Multi-lumen stent-grafts and related surgical methods

Abstract

A multi-lumen stent graft including a graft portion and a stent frame. The stent graft includes multiple through-channels formed from the graft portion. The graft portion can include a PTFE material, and the through-channels can be formed from fused portions of the graft portion. The stent graft can be used in prostheses that connect multiple vascular branches, such as for repair of aortic aneurysms or other blood vessels in the body.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application is a continuation of U.S. patent application Ser. No. 17 / 497,199, filed October 8, 2021, entitled "Multi-Lumen Stent-Grafts and Related Surgical Methods," which claims the benefit of U.S. patent application Ser. No. 63 / 203,046, filed July 6, 2021, the entireties of which are incorporated herein by reference. [Technical field]

[0002] FIELD OF THE DISCLOSURE This disclosure relates generally to stent grafts and related methods and techniques for implantation within the human or animal body to repair damaged blood vessels, ducts or other passageways. [Background technology]

[0003] Blood vessels and ducts in the human or animal body, such as blood vessels, can occasionally weaken or grow in diameter and eventually rupture. An example of this is an aortic aneurysm, which involves an abnormal dilation of the wall of the aorta. Over time and exposed to the pressure of hemodynamic forces, the aneurysm can rupture, causing fatal bleeding. One surgical intervention for aneurysms or other weakened or ruptured blood vessels involves the use of an intraluminal prosthesis, such as a graft, to provide some or all of the functionality of the original healthy blood vessel, particularly to reduce hemodynamic forces on the aneurysm. U.S. Patent Publication No. 2014 / 0371836 provides examples of devices and surgical techniques for bridging aneurysms in the thoracic aorta. Summary of the Invention

[0004] According to a first aspect, a multi-lumen expandable stent graft includes a single tube graft sleeve of polymeric material forming first, second and third parallel flow channels between a first open end and a second open end. A self-expanding wire stent is mounted coaxially over the graft sleeve and secured to said graft sleeve at the first and second open ends. The first flow channel is formed by a first straight connecting segment of the polymeric material channel. The first straight connecting segment is aligned parallel to a longitudinal axis of the stent graft and includes inlet and outlet ports spaced inwardly from the first and second open ends of the graft sleeve. The second flow channel is formed by a second straight connecting segment of the polymeric material channel. The second straight connecting segment is aligned parallel to a longitudinal axis of the stent graft and includes inlet and outlet ports spaced inwardly from the first and second open ends of the graft sleeve. The third flow channel is formed by a third straight connecting segment of the polymeric material channel. The third straight connecting segment includes inlet and outlet ports aligned parallel to the longitudinal axis of the stent graft and spaced inwardly from the first and second open ends of the graft sleeve. The polymeric material of the graft sleeve is or includes polytetrafluoroethylene (PTFE), and the first, second, and third straight connecting segments include fused portions of PTFE material. The total perimeter of each flow channel and any connecting segments is approximately equal to the perimeter of a single tube of polymeric material.

[0005] According to a second aspect, a multi-lumen expandable stent graft includes a graft sleeve with a polymeric material forming first, second and third flow channels between a first open end and a second open end. A self-expanding wire stent is coaxially mounted over the graft sleeve and secured to said graft sleeve at the first and second open ends. The first flow channel is formed by a first straight connecting segment of the polymeric material channel. The first straight connecting segment is aligned parallel to a longitudinal axis of the stent graft and includes inlet and outlet ports spaced inwardly from the first and second open ends of the graft sleeve. The second flow channel is formed by a second straight connecting segment of the polymeric material channel. The second straight connecting segment is aligned parallel to a longitudinal axis of the stent graft and includes inlet and outlet ports spaced inwardly from the first and second open ends of the graft sleeve. The third flow channel is formed by a third straight connecting segment of the polymeric material channel. The third straight connecting segment is aligned parallel to the longitudinal axis of the stent graft and includes inlet and outlet ports spaced inwardly from the first and second open ends of the graft sleeve.

[0006] According to another aspect, the first, second, and third channels are parallel. According to another aspect, the first, second, and third channels are not supported by a self-expanding wire stent. According to another aspect, the first and second open ends each include a cylindrical wall supported by a self-expanding wire stent. According to another aspect, each end of the first, second, and third straight connecting segments is spaced inwardly from the first and second open ends. According to another aspect, the first and second open ends include a folded portion of polymeric material. According to another aspect, the first and second open ends include an additional layer of polymeric material encapsulating the first and second ends of the stent portion. According to another aspect, the graft sleeve comprises a single tube of polymeric material, and the total circumference of each flow channel is equal to the circumference of the single tube of polymeric material. According to another aspect, the polymeric material of the graft sleeve comprises polytetrafluoroethylene (PTFE), and the first, second, and third straight connecting segments comprise fused portions of PTFE material. According to another aspect, the fused portion of the PTFE material is formed by melting the PTFE material above its melting temperature. According to another aspect, the fused portion of the PTFE material is formed by ultrasonic welding. According to another aspect, the fused portion of the first straight connection segment includes an intermediate layer of PTFE material. According to another aspect, the first open end has a length that is 2 to 5 times greater than the length of the second open end. According to another aspect, the channel lengths of the first, second, and third channels are 50% to 90% of a hub length that extends from an upper rim of the first open end to a lower rim of the second open end. According to another aspect, the channel lengths of the first, second, and third channels are 75% to 90% of a hub length that extends from an upper rim of the first open end to a lower rim of the second open end. According to another aspect, a first diameter of the first flow channel is within 10%-40% of a sleeve diameter of the first and second open ends, a second diameter of the second flow channel is within 10%-40% of the sleeve diameter, and a third diameter of the third flow channel is within 50%-80% of the sleeve diameter.According to another aspect, a first diameter of the first flow channel is within 5%-25% of a sleeve diameter of the first and second open ends, a second diameter of the second flow channel is within 5%-25% of the sleeve diameter, a third diameter of the third flow channel is within 5%-25% of the sleeve diameter, and a fourth diameter of the fourth flow channel is within 50%-75% of the sleeve diameter.

[0007] According to a third aspect, an expandable stent graft includes a graft sleeve having a polytetrafluoroethylene (PTFE) material forming a primary fluid flow channel between a first open end and a second open end of the graft sleeve and including an outer surface and an inner surface. A first inner channel and a second inner channel are formed in the graft sleeve, each inner channel including an inlet port and an outlet port spaced inwardly from the first and second open ends of the graft sleeve. The first and second inner flow channels are separated by a straight connecting segment aligned along a longitudinal axis of the graft sleeve. The straight connecting segment is formed from a fused portion of the inner surface of the PTFE material of the graft sleeve. A self-expanding wire stent is coaxially mounted over the graft sleeve and secured to the graft sleeve at the first and second open ends.

[0008] According to another aspect, the first and second internal flow channels are not supported by a self-expanding wire stent. According to another aspect, the first and second open ends each include a cylindrical wall supported by a self-expanding wire stent. The inlet and outlet ports are spaced inwardly from the respective cylindrical walls. According to another aspect, the first and second ends of the straight connecting segments are spaced inwardly from the respective cylindrical walls of the graft sleeve. According to another aspect, the cylindrical walls include a folded portion of PTFE material. According to another aspect, the graft sleeve comprises a single tube of PTFE material, and the total perimeter of each flow channel is equal to the perimeter of the single tube of polymeric material. According to another aspect, the fused portion of the inner surface of the PTFE material is formed by melting the PTFE material above its melting temperature. According to another aspect, the fused portion of the inner surface of the PTFE material is formed by ultrasonic welding. According to another aspect, the first and second channels each comprise a cylindrical wall. According to another aspect, the channel length of the first and second channels is between 50% and 90% of the hub length extending from the upper rim of the first open end to the lower rim of the second open end. According to another aspect, the channel length of the first and second channels is between 75% and 90% of the hub length extending from the upper rim of the first open end to the lower rim of the second open end. According to another aspect, the first diameter of the first flow channel is within 20% and 50% of the sleeve diameter of the first and second open ends and the second diameter of the second flow channel is within 50% and 80% of the sleeve diameter.

[0009] According to a fourth aspect, a method of manufacturing an expandable stent graft includes positioning a graft sleeve comprising a polytetrafluoroethylene (PTFE) material over a body of a mandrel. The mandrel includes a central portion including a first channel mandrel and a second channel mandrel. The longitudinal axes of the first and second channel mandrels are aligned with a longitudinal axis of the mandrel. A first portion of a first side of the graft sleeve is inserted between the first channel mandrel and the second channel mandrel and forced into contact with a second portion of a second side of the graft sleeve. The first and second portions of the graft sleeve are fused to form a straight connecting segment aligned along the longitudinal axis of the mandrel. The straight connecting segment divides the central portion of the graft sleeve into a first internal channel and a second internal channel formed in the graft sleeve. The graft sleeve can be removed from the mandrel.

[0010] According to a further aspect, the self-expanding wire stent is coaxially mounted over the graft sleeve while still on the mandrel. The self-expanding wire stent is secured to the first and second open ends of the graft sleeve. According to another aspect, the ends of the graft sleeve are folded over the ends of the self-expanding wire stent. According to another aspect, the ends of the self-expanding wire stent are encapsulated between additional PTFE material and the graft sleeve. According to another aspect, the straight connection segment is formed by melting the PTFE material above its melting temperature. According to another aspect, the straight connection segment is formed by ultrasonic welding. According to another aspect, the first and second channel mandrels are removable from the body of the mandrel. According to another aspect, the first and second channel mandrels each comprise a cylindrical member having a diameter corresponding to the diameter of the respective first and second channels. According to another aspect, an intermediate layer of PTFE material is included between a first portion of the first side of the graft sleeve and a second portion of the second side of the graft sleeve to form the straight connection segment.

