ENDOLUMINAL PROSTHESIS WITH STEERABLE BRANCH

• US 20130079870A1
• Filed: 09/25/2012
• Published: 03/28/2013
• Est. Priority Date: 09/27/2011
• Status: Active Grant

• Current Assignee: Cleveland Clinic Foundation, Cook Medical Technologies, LLC (Cook Group Incorporated)
• Original Assignee: Cleveland Clinic Foundation, Cook Medical Technologies, LLC (Cook Group Incorporated)
• Inventors: Roeder, Blayne A., Greenberg, Roy K., Kratzberg, Jarin, Huser, Matthew S.
• Granted Patent: US 9,662,196 B2
• Time in Patent Office: Days
• US Class Current: 623/1.35
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/89 the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/954 for placing stents or stent-grafts in a bifurcation
• CPC Class Codes: A61F 2002/061 provided with means for allowing access to secondary lumens
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2002/9511 the retaining means being filaments or wires
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2220/0025 Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2220/0033 made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0066 stapled
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0006 circular
• CPC Class Codes: A61F 2230/0008 elliptical or oval
• CPC Class Codes: A61F 2250/0006 for adjusting angular orientation
• CPC Class Codes: A61F 2250/0018 differing in elasticity, stiffness or compressibility
• CPC Class Codes: A61F 2250/0029 differing in bending or flexure capacity
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61F 2250/0065 telescopic
• CPC Class Codes: A61F 2250/0067 : Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61F 2250/0098 : radio-opaque, e.g. radio-opaque markers

Abstract

An endoluminal prosthesis may include a tubular main graft body including a sidewall and proximal and distal ends. A first stent may be positioned near the proximal end of the main graft body. A second stent may be positioned adjacent to and distal of the first stent. An opening in the sidewall may be positioned longitudinally between a peak of the first stent and a valley of the second stent. A tubular branch may be disposed in the opening. The branch may include first and second end openings. The branch may be flexibly orientable between a retrograde configuration in which the first end opening is oriented toward the distal end and the second end opening is oriented toward the proximal end and an antegrade configuration in which the first end opening is oriented toward the proximal end and the second end opening is oriented toward the distal end.

Claims

1. An endoluminal prosthesis comprising a tubular main graft body, the main graft body comprising:

a sidewall, a proximal end, and a distal end;

a first stent positioned near the proximal end of the main graft body, and a second stent positioned adjacent to and distal of the first stent, each of the first stent and the second stent comprising a peak and a valley;

an opening in the sidewall positioned longitudinally between the peak of the first stent and the valley of the second stent; and

a tubular branch disposed in the opening and attached to the main graft body, the branch comprising a first end opening and a second end opening, the branch being flexibly orientable between a retrograde configuration and an antegrade configuration, wherein, in the retrograde configuration, the first end opening is oriented toward the distal end of the main graft body and the second end opening is oriented toward the proximal end of the main graft body, and, in the antegrade configuration, the first end opening is oriented toward the proximal end of the main graft body and the second end opening is oriented toward the distal end of the main graft body.

2. The prosthesis of claim 1, wherein the opening in the sidewall comprises a slit extending at least partially circumferentially around the main graft body, the branch comprises a first portion extending inward from the sidewall, a second portion extending outward from the sidewall, and an intermediate portion attached to the sidewall.

3. The prosthesis of claim 2, wherein the slit comprises a length of between about ⅖

of a circumference of the branch and about ½

of the circumference of the branch.

4. The prosthesis of claim 1, wherein the sidewall comprises a deformable graft region and an at least partially supported perimeter about the deformable graft region, the deformable graft region disposed between the first stent and the second stent and free of any stenting within the deformable graft region, wherein the opening in the sidewall is positioned within the deformable graft region, and the branch extends outward from the deformable graft region,

5. The prosthesis of claim 1, wherein the branch further comprises a biocompatible graft material and a support structure attached to the biocompatible graft material of the branch, and the support structure of the branch comprises at least one of a Z-stent, a helical stent, or an annular ring.

6. The prosthesis of claim 1, wherein the branch is spaced from the proximal end of the prosthesis by a distance of between about 5 mm and about 30 mm.

7. The prosthesis of claim 1, wherein the branch is positioned longitudinally at least partially between the peak of the first stent and the valley of the first stent and circumferentially between adjacent struts of the first stent.

8. The prosthesis of claim 1, wherein the first stent is attached to an inner surface of the main graft body, the peak of the first stent comprises a series of peaks, one of the series of peaks comprises a widened peak comprising a greater angle than an adjacent peak, and the widened peak is circumferentially aligned with the branch.

