Balloon catheter with distal guide wire lumen

• US 5,156,594 A
• Filed: 08/28/1990
• Issued: 10/20/1992
• Est. Priority Date: 08/28/1990
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Keith, Peter T.
• Primary Examiner(s): Yasko, John D.
• Assistant Examiner(s): CERMAK, ADAM
• Application Number:
  US07/574,265
• Time in Patent Office: 784 Days
• Field of Search: 606/192, 606/194, 604/95-103, 604/282, 604/204
• US Class Current: 604/103.09
• CPC Class Codes: A61M 2025/0034 characterized by elements which are assembled, connected or fused, e.g. splittable tubes, outer sheaths creating lumina or separate cores
• CPC Class Codes: A61M 2025/0098 having a strain relief at the proximal end, e.g. sleeve
• CPC Class Codes: A61M 2025/0183 Rapid exchange or monorail catheters
• CPC Class Codes: A61M 2025/09191 made of twisted wires
• CPC Class Codes: A61M 2025/1056 having guide wire lumens outside the main shaft, i.e. the guide wire lumen is within or on the surface of the balloon
• 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 2025/1079 having radio-opaque markers in the region of the balloon
• CPC Class Codes: A61M 25/0029 characterized by features relating to least one lumen located at the middle part of the catheter, e.g. slots, flaps, valves, cuffs, apertures, notches, grooves or rapid exchange ports catheter shaft surface irregularities A61M2025/006
• CPC Class Codes: A61M 25/0032 characterized by at least one unconventionally shaped lumen, e.g. polygons, ellipsoids, wedges or shapes comprising concave and convex parts
• CPC Class Codes: A61M 25/0054 with regions for increasing flexibility
• CPC Class Codes: A61M 25/0662 Guide tubes
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

An over-the-wire balloon dilatation catheter has a stainless steel hypotube catheter shaft, an intermediate sleeve section bonded to the shaft and a distal balloon section connected to the sleeve section. The sleeve section is formed from relatively flexible polymer materials and includes an inner core tube which defines a guide wire lumen extending only through a distal portion of the catheter (including its sleeve and balloon sections) to facilitate fast balloon catheter exchanges. A distal end of the hypotube shaft is crimped laterally and the core tube is nested and bonded within the crimp to provide a proximal outlet for the guide wire lumen. The hypotube shaft provides an inflation lumen for the balloon, with the inflation lumen being continued as an annular inflation lumen through the sleeve section where an outer sleeve is bonded about the core tube and extends from the distal end of the hypotube shaft to the balloon section. A kink-resistant coil structure extends distally from the distal end of the hypotube shaft to provide a gradual change in stiffness along the length of the catheter from the relatively stiff hypotube shaft to the relatively flexible distal portion of the catheter.

Claims

1. A balloon dilatation catheter comprising:

a thin-walled, high strength metallic tube having a longitudinal inflation lumen extending therethrough from a proximal end to a distal end;

an intermediate sleeve section extending distally from the metallic tube, the sleeve section being more flexible than the metallic tube and including an inner core tube which has a longitudinal guide wire lumen extending therethrough and an outer sleeve which extends over a proximal segment of the core tube to define an annular inflation lumen between the inner core tube and the outer sleeve that is in fluid communication with the inflation lumen of the metallic tube, with the guide wire lumen having an outlet at a proximal end of the proximal segment of the core tube and with the core tube having a distal segment which extends distally beyond a distal end of the outer sleeve;

means for exposing the guide wire lumen outlet at the proximal end of the core tube to an exterior of the catheter adjacent and proximal to the distal end of the metallic tube;

an inflatable balloon extending over the distal segment of the core tube, the balloon having its proximal end connected to the distal end of the outer sleeve and having its distal end connected to the core tube so that an interior of the balloon is in fluid communication with the annular inflation lumen in the intermediate sleeve section; and

a coil member affixed about the outer sleeve of the intermediate sleeve section adjacent the distal end of the metallic tube, the coil member having its coils spaced increasingly apart as it extends distally from the metallic tube.

2. The balloon dilatation catheter of claim 1 wherein the means for exposing includes a longitudinal crimp adjacent the distal end of the metallic tube which extends laterally inwardly from one side of the metallic tube, the crimp having a proximal transition region and a distal bonding region, the proximal end of the inner core tube being nested within the distal bonding region of the longitudinal crimp of the metallic tube and bonded thereto, and with the outer sleeve extending over at least a distal portion of the bonding region and sealably affixed thereabout.

