Iris type crimper for medical devices

Abstract

A crimper for changing an implantable medical device from an uncompressed state to a compressed state. The crimper includes a plurality of crimper elements defining a crimper slot, each crimper element including a non-planar surface forming a portion of the crimper slot. Each non-planar surface is configured to apply non-uniform radial compression along a length of the implantable medical device during operation of the crimper in changing the implantable medical device from the uncompressed state to the compressed state. The crimper further includes a handle configured to operate the crimper. Actuation of the handle causes a volume of the crimper chamber to decrease to transform the implantable medical device from the uncompressed state to the compressed state.

Description

[0001] Cross-references to related applications

[0002] This application claims priority to the following patent applications: U.S. Nonprovisional Patent Application Serial No. 17 / 394,025, filed August 4, 2021; U.S. Provisional Patent Application Serial No. 63 / 228,208, filed August 2, 2021; U.S. Provisional Patent Application Serial No. 63 / 080,978, filed September 21, 2020; and U.S. Provisional Patent Application Serial No. 63 / 061,874, filed August 6, 2020, each of which is incorporated herein by reference in its entirety for all purposes. Technical Field

[0003] This application generally relates to devices for compressing and folding stents, artificial heart valves and other implantable vascular medical devices. Background Technology

[0004] Currently, expandable implantable medical devices (such as artificial valves and other cardiac interventional devices) that include scaffold structures and organic tissue (e.g., bovine and swine organic tissue) need to be folded onto a delivery device in the field at implantation sites such as catheterization labs. This is because implantable devices need to be stored under specific conditions to preserve organic tissue. Typically, iris-type folders are used during the folding process. Current iris-type folders are limited by the difficulty in accurately positioning the medical device relative to the delivery device inside the lateral-loading folder due to the difficulty of lateral insertion. This difficulty can lead to time delays and damage to the device by operators without experience in folding medical devices, as the tissue contains the implantable device that needs to be folded immediately before implantation by medical personnel. Given the cost of such devices, the possibility of destroying or damaging them can be significant. Summary of the Invention

[0005] The technology disclosed herein generally relates to a compression device for mounting an implantable medical device onto a delivery device and for converting the implantable medical device from an expanded state to a compressed state.

[0006] According to a first embodiment herein, this disclosure provides a flip-type folding device for changing an expandable medical device from an uncompressed state to a compressed state. The folding device includes a top housing and a base housing. The top housing includes a plurality of first folding elements defining a top groove, and the base housing includes a plurality of second folding elements defining a bottom groove. The top housing and the base housing are connected at a pivot connection. The top housing is configured to rotate relative to the base housing about the pivot connection from an open state to a closed state. When in the open state, the second grooves are exposed for insertion of the expandable medical device, and when in the closed state, the top and bottom grooves define a folding chamber. The folding device also includes: a handle configured to operate the flip-type folding device; one or more cams coupled to the handle; and one or more levers coupled to the one or more cams, the plurality of first folding elements, and the plurality of second folding elements. When in the closed state, movement of the handle rotates the one or more cams, thereby displacing the plurality of first folding elements and the plurality of second folding elements via the levers. The displacement of multiple first and multiple second compression elements reduces the volume of the compression chamber, thereby allowing the expandable medical device to transition from an uncompressed state to a compressed state.

[0007] In one aspect of the first embodiment and in conjunction with any other aspect herein, this disclosure provides that the top housing or base housing includes a first housing and a second housing. A plurality of first compression elements are each movably coupled within the first housing and the second housing.

[0008] In one aspect of the first embodiment and in conjunction with any other aspect herein, this disclosure provides that one of the first housing or the second housing includes a side panel having an inner surface and an outer surface. One or more crease grooves are formed within the inner surface of the side panel, and the one or more crease grooves are configured to allow displacement of a plurality of first crease elements or a plurality of second crease elements.

[0009] In one aspect of the first embodiment and in conjunction with any other aspect herein, this disclosure provides that a folding element among a plurality of first folding elements or a plurality of second folding elements includes: a folding convex angle, wherein a portion of the folding convex angle forms part of a folding chamber; and a first leg and a second leg connected to the folding convex angle. One of one or more bars is connected to the folding element between the first leg and the second leg.

[0010] In one aspect of the first embodiment and in conjunction with any other aspect herein, this disclosure provides that the folding convex corner includes a folding space defined by one or more ramps, and at least one of the one or more ramps contacts an adjacent folding convex corner of an adjacent folding element among a plurality of first folding elements or a plurality of second folding elements.

[0011] In one aspect of the first embodiment and in conjunction with any other aspect herein, this disclosure provides that the handle includes a handle rod and a connecting member that is coupled to the handle rod and configured to engage with at least one of one or more cams.

[0012] In one aspect of the first embodiment and in conjunction with any other aspect herein, this disclosure provides that the base housing includes one or more base surfaces for supporting the flap-type folding device.

[0013] In one aspect of the first embodiment and in conjunction with any other aspect herein, this disclosure provides that the top housing further includes a first locking mechanism. The first locking mechanism prevents movement of the handle that would allow the top housing to change from a closed state to an open state.

[0014] In one aspect of the first embodiment and in conjunction with any other aspect herein, this disclosure provides that at least one of the top housing or the base housing further includes a second locking mechanism that locks the top housing and the base housing in a closed state.

[0015] In one aspect of the first embodiment and in conjunction with any other aspect herein, this disclosure provides that the folding device further includes one or more stops that restrict the movement of the handle.

[0016] According to a second embodiment of this document, this disclosure provides a folding device for changing an expandable medical device from an uncompressed state to a compressed state. The folding device includes: a folding device housing comprising a plurality of folding elements defining folding grooves; a handle configured to operate the folding device; one or more cams coupled to the handle; and one or more levers coupled to the one or more cams and the plurality of folding elements. Movement of the handle rotates the one or more cams, thereby displacing a plurality of first folding elements and a plurality of second folding elements via the levers. The displacement of the plurality of folding elements reduces the volume of the folding chamber, thereby changing the expandable medical device from an uncompressed state to a compressed state.

[0017] In one aspect of the second embodiment and in conjunction with any other aspect herein, this disclosure provides that the folding housing includes a first side and a second side, and a plurality of folding elements are each movably coupled within the first side and the second side.

[0018] In one aspect of the second embodiment and in conjunction with any other aspect herein, this disclosure provides that one of the first or second sides includes one or more crease grooves formed within the inner surface of the first or second side. The one or more crease grooves are configured to allow displacement of a plurality of crease elements.

[0019] In one aspect of the second embodiment and in conjunction with any other aspect herein, this disclosure provides that a folding element among a plurality of first folding elements or a plurality of second folding elements includes: a folding convex angle, a portion of which forms part of a folding chamber; and a first leg and a second leg connected to the folding convex angle. One of one or more bars is connected to the folding element between the first leg and the second leg.

[0020] In one aspect of the second embodiment and in conjunction with any other aspect herein, this disclosure provides that the folding convex corner includes a folding space defined by one or more ramps. At least one of the one or more ramps contacts an adjacent folding convex corner of an adjacent folding element among a plurality of first folding elements or a plurality of second folding elements.

[0021] In one aspect of the second embodiment and in conjunction with any other aspect herein, this disclosure provides that the handle includes a handle rod and a connecting member that is coupled to the handle rod and configured to engage with at least one of one or more cams.

[0022] In one aspect of the second embodiment and in conjunction with any other aspect herein, this disclosure provides that the handle includes a handle lever and a handle cam configured to engage with one or more cams and transmit motion of the handle lever to one or more cams.

[0023] In one aspect of the second embodiment and in conjunction with any other aspect herein, this disclosure provides that one or more cams include a first cam coupled to a first portion of the handle and a second cam coupled to the first portion of the handle. One end of one or more levers is coupled between the first cam and the second cam.

[0024] In one aspect of the second embodiment and in conjunction with any other aspect herein, this disclosure provides that one or more levers each include a lever portion and a first leg and a second leg connected to the lever portion. One or more cams are connected between the first leg and the second leg to each of the one or more levers.

[0025] In one aspect of the second embodiment and in conjunction with any other aspect herein, this disclosure provides that the crease further includes a base that is coupled to the crease housing to support the crease.

[0026] In one aspect of the second embodiment and in conjunction with any other aspect herein, this disclosure provides that the folding device further includes one or more stops that restrict the movement of the handle.

[0027] According to a third embodiment of this document, this disclosure provides a method for changing an expandable medical device from an uncompressed state to a compressed state. A flip-top folding device is placed in an open state, the flip-top folding device including a top iris housing and a base iris housing connected by a pivot connection. When in the open state, a base iris groove of the base iris housing is exposed for insertion of the expandable medical device. The expandable medical device is inserted into the iris groove of the base iris housing. The folding device is changed from the open state to a closed state. When in the closed state, the top iris groove of the top iris housing and the base iris groove of the base iris housing define a folding chamber. The handle of the flip-top folding device is actuated to reduce the volume of the folding chamber, thereby changing the expandable medical device from an uncompressed state to a compressed state.

[0028] According to a fourth embodiment herein, this disclosure provides a flip-type folding device for changing an implantable medical device from an uncompressed state to a compressed state. The folding device includes a top housing comprising a top cam, a top folding element housing, and a plurality of first folding elements defining a top groove. The folding device also includes a base housing comprising a base cam, a base folding element housing, and a plurality of second folding elements defining a bottom groove. The top housing and the base housing are connected at a pivot connection. The top housing is configured to rotate relative to the base housing about the pivot connection from an open state to a closed state. When in the open state, the second grooves are exposed for insertion of an expandable medical device. When in the closed state, the top and bottom grooves define a folding chamber. The folding device includes a handle configured to operate the flip-type folding device and is at least connected to the top cam of the top housing. When in the closed state, the movement of the handle causes the top cam and the base cam to rotate, thereby displacing multiple first folding elements and multiple second folding elements. The displacing of multiple first folding elements and multiple second folding elements reduces the volume of the folding chamber so that the implantable medical device changes from an uncompressed state to a compressed state.

[0029] In one aspect of the fourth embodiment and in conjunction with any other aspect herein, this disclosure provides that a plurality of first folding elements are movably coupled within a top folding element housing and a base folding element housing.

[0030] In one aspect of the fourth embodiment and in conjunction with any other aspect herein, this disclosure provides that one of the top folding element housing or the base folding element housing includes a side plate including an inner surface and an outer surface. One or more folding grooves are formed within the inner surface of the side plate, and the one or more folding grooves are configured to allow displacement of a plurality of first folding elements or a plurality of second folding elements.

[0031] In one aspect of the fourth embodiment and in conjunction with any other aspect herein, this disclosure provides that a folding element among a plurality of first folding elements or a plurality of second folding elements includes: a folding convex angle, wherein the surface of the folding convex angle forms part of a folding chamber; a folding body connected to the folding convex angle; and at least one pin connected to the folding body. The at least one pin is configured to movably connect the folding element to one of a top cam and a base cam.

[0032] In one aspect of the fourth embodiment and in conjunction with any other aspect herein, this disclosure provides that the at least one pin comprises two pins positioned on opposite sides of the folder body.

[0033] In one aspect of the fourth embodiment and in conjunction with any other aspect herein, this disclosure provides that the folding convex corner includes a folding space defined by one or more ramps. At least one of the one or more ramps contacts an adjacent folding convex corner of an adjacent folding element among a plurality of first folding elements or a plurality of second folding elements.

[0034] In one aspect of the fourth embodiment and in conjunction with any other aspect herein, this disclosure provides that at least one of the top cam and the base cam includes at least one pin groove formed within the surface of the top cam or the base cam. The pin groove is configured to receive at least one pin of the pressing element.

[0035] In one aspect of the fourth embodiment and in conjunction with any other aspect herein, this disclosure provides that at least one pin groove includes a plurality of pin grooves formed in a spiral pattern.

[0036] In one aspect of the fourth embodiment and in conjunction with any other aspect herein, this disclosure provides that the handle includes a handle rod portion and a handle base portion, the handle base portion being coupled to the handle rod portion and configured to be coupled to at least one of a top cam and a base cam.

[0037] In one aspect of the fourth embodiment and in conjunction with any other aspect herein, this disclosure provides that the base housing includes one or more base surfaces for supporting the flap-type folding device.

[0038] In one aspect of the fourth embodiment and in conjunction with any other aspect herein, this disclosure provides that the top housing further includes a first locking mechanism. The first locking mechanism prevents movement of the handle that would allow the top housing to change from a closed state to an open state.

[0039] In one aspect of the fourth embodiment and in conjunction with any other aspect herein, this disclosure provides that at least one of the top housing or the base housing further includes a second locking mechanism. The second locking mechanism locks the top housing and the base housing in a closed state.

[0040] In one aspect of the fourth embodiment and in conjunction with any other aspect herein, this disclosure provides that the folding device further includes one or more stops that restrict the movement of the handle.

[0041] According to a fifth embodiment herein, this disclosure provides a flip-type folding device for changing an implantable medical device from an uncompressed state to a compressed state. The folding device includes a top iris housing comprising a plurality of first folding elements defining a top iris groove. The folding device also includes a base iris housing coupled at a pivot connection to the top iris housing, the base iris housing comprising a plurality of second folding elements defining a base iris groove. The top iris housing is configured to rotate relative to the base housing about the pivot connection from an open state to a closed state. When in the open state, the base iris groove is exposed for insertion of an expandable medical device. When in the closed state, the top iris groove and the base iris groove define a folding chamber. The folding device also includes a handle configured to operate the flip-type folding device. Actuation of the handle reduces the volume of the folding chamber to change the implantable medical device from an uncompressed state to a compressed state.

[0042] In one aspect of the fifth embodiment and in conjunction with any other aspect herein, this disclosure provides that a plurality of first folding elements are movably coupled within a top iris housing, and a plurality of second folding elements are movably coupled within a base iris housing.

[0043] In one aspect of the fifth embodiment and in conjunction with any other aspect herein, this disclosure provides that a folding element among a plurality of first folding elements or a plurality of second folding elements includes: a folding convex angle, wherein the surface of the folding convex angle forms part of a folding chamber; a folding body coupled to the folding convex angle; and at least one pin coupled to the folding body. The at least one pin is configured to movably engage the folding element with one of at least one cam of the top iris housing and at least one cam of the base iris housing.

[0044] In one aspect of the fifth embodiment and in conjunction with any other aspect herein, this disclosure provides that the at least one pin comprises two pins positioned on opposite sides of the folder body.

[0045] In one aspect of the fifth embodiment and in conjunction with any other aspect herein, this disclosure provides that the folding convex corner includes a folding space defined by one or more ramps. At least one of the one or more ramps contacts an adjacent folding convex corner of an adjacent folding element among a plurality of first folding elements or a plurality of second folding elements.

[0046] In one aspect of the fifth embodiment and in conjunction with any other aspect herein, this disclosure provides that at least one cam includes at least one pin groove formed within the surface of at least one cam. The at least one pin groove is configured to receive at least one pin of a pressing element.

[0047] In one aspect of the fifth embodiment and in conjunction with any other aspect herein, this disclosure provides that at least one pin groove includes a plurality of pin grooves formed in a spiral pattern.

[0048] In one aspect of the fifth embodiment and in conjunction with any other aspect herein, this disclosure provides that the base iris housing includes one or more base surfaces for supporting the flip-type folding device.

[0049] In one aspect of the fifth embodiment and in conjunction with any other aspect herein, this disclosure provides that the top iris housing further includes a first locking mechanism that prevents movement of the handle from enabling the top iris housing to change from a closed state to an open state.

[0050] In one aspect of the fifth embodiment and in conjunction with any other aspect herein, this disclosure provides that at least one of the top iris housing or the base iris housing further includes a second locking mechanism that locks the top iris housing and the base iris housing into a closed state.

[0051] In one aspect of the fifth embodiment and in conjunction with any other aspect herein, this disclosure provides that the folding device further includes one or more stops that restrict the movement of the handle.

[0052] According to a sixth embodiment of this document, this disclosure provides a method for changing an expandable medical device from an uncompressed state to a compressed state. The method includes placing a flip-type folding device in an open state, the flip-type folding device including a top iris housing and a base iris housing connected by a pivot connection. When in the open state, a base iris groove of the base iris housing is exposed for insertion of the expandable medical device. The method further includes inserting the expandable medical device into the iris groove of the base iris housing. Further, the method includes changing the folding device from the open state to a closed state. When in the closed state, the top iris groove of the top iris housing and the base iris groove of the base iris housing define a folding chamber. The method includes actuating a handle of the flip-type folding device, wherein actuation of the handle reduces the volume of the folding chamber to change the expandable medical device from an uncompressed state to a compressed state.

[0053] According to a seventh embodiment herein, this disclosure provides a folding device for changing an implantable medical device from an uncompressed state to a compressed state. The folding device includes a plurality of folding elements defining folding grooves, each folding element including a non-planar surface forming a portion of the folding groove. Each non-planar surface is configured to apply non-uniform radial compression along the length of the implantable medical device during operation of the folding device when changing the implantable medical device from an uncompressed state to a compressed state. The folding device also includes a handle configured to operate the folding device. Actuation of the handle reduces the volume of the folding chamber, thereby changing the implantable medical device from an uncompressed state to a compressed state.

[0054] In one aspect of the seventh embodiment and in conjunction with any other aspect herein, this disclosure provides that each folding element includes: a folding convex angle, wherein the folding convex angle includes a non-planar surface; a folding body connected to the folding convex angle; and at least one pin connected to the folding body.

[0055] In one aspect of the seventh embodiment and in conjunction with any other aspect herein, this disclosure provides that the folding convex corner includes a folding space defined by one or more ramps. At least one of the one or more ramps contacts an adjacent folding convex corner of an adjacent folding element among a plurality of folding elements.

[0056] In one aspect of the seventh embodiment and in conjunction with any other aspect herein, this disclosure provides that the non-planar surface includes a first longitudinal portion and a second longitudinal portion, the second longitudinal portion being configured to be closer to the centerline of the compression chamber than the first longitudinal portion, such that the second longitudinal portion is configured to apply a higher radial force to the implantable medical device compared to the first longitudinal portion.

[0057] In one aspect of the seventh embodiment and in conjunction with any other aspect thereof, this disclosure provides that the first longitudinal portion extends between 35% and 45% of the total length of the folding chamber, and the second longitudinal portion 3675B extends between 55% and 65% of the total length of the folding chamber.

[0058] In one aspect of the seventh embodiment and in conjunction with any other aspect herein, this disclosure provides that a non-planar surface includes a first longitudinal portion, a second longitudinal portion, and a third longitudinal portion, the second longitudinal portion being disposed between the first longitudinal portion and the third longitudinal portion, the first longitudinal portion and the third longitudinal portion being configured to be closer to the centerline of the compression chamber than the second longitudinal portion, such that the first longitudinal portion and the third longitudinal portion are configured to exert a higher radial force on the implantable medical device than the second longitudinal portion.

[0059] In one aspect of the seventh embodiment and in conjunction with any other aspect herein, this disclosure provides that the first longitudinal portion and the third longitudinal portion each taper gradually toward the second longitudinal portion along their length.

[0060] In one aspect of the seventh embodiment and in conjunction with any other aspect herein, this disclosure provides that the first longitudinal portion and the third longitudinal portion each extend to between 5% and 15% of the total length of the compression chamber.

[0061] In one aspect of the seventh embodiment and in conjunction with any other aspect thereof, this disclosure provides that a first longitudinal portion extends between 55% and 65% of the total length of the folding chamber, a second longitudinal portion extends between 25% and 35% of the total length of the folding chamber, and a third longitudinal portion extends between 5% and 15% of the total length of the folding chamber.

[0062] In one aspect of the seventh embodiment and in conjunction with any other aspect herein, this disclosure provides that the third longitudinal portion gradually tapers towards the second longitudinal portion along its length.

[0063] In one aspect of the seventh embodiment and in conjunction with any other aspect herein, this disclosure provides that a non-planar surface includes a first longitudinal portion, a second longitudinal portion, a third longitudinal portion, and a fourth longitudinal portion, the second longitudinal portion being disposed between the first longitudinal portion and the third longitudinal portion, and the third longitudinal portion being disposed between the second longitudinal portion and the fourth longitudinal portion, the first longitudinal portion and the fourth longitudinal portion being configured to be closer to the centerline of the compression chamber than each of the second longitudinal portion and the third longitudinal portion, such that the first longitudinal portion and the fourth longitudinal portion are configured to apply a higher radial force to the implantable medical device than each of the second longitudinal portion and the third longitudinal portion, and the second longitudinal portion being configured to be closer to the centerline of the compression chamber than the third longitudinal portion, such that the second longitudinal portion is configured to apply a higher radial force to the implantable medical device than the third longitudinal portion.

[0064] In one aspect of the seventh embodiment and in conjunction with any other aspect thereof, this disclosure provides that a first longitudinal portion gradually tapers along its length toward a second longitudinal portion, and a fourth longitudinal portion gradually tapers along its length toward a third longitudinal portion.

[0065] In one aspect of the seventh embodiment and in conjunction with any other aspect thereof, this disclosure provides that a first longitudinal portion extends to between 2% and 8% of the total length of the folding chamber, a second longitudinal portion extends to between 50% and 60% of the total length of the folding chamber, a third longitudinal portion extends to between 25% and 35% of the total length of the folding chamber, and a fourth longitudinal portion extends to between 5% and 15% of the total length of the folding chamber.

[0066] According to an eighth embodiment herein, this disclosure provides a method for changing an expandable medical device from an uncompressed state to a compressed state. The method includes loading the expandable medical device into a folding chamber of a folding device, and actuating a handle of the folding device to operate the folding device. The folding chamber is defined by a plurality of folding elements, each folding element including a non-planar surface forming a partial folding groove. Actuation of the handle reduces the volume of the folding chamber to change the expandable medical device from an uncompressed state to a compressed state, and the non-planar surfaces apply uneven radial compression along the length of the implantable medical device during operation of the folding device.

[0067] In one aspect of the eighth embodiment and in conjunction with any other aspect herein, this disclosure provides that a first radial force is applied to a first segment of an implantable medical device through a first longitudinal portion of a non-planar surface, and a second radial force is applied to a second segment of the implantable medical device through a second longitudinal portion of a non-planar surface, the second radial force being greater than the first radial force.

[0068] In one aspect of the eighth embodiment and in conjunction with any other aspect herein, this disclosure provides that the second segment of the implantable medical device is denser than the first segment of the implantable medical device.

[0069] In one aspect of the eighth embodiment and in conjunction with any other aspect herein, this disclosure provides that the second segment of the implantable medical device includes a valve.

[0070] In one aspect of the eighth embodiment and in conjunction with any other aspect herein, this disclosure provides that a first segment of the implantable medical device includes a plurality of openings formed in a stent of the implantable medical device, the plurality of openings being configured to provide coronary artery access upon in situ implantation.

[0071] In one aspect of the eighth embodiment and in conjunction with any other aspect herein, this disclosure provides that the implantable medical device has a substantially uniform profile in a compressed state.

[0072] In one aspect of the eighth embodiment and in conjunction with any other aspect herein, this disclosure provides that the second segment of the implantable medical device is one of the inflow end and the outflow end of the implantable medical device.

[0073] In one aspect of the eighth embodiment and in conjunction with any other aspect herein, this disclosure provides that the non-planar surface includes a first longitudinal portion and a second longitudinal portion, the second longitudinal portion being configured to be closer to the centerline of the compression chamber than the first longitudinal portion, such that the second longitudinal portion is configured to apply a higher radial force to the implantable medical device compared to the first longitudinal portion.

[0074] In one aspect of the eighth embodiment and in conjunction with any other aspect thereof, this disclosure provides that a first longitudinal portion extends between 35% and 45% of the total length of the folding chamber, and a second longitudinal portion extends between 55% and 65% of the total length of the folding chamber.

[0075] In one aspect of the eighth embodiment and in conjunction with any other aspect herein, this disclosure provides that a non-planar surface includes a first longitudinal portion, a second longitudinal portion, and a third longitudinal portion, the second longitudinal portion being disposed between the first longitudinal portion and the third longitudinal portion, the first longitudinal portion and the third longitudinal portion being configured to be closer to the centerline of the compression chamber than the second longitudinal portion, such that the first longitudinal portion and the third longitudinal portion are configured to exert a higher radial force on the implantable medical device than the second longitudinal portion.

[0076] In one aspect of the eighth embodiment and in conjunction with any other aspect herein, this disclosure provides that the first longitudinal portion and the third longitudinal portion each taper gradually toward the second longitudinal portion along their length.

[0077] In one aspect of the eighth embodiment and in conjunction with any other aspect herein, this disclosure provides that the first longitudinal portion and the third longitudinal portion each extend to between 5% and 15% of the total length of the compression chamber.

[0078] In one aspect of the eighth embodiment and in conjunction with any other aspect thereof, this disclosure provides that a first longitudinal portion extends between 55% and 65% of the total length of the folding chamber, a second longitudinal portion extends between 25% and 35% of the total length of the folding chamber, and a third longitudinal portion extends between 5% and 15% of the total length of the folding chamber.

[0079] In one aspect of the eighth embodiment and in conjunction with any other aspect thereof, this disclosure provides that the third longitudinal portion gradually tapers toward the second longitudinal portion along its length.

[0080] In one aspect of the eighth embodiment and in conjunction with any other aspect herein, this disclosure provides that a non-planar surface includes a first longitudinal portion, a second longitudinal portion, a third longitudinal portion, and a fourth longitudinal portion, the second longitudinal portion being disposed between the first longitudinal portion and the third longitudinal portion, and the third longitudinal portion being disposed between the second longitudinal portion and the fourth longitudinal portion, the first longitudinal portion and the fourth longitudinal portion being configured to be closer to the centerline of the compression chamber than each of the second longitudinal portion and the third longitudinal portion, such that the first longitudinal portion and the fourth longitudinal portion are configured to apply a higher radial force to the implantable medical device than each of the second longitudinal portion and the third longitudinal portion, and the second longitudinal portion being configured to be closer to the centerline of the compression chamber than the third longitudinal portion, such that the second longitudinal portion is configured to apply a higher radial force to the implantable medical device than the third longitudinal portion.

[0081] In one aspect of the eighth embodiment and in conjunction with any other aspect thereof, this disclosure provides that a first longitudinal portion gradually tapers along its length toward a second longitudinal portion, and a fourth longitudinal portion gradually tapers along its length toward a third longitudinal portion.

[0082] In one aspect of the eighth embodiment and in conjunction with any other aspect thereof, this disclosure provides that a first longitudinal portion extends to between 2% and 8% of the total length of the folding chamber, a second longitudinal portion extends to between 50% and 60% of the total length of the folding chamber, a third longitudinal portion extends to between 25% and 35% of the total length of the folding chamber, and a fourth longitudinal portion extends to between 5% and 15% of the total length of the folding chamber.

