Stent graft crimping device and method of use - Patent Application 20070122997

Abstract

A stent graft crimping device for radially contracting a stent graft includes a rigid cylinder having a straight edge and a second edge defining a slot extending parallel to a longitudinal axis of a flexible sheet that extends into the rigid cylinder to define a pocket. In a method of use, a stent graft can be placed into the pocket while leaving the straight edge with the raised component in the slot defined by the rigid cylinder and radially contracted by pulling on the second edge of the flexible sheet. The stent graft crimping device can be used independently or as a system in combination with components of a stent graft delivery device.

Description

[Technical Field]

[0001] REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Provisional Patent Application No. 63 / 290,344, filed December 16, 2021, the entire contents of which are incorporated herein by reference. [Background technology]

[0002] Background of the Invention Demonstration of a stent graft delivery device typically requires the release of a radially contracted or "crimped" stent graft that has been previously loaded into one or more delivery or "introducer" sheaths. Most stent grafts delivered by such devices are self-expanding and contain multiple radially self-expanding stents, often made of alloys or shape-memory alloys. Once deployed in the course of demonstrating the surgical delivery device in which the stents were packaged during assembly and fabrication, self-expanding stent grafts are typically very difficult to reload by hand.

[0003] Known devices for loading surgical stent graft prostheses into surgical delivery devices, such as "iris crimpers," are complex, heavy, expensive, and too large for transportation by personnel responsible for sales and marketing at locations remote from their manufacturing site.

[0004] Therefore, a need exists for devices, systems and methods for loading stent grafts onto surgical delivery devices in the field. Summary of the Invention

[0005] Summary of the Invention The present invention relates generally to a stent graft crimping device and system for radially contracting a stent graft, and a method for loading a stent graft into a stent graft delivery device.

[0006] In one aspect, the invention is a stent-graft crimping device for radially contracting 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 a slot extending parallel to the longitudinal axis of the rigid cylinder. The flexible sheet has a straight edge, a raised element at the straight edge, and a second edge opposite the straight edge. The raised element and straight edge are parallel to and 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 on the outer surface of the rigid cylinder, thereby defining a pocket of flexible sheet within the lumen of the rigid cylinder.

[0007] In another aspect, the present invention is a stent-graft loading system including 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 a 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 component and straight edge are parallel to and adjacent to the longitudinal slot at 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 at the outer surface of the rigid cylinder, thereby defining a pocket of the flexible sheet within the lumen of the rigid cylinder. The guidewire catheter extends through the pocket and has a distal end and a proximal end. The apical clasp component is secured to the distal end of the guidewire catheter and includes a distal clasp component at the distal end of the guidewire catheter and a proximal clasp component mateable with the distal clasp component and proximal to the distal clasp component, and the apical clasp catheter is secured to the proximal clasp component of the apical clasp component and extends proximally therefrom.

[0008] In yet another aspect, the invention is a method of loading a stent-graft into a stent-graft delivery device, the method comprising the steps of loading the stent-graft into a pocket defined by a flexible sheet having a straight edge and a second edge opposite the straight edge, wherein the straight edge extends parallel to a slot defined by a rigid cylinder, has a raised element adjacent to it, and extends parallel to the longitudinal axis of the rigid cylinder. The flexible sheet extends from the raised element 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 of the rigid cylinder, thereby defining a pocket in the flexible sheet. The second edge of the flexible sheet is pulled away from the rigid cylinder, thereby reducing the volume of the pocket and radially contracting the stent-graft, moving the longitudinal axis of the stent-graft away from the longitudinal axis of the rigid cylinder and toward the slot in the rigid cylinder. The stent graft is directed along its longitudinal axis from the pocket to the independent radially contractible 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 simple to use and easily transportable. Furthermore, the stent-graft loading system and method for loading a stent-graft into a stent-graft delivery device of the present invention can accommodate different types of stent-grafts, such as those that use longitudinal supports, e.g., longitudinal support rods, that are sewn to the basic structure of the stent-graft, as well as those that use crown stents and clasp stents that must be attached to the apical clasp components of the surgical stent-graft delivery device. Stent-grafts that require external longitudinal supports, e.g., support wires that are secured to the surgical stent-graft delivery device, extend distally along its other components, and are threaded through the suture loops of the stent-graft, can also be accommodated by the stent-graft crimping device, system, and method of use of the present invention. [Brief explanation of the drawings]

