Large lumen balloon catheter

• US 6,702,782 B2
• Filed: 06/26/2001
• Issued: 03/09/2004
• Est. Priority Date: 06/26/2001
• Status: Expired due to Term

• Current Assignee: Stryker Corporation
• Original Assignee: Concentric Medical, Inc. (Stryker Corporation)
• Inventors: Miller, John, Pierce, Ryan, Aboytes, Maria, Dieck, Martin
• Primary Examiner(s): Lazarus, Ira S.
• Assistant Examiner(s): NGUYEN, CAMTU TRAN
• Application Number:
  US09/892,349
• Publication Number:
  US 20020198491A1
• Time in Patent Office: 987 Days
• Field of Search: 604/96.01, 604/93.01, 604/97.01, 604/99.01, 604/164.1, 604/164.13, 604/523, 604/528, 606/191, 606/194, 285/123.15, 285/123.1, 285/124.1, 285/222.1, 285/136.1, 138/111-114, 138/116, 138/122, 138/130, 138/132, 138/123
• US Class Current: 604/96.01
• 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 2025/0036 with more than four lumina
• CPC Class Codes: A61M 2025/0039 characterized by lumina being arranged coaxially
• CPC Class Codes: A61M 2025/004 characterized by lumina being arranged circumferentially
• CPC Class Codes: A61M 2025/1052 for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 2210/0693 Brain, cerebrum
• CPC Class Codes: A61M 25/003 characterized by features relating to least one lumen located at the distal part of the catheter, e.g. filters, plugs or valves catheter tips A61M25/0067
• CPC Class Codes: A61M 25/005 with embedded materials for reinforcement, e.g. wires, coils, braids
• CPC Class Codes: A61M 25/0053 having a variable stiffness along the longitudinal axis, e.g. by varying the pitch of the coil or braid
• CPC Class Codes: A61M 25/0054 with regions for increasing flexibility
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00

Abstract

This is a balloon catheter having at least two lumens. One of the lumens is a large working lumen. The balloon catheter is especially useful as a guide catheter and may be used in a variety of therapeutic and diagnostic procedures. In particular, it has value in treating neurovascular embolic strokes in combination with other devices which are delivered to the stroke site through that working lumen. The remainder of the lumens typically are used to inflate and to deflate the balloon. It is highly preferable that the balloon or inflatable member be situated in a recess in the outer wall of the inventive catheter. Additionally, the distal end of the catheter past the balloon is preferably tapered. The catheter has a very low profile as compared to other catheters of the neurovascular balloon catheter genre. It may include other features such as variable stiffness along the axis of the device and anti-kinking components. The balloon is preferably compliant in nature.

When intended for use in treating embolic stroke, the catheter may be a component of a kit including a foreign body retriever. Further, amongst other procedures, the invention includes methods of temporarily blocking a vascular lumen, of removing neurovascular or peripheral emboli. Other procedures, where diagnosis or treatment is needed in a vascular space and a large working lumen is desired, are suitable procedures for the balloon catheter.

Claims

1. A balloon catheter comprising:

a first elongate tubular member having an outer surface, a proximal end, a distal end, having a substantial constant diameter, a working lumen extending between said distal and proximal ends and being open at said distal end, and a radially recessed region near the distal end, and

a longitudinally stretched inflatable member situated within said radially recessed region providing said substantially constant diameter and being fluid-connectable with at least one fluid supply lumen independent of said working lumen.

2. The balloon catheter of claim 1, further comprising a second elongate tubular member substantially concentric with the first elongate tubular member and having a lumen forming the working lumen and an outer surface forming an annular space between the first elongate tubular member, said annular space being the fluid supply lumen.

3. The balloon catheter of claim 2, wherein said second elongate tubular member comprises a wall, a distal end, and a proximal end, and further comprising a stiffener member situated to provide kink resistance to the balloon catheter.

4. The balloon catheter of claim 3, wherein the stiffener member comprises a coil.

5. The balloon catheter of claim 3, where the stiffener member comprises a braid.

6. The balloon catheter of claim 2, where the second elongate tubular member has varying stiffness between said distal and said proximal end.

7. The balloon catheter of claim 6 comprising segments of polymers of different stiffness.

8. The balloon catheter of claim 1 where the inflatable member is compliant.

9. The balloon catheter of claim 1 where the inflatable member is stretched longitudinally at least 10% upon attachment to the first elongate tubular member.

10. The balloon catheter of claim 9 wherein the inflatable member is stretched longitudinally about 15% upon attachment to the first elongate tubular member.

11. The balloon catheter of claim 1 where the first elongate tubular member comprises a wall containing one or more fluid supply lumens for said inflatable member.

