Methods, tools, and kits for customizing perforations in endovascular stent grafts and re-sheathing

Abstract

Methods and devices for customizing perforations of a stent graft and re-sheathing the stent graft into a delivery system. A fenestration tool may be used to create a fenestration at a desired location on the stent graft. The fenestration tool has a harpoon that pierces the graft material, and a blade holder that surrounds the harpoon and spins to create a circular fenestration based on physician controls. To re-sheath the stent graft, the physician can slide a funnel over the stent graft, causing the stent graft to constrict and enter an attached crimp tube. The physician can remove this funnel and attach a second funnel to the stent graft cover. Manipulation of a handle of the delivery system can move the stent graft cover and attached funnel to force the constricted stent graft out of the crimp tube and into the cover.

Description

METHODS, TOOLS, AND KITS FOR CUSTOMIZING PERFORATIONS IN ENDOVASCULAR STENT GRAFTS AND RE-SHEATHINGCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63 / 709,748, filed October 21, 2024 and U.S. Provisional Patent Application Serial No. 63 / 890,830, filed September 30, 2025, the entire contents of which are incorporated herein by reference.TECHNICAL FIELD

[0002] The present disclosure relates to methods, tools, and kits for creating customized perforations or fenestrations in an endovascular stent graft, and re-sheathing the stent graft into a stent graft cover.BACKGROUND|0003] Prostheses are implanted in blood vessels and other organs of living bodies. For example, prosthetic endovascular grafts constructed of biocompatible materials have been employed to replace or bypass damaged or occluded natural blood vessels. In general, endovascular grafts include a graft anchoring component that operates to hold a tubular graft component of a suitable graft material in its intended position within the blood vessel. The graft anchoring component typically includes one or more radially-compressible stents that are radially expanded in situ to anchor the tubular graft component to the wall of a blood vessel or anatomical conduit.

[0004] Rather than performing a traumatic and invasive open surgical procedure to implant a graft, endovascular grafts (e.g., stent grafts) may be deployed through a less invasive intraluminal delivery procedure. A lumen or vasculature may be accessed at a convenient and less traumatic entry point of the patient's body, and the stent graft may be routed through the vasculature to the site where the prosthesis is to be deployed. Intraluminal deployment typically uses a delivery catheter with tubes or shafts arranged for relative axial movement. For example, an expandable stent graft may be compressed and disposed within a distal end of an outer shaft of the delivery catheter fixed to an inner shaft. The deliverycatheter may then be maneuvered, typically tracked through a body lumen until a distal end of the delivery catheter and the stent graft are positioned at the intended treatment site. The stent graft can then be deployed and radially expanded within the blood vessel.

[0005] Some endovascular stent grafts include perforations or fenestrations that are specifically manufactured to allow blood flow into adjacent arteries. However, the anatomies of patients varies wildly, and thus so too do the necessary locations of these perforations or fenestrations.SUMMARY

[0006] In one embodiment, a method for customizing perforations of a stent graft based on a patient anatomy is provided. The method includes piercing a graft of the stent graft with a harpoon of a fenestration tool, the harpoon having a tapered tip. The method also includes while the tapered tip of the harpoon is pierced through the graft, sliding a blade holder along a shaft of the harpoon toward the tapered tip, where the blade holder has a central opening that receives the shaft during the sliding, and where the blade holder holds a pair of blades at an axial end thereof. The method also includes while the tapered tip of the harpoon is pierced through the graft, cutting the graft with the blades to create a perforation. The method also includes removing the blade holder and the harpoon from the graft, revealing the perforation.[0007J Another embodiment of the present disclosure includes a method for resheathing a partially- or fully-expanded stent graft into a stent graft cover of a stent graft delivery system. The method includes sliding a first funnel and a crimp tube in a proximal direction across a tip of a delivery system that may include the stent graft, where the sliding compresses the stent graft into the funnel and into the crimp tube. The method also includes removing the first funnel from the crimp tube while leaving the stent graft compressed within the crimp tube. The method also includes attaching a second funnel to the stent graft cover. The method also includes manipulating a handle of the delivery system to force the stent graft cover and attached second funnel to move in a distal direction relative to the stent graft, where the manipulation causes the stent graft to move out of the crimp tube and into the graft cover via the second funnel. The method also includes removing the crimp tube and second funnel from the delivery system.

[0008] Another embodiment of the present disclosure includes a kit for customizing perforations of a stent graft and then re-sheathing the stent graft into a stent graft cover of a delivery system. The kid comprises a holder for suspending the delivery system above a work surface, where the holder has a first part for suspending a handle of the delivery system and a second part for suspending a stent graft cover of the delivery system. The kit also includes a fenestration tool including: a harpoon, a blade holder having a central opening configured to slide axially along an outer surface of the harpoon, and a pair of diametrically-opposed blades held by the blade holder at an axial end thereof. The kit also includes a resheathing device including: an elongate crimp tube having an open interior; a first funnel having two half-shells configured to assemble about a crimp tube, where the first funnel has a funneled interior surface configured to force the stent graft through the first funnel and into the crimp tube when slid in a proximal direction relative to the stent graft; and a second funnel having two half-shells configured to assemble about the stent graft cover of the delivery system, where manipulation of the handle of the delivery system forces the stent graft cover and second funnel to move in a distal direction, where the second funnel includes an interior ledge configured to contact the crimp tube during manipulation of the handle, allowing the stent graft to transfer from within the crimp tube to within the stent graft cover.BRIEF DESCRIPTION OF THE DRAWINGS

[0009] FIG. 1 is a side view of a stent graft delivery system, according to one embodiment.

[0010] FIG. 2 is a schematic view of the stent graft delivery system in a partially-retracted configuration, according to an embodiment.

[0011] FIGS. 3 A-3C illustrate a fenestration tool and components thereof, according to an embodiment.

[0012] FIGS. 4-6 illustrate a method of making a custom fenestration or perforation in the graft material of a stent graft, according to an embodiment.10013] FIGS. 7-17 illustrate methods and tools for re-sheathing the stent graft, according to embodiment. In particular, FIGS. 7-8 shows a cone pusher and mandrel being attached to the stent graft delivery system; FIGS. 9A-9B show the cone pusher and mandrelin perspective and cross-sectional views, respectively; FIG. 10 shows a first funnel being attached to the cone pusher; FIGS. 11 A-B show the first funnel and attached crimp tube in side and cross-sectional views, respectively; FIG. 12 shows removal of the first funnel from the crimp tube; FIG. 13 shows attachment of a second funnel to the stent graft cover; FIGS.14 A-B show the second funnel in perspective and cross-sectional views, respectively; FIG.15 shows the second funnel moving distally to surround a proximal end of the crimp tube; FIG. 16 shows sequential movement of the second funnel and attached stent graft cover; and FIG. 17 shows a re-sheathed stent graft within the delivery system.

[0014] FIG. 18 shows a holder configured to hold the delivery system during these steps.[00151 FIG. 19 shows a fenestration support for supporting the newly-created fenestration from FIGS. 2-6.[0016[ FIGS. 20-41 illustrate methods and tools for recapturing and resheathing an expanded stent graft into a delivery system, according to various embodiments. In particular, FIG. 20 shows a stent graft with barbs and free flow springs at its proximal end; FIG. 21 depicts the stent graft in a deployed state and the initial engagement with a tip capture mechanism; FIG. 22 illustrates the pull rod in an open configuration with the capture fitting attached to the stent graft; FIG. 23 shows the pull rod securing the free flow springs; FIG.24 depicts a first-stage funnel for initial compression of the stent graft; FIG. 25 shows the stent graft and pull rod being inserted into the first-stage funnel; FIG. 26 illustrates the stent graft compressed within the first-stage tube; FIG. 27 shows removal of the first-stage funnel; FIG. 28 depicts opening the capture mechanism to release the free flow springs; FIG. 29 shows the free flow springs assuming their natural radially outward state; FIG. 30 illustrates introduction of the delivery system into the first-stage tube; FIGS. 31 A-E show the capture funnel with circumferential grooves for aligning the free flow springs with the delivery system; FIGS. 32A-B depict the tip capture mechanism of the delivery system and attachment of the free flow springs; FIG. 33 shows the tip capture mechanism securing the stent graft; FIG. 34 illustrates removal of the capture funnel; FIG. 35 A shows a second-stage funnel, and FIG. 35B shows connection of the second-stage funnel to the first-stage tube; FIG. 36 depicts further compression of the stent graft in the second-stage funnel; FIG. 37shows removal of the funnel portions; FIG. 38 illustrates assembly of a third-stage funnel about the delivery system; FIG. 39 shows placement of a locking ring on the third-stage funnel; FIG. 40 depicts transfer of the stent graft into the outer sheath; and FIG. 41 shows the stent graft fully resheathed within the delivery system.DETAILED DESCRIPTION

[0017] Embodiments of the present disclosure are described herein. It is to be understood, however, that the disclosed embodiments are merely examples and other embodiments can take various and alternative forms. The figures are not necessarily to scale; some features could be exaggerated or minimized to show details of particular components. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a representative bases for teaching one skilled in the art to variously employ the embodiments. As those of ordinary skill in the art will understand, various features illustrated and described with reference to any one of the figures can be combined with features illustrated in one or more other figures to produce embodiments that are not explicitly illustrated or described. The combinations of features illustrated provide representative embodiments for typical application. Various combinations and modifications of the features consistent with the teachings of this disclosure, however, could be desired for particular applications or implementations.

