Modular multi-branch stent assembly and method

Abstract

The technology disclosed herein generally relates to an assembly comprising a unibranch stent device and a modular stent device configured to be coupled to the unibranch stent device. The unibranch stent device comprises a body and a branch coupler extending radially from the body. The modular stent device comprises a body configured to be coupled within the body of the unibranch stent device; a bypass gate extending distally from a distal end of the body of the modular stent device; and an arterial leg extending distally from the distal end of the body of the modular stent device.

Description

Technical Field

[0001] The present technology generally relates to an intravascular device and method. More specifically, the present application relates to a device for treating intravascular diseases. Background Art

[0002] Aneurysms, dissections, penetrating ulcers, intramural hematomas, and / or transections can occur in blood vessels, most typically in the aorta and peripheral arteries. The diseased area of ​​the aorta can extend to areas with bifurcations or aortic segments, where smaller "branch" arteries extend from the bifurcation.

[0003] The diseased area of ​​the aorta can be bypassed using a stent graft placed within a blood vessel spanning the diseased portion of the aorta to seal the diseased portion from further exposure to blood flowing through the aorta.

[0004] Using a stent graft to internally bypass a diseased portion of the aorta presents its own challenges. Specifically, care must be taken so that critical branch arteries are not covered or blocked by the stent graft, while the stent graft must seal against the aortic wall and provide a flow conduit for blood to flow through the diseased portion. Summary of the Invention

[0005] The technology disclosed herein generally relates to an assembly comprising a unibranch stent device and a modular stent device configured to be coupled to the unibranch stent device. The unibranch stent device comprises a body and a branch coupler extending radially from the body. The modular stent device comprises a body configured to be coupled within the body of the unibranch stent device; a bypass gate extending distally from a distal end of the body of the modular stent device; and an arterial leg extending distally from the distal end of the body of the modular stent device.

[0006] In one aspect, the present disclosure provides a method comprising introducing a single-branch stent device via a femoral artery access port, advancing the single-branch stent device into the ascending aorta, and deploying the single-branch stent device such that the body of the single-branch stent device engages the aorta and a branch coupler perfuses the brachiocephalic artery. The method further comprises introducing a modular stent device via a supra-aortic access port through an artery distal to the brachiocephalic artery, advancing the modular stent device such that the body of the modular stent device is located within the body of the single-branch stent device, and deploying the modular stent device. The modular stent device is deployed such that the body of the modular stent device engages the body of the single-branch stent device, the bypass gate of the modular stent device engages the aorta, and the arterial branches of the modular stent device are located within the artery distal to the brachiocephalic artery.

[0007] In another aspect, the present disclosure provides a method comprising introducing a single-branch stent device via a femoral artery access port, advancing the single-branch stent device into the ascending aorta, and deploying the single-branch stent device such that the body of the single-branch stent device engages the aorta and a branch coupler perfuses the brachiocephalic artery. The method further comprises introducing a modular stent device via a femoral artery access port, advancing the modular stent device such that the body of the modular stent device is located within the body of the single-branch stent device, and deploying the modular stent device. The modular stent device is deployed such that the body of the modular stent device engages the body of the single-branch stent device, the bypass gate of the modular stent device engages the aorta, and the arterial branches of the modular stent device are configured to perfuse an artery distal to the brachiocephalic artery.

[0008] The details of one or more aspects of the disclosure are set forth in the following drawings and description. Other features, objects, and advantages of the techniques described in this disclosure will be apparent from the description and drawings, and from the claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0009] Figure 1 is a cross-sectional view of a vascular assembly including a unibranched stent device after deployment according to one embodiment.

[0010] Figure 2 For a later stage during deployment of a bridging stent graft according to one embodiment Figure 1 Cross-sectional view of the vascular components.

[0011] Figure 3 is a side plan view of a modular rack assembly according to one embodiment.

[0012] Figure 4 According to one embodiment Figure 3 A perspective view of a modular bracket assembly.

[0013] Figure 5 According to one embodiment, Figure 3 and Figure 4 The modular stent assembly is deployed at a later stage during Figure 2 Cross-sectional view of the vascular components.

[0014] Figure 6 The present invention provides a method for performing a final stage during deployment of a tube graft into a modular stent device and deployment of a proximal hoop into a unibranch stent device according to one embodiment. Figure 5 Cross-sectional view of the vascular components.

[0015] Figure 7 According to another embodiment, Figure 3and Figure 4 The modular stent assembly is deployed at a later stage during Figure 2 Cross-sectional view of the vascular components.

[0016] Figure 8 The present invention provides a method for performing a final stage during deployment of a tube graft into a modular stent device and deployment of a proximal hoop into a unibranch stent device according to one embodiment. Figure 7 Cross-sectional view of the vascular components.

[0017] Figure 9 is a side plan view of a modular rack assembly according to another embodiment.

[0018] Figure 10 According to one embodiment Figure 9 A perspective view of a modular bracket assembly.

[0019] Figure 11 According to another embodiment, Figure 9 and Figure 10 The modular stent assembly is deployed at a later stage during Figure 2 Cross-sectional view of the vascular components.

[0020] Figure 12 For a later stage during deployment of a bridging stent graft according to one embodiment Figure 11 Cross-sectional view of the vascular components.

[0021] Figure 13 The present invention provides a method for performing a final stage during deployment of a tube graft into a modular stent device and deployment of a proximal hoop into a unibranch stent device according to one embodiment. Figure 12 Cross-sectional view of the vascular components.

[0022] Figure 14 According to another embodiment, a bridging stent graft is deployed at a later stage. Figure 11 Cross-sectional view of the vascular components.

[0023] Figure 15 The present invention provides a method for performing a final stage during deployment of a tube graft into a modular stent device and deployment of a proximal hoop into a unibranch stent device according to one embodiment. Figure 14 Cross-sectional view of the vascular components.

[0024] Figure 16 According to another embodiment, similar to Figure 6 Cross-sectional view of the vascular component of the vascular component.

