Flexible and disposable electrode belt device

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.

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:
• 1. a non-conductive base layer for insulation of an supporting the remaining elements of said main structure,
• 2. 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,
• 3. 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
• 2. 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.

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.

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.