guide supports 146 may be positioned within the central cavity 142 and may extend distally from the central surface 148 of the holder body 112 facing the opposite side of the proximal surface 124 shown in Figure 8. The guide supports 146 may be positioned between the arms 140 of the actuator 116 and may be configured to guide the arms 140 of the actuator 116 to reduce the possibility of rotation of the actuator 116 during the sliding motion of the actuator 116. The guide supports 146 may have an arc shape as shown in Figure 11, or may have another shape as desired. The arm 140 of the actuator 116 may slide between the guide supports 146.

[0042] The distal portion 134 of the holder body 112 may include a receiving portion 139 configured to receive the implant 10, particularly the end portion 12 of the implant 10. The end portion 12 may be the proximal end facing the skirt 20, as shown in Figure 1, or it may be the proximal end portion 32a-c of the valve leaflets 18a-c. The implant 10 may be positioned within the receiving portion 139 such that the implant 10 extends axially and distally to the holder 110.

[0043] The receiving portion 139 may include a recess 150 for receiving a portion of the implant 10. The recess 150 may be defined by a lip 152 extending circumferentially around the holder body 112 and a distally facing contact surface 154. The lip 152 may extend distally from the contact surface 154 and may be configured to reduce the possibility of the implant 10 slipping or otherwise moving relative to the holder body 112 when coupled to the holder body 112.

[0044] The contact surface 154 may be configured to contact a portion of the implant 10, which may be the proximal end 12 of the implant. The contact surface 154 can support the implant 10 when it is coupled to one or more releasable couplers 114.

[0045] Figure 12 shows a bottom view of the holder body 112 with the actuator 116 removed from the diagram. Various other configurations of the holder body may be used in the embodiment as desired. For example, certain features of the holder body 112 may be excluded, added, or replaced with other features as desired.

[0046] Referring to Figure 11, one or more releasable couplers 114 may be coupled to the holder body 112, or may be configured to hold the implant 10 in the holder body 112. One or more releasable couplers 114 may include an elongated arm that may extend distally from the central surface 148, as shown in Figure 11. The releasable coupler 114 may extend along a channel 138 of the holder body 112, for example, as shown in Figure 11. One or more releasable couplers 114 may extend distally and engage with the implant 10. One or more releasable couplers 114 may include a hook 156 in the distal portion of an elongated arm configured to engage with the frame of the implant 10. The hook 156 may project radially outward, as shown in Figure 11, or in embodiments, another projection direction may be used. The hook 156 that engages with the frame of the implant 10 is shown, for example, in Figures 8 and 9. The portion of the implant 10 at the proximal end 12 (for example, as shown in Figure 1) may include an exposed (or uncovered) frame 16, allowing the hook 156 to pass through the opening 26 between the support posts 22 and engage with the frame 16. In embodiments, other configurations of the releasable coupler may be available as desired.

[0047] One or more releasable couplers 114 may include multiple releasable couplers 114 spaced circumferentially apart from each other, as shown in Figure 11, or other spacings may be used as desired. One or more releasable couplers 114 may be positioned in the receiving portion 139 of the holder body 112, and may be spaced circumferentially in the receiving portion 139. Two or more, or three or more releasable couplers, or any other number may be used as desired. Three releasable couplers 114 are shown in Figure 11, but a different number may be used in embodiments.

[0048] One or more releaseable couplers 114 may be angled radially outward, for example, as shown in the cross-sectional view of Figure 15. Referring to Figure 15, one or more releaseable couplers 114 may be angled radially outward with respect to the central axis 158 of the holder. Thus, as the releaseable couplers 114 extend distally, the outward radial range of the releaseable couplers 114 increases. The releaseable couplers 114 may be configured to deflect radially inward so that the hook 156 can be deflected radially inward and released from the frame of the implant 10. The releaseable couplers 114 may be configured to deflect via the operation of an actuator 116.

[0049] Referring to Figure 13, the actuator 116 is shown separately from the holder body 112. In embodiments, the actuator 116 may be coupled to the holder body 112 and configured to operate to release one or more releaseable couplers 114 from the implant 10. As shown in Figure 13, the actuator 116 may include a central portion 160 and radially extending portions 162 that extend radially outward from the central portion 160. Three radially extending portions 162 are shown in Figure 13, but in embodiments, a larger or smaller number may be used as desired. The number of radially extending portions 162 may correspond to the number of releaseable couplers 114 in embodiments.

