Combination communication device and medical device for communicating wirelessly with a remote medical device
An electronic device may selectively disable a bolus advice process according to which the electronic device recommends delivery of a bolus amount of a drug to a body of a user based on a plurality of factors including glucose concentration of the user. The electronic device may include a glucose measuring facility configured to measure glucose concentration of a body fluid sample, and a processor including a memory having instructions stored therein that comprise the bolus advice process. The memory may further have instructions stored therein that are executable by the processor to request a glucose concentration measurement by the glucose measurement facility prior to executing, or as part of, the bolus advice process, and to disable execution of the bolus advice process if a glucose concentration value resulting from the requested glucose concentration measurement is less than a threshold value.
This application is a continuation of PCT/US2008/066262 filed Jun. 9, 2008 which is based on and claims priority to U.S. Provisional Patent Application Ser. No. 60/937,779 and U.S. Provisional Patent Application Ser. No. 60/937,933, both filed Jun. 29, 2007, all applications in this paragraph are hereby incorporated by reference.
FIELDThis disclosure relates generally to electronic devices that may include one or more on-board medical devices, and more specifically to such electronic devices configured to wirelessly communicate with at least on off-board medical device.
BACKGROUNDRemote electronic devices for wirelessly communicating with at least one medical device are known. It is desirable to include on the remote electronic device an on-board medical device, and/or to conduct wireless communications between the remote electronic device and an off-board medical device for the purpose of commanding operation of the off-board medical device with the remote electronic device.
SUMMARYThe present invention may comprise one or more of the features recited in the attached claims, and/or one or more of the following features and combinations thereof. An electronic device is provided for selectively disabling a bolus advice process according to which the electronic device recommends delivery of a bolus amount of a drug to a body of a user based on a plurality of factors including glucose concentration of the user. The electronic device may comprise a glucose measuring facility configured to measure glucose concentration of a body fluid sample, and a processor including a memory having instructions stored therein that comprise the bolus advice process, the memory further having instructions stored therein that are executable by the processor to request a glucose concentration measurement by the glucose measurement facility prior to executing, or as part of, the bolus advice process, and to disable execution of the bolus advice process if a glucose concentration value resulting from the requested glucose concentration measurement is less than a threshold value.
The electronic device may further comprise a display device. The memory may further include instructions stored therein that are executable by the processor to control the display device to display a message indicating that the bolus recommendation glucose concentration value.
The memory may further include instructions stored therein that are executable by the processor to compute a carbohydrate value based on the glucose concentration value resulting from the requested glucose concentration measurement and a target glucose concentration value. The carbohydrate value may correspond to a quantity of carbohydrates required to be taken by the user to increase glucose concentration of the user to the target glucose concentration value.
The memory may further include instructions stored therein that are executable by the processor to control the display device to display the carbohydrate value with instructions to consume carbohydrates in the amount of the carbohydrate value. The threshold value may correspond to a hypoglycemic threshold.
A method of controlling a color display of an electronic device may comprise determining a measured or computed value, determining a display color based on the measured or computed value relative to at least one limit or range, and changing a color of at least a portion of the display to the display color when displaying the measured or computed value or a message identifying the value.
The electronic device may include a medical device that measures an analyte concentration in a liquid sample. The medical device may be a blood glucose meter that measures glucose concentration in blood samples. In this embodiment, determining a display color based on the measured or computed value may comprise determining a display color based on a measured glucose concentration relative to at least a target blood glucose range. For example, determining a display color may comprise selecting a first color if the measured glucose concentration is within the target blood glucose range. Determining a display color may further comprise selecting a second color different from the first color if the measured glucose concentration is between the target blood glucose range and a low blood glucose value. Determining a display color may further comprise selecting a third color different from the first and second colors if the measured glucose concentration is below the low blood glucose value. The method may further comprise controlling the display to display a warning message if the measured blood glucose concentration is below the low blood glucose value. The low blood glucose value may be a hypoglycemic blood glucose threshold. Determining a display color may further comprise selecting a fourth color different from the first color if the measured glucose concentration is between the target blood glucose range and a high blood glucose value. The method may further comprise controlling the display to display a warning message along with the fourth color if the measured blood glucose concentration is below above the high blood glucose value. The high blood glucose value may be a hyperglycemic blood glucose threshold.
Determining a measured or computed value may alternatively or additionally comprise computing a value, or receiving a computed value, of a quantity of a drug to be delivered to a body.
A method of collecting, in an electronic device, time-based event data stored in a medical device may comprise wirelessly sending by the electronic device a request for the time-based event data, wirelessly sending by the medical device time-based event data stored therein since previously wirelessly sending stored time-based event data upon receiving the request for the time-based event data, wirelessly sending by the electronic device an acknowledgement signal upon receiving the time-event based data from the another electronic device, and identifying by the medical device a location in memory of the last item of the time-event based data that was sent to the electronic device upon receiving the acknowledgement signal.
The medical device may be a liquid infusion pump and the time-based event data may be time-based infusion pump event data.
A method is provided for enabling a bolus advice feature of an electronic device according to which the electronic device recommends delivery of a bolus amount of a drug to a body of a user based on a plurality of factors including glucose concentration of the user. The method may comprise disabling the bolus advice feature of the electronic device during manufacture of the electronic device, monitoring one of a flag and a memory location when the electronic device is operable after manufacture thereof, and enabling the bolus advice feature if one of the flag is activated and the memory location includes a device pairing value.
Monitoring one of a flag and a memory location may comprise monitoring a flag. The method may further comprise activating the flag if a predefined password is received by the electronic device. Alternatively or additionally, the method may further comprise activating the flag when the electronic device has been successfully paired with another electronic device. The another electronic device may comprises an ambulatory medical device.
Monitoring one of a flag and a memory location may comprise monitoring a memory location. The method may further comprise storing the device pairing value in the memory location when the electronic device has been successfully paired with another electronic device. The another electronic device may comprise an ambulatory medical device.
A method of maintaining a time and date in an electronic device that communicates wirelessly with an ambulatory medical device may comprise establishing via the electronic device a wireless communication link between the electronic device and the ambulatory medical device, wirelessly sending by the medical device time and date information, corresponding to a calendar date and time of day maintained by the medical device, when the wireless communication link is established, and modifying by the electronic device a calendar date and time of day thereof if the time of day received from the medical device time differs from the time of day of the electronic device by more than a predefined time value.
The electronic device may include a “my data” feature according to which historical records stored within the electronic device may be viewed. Establishing via the electronic device a wireless communication link between the electronic device and the ambulatory medical device may comprise establishing the wireless communication link, if one is not already established, when the electronic device enters the my data feature.
Alternatively or additionally, the electronic device may include a bolus advice feature according to which the electronic device recommends delivery of a bolus amount of a drug to a body of a user based on a plurality of factors including glucose concentration of the user. Establishing via the electronic device a wireless communication link between the electronic device and the ambulatory medical device may comprise establishing the wireless communication link, if one is not already established, when the electronic device enters the bolus advice feature.
Alternatively or additionally, the electronic device may include an on/off switch. Establishing via the electronic device a wireless communication link between the electronic device and the ambulatory medical device may comprise establishing the wireless communication link, if one is not already established, when the on/off switch is detected as transitioning from an off state to an on state.
Alternatively or additionally, a memory unit of the electronic device may have at least one automatic reminder stored therein. Establishing via the electronic device a wireless communication link between the electronic device and the ambulatory medical device may comprise establishing the wireless communication link, if one is not already established, when the at least one automatic reminder powers on the electronic device from an off state.
Alternatively or additionally, the electronic device may include a remote terminal operating mode according to which the electronic device remote controls operation of the ambulatory medical device. Establishing via the electronic device a wireless communication link between the electronic device and the ambulatory medical device may comprise establishing the wireless communication link, if one is not already established, when the electronic device exits the remote terminal operating mode.
For the purposes of promoting an understanding of the principles of the invention, reference will now be made to a number of illustrative embodiments shown in the attached drawings and specific language will be used to describe the same.
The following co-pending patent applications are incorporated herein by reference: PCT Patent Application No. PCT/US2008/066288, entitled APPARATUS AND METHOD FOR REMOTELY CONTROLLING AN AMBULATORY MEDICAL DEVICE; PCT Patent Application No. PCT/US2008/066331, entitled METHOD AND APPARATUS FOR DETERMINING AND DELIVERING A DRUG BOLUS; PCT Patent Application No. PCT/US2008/066267, entitled LIQUID INFUSION PUMP; PCT Patent Application No. PCT/US2008/066299, entitled USER INTERFACE FEATURES FOR AN ELECTRONIC DEVICE; PCT Patent Application No. PCT/US2008/066247, entitled METHOD FOR PAIRING AND AUTHENTICATING ONE OR MORE MEDICAL DEVICES AND ONE OR MORE REMOTE ELECTRONIC DEVICES; PCT Patent Application No. PCT/US2008/066248, entitled DEVICE AND METHODS FOR OPTIMIZING COMMUNICATIONS BETWEEN A MEDICAL DEVICE AND A REMOTE ELECTRONIC DEVICE; and U.S. Provisional Patent Application Ser. No. 61/130,855, entitled DEVICE AND METHODS FOR OPTIMIZING COMMUNICATIONS BETWEEN AN ELECTRONIC DEVICE AND A MEDICAL DEVICE.
