CA2133424A1 - Sensor and system for physiological monitoring - Google Patents
Sensor and system for physiological monitoringInfo
- Publication number
- CA2133424A1 CA2133424A1 CA002133424A CA2133424A CA2133424A1 CA 2133424 A1 CA2133424 A1 CA 2133424A1 CA 002133424 A CA002133424 A CA 002133424A CA 2133424 A CA2133424 A CA 2133424A CA 2133424 A1 CA2133424 A1 CA 2133424A1
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- Prior art keywords
- patient
- ecg
- data
- complex
- sensor patch
- Prior art date
- Legal status (The legal status 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 status listed.)
- Abandoned
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/0002—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
- A61B5/0004—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network characterised by the type of physiological signal transmitted
- A61B5/0006—ECG or EEG signals
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
- A61B5/25—Bioelectric electrodes therefor
- A61B5/279—Bioelectric electrodes therefor specially adapted for particular uses
- A61B5/28—Bioelectric electrodes therefor specially adapted for particular uses for electrocardiography [ECG]
- A61B5/282—Holders for multiple electrodes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
- A61B5/316—Modalities, i.e. specific diagnostic methods
- A61B5/318—Heart-related electrical modalities, e.g. electrocardiography [ECG]
- A61B5/346—Analysis of electrocardiograms
- A61B5/349—Detecting specific parameters of the electrocardiograph cycle
- A61B5/35—Detecting specific parameters of the electrocardiograph cycle by template matching
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B2560/00—Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
- A61B2560/04—Constructional details of apparatus
- A61B2560/0406—Constructional details of apparatus specially shaped apparatus housings
- A61B2560/0412—Low-profile patch shaped housings
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
- Y02A90/00—Technologies having an indirect contribution to adaptation to climate change
- Y02A90/10—Information and communication technologies [ICT] supporting adaptation to climate change, e.g. for weather forecasting or climate simulation
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10S128/00—Surgery
- Y10S128/903—Radio telemetry
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Engineering & Computer Science (AREA)
- Cardiology (AREA)
- Molecular Biology (AREA)
- Surgery (AREA)
- Biophysics (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Medical Informatics (AREA)
- Physics & Mathematics (AREA)
- Pathology (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Physiology (AREA)
- Computer Networks & Wireless Communication (AREA)
- Measuring And Recording Apparatus For Diagnosis (AREA)
- Measurement And Recording Of Electrical Phenomena And Electrical Characteristics Of The Living Body (AREA)
Abstract
A patient (1) is provided with a sensor patch (2) which is worn on the skin of the chest of the patient. The sensor patch (2) includes a central structural support member (8) formed of a flexible, but rigid, plastics material. The structural member (8) is surrounded by an adhesive gel (9) which is preferably a hydrogel compound. The patch (2) is provided with a number of electrodes (10), for example four, which are positioned on the gel (9) so as to contact the skin of the patient (1) when the gel (9) adheres to the skin. The electrodes (10) are either metallic, such as stainless steel, or formed of a silver chloride compound and are electrically connected by connections (11) to an electronic package (12), which includes a power supply, circuitry for receiving ECG
signals from the electrodes (10), for conditioning the signals to provide a conditioned signal and a short range radio transmitter to transmit the conditioned signal to the portable monitor unit (3) which is nearby. The portable monitor unit (3) includes circuitry for interfacing with a telephone line (4) to send the ECG data signals to a central monitoring station (5) by the telephone line (4). The portable unit (3) preferably also has monitoring circuitry for monitoring the incoming ECG data signal to determine whether there is any abnormality and to alert the patient if an abnormality in the ECG data signal is detected. The central monitoring station (5) includes a part (6) that decodes the ECG data signals received from the portable unit (3) via the telephone line (4) and performs beat and rhythm analysis for classification of the ECG
data. Periodically, data is reviewed by a professional skilled in the field and a report generated (7).
signals from the electrodes (10), for conditioning the signals to provide a conditioned signal and a short range radio transmitter to transmit the conditioned signal to the portable monitor unit (3) which is nearby. The portable monitor unit (3) includes circuitry for interfacing with a telephone line (4) to send the ECG data signals to a central monitoring station (5) by the telephone line (4). The portable unit (3) preferably also has monitoring circuitry for monitoring the incoming ECG data signal to determine whether there is any abnormality and to alert the patient if an abnormality in the ECG data signal is detected. The central monitoring station (5) includes a part (6) that decodes the ECG data signals received from the portable unit (3) via the telephone line (4) and performs beat and rhythm analysis for classification of the ECG
data. Periodically, data is reviewed by a professional skilled in the field and a report generated (7).
Description
WO 93/19667 PCr/AlJ93~00143 SENSOR AND SYSTEM FOR PHY$IOLOGICAL MONITORING
BACKGRO~ND OF THE INVENTION
This invention relates to a sensor and system that is used to monitor and analyse electrocardiogram signals remotely from patients located in non-hospital sites.
As used herein, the term "electro-cardiogram" (ECG) refers to an electrical signal from the heart wh~,ch may be measured from two or more sensors placed on the patients skin, either on a limb or about the patient's thorax.
The term "complex" refers to a period o~ ECG signal which, when voltage amplitude is plotted against time, exhibits a shape which may be repeated in other epochs. Typically, a complex will include a particular amplitude maxima or minima which is termed the detect point. The rate at which detect points occur in a particular ECG
signal is the same as the heart rate. The term 'normal complex' re~ers to a complex in an ECG signal that is regularly repeated and is measured at electrodes placed on c~ person whose heart is beating in Normal Sinus Rhythm (NSR). The shape of a normal complex may vary from patient to patient and between ECG signal~ recorded from d1fferent sites on the same patient.
The terms P, Q, R, S and T when used herein in relation to ECG
complexes refer to portions o~ a normal complex that relate to particular electro-physiological events in the cardiac cycle.
The term "normal rate" for a particular patient refers to a range ~25 of heart rates that is typical ~or a healthy individual of~simi~ar age ~ to the patient when at rest.
; The term i'arrhythmia" relates to an abnormal rhythm of the heart that persists for multiple complexes which may or may not revert to normal sinus rhythm spontaneously. An arrhythmia may be made up of normal complexes at a rate that is abnormally high for the patient or abnormally low or, alternatively, an arrhythmia may consi~t of abnormal complexes at a high. low or~normal rate.
In known systems, the pati~ent i~ provided with ;ensors attached to the patient's body and which are coupled by electrical leads to an ~ 35 event recorder. The event recorder then sends the ECG signals to the ;~ monitoring system via a telecommunications line, e.g. a telephone line.
A major disadvantage of these known systems is that continuous monitoring of a patient has been met wi th a di sti nct 1 ack of enthusi asm ~ O ~ M4AY 19~4 ~13342~
by-the'patient due to the need for a lead to connect the sensors to the event recorder. This causes discomfort and difficulties in dressing and washing, and also some embarassment as it is difficult to hide from view.
