Modular multi-branch support assembly and method

Abstract

This disclosure generally relates to a modular stent device comprising a main body configured to deploy in the ascending aorta, a bypass valve configured to deploy in the aorta, and a bifurcated contralateral branch. The bifurcated contralateral branch includes a single proximal branch that bifurcates (diversifies) into a first distal branch and a second distal branch. By forming the bifurcated contralateral branch as a single proximal branch that bifurcates into the distal branch, guiding a guide wire proximally into the relatively larger opening of the bifurcated contralateral branch is simpler than guiding a guide wire into two smaller branches extending distally from the main body. Therefore, cannulation of the bifurcated contralateral branch is relatively simple, thus simplifying the procedure. Furthermore, the parallel design mimics anatomical vascular bifurcation to limit flow interruption.

Description

Technical Field

[0001] This invention generally relates to intravascular devices and methods. More specifically, this application relates to devices for treating intravascular diseases. Background Technology

[0002] Aneurysms, dissections, penetrating ulcers, intramural hematomas, and / or transverse severances can occur in blood vessels, and most typically in the aorta and peripheral arteries. Aortic involvement can extend to areas with bifurcations or aortic segments, with smaller “branch” arteries extending from the bifurcation.

[0003] The diseased area of ​​the aorta can be bypassed by using a stent graft placed inside a blood vessel that crosses the diseased section of the aorta, thus sealing off the diseased section from further exposure to the blood flowing through the aorta.

[0004] Using a stent graft to bypass a diseased portion of the aorta internally is not without its challenges. Specifically, care must be taken to ensure that critical branch arteries are not covered or blocked by the stent graft, which must be sealed against the aortic wall and provide a flow channel for blood to pass through the diseased area. Summary of the Invention

[0005] The present disclosure generally relates to a modular stent device comprising a body configured to deploy in the ascending aorta, a bypass valve configured to deploy in the aorta, and a bifurcated contralateral branch. The bifurcated contralateral branch includes a single proximal branch that bifurcates (diversifies) into a first distal branch and a second distal branch.

[0006] By shaping the contralateral branch of a bifurcation into a single proximal branch that branches into a distal branch, guiding the guide wire proximally into the relatively larger opening of the contralateral branch is simpler than guiding the guide wire into two smaller branches extending distally from the main body. Therefore, cannulation of the contralateral branch is relatively simple, thus simplifying the procedure. Furthermore, the parallel design mimics anatomical vascular bifurcation to limit flow interruption.

[0007] In one aspect, this disclosure provides an assembly including a first modular stent device having a body configured to deploy in the ascending aorta, a bypass valve configured to deploy in the aorta, and a bifurcated contralateral branch. The bifurcated contralateral branch includes a proximal branch extending from the body, a first distal branch extending from the proximal branch, and a second distal branch extending from the proximal branch. The first distal branch connects to the second distal branch at a diaphragm.

[0008] In another aspect, this disclosure provides an assembly including a first modular stent device having a body configured to deploy in the ascending aorta, a bypass valve configured to deploy in the aorta, and a bifurcated contralateral branch. The bifurcated contralateral branch includes a first distal branch configured to perfuse the brachiocephalic artery and a second distal branch configured to perfuse the left common carotid artery. The first distal branch connects to the second distal branch at a diaphragm.

[0009] In another aspect, this disclosure provides a method comprising deploying a first modular stent device, the first modular stent device including a body for deploying the first modular stent device in the ascending aorta, a bypass gate for deploying the first modular stent device in the aorta, and a contralateral branch of a bifurcation for deploying the first modular stent device proximally in the brachiocephalic artery. The contralateral branch of the bifurcation includes a first distal branch that connects to a second distal branch at a septum.

[0010] Details of one or more aspects of this disclosure are set forth in the accompanying drawings and the following description. Other features, objects, and advantages of the technology described in this disclosure will become apparent from the description and drawings and from the claims. Attached Figure Description

[0011] Figure 1 This is a side plan view of a modular support assembly according to one embodiment.

[0012] Figure 2 According to one embodiment Figure 1 A perspective view of the modular support assembly.

[0013] Figure 3 To include during unfolding according to one embodiment Figure 1 and 2 A cross-sectional view of the vascular assembly of a modular stent device.

[0014] Figure 4 According to one embodiment Figure 3 A cross-sectional view of the vascular assembly during the later stages of the first bridging stent graft deployment.

[0015] Figure 5 According to one embodiment Figure 4 A cross-sectional view of the vascular assembly during the later stage of the second bridging stent graft deployment.

[0016] Figure 6 According to one embodiment, in the later stage of deploying the tube graft into the modular scaffold device... Figure 5 A cross-sectional view of the vascular assembly.

[0017] Figure 7This is a side plan view of a second modular support device according to one embodiment.

[0018] Figure 8 According to one embodiment Figure 7 A perspective view of the second modular support assembly.

[0019] Figure 9 According to one embodiment Figure 5 The vascular assembly in Figure 7 and 8 A cross-sectional view of the second modular support device unfolded into the later stage of the modular support device.