[0025] Figure 17 A branch coupler having misalignment with the brachiocephalic artery according to one embodiment Figure 2 Cross-sectional view of a region of the vascular component. DETAILED DESCRIPTION

[0026] Figure 1 FIG is a cross-sectional view of a vascular assembly 100 including a single-branch stent device 102 after deployment according to one embodiment. Figure 1 The thoracic aorta 104 has many arterial branches. The arch AA of the aorta 104 has three major branches extending from it, all of which generally originate from the convex superior surface of the arch AA. The brachiocephalic artery (BCA) arises in front of the trachea. The brachiocephalic artery (BCA) divides into two branches, the right subclavian artery (RSA) (which supplies blood to the right arm) and the right common carotid artery (RCC) (which supplies blood to the right side of the head and neck).

[0027] The left common carotid artery (LCC) originates from the arch AA of the aorta 104, just distal to the origin of the brachiocephalic artery (BCA). The left common carotid artery (LCC) supplies blood to the left side of the head and neck. A third branch originating from the aortic arch AA, the left subclavian artery (LSA), originates behind and just to the left of the left common carotid artery (LCC) and supplies blood to the left arm. The left subclavian artery (LSA) and the left common carotid artery (LCC) are distal to the brachiocephalic artery (BCA) and are sometimes referred to as aortic branch arteries distal to the brachiocephalic artery (BCA).

[0028] However, a large portion of the population has only two major branching vessels arising from the aortic arch AA, while others have four major branching vessels arising from the aortic arch AA. Thus, while a particular anatomical geometry of the aortic arch AA is shown and discussed, those skilled in the art will understand, in light of this disclosure, that the geometry of the aortic arch AA has anatomical variations and that the various structures disclosed herein will be modified accordingly.

[0029] Aneurysms, dissections, penetrating ulcers, intramural hematomas, and / or transections of the diseased region, commonly referred to as the aorta 104, may occur in the aortic arch AA and the peripheral arteries BCA, LCC, and LSA. For example, a thoracic aortic aneurysm includes an aneurysm present in the ascending thoracic aorta, the aortic arch AA, and one or more branch arteries BCA, LCC, and LSA emanating therefrom. A thoracic aortic aneurysm also includes an aneurysm present in the descending thoracic aorta and the branch arteries emanating therefrom. Thus, as Figure 1 The aorta 104 illustrated in FIG. 5 has a diseased region similar to any of those discussed above, which will be bypassed and excluded using a unibranch stent device 102 as discussed below.

[0030] The unibranch stent device 102, sometimes referred to as a prosthesis or aortic arch prosthesis, comprises a body 106 and a branch coupler 108. The branch coupler 108 is sometimes referred to as a volcano.

[0031] According to this embodiment, the body 106 includes a proximal body opening 110 at a proximal end 112 of the body 106. The body 106 further includes a distal body opening 114 at a distal end 116 of the body 106.

[0032] As used herein, the proximal end of a prosthesis (such as a unibranch stent device 102) is the end closest to the heart via the path of blood flow, while the distal end is the end farthest from the heart during deployment. In contrast and of note, the distal end of a catheter is typically identified as the end farthest from the operator / handle, while the proximal end of a catheter is the end closest to the operator / handle.

[0033] For clarity of discussion, as used herein, the distal end of the catheter is the end farthest from the operator (the end furthest from the handle), while the distal end of the unibranch stent device 102 is the end closest to the operator (the end closest to the handle), i.e., the distal end of the catheter and the proximal end of the unibranch stent device 102 are the ends farthest from the handle, while the proximal end of the catheter and the distal end of the unibranch stent device 102 are the ends closest to the handle. However, those skilled in the art will understand that, depending on the access location, the descriptions of the unibranch stent device 102 and the delivery system may be consistent or opposite in actual use.

[0034] The body 106 includes a graft material 118 and one or more circumferential stents 120 coupled to the graft material 118. The graft material 118 can be any suitable graft material, such as, but not limited to, woven polyester, material, expanded polytetrafluoroethylene, polyurethane, silicone, electrospun material or other suitable materials.

[0035] The circumferential stent 120 may be coupled to the graft material 118 using sutures or other means. Figure 1 In the embodiment shown in FIG, the circumferential stent 120 is coupled to the outer surface of the graft material 118. However, the circumferential stent 120 may alternatively be coupled to the inner surface of the graft material 118.

[0036] Although shown with a particular number of circumferential stents 120 , those skilled in the art will appreciate in light of this disclosure that the body 106 may include a greater or lesser number of stents 120 , for example, depending on the desired length of the body 106 and / or its intended application.

[0037] The circumferential stent 120 can be of any stent material or configuration. As shown, the circumferential stent 120 (e.g., a self-expanding member) is preferably made of a shape memory material (e.g., a nickel-titanium alloy (Nitinol)) and formed into a Z-shaped configuration. The configuration of the circumferential stent 120 is exemplary only, and the circumferential stent 120 can have any suitable configuration, including but not limited to a continuous or discontinuous helical configuration. In another embodiment, the circumferential stent 120 is a balloon-expandable stent.

[0038] Furthermore, the body 106 includes a longitudinal axis LA1. A lumen 122 is defined by the graft material 118 and is generally defined through the body 106. The lumen 122 is generally parallel to the longitudinal axis LA1 and extends between the proximal opening 110 and the distal opening 114 of the body 106. In this embodiment, the graft material 118 is cylindrical with a generally uniform diameter. However, in other embodiments, the diameter of the graft material 118 varies, for example, flaring or tapering.

[0039] Branch couplers 108 extend radially from body 106. Branch couplers 108 correspond to openings in body 106. Distal coupler 108 is generally frustoconical in shape and includes a base 124 and a top 126. The circumference of base 124 is greater than the circumference of top 126.

[0040] The branch coupler 108 includes a graft material 128 and one or more circumferential stents 130. The graft material 128 includes any of the graft materials discussed above with respect to the graft material 118. Additionally, the circumferential stents 130 are similar or identical to the circumferential stents 120 discussed above.