Referring now to
The electronic device 12 further includes a carrier port 20 that extends into the housing from an opening defined therein. The carrier port 20 is sized to receive therein a sample carrier or strip 22 upon which a liquid sample containing an analyte has been or will be deposited. The electronic device 12 includes electrical circuitry that analyzes the liquid sample deposited on the sample carrier 22, when the sample carrier 22 is received within the carrier port 20, to determine a concentration of the analyte contained in the liquid sample. In one embodiment, the liquid sample is blood and the analyte is glucose. In this embodiment, the sample carrier 22 may is illustratively provided in the form of a glucose test strip, and the electrical circuitry of the electronic device 12 includes conventional circuitry that measures the concentration of glucose in a blood sample deposited on the test strip 22. In alternative embodiments, the liquid sample may be or include other bodily fluids, and the analyte may be any analyte that is contained in a bodily fluid.
In the embodiment illustrated in
It will be understood that while the carrier port 20, sample carrier 22 and electrical circuitry of the electronic device 12 have been described in one embodiment as being configured to measure the glucose concentration of blood samples deposited on the sample carrier 22, this disclosure contemplates other embodiments in which the carrier port 20, sample carrier 22 and/or electrical circuitry of the electronic device 12 is/are configured to measure other analytes in other liquid samples.
The medical device 14 includes a conventional processor 28 that is electrically connected to a wireless communication circuit 30. The processor 28 includes a conventional memory unit 25 which has stored therein a number of processes in the form of instructions that are executable by the processor 28 to control operation of the medical device 14 and to wirelessly communicate with the electronic device 12. In the illustrated embodiment, the medical device 14 further includes conventional non-volatile memory units 27 and 29. In one embodiment, the non-volatile memory unit 27 is provided in the form of a conventional ferroelectric random access memory (FRAM) and the non-volatile memory unit 29 is provided in the form of a conventional electrically erasable programmable read only memory (EEPROM), although either memory unit 27, 29 may alternatively be provided in the form of one or more other conventional non-volatile memory units. In any case, the memory units 27 and 29 are each external to the processor 28 and are each electrically connected to the processor 28. In one illustrative embodiment in which the medical device is a drug infusion pump, as will be described in greater detail hereinafter, the memory unit 27 is a pump delivery (PD) memory unit in which the processor 28 stores current pump delivery information, and the memory unit 29 is a pump history (PH) memory unit that has stored therein pump history information, e.g., in the form of event records each corresponding to an operational event of the pump 14. The medical device 14 further includes a wireless communication circuit 30 that is configured to communicate wirelessly with a similar wireless communication module of the remote electronic device 12 via a wireless communication link 40 in a conventional manner. In one embodiment, as will be illustrated by example throughout this disclosure, the wireless communication circuit 30 and the wireless communication module of the electronic device 12 are both conventional BlueTooth® modules configured to wirelessly communicate according to a conventional BlueTooth® communication protocol. It will be understood, however, that the wireless communication circuit or module 30 and the wireless communication module of the electronic device 12 may alternatively be configured to wirelessly communicate according to one or more other communication protocols.
The medical device 14 illustratively includes a housing through which a number of user keys 32 extend. The user keys 32 may be provided in the form of any number of user selectable buttons, keys or switches that are electrically connected to the processor 28. The medical device 14 further includes a visual display unit 34 that is carried by the housing and that is electrically connected to the processor 28. The visual display unit 34 may be, for example, a conventional liquid crystal display (LCD), plasma displays, light emitting diode (LED) based display, vacuum fluorescent (VF) display, or the like. The visual display unit 34 is controlled by the processor 28 to display information to a user of the medical device 14. In alternative embodiments, the user keys 32 may be or include one or more touch-sensitive buttons. In this embodiment, one or more touch-sensitive buttons may, but not, form part of the display unit 34.
The processor 28 of the medical device 14 is further electrically connected to a conventional audible indication device 36 and to a conventional vibratory device 38. The processor 28 is generally operable to control the audible indication device 36 and the vibratory device 38 to produce one or more audible sounds and/or vibrations respectively to notify the user of various operational aspects of the medical device 14 and to also notify the user of any alarm and/or warning conditions associated with the medical device 14. In alternative embodiments, the medical device 14 may not include a display device 34 and/or user keys 32. In some such embodiments, the medical device 14 may include one or more visual indicators for conveying information to a user. Examples of such visual indicators may include, but should not be limited to, one or more lamps, one or more light emitting diodes (LEDs), or the like.
In one illustrative embodiment, the medical device 14 is an ambulatory medical device. Examples of ambulatory medical devices include, but are not limited to, an implantable liquid delivery pump or a non-implantable liquid delivery pump, such as a drug infusion pump, an implantable or non-implantable body condition sensor or sensor system, or the like. In embodiments in which the electronic device 14 is a medication delivery pump, the medication delivered by such a pump may be or include, but should not be limited to, insulin or other conventional blood glucose modifying drug. In alternate embodiments, the liquid delivered by any such a pump may be or include, but should not be limited to, one or a combination of drugs, saline, one or a combination of perfusion fluids, or the like. Throughout this disclosure, the medical device 14 and operations associated with the medical device 14 will be described in the context of an insulin infusion pump, although it will be understood that the medical device 14 may alternatively be or include other medical devices and the following description therefore should not be considered to be limited to an liquid delivery pump generally or to an insulin infusion pump specifically.
Referring now to
The electronic circuit of
As illustrated in
The electronic circuit illustrated in
The memory subsystem 54 temporarily stores data moving between the UI processor 60 and the wireless communication circuit 52. In some embodiments, the memory subsystem 54 does not control other circuitry, and in some such embodiments the memory subsystem 54 may be provided in the form of a conventional memory device. In other embodiments in which the memory subsystem 54 does or does not control other circuitry, the memory subsystem 54 may be provided in the form of a conventional processor that is configured to operate as a Dual-Port RAM (DPR) processor. In such embodiments, the DPR processor 54 operates from a clock signal that is separate from the UI clock signal from which the UI processor 60 operates. In one illustrative embodiment, such a DPR processor 54 is a MC9S08GT16A 8-bit microcontroller unit that is commercially available from Freescale Semiconductor, Inc. of Austin, Tex., although this disclosure contemplates other implementations of the memory subsystem 54 that is provided in the form of a conventional processor configured as a DPR processor 54.
The electronic circuit illustrated in
As illustrated in
As illustrated in
The electronic circuit illustrated in
A dedicated power supply 62 provides a supply voltage, which is also derived from the one or series or parallel combination of rechargeable or non-rechargeable batteries (BATTERY) 60, to the wireless communication module 52. The power supply 62 receives one control input from the user buttons 16, and in the illustrated embodiment the power supply 62 may be powered on and off via one or a combination of the user buttons 16 via the one control input. The power supply 62 also receives another control input from the wireless communication circuit 52, and in the illustrated embodiment the power supply 62 may be turned off by the wireless communication circuit 52 via the other control input.
In addition to the display 18, the UI processor 50 is electrically connected to a conventional audible indication device 72 and also to a conventional vibratory device 74. The UI processor 50 is generally operable to control the audible indication device 72 and the vibratory device 74 to produce one or more audible sounds and/or vibrations respectively to provide for the capability of the device 12 to produce corresponding audible and/or tactile notifications, i.e., alarms or the like. In one embodiment, the audible indication device 72 is a tone generator that produces a beep or other tone when activated, although the audible indication device 72 may alternatively or additionally be or include one or more other conventional audible indication devices.
Generally, the memory subsystem 54 acts as an independent repository of data packets moving between the UI processor 50 and the wireless communication circuit 52. Referring to
In the embodiment illustrated in
The other of the dual ports of the DPR processor 54 is a universal asynchronous receiver/transmitter (UART) port 96 that is electrically connected to a UART port 94 of the wireless communication circuit 52 via a conventional asynchronous interface. Transfer of inbound and outbound data packets between the UART port 94 of the wireless communication circuit 52 and the UART port 96 of the DPR processor 54 (e.g., at 150 kbps) is controlled by the wireless communication circuit 52, and takes place asynchronously with respect to the transfer of inbound and outbound data between the SPI port of the UI processor 50 and the DRP processor 54.
