Coiled, perfusion balloon catheter

• US 5,226,888 A
• Filed: 10/25/1991
• Issued: 07/13/1993
• Est. Priority Date: 10/25/1991
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Arney, Michelle
• Primary Examiner(s): Rosenbaum, C. Fred
• Assistant Examiner(s): Maglione, Corrine
• Application Number:
  US07/782,518
• Time in Patent Office: 627 Days
• Field of Search: 604/53, 604/96-103, 606/191-194
• US Class Current: 604/103.07
• CPC Class Codes: A61M 2025/1097 with perfusion means for enabling blood circulation only while the balloon is in an inflated state, e.g. temporary by-pass within balloon
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 25/104 used for angioplasty
• CPC Class Codes: Y10T 29/4981 Utilizing transitory attached element or associated separate material
• CPC Class Codes: Y10T 29/49881 of separate helix [e.g., screw thread]

Abstract

A perfusion balloon catheter includes an inflatable balloon formed by a series of loops of a flexible, inflatable tube in a generally cooperative tubular shape. The loops are supported by a coiled support member and are locked within the coiled support member by a wire retainer. The cooperative tubular shape of the individual loops perform to provide an inflatable cooperative outer surface of the balloon and a perfusion passage within the balloon.

Claims

1. A perfusion balloon catheter comprising:

an elongated tubular shaft having a proximal end, a distal end and a lumen extending therethrough;

a helical coil of flexible, inflatable tube disposed at the distal end of the tubular shaft, the tube having a proximal end in fluid communication with the lumen and having a sealed distal end, the helical coil forming a composite outer surface and composite inner surface which define an inflatable tubular-shaped balloon, the composite inner surface further defining a perfusion passage;

a longitudinally-extending support structure through which the tube is looped to form the balloon; and

retainer means for securing the tube to the support structure.

2. The perfusion balloon catheter of claim 1 wherein the support structure is a coiled support member.

3. The perfusion balloon catheter of claim 2 wherein the retainer means includes a wire which extends through the coiled support member to capture loops of the tube in the coiled support member.

4. The perfusion balloon catheter of claim 3 wherein a first length of tube is inside the coiled support member.

5. The perfusion balloon catheter of claim 4 wherein the proximal end of the tube is positioned within the shaft lumen.

6. The perfusion balloon catheter of claim 5 wherein a second length of the tube extends outside of the coiled support member and is looped around the coiled support member to form a plurality of adjacent loops which cooperate to form the inflatable balloon.

7. The perfusion balloon catheter of claim 6 wherein the tubular-shaped balloon has an inner diameter which is larger than an outer diameter of the coiled support member thereby forming the perfusion passage, which extends from a proximal end to a distal end of the balloon.

8. The perfusion balloon catheter of claim 7 and further comprising means for connecting adjacent loops of the tubular-shaped balloon.

9. The perfusion balloon catheter of claim 7 wherein the perfusion passage has an opening, upon inflation of the balloon, with a cross-sectional area of greater than about 15 percent of a total cross-sectional area of the opening and the balloon.

10. The perfusion balloon catheter of claim 2 wherein the retainer means is positioned between each loop of the tube and an inner surface of the coiled support member.

11. The perfusion balloon catheter of claim 2 wherein the tubular shaft includes an outer surface, an inner surface and an opening at the distal end of the shaft and wherein the coiled support member includes an outer surface and a proximal end, the opening and the inner surface of the distal end of the tubular shaft conformably accepting the outer surface of the proximal end of the coiled support member, the proximal end of the coiled support member bonded within the distal end of the tubular shaft.

12. A perfusion balloon catheter comprising:

an elongated tubular shaft having a proximal end, a distal end, and a shaft lumen which extends from the proximal to the distal end;

a balloon support extending distally from the distal end of the shaft, the balloon support including a helical wire coil; and

a flexible, inflatable tube having a proximal end in fluid communication with the shaft lumen and having a sealed distal end, the inflatable tube being wound over the helical wire coil to form a plurality of adjacent loops which, upon inflation of the tube, form a composite balloon having an outer surface for applying outward force to a vessel wall and an inner surface for defining a fluid passage through the balloon to permit perfusion while the balloon is inflated.

13. The perfusion balloon catheter of claim 12 wherein the balloon support further includes:

retainer means for holding the inflatable tube in the helical wire coil.

14. The perfusion balloon catheter of claim 12 and further comprising:

a guide wire external and adjacent to the shaft; and

guide means external to and extending distally from the shaft for engaging the guide wire to permit longitudinal movement of the balloon along the guide wire.

15. The perfusion balloon catheter of claim 12 wherein the fluid passage, when the balloon is inflated, has an opening which has a cross-sectional area which is greater than about 15 percent of a total cross-sectional area of the opening and the balloon.

16. A perfusion balloon catheter comprising:

an elongated tubular shaft having a proximal end, a distal end and an inner surface which defines a lumen from the proximal end to the distal end, the lumen further being exposed by an opening at the distal end of the shaft;

a helical coil of flexible, inflatable tube disposed at the distal end of the tubular shaft to form an inflatable tubular-shaped balloon, the tube having a proximal end in fluid communication with the lumen and having a sealed distal end;

a longitudinally-extending support structure through which the tube is looped to form the balloon, wherein the support structure is a coiled support member having an outer surface, a proximal end and a distal end; and

retainer means for securing the tube to the support structure, wherein the retainer means includes a wire which extends through the coiled support member to capture loops of the tube in the coiled support member.

