Dry electrodes for transcutaneous nerve stimulation

• US 10,814,130 B2
• Filed: 01/07/2019
• Issued: 10/27/2020
• Est. Priority Date: 07/08/2016
• Status: Active Grant

• Current Assignee: Cala Health, Inc.
• Original Assignee: Cala Health, Inc.
• Inventors: Wong, Serena HanYing, Schulte, Gregory T., Hamner, Samuel Richard, Rosenbluth, Kathryn H., Colombo, John Vincent
• Primary Examiner(s): Malamud, Deborah L
• Application Number:
  US16/241,846
• Publication Number:
  US 20190134393A1
• Time in Patent Office: 659 Days
• CPC Class Codes: A61B 5/681 Wristwatch-type devices
• CPC Class Codes: A61N 1/04 Electrodes electrosurgical electrodes A61B18/14
• CPC Class Codes: A61N 1/0456 Specially adapted for transcutaneous electrical nerve stimulation [TENS]
• CPC Class Codes: A61N 1/0476 Array electrodes (including any electrode arrangement with more than one electrode for at least one of the polarities)
• CPC Class Codes: A61N 1/0484 Garment electrodes worn by the patient
• CPC Class Codes: A61N 1/0492 Patch electrodes A61N1/0412, A61N1/0428 take precedence
• CPC Class Codes: A61N 1/18 Applying electric currents by contact electrodes
• CPC Class Codes: A61N 1/32 alternating or intermittent currents applying electric fields by inductive or capacitive coupling A61N1/40; microwave apparatus A61N5/02
• CPC Class Codes: A61N 1/36 for stimulation
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: A61N 1/36021 for treatment of pain
• CPC Class Codes: A61N 1/36025 for treating a mental or cerebral condition
• CPC Class Codes: A61N 1/36031 using physiological parameters for adjustment
• CPC Class Codes: A61N 1/36067 Movement disorders, e.g. tremor or Parkinson disease stimulating motor muscle A61N1/36003
• CPC Class Codes: A61N 1/3787 from an external energy source

Abstract

Disclosed herein are systems, devices, and methods for peripheral nerve stimulation, particularly for treating tremor. The nerve stimulation may be accomplished by a wearable nerve stimulation device, such as a band configured to be worn on the wrist or other body part. The device can accomplish targeted nerve stimulation using circumferentially spaced electrodes. In some embodiments, the device may use only the same number of electrodes as the number of nerves that are to be stimulated. A biphasic charge-balanced waveform may be used to selectively stimulate a nerve near one of the activated electrodes but not to stimulate the nerve near the other activated electrode. The device may use dry electrodes for long-term, repeated use. The dry electrodes may include a conductive base layer and a polymeric, plastic or rubber skin contact layer comprising a conductive filler. The filler may be a powder, fiber, conductive coating, etc.

Claims

1. A dry electrode for transcutaneous electrical stimulation, the dry electrode comprising:

a conductive backing layer; and

a skin contact layer disposed on the conductive backing layer, the skin contact layer configured to deliver electrical current from the conductive backing layer to the skin for transcutaneous electrical stimulation, the skin contact layer comprising a polymer, plastic, or rubber material, and a conductive filler material dispersed substantially evenly throughout the polymer, plastic, or rubber material, the skin contact layer comprising a thickness of between 1 mm and 10 mm, wherein the conductive filler material comprises single wall carbon nanotubes,

wherein the skin contact layer comprises a skin facing surface that is not coated with a hydrogel or liquid,

wherein a loading of single wall carbon nanotubes is between about 1% and about 5%, and

wherein a homogeneity of the conductive filler material is such that there is less than about a 5% difference in resistivity across the skin contact layer.

2. The dry electrode of claim 1, wherein the dry electrode has a bulk resistivity of between about 50 ohm-cm and about 1,000 ohm-cm,

wherein the skin contact layer comprises silicone,

wherein the dry electrode is configured to be disposed on a wearable band, and

wherein the skin contact layer has a Shore A durometer of between about 30 A and about 50 A.