BRIEF S~M~ARY OF THE INVENTIQN
It is an object of the present inventlon to provide a sensor and system whereby a patient can have their ECG monitored from home without requiring a visit by personne1 skilled in the acquisition or interpretation of the ECG and which is comfortable and easy to wear and use.
Accordingly, in one aspect, the invention provides a sensor patch for attachment"to a patient's body for obtaining physiological data from the patient and transmitting the physiologlcal data to monitoring equipment, the sensor patch comprising a structural support member, sensing means for sensing physiological data from the patient's body, adhesive means for attaching the sensor patch to the patient's body, an electronics package including a power supply and circuitry for processirg the sensed data to produce a conditioned signal, communication means for passing the sensed data from the sensing means to the electronics package, and a trans~itter for transmitting the conditioned signal fr~m the sensor patch to the monitoring equipment, wherein the electronics package and transmitter form part or parts of the sensor pa~ch itself.
Preferably, the sensing means comprises a plur~lity of electrodes for sensing changes in electr~cal potential of the patient's body. The electrodes can be metallic, e.g. stainless steel, or they could be made of a silver chlor~de compound. A conductive paste ~s preferably' provided as an interface betwen the electrodes and the skin of the patient.
Alternatively, or additionally, the sensing means could comprise one or more thermistors to sense the temperature of the patient's body.
The adhesive means preferably comprises a hydroge1 compound which is electrostatically active and rehydrates i~self. A preferred hydrogel compound contains salts~which migrate between the skin of the patient and the sensors, thus reducing skin irritation due to maintenance of pH by the salt migration. Electrical balance is rhk/ 606 E
AMEND~D SHE}~T
IPEA/AU
PCI`/AU 93 1 ~01 45 , -maintained since electrical conductivity is reduced as the moisture content of the hydrogel compound is reduced, which also reduces the pH.
The transmitter is preferably a radio transmitter, although microwave or infra-red transmitters could alternatively be used.
According to a second aspect of the inventlon, there is provlded an ECG monitoring system comprising a sensor patch as described above for sensing and transmitting data representing an ECG signal of a patient, means for receiving the sensed data from the sensor patch at a primary site ln the vicinity of the patient and for storing the sensed data, and means for sendlng the stored data from the primary site to a monitoring station where the ECG signal is monttored and analyzed.
In a preferred embodiment, the stored data is sent to the monitoring station at a central site v~a the standard voice telecommunications network.
IS Preferably, the central site is remote from the primary site and the monitoring station is preferably capable of receiving and monitoring data from a large number of primary sites. Preferably, the means for receiving the sensed data and the means for sending the stored data are within a portable unit, which can be easily carried around by the patient.
In a preferred embodiment, the portable unit also includes means for monitoring the received data to detect an abnormality in the sensed data, and means for alerting the patient that an abnormality has been detected.
The method of modulation and transmission of the ECG s~gnal over the voice telecommunicat~ons network is well known in the prior~art and :
does not form part of the~present~invention.
According to a~further~aspect~of the invent~on, there is provided a monitoring statlon for~mon~itoring and analysing ECG signals from a patient, the station comprising;reCeiving means for receiving raw ECG
data signals, first processing means coupled to the receiving means for processing the received raw~ECG data to provide a standardised digital ; signal representative of the~ECG~data, recognition means coup1ed to the first processing means for recognising and storing a current characteris~ic complex ln a card~ac cycle;of ~the EC~ data, storage means for storing a reference complex from the cardiac cycle of the rhkl606E
AMENDED SH~T
lPEA/AU
WO 93~19667 PCT/AIJ93/00143 213~24 4 same patient, comparing means coupled to the recognition means and the storage means for comparing the current characteristic complex stored in the recognition means with the reference complex stored in the storage means and producing a similarity index signal indicatlve of the degree of similarity between the current characteristic complex and the refer~nce complex, analysing means coupled to the comparing means for analysing a current characteristic complex which has been matched with the reference complex to determine whether cardiac arrhythmia is present in the ECG data, and alarm means coupled to the analys1ng means for ~enerating an alarm if the presence o~ a cardiac arrhythmia in the ECG data slgnals is detected.
In a preferred embodiment, the reference complex stored in the storage means is a normal complex. However, the storage means preferably stores, additionally or alternatively to the normal complex, lS one or more abnormal complexes of the cardiac cycle of the patient.
Preferably, the comparing means compares the current characteristic complex with each of the stored reference complexes. In one preferred embodiment, the comparing means first compares the current characterist1c complex with a normal reference complex stored in the storage means. If the similarity index signal indicates a lack of similarlty between the current characteristic complex and the normal reference complex, then the comparing means compares the current characteristic cQmplex with each abnormal reference complex, in turn, until the similarity index signal indicates a match. If the current characteristic complex does not match any of~the stored re~eren~e complexes, then it is considered by a skilled operator and either discarded or entered in the s~orage means as another abnormal reference complex.
Although the monitoring;station is usually used to mon~tor ECG
signals ~rom many patients at various sites remotely, the signals being sent to the monitortng station via a telecommunication system; it is equally applicable~where a patient and the monitoring station are at the same site.
In an embodiment where the patient and monitoring station are conveniently at the same site and the patient is undergoing treatment using an automatic treatment device, such as an automatic drug delivery device, the alarm means is preferably coupled to a controller of the automatic treatment device so as to appropriately control the automatic ~3~2~
treatment device according to whether a cardiac arrhythmia in the ECG
data signals is detected. The automatic treatment device can be an automatic drug delivery system, such as an infusion pump, or could be an external pacemaker dev~ce or a de-~ibrillation device.
S Furthermore, although the mon~toring station usually monitors only one ECG signal from a ~articular patient at a time, it can equally be used to monitor more than one ECG signal from one patient or ECG
signals from multiple patients simultaneously. The monitoring station can also be used in systems that are capable of mon~toring other physiologlcal signals (including, but not limited to: blood pressure, spirometry signals and contractility signals) in add~tion to the ECG
signal, as well as to systems which only monitor ECG signals.
Other advantages of the monitoring station according to the invention are:
1. It detects the presence of a dangerous cardiac state from the ECG
automatically at the time that the FCG is being monitored.
BACKGRO~ND OF THE INVENTION
This invention relates to a sensor and system that is used to monitor and analyse electrocardiogram signals remotely from patients located in non-hospital sites.
As used herein, the term "electro-cardiogram" (ECG) refers to an electrical signal from the heart wh~,ch may be measured from two or more sensors placed on the patients skin, either on a limb or about the patient's thorax.
