Patent Application
20070282175
This application takes priority from German Patent Application DE 10 2006 024 988.7 filed 30 May 2006, the specification of which is hereby incorporated herein by reference.
1. Field of the Invention
The present invention relates to a method for automatic registration of a patient-bound medical device with a remote data processing system, as well as a programming device for this purpose according to the preambles of claims 19 and 20, a patient-bound medical device according to the preamble of claim 22, and a data processing system according to the preamble of claim 25.
2. Description of the Related Art
Configurations are used for the continuous monitoring of vital functions of the human body in which a patient-bound medical device performs the measurement of the bodily signals, executes a partial initial processing of the signals, and then transmits this data to a remote data processing and monitoring center. Such a system is described in Published Application WO 03/095024 A2.
Furthermore, it is suggested therein that the patient-bound medical device be equipped with means to retrieve the confirmation of previously stored individuals electronically before the transmission of concrete patient measured data, and check whether a monetary electronic credit balance also stored in the device is sufficient to cover the measured data monitoring service.
For the initial registration of a patient-bound medical device which has just been put into operation with the patient, it is necessary according to the prior art to transmit device identification data, such as the serial number of the patient-bound device, from the physician in the hospital to a user at the central monitoring system by fax or in another way and then input the device identification data of the patient-bound medical device manually into an input form of the monitoring system, to ensure an identification of the system components and/or access authorization on the monitoring system side or on both sides in this way.
Due to this transmission in registration according to the prior art, which is subject to media breakdown and requires a manual input, the disadvantage arises that a disadvantageous time delay arises between the initialization of the patient-bound medical device and its practical readiness for use after completion of the registration procedure, which is caused by the administration effort. The device identification data may additionally be corrupted or lost during the transmission, which requires additional effort for correcting these errors.
In addition, the effort required for inputting the data reduces the acceptance of known devices on the part of the physicians.
It is accordingly the object of the present invention to specify a method and apparatus which allow automatic registration of a patient-bound medical device with a central data monitoring station and avoid the disadvantages cited in the prior art.
This object is achieved according to the present invention by the subject matter of claims 1, 19 and 20, 22, 25, and 28.
The achievement of the object according to claim 1 is represented by a method for automatic registration of a patient-bound medical device with a remote data processing system:
Because the physician identification data is transmitted combined in a registration message together with device identification data by the patient-bound medical device to the data processing system, the data set necessary for the registration procedure with the central data processing/monitoring station is provided secure from manipulation in a way which incorporates rapid and existing infrastructure apparatus and without interposing activity by a human operator which is possibly subject to error. It is possible in this way to automatically check the identity of the patient-bound medical device by the central data processing/monitoring station during all logging in and logging out procedures subsequent to the registration procedure.
Because the physician identification and device identification data is combined in closed form in the registration message, the unique assignment of the identification data to one another is ensured. In addition, the data is brought into a form of a data container in this way which is recognized immediately by the data processing system as a registration message and triggers the registration of the patient-bound medical device in the data processing system after it has been electronically transmitted.
Because the procedure of checking the data contained in the received registration message occurs in the data processing system as a central monitoring station, if necessary, parameter data important for the performing the check may be changed quickly in the system and keeping this data, which is relevant for deciding the registration, consistent is made significantly easier by the central storage of all relevant validation and authentication information. Furthermore, due to the improved possibilities of shielding of the central system, undesired manipulation access to the validation and authentication data may be avoided with less technical effort.
The achievement of the object according to the present invention according to claim 19 is represented by a programming device for programming a patient-bound medical device having at least one interface for transmitting and receiving data and having a memory for storing and retrieving data, means for inputting user data, and means for querying device identification data from the patient-bound medical device, characterized in that the programming device is implemented to generate a data structure from the device identification data and the user data and is also implemented to serialize and transmit the data structure as the registration message to the patient-bound medical device.
