Apparatus for removing plaque from blood vessels using ultrasonic energy

• US 6,660,013 B2
• Filed: 10/05/2001
• Issued: 12/09/2003
• Est. Priority Date: 10/05/1999
• Status: Expired due to Term

• Current Assignee: Cybersonics, Inc
• Original Assignee: OmniSonics Medical Technologies, Inc.
• Inventors: Rabiner, Robert A., Hare, Brad A.
• Primary Examiner(s): Robert, Eduardo C.
• Assistant Examiner(s): Bonderer, D. Austin
• Application Number:
  US09/972,555
• Publication Number:
  US 20030069590A1
• Time in Patent Office: 795 Days
• Field of Search: 606/128, 606/127, 606/110, 606/114, 606/115, 606/166, 606/169, 606/170, 604/22
• US Class Current: 606/128
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• 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 2017/22002 preventing restenosis
• 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 2017/293 with means preventing relative rotation between the shaft and the actuating rod
• CPC Class Codes: A61B 2017/320073 probe
• CPC Class Codes: A61B 2017/320084 Irrigation sleeves
• CPC Class Codes: A61B 2217/005 with suction drainage system
• CPC Class Codes: A61B 2217/007 with irrigation system

Abstract

A method and apparatus for removing plaque, fatty deposits, and other occlusions from blood vessels using ultrasonic energy. The method and apparatus has particular application in removing plaque from the carotid artery in a non-thermal manner. The apparatus is designed to have as small a cross-sectional profile as possible, therefore allowing the apparatus to be used in a minimally-invasive manner. As a result, the apparatus can be used in both surgical and outpatient treatment with minimal post-operative complications and minimal damage to areas other than the area of treatment. An ultrasonic probe may include aspiration channels on its outer surface. An aspiration sheath may surround the ultrasonic probe, such that the location of an aspiration port may be varied axially relative to the ultrasonic tip.

Claims

1. An ultrasonic apparatus for removing plaque from a blood vessel comprising:

an elongate probe having proximal and distal extremities, the elongate probe being sized so that it can be introduced into a blood vessel and having a length so that when the distal extremity is disposed in the vicinity of a plaque on the inner surface of the vessel the proximal extremity is outside of a body of a treated patient, the elongate probe having a passage extending from the proximal extremity to the distal extremity;

a probe tip disposed in the passage, the probe tip being capable of conducting ultrasonic energy into the plaque on the vessel for cavitating the plaque;

an ultrasonic generator which is capable of delivering ultrasonic energy to the probe and into the plaque to debulk the vessel by reduction of the plaque to a particulate material;

a handle coupled to the proximal extremity of the elongate probe, wherein a plurality of transverse anti-nodes along at least a portion of the length of the elongate probe create a plaque destroying effect along at least a portion of the length of the elongate probe.

2. The apparatus according to claim 1 further comprising:

fenestrations disposed along the length of the probe for use in at least one of irrigation and aspiration.

3. The apparatus according to claim 1 wherein:

the ultrasonic generator is configured to run at about 20 kHz.

4. The device of claim 1 wherein the elongate probe comprises an at least one channel for aspiration of the particulate material from a treatment site.

5. The device of claim 1 wherein the ultrasonic generator generates a transverse ultrasonic vibration along a portion of the length of the elongate probe.

6. The device of claim 1 wherein a transverse ultrasonic vibration is transmitted from the ultrasonic generator to the elongate probe through an ultrasonic coupler.

7. The device of claim 1 wherein the ultrasonic generator engages the proximal extremity of the elongate probe through an ultrasonic coupler.

8. The device of claim 1 wherein the elongate probe is axially movably mounted within an aspiration sheath.

9. The device of claim 1 wherein the elongate probe vibrates in a direction transverse to at least a portion of the length of the elongate probe.

10. The device of claim 1 wherein a transverse ultrasonic vibration of the elongate probe provides a plurality of transverse anti-nodes along at least a portion of the length of the elongate probe.

11. The device of claim 1 wherein a transverse ultrasonic vibration of the elongate probe creates a plaque destroying effect along at least a portion of the length of the elongate probe.

12. The device of claim 1 wherein the elongate probe reduces the plaque to the particulate material having a diameter of approximately 10 microns or less.

