Physiological electrode systems

• US 4,419,998 A
• Filed: 08/08/1980
• Issued: 12/13/1983
• Est. Priority Date: 08/08/1980
• Status: Expired due to Term

• Current Assignee: R2 Medical Systems, Inc. (Kimberly-Clark Corporation)
• Original Assignee: R2 Corporation
• Inventors: Heath, Roger L.
• Primary Examiner(s): Kamm, William E.
• Application Number:
  US06/176,270
• Time in Patent Office: 1,222 Days
• Field of Search: 128/639, 128/640, 128/641, 128/643, 128/644, 128/783, 128/798, 128/799, 128/802, 128/803, 128/804
• US Class Current: 600/391
• CPC Class Codes: A61B 18/16 Indifferent or passive electrodes for grounding
• CPC Class Codes: A61N 1/046 Specially adapted for shock therapy, e.g. defibrillation
• CPC Class Codes: A61N 1/048 Electrodes characterised by a specific connection between lead and electrode
• CPC Class Codes: A61N 1/0488 Details about the lead
• CPC Class Codes: A61N 1/0492 Patch electrodes A61N1/0412, A61N1/0428 take precedence
• CPC Class Codes: A61N 1/3931 Protecting, e.g. back-up systems
• CPC Class Codes: G09B 23/286 for scanning or photography techniques, e.g. X-rays, ultrasonics

Abstract

Physiological electrode systems are based upon the utilization of a single pair of electrode elements to provide for physiological function monitoring of a patient, electrical stimulation of the patient, and electrical therapeutic treatment of the patient. The monitoring instrument, the stimulating instrument and the therapeutic instrument may be connected to the electrode elements separately or in various combinations. Preferably, the electrode elements are provided as a disposable set which are connected to the various instruments through appropriate cables. These cables may be interrelated to permit combinations of the instruments to be simultaneously connected to the electrode elements, with suitable protection being provided to prevent the instruments from adversely affecting one another. Aspects of the cables and electrode sets may be utilized to provide separate monitoring, stimulating and therapeutic electrode systems. An electrode element structure employing tin and stannous chloride provides system and individual function benefits.

Claims

1. A physiological electrode system for use in conveying electrical signals to and from between the human body and certain electrical devices comprising:

a first non-invasive electrode element to be attached to the skin of a patient;

a second non-invasive electrode element to be attached to the skin of the patient, said first and second electrode elements capable of producing desired operation of each of a monitoring device, a stimulating device and a therapeutic device;

interrelating means for selectively separately connecting said electrode elements to a monitoring device, a stimulating device or a therapeutic device to produce desired operation of each such device through said electrode elements, the monitoring device, the stimulating device and the therapeutic device being otherwise separate and unrelated, said interrelating means providing for the simultaneous connection of said electrode elements to at least two of said devices; and

protective means associated with said interrelating means for selectively permitting desired combinations of the monitoring device, the stimulating device and the therapeutic device to be simultaneously connected to the patient solely through said first and second electrode elements.

2. A physiological electrode system as claimed in claim 1 wherein said first and second electrode elements are disposable.

3. A physiological electrode system as claimed in claim 2 wherein each of said disposable electrode elements comprises:

an electrically conductive plate sufficiently thin to have enough flexibility to permit said conductive plate to substantially conform to the area of the patient'"'"'s body to which it is attached;

an electrically conductive medium to be located between said conductive plate and the skin of the patient to enhance electrical energy transfer between the patient and said conductive plate;

an outer surface of said conductive plate being formed of an electrically conductive metal;

a chloride of said electrically conductive metal located to be between said metal and the skin of the patient; and

adhesive means for releasably attaching the disposable electrode element to the patient.

4. A physiological electrode system as claimed in claim 3 wherein:

said electrically conductive metal is tin; and

said chloride in stannous chloride.

5. A physiological electrode system as claimed in claim 1 wherein said interrelating means comprises:

connecting plug means;

a first electrically conducting line connected between said first electrode element and said connecting plug means; and

a second electrically conducting line connected between said second electrode element and said connecting plug means.

