Ultrasound transmission apparatus and method of using same

• US 5,971,949 A
• Filed: 05/19/1997
• Issued: 10/26/1999
• Est. Priority Date: 08/19/1996
• Status: Expired due to Fees

• Current Assignee: Angiosonics, Inc. (Acolysis Intravascular Ultrasound Business) (Teleflex Incorporated)
• Original Assignee: Angiosonics, Inc. (Acolysis Intravascular Ultrasound Business) (Teleflex Incorporated)
• Inventors: Nguyen, Loi, Rosenschein, Uri, Levin, Philip S., Saltonstall, Jon
• Primary Examiner(s): Jaworski, Francis J.
• Application Number:
  US08/858,247
• Time in Patent Office: 890 Days
• Field of Search: 604/22, 604/27, 604/28, 604/44, 604/52, 606/159, 606/169, 601/2
• US Class Current: 604/22
• CPC Class Codes: A61B 17/22012 in direct contact with, or very close to, the obstruction or concrement for removing obstructions in blood vessels by laser A61B18/245
• CPC Class Codes: A61B 17/320068 using mechanical vibrations, e.g. ultrasonic A61B17/22012 takes precedence; dental tooth drilling devices operated by vibration A61C3/03; removing intra-ocular material using mechanical vibrations A61F9/00745
• CPC Class Codes: A61B 2017/22002 preventing restenosis
• CPC Class Codes: A61B 2017/320069 for ablating tissue
• CPC Class Codes: A61B 2017/320073 probe
• CPC Class Codes: A61B 2017/320089 node location
• CPC Class Codes: A61B 2018/00011 with fluids
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: G10K 11/24 for conducting sound through solid bodies, e.g. wires

Abstract

An ultrasonic treatment system and method for utilizing ultrasound to treat intravascular conditions, such as stenotic and occluded regions of blood vessels, are provided. The ultrasonic treatment system includes an ultrasonic probe, having a proximal and distal end. A guide catheter and guidewire may also be provided and the probe can be slidably disposed within the guide catheter'"'"'s inner lumen. The probe can include a horn at the proximal end, a transmission member with a proximal and a distal end connected to the horn at the transmission member proximal end, and a distal tip connected at the transmission member'"'"'s distal end. The transmission member may include one or more transmission wires, having proximal and distal ends, connected serially or in parallel.

Claims

1. An ultrasound transmission device constructed to be coupled to an ultrasound energy source emitting ultrasound energy at a frequency f, the device dimensioned and constructed for insertion within a blood vessel for use in applying the ultrasound energy within a blood vessel or a cavity, and for generating a standing wave having displacement maxima and displacement minima at locations along the ultrasound transmission device, comprising:

a first transmission member connectable to the ultrasound energy source, the first transmission member formed as a unitary body of a first material and having a proximal end and a distal end, the distal end of the first transmission member terminating approximately at a displacement minimum;

a second transmission member formed of a second material, which may be the same as the first material, having a proximal and distal end, the proximal end of the second transmission member coupled to the distal end of the first transmission member, wherein the cross-sectional area of the distal end of the first transmission member is greater than the cross-sectional area of the proximal end of the second transmission member, and the distal end of the second transmission member terminates approximately at a displacement maximum; and

a tip connected to the distal end of the second transmission member, the first transmission member, the second transmission member and the tip constructed such that when the proximal end of the first transmission member is attached to the ultrasonic energy source and the ultrasonic energy source is activated within a blood vessel, a standing wave is generated in the first transmission member, second transmission member and tip, the tip being constructed and dimensioned to apply ultrasound energy when the ultrasound energy source applied to the first transmission member and transmitted to the tip via the first transmission member and the second transmission member.

2. The ultrasound transmission device of claim 1, wherein the first and second transmission members are each fabricated from a single, continuous material.

3. The ultrasound transmission device of claim 1, wherein the tip is constructed and dimensioned to cause cavitation of ablate, lyse or otherwise remove or loosen obstructing material within said blood vessel.

4. The ultrasound transmission device of claim 1, wherein the tip and the second transmission member are fabricated from a single, continuous material.

5. The ultrasound transmission device of claim 1, wherein the tip is machined from a welded or brazed section formed at the distal end of the second transmission member.

6. The ultrasound transmission device of claim 1, wherein the second transmission member is coupled to the first transmission member by means of a releasable connector.

