US20080300919A1 - Architecture for health monitoring systems - Google Patents

Abstract

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.

Description

CROSS REFERENCE TO RELATED APPLICATIONS
• 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.
FIELD OF THE INVENTION
• 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.
BACKGROUND OF THE INVENTION
• 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.
SUMMARY OF THE INVENTION
• 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.
BRIEF DESCRIPTION OF THE DRAWINGS
• FIG. 1A illustrates a diagram of an architecture according to aspects of the present invention.
• FIG. 1B illustrates a diagram of another architecture according to aspects of the present invention.
• FIG. 2A illustrates an example security measure that can be employed by an architecture according to aspects of the present invention.
• FIG. 2B illustrates another example security measure that can be employed by an architecture according to aspects of the present invention.
• FIG. 2C illustrates a further example security measure that can be employed by an architecture according to aspects of the present invention.
• FIG. 2D illustrates yet another example security measure that can be employed by an architecture according to aspects of the present invention.
• FIG. 3 illustrates an example diabetes-management system employing an architecture according to aspects of the present invention.
• FIG. 4 illustrates another diagram of an architecture according to aspects of the present invention.
• FIG. 5 illustrates an example of a diagnostic system employing an architecture according to aspects of the present invention.
• FIG. 6 illustrates another example of a diagnostic system employing an architecture according to aspects of the present invention.
• FIG. 7 illustrates yet another example of a diagnostic system employing an architecture according to aspects of the present invention.
• FIG. 8 illustrates a field-upgradeable architecture according to aspects of the present invention.
• FIG. 9 illustrates an example for employing a field upgrade according to aspects of the present invention.
DESCRIPTION OF ILLUSTRATED EMBODIMENTS
• 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.
• FIG. 1A illustrates a conceptual diagram of a modular architecture according to aspects of the present invention. As shown inFIG. 1A, amodular architecture system1 includescentral engine10 that is connected to a plurality ofmodules30A,30B,30C, and30D, each of which provides a functionality for a health monitoring and delivery system. Thecentral engine10 enables themodules30A,30B,30C, and30D to work as an effective system. For example, thecentral engine10 allows information to be communicated between themodules30A,30B,30C, and30D. For example,module30D may be a computing device with software that processes data received from theother modules30A,30B, and30C via thecentral engine10. AsFIG. 1A further illustrates,interface elements22A,22B,22C, and22D of thecentral engine10 connect withrespective interface elements24A,24B,24C, and24D to establish communications between thecentral engine10 and themodules30A,30B,30C, and30D. The interfaces may provide wired, i.e. physical, and/or wireless communications. Advantageously, the centralized organization of the interface architecture facilitates the integration ofmodules30A,30B,30C, and30D, which can be developed and tested separately from each other. Moreover, although theinterface elements22A,22B,22C, and22D of thecentral engine10 do not have to follow the same communications protocol, theinterface elements22A,22B,22C, and22D can employ the most widely-used standard protocols so that thecentral engine10 is more likely to be compatible with a given module.
• Although themodules30A,30B,30C, and30D ofFIG. 1A may all communicate information with each other, it is contemplated that a module connected to thecentral engine10 does not have to communicate with all of the other modules. Indeed, a module may be communicatively isolated from any, including all, of the other modules. For example, the nature of data and/or software on a particular module may be highly sensitive, so the module may be isolated from the other modules to enhance the security and/or integrity of the data.
• In one embodiment, thecentral engine10 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 thecentral engine10 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 thecentral engine10 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.
