Portable device for sensing cardiac function and automatically delivering electrical therapy

• US 4,928,690 A
• Filed: 04/25/1988
• Issued: 05/29/1990
• Est. Priority Date: 04/25/1988
• Status: Expired due to Term

• Current Assignee: Zoll Medical Corporation (Asahi Kasei Corporation)
• Original Assignee: Zoll Lifecor Corporation (Asahi Kasei Corporation)
• Inventors: Russial, Joseph F., Heilman, Marlin S., Bowling, Larry D., Brandt, Arlan J.
• Primary Examiner(s): Jaworski, Francis
• Assistant Examiner(s): Manuel, George
• Application Number:
  US07/185,781
• Time in Patent Office: 764 Days
• Field of Search: 128/419 D, 128/419 P, 128/419 PG, 128/421, 128/696, 128/702
• US Class Current: 607/4
• CPC Class Codes: A61B 5/0006 ECG or EEG signals
• CPC Class Codes: A61B 5/6831 Straps, bands or harnesses
• CPC Class Codes: A61N 1/3904 External heart defibrillators [EHD]

Abstract

A patient-worn harness or vest protects at-risk patients from the possibly fatal results of heart arrhythmias. The harness or vest incorporates sensing electrodes for monitoring heart condition, a microprocessor and memory for processing signals received from the sending electrodes and comparing same with patient'"'"'s data, and skin-contacting pulsing electrodes for applying electrical pulses to the patient'"'"'s chest wall responsive to signals received from the microprocessor. The electrodes include automatic tightening and electrolyte gel release mechanisms for reducing impedance at the electrode-skin interface. A servicing subsystem is provided for the harness or vest and may be used to interface with the harness or vest and also to communicate with remote health care personnel through a suitable telephone link.

Claims

1. A patient-worn device for automatically delivering electrical therapy to the heart upon the occurrence of a treatable heart arrhythmia, the device comprising:

monitoring means for continuously sensing the patient'"'"'s heart condition, skin-contacting treatment electrode means having a surface adapted for contact with the patient'"'"'s skin, a source of electrical energy for supplying electrical pulses to the electrode means, discrimination means for receiving signals from the monitoring means and determining the presence of a treatable heart arrhythmia, impedance reducing means associated with the electrode means for actuation by the discrimination means responsive to the detection of a treatable heart arrhythmia for automatically reducing the impedance to electrical current flow at an interface between said surface of the electrode means and the patient'"'"'s skin, and switching means actuated by the discrimination means responsive to the detection of a treatable arrhythmia for connecting the source of electrical energy to the electrode means thereby applying appropriate electrical pulses to the heart.

2. The invention as defined in claim 1 wherein the electrode means is mounted on carrier means in the form of an upper body harness or garment to be worn by the patient and the impedance reducing means includes means for tightening the carrier means about the patient.

3. The invention as defined in claim 1 wherein includes a source of electrically conductive fluid material and wherein the impedance reducing means includes means for releasing the electrically conductive material from said source and delivering same to said surface of the electrode means.

4. The invention as defined in claim 1 wherein the device is in the form of a body harness which includes a chest-encompassing belt and an over-the-shoulder strap, wherein the monitoring means includes at least one monitor on each of said belt and said strap, and wherein the electrode means includes at least one pulsing electrode on each of said belt and said strap.

5. The invention as defined in claim 4 in combination with an undergarment over which the device is to be worn, the undergarment including apertures for the monitors and electrodes.

6. The invention as defined in claim 4 wherein the harness comprises elastic material and is length-adjustable.

7. The invention as defined in claim 4 wherein the chest belt includes means for measuring chest movement of respiration.

8. The invention as defined in claim 1 wherein the device comprises a vest, a subassembly including the electrode means, the discrimination means and conductor means connecting the electrode means with the discrimination means, and means for releasably securing the subassembly on the vest.

9. The invention as defined in claim 8 wherein the means for releasably securing the subassembly on the vest includes pocket means in the vest for receiving and retaining the electrode means.

10. The invention as defined in claim 9 wherein the impedance reducing means includes means for expanding the electrode means within the pocket means for applying the electrode means with increased pressure against the patient'"'"'s skin.

11. The invention as defined in claim 1 which includes signal generating means actuated by the discrimination means responsive to detection of a treatable arrhythmia for warning the patient, and a patient-activated switch means adapted to be activated by the patient for delaying the connection of the energy source to the electrode means.

12. The invention as defined in claim 11 wherein said switch means comprises two switches, both of which must be activated to delay such connection.

13. The invention as defined in claim 1 which includes an automatic voice signal generating means actuated by the discrimination means for advising the patient of information pertinent to the detection of a treatable arrhythmia.

14. The invention as defined in claim 13 wherein the generating means is adapted to deliver a warning of an impending high energy shock.

15. The invention as defined in claim 1 wherein the discriminating means includes memory for converting signals received from the monitoring means indicative of an excessively fast heart rate into a command for the energy source to supply high energy shock treatment to the heart through the electrode means.

