Stent graft crimping device and method of use

Abstract

This invention provides a stent graft crimping device for radially shrinking a stent graft. [Solution] The stent graft crimping device 10 includes a rigid cylinder 12 that defines a slot 20 extending parallel to the longitudinal axis 22 of a flexible sheet 24 having a straight edge 26 and a second edge 30, which extends into the rigid cylinder 12 to define a pocket 32. In use, the stent graft may be placed in the pocket while the straight edge having a raised component 28 remains in the slot defined by the rigid cylinder, and may be radially contracted by pulling the second edge of the flexible sheet. The stent graft crimping device may be used independently or as a system in combination with components of a stent graft delivery device.

Description

Technical Field

[0001] Cross - reference to related applications This application claims the benefit of U.S. Provisional Patent Application No. 63 / 290,344, filed on December 16, 2021, the entire content of which is incorporated herein by reference.

Background Art

[0002] Background of the Invention Demonstration of a stent graft delivery device typically requires the release of a radially - collapsed or "crimped" stent graft previously loaded within one or more delivery sheaths or "introducer" sheaths. Most stent grafts delivered by such devices are self - expanding and often include a plurality of radially self - expanding stents made of an alloy or a shape - memory alloy. Once deployed in the course of demonstrating a surgical delivery device in which the stents are bundled together during assembly and fabrication, self - expanding stent grafts are typically very difficult to reload by hand. Known devices for loading a surgical stent graft prosthesis into a surgical delivery device, such as an "iris crimper", are complex, heavy, expensive, and too large for transport by sales and marketing responsible staff at locations remote from their manufacturing sites.

[0003]

[0004] Therefore, there is a need for devices, systems, and methods for loading stent grafts into surgical delivery devices in the field.

Summary of the Invention

[0005] Summary of the Invention The present invention generally relates to stent graft crimping devices and systems for radially shrinking stent grafts, and to methods for loading stent grafts into stent graft delivery devices.

[0006] In one embodiment, the present invention is a stent graft crimping device for radially shrinking a stent graft comprising a rigid cylinder and a flexible sheet. The rigid cylinder has an outer surface and an inner surface and defines a lumen and slot extending parallel to the longitudinal axis of the rigid cylinder. The flexible sheet has a straight edge, a raised component at the straight edge and a second edge opposite the straight edge. The straight edge is adjacent to the longitudinal slot on the outer surface of the rigid cylinder. The flexible sheet extends from the straight edge through the slot into the lumen of the rigid cylinder, and from the lumen through the longitudinal slot to the second edge of the outer surface of the rigid cylinder. This defines a pocket for the flexible sheet within the lumen of the rigid cylinder.

[0007] In another embodiment, the present invention is a stent graft loading system comprising a rigid cylinder, a flexible sheet, a guidewire catheter, an apical clasp component, and an apical clasp catheter. The rigid cylinder has an outer surface and an inner surface and defines a lumen and slot extending parallel to the longitudinal axis of the rigid cylinder. The flexible sheet has a straight edge, a raised component at the straight edge, and a second edge opposite the straight edge. The raised components and straight edges are adjacent to the longitudinal slots on the outer surface of the rigid cylinder. The flexible sheet extends from the straight edges through the slots into the lumen of the rigid cylinder, and from the lumen through the longitudinal slots to the outer surface of the rigid cylinder. It then extends to the second edge, thereby creating a pocket of the flexible sheet within the lumen of the rigid cylinder. The following is defined: The guidewire catheter extends through a pocket and has a distal end and a proximal end. The apical clasp component is fixed to the distal end of the guidewire catheter and includes a proximal clasp component that is matable to the distal clasp component at the distal end of the guidewire catheter and is proximal to the distal clasp component. The apical clasp catheter is fixed to the proximal clasp component of the apical clasp component and extends proximal therefrom.

[0008] In yet another embodiment, the present invention relates to a method for loading a stent graft into a stent graft delivery device, the method comprising loading the stent graft into a pocket defined by a flexible sheet having a straight edge and a second edge opposite the straight edge. The process includes the extension of a straight edge parallel to a slot defined by a rigid cylinder, having an adjacent raised component that extends parallel to the longitudinal axis of the rigid cylinder. The flexible sheet extends from the raised component of the straight edge through the slot into the lumen defined by the rigid cylinder, and from inside the lumen through the slot to the opposite edge of the flexible sheet outside the rigid cylinder, thereby defining a pocket for the flexible sheet. The second edge of the flexible sheet is pulled away from the rigid cylinder, and This reduces the volume of the pocket, causes the stent graft to contract radially, and moves the longitudinal axis of the stent graft away from the longitudinal axis of the rigid cylinder and toward the slot of the rigid cylinder. The stent graft is directed along its longitudinal axis from the pocket to an independent radially contracting member, while remaining radially contracted along its longitudinal axis.