• AlthoughFIG. 1A illustrates an embodiment with the singlecentral engine10 connected tomodules30A,30B,30C, and30D, thecentral engine10 in some embodiments may also connect to a secondarycentral engine40 as illustrated inFIG. 1B. As shown inFIG. 1B, thecentral engine10 is connected tomodules30A,30B, and30C via correspondinginterface elements22A/24A,22B/24B, and22C/24C. Meanwhile, thecentral engine40 is connected tomodules60A,60B, and60C via correspondinginterface elements52A/54A,52B/54B, and52C/54C. As with themodules30A,30B, and30C, themodules60A,60B, and60C may be developed independently of the other modules according to a modular architecture that only requires a single interface with thecentral engine40. As further illustrated inFIG. 1B, thecentral engine10 may be connected to thecentral engine40 viainterface elements22D and52D. Like the other interface elements, theinterface elements22D and52D may provide wired, i.e. physical, or wireless communications. In some embodiments, thecentral engine10 assumes a host function for thecentral engine40. For example, if thecentral engine10 connects to thecentral engine40 according to universal serial bus (USB) communication protocol, standard USB requires a host-slave relationship between the two systems.
• In the embodiment ofFIG. 1B, thecentral engine10 may access the functionalities provided by themodules60A,60B, and60C, and conversely, thecentral engine40 may access the functionalities provided by themodules30A,30B, and30C. Even though the resulting combination may function like a single central engine connected to all sixmodules30A,30B,30C,60A,60B, and60C, thecentral engines10 and40 may be developed separately. As such, the development of a set of modules can be advantageously organized into separate subsets. For example, medical diagnostic systems may include critical medical devices, such as a blood-glucose meter, as well as other types of devices, such as a heart rate monitor. The critical medical devices may require very rigorous product validation during development and may be subject to government regulations. Meanwhile, the other types of devices may not require the same type or same level of validation. As such, modules involving critical medical devices may have very different timelines and guidelines for product development compared to the other types of health care devices. Thus, in this case, it may be advantageous to organize the modules into two product development groups. In addition, every time a product involving critical medical devices is redeveloped or updated to include new features, government regulations may require revalidation of the product even if the new features may be relatively minor. For example, if a heart rate monitor is added to a central engine that is already connected to a blood-glucose meter, the entire system may have to be revalidated at great cost and effort, even though the new modules is a less critical health care device. However, the central engine connected to the blood-glucose meter can remain unchanged if the central engine already has the capability to connect to a secondary central engine that in turn is connected to the heart rate monitor. In other words, deploying new modules involving other health care devices and other features through the secondary central engine provides a way to expand the overall product without changing the architecture associated with the primary central engine. Moreover, any validation of the architecture associated with the secondary central engine may be conducted without affecting the architecture associated with the primary central engine.
• 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. Thecentral engine10 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.
• FIGS. 2A-D illustrate examples of security techniques that may be employed by an architecture according to aspects of the present invention. As shown inFIG. 2A, thecentral engine10 may prompt the user for a user ID and password, personal identification number (PIN), or other authentication information, when amodule30 attempts to interface with thecentral engine10 or to access data through the system. Themodule30 is only allowed connection or data access if the response to the security prompt corresponds with authentication information stored at the system. For example, themodule30 may be a PC executing a data-management program that uploads test data from a blood-glucose meter connected to thecentral engine10. When the program attempts to communicate through an interface connection or tries to access data, the user must submit a user ID and password. The authentication information may be entered through a user interface, e.g. a keypad or keyboard, on the PC or thecentral engine10. If themodule30 is used frequently to access data through thecentral engine10, the user may find it inconvenient to enter authentication information repeatedly. Thus, some embodiments may allow a user to set a time period (from zero to infinity) between authentications from theparticular module30. Thecentral engine10 records a unique identifier, e.g. device ID, formodule30 to keep track of the time period. For instance, a security prompt may be required if the specified time, e.g. one day, has passed since the last authentication. Alternatively, the user may stop all further security prompts from occurring after the first authentication. In this alternative case, the first authentication acts as a registration with thecentral engine10 to permit all future access from themodule30.