[0020] Figure 10 According to one embodiment Figure 9 A cross-sectional view of the vascular assembly during the later stages of deployment of the bridging stent graft. Detailed Implementation

[0021] Figure 1 This is a side plan view of a modular support device 100 according to one embodiment. Figure 2 According to one embodiment Figure 1 A perspective view of the modular support assembly 100. Refer to it now. Figure 1 and 2 The modular stent device 100, sometimes referred to as a prosthesis or aortic arch prosthesis, includes a body 102, a bypass gate 104, and a bifurcation contralateral branch 106.

[0022] According to this embodiment, the body 102 includes a proximal opening 108 at its proximal end 110. The distal end 112 of the body 102 is connected to the proximal end 114 of the bypass door 104 and the proximal end 116 of the bifurcated opposite branch 106. The bypass door 104 includes a distal opening 118 at its distal end 120.

[0023] As used herein, the proximal end of a prosthesis (such as the modular stent device 100) is the end closest to the heart via the blood flow path, while the distal end is the end furthest from the heart during deployment. In contrast, and noteworthy, the distal end of a catheter is typically identified as the end furthest from the operator / handle, while the proximal end is the end closest to the operator / handle.

[0024] For clarity of discussion, as used herein, the distal end of the catheter is the end furthest from the operator (the end furthest from the handle), while the distal end of the modular support device 100 is the end closest to the operator (the end closest to the handle). That is, the distal end of the catheter and the proximal end of the modular support device 100 are the ends furthest from the handle, while the proximal end of the catheter and the distal end of the modular support device 100 are the ends closest to the handle. However, those skilled in the art will understand that, depending on the inlet location, the description of the modular support device 100 and the delivery system may be consistent or opposite in actual use.

[0025] The bifurcated contralateral branch 106 branches from a single proximal opening at proximal end 116 to two distal openings 122, 124. More specifically, the bifurcated contralateral branch 106 includes a single proximal branch 126 that bifurcates (separates) at a transition region 132 of the bifurcated contralateral branch 106 into a first distal branch 128 and a second distal branch 130. More specifically, the proximal branch 126 extends distally from proximal end 116 to transition region 132 and includes a single lumen. The first distal branch 128 extends distally from transition region 132 to distal opening 122 at distal end 134 of the first distal branch 128 and includes a single lumen. The second distal branch 130 extends distally from transition region 132 to distal opening 124 at distal end 136 of the second distal branch 130 and includes a single lumen.

[0026] By forming a bifurcated contralateral branch 106 to include a single proximal branch 126 that branches into distal branches 128, 130, guiding the guide wire at the proximal end 116 into the relatively larger opening of the bifurcated contralateral branch 106 is simpler than guiding the guide wire into the two smaller branches extending distally from the body 102. Therefore, cannulation of the bifurcated contralateral branch 106 is relatively simple, thus simplifying the process described below.

[0027] The main body 102 includes a graft material 138 and one or more circumferential supports 140 connected to the graft material 138. The graft material 138 can be any suitable graft material, such as, but not limited to, woven polyester, Materials, expanded polytetrafluoroethylene, polyurethane, silicone, electrospun materials or other suitable materials.

[0028] The circumferential scaffold 140 can be attached to the transplant material 138 using sutures or other methods. Figure 1 and 2 In the illustrated embodiment, the circumferential scaffold 140 is attached to the outer surface of the transplant material 138. However, the circumferential scaffold 140 may also be attached to the inner surface of the transplant material 138.

[0029] Although a specific number of circumferential supports 140 are shown, those skilled in the art will understand from this disclosure that the body 102 may include more or fewer supports 140, for example, depending on the desired length of the body 102 and / or its intended application.

[0030] The circumferential stent 140 can be made of any stent material or configuration. As shown, the circumferential stent 140, such as a self-expanding member, is preferably made of a shape memory material, such as a nickel-titanium alloy (NiTiNO3), and is formed in a zigzag configuration. The configuration of the circumferential stent 140 is merely exemplary, and the circumferential stent 140 can have any suitable configuration, including but not limited to continuous or discontinuous helical configurations. In another embodiment, the circumferential stent 140 is a balloon dilatation stent.

[0031] The circumferential support 140A disposed at the proximal end 110 is referred to herein as the proximal end support 140A. Figure 1 and 2 In one embodiment, the proximal scaffold 140A extends only to the edge of the graft material 138 in the illustrated closed mesh configuration. However, in another embodiment, the proximal scaffold 140A extends proximally beyond the edge of the graft material 138 in an open mesh or uncovered configuration.

[0032] Furthermore, the body 102 includes a longitudinal axis LAI. An inner cavity 142 is defined by the graft material 138 and is generally defined by the body 102. The inner cavity 142 is substantially parallel to the longitudinal axis LAI and extends between the proximal opening 108 and the distal end 112 of the body 102. In this embodiment, the graft material 138 is cylindrical with a substantially uniform diameter. However, in other embodiments, the diameter of the graft material 138 varies.

[0033] The bypass gate 104 includes a graft material 144 and one or more circumferential supports 146 connected to the graft material 144. The graft material 144 can be any suitable graft material, such as, but not limited to, woven polyester, Materials, expanded polytetrafluoroethylene, polyurethane, silicone, electrospun materials or other suitable materials.

