Helically grooved balloon for dilatation catheter and method of using

• US 5,545,132 A
• Filed: 12/21/1993
• Issued: 08/13/1996
• Est. Priority Date: 12/21/1993
• Status: Expired due to Fees

• Current Assignee: Medtronic Ave Incorporated (Medtronic Plc)
• Original Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Inventors: Fagan, John R., Kling, Jeffrey
• Primary Examiner(s): YASKO JR, JOHN D
• Application Number:
  US08/171,061
• Time in Patent Office: 966 Days
• Field of Search: 604/96, 604/101, 604/52, 604/53, 604/280-282, 604/264, 606/191, 606/194, 606/195
• US Class Current: 604/103.08
• CPC Class Codes: A61M 2025/1086 having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves
• 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

Abstract

A dilatation balloon having at least one helical groove disposed in at least a portion of the dilating surface of the dilatation balloon is mounted on the distal end of a catheter shaft. Multiple helical grooves may be provided in the dilatation balloon extending parallel to each other or opposite to each other in the dilating surface. Each helical groove has a pitch, width and depth. According to one aspect of the invention, the pitch, width and depth of the helical groove, as well as the number of grooves, are selected to allow perfusion of blood past the dilatation catheter when the dilatation balloon is inflated in a blood vessel. According to another aspect of the invention, the pitch, width, and depth of the helical groove, as well as the number of grooves, are selected so that the dilatation balloon conforms to a tortuous blood vessel and does not straighten the blood vessel during dilation. According to another aspect of the invention, the pitch, width, and depth of the helical groove, as well as the number of grooves, are selected to control the diametrical compliance of the dilatation balloon. The pitch, width, and depth of the helical groove may be selected to provide both conformance to the shape of tortuous blood vessels and diametrical compliance. The helical groove also permits the dilatation balloon to deflate without "winging", i.e., forming undesirable flat folds that extend outward from the rest of the catheter.

Claims

1. A method of dilating a blood vessel with a dilatation catheter comprising the steps of:

positioning in the blood vessel a dilatation catheter having a limited compliance dilatation balloon dimensioned to dilate the lumen of the blood vessel when inflated, the balloon having a dilating surface and including at least one helical groove disposed in at least a portion of the dilating surface, the portion of the balloon that defines the groove being constructed to deflect and cause the groove to diminish in depth with increased inflation pressure to enable the effective dilating diameter of the balloon to increase within a limited range of diameters; and

inflating the limited compliance dilatation balloon to dilate the blood vessel.

2. The method of claim 1 further comprising a step of varying the diameter of the limited compliance dilatation balloon by varying the pressure of an inflation fluid in the dilatation balloon.

3. The method of claim 2, wherein the diameter of the limited compliance dilatation balloon varies as a linear function of the pressure until a predetermined maximum diameter is reached.

4. The method of claim 3 wherein the limited compliance dilatation balloon is constructed of a substantially non-compliant material.

5. The method of claim 4, wherein the material is polyethylene terephthalate.

6. The method of claim 1 wherein the blood vessel is curved and wherein the limited compliance dilatation balloon, when inflated, conforms to the curvature of the blood vessel and dilates the blood vessel without straightening the blood vessel.

7. The method of claim 3, further comprising the step of providing perfusion of blood through the helical groove during dilation of the blood vessel.

20. The dilatation catheter of either one of claims 8 or 5 wherein at least one of the pitch, width and depth of the at least one helical groove varies over the dilating surface of the limited compliance dilatation balloon.

63. A method of dilating a blood vessel as defined in claim 1 wherein the balloon includes only a single helical groove.

69. A method dilating blood vessel with the dilatation catheter is defined in claim 1 wherein at least one of the pitch, width and depth of the least one helical groove varies over the dilating surface of the limited compliance dilatation balloon.

8. A dilatation catheter comprising:

a catheter shaft having a distal end;

a limited compliance dilatation balloon mounted on the distal end of the catheter shaft, the balloon being dimensioned to dilate a lumen of a blood vessel when inflated;

the balloon having a dilating surface and including at least one helical groove disposed in at least a portion of the dilating surface of the balloon wherein the at least one helical groove includes at least one of a pitch, width and depth selected to facilitate deflection and reduction in the depth of the groove with increased inflation pressure to enable the diameter of the balloon to increase, thereby to control the effective dilating diameter of the balloon.

9. The dilatation catheter of claim 8 wherein the at least one helical groove is disposed in at least one selected portion of the dilating surface of the balloon to provide a zone of diametrical compliance only in the selected portion.

10. The dilatation catheter of claim 9 wherein the at least one helical groove is disposed in each of a plurality of selected portions of the dilating surface of the balloon to provide a plurality of zones of diametrical compliance.

11. The dilatation catheter of claim 8, wherein at diameters less than a predetermined maximum diameter of the limited compliance dilatation balloon, the diameter of the limited compliance dilatation balloon is a linear function of inflation pressure.

