WO2002056959A2 - An apparatus and a method for defibrillating and/or pacing a heart and an electrode means for use in the apparatus - Google Patents

An apparatus and a method for defibrillating and/or pacing a heart and an electrode means for use in the apparatus Download PDF

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Publication number
WO2002056959A2
WO2002056959A2 PCT/DK2002/000027 DK0200027W WO02056959A2 WO 2002056959 A2 WO2002056959 A2 WO 2002056959A2 DK 0200027 W DK0200027 W DK 0200027W WO 02056959 A2 WO02056959 A2 WO 02056959A2
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WO
WIPO (PCT)
Prior art keywords
providing
electrode
information
surface parts
electrically conducting
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Application number
PCT/DK2002/000027
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French (fr)
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WO2002056959A8 (en
WO2002056959A3 (en
Inventor
Regin Kopp Pedersen
Martin Dahl
Original Assignee
Cardiac Science Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
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Publication date
Application filed by Cardiac Science Inc. filed Critical Cardiac Science Inc.
Priority to AU2002219026A priority Critical patent/AU2002219026A1/en
Publication of WO2002056959A2 publication Critical patent/WO2002056959A2/en
Publication of WO2002056959A3 publication Critical patent/WO2002056959A3/en
Publication of WO2002056959A8 publication Critical patent/WO2002056959A8/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/38—Applying electric currents by contact electrodes alternating or intermittent currents for producing shock effects
    • A61N1/39—Heart defibrillators
    • A61N1/3925—Monitoring; Protecting

