Flexible and disposable electrode belt device

• US 4,763,660 A
• Filed: 03/13/1987
• Issued: 08/16/1988
• Est. Priority Date: 12/10/1985
• Status: Expired due to Fees

• Current Assignee: Aurora Capital Management LLC
• Original Assignee: Cherne Industries Incorporated (CRWS, Inc.)
• Inventors: Kroll, Mark W., Pommrehn, Mark R., Hanson, Dan
• Primary Examiner(s): Cohen, Lee S.
• Application Number:
  US07/024,919
• Time in Patent Office: 522 Days
• Field of Search: 128/639-641, 128/644, 128/798, 128/802, 128/803, 339/17 F, 439/77
• US Class Current: 600/391
• CPC Class Codes: A61B 5/259 using conductive adhesive means, e.g. gels
• CPC Class Codes: A61B 5/282 Holders for multiple electrodes for introduction into the body A61B5/287
• CPC Class Codes: A61N 1/22 Electromedical belts , e.g. neck chains, armbands
• CPC Class Codes: A61N 1/321 Electromedical belts

Abstract

The unitary flexible and disposable electrode belt and method is for receiving and transmitting electric current or voltage for use on the body of a patient. The belt has a unitary layered body structure that is releasably secured to the patient. The belt device body structure has a terminal end that is connectable for communication with medical therapeutic and diagnostic apparatus. The layered body structure further includes a plurality of flexible non-conductive and conductive layers, a conductive network having electrode contact areas at predetermined positions and conductive adhesive members to removably hold the device to a patient and to, thereby, transfer electrical signals between predetermined patient body locations and the medical therapeutic and diagnostic apparatus.

Claims

1. A unitary, disposable and flexible belt device for the releasable securement to the body of a patient and for receiving and transmitting electric current and voltage, said device having a composite and layered body structure with a terminal end and being connectable for use with a cable set of medical therapeutic and diagnostic apparatus, said composite and layered body structure further comprising:

a. a flexible non-conductive base structure layer for supporting and insulating the remaining elements of said composite and layered body structure,

b. a flexible conduction network affixed to said non-conductive base layer having a plurality of predetermined contact areas for receiving and transmitting electrical signals and a signal distribution system extending from said contact areas to the terminal end of the device, said signal distribution system and said contact areas of said flexible conduction network being comprised of a flexibly planar homogeneous layer of conductive material deposited on said base structure by a printing process,

c. a flexible inner non-conductive insulation layer affixed and coextensively disposed to said non-conductive base layer for insulating said signal distribution system from the body of a patient, said inner non-conductive layer further having a plurality of predetermined apertures exposing said conduction network contact areas, and having a void area at said terminal end exposing said signal distribution system, and

d. flexible conductive adhesive members affixed and coextensively disposed at each said plurality of predetermined apertures of said inner insulation layer for contact with said contact areas and the body of a patient to transfer electrical signals therebetween and for holding said device to the patient.

2. The device of claim 1, wherein a conductive shielding layer is generally coextensively affixed to said non-conductive base layer for reducing interference with and from the remaining elements of said body structure and for the electrical grounding of said device.

3. The device of claim 2, wherein said non-conductive base structure layer has at its terminal end a void exposing a portion of said conductive shielding layer for grounding purposes.

4. The device of claim 2, wherein said contact areas are of a predetermined size and further act in concert with said non-conductive base layer and said shielding layer to form a bypass capacitor to shunt high frequency interference to ground.

5. The device of claim 2, wherein said shielding layer is peripherally recessed with respect to said base structure layer to minimize the risk of shorting and patient shock due to device or medical diagnostic and therapeutic apparatus malfunction.

6. The device of claim 2, wherein an outer non-conductive insulation layer is affixed to said shielding layer.

7. The device of claim 2, wherein at least one additional shielding layer is generally coextensively affixed to said shielding layer closest said base structure layer to further shield said device from high frequency interference, said shielding layer and said additional shielding layer having a non-conductive separation layer affixed therebetween.

8. The device of claim 1, wherein said conductive adhesive members are extended and further affixed to one another thereby forming a single, homogeneous conductive and adhesive layer being generally coextensive with said inner insulation layer and said plurality of predetermined apertures of said inner insulation layer.

9. The device of claim 8, wherein said conductive, adhesive layer additionally has a release layer generally coextensively interposed between it and said inner insulation layer, said release layer further having the same said predetermined apertures at locations as said predetermined apertures of said inner insulation layer and further having a tab extending therefrom for allowing said conductive, adhesive layer and said release layer to be removed from the remaining elements of said device.

