Methods for renal neuromodulation via catheters having expandable treatment members

• US 9,445,867 B1
• Filed: 03/21/2016
• Issued: 09/20/2016
• 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 W
• Application Number:
  US15/075,789
• Publication Number:
  US 20160270847A1
• Time in Patent Office: 183 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 reversible electroporation A61N1/327
• 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
• CPC Class Codes: H05K 999/99 : dummy group

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 reduced profile delivery configuration within a renal artery of a human patient and adjacent to renal nerves;

transforming an expandable member at a distal region of the catheter from the low-profile delivery configuration to a treatment configuration, wherein, in the treatment configuration, the expandable member is sized and shaped to place a plurality of electrodes arranged thereabout into apposition with an inner wall of the renal artery of the patient;

selectively energizing a first electrode group carried by the expandable member to deliver a first bipolar energy field to the renal nerves; and

selectively energizing a second electrode group carried by the expandable member to deliver a second bipolar energy field to the renal nerves,

wherein delivering the first and second bipolar energy fields blocks or attenuates neural signaling along the renal nerves.

2. The method of claim 1 wherein the expandable member comprises a basket having a plurality of struts, and wherein transforming the expandable member from the low-profile delivery configuration to the treatment configuration comprises expanding the basket such that electrodes arranged along the individual struts are placed into apposition with the inner wall of the renal artery.

3. The method of claim 2 wherein the basket is composed of nitinol.

4. The method of claim 2 wherein the basket comprises a laser-cut hypotube.

5. The method of claim 2 wherein the basket is positioned within the renal artery in the low-profile delivery configuration within a delivery sheath, and wherein the basket is configured to self-expand to the treatment configuration upon removal from the sheath.

6. The method of claim 2 wherein the individual electrodes are affixed to an outside surface of corresponding struts of the basket, and wherein each strut includes at least one electrode.

7. The method of claim 1 wherein the expandable member comprises a balloon, and wherein transforming the expandable member from the low-profile delivery configuration to the treatment configuration comprises expanding the balloon such that electrodes arranged thereabout are placed into contact with the inner wall of the renal artery.

8. The method of claim 7 wherein transforming the balloon from the low-profile delivery configuration to the treatment configuration comprises occluding blood flow within the renal vessel while the balloon is in the treatment configuration.

9. The method of claim 1 wherein blocking or attenuating neural signaling along the renal nerves results in a therapeutically beneficial reduction in blood pressure of the patient.

10. The method of claim 1 wherein selectively energizing the first electrode group and selectively energizing the second electrode group occurs simultaneously.

11. The method of claim 1 wherein selectively energizing the first electrode group and selectively energizing the second electrode group occurs sequentially.

12. The method of claim 1 wherein intravascularly positioning a catheter in a reduced profile delivery configuration within a renal artery of the patient comprises delivering the catheter over a guidewire.

13. The method of claim 1, further comprising monitoring a parameter of the catheter and/or tissue within the patient before and during delivery of the first and second bipolar energy fields.

14. The method of claim 13 wherein monitoring a parameter comprises monitoring temperature, power, and/or impedance.

15. The method of claim 13, further comprising altering delivery of at least one of the first and second bipolar energy fields in response to the monitored parameter.

16. The method of claim 13 wherein monitoring a parameter comprises monitoring temperature of the tissue, and wherein the method further comprises maintaining the tissue at a desired temperature during delivery of the first and second bipolar energy fields.

17. The method of claim 1 wherein delivering the first and second bipolar energy fields to the renal nerves comprises partially ablating the renal nerves of the patient.

18. The method of claim 1 wherein delivering the first and second bipolar energy fields to the renal nerves comprises ablating one or more renal nerves of the patient.

19. The method of claim 1 wherein delivering the first and second bipolar energy fields to the renal nerves comprises thermally altering the renal nerves in a manner that reduces neural traffic to and from a kidney of the patient.

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

positioning an expandable member of a renal denervation catheter at an intravascular location within a renal artery of a human patient and adjacent to neural fibers innervating a kidney of the patient;

transforming the expandable member from a low-profile delivery state to an expanded treatment state wherein, in the treatment state, the expandable member is sized to place a first set of electrodes carried by a first region of the expandable member and a second set of electrodes carried by a second, different region of the expandable member in contact with target tissue at or near the neural fibers; and

ablating the neural fibers innervating the kidney via radio frequency (RF) energy delivered from the first and second sets of electrodes.

21. The method of claim 20 wherein positioning an expandable member of a renal denervation catheter within a renal artery comprises positioning an expandable basket carrying the first and second sets of electrodes within the renal artery.

22. The method of claim 20 wherein positioning an expandable member of a renal denervation catheter within a renal artery comprises positioning a balloon carrying the first and second sets of electrodes within the renal artery.

23. The method of claim 20 wherein ablating the neural fibers innervating the kidney results in a therapeutically beneficial reduction in blood pressure of the patient.

24. The method of claim 20, further comprising monitoring a parameter of the renal denervation catheter and/or tissue within the patient before and during delivery of the RF energy.

25. The method of claim 24 wherein monitoring a parameter comprises monitoring temperature, power, and/or impedance, and wherein the method further comprises altering delivery or the RF energy in response to the monitored parameter.