Anisotropic adhesive multiple electrode system, and method of use

• US 5,678,545 A
• Filed: 05/04/1995
• Issued: 10/21/1997
• Est. Priority Date: 05/04/1995
• Status: Expired due to Fees

• Current Assignee: Robert A. Stratbucker
• Original Assignee: Robert A. Stratbucker
• Inventors: Stratbucker, Robert A.
• Primary Examiner(s): Cohen, Lee S.
• Application Number:
  US08/434,658
• Time in Patent Office: 901 Days
• Field of Search: 128/639-641, 128/644, 607/148, 607/149, 607/152, 607/153, 606/32
• US Class Current: 600/393
• CPC Class Codes: A61B 5/259 using conductive adhesive means, e.g. gels
• CPC Class Codes: A61B 5/28 for electrocardiography [ECG]
• CPC Class Codes: A61B 5/282 Holders for multiple electrodes for introduction into the body A61B5/287
• CPC Class Codes: A61N 1/04 Electrodes electrosurgical electrodes A61B18/14

Abstract

A bioelectric interface is disclosed which provides a plurality of electrodes affixed to an adhesive sheet which demonstrates electrode isolating anisotropic electrical specific impedance properties simultaneous with isotropic pliability and adhesion mechanical properties. The bioelectric interface can be configured to provide electrodes positioned for use in, for instance, twelve lead (ECG) systems as well as in any other configuration. Groups of electrodes can be present in certain locational regions to allow single sized systems to fit to patients with various sized bodies. The electrodes can be of various physical shapes to allow not only direct signal measurement, but also to allow monitoring of high frequency content of signals and to allow enhanced resolution of a region from which measured signals originate. When present, extra electrodes in a group thereof can be used for purposes, such as cardiac pacing. In addition, the present invention bioelectric interface need not be removed to allow cardio-pulmonary-resuscitation or defibrillation to be performed, and it serves to preserve the relative spacial integrity of the positioning of the electrodes present during use.

Claims

1. A bioelectric interface comprising an adhesive sheet in functional combination with at least two spacially separated electrodes, which adhesive sheet simultaneously presents with essentially anisotropic specific impedance properties and essentially isotropic mechanical pliability and adhesion properties, said electrodes being affixed to said adhesive sheet in a manner such that their relative positions with respect to one another are essentially fixed, and such that the specific impedance from each said electrode directly through said adhesive sheet, is less than that between any said electrodes through said adhesive sheet, said electrical anisotropic specific impedance properties of said adhesive sheet being the result of a slit or slits therein, which slit or slits is/are positioned between electrodes.

2. A bioelectric interface as in claim 1, in which the adhesive sheet is comprised of electrically conductive polymer.

3. A bioelectric interface as in claim 2, in which the electrically conductive polymer is hydrophillic, and thereby particularly well suited for application to human skin.

4. A bioelectric interface as in claim 1, in which the electrodes are each of a construction such that contact with the adhesive sheet is essentially continuous over the dimension of each said electrode.

5. A bioelectric interface as in claim 1, in which at least one of said electrodes is of a multiple-piece construction such that each of said multiple pieces contacts the adhesive sheet independently and essentially continuously over the dimension of each said multiple pieces.

6. A bioelectric interface as in claim 5 in which the multipiece construction configures a Bulls-eye pattern.

7. A bioelectric interface as in claim 6, in which there are present a multiplicity of electrodes configured in an essentially rectangular shaped matrix such that in use said bioelectric interface is affixed to one of the group consisting of a patient'"'"'s chest and back, said bioelectric interface being appropriate for use in electrocardiographic mapping.

8. A bioelectric interface as in claim 1, which further comprises a tarrier matrix affixed thereto so as to sandwich said electrodes between said carrier matrix and said adhesive sheet, the purpose being to improve the integrity of the spacial separation between said electrodes.

9. A bioelectric interface as in claim 1, which further comprises means for electrically connecting said electrodes to external devices.

