Electrocardiograph bioelectric interface system and method of use

• US 5,938,597 A
• Filed: 06/30/1997
• Issued: 08/17/1999
• 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:
  US08/885,690
• Time in Patent Office: 778 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

A bioelectric interface is disclosed which provides three Einthoven triangle equivalent lead forming electrodes positioned on a subject'"'"'s chest so as to provide a Wilson common terminal voltage essentially equivalent to that provided by an Einthoven triangle formed using leads positioned conventionally on a subject'"'"'s limbs. Wilson common terminal forming resistors can be of fixed values or variable to allow adjustment of a produced Wilson common terminal voltage. Additional precordial electrodes are also typiclaly present. Electrodes can consist of single elements or groups of electrode elements, and are present in locational regions of the bioelectric interface which allow a single size system 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. In addition, the present invention bioelectric interface is preferably held in place on a subject'"'"'s chest with hydropolymer, and need not be removed to allow cardio-pulmonary-resuscitation, defibrillation, cardiac pacing, electro surgery, electro ablation or impedance cardiography to be performed, and it serves to preserve the relative spatial integrity of the positioning of the electrodes present during use. The presence of a number of spatially separated electrocardiogram system electrodes facilitates reduction of the adverse electrode edge effects when defibrillation is performed through the bioelectric interface.

Claims

1. A bioelectric interface comprising a support sheet in functional combination with at least three (3) spatially separated electrocardiogram system electrodes, each of said at least three (3) spatially separated electrocardiogram system electrodes being of a construction selected from the group consisting of:

a single electrical electrode element; and

a group of electrically independent electrode elements;

each of said spatially separated electrocardiogram system electrodes being affixed to said support sheet in a manner such that the relative positions of said electrocardiogram system electrodes with respect to one another are essentially fixed therewithin, three (3) of said at least three (3) electrocardiogram system electrodes being configured in an RA, LA, LL electrocardiogram system electrode pattern,

said RA, LA and LL electrodes forming, when mounted to a subject'"'"'s chest in use, an Einthoven frontal lead triangle with an equivalent I, II, III lead pattern presenting with a voltage with respect to ground at a Wilson common terminal formed from "Y" connected resistors from each of said RA, LA and LL electrodes, said resistors each being selected from the group consisting of;

fixed; and

variable;

said voltage with respect to ground being within a selected range of deviation from a voltage with respect to ground which would present at a Wilson common terminal formed using conventional subject limb positioning of RA, LA and LL electrodes, said selected range of voltage deviation being selected from the group consisting of;

less than one (1.0) milivolt;

one (1.0) milivolt; and

greater than one (1.0) milivolt;

thereby enabling familiar ECG data acquisition from ECG leads which reference to said Wilson common terminal;

said bioelectric interface further comprising perforations in said support sheet which allow easy detachment and deployment of said Einthoven triangle forming RA, LA and LL electrodes, so that said Einthoven triangle forming RA, LA, and LL electrodes are, in use, each positionable at locations selected from the group consisting of;

in contact with a subject'"'"'s chest; and

in conventional Einthoven triangle forming subject limb positions.

2. A bioelectric interface as in claim 1 which further comprises an electrocardiogram system RL electrode.

3. A bioelectric interface as in claim 2 which further comprises perforations in said support sheet which allow easy detachment and deployment of said electrocardiogram RL electrode thereby enabling, in use, positioning thereof at a location selected from the group consisting of:

in contact with a subject'"'"'s chest; and

in conventional subject limb position.

4. A bioelectric interface as in claim 1 in which said Einthoven triangle forming RA, LA AND LL electrodes are, as applied to a subject'"'"'s chest during use, situated as follows:

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

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

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

5. A bioelectric interface as in claim 1, in which the support sheet is at least partially covered with an adhesive material on a side thereof which contacts a subject in use, which adhesive material presents with electrical conductive properties selected from the group consisting of:

isotropic electrical conductive properties; and

anisotropic electrical conductive properties such that regional specific impedance through said adhesive material is less that in a laterally oriented direction therealong.

