Method and apparatus for treatment of hypertension through percutaneous ultrasound renal denervation

• US 9,981,108 B2
• Filed: 10/29/2010
• Issued: 05/29/2018
• Est. Priority Date: 10/30/2009
• Status: Active Grant

• Current Assignee: Recor Medical, Inc. (Otsuka Holdings Company Limited)
• Original Assignee: Recor Medical, Inc. (Otsuka Holdings Company Limited)
• Inventors: Warnking, Reinhard J.
• Primary Examiner(s): CHEN, TSE W
• Assistant Examiner(s): Hoffman, Joanne
• Application Number:
  US13/503,109
• Publication Number:
  US 20120232436A1
• Time in Patent Office: 2,769 Days
• Field of Search: 600407-480, 601 1- 2
• CPC Class Codes: A61B 2017/003 Steerable
• CPC Class Codes: A61B 2017/00323 Cables or rods
• CPC Class Codes: A61B 2017/22021 electric leads passing through the catheter
• CPC Class Codes: A61B 2018/00023 closed, i.e. without wound contact by the fluid
• CPC Class Codes: A61M 2025/1047 having centering means, e.g. balloons having an appropriate shape
• CPC Class Codes: A61M 2025/1068 having means for varying the length or diameter of the deployed balloon, this variations could be caused by excess pressure
• CPC Class Codes: A61M 2025/1086 having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves
• CPC Class Codes: A61M 2025/1093 having particular tip characteristics
• CPC Class Codes: A61M 25/0068 Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
• CPC Class Codes: A61M 25/0082 Catheter tip comprising a tool
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61N 2007/0026 Stimulation of nerve tissue
• CPC Class Codes: A61N 2007/0043 intra-cavitary
• CPC Class Codes: A61N 7/00 Ultrasound therapy lithotripsy A61B17/22, A61B17/225; massage using supersonic vibration A61H23/00 ; using ultrasound for introducing media into the body A61M37/0092
• CPC Class Codes: A61N 7/022 intracavitary

Abstract

Apparatus and methods for deactivating renal nerves extending along a renal artery of a mammalian subject to treat hypertension and related conditions. An ultrasonic transducer (30) is inserted into the renal artery (10) as, for example, by advancing the distal end of a catheter (18) bearing the transducer into the renal artery. The ultrasonic transducer emits unfocused ultrasound so as to heat tissues throughout a relatively large impact volume (11) as, for example, at least about 0.5 cm3 encompassing the renal artery to a temperature sufficient to inactivate nerve conduction but insufficient to cause rapid ablation or necrosis of the tissues. The treatment can be performed without locating or focusing on individual renal nerves.

Claims

1. Apparatus for inactivating renal nerve conduction in a mammalian subject comprising:

a catheter comprising a distal end configured to be inserted into a renal artery of the mammalian subject;

an ultrasound transducer positioned along the distal end of the catheter, the ultrasound transducer configured to be inserted into the renal artery of the mammalian subject;

an actuator electrically connected to the ultrasound transducer, the actuator configured to cause the ultrasound transducer to emit a therapeutic dose of unfocused ultrasound energy simultaneously in a 360°

arc through an intima layer of the renal artery and into an impact volume disposed in an adventitia layer comprising renal nerves of the renal artery to inactivate conduction of the renal nerves throughout the impact volume without causing damage to the intima layer of the renal artery; and

a balloon mounted to the catheter to surround the ultrasound transducer, the balloon configured to engage a wall of the renal artery and, when inflated, to center the ultrasound transducer within the renal artery, the balloon further configured to receive a liquid delivered to the balloon to cool the intima layer of the renal artery.

2. The apparatus of claim 1, wherein the ultrasound transducer is configured to emit the therapeutic dose of unfocused ultrasound energy to maintain a temperature of the wall of the renal artery below 65°

C. while achieving a temperature above 42°

C. throughout the impact volume.

3. The apparatus of claim 1, wherein the ultrasound transducer is configured to emit the therapeutic dose of unfocused ultrasound energy to inactivate conduction of the renal nerves along a length of 2 mm to 10 mm along an axis of the renal artery.