[0083] Details of one or more aspects of this disclosure are set forth in the accompanying drawings and the following description. Other features, objects, and advantages of the technology described in this disclosure will become apparent from the specification, drawings, and claims. Attached Figure Description

[0084] The foregoing and other features and advantages of this disclosure will become apparent from the following description of embodiments illustrated in the accompanying drawings. The drawings, which are incorporated herein and constitute a part of this specification, further serve to explain the principles of this disclosure and to enable those skilled in the art to make and use embodiments of this disclosure. The drawings are not drawn to scale.

[0085] Figures 1A to 1E A different view is depicted of another example of a flip-top folding device for use with a medical device according to embodiments of this document.

[0086] Figure 1A The embodiments described herein are illustrated. Figures 1A to 1E A perspective view of the side of the top housing of the folding device.

[0087] Figure 2A Detailed views of the components of the first housing of the top shell of the folding device according to embodiments herein are depicted.

[0088] Figure 2B The embodiments described herein are illustrated. Figures 1A to 1E A perspective view of the side of the base housing of the folding device.

[0089] Figure 2C The embodiments described herein are illustrated. Figure 2A A magnified perspective view of the side of the top housing of the folding device.

[0090] Figures 3A to 3H The embodiments described herein are illustrated. Figures 1A to 1E Several views of the folding element.

[0091] Figure 4 The embodiments described herein are illustrated. Figures 1A to 1E A three-dimensional diagram of the rod.

[0092] Figure 5A The embodiments described herein are illustrated. Figures 1A to 1E A three-dimensional view of the top cam of the folding device.

[0093] Figure 5B The embodiments described herein are illustrated. Figures 1A to 1E A three-dimensional view of the bottom cam of the folding device.

[0094] Figures 6A to 6C The embodiments described herein are illustrated. Figures 1A to 1E Several views of the handle of the folding device.

[0095] Figure 7 The embodiments described herein are illustrated. Figures 1A to 1E The operation of the pleating device.

[0096] Figures 8A to 8F A different view is depicted of another example of a compression device used with a medical device according to embodiments of this article.

[0097] Figure 9A The embodiments described herein are illustrated. Figures 8A to 8F A three-dimensional view of the side of the casing of the folding device.

[0098] Figure 9B The embodiments described herein are illustrated. Figure 9A A magnified 3D view of the side of the outer shell.

[0099] Figure 10A and Figure 10B The embodiments described herein are illustrated. Figures 8A to 8F Several views of the handle of the folding device.

[0100] Figures 11A to 11D The embodiments described herein are illustrated. Figures 8A to 8F The operation of the pleating device.

[0101] Figure 12A and Figure 12B A different view is depicted of another example of a compression device used with a medical device according to embodiments of this article.

[0102] Figure 13A and Figure 13B The embodiments described herein are illustrated. Figure 12A and Figure 12B A three-dimensional view of the side of the casing of the folding device.

[0103] Figure 13C and Figure 13D The embodiments described herein are illustrated. Figure 13A and Figure 13B A magnified 3D view of the side of the outer shell.

[0104] Figure 14A and Figure 14B The embodiments described herein are illustrated. Figure 12A and Figure 12B Several views of the cam of the pressure folder.

[0105] Figure 15A and Figure 15B The embodiments described herein are illustrated. Figure 12A and Figure 12B Several views of the bar.

[0106] Figures 16A to 16D The embodiments described herein are illustrated. Figure 12A and Figure 12B Several views of the folding element.

[0107] Figures 17A to 17D The embodiments described herein are illustrated. Figure 12A and Figure 12B Several views of the handle of the folding device.

[0108] Figures 18A to 18E The embodiments described herein are illustrated. Figure 12A and Figure 12B The operation of the pleating device.

[0109] Figures 19A to 19G A different view is depicted of another example of a flip-top folding device for use with a medical device according to embodiments of this document.

[0110] Figure 20A The embodiments described herein are illustrated. Figures 19A to 19G A perspective view of the side of the top housing of the folding device.

[0111] Figure 20B The embodiments described herein are illustrated. Figures 19A to 19G A perspective view of the side of the base housing of the folding device.

[0112] Figure 20C An enlarged perspective view of the folding element groove and a portion of the central cavity according to an embodiment of this document is depicted.

[0113] Figures 21A to 21H The embodiments described herein are illustrated. Figures 19A to 19G Several views of the folding element.

[0114] Figure 22 The embodiments described herein are illustrated. Figures 19A to 19GSide view of the top cam and base cam of the pressure folder.

[0115] Figure 23 The embodiments described herein are illustrated. Figures 19A to 19G The handle of the folding device.

[0116] Figure 24A and Figure 24B A different view is depicted of another example of a compression device used with a medical device according to embodiments of this article.

[0117] Figure 25A , Figure 25B and Figure 25C The embodiments according to this document are described respectively. Figure 24A and Figure 24B A perspective view, a side view, and an exploded view of the handle and gear subassembly of the folding device.

[0118] Figure 26A and Figure 26B The embodiments according to this document are described respectively. Figure 24A and Figure 24B Side view and perspective view of the outer casing of the folding device.

[0119] Figure 27A and Figure 27B The embodiments according to this document are described respectively. Figure 24A and Figure 24B Side view and perspective view of the cam of the pressure folder.

[0120] Figure 28A and Figure 28B The embodiments according to this document are described respectively. Figure 24A and Figure 24B A perspective view and a front view of the rod.

[0121] Figure 29A , Figure 29B and Figure 29C The embodiments described herein are illustrated. Figure 24A and Figure 24B Different views of the folding element of the folding device.

[0122] Figure 30A and Figure 30B The embodiments described herein are illustrated by Figure 29A , Figure 29B and Figure 29C End view and side view of the folding chamber formed by the folding elements.

[0123] Figure 31A and Figure 31B A description of another embodiment of the invention for use Figure 24A and Figure 24BA perspective view and a front view of the folding element of the folding device.

[0124] Figure 32A and Figure 32B The embodiments described herein are illustrated by Figure 31A and Figure 31B End view and side view of the folding chamber formed by the folding elements.

[0125] Figure 33A and Figure 33B A description of another embodiment of the invention for use Figure 24A and Figure 24B A perspective view and a front view of the folding element of the folding device.

[0126] Figure 34A and Figure 34B The embodiments described herein are illustrated by Figure 33A and Figure 33B End view and side view of the folding chamber formed by the folding elements.

[0127] Figure 35A and Figure 35B A description of another embodiment of the invention for use Figure 24A and Figure 24B A perspective view and a front view of the folding element of the folding device.

[0128] Figure 36A and Figure 36B An end view and a side view of a folding chamber formed by the folding elements of Figures 42A and 42B according to an embodiment of this document are depicted.

[0129] Figure 37A and Figure 37B A description of another embodiment of the invention for use Figure 24A and Figure 24B A perspective view and a front view of the folding element of the folding device.

[0130] Figure 38A and Figure 38B End and side views of a folding chamber formed by the folding elements of Figures 44A and 44B, according to embodiments herein, are depicted.

[0131] Figures 39A to 39D The embodiments described herein are illustrated. Figure 24A and Figure 24B The operation of the pleating device.

[0132] Figure 40A The embodiments described herein are illustrated with Figure 24A and Figure 24B A side view of an artificial heart valve used in conjunction with a compression device.

[0133] Figure 40BDepicting Figure 40A A top view of an artificial heart valve. Detailed Implementation

[0134] Specific embodiments of this disclosure will now be described with reference to the accompanying drawings. The following detailed description of examples of embodiments is not intended to limit the technology or its applications and uses. While the embodiments described herein are in the context of pleats, the technology can also be used with other devices. Furthermore, one should not be bound by any express or implied theory presented in the foregoing technical fields, background art, summary of the invention, or the following detailed description.

[0135] The embodiments disclosed herein relate to a folding device for mounting an implantable medical device onto a delivery device and for converting the implantable medical device from an expanded state to a compressed state. In some embodiments, the flip-top folding device includes a top iris housing and a base iris housing. The top iris housing can rotate away from the base iris housing to expose a slot for mounting and positioning the implantable medical device and the delivery device. When closed, the slot in the base iris housing and the corresponding slot in the top iris housing form a folding chamber surrounding the expandable medical device. The flip-top folding device can then be actuated to reduce the volume of the folding chamber by an iris-type displacement process of the flap. To reduce the volume of the folding chamber, the folding device includes a plurality of folding elements. The plurality of folding elements form a folding chamber surrounding the expandable medical device. The folding device can be actuated to reduce the volume of the folding chamber by an iris-type displacement process of the folding elements. The displacement of the folding elements is controlled by a handle actuated by a cam. The cam includes a plurality of helical grooves configured to receive a connecting pin of the folding element. The function of the cam is to convert the rotational motion of the cam into the approximate linear motion of the pressing element.

[0136] Figures 1A to 1E An example of a flap-type folding device 800 according to one embodiment of this document is shown. Those skilled in the art will recognize that... Figures 1A to 1E An example of a pleater is shown, and Figures 1A to 1E The existing parts shown can be removed and / or additional parts can be added to the flap folder 800.

[0137] Figure 1A This is a side view of the first side of the flip-top folding mechanism 800. (See image.) Figure 1A The flap-type folding device 800 shown includes a handle 802, a top housing 804 (or a top iris housing), and a base housing 806 (or a base iris housing). The top housing 804 includes a first outer shell 810, while the base housing 806 includes a first outer shell 812. The top housing 804 and the base housing 806 are coupled at a pivot connection 808. The pivot connection 808 allows the top housing 804 to rotate about an axis R ( ) of rotation of the pivot connection 808. Figure 1C (As shown) Rotate away from the base housing to make the angle between the top housing 804 and the base housing 806... θ Increase or decrease. The pivot connection 808 is configured to allow the top housing 804 and the base housing 806 to move relative to each other from the open state (e.g., Figures 1A to 1C (as shown) becomes the off state (e.g.) Figure 7 (As shown). Although not shown, the flap folder 800 can be connected to the base or other structure to provide support for the flap folder 800.

[0138] As described herein, the open state of the flap-type folding mechanism 800 defines any angle between the top housing 804 and the base housing 806. θ This angle allows the user to insert the implantable medical device and / or delivery device into the flap-type folder 800 and allows the user to view the insertion to ensure proper alignment of the implantable medical device and delivery device. Similarly, as described herein, the closed state defines either angle between the top housing 804 and the base housing 806. θ Within this angle, the function of the flip-type folding device 800 is to compress and fold the implantable medical device or mount it onto the delivery device. For example, in an embodiment, when in the open state, the angle between the top housing 804 and the base housing 806 is... θ It can be in the range of approximately 45 degrees to approximately 180 degrees. Similarly, for example, in an embodiment, the angle between the top housing 804 and the base housing 806 when in the closed state... θ It can be approximately 0 degrees Celsius.

[0139] Figure 1B The second side of the flap-type folding device 800, opposite to the first side, is shown. Figure 1B In the view, the outer casing on the second side of the flap-type folding mechanism 800 is removed to reveal the internal components of the flap-type folding mechanism 800. As shown, the top casing 804 includes a first casing 810 and a second casing (removed in this figure). The base casing 806 includes a first casing 812 and a second casing (removed in this figure). The top casing 804 and the base casing 806 include a plurality of folding elements 814. Figure 1C (This is an enlarged perspective view of the top housing 804 and the base housing 806.) Further, the pressure-bending element 814 of the top housing 804 forms a top pressure-bending groove 816. The pressure-bending element 814 of the base housing 806 forms a bottom pressure-bending groove 818. When in the closed state, the top pressure-bending groove 816 and the bottom pressure-bending groove 818 form a pressure-bending chamber 820, as shown... Figure 7 (It is shown as a perspective view of the flip-top folding mechanism 800 in the closed state.)

[0140] In an embodiment, the pivot connection 808 can be any type of mechanical or electromechanical connection that allows the top housing 804 and the base housing 806 to move relative to each other. For example, the pivot connection 808 may include one or more of hinges, buckles, rivets, pivot pins, pivot couplings, shafts, movable hinges, etc. In an embodiment, the pivot connection 808 may include motion-assisting devices to provide forces that assist the movement of the top housing 804 and the base housing 806 relative to each other. For example, the pivot connection 808 may include springs, motors, etc.

[0141] In some embodiments, such as Figure 1C As shown, the first outer casing 810 of the top casing 804 may include a protrusion 819 extending from the rear of the first outer casing 810. The protrusion 819 includes a pivot connection hole 821 (described below). Figure 2A (As shown). The first outer shell 812 of the base housing 806 may include a protrusion 822 extending from the rear of the first outer shell 812. The protrusion 822 includes a pivot connection hole 823 (described below). Figure 2B (As shown). When the snap fasteners 819 and 822 (and the snap fasteners of the second outer shell of the top housing 804 and the base housing 806) engage, the pivot connection holes 821 and 823 can form concentric holes that serve as pivot connection portions 808 when a pin, rivet, bolt, screw, or other connecting mechanism is inserted into these concentric holes. For example, as described in further detail below, the pivot connection portion 808 may include a pin positioned in a corresponding concentric hole formed by the pivot connection hole 821 of the first housing 810, the pivot connection hole 823 in the first housing 812, and the pivot connection portions of the second outer shell of the top housing 804 and the base housing 806. For example, the pin may be a concealed pin, bolt, etc. The pin may be shaped to a diameter such that a corresponding circular opening is retained and the pin operates as a fulcrum.

[0142] In one embodiment, the top housing 804 and the base housing 806 may be separate components that can be detachably attached at the pivot connection 808 to form a flap-type folder 800. In another embodiment, the top housing 804 and the base housing 806 may be part of a single component, for example, folding toward each other via a movable hinge between them to form an integrated flap-type folder 800. The top housing 804 and the base housing 806 may be formed of any suitable material, such as, but not limited to, aluminum, stainless steel, or polymeric materials. Although the flap-type folder 800 is described as pivoting at the pivot connection 808, those skilled in the art will appreciate that the top housing 804 and the base housing 806 may move relative to each other using other types of process and mechanical connections.

[0143] like Figure 1CAs shown, the folding element 814 is arranged to partially overlap between the top housing 804 and the base housing 806 in a first direction. In an embodiment, the folding element 814 of the top housing 804 is arranged to partially overlap to form a top folding groove 816 at the distal end of the folder (e.g., see reference). Figures 3A to 3D (Described as follows). The folding element 814 of the base housing 806 is arranged to partially overlap to form a bottom folding groove 818 at the distal end of the folding element 814 (e.g., see reference). Figures 3A to 3D (Described as follows). When the flip-top folding device 800 is in the closed state, the top folding groove 816 and the bottom folding groove 818 define the folding chamber 820. That is, when in the closed state, the folding elements 814 of the top housing 804 and the folding elements 814 of the base housing 806 form cylindrical surfaces at the overlapping ends of the folding elements 814, having a cylindrical cavity through the center, thereby defining the folding chamber 820.

[0144] In an embodiment, the folding element 814 may be removable from the top housing 804 and / or the base housing 806. Therefore, the folding element 814 may be interchangeable with other types of folding elements configured to adapt to different sizes and / or configurations of implantable medical devices and / or delivery devices. The folding element 814 may be formed of any suitable material, such as, but not limited to, aluminum, stainless steel, or polymeric materials.

[0145] like Figure 1D (As shown in the enlarged perspective view of the top housing 804), the first outer shell 810 of the top housing 804 includes a top cam 824. The handle 802 is connected to the top cam 824, as described below. Figure 5A and Figures 6A to 6C Further described. The top cam 824 is also connected to the folding element 814 via a rod 826. Each rod 826 extends from the top cam 824 to the middle region of one of the folding elements 814, as described below. Figures 3A to 3D and Figure 4 The top cam 824 is used to transmit the rotational motion of the handle 802 to the pressing element 814 via the lever 826.

[0146] like Figure 1E (As shown in the enlarged perspective view of the base housing 806), the first outer shell 812 of the base housing 806 includes a bottom cam 828. The bottom cam 828 is also connected to the pressing element 814 via rods 826. Each rod 826 extends from the bottom cam 828 to the middle region of a pressing element 814, as described below. Figures 3A to 3D and Figure 4As described, the bottom cam 828 functions to transmit the movement of the handle 802 (via the movement of the top cam 824) to the folding element 814 via the lever 826. When in the closed state, the bottom cam 828 engages with the top cam 824, causing the top cam 824 and the bottom cam 828 to rotate together and function as a single cam. That is, when engaged, the top cam 824 and the bottom cam 828 form a cylindrical ring within the flap-type folding element 800. An example of the top cam 824 and the bottom cam 828 will be referenced. Figure 5A and Figure 5B Further details are as follows.

[0147] When in the closed state, the folding element 814 is displaced by the movement of the handle 802. That is, as the handle 802 moves, the top cam 824 and the bottom cam 828 rotate and are used to convert the rotational movement of the handle 802 into the linear movement of the folding element 814 via the lever 826, as described in further detail below. Therefore, the folding element 814 of the top housing 804 and the base housing 806 acts as an iris, causing the volume of the folding chamber 820 to decrease or increase by the movement of the handle 802. Figure 7 As shown, when in the closed state, the compression chamber 820 can define an approximately cylindrical volume. Although the compression chamber 820 is described above as defining a cylindrical volume, those skilled in the art will recognize that the shape and size of the compression element 814 can be varied to produce volumes of different shapes according to the needs of the implantable medical device being compressed and positioned.

[0148] In this embodiment, the flip-type folding device 800 functions to convert the implantable medical device from its uncompressed state to its compressed state. Similarly, the flip-type folding device 800 functions to fold or mount the implantable medical device onto the delivery device. In operation, the implantable medical device is mounted in the bottom folding groove 818 and positioned in a direction parallel to the axis of rotation R of the top housing 804 and the base housing 806. The delivery device can also be positioned and aligned relative to the implantable medical device. That is, the implantable medical device can be positioned around the delivery device. The flip-type folding device 800 is then changed from an open state to a closed state, and the handle 802 is actuated to convert the implantable medical device from its uncompressed state to its compressed state and mount the implantable medical device onto the delivery device.

[0149] To operate the flip-type folding device 800, a force can be applied to the handle 802 in the direction of the base housing 806. When a force is applied, the top cam 824 and the bottom cam 828 rotate in the direction of the force applied to the handle 802. The rotation of the top cam 824 and the bottom cam 828 causes the lever 826 to shift inward. The inward movement of the lever 826 causes the folding element 814 of the top housing 804 and the base housing 806 to shift inward, thereby producing an iris effect. That is, the inward movement of the lever 826 is transmitted to the folding element 814, thereby causing the folding element to shift inward, as described in further detail below. As a result, the volume of the folding chamber 820 decreases, and the folding element 814 applies a compressive force to the outer surface of the implantable medical device to fold the expandable medical device from its uncompressed state to its compressed state. For example, if the implantable medical device is circular or cylindrical, when force is applied to the handle 802, the pressure-bending element 814 applies force from multiple different directions on the surface of the implantable medical device, thereby compressing the implantable medical device.

[0150] The flip-top folding device 800 can be used for any type of implantable medical device that requires conversion from an uncompressed to a compressed state. In embodiments, the folding device can be applied to any implantable medical device that requires on-site folding of the medical device to be implanted onto a catheter, such as organic tissue containing a valve repair device. In embodiments, the folding device 800 can be used with balloon-expandable medical devices and / or mechanically expandable medical devices. For example, the flip-top folding device 800 can be used for implantable medical devices that require transluminal delivery, for example, via a catheter and need to be fitted onto or into a catheter. In this example, the implantable medical device may include a heart valve prosthesis comprising a stent or frame and an artificial valve attached within the frame. The stent / frame can be folded to have a small profile, allowing the prosthesis to be delivered in a compressed state through a blood vessel to a target location, and then (e.g., via a balloon of the delivery device) expanded at the target location to replace the native heart valve.

[0151] By opening the flip-top folding device 800 to a sufficiently large angle to view the bottom folding groove 818, the user can correctly position and locate the heart valve prosthesis relative to the catheter. For example, when a balloon catheter (a non-folded stent / frame with the heart valve prosthesis) is placed within the flip-top folding device 800, the user can visually ensure that the prosthesis is correctly positioned above the balloon of the catheter before continuing the folding operation. The open top insertion design of the flip-top folding device 800 provides greater visibility for the insertion and alignment of implantable medical devices and delivery devices, as well as for rapid fine-tuning. That is, because the implantable medical device and delivery device are easily accessible by opening the flip-top folding device 800, the relative alignment of the implantable medical device and delivery device can be monitored and adjusted without removing them from the flip-top folding device 800. For example, heart valve prostheses are typically inserted onto the delivery device or catheter during implantation surgery (e.g., by medical personnel in a hospital). Proper alignment and placement of the prosthesis onto the delivery catheter are crucial; errors can lead to the discarding of misaligned prostheses, which is both wasteful and costly. The flip-top folding device 800 provides a simple and accurate procedure for folding such heart valve prostheses onto balloon catheters in a hospital setting. Furthermore, the flip-top folding device 800 eliminates the complex geometry and machining typically required for iris folding devices.

[0152] return Figure 1C and Figure 1D The handle 802 can be formed as a separate component attached to the top cam 824. In other embodiments, the handle 802 can be integrated with the top cam 824 to form a single component. In embodiments, the shape, size, design, and / or construction of the handle 802 can be adapted to different press-and-fold operations. For example, the handle 802 can extend and include a pivot point for increasing leverage during the press-and-fold operation. Similarly, the handle 802 can include a foot pedal to facilitate pulling the handle 802 down. The handle 802 can be formed of any suitable material, such as, but not limited to, aluminum, stainless steel, or polymeric materials.

[0153] In one embodiment, the top housing 804 may include a handle locking mechanism that locks the handle 802 in the open position (e.g., the folding chamber 820 is opened to its maximum diameter). The top housing 804 and / or the base housing 806 may include a housing locking mechanism that locks the top housing 804 and the base housing 806 together in a closed state (e.g., the top housing 804 and the base housing 806 are together). When the handle 802 is locked by the handle locking mechanism, the flip-top folder 800 can be opened by pivoting the top housing 804 away from the base housing 806 (e.g., the top folding groove 816 and the bottom folding groove 818 separate). During the folding operation, the top housing 804 can be closed, for example, using the handle 802, and the top housing 804 and the base housing 806 can be locked in a closed state, for example, the top housing 804 and the base housing 806 are together. The handle 802 can then be unlocked by releasing the handle locking mechanism to perform the folding operation. The double locking mechanism prevents the top folding groove 816 of the top housing 804 or the bottom folding groove 818 of the base housing 806 from moving to the closed position while the other half remains in the open position.

[0154] In an embodiment, the flip-type folding device 800 may further include one or more stops that physically stop the folding device handle 802 at one or more predetermined positions corresponding to one or more predetermined diameters to which the implanted medical device can be folded or compressed. In some embodiments, the flip-type folding device 800 may include a first stop and a second stop, for example... Figure 12B The first stop 1950 and the second stop 1952 are shown and described in detail below. The first and second stops provide surfaces that stop the handle 802 from moving in the downward direction. The first and second stops provide a stopping position for the handle 802 corresponding to a predetermined diameter of the compression chamber 820. That is, the first and second stops serve as physical stops to allow the implantable medical device to be compressed to a predetermined diameter or degree of compression. For example, the first stop may function to allow the implantable medical device to be partially compressed. Similarly, for example, the second stop may function to allow the implantable medical device to be fully compressed. The first and second stops may be detachably coupled to the top housing 804 and / or the base housing 806. Therefore, the first top and / or second stops can be added and / or removed to allow the implantable medical device to be compressed to a predetermined diameter.

[0155] Although the components of the flip-type folding device 800 are described above using the terms "first," "second," "proximal," and "distal," those skilled in the art will recognize that the use of these terms is intended only to indicate the components of the flip-type folding device 800 and does not limit any preferred or sequential arrangement of the components of the flip-type folding device 800. Similarly, for example, although the implantable medical device is described as being positioned in the bottom folding groove 818 during operation, in embodiments, the implantable medical device may be positioned in the top folding groove 816.

[0156] Figure 2A Detailed views of the components of the first outer casing 810 of the top casing 804 are shown. Those skilled in the art will recognize that... Figure 2A An example of a housing of the top shell 804 is shown, and Figure 2A The existing components shown can be removed and / or additional components can be added to the first housing 810. Furthermore, although only the first housing 810 is described in detail below, those skilled in the art will recognize that the top housing 804 includes a second housing, which may include components similar to... Figure 2A The same components are shown. For example, the second housing can be formed as a "mirror image" of the first housing 810 and can be coupled to the first housing 810 to form the top housing 804.

[0157] like Figure 2A As shown, the first housing 810 includes a side plate 902 having an inner surface 903 and an outer surface (not shown) opposite to the inner surface. In an embodiment, the side plate 902 may be configured as a semi-cylindrical plate with a semi-cylindrical opening 908. The semi-cylindrical opening 908 opens into a top folding groove 816 formed by a folding element 814. Folding element grooves 904 are formed on the inner surface 903 of the side plate 902. Each folding element groove 904 may be formed as a rectangular recess or slot extending inward from the outer radius of the side plate 902 toward the semi-cylindrical opening 908. The folding element grooves 904 may be equidistantly positioned along an arcuate arc along the inner surface 903 of the side plate 902. The folding element grooves 904 are coupled to a central cavity 906 formed on the inner surface 903 of the side plate 902. The central cavity 906 may be formed as a semi-circular cavity with a depth approximately the same as the folding element grooves 904.

[0158] Side plate 902 also includes a cam groove 910 formed within an inner surface 903 of side plate 902. Cam groove 910 extends in a semi-circular arc from the bottom surface 911 of side plate 902. Cam groove 910 can be configured to receive and retain a top cam 824 and is configured to allow the top cam 824 to move (e.g., rotate) within the top housing 804. Cam groove 910 can be formed such that its depth is less than that of the pressure element groove 904. Cam groove 910 can be formed such that its width adapts to the top cam 824.

[0159] Side panel 902 also includes a handle stop 912 extending from the inner surface 901 of side panel 902. The handle stop 912 may extend arcuately from the latch 819 to a stop position partially around the circumference of side panel 902, thereby defining a handle opening 905. The handle stop 912 can function as a stop for handle 802 when it is in motion. Side panel 902 also includes a latch 819 extending from the side surface of side panel 902. Although Figure 2A The buckle 819 is shown to form an integral part together with the side plate 902, but those skilled in the art will recognize that the buckle 819 may be a separate part connected to the side plate 902.

[0160] Figure 2B Detailed views of the components of the first outer shell 812 of the base housing 806 are shown. Those skilled in the art will recognize that... Figure 2B An example of the housing of the base housing 806 is shown, and Figure 2B The existing components shown can be removed and / or additional components can be added to the first housing 812. Furthermore, although only the first housing 812 is described in detail below, those skilled in the art will recognize that the base housing 806 includes a second housing, which may include components similar to... Figure 2B The same components are shown. For example, the second housing may be formed as a "mirror image" of the first housing 812 and may be coupled to the first housing 812 to form the base housing 806.