10. A bioelectric interface as in claim 1, in which there are present a multiplicity of electrodes configured in an essentially rectangular shaped matrix such that in use said bioelectric interface is affixed to one of the group consisting of a patient'"'"'s chest and back, said bioelectric interface being appropriate for use in electrocardiographic mapping.

11. A bioelectric interface comprising an adhesive sheet in functional combination with at least two spacially separated groups of electrode(s), at least one of which spacially separated group of electrode(s), can consist of more than one electrode, which adhesive sheet simultaneously presents with essentially anisotropic specific impedance properties and essentially isotropic pliability and adhesion mechanical properties, electrodes in said spacially separated groups of electrode(s) being affixed to said adhesive sheet in a manner such the relative positions of electrodes present with respect to one another are essentially fixed, and such that the specific impedance from each electrode in said groups of spacially separated electrodes(s) directly through said adhesive sheet, is less than that between any two electrodes in different spacially separated groups of electrodes through said adhesive sheet, said electrical anisotropic specific impedance properties of said adhesive sheet being the result of a slit or slits therein, which slit or slits is/are positioned between groups of electrodes.

12. A bioelectric interface as in claim 11, in which the adhesive sheet is comprised of electrically conductive polymer.

13. A bioelectric interface as in claim 12, in which the electrically conductive polymer is hydrophillic, and thereby particularly well suited for application to human skin.

14. A bioelectric interface as in claim 13, which further comprises three additional groups of electrode(s) which are configured and sized so as to place said additional three groups of electrodes in an essentially congruent Einthoven triangle equivalent Left Arm, Right Arm, Left Leg pattern, such that in use all said groups of electrodes contact a patient'"'"'s chest.

15. A bioelectric interface as in claim 11, in which the electrodes in the groups of electrode(s) are each of a construction such that contact with the adhesive sheet is essentially continuous over the dimension of each said electrode.

16. A bioelectric interface as in claim 11, in which at least one of said electrodes in said groups of electrode(s) is of a multiple-piece construction such that each of said multiple pieces contacts the adhesive sheet independently and essentially continuously over the dimension of each said multiple pieces.

17. A bioelectric interface as in claim 16, in which the multipiece construction configures a Bulls-eye pattern.

18. A bioelectric interface as in claim 11, which further comprises a carrier matrix affixed thereto so as to sandwich said electrodes in said groups of electrode(s) between said carrier matrix and said adhesive sheet, the purpose being to improve the integrity of the spacial separation between said electrodes.

19. A bioelectric interface as in claim 11, which further comprises means for electrically connecting said electrodes in said groups of electrode(s) to external devices.

20. A bioelectric interface as in claim 11, in which the number of groups of electrode(s) is three, said bioelectric interface being configured and sized so as to place said three groups of electrodes in an essentially congruent Einthoven triangle equivalent Left Arm, Right Arm, Left Leg pattern, such that in use all said groups of electrodes contact a patient'"'"'s chest.

21. A bioelectric interface as in claim 11, in which the number of groups of electrode(s) is nine, said nine groups of electrode(s) being configured in an I, II, III, V1, V2, V3, V4, V5, V6 twelve lead electrocardiogram system electrode pattern, such that said nine groups of electrode(s) are positioned on a patient'"'"'s chest during use as follows:

electrode group I in the region of the second intercostal space to the right of the sternum;

electrode group II in the region of the second intercostal space at the mid-axillary line;

electrode group III in the region of the inferior costal margin in the mid-clavicular line;

electrode group V1 in the region of the fourth intercostal space at the right sternal border;

electrode group V2 in the region of the fourth intercostal space at the left sternal border;

electrode group V4 in the region of the fifth intercostal space at the mid-clavicular line;

electrode group V3 in the region of the midpoint between electrode groups V2 and V4;

electrode group V5 in the region of the fifth intercostal space in the anterior axillary line; and

electrode group V6 in the region of the fifth intercostal space in the mid-axillary line;

such that during use one electrode from each group of electrode(s) will be found to be more appropriately situated for a specific patient depending upon the patient'"'"'s body size.

