Bio-electic interface adapter with twelve-lead ECG capability and provision for defibrillation

• US 6,532,379 B2
• Filed: 02/06/2001
• Issued: 03/11/2003
• 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:
  US09/777,296
• Publication Number:
  US 20010027270A1
• Time in Patent Office: 763 Days
• Field of Search: 600/372, 600/382, 600/388-391, 600/393, 607/142, 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: A61B 5/7239 using differentiation including higher order derivatives
• 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 bio-electic interface adapter with at least two large area defibrilation electrodes and sufficient smaller precordial electrodes present therein to allow standard twelve lead ECG monitoring. The defibrillation electrodes can be affixed to the bioelectric interface via perforations, or by a functionally similar approach, to allow easy detachment in use. The bioelectric interface adaptor preferably has an undulated outer edge geometry, and provides electrodes for forming limb leads, optionally allowing use of the defibrillation electrodes as Right Arm and Left Leg electrodes. Limb lead forming electrodes are preferable affixed via perforations, or by a functionally similar approach, to allow easy detachment and deployment to conventional limb electrode locations, in use.

Claims

1. A bioelectric interface comprising at least two defibrillation electrodes as an integral part thereof, there being perforations, or functional equivalent, in said bioelectric interface, positioned to allow easy detachment of at least one of said defibrillation electrodes, said bioelectric interface further comprising sufficient precordial electrodes to monitor twelve lead ECG'"'"'s.

2. A bioelectric interface as in claim 1, in which

the defibrillation electrodes have affixed thereto electrodes appropriate for use as right-arm and left-leg limb electrodes;

or

the defibrillation electrodes are used for both defibrillation and as right arm and left leg limb electrodes.

3. A bioelectric interface as in claim 1, which further comprises ECG limb lead forming electrodes (RA) (LA) and (LL) configured in an RA, LA, LL electrocardiogram system electrode pattern;

said defibrillation electrodes optionally being said (RA) and (LL) limb electrodes;

which RA, LA and LL electrodes, when functionally combined with summing impedances from each thereof, which summing impedances are “

Y”

interconnected to provide a Wilson central terminal, form an Einthoven frontal lead triangle with a I, II, III lead pattern when mounted to a subject'"'"'s chest, said Einthoven frontal lead triangle with a I, II, III lead pattern being positioned on said subject'"'"'s chest so as to provide a voltage which presents at said Wilson central terminal which is within a selected range of deviation from a voltage which would appear at a Wilson central terminal formed from summing impedances from conventional limb mounted electrodes which are “

Y”

interconnected;

said (RA) and (LL) each being a selection from the group consisting of;

one of the defibrillation electrodes; and

an electrode other than one of the defibrillation electrodes.

4. A bioelectric interface as in claim 1, which further comprises six precordial V1, V2, V3, V4, V5 and V6, and three limb RA, LA and LL lead electrodes located in regions as:

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

electrode region LA generally in the region of the left third or 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.

5. A bioelectric interface comprising a carrier matrix in functional combination with at least two spatially separated defibrillation electrodes, and V1, V2, V3, V4, V5, and V6 precordial electrodes and RA, LA and LL limb lead forming electrodes, said electrodes being affixed to said carrier matrix in a manner such that their relative positions with respect to one another are essentially fixed, said RA, LA, LL limb lead electrodes being positioned such that when functionally combined with summing impedances from each thereof, which summing impedances are “

Y”

interconnected to provide a Wilson central terminal, form an Einthoven frontal lead triangle with a I, II, III lead pattern when mounted to a subject'"'"'s chest, said Einthoven frontal lead triangle with a I, II, III lead pattern being positioned on said subject'"'"'s chest so as to provide a voltage which presents at said Wilson central terminal which is within some selected range of deviation from a voltage which would appear at a Wilson central terminal formed from summing impedances from conventional limb mounted electrodes which are “

Y”

interconnected;

the improvement being that there are perforations, or functional equivalent, in said bioelectric interface, positioned to allow easy detachment of at least one of said spatially separated defibrillation electrodes.

6. A bioelectric interface as in claim 5, which further comprises an adhesive comprised of electrically conductive polymer affixed to said carrier matrix on a side thereof which contacts said subject'"'"'s chest in use.

