Methods for thermally-induced renal neuromodulation

• US 8,784,463 B2
• Filed: 02/12/2013
• Issued: 07/22/2014
• Est. Priority Date: 04/08/2002
• Status: Expired due to Term

• Current Assignee: Medtronic Ardian Luxembourg SARL (Medtronic Plc)
• Original Assignee: Medtronic Ardian Luxembourg SARL (Medtronic Plc)
• Inventors: Zarins, Denise, Zadno, Nicolas, Clark, Benjamin J., Thai, Erik, Levin, Howard R., Gelfand, Mark
• Primary Examiner(s): Dvorak, Linda
• Assistant Examiner(s): SMITH, KAITLYN ELIZABETH
• Application Number:
  US13/765,487
• Publication Number:
  US 20130158441A1
• Time in Patent Office: 525 Days
• Field of Search: 607/89, 607/96, 607/116
• US Class Current: 607/96
• CPC Class Codes: A61B 18/02 by cooling, e.g. cryogenic techniques devices for cooling specific reflex points of the body within cell-life limits A61H39/06
• CPC Class Codes: A61B 18/04 by heating by applying electromagnetic radiation A61B18/18; hyperthermia using electric or magnetic fields, radiation or ultrasound A61N
• CPC Class Codes: A61B 18/12 by passing a current through the tissue to be heated, e.g. high-frequency current
• 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 2018/0022 Balloons
• CPC Class Codes: A61B 2018/00434 Neural system
• CPC Class Codes: A61B 2018/00511 Kidney
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61F 2007/126 for invasive application, e.g. for introducing into blood vessels
• CPC Class Codes: A61F 7/007 characterised by electric heating
• CPC Class Codes: A61F 7/12 Devices for heating or cooling internal body cavities
• CPC Class Codes: A61F 7/123 using a flexible balloon containing the thermal element
• CPC Class Codes: A61M 2210/1082 Kidney
• CPC Class Codes: A61M 5/44 having means for cooling or heating the devices or media
• CPC Class Codes: A61N 1/28 Apparatus for applying thermoelectric currents
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: A61N 1/403 for thermotherapy, e.g. hyperthermia
• CPC Class Codes: A61N 2007/003 Destruction of nerve tissue
• CPC Class Codes: A61N 2007/0078 with multiple treatment transducers
• CPC Class Codes: A61N 5/00 Radiation therapy ultrasound therapy A61N7/00; devices or apparatus applicable to both therapy and diagnosis A61B6/00
• CPC Class Codes: A61N 5/025 : Warming the body, e.g. hyperthermia treatment
• CPC Class Codes: A61N 5/045 : specially adapted for treatment inside the body
• CPC Class Codes: A61N 5/0603 : for treatment of body cavities
• 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
• CPC Class Codes: A61N 7/022 : intracavitary

Abstract

Methods and apparatus are provided for thermally-induced renal neuromodulation. Thermally-induced renal neuromodulation may be achieved via direct and/or via indirect application of thermal energy to heat or cool neural fibers that contribute to renal function, or of vascular structures that feed or perfuse the neural fibers. In some embodiments, parameters of the neural fibers, of non-target tissue, or of the thermal energy delivery element, may be monitored via one or more sensors for controlling the thermally-induced neuromodulation. In some embodiments, protective elements may be provided to reduce a degree of thermal damage induced in the non-target tissues.

Claims

1. A method for thermally-induced renal neuromodulation of a human patient, the method comprising:

delivering a renal neuromodulation device to a vicinity of a neural fiber that contributes to renal function of the patient; and

thermally inducing modulation of a function of the neural fiber with the renal neuromodulation device such that the neural fiber is thermally altered.

2. The method of claim 1 wherein thermally inducing modulation of a function of the neural fiber further comprises directly applying thermal energy to the neural fiber.

3. The method of claim 1 wherein thermally inducing modulation of a function of the neural fiber further comprises indirectly applying thermal energy to the neural fiber.

4. The method of claim 1 wherein thermally inducing modulation of a function of the neural fiber further comprises delivering a thermal electric field to the neural fiber via at least one electrode.

5. The method of claim 4 wherein:

delivering a renal neuromodulation device to a vicinity of the neural fiber further comprises intravascularly delivering the renal neuromodulation device; and

delivering a thermal electric field to the neural fiber via at least one electrode further comprises delivering the thermal electric field via at least one wall-contacting electrode.

6. The method of claim 1, further comprising monitoring a parameter of (a) the neural fiber, (b) non-target tissue, and/or (c) the renal neuromodulation device during thermally-induced modulation of the function of the neural fiber.

7. The method of claim 6, further comprising controlling the thermally-induced modulation in response to the monitored parameter.

8. The method of claim 1, further comprising actively protecting non-target tissue during thermally-induced modulation of the function of the neural fiber.

9. The method of claim 8 wherein actively protecting the non-target tissue further comprises reducing a degree of thermal damage induced in the non-target tissue.

10. The method of claim 1 wherein thermally inducing modulation of a function of the neural fiber further comprises delivering a thermal fluid to a vicinity of the neural fiber.

11. The method of claim 1 wherein thermally inducing modulation of a function of the neural fiber further comprises exchanging heat with the neural fiber via a thermoelectric element.

12. The method of claim 1 wherein thermally inducing modulation of a function of the neural fiber further comprises delivering ultrasound to the neural fiber.

13. The method of claim 1 wherein thermally inducing modulation of a function of the neural fiber further comprises delivering high intensity focused ultrasound to the neural fiber.

14. The method of claim 1 wherein thermally inducing modulation of the function of the neural fiber further comprises heating the neural fiber.

15. The method of claim 1 wherein thermally inducing modulation of the function of the neural fiber further comprises cooling the neural fiber.

16. The method of claim 1 wherein thermally inducing modulation of a function of the neural fiber therapeutically treats a diagnosed condition or disease associated with cardio-renal function of the patient.

17. The method of claim 1 wherein thermally inducing modulation of a function of the neural fiber results in a therapeutically beneficial reduction in blood pressure of the patient.

18. The method of claim 1, further comprising removing the renal neuromodulation device from the patient after thermally inducing modulation of the neural fiber.

19. A method for thermally-induced renal neuromodulation of a human patient, the method comprising:

delivering a device proximate to a neural fiber that contributes to renal function of the patient; and

thermally inducing modulation of a function of the neural fiber with the device,

wherein thermally inducing modulation of a function of the neural fiber results in a therapeutically beneficial reduction in blood pressure of the patient.

20. The method of claim 19 wherein thermally inducing modulation of a function of the neural fiber comprises blocking neural traffic to and/or from a kidney of the patient.

21. The method of claim 19 wherein thermally inducing modulation of a function of the neural fiber comprises ablating the neural fiber.

22. The method of claim 19 wherein thermally inducing modulation of a function of the neural fiber comprises cooling the neural fiber.

23. The method of claim 19 wherein thermally inducing modulation of a function of the neural fiber comprises at least partially denervating a kidney of the patient.

24. The method of claim 19, further comprising removing the device from the patient after thermally inducing modulation of the neural fiber.