3. The balloon dilatation catheter of claim 2 wherein the metallic tube is formed from a proximal relatively long stainless steel tube and a distal relatively short stainless steel tube bonded thereto, with the longitudinal crimp being in the distal tube.

4. The balloon dilatation catheter of claim 3 wherein the outer diameter of the proximal tube is smaller than the outer diameter of the distal tube.

5. The balloon dilatation catheter of claim 1 wherein the coil member is formed from a spirally-shaped ribbon.

6. The balloon dilatation catheter of claim 1, and further comprising:

a sleeve enveloping the coil member to maintain the coil member in secured engagement to the intermediate sleeve section.

7. The balloon dilatation catheter of claim 1 wherein the metallic tube is formed from a proximal relatively long stainless steel tube and a distal relatively short stainless steel tube affixed thereto.

8. The balloon dilatation catheter of claim 7 wherein the outer diameter of the proximal tube is smaller than the outer diameter of the distal tube.

9. The balloon dilatation catheter of claim 1 wherein the outer sleeve is formed integrally with the balloon.

10. The balloon dilatation catheter of claim 1 wherein the inner core tube is formed from high density polyethylene.

11. The balloon dilatation catheter of claim 1 wherein the outer sleeve is formed from high density polyethylene.

12. The balloon dilatation catheter comprising:

a first thin-walled, high strength, relatively inflexible tube having a longitudinal inflation lumen extending therethrough from a proximal end to a distal end, the first tube having, at the distal end thereof, a longitudinal crimp extending laterally inwardly from one side of the first tube with the crimp having a proximal transition region and a distal bonding region;

a second relatively flexible core tube having a longitudinal guide wire lumen extending therethrough from a proximal end to a distal end, with the proximal end of the second tube being nested within the distal bonding region of the longitudinal crimp of the first tube and bonded thereto so that the second tube extends distally from the first tube;

a balloon assembly having an elongated proximal waist segment, an intermediate expandable segment and a distal waist segment, the proximal segment extending over at least a distal portion of the distal bonding region and sealably affixed thereabout so that the inflation lumen is in fluid communication with an interior of the balloon assembly through the proximal segment, with the balloon assembly extending distally from the distal bonding region over the second tube to a second bonding region where the distal waist segment is sealably affixed about the second tube; and

a coil member affixed about at least a proximal portion of the proximal waist segment to extend distally from the distal bonding region.

13. The balloon dilatation catheter of claim 12 wherein the coil member is formed from a spirally-shaped ribbon.

14. The balloon dilatation catheter of claim 12, wherein the coil member has its coils spaced increasingly apart as it extends distally from the first tube.

15. The balloon dilatation catheter of claim 12, and further comprising:

a sheath enveloping the coil member and maintaining the coil member about the proximal waist segment of the balloon assembly.

16. The balloon dilatation catheter of claim 12 wherein the first tube is formed from a proximal, relatively long stainless steel tube and a distal relatively short stainless steel tube bonded thereto, with the longitudinal crimp being in the distal tube.

17. The balloon dilatation catheter of claim 16 wherein the outer diameter of the proximal tube is smaller than the outer diameter of the distal tube.

18. The balloon dilatation catheter of claim 12 wherein the second tube is formed from high density polyethylene.

19. In an elongate dilatation catheter of the type that can be slidably moved along a guide wire that can extend past a distal end of the catheter, wherein the guide wire is received in a guide wire lumen of the catheter, the guide wire extending from a distal guide wire lumen opening to a proximal guide wire lumen opening disposed in a portion of the catheter that is spaced distally from a proximal end of the catheter, the dilatation catheter including an inflatable balloon and an inflation lumen extending through the catheter separate from the guide wire lumen, an improvement comprising:

a first proximal shaft section of the catheter defined by a relatively rigid metallic tube;

a second shaft section disposed distally of the first shaft section, the second shaft section being relatively more flexible than the first shaft section; and

a transition section disposed between the first shaft section and the second shaft section, the transition section including a transition member comprising a metallic element of gradually diminished dimension, the transition member extending adjacent to the proximal guide wire lumen opening, and the transition member having gradually decreasing rigidity in the distal direction to provide a relatively smooth transition between the first shaft section and the second shaft section.

20. The improved catheter of claim 19 in which the transition member is adapted to impart a tapering transition in flexibility between the relatively rigid proximal portion and the relatively more flexible second section.

