Docking graft and method for placement of distally extending parallel graft components

Abstract

The technology disclosed herein generally relates to an assembly including a docking graft. The docking graft includes a main graft defining a main lumen, a first lumen within the main lumen, a second lumen within the main lumen, and a main docking lumen within the main lumen. The first and second lumens are configured to receive first and second bridging stent grafts therein. The main docking lumen is configured to receive a tube graft therein. When the docking graft is in a relaxed configuration, the first lumen, the second lumen, and the main docking lumen are parallel to one another and extend the entire length of the docking graft. The docking graft forms a foundation or anchoring device for connecting the first bridging stent graft, the second bridging stent graft, and the tube graft within the aorta.

Description

Technical Field

[0001] The present technology generally relates to intravascular devices and methods. More specifically, the present application relates to devices 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 section of the aorta is not without its 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 conduit for blood to flow through the diseased section. Summary of the Invention

[0005] The technology disclosed herein generally relates to an assembly comprising a docking graft. The docking graft comprises a main graft defining a main lumen, a first lumen within the main lumen, a second lumen within the main lumen, and a main docking lumen within the main lumen. The first lumen is configured to receive a first bridging stent graft therein, and the second lumen is configured to receive a second bridging stent graft therein. The main docking lumen is configured to receive a tube graft therein. The first lumen, the second lumen, and the main docking lumen are parallel to each other and extend the entire length of the docking graft from a proximal end of the docking graft to a distal end of the docking graft when the docking graft is in a relaxed (unstressed) configuration. The docking graft forms a base or anchoring device for connecting the first bridging stent graft, the second bridging stent graft, and the tube graft within the aorta.

[0006] In one aspect, the present disclosure provides an assembly comprising a docking graft. The docking graft includes a main graft defining a main lumen, a first inner sleeve defining a first lumen within the main lumen, and a second inner sleeve defining a second lumen within the main lumen. The main lumen, the first lumen, and the second lumen are parallel to each other and extend the entire length of the docking graft from a proximal end to a distal end of the docking graft when the docking graft is in a relaxed configuration.

[0007] In yet another aspect, the present disclosure provides a method comprising deploying a dock graft within the ascending aorta. The dock graft includes a main graft defining a main lumen, a first lumen within the main lumen, a second lumen within the main lumen, and a main dock lumen within the main lumen. A first bridging stent graft is deployed within the first lumen, a second bridging stent graft is deployed within the second lumen, and a tube graft is deployed within the main dock lumen. The first bridging stent graft, the second bridging stent graft, and the tube graft are parallel to each other within the dock graft and extend distally from the dock graft.

[0008] The details of one or more aspects of the disclosure are set forth in the accompanying drawings and the description below. 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 side perspective view of a docking graft according to one embodiment.

[0010] Figure 2 According to one embodiment Figure 1 Top perspective view of a docking graft.

[0011] Figure 3 According to one embodiment Figure 1 Plan view of the proximal end of the docking graft of line III.

[0012] Figure 4 According to one embodiment Figure 1 Plan view of the distal end of the line IV docking graft.

[0013] Figure 5 is a top perspective view of a cannula docking a graft according to one embodiment.

[0014] Figure 6 According to another embodiment Figure 1-2 A partial cross-sectional view of a docking graft perpendicular to the longitudinal axis of the main graft.

[0015] Figure 7 is a vascular assembly including a docking graft after deployment, according to one embodiment.

[0016] Figure 8 For a later stage during deployment of a bridging stent graft according to one embodiment Figure 7 Cross-sectional view of the vascular components.

[0017] Figure 9 For a later stage during deployment of a bridging stent graft according to one embodiment Figure 8 Lateral plan view of the vascular assembly.

[0018] Figure 10 According to one embodiment Figure 9 Cross-sectional view of the vascular assembly at the final stage during deployment of the tube graft.

[0019] Figure 11 For a later stage during deployment of a bridging stent graft according to another embodiment Figure 8 Lateral plan view of the vascular assembly.

[0020] Figure 12 According to one embodiment Figure 7 Cross-sectional view of the vascular assembly at a later stage during deployment of a bifurcated graft.

[0021] Figure 13 For a later stage during deployment of a bridging stent graft according to another embodiment Figure 12 Lateral plan view of the vascular assembly.

