Methods for renal neuromodulation

• US 9,731,132 B2
• Filed: 09/01/2016
• Issued: 08/15/2017
• 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: Gifford, III, Hanson, Deem, Mark, Clark, Benjamin J., Zarins, Denise, Sutton, Douglas, Levin, Howard R., Gelfand, Mark
• Primary Examiner(s): BOCKELMAN, MARK
• Application Number:
  US15/254,340
• Publication Number:
  US 20170080230A1
• Time in Patent Office: 348 Days
• 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 2018/00267 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 2018/00511 Kidney
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00613 Irreversible electroporation reversible electroporation A61N1/327
• CPC Class Codes: A61B 2018/00702 Power or energy
• CPC Class Codes: A61B 2018/00779 Power or energy
• CPC Class Codes: A61B 2018/00791 Temperature
• CPC Class Codes: A61B 2018/00875 Resistance or impedance
• CPC Class Codes: A61B 2018/00982 combined with or comprising means for visual or photographic inspections inside the body, e.g. endoscopes
• CPC Class Codes: A61B 2018/1435 Spiral
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/32 alternating or intermittent currents applying electric fields by inductive or capacitive coupling A61N1/40; microwave apparatus A61N5/02
• 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 1/36117 for treating hypertension
• CPC Class Codes: A61N 1/36128 Control systems
• CPC Class Codes: A61N 5/00 : Radiation therapy ultrasound therapy A61N7/00; devices or apparatus applicable to both therapy and diagnosis A61B6/00

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 extravascular delivery of pulsed electric fields to achieve such neuromodulation.

Claims

1. A method for reducing blood pressure in a human patient, the method comprising:

implanting a neural stimulation system in the patient below the patient'"'"'s skin, wherein the neural stimulation system includes an electric field generator electrically coupled to a ring-shaped electrode positioned adjacent to target renal nerves innervating a kidney of the patient; and

delivering generated electrical signals from the electric field generator to the target nerves via the ring-shaped electrode, thereby altering the naturally occurring neural signals propagating through the nerves,

wherein delivering the generated electrical signals to the target nerves of the patient results in a therapeutically beneficial reduction in blood pressure of the patient.

2. The method of claim 1 wherein delivering generated electrical signals from the electric field generator to the target nerves via the ring-shaped electrode comprises delivering generated stimulation signals to the target nerves.

3. The method of claim 1 wherein delivering generated electrical signals from the electric field generator to the target nerves via the ring-shaped electrode comprises delivering at least two different levels of generated stimulation signals to the target nerves.

4. The method of claim 1 wherein delivering generated electrical signals from the electric field generator to the target nerves via the ring-shaped electrode comprises delivering intermittent stimulation to the target nerves.

5. The method of claim 1 wherein delivering generated electrical signals from the electric field generator to the target nerves via the ring-shaped electrode comprises delivering the electrical signals in a unipolar fashion.

6. The method of claim 1 wherein altering the naturally occurring neural signals propagating through the nerves comprises attenuating the neural signals along the target nerves.

7. The method of claim 1 wherein the ring-shaped electrode adjacent to the renal nerves at least partially surrounds a renal blood vessel of the patient.

8. The method of claim 1 wherein delivering generated electrical signals from the electric field generator to the target nerves via the ring-shaped electrode comprises decreasing renal sympathetic nerve activity of the patient.

9. The method of claim 1, further comprising monitoring at least one physiologic parameter of the patient with a sensor.

10. The method of claim 9, further comprising transmitting information regarding the monitored physiologic parameter from the sensor to a device located outside of the patient.

11. The method of claim 10 wherein the monitored physiologic parameter comprises at least one of blood pressure, renin levels, sodium levels, and renal blood flow.

12. The method of claim 10 wherein the monitored physiologic parameter is indicative of renal activity.

13. The method of claim 1 wherein the neural stimulation system further comprises an energy storage device electrically coupled to the electric field generator, and wherein the electric field generator is configured for recharging via the energy storage device.

14. The method of claim 1 wherein the neural stimulation system is configured to be reprogrammed after implantation in the patient.