Flow apparatus for the disruption of occlusions

• US 6,139,543 A
• Filed: 07/22/1998
• Issued: 10/31/2000
• Est. Priority Date: 07/22/1998
• Status: Expired due to Fees

• Current Assignee: Selva Medical, Inc. (W.L. Gore and Associates), W. L. Gore & Associates (W.L. Gore & Associates)
• Original Assignee: Endovasix, Inc. (W.L. Gore and Associates)
• Inventors: Anderson, R. Rox, Esch, Victor C., Tran, Quang Q., Levine, Marc-Alan, Hebert, Stephen J., Sucgang, Eduardo U.
• Primary Examiner(s): Dvorak, Linda C. M.
• Assistant Examiner(s): GIBSON, ROY DEAN
• Application Number:
  US09/120,598
• Time in Patent Office: 832 Days
• Field of Search: 606/2, 606/7, 606/8, 606/15
• US Class Current: 606/7
• CPC Class Codes: A61B 18/245 for removing obstructions in blood vessels or calculi
• CPC Class Codes: A61B 18/26 for producing a shock wave, e.g. laser lithotripsy
• CPC Class Codes: A61B 2017/00176 Two pulses, e.g. second pulse having an effect different from the first one
• CPC Class Codes: A61B 2018/2211 Plurality of fibres

Abstract

The invention encompasses methods and apparatus for pumping fluid from one location to another through the repetitive expansion and collapse of bubbles generated as a result of the absorption of repetitive pulses of radiation in a fluid. This pumping phenomenon can be used to aid removal of a total or partial occlusion in a body passage by emulsifying the occlusion with acoustic shock and pressure waves or by mechanically disrupting the occlusive material.

Claims

1. An apparatus for pumping fluid in a body vessel, comprising:

at least one optical fiber having a proximal end of a construction sufficient for coupling with a source of radiation and a distal end of a construction sufficient for delivering radiation therefrom, and

a flow channel having an inlet port, said optical fiber distal end positioned within said flow channel relative to said inlet port such that radiation energy delivered to said fluid via said optical fiber causes a portion of said fluid to move through said inlet port into said flow channel.

2. The apparatus of claim 1, wherein said radiation energy comprises a plurality of pulses of radiation energy.

3. The apparatus of claim 2, wherein said fluid is caused to flow as a result of the expansion and collapse of a plurality of bubbles formed by the fluid absorbing said plurality of pulses of radiation energy.

4. The apparatus of claim 1, further comprising at least a second optical fiber and a second inlet port, said second fiber mounted relative to said second inlet port such that at least a portion of said flow passing through said first inlet port is directed through said second inlet port.

58. The apparatus of claims 1 or 5, further comprising a temperature-sensing device that produces a signal indicative of the temperature of said vessel contents in the vicinity of the distalmost portion of the apparatus.

59. The apparatus of claim 58, wherein said temperature-sensing device comprises a thermocouple having a distal end positioned in the vicinity of the distalmost portion of the apparatus.

60. The apparatus of claim 58, further comprising a controller for controlling the delivery of said pulses of radiation based on said temperature signal.

5. An apparatus for disrupting occlusive material that at least partially blocks a body vessel to the flow of fluid therein, comprising:

at least a first optical fiber having a proximal end of a construction sufficient for coupling with a source of radiation and a distal end of a construction sufficient for delivering radiation therefrom, said distal end positioned in said vessel in the vicinity of said occlusive material; and

a sheath having an inlet port, said distal end of said fiber positioned within said sheath relative to said inlet port such that introducing pulses of radiation energy into said vessel via said fiber causes fluid and/or occlusive material to move through the inlet port into the sheath, said apparatus causing at least a portion of the occlusive material to be disrupted.

6. The apparatus of claim 5, wherein radiation energy delivered through said first optical fiber generates the flow through the inlet port and causes said disruption.

7. The apparatus of claim 5, wherein said sheath comprises an inner tubular portion, said first optical fiber distal end mounted on said inner tubular portion such that said fluid tends to flow through the inlet port and through said inner tubular portion.

8. The apparatus of claim 5, wherein said occlusive material comprises a thrombus, embolus, or other blood clot.

9. The apparatus of claim 5 or 8, wherein said vessel is a cerebrovascular or carotid blood vessel.

10. The apparatus of claim 5, wherein said apparatus comprises a plurality of optical fibers.

11. The apparatus of claim 10, wherein radiation energy delivered through more than one of said fibers contributes to the flow created through the inlet port of said sheath.

12. The apparatus of claim 10, wherein radiation energy delivered through one or more of said fibers contributes to disrupting the occlusive material without contributing substantially to the flow created through the inlet port.

13. The apparatus of claim 10, wherein radiation energy delivered through one or more of said fibers contributes both to the flow created through the inlet port and to the disruption of the occlusive material.

14. The apparatus of claim 10, further comprising multiple sheaths, said sheaths arranged substantially concentrically to form one or more substantially annular regions, each said annular region having the distal tip of at least one optical fiber associated therewith.

