RU2504003C2 - System and method of managing medical data - Google Patents

System and method of managing medical data Download PDF

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Publication number
RU2504003C2
RU2504003C2 RU2009149426/08A RU2009149426A RU2504003C2 RU 2504003 C2 RU2504003 C2 RU 2504003C2 RU 2009149426/08 A RU2009149426/08 A RU 2009149426/08A RU 2009149426 A RU2009149426 A RU 2009149426A RU 2504003 C2 RU2504003 C2 RU 2504003C2
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Russia
Prior art keywords
data
processing device
system
software application
blood glucose
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RU2009149426/08A
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Russian (ru)
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RU2009149426A (en
Inventor
Даррен БРАУН
Цзюнь Чэнь
Игорь ГОФМАН
Стивен Б. Харрис
Пол Л. ИНМЕН
Ричард КЕЙТС
Цюн ЛИ
Харрис ЛИБЕР
Пол М. РИПЛИ
Грегори СТЕФКОВИК
Хой-Теонг Стив САН
Му ВУ
Раймонд ЯО
Симин ЯО
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Байер Хелткэр Ллк
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Priority to US93228607P priority Critical
Priority to US60/932,286 priority
Priority to US61/012,718 priority
Priority to US61/012,721 priority
Priority to US1271807P priority
Priority to US1272107P priority
Application filed by Байер Хелткэр Ллк filed Critical Байер Хелткэр Ллк
Priority to PCT/US2008/006812 priority patent/WO2008153825A2/en
Publication of RU2009149426A publication Critical patent/RU2009149426A/en
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Abstract

FIELD: information technology.
SUBSTANCE: portable storage device has a data management application which receives and processes data with measurement results from a measuring device which measures an analysed substance. The portable device can use an interface protocol which directly provides compatibility of the portable device with different operating systems and hardware configurations. The data management application is launched automatically upon connecting the portable device with a master computer.
EFFECT: managing medical data using different processing devices without the need for pre-installation of additional programs, clients, device drivers or other program components on separate processing devices.
60 cl, 19 dwg

Description

FIELD OF THE INVENTION

The present invention relates, in General, to a system and method for managing medical data. More specifically, the present invention relates to a portable system that reliably manages information related to a patient’s health, such as blood glucose measurements, and displays this information.

State of the art

Quantitative determination of the content of the analyte in physiological fluids is very important in the diagnosis and treatment of certain physiological conditions. For example, diabetics often check glucose in their body fluids. The results of such tests can be used to dose glucose intake with meals and / or to determine if insulin or another drug is needed.

In diagnostic systems, such as blood glucose monitoring systems, a device, such as a meter, can be used to calculate the glucose content in a sample of a patient’s physiological fluid. The operation of such devices is based on measuring the output signal, for example, current or light obtained by reaction with glucose in a sample. Measurement results are usually displayed and stored by the meter. The main systems provide the user with access to the measurement results directly in the meter using the keyboard or other interactive component.

SUMMARY OF THE INVENTION

A portable data management system has been developed to reliably manage information related to the patient’s health, such as measuring glucose in a blood sample and displaying this information.

In one embodiment of the invention, there is provided a medical data management system comprising a data storage system storing medical data, a data management software application and an initialization program that runs a data management software application in a processing device in which the data management software application processes medical data; and a data transmission interface for transferring data between the data storage system and the processing device, and after establishing communication for data transfer between the data storage system and the processing device, the initialization program launches a data management application in the processing device without first installing an additional device in the processing device a program component associated with a data management software application.

In yet another embodiment, a medical data management system is provided, comprising: a portable device comprising a data management software application that processes medical data, has a first configuration corresponding to an interface protocol and a second configuration adapted for a data management software application; and a processing device connected to the portable device, and after connecting them, the processing device communicates with the portable device according to the interface protocol, and after reconfiguring the portable device from the first configuration to the second configuration, the processing device executes a data management software application.

In yet another embodiment of the invention, a method for managing medical data is provided, according to which: a connection is first established for transferring data between a data storage system to a processing device via a data transfer interface, wherein the data storage system stores medical data, a software application for data management and initialization program; executing an initialization program in the processing device after establishing communication for transferring data between the data storage system and the processing device without first installing in the processing device an additional program component associated with the data management software application; run in the processing device using the initialization program a data management application and process the medical data in the processing device with the data management software application.

In yet another embodiment of the invention, a medical data management method is provided, according to which: a connection between a processing device and a portable device is detected, which comprises a data management software application that processes medical data and has a first configuration corresponding to an interface protocol, wherein after connecting the portable device with the processing device, the processing device communicates with the portable device according to the interface protocol sa; reconfiguring the portable device from the first configuration to a second configuration adapted for the software application; and run the software application from the reconfigured portable device.

In yet another embodiment of the invention, there is provided a system for managing medical data, comprising: a first device storing medical data, a software application for managing data, and an initialization program; a second device that processes medical data using a data management software application; and a data transmission interface for transferring data between the first device and the second device, and after establishing communication for data transfer between the data storage system and the processing device, the initialization program launches a data management application in the processing device without having to pre-install an additional component in the processing device a program associated with a data management software application.

In yet another embodiment of the invention, there is provided a device for managing medical data, comprising: a first part of a housing comprising a data storage system that stores medical data; and a second part of the housing containing a data transmission element that provides data transfer between the data storage system and the processing device by connecting to a processing device processing medical data according to the data management software application, wherein the first part of the housing and the second part of the housing are connected by a cable, which transmits signals between the data transmission element and other components located in the first part of the housing.

In yet another embodiment of the invention, there is provided a device for managing medical data, comprising: a first part of a housing comprising a medical data management system and a data transmission element that provides data transfer between the medical data management system and an external processing device; and a second part of the body, which is connected with the possibility of disconnection with the first part of the body containing at least one component used in the medical data management system.

Other aspects, features, and advantages of the present invention will be apparent from the following detailed description illustrating various exemplary embodiments and implementations, including the best mode of operation provided for implementing the present invention. The present invention can also be implemented in various other embodiments, and its details can be changed in various ways without departing from the essence and scope of the present invention. Accordingly, the drawings and descriptions should be construed solely as illustrative in nature and in no way as restrictive. The invention covers all modifications, equivalents and alternatives that are within the essence and scope of the invention.

Brief Description of the Drawings

1A illustrates a data management system comprising a portable device coupled to a processing device.

FIG. 1B illustrates an example of the data management system shown in FIG. 1A.

FIG. 1C illustrates an example screen of the data management system shown in FIG. 1A.

FIG. 1D illustrates another example of a screen of the data management system shown in FIG. 1A.

Figure 2 illustrates a block diagram of the launch of a software application for managing data from a portable device.

Figure 3 illustrates a data management system comprising a portable device connected to a measurement system.

4 illustrates a data management system comprising a portable device and a measuring system connected to the same processing device.

5 illustrates a data management system comprising a portable device that receives signals from an analytic sensor and interacts with a processor and a user interface of a processing device.

6A illustrates a data management system comprising an integrated device that provides a measurement system and user interface.

FIG. 6B illustrates the integrated device shown in FIG. 6A with a USB interface element.

Fig. 6C illustrates the integrated device shown in Fig. 6A, receiving signals from an analytic sensor for sampling.

Fig.6D illustrates the integrated device shown in Fig.6A, connected wirelessly with processing devices.

7A illustrates a portable device with a USB interface element on an extended cable.

FIG. 7B illustrates a system with the portable device shown in FIG. 7A connected to a processing device.

Fig. 8A shows a view of a portable device with a battery disposed in an end cap.

Figv shows another view of the portable device shown in figa.

Figa shows a view of a portable device with a battery located in the first end cap, and sensor plates located in the second end cap.

Figv shows another view of the portable device shown in figa.

10A shows a view of a portable device with a temperature sensor located in the end cap.

FIG. 10B shows a view of a temperature sensor that can be installed in the end cap shown in FIG. 10A.

DETAILED DESCRIPTION OF THE INVENTION

A portable data management system has been developed to reliably manage information related to a patient’s health, such as measuring and displaying glucose in a blood sample. The proposed data management system is particularly suitable for patients who constantly measure the concentration of glucose and / or other analytes in the blood or body fluids of interest and record the measurement results. Using the proposed data management system, it is easier for patients undergoing frequent examinations to manage the results of their examinations, as well as other medical data. The proposed system can be used with various processing devices in various places, because to work with it essentially does not require the preliminary installation of additional programs, agents, device drivers, or other program components on separate processing devices. A portable device contains software for a data management software application that receives and processes measurement results and other medical data. The portable device may use an interface protocol that is compatible with various types of processing devices operating systems and hardware configurations. The data management software application may be launched in the processing device after connecting the portable device to the processing device.

