Chronic total occlusion device with variable stiffness shaft

• US 20040073163A1
• Filed: 11/07/2003
• Published: 04/15/2004
• Est. Priority Date: 07/30/2001
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Tomaschko, Daniel K., Volk, Angela Kornkven
• Granted Patent: US 7,695,465 B2
• Time in Patent Office: Days
• US Class Current: 604/103.03
• CPC Class Codes: A61M 2025/0004 having two or more concentrically arranged tubes for forming a concentric catheter system
• CPC Class Codes: A61M 2025/0063 having means, e.g. stylets, mandrils, rods or wires to reinforce or adjust temporarily the stiffness, column strength or pushability of catheters which are already inserted into the human body
• CPC Class Codes: A61M 2025/1061 having separate inflations tubes, e.g. coaxial tubes or tubes otherwise arranged apart from the catheter tube
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

The present invention relates generally to a device for adding stiffening support to a guidewire so as to enable the guidewire or device to pass through a chronic total occlusion. A method for passing a guidewire through a chronic total occlusion is also disclosed.

Claims

1. A chronic total occlusion device, comprising:

an outer tubular member including a proximal end, a distal end, and a lumen extending therethrough;

an inner tubular member disposed within the lumen, the inner tubular member having an inner lumen;

an annular space between the outer tubular member and the inner tubular member; and

a stiffening member disposed within the annular space.

2. The device in accordance with claim 1, wherein a manifold is disposed at the proximal end of the outer tubular member.

3. The device in accordance with claim 2, wherein the manifold includes means for controlling the stiffening member.

4. The device in accordance with claim 1, wherein the stiffening member further comprises a distal head and a proximal tail.

5. The device in accordance with claim 4, wherein the stiffening member is movable relative to the outer tubular member.

6. The device in accordance with claim 1, wherein the outer tubular member further comprises an expandable region.

7. The device in accordance with claim 6, wherein the expandable region comprises a balloon.

8. The device in accordance with claim 7, wherein the annular space is in fluid communication with the balloon.

9. The device in accordance with claim 6, wherein the expandable region further comprises a first region having a first outside diameter and a second region having a second outside diameter.

10. The device in accordance with claim 9, wherein the first outside diameter is less than the second outside diameter.

11. The device in accordance with claim 9, wherein the stiffening member comprises a liquid.

12. The device in accordance with claim 9, wherein the stiffening member comprises a gas.

13. A chronic total occlusion device, comprising:

an outer tubular member including a proximal end, a distal end, a lumen extending therethrough, and an expandable region having a first region having a first outside diameter, and a second region having a second outside diameter;

an inner tubular member disposed within the lumen, the inner tubular member having an inner lumen;

an annular space between the outer tubular member and the inner tubular member; and

a stiffening member disposed within the annular space.

14. The device in accordance with claim 13, wherein a manifold is disposed at the proximal end of the outer tubular member.

15. The device in accordance with claim 14, wherein the manifold includes means for controlling the stiffening member.

16. The device in accordance with claim 13, wherein the stiffening member further comprises a distal head and a proximal tail.

17. The device in accordance with claim 16, wherein the stiffening member is movable relative to the outer tubular member.

18. The device in accordance with claim 13, wherein the expandable region comprises a balloon.

19. The device in accordance with claim 18, wherein the annular space lumen is in fluid communication with the balloon.

20. The device in accordance with claim 13, wherein the first outside diameter is less than the second outside diameter.

21. The device in accordance with claim 13, wherein the stiffening member comprises a liquid.

22. The device in accordance with claim 13, wherein the stiffening member comprises a gas.

23. A method for passing a guidewire through a chronic total occlusion, the method comprising the steps of:

placing a guidewire in a blood vessel proximate a chronic total occlusion;

providing a chronic total occlusion device, the chronic total occlusion device including an outer tubular member having a proximal end, a distal end, and a lumen extending therethrough;

an inner tubular member disposed within the lumen and having an inner lumen; and

an annular space between the outer tubular member and the inner tubular member;

passing the chronic total occlusion device over the guidewire such that the guidewire is disposed within the inner lumen; and

passing the guidewire through the chronic total occlusion.

24. The method in accordance with claim 23, wherein the chronic total occlusion device further comprise a stiffening member disposed within the annular space.

25. The method in accordance with claim 24, wherein the stiffening member further comprises a distal head and a proximal tail.

26. The method in accordance with claim 24, wherein the stiffening member comprises a liquid.

27. The method in accordance with claim 24, wherein the stiffening member comprises a gas.

28. The method in accordance with claim 24, further comprising the step of actuating the stiffening member.

29. The method in accordance with claim 28, wherein the step of actuating the stiffening member includes moving the stiffening member toward the distal end of the outer tubular member.

30. The method in accordance with claim 23, wherein the outer tubular member further comprises an expandable region.

31. The method in accordance with claim 30, wherein the expandable region comprises a balloon.

32. The method in accordance with claim 31, wherein the annular space is in fluid communication with the balloon.

33. The method in accordance with claim 30, wherein the expandable region further comprises a first region having a first outside diameter and a second region having a second outside diameter.

34. The method in accordance with claim 33, wherein the first outside diameter is less than the second outside diameter.

35. The method in accordance with claim 23, wherein the chronic total occlusion comprises a calcified lesion.

36. The method in accordance with claim 23, wherein the chronic total occlusion comprises a stenosis.

37. The method in accordance with claim 23, wherein the chronic total occlusion comprises an atherosclerotic lesion.