US-12616564-B2 - Branch endoprosthetic systems, devices, and method

Abstract

Bifurcated endoprosthetic devices, systems and methods are disclosed herein for treating disease of human vasculature. In various embodiments, a bifurcated endoprosthesis includes a trunk portion and a plurality of legs, where the legs are constrained such that they maintain alignment with one another. In some examples, the legs and bifurcation of an endoprosthetic device may be formed by cutting a tubular graft component along a portion of less than its entire circumference in a longitudinally central region, and then folding the tubular graft component along the uncut portion to define two legs, where the uncut portion defines the bifurcation. In some such examples, the folded tubular graft component can be coupled with a tubular trunk component to form the bifurcated endoprosthetic device.

Inventors

• Minh Nguyen
• Timothy J. O'Neill
• Aniceto Trujillo

Assignees

• W. L. GORE & ASSOCIATES, INC.

Dates

Publication Date

20260505

Application Date

20200207

Claims (20)

1. 1 . A method of manufacturing an endoprosthesis that includes a first leg, a second leg, and a bifurcation, the method comprising: providing a mandrel having a first section and a second section, the second section including a first elongate element and a second elongate element; providing a first tubular graft element having a first end and a second end; cutting the first tubular graft element and folding the first tubular graft element to define a fold region, wherein the first leg is defined between the first end of the first tubular graft element and the fold region and wherein the second leg is defined between the second end of the first tubular graft element and the fold region, wherein an excess portion of the fold region between the first and second legs defines a tab extending away from an uncut region of the excess portion; applying the first tubular graft element over the second section such that the second elongate element extends through the second leg of the first tubular graft element and out of the second end of the first tubular graft element, and such that the fold region is situated between the first and second legs to define the bifurcation; forming a trunk portion of the endoprosthesis along the mandrel such that the trunk portion extends along a portion of the first section of the mandrel and the tab lays against a section of the trunk portion; and securing together the trunk portion and the first tubular graft element to form the endoprosthesis.
2. 2 . The method of claim 1 , wherein the trunk portion is formed as a second tubular graft element that is thereafter applied over the first section of the mandrel and secured to the first tubular graft element.
3. 3 . The method of claim 1 , further comprising applying a graft material to an exterior of the endoprosthesis such that the graft material extends along at least a portion of the first and second legs to maintain an alignment of the first and second legs.
4. 4 . The method of claim 1 , wherein a longitudinal axis of the first leg is parallel with a longitudinal axis of the second leg.
5. 5 . The method of claim 1 , further comprising applying a support structure to the endoprosthesis along the trunk portion.
6. 6 . The method of claim 5 , wherein the support structure is a stent.
7. 7 . The method of claim 5 , wherein the support structure is situated between the trunk portion and a graft material surrounding the trunk portion.
8. 8 . The method of claim 1 , further comprising applying a support structure to the endoprosthesis along one or more of the first and second legs.
9. 9 . The method of claim 8 , wherein the support structure is a stent.
10. 10 . The method of claim 8 , wherein the support structure is situated between the first tubular graft element and a graft material surrounding the first tubular graft element.
11. 11 . The method of claim 1 , wherein the first tubular graft element is applied over the second section such that the first elongate element extends through the first leg of the first tubular graft element and out of the first end of the first tubular graft element.
12. 12 . The method of claim 1 , wherein the tab extends between the first and second elongate elements.
13. 13 . A method of manufacturing an endoprosthesis that includes a first leg, a second leg, and a bifurcation, the method comprising: providing a mandrel having a first section and a second section, the second section including a first elongate element and a second elongate element; providing a first tubular graft element having a first end and a second end; folding the first tubular graft element to define a fold region, wherein the first leg is defined between the first end of the first tubular graft element and the fold region and wherein the second leg is defined between the second end of the first tubular graft element and the fold region; applying the first tubular graft element over the second section such that the second elongate element extends through the second leg of the first tubular graft element and out of the second end of the first tubular graft element, and such that the fold region is situated between the first and second legs to define the bifurcation; forming a trunk portion of the endoprosthesis along the mandrel such that the trunk portion extends along a portion of the first section of the mandrel, the trunk portion including a tab that extends across the bifurcation of the first tubular graft element; and securing together the trunk portion and the first tubular graft element to form the endoprosthesis, wherein a first cut line is defined about a circumference of the first tubular graft element in a first region between the first and second ends, the first tubular graft element being incised along the first cut line about a portion of less than an entirety of the first cut line define a first incised portion and a first unincised portion, and the first tubular graft element is folded along the first unincised portion to define the fold region.
14. 14 . A method of manufacturing an endoprosthesis that includes a first leg, a second leg, and a bifurcation, the method comprising: providing a mandrel having a first section and a second section, the second section including a first elongate element and a second elongate element; providing a first tubular graft element having a first end and a second end; folding the first tubular graft element to define a fold region, wherein the first leg is defined between the first end of the first tubular graft element and the fold region and wherein the second leg is defined between the second end of the first tubular graft element and the fold region; applying the first tubular graft element over the second section such that the second elongate element extends through the second leg of the first tubular graft element and out of the second end of the first tubular graft element, and such that the fold region is situated between the first and second legs to define the bifurcation; forming a trunk portion of the endoprosthesis along the mandrel such that the trunk portion extends along a portion of the first section of the mandrel, the trunk portion including a tab that extends across the bifurcation of the first tubular graft element; and securing together the trunk portion and the first tubular graft element to form the endoprosthesis, wherein a first cut line is defined about a circumference of the first tubular graft element in a first region between the first and second ends, the first tubular graft element being incised along the first cut line about a portion of less than an entirety of the first cut line define a first incised portion and a first unincised portion, a second cut line is defined about the circumference of the first tubular graft element in a second region between the first and second ends that is longitudinally offset from the first region, the first tubular graft element being incised along the second cut line about a portion of less than an entirety of the second cut line to define a second incised portion and a second unincised portion, and a third cut line extends between the first and second cut lines, the first tubular graft element being incised along the third cut line.
15. 15 . The method of claim 14 , further comprising folding the first tubular graft element along the second unincised portion, the fold region including the folded first unincised portion and the folded second unincised portion.
16. 16 . The method of claim 14 , wherein the first tubular graft element is applied over the second section such that the fold region extends between the first and second legs to define the bifurcation.
17. 17 . The method of claim 14 , wherein an excess section is defined in a region bound between the first and second cut lines, and wherein the third cut line bisects the excess section, and wherein the first tubular graft element is applied over the second section such that at least a portion of the excess section extends along the first section of the mandrel away from the bifurcation.
18. 18 . The method of claim 17 , wherein the portion of the excess section that extends along the first section of the mandrel includes a first flap and a second flap opposite the first flap, wherein free ends of each of the first and second flaps are defined by the third cut line.
19. 19 . A method of constructing a multi-lumen graft device having a main graft body and at least two graft legs, the method comprising: providing a mandrel with a main mandrel body and at least two mandrel legs; applying over the mandrel a single tubular structure that overlays each of the two mandrel legs and includes at least one tab that overlaps at least a portion of the main mandrel body; forming the main graft body over the main mandrel body, the main graft body bonded to the at least one tab and positioned to overlap at least a portion of both of the two graft legs; and forming the two graft legs by partially cutting and folding the single tubular structure, with an uncut portion of the single tubular structure extending therebetween, the at least one tab extending away from the uncut portion such that the at least one tab lays against a section of the mandrel.
20. 20 . The method of claim 19 , wherein at least one stent element is attached to the graft device.