Definitions

  • the present invention relates to an apparatus and a method for defibrillating and/or pacing a heart of a person or an animal as well as an electrode means for use in the apparatus.
  • the invention relates to an electrode means having a plurality of separated electrically conductive surface parts where one is normally used in a defibrillation/pacing but which in a preferred embodiment may be used as different electrodes in an ECG measurement. These surface parts are short-circuited before defibrillation/pacing in order for the apparatus to be able to self-test and thereby evaluate the quality of the electrode means and the electrical interconnection thereto.
  • Electrode means or pads having a plurality of different electrically conducting surface parts may be seen in e.g. US-A-5,462,157, 5,080,099, 4,955,381, and 5,184,620.
  • a first aspect of the present invent relates to an apparatus for defibrillating/pacing the heart of a person or animal, the apparatus comprising:
  • At least two electrode means for providing the defibrillating/pacing current to the person or animal
  • first of the electrode means comprising at least one electrically conducting surface part at a surface part of the first electrode means
  • a second of the electrode means comprising at least two electrically conducting surface parts being spatially and electrically separated at a surface part of the second electrode means
  • the apparatus further comprising: removable means for providing an electrical connection between the at least two electrically conducting surface parts of the second electrode means, and means for, when the removable means provide the electrical connection, establishing an electrical circuit comprising the at least two electrically conducting surface parts of the second electrode means, the removable means, and the second means for providing electrical contact and providing information relating to that circuit.
  • the at least two electrode means are electrode means individually positionable around the heart.
  • the apparatus and the electrode means may be used externally on the person or animal or internally, such as in direct contact with the heart.
  • the current providing means should be adapted to the intended use of the apparatus.
  • the electrically conducting surface parts may be surface parts of different electrically conducting materials.
  • the removable means may be fully removable or displaceable so that contact may be provided between the person/animal and the electrically conductive surface parts.
  • This removable means may be attached or fixed to the electrode means by an adhesive, resilient fixing means or in any other manner.
  • a preferred manner is one wherein the foil is simply maintained in place by the adherence of the electrode, which is preferably a hydrogel electrode.
  • the removable means at least substantially cover the electrically conducting surface parts of the second electrode means.
  • At least part of at least one of the electrically conductive surface parts is a surface part of a hydrogel electrically connected to the first or second contact providing means.
  • Hydrogels have advantages in the use in external defibrillation/pacing.
  • the electrically conducting surface part(s) may be surface parts of only the hydrogel. Especially when using hydrogels, full coverage of the gel is desired in order to prevent it from drying out.
  • a preferred type of removable means comprises a folio or layer of an electrically conductive material, such as aluminium.
  • the apparatus further comprises means for measuring an ECG of the person or animal, wherein:
  • At least one of the electrically conducting surface parts of the first electrode means is electrically connected, via the first contact providing means, to the ECG measuring means, and at least two of the electrically conducting surface parts of the second electrode means are electrically connected, via the second contact providing means, to the ECG measuring means, one of the electrically conducting surface parts of the second electrode means being used as a guard electrode by the ECG measuring means.
  • At least one of the at least one electrically conducting surface parts of the first electrode means and connected to the ECG measuring means is electrically connected, via the first contact providing means, to the current providing means
  • at least one of the at least two electrically conducting surface parts of the second electrode means and connected to the ECG measuring means is electrically connected, via the second contact providing means, to the current providing means.
  • the same electrically conducting surfaces and the same electrically conducting means may be used both in the defibrillation and/or pacing and in the measuring of the ECG.
  • the apparatus may further comprise means for selectively providing and preventing electrical contact between the ECG measuring means and the electrically surface parts.
  • the means for selectively providing and preventing electrical contact may then be provided in order to protect the ECG measuring means when defibrillating/pacing.
  • these means may be brought to prevent the electrical contact when defibrillating/pacing and to provide the contact while providing the ECG.
