Methods and devices to modulate the autonomic nervous system with ultrasound

• US 8,715,209 B2
• Filed: 04/12/2012
• Issued: 05/06/2014
• Est. Priority Date: 10/12/2009
• Status: Active Grant

• Current Assignee: Otsuka Medical Devices Co., Ltd. (Otsuka Holdings Company Limited)
• Original Assignee: Kona Medical, Inc.
• Inventors: Gertner, Michael
• Primary Examiner(s): Chen, Tse
• Assistant Examiner(s): REMALY, MARK DONALD
• Application Number:
  US13/445,903
• Publication Number:
  US 20120197166A1
• Time in Patent Office: 754 Days
• Field of Search: 600407-475, 601 2- 4
• US Class Current: 601/2
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 18/18 by applying electromagnetic radiation, e.g. microwaves radiation therapy A61N5/00
• 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 2034/105 Modelling of the patient, e.g. for ligaments or bones
• CPC Class Codes: A61B 2034/107 Visualisation of planned trajectories or target regions
• CPC Class Codes: A61B 2034/2051 Electromagnetic tracking systems
• CPC Class Codes: A61B 2034/2072 Reference field transducer attached to an instrument or patient
• CPC Class Codes: A61B 2034/2074 Interface software
• CPC Class Codes: A61B 2090/374 NMR or MRI
• CPC Class Codes: A61B 2090/378 using ultrasound
• CPC Class Codes: A61B 2090/3929 Active markers
• CPC Class Codes: A61B 2090/3958 emitting a signal
• CPC Class Codes: A61B 2090/3975 active
• CPC Class Codes: A61B 5/055 involving electronic [EMR] or nuclear [NMR] magnetic resonance, e.g. magnetic resonance imaging
• CPC Class Codes: A61B 6/032 Transmission computed tomography [CT]
• CPC Class Codes: A61B 6/506 for diagnosis of nerves
• CPC Class Codes: A61B 8/06 Measuring blood flow measuring volume flow in general G01F, e.g. G01F1/66, G01F1/72; measuring speed of fluids in general G01P5/00
• CPC Class Codes: A61B 8/0833 involving detecting or locating foreign bodies or organic structures
• CPC Class Codes: A61B 8/0841 : for locating instruments
• CPC Class Codes: A61B 8/0891 : for diagnosis of blood vessels
• CPC Class Codes: A61B 8/483 : involving the acquisition of a 3D volume of data
• CPC Class Codes: A61B 8/488 : involving Doppler signals
• CPC Class Codes: A61N 2007/003 : Destruction of nerve tissue
• CPC Class Codes: A61N 2007/0078 : with multiple treatment transducers
• 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 7/02 : Localised ultrasound hyperthermia hyperthermia in general A61F7/00

Abstract

In some embodiments, sympathetic nerves surrounding arteries or leading to organs are targeted with energy sources to correct or modulate physiologic processes. In some embodiments, different types of energy sources are utilized singly or combined with one another. In some embodiments, bioactive agents or devices activated by the energy sources are delivered to the region of interest and the energy is enhanced by such agents.

Claims

1. A method of treating a patient, comprising:

directing an energy applicator within a blood vessel to a target region comprising a nerve within an autonomic nervous system and delivering a three dimensional pattern of unfocused ultrasound energy to the target region in an approximately spherical or ellipsoidal configuration around a reference position associated with the blood vessel using the energy applicator, wherein the energy applicator comprises an intravascular catheter.

2. The method of claim 1, wherein the blood vessel leads to or from a kidney.

3. The method of claim 1, wherein the nerve is up to ten millimeters away from the blood vessel.

4. The method of claim 1, wherein the delivery of ultrasound energy generates heat around the blood vessel but not inside a wall of the blood vessel.

5. The method of claim 4, wherein the delivery of ultrasound energy generates a temperature around the vessel between 40 and 60 degrees Fahrenheit.

6. The method of claim 4, wherein the delivery of ultrasound energy generates a temperature around the vessel between 60 and 90 degrees Fahrenheit.

7. The method of claim 4, wherein the method further comprises cooling the inside of the blood vessel.

8. The method of claim 1, wherein the intensity of the delivered ultrasound energy is between 50 mW/cm² and 1000 mW/cm².

9. The method of claim 1, wherein the frequency of the delivered ultrasound energy is between 0.5 Mhz and 10 Mhz.

10. The method of claim 1, wherein the nerve is a renal nerve.

11. The method of claim 1, wherein the delivered three dimensional pattern of unfocused ultrasound energy at least partially modulates nerves associated with the carotid sinus.

12. The method of claim 1, wherein the delivered three dimensional pattern of unfocused ultrasound energy at least partially ablates the carotid body.

13. The method of claim 1, wherein the nerve is associated with an aortic baroreceptor.

14. A method of altering the autonomic nervous system, comprising:

delivering a three dimensional pattern of a first dose of unfocused ultrasound energy to a target region in the vicinity of a blood vessel within a patient;

detecting a change in a parameter related to a response of the autonomic nervous system to the application of the first dose;

and delivering a three dimensional pattern of a second dose of unfocused ultrasound energy to the target region in response to the detected change in the parameter,

wherein the first and second doses of unfocused ultrasound energy are delivered to the target region in an approximately spherical or ellipsoidal configuration around a reference position associated with the blood vessel.

15. The method of claim 14, wherein the parameter comprises blood pressure.

16. The method of claim 14, wherein the parameter comprises a norepinephrine level in blood.

17. The method of claim 14, wherein the parameter comprises a norepinephrine level in a kidney.

18. The method of claim 14, wherein the parameter comprises a norepinephrine level in a blood vessel leading to a kidney.

19. The method of claim 14, wherein the parameter comprises a norepinephrine level in a blood vessel leading from a kidney.

20. The method of claim 14, further comprising creating a temperature map that represents an effect of heat generated by the second dose of ultrasound energy.

21. The method of claim 14, further comprising creating a map that represents tissue elasticity.

22. The method of claim 14, further comprising delivering a bioactive agent to a region surrounding the blood vessel prior to the application of ultrasound energy.

23. The method of claim 14, wherein the target region comprises a nerve.

24. The method of claim 23, wherein the nerve comprises a renal nerve.

25. The method of claim 23, wherein the nerve is associated with an aortic baroreceptor.

26. The method of claim 14, wherein the blood vessel is a renal artery or a renal vein.

27. The method of claim 14, wherein the blood vessel is a carotid artery.

28. The method of claim 14, wherein the three dimensional pattern of first and second doses of unfocused ultrasound energy are delivered to the carotid sinus to at least partially modulate the nerves associated with the carotid sinus.

29. The method of claim 14, wherein the three dimensional pattern of first and second doses of unfocused ultrasound energy are delivered to the carotid body to at least partially ablate the carotid body.