HK1111331B - Apparatus and method to administer and manager an intelligent base unit for a handheld medical device - Google Patents

Description

Apparatus and method for manipulating and managing an intelligent base unit of a handheld medical device

Technical Field

The present invention relates to handheld medical devices, and more particularly, to an apparatus for manipulating and managing an intelligent base unit of a handheld medical device and a method thereof.

Background

Some prior art point of care (POC) systems include a base unit, cradle, or docking station that provides stable positioning and location for a handheld medical device. The base unit also provides a communication layer for communicating the associated handheld medical device with a computer system or other information technology device, as well as for charging the battery of the handheld medical device. Historically, the base unit for such POC systems has been used as a "dumb" pass-through terminal, controlled only by hardware. In order to improve flexibility and achieve better system integration performance, it is imperative that such POC systems be provided with base units with built-in intelligence, i.e. microcontrollers and control streams provided as some embedded firmware.

However, when a microcontroller and embedded firmware are provided, the base unit needs to be manipulated and managed like the handheld medical device itself. These management requirements include, for example, setting configuration items through user and firmware upgrades, where such prior art base units are slaved to a remote computer system in order to perform these management requirements. By making the base unit a slave to the remote computer system, the problem arises that the point in time at which the update takes place may be totally insufficient. Typically, a remote computer, such as a central management database server, is unaware of the various circumstances in a distributed setting.

It must be understood that in order to reduce complexity and cost, the base unit does not typically include a user interface, i.e. a display or other means for user input, such as buttons. Without tolerating these cost advantages and adding support devices for user input/output, the base unit cannot be directly configured and manipulated (e.g., as is the case with POC devices themselves).

Disclosure of Invention

Contrary to the background art discussed above, the inventors of the present invention have recognized the need for a "smart base unit" as described in the present application. The inventors of the present invention have realized that in addition to the computer system described above, a handheld medical device, such as a blood glucose meter, may be used as a master device to manipulate and manage the smart base unit. This active control of the handling and management process of the intelligent base unit is improved over the prior art in the following respects: various aspects of the base unit may be taken into account before providing the updates in order to meet quality, reliability and product safety requirements.

Moreover, among other advantages and improvements, the present invention reduces the complexity and manufacture of the smart base unit. The present invention takes advantage of the fact that the handheld medical device itself is connected to some host via the base unit using typical daily communication flows. Thus, the handheld medical device controls the base unit for the purpose of manipulating and managing the base unit. In this way, it is assumed that the user instructing the base unit to be updated is physically close, thereby preventing the base unit from being used for other purposes, and allowing the user to control the management process. These assumptions greatly simplify the design of such base units.

In one embodiment, a method of providing a handheld medical device and a base unit in communication with the handheld medical device is disclosed. The base unit is configured to provide an electrical connection to a power source for charging a battery of the handheld medical device. The method includes performing an update to the operation of the base unit, wherein the update is initiated by the base unit upon receiving a data stream from the handheld medical device, the data stream having information indicating that the update is contained in the data stream.

In another embodiment, a method of providing a base unit and a handheld medical device in communication and electrical interface with the base unit is disclosed. The method includes receiving, with the handheld medical device, an update provided via the base unit, wherein the base unit ignores the update. The method also includes communicating the update in a data stream from the handheld medical device to the base unit, wherein the handheld medical device adds additional information to the data stream, and receiving the data stream with the base unit, wherein the base unit does not ignore the update because the additional information is detected.

In another embodiment, a method for operating and managing a system is disclosed. The method comprises the following steps: providing a request unit in two-way communication with the handheld medical device via the base unit; transmitting a query from the requesting unit to obtain device data from the handheld medical device; and communicating the query to the handheld medical device via the base unit. The method also includes transmitting device data from the handheld medical device to the requesting unit via the base unit, the device data including status information associated with the handheld medical device and the base unit. The method further includes checking the status information to see if an update to the software or firmware of the handheld medical device or the base unit is required; and sending updates from the requesting unit to the handheld medical device via the base unit when needed.

In another embodiment, an apparatus is disclosed. The apparatus includes a handheld medical device including a microprocessor, a first communication interface, and a battery to power the handheld medical device. A base unit having an electrical connection configured to be powered from a power source to charge a battery of the handheld medical device is also provided. The base unit also includes a second communication interface configured to communicate with the first communication interface of the handheld medical device and a microcontroller configured to update the manipulation of the base unit. The update is initiated by the base unit upon receiving a data stream from the handheld medical device via the first and second communication interfaces, the data stream having information indicating that the update is contained in the data stream.

These and other features and advantages of the present invention will be more fully understood from the following description of various embodiments of the invention taken together with the accompanying drawings.

Drawings

Fig. 1A and 1B are perspective front and back views, respectively, of a base unit and a handheld medical device according to an embodiment of the invention.

Fig. 2 is a perspective view of a handheld medical device managed by a base unit according to an embodiment of the invention.

FIG. 3 is a system block diagram for handling and managing a plurality of handheld medical devices, such as Blood Glucose Meters (BGMs), according to an embodiment of the invention.

FIG. 4 is a flow chart of an interrogation of a handheld medical device according to an embodiment of the invention.

FIG. 5 is a flow chart of a handheld medical device interrogating a base unit according to an embodiment of the invention.

FIG. 6 is a flow chart of updating a base unit from a handheld medical device via active control according to an embodiment of the present invention.

Detailed Description

Referring to fig. 1-3, an example of a handheld medical device, a hospital Blood Glucose Meter (BGM)10, and a base unit 12 are disclosed. The base unit 12 comprises a carrier 14 which houses the BGM 10. When an operator desires to use the BGM10, the operator lifts the BGM10 from the carriage 14, as indicated by arrow 16 in fig. 1. The BGM10 is placed or returned to the carriage 14 as indicated by arrow 18.

The base unit 14 includes a power cord 20, a port connection 22, and a network connection 24, as shown in FIG. 2. The power line 20 supplies power from an external power source to charge the BGM 10. The port connection 22 is a USB connection in one embodiment, but may be other types of port connections, such as firewire, serial or parallel connections. The network connection 24 is a TCP/IP communication compatible ethernet network in one embodiment, and may be compatible with other types of network protocols in other embodiments.