[0034] The circumferential scaffold 146 can be attached to the transplant material 144 using sutures or other methods. Figure 1 and 2 In the illustrated embodiment, the circumferential scaffold 146 is attached to the outer surface of the transplant material 144. However, the circumferential scaffold 146 may also be attached to the inner surface of the transplant material 144.

[0035] Although a specific number of circumferential supports 146 are shown, those skilled in the art will understand from this disclosure that the bypass door 104 may include more or fewer supports 146, for example, depending on the desired length of the bypass door 104 and / or its intended application.

[0036] The circumferential stent 146 can be made of any stent material or configuration. As shown, the circumferential stent 146, such as a self-expanding member, is preferably made of a shape memory material, such as a nickel-titanium alloy (NiTiNO3), and is formed in a zigzag configuration. The configuration of the circumferential stent 146 is merely exemplary, and the circumferential stent 146 can have any suitable configuration, including but not limited to continuous or discontinuous helical configurations. In another embodiment, the circumferential stent 146 is a balloon dilatation stent.

[0037] Furthermore, the bypass gate 104 includes a longitudinal axis LA2. An inner lumen 148 is defined by the graft material 144 and is generally defined by the bypass gate 104. The inner lumen 148 is generally parallel to the longitudinal axis LA2 and extends between the proximal end 114 and the distal opening 118 of the bypass gate 104. In this embodiment, the graft material 144 is cylindrical with a substantially uniform diameter. However, in other embodiments, the diameter of the graft material 144 varies.

[0038] As described above, the bifurcated contralateral branch 106 includes a proximal branch 126, a first distal branch 128, and a second distal branch 130. Branches 126, 128, and 130 include graft materials 150, 152, and 154, and one or more circumferential scaffolds 156, 158, and 160 respectively connected to the graft materials 150, 152, and 154. The graft materials 150, 152, and 154 can be any suitable graft material, such as, but not limited to, woven polyester. Materials, expanded polytetrafluoroethylene, polyurethane, silicone, electrospun materials or other suitable materials.

[0039] The circumferential scaffolds 156, 158, and 160 can be connected to the transplant materials 150, 152, and 154 respectively using sutures or other methods. Figure 1 and 2 In the illustrated embodiment, the circumferential scaffolds 156, 158, and 160 are respectively connected to the outer surfaces of the transplant materials 150, 152, and 154. However, the circumferential scaffolds 156, 158, and 160 may also be connected to the inner surfaces of the transplant materials 150, 152, and 154.

[0040] Although a specific number of circumferential supports 156, 158, 160 are shown, those skilled in the art will understand from this disclosure that branches 126, 128, 130 may include more or fewer supports 156, 158, 160, for example, depending on the desired length of supports 126, 128, 130 and / or their intended application.

[0041] The circumferential stents 156, 158, and 160 can be made of any stent material or configuration. As shown, the circumferential stents 156, 158, and 160, such as self-expanding members, are preferably made of shape memory materials, such as nickel-titanium alloys (NiTiNO3), and are formed in a Z-shaped configuration. The configuration of the circumferential stents 156, 158, and 160 is merely exemplary, and the circumferential stents 156, 158, and 160 can have any suitable configuration, including but not limited to continuous or discontinuous spiral configurations. In another embodiment, the circumferential stents 156, 158, and 160 are balloon dilatation stents.

[0042] Furthermore, the proximal branch 126 includes a longitudinal axis LA3. The lumen 162 is defined by the graft material 150 and is generally defined by the proximal branch 126. The lumen 162 is generally parallel to the longitudinal axis LA3 and extends between the proximal end 116 of the bifurcated contralateral branch 106 and the transition region 132. In this embodiment, the graft material 150 is cylindrical with a substantially uniform diameter. However, in other embodiments, the diameter of the graft material 150 varies.

[0043] Furthermore, the first distal branch 128 includes a longitudinal axis LA4. A lumen 164 is defined by the graft material 152 and is generally defined by the first distal branch 128. The lumen 164 is generally parallel to the longitudinal axis LA4 and extends between the transition region 132 of the first distal branch 128 and the distal opening 122. In this embodiment, the graft material 152 is cylindrical with a substantially uniform diameter. However, in other embodiments, the diameter of the graft material 152 varies.

[0044] The second distal branch 130 includes a longitudinal axis LA5. A lumen 166 is defined by the graft material 154 and is generally defined by the second distal branch 130. The lumen 166 is generally parallel to the longitudinal axis LA5 and extends between the transition region 132 of the second distal branch 130 and the distal opening 124. In this embodiment, the graft material 154 is cylindrical with a substantially uniform diameter. However, in other embodiments, the diameter of the graft material 154 varies.

[0045] In one embodiment, the first distal branch 128 is connected to the second distal branch 130 at the septum 168. For example, the graft materials 150, 152, and 154 are monolithic graft materials that are sutured or otherwise joined together at the septum 168 to define the branches 128 and 130. However, in another embodiment, the branches 128 and 130 are not attached to each other, such that the branch 128 can be unfolded or moved apart from the branch 130.