22. A method of acquiring electrocardiographic data comprising the steps of:

a. providing a bioelectric interface comprising at least two spacially separated groups of electrode(s), at least one of which spacially separated group of electrode(s) can consist of more than one electrode, which adhesive sheet presents with essentially anisotropic specific impedance properties but essentially isotropic mechanical properties, said spacially separated groups of electrode(s) being affixed to said adhesive sheet in a manner such that their relative positions with respect to one another remain essentially fixed, and such that the specific impedance from each electrode in said groups of spacially separated electrode(s) directly through said adhesive sheet, is less than that between any two electrodes in different spacially separated groups of electrodes through said adhesive sheet, said electrical anisotropic specific impedance properties of said adhesive sheet being the result of a slit or slits therein, which slit or slits is/are positioned between groups of electrodes, in which bioelectric interface the number of groups of electrode(s) is nine, said nine groups of electrode(s) being configured in an I, II, Ill, V1, V2, V3, V4, V5, V6 twelve lead electrocardiogram system electrode pattern, such that said nine groups of electrode(s) are positioned on a patient'"'"'s chest during use as follows;

electrode group I in the region of the second intercostal space to the right of the sternum;

electrode group II in the region of the second intercostal space at the mid-axillary line;

electrode group III in the region of the inferior costal margin in the mid-clavicular line;

electrode group V1 in the region of the fourth intercostal space at the right sternal border;

electrode group V2 in the region of the fourth intercostal space at the left sternal border;

electrode group V4 in the region of the fifth intercostal space at the mid-clavicular line;

electrode group V3 in the region of the midpoint between electrode groups V2 and V4;

electrode group V5 in the region of the fifth intercostal space in the anterior axillary line; and

electrode group V6 in the region of the fifth intercostal space in the mid-axillary line;

such that during use one electrode from each group of electrode(s) will be found to be more appropriately situated for a specific patient depending upon the patient'"'"'s body size;

b. affixing said bioelectric interface to a patient and causing the electrodes therein to be electrically attached to an electrocardiographic system such that electrocardiographic data is obtained.

23. A method of acquiring electrocardiographic data as in claim 22, which further comprises the simultaneous step of performing a procedure selected from the group consisting of;

a. cardio-pulmonary resuscitation

b. cardiac defibrillation;

c. cardiac pacing; and

d. electro surgery;

on said patient without removing said bioelectric interface.

24. A method of acquiring electrocardiographic data as in claim 22, which further comprises the simultaneous step of causing at least some some of said electrodes to have a multiple component configuration.

25. A method of performing cardiac mapping comprising the steps of:

a. providing a bioelectric interface comprising an adhesive sheet in functional combination with at least two spacially separated electrodes, which adhesive sheet presents with essentially anisotropic specific impedance properties but essentially isotropic mechanical properties, said electrodes being affixed to said adhesive sheet in a manner such that their relative positions with respect to one another remain essentially fixed, and such that the specific impedance from each said electrode directly through said adhesive sheet, is less than that between any said electrodes through said adhesive sheet, said electrical anisotropic specific impedance properties of said adhesive sheet being the result of a slit or slits therein, which slit or slits is/are positioned between electrodes, in which bioelectric interface there are present a multiplicity of electrodes configured in an essentially rectangular shaped matrix such that in use said bioelectric interface is affixed to one of the group consisting of a patient'"'"'s chest and back, said bioelectric interface being appropriate for use in electrocardiographic mapping;

b. affixing said bioelectric interface to a patient on one of the elements in the group consisting of a patient'"'"'s chest and back, and causing said electrodes to be connected to an electrocardiograph mapping system.

26. A method of acquiring electrocardiographic data as in claim 25, which further comprises the simultaneous step of performing a procedure selected from the group consisting of;

a. cardio-pulmonary resuscitation

b. cardiac defibrillation;

c. cardiac pacing; and

d. electro surgery.

27. A method of acquiring electrocardiographic data as in claim 25, which further comprises the simultaneous step of causing at least some of said electrodes to have a multiple component configuration.