The term "complex" refers to a period o~ ECG signal which, when voltage amplitude is plotted against time, exhibits a shape which may be repeated in other epochs. Typically, a complex will include a particular amplitude maxima or minima which is termed the detect point. The rate at which detect points occur in a particular ECG
signal is the same as the heart rate. The term 'normal complex' re~ers to a complex in an ECG signal that is regularly repeated and is measured at electrodes placed on c~ person whose heart is beating in Normal Sinus Rhythm (NSR). The shape of a normal complex may vary from patient to patient and between ECG signal~ recorded from d1fferent sites on the same patient.
The terms P, Q, R, S and T when used herein in relation to ECG
complexes refer to portions o~ a normal complex that relate to particular electro-physiological events in the cardiac cycle.
The term "normal rate" for a particular patient refers to a range ~25 of heart rates that is typical ~or a healthy individual of~simi~ar age ~ to the patient when at rest.
; The term i'arrhythmia" relates to an abnormal rhythm of the heart that persists for multiple complexes which may or may not revert to normal sinus rhythm spontaneously. An arrhythmia may be made up of normal complexes at a rate that is abnormally high for the patient or abnormally low or, alternatively, an arrhythmia may consi~t of abnormal complexes at a high. low or~normal rate.
In known systems, the pati~ent i~ provided with ;ensors attached to the patient's body and which are coupled by electrical leads to an ~ 35 event recorder. The event recorder then sends the ECG signals to the ;~ monitoring system via a telecommunications line, e.g. a telephone line.
A major disadvantage of these known systems is that continuous monitoring of a patient has been met wi th a di sti nct 1 ack of enthusi asm ~ O ~ M4AY 19~4 ~13342~
by-the'patient due to the need for a lead to connect the sensors to the event recorder. This causes discomfort and difficulties in dressing and washing, and also some embarassment as it is difficult to hide from view.
BRIEF S~M~ARY OF THE INVENTIQN
It is an object of the present inventlon to provide a sensor and system whereby a patient can have their ECG monitored from home without requiring a visit by personne1 skilled in the acquisition or interpretation of the ECG and which is comfortable and easy to wear and use.
Accordingly, in one aspect, the invention provides a sensor patch for attachment"to a patient's body for obtaining physiological data from the patient and transmitting the physiologlcal data to monitoring equipment, the sensor patch comprising a structural support member, sensing means for sensing physiological data from the patient's body, adhesive means for attaching the sensor patch to the patient's body, an electronics package including a power supply and circuitry for processirg the sensed data to produce a conditioned signal, communication means for passing the sensed data from the sensing means to the electronics package, and a trans~itter for transmitting the conditioned signal fr~m the sensor patch to the monitoring equipment, wherein the electronics package and transmitter form part or parts of the sensor pa~ch itself.
Preferably, the sensing means comprises a plur~lity of electrodes for sensing changes in electr~cal potential of the patient's body. The electrodes can be metallic, e.g. stainless steel, or they could be made of a silver chlor~de compound. A conductive paste ~s preferably' provided as an interface betwen the electrodes and the skin of the patient.
Alternatively, or additionally, the sensing means could comprise one or more thermistors to sense the temperature of the patient's body.
The adhesive means preferably comprises a hydroge1 compound which is electrostatically active and rehydrates i~self. A preferred hydrogel compound contains salts~which migrate between the skin of the patient and the sensors, thus reducing skin irritation due to maintenance of pH by the salt migration. Electrical balance is rhk/ 606 E
AMEND~D SHE}~T
IPEA/AU
PCI`/AU 93 1 ~01 45 , -maintained since electrical conductivity is reduced as the moisture content of the hydrogel compound is reduced, which also reduces the pH.
The transmitter is preferably a radio transmitter, although microwave or infra-red transmitters could alternatively be used.
According to a second aspect of the inventlon, there is provlded an ECG monitoring system comprising a sensor patch as described above for sensing and transmitting data representing an ECG signal of a patient, means for receiving the sensed data from the sensor patch at a primary site ln the vicinity of the patient and for storing the sensed data, and means for sendlng the stored data from the primary site to a monitoring station where the ECG signal is monttored and analyzed.
In a preferred embodiment, the stored data is sent to the monitoring station at a central site v~a the standard voice telecommunications network.
IS Preferably, the central site is remote from the primary site and the monitoring station is preferably capable of receiving and monitoring data from a large number of primary sites. Preferably, the means for receiving the sensed data and the means for sending the stored data are within a portable unit, which can be easily carried around by the patient.
In a preferred embodiment, the portable unit also includes means for monitoring the received data to detect an abnormality in the sensed data, and means for alerting the patient that an abnormality has been detected.
The method of modulation and transmission of the ECG s~gnal over the voice telecommunicat~ons network is well known in the prior~art and :
does not form part of the~present~invention.
According to a~further~aspect~of the invent~on, there is provided a monitoring statlon for~mon~itoring and analysing ECG signals from a patient, the station comprising;reCeiving means for receiving raw ECG
data signals, first processing means coupled to the receiving means for processing the received raw~ECG data to provide a standardised digital ; signal representative of the~ECG~data, recognition means coup1ed to the first processing means for recognising and storing a current characteris~ic complex ln a card~ac cycle;of ~the EC~ data, storage means for storing a reference complex from the cardiac cycle of the rhkl606E
AMENDED SH~T
lPEA/AU
WO 93~19667 PCT/AIJ93/00143 213~24 4 same patient, comparing means coupled to the recognition means and the storage means for comparing the current characteristic complex stored in the recognition means with the reference complex stored in the storage means and producing a similarity index signal indicatlve of the degree of similarity between the current characteristic complex and the refer~nce complex, analysing means coupled to the comparing means for analysing a current characteristic complex which has been matched with the reference complex to determine whether cardiac arrhythmia is present in the ECG data, and alarm means coupled to the analys1ng means for ~enerating an alarm if the presence o~ a cardiac arrhythmia in the ECG data slgnals is detected.
In a preferred embodiment, the reference complex stored in the storage means is a normal complex. However, the storage means preferably stores, additionally or alternatively to the normal complex, lS one or more abnormal complexes of the cardiac cycle of the patient.
Preferably, the comparing means compares the current characteristic complex with each of the stored reference complexes. In one preferred embodiment, the comparing means first compares the current characterist1c complex with a normal reference complex stored in the storage means. If the similarity index signal indicates a lack of similarlty between the current characteristic complex and the normal reference complex, then the comparing means compares the current characteristic cQmplex with each abnormal reference complex, in turn, until the similarity index signal indicates a match. If the current characteristic complex does not match any of~the stored re~eren~e complexes, then it is considered by a skilled operator and either discarded or entered in the s~orage means as another abnormal reference complex.
Although the monitoring;station is usually used to mon~tor ECG
signals ~rom many patients at various sites remotely, the signals being sent to the monitortng station via a telecommunication system; it is equally applicable~where a patient and the monitoring station are at the same site.
