WO1997002068A1

WO1997002068A1 - Portable defibrillator with disposable power pack

Info

Publication number: WO1997002068A1
Application number: PCT/US1996/011259
Authority: WO
Inventors: Pierre Lamond; Bruno Strul
Original assignee: Automatic Defibrillator, Inc.
Priority date: 1995-07-03
Filing date: 1996-07-02
Publication date: 1997-01-23
Also published as: AU6451196A; US5658316A

Abstract

A portable defibrillator device has a housing including a disposable power pack and a main electronic unit. Treatment, ground pad and ECG electrodes are also included. One or more non-rechargeable batteries are positioned in the power pack, with each battery including battery contacts. An ECG detection circuit provides a control signal representative of heart activity. A defibrillation circuit is responsive to the control signal and is connected to the treatment electrode to deliver a discharge to the patient. In another embodiment, the portable defibrillator's housing includes a removable power pack and a main electronic unit. Disposed within the power pack are one or more batteries. A treatment electrode is capable of delivering a defibrillation shock and also measure ECG activity of a patient. A ground pad electrode is also included. An ECG detection circuit provides the control signal and a defibrillation circuit receives the control signal and delivers a treatment shock when appropriate. The defibrillation circuit is substantially positioned in the main electronic unit.

Description

PORTABLE DEFIBRILLATOR WTTH DISPOSABLE POWER PACK

BACKGROUND OF THE INVENTION Field ofthe Invention

This invention relates to portable defibrillator devices, and more particularly, to a portable defibrillator device that has a disposable power pack which includes non-rechargeable batteries and a memory chip.

Description of Related Art

One ofthe most common and life threatening consequences of a heart attack is the development of a cardiac arrhythmia in which the heart is unable to pump a significant volume of blood. Unless a normal heart rhythm can be restored within a few minutes serious brain damage and death may result. The most effective way to treat ventricular fibrillation is the application of an electric shock to the victim. The shock frequently terminates the chaotic activity ofthe arrhythmia and restores the normal pumping action ofthe heart. Defibrillators for producing and delivering such shocks have been known for many years. These defibrillators are usually large and relatively expensive. More recently, portable defibrillators have been introduced. However, even with the introduction of portable defibrillators, only a small percent of all ambulances are equipped with defibrillators.

Portable defibrillator devices currently available typically include rechargeable batteries. To keep them fully charged rechargeable batteries require constant maintenance. This adds to the expense ofthe portable defibrillator, and there are instances when the batteries are too low to deliver a defibrillation shock to the patient. Thus, there are safety concerns with the use of rechargeable batteries.

In other portable defibrillation devices an enable switch activates the battery pack. If one has forgotten to turn the apparatus off then the batteries are drained. Further there is no fail-safe mechanism in the event that the switch has been left on.

It is be desirable to provide a low cost portable defibrillator device which can be used in ambulances and in the home. It would also be desirable to provide a defibrillator device that has a disposable energy pack. Further, it would be desirable to provide a portable defibrillator device which includes low- cost components in a disposable energy pack, including non-rechargeable batteries and a memory chip. It would also be desirable to be provide a portable defibrillator device with a disposable energy pack that is activated when insulator strips, disposed between the non-rechargeable batteries and battery leads, are removed. It would also be desirable to include one or more memory chips in a power pack with the batteries in order to reduce loss of archival information.

SUMMARY OF THE INVENTION Accordingly, it is an object ofthe invention to provide a low cost, portable defibrillator device.

Another object ofthe invention is to provide a safe, easy to operate, low, cost portable defibrillator device.

Still a further object ofthe invention it to provide a low cost, portable defibrillator device with a disposable energy pack.

Another object ofthe invention is to provide a low cost, portable defibrillator device with non-rechargeable batteries.

A further object ofthe invention is to provide a low cost, portable defibrillator device with a disposable energy pack that contains non-rechargeable batteries and a memory chip.

Yet another object ofthe invention is to provide a low cost, portable defibrillator device includes insulation sleeves positioned between the non- rechargeable batteries and battery leads.

A further object ofthe invention is to provide a low cost, portable defibrillator device that becomes activated when an insulator sleeve positioned between battery leads and the non-rechargeable batteries is removed. Another object ofthe invention is to provide a low cost, portable defibrillator device that does not require active interaction between the defibrillator and the operator.