In a data management system, advanced data processing and display of information by a portable device can also be integrated into a single whole. In this case, medical data can be demonstrated to users in improved ways without running a data management software application on a separate processing device. In addition, the data management system can integrate other functions, such as the analyte measurement function, with a portable device.

Thanks to its mobility, the data management system also solves the challenges of protecting data privacy, such as personal health information. The data management system ensures that all data is stored in a portable device owned by the user and excludes data transfer to other processing devices and the storage of this data on other processing devices. Thus, for the implementation of the interface interaction with the specified portable device, the user can use any public computer on which no data will be left visible to other persons. For better data protection, other security measures may also be taken, such as user authentication procedures. In addition, the proposed system for data management can also ensure the integrity of the data during transmission between the portable device and other devices.

FIG. 1A shows a data management system 10 comprising a processing device 100 and a portable device 200. The processing device 100 may be a desktop or a pinned personal computer (PC), a portable or handheld personal computer (LDC), a compatible personal digital assistant (PDA) , smart cell phone (smartphone), etc. In addition, the processing device 100 may use any operating system and configuration. If the processing device 100 is a desktop or arm-mounted personal computer, the operating system may be a version of Microsoft® Windows®. In another embodiment, if the processing device 100 is a PDA, then the operating system may correspond to the operating systems for PALM® handheld computers supplied by Palm, Inc. or Blackberry® devices supplied by Research in Motion Limited. In general, the processing device 100 comprises a processor 110 that is configured to receive and execute any number of program instructions. In addition, the processing device 100 is typically equipped with a display 120 and a keyboard 130, and / or other input / output elements, which may be external to or combined with other components of the processing device 100.

As described in more detail below, the portable device 200 can be used in combination with host computers that can perform tasks, but which are not fully functional processing devices. Such host computers may have task-adapted devices, such as printers, displays, meters for measuring the analyte in physiological fluids (e.g. meters for measuring blood glucose), and the like. In general, although a specific system configuration for data management can be described, other configurations can be used, including using other host computers, storage devices, and additional components.

The portable device 200 may have dimensions that allow the patient to easily carry, carry and hold it. The portable device 200 may comprise a memory, or a data storage device, 220, such as flash memory, an electrically erasable programmable read-only memory (EEPROM), and the like. Memory 220 may be configured to contain a combination of storage technologies. The memory 220 comprises a data management software application 210 related to a data management system 10. The software application 210 may be a collection of programs or machine codes that receives and processes measurement data and / or other input signals. The software application 210 processes and / or displays this input signal in a manner that is user friendly or selected by the user or others. This information may be used by the user, social worker, attending physician and / or other persons. As indicated above, the measured data may include information on the measurement results of the analyte, including the concentration of glucose and / or other analytes in the blood of the patient or other physiological fluid. Software application 210 may provide improved display and processing of data that may be requested by a user being examined several times a day (e.g., six to ten times a day). For example, software application 210 may include a product similar to the WINGLUCOFACTS® diabetes management program provided by Bayer HealthCare LLC (Territown, NY). In this case, the software application 210 can provide a complete set of tools that receive measurement results from a measurement system for checking blood glucose levels and save them, receive and save other measurement information, such as test time and food markers, record the measurement results in an electronic form, calculate averages and provide another statistical analysis, summarize and provide feedback on the measurement results, provide an adaptable Dr. graphical user interface displayed on the display screen, clear charts and graphs of measurement results, monitor the measurement results compared with the prescribed user permissible restrictions, provide predictive analytics and / or send the data to health workers by fax, email, etc. On figs illustrated screen 120A, which shows the results of measurements of glucose in the blood, taken from the measuring system, in the format of an electronic form, and fig.1D illustrates the screen 120B, which shows similar data in the form of a graphical trend analysis. In addition to the software application 210, the memory 220 may also contain other software.

System 10 is not limited to receiving and processing information about measuring analyte content, such as blood glucose. System 10 may receive data from other systems or devices that measure and / or record medical data and do not require analyte measurements, such as body temperature measurements, blood pressure measurements, heart rate measurements, blood oxygen measurements, breath measurements taken for the purpose of analyzing chronic obstructive pulmonary disease (COPD), weighing performed to analyze the use of furosemide, etc.

Software application 210 may include a combination of programs or components. FIG. 1A shows a software application 210 including a start or initialization program 212 that initializes a data management software application. Launcher 212 can identify the appropriate resources and platform of processing device 100, so that a platform-compatible software application can be selected and run on it. However, the software application 210 may be compatible with at least one platform / operating system. Greater software application 210 compatibility improves system mobility 10.

In addition, the software application 210 may use a device 214 for storing data, such as an embedded database, for receiving and storing measurement results. System 10 resolves issues related to data security, such as personal health information, by providing: (1) storing and processing essentially all of the data on portable device 200, which remains at the user's disposal; and (2) the lack of a constant transmission of readable data from the device 214 to the processing device 100, to which other persons may have access. Thus, to ensure interaction with the system 10, the user can use a public computer on which no data remains visible to other persons. Although the system 10 may temporarily transfer data to RAM or another similar storage device in the processing device 100, the cleanup or completion operation in the software application 210 ensures that any such transferred data is deleted from the processing device 100 after completion of the execution of the software application 210. However, as described below, the software application 210 can be executed directly from the portable device 200, so that no memory, such as random access memory, in the processing device 100 n It will not be used to save, even temporary, any data.

If the user trusts a particular processing device 100 and / or uses it often, the user can register the processing device 100 in the portable device 200 to allow data to be transmitted to the processing device 100. A unique identifier for the processing device 100 by which the portable device can be registered in the portable device 200 200 may recognize the processing device 100 and enable the transmission of data to the processing device 100.

Data protection can also be improved by using a data storage device 214 (eg, an embedded database) that can only be accessed and decrypted by software application 210. In addition, software application 210 can also include programs or components, such as routines user checks that protect the integrity and confidentiality of information. When the software application 210 is launched, a request for a user ID and password, personal identification number and / or other identification information can be immediately generated. Access to data in the portable device 200 is allowed to the user only if his response to the request of the user verification subroutine corresponds to the identification information stored by the system 10. The user verification subroutine can also be used to permit data transfer from the portable device 200 to the processing device 100.

In addition, a memory allocation card may be used in which memory 220 is configured to have several levels of protection. In other words, different levels of access and operations are assigned to memory areas 220, for example, some areas may have more severe restrictions than others. For example, the first level can provide open access for writing, deleting and changing data, and the second layer can be completely unchanged. At the same time, the core of the program, programs in RAM, critical constant data, etc. can be stored in the second level to protect the program and data from damage or deletion.

As described above, memory 220 may be configured to include a combination of storage technologies. Accordingly, the core of the program, software application 210, etc. can be stored in an EEPROM or other primary device. The software application 210 is launched in the processing device 100 from the EEPROM. Meanwhile, the data processed by the software application 210 is stored in a separate flash memory or other storage device in the portable device 200.

As described above, portable device 200 may include a flash memory device, such as a universal serial bus (USB) flash drive or memory card. USB flash drives are also known as flash drives. Memory cards can have various formats, including PC Card (PCMCIA), CompactFlash (CF), SmartMedia (SM / SMC), Memory Stick (MS), Multimedia Card (MMC), Secure Digital Card (SD), xD-Picture Card ( xD), Intelligent Stick (iStick), ExpressCard, their various modifications, etc. Flash memory devices can use non-volatile memory, so that a program related to the software application 210 can be stored in the portable device 200 even if there is no power on the portable device 200. The portable device 200 can use other storage media, such as a floppy disk or optical disc (CD-ROM, DVD-ROM, Blu-ray disc).

In some embodiments, memory 220 in portable device 200 may comprise a run-in-place (XIP) memory, such as a NOR flash (NOR), so that a software application 210 stored in memory 220, can be performed directly without the need for copying into RAM in the processing device 100. Accordingly, the system 10 can provide data protection by the fact that essentially all data is stored and processed by the system 10, operating separately from the portable device, rinadlezhaschego user and that substantially no data is transmitted to other processing devices. Thus, to ensure interface interaction with the specified system, the user can use a public computer on which there is no data visible to other persons.