[0050] The central portion 160 may include a central support in the form of a button, as shown in Figure 13. The button may be configured to pass through the central opening 130 shown in Figure 12 and may be accessible on the proximal side of the holder body 112, as shown in Figure 8. In embodiments, other configurations of the central portion 160 may be used as desired.

[0051] The radially extending portion 162 may include arms as shown in Figure 13, and may be spaced circumferentially from one another. The spacing of the arms may, in embodiments, correspond to the positions of the detachable couplers 114. Each arm may include an opening 164 through which the respective detachable coupler 114 can pass. For example, the elongated arms of each detachable coupler 114 may pass through the opening 164 or may be configured to slide within the opening 164.

[0052] Each radially extending portion 162 may include a deflection surface 166, which may be configured to press against a coupler 114 that can be released as the actuator 116 moves. In embodiments, the actuator 116 may include one or more deflection surfaces 166.

[0053] Figure 14 shows a bottom perspective view of the actuator 116.

[0054] Referring to Figures 11 and 15, the actuator 116 may be positioned within the central cavity 142 of the holder body 112 such that the releasable couplers 114 pass through the opening 164 shown in Figure 14. The actuator 116 may be configured to move one or more releasable couplers 114 to release them from the implant 10. For example, the actuator 116 may be configured to slide distally within the central cavity 142 to release one or more releasable couplers 114 from the implant 10. The actuator 116 may slide to deflect one or more releasable couplers 114 away from the implant 10 to release one or more releasable couplers 114 from the implant 10.

[0055] Referring to Figure 15, with the implant 10 engaged with the releasable coupler 114, the actuator 116 may be in a proximal position with the button raised above the proximal surface 124. The radially extending portion 162 of the actuator 116 may also be in a raised proximal position. The releasable coupler 114 is deflected radially outward to engage with the frame of the implant 10.

[0056] Referring to Figure 16, when the actuator 116 is operated by being pushed distally relative to the holder body 112, the flexible surface 166 slides against the releaseable coupler 114, deflecting the releaseable coupler 114 away from the implant 10 and releasing the releaseable coupler 114 from the implant 10. The button on the actuator 116 can be pressed distally relative to the holder body 112, for example, to slide the flexible surface 166 against the releaseable coupler 114, deflecting the releaseable coupler 114 away from the implant 10 and releasing the releaseable coupler 114 from the implant 10. The flexible surface 166 can be pressed against the distal portion of the releaseable coupler 114, causing the distal portion to move radially inward and the hook 156 to move radially inward. The hook 156 can move radially inward to disengage from the frame of the implant 10, allowing the implant 10 to move distally away from the holder 110.

[0057] Next, the implant 10 released from the holder 110 may be used for implantation into the patient's body, or it may be used in preparation processes such as crimping the implant 10 to a delivery device.

[0058] When the holder 110 is connected to the implant 10, the holder 110 may be positioned at the end 12 of the implant 10, and the central axis 158 of the holder 110 is aligned with the central axis of the implant 10. The implant 10 may extend axially from the holder 110 and distally to the holder 110. As shown in Figures 8, 9, and 15, for example, the holder 110 may be positioned to cap the end 12 of the implant 10, and the implant 10 may extend longitudinally distally from the holder 110. The holder 110 may cover the end 12 of the implant 10, and the holder 110 (particularly the grip portion 120) may extend radially outward from the implant 10.

[0059] The holder 110 may hold the end 12 of the implant 10, allowing the remaining portion of the implant 10 extending longitudinally away from the holder 110 to be exposed by the holder 110. This feature can enhance the ability of the implant 10 to be sterilized while it is coupled to the holder 110, as the holder 110 may be positioned so that a sterilized gas or other sterilizing substance comes into contact with the implant 10. For example, the holder 110 may be positioned at the end 12 of the implant 10, allowing the implant 10 to be suspended in a container that can be used for sterilizing the implant. The holder 110 is positioned at the end 12 of the implant 10, allowing the portion of the implant 10 extending longitudinally away from the holder 110 to be exposed by the holder 110, allowing a sterilized gas or other sterilizing substance to come into contact with these exposed portions of the implant 10.

