Methods and apparatus for pulsed electric field neuromodulation via an intra-to-extravascular approach

• US 8,958,871 B2
• Filed: 01/14/2011
• Issued: 02/17/2015
• Est. Priority Date: 04/08/2002
• Status: Expired due to Fees

• Current Assignee: Medtronic Ardian Luxembourg SARL (Medtronic Plc)
• Original Assignee: Medtronic Ardian Luxembourg SARL (Medtronic Plc)
• Inventors: Demarais, Denise, Clark, Benjamin J., Zadno, Nicolas, Thai, Erik, Gifford, Hanson III
• Primary Examiner(s): MALAMUD, DEBORAH LESLIE
• Application Number:
  US13/007,370
• Publication Number:
  US 20110202098A1
• Time in Patent Office: 1,495 Days
• Field of Search: 607 1- 3, 607/9, 607/72
• US Class Current: 607/3
• CPC Class Codes: A61B 18/1206 Generators therefor
• CPC Class Codes: A61B 18/1477 Needle-like probes
• CPC Class Codes: A61B 2018/0022 Balloons
• CPC Class Codes: A61B 2018/00267 having a basket shaped structure
• 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 2018/00505 Urinary tract
• CPC Class Codes: A61B 2018/00613 Irreversible electroporation reversible electroporation A61N1/327
• CPC Class Codes: A61B 2018/126 bipolar
• CPC Class Codes: A61M 37/00 Other apparatus for introducing media into the body for reproduction or fertilisation A61B17/425; apparatus for iontophoresis or cataphoresis A61N1/30; Percutany, i.e. introducing medicines into the body by diffusion through the skin salt baths A61H33/04
• CPC Class Codes: A61M 5/14 Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
• 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 1/0514 Electrodes for the urinary tract
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/321 Electromedical belts
• 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

Abstract

Methods and apparatus are provided for pulsed electric field neuromodulation via an intra-to-extravascular approach, e.g., to effectuate irreversible electroporation or electrofusion, necrosis and/or inducement of apoptosis, alteration of gene expression, changes in cytokine upregulation and other conditions in target neural fibers. In some embodiments, the ITEV PEF system comprises an intravascular catheter having one or more electrodes configured for intra-to-extravascular placement across a wall of patient'"'"'s vessel into proximity with target neural fibers. With the electrode(s) passing from an intravascular position to an extravascular position prior to delivery of the PEF, a magnitude of applied voltage or energy delivered via the electrode(s) and necessary to achieve desired neuromodulation may be reduced relative to an intravascular PEF system having one or more electrodes positioned solely intravascularly. The methods and apparatus of the present invention may, for example, be used to modulate one or more target neural fibers that contribute to renal function.

Claims

1. A method for pulsed electric field neuromodulation via an intra-to-extravascular approach, the method comprising:

intravascularly advancing an electrode to a treatment site within vasculature of a human patient;

passing a portion of the electrode through at least a portion of a wall of the vasculature to position the electrode at an extravascular location via an intra-to-extravascular approach; and

extravascularly delivering a pulsed electric field via the electrode to induce neuromodulation.

2. The method of claim 1, wherein intravascularly advancing an electrode to a treatment site within vasculature of a human patient further comprises intravascularly moving the electrode to a treatment site within a renal artery of the patient.

3. The method of claim 1, wherein intravascularly advancing an electrode to a treatment site within vasculature of a human patient further comprises intravascularly moving an intravascular catheter having the electrode to the treatment site within the vasculature of the patient.

4. The method of claim 3, wherein passing a portion of the electrode through at least a portion of a wall of the vasculature to positioning the electrode at an extravascular location via an intra-to-extravascular approach further comprises expanding an expandable element of the catheter.

5. The method of claim 1, wherein intravascularly advancing an electrode to a treatment site within vasculature of a human patient further comprises moving the electrode through an intravascular catheter positioned at the treatment site.

6. The method of claim 1, wherein extravascularly delivering a pulsed electric field to induce neuromodulation further comprises extravascularly applying the pulsed electric field to modulate a neural fiber that contributes to renal function.

7. The method of claim 6, wherein modulating a neural fiber that contributes to renal function further comprises inducing, in the neural fiber, an effect chosen from the group consisting of irreversible electroporation, electrofusion, necrosis, apoptosis, gene expression alteration, cytokine upregulation alteration, and combinations thereof.

8. The method of claim 1 wherein passing a portion of the electrode through at least a portion of a wall of the vasculature to position the electrode at an extravascular location via an intra-to-extravascular approach further comprises piercing the wall of the vasculature, and advancing the electrode through the wall piercing.

9. The method of claim 8, wherein piercing the wall of the vasculature further comprises forcing the electrode through the wall of the vasculature.

10. The method of claim 1, wherein intravascularly advancing an electrode to a treatment site further comprises advancing at least one bipolar electrode pair to the treatment site.

11. The method of claim 10, wherein passing a portion of the electrode through at least a portion of a wall of the vasculature to position the electrode at an extravascular location via an intra-to-extravascular approach further comprises moving the bipolar electrode pair extravascularly, and wherein extravascularly delivering a pulsed electric field further comprises extravascularly delivering the pulsed electric field across the bipolar electrode pair.

12. The method of claim 10, wherein passing a portion of the electrode through at least a portion of a wall of the vasculature to position the electrode at an extravascular location via an intra-to-extravascular approach further comprises positioning a first electrode of the bipolar electrode pair at the extravascular location and positioning a second electrode of the bipolar electrode pair at an intravascular location.

13. The method of claim 1 further comprising infusing an agent to enhance the neuromodulation.

14. The method of claim 1 further comprising infusing an agent to protect non-target tissue.