In an embodiment where the patient and monitoring station are conveniently at the same site and the patient is undergoing treatment using an automatic treatment device, such as an automatic drug delivery device, the alarm means is preferably coupled to a controller of the automatic treatment device so as to appropriately control the automatic ~3~2~
treatment device according to whether a cardiac arrhythmia in the ECG
data signals is detected. The automatic treatment device can be an automatic drug delivery system, such as an infusion pump, or could be an external pacemaker dev~ce or a de-~ibrillation device.
S Furthermore, although the mon~toring station usually monitors only one ECG signal from a ~articular patient at a time, it can equally be used to monitor more than one ECG signal from one patient or ECG
signals from multiple patients simultaneously. The monitoring station can also be used in systems that are capable of mon~toring other physiologlcal signals (including, but not limited to: blood pressure, spirometry signals and contractility signals) in add~tion to the ECG
signal, as well as to systems which only monitor ECG signals.
Other advantages of the monitoring station according to the invention are:
1. It detects the presence of a dangerous cardiac state from the ECG
automatically at the time that the FCG is being monitored.
2. It compares ECG signals recorded from a pdtient at different times in a way that allows an assessment as to whether the cardlac state of the patient has changed over time.
; 20 3. It provides an alarm ~f a new, pathological cardiac state develops in a patient so~that assessment from an.expert in the art of ECG interpretation may be obtained and/or medical intervention be initiated.
BRIEF DESCRIPTION OF THE DRAWINGS
Further features;and advantages of the present invent~ion become more fully apparent from the detailed description of one embodiment of the invention given~below, when read in conjunction with the accompanying~drawings) wherein~
Figure l is a schematic di~agram of a sensing and analysing system according to one embodiment of the invention;
Figure 2 is a schematic top plan view o~ a sensor patch used in the system o~ Figure~
Figure 3 is a schematic cross-sectional view through the sensor patch of Figure 2;
Figure 4 is a schemat~ic block diagr~am showing a monitoring station used in t~he system of Figure 1~;~
Figure 5 is a flow diagram showing the processing carried out in the monltoring staion of Figure 4;
.
WO 93/19667 PCr~AlJ93/00143 ~ 4 6 ~
Figure 6 is a flow diagram showing the flow of information which occurs when a patient is ~irst presented to the system; and Figure 7 is a schematic block diagram similar to that of Figure 4, showing the alarm system used to control a drug delivery system.
S DETAILED DES~RIPTION OF THE ILLUSTRATIVE EMBODIMENT
There is shown in Flgure 1, in block diagram form, a system for sensing and analysing ECG data sisnals from a patient to determine whether arrhythmia is present, and, i~ so, to produce an alarm. A
patient 1 is provided with a sensor patch 2, of a type to be further described below, which is worn on the skin of the chest. The sensor patch includes a radio transmitter, as well as a power supply, and transmits ECG data signals, conditioned, as necessary, by sultable conditioning circuitry in the se!lsor patch, to a portable monitor unit 3.
The portable monitor unit 3 is designed to be easily carried around by the patient, pre~erably in a pocket, and încludes a receiver for receiving the ECG data~signals transmitted from the sensor patch ;~ 2. The unit 3 also includes circuitry for interfacing with a telephone line 4 to send the ECG data sign~als to a central monitoring station 5 ; 20 by the telephone line 4. The portable unit 3 preferably also has monitoring circultry for monitoring the incoming ECG data slgnal to determine whether there ~is any abnormaiity and to alert the patient if an abnormality in the~ECG data signal is detected.
The central mon~itoring station 5 includes a part & that decodes the ECG data signal~s received from the portable unit 3 via-the-telephone line 4 and~performs beat and rhythm analysis for classification of~the ECG data.~ Periodically, data is reviewed by a ~` professional skilled~in;the fi~eld and a report generated (7~.
Turning now to~Figures 2 and 3, the sensor patch 2 will be further described. The patch 2 is approximately the size of a playing , ;~ card, for example 110 mm long bv 70 mm wide and is approximately lOmm thick. Thus, it~can~be easily worn by a patient without much discomfort. The~patch~comprises a central structur~l support member 8 formed of a~flexible, but r~igld, plastics material, such as Milar. The structural member 8 is surrounded by an adhesive gel 9 which is prefèrably a hydrogel~ compund. The hydrogel compund is a sticky jelly which contains salts~ such~as Sodium and Potassium. Provided the jelly is wet, the pH balance is maintained and the salts migrate between th~
W O 93/19667 ~ ~ ~ 3 ~ 2 4 Pcr/Aug3/oo143 skin of the patient and electrodes attached to the jelly and in contact with the skin. This migration of salts maintains the electrostatic balance and thereby reduces ~rritation. As the water content reduces, the pH and the electrical con~uctivity of the gel is reduced, thereby reducing the salt m~gration. By making sure that the patient wearing the patch has a bath or shower at least once a day, the gel becomes rehydrated and it is expected that such a patch will last and operate continuously for at least a week before its power supply is exhausted an~ it is thrown away.
The patch is provlded with a number of electrodes 10, for example four, which are positioned on the gel 9 so as to contact the skin of the patient when the gel 9 adheres to the skin. A conductive paste may be used between the electrodes and the skin of the patient to improve the electical conductivity therebetween. The electrodes 10 are either metallic, such as stainless steel, or formed of a silver chloride compound and are electrically connected by connections 11 to an ele`ctronic package 12.
The electronic package 12 lncludes a power supply, such as a small cell, circuitry for receiving signals from the electrodes 10, for conditioning the signals to provide a conditioned signal and a short range radio transmitter to transmit the conditioned signa1 to the portable monitor unit 3 which is nearby, and associated support ;~ clrcuitry. Thus, by hav~ng the radio transmitter at the same point as the sensors, the need for electrical signal lines fro~ the sensor to a monitoring unit is avoided. As previously mentioned, the trans~tter need not be radio,~ but could~be microwave~or lnfra-red, if ~n direct line of sight~w1th the receiver in the portable unit.
The eonditioning circuitry~processes the signals from each electrode by filtering the~signals and normalising according to mQasurements made when the respective electrode is disconnected. The normalised signals may also be compared to produce a difference signal representing the differen~ce~in;potential~ sensed by different electrodes. Alternatively, the~normalised signal from each electrode may be transmitted to the~portable unit 3, where such comparisons are undertaken.
~ hen the patient feels discomfort or concern, or if the portable unit gives an alarm, the patient telephones the central monitoring station and downloads the stored data from the portable unit via the W O 93/1s667 PCT/AU93/00143 c~ ~5~ 31~ 8 -standard telephone line. If re~uired, the patient can also transmitcurrent, real time ECG dat~aiso that the it can be evaluated by the centra~ station and any necessary actton can be taken.