[0010] BRIEF DESCRIPTION OF THE DRAWINGS [Figure 1] Figure 1A is a perspective view of the rigid cylinder component of one embodiment of the stent graft crimping device of the present invention, and Figure 1B is an end view of the rigid cylinder shown in Figure 1A. [Figure 2] Figure 2A is a plan view of the flexible sheet component of one embodiment of the stent graft crimping device of the present invention, and 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 prior to radial contraction of the pocket defined by the flexible sheet of the stent graft crimping device of the present invention. Figure 3B is an end 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, and 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, with a stent graft loaded into a pocket defined by a flexible sheet, prior to radially contracting the stent graft according to an embodiment of the method of the present invention. Figure 5B is an end view of the stent graft crimping device and 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 contraction of the stent-graft according to the method of the present invention, and Figure 6B is an end view of the stent-graft crimping device shown in Figure 6A. [Figure 7] FIG. 7 is an exploded view in perspective of another embodiment of a stent graft crimping device of the present invention further including a loading block and a loading tube. [Figure 8] 8 is an assembled view of the stent graft crimping device of FIG. 7. FIG. [Figure 9] Figure 9 is a detail of another embodiment of the stent graft loading system of the present invention showing the proximal end of the stent graft being partially withdrawn from the rigid cylinder to attach the clasp stent of the stent graft to the apex clasp component of the stent graft loading system and suturing of the stent graft to the support wire of the stent graft loading system. [Figure 10] FIG. 10 is an embodiment of the apex clasp component of the stent graft loading system of FIG. 9 in a closed position. [Figure 11] FIG. 11 is a perspective view of a loading rod of the stent graft loading system of FIG. 9 that is threadably securable to a guidewire catheter of a stent graft delivery device suitable for use with 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 crown stent and a clasping stent having bare proximal apices that may be captured by an apex clasp component, also shown in FIG. [Figure 13] FIG. 13 is a perspective view of the stent graft of FIG. 12 after capture by the apex clasp component. [Figure 14] FIG. 14 is a perspective view of a stent graft including suture loops through which a wire support of a delivery device suitable for use with the stent graft loading system of the present invention can be passed. [Figure 15] FIG. 15 is a perspective view of the stent graft of FIG. 14 with support wires threaded through the suture loops that are components of this embodiment 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 a stent graft crimping device of the present invention. [Figure 17] FIG. 17 is a side view of one embodiment of a stent graft delivery device suitable for use with the stent graft crimping device and stent graft loading system of the present invention. [Figure 18] Figure 18 is a perspective view of one embodiment of the method steps of the present invention, including loading a radially contracted stent graft from a rigid cylinder, through a loading block, and into a loading tube of one embodiment of the stent graft crimping device of the present invention. [Figure 19] Figure 19 is a perspective view of one embodiment of two further method steps after those shown in Figure 18, in which 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. DETAILED DESCRIPTION OF THE INVENTION

[0011] Detailed Description of the Invention The features and other details of the invention, either as steps of the invention or as combinations of parts of the invention, are more particularly described and pointed out in the claims. It will be understood that the specific embodiments of the invention are shown by way of illustration and not as limitations of the invention. The principal features of this invention can be employed in various embodiments without departing from the scope of the invention.

[0012] A description of exemplary embodiments follows.

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

[0014] When reference is made herein to an aortic prosthesis, e.g., a "stent graft," "prosthesis," "stent graft prosthesis," "vascular prosthesis," or other prosthesis, that is delivered or implanted in a patient, the word "proximal" means that a portion of the prosthesis or a component of the prosthesis is relatively close to the patient's heart, and "distal" means that a portion 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 that is used to deliver or implant a prosthesis, the word "proximal," as that term is used herein, means closer to the clinician using the delivery system. When reference is made to a delivery system in which a component of the delivery system is "distal," "distal," as that term is used herein, means further away from the clinician using the delivery system.

[0016] For clarity, the word "nearest" means "near," as distinct from the meanings ascribed to "proximal" or "distal" above with respect to either the prosthesis or the delivery system.