  • means may be provided for selectively providing and preventing electrical contact between the electrical surface parts and the current providing means if the current providing means are not able to withstand the operation of the ECG measuring means or if the current providing means may interfere with the measuring of the ECG. It is desired that the information providing means comprise means for providing information relating to a resistance of the electrical circuit.
  • This quality may relate to the applicability of e.g. hydrogel electrodes the ohmic resistance of which increases when the electrodes dry out and thereby become useless.
  • the information providing means may be adapted to provide the information at regular time intervals. These time intervals may be from a few minutes to days, weeks, or months.
  • the information providing means comprise means for comparing the information provided with predetermined information and to inform an operator if the information provided does not fulfil predetermined criteria vis-a-vis the predetermined information, an operator may be asked to replace or repair a defect or low-quality apparatus before it is actually attempted used.
  • the use of a defect or low-quality apparatus may not provide the desired defibrillation/pacing result - or may actually endanger the operator or destroy the apparatus.
  • repairing the apparatus may comprise replacing low quality electrode means.
  • the information providing means are preferably adapted to provide numerical information relating to the electrical circuit, where the predetermined information is numerical information.
  • This numerical information may relate to e.g. the above resistance or any other measure determinable from the circuit.
  • This information might also relate to a voltage drop over the electrical circuit or a current transported there through - under predetermined conditions.
  • all of the electrode means of the apparatus may be of the type of the second electrode means.
  • the invention in a second aspect, relates to an electrode means for use in the above apparatus, the electrode means comprising at least two electrically conducting surface parts being spatially and electrically separated at a surface part of the electrode means and a removable means providing an electrical contact between the at least two electrically conducting surface parts.
  • the removable means preferably at least substantially covers the electrically conducting surface parts of the second electrode means.
  • At least part of at least one of the electrically conductive surface parts may be a surface part of a hydrogel electrically connected to the first or second contact providing means.
  • the electrically conducting surface part(s) is/are a surface part of the hydrogel.
  • the removable means preferably comprises a folio or layer of an electrically conductive material.
  • a third aspect of the invention relates to a method of defibrillating and/or pacing a heart of a person or animal using the above apparatus, the method comprising:
  • the step of operating the current providing means will only actually result in an operating thereof if the information provided fulfils predetermined criteria.
  • criteria may be that the information provided falls within predetermined limits vis-a-vis other information, such as predetermined information.
  • the apparatus further comprises means for measuring an ECG of the person or animal, wherein
  • the method preferably further comprises the step of, subsequently to the information- providing step and the step of removing the removable means, providing the ECG of the person or animal.
  • the ECG may be provided before and/or after the defibrillation/pacing. Obtaining the ECG before the defibrillation/pacing will ensure that a defibrillation/pacing is only performed if required. Performing the ECG after the defibrillation/pacing will provide information relating to the effect of the defibrillation/pacing.
  • At least one of the at least one electrically conducting surface parts of the first electrode means and connected to the ECG measuring means is electrically connected, via the first contact providing means, to the current providing means
  • - at least one of the at least two electrically conducting surface parts of the second electrode means and connected to the ECG measuring means is electrically connected, via the second contact providing means, to the current providing means
  • the apparatus further comprising means for selectively providing and preventing electrical contact between the ECG measuring means and the electrically conductive surface parts,
  • the step of providing the ECG preferably comprises preventing electrical contact during the providing of the ECG, such as in order to protect the ECG measuring means from the defibrillation/pacing current.
  • the step of providing the information comprises providing information relating to an electrical/ohmic resistance of the electrical circuit.
  • the step of providing the information may comprise providing the information at regular time intervals.
  • the step of providing the information comprises comparing the information provided with predetermined information and of informing an operator if the information provided does not fulfil predetermined criteria vis-a-vis the predetermined information.
  • a defect or poorly functioning apparatus may be replaced before being used in a defibrillation/pacing.