10. The device of claim 1, wherein said body structure has separable side portions defined by separation means disposed at predetermined longitudinally extending locations, said separation means disposed within and between said conduction network whereby one or more contact areas within said separable side portions are extendable outwardly from said body structure while retaining communication with said terminal end by said signal distribution system.

11. The device of claim 1, wherein said composite and layered body structure has a pair of translayer apertures therethrough to allow for breast protrusion when said device is positioned on the precordial region of a female patient.

12. The device of claim 1, wherein said composite, layered body structure has anatomical placement reference means being disposed therein to coordinate said contact areas relative to predetermined locations on the body of a patient.

13. The device of claim 1, wherein the body structure is rectilinear and wherein said predetermined contact areas are arranged having one at each corner of the body structure and six centrally placed in the body structure to form a generally curvilinear pattern whereby said contact areas conform with standard precordial positions for "twelve-lead" electrocardiographic devices.

14. The device of claim 1, wherein said predetermined contact areas are comprised of a thin rectilinear grid configuration.

15. The device of claim 1, wherein said non-conductive base layer and said inner insulation layer are comprised of a polyester laminated material.

16. The device of claim 1, wherein said terminal end is communicatively connectable to a multi-conductive cable set of a medical diagnostic or therapeutic apparatus, said terminal end having a passive polarization means for operator identification purposes and having an active polarization means to ensure proper alignment of said terminal end for mating communication with the cable set.

17. The device of claim 1, wherein said device additionally has a flexible coextensive liner releasably affixed in surface to surface engagement to said conductive adhesive members.

18. The device of claim 1, wherein said signal distribution network is comprised of a conductive material having a predetermined conductivity to provide a current limiter through said signal distribution system.

19. A flexible, disposable electrode belt for placement on the body of a patient to receive and transmit electric current and voltage and being for use with medical diagnostic and therapeutic apparatus, said flexible and disposable electrode belt comprising:

(a) a unitary, composite and layered main body structure with means to partially separate at least one peripheral side portion therefrom and having a terminal and a proximal end, said main body structure further having;

(1) a non-conductive base support layer for insulation of and supporting the remaining elements of said main body,

(2) a plurality of conductive electrodes affixed at predetermined locations on said proximal end of said non-conductive base support layer, said electrodes further having integral, elongated conductive lead strips in communication with each said electrode and being extended to the terminal end of said main body structure,

(3) a non-conductive inner patient insulation layer affixed to and coextensive with said non-conductive base support layer and having a plurality of apertures at locations corresponding to said predetermined electrode locations and having a void at its terminal end exposing said lead strips for communicating contact, and

(4) conductive, adhesive gel pads adhesively disposed to and being coextensive with each said aperture in said inner patient insulation layer for making contact with said electrodes and the body of a patient and for holding said device to the body of a patient; and

(b) at least one adjustable and extendible side member defined by said separation means of said main body structure for receiving and transmitting electric current and voltage at locations outside said main body structure and having an electrode and a communicating lead strip to said terminal end of said main body structure.

20. A flexible and unitary device of a layered construction for securement to the body of a patient to receive and transmit electric current and voltage and being for use with medical therapeutic or diagnostic apparatuses comprising:

a. a reusable, composite and layered main structure having a terminal end for mating communication with the medical apparatus, said main structure further having;

23. The device of claim 20, wherein said conductive adhesive layer of said patient interface structure additionally is provided with a release liner, said patient interface structure release layer further having a tab extending therefrom for allowing said conductive adhesive material layer and said release layer to be removed independently from the remaining elements of said device.

26. The method of claim 23, wherein said electrode belt device is further provided with a belt device structure wherein said adhesive conductive members are removable and disposable from the remaining elements of said device whereby subsequent to the removal of said device from the patient body only said adhesive conductive members are disposed of and the remainder of said device is reusable.

27. The method of claim 23, wherein a second electrode belt device is simultaneously used, one said device being disposed on the precordial region of the body of the patient and said second device on the dorsal surface of the patient.

28. The method of claim 23, wherein said selection of patient body locations is made to coincide with standard precordial locations for "twelve-lead" electrocardiographic applications.

