Electrodes, electrode systems, and methods of manufacture

• US 9,211,400 B2
• Filed: 04/13/2012
• Issued: 12/15/2015
• Est. Priority Date: 07/18/2011
• Status: Active Grant

• Current Assignee: DJO LLC (Enovis Corp.)
• Original Assignee: EMPI Incorporated (Enovis Corp.)
• Inventors: Bachinski, Thomas Jerome, Moore, Michael, Dave, Jay, Winn, Joseph
• Primary Examiner(s): Berdichevsky, Aarti B
• Assistant Examiner(s): Schell, Laura
• Application Number:
  US13/446,832
• Publication Number:
  US 20130023816A1
• Time in Patent Office: 1,341 Days
• Field of Search: 604 19- 21, 607 2- 3
• US Class Current: 1/1
• CPC Class Codes: A61B 2562/125 characterised by the manufacture of electrodes
• CPC Class Codes: A61B 2562/227 Sensors with electrical connectors
• CPC Class Codes: A61B 5/25 Bioelectric electrodes therefor
• CPC Class Codes: A61B 5/251 Means for maintaining electrode contact with the body
• CPC Class Codes: A61B 5/259 using conductive adhesive means, e.g. gels
• CPC Class Codes: A61B 5/263 characterised by the electrode materials
• CPC Class Codes: A61B 5/268 containing conductive polymers, e.g. PEDOT:PSS polymers
• CPC Class Codes: A61B 5/274 using snap or button fasteners
• CPC Class Codes: A61B 5/282 Holders for multiple electrodes for introduction into the body A61B5/287
• CPC Class Codes: A61N 1/0428 Specially adapted for iontophoresis, e.g. AC, DC or including drug reservoirs
• CPC Class Codes: A61N 1/044 Shape of the electrode
• CPC Class Codes: A61N 1/0456 Specially adapted for transcutaneous electrical nerve stimulation [TENS]
• CPC Class Codes: A61N 1/048 Electrodes characterised by a specific connection between lead and electrode
• CPC Class Codes: A61N 1/0492 Patch electrodes A61N1/0412, A61N1/0428 take precedence
• CPC Class Codes: A61N 1/30 Apparatus for iontophoresis, i.e. transfer of media in ionic state by an electromotoric force into the body, or cataphoresis
• CPC Class Codes: A61N 1/325 for iontophoresis, i.e. transfer of media in ionic state by an electromotoric force into the body electrodes for external use A61N1/0428
• CPC Class Codes: A61N 1/36014 External stimulators, e.g. with patch electrodes external pacemakers A61N1/3625
• CPC Class Codes: H01R 11/30 End pieces held in contact by a magnet
• CPC Class Codes: H01R 2201/12 for medicine and surgery
• CPC Class Codes: Y10T 29/49155 Manufacturing circuit on or in base

Abstract

Multilayer electrodes, electrode systems, and stimulation systems are disclosed. An electrode may include a conductive layer with a unitary tail, a connector disposed on a distal end of the tail, and a nonconductive top layer disposed along a top portion of the conductive layer. An electrode may include a magnetic lead connector socket, or a receptacle formed by a depression in the conductive layer configured to receive a male connector. An electrode system may include a plurality of conductive zones and a plurality of connectors. A stimulation system may include an electronics layer in electrical contact with a conductive layer via a puncture connection, and may provide an iontophoretic treatment followed by a TENS treatment. Other electrodes, systems and methods are also disclosed.

Claims

1. An iontophoresis delivery system comprising:

an insulating layer;

a nonconductive top layer;

a nonconductive bottom layer;

a first nonconductive element;

a second nonconductive element;

a first electrode, wherein the first electrode is situated between the nonconductive bottom layer and the insulating layer;

a second electrode, wherein the first electrode and the second electrode are spaced apart from each other, wherein the second electrode is ring-shaped and wherein the first electrode is within an interior of the second electrode;

a first electrode reservoir comprising a therapeutic compound, the first electrode reservoir configured to deliver the therapeutic compound into a patient'"'"'s tissue when a DC current is driven into the patient'"'"'s tissue from the first electrode to the second electrode;