[0018] Directional terms used herein are made with reference to the views and orientations shown in the exemplary figures. A central axis is shown in the figures and described below. Terms such as “outer” and “inner” are relative to the central axis. For example, an “outer” surface means that the surfaces faces away from the central axis, or is outboard of another “inner” surface. Terms such as “radial,” “axial,” “diameter,” “circumference,” etc. also are relative to the central axis. For example, the “axial” direction refers to a direction parallel to a central axis of a stent graft. The terms “front,” “rear,” “upper” and “lower” designate directions in the drawings to which reference is made.(0019] Unless otherwise indicated, for the delivery system the terms “distal” and “proximal” are used in the following description with respect to a position or direction relative to a treating clinician. “Distal” and “distally” are positions distant from or in a direction away from the clinician, and “proximal” and “proximally” are positions near or ina direction toward the clinician. For the stent-graft prosthesis, “proximal” is the portion nearer the heart by way of blood flow path while “distal” is the portion of the stent-graft further from the heart by way of blood flow path.

[0020] The following detailed description is merely exemplary in nature and is not intended to limit the invention or the application and uses of the invention. Although the description is in the context of treatment of blood vessels such as the aorta, coronary, carotid and renal arteries, the invention may also be used in any other body passageways where it is deemed useful.

[0021] CUSTOMIZING PERFORATIONS IN ENDOVASCULAR STENT GRAFTS AND RE-SHEATHING10022] Endovascular stent grafting, or endovascular aneurysm repair (EVAR), is a form of treatment for abdominal or thoracic aortic aneurysm that is less invasive than open surgery. Endovascular stent grafting uses an endovascular stent graft to reinforce the wall of the aorta and to help keep the damaged area from rupturing by excluding the aneurysm from blood flow. Stent grafts are generally tubular open-ended structures providing support for damaged, collapsing, or occluded blood vessels, such as the aorta. Stent grafts are flexible, which allows them to be inserted through, and conform to, tortuous pathways in the blood vessels. For example, stent grafts may be radially expandable from a radially-compressed (or radially-constricted) configuration for delivery to the affected vessel site to a radially-expanded configuration when deployed at the affected vessel treatment site, with the radially-expanded configuration having a larger diameter than the radially-compressed configuration. Stent grafts may be inserted in the radially compressed configuration and expanded to the radially-expanded configuration either through a self-expanding mechanism, or through the use of a balloon catheter, for example.

[0023] In one example, an EVAR procedure may include inserting a guide wire into a portion of the patient’s body, such as the femoral artery. Once the guidewire is inserted into the artery, it may be gently pushed toward the site of the aneurism. A stent graft delivery system, which may include a catheter and stent graft, may be placed over the guidewire and inserted along the guidewire into the site of the aneurism. The stent graft may be guided within the catheter in its radially-compressed configuration and to the site of the aneurism.There may be radiopaque markers at a distal end of the stent graft delivery system or on the stent graft itself to allow the surgeon to guide the stent graft into the proper position. Once in proper position, the stent graft can be expanded from the radially-compressed configuration to the radially-expanded configuration. This can be done, for example, by pulling back a stent-graft cover, allowing the stent graft to expand due to its fabric being biased outwards. Once deployed into the radially-expanded configuration, the stent graft can be held in place with metallic hooks or stents. The catheter can then be removed, while the stent graft remains.100241 FIG. 1 shows a stent graft delivery system 10 according to one embodiment. The stent graft delivery system 10 includes an endovascular catheter and extends between a proximal end 12 and a distal end 14. The terms “proximal end” and “distal end” are not intended to be limiting, as a surgical clinician may, during a procedure, in fact be located closer to the distal end 14 than the proximal end 12. Therefore, the proximal end and the distal end may be referred to as a “first end” and a “second end,” respectively.

[0025] A threaded screw gear 16 extends along an axis between the proximal end 12 and the distal end 14. The threaded screw gear 16 may be a multi-part shell configured to connect together to make a tubular screw gear. In one embodiment, the screw gear 16 is two half-shells configured to connect (e.g., snap or assemble) together.

[0026] A handle assembly 18 is provided for grip by the clinician. The handle assembly 18 may include two separable portions, namely a front grip 20 and an external slider 22. The front grip 20 may be fixed relative to the screw gear 16, and the external slider 22 may rotate about a threaded outer surface of the screw gear 16 to move linearly along the screw gear 16. For example, during deployment of a stent graft, the external slider 22 is rotated to move toward the proximal end 12. Since the external slider 22 is operatively coupled to a stent graft cover 24 surrounding the stent graft, the stent graft cover 24 is retracted with the linear movement of the external slider 22. Meanwhile, a tip 26 at the distal end 14 of the delivery system 10, which has openings to track over the guidewires, can remain steady within the vessel as the stent graft cover 24 is retracted away from the tip 26. Retraction of the stent graft cover 24 allows the stent graft to expand within the patient'svessel. Once the stent graft is deployed, the entire stent graft delivery system 10 may be retracted from the patent’s vessel.

[0027] The stent graft (an embodiment of which is described further below) can be self-expanding, in that it includes structures that are shaped or formed from a material that can be provided with a mechanical memory to return the structure from a compressed or constricted delivery configuration to an expanded deployed configuration. The stent graft can include two main components: a tubular graft, and one or more stents for supporting and expanding the graft. The graft may be formed from any suitable graft material, for example and not limited to, a low-porosity woven or knit polyester, DACRON material, expanded polytetrafluoroethylene, polyurethane, silicone, or other suitable materials. In another embodiment, the graft material can also be a natural material such as pericardium or another membranous tissue such as intestinal submucosa. The stent is radially-compressible and expandable, is coupled to the graft material for supporting the graft material, and is operable to self-expand into apposition with the interior wall of a body vessel (not shown). Each stent can be constructed from a self-expanding or spring material, such as but not limited to Nitinol, stainless steel, a pseudo-elastic metal such as a nickel titanium alloy or nitinol, various polymers, or a so-called super alloy, which may have a base metal of nickel, cobalt, chromium, or other metal, or other suitable material. This allows the stent graft to expand when the stent graft cover 24 is retracted therefrom. The stent may be a sinusoidal patterned ring including a plurality of crowns or bends and a plurality of struts or straight segments with each crown being formed between a pair of opposing struts. In other embodiments, the stent graft may be balloon-expandable, wherein the stent(s) are not mad of a shape memory material, but rather are expanded and plastically deformed using a balloon. While embodiments herein will be described primarily with respect to self-expanding stent grafts, the same concepts are contemplated to be used with balloon-expandable stent grafts.

[0028] While the screw gear 16 is illustrated and described herein as having a threaded outer surface, it should be understood that in other embodiments, the screw gear is not threaded, the external slider 22 can slide linearly along the screw gear, or any other suitable mechanism may be used to retract the graft cover.

[0029] The stent graft delivery system 10 may also include an access port 28. The access port 28 provides an opening for insertion, removal, or receiving of a secondary guidewire lumen, or branching lumen, for surrounding a secondary guidewire. The delivery system 10 can track along both the main guidewire and the secondary guidewire during delivery of the stent graft.

[0030] For EVAR procedures, or similar procedures using endovascular stent grafts, a physician may want to customize or modify the stent graft based upon the specific anatomy of the patient. For example, assume the stent graft delivery system 10 is used for a repair within the patient’ s ascending aorta. The stent graft may be positioned within the aorta, and may have an aperture aligned with the brachiocephalic artery, the left common carotid artery, and / or the left subclavian artery to allow blood flow. Similarly, in the abdominal aorta, an aperture may be aligned with the renal arteries, the celiac artery, and / or the SMA. Because not every patient has identical anatomies, the physician may want to customize where on the stent graft this aperture should be located. There is a lack of well-defined procedures and materials to teach or guide a physician how to customize the stent graft accordingly.

[0001] Moreover, stent graft delivery systems are typically sold to physicians in an assembled state, with the stent graft assuming its radially-compressed configuration within the delivery system. If the physician desires to make a customized aperture, he / she must first partially or fully withdraw the stent graft from the stent graft cover, allowing it to at least partially expand in the radial direction. Once the stent graft has expanded, the physician can make the necessary aperture. However, re-sheathing the stent graft back into the delivery system into its radially-compressed configuration can be cumbersome, difficult, and sometimes impossible. This may be an onerous procedures for a physician to accomplish.

[0032] Therefore, according to embodiments disclosed herein, a fenestration kit is provided for (a) facilitating the cutting of the aperture on the stent graft at a customized location, and (b) re-sheathing the stent graft back into the stent graft cover of the delivery system. FIGS. 2-6 illustrate methods and tools for customizing perforations for the stent graft. FIG. 19 illustrates an optional fenestration support for supporting the newly-formedperforation in the stent graft. FIGS. 7-17 illustrate methods and tools for re-sheathing the stent graft after the perforations are made. FIG. 18 illustrates a holder for suspending the delivery system above a work surface while the physician is making the perforations and / or re-sheathing the stent graft. Each of the tools and holders disclosed herein can be combined as a kit for allowing the physician to perform the methods disclosed herein.

