The present disclosure relates generally to an endovascular stent graft (e.g., a branched stent graft) having a gate with a joining liner joining an implant to the gate. The joining liner may be joined to an internal surface of the gate.
Endovascular procedures are minimally invasive techniques delivering clinical treatments and repairs to a patient's vasculature. A stent graft is an implantable device used in endovascular procedures. The stent graft includes a tube-shaped surgical graft and an expanding stent frame. The stent graft may be placed inside a blood vessel to bridge a diseased segment of the blood vessel (e.g., an aneurismal, dissected, or torn segment of the blood vessel). The stent graft is configured to exclude hemodynamic pressures of blood flow from the diseased segment of the blood vessel.
Depending on the region of the aorta involved, the diseased segment may extend into vessel bifurcations or segments (otherwise referred to as branches) of the aorta. Thoracic aortic aneurysms are examples of diseased segments that may present in the ascending thoracic aorta, the aortic arch, and/or branch arteries (e.g., left subclavian, left common carotid, or the brachiocephalic arteries). In some cases, a branched stent graft can be used to treat such aneurysms. For example, a branched stent graft can be deployed in the main vessel (e.g., aortic arch) with a branch extending therefrom and toward or into the branched artery (e.g., left subclavian), and a supplemental, secondary stent graft can be deployed in the branched artery and connected to the branch. In other applications, a branched stent graft may also include branch and tributary legs for extending the branched stent graft into other blood vessels branching from the aorta (e.g., renal, celiac, or mesenteric arteries).
According to one embodiment, an endovascular stent graft is disclosed. The endovascular stent graft includes a body including a gate having an internal surface, a joining liner joined to the internal surface of the gate with a joint and having a bunched state and a crumpled state, and an implant at least partially disposed within the joining liner and having a radially compressed state and a radially expanded state. The implant in the radially expanded state exerts a radial force on the joining liner to maintain the joining liner in the crumpled state.
According to another embodiment, an endovascular stent graft is disclosed. The endovascular stent graft includes a body including a gate having an internal surface and a joining liner joined to the internal surface of the gate with a distal joint and a proximal joint. At least one of the distal and proximal joints extend around at least one of distal and proximal circumferences, respectively, of the gate. The endovascular stent graft also includes an implant at least partially disposed within the joining liner and having a radially compressed state and a radially expanded state. The implant in the radially expanded state contacts the joining liner.
According to yet another embodiment, a method for joining an implant with a gate of an endovascular stent graft is disclosed. The method includes the step of inserting the implant in a radially compressed state into the gate having an internal joining liner having a bunched state and a crumpled state. The method further includes translating the implant from the radially compressed state into a radially expanded state to exert a radial force on the joining liner to maintain the joining liner in the crumpled state and to form a joint between the implant and the joining liner of the gate.
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.
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.
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.
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 (e.g., aortic valves, heart ventricles, and heart walls) where it is deemed useful.
Branched stent graft 10 includes main body 12 extending between proximal end 14 and distal end 16. Branched stent graft 10 also includes first leg 18 extending between proximal end 20 and distal end 22, and second leg 24 extending between proximal end 26 and distal end 28. Proximal end 20 of first leg 18 is joined with distal end 16 of main body 12 with first seam 30. Proximal end 26 of second leg 24 is joined with distal end 16 of main body 12 with second seam 32. First leg 18 defines first opening 34 at first gate 36, which refers to a distal portion of first leg 18. Second leg 24 defines second opening 38 at second gate 40, which refers to a distal portion of second leg 24. Second gate 40 may be a contralateral gate and branched stent graft 10 may be a bifurcated stent graft.
Joining liner 42 may be formed of a semi-permeable material or a non-permeable material. A non-limiting example of a semi-permeable material is woven polyester terephthalate (PET). Non-limiting examples of non-permeable material include polyester terephthalate (PET), expanded polyester terephthalate (ePET), polytetrafluoroethylene (PTFE), and combinations thereof. Joining liner 42 may be a woven textile material. Joining liner 42 may be formed of a polymeric material using a forming process (e.g., extrusion process or an electro-spinning process). The material forming joining liner 42 may be the same or may be different than the material forming graft material 11 of branched stent graft 10. The material of joining liner 42 may have different material properties (e.g., greater flexibility and/or less strength) than the material forming second gate 40 because of the different functions performed by the two materials. The material of liner 42 may be configured to reduce or eliminate leak paths between implant 60 while the material of second gate 40 may be stronger to exclude hemodynamic pressures of blood flow from a diseased segment of a blood vessel. In one or more embodiments, the material forming joining liner 42 may be less expensive than the material forming second gate 42.
