Methods and apparatus for intravascularly-induced neuromodulation

• US 10,376,311 B2
• Filed: 09/25/2018
• 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, Zadno, Nicolas, Clark, Benjamin J., Thai, Erik
• Primary Examiner(s): Bockelman, Mark
• Application Number:
  US16/141,042
• Publication Number:
  US 20190090943A1
• Time in Patent Office: 322 Days
• CPC Class Codes: A61B 17/12136 Balloons
• 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 2018/00083 low, i.e. electrically insulating
• CPC Class Codes: A61B 2018/00285 Balloons
• CPC Class Codes: A61B 2018/00434 Neural system
• CPC Class Codes: A61B 2018/00613 Irreversible electroporation reversible electroporation A61N1/327
• CPC Class Codes: A61M 25/0108 using radio-opaque or ultrasound markers
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61N 1/327 for enhancing the absorption properties of tissue, e.g. by electroporation
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: A61N 1/36121 Production of neurotransmitters; Modulation of genes expression
• CPC Class Codes: A61N 1/36182 Direction of the electrical field, e.g. with sleeve around stimulating electrode
• CPC Class Codes: A61N 1/37205 Microstimulators, e.g. implantable through a cannula
• CPC Class Codes: A61N 1/40 Applying electric fields by inductive or capacitive coupling microwave apparatus A61N5/00; Applying radio-frequency signals

Abstract

Methods and apparatus are provided for intravascularly-induced neuromodulation using a pulsed electric field, e.g., to effectuate irreversible electroporation or electrofusion, necrosis and/or inducement of apoptosis, alteration of gene expression, changes in cytokine upregulation, etc., in target neural fibers. In some embodiments, the intravascular PEF system comprises a catheter having a pair of bipolar electrodes for delivering the PEF, with a first electrode positioned on a first side of an impedance-altering element and a second electrode positioned on an opposing side of the impedance-altering element. A length of the electrodes, as well as a separation distance between the first and second electrodes, may be specified such that, with the impedance-altering element deployed in a manner that locally increases impedance within a patient'"'"'s vessel, e.g., with the impedance-altering element deployed into contact with the vessel wall at a treatment site within the patient'"'"'s vasculature, a magnitude of applied voltage delivered across the bipolar electrodes necessary to achieve desired neuromodulation is reduced relative to an intravascular PEF system having similarly spaced electrodes but no (or an undeployed) impedance-altering element. In a preferred embodiment, the impedance-altering element comprises an inflatable balloon configured to locally increase impedance within a patient'"'"'s vasculature. The methods and apparatus of the present invention may be used to modulate a neural fiber that contributes to renal function.

Claims

1. A method, comprising:

intravascularly positioning a catheter within a renal artery of a hypertensive human patient;

transforming a balloon carried by the catheter from a delivery state to an expanded state at a treatment site within the renal artery; and

delivering electrical energy via a pair of bipolar electrodes carried by the catheter to induce renal denervation,

wherein inducing renal denervation results in a therapeutically beneficial reduction in blood pressure of the patient.

2. 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 electrical energy.

3. The method of claim 2 wherein monitoring a parameter comprises monitoring temperature of target tissue, and wherein the method further comprises maintaining the target tissue at a desired temperature during delivery of the electrical energy.

4. The method of claim 2, further comprising altering delivery of the electrical energy in response to the monitored parameter.

5. The method of claim 1 wherein intravascularly positioning a catheter within a renal artery of a hypertensive human patient comprises intravascularly delivering the catheter to the renal artery over a guidewire.

6. The method of claim 1 wherein intravascularly positioning a catheter within a renal artery of a hypertensive human patient comprises intravascularly delivering the catheter to the renal artery within a guide catheter.

7. The method of claim 1 wherein delivering electrical energy via a pair of bipolar electrodes carried by the catheter to induce renal denervation comprises ablating renal nerves innervating a kidney of the patient via the electrical energy delivered by the pair of bipolar electrodes.

8. The method of claim 1 wherein delivering electrical energy via a pair of bipolar electrodes carried by the catheter to induce renal denervation comprises partially ablating renal nerves innervating a kidney of the patient via the electrical energy delivered by the pair of bipolar electrodes.

9. The method of claim 1 wherein delivering electrical energy via a pair of bipolar electrodes carried by the catheter to induce renal denervation comprises inducing renal denervation via radio frequency (RF) energy delivered by the pair of bipolar electrodes.

10. The method of claim 1 wherein delivering electrical energy via a pair of bipolar electrodes carried by the catheter to induce renal denervation comprises inducing renal denervation via pulsed electrical energy delivered by the pair of bipolar electrodes.

11. The method of claim 1 wherein, in the expanded state at the treatment site within the renal artery, the balloon is sized and shaped to temporarily occlude blood flow within the renal artery.

12. The method of claim 1 wherein the balloon comprises a semi-compliant balloon.

13. The method of claim 1 wherein the balloon comprises a non-compliant balloon.

14. The method of claim 1 wherein, in the expanded state at the treatment site within the renal artery, the balloon has a length of 5 mm.

15. The method of claim 1 wherein the balloon is configured to locally increase impedance between the pair of bipolar electrodes during delivery of the electrical energy.

16. The method of claim 15 wherein locally increasing impedance further comprises directing the thermal field across a wall of the renal artery between the pair of bipolar electrodes.

17. The method of claim 1 wherein the bipolar pair of electrodes comprises a first pair of bipolar electrodes arranged about the balloon, and wherein the catheter further comprises a second pair of bipolar electrodes arranged thereabout.

18. The method of claim 1 wherein the pair of bipolar electrodes are carried by a shaft of the catheter.

19. The method of claim 1, further comprising:

transforming the balloon from the expanded state to the delivery state; and

removing the catheter from the patient after delivering the electrical energy to induce renal denervation to conclude the procedure.