[0009] The present invention has many advantages. For example, the stent graft crimping device of the present invention is easy to use and easily transportable. Furthermore, the stent graft loading system and method for loading a stent graft into the stent graft delivery device of the present invention can be adapted to different types of stent grafts, such as those using longitudinal supports sewn to the basic structure of the stent graft, such as support rods such as longitudinal support rods, and stent grafts using crown stents and clasp stents that must be attached to the apical clasp component of the surgical stent graft delivery device. Also, an external longitudinal support (sport), such as one fixed to the surgical stent graft delivery device, and its other Stent grafts that require a support wire that extends distally along the components and is passed through the suture loop of the stent graft can also be adapted by the stent graft crimping device, system and method of use of the present invention. [Brief explanation of the drawing]

[0010] Brief explanation of the drawing [Figure 1] Figure 1A is a perspective view of a rigid cylinder component of one embodiment of the stent graft crimping device of the present invention. Figure 1B is an end view of the rigid cylinder shown in Figure 1A. [Figure 2] Figure 2A is a plan view of a flexible sheet component of one embodiment of the stent graft crimping device of the present invention. Figure 2B is an end view of the flexible sheet shown in Figure 2A. [Figure 3] Figure 3A is a perspective view of the assembled stent graft crimping device shown in Figures 1A, 1B, 2A, and 2B, before radial contraction of the pocket defined by the flexible sheet of the stent graft crimping device of the present invention. Figure 3B is a terminal view of the stent graft crimping device of the present invention shown in Figure 3A. [Figure 4]Figure 4A is a perspective view of the stent graft crimping device of the present invention shown in Figures 3A and 3B, after radial contraction of the pocket defined by the flexible sheet. Figure 4B is an end-in view of the stent graft crimping device of the present invention shown in Figure 4A. [Figure 5] Figure 5A is a perspective view of the stent graft crimping device shown in Figures 1A-4B, where the stent graft is loaded into a pocket defined by a flexible sheet, before it is radially compressed according to an aspect of the method of the present invention. Figure 5B is a terminal view of the stent graft crimping device and the loaded stent graft prosthesis of Figure 5A. [Figure 6] Figure 6A is a perspective view of the stent graft crimping device shown in Figures 5A and 5B, after radial shrinkage of the stent graft by the method of the present invention. Figure 6B is a terminal view of the stent graft crimping device shown in Figure 6A. [Figure 7] Figure 7 is a perspective exploded view of another embodiment of the stent graft crimping device of the present invention, further including a loading block and a loading tube. [Figure 8] Figure 8 is an assembly diagram of the stent graft crimping device shown in Figure 7. [Figure 9] Figure 9 details another embodiment of the stent graft loading system of the present invention, showing the proximal end of the stent graft being partially withdrawn from a rigid cylinder to attach the clasp stent of the stent graft to the top clasp component of the stent graft loading system, and the suturing of the stent graft to the support wire of the stent graft loading system. [Figure 10] Figure 10 shows one embodiment of the top clasp component of the stent graft loading system shown in Figure 9 in the closed position. [Figure 11] Figure 11 is a perspective view of the loading rod of the stent graft loading system of Figure 9, which can be screw-fixed to a guidewire catheter of a stent graft delivery device suitable for use according to the present invention. [Figure 12] FIG. 12 is a perspective view of a stent graft suitable for use in accordance with the present invention, including a clasp stent having a bare proximal top that can be captured by a crown stent and a top clasp component also shown in FIG. 12. [Figure 13] FIG. 13 is a perspective view of the stent graft of FIG. 12 after capture by the top clasp component. [Figure 14] FIG. 14 is a perspective view of a stent graft including a suture loop through which a wire support of a delivery device suitable for use with the stent graft loading system of the present invention can pass. [Figure 15] FIG. 15 is a perspective view of the stent graft of FIG. 14 with a support wire passed through the suture loop, which is a component of this aspect of the stent graft loading system of the present invention. [Figure 16] FIG. 16 is an end view of a stent graft of the present invention including an S-bar support when loaded into a pocket defined by a flexible sheet of the stent graft crimping device of the present invention. [Figure 17] FIG. 17 is a side view of one aspect of a stent graft delivery device suitable for use with the stent graft crimping device and the stent graft loading system of the present invention. [Figure 18] FIG. 18 is a perspective view of one aspect of a method step of the present invention, including filling a radially contracted stent graft from a rigid cylinder through a loading block into a loading tube of one aspect of the stent graft crimping device of the present invention. [Figure 19] FIG. 19 is a perspective view of one aspect of two further method steps after those shown in FIG. 18, where the loading tube is replaced by a secondary sheath of a stent graft delivery device suitable for use with the stent graft crimping device of the present invention.