[0041] Furthermore, the branch coupler 108 includes a longitudinal axis LA2. An internal lumen 132 is defined by the graft material 128 and generally by the branch coupler 108. The internal lumen 132 is generally parallel to the longitudinal axis LA2 and extends between the bottom 124 and the top 126 of the branch coupler 108. The internal lumen 132 of the branch coupler 108 is in fluid communication with the internal lumen 122 of the body 106.

[0042] The unibranch stent device 102 is deployed, for example, via a femoral access port into the aorta 104. For example, to deploy the unibranch stent device 102, a guidewire is introduced via the femoral access port, inserted into the femoral artery and directed upward through the abdominal aorta and into the thoracic aorta.

[0043] A delivery system containing a single-branch stent device 102 is introduced via a femoral artery access port and advanced over a guidewire into the ascending aorta 104. The delivery system is positioned at a desired location such that the single-branch stent device 102 is positioned in the ascending aorta near the aortic valve AV. The single-branch stent device 102 is then deployed from the delivery system, for example, by removing a sheath that confines the single-branch stent device 102.

[0044] According to this embodiment, the unibranch stent device 102 is deployed so that the branch coupler 108 is aligned with the brachiocephalic artery (BCA). The body 106 is positioned and secured within the aorta 104 so that the proximal opening 110 is proximal to the brachiocephalic artery (BCA) and the distal opening 114 is proximal to the left common carotid artery (LCC).

[0045] Thus, blood flows into the proximal opening 110 of the body 106, flows through the lumen 122 of the body 106, and exits the distal opening 114 of the body 106 and into the aorta 104, thereby perfusing the distal region.

[0046] Furthermore, blood flow from the lumen 122 of the body 106 flows through the lumen 132 of the branch coupler 108 and into the brachiocephalic artery (BCA). More specifically, blood flow enters the bottom 124 of the branch coupler 108, passes through the lumen 132 of the branch coupler 108, and exits the top 126 of the branch coupler 108 into the brachiocephalic artery (BCA).

[0047] Figure 2 is at a later stage during deployment of a bridging stent graft 202, sometimes referred to as a bridging stent, according to one embodiment. Figure 1 Reference is now made to a cross-sectional view of a vascular assembly 100. Figure 2 , bridging stent-graft 202 is positioned within branch coupler 108 and the brachiocephalic artery BCA. More particularly, bridging stent-graft 202 is self-expanding (or balloon-expandable) to anchor within branch coupler 108 and the brachiocephalic artery BCA.

[0048] Bridging stent graft 202 includes graft material 204 and one or more circumferential stents 206. Graft material 204 includes any of the graft materials discussed above with respect to graft material 118. Additionally, circumferential stents 206 are similar or identical to circumferential stents 120, discussed above.

[0049] After deployment of the bridging stent-graft 202 , blood flow into the branch coupler 108 is bridged and passed through the bridging stent-graft 202 into the brachiocephalic artery BCA.

[0050] In one embodiment, the bridging stent-graft 202 is deployed via the femoral access port. For example, to deploy the bridging stent-graft 202, a guidewire is introduced via the femoral access port, i.e., inserted into the femoral artery and directed upward into the distal opening 114 of the body 106. The guidewire is then directed through the branch coupler 108 and into the brachiocephalic artery (BCA).

[0051] A delivery system containing bridging stent graft 202 is introduced via a femoral access port and advanced over a guidewire into branch coupler 108 and the brachiocephalic artery BCA. Bridging stent graft 202 is then deployed from the delivery system, for example, by removing a sheath that confines it.

[0052] In another embodiment, the bridging stent-graft 202 is deployed via a supra-aortic portal. For example, to deploy the bridging stent-graft 202, a guidewire is introduced through the right subclavian artery RSA and advanced through the branch coupler 108 into the body 106.

[0053] A delivery system containing bridging stent graft 202 is introduced via a supra-aortic portal and advanced over a guidewire into the brachiocephalic artery BCA and branch coupler 108. Bridging stent graft 202 is then deployed from the delivery system, for example, by removing a sheath that restrains it.

[0054] Figure 3 is a side plan view of a modular rack assembly 300 according to one embodiment. Figure 4 According to one embodiment Figure 3 A perspective view of a modular rack assembly 300 is provided.

[0055] Now let’s refer to Figure 3 and Figure 4 , modular stent device 300 (sometimes referred to as a prosthesis or aortic arch prosthesis) includes a body 302 , a bypass portal 304 , and arterial legs 306 .

[0056] According to this embodiment, the body 302 includes a proximal body opening 308 at a proximal end 310 of the body 302. The distal end 312 of the body 302 is coupled to a proximal end 314 of the bypass door 304 and a proximal end 316 of the arterial leg 306.

[0057] The bypass door 304 includes a bypass door distal opening 318 at a distal end 320 of the bypass door 304. The arterial leg 306 includes a leg distal opening 322 at a distal end 324 of the arterial leg 306. The openings 318, 322 are sometimes referred to as distal first and second openings 318, 322, respectively.

[0058] Body 302 includes graft material 326 and one or more circumferential stents 328 coupled to graft material 326. Graft material 326 includes any of the graft materials discussed above with respect to graft material 118. Additionally, circumferential stents 328 are similar or identical to circumferential stents 120, discussed above.

[0059] Furthermore, the body 302 includes a longitudinal axis LA1. A lumen 330 is defined by the graft material 326 and is generally defined through the body 302. The lumen 330 is generally parallel to the longitudinal axis LA1 and extends between the proximal opening 308 and the distal end 312 of the body 302. In this embodiment, the graft material 326 is cylindrical with a generally uniform diameter. However, in other embodiments, the diameter of the graft material 326 varies, for example, flaring or tapering.

[0060] The bypass door 304 includes a graft material 332 and one or more circumferential stents 334 coupled to the graft material 332. The graft material 332 includes any of the graft materials discussed above with respect to the graft material 118. Additionally, the circumferential stents 334 are similar or identical to the circumferential stents 120 discussed above.