The DPR processor 54 has an inbound data buffer 98 and an outbound data buffer 100 that are each accessible by the SPI and UART ports 92 and 96 respectively of the DPR processor 54. The UART port 96 of the DPR processor 54 includes conventional clear to send (CTS) and ready to send (RTS) lines. The CTS line is monitored by the DPR processor 54 and the RTS line is monitored by the wireless communication circuit 52. The DPR processor 54 deactivates the UART RTS line whenever the inbound data buffer 100 is full, and otherwise activates the UART RTS line. The wireless communication circuit 52 activates the UART CTS line whenever the UART port of the wireless communication circuit 52 is requesting data, and otherwise deactivates the UART CTS line.
When data is to be sent by the UI processor 50 to an external device or system, e.g., the insulin infusion pump 14, the UI processor 50 first requests the state of the outbound data buffer 100 of the DPR processor 54. If the DPR processor 54 answers that its outbound data buffer 100 is “not full,” the UI processor 50 transfers the data, or as much of the data as possible, to the outbound data buffer 100 of the DPR processor 54 via the data out (DO) line of the SPI port 90 at a rate determined by SCLK. If the DPR processor 54 instead answers that the outbound data buffer 100 is “full,” the UI processor 50 waits for a time interval and then repeats the process of requesting the state of the outbound data buffer 100, etc.
Periodically with respect to the clock signal of the wireless communication circuit 52 and asynchronously with respect to the SCLK signal, the wireless communication circuit 52 requests data from the DPR processor 54 by activating the UART CTS line of the DPR processor 54. As long as the outbound data buffer 100 of the DPR processor 54 is empty, the wireless communication circuit 52 continues to periodically activate the UART CTS line. If the UART CTS line is active and the outbound data buffer 100 of the DPR processor 54 is not empty, the wireless communication circuit 52 retrieves the data from the outbound data buffer 100 of the DPR processor 54 via the RX line of the UART port 96. The DPR processor 54 illustratively transfers the data stored in its outbound data buffer 100 to its UART port 96 in a first received to last received order until the outbound data buffer 100 has been emptied or until the wireless communication circuit 52 deactivates the UART CTS line. The wireless communication circuit 52 then incorporates the data retrieved from the outbound data buffer 100 of the DPR processor 52, via the data UART, into to the wireless communication protocol structure, and wirelessly transmits the incorporated data via conventional wireless signal transmission circuitry contained within the wireless communication module 52. The wireless communication circuit 52 does not process, interpret or alter the contents of the data retrieved from the outbound data buffer 100 of the DPR processor 54, nor does it make any decisions or execute any steps based on the contents of the data. Rather, the wireless communication circuit 52 treats all such data the same, regardless of its contents, by incorporating the data into a predefined wireless communication protocol structure, e.g., BlueTooth® protocol structure, and then wirelessly transmitting the incorporated data using the predefined wireless communication protocol. Information transferred by the UI processor 50 to the memory subsystem 54, and then from the memory subsystem 54 to the wireless communication circuit 52 for wireless transmission to another electronic device is thus referred to as outbound information or data.
Inbound wireless signal transmissions from external devices or systems, e.g., the insulin infusion pump 14, are received by the wireless communication circuit 52 via conventional wireless signal receiving circuitry of the wireless communication circuit 52. The wireless communication circuit 52 first isolates the inbound data from the wireless communication protocol structure, and then checks the status of the UART RTS line of the DPR processor 54. If the RTS line is activated, indicating that the inbound data buffer 98 of the DPR processor 54 is not full, the wireless communication circuit 52 sends the isolated data, or as much if the data as possible, to the UART port 96 of the DPR processor 54. The DPR processor 54 then places the data received at the UART port 96 into the inbound data buffer 98 of the DPR processor 54. If the UART RTS line is deactivated, indicating that the inbound data buffer 98 of the DPR processor 54 is full, the wireless communication circuit 52 waits for a time interval before rechecking the state of the UART RTS line.
Periodically, and asynchronously with respect to the operation of the wireless communication circuit 52, the UI processor 50 requests the state of the inbound data buffer 98 of the DPR processor 54 via the data in (DI) line of the SPI port 90. As long as the DPR processor 54 answers that the inbound data buffer 98 is empty, the UI processor 50 continues to periodically request the state of the inbound data buffer 98. If the DPR processor 54 answers that the inbound data buffer 98 of the DPR processor 54 contains data, the UI processor 50 retrieves the data from the inbound data buffer 98 of the DPR processor 52 via the data in (DI) line of the SPI port 90 using the SCLK signal, and then processes the data according to its contents. “Checking” the inbound and/or outbound data buffer 98, 100 of the DPR processor 54 by the wireless communication circuit 52 and/or UI processor 50, as this term may be used hereinafter, will generally refer to the process just described in the preceding several paragraphs. While
The UI processor 50 controls the display 18 of the electronic device 12 to indicate the connection status of the wireless communication module 52 relative to the wireless telemetry system of the insulin infusion pump 14. Upon power up of the electronic device 12, following activation of the power supply 62 via the user buttons 16 after being deactivated and under certain other operating conditions that will be described in greater detail hereinafter, the UI processor 50 attempts to establish a wireless connection with the insulin infusion pump 14. While a wireless connection is not established between the electronic device 12 and the insulin infusion pump 14, the UI processor 50 controls the display 18 to display a flashing (or fixed) icon to indicate that no wireless connection exists between the electronic device 12 and the insulin infusion pump 14. The UI processor 50 independently controls the display 18 in this manner without any information provided by the wireless communication module 52. The UI processor 50 then initiates establishment of a wireless connection between the remote electronic device 12 and the insulin infusion pump 14 by placing a message into the data buffer 100 of the outbound port of the memory subsystem 54, as described above. In this case, the message includes a wireless connection request, e.g., in the form of a command to transmit an acknowledgement response back to the electronic device 12. The wireless communication circuit 52 then transmits this message as described above. If the insulin infusion pump 14 is within range, the insulin infusion pump 14 receives the message and responds to the wireless connection request by wirelessly transmitting a message that includes an acknowledgement response. If the transmitted message is received by the electronic device 12, the wireless communication circuit 52 is operable as described above to isolate the message from the wireless communication protocol structure and to place the message in the data buffer 98 of the inbound port of the memory subsystem 54. The UI processor 50 then retrieves the message from the inbound port of the memory subsystem 54, processes the message to determine whether it contains an acknowledgement response. If the message contains an acknowledgement response, the UI processor 50 interprets this as indicating that a wireless connection is now established between the electronic device 12 and the insulin infusion pump 14, and controls the display device 18 to display a fixed (or flashing) icon to indicate that a wireless connection is established between the electronic device 12 and the insulin infusion pump 14. The electronic device 12 periodically transmits a wireless connection status message to the infusion pump 14 in the above fashion at regular intervals. As long as the insulin infusion pump 14 responds as just described, the UI processor 50 controls the display 18 to display the fixed (or flashing) icon to indicate that a wireless connection exists between the electronic device 12 and the insulin infusion pump 14. If the UI processor 50 does not receive such a response within a predefined time period following storage of the acknowledgement response in the memory subsystem 52, the UI processor 50 controls the display 18 to display a flashing (or fixed) icon indicating that the wireless connection between the electronic device 12 and the insulin infusion pump 14 does not exist or no longer exists.
In the illustrated embodiment the power supply 62 is generally powered on as long as the wireless communication circuit 52 is communicating with either or both of the UI processor 50 or the insulin infusion pump 14, unless otherwise powered off manually by a user via the user buttons 16 or automatically by the wireless communication circuit 52. For example, the power supply 62 may be completely powered down, i.e., turned off, from any state via a simultaneous or sequential user press of a number of the user buttons 16. The power supply 62 remains in the completely powered down state until the user again presses the simultaneous or sequential number of the user buttons 16 or a different simultaneous or sequential user press of a number of the user buttons, or if the user powers down the electronic device 12 and then powers back up the electronic device 12.