[0011] According to a fifth aspect, a method of surgically implanting a prosthesis for treatment of a branched vessel includes positioning a first stent graft hub having a primary flow channel. The first flow channel and a second flow channel are proximate to a treatment location. A hub guidewire is inserted into the branched vessel. A catheter is advanced along the hub guidewire. The first stent graft hub is deployed using the catheter. A treatment location along the branched vessel is bridged with a primary graft tube, including advancing a primary catheter within the primary flow channel. A first end of the primary graft tube is deployed within the primary flow channel. A second end of the primary graft tube is deployed within the branched vessel with the primary catheter. The treatment location is bridged by the first graft tube between the first stent graft hub and a first branch of the branched vessel. This includes inserting a first guidewire into a first flow channel of a first stent graft hub through a first branch of a branched vessel, advancing a first catheter along the first guidewire, deploying a first end of a first graft tube in the first flow channel, and deploying a second end of the first graft tube in the first branch with the first catheter. The treatment location is bridged between the first stent graft hub and a second branch of the branched vessel by a second graft tube. This includes inserting a second guidewire into a second flow channel of a second stent graft hub through a second branch of the branched vessel, advancing a second catheter along the second guidewire, and deploying a first end of a second graft tube in the second flow channel and a second end of the second graft tube in the second branch with the second catheter.

[0012] According to another aspect, the method further includes bridging a treatment location between the first stent graft hub and a third branch of the branched vessel with a third graft tube, inserting a third guidewire into a third flow channel of the first stent graft hub through the third branch of the branched vessel, advancing a third catheter along the third guidewire, and deploying a first end of the third graft tube in the third flow channel and a second end of the third graft tube in the third branch. According to another aspect, the method further includes positioning a second stent graft hub having a primary flow channel and a first flow channel on an opposite side of the treatment location from the first stent graft hub. The primary graft tube bridges a treatment location along the branched vessel by deploying a second end of the primary graft tube in the primary flow channel of the second stent graft hub. According to another aspect, the method further includes bridging a treatment location between the second stent graft hub and the third branch of the branched vessel with a third graft tube by inserting a third guidewire into a first flow channel of the second stent graft hub through the third branch of the branched vessel and advancing a third catheter along the third guidewire to deploy a first end of the third graft tube within the first flow channel of the second stent graft hub and a second end of the third graft tube within the third branch.

[0013] According to a sixth aspect, a multi-lumen expandable stent graft has a graft sleeve formed from a single tube of polymeric material having a sleeve diameter. The first open end includes a first cylindrical wall having an upper rim. The second open end includes a second cylindrical wall having a lower rim. The first open end is spaced apart from the second open end along a longitudinal axis. A hub length extends from the upper rim of the first open end to the lower rim of the second open end. A plurality of parallel flow channels extend between the first open end and the second open end and define a channel length therebetween. The channel length is between 50% and 90% of the hub length. The first flow channel is formed by a first straight connecting segment of the polymeric material channel and includes inlet and outlet ports in communication with respective first and second open ends of the graft sleeve. The first straight connecting segment is aligned parallel to a longitudinal axis of the stent graft. The first straight connecting segment includes a first width. A second flow channel is formed by a second straight connecting segment of the polymeric material channel and includes inlet and outlet ports communicating with the first and second open ends of each of the graft sleeves. The second straight connecting segment is aligned parallel to the longitudinal axis of the stent graft. The second straight connecting segment includes a second width. A third flow channel is formed by a third straight connecting segment of the polymeric material channel and includes inlet and outlet ports communicating with the first and second open ends of each of the graft sleeves. The third straight connecting segment is aligned parallel to the longitudinal axis of the stent graft. The third straight connecting segment has a third width. A fourth flow channel is formed by the first, second, and third straight connecting segments of the polymeric material channel and includes inlet and outlet ports communicating with the first and second open ends of each of the graft sleeves. A self-expanding wire stent is coaxially mounted over the graft sleeve and secured to said graft sleeve at a first cylindrical wall at the first open end and a second cylindrical wall at the second open end. The polymeric material of the graft sleeve comprises polytetrafluoroethylene (PTFE), and the first, second, and third straight connecting segments comprise fused portions of the PTFE material.The sum of 1) the perimeter of each of the first, second, third, and fourth flow channels plus 2) twice the sum of the first, second, and third widths of each of the first, second, and third straight connecting segments is equal to the perimeter of a single tube of polymeric material. The first diameter of the first flow channel is within 5%-25% of the sleeve diameter, the second diameter of the second flow channel is within 5%-25% of the sleeve diameter, the third diameter of the third flow channel is within 5%-25% of the sleeve diameter, and the fourth diameter of the fourth flow channel is within 50%-75% of the sleeve diameter.

[0014] The foregoing summary is illustrative only and is not intended to be limiting. Other aspects, features, and advantages of the systems, devices, and methods described herein, and / or other subject matter, will become apparent in the teachings set forth below. The summary is provided to introduce a selection of some of the concepts of the present disclosure. The summary is not intended to identify key or essential features of the subject matter described herein. [Brief description of the drawings]

[0015] Various examples are illustrated in the accompanying drawings for purposes of illustration and should not be construed as limiting the scope of the examples in any way. Various features of different disclosed examples can be combined to form further examples that are part of this disclosure.

[0016] [Figure 1A] 1 shows a perspective view of a stent graft including a stent portion and a graft portion.

[0017] [Figure 1B] FIG. 2 shows a perspective end view of the stent graft.

[0018] [Figure 1C] A first side view of the stent graft is shown.

[0019] [Figure 1D] A second side view of the stent graft is shown.

[0020] [Figure 1E] A first end view of the stent graft is shown.

[0021] [Figure 1F] A second end view of the stent graft is shown.

[0022] [Figure 2A] 2A shows a cross-sectional view taken along line 2A-2A of FIG. 1C.

[0023] [Figure 2B] 2B shows a cross-sectional view taken along line 2B-2B of FIG. 1C.

[0024] [Figure 2C] A cross-sectional view is shown along line 2C-2C of FIG. 1F.

[0025] [Figure 3A] FIG. 2 shows a side view of the stent portion of the stent graft.

[0026] [Figure 3B] 1 shows an end view of the stent portion of the stent graft.

[0027] [Figure 4A] 1 illustrates an optional configuration of multiple flow channels including a main channel and three branch channels within the graft portion of a stent graft.

[0028] [Figure 4B] FIG. 13 shows an optional configuration of multiple flow channels including a main channel and two branch channels within the graft portion of a stent graft.

[0029] [Figure 4C] 13A-13C show optional configurations of multiple flow channels including a main channel and one branch channel within the graft portion of a stent graft.

[0030] [Figure 4D] FIG. 13 illustrates an optional configuration of multiple flow channels including two main channels of equal diameter within the graft portion of the stent graft.

[0031] [Figure 4E] FIG. 4B shows a side view of the graft portion of FIG. 4A.

[0032] [Figure 4F] FIG. 4C shows a side view of the graft portion of FIG. 4B.

[0033] [Figure 4G] FIG. 4D shows a side view of the graft portion of FIG. 4C.

[0034] [Figure 4H] FIG. 4E shows a side view of the graft portion of FIG. 4D.

[0035] [Diagram 5] 1 shows a front perspective view of another example of a stent graft.

[0036] [Figure 6] FIG. 6 shows a rear perspective view of the stent graft of FIG. 5.

[0037] [Figure 7] FIG. 1 shows an exploded view of a mandrel assembly used in the assembly and manufacture of the stent graft.

[0038] [Figure 8] FIG. 2 shows a perspective view of an end cap of the mandrel assembly.

[0039] [Figure 9] 1 shows the assembly of tubular graft sections over a mandrel.

[0040] [Figure 10]13 illustrates the formation of individual flow channels in the stent portion of the stent graft formed by melting portions of the material of the graft portion between adjacent channel mandrels in the mandrel assembly.

[0041] [Figure 11] 11 shows a cross-sectional view taken along line 11-11 of FIG.

[0042] [Figure 12] 1 shows the alignment of the stent and graft portions.

[0043] [Figure 13] 13 illustrates folding of the graft portion over the open end of the stent portion assembled over the graft portion.

[0044] [Figure 14] The completed stent graft is shown.

[0045] [Figure 15] 1 shows the insertion of a catheter into the aorta to bridge the aortic aneurysm.

[0046] [Figure 16] 1 shows the deployment of the stent graft hub from the catheter within the aorta.

[0047] [Figure 17] 1 shows the insertion of a first connecting stent graft from a first branch artery into a channel of the stent graft hub.

[0048] [Figure 18] 13 shows the deployment of a first connected stent graft within a channel of the stent graft hub.

[0049] [Figure 19] 1 shows the deployment of a prosthesis within the aorta to bridge an aortic aneurysm including multiple connected stent grafts joined within a stent graft hub.

[0050] [Figure 20] 1 shows another prosthesis.

[0051] [Figure 21] 1 shows a prosthesis integrated with a heart valve.