[0061] Additionally, the bypass door 304 includes a longitudinal axis LA2. An internal lumen 336 is defined by the graft material 332 and generally by the bypass door 304. The internal lumen 336 is generally parallel to the longitudinal axis LA2 and extends between the proximal end 314 and the distal opening 318 of the bypass door 304. In this embodiment, the graft material 332 is cylindrical with a generally uniform diameter. However, in other embodiments, the diameter of the graft material 332 varies, for example, flaring or tapering.

[0062] Arterial limb 306 includes graft material 338 and one or more circumferential stents 340 coupled to graft material 338. Graft material 338 includes any of the graft materials discussed above with respect to graft material 118. Additionally, circumferential stents 340 are similar or identical to circumferential stents 120, discussed above.

[0063] Additionally, arterial limb 306 includes a longitudinal axis LA3. A lumen 342 is defined by graft material 338 and generally by arterial limb 306. Lumen 342 is generally parallel to longitudinal axis LA3 and extends between proximal end 316 and distal opening 322 of arterial limb 306. In this embodiment, graft material 338 is cylindrical with a generally uniform diameter. However, in other embodiments, the diameter of graft material 338 varies, for example, including a tapered or flared configuration to account for variations in patient anatomy. Furthermore, in one embodiment, limb extensions are used as needed to customize treatment to address a patient's specific anatomy.

[0064] Generally speaking, the body 302 bifurcates at the distal end 312 into the bypass door 304 and the arterial leg 306. More specifically, the lumen 330 of the body 302 bifurcates into the lumen 336 of the bypass door 304 and the lumen 342 of the arterial leg 306.

[0065] In one embodiment, the graft materials 326, 332, 338 can be the same graft material, for example, a single piece of graft material that is cut and sutured. However, in other embodiments, one or more of the graft materials 326, 332, 338 can be different from the others of the graft materials 326, 332, 338, for example, different graft materials that are cut and sutured together.

[0066] In such Figure 3 and 4 In the relaxed configuration of the modular stent device 300 , longitudinal axes LA1 , LA2 , and LA3 are shown parallel to one another, such that the bypass portal 304 and arterial leg 306 extend distally from the body 302 .

[0067] The body 302 has a first diameter D1, the bypass gate 304 has a second diameter D2, and the arterial leg 306 has a third diameter D3. According to this embodiment, the first diameter D1 is greater than the second diameter D2. Furthermore, the second diameter D2 is greater than the third diameter D3. According to this embodiment, the first diameter D1 is greater than the second diameter D2 combined with the third diameter D3 (D1>D2+D3), such that the bypass gate 304 and the arterial leg 306 are located within an imaginary cylindrical shape defined by the graft material 326 of the body 302 extending in the distal direction. The parallel design simulates anatomical vascular bifurcations to limit flow disruption.

[0068] In one embodiment, at the distal end 312 and the proximal ends 314, 316 (sometimes referred to as the transition region), the first diameter D1 is greater than the second diameter D2 combined with the third diameter D3 (D1>D2+D3). However, according to another embodiment, the body 302, the bypass door 304, and / or the arterial leg 306 flare or taper away from the transition region, so that D1>D2+D3 at the transition region, but this is not necessarily true in areas away from the transition region. Figure 3 Indicated by the dotted line.

[0069] In other words, the transition area from the main body 302 to the arterial legs 306 and the bypass door 304 does not exceed the first diameter D1 of the main body 302. This ensures that the arterial legs 306 and the bypass door 304 do not press against each other or negatively impact flow in any way. By avoiding extending the arterial legs 306 and the bypass door 304 beyond the width of the main body 302, a good seal of the stent 328 from the main body 302 is ensured, and endoleaks are minimized or avoided.

[0070] According to one embodiment, the transition area between the body 302 and the arterial legs 306 and bypass portal 304 is fully supported by one or more support stents, such as stents 328, 334, 340, to prevent kinking in angled anatomy.

[0071] The body 302 has a first length L1 in a direction parallel to the longitudinal axis LA1, the bypass door 304 has a second length L2 in a direction parallel to the longitudinal axis LA2, and the arterial leg 306 has a third length L3 in a direction parallel to the longitudinal axis LA3. According to this embodiment, the third length L3 is greater than the second length L2, such that the distal opening 322 of the arterial leg 306 is distal to the distal opening 318 of the bypass door 304. Generally speaking, the arterial leg 306 is longer than the bypass door 304.

[0072] Although fixed diameters D1, D2, and D3 are shown and discussed, in one embodiment, the diameters of the body 302, bypass door 304, and / or arterial legs 306 are non-uniform. For example, the body 302 is flared or tapered at the proximal end 310. Similarly, the bypass door 304 and / or arterial legs 306 are flared or tapered at the distal ends 320, 324, respectively. For example, the bypass door 304 and / or arterial legs 306 are flared or tapered at the distal ends 320, 324 to enhance sealing.

[0073] The arterial legs 306 are configured to exert a radial force higher than the radial force of the bypass door 304. As used herein, "radial force" encompasses the radial force exerted during expansion / deployment, as well as the chronic radial force continuously exerted after implantation, so that the architecture has a predetermined compliance or resistance as the surrounding native anatomy (e.g., the aorta 104) expands and contracts during the cardiac cycle. The radial force of the bypass door 304 is configured to be lower than the radial force of the arterial legs 306 to avoid collapse of the arterial legs 306 when the bypass door 304 is deployed against and adjacent thereto, and thereby maintain perfusion through the arterial legs 306, as discussed further below.

[0074] To configure the bypass door 304 and arterial limb 306 with different relative radial forces, the circumferential stent 340 of the arterial limb 306 is constructed with relatively thicker and / or shorter material segments compared to the circumferential stent 334 of the bypass door 304. The shorter and / or thicker circumferential stent 340 has less flexibility but a greater radial force to ensure that the circumferential stent 334 of the bypass door 304 does not collapse the lumen 342 of the arterial limb 306. In other embodiments, other variations or modifications of the circumferential stents 334, 340 can be used to achieve the relative radial forces.

