US 20080300919 A1
An architecture allows individual system components to be developed and tested individually, i.e., as distinct modules, and to be subsequently combined through standardized electrical and communication interfaces. Any combination of these modules can be implemented to form different products that provide any number of functions, such as an integrated system for monitoring a health condition and/or delivering a medication. The architecture also provides an approach for dynamically updating the product and offering its users the latest generation of technology even after the users have already purchased the product. In particular, the embodiments employ the communication interfaces to also provide connection to a remote network that can update or upgrade the product's software when the product is out in the field.
1. A system for managing healthcare data, comprising:
a first set of at least one module providing primary healthcare functions;
a first central engine controlling the first set of at least one module;
a second set of at least one module providing secondary healthcare functions;
a second central engine controlling the second set of at least one module; and
a communication interface providing a connection between the first central engine and the second central engine.
2. The system of
3. The system of
4. The system of
5. The system of
6. The system of
7. A method for managing healthcare data, comprising:
developing, according to a first development process, a first assembly of a first central engine and a first set of at least one module providing primary healthcare functions, the first central engine controlling the first set of at least one module;
developing, according to a second development process, a second assembly of a second central engine and a second set of at least one module secondary healthcare functions; and
connecting the first assembly and the second assembly via a communication interface.
This application claims priority to U.S. Provisional Application No. 60/932,286, filed May 30, 2007, U.S. Provisional Application No. 61/012,721, filed Dec. 10, 2007, and U.S. Provisional No. 61/012,718, filed Dec. 10, 2007, the contents of which are incorporated entirely herein by reference.
The present invention relates generally to a method and system for developing healthcare devices. More specifically, the method and system of the present invention provides an architecture that allows any combination of modules with different functions to be easily assembled to form an integrated system for monitoring a health condition and/or delivering a medication. In addition, the method and system provides an architecture that allows the modules to be updated dynamically during operation in the field.
The quantitative determination of analytes in body fluids is of great importance in the diagnoses and maintenance of certain physiological conditions. For example, individuals with diabetes frequently check the glucose level in their bodily fluids. The results of such tests can be used to regulate the glucose intake in their diets and/or to determine whether insulin or other medication needs to be administered.
Diagnostic systems, such as blood-glucose systems, may employ a meter or instrument to calculate the glucose value in a blood sample from an individual. Such instruments operate by measuring an output, such as current or color, from a reaction with the glucose in the sample. The test results typically are displayed and stored by the meter. Basic systems allow the user to access the test results directly from the meter via a keypad or other interactive component.
Other diagnostic systems, however, provide more advanced functionality to allow a user to process and manage test results. For example, some systems allow a user to load test results from a blood-glucose meter onto a processing device, such as a conventional desktop personal computer (PC), and to process and display the results with a data-management application. However, using the processing power of PC technology to organize results from a blood-glucose meter is just one example of how diagnostic systems provide more functionality by incorporating different technologies into a diagnostic process.
Although integrating different technologies and functions may yield highly sophisticated and extremely useful diagnostic systems, the introduction of such systems into the marketplace is slowed by current approaches to product design and development in the industry. For example, current approaches to the design of multi-function products employ complicated system architectures that interconnect the variety of functional elements via distinct and non-standard techniques. Accordingly, a functional element must be developed with the specific final product and the other functional elements in mind. In other words, the complex architecture results in dependencies between functional elements, and thus does not allow each element to be developed independently and/or in parallel. As such, the development process requires more time as more components are added and complexity is increased.
In addition, although the final integrated product may provide the features and advantages of a variety of technologies, the rapid pace of change in these technologies may outdate the final product before the final product is introduced to the market, particularly because product development takes such a long time. In other words, current approaches to product development make it difficult to ensure that the users of the product have the latest generation of technology. Where the cost of integrated products may be relatively high due to the greater amount of functionality, consumers may find less justification in purchasing such products when their technology may become quickly outdated.
In view of the foregoing, there is a need for design and development approaches that simplify the process of combining different technological components into a single product while meeting the high quality standards for medical devices. In particular, there is a need for an approach that simplifies interfaces between components and therefore permits different combinations of components to be easily and reliably integrated regardless of the number of components. Moreover, there is a need for an approach that allows the final product to be dynamically and continuously updated to offer its users the most current technology.
