FOCUSED ULTRASONIC RENAL DENERVATION

• US 20110257523A1
• Filed: 04/13/2011
• Published: 10/20/2011
• Est. Priority Date: 04/14/2010
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Inventors: Hastings, Roger, Shuros, Allan C., Ingle, Frank, Hollingsworth, Mark
• Granted Patent: US 9,192,790 B2
• Time in Patent Office: Days
• US Class Current: 600/439
• CPC Class Codes: A61B 18/0206 ultrasonic, e.g. for destroying tissue or enhancing freezing
• CPC Class Codes: A61B 2018/00404 Blood vessels other than those in or around the heart
• CPC Class Codes: A61B 2018/00434 Neural system
• CPC Class Codes: A61B 2018/00511 Kidney
• CPC Class Codes: A61B 2090/3784 both receiver and transmitter being in the instrument or receiver being also transmitter
• CPC Class Codes: A61B 8/0891 for diagnosis of blood vessels
• CPC Class Codes: A61B 8/12 in body cavities or body tracts, e.g. by using catheters catheters per se A61M25/00
• CPC Class Codes: A61B 8/4488 the transducer being a phased array
• CPC Class Codes: A61N 2007/003 Destruction of nerve tissue
• CPC Class Codes: A61N 2007/0095 by modifying an excitation signal
• CPC Class Codes: A61N 7/022 intracavitary

Abstract

Acoustic energy is delivered to innervated vascular that contributes to renal sympathetic nerve activity, such as innervated tissue of the renal artery and abdominal aorta. Focused acoustic energy is delivered via an intravascular device of sufficient power to ablate innervated renal or aortal tissue. Focused acoustic energy may be delivered via an intravascular or extracorporeal device to image and locate target innervated renal or aortal tissue. Intravascular, extravascular, or transvascular focused ultrasound devices provide for high precision denervation of innervated vascular to terminate renal sympathetic nerve activity.

Claims

1. An apparatus, comprising:

a catheter configured for deployment within a vessel proximate innervated tissue that contributes to renal sympathetic nerve activity;

an acoustic transducer provided at a distal end of the catheter and dimensioned for deployment within the vessel proximate the innervated tissue;

a focusing arrangement configured to focus acoustic energy outwardly beyond an inner wall of the vessel and into the innervated tissue at or proximate an outer wall of the vessel; and

a controller configured to control the acoustic transducer for at least one of scanning tissue and ablating the innervated tissue.

2. The apparatus of claim 1, wherein the controller is configured to control the acoustic transducer to selectively scan tissue and ablate the innervated tissue.

3. The apparatus of claim 1, wherein the acoustic transducer comprises an acoustic phased array transducer, the phased array transducer comprising:

a plurality of acoustic elements; and

driver electronics coupled to the acoustic elements;

further wherein the controller is coupled to the driver electronics and configured to control activation of each of the acoustic elements of the phased array transducer for at least one of scanning tissue and ablating the innervated tissue.

4. The apparatus of claim 3, wherein the controller is configured to control activation the acoustic elements of the phased array transducer for selectively scanning tissue and ablating the innervated tissue.

5. The apparatus of claim 1, wherein the acoustic transducer comprises a high-intensity focused ultrasound (HIFU) transducer.

6. The apparatus of claim 1, wherein the acoustic transducer comprises a linear phased array transducer.

7. The apparatus of claim 1, wherein the acoustic transducer comprises a curvilinear or a convex sector phased array transducer.

8. The apparatus of claim 1, wherein:

the acoustic transducer comprises an acoustic phased array transducer; and

the controller is configured to electronically adjust a focal length of the phased array transducer consistent with a distance between the phased array transducer and the innervated tissue.

9. The apparatus of claim 1, wherein the acoustic transducer and focusing arrangement cooperate to focus acoustic energy at foci at a desired depth within the innervated tissue of sufficient intensity to ablate the innervated tissue while negligibly injuring inner wall tissue of the vessel.

10. The apparatus of claim 1, wherein the acoustic transducer and focusing arrangement cooperate to focus acoustic energy at foci of spherical or cylindrical geometries at a desired depth within the innervated tissue in each of a first mode and a second mode, the first mode associated with acoustic energy of an intensity for scanning innervated tissue, and the second mode associated with acoustic energy of an intensity for ablating the innervated tissue.

11. The apparatus of claim 1, wherein the acoustic transducer is configured to generate an acoustic power level corresponding to focal peak intensities equal to or greater than about 2000 W/cm² in the innervated tissue.

12. The apparatus of claim 1, wherein the acoustic transducer is configured for high intensity focused ultrasound operation in a cavitation ablation mode that produces bubbles within the innervated tissue that work to mechanically disrupt nerve fibers and ganglia included within the innervated tissue upon bursting.

13. The apparatus of claim 1, comprising a balloon configured to encompass at least the acoustic transducer.

14. The apparatus of claim 13, wherein the balloon is configured to receive a liquid that provides good acoustic coupling between the acoustic transducer and a wall of the balloon.

15. The apparatus of claim 13, wherein the balloon is configured to facilitate cooling of an inner wall of the vessel by one or both of a blood perfusion arrangement or an arrangement for receiving a thermal transfer fluid.

16. An apparatus, comprising:

a catheter configured for deployment within a vessel proximate innervated tissue;

an acoustic transducer provided at a distal end of the catheter and dimensioned for deployment within the vessel;

a focusing arrangement configured to focus acoustic energy outwardly beyond an inner wall of the vessel and into the innervated tissue at or proximate an outer wall of the vessel; and

a cryoballoon dimensioned for deployment within the vessel and configured to freeze the innervated tissue;

wherein the acoustic transducer and focusing arrangement cooperate to deliver acoustic energy to frozen innervated tissue at an intensity sufficient to disrupt nerve cells of the innervated tissue.

17. The apparatus of claim 16, wherein at least the acoustic transducer is encompassed by the cryoballoon.

18. The apparatus of claim 16, wherein the acoustic transducer, the focusing arrangement, and the cryoballoon are supported by a common shaft.

19. The apparatus of claim 16, wherein at least the acoustic transducer and the cryoballoon each comprise a respective support shaft.

20. The apparatus of claim 16, wherein the acoustic transducer is configured to operate at a power level corresponding to a focal peak intensity sufficient to produce cavitation bubbles within the innervated tissue that break nerve sheaths of the innervated tissue.

21. The apparatus of claim 16, wherein the transducer is configured to operate at a power level corresponding to a focal peak intensity sufficient to produce coagulative necrosis in the innervated tissue.

22. The apparatus of claim 16, wherein the innervated vasculature comprises innervated tissue of the renal artery or ganglia of the abdominal aorta that contribute to renal sympathetic nerve activity.