16. The invention as defined in claim 1 wherein the discrimination means includes memory means for converting signals received from the monitoring means indicative of an excessively slow heart rate into a command for the energy source to supply pacing pulses to the heart through the electrode means.

17. The device as defined in claim 1 in combination with a maintenance subsystem having signal receiving and delivering means for interfacing with the monitoring means and the electrode means for providing at least one of the following functions, namely:

a. automatic testing of the monitoring means with calibrated input signals;

b. receiving data from a memory forming part of the discriminating means;

c. testing and recharging of the source of electrical energy;

d. transmitting memory data and sensed detection signals by telephone;

e. allowing remote health care personnel to communicate by telephone with the patient to operate the patient-worn device; and

f. serving as a high-volume memory storage element for patient and device data.

18. The invention as defined in claim 17 wherein the device comprises a carrier means in the form of an upper body harness or garment and the subsystem is in the form of a support for receipt of the carrier means thereon in a position such that the signal receiving and delivery means on the support registers with the monitoring means and electrode means on the harness.

19. An automatic system for applying electrical therapy to the heart, the system comprising:

a patient-worn subsystem and a maintenance subsystem for the patient-worn subsystem, the patient-worn subsystem including skin-contacting monitoring means for continuously accessing the patient'"'"'s heart condition, discrimination means including an electrical memory, for receiving signals from the monitoring means and determining the presence of a treatable heart arrhythmia from information stored in the memory, skin-contacting treatment electrode means having a surface adapted to contact the patient'"'"'s skin, a source of electrical energy, and switching means actuated by the discrimination means for connecting the source of electrical energy to the patient'"'"'s heart through the treatment electrode means in response to the detection of a treatable arrhythmia, the maintenance subsystem including means for interfacing with the monitoring means and electrode means when the patient worn subsystem is removed from a patient, means for testing operational status of the patient-worn subsystem and means for recording and storing contents of the memory of the patient-worn subsystem.

20. The system as defined in claim 19 wherein the patient-worn subsystem includes impedance reducing means actuated by the discrimination means for reducing impedance to electrical flow at an interface between the patient'"'"'s skin and the electrode means responsive to detection of a treatable arrhythmia.

21. The system as defined in claim 19 wherein the maintenance subsystem includes means for transmitting data, such as the memory contents, and patient arrhythmia detection signals via telephone to a remote health care facility.

22. A patient-worn device for detecting a treatable heart arrhythmia and providing electrical treatment responsive thereto, the device being in the form of a body harness or vest which includes skin-contacting monitoring means adapted to contact a patient'"'"'s skin for continuously monitoring heart rate, a source of electrical energy, skin-contacting electrode means adapted to contact the patient'"'"'s skin, discrimination means for receiving signals from the monitoring means and comparing the signals with information in a memory to determine the presence of a treatable arrhythmia, switching means actuated by the discrimination means in response to determination of a treatable arrhythmia for connecting the source of electrical energy to the electrode means so as to apply appropriate electrical pacing to the heart, and impedance reducing means associated with the electrode means for actuation by the discrimination means in response to said determination for reducing impedance to electrical current flow at an interface of the patient'"'"'s skin and the electrode means.

23. A device as defined in claim 22 wherein the discrimination means includes means for detecting heart rates below a preset value and the source of electrical energy includes means to apply pacing pulses to the electrode means for raising the heart rate.

24. The invention as defined in claim 22 wherein the discrimination means includes means for detecting heart rates above a preset value and the source of electrical energy includes means to apply a defibrillating pulse to the electrode means for effecting defibrillation.

25. The invention as defined in claim 22 wherein the body harness or vest includes tightening means for tightening same against the patient'"'"'s skin, and a source of conductive fluid, and wherein the impedance reducing means includes means for applying the tightening means so as to increase pressure between the electrode means and the patient'"'"'s skin, and the impedance reducing means further includes means for delivering the conductive fluid from the source to said interface.

26. The invention as defined in claim 25 wherein the impedance reducing means includes a common actuator means operated by the discrimination means for applying the tightening means and for delivering the conductive fluid.

27. The invention as defined in claim 26 including spring biasing means for urging the actuator means toward a tightening means-applying and conductive fluid-delivering position, restraining means for preventing the spring biasing means from urging the actuator means toward said position and trigger means operated by the discrimination means for releasing the restraining means.

28. The means as defined in claim 27 wherein the restraining means includes a heat destructable element and the trigger means includes heating means for destroying said element and thereby releasing the spring biasing means.

29. The invention as defined in claim 27, wherein the source comprises at least one squeezable fluid capsule and duct means connecting the capsule to a skin-contacting surface electrode means, and wherein the actuator means embraces the capsule for movement therealong by the spring biasing means so as to squeeze fluid from the capsule through the duct means.

30. The invention as defined in claim 27 including channel means in said surface of the electrode means for receiving fluid from the duct means.

31. The invention as defined in claim 27 wherein the actuator means includes plural actuators and the spring biasing means urges the actuators apart to apply a tightening force to the harness or vest.