[0161] like Figure 2B As shown, the first housing 812 includes a side plate 952 having an inner surface 953 and an outer surface (not shown). In an embodiment, the side plate 952 may be configured as a semi-cylindrical plate with a semi-cylindrical opening 958. The semi-cylindrical opening 958 leads to a bottom folding groove 818 formed by a folding element 814. Folding element grooves 954 are formed on the inner surface 953 of the side plate 952. Each folding element groove 954 may be formed as a rectangular recess or slot extending inward from the outer radius of the side plate 952 toward the semi-cylindrical opening 958. The folding element grooves 954 may be equidistantly positioned along an arcuate arc along the inner surface 953 of the side plate 952. The folding element grooves 954 are connected to a central cavity 956 formed on the inner surface 953 of the side plate 952. The central cavity 956 may be formed as a semi-circular cavity with a depth approximately the same as the folding element grooves 954.

[0162] Side plate 952 also includes a cam groove 960 formed within an inner surface 953 of side plate 952. Cam groove 960 extends in a semi-circular arc from the top surface 961 of side plate 952. Cam groove 960 can be configured to receive and retain a bottom cam 828 and is configured to allow the bottom cam 828 to move (e.g., rotate) within the base housing 806. Cam groove 960 can be formed such that its depth is less than that of the pressure-bending element groove 954. Cam groove 960 can be formed such that its width adapts to the bottom cam 828. Side plate 952 also includes a protrusion 822 extending from a side surface of side plate 952. Although Figure 2B The buckle 822 is shown to form an integral part together with the side plate 952, but those skilled in the art will recognize that the buckle 822 may be a separate part connected to the side plate 952.

[0163] The folding element groove 904 and the central cavity 906 can be configured to movably fix the folding element 814 within the top housing 904. Similarly, the folding element groove 954 and the central cavity 956 can be configured to movably fix the folding element 814 within the base housing 906. Figure 2C An enlarged perspective view of the pressure-bending element groove 904 and a portion of the central cavity 906 according to an embodiment of this document is shown. (Although referenced...) Figure 2C The construction and dimensions of the side plate 902 of the top housing 802 are described, but those skilled in the art will recognize that... Figure 2C The structure described herein can also be applied to the structure of the side plate 952 of the base housing 806.

[0164] like Figure 2C As shown, the side plate 902 is formed such that its radius extends from the center point 980 of the semi-cylindrical opening 908 to the side surface 982 of the side plate 902. In an embodiment, the radius line may be formed such that its length adapts to the folding element 814 and allows the folding element to move within the top housing 804. For example, the radius line may be formed such that its length is approximately 112.5 mm. In an embodiment, the folding element groove 904 of the side plate 902 is formed such that its width and depth accommodate the folding element 814 when the side plate 902 of the first housing 810 mates with the side plate of the second housing of the top housing 804. Similarly, the length of the folding element groove 804 formed by the side plate 902 and the radius formed by the central cavity 906 allow the folding element 814 to move and perform the folding operation of the flap-type folder 800. For example, the folding element groove 904 may be formed such that its width is approximately 15.0 mm. The folding element groove 904 may be formed such that its depth is approximately 8.5 mm from the inner surface 903 of the side plate 902. The pressure-bending element groove 904 can be formed to have a length of approximately 60.5 mm. The central cavity can be formed to have a radius of approximately 40.0 mm from the center point 980 to the distal end of the pressure-bending element groove 904.

[0165] As described above, the folding element groove 904 is formed around the side plate 902 in an arc shape. In the embodiment, each folding element groove 904 is angled with the adjacent folding element groove 904 in an arc shape. δ They are spaced apart. For example, the pressure-bending element slots 904 are spaced apart at an angle of approximately 30 degrees. δ In this embodiment, each pressure-bending element groove 904 can be aligned by offsetting an angle relative to the radius line of the side plate 902. For example, such as Figure 2C As shown, when measured at the intersection 986 of the radius line and the side wall 984 of the pressure element groove 904, the angle This can be defined as the angle between the radius line and the sidewall 984. This offset can cause the folding element 814 to move in a direction away from the center point 980. For example, the folding element groove 906 can be offset by an angle of approximately 15 degrees. .

[0166] Figures 3A to 3D Detailed views of the folding element 814 according to embodiments herein are shown. Those skilled in the art will recognize that... Figures 3A to 3D An example of a folded element is shown, and Figures 3A to 3D The existing components shown can be removed and / or additional components can be added to the folding element 814. Although only one folding element 814 is described in detail, those skilled in the art will recognize that the construction of the folding element 814 of the top housing 804 and the base housing 806 and the components it includes can be different from those of other folding elements. Figures 3A to 3D The pressure-bending element 814 described herein is the same.

[0167] like Figure 3A (As shown in a perspective view), the folding element 814 has a first leg 1002, a second leg 1004, and a folding protrusion 1006 connected to the first leg 1002 and the second leg 1004. The first leg 1002 and the second leg 1004 extend parallel to the long axis of the folding element 814 from the proximal end 1005 of the folding element 814 to the folding protrusion 1006. The first leg 1002 and the second leg 1004 are spaced apart and define a bar groove 1010. The folding protrusion 1006 extends from the first leg 1002 and the second leg 1004 to the distal end 1007 of the folding element 814. The folding protrusion 1006 is configured to define a folding space 1008. The folding space 1008 is configured to accommodate adjacent folding elements 814.

[0168] like Figure 3B(As shown in the side view), the folding element 814 includes a top surface 1026, a bottom surface 1028, and a distal surface 1030 formed at the ends of the first leg 1002 and the second leg 1004. The folding convex angle 1006 includes a first outer slope 1014 and a second outer slope 1016. The folding convex angle 1006 also includes a first inner slope 1018 and a second inner slope 1020. The intersection of the first leg 1002 and the folding convex angle 1006, and the intersection of the second leg 1004 and the folding convex angle 1006, form a hypotenuse 1022. Figure 3B (As shown in the bottom view) the first internal ramp 1018, the second internal ramp 1020 and the inclined side 1022 define the compression space 1008.

[0169] like Figure 3D (As shown in the top view), the first outer ramp 1014 and the second outer ramp 1016 form the surface between the top surface 1026 and the distal end 1007 and the bottom surface 1028. The first outer ramp 1014 and the second outer ramp 1016 may be formed at an angle relative to the top surface 1026 and the bottom surface 1028. Similarly, the first inner ramp 1018 and the second inner ramp 1020 may be formed at an angle relative to the top surface 1026 and the bottom surface 1028. The intersection of the first leg 1002 and the bending convex angle 1006 and the intersection of the second leg 1004 and the bending convex angle 1006 form a bevel 1022.

[0170] In an embodiment, the first leg 1002 and the second leg 1004 include inner surfaces 1032 and 1033 and a chamfer 1036 between the inner surfaces 1032 and 1033. A bar groove 1010 is defined by the inner surfaces 1032 and 1033, the chamfer 1036, and the proximal end 1034 of the folding convex angle 1006. The bar groove 1010 is configured to receive one of the bars 826. The folding element 814 also includes connecting holes 1012. Connecting holes 1012 are formed in the first leg 1002 and the second leg 1004. In an embodiment, the folding element 814 may include two connecting holes 1012 positioned relative to each other on the first leg 1002 and the second leg 1004. In an embodiment, the connecting holes 1012 may be configured to receive a pin passing through the two connecting holes and the connecting hole of the bar 826. For example, the pin may be a dowel pin, a bolt, etc. The pin can be formed to a diameter such that a corresponding circular opening is retained and the pin acts as a fulcrum for operation. The connecting hole 1012 serves to movably connect the folding element 814 to the bar 826. The bar 826 is engaged within the bar groove 1010. The bar groove 1010 allows the bar 826 to rotate relative to the folding element 814 during operation of the flip-type folding device 800.

[0171] In one embodiment, the folding element 814 is configured to work in combination to produce the iris effect of the flap folder 800. Figure 3E This is an enlarged side view of several folding elements 814 in the fully open position. As shown, the first outer ramp 1014 of the first folding element 814 rests against the first inner ramp 1018 of the second folding element 814, thereby forming an overlap. The overlap of the folding elements 814 defines a folding chamber 820. During operation, for example, when the actuation handle 802 moves downward (e.g.... Figure 3E (as shown in the counterclockwise direction), thus causing the cam ( Figure 3E The top cam 824 (shown) rotates. The rotation of the top cam 824 presses the lever 826 inward. The movement of the lever 826 presses the folding element 814 inward. Specifically, the folding element 814 generally moves inward toward the center of the folding chamber 820. As the folding element 814 moves inward, the space available for the folding element 814 to occupy decreases. Therefore, the space between the folding elements 814 decreases. Consequently, the first outer ramp 1014 of the first folding element 814 slides against the first inner ramp 1018 of the second folding element 814. Accordingly, the area of ​​the folding chamber 820 decreases.

[0172] In an embodiment, the width of each folding element 814 can range from approximately 25 mm to approximately 50 mm, and the length of each folding element 814 can range from approximately 1 mm to approximately 40 mm. The slopes (angles relative to the top surface 1026 and bottom surface 1028) of the first outer ramp 1014 and the second outer ramp 1016 can depend on the number of folding elements included in the flap-type folder 800. Similarly, the slopes (angles relative to the top surface 1026 and bottom surface 1028) of the first inner ramp 1018, the second inner ramp 1020, and the bevel 1022 can depend on the number of folding elements included in the flap-type folder 800. In an embodiment, the slope can be determined by dividing 360 degrees by the number of folding elements 814 in the flap-type folder 800. In an embodiment, the number of folding elements can range from 10 to 12. The first internal ramp 1018, the second internal ramp 1020, and the inclined side 1022 are configured to contact the adjacent folding element and produce an iris effect when the folding element is displaced.

[0173] Figures 3F to 3H An example of the dimensions of a folding element 814 with a 30 mm construction according to an embodiment of this document is shown. For clarity, reference numerals for the folding element 814 have been omitted and can be found in... Figures 3A to 3D Found in. Table 1 below describes Figures 3F to 3HThe dimensions are shown and exemplary dimensional values ​​are provided. Those skilled in the art will recognize that the dimensional values ​​are examples and that the folding element 814 may have different dimensional values ​​based on the specific construction and folding application of the flap folder 800.

[0174] Table 1

[0175]

[0176] Figure 4 An example of a rod 826 is shown. As shown, the rod 826 is formed as a rectangular rod portion 1102 with connecting holes 1104. The rectangular rod portion 1102 may include a circular end portion 1106 formed in a semi-cylindrical shape. One of the connecting holes 1104 serves to movably connect a bending element 814 to the rod 826. In an embodiment, the first connecting hole in the connecting holes 1104 is aligned with a connecting hole 1012 of the bending element 814. As described above, the first connecting hole in the connecting holes 1104 can be configured to receive a pin passing through both connecting holes 1012 of the bending element 814. For example, the pin can be a concealed pin, bolt, etc. The pin can be formed to a diameter such that a corresponding circular opening is retained and the pin operates as a fulcrum.

[0177] In an embodiment, the second connecting hole in connecting hole 1104 is aligned with the connecting hole of the top cam 824 or the bottom cam 828, as described below. The second connecting hole in connecting hole 1104 can be configured to receive a pin passing through the connecting hole of the top cam 824 or the bottom cam 828. For example, the pin can be a concealed pin, a bolt, etc. The pin can be formed such that a corresponding circular opening is retained and the pin operates as a fulcrum. When the top cam 824 or the bottom cam 828 rotates clockwise or counterclockwise, the combination of the pin and connecting hole 1104 allows the rod 826 to rotate about the pin.

[0178] Figure 5A A side view of the top cam 824 according to an embodiment of this document is shown. Those skilled in the art will recognize that... Figure 5A An example of a cam is shown, and Figure 5A The existing parts shown can be removed and / or additional parts can be added to the top cam 824.

[0179] As shown in the figure, the top cam 824 includes a semicircular ring 1202. The semicircular ring 1202 includes a handle support 1204, a lever connection hole 1206, and a handle connection hole 1208. As described above, the second connection hole in the connection hole 1104 of the lever 826 is aligned with the connection hole 1206 of either the top cam 824 or the bottom cam 828, as described below. The second connection hole in the connection hole 1104 can be configured to receive a pin passing through (either directly or through the connecting member of the handle 802) the connection hole 1206 of either the top cam 824 or the bottom cam 828. For example, the pin can be a concealed pin, bolt, etc. The semicircular ring 1202 is formed such that its width is slightly smaller than the cam groove 910. This allows the top cam 824 to move within the cam groove 910 when force is applied to the handle 802, thereby transmitting force to the semicircular ring 1202 and causing the top cam 824 to rotate clockwise or counterclockwise (depending on the direction of the force applied to the handle 802).

[0180] Figure 5B A side view of the bottom cam 828 according to an embodiment of this document is shown. Those skilled in the art will recognize that... Figure 5B An example of a cam is shown, and Figure 5B The existing parts shown can be removed and / or additional parts can be added to the bottom cam 828.

[0181] As shown in the figure, the bottom cam 828 includes a semicircular ring 1252. The semicircular ring 1252 includes a rod connecting hole 1206 and a cam connecting member 1253 having a connecting hole 1254. As described above, the rod connecting hole 1206 can be configured to receive a pin passing through a second connecting hole in the connecting hole 1104 of the rod 826. The semicircular ring 1252 is formed such that its width is slightly smaller than the cam groove 960. This allows the bottom cam 828 to move within the cam groove 960 when a force is applied to the handle 802 and thus transmitted to the semicircular ring 1252 via the top cam 824.

[0182] The cam connecting member 1253 serves to connect the bottom cam 828 to the top cam 824. The connecting hole 1254 is configured to receive a connecting device for connecting the cam connecting member 1252 to the bottom cam 828. The connecting device can be any type of device for connecting the cam connecting member 1253 to the bottom cam 828, such as a bolt, screw, pin, etc. In some embodiments, the cam connecting member 1253 can be integrated with the bottom cam 828 as a single component.

[0183] Figures 6A to 6C Detailed views of a handle 802 according to an embodiment of this document are shown. Those skilled in the art will recognize that... Figures 6A to 6C An example of a handle is shown, and Figures 6A to 6CThe existing parts shown can be removed and / or additional parts can be added to the handle 802.

[0184] like Figure 6A and Figure 6B (These are perspective and side views, respectively) As shown, the handle 802 includes a handle rod portion 1301 and a handle base portion 1302. The handle base portion 1302 includes a handle rod portion connecting member 1304 and a top cam connecting member 1306. Figure 3C (As shown in another perspective view of the handle 802), the handle rod connecting member 1304 includes a connecting hole for receiving a portion of the handle rod 1301.

[0185] The top cam connecting member 1306 includes a connecting hole 1310 for engaging the handle base 1302 with the top cam 824. The connecting hole 1310 is configured to receive a connecting device for engaging the top cam connecting member 1306 to the top cam 824. The connecting device can be any type of device for engaging the top cam connecting member 1306 to the top cam 824, such as a bolt, screw, pin, etc.

[0186] Figures 8A to 8F An example of a pleater 1500 according to one embodiment of this document is shown. Those skilled in the art will recognize that... Figures 8A to 8F An example of a pleater is shown, and Figures 8A to 8F The existing parts shown can be removed and / or additional parts can be added to the folding press 1500.

[0187] Figure 8A This is a first side view of the first side of the pleater 1500. (See image.) Figure 8A As shown, the folding clip 1500 includes a handle 1502, a folding clip housing 1504, and a base 1506. The folding clip housing 1504 includes, as shown in the figure... Figure 8A The first side 1503 shown and as Figure 8B (This figure is a second side view of the folding device 1500) The second side 1505 is shown opposite to the first side 1503. The first side 1503 of the folding device housing 1504 can be connected to the second side 1505 of the folding device housing 1504 via one or more connectors 1507. The connector 1507 can be any type of device that connects the first side 1503 of the folding device housing 1504 to the second side 1505 of the folding device housing 1504, such as a bolt, screw, pin, etc.

[0188] The folding device housing 1504 includes an opening 1508 extending from a first side 1503 to a second side 1505 of the folding device housing 1504. The opening 1508 may be formed with an approximately circular cross-sectional shape. The opening 1508 provides access to the folding chamber 1516 of the folding device 1500, as described in further detail below.

[0189] Figure 8C and Figure 8D A perspective view and a side view of the folding presser 1500 are shown, with the second side 1505 of the folding presser housing 1504 removed to reveal the internal components of the folding presser 1500. As shown, a handle 1502 extends into the folding presser housing 1504 and includes two cams 1512. The cams 1512 are connected to a plurality of folding elements 1514 via a rod 1518. The folding elements 1514 form a folding chamber 1516.

[0190] Each bar 1518 extends from the two cams 1512 to the middle region of one of the pressing elements 1514, as shown in the reference. Figure 10A and Figure 10B Further details are provided. Each cam 1512 can be formed as an annulus, with a lever 1518 movably connected between the two cams 1512. That is, when the two cams 1512 rotate in response to the movement of the handle 1512, the lever 1518 is allowed to rotate relative to the two cams 1512. Similarly, the lever 1518 is rotatably connected to the pressing element 1514. That is, when the lever 1518 moves in response to the rotation of the two cams 1512, the movement of the lever 1518 is transmitted to the pressing element 1514, thereby causing the pressing element 1514 to move linearly. In embodiments, the construction and components of the pressing element 1514 can be similar to those described above. Figures 3A to 3D Similarly, in embodiments, the construction of the bar 1518 and its components can be similar to those described above. Figure 4 As stated above.

[0191] The two cams 1512 transmit the rotational motion of the handle 1502 to the folding element 1514 via the lever 1518. During operation, the folding element 1514 is displaced by the movement of the handle 1502. That is, as the handle 1502 moves, the two cams 1512 rotate, and the lever 1518 converts the rotational motion of the two cams 1512 into the linear motion of the folding element 1514. Therefore, the folding element 1514 of the folding housing 1504 acts as an iris, allowing the volume of the folding chamber 1516 to decrease or increase via the movement of the handle 1502, as described in further detail below. Figure 8CAs shown, the compression chamber 1516 can define an approximately cylindrical volume. Although the compression chamber 1516 is described above as defining a cylindrical volume, those skilled in the art will recognize that the shape and size of the convex corner can be varied to produce volumes of different shapes depending on the needs of the implantable medical device being compressed and positioned.

[0192] like Figures 8A to 8D As shown in any of the figures, the base 1506 of the crease press 1500 can be formed as a rectangular plate. The base 1506 can be formed such that its width and length extend beyond the length and width of the crease press housing 1504 and the handle 1502. The base 1506 provides a stable platform for operating the crease press 1500 during the crease press procedure. Figure 8C and Figure 8D As shown, the folding housing 1504 is connected to the base 1506 via one or more connectors 1510. The connectors 1510 can be any type of device that connects the folding housing 1504 to the base 1506, such as bolts, screws, pins, etc.

[0193] In this embodiment, the folding device 1500 functions to convert the implantable medical device from its uncompressed state to its compressed state. In operation, the implantable medical device is placed into the folding chamber 1516 and positioned in a direction parallel to the long axis of the base 1506. The delivery device can also be positioned and aligned relative to the implantable medical device. That is, the implantable medical device can be positioned around the delivery device. The actuation handle 1502 converts the implantable medical device from its uncompressed state to its compressed state and mounts the implantable medical device onto the delivery device.

[0194] To operate the pleater 1500, force can be applied to the handle 1502 in the direction of the base 1506. For example... Figure 8E (An enlarged view of the folding mechanism 1500, with the folding mechanism housing 1504 removed) shows that when force is applied, two cams 1512 rotate in the direction in which the force is applied to the handle 1502. Once the two cams 1512 have rotated, the rotational motion of the two cams 1512 is converted into approximately linear motion and transmitted to the folding element 1514 via the lever 1518. Figure 8E As shown, the overlapping portion of the folding element 1514 defines the folding chamber 1516. During operation, for example, the actuation handle 1502 moves downward (e.g. Figure 8E(As shown in the clockwise direction), this causes the cam 1512 to rotate clockwise. Because one end of each lever 1518 is fixed to the cam 1512, and the opposite end is fixed to one of the pressing elements 1514 (allowing rotation), the distance 1512 between the connection between the lever 1518 and the cam and the connection between the lever 1518 and the pressing element 1514 must remain the same when the cam 1512 rotates. However, this same distance can only be maintained when the cam 1512 rotates by pushing the pressing element 1514 inward radially through the lever 1518, as shown in the clockwise direction. Figure 8E and Figure 8F As shown in the comparison, the rotation of cam 1512 thus presses the bending element 1514 inward via lever 1518. Specifically, the bending element 1514 generally moves inward toward the center of the bending chamber 1516. As the bending element 1514 moves inward, the space available for the bending element 1514 to occupy decreases. Therefore, the space between the bending elements 1514 decreases, as referenced above. Figure 3E Further detailed description.

[0195] The folding element 1514 is displaced inward, thereby creating an iris effect. Consequently, the volume of the folding chamber 1516 decreases, and the folding element 1514 applies compressive force to the outer surface of the implantable medical device to fold the expandable medical device from its uncompressed state to its compressed state. For example, if the implantable medical device is circular or cylindrical, when force is applied to the handle 1502, the folding element applies force from multiple different directions on the surface of the implantable medical device, thereby compressing the implantable medical device.

[0196] The folding device 1500 can be used for any type of implantable medical device that requires conversion from an uncompressed state to a compressed state. In embodiments, the folding device can be applied to any implantable medical device that requires on-site folding of the medical device to be implanted onto a catheter, such as organic tissue containing a valve repair device. In embodiments, the folding device 1500 can be used with balloon-expandable medical devices and / or mechanically expandable medical devices.

[0197] For example, the folding device 1500 can be used for implantable medical devices that require transluminal delivery, for example, via a catheter and need to be fitted onto or into a catheter. In this example, the implantable medical device may include a heart valve prosthesis comprising a stent or frame and an artificial valve attached within the frame. The stent / frame can be folded to have a small profile, allowing the prosthesis to be delivered in a compressed state through a blood vessel to a target location, and then (e.g., via a balloon of the delivery device) inflated at the target location to replace the native heart valve. For example, heart valve prostheses are typically fitted onto a delivery device or catheter during implantation surgery (e.g., by a medical professional in a hospital).

[0198] Although the components of the folding press 1500 are described above using the terms “first,” “second,” “proximal,” and “distal,” those skilled in the art will recognize that the use of these terms is intended only to indicate the components of the folding press 1500 and does not limit any preferred or sequential arrangement of the components of the folding press 1500.

[0199] Figure 9A and Figure 9B Detailed views of the components of the second side 1505 of the folding cap housing 1504 are shown. Those skilled in the art will recognize that... Figure 9A and Figure 9B An example of the side of the folding housing 1504 is shown, and Figure 9A and Figure 9B The existing components shown can be removed and / or additional components can be added to the second side 1505. Furthermore, although only the second side 1505 of the folder housing 1504 is described in detail below, those skilled in the art will recognize that the folder housing 1504 includes a first side, which may include components related to… Figure 9A and Figure 9B The same components are shown. For example, the first side 1503 of the folding housing 1504 can be formed as a "mirror image" of the second side 1505 of the folding housing 1504, and can be coupled to the second side 1505 to form the folding housing 1504.

[0200] like Figure 9A (As shown in a perspective view), the second side 1505 of the folding device housing 1504 includes an inner surface 1602 and an outer surface (not shown). In an embodiment, the second side 1505 may be configured as a cylindrical plate having a base portion 1610 formed in an approximately partially rectangular shape. The second side 1505 may include an opening 1508. The cylindrical opening 1508 opens into a folding chamber 1516 formed by the folding element 1514. The second side 1505 also includes a handle opening 1604 formed by a handle stop 1613 extending from the inner surface 1602 of the second side 1505. The handle stop 1613 may extend arcuately around the circumference of the inner surface 1602 of the second side 1505, thereby forming the handle opening 1604. When the handle 1502 is moved, the handle stop 1613 can act as a stop for the handle 1502 in both clockwise and counterclockwise directions.

[0201] A folding element groove 1606 is formed on the inner surface 1602 of the second side 1505. The folding element groove 1606 can be formed as a rectangular groove or slot extending inward from the outer radius of the second side 1505 toward the opening 1508. The folding element groove 1606 can be positioned arc-shaped at equal intervals along the inner surface 1602 of the second side 1505. The folding element groove 1606 is connected to a central cavity 1608 formed on the inner surface 1602 of the second side 1505. The central cavity 1608 can be formed as a circular cavity with a depth approximately the same as that of the folding element groove 1606.

[0202] The folding element groove 1606 and the central cavity 1608 can be configured to movably fix the folding element 1514 within the folding device housing 1504. For example... Figure 9B (As shown in the enlarged perspective view of the folding element groove 1606 and part of the central cavity 1608), the folding element groove 1606 on the second side 1505 is formed with a width and depth such that it accommodates the folding element 1514 when the second side 1505 of the folding housing 1504 mates with the first side 1503 of the folding housing 1504. In an embodiment, the second side 1505 of the folding housing 1504 may be formed with the structure and dimensions as referenced above. Figures 2A to 2C As stated above.

[0203] Figure 10A and Figure 10B Detailed views of a handle 1502 according to an embodiment of this document are shown. Those skilled in the art will recognize that... Figure 10A and Figure 10B An example of a handle is shown, and Figure 10A and Figure 10B The existing parts shown can be removed and / or additional parts can be added to the handle 1502.

[0204] like Figure 10A (As shown in the perspective view of handle 1502), handle 1502 includes a handle rod portion 1702 connected to two cams 1512. In an embodiment, handle rod portion 1702 may be formed as an integral extension of cams 1512. Handle rod portion 1702 may include a spacer member 1703 connecting the sides of handle rod portion 1702. Similarly, the two cams 1512 may be connected by spacer 1704 and pin 1706. Spacer 1704 and pin 1706 serve as connection points for rod 1518. For example, spacer 1704 and pin 1706 may pass through a second connection hole in connection hole 1104 of rod 1518, similar to that described above with reference to rod 826. In some embodiments, pin 1706 may be a concealed pin, bolt, etc. In some embodiments, spacer 1704 may be a hollow cylindrical tube, etc.

[0205] like Figure 10B(As shown in the side view of one of the cams 1512 and the handle lever portion 1702), the handle lever portion 1702 may include a connecting hole 1716. The connecting hole 1716 may be configured to receive a pin that engages the spacer member 1703 between the sides of the handle lever portion 1702. The cam 1512 may also include a connecting hole 1718 for receiving a pin 1706. Furthermore, although references are made below... Figure 10B The case of one cam 1512 has been described in detail, but those skilled in the art will recognize that both cams 1512 may include the same components as shown in FIG10.

[0206] Figures 11A to 11D An example of the operation of a pleater 1500 according to one embodiment of this document is shown. Those skilled in the art will recognize that... Figures 11A to 11D An example of the operation of the pleater 1500 is shown, and Figures 11A to 11D The existing components shown can be removed and / or additional components can be added to the folding device 1500 without departing from the scope of the invention. Furthermore, those skilled in the art will recognize that… Figures 11A to 11D Only a few operating states are shown to illustrate the operation of the folding press 1500, and it will be appreciated that the folding press 1500 can take on other operating states without departing from the scope of the invention.

