Apparatus and methods for grafting blood vessel tissue

• US 6,117,166 A
• Filed: 10/27/1997
• Issued: 09/12/2000
• Est. Priority Date: 10/27/1997
• Status: Expired due to Fees

• Current Assignee: Neet, John M., Winston, Thomas R.
• Original Assignee: Neet, John M., Winston, Thomas R.
• Inventors: Winston, Thomas R., Neet, John M.
• Primary Examiner(s): Willse, David H.
• Assistant Examiner(s): GHERBI, SUZETTE JAIME J
• Application Number:
  US08/958,179
• Time in Patent Office: 1,051 Days
• Field of Search: 623/11, 623/1, 623/12, 623/1.13, 623/1.41
• US Class Current: 623/1.13
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/92 Stents in the form of a rolled-up sheet expanding after insertion into the vessel , e.g. with a spiral shape in cross-section
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• 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

Abstract

Apparatus and methods especially useful for facilitating grafting of healthy blood vessel tissue onto the internal wall of a blood vessel are described. In one embodiment, the apparatus includes a vascular graft secured to an expandable, wire mesh endovascular stent. The vascular graft is a partial thickness section taken through the thickness of the graft donor tissue and includes the intimal layer composed of endothelial cells. The partial thickness section facilitates regeneration of an endothelial cell layer. The vascular graft may be an autograft or homograft, and may have been prepared earlier and cryogenically frozen. The combination of stent and vascular graft is inserted into a blood vessel having damage to an internal wall. The stent is expanded in position at the site of damage, and the vascular graft grafts onto the damaged internal wall of the blood vessel while being supported by the stent. The stent also provides structural support for the blood vessel wall. The stent may be expanded with a balloon catheter inserted through the lumen of the stent. Alternate embodiments employ a variety of expandable and self-expanding endovascular stents.

Claims

1. Apparatus comprising:

an endovascular stent; and

a vascular graft comprising a first partial thickness section of a full thickness of blood vessel tissue, the blood vessel tissue having an intimal layer, a medial layer and an adventitial layer, wherein said first partial thickness section comprises at least a portion of the intimal layer wherein at least a portion of the adventitial layer has been removed and a second partial thickness section includes at least a portion of the adventitial layer, said vascular graft positioned against said endovascular stent.

2. Apparatus in accordance with claim 1 wherein said first partial thickness section further comprises at least a portion of the adventitial layer.

3. Apparatus in accordance with claim 1 wherein said endovascular stent comprises an expandable wire mesh stent.

4. Apparatus in accordance with claim 1 wherein said endovascular stent is expandable and comprises a thin flexible sheet having perforations therethrough.

5. Apparatus in accordance with claim 1 wherein said vascular graft comprises meshed tissue.

6. Apparatus in accordance with claim 1 wherein said vascular graft comprises a plurality of strips of blood vessel tissue.

7. Apparatus in accordance with claim 1 wherein said vascular graft comprises autograft tissue.

8. Apparatus in accordance with claim 7 wherein said vascular graft comprises arterial tissue.

9. Apparatus in accordance with claim 7 wherein said vascular graft comprises venous tissue.

10. Apparatus in accordance with claim 1 wherein said vascular graft comprises homograft tissue.

11. Apparatus in accordance with claim 10 wherein said vascular graft has been cryogenically frozen.

12. Apparatus in accordance with claim 1 further comprising a plurality of surgical sutures securing said vascular graft to said endovascular stent.

13. Apparatus in accordance with claim 1 further comprising a plurality of surgical staples securing said vascular graft to said endovascular stent.

14. Apparatus in accordance with claim 1 wherein said endovascular stent is a balloon-expandable stent having a lumen.

15. Apparatus in accordance with claim 14 further comprising a balloon catheter inserted through the lumen of said balloon-expandable stent.

16. Apparatus in accordance with claim 1 wherein said stent is a self-expanding roll type stent.

17. A method comprising the steps of:

obtaining a tubular section of blood vessel;

making a longitudinal cut through a wall of the tubular section forming a sheet of full thickness blood vessel tissue having an intimal layer, a medial layer and an adventitial layer;

forming a first partial thickness section and a second partial thickness section, wherein the first partial thickness section comprises at least a portion of the intimal layer, the first partial thickness section forming a vascular graft wherein at least a portion of the adventitial layer has been removed;

positioning the vascular graft against an expandable endovascular stent; and

securing the vascular graft to the endovascular stent.

18. A method in accordance with claim 17 wherein forming the first partial thickness section comprises the step of forming a second partial thickness section including at least a portion of the adventitial layer.

19. A method in accordance with claim 17 further comprising the step of securing the vascular graft to the endovascular stent using surgical sutures.

20. A method in accordance with claim 17 further comprising the step of securing the vascular graft to the endovascular stent using surgical staples.

21. A method in accordance with claim 17 wherein forming the first partial thickness section comprises the step of forming a solid sheet from the first partial thickness section.

22. A method in accordance with claim 17 further comprising the step of forming a mesh from the first partial thickness section.

23. A method in accordance with claim 17 further comprising the step of forming a plurality of strips from the first partial thickness section of blood vessel tissue.

24. A method in accordance with claim 17, further comprising the steps of:

inserting the endovascular stent in combination with the vascular graft into a blood vessel having an internal wall; and

expanding the stent so that the vascular graft grafts to the internal wall of the blood vessel.

25. A method in accordance with claim 24 wherein providing a stent comprises the step of providing a balloon expandable stent and wherein expanding the stent comprises the step of expanding the balloon expandable stent to support the vascular graft against the internal wall of the blood vessel.

26. A method in accordance with claim 24 wherein providing a stent comprises the step of providing a self-expanding roll type stent and wherein expanding the stent comprises the step of allowing the self-expanding roll type stent to expand and to press the vascular graft against the internal wall of the blood vessel.