HK1163816B - A measurement system for an analyte determination and a method - Google Patents

Description

Measurement system and method for analyte determination

Technical Field

The present invention relates to a measuring system for analyte determination, in particular for blood glucose determination, and to a method for operating a measuring system for analyte determination.

Background

Such a measurement system is intended to be used by one or more users for determining an analyte measurement value, e.g. a blood glucose value, based on an analysis of a body fluid sample, in particular based on an analysis of urine, saliva, serum, plasma or blood from the individual user. For this purpose, the measuring system has an analysis device for experimentally analyzing a blood sample in order to determine a measured value of the blood glucose. The measuring system usually has a control unit which is equipped with hardware and software components to control the operation of the measuring system, in particular also depending on the detected inputs (the values are input by the user via a user interface of one or more measuring systems). Measurement systems for blood glucose determinations are usually designed as handheld devices.

From document US2009/0138207a1, a portable glucose meter for determining the blood glucose value of a blood sample is known, which is configured for remote data transmission. Glucose meters are known having a patient identification unit, which may be designed with a biometric sensor, for example. A similar device is also described in document US 2007/0231209A 1.

Document US2009/001804a1 discloses an analysis device for analyzing a blood sample, which is provided with user identification based on a fingerprint test in one embodiment, for example. Methods of fingerprint verification are also known from documents US7,116,805 and US7,009,497.

Document 2007/0016104a1 relates to a glucose meter which, in one embodiment, performs user identification by means of fingerprint analysis. The glucose meter has an analysis device for analyzing a blood sample and a user identification method integrated into the analysis device. In operation of the glucose meter, after a successful user identification, the operating parameters are adjusted in accordance with the operating parameters assigned to the confirmed user. The glucose meter may be used by multiple users, which is why this is a multi-user embodiment. By performing user identification, unauthorized persons are excluded from using the glucose meter.

Disclosure of Invention

It is an object of the present invention to provide an improved measuring system for analyte determination and a method for operating the measuring system, by which the individual use of the measuring system is achieved by one or more persons and the efficiency thereof is improved, while the operational cheapness is optimized as a whole.

This object is solved by a measurement system for analyte determination according to independent claim 1 and a method of operating a measurement system for analyte determination according to independent claim 6. Advantageous embodiments of this invention are the subject of the dependent claims.

The invention comprises the idea of a measurement system for analyte determination, in particular blood glucose determination, with an analysis device configured to determine an analyte measurement value, in particular blood glucose, a measurement value of a given body fluid sample (e.g. a blood sample); a fingerprint sensor device configured to detect fingerprint sensor signals for one or more users; and a control device connected to the analysis device (for data transmission) and the fingerprint sensor device, such that the control device is configured to perform user identification using the detected fingerprint sensor signal and, after successful user identification, to enable determination of an analyte measurement value for the identified user using the analysis device, and such that the control device is further configured to optionally analyze additional detected fingerprint sensor signals in addition to the user identification to provide control signals for performing additional measurement system functions.

According to a further aspect of the invention, a method of operating a measuring system for analyte determination, in particular for blood glucose determination, is formed in a single-or multi-user embodiment, wherein a fingerprint sensor device and an analysis device equipped for determining analyte measurement values are connected to a control unit at least for data transmission, so that such a method comprises the following steps: the detection of the fingerprint sensor signal by means of the fingerprint sensor unit, the evaluation of the detected fingerprint sensor signal by the control unit for the identification of the user, makes it possible to feed the determination of the analyte measurement value for the body fluid sample into the unit using the analysis unit after successful user identification and to provide a control signal for performing an additional measurement system function, wherein the detected fingerprint sensor signal and optionally further detected fingerprint sensor signals are additionally analyzed by means of the sensor unit in addition to the user identification.