12. The balloon catheter of claim 11 wherein said wall comprises tubing forming fluid supply lumens.

13. The balloon catheter of claim 12 wherein the wall comprises tubing spirally embedded in said wall.

14. The balloon catheter of claim 13 wherein the wall comprises square tubing spirally embedded in said wall.

15. The balloon catheter of claim 13 wherein the wall comprises round tubing spirally embedded in said wall.

16. The balloon catheter of claim 13 where said tubing comprises polymeric tubing.

17. The balloon catheter of claim 13 where the tubing comprises metallic tubing.

18. The balloon catheter of claim 17 where said metallic tubing comprises a superelastic alloy.

19. The balloon catheter of claim 12 wherein said fluid supply lumen is comprised of a braid of square or round tubing embedded in said wall.

20. The balloon catheter of claim 19 where the braid comprises square tubing.

21. The balloon catheter of claim 19 where the braid comprises round tubing.

22. The balloon catheter of claim 19 wherein said braid comprises polymeric tubing.

23. The balloon catheter of claim 19 where the braid comprises metallic tubing.

24. The balloon catheter of claim 23 where the metallic tubing comprises a superelastic alloy.

25. The balloon catheter of claim 2 where the second elongate member further comprises a radio-opaque marker band distal of said inflatable member.

26. The balloon catheter of claim 2 wherein said first elongate tubular member is tapered distal of said inflatable member and joined to said second elongate tubular member.

27. The balloon catheter of claim 2 wherein said second elongate tubular member further comprises a lubricious polymeric tubular inner-most tubing member.

28. The balloon catheter of claim 1 wherein said at least one fluid supply lumens is integral within said first member wall.

29. The balloon catheter of claim 28 wherein said at least one fluid supply lumens comprise passageways integral in and grooved in said first elongate tubular member and further comprising a lubricious inner member tubing closing said grooved passageways radially.

30. The balloon catheter of claim 1 wherein said catheter is of a flexibility, length, and diameter appropriate for a neurovascular microcatheter.

31. The balloon catheter of claim 1 wherein said catheter is of a flexibility, length, and diameter appropriate for a guide catheter.

32. The balloon catheter of claim 1 wherein said first elongate tubular member comprises a polymeric tubing.

33. The balloon catheter of claim 1 wherein said first elongate tubular member comprises a composite wall containing a helically wound coil.

34. The balloon catheter of claim 33 wherein said helically wound coil is wound from wire.

35. The balloon catheter of claim 33 wherein said helically wound coil is wound from ribbon.

36. The balloon catheter of claim 1 wherein said first elongate tubular member comprises a composite wall containing a braid.

37. A kit comprising:

a.) the balloon catheter of claim 1,

b.) a dilator having a dilator lumen extending from a proximal end of the dilator to a distal end of the dilator, said dilator having a diameter closely fitting said balloon catheter lumen,

c.) a microcatheter having a microcatheter lumen,

d.) a guidewire slideable within a member selected from the group consisting of the dilator lumen and the microcatheter lumen, and

e.) a clot retrieval device adapted to fit within the lumen of the balloon catheter with a retrieved clot.

38. The kit of claim 37 wherein the microcatheter is a balloon catheter.

39. The kit of claim 37 wherein the guidewire is adapted to slide within the dilator lumen.

40. The kit of claim 37 wherein the guidewire is adapted to slide within the microcatheter lumen.

41. A microballoon catheter kit comprising:

a.) the balloon catheter of claim 1 of a flexibility, length, and diameter appropriate for a neurovascular microcatheter and having a microcatheter lumen,

b.) a guidewire slideable within the microcatheter lumen, and

c.) a clot retrieval device adapted to fit within the lumen of the balloon catheter and extend to a radially expanded state.

42. A method for removing an embolus from a vascular lumen, comprising the steps of:

(a) introducing the balloon catheter of claim 1 to a position proximal said embolus,

(b) extending a microcatheter from the distal end of said balloon catheter to penetrate the embolus,

(c) extending a clot removal device through the embolus past the microcatheter,

(d) inflating the balloon of said balloon catheter to temporarily occlude the vascular lumen,

(e) withdrawing the microcatheter into the balloon catheter,

(f) withdrawing the clot removal device and the embolus into the balloon catheter,

(g) deflating the balloon of said balloon catheter, and

(h) withdrawing the balloon catheter and embolus.

43. The method of claim 42 wherein the steps of withdrawing the microcatheter and withdrawing the clot removal device and the embolus into the balloon catheter are simultaneous.

44. The method of claim 42 wherein the microcatheter is a balloon microcatheter.

45. The method of claim 42 wherein the vascular lumen is the middle cerebral artery.

46. The method of claim 42 wherein the vascular lumen is in a human periphery or coronary.

47. A method for treating a site in a vascular lumen, comprising the steps of:

(a) introducing the balloon catheter of claim 1 to a position in said lumen,

(b) inflating the balloon of said balloon catheter to temporarily occlude the vascular lumen,

(c) treating said site in the lumen,

(d) deflating the balloon of said balloon catheter, and

(e) withdrawing the balloon catheter.