[0017] The component parts of one embodiment of a stent-graft crimping device 10 of the present invention for radially contracting a stent-graft are shown in Figures 1A, 1B, 2A, and 2B. As can be seen in the perspective view of Figure 1A and the end view of Figure 1B along plane B of Figure 1A, stent-graft crimping device 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 a longitudinal axis 22 of rigid cylinder 12. An example of a suitable material of construction for rigid cylinder 12 is clear acrylic. A flexible sheet 24, shown in plan and end views of Figures 2A and 2B, respectively, has a straight edge 26, a raised element 28 at straight edge 26, and a second edge 30 opposite straight edge 26. An example of a suitable material of construction for the flexible sheet is Teflon PTFE film having a thickness ranging from about 0.010 inches to about 0.050 inches, with a preferred embodiment being about 0.010 inches or 0.010 inches. Raised elements 28 of flexible sheet 24 protrude from at least one side of flexible sheet 24, as can be seen in FIG. 2B. Typically, raised elements 28 are nylon two-part push-in rivets with snap shanks.

[0018] 3A and 3B, the raised component 28 and second edge 30 of the straight edge 26 are parallel to and adjacent to the longitudinal slot 20 at the outer surface 14 of the rigid cylinder 12. The flexible sheet 24 extends from the straight edge 26 of the rigid cylinder 12 through the longitudinal slot 20 to the lumen 18, and from the lumen 18 of the rigid cylinder 12 through the longitudinal slot 20 to the second edge 30 at the outer surface 14, thereby defining a pocket 32 ​​of the flexible sheet 24 within the lumen 18 of the rigid cylinder 12.

[0019] 3A and 3B to 4A and 4B, the pocket 32 ​​defined by the flexible sheet 24 may have its radial diameter R reduced to a reduced radial diameter R′ by pulling, such as by hand, the second edge 30 in a direction A away from the longitudinal slot 20 of the rigid cylinder 12. The raised components 28 of the flexible sheet 24 prevent the straight edges 26 from being pulled into the lumen 18 of the rigid cylinder 12, and friction between the contacting surfaces of the flexible sheet 24 at the longitudinal slot 20 where the flexible sheet 24 passes through the longitudinal slot 20 may provide some resistance to the expansion of the pocket 32 ​​as it is radially contracted by pulling the second edge 30 of the flexible sheet 24.

[0020] 1A-4B during loading of a radially self-expanding stent-graft 34. As can be seen in FIG. 5B, the radially self-expanding stent-graft 34 is in a relatively relaxed state within the pocket 32 ​​defined by the flexible sheet 24 within the lumen of the rigid cylinder 12 prior to radial contraction according to 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 be coincident as shown in FIG. 5B.

[0021] Upon pulling the second edge 30 of the flexible sheet 24 away from the longitudinal slot 20 of the rigid cylinder 12, as shown in the transition from Figure 5A to Figure 6A, the radially self-expanding prosthesis 34 is radially contracted, as shown in the progression from Figure 5B to Figure 6B. When the radially self-expanding stent-graft 34 is radially contracted, 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 the example shown in Figures 5A and 5B, where the longitudinal axes 22, 36 of the rigid cylinder 12 and the radially self-expanding stent-graft 34, respectively, are coincident, the longitudinal axis 36 of the radially self-expanding prosthesis 34 moves a distance D from the longitudinal axis 22 of the rigid cylinder 12 during the radial contraction caused by pulling the second edge 30 away from the longitudinal slot 20 of the rigid cylinder 12.

[0022] 7 is an exploded view of one particular embodiment of a stent-graft crimping device of the present invention further including a loading block 38 mateable with rigid cylinder 12. Loading block 38 is typically formed by 3D printing using an acrylonitrile butadiene styrene (ABS) type material. Loading block 38 defines an opening 40 in a face 42 perpendicular to longitudinal axis 21 of rigid cylinder 12. Opening 40 defines a central axis 44 that is parallel to but spaced from longitudinal axis 22 of rigid cylinder 12. In one particular embodiment, loading tube 46 extends from opening 40 by suitable means, such as an interference fit, at a portion of loading block 38 opposite portion 48 of loading block 38 that mates with rigid cylinder 12, as shown in FIG. The loading tube 46 typically mates with the loading block 38 by an interference fit and is formed of clear PTFE tubing. The loading tube 46 may be an intermediate means whereby the radially clamped, radially self-expanding prosthesis 34, once delivered to the loading tube 46, is covered by a replacement for the loading tube 46 with a secondary sheath (not shown) of the surgical delivery device.