[0060] For example, Figure 17 shows a proximal portion 132 of holder 110 that can be coupled to a retainer 170 which may be used to support holder 110. The retainer 170 may include a ring 172 and a lid 174 coupled to the ring 172. The ring 172 may be configured to extend around the proximal portion 132 of holder 110, or it may have a shape that conforms to the shape of the proximal portion 132 of holder 110, including the shape of the grip portion 120. The lid 174 may be pivotably coupled to the ring 172 and may be configured to form a friction fit with the ring 172 when closed on holder 110. The retainer 170 may have the cover removed from the distal portion of holder 110, or the cover removed from implant 10, allowing a sterilization gas or another sterilization material to come into contact with these uncovered portions of implant 10.

[0061] The retainer 170 may be used to support the holder 110 for insertion and removal from the container 180, for example, as shown in Figure 18. Figure 18 shows that the holder 110, implant 10, and retainer 170 may be fitted into a container 180 which may be used for transporting, storing, and sterilizing the implant 10. For clarity, the lid 174 is excluded from the drawing in Figure 18, but may be used to cover and close the ring 172 and holder 110 as desired.

[0062] The container 180 may be configured to hold an implant 10 coupled to the holder body 112 and a releasable coupler 114 of the holder 110. The container 180 shown in Figure 18 may include a cavity 182 and one or more walls 184 having an inner surface 186 defining the cavity 182. The holder body 112 is configured to be coupled to the container 180 such that the holder body 112 suspends the implant 10 within the cavity 182. For example, the proximal portion 132 of the holder body 112 may be coupled to a retainer 170, which may be fitted into a recess 188 of the container 180 molded to receive the retainer 170. In embodiments, the retainer 170 may be omitted, and the holder body 112 may be configured to directly contact the recess 188 of the container 180. In embodiments, as shown in Figure 19, a lid 190 may be coupled to the top surface 192 of the container 180 and may cover the upper opening 194 of the container 180.

[0063] Figure 20 shows a cross-sectional view of a holder 110 that is coupled to the implant 10 and positioned within the container 180 along line BB in Figure 19. The holder 110 and implant 10 may be configured as shown in Figure 18. The holder 110 may suspend the implant 10 within the container 180 so that the implant 10 does not come into contact with the inner surface 186 of the container 180. This feature can advantageously allow the implant 10 to be sterilized within the container 180 without the implant 10 coming into contact with any part of the container 180, which can prevent sterilization gases or other substances from coming into contact with the implant 10. The features of the implant 10 shown in Figures 1-3, such as the artificial valve leaflets 18a-c and skirt 20, which can be considered “soft” components of the implant 10, are not in contact with any surface, including the surface of the holder 110. Therefore, the “soft” components may be kept completely out of contact with the holder 110 and container 180 during sterilization in order to improve the sterilization of these components.

[0064] In this embodiment, the lid 190 may be a gas-permeable lid that allows a sterilization gas such as ethylene oxide, or another sterilization gas, to penetrate through the lid 190 into the cavity 182 of the container 180. The gas-permeable lid 190 may cover the cavity 182 or seal the cavity 182. In this way, the implant 10 can be sterilized in the container 180 with the lid 190 sealing the cavity 182. In this embodiment, other forms of sterilization may be used.

[0065] During operation, once the implant 10 is fabricated, the implant 10 may be coupled to the holder 110. The implant 10 may be coupled to one or more releasable couplers 114 of the holder 110, which includes a holder body 112 coupled to one or more releasable couplers 114 and an actuator 116 coupled to the holder body 112, and is configured to operate to release one or more releasable couplers 114 from the implant 10. The end 12 of the implant 10, and preferably the proximal end 12 as shown in Figure 1, is positioned within the receiving portion of the holder 110 and may engage with the releasable couplers 114. The end 12 of the implant 10 may be in contact with the contact surface 154 of the holder body 112. The releasable couplers 114 may engage with the frame of the implant 10. The implant 10 may be positioned, for example, as shown in Figure 9.

