Dilatation balloon catheter and method of manufacturing

• US 5,156,595 A
• Filed: 12/23/1991
• Issued: 10/20/1992
• Est. Priority Date: 12/28/1989
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Adams, Daniel O.
• Primary Examiner(s): Bahr, Robert
• Assistant Examiner(s): DVORAK, LINDA C
• Application Number:
  US07/814,246
• Time in Patent Office: 302 Days
• Field of Search: 604/93, 604/96, 604/101, 604/102, 606/191, 606/194
• US Class Current: 606/194
• 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 2025/1093 having particular tip characteristics
• CPC Class Codes: A61M 25/1027 Making of balloon catheters
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

An angioplasty catheter has a one-piece, flexible elongated tube in which a hollow proximal section tapers to form a solid distal core with a solid cross-section. The core further tapers to form a safety wire at the distal end of the catheter. An inflatable balloon circumscribes the elongated tube and the interior of the balloon is in fluid communication with a lumen defined by the hollow proximal section of the tube through at least one aperture extending through the tube wall and into the balloon interior. A coil spring extends distally from the balloon about the solid distal core and safety wire, with the safety wire secured to an end cap of the coil spring.

Claims

1. An angioplasty catheter, comprising:

a single element, longitudinally extending flexible shaft which has a proximal section and a distal section, the proximal section having an inflation lumen extending longitudinally therethrough and the distal section having a proximal transition portion and a distal core portion, with the transition portion having a distally decreasing outer diameter and the distal core portion having a solid cross section; and

a balloon circumscribing the shaft which has a proximal segment, an intermediate inflatable segment, and a distal segment, the proximal segment being sealably connected to the shaft, the distal segment being sealably connected to the distal core portion of the distal section of the shaft and the intermediate segment beginning distally of the proximal transition portion of the distal section of the shaft and in fluid communication with the inflation lumen.

2. The angioplasty catheter of claim 1, and further comprising:

a flexible tip extending from the distal core portion of the distal section of the shaft.

3. The angioplasty catheter of claim 2, wherein the flexible tip is mounted to the distal core portion adjacent the distal segment of the balloon.

4. The angioplasty catheter of claim 2, wherein the flexible tip is soldered to the distal core portion of the distal section of the shaft.

5. The angioplasty catheter of claim 2, wherein the flexible tip is a coil spring tip.

6. The angioplasty catheter of claim 5, wherein the single element shaft tapers at the transition portion to form a safety wire attached to an end cap of the coil spring tip.

7. The angioplasty catheter of claim 1, wherein the transition portion tapers uniformly from a proximal end of the transition portion to a distal end of the transition portion.

8. The angioplasty catheter of claim 1, wherein the shaft is formed from a stainless steel hypotube.

9. The angioplasty catheter of claim 1, wherein the shaft is coated with a lubricous material.

10. The angioplasty catheter of claim 1, wherein the shaft is formed from semi-rigid plastic tubing.

11. The angioplasty catheter of claim 10, wherein the transition portion of the distal section of the shaft tapers uniformly to the distal core portion and wherein the distal core portion of the distal section of the shaft is formed about a metal core wire.

12. The angioplasty catheter of claim 11, wherein a diameter of the metal core wire decreases distally to form a safety wire.

13. The angioplasty catheter of claim 1, wherein the shaft has at least one aperture through its transition portion to provide fluid communication between the inflation lumen and the intermediate inflatable segment of the balloon.

14. The angioplasty catheter of claim 1, wherein the balloon is formed from a polymeric material.

15. The angioplasty catheter of claim 1, wherein a radiopaque marker band circumscribes a portion of the shaft within the balloon.

16. The angioplasty catheter of claim 1, wherein the proximal and distal segments of the balloon are bonded to the shaft with epoxy.

17. The angioplasty catheter of claim 1, and further comprising:

a bond between the transition portion and the proximal segment of the balloon such that the outer diameter of the catheter remains generally uniform.

18. An angioplasty catheter, comprising:

a single element, longitudinally extending flexible shaft which has a proximal section and a distal section, the proximal section having an inflation lumen extending longitudinally therethrough and the distal section having a proximal transition portion and a distal core portion, with the transition portion having a distally decreasing outer diameter and the distal core portion having a solid cross section; and

a balloon circumscribing the shaft which has a proximal segment, an intermediate inflatable segment, and a distal segment, the proximal segment being sealably connected to the shaft, the distal segment being sealably connected to the distal core portion of the distal section of the shaft and the intermediate segment beginning distally of the proximal transition portion of the distal section of the shaft and in fluid communication with the inflation lumen.

a wire portion formed in the distal core portion of the distal section of the shaft with the wire portion being of reduced diameter from the distal core portion and extending distally thereof; and

a flexible coil spring mounted on the distal core portion of the distal section of the shaft to extend about the wire portion, with the coil spring secured to a distal end of the wire portion.

19. A method of manufacturing an angioplasty balloon catheter which comprises the steps of:

forming a single element shaft having an inflation lumen and a proximal section and a distal section;

forming a proximal part of the distal section of the shaft into a transition portion wherein the cross-sectional diameter of the shaft is reduced distally;

forming a distal part of the distal section into a generally solid distal core;

mounting an inflatable balloon on the distal section of the shaft, with a proximal segment of the balloon secured to the shaft, with a distal segment of the balloon secured to the generally solid distal core, and with an intermediate inflatable segment of the balloon beginning distally of the proximal transition portion of the distal section of the shaft; and

providing a means of fluid communication between the balloon and the inflation lumen.