The portable device 200 may provide interface interaction with the processing device 100 using the convenient plug-and-play (PnP) technology. The interface enables data transfer between the portable device 200 and any processing device 100 and enables the use of the software application 210 with the processing device 100. In particular, the portable device 200 has an interface element 250 that is compatible with the interface element 150 in the processing device 100. Interface element 250 the portable device may be physically connected to the interface element 150 of the processing device to form a hardware interface. In other words, a physical, or wired, connection can be used between the processing device 100 and the portable device 200. FIG. 1B illustrates a portable device 200A physically connected, for example, by insertion, through interface elements 150/250 to a processing device 100A, which is an arm-mounted laptop computer with a display 120 and a keyboard 130. The portable device 200 may be a USB flash drive, and the interface element 250 of the processing device may be a USB connector that is inserted into the USB port, acting as the interface element 150 of the processing device 100. Thus, in the portable device 200 used This is the configuration of a USB mass storage class device (USB MSD), which provides communication between the processing device 100 and the portable device 200 in accordance with a set of standard computing communication protocols. The USB connector on the portable device 200 can be easily inserted into and removed from the USB port in the processing device 100. In addition, mini-USB, micro-USB, or transient devices may be used, for example, between the portable device 200 and the processing device 100. Although FIG. 1A shows a single interface element 250, the portable device 200 may include at least two interface elements 250 that provide connections according to several interface technologies.

Most traditional desktops and knee-high personal computers are equipped with USB ports, and modern operating systems such as Microsoft® Windows®, Mac OS®, Linux and other systems like the Unix system initially support the USB mass storage device standard. Since USB data transfer is initially supported by various devices, it is not necessary to locally install auxiliary tools, agents, device drivers, or other software components in the processing device 100 to communicate with the configuration of the USB mass storage device (USB MSD) of the portable device 200.

The portable device 200 may also be a Secure Digital (SD) memory card with a set of contacts that act as an interface element 250. The processing device interface element 150 may be an expansion slot that accepts the contacts of the memory card. The processing device 100 and the portable device 200 can meet the technical requirements of the SDIO interface (secure digital input and output). Memory cards of other formats having different interface specifications can also be used. However, the use of an SDIO-type interface is preferable since most processing devices such as PDAs, HPCs and smartphones have an expansion slot compatible with the SDIO standard.

In another embodiment of the invention or additionally, the interface elements 150 and 250 can also provide data transmission between the processing device 100 and the portable device 200 via radio frequency communication means (for example, short-range radio frequency telemetry means), such as operating using Bluetooth® wireless technologies, technologies Zigbee, Z-Sense ™, FitSense, BodyLAN ™, and other RF technologies. Radio frequency technologies, such as Bluetooth®, provide wireless connectivity to external devices such as pinned PCs and mobile phones. Other wireless, or so-called “non-physical,” communication technologies, such as using infrared communications, can also be used.

The memory 200 preferably uses an interface element 250 compatible with at least one interface standard or protocol, such as a USB, SD, or Bluetooth® standard. A processing device 100 that utilizes some widespread interface technology is more suitable for interfacing with the storage device 200. Thus, the software application 210 in the portable device 200 can be directly executed in processing devices 100 of various types having different operating systems and hardware configurations, making system 10 more versatile.

The block diagram shown in FIG. 2 illustrates the ability to execute software application 210 stored in portable device 200 on processing device 100. At step 302, processing device 100 is initially connected to portable device 200. As described above, the interface element 150 of the processing device and the interface element 250 of the portable device can establish this connection according to any interface technology. For example, a user may insert the USB connector of the portable device 200 into a USB port in the processing device 100.

As also described above, the processing device 100 may initially support the interface technology of the portable device 200. Thus, in step 304, the processing device 100 can immediately communicate according to the existing configuration of the portable device 200. If the portable device 200 uses a USB MSD configuration and the processing device 100 supports this the configuration, the connection between the processing device 100 and the portable device 200 is established automatically. Due to the widespread use of USB interfaces, there is no need to pre-install additional programs, agents, device drivers, or other software application components in processing device 100 to combine processing device 100 with USB configuration of MSD of portable device 200.

At step 306, the processing device 100 detects the portable device 200. FIG. 1A shows that the software application 210 includes a launch program 212. At step 308, the program 212 can be started immediately after the processing unit 100 detects the portable device 200. The program 212 can be started automatically or after data is entered by a user, another person, or another component. Many operating systems support an autorun feature that allows the system to take some action immediately when inserting removable media such as CD-ROM, DVD-ROM, or flash media. Processing device 100 may use a version of the Microsoft® Windows® operating system that supports the automatic start or auto play function to automatically start program 212. For some processing devices 100 that use, for example, the Microsoft® Windows® operating system, portable device 200 may first declare to the processing device 100 that it is a non-removable device before the autostart function of the operating system is activated for Program Updates 212.

At step 310, program 212 reconfigures the portable device 200 from the initial USB MSD configuration to a new configuration adapted for software application 210. At step 312, the new data management configuration allows the data management software application to start and work in combination with processing device 100. Configuration for data management also supports related functions, such as updating data management in the device 214.

Reconfiguring portable device 200 from a more versatile USB MSD configuration to a specialized data management configuration may block or block other software applications contained in processing device 100 from accessing files and data contained in portable device 200, and thereby increase system security 10. If processing device 100 uses the Microsoft® Windows® operating system, a Windows® Explorer program that creates a graphical user interface for accessing file systems does not have access to files on portable device 200, while portable device 200 is reconfigured specifically for a data management software application. This reconfiguration can be performed automatically when the portable device 200 is connected to the processing device 100, which prevents unassigned software applications contained in the processing device 100 from accessing any data contained in the portable device 200.

Thanks to the plug and play functions of the interface interaction of the processing device 100 with the portable device 200, these devices can be connected or disconnected by the user at any time. At the same time, the system 10 ensures that the data or software application contained on the portable device 200 is not damaged during the connection or disconnection of the portable device 200 with the processing device 100. To ensure successful transmission and storage of data, checksum and / or transaction completion routines can be used , which improves the storage of information whole. In addition, as described above, when the portable device 200 is disconnected, the software application 210 may perform a cleanup or terminate operation with the deletion of all data temporarily stored in the processing device 100, for example in main memory, and gradually shut down.

Although the portable device 200 and the software application 210 stored therein can be compatible with most processing devices 100 having various operating systems, however, the system 10 can also use another processing device 100, which acts as a base station. The portable device 200 may be connected to the processing device of the base station using the interface technologies described herein. The processing device of the base station can provide a data archive for long-term storage of data downloaded from the portable device 200. In addition, in the processing device of the base station can be launched from the portable device 200 the main version of the software application for data management. For example, the processing device of the base station may be a personal home computer.

In addition, the portable device 200 may be provided with an expansion port that can receive additional devices, such as an SD memory card. The interface of this expansion port works like the other interfaces described in this specification. In particular, this interface can use the SDIO interface to receive an SD card. Additional memory on the SD card can be used to store a large database of measurement results.

In addition to storing data such as measurement results received from a blood glucose measurement system and other medical data processed by the software application 210, the portable device 200, by virtue of its mobility and compatibility, can function as a portable device containing medical records. Moreover, the portable device 200 can be used to facilitate the use of important information in conjunction with emergency medical personnel, doctors, other medical personnel, etc.

In a particular embodiment, portable device 200 may provide important information during emergencies. If the user is unconscious or otherwise unable to contact the guardian, the guardian can connect the portable device 200 to the processing device 100 via the interface element 250, and after starting the application 210, important information may appear in a pop-up window or an initial window. Such functionality is possible due to the high compatibility of the portable device 200 with various processing devices 100, and the guardian does not need to pre-install software components in the processing device 100 to run the software application 210.

In some cases, the software application 210 may be distributed among health care facilities, so that data in the portable device 200 can be accessed, if allowed, using the software application 210 installed in the processing device 100 of the medical institution, for example on a personal computer. In order to ensure security, the data can be encrypted so that they can be read in the processing device of the hospital only using the decryption key. If an instance of the software application 210 is already running in the processing device 100, the software application 210 on the portable device 200 may be prohibited from starting to prevent the simultaneous operation of two instances of the software application 210. Since the portable device 200 and the processing device 100 may have different versions of the software application 210 , you may need to agree on different versions. Different versions of a software application can organize and store data in different ways and / or receive data in different formats. In other words, the structure of the device 214 and the types of data stored in it may depend on the version of the software application 210. For example, if the treatment facility of a medical institution uses a newer version of the software application 210, then this newer version can be developed with backward compatibility old versions of the software application 210 and can work with data stored in the portable device 200. However, if the processing device 100 of the medical institution uses the old version of the program Upgrade Binaries application 210, the job of the old version of the software application 210 may be stopped, and a newer version contained on the portable device 200 can be run in the processing unit 100 hospital. Other matching technologies of different versions may also be used. For example, a software application 210 can be designed to provide a basic set of functions that always work the same and structure the same data for certain basic types, for example, the results of measuring the content of an analyte in a physiological fluid, so that at least some aspects of the software application 210 remain unchanged , and in this way, forward and backward compatibility can be ensured.