  • the step of providing the information may comprise providing numerical information relating to the electrical circuit, and where the step of comparing comprises comparing the provided information with predetermined, numerical information. Then, a numerical processor may be used for the comparison, self-check and evaluation.
  • Fig. 1 illustrates the electrode device and the apparatus according to the invention as a block diagram.
  • the apparatus 1 comprises a standard means 10 for providing a defibrillation/pacing current to the heart, preferably for external use, of a patient.
  • the current providing means 10 comprises two output leads 17 which are introduced into a selectable switching means 14 which will be described further below.
  • the current providing means 10 is a well-known product.
  • the apparatus further comprises an ECG measuring means 20 which is a standard product and which comprises three input leads 22: two leads 22', normally called the measuring electrodes, and the lead 22", a so-called guard electrode.
  • the leads 22' are also introduced into the switching means 14.
  • the apparatus further comprises two electrode devices 30 and 32, where the electrode device 32 is an electrode device according to the invention and comprises two electrodes 34 and 36 physically and electrically separated in the electrode device 32.
  • the electrode 30' of the electrode device 30 and the electrodes 34 and 36 are each individually connected to electrical conductors which, in connection providing means 40 and 42, respectively provide contact to the switching means 14 and the ECG measuring means 22 via the lead 22".
  • the switching means 14 act to separately and selectively connect either the leads 17 or the leads 22' to those leads of the connecting means 40 and 42 leading to the electrodes 30' and 34. In this manner, the leads 22' are not electrically connected to neither the leads 17 nor the electrodes 30' and 34 when the defibrillation/pacing current is provided by the means 10 via the connectors 17, switching means 14, the means 40, and the electrodes 30' and 34 to the patient.
  • the switching means 14 act to either provide a defibrillation/pacing current from the current providing means 10 and the electrodes 30' and 34 without exposing the ECG measuring means 20 to the defibrillation/pacing current and or to provide electrical signals from the electrodes 30' and 34 as well as the signals from electrode 36, when measuring an ECG of the person, without interference from the current providing means 10.
  • the ECG measuring means 20 may be provided so that it is able to withstand the voltage/current from the current generating means 10, whereby the switching means 14 is not required and the leads 17 and 22' may be directly connected to each other and to the corresponding leads of 40 and 42.
  • An ECG may be provided from the patient before and/or after providing a defibrillation/pacing pulse, in order to, before defibrillation/pacing, ensure that defibrillation/pacing is actually required and, after defibrillation/pacing, evaluate the effect of the defibrillation/pacing.
  • the apparatus 1 comprises an analysing means 50 which is connected to the leads in means 42 in order to, via an electrically conducting foil 52 (positioned so as to cover an area enclosed by the broken line) positioned, prior to the providing of the defibrillation/pacing pulses and/or the ECG, over the electrodes 34 and 36 in order to electrically interconnect these and in order to fully cover the surfaces thereof.
  • These electrodes 34 and 36 preferably are made of a hydrogel, which would otherwise rather quickly dehydrate and become useless.
  • the electrode means 30 and 32 are preferably additionally provided from the manufacturer in an airtight bag in order to better prevent such drying out.
  • the analysing means 50 is adapted to periodically or continuously determine the ohmic resistance between the leads in the means 42 to the electrodes 34 and 36 and via the removable cover 52.
  • This resistance will provide information both as to the electrical connections to the electrode means 32 but also information relation to the usefulness and the condition of the hydrogels of electrodes 34 and 36.
  • this analysis is performed once every day, week, fortnight or month in order for e.g. operator or supervising personnel to be made aware of malfunctioning or less than optimal functioning apparatus before this is used to defibrillate/pace and/or determine an ECG.
  • the electrode means 30 may be of the same type as that of 32, whereby e.g. two guard electrodes may be used for the ECG or the additional electrode (not illustrated) of electrode means 30 may be used in connection with another removable means in order to also provide the means 50 with information relating to the usefulness of the electrode means 30.
  • the results or conclusions of the measurement and thus the quality control of one electrode means (32) may be transferred from that electrode means to the other - normally if these are manufactured at at least approximately the same time.
  • the analysing means 50 operate by determining the ohmic resistance and comparing this resistance to predetermined limits and to also inform an operator or supervising personnel (such as by sound and/or light) if the ohmic resistance exceeds a given maximum value.