[0022] Figure 14 For later stages during deployment of a bridging graft and tube graft according to one embodiment Figure 13 Cross-sectional view of the vascular components. DETAILED DESCRIPTION

[0023] Figure 1 is a side perspective view of a docking graft 100 according to one embodiment. Figure 2 According to one embodiment Figure 1 1. A top perspective view of a docking graft 100 is shown. The docking graft 100, sometimes referred to as a prosthesis and / or a trifurcated device, includes a main graft 102, a first inner sleeve 104, and a second inner sleeve 106. The docking graft 100 includes a proximal end 108 and a distal end 110.

[0024] As used herein, the proximal end of a prosthesis (e.g., docking graft 100) 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 worth noting, 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.

[0025] For clarity of discussion, as used herein, the distal end of the catheter is the end farthest from the operator (the end farthest from the handle), while the distal end of the docking graft 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 docking graft 100 are the ends farthest from the handle, while the proximal end of the catheter and the distal end of the docking graft 100 are the ends closest to the handle. However, one skilled in the art will understand that, depending on the access point, the description of the docking graft 100 and the delivery system may be consistent or reversed in actual use.

[0026] The main graft 102 includes a graft material 112 and one or more annular stents 114 coupled to the graft material 112. The graft material 112 may be any suitable graft material, such as, but not limited to, braided polyester, material, expanded polytetrafluoroethylene, polyurethane, silicone, electrospun material or other suitable materials.

[0027] The ring stent 114 can be attached to the graft material 112 using sutures or other means. Figure 1 In the embodiment shown in FIG, the ring-shaped support 114 is coupled to the outer surface of the graft material 112. However, the ring-shaped support 114 can also be coupled to the inner surface of the graft material 112. Figure 2 , to allow visualization of the cannulas 104 , 106 .

[0028] Although a particular number of annular stents 114 are shown, those skilled in the art will appreciate in light of this disclosure that the main graft 102 may include a greater or lesser number of stents 114 , eg, depending on the desired length of the main graft 102 and / or its intended application.

[0029] The annular stent 114 can be any stent material or configuration. As shown, the annular stent 114, such as a self-expanding member, is preferably made of a shape memory material, such as nickel titanium alloy (Nitinol), and is formed into a zigzag configuration. The configuration of the annular stent 114 is merely exemplary, and the annular stent 114 can have any suitable configuration, including but not limited to a continuous or discontinuous spiral configuration. In another embodiment, the annular stent 114 is a balloon-expandable stent.

[0030] Furthermore, the main graft 102 includes a proximal opening 116 at the proximal end 108 of the dock graft 100, a distal opening 118 at the distal end 110 of the dock graft 100, and a longitudinal axis LA1. A lumen 120, sometimes referred to as a main lumen, is defined by the graft material 112 and, generally, by the main graft 102. Lumen 120 is generally parallel to the longitudinal axis LA1 and extends between the proximal opening 116 and the distal opening 118 of the main graft 102. In this embodiment, the graft material 112 is cylindrical with a substantially uniform diameter. However, in other embodiments, the diameter of the graft material 112 varies.

[0031] Figure 3 According to one embodiment Figure 1 A plan view of the proximal end 108 of the docking graft 100 is shown along line III. Figure 4 According to one embodiment Figure 1 A plan view of the distal end 110 of the docking graft 100 of line IV.

[0032] Reference together Figure 1-4 , the first inner sleeve 104 and the second inner sleeve 106 are positioned within the main graft 102, ie, are attached to the inner surface of the graft material 112 and are generally attached to the inner surface of the main graft 102. The sleeves 104, 106 are positioned within the lumen 120 of the main graft 102.

[0033] The first inner cannula 104 includes a proximal opening 122 at the proximal end 108 of the docking graft 100, a distal opening 124 at the distal end 110 of the docking graft 100, and a longitudinal axis LA2. A lumen 126, sometimes referred to as a first lumen 126, is defined by the first inner cannula 104. The lumen 126 is generally parallel to the longitudinal axis LA2 and extends between the proximal opening 122 and the distal opening 124 of the first inner cannula 104.

[0034] Similarly, the second inner cannula 106 includes a proximal opening 128 at the proximal end 108 of the docking graft 100, a distal opening 130 at the distal end 110 of the docking graft 100, and a longitudinal axis LA3. A lumen 132, sometimes referred to as a second lumen 132, is defined by the second inner cannula 106. The lumen 132 is generally parallel to the longitudinal axis LA3 and extends between the proximal opening 128 and the distal opening 130 of the second inner cannula 106.