BRIEF DESCRIPTION OF THE DRAWINGS

[0011] DETAILED DESCRIPTION OF THE INVENTION The features and other details of the present invention will be more particularly described and pointed out in the claims, either as steps of the present invention or as combinations of parts of the present invention. The specific embodiments of the present invention are shown by way of illustration and not limitation. The main features of the present invention can be used in various embodiments without departing from the scope of the present invention.

[0012] An explanation of the exemplary embodiments is given below.

[0013] The present invention generally relates to a stent graft crimping device and system for radially contracting a stent graft, and a method of loading a stent graft onto a stent graft delivery device.

[0014] When reference is made herein to a large artery prosthesis, such as a "stent graft", "prosthesis", "stent graft prosthesis", "vascular prosthesis" or other prosthesis, to be delivered or implanted in a patient, the word "proximal" means that a part of the prosthesis or a component of the prosthesis is relatively close to the patient's heart, and "distal" means that a part of the prosthesis or a component of the prosthesis is relatively far from the patient's heart.

[0015] However, when reference is made to a delivery system or a component of a delivery system used to deliver or implant a prosthesis, the word "proximal" means closer to the clinician using the delivery system when the word is used herein. When a component of a delivery system is referred to as being "distal" to the delivery system, "distal" means further away from the clinician using the delivery system when the term is used herein.

[0016] For clarity, the word "adjacent" means "close", which is different from the meaning resulting from "proximal" or "distal" as described above with respect to either a prosthesis or a delivery system.

[0017] Figures 1A, 1B, 2A, and 2B show a component of one embodiment of the stent graft crimping device 10 of the present invention for radially shrinking a stent graft. As can be seen in the perspective view of Figure 1A and the end view of Figure 1B along plane B of Figure 1A, the stent graft crimping device The structure 10 includes a rigid cylinder 12 having an outer surface 14 and an inner surface 16, defining a lumen 18 and a slot 20 extending parallel to the longitudinal axis 22 of the rigid cylinder 12. A suitable material example for the structure of the rigid cylinder 12 is clear acrylic resin. The flexible sheet 24 shown in the plan and end view of Figures 2A and 2B, respectively, has a straight edge 26 and a raised component 28 along the straight edge 26 and a second edge 30 opposite the straight edge 26. A suitable material for a flexible sheet structure is a Teflon PTFE film with a thickness ranging from about 0.010 inches to about 0.050 inches, preferably about 0.010 inches or 0.010 inches in its preferred configuration. Yes. The raised components 28 of the flexible sheet 24 protrude from at least one surface of the flexible sheet 24, as can be seen in Figure 2B. Typically, the raised components 28 are nylon 2-part push-in rivets with a snap shank.

[0018] When assembled as shown in Figures 3A and 3B, the raised components 28 of the straight edge 26 and the second edge 30 are parallel to the longitudinal slot 20 on the outer surface 14 of the rigid cylinder 12. Adjacent to it, the flexible sheet 24 extends from the straight edge 26 of the rigid cylinder 12 through the longitudinal slot 20 into the lumen 18, and from the lumen 18 of the rigid cylinder 12 through the longitudinal slot 20 to the second edge 30 on the outer surface 14, thereby providing a flexible sheet within the lumen 18 of the rigid cylinder 12. Define pocket 32 ​​of T24.

[0019] As shown in the transition from Figures 3A and 3B to Figures 4A and 4B, the pocket 32 ​​defined by the flexible sheet 24 is reduced by pulling the second edge 30 in direction A away from the longitudinal slot 20 of the rigid cylinder 12 by hand or the like, thereby reducing the radial diameter R of the pocket 32. The radial diameter R' is reduced. The raised components 28 of the flexible sheet 24 prevent the straight edge 26 from being pulled into the lumen 18 of the rigid cylinder 12, and the friction between the contact surfaces of the flexible sheet 24 in the longitudinal slot 20 as the flexible sheet 24 passes through the longitudinal slot 20 is reduced when it is radially contracted by pulling the second edge 30 of the flexible sheet 24. This may provide some resistance to the expansion of pocket 32.