Abstract

An apparatus and a method for defibrillating and/or pacing the heart of a person or animal. Comprises means for establishing an electrical circuit comprising at least two electrically conducting surface parts of the electrode means, removable means, and second means for providing electrical contact between a surface part of an electrode and current providing means. The means for establishing an electrical circuit is adapted to provide information relating to that circuit. The apparatus may perform self-tests at regular time intervals based on information relating to an electrical/ohmic resistance of the electrical circuit. Thus, a defect/poorly functioning apparatus may be replaced before being used in a defibrillation/pacing, and the risk of encountering a defect apparatus is greatly reduced. Furthermore, electrode means for use in an apparatus according to the invention.

Description

AN APPARATUS AND A METHOD FOR DEFIBRILLATING AND/OR PACING A HEART AND AN ELECTRODE MEANS FOR USE IN THE APPARATUS
The present invention relates to an apparatus and a method for defibrillating and/or pacing a heart of a person or an animal as well as an electrode means for use in the apparatus.
More specifically, the invention relates to an electrode means having a plurality of separated electrically conductive surface parts where one is normally used in a defibrillation/pacing but which in a preferred embodiment may be used as different electrodes in an ECG measurement. These surface parts are short-circuited before defibrillation/pacing in order for the apparatus to be able to self-test and thereby evaluate the quality of the electrode means and the electrical interconnection thereto.
Electrode means or pads having a plurality of different electrically conducting surface parts may be seen in e.g. US-A-5,462,157, 5,080,099, 4,955,381, and 5,184,620.
A first aspect of the present invent relates to an apparatus for defibrillating/pacing the heart of a person or animal, the apparatus comprising:
- means for providing a defibrillating and/or pacing current,
at least two electrode means for providing the defibrillating/pacing current to the person or animal,
- a first of the electrode means comprising at least one electrically conducting surface part at a surface part of the first electrode means,
a second of the electrode means comprising at least two electrically conducting surface parts being spatially and electrically separated at a surface part of the second electrode means,
first means for providing electrical contact from at least one surface part(s) of the first electrode means to the current providing means,
- second means for providing electrical contact from at least one of the surface parts of the second electrode means to the current providing means,
the apparatus further comprising: removable means for providing an electrical connection between the at least two electrically conducting surface parts of the second electrode means, and means for, when the removable means provide the electrical connection, establishing an electrical circuit comprising the at least two electrically conducting surface parts of the second electrode means, the removable means, and the second means for providing electrical contact and providing information relating to that circuit.
In the present context, the at least two electrode means are electrode means individually positionable around the heart. In this context, the apparatus and the electrode means may be used externally on the person or animal or internally, such as in direct contact with the heart. Naturally, the current providing means should be adapted to the intended use of the apparatus.
Also, the electrically conducting surface parts may be surface parts of different electrically conducting materials.
In the present context, the removable means may be fully removable or displaceable so that contact may be provided between the person/animal and the electrically conductive surface parts. This removable means may be attached or fixed to the electrode means by an adhesive, resilient fixing means or in any other manner. A preferred manner is one wherein the foil is simply maintained in place by the adherence of the electrode, which is preferably a hydrogel electrode.
Preferably, the removable means at least substantially cover the electrically conducting surface parts of the second electrode means.
Also, preferably, at least part of at least one of the electrically conductive surface parts is a surface part of a hydrogel electrically connected to the first or second contact providing means. Hydrogels have advantages in the use in external defibrillation/pacing. Naturally, the electrically conducting surface part(s) may be surface parts of only the hydrogel. Especially when using hydrogels, full coverage of the gel is desired in order to prevent it from drying out.
A preferred type of removable means comprises a folio or layer of an electrically conductive material, such as aluminium.
In one embodiment, at least one of the electrically conducting surface parts of each of the first and second electrode means are electrically connected, via the first and second contact providing means, respectively, to the current providing means. Preferably, the apparatus further comprises means for measuring an ECG of the person or animal, wherein:
- at least one of the electrically conducting surface parts of the first electrode means is electrically connected, via the first contact providing means, to the ECG measuring means, and at least two of the electrically conducting surface parts of the second electrode means are electrically connected, via the second contact providing means, to the ECG measuring means, one of the electrically conducting surface parts of the second electrode means being used as a guard electrode by the ECG measuring means.
It is often desired to include means for measuring an ECG of the person/animal in order to be able to better evaluate the condition of the heart and to only defibrillate/pace if required.
Preferably: at least one of the at least one electrically conducting surface parts of the first electrode means and connected to the ECG measuring means is electrically connected, via the first contact providing means, to the current providing means, at least one of the at least two electrically conducting surface parts of the second electrode means and connected to the ECG measuring means is electrically connected, via the second contact providing means, to the current providing means.
Thus, the same electrically conducting surfaces and the same electrically conducting means may be used both in the defibrillation and/or pacing and in the measuring of the ECG.