7. A bioelectric interface as in claim 6, in which the electrically conductive polymer is hydrophillic, and thereby particularly well suited for application to human skin.

8. A bioelectric interface as in claim 6, in which the defibrillation electrodes, and V1, V2, V3, V4, V5, and V6 precordial electrodes and RA, LA and LL limb lead forming electrodes, are each of a construction such that contact with the adhesive is essentially continuous over the dimension of each said electrode.

9. A bioelectric interface as in claim 6, in which at least one of said electrodes is of a multiple-piece construction such that each of said multiple pieces contacts the adhesive independently and essentially continuously over the dimension of each said multiple pieces.

10. A bioelectric interface as in claim 9, in which the multipiece construction configures a Bulls-eye pattern.

11. A bioelectric interface as in claim 5, which further comprises an adhesive sheet affixed thereto so as to sandwich said electrodes between said carrier matrix and said adhesive sheet, the purpose being to improve subject adherence.

12. A bioelectric interface as in claim 5, which further comprises means for electrically connecting said electrodes to external devices.

13. A bioelectric interface as in claim 5, 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 a subject'"'"'s chest or back, said bioelectric interface being appropriate for use in electrocardiographic mapping.

14. A bioelectric interface as in claim 5, in which there are present a multiplicity of electrodes configured in an RA, LA, LL, V1, V2, V3, V4, V5, V6 twelve lead electrocardiogram system electrode pattern, such that nine regions of electrode(s) are positioned on a subject'"'"'s chest during use.

27. A method of defibrilating a subject as in claim 14, which further comprises the step of performing a procedure selected from the group consisting of;

a. cardio-pulmonary resuscitation

b. ECG monitoring;

c. cardiac pacing;

d. electro surgery;

e. electro-ablation;

f. impedance cardiography;

g. transdermal drug or nutrient transfer; and

h. electromechanical energy transfer or detection;

on said subject without removing said bioelectric interface.

15. A bioelectric interface comprising an adhesive sheet in functional combination with at least two spatially separated regions of defibrillation electrode(s), at least one of which spatially separated region of defibrillation 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 the thickness of 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 scrim therein, which scrim is a web of material with 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 material, such that adhesive material in one channel region does not contact that in other regions;

and/or slits therein, which slits are positioned between electrodes;

there being perforations, or functional equivalent, in said bioelectric interface, positioned to allow easy detachment of at least one of said spatially separated defibrillation electrodes.

16. A bioelectric interface as in claim 15, in which the adhesive sheet is comprised of electrically conductive polymer.

17. A bioelectric interface as in claim 16, in which the electrically conductive polymer is hydrophillic, and thereby particularly well suited for application to human skin.

18. A bioelectric interface as in claim 15, 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.

19. A bioelectric interface as in claim 15, 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.

20. A bioelectric interface as in claim 19, in which the multipiece construction configures a Bulls-eye pattern.

21. A bioelectric interface as in claim 15, 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.

22. A bioelectric interface as in claim 15, which further comprises means for electrically connecting said electrodes in said regions of electrodes to external devices.

23. A bioelectric interface as in claim 15, which further comprises at least three additional regions of electrodes, 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 subject'"'"'s chest.

24. A bioelectric interface as in claim 15, which further comprises at least 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 subject'"'"'s chest during use as follows:

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

electrode region LA generally in the region of the left third or 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.

25. A bioelectric interface as in claim 15, which further comprises at least 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 subject'"'"'s chest as verified by the appearance of a voltage at a Wilson central terminal formed by attaching summing 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 summing impedances from electrodes affixed to conventional RA, LA and LL into a “

Y”

configuration.

26. A method of defibrilating a subject comprising the steps of:

a. providing a bioelectric interface comprising an adhesive sheet in functional combination with at least two spatially separated regions of defibrillation electrodes, at least one of which spatially separated region of defibrillation electrode(s) can consist of more than one electrode, there being perforations, or functional equivalent, in said bioelectric interface, positioned to allow easy detachment of at least one of said spatially separated regions of defibrilation electrodes, which adhesive sheet presents with essentially anisotropic specific impedance properties but essentially isotropic mechanical properties, said spatially separated regions of defibrillation 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 defibrillation electrode(s) directly through the thickness of said adhesive sheet, is less than that between any two electrodes in different spatially separated regions of said defibrillation 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 with 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 material, such that adhesive material in one channel region does not contact that in other regions; and

/or

slits therein, which slits are positioned between electrodes;

in which bioelectric interface the number of regions of electrode(s) is at least nine, nine of said at least 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 subject'"'"'s chest during use as follows;

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

electrode region LA generally in the region of the left third or 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 subject and causing the defibrillation electrodes therein to be electrically attached to a defibrillation system and applying a defibrilating shock therewith through said defibrillation electrodes.