[0020] Figures 5A and 5B and 6A and 6B show embodiments of the stent graft crimping device of the present invention shown in Figures 1A-4B when loading a radially self-expanding stent graft 34. As can be seen in Figure 5B, the radially self-expanding stent graft 34 is in a relatively relaxed state within a pocket 32 ​​defined by a flexible sheet 24 within the lumen of the rigid cylinder 12 before radial contraction by the method of the present invention. The longitudinal axis 22 of the rigid cylinder 12 and the longitudinal axis 36 of the radially self-expanding stent graft 34 may coincide, as shown in Figure 5B.

[0021] As shown in the transition from Figure 5A to Figure 6A, the second edge 30 of the flexible sheet 24 is made of rigid silicone. As the radially self-expanding prosthesis 34 is pulled away from the longitudinal slot 20 of the cylinder 12, it contracts radially, as shown in the progression from Figure 5B to Figure 6B. When the radially self-expanding stent graft 34 contracts radially, the longitudinal axis 36 of the radially self-expanding stent graft 34 moves away from the longitudinal axis 22 of the rigid cylinder 12. In an example shown in Figures 5A and 5B, where the longitudinal axes 22 and 36 of the rigid cylinder 12 and the radially self-expanding stent graft 34 coincide, the longitudinal axis 36 of the radially self-expanding prosthesis 34 pulls the second edge 30 away from the longitudinal slot 20 of the rigid cylinder 12. During the resulting radial contraction, the rigid cylinder 12 moves a distance D from its longitudinal axis 22. do.

[0022] Figure 7 shows the stent of the present invention, further including a loading block 38 that can be fitted into a rigid cylinder 12. This is an exploded view of one specific embodiment of a graft crimping device. Loading block 38 is a typical example. In terms of type, acrylic nitrile butadiene styrene (ABS) type material is used, and the shape is formed by 3D printing. The loading block 38 defines an opening 40 in a plane 42 perpendicular to the longitudinal axis 21 of the rigid cylinder 12. The opening 40 defines a central axis 44 that is parallel to the longitudinal axis 22 of the rigid cylinder 12 but spaced apart from the longitudinal axis 22 of the rigid cylinder 22. In one particular embodiment, the loading tube B46 is secured by appropriate means such as interference fit, as shown in Figure 8, to the rigid cylinder 12 The loading block 38 extends from the opening 40, opposite the portion 48 of the loading block 38 that interlocks with it. The loading tube 46 typically interlocks with the loading block 38 by interference fit and is formed of a transparent PTFE tubular material. The loading tube 46 may be an intermediate means, and the radially clamped, radially self-expanding prosthesis 34, once delivered to the loading tube 46, is covered by a substitute for the loading tube 46 having a secondary sheath (not shown) of the surgical delivery device.

[0023] In another aspect of the present invention, the stent graft loading system 50 includes a rigid cylinder 12 and a flexible sheet 24, as well as at least one stent graft delivery device It includes components. As shown in Figure 9, for example, the stent graft loading system 50 is robust In addition to the cylinder 12 and flexible sheet 24, it includes a guidewire catheter (not shown) extending through the apical clasp catheter 52. The guidewire catheter 54 has a distal end 56 and a proximal end (not shown) and is part of a prosthesis delivery device used by surgeons or for demonstration by field staff. The apical clasp component 58 of the stent graft loading system 50 includes a distal clasp component 60 that is secured at the distal end 56 of the guidewire catheter 54. The proximal clasp component 62 of the apical clasp component 58 includes a tine 64 that extends distally from the proximal clasp component 62. The apical clasp catheter 52 extends proximal from the proximal clasp component 62 of the apical clasp component 58. The proximal clasp component 62 is matable with the distal clasp component 60 as shown in Figure 10. Appropriate clasp components For example, US 8,292,943 and US 8,292,943, the entire instruction of which is referenced throughout. It can be found in 10,646,365 instances.

[0024] As can be seen in Figure 11, in one particular embodiment, the loading rod 68 is a delivery device Before fully assembling, the loading rod 68 can be releasably secured to the distal end 56 of the guidewire catheter 54 by threading it into the threaded distal end 56 of the guidewire catheter 54. The loading rod 68 is typically made of stainless steel.

[0025] In one embodiment of the stent graft loading system 50 of the present invention, a radially self-expanding stent graft 34 is located in a pocket 32 ​​defined in a flexible sheet 24, but is partially withdrawn from the pocket 32, as shown in Figure 9, for example, to load the stent graft of the present invention. The components of the stent graft delivery system, which are also components of the loading system 50, can be given an axis (allow). Specifically, in one embodiment, a radially self-expanding stent graft 34 It includes a tubular graft component 70 having a proximal end 72 and a distal end (not shown). As shown in Figure 9. To this end, the radially self-expanding stent graft 34 includes a crown stent 74 fixed to the proximal end 72 of the lumen graft component 70. The crown stent 74 is proximal to and adjacent to the clasp stent 76. The clasp stent 76 includes at least one bare apex 78 exposed to the lumen 80 of the lumen graft component 70.

