Balloon catheter with stent securement means

• US 6,419,685 B2
• Filed: 11/30/2000
• Issued: 07/16/2002
• Est. Priority Date: 08/23/1996
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Dusbabek, Andrew J., Di Caprio, Fernando, Nordin, Stanley A., Ellis, Louis G.
• Primary Examiner(s): TRUONG, KEVIN THAO
• Application Number:
  US09/727,401
• Publication Number:
  US 20010007081A1
• Time in Patent Office: 593 Days
• Field of Search: 606/192, 606/194, 606/195, 606/198, 606/1, 606/108, 604/96.01, 604/101.01, 604/101.02, 604/101.03, 604/103, 623/1.11
• US Class Current: 606/192
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/9522 Means for mounting a stent or stent-graft onto or into a placement instrument
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2002/9586 the means being inside the balloon
• CPC Class Codes: A61M 2025/1013 with concentrically mounted balloons, e.g. being independently inflatable
• CPC Class Codes: A61M 2025/1063 having only one lumen used for guide wire and inflation, e.g. to minimise the diameter
• CPC Class Codes: A61M 2025/1079 having radio-opaque markers in the region of the balloon
• CPC Class Codes: A61M 2025/1093 having particular tip characteristics
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters
• CPC Class Codes: A61M 25/10184 Means for controlling or monitoring inflation or deflation
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

An assembly for delivery and deployment of an inflation expandable stent within a vessel is comprised of a catheter, an inflation expandable stent, an expandable balloon, and a securement means such as a corrugated tube component or an expandable tube component. The tube component is mounted on the inner shaft beneath the balloon and provides increased securement to the stent in a reduced delivery diameter to maintain the stent on the catheter during delivery to the deployment site. The tube component is adhered to the inner shaft and has a plurality of ribs or is fluid expandable to no more than the delivery diameter. and may be comprised of more than one separately inflatable pouch expandable to provide the stent with a substrate seat with increased friction and to decrease the slack in stent recoil crimping. The assembly is used in a method for delivering and deploying a stent, and also adds safety when loading/crimping the stent onto a balloon.

Claims

1. An assembly for delivery and deployment of a stent within a vessel, comprising:

a catheter having a proximal and distal ends;

a stent, expandable from a delivery diameter to a deployment diameter, such that the delivery diameter is reduced from the deployment diameter for conforming the stent to the catheter, such that the stent, in its delivery diameter, is coaxially mounted on the catheter near the catheter distal end;

an expandable balloon coaxially mounted on the catheter within the stent for expansion of the stent from the delivery diameter to the deployment diameter upon application of deployment pressure to the balloon; and

an expandable tube component coaxially mounted on the catheter within the expandable balloon,

wherein the expandable balloon and the expandable tube component are independently expandable relative to one another and wherein the expandable balloon is capable of being substantially collapsed when the expandable tube component is fully expanded.

2. The assembly according to claim 1, the tube component designed and adapted for expansion to provide a securement pressure to the stent in the delivery diameter during delivery to the deployment site.

3. The assembly according to claim 2, wherein the expandable tube component is sized and constructed to be fluid expandable to not more than the delivery diameter and to no more than the securement pressure.

4. The assembly according to claim 2, wherein the tube component is comprised of at least two inflatable pouches.

5. The assembly according to claim 4, wherein the tube component is comprised of three pouches.

6. The assembly according to claim 5, the three pouches being a proximal pouch, a medial pouch and a distal pouch, the pouches being axially spaced on the catheter.

7. The assembly according to claim 6, wherein the proximal and distal pouches are inflatable to a greater pressure than a medial pouch.

8. The assembly according to claim 6, the proximal, distal and medial pouches having an expanded diameter and an unexpanded diameter, wherein the expanded diameter of the medial pouch is less than the expanded diameter of the proximal pouch or the distal pouches.

9. The assembly according to claim 8, wherein the expanded diameter of the medial pouch is less than the expanded diameter of the proximal pouch and the distal pouch.

10. The assembly according to claim 5, wherein the pouches are separately inflatable.

11. The assembly according to claim 4, wherein the at least two pouches are separately inflatable.

12. The assembly according to claim 1, wherein the tube component is essentially equal in length to the stent and wherein the stent is positioned on the assembly essentially coextensive with the tube component.

13. The assembly according to claim 1, further comprising a plurality of inflation lumens.

14. A method for delivering and deploying a stent using an assembly according to claim 1, comprising:

providing a catheter having proximal and distal ends, with an expandable balloon coaxially mounted on the catheter, and an expandable tube component coaxially mounted on the catheter within the expandable balloon, so that the balloon and the tube component are each in an unexpanded condition;

providing a stent which is expandable from a delivery diameter to a deployment diameter;

mounting the stent, in a diameter greater than the delivery diameter, on the balloon;

contracting the stent to the delivery diameter to conform to an overall profile of the catheter, the tube component and the balloon;

inflating the tube component to provide to the stent a securement pressure to retain the stent in the delivery diameter;

delivering the assembly to a deployment site; and

inflating the balloon to expand the stent to its deployment diameter.

