Endovascular implant delivery system with tapered tip

Abstract

A tapered tip endovascular delivery system for delivering an endovascular implant within a blood vessel. The tapered tip endovascular delivery system includes a tip assembly including a tapered tip and a tip capture sleeve. The tapered tip includes a tapered tip insert. The delivery system further includes a spindle assembly including a spindle hub and a travel limiter. The tip assembly is configured to axially advance relative the spindle assembly between a covered position in which the spindle hub is at least partially disposed within the tip capture sleeve and an extended position in which the spindle hub is at least partially extended outside of the tip capture sleeve. The tapered tip insert includes a distal portion and a proximal portion including a retainer configured to retain a portion of the travel limiter in a retained position.

Description

Attorney Ref. No. A00013528W001ENDOVASCULAR IMPLANT DELIVERY SYSTEM WITH TAPERED TIPCROSS-REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63 / 779,363, filed March 28, 2025, and U.S. Provisional Patent Application Serial No. 63 / 933,959, filed December 8, 2025, the entire content of which is incorporated herein by reference.TECHNICAL FIELD[0002| The present disclosure relates generally to an endovascular delivery system for delivering an endovascular implant within a blood vessel (e.g., the aorta) and a method assembling a tapered tip endovascular delivery system.BACKGROUND

[0003] Endovascular procedures are minimally invasive techniques to deliver a variety of clinical treatments in a patient’s vasculature. One such clinical treatment that can be delivered through an endovascular procedure is an implant such as a stent graft or a transcatheter heart valve (THV). A stent graft is an implantable device formed of a surgical graft covering and an expanding or self-expanding metal frame. The stent graft may be placed inside a blood vessel (e.g., the aorta) to bridge a diseased segment (e.g., an aneurismal segment or a dissected segment) of the blood vessel, thereby excluding or mitigating hemodynamic pressures of blood flow from the diseased segment of the blood vessel.

[0004] Endovascular implants (e.g., stent grafts or THVs) may be deployed through a minimally 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 endovascular implant 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 instance, an expandable stent graft may beAttorney Ref. No. A00013528W001compressed and disposed within a distal end of an outer shaft of the delivery catheter fixed to an inner shaft. The delivery catheter 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 an intended treatment site. The expandable stent graft can then be deployed and radially expanded within the blood vessel.SUMMARY

[0005] In a first embodiment, a tapered tip endovascular delivery system for delivering an endovascular implant within a blood vessel. The tapered tip endovascular delivery system includes a tip assembly including a tapered tip and a tip capture sleeve. The tapered tip includes a tapered tip insert. The delivery system further includes a spindle assembly including a spindle hub and a travel limiter. The tip assembly is configured to axially advance relative the spindle assembly between a covered position in which the spindle hub is at least partially disposed within the tip capture sleeve and an extended position in which the spindle hub is at least partially extended outside of the tip capture sleeve. The tapered tip insert includes a distal portion and a proximal portion including a retainer configured to retain a portion of the travel limiter in a retained position.

[0006] In one or more embodiments, the retainer includes a plurality of tabs configured to retain the portion of the travel limiter in the retained position. The plurality of tabs may include two or more tabs. Each pair of adjacent tabs of the two or more tabs may form notch(s), which may be v-shaped notch(es). Each tab of the plurality tabs may include a proximal ramp configured to receive the portion of the travel limiter through axial movement of the travel limiter relative the proximal portion of the tapered tip insert. Each tab of the plurality of tabs may be configured to flex outward to receive the travel limiter. The plurality of tabs may form a proximal cavity configured to receive the portion of the travel limiter. Each of the tabs of the plurality of tabs may have circumferentially curved shape(s). Each of the tabs of the plurality of tabs may have tapered profiles in a radial, circumferential direction of the tapered tip insert. The retainer may form an open proximal end configured to receive the portion of the travel limiter.Attorney Ref. No. A00013528W001

[0007] In another embodiment, a tapered tip endovascular delivery system for delivering an endovascular implant within a blood vessel. The tapered tip endovascular delivery system comprising a tip assembly including a tapered tip and a tip capture sleeve. The tapered tip includes a tapered tip insert. The delivery system includes a spindle assembly including a spindle hub and a travel limiter. The tip assembly is configured to axially advance relative the spindle assembly between a covered position in which the spindle hub is at least partially disposed within the tip capture sleeve and an extended position in which the spindle hub is at least partially extended outside of the tip capture sleeve. The tapered tip insert includes a distal portion and a proximal portion including a retainer configured to retain a portion of the travel limiter in a retained position in which the tip capture sleeve is configured to reduce or prevent outward flexing of the retainer.

[0008] In the second embodiment, the tip capture sleeve includes an inner surface and the retainer bears against the inner surface of the tip capture sleeve in the retained position. The inner surface may be disposed in a medial axial portion of the tip capture sleeve. The retainer may include a plurality of tabs configured to retain the portion of the travel limiter in a retained position.

[0009] In a third embodiment, a method of assembling a tapered tip endovascular delivery system is disclosed. The method includes axially advancing a spindle assembly relative to a tapered tip insert. The spindle assembly includes a spindle hub and a travel limiter extending from the spindle hub. The method further includes outwardly flexing the proximal retainer to receive a portion of the travel limiter within the tapered tip insert.

[0010] The method may further include retaining the portion of the travel limiter within a proximal cavity formed by the proximal retainer. The method may include retaining the tapered tip insert with a tip capture sleeve to limit or prevent flexing of the proximal retainer. The retaining step may occur after the retaining step. The proximal retainer may include a plurality of tabs configured to retain the portion of the travel limiter in a retained position. Each tab of the plurality tabs includes proximal ramp configured to receive the portion of the travel limiter through axial advancement of the travel limiter relative to the tapered tip insert.Attorney Ref. No. A00013528W001BRIEF DESCRIPTION OF THE DRAWINGS

[0011] Figure 1A is a partial cross-sectional view of an abdominal aorta and a side view of a stent graft extending within the abdominal aorta and a prior art delivery system after the stent graft has been released from the delivery system.