[0026] In the embodiments shown in Figures 9-13, the proximal clasp component is the proximal clasp component 62 It includes teeth 64 or prongs that extend distally from the end and are capable of engaging with the distal clasp component 60. Furthermore, at least one bare proximal apex 78 of the clasp stent 76 is as shown in Figure 13. The teeth 64 of the distal clasp component 60 are connected to at least one bare apex 78 of the clasp stent 76. The distal movement of the apical capture catheter 52, which moves through to engage with the distal apical clasp component 60, thereby capturing the bare proximal apex 78, can capture it between the teeth 64 of the proximal clasp component 62 and the distal clasp component 60. One bare apex can be captured between the teeth 64 of the proximal clasp component 62 and the distal clasp component 60. It is then captured by the claws of each component 62. Then at least one bear proximal apex 78 This can be released by the proximal movement of the apical clasp catheter 52, thereby moving the proximal clasp component 62 to a position where it is not engaged with the distal clasp component 60.

[0027] In another embodiment, either independently or in combination with any of the embodiments described above, the radially self-expanding stent graft 34 includes at least one suture loop 82 at the proximal end 72 of the radially self-expanding stent graft 34 and within the radially self-expanding stent graft 34, as shown in Figure 14. In this embodiment, typically at least one support wire 84 is fixed to the apical clasp catheter 52 and extends distally therefrom. The at least one support wire 84 is passed through at least one suture loop 82, as shown in Figure 15.

[0028] In yet another embodiment, separately from or in combination with any of the other embodiments described herein, the radially self-expanding stent graft 34 includes an S-rod support 86 fixed to the lumen graft component 70 of the radially self-expanding stent graft 34, Thus, the S-rod support 86 is a radially self-expanding stent graph, as can be seen in Figure 16. When the to 34 is loaded into the pocket 32 ​​defined by the flexible sheet 24, it is located directly opposite the longitudinal slot 20 of the rigid cylinder 12.

[0029] In one embodiment, separately from or in combination with any of the other embodiments described herein, the guidewire catheter 54 (for example, shown in Figure 9) is curved (as may be seen in Figure 17). In one such embodiment, the stent graft includes a support rod 86 (also referred to as the “S rod,” exemplified, for example, in US 8,292,943, the entire teaching of which is incorporated by reference). As described above, the support rod 86 is the curved 53 and rigid saddle of the top capture catheter 52 shown in Figure 17. It is located above the long side slot 20 of Linder 12.

[0030] In another embodiment, the present invention is a method for loading a stent graft, for example, a radially self-expanding stent graft 34, into a stent graft delivery device. In one embodiment of the method of the present invention, the method involves loading the radially self-expanding stent graft 34, which is defined by a flexible sheet 24 and has a straight edge 26 and a second edge 30 opposite the straight edge 26. The process includes loading the flexible sheet 24 into a pocket 32 ​​having a straight edge 26 defined by a rigid cylinder 12, extending parallel to a longitudinal slot 20 that extends parallel to the longitudinal axis 22 of the rigid cylinder 12, and having an adjacent raised component 28, the flexible sheet 24 extending from the raised component 28 of the straight edge 26 through the longitudinal slot 20 to a lumen 18 defined by the rigid cylinder 12, and from within the lumen 18 to the longitudinal slot of the second edge 30 of the flexible sheet 24 It extends outward through the rigid cylinder 12 through the 20, thereby defining a pocket 32 ​​of the flexible seat 24.

[0031] As shown above with respect to Figures 5A and 5B and 6A and 6B, the second edge 30 of the flexible sheet 24 is pulled away from the rigid cylinder 12, for example by hand, and to it This further reduces the volume of the pocket 32, radially contracts the radially self-expanding stent graft 34, and moves the longitudinal axis 36 of the radially self-expanding stent graft 34 away from the longitudinal axis 22 of the rigid cylinder 12 and toward the longitudinal slot 22 of the rigid cylinder 12.