7. The ultrasound transmission device of claim 1, wherein the first transmission member is fabricated from aluminum and the second transmission member is fabricated from titanium.

8. The ultrasound transmission device of claim 1, wherein the first transmission member is fabricated from aluminum 7075.

9. The ultrasound transmission device of claim 1, wherein the second transmission member is fabricated from Ti/4A1/6V.

10. The ultrasound transmission device of claim 1, wherein the second transmission member is connected to the first transmission member by a mechanical attachment.

11. The ultrasound transmission device of claim 1, wherein the second transmission member is connected to the first transmission member by at least one of welding, swaging, crimping, clamping, pinning, and adhesive bonding.

12. The ultrasound transmission device of claim 1, wherein the first transmission member has a first section and a second section and wherein the first section and the second section each has a proximal and distal end;

the first section has a taper of diminishing cross-sectional area from the proximal end of the first section to the distal end of the first section;

the second section has a constant cross-sectional area; and

the distal end of the second section terminates approximately at a displacement minimum during operation.

13. The ultrasound transmission device of claim 12, wherein the first section of the first transmission member has a length substantially equal to a multiple of λ

/2, and where λ

is the wavelength of the standing wave in that section.

14. The ultrasound transmission device of claim 12, wherein the length of the first section and the second section of the first transmission members together is substantially equal to an odd multiple of λ

/4, and where λ

is the wavelength of the standing wave in that section.

15. The ultrasound application apparatus of claim 12, wherein the first section has a length approximately equal to 144 mm.

16. The ultrasound transmission device of claim 1, wherein the second transmission member includes at least two sections, and the more proximal of the consecutive at least two sections has a greater cross-sectional area than the more distal of the at least two sections.

17. The ultrasound transmission device of claim 16, wherein at least one connection between sections of the at least two sections of the second transmission member is at a displacement minimum.

18. The ultrasound transmission device of claim 16, wherein the most distal of the at least two sections of the second transmission member includes at least two parallel transmission wires.

19. The ultrasound transmission device of claim 18, including sheathing, wherein the sheathing includes a single-lumen-to-multi-lumen joint so as to promote the passage of a fluid around the first and second sections of the second transmission member.

20. The ultrasound transmission device of claim 19, including a first guidewire tube for tracking a guidewire, the first guidewire tube running substantially parallel to, and having substantially the same length as, the at least two transmission wires.

21. The ultrasound transmission device of claim 20, wherein the first guidewire tube is coupled to the sheathing of the at least two transmission wires.

22. The ultrasound transmission device of claim 20, wherein the first guidewire tube terminates proximal the tip.

23. The ultrasound transmission device of claim 22, wherein the tip includes a through-hole through which a second guidewire tube assembly passes, the second guidewire tube assembly being slidably disposed relative to the first guidewire tube.

24. The ultrasound transmission device of claim 18, including sheathing, wherein the sheathing is attached to the first transmission member at a displacement minimum.

25. The ultrasound transmission device of claim 24, wherein the sheathing is attached to the first transmission member by means of an O-ring seal assembly.

26. The ultrasound transmission device of claim 25, wherein the O-ring seal assembly includes a keyed or shaped element that prevents independent rotation of the sheathing relative to the first and second transmission members.

27. The ultrasound transmission device of claim 18, wherein each of the at least two transmission wires, when viewed in cross-section, are spaced equally on a circle concentric with the longitudinal axis of the ultrasound transmission device.

28. The ultrasound transmission device of claim 18, wherein the tip includes a through-hole for the passage of a guidewire, said through-hole centrally located on the longitudinal axis of the tip.

29. The ultrasound application apparatus of claim 18, wherein the first section of the second transmission member has a diameter of approximately 0.62 mm.

30. The ultrasound application apparatus of claim 18, wherein the at least two transmission wires have diameters of approximately 0.29 mm.

31. The ultrasound application apparatus of claim 18, wherein the at least two transmission wires have lengths of approximately 160 mm.

32. The ultrasound transmission device of claim 1, wherein the second transmission member has a substantially constant diameter.

33. The ultrasound transmission device of claim 1, wherein the first and second transmission members are at least partially coated with a stress-corrosion barrier.

34. The ultrasound transmission device of claim 33, wherein the stress-corrosion barrier is parylene.

35. The ultrasound transmission device of claim 1, including sheathing, and the first transmission member and the second transmission member are at least partially covered with the sheathing.