[0066] Next, the holder 110 coupled to the implant 10 may be coupled to the retainer 170 as shown in Figure 17. The lid 174 of the retainer 170 may cover and close the ring 172. Then, the holder 110, implant 10, and retainer 170 may be inserted into the container 180 in the positions shown in Figure 18. The implant 10 coupled to the releasable coupler 114 may be positioned inside the container 180. The lid 190 shown in Figure 19 may be placed on the top surface 192 of the container 180 (marked in Figure 18) to cover and seal the cavity 182 of the container 180. The lid 190 may be applied over the cavity 182 of the container 180 using the implant 10 coupled to the releasable coupler 114 inside the container 180. The lid 190 may be a gas-permeable lid that covers the cavity 182.

[0067] The implant 10 may be suspended within the cavity 182 of the container 180 such that the artificial valve leaflets 18a-c of the implant 10 do not come into contact with the wall of the container 180. The implant 10 may be suspended within the cavity 182 of the container 180 such that the skirt 20 of the implant 10 does not come into contact with the wall of the container 180.

[0068] The implant 10 may be sterilized while the holder 110, retainer 170, and implant 10 are placed inside the sealed container 180. For example, a sterilized gas may be passed through the cavity 182 of the container 180 to sterilize the implant 10 contained within it. The sterilized gas may also pass through a gas-permeable lid 190. The implant 10 may be sterilized inside the container 180 with the lid 190 applied over the cavity 182 of the container 180. In one embodiment, the implant 10 may be transported to be sterilized while the holder 110, retainer 170, and implant 10 are placed inside the sealed container 180. For example, the holder 110, retainer 170, and implant 10 positioned inside the sealed container 180 may be transported to a sterilization facility, and the holder 110 may be used to support and secure the implant 10 during such transport.

[0069] After sterilization, container 180 may be placed in another container, such as a sealed bag. The implant 10 may be stored for a period of time and held by holder 110 during such storage.

[0070] After sterilization, and possibly during the device preparation procedure, the holder 110, retainer 170, and implant 10 may be moved to a device preparation area, such as a clinician's preparation area (or a preparation area that may be used by a surgeon). The holder 110 may be used to support and secure the implant 10 during such transport.

[0071] The lid 190 may be removed from the container 180. Next, the retainer 170 may be grasped together with the holder 110 and the implant 10 coupled to it and removed from the container 180. The retainer 170 may then be removed from the holder 110 and the implant 10. The implant 10, coupled to the releaseable coupler 114, may be removed from the container 180 in which the implant 10 has been sterilized.

[0072] The implant 10 coupled to the holder 110 may be positioned in close proximity to a container, such as a vessel that may contain a fluid for moistening the implant 10. The implant 10 and holder 110 may be positioned on top of such a container. The user may grasp the grip portion 120, as shown in Figure 15. The user may then operate the actuator 116 of the holder 110 to release the implant 10 from the releaseable coupler 114 of the holder 110, as shown in Figure 16. The actuator 116 may be moved to release the releaseable coupler 114 from the implant 10. The actuator 116 may be slid to deflect the releaseable coupler 114 away from the implant 10, thereby releasing the releaseable coupler 114 from the implant 10. The button of the actuator 116 is pressed distally against the holder body 112, causing the flexible surface 166 to slide against the releaseable coupler 114, thereby deflecting the releaseable coupler 114 away from the implant 10 and releasing the releaseable coupler 114 from the implant 10. In embodiments, the implant 10 may be dropped into a container that may contain a fluid for moistening the implant 10.

[0073] The implant 10, released from the holder 110, can then be used for implantation. For example, a crimping procedure utilizing the crimping device 84 shown in Figures 6 and 7 may be used. The implant 10 may be crimped to the delivery device 44, particularly the implant holding area 54 of the delivery device, as shown in Figures 4 and 5. The delivery device 44 and the implant 10 may be positioned within the channel 90 of the crimping device 84 and crimped within the channel. The implant 10 may be delivered to the implantation site for implantation using the delivery device 44. In other embodiments, other forms of device preparation and implantation may be used.