9. The prosthesis of claim 1, further comprising a third stent positioned near the proximal end of the main graft body, wherein the first stent is attached to an inner surface of the main graft body, the third stent is attached to an outer surface of the main graft body and comprises a series of peaks, the third stent at least partially overlaps the first stent, a first peak of the third stent is circumferentially aligned with each of the branch and the peak of the first stent, and a second peak of the third stent is circumferentially aligned with the valley of the first stent.

10. The prosthesis of claim 1, further comprising a third stent positioned near the proximal end of the main graft body, wherein each of the first stent and the third stent is attached to a surface of the main graft body, the peak of the first stent comprises a series of peaks, the valley of the first stent comprises a series of valleys, the third stent comprises a series of peaks and a series of valleys, the third stent comprises a shorter amplitude than the first stent and a greater number of peaks and valleys than the first stent, the third stent is positioned proximal of the first stent, and the first stent and the third stent are in a nested relationship with one another.

11. The prosthesis of claim 1, further comprising a third stent positioned near the proximal end of the main graft body, the first stent comprising a larger cross sectional area than the third stent.

12. The prosthesis of claim 1, wherein the proximal end of the main graft body comprises a slanted end, and a top longitudinal length of the main graft body is longer than a bottom longitudinal length of the main graft body to form the slanted end.

13. The prosthesis of claim 1, wherein the first stent is attached to an inner surface of the main graft body, the peak of the first stent comprises a series of peaks, one of the series of peaks comprises a widened peak comprising a greater angle than an adjacent peak, and the widened peak is circumferentially aligned with the branch;

wherein the opening in the sidewall comprises a slit positioned longitudinally between the widened peak and the valley of the first stent, extending at least partially circumferentially around the main graft body between adjacent struts of the first stent, and comprising a length of between about ⅖

of a circumference of the branch and about ½

of the circumference of the branch;

wherein the branch comprises a first portion extending inward from the sidewall, a second portion extending outward from the sidewall, an intermediate portion attached to the sidewall, a biocompatible graft material, and a support structure attached to the biocompatible graft material of the branch and comprising at least one of a Z-stent, a helical stent, or an annular ring.

14. The prosthesis of claim 1, further comprising a catheter extending within each of the main graft body and the branch in a preloaded configuration, wherein the catheter extends through a distal end opening of the main graft body and within the branch for retrograde delivery of the prosthesis.

15. The prosthesis of claim 1, further comprising a catheter extending within each of the main graft body and the branch in a preloaded configuration, wherein the catheter extends through a proximal end opening of the main graft body and within the branch for antegrade delivery of the prosthesis.

16. An endoluminal prosthesis comprising:

a tubular main graft body, the main graft body comprising;

a proximal end and a distal end;

a slit in the main graft body, the slit extending at least partially circumferentially around the main graft body; and

a tubular branch disposed in the slit and comprising a first portion extending inward from the main graft body, a second portion extending outward from the main graft body, and an intermediate portion attached to the main graft body adjacent to the slit;

wherein the second portion of the branch is flexibly orientable toward the proximal end or the distal end of the main graft body.

17. The prosthesis of claim 16, wherein the slit comprises a length of between about ⅖

of a circumference of the branch and about ½

of the circumference of the branch.

18. The prosthesis of claim 16, further comprising a stent positioned near the proximal end of the main graft body, wherein the slit is positioned longitudinally between a peak and a valley of the stent and circumferentially between adjacent struts of the stent.

19. The prosthesis of claim 16, further comprising a stent attached to the main graft body and comprising a peak and a valley, wherein the peak of the stent is spaced from the proximal end of the main graft body by a distance of less than about 2 mm, and the branch is spaced from the proximal end of the main graft body by a distance of between about 5 mm and about 30 mm.

20. A method of treating a body vessel, the method comprising:

introducing an endoluminal prosthesis into the body vessel, the prosthesis comprising a tubular main graft body comprising;

a sidewall, a proximal end, and a distal end;

an opening in the sidewall of the main graft body; and

a tubular branch disposed in the opening and attached to the main graft body, the branch comprising a first end opening and a second end opening, the first end opening being flexibly orientable toward the proximal end or the distal end of the main graft body;

introducing a balloon into the branch to move the branch into a desired orientation relative to the graft body; and

deploying a branch prosthesis within the branch in the desired orientation to connect the prosthesis to a branch vessel.