36. The ultrasound transmission device of claim 35, wherein the sheathing includes polyimide tubing.

37. The ultrasound application apparatus of claim 35 wherein the sheathing of the second transmission member terminates prior to the tip.

38. The ultrasound transmission device of claim 1, wherein the distal end of the first transmission member includes a region of slightly greater cross-sectional area than the region immediately proximal the increased-cross-sectional-area region and the increased-cross-sectional-area region is bored to accept the proximal end of the second transmission member.

39. The ultrasound transmission device of claim 1, wherein the first transmission member and the second transmission member are at least partially coated with parylene and at least partially contained in sheathing.

40. The ultrasound transmission device of claim 1, wherein the device is sized and configured to be used in conjunction with a 7 French guide catheter.

41. The ultrasound transmission device of claim 1, wherein the tip includes a through-hole for the passage of a guidewire.

42. The ultrasound application apparatus of claim 1, wherein the length of the first and the second transmission members together is substantially equal to an odd multiple of λ

/4, and where λ

is the wavelength of the standing wave in that section during use.

43. The ultrasound application apparatus of claim 1, wherein the distal end of the first transmission member has a diameter of approximately 1 mm.

44. The ultrasound application apparatus of claim 1, wherein the first transmission member has a length of approximately 711 mm.

45. The ultrasound application apparatus of claim 1, wherein the device is sized and configured to extend from an opening into the body, through a portion of the vasculature having a proximal section and a distal, more tortuous section, to an internal location within the body, and the first transmission member is sized such that the distal end of the first transmission member terminates approximately proximal the tortuous section of the portion of the vasculature.

46. The ultrasound application apparatus of claim 45, wherein the proximal section of the vasculature is a portion of the femoral, iliac, and descending aorta artery and the tortuous portion of the vasculature is the aortic arch, ascending aorta and a coronary artery.

47. The ultrasound application apparatus of claim 1 wherein the tip includes a radiopaque material.

48. The ultrasound application apparatus of claim 1 wherein the probe is actuated by a transducer and supports a standing wave.

49. An ultrasound application apparatus for transmitting ultrasound to a location within a human body, comprising:

an ultrasound transmission device having a first, second and third member;

an ultrasound generating device constructed and arranged with the transmission device to generate a standing wave having displacement maxima and minima along the length of the transmission device;

the first member of the transmission device extending distally from the proximal end of the ultrasonic generating device, the first member having a cross-sectional dimension selected from the group consisting of a substantially exponential, catenary, straight, quadratic, or hyperbolic taper, or a uniform cross-sectional dimension, or combinations thereof, and the distal end of the first member terminating approximately at a displacement minimum;

the second member of the transmission device extending distally from the distal end of the first member and formed of a second material, which may be the same as the first member material, coupled to the distal end of the first member, the second member having a substantially uniform cross-sectional dimension smaller than the cross-sectional dimension of the distal portion of the first member; and

the third member of the transmission device extending distally from the distal end of the second member, formed of a third material which may be the same as the second material, coupled to the distal end of the second member, the third member including one or more transmission wires, each transmission wire having a substantially uniform cross-sectional dimension which is smaller than the cross-sectional dimension of the second member, and the distal end of the third member terminating approximately at a displacement maximum.

50. The ultrasound application apparatus of claim 49, including a tip connected to the distal end of the third member, the tip constructed and dimensioned to apply ultrasonic energy when the device is driven by an ultrasonic energy source connected to the proximal end of the first member and transmitted to the tip via the first, second and third members.

51. The ultrasound application apparatus of claim 50, wherein the tip is constructed and dimensioned to cause cavitation of lyse, ablate or otherwise removal or loosening of obstructing material within a blood vessel or cavity when activated.

52. The ultrasound application apparatus of claim 50, wherein the tip and the second member are fabricated from a single, continuous material.

53. The ultrasound application apparatus of claim 52, including a first guidewire tube for tracking a guidewire, the first guidewire tube substantially the same length as, and running parallel to, the at least two transmission wires.

54. The ultrasound application apparatus of claim 53, wherein the third member includes three transmission wires.

55. The ultrasound application apparatus of claim 50, wherein the tip is machined from a welded or brazed section at the distal end of the third member.

