Methods and apparatus for renal neuromodulation

• US 8,934,978 B2
• Filed: 04/22/2014
• Issued: 01/13/2015
• 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: Deem, Mark E., Gifford, Hanson III, Zarins, Denise, Sutton, Douglas, Thai, Erik, Gelfand, Mark, Levin, Howard R.
• Primary Examiner(s): BOCKELMAN, MARK
• Application Number:
  US14/258,802
• Publication Number:
  US 20140228739A1
• Time in Patent Office: 266 Days
• Field of Search: 607/44, 607/101, 607/102, 606/33
• US Class Current: 607/44
• CPC Class Codes: A61B 18/1206 Generators therefor
• CPC Class Codes: A61B 18/1233 with circuits for assuring patient safety
• 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 18/18 by applying electromagnetic radiation, e.g. microwaves radiation therapy A61N5/00
• CPC Class Codes: A61B 2018/00071 Electrical conductivity
• CPC Class Codes: A61B 2018/00214 Expandable means emitting energy, e.g. by elements carried thereon
• CPC Class Codes: A61B 2018/0022 Balloons
• CPC Class Codes: A61B 2018/00267 having a basket shaped structure
• CPC Class Codes: A61B 2018/00404 Blood vessels other than those in or around the heart
• CPC Class Codes: A61B 2018/00434 Neural system
• CPC Class Codes: A61B 2018/00505 Urinary tract
• CPC Class Codes: A61B 2018/00511 Kidney
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00613 Irreversible electroporation
• CPC Class Codes: A61B 2018/00642 with feedback, i.e. closed loop control
• CPC Class Codes: A61B 2018/00904 Automatic detection of target tissue
• CPC Class Codes: A61B 2018/126 bipolar
• CPC Class Codes: A61B 2018/1467 using more than two electrodes on a single probe
• CPC Class Codes: A61B 8/0891 for diagnosis of blood vessels
• CPC Class Codes: A61B 8/12 in body cavities or body tracts, e.g. by using catheters catheters per se A61M25/00
• CPC Class Codes: A61M 25/0023 : by the form of the lumen, e.g. cross-section, variable diameter
• CPC Class Codes: A61M 5/14 : Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
• CPC Class Codes: A61N 1/0412 : Specially adapted for transcutaneous electroporation, e.g. including drug reservoirs
• CPC Class Codes: A61N 1/05 : for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/0551 : Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/18 : Applying electric currents by contact electrodes
• CPC Class Codes: A61N 1/205 : for promoting a biological process
• CPC Class Codes: A61N 1/326 : for promoting growth of cells, e.g. bone cells
• CPC Class Codes: A61N 1/327 : for enhancing the absorption properties of tissue, e.g. by electroporation
• CPC Class Codes: A61N 1/36007 : of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: A61N 1/36017 : with leads or electrodes penetrating the skin
• CPC Class Codes: A61N 1/36057 : adapted for stimulating afferent nerves
• CPC Class Codes: A61N 1/36103 : Neuro-rehabilitation; Repair or reorganisation of neural tissue, e.g. after stroke
• CPC Class Codes: A61N 1/36114 : Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362
• CPC Class Codes: A61N 1/36117 : for treating hypertension
• CPC Class Codes: A61N 1/36139 : with automatic adjustment
• CPC Class Codes: A61N 2007/0021 : Neural system treatment
• CPC Class Codes: A61N 2007/003 : Destruction of nerve tissue
• 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 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

Abstract

Methods and apparatus are provided for renal neuromodulation using a pulsed electric field to effectuate electroporation or electrofusion. It is expected that renal neuromodulation (e.g., denervation) may, among other things, reduce expansion of an acute myocardial infarction, reduce or prevent the onset of morphological changes that are affiliated with congestive heart failure, and/or be efficacious in the treatment of end stage renal disease. Embodiments of the present invention are configured for percutaneous intravascular delivery of pulsed electric fields to achieve such neuromodulation.

Claims

1. A method for treatment of a human patient diagnosed with hypertension, the method comprising:

positioning a distal portion of a catheter within a renal artery and proximate to a renal nerve of the patient, wherein the catheter includes—

a helical structure at the distal portion of the catheter, wherein the helical structure comprises a plurality of infusion ports or outlets, and wherein the helical structure is transformable between a low-profile delivery configuration and a deployed configuration sized and shaped to fit within the renal artery; and

a plurality of electrodes carried by the helical structure;

transforming the helical structure from the delivery configuration to the deployed configuration to place the electrodes in apposition with an inner wall of the renal artery;

inhibiting neural communication along the renal nerve via radio frequency (RF) energy from the electrodes; and

infusing a protective agent from the plurality of infusion ports or outlets into the renal artery before, during, and/or after delivery of RF energy from the electrodes.

2. The method of claim 1 wherein positioning a distal portion of a catheter within a renal artery comprises delivering the catheter over a guidewire.

3. The method of claim 1, further comprising monitoring a parameter of the catheter and/or tissue within the patient before and during delivery of RF energy.

4. The method of claim 3 wherein the electrodes are dynamically assignable, and wherein the method further comprises altering delivery of RF energy to one or more of the electrodes in response to the monitored parameter.

5. The method of claim 1 wherein the electrodes are configured for monopolar RF energy delivery.

6. The method of claim 1 wherein the helical structure comprises five ring electrodes arranged thereon, and wherein each electrode is dynamically assignable.

7. The method of claim 1 wherein infusing a protective agent from the plurality of infusion ports or outlets into the renal artery comprises infusing a chilled fluid, saline, hypertonic saline, or heparinized saline, and/or an anti-proliferative agent.

8. The method of claim 1 wherein inhibiting neural communication along the renal nerve via RF energy comprises ablating the renal nerve of the patient.

9. The method of claim 1 wherein inhibiting neural communication along the renal nerve via RF energy comprises partially ablating the renal nerve of the patient.

10. The method of claim 1 wherein inhibiting neural communication along the renal nerve via RF energy comprises at least partially blocking afferent and efferent neural traffic to and/or from a kidney of the patient.