While the power supply 62 is on and supplying the supply voltage to the wireless communication circuit 52, the wireless communication circuit 52 is responsive to a number of different events to transition itself into, and out of, any of a plurality of different low power states, and to also turn off the power supply 62 after being in a lowest power sleep state for a predefined time period of inactivity. For example, when in a fully powered “awake” state, the wireless communication circuit 52 is operable to periodically, e.g., every 100-200 milliseconds, check the outbound data buffer 100 of the memory subsystem 54 as described above. As another example, each time the wireless communication circuit 52 finds data to be sent in the outbound data buffer 100 of the memory subsystem 54, the wireless communication circuit 52 incorporates the data into the predetermined wireless communication protocol structure, and wirelessly transmits corresponding signals to the insulin infusion pump 14 as described above. The wireless communication circuit 52 transitions to a first low power state if it fails to find data in the outbound data buffer 100 of the memory subsystem 54 when a predefined time period elapses since last finding data in the outbound data buffer 100. Thereafter, the wireless communication circuit 52 transitions to successively lower power states as successively longer time periods elapse since last finding data in the outbound data buffer 100. The number of different power states generally range between full (100%) power and a lowest power “deep sleep” state, and may include any number of reduced power states between these two extremes. When in the lowest power “deep sleep” state, the wireless communication circuit 52 periodically, e.g., every 400 milliseconds, wakes up to a “UART only” state, in which the wireless communication circuit 52 has sufficient power to check the status of the outbound data buffer 100 of the memory subsystem 54 via the data UART line. If the outbound data buffer 100 of the memory subsystem 54 has data stored therein, the wireless communication circuit 52 wakes up to a full power state to service the data. If the outbound data buffer 100 of the memory subsystem 54 has no data stored therein, the wireless communication circuit 52 transitions back to the lowest power “deep sleep” state. After being in the lowest power sleep state for a predefined period of time of inactivity, the wireless communication circuit 52 sends a control signal to the power supply 62 that causes the power supply 62 to turn off. As a further example, the wireless communication circuit 52 directly monitors activity of the user buttons 16 via the debounce circuitry 68, and when the wireless communication circuit 52 detects user press of the ON button, the wireless communication processor transitions itself from any of the lower power states to the full power state. Thus, in the lowest power “deep sleep” state, the wireless communication circuit 52 must be capable of monitoring at least the ON button of the user buttons 16. Similarly, when the wireless communication circuit 52 detects user press of the OFF button, the wireless communication circuit 52 transitions itself from any of the power states to the lowest power “deep sleep” state.
When a wireless connection is established between the electronic device 12 and the insulin infusion pump 14, and the UI processor 50 determines that the wireless connection should be terminated, the UI processor 50 stores a message in the outbound data buffer 100 of the memory subsystem 54 that contains a connection termination request. When the wireless communication circuit 52 thereafter finds the message in the outbound data buffer 100 of the memory subsystem 54, the wireless communication circuit 52 incorporates the message into the predetermined wireless communication protocol and then transmits the message via its wireless communication circuitry to the insulin infusion pump 14. The insulin infusion pump 14 then wirelessly sends a signal containing a predefined connection termination response back to the remote electronic device 12. Subsequently the processor 28 instructs the wireless communication circuit 30 to orderly terminate communications or connections with the wireless communications circuit 52′ that may be specific to the predetermined wireless communications protocol. When the wireless connection is terminated in this manner, the wireless communication circuit 52 is operable to periodically, but asynchronously with respect to operation of the UI processor 50, check the outbound data buffer 100 of the memory subsystem 54. If no data resides in the outbound data buffer 100, the wireless communication circuit 52 successively enters lower power sleep states or modes as described above. If, however, the wireless communication circuit 52 finds data in the outbound data buffer 100 of the memory subsystem 54, the wireless communication circuit 52 attempts to establish (or re-establish) a wireless connection with the wireless communication circuit 30 of the insulin infusion pump 14 as described above.
If, after a predefined or programmed number of attempts and/or elapsed time, no wireless connection can be established between the wireless communication circuit 52 and the wireless communication circuit 30, the wireless communication circuit 52 illustratively clears the outbound data buffer 100 of the memory subsystem 54. Alternatively, the UI processor 50 may clear the outbound data buffer 100 if it determines that data exists in the outbound data buffer 100 after some time period has elapsed since storing the wireless communication message in the outbound data buffer 100 or after some time period has elapsed after determining, based on failure to receive acknowledgements from the insulin infusion pump 14, that a wireless connection between the remote electronic device 12 and the insulin infusion pump 14 no longer exists. In any case, with the outbound data buffer 100 of the memory subsystem 54 empty, the wireless communication circuit 52 successively enters lower power sleep states or modes as described above.
In the event of a lost wireless connection between the remote electronic device 12 and the insulin infusion pump 14, the wireless communication circuit 52 is operable in one embodiment to turn off its wireless transmission circuitry and to transition to a low power state if it fails to find data in the outbound data buffer 100 of the memory subsystem 54 since last finding data in the outbound data buffer 100. Because the wireless connection is lost, the UI processor 50 will no longer receive acknowledgements from the insulin infusion pump 14 and will therefore cease to store messages in the outbound data buffer 100 of the memory subsystem 54. However, a message, or at least part of a message, may reside within the outbound data buffer 100 when the wireless connection is lost. In this case, after a predefined or programmed number of attempts and/or after a predefined or programmed elapsed time, no wireless connection can be established with the insulin infusion pump 14, the wireless communication circuit 52 illustratively clears the outbound data buffer 100 of the memory subsystem 54. Alternatively, the UI processor 50 may clear the outbound data buffer 100 if it determines that data exists in the outbound data buffer 100 after some time period has elapsed since last storing a message in the outbound data buffer 100 or after some time period has elapsed after determining, based on failure to receive acknowledgements from the insulin infusion pump 14, that a wireless connection between the devices 12 and 14 no longer exists. In any case, with the outbound data buffer 100 of the memory subsystem 54 empty, the wireless communication circuit 52 successively enters lower power sleep states or modes as described above.
In one illustrative embodiment, the UI processor 50 and the processor 28 of the insulin infusion pump 14 may use scheduled messages and internal timers to control determinations by each of whether a wireless connection between the remote electronic device 50 and the insulin infusion pump 14 exists. For example, during information exchange between the electronic device 12 and the insulin infusion pump 14, the UI processor 50 is operable to periodically, e.g., every 100 milliseconds, transfer a message to the outbound data buffer 100 of the memory subsystem 54 and to reset an internal timer circuit. The wireless communication circuit 52 asynchronously retrieves the message from the outbound data buffer 100 of the memory subsystem 54 and transmits the message to the insulin infusion pump 14 as described above. The insulin infusion pump 14 is responsive to receipt of the message to immediately transmit a message back to the electronic device 12 that contains an acknowledgement. The message transmitted by the insulin infusion pump 14 is received and unpacked from the wireless communication protocol by the wireless communication circuit 52, and then stored by the wireless communication circuit 52 in the inbound data buffer 98 of the memory subsystem 54. The UI processor 50 then retrieves the message from the inbound data buffer 98 of the memory subsystem 54 and processes the message to determine whether it contains an acknowledgement. As long as an acknowledgement is received by the UI processor 50 in this manner before the next scheduled transfer of a message to the outbound data buffer 100 of the memory subsystem 54, the UI processor 50 resets its internal timer circuit when transferring the next message to the memory subsystem 54. However, if an acknowledgement is not received by the UI processor 50 before the next scheduled transfer of a message to the outbound data buffer 100 of the memory subsystem 54, the UI processor 50 transfers the message to the outbound data buffer 100 of the memory subsystem 54 without resetting its internal timer circuit. If no acknowledgement is received by the UI processor 50 within a predefined or programmed time period, e.g., 1-2 minutes, the internal timer circuit of the UI processor 50 times out and the UI processor 50 stops transferring messages to the outbound data buffer 100 of the memory subsystem 54. The insulin infusion pump 14, in this embodiment, ceases to send acknowledgements back to the remote electronic device 12 after a predefined or programmed time period, e.g., 2 minutes, has passed without receiving a message transmitted by the electronic device 12.
Illustratively, the UI processor 50 is operable to cease storing messages in the outbound data buffer 100 of the memory subsystem 54 upon detection of insertion of a sample carrier 22 into the carrier port 20 as described above. After a predefined time period in which the wireless communication circuit 52 thereafter fails to find such messages in the outbound data buffer 100 of the memory subsystem 54, the wireless communication circuit 52 begins transitioning to lower power states as described above. When the UI processor 50 then resumes storing messages in the outbound data buffer 100 of the memory subsystem 54 after the analyte measurement is complete, the wireless communication circuit 52 wakes up to full power to service it. This may take at least a wake up time period, e.g., as much as 400 milliseconds, if the wireless communication circuit 52 has just entered the lowest power “deep sleep” state when the first message is stored in the outbound data buffer 100 of the memory subsystem 54 after the analyte measurement is complete.
Unless the remote electronic devices 12 and the insulin infusion pump 14 are communicating information, the wireless communication circuit 52 is generally in one of the lower power sleep states or modes. When insertion of a sample carrier 22 into the carrier port 20 is detected, the electronic device 12 performs an analyte determination test as described above. The electronic device 12 generally does not wirelessly communicate with the insulin infusion pump 14 during the analyte determination test, and the wireless communication circuit 52 is thus typically in one of the lower power sleep states when insertion of the sample carrier 22 into the carrier port 20 is detected. Because the UI processor 50 stops storing messages in the outbound data buffer 100 of the memory subsystem 54 when insertion of the sample carrier 22 into the carrier port 20 is detected, the wireless communication circuit 52 therefore typically enters successively lower power sleep states after insertion of the sample carrier 22 into the carrier port 20 is detected.