• As shown inFIG. 2B, a unique identifier, e.g. device ID, formodule30 may be registered with thecentral engine10. This unique identifier may be entered by the user or recorded when the authentication process shown inFIG. 2A is completed for the first time. Alternatively, registration of themodule30 may be achieved through an initial, e.g. factory, set-up process. In this alternative case, registration of additional modules may be prohibited after the initial set-up, thereby fixing the number of modules in the system. When themodule30 subsequently attempts to connect or access data, thecentral engine10 automatically recognizes themodule30 and permits access.
• In the embodiments ofFIGS. 2A and 2B, themodule30 is authenticated or registered in a one-way process. In other words, thecentral engine10 is not required to be authenticated or registered with themodule30. In contrast, as shown inFIG. 2C, both thecentral engine10 and themodule30 are required to be registered with each other. Matching of unique identifiers for the pair is required before any communication takes place between thecentral engine10 and themodule30. This pair matching is particularly applicable to wireless communication between two devices. The process prevents intentional unauthorized access, and also prevents interference between two different systems. For example, if a user is in a setting, such as a hospital or clinic, where others are using similar wireless analyte-testing devices, such as blood-glucose meters, pair matching prevents another person's blood-glucose meter from accidentally communicating with the user's diagnostic system and providing the wrong data.
• Data security may also be enhanced by using encrypted data during communications, as shown inFIG. 2D. This is also particularly applicable to wireless communications, so that any intercepted data will be unreadable. The data encryption may be achieved by using private encryption keys.
• Data security may be further enhanced by ensuring that all data is stored by thecentral engine10 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.
• FIG. 3 provides a non-limiting example of a diabetes-management system100 that can be formed from the architecture approach described herein. The diabetes-management system100 is advantageous to those individuals who are actively involved in monitoring and recording measurements of their blood glucose concentrations and/or other analytes of interest.
• As shown inFIG. 3, the diabetes-management system100 includes a blood-glucose meter (BGM)310, a continuous glucose monitoring (CGM)module320, an insulin-delivery device330, and acomputing device370, which may include diabetesdata management software375. Themodules310,320,330, and370 are combined, as described further below, using the architecture approaches described herein to provide health monitoring and delivery functions for the diabetes-management system100. In particular, theBGM310 provides point-in-time measurements of blood-glucose concentrations in blood samples; theCGM module320 provides continuous measurements of blood-glucose concentration; and the insulin-delivery device330 delivers insulin to the user.
• In addition, thecomputing device370 executes thesoftware375 to receive data from themodules310,320, and330 and provides advanced data processing and management capabilities. Thecomputing device370 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 thecomputing device370 is a desktop or laptop personal computer, the operating system may be a version of Microsoft® Windows®. Alternatively, if thecomputing device370 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 device370 includes a processor that is capable of receiving and executing any number of programmed instructions.
• The data-management software375 on thecomputing device370 may be a collection of programs or computer code that receives and processes data measured by themodules310 and320, for example. Thesoftware375 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 themodules310 and320 may include, for example, the concentration of glucose and/or other analytes in a person's blood or other bodily fluid. Advantageously, thesoftware375 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, thesoftware375 may include a product similar to WINGLUCOFACTS® Diabetes Management Software available from Bayer HealthCare LLC (Tarrytown, N.Y.). As such, thesoftware375 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 thesoftware375 does not upload data from themodules310 and320 to thecomputing device370 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 thecomputing device370. Moreover, the use of embodiments of the present invention are not using theparticular modules310,320,330, and370.FIG. 4 illustrates a broader system diagram withother modules300. For instance, asFIG. 4 illustrates, an A1_Cmodule340, which monitors glucose control over time, may also be used in a diabetes-management system. Themodules300 also include otherhealth monitor modules350, such as blood pressure and heart rate monitors. Indeed,modules300 may measure and/or record health data that do not require analyte testing, such as temperature measurements, blood pressure measurements, heart rate measurements, breathing measurements for chronic obstructive pulmonary disease (COPD) analysis, weight measurements for analyzing Lasix use, and the like. In further systems, otherutility device modules360 may include training modules, connectivity modules providing further connection to other systems, and other modules that improve or enhance a user's experience with the system. For example, it is contemplated that entertainment or media modules such as game modules or music player modules may be combined with the systems described herein. Providing entertainment features, for example, may encourage patients, particularly young patients, to keep the diagnostic systems with them wherever they go, so that health conditions, such as diabetes, can be monitored regularly. Furthermore, in some systems, the architecture may also employ open source code so that additional custom or specialized modules may be developed by users or third parties for integration with the architecture described herein. Accordingly, an endless variety of modules providing any type of functionality may be employed.
