Disposable electrodeless electro-dermal devices

• US 6,066,093 A
• Filed: 01/16/1997
• Issued: 05/23/2000
• Est. Priority Date: 07/28/1995
• Status: Expired due to Term

• Current Assignee: Unilead International Incorporated
• Original Assignee: Unilead International Incorporated
• Inventors: Wenger, William K., Kelly, Robert J., Lavine, Thomas G.
• Primary Examiner(s): COHEN, LEE S
• Application Number:
  US08/783,912
• Time in Patent Office: 1,223 Days
• Field of Search: 600/372, 600/383, 600/386, 600/388, 600/389, 600/390, 600/391, 600/392, 600/393
• US Class Current: 600/386
• CPC Class Codes: A61B 5/282 Holders for multiple electrodes for introduction into the body A61B5/287

Abstract

A disposable electrodeless electro-dermal connector device includes a flexible non-conductive sheet having a fixed array of electrical conductor strips affixed thereon and positioned in a specific size configuration appropriate for electrocardiographic recording. The connector strips have a receptor pad end adapted for electrical connection with the skin for receiving electrical impulses and a terminal connection end which is adapted for connection with an electrocardiological measuring apparatus. Receptor pads V₁ and V₂ are attached approximately over the sternum at the fourth intercostal space and receptor pads V₃ and V₄ are attached over the ribs, with the distance between V₁ and V₂ being 2.00 inches ±0.56 inches, the distance between V₂ and V₄ being 3.5 inches ±1.00 inch.

Claims

1. A disposable electrodeless electro-dermal connector device comprising:

a flexible non-conductive sheet comprising a fixed array of electrical conductor strips affixed thereon and positioned in a specific size configuration appropriate for electrocardiographic recording, said conductor strips having receptor ends V₁ to V₆ adapted for electrical connection with the skin for receiving and transmitting electrical impulses and a terminal connection end which is adapted for connection with an electrocardiological measuring apparatus, with said receptor ends V₁, V₂, V₃ and V₄ positioned at predetermined fixed locations on said sheet and said receptor ends V₅ and V₆ positioned at predetermined fixed locations on said sheet which vary dependent on patient size.

2. The connector device of claim 1, wherein the distance between V₁ and V₂ is 2.00 inches ±

0.56 inches and the distance between V₂ and V₄ is 3.5 inches ±

1.00 inch, with V₃ located substantially midway between V₂ and V₄, and V₅ is equidistant between V₄ and V₆.

3. The connector device of claim 1, wherein said non-conductive sheet is selected from non-conductive flexible natural or synthetic sheet material.

4. The connector device of claim 3, wherein said non-conductive sheet is selected from cellulosic materials, polyesters, polyolefins, polyvinyl chloride or nylon.

5. The connector device of claim 4, wherein said cellulosic material is cotton or paper.

6. The connector device of claim 4, wherein said polyester is polyethylene terphthalate.

7. The connector device of claim 1, wherein the conductor strips are selected from metal, polymer, graphite or carbon fibers.

8. The connector device of claim 7, wherein said metal is selected from gold, copper, silver, tin or aluminum and alloys or mixtures thereof.

9. The connector device of claim 8, wherein said conductor strips are made of metal foil or a metal paste.

10. The connector device of claim 9, wherein said paste is printed or silk screened onto said non-conductive sheet.

11. The connector device of claim 10, wherein said paste is electrolessly deposited on said non-conductive sheet.

12. The connector device of claim 8, wherein said conductor strips are less than 10 microns in thickness.

13. The connector device of claim 7, wherein the conductive strips are coated with a dielectric polymeric material so that only sensitive portions are exposed.

14. The connector device of claim 13, wherein said polymeric material is selected from the group consisting of polyesters, copolymer of ethylene-vinyl acetate, homopolymers and copolymers of polyvinylchloride and ABS resin.

15. The connector device of claim 1, wherein the distance between V₄ and V₅ and between V₅ and V₆ is about 1.75 inches.

16. The connector device of claim 1, wherein the distance between V₄ and V₅ and between V₅ and V₆ is about 2.5 inches.

17. The connector device of claim 1, wherein the distance between V₄ and V₅ and between V₅ and V₆ is about 3.5 inches.

18. The connector device of claim 1, wherein V₁ is located 2.00 inches ±

0.56 inches in radius on about a 270 degree radial from the center of V₂.

