Apparatus and method for an ultrasonic probe capable of bending with aid of a balloon

• US 20050256410A1
• Filed: 05/14/2004
• Published: 11/17/2005
• Est. Priority Date: 05/14/2004
• Status: Abandoned Application

• Current Assignee: Cybersonics, Inc
• Original Assignee: OmniSonics Medical Technologies, Inc.
• Inventors: Rabiner, Robert A., Rabiner, Daniel E., Hare, Bradley A., Marciante, Rebecca I., Varady, Mark J.
• Application Number:
  US10/846,038
• Publication Number:
  US 20050256410A1
• Time in Patent Office: Days
• US Class Current: 600/470
• CPC Class Codes: A61B 17/2202 the ultrasound transducer being inside patient's body at the distal end of the catheter
• CPC Class Codes: A61B 2017/003 Steerable
• CPC Class Codes: A61B 2017/22052 eccentric
• CPC Class Codes: A61B 2017/22061 for spreading elements apart
• CPC Class Codes: A61B 2017/22071 Steering
• CPC Class Codes: A61B 2017/3445 used as instrument channel for multiple instruments catheters A61B2017/22072

Abstract

The present invention provides an apparatus and a method for an ultrasonic probe capable of bending, flexing and deflecting with the aid of a balloon to remove a biological material. An ultrasonic medical device includes a balloon catheter, a balloon that is supported by the balloon catheter, an inflation lumen located along a longitudinal axis of the balloon catheter and an ultrasonic probe located along an outside surface of the balloon catheter wherein the ultrasonic probe engages an outer surface of the balloon. The ultrasonic probe is inserted through at least one engaging mechanism on an outside surface of the balloon catheter. The inflated balloon causes the ultrasonic probe to bend, allowing the ultrasonic probe to move along a bend in a vasculature and increase a surface area of the ultrasonic probe in communication with the biological material for ablation.

Claims

1. An ultrasonic medical device comprising:

a balloon catheter having a proximal end, a distal end and a longitudinal axis therebetween;

an inflation lumen located along the longitudinal axis of the balloon catheter;

a balloon supported by the balloon catheter, an inner surface of the balloon in communication with the inflation lumen; and

an ultrasonic probe located along an outside surface of the balloon catheter, the ultrasonic probe engaging an outer surface of the balloon.

2. The device of claim 1 wherein the inflation lumen is located on the outside surface of the balloon catheter.

3. The device of claim 1 wherein the inflation lumen is located inside of the balloon catheter.

4. The device of claim 1 wherein the balloon catheter further comprises a proximal engaging mechanism located along the outside surface of the balloon catheter.

5. The device of claim 4 wherein the balloon catheter further comprises a distal engaging mechanism located along the outside surface of the balloon catheter.

6. The device of claim 1 wherein the balloon catheter further comprises a plurality of engaging mechanisms located along the outside surface of the balloon catheter.

7. The device of claim 1 wherein the ultrasonic probe extends through an at least one engaging mechanism located along the outside surface of the balloon catheter.

8. The device of claim 1 further comprising an at least one engaging mechanism located at the distal end of the balloon catheter.

9. The device of claim 1 wherein a portion of the balloon is located between a proximal engaging mechanism located along the outside surface of the balloon catheter and a distal engaging mechanism located along the outside surface of the balloon catheter.

10. The device of claim 1 further comprising a channel located along the outside surface of the longitudinal axis of the balloon catheter.

11. The device of claim 10 wherein the ultrasonic probe resides in the channel.

12. The device of claim 1 wherein the balloon is non-compliant.

13. The device of claim 1 further comprising a second ultrasonic probe located along the outside surface of the balloon catheter.

14. An ultrasonic medical device comprising:

a balloon catheter comprising an at least one engaging mechanism located along an outside surface of the balloon catheter;

a balloon having an outer surface and an inner surface, the balloon engaging the outside surface of the balloon catheter;

an elongated ultrasonic probe extending through the at least one engaging mechanism and engaging the outer surface of the balloon; and

an inflation lumen in communication with the balloon, the inflation lumen located along the longitudinal axis of the balloon catheter.

15. The device of claim 14 wherein the inflation lumen is located inside of the balloon catheter.

16. The device of claim 14 wherein the inflation lumen is located on the outside surface of the balloon catheter.

17. The device of claim 14 wherein one of the at least one engaging mechanisms is located at a distal end of the balloon catheter.

18. The device of claim 14 wherein the elongated ultrasonic probe engages the outer surface of the balloon when the balloon is inflated.

19. The device of claim 14 wherein the balloon is non-compliant.

20. The device of claim 14 wherein an injection of a medium through the inflation lumen expands the balloon to guide the elongated ultrasonic probe.

21. The device of claim 14 wherein a distal end of the elongated ultrasonic probe moves in response to changes in a shape of the balloon.