• As shown inFIG. 3, the system100 includes acentral engine110, such as a digital engine, for the architecture and enables themodules300 to be easily and effectively combined. For example, thecentral engine110, theBGM310, theCGM module320, and the insulin-delivery device330 can be effectively combined to create an artificial pancreas. Alternatively, thecentral engine110, theBGM310, and theCGM320 can be combined to form a CGM with an embedded BGM unit. Or as a further example, thecentral engine110, theBGM310, and the insulin-delivery device330 can be combined to form a pump controller with an embedded BGM unit.
• Referring again toFIG. 4, thecentral engine110 may include aprocessor112 and apower management element114. Theprocessor112 is capable of receiving and executing any number of programmed instructions, and may be a microcontroller, microprocessor, digital signal processor, or the like. The programmed instructions to be executed by theprocessor112 may be embedded or may be retrievable from astorage device250, aconnected module300, or another source such as an Internet website. Theprocessor112 centrally manages communications with themodules300. In some cases, theprocessor112 may also execute software that handles the operation of somemodules300. Moreover, theprocessor112 may give themodules300 access to common resources or features such as theuser interfaces220 described further below.
• Power management element120 distributes power from a power supply to theprocessor112 as well asmodules300 that do not have their own power source. Thepower management system114, 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, thepower management system114 may also handle the recharging of the battery.
• As also shown inFIG. 4, thecentral engine110 is connected to input/output interfaces200, which can be divided into two different categories:communication interfaces210 anduser interfaces220. The communication interfaces210 govern the exchange of data between thecentral engine110 and themodules300. In general, the communication interfaces210 can accommodate wired and/or wireless communications. Wired communications include, for example, communications by universal serial bus (USB) connection. Wireless communications include, for example, radio-frequency (RF) links (e.g., a short-range RF telemetry), infrared (IR) links, and/or Wi-Fi. Some known RF technologies, for example, include Bluetooth® wireless technologies, Zigbee, Z-Sense™ technology, FitSense, and BodyLAN™ system. It is understood that other communication technologies, or protocols, may be employed.
• Referring again toFIG. 3, a wired, or physical,connection212 exists between thecentral engine110 and thecomputing device370 while awireless connection214 exists between thecentral engine110 and each of theCGM module320 and the insulin-delivery device330. It is noted that theBGM310 is assembled with thecentral engine110 in thehousing101. As such, the interface between thecentral engine110 and theBGM310 involves a wired connection (not shown). Indeed, asFIG. 3 illustrates, themodules300 may be combined in any suitable arrangement in relation to thecentral engine110 and toother modules300. Like theBGM310, somemodules300 may be assembled with thecentral engine110 within the same housing, whileother modules300 may be provided in separate housings and arranged remotely from thecentral engine110. It is also contemplated that in addition to other configurations described herein, somemodules300, having the form of circuit components, for example, may be assembled on the same printed circuit board assembly (PCBA) as circuit components for thecentral engine110 with a circuit connection providing theinterface210.
• FIG. 5 illustrates a further example of a connection between thecentral engine110 and amodule300, namely theBGM310. UnlikeFIG. 3, theBGM310 ofFIG. 5 is not disposed in ahousing101 with thecentral engine110, but the description provided with reference toFIG. 5 is equally applicable to the configuration inFIG. 3.