[0075] Modular stent device 300 further includes radiopaque markers 350, 352, 354. According to this embodiment, radiopaque marker 350 is shaped as a figure-8 marker, i.e., in the shape of the number 8. Radiopaque marker 350 is sewn into graft material 326 in line with arterial limb 306. Under fluoroscopy, radiopaque marker 350 is rotated so that, in one embodiment, it is visible on the edge of the outer curvature of aortic arch AA, allowing accurate and reproducible deployment of arterial limb 306 on the outer curve of aorta 104.

[0076] Radiopaque markers 352 are sewn into the transition area where the body 302 meets the bypass door 304 and arterial legs 306 to indicate the desired degree of overlap. Radiopaque markers 354 (e.g., coil markers) are sewn into the bypass door 304 to assist in cannulation of the bypass door 304.

[0077] Figure 5 According to one embodiment, Figure 3 and Figure 4 The modular stent assembly 300 is deployed at a later stage during Figure 2FIG2 is a cross-sectional view of a vascular assembly 100 of FIG2. According to this embodiment, the arterial leg 306 of the modular stent device 300 is deployed within the left subclavian artery (LSA) via a supra-aortic portal through the left subclavian artery (LSA). The bypass portal 304 of the modular stent device 300 is positioned within the aorta 104 and is arranged to point distally away from the unibranch stent device 102. The body 302 of the modular stent device 300 is positioned within the body 106 of the unibranch stent device 102 and distal to the branch coupler 108.

[0078] According to this embodiment, blood flow enters the modular stent device 300 from the main body 106 of the unibranch stent device 102 through the body 302 and exits through the bypass door 304 and the arterial leg 306. Thus, blood flow through the arterial leg 306 and perfusion of the left subclavian artery (LSA) are ensured. In this way, any overlapping diseased area of ​​the aorta 104 is excluded.

[0079] According to this embodiment, the modular stent device 300 overlaps, excludes, and thus occludes the left common carotid artery LCC. According to this embodiment, the bypass 502 provides perfusion to the left common carotid artery LCC. Illustratively, the bypass 502 provides perfusion to the left common carotid artery LCC from the left subclavian artery LSA.

[0080] The shunt 502 is surgically inserted during the same procedure as deployment of the unibranch stent device 102, 300. However, in another embodiment, for example, to simplify the procedure, the shunt 502 is surgically inserted before the stent device 102, 300 is deployed.

[0081] Figure 6 The final stage during deployment of the tube graft 602 into the modular stent device 300 and the proximal hoop 612 into the unibranch stent device 102 is shown in FIG. Figure 5 A cross-sectional view of the vascular assembly 100 is shown. Figure 6 , the tube graft 602 is deployed into and attached to the bypass portal 304 and the aorta 104 .

[0082] Tube graft 602 includes graft material 604 and one or more circumferential stents 606. Graft material 604 includes any of the graft materials discussed above with respect to graft material 118. Additionally, circumferential stents 606 are similar or identical to circumferential stents 120, discussed above.

[0083] In addition, if Figure 6As shown, optionally, a proximal cuff 612 is coupled to and extends proximally from the body 106 of the unibranch stent device 102. For example, the proximal cuff 612 is deployed when the proximal end 112 of the body 106 is deployed distally from the aortic valve AV to extend between the desired deployment location and the proximal end 112 of the body 106. The proximal cuff 612 is optional and, in one embodiment, is not deployed or used.

[0084] The proximal cuff 612 includes a graft material 614 and one or more circumferential stents 616. The graft material 614 includes any of the graft materials discussed above with respect to the graft material 118. Additionally, the circumferential stents 616 are similar or identical to the circumferential stents 120 discussed above.

[0085] Figure 7 According to another embodiment, Figure 3 and Figure 4 The modular stent assembly 300 is deployed at a later stage during Figure 2 A cross-sectional view of the vascular assembly 100 is shown. Figure 8 The final stage during deployment of the tube graft 602 into the modular stent device 300 and the proximal hoop 612 into the unibranch stent device 102 is shown in FIG. Figure 7 A cross-sectional view of the vascular assembly 100 is shown. Figure 7 and Figure 8 Similar to Figure 5 and Figure 6 , and only significant differences are discussed below.

[0086] Now refer to Figure 7 and Figure 8 The arterial leg 306 of the modular stent device 300 is deployed in the left common carotid artery LCC via the supra-aortic access port, thereby ensuring blood flow through the arterial leg 306 and perfusion of the left common carotid artery LCC.

[0087] According to this embodiment, the tube graft 602 and / or modular stent device 300 overlaps, excludes, and thereby occludes the left subclavian artery (LSA). According to this embodiment, the bypass 502 provides perfusion to the left subclavian artery (LSA). Schematically, the bypass 502 provides perfusion to the left subclavian artery (LSA) from the left common carotid artery (LCC).

[0088] Figure 9 is a side plan view of a modular rack assembly 900 according to another embodiment. Figure 10 According to one embodiment Figure 9 A perspective view of the modular support device 900 is now shown. Figure 9 and Figure 10, the modular stent device 900 includes a body 902 , a bypass door 904 , and an arterial leg 906 .

[0089] According to this embodiment, the body 902 includes a proximal body opening 908 at a proximal end 910 of the body 902. The distal end 912 of the body 902 is coupled to a proximal end 914 of the bypass door 904 and a proximal end 916 of the arterial leg 906.

[0090] The bypass door 904 includes a bypass door distal opening 918 at a distal end 920 of the bypass door 904. The arterial leg 906 includes a leg distal opening 922 at a distal end 924 of the arterial leg 906. The openings 918, 922 are sometimes referred to as distal first and second openings 918, 922, respectively.

[0091] Body 902 includes graft material 926 and one or more circumferential stents 928 coupled to graft material 926. Graft material 926 includes any of the graft materials discussed above with respect to graft material 118. Additionally, circumferential stents 928 are similar or identical to circumferential stents 120, discussed above.

