Stent delivery system

• US 6,626,934 B2
• Filed: 01/02/2001
• Issued: 09/30/2003
• Est. Priority Date: 06/14/1999
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Blaeser, David J., Mattison, Richard C.
• Primary Examiner(s): Robert, Eduardo C.
• Application Number:
  US09/753,533
• Publication Number:
  US 20010012959A1
• Time in Patent Office: 1,001 Days
• Field of Search: 623/1.11, 606/108, 606/198, 606/194
• US Class Current: 623/1.11
• 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 2002/9665 with additional retaining means
• CPC Class Codes: A61F 2250/0029 differing in bending or flexure capacity

Abstract

The present invention provides an apparatus for delivery and deployment of an expandable stent within a vessel. The apparatus comprises a catheter having a proximal end, a distal end and a catheter shaft, an expandable stent coaxially mounted on the catheter near the distal end of the catheter and a securement apparatus coaxially mounted on the catheter near its distal end and over the stent. The securement apparatus comprises a securement sleeve having a proximal end, a distal end, an exterior surface and an interior surface. The securement sleeve is constructed and arranged for proximal advancement along the catheter shaft. The present invention also includes a distal cuff having a proximal end, a distal end, an exterior surface and an interior surface. The distal cuff is mounted near the distal end of the catheter and is constructed and arranged to closely surround the exterior surface of the securement sleeve at the distal end of the securement sleeve until proximal advancement thereof and subsequent deployment of the stent.

Claims

1. An apparatus for delivery and deployment of an expandable stent within a vessel, the apparatus comprising:

a) a catheter having a proximal end, a distal end and a catheter shaft;

b) an expandable stent, expandable from a delivery diameter to a deployment diameter, the stent being coaxially mounted on the catheter; and

c) securement means coaxially mounted on the catheter near its distal end, remote from the proximal end of the catheter, and over the stent, said securement means comprising;

i) a securement sheath having a proximal end, a distal end, an exterior surface and an interior surface, said securement sheath being constructed and arranged for proximal retraction along the catheter shaft to expose the stent, the securement sheath having a plurality of flexibility enhancing elements; and

ii) a distal cuff having a proximal end, a distal end, an exterior surface and an interior surface, said distal cuff being mounted near the distal end of the stent and being constructed and arranged to engage the securement sheath at the distal end of the securement sheath until retraction thereof.

2. The apparatus of claim 1, wherein the proximal end of the securement sheath is slidably sealed on the distal end of the catheter.

3. The apparatus of claim 2 wherein the catheter shaft further comprises an hydraulic perfusion port located distally of the proximal end of the securement sleeve, the securement sleeve being constructed and arranged for retraction in response to fluid pressure.

4. The apparatus of claim 1, further comprising an expandable means coaxially mounted on the catheter and operably located axially within the stent for expansion thereof, a portion of the securement sheath being over the expandable means.

5. The apparatus of claim 1 wherein the catheter further comprises a stop collar coaxially mounted on the distal end of the catheter shaft proximal of the securement means, said stop collar being constructed and arranged to limit the proximal advancement of the securement sheath.

6. An apparatus of claim 1 wherein the catheter further comprises a wire pull back means associated with the stent securement means, and the securement sleeve is constructed and arranged for proximal advancement by said wire pull back means.

7. The apparatus of claim 6 wherein the distal cuff is made of an elastomeric material.

8. The apparatus of claim 6, further comprising an expandable means coaxially mounted on the catheter, wherein the sheath is approximately the length of the expandable means.

9. The apparatus of claim 6, wherein the sheath is free from perforations.

10. The apparatus of claim 6 wherein the catheter further comprises a stop collar coaxially mounted on the distal end of the catheter shaft proximal of the securement means, said stop collar being constructed and arranged to limit the proximal advancement of the securement sheath.

11. The apparatus of claim 1, further comprising an expandable means coaxially mounted on the catheter, wherein the sheath is approximately the length of the expandable means.

12. The apparatus of claim 1, wherein the sheath is free from perforations.

13. The apparatus of claim 1, wherein the proximal end of the sheath is sealingly attached to the catheter shaft.

14. The apparatus of claim 13, further comprising a hydraulic perfusion port in the catheter shaft located distally of the proximal end of the securement sheath, the securement sheath being constructed and arranged for retraction in response to fluid pressure, and a slidable seal proximal along the catheter shaft to the stent created by the proximal end of the sheath and the catheter shaft, creating a chamber within the sheath, whereby fluid or gas may be forced through the perfusion port into the chamber forcing the sheath to slide proximally to release the stent.

15. The apparatus of claim 1 wherein a portion of the distal cuff is attached to the catheter shaft.

16. The apparatus of claim 1 wherein the flexibility enhancing elements comprise a plurality of holes in the securement sheath.

17. The apparatus of claim 1 wherein the flexibility enhancing elements comprise a plurality of dimples in the securement sheath.

18. The apparatus of claim 1 wherein the flexibility enhancing elements comprise a plurality of radial indentations in the securement sheath.

19. An apparatus for delivery and deployment of an expandable stent within a vessel, the apparatus comprising:

a) a catheter having a proximal end portion, a middle portion, a distal end portion and a catheter shaft;

b) an expandable stent, expandable from a delivery diameter to a deployment diameter, the stent being coaxially mounted about the catheter at the distal end portion of the catheter, and

c) securement means coaxially mounted on the catheter at its distal end portion, distal the middle portion, and about the stent, said securement means comprising;

i) a securement sheath having a plurality of flexibility enhancing elements a proximal end, a distal end, an exterior surface and an interior surface, said securement sheath being mounted on the catheter shaft and being constructed and arranged for retraction along the catheter shaft, the securement sheath having a wall thickness of about 0.005 inches or less, and

ii) a distal cuff having a proximal end, a distal end, an exterior surface and an interior surface, said distal cuff being mounted near the distal end of the catheter and being constructed and arranged to closely and releasably engage the securement sheath at the distal end of the securement sheath until retraction thereof and subsequent deployment of the stent.

