Stent graft with internal tunnels and fenestrations and methods of use

• US 10,390,932 B2
• Filed: 04/04/2017
• Issued: 08/27/2019
• Est. Priority Date: 04/05/2016
• Status: Active Grant

• Current Assignee: Bolton Medical, Inc. (Terumo Corporation)
• Original Assignee: Bolton Medical, Inc. (Terumo Corporation)
• Inventors: Lostetter, Timothy
• Primary Examiner(s): Stewart, Alvin J
• Application Number:
  US15/478,737
• Publication Number:
  US 20170281332A1
• Time in Patent Office: 875 Days
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2002/061 provided with means for allowing access to secondary lumens
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/005 using adhesives
• 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 2250/0026 differing in surface structures
• CPC Class Codes: A61F 2250/0039 differing in diameter

Abstract

A thoraco-abdominal branch graft prosthesis includes a lumen main graft component that defines a lumen and at least one main graft wall fenestration. At least one tunnel graft component of the branch graft prosthesis defines at least one tunnel graft fenestration. The tunnel graft component is within the main graft lumen defined by the luminal main graft component. A luminal wall of the tunnel graft component is fixed to the luminal wall of the main graft component. The fenestration of the tunnel graft wall is aligned with the fenestration of the main graft wall. The thoraco-abdominal branch graft prosthesis can be implanted in a patient at a site of a thoraco-abdominal aneurysm.

Claims

1. A thoraco-abdominal branch graft prosthesis, comprising:

a) a main graft component having a luminal wall defining an open proximal end, an open distal end opposite the open proximal end, a main lumen extending from the open proximal end to the open distal end, and at least one main graft wall fenestration; and

b) at least one tunnel graft component having a tunnel graft luminal wall defining, at least in part, an open tunnel graft proximal end, an open tunnel graft distal end opposite the open tunnel graft proximal end, a tunnel graft lumen extending from the open tunnel graft proximal end to the open tunnel graft distal end, and at least one tunnel graft fenestration in the tunnel graft wall, wherein the tunnel graft component is within the main graft lumen and a major longitudinal axis of the tunnel graft lumen that is parallel to and spaced apart from a major longitudinal axis of the main lumen, and wherein the wall of the tunnel graft component is fixed to the wall of the main graft component, whereby the fenestration of the tunnel graft wall is aligned with the fenestration of the luminal wall.

2. The thoraco-abdominal branch graft prosthesis of claim 1, wherein the open tunnel graft proximal end, the open tunnel graft distal end, and the tunnel graft lumen are defined in-part by the main graft component.

3. The thoraco-abdominal branch graft prosthesis of claim 1, wherein the wall of the tunnel graft component is sutured to the wall of the main graft component at the fenestration of the tunnel graft component and at the fenestration of the main graft component, whereby the fenestrations together define a single fenestration.

4. The thoraco-abdominal branch graft prosthesis of claim 3, including at least two tunnel graft components.

5. The thoraco-abdominal branch graft prosthesis of claim 4, including three tunnel graft components.

6. The thoraco-abdominal branch graft prosthesis of claim 5, wherein two of the tunnel graft components are located essentially opposite each other within the lumen of the main graft component, and wherein fenestrations of the two tunnel graft components are located at about the same distance from the open proximal end of the main graft component.

7. The thoraco-abdominal branch graft prosthesis of claim 6, wherein the third tunnel graft component is at a portion of the main graft component wall that is between the other two tunnel grafts, and wherein an open proximal end of the third tunnel graft is proximal to the open proximal end of the other tunnel graft components.

8. The thoraco-abdominal branch graft prosthesis of claim 7, wherein third tunnel graft component defines two wall apertures that are aligned along a major longitudinal axis of the third tunnel graft component, and wherein the main graft wall defines wall apertures that are aligned with apertures of the wall of the third tunnel graft.

9. The thoraco-abdominal branch graft prosthesis of claim 8, further including a bare stent extending proximally from the open proximal end of the main graft component.

10. The thoraco-abdominal branch graft prosthesis of claim 9, wherein the bare stent includes angled struts that define proximal apices and distal apices.

11. The thoraco-abdominal branch graft prosthesis of claim 10, wherein the bare stent includes barbs proximate to or at the proximal apices of the bare stent.