6. A physiological electrode system as claimed in claim 5 wherein said connecting plug means comprises a unitary connecting plug and said connecting plug, said first and second conducting lines and said first and second electrode elements constitute a disposable electrode set.

7. A physiological electrode system as claimed in claim 5 wherein:

said first electrode element is approximately eight centimeters in diameter and said second electrode element is approximately twelve centimeters in diameter; and

said first electrode element is attached to the front of the patient and said second electrode is attached to the back of the patient.

8. A physiological electrode system as claimed in claim 5 wherein the stimulating device is a defibrillator and said interrelating means further comprises:

a defibrillator cable having a first end to be connected to the defibrillator;

a defibrillator electrode connector secured to the other end of said defibrillator cable and adapted to engage said connecting plug means; and

defibrillator discharge control means to permit an operator to cause a pulse of defibrillating energy to be passed to the patient through said defibrillator cable when desired.

9. A physiological electrode system as claimed in claim 8 wherein said defibrillator discharge control means comprises a discharge control module connected in said defibrillator cable.

10. A physiological electrode system as claimed in claim 9 wherein said discharge control module comprises four plunger actuated switches, application of a defibrillation pulse to the patient being achieved only upon actuation of all four switches by depression of the plunger actuators.

11. A physiological electrode system as claimed in claim 8 wherein the monitoring device is an ECG and said discharge control means comprises electrical connecting means to provide for the connection of the ECG to said defibrillator cable, said interrelating means further comprising:

an ECG cable having one end to be connected to the ECG;

an ECG electrode connector secured to the other end of said ECG cable and adapted to engage said electrical connecting means; and

a body tissue impedance simulating circuit to permit said first and second electrode elements to provide input information to the ECG from the patient that normally requires the use of a minimum of three separate electrodes.

12. A physiological electrode system as claimed in claim 11 wherein:

said defibrillator discharge control means comprises a discharge control module connected in said defibrillator cable; and

said discharge control module includes said electrical connecting means to engage said ECG connector to connect the patient to the ECG through said defibrillator cable.

13. A physiological electrode system as claimed in claim 12 wherein said protective means comprises a high voltage protection circuit between the ECG and said defibrillator cable to prevent defibrillating pulses from damaging the ECG.

14. A physiological electrode system as claimed in claim 12 wherein said electrical connecting means is adapted to engage a telemetry connector to permit transmission of ECG signals to a distant location.

15. A physiological electrode system as claimed in claim 8 wherein:

a paddle adapter is provided for permitting use of said first and second electrode elements for defibrillation with a defibrillator having conventional paddles;

said adapter has a pair of electrically conducting plates to be contacted by the defibrillator paddles; and

the first end of said defibrillator cable is connected to said adapter rather than the defibrillator to receive defibrillation pulses from said conducting plates.

16. A physiological electrode system as claimed in claim 5 wherein the therapeutic device is an ESU and said interrelating means further comprises:

an ESU cable having one end to be connected to the ESU; and

an ESU electrode connector secured to the other end of said ESU cable and adapted to engage said connecting plug means.

17. A physiological electrode system as claimed in claim 16 wherein said protective means comprises capacitive coupling means connecting said second conducting line to said conducting leads in said ESU cable to provide a return path for the ESU signals, to protect the ESU from stimulating device energy pulses, and to protect the patient from shock currents.

18. A physiological electrode system as claimed in claim 17 wherein said capacitive coupling means also connects said first conducting line to said conducting leads in said ESU cable.

19. A physiological electrode system as claimed in claim 16 wherein the monitoring unit is an ECG and said interrelating means further comprises:

an ESU cable connector in said ESU cable intermediate the ESU and said ESU electrode connector;

an ECG cable having one end to be connected to the ECG;

an ECG electrode connector secured to the other end of said ECG cable and adapted to engage said ESU cable connector;

a body tissue impedance simulating circuit between said ESU cable and the ECG to permit said first and second electrode elements to provide input information to the ECG from the patient that normally requires the use of a minimum of three separate electrodes; and

a low pass filter connected between said ESU cable and the ECG to prevent ESU signals from reaching the ECG without significantly affecting the ECG signals.