[0074] As disclosed herein, the holder may be modified in embodiments. For example, the configuration of the grip portion may be modified in embodiments and may have various shapes and other configurations other than those shown in Figures 8-12. In embodiments, the configuration of the releasable coupler may be modified from the configurations shown in Figures 8-12. For example, various forms of latches, grippers, clamps, or other forms of couplers may be used in embodiments. The method of coupling to the implant may be modified in embodiments. The configuration of the actuator may be modified in embodiments. The actuator may cause the releasable coupler to be released from the implant in various ways. The actuator may be configured, for example, in embodiments to cause the releasable coupler to be released from the implant by pulling, twisting, mechanical or electrical activation, or deformation (including snapping or breaking). Various other configurations of the holder and the holder body may be provided as desired.

[0075] Furthermore, the method steps disclosed herein may be modified as desired.

[0076] As disclosed herein, the holder can advantageously improve the retention of the implant 10 and improve the release of the implant 10 from the holder. For example, the user can release the implant 10 from the holder by relatively easily operating the actuator 116. The holder may suspend the implant 10 in place for sterilization and transport.

[0077] In embodiments, the holder may include a holder clip disclosed herein, which can engage with a portion of the implant 10 to hold the implant 10. The holder disclosed herein may be handheld and portable and configured to be transported for transporting the implant 10 coupled thereto. The holder may be configured to be operated and controlled via handheld operation or via a device such as a clamp or another gripping device. The holder disclosed herein may be used for transporting or storing the implant 10 as desired. Such transport or storage may occur before implantation of the implant 10 in the patient's body, or before a crimping step or device preparation step that may occur before implantation.

[0078] The holders disclosed herein may, for the benefit of their nature, enable single-step operation, in which the actuator may be operated in a single step. For example, as shown in Figures 15 and 16, a single-step operation of the actuator may occur, in which case the actuator is pushed in a direction that releases the implant 10. Such single-step release may improve the ease of use of the holder. Other forms of single-step operation may include a single pull, twist, mechanical or electrical initiation, or deformation, among other single-step operations.

[0079] The holder may be positioned at the end of the implant 10 such that the longitudinal axes of the implant and the holder are aligned, and the implant 10 extends longitudinally away from the holder. In this way, the outer surface of the implant 10 and the “soft” components disclosed herein can be exposed for sterilization and sterilization of these components can be improved. The holder may be positioned at the end of the implant 10 facing the position of the skirt 20, as shown in Figure 1, and in the direction in which the valve leaflets 18a to c open during operation.

[0080] In embodiments, the implant 10 may include a medical implant such as an implantable artificial valve or another form of implant. In embodiments, the implantable artificial valve may include an implantable artificial heart valve such as an artificial aortic valve, pulmonary valve, mitral valve, or tricuspid valve. Various other forms of implantable artificial valves may be used, and various other forms of implants may be used in embodiments.

[0081] As will be discussed, various forms of implants, including, in particular, artificial heart valves, or other forms of implants such as stents or filters, or diagnostic devices, may be used with the embodiments disclosed herein. The implant may be an expandable implant configured to move from a compressed or un-deployed state to an expanded or un-deployed state. The implant may be a compressible implant having a reduced outer contour and configured to compress inward to move the implant to a compressed or un-deployed state. The crimping devices disclosed herein may assist in moving the implant to a compressed or un-deployed state.

[0082] Delivery devices such as those disclosed herein may also be used for the replacement and repair of aortic, mitral, tricuspid, and pulmonary valves. Delivery devices may, in particular, include those for the delivery of stents or filters, or other forms of implants such as diagnostic devices.

[0083] The delivery devices and systems disclosed herein may be used for transcatheter aortic valve implantation (TAVI) or replacement of other autologous heart valves (e.g., mitral valve, tricuspid valve, or pulmonary valve). The delivery devices and systems disclosed herein may be used for transarterial access to the patient's heart, including transfemoral access. The delivery devices and systems may be used for transcatheter percutaneous procedures, including transarterial procedures which may be transfemoral or transjugular. Transradicular procedures may also be used, in particular. Other procedures may be used as desired.

[0084] Features of the embodiments may be modified, replaced, excluded, or combined throughout the embodiments as desired.

[0085] Furthermore, the methods described herein are not limited to those specifically described herein, but may include methods utilizing the systems and apparatus disclosed herein. Steps of the methods may be modified, excluded, or added using the systems, apparatus, and methods disclosed herein.

[0086] Features of the embodiments disclosed herein may be implemented independently of the crimping device or independently of other components disclosed herein. Various devices of the system may be implemented independently.