13. An ultrasonic medical device for destroying a plaque within a blood vessel comprising:

a probe having a distal end, a proximal end and an axial length therebetween;

a diameter of the probe that is tapered from the proximal end of the probe to the distal end of the probe; and

an ultrasonic generator that engages the proximal end of the probe to deliver an ultrasonic energy to the probe,

wherein the probe supports a transverse ultrasonic vibration creating a plurality of transverse anti-nodes causing a plaque destroying effect along at least a portion of the axial length of the probe to destroy the plaque within the blood vessel.

14. The device of claim 13 wherein the ultrasonic generator produces the transverse ultrasonic vibration along a portion of the axial length of the probe.

15. The device of claim 13 wherein the transverse ultrasonic vibration of the probe creates a plaque destroying effect along at least a portion of the axial length of the probe.

16. The device of claim 13 wherein a transmission of the ultrasonic energy to the probe is at a power level to reduce the plaque to a particulate material having a diameter of approximately 10 microns or less.

17. The device of claim 13 wherein the transverse ultrasonic vibration is transmitted from the ultrasonic generator to the probe through an ultrasonic coupler.

18. The device of claim 13 wherein the ultrasonic generator engages the proximal end of the probe through an ultrasonic coupler.

19. The device of claim 13 wherein the probe has a small cross sectional profile.

20. The device of claim 13 wherein the probe is axially movably mounted within an aspiration sheath.

21. The device of claim 13 further comprising a probe tip capable of moving axially inward and outward relative to a distal end of an aspiration sheath.

22. The device of claim 13 wherein the probe comprises a channel for aspiration of a particulate material from the blood vessel.

23. The device of claim 13 wherein the probe vibrates in a direction transverse to at least a portion of the axial length of the probe.

24. The device of claim 13 wherein the transverse ultrasonic vibration of the probe provides a plurality of transverse anti-nodes along at least a portion of the axial length of the probe.

25. The device of claim 24 wherein the transverse anti-nodes are points of a maximum transverse ultrasonic vibration along at least a portion of the axial length of the probe.

26. The device of claim 13 wherein a flexibility of the probe allows the probe to be articulated within the blood vessel.

27. An ultrasonic medical device for ablating a plaque within a blood vessel comprising:

a flexible probe having a distal end, a proximal end and an axial length therebetween;

a probe tip extending from the distal end of the flexible probe; and

an ultrasonic generator that engages the proximal end of the flexible probe to deliver an ultrasonic energy along the axial length of the flexible probe,

wherein the flexible probe is capable of flexing to support a transverse ultrasonic vibration creating a plurality of transverse anti-nodes causing a plaque destroying effect along at least a portion of the axial length of the flexible probe.

28. The device of claim 27 wherein the ultrasonic generator produces the transverse ultrasonic vibration along a portion of the axial length of the flexible probe.

29. The device of claim 27 wherein the transverse ultrasonic vibration of the flexible probe creates a plaque ablating effect along at least a portion of the axial length of the flexible probe.

30. The device of claim 27 wherein a transmission of the ultrasonic energy to the flexible probe is at a power level to reduce the plaque to a particulate material having a diameter of approximately 10 microns or less.

31. The device of claim 27 wherein the transverse ultrasonic vibration is transmitted from the ultrasonic generator to the flexible probe through an ultrasonic coupler.

32. The device of claim 27 wherein the ultrasonic generator engages the proximal end of the flexible probe through an ultrasonic coupler.

33. The device of claim 27 wherein the flexible probe has a small cross sectional profile.

34. The device of claim 27 wherein the flexible probe is axially movably mounted within an aspiration sheath.

35. The device of claim 27 wherein the probe tip is capable of moving axially inward and outward relative to a distal end of an aspiration sheath.

36. The device of claim 27 wherein the flexible probe comprises a channel for aspiration of a particulate material from the blood vessel.

37. The device of claim 27 wherein the flexible probe vibrates in a direction transverse to at least a portion of the axial length of the flexible probe.

38. The device of claim 27 wherein the transverse ultrasonic vibration of the flexible probe provides a plurality of transverse anti-nodes along at least a portion of the axial length of the flexible probe.

39. The device of claim 38 wherein the transverse anti-nodes are points of a maximum transverse ultrasonic vibration along at least a portion of the axial length of the flexible probe.

40. The device of claim 27 wherein a flexibility of the flexible probe allows the flexible probe to be articulated within the blood vessel.