[0052] [Figure 22] 1 shows another prosthesis including two stent grafts for bridging an aortic aneurysm.

[0053] [Diagram 23] 23 shows the prosthesis of FIG. 22 further showing a bridge-connected stent graft.

[0054] [Figure 24A] 13 shows a front view of another stent graft including an open end of one extended length. [Figure 24B] FIG. 13 shows a side view of another stent graft including an open end of one extended length.

[0055] [Figure 25A] 25 illustrates the deployment of a prosthesis within the aorta to bridge an aortic aneurysm including multiple connected stent grafts coupled within the stent graft hub of FIG. 24. [Figure 25B] 25 illustrates the deployment of a prosthesis within the aorta to bridge an aortic aneurysm including multiple connected stent grafts coupled within the stent graft hub of FIG. 24. [Figure 25C] 25 illustrates the deployment of a prosthesis within the aorta to bridge an aortic aneurysm including multiple connected stent grafts coupled within the stent graft hub of FIG. 24.

[0056] [Figure 26] 1 shows a perspective view of another stent graft formed from woven Dacron.

[0057] [Figure 27]27 shows a top view of the stent graft of FIG. 26.

[0058] [Figure 28] FIG. 27 shows a perspective view of a further channel for the stent graft of FIG. 26.

[0059] [Figure 29] 27 shows a further channel assembled with the stent graft of FIG. 26; DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0060] Various features and advantages of the systems, devices, and methods of the technology described herein will become more fully apparent from the following description of illustrated examples. These examples are intended to illustrate the principles of the disclosure, and the disclosure should not be limited to only the illustrated examples. Features of the illustrated examples can be modified, combined, removed, and / or substituted as would be apparent to one skilled in the art in light of the principles disclosed herein.

[0061] Blood vessels may occasionally develop aneurysms, which may rupture and cause fatal hemorrhage. It is therefore common practice to bridge damaged vessel segments, such as aneurysms, using a sufficiently long graft that is anchored within the vessel. This bridge may have the effect of reducing hemodynamic forces on the vessel. Depending on the location of the aneurysm, implantation of a bridge graft may be relatively easy or difficult. Aneurysms occurring within the aortic arch have proven particularly difficult to address for a variety of reasons. One common reason is the great number of variations in the arterial branching patterns of the aortic arch among people. The aortic arch includes the ascending and descending aorta, and typically includes three major arterial branches located in close succession: the brachiocephalic artery (which leads to the right subclavian artery and right common carotid artery), the left common carotid artery, and the left subclavian artery. While this arterial branching pattern is the most common, the spacing and arrangement between the three branches varies from person to person. Other arterial branching patterns are also quite common. That is, the left carotid artery may originate from the brachiocephalic trunk rather than the aortic arch; the left carotid artery may originate from the aortic arch in the same location as the brachiocephalic trunk; the left carotid artery and left subclavian artery may branch off from a common trunk connected to the aorta, etc.

[0062] Due to variations in arterial branching patterns and the relative inaccessibility of the aortic arch, conventional surgical techniques and devices for addressing aneurysms have not provided satisfactory results. Using conventional techniques, a person's arterial branching patterns generally require the creation of custom grafts or a large inventory of fenestrated prostheses. For example, fenestrated grafts require placement of fenestrations to align with each patient's branch vessels. During surgery, each branch needs to be connected to the main stent graft using a connecting graft. However, when the stent graft is deployed, the fenestrations may become misaligned or misaligned relative to the branch vessels. It may also be difficult to deploy guidewires and catheters from the stent graft into the branch vessels to allow for correct positioning of the connecting graft. Also, if the fenestrations are misaligned from the branch vessels, the connecting graft may kink to such an extent that blood flow does not occur through it.

[0063] Thus, the present disclosure includes improved stent graft hubs and prostheses, improved manufacturing processes, and improved surgical techniques that address current deficiencies and provide improved medical outcomes for the aortic arch in other types of surgery.

[0064] 1A-1F show an example of a multi-lumen stent graft 130 including a graft portion 150 and a stent portion 190. The stent portion 190 may comprise a shape memory alloy, such as a superelastic Nitinol or similar material. Desirably, the graft portion 150 may be made from a sheet of polytetrafluoroethylene (PTFE). The graft portion 150 may alternatively be made from Dacron, polyester, and / or other synthetic materials known to those skilled in the art. Optionally, the material of the graft portion 150 may be generally inextensible.

[0065] The stent graft 130 may include a first open end 131 and a second open end 132 opposite the first open end 131. The first end 131 may have a circular shape, but this is not required. The second end 132 may have the same shape as the first end 131, but this is not required. The stent graft 130 may have a diameter W. The diameter W may be uniform from the first end 131 to the second end 132. In other embodiments, the first and second ends 131, 132 may have different diameters. The diameter W may be between about 10 mm and 50 mm, depending on the application. In one example, the first end 131 may have a diameter equal to about 25 mm. The second end 132 may have the same diameter or a different diameter than the first end 131. The stent graft 130 may have a hub length L from the first end 131 to the second end 132. The hub length L can extend from an upper rim at the first end 131 to a lower rim at the second end 132. The hub length L can be between about 1 cm and 15 cm, depending on the application.

[0066] The first end 131 can include a cylindrical wall 133. The cylindrical wall 133 can include one or more ends of the stent portion 190 and / or one or more portions of the graft portion 150. The graft portion 150 can be attached along the inside and / or outside of the cylindrical wall 133. The cylindrical wall 133 can include one or more folded portions of the graft portion 150. The graft portion 150 can be attached to itself (e.g., via adhesives, suturing, fusing, or other techniques) through an opening in the stent portion 190. The cylindrical wall 133 can be supported by the stent portion 190. The cylindrical walls 133, 135 can have lengths 131a, 132a of about 1 mm to 80 mm, depending on the application. The cross section shown in FIG. 2B along line 2B-2B of FIG. 2A extends through the cylindrical wall 133 and shows the inner circumference of the graft portion 150. The inner periphery of cylindrical wall 133 may have a circular shape having a diameter W. Similarly, second end 132 may include a cylindrical wall 135 having the same structure as cylindrical wall 133, although this is not required. Cylindrical walls 133 and / or 135 may be oriented parallel to the longitudinal axis A of stent graft 130.

[0067] The graft portion 150 may include a plurality of flow channels 140 extending through the stent graft 130. The channels 140 may provide for fluid flow between the first end 131 and the second end 132. Each channel 140 may be sealed from the others of the channels 140. Each of the channels 140 may be formed from the graft portion 150. Each of the channels 140 may include an inlet at one end of the stent graft 130 and an outlet at an opposite end of the stent graft 130 (e.g., at either the first end 131 or the second end 132). The cylindrical walls 133, 135 may offset the inlets / outlets of the channels 140 from the terminal rims of the respective first and second ends 131, 132. Each of the channels 140 may be parallel to the longitudinal axis A of the stent graft 130. The channel 140 does not have to be supported by a self-expanding wire stent (ie, between the first and second ends 131, 132).

[0068] The channels 140 of the stent graft 130 can include first, second, third, and fourth channels 141-144. The stent graft 130 can include channels 141-144 to form a stent graft hub for use with a prosthesis in a patient's aortic arch and to facilitate bridging an aneurysm and connecting multiple branch arteries extending from the aortic arch to the stent graft hub. Other examples of stent grafts can include more or fewer channels. The number of channels can be based on the application, the planned prosthesis, and / or the location of use (e.g., aortic arch, thoracic aorta, or other).

[0069] The diameter of the channels 140 may be uniform between the inlet and outlet ports of each channel. Thus, there may be one diameter representing each of the channels 140. The first channel 141 may be a main or primary channel having a diameter 141a. The diameter 141a may be larger than any or all of the remaining diameters of the channels in the plurality of channels 140. The second channel 142 may have a diameter 142a. The third channel 143 may have a diameter 143a. The fourth channel 144 may have a diameter 144a.

[0070] Desirably, the graft portion 150 can be formed from a single sleeve or tube comprising one or more sheets of material (e.g., bonded together). Each of the channels 140 can be formed from the graft portion 150 along a straight connection segment. The straight connection segment can comprise a fusion line. The straight connection segment can run parallel to the longitudinal axis A of the stent graft 130. The straight connection segment can comprise the material of the graft portion 150 connected to each other along a line (e.g., via sutures, melt / fusion, or adhesives, or other means). The fusion line can be formed by melting the graft material, such as by heating above its melting temperature or ultrasonic welding. In certain embodiments, the graft material of the graft portion 150 can include PTFE, and the straight connection segment can comprise a fused portion of PTFE. The fusion line can provide a superior connection mechanism compared to sutures or adhesives. The bonding and intermixing of the materials of the different portions of the graft portion 150 can form the channel 140 without the need to introduce additional materials. This simplifies the manufacturing process and reduces the risk of foreign bodies being present in the vessel. Alternatively, the graft portion 150 can include a woven material, such as woven polyethylene terephthalate (DACRON), and the straight connection segments can include sutures.

[0071] In this example, the second channel 142 can be separated from the first channel 141 by a straight connecting segment 151 in the graft portion 150. In this example, the third channel 143 can be separated from the first channel 141 by a straight connecting segment 152 in the graft portion 150. In this example, the fourth channel 144 can be separated from the first channel 141 by a straight connecting segment 153 in the graft portion 150. Each of the straight connecting segments can include a width 151a, 152a, 153a that extends between the associated channel portions 140. In certain embodiments, the widths 151a, 152a, 153a can be between 1.0 mm and 2.0 mm, or between 0.5 mm and 5 mm.