48. The method of claim 47 wherein the microcatheter is a balloon microcatheter.

49. A method for performing a diagnostic step in a vascular lumen, comprising the steps of:

(a) introducing the balloon catheter of claim 1 to a position in said lumen,

(b) inflating the balloon of said balloon catheter to temporarily occlude the vascular lumen,

(c) performing a diagnostic step at said site in the lumen,

(d) deflating the balloon of said balloon catheter, and

(e) withdrawing the balloon catheter.

50. The method of claim 48 wherein the microcatheter is a balloon microcatheter.

51. A microballoon catheter comprising:

a first elongate polymeric tubular member having an outer surface, a proximal end, a distal end, a working lumen extending between said distal and proximal ends and being open at said distal end, and a radially recessed region near the distal end, and

a longitudinally-stretched inflatable member situated within said radially recessed region providing a substantially constant diameter in a region adjacent and across the radially recessed region and being fluid-connectable with at least one fluid supply lumen independent of said working lumen wherein said catheter is of a flexibility, length, and diameter appropriate for a neurovascular microcatheter.

52. The microballoon catheter of claim 51, further comprising a second elongate polymeric tubular member substantially concentric with the first elongate tubular member and having a lumen forming the working lumen and an outer surface forming an annular space between the first elongate tubular member, said annular space being the fluid supply lumen.

53. The microballoon catheter of claim 52, wherein said second elongate tubular member comprises a wall, a distal end, and a proximal end, and further comprising a stainless steel braided stiffener member situated to provide kink resistance to the microballoon catheter.

54. The microballoon catheter of claim 53, wherein said first elongate tubular member is tapered distal of said inflatable member and joined to said second elongate tubular member.

55. The microballoon catheter of claim 54, wherein the first elongate tubular member comprises a polyether-polyamide block copolymer.

56. The microballoon catheter of claim 55, wherein said second elongate tubular member comprises a lubricious polymeric tubular inner-most tubing member.

57. The microballoon catheter of claim 56, wherein said lubricious polymeric tubular inner-most tubing member comprises polytetrafluoroethylene having a wall thickness of 0.25 to 1.5 mils.

58. The microballoon catheter of claim 57, wherein said second elongate tubular member further comprises a polyether-polyamide block copolymer outer-most tubing member.

59. The microballoon catheter of claim 58, wherein the second elongate member further comprises a radio-opaque marker band distal of said inflatable member.

60. The microballoon catheter of claim 59, wherein said substantially constant diameter is between one French (0.33 mm) and several millimeters.

61. A balloon catheter having a substantially constant diameter comprising:

a first elongate tubular member having an outer surface, a proximal end, a distal end, a working lumen extending between said distal and proximal ends and being open at said distal end, and a radially recessed region near the distal end, and

an inflatable member situated within said radially recessed region providing said substantially constant diameter and being fluid-connectable with at least one fluid supply lumen independent of said working lumen.

62. The balloon catheter of claim 61, further comprising a second elongate tubular member substantially concentric with the first elongate tubular member and having a lumen forming the working lumen and an outer surface forming an annular space between the first elongate tubular member, said annular space being the fluid supply lumen.

63. The balloon catheter of claim 62, wherein said second elongate tubular member comprises a wall, a distal end, and a proximal end, and further comprising a stiffener member situated to provide kink resistance to the balloon catheter.

64. The balloon catheter of claim 63, wherein the stiffener member comprises a braid.

65. The balloon catheter of claim 61, wherein the inflatable member is compliant.

66. The balloon catheter of claim 61, wherein said catheter is of a flexibility, length, and diameter appropriate for a neurovascular microcatheter.

67. The balloon catheter of claim 62, wherein the second elongate member further comprises a radio-opaque marker band distal of said inflatable member.

68. The balloon catheter of claim 62, wherein said first elongate tubular member is tapered distal of said inflatable member and joined to said second elongate tubular member.

69. The balloon catheter of claim 62, wherein said second elongate tubular member further comprises a lubricious polymeric tubular inner-most tubing member.

70. The balloon catheter of claim 61, wherein said first elongate tubular member comprises a polymeric tubing.

71. The balloon catheter of claim 61, wherein the inflatable member is longitudinally stretched upon attachment to the first elongate tubular member.

72. The balloon catheter of claim 71, wherein the inflatable member is stretched longitudinally at least 10% upon attachment to the first elongate tubular member.

73. The balloon catheter of claim 72, wherein the inflatable member is stretched longitudinally about 15% upon attachment to the first elongate tubular member.