[0087] In summary, while aspects of this specification are emphasized by reference to specific embodiments, it will be understood that those skilled in the art will readily recognize that these disclosed embodiments are merely illustrative of the principles of the subject matter disclosed herein. Therefore, it should be understood that the disclosed subject matter is by no means limited to the specific methodologies, protocols, and / or reagents described herein. Accordingly, various modifications or alterations, or alternative configurations, of the subject matter of this disclosure can be made in accordance with the teachings herein without departing from the spirit of this specification. Finally, the terms used herein are intended to describe only specific embodiments and are not intended to limit the scope of systems, apparatus, and methods disclosed herein, which are defined solely by the claims. Therefore, the systems, apparatus, and methods are not precisely limited to those illustrated and described herein.

[0088] Specific embodiments of systems, apparatuses, and methods are described herein, including the best modes known to the inventors for performing them. Naturally, variations of these described embodiments will be apparent to those skilled in the art upon reading the above description. The inventors expect those skilled in the art to adopt such variations as appropriate, and the inventors intend systems, apparatuses, and methods to be performed in ways other than those specifically described herein. Accordingly, systems, apparatuses, and methods include all modifications and equivalents of the subject matter enumerated in the claims appended herein, as permitted by applicable law. Furthermore, unless otherwise suggested herein or unless clearly contradicted by context, any combination of the above embodiments in all possible variations thereof is encompassed by systems, apparatuses, and methods.

[0089] The grouping of alternative embodiments, elements, or steps of a system, apparatus, or method should not be construed as limitation. Each group member may be referred to and claimed individually or in any combination with other group members disclosed herein. It is anticipated that one or more members of a group may be included in or removed from a group for convenience and / or patentability reasons. In the event of such inclusion or omission, this specification shall be deemed to contain the modified groups and thus satisfy the description of all Markush groups used in the appended claims.

[0090] Unless otherwise indicated, all figures used herein to represent features, items, quantities, parameters, characteristics, terms, etc., should be understood in all cases to be modified by the term “about.” Where used herein, the term “about” means that the feature, item, quantity, parameter, characteristic, or term thus modified encompasses a variable approximation, but can still perform the desired operation or process discussed herein.

[0091] The terms “a,” “an,” “the,” and similar reference terms used in the context of describing systems, apparatuses, and methods (particularly in the context of the following claims) shall be interpreted as encompassing both singular and plural forms unless otherwise suggested herein or unless the context clearly contradicts them. All methods described herein may be performed in any appropriate order unless otherwise suggested herein or unless the context clearly contradicts them. Any and all examples or exemplary language provided herein (e.g., “such as”) is intended merely to better illuminate the systems, apparatuses, and methods and does not otherwise impose limitations on the scope of the claimed systems, apparatuses, and methods. Nothing in this specification should be interpreted as indicating any unclaimed elements essential to the practice of the systems, apparatuses, and methods.

[0092] All patents, patent publications, and other publications referenced and identified herein are incorporated herein individually and expressly by reference in whole for the purpose of describing and disclosing compositions and methodologies described in such publications, which may be used, for example, in connection with systems, apparatus, and methods. These publications were made available prior to the filing date of this application, solely for the purpose of their disclosure. Nothing in this regard should be construed as an acknowledgment that the inventor does not have prior rights to such disclosure on the grounds of prior invention or for any other reason. All statements regarding dates or representations relating to the contents of these documents are based on information available to the applicant and do not constitute an endorsement of the accuracy of the dates or contents of these documents.

Claims

1. A holder system for an implantable artificial valve, wherein the holder system is The holder body and One or more releasable connectors, which are coupled to the holder body and configured to hold the implantable artificial valve in the holder body, The holder body comprises an actuator coupled to the holder body and configured to operate to release one or more detachable couplers from the implantable artificial valve, A holder system in which a portion of the actuator passes through a central opening formed in the central part of the holder body.

2. The holder system according to claim 1, wherein the holder body includes one or more grip portions.

3. The holder system according to claim 2, wherein one or more grip portions are in the form of arms that form rings extending circumferentially around the central portion.

4. The holder system according to claim 2 or 3, wherein one or more of the grip portions are configured to be grasped by hand or by a clamp.