In general, the types of data that can be stored and shared with others, such as hospitals, include, but are not limited to: information about the name and address; control data of the patient's condition (information from the medical record, data of daily monitoring of chronic diseases and measured parameters, measurement results collected over the past 12 hours, etc.); data on concomitant diseases; information on the last dose of insulin or other medication taken; name of the attending physician and his contact details; information about recent visits to the doctor; death will; disability information; insurance information; allergy information and other user-provided information. In another embodiment of the invention or in addition, information may be provided on a label or other marking affixed to the portable device 200.

Only the user controls the information that is shared through the portable device 200 to preserve the privacy of his privacy. For greater control over shared data, software application 210 may provide several levels of access so that certain types of data are available only to specified individuals / organizations. For example, only ambulance personnel can access information such as medical information and data that is usually printed on a medical bracelet. In other words, the software application provides the implementation of the most basic functions, for example, displaying a single pop-up window, to provide less confidential personal information to persons who do not have access of a higher level. In this case, the attending physician may have the right to access more confidential information related to the health of his patient. In addition, higher-level access can be granted to relatives or close people, such as the parents of a child with diabetes.

As described above, the portable device 200 may have several interfaces 250 for connecting and communicating with various devices. In addition to connecting to a processing device 100 to launch a software application 210, as described above, the portable device 200 can use its communication capabilities to remotely connect, for example through a network, to external systems to provide the user with a wider range of functionalities and services. In some embodiments, these external systems can act as the host host that controls the connection of the portable device 200 to such external systems. Such external systems may act as a software application 210 or other components of a software application stored on the portable device 200 to provide communication between the portable device 200 and external systems. In another embodiment, these external systems can locally store the necessary components of a software application.

Accordingly, the portable device 200 may be connected to an intermediate device, such as a personal computer having access to the Internet, or a mobile communication device with access to a cellular network, for remotely transmitting data to other persons, for example, hospitals. In this case, the user does not need to connect the portable device 200 directly to the processing device 100 of another person for data sharing. Thus, the medical data stored on the portable device 200 can be easily shared with other persons, including health workers, who may be located in remote or remote areas. This feature of the invention can be especially useful for users who are unable to attend medical facilities due to health problems, distance, cost, etc. In addition, this feature of the invention increases the ability of a medical institution to monitor the user's medical data more often and immediately in urgent cases. Data transfer may be controlled by an intermediate device, which may comprise a processor for executing respective software application components stored in the intermediate device or portable device 200.

In addition, portable device 200 may be connected to an intermediate device for in-place updating of data and / or software application stored on portable device 200. For example, portable device 200 can easily receive an updated / patched version or even a complete new version of software application 210 by Connect to a remote boot server via a network computer or mobile communication device. In another example, portable device 200 may receive new or updated program application execution parameters on portable device 200. In some embodiments, new programs or functions of system 10 may be received, for example, purchased from a remote boot server. Additional features for customizing or personalizing the graphical user interface for the data management software application can be accessed through a system accessible over the Internet. To ensure the integrity of the data and the software application on the portable device 200, data or a software application downloaded in an in-place update mode can be approved before being used on the portable device 200. For example, to confirm a complete and successful download of the data or software application, checksum verification routines. An in-place update may be controlled by an intermediate device, which may include a processor for executing the respective software application components stored in the intermediate device or in the portable device 200. In another embodiment of the invention or in addition, the portable device 200 may include a processor that can locally execute program application components in order to manage the in-place upgrade aspects. For example, the processor in the portable device 200 may provide information integrity on the portable device 200 according to a data update file (DUF) or other component that ensures a successful download of a software application. For additional data protection, an update file with data encryption / decryption can be used.

As described above, embodiments of the portable device 200 may use a USB interface to connect to various devices. In traditional systems, a USB interface provides communication between the processing device and peripheral devices, the processing device acting as a master computer and USB-enabled peripherals acting as slaves. In general, when using the USB standard, only the host computer with USB can initiate data transfer to the connected USB peripheral device, and the USB peripheral device can only respond to commands from the host computer. Thus, a USB-enabled peripheral device cannot connect to other USB-enabled peripherals via peer-to-peer communication. FIG. 1B shows a processing device 100, which is a knee-high personal computer acting as a host computer, and a portable device 200 acting as a peripheral device. When the software application 210 is started in the processing device 100, the processing device 100 controls the execution of the program instructions and any data transfers on the portable device 200 using the software application 210.

However, in other embodiments, portable device 200 may include processing functions that enable it to act as a host computer. Thus, the portable device 200 is not limited to the role of the slave device as a peripheral device supporting the USB standard. In other words, the portable device 200 can communicate with a wide variety of peer-to-peer devices, including devices that are commonly considered peripheral devices.

For example, portable device 200 may use the specifications of the USB 2.0 standard and USB OTG (a standard for peer-to-peer connection of USB peripherals without connecting to a host computer that does not require drivers to be installed), which is in addition to the USB 2.0 specifications. Functionality according to the USB OTG standard enables the portable device 200 to be connected to other devices that support the USB OTG standard. When two devices with USB OTG functions are directly connected to each other, the communication protocol with the host computer (NHP) allows either of these two devices to act as the host computer. NHP also allows these two devices to exchange their master and slave roles. When physically connecting two devices that support the USB OTG standard, one of the devices assumes the role of the host computer and supplies power to the USB bus with a vbus voltage and a current of 8 mA for connecting between the two connected devices according to the USB standard. Session Request Protocol (SRP) can be used to request the host computer to power on the USB vbus. Communication between the two devices is bidirectional or duplex, and in this way, information can be exchanged between the two devices. Such communication can provide both a low transmission rate (approximately 1.5 Mbit / s), a normal transmission rate (approximately 12 Mbit / s), or high speed (approximately 480 Mbit / s). Preferably, the USB OTG functionality is configured for use with battery powered devices and minimizes power consumption. In this regard, USB vbus power can be turned on or off by the host computer using SRP.

It should be noted that if the portable device 200 shown in FIG. 1A, which contains functionalities that support the USB OTG standard, is connected to a processing device 100 (not supporting the USB OTO standard), the processing device 100 and the portable device 200 can communicate using a conventional protocol USB standard, and the processing device 100 will generally act as a host computer, as described above. Other portable devices may use communication protocols that provide benefits similar to those of the USB OTG standard.

By using the USB OTG standard, the portable device 200 can be directly connected to a printer that supports the USB standard, and data from the portable device 200 can be printed automatically. The portable device 200 can dynamically create print-ready or printable files and can transfer these files to the printer via a USB connection.

For the portable device 200 to communicate with another device, device drivers and / or other software application components may be needed. For example, you might need a printer driver to print data sent to the printer. Thus, for printing files, portable device 200 can save and use a printer driver when connecting portable device 200 to a printer to print data. Since the installation of additional device drivers and / or other components of the software application on a portable device 200 that supports the USB OTG standard may not be possible after the manufacture of the portable device 200, the portable device 200 may only be compatible with a pre-selected set of devices whose drivers were installed on the portable device 200 during manufacture. The list of compatible devices can be stored in the portable device 200 with the possibility of determining the compatibility of the portable device 200 with this device.

In another embodiment, the first portable device 200 that supports the USB OTG standard can communicate directly with the second portable device 200, one of the portable devices taking on the role of a host computer (host computer). Also, in one embodiment, when a user wants to replace an old portable device with a new portable device, the data and configuration contained in the old portable device can be easily transferred directly to the new portable device. In another embodiment, functionalities located on the first portable device 200 may be used in conjunction with the second portable device 200, or vice versa. For example, the second portable device 200 may include USB interface elements, as well as an RJF wireless radio protocol, which is not present in the first portable device 200. However, if the first portable device 200 is connected to the second portable device 200 via a USB interface, then the first portable device 200 may have access by wireless radio frequency protocol, which is equipped with a second portable device 200.

Data, for example, blood glucose concentration measurements received from a measuring system, can be received by system 10 in accordance with various technologies. As the above disclosure of the USB OTO standard shows, portable device 200 is not limited to the choice of interface type for communicating with processing devices to launch a software application. Thus, as shown in FIG. 3, the portable device 200 can be connected directly to the measurement system 20 to provide data download from the measurement system 20 directly to the portable device 200.

