Methods for extravascular renal neuromodulation

• US 10,272,246 B2
• Filed: 03/27/2018
• Issued: 04/30/2019
• 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, Zarins, Denise, Sutton, Douglas, Gifford, III, Hanson, Levin, Howard R., Gelfand, Mark, Clark, Benjamin J.
• Primary Examiner(s): Bockelman, Mark
• Application Number:
  US15/937,729
• Publication Number:
  US 20180311503A1
• Time in Patent Office: 399 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 extravascular renal neuromodulation, the method comprising:

positioning a plurality of energy delivery elements carried by a catheter at an extra-arterial location within a hypertensive human patient and adjacent to neural fibers innervating a kidney of the patient; and

ablating the neural fibers innervating the kidney via radio frequency (RF) energy from the energy delivery elements,

wherein ablating the neural fibers results in a therapeutically beneficial reduction in blood pressure of the patient.

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

3. The method of claim 2 wherein monitoring a parameter comprises monitoring power, temperature, and/or impedance.

4. The method of claim 2 wherein monitoring a parameter comprises monitoring at least one physiological parameter of the patient.

5. The method of claim 4 wherein the monitored physiological parameter comprises plasma renin levels and/or other neurohormones that are indicative of increased sympathetic nervous activity.

6. The method of claim 2, further comprising varying delivery of the RF energy in response to the monitored parameter.

7. The method of claim 1 wherein ablating the neural fibers innervating the kidney via radio frequency (RF) energy from the energy delivery elements comprises delivering RF energy in a monopolar fashion between one or more of the energy delivery elements and an external ground pad attached to an exterior of the patient.

8. The method of claim 1 wherein ablating the neural fibers innervating the kidney via radio frequency (RF) energy from the energy delivery elements comprises delivering RF energy in a bipolar fashion between two or more of the energy delivery elements.

9. The method of claim 1 wherein each of the energy delivery elements is dynamically assignable.

10. The method of claim 1 wherein positioning a plurality of energy delivery elements carried by a catheter at an extra-arterial location within the patient comprises delivering a distal segment of the catheter within a probe, and wherein the method further comprises at least partially extending the distal segment of the catheter out from the probe before delivering RF energy via the energy delivery elements.

11. The method of claim 1 wherein ablating the neural fibers innervating the kidney via RF energy from the energy delivery elements comprises ablating afferent renal nerves of the patient via the RF energy from the energy delivery elements.

12. The method of claim 1 wherein ablating the neural fibers innervating the kidney via RF energy from the energy delivery elements comprises ablating both afferent and efferent renal nerves of the patient via the RF energy from the energy delivery elements.

13. The method of claim 1 wherein positioning a plurality of energy delivery elements carried by a catheter at an extra-arterial location within the patient comprises positioning the energy delivery elements at or near a renal hilum of the patient.

14. The method of claim 1 wherein positioning a plurality of energy delivery elements carried by a catheter at an extra-arterial location within the patient comprises positioning the energy delivery elements along a renal vein of the patient.

15. The method of claim 1 wherein positioning a plurality of energy delivery elements carried by a catheter at an extra-arterial location comprises delivering the catheter over a guidewire.

16. The method of claim 1 wherein ablating the neural fibers innervating the kidney via RF energy comprises at least partially denervating the kidney of the patient.

17. The method of claim 1, further comprising removing the catheter from the patient after delivering the RF energy to conclude the procedure.

18. A method, comprising:

percutaneously introducing a plurality of electrodes at a distal region of a catheter to an extra-arterial location within a human patient and adjacent to renal nerves of the patient;

transforming the distal region of the catheter between a low-profile delivery configuration and an expanded treatment configuration; and

at least partially ablating the renal nerves via radio frequency (RF) energy from the plurality of electrodes,

wherein at least partially ablating the renal nerves significantly improves a measurable physiological parameter associated with hypertension of the patient.

19. The method of claim 18 wherein percutaneously introducing a plurality of electrodes at a distal region of a catheter to an extra-arterial location within the patient comprises positioning the plurality of electrodes under visual guidance.

20. The method of claim 18 wherein percutaneously introducing a plurality of electrodes at a distal region of a catheter to an extra-arterial location within the patient comprises positioning the plurality of electrodes under guidance chosen from the group consisting of computed tomographic, radiographic, ultrasonic, angiographic, laparoscopic and combinations thereof.

21. The method of claim 18, further comprising removing the catheter from the patient after at least partially ablating the renal nerves.