[0072] Assuming there is no stretching or folding or overlapping of graft portion 150 at first and second ends 131, 132, the circumference of the single tube may be equal to the sum of the circumference of channel 140 and twice the length of the width between channels (e.g., 151a-153a). Assuming graft portion 150 and channel 140 are circular and the width between channels is small, the sum of the circumferences of channels 140 may be approximately equal to the circumference of a single tube having a circular circumference (e.g., π*W=π(141a+142a+143a+144a...)).

[0073] FIG. 2C shows a cross section along line 2C-2C of FIG. 1F extending through first channel 141 and third channel 143. Channel 140 can extend from first open end 131 to second open end 132 along a channel length 145. Channel length 145 can extend parallel to the longitudinal axis of channel 140 and / or the axes of channels 141-144. Channel length 145 can extend from cylindrical wall 133 to cylindrical wall 135 (e.g., to the base of the cylindrical wall). Desirably, channel length 145 can be about 75% or 50%-90% of hub length L. This arrangement can provide a compact arrangement for multi-lumen stent graft 130. As described below, a longer stent graft may be too difficult to deploy and / or too difficult to connect with a connecting stent, but the compact arrangement of the stent graft 130 may provide for use in a tight and crowded environment such as the aortic arch. This compact arrangement, along with a low hub length L (e.g., 4-9 cm), may allow the multi-lumen stent graft 130 to be placed in multiple different locations within the aortic arch (e.g., either the ascending or descending aorta). A ratio of the channel length 145 to the total length L within the high range provided herein and shown in FIG. 2C may also provide sufficient length (and surface area) of the channel 140 to reliably engage with a connecting stent, as described below. The total surface area overlap between the connecting stent and the channel may be directly proportional to the strength of the connection between the connecting stent and the stent graft 130. In other configurations, the channel length 145 may be 75%-90% or 50%-95% of the hub length L. Each of the channels 140 can extend a channel length 145 (e.g., the channels 140 can have the same length). The channels 140 can also extend along a seal length 146. The seal length 146 can extend parallel to the longitudinal axis of the channel 140 and / or the axes of the channels 141-144. The seal length 146 can extend from the upper end to the lower end of any of the straight connection segments 151-153. Desirably, the seal length 146 can be between 75% and 100% of the channel length 145.This arrangement can provide a compact construction for the multi-lumen stent graft 130. In other configurations, the seal length 146 can be between 75% and 90% of the hub length L, or between 50% and 95%.

[0074] 3A-3B show the stent portion 190 separated from the graft portion 150. The stent portion 190 may comprise a self-expanding wire structure that can be folded so as to be insertable into a body vessel, such as an artery or vein, via a catheter. The material of the stent portion 190 may include Nitinol and other similar (e.g., bioinert) materials, such as materials. The stent portion 190 may comprise a plurality of wires formed into a honeycomb or cross pattern according to conventional structures known for the construction of wire stents. The stent portion 190 may include a first end 191 and a second end 192. The stent portion 190 may be generally formed as a cylinder having a central passageway extending therethrough. The first end 131 may terminate at a plurality of junctions and intersections of the wires that form the stent portion 190. The stent portion 190 may be coaxially mounted on the graft portion 150. The stent portion 190 may be connected to the graft portion 150 using sutures or other mechanical fasteners. Stent portion 190 may include wires formed in a diamond-shaped overlapping pattern.

[0075] In certain embodiments, the wires may include barbs or other projections that can be used to more securely attach to other stent grafts or portions of the vessel wall. The barbs may be extensions of the stent portion 190. The barbs may extend longitudinally and / or radially outward or inward of the first and / or second ends 131, 132. The barbs may provide connection points with the interior of the person's vessel (e.g., facing outward) and / or with a connecting graft that may be attached within the stent graft 130 (e.g., facing inward). Radiopaque material and / or markings may also be included in the stent graft 130, such as attached to the graft portion 150 or to the stent portion 190.

[0076] 4A-4H show a graft portion 150 without a stent portion 190 and with various configurations 140a-d for the channels 140 extending therethrough. The channels 140 can include two, three, four, five, six, or more channels. The channels 140 can be formed using straight connecting segments in a graft portion 150 formed from a single tube. The stent graft 130 has various numbers and arrangements of channels 140. In one embodiment, a set of stent grafts can be compiled from which one or more stent grafts can be selected for use during surgery. Selection from the set can be based on the intended use of the particular stent graft 130 (e.g., the arterial branching pattern of the patient). Preferably, the set reduces the need for custom components or supports a large stock of physiologically specific components.

[0077] The relative diameters of the channels 140a-140d to the width W can be based on the number of channels. In a particular example, the channel diameters can follow the table below. [Table 1]

[0078] 5-6 show another embodiment of a stent graft 330 including a graft portion 350 and a stent portion 390. The stent graft 330 can include a first end 331 and a second end 332. The first end 331 can be surrounded by a graft portion 350 that is folded outwardly over the end of the stent portion 390. The graft portion 350 can include a channel 340 having an inlet that opens into the first end 331. The second end 332 can be open between the graft portion 350 and the stent portion 390. As shown in FIG. 6, the graft portion 350 can be assembled over the outer surface of the stent portion 390. The first end 331 includes a closed end of the graft portion 350 and the second end 332 includes an opening between the channel 340 and the stent portion 390. The outlet of channel 340 is not directly connected to graft portion 350 and / or stent portion 390, but instead is "floating". Advantageously, this allows for increased movement of channel 340 relative to stent portion 390 and / or the vessel wall.

[0079] 7-14 illustrate an apparatus and method for manufacturing a stent graft, such as the stent graft 130 described above. The apparatus may include a mandrel assembly 400. The mandrel assembly 400 may include end caps 421, 422 and a plurality of channel mandrels 440. The channel mandrel 440 may include any number of members, such as members 441, 442, 443, depending on the desired arrangement of the completed stent graft 130. The end cap 421 may include a plurality of receptacles therein. The receptacles may include cylindrically shaped openings, such as openings 431, 432, 433. The cylindrically shaped openings may be sized to receive one end of each of the plurality of channel mandrels 440. The end cap 421 may be a mirror image of the end cap 422. The cylindrically shaped openings of the end cap 422 may receive opposite ends of each of the plurality of channel mandrels 440. The arrangement of the cylindrical openings can be selected according to the desired arrangement of the flow channels 140 for the completed stent graft 130. Optionally, the cylindrical openings can be connected by one or more slits in the end caps 421, 422, as shown in FIG.

[0080] The end caps 421, 422 may have a generally cylindrical body having a diameter D. The diameter D may be equivalent to the diameter W of the stent graft 130. The channel mandrels 440 may each include a cylindrical body having a diameter, such as diameters D1, D2, D3, etc. The diameters D1-D3 may correspond to the desired diameters of the flow channel 140 of the completed stent graft 130.

[0081] Channel mandrel 440 can be assembled into the openings in each of end caps 421, 422, as shown in Figure 9. Tubular graft portion 150 can be assembled over the assembled mandrel. Opposing ends of graft portion 150 can be aligned over end caps 421, 422. A central portion of graft portion 150 can be aligned with channel mandrel 440.

[0082] As shown in FIGS. 10-11, the material of the graft portion 150 can be forced into contact with itself around the channel mandrel 440 (e.g., members 441, 442, 443, etc.) of the mandrel assembly 400. The contacting portions of the graft portion 150 can be connected to one another to form straight connecting segments (e.g., segments 151, 152, 153, etc.) that define the channel 140 of the hub 130. As shown on the right side of FIG. 11, the material of the graft portion 150 is tightly wrapped around the member 443 and sealed to itself at the straight connecting segment 152 to form the flow channel 143. As shown on the left side of FIG. 11, the material of the graft portion 150 is tightly wrapped around the member 442 and sealed to itself at the straight connecting segment 151 to form the flow channel 142. As shown in the center of FIG. 11, the material of graft portion 150 is tightly wrapped around member 441 and sealed to itself at straight connecting segments 151 and 152 to form flow channel 141 .

[0083] The straight connection segments can define (alone or in combination) the flow channels 140 of the stent graft 130. Each straight connection segment can include a fusion line of material of the graft portion 150. The pattern of the fusion lines can vary. In certain examples, the pattern of the fusion lines can be continuous or intermittent. In certain examples, the pattern of the fusion lines can be straight, can include multiple straight lines (e.g., zigzag), or can be curved (e.g., sinusoidal). In certain examples, another material can be included in one or more straight connection segments. The additional material can include an intermediate layer of PTFE, fluorinated ethylene propylene (FEP), or other material. The additional material can be disposed between the contacting portions of the graft portion 150.

[0084] The fusion may be accomplished using heated iron 481 and / or a second iron 482 or other backing material. Iron 481 may be inserted between adjacent members of the channel mandrel 440, if desired. Alternatively, the straight connecting segments may be sewn, glued, or otherwise connected. Alternatively, the fusion line may be formed using ultrasonic welding with an ultrasonic welding tip.