21. a non-conductive base layer for insulation of an supporting the remaining elements of said main structure,a conduction network affixed to said base layer having a plurality of predetermined contact areas for reception and transmission of electrical signals from and to the body of a patient and a signal distribution system extending from said contact areas to said terminal end,an inner non-conductive layer affixed and coextensively disposed to said base layer for insulation of said signal distribution system from the body of a patient and having a plurality of predetermined apertures exposing said contact areas, and further having a void at said terminal end exposing said signal distribution system for communicating contact;

and

b. a disposable, composite and layered patient interface structure for coextensive mating communication with said main structure and having;

1. a non-conductive main structure release layer having a plurality of predetermined apertures being located at positions corresponding with said predetermined apertures of said main structure inner non-conductive layer for communicating with said contact areas of said main structure, and

22. a conductive adhesive layer coextensively disposed to said non-conductive main structure release layer for communicative contact with and between said contact areas of said main structure and the body of a patient and for releasably holding said patient interface structure to said main structure and to the body of a patient.

24. A unitary, disposable and flexible belt device for the releaseable securement to the body of a patient and for receiving and transmitting electric current and voltage, said device having a composite and layered body structure with a terminal end and being connectable for use with a cable set of medical therapeutic and diagnostic apparatus, said composite and layered body structure further comprising:

a. a non-conductive base structure layer for supporting and insulating the remaining elements of said composite and layered body structure,

b. a conduction network affixed to said non-conductive base layer having a plurality of predetermined contact areas for receiving and transmitting electrical signals and a signal distribution system extending from said contact areas to the terminal end of the device, each said contact area further having a predetermined area dimension,

c. an inner non-conductive insulation layer affixed and coextensively disposed to said non-conductive base layer for insulating said signal distribution system from the body of a patient, said inner insulation layer having a predetermined thickness dependent upon said contact area dimension, said inner non-conductive layer further having a plurality of predetermined apertures exposing said conduction network contact areas, and having a void area at said terminal end exposing said signal distribution system,

d. conductive adhesive members affixed and coextensively disposed at each said plurality of predetermined apertures of said inner insulation layer for contact with said contact areas and the body of a patient to transfer electrical signals therebetween and for holding said device to the patient,

e. a conductive shielding layer generally coextensively affixed to said non-conductive base layer for reducing interference with and from the remaining elements of said body structure, and being exposed at the terminal end of said body structure for the electrical grounding of said device, said shielding layer further being peripherally recessed with respect to said non-conductive layers to minimize the risk of shorting and patient shock due to device or medical diagnostic and therapeutic apparatus malfunction, said contact area dimension, said base structure layer thickness, said shielding layer, and said conductive adhesive members cooperating to provide a low pass filter to shunt high frequency interference to ground, and,

f. an anatomical reference aperture through said base structure layer, inner insulation layer and shielding layer to align said predetermined contact areas with respect to the xiphoid process of a patient.

25. A method of receiving and transmitting electric current and voltage to the body of a patient for diagnostic and therapeutic purposes comprising:

a. selecting a set of specific locations on the body of a patient to be tested or treated,

b. providing an electrode belt device for placement on the body of the patient having a configuration to come into surface to surface contact with the predetermined patient body locations, said device further having a layered flexible body structure with electrode contact areas disposed at predetermined locations corresponding to said predetermined patient body locations and having at least one separable and extendible side member having an electrode contact areas therein, said belt device body structure further comprising a terminal end, a non-conductive base structure layer to which said electrode contact areas are affixed, a conduction network affixed to said base structure layer communicatively connecting said terminal end and said electrode contact areas, an inner non-conductive insulation layer affixed to and generally coextensive with said base structure layer and having apertures therein exposing said predetermined electrode contact areas, conductive adhesive members affixed and coextensively disposed at each said aperture, a release liner coextensively affixed to said conductive adhesive members, and having anatomical alignment means,

c. preparing said electrode belt device for application to the body of the patient by removing said release liner from said conductive adhesive members,

d. placing said electrode belt device on the body of the patient by reference to said anatomical alignment means so that said electrode contact areas correspond to said predetermined patient body locations,

e. separating said side member from the body structure of the belt device and placing the electrode contact area at a predetermined location,

f. connecting said terminal end of said electrode belt device to the cable set of a medical diagnostic or therapeutic apparatus,

g. performing a diagnostic or therapeutic procedure by utilizing said electrode belt device in communication with said medical apparatus, and

h. removing said electrode belt device from the body of the patient by pulling said electrode belt device from the skin, and disposing of said electrode belt device.