[0012] Figure IB is a partial cross-sectional view of the abdominal aorta of Figure 1A and a side of the stent graft and the delivery system of Figure 1A where the delivery system has been advanced relative the stent graft.

[0013] Figure 1C is a partial cross-sectional view of the abdominal aorta of Figure 1 A and a side view of the stent graft and the delivery system of Figure 1 A where the delivery system is in a recaptured state in which a portion of a spindle assembly of the delivery system is recaptured within a tip capture sleeve of the delivery system.

[0014] Figure 2A is a cross-sectional view of a prior art delivery system including a spindle at least partially disposed within a tip capture sleeve in a covered position.|0015] Figure 2B is a cross-sectional view of the prior art delivery system of Figure 2A where the tip capture sleeve is partially extended relative to the spindle in a partially extended position.

[0016] Figure 3 A is a cross-sectional view of a delivery system according to one embodiment where the delivery system includes a spindle partially disposed within a tip capture sleeve in a covered position.

[0017] Figure 3B is a cross-sectional view of the delivery system of Figure 3A where the tip capture sleeve is partially extended relative to the spindle in a partially extended position.

[0018] Figure 4A is a side view of a delivery system where the spindle is partially disposed within the tip capture sleeve in a covered position.

[0019] Figure 4B is a cross-sectional view of the delivery system where the spindle is partially disposed within the tip capture sleeve in the covered position.Attorney Ref. No. A00013528W001100201 Figure 4C is a side view of the delivery system where the tip capture sleeve is advanced to expose the spindle relative to the tip capture sleeve in a partially extended position.

[0021] Figure 4D is a cross-sectional view of the delivery system where the tip capture sleeve is advanced to expose the spindle relative to the tip capture sleeve in the partially extended position.

[0022] Figure 5A is an exploded, side view of the delivery system showing a delivery lumen of the delivery system connected to the spindle assembly, the tip capture sleeve, and a retaining clip.

[0023] Figure 5B is a side view of the delivery system showing the retaining clip placed over the shaft of the travel limiter.

[0024] Figure 5C is a side view of the delivery system showing a tapered tip assembly connecting to the tip capture sleeve to house the travel limiter in a proximal tapered tip insert cavity of the tapered tip assembly.

[0025] Figure 5D is a cross-sectional view of the delivery system taken along line 5D-5D of Figure 5C in a coupled state in which the tapered tip insert threading is mated the tip capture sleeve threading.

[0026] Figure 6 is a schematic, side view of the delivery system of Figure 3 A after releasing a stent graft.

[0027] Figure 7 is a perspective view of a tapered tip insert according to another embodiment.

[0028] Figure 8 is a fragmented, cross-sectional view of a delivery system where a tip capture sleeve is advanced to expose a spindle hub of a spindle assembly relative to the tip capture sleeve in a partially extended position.

[0029] Figures 9A and 9B are cross-sectional and perspective fragmented views of a sleeved loading tool and a spindle hub configured to load a stent into a graft cover.Attorney Ref. No. A00013528W001100301 Figures 9C and 9D are cross-sectional and perspective fragmented views of a tip capture sleeve inserted into a graft cover.[00311 Figures 9E and 9F are cross-sectional and perspective fragmented views of a tapered tip insert inserted into a spindle assembly.

[0032] Figure 9G and 9H are cross-sectional and perspective fragmented views of a tapered tip assembly (including a tapered tip insert) secured to a tapered tip sleeve.DETAILED DESCRIPTION

[0033] 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 basis 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 applications. Various combinations and modifications of the features consistent with the teachings of this disclosure, however, could be desired for particular applications or implementations.

[0034] 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,” “diameter,” “circumference,” etc. also are relative to the central axis. The terms “front,” “rear,” “upper” and “lower” designate directions in the drawings to which reference is made.Attorney Ref. No. A00013528W001|0035| 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 in a 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.

[0036] 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.

[0037] 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 isolating the aneurysm from blood flow. Stent grafts are typically 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 configuration for delivery to the affected vessel site to a radially expanded configuration when deployed at the affected vessel treatment site. The radially expanded configuration has 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 using a balloon catheter, for example.

[0038] In one example, an EVAR procedure may include inserting a guidewire 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 aneurysm. A stent graft delivery system, which may include a catheter and stent graft, may be placed over theAttorney Ref. No. A00013528W001guidewire, and inserted along the guidewire into the site of the aneurysm. The stent graft may be guided within the catheter in its radially compressed configuration to the site of the aneurysm. Radiopaque markers may be located at a distal end of the stent graft delivery system or on the stent graft itself to permit a surgical technician to guide the stent graft into a proper position. Once in the 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. While the delivery systems disclosed herein are described with reference to stent grafts, they may be used for any endovascular / transcatheter device, such as THVs or others.

[0039] Figures 1A, IB, and 1C depict partial cross-sectional views of abdominal aorta 10 and side views of prior art delivery system 12 during different steps of delivery of stent graft 14 via delivery system 12 guided by a clinician. While Figures 1A, IB, and 1C show delivery of stent graft 14 to abdominal aorta 10, stent graft 14 may be delivered to other blood vessels of the patient. Figure 1 A depicts a release step. Figure IB depicts an advancing step. Figure 1C depicts a recapture step.

[0040] Figure 1A shows stent graft 14 released from delivery system 12 and stent graft 14 affixed within abdominal aorta 10 in the vicinity of left renal artery 16 and right renal artery 18. Once affixed within abdominal aorta 10, stent graft 14 is configured to provide a conduit for blood flow through stent graft 14 instead of through aneurysm 20. Blood flowing through stent graft 14 may reduce pressure within aneurysm 20, thereby reducing or stabilizing the size of aneurysm 20.