As shown in fig. 3, the seating of the BGM10 in the carrier 14 provides an electrical connection 26 between the communications interface 28a of the BGM10 and the communications interface 28b of the base unit 12. The electrical connection communication interfaces 28a and 28b provide bi-directional communication between the BGM10 and the electronic device 30 via the port connection 22 connected to the base unit 12. The electrically connected communication interfaces 28a and 28b also provide bi-directional communication between the BGM10 and the remote station 32 over a network 34 via the network connection 24 connected to the base unit 12.

The electronic device 30 and the remote station 32 may be any type of computer including laptop computers, pagers, Personal Digital Assistants (PDAs), computer systems, computer servers, printers, mobile phones, and any medical or electronic device having an embedded microprocessor running software compatible with the BGM10 and the base unit 12 and communicating with the base unit 12. The electronic device 30, as connected to the base unit 12 via the port connection 22, is typically located in the same physical location (i.e., the same room) as the base unit 12. The remote station 32, because it is connected to the base unit 12 via the network connection 24 to the network 34, may be located anywhere where the network connection 24 is provided by the network 34, which may also be the same physical location as the base unit 12.

The network 34 may be any network. Network 34 includes, for example, a public switched telephone network, a cellular telephone network, a local area network, a wide area network, a global computer network such as the internet, an integrated services digital network, and so forth. In some arrangements of the configurable BGM10 and base unit 12, the arrangement may include a private secure network or a private setup and maintenance network. Both of which may be used as the network 34. Network 34 may include hardwired electrical or optical communication links, wireless links, or a combination of both.

The electrically connected communication interfaces 28a and 28b also provide bi-directional communication between the BGM10 and the base unit 12 via a physical communication link. When the base unit 12 receives the BGM10, the matching electrical or optical components in the base unit 12 and BGM10 will engage, enabling communication.

In another embodiment, the communication interfaces 28a and 28b may provide a wireless connection 36 for two-way communication between the BGM10 and the base unit 12, as shown in fig. 2. Communication between the BGM10 and the base unit 12 may employ a suitable communication protocol in accordance with one or more wireless communication links, such as radio frequency, capacitive, inductive, and infrared links. For example, one communication protocol, commonly referred to as bluetooth, employs short-range wireless technology for transmitting data between devices. Other possible communication protocols include ieee802.11a, 802.11b, and 802.11g, and proprietary wireless communication layers in any (industrial, scientific, and medical) ISM band. Other possible protocols include IrDA, SIR (serial Ir) and any other optical protocol.

Further, the BGM10 and the base unit 12 may communicate via a combination of wireless and physical communication links. Both the wireless link and the physical communication link may be implemented such that the BGM10 may be quickly and easily removed from the base unit 12 without obstruction. In this embodiment, the base unit 12 is a wireless access node for the BGM10, providing two-way communication between the BGM10 and the electronic device 30, and between the BGM10 and the remote computer 32.

The positioning of the BGM10 in the carrier 14 also provides an electrical connection 38 between the battery terminal 40a of the BGM10 and the battery terminal 40b of the base unit 12. The electrical connection between the BGM10 and the base unit 12 may be a physical connection or an inductive coupling. The electrical connection of the battery terminals 40a and 40b provides electrical power from a power supply 42 of the base unit 12 to a battery 44 of the BGM10 for recharging. The power supply 42 is connected to an external power supply 46 via the power cord 20.

The battery 44 powers the components of the BGM10, such as the communication interface 28a, the measurement system 48, the microprocessor 50, the memory 52, and the user interface 54. The power supply 42 powers the components of the base unit 12, such as the communication interface 28b, the microcontroller 56, and the memory 58.

The measurement system 48 measures glucose in a patient's blood sample and provides an output for monitoring the patient's blood glucose level. The microprocessor 50 controls the various functions of the BGM 10. For example, the microprocessor 50 executes user-entered commands, manages charging of the battery 44, and evaluates outputs from the measurement system 48 to provide information to the user via the user interface 54 relating to the patient's measured blood glucose level(s). The microprocessor 50 also reads and writes the memory 52, communicates with the electronic device 30 and/or the remote station 32, executes a program that performs the self-diagnostic routine 60 of the BGM10, and acquires BGM status information related to the execution of the self-diagnostic routine. The microprocessor 50 also queries the Base Unit (BU) status information of the base unit 12 and obtains BU status information relating to the queried base unit. Interrogation of the microprocessor 50 will be described in further detail below with reference to fig. 4 and 5.

The BGM state information relates to the operational state of the BGM10 and its related components. The BGM state information includes, for example, data indicating that the BGM10 is in a good operating state. The BGM status information may also include data indicating that the BGM10 has failed or is potentially problematic, such as data indicating that a failed or damaged component has occurred. The BGM status information also includes, for example, data indicating that the battery 44 is low, or that the battery is unable to hold charge. The BGM status information may also include data representing the serial number of the BGM, the physical location of the BGM, the communication settings of the BGM's communication interface 28a, and the current software and/or Firmware (FW) version stored in memory 52. As described herein, communication settings include the definition of the static IP address of the meter itself, the definition of the meter's IP subnet mask, and the definition of timeouts or various other parameters that affect host communications.

It should be appreciated that the self-diagnostic routine 60 monitors the state of the BGM 10. The self-diagnostic routine 60 may be routinely performed by the microprocessor 50, for example, at power-on, or at any other time or upon a triggering event, such as being unseated and/or mounted on the base unit 12, or upon a user request. The self-diagnostic routine 60 may also be initiated by an interrogation from the electronic device 30 or the remote station 32, or may be initiated in response to a change in a condition of the BGM10 (e.g., a component failure).