4. The apparatus of claim 1, wherein the ultrasound transducer is configured to emit the therapeutic dose of unfocused ultrasound energy throughout the impact volume having a length of 2 mm to 10 mm along an axis of the renal artery.

5. The apparatus of claim 1, wherein the catheter and the ultrasound transducer are constructed and arranged to allow a flow of blood through the renal artery while the ultrasound transducer is positioned within the renal artery.

6. The apparatus of claim 1, wherein the catheter is constructed and arranged to hold the ultrasound transducer out of contact with the wall of the renal artery.

7. The apparatus of claim 1, wherein the ultrasound transducer has an axis, the catheter is constructed and arranged to hold the axis of the ultrasound transducer generally parallel to an axis of the renal artery, and the ultrasound transducer is configured to emit the therapeutic dose of unfocused ultrasound energy simultaneously in the 360°

arc such that the therapeutic dose is emitted in a 360°

cylindrical pattern surrounding the axis of the ultrasound transducer.

8. The apparatus of claim 1, wherein the ultrasound transducer is configured to emit the therapeutic dose of unfocused ultrasound energy throughout the impact volume at a level insufficient to cause necrosis of tissues.

9. The apparatus of claim 1, wherein the impact volume encompasses all of the renal nerves surrounding the renal artery.

10. The apparatus of claim 1, wherein the ultrasound transducer is configured to emit the therapeutic dose of unfocused ultrasound energy at a frequency of 1 to 30 MHz.

11. The apparatus of claim 1, wherein the ultrasound transducer is further configured to receive ultrasound energy and generate a signal representing the received ultrasound energy.

12. The apparatus of claim 1, wherein the balloon comprises a circular profile.

13. The apparatus of claim 1, wherein the actuator is configured to be releasably coupled to a proximal end of the catheter.

14. The apparatus of claim 1, wherein the actuator comprises a circulation device configured to deliver the liquid to the balloon through the catheter to inflate the balloon.

15. The apparatus of claim 14, wherein the circulation device comprises a tank configured to hold the liquid and a pump configured to pump the liquid from the tank to the balloon through the catheter.

16. The apparatus of claim 1, wherein the actuator comprises a programmable microprocessor and an ultrasound excitation source, the programmable microprocessor configured to cause the ultrasound excitation source to electrically excite the ultrasound transducer to cause the ultrasound transducer to emit the therapeutic dose of unfocused ultrasound energy.

17. The apparatus of claim 1, wherein the actuator comprises a user interface.

18. The apparatus of claim 1, wherein the impact volume is generally cylindrical and coaxial with the renal artery.

19. The apparatus of claim 1, wherein the actuator is configured to be releasably coupled to a proximal end of the catheter, the actuator comprising a circulation device, a programmable microprocessor, an ultrasound excitation source, and a user interface, the circulation device comprising a tank configured to hold the liquid and a pump configured to pump the liquid from the tank to the balloon through the catheter, wherein the programmable microprocessor is configured to cause the ultrasound excitation source to electrically excite the ultrasound transducer to cause the ultrasound transducer to emit the therapeutic dose of unfocused ultrasound energy.

20. The apparatus of claim 1, further comprising a machine-readable element affixed to the catheter, the machine-readable element configured to encode an actuation frequency of ultrasound energy to be emitted by the ultrasound transducer during use.

21. The apparatus of claim 1, wherein the liquid delivered to the balloon comprises a radiographic contrast agent.

22. The apparatus of claim 1, wherein the balloon comprises a non-circular profile.

23. The apparatus of claim 1, wherein the ultrasound transducer is further configured to be repositioned in the renal artery and configured to emit another therapeutic dose of unfocused ultrasound energy.

24. The apparatus of claim 1, wherein the ultrasound transducer is further configured to be inserted in another renal artery and configured to emit another therapeutic dose of unfocused ultrasound energy in the other renal artery.

25. The apparatus of claim 1, wherein the ultrasound transducer is configured to emit the therapeutic dose of unfocused ultrasound energy at a power level of 10 to 30 watts for 2 to 30 seconds.