[0033] The disclosed fenestration kit and its components may be used alongside any method of determining the location of the fenestration(s) on the stent graft. In at least one embodiment, a CT scan of a patient may be used to determine the location of the fenestration(s). Using the CT scan and, optionally, software tools or physical templates, a physician may identify a location on the stent graft to create the fenestration that will align with a branch artery when implanted. The physician may select a location on the stent graft that does not include a stent, which may require selecting a certain circumferential portion of the stent graft if the fenestration is to axially overlap with a stent (e.g., fitting the fenestration within a peak or valley of a stent).100341 FIG. 2 shows a preliminary step in which the physician prepares the delivery system for a new fenestration by partially withdrawing the stent graft cover to expose the contained stent graft. In particular, FIG. 2 shows the distal end 14 of the delivery system 10. Here, the physician has manipulated the handle assembly 18 in such a way (e.g., by rotation of external slider 22) so as to cause the stent graft cover 24 to retract or move in the proximal direction (e.g., to the left in FIG. 2). The withdrawing of the stent graft cover 24 causes at least a portion of a stent graft 30 to expand radially outwardly. In order to make the customized fenestration, the physician can withdraw the stent graft cover 24 so that only a portion of the stent graft 30 necessary to make the fenestration is exposed. Alternatively, the physician may withdraw the stent graft cover 24 so that the entire stent graft 30 is expanded outwardly and is free from constraint from the stent graft cover 24.[0(135] With the stent graft 30 at least partially exposed and free from the stent graft cover 24, the physician can begin to make the fenestration. To do so, the physician may use a fenestration tool 40 as illustrated in FIGS. 3A-3C. FIG. 3A illustrates a harpoon 42 in isolation, FIG. 3B illustrates a blade holder 44 in isolation, and together the harpoon 42 and blade holder 44 provide the fenestration tool 40. The harpoon 42 has an elongate, generallycylinder body 46 that leads to a tapered tip 48. The tapered tip 48 is sized and configured such that it can easily puncture the graft material of the stent graft 30, as will be described further below. The tapered tip 48 is spaced from the body 46 by a gap 50 to allow the graft material to be located in the gap 50 during the cutting of the graft material, as will be described below. The tapered tip 48 also has a leading edge 52 that punctures the graft material, and a ledge 54 spaced from the leading edge 52. The ledge 54 is wider than the tapered tip 52 and is configured to contact the inside surface of the graft material if pressure is desired to be placed on the graft during cutting, as will be described.10036] As shown in FIG. 3B, the blade holder 44 has a generally cylindrical body 60 with a hollow passageway 62 within. The hollow passageway 62 is sized (e.g., cylindrical) to receive the body 46 of the harpoon 42, such that the body 46 can slide in and out of the passageway 62. Moreover, the blade holder 44 is able to rotate about and relative to the body 46 of the harpoon 42 during the cutting of the graft material. In alternative embodiments, the blade holder 44 and harpoon 42 are a single, unitary component. The blade holder 44 comprises one or a plurality of blades 64 at an axial end thereof. The blades 64 may be tapered or shaped to facilitate puncturing the graft material of the stent graft 30. While two blades 64 are illustrated in this embodiment, more or less than two blades can be provided depending on several factors such as cost, size, material of the graft, and the like. The blades 64 are also diametrically opposed (i.e., 180 degrees) from one another relative to the blade holder 40. In this way, during the cutting of the graft material, physician can rotate the blade holder 40 to cause the blades 64 to rotate and create a circular perforation or fenestration in the graft material after being rotated 180 degrees. Of course, if more than two blades are provided, the physician may only need to rotate the blade holder 44 by less than 180 degrees (e.g., 120 degrees for three blades or 90 degrees for four blades). If only a single blade 64 is provided, the physician may need to rotate the blade holder 44 by 360 degrees.

[0037] The blade holder 44 may include a blade cover 66 that is configured to slide relative to the body 60 of the blade holder 44. The physician can slide the blade cover 66 over the blades 64 to cover the blades 64 for safety purposes to that the blades 64 do not inadvertently cut items or surfaces when not in use.

[0038] The fenestration tool 40 can be used to make the fenestration or perforation. First, as shown in FIG. 4, the physician inserts the harpoon 42 into the graft material 31 of the stent graft 30 at the desired location for the new fenestration. The leading edge of the harpoon 42 pierces the graft material 31 and the physician forces the harpoon 42 radially inward until the entire tapered tip 48 has traversed the graft material 31. Due to the larger size of the body 46 relative to the tapered tip 48, the graft material 31 is captured between the body 46 of the harpoon 42 and the ledge 54 of the tapered tip 48.

[0039] Then, as shown in FIG. 5, the physician slides the blade holder 60 over and along the body 46 of the harpoon 42 until it reaches the graft material 31. There, the blades 64 contact the graft material 31, and the physician can depress the blade cover 44 so that the blades 64 are exposed and sufficiently cut into the graft material 31. At this point, the physician may desire tension or pressure to be applied to the graft material 31 to make it easier for the blades 64 to cut. To do so, the physician may pull or tug the harpoon 42 slightly away from the stent graft 30. This forces the ledge 54 of the tapered tip 48 to contact the inner surface of the graft material 31 and pull it slightly radially outward, which creates tension in the graft material.

[0040] With the blades 64 cut into the graft material 31, the physician can rotate the blade cover 44 to cause the blades 64 to rotate circumferentially relative to a central axis of the fenestration tool 40. The physician can then remove the blade holder 44 and harpoon 42 from the stent graft 30, revealing a circular fenestration or perforation 68 in the graft material 31 of the stent graft 30, as shown in the example of FIG. 6. The portion of the graft material that is removed may remain captured by the harpoon 42 such that it is safely removed from the stent graft and can be disposed of. If more than one fenestration is desired, the physician can repeat the process described above using the same fenestration tool 40 to create as many fenestrations as desired.[0(141 ] It may be desirable to support the newly-created fenestration or perforation 68 formed in the graft material 31 of the stent graft 30. The kit disclosed herein can include such a support. Referring to FIG. 19, a fenestration support 300 is illustrated. The fenestration support 300 includes a ring 302 configured to be stitched or sutured to the graft material 31 about the fenestration 68. The ring 302 is configured to provide support aboutthe fenestration 68, inhibiting the graft material from collapsing, bending, flapping, or the like at the location of the fenestration 68. In embodiments, the ring 302 can be sutured to the outer surface of the graft material 31 (i.e., facing away from the vessel). The ring 302 can be gold-plated. This allows the ring 302 to be malleable and provide corrosion resistance, while not creating adverse or toxic reactions within the body of patient. Of course this is merely exemplary, and the ring 302 can be plated with other alternative materials such as platinum, silver, electroless nickel, tin, and / or copper.

[0042] The ring 302 can come pre-attached with a one or more sutures 304. The sutures 304 can be attached to the ring 302 prior to arriving at the physician’s facility, allowing the physician to simply complete the suturing process with the graft material 31 at the desired location. The sutures 304 can also be pre-attached to one or more radiopaque markers to facilitate location of the ring 302 during imaging.

[0043] Referring to FIGS. 7-17, a method and tools for re-sheathing the stent graft 30 is disclosed according to an embodiment. The re-sheathing may take place after the customized fenestration 68 is made in the stent graft 30 according to the methods shown in FIGS. 2-6, for example.

[0044] Referring first to FIG. 7, in order to re-sheath the stent graft 30, first an alignment tool 70 is utilized. The alignment tool 70 is configured to allow subsequent components (e.g., large funnel and crimp tube, described below) to align with and attach to the distal end 14 of the delivery system 10. In embodiments, the alignment tool 70 has a cone pusher 72 and a mandrel 74. The mandrel 74 is a rod or the like that is sized to be received within the opening 76 of the tip 26 of the delivery system 10 (e.g., the lumen used to track over a guidewire). The physician can insert the mandrel 74 into the opening 76 by forcing the mandrel 74 in the proximal direction (e.g., left in FIG. 7).

[0045] As shown in FIG. 8, the physician can then slide the cone pusher in the same direction (e.g., proximally) over the tip 28 of the delivery system 10. As shown in FIG. 9B, the cone pusher 72 has a generally cylindrical outer surface 76, and a generally conical interior surface 78. The conical interior surface 78 may be shaped to match the general outer shape of the tip 26 so that as the cone pusher 72 is pushed over the tip 28, the cone pusher envelopes or circumscribes the tip 28, hiding at least a majority of the tip 28 fromview. When the cone pusher 72 cannot be pushed any further in the proximal direction (e.g., due to the distal end of the tip 28 reaching an interior end surface within the cone pusher), the cone pusher 72 provides a circumferential outer surface 76 for easy attachment of subsequent components that may have cylindrical inner attachment surfaces.

[0046] With the cone pusher 72 attached to the tip 26, the physician can then slide a first funnel 80 and attached crimp tube 82 over the cone pusher 72, as shown in FIG. 10. Of course, if the cone pusher 72 is not utilized, the first funnel 80 and crimp tube 82 can be slid directly over the tip 26 of the delivery system 10. In either embodiment, it can be said that the first funnel 80 and crimp tube 82 are slid in a proximal direction across the tip 26.

[0047] The first funnel 80 and the crimp tube 82 are illustrated in more detail in FIGS. 11 A-B. The first funnel 80 can also be referred to as a large funnel in that it is larger than a second funnel that is further described below. Referring to FIGS. 10-1 IB, the first funnel 80 has a funnel-shaped or funneled interior surface 84 that facilitates constricting of the stent graft 30 as the first funnel 80 is slid over the stent graft 30 in the proximal direction. In particular, as the physician slides the first funnel 80 in the proximal direction, the funneled interior surface 84 gradually constricts the stent graft 30.

[0048] The crimp tube 82 is a hollow, open-ended tube that is received within an end of the first funnel 80 opposite the funneled interior surface 84. In particular, the first funnel 80 can be attached about an outer surface of the crimp tube 82 prior to both being slid in the proximal direction to constrict the stent graft 30. The crimp tube 82 is configured to receive the stent graft 30 from the funneled interior surface 84 as the first funnel 80 and attached crimp tube 82 are slid in the proximal direction. In other words, the stent graft 30 is transitioned from being constricted by the funneled interior surface 84 to then being held in a constricted configuration by the crimp tube 82 as the first funnel 80 and crimp tube 82 move proximally relative to the delivery system 10 to which it attaches.