22. The device of claim 14 wherein the balloon is located over a portion of a circumference of the balloon catheter.

23. The device of claim 14 wherein a portion of the balloon is located adjacent to the at least one engaging mechanism.

24. A method of moving an ultrasonic probe along a bend in a vasculature to ablate an occlusion in the vasculature comprising:

inserting the ultrasonic probe through a proximal engaging mechanism located on an outside surface of a balloon catheter;

moving the ultrasonic probe over an outer surface of a balloon supported by the balloon catheter and through a distal engaging mechanism located on the outside surface of the balloon catheter;

advancing the balloon catheter until the balloon is adjacent to the bend in the vasculature;

inflating the balloon causing the outer surface of the balloon to engage the ultrasonic probe, thereby causing the ultrasonic probe to bend between the proximal engaging mechanism and the distal engaging mechanism;

advancing the ultrasonic probe along the outer surface of the balloon to move the ultrasonic probe along the bend in the vasculature adjacent to the occlusion; and

energizing the ultrasonic probe to ablate the occlusion at the bend in the vasculature.

25. The method of claim 24 further comprising inflating the balloon through an injection of a medium in an inflation lumen located along a longitudinal axis of the balloon catheter.

26. The method of claim 25 further comprising engaging the medium to an inner surface of the balloon through an at least one inflation opening along a longitudinal axis of the inflation lumen.

27. The method of claim 24 further comprising changing a shape of the balloon to move a distal end of the ultrasonic probe.

28. The method of claim 24 further comprising engaging a medium to an inner surface of the balloon to move a distal end of the ultrasonic probe.

29. The method of claim 24 further comprising modifying a length of the balloon along a longitudinal axis of the balloon catheter to move a distal end of the ultrasonic probe.

30. The method of claim 24 further comprising increasing a surface area of the ultrasonic probe in communication with the occlusion through an inflation of the balloon.

31. The method of claim 24 further comprising inflating the balloon to provide a large active area for ablation of the occlusion.

32. The method of claim 24 further comprising inflating the balloon to maximize a radial span of the ultrasonic probe within the vasculature.

33. The method of claim 24 further comprising inflating the balloon to expand a treatment area of the ultrasonic probe.

34. The method of claim 24 further comprising inflating the balloon to focus an occlusion destroying effect of the ultrasonic probe.

35. The method of claim 24 further comprising inflating the balloon to support the ultrasonic probe.

36. The method of claim 24 further comprising moving the ultrasonic probe back and forth along the occlusion.

37. The method of claim 24 further comprising sweeping the ultrasonic probe along the occlusion.

38. The method of claim 24 further comprising rotating the ultrasonic probe along the occlusion.

39. The method of claim 24 further comprising twisting the ultrasonic probe along the occlusion.

40. The method of claim 24 wherein the balloon is a non-compliant balloon.

41. A method of moving a flexible ultrasonic probe capable of having a non-linear shape along a bend within a vasculature of a body to remove a biological material comprising:

providing a balloon catheter having a balloon in communication with an outside surface of the balloon catheter and the flexible ultrasonic probe extending along an outer surface of the balloon;

inflating the balloon to increase a surface area of the flexible ultrasonic probe in communication with the biological material;

moving the flexible ultrasonic probe along the outer surface of the balloon to move the flexible ultrasonic probe along the bend in the vasculature toward the biological material; and

activating an ultrasonic energy source to provide an ultrasonic energy to the ultrasonic probe to remove the biological material.

42. The method of claim 41 further comprising inserting the flexible ultrasonic probe through an engaging mechanism located on the outside surface at a distal end of the balloon catheter.

43. The method of claim 41 further comprising inserting the flexible ultrasonic probe through a plurality of engaging mechanisms located on the outside surface of the balloon catheter.

44. The method of claim 41 further comprising injecting a medium in an inflation lumen to inflate the balloon.

45. The method of claim 44 further comprising engaging the medium to the inner surface of the balloon through an inflation opening along a longitudinal axis of the inflation lumen.

46. The method of claim 41 further comprising bending the flexible ultrasonic probe at an angle to a longitudinal axis of the balloon catheter.

47. The method of claim 41 further comprising changing a shape of the balloon to move a distal end of the flexible ultrasonic probe.

48. The method of claim 41 further comprising engaging a medium to an inner surface of the balloon to move a distal end of the flexible ultrasonic probe.

49. The method of claim 41 further comprising modifying a length of the balloon along a longitudinal axis of the balloon catheter to move a distal end of the flexible ultrasonic probe.

50. The method of claim 41 further comprising locating the balloon over a portion of a circumference of the balloon catheter.

51. The method of claim 41 further comprising inflating the balloon to increase a radial span of the flexible ultrasonic probe within the vasculature.

52. The method of claim 41 further comprising inflating the balloon to expand a treatment area of a biological material destroying effect of the flexible ultrasonic probe.