[0023] In another embodiment of the present invention, a stent-graft loading system 50 includes the rigid cylinder 12 and flexible sheet 24, as well as at least one component of a stent-graft delivery device. As shown in FIG. 9 , for example, the stent-graft loading system 50 includes, in addition to the rigid cylinder 12 and flexible sheet 24, a guidewire catheter (not shown) extending through an 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 for use by a surgeon or demonstration by field personnel. An apical clasp component 58 of the stent-graft loading system 50 includes a distal clasp component 60 secured at the distal end 56 of the guidewire catheter 54. A proximal clasp component 62 of the apical clasp component 58 includes tines 64 extending distally therefrom. The apical clasp catheter 52 extends proximally from a proximal clasp component 62 of the apical clasp component 58. The proximal clasp component 62 is matable with a distal clasp component 60, as shown in Figure 10. Examples of suitable clasp components can be found in US 8,292,943 and US 10,646,365, the entire teachings of which are incorporated by reference in their entirety.

[0024] 11, in one particular embodiment, the loading rod 68 can be releasably secured to the distal end 56 of the guidewire catheter 54, such as by threading it onto the threaded distal end 56 of the guidewire catheter 54, prior to fully assembling the delivery device. The loading rod 68 is typically formed of stainless steel.

[0025] In one embodiment of the stent-graft loading system 50 of the present invention, the radially self-expanding stent-graft 34 resides within a pocket 32 ​​defined in the flexible sheet 24 but may be partially withdrawn from the pocket 32 ​​to allow for alignment with components of the stent-graft delivery system that are also components of the stent-graft loading system 50 of the present invention, as shown, for example, in FIG. 9 . Specifically, in one embodiment, the radially self-expanding stent-graft 34 includes a luminal graft component 70 having a proximal end 72 and a distal end (not shown). As shown in FIG. 9 , the radially self-expanding stent-graft 34 includes a crown stent 74 secured to the proximal end 72 of the luminal graft component 70. The crown stent 74 is proximal to and adjacent to a clasping stent 76. The clasping stent 76 includes at least one bare apex 78 exposed to the lumen 80 of the luminal graft component 70.

[0026] 9-13, the proximal clasp component includes teeth 64 or prongs extending distally from the proximal clasp component 62 and matable with the distal clasp component 60, and at least one bare proximal apex 78 of the clasping stent 76 can be captured between the teeth 64 of the proximal clasp component 62 and the distal clasp component 60 by distal movement of the apex capture catheter 52, which moves the teeth 64 of the distal clasp component 60 through the at least one bare apex 78 of the clasping stent 76 into mating relationship with the distal apex clasp component 60, thereby capturing the bare proximal apex 78, as shown in FIG. 13. One bare apex is captured by each prong of the proximal apex clasp component 62. The at least one bare proximal apex 78 may then be released by proximal movement of the apex clasp catheter 52 , thereby moving the proximal clasp component 62 into a disengaged relationship with the distal clasp component 60 .

[0027] In another embodiment, independently or in combination with any of the above-described embodiments, 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 FIG. 14. In this embodiment, at least one support wire 84 is typically secured to and extends distally from the apex clasp catheter 52. The at least one support wire 84 is threaded through the at least one suture loop 82, as shown in FIG.

[0028] In yet another embodiment, separately or in combination with any of the other embodiments described herein, the radially self-expanding stent graft 34 includes an S-bar support 86 secured to the luminal graft component 70 of the radially self-expanding stent graft 34, wherein the S-bar support 86 is directly opposite the longitudinal slot 20 of the rigid cylinder 12 when the radially self-expanding stent graft 34 is loaded into the pocket 32 ​​defined by the flexible sheet 24, as can be seen in FIG. 16 .