These and other objects ofthe invention are achieved in a portable defibrillator device that has a housing. The housing includes a disposable and removable power pack and a main electronic unit. Treatment, ground pad and ECG electrodes are used to detect and then deliver a shock to the heart if appropriate. One or more non-rechargeable batteries are positioned in the power pack. Each battery includes battery contacts. An ECG detection circuit provides a control signal that is representative of heart activity. A defibrillation circuit responds to the control signal, and is connected to deliver a discharge to the treatment electrode.

In another embodiment, the portable defibrillator device includes a housing with a removable power pack and a main electronic unit. The power pack includes one or more batteries. A treatment electrode is used that is capable of delivering a defibrillation shock and also measures ECG activity of a patient. Also included is a ground pad electrode. An ECG detection circuit provides a control signal that is representative of heart activity. A defibrillation circuit is responsive to the control signal and connected to deliver a discharge to the treatment electrode. The defibrillation circuit is substantially positioned in the main electronic unit.

One or more memory chips can be included in the power pack, and the batteries can be permanently fixed in the power pack. The main electronic unit includes a receiving slot with battery contacts that is adapted to make electrical contact with the batteries in the power pack. Removable insulators are positioned between the battery contacts ofthe receiving slot and the batteries. The batteries are electrically connected to the defibrillation circuit when the removable insulator is removed. Preferably, the batteries are non-rechargeable. The portable defibrillator can also include a battery monitoring circuit. The battery monitoring circuit is continuously connected to the batteries when the power pack is positioned in the receiving slot ofthe main electronic unit. A microprocessor is included in the defibrillation circuit. The ECG circuit includes signal conditioning and amplification circuits. The signal conditioner includes one or more filters and one or more amplifiers. The defibrillation circuit is made of a high voltage generator, an energy storage capacitor and a discharge switch. Further, the treatment and ground pad electrodes can be provided with electro-conductive gels.

BRTEF DESCRIPTION OF THE FIGI7RFS Fig. 1 is a perspective view ofthe portable defibrillator device ofthe present invention.

Fig. 2(a) is a perspective view ofthe portable defibrillator device of Fig. 1 with the power pack removed from the main housing.

Fig. 2(b) is a cross-sectional view ofthe power pack illustrated in Fig. 2(a) taken along the lines 2(b)-2(b). Fig. 3 is a schematic diagram of one embodiment ofthe electronics ofthe present invention.

Fig. 4 is a schematic diagram of a second embodiment ofthe electronics ofthe present invention.

DETAILED DESCRIPTION

Referring now to Figs 1, 2(a) and 2(b), a portable defibrillator 10 includes a main housing 12 formed of a variety of materials well known to those skilled in the art. All ofthe components of portable defibrillator 10, including electronics and power pack, can be included in housing 12. A treatment electrode 14, ground pad electrode 16 and ECG 18 electrode are all coupled to housing 12. In some instances, only ground pad electrode 16 and treatment electrode 14 are required, and the function of ECG electrode 18 is included in treatment electrode 14.

Treatment electrode 14 delivers the shock to the heart and can be made an integral part of housing 12 or ofthe power pack, and is adapted to be placed on a patient's chest to deliver a defibrillation shock to a patient when appropriate. Treatment electrode 14 is made of materials, and is of similar size, of other defibrillator electrodes used with commercially available defibrillators. Treatment electrode 14 can also include a conductive gel. The gel can be released through treatment electrode 14, on its exterior surface or applied to the patient's chest.

Ground pad electrode 16 and ECG electrode 18 are also placed on the patient. Preferably, ECG electrode 18 is placed near treatment electrode 14, and ground pad electrode 16 is positioned at another position on the patient's chest. Each of electrodes 14, 16 and 18 can connected with plugs to corresponding ports positioned on an exterior surface of housing 12. All three electrodes 14,

16 and 18 can be coated with an electro-conductive gel.

A power pack 20 is removable from housing 12. Included in power pack 20 is one or more non-rechargeable batteries, one or more memory chips 24, for built-in archival storage, memory chip contacts 25, a PC board 26 and battery contacts 28. Devices other than memory chips 24 can be utilized so long as they are capable of storing digitized ECG signals before and after application ofthe shock to the heart. Power pack 20 is disposable. The remaining electronics remain in a main electronic unit 29 included in housing 12, or alternatively in a separate module that can be part of housing 12. Power pack 20 and electrode 16 or 18 can be in one integral unit.

