Method and apparatus for balloon expandable stent-graft delivery

• US 5,522,882 A
• Filed: 10/21/1994
• Issued: 06/04/1996
• Est. Priority Date: 10/21/1994
• Status: Expired due to Term

• Current Assignee: Bard Peripheral Vascular Incorporated (Becton, Dickinson & Co)
• Original Assignee: IMPRA Incorporated (Becton, Dickinson & Co)
• Inventors: Gaterud, Mark T., Khalilifard, Fariba, Banas, Christopher E., Kowligi, Rajagopal R.
• Primary Examiner(s): Jones, Mary Beth
• Assistant Examiner(s): SNOW, BRUCE EDWARD
• Application Number:
  US08/327,195
• Time in Patent Office: 592 Days
• Field of Search: 623/1, 623/11, 606/192, 606/194, 606/195, 606/198, 606/108
• US Class Current: 623/1.11
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2002/072 Encapsulated stents, e.g. wire or whole stent embedded in lining
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2002/9534 for repositioning of stents

Abstract

A stent-graft delivery system which includes a catheter, an expandable balloon having non-tapered ends positioned near the distal end of the catheter, a stent circumferentially positioned around a center of the balloon, and a graft circumferentially positioned around the stent. The balloon configuration comprising non-tapered ends may be achieved by 1) preforming the balloon to the desired geometry which comprises substantially non-tapered ends; 2) positioning a non-compliant sheath over each of the ends of an existing balloon having tapered ends, or 3) invertedly attaching the first and second ends of a compliant tubular member to the catheter to form the desired balloon configuration. The desired balloon configuration is a balloon geometry which uniformly conforms to the geometry of the stent-graft assembly. A method for introducing the stent-graft delivery system into a blood vessel are also disclosed. The method includes inserting the stent-graft delivery system into the blood vessel, guiding the stent-graft assembly to the desired site, inflating the balloon of the balloon catheter, deflating the balloon, and withdrawing the catheter and expandable balloon. The stent-graft delivery systems are also suitable for introducing and delivering stents without grafts.

Claims

1. A balloon expandable stent-gaff delivery system comprising:

a) a catheter having proximal and distal ends thereof;

b) an expandable balloon attached near the distal end of said catheter wherein said balloon comprises an interior surface, an exterior surface, and first and second ends, said first and second ends being substantially non-tapered upon expansion of said balloon from a first unexpanded diameter to a second larger diameter;

c) a stent having an interior surface, an exterior surface, and first and second ends thereof wherein said stent is positioned around said expandable balloon;

d) a graft having an interior surface, an exterior surface, and first and second ends thereof wherein said graft is positioned around said stent such that said stent is concentrically contained within said graft; and

(e) a substantially non-compliant sheath positioned over each of said first and second ends of said expandable balloon, wherein each of said sheaths is positioned adjacent to one of said first and second ends of said stent, respectively, without overlapping onto or underlying any region of said stent.

2. The balloon expandable stent-graft delivery system of claim 1 wherein said balloon is substantially parallel along its longitudinal axis upon expansion.

3. The balloon expandable stent-graft delivery system of claim 1 wherein the exterior surface of said balloon in its expanded state is substantially parallel in length along the entire interior surface of the graft.

4. The balloon expandable stent-graft delivery system of claim 1 wherein said sheaths are substantially non-compliant.

5. The balloon expandable stent-graft delivery system of claim 1 wherein said expandable balloon, in said balloon'"'"'s expanded state, and said stent are equal in length.

6. The balloon expandable stent-graft delivery system of claim 1 wherein said graft and said stent are equal in length.

7. The balloon expandable stent-graft delivery system of claim 1 wherein said stent is equal to or shorter than a length of said expandable balloon.

8. The balloon expandable stent-graft delivery system of claim 1 wherein said non-tapered first and second ends of said expandable balloon are invertedly attached to said catheter.

9. The balloon expandable stent-graft delivery system of claim 8 wherein said expandable balloon, in said balloon'"'"'s expanded state, and said stent are equal in length.