5. The holder system according to any one of claims 2 to 4, wherein one or more grip portions extend radially outward from the central portion of the holder body.

6. The holder system according to any one of claims 1 to 5, wherein the holder body includes a contact surface for contacting a portion of the implantable artificial valve.

7. The holder system according to claim 6, wherein the contact surface is configured to contact the end of the implantable artificial valve.

8. The holder system according to any one of claims 1 to 7, wherein the holder body includes a recess for receiving a portion of the implantable artificial valve.

9. The holder system according to any one of claims 1 to 8, wherein the actuator is configured to move to release one or more detachable couplers from the implantable artificial valve.

10. The holder system according to any one of claims 1 to 9, wherein the actuator is configured to slide to release one or more releasable couplers from the implantable artificial valve.

11. The holder system according to any one of claims 1 to 10, wherein the actuator is configured to deflect the one or more releaseable couplers away from the implantable artificial valve, and to slide the one or more releaseable couplers away from the implantable artificial valve.

12. The holder system according to any one of claims 1 to 11, wherein the holder body includes a central cavity for receiving the actuator.

13. The holder system according to claim 12, wherein the actuator is configured to slide within the central cavity to release one or more releasable couplers from the implantable artificial valve.

14. The holder system according to any one of claims 1 to 13, wherein the one or more detachable couplers comprises one or more hooks configured to engage with the frame of the implantable artificial valve.

15. The holder system according to any one of claims 1 to 14, wherein the holder body includes a proximal portion and a distal portion for contacting the implantable artificial valve, and one or more releasable couplers extend distally and engage with the implantable artificial valve.

16. The holder system according to claim 15, wherein the actuator includes a button and one or more flexible surfaces, the button is configured to press distally relative to the holder body such that the one or more flexible surfaces slide against the one or more releaseable couplers, thereby deflecting the one or more releaseable couplers away from the implantable artificial valve, and releasing the one or more releaseable couplers from the implantable artificial valve.

17. The holder system according to any one of claims 1 to 16, wherein the one or more releasable couplers include a plurality of releasable couplers spaced circumferentially apart from one another.

18. The holder system according to any one of claims 1 to 17, further comprising a container configured to hold the implantable artificial valve coupled to the holder body and the one or more releasable connectors.

19. The holder system according to claim 18, wherein the container includes a cavity and one or more inner surfaces defining the cavity, and the holder body is configured to be coupled to the container such that the holder body suspends the implantable artificial valve within the cavity.

20. The holder system according to claim 19, wherein the container includes a gas-permeable lid configured to cover the cavity.

21. The present invention includes coupling an implantable artificial valve to one or more releasable couplers of a holder, wherein the holder comprises a holder body coupled to the one or more releasable couplers, and an actuator coupled to the holder body and configured to operate to release the one or more releasable couplers from the implantable artificial valve, A method wherein a portion of the actuator passes through a central opening formed in the central part of the holder body.

22. The method according to claim 21, further comprising positioning the end of the implantable artificial valve within the receiving portion of the holder.

23. The method according to claim 22, further comprising bringing the end of the implantable artificial valve into contact with the contact surface of the holder body.

24. The method according to any one of claims 21 to 23, wherein the actuator is configured to move to release one or more detachable couplers from the implantable artificial valve.

25. The method according to any one of claims 21 to 24, further comprising positioning the implantable artificial valve, which is coupled to one or more detachable couplers, within a container.

26. The method according to claim 25, further comprising suspending the implantable artificial valve within the cavity of the container such that one or more of the artificial valve leaflets of the implantable artificial valve do not come into contact with the wall of the container.

27. The method according to claim 25 or 26, further comprising suspending the implantable artificial valve within the cavity of the container such that the skirt of the implantable artificial valve does not come into contact with the wall of the container.

28. The method according to any one of claims 25 to 27, further comprising covering the cavity of the container with a lid while the implantable artificial valve is coupled to one or more releasable couplers within the container.

29. The method according to claim 28, wherein the lid is a gas-permeable lid that covers the cavity.

30. The method according to claim 28 or 29, further comprising sterilizing the implantable artificial valve in the container with the lid applied to cover the cavity of the container.