FIG. 3 shows an exemplary measurement system 20 comprising a meter 500 with a port 502 for taking and analyzing a sample of physiological fluid using an analytical sensor 400. The analytical sensor 400 is configured to take a sample of physiological fluid, which is analyzed using a meter 500. Suitable substances for analysis include glucose, lipid profiles (e.g., cholesterol, triglycerides, LDL and HDL), microalbumin, Alc hemoglobin, fructose, lactates or bilirubin. It is possible to determine other information about the analyzed substances (for example, their concentration). The analytes may be contained, for example, in a whole blood sample, a blood serum sample, a blood plasma sample, other physiological fluids such as IL (interstitial fluid) and urine and in non-physiological fluids.

The analytical sensor 400 includes a fluid space for introducing a sample of physiological fluid into it. For example, to puncture a finger or other part of the body to obtain a blood sample on the surface of the skin, the user can use a lancet or a scarifier. The user can then collect this blood sample by bringing the analytical sensor 400 into contact with the sample. The liquid space may contain a reagent that reacts with the sample to show the concentration of the analyte in the sample.

The analytical sensor 400 may be an electrochemical sensor. An electrochemical analytical sensor typically includes several electrodes and a liquid space containing a certain enzyme. The liquid space contains a reagent designed to convert an analyte (e.g., glucose) in a sample of a liquid (e.g. blood) into a chemical compound that can be measured electrochemically by the electric current generated by the components of the electrode circuit. The reagent typically contains an enzyme, including, for example, glucose oxidase, reacting with the analyte and an electron acceptor, for example, a ferricyanide salt, to form a compound that can be measured electrochemically and detected by electrodes. Other enzymes can be used to react with glucose, including glucose dehydrogenase. In the general case, the enzyme is chosen so that it reacts with the desired analyte or substances in such a way that it helps to obtain information related to the analyte (for example, its concentration) in the liquid sample. If it is necessary to establish the concentration of another analyte, a suitable enzyme is selected for the reaction with it.

In another embodiment, the analytic sensor 400 may be an optical analytical sensor. In measuring systems based on optical sensors, technologies such as transmission spectroscopy, absorption spectroscopy, diffuse reflection, fluorescence spectroscopy, resonance fluorescence energy transfer, combinations of this and others, can be used to measure the concentration of the analyte. The indicator reagent system and the analyte in the sample of physiological fluid react with a change in the permeability of light, which is directed to the sensor 400. The degree of change in light permeability is an indicator for the concentration of the analyte in the physiological fluid.

Some commercially available analytic sensors that can be used include those supplied by Bayer HealthCare LLC (Territown, NY). These analytical sensors include, but are not limited to, Ascensia® CONTOUR®, Ascensia® BREEZE® and BREEZE®2, Ascensia® Elite® and Elite® XL used in blood glucose monitoring systems. Other analytical sensors, in addition to those mentioned above, can be used in the methods and systems of the present invention.

3, meter 500 receives and uses an analytic sensor 400. Meter 500 measures the concentration of an analyte in a sample collected by analytic sensor 400. Meter 500 may have electrode contacts for detecting an electrochemical reaction of an electrochemical analytical sensor. In another embodiment, the meter 500 may include an optical signal detector for detecting a degree of change in light permeability by an optical analytic sensor. To calculate the actual concentration of the analyte obtained as a result of the electrochemical or optical reaction measured by the meter 500, and, in general, to control the sample measurement procedure, the meter 500 uses at least one processor 510 that can execute program instructions according to the measurement algorithm. Data processed by processor 510 may be stored in memory 520. In addition, the meter may have a user interface 570 that includes a display (eg, a liquid crystal display and the like). Buttons, a scroll wheel, touch screens, or a combination thereof can also be provided as part of the user interface 570 to enable the user to interact with the meter 500. The display usually displays information about the measurement results, measurement procedures and / or information in response to commands entered by the user,

Although meter 500 can store measurement results and provide a user interface 570 for displaying measurement results, software application 210 on portable device 200 provides more advanced functionalities for managing, processing, and displaying measurement results and related information. Thus, the measurement-related data collected by the meter 500 can be downloaded to the portable device 200 for processing by the software application 210. In FIG. 3, the meter 500 includes an interface element 550 that allows the meter 500 to be connected to the portable device 200 through the portable interface element 250 devices.

The meter interface element 550 and the portable device interface element 250 may use the interface technologies described above. Portable device 200 may be connected to meter 500 via a USB interface. Transferring data between the meter 500 and the portable device 200 may require the use of a host function, such as a USB host function, on the portable device or meter 500, which contains the processor 510. Also, the portable device 200 or the meter 500 controls the download of data to execute the respective components of the software application stored on the meter 500 or portable device 200. The transmitted data, for example, a series of read results of measuring the concentration of glucose in a blood sample, can be provided time stamps or serial numbers to ensure proper storage and analysis of data by portable device 200.

In addition to the interfaces described previously, other communication protocols may be used to transmit data through the interface elements 250 and 550. For example, an interface for transmitting data from the meter 500 to the portable device 200 may be provided with radio frequency identification (RFID) technology. In particular, the interface element 250 in the portable device 200 may include an RFID antenna and an RFID circuit. In this case, the interface element 550 in the meter 500 may include an appropriate RFID circuit for scanning the meter 500 with a portable device 200 for the purpose of transmitting data, such as read results of blood glucose concentration measurements, to a portable device 200. In the case of using the RFID interface, a transmitter, for example meter 500 consumes less power, and a receiver, such as portable device 200, consumes more power.

In some embodiments, the amount of data that can be transferred at a time is from about 56 KB to 256 KB, which corresponds to about 100 read results of measuring glucose concentration in the blood.

RFID technology can be used to transfer data between portable device 200 and any other device, such as processing device 100. As described above, processing device 100 can be a base station processing device or a hospital processing device. Since these processing devices may already contain the software application 210, it should not be launched from the portable device 200, and only the stored data, such as data associated with the read results of measuring the concentration of glucose in the blood, needs to be transferred to the processing device 100. In this embodiment, the interface element 150 in the processing device 100 comprises an RFID antenna, since the processing device 100 acts as a receiver, while the portable device 200 acts as a transmitter. Preferably, in this embodiment, less power is required for the portable device 200.

The portable device 200 may be equipped with a power source, such as a battery 260, which can be recharged through a connection with a processing device 100 or other external device having a power source. For example, energy can be transferred via a USB connection between the processing device 100 and the portable device 200. When the portable device 200 and the meter 500 are connected together, the battery 260 can be used to recharge the battery 560 that powers the meter 500, or vice versa.

As described above, the portable device 200 may be connected to an intermediate device for receiving in-place updates to data and / or software applications stored on the portable device 200. The portable device 200 may also be used to update or supplement the software application in the meter 500. In an exemplary In an embodiment, a new or updated version of the software application for meter 500 may be downloaded to portable device 200. This may be done after connecting the portable device. -OPERATION 200 to a remote download server via a computer with access to the network, or a mobile communication device. Then, a new or updated version of the software application can be downloaded to the meter 500 after it is connected to the portable device 100. The portable device 200 or the meter 500 can control this download process.

In Fig. 4, the data collected by the measuring system 20 shown in Fig. 3 can be downloaded by connecting the measuring system 20 to the processing device 100 through the interface element 155 of the processing device, while the portable device 200 is also connected to the processing device 100. Then data can be downloaded through the processing device 100 to the portable device 200. Communication interface technologies can be used to connect the measuring system 20 and the processing device 100 described above. For example, the measurement system 20 may be received at a second USB port in the processing device 100. In addition, the software application 210 operating in the processing device 100 can be used to provide or facilitate data transfer from the measurement system 20.

Figure 5 illustrates another portable device 1100, which combines the components and functions of the portable device 200 with the components and functions of the meter 500. In particular, the portable device 1100 includes a memory 220 that stores a software application 1110 that can be run in the processing device 100 without pre-installing the components of the software application in the processing device 100. The software application 1110 includes a start-up program 1111 that launches the software application 1110 in the processing m device 100 in the manner described above. In addition, memory 220 may include a data storage device 1112, such as a database, that stores data collected or processed by software application 1110. Memory 220 may include a USB flash drive, memory card, or the like. The portable device 1100 also has an interface element 250 that can be connected to the interface element 150 of the processing device 100 using USB technology, an radio frequency protocol, and the like.