By executing the self-diagnostic routine 60, the processor 50 performs one or more internal tests to obtain status information regarding the ready state of the BGM 10. The self-diagnostic routine 60 also evaluates and identifies events that may be operated by the user, such as software or firmware updates, and events that require a professional service call. The BGM status information from the self-diagnostic program 60 is stored in a data file 62 that is saved in memory 52 and some or all of the status information may be presented via the user interface 54. When the result of the self-test indicates that the BGM10 is in the ready state, for example, the user interface 54 may provide a visual or audible indication of readiness. Further, the data file 62 or selection information provided therein may be provided to the electronic device 30, the remote station 32, and/or another BGM upon request and/or after performing the self-diagnostic routine 60.

The microcontroller 56 controls various other functions of the base unit 12. For example, the microcontroller 56 monitors and manages the power supplied from the power source 42 to the battery terminal 40b, and disconnects the power source when a fault condition is detected. The microcontroller 56 also reads and writes memory 58 and communicates with the BGM10 via the communication interface 28 b. Upon receiving an interrogation from the BGM10 via the communications interface 28b, the microcontroller 56 executes a program from the memory 58 that performs a self-diagnostic test 64 of the base unit 12.

It should be understood that the self-diagnostic test 64 monitors the status of the base unit 12. The self-diagnostic test 64 may be initiated by the microcontroller 56 by receiving an inquiry from the BGM10 or may be initiated in response to a change in the condition of the base unit 12. The self-diagnostic test 64 may evaluate and identify events available to the user, as well as events requiring a professional service call. In one embodiment, the base unit 12 transmits BU status information to the BGM10 and applies the received updates in connection with performing the self-diagnostic test 64. Microcontroller 56 may also execute additional commands entered by the user via BGM10, such as adjusting configuration settings, reporting usage events, serial information, and accepting location information.

The BU status information relates to the operational status of the base unit 12 and its associated components. The BU state information includes, for example, data indicating that the base unit 12 is in a good operating state. The BU status information may also include data indicating a malfunction or potential problem with the base unit 12, such as data indicating a malfunctioning or damaged component. The BU status information may also include data representing, for example, the serial number of the base unit, the physical location of the base unit, the communication settings of the communication interface 28a, the number of seating events for usage/wear measurements, and the current software and/or Firmware (FW) version of the base unit. As described herein, the communication settings include the definition of the base unit's own static IP address, the definition of the base unit's IP subnet mask, and the definition of timeouts or various other parameters that affect host communications. The BU state information, like the BGM state information, is stored in the data document 62 of the BGM 10.

User interface 54 of BGM10 may include one or more input-output elements 66 that communicate state information to a user. These input-output elements also communicate test information to the user, such as part of a blood glucose test procedure performed by the BGM 10. As shown in fig. 1A, 1B and 2, the input-output elements 66 include a touch screen display 68, selector buttons 70, a test reader 72 and an optical reader 74. It should be understood that test reader 72 enables reading of a test carrier, such as a test strip, a test card (cassette), a cartridge (cartridge), or any other suitable test carrier. The input-output elements 66 may include other or additional elements, such as a speaker 76 capable of communicating voice signals or voice messages, and a microphone 78 for receiving audio commands from a user.

In one illustrative embodiment, FIG. 2 shows how the BGM10 may be used to manipulate the base unit 12. The BGM10 communicates wirelessly with the base unit 12 shown via a wireless connection such as IrDA. The user holds the BGM10 and directs the communication interface to the base unit 12. Furthermore, the BGM10 may be mounted in the base unit 12 such that the IrDa windows of the two devices are aligned while performing this action. The user then retrieves the BU state information and/or utilizes the input-output element 66 of the BGM10 to determine and provide all communication and operational settings of the base unit 12. In particular, the touch screen display 68 of the BGM10 shows an illustrative screen shot. In one embodiment, the touch screen display 68 of the BGM10 has the option of presenting display content that is rotated 180 degrees. This option applies to the following cases: the user holds the BGM10 in his or her hand for the programming operation described above, but in an orientation that is different from the orientation in the normal workflow process of a meter performing blood glucose monitoring.

The touch screen display 68 may communicate, for example, that the BGM10 and base unit 12 are in good working order, or that the communications interface of the BGM10 and base unit 12 are working properly. The touch screen display 68 may also receive input from a user and then convey any information, such as graphical instructions, or text that alerts the BGM10 to the inoperability and direction for finding the closest BGM in use in the network, in either textual or visual form. The selector button 70 may turn BGM10 on or off so that the user may select from a menu of displayed options, as well as receive commands from the user. A test reader 72 and an optical reader 74 (e.g., for bar codes, handwriting recognition, pattern recognition, optical character recognition, optical indicia recognition, and combinations thereof) (fig. 1A) are used as part of the input data required to test the glucose level of the patient. The speaker 76 may, for example, deliver an alarm that signals that the BGM10 is not properly placed in the base unit, or may convey verbal instructions on how to use the BGM10 or the base unit 12.

Returning to fig. 3, the base unit 12 also includes an output element 80 that is a redundant component of the input-output element 66 on the BGM 10. In other words, the output element 80 of the base unit 12 may convey the same state information as the output element 66 of the BGM 10. The output element 80 can also transfer the BU state information in a manner different from that of the BGM 10. The base unit 12 may, for example, employ a simplified visual indication system 82 (fig. 1A), while the BGM output element 66 may be more specifically directed to the nature of any problem. The visual indication system 82 may, for example, include a Light Emitting Diode (LED) that illuminates or dims to convey status information. The visual indication system 82 may indicate, for example, whether the base unit 12 is in good working order, whether the network connection is good, whether the port connection is good, whether data is being transmitted or received via the port connection and the network connection, and whether the base unit requires maintenance.

The BGM10 and base unit 12 may be part of a networked system 84 of handheld medical devices 86 and their associated base units 88, where in one embodiment the devices 86 and base units 88 are other BGMs 10 and base units 12. In one embodiment, the state information communicated by the BGM10 and the base unit 12 may include state information related to the networked system 84. Other devices 86 may communicate with the remote station 32 via the network 34. In particular, the remote station 32 may receive status information from the BGM10 and the devices 86 regarding the particular devices and associated base units in the system 84. The remote station 32 may also transmit queries and updates to any or all of the devices 10, 86 in the system 84.