[0035] According to this embodiment, the longitudinal axes LA1, LA2, and LA3 are parallel to one another. Generally, the lumens 120, 126, 132 of the main graft 102, the first inner sleeve 104, and the second inner sleeve 106 are parallel to one another and extend the entire length of the docking graft 100 between the proximal end 108 and the distal end 110 when the docking graft 100 is in a relaxed (unstressed) configuration.

[0036] Figure 5 is a top perspective view of sleeves 104, 106 of a docking graft 100 according to one embodiment. Figure 1-5 , sleeves 104, 106 include graft material 134, 136 and one or more stents 138, 140, respectively. Graft material 134, 136 is the same as or similar to graft material 112 described above. Additionally, stents 138, 140 are the same as or similar to stent 114 described above.

[0037] Graft materials 134, 136 define the lumens 126, 132, respectively, of the sleeves 104, 106. Stents 138, 140 ensure that the lumens 126, 132 remain open and accessible for docking a branch graft therein, as discussed further below.

[0038] In this embodiment, the graft material 134, and generally the first inner cannula 104, are cylindrical with a substantially uniform diameter D1. However, in other embodiments, the diameter of the graft material 134, and generally the first inner cannula 104, varies.

[0039] Similarly, in this embodiment, the graft material 136, and generally the second inner cannula 106, are cylindrical with a substantially uniform diameter D2. However, in other embodiments, the diameter of the graft material 136, and generally the second inner cannula 106, varies.

[0040] According to this embodiment, diameters D1 and D2 are equal, but in other embodiments diameter D1 is larger or smaller than diameter D2, for example, depending on the branch graft to be positioned within cannulas 104, 106 and the blood vessels to be perfused therethrough.

[0041] According to this embodiment, the inner sleeves 104, 106 are adjacent, e.g., attached, to each other along the entire length of the inner sleeves 104, 106. The inner sleeves 104, 106 are attached to the graft material 112, and typically to the main graft 102, by attachment means 142. The attachment means 142 includes sutures, adhesives, or other suitable attachment means.

[0042] According to this embodiment, the cavities 126, 132 are completely defined by the graft material 134, 136. In other words, the graft material 134, 136 is cylindrical and completely surrounds the cavities 126, 132. However, in other embodiments, such as those described below with reference to Figure 6 In the embodiment discussed, the graft materials 124 , 136 , in combination with the graft material 112 , define the cavities 126 , 132 .

[0043] Figure 6 According to another embodiment Figure 1-2 A partial cross-sectional view of the docking graft 100 perpendicular to the longitudinal axis LA1 of the main graft 102. Figure 1-4 6, the first inner sleeve 104, in combination with the main graft 102, defines a lumen 126. More specifically, the graft material 134 of the first inner sleeve 104 is attached to the graft material 112 of the main graft 102 by attachment means 142 to define the lumen 126. Similarly, the graft material 136 of the second inner sleeve 106 is attached to the graft material 112 of the main graft 102 by attachment means 142 to define the lumen 132.

[0044] For example, graft materials 134, 136 are portions of a single piece of graft material that are attached (e.g., sutured) to graft material 112 by attachment means 142 along three seams 602, 604, 606 extending between proximal end 108 and distal end 110 of docking graft 100 in directions parallel to longitudinal axes LA1, LA2, and LA3. Thus, cavity 126 is defined by the portion of graft material 112 between seams 602, 604 and the portion of graft material 134 between seams 602, 604. Similarly, cavity 132 is defined by the portion of graft material 112 between seams 604, 606 and the portion of graft material 136 between seams 604, 606.

[0045] Refer to it again Figure 1-4 , the first inner cannula 104 including lumen 126 and the second inner cannula 106 including lumen 132 are positioned within the lumen 120 of the main graft 102. The remaining volume of the lumen 120 of the main graft 102 not occupied by the cannulae 104, 106 is the main docking channel 144, sometimes referred to as the main docking lumen 144. More specifically, the main docking channel 144 is the portion of the lumen 120 of the main graft 102 not occupied by the cannulae 104, 106. In other words, the main docking channel 144 is defined by the inner surface of the graft material 112 and the outer surfaces of the cannulae 104, 106.

[0046] More specifically, lumen 120 of main graft 102 is divided into or formed by lumens 126, 132, and 144. Lumens 126, 132, 144 are parallel to one another and extend the entire length of docking graft 100.