[0085] This process can be repeated until all of the flow channels 140 are formed. In certain embodiments, the graft portion 150 can be formed into the flow channels 140 starting with the small diameter member 440. After the smaller flow channels are completed, the largest (primary) flow channel can be completed. The largest diameter member 441 can form the primary flow channel 141 having the largest diameter.

[0086] After forming the flow channel 140, the stent portion 190 can be assembled coaxially over the graft portion 150 while still on the mandrel assembly 400, as shown in Figures 12-14. The stent portion 190 can be positioned over the flow channel 140. Either end of the stent portion 190 can overlap the unfolded ends 133a, 135a of the graft portion 150. Once positioned, the unfolded ends 133a, 135a can be folded over the ends of the stent portion 190, either sequentially or simultaneously, and secured in place (e.g., by suturing, fusing, adhesive, or other methods). For example, the ends 133a and / or 135a can be melted to encapsulate the ends of the stent portion 190. Instead of folding over the ends of the graft portion 150, an additional sheet or sheets of PTFE or other material can be placed over the stent portion 190. The additional material and ends 133a and / or 135a can sandwich the ends of stent portion 190. The additional material can then be fused to ends 133a and / or 135a of graft portion 150. In certain embodiments, the additional material can completely encapsulate stent portion 150.

[0087] Any further finishing steps may be completed and the completed stent graft 130 may be removed by disassembly of the mandrel assembly 400 .

[0088] 15-19 illustrate an exemplary surgical method for placing a prosthesis including a stent graft 130 within the aortic arch 1 to bridge an aneurysm 1a. Although described in the context of an aortic aneurysm, the techniques discussed herein can be used to address various types of treatment sites (e.g., the thoracic aorta). Because the aneurysm is located within the aortic arch, it is likely necessary to bridge two or more branch arteries within the aortic arch. As previously mentioned, rather than relying on a custom-made stent graft, the prosthesis can be placed using one or more stent grafts 130 along with one or more connecting stent grafts (e.g., connecting stent grafts 522, 523, 524, 525). Each of the connecting stent grafts can generally be formed as a tube of graft material with or without a self-expanding stent. The diameter and length of the connecting stent grafts can be selected based on the planned placement within the prosthesis. For example, the ends of the connecting stent grafts can have different diameters to better fit within a channel or branch artery.

[0089] The number of stent grafts 130 used, the number of flow channels 140 within the stent grafts 130, and the lengths of the connecting stent grafts 522-525 may vary, but they may be selected from a finite set of stent grafts. This may facilitate and streamline the planning and execution of the surgical procedure for a wide variety of prostheses. Specific layouts of the prostheses are described below, but the features of the stent graft hubs 130 and connecting stents may be adapted to any arterial branching pattern without the need for custom components.

[0090] A steerable catheter and / or guidewire 501 may be advanced into the aortic arch 1. The guidewire may be inserted through an incision providing access to the femoral artery and then advanced upward into the aortic arch. The guidewire 501 may be advanced against the aneurysm 1a (e.g., above the aneurysm 1a and into the ascending aorta). A catheter 503 carrying the folded stent graft 130 may be advanced along the guidewire 501. The folded stent graft 130 may be positioned against the aneurysm 1a and deployed using the catheter 503. The stent graft 130 may be held in place by radial expansion of the stent portion 190 and / or via hooks and barbs in the inner wall of the aortic arch 1.

[0091] As shown in FIG. 17, a guidewire and / or catheter 512 can be advanced through the brachiocephalic artery 2 (either via the right subclavian artery or the right common carotid artery) into one of the channels 140 of the stent graft 130. A connecting stent graft 522 can be deployed by the catheter 512. A first end of the connecting stent graft 522 can be positioned within the channel 140 of the stent graft 130. A second end of the connecting stent graft 522 can be positioned within the brachiocephalic artery 2. The connecting stent graft 522 can be deployed from the catheter 512 and radially expanded within the channel 140 of the stent graft 130. The connecting stent graft 522 can be held in place by radial expansion of its stent portion and / or by hooks and barbs within the inner wall of the channel 140. The stent graft 522 can thereby provide a fluid flow path for blood flow between the stent graft 130 and the brachiocephalic artery 2.

[0092] Another guidewire and / or catheter 513 can be advanced through the left common carotid artery 3 into another one of the channels 140 of the stent graft 130. The connecting stent graft 523 can be deployed by the catheter. A first end of the connecting stent graft 523 can be positioned within the channel 140 of the stent graft 130. A second end of the connecting stent graft 523 can be positioned within the left common carotid artery 3. The connecting stent graft 523 can be deployed from the catheter 513 and radially expanded within the channel 140 of the stent graft 130. The connecting stent graft 523 can be held in place by radial expansion of its stent portion and / or by hooks and barbs within the inner wall of the channel 140. The connecting stent graft 523 can thereby provide a fluid flow path for blood flow between the stent graft 130 and the left common carotid artery 3.

[0093] Another guidewire and / or catheter 514 can be advanced through the left subclavian artery 4 into another one of the channels 140 of the stent graft 130. A connecting stent graft 524 can be deployed by the catheter. A first end of the connecting stent graft 524 can be positioned within the channel 140 of the stent graft 130. A second end of the connecting stent graft 524 can be positioned within the left subclavian artery 4. The connecting stent graft 524 can be deployed from the catheter 514 and radially expanded within the channel 140 of the stent graft 130. The connecting stent graft 524 can be held in place by radial expansion of its stent portion and / or by hooks and barbs within the inner wall of the channel 140. The connecting stent graft 524 can thereby provide a fluid flow path for blood flow between the stent graft 130 and the left subclavian artery 4. Alternatively, the second end of the connecting stent graft 524 may be positioned within the aorta 1, such as below the stent graft 130 or within the descending aorta.

[0094] Another guidewire, such as guidewire 501, and / or a catheter can be advanced into another one of the channels 140 of the stent graft 130, such as the primary flow channel, within the aortic arch. Another connecting stent graft 525 can be deployed by the catheter. A first end of the connecting stent graft 525 can be positioned within the channel 140 of the stent graft 130 (such as the primary channel 141). A second end of the connecting stent graft 525 can be positioned within the aorta, such as within the aortic arch. The connecting stent graft 525 can be deployed from the catheter and radially expanded within the channel 140 of the stent graft 130. The connecting stent graft 525 can be held in place by radial expansion of its stent portion and / or by hooks and barbs within the inner wall of the channel 140. The stent graft 525 can thereby provide a fluid flow path for blood flow between the stent graft 130 and the aorta, bridging the aneurysm 1a.

[0095] 20 shows another exemplary prosthesis including a stent graft 130 in the aortic arch 1 for bridging an aneurysm 1a. A guidewire can be advanced relative to the aneurysm 1a. A catheter carrying a folded stent graft 130 can be advanced along the guidewire. The folded stent graft 130 can be positioned relative to the aneurysm 1a and deployed using a catheter (e.g., below the aneurysm 1a and into the descending aorta).

[0096] A guidewire and / or catheter can be advanced through the brachiocephalic artery 2 (e.g., via either the right subclavian artery or the right common carotid artery) into one of the channels 140 of the stent graft 130. The connecting stent graft 522 can be deployed by the catheter 512. A first end of the connecting stent graft 522 can be disposed within the channel 140 of the stent graft 130. The first end of the connecting stent graft can be deployed within the channel 140 and radially expanded. A second end of the connecting stent graft 522 can be disposed within the brachiocephalic artery 2. The stent graft 522 can thereby provide a fluid flow path for blood flow between the stent graft 130 and the brachiocephalic artery 2.

[0097] Another guidewire and / or catheter can be advanced through the left common carotid artery 3 into another one of the channels 140 of the stent graft 130. The connecting stent graft 523 can be deployed by the catheter. A first end of the connecting stent graft 523 can be disposed within the channel 140 of the stent graft 130. The first end of the connecting stent graft can be deployed and radially expanded within the channel 140. A second end of the connecting stent graft 523 can be disposed within the left common carotid artery 3. The connecting stent graft 523 can thereby provide a fluid flow path for blood flow between the stent graft 130 and the left common carotid artery 3.

[0098] Another guidewire and / or catheter can be advanced through the left subclavian artery 4 into another one of the channels 140 of the stent graft 130. The connecting stent graft 524 can be deployed by the catheter. A first end of the connecting stent graft 524 can be disposed within the channel 140 of the stent graft 130. The first end of the connecting stent graft can be deployed and radially expanded within the channel 140. A second end of the connecting stent graft 524 can be disposed within the left subclavian artery 4. The connecting stent graft 524 can thereby provide a fluid flow path for blood flow between the stent graft 130 and the left subclavian artery 4.

[0099] Another guidewire and / or catheter can be advanced through another of the channels 140 of the stent graft 130, such as the primary flow channel, within the aortic arch. Another connecting stent graft 525 can be deployed by the catheter. A first end of the connecting stent graft 525 can be positioned within the aorta, such as within the aortic arch. A second end of the connecting stent graft 525 can be positioned within the channel 140 of the stent graft 130. The second end of the connecting stent graft can be deployed within the channel 140 and radially expanded. The stent graft 525 can thereby provide a fluid flow path for blood flow between the stent graft 130 and the aorta, bridging the aneurysm 1a.

[0100] Figure 21 shows another exemplary prosthesis including a stent graft 130 in the aortic arch 1 for bridging the aneurysm 1a. The prosthesis may have the same structure as that shown above in Figure 19. According to this embodiment, the stent graft 130 may be directly connected to the heart valve 510 and / or may form part of the heart valve.