The invention has the advantage over the prior art that it is possible for the user to use the measuring system individually in a simple and convenient manner, that is to say by touching the fingerprint sensor. In addition to the user identification already provided, the fingerprint sensor signal is analyzed by the control unit in order to be able to obtain a control signal with which an additional function of the measuring system is available. In a second use, i.e. in addition to their analysis in connection with user identification, fingerprint sensor signals are analyzed. The complementary analysis of the fingerprint sensor signal and the provision of the control signal are preferably performed after a successful user identification, independently of taking into account electronic information. This may mean that the control signal is generated independently of the user specific information. Alternatively, it is also possible to provide user-specific information to be taken into account in a supplementary analysis of the obtained control signal together with the fingerprint sensor signal (for example in respect of a particular measuring system function) in which the function is stored or blocked in an retrievable manner for the user by the control unit.

In the supplementary analysis, the fingerprint sensor signal for user identification may be analyzed in whole or in part. It may optionally specify: additional fingerprint sensor signals are detected with the fingerprint sensor device.

One embodiment may provide that: the measuring system is formed by a sample acquiring unit. One embodiment comprises a lancing unit for lancing skin to obtain a blood sample.

By means of user identification based on fingerprint sensor signals, embodiments enable the measurement system to be designed as a multi-user embodiment.

According to a preferred embodiment of the invention, the control unit is further configured to provide, after successful user identification, an analyte measurement value, in particular a blood glucose value (which is determined by means of the analysis unit for the applied bodily fluid sample, in particular a blood sample), a data storage and/or an output assigned to the identified user. The analyte measurement values determined for the identified users are supplied for data storage and/or output in such a way that they can be assigned confirmably to the identified users. For example, the data records assigned to the user are provided with an identifier identifying the user. In connection with data storage, it can be provided that: summaries of the memory areas individually allocated to different users are saved in the control unit. The analyte measured values assigned to the identified users are then stored in the respective memory area and can be read out there again.

In a preferred embodiment of the invention it is envisaged that the control unit is further configured to provide a control signal for controlling the user menu and to control the user menu in accordance with the control signal in a complementary analysis of the detected fingerprint sensor signal in dependence of the detected fingerprint sensor signal. For example, a user menu is displayed on a display screen integrated into the measurement system. In this embodiment the fingerprint sensor signal may be analyzed so that a user navigation in a displayed user menu is detected. In one embodiment, the fingerprint sensor unit is thus embodied as a trackball or trackpad device. In this way, it may also provide the user with the option of: the operating parameters of the operation of the measuring system are defined in the determination of the analyte measurement values by means of the fingerprint sensor unit.

An advantageous embodiment of the invention provides for the control unit to be additionally configured to recognize a finger of the human hand in a complementary analysis of the detected fingerprint sensor signal and to provide a control signal assigned to this finger in dependence on the recognized finger. According to this embodiment, a control signal assigned to an operating function of the measuring system is generated depending on the confirmed finger. For example, it is possible to provide a "prepare to measure mode" function to trigger after confirming the user's index finger. However, if a middle finger of the user is detected, this means, for example, that further use of the measuring system is blocked and thus a mode such as "end of this use" is triggered. The measurement and the respective data storage are then ended. Electronic information about the functions assigned to the various fingers is stored in the measuring system, so that a corresponding control signal can be generated upon confirmation of a certain finger of the hand. The finger-specific determination may be performed on a user-specific basis or independently of a particular user.

According to a further embodiment of the invention, the control unit is further configured such that in a complementary analysis of the detected fingerprint sensor signal, a finger tissue analysis is performed and a control signal for user information is provided in dependence thereon.