[0046] Typically, the main body 102 branches at its distal end 112 into a bypass gate 104 and a branch on the opposite side of the branch 106. More specifically, the interior of the main body 102 branches into the interior of the bypass gate 104 (148) and the interior of the proximal branch 126 (162). The interior of the proximal branch 126 (162) branches into the interior of the first distal branch (164) and the interior of the second distal branch 130 (166).

[0047] In one embodiment, the transplant materials 138, 144, 150, 152, and 154 may be the same transplant material, for example, a single piece of transplant material that has been cut and sutured together. However, in other embodiments, one or more transplant materials 138, 144, 150, 152, and 154 may be different from the other transplant materials 138, 144, 150, 152, and 154, for example, different transplant materials may be cut and sutured together.

[0048] In such Figure 1 and 2 In the relaxed configuration (stress-free) of the modular support device 100 shown, the longitudinal axes LAI, LA2, LA3, LA4, and LA5 are parallel to each other, such that the bypass door 104 and the opposite side branch 106 of the bifurcation extend from the main body 102 to the distal end, and the distal branches 128 and 130 extend from the proximal branch 126 to the distal end.

[0049] Furthermore, the longitudinal axis LA4 of the first distal branch 128 is located radially outside the longitudinal axis LA5 of the second distal branch 130. In other words, the second distal branch 130 is located radially inside the first distal branch 128. The second distal branch 130 is located between the bypass gate 104 and the first distal branch 128. However, in other embodiments, depending on the specific application, other orientations of the distal branches 128, 130 relative to the bypass gate 104 are used.

[0050] The main body 102 has a first diameter D1, the bypass gate 104 has a second diameter D2, and the bifurcated opposite branch 106 (e.g., proximal branch 126) has a third diameter D3. According to this embodiment, the first diameter D1 is larger than the second diameter D2. Furthermore, the second diameter D2 is larger than the third diameter D3. According to this embodiment, the first diameter D1 is greater than the sum of the second diameter D2 and the third diameter D3 (D1>D2+D3), such that the bypass gate 104 and the bifurcated opposite branch 106 are located within an imaginary cylinder defined by the graft material 138 of the main body 102 extending in the distal direction.

[0051] Furthermore, the first distal branch 128 has a fourth diameter D4, and the second distal branch 130 has a fifth diameter D5. According to this embodiment, the third diameter D3 of the proximal branch 126 is greater than either the fourth diameter D4 or the fifth diameter D5. The parallel design simulates anatomical vascular bifurcation to limit flow interruptions.

[0052] In one embodiment, at the distal end 112 and the proximal ends 114, 116 (sometimes referred to as the main transition region), the first diameter D1 is greater than the sum of the second diameter D2 and the third diameter D3 (D1>D2+D3). However, according to one embodiment, the main body 102, the bypass door 104, and / or the opposite side branches 106 of the bifurcation open or gradually taper away from the main transition region, so D1>D2+D3 at the main transition region, but not necessarily in the region away from the main transition region.

[0053] In other words, the main transition region from the main body 102 to the bifurcation contralateral branch 106 and bypass gate 104 does not exceed the first diameter D1 of the main body 102. This ensures that the bifurcation contralateral branch 106 and bypass gate 104 do not compress each other or negatively affect flow in any way. By preventing the bifurcation contralateral branch 106 and bypass gate 104 from extending outwards wider than the main body 102, a good seal of the stent 140 of the main body 102 to the aorta is ensured, and type I endoleak is minimized or avoided.

[0054] According to one embodiment, the main transition region between the main body 102 and the bifurcated opposite branch 106 and bypass gate 104 is entirely supported by one or more support brackets (e.g., brackets 140, 146, 156) to prevent kinking in the angled anatomy. Without the support brackets, the modular bracket assembly 100 may be easily bent into a Type III bow or a Gothic bow.

[0055] The main body 102 has a first length L1 in a direction parallel to the longitudinal axis LA1, the bypass door 104 has a second length L2 in a direction parallel to the longitudinal axis LA2, and the bifurcated opposite branches 106 have a third length L3 in a direction parallel to the longitudinal axes LA3, LA4, and LA5. According to this embodiment, the third length L3 is less than the second length L2, such that the distal openings 122 and 124 of the bifurcated opposite branches 106 are close to the distal opening 118 of the bypass door 104. Typically, the bifurcated opposite branches 106 are shorter than the bypass door 104. According to this embodiment, the distal openings 122 and 124 of the bifurcated opposite branches 106 are aligned and coplanar.

[0056] The contralateral branch 106 of the bifurcation is configured to apply a higher radial force than that applied to the bypass portal 104. As used herein, “radial force” includes the radial force applied during dilation / undilation, as well as the chronic radial force applied continuously after implantation, such that the surrounding natural anatomical structures (e.g., the aorta) have a predetermined compliance or resistance as they expand and contract during cardiac circulation. The radial force of the bypass portal 104 is configured to be lower than that of the contralateral branch 106 of the bifurcation to prevent collapse of the contralateral branch 106 of the bifurcation when the bypass portal 104 is deployed against and adjacent to it, thereby maintaining perfusion of the brachiocephalic artery and the left common carotid artery, as discussed further below.