6. A bioelectric interface as in claim 1, in which the support sheet is at least partially covered with an adhesive material on a side thereof which contacts a subject in use, the electrical conductive properties of said adhesive material being regionally anisotropic, said anisotropic electrical conductive properties of said adhesive material resulting from the presence of an electrically nonconductive scrim patterned therein so as to form channel regions of electrically conductive adhesive material through said adhesive material bordered by said scrim material, such that adhesive material in one channel region does not contact that in other regions.

7. A bioelectric interface as in claim 1, in which the support sheet is at least partially covered with an adhesive material on a side thereof which contacts a subject in use, the electrical conductive properties of said adhesive material being regionally anisotropic, said anisotropic electrical conductive properties of the adhesive material resulting from the presence of slits formed therein.

8. A bioelectric interface as in claim 1, in which the support sheet is at least partially covered with an adhesive material on a side thereof which contacts a subject in use, said adhesive material being a hydropolymer with electrical conductive properties selected from the group consisting of:

isotropic electrical conductive properties; and

anisotropic electrical conductive properties such that regional specific impedance through said adhesive material is less that in a laterally oriented direction therealong.

9. A bioelectric interface as in claim 8, in which the hydropolymer adhesive material covers essentially the entire side thereof which contacts a subject in use.

10. A bioelectric interface as in claim 1, in which at least one of said spatially separated electrocardiogram system electrodes is of a construction consisting of a group of electrically independent electrode elements.

11. A bioelectric interface as in claim 10, in which said electrically independent electrode elements are configured in a pattern selected from the group consisting of:

a Bulls-eye pattern; and

multiple button shaped electrode elements.

12. A method of providing an Einthoven triangle equivalent RA, LA, LL pattern of electrodes on the chest of a subject comprising the steps of:

a. providing a bioelectric interface comprising a support sheet in functional combination with at least three (3) spatially separated electrocardiogram system electrodes, at least one (1) of said at least three (3) spatially separated electrocardiogram system electrodes being of a construction consisting of a group of electrically independent electrode elements, each of said spatially separated electrocardiogram system electrodes being affixed to said support sheet in a manner such the relative positions of said electrocardiogram system electrodes with respect to one another are essentially fixed therewithin, three (3) of said at least three (3) electrocardiogram system electrodes being configured in an RA, LA, LL electrocardiogram system electrode pattern, said RA, LA and LL electrodes forming, in use, an Einthoven frontal lead triangle with an equivalent I, II, III lead pattern presenting with a voltage with respect to ground at a Wilson common terminal formed from "Y" connected resistors from each of said RA, LA and LL electrodes, said resistors each being selected from the group consisting of;

fixed; and

variable;

said voltage with respect to ground being within a selected range of deviation from a voltage with respect to ground which would be present at a Wilson common terminal formed using conventional subject limb positioning of RA, LA and LL electrodes, said selected range of voltage deviation being selected from the group consisting of;

less than one (1.0) milivolt;

one (1.0) milivolt; and

greater than one (1.0) milivolt;

thereby enabling familiar ECG data acquisition from ECG leads which reference to said Wilson common terminal;

b. applying said bioelectric interface to a subject;

c. selecting at least one electrically independent element in each of said at least one electrocardiogram system RA, LA and LL electrode(s) consisting of a group of electrically independent electrode elements to constitute the electrode of which it is an electrically independent element;

d. connecting said electrocardiogram system RA, LA and LL electrodes to appropriate inputs of an electrocardiogram system.

13. A method of providing an Einthoven triangle equivalent RA, LA, LL pattern of electrodes on the chest of a subject as in claim 12, 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;

d. electro surgery;

e. electro-ablation; and

f. impedance cardiography;

on said subject without removing said bioelectric interface.

