Ultrasonic device for tissue ablation and sheath for use therewith

• US 6,524,251 B2
• Filed: 02/15/2001
• Issued: 02/25/2003
• 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): Walberg, Teresa
• Assistant Examiner(s): Fuqua, Shawntina T.
• Application Number:
  US09/784,619
• Publication Number:
  US 20020107446A1
• Time in Patent Office: 740 Days
• Field of Search: 600/439, 600/459, 600/462-464, 600/466-467, 600/471-472, 604/20-22, 604/169-171, 606/159, 606/167
• US Class Current: 600/439
• 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 2017/320098 with transverse or torsional motion
• 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 transverse mode ultrasonic probe is provided which creates a cavitation area along its longitudinal length, increasing the working surface of the probe. Accessory sheaths are also provided for use with the probe to enable a user to select from features most suited to an individual medical procedure. The sheaths provide acoustic enhancing and aspiration enhancing properties, and/or can be used as surgical tools or as medical access devices, protecting tissue from physical contact with the probe.

Claims

1. An ultrasonic device for tissue ablation comprising:

an elongate probe body having a proximal end, a distal end and at least two regions of differing cross-sectional dimension;

an oscillating flexible probe tip at the distal end of the probe body having a cross-sectional dimension smaller than the proximal end;

a transducer contained in a probe handle capable of vibrating at an ultrasonic frequency coupled to the probe body;

an adapting mechanism mechanically coupling the transducer to the probe body to enable translation of vibrations from said transducer to the probe, causing a length of the probe body including the probe tip to be oscillated transversely to its longitudinal axis; and

a sheath assembly adapted to said probe comprising at least one sheath,

wherein the probe body emits a transverse ultrasonic energy along the length of the probe body so that a plurality of transverse nodes and anti-nodes are formed along the length of the probe body.

2. The ultrasonic device of claim 1 wherein the sheath assembly covers at least a portion of the probe, said sheath assembly comprising a longitudinally extending structural wall that defines a longitudinally extending hollow interior for accommodating at least a portion of said probe, wherein said structural wall of said sheath assembly is substantially self supporting so that the said structural wall maintains substantially the same shape with said probe disposed in the said hollow interior as without said probe disposed in the said hollow interior.

3. The ultrasonic device of claim 1 wherein the sheath assembly substantially prevents transmission of cavitational energy generated by the probe to the surrounding environment.

4. The ultrasonic device of claim 1 wherein the sheath assembly further comprises at least one fenestration.

5. The ultrasonic device of claim 4 wherein the fenestration is capable of transmitting cavitation energy therethrough to surrounding environment.

6. The ultrasonic device of claim 1 wherein the sheath assembly further comprises one or more devices capable of manipulating tissue.

7. The ultrasonic device of claim 1 wherein the sheath assembly further comprises at least one reflective element.

8. The ultrasonic device of claim 1 wherein said sheath assembly further comprises at least one irrigation channel.

9. The ultrasonic device of claim 1 wherein said sheath assembly further comprises at least one aspiration channel.

10. The ultrasonic device of claim 1 wherein said sheath assembly further comprises at least one channel for delivering a therapeutic agent therethrough.

11. The ultrasonic device of claim 1 wherein said sheath assembly further comprises an imaging device.

12. The ultrasonic device of claim 1 wherein the sheath assembly is adapted for use with an imaging system.

13. The ultrasonic device of claim 1 wherein the device is part of a kit for removing an occlusion in a vessel, and said kit further comprising a container capable of retaining the said probe and sheath assembly, and appropriate packaging to contain and maintain the sterility of the contents.

14. A kit of claim 13 wherein the ultrasonic device and sheath assembly are pre-assembled in a preferred configuration.

15. A method of modulating, focusing and directing cavitation energy emitted from a ultrasonic probe coupled a transducer capable of providing an ultrasonic excitation signal to said probe, vibrating in a transverse mode for tissue ablation comprising:

enclosing at least a portion of the probe within a sheath assembly having at least one fenestration;

inserting the probe of an ultrasonic medical device into a blood vessel;

guiding the probe and the enclosing sheath assembly into the blood vessel up to a site of an occlusion;

positioning said probe and the sheath assembly such that the fenestration is in proximity with the occlusion causing materials;

providing an ultrasonic electrical excitation signal to said ultrasonic medical device and transferring the signal along a length of the probe to a flexible probe tip, thereby causing transverse vibration of the length of said probe and the generation of a plurality of nodes of a cavitation energy along the length of said probe; and

controlling the selective transmission of the cavitation energy through the fenestration in the sheath assembly, thereby directing said energy specifically in an occluded area within the blood vessel to cause fragmentation of the occlusion causing materials.

16. The method of claim 15 wherein the sheath assembly is capable of partially shielding the tissues at the site of a surgical procedure from said probe.

17. The method of claim 15 wherein the sheath assembly further comprises an aspiration conduit, whereby fragments of the occlusion causing materials are removed through said conduit.

18. The method of claim 15 wherein the sheath assembly further comprises an irrigation conduit, and enabling supply of an irrigating fluid to the site of the occlusion causing material removal.

19. The method of claim 15 wherein the sheath assembly further comprises a conduit for delivering a therapeutic agent therethrough.

20. The method according to claim 15 wherein the sheath assembly further comprises an imaging system enabling positioning of said probe proximal to said occlusion.

21. The method of claim 15 wherein the sheath assembly further comprises a tissue manipulation device.

22. The method of claim 15 wherein the sheath assembly shields ultrasound energy emitted from said probe thereby increasing the resolution of said surgical site when visualized by an ultrasound imaging system.

23. The method of claim 15 wherein the sheath assembly is used for guiding the ultrasonic probe to a surgical site further comprising:

introducing the sheath assembly from an exterior of a patient to the site of the occlusion, and

introducing the ultrasonic probe into said sheath assembly.