[0029] In one embodiment, separately or in combination with any of the other embodiments described herein, the guidewire catheter 54 (e.g., as shown in FIG. 9) is curved (as can be seen in FIG. 17). In one such embodiment, the stent graft includes support rods 86 (also referred to as "S-rods" and exemplified, for example, in U.S. Pat. No. 8,292,943, the entire teachings of which are incorporated by reference). As mentioned above, the support rods 86 are in position above the curves 53 of the apical capture catheter 52 and the longitudinal slots 20 of the rigid cylinder 12 shown in FIG. 17.

[0030] In another aspect, the invention is a method of loading a stent graft, such as 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 includes the step of loading a radially self-expanding stent graft 34 into a pocket 32 ​​defined by a flexible sheet 24 and having a straight edge 26 and a second edge 30 opposite the straight edge 26, wherein the straight edge 26 has a raised element 28 adjacent thereto and extending parallel to a longitudinal slot 20 defined by the rigid cylinder 12 and extending parallel to the longitudinal axis 22 of the rigid cylinder 12, and wherein the flexible sheet 24 extends from the raised element 28 of the straight edge 26 through the longitudinal slot 20 into the lumen 18 defined by the rigid cylinder 12, and from within the lumen 18 through the longitudinal slot 20 of the second edge 30 of the flexible sheet 24 to the outside of the rigid cylinder 12, thereby defining the pocket 32 ​​in the flexible sheet 24.

[0031] As described and shown above with respect to Figures 5A and 5B and 6A and 6B, the second edge 30 of the flexible sheet 24 is pulled, for example by hand, away from the rigid cylinder 12, thereby reducing the volume of the pocket 32, radially contracting the radially self-expanding stent graft 34 and radially moving the longitudinal axis 36 of the 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] The radially self-expanding stent graft 34 is then directed along its longitudinal axis 36 from the pocket 32 ​​into the loading tube 46, with the radially self-expanding stent graft 34 in a radially contracted position. In one embodiment, the radially self-expanding stent graft 34 is directed from the pocket 32 ​​into the loading tube 46 through an opening 40 in a 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 ​​prior to radially contracting the pocket 32 ​​and the radially self-expanding stent graft 34, where the loading block 38 is beveled around the opening 40.

[0033] The loading block 38, flexible sheet 24, and stiff cylinder 12 may then be removed, and the loading tube 46 is then replaced by the flexible sheath 88 of the stent-graft delivery device along the longitudinal axis 36 of the radially self-expanding stent-graft 34, which is radially contracted, as can be seen in the transition from "Step 1" to "Step 2" in FIG. 19. More specifically, the loading block 38, flexible sheath 24, and stiff cylinder 12 are displaced proximally, as shown by arrow 90, relative to the individual loading components of the stent-graft delivery device relative to the outer diameter of the main sheath of the system. The stent-graft loading system 50, loading block 38, flexible sheath 24, and stiff cylinder 12 are moved apart 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 includes a step of fastening at least one proximal bare apex 78 of a clasp stent 76 of the radially self-expanding stent graft 34 to an apex clasp component 58 of the stent graft delivery device before crimping the radially self-expanding stent graft 34 within the pocket 32 ​​defined by the flexible sheet 24 of the stent graft crimping device 10 of the present invention, as can be seen in FIG.

[0035] In one such embodiment, the method further includes removing the clasping stent 76 of the radially self-expanding stent graft 34 from the pocket 32 ​​and then redirecting the clasping stent 76 back into the pocket 32 ​​before fastening the proximal bare apex 78 of the clasping stent 76 against the apex clasp component 58 of the stent graft delivery device, as can be seen in FIG.

[0036] 14 and 15, the method of the present invention includes threading at least one support wire 84 of a stent-graft delivery device through suture loops 82 of the radially self-expanding stent-graft 34 prior to radially contracting the radially self-expanding stent-graft 34. In yet another embodiment, the method further includes applying a clamp to the threaded suture loop 82 prior to radially contracting the radially self-expanding stent-graft 34.

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

[0038] In yet another embodiment, when 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 pockets 32 that are radially opposite the longitudinal slots 20 of the rigid cylinder 12, as can be seen in FIG.

