Bioelectric interface

• US 6,327,487 B1
• Filed: 08/16/1999
• Issued: 12/04/2001
• 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:
  US09/374,873
• Time in Patent Office: 841 Days
• Field of Search: 600/382, 600/388-391, 600/393, 607/148, 607/149, 607/152
• US Class Current: 600/382
• 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 1/046 Specially adapted for shock therapy, e.g. defibrillation
• CPC Class Codes: A61N 1/0476 Array electrodes (including any electrode arrangement with more than one electrode for at least one of the polarities)
• CPC Class Codes: A61N 1/0492 Patch electrodes A61N1/0412, A61N1/0428 take precedence

Abstract

Disclosed is a bioelectric interface containing at least two electrodes and which is characterized as a support sheet with such attributes as an undulated outer edge, and/or with holes therethrough which allow access to a subject'"'"'s ski in use, and/or with perforations therein which allow easy detaching and deployment of electrodes therefrom is disclosed. The preferred version has all electrodes necessary to perform twelve lead ECG monitoring. The bioelectric interface includes an adhesive sheet in functional combination with the support sheet, which adhesive sheet simultaneously presents with, preferably, scrim and/or slit effected essentially anisotropic specific impedance properties in combination with essentially isotropic mechanical pliability and adhesion properties. The electrodes are affixed to the support sheet in a manner such that their relative positions with respect to one another are essentially fixed. The present invention also provides for spring-loaded electrode contact improving access.

Claims

1. A bioelectric interface comprising an adhesive sheet in functional combination with at least two spatially 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 scrim therein, which scrim is a web of material having no electrically conductive adhesive material impregnated thereinto but having relatively electrically conductive adhesive material present in open areas of said web so as to form channel regions of electrically conductive adhesive material bordered by said scrim web material, such that electrically conductive adhesive material in one channel region does not contact that in other regions, at least one of said at least two spatially separated electrodes having a region of said scrim web material positioned thereunder, as viewed in side elevation.

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 carrier 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 spatially separated regions of electrode(s), at least one of which spatially separated region 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, electrode(s) in each of said spatially separated regions 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 regions of spatially separated electrode(s) directly through said adhesive sheet, is less than that between any two electrodes in different spatially separated regions of electrode(s) through said adhesive sheet, said electrical anisotropic specific impedance properties of said adhesive sheet being the result of at least one selection from the group consisting of:

scrim therein, which scrim is a web of material having no electrically conductive adhesive material impregnated thereinto but but having relatively electrically conductive adhesive material present in open areas of said web so as to form channel regions of electrically conductive adhesive material bordered by said scrim web material, such that electrically conductive adhesive material in one channel region does not contact that in other regions, at least one of said at least two spatially separated electrodes having a region of said scrim web material positioned thereunder, as viewed in side elevation; and

slits therein, which slits are positioned between 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 11, in which the electrodes in the regions 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.

15. A bioelectric interface as in claim 11, in which at least one of said electrodes in said regions 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.

16. A bioelectric interface as in claim 15, in which the multipiece construction configures a Bulls-eye pattern.

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

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

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

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

electrode region RA generally in the region of the second intercostal space to the right of the sternum;

electrode region LA generally in the region of the left fourth intercostal space at the mid-axillary line;

electrode region LL generally in the region of the inferior costal margin in the left mid-clavicular line;

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

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

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

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

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

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

21. A bioelectric interface as in claim 11, which comprises three regions of electrode(s) which are configured and sized so as to place electrode(s) in said three regions of electrodes in an Einthoven triangle Left Arm, Right Arm, Left Leg pattern, such that in use all said regions of electrodes contact a patient'"'"'s chest as verified by the appearance of a voltage at a Wilson central terminal formed by attaching impedances from electrodes in each of said three regions of electrode(s) in a “

Y”

configuration which is within some selected deviation from a voltage which would appear at a Wilson central terminal formed by attaching impedances from electrodes affixed to conventional RA, LA and LL into a “

Y”

configuration.

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

a. providing a bioelectric interface comprising an adhesive sheet in functional combination with at least two spatially separated separated regions of electrode(s), at least one of which spatially separated region 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 spatially separated regions 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 regions of spatially separated electrode(s) directly through said adhesive sheet, is less than that between any two electrodes in different spatially separated regions of electrodes through said adhesive sheet, said electrical anisotropic specific impedance properties of said adhesive sheet being the result of at least one selection from the group consisting of;

scrim therein, which scrim is a web of material having no electrically conductive adhesive material impregnated thereinto but but having relatively electrically conductive adhesive material present in open areas of said web so as to form channel regions of electrically conductive adhesive material bordered by said scrim web material, such that electrically conductive adhesive material in one channel region does not contact that in other regions, at least one of said at least two spatially separated electrodes having a region of said scrim web material positioned thereunder, as viewed in side elevation; and

slits therein, which slits are positioned between electrodes;

in which bioelectric interface the number of regions of electrode(s) is nine, said nine regions of electrode(s) being configured in an RA, LA, LL, V1, V2, V3, V4, V5, V6 twelve lead electrocardiogram system electrode pattern, such that at least some of said nine regions of electrode(s) are positioned on a patient'"'"'s chest during use as follows;

electrode region RA generally in the region of the second intercostal space to the right of the sternum;

electrode region LA generally in the region of the left fourth intercostal space at the mid-axillary line;

electrode region LL generally in the region of the inferior costal margin in the left mid-clavicular line;

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

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

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

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

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

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

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 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 step of causing at least some of said electrodes to have 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 spatially 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 at least one selection from the group consisting of;

scrim therein, which scrim is a web of material having no electrically conductive adhesive material impregnated thereinto but having relatively electrically conductive adhesive material present in open areas of said web so as to form channel regions of electrically conductive adhesive material bordered by said scrim web material, such that electrically conductive adhesive material in one channel region does not contact that in other regions, at least one of said at least two spatially separated electrodes having a region of said scrim web material positioned thereunder, as viewed in side elevation; and

slits therein, which slits 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'"'"'s 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 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.