10. A balloon expandable stent-graft delivery system comprising:

a) a catheter having proximal and distal ends thereof and an expandable balloon attached near the distal end of said catheter wherein said expandable balloon has proximal and distal ends thereof and is capable of being expanded from a first unexpanded diameter to a second larger diameter;

b) a stent having first and second ends wherein said stent is positioned around said expandable balloon;

c) a graft positioned around said stent such that said stent is concentrically contained within said graft;

d) a first substantially radially non-compliant sheath positioned over a distal end of the expandable balloon laterally adjacent and positionally fixed relative to a first of said stent when said expandable balloon is in its first unexpanded diameter and in its second expanded diameter and;

e) a second substantially radially non-compliant sheath positioned over a proximal end of the expandable balloon and laterally adjacent to a second end of said stent when said expandable balloon is in its first unexpanded diameter and in its second expanded diameter.

11. The balloon expandable stent-graft delivery system of claim 10 wherein said stent is equal to or shorter than a length of said expandable balloon.

12. The balloon expandable stent-graft delivery system of claim 10 wherein said graft is a vascular graft comprising expanded polytetrafluoroethylene.

13. The balloon expandable stent-graft delivery system of claim 10 wherein said first and second substantially non-compliant sheaths each further comprise at least one of a heat shrinkable tubing, a metal tubing, a plastic tubing, and a restraining wrap.

14. The balloon expandable stent-graft delivery system of claim 10 wherein second substantially non-compliant sheath extends along a length of said catheter to the proximal end of said catheter such that it is slidably manipulative along said length of said catheter.

15. A balloon expandable stent-graft delivery system comprising:

a) a catheter having proximal and distal ends thereof,

b) an expandable balloon attached near the distal end of said catheter wherein said balloon has first and second ends and at least one of said ends is preformed to configure a non-tapered end;

c) a stent having an interior surface, an exterior surface, and first and second ends thereof wherein said stent is positioned around said expandable balloon;

d) a graft having an interior surface, an exterior surface, and first and second ends thereof wherein said graft is positioned around said stent such that said stent is concentrically contained within said graft; and

(e) at least one substantially non-compliant sheath positioned over the non-preformed end of said expandable balloon such that said sheath is adjacent to one end of said stent without overlapping onto said stent, whereby radial expansion of the non-preformed end of the expandable balloon is constrained by the at least one substantially non-compliant sheath.

16. The balloon expandable stent-graft delivery system of claim 15 wherein said at least one sheath is affixed to said catheter.

17. The balloon expandable stent-graft delivery system of claim 15 wherein said sheath extends along a length of said catheter to the proximal end of said catheter such that it is slidably manipulative along said length of said catheter.

18. A method for introducing a stent-graft assembly into a blood vessel comprising the steps of:

a) providing a balloon expandable stent-graft delivery system comprising;

a catheter having proximal and distal ends thereof;

an expandable balloon attached near the distal end of said catheter wherein said balloon comprises an interior surface, an exterior surface, and first and second ends, said first and second ends being substantially non-tapered upon expansion of said balloon from a first unexpanded diameter to a second larger diameter;

a stent having an interior surface, an exterior surface, and first and second ends thereof wherein said stent is positioned around said expandable balloon;

a graft having an interior surface, an exterior surface, and first and second ends thereof wherein said graft is positioned around said stent such that said stent is concentrically contained within said graft; and

a substantially non-compliant sheath positioned over each of the first and second ends of said balloon such that each of the sheaths are adjacent to one of the first and second ends of the stent;

b) inserting the balloon expandable stent-graft delivery system into the blood vessel;

c) guiding the stent-graft assembly to a desired site;

d) radially expanding a mid-portion of the expandable balloon to the second larger diameter while constraining at least one of the first and second ends of the balloon from radially expanding with the at least one substantially non-complaint sheath to seat the stent-graft assembly within the blood vessel at the desired site;

e) deflating the balloon; and

f) withdrawing the catheter and the expandable balloon from the blood vessel.

19. The method of claim 18 wherein the step of providing a stent-graft delivery system further comprises providing a stent-graft delivery system having one sheath positioned over each end of said balloon such that each of the sheaths are adjacent to one of the first and second ends of the stent, and the step of inflating the expandable balloon comprises radially expanding a mid-portion of the balloon while constraining both the first and second ends of the balloon with the sheaths.

20. The method of claim 18 wherein the step of providing a stent-graft delivery system further comprises providing a stent-graft delivery system wherein the first and second ends of the expandable balloon are invertedly attached to the catheter.