Proximal and/or distal joints 56 and/or 58 may be formed of stitching and/or sutures formed of a textile material or a polymeric material. In another embodiment, proximal and/or distal joints 56 and/or 58 may be formed of a melted and solidified mixture of a portion of graft material 11 of branched stent graft 10 and joining liner 42. The melted/solidified mixture joint may be applicable when joining liner 42 is formed of a polymeric material. The joints may also be formed of adhesives, staples, or any other joining mechanism. In one or more embodiments, both joints may extend continuously around the entire circumference of second gate 40 to create a seal between joining liner 42 and the graft material of second gate 40. In other embodiments, only one of the joints extend continuously around the entire circumference of second gate 40.
As shown in
As shown in
Joining liner 42 is configured to reduce leakage through joint 68 formed between implant 60 and second gate 40 when joining liner 42 is in crumpled state 66 and implant 60 is in radially expanded state 64. Joining liner 42 in crumpled state 66 does not significantly reduce volume of the lumen formed by second gate 40 such that the flow of blood or other fluids is not significantly reduced after the implant 60 is deployed within second gate 40. Joining liner 42 is configured to increase the strength and migration resistance of joint 68 between second gate 40 and implant 60. In one or more embodiments, the structural integrity of joining liner 42 may be less than the structural integrity of the graft material of second gate 40 because the primary function of joining liner 42 is a filler to reduce leakage paths, increase joint strength, and/or increase migration resistance whereas the graft material of second gate 40 imparts structural integrity to branched stent graft 10.
Joining liner 42 may improve endurance reliability by creating a buffer between implant 60 and second gate 42 to achieve leakage reductions, strength increases, and/or migration resistance without additional attachment mechanisms, stents, and/or sponges. Joining liner 42 may also reduce packaging density using a lower cost material with less structural integrity as opposed to additional attachment mechanisms, stents, and/or sponges.
In one or more embodiments, the joining liner may be bunched along a circumference of the gate.
Branched stent graft 100 includes main body 102 extending between proximal end 104 and distal end 106. Branched stent graft 100 also includes coupling 108. Coupling 108 may be a branching gate of a thoracic stent graft (e.g., branched stent graft 100). Coupling 108 may be positioned such that when branched stent graft 100 is deployed, coupling 108 is aligned with and extends into the left subclavian artery. In other embodiments, coupling 108 may be located on branched stent graft 100 to align with and extend into other branches of the aorta such as the brachiocephalic artery, the left common carotid artery, a renal artery, the celiac artery, or the SMA. Coupling 108 tapers inwardly from wide proximal end 110 to narrow distal end 112. Coupling 108 defines opening 114 at branching gate 116, which refers to a distal portion of coupling 108.
Proximal joint 132 may be formed of stitching and/or sutures formed of a textile material or a polymeric material. In another embodiment, proximal joint may be formed of a melted and solidified mixture of a portion of graft material 101 of branched stent graft 100 and joining liner 118. The joints may also be formed of adhesives, staples, or other joining mechanisms. As shown in
As shown in
Joining liner 118 is configured to reduce leakage through joint 148 formed between implant 140 and branching gate 116 when joining liner 118 is in crumpled state 146 and implant 140 is in radially expanded state 64. When branching gate 116 and implant 140 have tapered shapes (e.g., conical shapes), inaccuracy in deployment (e.g., proximal deployment) of implant 140 within branching gate 116 may result in additional leakage paths reducing seal performance. Joining liner 118 is beneficial in reducing or eliminating such leakage paths. Utilizing a joining liner such as joining liner 118 enables proper alignment between the tapered shapes of branching gate 116 and implant 140 such that proximal ends 150 and 152 of branching gate 116 and implant 140, respectively, align as shown in
Joining liner 118 in crumpled state 146 does not significantly reduce volume of the lumen formed by branching gate 116 such that the flow of blood or other fluids is not significantly reduced after the implant 140 is deployed within branching gate 116. Joining liner 118 is configured to increase the strength and migration resistance of joint 148 between branching gate 116 and implant 140. In one or more embodiments, the structural integrity of joining liner 118 may be less than the structural integrity of the graft material of branching gate 116 because the primary function of joining liner 118 is a filler to reduce leakage paths, increase joint strength, and/or increase migration resistance whereas the graft material of branching gate 116 imparts structural integrity to branched stent graft 100.
Joining liner 118 may improve endurance reliability by creating a buffer between implant 140 and branching gate 116 to achieve leakage reductions, strength increases, and/or migration resistance. Joining liner 118 may also reduce packaging density using a lower cost material with less structural integrity as opposed to additional attachment mechanisms, stents, and/or sponges.
The joining liners of one or more embodiments may be suitable for complex stent graft systems used within branching vessel that utilize a branching lumen with reduced leakage, migrations, and fatigue by accommodating a wider range of non-uniform implants or short joint lengths. The joining liners of one or more embodiments may improve the joint connection reliability.
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.
This application claims the benefit of U.S. provisional application Ser. No. 63/311,237 filed Feb. 17, 2022, the disclosure of which is hereby incorporated in its entirety by reference.
Number | Date | Country | |
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63311237 | Feb 2022 | US |