Methods and systems of electrode polarity switching in electrical stimulation therapy

• US 9,827,425 B2
• Filed: 09/03/2014
• Issued: 11/28/2017
• Est. Priority Date: 09/03/2013
• Status: Active Grant

• Current Assignee: Paras Holdings LLC
• Original Assignee: EndoStim, Inc.
• Inventors: Glasberg, Ofer, Policker, Shai, Sharma, Virender K., Goode, Paul V., Hogg, Bevil
• Primary Examiner(s): Lee, Erica
• Application Number:
  US14/475,736
• Publication Number:
  US 20150066109A1
• Time in Patent Office: 1,182 Days
• Field of Search: None
• CPC Class Codes: A61B 5/4233 oesophagus
• CPC Class Codes: A61B 5/4238 stomach
• CPC Class Codes: A61B 5/4836 Diagnosis combined with treatment in closed-loop systems or methods A61B5/0036 takes precedence
• CPC Class Codes: A61B 5/6871 Stomach
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: A61N 1/36132 using patient feedback
• CPC Class Codes: A61N 1/36139 with automatic adjustment
• CPC Class Codes: A61N 1/3615 Intensity
• CPC Class Codes: A61N 1/36185 Selection of the electrode configuration

Abstract

Methods for electrically stimulating body tissues to improve function or reduce symptoms provide an electrical stimulation system having two or more electrodes that are capable of being switched independently from a hyperpolarizing (depolarizing) state to a hypopolarizing state. Multiple combinations of hyperpolarizing electrodes and hypopolarizing electrodes are created by polarity switching to determine a polarity configuration having the best performance as determined by symptom reporting and clinical diagnostic tests. Polarity switching is triggered manually or is programmed to be switched automatically. Determining the configuration providing electrical stimulation resulting in the greatest benefit allows the system to be operated with one or more electrodes in a hypopolarizing state, thereby reducing energy requirements, tissue tolerance, and tissue fatigue.

Claims

1. A system for electrically stimulating body tissue, comprising:

a pulse generator;

a controller; and

at least two electrodes operatively connected to said pulse generator and said controller, wherein the controller is programmed to deliver a hyperpolarizing pulse stream through a first one of said two electrodes, said hyperpolarizing pulse stream being sufficient to increase a polarization of said body tissue to a level greater than a resting potential of said body tissue, and is programmed to deliver a hypopolarizing pulse stream through a second one of said two electrodes, said hypopolarizing pulse stream being sufficient to decrease a polarization of said body tissue to a level less than a resting potential of said body tissue, and wherein the controller is configured to switch polarities of said two electrodes such that said first one of said two electrodes delivers the hypopolarizing pulse stream and said second one of said two electrodes delivers the hyperpolarizing pulse stream, wherein said switching of the polarity of said first and second electrodes is adapted to automatically occur when a pH level in a lower esophagus of the patient measures above or below a predetermined threshold value.

2. The system for electrically stimulating body tissue of claim 1 comprising three electrodes.

3. The system for electrically stimulating body tissue of claim 1 comprising four electrodes.

4. The system for electrically stimulating body tissue of claim 1 comprising more than four electrodes.

5. The system for electrically stimulating body tissue of claim 1, wherein said pulse generator and said controller are contained within a metal housing configured as a return electrode, wherein said metal housing is adapted to be implanted a distance further away from a target tissue relative to a distance of said first and second electrodes from said target tissue.

6. The system for electrically stimulating body tissue of claim 5, wherein said metal housing is implanted in a subcutaneous tissue in an abdomen of a patient, in a gastrointestinal tract of a patient, or proximate a gastrointestinal tract of a patient within an abdominal cavity.

7. The system for electrically stimulating body tissue of claim 5, wherein said metal housing comprises hermetic titanium.

8. The system for electrically stimulating body tissue of claim 5, wherein a portion of said metal housing is coated with an electrically insulating material.

9. The system for electrically stimulating body tissue of claim 5, wherein said metal housing also comprises biocompatible plastic with an exposed electrode at the surface.

10. A system for electrically stimulating body tissues comprising:

an electrode; and

a pulse generator, wherein said pulse generator is operatively connected to one electrode, wherein said one electrode is adapted to be implanted proximate a target tissue, wherein said implantable pulse generator comprises a metal housing configured as a return electrode, wherein said implantable pulse generator is adapted to be implanted away a distance further from said target tissue relative to the electrode, wherein said pulse generator is configured to automatically switch the electrode from a hyperpolarizing state to a hypopolarizing state when a pH level in a lower esophagus of the patient measures above or below a predetermined threshold value, wherein said hyperpolarizing state is sufficient to increase a polarization of said target tissue to a level greater than a resting potential of said target tissue, and wherein said hypopolarizing state is sufficient to decrease a polarization of said target tissue to a level less than a resting potential of said target tissue.

11. The system for electrically stimulating body tissues of claim 10, wherein said system comprises three electrodes.

12. The system for electrically stimulating body tissues of claim 10, wherein said system comprises four electrodes.

13. The system for electrically stimulating body tissues of claim 10, wherein said system comprises more than four electrodes.

14. The system for electrically stimulating body tissues of claim 10, wherein said metal housing comprises hermetic titanium.

15. The system for electrically stimulating body tissues of claim 10, wherein a portion of said metal housing is coated with an electrically insulating material.

16. The system for electrically stimulating body tissues of claim 10, wherein said metal housing comprises biocompatible plastic with an exposed electrode at the surface.