The embodiments described herein address the needs identified above by providing an architecture that allows individual system components to be developed and tested individually, i.e., as distinct modules, and to be subsequently combined through standardized electrical and communication interfaces. Any combination of these modules can be implemented to form different products that provide any number of functions, such as an integrated system for monitoring a health condition and/or delivering a medication.
Although the architecture makes it more feasible to shorten a product's development cycle and to introduce the product to consumers more quickly, the embodiments also provide an approach for dynamically updating the product and offering its users the latest generation of technology even after the users have already purchased the product. In particular, the embodiments employ the communication interfaces to also provide connection to a remote network that can update or upgrade the product's software when the product is out in the field. This process is known as a field upgrade.
Because the interfaces and communication protocols are designed to facilitate connection between different components and the rest of the system, the embodiments also provide functionality that ensures that unauthorized individuals or devices cannot connect with the system and compromise the security of data, such as personal medical information, which may be collected, stored, and handled by the system. With this underlying security functionality, particular technologies, such as wireless communication, can be implemented as components of medical diagnostic systems without concern over unauthorized access to personal information.
In addition, due to the important medical functions associated with the assembled product, embodiments employ validation procedures to ensure that any data transferred to the product, for example, during field upgrade, does not corrupt the data or the software stored by the product and that the product continues to operate as expected.
Still other aspects, features, and advantages of the present invention are readily apparent from the following detailed description, by illustrating a number of exemplary embodiments and implementations, including the best mode contemplated for carrying out the present invention. The present invention is also capable of other and different embodiments, and its several details can be modified in various respects, all without departing from the spirit and scope of the present invention. Accordingly, the drawings and descriptions are to be regarded as illustrative in nature, and not as restrictive. The invention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the invention.
The embodiments described herein provide a system architecture that allows individual system components, or modules, to be developed and validated independently (as distinct modules) and subsequently combined through standardized electrical and communication interfaces. The standardized interfaces facilitate the combination and configuration of these modules to form different products that provide any number of functions. While the architecture can be used to form a fixed combination of components, the approach also permits reconfigurable or expandable combinations where different components may be easily removed or added to the system. In addition, as described further below, the architecture provides an approach for dynamically updating the modules after they have been integrated into the product.
Although the modules 30A, 30B, 30C, and 30D of
In one embodiment, the central engine 10 is implemented on a mother board, while each module is separately implemented on a daughter board. The daughter boards are standardized so that they may connect to a single mother board to be integrated with the system. In other words, specific interfaces with boards corresponding to other modules do not have to be developed each time a new module is implemented. Due to this standardized approach, using commercial off-the-shelf (COTS) hardware for the mother and daughter boards becomes more feasible. Advantageously, using COTS hardware requires less development time than an application-specific integrated circuit (ASIC) approach.
In some embodiments, the mother board and the daughter boards may physically reside on separate circuit boards. In other embodiments, the mother board and the daughter boards may all be physically integrated onto the same circuit board. In further embodiments, the mother board and a combination of daughter boards may be physically integrated onto the same circuit board, while other daughter boards reside on separate circuit boards. Moreover, in some embodiments, the mother board and the daughter boards, whether on the same circuit boards or not, may all be disposed in the same housing, or casing. Meanwhile, in other embodiments, some or all of the daughter boards may be disposed in one or more housings separate from the mother board's housing. In general, the components of embodiments may be subject to varying degrees of physical integration regarding assembly on different circuit boards or within different housings, etc. To accommodate this variation in physical configuration, more than one interface type may be required to connect the daughter boards to the mother board, but as discussed previously, the interfaces between the central engine and the modules do not have to follow the same communications protocol. The interface elements associated with the mother board can employ the most widely-used standard protocols so that the central engine is more likely to be compatible with a given module.