• Referring toFIG. 5, theBGM310 with atest sensor316 is illustrated. Thetest sensor316 is configured to receive a fluid sample which is analyzed using theBGM310. Analytes that may be analyzed include glucose, lipid profiles (e.g., cholesterol, triglycerides, LDL and HDL), microalbumin, hemoglobin A1_Cfructose, lactate, or bilirubin. It is contemplated that other analyte information may be determined (e.g., analyte concentrations). The analytes may be in, for example, a whole blood sample, a blood serum sample, a blood plasma sample, other body fluids like ISF (interstitial fluid) and urine, and non-body fluids.
• Thetest sensor316 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 thetest sensor316 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.
• Thetest sensor316 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, thetest sensor316 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® andBREEZE®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 inFIG. 5, theBGM310 receives and engages thetest sensor316. TheBGM310 includes a reaction-detection system for measuring the concentration of analyte for the sample collected by thetest sensor316. For example, the reaction-detection system may include contacts for the electrodes to detect the electrochemical reaction for an electrochemical test sensor. Alternatively, the reaction-detection system may include an optical detector to detect the chromatic reaction for an optical test sensor. To calculate the actual concentration of analyte from the electrochemical or chromatic reaction measured by the reaction-detection system and to generally control the procedure for testing the sample, theBGM310 employs at least oneprocessor312, which may execute programmed instructions according to a measurement algorithm. Data processed by theprocessor312 may be stored in amemory313. Furthermore, theBGM310 may have auser interface315 that includes a display, which, for example, may be a liquid-crystal display. Pushbuttons, a scroll wheel, touch screens, or any combination thereof, may also be provided as a part of theuser interface315 to allow a user to interact with theBGM310. The display typically shows information regarding the test results, the testing procedure and/or information in response to signals input by the user.
• Although theBGM310 can store test results and provide auser interface315 to display test results, the data-management software375 on thecomputing device400 provides more advanced functionality for managing, processing, and displaying test results and related information. Therefore, the test-related data collected by theBGM310 can be communicated via thecentral engine110 to thecomputing device370 for use with the data-management software375. As shown inFIG. 5, theBGM310 includes aBGM interface element311 that enables theBGM310 to connect with thecentral engine110 via theengine interface element111. Furthermore, thecentral engine110 is connected to theengine interface element116 which in turn is connected tocomputer interface element376 ofcomputing device370. TheBGM interface element311, thecomputer interface element376, and theengine interface elements111 and116 may employ the interface technologies described above to make the devices compatible and enable the appropriate data connections. For example,engine interface111 andBGM interface311 may connect via Bluetooth® wireless, while theengine interface111 may connect to thecomputer interface376 through a connection to a USB port. Thus, it is readily seen that although theBGM310 and thecomputing device370 may not have compatible interfaces, the architecture ofFIG. 5 enables data to be exchanged between them. Moreover, it is also readily contemplated that the development of theBGM310 can be accomplished without regard to direct compatibility with USB interface of thecomputing device370.
• As discussed previously, thecentral engine110 has thepower management114 which may include a power supply that is rechargeable via the connection with thecomputing device370 or some other power source. When thecentral engine110 and theBGM310 are connected, a rechargeable battery can be recharged viapower management314.
• As described previously, theBGM310 inFIG. 5 employs at least oneprocessor312, which may execute programmed instructions. Moreover, theBGM310 may have auser interface315, which includes a display to present information to the user, as well as pushbuttons, a scroll wheel, touch screens, or any combination thereof to enable interaction by the user. With such components, theBGM310 generally controls the whole procedure for testing the sample and calculates the test results. Indeed, the description provided with reference toFIG. 5 generally explains how the test results already calculated by theBGM310 may be subsequently shared with other modules such as thecomputing device370. However, it is contemplated that theprocessor112 of thecentral engine110 can also provide a wider range of functions. In fact, it is further contemplated that the processing in a health monitoring and delivery system can be distributed among the components, including thecentral engine110, in varying manners.