[0101] 22-23 show another exemplary prosthesis including first and second stent grafts 130a, 130b in the aortic arch 1 for bridging the aneurysm 1a. The stent grafts 130a, 130b can be deployed as described above (e.g., one in the ascending aorta and one in the descending aorta). The two stent grafts 130a, 130b can be placed on either side of the aneurysm 1a.

[0102] A guidewire and / or catheter can be advanced through the brachiocephalic artery 2 (e.g., via either the right subclavian artery or the right common carotid artery) into one of the channels 140 of the stent graft 130a. The connecting stent graft 522 can be deployed by the catheter 512. A first end of the connecting stent graft 522 can be positioned within the channel 140 of the stent graft 130a and expanded. A second end of the connecting stent graft 522 can be positioned within the brachiocephalic artery 2. The stent graft 522 can thereby provide a fluid flow path for blood flow between the stent graft 130a and the brachiocephalic artery 2.

[0103] Another guidewire and / or catheter can be advanced through the left common carotid artery 3 into another one of the channels 140 of the stent graft 130a. The connecting stent graft 523 can be deployed by the catheter. A first end of the connecting stent graft 523 can be positioned within the channel 140 of the stent graft 130a and expanded. A second end of the connecting stent graft 523 can be positioned within the left common carotid artery 3. The connecting stent graft 523 can thereby provide a fluid flow path for blood flow between the stent graft 130a and the left common carotid artery 3.

[0104] Another guidewire and / or catheter can be advanced through the left subclavian artery 4 into another one of the channels 140 of the stent graft 130b. The connecting stent graft 524 can be deployed by the catheter. A first end of the connecting stent graft 524 can be positioned within the channel 140 of the stent graft 130b and expanded. A second end of the connecting stent graft 524 can be positioned within the left subclavian artery 4. The connecting stent graft 524 can thereby provide a fluid flow path for blood flow between the stent graft 130b and the left subclavian artery 4.

[0105] Another guidewire and / or catheter can be advanced through one of the channels 140 of stent graft 130a, such as the primary flow channel, and the other of the channels 140 of stent graft 130b, within the aortic arch. Another connecting stent graft 525 can be deployed by the catheter. A first end of the connecting stent graft 525 can be positioned and expanded within stent graft 130a, such as within channel 140. A second end of the connecting stent graft 525 can be positioned and expanded within channel 140 of stent graft 130b. The connecting stent graft 525 can thereby provide a fluid flow path for blood flow between stent graft 130a and stent graft 130b, bridging the aneurysm 1a.

[0106] 24A-24B show an example of a multi-lumen stent graft 630 that is similar to stent graft 130, but with the differences described below. Stent graft 630 can include a graft portion 650 and a stent portion 690. Stent portion 690 can comprise a shape memory alloy, such as superelastic Nitinol or similar material. Graft portion 650 can be made of a single sheet formed into a tube or a sheet of PTFE. Stent graft 630 can include a first open end 631 and a second open end 632 opposite first open end 631. First end 631 and second end 632 can have a circular shape, but this is not required. Second end 632 can have the same shape as first end 631, but this is not required. First and second ends 631, 632 can include a base and an upper or lower rim.

[0107] The stent graft 630 can have a diameter W. The stent graft 630 can have a hub length L from the first end 631 to the second end 632. The hub length L can extend from an upper rim at the first end 631 to a lower rim at the second end 632. The hub length L can be between about 6 cm and 65 cm, depending on the application.

[0108] The first end 631 can have a length 631a. The length 631a can extend from the base to the upper rim. The second end 632 can have a length 632a. The length 632a can extend from the base to the lower rim. The lengths 631a, 632a can be different. Desirably, the length 631a can be greater than the length 631a. The length 631a can be 2 to 5 times greater than the length 632a. This extended length can facilitate the connection of a stent bridge deployed inside the first end 631. The length 631a can be 40% to 70% of the hub length L.

[0109] The graft portion 650 may include a plurality of flow channels 640 extending through the stent graft 630. The channels 640 may provide for fluid flow between the first end 631 and the second end 632. Each channel 640 may be sealed from the others of the channels 640. Each of the channels 640 may be formed from the graft portion 650. Each of the channels 640 may include an inlet at one end of the stent graft 630 and an outlet at an opposite end of the stent graft 630 (e.g., at either the first end 631 or the second end 632). The cylindrical walls of the first and second ends 631, 632 may offset the inlet / outlet of the channel 640 from the terminal rims of the respective first and second ends 631, 632. Each of the channels 640 may be parallel to the longitudinal axis A of the stent graft 630. The channel 640 may not be supported by a self-expanding wire stent (i.e., between the first and second ends 631, 632). The channel 640 of the stent graft 630 may include a first and a second channel. Other examples of stent grafts may include more or fewer channels. The number of channels may be based on the application, the planned prosthesis, and / or the location of use (e.g., aortic arch, thoracic aorta, or other).

[0110] The channel 640 can extend from the first open end 631 to the second open end 632 along a channel length 645. The channel length 645 can extend parallel to the longitudinal axis of the channel 640 and / or the axis of the channel. The channel length 645 can extend from the cylindrical wall at the first end 631 to the cylindrical wall at the second end 632 (e.g., to the base of the cylindrical wall). Desirably, the channel length 645 can be between 40% and 70% of the hub length L, or other ranges as described above.

[0111] 25A-25C show another exemplary prosthesis including a stent graft 630 in the aortic arch 1 for bridging an aneurysm 1a. Thus, a guidewire can be advanced relative to the aneurysm 1a. A catheter carrying the folded stent graft 630 can be advanced along the guidewire. The folded stent graft 630 can be positioned relative to the aneurysm 1a and deployed using a catheter (e.g., above the aneurysm 1a and / or in the descending aorta). A first end 631 of the stent graft 630 can be distal to a second end 632 and extend toward the thoracic aorta.

[0112] A guidewire and / or catheter can be advanced through any of the branch arteries 2-4 and through the second end 632 into one of the channels 640 of the stent graft 630. The connecting stent graft 524 can be deployed by a catheter with a first end of the connecting stent graft 524 disposed within the channel 640 of the stent graft 630. A second end of the connecting stent graft 524 can be disposed within the branch artery 2-4. The connecting stent graft 524 can thereby provide a fluid flow path for blood flow between the stent graft 630 and the branch artery. Another guidewire and / or catheter can be advanced within the aortic arch through another of the channels 640 of the stent graft 630, such as the primary flow channel. Another connecting stent graft 525 can be deployed by a catheter. A first end of the connecting stent graft 525 can be disposed within the aorta, such as within the aortic arch. A second end of the connecting stent graft 525 can be disposed within the channel of the channel 640. This allows the stent graft 525 to provide a fluid flow path for blood flow between the stent graft 630 and the aorta, bridging the aneurysm 1a.

[0113] Another guidewire and / or catheter can be advanced into the aorta (e.g., from the thoracic aorta) and into the first end 631 of the stent graft 630. The bridge stent graft 526 can be deployed by the catheter. The bridge stent graft 526 can generally be formed as a tube of graft material with or without a self-expanding stent. The diameter and length of the bridge stent graft 526 can be selected based on the planned placement within the prosthesis. For example, the length of the stent graft 526 can be selected to bridge another aneurysm in the descending aorta 1. The first end of the connecting stent graft 525 can be positioned within the first end 631 of the stent graft 630. The first end of the connecting stent graft 525 can be radially expanded within the first end 631 of the stent graft 630. The connecting stent graft 525 can function to elongate the first end 631. A second end of the connecting stent graft 526 can be positioned within the aorta, for example within the descending aortic arch or within the thoracic aorta, such that the connecting stent graft 526 can provide a fluid flow path for blood flow between the stent graft 630 and the descending aorta.

[0114] 26-29 show an example of a multi-lumen stent graft 730 that is similar to stent graft 130, but with the differences described below. Stent graft 730 may include a graft portion 750 and a stent portion (not shown). Desirably, graft portion 750 may be made from a sheet of woven Dacron. Stent graft 730 may include a first open end 731 and a second open end 732 opposite first open end 731. Graft portion 750 may include a plurality of flow channels 740 extending through stent graft 730. Channels 740 may provide for fluid flow between first end 731 and second end 732. Channels 740 may be formed from a single tube of woven Dacron material. Each of channels 740 may be separated from others of channels 740 by one or more sutures 751, 752 of Dacron material. The channels 740 of the stent graft 730 may include first, second and third channels 741-743. Alternatively, other numbers of channels may be included in the channels 740.

[0115] The stent graft 730 may further include an additional channel 744. The channel 744 may be formed separately from the graft portion 750. The channel 744 may be formed by stitching, adhesive, woven material, or other means. The channel 741 may include a first end 781 and a second end 782. The first and / or second ends 781, 782 may include excess or flared material. The first and second ends 731, 732 may include openings 744a, 744b in the graft portion 750. The openings 744a, 744b may have a diameter corresponding to the diameter of the ends 781, 782. The ends 781, 782 may be attached over the openings 744a, 744b to form one of the channels 740 extending from the first end 131 to the second end 132. The ends 781, 782 may be attached to the graft portion 750 by sutures, adhesives, and / or other mechanical means. Specific Terms

[0116] Orientation terms used herein, such as "superior", "lower", "upper", "lower", "proximal", "distal", "longitudinal", "lateral", and "end" are used in the context of the illustrated examples. However, the present disclosure should not be limited to the illustrated orientations. Indeed, other orientations are possible and within the scope of the present disclosure. Circular terms, such as diameter or radius, used herein should be understood not to require a perfectly circular structure, but rather should apply to any suitable structure having a cross-sectional area that can be measured from side to side. General shape terms, such as "circular", "cylindrical", "semicircular", or "semi-cylindrical", or any related or similar term, need not strictly follow the mathematical definition of a circle or cylinder or other structure, but can encompass structures that are reasonably close.

