Methods for catheter-based renal neuromodulation

• US 9,327,122 B2
• Filed: 02/02/2015
• Issued: 05/03/2016
• 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:
  US14/611,651
• Publication Number:
  US 20150314127A1
• Time in Patent Office: 456 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 18/12 by passing a current through the tissue to be heated, e.g. high-frequency current
• CPC Class Codes: A61B 18/1206 Generators therefor
• 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 2018/00059 Material properties
• 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 2018/00648 using more than one sensed parameter
• CPC Class Codes: A61B 2018/00791 Temperature
• 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: A61N 1/05 : for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• 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
• CPC Class Codes: A61N 1/36117 : for treating hypertension
• CPC Class Codes: A61N 1/36139 : with automatic adjustment

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 catheter-based renal neuromodulation, the method comprising:

intravascularly positioning an electrode of a catheter within renal vasculature of a human patient and proximate to neural fibers that innervate a kidney of the patient; and

delivering an electric field between the electrode and a ground pad coupled to an exterior of the patient, thereby thermally inhibiting neural communication along the neural fibers,

wherein delivering the electric field and thermally inhibiting neural communication along the neural fibers results in a therapeutically beneficial reduction in blood pressure of the patient.

2. The method of claim 1 wherein intravascularly positioning an electrode of a catheter within renal vasculature of a human patient comprises intravascularly positioning the electrode of the catheter within a renal artery of the patient.

3. The method of claim 2 wherein intravascularly positioning the electrode of the catheter within the renal artery of the patient comprises placing the electrode in apposition with an inner wall of the renal artery.

4. The method of claim 1 wherein thermally inhibiting neural communication along the neural fibers comprises blocking neural traffic to and/or from the kidney of the patient.

5. The method of claim 1 wherein delivering an electric field between the electrode and a ground pad causes ablation of the neural fibers.

6. The method of claim 1 wherein delivering an electric field between the electrode and a ground pad causes partial ablation of the neural fibers.

7. The method of claim 1 wherein intravascularly positioning an electrode of a catheter within renal vasculature of a human patient comprises positioning the catheter via a guide catheter.

8. The method of claim 1 wherein intravascularly positioning an electrode of a catheter within renal vasculature of a human patient comprises intravascularly positioning the catheter via a guide wire.

9. The method of claim 1 wherein the electrode comprises a helical configuration, and wherein intravascularly positioning an electrode of a catheter within renal vasculature of a human patient comprises positioning the catheter such that the helical electrode contacts an inner wall of a renal artery of the patient before delivering the electric field between the helical electrode and the ground pad.

10. The method of claim 1 wherein the catheter comprises an expandable basket carrying a plurality of electrodes, and wherein:

intravascularly positioning an electrode of a catheter within renal vasculature of a human patient comprises delivering the basket to a renal artery of the patient in a delivery configuration and transforming the basket from the delivery configuration to a deployed configuration at a target treatment site such that each of the electrodes is in apposition with an inner wall of the renal artery; and

delivering an electric field between the electrode and a ground pad comprises delivering the electric field between all or a subset of the electrodes and the ground pad to thermally inhibit neural communication along the neural fibers.

11. The method of claim 1 wherein:

intravascularly positioning an electrode of a catheter within renal vasculature of a human patient comprises positioning a first electrode of a first catheter in a first renal artery of the patient and proximate to first neural fibers that innervate a first kidney of the patient; and

delivering an electric field between the electrode and a ground pad comprises delivering a first electric field between the first electrode and a first ground pad coupled to the exterior of the patient to thermally inhibit neural communication along the first neural fibers,

wherein, after delivering the first electric field, the method further comprises—

removing the first catheter from the patient;

intravascularly positioning a second electrode of a second catheter within a second renal artery of the patient and proximate to second neural fibers that innervate a second kidney of the patient; and

delivering a second electric field between the second electrode and a second ground pad,

wherein the second electric field thermally inhibits neural communication along the second neural fibers.

12. The method of claim 1 wherein delivering the electric field and thermally inhibiting neural communication along the neural fibers further results in a therapeutically beneficial reduction in sympathetic overactivity of the patient.

13. The method of claim 1, further comprising monitoring a parameter of target tissue and/or non-target tissue within the patient before and during delivery of the electric field.

14. The method of claim 13, further comprising altering delivery of the electric field in response to the monitored parameter.

15. A method of performing renal denervation of a human patient with a diagnosed condition comprising at least one of heart failure, hypertension, acute myocardial infarction, impaired renal function, or chronic renal failure, the method comprising:

attaching a ground pad to an exterior of the patient;

passing a renal denervation catheter comprising a monopolar electrode through vasculature of the patient to a renal blood vessel such that the monopolar electrode is located proximate renal nerves of the patient; and

ablating the renal nerves via electrical energy delivered in a monopolar fashion between the monopolar electrode and the ground pad,

wherein ablating the renal nerves of the patient attenuates neural communication along the renal nerves to thereby improve a measurable physiological parameter corresponding to the diagnosed condition of the patient.

16. The method of claim 15 wherein ablating the renal nerves via electrical energy delivered in a monopolar fashion comprises reducing efferent neural activity across the renal nerves.

17. The method of claim 15 wherein ablating the renal nerves via electrical energy delivered in a monopolar fashion comprises reducing afferent neural activity across the renal nerves.

18. The method of claim 15 wherein ablating the renal nerves via electrical energy delivered in a monopolar fashion comprises at least partially denervating a kidney of the patient.

19. The method of claim 15, further comprising removing the renal denervation catheter from the patient after ablating the renal nerves.

20. The method of claim 15 wherein ablating the renal nerves via electrical energy delivered in a monopolar fashion comprises ablating the renal nerves at a first treatment site along the renal blood vessel, and wherein the method further comprises:

repositioning the monopolar electrode at a second treatment site within the renal blood vessel after ablating the renal nerves at a first treatment site; and

after repositioning, energizing the electrode to deliver electrical energy in a monopolar fashion to renal nerves at the second treatment site along the renal blood vessel.

21. The method of claim 15 wherein the renal denervation catheter further comprises one or more monitoring elements located proximate to the monopolar electrode and configured to monitor temperature and/or impedance, and wherein the method further comprises controlling ablating the renal nerves based, at least in part, on the monitored temperature and/or impedance.