[0047] Thus, the main docking channel 144 extends the entire length of the docking graft 100 from the proximal end 108 to the distal end 110. The main docking channel 144 has a proximal opening 146 at the proximal end 108 that is the area of ​​the proximal opening 116 of the graft material 112 minus the area of ​​the proximal openings 122, 128 of the sleeves 104, 106. Additionally, the main docking channel 144 has a distal opening 148 at the distal end 108 that is the area of ​​the distal opening 118 of the graft material 112 minus the area of ​​the distal openings 124, 130 of the sleeves 104, 106.

[0048] As discussed further below, the main docking channel 144 is a channel for docking a main tube graft therein. Furthermore, the lumens 126, 132 of the inner sleeves 104, 106 are channels for docking a branch stent graft therein and are therefore sometimes referred to as docking channels 126, 132. Generally, the docking graft 100 is a docking device for attaching and securing a tube graft and a branch stent graft in the aorta, as described below.

[0049] Figure 7FIG. 7 is a vascular assembly 700 including a docking graft 100 after deployment according to one embodiment. Figure 7 The thoracic aorta 704 has many arterial branches. The arch AA of the aorta 704 has three major branches extending from it, all of which generally arise from the convex superior surface of the arch AA. The brachiocephalic artery (BCA) originates 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).

[0050] The left common carotid artery (LCC) originates from the arch AA of the aorta 704, just to the left of 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 origin 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).

[0051] 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.

[0052] Aneurysms, dissections, penetrating ulcers, intramural hematomas, and / or transections, commonly referred to as diseased areas of the aorta 704, can occur in the aortic arch AA and peripheral arteries BCA, LCC, and LSA. For example, thoracic aortic aneurysms include aneurysms present in the ascending thoracic aorta, the aortic arch AA, and one or more branch arteries BCA, LCC, and LSA emanating therefrom. Thoracic aortic aneurysms also include aneurysms present in the descending thoracic aorta and branch arteries emanating therefrom. Therefore, as Figure 7 The aorta 704 shown may have a diseased area similar to any of the areas discussed above, which will be bypassed and excluded using the docking graft 100 as discussed below.

[0053] The dock graft 100 is deployed, for example, via a femoral access port into the aorta 704. For example, to deploy the dock graft 100, a guidewire is introduced via the femoral access port, ie, inserted into the femoral artery and directed upward through the abdominal aorta and into the thoracic aorta.

[0054] A delivery system including the docking graft 100 is introduced via a femoral approach and advanced over a guidewire into the ascending aorta 704. The delivery system is positioned at the desired location so that the docking graft 100 is positioned in the ascending aorta near the aortic valve AV. The docking graft 100 is then deployed from the delivery system, for example, by removing a sheath that confines the docking graft 100. In another embodiment, the docking graft 100 is delivered via a supra-aortic approach.

[0055] The main graft 102 is positioned and secured within the aorta 704 such that the distal end 110 is proximal to the brachiocephalic artery (BCA). Thus, blood flows into the proximal opening 116 of the main graft 102, flows through the lumen 120 of the main graft 102 (including through lumens 126, 132), and exits the distal opening 118 of the main graft 102 and into the aorta 704, thereby perfusing the distal region.

[0056] According to this embodiment, the docking graft 100 is deployed such that the sleeves 104, 106 are positioned along the convex superior surface of the arch AA. Figure 7 , for clarity, the docking channels 126, 132, 144 are shown arranged side by side along the convex upper surface of the arch AA. Once deployed, the docking graft 100, including the main graft 102, inner sleeves 104, 106, and main docking channel 144, assumes the shape of the aorta 704 due to the flexible design of the docking graft 100.

[0057] Figure 8 According to one embodiment Figure 7 A cross-sectional view of a vascular assembly 700 at a later stage during deployment of a first bridging stent graft 802 (sometimes referred to as a bridging stent). Figure 8 The bridging stent graft 802 is located within the inner sleeve 104, namely, within the docking channel 126 and the brachiocephalic artery BCA. More specifically, the bridging stent graft 802 is self-expanding (or balloon-expandable) to be anchored within the inner sleeve 104 and the brachiocephalic artery BCA.

[0058] Bridging stent graft 802 comprises graft material 804 and one or more ring stents 806. Graft material 804 comprises any of the graft materials discussed above with respect to graft material 112. Additionally, ring stents 806 are similar or identical to ring stents 114, discussed above.