30. A physiological electrode system as claimed in any of claims 8-29 wherein said defibrillator electrode connector comprises:

a first receptacle for engaging said plug means, said first receptacle being connected to leads in said defibrillator cable carrying defibrillating energy; and

a second ECG-only receptacle for engaging ECG plug means, said ECG plug means connected to electrode elements adapted only for ECG monitoring, and said second receptacle being connected to an ECG through conductive leads other than the leads carrying defibrillating energy.

20. A physiological electrode system comprising:

a first electrode element to be attached to a patient;

a second electrode element to be attached to the patient;

interrelating means providing the capability for selectively connecting said electrode elements to an ECG, a stimulating device and a therapeutic device to produce desired operation of each such device through said electrode elements, the ECG, the stimulating device and the therapeutic device being otherwise separate and unrelated, said interrelating means comprising;

connecting plug means;

a first electrically conducting line connected between said first electrode element and said connecting plug means;

a second electrically conducting line connected between said second electrode element and said connecting plug means;

an ECG cable having one end to be connected to the ECG;

an ECG electrode connector secured to the other end of said ECG cable and adapted to engage said connecting plug means; and

a body tissue impedance simulating circuit to permit said first and second electrode elements to provide input information to the ECG from the patient that normally requires the use of a minimum of three separate electrodes; and

protective means associated with said interrelating means for selectively permitting desired combinations of the ECG, the stimulating device and the therapeutic device to be simultaneously connected to the patient solely through said first and second electrode elements.

21. A physiological electrode system as claimed in claim 20 wherein said protective means comprises:

a low pass filter network to reduce high frequency interference passing through said ECG cable; and

a high voltage protection circuit to prevent large currents from the stimulating device from passing through the ECG cable in order to protect the ECG and to reduce energy loss.

22. A physiological electrode system as claimed in claim 21 wherein said high voltage protection circuit comprises series resistance.

23. A physiological electrode system as claimed in claim 21 wherein said low pass filter network includes DC offset compensation means.

24. A physiological electrode system as claimed in claim 23 wherein said DC offset compensation means comprises a resistor connected across the inputs to the ECG.

25. A physiological electrode system comprising:

a first electrode element to be attached to a patient;

a second electrode element to be attached to the patient;

interrelating means providing the capability for selectively connecting said electrode elements to a monitoring device, a defibrillator and a therapeutic device to produce desired operation of each such device through said electrode elements, the monitoring device, the defibrillator and the therapeutic device being otherwise separate and unrelated, said interrelating means comprising;

connecting plug means;

a first electrically conducting line connected between said first electrode element and said connecting plug means;

a second electrically conducting line connected between said second electrode element and said connecting plug means;

a defibrillator cable having a first end to be connected to the defibrillator;

a defibrillator electrode connector secured to the other end of said defibrillator cable and adapted to engage said connecting plug means; and

defibrillator discharge control means to permit an operator to cause a pulse of defibrillating energy to be passed to the patient through said defibrillator cable when desired;

protective means associated with said interrelating means for selectively permitting desired combinations of the monitoring device, the defibrillator and the therapeutic device to be simultaneously connected to the patient solely through said first and second electrode elements;

a paddle adapter provided for permitting use of said first and second electrode elements for defibrillation with a defibrillator having conventional paddles, said adapter having a pair of electrically conducting plates to be contacted by the defibrillator paddles, the first end of said defibrillator cable connected to said adapter rather than the defibrillator to receive defibrillation pulses from said conducting plates; and

an audible alarm arrangement to indicate to an operator that the paddles are in proper contact with said plates to pass a defibrillator pulse to said defibrillator cable and to warn personnel to get away from the patient.

26. A physiological electrode system as claimed in claim 25 wherein said audible alarm arrangement comprises:

an electrically energized alarm buzzer;

a battery connected in series with said alarm buzzer to energize said alarm buzzer; and

a pair of switches connected in series with said alarm buzzer and said battery, said switches being closed by button actuators on said plates when the defibrillator paddles properly contact said plates to thereby complete the energizing circuit for said alarm buzzer.