Because the programming device according to claim 19 is implemented to generate a data structure made of the device identification data and the user data, it is possible to perform the data processing step of assembling the registration-relevant data in the system component of programming device, which typically, in contrast to the system component of the patient-bound medical device, may be supplied more easily with storage, processor, and power resources. Furthermore, in this way user data, with the addition of personal physician or patient data, may be combined with the device identification data at this point and the registration message produced in the programming device may be transmitted to the patient-bound medical device to be relayed to the remote data processing system.
Both in this context and also in the entire remaining scope of the subject matter suggested in this application, the implementation of apparatus features may be performed as desired by more or less specific hardware and hardware configurations and also by programming apparatus and their interactions.
The achievement of the object according to claim 20 is represented by a programming device for programming a patient-bound medical device having at least one interface for transmitting and receiving data and having a memory for storing and retrieving data, means for inputting user data and means for querying device identification data from the patient-bound medical device, characterized in that the programming device is implemented to generate a data structure from the device identification data and the user data, is implemented to serialize and transmit the data structure as a registration request to a data processing system, and is also implemented to generate and transmit a triggering command for a registration message to a patient-bound medical device.
Because the programming device according to claim 20 is implemented to transmit a triggering command for a registration message to a patient-bound medical device and, in addition, to transmit user data which may contain personal physician or patient data in clear text together with device identification data directly to the remote data processing system at the central monitoring station, it is made possible to transmit a first data packet, which is light in data, as the registration message on a first communication pathway and a second data packet comprising a larger quantity of data as a registration request on a second data pathway.
In this way, advantageously, firstly the reliability of the automated registration is increased and secondly the quantity of the data to be transmitted is tailored to the capacity of the particular data channel transmitting the data.
Both inventions according to claims 19 and 20 share the advantage that a data container tailored to the capacity and the special requirements on reliability and data security of the particular communication channel (registration message, registration request) is generated and filled with data and the data container is thus automatically recognizable and its content is automatically processable.
The achievement of the object according to the present invention according to claim 22 is represented by a patient-bound medical device having at least one communication interface and stored device identification data, characterized in that it is implemented for transmitting a registration message to a data processing system. Typical components of a patient-bound device of this type are an implant, such as a cardiac pacemaker or defibrillator, and a patient device, which is worn by a patient and wirelessly communicates with the implant. The implant also operates basically independently of the patient device. However, the present invention is precisely concerned with the interaction of patient device and implant, so that both devices together are referred to as the patient-bound device.
Because the device is implemented to transmit a registration message to a data processing system, this achievement of the object has the advantageous effect that the patient-bound medical device, in addition to its intrinsic function of measuring and transmitting measured data, is thus also set up to transmit a registration message, which is uniquely recognizable as such, having the data relevant for the registration, to a data processing system, which recognizes the registration message as such and performs the processing of the data contained in the registration message.
The achievement of the object according to the present invention according to claim 25 is represented by a data processing system having at least one communication interface for receiving and transmitting messages and a memory for storing and retrieving data, characterized in that it is implemented to receive a registration message from a patient-bound medical device, to check the data contained therein, and to register and to transmit a confirmation message or an error message to a patient-bound medical device.
The data processing system thus implemented therefore has the advantage that, using system and communication apparatus situated in the data processing system, it may receive and recognize a registration message from a patient-bound device and may check whether the data has been correctly and completely received and whether the registration is permissible as a whole, it may possibly use the data contained in the registration message for the registration and in any case it may transmit back a message about the success of the automatic registration to the patient-bound medical device and the programming device.
The achievement of the object according to the present invention according to claim 28 is represented by a configuration for executing the method for automatic registration of a patient-bound medical device at a remote data processing system according to one of claims 1 through 18 having a programming device according to one of claims 19 to 21, a patient-bound medical device according to one of claims 22 through 24, and a data pro-cessing system according to one of claims 25 through 27.