[0057] To configure the bypass door 104 and the bifurcated opposite branches 106 with different relative radial forces, the circumferential supports 156, 158, and 160 of the bifurcated opposite branches 106 are configured with material segments that are relatively thicker and / or shorter than the circumferential support 146 of the bypass door 104. The shorter and / or thicker circumferential supports 156, 158, and 160 have less flexibility but greater radial force to ensure that the circumferential support 146 of the bypass door 104 does not cause the cavities 162, 164, and 166 of the bifurcated opposite branches 106 to collapse. In other embodiments, other variations or modifications of the circumferential supports 146, 156, 158, and 160 may be used to achieve the relative radial force.

[0058] Figure 3 To include during deployment according to one embodiment Figure 1 and 2 A cross-sectional view of the vascular assembly 300 of the modular stent device 100. (See also:) Figure 1 , 2The thoracic aorta 302 has numerous arterial branches. The aortic arch AA of the aorta 302 has three main branches extending from it, all of which typically originate from the convex superior surface of the aortic arch AA. The brachiocephalic artery (BCA) originates anterior to the trachea. The BCA divides into two branches, the right subclavian artery (RSA) (supplying the right arm) and the right common carotid artery (RCC) (supplying the right side of the head and neck). The left common carotid artery (LCC) originates to the left of the aortic arch AA at the origin of the BCA. The LCC supplies blood to the left side of the head and neck. The third branch originating from the aortic arch AA, the left subclavian artery (LSA), originates posterior to and to the left of the LCC's origin and supplies blood to the left arm.

[0059] However, a large portion of the population has only two major branch vessels originating from the aortic arch AA, while others have four major branch vessels originating from the aortic arch AA. Therefore, although specific anatomical geometries of the aortic arch AA have been shown and discussed, those skilled in the art will understand, based on this disclosure, that the geometry of the aortic arch AA is subject to anatomical variations and that the various structures disclosed herein will be modified accordingly.

[0060] Aneurysms, dissections, penetrating ulcers, intramural hematomas, and / or transections, commonly referred to as the lesion area of ​​aorta 302, can occur in the aortic arch (AA) and peripheral arteries (BCA, LCC, LSA). For example, thoracic aortic aneurysms include aneurysms present in the ascending thoracic aorta, the aortic arch (AA), and one or more branch arteries arising from it (BCA, LCC, LSA). Thoracic aortic aneurysms also include aneurysms present in the descending thoracic aorta and its branch arteries. Therefore, as... Figure 3 The aorta 302 shown may have a lesion area similar to any of the regions discussed above, as discussed below, which will be bypassed and excluded using the modular stent device 100.

[0061] To deploy the modular stent device 100, a guide suture is introduced via the femoral access. In one particular embodiment, the guide suture is inserted into the femoral artery, ascends through the abdominal aorta, and enters the thoracic aorta.

[0062] The delivery system, including the modular stent device 100, is introduced via the femoral access and advanced into the ascending aorta 302 via a guide wire. The delivery system is positioned as desired, such that the modular stent device 100 is located in the ascending aorta near the aortic valve AV.

[0063] The conveyor sheath of the conveyor system is withdrawn to expose the main body 102, the opposite branch 106 of the fork, and the bypass door 104. This unfolds the main body 102, the opposite branch 106 of the fork, and the bypass door 104.

[0064] The contralateral branch 106 of the bifurcation is opened to ensure perfusion to distal regions, including, for example, the brachiocephalic artery (BCA) and the left common carotid artery (LCC). According to this embodiment, the distal openings 122, 124 of the contralateral branch 106 of the bifurcation are located close to the brachiocephalic artery (BCA) and the left common carotid artery (LCC), thereby allowing for easy cannulation as described below.

[0065] According to this embodiment, the distal opening 118 of the bypass gate 104 is located close to the left subclavian artery (LSA) to ensure its perfusion.

[0066] Figure 4 According to one embodiment Figure 3 A cross-sectional view of the vascular assembly 300 during a later stage of deployment of the first bridging stent graft 402 (sometimes referred to as a bridging stent). Reference Figure 4 The bridging stent graft 402 is deployed within the second distal branch 130 and the left common carotid artery LCC. More specifically, the bridging stent graft 402 self-inflates (or balloon inflates) to anchor within the second distal branch 130 and the left common carotid artery LCC.

[0067] The bridging stent graft 402 includes graft material 404 and one or more circumferential stents 406. When the bridging stent graft 402 deploys, blood flow into the contralateral branch 106 of the bifurcation and the second distal branch 130 is bridged and enters the left common carotid artery (LCC) through the bridging stent graft 402.

[0068] Figure 5 According to one embodiment Figure 4 A cross-sectional view of the vascular assembly 300 during a later stage of deployment of the second bridging stent graft 502 (sometimes referred to as a bridging stent). Reference Figure 5 The bridging stent graft 502 is deployed within the first distal branch 128 and the brachiocephalic artery BCA. More specifically, the bridging stent graft 502 self-inflates (or balloon inflates) to anchor within the first distal branch 128 and the brachiocephalic artery BCA.