[0117] Conditional language such as "can," "could," "might," or "may" is generally intended to convey that a particular example includes or does not include certain features, elements, and / or steps, unless specifically stated otherwise or understood otherwise within the context in which it is used. Thus, such conditional language does not generally imply that the features, elements, and / or steps are in any way required in one or more examples.

[0118] Conjunctions such as the phrase "at least one of X, Y, and Z," unless otherwise noted, are otherwise understood in the context in which they are generally used to convey that an item, term, etc. can be either X, Y, or Z. Thus, such conjunctives are generally not intended to imply that a particular embodiment requires the presence of at least one of X, at least one of Y, and at least one of Z.

[0119] The terms "approximately," "about," and "substantially," as used herein, refer to an amount close to the stated amount that still performs a desired function or achieves a desired result. For example, in some instances, as the context may dictate, the terms "approximately," "about," and "substantially" may refer to an amount that is 10% or less of the stated amount. The term "generally," as used herein, refers to a value, amount, or characteristic that primarily includes or tends toward a particular value, amount, or characteristic. As an example, in certain instances, as the context may dictate, the term "approximately parallel" may refer to a deviation of 20 degrees or less from exact parallelism. All ranges include the endpoints. overview

[0120] Several exemplary examples of stent grafts and related procedures are disclosed. Although the disclosure has been described with respect to certain exemplary examples and uses, other examples and other uses are within the scope of the disclosure, including examples and uses that do not provide all of the features and advantages described herein. Components, elements, features, operations, or steps may be arranged or performed differently than described, and components, elements, features, operations, or steps may be combined, merged, added, or removed in various examples. All possible combinations and subcombinations of the elements and components described herein are intended to be included in the disclosure. No single feature or group of features is required or essential.

[0121] Moreover, certain features described in this disclosure in the context of separate embodiments can also be implemented in combination in a single embodiment. Conversely, various features described in the context of a single implementation can also be implemented in multiple implementations separately or in any suitable subcombination. Furthermore, although features may be described above as acting in a particular combination, one or more features from a claimed combination can, in some cases, be deleted from the combination, and the combination can be claimed as a subcombination or a variation of a subcombination. The invention as set forth in each of the following independent claims can include any combination or all of the features of the further inventions as set forth in each of the dependent claims.

[0122] Any portion of any of the steps, processes, structures, and / or devices disclosed or illustrated in one example of this disclosure may be combined with or used in place of any other portion of the steps, processes, structures, and / or devices disclosed or illustrated in a different example or flow chart. The examples described herein are not intended to be separate and distinct from one another. Combinations, variations, and embodiments of the disclosed features are within the scope of this disclosure.

[0123] Although operations may be shown in the figures or described herein in a particular order, such operations need not be performed in the particular order shown, or in sequential order, or all operations need not be performed to achieve desirable results. Other operations not shown or described may be incorporated into the example methods and processes. For example, one or more additional operations may be performed before, after, simultaneously with, or between any of the described operations. Furthermore, in some implementations, operations may be rearranged or reordered. Also, it should be understood that the separation of various components in the above implementations does not require such separation in all implementations, and that the described components and systems may generally be incorporated together in a single product or packaged in multiple products. Furthermore, some implementations are within the scope of the present disclosure.

[0124] Further, although illustrative examples have been described, any examples having equivalent elements, modifications, omissions, and / or combinations are within the scope of the present disclosure. Moreover, although certain aspects, advantages, and novel features are described herein, not necessarily all such advantages are achieved in accordance with any particular example. For example, some examples within the scope of the present disclosure achieve one advantage or group of advantages taught herein without necessarily achieving other advantages taught or suggested herein. Moreover, some examples may achieve advantages different from those taught or suggested herein.

[0125] Some examples are described in conjunction with the accompanying drawings. Although the figures are drawn and / or shown to scale, such scale should not be limiting and dimensions and proportions other than those shown are contemplated and are within the scope of the disclosed invention. Distances, angles, etc. are merely illustrative and do not necessarily bear an exact relationship to the actual dimensions and layout of the illustrated devices. Components can be added, removed, and / or rearranged. Furthermore, the disclosure herein of any particular features, aspects, methods, properties, attributes, qualities, attributes, elements, etc., associated with the various examples can be used in all other examples described herein. Furthermore, any method described herein can be implemented using any apparatus suitable for performing the recited steps.

[0126] For purposes of summarizing the disclosure, certain aspects, advantages, and features of the invention are described herein. Not all, or any, such advantages are necessarily achieved in accordance with any particular example of the invention disclosed herein. No aspect of the disclosure is essential or required. In many examples, the apparatus, systems, and methods may be configured differently than shown in the figures or descriptions herein. For example, various functions provided by the illustrated modules may be combined, rearranged, added, or deleted. In some implementations, additional or different processors or modules may perform some or all of the functions described in the figures and with reference to the illustrated examples. Many implementation variations are possible. Any of the features, structures, steps, or processes disclosed herein may be included in any example.

[0127] In summary, various examples of stent grafts and related methods are disclosed. The disclosure extends beyond the specifically disclosed examples to other alternatives and / or other uses of the examples, as well as certain modifications and equivalents thereof. Moreover, the disclosure expressly contemplates that various features and aspects of the disclosed examples can be combined with or substituted for one another. Thus, the scope of the disclosure should not be limited by the specific disclosed examples described above, but should be determined only by a fair reading of the claims.

Claims

1. 1. A multi-lumen expandable stent graft comprising: a graft sleeve including a polymeric material forming first, second and third flow channels between a first open end and a second open end; a self-expanding wire stent mounted coaxially over the graft sleeve and secured to the graft sleeve at the first and second open ends; Equipped with the first flow channel is aligned parallel to a longitudinal axis of the stent graft and includes inlet and outlet ports spaced inwardly from the first and second open ends of the graft sleeve; the second flow channel is aligned parallel to the longitudinal axis of the stent graft and includes inlet and outlet ports spaced inwardly from the first and second open ends of the graft sleeve; the third flow channel is aligned parallel to the longitudinal axis of the stent graft and includes inlet and outlet ports spaced inwardly from the first and second open ends of the graft sleeve. Multi-lumen expandable stent graft.

2. A multi-lumen expandable stent graft, comprising: a graft sleeve including a polymeric material forming first, second and third flow channels between a first open end and a second open end; a self-expanding wire stent mounted coaxially over the graft sleeve and secured to the graft sleeve at the first and second open ends; Equipped with the first flow channel is aligned parallel to a longitudinal axis of the stent graft and includes inlet and outlet ports spaced inwardly from the first and second open ends of the graft sleeve; the second flow channel is aligned parallel to the longitudinal axis of the stent graft and includes inlet and outlet ports spaced inwardly from the first and second open ends of the graft sleeve; the third flow channel is aligned parallel to the longitudinal axis of the stent graft and includes inlet and outlet ports spaced inwardly from the first and second open ends of the graft sleeve; the channel lengths of the first, second and third flow channels are between 50% and 90% of a hub length extending from an upper rim of the first open end to a lower rim of the second open end; Multi-lumen expandable stent graft.

3. A multi-lumen expandable stent graft, comprising: a graft sleeve including a polymeric material forming first, second and third flow channels between a first open end and a second open end; a self-expanding wire stent mounted coaxially over the graft sleeve and secured to the graft sleeve at the first and second open ends; Equipped with the first flow channel is aligned parallel to a longitudinal axis of the stent graft and includes inlet and outlet ports spaced inwardly from the first and second open ends of the graft sleeve; the second flow channel is aligned parallel to the longitudinal axis of the stent graft and includes inlet and outlet ports spaced inwardly from the first and second open ends of the graft sleeve; the third flow channel is aligned parallel to the longitudinal axis of the stent graft and includes inlet and outlet ports spaced inwardly from the first and second open ends of the graft sleeve; the channel lengths of the first, second and third flow channels are between 75% and 90% of a hub length extending from an upper rim of the first open end to a lower rim of the second open end; Multi-lumen expandable stent graft.

4. A multi-lumen expandable stent graft, comprising: a graft sleeve including a polymeric material forming first, second and third flow channels between a first open end and a second open end; a self-expanding wire stent mounted coaxially over the graft sleeve and secured to the graft sleeve at the first and second open ends; Equipped with the first flow channel is aligned parallel to a longitudinal axis of the stent graft and includes inlet and outlet ports spaced inwardly from the first and second open ends of the graft sleeve; the second flow channel is aligned parallel to the longitudinal axis of the stent graft and includes inlet and outlet ports spaced inwardly from the first and second open ends of the graft sleeve; the third flow channel is aligned parallel to the longitudinal axis of the stent graft and includes inlet and outlet ports spaced inwardly from the first and second open ends of the graft sleeve; a first diameter of the first flow channel is within 10%-40% of a sleeve diameter of the first and second open ends, a second diameter of the second flow channel is within 10%-40% of the sleeve diameter, and a third diameter of the third flow channel is within 50%-80% of the sleeve diameter. Multi-lumen expandable stent graft.