The remote station 32 provides a central point for monitoring, collecting and aggregating status information about these devices and their associated base units in the system 84. The remote station 32 may summarize the aggregated status information and then present the status information via the input-output device 90. Input/output devices 90 may include one or more display screens, keyboards, audible alarms, LEDs, LCDs, printers, touch screens, pointing devices, etc. Input/output device 90 may also include a communication device 91 configured to establish a communication link with another person or device not shown in fig. 3.

For example, when the status information from the device 10 or 86 indicates a problem requiring a professional service call, the remote station 32 will automatically summon the service provider by the input/output device 90. Further, when the remote station 32 analysis of the status information received from the device 10 or 86 indicates that the version of software or firmware used by the device and/or associated base unit requires an update, the remote station 32 may automatically transmit the required update to the device via the input/output device 90 and the network 34. The remote station 32 may also store information about the status of the system 84, or any of the devices 10, 86 or base units 12, 88 in the system 84, in the memory 92. The information stored in the memory 92 includes, for example, program status information, software and firmware version numbers, data regarding repair history, and tracking data indicating the location and use of the devices 10, 86 and base units 12, 88.

In one exemplary embodiment, a personal computer is employed as the remote station 32 having an input/output device 90, a communication device 91, and a memory 92. In another exemplary embodiment, a portable device such as a cell phone, pager, or Personal Digital Assistant (PDA) is used as the input/output device 90, where the remote station 32 and memory 92 are located at different physical locations. In this embodiment, the remote station 32 and the input/output device 90 may communicate via a communication link, such as a wireless link or a telephone line, as well as via the communication device 91. The remote station 32 and the input/output device 90 may also communicate via the network 34.

A person in charge, such as a network administrator, may view the status of any of the devices 10, 86 or base units 12, 88 by viewing the input/output device 90. The input/output device 90 may notify the principal that all of the devices 10, 86 and base units 12, 88 in the system 84 are operational, or may notify the principal when attention needs to be paid to the devices or base units in the system 84, for example. When attention is required by a device 10, 86 or base unit 12, 88 in the system 84, the input/output device 90 presents information to the responsible person, such as the location of the device requiring attention and the nature of the problem. Input/output device 90 may also present status information received from devices 10, 86 to a responsible person in response to interrogation by remote system 32. The input/output device 90 may also present data stored in the memory 92, such as a repair history for the device of interest, to a responsible person.

Fig. 4-6 are flow diagrams of embodiments of the system 100 in which an electronic device or remote station interrogates and receives status information from a handheld medical device and a base unit, as well as provides updates. The system 100, electronic device, remote station, handheld medical device, and base unit may be, but are not limited to, the embodiments described in fig. 1-3.

In the embodiment of the system 100 shown in FIG. 4, the requesting unit 102, which may be the electronic device 30, the remote station 32, or the device 86, is in two-way communication with the handheld medical device 104 via the base unit 106. In operation, a query 108 for status information is transmitted from the requesting unit 102 to the handheld medical device 104 in step 110. In step 112, the base unit 106 communicates a query to the handheld medical device 104, which is received in step 114. In step 116, the handheld medical device 104 transmits the device data 62 (e.g., a device log or any other type of data logging and reporting method) to the requesting unit 102, which is communicated by the base unit 106 in step 118.

In step 120, the requesting unit 102 receives the device data 62, processes the status information contained therein to see if there is an alarm or use condition (servicecondition) that requires the responsible person to physically focus on the responding handheld medical device 104 in step 122. If such an alarm or use condition exists, the requesting unit 102 sends a message to another device indicating the alarm or use condition and the location of the handheld medical device 104 in step 124. Further, such information may be presented locally, such as via input/output device 90 (FIG. 3) in step 126. If there is no alarm or use condition, the requesting unit 102 checks to see if an update to the software or firmware of the handheld medical device 104 is required in step 128. If no update is required, the status information is presented locally on the requesting unit 102, e.g., via the input/output device 90 (FIG. 3), in step 130. If an update is required, the update is transmitted from the requesting unit 102 to the handheld medical device 104 in step 132. In step 134, the base unit 106 communicates the update to the handheld medical device 104.

After receiving the update at step 136, the handheld medical device 104 performs a self-diagnostic procedure, such as procedure 60 (FIG. 3), at step 138 to apply the update and obtain new status information. In step 140, the handheld medical device 104 updates the device data with the newly acquired status information. The handheld medical device 104 then repeats step 116 to communicate device data to the requesting unit 102 via the base unit 106. The requesting unit 102 then repeats at least step 128 to determine whether the remaining above process steps need to be repeated. At step 142, status information from the updated device data is presented on the handheld medical device 104 (e.g., via the user interface 54 (FIG. 3)).

The handheld medical device 104 may also communicate status information of the base unit 106 to the requesting unit 102. However, it should be understood that neither the electronic device 30 nor the remote station 32 (FIG. 3) directly interrogate the base unit 106 for status information in the system 84. Instead, as shown in FIG. 5, the handheld medical device 104 queries the base unit 106 for status information in step 200. When so commanded, for example, by a user of the handheld medical device 104 via the user interface 54 (fig. 3), or upon a triggering event (e.g., power on, change in operating conditions) or after a specified period of time, the query 201 from the handheld medical device 104 in step 200 may be initiated as part of a diagnostic procedure, such as performed in step 138 (fig. 4).

After the base unit 106 receives the query in step 202, a diagnostic routine, such as routine 64 (FIG. 3), is executed by the base unit in step 204. The base unit 106 then transmits BU status information to the handheld medical device 104 in step 206, which is received in step 208. In step 210, the handheld medical device 104 processes the status information received in step 208 to see if there is an alarm or use case that requires the responsible person to physically focus on the base unit 106. If such an alarm or use condition exists, the handheld medical device 104 sends a message to another device, such as the remote station 32 (FIG. 3), indicating the alarm or use condition and the location of the base unit 106 in step 212. For example, if a network connection is still available, such a message is communicated from the handheld medical device 104 to a designated unit, such as the requesting unit 102, via the base unit 106 at step 214, received at step 216, and displayed locally on the requesting unit 102 at step 218. In step 220, the requesting unit 102 may send another message to the designated responsible person(s), for example via the communication device 91 or the network 34 (FIG. 3), the message relating to the alert or the use case.

