US-20260124053-A1 - RELEASABLE GUIDE MEMBERS FOR PRE-CANNULATING BRANCHED STENT GRAFT DELIVERY

US20260124053A1US 20260124053 A1US20260124053 A1US 20260124053A1US-20260124053-A1

Abstract

A delivery system for an implantable device includes an elongate member and a main body coupled to the elongate member. The main body has a main body wall defining a main body lumen and a side branch portal through the main body wall. A guide member extends along at least a portion of the elongate member, into the main body lumen, and through the side branch portal. A guide member retainer assembly includes a retainer coupled to the guide member and defining a retainer eyelet. A release wire extends through a portion of the main body wall and the retainer eyelet to engage the retainer eyelet, restricting the guide member from being retracted along the elongate member by the engagement between the release wire and the retainer eyelet.

Inventors

Michael R. Broyles
Daniel S. Cole
Michael J. Shepard

Assignees

W. L. GORE & ASSOCIATES, INC.

Dates

Publication Date: 20260507
Application Date: 20251103

Claims (20)

1 . A delivery system for an implantable device, comprising: an elongate member; a main body coupled to the elongate member, the main body including a main body wall defining a main body lumen and a side branch portal through the main body wall; a guide member extending along at least a portion of the elongate member, into the main body lumen, and through the side branch portal; a guide member retainer assembly including: a retainer coupled to the guide member and defining a retainer eyelet; and a release wire extending through a portion of the main body wall and the retainer eyelet to engage the retainer eyelet such that the guide member is restricted from being retracted along the elongate member by the engagement between the release wire with the retainer eyelet.
2 . The delivery system of claim 1 , wherein the retainer is defined at a proximal end of the guide member.
3 . The delivery system of claim 2 , wherein the retainer eyelet is defined through a body of the proximal end of the guide member.
4 . The delivery system of claim 1 , wherein the guide member retainer assembly includes a plurality of retainers arranged in a nested configuration.
5 . The delivery system of claim 4 , wherein the plurality of retainers are positioned at different longitudinal positions along the release wire.
6 . The delivery system of claim 5 , wherein the plurality of retainers are positioned relative to each other to distribute multiple guide members in a manner that corresponds to longitudinal and angular positioning of multiple side branch portals in the main body.
7 . The delivery system of claim 1 , wherein the retainer has a thinner profile than a remainder of the guide member.
8 . A delivery system for an implantable device, comprising: an elongate member; a main body positioned about the elongate member, the main body including a frame; a guide member extending along at least a portion of the elongate member; a guide member retainer assembly releasably coupling the guide member to the frame, the guide member retainer assembly including: a retainer coupled to the guide member and defining a side wall opening; and a release wire extending through the guide member and the side wall opening such that the frame is positioned between the guide member and the release wire at the side wall opening to releasably couple the guide member to the frame.
9 . The delivery system of claim 8 , wherein the retainer comprises a proximal hypotube coupled to a proximal end of the guide member.
10 . The delivery system of claim 9 , wherein the retainer further comprises a second proximal hypotube positioned within the proximal hypotube, the proximal hypotube and the second proximal hypotube configured to translate relative to each other to release the frame.
11 . The delivery system of claim 9 , wherein the retainer further comprises a first side wall opening and a second side wall opening positioned along a length of the proximal hypotube, wherein a frame retainer groove is formed between the first and second side wall openings.
12 . The delivery system of claim 11 , wherein the release wire extends through the guide member, out the first side wall opening, and back into the second side wall opening to secure the frame in the frame retainer groove.
13 . The delivery system of claim 12 , wherein the retainer further comprises a loop coupled to the proximal hypotube, the loop including a retainer ball, wherein the proximal hypotube includes a sidewall aperture configured to receive the retainer ball, and wherein the release wire engages the retainer ball to secure the frame until the release wire is withdrawn.
14 . The delivery system of claim 9 , wherein the proximal hypotube further comprises retainer protrusions extending partially into the side wall opening, the retainer protrusions configured to flex to allow passage of the release wire through the side wall opening when a threshold force is applied.
15 . A delivery system for an implantable device, comprising: an elongate member; a main body positioned about the elongate member, the main body including a frame and defining a side branch member; a guide member positioned through the side branch member in a pre-cannulated configuration; a guide member retainer assembly releasably coupling the guide member to the frame, the guide member retainer assembly including: a proximal hypotube including a slot and a retention tab; and a release wire extending through the proximal hypotube, the release wire including a portion protruding from the slot and a groove engaged by the retention tab.
16 . The delivery system of claim 15 , further comprising a disengagement tube configured to disengage the retention tab from the groove when advanced proximally, allowing the release wire to be withdrawn to release the frame.
17 . The delivery system of claim 16 , wherein the retention tab bends inwardly to define a ramp surface.
18 . The delivery system of claim 17 , wherein the disengagement tube is configured to translate along the ramp surface and deflect the retention tab away from the groove to release the release wire from its longitudinally constrained position relative to the proximal hypotube.
19 . The delivery system of claim 15 , wherein the release wire includes a proximal end that is constrained by the proximal hypotube when the retention tab is engaged with the groove, and wherein withdrawal of the release wire results in the proximal end being freed from the proximal hypotube.
20 . The delivery system of claim 15 , wherein the curved portion is configured to engage with the frame when the retention tab is engaged with the groove, and wherein advancement of the disengagement tube causes progressive disengagement of the retention tab from the groove to allow withdrawal of the release wire and release of the frame from the guide member retainer assembly.

