Methods for renal neuromodulation

• US 9,186,213 B2
• Filed: 05/15/2014
• 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: Deem, Mark, Zarins, Denise, Sutton, Douglas, Gifford, Hanson III, Levin, Howard R., Gelfand, Mark, Clark, Benjamin J.
• Primary Examiner(s): BOCKELMAN, MARK
• Application Number:
  US14/279,023
• Publication Number:
  US 20140336638A1
• Time in Patent Office: 551 Days
• Field of Search: 607/2, 607/40, 607/44, 607/116, 607/118
• US Class Current: 1/1
• 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 treatment of a human patient diagnosed with hypertension, the method comprising:

extravascularly positioning a device having an energy delivery element in a vicinity of a renal nerve of the patient; and

delivering an energy field reduces neural signaling to or from the kidney and via the energy delivery element to modulate a function of the renal nerve,

wherein delivering the energy field results in a therapeutically beneficial reduction in blood pressure of the patient.

2. The method of claim 1 wherein extravascularly positioning a device having an energy delivery element in a vicinity of a renal nerve comprises positioning the device near a renal hilum of the patient.

3. The method of claim 1 wherein extravascularly positioning a device having an energy delivery element in a vicinity of a renal nerve comprises inserting the device in proximity to the renal nerve and along a renal blood vessel of the patient.

4. The method of claim 1 wherein extravascularly positioning a device having an energy delivery element in a vicinity of a renal nerve comprises delivering the device over a guidewire.

5. The method of claim 1 wherein extravascularly positioning a device having an energy delivery element in a vicinity of a renal nerve comprises delivering the device within an introducer, and wherein the method further comprises at least partially withdrawing the introducer before delivering the energy field.

6. The method of claim 1 wherein the device comprises an expandable member transformable between a collapsed configuration and a deployed configuration, and wherein:

extravascularly positioning the device comprises delivering the expandable member to the vicinity of the renal nerve in the collapsed configuration, and

wherein the method further comprises transforming the expandable member to the deployed configuration before delivering the energy field.

7. The method of claim 6 wherein the expandable member comprises a basket, and wherein the energy delivery element comprises a group of electrodes carried by the basket.

8. The method of claim 1 wherein:

extravascularly positioning a device having an energy delivery element in a vicinity of a renal nerve comprises positioning a device having a group of electrodes; and

delivering an energy field via the energy delivery element comprises delivering radio frequency (RF) energy to the renal nerves via the group of electrodes.

9. The method of claim 8 wherein delivering RF energy to the renal nerves via the group of electrodes comprises delivering RF energy in a monopolar fashion between one or more electrodes of the group of electrodes and an external ground pad attached to an exterior of the patient.

10. The method of claim 1, further comprising monitoring a parameter of the device and/or tissue within the patient before and during delivery of the energy field.

11. The method of claim 10 wherein monitoring a parameter comprises monitoring power, temperature, and/or impedance.

12. The method of claim 10, further comprising altering delivery of the energy field in response to the monitored parameter.

13. The method of claim 10 wherein monitoring a parameter comprises monitoring temperature of the tissue, and wherein the method further comprises maintaining the tissue at a desired temperature during delivery of the energy field.

14. The method of claim 1 wherein delivering an energy field via the energy delivery element comprises thermally altering the renal nerve in a manner that reduces neural signaling to and from a kidney of the patient.

15. The method of claim 1 wherein delivering an energy field via the energy delivery element comprises denervating the renal nerve of the patient.

16. The method of claim 1 wherein delivering an energy field via the energy delivery element comprises at least partially ablating the renal nerve of the patient.

17. The method of claim 1 wherein delivering an energy field via the energy delivery element comprises at least partially blocking afferent and efferent neural signaling to and/or from a kidney of the patient.

18. A method for renal neuromodulation, the method comprising:

positioning a distal basket of a catheter at an extravascular location within a human patient and adjacent to neural fibers innervating a kidney of the patient;

transforming the distal basket from a low-profile delivery configuration to an expanded treatment configuration,

wherein, in the treatment configuration, the basket is sized and shaped to place a plurality of electrodes arranged thereabout in apposition with target tissue at or near the neural fibers; and

blocking the neural fibers innervating the kidney via radio frequency (RF) energy from the electrodes.

19. The method of claim 18 wherein blocking the neural fibers innervating the kidney comprises blocking at least one of an efferent nerve and an afferent nerve via RF energy from the electrodes.

20. The method of claim 18 wherein blocking the neural fibers innervating the kidney comprises at least partially denervating the kidney.

21. The method of claim 18, further comprising removing the catheter from the patient after blocking the nerves.

22. The method of claim 18 wherein positioning a distal basket of a catheter at an extravascular location comprises positioning the distal basket at a renal hilum of the patient.

23. The method of claim 18 wherein positioning a distal basket of a catheter at an extravascular location comprises delivering the catheter to the extravascular location over a guidewire.

24. The method of claim 18 wherein:

positioning a distal basket of a catheter at an extravascular location comprises constraining the basket in the delivery configuration within a probe; and

transforming the distal basket from the delivery configuration to the treatment configuration comprises extending the basket and/or retracting the probe relative to the basket to transform the basket to the treatment configuration.

25. The method of claim 18 wherein positioning a distal basket of a catheter at an extravascular location comprises positioning the distal basket under guidance chosen from the group consisting of visual, computed tomographic, radiographic, ultrasonic, angiographic, laparoscopic and combinations thereof.