Method and Apparatus for Treatment of Hypertension Through Percutaneous Ultrasound Renal Denervation

• US 20140031727A1
• Filed: 03/14/2013
• Published: 01/30/2014
• Est. Priority Date: 10/30/2009
• Status: Active Grant

• Current Assignee: Recor Medical, Inc. (Otsuka Holdings Company Limited)
• Original Assignee: Sound Interventions Inc.
• Inventors: Warnking, Reinhard J.
• Granted Patent: US 10,039,901 B2
• Time in Patent Office: Days
• US Class Current: 601/3
• 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

1-15. -15. (canceled)

16. A method for inactivating renal nerve conduction in a mammalian subject comprising the steps of:

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 at the distal end of the catheter;

inflating the balloon, wherein the balloon comprises a non-circular shape when in an inflated condition such that a first outer diameter of the balloon is greater than a second outer diameter of the balloon, wherein the balloon is formed from a porous membrane;

delivering cooled liquid to the balloon, wherein cooled liquid delivered to the balloon is ejected into a blood stream of the mammalian subject through the porous membrane to cool an inner lining of the renal artery; and

actuating using an actuator, based on an optimum actuation frequency of ultrasonic energy encoded on a machine-readable element affixed to the catheter, the transducer to transmit a predetermined therapeutically effective dose of unfocused ultrasound energy into an impact volume of at least 0.5 cm³, encompassing the renal artery so that the therapeutically effective dose of unfocused ultrasound energy inactivates conduction of all the renal nerves in the impact volume, wherein the actuator is adapted to control the ultrasound transducer to transmit ultrasound energy in a pulsed function.

18. The method of claim 16, wherein the step of transmitting ultrasound energy is performed so as to maintain the temperature of the renal artery wall below 65°

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

C.

19. The method of claim 16, wherein the steps of inserting the ultrasound transducer and actuating the transducer to transmit ultrasound energy are performed without determining the actual locations of renal nerves.

25. The method of claim 16, wherein the therapeutically effective unfocused ultrasound energy is transmitted in a 360°

cylindrical pattern surrounding the transducer.

26. The method of claim 16, wherein the therapeutically effective unfocused ultrasound energy is transmitted in a pattern having a length of at least approximately 2 mm along the axis of the renal artery.

27. The method of claim 16, wherein the therapeutically effective unfocused ultrasound energy inactivates conduction of a length of at least approximately 2 mm of the renal nerves.

17. (canceled)

20-24. -24. (canceled)

28-38. -38. (canceled)