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

• US 9,364,280 B2
• Filed: 12/17/2014
• Issued: 06/14/2016
• 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, Clark, Benjamin J., Zadno, Nicolas, Gifford, Hanson III, Thai, Erik
• Primary Examiner(s): MALAMUD, DEBORAH LESLIE
• Application Number:
  US14/574,262
• Publication Number:
  US 20150164583A1
• Time in Patent Office: 545 Days
• US Class Current: 1/1
• 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. An apparatus for electric field neuromodulation, comprising:

an electric field generator;

an elongated element configured to be moved within a vascular structure of a patient;

at least one electrode electrically coupled to the field generator and having an intravascular portion associated with the elongated element and having an extravascular portion configured to be passed through a wall of the vascular structure; and

an actuator associated with the at least one electrode and being configured to move the electrode between a first position in which the extravascular portion of the electrode is within the vascular structure and a second position in which the extravascular portion of the electrode is located at an extravascular location for extravascular delivery of an electric field.

2. The apparatus of claim 1, wherein the at least one electrode comprises at least one bipolar electrode pair having a first electrode and a second electrode, the bipolar electrode pair coupled to the field generator.

3. The apparatus of claim 2, wherein the extravascular portion of the at least one electrode comprises the bipolar electrode pair.

4. The apparatus of claim 2, wherein the intravascular portion of the at least one electrode comprises the first electrode of the bipolar electrode pair and the extravascular portion of the electrode comprises the second electrode of the bipolar electrode pair.

5. The apparatus of claim 2, wherein the first electrode and the second electrode are longitudinally spaced apart from one another in the second position.

6. The apparatus of claim 1, further comprising an external ground pad, wherein the extravascular portion of the at least one electrode is configured for monopolar extravascular delivery of the electric field.

7. The apparatus of claim 1 , wherein the actuator comprises a piercing element configured to pierce a wall of the vascular structure during movement of the extravascular portion of the at least one electrode between the first position and the second position.

8. The apparatus of claim 1 , wherein the extravascular portion of the at least one electrode comprises a piercing element configured to pierce a wall of the vascular structure during movement of the extravascular portion of the at least one electrode between the first position and the second position.

9. The apparatus of claim 1 further comprising infusate, wherein the apparatus is configured for extravascular infusion of the infusate.

10. The apparatus of claim 9, wherein the infusate comprises neuromodulation-enhancing infusate or protective infusate.

11. The apparatus of claim 1, wherein the actuator comprises an inflatable balloon.

12. The apparatus of claim 1, wherein the actuator comprises an expandable cage or basket.

13. The apparatus of claim 1, wherein the actuator comprises a transition element having a profile configured to direct the extravascular portion of the at least one electrode radially outward as the extravascular portion of the at least one electrode is moved between the first position and the second position.