Further, in step 222, such an alert or service message may be presented locally on the handheld medical device 104 via, for example, the input/output device 68 (FIG. 2). In embodiments where the base unit has a visual indicator, such as status indicator 82 (fig. 1A), the base unit 106 checks to see if an alarm or use condition exists in step 224, and if so, provides an indication of the alarm or use condition, such as via the status indicator 82, in step 226.

In step 228, the handheld medical device 104 checks to see if the software or firmware of the base unit 106 needs to be updated. If no update is required, in step 230, the device data is updated with the received BU state information, which may be presented locally, for example, by the input/output device 90 (fig. 3), in step 232. If an update is required, the update is transferred from the memory of the handheld medical device 104 to the base unit 106 in step 234. In step 236, the base unit 106 receives the update. After receiving the update, the base unit 106 performs a self-diagnostic routine described in step 204, such as routine 64 (FIG. 3), to apply the update and obtain new status information, and the remaining steps are repeated after the above-described steps. In one embodiment, the update includes programming the base unit 106 with the network settings requested and transmitted by the handheld medical device 104.

In another embodiment shown in FIG. 6, a requesting unit 102, such as a remote station 32 (FIG. 3), can issue a software or firmware update to a base unit 106 in the system 100. In this embodiment, the requesting unit 102 sends an update in step 302, which is communicated via the base unit 106 in step 304 and received by the handheld medical device 104 in step 306. In step 308, the handheld medical device 104 for receiving buffers the update in memory. In step 310, the handheld medical device 104 transmits the update at the appropriate time. It should be appreciated that the appropriate time may be based on a triggering event, such as step 226 (fig. 5), or determined by a user operating handheld medical device 104.

Next, the handheld medical device 104 adds information (e.g., a protocol header) to the data stream 300 containing the update in step 312 before sending the update to the base unit 106. It will be appreciated that the addition of information (e.g. preceding protocol headers) allows the base unit 106 to recognise that it should not ignore the content of the data stream following the protocol headers, but rather treat it as an upgrade. Otherwise, when no additional information, such as a protocol header, is provided in the data stream, the base unit 106 ignores the contents of the data stream 300 as is all communications between the network device and the handheld medical device 104. For example, in step 314, a protocol header and update is sent from the handheld medical device 104 to the base unit 106, and in step 316, the base unit 106 checks the data stream 300 to see if there is a protocol header. If no protocol header is detected, the data stream is passed to the network for processing in step 318. However, in this example, after detecting the protocol header in the data stream 300, the base unit 106 then applies the update in step 320, such as by executing a diagnostic program, such as program 204 (FIG. 5). Other steps, such as those described with respect to the embodiment of the system shown in fig. 5 after step 204, may also be performed to update the device data and display status information locally on the handheld medical device 104 to indicate that the update has been successfully applied.

Various embodiments of the present invention have been described. These specific examples are intended to illustrate the practical application of the invention. Many modifications are possible without departing from the scope as defined in the claims. For example, the present invention is not limited to a blood glucose meter and its associated base unit, but may be applied to a variety of medical devices. The present invention is not limited to systems in which the medical device or base unit is arranged in a fixed position. In some cases it may be advantageous to arrange the BGM and base unit on a mobile platform, such as an ambulance or a motor vehicle for security use. Furthermore, the present invention includes embodiments in which the remote station is a mobile remote station.

Various examples of communication techniques for communicating between a medical device, a base unit, and a remote station are described. The present invention is not limited to the above-described technique. The communication may also be based on an optical communication link, a magnetic communication link, an infrared communication link, or a visual state change detector. Also, several radio frequency communication links have been described, but the invention is not limited to the above-described techniques. For example, the cellular telephone link may employ any of a number of recognized communication protocols, such as code division multiple access protocol (CDMA), global system for mobile communications (GSM), or General Packet Radio Service (GPRS).

Further, the invention includes software for performing the described techniques. The invention may be implemented as a computer readable medium comprising instructions for causing a programmable processor to perform the above-described method. "computer-readable media" includes but is not limited to read-only memory, flash memory, and magnetic or optical storage media. The instructions may be implemented as one or more software modules, which may be executed by themselves or in combination with other software.

The instructions and media need not be associated with any particular computer or other apparatus, but may be executed by various general-purpose or special-purpose machines. The instructions may be distributed among two or more media and may be executed by two or more machines. The machines may be coupled directly to each other or via a network.

The invention may also be implemented as one or more devices comprising logic circuitry to perform the functions or methods described above. The logic circuit may include a processor, which may be a general purpose programmable processor, or may be a special purpose processor, such as a microcontroller, microprocessor, Digital Signal Processor (DSP), Application Specific Integrated Circuit (ASIC), or the like.

The above description and drawings are only for the purpose of illustrating exemplary embodiments in order to achieve the features and advantages of the present invention. Changes and substitutions to specific process steps, systems, and arrangements can be made without departing from the spirit and scope of the invention. Accordingly, the invention is not limited by the foregoing description and drawings, but is only limited by the scope of the appended claims.

Claims (81)

1. A method of manipulating and managing a base unit of a handheld medical device, comprising:

providing a handheld medical device;

providing a base unit in communication with the handheld medical device, the base unit configured to provide an electrical connection to a power source for charging a battery of the handheld medical device; and

performing an update to the operation of the base unit, wherein the update is initiated by the base unit upon receiving a data stream from the handheld medical device, the data stream having information indicating that the update is contained in the data stream.

2. The method of claim 1, further comprising receiving, by the handheld medical device, the update via the base unit.

3. The method of claim 1, further comprising receiving, by the handheld medical device via the base unit, the update, wherein the update is ignored by the base unit and sent back to the base unit in the data stream from the handheld medical device with information indicating that the update is contained in the data stream to which the handheld medical device added.

