Methods for monopolar renal neuromodulation

• US 9,308,043 B2
• Filed: 11/20/2014
• Issued: 04/12/2016
• 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:
  US14/548,810
• Publication Number:
  US 20150080884A1
• Time in Patent Office: 509 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 reversible electroporation A61N1/327
• 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 diagnosed hypertension by renal neuromodulation of a human patient, the method comprising:

placing a monopolar electrode within renal vasculature and in contact with a vessel wall of the renal vasculature of the patient, wherein the monopolar electrode is proximate to a post-ganglionic nerve innervating a kidney of the 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 to reduce 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 reducing neural communication along the post-ganglionic nerve comprises ablating the nerve.

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

4. A method for treating a human patient with diagnosed hypertension via renal neuromodulation, the method comprising:

placing a monopolar electrode within a renal artery of the patient, wherein the monopolar electrode is adjacent to a post-ganglionic nerve innervating a kidney of the patient;

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

delivering an electric field between the monopolar electrode and the ground electrode, wherein the electric field reduces neural communication along the post-ganglionic nerve,

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

5. The method of claim 4 wherein placing a monopolar electrode within a renal artery of the patient comprising intravascularly delivering the electrode to the renal artery via a femoral artery and an aorta of the patient.

6. The method of claim 4 wherein reducing neural communication along the post-ganglionic nerve comprises blocking neural traffic to and/or from the kidney.

7. The method of claim 4 wherein reducing neural communication along the post-ganglionic nerve comprises attenuating afferent neural traffic to and/or from the kidney.

8. The method of claim 4 wherein reducing neural communication along the post-ganglionic nerve comprises attenuating efferent neural traffic to and/or from the kidney.

9. The method of claim 4 wherein the monopolar electrode is carried by an expandable basket, and wherein placing a monopolar electrode within a renal artery of the patient comprises delivering the expandable basket to the renal artery 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.

10. The method of claim 4, further comprising monitoring a parameter of tissue within the patient before and during delivery of the electric field.

11. The method of claim 10, further comprising modifying delivery of the electric field in response to the monitored parameter.

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

13. The method of claim 4 wherein reducing neural communication along the post-ganglionic nerve comprises partially ablating the post-ganglionic nerve.

14. The method of claim 4 wherein placing a monopolar electrode within a renal artery of the patient comprises:

positioning an expandable member carrying two or more electrodes within the renal artery 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.

15. The method of claim 14 wherein the expandable member comprises a balloon.

16. The method of claim 4 wherein placing a monopolar electrode within a renal artery of the patient comprises placing the electrode in contact with a vessel wall of the renal artery adjacent to the post-ganglionic nerve.

17. The method of claim 4, further comprising removing the monopolar electrode from the patient after delivering the electric field.

18. A method for catheter-based renal neuromodulation, the method comprising:

intravascularly positioning a catheter having a monopolar electrode within a renal artery of a human patient and in vicinity of renal nerves innervating a kidney of the patient; and

reducing neural communication to and from the kidney by ablating the renal nerves of the patient via electrical energy delivered between the monopolar electrode and a ground pad on the skin of the patient,

wherein reducing neural communication to and from the kidney results in improved cardio-renal function of the patient.

19. The method of claim 18 wherein intravascularly positioning a catheter having a monopolar electrode within a renal artery of the patient comprises intravascularly delivering the catheter to the renal artery via a guidewire.

20. The method of claim 18 wherein the catheter comprises a basket with a plurality of struts and monopolar electrodes on each strut, and wherein intravascularly positioning a catheter having a monopolar electrode within a renal artery comprises intravascularly 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.

21. The method of claim 18 wherein reducing neural communication to and from the kidney by ablating the renal nerves of the patient comprises thermally altering the renal nerves via the electrical energy.

22. The method of claim 18, further comprising removing the catheter from the patient after ablating the renal nerves.