Electrodermal positioning device and process of making same

• US 6,157,851 A
• Filed: 11/05/1998
• Issued: 12/05/2000
• 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.
• Primary Examiner(s): COHEN, LEE S
• Application Number:
  US09/186,161
• Time in Patent Office: 761 Days
• Field of Search: 600/372, 600/383, 600/386, 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 template has a flexible sheet with a fixed dimensional array V₁ -V₆ positioned in a specific size configuration appropriate for standard electrocardiographic recording. 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.

Claims

1. An electro-dermal sensor positioning device comprising a substrate having a fixed array V₁ -V₆ of receptor positions positioned in a specific size configuration appropriate for electrocardiographic recording, with said receptor positions V₁, V₂, V₃ and V₄ positioned at predetermined fixed locations on said sheet and said receptor positions V₅ and V₆ positioned at predetermined fixed locations on said substrate which vary dependent on patient size, wherein:

the distance between V₁ and V₂ is approximately 1.50 to 2.50 inches and the distance between V₂ and V₄ is approximately 2.50 to 4.50 inches, with V₃ located substantially midway between V₂ and V₄, and V₅ being substantially equidistant between V₄ and V₆.

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

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

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

5. The device of claim 1, wherein V₁ is located approximately 1.50 to 2.50 inches in radius on about a 270 degree radial from the center of V₂.

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

7. The device of claim 1, wherein V₄ is located on about a 125 degree radial from the center of V₂.

8. A device according to claim 1, wherein the distance between V₂ and V₄ ranges between 2 and 4.5 inches.

9. A device according to claim 1, wherein a vertical distance between V₂ and V₄ is approximately 2.5 to 3.5 inches.

10. A positioning device of claim 1, wherein said substrate is disposable.

11. The device of claim 1, wherein V₅ and V₆ can be positioned at three different locations on the substrate.

12. The device of claim 1, wherein said substrate is selected from nonconductive flexible natural or synthetic material.

13. The device of claim 12, wherein said substrate is selected from cellulosic materials, polyesters, polyolefins, polyvinyl chloride or nylon.

14. The device of claim 13, wherein said cellulosic material is cotton or paper.

15. The device of claim 13, wherein said polyester is polyethylene terphthalate.

16. A process of forming an electro-dermal sensor positioning device for electrocardiographic recording, comprising the steps of:

providing a substrate with a fixed array V₁ -V₆ of receptor positions positioned in a specific size configuration appropriate for electrocardiographic recording;

positioning receptor positions V₁, V₂, V₃ and V₄ at predetermined locations on the substrate;

positioning receptor positions V₅ and V₆ at fixed locations on the substrate which vary dependent on patient size; and

positioning the receptor positions V₁ -V₆ such that the distance between V₁ and V₂ is approximately 1.50 to 2.50 inches, and the distance between V₂ and V₄ is approximately 2.50 to 4.50 inches, with V₃ located substantially midway between V₂ and V₄, and V₅ substantially equidistant between V₄ and V₆.

17. A process according to claim 16, further comprising the step of positioning receptor positions V₅ and V₆ based on a distance between a midclavicular line and a midaxillary line on the chest of the patient.

18. A process according to claim 16, further comprising the step of positioning receptor positions V₁ and V₂ to be approximately on either side of the sternum at the fourth intercostal space and positioning array V₃ to be approximately midway between V₂ and V₄.

19. A process according to claim 16, 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.

20. A process according to claim 16, wherein V₁ is located approximately between 1.50-2.50 inches in radius on about a 270 degree radial from the center of V₂.

21. A process according to claim 16, wherein V₃ is located on about a 125 degree radial from the center of V₂.

22. A process according to claim 16, wherein V₄ is located on about a 125 degree radial from the center of V₂.

23. A process according to claim 16, further comprising the step of providing a disposable substrate.

24. The process of claim 16, wherein V₅ and V₆ can be positioned at three different locations on the substrate.

25. A plurality of sensor positioning devices of different sizes, with each device comprising:

a substrate with a fixed array V₁ -V₆ of receptor positions positioned in a specific size configuration appropriate for electrocardiographic recording, with the receptor positions V₁, V₂, V₃ and V₄ positioned at substantially the same locations on each said size, and receptor positions V₅ and V₆ positioned differently on each said size dependent upon the size of the patient.