[0092] Additionally, the body 902 includes a longitudinal axis LA1. A lumen 930 is defined by the graft material 926 and is generally defined through the body 902. The lumen 930 is generally parallel to the longitudinal axis LA1 and extends between the proximal opening 908 and the distal end 912 of the body 902. In this embodiment, the graft material 926 is cylindrical with a generally uniform diameter. However, in other embodiments, the diameter of the graft material 926 varies, for example, flaring or tapering.

[0093] The bypass door 904 includes a graft material 932 and one or more circumferential stents 934 coupled to the graft material 932. The graft material 932 includes any of the graft materials discussed above with respect to the graft material 118. Additionally, the circumferential stents 934 are similar or identical to the circumferential stents 120 discussed above.

[0094] Additionally, the bypass door 904 includes a longitudinal axis LA2. An internal lumen 936 is defined by the graft material 932 and generally by the bypass door 904. The internal lumen 936 is generally parallel to the longitudinal axis LA2 and extends between the proximal end 914 and the distal opening 918 of the bypass door 904. In this embodiment, the graft material 932 is cylindrical with a generally uniform diameter. However, in other embodiments, the diameter of the graft material 932 varies, for example, tapering or flaring.

[0095] Arterial limb 906 includes graft material 938 and one or more circumferential stents 940 coupled to graft material 938. Graft material 938 includes any of the graft materials discussed above with respect to graft material 118. Additionally, circumferential stents 940 are similar or identical to circumferential stents 120, discussed above.

[0096] Additionally, arterial limb 906 includes a longitudinal axis LA3. A lumen 942 is defined by graft material 938 and generally by arterial limb 906. Lumen 942 is generally parallel to longitudinal axis LA3 and extends between proximal end 916 and distal opening 922 of arterial limb 906. In this embodiment, graft material 938 is cylindrical with a generally uniform diameter. However, in other embodiments, the diameter of graft material 938 varies, for example, flaring or tapering.

[0097] Generally speaking, the body 902 bifurcates at the distal end 912 into a bypass portal 904 and an arterial leg 906. More specifically, the lumen 930 of the body 902 bifurcates into a lumen 936 of the bypass portal 904 and a lumen 942 of the arterial leg 906. In one embodiment, the graft materials 926, 932, 938 can be the same graft material, for example, a single piece of graft material that is cut and sutured. However, in other embodiments, one or more of the graft materials 926, 932, 938 can be different from the others of the graft materials 926, 932, 938, for example, different graft materials that are cut and sutured together.

[0098] In such Figure 9 and 10 The modular stent device 900 is shown in a relaxed (unstressed) configuration with longitudinal axes LA1 , LA2 , and LA3 parallel to one another such that the bypass portal 904 and arterial legs 906 extend distally from the body 902 .

[0099] The body 902 has a first diameter D1, the bypass door 904 has a second diameter D2, and the arterial leg 906 has a third diameter D3. According to this embodiment, the first diameter D1 is greater than the second diameter D2. Furthermore, the second diameter D2 is greater than the third diameter D3. According to this embodiment, the first diameter D1 is greater than the second diameter D2 combined with the third diameter D3 (D1>D2+D3), such that the bypass door 904 and the arterial leg 906 are located within an imaginary cylinder defined by the graft material 926 of the body 902 extending in the distal direction. The parallel design simulates anatomical vascular bifurcations to limit flow disruption.

[0100] In one embodiment, at the distal end 912 and the proximal ends 914, 916 (sometimes referred to as the transition region), the first diameter D1 is greater than the second diameter D2 combined with the third diameter D3 (D1>D2+D3). However, according to another embodiment, the body 902, the bypass door 904, and / or the arterial leg 906 flare or taper away from the transition region, so that D1>D2+D3 at the transition region, but this is not necessarily true in areas away from the transition region. The flaring is caused by Figure 9 Indicated by the dotted line.

[0101] In other words, the transition area from the body 902 to the arterial legs 906 and the bypass door 904 does not exceed the first diameter D1 of the body 902. This ensures that the arterial legs 906 and the bypass door 904 do not press against each other or negatively impact flow in any way. By avoiding extending the arterial legs 906 and the bypass door 904 beyond the width of the body 902, a good seal of the stent 928 from the body 902 is ensured, and endoleaks are minimized or avoided.

[0102] According to one embodiment, the transition area between the body 902 and the arterial legs 906 and bypass portal 904 is fully supported by one or more support stents, such as stents 928, 934, 940, to prevent kinking in angled anatomies.

[0103] The body 902 has a first length L1 in a direction parallel to the longitudinal axis LA1, the bypass door 904 has a second length L2 in a direction parallel to the longitudinal axis LA2, and the arterial leg 906 has a third length L3 in a direction parallel to the longitudinal axis LA3. According to this embodiment, the third length L3 is greater than the second length L2, such that the distal opening 922 of the arterial leg 906 is distal to the distal opening 918 of the bypass door 904. Generally speaking, the arterial leg 906 is shorter than the bypass door 904.

[0104] Although fixed diameters D1, D2, and D3 are shown and discussed, in one embodiment, the diameters of the body 902, bypass door 904, and / or arterial legs 906 are non-uniform. For example, the body 902 is flared or tapered at the proximal end 910. Similarly, the bypass door 904 and / or arterial legs 906 are flared or tapered at the distal ends 920, 924, respectively. For example, the bypass door 904 and / or arterial legs 906 are flared or tapered at the distal ends 920, 924 to enhance sealing.

[0105] Arterial legs 906 are configured to exert a higher radial force than the radial force of bypass door 904. The radial force of bypass door 904 is configured to be lower than the radial force of arterial legs 906 to avoid collapse of arterial legs 906 when bypass door 904 is deployed against and adjacent thereto, and thereby maintain perfusion through arterial legs 906, as discussed further below.