27. A physiological electrode systems comprising:

a first electrode element to be attached to a patient;

a second electrode element to be attached to the patient;

a paddle adapter provided for permitting use of said first and second electrode elements for defibrillation with a defibrillator having conventional paddles, said adapter having a pair of electrically conducting plates to be contacted by the defibrillator paddles;

interrelating means providing the capability for selectively connecting said electrode elements to an ECG, a defibrillator and a therapeutic device to produce desired operation of each such device through said electrode elements, the ECG, the defibrillator and the therapeutic device being otherwise separate and unrelated, said interrelating means comprising;

connecting plug means;

a first electrically conducting line connected between said first electrode element and said connecting plug means;

a second electrically conducting line connected between said second electrode element and said connecting plug means;

a defibrillator cable having a first end to be connected to the defibrillator, the first end of said defibrillator cable connected to said adapter rather than the defibrillator to receive defibrillation pulses from said conducting plates;

an ECG cable having one end to be connected to the ECG and the other end connected to said adapter to obtain ECG signals through said defibrillator cable; and

a body impedance simulating circuit to permit said first and second electrode elements to provide input information to the ECG from the patient that normally requires the use of a minimum of three separate electrodes; and

protective means associated with said interrelating means for selectively permitting desired combinations of the ECG, the defibrillator and the therapeutic device to be simultaneously connected to the patient solely through said first and second electrode elements.

28. A physiological electrode system as claimed in claim 27 wherein said protective means comprises a high voltage protection circuit between the ECG and said defibrillator cable to prevent defibrillation pulses from damaging the ECG.

29. A physiological electrode system as claimed in claim 28 and further comprising electrical connecting means connected to the ECG side of said high voltage protection means to engage an ECG output connector for a second ECG or a telemetry connector for transmitting ECG signals to a distant location.

31. A physiological electrode system comprising:

a first electrode element to be attached to a patient;

a second electrode element to be attached to the patient;

interrelating means providing the capability for selectively connecting said electrode elements to a monitoring device, a stimulating device and an ESU to produce desired operation of each such device through said electrode elements, the monitoring device, the stimulating device and the ESU being otherwise separate and unrelated, said interrelating means comprising;

connecting plug means;

a first electrically conducting line connected between said first electrode element and said connecting plug means;

a second electrically conducting line connected between said second electrode element and said connecting plug means;

an ESU cable having one end to be connected to the ESU, said ESU cable including two conducting leads connected to the RF return input of the ESU;

an ESU electrode connector secured to the other end of said ESU cable and adapted to engage said connecting plug means; and

electrical conducting means in said plug means to interconnect the ends of said conducting leads when said plug means engages said ESU connector, thereby permitting the passage of a cord fault test DC current through said conducting leads to indicate that a path for the return of the RF signals to the ESU has been completed before the ESU is permitted to become operational; and

protective means associated with said interrelating means for selectively permitting desired combinations of the monitoring device, the stimulating device and the ESU to be simultaneously connected to the patient solely through said first and second electrode elements, said protective means comprising capacitive coupling means connecting said second conducting line to said conducting leads in said ESU cable to provide a return path for the ESU signals, to protect the ESU from stimulating device energy pulses, and to protect the patient from shock currents.

32. A physiological electrode system comprising:

a first non-invasive electrode element to be attached to the skin of a patient;

a second non-invasive electrode element to be attached to the skin of the patient;

a first conducting means to electrically connect said first electrode element to a first input of a physiological monitoring device;

second conducting means to electrically connect said second electrode element to a second input of the physiological monitoring device, said first and second conducting means conveying electrical signals having an information content regarding a physiological function of the patient from the patient to the physiological monitoring device;

third conducting means electrically connected to a therapeutic device;

high pass filter means connected to provide a low impedance path between said third conducting means and at least one of said first and second electrode elements for the therapeutic device signals, while providing a high impedance path for the physiological function signals;

low pass filter means connected to provide a low impedance path between the physiological monitoring device and said first and second electrode elements for the physiological function signals while providing a high impedance path for the therapeutic device signals;

fourth and fifth conducting means to connect a stimulating device to said first and second electrode elements; and

a high voltage protection circuit to prevent signals from said stimulating device from damaging the physiological monitoring device.