In yet another embodiment, the measurement system further comprises an input unit configured to receive a code key, wherein the control unit is further configured to additionally analyze the received code key, enabling determination of an analyte measurement value and/or providing a control signal for performing an additional measurement system function. In this case, fingerprint recognition and combined use of one or more code keys is possible. The code key may also be commonly referred to as a security key. Such devices are preferably used in a multi-mode or multi-role environment. For example, a physician must be authorized to access the system, then allow him to select a pre-installed protocol or mode of operation and give permission to the selected patient to collect data using that protocol. Thus, the operational steps associated with reporting and using the results of the analysis of these data may be limited to the physician and the patient. As an option, after some anonymization, the researcher may be allowed to perform a comprehensive analysis, or an overview analysis of all his patients may be done by the physician. In one embodiment, it is proposed to use a fingerprint sensor unit on the data collection device and a rule set in the software of the collection device and optionally in the software of a personal computer or server for processing the collection date together with one or more code keys. The additional incorporation of a fingerprint sensor into an optional communication device for facilitating data transmission and data management may give additional advantages. This hardware configuration can be used in different use cases: on a single device a doctor can log in and then prepare the device for a patient; alternatively, the device used by the doctor is coupled or paired with a further device. This second device is then prepared for delivery to the patient for data collection. The so-called physician device may not be a collecting device but may be a coupled communication device like a personal computer or likeSmartPix's communications link device, but it contains a fingerprint sensor.

Code key based access methods can be used to organize access rights at various levels that require such multi-mode/multi-user systems to be organized. In one embodiment, the system is turned on by a security or code key and then the fingerprint sensor unit is activated. After all the following required key inputs have occurred, the fingerprint sensor unit is used instead of typing in a long code sequence.

In a multimodal system, a full set of "keys" is required. Fingerprint signals of different fingers may be used to activate different operating modes in the system. For example, after activation by entering a numeric code, the physician scans his finger and the image of the index finger will be used to communicate his activation to the patient for a particular protocol. The patient thus receives permission to use the measurement device for the operating protocol. The doctor can activate the editing function on the collecting device on the protocol, and his particular protocol can be associated with a particular patient if he wants to change the conditions of some protocols to adapt it to the particular patient.

In connection with embodiments of the invention for operating a measurement system for determining an analyte, in particular for determining blood glucose, the explanations given in connection with the embodiments of the measurement system are applicable accordingly.

Drawings

The invention is explained in more detail below on the basis of preferred exemplary embodiments with reference to the drawing. The drawings show:

FIG. 1 is a schematic diagram of a measurement system for analyte determination in a multi-user embodiment, an

Fig. 2 schematically shows a sequence of operation of the measurement system from fig. 1.

Detailed Description

Although the illustrative embodiments are described below based on a measurement system for blood glucose determination from a blood sample, the present invention is not limited thereto. The proposed technique can also be used for other substances and parameters to be detected as well as for other sample fluids, such as serum, plasma, urine, saliva or the like, which are jointly referred to herein as "analytes". Additional analytes in the sense of understanding here comprise not only glucose but also lactate, cholesterol, triglycerides, coagulation parameters (e.g. prothrombin time (rapid value) and the like), among others.

The measurement system may be connected to a server device from which the electronic data may be received. The electronic data may pertain to any operational aspect of the measurement device. Different sets of electronic data received from the server device may be applied depending on the results of the key and/or fingerprint analysis.

Fig. 1 shows a schematic view of a measurement system for blood glucose determination in a multi-user embodiment, i.e. in an embodiment of a device that is allowed to be used by one person or preferably a plurality of different persons. The measurement system is therefore equipped with hardware and software components as explained in more detail below.

In the measuring system, a control unit 1 is connected to an analysis unit 2 for data transmission. By means of the analysis unit 2, a blood sample taken from the user can be analyzed with particular regard to the blood glucose level. The use of such a measurement system by one or more users is possible only if the user is first identified as part of the user identification. For user identification, the measuring system has a fingerprint sensor unit 3, which is coupled to the control unit 1. Each user is identified by placing one or more fingers on the fingerprint sensor unit 3. The identification is successful if, on the one hand, the control unit 1 determines, on the basis of the electronic data stored in the measuring system and, on the other hand, on the basis of an analysis of the detected fingerprint sensor signal, that the fingerprint sensor signal can be assigned to an authorized user. After successful user identification in this way, the measuring system is released for analysis of the blood sample by the analysis unit 2.