• For example,FIG. 6 illustrates a sensor-receivingmodule380 that requires other components to handle substantially all of the processing. Like theBGM310, the sensor-receivingmodule380 is configured to receive atest sensor316. However, the sensor-receivingmodule380 does not have a processor to manage the testing procedure or to calculate test results. In addition, the sensor-receivingmodule380 has no user interface to communicate with the user. In general, the sensor-receivingmodule380 is designed to merely receive atest sensor316 and to provide aninterface element381 for physical connection to the rest of the diagnostic system. As a result, analysis of the test sample on thetest sensor316 is only possible when the sensor-receivingmodule380 connects with a device that has a processor to analyze the sample via theinterface element381.
• As shown inFIG. 6, theinterface element381 of the sensor-receivingmodule380 is connected to theinterface element111, which in turn is connected to thedigital sensor110. It is noted that the connection between the sensor-receivingmodule380 and thecentral engine110 may require a host function, such as the USB host function, to be employed by thecentral engine110. In one embodiment, thedigital sensor110 is also connected to theinterface element376 of thecomputing device370. The interfaces between the sensor-receivingmodule380, thecentral engine110, and thecomputing device370 may employ any of the interface technologies, such as USB or Bluetooth® technology, described above. Accordingly, thecomputing device370 can executesoftware377 to control the procedure for testing a sample and calculating the test results in a manner similar to theprocessor312 onBGM310 inFIG. 5. In operation, the sensor-receivingmodule380, thecentral engine110, and thecomputing device370 are connected as shown inFIG. 6. Thetest sensor316 is used to collect a fluid sample, such as a blood sample. If, for example, thetest sensor316 is an electrochemical test sensor, the sensor-receivingmodule380 system may include electrical contacts to receive the electrical signal from the electrochemical reaction that occurs between the sample and the reagent on thetest sensor316. The connection between the sensor-receivingelement380 and thecentral engine110 is connected to the circuit containing the electrical sensors so that thecentral engine110 receives the electrical signal from the electrochemical reaction. This signal can then be passed to thecomputing device370 to process the signal and determine the test results using a measurement algorithm. The user interface on thecomputing device370 can be used to display the test results or to receive instructions from the user.
• It is understood that other techniques may be employed to communicate a signal from the sensor-receivingmodule380. For example, atest sensor316 may be an optical test sensor and the sensor-receivingsystem380 may include an optical detector to detect a chromatic reaction. If the sensor-receivingmodule380 requires any power to receive or process a signal from thetest sensor316, the power can be drawn through its connection with thecentral engine110.
• Alternatively, in another embodiment, thecomputing device370 is not employed in the system, so that the sensor-receivingmodule380 is only connected to thecentral engine110 as shown inFIG. 7. As such, the test result calculations are completed by theprocessor112 of thecentral engine110 and the test results are displayed on a user interface connected to thecentral engine110. As shown inFIG. 7, auser interface115 may be incorporated into thehousing101.
• Themeasurement software253 for controlling the test process and determining the results may be available through thestorage device250 as illustrated inFIG. 7. As illustrated inFIG. 4, thestorage device250 corresponds with another type of input/output interface200. Thestorage device250 may be a flash memory device, such as a universal serial bus (USB) flash drive or a memory card. USB flash drives are also known as thumb drives, handy drives, flash sticks, or jump drives. Memory cards may have a variety of 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, or some variation thereof. Flash memory devices may employ non-volatile memory so that the software associated with themeasurement software253 may be retained in thestorage device250 even when thestorage device250 receives no power. In some embodiments, the memory in thestorage device250 may include execute-in-place (XIP) memory, such as NOR flash memory, so that themeasurement software253 stored on the memory can be executed directly. It is also contemplated that thestorage device250 may employ other storage media, such as floppy disk or optical disc (CD, DVD, Blu-ray disc).