[0039] The teachings of all patents, published applications, and references cited herein are incorporated by reference in their entirety. Suitable systems, delivery devices, and system components, stent grafts described in U.S. Patent Nos. 7,763,063; 8,007,605; 8,062,345; 8,062,349; 8,070,790; 8,292,943; 8,308,790; 8,740,963; 9,198,786; 9,320,631; 9,364,314; and 9,592,112, all relevant teachings of which are incorporated by reference herein in their entirety, can be used to deliver the aortic graft assemblies of the present invention according to the methods of the present invention.

[0040] While example embodiments have been particularly shown and described, it will be understood by those skilled in the art that various changes in form and details can be made in the present invention without departing from the scope of the embodiments encompassed by the appended claims. The present invention includes the following aspects. Item 1 a) a rigid cylinder having an outer surface and an inner surface and 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 element at the straight edge, and a second edge opposite the straight edge, wherein the raised element and straight edge are parallel to and adjacent to a longitudinal slot at the outer surface of the rigid cylinder, and wherein 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 at the outer surface of the rigid cylinder, thereby defining a pocket of flexible sheet within the lumen of the rigid cylinder; 1. A stent graft crimping device for radially contracting a stent graft, comprising: Section 2 A stent graft crimping device as described in item 2, further comprising a loading block that can be fitted into the rigid cylinder and defines an opening in a plane perpendicular to the longitudinal axis of the rigid cylinder, the opening defining an axis and a center parallel to the longitudinal axis of the rigid cylinder but spaced apart from the longitudinal axis of the rigid cylinder, and pulling a second edge of the flexible sheet opposite the straight edge results in radial contraction of the stent graft within the pocket defined by the flexible sheet aligning the longitudinal axis of the stent graft with the center of the opening defined by the block, thereby causing the stent graft to be radially contracted and movable longitudinally from the rigid cylinder through the opening and loaded into the loading tube. Section 3 a) a rigid cylinder having an outer surface and an inner surface and 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 element at the straight edge, and a second edge opposite the straight edge, wherein the raised element and straight edge are parallel to and adjacent to a longitudinal slot at the outer surface of the rigid cylinder, and wherein 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 a second edge at the outer surface of the rigid cylinder, thereby defining a pocket of flexible sheet within the lumen of the rigid cylinder; c) a guidewire catheter extending through said pocket, said catheter having a distal end and a proximal end; d) an apical clasp component secured to the distal end of the guidewire catheter, the apical capture component including a distal clasp component at the distal end of the guidewire catheter and a proximal clasp component mateable with the distal clasp component and proximal to the distal clasp component; and e) an apical clasp catheter secured to the proximal clasp component of the apical clasp component and extending proximally from the proximal clasp component; 1. A stent graft loading system comprising: Section 4 Item 4. The stent graft loading system of item 3, further comprising a loading rod that can be releasably secured to the distal end of the guidewire catheter. Section 5 Item 4. The stent graft loading system of item 3, further comprising a stent graft within a pocket defined by the flexible sheet. Section 6 A stent graft loading system as described in item 5, wherein the stent graft includes a luminal graft component having a proximal end and a distal end, the stent graft includes a crown stent fixed to the proximal end of the luminal graft component and a clasp stent fixed to the luminal graft component and located within the luminal graft component, the clasp stent being distal to and adjacent to the crown stent, the clasp stent including at least one bare apex exposed to the lumen of the luminal graft component and capable of being releasably secured to the apex clasp component. Section 7 Item 7. A stent graft loading system as described in item 6, wherein the proximal clasp component includes a claw extending distally from the proximal clasp component and capable of mating with the distal clasp component, and at least one apex of the clasp stent can be captured between the claws of the proximal clasp component and the distal clasp component, and the at least one apex is released by proximal movement of the apex clasp catheter. Section 8 Item 7: A stent graft loading system as described in item 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 apex capture catheter and extends distally from the apex capture catheter, and the at least one support wire is threaded through the at least one suture loop. Section 9 Item 4. The stent graft loading system of paragraph 3, wherein the stent graft includes a support bar, the support bar of the stent graft being diametrically opposed to the slot of the rigid cylinder. Item 10 10. The stent graft loading system of paragraph 9, wherein the guidewire catheter is curved and the support rods of the stent graft are positioned over the curve of the apical capture catheter and the slots of the rigid cylinder. Section 11 a) loading the 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 extends parallel to a slot defined by a rigid cylinder and has a raised element adjacent to the slot, extending parallel to the longitudinal axis of the rigid cylinder, and wherein the flexible sheet extends from the raised element of the straight edge through the slot into a lumen defined by the rigid cylinder and from within the lumen through the slot to an opposite edge of the flexible sheet outside of the rigid cylinder, thereby defining a pocket in the flexible sheet; b) pulling the second edge of the flexible sheet away from the rigid cylinder, thereby reducing the volume of the pocket and radially contracting the stent graft, and moving the longitudinal axis of the stent graft away from the longitudinal axis of the rigid cylinder and toward the slot in the rigid cylinder; and c) while the stent graft remains radially contracted, orienting the stent graft, thereby forming the radially contracted stent graft along its longitudinal axis from the pocket through the opening defined by the block and into the loading tube while remaining radially contracted along its longitudinal axis; 1. A method of loading a stent graft into a stent graft delivery device, comprising: Item 12 Item 12. The method of item 11, wherein the step of directing the stent graft from the pocket while keeping it radially contracted comprises directing the radially contracted stent graft through an opening in a block at one end of a rigid cylinder. Section 13 Item 13. The method of item 12, wherein the opening defined by the block has a diameter smaller than the diameter of the pocket, and the block is beveled around the opening prior to radially contracting the pocket and stent graft. Section 14 Item 13. The method of item 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 while being radially contracted. Section 15 Item 15. The method of item 14, further comprising the step of fastening at least one proximal apex of the clasp stent of the stent graft to an apex clasp component of the stent graft delivery device before shrinking the stent graft within the pocket of the flexible sheet. Item 16 Item 16. The method of item 15, further comprising the step of releasing the clasping stent of the radially contracted stent graft from the pocket and then redirecting the radially contracted stent graft back into the pocket before fastening the proximal apex of the clasping stent to the apex clasp component of the stent graft delivery device. Section 17 Item 17. The method of item 16, further comprising the step of threading at least one support wire of the stent graft delivery device through the suture of the stent graft before radially contracting the stent graft. Section 18 Item 18. The method of paragraph 17, further comprising applying a clamp to the threaded suture before radially contracting the stent graft. Section 19 20. The method of paragraph 18, further comprising the step of threading a rod onto the threads at the distal end of the guidewire catheter. Section 20 20. The method of paragraph 19, wherein the stent graft includes support rods, and the support rods of the stent graft are oriented during loading into pockets that are radially opposite the longitudinal slot of the rigid cylinder.