The apparatus may further comprise means for selectively providing and preventing electrical contact between the ECG measuring means and the electrically surface parts. The means for selectively providing and preventing electrical contact may then be provided in order to protect the ECG measuring means when defibrillating/pacing. Thus, these means may be brought to prevent the electrical contact when defibrillating/pacing and to provide the contact while providing the ECG.
Also, means may be provided for selectively providing and preventing electrical contact between the electrical surface parts and the current providing means if the current providing means are not able to withstand the operation of the ECG measuring means or if the current providing means may interfere with the measuring of the ECG. It is desired that the information providing means comprise means for providing information relating to a resistance of the electrical circuit.
In this manner, a measure of the quality of e.g. the electrically conductive surface parts (or of the means for providing electrical contact) may be obtained. Thus, defibrillation/pacing may be prevented if a reduced quality or an immediate danger is foreseen.
This quality may relate to the applicability of e.g. hydrogel electrodes the ohmic resistance of which increases when the electrodes dry out and thereby become useless.
In order to obtain a self-test at regular time intervals, the information providing means may be adapted to provide the information at regular time intervals. These time intervals may be from a few minutes to days, weeks, or months.
When the information providing means comprise means for comparing the information provided with predetermined information and to inform an operator if the information provided does not fulfil predetermined criteria vis-a-vis the predetermined information, an operator may be asked to replace or repair a defect or low-quality apparatus before it is actually attempted used. The use of a defect or low-quality apparatus may not provide the desired defibrillation/pacing result - or may actually endanger the operator or destroy the apparatus. In this context, repairing the apparatus may comprise replacing low quality electrode means.
In order to have a numerical processor perform the comparison, the information providing means are preferably adapted to provide numerical information relating to the electrical circuit, where the predetermined information is numerical information. This numerical information may relate to e.g. the above resistance or any other measure determinable from the circuit. This information might also relate to a voltage drop over the electrical circuit or a current transported there through - under predetermined conditions.
Naturally, all of the electrode means of the apparatus may be of the type of the second electrode means.
In a second aspect, the invention relates to an electrode means for use in the above apparatus, the electrode means comprising at least two electrically conducting surface parts being spatially and electrically separated at a surface part of the electrode means and a removable means providing an electrical contact between the at least two electrically conducting surface parts.
As described, the removable means preferably at least substantially covers the electrically conducting surface parts of the second electrode means.
Also, at least part of at least one of the electrically conductive surface parts may be a surface part of a hydrogel electrically connected to the first or second contact providing means. Preferably, the electrically conducting surface part(s) is/are a surface part of the hydrogel.
The removable means preferably comprises a folio or layer of an electrically conductive material.
A third aspect of the invention relates to a method of defibrillating and/or pacing a heart of a person or animal using the above apparatus, the method comprising:
providing information relating to the electrical circuit, subsequently removing the removable means from the second electrode means and providing electrical contact between the person or animal and the electrically conducting surface parts of the first and second electrode means, depending on the information provided, operating the current providing means so as to provide a defibrillation/pacing current to the person or animal.
Thus, the step of operating the current providing means will only actually result in an operating thereof if the information provided fulfils predetermined criteria. Such criteria may be that the information provided falls within predetermined limits vis-a-vis other information, such as predetermined information.
When the apparatus further comprises means for measuring an ECG of the person or animal, wherein
at least one of the electrically conducting surface parts of the first electrode means is electrically connected, via the first contact providing means, to the ECG measuring means, and at least two of the electrically conducting surface parts of the second electrode means are electrically connected, via the second contact providing means, to the ECG measuring means, one of the electrically conducting surface parts of the second electrode means being used as a guard electrode by the ECG measuring means the method preferably further comprises the step of, subsequently to the information- providing step and the step of removing the removable means, providing the ECG of the person or animal.
Thus, the ECG may be provided before and/or after the defibrillation/pacing. Obtaining the ECG before the defibrillation/pacing will ensure that a defibrillation/pacing is only performed if required. Performing the ECG after the defibrillation/pacing will provide information relating to the effect of the defibrillation/pacing.
When: at least one of the at least one electrically conducting surface parts of the first electrode means and connected to the ECG measuring means is electrically connected, via the first contact providing means, to the current providing means, - at least one of the at least two electrically conducting surface parts of the second electrode means and connected to the ECG measuring means is electrically connected, via the second contact providing means, to the current providing means,
the apparatus further comprising means for selectively providing and preventing electrical contact between the ECG measuring means and the electrically conductive surface parts,
the step of providing the ECG preferably comprises preventing electrical contact during the providing of the ECG, such as in order to protect the ECG measuring means from the defibrillation/pacing current.