While the electronic device 12 is illustrated and described above with respect to
Referring now to
In one embodiment, the process 110 advances from step 112 to step 114 where the UI processor 50 is operable to monitor a predefined password flag. Thereafter at step 116, the UI processor 50 is operable to determine whether the predefined password flag is active. If not, execution of the process 110 loops back to step 114. If; at step 116, the UI processor 50 determines that the predefined password flag is active, the process 110 advances to step 118 where the UI processor 50 is operable to enable the bolus advice feature of the remote electronic device 12. Following step 118, the process 110 ends.
In an alternate embodiment, as illustrated in
In the embodiment illustrated in
Referring now to
The UI processor 50 is operable at step 136 of the process 130 to monitor a number of automatic reminders programmed therein. Thereafter at step 138, the UI processor 50 is operable to determine whether any of the programmed automatic reminders has triggered the power up of the remote electronic device 12 from a powered down state. Alternatively, the UI processor 50 may be operable at steps 136 and 138 to monitor the on/off state of the remote electronic device 12, and to determine whether and when the remote electronic device 12 powers up from a powered down state in response to the occurrence of an automatic reminder. In either case, the “NO” branch of step 138 loops back to step 136, and the “YES” branch of step 138 advances to step 144 where the UI processor 50 is operable to establish a wireless connection with the medical device 14 as described above.
The UI processor 50 is operable at step 140 to monitor the main menu to determine whether the user has selected the bolus advice feature from the main menu (or alternatively from a blood glucose determination menu). If not, the process 130 loops back to the beginning of step 140, and if the UI processor 50 determines at step 140 that a user has selected the bolus advice feature, the process 130 advances to step 144 where the UI processor 50 is operable to establish a wireless connection with the medical device 14 as described above.
The UI processor 50 is operable at 142 to monitor the main menu display on the display device 18 of the remote electronic device 12 to determine whether a user has selected the “my data” feature from the main menu. Illustratively, the “my data” feature corresponds to a data viewing, editing and reporting feature via which a user may view current, historical and trend data relating to operation of the on-board glucose meter and/or the medical device 14. In any case, the “NO” branch at step 142 loops back to the beginning of step 142, and the “YES” branch advances to step 144 where the UI processor 50 is operable to establish wireless connection with the medical device 14 as described above.
Referring now to
At step 150, the UI processor 50 is operable to transfer operating data, e.g., event history information, from the medical device 14 to the remote electronic device 12 via the wireless communication link. In one embodiment, the remote electronic device 12 includes four separate databases that hold history information for computing boluses and for reviewing and/or further analyzing. Referring to
In one illustrative embodiment, the BG/Diary database 65 can hold 1000 records and operates as a circular queue that will over-write the records, oldest first, after the first 1000 records have been accumulated. The BG/Diary database 65 contains the bolus advice calculations and input parameters used in the bolus calculations.
In one embodiment, the correction records (CR) database 71 can hold 150 records and also operates as a circular queue that will over-write the records, oldest first, after the first 150 records have been accumulated. In this embodiment, the CR database 71 is intended to hold 8 hours of prior bolus information. The correction records database 71 is monitored over time by the UI processor 50 to determine which of the records are active and which are inactive. The correction records database 71 is used to determine the amount of active insulin in the body, and uses only the active records to determine this parameter. Each record in the CR database 71 is associated with a specific record in the BG/Diary database, and this association is determined by the BG/Diary date and time stamp and a record counter value of the specific BG/Diary database record. In this example embodiment, the BG/Diary results are stored with a resolution of one minute, and multiple BG/Diary records can be created each minute. Accordingly, the record counter is useful in this embodiment to distinguish between multiple BG/Diary records that may have the same date and time stamp.
In the illustrated embodiment, the meal correction database 69 is a single record database that is updated each time a BG/Diary record with a carbohydrate amount that exceeds a programmable snack size or meal excursion limit is added to the BG/Diary database 65. This update occurs whether the current meal correction record is active or not. Like the correction records database 71, the meal correction database is monitored over time to determine whether the sole record in the meal correction database 69 is or is not currently active. The meal correction record is used when determining the upper BG level that is, in turn, used during the calculation of a correction bolus. The sole record in the meal correction database 69 is also associated with a specific record in the BG/Diary database 65, and this association is determined by the BG/Diary date and time stamp and a record counter value for the specific BG/Diary record.
In the example embodiment, the pump records database 67, like the BG/Diary database 65, can hold 1000 records and also operates as a circular queue that will over-write the records, oldest first, after the first 1000 records have been accumulated. The pump records are received by the pump records database 68 when the operating data from the pump, e.g., the pump history records, are transferred to the remote electronic device 12 according to step 154 of the process 150 of
Referring now to
In any case, the medical device event records are illustratively stored in the data buffer 170 in the order of time of occurrence such that the oldest medical device event record is at the output of the data buffer 170 and the newest medical device event record is at the input of the data buffer 170.
Referring now to
At step 182, the processor 28 of the medical device 14 is operable to determine whether a history gap flag has been set. If so, the process advances to step 184 where the processor 28 includes a history gap indicator in the response to be sent to the remote electronic device 12. The processor 28 is further operable at step 184 to determine from the data buffer 170 whether additional pump history data is available after detecting the history gap from the history gap flag. Illustratively, the processor 28 further includes information in the response to be sent to the remote electronic device 12 that indicates whether any such additional pump history data is available after the detected history gap. From step 184, and from the “NO” branch of step 182, the process advances to step 186 where the processor 28 is operable to send, via the wireless communication circuit 30, a block or partial block of pump history event records to the remote electronic device 12. Thereafter at step 188, the UI processor 50 of the remote electronic device 12 is operable to receive, via the wireless communication circuit 54, the block or partial block of pump history event records from the medical device 14. Thereafter at step 190, the UI processor 50 is operable to determine whether the processing of the block or partial block of pump history event records, e.g., transferring of the pump history event records to the PR database 67, was successful. If not, the process loops back to step 174 where the pump history request, search and transfer process just described is repeated. If, at step 190, the UI processor 50 determines that the processing of the block or partial block of pump history event records at step 188 was successful, the process advances to step 192 where the UI processor 50 is operable to send the wireless communication circuit 54, a successful transfer message to the medical device 14. Thereafter at step 194, the processor 28 of the medical device 14 is operable to receive, via the wireless communication circuit 30, the successful transfer message, and to deactivate or render inactive the history gap flag and set the history position pointer, HP, to a new location in the data buffer 170 that corresponds the oldest pump history event record that was sent to, and successfully processed by, the remote electronic device 12. From step 194, the process loops back to step 176 to again scan pump history event records that were saved in the pump history memory device 29 since storing the pump history event record to which the newly positioned history position pointer, HP, now points.
Step 192 of the illustrated process additionally advances to step 196 where the UI processor 50 is operable to determine whether all pump history event records since the previous execution of the illustrative process have been transferred from the medical device 14 to the remote electronic device 12. Illustratively, the processor 28 of the medical device 14 is operable to include a last record indicator in the block or partial block of pump history event records transferred from the medical device 14 to the remote electronic device 12 at step 184. If, at step 196, the UI processor 50 determines that the last record information was received and processed in the most recent block or partial block of the pump history event records sent from the medical device 14 to the remote electronic device 12, the process advances to step 198 where the process ends. Otherwise, the process loops from step 196 back to step 174 where the process continues as described until all pump history event records that were stored in the memory device 29 of the processor 28 since the previous execution of the illustrated process are transferred.
At step 200, the processor 28 of the medical device 14 is operable to monitor the data in the pump history event record to which the history position pointer, HP, points. Thereafter at step 202, the processor 28 is operable to determine whether the data in the pump history event record to which HP points has changed since the previous transfer of information from the medical device 14 to the remote electronic device 12. If so, this means that at least some of the pump history event records stored in the data buffer 170 have been overwritten since the last transfer of information from the medical device 14 to the remote electronic device 12, and that a gap in the time line of pump history event records therefore exists. In this case, the process advances from step 202 to step 204 where the processor 28 is operable to activate the history gap flag described above. Otherwise, step 202 loops back to step 200.
Referring again to
The pump history records transferred from the pump 14 to the remote electronic device 12 may include commanded and non-commanded pump events. Commanded events are generally those in which the remote electronic device 12 commands the liquid infusion pump 14, via the wireless communication circuits 52 and 30 respectively, to deliver a desired bolus amount and type, except when the remote electronic device 12 and the pump 14 are operating in a remote terminal operating mode as briefly described above. In such cases, the commanded events are treated as being locally commanded, i.e., commanded by pressing appropriate ones of the keys 32 of the pump 14. Non-commanded events, in contrast, are those that were performed manually by the user and not commanded by the remote electronic device 12. Non-commanded events may include manually programming the liquid infusion pump 14 to deliver desired bolus amounts and types, and also manually delivering bolus amounts via a syringe or drug delivery pen. In the process illustrated in
Illustratively, the UI processor 50 is operable pursuant to the process illustrated in
If a pump event record is matched with an existing BG/Diary record, the delivered bolus amount is checked for confirmation. If the delivered amount in the pump event record matches the bolus amount in the matched BG/Diary record, the bolus amount is confirmed and the BG/Diary record is updated to reflect this result. If, on the other hand, the delivered amount in the pump event record is different from the bolus amount in the matched BG/Diary record, the actual delivered amount is confirmed and the BG/Diary record is updated to reflect this result. In this latter case, however, the correction records database 71 is updated to reflect the actual delivered bolus amount. Illustratively, the correction records database 71 is updated in this manner to ensure accuracy of the active insulin value that can be determined from the data.