Claims

1. a) a rigid cylinder having an outer surface and an inner surface and 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 element at the straight edge, and a second edge opposite the straight edge, wherein the raised element and straight edge are parallel to and adjacent to a longitudinal slot at the outer surface of the rigid cylinder, and wherein 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 at the outer surface of the rigid cylinder, thereby defining a pocket of flexible sheet within the lumen of the rigid cylinder; 1. A stent graft crimping device for radially contracting a stent graft, comprising:

2. 2. The stent graft crimping device of claim 1, further comprising a loading block that can be fitted into the rigid cylinder and defines an opening in a plane perpendicular to the longitudinal axis of the rigid cylinder, the opening defining an axis and a center parallel to the longitudinal axis of the rigid cylinder but spaced apart from the longitudinal axis of the rigid cylinder, and pulling a second edge of the flexible sheet opposite the straight edge results in radial contraction of the stent graft within the pocket defined by the flexible sheet aligning the longitudinal axis of the stent graft with the center of the opening defined by the block, thereby causing the stent graft to be radially contracted and movable longitudinally from the rigid cylinder through the opening and loaded into the loading tube.

3. a) a rigid cylinder having an outer surface and an inner surface and 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 element at the straight edge, and a second edge opposite the straight edge, wherein the raised element and straight edge are parallel to and adjacent to a longitudinal slot at the outer surface of the rigid cylinder, and wherein 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 a second edge at the outer surface of the rigid cylinder, thereby defining a pocket of flexible sheet within the lumen of the rigid cylinder; c) a guidewire catheter extending through said pocket, said catheter having a distal end and a proximal end; d) an apex clasp component secured to the distal end of the guidewire catheter, the apex clasp component including a distal clasp component at the distal end of the guidewire catheter and a proximal clasp component mateable with the distal clasp component and proximal to the distal clasp component; and e) an apical clasp catheter secured to the proximal clasp component of the apical clasp component and extending proximally from the proximal clasp component; 1. A stent graft loading system comprising:

4. The stent graft loading system of claim 3 further comprising a loading rod releasably securable to the distal end of the guidewire catheter.

