Apparatus and method for an ultrasonic medical device with a non-compliant balloon

• US 20040249401A1
• Filed: 05/14/2004
• Published: 12/09/2004
• Est. Priority Date: 10/05/1999
• Status: Abandoned Application

• Current Assignee: Cybersonics, Inc
• Original Assignee: OmniSonics Medical Technologies, Inc.
• Inventors: Rabiner, Robert A., Hare, Bradley A.
• Application Number:
  US10/846,037
• Publication Number:
  US 20040249401A1
• Time in Patent Office: Days
• US Class Current: 606/159
• 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 2017/00137 Details of operation mode
• CPC Class Codes: A61B 2017/00274 Prostate operation, e.g. prostatectomy, turp, bhp treatment
• CPC Class Codes: A61B 2017/22007 Cavitation or pseudocavitation, i.e. creation of gas bubbles generating a secondary shock wave when collapsing
• CPC Class Codes: A61B 2017/22008 used or promoted
• CPC Class Codes: A61B 2017/22015 with details of the transmission member
• CPC Class Codes: A61B 2017/22018 segmented along its length
• CPC Class Codes: A61B 2017/22051 with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation A61B2017/22048, A61B2017/3486 take precedence
• CPC Class Codes: A61B 2017/320069 for ablating tissue
• CPC Class Codes: A61B 2017/320084 Irrigation sleeves
• CPC Class Codes: A61B 2017/320089 node location
• CPC Class Codes: A61B 2018/00547 Prostate
• CPC Class Codes: A61B 2018/00982 combined with or comprising means for visual or photographic inspections inside the body, e.g. endoscopes
• CPC Class Codes: A61B 2217/005 with suction drainage system
• CPC Class Codes: A61B 2217/007 with irrigation system
• CPC Class Codes: A61N 7/022 intracavitary

Abstract

The present invention provides an apparatus and a method for an ultrasonic medical device with a non-compliant balloon used to ablate a biological material. The ultrasonic medical device comprises an ultrasonic probe, a catheter surrounding the ultrasonic probe, a balloon supported by the catheter and an inflation lumen located along a longitudinal axis of the catheter. The ultrasonic probe is inserted into a vasculature and the catheter comprising the balloon is advanced until the balloon is adjacent to the biological material. The balloon is inflated until at least a portion of an outer surface of the balloon engages the biological material. The ultrasonic probe is energized to produce a transverse ultrasonic vibration that vibrates at least a portion of the balloon to ablate the biological material into a particulate.

Claims

1. An ultrasonic medical device comprising:

an ultrasonic probe having a proximal end, a distal end and a longitudinal axis therebetween;

a catheter surrounding the ultrasonic probe, the catheter having a proximal end, a distal end and longitudinal axis therebetween;

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

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

2. The device of claim 1 wherein the ultrasonic probe extends from the proximal end of the catheter to the distal end of the catheter.

3. The device of claim 1 wherein the balloon engages the catheter at an at least one engagement position along the longitudinal axis of the catheter.

4. The device of claim 1 wherein the inflation lumen comprises an at least one inflation opening along a longitudinal axis of the inflation lumen.

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

6. The device of claim 1 wherein the catheter comprises an at least one fenestration along the longitudinal axis of the catheter.

7. The device of claim 1 wherein a transverse ultrasonic vibration from the ultrasonic probe vibrates at least a portion of the balloon.

8. The device of claim 1 wherein the balloon concentrates a transverse ultrasonic energy from the ultrasonic probe.

9. The device of claim 1 wherein the balloon expands a treatment area of a biological material destroying effect of the ultrasonic probe.

10. The device of claim 1 wherein the balloon increases a radial span of a biological material destroying effect of the ultrasonic probe.

11. The device of claim 1 wherein at least a portion of an outer surface of the balloon engages a biological material.

12. The device of claim 1 wherein the balloon focuses a biological material destroying effect of the ultrasonic probe.

13. The device of claim 1 wherein the balloon adapts to a contour of a vasculature.

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

15. The device of claim 1 wherein a second balloon is located along the longitudinal axis of the catheter.

16. An ultrasonic medical device comprising:

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

a balloon having an outer surface, an inner surface, a proximal end and a distal end, the balloon engaging the catheter along the longitudinal axis of the catheter;

an elongated ultrasonic probe having a proximal end, a distal end and a longitudinal axis therebetween, the elongated ultrasonic probe extending through at least a portion of the longitudinal axis of the catheter; and

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

17. The device of claim 16 wherein the balloon is supported by the catheter between the proximal end and the distal end of the balloon.

18. The device of claim 16 wherein the inflation lumen comprises an at least one inflation opening along a longitudinal axis of the inflation lumen.

19. The device of claim 16 wherein the catheter comprises an at least one fenestration along the longitudinal axis of the catheter.