[0041] Graft material of stent graft 14 may be a non-permeable material, such as polyester terephthalate (PET), expanded polyester terephthalate (ePET), polytetrafluoroethylene (PTFE), polyurethane, or silicone. Blood or other fluid is prevented from passing through the non-permeable graft material. The graft material may also be formed of a natural material such as pericardium or another membranous tissue such as intestinal submucosa. The stents of stent graft 14 may be formed of a radially compressibleAttorney Ref. No. A00013528W001and expandable material configured to self-expand into apposition with the interior wall of abdominal aorta 10. The stent may be coupled to the graft material to support the graft material. The stent may be constructed of stainless steel, a pseudo-elastic metal such as a nickel titanium alloy or nitinol, various polymers, or a super alloy having a base metal of nickel, cobalt, chromium, or other metal. The stent may be formed of a sinusoidal patterned ring including a number of crowns or bends and a number of struts or straight segments with crowns being formed between pairs of opposing struts.

[0042] As shown in Figures 1A-1C, delivery system 12 includes tapered tip assembly 22 including tapered tip 24 and tip capture sleeve 26. Delivery system 12 further includes spindle assembly 28 including post 30 and fin assembly 32. Tapered tip assembly 22 and spindle assembly 28 are connected through spindle lumen 34. As shown in the release and advancing steps of Figures 1 A and IB, respectively, tapered tip assembly 22 and spindle assembly 28 are axially spaced apart from each other by gap region 38. Tapered tip 24 is configured to provide a leading edge to delivery system 12 and to track over one or more guidewires of delivery system 12. Tip capture sleeve 26 proximally extends from tapered tip 24 and defines an internal cavity configured to contain at least a portion of spindle assembly 28 during one or more steps of delivering stent graft 14 to abdominal aorta 10.

[0043] Post 30 and fin assembly 32 of spindle assembly 28 are configured to cooperate to hold a structure (e.g., stent, ring, or loop) at a proximal end of stent graft 14 in a radially compressed configuration during tracking and positioning steps of the delivery process. In this holding configuration, the structure of the proximal end of stent graft 14 is disposed between tip capture sleeve 26 and spindle assembly 28. Once stent graft 14 in its radially compressed configuration is in a proper position within abdominal aorta 10, tapered tip assembly 22 is distally advanced relative spindle assembly 28 to release the proximal end of stent graft 14 from tip capture sleeve 26 and post 30 and fin assembly of spindle assembly 28. Figure 1A depicts stent graft 14 in a radially expanded configuration after stent graft 14 has been released from delivery system 12, and is therefore, referred to as depicting the release step of the delivery process.Attorney Ref. No. A00013528W001|0044| Once stent graft 14 is released from delivery system 12, spindle assembly 28 and gap region 38 are exposed to the anatomy of abdominal aorta 10. The sharp features (e.g., protrusions) included on post 30 and fin assembly 32 of spindle assembly 28 and gap region 38 may complicate removal of delivery system 12 from abdominal aorta 10. In severe cases, these sharp features may displace stent graft 14 from its proper position within abdominal aorta 10 by catching on crowns 36 (e.g., supra-renal crowns) of stent graft 14. The sharp features may also contact and damage the tissue of the wall of abdominal aorta 10.

[0045] As a result of these potential complications, delivery system 12 is advanced in an advancing step as shown in Figure IB where delivery system 12 is advanced relative to stent graft 14 so that the sharp features may then be captured by tip capture sleeve 26. The delivery system 12 may be advanced a relatively long distance (e.g., 3 cm). The advancing step itself may cause potential complications. For instance, the sharp features of spindle assembly 28 and gap region 38 may become stuck on crowns 36 of stent graft 14, thereby making it difficult to advance delivery system 12 relative to stent graft 14. In some instances, advancing delivery system 12 may only be achieved after additional manipulation of delivery system 12.

[0046] As shown in Figure 1C, a portion of spindle assembly 28 including the sharp features and gap region 38 are recaptured within tip capture sleeve 26 by moving tapered tip assembly 22 toward spindle assembly 28 via manipulation of a delivery handle by the clinician (e.g., rotating a back-end wheel of the delivery handle in a counterclockwise direction to recapture spindle assembly 28 within tip capture sleeve 26). The recapture step covers gap region 38 between tapered tip assembly 22 and spindle assembly 28 so that gap region 38 does not catch on stent graft 14, crowns 36, or the anatomy of the patient.

[0047] The post-deployment steps shown in Figures 1A-1C may be utilized to reduce the risk of the complications. While these additional steps reduce risk of the sharp features of spindle assembly 28 or gap region 38 catching on stent graft 14, crowns 36, or the anatomy of the patient, these steps may lengthen and complicate the procedure using delivery system 12, thereby potentially increasing the total radiation exposure to the patient and the clinician. As an additional potential post-deployment complication, withdrawal ofAttorney Ref. No. A00013528W001tapered tip assembly 22 with recaptured spindle assembly 28 may be caught on crowns 36, which may impact the positioning and / or the anchoring of stent graft 14. As yet another potential complication, withdrawal of delivery system 12 and recombination of tapered tip assembly 22 with the graft cover of stent graft 14 may also cause tapered tip assembly 22 to catch on crowns 36.

[0048] Figures 2A is a cross-sectional view of prior art delivery system 50 including spindle 52 at least partially disposed within tip capture sleeve 54 in a covered position. Figure 2B is a cross-sectional view of delivery system 50 where tip capture sleeve 54 is partially extended relative to spindle 52 in a partially extended position. Delivery system 50 is configured to distally advances from the covered position of Figure 2A to the extended position of Figure 2B.

[0049] Spindle 52 defines spindle cavity 56 configured to receive shaft 68. End plate 60 is connected to distal end of spindle 52. Shaft 68 includes stop 62 positioned at the distal end of shaft 68. As shown in Figure 2A, stop 62 contacts the proximal end of spindle cavity 56 in the covered position. As shown in Figure 2B, stop 62 is closer to end plate 60 than the proximal end of spindle cavity 56. In a fully extended position (not shown), stop 62 contacts end plate 60 and prevents further distal movement of tapered tip 76.

