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

• US 10,039,901 B2
• Filed: 03/14/2013
• Issued: 08/07/2018
• 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, Richard J.
• Primary Examiner(s): Chen, Tse
• Assistant Examiner(s): HOFFMAN, JOANNE M
• Application Number:
  US13/826,645
• Publication Number:
  US 20140031727A1
• Time in Patent Office: 1,972 Days
• 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. A method for inactivating renal nerve conduction in a mammalian subject, the method comprising:

inserting an ultrasound transducer into a renal artery of the mammalian subject, wherein the ultrasound transducer is positioned along a distal end of a catheter, the catheter comprising a balloon mounted along the distal end of the catheter such that the ultrasound transducer is disposed within the balloon;

inflating the balloon such that the balloon engages an inner wall of the renal artery and the ultrasound transducer is positioned within the renal artery;

delivering cooled liquid to the balloon to cool an intima layer of the renal artery; and

actuating the ultrasound transducer to cause the ultrasound transducer to emit a therapeutic dose of unfocused ultrasound energy through the intima layer and into an impact volume of at least 0.5 cm³ disposed in an adventitia layer comprising renal nerves of the renal artery to inactivate conduction of the renal nerves in the impact volume without causing damage to the intima layer of the renal artery.

2. The method of claim 1, wherein actuating the ultrasound transducer to cause emission of the therapeutic dose of unfocused ultrasound energy is performed so as to maintain a temperature of the inner wall of the renal artery below 65°

C. while heating the renal nerves in the impact volume to above 42°

C.

3. The method of claim 1, wherein inserting the ultrasound transducer and actuating the ultrasound transducer to cause emission of the therapeutic dose of unfocused ultrasound energy are performed without determining actual locations of the renal nerves.

4. The method of claim 1, wherein the therapeutic dose of unfocused ultrasound energy is emitted in a 360°

cylindrical pattern surrounding the ultrasound transducer.

5. The method of claim 1, wherein the therapeutic dose of unfocused ultrasound energy is emitted in a pattern having a length of at least 2 mm along an axis of the renal artery.

6. The method of claim 1, wherein the therapeutic dose of unfocused ultrasound energy inactivates conduction of a length of at least 2 mm of the renal nerves.

7. The method of claim 1, further comprising positioning the ultrasound transducer out of contact with the inner wall of the renal artery at least when the balloon is inflated.

8. The method of claim 1, further comprising applying the unfocused ultrasound energy throughout the impact volume at a level insufficient to cause necrosis of tissues.

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

10. The method of claim 1, wherein actuating the ultrasound transducer to cause emission of the therapeutic dose of unfocused ultrasound energy comprises emitting the therapeutic dose of unfocused ultrasound energy from the ultrasound transducer at an acoustic power level of 10 to 30 watts for 2 seconds to a minute.

11. The method of claim 1, further comprising:

receiving ultrasound energy;

generating a signal representing the received ultrasound energy;

emitting unfocused ultrasound energy at a measurement level;

receiving an echo signal representing reflected measurement ultrasound energy; and

analyzing the received echo signal.

12. The method of claim 11, further comprising determining a size of the renal artery based on the received echo signal and varying acoustic power of the ultrasound energy used to emit the unfocused ultrasound energy depending on the determined size of the renal artery.

13. The method of claim 11, further comprising determining the therapeutic dose based on the echo signal by measuring a time delay between an actuation of the ultrasound transducer and a return of the echo signal and determining the therapeutic dose using a lookup table showing a relationship between the time delay and the therapeutic dose.

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

15. The method of claim 1, further comprising determining a volume (V) of the impact volume by:

V=π

₂²h−

π

r₁²h, where r₁ is the radius of the ultrasound transducer, r₂ is the radius of the impact volume, and h is the length of the ultrasound transducer.

16. The method of claim 1, wherein the cooled liquid delivered to the balloon comprises a radiographic contrast agent.

17. The method of claim 16, further comprising visualizing the radiographic contrast agent to verify proper placement within the renal artery using radiographic imaging.

18. The method of claim 1, further comprising repositioning the ultrasound transducer along the renal artery and re-actuating the ultrasound transducer to cause the ultrasound transducer to emit another therapeutic dose of unfocused ultrasound energy.

19. The method of claim 1, further comprising:

removing the ultrasound transducer from the renal artery;

inserting the ultrasound transducer into a second renal artery; and

re-actuating the ultrasound transducer to cause the ultrasound transducer to emit another therapeutic dose of unfocused ultrasound energy.

20. The method of claim 1, wherein the balloon has a profile and the profile of the balloon is non-circular.

21. The method of claim 1, wherein actuating the ultrasound transducer to cause emission of the therapeutic dose of unfocused ultrasound energy comprises emitting the therapeutic dose of unfocused ultrasound energy at a power level of 10 to 30 watts for 2 to 30 seconds.

22. The method of claim 1, wherein actuating the ultrasound transducer to cause emission of the therapeutic dose of unfocused ultrasound energy comprises emitting the therapeutic dose of unfocused ultrasound energy from the ultrasound transducer at a frequency of 1 to 30 MHz.