Methods for thermally-induced renal neuromodulation

• US 8,728,138 B2
• Filed: 02/12/2013
• Issued: 05/20/2014
• 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:
  US13/765,532
• Publication Number:
  US 20130158442A1
• Time in Patent Office: 462 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 of treating a human patient diagnosed with a cardio-renal disease or disorder, the method comprising:

intravascularly delivering a device to a vicinity of a neural fiber associated with renal function of the patient; and

thermally inhibiting neural communication along the neural fiber with the device.

2. The method of claim 1 wherein thermally inhibiting neural communication along the neural fiber with the device comprises thermally inhibiting afferent neural communication along the neural fiber with the device.

3. The method of claim 1 wherein thermally inhibiting neural communication along the neural fiber with the device comprises thermally inhibiting efferent neural communication along the neural fiber with the device.

4. The method of claim 1 wherein intravascularly delivering a device to a vicinity of a neural fiber associated with renal function comprises intravascularly delivering the device via a renal blood vessel to a position proximate to the neural fiber.

5. The method of claim 1 wherein intravascularly delivering the device via a blood vessel to a position proximate to the neural fiber comprises intravascularly positioning the device in contact with a wall of the blood vessel proximate to the neural fiber.

6. The method of claim 1 wherein thermally inhibiting neural communication along the neural fiber with the device comprises at least partially ablating the neural fiber with the device.

7. The method of claim 1 wherein thermally inhibiting neural communication along the neural fiber with the device comprises thermally altering the neural fiber using at least one of non-ablative heating, ablative heating, cooling, and freezing.

8. The method of claim 1, further comprising removing the device from the patient after thermally inhibiting neural communication along the neural fiber.

9. The method of claim 1 wherein thermally inhibiting neural communication along the neural fiber with the device comprises delivering an energy field to the neural fiber via the device.

10. The method of claim 9 wherein delivering an energy field to the neural fiber via the device comprises delivering radiofrequency energy via the device.

11. The method of claim 9 wherein delivering an energy field to the neural fiber via the device comprises delivering microwave energy via the device.

12. The method of claim 9 wherein delivering an energy field to the neural fiber via the device comprises delivering ultrasound energy via the device.

13. The method of claim 12 wherein delivering ultrasound energy via the device comprises delivering high intensity focused ultrasound energy via the device.

14. The method of claim 9 wherein delivering an energy field to the neural fiber via the device comprises delivering laser energy via the device.

15. The method of claim 1 wherein thermally inhibiting neural communication along the neural fiber with the device comprises reducing neural activity via cooling the neural fiber.

16. The method of claim 1 wherein thermally inhibiting neural communication along the neural fiber with the device comprises causing freezing injury to the neural fiber.

17. The method of claim 1 wherein thermally inhibiting neural communication along the neural fiber with the device comprises delivering a thermal fluid via the device.

18. A method of treating a human patient diagnosed with a medical condition, the method comprising:

positioning a device in proximity to a neural pathway that carries nerve signals to and from a kidney of the patient; and

thermally inhibiting the nerve signals across the neural pathway with the device,

wherein thermally inhibiting the nerve signals across the neural pathway results in a therapeutically beneficial reduction in renal sympathetic nerve activity of the patient.

19. The method of claim 18 wherein treating a human patient diagnosed with a medical condition comprises treating a human patient diagnosed with hypertension.

20. The method of claim 18 wherein treating a human patient diagnosed with a medical condition comprises treating a human patient diagnosed with chronic heart failure.

21. The method of claim 18 wherein treating a human patient diagnosed with a medical condition comprises treating a human patient diagnosed with a condition associated with diabetes.

22. The method of claim 18 wherein treating a human patient diagnosed with a medical condition comprises treating a human patient diagnosed with kidney disease.

23. The method of claim 18 wherein treating a human patient diagnosed with a medical condition comprises treating a human patient diagnosed with chronic renal failure.

24. The method of claim 18 wherein treating a human patient diagnosed with a medical condition comprises treating a human patient diagnosed with acute myocardial infarction.

25. The method of claim 18 wherein treating a human patient diagnosed with a medical condition comprises treating a human patient diagnosed with atrial fibrillation.