19. The connector device of claim 1, wherein V₃ is located on about a 125 degree radial from the center of V₂.

20. A method of fitting a patient with an electrodeless electro-dermal connector device comprising a flexible non-conductive sheet comprised of a fixed array of electrical conductor strips affixed thereon and positioned in a specific size configuration appropriate for electrocardiographic recording, the conductor strips having receptor ends V₁ to V₆ adapted for electrical connection with the skin for receiving and transmitting electrical impulses and a terminal connection end which is adapted for connection with an electrocardiological measuring apparatus, with said receptor ends V₁, V₂, V₃ and V₄ positioned at predetermined fixed locations on said sheet and said receptor ends V₅ and V₆ positioned at predetermined fixed locations on said sheet dependent on patient size, said method comprising the steps of:

measuring the distance between a midclavicular line and a midaxillary line on the chest of the patient;

selecting a connector device with receptor ends V₅ and V₆ positioned at their predetermined fixed locations based on the measured distance; and

positioning the selected connector device on the patient.

21. A method of fitting a patient according to claim 20, further comprising the step of selecting a connector device with a distance of 1.75" between V₄ and V₅ and 1.75" between V₅ and V₆ when the measured distance is between 2.5" and 4.5".

22. A method of fitting a patient according to claim 20, further comprising the step of selecting a connector device with a distance of 2.5" between V₄ and V₅ and 2.5" between V₅ and V₆ when the measured distance is between 4.0" and 6.0".

23. A method of fitting a patient according to claim 20, further comprising the step of selecting a connector device with a distance of 3.5" between V₄ and V₅ and 3.5" between V₅ and V₆ when the measured distance is between 6.0 and 8.0".

24. A method of fitting a patient according to claim 20, wherein the distance between V₁ and V₂ is 2.00 inches ±

0.56 inches, and the distance between V₂ and V₄ is 3.5 inches ±

1.00 inch, with V₃ located substantially midway between V₂ and V₄, and V₅ is equidistant between V₄ and V₆.

25. A process of forming an electrodeless electro-dermal connector device, comprising the steps of:

providing a flexible sheet for supporting a fixed array of electrical conductor strips;

affixing an array of electrical conductor strips on the flexible sheet in a specific size configuration appropriate for electrocardiographic recording, with the conductor strips having receptor ends V₁ -V₆ adapted for electrical connection with the skin for receiving and transmitting electrical impulses and a terminal connection end which is adapted for connection with an electrocardiological measuring apparatus;

positioning the electrical conductor strips so that receptor ends V₁, V₂, V₃ and V₄ are disposed at predetermined fixed locations on the sheet; and

positioning the electrical conductor strips so that receptor ends V₅ and V₆ are disposed at predetermined fixed locations on the sheet which vary dependent on patient size.

26. A process according to claim 25, further comprising the step of positioning the receptor ends V₁ -V₆ such that the distance between V₁ and V₂ is 2.00 inches ±

0.56 inches, and the distance between V₂ and V₄ is 3.5 inches ±

1.00 inch, with V₃ located substantially midway between V₂ and V₄, and V₅ is equidistant between V₄ and V₆.

27. A process according to claim 25, further comprising the step of positioning receptor ends V₅ and V₆ based on a measured distance between a midclavicular line and a midaxillary line on the chest of the patient.

28. A process according to claim 25, further comprising the step of positioning receptor ends V₁ and V₂ to be approximately on either side of the sternum at the fourth intercostal space and positioning receptor end V₃ to be approximately midway between V₂ and V₄.

29. A process according to claim 25, wherein the distance between V₄ and V₅ and between V₅ and V₆ for a small size is about 1.75 inches, for a medium size is about 2.5 inches, and for a large size is about 3.5 inches.

30. A process according to claim 25, wherein V₁ is located 2.00 inches ±

0.56 inches in radius on about a 270 degree radial from the center of V₂.

31. A process according to claim 25, wherein V₃ is located on about a 125 degree radial from the center of V₂.

32. A plurality of electro-dermal connector devices of different sizes, with each device comprising:

a flexible non-conductive sheet comprising a fixed array of electrical conductor strips affixed thereon and positioned in a specific size configuration appropriate for electrocardiographic recording, said conductor strips having receptor ends V₁ to V₆ adapted for electrical connection with the skin for receiving and transmitting electrical impulses and a terminal connection end which is adapted for connection with an electrocardiological measuring apparatus, with the receptor ends V₁, V₂, V₃ and V₄ positioned at predetermined fixed locations on each said size, and receptor ends V₅ and V₆ positioned at predetermined fixed locations on each said size which vary dependent upon the size of the patient.

33. A plurality of electrodermal connector devices as set forth in claim 32, wherein on each device the distance between V₁ and V₂ is 2.00 inches ±

0.56 inches, and the distance between V₂ and V₄ is 3.5 inches ±

1.00 inch, with V₃ located substantially midway between V₂ and V₄, and V₅ being generally equidistant between V₄ and V₆.