[0049] As shown in FIG. 1 IB, the interior of the first funnel 80 may include an interior ledge or wall 86. The interior ledge 86 is formed by a reduced diameter relative to the diameter that receives the crimp tube 82. In short, the interior ledge 86 acts as a stop to inhibit the crimp tube 82 from sliding proximally past the interior ledge 86. This assuresproper alignment between the first funnel 80 and the crimp tube 82 for facilitating the transfer of the stent graft 30 from the funneled interior surface 84 to the crimp tube 82.

[0050] The first funnel 80 may include two half-shells 88 assembled together. To assemble the two half-shells 88 together, one of the half-shells 88 may include a pin 90 fixed thereto, and the other half-shell can include a pocket or receptacle 92 that receives the pin 90. The two half-shell design of the first funnel 80 allows the first funnel 80 to be removed from the crimp tube 82 by simply pulling the two half-shells apart from one another, as shown in FIG. 12. The two half-shell design also allows for the first funnel 80 to be assembled to the crimp tube 82 while providing a sufficient amount of pressure or force to the crimp tube, assuring a pressure fit or interference fit between the two.

[0051] Returning to FIGS. 10-1 IB, the first funnel 80 may include a retaining ring 94. The retaining ring 94 may be a single, unitary, cylindrical component that is sized and configured to be slid over the two half-shells 88 to keep the two half-shells 88 attached to one another. In embodiments, once the two half-shells 88 are attached to the crimp tube 82, the physician can slide the retaining ring 94 over the two half-shells 88 from the distal end thereof (e.g., from the proximal side of FIGS. 10-1 IB). In order to inhibit the retaining ring 94 from sliding further along the two half-shells 88, the first funnel may include an outer ledge 96 on its exterior surface that acts as a stop when the retaining ring 94 contacts the outer ledge 96. In other words, the outer diameter of the first funnel 80 where the retaining ring 94 is located is less than the outer diameter of the first funnel 80 distally from the outer ledge 96.

[0052] The physician may slide the first funnel 80 and the crimp tube 82 in the proximal direction until the entire stent graft 30 is contained within the crimp tube 82, as shown in FIG. 12. At this time, the physician can remove the first funnel 80 from the crimp tube 82. To do so, the physician first slides the retaining ring 94 off from the outer surface of the first funnel 80 in the proximal direction. This allows the physician to separate the two half-shells 88 from one another and away from the crimp tube 82, while the stent graft 30 is retained within the crimp tube 82. The retaining ring 94 can then be slid in the distal direction and removed from the entire assembly.

[0053] Now that the stent graft 30 is held within the crimp tube 82, the physician can attach a second funnel 100 to the stent graft cover 24, as shown in FIG. 13. As explained above, the second funnel 100 can be referred to as a small funnel as it is smaller in size (e.g., inner diameter) than the first funnel 80. This can be because the outer diameter of the stent graft cover 24 is smaller than the outer diameter of the crimp tube 82. The second funnel 100 is configured to transfer the stent graft 30 from the crimp tube 82 to the stent graft cover 24, as described below.

[0054] The second funnel 100 may have two half-shell design, similar to the first funnel 80. Thus, the physician can attach the two half-shells together around the outside of the stent graft cover 24. Then, the physician can slide a (second) retaining ring 102 around an outer surface of the second funnel 100 to keep the two half-shells connected together (as shown in FIG. 15). The second funnel 100 can include a ledge or stop 104 similar to the ledge or stop 96 on the first funnel 80 that prevents the retaining ring 102 from further sliding in the distal direction. During assembly of the second funnel, the physician can first slide the retaining ring 102 over the delivery system, then attach the two half-shells of the second funnel 100 together, and then slide the retaining ring 102 in the distal direction over the outer surface of the second funnel 100 until it reaches the ledge or stop 104, as shown in FIG. 15.|0055[ Referring to FIGS. 14-15, the second funnel 100 has a funnel-shaped or funneled interior surface 106 that tapers radially inwardly from a distal end 108 of the second funnel 100 toward a ledge 110. The ledge 110 has a reduced diameter compared to a passageway 112 located proximally relative to the ledge 110. The funneled interior surface 106 and reduced diameter at the ledge 110 crimps or constricts the crimp tube 82 as the second funnel is moved toward and over the crimp tube 82. In particular, as shown in FIG.15, once the physician has assembled the second funnel 100 about the stent graft cover 24, the physician can manipulate the handle 18 to move the stent graft cover 24 and attached second funnel 100 distally, forcing the proximal end of the crimp tube 82 into the second funnel 100 until it reaches the ledge 110. This creates a tight seal and attachment between the stent graft cover 24 and the crimp tube 82 to facilitate transfer of the stent graft 30 from the crimp tube 82 into the stent graft cover 24.

[0056] FIG. 16 shows such a transfer. The physician can manipulate the handle 18 (e.g. by rotating external slider 22) to cause the stent graft cover 24 and attached second funnel 100 to move in the distal direction. Because the crimp tube 82 is locked into engagement and contacting the ledge 110, distal movement of the stent graft cover 24 and attached second funnel 100 forces the crimp tube 82 in the distal direction as well. Meanwhile, the stent graft 30 remains steady in its location, as nothing is forcing it to slide one axial direction or another. Thus, the stent graft cover 24 slides over the stent graft 30 while the crimp tube 82 slides out of engagement with the stent graft 30; the stent graft 30 slides from being constrained within the crimp tube 82 to being constrained within the stent graft cover 24, effectively re-sheathing the stent graft 30 within the stent graft cover 24. This results in a re-sheathed stent graft delivery system 10, as shown in FIG. 17.

[0057] FIG. 18 illustrates a holder 200 configured to suspend the delivery system 10 above an underlying work surface while the physician performs the methods described above. In one embodiment, the holder includes two parts, namely a first part 202 configured to hold the proximal end 12 and a second part 204 configured to hold the distal end 14. In the illustrated embodiment, the two parts 202, 204 are separated and not directly connected. However, in other embodiments, the first part 202 and second part 204 are part of a unitary structure and directly connected to one another.10058] The first part 202 has a pair of supports include a first support 206 and a second support 208. The first and second supports 206, 208 extend upward from an underlying platform 210 that can rest directly on the underlying surface. The first support 206 can be configured to directly support the proximal end 12, and the second support 208 can be configured to directly support a distal portion of the handle, such as the front grip 20. This suspends the external slider 22 above the underlying surface, allowing for free rotation of the external slider during, for example, re-sheathing the stent graft 30 into the stent graft cover 24. Each of the first and second supports 206, 208 may have a concave surface 212, 214 for contacting the proximal end 12 and the front grip 20, respectively. Since the proximal end 12 of the delivery system may have a smaller size (e.g., diameter) than the front grip 20, the first support 206 may be taller than the second support 208, and the concave surface 212 may have a smaller radius of curvature than the concave surface 214.This configuration can assure that the delivery system 10 is suspended in a horizontal orientation above the work surface.

[0059] The second part 204 has a pair of supports include a first support 216 and a second support 218 configured to suspend the stent graft cover 24. In other embodiments only one such support is provided; in yet other embodiments more than two supports are provided. Each of the first and second supports 216, 218 may have a concave surface 220 that has a radius of curvature slightly larger the radius of the stent graft cover 24 to allow the stent graft cover 24 to slide axially along the first and second supports 216, 218. The supports 216, 218 are also taller than the first and second supports 206, 208 of the first part 202 so as to hold the stent graft cover in a generally horizontal orientation.

[0060] At least one of the first support 216 and / or second support 218 can slide axially along or through an underlying platform 220 from which they extend upward. The underlying platform may include one or more slots 222, and the first support 216 may include a projection or tab that is sized to slide axially through the slot 222. This allows the first support 216 to slide relative to the second support 218, and relative to the stent graft cover 24 if so desired.

[0061] Accordingly, described herein is a kit for facilitating some or all steps of creating a custom fenestration in the operating room or at the hospital site after the original manufacture, loading, and sterilization of a stent graft and corresponding delivery system. The kit may facilitate creation of the fenestration via a cutting tool and subsequent resheathing of the stent graft into the delivery system. A holder may be provided to make either or both steps easier and faster. A reinforcement ring is provided that may support the newly created fenestration, as well as make it more visible under fluoroscopy during the EVAR procedure. Overall, the kit may make creating custom fenestrations in stent grafts easier, safer, faster, and more repeatable than the labor-intensive procedure currently used. While a total kit has been described, it should be understood that each component of the kit could be provided separately or in any sub-combination. The kit, or portions thereof, may also be used along with other tools to perform a custom fenestration and re-sheathing process.

[0062] One embodiment of the present disclosure includes a method for customizing perforations of a stent graft based on a patient anatomy. The method includes piercing a graft of the stent graft with a harpoon of a fenestration tool, the harpoon having a tapered tip. The method also includes while the tapered tip of the harpoon is pierced through the graft, sliding a blade holder along a shaft of the harpoon toward the tapered tip, where the blade holder has a central opening that receives the shaft during the sliding, and where the blade holder holds a pair of blades at an axial end thereof. The method also includes while the tapered tip of the harpoon is pierced through the graft, cutting the graft with the blades to create a perforation. The method also includes removing the blade holder and the harpoon from the graft, revealing the perforation.

[0063] Implementations of this embodiment may include one or more of the following features. For example, the method may include wherein the blades are diametrically opposed from one another relative to the central opening of the blade holder.

[0064] In another example, the step of cutting includes rotating the blades in a circumferential direction to create the perforation.