• Thestorage device250 may be assembled with thecentral engine110 in thehousing101, as shown inFIG. 7, or it may be connected to thecentral engine110 in a manner similar to an external module (e.g., module300). Particularly in the latter case, thestorage device250 may interface with acommunications interface210 and connect to thecentral engine110. The interface enables data communications between thestorage device250 and thecentral engine110 and permits themeasurement software253, or any other software, to be used withcentral engine110. In particular, thestorage device250 has an interface element that is compatible with aninterface element210. In some embodiments, the storage-device interface element physically engages theinterface element210 to form a serial hardware interface. For example, thestorage device250 may be a USB flash drive, and the storage-device interface element may be a USB connector that is received into a USB port, which acts as thecommunications interface element210 for thecentral engine110.
• As a further example, thestorage device250 may be a Secure Digital (SD) memory card with a series of contacts that act as the interface element, and thecommunication interface210 may be an expansion slot that receives the contacts of the memory card. In this example, thecentral engine110 and thestorage device200 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 thecentral engine110 inFIG. 7 is filling the role of thecomputing device370 in the example ofFIG. 6, higher-powered processing devices may be required. For example, some embodiments may employ handheld or pocket personal computers (HPCs), compatible personal digital assistants (PDAs), or smart cellular phones. As discussed above, these processing devices may employ a variety of operating systems and configurations. For example, if thecomputing device370 is a PDA, the operating system may correspond with those of PALM® handhelds from Palm, Inc., or Blackberry® devices from Research in Motion Limited. Advantageously, PALM® handhelds and Blackberry® devices provide a portable device with enough processing power to reliably execute advanced data management software for results collected from the sensor-receivingmodule380. Moreover, such devices provide rich user interfaces that provide advanced graphical display capabilities. In addition, because these handheld devices connect to external networks, such as the Internet, new software or software upgrades/patches can be readily installed. Furthermore, the connection to the telecommunications network enables test results to be easily transmitted to doctors and other healthcare professionals for monitoring or evaluation. Because many consumers already carry these or similar devices, many users of a diagnostics system, such as a diabetes-management system, would conveniently incorporate the system in devices they already own and carry regularly.
• Because embodiments may employ many different types ofmodules300 that may be situated on different types of hardware, the communication interfaces210 generally have to accommodate more than one type of communication technology, or protocol. However, to minimize the number ofcommunication interfaces210 while providing the widest range of compatibility between thecentral engine110 and thevarious modules300, the communication interfaces210 can employ widely-used and standardized interface technologies, such as USB or Bluetooth® technology. Preferably, the communication interfaces210 employ technologies that minimize the amount of configuration required to establish communication between amodule300 and thecentral engine110. Indeed, some communication technologies, such as USB connectivity, provide plug-n-play (PnP) capability. In these embodiments, themodule300 is physically connected, for example, through a conventional USB port. Then in response, thecentral engine110 immediately recognizes themodule300 and establishes immediate communication with themodule300,
• The communication interfaces210 not only provide communication betweenmodules300, 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 themodules300 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 thecentral engine110 and/or themodules300, 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 theBGM310 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 theBGM310 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 themodules300, 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, thecentral engine110 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 inFIG. 9, once a connection is established with a field upgrade server in an appropriate external network (act502), an available field upgrade is identified for an existing system component, e.g., new software or configuration information, (act504). The connection to the server may be triggered automatically when a connection to the network may be established, or a user may manually initiate communication with the field upgrade server. To identify an available field upgrade, the central engine or the server may employ a version management program to determine which system components in the architecture are compatible with, and can be replaced by, newer or different versions stored on the field upgrade server. The new system component is then downloaded from the field upgrade server to a memory, i.e., data storage area, that is separate from the memory area storing the existing system component. An area of memory may be specifically dedicated for field upgrade operations. In other words, the existing system component is retained, rather than deleted or written over at least until validation is complete. The new system component is validated with a system check (act508), and if the download has been successful and the system operates properly, the new system component is deployed for regular system operation. Thus, if the field upgrade fails, the previous version of the system component is still available and provides a recovery or restore option. The new system component is removed with a failed field upgrade. In some embodiments, the new version may replace the previous version in memory after the new version is validated. In other embodiments, the one or more previous versions are retained even after validation and users may have the option to restore one or more previous versions of a system component if an older version is preferred.