12. The dilatation catheter of claim 11 wherein the pitch and depth of the at least one helical groove are such that increasing at least one of them increases the diametrical compliance of the balloon and wherein decreasing at least one of them decreases the diametrical compliance of the limited compliance dilatation balloon.

13. The dilatation catheter of claim 12 wherein the pitch and depth of the at least one helical groove are such that decreasing its width increases the diametrical compliance of the balloon and wherein increasing its width decreases the diametrical compliance of the balloon.

14. The dilatation catheter of claim 13, wherein the at least one helical groove includes multiple helical grooves.

15. The dilatation catheter of claim 14 wherein the helical grooves are constructed such that increasing their number increases the diametrical compliance of the balloon and decreasing their number decreases the diametrical compliance of the balloon.

16. The dilatation catheter of claim 13, wherein the multiple helical grooves extend parallel to each other in the dilating surface.

17. The dilatation catheter of claim 13, wherein the multiple helical grooves are not parallel to each other in the dilating surface.

18. The dilatation catheter of any one of claims 8-17 wherein the balloon is constructed of a substantially non-compliant material.

19. The dilatation catheter of claim 18, wherein the material is polyethylene terephthalate.

64. A dilatation catheter as defined in claim 8 wherein the balloon includes only a single helical groove.

21. A limited compliance dilatation catheter balloon having a dilating surface, comprising:

at least one helical groove disposed in at least a portion of the dilating surface of the balloon wherein the pitch, width and depth of the at least one helical groove is selected to facilitate deflection and reduction in the depth of the groove with increased inflation pressure to enable the diameter to increase thereby to compliantly control the effective dilating diameter of the balloon.

22. The limited compliance dilatation catheter balloon of claim 21, wherein the at least one helical groove is disposed in at least one selected portion of the dilating surface of the balloon to provide a zone of diametrical compliance only in the selected portion.

23. The limited compliance dilatation catheter balloon of claim 22 wherein the at least one helical groove is disposed in each of a plurality of selected portions of the dilating surface of the balloon to provide a plurality of zones of diametrical compliance.

24. The limited compliance dilatation catheter balloon of claim 21, wherein at diameters less than a predetermined maximum diameter of the limited compliance dilatation catheter balloon, the diameter of the limited compliance dilatation catheter balloon is a linear function of inflation pressure.

25. The limited compliance dilatation catheter balloon of claim 24 wherein the pitch and depth of the at least one helical groove are such that increasing at least one of them increases the diametrical compliance of the balloon and wherein decreasing at least one of them decreases the diametrical compliance of the balloon.

26. The limited compliance dilatation catheter balloon of claim 25 wherein the pitch and depth of the at least one helical groove are such that decreasing its width increases the diametrical compliance of the balloon and wherein increasing its width decreases the diametrical compliance of the balloon.

27. The limited compliance dilatation catheter balloon of claim 26 wherein the balloon includes multiple helical grooves.

28. The limited compliance dilatation catheter balloon of claim 27 wherein the helical grooves are constructed such that increasing their number increases the diametrical compliance of the balloon and decreasing their number decreases the diametrical compliance of the balloon.

29. The limited compliance dilatation catheter balloon of claim 27, wherein the multiple helical grooves extend parallel to each other in the dilating surface.

30. The limited compliance dilatation catheter balloon of claim 27, wherein the multiple helical grooves are not parallel to each other in the dilating surface.

31. The dilatation catheter balloon of any one of claims 21-30 wherein the balloon is constructed of a substantially non-compliant material.

32. The limited compliance dilatation catheter balloon of claim 31 wherein the material comprises polyethylene terephthalate.

65. A limited compliance dilatation catheter balloon as defined in claim 21 wherein the balloon includes only a single helical groove.

33. A method of dilating a blood vessel with a dilatation catheter comprising the steps of:

positioning a dilatation catheter having a deflated limited compliance dilatation balloon adapted to dilate a lumen of a blood vessel when inflated, the balloon including at least one helical groove disposed in at least a portion of a dilating surface of the balloon, the groove being constructed to deflect and diminish in depth with increased inflation pressure to enable the diameter of the balloon to increase and enable the balloon to be substantially free of flat folds when deflated; and

inflating the limited compliance dilatation balloon to dilate the blood vessel.

34. The method of claim 33 further comprising a step of varying a diameter of the balloon by varying the pressure of an inflation fluid in the dilatation balloon.

35. The method of claim 34, wherein the diameter of the limited compliance dilatation balloon varies as a linear function of the pressure until a predetermined maximum diameter is reached.

36. The method of claim 35 wherein the balloon is constructed of a substantially non-compliant material.

37. The method of claim 33 wherein the blood vessel is curved and wherein the balloon, when inflated, conforms to the curvature of blood vessel and dilates the blood vessel without straightening the blood vessel.

66. A method of dilating a blood vessel with a dilatation catheter as defined in claim 33 wherein the balloon has only a single helical groove.

70. A method of dilating a blood vessel with dilatation catheter is defined in claim 33 wherein at least one of the pitch, width and depth of the at least one helical groove varies over the dilating service of the balloon.