53. A balloon catheter comprising:

a proximal end, a distal end and a longitudinal axis therebetween;

an inflation lumen located along the longitudinal axis of the balloon catheter;

a balloon supported by the balloon catheter, an inner surface of the balloon in communication with the inflation lumen; and

a distal engaging mechanism extending from an outside surface of the distal end of the balloon catheter.

54. The balloon catheter of claim 53 wherein the distal engaging mechanism comprises an opening having chamfered edges surrounded by a support structure.

55. The balloon catheter of claim 54 wherein the chamfered edges of the opening of the distal engaging mechanism extend downward in the direction of the distal end of the balloon catheter.

56. The balloon catheter of claim 53 further comprising a proximal engaging mechanism extending from the outside surface of the balloon catheter proximal to the distal engaging mechanism.

57. The balloon catheter of claim 56 wherein the proximal engaging mechanism comprises an opening having chamfered edges surrounded by a support structure.

58. The balloon catheter of claim 57 wherein the chamfered edges of the opening of the proximal engaging mechanism extend upward in the direction of the distal end of the balloon catheter.

59. The balloon catheter of claim 53 wherein an opening in the distal engaging mechanism has a keyhole shape with a smaller upper section adjacent to a lower section.

60. The balloon catheter of claim 53 wherein an opening in the distal engaging mechanism has a keyhole shape with an upper section adjacent to a smaller lower section.

61. The balloon catheter of claim 56 wherein an opening in the proximal engaging mechanism has a keyhole shape with a smaller upper section adjacent to a lower section.

62. The balloon catheter of claim 56 wherein an opening in the proximal engaging mechanism has a keyhole shape with an upper section adjacent to a smaller lower section.

63. The balloon catheter of claim 53 wherein the inflation lumen is located on the outside surface of the balloon catheter.

64. The balloon catheter of claim 53 wherein the inflation lumen is located inside of the balloon catheter.

65. A balloon catheter comprising:

a proximal end, a distal end and a longitudinal axis therebetween;

an inflation lumen located along the longitudinal axis of the balloon catheter;

a balloon supported by the balloon catheter, an inner surface of the balloon in communication with the inflation lumen; and

a channel along an outside surface of the balloon catheter.

66. The balloon catheter of claim 65 further comprising a lumen extending from the channel to the proximal end of the balloon catheter.

67. The balloon catheter of claim 65 further comprising a distal channel engaging support located along the distal end of the balloon catheter.

68. The balloon catheter of claim 65 further comprising a proximal channel engaging support located proximal to the distal end of the balloon catheter.

69. The balloon catheter of claim 65 further comprising a distal channel engaging support at the distal end of the balloon catheter and a proximal channel engaging support located proximal to the distal channel engaging support.

70. The balloon catheter of claim 65 wherein the inflation lumen is located on the outside surface of the balloon catheter.

71. The balloon catheter of claim 65 wherein the inflation lumen is located inside of the balloon catheter.

72. The balloon catheter of claim 65 wherein the balloon is non-compliant.

73. The balloon catheter of claim 65 wherein an injection of a medium through the inflation lumen expands the balloon.

74. The balloon catheter of claim 65 wherein the balloon is located over a portion of a circumference of the balloon catheter.

75. An ultrasonic probe comprising:

a proximal end, a distal end and a longitudinal axis therebetween;

a proximal section located proximal to the distal end; and

a flexible section located between the distal end and the proximal section, wherein the flexible section comprises a diameter smaller than both a diameter of the proximal section of the ultrasonic probe and a diameter of the distal end of the ultrasonic probe.

76. The ultrasonic probe of claim 75 wherein the flexible section comprises a flexibility that allows the ultrasonic probe to deflect without affecting the mechanical or ultrasonic properties of the ultrasonic probe.

77. The ultrasonic probe of claim 75 wherein the small diameter flexible section allows greater flexibility for bending the ultrasonic probe.

78. The ultrasonic probe of claim 75 wherein a diameter of the ultrasonic probe decreases from the proximal section to the flexible section over a diameter transition.

79. The ultrasonic probe of claim 75 wherein a diameter of the ultrasonic probe increases from the flexible section to the distal end over a diameter transition.

80. The ultrasonic probe of claim 75 wherein a diameter of the ultrasonic probe gradually tapers from a larger diameter of the proximal section of the ultrasonic probe to a smaller diameter of the flexible section of the ultrasonic probe.

81. The ultrasonic probe of claim 75 wherein a diameter of the ultrasonic probe gradually tapers from a smaller diameter of the flexible section of the ultrasonic probe to a larger diameter of the distal end of the ultrasonic probe.

82. The ultrasonic probe of claim 75 wherein a plurality of transverse nodes and a plurality of transverse anti-nodes caused by a transverse ultrasonic vibration of the ultrasonic probe are located along the flexible section, the proximal section and the distal end of the ultrasonic probe.