21. The improved catheter of claim 19 in which the transition member extends at least in part across the guide wire lumen proximal opening.

22. The improved catheter of claim 19 in which the transition member extends at least in part distally of the guide wire lumen proximal opening.

23. The improved catheter of claim 19 in which the transition member comprises:

a coil spring located in a wall of the relatively more flexible portion of the catheter distally of the proximal lumen opening.

24. The improved catheter of claim 23 in which the coil spring is of gradually greater flexibility in a distal direction.

25. The improved catheter of claim 23 in which the coil spring is located around the guide wire lumen.

26. The improved catheter of claim 19 in which the transition member is located at least in part around the inflation lumen.

27. The improved catheter of claim 19 in which the transition member is connected to the first shaft section.

28. In an elongate dilatation catheter of the type that can be slidably moved along a guide wire that can extend past a distal end of the catheter, wherein the guide wire is received in a guide wire lumen of the catheter, the guide wire extending from a distal guide wire lumen opening to a proximal guide wire lumen opening located in a portion of the catheter that is spaced distally from a proximal end of the catheter, the dilatation catheter including an inflatable balloon and an inflation lumen extending through the catheter separate from the guide wire lumen, an improvement comprising:

a first proximal shaft section of the catheter defined by a relatively rigid metallic tube;

a second shaft section disposed distally of the first shaft section, the second shaft section being relatively more flexible than the first shaft section; and

a transition section disposed between the first shaft section and the second shaft section, the transition section including a transition member extending adjacent to the proximal guide wire lumen opening, the transition member having gradually decreasing rigidity in the distal direction to provide a relatively smooth transition between the first section of the shaft and the second section of the shaft.

29. The improved catheter of claim 28 in which the transition member is adapted to impart a tapering transition in flexibility between the relatively rigid first section and the relatively more flexible second section of the shaft.

30. The improved catheter of claim 28 in which the transition member extends at least in part across the guide wire lumen proximal opening.

31. The improved catheter of claim 28 in which the transition member extends at least in part distally of the guide wire lumen proximal opening.

32. The improved catheter of claim 28 in which the transition member extends at least in part around the inflation lumen.

33. The improved catheter of claim 28 in which the transition member is connected to the first shaft section.

34. A balloon dilatation catheter comprising:

a metallic tube defining a first shaft section having a proximal end and a distal end;

a second shaft section, more flexible than the metallic tube, disposed distally of the first shaft section;

the first and second shaft sections having an inflation lumen defined therethrough which extends from the proximal end of the metallic tube to the distal end of the second shaft section;

a dilatation balloon attached to the distal end of the second shaft section, the dilatation balloon being in fluid communication with the inflation lumen such that inflation pressure may be provided to the balloon therethrough;

a transition section interposed between the first shaft section and the second shaft section, the transition section including a transition member including a crimp defining the proximal guide wire outlet and configured to provide stiffness which gradually decreases distally from the stiffness of the first shaft section to the stiffness of the second shaft section; and

a guide wire tube extending through the interior of the balloon, the guide wire tube defining a second separate and shorter lumen than the inflation lumen, the second lumen having a proximal guide wire opening at its proximal end and a distal guide wire opening at its distal end, with the proximal guide wire opening being disposed adjacent the distal end of the first shaft section, and wherein the second lumen receives a guide wire therein such that the catheter may be slidably moved on the guide wire.

35. The catheter of claim 34 wherein the transition member comprises a metallic element of gradually diminished dimension.

36. The catheter of claim 34 wherein the transition member extends at least in part across the guide wire lumen proximal opening.

37. The catheter of claim 34 wherein the transition member extends at least in part distally of the guide wire lumen proximal opening.

38. The catheter of claim 34 wherein the transition member is adapted to impart a tapering transition in flexibility between the metallic tube of the first shaft section and the more flexible second shaft section.

39. The catheter of claim 34 wherein the transition member extends at least in part around the inflation lumen.

40. In an elongate dilatation catheter which has an inflatable balloon and an inflation lumen extending through the catheter, wherein the catheter is of the type that can be slidably moved along a guide wire that can extend past a distal end of the catheter through a guide wire lumen of the catheter, wherein the guide wire lumen is separate from the inflation lumen and extends from a distal guide wire lumen opening to a proximal guide wire lumen opening located in a portion of the catheter that is spaced distally from a proximal end of the catheter so that the guide wire lumen is shorter than the inflation lumen, an improvement comprising:

a first proximal shaft section of the catheter defined by a relatively rigid metallic tube;

a second shaft section disposed distally of the first shaft section, the second shaft section being relatively more flexible than the first shaft section; and

a transition section disposed between the first shaft section and the second shaft section, the transition section including a transition member comprising a metallic element of gradually diminished dimension, the transition member extending adjacent to the proximal guide wire lumen opening, and the transition member having gradually decreasing rigidity in the distal direction to provide a relatively smooth transition between the first shaft section and the second shaft section.

