Combined defibrillation and pacing electrode

• US 5,330,526 A
• Filed: 05/01/1992
• Issued: 07/19/1994
• Est. Priority Date: 05/01/1992
• Status: Expired due to Term

• Current Assignee: Zoll Medical Corporation (Asahi Kasei Corporation)
• Original Assignee: Zmd Corporation
• Inventors: Stutz, Rolf S., Fincke, Randall W.
• Primary Examiner(s): Kamm, William E.
• Assistant Examiner(s): Getzow, Scott M.
• Application Number:
  US07/877,838
• Time in Patent Office: 809 Days
• Field of Search: 128/639, 128/640, 128/798
• US Class Current: 607/142
• CPC Class Codes: A61N 1/046 Specially adapted for shock therapy, e.g. defibrillation
• CPC Class Codes: A61N 1/0496 characterised by using specific chemical compositions, e.g. hydrogel compositions, adhesives
• CPC Class Codes: A61N 1/3625 External stimulators
• CPC Class Codes: A61N 1/3904 External heart defibrillators [EHD]

Abstract

An electrode for transcutaneously delivering defibrillation pulses to a patient'"'"'s heart. The electrode comprises an insulating substrate, a conducting plate which is positioned on the substrate and which has an electrical terminal for making a connection to an external source of electrical current, and a layer of electrolytic gel covering the entire top surface of the conducting plate. This gel contacts a patient'"'"'s skin when the electrode is positioned on the skin to prevent the conducting plate from contacting the skin. The gel comprises a concentration of an electrolyte such that the combination series resistance of two of the electrodes, when measured with the electrodes configured in a series circuit with a 50 Ω resistance, and with the electrolytic gel layer of each electrode in contact with that of the other electrode, is greater than 1 Ω when a 200 Joule defibrillation pulse is discharged into the series circuit.

Claims

1. An electrode for transcutaneously delivering defibrillation pulses to a patient'"'"'s heart, the electrode comprising:

an insulating substrate,

a conducting plate having a top surface, a bottom surface, and an electrical terminal for making a connection to an external source of electrical current, said conducting plate being positioned with said bottom surface on said substrate, and

a layer of electrolytic gel comprising a concentration of an electrolyte that produces a combination series resistance of two of said electrodes, when measured with the electrodes configured in a series circuit with a 50 Ω

resistance, and with the electrolytic gel layer of each electrode in contact with that of the other electrode, that is greater than 1 Ω

when a 200 Joule defibrillation pulse is discharged into the series circuit, said layer of electrolytic gel covering the entire top surface of said conducting plate, the gel contacting a patient'"'"'s skin when the electrode is positioned on the patient'"'"'s skin to thereby prevent said conducting plate from contacting the patient'"'"'s skin.

2. The electrode of claim 1 wherein said combination series resistance is at least 1.5 Ω

.

3. The electrode of claim 2 wherein said combination series resistance is not more than 5 Ω

.

4. The electrode of claim 3 wherein said combination series resistance is not more than 3 Ω

.

5. The electrode of claim 1 wherein said combination series resistance is at least 5 Ω

.

6. The electrode of claim 1 wherein said combination series resistance is such that the energy of said defibrillation pulse discharged into said series circuit delivered to said 50 Ω

resistance is within 30 Joules of the 200 Joule defibrillation pulse.

7. The electrode of claim 6 wherein said combination series resistance is such that the energy of said defibrillation pulse discharged into said series circuit delivered to said 50 Ω

resistor is within 20 Joules of the 200 Joule defibrillation pulse.

8. The electrode of claim 1 wherein said electrode conducting plate occupies a general region having an area that is greater than the surface area of the electrode conducting plate and a perimeter that is less than the perimeter of the electrode conducting plate.

9. The electrode of claim 8 wherein said electrode is intended to be disposed of after use.

10. The electrode of claim 9 further comprising a removable insulating cover which when positioned on the electrode entirely covers the electrolytic gel layer, the cover designed to be removed from the electrode prior to use of the electrode.

11. The electrode of claim 1 wherein said electrolyte is a salt.

12. The electrode of claim 11 wherein said salt is sodium chloride.

13. The electrode of claim 12 wherein said layer of electrolytic gel is supported by a layer of foam covering the entire top surface of said conducting plate so that said foam contacts said patient'"'"'s skin when the electrode is positioned on the skin, the foam being soaked with said electrolytic gel.

14. The electrode of claim 13 wherein said foam layer is at least 3/16 inch-thick.

15. The electrode of claims 1 or 14 wherein a portion of the substrate extending beyond the area of the conducting plate includes adhesive for temporarily affixing the electrode to a patient'"'"'s skin.

16. The electrode of claim 15 wherein said adhesive comprises a medical grade acrylic adhesive.

17. The electrode of claim 15 wherein the area of the substrate extending beyond the area of the conducting plate comprises a boarder layer of flexible foam positioned on top of said substrate and encircling said conducting plate.

18. The electrode of claim 17 wherein the top surface of said border layer is coated with said adhesive for temporarily affixing the electrode to a patient'"'"'s skin.

19. The electrode of claim 1 wherein said substrate has an area larger than the area of the conducting plate.

20. The electrode of claim 19 wherein said insulating substrate comprises a layer of flexible foam at least 1.8 inches-thick.