[0207] like Figure 11A (It is a side view) and Figure 11B (This is a perspective view, in which the second side 1505 is removed.) As shown, the implantable medical device 1802 and the delivery device 1804 can be mounted in the folding chamber 1516 of the folding device housing 1504. For example, the implantable medical device 1802 can be placed in the folding chamber 1516 of the folding device housing 1504. Similarly, the delivery device 1804 can be positioned relative to the implantable medical device 1802.

[0208] like Figure 11B As shown, the folding element 1514 forms a folding chamber 1516. (As indicated...) Figure 11C and Figure 11DAs shown, to compress the medical device 1802, a force is applied to the handle 1102 in the direction of the base 1106. Correspondingly, two cams 1512 rotate clockwise. As the cams 1512 rotate, a force is applied to the folding element 1514 via the rod 1518. Due to the shape of the connecting groove, the folding element 1514 shifts inward; for example, each folding element 1514 slides along the inner slope of an adjacent folding element 1514. Therefore, the inward shift of the folding element 1514 creates an iris effect, thereby reducing the volume of the folding chamber 1516. As the volume of the folding chamber 1516 decreases, the folding element 1514 applies a compressive force to the outer surface of the medical device 1802 to fold it, changing the medical device 1802 from its uncompressed state to its compressed state.

[0209] Figure 12A and Figure 12B Another example of a pleater 1900 according to an embodiment of this document is shown. Those skilled in the art will recognize that... Figure 12A and Figure 12B An example of a pleater is shown, and Figure 12A and Figure 12B The existing parts shown can be removed and / or additional parts can be added to the folding press 1900.

[0210] Figure 12A This is a 3D diagram of the 1900 pleat press. (For example...) Figure 12A As shown, the folding clip 1900 includes a handle 1902, a folding clip housing 1904, and a base 1906. The folding clip housing 1904 includes a first side 1903 and a second side 1905 opposite to the first side 1903. The first side 1903 of the folding clip housing 1904 can be connected to the second side 1905 of the folding clip housing 1904 via one or more connectors 1907. The connector 1907 can be any type of device for connecting the first side 1903 of the folding clip housing 1904 to the second side 1905 of the folding clip housing 1904, such as a bolt, screw, pin, etc.

[0211] The folding device housing 1904 includes an opening 1908 extending from a first side 1903 to a second side 1905 of the folding device housing 1904. The opening 1908 may be formed with an approximately circular cross-sectional shape. The opening 1908 provides access to the folding chamber 1916 of the folding device 1900, as described in further detail below.

[0212] Figure 12BA perspective view of a folding clip 1900 is shown, with the first side 1903 of the folding clip housing 1904 removed to reveal the internal components of the folding clip 1900. As shown, the folding clip 1900 includes a cam 1910. A handle 1902 extends into the folding clip housing 1904 and includes a gear 1912. The gear 1912 engages with the cam 1910 at a gear portion 1913. In other words, the gear 1912 of the handle 1902 includes teeth that mesh with the teeth of the gear portion 1013 of the cam 1910. The folding clip housing 1904 also includes a plurality of folding elements 1914. The cam 1910 is engaged with the plurality of folding elements 1914 via a rod 1918. The folding elements 1914 form a folding chamber 1916.

[0213] Each bar 1918 extends from the cam 1910 to the middle region of one of the pressing elements 1914, as shown in the reference. Figure 15A , Figure 15B and Figures 16A to 16D Further details are provided. The cam 1910 can be formed as a ring, to which the lever 1918 is rotatably coupled. That is, when the cam 1910 rotates in response to the movement of the handle 1912, the lever 1918 is allowed to rotate relative to the cam 1910. Similarly, the lever 1918 is rotatably coupled to the pressing element 1914. That is, when the lever 1918 moves in response to the rotation of the cam 1910, the pressing element 1914 is allowed to rotate relative to the lever 1918. In some embodiments, the construction and components of the pressing element 1914 can be similar to those described above. Figures 3A to 3D In some embodiments, the construction of the bar 1918 and the components it includes may be similar to those described above. Figure 4 As described above. In some embodiments, the construction of the folding element 1914 and the components it includes may be as follows: Figures 16A to 16D Similarly, in some embodiments, the construction of the bar 1918 and the components it includes may be as described below. Figure 15A and Figure 15B As stated above.

[0214] The function of cam 1910 is to transmit the rotational motion of handle 1902 to the pressing element 1914 via lever 1918. In operation, the pressing element 1914 is displaced by the movement of handle 1902. That is, as handle 1902 moves, cam 1910 rotates and converts the rotational motion of handle 1902 into linear motion of pressing element 1914 via lever 1918. Therefore, the pressing element 1914 of the pressing housing 1904 acts as an iris to decrease or increase the volume of pressing chamber 1916 by the movement of handle 1902, as described in further detail below. Figure 12BAs shown, the compression chamber 1916 can define an approximately cylindrical volume. Although the compression chamber 1916 is described above as defining a cylindrical volume, those skilled in the art will recognize that the shape and size of the convex corner can be varied to produce volumes of different shapes depending on the needs of the implantable medical device being compressed and positioned.

[0215] like Figure 12A and Figure 12B As shown, the base 1906 of the folding press 1900 can be formed as a rectangular plate. The base 1906 can be configured such that its width and length extend beyond the length and width of the folding press housing 1904 and the handle 1902. The base 1906 provides a stable platform for operating the folding press 1500 during the folding process. The folding press housing 1904 is connected to the base 1906 via one or more connecting devices 1920. The connecting device 1920 can be any type of device that connects the folding press housing 1904 to the base 1906, such as bolts, screws, pins, etc.

[0216] In this embodiment, the folding device 1900 functions to convert an implantable medical device from its uncompressed state to its compressed state. In operation, the implantable medical device is placed in the folding chamber 1916 and positioned in a direction parallel to the long axis of the base 1906. The delivery device may also be positioned and aligned relative to the implantable medical device. The folding device 1900 is then changed from an open state to a closed state, and the handle 1902 is actuated to convert the implantable medical device from its uncompressed state to its compressed state and to mount the implantable medical device onto the delivery device. To operate the folding device 1900, a force can be applied to the handle 1902 in the direction of the base 1906. When a force is applied, the cam 1910 rotates in the opposite direction to the direction in which the force is applied to the handle 1902. For example, the handle 1902 can be actuated downwards, thereby causing the cam 1912 to rotate clockwise. Accordingly, this causes the cam 1910 to rotate clockwise. Because one end of each lever 1918 is fixed to the cam 1910, and the opposite end is fixed to one of the pressing elements 1914 (allowing rotation), the distance 1910 between the connection between the lever 1918 and the cam and the connection between the lever 1918 and the pressing element 1914 must remain the same when the cam 1910 rotates. However, this same distance can only be maintained when the cam 1910 rotates, as it pushes the pressing element 1914 inward radially via the lever 1918. Therefore, the rotation of the cam 1910 presses the pressing element 1914 inward via the lever 1918. In particular, the pressing element 1914 generally moves inward toward the center of the pressing chamber 1516.

[0217] As the folding elements 1914 move inward, the space available for the folding elements 1914 to occupy decreases. Therefore, the space between the folding elements 1914 decreases. Consequently, the volume of the folding chamber 1916 decreases, and the folding elements 1914 apply compressive force to the outer surface of the implantable medical device to fold the expandable medical device from its uncompressed state to its compressed state. For example, if the implantable medical device is circular or cylindrical, when force is applied to the handle 1902, the folding elements apply force from multiple different directions on the surface of the implantable medical device, thereby compressing the implantable medical device. Reference will be made below. Figures 17A to 17D The operation of the 1900 folding presser will be explained in further detail.

[0218] The folding device 1900 can be used for any type of implantable medical device that requires conversion from an uncompressed state to a compressed state. In embodiments, the folding device can be applied to any implantable medical device that requires on-site folding of the medical device to be implanted onto a catheter, such as organic tissue containing a valve repair device. In embodiments, the folding device 1900 can be used with balloon-expandable medical devices and / or mechanically expandable medical devices. For example, the flap-type folding device 1900 can be used for implantable medical devices that require transluminal delivery, for example, via a catheter and need to be fitted onto or into a catheter. In this example, the implantable medical device may include a heart valve prosthesis comprising a stent or frame and an artificial valve attached within the frame. The stent / frame can be folded to have a small profile, allowing the prosthesis to be delivered in a compressed state through a blood vessel to a target location, and then (e.g., via a balloon of the delivery device) expanded at the target location to replace the native heart valve.

[0219] like Figure 12B As shown, the folding device 1900 also includes a first stop 1950 and a second stop 1952. The first stop 1950 and the second stop 1952 provide surfaces that stop the handle 1902 from moving in the downward direction. The first stop 1950 and the second stop 1952 provide a stop position for the handle 1902 corresponding to a predetermined diameter of the folding chamber 1916. That is, the first stop 1950 and the second stop 1952 serve as physical stops to allow the implanted medical device to be compressed to a predetermined diameter or degree of compression. For example, the first stop 1950 may function to allow the implanted medical device to be partially compressed. Similarly, for example, the second stop 1952 may function to allow the implanted medical device to be fully compressed. The first stop 1950 and the second stop 1952 may be detachably attached to the folding device housing 1904. Therefore, the first top 1950 and / or the second stop 1952 can be added and / or removed to allow the implantable medical device to be compressed to a predetermined diameter.

[0220] Although the components of the folding device 1900 are described above using the terms “first,” “second,” “proximal,” and “distal,” those skilled in the art will recognize that the use of these terms is intended only to indicate the components of the folding device 1900 and does not limit any preferred or sequential arrangement of the components of the folding device 1900.

[0221] Figures 13A to 13D Detailed views of the components of the second side 1905 of the folding cap housing 1904 are shown. Those skilled in the art will recognize that... Figures 13A to 13D An example of the side of the folding case 1904 is shown, and Figures 13A to 13D The existing components shown can be removed and / or additional components can be added to the second side 1905. Furthermore, although only the second side 1905 of the folder housing 1904 is described in detail below, those skilled in the art will recognize that the folder housing 1904 includes a first side, which may include components related to… Figures 13A to 13D The same components are shown. For example, the first side 1903 of the folding housing 1904 can be formed as a "mirror image" of the second side 1905 of the folding housing 1904, and can be connected to the second side 1905 to form the folding housing 1904.

[0222] like Figure 13A (It is a cross-sectional side view) and Figure 13B (As shown in a perspective view), the second side 1905 of the folding device housing 1904 includes an inner surface 2002 and an outer surface (not shown). In an embodiment, the second side 1905 may be configured as a cylindrical plate having a base portion 2010 formed in an approximately partially square shape. The second side 1905 may include an opening 1908. The cylindrical opening 1908 opens into a folding chamber 1916 formed by the folding element 1914. The second side 1905 also includes a handle opening 2004 formed by a handle stop 2013 extending from the inner surface 2002 of the second side 1905. The handle stop 2013 may extend partially around the periphery of the inner surface 2002 of the second side 1905, thereby forming the handle opening 2004. When the handle 1902 is moved, the handle stop 2013 can act as a stop for the handle 1902 in both clockwise and counterclockwise directions. The handle opening 2004 is also configured to receive the first stop 1950 and the second stop 1952.

[0223] A folding element groove 2006 is formed on the inner surface 2002 of the second side 1905. The folding element groove 2006 can be formed as a rectangular groove or slot extending inward from the outer radius of the second side 1905 toward the opening 1908. The folding element groove 2006 can be positioned arc-shaped at equal intervals along the inner surface 2002 of the second side 1905. The folding element groove 2006 is connected to a central cavity 2008 formed on the inner surface 2002 of the second side 1905. The central cavity 2008 can be formed as a circular cavity with a depth approximately the same as that of the folding element groove 2006.

[0224] The folding element groove 2006 and the central cavity 2008 can be configured to movably fix the folding element 1914 within the folding device housing 1904. For example... Figure 13C (As shown in the enlarged perspective view of the folding element groove 2006 and part of the central cavity 2008), the folding element groove 2006 on the second side 1905 is formed with a width and depth such that it accommodates the folding element 1914 when the second side 1905 of the folding housing 1904 mates with the first side 1903 of the folding housing 1904. Figure 13C As shown, the side plate 1902 is formed with a side surface 2082 whose radius extends from the center point 2080 of the opening 1908 to the second side 1905.

[0225] In one embodiment, the radius may be formed to accommodate the length of the folding element 1914 and allow the folding element 1914 to move within the folder housing 1904. In another embodiment, the folding element groove 2006 on the second side 1905 is formed in width and depth such that it accommodates the folding element 1914 when the second side 1905 of the folder housing 1904 mates with the first side of the folder housing 1904. Similarly, the length of the folding element groove 2006 on the second side 1905 and the radius of the central cavity 2008 allow the folding element 1914 to move and perform the folding operation of the folder 1900.

[0226] As described above, the folding element groove 2006 is formed in an arc around the second side 1905. In the embodiment, each folding element groove 2006 is angled with the adjacent folding element groove 2006 in an arc. δ Spacing out. In an embodiment, each pressure-bending element groove 2006 can be aligned by offset angle relative to the radius line of the second side 1905. This offset can cause the pressure element 1914 to move in a direction away from the center point 2080. In some embodiments, the angle It can be in the range of approximately 0 degrees to 30 degrees.

[0227] Figure 14A and Figure 14B A detailed view of the cam 1910 according to an embodiment of this document is shown. Those skilled in the art will recognize that... Figure 14A and Figure 14B An example of a cam is shown, and Figure 14A and Figure 14B The existing parts shown can be removed and / or additional parts can be added to cam 1910.

[0228] like Figure 14A (It is a 3D image) and Figure 14B (As shown in the side view) the cam 1910 includes one or more lever slots 2102. Each lever slot 2102 includes a connecting hole 2106. The connecting hole 2106 is configured to receive a pin that connects the cam 1910 to a connecting hole of the lever 1918. The connecting hole 2106 may be configured to receive a pin passing through the connecting hole of the lever 1918. For example, the pin may be a concealed pin, a bolt, etc. The lever slot 2102 may also be configured to limit the rotational movement of the lever 1918. The cam 1910 also includes a gear 1913 configured to mesh with a gear 1912 of the handle 1902.

[0229] Figure 15A and Figure 15B An example of a rod 1918 is shown. As shown, the rod 1918 is formed as a rectangular rod portion 2202 that connects to two parallel legs 2204. The rectangular rod portion 2202 includes a connecting hole 2206. The rectangular rod portion 2202 may include a circular end 1106 formed in a semi-cylindrical shape. The connecting hole 2206 serves to movably connect a folding element 1914 to the rod 1918. In an embodiment, the connecting hole 2206 is aligned with the connecting hole of the folding element 1914. The connecting hole 2206 can be configured to receive a pin passing through the two connecting holes of the folding element 1914. For example, the pin can be a concealed pin, bolt, etc. The pin can be formed to a diameter such that the corresponding circular opening is retained and the pin operates as a fulcrum.

[0230] In an embodiment, each leg 2204 may include a connecting hole 2208. As described above, the connecting hole 2208 is aligned with the connecting hole 2106 of the cam 1910. The connecting hole 2208 may be configured to receive a pin passing through the connecting hole 2106 of the cam 1910. For example, the pin may be a concealed pin, bolt, etc. The pin may be shaped such that a corresponding circular opening is retained and the pin operates as a fulcrum. When the cam 1910 rotates clockwise or counterclockwise, the combination of the pin and the connecting hole 2208 allows the lever 1918 to rotate about the pin, as restricted by the lever groove 2102.

[0231] Figures 16A to 16D Detailed views of the folding element 1914 according to embodiments herein are shown. Those skilled in the art will recognize that... Figures 16A to 16D An example of a folded element is shown, and Figures 16A to 16DThe existing components shown can be removed and / or additional components can be added to the folding element 1914. Although only one folding element 1914 is described in detail, those skilled in the art will recognize that the construction of any folding element 1914 of the folding device 1900 and the components it includes can be similar to... Figures 16A to 16D The folding element described in the text is the same as that in 1914.

[0232] like Figure 16A (As shown in a perspective view), the folding element 1914 has a first leg 2302, a second leg 2304, and a folding convex angle 2306 connected to the first leg 2302 and the second leg 2304. The first leg 2302 and the second leg 2304 extend parallel to the long axis of the folding element 1914 from the proximal end 2305 of the folding element 1914 to the folding convex angle 2306. The first leg 2302 and the second leg 2304 are spaced apart and define a bar groove 2310. The folding convex angle 2306 extends from the first leg 2302 and the second leg 2304 to the distal end 2307 of the folding element 1914. The folding convex angle 2306 is configured to define a folding space 2308. The folding space 2308 is configured to accommodate an adjacent folding element 1914.

[0233] like Figure 16B (As shown in the side view), the folding element 1914 includes a top surface 2326, a bottom surface 2328, and a distal surface 2330 formed at the ends of the first leg 2302 and the second leg 2304. The folding convex angle 2306 includes a first outer slope 2314 and a second outer slope 2316. The folding convex angle 2306 also includes a first inner slope 2318 and a second inner slope 2320. The intersection of the first leg 2302 and the folding convex angle 2306, and the intersection of the second leg 2304 and the folding convex angle 2306, form a bevel 2322. Figure 16B and Figure 16C (As shown in the bottom view) the first internal ramp 2318, the second internal ramp 2320 and the inclined side 2322 define the compression space 2308.

[0234] like Figure 16D (As shown in the top view), the first outer ramp 2314 and the second outer ramp 2316 form a plane between the top surface 2326 and the distal end 2307 and the bottom surface 2328. The first outer ramp 2314 and the second outer ramp 2316 can be formed at an angle relative to the top surface 2326 and the bottom surface 2328. Similarly, the first inner ramp 2318 and the second inner ramp 2320 can be formed at an angle relative to the top surface 2326 and the bottom surface 2328. The intersection of the first leg 2302 and the bending convex angle 2306 and the second leg 2304 and the bending convex angle 2306 form a hypotenuse 2322.

[0235] The size of the folding element 1914 can be determined by the size of the object being folded. In embodiments, the width of the folding element 1914 can range from approximately 25 mm to approximately 50 mm, and the length of the folding element 1914 can range from approximately 1 mm to approximately 40 mm. The slopes (angles relative to the top surface 2326 and bottom surface 2328) of the first outer ramp 2314 and the second outer ramp 2316 can depend on the folding elements included in the flap-type folder 1900. Similarly, the slopes (angles relative to the top surface 2326 and bottom surface 2328) of the first inner ramp 2318, the second inner ramp 2320, and the inclined edge 2322 can depend on the folding elements included in the flap-type folder 1900. In embodiments, the slope can be determined by dividing 360 degrees by the number of folding elements 1914 in the flap-type folder 1900. In embodiments, the number of folding elements can range from 10 to 12. The first internal ramp 2318, the second internal ramp 2320, and the inclined side 2322 are configured to contact the adjacent folding element and produce an iris effect when the folding element is displaced.

[0236] The folding element 1914 also includes connecting holes 2312. Connecting holes 2312 are formed in the first leg 2302 and the second leg 2304. In an embodiment, the folding element 1914 may include two connecting holes 12312 positioned opposite each other on the first leg 2302 and the second leg 2304. In an embodiment, the connecting holes 1912 may be configured to receive a pin passing through the connecting holes of the two connecting holes and the rod 1926. For example, the pin may be a concealed pin, bolt, etc. The pin may be shaped such that a corresponding circular opening is retained and the pin operates as a fulcrum. The connecting holes 2312 serve to movably connect the folding element 1914 to the rod 1918. The rod 1918 is engaged within a rod groove 2310. The rod groove 2310 allows the rod 1918 to rotate relative to the folding element 1914 during operation of the flap-type folding device 1900.

[0237] In an embodiment, the folding element 1914 may include two inclined shoulders 2350 formed on the outer surfaces of the first leg 2302 and the second leg 2304, respectively. The inclined shoulders 2350 may serve to retain the first leg 2302 and the second leg 2304 within one of the slots 2006. That is, the inclined shoulders 2350 extend from the first leg 2302 and the second leg 2304 along the width of the folding element 1914, thereby engaging a slot or the slot 2006. In an embodiment, the width of the outer ramp 2314 may be specific to the size of the implanted medical device being folded. Therefore, the size of the outer shoulders 2350 may vary based on the size of the implanted medical device being folded.

[0238] In an embodiment, the dimensions of the compression element 1914, which has a 30 mm construction, can be similar to those described above. Figures 3F to 3H The dimensions are described. Table 2 below describes them as follows: Figures 3F to 3H The dimensions are defined and exemplary dimensional values ​​for the folding element 1914 are provided. Those skilled in the art will recognize that the dimensional values ​​are examples and that the folding element 1914 may have different dimensional values ​​based on the specific construction of the folder 1900 and the folding application.

[0239] Table 2

[0240]

[0241] Figure 17A Figure 17E shows a detailed view of the handle 1902 according to an embodiment of this document. Those skilled in the art will recognize that... Figure 17A Figure 17E shows an example of a handle, and Figure 17A The existing parts shown in Figure 17E can be removed and / or additional parts can be added to the handle 1902.

[0242] like Figure 17A and Figure 17B (As shown in the perspective and side view, respectively), the handle 1902 includes a handle rod portion 2402 and a cam 1912. The handle rod portion 2402 includes a handle rod end portion 2406. The cam 1912 may include a tooth 2408 and a connecting member 2412. The connecting member 2412 may be formed as a protrusion configured to engage a connecting groove 2054, which is formed by a circular ridge 2052 within a cam groove 2050 of the folding housing 1904. The tooth 2408 is configured to engage the tooth of the cam 1910.

[0243] like Figure 17A and Figure 17B As shown, the handle 2402 may include a curved or bent portion 2420. When the user operates the handle 1902, the curved or bent portion 2420 provides a lever effect. Figure 17C and Figure 17D As shown, the curved or bent portion 2420 can be removed from the handle rod portion 2402.

[0244] Figures 18A to 18D An example of the operation of a pleater 1900 according to one embodiment of this document is shown. Those skilled in the art will recognize that... Figures 18A to 18D An example of the operation of the 1900 pleater is shown, and Figures 18A to 18D The existing components shown can be removed and / or additional components can be added to the folding device 1900 without departing from the scope of the invention. Furthermore, those skilled in the art will recognize that… Figures 18A to 18DOnly a few operating states are shown to illustrate the operation of the folding device 1900, and it will be appreciated that the folding device 1900 can take on other operating states without departing from the scope of the invention.

[0245] like Figure 18A (It is a side view) and Figure 18B (This is a perspective view, in which the first side 1903 is removed.) As shown, the implantable medical device 2502 and the delivery device 2504 can be fitted into the folding chamber 1916 of the folding device housing 1904. For example, the implantable medical device 2502 can be placed in the folding chamber 1916 of the folding device housing 1904. Similarly, the delivery device 2504 can be positioned relative to the implantable medical device 2502.

[0246] like Figure 18B As shown, the folding element 1914 forms the folding chamber 1916. (As...) Figures 18C to 18E As shown, to compress the medical device 2502 and operate the folding device 1900, a force can be applied to the handle 1902 in the direction of the base 1906. When a force is applied, the cam 1910 rotates in the opposite direction to the direction in which the force is applied to the handle 1902. For example, the handle 1902 can be actuated downwards, thereby causing the cam 1912 to rotate clockwise. Accordingly, this causes the cam 1910 to rotate clockwise. Because one end of each lever 1918 is fixed to the cam 1910, and the opposite end is fixed to one of the folding elements 1914 (allowing rotation), the distance 1910 between the connection between the lever 1918 and the cam and the connection between the lever 1918 and the folding element 1914 must remain the same when the cam 1910 rotates. However, this same distance can only be maintained when the cam 1910 rotates, provided that the folding element 1914 is pushed inwards radially by the lever 1918. Therefore, the rotation of cam 1910 presses the folding element 1914 inward via lever 1918. In particular, the folding element 1914 generally moves inward toward the center of the folding chamber 1516.

[0247] As the folding elements 1914 move inward, the space available for the folding elements 1914 decreases. Therefore, the space between the folding elements 1914 decreases. Consequently, the volume of the folding chamber 1916 decreases, and the folding elements 1914 apply compressive force to the outer surface of the implantable medical device to fold the expandable medical device from its uncompressed state to its compressed state. For example, if the implantable medical device is circular or cylindrical, when force is applied to the handle 1902, the folding elements apply force from multiple different directions on the surface of the implantable medical device, thereby compressing the implantable medical device.

[0248] like Figure 18CAs shown, the handle 1902 can be moved downwards until it abuts against the first stop 1950, thereby partially compressing the implantable medical device 2502 to a predetermined diameter. If only partial compression of the implantable medical device 2502 is required, the handle 1902 can be moved upwards and the implantable medical device 2502 can be removed. Figure 18D and Figure 18E As shown, in the case of implantable medical device 2502, stop 1950 can be removed, and handle 1902 can be moved further downward until handle 1902 abuts against second stop 1952. Further movement of handle 1902 results in additional compression of implantable medical device 2502.

[0249] Figures 19A to 19G Another example of a flap-type folding device 2600 according to one embodiment of this document is shown. Those skilled in the art will recognize that... Figures 19A to 19G An example of a pleater is shown, and Figures 19A to 19G The existing parts shown can be removed and / or additional parts can be added to the flap folder 2600.

[0250] Figure 19A This is a side view of the first side 2601 of the flip-top folding mechanism 2600. (See attached image.) Figure 19A As shown, the flip-top folding device 2600 includes a handle 2602, a top housing 2604 (or a top iris housing), and a base housing 2606 (or a base iris housing). The top housing 2604 includes a first outer shell 2610, while the base housing 2606 includes a first outer shell 2612. The top housing 2604 and the base housing 2606 are connected at a pivot connection 2608. The pivot connection 2608 allows the top housing 2604 to rotate about an axis R ( ) of rotation of the pivot connection 2608. Figure 19C (As shown) Rotate away from the base housing to make the angle between the top housing 2604 and the base housing 2606... θ Increase or decrease. The pivot connection 2608 is configured to allow the top housing 2604 and the base housing 2606 to move relative to each other from an open state (e.g., Figures 19A to 19C (as shown) becomes the off state (e.g.) Figure 19F As shown). Figure 19G (As shown in the perspective view), the flap-type folding device 2600 may include a first side 2601 and a second side 2603 connected to the first side 2601. In an embodiment, the second side 2603 may include components of the first side 2601, as disclosed in further detail below. The flap-type folding device 2600 may be connected to a base 2607 or other structure to provide support for the flap-type folding device 2600.

[0251] As described above, the open state of the flap-type folding device 2600 defines any angle between the top housing 2604 and the base housing 2606. θ This angle allows the user to insert the implantable medical device and / or delivery device into the flap-type folder 2600 and allows the user to view the insertion to ensure proper alignment of the implantable medical device and delivery device. Similarly, as described above, the closed state defines either angle between the top housing 2604 and the base housing 2606. θ Within this angle, the operation of the flip-type folding device 2600 compresses and folds the implantable medical device or mounts it onto the delivery device. For example, in an embodiment, when in the open state, the angle between the top housing 2604 and the base housing 2606... θ It can be in the range of approximately 45 degrees to approximately 180 degrees. Similarly, for example, in an embodiment, the angle between the top housing 2604 and the base housing 2606 when in the closed state... θ It can be approximately 0 degrees Celsius.