4. The method of claim 1, wherein the updating is performed as part of a self-diagnostic test performed in response to a change in the operating condition of the base unit.

5. The method of claim 1, wherein the updating is performed as part of a self-diagnostic test that also evaluates the status information of the base unit and identifies user-operable events and events requiring professional service calls.

6. The method of claim 1, wherein the updating is performed as part of a self-diagnostic test that also communicates status information about the base unit to the handheld medical device.

7. The method of claim 1, further comprising executing a command entered by a user via a handheld medical device.

8. The method of claim 1, further comprising executing commands entered by a user via the handheld medical device, wherein the commands include adjusting configuration settings of the base unit, reporting usage events of the base unit, serial information of the base unit, and receiving location information.

9. The method of claim 1, further comprising transmitting base unit status information to the handheld medical device, wherein the base unit status information includes at least one of: data indicating that the base unit is in good working order, data indicating that the base unit is malfunctioning or potentially having a problem, data indicating the serial number of the base unit, data indicating the physical location of the base unit, data indicating the communication settings of the base unit, data indicating the number of installation events for which usage/wear measurements are made, and data indicating the current software and/or firmware version of the base unit.

10. The method of claim 1, further comprising transmitting base unit status information to the handheld medical device, wherein the base unit status information includes data representing communication settings of the base unit, wherein the communication settings include a definition of a static IP address of the base unit, a definition of an IP subnet mask of the base unit, and definitions of timeouts and various other parameters affecting host communication of the base unit.

11. The method of claim 1, further comprising transmitting base unit status information to the handheld medical device, wherein the base unit status information is recorded in a data file of the handheld medical device.

12. The method of claim 1, wherein the handheld medical device has a user interface including a touch screen display, selector buttons, a test reader, an optical reader, a speaker, a microphone, and combinations thereof.

13. The method of claim 1, wherein the handheld medical device has an option to present the display rotated 180 degrees on the display.

14. The method of claim 1, wherein the base unit includes an output element, and the method further comprises displaying an operational status of the base unit on the output element.

15. A method of manipulating and managing a base unit of a handheld medical device, comprising:

providing a base unit;

a handheld medical device providing communication and an electrical interface with the base unit;

receiving, with the handheld medical device, an update provided via the base unit, the update being ignored by the base unit;

communicating the update from the handheld medical device to the base unit in a data stream, the handheld medical device adding additional information to the data stream; and

receiving the data stream with the base unit, wherein the base unit does not ignore the update due to the detection of the additional information.

16. The method of claim 15, further comprising connecting the base unit to a communication network and receiving updates from the communication network.

17. The method of claim 15, wherein the handheld medical device is in wireless communication with the base unit.

18. The method of claim 15, wherein the handheld medical device communicates with the base unit via a physical connection.

19. The method of claim 15, wherein the handheld medical device and the base unit communicate via a combination of wireless and physical communication links.

20. The method of claim 15, further comprising providing two-way communication between the handheld medical device and at least one of: an electronic device directly connected to the base unit and a remote station connected to the base unit via a network, wherein the update is provided from at least one of the electronic device and the remote station.

21. The method of claim 15, further comprising providing two-way communication between the handheld medical device and at least one of: an electronic device directly connected to the base unit and a remote station connected to the base unit via a network, wherein the update is provided from at least one of the electronic device and the remote station, and wherein the electronic device and the remote station are at least one of: computers, laptop computers, pagers, personal digital assistants, computer servers, printers, mobile phones, and any medical or electronic device having an embedded microprocessor running software compatible with the handheld medical device and base unit and communicating with the base unit.

22. The method of claim 15, further comprising providing two-way communication between the handheld medical device and at least one of: an electronic device directly connected to the base unit and a remote station connected to the base unit via a network, wherein the update is provided from at least one of the electronic device and the remote station, and wherein the network is at least one of: public switched telephone networks, cellular telephone networks, local area networks, wide area networks, global computer networks, integrated services digital networks, private security networks, and private build maintenance networks.

23. The method of claim 15, further comprising providing two-way communication between the handheld medical device and at least one of: an electronic device directly connected to the base unit and a remote station connected to the base unit via a network, wherein the updates are provided from at least one of the electronic device and the remote station, and wherein the network comprises a hardwired electrical, optical communication link, a wireless link, and combinations thereof.

24. The method of claim 15, wherein the handheld medical device and the base unit are electrically interfaced through an electrical connection, the electrical connection being at least one of a physical connection and an inductive coupling.

25. The method of claim 15, further comprising performing a self-diagnostic procedure on the handheld medical device and obtaining status information related to performing the self-diagnostic procedure.

26. The method of claim 15, further comprising performing a self-diagnostic procedure on the handheld medical device, and obtaining status information related to performing the self-diagnostic procedure, wherein the status information relates to at least one of: data indicative of an operational state of the handheld medical device, data indicative of the handheld medical device being in a good working condition, data indicative of a malfunction or potential problem with the handheld medical device, data indicative of a low battery, data indicative of a battery being unable to hold a charge, data indicative of a serial number of the handheld medical device, data indicative of a physical location of the handheld medical device, data indicative of a communication setting of the handheld medical device, data indicative of a current software and firmware version, data indicative of a static IP address of the handheld medical device, data indicative of an IP subnet mask of the handheld medical device, and data indicative of a timeout and various other parameters affecting communication of the handheld medical device.

27. The method of claim 15, further comprising performing a self-diagnostic procedure on the handheld medical device, wherein the self-diagnostic procedure is routinely performed by a microprocessor included with the handheld medical device due to the occurrence of a triggering event, the triggering event being at least one of: the method includes powering on the handheld medical device, removing the handheld medical device from the base unit, placing the handheld medical device to the base unit, receiving a query from another electronic device via the base unit, upon a user request via a user interface command of the handheld medical device, and when a change in an operating condition of the handheld medical device occurs.