Figure 4 illustrates the interconnection of the hardware used at the Central Monitoring Station analysls site.
The modulated ECG signal ~rom the telephone network is demodulated by demodulator 13. The signal is then digitized by an analogue to digital converter 14 at regular sampllng intervals. The digital representation of~the ECG signal is then input to a general purpose digltal computer 15.
he combined gain of the demodulator 13 and analog to digital converter 14 may be automatically adjusted by the demodulator 13, ~' analog to digital converter 14, the computer 15 or by any combination of these three. Connectlons~or automatic gain control between these elements are not shown in figure 4.
The computer 15 processes the ECG: data to decide if a dangerous cardiac event is occurring.~ The ECG data is also processed to extract information which may~be~stored~in such a way that will allow tracking of the state Qf the patient'~s~cardi~ac dis'ease over prolonged periods.
The~storage media'l~6 which can be optical, magnetic or any other type, is used to store the digital representation of the ECG data and information~derived~from it,~as~well às~patient~ident~fication data and clinical information.
When~ the analysi~s~performed'~by~:the computer l;5 indicate that a 25~ dangerous~even~t i's~occurring in~the ECG'currently bèing processed, an a1arm~is~raised~by~the~alarm~system~17. ~h~en an alarm is raised it is env1~saged that~the~stàff~present~at~the analysis site would initiate medical;~intervent~l~on;~to;~allevi;ate'~the~dangerous event.
; The proce~ssi~ng'~of~the ECG da~ta~takes place as shown in figure 5.
In the illustrativé embodiment of the invention, the sampled ECG signal 18 is~initi;ally processed~by;~filters to remove baseline wander and mains~frequency interference 1~9. The~fllters~used in step 19 remove unwanted~b~asellne~wand~er and~ma~lns~frequency~interference without causing~distortlon of~the~shape~of~th~e~underlyi~ng ECG complexes in the 35~ signal.~
The fil'tered signal~is~then proce~ssed at~step 20 to detect R wave points;in`~time in the~ECG~;sl:~gnal~ Portions of the~signal either side of each R~point together witn the R point ltself ~orm a template which : ` : : : : :
WO g3~19667 PCI/AU~3/00143 .~
` - 9~133~2~
is located in the signal by the template location step 21. This template is then processed in comparison step 22.
The compar~son step 22 compares the template in the current ECG
signal, referred to as the test template and produces a number termed a "similarity index". The test template is extracted from the template store 23. If the similarity index produced by the comparison of the current template with the test template is above a predetermined threshold, a match is found. If not, the two templates do not match.
The test template and current template are coherent in time in so far as the R point occurs at the same duration from the start of each template.
The templates which may be used as test templates in the template store are generated for a particular patient when the patient is first presented to the system. Generation of test templates is illustrated in Figure 6.
Referring now to Figure 6, when a patient is first presented to ; the system the patient~s raw ECG signal 30 is again processed (31) by , ~ , the baseline and interference filters. A~representative ECG template i5 automatically generat~ed~32~for~this patient and stored ln the template store 33.~ The representative~template will match most the ECG
complexes in the~patient's fi~rst ECG signal recorded by the system. I~
the patient exhibi~ts normal s1nus rhythm, the representative template wil~l represent a normal QRS~comple~x~w~ith morphological percullarities relevant to the particular~surface lead~u~sed to record the ECG. In a patient that does not~exhiblt normal~sinus~rhythm, the rep~esen~ative template will reflect the~morphological~abnormalities present in most of the patient's~ECG complex~es~
Templates~that~do not match~the representative template are then checked by an~expert in the~field;of~E~G ~i~nterpretation and artifacts are separated (34) from legitimate abnormal complexes. Abnormal complexes exhibit an abnormal~morphology for the patient ~such as, but not limi~ted to Ventricu~l~ar`Ec;topi~c Beats~rom vario~s foci) also can be store~ as template~s.~; The~se~abnormal~templates are then annotated (35) by~the expert with labels~that rçflect;the origin of the abnormal morphology~ The annotated,~abnormal complexes are then stored in the template store 36.
::
Once an initial ECG has~been recorded from a patient, subsequent EGG recordings do not generate~a~new repr~esentative template. The : ~ ;
WO 93/1g667 ~ PCI/AU93/OOt43 1 o - '"
recording of the initial ECG requires an operator skilled in the art of interpretation of ECG signals to ensure appropriate labelling of abnormal templates. Subseq~ènt recordings from a patient do not require the presence o~ an operator with such skills.
Returning now to Figure 5 illustrating the operation of the analysis system when a signal is received from a patient who has previously had an ECG recorded by the system, the comparison step 22 is initially used to compare in-coming complexes w~th the previously generated representative template. When a complex 1s found that does not match the represent~tive template, the comparison step 22 then compares the unknown complex with each abnormal template ~or the patient in turn. In this way, the number of beats that are considered normal for the patient as well as the number and type of ectopic or abnormal beats can be automatically generated at the time that the ECG
signal is being received.
If a complex is found that does not match the representative template nor any of the patient's abnormal templates, it is marked as unknown and at a later~ time can be discarded by the operator if it is considered to be an artifact or used to generate a new abnormal template for the patient. This can be done after the ECG containing the unknown template has been recorded by personnel with ECG
interpretation sk111s. ~ ~
After each complex has been categorized by the comparison algorithm, an arrhythmia detection step 24 determines 1f the patient is experiencing a cardiac arrhythmia. The arrhythmia det0ction step 24 determines the presence~;of~an arrhythmia from the underlying heart rate and the type of beat às determined by the comparison step 22.
If a cardi~ac arrhythmia is detected by the arrhythmia detection step 24, an alarm is ralsed (25) and medical intervention can be instigated by staff at the analysis centre.
.
A parameter measurement procedure 26 i, applied after the .
template comparison step 22. This procedure 26 detects fiducial point, in each complex~that matches the representative template and generates interval parameters relat~ing to the P, Q, R, S and T points in the complex. ~ ~
The ECG signàl is then annotated (27) with the results from the comparison step 22, the arrhythmia detection step 24 and the P, Q, R, S, T location proc~edure 26.
WO g3/19667 PCT/AU93/00143 . -21~! 3 3 ~1 2 4 The annotated ECG is then stored for later review of this analysis period in store 28.
Statistics, such as aver~ge, maximum, and minimum heart rate, numbers of different types of ectopic beats, types and durations of arrhythmic eplsodes and average complex parameter values are generated for the period of ECG analysed in step 29 and stored in store 37.
The stat~stical data and annotated ECG are recorded every time a patient transmits an ECG to the system. The stored information derived by the processing from the ECG's, ECG data itself as well as representative and abnormal templates can be reviewed at a later time.
This information will provide a comprehensive history of the patient's cardiac disease state.
