Surgery – Diagnostic testing – Cardiovascular
Reexamination Certificate
2001-02-21
2003-03-18
Getzow, Scott M. (Department: 3762)
Surgery
Diagnostic testing
Cardiovascular
Reexamination Certificate
active
06535758
ABSTRACT:
FIELD OF THE INVENTION
The invention belongs to the field of medical technology and relates the reading, recording and transmittance of bioelectrical signals of the body or parts of the same for diagnostic purposes, in so far as it is a method for recording and transmitting a multi-channel ECG and an arrangement as a portable recorder for carrying out this procedure. This procedure and this arrangement is part of a telemedical system (ECG—recorder—mobile telephone—evaluation center) which forms the basis for a mobile ECG monitoring system for high-risk patients.
BACKGROUND
Equipment for mobile patient monitoring is mainly known in the form of two differing types of devices, and the associated but differing methods.
The first group of devices includes mobile telephones. Representatives of these are, for example, the technical solutions described in patent specifications EP 0 679 041 A2 and DE PS 197 07 681 C1. The technical solution described in patent specification EP 0 679 041 A2 is solely suitable for determining the location of the patient using his positional data. In the case of the technical solution described in the aforementioned patent specification DE PS, the selected medical data is measured by means of special contacts on the mobile telephone which are fifted to the body of the patient or attached by means of wiring and transmitted over the radio communications network, following which immediate aid measures can be taken. Going beyond the simple determination of the position of the patient as described in the aforementioned EP patent specification, here the current data is transmitted immediately, in contrast to the aforementioned EP solution, in order to identify the patient and/or to record the ECG signals. A disclosure of which, that such an aforementioned mobile telephone independently monitors the patient and in a medically significant event automatically transmits the recorded data over the radio communications network, cannot be proven, in particular, but also just because of this reason, cannot be assumed, as an emergency call button on the device which is to be operated by the patient is specified, which the patient himself can or must operate in threatening situations. It must be noted that the disadvantage of these aforementioned technical solutions is that it is not possible to store and record large amounts of relevant data in the case of monitoring measures conducted uninterruptedly over a long period, for several days, weeks or months. An operating facility for transmitting stored and recorded data to a “central” computer for the purpose of evaluating the time course of the relevant data is also not disclosed. Therefore, in the case of the aforementioned solutions, only the data relating to the normal momentary situation or a special momentary event is transmitted, and not the case history leading up to the event and its subsequent evaluation. Furthermore, these radio telephones differ considerably from conventional devices designed for telephoning, as they are special devices employing special application systems and are for the main part scarcely designed or suitable for conventional telephoning purposes.
The second group of devices includes the recorders. Several types of recorders designed to be worn on the body have become known.
So-called long-term ECG recorders generally record the ECG of the patient continuously, usually over a period of 24 hours, by means of an electronic memory. These recorders with integrated data carriers are then given to the doctor. The data is read out or removed and evaluated at a later time. With so-called event recorders a brief ECG period, usually measured in seconds, is recorded and transmitted in the event of a critical heart event or at predefined intervals. This data is transmitted by telephone using a fixed-network telephone in a complicated procedure. The stored ECG is modulated into an audio frequency enabling it to be transmitted by telephone to an evaluation center.
In the case of so-called event recorders with looping function, an ECG is continuously stored by means of electrodes attached to the body and then repeatedly overwritten after a period of seconds or minutes. If an event occurs the case history immediately prior to the event is herewith stored. The ECG is then transmitted to the evaluation center as in the case of the previous event recorders.
Recently recorders that can be implanted have become known. The internal ECG memory allows data to be stored for up to approximately an hour. The ECG can be read out externally.
The particular disadvantageous technical effects of these aforementioned technical solutions with regard to their arrangement and method characteristics are described below.
Long-term ECG recorders only allow the ECG to be analyzed, and therefore pulse irregularities to be detected, after the data has been recorded. The patient is only monitored for 24 or 48 hours, and control results can only be recognized after a further, considerable delay. Consequently only a diagnosis, also termed a “follow-up diagnosis”, is possible which—in the case of rare events—offers an extremely limited degree of accuracy and which makes the development, for example in the case of medicinal therapy, practically impossible.
Event recorders are designed to circumvent the disadvantage of the “follow-up diagnosis” to as great an extent as possible. ECG events or phases are recorded. However, these are then transmitted to an evaluation center using a complicated and time-consuming procedure, which inherently leads to a reduction in quality and requires a fixed-network telephone with audio frequency modulation. The entire process is extremely difficult to manage, which severely restricts its use in the age group most at risk, if not making it impossible altogether. Furthermore, a real transmission of data is scarcely possible in an emergency situation. The mobility of the patient is restricted by the required fixed-network telephone. The help of a second person is usually required due to the complicated procedure involved, which is very likely to lead to incorrect use under stressful circumstances. Another factor in the case of the first group of recorders is that a brief event is never recorded as the patient himself must first recognize that an event has occurred, and this is then unavoidably only recorded once it has happened. The diagnostic value is therefore extremely limited.
Although implanted recorders require no effort to be operated, they do need to be implanted and must then be replaced after about 1 year. The implantation of a device for diagnostic purposes can only be expected of a small number of very high-risk patients. The costs of an implantation are, of course, very high. Due to their design, implanted devices are only of limited use as event recorders.
The technical solution as described in patent specification DE OS 198 48 229 A1 describes an arrangement for recording and transmitting digitalized medical data for monitoring a patient online, which comprises a data recording component (A) and a “mobile phone unit” (B) combined in a single device. ECG data is sent directly to the RAM memory by the analog-to-digital converter and then from here directly to the mobile phone unit. This means that it is not possible to treat and/or control data, for example in the sense of data compression, as is evident from the two single figures in the specification, see directions of the arrows for the signal path. The technical function must be questioned in accordance with the contents of the disclosure of the specification, as it is pointless to save the A/D converted signals 0.1 without storing a quantity of data ordered and managed by a controller properly and system-compatibly in order to then process and/or use it further. Furthermore FIG. 1, as well as FIG. 2, of the patent specification DE OS 198 48 229 does not allow the contents of the memory to be read directly into a computer (PC). The characteristics named and claimed in the principle claim of this patent specification DE OS support this evalu
Rentzsch Michael
Scharner Wilfried
Getzow Scott M.
von Berg Medizingerate GmbH
Weingarten Schurgin, Gagnebin & Lebovici LLP
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