In addition, portable device 1100 may include a port 502 for receiving an analyte analyzer 400 of an analyte. A sample, such as a blood sample, can be collected by an analytical sensor 400 and analyzed as described above to determine the concentration of the analyte, for example, the concentration of glucose in the blood. The software application 1110 includes software instructions for performing a sample analysis received by the analyte analyzer 400 of the analyte. Essentially, when the software application 1110 is run in the processing device 100, the processor 110 in the processing device 100 executes the software application 1110 that collects and analyzes information about the electrochemical or optical reaction of the sample with the reagent in the measuring sensor 400. After the processor 110 determines the results of the analysis of the sample in the measuring sensor 400, the processing device 100 may display the measurement results on the display 120 of the processing device 100. Accordingly, the portable device 1100 and about the abutting device 100 is integrated into a measuring system, such as a blood glucose concentration meter, in which the portable device 1100 includes a port 502 for detecting a reaction in the measuring sensor 400, and the processing device 100 analyzes the reaction using a software application 1110 contained in the portable device 1100, and displays the measurement results. Additionally, the software application 1110 may include the functions of the software application 210 described above to improve data processing and display on the display of the processing device 100.

The memory 220 of portable device 1100 can include a Secure Digital (SD) card, and portable device 1100 can connect to a processing device 100, such as a PALM® PDA or Blackberry® device, through an SDIO (Secure Digital Input and Output) interface. Thus, the portable device 1100 can be in the form of an SD card with a port 502 for receiving an analytic sensor 400, and the SD card can be inserted into the processing device 100 to form a measurement system. In another embodiment, portable device 1100 may include other types of memory and may connect to a processing device using other technologies, such as Bluetooth® wireless technologies.

Additionally, the software application 1110 can be based on the Java programming language so that the portable device 1100 can use a web browser, commonly found on most operating systems, to implement, using the HTML language (hypertext document description language), an external user interface for a software application 1110. The Java-based software application 1100 is generally preferably independent of the type of operating system, and most devices, such as a PALM PDA ® or Blackberry® device, use web browsers. Thus, portable device 1100 provides a fully compatible and mobile technology for converting a set of devices into a measurement system, such as a blood glucose meter. In general, the software application launched by the portable devices described above can also be Java-based programs that are executed by web browsers and similar broadcast software applications.

Like the portable device 1100 shown in FIG. 5, the integrated device 600 shown in FIGS. 6A-6D combines the components and functions of the portable device 200 with the components and functions of the meter 500. Accordingly, the integrated device 600 can receive an analytic sensor 400 through port 502. In addition, the integrated device 600 also includes a processor 610, which calculates the concentration of the analyte in the sample collected by the analytical sensor 400. In contrast to the portable device 1100 for integrated device 600 there is no need to calculate the concentration of the analyte by the processor 110 of the separate processing device 100. Instead, information about the results of determining the reaction between the sample and the reagent in the measuring sensor 400 is processed by the processor 610 of the integrated device 600. The measurement results are stored in the memory 220 of the integrated device 600. memory 220 may have a capacity in the range of about 500 MB to 2 GB.

In addition, the integrated device 600 includes a user interface 670 that can be used to display measurement results and enter commands for various display options. In particular, the user interface 670 provides additional convenience and mobility of the system 10 by combining the functionality of the portable device 200 with advanced data processing and display functions. As a result, the integrated device 600 combines the portable device 200 and the user interface 670, as well as the components and functions of the meter 500.

Thus, as shown in FIGS. 6B and 6C, the integrated device 600 may be a portable blood glucose concentration meter that performs data processing and display functions. Users can use the integrated blood sampling device 600 with an analytical sensor 400 and have access to more complex representations of blood glucose measurements obtained with the integrated device 600 without running a data management software application on a separate processing device 100.

However, since the hardware limitations may still impede the use of all the functionalities inherent in the integrated device 600, it can also run a data management software application on a more powerful processing device 100 and provides the user with functionalities not present in this integrated device. FIG. 6D shows an integrated device 600 wirelessly coupled to at least two processing devices 100 including an arm-mounted personal computer and mobile communication devices.

As described above, the integrated device 600 can communicate with the processing device 100 and transmit data to it without necessarily starting the software application 210. The processing device 100 may already contain the software application 210. In particular, for transferring data between the integrated device 600 and the processing device 100 may be used RFID technology. The interface element 150 of the processing device 100 comprises an RFID antenna, since the processing device 100 acts as a receiver, while the integrated device 600 acts as a transmitter. The integrated device 600 may be scanned by the processing device 100 to transmit data, such as read results of glucose concentration in the blood, to the processing device 100. Meanwhile, the integrated device 600 consumes less energy, and the processing device 100 consumes more energy. The transmitted data, for example, a series of read results of measurements of glucose concentration in the blood, can be provided with time stamps or serial numbers to ensure appropriate storage and analysis of data by the processing device 100.

In other embodiments, the integrated device 600 may transmit data to the remote processing device 100 over the network. As described above, various technologies may be used to provide network communications. For example, an integrated device 600 may be connected to an intermediate device, such as a personal computer having access to the Internet, or a mobile communication device having access to a cellular network, and transmit data remotely to other systems or devices. In other embodiments, integrated device 600 may communicate with a remote system or device more directly. For example, the remote processing device 100 may be a server in a centralized healthcare facility system that provides further processing or storage of data collected by the integrated device 600. A centralized healthcare facility system can provide an external user interface to the software based on a WEB network or client-server technology. an application 210 operating in a remote processing device 200. In other embodiments of the invention or in addition data can be shared with health facilities. Accordingly, to transfer data from the integrated device 600 to the remote processing device 100, the integrated device 600 can be connected directly via an interface element 250, for example, to a wireless network or Wi-Fi access point. To protect data, you can use encryption and authentication procedures. In one embodiment, the integrated device 600 detects the presence of a wireless network or Wi-Fi access point and automatically transfers data to the remote processing device 100 in the background. In other embodiments, an integrated device 600 through a user interface 670 can alert the user to ready access to the remote processing device 100, and the user can initiate data transfer at will.

The integrated device 600 may store the contents of the screen of the user interface 670. For example, the integrated device 600 may have functionalities for recording measurement information and display the logbook in the screen of the user interface 670. The logbook function can be accessed by selecting an icon on the screen or by selecting a function from the menu . However, for convenience, when the user calls up the form on the display screen, the integrated device 600 remembers the contents of the screen, and if the device 600 is turned off, put on standby, or otherwise deactivated while the form is showing, then when the device 600 is activated again, the form display and the contents of the screen appear on the display automatically. Of course, such a storage of the display state can be used for any, also for another function that can be displayed on the display.

In addition, the display state stored by the integrated device 600 can be used by the software application 210, which is executed in the processing device 100. In particular, the user, via the user interface 270 of the integrated device 600, can display some information, for example, a summary of the measurement results. If this particular screen is stored in the display state information, then this display status information can be transmitted to the software application 210 operating in the processing device 100, when connected to the integrated device 600, to automatically launch the functionalities in the software application 210, which correspond to the last screen shown on the display of device 600. Software application 210 may automatically display a screen containing detailed data related to a summary of the measurement results displayed on the display of integrated device 600.

In general, portable device 200 may combine functionalities of various levels, for example, user interface and measurement system functions. However, any device using the components and functions of the portable device 200 may include a user interface, even if it does not contain the components of the meter 500 and does not perform its functions. 7A-10B illustrate additional functions that can be used with the exemplary embodiments described above. Although these functions are described in connection with embodiments using the USB interface element 250, nevertheless, they can be applied to embodiments using the other communication protocols described above for the interface element 250.

7A and 7B illustrate a portable device 700, in many respects similar to the portable device 200 described above. The portable device 700 includes a USB interface element 250A that can protrude from the housing or part of the portable device 700 so that the housing does not interfere with physically inserting the interface element 250A to the USB port of the processing device 100. In particular, a connecting cable 252 of suitable length passes between the interface element 250A and the housing 201 of the portable device 700. The connection cable 252 allows the electrical signals of the interface element 250A to be transmitted to other components of the portable device 700 if the interface element 250A is remote from the housing 201 of the portable device 700. For convenient storage of the excess part of the connection cable 252, the interface element 250A is provided with a camera 251. The camera 251 shown in FIG. .7A contains a spring cable reel with a stopper that pulls any sag of the connecting cable 252 into the chamber 251. The connecting cable 252 provides the appropriate tension If necessary, the additional part of the connecting cable 252 can easily be pulled out of the chamber 251. When the interface element 250A is not used, it can be conveniently stored in the storage cavity 253 in the housing 201 of the portable device 700. Fig. 7B illustrates a portable device 700, connected by cable 252 to a processing device 100B, which is a knee-high personal computer.