15. The method according to claim 14, wherein the expandable tube component is sized and constructed to be fluid expandable to no more than the delivery diameter.

16. The method according to claim 14, wherein the tube component is essentially equal in length to the stent and wherein the stent is positioned on the assembly essentially coextensive with the tube component.

17. The method according to claim 14, wherein the tube component is comprised of at least two inflatable pouches.

18. The assembly according to claim 17, wherein the at least two pouches are separately inflatable.

19. The method according to claim 14, wherein the tube component is comprised of three pouches, with a proximal and distal pouch inflatable to a greater pressure than a medial pouch.

20. The assembly according to claim 19, wherein the pouches are separately inflatable.

21. An assembly for delivery and deployment of a stent within a vessel, comprising:

a catheter having a proximal and distal ends;

an expandable balloon coaxially mounted on the catheter for expansion upon application of pressure to the balloon; and

an expandable tube component coaxially mounted on the catheter within the expandable balloon,

wherein the expandable balloon and the expandable tube component are independently expandable relative to one another and wherein the expandable balloon is capable of being substantially collapsed when the expandable tube component is fully expanded.

22. The assembly according to claim 21, the tube component designed and adapted for expansion to provide a securement pressure to a stent in its delivery diameter during delivery to a deployment site.

23. The assembly according to claim 22, wherein the expandable tube component is sized and constructed to be fluid expandable to not more than the delivery diameter and to no more than the securement pressure.

24. The assembly according to claim 22, wherein the tube component is comprised of at least two inflatable pouches.

25. The assembly according to claim 24, wherein the tube component is comprised of three pouches.

26. The assembly according to claim 25, the three pouches being a proximal pouch, a medial pouch and a distal pouch, the pouches being axially spaced on the catheter.

27. The assembly according to claim 26, wherein the proximal and distal pouches are inflatable to a greater pressure than a medial pouch.

28. The assembly according to claim 25, wherein the pouches are separately inflatable.

29. The assembly according to claim 26, the proximal, distal and medial pouches having an expanded diameter and an unexpanded diameter, wherein the expanded diameter of the medial pouch is less than the expanded diameter of the proximal pouch or the distal pouches.

30. The assembly according to claim 29, wherein the expanded diameter of the medial pouch is less than the expanded diameter of the proximal pouch and the distal pouch.

31. The assembly according to claim 24, wherein the at least two pouches are separately inflatable.

32. The assembly according to claim 21, further comprising a plurality of inflation lumens.

34. The assembly according to claim 23, wherein the expandable balloon may be substantially collapsed when the expandable tube component is in its expanded state.

35. The assembly according to claim 23, wherein the gap extends along the walls of the expandable balloon and the expandable tube component.

36. The assembly according to claim 23, the tube component designed and adapted for expansion to provide a securement pressure to the stent in the delivery diameter during delivery to the deployment site.

37. The assembly according to claim 26, wherein the expandable tube component is sized and constructed to be fluid expandable to not more than the delivery diameter and to no more than the securement pressure.

38. The assembly according to claim 26, wherein the tube component is comprised of at least two inflatable pouches.

39. The assembly according to claim 38, wherein the tube component is comprised of three pouches.

40. The assembly according to claim 39, the three pouches being a proximal pouch, a medial pouch and a distal pouch, the pouches being axially spaced on the catheter.

41. The assembly according to claim 40, wherein the proximal and distal pouches are inflatable to a greater pressure than a medial pouch.

42. The assembly according to claim 40, the proximal, distal and medial pouches having an expanded diameter and an unexpanded diameter, wherein the expanded diameter of the medial pouch is less than the expanded diameter of the proximal pouch or the distal pouches.

43. The assembly according to claim 42, wherein the expanded diameter of the medial pouch is less than the expanded diameter of the proximal pouch and the distal pouch.

44. The assembly according to claim 39, wherein the pouches are separately inflatable.

45. The assembly according to claim 38, wherein the at least two pouches are separately inflatable.

33. An assembly for delivery and deployment of a stent within a vessel, comprising:

a catheter having a proximal and distal ends;

a stent, expandable from a delivery diameter to a deployment diameter, such that the delivery diameter is reduced from the deployment diameter for conforming the stent to the catheter, such that the stent, in its delivery diameter, is coaxially mounted on the catheter near the catheter distal end;

an expandable balloon coaxially mounted on the catheter within the stent for expansion of the stent from the delivery diameter to the deployment diameter upon application of deployment pressure to the balloon, the balloon having an inner wall, an expanded state and a collapsed state; and

an expandable tube component coaxially mounted on the catheter within the expandable balloon, the expandable tube having an outer wall, an expanded state and a collapsed state,

wherein, when the expandable balloon and the expandable tube component are in their expanded states, there is a gap between the inner wall of the expandable balloon and the outer wall of the expandable tube component and wherein the expandable balloon is capable of being substantially collapsed when the expandable tube component is fully expanded.

46. The assembly according to claim 33, wherein the tube component is essentially equal in length to the stent and wherein the stent is positioned on the assembly essentially coextensive with the tube component.

47. The assembly according to claim 33, further comprising a plurality of inflation lumens.