Methods for renal neuromodulation

• US 9,463,066 B2
• Filed: 10/08/2015
• Issued: 10/11/2016
• 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, Hanson III, Levin, Howard R., Gelfand, Mark, Clark, Benjamin J.
• Primary Examiner(s): BOCKELMAN, MARK
• Application Number:
  US14/878,898
• Publication Number:
  US 20160100883A1
• Time in Patent Office: 369 Days
• 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
• 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 renal neuromodulation, the method comprising:

positioning a spiral element of a catheter at an extra-arterial location within a human patient and adjacent to neural fibers innervating a kidney of the patient;

transforming the spiral element from a low-profile delivery configuration to an expanded treatment configuration,

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

ablating the neural fibers innervating the kidney via radio frequency (RF) energy from the electrodes, wherein ablating the neural fibers innervating the kidney results in a therapeutically beneficial reduction in blood pressure in the patient.

2. The method of claim 1 wherein positioning a spiral element of a catheter at an extra-arterial location comprises positioning the spiral element at a renal hilum of the patient.

3. The method of claim 1 wherein positioning a spiral element of a catheter at an extra-arterial location comprises positioning the spiral element adjacent a renal hilum of the patient.

4. The method of claim 1 wherein positioning a spiral element of a catheter at an extra-arterial location comprises delivering the catheter to the extra-arterial location over a guidewire.

5. The method of claim 1 wherein ablating the neural fibers innervating the kidney comprises ablating at least one of an efferent nerve and an afferent nerve via RF energy from the electrodes.

6. The method of claim 1 wherein ablating the neural fibers innervating the kidney comprises at least partially denervating the kidney.

7. The method of claim 1 wherein ablating the neural fibers innervating the kidney via RF energy comprises delivering the RF energy in a monopolar fashion between one or more of the electrodes and an external ground pad attached to the patient.

8. The method of claim 1 wherein ablating the neural fibers innervating the kidney via RF energy comprises delivering the RF energy in a bipolar fashion.

9. The method of claim 1, further comprising removing the catheter from the patient after ablating the neural fibers.

10. A method for treatment of a hypertensive human patient, the method comprising:

extravascularly positioning a pre-shaped distal segment of a treatment device proximate renal nerves of the patient, wherein the pre-shaped distal segment comprises a plurality of energy delivery elements; and

delivering an energy field via the energy delivery elements to disrupt neural traffic along the renal nerves wherein disrupting the neural traffic along the renal nerves reduces neural signaling to and from a kidney of the patient,

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

11. The method of claim 10 wherein extravascularly positioning a pre-shaped distal segment of a treatment device proximate renal nerves comprises positioning the pre-shaped distal segment at or near a renal hilum of the patient.

12. The method of claim 10 wherein extravascularly positioning a pre-shaped distal segment of a treatment device proximate renal nerves comprises inserting the pre-shaped distal segment in proximity to the renal nerves and along a renal blood vessel of the patient.

13. The method of claim 10 wherein extravascularly positioning a pre-shaped distal segment of a treatment device proximate renal nerves comprises delivering the treatment device over a guidewire.

14. The method of claim 10 wherein extravascularly positioning a pre-shaped distal segment of a treatment device proximate renal nerves comprises delivering the pre-shaped distal segment within an introducer, and wherein the method further comprises at least partially withdrawing the introducer before delivering the energy field.

15. The method of claim 10 wherein the pre-shaped distal segment comprises a helical shape, and wherein the pre-shaped distal segment is transformable between (a) a low profile delivery configuration and (b) an expanded configuration that tends to assume the helical shape and positions the energy delivery elements in contact with tissue at or near the renal nerves before delivering the energy field.

16. The method of claim 10 wherein delivering an energy field via the energy delivery elements comprises delivering radio frequency (RF) energy to the renal nerves via the energy delivery elements.

17. The method of claim 16 wherein delivering RF energy to the renal nerves via 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.

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

19. The method of claim 18 wherein monitoring a parameter comprises monitoring power, temperature, and/or impedance.

20. The method of claim 18, further comprising altering delivery of the energy field in response to the monitored parameter.

21. The method of claim 10 delivering an energy field via the energy delivery elements comprises ablating renal nerves of the patient.

22. The method of claim 10 wherein delivering an energy field via the energy delivery elements comprises partially ablating renal nerves of the patient.

23. The method of claim 10, further comprising removing the treatment device from the patient after delivering the energy field to conclude the procedure.