[0050] In the covered position shown Figure 2A, stop 62 contacts inner surface 64 of spindle 50 at first contact region 66 and shaft 68 contacts end plate 60 at second contact region 70. In the partially extended position shown in Figure 2B, stop 62 contacts inner surface 64 of spindle 50 at third contact region 72 and shaft 68 contacts end plate 60 at fourth contact region 74. As shown in Figures 2A and 2B, as tapered tip 76 advances, the distance between first and second contact regions 66 and 70 is decreased to the distance between third and fourth contact regions 72 and 74, thereby moving the contact regions (e.g., the contact points) closer together. Drawing the contact points closer together permits articulation between spindle 50 and tip capture sleeve 54 or canting of tapered tip 76 and shaft 68 relative to spindle 52, which may lead to lock up between spindle 52 and tip capture sleeve 54 when a bending moment is applied. A lock up condition may complicate one or more procedural steps of the delivery process (e.g., an advancing step, a recapture step, and / or a recombining step).Attorney Ref. No. A00013528W001[00511 In light of the foregoing, what is needed is a delivery system that modifies or removes one or more of the procedural steps that may lead to complications during the delivery and withdrawal procedure to reduce procedural complexity. The one or more procedural steps may include an advancing step, a recapture step, and / or a recombining step. What is also needed is a delivery system that reduces procedural time and radiation exposure. In one or more embodiments, a delivery system and a delivery method are disclosed to achieve one or more of these objectives.

[0052] Figure 3 A is a cross-sectional view of delivery system 100 according to one embodiment where delivery system 100 includes spindle hub 102 at least partially disposed within tip capture sleeve 104 in a covered position. Figure 3B is a cross-sectional view of delivery system 100 where tip capture sleeve 104 is partially extended relative to spindle hub 102 in a partially extended position.

[0053] Delivery system 100 includes tapered tip 106 and tapered tip insert 108, which may be collectively referred to as tapered tip assembly 110. Tapered tip 106 defines tapered tip lumen 162 that terminates at tapered tip orifice 164. Tapered tip insert 108 has alternating annular projections and grooves at a distal end of tapered tip insert 108. The annular projections include first projection 112A, second projection 112B, third projection 112C, and fourth projection 112D. The annular grooves include first groove 114A, second groove 114B, third groove 114C, and fourth groove 114D. The alternating annular projections and grooves collectively outwardly taper from first projection 112A to fourth groove 114D. In one or more embodiments, tapered tip 106 is overmolded onto tapered tip insert 108 to form complimentary grooves and projections within tapered tip 106 to interlock tapered tip 106 and tapered tip insert 108. Tapered tip insert 108 may be formed of a rigid material such as stainless steel or a polymeric material such as polyether ether ketone (PEEK) or polycarbonate. A medial portion of tapered tip insert 108 includes collar 116, which is configured to mate with the proximal end of tapered tip 106.

[0054] Tapered tip insert 108 defines distal tapered tip insert cavity 118 and proximal tapered tip insert cavity 120, which communicates with tapered tip insert cavity 118. A distal end region of delivery lumen 122 extends within distal tapered tip insert cavity 118 and proximal tapered tip insert cavity 120. Delivery lumen 122 has an outer diameterAttorney Ref. No. A00013528W001that is equal to or substantially equal to the inner diameter of proximal tapered tip insert cavity 120 to couple delivery lumen 122 to proximal tapered tip insert cavity 120. Delivery lumen 122 and proximal tapered tip insert cavity 120 may be mechanically coupled (e.g., press fit or interference fit) and / or chemically coupled (e.g., with an adhesive). In another embodiment, tapered tip assembly 110 is overmolded onto delivery lumen 122. As shown in Figures 3 A and 3B, the central axis of delivery lumen 122 may be aligned with the central axis of proximal tapered insert cavity 120. An outer surface of a medial portion of tapered tip insert 108 includes tapered tip insert threading 124.

[0055] Tip capture sleeve 104 includes distal sleeve portion 126 and proximal sleeve portion 128, and transition portion 130. Transition portion 130 is configured to transition tip capture sleeve 104 from distal sleeve portion 126 to proximal sleeve portion 128. The diameter of distal sleeve portion 126 is greater than the diameter of proximal sleeve portion 128. Tip capture sleeve 104 may be formed of a rigid material to reduce or prevent bending of tip capture sleeve 104. The rigid material may be stainless steel. Distal sleeve portion 126 of tip capture sleeve 104 includes an outer surface having tip capture sleeve threading 132. Tip capture sleeve threading 132 is complimentary to tapered tip insert threading 124 such that tip capture sleeve threading 132 is configured to thread into tapered tip insert threading to mate tip capture sleeve 104 to tapered tip insert 108.

[0056] Delivery system 100 also includes shaft 134, which in combination with spindle hub 102 forms spindle assembly 136. Shaft 134 is integral with spindle hub 102. Shaft 134 may be formed of a rigid material such as stainless steel or PEEK to reduce bending of travel limiter during deployment and delivery. Shaft 134 includes shaft threading 138 on a proximal outer surface region of shaft 134. Spindle hub 102 defines spindle hub cavity 140 having an inner surface including spindle hub cavity threading 142. Shaft 134 also includes collar 144 at a medial region thereof. Shaft threading 138 is complimentary to spindle hub cavity threading 142 such that shaft threading 138 is configured to thread into spindle hub cavity threading 142 to mate shaft 134 to spindle hub 102. In one or more embodiments, the threading motion is stopped by distal end of shaft 134 abutting stop 146 and / or collar 144 abutting stop 148. Shaft 134 mounts to spindle hub 102 to create a rigid inner construction with two spaced apart axial bearing surfaces (e.g., first and second contactAttorney Ref. No. A00013528W001regions 152 and 156) to mitigate lock-up behavior. Spindle hub 102 may be overmolded onto spindle lumen 150.