An instruction chart can be included on a top or side surface of main housing 12, as well as LED's and an electro-mechanical indicator advising if a shock has been sent to the patient. Further labeling can be applied to the outside of power pack 20. Power pack 20, with or without one or more electrodes 14, 16 or 18, is sealed in standard insulating packaging material, such as electrical insulator 30. Electrical insulator 30 can be the backing for electrodes 14, 16 or 18. Power pack 20 is positioned in a receiving slot 32, defined by main housing 12. Electrical insulator 30 is positioned between battery contacts 28 and battery contacts 34 and 36. When positioned between opposing battery contacts, electrical insulator 30 precludes the completion of a circuit, and thus permits the practical use of non-rechargeable batteries.

When electrical insulator 30 is removed, electrodes 14, 16 and 18 are ready for attachment, and the batteries are then electrically connected to main electronic unit 29. Power pack 20 is guaranteed for single use until its expiration date. For purposes of this disclosure, single use is defined as an ability to deliver the minimum number of shocks at the prescribed level by AMI guidelines. AAMI standard, Association for the Advancement of Medical Instrumentation, "Automatic external defibrillators and remote-control defibrillators", ANSI/ AAMI DF39- 1993 , this document is herein incoφorated by reference.

Power pack 20 may not be salvageable once electrical insulator 30 is removed. At this point, it is then necessary to replace power pack 20.

A monitoring circuit periodically monitors the functionality of main electronic unit 29. If main electronic unit fails any test than monitoring circuit sends a visual or audible warning signal.

Treatment electrode 14 is positioned on an exterior surface of power pack 20. Before defibrillator device 10 is used on a patient electrical insulator is removed. This results in a completion ofthe defibrillation circuit and treatment can begin, as more fully explained hereafter. After defibrillation device 10 is used on a patient, and a shock has been successfully delivered, power pack 20 is removed from receiving slot 32 and returned for replacement. The used power pack 20 contains archival data on its internal memory chip that needs to be read by a special reader to produce a chart ofthe patient's cardiac electrical activity before and after the treatment. In one embodiment, the requirements for a one-use portable defibrillator

10 is to deliver six (6) pulses of electricity, 360 joules each, thirty seconds apart. Altogether there are 2, 160 joules. With eight D-size alkaline batteries, there are 12 volts with 2 amps/hour capacity which provide 86,400 joules.

ECG electrode 18 produces a control signal to a defibrillation circuit 38. Batteries 22 in power pack 20 are connected to a high voltage generation circuit when electrical insulator 30 is removed, in order to deliver a discharge. Treatment electrode 14 then provides a defibrillation shock in response to receipt of a control signal from a microprocessor.

When an operator decides to use defibrillator device 10 it is first used in a diagnostic mode. Defibrillator device 10 determines ifthe patient is in need of a shock. If so, then the operator pulls electrical insulator 30 to remove it. This action connects power pack 20, specifically non-rechargeable batteries 22, to defibrillation circuit 38, and defibrillation circuit 38 is activated. Non- rechargeable batteries 22 can be permanently installed in power package 20 and soldered into PC board 26. One or two enable switches 40 can be included in one or both of handles 42. ECG electrode 18 is placed into contact on the patient's chest to determine ECG activity. Ground pad electrode 16 is removed from housing 12, or power pack housing 20, and placed on the chest or on a side ofthe patient. It will be appreciated that the functions of electrodes 14 and 16 can be included in a single treatment/ECG electrode. The operator than holds housing 12 with handles 42, making sure there is good contact between treatment electrode 14 and the patient's chest at a location where the heart is. Although Figs. 1 and 2 show that two handles are included, it is possible that only one is necessary, or alternatively, the operator can apply sufficient pressure to make the intimate contact between treatment electrode 14 and the patient's chest. In any event, it is important that the operator not receive a shock when the defibrillation shock is delivered from treatment electrode 14 to the patient. For this reason, it is desirable to include two handles 42 so that the operator does not have the occasion to have one hand touching the patient when the defibrillation shock is delivered to the patient. Further one or more enable switches 40 are included and positioned adjacent to handles 42 or are directly on handles 42. Enable switches 40 provide the operator with an ability to stop the procedure for a variety of reasons, including but not limited to, (i) someone is touching the patient, (ii) the operator is touching the patient, or (iii) the patient begins to move, as well as many other instances where it is desirable for the operator to be able to stop the defibrillation process. A display can be included but is not necessary. A variety of different messages can be seen with a display. If a display is provided it can be spring loaded and activated with a solenoid. The operator does not have to provide feedback information to portable defibrillation device 10. Thus, all the operator needs to do is to remove electrical insulator 30, apply electrode 14 to the patient's chest, apply electrode 16 to the patient's chest, and then if it is appropriate, defibrillation device 10 applies the necessary defibrillation shocks if the operator activates enable switches 40. The safety ofthe operator is insured with the inclusion of handles 42. Portable defibrillator 10 can also include a monitoring circuit which is continuously connected to main electronic unit 29.

