Surgery – Truss – Pad
Patent
1995-01-13
1997-03-04
Lateef, Marvin M.
Surgery
Truss
Pad
128696, A61B 50402
Patent
active
056069782
DESCRIPTION:
BRIEF SUMMARY
FIELD OF THE INVENTION
The present invention relates to an ambulatory heart monitoring apparatus and a method of heart monitoring.
BACKGROUND TO THE INVENTION
During the testing of some new drugs, it is necessary to monitor the heart of a patient being treated with the new drug. It is inconvenient for an active patient to be kept in a controlled environment, such as a hospital, during the monitoring. Consequently, patients have been provided with heart monitoring equipment which they may take home with them. Such equipment comprises means for detecting an electrocardiographic (ECG) signal and a device for transmitting the detected signals through the public telephone network. If a patient begins to feel unwell or detects an abnormality in his heartbeat, he must dial a central station and instruct an operator, at the central station, to prepare to record a transmitted ECG signal. This system suffers from a number of disadvantages including the problem of language, since drug trials often take place across national boundaries, the non-availability of telephones and poor quality telephone lines. Also, drug companies are wary of becoming directly involved in patient care which is properly the domain of the patient's physician.
The aforementioned disadvantages may be overcome by replacing the telephone link by data storage media which may be posted to the central station. One known device is the CardioRam produced by Elmed Elektromedizinische Gerate. However, this device records ECG signals for a 24 hour period which makes it unsuitable for drug testing methodologies where intermittent recording is employed over extended periods, e.g. a month.
Another device is known from European Patent Application No. 346685 which is capable of intermittent recording of ECG signals.
None of the prior art IC card ambulatory heart monitoring apparatuses are entirely suitable for the purpose of apparatus embodying the present invention. It is intended that patients will use such apparatus unsupervised. This leads to the problem of ensuring that the patients use the apparatus properly and that the apparatus itself is functioning correctly.
It is an aim of the present invention to provide an ambulatory heart monitoring apparatus which is simple enough to meet the market demand at a reasonable cost, whilst providing high quality information on heart function.
SUMMARY OF INVENTION
According to a first aspect of the present invention, there is provided an ambulatory heart monitoring apparatus comprising: sensor means for detecting an electrocardiographic signal; interface means for receiving an IC card and for transferring data thereto; and control means responsive to operation of the user input means to cause a block of ECG data, derived from signals detected by the sensor means during a predetermined period, to be sent to the interface means for storage in an IC card, characterised by means for producing operation data as a function of an operational parameter of the apparatus wherein the control means causes the operation data to be sent to the interface means for storage in the IC card in association with the ECG data block.
IC card means a card shaped carrier incorporating at least one memory IC and includes smartcards.
The operation data can be characterised as being about the apparatus rather than about the patient. This is data which is useful to determine whether the apparatus is being used properly and functioning correctly.
Advantageously, the apparatus includes means for producing calibration data representive of the calibration state of the apparatus and the operation data includes the calibration data. Such data can be used to normalise ECG data to take account of variations between apparatuses or over time.
Conveniently, the apparatus is powered by a battery and includes battery voltage sensing means and the operation data includes data representing a sensed battery voltage. This data can be used to normalise ECG data, if necessary, or to provide an indication to the person analysing the data that a new battery
REFERENCES:
patent: 4909260 (1990-03-01), Salem et al.
patent: 5086778 (1992-02-01), Mueller et al.
patent: 5343870 (1994-09-01), Gallant
Armstrong David R.
Van Eck Hendrick J. R.
Getzow Scott M.
Hertford Medical Limited
Lateef Marvin M.
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