Thus, comprehensive ambulatory surveillance of cardiac sick and high risk patients can be carried out, whilst provlding the patient with a greater degree of freedom than has been possible hitherto. It will, of course, be appreciated that, although only one particular embodiment of the invention has~been described in detail, various modificat~ons and improvements can be made to what has been described without departing from the scope of the invention.
For example, as shown in Flgure~7 in which the same elements have the same reference numerals as~in Figure 4, the alarm system 17 is coupled to a drug delivery~system 38 so that the drug delivery system 38, for example, an infusion pump is appropriately controlled according `
~ ~ to the presence or~absence of arrhythmla.~
.;, , .
: :
, ~ :
: ~ :
; 20 3. It provides an alarm ~f a new, pathological cardiac state develops in a patient so~that assessment from an.expert in the art of ECG interpretation may be obtained and/or medical intervention be initiated.
BRIEF DESCRIPTION OF THE DRAWINGS
Further features;and advantages of the present invent~ion become more fully apparent from the detailed description of one embodiment of the invention given~below, when read in conjunction with the accompanying~drawings) wherein~
Figure l is a schematic di~agram of a sensing and analysing system according to one embodiment of the invention;
Figure 2 is a schematic top plan view o~ a sensor patch used in the system o~ Figure~
Figure 3 is a schematic cross-sectional view through the sensor patch of Figure 2;
Figure 4 is a schemat~ic block diagr~am showing a monitoring station used in t~he system of Figure 1~;~
Figure 5 is a flow diagram showing the processing carried out in the monltoring staion of Figure 4;
.
WO 93/19667 PCr~AlJ93/00143 ~ 4 6 ~
Figure 6 is a flow diagram showing the flow of information which occurs when a patient is ~irst presented to the system; and Figure 7 is a schematic block diagram similar to that of Figure 4, showing the alarm system used to control a drug delivery system.
S DETAILED DES~RIPTION OF THE ILLUSTRATIVE EMBODIMENT
There is shown in Flgure 1, in block diagram form, a system for sensing and analysing ECG data sisnals from a patient to determine whether arrhythmia is present, and, i~ so, to produce an alarm. A
patient 1 is provided with a sensor patch 2, of a type to be further described below, which is worn on the skin of the chest. The sensor patch includes a radio transmitter, as well as a power supply, and transmits ECG data signals, conditioned, as necessary, by sultable conditioning circuitry in the se!lsor patch, to a portable monitor unit 3.
The portable monitor unit 3 is designed to be easily carried around by the patient, pre~erably in a pocket, and încludes a receiver for receiving the ECG data~signals transmitted from the sensor patch ;~ 2. The unit 3 also includes circuitry for interfacing with a telephone line 4 to send the ECG data sign~als to a central monitoring station 5 ; 20 by the telephone line 4. The portable unit 3 preferably also has monitoring circultry for monitoring the incoming ECG data slgnal to determine whether there ~is any abnormaiity and to alert the patient if an abnormality in the~ECG data signal is detected.
The central mon~itoring station 5 includes a part & that decodes the ECG data signal~s received from the portable unit 3 via-the-telephone line 4 and~performs beat and rhythm analysis for classification of~the ECG data.~ Periodically, data is reviewed by a ~` professional skilled~in;the fi~eld and a report generated (7~.
Turning now to~Figures 2 and 3, the sensor patch 2 will be further described. The patch 2 is approximately the size of a playing , ;~ card, for example 110 mm long bv 70 mm wide and is approximately lOmm thick. Thus, it~can~be easily worn by a patient without much discomfort. The~patch~comprises a central structur~l support member 8 formed of a~flexible, but r~igld, plastics material, such as Milar. The structural member 8 is surrounded by an adhesive gel 9 which is prefèrably a hydrogel~ compund. The hydrogel compund is a sticky jelly which contains salts~ such~as Sodium and Potassium. Provided the jelly is wet, the pH balance is maintained and the salts migrate between th~
W O 93/19667 ~ ~ ~ 3 ~ 2 4 Pcr/Aug3/oo143 skin of the patient and electrodes attached to the jelly and in contact with the skin. This migration of salts maintains the electrostatic balance and thereby reduces ~rritation. As the water content reduces, the pH and the electrical con~uctivity of the gel is reduced, thereby reducing the salt m~gration. By making sure that the patient wearing the patch has a bath or shower at least once a day, the gel becomes rehydrated and it is expected that such a patch will last and operate continuously for at least a week before its power supply is exhausted an~ it is thrown away.
The patch is provlded with a number of electrodes 10, for example four, which are positioned on the gel 9 so as to contact the skin of the patient when the gel 9 adheres to the skin. A conductive paste may be used between the electrodes and the skin of the patient to improve the electical conductivity therebetween. The electrodes 10 are either metallic, such as stainless steel, or formed of a silver chloride compound and are electrically connected by connections 11 to an ele`ctronic package 12.
The electronic package 12 lncludes a power supply, such as a small cell, circuitry for receiving signals from the electrodes 10, for conditioning the signals to provide a conditioned signal and a short range radio transmitter to transmit the conditioned signa1 to the portable monitor unit 3 which is nearby, and associated support ;~ clrcuitry. Thus, by hav~ng the radio transmitter at the same point as the sensors, the need for electrical signal lines fro~ the sensor to a monitoring unit is avoided. As previously mentioned, the trans~tter need not be radio,~ but could~be microwave~or lnfra-red, if ~n direct line of sight~w1th the receiver in the portable unit.
The eonditioning circuitry~processes the signals from each electrode by filtering the~signals and normalising according to mQasurements made when the respective electrode is disconnected. The normalised signals may also be compared to produce a difference signal representing the differen~ce~in;potential~ sensed by different electrodes. Alternatively, the~normalised signal from each electrode may be transmitted to the~portable unit 3, where such comparisons are undertaken.
~ hen the patient feels discomfort or concern, or if the portable unit gives an alarm, the patient telephones the central monitoring station and downloads the stored data from the portable unit via the W O 93/1s667 PCT/AU93/00143 c~ ~5~ 31~ 8 -standard telephone line. If re~uired, the patient can also transmitcurrent, real time ECG dat~aiso that the it can be evaluated by the centra~ station and any necessary actton can be taken.
Figure 4 illustrates the interconnection of the hardware used at the Central Monitoring Station analysls site.
The modulated ECG signal ~rom the telephone network is demodulated by demodulator 13. The signal is then digitized by an analogue to digital converter 14 at regular sampllng intervals. The digital representation of~the ECG signal is then input to a general purpose digltal computer 15.
he combined gain of the demodulator 13 and analog to digital converter 14 may be automatically adjusted by the demodulator 13, ~' analog to digital converter 14, the computer 15 or by any combination of these three. Connectlons~or automatic gain control between these elements are not shown in figure 4.