[0252] Figure 19B A different view of the first side 2601, opposite to the first side, is shown of the flap-type folding mechanism 2600. Figure 19B In the view, the outer casing of the second side 2603 of the flap-type folding mechanism 2600 is removed to reveal the internal components of the flap-type folding mechanism 2600. As shown, the top casing 2604 includes a first outer casing 2610 and a second outer casing (removed in this figure). The base casing 2606 includes a first outer casing 2612 and a second outer casing (removed in this figure). The top casing 2604 and the base casing 2606 include a plurality of folding elements 2614. Figure 19C (This is an enlarged perspective view of the top housing 2604 and the base housing 2606.) Further, the pressure-bending element 2614 of the top housing 2604 forms a top pressure-bending groove 2616. The pressure-bending element 2614 of the base housing 2606 forms a bottom pressure-bending groove 2618. When in the closed state, the top pressure-bending groove 2616 and the bottom pressure-bending groove 2618 form a pressure-bending chamber 2619, as shown... Figure 19F (It is shown as a perspective view of the flip-top folding mechanism 2600 in the closed state.)

[0253] In embodiments, the pivot connection 2608 can be any type of mechanical or electromechanical connection that allows the top housing 2604 and the base housing 2606 to move relative to each other. For example, the pivot connection 2608 may include one or more of hinges, buckles, rivets, pivot pins, pivot couplings, shafts, movable hinges, etc. In embodiments, the pivot connection 2608 may include motion-assisting devices to provide forces that assist the movement of the top housing 2604 and the base housing 2606 relative to each other. For example, the pivot connection 2608 may include springs, motors, etc.

[0254] like Figure 19D and Figure 19E (As shown in the exploded view of the internal components of the folding element 2600), the first outer housing 2610 (which has been removed) of the top housing 2604 may include a top folding element housing 2620 and a top cam 2622. The handle 2602 is engaged with the top cam 2622, as described below. Figure 19E Further described. The first outer housing 2610 of the base housing 2606 may include a base folding element housing 2624 and a base cam 2626. The top folding element housing 2620 and the base folding element housing 2624 may be configured to movably retain the folding element 2614 within folding element slots 2630 of the top folding element housing 2620 and the base folding element housing 2624, as described below. Figure 20A and Figure 20B Further details are provided. In an embodiment, the second side 2603 may include a top cam, a bottom cam, and a handle, which is connected to the handle 2602 via a handle rod 2605, as shown below. Figure 19G As shown.

[0255] In an embodiment, each pressure-bending element 2614 may include a pin 2680. For example... Figure 19D and Figure 19E As shown, each pressing element 2614 may include two pins 2680 formed on opposite sides of each pressing element 2614. The top cam 2622 and the base cam 2626 can be connected to the pressing element 2614 via the pins 2680. That is, the top cam 2622 and the base cam 2626 include a plurality of pin slots 2670, such as... Figure 19D As shown. Similarly, the top and bottom cams of the second side 2603 can be connected to the pressing element 2614 via pins 2608 positioned on opposite surfaces of the pressing element 2614. Each pin 2680 extends from a central region of the pressing element 2614 to a pin groove 2670 of the top cam 2622 or the base cam 2626, as shown below. Figures 21A to 21GThe top cam 2624 functions to transmit the rotational movement of the handle 2602 to the folding element 2614 via a pin movably connected to it in pin 2680. The base cam 2626 functions to transmit the movement of the handle 2602 (via the movement of the top cam 2622) to the folding element 2614 via a pin connected to it in pin 2680. When in the closed state, the base cam 2626 is engaged with the top cam 2622, causing the top cam 2622 and the base cam 2626 to rotate together and function as a single cam. That is, when engaged, the top cam 2622 and the base cam 2626 form a cylindrical ring inside the flap-type folding device 2600. An example of the top cam 2622 and the base cam 2626 will be referenced. Figure 22 A and Figure 22 B is described in further detail below.

[0256] like Figure 19E As shown, the top cam 2622 is configured to be movably held within a top cam groove 2632 formed in the top folding element housing 2620. Similarly, the base cam 2626 is configured to be movably held within a base cam groove 2634 formed in the base folding element housing 2624. The top cam groove 2632 may be a semi-circular groove formed around the outer surface 2636 of the top folding element housing 2620. The base cam groove 2634 may be a semi-circular groove formed around the outer surface 2638 of the base folding element housing 2624. When the flip-top folding device 2600 is in the closed state, the top cam groove 2632 and the base cam groove 2634 may form a circular groove that receives the top cam protrusion 2640 of the top cam 2622 and the base cam protrusion 2642 of the base cam 2624. The top cam buckle 2640 and the base cam buckle 2642 can be configured to move within the top cam groove 2632 and the base cam groove 2634 to allow the top cam 2622 and the base cam 2626 to rotate relative to the top folding element housing 2620 and the base folding element housing 2624, as described in further detail below.

[0257] In some embodiments, such as Figure 19D As shown, the top folding element housing 2620 of the top housing 2604 may include a protrusion 2650 extending from the rear portion of the top folding element housing 2620. The protrusion 2650 includes a pivot connection hole 2652. As... Figure 19EAs shown, the base folding element housing 2624 of the base housing 2606 may include a protrusion 2654 extending from the rear portion of the base folding element housing 2624. The protrusion 2654 includes a pivot connection hole 2626. When the protrusions 2650 and 2654 mate, the pivot connection holes 2652 and 2656 can form concentric holes that serve as a pivot connection portion 2608 when a pin, rivet, bolt, screw, or other connecting mechanism is inserted into the concentric holes. For example, the pivot connection portion 2608 may include a pin positioned in a corresponding concentric hole formed by the pivot connection hole 2652 of the top folding element housing 2656 and the pivot connection hole 2656 in the base folding element housing 2624. For example, the pin may be a concealed pin, bolt, etc. The pin may be shaped to a diameter such that a corresponding circular opening is retained, allowing the pin to operate as a fulcrum.

[0258] In one embodiment, the top housing 2604 and the base housing 2606 may be separate components that can be detachably attached at the pivot connection 2608 to form the flap-type folder 2600. In another embodiment, the top housing 2604 and the base housing 2606 may be single components, for example, folded toward each other via a movable hinge between them to form the integrated flap-type folder 2600. The top housing 2604 and the base housing 2606 may be formed of any suitable material, such as, but not limited to, aluminum, stainless steel, or polymeric materials. Although the flap-type folder 2600 is described as pivoting at the pivot connection 2608, those skilled in the art will appreciate that the top housing 2604 and the base housing 2606 may move relative to each other using other types of process and mechanical connections.

[0259] like Figure 19C and Figure 19D As shown, the folding elements 2614 are arranged to partially overlap between the top housing 2604 and the base housing 2606 in a first direction. In an embodiment, the folding elements 2614 of the top housing 2604 are arranged to partially overlap to form a top folding groove 2616 at the distal end of the folder (e.g., see reference). Figures 21A to 21G (Described as follows). The folding element 2614 of the base housing 2606 is arranged to partially overlap, forming a bottom folding groove 2618 at the distal end of the folding element 2616. When the flip-top folding device 2600 is in the closed state, the top folding groove 2616 and the bottom folding groove 2618 define a folding chamber 2619. That is, when in the closed state, the folding elements 2614 of the top housing 2604 and the folding elements 2614 of the base housing 2606 form a cylinder at the overlapping end of the folding element 2614, having a cylindrical cavity through the center, thereby defining the folding chamber 2619.

[0260] In an embodiment, the flip-top folding device 2600 can operate similarly to the flip-top folding device 800, as described above. That is, when in the closed state, the folding element 2614 is displaced by the movement of the handle 2602. When force is applied, the top cam 2622 and the base cam 2626 rotate in the direction in which force is applied to the handle 2602. In an embodiment, pin slots 2670 are formed in a helical pattern on the top cam 2622 and the base cam 2626. That is, each pin slot 2670 is formed as an arc shape in which the distance from each pin slot 2670 to the folding chamber 2619 decreases along a first direction. During the rotation of the handle 2602, the folding element 2614 is movably held within the folding element groove 2630 of the top folding element housing 2620 and the base folding element housing 2624. The folding element groove 2630 allows the folding element 2614 to move inward toward the folding chamber 2619.

[0261] When the handle 2602 moves, the rotation of the top cam 2622 and the base cam 2626 applies a force to the pin 2680, thereby causing the pin 2680 to shift inward as it travels within the pin groove 2670, which gradually decreases in distance from the folding chamber 2619. This inward movement of the pin 2680 causes the folding element 2614 of the top housing 2604 and the base housing 2606 to shift inward within the folding element groove 2630, thereby producing an iris effect. That is, the inward movement of the pin 2680 is transmitted to the folding element 2614, causing the folding element 2614 to shift inward, as described in further detail below. Therefore, the volume of the folding chamber 2619 decreases, and the folding element 2614 applies a compressive force to the outer surface of the implantable medical device to fold the expandable medical device from its uncompressed state to its compressed state.

[0262] For example, if the implantable medical device is circular or cylindrical, when force is applied to the handle 2602, the folding element 2614 applies force from multiple different directions on the surface of the implantable medical device, thereby compressing the implantable medical device. That is, when in the closed state, the folding element 2614 is displaced by the movement of the handle 2602. As the handle 2602 moves, the top cam 2622 and the base cam 2626 rotate and convert the rotational movement of the handle 2602 into linear movement of the folding element 2614 via the pin 2680. Therefore, the folding elements 2614 of the top housing 2604 and the base housing 2606 act as irises, decreasing or increasing the volume of the folding chamber 2619 by the movement of the handle 2602. In operation, the implantable medical device is inserted into the bottom folding groove 2618 and positioned in a direction parallel to the rotation axis R of the top housing 2604 and the base housing 2606. The delivery device can also be positioned and aligned relative to the implantable medical device. That is, the implantable medical device can be positioned around the delivery device. Therefore, the volume of the folding chamber 2619 is reduced, and the folding element 2614 applies compressive force to the outer surface of the implantable medical device to fold the expandable medical device from its uncompressed state to its compressed state. For example, if the implantable medical device is circular or cylindrical, when force is applied to the handle 2602, the folding element 2614 applies force from multiple different directions on the surface of the implantable medical device, thereby compressing the implantable medical device.

[0263] like Figure 19F As shown, when in the closed state, the fold chamber 2619 can define an approximately cylindrical volume. While the fold chamber 2619 is described above as defining a cylindrical volume, those skilled in the art will recognize that the shape and size of the fold element 2614 can be varied to produce volumes of different shapes depending on the needs of the implantable medical device being compressed and positioned. The flip-top folder 2600 is configured to receive the implantable medical device and change it from an uncompressed state to a compressed state via the fold element 2614, resulting in a reduction in the volume of the fold chamber 2619. Furthermore, the flip-top folder 2600 is configured to fold or mount the implantable medical device onto a delivery device. In embodiments, the fold element 2614 may be removable from the top housing 2604 and / or the base housing 2606. Therefore, the fold element 2614 can be interchanged with other types of fold elements configured to adapt to different sizes and / or configurations of implantable medical devices and / or delivery devices. The folding element 2614 can be formed from any suitable material, such as, but not limited to, aluminum, stainless steel or polymer materials.

[0264] The flip-top folding device 2600 can be used for any type of implantable medical device that requires conversion from an uncompressed state to a compressed state. In embodiments, the folding device can be applied to any implantable medical device that requires on-site folding of the medical device to be implanted onto a catheter, such as organic tissue containing a valve repair device. In embodiments, the folding device 2600 can be used with balloon-expandable medical devices and / or mechanically expandable medical devices. For example, the flip-top folding device 2600 can be used for implantable medical devices that require transluminal delivery, for example, via a catheter and need to be fitted onto or into a catheter. In this example, the implantable medical device may include a heart valve prosthesis comprising a stent or frame and an artificial valve attached within the frame. The stent / frame can be folded to have a small profile, allowing the prosthesis to be delivered in a compressed state through a blood vessel to a target location, and then (e.g., via a balloon of the delivery device) expanded at the target location to replace the native heart valve.

[0265] By opening the flip-top folding device 2600 to a sufficiently large angle to view the bottom folding groove 2618, the user can correctly position and locate the heart valve prosthesis relative to the catheter. For example, when a balloon catheter (a non-folded stent / frame with the heart valve prosthesis) is placed within the flip-top folding device 2600, the user can visually ensure that the prosthesis is correctly positioned above the balloon of the catheter before continuing the folding operation. The open top insertion design of the flip-top folding device 2600 provides greater visibility for the insertion and alignment of implantable medical devices and delivery devices, as well as for rapid fine-tuning. That is, because the implantable medical device and delivery device are easily accessible by opening the flip-top folding device 2600, the relative alignment of the implantable medical device and delivery device can be monitored and adjusted without removing them from the flip-top folding device 2600. For example, heart valve prostheses are typically inserted onto the delivery device or catheter during implantation surgery (e.g., by medical personnel in a hospital). Proper alignment and placement of the prosthesis onto the delivery catheter are crucial; errors can lead to the discarding of misaligned prostheses, which is both wasteful and costly. The 2600 flip-top folding device provides a simple and accurate procedure for folding such heart valve prostheses onto balloon catheters in a hospital setting. Furthermore, the 2600 flip-top folding device eliminates the complex geometry and machining typically required for iris folding devices.

[0266] return Figure 19D and Figure 19EThe handle 2602 can be formed as a separate component attached to the top cam 2622. In other embodiments, the handle 2602 can be integrated with the top cam 2622 as a single-piece handle. In embodiments, the shape, size, design, and / or construction of the handle 2602 can be adapted to different folding operations. For example, the handle 2602 can extend and include a pivot point for increasing leverage during the folding operation. Similarly, the handle 2602 can include one or more attachments that facilitate pulling the handle 2602 downward, such as a handle extension that can be operated by the user's foot. The handle 2602 can be formed of any suitable material, such as, but not limited to, aluminum, stainless steel, or polymeric materials.

[0267] In one embodiment, the top housing 2604 may include a handle locking mechanism that locks the handle 2602 in the open position (e.g., the folding chamber 2619 is opened to its maximum diameter). The top housing 2604 and / or the base housing 2606 may include a housing locking mechanism that locks the top housing 2604 and the base housing 2606 together in a closed state (e.g., the top housing 2604 and the base housing 2606 are together). When the handle 2602 is locked by the handle locking mechanism, the flap-type folding device 2600 can be opened by pivoting the top housing 2604 away from the base housing 2606 (e.g., the top folding groove 816 and the bottom folding groove 2618 are separated). During the folding operation, the top housing 2604 can be closed, for example, using handle 2602, and the top housing 2604 and base housing 2606 can be locked in a closed state, for example, with the top housing 2604 and base housing 2606 together. The handle 802 can then be unlocked to perform the folding operation by releasing the handle locking mechanism. The double locking prevents the top folding groove 2616 of the top housing 2604 or the bottom folding groove 2618 of the base housing 2606 from moving to the closed position while the other half remains in the open position.

[0268] In embodiments, the flip-type folding device 2600 may further include one or more stops, such as stop 2609, which physically stops the folding device handle 2602 (and the folding device handle on the second side 2603) at one or more predetermined positions corresponding to one or more predetermined diameters to which the implantable medical device can be folded or compressed. Although not shown, in some embodiments, the flip-type folding device 2600 may include a first stop and a second stop. The first and second stops provide surfaces that stop the handle 2602 from moving in a downward direction. The first and second stops provide a stopping position for the handle 2602 corresponding to a predetermined diameter of the folding chamber 2619. That is, the first and second stops serve as physical stops that allow the implantable medical device to be compressed to a predetermined diameter or degree of compression. For example, the first stop may allow the implantable medical device to be partially compressed. Similarly, for example, the second stop may allow the implantable medical device to be fully compressed. The first and second stops can be detachably attached to the top housing 2604, base housing 2606, and / or base of the flip-top compression device 2600. Therefore, the first top and / or second stops can be added and / or removed to allow the implantable medical device to be compressed to a predetermined diameter.

[0269] Although the components of the flip-type folding device 2600 are described above using the terms “first,” “second,” “proximal,” and “distal,” those skilled in the art will recognize that the use of these terms is intended only to indicate the components of the flip-type folding device 2600 and does not limit any preferred or sequential arrangement of the components of the flip-type folding device 2600. Similarly, for example, although the implantable medical device is described as being positioned in the bottom folding groove 2618 during operation, in embodiments, the implantable medical device may be positioned in the top folding groove 2616.

[0270] Figure 20A Detailed views of the components of the top folding element housing 2620 of the top housing 2604 are shown. Those skilled in the art will recognize that... Figure 20A An example of the component housing of the top housing 2604 is shown, and Figure 20A The existing components shown can be removed and / or additional components can be added to the top folding element housing 2620. Furthermore, although only the top folding element housing 2620 is described in detail below, those skilled in the art will recognize that in some embodiments, the top housing 2604 includes a second housing that can include components similar to... Figure 20AThe same components are shown. For example, the second housing may be formed as a “mirror image” of the top folding element housing 2620 and may be coupled to the top folding element housing 2620 to form the top housing 2604. Alternatively, in some embodiments, the second side of the top housing 2604 may include a pin groove mirroring the pin groove 2670 of the top cam 2622.

[0271] like Figure 20A As shown, the top folding element housing 2620 includes a side plate 2702 having an inner surface 2703 and an outer surface (not shown) opposite to the inner surface. In an embodiment, the side plate 2702 may be configured as a semi-cylindrical plate with a semi-cylindrical opening 2708. The semi-cylindrical opening 2708 opens into a top folding groove 2616 formed by the folding element 2614. A folding element groove 2630 is formed on the inner surface 2703 of the side plate 2702. The folding element groove 2630 may be formed as a rectangular recess or slot extending inward from the outer radius of the side plate 2702 toward the semi-cylindrical opening 2708. The folding element groove 2630 may be equidistantly positioned along an arcuate arc along the inner surface 2703 of the side plate 2702. The folding element groove 2654 is coupled to a central cavity 2706 formed on the inner surface 2703 of the side plate 2702. The central cavity 2706 can be formed as a semi-circular cavity with a depth approximately the same as that of the pressure-bending element groove 2630.

[0272] Each pressure-bending element slot 2630 includes a pin slot 2720. The pin slot 2720 is configured to allow the pin 2680 of the pressure-bending element 2614 to pass through the side plate 2702 and engage with the top cam 2622. The side plate 2702 also includes a cam groove 2632 formed within the outer surface of the side plate 2702. The cam groove 2632 extends in a semi-circular arc from the bottom surface 2711 of the side plate 2702. The cam groove 2632 may be configured to receive and retain the top cam 2622 via a snap 2640, and is configured to allow the top cam 2622 to move (e.g., rotate) within the top housing 2604.

[0273] Figure 20B Detailed views of the components of the base housing 2606 and the base bending element housing 2624 are shown. Those skilled in the art will recognize that... Figure 20B An example of the housing of the base housing 2606 is shown, and Figure 20B The existing components shown can be removed and / or additional components can be added to the base folding element housing 2624. Furthermore, although only the base folding element housing 2624 is described in detail below, those skilled in the art will recognize that the base housing 2506 includes a second housing that can include components similar to... Figure 20BThe same components are shown. For example, the second housing may be formed as a "mirror image" of the base folding element housing 2624 and may be coupled to the base folding element housing 2624 to form the base housing 2606. Alternatively, in some embodiments, the second side of the base housing 2506 may include a pin groove mirroring the pin groove 2670 of the top cam 2626.

[0274] like Figure 20B As shown, the base folding element housing 2624 includes a side plate 2752 having an inner surface 2753 and an outer surface (not shown). In an embodiment, the side plate 2752 may be configured as a semi-cylindrical plate with a semi-cylindrical opening 2758. The semi-cylindrical opening 2758 opens into a bottom folding groove 2618 formed by the folding element 2614. A folding element groove 2630 is formed on the inner surface 2753 of the side plate 2752. The folding element groove 2630 may be formed as a rectangular recess or slot extending inward from the outer radius of the side plate 2752 toward the semi-cylindrical opening 2758. The folding element groove 2630 may be equidistantly positioned along an arcuate path along the inner surface 2753 of the side plate 2752. The folding element groove 2654 is coupled to a central cavity 2756 formed on the inner surface 2753 of the side plate 2752. The central cavity 2756 can be formed as a semi-circular cavity with a depth approximately the same as that of the pressure-bending element groove 2630.

[0275] Each pressure-bending element slot 2630 includes a pin slot 2770. The pin slot 2770 is configured to allow the pin 2680 of the pressure-bending element 2614 to pass through the side plate 2752 and engage with the base cam 2626. The side plate 2752 also includes a cam groove 2632 formed within the outer surface of the side plate 2752. The cam groove 2632 can extend in a semi-circular arc from the top surface 2761 of the side plate 2752. The cam groove 2632 can be configured to receive and retain the base cam 2626 via a snap 2642, and is configured to allow the base cam 2626 to move (e.g., rotate) within the base housing 2606.

[0276] The folding element groove 2630 and the central cavity 2706 can be configured to movably fix the folding element 2614 within the top housing 2604. Similarly, the folding element groove 2630 and the central cavity 2756 can be configured to movably fix the folding element 2614 within the base housing 2606. Figure 20C An enlarged perspective view of the pressure-bending element groove 2630 and a portion of the central cavity 2706 according to an embodiment of this document is shown. (Although referenced...) Figure 20C The construction and dimensions of the side plate 2702 of the top housing 2604 are described, but those skilled in the art will recognize that... Figure 20C The construction described herein can also be applied to the construction of the side plate 2752 of the base housing 2606.

[0277] like Figure 20C As shown, the side plate 2702 is formed such that its radius extends from the center point 2780 of the semi-cylindrical opening 2708 to the side surface 2782 of the side plate 2702. In an embodiment, the radius line may be formed such that its length adapts to the folding element 2614 and allows the folding element to move within the top housing 2604. In an embodiment, the folding element groove 2630 of the side plate 2702 is formed such that its width and depth accommodate the folding element 2614 when the side plate 2602 is in place. Similarly, the length of the folding element groove 2630 formed by the side plate 2702 and the radius formed by the central cavity 2706 allow the folding element 2614 to move and perform the folding operation of the flap-type folder 2600. The pin groove 2720 may have a groove length.

[0278] As described above, the folding element groove 2630 is formed around the side plate 2702 in an arc shape. In the embodiment, each folding element groove 2630 is angled to the adjacent folding element groove 2630 in an arc shape. δ Spacing out. For example, the pressure-bending element slots 2630 can be spaced apart at an angle of approximately 30 degrees. δ In this embodiment, each pressure-bending element slot 2630 can be aligned by offsetting an angle relative to the radius line of the side plate 2702. For example, such as Figure 20C As shown, when measured at the intersection 2786 of the radius line and the side wall 2784 of the pressure element groove 2630, the angle This can be defined as the angle between the radius line and the sidewall 2784. This offset can cause the folding element 2614 to move in a direction away from the center point 2780. For example, the folding element groove 2630 can be offset by an angle of approximately 15 degrees. .

[0279] Figures 21A to 21H Detailed views of the folding element 2614 according to embodiments herein are shown. Those skilled in the art will recognize that... Figures 21A to 21H An example of a folding element is shown, and Figures 21A to 21H The existing components shown can be removed and / or additional components can be added to the folding element 2614. Although only one folding element 2614 is described in detail, those skilled in the art will recognize that the construction of the folding element 2614 of the top housing 2604 and the base housing 2606, and the components it includes, can be different from those of other folding elements. Figures 21A to 21H The pressure-bending element 2614 described herein is the same.

[0280] like Figure 21A(As shown in a perspective view), the folding element 2614 has a body 2802 and a folding protrusion 2806 connected to the body 2802. The body 2802 extends from the proximal end 2805 of the folding element 2614 to the folding protrusion 2806, parallel to the long axis of the folding element 2614. The folding protrusion 2806 extends from the body 2802 to the distal end 2807 of the folding element 2614.

[0281] like Figure 21B (As shown in the side view), the folding element 2614 includes a top surface 2826, a bottom surface 2828, and a distal surface 2830 formed at the end of the body 2802. The folding convex angle 2806 includes a first outer slope 2814 and a second outer slope 2816. The folding convex angle 2806 also includes a first inner slope 2818 and a second inner slope 2820. The intersection of the body 2802 and the folding convex angle 2806 forms a bevel 2822. Figure 21B and Figure 21C (As shown in the bottom view) the first internal ramp 2818, the second internal ramp 2820 and the inclined side 2822 define the compression space 2808.

[0282] like Figure 21D (As shown in the top view), the first outer ramp 2814 and the second outer ramp 2816 form a plane between the top surface 2826 and the distal end 2807 and the bottom surface 2828. The first outer ramp 2814 and the second outer ramp 2816 can be formed at an angle relative to the top surface 2826 and the bottom surface 2828. Similarly, the first inner ramp 2818 and the second inner ramp 2820 can be formed at an angle relative to the top surface 2826 and the bottom surface 2828. The intersection of the body 2802 and the folded convex angle 2806 forms a bevel 2822.

[0283] The folding element 2614 also includes pins 2680. Pins 2680 are formed on a first side and a second side of the body 2802. In an embodiment, the folding element 2614 may include two pins 2680 positioned at relative locations on the first and second sides of the body 2802. In an embodiment, pins 2680 may be configured to be movably coupled to a top cam 2622 and a base cam 2626. For example, pins 2680 may be concealed pins, bolts, etc. The pins may be formed to a diameter such that corresponding pin slots 2670 are retained and allow the pin to move within the pin slots. The function of pins 2680 is to movably couple the top cam 2622 and the base cam 2626 to the folding element 2614. Pins 2680 allow the folding element 2614 to move relative to the rotation of the top cam 2622 and the base cam 2626 during operation of the flap folder 2600.

[0284] In an embodiment, the width of the folding element 2614 can range from approximately 25 mm to approximately 50 mm, and the length of the folding element 2614 can range from approximately 1 mm to approximately 40 mm. The slopes (angles relative to the top surface 2826 and bottom surface 2828) of the first outer ramp 2814 and the second outer ramp 2816 can depend on the folding elements included in the flap-type folding device 2600. Similarly, the slopes (angles relative to the top surface 2826 and bottom surface 2728) of the first inner ramp 2818, the second inner ramp 2820, and the bevel 2822 can depend on the folding elements included in the flap-type folding device 2600. In an embodiment, the slope can be determined by dividing 360 degrees by the number of folding elements 2614 in the flap-type folding device 2600. In an embodiment, the number of folding elements can range from 10 to 12. The first internal ramp 2818, the second internal ramp 2820, and the inclined side 2822 are configured to contact the adjacent folding element and produce an iris effect when the folding element is displaced.