Description

CROSS-REFERENCE TO RELATED APPLICATION This application claims the benefit of Provisional Application No. 63/837,314, filed Jul. 2, 2025, and also claims the benefit of Provisional Application No. 63/716,035, filed Nov. 4, 2024, which are incorporated herein by reference in their entireties for all purposes. FIELD The present disclosure relates to delivery systems for implantable medical devices, and more particularly to a delivery system for deploying a branched stent graft with independently releasable guide members for pre-cannulating side branch portals. BACKGROUND A variety of branched, anatomical passages may benefit from treatment in the form of an implanted, endoluminal device. One such passage is a vascular passage, such as an artery, with an aneurysm. Aortic disease and trauma such as aneurysms and dissections present a significant risk to a patient. That risk is increased based on the patient's condition. Such conditions or factors can include the patient's age and preexisting and/or related conditions such as cardiopulmonary bypass, cardiac arrest, circulatory arrest. These and other factors may limit the patient's ability to withstand and recover from surgery to repair the aortic disease. This same issue exists in other diseased and damaged tissues in the patients. With respect to aneurysms, in order to prevent rupturing of an aneurysm, a stent graft may be introduced into a blood vessel percutaneously and deployed to span the aneurysmal sac. Stent grafts include a graft fabric secured to a cylindrical scaffolding or framework of one or more stents. The stent(s) provide rigidity and structure to hold the graft open in a tubular configuration as well as the outward radial force needed to create a seal between the graft and a healthy portion of the vessel wall and provide migration resistance. Blood flowing through the vessel can be channeled through the luminal surface of the stent graft to reduce, if not eliminate, the stress on the vessel wall at the location of the aneurysmal sac. Stent grafts may reduce the risk of rupture of the blood vessel wall at the aneurysmal site and allow blood to flow through the vessel without interruption. Various endovascular repair procedures such as the exclusion of an aneurysm require a stent graft to be implanted adjacent to a vascular bifurcation. Often the aneurysm extends into the bifurcation requiring the stent graft to be placed into the bifurcation. A bifurcated stent graft is therefore required in these cases. Modular stent grafts, having a separate main body and branch component are often preferred in these procedures due to the ease and accuracy of deployment. See U.S. Patent Application No. 2008/0114446 to Hartley et al. for an example of a modular stent graft having separate main body and branch stent components. In the Hartley et al. publication the main body stent has a fenestration in the side wall that is tailored to engage and secure the side branch stent. However, delivery and deployment of side branches through a main body can be difficult. For example, delivering side branch devices through the appropriate openings in the main body and into the appropriate side branch vessel can be difficult in endovascular procedures. Additionally, management of wires for delivering branch stent components to the target site can be difficult as the wires can become entangled during delivery. Additionally, the wires can be obstructive of procedures and movements during delivery and deployment of the devices. SUMMARY This summary is provided to introduce a selection of concepts in a simplified form that are further described below in the detailed description. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used as an aid in determining the scope of the claimed subject matter. According to an example (“Example 1”), a delivery system for an implantable device includes an elongate member, a main body coupled to the elongate member, a guide member, and a guide member retainer assembly. The main body includes a main body wall defining a main body lumen and a side branch portal through the main body wall. The guide member extends along at least a portion of the elongate member, into the main body lumen, and through the side branch portal. The guide member retainer assembly includes a retainer coupled to the guide member and defining a retainer eyelet, and a release wire extending through a portion of the main body wall and the retainer eyelet to engage the retainer eyelet such that the guide member is restricted from being retracted along the elongate member by the engagement between the release wire with the retainer eyelet. According to another example (“Example 2”), further to Example 1, the retainer is defined at a proximal end of the guide member. According to another example (“Example 3”), further to Example 2, the retainer eyelet is defined through a body of the proximal end