20. The device of claim 16 wherein the catheter surround at least a portion of the elongated ultrasonic probe.

21. The device of claim 16 wherein a transverse ultrasonic vibration from the elongated ultrasonic probe vibrates at least a portion of the balloon.

22. The device of claim 16 wherein the balloon expands a treatment area of an occlusion destroying effect of the elongated ultrasonic probe.

23. The device of claim 16 wherein the balloon focuses an occlusion destroying effect of the elongated ultrasonic probe.

24. The device of claim 16 wherein the balloon is a non-compliant balloon.

25. The device of claim 16 wherein a second balloon is located along the longitudinal axis of the catheter.

26. A method of ablating a biological material in a vasculature of a body comprising:

inserting an ultrasonic probe in the vasculature;

moving the ultrasonic probe adjacent to the biological material;

advancing a catheter comprising a balloon on an outer surface of the catheter over a longitudinal axis of the ultrasonic probe until the balloon is adjacent to the biological material;

inflating the balloon so at least a portion of an outer surface of the balloon engages the biological material;

energizing the ultrasonic probe to produce a transverse ultrasonic vibration that vibrates at least a portion of the balloon to ablate the biological material; and

inflating the balloon to a larger diameter to engage the biological material and energizing the ultrasonic probe to ablate the biological material.

27. The method of claim 26 further comprising repeatedly inflating the balloon to a larger diameter to engage the biological material and repeatedly energizing the ultrasonic probe to ablate the biological material.

28. The method of claim 26 wherein the balloon is inflated by providing a medium through an inflation lumen located within the catheter.

29. The method of claim 28 wherein the medium engages the inner surface of the balloon through an at least one inflation opening along a longitudinal axis of an inflation lumen.

30. The method of claim 26 wherein vibrating at least a portion of the ultrasonic probe by an ultrasonic energy source produces the transverse ultrasonic vibration along at least a portion of the balloon.

31. The method of claim 26 wherein the transverse ultrasonic vibration of the ultrasonic probe provides a plurality of transverse nodes and transverse anti-nodes along a portion of the longitudinal axis of the ultrasonic probe.

32. The method of claim 31 wherein the transverse anti-nodes are points of a maximum transverse energy along a portion of the longitudinal axis of the ultrasonic probe.

33. The method of claim 31 wherein the transverse anti-nodes cause a cavitation in a medium in communication with the ultrasonic probe in a direction not parallel to the longitudinal axis of the ultrasonic probe.

34. The method of claim 31 wherein more than one of the plurality of transverse anti-nodes are in communication with the biological material.

35. The method of claim 26 wherein the balloon transmits the transverse ultrasonic vibration to the biological material.

36. The method of claim 26 wherein the balloon concentrates a transverse ultrasonic energy to the biological material.

37. The method of claim 26 balloon expands a treatment area of a biological material destroying effect of the ultrasonic probe.

38. The method of claim 26 wherein the balloon increases a radial span of a biological material destroying effect of the ultrasonic probe.

39. The method of claim 26 wherein the balloon can support the transverse ultrasonic vibration along at least a portion of the longitudinal axis of the ultrasonic probe to ablate the biological material.

40. A method of removing an occlusion in a vasculature of a body comprising:

inserting a biocompatible material member inside the vasculature;

advancing the biocompatible material member in the vasculature until a portion of the biocompatible material member is adjacent to the occlusion;

moving a flexible ultrasonic probe through the biocompatible material member until the flexible ultrasonic probe is adjacent to the occlusion; and

activating an ultrasonic energy source to produce a transverse ultrasonic vibration along at least a portion of a longitudinal axis of the flexible ultrasonic probe that vibrates at least a portion of the biocompatible material member to remove the occlusion.

41. The method of claim 40 further comprising providing the biocompatible material member that is selected from the group consisting of a catheter, a balloon, a sheath, a heat sink and similar devices.

42. The method of claim 40 further comprising providing the biocompatible material member that has a proximal end and a distal end.

43. The method of claim 40 wherein at least the portion of an outer surface of the biocompatible material member engages the occlusion.

44. The method of claim 40 wherein the biocompatible material member increases a radial span of an occlusion destroying effect of the flexible ultrasonic probe.

45. The method of claim 40 wherein the biocompatible material member concentrates a transverse ultrasonic energy from the flexible ultrasonic probe to the occlusion.

46. The method of claim 40 wherein the transverse ultrasonic vibration of the flexible ultrasonic probe provides a plurality of transverse nodes and transverse anti-nodes along the portion of the longitudinal axis of the flexible ultrasonic probe.

47. The method of claim 40 wherein the occlusion comprises a biological material.

48. The method of claim 40 wherein the flexible ultrasonic probe and the biocompatible material member are for a single use on a single patient.

49. The method of claim 40 wherein the flexible ultrasonic probe and the biocompatible material member are disposable.