17. The perfusion balloon catheter of claim 16 wherein a first length of tube is inside the coiled support member.

18. The perfusion balloon catheter of claim 17 wherein the proximal end of the tube is positioned within the shaft lumen.

19. The perfusion balloon catheter of claim 18 wherein a second length of the tube extends outside of the coiled support member and is looped around the coiled support member to form a plurality of adjacent loops which cooperate to form the inflatable balloon.

20. The perfusion balloon catheter of claim 19 wherein the loops form the tubular-shaped balloon having an inner diameter which is larger than an outer diameter of the coiled support member thereby forming a perfusion passage extending from a proximal end to a distal end of the balloon.

21. The perfusion balloon catheter of claim 20 and further comprising means for connecting adjacent loops of the tubular-shaped balloon.

22. The perfusion balloon catheter of claim 20 wherein the perfusion passage has an opening, upon inflation of the balloon, with a cross-sectional area of greater than about 15 percent of a total cross-sectional area of the opening and the balloon.

23. The perfusion balloon catheter of claim 16 wherein the retainer means is positioned between each loop of the tube and an inner surface of the coiled support member.

24. The perfusion balloon catheter of claim 16 wherein the opening and the inner surface of the distal end of the tubular shaft conform to accept the outer surface of the proximal end of the coiled support member, and wherein the proximal end of the coiled support member is bonded within the distal end of the tubular shaft.

25. A rapid exchange perfusion balloon catheter for use with a guide wire, the catheter comprising:

an elongated tubular shaft having a proximal end, a distal end and a lumen extending therethrough;

a tubular-shaped balloon formed by a helical coil of flexible, inflatable tube disposed at the distal end of the tubular shaft, the tube having a proximal end in fluid communication with the distal end of the shaft and having a sealed distal end, the balloon having a perfusion passage through a central region of the helical coil;

means connected to the distal end of the shaft and extending distally of the distal end of the shaft for retaining the helical coil of flexible tube in a shape of the balloon; and

guide means external to the shaft for engaging the guide wire to permit longitudinal movement of the balloon along the guide wire, the guide means associated with the means for retaining the helical coil of flexible tube.

26. The catheter of claim 25 wherein the guide means is a tube having a proximal end, a distal end and a guide wire lumen extending therethrough.

27. The catheter of claim 25 wherein a proximal end of the flexible tube is bonded within the distal end of the tubular shaft.

28. The catheter of claim 25 wherein the means for retaining the tube includes a helical wire coil around which the tube is looped to form the balloon.

29. The catheter of claim 28 wherein the guide means is positioned within the helical wire coil.

30. The catheter of claim 25 wherein the guide means is a loop of the flexible tube positioned distally of the balloon.

31. The catheter of claim 25 wherein the perfusion passage has an opening, upon inflation of the balloon, with a cross-sectional area which is greater than about 15 percent of a total cross-sectional area of the opening and the balloon.

32. A rapid exchange perfusion balloon catheter for use with a guide wire, the catheter comprising:

an elongated tubular shaft having a proximal end, a distal end and a lumen extending therethrough;

a tubular-shaped balloon formed by a helical coil of flexible, inflatable tube disposed at the distal end of the tubular shaft, the tube having a proximal end bonded within and in fluid communication with the distal end of the shaft and having a sealed distal end, the balloon having a perfusion passage through a central region of the helical coil;

means connected to the distal end of the shaft for retaining the helical coil of flexible tube in a shape of the balloon; and

guide means external to and associated with the shaft for engaging the guide wire to permit longitudinal movement of the balloon along the guide wire, wherein the guide means is a tube having a proximal end, a distal end and a guide wire lumen extending therethrough.

33. The catheter of claim 32 wherein the means for retaining the tube includes a helical wire coil around which the tube is looped to form the balloon.

34. The catheter of claim 33 wherein the guide means is positioned within the helical wire coil.

35. The catheter of claim 32 wherein the guide means is a loop of the flexible tube positioned distally of the balloon.

36. The catheter of claim 32 wherein the perfusion passage has an opening, upon inflation of the balloon, with a cross-sectional area which is greater than about 15 percent of a total cross-sectional area of the opening and the balloon.

37. A method of sustaining an opening of a blood vessel so as to allow flow of blood through the blood vessel, the method comprising:

(a) providing a perfusion balloon which includes;

an elongated tubular shaft with an inflation lumen;

an open support structure which extends distally from the distal end of the shaft; and

an inflatable balloon disposed at the distal end of the shaft and in fluid communication with the inflation lumen, the balloon being formed by a flexible, inflatable tube which is looped through the support structure to form an inflatable helical coil having a perfusion passage through a central region of the helical coil;

(b) advancing the perfusion balloon catheter into the blood vessel until the balloon is positioned at a desired location within the blood vessel; and

(c) inflating the balloon so as to cause an outer composite surface of the helical coil to expand and contact a wall of the blood vessel and thereby maintain, for an extended period, a flow of blood through the perfusion passage with the balloon inflated.

38. The method of claim 37 and further comprising:

positioning a second inflatable balloon within the central region of the helical coil;

inflating the second inflatable balloon to apply a radial outward force through the helical coil to the blood vessel; and

deflating the second inflatable balloon to allow blood flow through the perfusion passage.

39. The method of claim 37 wherein advancing the perfusion balloon catheter includes:

inserting a guide wire into the blood vessel; and

advancing the perfusion balloon catheter through the blood vessel along a path defined by the guide wire.