[0059] In one embodiment, the bridging stent graft 802 is deployed via a supra-aortic portal. For example, to deploy the bridging stent graft 802, a guidewire is introduced through the right subclavian artery RSA and advanced into the distal opening 124 of the inner cannula 104.

[0060] A delivery system containing bridging stent graft 802 is introduced via a supra-aortic portal and advanced over a guidewire into the brachiocephalic artery BCA and inner cannula 104. Bridging stent graft 802 is then deployed from the delivery system, for example, by removing a sheath that confines it.

[0061] In one embodiment, the proximal end 808 of the bridging stent-graft 802 is adjacent to or distal to the proximal opening 122 of the inner sleeve 104. Thus, the bridging stent-graft 802 overlaps the entire length of the docking graft 100, ensuring a good overlap and seal between the bridging stent-graft 802 and the inner sleeve 104. However, in other embodiments, the bridging stent-graft 802 does not overlap the entire length of the docking graft 100, but rather has sufficient overlap to ensure an adequate seal. According to this embodiment, the bridging stent-graft 802 is coaxial with the inner sleeve 104.

[0062] After deployment of the bridging stent-graft 802, blood flow into the inner sheath 104, i.e., the proximal opening 122, is bridged and delivered to the brachiocephalic artery (BCA) through the bridging stent-graft 802. Because the bridging stent-graft 802 is deployed via supra-aortic access, perfusion of the brachiocephalic artery (BCA) is immediate and reliable, thereby minimizing the complexity and associated risks of the procedure.

[0063] Figure 9 According to one embodiment Figure 8 A side plan view of the vascular assembly 700 at a later stage during deployment of a second bridging stent graft 902 (sometimes referred to as a bridging stent). Figure 9 The bridging stent graft 902 is located within the inner sleeve 106, that is, within the docking channel 132, and within the left subclavian artery LSA. More specifically, the bridging stent graft 902 is self-expanding (or balloon-expandable) to be anchored within the inner sleeve 106 and the left subclavian artery LSA.

[0064] Bridging stent graft 902 includes graft material 904 and one or more ring stents 906. Graft material 904 includes any of the graft materials discussed above with respect to graft material 112. Additionally, ring stents 906 are similar or identical to ring stents 114, discussed above.

[0065] In one embodiment, the bridging stent-graft 902 is deployed via a supra-aortic portal. For example, to deploy the bridging stent-graft 902 , a guidewire is introduced through the left subclavian artery (LSA) and advanced into the distal opening 130 of the inner cannula 106 .

[0066] A delivery system containing bridging stent graft 902 is introduced via a supra-aortic portal and advanced over a guidewire into the left subclavian artery LSA and inner sheath 106. Bridging stent graft 902 is then deployed from the delivery system, for example, by removing a sheath that confines it.

[0067] In one embodiment, the proximal end 908 of the bridging stent graft 902 is adjacent to or distal to the proximal opening 128 of the inner sleeve 106. Thus, the bridging stent graft 902 overlaps the entire length of the docking graft 100, ensuring a good overlap and seal between the bridging stent graft 902 and the inner sleeve 106. However, in other embodiments, the bridging stent graft 902 does not overlap the entire length of the docking graft 100, but rather has sufficient overlap to ensure an adequate seal. According to this embodiment, the bridging stent graft 902 is coaxial with the inner sleeve 106.

[0068] After deployment of the bridging stent-graft 902, blood flow into the inner sheath 106, i.e., the proximal opening 128, is bridged and delivered to the left subclavian artery LSA through the bridging stent-graft 902. Because the bridging stent-graft 902 is deployed via supra-aortic access, perfusion of the left subclavian artery LSA is immediate and reliable, thereby minimizing the complexity and associated risks of the procedure.

[0069] Figure 10 According to one embodiment Figure 9 A cross-sectional view of the vascular assembly 700 at the final stage during deployment of the tube graft 1002. Figure 10 , the tube graft 1002 is deployed into and attached to the main graft 102 and the aorta 704. More specifically, the tube graft 1002 is deployed into the main docking channel 144 and the main graft 102.

[0070] Tube graft 1002 includes graft material 1004 and one or more annular stents 1006. Graft material 1004 includes any of the graft materials discussed above with respect to graft material 112. Additionally, annular stents 1006 are similar or identical to annular stents 114, discussed above.