[0285] Figures 21E to 21G An example of the dimensions of a folding element 2614 with a 30 mm construction according to an embodiment of this document is shown. For clarity, reference numerals for the folding element 2614 have been omitted and can be found in... Figures 21A to 21D Found in. Table 1 below describes Figures 21E to 21G The dimensions are shown and exemplary dimensional values ​​are provided. Those skilled in the art will recognize that the dimensional values ​​are examples and that the folding element 2614 may have different dimensional values ​​based on the specific construction and folding application of the flap-type folder 2600. Those skilled in the art will recognize that any examples of dimensions described herein are approximate and may vary, for example, by + / - 5.0%, based on manufacturing tolerances, operating conditions, and / or other factors.

[0286] Table 1

[0287]

[0288] In an embodiment, the folding element 2614 is configured to work in combination to produce the iris effect of the flap-type folding device 2600. Figure 21H This is an enlarged side view of several folding elements 2614, with the folding elements 2614 positioned in the fully open position. As shown, the first outer ramp 2814 of the first folding element 2814 rests against the first inner ramp 2816 of the second folding element 2614, thereby forming an overlap. The overlap of the folding elements 2614 defines a folding chamber 2619. During operation, for example, when the actuation handle 2602 moves downward (e.g.... Figure 21H (as shown in the counterclockwise direction), thus causing the cam ( Figure 21HThe top cam 2622 (shown) rotates. The rotation of the top cam 2622 presses the pin 2680 inward. The movement of the pin 2680 presses the folding element 2614 inward. Specifically, the folding element 2614 generally moves inward toward the center of the folding chamber 2619. As the folding element 2614 moves inward, the space available for the folding element 2614 to occupy decreases. Therefore, the space between the folding elements 2614 decreases. Consequently, the first outer ramp 2814 of the first folding element 2614 slides against the first inner ramp 2816 of the second folding element 2614. Accordingly, the area of ​​the folding chamber 2619 decreases.

[0289] Figure 22 A side view of the top cam 2622 and the base cam 2626 in the closed state according to an embodiment herein is shown. Those skilled in the art will recognize that... Figure 22 An example of a top cam / base cam is shown, and Figure 22 The existing components shown can be removed and / or additional components can be added to the top cam 2622 and the base cam 2626.

[0290] As shown in the figure, the top cam 2622 includes a semicircular ring 2902. Similarly, the base cam 2626 includes a semicircular ring 2952. The semicircular ring 2902 includes a handle connection hole 2904 and a pin groove 2670. Similarly, the semicircular ring 2952 includes a pin groove 2670. The top cam 2622 also includes a snap 2640, and the base cam 2626 includes a snap 2642. The snap 2640 is configured to engage with a cam groove 2632, and the snap 2642 is configured to engage with a cam groove 2634. This allows the top cam 2622 and the base cam 2626 to move relative to the top pressure element housing 2620 and the base pressure element housing 2624 when a force is applied to the handle 2602, thereby transmitting the force to the semicircular rings 2902 / 2952 and causing the top cam 2622 and the base cam 2626 to rotate clockwise or counterclockwise (depending on the force applied to the handle 2602).

[0291] When the top cam 2622 and the base cam 2626 are in the closed state, they form a folding chamber 2619. As shown, a pin groove 2670 is formed in a spiral pattern on the top cam 2622 and the base cam 2626. The pin groove 2670 is formed with decreasing distance from the folding chamber 2619. Therefore, as the pin 2680 moves within the pin groove 2670, the pin 2680 moves inward or outward relative to the folding chamber 2619. The inward movement of the pin 2680 causes the folding element 2614 of the top housing 2604 and the base housing 2606 to shift inward within the folding element groove 2630, thereby producing an iris effect. That is, the inward movement of the pin 2680 is transmitted to the folding element 2614, thereby causing the folding element 2614 to shift inward.

[0292] Figure 23 Detailed views of a handle 2602 according to an embodiment herein are shown. Those skilled in the art will recognize that... Figure 23 An example of a handle is shown, and Figure 23 The existing parts shown can be removed and / or additional parts can be added to the handle 2602.

[0293] like Figure 23 (These are side views) As shown, the handle 2602 includes a handle rod portion 3001 and a handle base portion 3002. The handle base portion 3002 includes a top cam connection hole 3006. The top cam connection hole 3006 is configured to connect the handle base portion 3002 to a top cam 2622. The top cam connection hole 3006 is configured to receive a connecting device to connect the handle base portion 3002 to the top cam 2622. The connecting device can be any type of device that connects the handle base portion 3002 to the top cam 2622, such as a bolt, screw, pin, etc.

[0294] Figure 24A and Figure 24B An example of a pleater 3100 according to one embodiment of this document is shown. Those skilled in the art will recognize that... Figure 24A and Figure 24B An example of a pleater is shown, and Figure 24A and Figure 24B The existing components shown can be removed and / or additional components can be added to the folding press 3100. Figure 24A and Figure 24BIn embodiments, as will be described in more detail herein, the folding device 3100 includes a plurality of folding elements configured to apply non-uniform radial compression along the length of the implantable medical device. As used herein, the plurality of folding elements are configured to apply non-uniform radial compression due to their non-uniform shapes. More specifically, the force applied by the folding device 3100 is substantially uniform along the entire length of the folding chamber 3116, but the non-uniform radial shape produced by the assembled folding elements causes the force applied to the implantable medical device to vary along the length of the folding chamber 3116 due to variations in the point of contact with the implantable medical device. For example, a larger diameter folding chamber 3116 applies less force than a smaller diameter folding chamber 3116 because the larger diameter folding chamber 3116 applies force only when it contacts the implantable medical device, while the smaller diameter folding chamber 3116 has already compressed the implant. Therefore, the non-uniform radial compression or force applied to the implantable medical device varies along the length of the force-applied implantable medical device and is not constant.

[0295] A desirable and beneficial scenario is non-uniform radial compression along the length of the implantable medical device. One scenario is preferably compressing the ends of the implantable medical device to facilitate retention on the delivery system. Another scenario could be reducing radial compression in certain portions of the implantable medical device to minimize damage that could result from excessive compression of its vulnerable features. In this case, non-uniform radial compression results in a substantially uniform profile of the implantable medical device in the compressed state, as more force is applied to the denser portions of the implantable medical device (i.e., portions with a higher density relative to other parts of the implantable medical device). As used herein, “substantially uniform profile” includes the implantable medical device having the same diameter along its length in the compressed state after compression, including normal tolerances allowed during manufacturing. Therefore, non-uniform radial compression can improve implant retention force in the delivery system and reduce damage to the implantable medical device from excessive compression of vulnerable areas while minimizing the profile.

[0296] Although the components of the folding device 3100 are described herein using the terms “first,” “second,” “proximal,” and “distal,” those skilled in the art will recognize that the use of these terms is intended only to indicate the components of the folding device 3100 and does not limit any preferred or sequential arrangement of the components of the folding device 3100.

[0297] Furthermore, it will be apparent to those skilled in the art that the folding device 3100 can be modified to have a flip-top configuration as described in the previous embodiments herein, wherein the folding device includes a top iris housing and a base iris housing. The top iris housing can rotate away from the base iris housing to expose a slot for inserting and positioning an implantable medical device and delivery device. When closed, the slot in the base iris housing and the corresponding slot in the top iris housing form a folding chamber surrounding the implantable medical device. The flip-top folding device can then be actuated to reduce the volume of the folding chamber through an iris-type displacement process of the folding element.

[0298] Figure 24A This is a 3D view of the 3100 pleat presser. (See image below.) Figure 24A As shown, the folding clip 3100 includes a handle 3102, a folding clip housing 3104, and a base 3106. The folding clip housing 3104 includes a first side 3103 and a second side 3105 opposite to the first side 3103. The first side 3103 of the folding clip housing 3104 is connected to the second side 3105 of the folding clip housing 3104 via one or more connectors 3107. The connectors 3107 can be any type of device that connects the first side 3103 of the folding clip housing 3104 to the second side 3105 of the folding clip housing 3104, such as bolts, screws, pins, snap-fit ​​features, etc.

[0299] The crease retainer housing 3104 includes an opening 3108 extending through or from a first side 3103 of the crease retainer housing 3104 to a second side 3105 of the crease retainer housing 3104. In an embodiment, the opening 3108 is formed with an approximately circular cross-sectional shape. The opening 3108 opens into the crease chamber 3116 of the crease retainer 3100, as described in further detail below.

[0300] The base 3106 of the folding presser 3100 is formed as a rectangular plate. The base 3106 may be configured to extend in width and length beyond the length and width of the folding presser housing 3104 and the handle 3102. The base 3106 provides a stable platform for operating the folding presser 3100 during the folding process. The folding presser housing 3104 is attached to or secured to the base 3106 via one or more connecting devices 3120. The connecting device 3120 may be any type of device that connects the folding presser housing 3104 to the base 3106, such as bolts, screws, pins, snap-fit ​​features, etc.

[0301] Figure 24BA perspective view of a folding presser 3100 is shown, with the first side 3103 of the folding presser housing 3104 removed to reveal the internal components of the folding presser 3100. The folding presser 3100 includes a cam 3110, a plurality of levers 3118, and a plurality of folding elements 3114 forming a folding chamber 3116. A handle 3102 is connected to the cam 3110 via a gear 3112, as will be described in more detail herein. The cam 3110 is connected to the plurality of folding elements 3114 via the plurality of levers 3118. To operate the folding presser 3100, the user applies force to the handle 3102 in a direction toward the base 3106. The force applied to the handle 3102 via the gear 3112 causes the gear 3112 to rotate clockwise, which in turn causes the cam 3110 to rotate counterclockwise. The rotation of the cam 3110 causes the folding elements 3112 to move radially inward, as will be described in more detail herein.

[0302] In this embodiment, the folding device 3100 functions to convert the implantable medical device from its uncompressed state to its compressed state. In operation, the implantable medical device is loaded into the folding chamber 3116. Those skilled in the art will appreciate that the dimensions of the convex angle can be varied to produce different volumes depending on the needs of the compressed and positioned implantable medical device. The delivery device for the implantable medical device can also be positioned and aligned relative to the implantable medical device. The folding device 3100 is then changed from an open state to a closed state by actuation of the handle 3102, converting the implantable medical device from its uncompressed state to its compressed state and loading the implantable medical device onto the delivery device. As the folding elements 3114 move radially inward, the space available for the folding elements 3114 decreases, and therefore the space between the folding elements 3114 decreases. Consequently, the volume of the folding chamber 3116 decreases, and the folding elements 3114 apply compressive force to the outer surface of the implantable medical device to fold the implantable medical device from an uncompressed or radially expanded state into a radially compressed state. For example, if the implantable medical device is generally cylindrical, when the handle 3102 is actuated, the pressure-bending element 3114 applies force from multiple different directions on the surface of the implantable medical device, thereby compressing the implantable medical device. (As will be referenced herein...) Figures 29A to 29C In a more detailed description, in this embodiment, the compression element 3114 is configured to apply uneven radial compression along the length of the implantable medical device. Reference will be made below. Figure 39A The operation of the folding device 3100 is further explained in Figure 39E.

[0303] The folding device 3100 also includes a first stop 3150 and a second stop 3152. The first stop 3150 and the second stop 3152 provide surfaces that stop the handle 3102 from moving in the downward direction. The first stop 3150 and the second stop 3152 provide a predetermined stop position for the handle 3102 corresponding to or causing the folding chamber 3116 to reach a predetermined diameter. That is, the first stop 3150 and the second stop 3152 are physical stops that cause the implanted medical device to be compressed to a predetermined diameter or degree of compression. For example, the first stop 3150 may function to allow the implanted medical device to be partially compressed. Similarly, for example, the second stop 3152 may function to allow the implanted medical device to be fully compressed. The first stop 3150 and the second stop 3152 may be detachably attached to the folding device housing 3104. Therefore, the first stop 3150 and / or the second stop 3152 can be added and / or removed to allow the implantable medical device to be compressed to a predetermined diameter.

[0304] The internal components of the folding device 3100 and its operation will now be described in more detail in this article. Figure 25A , Figure 25B and Figure 25C Perspective views, side views, and exploded views of the handle 3102 and gear 3112 sub-assemblies of the folding device 3100 are depicted, respectively. Those skilled in the art will recognize that... Figures 25A to 25C An example of a handle-gear subassembly is shown, and Figures 25A to 25C The existing parts shown can be removed and / or additional parts can be added to the handle-gear subassembly.

[0305] The handle 3102 is accessible to the user and is connected to the folding device housing 3104. The handle 3102 includes a first side 3102A and a second side 3102B opposite to the first side 3102A. The first side 3102A of the handle 3102 is formed as a "mirror image" of the second side 3102B of the handle 3102 and is connected to the second side 3102B to jointly form the handle 3102. The first side 3102A of the handle 3102 is connected to the second side 3102B of the handle 3102 via one or more connectors 3102C. The connectors 3107 can be any type of device that connects the first side 3103 of the folding device housing 3104 to the second side 3105 of the folding device housing 3104, such as bolts, screws, pins, etc. Furthermore, the first side 3102A of the handle 3102 is connected to the second side 3102B of the handle 3102 via a gear 3112, as will be described in more detail with respect to FIG. 28C.

[0306] The handle 3102 includes a first end 3121 and a second end, or the opposite end 3123. The first end 3121 of the handle 3102 is connected to the folding device housing 3104, and the second end 3123 is free or not attached to the folding device housing 3104. At its first end 3121, a first side 3102A and a second side 3102B are connected to the folding device housing 3104 and to a gear 3112 disposed within the folding device housing 3104. At its second end 3123, the first side 3102A and the second side 3102B together have a spherical structure to facilitate operation by the user while manipulating the handle 3102. When the user rotates the handle 3102 to operate the folding device 3100, the user typically grasps or holds the second end 3123 of the handle 3102.

[0307] At its first end 3121, the first side 3102A and the second side 3102B of the handle 3102 are spaced apart, forming a gap between them. The size and construction of the gap allow it to receive the gear 3112. On the inner surface of the first side 3102A, a protrusion or buckle 3131A extends inward toward the second side 3102B. Similarly, on the inner surface of the second side 3102B, a protrusion or buckle 3131B extends inward toward the first side 3102A. The size and construction of the protrusions 3131A and 3131B allow them to be received in corresponding recesses 3133A and 3133B of the gear 3112, respectively, to connect the first side 3102A and the second side 3102B to the gear 3112. By forming the gear 3112 and the handle 3102 as separate components, the sub-assembly is more robust and less prone to breakage. Furthermore, forming the gear 3112 and the handle 3102 as separate components simplifies their manufacturing. Gear 3112 is a cylindrical component having a plurality of teeth circumferentially formed around its outer surface. As will be described in more detail below, gear 3112 is configured to engage with gear portion 3113 of cam 3110. In other words, gear 3112 includes a plurality of teeth on its outer surface, the size and shape of which enable it to engage or mesh with the plurality of teeth of gear portion 3113 of cam 3110.

[0308] Figure 26A and Figure 26B A side view and a perspective view of the second side 3105 of the folding device housing 3104 are depicted, respectively. Those skilled in the art will recognize that... Figure 26A and Figure 26B An example of the side of the folding housing 3104 is shown, and Figure 26A and Figure 26B The existing components shown can be removed and / or additional components can be added to the second side 3105. Furthermore, although only the second side 3105 of the folder housing 3104 is described in detail below, those skilled in the art will recognize that the first side 3103 of the folder housing 3104 includes components related to… Figure 26A and Figure 26B The same components are shown. For example, the first side 3103 of the folding housing 3104 is formed as a "mirror image" of the second side 3105 of the folding housing 3104, and is connected to the second side 3105 to jointly form the folding housing 3104.

[0309] The second side 3105 of the folding device housing 3104 includes an inner surface 3302 and an opposite outer surface (not shown). The second side 3105 includes an opening 3108 that opens into a folding chamber 3116 formed by the folding element 3114. The second side 3105 also includes a handle opening 3304 that is formed through and configured to receive a handle 3102. The handle opening 3304 is also configured to receive a first stop 3150 and a second stop 3152. Folding element grooves 3306 are formed on the inner surface 3302 of the second side 3105. Each folding element groove 3306 may be formed as a generally rectangular recess or slot extending inwardly from the center of the second side 3105 toward the opening 3108 in a generally radial direction. The folding element grooves 3306 are formed arcuately around the second side 3105 and are arranged in equal increments spaced circumferentially around the opening 3108. The central annular cavity 3306A is a circular groove or slot formed on the inner surface 3302 of the second side 3105, surrounding or enclosing the opening 3108. The depth of the central annular cavity 3306A is the same as that of the pressure-bending element groove 3306, and the pressure-bending element groove 3306 extends to or terminates in the central annular cavity 3306A. Therefore, the pressure-bending element groove 3306 and the central annular cavity 3306A form a continuous groove or cavity formed on the inner surface 3302 of the second side 3105.

[0310] The folding element groove 3306 and the central annular cavity 3306A are configured to movably fix the folding element 3114 within the folding device housing 3104. (As mentioned above...) Figure 13C As described in the folding element groove 2006, the folding element groove 3306 is formed in such a way that it accommodates the folding element 3114 when the second side 3105 of the folding housing 3104 mates with the first side 3103 of the folding housing 3104. As described above, the folding element groove 3306 is formed in an arc around the second side 3105. In an embodiment, as described above regarding Figure 13C As described in the 2006 pressure-bending element groove, each pressure-bending element groove 3306 and the adjacent pressure-bending element groove 3306 are arranged in an arc at an angle. δ The slots are spaced apart, and each of the pressure-bending element slots 3306 can be aligned with an offset angle relative to the radius line of the second side 3105. This offset can cause the pressure element 3114 to move in a direction away from the center point of the second side 3105. In some embodiments, the angle It can be in the range of approximately 0 degrees to 30 degrees.

[0311] The folding element slot 3306 also serves to limit the outward radial movement or travel of the folding element 3114 to ensure that the folding chamber 3116 does not unintentionally over-open. If the outward radial movement or travel of the folding element 3114 is not restricted in any way, the folding chamber 3116 may continue to open to a size or dimension such that the portions of the folding element 3114 no longer overlap, and the resulting gaps may trap and damage the implanted medical device disposed within the folding chamber 3116. In other words, the folding element slot 3306 is configured to set or limit the maximum diameter of the folding chamber 3116. In one embodiment, the size of each folding element slot 3306 is set to limit the travel of the folding element 3114 and thereby set or limit the maximum diameter of the folding chamber 3116. In another embodiment, the size of at least one folding element slot 3306 is set to limit the travel of the folding element 3114 and thereby set or limit the maximum diameter of the folding chamber 3116. In such an embodiment, at least one folding element slot is shorter than the others. In another embodiment, the size of the two to six folding element slots 3306 can be set to restrict the travel of the folding element 3114 and thereby set or limit the maximum diameter of the folding chamber 3116. In such an embodiment, the two to six folding element slots are shorter than the remaining folding element slots.

[0312] Figure 27A and Figure 27B Side and perspective views of a cam 3110 according to embodiments herein are depicted. Those skilled in the art will recognize that... Figure 27A and Figure 27B An example of a cam is shown, and Figure 27A and Figure 27B The existing components shown can be removed and / or additional components can be added to the cam 3110. The cam 3110 is an annular element or ring disposed within the presser housing 3104.

[0313] The function of the cam 3110 is to transmit the rotational motion of the handle 3102 to the pressing element 3114 via the lever 3118. As the handle 3102 moves, the cam 3110 rotates and converts or transforms the rotational motion of the handle 3102 into the linear motion of the pressing element 3114 via the lever 3118. The cam 3110 includes a plurality of integrally formed teeth or gear portions 3113 on its outer surface. The gear portions 3113 are configured to mesh with gears 3112. More specifically, the size and shape of the plurality of teeth of the gear portions 3113 are configured to mesh or engage with the plurality of teeth of gears 3112, such that rotation of gears 3112 causes rotation of the cam 3110. The gear portions 3113 and gears 3112 are oriented in opposite directions, such that rotation of gears 3112 in a first direction causes rotation of the cam 3110 in a second direction or the opposite direction. When positioned within the folding housing 3104, the cam 3110 is oriented such that the gear portion 3113 engages with the gear 3112 near the handle opening 3304 of the folding housing 3104.

[0314] like Figure 27A and Figure 27B As shown, the cam 3110 includes a plurality of rod slots or recesses 3111. Each rod slot 3111 is configured to receive a rod 3118. A connecting hole 3406 extends through the cam 3110 and is disposed within each rod slot 3111. Each connecting hole 3406 is configured to receive a pin (not shown) that connects the cam 3110 to the rod 3118 disposed within the rod slot 3111. In other words, the cam 3110 is connected to the rod 3118 using a plurality of pins, wherein each pin passes through the connecting hole 3406 and through a similar connecting hole through the rod 3118. For example, the pins may be concealed pins, bolts, etc. The rod slots 3111 are also configured to restrict the rotational movement of the rod 3118, as described in more detail herein.

[0315] Figure 28A and Figure 28B A perspective view and a front view of the rod 3118 are depicted respectively. Those skilled in the art will recognize that... Figures 28A to 28B An example of a bar is shown, and Figures 28A to 28B The existing components shown can be removed and / or additional components can be added to the bar 3118. Although only one bar 3118 is described in detail, those skilled in the art will recognize that the construction of all bars 3118 in the folding device 3100 and the components they include are similar to those in the folding device 3100. Figures 28A to 28B The bar 3118 described in the text is the same.

[0316] A lever 3118 is disposed within each lever slot 3111, and its function or role is to connect the cam 3110 to a plurality of pressing elements 3114. Each of the plurality of levers 3118 extends from the cam 3110 to the middle region of one of the pressing elements 3114. The lever 3118 is rotatably connected to the cam 3110. That is, when the cam 3110 rotates in response to the movement of the handle 3102, the lever 3118 is allowed to rotate relative to the cam 3110. Similarly, the lever 3118 is rotatably connected to the pressing element 3114. That is, when the lever 3118 moves in response to the rotation of the cam 3110, the pressing element 3114 is allowed to rotate relative to the lever 3118. In some embodiments, the construction of the lever 3118 and the components included therein may be similar to those described above. Figure 4 or Figure 15A and Figure 15B As stated above.

[0317] As shown in the figure, the lever 3118 includes a base 3502 and two parallel legs 3504 extending from the base 3502. Each leg 3504 of the lever 3118 includes a connecting hole 3508. Upon assembly, the connecting holes 3508 are aligned with the connecting holes 3506 of the cam 3110, as described above. The size and shape of the connecting holes 3508 are similar to the connecting holes 3406 of the cam 3110, and are configured to receive a pin (not shown) that connects the cam 3110 to the lever 3118. In other words, the cam 3110 and the lever 3118 are connected using multiple pins, each pin passing through the connecting hole 3406 of the cam 3110 and through the connecting hole 3508 of the lever 3118. For example, the pins can be concealed pins, bolts, etc. The pins can be shaped to a diameter such that a corresponding circular opening is retained, allowing the pin to operate as a fulcrum. When the cam 3110 rotates clockwise or counterclockwise, the combination of the pin and the connecting hole 3508 allows the rod 3118 to rotate about the pin, and the movement of the rod 3118 is restricted by the rod groove 3111 of the cam 3110. Therefore, the rod groove 3111 of the cam 3110 is configured to provide clearance and allow the rod 3118 to rotate relative to the cam 3110. When assembled onto the cam 3110, the cam 3110 is positioned within the space between the legs 3504 of the rod 3118, and the connecting holes 3508 of the legs 3504 are aligned with the connecting holes 3406 of the cam 3110.

[0318] The base 3502 may include a circular end portion 3506A formed in a semi-cylindrical shape. The circular end portion 3506A includes a through-hole 3506. Each through-hole 3506 is configured to receive a pin (not shown) for connecting the rod 3118 to the bending element 3114. In other words, multiple pins are used to connect the rod 3118 to the bending element 3114, each pin passing through the through-hole 3506 and a similar through-hole in the bending element 3114. For example, the pins may be concealed pins, bolts, etc. After assembly, the through-holes 3506 and the bending elements 3114 are aligned, and the aligned through-holes and the pins function to movably connect the bending element 3114 to the rod 3118.

[0319] Each lever 3118 is a relatively rigid element, exhibiting minimal or no bending and / or deformation during operation of the folding device 3100. Because one end of each lever 3118 is fixed to the cam 3110, and the opposite end is fixed to one of the folding elements 3114, the distance 3110 between the connection between the lever 3118 and the cam and the connection between the lever 3118 and the folding element 3114 must remain constant as the cam 3110 rotates. However, this constant distance is only maintained when the cam 3110 rotates, as it pushes the folding element 3114 inward radially via the lever 3118. Therefore, the rotation of the cam 3110 presses the folding element 3114 inward via the lever 3118. Specifically, the folding element 3114 generally moves inward radially toward the center of the folding chamber 3116.

[0320] Figures 29A to 29C Different views of the folding element 3114 according to embodiments herein are shown. Those skilled in the art will recognize that... Figures 29A to 29C An example of a folded element is shown, and Figures 29A to 29C The existing components shown can be removed and / or additional components can be added to the folding element 3114. Although only one folding element 3114 is described in detail, those skilled in the art will recognize that the construction of all folding elements 3114 of the folding device 3100 and the components they include are similar to those of other folding elements 3114. Figures 29A to 29C The folding element 3114 described herein is the same. In operation, the folding element 3114 is displaced by the movement of the handle 3102. That is, as the handle 3102 moves, the cam 3110 rotates and converts the rotational motion of the handle 3102 into linear motion of the folding element 3114 via the lever 3118. Therefore, the folding element 3114 acts as an iris, causing the volume of the folding chamber 3116 to decrease or increase by the movement of the handle 3102.

[0321] Each folding element 3114 has a first leg 3635A, a second leg 3635B, and a folding convex angle 3637 that connects to and extends between the first leg 3635A and the second leg 3635B. The first leg 3635A and the second leg 3635B extend parallel to the long axis of the folding element 3114 from the proximal end 3639 of the folding element 3114 to the folding convex angle 3637. The first leg 3635A and the second leg 3635B are spaced apart and define a bar groove 3641 between them. A connecting hole 3669 is formed in each of the first leg 3635A and the second leg 3635B, such that the folding element 3114 includes a total of two connecting holes. In an embodiment, the connecting hole 3112 may be configured to receive a pin passing through the two connecting holes 3669 and the connecting hole 3506 of the bar 3118. For example, the pin may be a concealed pin, a bolt, etc. The pin can be formed to a diameter such that a corresponding circular opening is maintained and the pin acts as a fulcrum for operation. The connecting hole 3669 serves to movably connect the folding element 3114 to the rod 3118. The rod 3118 is disposed within the rod groove 3641 of the folding element 3114, between the legs 3635A and 3635B of the folding element 3114, and the connecting hole 3506 of the rod 3118 is aligned with the connecting hole 3669 of the folding element 3114. The size of the rod groove 3641 is designed to allow the rod 3118 to rotate relative to the folding element 3114 during operation of the folding device 3100.