28. The method of claim 15, further comprising performing a self-diagnostic procedure on the handheld medical device and obtaining status information related to performing the self-diagnostic procedure, wherein the self-diagnostic procedure evaluates the status information and identifies user-actionable events and events requiring professional service calls.

29. The method of claim 15, further comprising performing a self-diagnostic procedure on the handheld medical device, and obtaining status information relating to the performance of the self-diagnostic procedure, wherein the status information from the self-diagnostic procedure is stored in a data file that is saved in a memory of the handheld medical device, and wherein the handheld medical device is configured to present at least some of the status information via a user interface.

30. The method of claim 15, further comprising performing a self-diagnostic procedure on the handheld medical device and acquiring status information relating to performing the self-diagnostic procedure and providing at least some of the status information to a requesting unit via the base unit.

31. The method of claim 15, further comprising performing a self-diagnostic procedure on the handheld medical device and acquiring status information of the handheld device and the base unit related to performing the self-diagnostic procedure and providing at least some of the status information via the base unit to a requesting unit in communication with the base unit.

32. The method of claim 15, further comprising the handheld medical device interrogating a base unit for status information and obtaining status information from the base unit related to the interrogating base unit.

33. The method of claim 15, wherein the base unit includes a microcontroller that monitors and manages the supply of power from the power source to the battery terminals, and the method further comprises disconnecting the power source when the base unit detects a power source fault condition.

34. The method of claim 15, further comprising sending a query from the handheld medical device, the base unit performing a self-diagnostic test upon receiving the query from the handheld medical device, the self-diagnostic test providing status information to the handheld medical device.

35. The method of claim 15, further comprising sending a query from a requesting unit in communication with the handheld medical device via the base unit, the handheld medical device performing a self-diagnostic test upon receiving the query from the requesting unit, the self-diagnostic test providing status information to the requesting unit.

36. The method of claim 15, further comprising: sending a query from a requesting unit in communication with a handheld medical device via a base unit, the handheld medical device performing a self-diagnostic test upon receiving the query from the requesting unit, the self-diagnostic test providing status information to the requesting unit; and sending an update from the requesting unit to the handheld medical device based on data contained in the status information.

37. The method of claim 15, further comprising sending a query from a requesting unit in communication with the handheld medical device via the base unit, the handheld medical device performing a self-diagnostic test upon receiving the query from the requesting unit, the self-diagnostic test providing status information to the requesting unit, wherein the requesting unit provides a central point for monitoring, collecting, and aggregating status information relating to a network of a plurality of handheld medical devices and their associated base units.

38. A method for manipulating and managing a system, the method comprising:

providing a request unit in two-way communication with the handheld medical device via the base unit;

transmitting a query from the requesting unit to query device data from the handheld medical device;

communicating the query to the handheld medical device via the base unit;

transmitting device data from the handheld medical device to the requesting unit via the base unit, the device data including status information relating to the handheld medical device and the base unit;

checking the status information to see if an update to the software or firmware of the handheld medical device or the base unit is required; and

updates are sent from the requesting unit to the handheld medical device via the base unit when needed.

39. The method of claim 38, further comprising performing a self-diagnostic routine after receiving the update to apply the update and to obtain new status information; and updating the device data with the newly acquired status information.

40. The method of claim 38, further comprising performing a self-diagnostic routine after receiving the update to apply the update and to obtain new status information; updating the device data with the newly acquired state information; and sending the updated device data to the requesting unit; and determining whether the update needs to be repeatedly transmitted according to the updated device data.

41. The method of claim 38, wherein the requesting unit provides a central point for monitoring, collecting, and aggregating status information relating to a network of a plurality of handheld medical devices and their associated base units.

42. The method of claim 38, further comprising communicating updated device data containing the newly acquired status information to the requesting unit via the base unit after applying the update.

43. The method of claim 38, further comprising communicating updated device data containing the newly acquired status information to the requesting unit via the base unit; and determining whether the update needs to be repeatedly transmitted according to the updated device data.

44. The method of claim 38, further comprising providing at least some of the status information to an output device.

45. The method according to claim 38, further comprising processing the status information to see if an alarm or use condition exists, wherein if such an alarm or use condition exists, sending a message to another device indicating the alarm or use condition and the location of the handheld medical device.

46. The method of claim 38, further comprising sending a second query from the handheld medical device to the base unit to query base unit status information.

47. The method of claim 38, further comprising transmitting a second query from the handheld medical device to the base unit to query the base unit for base unit status information, wherein the step of transmitting the second query is initiated based on a triggering event, the triggering event being at least one of: the method includes running a self-diagnostic program of the handheld medical device, commanding the handheld medical device by a user of the handheld medical device through a user interface, energizing the handheld medical device, detecting a change in the operating condition of the base unit, and after a specified period of time has elapsed.

48. The method of claim 38, further comprising performing a self-diagnostic routine to apply the update and obtain new status information after receiving the update; updating the device data with the newly acquired state information; and sending a second query from the handheld medical device to the base unit to query the base unit for base unit status information, wherein the base unit performs the diagnostic procedure after receiving the second query and then communicates the base unit status information to the handheld medical device.

49. The method of claim 38, further comprising sending a second query from the handheld medical device to the base unit to query base unit status information; and receiving the base unit status information, wherein the handheld medical device processes the base unit status information to see if an alarm or a use condition exists.

50. The method of claim 38, further comprising sending a second query from the handheld medical device to the base unit to query base unit status information; and receiving the base unit status information, wherein the handheld medical device processes the status information from the base unit to see if an alarm or use condition exists, and wherein if an alarm or use condition exists, the handheld medical device sends a message to another device, the message indicating the alarm or use condition.

51. The method of claim 38, further comprising sending a second query from the handheld medical device to the base unit to query base unit status information; and receiving the base unit status information, wherein the handheld medical device processes the base unit status information to see if an alarm or use condition exists, and wherein if an alarm or use condition exists, a message is presented on the handheld medical device.

52. The method of claim 38, further comprising sending a second query from the handheld medical device to the base unit to query base unit status information; and receiving the base unit status information; a check is made to see if a base unit update is required to the base unit's software or firmware and, if so, the base unit update is transferred from the handheld medical device to the base unit.