[0032] Next, the radially self-expanding stent graft 34 is directed from the pocket 32 ​​to the loading tube 46 along its longitudinal axis 36, and the radially self-expanding stent graft 34 is in a radially contracted position. In one embodiment, the radially self-expanding stent graft 34 is directed from the pocket 32 ​​to the loading tube 46 through an opening 40 of the loading block 38 at one end of the rigid cylinder 12, as shown in Figure 18. The opening 40 defined by the loading block 38 has a diameter smaller than the diameter of the pocket 32 ​​before the pocket 32 ​​and the radially self-expanding stent graft 34 are radially contracted, and the loading block 38 is beveled around the opening 40.

[0033] Next, the loading block 38, flexible sheet 24 and rigid cylinder 12 may be removed, and the loading tube 46 is then replaced by a flexible sheath 88 of the stent graft delivery device along the longitudinal axis 36 of the radially self-expanding stent graft 34, as in “Step 1” of Figure 19. As can be seen in the transition to "Process 2", it is contracted radially. More specifically, The loading block 38, flexible sheath 24, and rigid cylinder 12 are transposed proximal to each individual loading the stent graft delivery device relative to the outer diameter of the main sheath of the system, as indicated by arrow 90. The stent graft loading system 50, loading block 38, flexible sheath 24, and rigid cylinder 12 are moved away but are not removed from the delivery system until the stent graft is fully loaded into the stent graft delivery system.

[0034] In yet another embodiment, the method of the present invention, as can be seen in Figure 18, involves crimping a radially self-expanding stent graft 34 within a pocket 32 ​​defined by a flexible sheet 24 of the stent graft crimping device 10 of the present invention, before crimping at least one proximal bare apex 78 of the clasp stent 76 of the radially self-expanding stent graft 34, This includes the step of securing it to the top clasp component 58 of the graft delivery device.

[0035] In one such embodiment, the method further includes the steps of removing the clasp stent 76 of the radially self-expanding stent graft 34 from the pocket 32 ​​and then re-orienting the clasp stent 76 back into the pocket 32, before securing the proximal bare apex 78 of the clasp stent 76 to the apex clasp component 58 of the stent graft delivery device, as can be seen in Figure 9, and then orienting the clasp stent 76 back into the pocket 32. This includes the process of applying the product.

[0036] In yet another embodiment, the method of the present invention includes passing at least one support wire 84 of a stent graft delivery device through a suture loop 82 of a radially self-expanding stent graft 34 before the radially self-expanding stent graft 34 is radially contracted, as can be seen in Figures 14 and 15. In yet another embodiment, the method further includes radi The procedure includes applying a clamp to the threaded suture loop 82 before the self-expanding stent graft 34 is contracted radially.

[0037] In another embodiment of the method, which may be performed in combination with any of the method steps described above, the loading rod 68 is screwed onto the distal end 56 of the guidewire catheter 54 of the stent graft delivery device, as can be seen in Figure 11.

[0038] In yet another embodiment, if the radially self-expanding stent graft 34 includes support rods 86, the support rods 86 of the radially self-expanding stent graft 34 are oriented during loading into the radially opposite pockets 32 of the longitudinal slot 20 of the rigid cylinder 12, as can be seen in Figure 16.

[0039] All patents, published applications, and references cited herein are incorporated by reference in their entirety. All relevant teachings are incorporated by reference in their entirety by U.S. Patent Nos.: 7,763,063; 8,007,605; 8,062,345; 8,062,349; 8,070,790; 8,292,943 and 8,308,790, 8,740,963, 9,198,786, 9,320,631, 9,364,314 and Appropriate systems, delivery devices and system components as described in 9,592,112, A tent graft may be used to deliver the aortic graft assembly of the present invention by the method of the present invention.