21. The electrode of claim 1 wherein the conductivity of said electrolytic gel is less than or equal to the conductivity of a gel comprising a sodium chloride concentration of 4.7% weight per volume of the gel.

22. The electrode of claim 21 wherein the conductivity of said electrolytic gel is less than or equal to the conductivity of a gel comprising a sodium chloride concentration of 1.5% weight per volume of the gel.

23. The electrode of claim 22 wherein said electrolytic gel is a water-based polymer gel.

24. A set of electrodes, each of said electrodes comprising:

an insulating substrate,

a conducting plate having a top surface, a bottom surface, and an electrical terminal for making a connection to an external source of electrical current, said conducting plate being positioned with said bottom surface on said substrate, and

a layer of electrolytic gel comprising a concentration of an electrolyte that produces a combination series resistance of two of said electrodes, when measured with the electrodes configured in a series circuit with a 50 Ω

resistance, and with the electrolytic gel layer of each electrode in contact with that of the other electrode, that is greater than 1 Ω

when a 200 Joule defibrillation pulse is discharged into the series circuit, said layer of electrolytic gel covering the entire top surface of said conducting plate, the gel contacting said patient'"'"'s skin when the electrode is positioned on the patient'"'"'s skin to thereby prevent said conducting plate from contacting the skin,

said set of electrodes comprising a front electrode to be positioned on the front of a patient'"'"'s chest and a back electrode to be positioned on the back of a patient'"'"'s chest, the conducting plate of the front electrode having an area of at least 8 square inches and the conducting plate of the back electrode having an area of at least 8 square inches.

25. The set of electrodes of claim 24 wherein the shape of the perimeter of each of said electrode conducting plates is such that each said electrode conducting plate occupies a general region having an area that is greater than the surface area of the electrode conducting plate and a perimeter that is less than the perimeter of the electrode conducting plate.

26. The electrode of claim 25 wherein said front set of electrodes conducting plate occupies a generally circular region and said back electrode conducting plate occupies a generally rectangular region.

27. The electrode of claim 24 wherein said front set of electrodes conducting plate and said back electrode conducting plate each comprises a continuous geometry including inwardly extending excursions of the perimeter of said geometry at spaced intervals around the perimeter of said geometry.

28. The set of electrodes of claim 27 wherein each of said inward perimeter excursions extends into said geometry a distance of at least one fifth of the transverse dimension of said plate in the direction of said excursion.

29. The set of electrodes of claim 24 wherein said layer of gel of the front electrode has an area of at least 8 square inches and said layer of gel of the back electrode has an area of at least 8 square inches.

30. The set of electrodes of claim 29 wherein each of said layers of gel occupies a general region having an area that is greater than the surface area of the layer of gel and a perimeter that is less than the perimeter of the layer of gel.

31. The set of electrodes of claim 30 wherein said insulating substrate of said front electrode and said insulating substrate of said back electrode each has an area of at least 8 square inches.

32. A method of transcutaneously defibrillating a patient'"'"'s heart, the method comprising the steps of:

generating an electrical defibrillation pulse, and

delivering said pulse to said patient through electrodes applied to said patient'"'"'s thorax, the electrodes each comprising;

an insulating substrate,

a conducting plate having a top surface, a bottom surface, and an electrical terminal for making a connection to receive said electrical defibrillation pulse, said conducting plate being positioned with said bottom surface on said substrate, and

a layer of electrolytic gel comprising a concentration of an electrolyte that produces a combination series resistance of two of said electrodes, when measured with the electrodes configured in a series circuit with a 50 Ω

resistance, and with the electrolytic gel layer of each electrode in contact with that of the other electrode, that is greater than 1 Ω

when a 200 Joule defibrillation pulse is discharged into the series circuit, said layer of electrolytic gel covering the entire top surface of said conducting plate, the gel contacting a patient'"'"'s skin when the electrode is positioned on the patient'"'"'s skin to thereby prevent said conducting plate from contacting the patient'"'"'s skin.

33. The method of claim 32 further comprising the steps of:

generating electrical pacing stimuli, and

transcutaneously delivering said electrical pacing stimuli to said patient'"'"'s heart through said electrodes applied to said patient'"'"'s thorax.

34. The method of claim 32 wherein said defibrillation pulse has an energy between 200 and 400 Joules.

35. The method of claim 32 wherein the difference between the energy of said defibrillation pulse delivered to said patient and the total energy of said defibrillation pulse is less than or equal to the larger of 10% of the total energy of said defibrillation pulse or 4 Joules.

36. The method of claim 35 wherein said difference is less than or equal to 10% of the total energy of said defibrillation pulse.

37. The method of claim 32 wherein said combination series resistance is at least 1.5 Ω

.

38. The method of claim 37 wherein said combination series resistance is at least 5 Ω

.

39. The method of claim 37 wherein said combination series resistance is not more than 5 Ω

.

40. The method of claim 39 wherein said combination series resistance is not more than 3 Ω

.

41. The method of claim 32 wherein the energy of said defibrillation pulse discharged into said series circuit delivered to said 50 Ω

resistor is within 30 Joules of the 200 Joule defibrillation pulse.

42. The method of claim 41 wherein the energy of said defibrillation pulse discharged into said series circuit delivered to said 50 Ω

resistor is within 20 Joules of the 200 Joule defibrillation pulse.