Thermally-induced renal neuromodulation and associated systems and methods

• US 10,293,190 B2
• Filed: 10/05/2015
• Issued: 05/21/2019
• Est. Priority Date: 04/08/2002
• Status: Active Grant

• 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): Smith, Kaitlyn E
• Application Number:
  US14/875,333
• Publication Number:
  US 20160023022A1
• Time in Patent Office: 1,324 Days
• Field of Search: None
• 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, the method comprising:

intravascularly delivering a catheter to a treatment site within a renal blood vessel of a human patient and adjacent to target renal nerves of the patient;

delivering a chilled thermal fluid to the treatment site via the catheter;

thermally modulating a function of the target renal nerves via the chilled thermal fluid; and

removing the catheter from the patient after delivering the thermal fluid to conclude the therapy.

2. The method of claim 1 wherein thermally modulating the function of the target renal nerves via the chilled thermal fluid comprises delivering the chilled thermal fluid to induce non-freezing thermal slowing of nerve conduction along the target renal nerves.

3. The method of claim 1 wherein thermally modulating the function of the target renal nerves via the chilled thermal fluid comprises delivering a non-freezing thermal fluid that reduces neural signalling along the target renal nerves without causing direct neural injury to the target renal nerves.

4. The method of claim 1 wherein thermally modulating the function of the target renal nerves via the chilled thermal fluid comprises delivering a non-freezing thermal fluid that causes direct neural injury to the target renal nerves.

5. The method of claim 1 wherein delivering the chilled thermal fluid to the renal nerves comprises delivering non-freezing chilled fluid to cool the target renal nerves to a temperature between 37°

C. and 0°

C.

6. The method of claim 1 wherein delivering the chilled thermal fluid to the renal nerves comprises delivering non-freezing chilled fluid to cool the target renal nerves to a temperature between 20°

C. and 0°

C.

7. The method of claim 1 wherein delivering the chilled thermal fluid to the treatment site via the catheter comprises delivering the chilled thermal fluid continuously during therapy to thermally modulate a function of the target renal nerves.

8. The method of claim 1 wherein delivering the chilled thermal fluid to the treatment site via the catheter comprises delivering the chilled thermal fluid intermittently during therapy to thermally modulate a function of the target renal nerves.

9. The method of claim 1 wherein intravascularly delivering the catheter to a treatment site within a renal blood vessel comprises intravascularly delivering the catheter to a renal artery of the patient over a guidewire.

10. The method of claim 1 wherein thermally modulating the function of the target renal nerves via the chilled thermal fluid results in a therapeutically beneficial reduction in blood pressure of the patient.

11. The method of claim 1 wherein thermally modulating the function of the target renal nerves via the chilled thermal fluid at least partially denervates a kidney of the patient.

12. The method of claim 1, further comprising monitoring a temperature of the target renal nerves and/or non-target tissue proximate the target renal nerves during therapy.

13. The method of claim 12, further comprising altering delivery of the chilled thermal fluid in response to the monitored parameter.

14. A method for treating a hypertensive human patient, the method comprising:

transluminally positioning a catheter within a renal artery of the hypertensive patient and proximate to target neural fibers innervating a kidney of the patient;

delivering a non-freezing chilled fluid via the catheter to a treatment site adjacent the target neural fibers,

wherein the delivered non-freezing chilled fluid reduces transmission of neural signals along the neural fibers; and

removing the catheter from the patient after delivering the non-freezing chilled fluid to conclude treatment.

15. The method of claim 14 wherein delivering the non-freezing chilled fluid via the catheter and reducing transmission of neural signals along the neural fibers results in a therapeutically beneficial reduction in blood pressure of the patient.

16. The method of claim 14 wherein delivering the non-freezing chilled fluid via the catheter and reducing transmission of neural signals along the neural fibers comprises blocking neural signaling along the neural fibers.

17. The method of claim 14 wherein delivering the non-freezing chilled fluid via the catheter comprises delivering the non-freezing chilled fluid to cool the target neural fibers to a temperature between 20°

C. and 0°

C.