Methods and apparatus for renal neuromodulation

• US 9,956,410 B2
• Filed: 06/28/2017
• Issued: 05/01/2018
• 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, III, Hanson, Levin, Howard R., Gelfand, Mark, Clark, Benjamin J.
• Primary Examiner(s): BOCKELMAN, MARK
• Application Number:
  US15/636,381
• Publication Number:
  US 20170361100A1
• Time in Patent Office: 307 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
• 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, comprising:

extravascularly delivering a plurality of energy delivery elements at a distal segment of a treatment device proximate to renal nerves of a hypertensive human patient; and

delivering electrical energy via the energy delivery elements to attenuate neural traffic along the renal nerves innervating the kidney,

wherein delivering electrical energy via the energy delivery elements results in a therapeutically beneficial reduction in blood pressure of the patient.

2. The method of claim 1 wherein extravascularly delivering a plurality of energy delivery elements at a distal segment of a treatment device proximate to renal nerves comprises delivering the distal segment of the device within an introducer, and wherein the method further comprises at least partially withdrawing the introducer before delivering electrical energy via the energy delivery elements.

3. The method of claim 1 wherein the distal segment of the treatment device comprises a pre-formed spiral shape transformable between (a) a low profile delivery configuration and (b) an expanded configuration that tends to assume the spiral shape and positions the energy delivery elements in contact with tissue at or near the renal nerves before delivering electrical energy via the energy delivery elements.

4. The method of claim 1 wherein extravascularly delivering a plurality of energy delivery elements at a distal segment of a treatment device proximate to renal nerves comprises inserting the distal segment in proximity to the renal nerves and along a renal blood vessel of the patient.

5. The method of claim 1 wherein extravascularly delivering a plurality of energy delivery elements at a distal segment of a treatment device proximate to renal nerves comprises delivering the treatment device over a guidewire.

6. The method of claim 1 wherein delivering electrical energy via the energy delivery elements comprises delivering radio frequency (RF) energy to the renal nerves via the plurality of energy delivery elements.

7. The method of claim 6 wherein delivering radio frequency (RF) energy to the renal nerves via the plurality of 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, further comprising monitoring a parameter of the treatment device and/or tissue within the patient before and during delivery of electrical energy via the energy delivery elements.

9. The method of claim 8 wherein monitoring a parameter comprises monitoring power, temperature, and/or impedance.

10. The method of claim 9, further comprising altering delivery of the electrical energy in response to the monitored parameter.

11. The method of claim 1 wherein delivering electrical energy via the energy delivery elements to attenuate neural traffic along the renal nerves comprises ablating renal nerves of the patient.

12. The method of claim 1 wherein delivering electrical energy via the energy delivery elements to attenuate neural traffic along the renal nerves comprises partially ablating renal nerves of the patient.

13. The method of claim 1 wherein delivering electrical energy via the energy delivery elements to attenuate neural traffic along the renal nerves reduces neural signaling to and from a kidney of the patient.

14. The method of claim 1 wherein attenuating neural traffic along the renal nerves comprises at least partially denervating a kidney of the patient.

15. The method of claim 1, further comprising removing the treatment device from the patient after delivering the electrical energy to conclude the procedure.

16. A method for treating a hypertensive human patient, the method comprising:

positioning a plurality of electrodes at a distal region 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 region of the catheter from a low-profile delivery state to an expanded treatment state,

wherein, in the treatment state, the distal region of the catheter is sized and shaped to place the plurality of electrodes in contact 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.

17. The method of claim 16 wherein ablating the neural fibers innervating the kidney significantly improves a measurable physiological parameter associated with the hypertension of the patient.

18. The method of claim 16 wherein ablating the neural fibers innervating the kidney results in a therapeutically beneficial reduction in blood pressure of the patient.

19. The method of claim 16 wherein ablating the neural fibers innervating the kidney comprises at least partially denervating the kidney of the patient.

20. The method of claim 16 wherein positioning a plurality of electrodes at a distal region of a catheter at an extravascular location comprises positioning the plurality of electrodes under visual guidance.

21. The method of claim 16 wherein positioning a plurality of electrodes at a distal region of a catheter at an extravascular location comprises positioning the plurality of electrodes under guidance chosen from the group consisting of computed tomographic, radiographic, ultrasonic, angiographic, laparoscopic and combinations thereof.