Description

CROSS-REFERENCE TO RELATED APPLICATION This application is a national phase application of PCT Application No. PCT/US2020/017219, internationally filed on Feb. 7, 2020, which is herein incorporated by reference in its entirety for all purposes. FIELD The present disclosure relates to systems and methods of manufacture for branched vascular endoprosthetic systems. BACKGROUND There is a need for advanced devices, tools, systems and methods used for the endoluminal treatment of vascular diseases in regions of branch vessels and main vessel junctions, including diseases affecting the aorta, including the descending aorta, the internal and external iliac arteries, and the femoral arteries. SUMMARY Various examples related to endoprosthesis and associated methods of manufacturing the endoprosthesis are disclosed. Various disclosed concepts relate to the endoprosthesis having a first leg, a second leg, and a bifurcation. According to one example (“Example 1”), the method of manufacturing includes providing a mandrel having a first section and a second section, the second section including a first elongate element and a second elongate element. The method also includes providing a first tubular graft element having a first end and a second end. The method also includes folding the first tubular graft element to define a fold region. The first leg is defined between the first end of the first tubular graft and the fold region, and the second leg is defined between the second end of the first tubular graft element and the fold region. The method also includes applying the first tubular graft over the second section such that the second elongate element extends through the second leg of the first tubular graft and out of the second end of the first tubular graft, and such that the fold region is situated between the first and second legs to define the bifurcation. The method also includes forming a trunk portion of the endoprosthesis along the mandrel such that the trunk portion extends along a portion of the first section of the mandrel. The trunk portion including a tab that extends across the bifurcation of the first tubular graft element. The method also includes securing together the trunk portion and the first tubular graft element to form the endoprosthesis. According to another example further to Example 1 (“Example 2”), the trunk portion is formed as a second tubular graft element that is thereafter applied over the first section of the mandrel and secured to the first tubular graft element. According to another example further to Example 1 or 2 (“Example 3”), the method also includes applying a graft material to an exterior of the endoprosthesis such that the graft material extends along at least a portion of the first and second legs to maintain an alignment of the first and second legs. According to another example further to any preceding Example (“Example 4”), a longitudinal axis of the first leg is parallel with a longitudinal axis of the second leg. According to another example further to any preceding Example (“Example 5”), a first cut line is defined about a circumference of the tubular graft in a first region between the first and second ends. The graft element is incised along the first cut line about a portion of less than an entirety of the first cut line define a first incised portion and a first unincised portion. According to another example further to Example 5 (“Example 6”), the first tubular graft element is folded along the first unincised portion to define the fold region. According to another example further to Example 5 or 6 (“Example 7”), a second cut line is defined about a circumference of the tubular graft in a second region between the first and second ends that is longitudinally offset from the first region. The graft element is incised along the second cut line about a portion of less than an entirety of the second cut line to define a second incised portion and a second unincised portion. A third cut line extends between the first and second cut lines, the graft element being incised along the third cut line. According to another example further to Example 7 (“Example 8”), the method also includes folding the first tubular graft element along the second unincised portion, the fold region including the folded first unincised portion and the folded second unincised portion. According to another example further to Example 7 or 8 (“Example 9”), the first tubular graft is applied over the second section such that the fold portion extends between the first and second legs to define the bifurcation. According to another example further to any one of Examples 7 to 9 (“Example 10”), an excess section is defined in a region bound between the first and second cut lines. The third cut line bisects the excess section. The first tubular graft is applied over the second section such that at least a portion of the excess section extends along the first portion of the mandrel away from the bifur