Methods for thermally-induced renal neuromodulation

• US 8,728,137 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:
  US13/765,510
• Publication Number:
  US 20130165822A1
• Time in Patent Office: 462 Days
• Field of Search: 607/89, 607/96
• 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 neuromodulation of a human patient, the method comprising:

intravascularly delivering a 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 device.

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

3. The method of claim 1 wherein intravascularly delivering a device to a vicinity of a neural fiber that contributes to renal function comprises:

intravascularly delivering the device in a low profile delivery configuration to a position within a renal blood vessel of the patient and proximate the neural fiber; and

transforming the device from the delivery configuration to a deployed configuration within the renal blood vessel before thermally inducing modulation.

4. The method of claim 3, further comprising:

transforming the device from the deployed configuration to the low profile configuration after thermally inducing modulation of a function of the neural fiber; and

removing the device from the patient.

5. The method of claim 3 wherein the device comprises an expandable wire basket carrying multiple electrodes, and wherein transforming the device from the delivery configuration to a deployed configuration comprises positioning the electrodes in contact with a wall of the renal blood vessel proximate to the neural fiber.

6. The method of claim 1 wherein intravascularly delivering a device to a vicinity of a neural fiber that contributes to renal function comprises delivering the device to renal vasculature of the patient via a guidewire.

7. The method of claim 1 wherein thermally inducing modulation of a function of the neural fiber comprises ablating the neural fiber.

8. The method of claim 1 wherein thermally inducing modulation of a function of the neural fiber comprises at least partially denervating a kidney of the patient.

9. The method of claim 1 wherein thermally inducing modulation of a function of the neural fiber comprises thermally modulating afferent and efferent renal nerves via the device.

10. The method of claim 1 wherein:

intravascularly delivering a device to a vicinity of a neural fiber of the patient comprises intravascularly delivering the device in a patient diagnosed with chronic heart failure, hypertension, chronic renal failure, end-stage renal disease, myocardial infarction, and/or atrial fibrillation; and

thermally inducing modulation of a function of the neural fiber with the device alleviates clinical symptoms of the diagnosed disease of the patient.

11. 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.

12. The method of claim 11 wherein 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.

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

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

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

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

17. A method, comprising:

intravascularly delivering a renal denervation catheter in a reduced profile delivery configuration to a vicinity of a neural pathway that contributes to renal function of a human patient, wherein the renal denervation catheter comprises a basket having a plurality of electrodes arranged thereabout;

transforming the renal denervation catheter from the reduced profile delivery configuration to a deployed configuration with the electrodes in contact with an inner wall of a renal blood vessel of the patient, and wherein, in the deployed configuration, the basket is configured to allow blood to flow therethrough; and

thermally altering the neural pathway via energy from the electrodes such that neural communication along the neural pathway is inhibited.

18. The method of claim 17 wherein intravascularly delivering a renal denervation catheter comprises delivering the catheter over a guidewire.

19. The method of claim 17 wherein thermally altering the neural pathway via energy from the electrodes comprises delivering radiofrequency energy via the electrodes.

20. The method of claim 17, further comprising removing the device from the patient after thermally altering the neural pathway.

21. The method of claim 17 wherein thermally altering the neural pathway via energy from the electrodes results in a therapeutically beneficial reduction in blood pressure of the patient.

22. The method of claim 17 wherein thermally altering the neural pathway via energy from the electrodes such that neural communication along the neural pathway is inhibited comprises blocking neural traffic to and/or from a kidney of the patient.

23. The method of claim 17 wherein thermally altering the neural pathway via energy from the electrodes comprises ablating target neural fibers of the neural pathway.

24. The method of claim 17 wherein thermally altering the neural pathway via energy from the electrodes comprises at least partially denervating a kidney of the patient.