[0040] While exemplary embodiments are specifically shown and described, it will be understood by those skilled in the art that various modifications in form and detail can be made in the present invention without departing from the scope of embodiments included in the appended claims. The following are examples of aspects of the present invention. Item 1 a) A rigid cylinder having an outer surface and an inner surface, defining a lumen and a longitudinal slot extending parallel to the longitudinal axis of the rigid cylinder; and b) A flexible sheet having a straight edge, a raised component at the straight edge, and a second edge opposite the straight edge, wherein the raised component and the straight edge are rigid The flexible sheet is parallel to the longitudinal slot on the outer surface of the cylinder and adjacent to the longitudinal slot, and extends from the straight edge through the slot into the rigid cylinder lumen and from the lumen through the longitudinal slot to a second edge on the outer surface of the rigid cylinder, thereby rigid Define the pocket of the flexible sheet within the lumen of the cylinder. A stent graft crimping device for radially shrinking a stent graft, including [specific component]. Section 2 A stent graft crimping device further comprising a loading block that is fittable to a rigid cylinder and defines an opening in a plane perpendicular to the longitudinal axis of the rigid cylinder, wherein the opening defines a center on the axis and parallel to the longitudinal axis of the rigid cylinder, but is spaced away from the longitudinal axis of the rigid cylinder and grips a second edge of a flexible sheet opposite a straight edge. As a result of tensioning, the radial contraction of the stent graft within the pocket defined by the flexible sheet aligns the longitudinal axis of the stent graft with the center of the opening defined by the block, thereby allowing the stent graft to contract radially, move longitudinally through the opening from the rigid cylinder, and be loaded into the loading tube, according to the stent graft crimping device of item 2. Section 3 a) A rigid cylinder having an outer surface and an inner surface, defining a lumen and a longitudinal slot extending parallel to the longitudinal axis of the rigid cylinder; b) A flexible sheet having a straight edge, a raised component at the straight edge, and a second edge opposite the straight edge, wherein the raised component and the straight edge are rigid The flexible sheet extends parallel to and adjacent to the longitudinal slots on the outer surface of the cylinder, extending from a straight edge through the slots into the lumen of the rigid cylinder and from the lumen through the longitudinal slots to a second edge on the outer surface of the rigid cylinder, thereby supporting the rigid cylinder. Define a pocket for a flexible sheet within the lumen of the duct; c) A guidewire catheter extending through the pocket, the catheter having a distal end and a proximal end; d) A apical clasp component fixed to the distal end of a guidewire catheter, the apical clasp component being fittable to the distal clasp component and the distal clasp component at the distal end of the guidewire catheter, and including a proximal clasp component located proximal to the distal clasp component; and e) A apical clasp catheter fixed to the proximal clasp component of the apical clasp component and extending proximal to the proximal clasp component. A stent graft loading system, including a stent graft loading system. Section 4 The stent graft loading system according to item 3, further comprising a loading rod that can be releasably fixed to the distal end of a guidewire catheter. Section 5 The stent graft loading system according to item 3, further comprising a stent graft in a pocket defined by a flexible sheet. Section 6 The stent graft includes a lumen graft component having a proximal end and a distal end, and the stent graft includes a crown stent fixed to the proximal end of the lumen graft component and a clasp stent fixed to the lumen graft component and located within the lumen graft component, wherein the clasp stent is distal to the crown stent, adjacent to the crown stent, and the clasp stent is exposed to the lumen of the lumen graft component by at least one vent The stent graft loading system according to item 5, including a apex, which can be releasably secured to the apex clasp component. Section 7 The proximal clasp component includes a claw that extends distally from the proximal clasp component and is capable of engaging with the distal clasp component, and at least one apex of the clasp stent is the proximal clasp The sprung component and the distal clasp component may be caught between the claws, and at least one apex However, the stent graft loading system described in item 6 is released by proximal movement of the apical clasp catheter. Section 8 The stent graft loading system according to claim 7, wherein the stent graft includes at least one suture loop within the stent graft at the proximal end of the stent graft, and at least one support wire is fixed to the apical capture catheter and extends distally from the apical capture catheter, with at least one support wire passing through at least one suture loop. Section 9 The stent graft loading system according to item 3, wherein the stent graft includes a support rod, and the support rod of the stent graft is located directly opposite the slot of the rigid cylinder. Section 10 The stent graft loading system according to item 9, wherein the guidewire catheter is curved and the support rod of the stent graft is positioned above the curve of the apical capture catheter and the slot of the rigid cylinder. Section 11 a) The step of loading a stent graft into a pocket having a straight edge defined by a flexible sheet and a second edge opposite the straight edge, wherein the straight edge is The flexible sheet extends parallel to the slot defined by the rigid cylinder, has a raised component adjacent to the slot, extends parallel to the longitudinal axis of the rigid cylinder, and extends from the raised component of the straight edge through the slot into the lumen defined by the rigid cylinder, and from within the lumen through the slot to the opposite edge of the flexible sheet outside the rigid cylinder, thereby defining a pocket in the flexible sheet; b) Pull the second edge of the flexible sheet away from the rigid cylinder, thereby creating a pocket The process of reducing the volume of the stent graft to contract it radially, moving the longitudinal axis of the stent graft away from the longitudinal axis of the rigid cylinder and toward the slot of the rigid cylinder; and c) While the stent graft remains radially contracted, the stent graft is directed, thereby keeping the radially contracted stent graft radially along its longitudinal axis, and the opening defined by the block from the pocket along its longitudinal axis. The process of passing through and forming inside the loading tube, A method for loading a stent graft into a stent graft delivery device, including [details omitted]. Section 12 The method according to item 11, wherein the step of orienting the stent graft out of the pocket while keeping it radially contracted includes orienting the radially contracted stent graft through an opening with a block at one end of a rigid cylinder. Section 13 The method according to paragraph 12, wherein the opening defined by the block has a diameter smaller than the diameter of the pocket before the pocket and stent graft are radially contracted, and the block is beveled around the opening. Item 14 The method according to paragraph 12, wherein the loading tube is an intermediate of the stent graft delivery device, and the radially contracted stent graft is directed from the radially contracted member to the stent graft delivery device along the longitudinal axis of the radially contracted stent graft as it is being radially contracted. Section 15 Before the stent graft is deflated within the pocket of the flexible sheet, at least one proximal apex of the clasp stent of the stent graft is positioned at the apex of the stent graft delivery device. The method according to item 14, further comprising the step of securing to a clasp component. Section 16 The method according to paragraph 15, further comprising the steps of releasing the clasp stent of a radially contracted stent graft from the pocket, and then reorienting the radially contracted stent graft back into the pocket, before securing the proximal apex of the clasp stent to the apex clasp component of the stent graft delivery device. Item 17 The procedure described in paragraph 16 further includes the step of passing at least one support wire of the stent graft delivery device through the sutures of the stent graft before the stent graft is contracted radially. Method of loading. Section 18 The method according to item 17, further comprising the step of applying a clamp to the threaded suture before the stent graft is contracted radially. Section 19 The method according to item 18, further comprising the step of screwing a rod into a thread at the distal end of a guidewire catheter. Section 20 The method according to paragraph 19, wherein the stent graft includes a support rod, and the support rod of the stent graft is oriented during loading into a pocket located radially opposite to the longitudinal slot of a rigid cylinder.

