Stent delivery system

• US 4,950,227 A
• Filed: 11/07/1988
• Issued: 08/21/1990
• Est. Priority Date: 11/07/1988
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Corporation
• Inventors: Windheuser, James E., Noddin, Richard A., Savin, Michael A.
• Primary Examiner(s): Hafer, Robert A.
• Assistant Examiner(s): Cofsky, Lynda M.
• Application Number:
  US07/267,575
• Time in Patent Office: 652 Days
• Field of Search: 128/341, 128/343, 128/344, 128/303 R, 604/8, 604/104, 604/96, 604/281
• US Class Current: 623/1.12
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2002/9583 Means for holding the stent on the balloon, e.g. using protrusions, adhesives or an outer sleeve
• CPC Class Codes: A61F 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61L 31/14 Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• CPC Class Codes: A61L 31/18 Materials at least partially X-ray or laser opaque

Abstract

A stent delivery system to facilitate introduction and placement of a stent, including a catheter having an expansible distal portion constructed and arranged for expanding the outer diameter of the catheter from a contracted state to an expanded state; a stent positioned around the distal portion of the catheter, having a contracted condition and being expansible to an expanded condition, and being sized in the contracted condition to closely surround the catheter in the contracted state, the stent having an end portion defining a margin lying over the expansible portion of the catheter; a sleeve in the region of the distal portion of the catheter positioned around the catheter having a first end fixed to the catheter and a second end defining a margin lying over the margin of the stent; the sleeve fixing the end of the stent on the catheter when the catheter is in the contracted state, the catheter and stent cooperatively constructed and arranged to cause expansion of the catheter from its contracted state to its expanded state to cause expansion of the stent, including the margin of the stent, from its contracted condition to its expanded condition, and therewith cause the margin of the sleeve to slide axially from over the margin of the stent thereby releasing the end of the stent from the catheter.

Claims

1. A stent delivery system comprising:

a catheter comprising an expansible distal portion constructed and arranged for expanding the outer diameter of said catheter from a contracted state to an expanded state,

a stent positioned around said distal portion of said catheter, said stent having a contracted condition and being expansible to an expanded condition, and being sized in said contracted condition to closely surround said catheter in the contracted state, said stent having an end portion defining a margin lying over said expansible portion of said catheter,

a sleeve in the region of said distal portion of said catheter positioned around said catheter, having a first end fixed to said catheter, and a second end defining a margin lying over said margin of said stent;

said sleeve fixing said end of said stent on said catheter when said catheter is in the contracted state, said catheter and stent cooperatively constructed and arranged to cause expansion of said catheter from said contracted state to said expanded state to cause expansion of said stent, including said margin of said stent, from said contracted condition to said expanded condition, and therewith cause said margin of said sleeve to slide relatively axially from over the margin of said stent, thereby releasing said end of the stent from said catheter.

2. The stent delivery system of claim 1, wherein said expansible distal portion comprises a balloon mounted on a shaft of the catheter.

3. The stent delivery system of claim 2, wherein said stent is expanded by expansion of said balloon.

4. The stent delivery system of claim 1 further comprising fixing means for holding said sleeve at a specific location on said catheter.

5. The stent delivery system of claim 4, said fixing means being a detent formed from adhesive.

6. The stent delivery system of claim 1, further comprising a hemostasis valve sheath, positioned through the skin into a body cavity, adapted to permit said catheter to be introduced through said sheath into said body cavity without injuring said cavity.

7. The stent delivery system of claim 1, wherein said sleeve overlaps said stent at said margin for a maximum distance of 3 mm.

8. The stent delivery system of claim 1, said sleeve being formed from silicone.

9. The stent delivery system of claim 1, said sleeve being formed from any elastomer able to be expanded at least two times by internal pressure below that usable with a balloon angioplasty catheter, and formable into a thin-walled tube.

10. The stent delivery system of claim 9, said pressure being between about 3-17 atmospheres.

11. The stent delivery system of claim 1, said stent being able to expand elastically in diameter.

12. The stent delivery system of claim 1, said stent being able to expand plastically in diameter.

13. The stent delivery system of claim 1, said end of said stent being a distal end, wherein said sleeve fixes said stent at the distal end of said stent.

14. The stent delivery system of claim 1, said sleeve being formed in the shape of a cylinder.

15. The stent delivery system of claim 1, said sleeve having axially running regions of weakness where said sleeve contacts said stent.