The centralized architecture using standardized interfaces facilitates the development of compatible modules. When adding functionality to the system, integration with the architecture is easily achieved by employing a compatible interface element. Moreover, the new module can be developed independently of the other modules, because only a single interface with the central engine 10 is required. In other words, even if the new module must communicate with other modules in the system, the new module does not have to be designed for a direct connection with the other modules, so the communications configuration of the other modules is not a significant design consideration for the new module. Accordingly, the ability to independently develop additional modules that easily connect with the central engine 10 enables systems employing this architecture to be flexible and reconfigurable. For example, such a system can be expanded with new modules or upgraded with new versions of existing modules.
In the embodiment of
Although an advantage of the architectures described herein is the ease by which new modules can interface with the system and establish communications and data exchange, issues relating to the security of personal medical data have discouraged using highly compatible communication technologies with medical devices, such as personal testing devices that measure and store health data. To address these issues, embodiments according to aspects of the present invention provide functionality that helps to ensure that unauthorized individuals or devices cannot connect with the system and compromise the security of any personal medical information. The central engine 10 may be responsible for providing security measures. Alternatively or additionally, a component or module with special security functions may be employed to promote system security. With such security functionality, particular technologies, such as wireless communication, can be implemented as components of medical diagnostic systems without heightened concern over unauthorized access to personal information.
As shown in
In the embodiments of
Data security may also be enhanced by using encrypted data during communications, as shown in
Data security may be further enhanced by ensuring that all data is stored by the central engine 10 within memory in the architecture and is not transferred to any connected modules. Thus, a user may, for example, use a public computer to interface with the system and no data will be transferred to the public computer for others to access.
As shown in
In addition, the computing device 370 executes the software 375 to receive data from the modules 310, 320, and 330 and provides advanced data processing and management capabilities. The computing device 370 may be selected from a variety of processing devices, such as desktop or laptop personal computers (PCs), handheld or pocket personal computers (HPCs), compatible personal digital assistants (PDAs), and smart cellular phones. The processing devices may employ a variety of operating systems and configurations. For example, if the computing device 370 is a desktop or laptop personal computer, the operating system may be a version of Microsoft® Windows®. Alternatively, if the computing device 370 is a PDA, the operating system may correspond with those of PALM® handhelds from Palm, Inc., or Blackberry® devices from Research in Motion Limited. In general, computing device 370 includes a processor that is capable of receiving and executing any number of programmed instructions.
The data-management software 375 on the computing device 370 may be a collection of programs or computer code that receives and processes data measured by the modules 310 and 320, for example. The software 375 processes and/or displays this input in a manner that is desired by the user. This information may be used by, for example, a user, home care provider (HCP), and/or a physician. The measured data from the modules 310 and 320 may include, for example, the concentration of glucose and/or other analytes in a person's blood or other bodily fluid. Advantageously, the software 375 can provide the advanced displays and data processing that may be required by a user who tests multiple times a day (e.g., about six to about ten times a day). For example, the software 375 may include a product similar to WINGLUCOFACTS® Diabetes Management Software available from Bayer HealthCare LLC (Tarrytown, N.Y.). As such, the software 375 may provide a complete tool kit that receives and stores test results from a blood-glucose measurement system, receives and stores other testing information such as test times and meal markers, tracks test results in an electronic logbook, calculates averages and provides statistical analysis of outlier test results, summarizes and provides feedback on the test results, provides a customizable graphical user interface, displays user-friendly charts and graphs of the test results, tracks test results against user-specific target ranges, provides predictive analysis, and/or sends data to healthcare professionals via fax, email, etc. As described previously, data security is enhanced if the software 375 does not upload data from the modules 310 and 320 to the computing device 370 and the data is always stored within a single central storage device.
As described further below, the use of software or programmed instructions is not limited to the computing device 370. Moreover, the use of embodiments of the present invention are not using the particular modules 310, 320, 330, and 370.
As shown in
Referring again to
Power management element 120 distributes power from a power supply to the processor 112 as well as modules 300 that do not have their own power source. The power management system 114, for example, may be configured to enter a standby mode to minimize power use when the system is idle. Additionally, if a rechargeable battery is employed, the power management system 114 may also handle the recharging of the battery.