Preferably, the step of providing the information comprises providing information relating to an electrical/ohmic resistance of the electrical circuit.
Also, the step of providing the information may comprise providing the information at regular time intervals.
Desirably, the step of providing the information comprises comparing the information provided with predetermined information and of informing an operator if the information provided does not fulfil predetermined criteria vis-a-vis the predetermined information. In this manner, a defect or poorly functioning apparatus may be replaced before being used in a defibrillation/pacing.
In this situation, the step of providing the information may comprise providing numerical information relating to the electrical circuit, and where the step of comparing comprises comparing the provided information with predetermined, numerical information. Then, a numerical processor may be used for the comparison, self-check and evaluation.
In the following, the invention will be described with reference to the enclosed Fig. 1, which illustrates the electrode device and the apparatus according to the invention as a block diagram.
In Fig. 1, the apparatus 1 comprises a standard means 10 for providing a defibrillation/pacing current to the heart, preferably for external use, of a patient. The current providing means 10 comprises two output leads 17 which are introduced into a selectable switching means 14 which will be described further below. The current providing means 10 is a well-known product.
The apparatus further comprises an ECG measuring means 20 which is a standard product and which comprises three input leads 22: two leads 22', normally called the measuring electrodes, and the lead 22", a so-called guard electrode. The leads 22' are also introduced into the switching means 14.
The apparatus further comprises two electrode devices 30 and 32, where the electrode device 32 is an electrode device according to the invention and comprises two electrodes 34 and 36 physically and electrically separated in the electrode device 32. The electrode 30' of the electrode device 30 and the electrodes 34 and 36 are each individually connected to electrical conductors which, in connection providing means 40 and 42, respectively provide contact to the switching means 14 and the ECG measuring means 22 via the lead 22".
In the present embodiment, the switching means 14 act to separately and selectively connect either the leads 17 or the leads 22' to those leads of the connecting means 40 and 42 leading to the electrodes 30' and 34. In this manner, the leads 22' are not electrically connected to neither the leads 17 nor the electrodes 30' and 34 when the defibrillation/pacing current is provided by the means 10 via the connectors 17, switching means 14, the means 40, and the electrodes 30' and 34 to the patient.
Conversely, when the leads 22' are, via the switching means 14, connected to the electrodes 30' and 34, it is preferred that no electrical connection is made from the leads 22' to the leads 17 and thereby to the current providing means 10.
Consequently, the switching means 14 act to either provide a defibrillation/pacing current from the current providing means 10 and the electrodes 30' and 34 without exposing the ECG measuring means 20 to the defibrillation/pacing current and or to provide electrical signals from the electrodes 30' and 34 as well as the signals from electrode 36, when measuring an ECG of the person, without interference from the current providing means 10.
Alternatively, the ECG measuring means 20 may be provided so that it is able to withstand the voltage/current from the current generating means 10, whereby the switching means 14 is not required and the leads 17 and 22' may be directly connected to each other and to the corresponding leads of 40 and 42.
An ECG may be provided from the patient before and/or after providing a defibrillation/pacing pulse, in order to, before defibrillation/pacing, ensure that defibrillation/pacing is actually required and, after defibrillation/pacing, evaluate the effect of the defibrillation/pacing.
Finally, the apparatus 1 comprises an analysing means 50 which is connected to the leads in means 42 in order to, via an electrically conducting foil 52 (positioned so as to cover an area enclosed by the broken line) positioned, prior to the providing of the defibrillation/pacing pulses and/or the ECG, over the electrodes 34 and 36 in order to electrically interconnect these and in order to fully cover the surfaces thereof. These electrodes 34 and 36 preferably are made of a hydrogel, which would otherwise rather quickly dehydrate and become useless. In fact, the electrode means 30 and 32 are preferably additionally provided from the manufacturer in an airtight bag in order to better prevent such drying out.
The actual manner of manufacturing the electrode means 30 and 32 and the manner of electrically contacting the hydrogel may be seen in US-A-5,080,099.
The analysing means 50 is adapted to periodically or continuously determine the ohmic resistance between the leads in the means 42 to the electrodes 34 and 36 and via the removable cover 52.
This resistance will provide information both as to the electrical connections to the electrode means 32 but also information relation to the usefulness and the condition of the hydrogels of electrodes 34 and 36. Preferably, this analysis is performed once every day, week, fortnight or month in order for e.g. operator or supervising personnel to be made aware of malfunctioning or less than optimal functioning apparatus before this is used to defibrillate/pace and/or determine an ECG. Naturally, the electrode means 30 may be of the same type as that of 32, whereby e.g. two guard electrodes may be used for the ECG or the additional electrode (not illustrated) of electrode means 30 may be used in connection with another removable means in order to also provide the means 50 with information relating to the usefulness of the electrode means 30.
Alternatively, the results or conclusions of the measurement and thus the quality control of one electrode means (32) may be transferred from that electrode means to the other - normally if these are manufactured at at least approximately the same time.
Presently, the analysing means 50 operate by determining the ohmic resistance and comparing this resistance to predetermined limits and to also inform an operator or supervising personnel (such as by sound and/or light) if the ohmic resistance exceeds a given maximum value.