[0069] The bridging stent graft 502 includes graft material 504 and one or more circumferential stents 506. When the bridging stent graft 502 deploys, blood flow into the contralateral branch 106 and the first distal branch 128 of the bifurcation is bridged and enters the brachiocephalic artery (BCA) through the bridging stent graft 502.

[0070] In various embodiments, bridging stent grafts 402, 502 are deployed from either the femoral or superior aortic access route. When deployed from the femoral access route, a guide wire is introduced through the femoral access route. In one particular embodiment, the guide wire is inserted into the femoral artery and passes upward through the abdominal aorta, entering the distal opening 118 of the bypass portal 104. The guide wire is then manipulated into the proximal branch 126 of the bifurcation contralateral branch 106. Guide wire deployment is simplified because the diameter D3 of the bifurcation contralateral branch 106 is relatively larger than the diameters D4 and D5 of the distal branches 128, 130, respectively. During the deployment of bridging stent graft 402, the guide wire exits from the distal opening 124 of the second distal branch 130 and enters the left common carotid artery (LCC). Alternatively, during the deployment of bridging stent graft 502, the guide wire exits from the distal opening 122 of the first distal branch 128 and enters the brachiocephalic artery (BCA).

[0071] A delivery system, including bridging scaffold graft 402 or 502, is introduced via the femoral access and advanced via a guide suture. The delivery system is positioned as desired. The delivery sheath of the delivery system is withdrawn to expose bridging scaffold graft 402 or 502. This unfolds bridging scaffold graft 402 or 502. The process is then repeated to unfold another bridging scaffold graft 402 or 502.

[0072] When deploying via the superior aortic access, a guide wire is introduced through the superior aortic access, for example, through the left common carotid artery (LCC) or brachiocephalic artery (BCA). The guide wire is then manipulated from the left common carotid artery (LCC) into the distal opening 124 of the second distal branch 130 to deploy the bridging stent graft 402. Alternatively, the guide wire is manipulated from the brachiocephalic artery (BCA) into the distal opening 122 of the first distal branch 128 to deploy the bridging stent graft 502.

[0073] A delivery system, including bridging stent graft 402 or 502, is introduced via the superior aortic access and advanced through a guideline. The delivery system is positioned as desired. The delivery sheath of the delivery system is withdrawn to expose bridging stent graft 402 or 502. This unfolds bridging stent graft 402 or 502. The process is then repeated to unfold another of bridging stent grafts 402 or 502.

[0074] Figure 6 According to one embodiment Figure 5The vascular assembly 300 is shown in cross-section during a later stage of deploying the cannula graft 602 into the modular stent device 100. To deploy the cannula graft 602, a delivery system including the cannula graft 602 is inserted through a femoral access into the distal opening 118 of the bypass gate 104. Once positioned, the delivery sheath of the delivery system is withdrawn to expose the cannula graft 602. When exposed, the cannula graft 602 self-inflates (or is balloon-inflated) into and attaches to the bypass gate 104 and the aorta 302.

[0075] The tube graft 602 includes graft material 604 and one or more circumferential scaffolds 606. The graft material 604 is similar to or identical to any of the graft materials discussed. Furthermore, the circumferential scaffolds 606 are similar to or identical to any of the aforementioned circumferential scaffolds.

[0076] When the catheter graft 602 has fully deployed, blood flows through the bypass gate 104 and the catheter graft 602, thereby perfusing the distal region. Simultaneously, the bypass gate 104 and the catheter graft 602 exclude any overlapping lesions in the aorta 302.

[0077] According to this embodiment, the graft 602 overlaps, excludes, and thus occludes the left subclavian artery (LSA). According to this embodiment, a bypass 608 provides perfusion to the left subclavian artery (LSA). Illustratively, the bypass 608 provides perfusion to the left subclavian artery (LSA) from the left common carotid artery (LCC).

[0078] The bypass 608 is surgically inserted during the same process as the deployment of the modular stent device 100 and the tube graft 602. However, in another embodiment, the bypass 608 is surgically inserted before the deployment of the modular stent device 100 and the tube graft 602, for example, to simplify the procedure.

[0079] In one embodiment, the cannula graft 602 is unnecessary and not deployed. For example, the modular stent device 100 adequately excludes the diseased area of ​​the aorta 302. Therefore, the cannula graft 602 is unnecessary and not deployed. With the cannula graft 602 not deployed, perfusion to the left subclavian artery LSA is maintained, thus bypass 608 is not required.

[0080] In addition, such as Figure 6 As shown, optionally, the proximal cuff 612 is coupled to and extends proximally from the body 102 of the modular stent assembly 100. For example, the proximal cuff 612 is deployed when the proximal end 110 of the body 102 deploys distally from the aortic valve AV to extend between the desired deployment position and the proximal end 110 of the body 102. The proximal cuff 612 is optional and, in one embodiment, is not deployed or used.

[0081] The proximal cuff 612 includes a graft material 614 and one or more circumferential scaffolds 616. The graft material 614 is similar to or the same as any of the graft materials described above. Furthermore, the circumferential scaffolds 616 are similar to or the same as any of the circumferential scaffolds described above.