As also shown in
Referring again to
The test sensor 316 includes a fluid-receiving area for receiving a sample of body fluid. For example, a user may employ a lancet or a lancing device to pierce a finger or other area of the body to produce the blood sample at the skin surface. The user may then collect this blood sample by placing the test sensor 316 into contact with the sample. The fluid-receiving area may contain a reagent which reacts with the sample to indicate the concentration of an analyte in the sample.
The test sensor 316 may be an electrochemical test sensor. An electrochemical test sensor typically includes a plurality of electrodes and a fluid-receiving area that contains an enzyme. The fluid-receiving area includes a reagent for converting an analyte of interest (e.g., glucose) in a fluid sample (e.g., blood) into a chemical species that is electrochemically measurable, in terms of the electrical current it produces, by the components of the electrode pattern. The reagent typically contains an enzyme such as, for example, glucose oxidase, which reacts with the analyte and with an electron acceptor such as a ferricyanide salt to produce an electrochemically measurable species that can be detected by the electrodes. It is contemplated that other enzymes may be used to react with glucose such as glucose dehydrogenase. In general, the enzyme is selected to react with the desired analyte or analytes to be tested so as to assist in determining an information related to an analyte (e.g. analyte concentration) of a fluid sample. If the concentration of another analyte is to be determined, an appropriate enzyme is selected to react with the analyte.
Alternatively, the test sensor 316 may be an optical test sensor. Optical test sensor systems may use techniques such as, for example, transmission spectroscopy, diffuse reflectance, or fluorescence spectroscopy for measuring the analyte concentration. An indicator reagent system and an analyte in a sample of body fluid are reacted to produce a chromatic reaction, as the reaction between the reagent and analyte causes the sample to change color. The degree of color change is indicative of the analyte concentration in the body fluid. The color change of the sample is evaluated to measure the absorbance level of the transmitted light.
Some commercially available test sensors that may be used by the embodiments described herein include those that are available commercially from Bayer HealthCare LLC (Tarrytown, N.Y.). These test sensors include, but are not limited to, those used in the Ascensia® CONTOUR® blood glucose monitoring system, the Ascensia® BREEZE® and BREEZE®2 blood glucose monitoring system, and the Ascensia® Elite® and Elite® XL blood glucose monitoring system. It is contemplated that other test sensors, in addition to the ones listed above, may be incorporated into the methods and systems of the present invention.
As illustrated in
Although the BGM 310 can store test results and provide a user interface 315 to display test results, the data-management software 375 on the computing device 400 provides more advanced functionality for managing, processing, and displaying test results and related information. Therefore, the test-related data collected by the BGM 310 can be communicated via the central engine 110 to the computing device 370 for use with the data-management software 375. As shown in
As discussed previously, the central engine 110 has the power management 114 which may include a power supply that is rechargeable via the connection with the computing device 370 or some other power source. When the central engine 110 and the BGM 310 are connected, a rechargeable battery can be recharged via power management 314.
As described previously, the BGM 310 in
As shown in
It is understood that other techniques may be employed to communicate a signal from the sensor-receiving module 380. For example, a test sensor 316 may be an optical test sensor and the sensor-receiving system 380 may include an optical detector to detect a chromatic reaction. If the sensor-receiving module 380 requires any power to receive or process a signal from the test sensor 316, the power can be drawn through its connection with the central engine 110.
Alternatively, in another embodiment, the computing device 370 is not employed in the system, so that the sensor-receiving module 380 is only connected to the central engine 110 as shown in
The measurement software 253 for controlling the test process and determining the results may be available through the storage device 250 as illustrated in
The storage device 250 may be assembled with the central engine 110 in the housing 101, as shown in
As a further example, the storage device 250 may be a Secure Digital (SD) memory card with a series of contacts that act as the interface element, and the communication interface 210 may be an expansion slot that receives the contacts of the memory card. In this example, the central engine 110 and the storage device 200 may comply with SDIO (Secure Digital Input Output) interface specifications. It is contemplated that other memory card formats having different interface specifications may be employed. However, having an SDIO is advantageous because many hosts such as PDAs, HPCs and smart cellular phones include an expansion slot that is SDIO compatible.
