Ultrasound apparatuses for thermally-induced renal neuromodulation and associated systems and methods

• US 9,186,198 B2
• Filed: 09/14/2012
• Issued: 11/17/2015
• Est. Priority Date: 04/08/2002
• Status: Expired due to Fees

• Current Assignee: Medtronic Ardian Luxembourg SARL (Medtronic Plc)
• Original Assignee: Medtronic Ardian Luxembourg SARL (Medtronic Plc)
• Inventors: Demarais, Denise, Zadno, Nicolas, Clark, Benjamin J., Thai, Erik, Levin, Howard R., Gelfand, Mark
• Primary Examiner(s): Smith, Kaitlyn
• Application Number:
  US13/620,043
• Publication Number:
  US 20130012844A1
• Time in Patent Office: 1,159 Days
• Field of Search: 601/30, 601/3, 606/27
• US Class Current: 1/1
• 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 catheter-based renal neuromodulation, the method comprising:

positioning a catheter having a therapeutic element within a renal blood vessel of a human patient and proximate to neural fibers associated with renal function, wherein the therapeutic element comprises one or more ultrasound transducers positioned along the catheter; and

thermally inhibiting neural activity along the neural fibers via ultrasound energy from the therapeutic element.

2. The method of claim 1, wherein positioning the catheter having the therapeutic element within the renal blood vessel comprises intravascularly positioning the catheter having the one or more ultrasound transducers within a renal artery of the patient.

3. The method of claim 1, wherein thermally inhibiting neural activity along the neural fibers comprises delivering ultrasound energy via the one or more ultrasound transducers to a renal nerve proximate to a renal artery of the patient.

4. The method of claim 3, wherein transferring ultrasound energy via the one or more ultrasound transducers to the renal nerve of the patient comprises transmitting the ultrasound waves over a full 360°

about the catheter.

5. The method of claim 1, wherein thermally inhibiting neural activity along the neural fibers comprises blocking neural traffic to and/or from a kidney of the patient.

6. The method of claim 1, wherein thermally inhibiting neural activity along the neural fibers comprises ablating a renal nerve of the patient via ultrasound energy from the one or more ultrasound transducers.

7. The method of claim 1, wherein the catheter comprises an inflatable balloon proximate to the one or more ultrasound transducers, and wherein positioning the catheter having the therapeutic element within the renal blood vessel comprises intravascularly delivering the inflatable balloon to the renal blood vessel in a reduced delivery and retrieval configuration and expanding the balloon to a deployed configuration within the renal blood vessel.

8. The method of claim 1, wherein thermally inhibiting neural activity along the neural fibers comprises ablating the neural fibers.

9. The method of claim 1, wherein thermally inhibiting neural activity along the neural fibers alleviates clinical symptoms of hypertension in the patient.

10. The method of claim 1, wherein thermally inhibiting neural activity along the neural fibers alleviates clinical symptoms of atrial fibrillation in the patient.

11. The method of claim 1, wherein thermally inhibiting neural activity along the neural fibers alleviates clinical symptoms of renal disease in the patient.

12. The method of claim 1, wherein thermally inhibiting neural activity along the neural fibers alleviates clinical symptoms of Congestive Heart Failure in the patient.