a second electrode reservoir;

and wherein the second electrode is situated between the insulating layer and the second electrode reservoir; and

an electronics layer situated between the nonconductive top layer and the nonconductive bottom layer, the electronics layer having a first electronics layer contact point in electrical contact and alignment with a first electrode contact point in the first electrode via a first puncture connection and a second electronics layer contact point in electrical contact and alignment with a second electrode contact point in the second electrode via a second puncture connection, wherein the electronics layer, the nonconductive bottom layer and the first electrode are assembled in a stack, and wherein the stack is punctured to form the puncture connections, wherein the first nonconductive element is positioned below the first electrode contact point and wherein the second nonconductive element is positioned below the second electrode contact point, the electronics layer further comprising pulse generation circuitry configured to;

deliver the DC current to the first electrode for a predetermined period of time to drive the therapeutic compound into the patient'"'"'s tissue;

after delivering the DC current for the predetermined period of time, deliver an AC TENS current from the second electrode to the first electrode.

2. The iontophoresis delivery system of claim 1, further comprising a battery, wherein the pulse generation circuitry is configured to use the battery to power the delivery of the DC current and the delivery of the AC TENS current.

3. The iontophoresis delivery system of claim 1, wherein the electronics layer comprises timer circuitry configured to indicate that the predetermined period of time has elapsed when a predetermined amount of therapeutic compound has been driven into the patient'"'"'s tissue.

4. The iontophoresis delivery system of claim 1, wherein the first electrode comprises a conductive polyvinylchloride or polyurethane impregnated with carbon.

5. The iontophoresis delivery system of claim 1, wherein the first electrode is circle-shaped.

6. The iontophoresis delivery system of claim 1, wherein the electronics layer comprises at least one electrical switch configured to provide an electrical response to a force exerted on a surface of the at least one switch so as to register a button press by a button disposed above the at least one electrical switch and aligned with an aperture in the nonconductive top layer, wherein the at least one electrical switch is in electrical communication with a microprocessor or other circuitry included in the electronics layer configured to initiate or adjust at least one of the DC current or the AC TENS current.

7. The iontophoresis delivery system of claim 1, wherein the electronics layer comprises three electrical switches, wherein each electrical switch is configured to provide an electrical response to a force exerted on a surface of the electrical switch, the system further comprising a button disposed above each of the three electrical switches, the nonconductive top layer comprising three apertures, wherein each button is aligned with one of the apertures.

8. The iontophoresis delivery system of claim 7, wherein one of the buttons is configured to activate the power switch so as to initiate or terminate an electrostimulation treatment, wherein one of the buttons is configured to activate an intensity adjustment switch configured to adjust an intensity of the electrostimulation up, and wherein one of the buttons is configured to activate an intensity adjustment switch configured to adjust an intensity of the electrostimulation down.

9. The iontophoresis delivery system of claim 8, wherein the intensity is adjusted by changing an amplitude or a frequency of a generated stimulation current.

10. The iontophoresis delivery system of claim 1, wherein the pulse generation circuitry is configured to apply AC TENS current in two directions between the first electrode and the second electrode, and wherein a waveform of the AC TENS current has no DC component so as not to transfer any therapeutic compound remaining in the first electrode reservoir after an iontophoretic treatment time has been reached.

11. The iontophoresis delivery system of claim 1, wherein the puncture connections are formed by pushing a pin, rod, or other rigid member through a conductive portion of the electronics layer to deform the conductive portion and form a hole surrounded by protrusions of the conductive material extending away from the electronics layer.

12. The iontophoresis delivery system of claim 11, wherein the protrusions are jagged and irregular.

13. The iontophoresis delivery system of claim 11, wherein a body of the conductive layer is pre-scored or otherwise prepared so that the protrusions are regularly spaced and sized.

14. The iontophoresis delivery system of claim 11, wherein the protrusions extend through the nonconductive layer and are bent to fold back against the first electrode to form an electrical connection between the conductive portion of the electronics layer and the first electrode.