14. A bioelectric interface comprising a support sheet in functional combination with at least nine (9) spatially separated electrocardiogram system electrodes, each of said at least nine (9) spatially separated electrocardiogram system electrodes being of a construction selected from a group consisting of:

a single electrical electrode element; and

a group of electrically independent electrode elements;

each of said spatially separated electrocardiogram system electrodes being affixed to said support sheet in a manner such that the relative positions of said electrocardiogram system electrodes with respect to one another are essentially fixed therewithin, nine (9) of said at least nine (9) electrocardiogram system electrodes being configured in an RA, LA, LL, V1, V2, V3, V4, V5, V6 electrocardiogram system electrode pattern, such that said nine (9) electrocardiogram system electrodes are applied to a subject'"'"'s chest during use as follows;

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

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

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

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

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

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

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

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

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

said electrodes RA, LA and LL being positioned so as to form, in use, an Einthoven frontal lead triangle with an equivalent I, II, III lead pattern presenting with a voltage with respect to ground at a Wilson common terminal formed from "Y" connected resistors from each of said RA, LA and LL electrodes, said resistors each being selected from the group consisting of;

fixed; and

variable;

said voltage with respect to ground being within a selected range of deviation from a voltage respect to ground which would present at a Wilson common terminal formed using conventional subject limb positioning of RA, LA and LL electrodes, said selected range of voltage deviation being selected from the group consisting of;

less than one (1.0) milivolt;

one (1.0) milivolt; and

greater than one (1.0) milivolt);

thereby enabling familiar ECG data acquisition from ECG leads which reference to said Wilson common terminal;

said bioelectric interface further comprising perforations in said support sheet which allow easy detachment and deployment of said Einthoven triangle forming RA, LA and LL electrodes therefrom so that said Einthoven triangle forming RA, LA, and LL electrodes are, in use, positionable at locations selected from the group consisting of;

in contact with a subject'"'"'s chest; and

in conventional Einthoven triangle subject limb positions.

15. A bioelectric interface as in claim 14 which further comprises an electrocardiogram system RL electrode.

16. A bioelectric interface as in claim 15 which further comprises perforations in said support sheet which allow easy detachment and deployment of said electrocardiogram RL electrode thereby enabling, in use, positioning thereof at a location selected from the group consisting of:

in contact with a subject'"'"'s chest; and

in conventional subject limb position.

17. A bioelectric interface as in claim 14, in which the support sheet is at least partially covered with an adhesive material on a side thereof which contacts a subject in use, which adhesive material presents with electrical conductive properties selected from the group consisting of:

isotropic electrical conductive properties; and

anisotropic electrical conductive properties such that the regional specific impedance through said adhesive material is less than in a laterally oriented dimension direction therealong.

18. A bioelectric interface as in claim 14 in which the support sheet is at least partially covered with an adhesive material on a side thereof which contacts a subject in use, the electrical conductive properties of said adhesive material being anisotropic, said anisotropic electrical conductive properties of said adhesive material resulting from the presence of an electrically nonconductive scrim patterned therein so as to form channel regions of electrically conductive adhesive material through said adhesive material bordered by said scrim material, such that adhesive material in one channel region does not contact that in other regions.

19. A bioelectric interface as in claim 14, in which the support sheet is at least partially covered with an adhesive material on a side thereof which contacts a subject in use, the electrical conductive properties of said adhesive material being anisotropic, said anisotropic electrical conductive properties of the adhesive material resulting from the presence of slits formed therein.

20. A bioelectric interface as in claim 14, in which the support sheet is at least partially covered with an adhesive material on a side thereof which contacts a subject in use, said adhesive material being a hydropolymer with isotropic electrical conductive properties.

21. A bioelectric interface as in claim 20, in which the hydropolymer adhesive material covers essentially the entire surface of said support sheet on the side thereof which contacts a subject in use.

22. A bioelectric interface as in claim 14 in which the support sheet is at least partially covered with an adhesive material on a side thereof which contacts a subject in use, said adhesive material being a hydropolymer with regional anisotropic electrical conductive properties.

23. A bioelectric interface as in claim 22, in which the hydropolymer adhesive material covers essentially the entire surface of said support sheet on the side thereof which contacts a subject in use.

24. A bioelectric interface as in claim 14, in which at least one of said spatially separated electrocardiogram system electrodes is of a construction consisting of a group of electrically independent electrode elements.

25. A bioelectric interface as in claim 24, in which said electrically independent electrode elements are configured in a pattern selected from the group consisting of:

a Bulls-eye pattern; and

multiple button shaped electrode elements.