[0071] The tube graft 1002 is deployed, for example, via femoral access into the main graft 102 and aorta 704. For example, to deploy the tube graft 1002, a guidewire is introduced via femoral access, i.e., inserted into the femoral artery and passed upward through the abdominal aorta into the distal opening 148 of the main docking passage 144, and more generally into the distal opening 118 of the main graft 102. A delivery system including the tube graft 1002 is introduced via femoral access and advanced into the main docking passage 144, and more generally over the guidewire into the lumen 120 of the main graft 102. The tube graft 1002 is then deployed from the delivery system, for example, by removing a sheath that constrains the tube graft 1002.

[0072] In one embodiment, the proximal end 1008 of the tube graft 1002 is adjacent to or distal to the proximal opening 146 of the main docking passage 144 and generally adjacent to or distal to the proximal opening 116 of the main graft 102. Thus, the tube graft 1002 overlaps the entire length of the dock graft 100, ensuring a good overlap and seal between the tube graft 1002 and the main graft 102, the first inner cannula 104, and the second inner cannula 106. However, in other embodiments, the tube graft 1002 does not overlap the entire length of the dock graft 100, but rather has sufficient overlap to ensure an adequate seal. According to this embodiment, the tube graft 1002 is coaxial with the main docking passage 144.

[0073] In one embodiment, the inner sleeves 104, 106 are configured to exert a radial force higher than the radial force of the tube graft 1002. As used herein, "radial force" encompasses radial force exerted during expansion / deployment, as well as chronic radial force continuously applied after implantation, such that the architecture has a predetermined compliance or resistance to the surrounding native anatomy (e.g., aorta 704) as it expands and contracts during the cardiac cycle. The radial force of the tube graft 1002 is configured to be lower than the radial force of the inner sleeves 104, 106 to avoid collapse of the inner sleeves 104, 106 when the tube graft 1002 is deployed against and adjacent thereto and thereby maintain perfusion of the inner sleeves 104, 106.

[0074] To configure the inner sleeves 104, 106 and the tube graft 1002 with different relative radial forces, the annular stents 138, 140 of the inner sleeves 104, 106 are constructed with relatively thicker and / or shorter material segments than the annular stent 1006 of the tube graft 1002. The shorter and / or thicker annular stents 138, 140 have less flexibility but a greater radial force to ensure that the annular stent 1006 of the tube graft 1002 does not collapse the lumens 126, 132 of the inner sleeves 104, 106. In other embodiments, other variations or modifications of the annular stents 138, 140, 1006 may be used to achieve the relative radial forces.

[0075] In another embodiment, bridging stent-grafts 802, 902 are configured to exert a higher radial force than that of tube graft 1002. For example, annular stents 806, 906 of bridging stent-grafts 802, 902 are comprised of relatively thicker and / or shorter segments of material than annular stents 1006 of tube graft 1002. Thus, bridging stent-grafts 802, 902 prevent inner sleeves 104, 106 from collapsing when tube graft 1002 is deployed against and adjacent thereto, thereby maintaining perfusion of inner sleeves 104, 106, including bridging stent-grafts 802, 902 therein.

[0076] When the tube graft 1002 is deployed, blood flow into the proximal opening 146 of the main docking channel 144 is bridged and passed through the tube graft 1002 into the aorta 704. In this way, any overlapping diseased areas of the aorta 704 are excluded.

[0077] Typically, grafts 802, 902, 1002 are deployed in parallel within the dock graft 100. The dock graft 100 forms a base or anchoring device for attaching the grafts 802, 902, 1002 to the aorta 704. After subselecting each portal, the grafts 802, 902 are deployed through a supra-aortic approach. The grafts 802, 902, 1002 extend distally and in parallel from the dock graft 100. Although various features may be described as parallel, according to the present disclosure, these features may not be completely parallel due to being deformed by and assuming the shape of the aorta 704.

[0078] According to this embodiment, the tube graft 1002 overlaps, excludes, and thus occludes the left common carotid artery (LCC). According to this embodiment, the bypass 1010, i.e., the bypass graft, provides perfusion to the left common carotid artery (LCC). Illustratively, the bypass 1010 provides perfusion to the left common carotid artery (LCC) from the left subclavian artery (LSA).

[0079] The shunt 1010 is surgically inserted during the same deployment procedure as the dock graft 100, grafts 802, 902, and tube graft 1002. However, in another embodiment, the shunt 1010 is surgically inserted prior to the deployment of the dock graft 100, grafts 802, 902, and tube graft 1002, e.g., to simplify the procedure.