[0082] Figure 7 This is a side plan view of a second modular support device 700 according to one embodiment. Figure 8 According to one embodiment Figure 7 A perspective view of the second modular support unit 700. Now refer to it together. Figure 1 , 2 7 and 8, the second modular stent device 700 includes a body 102A, a bypass gate 104A, and an arterial branch 706. The second modular stent device 700 is similar to the modular stent device 100 as described above; only the significant differences will be discussed below. More specifically, the body 102A and bypass gate 104A of the second modular stent device 700 are similar to the body 102 and bypass gate 104 of the modular stent device 100; therefore, for simplicity, their description will not be repeated.

[0083] Let's refer to it together now. Figure 7 and 8 The second modular stent device 700 shown has a distal end 112 of the main body 102A connected to the proximal end 716 of an arterial branch 706. The arterial branch 706 includes a distal leg opening 722 at its distal end 724.

[0084] Artery branch 706 includes graft material 738 and one or more circumferential stents 740 connected to graft material 738. Graft material 738 can be any suitable graft material, such as those discussed above. Furthermore, circumferential stent 140 can be any stent material or configuration as described above.

[0085] The circumferential scaffold 740 can be attached to the transplant material 738 using sutures or other methods. Figure 7 and 8 In the illustrated embodiment, the circumferential scaffold 740 is attached to the outer surface of the transplant material 738. However, the circumferential scaffold 740 may also be attached to the inner surface of the transplant material 738.

[0086] Although a specific number of circumferential stents 740 are shown, those skilled in the artery will understand from this disclosure that the arterial branch 706 may include more or fewer stents 740, for example, depending on the desired length of the arterial branch 706 and / or its intended application.

[0087] Furthermore, arterial branch 706 includes a longitudinal axis LA3A. Lumen 762 is defined by graft material 738 and is generally defined by arterial branch 706. Lumen 762 is substantially parallel to the longitudinal axis LA3A and extends between the proximal end 716 and the distal opening 722 of arterial branch 706. In this embodiment, graft material 738 is cylindrical with a substantially uniform diameter. However, in other embodiments, the diameter of graft material 738 varies.

[0088] Typically, the main body 102A branches at its distal end 112 into a bypass portal 104A and an arterial branch 706. More specifically, the lumen 142 of the main body 102A branches into the lumen 148 of the bypass portal 104A and the lumen 762 of the arterial branch 706.

[0089] The main body 102A has a first length L71 in a direction parallel to its longitudinal axis LAI, the bypass gate 104A has a second length L72 in a direction parallel to its longitudinal axis LA2, and the arterial branch 706 has a third length L73 in a direction parallel to its longitudinal axis LA3A. According to this embodiment, the third length L73 is shorter than the second length L72, such that the distal opening 722 of the arterial branch 706 is close to the distal opening 118 of the bypass gate 104A. Typically, the arterial branch 706 is shorter than the bypass gate 104A.

[0090] Arterial branch 706 is configured to apply a higher radial force than that of bypass gate 104A to prevent collapse of arterial branch 706 caused by bypass gate 104A. Further description of a device similar to the second modular stent device 700 is set forth in U.S. Patent Application Serial No. 16 / 367,889, entitled "Modular Stent Device and Method for Multivessels" filed March 28, 2019, by Perkins et al., and in U.S. Patent Application Serial No. 16 / 367,922, entitled "Femoral Aortic Access Modular Stent Assembly and Method" filed March 28, 2019, by Perkins et al., the entire contents of which are incorporated herein by reference.

[0091] Figure 9 According to one embodiment, in the Figure 7 and 8 The second modular support device 700 is deployed to the later stage of the modular support device 100. Figure 5A cross-sectional view of the vascular assembly 300. According to this embodiment, the second modular stent device 700 is deployed within the bypass gate 104 of the modular stent device 100 via a femoral access, in a manner similar to that described above with respect to the modular stent device 100.

[0092] More specifically, the body 102A of the second modular stent device 700 is located within the bypass gate 104 of the modular stent device 100 (sometimes referred to as the first modular stent device 100). The bypass gate 104A of the second modular stent device 700 is located within the aorta 302 and is positioned distally away from the first modular stent device 100. According to this embodiment, the distal opening 722 of the arterial branch 706 of the second modular stent device 700 is close to the left subclavian artery (LSA), thereby allowing for easy cannulation, as described below.

[0093] According to this embodiment, blood flows through the main gate 102A into the second modular stent device 700 and exits through the bypass gate 104A and the arterial branch 706. Therefore, blood flows through the arterial branch 706, ensuring perfusion of the left subclavian artery (LSA).

[0094] Figure 10 This is according to one embodiment, during the later stage of deployment of the bridging scaffold graft 1002 (sometimes referred to as a bridging scaffold). Figure 9 A cross-sectional view of the vascular assembly 300. (See also...) Figure 9 and 10 The bridging stent graft 1002 is deployed within the arterial branch 706 and the left subclavian artery LSA. More specifically, the bridging stent graft 1002 self-expands (or balloon-expands) to anchor within the arterial branch 706 and the left subclavian artery LSA. The bridging stent graft 1002 is deployed via the superior aortic pathway through the left subclavian artery LSA in a manner similar to the deployment described above for bridging stent grafts 402 and 502, or via the femoral pathway.