53. The method of claim 38, further comprising transferring a base unit update from the handheld medical device to the base unit.

54. The method of claim 38, further comprising transmitting a base unit update from the handheld medical device to the base unit, wherein after receiving the base unit update, the base unit again performs the self-diagnostic procedure to apply the update and obtain new status information.

55. The method of claim 38, further comprising transmitting a base unit update from the handheld medical device to the base unit, wherein the base unit update comprises programming the base unit with desired network settings for the handheld medical device.

56. An apparatus for manipulating and managing a base unit of a handheld medical device, comprising:

a handheld medical device having a microprocessor, a first communication interface, and a battery to power the handheld medical device; and

a base unit having: an electrical connection configured to be powered from a power source to charge a battery of the handheld medical device; a second communication interface configured to communicate with the first communication interface of the handheld medical device; and a microcontroller configured to perform an update to the operation of the base unit, wherein the update is initiated by the base unit upon receiving a data stream from the handheld medical device via the first and second communication interfaces, the data stream having information indicating that the update is contained in the data stream.

57. The apparatus according to claim 56, further comprising a network connected to the base unit, wherein the handheld medical device is in communication with the network through the base unit, and wherein the handheld medical device is configured to receive the update from the network via the base unit.

58. The apparatus according to claim 56, wherein the base unit is configured to execute commands entered by a user via a handheld medical device.

59. The apparatus according to claim 56, wherein the base unit is configured to execute commands entered by a user via the handheld medical device, wherein the commands include adjusting communication settings of the base unit, reporting usage events of the base unit, serial information of the base unit, and accepting location information.

60. The apparatus according to claim 56, wherein the base unit is configured to transmit base unit status information to the handheld medical device upon receiving a query via the second communication interface, wherein the base unit status information includes at least one of: data indicating that the base unit is in good working order, data indicating that the base unit is malfunctioning or potentially having a problem, data indicating the serial number of the base unit, data indicating the physical location of the base unit, data indicating the communication settings of the base unit, data indicating the number of installation events for which usage/wear measurements are made, and data indicating the current software and/or firmware version of the base unit.

61. The apparatus according to claim 56, wherein the base unit is configured to transmit base unit status information to the handheld medical device upon receiving a query via the second communication interface, wherein the base unit status information includes data representing communication settings of the base unit, wherein the communication settings include a definition of a static IP address of the base unit, a definition of an IP subnet mask of the base unit, and definitions of a timeout and various other parameters affecting host communication of the base unit.

62. The apparatus of claim 56, wherein the handheld medical device has a user interface including a touch screen display, selector buttons, a test reader, an optical reader, a speaker, a microphone, and combinations thereof.

63. The apparatus of claim 56, wherein the handheld medical device is a blood glucose meter.

64. The apparatus according to claim 56, wherein the handheld medical device has a touch screen display, and wherein the handheld medical device has an option to present the display rotated 180 degrees on the touch screen display.

65. The apparatus of claim 56, wherein the base unit comprises an output element.

66. The apparatus according to claim 56, wherein the handheld medical device is in wireless communication with the base unit, wherein the first and second communication interfaces are configured to employ radio frequency, capacitive links, inductive links, infrared links, and combinations thereof.

67. The apparatus of claim 56, wherein the handheld medical device is in communication with the base unit via a physical connection.

68. The apparatus according to claim 56, wherein the handheld medical device is in wireless communication with the base unit, wherein the wireless communication protocol employed by the base unit and the handheld medical device comprises at least one of: bluetooth, ieee802.11a, 802.11b, and 802.11g, and any proprietary wireless communication layer in the industrial, scientific, and medical bands, IrDA, serial Ir, and any other optical protocol.

69. The apparatus of claim 56, wherein the electrical connection is a physical connection.

70. The apparatus of claim 56, wherein the electrical connection is a non-physical connection.

71. The apparatus according to claim 56, wherein the base unit comprises a cradle that houses a handheld medical device.

72. The device of claim 56, wherein the base unit comprises a power cord, a port connection, and a network connection.

73. The apparatus of claim 56, wherein the base unit includes a power cord to supply direct current from an alternating line voltage to the base unit.

74. The device of claim 56, wherein the base unit comprises a port connection comprising a USB connection, a firewire connection, a serial connection, a parallel connection, and combinations thereof.

75. The device of claim 56, wherein the base unit comprises an Ethernet connection.

76. The apparatus according to claim 56, further comprising an electronic device directly connected to the base unit and a remote station connected to the base unit via a network, wherein the handheld medical device is configured to receive updates provided from at least one of the electronic device and the remote station.

77. The apparatus according to claim 56, further comprising an electronic device directly connected to the base unit and a remote station connected to the base unit via a network, wherein the handheld medical device is configured to receive updates provided from at least one of the electronic device and the remote station, and wherein the electronic device and the remote station are at least one of: computers, laptop computers, pagers, personal digital assistants, computer servers, printers, mobile phones, and any medical or electronic device having an embedded microprocessor running software compatible with the handheld medical device and base unit and communicating with the base unit.

78. The apparatus according to claim 56, further comprising an electronic device directly connected to the base unit and a remote station connected to the base unit via a network, wherein the handheld medical device is configured to receive updates provided from at least one of the electronic device and the remote station, and wherein the network is at least one of: public switched telephone networks, cellular telephone networks, local area networks, wide area networks, global computer networks, integrated services digital networks, private security networks, and private build maintenance networks.

79. The apparatus according to claim 56, wherein the handheld medical device communicates with the base unit through a combination of wireless and physical communication links via the first and second communication interfaces.

80. The apparatus of claim 56, wherein the base unit comprises a cradle for supporting a handheld medical device, wherein disposing the handheld medical device in the cradle provides an electrical connection between battery terminals of the handheld medical device and the base unit for charging a battery of the handheld medical device.

81. The apparatus according to claim 56, wherein the microcontroller monitoring and managing power supply from the power source to the battery terminals is configured to power down when the microcontroller detects a power failure condition.