[0065] In another example, the tapered tip has a leading point and a ledge axially spaced from the leading point, and the method further comprises while the tapered tip of the harpoon is pierced through the graft, forcing the harpoon away from stent graft so that ledge provides pressure to graft material during the step of cutting.

[0066] In another example, the method further comprises before the step of piercing, withdrawing a stent graft cover to allow at least a portion of the stent graft cover to expand radially; and after the step of removing the blade holder, re-sheathing the stent graft into the stent graft cover.(0067] In another example, the step of re-sheathing includes sliding a first funnel and a crimp tube in a proximal direction across a tip of a delivery system that comprises the stent graft, wherein the sliding compresses the stent graft into the funnel and into the crimp tube; removing the first funnel from the crimp tube while leaving the stent graft compressed within the crimp tube; attaching a second funnel to the stent graft cover; manipulating a handle of the delivery system to force the stent graft cover and attached second funnel tomove in a distal direction, wherein the manipulation causes the second funnel to force the stent graft out of the crimp tube and into the graft cover; and removing the crimp tube and second funnel from the delivery system.

[0068] In another example, the method can further comprise: inserting a mandrel into an open end of the tip of the delivery system; and pushing a cone pusher over the tip of the delivery system, wherein the cone pusher includes a circumferential outer surface; wherein the step of sliding includes sliding the first funnel and crimp tube along the circumferential outer surface of the cone pusher.

[0069] Another aspect of the present disclosure includes a method for re-sheathing a partially- or fully-expanded stent graft into a stent graft cover of a stent graft delivery system. The method includes sliding a first funnel and a crimp tube in a proximal direction across a tip of a delivery system that may include the stent graft, where the sliding compresses the stent graft into the funnel and into the crimp tube. The method also includes removing the first funnel from the crimp tube while leaving the stent graft compressed within the crimp tube. The method also includes attaching a second funnel to the stent graft cover. The method also includes manipulating a handle of the delivery system to force the stent graft cover and attached second funnel to move in a distal direction relative to the stent graft, where the manipulation causes the stent graft to move out of the crimp tube and into the graft cover via the second funnel. The method also includes removing the crimp tube and second funnel from the delivery system.

[0070] Implementations of this embodiment may include one or more of the following features. For example, the method can include wherein the first funnel has a funneled interior surface configured to compress the stent graft as the first funnel is slid across the stent graft.

[0071] In another example, the crimp tube extends from a distal end of the first funnel such that the sliding forces the compressed stent graft out of the first funnel and into the crimp tube.

[0072] In another example, the first funnel includes two half-shells held together by a retaining ring, and wherein the step of removing the first funnel from the crimp tubeincludes removing the retaining ring from the first funnel and then splitting the two halfshells apart.

[0073] In another example, the second funnel includes two half-shells, and wherein the step of attaching the second funnel to the stent graft cover includes assembling the two half-shells about an outer surface of the stent graft cover.

[0074] In another example, a first of the two half-shells includes a guide pin, and a second of the two half-shells includes a receptacle configured to receive the guide pin during the step of assembling the two half-shells about the outer surface of the stent graft cover.

[0075] In another example, the method further comprises sliding a retaining ring over the two half-shells to retain the two half-shells in an assembled configuration.

[0076] In another example, the method further comprises: after the step of attaching the second funnel to the stent graft cover but before the step of manipulating the handle, sliding the second funnel in the distal direction until the second funnel circumscribes both a portion of the stent graft cover and a portion of the crimp tube.

[0077] In another example, the second funnel includes an interior ledge that contacts a distal edge of the crimp tube during the manipulation of the handle, thereby forcing the crimp tube in the distal direction during the manipulation of the handle.

[0078] In another example, the method further comprises, prior to the step of sliding the first funnel: piercing a graft of the stent graft with a harpoon, the harpoon having a tapered tip; while the tapered tip of the harpoon is pierced through the graft, sliding a blade holder along a shaft of the harpoon toward the tapered tip, wherein the blade holder has a central opening that receives the shaft during the sliding, and wherein the blade holder includes a pair of blades at an axial end thereof; while the tapered tip of the harpoon is pierced through the graft, cutting the graft with the blades to create a perforation; and removing the blade holder and the harpoon from the graft, revealing the perforation.

[0079] In another example, the blades are diametrically opposed from one another relative to the central opening of the blade holder.

[0080] In another example, the step of cutting includes rotating the blades in a circumferential direction to create the perforation.

[0081] Another aspect of the present disclosure includes a kit for customizing perforations of a stent graft and then re-sheathing the stent graft into a stent graft cover of a delivery system. The kid comprises a holder for suspending the delivery system above a work surface, where the holder has a first part for suspending a handle of the delivery system and a second part for suspending a stent graft cover of the delivery system. The kit also includes a fenestration tool including: a harpoon, a blade holder having a central opening configured to slide axially along an outer surface of the harpoon, and a pair of diametrically-opposed blades held by the blade holder at an axial end thereof. The kit also includes a resheathing device including: an elongate crimp tube having an open interior; a first funnel having two half-shells configured to assemble about a crimp tube, where the first funnel has a funneled interior surface configured to force the stent graft through the first funnel and into the crimp tube when slid in a proximal direction relative to the stent graft; and a second funnel having two half-shells configured to assemble about the stent graft cover of the delivery system, where manipulation of the handle of the delivery system forces the stent graft cover and second funnel to move in a distal direction, where the second funnel includes an interior ledge configured to contact the crimp tube during manipulation of the handle, allowing the stent graft to transfer from within the crimp tube to within the stent graft cover.

[0082] RECAPTURING AND RESHEATHING

[0083] Conventionally, stent grafts are designed for single-use deployment, and once expanded and released from the delivery system, they cannot be reloaded or reused. This limitation results in substantial waste, increased costs, and inefficiencies, particularly in clinical training, demonstration procedures, and physician-modified endovascular graft (PMEG) applications. Existing systems lack the capability to securely reattach the stent graft to the delivery system and to reload the stent graft into the delivery sheath in a controlled and repeatable manner.

[0084] The present disclosure addresses these problems by providing a set of specialized tools and procedural steps for recapturing a deployed stent graft and resheathing it into the delivery system. This disclosure includes mechanisms for re-engaging the stentgraft’s fixation elements (such as free flow springs or barbs) with the tip capture mechanism of the delivery system, as well as a series of funnels and tubes that progressively compress and transfer the stent graft back into the delivery sheath. These solutions enable safe, efficient, and repeatable recapturing and resheathing of stent grafts, reducing waste and cost, and expanding the utility of stent graft systems for training, demonstration, and advanced clinical procedures.

[0085] FIG. 20 illustrates a stent graft 400 having a plurality of barbs 402 positioned at its proximal end. The stent graft 400 is configured for implantation within a patient’s vasculature, such as the aorta or other major blood vessels, to reinforce vessel walls and exclude aneurysmal or diseased segments from blood flow. The stent graft 400 comprises a tubular graft body 404 formed from a biocompatible material, such as woven polyester or expanded polytetrafluoroethylene, and is supported by a series of radially-expandable springs or stents 406, which may be constructed from nitinol or other shape-memory alloys.

[0086] The barbs 402, which may be affixed to free flow springs 408 at the proximal end of the stent graft 400, serve multiple functions. For example, the barbs 402 are designed to anchor the stent graft 400 securely within the vessel by penetrating the vessel wall upon deployment, thereby preventing migration of the stent graft 400 and ensuring long-term fixation. In some embodiments, the barbs 402 can facilitate engagement with the tip capture mechanism of a stent graft delivery system during the recapturing and resheathing process. The free flow springs 408, in combination with the barbs 402, provide radial force to maintain the patency of the vessel and allow for controlled attachment and detachment from the delivery system. This configuration enables the stent graft 400 to be deployed, recaptured, and resheathed as needed for clinical procedures, training, or physician modification. While FIG. 20 shows a bifurcated stent graft (e.g., for use in the abdominal aorta), the present disclosure applies equally to cylindrical stent grafts or any other more complex shape.

[0087] FIG. 21 shows the stent graft 400 in its deployed state, perhaps during a demonstration of the efficacy of the delivery system and / or stent graft 400 or if a physician found it necessary or desired to fully unsheath the stent graft 400 while creating physician modifications (e.g., fenestrations). If it is desired to recapture and resheath the stent graft400, FIG. 21 shows the initial stage of doing so. As shown in FIG. 21, a tip capture mechanism 410 is provided, held by a user. The tip capture mechanism has a pull rod 412, which may include a lumen or tube that is spring-biased to close toward a capture fitting 414. Here, the user pulls back the pull rod 412 in a direction away from the capture fitting 414, which exposes fingers 416 of the capture fitting 414. Said another way, the user pulls the pull rod 412 to open or expose the capture fitting 414.

[0088] FIG. 22 illustrates the next step in the recapturing process, in which the pull rod 412 is shown in an open configuration with the fingers 416 of the capture fitting 414 attached to the stent graft 400. In this arrangement, each free flow spring 408 at the proximal end of the stent graft 400 is positioned behind (e.g., wrapping around) a separate finger 416 of the capture fitting 414. The fingers 416 are spaced circumferentially around the capture fitting 414 and are designed to securely engage the free flow springs 408 during the recapturing procedure. Once each free flow spring 408 is aligned and placed behind a corresponding finger 416, the stent graft 400 is effectively re-engaged with the tip capture mechanism. This configuration enables the stent graft 400 to be securely held and manipulated for subsequent resheathing steps, ensuring that the barbs 402 and free flow springs 408 are properly oriented and controlled during the transfer back into the delivery system.10089] Next, as shown in FIG. 23, the user releases the pull rod 412, allowing an internal spring 418 to bias the outer sheath or slider 420 of the pull rod 412 toward the capture fitting 414. This essentially closes the capture fitting, such that the outer sheath or slider 420 fits over a portion of the fingers 416, preventing the free flow springs 408 from disengaging from the fingers 416. The free flow springs 408 are now captured by the pull rod 412, such that the stent graft 400 is engaged with the pull rod 412.