• An example embodiment is described with reference toFIG. 8. In the embodiment ofFIG. 8. the diabetes-management system400 may includemodules402,403,404, and405 which collect fluid samples. Thedigital engine406 controls each module,user interface413,memory407, and thedownload engine408.Download engine408 provides an interface between one of the communication modules,digital engine406, andmemory407. The communications modules may includeUSB interface409 which provides, for example, communication between a computing device USB port and the system401. The communication module may also include aBluetooth interface410 which provides wireless communication between thesystem400 and a computing device, cell phone, and/or other devices capable of communicating with thesystem400. Furthermore, a Wi-Fi interface411 provides communication between a wireless network and thesystem400. Additionally, theEthernet interface411 provides communication between a local area network and thesystem400. Each communication module can be used to upgrade/update the meter's software in the field upon the user's direction. The following features may also be downloaded per user request: new firmware for new functions; new firmware to update the behavior of current system functions; user interface language; screen updates and customization; games and other standalone applications; gauges; and other software or configuration settings/updates.
• 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 thesystem400 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 toFIG. 4, the input/output interfaces200 also includeuser interfaces220, which generally allow themodules300 to display information, such as test results, to the user. Themodules300 may transmit such information to thecentral engine110 viacommunication interfaces210, and thecentral engine110 may in turn present the information on the display interfaces220. Although centralized handling of communications may be preferred, themodules300, in some cases, may interface directly with the display interfaces220. As shown inFIG. 2, the display interfaces may include graphic liquid crystal display (LCD) or organic light-emitting diode (OLED), segment LCD or OLED, MP4 playback, or the like.
• In addition, the input/output interfaces200 may allow information to be communicated to and from the user via audio signals. For example, the input/output interfaces200 may include a speech synthesizer, MP3 playback, or the like, for communicating audio information to a user. Additionally, the input/output interfaces200 may also include a speech recognition mechanism to receive audio information from a user.
• Furthermore, theuser interfaces200 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 themodules300 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 interfaces220. Mechanisms for providing input, for example, may include a keypad, a touch screen, a thumb wheel, or the like.
• As shown inFIG. 7, auser interface115 may be incorporated into thehousing101 in which thecentral engine110 andcorresponding communication interfaces210 are assembled. As such, thehousing101 may form aportable device101 for a health monitoring and delivery system. As discussed previously with reference toFIG. 3, somemodules300, such as theBGM310, may be incorporated into the device, while other modules, such asCGM320 and theinsulin delivery module330, may be externally connected to theportable device101 through the communication interfaces210. Themodules300 connected to thedigital engine310 have access to the interface
• Systems employing the architecture support various types of electronic networks and communications.Modules300 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 acomputing device370 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 thecentral engine110 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.

Claims (7)

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 ofclaim 1, wherein the first central engine is assembled with the first set of at least one module according to a first development process and the second central engine is assembled with the second set of at least one module according to a second development process.

3. The system ofclaim 1, wherein the communication interface is at least one of a USB interface, a radio frequency (RF) interface, a Wi-Fi interface, and an Ethernet interface.

4. The system ofclaim 1, wherein the first central engine is implemented on a first mother board, the second central engine is implemented on a second mother board, the first set of at least one module is separately implemented on a first set of at least one daughter board, and the second set of at least one module is separately implemented on a second set of at least one daughter board.

5. The system ofclaim 1, further comprising a first housing including the first central engine and a second housing including the second central engine.

6. The system ofclaim 1, wherein the first set of at least one module provide a diabetes-management system.

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.

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