Apparatus and method of removing occlusions using ultrasonic medical device operating in a transverse mode

• US 6,652,547 B2
• Filed: 02/02/2001
• Issued: 11/25/2003
• Est. Priority Date: 10/05/1999
• Status: Expired due to Term

• Current Assignee: Cybersonics, Inc
• Original Assignee: OmniSonics Medical Technologies, Inc.
• Inventors: Rabiner, Robert, Hare, Bradley A.
• Primary Examiner(s): Calvert, John J.
• Assistant Examiner(s): HURLEY, SHAUN R
• Application Number:
  US09/776,015
• Publication Number:
  US 20020077643A1
• Time in Patent Office: 1,026 Days
• Field of Search: 604/22, 604/95.03, 604/509, 606/159, 606/169-171, 606/192, 601/2, 601/4
• 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 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 2017/00137 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 2017/320069 for ablating tissue
• CPC Class Codes: A61B 2017/32007 with suction or vacuum means
• 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: A61M 1/85 with gas or fluid supply means, e.g. for supplying rinsing fluids or anticoagulants for negative pressure wound therapy A61M1/92, A61M1/94; combined with tracheal tubes A61M16/0463; dental instruments with combined rinsing and aspirating A61C17/0208
• CPC Class Codes: A61N 2007/0008 : Destruction of fat cells
• CPC Class Codes: A61N 7/022 : intracavitary

Abstract

A method for removing an occlusion is provided comprising introducing a transverse mode ultrasonic probe into a blood vessel, positioning the probe in proximity to the occlusion, and transmitting ultrasonic energy to the probe, until the occlusion is removed. The probe has a small cross-sectional lumen and is articulable for navigating in a tortuous vessel path. The probe can be used with acoustic and/or aspirations sheaths to enhance destruction and removal of an occlusion. The probe can also be used with a balloon catheter. The probe, sheaths, and catheter can be provided in a sharps container which further provides a means of affixing and detaching the probe from an ultrasonic medical device.

Claims

1. An ultrasonic medical device for removing vascular occlusions comprising:

a transducer capable of vibrating at an ultrasonic frequency, a probe engaging said transducer, said probe capable of translating the vibrations from said transducer and thereby vibrating transversely along its longitude thus creating a plurality of nodes of cavitation energy along at least a portion of a longitudinal axis of said probe,

wherein said plurality of nodes of cavitation energy create an occlusion destroying effect along at least a portion of said longitudinal axis of said probe.

2. The ultrasonic medical device of claim 1 whereby said transverse vibration along said longitudinal axis of said probe further causes a node of cavitation energy at the distal end of said probe.

3. The ultrasonic medical device of claim 2 wherein the cavitation energy produced at the distal end of said probe is capable of fragmenting vascular occlusive material to sub-micron sized particles and is capable of effectuating retrograde flow of said fragmented vascular occlusive material away from the distal end of said probe.

4. The ultrasonic medical device of claim 2 further comprising a sheath engaging said probe.

5. The ultrasonic medical device of claim 4 wherein said sheath further comprises an aspiration means.

6. The ultrasonic medical device of claim 4 or claim 5 wherein said sheath further comprises an imaging means.

7. An ultrasonic medical device for removing vascular occlusions comprising:

a transducer capable of vibrating at an ultrasonic frequency, a probe engaging said transducer, said probe capable of translating the vibrations from said transducer and thereby vibrating transversely along at least a portion of a longitudinal axis thus creating a plurality of nodes of cavitation energy along at least a portion of said longitudinal axis of said probe wherein said plurality of nodes of cavitation energy create an occlusion destroying effect along at least a portion of said longitudinal axis of said probe, and a balloon catheter engaging a portion of said probe, said balloon catheter capable of being adapted to an inflation means and a deflation means.

8. The ultrasonic medical device of claim 7 further comprising a sheath engaging said probe.

9. The ultrasonic medical device of claim 8 wherein said sheath further comprises an aspiration means.

10. The ultrasonic medical device of claim 7 or claim 8 wherein said sheath further comprises an imaging means.

11. A kit for removing an occlusion in a vessel comprising:

a probe capable of vibrating transversely along a longitudinal axis thus creating a plurality of nodes of cavitation energy along at least a portion of said longitudinal axis of said probe wherein said plurality of nodes of cavitation energy create an occlusion destroying effect along at least a portion of said longitudinal axis of said probe; and

an appropriate packaging to contain and maintain the sterility of the contents of the kit.

12. The kit of claim 11 further comprising a sheath engaging said probe.

13. The kit of claim 11 or claim 12 further comprising a balloon catheter engaging a portion of said probe, said balloon catheter capable of being adapted to an inflation means and a deflation means.

14. A method of removing an occlusion from a vessel with an ultrasonic medical device capable of transverse vibration along at least a portion of a longitudinal axis of the probe of said device, comprising the steps of:

a) inserting a probe of an ultrasonic medical device into said vessel;

b) positioning said probe in proximity to said occlusion;

c) providing ultrasonic energy to said medical device thereby causing transverse vibration of said probe and the generation of a plurality of nodes of cavitation energy along at least a portion of said longitudinal axis of said probe wherein said plurality of nodes of cavitation energy create an occlusion destroying effect along at least a portion of said longitudinal axis of said probe; and

d) fragmenting said occlusion through the cavitation energy emitted by said probe.