Claims

1. a) i) Having an outer surface (14) and an inner surface (16), defining a lumen (18), ii) A longitudinal slot (20) extending parallel to the longitudinal axis (22) of the rigid cylinder (12) A rigid cylinder (12) having; and b) i) Straight edge (26), ii) Raised components (28) on a straight edge (26) and iii) A flexible sheet (24) having a second edge (30) opposite a straight edge (26), the flexible sheet (24) extending from the straight edge (26) through the slot (20) into the lumen (18) of the rigid cylinder (12) and from the lumen (18) through the longitudinal slot (20) to the second edge (30) on the outer surface (14) of the rigid cylinder (12), the raised component (28) remaining adjacent to the slot (20), thereby defining a pocket (32) of the flexible sheet (24) within the lumen (18) of the rigid cylinder (12). A stent graft crimping device for radially shrinking a stent graft (34), including the above.

2. The device according to claim 1, wherein the radial diameter of the pocket (32) is reduced by pulling the second edge (30) away from the longitudinal slot (20) of the rigid cylinder (12).

3. The device according to claim 1, further comprising a loading block (38) which is fittable to a rigid cylinder (12) and defines an opening (40) in a plane (42) perpendicular to the longitudinal axis (22) of the rigid cylinder (12), wherein the longitudinal axis (36) of a stent graft (34) is aligned with the center of the opening (40).

4. The device according to claim 1, further comprising a guidewire catheter (54) extending through a pocket (32), wherein the guidewire catheter (54) has a distal end (56) and a proximal end.

5. The device according to claim 4, further comprising a loading rod (68) which can be releasably fixed to the distal end (56) of a guidewire catheter (54).

6. The device according to claim 1, further comprising a stent graft (34) in a pocket (32) defined by a flexible sheet (24).

7. The device according to claim 6, wherein the stent graft (34) includes at least one suture loop (82) within the stent graft (34) at the proximal end of the stent graft (34).

8. The device according to claim 7, wherein at least one support wire (84) is passed through at least one suture loop (82).

9. The device according to claim 6, wherein the stent graft (34) includes a support rod (86).

10. The device according to claim 9, wherein the support rod (86) of the stent graft (34) is located directly opposite the slot (20) of the rigid cylinder (12).

11. The device according to claim 1, wherein the friction between the contacting surfaces of the flexible sheet (24) in the longitudinal slot (20) as the flexible sheet (24) passes through the longitudinal slot (20) provides resistance to expansion of the pocket (32).

12. The device according to claim 1, wherein when the stent graft (34) is contracted radially, the longitudinal axis (36) of the stent graft (34) moves away from the longitudinal axis (22) of the rigid cylinder (12).

13. The device according to claim 1, wherein the stent graft (34) placed in the pocket (32) is partially withdrawn from the pocket (32).

14. The device according to claim 1, wherein the raised component (28) is a two-part rivet.

Images