Referring to Figure 3, memory chip 24 communicates with one or more wires to main electronic unit 29. Included in main electronic unit 29 is a microprocessor 44 such as a model no. 68HC11, available from Motorola. Coupled to microprocessor 44 is a battery 46 for main electronic unit 29, and an analog front end 48 which can include one or more filters, an isolation apparatus and amplifiers, that are used for monitoring purposes for ECG electrode 18.

After electrodes 14, 16 and 18 are in place, an ECG signal is analyzed at microprocessor 44. Ifthe patient is shockable a visual and/or audio signal is sent. The visual signal can emanate from a light or an LED.

Two different embodiments ofthe electronics ofthe invention are disclosed in Figures 3 and 4. A switching regulator 50, 50' is connected to microprocessor 44 and to a transformer 52 ,52'. An output of transformer 52 is about 100 to 500 volts, and the output of 52' is about 1000 to 5000 volts. Transformers 52 and 52' transmit energy to storage capacitor 54, 54' which then creates the discharge for the shock that is delivered to the patient via electrode 14. It requires about 15 seconds to charge up capacitor 54, 54'. A voltage divider 56, 56' across capacitor 54, 54' creates a controlled feedback system where capacitor 54, 54' is charged for a voltage corresponding to a known energy level according to the formula E = CV²/2. Capacitor 54, 54' is charged to a known energy. When it is time to shock the patient a signal is sent from microprocessor 44 to a semiconductor switch 58 or switch 62. Capacitor 54, 54' then discharges through transformer 60 in Figure 3 or directly to electrode 14 in Figure 4. An alternative circuit charges capacitor 54' to 1000 to 5000 volts. A high voltage switch discharges to the patient. An algorithm is associated with microprocessor 44 which digitizes the signal received from ECG electrode 18. The ECG signal is digitized and analyzed. Energy builds up in capacitor 54, 54'. If it is determined by the analysis of ECG signal that a shock is required, then capacitor 54 discharges energy through transformer 60 to electrode 14 or from capacitor 54' directly to electrode 14. This can be repeated up to five or six times. Further, capacitor 54,

54' can be recharged to different levels by changing the voltage. This is achieved by including different tabs, coupled to voltage divider 56, 56' with controls on a front panel of housing 12.

In the embodiment of Figure 4, capacitor 54' does not discharge to a transformer. A diode 53 prevents capacitor 54' from discharging to transformer

52'.

Further details regarding the electronics and suitable software are found in U.S. Patent No. 4,610,254, incorporated herein by reference.

The foregoing description of a preferred embodiment ofthe invention has been presented for purposes of illustration and description. It is not intended to be exhaustive or to limit the invention to the precise forms disclosed. Obviously, many modifications and variations will be apparent to practitioners skilled in this art. It is intended that the scope ofthe invention be defined by the following claims and their equivalents. What is claimed is:

Claims

1. A portable defibrillator device, comprising: a housing including a disposable power pack and a main electronic unit with an ECG detection circuit that provides a control signal representative of heart activity, wherein the power pack includes an insulator member configured to be removed from the power pack to provide a coupling ofthe power pack to the main electronic unit; a treatment electrode coupled to the power pack; a ground pad electrode coupled to the power pack; an ECG electrode; one or more non-rechargeable batteries positioned in the power pack, each battery including battery contacts; and a defibrillation circuit responsive to the control signal and configured to deliver a discharge to the treatment electrode, wherein the defibrillation circuit is included as at least a part ofthe main electronic unit.