As the central engine 110 in
Because embodiments may employ many different types of modules 300 that may be situated on different types of hardware, the communication interfaces 210 generally have to accommodate more than one type of communication technology, or protocol. However, to minimize the number of communication interfaces 210 while providing the widest range of compatibility between the central engine 110 and the various modules 300, the communication interfaces 210 can employ widely-used and standardized interface technologies, such as USB or Bluetooth® technology. Preferably, the communication interfaces 210 employ technologies that minimize the amount of configuration required to establish communication between a module 300 and the central engine 110. Indeed, some communication technologies, such as USB connectivity, provide plug-n-play (PnP) capability. In these embodiments, the module 300 is physically connected, for example, through a conventional USB port. Then in response, the central engine 110 immediately recognizes the module 300 and establishes immediate communication with the module 300,
The communication interfaces 210 not only provide communication between modules 300, but they also enable secure communication with external networks. As such, embodiments may employ a connection to an external network to download updates, upgrades, or additions to the software in the central engine and/or the modules 300 when the product is out in the field. In other words, the embodiments may provide field upgradeable software functions. Advantageously, embodiments allow the user to update any software/firmware in the integrated system, e.g., software for the central engine 110 and/or the modules 300, by using program files provided by, or purchased from, the manufacturer or an authorized third party. Existing system software can be updated or patched with newer versions, or new software may be added to the system, without requiring the user to contact the manufacturer or third party for direct assistance. The new software allows the user to customize and/or expand the functionality of the system. In some cases, a product may be essentially converted to a new product. Field upgrades make the latest product features available to users who have already purchased a product. Moreover, field upgrades making existing product compatible with other newly released accessories or devices. For example, in a diabetes-management system, if the BGM 310 uses a test sensor to test blood for blood glucose concentration, and the BGM manufacturer develops a new test sensor that improves accuracy or test time, embodiments would allow the user to upgrade the firmware in the device so that the BGM 310 is capable of reading the new test sensor.
The central engine may manage aspects of the field upgrade validation in combination with a download engine. The download engine, described further below, can receive system components from a server, e.g., the field upgrade server, the external network via a communication interface and deliver the system components for validation and deployment. Additionally or alternatively, the server on the external network can manage aspects of the field upgrade process.
In addition, due to the important medical functions associated with the modules 300, embodiments employ validation procedures before employing the new software or configuration information to ensure that any field upgrade does not corrupt the data or the software stored by the product and that the product continues to operate as expected. For example, check-sum routines may be employed to confirm that data or software has been successfully downloaded in its entirety. For example, the central engine 110 may validate downloads according to an associated data update file (DUF) or other component that ensures that the software has been successfully downloaded. For additional data security, the field upgrade process may employ data encryption/decryption.
In an example embodiment illustrated in
An example embodiment is described with reference to
For example, the user interface may communicate in many languages, but all the data required for those languages does not have to be stored locally, as users may download language files as required to customize the operation of their systems. In addition, users can customize the appearance of the user interface display by installing custom pictures to display on the screen or by downloading display layouts made available by a manufacturer or an authorized third party. Furthermore, users can customize the behavior of the system by installing standalone applications (such as games) that can run on the system processor and be played when the system 400 is not being used to analyze body fluids. Users can also customize system behavior by installing software that changes the way body fluid analysis results are displayed, as results may be presented as digital readouts, simulated analog gauges, qualitative feedback, etc.
Referring again to
In addition, the input/output interfaces 200 may allow information to be communicated to and from the user via audio signals. For example, the input/output interfaces 200 may include a speech synthesizer, MP3 playback, or the like, for communicating audio information to a user. Additionally, the input/output interfaces 200 may also include a speech recognition mechanism to receive audio information from a user.
Furthermore, the user interfaces 200 may allow the user to input information or instructions into the system. For example, the user may be required to respond to simple prompts or make menu selections to guide one of the modules 300 during operation. Or as a further example, the user may want to enter instructions to retrieve information, such as test results, and to present the information on the display interfaces 220. Mechanisms for providing input, for example, may include a keypad, a touch screen, a thumb wheel, or the like.