Advantageous refinements of the present inventions according to claims 1, 19, 20, 22, and 25 are possible according to the particular subclaims referring back thereto and are briefly explained in the following:
The method according to claim 1 may advantageously be refined in that the device identification data is assembled from identification data of individual system components of the patient-bound medical device. In this way, it is made possible in the course of the automatic registration to uniquely identify the individual system components from which the patient-bound medical device may be assembled, such as implant on one hand and patient device on the other hand, and to perform a compatibility check of the system components, for example.
Such a compatibility check is possible according to an advantageous refinement of the method and may be performed by the data processing system. A further advantageous embodiment feature provides monitoring the authorization of the registration procedure on the basis of the physician identification data contained in the registration message during the check of the data contained in the registration message by the data processing system as the central monitoring device.
According to an embodiment variation of the method, the device identification data is first queried by a programming device from the patient-bound medical device and combined with physician identification data stored in the programming device to form the registration message and transmitted by the programming device to the patient-bound medical device. In this way, it is not only possible to transmit the registration message via the intrinsic system communication pathways, but rather the preparation procedures of the registration message are also performed in the programming device, which may typically be provided with more powerful system resources, and which typically contains a better user interface than a patient-bound medical device. In an advantageous embodiment of this variation, further personal data, about physician and patient, for example, or further administration data may be incorporated in the physician identification data. Furthermore, in an advantageous embodiment, the data processing system transmits a confirmation in case of successful registration and an error message in case of failed registration to the patient-bound medical device, by which the intrinsic system communication resources may also be used here bidirectionally for the acknowledgment about the registration process.
In a further embodiment variation of the method, physician identification data is transmitted from the programming device to the patient-bound medical device, for which a key expression is advantageously used. In this way, the volume of the data to be transmitted by the patient-bound medical device and the storage space required in the patient-bound medical device are reduced. This advantage especially appears if the method is implemented in such a way that a command for triggering a registration message is transmitted by the programming device to the patient-bound medical device and the physician identification data is combined in the patient-bound medical device with the device identification data stored in the patient-bound medical device to form the registration message. In this way, a data packet which is light in data is generated where the system-critical device identification data is already permanently stored. In this way, transmission errors are reduced and manual inputs or transmissions of device identification data are avoided.
In an advantageous embodiment of this variation, a registration request is transmitted from the programming device to the data processing system. In this way, via a second communication pathway independent of the patient-bound medical device (e.g., Internet), a parallel registration request provided with additional data may be transmitted, in which device identification data and/or physician identification data and/or personal data may advantageously be incorporated. The method may advantageously be refined in that the data processing system transmits a confirmation directly to the programming device in case of successful registration and otherwise transmits an error message.
If the method is advantageously refined so that the data contained in the registration message is compared to the data contained in the registration request in the data processing system, during the automatic recognition and processing of the registration message in the registration request, the validity of the included data and/or the reliability of the registration is not only established by a comparison to the data centrally stored in the data processing system, but rather the consistency of the data is also ensured by bringing together registration message and request. During the check in the data processing system, it is advantageous in the scope of an advantageous refinement of the method to check whether precisely one registration message has been received for a received registration request (or, vice versa, precisely one received registration request for a received registration message). For the advantageous selection of communication channels in the scope of the method, firstly an infrared connection may be produced between the programming device and the patient-bound medical device (advantageously in the form of a serial IR interface), secondly an Internet connection may be produced between the programming device and the data processing system, and thirdly a mobile wireless connection may be produced between the patient-bound medical device and the data processing system.
To establish the identity and the compatibility of individual system components of the patient-bound medical device, it is advantageous to refine the programming device in such a way that the data structure assembled therein has a first data field for storing the device identification data of a first system component of the patient-bound medical device as well as a second data field for storing the device identification data of a second system component of the patient-bound medical device and further data fields for storing user data, which may include personal data about physician and/or patient, as well as identification data, which is used for the identification as a registration message.