The process illustrated in
If the UI processor 50 determines at step 214 that the current pump event corresponds to a programmed bolus amount, the illustrated process advances to step 216 where the UI processor 50 searches through the non-confirmed and non-programmed Standard, Extended and Multi-wave bolus type records in the BG/Diary database 65 for a record having a date/time stamp and bolus delivery type (DTD) that matches that of the current pump event record. If the UI microprocessor 50 finds such a match at step 216, the illustrated process advances to step 218 where the UI processor 50 determines whether the time stamp (T) of the matched BG/Diary record is within a predefined time value, e.g., 6 minutes, of that of the current pump event record. If so, the illustrated process advances to step 220 where the UI processor 50 is operable to determine whether the programmed bolus amount in the BG/Diary record is equal to a user selected amount. If so, the illustrated process therefore advances to step 222 where the UI processor 50 is operable to set a bolus advice flag in the current BG/Diary record to PROG. If at step 218 the UI processor 50 determines that the time stamps (T) of the matched BG/Diary record is not within the predefined time value of that of the current pump event record, the illustrated process advances to step 224. Likewise, if the UI processor 50 determines at step 220 that the programmed bolus amount in the BG/Diary record is not equal to a user selected amount, the illustrated process advances to step 224. Also, if the UI processor 50 does not find a match at step 216, the illustrated process advances to step 224. At step 224, the UI processor 50 is operable to create and add a new record to the BG/Diary database 65 using the date/time stamp and data from the current pump event record, and to set a bolus advice flag of this new record to PROG.
If, at step 214, the UI processor 50 determines that the current pump event corresponds to a delivered bolus amount, the illustrated process advances to step 226 were the UI processor 50 is operable to determine whether the bolus delivery type was a standard bolus or either of an extended bolus and a multi-wave bolus. If the UI processor 50 determines at step 226 that the delivered bolus type is a standard bolus (STD), the illustrated process advances to step 228 where the UI processor 50 searches through the non-confirmed and programmed Standard bolus type records in the BG/Diary database 65 for a record having a date/time stamp and bolus delivery type (DTD) that matches that of the current pump event record. If the UI microprocessor 50 finds such a match at step 228, the illustrated process advances to step 230 where the UI processor 50 determines whether the time stamp (T) of the matched BG/Diary record is within a predefined time value, e.g., 6 minutes, of that of the current pump event record. If so, the illustrated process advances to step 232 where the UI processor 50 is operable to update the confirmed bolus amount with the delivered bolus amount from the pump event record and to then set the bolus advice flag to DELIV. If at step 230 the UI processor 50 instead determines that the time stamps (T) of the matched BG/Diary record is not within the predefined time value of that of the current pump event record, or the UI processor 50 does not find a match at step 228, the illustrated process advances to step 234 where the UI processor 50 is operable to create and add a new record to the BG/Diary database 65 using the date/time stamp and data from the current pump event record, and to set a bolus advice flag of this new record to DELIV.
If, at step 226, the UI processor 50 determines from the pump event record that the delivered bolus type is not a standard bolus (STD), the illustrated process advances to step 236 where the UI processor 50 searches through the non-confirmed and programmed Extended (EXT) and Multi-wave (MW) bolus type records in the BG/Diary database 65 for a record having a date/time stamp and bolus delivery type (DTD) that matches that of the current pump event record. If the UI microprocessor 50 finds such a match at step 236, the illustrated process advances to step 238 where the UI processor 50 determines whether the time stamp (T) of the matched BG/Diary record is within a predefined time value, e.g., 6 minutes, of that of the current pump event record. If so, the illustrated process advances to step 240 where the UI processor 50 is operable to update the confirmed bolus amount with the delivered bolus amount from the pump event record and to then set the bolus advice flag to DELIV. If at step 238 the UI processor 50 instead determines that the time stamp (T) of the matched BG/Diary record is not within the predefined time value of that of the current pump event record, or the UI processor 50 does not find a match at step 236, the illustrated process advances to step 242 where the UI processor 50 is operable to create and add a new record to the BG/Diary database 65 using the date/time stamp and data from the current pump event record, and to set a bolus advice flag of this new record to DELIV.
Referring now to
If, at step 250, the UI processor 50 determines from the current pump history record that the pump event type corresponds to a delivered bolus event, the illustrated process advances to step 262 where the UI processor 50 is operable to search through the Manual and Pen/Syringe type, non-confirmed and programmed records in the BG/Diary database 65 for a record having a date/time stamp that matches that of the current pump event record. If the UI microprocessor 50 finds such a match at step 262, the illustrated process advances to step 264 where the UI processor 50 determines whether the time stamp (T) of the matched BG/Diary record is within a predefined time value, e.g., 5 minutes, of that of the current pump event record. If so, the illustrated process advances to step 266 where the UI processor 50 is operable to update the confirmed bolus amount with the delivered bolus amount from the pump event record and to then set the bolus advice flag to DELIV. If at step 262 the UI processor 50 does not find a match, and also from the “NO” branch of step 264, the illustrated process advances to step 268 where the UI processor 50 is operable to create and add a new record to the BG/Diary database 65 using the date/time stamp and data from the current pump event record. Thereafter at step 270, the UI processor 50 is operable to set the bolus advice flag of this new record to DELIV and to set the delivery type to MANUAL.
Further details relating to the processing of information in one or more of the databases 65, 67, 69 and 71 are provided in co-pending PCT Patent Application No. PCT/US2008/066331 and which is assigned to the assignee of this disclosure, and the disclosure of which has been incorporated herein by reference.
Referring again to
The “YES” branch of step 146 also advances to step 168 where the UI processor 50 is operable to check and act on any warnings, alarms or errors that are associated with the medical device 14 and the occurrence of which is communicated wirelessly to the remote electronic device 12 when the wireless communication link is established. Following steps 152, 166 and 168 and the “NO” branch of step 162, the process 145 ends.
Referring now to
Illustratively, the process 300 is stored in the memory device 66 of the UI processor 50 in the form of instructions that are executable by the UI processor 50 to carry out the bolus advice process 300. The process 300 presumes that the remote electronic device 12 is powered up and that the UI processor 50 is currently controlling the display device 18 to display a main menu 302 that is generally displayed upon power up of the remote electronic device 12. Illustratively, the main menu 302 provides for a number of selectable user options that include, but that should not be limited to, a blood glucose (BG) test, a bolus advice process, a pump remote control process 304, a “my data” process 306 and a settings or device set up process. The pump remote control process 304, or remote terminal operational mode as referred to above, illustratively provides a menu-driven process by which the remote electronic device 12 may control operation of the insulin infusion pump 14 substantially in real time. One illustrative embodiment of such a process is described in co-pending PCT Patent Application No. PCT/US2008/066288, which is assigned to the assignee of this disclosure, and the disclosure of which has been incorporated herein by reference.
The “my data” process 306 illustratively provides for the viewing and editing of diary records, e.g., specific BG test records and pump history records, and also for the analysis of the records over daily and/or weekly time periods. Illustratively, the UI processor 50 stores in the memory 66 up to 1,000 diary records, and up to 250 records may be reviewed using the remote electronic device. The diary records may also be downloaded to a PC or other computer, and using compatible software all records may be viewed and/or analyzed. Each diary record may contain date and time, BG test result, meal time events, carbohydrate value, health event, bolus type, bolus amount and duration. The UI processor can filter and/or sort data from these data records.
The “my data” process also provides for the analysis of the data records in the form of daily and weekly averages, and standard deviations, defined by time slot, and for trend analysis of any of the collected data. Standard day and standard week tables or graphs may be generated to view averages and/or trends. Various charting and table options are also available for presenting data in desired formats.