5. The stent graft loading system of claim 3 further comprising a stent graft within a pocket defined by the flexible sheet.

6. 6. The stent graft loading system of claim 5, wherein the stent graft includes a luminal graft component having a proximal end and a distal end, the stent graft includes a crown stent fixed to the proximal end of the luminal graft component and a clasp stent fixed to the luminal graft component and located within the luminal graft component, the clasp stent being distal to and adjacent to the crown stent, the clasp stent including at least one bare apex exposed to the lumen of the luminal graft component and capable of being releasably secured to the apex clasp component.

7. The stent graft loading system of claim 6, wherein the proximal clasp component includes a claw extending distally from the proximal clasp component and capable of mating with the distal clasp component, and at least one apex of the clasp stent can be captured between the claws of the proximal clasp component and the distal clasp component, and the at least one apex is released by proximal movement of the apex clasp catheter.

8. The stent graft loading system of 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 apex capture catheter and extends distally from the apex capture catheter, and the at least one support wire is threaded through the at least one suture loop.

9. 4. The stent graft loading system of claim 3, wherein the stent graft includes a support bar, the support bar of the stent graft being diametrically opposed to the slot of the rigid cylinder.

10. 10. The stent graft loading system of claim 9, wherein the guidewire catheter is curved and the support rods of the stent graft are positioned over the curve of the apex capture catheter and the slots of the rigid cylinder.

11. a) loading the 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 extends parallel to a slot defined by a rigid cylinder, has a raised element adjacent to the slot, and extends parallel to the longitudinal axis of the rigid cylinder, and wherein the flexible sheet extends from the raised element of the straight edge through the slot into a lumen defined by the rigid cylinder, and from within the lumen through the slot to an opposite edge of the flexible sheet outside of the rigid cylinder, thereby defining a pocket in the flexible sheet; b) pulling the second edge of the flexible sheet away from the rigid cylinder, thereby reducing the volume of the pocket and radially contracting the stent graft, moving the longitudinal axis of the stent graft away from the longitudinal axis of the rigid cylinder and toward the slot in the rigid cylinder; and c) while the stent graft remains radially contracted, orienting the stent graft, thereby forming the radially contracted stent graft along its longitudinal axis from the pocket through the opening defined by the block and into the loading tube while remaining radially contracted along its longitudinal axis; 1. A method of loading a stent graft into a stent graft delivery device, comprising:

12. 12. The method of claim 11, wherein the step of directing the stent graft from the pocket while keeping it radially contracted comprises directing the radially contracted stent graft through an opening in a block at one end of a rigid cylinder.

13. 13. The method of claim 12, wherein the opening defined by the block has a diameter smaller than the diameter of the pocket prior to radially contracting the pocket and stent graft, and the block is beveled around the opening.

14. 13. The method of claim 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 while being radially contracted.

15. The method of claim 14, further comprising the step of fastening at least one proximal apex of a clasp stent of the stent graft to an apex clasp component of the stent graft delivery device before shrinking the stent graft within the pocket of the flexible sheet.

16. 16. The method of claim 15, further comprising the step of releasing the clasping stent of the radially contracted stent graft from the pocket and then redirecting the radially contracted stent graft back into the pocket before fastening the proximal apex of the clasping stent to the apex clasp component of the stent graft delivery device.

17. 17. The method of claim 16, further comprising threading at least one support wire of the stent graft delivery device through a suture of the stent graft before radially contracting the stent graft.

18. 18. The method of claim 17, further comprising the step of applying clamps to the threaded sutures prior to radially contracting the stent graft.

19. 20. The method of claim 18, further comprising threading a rod onto a thread at the distal end of the guidewire catheter.

20. 20. The method of claim 19, wherein the stent graft includes support bars, and the support bars of the stent graft are oriented during loading into pockets that are radially opposite the longitudinal slot of the rigid cylinder.

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