[0057] In the covered position shown in Figure 3 A, spindle hub 102 contacts (or closely fits to) inner surface of tip capture sleeve 104 at first contact region 152 and stop 154 contacts (or closely fits to) inner surface of proximal tapered tip insert cavity 120 at second contact region 156. In the extended position shown in Figure 3B, spindle hub 102 contacts (or closely fits to) inner surface of tip capture sleeve 104 at third contact region 158 and stop 154 contacts (or closely fits to) inner surface of proximal tapered tip insert cavity 120 at fourth contact region 160. As shown in Figures 3A and 3B, as tapered tip 106 advances, the distance between first and second contact regions 152 and 156 is maintained with the distance between third and fourth contact regions 158 and 160. In one or more embodiments, the distance between contact regions is greater than or equal to the inner diameter of proximal sleeve portion 128 to prevent or reduce the likelihood of a lock up condition and / or complications from angulation. The ratio of the contact region distance to the inner diameter of the proximal sleeve portion is made to be as long as possible with a typical range from 1 : 1 to 2: 1. These ratios may be configured to provide a construction that behaves as a linear bushing and may prevent lock-up and / or may tolerate significant loads trying to create angulation without increasing a sliding force substantially.

[0058] Tip capture sleeve 104 includes radially inwardly projecting flange 184. Radially inwardly projecting flange 184 may extend around the entire circumference of tip capture sleeve 104 or may form a number of spaced apart discrete projections (e.g., 2, 3, 4, 5, 6, 7, or 8, or any subrange therein). Radially inwardly projecting flange 182 is disposed immediately distal (e.g., contacts) collar 144 as shown in Figure 3A. As shown in Figure 3B, radially inwardly projecting flange 182 and stop 154 are close but not contacting each other. Radially inwardly projecting flange 182 contacts stop 154 when tapered tip 106 is fully advanced. As shown in Figures 3 A and 3B, stop 154 has planar proximal surface and radially inwardly projecting flange 182 has planar distal surface. Planar proximal surface and planar distal surface contact each other to stop axially movement of tapered tip assembly 110 when in the fully advanced position.Attorney Ref. No. A00013528W001|0059| Figure 4A is a side view of delivery system 200 where spindle hub 202 is partially disposed within tip capture sleeve 204 in a covered position. Figure 4B is a cross-sectional view of delivery system where spindle hub 202 is partially disposed within tip capture sleeve 204 in the covered position. Figure 4C is a side view of delivery system 200 where tip capture sleeve is advanced to expose spindle hub 202 relative to tip capture sleeve 204 in a partially extended position. Figure 4D is a cross-sectional view of delivery system 200 where tip capture sleeve 204 is advanced to expose spindle hub 202 relative to tip capture sleeve in the partially extended position. Delivery lumen 206 may be coupled (e.g., bonded) to the handle assembly (not shown) of delivery system 200 to prevent or resist tapered tip assembly 208 from unthreading from tip capture sleeve 204 during shipping and / or use of delivery system 200. A travel limiter is configured to prevent or resist detachment of tapered tip assembly 208 in the event of failure of this coupling.

[0060] Tip capture sleeve 204 includes radially inwardly projecting flange 210. Radially inwardly projecting flange 210 may extend around the entire circumference of tip capture sleeve 204 or may form a number of spaced apart discrete projections (e.g., 2, 3, 4, 5, 6, 7, or 8, or any subrange therein). As shown in Figures 4B, 4D, and 5D, retaining clip 212 is disposed between radially inwardly projecting flange 210 and tapered tip insert 214. Retaining clip 212 moves with tapered tip assembly 208 as it advances relative spindle hub 202. Retaining clip 212 contacts stop 216 of shaft 218 when tapered tip assembly 208 is in a fully extended position.[00611 A ratcheting system (not shown) may be included in the handle assembly. The ratcheting system may be configured to prevent tapered tip assembly 208 from retracting once deployed.[0062| As shown in Figure 4C, the outer surface of tip capture sleeve 204 and spindle hub 202 form a curved, regular surface, represented by curved line 220. In one or more embodiments, a regular surface refers to a surface not including any sharp edges, protrusions, ridges, or uneven parts. Spindle hub 202 includes bumps for receiving crowns of a stent graft. The bumps may be circumferentially spaced (e.g., equally spaced) around the peripheral surface of spindle hub 202. The number of bumps may be any number or range between 4 and 10 bumps. These bumps do not include any sharp edges to make theAttorney Ref. No. A00013528W001overall outer surface profile irregular. The regular surface may be smooth and continuous from the distal end of tip capture sleeve 204 to the proximal end of spindle hub 202.

[0063] Figure 5 A is an exploded, side view of delivery system 200 showing delivery lumen 222 connected to spindle assembly 224, tip capture sleeve 204, and retaining clip 212. Retaining clip 212 may be made of a rigid material such as stainless steel or a polymeric material such as PEEK or polycarbonate. As shown in Figure 5A, retaining clip 212 is a C-shaped clip having peripheral body 226 defining central opening 228 and peripheral opening 230. After a stent graft is loaded into a stent cover in a constrained position and the crowns of the stent graft are loaded onto bumps 232 of spindle hub 202, tip capture sleeve 204 is slid over spindle assembly 224 to at least partially (or entirely cover) spindle hub 202 and the crowns of the stent graft. The outer diameters of stop 216 and retaining clip 212 are less than or equal to the distal inner diameter of distal sleeve portion 234. The smallest diameter of tip capture sleeve 204 is the inner diameter of flange 210, which allows stop 216 to pass through but not retaining clip 212.

[0064] Figure 5B is a side view of delivery system 200 showing retaining clip 212 placed over shaft 218. Shaft 218 extends through central opening 228 of retaining clip 212. The outer diameter of shaft 218 is less than the inner diameter of central opening 228 to permit retaining clip 212 to be placed on shaft 218. As shown in Figure 5B, shaft 218 is partially housed within tip capture sleeve cavity 236 defined by tip capture sleeve 204. Retaining clip 212 is placed on shaft 218 adjacent to stop 216.