33. A physiological electrode system as claimed in claim 32 wherein:

the physiological monitoring device is an ECG;

the therapeutic device is an ESU; and

the stimulating device is a defibrillator.

34. A physiological electrode system providing for the connection of a monitoring device, a therapeutic device or a stimulating device to a patient through a single common instrument-to-body interface and comprsing:

first and second electrode elements to be attached to the patient'"'"'s body, said electrode elements constructed to have the characteristics required for monitoring, stimulating and therapeutic applications, including the capability of handling relatively large energy requirements for stimulating and therapeutic applications and the sensitivity to low level signals required for monitoring applications;

standardized connecting plug means;

first and second electrically conducting lines connected from said electrode elements to said connecting plug means, said electrode elements, said connecting plug means and said conducting lines constituting a disposable electrode set;

connector means to engage said connecting plug means; and

cable means electrically joined to said connector means for selectively connecting the monitoring device, the therapeutic device or the stimulating device to said electrode elements by engagement of said connector means and said connecting plug means.

35. A physiological electrode system as claimed in claim 34 wherein:

the monitoring device is an ECG;

the therapeutic device is an ESU; and

the stimulating device is a defibrillator.

36. A physiological electrode system as claimed in claim 35 wherein each of said electrode elements comprises:

an electrically conductive plate sufficiently thin to have enough flexibility to permit said conductive plate to substantially conform to the area of the patient'"'"'s body to which it is attached;

an electrically conductive medium to be located between said conductive plate and the skin of the patient to enhance electrical energy transfer between the patient and said conductive plate;

an outer surface of said conductive plate being formed of an electrically conductive metal;

a chloride of said electrically conductive metal located to be between said metal and the skin of the patient; and

adhesive means for releasably attaching the electrode element to the patient.

37. A physiological electrode system as claimed in claim 36 wherein:

said electrically conductive metal is tin; and

said chloride is stannous chloride.

38. A physiological electrode system as claimed in claim 35 wherein said cable means is an ECG cable comprising:

first and second electrically conducting leads to form a pair of continuous current-carrying paths with said first and second conducting lines, respectively, from the ECG to said electrode elements; and

a body tissue impedance simulating circuit to permit said electrode elements to provide input information to the ECG from the patient that normally requires the use of a minimum of three separate electrodes.

39. A physiological electrode system as claimed in claim 38 wherein said ECG cable further comprises:

a high voltage protection circuit; and

a low pass filter network.

40. A physiological electrode system as claimed in claim 39 wherein said body tissue simulating circuit, said high voltage protection circuit and said low pass filter netweork are located in said connector means.

41. A physiological electrode system as claimed in claim 35 wherein said cable means is an ESU cable comprising:

a first electrically conducting lead; and

capacitive coupling means between said electrically conducting lead and at least one of said first and second conducting lines to provide a path for RF signals to be returned to the ESU.

42. A physiological electrode system as claimed in claim 41 wherein said capacitive coupling extends from both said first and second conducting lines to said conducting lead.

43. A physiological electrode system as claimed in claim 42 wherein:

said ESU cable further comprises a second electrically conducting lead;

a shorting conductor is located in said plug means to short-circuit said first and second conducting leads when said connector means is engaged with said plug means to provide a path for a DC cord fault test signal; and

said capacitive coupling means is connected to both of said conducting leads.

44. A physiological electrode system as claimed in claim 35 wherein said cable means is a defibrillator cable comprising:

first and second electrically conducting leads to form a pair of continuous current-carrying paths with said first and second conducting lines, respectively, from the defibrillator to said electrode elements; and

discharge control means to permit an operator to cause a pulse of defibrillating energy to be passed to the patient through said conducting leads and said conducting lines.

45. A physiological electrode system as claimed in claim 44 wherein said discharge control means is associated with conventional defibrillator paddles and the defibrillator cable further comprises a paddle adapter to permit defibrillating energy to pass from the paddles through said conducting leads.