As shown in
Systems employing the architecture support various types of electronic networks and communications. Modules 300 may be employed, for example, to provide cellular activity. Other embodiments, alternatively or additionally, may employ global positioning system (GPS) technology, which has become widely accessible to civilian applications such as road navigation, people tracking, and timing services. With the technology becoming more and more mature, the cost of integrating this technology into consumer products and medical device has been significantly reduced. GPS receiver chipsets are currently available on market and can be easily integrated with consumer or medical device to provide information on device location, velocity and Universal time. As such, GPS may be provided to enhance the functionality of a system employing architecture to form an integrated system for monitoring a health condition and/or delivering a medication.
With GPS, a diabetes-management system, for example, can provide additional information associated with glucose tests. Accurate timestamps and locations can be associated with readings. The erroneous timestamps generated by conventional meters have been the source of confusion and difficulty when readings from multiple meters are downloaded and merged into one database file, or uploaded to computers or web servers that do not have their local time in sync with the meters. Patient movement and exercise can be tracked automatically, facilitating patient logging effort tremendously. The data may include distance and speed. This information can be used for patient daily activity planning for exercise, diet, medication and blood glucose test frequency, etc. It also enables comprehensive analysis of correlation between reading patterns and daily activities Furthermore, patients can be located in emergencies.
The additional timing, location and physical activity information obtained with GPS, combined with logged diet, medication information, can assist the diabetes-management system to make more accurate predictions on patients' daily blood glucose patterns. The diabetes-management system can make real-time daily activity recommendations that will help them to control their blood glucose levels in the prescribed range. The system can then remind patients to take the right number of tests daily at the right moments.
Accordingly, GPS may be employed to synchronize a system's device's real time clock (RTC) to UMT with high precision so that glucose readings can be associated with correct timestamp. As power for the GPS functionality may be a consideration, the GPS receiver may only need to be activated once a day or a week depending on the device crystal quality. Assuming that each time the GPS consumes 0.175 mAhr power (calculated based on Xemics XE1600 receiver using Trimble chipsets), and the device takes a GPS measurement once a day, 63.9 mAhr is consumed in a year for the GPS related calculation which is roughly about 10-20% of a regular cell phone battery capacity.
As discussed previously, some portable embodiments of an integrated monitoring/delivery system may connect with a computing device 370 for advanced data management. This situation provides the opportunity for applying the NAVSYS GPS recorder model (TrackTag) to the portable device to track patient movement and activity. Because a GPS recorder simply takes snapshots of satellite signals without processing them, a significant amount of power can be saved. Assume the device takes a GPS snapshot once every 150 sec, then in one year this GPS recorder only consumes about 280 mAhr, which is roughly about <50% of a regular cell phone battery capacity. If the device can stop taking snapshots at night then further energy can be preserved. The trade off in using the TrackTag approach is the required amount of on-device memory required. Every snapshot takes about 15 kbyte, so at the above snapshot rate, there will be about 200,000 snapshot per year which requires about 3 Gbyte memory. Of course, once GPS data is downloaded from the device to computer and processed, the device memory can be freed up and reused. It seems that one Gbyte memory may support 4 months of location tracking for the portable device. Using modern flash memory technology, one Gbyte device memory can be easily accommodated.
The GPS functionality may be a built-in central function. In a more modular example, however, the GPS functionality may be provided by a connected module, i.e. a detachable GPS receiver. Indeed, if the GPS receiver module has its own memory to store time and position information, then the GPS may not need to be connected all the time with the DM device. The GPS receiver may be connected with the system once a day or one every few days depending on how often the device clock needs to be synchronized and also on the availability of GPS receiver memory. Advantageously, the use of a detachable GPS receiver module minimized the impact on hardware/software design of the central engine 110 and other aspects of the system. Moreover, power management is facilitated.
While the invention is susceptible to various modifications and alternative forms, specific embodiments and methods thereof have been shown by way of example in the drawings and are described in detail herein. It should be understood, however, that it is not intended to limit the invention to the particular forms or methods disclosed, but, to the contrary, the intention is to cover all modifications, equivalents and alternatives falling within the spirit and scope of the invention.