28. A method of defibrilating a subject as in claim 26, which further comprises the simultaneously step of causing at least some some of said electrodes to have a multiple component configuration.

29. A method of performing defibrillation comprising the steps of:

a. providing a bioelectric interface comprising an adhesive sheet in functional combination with at l-east two spatially separated defibrillation electrodes, there being perforations, or functional equivalent, in said bioelectric interface, positioned to allow easy detachment of at least one of said spatially separated defibrilation electrodes, which adhesive sheet presents with essentially anisotropic specific impedance properties but essentially isotropic mechanical properties, said defibrialtion 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 the thickness of said adhesive sheet, is less than that between any two of said electrodes through said adhesive sheet;

b. affixing said bioelectric interface to a subject'"'"'s chest or back, and causing said defibrillation electrodes to be connected to a defibrillation system and causing said defibrillation system to deliver a defibrillation shock therethrough.

30. A method of performing defibrillation claim 29, which further comprises the step of performing a procedure selected from the group consisting of;

a. cardiopulmonary resuscitation

b. ECG monitoring;

c. cardiac pacing;

d. electro surgery;

e. electro-ablation;

f. impedance cardiography;

g. transdermal drug or nutrient transfer; and

h. electromechanical energy transfer or detection.

31. A method of performing defibrillation as in claim 29, which further comprises the simultaneous step of causing at least some of said electrodes to have a multiple component configuration.

32. A bioelectric interface comprising a support sheet to which are affixed at least two (2) defibrillation electrodes, 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 summing impedances from each thereof, which summing impedances are “

Y”

interconnected to provide a Wilson central terminal, form an Einthoven frontal lead triangle with a I, II, III lead pattern when mounted to a subject'"'"'s chest, said Einthoven frontal lead triangle with a I, II, III lead pattern being positioned on said subject'"'"'s chest so as to provide a voltage which presents at said Wilson central terminal which is within some selected range of deviation from a voltage which would appear at a Wilson central terminal formed from summing impedances from conventional limb mounted electrodes which are “

Y”

interconnected;

said bioelectric interface further comprising;

a. an adhesive sheet is affixed to said support sheet on a subject contacting side thereof and simultaneously presents with essentially anisotropic impedance properties and essentially isotropic mechanical pliability and adhesion properties, said electrodes being affixed to said adhesive sheet such that the impedance from each said electrode directly through the thickness of said adhesive sheet, is less than that between any two of said electrodes through said adhesive sheet; and

/or

b. perforations are present in said support sheet which allow easy detachment and deployment of at least one of said Einthoven frontal lead triangle RA, LA and LL electrodes, so that said at least one of said Einthoven triangle 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; and

/or

c. an undulated outer edge on said bioelectric interface support sheet; and

/or

d. at least one hole through said bioelectric interface support sheet which allows access to the skin of a subject to which it is affixed in use;

there being perforations, or functional equivalent, in said bioelectric interface, positioned to allow easy detachment of at least one of said spatially separated defibrillation electrodes.

33. A bioelectric interface 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 first second intercostal space to the right of the sternum;

said electrode LA being generally in the region of the left third or 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 as in claim 32 which comprises said RA, LA, LL electrodes, and further comprises V1, V2, V3, V4, V5, V6 twelve lead electrocardiogram system electrode pattern, such that said electrode(s) are positioned on a subject'"'"'s chest during use as follows:

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

electrode region LA generally in the region of the left third or 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.

35. A bioelectric interface as in claim 32, in which is present at least one hole through said bioelectric interface support sheet which allows access to the skin of a subject to which it is affixed in use, one of said said at least one hole(s) being oriented so as to allow access to the sternum process of a subject to which said bioelectric interface is applied in use.