[0065] Figure 5C is a side view of delivery system 200 showing tapered tip assembly 208 coupled to tip capture sleeve 204 to house stop 216 and shaft 218 in proximal tapered tip insert cavity formed within tapered tip insert 214. Tapered tip insert threading 238 has male threads and tip capture sleeve threading 240 has female threads. In another embodiment, tapered tip insert threading 238 has female threads and tip capture sleeve threading 240 has complimentary male threads. Tapered tip insert threading 238 is screwed into tip capture sleeve threading 240 to form an integral delivery system 200.

[0066] Figure 5D is a cross-sectional view of delivery system 200 taken along line 5D-5D of Figure 5C in a coupled state in which tapered tip insert threading 238 is mated to tip capture sleeve threading 240. The mating operating pushes retaining clip 212 proximallyAttorney Ref. No. A00013528W001until it stops and is captured between radially inwardly projecting flange 210 and proximal end surface 242 of tapered tip insert 214. The capturing of retaining clip 212 is configured to prevent or resist spindle assembly 224 from detaching from tip capture sleeve 204. The outer diameter of retaining clip 212 is greater than or equal to the inner diameter of proximal end surface 242 of tapered tip insert 214. The outer diameter of stop 216 is less than the outer diameter of retaining clip 212. Central opening 228 of retaining clip 212 has an inner diameter greater than an outer diameter of shaft 218.

[0067] In one or more embodiments, delivery system 100 may be deployed within the vasculature of a patient without one or more complicating steps associated with the prior art. After being loaded with a stent graft constrained within a stent graft cover, delivery system 100 is advanced through the vasculature of a patient’s anatomy to a target site. Once at the target site, the stent graft is released from delivery system 100 by advancing tapered tip assembly 110 relative to spindle assembly 136. In one or more embodiments, tapered tip assembly 110 is advanced along with tip capture sleeve 104 until the proximal end of tip capture sleeve 104 aligns with a target line to represent release of the stent graft. After release of the stent graft, delivery system 100 is withdrawn without advancing the delivery system and recapturing spindle assembly 136. As shown in Figure 6, the elimination of these steps is supported by the regular surface of the extended spindle assembly 136 and tip capture sleeve 104 resisting or preventing the crowns of the stent graft from being disturbed.

[0068] Figure 7 is a perspective view of tapered tip insert 700 according to another embodiment. Tapered tip insert 700 includes distal portion 704 and proximal portion 706. Tapered tip insert 700 may be formed of a polymeric material such as polyether ketone (PEEK) or polycarbonate using a molding process (e.g., injection molding process). As shown in Figure 7, core pin 702 used in an injection molding process to fabricate tapered tip inert 700 is in a removed position relative to tapered tip insert 700. The outer surface of core pin 702 partially follows the contour of the inner surface of proximal portion 706.

[0069] Distal portion 704 of tapered tip insert 700 includes annular projections and grooves. The annual projections include first projection 708A, second projection 708B, and third projection 708C. The annular grooves include first groove 710A, second groove 710B, and third groove 710C. The alternating annular projections and grooves collectivelyAttorney Ref. No. A00013528W001outwardly taper from first projection 708 A to third groove 710C. A tapered tip may be overmolded onto tapered tip insert 700 to form complimentary grooves and projections within the tapered tip to interlock the tapered tip to tapered tip insert 700. A medial portion of tapered tip insert 700 includes collar 712, which is configured to mate with a proximal end of the tapered tip.

[0070] Proximal portion 706 of tapered tip insert 700 includes threading 714 (e.g., male threading) and tabs 716A, 716B, 716C, and 716D. Tabs 716A, 716B, 716C, and 716D may be collectively referred to as tabs 716. As shown in Figure 7, tabs 716A, 716B, 716C, and 716D have circumferentially, curved shapes and may lie in a common imaginary cylindrical plane extending from threading 714. Tabs 716A, 716B, 716C, and 716D inwardly taper in an axial direction from a distal end to a proximal end such that a width of the tabs 716 is smaller at their proximal end than at their distal end. Adj acent tabs are spaced apart from each other to form circumferential notches therebetween. As shown in Figure 7, each of the notches has a V-shaped profile, which may allow for the use of a two-piece molding apparatus. Opposing walls of the V-shaped profile terminate at a curved valley. A gap is formed between each tab 716, which widens in a proximal direction as the tabs 716 taper. Tabs 716A, 716B, 716C, and 716D form proximal cavity 718. Tabs 716A, 716B, 716C, and 716D are configured for inward and outward flex while retaining their shape at rest. In one or more embodiments, tabs 716A, 716B, 716C, and 716D may have inner ridges for structural support. Tabs 716A, 716B, 716C, and 716D are equally circumferentially spaced at positions of 0 degrees, 90 degrees, 180 degrees, and 270 degrees. In other embodiments, the circumferential spacing may be unequally spaced. Each of the tabs 716A, 716B, 716C, and 716D may occupy 90 degrees or less of the circumferential space of proximal portion 706. While four (4) tabs are shown in Figure 7, in other embodiments, a different number of tabs may be utilized, for example, 2, 3, 5, 6, 7, 8, 9, and 10, with the equal spacing and occupied location of each tab being 360 degrees divided by the number of tabs.

[0071] While description will now be set forth for representative tab 716C, such description may apply to other tabs 716A, 716B, and 716D. Representative tab 716C includes distal ramp 720, proximal ramp 722, and medial surface 724 axially extending between distal ramp 720 and proximal ramp 722. Distal ramp 720 tapers outwardly fromAttorney Ref. No. A00013528W001medial surface 724 to inner surface 728 of tab 716. Proximal ramp 722 terminates at proximal edge surface 726. Proximal ramp 722 tapers outwardly from medial surface 724 to proximal edge surface 726. Distal ramp 720 extends inwardly from inner surface 728 of tab 716C to medial surface 724.