[0080] Figure 11 For a later stage during deployment of the bridging stent graft 902 according to another embodiment Figure 8 Side plan view of vascular assembly 700. Figure 11 The vascular assembly 700 is similar to Figure 10 vascular assembly 700, and only the significant differences are discussed below.

[0081] Now refer to Figure 11 , the bridging stent graft 902 is located within the inner sleeve 106, that is, within the docking channel 132, and within the left common carotid artery LCC (in contrast, Figure 10 In FIG. 1 , bridging stent-graft 902 is positioned within the left subclavian artery (LSA). More specifically, bridging stent-graft 902 is self-expanding (or balloon-expandable) to anchor within inner sheath 106 and the left common carotid artery (LCC).

[0082] In one embodiment, the bridging stent graft 902 is deployed via a supra-aortic portal. For example, to deploy the bridging stent graft 902 , a guidewire is introduced through the left common carotid artery (LCC) and advanced into the distal opening 130 of the inner cannula 106 .

[0083] A delivery system containing bridging stent graft 902 is introduced via a supra-aortic portal and advanced over a guidewire into the left common carotid artery LCC and inner sheath 106. Bridging stent graft 902 is then deployed from the delivery system, for example, by removing a sheath that confines it.

[0084] After deployment of the bridging stent-graft 902, blood flowing into the inner sheath 106, i.e., the proximal opening 128, is bridged and passed into the left common carotid artery LCC through the bridging stent-graft 902. When the bridging stent-graft 902 is deployed via the supra-aortic approach, perfusion of the left common carotid artery LCC is immediate and reliable, thereby minimizing the complexity and associated risks of the procedure.

[0085] Tube graft 1002 is deployed into main graft 102 and aorta 704 and attached thereto as described above. Tube graft 1002 overlaps, excludes, and thereby occludes the left subclavian artery (LSA). According to this embodiment, bypass 1010 provides perfusion to the left subclavian artery (LSA). Illustratively, bypass 1010 provides perfusion to the left subclavian artery (LSA) from the left common carotid artery (LCC).

[0086] Figure 12 is a later stage during deployment of a bridging bifurcated graft 1202 (sometimes referred to as first bridging stent graft 1202) according to one embodiment. Figure 7 Now referring to the cross-sectional view of the blood vessel assembly 700. Figure 12 , a bifurcated graft 1202 includes a main graft 1204 that bifurcates into a first branch graft 1206 and a second branch graft 1208. The first branch graft 1206 is longer than the second branch graft 1208 and is sometimes referred to as the contralateral gate.

[0087] The main graft 1204 is positioned within the inner cannula 104, i.e., within the docking channel 126, and the first branch graft 1206 is positioned along the brachiocephalic artery (BCA). More specifically, the main graft 1204 is self-expanding (or balloon-expandable) to anchor within the inner cannula 104, and the first branch graft 1206 is self-expanding (or balloon-expandable) to anchor within the brachiocephalic artery (BCA). The distal opening 1210 of the second branch graft 1208 is proximal to the left common carotid artery (LCC).

[0088] The bifurcated graft 1202 comprises a graft material 1212 and one or more annular stents 1214. The graft material 1212 comprises any of the graft materials discussed above with respect to the graft material 112. Additionally, the annular stents 1214 are similar or identical to the annular stents 114 discussed above.

[0089] In one embodiment, the bifurcated graft 1202 is deployed via a supra-aortic approach after subselection of the portal. For example, to deploy the bifurcated graft 1202 , a guidewire is introduced through the right subclavian artery RSA and advanced into the distal opening 124 of the inner cannula 104 .

[0090] A delivery system containing the bifurcated graft 1202 is introduced via a supra-aortic access port and advanced over a guidewire into the brachiocephalic artery BCA and inner cannula 104. The bifurcated graft 1202 is then deployed from the delivery system, for example, by removing a sheath constraining the bifurcated graft 1202.

[0091] In one embodiment, the proximal end 1216 of the bifurcated graft 1202 is adjacent to or distal to the proximal opening 122 of the inner cannula 104. Thus, the bifurcated graft 1202 overlaps the entire length of the butt graft 100, ensuring a good overlap and seal between the bifurcated graft 1202 and the inner cannula 104. However, in other embodiments, the bifurcated graft 1202 does not overlap the entire length of the butt graft 100, but rather has enough overlap to ensure an adequate seal.