[0106] To configure the bypass door 904 and arterial limb 906 with different relative radial forces, the circumferential stent 940 of the arterial limb 906 is constructed with relatively thicker and / or shorter material segments compared to the circumferential stent 934 of the bypass door 904. The shorter and / or thicker circumferential stent 940 has less flexibility but a greater radial force to ensure that the circumferential stent 934 of the bypass door 904 does not collapse the lumen 942 of the arterial limb 906. In other embodiments, other variations or modifications of the circumferential stents 934, 940 can be used to achieve the relative radial forces.

[0107] Modular stent device 900 includes radiopaque markers 950, 952, 954. According to this embodiment, radiopaque marker 950 is shaped as a figure-8 marker, i.e., in the shape of the number 8. Radiopaque marker 950 is sewn into graft material 926 in line with arterial limb 906. Under fluoroscopy, radiopaque marker 950 is rotated so that, in one embodiment, it is visible on the edge of the outer curvature of the aortic arch, allowing accurate and reproducible deployment of arterial limb 906 on the outer curve of aorta 104.

[0108] Radiopaque markers 952 are sewn into the transition area where the body 902 meets the bypass door 904 and arterial legs 906 to indicate the desired degree of overlap. Radiopaque markers 954 (e.g., coil markers) are sewn into the bypass door 904 to assist in cannulation of the bypass door 904.

[0109] Figure 11 According to another embodiment, Figure 9 and Figure 10 The modular stent assembly 900 is positioned at a later stage during deployment of the Figure 2 A cross-sectional view of the vascular assembly 100 is shown.

[0110] According to this embodiment, the modular stent device 900 is deployed via the femoral access port within the body 106 of the unibranch stent device 102. For example, to deploy the modular stent device 900, a guidewire is introduced via the femoral access port, i.e., inserted into the femoral artery and directed upward through the abdominal aorta and into the body 106 of the unibranch stent device 102.

[0111] A delivery system including the modular stent device 900 is introduced via a femoral artery access port and advanced over a guidewire into the body 106 of the single-branch stent device 102. The delivery system is positioned at the desired location. The modular stent device 900 is then deployed from the delivery system, for example, by removing a sheath that confines the modular stent device 900.

[0112] More specifically, the bypass door 904 of the modular stent device 900 is positioned within the aorta 104 and is disposed distally and away from the unibranch stent device 102. The body 902 of the modular stent device 900 is positioned within the body 106 of the unibranch stent device 102 and distal to the branch coupler 108. The distal opening 922 of the arterial leg 906 is proximal to the left common carotid artery (LCC) and the left subclavian artery (LSA).

[0113] Figure 12 is at a later stage during deployment of a bridging stent graft 1202, sometimes referred to as a bridging stent, according to one embodiment. Figure 11 A cross-sectional view of the vascular assembly 100 is provided. Figure 11 and Figure 12 , bridging stent-graft 1202 is deployed within arterial leg 906 and the left subclavian artery LSA. More particularly, bridging stent-graft 1202 is self-expanding (or balloon-expandable) to anchor within arterial leg 906 and the left subclavian artery LSA. Bridging stent-graft 1202 is deployed through the left subclavian artery LSA via a supra-aortic access point or, alternatively, a femoral access point.

[0114] Bridging stent graft 1202 comprises graft material 1204 and one or more circumferential stents 1206. After deployment of bridging stent graft 1202, blood flow entering coupling 906 is bridged and passed through bridging stent graft 1202 into the left subclavian artery (LSA). In this way, any overlapping diseased areas of aorta 104 are excluded.

[0115] According to this embodiment, the modular stent device 900 and / or the bridging stent graft 1202 overlap, exclude, and thus occlude the left common carotid artery LCC. According to this embodiment, the bypass 502 provides perfusion to the left common carotid artery LCC. Illustratively, the bypass 502 provides perfusion to the left common carotid artery LCC from the left subclavian artery LSA.

[0116] Figure 13 The final stage during deployment of the tube graft 1302 into the modular stent device 900 and the proximal hoop 612 into the unibranch stent device 102 is shown in FIG. Figure 12 A cross-sectional view of the vascular assembly 100 is shown. Figure 13 , tube graft 1302 is deployed into and attached to the bypass portal 904 and aorta 104 .

[0117] Tube graft 1302 includes graft material 1304 and one or more circumferential stents 1306. Graft material 1304 includes any of the graft materials discussed above with respect to graft material 118. Additionally, circumferential stents 1306 are similar or identical to circumferential stents 120, discussed above.

[0118] In addition, if Figure 13 As shown, optionally, the proximal cuff 612 is similar to the above Figure 6 The discussed manner is coupled to and extends proximally from the body 106 of the unibranch stent device 102 and, therefore, will not be repeated here for the sake of brevity.

[0119] Figure 14 For later stages during deployment of the bridging stent graft 1402 according to one embodiment Figure 11 A cross-sectional view of the vascular assembly 100 is shown.

[0120] Reference together Figure 11 and Figure 14 , bridging stent-graft 1402 is deployed within arterial limb 906 and the left common carotid artery LCC. More specifically, bridging stent-graft 1402 is self-expanding (or balloon-expandable) to anchor within arterial limb 906 and the left common carotid artery LCC. Bridging stent-graft 1402 is deployed via a supra-aortic access port through the left common carotid artery LCC or through a femoral access port in a manner similar to that discussed above with respect to bridging stent-graft 1202.

[0121] Bridging stent graft 1402 comprises graft material 1404 and one or more circumferential stents 1406. Upon deployment of bridging stent graft 1402, blood flow entering arterial leg 906 is bridged and routed through bridging stent graft 1402 into the left common carotid artery (LCC). In this manner, any overlapping diseased area of ​​aorta 104 is excluded.

[0122] According to this embodiment, the modular stent device 900 and / or the bridging stent graft 1402 overlap, exclude, and thus occlude the left subclavian artery (LSA). According to this embodiment, the bypass 502 provides perfusion to the left subclavian artery (LSA). Schematically, the bypass 502 provides perfusion to the left subclavian artery (LSA) from the left common carotid artery (LCC).