38. A dilatation catheter comprising:

a catheter shaft having a distal end;

a limited compliance dilatation balloon mounted on the distal end of the catheter shaft, the balloon having a dilating surface and being adapted to dilate the lumen of a blood vessel when inflated;

the dilating surface of the balloon including at least one helical groove disposed in at least a portion of the dilating surface wherein the pitch and depth of the helical groove is selected to facilitate deflection and reduction in the depth of the groove with increased inflation pressure to enable the diameter to increase thereby to control the effective dilating diameter of the balloon

the balloon, when deflated, being substantially free of flat folds.

39. The dilatation catheter of claim 38 wherein the at least one helical groove is disposed in at least one selected portion of the dilating surface of the balloon to provide a zone of diametrical compliance only in the selected portion.

40. The dilatation catheter of claim 39 wherein the at least one helical groove is disposed in multiple selected separate portions of the dilating surface of the balloon to provide a respective zone of diametrical compliance in each of the selected separate portions.

41. The dilatation catheter of claim 38 wherein at diameters less than a predetermined maximum diameter of the balloon, the diameter of the balloon is a linear function of inflation pressure.

42. The dilatation catheter of claim 41 wherein the pitch and depth of the at least one helical groove are such that increasing at least one of them increases the diametrical compliance of the balloon and wherein decreasing at least one of them decreases the diametrical compliance of the balloon.

43. The dilatation catheter of claim 42 wherein the pitch and depth of the at least one helical groove are such that decreasing its width increases the diametrical compliance of the balloon and wherein increasing its width decreases the diametrical compliance of the balloon.

44. The dilatation catheter of claim 43 wherein there are multiple helical grooves.

45. The dilatation catheter of claim 43 wherein increasing the number of helical grooves increases the diametrical compliance of the balloon and decreasing the number of helical grooves decreases the diametrical compliance of the balloon.

46. The dilatation catheter of claim 44 wherein the multiple helical grooves extend parallel to each other in the dilating surface.

47. The dilatation catheter of claim 44 wherein the multiple helical grooves are not parallel to each other in the dilating surface.

48. The dilatation catheter of any one of claims 38-47 wherein the limited compliance dilatation balloon is constructed of a material that is substantially non-compliant.

49. The dilatation catheter of claim 48 wherein the material is polyethylene terephthalate.

51. The dilatation catheter of either one of claims 38 or 50 wherein at least one of the pitch, width and depth of the at least one helical groove varies over the dilating surface of the balloon.

53. The limited compliance dilatation catheter balloon of claim 51 wherein the at least one helical groove is disposed in multiple selected separate portions of the dilating surface of the balloon to provide a respective zone of diametrical compliance in each of the selected separate portions.

67. A dilatation catheter as defined in claim 38 wherein the balloon has only a single helical groove.

50. A limited compliance dilatation catheter balloon adapted to dilate a blood vessel lumen when inflated and having a dilating surface, comprising:

at least one helical groove disposed in at least a portion of the dilating surface of the balloon, the at least one helical groove having at least one of a pitch, width and depth selected to control the diametrical compliance of the balloon;

the at least one groove enabling the balloon to be substantially free of flat folds when the balloon is deflated.

52. The limited compliance dilatation catheter balloon of claim 50 wherein the at least one helical groove is disposed in at least one selected portion of the dilating surface of the balloon to provide a zone of diametrical compliance only in the selected portion.

54. The limited compliance dilatation catheter balloon of claim 50 wherein at diameters less than a predetermined maximum diameter of the balloon, the diameter of the balloon is a linear function of inflation pressure.

61. The dilatation catheter balloon of any one of claims 50-60 wherein the balloon is constructed of a substantially non-compliant material.

62. The limited compliance dilatation catheter balloon of claim 61, wherein the material in polyethylene terephthalate.

68. A limited compliance dilatation catheter balloon as defined in claim 50 wherein the balloon includes only a single helical groove.

55. The limited compliance dilatation catheter balloon of claim 55 wherein the pitch and depth of the at least one helical groove are such that increasing at least one of them increases the diametrical compliance of the balloon and wherein decreasing at least one of them decreases the diametrical compliance of the balloon.

56. The limited compliance dilatation catheter balloon of claim 55 wherein the pitch and depth of the at least one helical groove are such that decreasing its width increases the diametrical compliance of the balloon and wherein increasing its width decreases the diametrical compliance of the balloon.

57. The limited compliance dilatation catheter balloon of claim 56, wherein the at least one helical groove includes multiple helical grooves.

58. The limited compliance dilatation catheter balloon of claim 57 wherein increasing the number of helical grooves increases the diametrical compliance of the balloon and decreasing the number of the helical grooves decreases the diametrical compliance of the balloon.

59. The limited compliance dilatation catheter balloon of claim 57, wherein the multiple helical grooves extend parallel to each other in the dilating surface.

60. The limited compliance dilatation catheter balloon of claim 57, wherein the multiple helical grooves are not parallel to each other in the dilating surface.