5. A multi-lumen expandable stent graft, comprising: a graft sleeve including a polymeric material forming first, second, third and fourth flow channels between a first open end and a second open end; a self-expanding wire stent mounted coaxially over the graft sleeve and secured to the graft sleeve at the first and second open ends; Equipped with the first flow channel is aligned parallel to a longitudinal axis of the stent graft and includes inlet and outlet ports spaced inwardly from the first and second open ends of the graft sleeve; the second flow channel is aligned parallel to the longitudinal axis of the stent graft and includes inlet and outlet ports spaced inwardly from the first and second open ends of the graft sleeve; the third flow channel is aligned parallel to the longitudinal axis of the stent graft and includes inlet and outlet ports spaced inwardly from the first and second open ends of the graft sleeve; a first diameter of the first flow channel is within 5%-25% of a sleeve diameter of the first and second open ends, a second diameter of the second flow channel is within 5%-25% of the sleeve diameter, a third diameter of the third flow channel is within 5%-25% of the sleeve diameter, and a fourth diameter of the fourth flow channel is within 50%-75% of the sleeve diameter. Multi-lumen expandable stent graft.

6. 6. The multi-lumen expandable stent graft of claim 1, wherein the first, second and third flow channels are not supported by the self-expanding wire stent.

7. A multi-lumen expandable stent graft as claimed in any one of claims 1 to 5, wherein said first and second open ends each comprise a cylindrical wall supported by said self-expanding wire stent.

8. The multi-lumen expandable stent graft of claim 7, wherein said cylindrical wall of said first open end has a length that is 2 to 5 times greater than a length of said cylindrical wall of said second open end.

9. A multi-lumen expandable stent graft comprising: a graft sleeve including a polymeric material forming first, second and third flow channels between a first open end and a second open end; a self-expanding wire stent mounted coaxially over the graft sleeve and secured to the graft sleeve at the first and second open ends; Equipped with the first flow channel is defined by a first linear connecting segment of the polymeric material, the first linear connecting segment being aligned parallel to a longitudinal axis of the stent graft, the first flow channel including inlet and outlet ports spaced inwardly from the first and second open ends of the graft sleeve; the second flow channel is formed by a second straight connecting segment of the polymeric material, the second straight connecting segment being aligned parallel to the longitudinal axis of the stent graft, the second flow channel including inlet and outlet ports spaced inwardly from the first and second open ends of the graft sleeve; the third flow channel is defined by a third linear connecting segment of the polymeric material, the third linear connecting segment being aligned parallel to the longitudinal axis of the stent graft, the third flow channel including inlet and outlet ports spaced inwardly from the first and second open ends of the graft sleeve; A multi-lumen expandable stent graft, wherein respective ends of said first, second and third straight connecting segments are spaced inwardly from said first and second open ends.

10. A multi-lumen expandable stent graft as claimed in any one of claims 1 to 5 and 9, wherein the first and second open ends comprise folded portions of the polymeric material.

11. A multi-lumen expandable stent graft as described in any one of claims 1 to 5 and 9, wherein the first and second open ends include a further layer of polymeric material encapsulating the first and second ends of the graft sleeve.

12. A multi-lumen expandable stent graft as claimed in any one of claims 1 to 5 and 9, wherein said graft sleeve comprises a single tube of said polymeric material and the total circumference of each of said flow channels is equal to the circumference of said single tube of said polymeric material.

13. the polymeric material of the graft sleeve comprises polytetrafluoroethylene (PTFE), and the first, second, and third straight connecting segments comprise fused portions of the PTFE material; the fused portion of the PTFE material is formed by melting the PTFE material above its melting temperature; the fused portion of the PTFE material is formed by ultrasonic welding; The multi-lumen expandable stent graft of claim 9 , wherein the fused portion of the first straight connection segment includes an intermediate layer of PTFE material.

14. 1. An expandable stent graft comprising: a graft sleeve defining a primary fluid flow channel between a first open end and a second open end of the graft sleeve, the graft sleeve including an exterior surface and an interior surface; a first internal channel and a second internal channel formed within the graft sleeve, each of the internal channels including an inlet and an outlet port spaced inwardly from the first and second open ends of the graft sleeve; the first internal channel is separated from the second internal channel; a self-expanding wire stent mounted coaxially over the graft sleeve and secured to the graft sleeve at the first and second open ends. Expandable stent graft.

15. An expandable stent graft comprising: a graft sleeve defining a primary fluid flow channel between a first open end and a second open end of the graft sleeve, the graft sleeve including an exterior surface and an interior surface; a first internal channel and a second internal channel formed within the graft sleeve, each of the internal channels including an inlet and an outlet port spaced inwardly from the first and second open ends of the graft sleeve; the first internal channel is separated from the second internal channel; a self-expanding wire stent mounted coaxially over said graft sleeve and secured to said graft sleeve at said first and second open ends; An expandable stent graft, wherein the channel lengths of said first and second interior channels are between 50% and 90% of a hub length extending from an upper rim of said first open end to a lower rim of said second open end.

16. An expandable stent graft comprising: a graft sleeve defining a primary fluid flow channel between a first open end and a second open end of the graft sleeve, the graft sleeve including an exterior surface and an interior surface; a first internal channel and a second internal channel formed within the graft sleeve, each of the internal channels including an inlet and an outlet port spaced inwardly from the first and second open ends of the graft sleeve; the first internal channel is separated from the second internal channel; a self-expanding wire stent mounted coaxially over said graft sleeve and secured to said graft sleeve at said first and second open ends; An expandable stent graft, wherein the channel lengths of said first and second internal channels are between 75% and 90% of a hub length extending from an upper rim of said first open end to a lower rim of said second open end.

17. An expandable stent graft comprising: a graft sleeve defining a primary fluid flow channel between a first open end and a second open end of the graft sleeve, the graft sleeve including an exterior surface and an interior surface; a first internal channel and a second internal channel formed within the graft sleeve, each of the internal channels including an inlet and an outlet port spaced inwardly from the first and second open ends of the graft sleeve; the first internal channel is separated from the second internal channel; a self-expanding wire stent mounted coaxially over said graft sleeve and secured to said graft sleeve at said first and second open ends; an expandable stent graft, wherein a first diameter of the first inner channel is within 20% to 50% of a sleeve diameter at the first and second open ends, and a second diameter of the second inner channel is within 50% to 80% of the sleeve diameter.

18. An expandable stent graft according to any one of claims 14 to 17, wherein the first and second internal channels are not supported by the self-expanding wire stent.

19. An expandable stent graft as described in any one of claims 14 to 17, wherein the first and second open ends each include a cylindrical wall supported by the self-expanding wire stent, and the inlet and outlet ports of the first and second internal channels are spaced inwardly from the respective cylindrical walls.

20. An expandable stent graft as described in any one of claims 14 to 17, wherein the first and second internal channels are spaced inwardly from their respective cylindrical walls of the graft sleeve.

21. The expandable stent graft of claim 19, wherein the graft sleeve comprises polytetrafluoroethylene (PTFE) material and the cylindrical wall comprises a folded portion of the PTFE material.

22. An expandable stent graft according to any one of claims 14 to 17, wherein the graft sleeve comprises a single tube of polymeric material, the overall circumference of each of the interior channels being equal to the circumference of the single tube of polymeric material.

23. The expandable stent graft of any one of claims 14 to 17, wherein the first and second internal channels each comprise a cylindrical wall.

24. 1. A multi-lumen expandable stent graft comprising: A graft sleeve having a sleeve diameter and formed from a polymeric material, a first open end including a first cylindrical wall having an upper rim; a second open end including a second cylindrical wall having a lower rim, the first open end being spaced from the second open end along a longitudinal axis; and a hub length extending from the upper rim at the first open end to the lower rim at the second open end; a plurality of parallel flow channels extending between the first open end and the second open end and defining a channel length between the first open end and the second open end, the channel length being between 50% and 90% of the hub length; The plurality of parallel flow channels are a first flow channel including inlet and outlet ports in communication with the respective first and second open ends of the graft sleeve, the first flow channel being aligned parallel to the longitudinal axis of the stent graft; a second flow channel including inlet and outlet ports in communication with the respective first and second open ends of the graft sleeve, the second flow channel being aligned parallel to the longitudinal axis of the stent graft; a third flow channel including inlet and outlet ports in communication with the respective first and second open ends of the graft sleeve, the third flow channel being aligned parallel to the longitudinal axis of the stent graft; a fourth flow channel including inlet and outlet ports in communication with the respective first and second open ends of the graft sleeve; a graft sleeve comprising: a self-expanding wire stent mounted coaxially over the graft sleeve and secured to the graft sleeve at the first cylindrical wall at the first open end and the second cylindrical wall at the second open end; a first diameter of the first flow channel is within a range of 5% to 25% of the sleeve diameter, a second diameter of the second flow channel is within a range of 5% to 25% of the sleeve diameter, a third diameter of the third flow channel is within a range of 5% to 25% of the sleeve diameter, and a fourth diameter of the fourth flow channel is within a range of 50% to 75% of the sleeve diameter. Multi-lumen expandable stent graft.

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