[0072] Tapered tip insert 700 may be formed around core pin 702 to form proximal cavity 718 during a molding process. Core pin 702 may be removed from proximal cavity 718 after the molding process is completed by withdrawing core pin 702 from proximal cavity 718. Core pin 702 rides on distal ramp 720 and tabs 716A, 716B, 716C, and 716D flex outwardly during removal of core pin 702.

[0073] Figure 8 is a fragmented, cross-sectional view of delivery system 800 where tip capture sleeve 802 is advanced to expose spindle hub 804 of spindle assembly 816 relative to tip capture sleeve 802 in a partially extended position. Delivery lumen 806 may be coupled (e,g., bonded) to the handle assembly (not shown) of delivery system 800 to prevent or resist tapered tip assembly 808 from unthreading from tip capture sleeve 802 during shipping and / or use of delivery system 800. Travel limiter 810 is configured to prevent or resist detachment of tapered tip assembly 808 in the event of failure of this coupling.

[0074] Tabs 716A, 716B, 716C, and 716D are configured to flex outward around stop 812 of travel limiter 810. Tabs 716A, 716B, 716C, and 716D are an example of a retainer configured to retain a portion of travel limiter 810. Stop 812 rides on proximal ramps 722 during assembly of the travel limiter 810 to tapered tip insert 700 such that stop 812 may locate within proximal cavity 718 through further axial movement. This operation of the assembly process may take place before tip capture sleeve 802 is secured to tapered tip insert 700. Once tip capture sleeve 802 is secured to tapered tip insert 700, inner surface 814 of tip capture sleeve 802 resists or prevents tabs 716A, 716B, 716C, and 716D from flexing outward, thereby resisting stop 812 from riding on distal ramp 720 and out of proximal cavity 718.

[0075] Figures 9A and 9B are cross-sectional and perspective fragmented views of sleeved loading tool 900 and spindle hub 804 configured to a load stent into graft cover 904. Loading tool 900 includes flanged retainer 906 configured to engage stop 812 of travelAttorney Ref. No. A00013528W001limiter 810 during the loading step of the assembly process. Distal end of graft cover 904 overlaps with proximal end of loading tool 900 during the loading step of the assembly process.

[0076] Figures 9C and 9D are cross-sectional and perspective fragmented views of tip capture sleeve 802 inserted into graft cover 904. At this step in the assembly process, loading tool 900 has been removed from graft cover 904 and has been replaced with tip capture sleeve 802. A proximal portion of tip capture sleeve 802 is nested within a distal portion of graft cover 904.

[0077] Figures 9E and 9F are cross-sectional and perspective fragmented views of tapered tip insert 700 inserted into spindle assembly 816. Figures 9E and 9F further depict tabs 716 clipped over travel limiter 810 of spindle assembly 816. Tabs 716 may become clipped over stop 812 of travel limiter 810 by outward flexing of tabs 716. As shown in Figures 9E and 9F, stop 812 is located within proximal cavity 718 of tapered tip insert 700.

[0078] Figures 9G and 9H are cross-sectional and perspective fragmented views of tapered tip assembly 808 (including tapered tip insert 700) secured to tip capture sleeve 802. Tapered tip assembly 808 is secured to tapered tip sleeve 802 through complimentary screw threads on tapered tip insert 700 (e.g., threading 714 in Figure 7) and tapered capture sleeve 802 (e.g., threading 902 in Figure 9C).

[0079] Tapered tip assembly 808 secured to tapered tip sleeve 802, as shown in Figures 9G and 9H, which may be generally referred to as part of a tip capture mechanism, are tracked through a patient’s vasculature to a target location in the patient’s vasculature. Once at the target location, graft cover 904 is retracted to allow the stent graft to expand and then the distal tip of tapered tip assembly 808 is advanced to release a captured bare stent of the stent graft from the tip capture mechanism. The travel of the distal tip of tapered tip assembly is limited by the interaction of tabs 716 and stop 812 with inner surface 814 of tapered tip sleeve 802 preventing tabs 716 from flexing out as shown, for example, as shown in Figure 8. Beneficially, a continuous atraumatic surface is created that does not require recapturing of the tip within the graft cover.Attorney Ref. No. A00013528W001

[0080] 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.

[0081] The following examples are illustrative of the techniques described herein.

[0082] Example 1. A tapered tip endovascular delivery system for delivering an endovascular implant within a blood vessel, the tapered tip endovascular delivery system comprising: a tip assembly including a tapered tip and a tip capture sleeve, the tapered tip includes a tapered tip insert; and a spindle assembly including a spindle hub and a travel limiter, the tip assembly is configured to axially advance relative the spindle assembly between a covered position in which the spindle hub is at least partially disposed within the tip capture sleeve and an extended position in which the spindle hub is at least partially extended outside of the tip capture sleeve, the tapered tip insert includes a distal portion and a proximal portion including a retainer configured to retain a portion of the travel limiter in a retained position.

[0083] Example 2. The tapered tip endovascular delivery system of Example 1, wherein the retainer includes a plurality of tabs configured to retain the portion of the travel limiter in the retained position.Attorney Ref. No. A00013528W001

[0084] Example 3. The tapered tip endovascular delivery system of Example 2, wherein the plurality of tabs include two or more tabs.

[0085] Example 4. The tapered tip endovascular delivery system of Example 3, wherein each pair of adjacent tabs of the two or more tabs form notch(es).

[0086] Example 5. The tapered tip endovascular delivery system of Example 4, wherein the notch(es) are v-shaped notch(es).(0087] Example 6. The tapered tip endovascular delivery system of Example 2, wherein each tab of the plurality tabs includes a proximal ramp configured to receive the portion of the travel limiter through axial movement of the travel limiter relative the proximal portion of the tapered tip insert.

[0088] Example 7. The tapered tip endovascular delivery system of Example 6, wherein each tab of the plurality of tabs are configured to flex outward to receive the travel limiter.