[0322] In an embodiment, the folding element 3114 may include inclined shoulders 3663A and 3663B, respectively formed on the first leg 3635A and the second leg 3635B, located at the intersection of the leg and the folding convex angle 3637. The inclined shoulders 3663A and 3663B serve to hold the first leg 3635A and the second leg 3635B within corresponding folding element grooves 3306 on the inner surface 3302 of the second side 3105 of the folding device housing 3104. That is, the inclined shoulders 3663A and 3663B are formed on the first leg 3635A and the second leg 3635B to extend along the width of the folding element 3114, thereby engaging one or more corresponding folding element grooves 3306. In an embodiment, the width of the folding element 3114 may be specific to the size of the implantable medical device being folded. Therefore, the size of the tilted shoulder 3663A, 3663B can vary based on the size of the implanted medical device being folded.

[0323] A folding convex angle 3637 extends from the first leg 3635A and the second leg 3635B to the distal end 3643 of the folding element 3114. The folding convex angle 3637 defines a folding space 3645, or in other words, includes the folding space 3645 defined therein. The folding space 3645 is configured to receive or accommodate adjacent or neighboring folding elements 3114 when the folder 3100 is operated and the size or volume of the folding chamber 3116 decreases. More specifically, the folding element 3114 includes a first side or outer surface 3647 and a second side or inner surface 3649 formed on its opposite side. When assembled into the folder 3100, the outer surface 3647 of the folding element 3114 is arranged adjacent to the inner surface 3649 of a neighboring folding element, such that the folding element 3114 is received in the folding space 3645 of the neighboring folding element. The outer surface 3647 may include one or more shaped protrusions 3647A, which are sized and shaped to be received within one or more corresponding recesses 3649A formed on the inner surface 3649 of an adjacent folding element. During operation of the folding device 3100, the mating protrusions 3647A and recesses 3649A guide or assist relative sliding movement between adjacent folding elements.

[0324] Along the outer surface 3647 of the folding protrusion 3637, the folding protrusion 3637 includes a first outer slope 3657A and a second outer slope 3657B. The first outer slope 3657A and the second outer slope 3657B are inclined surfaces relative to the major axis of the folding element 3114. Along the inner surface 3649 of the folding protrusion 3637, the folding protrusion 3637 includes a first inner slope 3659A and a second inner slope 3659B. The first inner slope 3659A and the second inner slope 3659B define a folding space 3645 and are therefore configured to contact an adjacent folding element to produce an iris effect when the folding element is displaced. The first inner slope 3659A and the second inner slope 3659B may be at an angle relative to the major axis of the folding element 3114.

[0325] The size of the folding element 3114 can be determined by the size of the object being folded. In an embodiment, the axial length of the folding chamber 3116 can range from about 20 mm to about 50 mm, and its diameter can range from about 1 mm to about 40 mm. In an embodiment, the angle formed between the second outer ramp 3657B and the first inner ramp 3659A depends on the folding elements included in the folder 3100. More specifically, the angle formed between the second outer ramp 3657B and the first inner ramp 3659A can be determined by dividing 360 degrees by the number of folding elements 3114 in the folder 3100. In an embodiment, the number of folding elements can range from 8 to 16. In another embodiment, the number of folding elements can range from 10 to 12. The angle or slope of each ramp in the first outer ramp 3657A and the second inner ramp 3659B is set or configured to allow the folding elements 3114 to give way to each other during operation of the folder 3100.

[0326] The folding element 3114 is configured to apply uneven radial compression along the length of the implantable medical device. More specifically, during operation of the folding device 3100, at least a portion of the second outer ramp 3657B of the folding element 3114 contacts the implantable medical device disposed within the folding chamber 3116. The second outer ramp 3657B is a non-planar surface that applies uneven radial compression along the length of the implantable medical device. As used herein, "non-planar" includes surfaces comprising two or more integral portions not located in the same plane, these integral portions being disposed at different distances from the centerline or longitudinal axis of the folding chamber. Figures 29A to 29CIn one embodiment, the second outer ramp 3657B includes a ridge 3673 formed thereon, which effectively divides the second outer ramp 3657B into a first longitudinal portion 3675A and a second longitudinal portion 3675B. In one embodiment, the first longitudinal portion 3675A extends between 35% and 45% of the total length of the folding chamber 3116, and the second longitudinal portion 3675B extends between 55% and 65% of the total length of the folding chamber 3116. The ridge 3673 is a curved surface extending between the first longitudinal portion 3675A and the second longitudinal portion 3675B such that the first longitudinal portion 3675A and the second longitudinal portion 3675B are positioned at different radial locations within the folding chamber 3116. In the described embodiment, the second longitudinal portion 3675B is positioned closer to the centerline or longitudinal axis of the folding chamber 3116 than the first longitudinal portion 3675A. Due to the different radial positions, the second longitudinal portion 3675B is configured to apply more radial force to the implantable medical device during the compression process compared to the first longitudinal portion 3675A. In other words, the first radial force is applied to the first segment of the implantable medical device through the non-planar surface of the second outer ramp 3657B via the first longitudinal portion 3675A, and the second radial force is applied to the second segment of the implantable medical device through the non-planar surface of the second outer ramp 3657B, and the second radial force is greater than the first radial force.

[0327] Figure 30A and Figure 30B An end view and a side view of a folding chamber 3116 formed by a folding element 3114 are depicted. At the first end of the folding chamber 3116, the folding chamber 3116 has a first diameter D formed by the first longitudinal portion 3675A of the folding element 3114. A At the second end of the folding chamber 3116, the folding chamber 3116 has a second diameter D formed by the second longitudinal portion 3675B of the folding element 3114. B Because the radial positions of the first longitudinal portion 3675A and the second longitudinal portion 3675B are different, the first diameter D A Greater than the second diameter D BBecause the first longitudinal portion 3675A of the folding element 3114 is positioned further away from the centerline or longitudinal axis of the folding chamber 3116 than the second longitudinal portion 3675B of the folding element 3114, the diameter of the folding chamber 3116 increases along the first longitudinal portion 3675A. Conversely, because the second longitudinal portion 3675B of the folding element 3114 is positioned closer to the centerline or longitudinal axis of the folding chamber 3116 than the first longitudinal portion 3675A of the folding element 3114, the diameter of the folding chamber 3116 decreases along the second longitudinal portion 3675B. Compared to the radial force applied to the implantable medical device along the first longitudinal portion 3675A of the folding element 3114, the smaller diameter (i.e., the second diameter D) results in a smaller diameter. B This results in a higher or greater radial force being applied to the implantable medical device along the second longitudinal portion 3675B of the compression element 3114. When the implantable medical device includes sections of denser material (such as the valve portion), it is beneficial to apply a higher radial force only along a portion of the implantable medical device. In this case, because more radial force is applied to the denser portion of the implantable medical device via the second longitudinal portion 3675B of the compression element 3114, the uneven radial compression results in a substantially uniform profile of the implantable medical device in the compressed state. The first longitudinal portion 3675A of the compression element 3114 applies less radial force to the less dense or vulnerable portions of the implantable medical device to avoid damage. Once compression is performed via uneven radial compression applied through the compression element 3114, the compression profile of the implantable medical device is more uniform or consistent along its length compared to the profile achieved through uniform radial compression.

[0328] Figures 31A to 31B Different views of the folding element 3814, which can be used in a folding device 3100 or other folding devices described herein, according to another embodiment of this document, are shown. Those skilled in the art will recognize that... Figures 31A to 31B An example of a folded element is shown, and Figures 31A to 31B The existing components shown can be removed and / or additional components can be added to the folding element 3814. Although only one folding element 3814 is described in detail, those skilled in the art will recognize that the construction of all folding elements 3814 of the folding device 3100 and the components they include are similar to... Figures 31A to 31B The pressure-bending element 3814 described in the text is the same.

[0329] Similar to the folding element 3114, each folding element 3814 has a first leg 3835A, a second leg 3835B, and a folding convex angle 3837 connected to and extending between the first leg 3835A and the second leg 3835B. The first leg 3835A and the second leg 3835B extend parallel to the long axis of the folding element 3814 from the proximal end 3839 of the folding element 3814 to the folding convex angle 3837. The folding convex angle 3837 extends from the first leg 3835A and the second leg 3835B to the distal end 3843 of the folding element 3814. The folding convex angle 3837 defines a folding space 3845, or in other words, includes the folding space 3845 defined therein. The folding space 3845 is configured to receive or accommodate adjacent or neighboring folding elements 3814 when the folding presser 3100 is operated and the size or volume of the folding chamber 3816 decreases. More specifically, the folding element 3814 includes a first side or outer surface 3847 and a second side or inner surface 3849 formed on its opposite side. When assembled into the folding presser 3100, the outer surface 3847 of the folding element 3814 is positioned adjacent to the inner surface 3849 of a neighboring folding element, such that the folding element 3814 is received in the folding space 3845 of the neighboring folding element. The first outer ramp 3857A and the second outer ramp 3857B are inclined surfaces relative to the long axis of the folding element 3814. Along the inner surface 3849 of the folding convex angle 3837, the folding convex angle 3837 includes a first inner ramp 3859A and a second inner ramp 3859B. The first inner ramp 3859A and the second inner ramp 3859B define the folding space 3845 and are thus configured to contact the adjacent folding element to produce an iris effect when the folding element is displaced. The first inner ramp 3859A and the second inner ramp 3859B are inclined surfaces relative to the long axis of the folding element 3814.

[0330] Similar to the folding element 3114, the folding element 3814 is also configured to apply uneven radial compression along the length of the implantable medical device. More specifically, during operation of the folding device 3100, at least a portion of the second outer ramp 3857B of the folding element 3814 contacts the implantable medical device disposed within the folding chamber 3816. The second outer ramp 3857B is a non-planar surface that applies uneven radial compression along the length of the implantable medical device. Figures 31A to 31BIn one embodiment, the second external ramp 3857B includes three longitudinal portions disposed at different radial positions within the folding chamber 3816, specifically a first longitudinal portion 3875A, a second longitudinal portion 3875B, and a third longitudinal portion 3875C. The second longitudinal portion 3875B is disposed between the first longitudinal portion 3875A and the third longitudinal portion 3875C. In the described embodiment, the first longitudinal portion 3875A and the third longitudinal portion 3875C each taper gradually towards the second longitudinal portion 3875B along their length. The first longitudinal portion 3875A and the third longitudinal portion 3875C are each configured to be closer to the centerline or longitudinal axis of the folding chamber 3816 than the second longitudinal portion 3875B. Due to their different radial positions, the first longitudinal portion 3875A and the third longitudinal portion 3875C are configured to apply more radial force to the implanted medical device during folding compared to the second longitudinal portion 3875B.

[0331] Figure 32A and Figure 32B An end view and a side view of a folding chamber 3816 formed by a folding element 3814 are depicted. At the first end of the folding chamber 3816, the folding chamber 3816 has a first diameter D formed by the first longitudinal portion 3875A of the folding element 3814. A Similarly, at the second end of the folding chamber 3816, the folding chamber 3816 also has a diameter D formed by the third longitudinal portion 3875C of the folding element 3814. A In the middle of the folding chamber 3816, along the second longitudinal portion 3875B, the folding chamber 3816 has a second diameter D formed by the second longitudinal portion 3875B of the folding element 3814. B Because the radial positions of the first longitudinal portion 3875A, the second longitudinal portion 3875B, and the third longitudinal portion 3875C are different, the first diameter D... A Smaller than the second diameter D B Because the second longitudinal portion 3875B of the folding element 3814 is positioned further away from the centerline or longitudinal axis of the folding chamber 3816 than the first longitudinal portions 3875A and 3875C of the folding element 3814, the diameter of the folding chamber 3816 increases along the second longitudinal portion 3875B. Conversely, because the first longitudinal portions 3875A and 3875C of the folding element 3814 are positioned closer to the centerline or longitudinal axis of the folding chamber 3816 than the second longitudinal portion 3875B of the folding element 3814, the diameter of the folding chamber 3816 decreases along the first longitudinal portions 3875A and 3875C. Compared to the radial force applied to the implantable medical device along the second longitudinal portion 3875B of the folding element 3814, the smaller diameter (i.e., the first diameter D) results in a smaller diameter.A This results in higher or greater radial forces applied to the implantable medical device along the first longitudinal portion 3875A and the third longitudinal portion 3875C of the folding element 3814. Applying a higher radial force only along the end portion of the implantable medical device is beneficial for retaining the implantable medical device on the delivery system. Applying more radial force to the end portion of the implantable medical device preferably folds the end portion of the implantable medical device onto the delivery system.

[0332] Figures 33A to 33B Different views of the folding element 4014, which can be used in folding device 3100 or other folding devices described herein, according to another embodiment of this document, are shown. Those skilled in the art will recognize that... Figures 33A to 33B An example of a folded element is shown, and Figures 33A to 33B The existing components shown can be removed and / or additional components can be added to the folding element 4014. Although only one folding element 4014 is described in detail, those skilled in the art will recognize that the construction of all folding elements 4014 of the folding device 3100 and the components they include are similar to... Figures 33A to 33B The pressure-bending element 4014 described in the text is the same.

[0333] Similar to the folding element 3114, each folding element 4014 has a first leg 4035A, a second leg 4035B, and a folding convex angle 4037 connected to and extending between the first leg 4035A and the second leg 4035B. The first leg 4035A and the second leg 4035B extend parallel to the long axis of the folding element 4014 from the proximal end 4039 of the folding element 4014 to the folding convex angle 4037. The folding convex angle 4037 extends from the first leg 4035A and the second leg 4035B to the distal end 4043 of the folding element 4014. The folding convex angle 4037 defines a folding space 4045, or in other words, includes the folding space 4045 defined therein. The folding space 4045 is configured to receive or accommodate adjacent or neighboring folding elements 4014 when the folding presser 3100 is operated and the size or volume of the folding chamber 4016 decreases. More specifically, the folding element 4014 includes a first side or outer surface 4047 and a second side or inner surface 4049 formed on its opposite side. When assembled into the folding presser 3100, the outer surface 4047 of the folding element 4014 is positioned adjacent to the inner surface 4049 of a neighboring folding element, such that the folding element 4014 is received in the folding space 4045 of the neighboring folding element. The first outer ramp 4057A and the second outer ramp 4057B are inclined surfaces relative to the long axis of the folding element 4014. Along the inner surface 4049 of the folding convex angle 4037, the folding convex angle 4037 includes a first inner ramp 4059A and a second inner ramp 4059B. The first inner ramp 4059A and the second inner ramp 4059B define the folding space 4045 and are thus configured to contact the adjacent folding element to produce an iris effect when the folding element is displaced. The first inner ramp 4059A and the second inner ramp 4059B are inclined surfaces relative to the long axis of the folding element 4014.

[0334] Similar to the folding element 3114, the folding element 4014 is also configured to apply uneven radial compression along the length of the implantable medical device. More specifically, during operation of the folding device 3100, at least a portion of the second outer ramp 4057B of the folding element 4014 contacts the implantable medical device disposed within the folding chamber 4016. The second outer ramp 4057B is a non-planar surface that applies uneven radial compression along the length of the implantable medical device. Figures 33A to 33B In one embodiment, the second external ramp 4057B includes three longitudinal portions disposed at different radial positions within the compression chamber 4016, specifically a first longitudinal portion 4075A, a second longitudinal portion 4075B, and a third longitudinal portion 4075C. The second longitudinal portion 4075B is disposed between the first longitudinal portion 4075A and the third longitudinal portion 4075C. Figures 33A to 33BIn one embodiment, the second outer ramp 4057B includes a first ridge 4073A formed thereon that bridges or extends between the first longitudinal portion 4075A and the second longitudinal portion 4075B, and a second ridge 4073B formed thereon that bridges or extends between the second longitudinal portion 4075B and the third longitudinal portion 4075C. The first ridge 4073A and the second ridge 4073B are each curved surfaces extending between the respective longitudinal portions, such that the respective longitudinal portions are positioned at different radial locations within the compression chamber 4016.

[0335] Figure 34A and Figure 34B An end view and a side view of a folding chamber 4016 formed by a folding element 4014 are depicted. At the first end of the folding chamber 4016, the folding chamber 4016 has a first diameter D formed by a first longitudinal portion 4075A of the folding element 4014. A Similarly, at the second end of the folding chamber 4016, the folding chamber 4016 also has a diameter D formed by the third longitudinal portion 4075C of the folding element 4014. A Along the second longitudinal portion 4075B, the folding chamber 4016 has a second diameter D formed by the second longitudinal portion 4075B of the folding element 4014. B Because the radial positions of the first longitudinal portion 4075A, the second longitudinal portion 4075B, and the third longitudinal portion 4075C are different, the first diameter D... A Smaller than the second diameter D B Because the second longitudinal portion 4075B of the folding element 4014 is positioned further away from the centerline or longitudinal axis of the folding chamber 4016 than the first longitudinal portion 4075A and the third longitudinal portion 4075C of the folding element 4014, the diameter of the folding chamber 4016 increases along the second longitudinal portion 4075B. Conversely, because the first longitudinal portion 4075A and the third longitudinal portion 4075C of the folding element 4014 are positioned closer to the centerline or longitudinal axis of the folding chamber 4016 than the second longitudinal portion 4075B of the folding element 4014, the diameter of the folding chamber 4016 decreases along the first longitudinal portion 4075A and the third longitudinal portion 4075C. Compared to the radial force applied to the implantable medical device along the second longitudinal portion 4075B of the folding element 4014, the smaller diameter (i.e., the first diameter D) results in a smaller diameter. A This results in higher or greater radial forces being applied to the implantable medical device along the first longitudinal portion 4075A and the third longitudinal portion 4075C of the compression element 4014.

[0336] exist Figures 33A to 33BIn one embodiment, the first longitudinal portion 4075A is the longest longitudinal portion and extends to between 55% and 65% of the total length of the folding chamber 4016. The second longitudinal portion 4075B extends to between 25% and 35% of the total length of the folding chamber 4016, and the third longitudinal portion 4075C extends to between 5% and 15% of the total length of the folding chamber 4016. (See reference...) Figure 40A The first longitudinal portion 4075A is configured to contact nodes 4785 at the L0, L1, L2, and L3 levels of the artificial heart valve 4702. The second longitudinal portion 4075B is configured to contact node 4785 at the L4 level of the artificial heart valve 4702, and the third longitudinal portion 4075C is configured to contact node 4785 at the L5 level of the artificial heart valve 4702.

[0337] In the described embodiment, the first longitudinal portion 4075A and the third longitudinal portion 4075C are each positioned closer to the centerline or longitudinal axis of the compression chamber 4016 than the second longitudinal portion 3675B. Due to the different radial positions, the first longitudinal portion 4075A and the third longitudinal portion 4075C are configured to apply more radial force to the implantable medical device during compression compared to the second longitudinal portion 4075B. Therefore, when used with the artificial heart valve 4702, more radial force is applied via the first longitudinal portion 4075A and the third longitudinal portion 4075C to the nodes 4785 at the L0, L1, L2, L3, and L5 levels, while less radial force is applied to the node 4785 at the L4 level of the artificial heart valve 4702. It is desirable to apply less radial force to the L4-level node 4785 of the artificial heart valve 4702 because the L4-level node 4785 is adjacent to the terminal outflow side opening 4789B, which has a lower density compared to other parts of the artificial heart valve 4702 and does not require as much radial force to achieve the desired fold profile. More specifically, the first longitudinal portion 4075A of the folding element 4014 is configured to apply higher radial force along sections of the denser material of the artificial heart valve 4702. In this case, because more radial force is applied to the denser parts of the artificial heart valve 4702 through the first longitudinal portion 3675A of the folding element 3114, the uneven radial compression results in a substantially uniform profile of the implantable medical device in the compressed state. The second longitudinal portion 3675B of the folding element 3114 applies less radial force to the less dense or vulnerable parts of the artificial heart valve 4702 to avoid damage. Once crimped via uneven radial compression applied by crimping element 3114, the crimped profile of the implantable medical device is more uniform or consistent along its length compared to the profile achieved by uniform radial compression. In this embodiment, the third longitudinal portion 4075C of crimping element 4014 is configured to apply a higher radial force at the outflow end of artificial heart valve 4702 to facilitate retention of the outflow end of artificial heart valve 4702 on the delivery system.

[0338] Figures 35A to 35B Different views of the folding element 4214, which can be used in folding device 3100 or other folding devices described herein, according to another embodiment of this document, are shown. Those skilled in the art will recognize that... Figures 35A to 35B An example of a folding element is shown, and Figures 35A to 35BThe existing components shown can be removed and / or additional components can be added to the folding element 4214. Although only one folding element 4214 is described in detail, those skilled in the art will recognize that the construction of all folding elements 4214 of the folding device 3100 and the components they include are similar to... Figures 35A to 35B The pressure-bending element 4214 described herein is the same.

[0339] Similar to the folding element 3114, each folding element 4214 has a first leg 4235A, a second leg 4235B, and a folding convex angle 4237 connected to and extending between the first leg 4235A and the second leg 4235B. The first leg 4235A and the second leg 4235B extend parallel to the long axis of the folding element 4214 from the proximal end 4239 of the folding element 4214 to the folding convex angle 4237. The folding convex angle 4237 extends from the first leg 4235A and the second leg 4235B to the distal end 4243 of the folding element 4214. The folding convex angle 4237 defines a folding space 4245, or in other words, includes the folding space 4245 defined therein. The folding space 4245 is configured to receive or accommodate adjacent or neighboring folding elements 4214 when the folding presser 3100 is operated and the size or volume of the folding chamber 4216 decreases. More specifically, the folding element 4214 includes a first side or outer surface 4247 and a second side or inner surface 4249 formed on its opposite side. When assembled into the folding presser 3100, the outer surface 4247 of the folding element 4214 is positioned adjacent to the inner surface 4249 of a neighboring folding element, such that the folding element 4214 is received in the folding space 4245 of the neighboring folding element. Along the outer surface 4247 of the folding convex angle 4237, the folding convex angle 4237 includes a first outer ramp 4257A and a second outer ramp 4257B. The first outer ramp 4257A and the second outer ramp 4257B are inclined surfaces relative to the long axis of the folding element 4214. Along the inner surface 4249 of the folding protrusion 4237, the folding protrusion 4237 includes a first inner slope 4259A and a second inner slope 4259B. The first inner slope 4259A and the second inner slope 4259B define a folding space 4245 and are thus configured to contact an adjacent folding element to produce an iris effect upon displacement of the folding element. The first inner slope 4259A and the second inner slope 4259B are inclined surfaces relative to the long axis of the folding element 4214.

[0340] Similar to the folding element 3114, the folding element 4214 is also configured to apply uneven radial compression along the length of the implantable medical device. More specifically, during operation of the folding device 3100, at least a portion of the second outer ramp 4257B of the folding element 4214 contacts the implantable medical device disposed within the folding chamber 4216. The second outer ramp 4257B is a non-planar surface that applies uneven radial compression along the length of the implantable medical device. Figures 35A to 35B In this embodiment, the second outer ramp 4257B includes three longitudinal portions disposed at different radial positions within the compression chamber 4216, specifically a first longitudinal portion 4275A, a second longitudinal portion 4275B, and a third longitudinal portion 4275C. The second longitudinal portion 4275B is disposed between the first longitudinal portion 4275A and the third longitudinal portion 4275C. The second outer ramp 4257B includes a ridge 4273 formed thereon, bridging or extending between the first longitudinal portion 4275A and the second longitudinal portion 4275B. The ridge 4273 is a curved surface extending between the first longitudinal portion 4275A and the second longitudinal portion 4275B, such that the corresponding longitudinal portions are disposed at different radial positions within the compression chamber 4216. In this embodiment, the third longitudinal portion 4275C gradually tapers towards the second longitudinal portion 4275B along its length.

[0341] Figure 36A and Figure 36B An end view and a side view of a folding chamber 4216 formed by a folding element 4214 are depicted. At the first end of the folding chamber 4216, the folding chamber 4216 has a first diameter D formed by a first longitudinal portion 4275A of the folding element 4214. A Similarly, at the second end of the folding chamber 4216, the folding chamber 4216 also has a diameter D formed by the third longitudinal portion 4275C of the folding element 4214. A Along the second longitudinal portion 4275B, the folding chamber 4216 has a second diameter D formed by the second longitudinal portion 4275B of the folding element 4214. B Because the radial positions of the first longitudinal portion 4275A, the second longitudinal portion 4275B, and the third longitudinal portion 4275C are different, the first diameter D... A Smaller than the second diameter D BBecause the second longitudinal portion 4275B of the flexure element 4214 is positioned further away from the centerline or longitudinal axis of the flexure chamber 4216 than the first longitudinal portion 4275A and the third longitudinal portion 4275C of the flexure element 4214, the diameter of the flexure chamber 4216 increases along the second longitudinal portion 4275B. Conversely, because the first longitudinal portion 4275A and the third longitudinal portion 4275C of the flexure element 4214 are positioned closer to the centerline or longitudinal axis of the flexure chamber 4216 than the second longitudinal portion 4275B of the flexure element 4214, the diameter of the flexure chamber 4216 decreases along the first longitudinal portion 4275A and the third longitudinal portion 4275C. Compared to the radial force applied to the implantable medical device along the second longitudinal portion 4275B of the flexure element 4214, the smaller diameter (i.e., the first diameter D) results in a smaller diameter. A This results in a higher or greater radial force being applied to the implantable medical device along the first longitudinal portion 4275A and the third longitudinal portion 4275C of the compression element 4214. In this embodiment, along the third longitudinal section 4275C, the diameter of the compression chamber 4216 extends from the first diameter D at the end of the compression chamber 4216. A The diameter D gradually decreases to the second diameter D at the intersection point between the first longitudinal segment 4275A and the second longitudinal segment 4275B. B .

[0342] exist Figures 35A to 35B In one embodiment, the first longitudinal portion 4275A is the longest longitudinal portion and extends to between 55% and 65% of the total length of the compression chamber 4216. The second longitudinal portion 4275B extends to between 25% and 35% of the total length of the compression chamber 4216, and the third longitudinal portion 4275C extends to between 5% and 15% of the total length of the compression chamber 4216. (See reference...) Figure 40A The first longitudinal portion 4275A is configured to contact nodes 4785 at the L0, L1, L2, and L3 levels of the artificial heart valve 4702. The second longitudinal portion 4275B is configured to contact node 4785 at the L4 level of the artificial heart valve 4702, and the third longitudinal portion 4275C is configured to contact node 4785 at the L5 level of the artificial heart valve 4702.