26. The devices of claim 25, wherein in each said device the distance between V₁ and V₂ is approximately 1.50 and 2.50 inches and the distance between V₂ and V₄ is approximately 2.50 and 4.50 inches, with V₃ located substantially midway between V₂ and V₄, and V₅ is substantially equidistant between V₄ and V₆.

27. A device according to claim 26, wherein a vertical distance between V₂ and V₄ is approximately 2.0 to 3.5 inches.

28. The devices of claim 25, wherein three sizes of said devices are provided, with the distance between V₄ and V₅ and between V₅ and V₆ for a small size being about 1.75 inches, for a medium size being about 2.5 inches, and for a large size being about 3.5 inches.

29. The devices of claim 25, wherein in each said device V₁ is located approximately between 1.50 and 2.50 inches in radius on about a 270 degree radial from the center of V₂.

30. The devices of claim 25, wherein in each said device V₃ is located on about a 125 degree radial from the center of V₂.

31. The devices of claim 25, wherein in each said device V₄ is located on about a 125 degree radial from the center of V₂.

32. The device of claim 25, wherein said substrate is disposable.

33. An electro-dermal sensor positioning device comprising a flexible substrate having a fixed array V₁ -V₆ of receptor positions positioned in a specific size configuration appropriate for electrocardiographic recording, with said receptor positions V₁, V₂, V₃ and V₄ positioned at predetermined fixed locations on said substrate and said receptor positions V₅ and V₆ positioned at predetermined fixed locations on said substrate which vary dependent on patient size, wherein:

V₁ is located approximately between 1.50 and 2.50 inches in radius on about a 270 degree radial from the center of V₂.

34. The device of claim 33, wherein said substrate is disposable.

35. The device of claim 33, wherein said substrate is selected from nonconductive flexible natural or synthetic material.

36. The device of claim 35, wherein said substrate is selected from cellulosic materials, polyesters, polyolefins, polyvinyl chloride or nylon.

37. The device of claim 36, wherein said cellulosic material is cotton or paper.

38. The device of claim 36, wherein said polyester is polyethylene terphthalate.

39. A process of forming an electro-dermal sensor positioning device for electrocardiographic recording, comprising the steps of:

providing a substrate with a fixed array V₁ -V₆ of receptor positions positioned in a specific size configuration appropriate for electrocardiographic recording;

positioning receptor positions V₁, V₂, V₃ and V₄ at predetermined locations on the substrate; and

positioning receptor positions V₅ and V₆ at fixed locations on the sheet which vary dependent on patient size, wherein

V₁ is located approximately between 1.50 and 2.50 inches in radius on about a 270 degree radial from the center of V₂.

40. A process of claim 39, further comprising the step of providing a disposable substrate.

41. A process of forming a plurality of sensor positioning devices of different sizes, comprising the steps of:

providing a plurality of flexible substrates, each with a fixed array V₁ -V₆ of receptor positions positioned in a specific size configuration appropriate for electrocardiographic recording;

positioning receptor positions V₁, V₂, V₃ and V₄ at substantially the same locations on each size substrate; and

positioning receptor positions V₅ and V₆ differently on each size substrate dependent upon the size of the patient.

42. A process according to claim 41, further comprising the step of positioning receptor positions V₁ -V₆ on each size substrate, 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 substantially equidistant between V₄ and V₆.

43. A process according to claim 41, wherein the receptor positions V₅ and V₆ are positioned at fixed locations based on a measured distance between a midclavicular line and a midaxillary line on the chest of the patient, with the fixed locations varying for each size substrate.

44. A process according to claim 41, further comprising the step of, on each size substrate, positioning receptor positions V₁ and V₂ to be approximately on either side of the sternum at the fourth intercostal space and positioning V₃ to be approximately midway between V₂ and V₄.

45. A process according to claim 41, wherein three electro-dermal sensor positioning devices are formed, with the distance between V₄ and V₆ and between V₅ and V₆ for a small size device being about 1.75 inches, for a medium size device being about 2.5 inches, and for a large size device being about 3.5 inches.

46. A process according to claim 41, wherein V₁ on each size substrate is located 2.00 inches±

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

47. A process according to claim 41, wherein V₃ and V₄ on each size substrate are located on about a 125 degree radial from the center of V₂.

48. A process of claim 41, further comprising the steps of providing a plurality of disposable substrates.