LONG TERM WEAR MULTIFUNCTION BIOMEDICAL ELECTRODE

• US 20130325096A1
• Filed: 05/31/2013
• Published: 12/05/2013
• Est. Priority Date: 05/31/2012
• Status: Active Grant

• Current Assignee: Zoll Medical Corporation (Asahi Kasei Corporation)
• Original Assignee: Zoll Medical Corporation (Asahi Kasei Corporation)
• Inventors: Dupelle, Michael R., Totman, Mark, Desmarais, Christopher
• Granted Patent: US 9,737,701 B2
• Time in Patent Office: Days
• US Class Current: 607/142
• CPC Class Codes: A61B 2562/17 Comprising radiolucent components
• CPC Class Codes: A61B 5/259 using conductive adhesive means, e.g. gels
• CPC Class Codes: A61N 1/046 Specially adapted for shock therapy, e.g. defibrillation
• 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 1/0496 characterised by using specific chemical compositions, e.g. hydrogel compositions, adhesives

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.

Claims

1. An electrode comprising:

an adhesive film layer having a first surface and a second surface opposite the first surface;

a conductive element substantially surrounded by the adhesive film layer; and

a conductive gel layer covering at least a portion of a surface of the conductive element, the conductive element and the conductive gel layer having a combined impedance of less than about 3 Ohms, the conducting gel layer comprising a material that does not result 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.

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 conductive gel layer is formed from a hydrogel comprising 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

5. The electrode of claim 4, wherein R¹ 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 R¹ represents

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

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

9. An electrode patch comprising:

an adhesive film layer having a first surface and a second surface opposite the first surface; and

a plurality of electrodes, at least one of the plurality of electrodes including a conductive element substantially surrounded by the adhesive film layer, and a conductive gel layer covering at least a portion of a surface of the conductive element, the conductive element and the conductive gel layer having a combined impedance of less than about 3 Ohms, the conductive gel layer comprising a material that does not result 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.

10. The electrode patch of claim 9, 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.

11. The electrode patch of claim 10, wherein the conductive gel layer of at least one of the plurality of electrodes is a hydrogel comprising 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.

12. The electrode patch of claim 11, wherein the first monomer is a compound of the formula

13. The electrode patch of claim 12, wherein the second monomer is a compound of the formula

14. The electrode patch of claim 11, wherein a first of the plurality of electrodes and a second of the plurality of electrodes are spaced equidistant from a third of the plurality of electrodes.

15. The electrode patch of claim 11, wherein at least two of the plurality of electrodes share a common electrical connection.

16. The electrode of claim 11, wherein at least two of the plurality of electrodes can be selectively electrically coupled together.

17. A biomedical electrode system, comprising:

a first electrode configured to adhere to a first location of a subject; and

a second electrode configured to adhere to a second location of the subject;

the first electrode including;

an adhesive film layer having a first surface and a second surface opposite the first surface;

a conductive element substantially surrounded by the adhesive film layer; and

a conductive gel layer covering at least a portion of a surface of the conductive element, the conductive element and the conductive gel layer having a combined impedance of less than about 3 Ohms, the conductive gel layer comprising a material that does not result 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.

18. The biomedical electrode system of claim 17, wherein the conductive gel layer comprises a material that does not result 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 two weeks.

19. The biomedical electrode system of claim 17, wherein the conductive gel layer is a hydrogel comprising 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.

20. The biomedical electrode system of claim 19, wherein the first monomer is a compound of the formula

21. The biomedical electrode system of claim 20, wherein the second monomer is a compound of the formula

22. An electrode comprising:

an adhesive film layer having a first surface and a second surface opposite the first surface;

a conductive element substantially surrounded by the adhesive film layer; and

a conductive gel layer covering at least a portion of a surface of the conductive element, the conductive element and the conductive gel layer having a combined impedance of between about 30 Ohms to about 100 Ohms, the conducting gel layer comprising a material that does not result 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.