31. The method according to any one of claims 21 to 30, wherein the holder body includes one or more grip portions.

32. The method according to claim 31, wherein the one or more grip portions include one or more arms.

33. The method according to claim 31 or claim 32, wherein one or more of the grip portions are configured to be grasped by hand or by a clamp.

34. The method according to any one of claims 31 to 33, wherein one or more grip portions extend radially outward from the central portion of the holder body.

35. The method according to any one of claims 21 to 34, wherein the holder body includes a contact surface for contacting a portion of the implantable artificial valve.

36. The method according to any one of claims 21 to 35, wherein the holder body includes a recess for receiving a portion of the implantable artificial valve.

37. The method according to any one of claims 21 to 36, wherein the holder body includes a central cavity for receiving the actuator.

38. The method according to any one of claims 21 to 37, wherein the one or more detachable couplers comprises one or more hooks configured to engage with the frame of the implantable artificial valve.

39. The method according to any one of claims 21 to 38, wherein the holder body includes a proximal portion and a distal portion for contacting the implantable artificial valve, and one or more releasable couplers extend distally to engage with the implantable artificial valve.

40. The method according to any one of claims 21 to 39, wherein the one or more detachable couplers include a plurality of detachable couplers spaced apart from each other in the circumferential direction.

41. The process includes operating the actuator of a holder to release an implantable artificial valve from one or more releasable couplers of the holder, wherein the holder comprises a holder body coupled to the one or more releasable couplers, and the actuator, A method wherein a portion of the actuator passes through a central opening formed in the central part of the holder body.

42. The method according to claim 41, further comprising moving the actuator to release the implantable artificial valve from the one or more releasable couplers of the holder.

43. The method according to claim 41 or 42, further comprising sliding the actuator to release the implantable artificial valve from one or more releasable couplers of the holder.

44. The method according to claim 43, further comprising sliding the actuator to deflect the one or more detachable couplers away from the implantable artificial valve, thereby releasing the one or more detachable couplers from the implantable artificial valve.

45. A method according to any one of claims 41 to 44, wherein the holder body includes a proximal portion and a distal portion for contacting the implantable artificial valve, and the actuator includes a button and one or more flexible surfaces, the method further comprising pressing the button distally to the holder body to slide the one or more flexible surfaces against the one or more releaseable couplers to deflect the one or more releaseable couplers away from the implantable artificial valve.

46. The method according to any one of claims 41 to 45, further comprising grasping one or more grip portions of the holder body.

47. The method according to claim 46, wherein the one or more grip portions comprises one or more arms.

48. The method according to claim 46 or claim 47, wherein one or more of the grip portions are configured to be grasped by hand or by a clamp.

49. The method according to any one of claims 46 to 48, wherein one or more grip portions extend radially outward from the central portion of the holder body.

50. The method according to any one of claims 41 to 49, wherein the end of the implantable artificial valve is positioned within the receiving portion of the holder, and the one or more releasable couplers engage with the frame of the implantable artificial valve.

51. The method according to any one of claims 41 to 50, further comprising removing the implantable artificial valve, which is coupled to one or more detachable couplers, from a container in which the implantable artificial valve has been sterilized.

52. The method according to claim 51, further comprising removing a gas-permeable lid from the container.

53. The method according to any one of claims 41 to 52, wherein the holder body includes a contact surface for contacting a portion of the implantable artificial valve.

54. The method according to claim 53, wherein the contact surface is configured to contact the end of the implantable artificial valve.

55. The method according to any one of claims 41 to 54, wherein the holder body includes a recess for receiving a portion of the implantable artificial valve.

56. The method according to any one of claims 41 to 55, wherein the holder body includes a central cavity for receiving the actuator.

57. The method according to claim 56, wherein the actuator is configured to slide within the central cavity to release one or more releasable couplers from the implantable artificial valve.

58. The method according to any one of claims 41 to 57, wherein the one or more detachable couplers include one or more hooks configured to engage with the frame of the implantable artificial valve.

59. The method according to any one of claims 41 to 58, wherein the holder body includes a proximal portion and a distal portion for contacting the implantable artificial valve, and one or more releasable couplers extend distally and engage with the implantable artificial valve.

60. The method according to any one of claims 41 to 59, wherein the one or more releasable couplers include a plurality of releasable couplers spaced apart from each other in the circumferential direction.

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