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

• US 9,943,666 B2
• Filed: 06/04/2015
• Issued: 04/17/2018
• 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:
  US14/731,347
• Publication Number:
  US 20150290427A1
• Time in Patent Office: 1,048 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 configured to be inserted into a renal artery of the mammalian subject;

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

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 into an impact volume of at least 0.5 cm³ encompassing the renal artery to inactivate conduction of renal nerves throughout the impact volume without causing damage to an intima layer of the renal artery;

a balloon mounted at the distal end of the catheter, wherein the balloon is configured to engage a wall of the renal artery without substantially blocking flow of blood through the renal artery, wherein the balloon comprises a non-circular shape when in an inflated condition and a liquid is delivered to the balloon to cool the intima layer of the renal artery; and

a machine-readable element affixed to the catheter, the machine-readable element encoding an optimum actuation frequency of ultrasonic energy to be emitted by the ultrasound transducer during use.

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

3. The apparatus of claim 2, wherein the impact volume encompasses all of the renal nerves surrounding the renal artery.

4. The apparatus of claim 1, wherein the actuator is configured to cause the ultrasound transducer to emit unfocused ultrasound energy at an acoustic power level of 10 to 30 watts for 2 to 30 seconds.

5. The apparatus of claim 1, wherein the actuator is configured to cause the transducer to maintain the temperature of the renal artery wall below 65°

C. while achieving a temperature above 42°

C. throughout the impact volume.

6. The apparatus of claim 1, wherein the ultrasound transducer is configured to emit the ultrasound energy so as to inactivate conduction of renal nerves along a length of at least 2 mm along the axis of the renal artery.

7. The apparatus of claim 1, wherein the transducer is configured to apply the ultrasonic energy at the therapeutic level throughout an impact volume having a length of at least 2 mm along the axis of the of the renal artery.

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

9. The apparatus of claim 8, wherein the catheter is constructed and arranged to hold the transducer out of contact with the wall of the renal artery.

10. The apparatus of claim 8, wherein the transducer has an axis, the catheter is constructed and arranged to hold the axis of the transducer parallel to the axis of the renal artery, and the transducer is configured to emit the ultrasound energy in a 360°

cylindrical pattern surrounding the axis of the transducer.

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

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

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

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 into an impact volume of at least 0.5 cm³ encompassing the renal artery to inactivate conduction of renal nerves throughout the impact volume without causing damage to an intima layer of the renal artery, wherein the actuator is configured to cause the ultrasound transducer to emit the unfocused ultrasound energy;

a balloon mounted at the distal end of the catheter, wherein the balloon is configured to engage a wall of the renal artery, wherein, when inflated, the balloon centers the ultrasound transducer within the renal artery and a liquid is delivered to the balloon to cool the intima layer of the renal artery; and

a machine-readable element affixed to the catheter, the machine readable element including information associated with an optimum actuation frequency.

12. The apparatus of claim 11, wherein the machine readable element is configured to be read by a reader and provide the optimum actuation frequency.

13. The apparatus of claim 11, wherein the actuator is configured to cause the ultrasound transducer to emit unfocused ultrasound energy throughout the impact volume at a level insufficient to cause necrosis of tissues.

14. The apparatus of claim 11, wherein the impact volume encompasses all of the renal nerves surrounding the renal artery.

15. The apparatus of claim 11, wherein the actuator is configured to cause the ultrasound transducer to emit unfocused ultrasound energy at an acoustic power level of 10 to 30 watts for 2 to 30 seconds.

16. The apparatus of claim 11, wherein the actuator is configured to cause the ultrasound transducer to maintain the temperature of the renal artery wall below 65°

C. while achieving a temperature above 42°

C. throughout the impact volume.

17. The apparatus of claim 11, wherein the ultrasound transducer is configured to inactivate conduction of renal nerves for a length of at least 2 mm along the axis of the renal artery.

18. The apparatus of claim 11, wherein the transducer is configured to apply the ultrasonic energy at the therapeutic level throughout an impact volume having a length of at least 2 mm along the axis of the of the renal artery.

19. The apparatus of claim 15, wherein the catheter and transducer are constructed and arranged to allow blood to flow through the renal artery while the ultrasound transducer is positioned within the renal artery.

20. The apparatus of claim 18, wherein the catheter is constructed and arranged to hold the transducer out of contact with the wall of the renal artery.

21. The apparatus of claim 18, wherein the transducer has an axis, the catheter is constructed and arranged to hold the axis of the transducer parallel to the axis of the renal artery, and the transducer is configured to emit the ultrasound energy in a 360°

cylindrical pattern surrounding the axis of the transducer.