32. The invention as defined in claim 22 in combination with a testing and servicing subsystem having signal receiving and delivery means adapted to interface with the monitoring means and electrode means, and microprocessing means for use in conjunction with the signal receiving and delivering means to provide servicing and testing functions for the device.

33. The invention as defined in claim 32 wherein the subsystem is contained in a stand for receiving the harness with the signal receiving and delivery means in registration with the monitoring means and electrode means.

34. The invention as defined in claim 22 wherein the electrode means is receivable with pocket means in the body harness or vest and wherein the impedance reducing means includes expander means for expanding the electrode means within the pocket means so as apply increased pressure against the patient'"'"'s skin.

35. The invention as defined in claim 34 wherein the impedance reducing means further includes chamber means in the electrode means for a capsule of conductive fluid, conduit means leading from the chamber means to said interface and puncture means operated by the expander means for puncturing a capsule in the chamber means responsive to expansion of the electrode means.

36. The invention as defined in claim 35 wherein the electrode means includes a top plate, a compression plate forming an upper wall of the chamber means and a chamber base plate, wherein the puncture means is connected with the compression plate and wherein the expander means comprises an expansion spring for separating the top plate from the compression plate, thereby expanding the electrode means, causing the puncture means to puncture a capsule in the chamber means, and causing the capsule to be squeezed between the compression plate and the base plate so as to supply fluid to the interface through the conduit means.

37. An electrode assembly for use in a patient-worn body harness or vest for applying electrical energy pulses externally to the patient in the treatment of a heart arrhythmia, the assembly including a pulsing electrode having a skin-contacting surface adapted to contact the patient'"'"'s skin, at least one squeezable capsule containing a conductive electrode fluid, duct means connecting said capsule to said surface of the electrode, a first actuator embracing the capsule, a second actuator, a spring-biasing means for urging the actuators apart, connectors for attaching the actuators to the harness whereby movement apart of the actuators by the spring biasing means provides a tightening force on the harness for increasing pressure between said surface and the patient'"'"'s skin, and further provides movement of the first actuator along the capsule to squeeze fluid through the duct means and deliver same to the said surface, restraining means for preventing the spring biasing means from moving the actuators apart, and trigger means for releasing the restraining means.

38. The invention as defined in claim 37 including a second squeezable fluid capsule embraced by the second actuator, and further duct means connecting the second capsule to said surface of the electrode for the delivery of fluid thereto by movement of the second actuator along the fluid capsule.

39. The invention as defined in claim 38 including channels in the surface of the electrode for spreading fluid received through the duct means across said surface.

40. The invention as defined in claim 37 wherein the restraining means includes a heat destructable element and the trigger means includes a heater means for destroying said element.

41. The invention as defined in claim 37 including an aperture in said surface of the pulsing electrode and a sensing electrode located in said aperture.

42. An electrode assembly for use in a body harness or vest to be worn by a patient for applying electrical energy pulses externally to the patient in the treatment of a heart arrhythmia, the assembly including a pulsing electrode having a skin contacting surface adapted to contact the patient'"'"'s skin, means defining a chamber within the assembly for a capsule of an electrically conducting fluid, the assembly having a cover portion remote from said skin contacting surface, a puncture means for puncturing a capsule within the chamber conduit means connecting the chamber with said skin contacting surface, pressure means for squeezing the capsule, and expander means for moving the cover portion away from said skin contacting surface, so as to increase the height of the assembly, while simultaneously operating the puncture means and the pressure means.

43. The invention as defined in claim 42 wherein the pressure means comprises a pressure plate forming an upper wall of the chamber and to which the puncture means is attached, and wherein the expander means comprises an expansion spring for separating the pressure plate and cover portion thereby increasing the height of the assembly while decreasing the height of the chamber and squeezing the capsule.

44. The invention as defined in claim 43 wherein the puncture means includes a curved needle carried by the pressure plate for puncturing the capsule from below on downward movement of the pressure plate.

45. The invention as defined in claim 42 in combination with a body harness or vest which includes pocket means for receipt of the assembly and pocket closure means for releasably encapsulating the assembly in the pocket means.

46. The invention as defined in claim 45 wherein the expander means comprises an expandable pneumatic chamber means within the electrode assembly and a source of fluid pressure for supplying fluid to said chamber means whereby the chamber means is expanded upon the detection of a treatable arrhythmia.

47. The invention as defined in claim 46 wherein said source is contained within the electrode assembly.

48. The invention as defined in claim 46 wherein said source is supported on a belt or harness adapted to be worn by the patient.

49. The invention as defined in claim 46 wherein the pneumatic chamber means has an expansion dimension sufficient to take up a maximum slack dimension of the vest or harness with a safety margin.

50. The invention as defined in claim 46 which includes a maintenance subsystem for use with the vest or harness, said maintenance subsystem including a pneumatic connection permitting periodic inflation of the chamber means to ensure correct harness adjustment, and adequate expansion and leak-tight integrity of the chamber means.

51. The invention as defined in claim 46 wherein the puncture means comprises means for heating a capsule in the chamber means so as to heat-rupture the capsule.