20. The method of claim 19, and further comprising the steps of:

forming the solid distal core into a solid distal core wire; and

further reducing the cross-sectional diameter of the solid distal core wire to define a distal safety wire segment of the shaft.

21. The method of claim 20, and further comprising the step of:

securing a coil spring to the solid distal core wire to extend distally from the balloon about the distal safety wire segment.

22. The method of claim 21, and further comprising the step of:

securing a distal end of the distal safety wire segment to a distal end cap mounted on the coil spring.

23. The method of claim 19, and further comprising the step of:

uniformly decreasing the cross-sectional diameter of the transition portion of the shaft distally.

24. The method of claim 19, and further comprising the step of:

bonding the proximal segment of the balloon to the transition portion such that the overall diameter of the catheter remains generally uniform.

25. The method of claim 19, and further comprising the step of:

providing at least one aperture for fluid communication between the balloon and the inflation lumen.

34. The angioplasty catheter of claim 23, wherein the intermediate inflatable segment of the balloon is distal of the proximal transition portion of the distal section of the shaft.

35. The angioplasty catheter of claim 23 wherein the proximal transition portion includes at least one aperture through a side wall thereof to provide fluid communication between the inflation lumen and the intermediate inflatable segment of the balloon.

26. A method of manufacturing an angioplasty balloon catheter which comprises the steps of:

forming a single element shaft having an inflation lumen and a proximal section and a distal section;

forming a proximal transition portion from the distal section of the shaft wherein the cross-sectional diameter of the shaft is reduced distally;

forming a distal core portion of the distal section of the shaft into a metal core wire;

mounting an inflatable balloon on the distal section of the shaft, with a proximal segment of the balloon secured to the shaft, a distal segment of the balloon secured to the distal core portion and an intermediate inflatable segment beginning distally of the proximal transition portion of the distal section of the shaft; and

providing a means of fluid communication between the intermediate inflatable segment of the balloon and the inflation lumen.

27. The method of claim 26, and further comprising the step of:

further reducing the cross-sectional diameter of the metal core wire to define a distal safety wire segment of the shaft.

28. The method of claim 27, and further comprising the step of:

securing a coil spring to the metal core wire to extend distally from the balloon about the distal safety wire segment.

29. The method of claim 28, and further comprising the step of:

securing a distal end of the distal safety wire segment to a distal end cap mounted on the coil spring.

30. The method of claim 26, and further comprising the step of:

uniformly decreasing the cross-sectional diameter of the transition portion of the shaft distally.

31. The method of claim 26, and further comprising the step of:

bonding the proximal segment of the balloon to the transition portion such that the overall diameter of the catheter remains generally uniform.

32. The method of claim 26, and further comprising the step of:

providing at least one aperture for fluid communication between the intermediate inflatable segment and the inflation lumen.

33. An angioplasty catheter, comprising:

a longitudinal extending flexible shaft which has a proximal section and a distal section, the proximal section having an inflation lumen extending longitudinally therethrough and the distal section comprising a single element having a proximal transition portion and a distal core portion, with the transition portion providing a distally decreasing shaft outer diameter and the distal core portion having a solid cross section; and

a balloon circumscribing the shaft having a proximal segment, an intermediate inflatable segment, and a distal segment, the proximal segment being sealably connected to the shaft, the distal segment being sealably connected to the distal core portion of the distal section of the shaft and the intermediate segment being in fluid communication with the inflation lumen.

36. The angioplasty catheter of claim 33 and further comprising:

a flexible tip extending from the distal core portion of the distal section of the shaft.

37. The angioplasty catheter of claim 36 wherein the flexible tip is mounted to the distal core portion adjacent the distal segment of the balloon.

38. The angioplasty catheter of claim 36 wherein the flexible tip is soldered to the distal core portion of the distal section of the shaft.

39. The angioplasty catheter of claim 36 wherein the flexible tip is a coil spring tip.

40. The angioplasty catheter of claim 39 including a safety wire extending from the distal core portion of the shaft and attached to an end cap of the coil spring tip.

41. The angioplasty catheter of claim 33 wherein the transition portion tapers uniformly from a proximal end of the transition portion to a distal end of the transition portion.

42. The angioplasty catheter of claim 33 wherein the shaft is form from a stainless steel hypotube.

43. The angioplasty catheter of claim 33 wherein the shaft is coated with a lubricous material.

44. The angioplasty catheter of claim 33 wherein the shaft is formed from semi-rigid plastic tubing.

45. The angioplasty catheter of claim 44 wherein the transition portion of the distal section of the shaft tapers uniformly to the distal core portion and wherein the distal core portion of the distal section of the shaft is formed about a metal core wire.

46. The angioplasty catheter of claim 45 wherein a diameter of the metal core wire decreases distally to form a safety wire.

47. The angioplasty catheter of claim 33 wherein the proximal and distal segments of the balloon are bonded to the shaft with an epoxy.

48. The angioplasty catheter of claim 33 wherein the proximal segment of the balloon is formed of a flexible plastic tube having a proximal end sealably connected to the shaft and a distal end sealably connected to a proximal end of the inflatable balloon segment.

49. The angioplasty catheter wherein an elongated shaft supports an inflatable balloon at a distal end thereof, the improvement comprising:

a shaft including a proximal section having an inflation lumen therethrough, the inflation lumen being in fluid communication with an interior of the balloon, and a distal section, the distal section comprising a single element having a proximal transition portion and a distal core portion extending through the interior of the balloon, with the transition portion providing a distally decreasing shaft outer diameter and the distal core portion having a solid cross section terminating the inflation lumen.