[0090] The stent graft 400 is now ready to be compressed for resheathing. FIG. 24 shows a first-stage funnel 430 having a funnel portion 432 and a cylindrical portion 434. The funnel portion 432 may be press-fit or otherwise removably attached to the cylindrical portion 434. As shown in FIG. 25, the stent graft 400 and connected pull rod 412 can be inserted into the funnel portion 432 and pulled toward the cylindrical portion 434 (e.g., to the left in FIG. 25). This compresses the stent graft 400 into a first compression stage withinthe cylindrical portion 434, as shown in FIG. 26. The pull rod 412 is pulled until proximal edge 436 of the fabric of the stent graft 400 is flush with the edge 438 of the first-stage funnel 430, represented by the dashed line in FIG. 26. This allows exposer of the free flow springs 408, as they are no longer entirely bound by the first-stage funnel 430.

[0091] Once in this configuration, the funnel portion 432 of the first-stage funnel 430 can be removed from the cylindrical portion 434, as shown in FIG. 27. This allows the user to move the slider 420 of the pull rod 412 against the spring bias (e.g., to the left in FIG. 28) to open the capture mechanism 414. This exposes the fingers 416 entirely, allowing the user to remove the free flow springs 408 from the fingers 416. To do so, the user can provide a slight force of the entire tip capture mechanism 410 toward the constrained stent graft 400. By doing so, the free flow springs 408 are allowed to assume their natural state of being biased radially outward, shown in FIG. 29.(0092] Now, a delivery system 440 can be introduced into the resheathing process. The delivery system 440 is a specialized medical device designed to facilitate the controlled transport, positioning, and deployment of the stent graft 400 within a patient’s vasculature. The delivery system 440 typically comprises an elongate catheter 441 or shaft assembly that extends between a proximal end, which is manipulated by the clinician, and a distal end, which interfaces with the stent graft 400 during the procedure. As shown in FIG. 30, the first-stage funnel 430 with the compressed stent graft 400 is slid over the delivery system 440. In other words, the delivery system 440, led by a tip 442 at the distal end of the delivery system 440, is inserted into the center of the first-stage funnel 430, through the interior of the stent graft 400 (e.g., to the left in FIG. 30).

[0093] Once the delivery system 440 is inserted into the first-stage funnel 430, a capture funnel 450 is slid over the first stage funnel 430, as shown in FIG. 31 A. FIGS. 31B-E show additional views of the capture funnel 450 in isolation, while FIG. 31A shows the capture funnel 450 in its intended position about the first stage funnel 430. The capture funnel 450 is a specialized component used during the recapturing and resheathing process of the stent graft 400.

[0094] As shown in FIGS. 31B-E, the capture funnel 450 is designed with a series of circumferential grooves 452 that serve to guide the barbs 402 and free flow springs 408of the stent graft 400 as they are transferred into alignment with the tip capture mechanism of the delivery system 440. The grooves 452 are strategically positioned around the interior surface of the capture funnel 450, and in the illustrated embodiment, five grooves are shown. However, the number of grooves may vary depending on the specific configuration of the stent graft 400, and more or fewer grooves can be provided to accommodate different stent designs and different number of free flow springs 408 and / or barbs 402 (e.g., one groove per spring). As the stent graft 400 is advanced through the capture funnel 450, the barbs 402 and the straight portions of the free flow springs 408 are directed into the grooves 452, which circumferentially align the capture points of the springs with the corresponding engagement features of the delivery system 440. The grooves 452 can taper radially and circumferentially inward in a direction from a proximal end 454 to a distal end 456 of the capture funnel 450. Due to the taper of the grooves going radially inward, the advancement of the stent graft 400 through the capture funnel 450 causes the free flow springs to also compress or constrict radially inwardly, while maintaining uniform spacing about the center axis due to the fixed alignment of the grooves 452.

[0095] In embodiments, the grooves 452 can have a variable depth. This is illustrated in FIG. 3 IE, where a central region of the capture funnel 450 having the grooves 452 has variable depth in the grooves 452. In other words, the thickness of the grooves 452 is not uniform throughout the capture funnel 450. This helps to ensure the barbs 402 and springs 408 do not catch or become obstructed on the groove surfaces during the alignment process. The tapered design allows the straight part of each spring 408 to smoothly pass through the groove and reach its intended position without interference.10096] The delivery system 440 can also have a tip capture mechanism 460 that captures the free flow springs 408. FIG. 32A shows the free flow springs 408 of the stent graft being guided onto knobs 462 of the tip capture mechanism 460, and FIG. 32B shows an isolated view of the tip capture mechanism 460 with one free flow spring 408 attached thereto, for illustrative purposes. As shown in FIGS. 32A-B, the tip capture mechanism 460 has a spindle 464 with the knobs 462 extending radially outward therefrom. The knobs 462 are sized such that each free flow spring is wrapped or hooked around one of the knobs 462. The delivery system is advanced through the capture funnel 450 until the free flow springs 408 are compressed and each automatically guided to wrap around a corresponding one ofthe knobs 462 of the tip capture mechanism 460. A sleeve 466 of the tip capture mechanism can slide axially to cover the knobs 462 once the springs 408 are wrapped around the knobs 462, to hold the springs 408 in their compressed state and securely wrapped around the knobs 462. This is shown in FIG. 33 as the subsequent step of this resheathing process. This closes the tip capture mechanism 460 on the delivery system 440, and links the compressed stent graft 400 to the distal end of the delivery system 440. Once this is done, the capture funnel 450 can be removed from the first-stage funnel 430, as shown in FIG. 34.

[0097] A subsequent step of the resheathing process can now take place, in which a second-stage funnel is used. FIG. 35 A shows a view of the second-stage funnel 470 in isolation, and FIG. 35B shows the second-stage funnel connected with the cylindrical portion 434 of the first-stage funnel 430. The second-stage funnel 470 includes a cylindrical portion 472 and a funnel portion 474, each of which may be made of a plastic or the like. The funnel portion 474 can be press-fit or otherwise removably attached to the cylindrical portion 472. Moreover, the funnel portion 474 may have two portions: a first potion 476 configured to attach to the first-stage funnel 430, and a second portion 478 configured to attach to the cylindrical portion 472. Because the cylindrical portion 472 has a different (e.g., reduced) diameter compared to the cylindrical portion 434 of the first-stage funnel 430, the funnel portion 474 may have one or more central apertures with two different diameters: one in the first portion 476 to receive the cylindrical portion 434 of the first-stage funnel 430, and another in the second portion 478 to receive the cylindrical portion 472 of the second-stage funnel 470. The funnel portion 474 of the second-stage funnel 470 effectively connects the first-stage funnel 430 to the second-stage funnel 470.

[0098] With the first-stage funnel 430 connected to the second-stage funnel 470, the delivery system 440 can be advanced distally and / or the second-stage funnel 470 can be pushed proximally, which moves the compressed stent graft 400 from the first-stage funnel 430 into the smaller, more constrictive second-stage funnel 470. This compresses or constricts the stent graft 400 even more. This is shown in FIG. 36, with the arrow showing the direction of movement of the first-stage funnel 430 and the connected second-stage funnel 470. In FIG. 36, the compressed stent graft 400 is now located within the confines of the cylindrical portion 472 of the second-stage funnel 470, and no longer within the confines of the first-stage funnel 430.

[0099] Then, the funnel portion 474 of the second-stage funnel 470 can be removed from the cylindrical portion 472 of the second-stage funnel 470, and withdrawn along with the first-stage funnel 430 in a proximal direction of the delivery system 440, as shown in FIG. 37. There, the first-stage funnel 430 and funnel portion 474 can be removed entirely and are no longer needed in the resheathing process. This removal can occur after the full resheathing procedure is completed.

[0100] Next, a third-stage funnel 480, or final funnel, can be assembled together and over the delivery system 440. This is shown in FIGS. 38-39. The third-stage funnel 480 may be a two-piece, half-shell funnel configured to clasp about the delivery system. The third-stage funnel 480 may be similar or identical to the second funnel 100 disclosed above. The third-stage funnel 480 may again have two different interior diameters (as shown in FIGS.14A-14B and disclosed above), wherein the larger diameter portion of the third-stage funnel 480 may be fitted about the cylindrical portion 472 of the second-stage funnel 470, and the smaller diameter portion of the third-stage funnel 480 may be fitted about an outer sheath 482 of the delivery system 440. The outer sheath 482 may be similar or identical to the stent graft cover 24 disclosed above, and is the final outer cover that the stent graft 400 is introduced into. FIG. 38 shows the third stage funnel 480 being assembled about the delivery system 440, and FIG. 39 shows a locking ring 481 placed about the two halves of the third-stage funnel 480 to keep the two halves assembled together (similar to retaining ring 102) while the third-stage funnel 480 is pressed onto the cylindrical portion 472 of the second-stage funnel 470.