The computer 15 processes the ECG: data to decide if a dangerous cardiac event is occurring.~ The ECG data is also processed to extract information which may~be~stored~in such a way that will allow tracking of the state Qf the patient'~s~cardi~ac dis'ease over prolonged periods.
The~storage media'l~6 which can be optical, magnetic or any other type, is used to store the digital representation of the ECG data and information~derived~from it,~as~well às~patient~ident~fication data and clinical information.
When~ the analysi~s~performed'~by~:the computer l;5 indicate that a 25~ dangerous~even~t i's~occurring in~the ECG'currently bèing processed, an a1arm~is~raised~by~the~alarm~system~17. ~h~en an alarm is raised it is env1~saged that~the~stàff~present~at~the analysis site would initiate medical;~intervent~l~on;~to;~allevi;ate'~the~dangerous event.
; The proce~ssi~ng'~of~the ECG da~ta~takes place as shown in figure 5.
In the illustrativé embodiment of the invention, the sampled ECG signal 18 is~initi;ally processed~by;~filters to remove baseline wander and mains~frequency interference 1~9. The~fllters~used in step 19 remove unwanted~b~asellne~wand~er and~ma~lns~frequency~interference without causing~distortlon of~the~shape~of~th~e~underlyi~ng ECG complexes in the 35~ signal.~
The fil'tered signal~is~then proce~ssed at~step 20 to detect R wave points;in`~time in the~ECG~;sl:~gnal~ Portions of the~signal either side of each R~point together witn the R point ltself ~orm a template which : ` : : : : :
WO g3~19667 PCI/AU~3/00143 .~
` - 9~133~2~
is located in the signal by the template location step 21. This template is then processed in comparison step 22.
The compar~son step 22 compares the template in the current ECG
signal, referred to as the test template and produces a number termed a "similarity index". The test template is extracted from the template store 23. If the similarity index produced by the comparison of the current template with the test template is above a predetermined threshold, a match is found. If not, the two templates do not match.
The test template and current template are coherent in time in so far as the R point occurs at the same duration from the start of each template.
The templates which may be used as test templates in the template store are generated for a particular patient when the patient is first presented to the system. Generation of test templates is illustrated in Figure 6.
Referring now to Figure 6, when a patient is first presented to ; the system the patient~s raw ECG signal 30 is again processed (31) by , ~ , the baseline and interference filters. A~representative ECG template i5 automatically generat~ed~32~for~this patient and stored ln the template store 33.~ The representative~template will match most the ECG
complexes in the~patient's fi~rst ECG signal recorded by the system. I~
the patient exhibi~ts normal s1nus rhythm, the representative template wil~l represent a normal QRS~comple~x~w~ith morphological percullarities relevant to the particular~surface lead~u~sed to record the ECG. In a patient that does not~exhiblt normal~sinus~rhythm, the rep~esen~ative template will reflect the~morphological~abnormalities present in most of the patient's~ECG complex~es~
Templates~that~do not match~the representative template are then checked by an~expert in the~field;of~E~G ~i~nterpretation and artifacts are separated (34) from legitimate abnormal complexes. Abnormal complexes exhibit an abnormal~morphology for the patient ~such as, but not limi~ted to Ventricu~l~ar`Ec;topi~c Beats~rom vario~s foci) also can be store~ as template~s.~; The~se~abnormal~templates are then annotated (35) by~the expert with labels~that rçflect;the origin of the abnormal morphology~ The annotated,~abnormal complexes are then stored in the template store 36.
::
Once an initial ECG has~been recorded from a patient, subsequent EGG recordings do not generate~a~new repr~esentative template. The : ~ ;
WO 93/1g667 ~ PCI/AU93/OOt43 1 o - '"
recording of the initial ECG requires an operator skilled in the art of interpretation of ECG signals to ensure appropriate labelling of abnormal templates. Subseq~ènt recordings from a patient do not require the presence o~ an operator with such skills.
Returning now to Figure 5 illustrating the operation of the analysis system when a signal is received from a patient who has previously had an ECG recorded by the system, the comparison step 22 is initially used to compare in-coming complexes w~th the previously generated representative template. When a complex 1s found that does not match the represent~tive template, the comparison step 22 then compares the unknown complex with each abnormal template ~or the patient in turn. In this way, the number of beats that are considered normal for the patient as well as the number and type of ectopic or abnormal beats can be automatically generated at the time that the ECG
signal is being received.
If a complex is found that does not match the representative template nor any of the patient's abnormal templates, it is marked as unknown and at a later~ time can be discarded by the operator if it is considered to be an artifact or used to generate a new abnormal template for the patient. This can be done after the ECG containing the unknown template has been recorded by personnel with ECG
interpretation sk111s. ~ ~
After each complex has been categorized by the comparison algorithm, an arrhythmia detection step 24 determines 1f the patient is experiencing a cardiac arrhythmia. The arrhythmia det0ction step 24 determines the presence~;of~an arrhythmia from the underlying heart rate and the type of beat às determined by the comparison step 22.
If a cardi~ac arrhythmia is detected by the arrhythmia detection step 24, an alarm is ralsed (25) and medical intervention can be instigated by staff at the analysis centre.
.
A parameter measurement procedure 26 i, applied after the .
template comparison step 22. This procedure 26 detects fiducial point, in each complex~that matches the representative template and generates interval parameters relat~ing to the P, Q, R, S and T points in the complex. ~ ~
The ECG signàl is then annotated (27) with the results from the comparison step 22, the arrhythmia detection step 24 and the P, Q, R, S, T location proc~edure 26.
WO g3/19667 PCT/AU93/00143 . -21~! 3 3 ~1 2 4 The annotated ECG is then stored for later review of this analysis period in store 28.
Statistics, such as aver~ge, maximum, and minimum heart rate, numbers of different types of ectopic beats, types and durations of arrhythmic eplsodes and average complex parameter values are generated for the period of ECG analysed in step 29 and stored in store 37.
The stat~stical data and annotated ECG are recorded every time a patient transmits an ECG to the system. The stored information derived by the processing from the ECG's, ECG data itself as well as representative and abnormal templates can be reviewed at a later time.
This information will provide a comprehensive history of the patient's cardiac disease state.
Thus, comprehensive ambulatory surveillance of cardiac sick and high risk patients can be carried out, whilst provlding the patient with a greater degree of freedom than has been possible hitherto. It will, of course, be appreciated that, although only one particular embodiment of the invention has~been described in detail, various modificat~ons and improvements can be made to what has been described without departing from the scope of the invention.
For example, as shown in Flgure~7 in which the same elements have the same reference numerals as~in Figure 4, the alarm system 17 is coupled to a drug delivery~system 38 so that the drug delivery system 38, for example, an infusion pump is appropriately controlled according `
~ ~ to the presence or~absence of arrhythmla.~
.;, , .