[0092] When the bifurcated graft 1202 is deployed, blood flow into the inner cannula 104, i.e., the proximal opening 122, is bridged and passed through the bifurcated graft 1202, i.e., into the brachiocephalic artery (BCA) through the first branch graft 1204. Because the bifurcated graft 1202 is deployed via supra-aortic access, perfusion of the brachiocephalic artery (BCA) is immediate and reliable, thereby minimizing the complexity and associated risks of the procedure.

[0093] Figure 13 For a later stage during deployment of the bridging stent graft 1302 according to another embodiment Figure 12 A side plan view of the vascular assembly 700 is now shown. Figure 13The bridging stent-graft 1302 is located within the second branch graft 1208 and the left common carotid artery LCC. More specifically, the bridging stent-graft 1302 is self-expanding (or balloon-expandable) to be anchored within the second branch graft 1208 and the left common carotid artery LCC.

[0094] In one embodiment, bridging stent-graft 1302 is deployed via a supra-aortic portal. For example, to deploy bridging stent-graft 1302, a guidewire is introduced through the left common carotid artery (LCC) and advanced into the distal opening 1210 of second branch graft 1208.

[0095] A delivery system containing bridging stent graft 1302 is introduced via a supra-aortic portal and advanced over a guidewire into the left common carotid artery LCC and second branch graft 1208. Bridging stent graft 1302 is then deployed from the delivery system, for example, by removing a sheath that confines it.

[0096] After deployment of bridging stent-graft 1302, blood flow entering the second branch graft 1208 is bridged and delivered to the left common carotid artery LCC through bridging stent-graft 1302. When bridging stent-graft 1302 is deployed via supra-aortic access, perfusion of the left common carotid artery LCC is immediate and reliable, thereby minimizing the complexity and associated risks of the procedure.

[0097] Figure 14 For later stages during deployment of the bridging stent graft 902 and tube graft 1002 according to one embodiment Figure 13 A cross-sectional view of the vascular assembly 700 is provided. The bridging stent graft 902 is similar to the one described above with respect to Figure 9 The manner discussed above in which the tube graft 1002 is located within the inner cannula 106, i.e., within the docking passage 132, and within the left subclavian artery LSA, will not be repeated here for the sake of simplicity. Figure 10 The discussed arrangements for deployment into the main graft 102 and aorta 704 are not repeated here for the sake of brevity.

[0098] 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 instance, certain actions or events in 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 to perform these techniques). Furthermore, 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 techniques 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 docking graft comprising: a main graft defining a main cavity; a first lumen within the main lumen, the first lumen configured to receive a first bridging stent-graft therein, the first lumen being defined by a first inner sleeve; a second lumen within the main lumen, the second lumen configured to receive a second bridging stent-graft therein, the second lumen being defined by a second inner sleeve; and a main docking lumen within the main cavity, the main docking lumen configured to receive a tube graft therein, the first lumen, the second lumen, and the main docking lumen being parallel to one another and extending the entire length of the docking graft from a proximal end of the docking graft to a distal end of the docking graft when the docking graft is in a relaxed configuration; wherein the main docking cavity has a proximal opening at the proximal end of the docking graft, the proximal opening being defined by an inner surface of the main graft and outer surfaces of the first inner sleeve and the second inner sleeve; and The main docking cavity has a distal opening at the distal end of the docking graft, and the distal opening is defined by an inner surface of the main graft and outer surfaces of the first inner sleeve and the second inner sleeve. 2 . The vascular assembly of claim 1 , wherein the primary docking lumen is defined by the main graft, the first inner sleeve, and the second inner sleeve.

3. The vascular assembly of claim 1, wherein the main lumen is comprised of the first lumen, the second lumen, and the main docking lumen.

4. The vascular assembly of claim 1 , further comprising: the first bridging stent-graft within the first lumen; the second bridging stent-graft within the second lumen; and The tube graft within the primary docking lumen.

5. The vascular assembly of claim 4, wherein the first bridging stent-graft, the second bridging stent-graft, and the tube graft are parallel to each other within the docking graft and extend distally from the docking graft.

6. The vascular assembly of claim 4, wherein the first bridging stent graft comprises: primary graft; first branch graft; and A second branch graft, wherein the main graft is bifurcated into a first branch graft and a second branch graft, and the assembly further comprises: A bridging stent graft in the second branch graft.

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