If the patient-bound medical device is advantageously refined in such a way that it is implemented to receive and process physician identification data, and to receive and process a triggering command for a registration message from the programming device, it is possible to receive physician identification data and separately a command for preparing a registration message directly independently. On the basis of the triggering command for a registration message, according to one embodiment of the patient-bound medical device, a data structure is generated from the device identification data and the previously transmitted physician identification data, which may preferably be an alphanumeric character chain, by a corresponding programming apparatus. Furthermore, according to the advantageous refinement, programming means are contained which are implemented to serialize this data structure, identify it as a registration message, and transmit it to the data processing system.
The refinements of the data processing system according to the present invention may be inferred from the claims referring back to claim 25 and the method and apparatus refinements explained above have corresponding advantageous apparatus.
The present invention is explained on the basis of two figures using exemplary embodiments.
In this example, the communication between patient-bound device 1, more precisely: between patient device 12, and data processing system 2 therefore occurs via a mobile wireless connection, while the communication between patient-bound device 1 and programming device 3 occurs via an infrared interface between patient device 12 and programming device 3 and/or a further wireless local connection between implant 11 and programming device 3.
The data processing system 2 has a databank 21, in which manifold different data is stored, such as technical data on types and individual examples of patient-bound medical devices, personal data about physician and patient, the monitored measured data of the vital functions of the patient, or software components for remote maintenance of the patient-bound medical device.
In the scope of this entire patent application and all exemplary embodiments, “personal data” typically identifies alphanumeric character chains situated in multiple fields.
Before, in running operation, the patient-bound medical device 1 transmits measured data via patient device 12 at periodic intervals to the remote data processing system 2 via a mobile wireless connection, as soon as possible after implant 11 and patient device 12 are first put into operation, registration of the patient-bound medical device 1 with central system 2 must occur.
For this purpose, firstly the implant is queried in the bidirectional communication procedure S1 by the programming device 3. In the present case, this is implemented by a local wireless connection, alternatively, however, communication with the patient device 12 via infrared interface is also conceivable, which accordingly relays the information request via a local wireless connection to the implant 11 and correspondingly transmits the queried information received from the implant 11 via the infrared interface to the programming device 3.
After query of the implant 11 (in this case directly via a separate local wireless connection) an infrared connection is produced between the programming device 3 and the patient device 12 in a way not shown in greater detail here. The user data, which, in addition to the personal data of the attending physician also comprises further data about the patient and further useful data, is checked by the physician in the programming device 3 and is confirmed by specification of his user identification, the physician having to authenticate himself by specifying user group, name, and password.
The device identification data 101 queried from the implant 11 in step S1 is then combined in programming device 3 with the user data which contains the cited physician identification data and the remaining data, to form a data structure 102 identified as a registration message, which is transmitted serialized to the patient device 12 in the communication step S2 to be relayed to the remote data processing system 2. The relay of the registration message 102 assembled in the programming device 3 by the patient device 12 is performed in step S3 via a mobile wireless connection (GPRS). The data processing system 2 processes the received registration message 103 by reading out the device identification data, comprising the serial number of the implant 11 and the serial number of the patient device 12, and the physician identification data and further user data and checking whether the user is authorized to register the patient-bound device 1 and whether implant and patient device are compatible with one another. For this purpose, the data processing 2 accesses data stored in data bank 21. If the result of the automated check, in which further technical and administrative information and boundary conditions may be incorporated, is positive, a success message 104a (in case of a negative check result, an error message 104b) is transmitted in communication step S4, which is received by the patient device 12 and relayed via infrared interface in communication step S5 to programming device 3. The programming device 3 outputs a corresponding confirmation or error message on the display screen.
The deregistration, i.e., the final logging out from the running measured data monitoring, may be performed analogously.