The BG test process that may be selected from the main menu 302 begins at step 308 where the UI processor 50 determines whether the user has selected the BG test process from the main menu 302. If not, the “NO” branch of step 308 loops back to the beginning of step 308. If, at step 308, the UI processor 50 determines that the user has selected the BG process from the main menu 302, the process 300 advances to step 310 where the UI processor 50 controls the display device 18 to prompt a user to conduct a BG test. In one embodiment, the UI processor 50 controls the display device 18 to visually guide a user through a blood glucose measurement sequence in which a user inserts a carrier 22 into the glucose measurement facility 20 of the remote electronic device 12 and deposits a sample of blood on the carrier 22, after which the blood glucose meter 88 analyzes the blood sample in a conventional manner to produce a blood glucose (BG) value that corresponds to a concentration of glucose in the deposited blood sample. The blood glucose value, BG, is provided by the blood glucose meter 88 that is on-board the remote electronic device 12 to the UI processor 50 as describe hereinabove. From step 310, the process 300 advances to step 312 where the UI processor 50 is operable to control the display device 18 to display the BG value along with an on-screen color indicator that is based on the BG value relative to one or more reference BG values.
Referring now to
The process 350 begins at step 352 where the processor 50, 28 is operable to determine whether an analyte or drug related value has just been measured or computed. If not, the “NO” branch of step 352 loops back to the beginning of step 352. Otherwise, the process 350 advances to step 354 where the processor 50, 28 is operable to determine a display color based on the measured or computed value relative to one or more reference values. Thereafter at step 356, the processor 50, 28 is operable to control the display device 18, 34 to change the color of the display or a portion thereof to the display color determined at step 354 when displaying the measured or computed value and/or a warning message related to the measured or computed value. From step 356, the process 350 ends.
The process 350 of
Also following step 310, the process 300 advances to step 314 where the UI processor 50 is operable to execute a hypoglycemic test process in relation to the blood glucose value, BG, measured at step 310. Referring now to
If the process 300 reaches step 316, the BG value display screen illustratively provides a bolus option that a user may select to enter the bolus advice process directly from the BG measurement process. The UI processor 50 is accordingly operable following the ADVANCE path from step 314 to step 316 to determine whether the user has selected the bolus option from the BG display. If not, the process 300 advances to step 318 where the user has pressed another key or has selected another option, or alternatively has done nothing and caused the BG value screen to time out. Generally, the UI processor 50 is operable to store the BG value in the memory unit 66 along with measurement time and date information. Illustratively, the user may also store additional information along with the time and date stamp BG value, examples of which may include, but should not be limited to, the timing of the BG measurement relative to meal, bedtime and/or awake time information, amount of carbohydrates taken at the time of the BG measurement, health information such as exercise level, illness or stress, and the like. In any case, if the UI processor 50 determines at step 316 that the user has selected the bolus key option from the BG value display screen, the process 300 advances to step 322.
From the main menu 302, the user may alternatively select the bolus advice process, and the UI processor 50 is accordingly operable at step 320 to determine if the user has selected the bolus advice process. If not, the “NO” branch step 320 loops back at the beginning of step 320, and otherwise the process 300 advances to step 322 where the UI processor 50 is operable to determine whether the pump history and/or bolus threshold and/or pump status information was updated when the bolus advice process 300 was entered either via step 316 or step 322. If not, the process 300 advances to step 324 where the processor 50 is operable to control the display device 18 to display a warning message on the bolus advice screen that one or more bolus advice values and/or an active insulin may not be based on current drug pump operating history. From step 324, and from the “YES” branch of step 322, the process 300 advances to step 326 where the processor 50 is operable to compute the active insulin value, AI. Thereafter at step 328, the UI processor 50 is operable to compute a first bolus value, B1, which is illustratively based on a recent blood glucose value and also on pump operating history data. In embodiments in which blood glucose has not recently been measured, B1=0. Also at step 328, the UI processor 50 is operable to compute a second bolus value, B2, that is illustratively based on CARB values entered by the user that correspond to carbohydrates that the user has taken or is planning to take. Further at step 328, the UI processor 50 is operable to compute a third bolus value, B3, which is illustratively based on health information entered by the user that corresponds to a current health state of the user. As one illustrative example, the health state of the user may correspond to exercise, stress, illness, or the like. Further details relating to illustrative techniques for computing AI and B1-B3 are provided in co-pending PCT patent application Ser No PCT/US2008/066331, the disclosure of which has been incorporated herein by reference.
The process 300 advances from step 328 to step 330 where the UI processor 50 is operable to compute a total recommended bolus, TRB, as a sum of B1-B3. Thereafter at step 332, the UI processor 50 is operable to control the display unit 18 to display a bolus advice screen that shows the active insulin value, AI, any recent blood glucose value, BG, a BG color indicator as described with respect to step 312, B1-B3, TRB and a bolus type, e.g., standard (STD), multi-wave (MW), extended (EXT), each of which may be used to automatically program the pump 14 from the remote electronic device 12, and two manual types. In one embodiment, if a blood glucose measurement, BG, has been conducted within a predefined time period prior to executing step 332, the UI processor 50 is operable at step 332 to display the bolus advice screen showing the measured blood glucose value, BG. Otherwise, the UI processor 50 may be illustratively operable at step 332 to display “bG Test” on the screen where a BG value would be shown if a current BG value was available. From step 332, the process 300 advances to a sub-process B. In general, any value that was measured by or entered into the remote electronic device 12 or medical device 14 may illustratively be displayed when a screen that includes such a value is displayed if the value was measured or entered within a predefined time period since measuring or entering the value.
Referring now to
An apple symbol is used to identify a carbohydrates field 380, and a heart symbol is used to identify a health field 382. A bolus type indicator 386 appears below the health field 382 and the total recommended bolus value 382, e.g., 3 U, is displayed adjacent to the bolus type indicator 386. A bolus type 388, e.g., Standard, is displayed below the total recommended bolus 384. At the bottom of the screen between Cancel and Confirm inputs, a BlueTooth® symbol 390 is provided to indicate the connection status of the wireless communication link with the insulin infusion pump 14, e.g., solid when a wireless connection exists and otherwise flashing.
Referring now to
The sub-process B of
The sub-process B of
The sub-process B of
Referring now to
Following step 474, the process 470 advances to step 476 where the UI processor 50 is operable to determine whether the user has selected a bolus type. If not, the process 470 loops back to step 474. If the processor 50 determines that the user has, at step 476, selected a bolus type, the process 470 advances to step 476 where the UI processor 50 is operable to control the display device 18 to update the bolus advice display to include the selected bolus type. The process 470 loops from step 478 back to the beginning of the sub-process B.
The sub-process B of
The sub-process B of
It at step 494, the UI processor 50 determines that TRB is not less than or equal to zero, the process 490 advances to step 498 where the UI processor 50 is operable to determine whether the user confirmation detected at step 492 is of a manual, e.g., manual pump or pen/syringe, or commanded, e.g., STD, MW or EXT, bolus. If the user confirmation is of a commanded bolus, the process 490 advances to step 500 where the UI processor 50 is operable to determine whether the remote electronic device 12 and the pump 14 are still wirelessly connected via a wireless communication link 40 (see
If, at step 500, the UI processor 50 determines that the remote electronic device 12 and the pump 14 are still wirelessly connected, the process 490 advances to step 504 the UI processor 50 determines whether the user selected bolus type, i.e., the bolus type selected by the user at step 476, is a Standard bolus, STD. If so, the process 490 advances to a process C. If not, the process 490 advances to step 506 where the UI processor 50 is operable to determine whether the user selected bolus type, i.e., the bolus type selected by the user at step 476, is a multi-wave bolus, MW. If so, the process 490 advances to a process D. If not, the process 490 advances to a process E.
If, at step 498, the UI Processor 50 determines that the user confirmation detected at step 492 is of a manual bolus, the process 490 advances to step 508 where the UI processor 50 is operable to determine whether the confirmed bolus type is a manual pump (MP), corresponding to manually programming an infusion pump to deliver the bolus, or a pen/syringe (PS), corresponding to manual delivery of the bolus via a conventional drug pen or syringe. If the confirmed bolus is a manual pump (MP), the process 490 advances to a process F, and if the confirmed bolus is a pen/syringe (PS), the process 490 advances to a process G.
As described hereinabove with respect to
In such cases, the UI processor 50 is operable at step 522 of the process 300 of
Referring now to
The process 550 advances from the “YES” branch of step 562 to step 564 where the UI processor 50 is operable to send a deliver command to the pump 14 and to store the entire record in memory. Thereafter at step 566, the processor 50 is operable to receive a wireless message from the pump 14 corresponding to an amount of the total programmed bolus that is currently being delivered. The UI processor 50 is, in turn, operable to control the display device 18 to update the total recommended bolus value, TRB, to reflect delivery by the pump 14 of the bolus amount so far delivered. For example, if at step 566 the UI processor 50 receives a message from the pump 14 that the pump 14 has delivered 1/10 U of insulin, the UI processor 50 is operable to control the display device 18 to update the displayed TRB value by subtracting 1/10 U from the displayed value of TRB. Thereafter at step 568, the UI processor 50 is operable to determine whether a user has manually stopped the insulin delivery process by manually selecting a suitable one or more of the user buttons 16 of the remote electronic device 12. If the UI processor 50 determines that the user has manually stopped the delivery of insulin by the pump 14, the process 550 advances to step 570 where UI processor 50 controls the display device 18 to display a bolus canceled message. Otherwise, the process 550 advances to step 572 where the UI processor 50 is operable to determine, based on messages wirelessly provided by the pump 14, whether delivery of the standard bolus is complete. If not, the process 550 loops back up to step 566. Thus, steps 566-572 illustratively result in a count down on the display device 18 of bolus delivery from the total recommended bolus value, TRB. When delivery of the standard bolus is complete, step 572 advances to step 574 where the UI processor 50 is operable to control the display device 18 to display a delivery complete message. From step 574, and also from step 570, the process 550 advances to step 576 where the UI processor 50 stores the bolus delivery record in memory.