15. The apparatus of claim 14, wherein said apparatus comprises three substantially concentric sheaths, said sheaths forming inner and outer substantially annular regions, said outer annular region having more optical fibers associated therewith than said inner annular region.

16. The apparatus of claim 15, wherein at least one optical fiber is positioned within said inner annular region, and at least three optical fibers are positioned within said outer annular region.

17. The apparatus of claim 16, wherein at least three of said plurality of optical fiber distal tips are substantially flush with the distal most portion of said apparatus.

18. The apparatus of claim 10, further comprising multiple sheaths mounted side by side, such that the external surface of each sheath is in contact with the external surface of at least one other sheath, each of said sheaths having the distal tip of at least one of said optical fibers associated therewith.

19. The apparatus of claim 18, wherein said distal tips of said optical fibers are mounted within said sheaths.

20. The apparatus of claim 10, further comprising a plurality of inlet ports located in the sidewall of said sheath, wherein each of said inlet ports corresponds to at least one of said plurality of fibers, wherein said distalmost portion of said apparatus comprises an outlet port towards which said flow is directed.

21. The apparatus of claim 10, further comprising a plurality of outlet ports, such that flow is generated through at least one outlet port as a result of said pulses of radiation energy being delivered via said plurality of optical fibers to said vessel.

22. The apparatus of claim 20 or 21, wherein said apparatus gyrates when said pulses of radiation are distributed between said plurality of optical fibers in a selected sequence.

23. The apparatus of claim 22, wherein said apparatus gyrates across the proximal surface of said occlusive material, thereby furthering disruption of said occlusive material.

24. The apparatus of claim 10, wherein one or more of the distal tips of said plurality of optical fibers are longitudinally offset from one another within said sheath.

25. The apparatus of claim 24, wherein said distal tips of said one or more longitudinally-offset fibers are positioned to further disrupt said occlusive material as said flow carries portions of disrupted occlusive material through said sheath.

26. The apparatus of claim 10, wherein the pulses of radiation are substantially evenly distributed between a first set of fibers comprising the fibers that disrupt the occlusive material without contributing substantially to flow through the inlet port, and a second set of fibers comprising the fibers that contribute to flow through the inlet port, such that each set of fibers receives about as much energy as the other set of fibers.

27. The apparatus of claim 26, wherein the energy received by each of said sets of fibers equals roughly one-half of the total energy delivered to the vessel containing the occlusive material.

28. The apparatus of claim 10, wherein the pulses of radiation are distributed substantially equally between each of said plurality of optical fibers designated to receive radiation energy.

29. The apparatus of claim 10, such that said radiation pulses are distributed among the multiple optical fibers in such a manner as to minimize the increase in temperature of the vessel contents adjacent the distal end of the apparatus.

30. The apparatus of claim 10 or 15 or 26, wherein the distal tip of at least one of said plurality of optical fibers is substantially flush with the distalmost portion of said apparatus.

31. The apparatus of claim 30, wherein the distalmost portion of said apparatus comprises said inlet port.

32. The apparatus of claim 10, wherein the distal tip of at least one of said plurality of fibers is radially located closer to the central axis of said sheath than others of said fiber distal tips.

33. The apparatus of claim 32, wherein the distal tip of at least one of said plurality of fibers is most centrally radially located, and the distal tips of at least three of said fibers are less centrally radially located.

34. The apparatus of claim 33, wherein the distal tips of at least three others of said fibers are even less centrally radially located.

35. The apparatus of claim 10, wherein said inlet port comprises a hole in the sidewall of said sheath.

36. The apparatus of claim 35, wherein an outlet port is distal from said inlet port, wherein said plurality of optical fiber distal tips are positioned adjacent said inlet port such that firing radiation pulses along said plurality of optical fibers causes material to enter said inlet port and be ejected through said outlet port.

37. The apparatus of claim 36, wherein said distal ends of said optical fibers are aligned across the width of said inlet port.

38. The apparatus of claim 36 or 37, wherein the distalmost portion of said sheath comprises said outlet port.

39. The apparatus of claim 5, wherein the distalmost portion of said sheath comprises said inlet port.

40. The apparatus of claim 39, wherein said distal end of said optical fiber is positioned within about 350 microns of said inlet port.

41. The apparatus of claim 39, wherein said distal end of said optical fiber is positioned within a range of from about 100 microns to about 350 microns of said inlet port.

42. The apparatus of claim 39, wherein the distal portion of said sheath is necked, such that the largest dimension of said inlet port is not greater than the diameter of the remainder of said sheath.

43. The apparatus of claim 5, wherein said sheath further comprises an outlet port.

44. The apparatus of claim 43, wherein said inlet port is distal of said outlet port.

45. The apparatus of claim 43, wherein said inlet port is proximal of said outlet port.

46. The apparatus of claim 45, wherein said distalmost portion of said sheath comprises said outlet port.

47. The apparatus of claim 43, wherein said inlet and said outlet ports are both proximal from said distalmost portion of said sheath.