[0095] The bridging stent graft 1002 includes graft material 1004 and one or more circumferential stents 1006. When the bridging stent graft 1002 deploys, blood flow into the arterial branch 706 is bridged and passes through the bridging stent graft 1002 into the left subclavian artery (LSA). In this way, any overlapping lesion areas of the aorta 302 are excluded.

[0096] Although the above description and explanation of remote components, such as Figure 6 tube graft 602 and Figure 10The second modular stent assembly 700 is connected to the modular stent assembly 100 in this embodiment, but in other embodiments, other distal components are connected to the modular stent assembly 100. Examples of other distal components are given in U.S. Patent Application Serial No. 16 / 367,906, entitled "SUPRA AORTIC ACCESS MODULAR STENTASSEMBLY AND METHOD," filed March 28, 2019, by Perkins et al., the entire contents of which are incorporated herein by reference. See also U.S. Patent Application Serial Nos. 16 / 367,889 and 16 / 367,922 by Perkins et al. Other distal extensions may be added to any of the embodiments described herein using thoracic devices.

[0097] It should be understood that the various aspects disclosed herein can be combined with combinations different from those specifically presented in the specification and drawings. It should also be understood that, depending on the example, the actions or events of any process or method described herein can be performed in a different order, and can be added, combined, or excluded entirely (e.g., all described actions and events may not be necessary for performing the technique). Furthermore, although certain aspects of this disclosure are described for clarity as being performed by a single module or unit, it should be understood that the techniques of this disclosure can be performed by combinations of units or modules associated with, for example, a medical device.

Claims

1. An assembly comprising: The first modular support device comprises: The main body is configured to unfold within the ascending aorta; Bypass gate, the bypass gate being configured to deploy within the aorta; and The opposite branch of the bifurcation includes: Proximal branches extending from the main body; A first distal branch extending from the proximal branch; as well as A second distal branch extends from the proximal branch, wherein the first distal branch connects to the second distal branch at the diaphragm. The transplant materials for the main body, the bypass gate, and the opposite branches of the bifurcation are single-piece transplant materials that are cut and sutured. The bypass door has a diameter greater than the diameter of the opposite branch of the fork, the length of the opposite branch of the fork is shorter than the length of the bypass door, and the radial force of the bypass door is configured to be lower than the radial force of the opposite branch of the fork.

2. The assembly according to claim 1, wherein, The opposite branches of the bifurcation branch from a single proximal opening to two distal openings.

3. The assembly according to claim 1, wherein, The proximal branch branches into the first distal branch and the second distal branch.

4. The assembly according to claim 3, wherein, The opposite branch of the bifurcation also includes a transition region in which the proximal branch bifurcates into the first distal branch and the second distal branch.

5. The assembly according to claim 4, wherein, The proximal branch extends from the proximal end of the opposite branch of the bifurcation to the distal end of the transition region and contains a single lumen.

6. The assembly according to claim 5, wherein: The first distal branch extends distally from the transition region to the distal end of the first distal branch and includes a single lumen.

7. The assembly according to claim 6, wherein: The second distal branch extends distally from the transition region to the distal end of the second distal branch and includes a single lumen.

8. The assembly according to claim 1, wherein: The proximal branch includes a longitudinal axis; The first distal branch includes a longitudinal axis; and The second distal branch includes a longitudinal axis, and when the first modular support device is in a relaxed configuration, the longitudinal axes of the proximal branch, the first distal branch, and the second distal branch are parallel to each other.

9. The assembly according to claim 1, wherein, The second distal branch is radially inside the first distal branch.

10. The assembly according to claim 1, wherein, The second distal branch is located between the bypass gate and the first distal branch.

11. An assembly comprising: The first modular support device comprises: The main body is configured to unfold within the ascending aorta; Bypass gate, the bypass gate being configured to deploy within the aorta; and The opposite branch of the bifurcation includes: Configured to perfuse the first distal branch of the brachiocephalic artery; and It is configured to perfuse the second distal branch of the left common carotid artery, wherein, The first distal branch connects to the second distal branch at the diaphragm, and The assembly further includes a proximal cuff configured to be coupled to the body. The bypass door has a diameter greater than the diameter of the opposite branch of the fork, the length of the opposite branch of the fork is shorter than the length of the bypass door, and the radial force of the bypass door is configured to be lower than the radial force of the opposite branch of the fork.

12. The assembly of claim 11, further comprising: A first bridging stent graft, configured to deploy in the second distal branch and in the left common carotid artery; and A second bridging stent graft is configured to deploy in the first distal branch and the brachiocephalic artery.

13. The assembly of claim 11, further comprising a tube graft configured to be connected to the bypass gate.

14. The assembly of claim 11, further comprising: The second modular support device includes: The main body is configured to unfold within the bypass door of the first modular support assembly; Bypass door; and Arterial leg.

15. The assembly of claim 14, further comprising a bridging stent graft configured to connect to the arterial leg and the left subclavian artery of the second modular stent assembly.

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