Methods and apparatus for monopolar renal neuromodulation

• US 10,376,312 B2
• Filed: 10/05/2018
• Issued: 08/13/2019
• 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, III, Hanson, Deem, Mark, Levin, Howard R., Gelfand, Mark, Zadno, Nicolas
• Primary Examiner(s): Bockelman, Mark
• Application Number:
  US16/153,376
• Publication Number:
  US 20190090944A1
• Time in Patent Office: 312 Days
• 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, comprising:

intravascularly positioning a renal denervation catheter in a low-profile delivery arrangement within a renal blood vessel of a hypertensive human patient and adjacent to renal nerves innervating a kidney of the patient;

transforming the catheter from the low-profile delivery arrangement to an expanded arrangement at a treatment site within the renal blood vessel,

wherein, in the expanded arrangement, a plurality of energy delivery elements of the renal denervation catheter are positioned in contact with an inner wall of the renal blood vessel of the patient; and

delivering an electric field between the plurality of energy delivery elements and a ground pad coupled to an exterior of the patient,

wherein delivering the electric field comprises delivering a substantially uniform circumferential energy field about the renal blood vessel at the treatment site, and

wherein delivering the electric field attenuates neural communication along the renal nerves and results in a therapeutically beneficial reduction in blood pressure of the patient.

2. The method of claim 1 wherein the renal denervation catheter further comprises one or more monitoring elements located adjacent the plurality of energy delivery elements and configured to monitor a parameter of the renal denervation catheter and/or tissue within the patient before and during delivery of the electric field and altering delivery of the electric field in response to the monitored parameter.

3. The method of claim 2 wherein monitoring a parameter comprises monitoring temperature, power, and/or impedance.

4. The method of claim 1 wherein intravascularly positioning a renal denervation catheter within a renal blood vessel of a hypertensive human patient comprises intravascularly positioning the renal denervation catheter within a renal artery of the patient.

5. The method of claim 1 wherein intravascularly positioning a renal denervation catheter within a renal blood vessel of a hypertensive human patient comprises positioning the renal denervation catheter via a guide catheter.

6. The method of claim 1 wherein intravascularly positioning a renal denervation catheter within a renal blood vessel of a hypertensive human patient comprises intravascularly positioning the renal denervation catheter via a guide wire.

7. The method of claim 1 wherein delivering an electric field between the plurality of energy delivery elements and the ground pad coupled to the exterior of the patient causes ablation of the renal nerves.

8. The method of claim 1 wherein delivering an electric field between the plurality of energy delivery elements and the ground pad coupled to the exterior of the patient causes partial ablation of the renal nerves.

9. The method of claim 1 wherein delivering the electric field and attenuating neural communication along the renal nerves comprises reducing efferent neural activity across the renal nerves.

10. The method of claim 1 wherein delivering the electric field and attenuating neural communication along the renal nerves comprises reducing afferent neural activity across the renal nerves.

11. The method of claim 1, further comprising removing the renal denervation catheter from the patient after delivering the electric field.

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

13. The method of claim 1 wherein the treatment site is a first treatment site and the electric field is a first electric field, and wherein the method further comprises:

repositioning the plurality of energy delivery elements at a second treatment site within the renal blood vessel after delivering the first electric field at the first treatment site; and

after repositioning, delivering a second electric field between the plurality of energy delivery elements and the ground pad at the second treatment site along the renal blood vessel.

14. The method of claim 1 wherein delivering an electric field between the plurality of energy delivery elements and the ground pad comprises delivering a radio frequency (RF) electric field.