Long term wear multifunction biomedical electrode

Patent metadata

Field	Value
Publication number	US-9737701-B2
Application number	US-201313907268-A
Country	US
Kind code	B2
Filing date	May 31, 2013
Priority date	May 31, 2012
Publication date	Aug 22, 2017
Grant date	Aug 22, 2017

Abstract

Electrodes, multi-electrode patches, and electrodes for biomedical systems are provided. The electrode includes an adhesive film layer having a top surface and a bottom surface. A conductive element is substantially surrounded by the adhesive film layer. A conductive gel layer covers at least portion of a surface of the conductive element. The conducting gel comprises a material that does not result in significant skin irritation on a human subject after a period of at least about one week.

First claim

What is claimed is:

1. An electrode comprising:
a conductive element; and
a hydrogel covering at least a portion of a surface of the conductive element, the conductive element and the hydrogel having a combined AC large signal impedance of about 1 Ohm to about 3 Ohms as tested in accordance with the method of the ANSI/AAMI DF80: 2003 medical electrical equipment standard for the safety of cardiac defibrillators, the hydrogel not resulting in significant skin irritation on a human subject as tested in accordance with the method of ANSI/AAMI/ISO standard 10993-1 after a period of at least about one week,
the electrode being disposed in an electrode patch, the electrode patch comprising an adhesive film layer configured to substantially surround the conductive element and adhere to skin of the subject, the electrode being laterally movable in a plane of the electrode patch and relative to one or more other electrodes disposed in the electrode patch.

2. The electrode of claim 1 , wherein the electrode provides similar electrical performance during defibrillation as an electrode compliant with the ANSI/AAMI DF80:2003 medical electrical equipment standard for the safety of cardiac defibrillators.

3. The electrode of claim 2 , wherein the hydrogel comprises an aqueous plasticizer, a copolymer of a hydrophilic unsaturated water-soluble first monomer, a hydrophilic unsaturated water-soluble second monomer, and a cross-linking agent.

4. The electrode of claim 3 , wherein the first monomer is a compound of the formula

wherein R 1 is selected from the group consisting of a hydrocarbon moiety, a hydroxyl group, an amino group, an ammonium group, a halogen, and an alkali metal cation, R 2 is selected from the group consisting of hydrogen, a methyl group, an ethyl group, a hydroxyl group, an amino group, an ammonium group, a halogen, and an alkali metal cation, and M is selected from the group consisting of hydrogen and a cation.

5. The electrode of claim 4 , wherein R 1 is selected from the group consisting of alkyl, cycloalkyl, and an aromatic moiety containing from 3 to 12 carbon atoms.

6. The electrode of claim 4 , wherein R 1 represents

wherein R 3 is selected from the group consisting of hydrogen, an alkyl group possessing from 1 to 6 carbon atoms, a hydroxyl group, an amino group, an ammonium group, a halogen, and an alkali metal cation, and R 4 is selected from the group consisting of an alkyl group possessing from 1 to 6 carbon atoms, a hydroxyl group, an amino group, an ammonium group, a halogen, and an alkali metal cation.

7. The electrode of claim 6 , wherein the second monomer is a compound of the formula

wherein R 5 is selected from the group consisting of hydrogen, a methyl group, an ethyl group, a hydroxyl group, an amino group, an ammonium group, a halogen, and an alkali metal cation, and R 6 is selected from the group consisting of hydrogen, a cation, and R 7 SO 3 , wherein R 7 is selected from the group consisting of an alkylene moiety of 1 to 4 carbon atoms, a hydroxyl group, an amino group, an ammonium group, a halogen, and an alkali metal cation.

8. The electrode of claim 4 , wherein the second monomer is a compound of the formula

wherein R 5 is selected from the group consisting of hydrogen, a methyl group, an ethyl group, a hydroxyl group, an amino group, an ammonium group, a halogen, and an alkali metal cation, and R 6 is selected from the group consisting of hydrogen, a cation, and R 7 SO 3 , wherein R 7 is selected from the group consisting of an alkylene moiety of 1 to 4 carbon atoms, a hydroxyl group, an amino group, an ammonium group, a halogen, and an alkali metal cation.

9. The electrode of claim 1 , wherein the electrode is coupled to an electrical conductor that allows the electrode to move relative to the electrode patch.

10. The electrode of claim 9 , wherein the electrical conductor is formed with a zig-zag shape.

11. The electrode of claim 1 , wherein each of the electrodes disposed in the electrode patch are laterally movable in the plane of the electrode patch relative to each other of the electrodes disposed in the electrode patch.

12. An electrode patch comprising:
an adhesive film layer having a first surface and a second surface opposite the first surface, the second surface configured to adhere to skin of a subject; and
a plurality of electrodes disposed in the electrode patch, at least one of the plurality of electrodes including a conductive element substantially surrounded by the adhesive film layer, and a hydrogel covering at least a portion of a surface of the conductive element, the conductive element contacting the hydrogel through an aperture in the adhesive film layer, the conductive element and the hydrogel having a combined AC large signal impedance of about 1 Ohm to about 3 Ohms as tested in accordance with the method of the ANSI/AAMI DF80: 2003 medical electrical equipment standard for the safety of cardiac defibrillators, the hydrogel not resulting in significant skin irritation on a human subject as tested in accordance with the method of ANSI/AAMI/ISO standard 10993-1 after a period of at least about one week, the at least one of the plurality of electrodes being laterally movable in a plane of the electrode patch and relative to one or more other of the plurality of electrodes disposed in the electrode patch.

13. The electrode patch of claim 12 , wherein the electrode patch provides similar electrical performance during defibrillation as an electrode compliant with the ANSI/AAMI DF80:2003 medical electrical equipment standard for the safety of cardiac defibrillators.

14. The electrode patch of claim 13 , wherein the hydrogel comprises an aqueous plasticizer, a copolymer of a hydrophilic unsaturated water-soluble first monomer, a hydrophilic unsaturated water-soluble second monomer, and a cross-linking agent.

15. The electrode patch of claim 14 , wherein the first monomer is a compound of the formula

wherein R 1 is selected from the group consisting of a hydrocarbon moiety, a hydroxyl group, an amino group, an ammonium group, a halogen, and an alkali metal cation, R 2 is selected from the group consisting of hydrogen, a methyl group, an ethyl group, a hydroxyl group, an amino group, an ammonium group, a halogen, and an alkali metal cation, and M is selected from the group consisting of hydrogen and a cation.

16. The electrode patch of claim 15 , wherein the second monomer is a compound of the formula

wherein R 5 is selected from the group consisting of hydrogen, a methyl group, an ethyl group, a hydroxyl group, an amino group, an ammonium group, a halogen, and an alkali metal cation, and R 6 is selected from the group consisting of hydrogen, a cation, and R 7 SO 3 , wherein R 7 is selected from the group consisting of an alkylene moiety of 1 to 4 carbon atoms, a hydroxyl group, an amino group, an ammonium group, a halogen, and an alkali metal cation.

17. The elec

Assignees

• Zoll Medical Corp

Inventors

• Dupelle Michael R
• Desmarais Christopher
• Totman Mark

Classifications

• A61N1/0496 Primary

  characterised by using specific chemical compositions, e.g. hydrogel compositions, adhesives · CPC title

• A61N1/0476

  Array electrodes (including any electrode arrangement with more than one electrode for at least one of the polarities) · CPC title

• A61B5/04087

  Human Necessities · mapped topic

• A61N1/046

  Specially adapted for shock therapy, e.g. defibrillation · CPC title

• A61B2562/17

  Comprising radiolucent components · CPC title