[0123] Figure 15 The final stage during deployment of the tube graft 1302 into the modular stent device 900 and the proximal hoop 612 into the unibranch stent device 102 is shown in FIG. Figure 14 A cross-sectional view of the vascular assembly 100 is shown. Figure 15, the tube graft 1302 is deployed into and attached to the bypass portal 904 and the aorta 104. In addition, as Figure 15 As shown, optionally, a proximal hoop 612 is coupled to and extends proximally from the body 106 of the unibranch stent device 102. The tube graft 1302 and the proximal hoop 612 and their deployment are similar to those described above with respect to Figure 13 discussed, and therefore will not be repeated here for the sake of brevity.

[0124] Figure 16 According to another embodiment, similar to Figure 6 Referring now to FIG. 1 , a cross-sectional view of a vascular assembly 100A of FIG. Figure 16 To increase and / or provide sufficient overlap between the unibranch device 102 and the body 302 of the modular stent device 300, the body 106 extends distally past the brachiocephalic artery (BCA), for example, distally past the left common carotid artery (LCC). This provides additional overlap within the body 106 distally past the branch coupler 108 for modular connection between the unibranch device 102 and the modular stent device 300 to withstand the dynamic motion of the aortic arch AA.

[0125] In addition, if Figure 6 As shown, the bypass door 304 is flared to seal against the aorta 104. Figure 16 In the bypass gate 304, Figure 6 The short one shown in FIG. 1 is, for example, at or near the left subclavian artery LSA, and the tube graft 602 provides a seal with the aorta 104 .

[0126] Figure 17 A branch coupler 108 having misalignment with the brachiocephalic artery BCA according to one embodiment Figure 2 A cross-sectional view of a region of the vascular assembly 100 is now shown. Figure 17 To increase and / or provide sufficient overlap between the unibranch device 102 and the body 302 of the modular stent device 300, the branch coupler 108 is located proximal to the brachiocephalic artery (BCA). The bridging stent graft 202 bridges the displacement between the branch coupler 108 and the brachiocephalic artery (BCA). This provides additional overlap within the body 106 distally past the branch coupler 108 for a modular connection between the unibranch device 102 and the modular stent device 300 to withstand the dynamic movement of the aortic arch AA.

[0127] This application is related to: U.S. patent application serial number 16 / 367,889, filed on March 28, 2019, by Perkins et al., entitled “Modular Stent Apparatus and Methods for Multiple Vessels”; U.S. patent application serial number 16 / 367,906, filed on March 28, 2019, by Perkins et al., entitled “Supra-Aortic Portal Modular Stent Assembly and Methods”; U.S. patent application serial number 16 / 367,922, filed on March 28, 2019, by Perkins et al., entitled “Femoral Portal Modular Stent Assembly and Methods”; and U.S. Patent No. 9,839,542, issued on December 12, 2017, by Bruszewski et al., the disclosures of which are incorporated herein by reference in their entirety.

[0128] It should be understood that the various aspects disclosed herein may be combined in combinations different from those specifically presented in the specification and drawings. It should also be understood that, depending on the example, certain actions or events of any of the processes or methods described herein may be performed in a different order, may be added, combined, or omitted entirely (e.g., all described actions or events may not be necessary for performing these techniques). In addition, although certain aspects of the present disclosure are described as being performed by a single module or unit for purposes of clarity, it should be understood that the technology of the present disclosure may be performed by a combination of units or modules associated with, for example, a medical device.

Claims

1. A vascular assembly comprising: A single-branch stent device, comprising: a main body of a unibranch stent device; and a branch coupler extending radially from a body of the unibranch stent device, wherein a proximal end of the unibranch stent device is configured to seal in the ascending aorta; and A modular stent device comprising a proximal end configured to be coupled to a distal end of the unibranch stent device, the modular stent device comprising: a body of a modular stent device, the body of the modular stent device being configured to be coupled within the body of the unilimb stent device; a bypass door extending distally from a distal end of the body of the modular stent device; and an arterial leg extending distally from the distal end of the body of the modular stent device, wherein the body of the modular stent device has a first longitudinal axis, the bypass portal has a second longitudinal axis, and the arterial limb has a third longitudinal axis, the first, second, and third longitudinal axes being parallel to one another when the modular stent device is in a relaxed configuration; wherein the body of the modular stent device has a first diameter, the bypass gate has a second diameter, and the arterial limb has a third diameter, wherein the first diameter is greater than the second diameter and the third diameter combined at a transition region where the body of the modular stent device meets the bypass gate and the arterial limb.

2. The vascular assembly of claim 1, wherein the stent of the arterial leg has a radial force greater than the radial force of the bypass gate.

3. The vascular assembly of claim 1, wherein the length of the arterial leg is greater than the length of the bypass gate.

4. The vascular assembly of claim 3, wherein the length of the arterial leg is measured along the third longitudinal axis and the length of the bypass gate is measured along the second longitudinal axis.

5. The vascular assembly of claim 1, wherein the length of the arterial leg is less than the length of the bypass gate.

6. The vascular assembly of claim 5, further comprising a bridging stent graft configured to be coupled to the arterial limb.

7. The vascular assembly of claim 1, wherein the bypass gate and the arterial leg are located within an imaginary cylinder defined by the body of the modular stent device extending in a distal direction at the transition region.

8. The vascular assembly of claim 1, wherein the stent of the arterial leg has a greater radial force than the stent of the bypass gate.

9. The vascular assembly of claim 1, wherein the bypass gate is configured to collapse relative to the arterial leg.

10. The vascular assembly of claim 1, further comprising a tube graft configured to couple to the bypass portal and extend distally therefrom.

11. The vascular assembly of claim 1 , further comprising a proximal cuff configured to couple to and extend proximally from the body of the unibranch stent device.

12. The vascular assembly of claim 1, further comprising a bridging stent graft configured to be coupled to the branch coupler.

13. The vascular assembly of claim 1, wherein the branch coupler is disposed at the distal end of the single-branch stent device.

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