[0101] Thereafter, the handle assembly of the delivery system 440 may be manipulated to move the sheathed stent graft 400 from the second-stage funnel 470, through the third-stage funnel 480, and into the outer sheath 482 of the delivery system, as shown in FIG. 40. The third-stage funnel 480 can then be removed, and the result is a delivery system 440 with a fully re-sheathed stent graft 400 within an outer sheath 482, as shown in FIG. 41. This last transfer may be accomplished by advancing the outer sheath 482 distally (e.g., via manipulation of the handle assembly, such as assembly 18 in FIG. 1) over the stent graft 400 and / or by grasping both the second stage funnel 470 and the outer sheath 482 and pushing them towards each other to transfer the stent graft 400 into the outer sheath 482. In the latter scenario, the handle may be held in a disengaged position such that the outer sheath482 can be moved without manipulating the handle. The cone pusher (FIGS. 9A-B) can be used to push the crimped stent into the delivery system.

[0102] While exemplary embodiments are described above, it is not intended that these embodiments describe all possible forms encompassed by the claims. The words used in the specification are words of description rather than limitation, and it is understood that various changes can be made without departing from the spirit and scope of the disclosure. As previously described, the features of various embodiments can be combined to form further embodiments of the invention that may not be explicitly described or illustrated. While various embodiments could have been described as providing advantages or being preferred over other embodiments or prior art implementations with respect to one or more desired characteristics, those of ordinary skill in the art recognize that one or more features or characteristics can be compromised to achieve desired overall system attributes, which depend on the specific application and implementation. These attributes can include, but are not limited to cost, strength, durability, life cycle cost, marketability, appearance, packaging, size, serviceability, weight, manufacturability, ease of assembly, etc. As such, to the extent any embodiments are described as less desirable than other embodiments or prior art implementations with respect to one or more characteristics, these embodiments are not outside the scope of the disclosure and can be desirable for particular applications.10103] The following examples are illustrative of the techniques described herein.10104] FIRST EMBODIMENT - PERFORATING STENT GRAFT[01051 Example 1. A method for customizing perforations of a stent graft based on a patient anatomy, the method comprising: piercing a graft of the stent graft with a harpoon of a fenestration tool, the harpoon having a tapered tip; while the tapered tip of the harpoon is pierced through the graft, sliding a blade holder along a shaft of the harpoon toward the tapered tip, wherein the blade holder has a central opening that receives the shaft during the sliding, and wherein the blade holder holds a pair of blades at an axial end thereof; while the tapered tip of the harpoon is pierced through the graft, cutting the graft with the blades to create a perforation; and removing the blade holder and the harpoon from the graft, revealing the perforation.

[0106] Example 2. The method of Example 1, wherein the blades are diametrically opposed from one another relative to the central opening of the blade holder.

[0107] Example s. The method of Example 2, wherein the step of cutting includes: rotating the blades in a circumferential direction to create the perforation.|0108| Example 4. The method of Example 1, wherein the tapered tip has a leading point and a ledge axially spaced from the leading point, the method further comprising: while the tapered tip of the harpoon is pierced through the graft, forcing the harpoon away from stent graft so that ledge provides pressure to graft material during the step of cutting.

[0109] Example 5. The method of Example 1 , further comprising: before the step of piercing, withdrawing a stent graft cover to allow at least a portion of the stent graft cover to expand radially; and after the step of removing the blade holder, re-sheathing the stent graft into the stent graft cover.

[0110] Example 6. The method of Example 5, wherein the step of re-sheathing includes: sliding a first funnel and a crimp tube in a proximal direction across a tip of a delivery system that comprises the stent graft, wherein the sliding compresses the stent graft into the funnel and into the crimp tube; removing the first funnel from the crimp tube while leaving the stent graft compressed within the crimp tube; attaching a second funnel to the stent graft cover; manipulating a handle of the delivery system to force the stent graft cover and attached second funnel to move in a distal direction, wherein the manipulation causes the second funnel to force the stent graft out of the crimp tube and into the graft cover; and removing the crimp tube and second funnel from the delivery system.

[0111] Example 7. The method of Example 6, further comprising: inserting a mandrel into an open end of the tip of the delivery system; and pushing a cone pusher over the tip of the delivery system, wherein the cone pusher includes a circumferential outer surface; wherein the step of sliding includes sliding the first funnel and crimp tube along the circumferential outer surface of the cone pusher.101121 Example 8. A method of re-sheathing a partially- or fully-expanded stent graft into a stent graft cover of a stent graft delivery system, the method comprising: slidinga first funnel and a crimp tube in a proximal direction across a tip of a delivery system that comprises the stent graft, wherein the sliding compresses the stent graft into the funnel and into the crimp tube; removing the first funnel from the crimp tube while leaving the stent graft compressed within the crimp tube; attaching a second funnel to the stent graft cover; manipulating a handle of the delivery system to force the stent graft cover and attached second funnel to move in a distal direction relative to the stent graft, wherein the manipulation causes the stent graft to move out of the crimp tube and into the graft cover via the second funnel; and removing the crimp tube and second funnel from the delivery system.

[0113] Example 9. The method of Example 8, wherein the first funnel has a funneled interior surface configured to compress the stent graft as the first funnel is slid across the stent graft.

[0114] Example 10. The method of Example 9, wherein the crimp tube extends from a distal end of the first funnel such that the sliding forces the compressed stent graft out of the first funnel and into the crimp tube.

[0115] Example 11. The method of Example 8, wherein the first funnel includes two half-shells held together by a retaining ring, and wherein the step of removing the first funnel from the crimp tube includes removing the retaining ring from the first funnel and then splitting the two half-shells apart.[0.11.6] Example 12. The method of Example 8, wherein the second funnel includes two half-shells, and wherein the step of attaching the second funnel to the stent graft cover includes assembling the two half-shells about an outer surface of the stent graft cover.

[0117] Example 13. The method of Example 12, wherein a first of the two halfshells includes a guide pin, and a second of the two half-shells includes a receptacle configured to receive the guide pin during the step of assembling the two half-shells about the outer surface of the stent graft cover.

[0118] Example 14. The method of Example 12, further comprising: sliding a retaining ring over the two half-shells to retain the two half-shells in an assembled configuration.

[0119] Example 15. The method of Example 8, further comprising: after the step of attaching the second funnel to the stent graft cover but before the step of manipulating the handle, sliding the second funnel in the distal direction until the second funnel circumscribes both a portion of the stent graft cover and a portion of the crimp tube.

[0120] Example 16. The method of Example 8, wherein the second funnel includes an interior ledge that contacts a distal edge of the crimp tube during the manipulation of the handle, thereby forcing the crimp tube in the distal direction during the manipulation of the handle.

[0121] Example 17. The method of Example 8, further comprising: prior to the step of sliding the first funnel: piercing a graft of the stent graft with a harpoon, the harpoon having a tapered tip; while the tapered tip of the harpoon is pierced through the graft, sliding a blade holder along a shaft of the harpoon toward the tapered tip, wherein the blade holder has a central opening that receives the shaft during the sliding, and wherein the blade holder includes a pair of blades at an axial end thereof; while the tapered tip of the harpoon is pierced through the graft, cutting the graft with the blades to create a perforation; and removing the blade holder and the harpoon from the graft, revealing the perforation.

[0122] Example 18. The method of Example 17, wherein the blades are diametrically opposed from one another relative to the central opening of the blade holder.[01.23] Example 19. The method of Example 17, wherein the step of cutting includes: rotating the blades in a circumferential direction to create the perforation.

[0124] Example 20. A kit for customizing perforations of a stent graft and then resheathing the stent graft into a stent graft cover of a delivery system, the kit comprising: a holder for suspending the delivery system above a work surface, wherein the holder has a first part for suspending a handle of the delivery system and a second part for suspending a stent graft cover of the delivery system; a fenestration tool including: a harpoon; a blade holder having a central opening configured to slide axially along an outer surface of theharpoon; and a pair of diametrically-opposed blades held by the blade holder at an axial end thereof; and a re-sheathing device including: an elongate crimp tube having an open interior; a first funnel having two half-shells configured to assemble about a crimp tube, wherein the first funnel has a funneled interior surface configured to force the stent graft through the first funnel and into the crimp tube when slid in a proximal direction relative to the stent graft; and a second funnel having two half-shells configured to assemble about the stent graft cover of the delivery system, wherein manipulation of the handle of the delivery system forces the stent graft cover and second funnel to move in a distal direction, wherein the second funnel includes an interior ledge configured to contact the crimp tube during manipulation of the handle, allowing the stent graft to transfer from within the crimp tube to within the stent graft cover.

[0125] SECOND EMBODIMENT - RESHEATHING STENT GRAFT

[0126] Example 21. A method of resheathing an expanded stent graft back into a stent graft cover, the method comprising: providing a stent graft having a plurality of barbs affixed to free flow springs at a proximal end of the stent graft; engaging the free flow springs of the stent graft with a tip capture mechanism of a pull rod, wherein the tip capture mechanism includes a plurality of fingers that each engage a corresponding one of the free flow springs; inserting the stent graft and pull rod into a first-stage funnel thereby compressing the stent graft into a reduced diameter configuration; while the stent graft is held within the first-stage funnel, releasing the free flow springs from the fingers of the tip capture mechanism; introducing a delivery system into the first-stage funnel, wherein the delivery system includes a tip capture mechanism configured to receive the free flow springs of the stent graft; while the delivery system is inserted within the first-stage funnel, advancing a capture funnel over the first-stage funnel, wherein the capture funnel includes a plurality of circumferential grooves configured to guide the free flow springs into circumferential alignment with the tip capture mechanism of the delivery system and into attachment with knobs of the tip capture mechanism of the delivery system; removing the capture funnel from the first-stage funnel; with the free flow springs attached to the knobs of the tip capture mechanism, advancing the stent graft from the first-stage funnel and into a second-stage funnel, wherein the second-stage funnel has a reduced interior diameter that further compresses the stent graft; attaching a third-stage funnel to an end of the second-stage funnel; attaching an outer sheath of the delivery system to the third-stage funnel; transferring the stent graft from the second-stage funnel into the outer sheath; and removing the third-stage funnel, resulting in the stent graft being fully resheathed within the outer sheath of the delivery system.