15. The method of claim 14 wherein the probe is at least partially contained within a sheath further comprising at least one fenestration, said probe and sheath positioned such that said fenestration is in proximity with the occlusion.

16. The method of claim 15 wherein the sheath further comprises an aspiration means, and fragment of said occlusion generated from cavitation at the distal end of the probe are directed, in a retrograde direction from the distal end of said probe, said fragments remove through said aspiration means.

17. The method of claim 14 or claim 15 wherein the sheath further comprises an imaging means enabling the positioning of said probe proximal to said occlusion.

18. The method of claim 14 wherein the probe further comprises a balloon catheter engaging a portion of said probe, said balloon catheter capable of engaging an inflation means and a deflation means, and further comprising the steps of inserting the probe and balloon catheter into a vessel, positioning the balloon catheter proximal to the occlusion, inflating the balloon catheter so the balloon catheter contacts the surface of the occlusion, applying ultrasonic energy to said probe to fragment the occlusion, further inflating said balloon catheter to maintain contact with the occlusion while the occlusion is fragmented, deflating the balloon, and withdrawing the probe and balloon from the vessel.

19. An ultrasonic medical device for removing an occlusion in a blood vessel comprising:

an elongated, flexible probe having a first terminus, a second terminus and a longitudinal axis therebetween; and

a transducer coupled to said elongated, flexible probe at said first terminus wherein said transducer is capable of vibrating at an ultrasonic frequency to enable a translation of an acoustical energy from said transducer to said elongated, flexible probe, causing a transverse vibration along at least a portion of said longitudinal axis of said elongated, flexible probe creating an occlusion destroying effect along at least a portion of said longitudinal axis of said elongated, flexible probe.

20. The ultrasonic device of claim 19 further comprising a sheath assembly adapted to said elongated, flexible probe consisting of an at least one sheath.

21. The ultrasonic medical device of claim 20 wherein said sheath assembly further comprises an at least one irrigation channel.

22. The ultrasonic medical device of claim 20 wherein said sheath assembly further comprises an at least one aspiration channel.

23. The ultrasonic medical device of claim 20 wherein said sheath assembly further comprises an at least one channel for delivering a drug therethrough.

24. The ultrasonic medical device of claim 20 wherein said sheath assembly further comprises an imaging device.

25. The ultrasonic medical device of claim 20 wherein a flexibility of said elongated, flexible probe.

26. The ultrasonic medical device of claim 19 further comprising a balloon catheter engaging at least a portion of said elongated, flexible probe, said balloon catheter capable of being engaged to an inflation apparatus and a deflation apparatus.

27. The ultrasonic medical device of claim 26 further comprising a sheath assembly engaged to said elongated, flexible probe consisting of an at least one sheath.

28. The ultrasonic medical device of claim 19 wherein said transverse vibrations along at least a portion of said longitudinal axis of said elongated, flexible probe creates a plurality of nodes of cavitation-energy along at least a portion of said longitudinal axis of said elongated, flexible probe.

29. The ultrasonic medical device according to claim 28 wherein said nodes of cavitation energy are capable of disrupting an occlusive materials within said blood vessel and causing fragmentation of said materials.

30. The ultrasonic medical device according to claim 28 wherein said nodes of cavitation energy is capable of effectuating retrograde flow of said fragmented occlusive materials away from said second terminus of said elongated, flexible probe.

31. An ultrasonic medical device comprising:

an elongated flexible probe with a plurality of intervals each having a varying diameter along a longitudinal axis of the elongated, flexible probe;

a first terminus of the longitudinal axis having a largest diameter of the elongated, flexible probe; and

a second terminus of the longitudinal axis having a smallest diameter of the elongated, flexible probe;

wherein the elongated, flexible probe can support a transverse ultrasonic vibration along at least a portion of the longitudinal axis that causes an occlusion destroying effect along at least a portion of the longitudinal axis of the elongated, flexible probe.

32. The ultrasonic medical device of claim 31 wherein the elongated, flexible probe is disposable.

33. The ultrasonic medical device of claim 31 wherein a diameter transition is located between each of the plurality of intervals along the longitudinal axis of the elongated, flexible probe.

34. The ultrasonic medical device of claim 31 wherein the diameter of the elongated, flexible probe decreases in gradual steps at the intervals from the first terminus to the second terminus of the elongated, flexible probe.

35. The ultrasonic medical device of claim 31 wherein the diameter of the elongated, flexible probe decreases from the first terminus of the longitudinal axis of the elongated, flexible probe to the second terminus of the longitudinal axis of the elongated, flexible probe.

36. The ultrasonic medical device of claim 31 further comprising a disposable sheath.

37. The ultrasonic medical device of claim 31 wherein a flexibility of the elongated probe allows the probe to be articulated.