3. The dry electrode of claim 1, wherein the skin contact layer comprises silicone.

4. The dry electrode of claim 1, wherein the conductive filler material further comprises silver coated glass bubbles.

5. The dry electrode of claim 4, wherein the loading of silver coated glass bubbles is between about 3% and about 30% of the skin contact layer.

6. The dry electrode of claim 1, wherein the dry electrode has a bulk resistivity of between about 50 ohm-cm and about 1,000 ohm-cm.

7. The dry electrode of claim 1, wherein the skin contact layer has a Shore A durometer of between about 30 A and about 50 A.

8. A dry electrode for transcutaneous electrical stimulation, the dry electrode comprising:

a conductive backing layer; and

a skin contact layer disposed on the conductive backing layer, the skin contact layer configured to deliver electrical current from the conductive backing layer to the skin for transcutaneous electrical stimulation, the skin contact layer comprising a polymer, plastic, or rubber material, and a conductive filler material dispersed throughout the polymer, plastic, or rubber material, the skin contact layer comprising a thickness of between 1 mm and 10 mm, wherein the conductive filler material comprises single wall carbon nanotubes,

wherein the skin contact layer comprises a skin facing surface that is not coated with a hydrogel or liquid,

wherein a loading of single wall carbon nanotubes is between about 1% and about 5%.

9. The dry electrode of claim 8, wherein the dry electrode has a bulk resistivity of between about 50 ohm-cm and about 1,000 ohm-cm,

wherein the skin contact layer has a Shore A durometer of between about 30 A and about 50 A,

wherein a homogeneity of the conductive filler material is such that there is less than about a 5% difference in resistivity across the skin contact layer,

wherein the loading of single wall carbon nanotubes is between about 1% and about 5%, and

wherein the skin contact layer comprises silicone.

10. The dry electrode of claim 8, wherein the skin contact layer comprises silicone.

11. A dry electrode for transcutaneous electrical stimulation, the dry electrode comprising:

a conductive backing layer; and

a skin contact layer disposed on the conductive backing layer, the skin contact layer configured to deliver electrical current from the conductive backing layer to the skin for transcutaneous electrical stimulation, the skin contact layer further comprising a conductive filler material dispersed substantially evenly throughout a polymer, plastic, or rubber material, the skin contact layer comprising a thickness of between 0.5 mm and 10 mm, wherein the conductive filler material comprises single wall carbon nanotubes,

wherein the skin contact layer has a skin facing surface that is not coated with a hydrogel or liquid,

wherein a loading of single wall carbon nanotubes is less than about 5%.

12. The dry electrode of claim 11,

wherein the skin contact layer has a Shore hardness between about 10 A to about 100 A,

wherein the skin contact layer has a volume resistivity between about 1 ohm*cm and about 2000 ohm*cm,

wherein a measured resistance or conductance at a plurality of points across the skin facing surface of the skin contact layer has a standard deviation of within about 50% of the average measured resistance or conductance, and

wherein the skin contact layer comprises silicone.

13. The dry electrode of claim 11, wherein the conductive backing layer comprises a metal foil.

14. The dry electrode of claim 13, wherein the metal foil is disposed on a flexible polymer substrate.

15. The dry electrode of claim 11, wherein the conductive filler material comprises a powder or fine particulate material.

16. The dry electrode of claim 11, wherein the conductive backing layer comprises porous material treated with a conductive coating.

17. The dry electrode of claim 11, wherein the skin contact layer has a Shore hardness between about 10 A to about 100 A.

18. The dry electrode of claim 11, wherein the skin contact layer has a Shore hardness between about 25 A to about 55 A.

19. The dry electrode of claim 11, wherein a measured resistance or conductance at a plurality of points across the skin facing surface of the skin contact layer has a standard deviation of within about 25% of the average measured resistance or conductance.

20. The dry electrode of claim 11, wherein the loading of single wall carbon nanotubes is between about 1% and about 5%.