The blood glucose values determined as part of the analysis are stored in a user-assigned manner in the storage unit 4 and/or can be used for data output via the data output interface 5, whether for hard-wired data output or wireless data output. Additionally or alternatively, the measured values may be displayed on the display 6. Assigning the determined blood glucose value to the identified user, e.g. by providing the user with an identifier to accompany the data record with the measured value of blood glucose.

In the embodiment shown in fig. 1, the measuring system also has a sample acquisition unit 7, which is configured such that the user acquires a blood sample after a successful user identification. The collected blood sample is then conveyed to the analysis unit 2 and analyzed there, for example along a capillary system.

If a further embodiment comprises a measuring system for determining a further analyte in a bodily fluid sample, the analysis unit 2 and the sample collection unit 7 are in particular designed accordingly. The analysis unit and the sample acquiring unit are known per se in various embodiments and therefore do not require further explanation here.

The measuring system may optionally have one or more additional equipment components 8, which are indicated in fig. 1 by dashed lines. For example, an input unit may be provided, the input unit being configured to receive one or more code keys. In a preferred embodiment, the code key is received in response to a user input.

The control unit 1 is further configured to analyze the detected fingerprint sensor signal by means of the fingerprint sensor device 3 in addition to user identification to supply control signals for other operational functions of the measuring system. This includes, for example, obtaining control signals for a user interface formed with the display 6 and coupled to the control unit 1 for data transmission. For example, the user can navigate in a graphical user menu in this way and can select a function by means of the fingerprint sensor unit 3. In this case, the fingerprint sensor unit 3 is embodied as a track pad device, for example.

Alternatively or additionally, further analysis of the fingerprint sensor signal by means of the control unit 1 may provide for: the control signal is generated in dependence of the type of confirmed finger, such that, for example, a first control signal is generated when the index finger is confirmed, whereas in a complementary analysis of the fingerprint sensor signal a second control signal is supplied when another finger on the user's hand is confirmed. In this case, the control unit 1 has electronic information, which is assigned a certain operating function of the measuring system depending on the type of finger. Thus, electronic information for the allocation between the type of finger on the one hand and the operating function of the measuring system on the other hand is stored, for example, in the memory unit 4.

Alternatively or additionally, code key analysis may be used for identifying different users and/or operating modes assigned to different users. For example, a first primary user, e.g. a doctor, may be identified with the fingerprint sensor device 3. After the identification of the primary user, the measurement system is licensed (clear) for normal operation. Next, the particular user can identify himself by means of the code key. Code key identification may permit the measurement device to be used for the determination of certain analytes.

Additionally or alternatively, the control unit 1 is configured to perform a finger tissue analysis in a larger amount of analysis of the detected fingerprint sensor signal and to obtain a control signal for the measurement system dependent thereon. Thus, a complementary analysis of the fingerprint sensor signal may reveal a large number of lesions of the finger tissue (for which the sensor signal has been detected), which may be the result of frequent blood sampling on the finger. If in the complementary analysis of the fingerprint sensor signal such a situation is confirmed by the control unit, a control signal is generated informing the user via the display 6 that it is advisable to take a blood sample from another finger. Additional or alternative optical signaling in the form of colored lights may also be provided depending on the results of the finger tissue analysis. Thus, the red control display can signal to the user of the measurement system that the finger initially placed on the fingerprint sensor unit 3 is not suitable for taking a blood sample.

In summary, FIG. 2 shows a flow chart of the operation of the measurement system from FIG. 1 in an exemplary embodiment. First, user identification is performed in step 20. If the user identification is successful, the measurement system can be made available to the identified user in step 21. Next, the detected fingerprint sensor signal and/or optionally any additionally detected fingerprint sensor signal is analyzed in step 22 in addition to the user identification to obtain control signals for additional measurement system functions. This may be done before, during, and/or after the blood sample is analyzed. According to fig. 2, in a selected exemplary embodiment a blood sample is analyzed in step 23. The measured blood glucose values thus obtained are then supplied for data storage and/or output in association with the identified user in step 24.