If, in this embodiment variation, the method for automatic registration is triggered by the physician on the programming device 3 by actuating a button or a check box, such an operator element, which is only to appear, for optimum support of the physician, when the implant has not yet been registered, in contrast to the embodiment variation shown in
In way not shown in greater detail, the registration command 201b received by the implant 11 is executed in that the physician identification data is combined with the device identification data (the serial number of the implant) stored in the implant 11 and the serial number of the patient device 12, which was previously queried from this device via a bidirectional, local wireless connection, to form a data structure and/or a data container.
In this case, the data container may be brought into a specific form so that it may be uniquely recognized as a registration message. Prefixing a header having an assigned identifier suggests itself for this purpose.
The registration message 205 thus resulting is transmitted in communication step T5 to the patient device 12. The patient device in turn transmits the registration message via a mobile wireless connection in communication step T2 to the data processing system 2.
Alternatively, it is possible that initially a registration message 205 is generated in the implant 11, which initially solely has the device identification data of implant 11 and the device identification data of the patient device 12 is first incorporated after communication step T5 in the patient device 12, before the registration message 202 is relayed to the data processing center in communication step T2. This variation may also be implemented if the connection between implant 11 and patient device is a unidirectional connection from implant to patient device.
Simultaneously or after the transmission and/or program transmission in communication step T1, a registration request 203 is generated in the programming device 3, which contains the same alphanumeric short key 201a as the physician identification data, as was transmitted previously in step T1 to the implant 11. This registration request 203 also contains personal information on the physician and on the patient, as well as the device identification data of the patient-bound medical device 1 (at least that of the implant 11) as well as for the user data having a technical and/or administrative intended purpose. It is transmitted assembled into a data container as a registration request and identified as such similarly as the registration message in communication step T3, in parallel to the registration message transmitted via the mobile wireless connection, via a high-performance and sufficiently secure online connection (e.g., Internet via https) to the data processing system 2. After receiving the registration request, the data processing system 2 expects the registration message corresponding to the registration request within a predetermined time window, e.g., three minutes. Accordingly, if the registration message arrives first, the time window may also be triggered by the registration message, so that the registration request matching the registration message is expected within the time window. Recognizing a registration request or message as belonging to the particular other message is performed on the basis of the particular device identification data contained in the messages.
If precisely one registration request and precisely one matching registration message arrive in the data processing system 2 within the predetermined time window, whose beginning and duration are established by the timer 23, the physician identification data contained in the registration message and the device identification data are checked for correspondence with the physician identification and device identification data contained in the associated registration request. If these data correspond, after any further checking of various technical or administrative conditions, such as the comparison of the serial numbers or the physician identification key with information contained in data bank 21 (such as compatibility information between implant 11 and patient device 12, list of certified physicians), the registration of the patient-bound medical device 1 for the physician, whose physician identification data was transmitted, and the patient device, which has transmitted the registration message, is performed. The device identification data of implant 11 and patient device 12 to be stored in the course of the registration in the data bank 21 is taken from the registration message.
In case of successful registration, in communication step T4 a registration confirmation 204a is transmitted via the online connection between programming device 3 and data processing device 2 and a notification window is displayed for the user in programming device 3, which contains the following information: implant type and device identification data (serial number) of the implant registered immediately previously, physician identification data (physician key) and name of the physician, type and identification data of the patient device; in this way, the physician may check the information again for the sake of security and confirm the procedure on his part by actuating an OK button as a control element. However, if no or multiple registration messages arrive for one registration request within the specified time window, in such a way that the identification data contained matches with one another, an error message 204b is correspondingly transmitted to the programming device 3 by the data processing system 2 in communication step T4, upon which a corresponding error message is displayed in the programming device 3, which contains the causes of the failed registration, instructions for correcting the problem, and the request to repeat the registration.
For the deregistration procedure according to this embodiment variation, a deregistration request is transmitted by the programming device 3 via the online connection to the data processing system 2, this deregistration request being triggered by the physician actuating an operating element on the user interface of the programming device.
| Number | Date | Country | Kind |
|---|---|---|---|
| 10 2006 024 988.7 | May 2006 | DE | national |