41. The improved catheter of claim 40 in which the transition member is adapted to impart a tapering transition in flexibility between the relatively rigid proximal portion and the relatively more flexible distal portion.

42. The improved catheter of claim 40 in which the transition member extends at least in part across the guide wire lumen proximal opening.

43. The improved catheter of claim 40 in which the transition member extends at least in part distally of the guide wire lumen proximal opening.

44. The improved catheter of claim 40 in which the transition member extends at least in part around the inflation lumen.

45. The improved catheter of claim 40 in which the transition member is connected to the first shaft section.

46. In an elongate dilatation catheter which has an inflatable balloon and an inflation lumen extending through the catheter, wherein the catheter is of the type that can be slidably moved along a guide wire which can extend past a distal end of the catheter through a guide wire lumen of the catheter, wherein the guide wire lumen is separate from the inflation lumen and extends from a distal guide wire lumen opening to a proximal guide wire lumen opening disposed in a portion of the catheter that is spaced distally from a proximal end of the catheter so that the guide wire lumen is shorter than the inflation lumen, an improvement comprising:

a first proximal shaft section of the catheter defined by a relatively rigid metallic tube;

a second shaft section disposed distally of the first shaft section, the second shaft section being relatively more flexible than the first shaft section; and

a transition section disposed between the first shaft section and the second shaft section, the transition section including a transition member extending adjacent to the proximal guide wire lumen opening, the transition member having gradually decreasing rigidity in the distal direction to provide a relatively smooth transition between the first section of the shaft and the second section of the shaft.

47. The improved catheter of claim 46 in which the transition member is adapted to impart a tapering transition in flexibility between the relatively rigid proximal portion and the relatively more flexible distal portion.

48. The improved catheter of claim 46 in which the transition member extends at least in part across the guide wire lumen proximal opening.

49. The improved catheter of claim 46 in which the transition member extends at least in part distally of the guide wire lumen proximal opening.

50. The improved catheter of claim 46 in which the transition member extends at least in part around the inflation lumen.

51. The improved catheter of claim 46 in which the transition member is connected to the first shaft section.

52. In an elongate dilatation catheter of the type that has a first relatively long proximal shaft section, a second shorter distal shaft section disposed distally of the first shaft section, an inflatable balloon attached to the distal end of the second shaft section wherein the first and second shaft sections have an inflation lumen defined therethrough so that the balloon is in fluid communication with the inflation lumen, and wherein the catheter is of the type that can be slidably moved along a guide wire which can extend through a guide wire lumen of the catheter, the guide wire lumen being separate from the inflation lumen and extending from a distal guide wire lumen opening at the distal end of the catheter to a proximal guide wire lumen opening adjacent the proximal end of the second shaft section so that the guide wire lumen is shorter than the inflation lumen, an improvement comprising:

the first proximal shaft section of the catheter defined by a relatively rigid metallic tube;

the second shaft section of the catheter being relatively more flexible than the metallic tube and having a relatively short reinforced proximal portion and a relatively long non-reinforced distal portion, and

the reinforced proximal portion including a transition member disposed adjacent to the proximal lumen opening and extending distally along the second shaft section to provide a reinforcement therefor, the transition member including a metallic element which decreases gradually in dimension as it extends distally along the catheter to provide gradually decreasing rigidity in the distal direction, the transition member having a distal terminal end spaced from the balloon by the length of the non-reinforced distal portion of the second shaft section.

53. The improved catheter of claim 52 wherein the transition member is adapted to impart a tapering transition in flexibility between the relatively rigid first shaft section and the relatively more flexible second shaft section.

54. The improved catheter of claim 52 wherein the transition member is located at least in part around the inflation lumen.

55. The improved catheter of claim 52 wherein the transition member extends at least in part across the guide wire lumen proximal opening.

56. The improved catheter of claim 52 wherein the transition member extends at least in part distally of the guide wire lumen proximal opening.