: :
, ~ :
: ~ :
Claims (25)
1. A sensor patch for attachment to a patient's body for obtaining physiological data from the patient and transmitting the physiological data to monitoring equipment, the sensor patch comprising a structural support member, sensing means for sensing physiological data from the patient's body, adhesive means for attaching the sensor patch to the patient's body, an electronics package including a power supply and circuitry for processing the sensed data to produce a conditioned signal, communication means for passing the sensed data from the sensing means to the electronics package, and a transmitter for transmitting the conditioned signal from the sensor patch to the monitoring equipment, wherein the electronics package and transmitter form part or parts of the sensor patch itself.
2. A sensor patch according to claim 1, wherein the sensing means comprises a plurality of electrodes for sensing changes in electrical potential of the patient's body.
3. A sensor patch according to claim 2, wherein the electrodes are metallic.
4. A sensor patch according to claim 2, wherein the electrodes are made of a silver chloride compound.
5. A sensor patch according to any one of claims 2 to 4, wherein a conductive paste is provided as an interface between the electrodes and the skin of the patient.
6. A sensor patch according to any preceding claim, wherein the sensing means comprises one or more thermistors to sense the temperature of the patient's body.
7. A sensor path according to any preceding claim, wherein the adhesive means comprises a hydrogel compound which is electrostatically active and rehydrates itself.
8. A sensor patch according to claim 7, wherein the hydrogel compound contains salts which migrate between the skin of the patient and the sensors, thus reducing skin irritation due to maintenance of pH
by the salt migration.
by the salt migration.
9. A sensor patch according to any preceding claim, wherein the transmitter is a radio transmitter.
10. A sensor patch according to any one of claims 1 to 8, wherein the transmitter is a microwave transmitter.
11. A sensor patch according to any one of claims 1 to 8, wherein the transmitter is an infra-red transmitter.
12. A monitoring station for monitoring and analysing ECG
signals from a patient, the station comprising receiving means for receiving raw ECG data signals, first processing means coupled to the receiving means for processing the received raw ECG data to provide a standardised digital signal representative of the ECG data, recognition means coupled to the first processing means for recognising and storing a current characteristic complex in a cardiac cycle of the ECG data, storage means for storing a reference complex from the cardiac cycle of the same patient, comparing means coupled to the recognition means and the storage means for comparing the current characteristic complex stored in the recognition means with the reference complex stored in the storage means and producing a similarity index signal indicative of the degree of similarity between the current characteristic complex and the reference complex, analysing means coupled to the comparing means for analysing a current characteristic complex which has been matched with the reference complex to determine whether cardiac arrhythmia is present in the ECG data, and alarm means coupled to the analysing means for generating an alarm if the presence of a cardiac arrhythmia in the ECG data signals is detected.
signals from a patient, the station comprising receiving means for receiving raw ECG data signals, first processing means coupled to the receiving means for processing the received raw ECG data to provide a standardised digital signal representative of the ECG data, recognition means coupled to the first processing means for recognising and storing a current characteristic complex in a cardiac cycle of the ECG data, storage means for storing a reference complex from the cardiac cycle of the same patient, comparing means coupled to the recognition means and the storage means for comparing the current characteristic complex stored in the recognition means with the reference complex stored in the storage means and producing a similarity index signal indicative of the degree of similarity between the current characteristic complex and the reference complex, analysing means coupled to the comparing means for analysing a current characteristic complex which has been matched with the reference complex to determine whether cardiac arrhythmia is present in the ECG data, and alarm means coupled to the analysing means for generating an alarm if the presence of a cardiac arrhythmia in the ECG data signals is detected.
13. A monitoring station according to claim 12, wherein the reference complex stored in the storage means is a normal complex.
14. A monitoring station according to either claim 12 or claim 14, wherein the storage means stores one or more abnormal complexes of the cardiac cycle of the patient.
15. A monitoring station according to any one of claims 12 to 15, wherein the comparing means compares the current characteristic complex with the or each of the stored reference complexes.
16. A monitoring station according to claim 15, wherein the comparing means first compares the current characteristic complex with a normal reference complex stored in the storage means and, if the similarity index signal indicates a lack of similarity between the current characteristic complex and the normal reference complex, then the comparing means compares the current characteristic complex with one or more stored abnormal reference complex, in turn, until the similarity index signal indicates a match.
17. A monitoring station according to claim 16, wherein, if the current characteristic complex does not match any of the stored reference complexes, then it is considered by a skilled operator and either discarded or entered in the storage means as another abnormal reference complex.
18. An ECG monitoring system comprising a sensor patch according to any one of claims 1 to 11 for sensing and transmitting data representing an ECG signal of a patient, means for receiving the sensed data from the sensor patch at a primary site in the vicinity of the patient and for storing the sensed data, and means for sending the stored data from the primary site to a monitoring station where the ECG
signal is monitored and analyzed.
signal is monitored and analyzed.
19. An ECG monitoring system according to claim 18, wherein the stored data is sent from the primary site to the monitoring station at a central site via the standard voice telecommunications network.
20. An ECG monitoring system according to claim 19, wherein the central site is remote from the primary site and the monitoring station is capable of receiving and monitoring data from a large number of primary sites.
21. An ECG monitoring system according to any one of claims 18 to 20, wherein the means for receiving the sensed data and the means for sending the stored data are within a portable unit.
22. An ECG monitoring system according to claim 21, wherein the portable unit also includes means for monitoring the sensed data to detect an abnormality in the sensed data, and means for alerting the patient that an abnormality has been detected.
23. An ECG monitoring system according to any one of claims 19 to 22, wherein the monitoring station is according to any one of claims 12 to 17.
24. An ECG monitoring system according to claim 18, wherein the monitoring station is according to any one of claims 12 to 17 and the monitoring station is at the primary site.
25. An ECG monitoring system according to claim 24, wherein the alarm means is coupled to a controller of an automatic treatment device for treating the patient.
Applications Claiming Priority (4)
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AUPL1706 | 1992-04-03 | ||
AUPL170692 | 1992-04-03 | ||
AUPL5390 | 1992-10-20 | ||
AUPL539092 | 1992-10-20 |
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CA2133424A1 true CA2133424A1 (en) | 1993-10-14 |
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CA002133424A Abandoned CA2133424A1 (en) | 1992-04-03 | 1993-04-02 | Sensor and system for physiological monitoring |
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EP (1) | EP0636009B1 (en) |
JP (1) | JPH07508185A (en) |
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CA (1) | CA2133424A1 (en) |
DE (1) | DE69329710T2 (en) |
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EP0636009B1 (en) | 2000-11-29 |
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JPH07508185A (en) | 1995-09-14 |
EP0636009A1 (en) | 1995-02-01 |
DE69329710D1 (en) | 2001-01-04 |
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