8A and 8B illustrate an integrated device 800, in many respects similar to an integrated device 600. The integrated device 800 is equipped with a USB interface element 250. The integrated device 800 can receive power through a USB interface element 250 from a processing device 100, such as a personal computer, or from a battery 260. FIGS. 8A and 8B show that the battery 260 is located in the cap 202 of the interface element 250. Thus, outside the battery 260 is a cover of the interface element 250. The battery 260 may be located inside the cap 202 according to the first orientation, that is, when the cap 202 is placed on the interface element 250, the battery 260 is connected to the interface element volume 250 and supplies power to the integrated device 800. FIG. 8B illustrates a cap 202 in a second orientation in which the battery 260 is displaced so that the battery 260 and the interface element 250 are not aligned. Thus, in the second orientation, the battery 260 is not connected to the interface element 250 to save battery power and extend its life. The cap 202 can be transferred from the first orientation to the second and vice versa by removing the cap 202, rotating the cap 202 180 degrees and installing the cap 202 back onto the interface element 250. The battery 260 may include at least one replaceable battery element. In another embodiment of the invention, non-rechargeable batteries are used that are attached to the cap 202, in which case the entire cap 202 must be replaced to use the new cells.

9A and 9B illustrate another integrated device 900, in many respects similar to the integrated device 800 described above. One end of the integrated device 900 contains a USB interface element 250 with a cap 202. The other end of the integrated device 900 contains the other cap 203, which houses the analytic sensors 400. The caps 202 and 203 are interchangeable. Thus, during operation, the cap 202 is placed on the interface element 250 and connects the battery 260 to supply power, and the cap 203 is removed to provide access to the plates of the sensor 400 for collecting samples. For example, cap 203 may include several analytical sensors 400 that can be used to collect samples, after which analytical sensors 400 can interact with integrated device 800 to collect sample data. However, when the integrated device 800 is not used, the cap 203 can be placed on the interface element 250, and the cap 202 can be placed on the other end of the integrated device 800. The cap 203 can provide appropriate sealing to the ends of the integrated device 800 for proper storage of analytical sensors 400.

10A, another integrated device 1000 is illustrated, in many respects similar to the integrated device 600. The integrated device 1000 comprises a USB interface element 250 in the main body 201. The cap 209 can be disconnectedly connected to the main body 201 and placed on the interface element 250. Cap 209 includes a temperature sensor 280 and a corresponding circuit 281. Sensor 280 may include a thermocouple, thermistor, thermochromatic sensor, and the like. A sensor 280 measures the temperature of the outer surface 204 of or near the cap 209. When the cap 209 is mounted on the interface element 250, the sensor 280 is connected to the interface element 250, and the corresponding temperature data is transmitted to the processor of the integrated device 1000. In general, the temperature of the main body 201 may not correspond to the ambient temperature, since the main body 201 may retain heat. emitted during operation of the integrated device 1000. The temperature of the main body 201 may also depend on closely spaced other warm or cold objects. For example, the body of the patient may be transferred to the main body 201 when the integrated device 1000 is in the hands of the user or is otherwise located near the body of the user. Due to its heat capacity, the main body 201 can achieve thermal equilibrium with the environment for a very long time. Since the outer surface 204 of the cap 209 has weak thermal connection with the main body 201, the temperature measured on or adjacent to the outer surface 204 is essentially independent of the temperature of the main body 201. In addition, the temperature of the sensor 280 reaches equilibrium with the environment much faster than main body 201. A radiator may be used to accelerate the transition of the temperature of the outer surface 204 to ambient temperature. As a result, the sensor 280 more accurately measures the ambient temperature. The temperature data received from the temperature sensor can be used to determine the concentration of the analyte in the sample of physiological fluid (for example, the concentration of glucose in the blood) according to the reaction with the reagent in the measuring sensor 400. Since changes in the temperature of the reagent can affect the reaction level estimates of reagent temperature can be measured ambient temperature. Essentially, the integrated device 1000 can take into account the sensitivity of the reagent to temperature and in this way more accurately calculate the concentration of the analyte in the sample.

FIG. 10B shows a cross-section of a cap 209 with a sensor 280 that can be used with the integrated device 1000 shown in FIG. 10A. In particular, the sensor 280 contains a thin membrane 205 in the part of the outer wall element 206 of the cap 209. The thin membrane 205 is characterized by low heat capacity and a large surface area to thickness ratio, which helps to quickly achieve thermal equilibrium of the thin membrane with the environment. Essentially, a sensor 280 measures the temperature of the thin membrane 205 to achieve a more accurate determination of the ambient temperature. In order to minimize thermal conductivity, the thin membrane 205 may be made of plastic or the like, and the outer wall member 206 may be connected to the rest of the cap 209 so that there is at least one gap 207 between the outer wall member 206 and the rest of the cap 209. The gap 207 directs the flow of ambient air around the thin membrane 205 and in this way accelerates the alignment of the temperature of the thin membrane with the ambient temperature. In another embodiment, the outer wall element 206 may have a very weak locking connection, which has gaps 207 and allows ambient air to flow around the thin membrane 205. The thin membrane 205 or the outer wall element 206 can be replaced for any damage. The temperature sensor circuit 281 may include an infrared (IR) sensor for measuring the temperature of the thin membrane 205. In another embodiment, the thin membrane 205 may be made of thermochromic material that changes color with temperature. In this case, the sensor 280 may include a light source, for example at least one laser LED, and a sensor, for example at least one photodiode. A light source transmits photons to the thermochromic material, and the sensor receives photons reflected from the thermochromic material and indicating the color of the thermochromic material. In some embodiments, the circuit 281 may be located in the main body 201 rather than in the cap 209, while a thin membrane 205 or other design of the temperature sensor remains in the cap 209.

Since the present invention allows various modifications and alternative forms, specific options for its implementation and the proposed methods are described in detail in this document and shown in the accompanying drawings for illustrative purpose and as an example only. However, it should be understood that embodiments of the invention are not limited to its specific forms or methods disclosed, but, on the contrary, are covered by all modifications, equivalents, and alternatives within the spirit and scope of the invention.

Claims (60)