[0127] Example 22. The method of Example 21, further comprising: securing the free flow springs to the fingers of the tip capture mechanism by moving a slider of the pull rod over a portion of the fingers.

[0128] Example 23. The method of Example 22, wherein the slider is spring-biased to cover the portion of the fingers.

[0129] Example 24. The method of Example 23, further comprising: prior to the step of engaging the free flow springs of the stent graft with a tip capture mechanism of a pull rod, sliding the slider away from the fingers and against the spring-bias.

[0130] Example 25. The method of Example 21, further comprising: after the step of inserting the stent graft and pull rod into a first-stage funnel, opening the capture mechanism by moving the slider of the pull rod to expose the fingers.{0131] Example 26. The method of Example 21, further comprising: securing the free flow springs to the tip capture mechanism of the delivery system by sliding a sleeve over the engagement features.

[0132] Example 27. The method of Example 21, wherein the step of transferring is performed by manipulating a handle assembly of the delivery system.

[0133] Example 28. The method of Example 21, wherein the first-stage funnel has a funnel portion and a cylindrical portion, wherein the stent graft is held within the funnel portion of the first-stage funnel during the releasing of the free flow springs from the fingers of the tip capture mechanism.

[0134] Example 29. The method of Example 21, wherein the circumferential grooves of the capture funnel have a variable depth to prevent the free flow springs from catching on the groove surfaces during alignment.

[0135] Example 30. The method of Example 21, wherein the third-stage funnel comprises two half-shells and a locking ring configured to retain the half-shells together during transfer of the stent graft into the outer sheath.10136] Example 31. A method of resheathing an expanded stent graft, the method comprising: engaging free flow springs of the stent graft with a tip capture mechanism of a pull rod; compressing the stent graft by advancing the stent graft and pull rod into a first-stage funnel; while the stent graft is held within the first-stage funnel, releasing the free flow springs from the tip capture mechanism of the pull rod; aligning and attaching the free flow springs with a tip capture mechanism of a delivery system by advancing a capture funnel having circumferential grooves over the stent graft; removing the capture funnel from the delivery system; with the free flow springs attached to the tip capture mechanism of the delivery system, transferring the stent graft into an outer sheath of the delivery system.

[0137] Example 32. The method of Example 31, wherein the circumferential grooves of the capture funnel have a variable depth to prevent the free flow springs from catching on the groove surfaces during alignment.

[0138] Example 33. The method of Example 31, further comprising securing the free flow springs to the tip capture mechanism of the pull rod by moving a spring-biased slider over a portion of the tip capture mechanism.

[0139] Example 34. The method of Example 31, wherein the first-stage funnel comprises a funnel portion and a cylindrical portion, and the stent graft is compressed into the cylindrical portion prior to removal of the funnel portion.

[0140] Example 35. The method of Example 31 , further comprising advancing the stent graft from the first-stage funnel into a second-stage funnel having a reduced interior diameter to further compress the stent graft before transferring into the outer sheath.

[0141] Example 36. The method of Example 31, wherein the outer sheath is attached to a third-stage funnel comprising two half-shells and a locking ring configured to retain the half-shells together during transfer of the stent graft into the outer sheath.

[0142] Example 37. The method of Example 31, further comprising manipulating a handle assembly of the delivery system to advance the stent graft from the second-stage funnel into the outer sheath.

[0143] Example 38. The method of Example 31, wherein the capture funnel is removably attached to the first-stage funnel and is configured to circumferentially align the free flow springs with engagement features of the tip capture mechanism of the delivery system.

[0144] Example 39. A method of resheathing a stent graft, the method comprising: engaging a fixation element of an expanded stent graft with a capture mechanism; compressing the stent graft using a funnel; and transferring the compressed stent graft into a sheath of a delivery system.

[0145] Example 40. The method of Example 39, wherein the funnel comprises a capture funnel having a plurality of circumferential grooves configured to guide free flow springs of the stent graft into alignment with the capture mechanism.

Claims

WHAT IS CLAIMED IS:

1. A method for customizing perforations of a stent graft (30) based on a patient anatomy, the method comprising:piercing a graft (31) of the stent graft (30) with a harpoon (42) of a fenestration tool (40), the harpoon (42) having a tapered tip (48);while the tapered tip (48) of the harpoon (42) is pierced through the graft (31), sliding a blade holder (44) along a shaft (46) of the harpoon (42) toward the tapered tip (48), wherein the blade holder (44) has a central opening (62) that receives the shaft (46) during the sliding, and wherein the blade holder (44) holds a pair of blades (64) at an axial end thereof;while the tapered tip (48) of the harpoon (42) is pierced through the graft (31), cutting the graft (31) with the blades (64) to create a perforation (68); andremoving the blade holder (44) and the harpoon (42) from the graft (31), revealing the perforation (68).

2. The method according to claim 1, wherein the blades (64) are diametrically opposed from one another relative to the central opening (62) of the blade holder (44).

3. The method according to claim 2, wherein the step of cutting comprises rotating the blades (64) in a circumferential direction to create the perforation (68).

4. The method according to claim 1 or claim 2, wherein the tapered tip (48) has a leading point (52) and a ledge (54) axially spaced from the leading point (52), and the method further comprises, while the tapered tip (48) of the harpoon (42) is pierced through the graft (31), forcing the harpoon (42) away from the stent graft (30) so that the ledge (54) provides pressure to the graft material (31) during the step of cutting.

5. The method according to any one of claims 1 to 4, further comprising: before the step of piercing, withdrawing a stent graft cover (24) to allow at least a portion of the stent graft (30) to expand radially; andafter the step of removing the blade holder (44), re-sheathing the stent graft (30) into the stent graft cover (24).

6. The method according to claim 5, wherein the step of re-sheathing comprises:sliding a first funnel (80) and a crimp tube (82) in a proximal direction across a tip (26) of a delivery system (10) that comprises the stent graft (30), wherein the sliding compresses the stent graft (30) into the funnel (80) and into the crimp tube (82);removing the first funnel (80) from the crimp tube (82) while leaving the stent graft (30) compressed within the crimp tube (82);attaching a second funnel (100) to the stent graft cover (24);manipulating a handle (18) of the delivery system (10) to force the stent graft cover (24) and attached second funnel (100) to move in a distal direction, wherein the manipulation causes the second funnel (100) to force the stent graft (30) out of the crimp tube (82) and into the graft cover (24); andremoving the crimp tube (82) and second funnel (100) from the delivery system (10).

7. The method according to claim 6, further comprising:inserting a mandrel (74) into an open end of the tip (26) of the delivery system (10); andpushing a cone pusher (72) over the tip (26) of the delivery system (10), wherein the cone pusher (72) includes a circumferential outer surface (76);wherein the step of sliding comprises sliding the first funnel (80) and crimp tube (82) along the circumferential outer surface (76) of the cone pusher (72).

8. A method of re-sheathing a partially- or fully-expanded stent graft (30) into a stent graft cover (24) of a stent graft delivery system (10), the method comprising:sliding a first funnel (80) and a crimp tube (82) in a proximal direction across a tip (26) of a delivery system (10) that comprises the stent graft (30), wherein the sliding compresses the stent graft (30) into the funnel (80) and into the crimp tube (82);removing the first funnel (80) from the crimp tube (82) while leaving the stent graft (30) compressed within the crimp tube (82);attaching a second funnel (100) to the stent graft cover (24);manipulating a handle (18) of the delivery system (10) to force the stent graft cover (24) and attached second funnel (100) to move in a distal direction relative to the stent graft (30), wherein the manipulation causes the stent graft (30) to move out of the crimp tube (82) and into the graft cover (24) via the second funnel (100); andremoving the crimp tube (82) and second funnel (100) from the delivery system (10).

9. The method according to claim 8, wherein the first funnel (80) has a funneled interior surface (84) configured to compress the stent graft (30) as the first funnel (80) is slid across the stent graft (30).

10. The method according to claim 9, wherein the crimp tube (82) extends from a distal end of the first funnel (80) such that the sliding forces the compressed stent graft (30) out of the first funnel (80) and into the crimp tube (82).

11. The method according to claim 8, wherein the first funnel (80) comprises two half-shells (88) held together by a retaining ring (94), and wherein the step of removing the first funnel (80) from the crimp tube (82) comprises removing the retaining ring (94) from the first funnel (80) and then splitting the two half-shells (88) apart.

12. The method according to claim 8, wherein the second funnel (100) comprises two half-shells, and wherein the step of attaching the second funnel (100) to the stent graft cover (24) comprises assembling the two half-shells about an outer surface of the stent graft cover (24).

13. The method according to claim 12, wherein a first of the two half-shells comprises a guide pin, and a second of the two half-shells comprises a receptacle configured to receive the guide pin during the step of assembling the two half-shells about the outer surface of the stent graft cover (24).

14. The method according to claim 12 or claim 13, further comprising sliding a retaining ring (102) over the two half-shells to retain the two half-shells in an assembled configuration.

15. The method according to claim 8, further comprising, after the step of attaching the second funnel (100) to the stent graft cover (24) but before the step of manipulating the handle (18), sliding the second funnel (100) in the distal direction until the second funnel (100) circumscribes both a portion of the stent graft cover (24) and a portion of the crimp tube (82).

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