36. A bioelectric interface as in claim 32, which is further characterized by:

a. an adhesive sheet is affixed to said support sheet on a subject contacting side thereof and simultaneously presents with essentially anisotropic impedance properties and essentially isotropic mechanical pliability and adhesion properties, said electrodes being affixed to said adhesive sheet such that the impedance from each said electrode directly through the thickness of said adhesive sheet, is less than that between any two of said electrodes through said adhesive sheet; and

/or

b. perforations in said support sheet which allow easy detachment and deployment of at least one of said Einthoven frontal lead triangle RA, LA and LL electrodes, so that said at least one of said Einthoven triangle 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; and

/or

c. an undulated outer edge on said bioelectric interface support sheet; and

/or

d. at least one hole through said bioelectric interface support sheet which allows access to the skin of a subject to which it is affixed in use.

37. A bioelectric interface as in claim 32, which is further characterized by:

a. at least one said electrocardiogram system electrode which comprises spring-loaded means on a non-subject contacting side thereof, which spring-loaded means develops compression derived force when caused to be compressed, the purpose thereof being to facilitate electrical contact to an electrically conductive element caused to be placed in contact therewith in use, by development of said compression derived force.

38. A bioelectric interface as in claim 32, in which at least one of said at least three (3) spatially separated electrocardiogram system electrodes is of a construction such that there is present a “

cocklebur-like”

structure means at a subject contacting side thereof, said “

cocklebur-like”

structure means serving to effect improved electrical contact to a subject in use.

39. A bioelectric interface comprising at least two defibrillation electrodes as an integral part thereof, at least one of which defibrillation electrode(s) can consist of more than one electrode, said at least two defibrillation electrodes being affixed in an adhesive sheet which simultaneously presents with essentially anisotropic specific impedance properties and essentially isotropic pliability and adhesion mechanical properties, said at least two electrode(s) being spatially separated and 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 between said electrodes through said adhesive sheet, is greater than that straight through said adhesive sheet;

the improvement being that there are perforations, or functional equivalent, in said bioelectric interface, positioned to allow easy detachment of at least one of said defibrillation electrodes from the other of said at least two defibrillation electrodes.

40. A bioelectric interface comprising two defibrillation electrodes as an integral part thereof as in claim 39, said bioelectric interface further comprising sufficient precordial electrodes to monitor twelve lead ECG'"'"'s.

41. A bioelectric interface comprising two defibrillation electodes as in claim 40, which further comprises an ECG monitor system to which said precordial electrodes are connected.

42. A bioelectric interface as in claim 39, in which two of the at least two defibrillation electrodes have affixed thereto electrodes appropriate for use in forming right-arm (RA) and left-leg (LL) limb leads.

43. A bioelectric interface as in claim 39, which further comprises a (RA) ECG limb lead forming electrode, which in combination with two of said at least two defibrillation electrodes which are positioned appropriately to serve as LA and LL electrodes, forms an RA, LA, LL electrocardiogram system electrode pattern, which RA, LA and LL electrodes, when functionally combined with summing impedances from each thereof, which summing impedances are “

Y”

interconnected to provide a Wilson central terminal, form an Einthoven frontal lead triangle with a I, II, III lead pattern when mounted to a subject'"'"'s chest.

44. A bioelectric interface comprising two defibrillation electodes as in claim 43, which further comprises an ECG monitor system to which said limb lead electrodes are connected.

45. A bioelectric interface as in claim 39, which further comprises a harness thereon to which is affixed, in use, a bundle of wires, said bundle of wires providing separate electrical contact to said at least two defibrillation electrodes.

46. A bioelectric interface comprising two defibrillation electodes as in claim 39, which further comprises a source of defibrillation shock energy to which said two defibrillation electodes are connected.

47. A combination of two defibrillation electrodes and a bioelectric interface which comprises a support sheet in which are affixed sufficient precordial and limb lead forming electrodes to enable twelve lead ECG monitoring, said bioelectric interface having an undulated outer edge, the shape of which substantially matches the shape of said defibrillation electrodes along a locus at which said bioelectric interface and said defibrillation electrodes closely mate to one another.

48. A combination of two defibrillation electrodes and a bioelectric interface as in claim 47, in which the support sheet has at least one hole therein.