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

a. providing a bioelectric interface comprising a support sheet in functional combination with at least nine (9) spatially separated electrocardiogram system electrodes, each of said at least nine (9) spatially separated electrocardiogram system electrodes being of a construction selected from a group consisting of;

a single electrical electrode element; and

a group of electrically independent electrode elements;

each of said spatially separated electrocardiogram system electrodes being affixed to said support sheet in a manner such the relative positions of said electrocardiogram system electrodes with respect to one another are essentially fixed therewithin, nine (9) of said at least nine (9) electrocardiogram system electrodes being configured in an RA, LA, LL, V1, V2, V3, V4, V5, V6 electrocardiogram system electrode pattern, such that said nine (9) electrocardiogram system electrodes are applied to a subject'"'"'s chest during use as follows;

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

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

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

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

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

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

said electrodes RA, LA and LL being positioned so as to form, in use, an Einthoven frontal lead triangle with an equivalent I, II, III lead pattern presenting with a voltage with respect to ground at a Wilson common terminal formed from "Y" connected resistors from each of said RA, LA and LL electrodes, at least one of said resistors from each of said RA, LA and LL electrodes being variable;

said voltage with respect to ground being within a selected range of deviation from a voltage respect to ground which would present at a Wilson common terminal formed using conventional subject limb positioning of RA, LA and LL electrodes, said selected range of voltage deviation being selected from the group consisting of;

less than one (1.0) milivolt;

one (1.0) milivolt; and

greater than one (1.0) milivolt;

thereby enabling familiar ECG data acquisition from ECG leads which reference to said Wilson common terminal;

b. affixing said bioelectric interface to a subject and causing electrodes therein to be electrically attached to an electrocardiographic system;

c. adjusting the resistance value of at least one of said at least one Wilson common terminal forming "Y" connected resistors, from each of said RA, LA and LL electrodes, which is variable, to place the Wilson common terminal voltage within a selected range of deviation from a voltage which would present at a Wilson common terminal formed using conventional subject limb positioning of RA, LA and LL electrodes, said range being selected from the group consisting of;

less than one (1.0) milivolt;

one (1.0) milivolt; and

greater than one (1.0) milivolt);

such that familiar electrocardiographic data from ECG leads which reference to said Wilson common terminal, is obtained.

27. A method of acquiring electrocardiographic data as in claim 26, in which the step of providing a bioelectric interface includes providing perforation(s) in said support sheet such that at least one of said three electrodes configured in an Einthoven frontal lead triangle equivalent RA, LA, and LL pattern can be easily removed therefrom;

said method of acquiring electrocardiographic data further including the step of removing said at least one of said electrode(s) RA, LA and LL which are configured in an Einthoven frontal lead triangle equivalent LA, RA, LL pattern, and affixing it/them to conventional subject limb locations.

28. A method of acquiring electrocardiographic data as in claim 26, in which the step of providing a bioelectric interface includes providing an adhesive material present over at least a portion of a side of said support sheet which contacts a subject in use.

29. A method of acquiring electrocardiographic data as in claim 26, in which the step of providing said bioelectric interface comprises the step of causing at least some of said electrodes to comprise a group of electrically independent electrode elements configured in a pattern selected from the group consisting of:

Bulls-eye pattern; and

multiple button shaped electrode elements.

30. A method of acquiring electrocardiographic data as in claim 26, 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;

d. electro surgery;

e. electro-ablation; and

f. impedance cardiography;

on said subject without removing said bioelectric interface.

31. A method of acquiring electrocardiographic data as in claim 26, which further comprises the step of performing cardiac defibrillation utilizing two conventional defibrillation paddles, in which a first conventional defibrillation paddle contacts at least two of said at least nine electrocardiogram system electrodes, and in which a second said conventional defibrillation paddles contacts at least two of said at least nine electrocardiogram system electrodes, said at least two electrodes contacted by said first conventional defibrillation paddle being different than and sread apart from said at least two electrodes contacted by said second conventional defibrillation paddle;

with the result being that in use said electrodes contacted by said defibrillation paddles are caused to be pressed into firm contact with a subject and defibrillation pulse current delivered thereto with current distribution electrode edge effects being reduced.