[0343] In the described embodiment, the first longitudinal portion 4275A and the third longitudinal portion 4275C are each positioned closer to the centerline or longitudinal axis of the compression chamber 4216 than the second longitudinal portion 3675B. Due to the different radial positions, the first longitudinal portion 4275A and the third longitudinal portion 4275C are configured to apply more radial force to the implantable medical device during compression compared to the second longitudinal portion 4275B. Therefore, when used with the artificial heart valve 4702, more radial force is applied to the nodes 4785 at the L0 level, L1 level, L2 level, L3 level, and L5 level via the first longitudinal portion 4075A and the third longitudinal portion 4075C, while less radial force is applied to the node 4785 at the L4 level of the artificial heart valve 4702. It is desirable to apply less radial force to the L4-level node 4785 of the artificial heart valve 4702 because the L4-level node 4785 is adjacent to the terminal outflow side opening 4789B, which has a lower density compared to other parts of the artificial heart valve 4702 and does not require as much radial force to achieve the desired fold profile. More specifically, the first longitudinal portion 4275A of the folding element 4214 is configured to apply higher radial force along sections of denser material (such as the valve portion of the implantable medical device). In this case, because more radial force is applied to the denser portion of the artificial heart valve 4702 through the first longitudinal portion 4275A of the folding element 4214, the uneven radial compression results in a substantially uniform profile of the implantable medical device in the compressed state. The second longitudinal portion 4275B of the folding element 4214 applies less radial force to the less dense or vulnerable portions of the artificial heart valve 4702 to avoid damage. Once folded by non-uniform radial compression applied through the folding element 4214, the folded profile of the implantable medical device is more uniform or consistent along its length compared to the profile achieved by uniform radial compression. In this embodiment, the third longitudinal portion 4275C of the folding element 4214 is configured to apply a higher radial force to the outflow end of the artificial heart valve 4702 to facilitate retention of the outflow end of the artificial heart valve 4702 on the delivery system. Because the diameter gradually decreases along the third longitudinal segment 4275C of the folding element 4214, the profile of the outflow end of the implantable medical device is tapered.

[0344] Figures 37A to 37B Different views of the folding element 4414, which can be used in folding device 3100 or other folding devices described herein, according to another embodiment of this document, are shown. Those skilled in the art will recognize that... Figures 37A to 37B An example of a folded element is shown, and Figures 37A to 37BThe existing components shown can be removed and / or additional components can be added to the folding element 4414. Although only one folding element 4414 is described in detail, those skilled in the art will recognize that the construction of all folding elements 4414 of the folder 4400 and the components they include are similar to those of other folding elements 4414. Figures 37A to 37B The pressure-bending element 4414 described herein is the same.

[0345] Similar to the folding element 3114, each folding element 4414 has a first leg 4435A, a second leg 4435B, and a folding convex angle 4437 connected to and extending between the first leg 4435A and the second leg 4435B. The first leg 4435A and the second leg 4435B extend parallel to the long axis of the folding element 4414 from the proximal end 4439 of the folding element 4414 to the folding convex angle 4437. The folding convex angle 4437 extends from the first leg 4435A and the second leg 4435B to the distal end 4443 of the folding element 4414. The folding convex angle 4437 defines a folding space 4445, or in other words, includes the folding space 4445 defined therein. The folding space 4445 is configured to receive or accommodate adjacent or neighboring folding elements 4414 when the folding presser 4400 is operated and the size or volume of the folding chamber 4416 decreases. More specifically, the folding element 4414 includes a first side or outer surface 4447 and a second side or inner surface 4449 formed on its opposite side. When assembled into the folding presser 4400, the outer surface 4447 of the folding element 4414 is positioned adjacent to the inner surface 4449 of a neighboring folding element, such that the folding element 4414 is received in the folding space 4445 of the neighboring folding element. Along the outer surface 4447 of the folding convex angle 4437, the folding convex angle 4437 includes a first outer ramp 4457A and a second outer ramp 4457B. The first outer ramp 4457A and the second outer ramp 4457B are inclined surfaces relative to the long axis of the folding element 4414. Along the inner surface 4449 of the folding protrusion 4437, the folding protrusion 4437 includes a first inner slope 4459A and a second inner slope 4459B. The first inner slope 4459A and the second inner slope 4459B define a folding space 4445 and are thus configured to contact an adjacent folding element to produce an iris effect upon displacement of the folding element. The first inner slope 4459A and the second inner slope 4459B are inclined surfaces relative to the long axis of the folding element 4414.

[0346] Similar to the folding element 3114, the folding element 4414 is also configured to apply uneven radial compression along the length of the implantable medical device. More specifically, during operation of the folding device 3100, at least a portion of the second outer ramp 4457B of the folding element 4414 contacts the implantable medical device disposed within the folding chamber 4416. The second outer ramp 4457B is a non-planar surface that applies uneven radial compression along the length of the implantable medical device. Figures 37A to 37B In one embodiment, the second outer ramp 4457B includes four longitudinal portions disposed at different radial positions within the folding chamber 4416, specifically a first longitudinal portion 4475A, a second longitudinal portion 4475B, a third longitudinal portion 4475C, and a fourth longitudinal portion 4475D. The second longitudinal portion 4475B is disposed between the first longitudinal portion 4475A and the third longitudinal portion 4475C. The third longitudinal portion 4475C is disposed between the second longitudinal portion 4475B and the fourth longitudinal portion 4475D. The second outer ramp 4457B includes a ridge 4473 formed thereon that bridges or extends between the second longitudinal portion 4475B and the third longitudinal portion 4475C. The ridge 4473 is a curved surface extending between the second longitudinal portion 4475B and the third longitudinal portion 4475C, such that the corresponding longitudinal portions are disposed at different radial positions within the folding chamber 4416. In this embodiment, the first longitudinal portion 4475A gradually tapers along its length toward the second longitudinal portion 4275B, and the fourth longitudinal portion 4475D gradually tapers along its length toward the third longitudinal portion 4275C.

[0347] Figure 38A and Figure 38B An end view and a side view of a folding chamber 4416 formed by a folding element 4414 are depicted. At the first end of the folding chamber 4416, the folding chamber 4416 has a first diameter D formed by a first longitudinal portion 4475A of the folding element 4414. A Similarly, at the second end of the folding chamber 4416, the folding chamber 4416 also has a diameter D formed by the fourth longitudinal portion 4475D of the folding element 4414. A Along the second longitudinal portion 4475B, the folding chamber 4416 has a second diameter D formed by the second longitudinal portion 4475B of the folding element 4414. B Similarly, along the third longitudinal portion 4475C, the folding chamber 4416 has a third diameter D formed by the third longitudinal portion 4475C of the folding element 4414. C Because the radial positions of the first longitudinal portion 4475A, the second longitudinal portion 4475B, the third longitudinal portion 4475C, and the fourth longitudinal portion 4475D are different, the first diameter D... A Smaller than the second diameter DB and the third diameter D C The diameters within. Furthermore, since the radial positions of the second longitudinal portion 4475B and the third longitudinal portion 4475C are different, the second diameter D... B Smaller than the third diameter D C Because the third longitudinal portion 4475C of the folding element 4414 is positioned furthest from the centerline or longitudinal axis of the folding chamber 4416, the diameter of the folding chamber 4416 is largest along the third longitudinal portion 4475C. Conversely, because the first longitudinal portions 4475A and the fourth longitudinal portions 4475D of the folding element 4414 are positioned closest to the centerline or longitudinal axis of the folding chamber 4416, the diameter of the folding chamber 4416 is smallest along the first longitudinal portions 4475A and the fourth longitudinal portions 4475D. The smallest diameter (i.e., the first diameter D) is smaller compared to the radial force applied to the implantable medical device along the second longitudinal portions 4475B and the third longitudinal portions 4475C of the folding element 4414. A This results in the highest or maximum radial force applied to the implantable medical device along the first longitudinal portion 4475A and the fourth longitudinal portion 4475D of the compression element 4414. In this embodiment, along the first longitudinal section 4475A, the diameter of the compression chamber 4416 extends from the first diameter D at the end of the compression chamber 4416. A The diameter D gradually decreases to the second diameter D at the intersection point between the first longitudinal segment 4475A and the second longitudinal segment 4475B. B Furthermore, in this embodiment, along the fourth longitudinal section 4475D, the diameter of the compression chamber 4416 extends from the first diameter D at the end of the compression chamber 4416. A The diameter gradually decreases to the third diameter D at the intersection point between the fourth longitudinal segment 4475D and the third longitudinal segment 4475C. C .

[0348] exist Figures 37A to 37B In one embodiment, the second longitudinal portion 4475B is the longest longitudinal portion and extends to between 50% and 60% of the total length of the folding chamber 4416. The first longitudinal portion 4475 extends to between 2% and 8% of the total length of the folding chamber 4416, the third longitudinal portion 4475C extends to between 25% and 35% of the total length of the folding chamber 4416, and the fourth longitudinal portion 4475D extends to between 5% and 15% of the total length of the folding chamber 4416. (See reference...) Figure 40AThe first longitudinal portion 4475A is configured to contact node 4785 at the L0 level of the artificial heart valve 4702, while the second longitudinal portion 4475B is configured to contact nodes 4785 at the L1, L2, and L3 levels of the artificial heart valve 4702. The third longitudinal portion 4475C is configured to contact node 4785 at the L4 level of the artificial heart valve 4702, and the fourth longitudinal portion 4475D is configured to contact node 4785 at the L5 level of the artificial heart valve 4702.

[0349] The first longitudinal portion 4475A and the fourth longitudinal portion 4475D are each configured to be closer to the centerline or longitudinal axis of the compression chamber 4416 than the second longitudinal portion 4475B and the third longitudinal portion 4475C. Further, the second longitudinal portion 4475B is configured to be closer to the centerline or longitudinal axis of the compression chamber 4416 than the third longitudinal portion 4475C. Due to the different radial positions, the first longitudinal portion 4475A and the fourth longitudinal portion 4475D are configured to apply more radial force to the implanted medical device during compression compared to the second longitudinal portion 4475B and the third longitudinal portion 4475C. Furthermore, the second longitudinal portion 4475B is configured to apply more radial force to the implanted medical device during compression compared to the third longitudinal portion 4475C. Therefore, when used with the artificial heart valve 4702, the maximum radial force is applied to the L0 level node 4785 at the inflow end of the artificial heart valve 4702 and the L5 level node 4785 at the outflow end of the artificial heart valve 4702. Similarly, relatively more radial force is applied to the L1 level node 4785, L2 level node 4785, and L3 level node 4785 via the second longitudinal portion 4475B, while less radial force is applied to the L4 level node 4785 of the artificial heart valve 4702 via the third longitudinal portion 4475C. It is desirable to apply less radial force to the L4 level node 4785 of the artificial heart valve 4702 because the L4 level node 4785 is adjacent to the terminal outflow side opening 4789B, which has a lower density compared to other parts of the artificial heart valve 4702 and does not require as much radial force to be applied to achieve the desired fold profile. More specifically, compared to the third longitudinal portion 4475C of the compression element 4414, the second longitudinal portion 4475B of the compression element 4414 is configured to apply a higher radial force along a section of the denser material of the artificial heart valve 4702. In this case, because more radial force is applied to the denser portion of the artificial heart valve 4702 by the second longitudinal portion 4475B of the compression element 4414, the uneven radial compression results in a substantially uniform profile of the implantable medical device in the compressed state. The third longitudinal portion 4475C of the compression element 4414 applies less radial force to the less dense or vulnerable portions of the artificial heart valve 4702 to avoid damage. Once compression is achieved via uneven radial compression applied by the compression element 4414, the compression profile of the implantable medical device is more uniform or more consistent along its length compared to the profile achieved by uniform radial compression.In this embodiment, the first longitudinal portion 4475A and the fourth longitudinal portion 4475D of the compression element 4414 are each configured to apply high radial forces to the inflow and outflow ends of the artificial heart valve 4702, respectively, to facilitate retention of the outflow end of the artificial heart valve 4702 on the delivery system. Because the diameters of the first longitudinal segment 4475A and the fourth longitudinal segment 4475D of the compression element 4414 gradually decrease, the inflow and outflow ends of the implantable medical device have tapered profiles.

[0350] Figures 39A to 39D An example of the operation of a pleater 3100 according to one embodiment of this document is shown. Those skilled in the art will recognize... Figures 39A to 39D Only a few operating states are shown to illustrate the operation of the folding press 3100, and it will be appreciated that the folding press 3100 can take on other operating states without departing from the scope of the invention.

[0351] like Figure 39A and Figure 39B As shown, the implantable medical device 4602 and delivery device 4604 are fitted or placed into the folding chamber 3116 of the folding device housing 3104. As described above, the folding element 3114 forms the folding chamber 3116. Figures 39C to 39D As shown, to compress the implantable medical device 4602, a force is applied to the handle 3102 in a clockwise direction in the direction of the base 3106. The force applied to the handle 3102 is transmitted to the cam 3110 via the gear 3112, and the cam 3110 rotates in the opposite direction to the handle 3102 (i.e., counterclockwise). The rotation of the cam 3110 causes the pressure element 3112 to move radially inward via the lever 3118. More specifically, as described above, as the handle 3102 moves, the cam 3110 rotates and converts or converts the rotational motion of the handle 3102 into linear motion of the pressure element 3114 via the lever 3118.

[0352] As the folding element 3114 moves radially inward, the space available for the folding element 3114 to occupy decreases. Therefore, the volume of the folding chamber 3116 decreases, and the folding element 3114 applies a compressive force to the outer surface of the implantable medical device 4602 to fold the implantable medical device 4602 from an uncompressed or radially expanded state into a radially compressed state. For example, if the shape of the implantable medical device 4602 is generally circular or cylindrical, when force is applied to the handle 3102, the folding element applies force from multiple different directions on the surface of the implantable medical device, thereby compressing the implantable medical device.

[0353] like Figure 39CAs shown, the handle 3102 can be moved downwards until it abuts against the first stop 3150, thereby partially compressing the implantable medical device 4602 to a predetermined diameter. If only partial compression of the implantable medical device 4602 is required, the handle 3102 can be moved upwards and the implantable medical device 4602 can be removed from the compression chamber 3116.

[0354] To fully compress the implantable medical device 4602, remove the first stop 3150 from the compressor 3104 and further actuate or move the handle 3102 until the handle 3102 is adjacent to the second stop 3152, as shown. Figure 39D As shown. Further movement of the handle 3102 results in additional radial compression of the implantable medical device 4602.

[0355] The compression folding element 3114 is configured to apply uneven radial compression along the length of the implantable medical device. As described above, the second longitudinal portion 3675B of the compression folding element 3114 is configured to apply more radial force to the implantable medical device during compression compared to the first longitudinal portion 3675A of the compression folding element 3114. In embodiments where the implantable medical device 4602 includes a valve disposed thereon, the second longitudinal portion 3675B of the compression folding element 3114 is configured to be disposed on the first portion of the implantable medical device 4602 including the valve, while the first longitudinal portion 3675A of the compression folding element 3114 is configured to be disposed on the second portion of the implantable medical device 4602 excluding the valve. In this embodiment, because more radial force is applied to the denser portion of the implantable medical device through the second longitudinal portion 3675B of the compression folding element 3114, the uneven radial compression results in the implantable medical device having a substantially uniform profile in the compressed state. The first longitudinal portion 3675A of the crimping element 3114 applies less radial force to the less dense or vulnerable parts of the implantable medical device to avoid damage. Once crimped by uneven radial compression applied through the crimping element 3114, the crimped profile of the implantable medical device is more uniform or consistent along its length compared to the profile achieved by uniform radial compression.

[0356] In another embodiment of this document, the implantable medical device 4602 does not include a valve and its density is substantially uniform along its length. In this embodiment, the folding profile of the implantable medical device 4602 is stepped, such that the folding diameter of its first longitudinal portion (folded through the second longitudinal portion 3675B) is smaller than that of its second longitudinal portion (folded through the first longitudinal portion 3675A).

[0357] The folding device 3100 can be used for any type of implantable medical device that requires conversion from an uncompressed state to a compressed state. In embodiments, the folding device can be applied to any implantable medical device that requires on-site folding of the medical device to be implanted onto a catheter, such as organic tissue containing a valve repair device. In embodiments, the folding device 3100 can be used with balloon-expandable medical devices and / or mechanically expandable medical devices. For example, the folding device 3100 can be used for implantable medical devices that require transluminal delivery, for example, via a catheter and need to be fitted onto or into a catheter. In this example, the implantable medical device may include a heart valve prosthesis comprising a stent or frame and an artificial valve attached within the frame. The stent / frame can be folded to have a small profile, allowing the prosthesis to be delivered in a compressed state through a blood vessel to a target location, and then (e.g., via a balloon of the delivery device) expanded at the target location to replace the native heart valve.

[0358] Figure 40A and Figure 40B An exemplary implantable medical device including a valve disposed therein is shown for use with a folding device 3100. Figure 40A and Figure 40B An artificial heart valve 4702 is shown, having a radially expandable stent 4791 and an artificial valve 4793. The artificial heart valve 4702 is merely exemplary, and it will be apparent to those skilled in the art that the folding device 3100 can be used with any type of radially compressible implantable medical device. The artificial heart valve 4702 is described more fully in U.S. Patent Application No. 17 / 186,485, filed February 26, 2021, which is incorporated herein by reference in its entirety. The stent 4791 of the artificial heart valve 4702 is an integral frame or stent supporting the artificial valve 4793, which includes one or more leaflets located within the stent 4791. The artificial valve 4793 is capable of blocking flow in one direction to regulate the flow through the artificial valve via the leaflets, which can form a mitral or tricuspid valve replacement valve. The support 4791 includes an inflow portion 4795A, an outflow portion 4795C, and a transition portion 4795B that bridges, connects, or otherwise extends between the inflow portion 4795A and the outflow portion 4795C.

[0359] The inflow portion 4795A includes a plurality of crowns 4797A and a plurality of struts 4799A, each crown 4797A being formed between a pair of opposing struts 4799A. Each crown 4797A is a curved segment or bend extending between the opposing struts 4799A. The inflow portion 4795A is tubular and has a plurality of side openings 4789A defined by the plurality of crowns 4797A and the plurality of struts 4799A. In an embodiment, the plurality of side openings 4789A may be rhomboid.

[0360] The outflow portion 4795C includes multiple crowns 4797C and multiple struts 4799C, each crown 4797C being formed between a pair of opposing struts 4799C. Each crown 4797C is a curved segment or bend extending between the opposing struts 4799C. The outflow portion 4795C can be configured to form a shape that creates a central cavity or channel, for example, an annulus.

[0361] The three leaflets of the artificial valve 4793 are attached to the stent 4791 along the attachment margin located after the strut 4799A and node 4785 of the inflow portion 4795A. Node 4785 is defined as the region where two of the multiple coronals 4797A within the inflow portion 4795A connect, or the region where two of the multiple coronals 4797C within the outflow portion 4795C connect. For example... Figure 40A As shown, the artificial heart valve 4702 includes five horizontal nodes: node 4785 at the L0 level located at the inflow end of the artificial valve device 4702, node 4785 at the L1 level directly adjacent to the L0 level, node 4785 at the L2 level directly adjacent to the L1 level, node 4785 at the L3 level directly adjacent to the L2 level, node 4785 at the L4 level directly adjacent to the L3 level, and node 4785 at the L5 level located at the outflow end of the artificial valve device 4702.

[0362] The transition portion 4795B bridges, connects, or otherwise extends between the inflow portion 4795A and the outflow portion 4795C. The transition portion 4795B includes a total of six axial frame members 4787, each extending between the coronal portion 4797C of the outflow portion 4795C and the coronal portion 4797A of the inflow portion 4795A. The axial frame members 4787 are substantially parallel to the central longitudinal axis of the stent 4791. Three of the six axial frame members 4787 are syndesms and are aligned and attached to the corresponding syndesms of the three leaflets of the artificial valve 4793. Three of the axial frame members 4787 are axial struts and are positioned between adjacent syndesms.

[0363] The stent 4791 includes multiple terminal outflow side openings or units 4789B. The terminal outflow side openings 4789B of the outflow portion 4795C are relatively larger than the multiple side openings 4789A of the inflow portion 4795A to improve coronary artery access. More specifically, the terminal outflow side openings 4789B of the outflow portion 4795C are configured to be large enough to easily pass through the coronary guiding catheter into the right coronary artery or left main coronary artery after the artificial heart valve 4702 has deployed in situ.

[0364] Although this document describes the case for folding device 3100, it will be apparent to those skilled in the art that the non-planar surfaces of folding elements 3114, 3814, 4014, 4214, 4414 can be incorporated into the folding elements of folding devices 800, 1500, 1900, 2600 described herein to apply non-uniform radial compression to an implantable medical device.

[0365] It should be understood that the various embodiments disclosed herein can be combined into combinations different from those specifically presented in the specification and drawings. It should also be understood that, based on examples, certain actions or events of any process or method described herein may be performed in a different order, and may be added, combined, or omitted entirely (e.g., not all described actions or events may be necessary for implementing these techniques). Furthermore, although some aspects of this disclosure are described for clarity as being performed by a single device or component, it should be understood that the techniques disclosed herein can be performed by a combination of devices or components associated with, for example, a medical device.

Claims

1. A flip-type compression device for changing an implantable medical device from an uncompressed state to a compressed state, the compression device comprising: A top housing, the top housing including a top cam, a top pressing element housing and a plurality of first pressing elements defining a top groove; A base housing, the base housing including a base cam, a base pressing element housing, and a plurality of second pressing elements, the plurality of second pressing elements defining a bottom groove, wherein: The top housing and the base housing are connected at a pivot connection. The top housing is configured to rotate from an open state to a closed state relative to the base housing around the pivot connection. When in the open state, the bottom groove is exposed to allow insertion of the implantable medical device, and When in the closed state, the top groove and the bottom groove define a compression chamber; A handle configured to operate the flap folder and at least connected to a top cam of the top housing; When in the closed state, movement of the handle causes the top cam and the base cam to rotate, thereby displacing the plurality of first and second pressure-bending elements, and The displacement of the plurality of first folding elements and the plurality of second folding elements reduces the volume of the folding chamber, thereby changing the implantable medical device from the uncompressed state to the compressed state.

2. The flip-top folding device as described in claim 1, wherein, The plurality of first folding elements are movably connected within the top folding element housing and the base folding element housing.

3. The flip-top folding device as described in claim 1, wherein, The plurality of first pressing elements or the plurality of second pressing elements include: A folding convex angle, wherein the surface of the folding convex angle forms part of the folding chamber. The folding device body connected to the folding convex angle, and At least one pin is connected to the folding element body, wherein the at least one pin is configured to movably connect the folding element to one of the top cam and the base cam.

4. The flip-top folding device as described in claim 3, wherein, The folding convex angle includes a folding space defined by one or more ramps, and Wherein, at least one of the one or more slopes is in contact with an adjacent folding convex angle of an adjacent folding element among the plurality of first folding elements or the plurality of second folding elements.

5. The flip-top folding device as described in claim 4, wherein, At least one of the top cam and the base cam includes: At least one pin groove is formed within the surface of the top cam or the base cam, wherein the pin groove is configured to receive the at least one pin of the pressing element.

6. The flip-top folding device as described in claim 5, wherein, The at least one pin groove includes a plurality of pin grooves formed in a spiral pattern.

7. A flip-type compression device for changing an implantable medical device from an uncompressed state to a compressed state, the compression device comprising: A top iris housing, the top iris housing including a plurality of first folding elements defining a top iris groove; A base iris shell, connected to the top iris shell at a pivot connection, the base iris shell including a plurality of second folding elements defining a base iris groove, wherein: The top iris housing is configured to rotate from an open state to a closed state relative to the base iris housing around the pivot connection. When in the open state, the basal iris groove is exposed for insertion of the implantable medical device, and When in the closed state, the top iris groove and the base iris groove define a folding chamber; and A handle configured to operate the flip-top folding device, wherein actuation of the handle reduces the volume of the folding chamber to change the implantable medical device from the uncompressed state to the compressed state.

8. The flip-top folding device as described in claim 7, wherein, The plurality of first pressing elements or the plurality of second pressing elements include: A folding convex angle, wherein the surface of the folding convex angle forms part of the folding chamber. The folding device body connected to the folding convex angle, and At least one pin connected to the folding element body, wherein the at least one pin is configured to movably connect the folding element to one of at least one cam of the top iris housing and at least one cam of the base iris housing.

9. The flip-top folding device as described in claim 8, wherein, The folding convex angle includes a folding space defined by one or more ramps, and Wherein, at least one of the one or more slopes is in contact with an adjacent folding convex angle of an adjacent folding element among the plurality of first folding elements or the plurality of second folding elements.

10. A method for changing an implantable medical device from an uncompressed state to a compressed state, the method comprising: The implantable medical device is fitted into the folding chamber of the folding device according to any one of claims 1 to 9, wherein the folding chamber is defined by a plurality of folding elements, each of the folding elements including a non-planar surface forming a portion of a folding groove; and The handle of the flip-type folding device is actuated to operate the flip-type folding device, wherein actuation of the handle reduces the volume of the folding chamber to change the implantable medical device from the uncompressed state to the compressed state, and wherein each of the non-planar surfaces applies uneven radial compression along the length of the implantable medical device during operation of the folding device.

11. The method of claim 10, wherein, A first radial force is applied to a first segment of the implantable medical device through a first longitudinal portion of the non-planar surface, and a second radial force is applied to a second segment of the implantable medical device through a second longitudinal portion of the non-planar surface, wherein the second radial force is greater than the first radial force.

12. The method of claim 11, wherein, The second segment of the implantable medical device is denser than the first segment of the implantable medical device.

13. The method of claim 12, wherein, The second segment of the implantable medical device includes a valve.

14. The method of claim 12, wherein, The first segment of the implantable medical device includes a plurality of openings formed in a stent of the implantable medical device, the plurality of openings being configured to provide coronary artery access when implanted in situ.

15. The method of claim 12, wherein, The implantable medical device has a substantially uniform profile in the compressed state.

16. The method of claim 11, wherein, The second section of the implantable medical device is one of the inflow end and the outflow end of the implantable medical device.

17. The method of claim 10, wherein, The non-planar surface includes a first longitudinal portion and a second longitudinal portion, the second longitudinal portion being configured to be closer to the centerline of the compression chamber than the first longitudinal portion, such that the second longitudinal portion is configured to apply a higher radial force to the implantable medical device compared to the first longitudinal portion.

18. The method of claim 17, wherein, The first longitudinal portion extends between 35% and 45% of the total length of the folding chamber, and the second longitudinal portion extends between 55% and 65% of the total length of the folding chamber.

19. The method of claim 10, wherein, The non-planar surface includes a first longitudinal portion, a second longitudinal portion, and a third longitudinal portion, the second longitudinal portion being disposed between the first longitudinal portion and the third longitudinal portion. The first longitudinal portion and the third longitudinal portion are configured to be closer to the centerline of the compression chamber than the second longitudinal portion, such that the first longitudinal portion and the third longitudinal portion are configured to apply a higher radial force to the implantable medical device compared to the second longitudinal portion.

20. The method of claim 10, wherein, The non-planar surface includes a first longitudinal portion, a second longitudinal portion, a third longitudinal portion, and a fourth longitudinal portion. The second longitudinal portion is disposed between the first longitudinal portion and the third longitudinal portion, and the third longitudinal portion is disposed between the second longitudinal portion and the fourth longitudinal portion. The first longitudinal portion and the fourth longitudinal portion are configured to be closer to the centerline of the compression chamber than each of the second longitudinal portion and the third longitudinal portion, such that the first longitudinal portion and the fourth longitudinal portion are configured to apply a higher radial force to the implantable medical device compared to each of the second longitudinal portion and the third longitudinal portion. The second longitudinal portion is configured to be closer to the centerline of the compression chamber than the third longitudinal portion, such that the second longitudinal portion is configured to apply a higher radial force to the implantable medical device compared to the third longitudinal portion.

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