56. The ultrasound transmission device of claim 50, wherein the first member is formed of aluminum.

57. The ultrasound application apparatus of claim 50, wherein the first member has a length equal to an odd multiple of λ

/4 based on the standing wave of the device.

58. The ultrasound application apparatus of claim 50, wherein the first member includes a section having a substantially exponentially tapered cross-sectional dimension.

59. The ultrasound application apparatus of claim 50, wherein the first member includes a section having a substantially catenary tapered cross-sectional dimension.

60. The ultrasound transmission device of claim 50, wherein the first member includes a section having a substantially hyperbolic tapered cross-sectional dimension.

61. The ultrasound application apparatus of claim 50, wherein the first member includes a section having a constant first cross-sectional dimension.

62. The ultrasound application apparatus of claim 50, wherein the second member includes at least two sections connected to each other along the longitudinal axis of the device, a more distal section having a substantially uniform cross-sectional dimension smaller than the cross-sectional dimension of the more proximal section.

63. The ultrasound application apparatus of claim 62, wherein at least one of the at least two sections of the second member are so dimensioned that its proximal end is at a displacement minimum.

64. The ultrasound application apparatus of claim 50, wherein the third member includes at least two substantially parallel transmission wires.

65. The ultrasound application apparatus of claim 64, wherein the diameter of each of the at least two transmission wires is between 0.5 mm and 0.01 mm.

66. The ultrasound application apparatus of claim 64, wherein the length of the at least two transmission wires is less than about 300 mm.

67. The ultrasound application apparatus of claim 50, including a first guidewire tube for tracking a guidewire, the first guidewire tube substantially the same length as, and running parallel to, at least two of the one or more transmission wires.

68. The ultrasound application apparatus of claim 67, wherein the first guidewire tube extends through a hole in the tip.

69. The ultrasound application apparatus of claim 67, wherein the third member includes three transmission wires.

70. The ultrasound application apparatus of claim 67, wherein the at least two transmission wires are partially contained in sheathing, and the first guidewire tube is coupled to the sheathing of the at least two transmission wires.

71. The ultrasound application apparatus of claim 50, wherein the first member includes a proximal section and a distal section, the distal section having a substantially uniform cross-sectional dimension smaller than the cross-sectional dimension of the proximal end of the proximal section.

72. The ultrasound application apparatus of claim 71, wherein the proximal section has a length approximately equal to a multiple of λ

/2, where λ

is the wavelength of the standing wave in the proximal section.

73. The ultrasound application apparatus of claim 50, wherein the first, second and third members are at least in part contained in sheathing.

74. The ultrasound application apparatus of claim 73, wherein the sheathing is formed at least partly of polyimide.

75. The ultrasound application apparatus of claim 50, wherein the device is sized to be used in conjunction with a 7 French guide catheter.

76. The ultrasound application apparatus of claim 50 wherein the tip includes a radiopaque material.

77. The ultrasound application apparatus of claim 50, wherein the first, second and third members are at least partially coated with a stress-corrosion barrier.

78. The ultrasound application apparatus of claim 49, wherein the length of the first member is between 50 mm and 1000 mm.

79. The ultrasound application apparatus of claim 49, wherein the first member has a length of approximately 317 mm.

80. The ultrasound application apparatus of claim 49, wherein the first member has a length of approximately 711 mm.

81. The ultrasound application apparatus of claim 49, wherein the diameter of the first member decreases from the proximal end to the distal end thereof, and is between 15 mm and 0.5 mm.

82. The ultrasound application apparatus of claim 49, wherein the diameter of the distal end of the first member is approximately 1.0 mm.

83. The ultrasound application apparatus of claim 49, wherein the length of the second member is less than about 1000 mm.

84. The ultrasound application apparatus of claim 49, wherein the diameter of the second member is between 1.0 mm and 0.2 mm.

85. The ultrasound application apparatus of claim 49, wherein the first member has a length of approximately 567 mm, and the second member has a length of approximately 156 mm.

86. The ultrasound application apparatus of claim 49, wherein the device is sized and configured to extend into an opening into the body, through a pathway which may include a portion of the vasculature, the pathway having a proximal section and a distal, more tortuous section, to an internal location within the body, and the first member is sized such that the distal end of the first member terminates within the first section of the pathway.

87. The ultrasound application apparatus of claim 86, wherein the proximal section of the pathway includes a guiding catheter or introducer sheath and the tortuous portion of the vasculature is within a blood vessel.