48. The apparatus of claim 43, wherein at least one of said inlet and outlet ports is of variable cross-sectional area.

49. The apparatus of claim 48, wherein said sheath comprises a spring, wherein said variable cross-sectional area port comprises a plurality of gaps between adjacent windings of said spring.

50. The apparatus of claim 43, wherein said sheath comprises a spring, wherein said spring has a distal opening, a tightly-wound distal portion, and a less-tightly-wound proximal portion, said proximal portion serving as one of said inlet and said outlet ports, wherein said distal opening comprising the distalmost portion of said distal portion serves as the other of said inlet and outlet ports.

51. The apparatus of claim 43, wherein said outlet port comprises a slot in the sidewall of said sheath.

52. The apparatus of claim 43, wherein said outlet port comprises multiple openings in the sidewall of said sheath.

53. The apparatus of claim 43, wherein the distalmost portion of said outlet port is more than about 5 mm proximal from the distalmost portion of said apparatus.

54. The apparatus of claim 5 or 6, wherein said disruption comprises emulsification of said occlusive material via acoustic phenomena resulting from the absorption of said radiation pulses.

55. The apparatus of claim 5 or 49, further comprising a catheter, said sheath comprising the distal portion of said catheter.

56. The apparatus of claim 55, wherein said catheter comprises a plurality of sections, each section having a flexibility, the flexibility of each of said sections increasing from proximal to distal, such that the distalmost section of the catheter has the greatest flexibility.

57. The apparatus of claim 5, further comprising a spring having multiple coils, said spring connected to said sheath, wherein the gaps between adjacent coils of a portion of said spring proximal from the distalmost portion of said sheath comprise one of said inlet port or an outlet port.

61. The apparatus of claim 5, further comprising a lumen for delivering fluid to the site of the occlusive material.

62. The apparatus of claim 61, wherein said delivered fluid comprises one or more of the group consisting of a thrombolytic agent, a biocompatible coolant, a radiographic agent for facilitating visualization, and a dye to promote absorption of the pulses of radiation.

63. The apparatus of claim 5, further comprising a lumen for aspirating material from said vessel to a second location remote from the location of said occlusive material.

64. The apparatus of claim 63, wherein said second location is external to the body being treated.

65. The apparatus of claim 5, wherein said pulsed radiation energy comprises one or more parameters selected from the group of pulse duration, pulse repetition rate, duty cycle and energy per pulse, said one or more parameters selected to disrupt said occlusive material without thermally damaging the surrounding tissue.

66. The apparatus of claim 5, wherein said fluid and/or material flowing through the inlet port comprises blood.

67. The apparatus of claim 5, wherein radiation energy delivered through said first optical fiber generates said flow, and radiation energy delivered through at least a second optical fiber causes said disruption.

68. The apparatus of claim 67, wherein said first optical fiber is positioned more radially central in said sheath than said second optical fiber.

69. The apparatus of claim 67, wherein a distal end of said second optical fiber is positioned substantially flush with a distal opening of said sheath.

70. An apparatus for pumping a fluid that is in fluid communication therewith, comprising:

a channel of a construction sufficient for a flow of the fluid through at least a distal portion thereof;

means within said channel for delivering radiation energy to the fluid sufficient to cause a net displacement of at least a portion of the fluid from an initial location in a vicinity of the distal portion through the distal portion and into said channel.

71. The apparatus according to claim 70, wherein the means for delivering radiation energy comprises means for delivering radiation energy sufficient to produce at least one bubble in the fluid.

72. The apparatus according to claim 71, wherein the radiation energy is absorbed by the fluid to produce the at least one bubble.

73. The apparatus according to claim 71, wherein the at least one bubble is transitory.

74. The apparatus according to claim 71, wherein the at least one bubble expands and collapses such that the fluid moves from the initial location through the distal portion.

75. The apparatus according to claim 70, wherein the radiation energy comprises pulsed radiation energy.

76. The apparatus according to claim 70, wherein the means for delivering radiation energy is an optical fiber.

77. The apparatus according to claim 70, wherein the fluid is blood.

78. The apparatus according to claim 70, wherein the fluid has an occlusive material therein.

79. The apparatus according to claim 70, wherein a source of the fluid is a body vessel.

80. The apparatus according to claim 79, wherein said channel is of a construction sufficient for delivery into the body vessel.

81. An apparatus according to claim 70, further comprising a source of radiation energy.

82. An apparatus according to claim 81, wherein the source of radiation energy is a laser.

83. A catheter having a proximal end, a distal end, an elongated member therebetween, and an optical fiber distal tip disposed within said catheter, said catheter further having at least two openings distal from said proximal end and in fluid communication with one another, the first of said openings for permitting fluid from a vessel to enter said catheter and the second of said openings for permitting said fluid to exit said catheter, said first opening in the vicinity of the optical fiber distal tip.