1. A system for managing medical data, comprising:
blood glucose concentration meter, including:
a measuring system configured to determine a glucose concentration measured in a blood sample;
a data storage system including a first memory storing a data management software application and a second memory storing medical data including glucose measurements determined by the measurement system; and
data transfer interface;
a processing device configured to communicate for transmitting data with a blood glucose concentration meter via a data transmission interface; and
a display connected to the processing device with the possibility of data transfer, in which
in response to establishing communication for data transfer between the blood glucose concentration meter and the processing device, the processing device reads the software application for managing data from the first memory and the medical data from the second memory, processes the medical data, executing the data management software application, and displays the processed medical data on a display in which the processing device does not store any components of the data management software application until udet established connection for data transmission between the meter blood glucose concentration and processing device.
2. The system of claim 1, wherein the second memory is provided on at least a USB flash drive or memory card.
3. The system of claim 1, wherein the data storage system is configured according to a memory card indicating security levels for memory areas in a data storage system defining access to data stored in said memory areas.
4. The system according to claim 1, in which the first memory is represented on the EEPROM, and the second memory is presented on the flash memory.
5. The system of claim 1, wherein the blood glucose concentration meter includes a data monitoring system confirming the correctness of the data to be stored in the data storage system.
6. The system according to claim 1, in which the processing device processes the medical data without constant storage in the processing device.
7. The system of claim 1, wherein the processing device deletes any data associated with the data management software application until completion of the data management software application.
8. The system according to claim 1, in which the processing device completes the processing and display of medical data on the display when the data transfer between the specified portable data device and the processing device is completed.
9. The system of claim 1, wherein the processing device is compatible with an interface protocol configuration allowing data transfer between a blood glucose concentration meter and a processing device, and the blood glucose concentration meter is reconfigured to a software application configuration allowing the processing device to read a software application for managing data and medical data from a data storage system, the configuration of the software application being different from the config the radio interface protocol.
10. The system of claim 9, wherein the interface protocol configuration is a configuration of a portable USB mass storage device (MSD).
11. The system according to claim 1, in which the data transfer interface includes at least one of: a universal serial bus (USB) interface, a Secure Digital (SD) interface, and radio frequency (RF) communications.
12. The system according to claim 1, in which the processing device is a personal computer, personal digital assistant or smartphone.
13. The system of claim 1, wherein the data transfer interface also provides data transfer between the blood glucose meter and the printer, and in which (i) the blood glucose meter creates a print-ready medical data file and transmits this ready-to-print file print the file to the printer, or (ii) the printer receives from the data storage system, formats and prints medical data.
14. The system of claim 1, wherein the medical data further comprises temperature data, blood pressure data, heart rate data, respiratory data, or weight data.
15. The system according to claim 1, in which the processing device is one of the processing devices, the type of which is compatible with the data transfer interface.
16. The system of claim 1, wherein the blood glucose concentration meter also comprises a user interface used to display medical data.
17. The system of claim 1, wherein the blood glucose concentration meter also comprises a local processor and a local software application, wherein the local processor processes medical data for display using a user interface.
18. The system according to claim 1, in which the processing device is designated as the base station of the blood glucose concentration meter, which provides additional functions of a data management software application when the blood glucose concentration meter detects its connection to the base station.
19. The system of claim 18, wherein the additional functions include downloading all of the medical data contained in the data storage system to a base station or launching a reference version of a data management software application.
20. The system of claim 1, wherein the security component controls the access of the processing device to medical data in the data storage system.
21. The system of claim 20, wherein the security component requests authentication information from the user and verifies that the authentication information is correct when the processing device attempts to access medical data.
22. The system according to claim 20, in which the protection component establishes a protected system with the requirement of registering the processing device in a blood glucose concentration meter.
23. The system of claim 22, wherein the processing device requires registration of a blood glucose concentration meter and the installation of two-way authentication.
24. The system of claim 20, wherein the security component encrypts medical data in a system for storing data during transmission to a processing device.
25. The system of claim 20, wherein the security component restricts the access of the data management software application to medical data.
26. The system of claim 20, wherein the security component restricts access to medical data in the data storage system in accordance with the data type.
27. The system according to claim 20, in which the medical data is encrypted, and the software application for data management must decrypt them.
28. A system for managing medical data, comprising:
blood glucose concentration meter, including:
a measuring system configured to determine a glucose concentration measured in a blood sample;
a data storage system including a first memory storing a data management software application and a second memory storing medical data including glucose measurements determined by the measurement system;
a processing device configured to connect to a blood glucose concentration meter; and
a display connected to the processing device with the possibility of data transfer, in which
the blood glucose concentration meter has a first software configuration corresponding to the interface protocol and a second software configuration adapted for the data management software application, wherein the second software configuration permits the data management software application to be executed from the data storage system; wherein
after connecting the blood glucose meter and the processing device, the processing device communicates with the blood glucose meter according to the interface protocol, and after reconfiguring the blood glucose meter from the first configuration to the second configuration, the processing device reads the software for managing data from the first memory and medical data from a second memory, processes medical data, executing a data management software application, and displays the processed medical data on a display, and in which the processing device does not store any components of the data management software application until a connection is established between the blood glucose concentration meter and the processing device.
29. The system of claim 28, wherein the data storage system comprises an initialization program that, after connecting the blood glucose meter to the processing device, executes and reconfigures the blood glucose meter from the first configuration to the second configuration.
30. The system of claim 28, wherein the interface protocol corresponds to a universal serial bus (USB), and the first configuration is a configuration of a portable large memory USB device (MSD).
31. The system of claim 28, wherein the blood glucose concentration meter and the processing device are connected via a universal serial bus (USB) interface, a Secure Digital interface, or a radio frequency (RF) communication device.
32. The system of claim 28, wherein the processing device is a personal computer, personal digital assistant, or smartphone.
33. The system of claim 28, wherein the processing device processes the medical data without permanently storing the data in the processing device.
34. The system of claim 28, wherein the processing device deletes any data in the processing device associated with the data management software application until completion of the data management software application.
35. The system of claim 28, wherein the data management software application ends when data transfer between the blood glucose concentration meter and the processing device is completed.
36. A method of managing medical data, according to which:
establish, for the first time, a connection for transmitting data between a blood glucose concentration meter in a processing device via a data transmission interface, wherein the blood glucose concentration meter includes:
a measuring system configured to determine a glucose concentration measured in a blood sample;
a data storage system including a first memory storing a data management software application and a second memory storing medical data including glucose measurements determined by the measurement system; and
data transfer interface
in which the processing device does not store any components of the data management software application until a connection is established for data transfer between the blood glucose concentration meter and the processing device,
reading, using a processing device, a software application for managing data from the first memory and medical data from the second memory;
process, using a processing device, medical data by executing a data management software application, and
using the processing device, the processed medical data is displayed on a display connected to the processing device.
37. The method according to clause 36, according to which the processing of medical data in a processing device includes processing medical data without permanent storage of data in the processing device.
38. The method according to clause 36, whereby any data associated with the data management software application is also deleted in the processing device until the medical data processing step is completed.
39. The method according to clause 36, according to which the medical data processing step is also completed when the data transfer between the blood glucose concentration meter and the processing device is completed.
40. The method according to clause 36, according to which the processing device is compatible with the configuration of the interface protocol that allows communication between the blood glucose meter and the processing device, and the method further comprises reconfiguring the blood glucose meter in the configuration of the software application, adapted for a data management software application, wherein the software application configuration is different from the interface protocol configuration sa
41. The method of claim 40, wherein the interface protocol configuration is a configuration of a portable USB mass storage device (MSD).
42. The method according to clause 36, according to which the data transfer interface comprises at least one of: universal serial bus (USB) interface, Secure Digital (SD) interface and radio frequency (RF) communication means.
43. The method according to clause 36, according to which the processing device is a personal computer, personal digital assistant or smartphone.
44. The method according to clause 36, according to which the access of the processing device to the medical data in the data storage system is also controlled.
45. The method according to item 44, according to which, when controlling access, they request identification information from the user and verify its authenticity when the processing device tries to gain access to medical data.
46. The method according to item 44, whereby when controlling access, a secure system is installed by requiring the processing device to be registered in a blood glucose concentration meter.
47. The method according to item 44, whereby when controlling access require registration of a glucose concentration meter in the blood and the installation of two-way authentication.
48. The method according to item 44, whereby when managing access, medical data is encrypted in a data storage system.
49. The method according to item 44, according to which when controlling access limit the access of the software application for managing data to medical data.
50. The method according to item 44, whereby when controlling access restricts access to medical data in the system for storing data in accordance with the type of data.
51. The method according to item 44, according to which the medical data is also encrypted and when access control requires decryption of the data by the data management software application.
52. A method of managing medical data, according to which:
detecting a connection between a blood glucose concentration meter and a processing device, wherein the blood glucose concentration meter includes:
a measuring system configured to determine a glucose concentration measured in a blood sample;
a data storage system including a first memory storing a data management software application and a second memory storing medical data including glucose measurements determined by a measurement system in which
the blood glucose concentration meter has a first software configuration corresponding to the interface protocol and a second software configuration adapted for the data management software application, wherein the second software configuration permits the data management software application to be executed from the data storage system;
reconfiguring a blood glucose concentration meter from a first configuration to a second configuration adapted for a software application;
reading, using a processing device, a software application for managing data from the first memory and medical data from the second memory;
process, using a processing device, medical data by executing a data management software application, and
using the processing device, the processed medical data is displayed on a display in which the processing device does not store any components of the data management software application until a connection is established between the blood glucose concentration meter and the processing device.
53. The method according to clause 37, according to which, after determining the connection, they also run the initialization program stored in the data storage system, the blood glucose concentration meter being reconfigured by the initialization program.
54. The method according to clause 37, according to which the interface protocol corresponds to one of: universal serial bus (USB) interface, Secure Digital interface and radio frequency (RF) communication tool.
55. A device for managing medical data, comprising:
the first part of the housing containing the medical data management system and the data transfer element, providing communication for data transfer between the medical data management system and the external processing device, the medical data management system includes a meter designed to measure the concentration of the analyte in the user’s sample; and
the second part of the housing connected with the possibility of disconnection with the first part of the housing, while the second part of the housing includes a temperature sensor that provides an ambient temperature measurement for the medical data management system, using the results of the ambient temperature measurement to determine the concentration of the analyte.
56. The device according to item 55, in which the second part of the housing is a cap for the data transmission element of the first part of the housing, and the temperature sensor measures the ambient temperature on or near the surface of the cap, in which
the cap is located on top of the data transmission element of the first part of the housing, while the temperature sensor of the second part of the housing is connected to the data transmission element and transmits the temperature data to the medical data management system via the data transmission element.
57. The device according to p, in which the data transfer element is a USB connector, and the cap covers the USB connector.
58. The device according to p, in which at least one component contains a temperature sensor that provides an ambient temperature measurement for the medical data management system, using the results of measuring the ambient temperature to determine the results of the medical data measurement system.
59. The device according to § 58, in which the temperature sensor measures the ambient temperature on the outer surface of the second part of the housing.
60. The device according to § 59, in which the temperature sensor measures the ambient temperature of the thin membrane on the outer surface of the second part of the housing.
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US61/012,718 2007-12-10
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