Claims (12)

1. A measurement system for analyte determination, comprising:

an analysis unit (2) configured to determine an analyte measurement value for an applied bodily fluid sample,

a fingerprint sensor unit (3) configured to detect a fingerprint sensor signal for one or different users, an

A control unit (1) connected to the analysis unit (2) and the fingerprint sensor unit (3) for data transmission,

wherein the control unit (1) is configured to perform a user identification using the detected fingerprint sensor signal and to enable, after a successful user identification, a determination of the analyte measurement value for the identified user using the analysis unit (2), and to analyze the detected fingerprint sensor signal and optionally the additionally detected fingerprint sensor signal, in addition to the user identification, after the successful user identification, and independently of the electronic information obtained for the user identification in view, in order to provide a control signal for performing an additional measurement system function.

2. Measuring system according to claim 1, wherein the control unit (1) is additionally configured to provide, after successful user identification, an analyte measurement value which is determined for the applied bodily fluid sample by means of the analysis unit (2), assigned to the identified user for data storage and/or output.

3. Measuring system according to claim 1 or 2, wherein the control unit (1) is additionally configured to provide a control signal for controlling the user menu in a complementary analysis of the detected fingerprint sensor signal in dependence of the detected fingerprint sensor signal for controlling the user menu, and to control the user menu in accordance with the control signal.

4. Measuring system according to claim 1 or 2, wherein the control unit (1) is additionally configured to recognize a finger of the human hand in a complementary analysis of the detected fingerprint sensor signal and to provide a control signal assigned to this finger in dependence on the recognized finger.

5. Measuring system according to claim 1 or 2, wherein the control unit (1) is additionally configured to perform a finger tissue analysis in a complementary analysis of the detected fingerprint sensor signal and to provide a control signal for the user information depending thereon.

6. The measurement system according to claim 1 or 2, further comprising an input unit configured to receive code keys, wherein the control unit (1) is further configured to additionally analyze the received code keys to enable determination of analyte measurement values and/or to provide the control signals for performing additional measurement system functions.

7. A method for operating a measuring system for analyte determination, wherein a fingerprint sensor unit (3) and an analysis unit (2) equipped for determining analyte measurement values are connected to a control unit (1) at least for data transmission, such that the method comprises the steps of:

by means of the fingerprint sensor unit (3) detecting a fingerprint sensor signal,

-analyzing the detected fingerprint sensor signal by means of the control unit (1) to identify the user,

after successful user recognition, an analyte measurement value for the body fluid sample to be applied can be determined with the analysis unit, and

the control signal for performing the additional measuring system function is provided by analyzing the detected fingerprint sensor signal and optionally the additionally detected fingerprint sensor signal by means of the control unit (1) in addition to the user identification after a successful user identification and independently of the electronic information obtained for the user identification being taken into account.

8. Method according to claim 7, wherein, after a successful user identification, analyte measurement values which have previously been determined for the applied body fluid sample by means of the analysis unit (2) are supplied by means of the control unit (1) for data storage and/or output when assigned to the identified user.

9. Method according to claim 7 or 8, wherein the control signal is usable for controlling a user menu in a complementary analysis of the detected fingerprint sensor signal, depending on the detected fingerprint sensor signal, and the user menu is controlled in dependence of the control signal.

10. A method according to claim 7 or 8, wherein one or more fingers of the human hand are identified in the complementary analysis of the detected fingerprint sensor signal, and the control signal is supplied in dependence on the or all identified fingers.

11. Method according to claim 7 or 8, wherein the finger tissue analysis is performed in a complementary analysis of the detected fingerprint sensor signal and the control signal for the user information is supplied in dependence thereon.

12. Method according to claim 7 or 8, wherein a code key is received by the input unit and the control unit (1) additionally analyses the received code key for enabling determination of an analyte measurement value and/or for providing the control signal for performing an additional measurement system function.