2. The portable defibrillator of claim 1, further comprising: a removable insulator positioned between battery contacts and the main electronic unit, wherein the non-rechargeable batteries are electrically connected to the defibrillation circuit when the removable insulator is removed.

3. The portable defibrillator of claim 1 , wherein the functionality of the treatment electrode and the ECG electrode are included in a single electrode.

4. The portable defibrillator of claim 1, wherein the main electronic unit includes a receiving slot with battery contacts.

5. The portable defibrillator of claim 4, wherein the power pack is removably positioned in the receiving slot.

6. The portable defibrillator of claim 5, wherein a removable insulator is positioned between the battery contacts ofthe receiving slot and the battery contacts ofthe non-rechargeable batteries.

7. The portable defibrillator of claim 1, further comprising: a battery monitoring circuit coupled to the main electronic unit.

8. The portable defibrillator of claim 7, wherein the battery monitoring circuit is continuously connected to the non-rechargeable batteries when the power pack is positioned adjacent to the main electronic unit.

9. The portable defibrillator device of claim 1, further comprising: a microprocessor coupled to the defibrillation circuit.

10. The portable defibrillator device of claim 1, wherein the ECG circuit includes a signal conditioner and an amplifier.

11. The portable defibrillator device of claim 10, wherein the signal conditioner includes one or more filters and one or more amplifiers.

12. The portable defibrillator device of claim 1, wherein the defibrillation circuit includes a high voltage generator, an energy storage capacitor and a discharge switch.

13. The portable defibrillator device of claim 6, wherein the non- rechargeable batteries are continuously connected to the battery monitoring circuit when the power pack is positioned in the housing, and the power pack is coupled to the defibrillation circuit when the insulator is removed and the power pack is positioned in the housing.

14. The portable defibrillator of claim 1, further comprising: an operator support that permits an operator ofthe portable defibrillator device to physically apply the treatment electrode when the treatment electrode is positioned on at least a portion of an exterior surface ofthe power pack to a patient and create a contact between the patient and the treatment electrode without subjecting the operator to a shock when the treatment electrode delivers a shock to the patient.

15. The portable defibrillator of claim 14, wherein the operator support includes at least one handle attached to the housing.

16. The portable defibrillator of claim 14, wherein the operator support includes at least two handles attached to the housing.

17. The portable defibrillator of claim 7, wherein the battery monitoring circuit periodically checks a status ofthe non-rechargeable batteries.

18. The portable defibrillator of claim 1, wherein the treatment electrode includes an electro-conductive gel.

19. The portable defibrillator of claim 1, wherein the ground pad electrode has an electrode surface that includes an electro-conductive gel.

20. The portable defibrillator of claim 1 , wherein the power pack includes a memory chip.

21. A portable defibrillator device, comprising: a housing including a removable power pack including one or more non- rechargeable batteries and a main electronic unit including an ECG detection circuit providing a control signal representative of heart activity, wherein the power pack includes an insulator member configured to be removed from the power pack to provide a coupling ofthe power pack to the main electronic unit; a treatment electrode configured to deliver a defibrillation shock and measure ECG activity of a patient, wherein the treatment electrode is coupled to the power pack; a ground pad electrode coupled to the power pack; a defibrillation circuit responsive to the control signal and configured to deliver a discharge to the treatment electrode, wherein at least a portion ofthe defibrillation circuit is included in the main electronic unit.

22. The portable defibrillator of claim 21, wherein the power pack includes a memory chip.

23. The portable defibrillator of claim 21 , further comprising: a separate ECG electrode, wherein the treatment electrode only delivers a defibrillation shock to the heart and the ECG electrode measures heart activity.

24. The portable defibrillator of claim 21, wherein the main electronic unit includes a receiving slot with battery contacts adapted to make electrical contact with the batteries in the power pack.

25. The portable defibrillator of claim 24, further comprising: a removable insulator positioned between the battery contacts ofthe receiving slot and the batteries, wherein the batteries are electrically connected to the defibrillation circuit when the removable insulator is removed.

26. The portable defibrillator of claim 21, wherein the batteries are non-rechargeable batteries.

27. The portable defibrillator of claim 21 , further comprising: a battery monitoring circuit coupled to the main electronic unit.