20. The apparatus of claim 19, wherein the proximal end of the securement sheath is slidably sealed on the distal end of the catheter.

21. The apparatus of claim 20 wherein the catheter shaft further comprises an hydraulic perfusion port located distally of the proximal end of the securement sleeve, the securement sleeve being constructed and arranged for retraction in response to fluid pressure.

22. The apparatus of claim 19, further comprising an expandable means coaxially mounted on the catheter and operably located axially within the stent for expansion thereof, a portion of the securement sheath being over the expandable means.

23. The apparatus of claim 19 wherein the catheter further comprises a stop collar coaxially mounted on the distal end of the catheter shaft proximal of the securement means, said stop collar being constructed and arranged to limit the proximal advancement of the securement sheath.

24. An apparatus of claim 19 wherein the catheter further comprises a wire pull back means associated with the stent securement means, and the securement sleeve is constructed and arranged for proximal advancement by said wire pull back means.

25. The apparatus of claim 24 wherein the distal cuff is made of an elastomeric material.

26. The apparatus of claim 24 wherein a portion of the distal cuff is attached to the catheter shaft.

27. The apparatus of claim 24 wherein the distal cuff is attached to the catheter shaft.

28. The apparatus of claim 19 wherein the flexibility enhancing elements comprise a plurality of holes in the securement sheath.

29. The apparatus of claim 19 wherein the flexibility enhancing elements comprise a plurality of dimples in the securement sheath.

30. The apparatus of claim 19 wherein the flexibility enhancing elements comprise a plurality of radial indentations in the securement sheath.

31. In a stent delivery catheter, the catheter having a proximal end, a middle portion and a distal end, the improvement comprising a stent covering sheath having a proximal and distal end, the proximal end of the sheath being slidably gripped to the catheter, distal from the middle portion of the catheter, and a cuff releasably covering the distal end of the sheath, the cuff being attached to the catheter, the sheath having a flexibility enhancer.

32. In the stent delivery catheter of claim 31, wherein sheath comprises a plurality of flexibility enhancers.

33. An apparatus for delivery and deployment of an expandable stent within a vessel, the apparatus comprising:

a) a catheter having a proximal end, a middle portion, a distal end and a catheter shaft;

b) an expandable stent, expandable from a delivery diameter to a deployment diameter, the stent being coaxially mounted on the catheter;

c) securement means coaxially mounted on the catheter near its distal end, distal the middle portion, and over the stent, said securement means comprising;

i) a securement sheath having a proximal end, a distal end, an exterior surface and an interior surface, said securement sheath being slidably mounted on the catheter shaft and being constructed and arranged for proximal retraction along the catheter shaft to expose the stent, the securement sheath having a plurality of flexibility enhancing elements; and

ii) a distal cuff having a proximal end, a distal end, an exterior surface and an interior surface, said distal cuff being mounted near the distal end of the stent and being constructed and arranged to engage the securement sheath at the distal end of the securement sheath until retraction thereof.

34. The apparatus of claim 33 wherein the flexibility enhancing elements comprise a plurality of holes in the securement sheath.

35. The apparatus of claim 33 wherein the flexibility enhancing elements comprise a plurality of dimples in the securement sheath.

36. The apparatus of claim 33 wherein the flexibility enhancing elements comprise a plurality of radial indentations in the securement sheath.

37. An apparatus for delivery and deployment of an expandable stent within a vessel, the apparatus comprising:

a) a catheter having a proximal end, a middle portion, a distal end and a catheter shaft;

b) an expandable stent, expandable from a delivery diameter to a deployment diameter, the stent being coaxially mounted on the distal end of the catheter for expansion thereof;

d) securement means coaxially mounted on the catheter near its distal end, distal the middle portion, and over the stent, said securement means comprising;

i) a securement sheath having a proximal end, a distal end, an exterior surface and an interior surface, said securement sheath being slidably mounted on the catheter and being constructed and arranged for proximal retraction along the catheter to expose the stent, the securement sheath having a plurality of flexibility enhancing elements.

38. The apparatus of claim 37 wherein the flexibility enhancing elements comprise a plurality of holes in the securement sheath.

39. The apparatus of claim 38 wherein the flexibility enhancing elements comprise a plurality of radial indentations in the securement sheath.

40. The apparatus of claim 37 wherein the flexibility enhancing elements comprise a plurality of dimples in the securement sheath.

41. The apparatus of claim 37, wherein the securement means further comprises, a distal cuff having a proximal end, a distal end, an exterior surface and an interior surface, said distal cuff being mounted near the distal end of the stent and being constructed and arranged to closely engage the securement sheath at the distal end of the securement sheath until retraction thereof.

42. In a stent delivery catheter, the catheter having a proximal end, a middle portion and a distal end, the improvement comprising a stent covering sheath having a proximal and distal end, the proximal end of the sheath being slidably gripped to the catheter, distal from the middle portion of the catheter, the sheath having a flexibility enhancer.

43. In the stent delivery catheter of claim 42, wherein the sheath comprises a plurality of flexibility enhancers.

44. In the stent delivery catheter of claim 42, wherein the flexibility enhancer is the thinness of the sheath, the sheath having a wall thickness of about 0.005 inches or less.