Methods for monopolar renal neuromodulation

• US 9,468,497 B2
• Filed: 03/14/2016
• Issued: 10/18/2016
• 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: Zarins, Denise, Gifford, Hanson III, Deem, Mark, Levin, Howard R., Gelfand, Mark, Zadno, Nicolas
• Primary Examiner(s): BOCKELMAN, MARK
• Application Number:
  US15/069,868
• Publication Number:
  US 20160184012A1
• Time in Patent Office: 218 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 18/1482 having a long rigid shaft for accessing the inner body transcutaneously in minimal invasive surgery, e.g. laparoscopy
• 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 18/16 Indifferent or passive electrodes for grounding
• CPC Class Codes: A61B 2017/00154 pulsed
• CPC Class Codes: A61B 2018/00214 Expandable means emitting energy, e.g. by elements carried thereon
• CPC Class Codes: A61B 2018/0022 Balloons
• CPC Class Codes: A61B 2018/00261 arranged in a line
• CPC Class Codes: A61B 2018/00267 having a basket shaped structure
• CPC Class Codes: A61B 2018/00279 deployable
• 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 2018/00642 with feedback, i.e. closed loop control
• CPC Class Codes: A61B 2018/00875 Resistance or impedance
• CPC Class Codes: A61B 2018/124 switching the output to different electrodes, e.g. sequentially
• CPC Class Codes: A61B 2018/1253 monopolar
• CPC Class Codes: A61B 2018/1435 Spiral
• CPC Class Codes: A61B 2018/1467 using more than two electrodes on a single probe
• CPC Class Codes: A61B 2018/1472 : for use with liquid electrolyte, e.g. virtual electrodes
• CPC Class Codes: A61B 5/0536 : Impedance imaging, e.g. by tomography
• CPC Class Codes: A61B 5/201 : Assessing renal or kidney functions
• CPC Class Codes: A61B 5/4848 : Monitoring or testing the effects of treatment, e.g. of medication
• CPC Class Codes: A61N 1/0551 : Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/327 : for enhancing the absorption properties of tissue, e.g. by electroporation
• CPC Class Codes: A61N 1/36017 : with leads or electrodes penetrating the skin

Abstract

Methods and apparatus are provided for monopolar neuromodulation, e.g., via a pulsed electric field. Such monopolar neuromodulation may effectuate irreversible electroporation or electrofusion, necrosis and/or inducement of apoptosis, alteration of gene expression, action potential attenuation or blockade, changes in cytokine up-regulation and other conditions in target neural fibers. In some embodiments, monopolar neuromodulation is applied to neural fibers that contribute to renal function. In some embodiments, such monopolar neuromodulation is performed bilaterally.

Claims

1. A method for treating hypertension in a human patient via renal denervation, the method comprising:

intravascularly placing a monopolar electrode at least substantially proximate to a post-ganglionic nerve that innervates a kidney of a patient;

electrically coupling a ground electrode to an exterior of the patient; and

delivering an electric field between the monopolar electrode and the ground electrode such that the resulting electric field attenuates neural communication along the post-ganglionic nerve,

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

2. The method of claim 1 wherein intravascularly placing a monopolar electrode at least substantially proximate to a post-ganglionic nerve comprises intravascularly placing the monopolar electrode within a renal artery via a femoral artery and an aorta of the patient.

3. The method of claim 1, further comprising removing the electrode from the patient after delivering the electric field.

4. The method of claim 1 wherein attenuating neural communication along the post-ganglionic nerve comprises ablating the nerve.

5. The method of claim 1 wherein attenuating neural communication along the post-ganglionic nerve comprises partially ablating the nerve.

6. The method of claim 1 wherein attenuating neural communication along the post-ganglionic nerve comprises blocking neural traffic to and/or from the kidney.

7. The method of claim 1 wherein the monopolar electrode is carried by an expandable basket, and wherein intravascularly placing a monopolar electrode at least substantially proximate to a post-ganglionic nerve comprises intravascularly delivering the expandable basket to a renal artery of the patient in a low-profile configuration and transforming the basket to a deployed configuration to place the electrode in contact with a wall of the renal artery.

8. The method of claim 1, further comprising monitoring a parameter of tissue within the patient before and during delivery of the electric field.

9. The method of claim 8, further comprising modifying delivery of the electric field in response to the monitored parameter.

10. A method for at least partially denervating a kidney of a human patient, the method comprising:

transluminally delivering a monopolar electrode to a renal blood vessel of the patient and in proximity to a post-ganglionic nerve that innervates the kidney;

electrically coupling a ground electrode to an exterior of the patient; and

delivering an electric field between the monopolar electrode and the ground electrode to at least partially denervate the kidney,

wherein at least partially denervating the kidney results in a therapeutically beneficial reduction in blood pressure of the patient.

11. The method of claim 10 wherein transluminally delivering a monopolar electrode to a renal blood vessel of the patient comprises:

positioning an expandable member carrying two or more electrodes within a renal artery of the patient in a low-profile delivery arrangement; and

transforming the expandable member into a treatment arrangement to place the two or more electrodes in apposition with a wall of the renal artery before delivering the electric field.

12. The method of claim 11 wherein the expandable member comprises a basket.

13. The method of claim 10 wherein transluminally delivering a monopolar electrode to a renal blood vessel of the patient comprises placing the monopolar electrode in contact with a wall of a renal artery of the patient and proximate to the post-ganglionic nerve.

14. The method of claim 10 wherein transluminally delivering a monopolar electrode to a renal blood vessel of the patient comprises transluminally delivering a catheter carrying the monopolar electrode to a renal artery of the patient via a guidewire.

15. The method of claim 14 wherein the catheter comprises a basket with a plurality of struts and monopolar electrodes on each strut, and wherein transluminally delivering the catheter comprises delivering the basket to the renal artery in a delivery arrangement and transforming the basket to a deployed configuration to place the monopolar electrodes carried by the struts in apposition with an inner wall of the renal artery.

16. The method of claim 10, further comprising removing the monopolar electrode from the patient after delivering the electric field.

17. The method of claim 10 wherein delivering an electric field to at least partially denervate the kidney comprises thermally altering the post-ganglionic nerve via the electric field.

18. The method of claim 10 wherein delivering an electric field to at least partially denervate the kidney comprises partially ablating the post-ganglionic nerve.

19. The method of claim 10 wherein delivering an electric field to at least partially denervate the kidney comprises ablating the post-ganglionic nerve.