Claims

1. An apparatus for defibrillating and/or pacing the heart of a person or animal, the apparatus comprising:
means for providing a defibrillating/pacing current,
at least two electrode means for providing the defibrillating/pacing current to the person or animal,
a first of the electrode means comprising at least one electrically conducting surface part at a surface part of the first electrode means,
a second of the electrode means comprising at least two electrically conducting surface parts being spatially and electrically separated at a surface part of the second electrode means,
first means for providing electrical contact from at least one surface part(s) of the first electrode means to the current providing means,
second means for providing electrical contact from at least one of the surface parts of the second electrode means to the current providing means
the apparatus further comprising: - removable means for providing an electrical connection between the at least two electrically conducting surface parts of the second electrode means, and means for, when the removable means provide the electrical connection, establishing an electrical circuit comprising the at least two electrically conducting surface parts of the second electrode means, the removable means, and the second means for providing electrical contact and providing information relating to that circuit.
2. An apparatus according to claim 1, wherein the removable means at least substantially cover the electrically conducting surface parts of the second electrode means.
3. An apparatus according to claim 1 or 2, wherein at least part of at least one of the electrically conductive surface parts is a surface part of a hydrogel electrically connected to the first or second contact providing means.
4. An apparatus according to claim 3, wherein the electrically conducting surface part(s) is/are a surface part of the hydrogel.
5. An apparatus according to any of the preceding claims, wherein the removable means 5 comprises a folio or layer of an electrically conductive material.
6. An apparatus according to any of the preceding claims, wherein at least one of the electrically conducting surface parts of each of the first and second electrode means are electrically connected, via the first and second contact providing means, respectively, to
10 the current providing means.
7. An apparatus according to any of the preceding claims, the apparatus further comprising means for measuring an ECG of the person or animal, wherein
15 - at least one of the electrically conducting surface parts of the first electrode means is electrically connected, via the first contact providing means, to the ECG measuring means, and at least two of the electrically conducting surface parts of the second electrode means are electrically connected, via the second contact providing means, to the ECG 20 measuring means, one of the electrically conducting surface parts of the second electrode means being used as a guard electrode by the ECG measuring means.
8. An apparatus according to claim 7, wherein at least one of the at least one electrically conducting surface parts of the first 25 electrode means and connected to the ECG measuring means is electrically connected, via the first contact providing means, to the current providing means, at least one of the at least two electrically conducting surface parts of the second electrode means and connected to the ECG measuring means is electrically connected, via the second contact providing means, to the current providing means. 30
9. An apparatus according to claim 8, the apparatus further comprising means for selectively providing and preventing electrical contact between the ECG measuring means and the electrically conductive surface parts.
35 10. An apparatus according to any of the preceding claims, wherein the information providing means comprise means for providing information relating to a resistance of the electrical circuit.
11. An apparatus according to any of the preceding claims, wherein the information providing means are adapted to provide the information at regular time intervals.
12. An apparatus according to any of the preceding claims, wherein the information 5 providing means comprise means for comparing the information provided with predetermined information and to inform an operator if the information provided does not fulfil predetermined criteria vis-a-vis the predetermined information.
13. An apparatus according to claim 12, wherein the information providing means are 10 adapted to provide numerical information relating to the electrical circuit, where the predetermined information is numerical information.
14. An electrode means for use in the apparatus according to any of the preceding claims, the electrode means comprising at least two electrically conducting surface parts being
15 spatially and electrically separated at a surface part of the electrode means and a removable means providing an electrical contact between the at least two electrically conducting surface parts.
15. An electrode means according to claim 14, wherein the removable means at least 20 substantially covers the electrically conducting surface parts of the second electrode means.
16. An electrode means according to claim 14 or 15, wherein at least part of at least one of the electrically conductive surface parts is a surface part of a hydrogel electrically
25 connected to the first or second contact providing means.
17. An electrode means according to claim 16, wherein the electrically conducting surface part(s) is/are a surface part of the hydrogel.
30 18. An electrode means according to any of claims 14-17, wherein the removable means comprises a folio or layer of an electrically conductive material.
19. A method of defibrillating and/or pacing a heart of a person or animal using the apparatus according to any of claims 1-13, the method comprising :
35 providing information relating to the electrical circuit, subsequently removing the removable means from the second electrode means and providing electrical contact between the person or animal and the electrically conducting surface parts of the first and second electrode means, depending on the information provided, operating the current providing means so as to provide a defibrillation/pacing current to the person or animal.
20. A method according to claim 19, wherein the apparatus further comprises means for measuring an ECG of the person or animal, wherein
at least one of the electrically conducting surface parts of the first electrode means is electrically connected, via the first contact providing means, to the ECG measuring means, and - at least two of the electrically conducting surface parts of the second electrode means are electrically connected, via the second contact providing means, to the ECG measuring means, one of the electrically conducting surface parts of the second electrode means being used as a guard electrode by the ECG measuring means
the method further comprising the step of, subsequently to the information-providing step and the step of removing the removable means, providing the ECG of the person or animal.
21. A method according to claim 20, wherein - at least one of the at least one electrically conducting surface parts of the first electrode means and connected to the ECG measuring means is electrically connected, via the first contact providing means, to the current providing means, at least one of the at least two electrically conducting surface parts of the second electrode means and connected to the ECG measuring means is electrically connected, via the second contact providing means, to the current providing means,
the apparatus further comprising means for selectively providing and preventing electrical contact between the ECG measuring means and the electrically conductive surface parts,
wherein the step of providing the ECG comprises preventing electrical contact during the providing of the ECG.
22. A method according to any of claims 19-21, wherein the step of providing the information comprises providing information relating to an electrical/ohmic resistance of the electrical circuit.
23. A method according to any of claims 19-22, wherein the step of providing the information comprises providing the information at regular time intervals.
24. A method according to any of claims 19-23, wherein the step of providing the information comprises comparing the information provided with predetermined information and of informing an operator if the information provided does not fulfil predetermined criteria vis-a-vis the predetermined information.
25. A method according to claim 24, wherein the step of providing the information comprises providing numerical information relating to the electrical circuit, and where the step of comparing comprises comparing the provided information with predetermined, numerical information.
PCT/DK2002/000027 2001-01-19 2002-01-16 An apparatus and a method for defibrillating and/or pacing a heart and an electrode means for use in the apparatus WO2002056959A2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU2002219026A AU2002219026A1 (en) 2001-01-19 2002-01-16 An apparatus and a method for defibrillating and/or pacing a heart and an electrode means for use in the apparatus

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US26241601P 2001-01-19 2001-01-19
US60/262,416 2001-01-19

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4834103A (en) * 1980-08-08 1989-05-30 Darox Corporation Disposable physiological electrode set
US5356428A (en) * 1992-03-31 1994-10-18 Cardiotronics, Inc. Non-invasive, radiolucent electrode
US6148233A (en) * 1997-03-07 2000-11-14 Cardiac Science, Inc. Defibrillation system having segmented electrodes

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4834103A (en) * 1980-08-08 1989-05-30 Darox Corporation Disposable physiological electrode set
US5356428A (en) * 1992-03-31 1994-10-18 Cardiotronics, Inc. Non-invasive, radiolucent electrode
US6148233A (en) * 1997-03-07 2000-11-14 Cardiac Science, Inc. Defibrillation system having segmented electrodes

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WO2002056959A3 (en) 2002-11-21
AU2002219026A1 (en) 2002-07-30

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