Disposable electro-dermal device

• US 5,865,741 A
• Filed: 01/16/1997
• Issued: 02/02/1999
• 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:
  US08/783,904
• Time in Patent Office: 747 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 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 flexible sheet 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 sheet which vary dependent on patient size, 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 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 2.00 inches±

0.56 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 said receptor positions form a fixed dimensional array.

8. The device of claim 1, wherein said receptor positions form a fixed array of openings.

9. An electro-dermal sensor positioning device comprising a flexible sheet 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 sheet which vary dependent on patient size, wherein

the distance between V₄ and V₅ and between V₅ and V₆ is about 1.75 inches.

10. An electro-dermal sensor positioning device comprising a flexible sheet 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 sheet which vary dependent on patient size, wherein

the distance between V₄ and V₅ and between V₅ and V₅ is about 2.5 inches.

11. An electro-dermal sensor positioning device comprising a flexible sheet 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 sheet which vary dependent on patient size, wherein

the distance between V₄ and V₅ and between V₅ and V₆ is about 3.5 inches.

12. An electro-dermal sensor positioning device comprising a flexible sheet 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 sheet which vary dependent on patient size, wherein

V₁ is located 2.00 inches±

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

13. The device of claim 12, wherein the device can be provided in three sizes, with the distance between V₄ and V₅ 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.

14. A plurality of electro-dermal sensor positioning devices of different sizes, with each device comprising:

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.

15. The devices of claim 14, wherein in each said 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 is substantially equidistant between V₄ and V₆.

16. The devices of claim 14, 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.

17. The devices of claim 14, wherein in each said device V₁ is located 2.00 inches±

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

18. The devices of claim 14, wherein in each said device V₃ is located on about a 125 degree radial from the center of V₂.

19. A method of fitting a patient with an electro-dermal sensor positioning device having a flexible sheet with 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 sheet which vary 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; and

selecting a sensor positioning device size based on the measured distance.

20. A method of fitting a patient according to claim 19, further comprising the step of selecting a sensor positioning 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".

21. A method of fitting a patient according to claim 19, further comprising the step of selecting a sensor positioning 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".

22. A method of fitting a patient according to claim 19, further comprising the step of selecting a sensor positioning 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".

23. A method of fitting a patient according to claim 19, wherein the selected sensor positioning device has a distance between V₁ and V₂ of 2.00 inches±

0.56 inches, and a distance between V₂ and V₄ of 3.5 inches±

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

24. A me thod according to claim 19, wherein the receptor positions V₁ and V₂ are positionable approximately on either side of the sternum at the fourth intercostal space and receptor position V₃ is positionable approximately midway between V₂ and V₄.

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

providing a flexible sheet 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 sheet;

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

positioning the receptor positions 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 substantially equidistant between V₄ and V₆.

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

27. A process according to claim 25, further comprising the step of positioning receptor postions 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.

28. 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.

29. 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.

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

31. A process according to claim 25, further comprising the step of providing an array of openings O₁ -O₆ at said receptor positions V₁ -V₆.

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

providing a flexible sheet 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 sheet; and

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

the fixed locations of receptor positions V₅ and V₆ are based on a measured distance between a midclvicular line and a midaxillary line on the chest of the patient.

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

providing a flexible sheet 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 sheet; and

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

the device can be provided in three sizes, with the distance between V₄ and V₅ 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.

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

providing a flexible sheet 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 sheet; and

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

V₁ is located 2.00 inches±

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