Balloon catheter with stent securement means

• US 6,881,216 B2
• Filed: 06/17/2002
• Issued: 04/19/2005
• Est. Priority Date: 08/23/1996
• Status: Expired due to Fees

• Current Assignee: e2Interactive Incorporated
• Original Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Inventors: Dusbabek, Andrew J., Di Caprio, Fernando, Nordin, Stanley A., Ellis, Louis G.
• Primary Examiner(s): TRUONG, KEVIN THAO
• Application Number:
  US10/172,182
• Publication Number:
  US 20020156519A1
• Time in Patent Office: 1,037 Days
• Field of Search: 606/192, 606/195, 606/198, 604/96.01, 604/101.01, 604/101.02, 604/101.03, 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. A catheter assembly, comprising:

a catheter having a proximal and distal ends;

an expandable outer balloon coaxially mounted on the distal end of the catheter, the expandable outer balloon having a collapsed state and an expanded state, a distal end and a proximal end and an inner wall and an outer wall;

a stent coaxially mounted on the expandable outer balloon, the stent having an expanded; and

a first inner expandable balloon coaxially mounted on the catheter within the expandable balloon, the first inner expandable balloon having a collapsed state and an expanded state and a distal end and a proximal end,

the catheter having a first inflation conduit in direct fluid communication with the inner wall of the expandable outer balloon, the first inflation conduit designed to inflate the expandable outer balloon to its expanded state.

2. The catheter assembly according to claim 1, further comprising a second inflation conduit in direct communication with the first inner expandable balloon, the second inflation conduit designed to inflate the first inner expandable balloon to its expanded state.

3. The catheter assembly according to claim 2, wherein the first and second inflation conduits work independently.

4. The catheter assembly according to claim 3, the stent being 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 and such that the stent, in its delivery diameter, is coaxially mounted on the catheter near the catheter distal end over the first inner expandable balloon, the intent being substantially in its delivery diameter when the first inner expandable balloon is in its expanded state.

5. The catheter assembly according to claim 2, the catheter comprising an inner tube, wherein the distal end of the first inner expandable balloon is connected to the inner tube.

6. The catheter assembly according to claim 5, wherein the distal end of the expandable outer balloon is connected to the inner tube.

7. The catheter assembly according to claim 5, further comprising an outer sheath surrounding the inner tube, wherein the proximal end of the expandable outer balloon is attached to the outer sheath.

8. The catheter assembly according to claim 7, further comprising an intermediate tube between the inner tube and the outer sheath, wherein the proximal end of the inner tube is attached to the intermediate tube.

9. The catheter assembly according to claim 8, wherein the first inflation conduit is formed between the outer sheath and the intermediate tube and the second inflation conduit is formed between the intermediate tube and the inner tube.

10. The catheter assembly according to claim 7, wherein the proximal end of the first inner expandable balloon is attached to the inner tube.

11. The catheter assembly according to claim 10, wherein the first inflation conduit is formed between the outer sheath and the inner tube and the second inflation conduit is housed in the inner tube.

12. The catheter assembly according to claim 2, further comprising a second inner balloon within the expandable outer balloon, the second inner balloon being positioned axially from the first inner expandable balloon.

13. The catheter assembly according to claim 12, further comprising a third inner balloon within the expandable outer balloon, the third inner balloon being position axially from the first inner expandable balloon, the third inner balloon being positioned axially opposite from the positioning of the second inner balloon relative to the first inner expandable balloon, the second and third inner balloons having a collapsed state and an expanded state.

14. The catheter assembly according to claim 13, further comprising a third and fourth inflation conduit in communication with the second and third inner balloons, respectively, the second, third and fourth inflation conduits being housed within the inner tube.

15. The catheter assembly according to claim 13, further comprising an inner tube wherein the first, second and third inner balloons are attached to the inner tube.

16. The catheter assembly according to claim 15, further comprising an outer sheath surrounding the inner tube, wherein the proximal end of the expandable outer balloon is attached to the outer sheath.

17. The catheter assembly according to claim 12, wherein the expanded stale of the second inner balloon has a greater diameter that the diameter of the first inner expandable balloon in its expanded state.

18. The catheter assembly according to claim 13, wherein the expanded states of the second and third inner balloons have a greater diameter that the diameter of the first inner expandable balloon in its expanded state.

19. The catheter assembly according to claim 4, wherein the first inner expandable balloon is essentially equal in length to the intent and wherein the stent is positioned on the assembly essentially coextensive with the first inner expandable balloon.

20. The catheter assembly according to claim 18, the stent being 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 and such that the stent, in its delivery diameter, is coaxially mounted on the catheter near the catheter distal end over the first inner expandable balloon, the intent being substantially in its delivery diameter when the first inner expandable balloon is in its expanded state, wherein the first inner expandable balloon is essentially equal in length to the stent and wherein the stent is positioned on the assembly essentially coextensive with the first inner expandable balloon.

21. The catheter assembly according to claim 4, wherein the outer diameter of the first inner expandable balloon is approximately equal to the inner delivery diameter of the stent.

22. The catheter assembly according to claim 20, wherein the outer diameter of the first inner expandable balloon is approximately equal to the inner delivery diameter of the stent.

23. The catheter assembly of claim 1, wherein the expandable outer balloon and the first inner expandable balloon are independently expandable relative to one another and wherein the expandable outer balloon is capable of being substantially collapsed when the first inner expandable balloon is fully expanded.

24. The catheter assembly of claim 1, wherein the expandable outer balloon and the first inner expandable balloon are substantially not in contact when the expandable outer balloon is expanded.

25. The catheter assembly of claim 4, wherein the expandable outer balloon and the first inner expandable balloon are independently expandable relative to one another, such that the expandable outer balloon is capable of expanding the stent from its delivery diameter to its deployment diameter independent of the expansion of the first inner expandable balloon.

26. The catheter assembly of claim 1, wherein the first inner expandable balloon is not designed to expand the stent to its deployment diameter.

27. The catheter assembly of claim 1, further the expandable outer balloon or the first inner expandable balloon may be substantially expanded at the same time the other is substantially collapsed.

28. The catheter assembly of claim 4, the first inner expandable balloon being attached to the catheter in no more than two places, having a certain length and forming a continuous covering over the inner tube, wherein the first inner expandable balloon is approximately at least the length of the stent.

29. The catheter assembly of claim 4, the first inner expandable balloon designed and adapted for fluid expansion to provide a securement pressure to the stent in the delivery diameter to maintain the stent in position on the catheter during delivery to the deployment site.