32. A bioelectric interface comprising a support sheet in functional combination with at least three (3) spatially separated electrocardiogram system electrodes, each of said at least three (3) spatially separated electrocardiogram system electrodes being of a construction selected from the group consisting of:

a single electrical electrode element; and

a group of electrically independent electrode elements;

each of said spatially separated electrocardiogram system electrodes being affixed to said support sheet in a manner such that the relative positions of said electrocardiogram system electrodes with respect to one another are essentially fixed therewithin, three (3) of said at least three (3) electrocardiogram system electrodes being configured in an RA, LA, LL electrocardiogram system electrode pattern;

which RA, LA and LL electrodes, when functionally combined with resistors from each thereof, which resistors are "Y" interconnected to provide a Wilson central terminal, form an Einthoven frontal lead triangle with an equivalent I, II, III lead pattern when mounted to a subject'"'"'s chest;

such that when mounted to a subject'"'"'s chest in use a voltage with respect to ground developed at said Wilson central terminal is within a selected range of deviation from a voltage with respect to ground which would present at a Wilson central terminal formed using conventional subject limb positioning of said RA, LA and LL electrodes, said selected range of voltage deviation being selected from the group consisting of;

less than one (1.0) milivolt;

one (1.0) milivolt; and

greater than one (1.0) milivolt;

thereby enabling familiar ECG data acquisition from ECG leads which reference to said Wilson central terminal;

said bioelectric interface further comprising perforation(s) in said support sheet which allow easy detachment and deployment of at least one of said Einthoven frontal lead triangle forming RA, LA and LL electrodes, so that said at least one of said Einthoven triangle forming RA, LA, and LL electrodes is/are, in use, positionable at locations selected from the group consisting of;

in contact with a subject'"'"'s chest; and

in conventional Einthoven triangle forming subject limb positions.

33. A bioelectric interface comprising a support sheet in functional combination with at least three (3) spatially separated electrocardiogram system electrodes as in claim 32, wherein at least one of said RA, LA and LL electrodes, when mounted to a subject'"'"'s chest, is positioned as:

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

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

said electrode LL being generally in the region of the inferior costal margin in the left mid-clavicular line.

34. A bioelectric interface comprising a support sheet in functional combination with at least three (3) spatially separated electrocardiogram system electrodes, each of said at least three (3) spatially separated electrocardiogram system electrodes being of a construction selected from the group consisting of:

a single electrical electrode element; and

a group of electrically independent electrode elements;

each of said spatially separated electrocardiogram system electrodes being affixed to said support sheet in a manner such that the relative positions of said electrocardiogram system electrodes with respect to one another are essentially fixed therewithin, three (3) of said at least three (3) electrocardiogram system electrodes being configured in an RA, LA, LL electrocardiogram system electrode pattern;

which RA, LA and LL electrodes, when functionally combined with resistors from each thereof which are "Y" interconnected to provide a Wilson central terminal, form an Einthoven frontal lead triangle with an equivalent I, II, III lead pattern when mounted to a subject'"'"'s chest in use;

at least one of said resistors from said RA, LA and LL electrodes which are "Y" interconnected being variable such that, in use, said at least one resistor which is variable is adjusted to place the voltage which presents at the Wilson central terminal within a range of deviation from a voltage which would present at a Wilson central terminal formed using conventional subject limb positioning of RA, LA and LL electrodes, said range of deviation being selected from the group consisting of;

less than one (1.0) milivolt;

one (1.0) milivolt; and

greater than one (1.0) milivolt;

thereby enabling familiar ECG data acquisition from ECG leads which reference to said Wilson central terminal.

35. A bioelectric interface comprising a support sheet in functional combination with at least three (3) spatially separated electrocardiogram system electrodes as in claim 34, said bioelectric interface further comprising perforation(s) in said support sheet which allow easy detachment and deployment of at least one of said Einthoven frontal lead triangle forming RA, LA and LL electrodes, so that said at least one of said Einthoven triangle forming RA, LA, and LL electrodes is/are, in use, positionable at locations selected from the group consisting of:

in contact with a subject'"'"'s chest; and

in conventional Einthoven triangle forming subject limb positions.