[0089] Example 8. The tapered tip endovascular delivery system of Example 2, wherein the plurality of tabs forms a proximal cavity configured to receive the portion of the travel limiter.

[0090] Example 9. The tapered tip endovascular delivery system of Example 2, wherein each of the tabs of the plurality of tabs have circumferentially curved shape(s).

[0091] Example 10. The tapered tip endovascular delivery system of Example 2, wherein each of the tabs of the plurality of tabs has a tapered profile in a radial, circumferential direction of the tapered tip insert.

[0092] Example 11. The tapered tip endovascular delivery system of Example 1, wherein the retainer forms an open proximal end configured to receive the portion of the travel limiter.

[0093] Example 12. A tapered tip endovascular delivery system for delivering an endovascular implant within a blood vessel, the tapered tip endovascular delivery system comprising: a tip assembly including a tapered tip and a tip capture sleeve, the tapered tipAttorney Ref. No. A00013528W001includes a tapered tip insert; and a spindle assembly including a spindle hub and a travel limiter, the tip assembly is configured to axially advance relative the spindle assembly between a covered position in which the spindle hub is at least partially disposed within the tip capture sleeve and an extended position in which the spindle hub is at least partially extended outside of the tip capture sleeve, the tapered tip insert includes a distal portion and a proximal portion, the proximal portion includes a retainer configured to retain a portion of the travel limiter in a retained position in which the tip capture sleeve is configured to reduce or prevent outward flexing of the retainer.

[0094] Example 13. The tapered tip endovascular delivery system of Example 12, wherein the tip capture sleeve includes an inner surface, the retainer bears against the inner surface of the tip capture sleeve in the retained position.

[0095] Example 14. The tapered tip endovascular delivery system of Example 13, wherein the inner surface is disposed in a medial axial portion of the tip capture sleeve.

[0096] Example 15. The tapered tip endovascular delivery system of Example 12, wherein the retainer includes a plurality of tabs configured to retain the portion of the travel limiter in the retained position.

[0097] Example 16. A method of assembling a tapered tip endovascular delivery system, the method comprising: axially advancing a spindle assembly relative to a tapered tip insert, the spindle assembly includes a spindle hub and a travel limiter extending from the spindle hub, the tapered tip insert includes a proximal retainer; and outwardly flexing the proximal retainer to receive the portion of a travel limiter within the tapered tip insert.

[0098] Example 17. The method of Example 16 further comprising retaining the portion of the travel limiter within a proximal cavity formed by the proximal retainer.

[0099] Example 18. The method of Example 17 further comprising retaining the tapered tip insert with a tip capture sleeve to limit or prevent flexing of the proximal retainer.

[0100] Example 19. The method of Example 18, wherein the securing step occurs after the retaining step.Attorney Ref. No. A00013528W001|01011 Example 20. The method of Example 16, wherein the proximal retainer includes a plurality of tabs configured to retain the portion of the travel limiter in a retained position, each tab of the plurality tabs includes proximal ramp configured to receive the portion of the travel limiter through axial advancement of the travel limiter relative to the tapered tip insert.

Claims

Attorney Ref. No. A00013528W001WHAT IS CLAIMED IS:

1. A tapered tip endovascular delivery system (100) for delivering an endovascular implant within a blood vessel, the tapered tip endovascular delivery system comprising:a tip assembly (110) including a tapered tip (106) and a tip capture sleeve (802), the tapered tip includes a tapered tip insert (700); anda spindle assembly (816) including a spindle hub (804) and a travel limiter (810), the tip assembly is configured to axially advance relative the spindle assembly between a covered position in which the spindle hub is at least partially disposed within the tip capture sleeve and an extended position in which the spindle hub is at least partially extended outside of the tip capture sleeve,the tapered tip insert includes a distal portion (704) and a proximal portion (706) including a retainer (716) configured to retain a portion of the travel limiter in a retained position.

2. The tapered tip endovascular delivery system of claim 1, wherein the retainer includes a plurality of tabs (706A, 706B, 706C, and / or 706D) configured to retain the portion of the travel limiter in the retained position.

3. The tapered tip endovascular delivery system of claim 2, wherein the plurality of tabs include two or more tabs.

4. The tapered tip endovascular delivery system of claim 3, wherein each pair of adjacent tabs of the two or more tabs form notch(es).

5. The tapered tip endovascular delivery system of claim 4, wherein the notch(es) are v-shaped notch(es).

6. The tapered tip endovascular delivery system of claim 2, wherein each tab of the plurality tabs includes a proximal ramp (706) configured to receive the portion of the travel limiter through axial movement of the travel limiter relative the proximal portion of the tapered tip insert.Attorney Ref. No. A00013528W0017. The tapered tip endovascular delivery system of claim 6, wherein each tab of the plurality of tabs are configured to flex outward to receive the travel limiter.

8. The tapered tip endovascular delivery system of claim 2, wherein the plurality of tabs forms a proximal cavity (718) configured to receive the portion of the travel limiter.

9. The tapered tip endovascular delivery system of claim 2, wherein each of the tabs of the plurality of tabs have circumferentially curved shape(s).

10. The tapered tip endovascular delivery system of claim 2, wherein each of the tabs of the plurality of tabs has a tapered profile in a radial, circumferential direction of the tapered tip insert.

11. The tapered tip endovascular delivery system of claim 1, wherein the retainer forms an open proximal end configured to receive the portion of the travel limiter.

12. The tapered tip endovascular delivery system of claim 1, wherein the tip capture sleeve is configured to reduce or prevent outward flexing of the retainer.

13. The tapered tip endovascular delivery system of claim 12, wherein the tip capture sleeve includes an inner surface, the retainer bears against the inner surface of the tip capture sleeve in the retained position.

14. The tapered tip endovascular delivery system of claim 13, wherein the inner surface is disposed in a medial axial portion of the tip capture sleeve.

15. The tapered tip endovascular delivery system of claim 12, wherein the retainer includes a plurality of tabs configured to retain the portion of the travel limiter in the retained position.

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