12. The thoraco-abdominal branch graft prosthesis of claim 11, wherein at least one of the main graft component and the tunnel graft components include stents at the respective open proximal ends and open distal ends.

13. The thoraco-abdominal branch graft prosthesis of claim 12, wherein the main graft component is bifurcated at the open distal end, thereby defining two legs of the prosthesis.

14. The thoraco-abdominal branch graft prosthesis of claim 13, wherein the open distal end of one of the legs of the main graft component is distal to the other.

15. The thoraco-abdominal branch graft prosthesis of claim 14, further including at least one branch prosthesis extending from within the tunnel graft through the wall fenestration of the tunnel graft that is aligned with the wall fenestration of the tunnel graft.

16. The thoraco-abdominal branch graft prosthesis of claim 15, wherein the at least one branch prosthesis defines an open end that is in fluid communication with the open distal end of the tunnel graft within which it extends.

17. The thoraco-abdominal branch graft prosthesis of claim 15, wherein the at least one branch prosthesis defines an open end that is in fluid communication with the open proximal end of the tunnel graft within which it extends.

18. The thoraco-abdominal branch graft prosthesis of claim 1, wherein the luminal wall of main graft component defines a midsection cross-sectional diameter of the main lumen that is smaller than at least one of the open proximal end and the open distal end of the main graft component.

19. The thoraco-abdominal branch graft prosthesis of claim 18, wherein the cross-sectional diameter of the mid-section is smaller than both the open proximal end and the open distal end of the main graft component.

20. The thoraco-abdominal branch graft prosthesis of claim 18, wherein one of the open proximal end and the open distal end of the at least one tunnel graft is sutured to the main graft component.

21. The method of claim 20, wherein at one of the open proximal end and the open distal end of the at least one tunnel graft is secured to the main graft component, and wherein the wall of the tunnel graft component is fixed to the wall of the main graft component.

22. A method of implanting a thoraco-abdominal branch graft prosthesis, comprising the steps of:

a) delivering a thoraco-abdominal branch graft prosthesis through a blood vessel to a thoraco-abdominal aneurysm site in a patient, the thoraco-abdominal branch graft prosthesis including

i) a main graft component having a luminal wall defining, at least in part, an open proximal end, an open distal end opposite the open proximal end, a main lumen extending from the open proximal end to the open distal end, and at least one main graft wall fenestration; and

ii) at least one tunnel graft component having a wall defining an open proximal end, an open distal end opposite the open proximal end, a lumen extending from the tunnel graft proximal end to the tunnel graft distal end, and at least one tunnel graft fenestration in the tunnel graft wall, wherein the tunnel graft component is within the main graft lumen and a major longitudinal axis of the tunnel graft lumen that is parallel to and spaced apart from a major longitudinal axis of the main lumen, and wherein the wall of the tunnel graft component is fixed to the wall of the main graft component, whereby the fenestration of the tunnel graft wall is aligned with the fenestration of the main graft wall,

wherein the at least one main graft wall fenestration is substantially aligned with at least one branch vessel of the patient at the thoraco-abdominal aneurysm site;

b) inserting at least one branch prosthesis through the at least one main graft wall fenestration and the at least one tunnel graft fenestration within the lumen of the at least one tunnel graft component, the at least one branch prosthesis having an open distal end and an open proximal end; and

c) inserting one of the distal end or the proximal end of the at least one branch prosthesis into at least one branch vessel of the patient at the thoraco-abdominal aneurysm site.

23. The method of claim 22, wherein the thoraco-abdominal branch graft prosthesis is a bifurcated thoraco-abdominal branch graft prosthesis.

24. The method of claim 23, wherein the at least one branch prosthesis is inserted through the at least one main graft wall fenestration and at least one tunnel graft fenestration from within at least one tunnel graft by an access point cranial to the thoraco-abdominal aneurysm site of the patient.

25. The method of claim 24, wherein the at least one branch prosthesis is inserted through the at least one main graft wall fenestration and at least one tunnel graft fenestration to within at least one tunnel graft by an access point caudal to the thoraco-abdominal aneurysm site of the patient.

26. The method of claim 22, wherein the luminal wall of the main graft component defines a midsection cross-sectional diameter of the main lumen that is smaller than at least one of the open proximal end and the open distal end of the main graft component.