16. The stent delivery system of claim 1, wherein a lubricant is provided between said sleeve and said catheter.

17. The stent delivery system of claim 1, said stent having a lubricious or hydrophilic coating.

18. The stent delivery system of claim 1, said sleeve being formed of radiopaque material.

19. The stent delivery system of claim 18, said sleeve comprising a barium salt.

20. The stent delivery system of claim 1, said stent being able to expand superelastically in diameter.

22. The stent delivery system of claim 1 or 21 wherein a said sleeve is elastomeric in a contracted state about said catheter, squeezing the margin of said stent thereagainst.

23. The stent delivery system of claim 22, said balloon having a tapered diameter along all or part of the section under the stent.

24. The stent delivery system of claim 22, wherein only a portion of the stent is positioned over said balloon.

25. The stent delivery system of claim 22, said balloon having a tapered diameter along all of the section under the stent.

26. The stent delivery system of claim 1 or 21 wherein said stent is formed of knitted material and the length of said stent does not significantly change when said stent is expanded.

27. The stent delivery system of claim 1 or 21 wherein said stent is formed of material that enables the stent to decrease in length when said stent is expanded.

36. A method for positioning a stent within a body cavity, comprising the steps of:

(a) providing the stent delivery system of claim 1;

(b) introducing said stent delivery system into said body cavity;

(c) causing said distal portion of said catheter to expand and thereby simultaneously plastically deforming said stent and causing said margin to be released from said sleeve;

(d) at least partially contracting said catheter; and

(e) removing said catheter and said sleeve from said body cavity by axially pulling said catheter from the body cavity.

21. A stent delivery system comprising:

a catheter comprising an expansible distal portion constructed and arranged for expanding the outer diameter of said catheter from a contracted state to an expanded state,

a stent positioned around said distal portion of said catheter, said stent having a contracted condition and being expansible to an expanded condition, and being sized in said contracted condition to closely surround said catheter in the contracted state, said stent having a first and second end portion defining a first and second margin lying over said expansible portion of said catheter,

a first and second sleeve in the region of said distal portion of said catheter positioned around said catheter, each having a first end fixed to said catheter and a second end defining a margin lying over a said margin of said stent,

said first sleeve and said second sleeve separately engaging said stent at said first margin and said second margin respectively;

said first and second sleeve fixing said ends of said stent on said catheter when said catheter is in the contracted state, said catheter and stent cooperatively constructed or arranged to cause expansion of said catheter from said contracted state to said expanded state to cause expansion of said stent, including said first and second margin of said stent, from said contracted condition to said expanded condition, and therewith cause said first and second margins of said sleeve to slide relatively axially from over the margins of said first and second stent, thereby simultaneously releasing said ends of the stent from said catheter.

28. A method for fastening a stent to a catheter in a manner suitable for facilitating introduction, and later release, of said stent into a body cavity, comprising the steps of:

(a) providing a catheter having an expansible distal portion constructed and arranged for expanding the outer diameter of said catheter, said distal portion an expanded and a contracted state;

(b) providing a stent having an expanded and a contracted condition;

(c) sliding said stent axially over said catheter in the contracted state and about said distal

(d) providing a sleeve in an expanded form, said sleeve also having a contracted form;

(e) sliding said expanded sleeve axially over said catheter and about a portion of said stent; and

(f) allowing said sleeve to contract about said catheter and said stent and thereby fix said stent to said catheter when said catheter and said stent are in their contracted state or condition;

said catheter and stent cooperating whereby said sleeve is released from said stent when said catheter is in its expanded state and said stent is in its expanded condition.

29. The method of claim 28, wherein said sleeve is formed of silicone and said expanded form of said sleeve is provided by soaking said sleeve in freon.

30. The method of claim 29 wherein said sleeve is allowed to contract by causing release of said freon from said sleeve.

31. The method of claim 28, wherein said sleeve is formed of a polymeric material that has the ability to expand more than two times in diameter and retract back to almost its original dimension.

32. The method of claim 31 wherein said material is chosen from latex, polyurethane, or polyether amide in water.

33. The method of claim 31 wherein said sleeve is held on the catheter by an adhesive detent.

34. The method of claim 28 wherein two said sleeves are provided;

one said sleeve is fixed about a distal end of said stent and the other said sleeve about a proximal end of said stent.

35. The method of claim 28 further comprising the step of providing a fixing means for holding said sleeve at a specific location on said catheter.