28. The portable defibrillator of claim 27, wherein the battery monitoring circuit is continuously connected to the batteries when the power pack is positioned adjacent to the main electronic unit.

29. The portable defibrillator device of claim 21, further comprising: a microprocessor included in the defibrillation circuit.

30. The portable defibrillator device of claim 21 , wherein the ECG circuit includes a signal conditioner and an amplifier.

31. The portable defibrillator device of claim 30, wherein the signal conditioner includes one or more filters and one or more amplifiers.

32. The portable defibrillator device of claim 21 , wherein the defibrillation circuit includes a high voltage generator, an energy storage capacitor and a discharge switch.

33. The portable defibrillator of claim 21 , further comprising : an operator support that permits an operator ofthe portable defibrillator device to physically apply the treatment electrode when the treatment electrode is positioned on at least a portion of an exterior surface ofthe power pack to a patient and create a contact between the patient and the treatment electrode without subjecting the operator to a shock when the treatment electrode delivers a shock to the patient.

34. The portable defibrillator of claim 33, wherein the operator support includes at least one handle attached to the housing.

35. The portable defibrillator of claim 33 , wherein the use support includes at least two handles attached to the housing.

36. The portable defibrillator of claim 33, further comprising: a defibrillation circuit enable switch positioned at one of a handles, wherein the defibrillation circuit is coupled to the main electronic unit.

37. The portable defibrillator of claim 21 , wherein the treatment electrode includes an electro-conductive gel.

38. The portable defibrillator of claim 21, wherein the ground pad electrode has an electrode surface that includes an electro-conductive gel.

39. A portable defibrillator device, comprising: a housing including a power pack; a treatment electrode coupled to the power pack; a ground pad electrode coupled to the power pack; an ECG electrode coupled to the power pack; one or more batteries positioned in the power pack, each battery including battery contacts; an ECG detection circuit configured to provide a control signal representative of heart activity; a defibrillation circuit responsive to the control signal and configured to deliver a discharge to the treatment electrode; and an memory device configured to store a digitized ECG signals before and after application of a defibrillation shock, wherein the memory device is positioned in the power pack.

40. The portable defibrillator device of claim 39, wherein the memory device is one or more memory chips.

41. A portable defibrillator device, comprising: a housing including a power pack; a treatment electrode coupled to the power pack; a ground pad electrode coupled to the power pack; an ECG electrode coupled to the power pack; an insulator packaging the power pack with one or more ofthe electrodes; one or more batteries positioned in the power pack, each battery including battery contacts; an ECG detection circuit configured to supply a control signal representative of heart activity, wherein the ECG detection circuit is coupled to the power pack; and a defibrillation circuit responsive to the control signal and configured to deliver a discharge to the treatment electrode, wherein the defibrillation circuit is coupled to the power pack.

42. The portable defibrillator device of claim 41 , comprising: a memory device to store a digitized ECG signals before and after application of a defibrillation shock, wherein the memory device is positioned in the power pack.

43. The portable defibrillator device of claim 42, wherein the memory device is one or more memory chips.

44. A portable defibrillator device, comprising: a housing including a power pack; a treatment electrode configured to deliver a defibrillation shock and measure ECG activity of a patient, wherein the treatment electrode is coupled to the power pack; a ground pad electrode coupled to the power pack; one or more batteries positioned in the power pack, each battery including battery contacts; an ECG detection circuit configured to provide a control signal representative of heart activity; a defibrillation circuit responsive to the control signal and configured to deliver a discharge to the treatment electrode; and an memory device configured to store a digitized ECG signals before and after application of a defibrillation shock, wherein the memory device is positioned in the power pack.

45. A portable defibrillator device, comprising: a housing including a power pack; a treatment electrode configured to deliver a defibrillation shock and measure ECG activity of a patient, wherein the treatment electrode is coupled to the power pack; a ground pad electrode coupled to the power pack; an insulator packaging the power pack with one or more ofthe electrodes; one or more batteries positioned in the power pack, each battery including battery contacts; an ECG detection circuit configured to supply a control signal representative of heart activity, wherein the ECG detection circuit is coupled to the power pack; and a defibrillation circuit responsive to the control signal and configured to deliver a discharge to the treatment electrode, wherein the defibrillation circuit is coupled to the power pack.