Referring now to
If, at step 584, the UI processor 50 determines that the multi-wave bolus program acknowledgement and accompanying programmed bolus data was received, the process 580 advances to step 590 where the UI processor 50 is operable to display a multi-wave bolus confirmation screen with the immediate portion, IMD, the bolus duration, DUR, and the total programmed bolus amount. Thereafter at step 592, the UI processor 50 is operable to determine whether the user has selected a back, i.e., go back, function that is available on the confirmation screen. If so, the process 580 advances to step 594 where the UI processor 50 is operable to return to the previous bolus advice screen. If not, the process 580 advances to step 596 where the UI processor 50 is operable to determine whether the user has selected the IMD field of the multi-wave bolus screen for editing. If so, the process 580 advances to step 598 where the UI processor 50 is operable to determine whether the user has entered a new IMD value in the IMD field of the multi-wave bolus screen. If not, the process 580 loops back to the beginning of step 598. If so, the process 580 loops back to step 590. If, at step 596, the UI processor 50 determines that the user has not selected the IMD field for editing, the process 580 advances to step 600 where the UI processor 50 is operable to determine whether the user has selected the DUR field of the multi-wave bolus screen for editing. If so, the process 580 advances to step 602 where the UI processor 50 is operable to determine whether the user has entered a new DUR value in the DUR field of the multi-wave bolus screen. If not, the process 580 loops back to the beginning of step 602. If so, the process 580 loops back to step 590. If, at step 600, the UI processor 50 determines that the user has not selected the IMD field for editing, the process 580 advances to step 604 where the UI processor 50 is operable to determine whether the user has selected the deliver function of the multi-wave bolus screen. If, at step 606, the UI processor 50 has determined that the user has selected deliver on the multi-wave bolus confirmation screen, the UI processor 50 sends a deliver command to the pump 14 to which the pump is responsive to begin delivering the multi-wave bolus in the amount of the total programmed bolus having an immediate portion, IMD, and a duration, DUR.
The process 580 advances from the “YES” branch of step 604 to step 606 where the UI processor 50 is operable to send a deliver command to the pump 14 and to store the entire bolus advice record in memory. Thereafter at step 608, the UI processor 50 is operable to receive a wireless message from the pump 14 corresponding to an amount of the immediate portion, IMD, of the multi-wave bolus that is currently being delivered. The UI processor 50 is, in turn, operable to control the display device 18 to update the immediate bolus value, IMD, to reflect delivery by the pump 14 of the immediate bolus amount so far delivered. For example, if at step 608 the UI processor 50 receives a message from the pump 14 that the pump 14 has delivered 1/10 U of insulin, the UI processor 50 is operable to control the display device 18 to update the displayed IMD value by subtracting 1/10 U from the displayed value of IMD. Thereafter at step 610, the UI processor 50 is operable to determine whether a user has manually stopped the insulin delivery process by manually selecting a suitable one or more of the user buttons 16 of the remote electronic device 12. If the UI processor 50 determines that the user has manually stopped the delivery of insulin by the pump 14, the process 580 advances to step 612 where UI processor 50 controls the display device 18 to display a bolus canceled message. Otherwise, the process 580 advances to step 614 where the UI processor 50 is operable to determine, based on messages wirelessly provided by the pump 14, whether delivery of the immediate portion of the multi-wave bolus is complete. If not, the process 580 loops back up to step 608. Thus, steps 608-614 illustratively result in a count down on the display device 18 of delivery of the immediate portion of the multi-wave bolus. When delivery of the immediate portion of the multi-wave bolus is complete, step 614 advances to step 616 where the UI processor 50 is operable to control the display device 18 to display an immediate bolus delivery complete message that is followed by or that includes a message that the multi-wave bolus delivery is continuing.
Referring now to
If, at step 624, the UI processor 50 determines that the extended bolus program acknowledgement and accompanying programmed bolus data was received, the process 620 advances to step 630 where the UI processor 50 is operable to display an extended bolus confirmation screen with the bolus duration, DUR, and the total programmed bolus amount. Thereafter at step 632, the UI processor 50 is operable to determine whether the user has selected a back, i.e., go back, function that is available on the confirmation screen. If so, the process 620 advances to step 634 where the UI processor 50 is operable to return to the previous bolus advice screen. If not, the process 620 advances to step 636 where the UI processor 50 is operable to determine whether the user has selected the DUR field of the multi-wave bolus screen for editing. If so, the process 620 advances to step 638 where the UI processor 50 is operable to determine whether the user has entered a new DUR value in the DUR field of the extended bolus screen. If not, the process 620 loops back to the beginning of step 638. If so, the process 620 loops back to step 630. If, at step 636, the UI processor 50 determines that the user has not selected the DUR field for editing, the process 620 advances to step 640 where the UI processor 50 is operable to determine whether the user has selected the deliver function of the multi-wave bolus screen. If, at step 406, the UI processor 50 has determined that the user has selected deliver on the extended bolus confirmation screen, the UI processor 50 sends a deliver command to the pump 14 to which the pump is responsive to begin delivering the extended bolus in the amount of the total programmed bolus having a duration, DUR.
The process 620 advances from the “YES” branch of step 640 to step 642 where the UI processor 50 is operable to send a deliver command to the pump 14 and to store the entire bolus advice record in memory. Thereafter at step 644, the UI processor 50 is operable to receive a wireless message from the pump 14 that the pump is currently delivering the extended bolus. Thereafter at step 646, the UI processor 50 is operable to control the display unit 18 to display a message indicating that delivery of the extended bolus is continuing.
Referring now to
Referring now to
Further details relating to the bolus advice process illustrated in
While the invention has been illustrated and described in detail in the foregoing drawings and description, the same is to be considered as illustrative and not restrictive in character, it being understood that only illustrative embodiments thereof have been shown and described and that all changes and modifications that come within the spirit of the invention are desired to be protected. For example, the UI processor 50 and/or the processor 28 of the medical device may be configured to determine a display color based on a computed and/or delivered bolus value, relative to one or more reference bolus values and to change the color of the display device 18 and/or 34, or portion thereof, to the determined display color, as described above with respect to
Claims
1. An electronic device for selectively disabling a bolus advice process according to which the electronic device recommends delivery of a bolus amount of a drug to a body of a user based on a plurality of factors including glucose concentration of the user, the electronic device comprising:
- a glucose measuring facility configured to measure glucose concentration of a body fluid sample, and
- a processor including a memory having instructions stored therein that comprise the bolus advice process, the memory further having instructions stored therein that are executable by the processor to request a glucose concentration measurement by the glucose measurement facility prior to executing, or as part of, the bolus advice process, and to disable execution of the bolus advice process if a glucose concentration value resulting from the requested glucose concentration measurement is less than a threshold value.
2. The electronic device of claim 1 further comprising a display device,
- and wherein the memory further includes instructions that are executable by the processor to control the display device to display a message indicating that the bolus recommendation glucose concentration value.
3. The electronic device of claim 2 wherein the memory further includes instructions stored therein that are executable by the processor to compute a carbohydrate value based on the glucose concentration value resulting from the requested glucose concentration measurement and a target glucose concentration value, the carbohydrate value corresponding to a quantity of carbohydrates required to be taken by the user to increase glucose concentration of the user to the target glucose concentration value.
4. The electronic device of claim 3 wherein the memory further includes instructions stored therein that are executable by the processor to control the display device to display the carbohydrate value with instructions to consume carbohydrates in the amount of the carbohydrate value,
- and wherein the threshold value corresponds to a hypoglycemic threshold.
5. A method of controlling a color display of an electronic device, the method comprising:
- determining a measured or computed value,
- determining a display color based on the measured or computed value relative to at least one limit or range, and
- changing a color of at least a portion of the display to the display color when displaying the measured or computed value or a message identifying the value.
6. The method of claim 5 wherein the electronic device includes a medical device that measures an analyte concentration in a liquid sample.
7. The method of claim 6 wherein the medical device is a blood glucose meter that measures glucose concentration in blood samples,
- and wherein determining a display color based on the measured or computed value comprises determining a display color based on a measured glucose concentration relative to at least a target blood glucose range.
8. The method of claim 7 wherein determining a display color comprises selecting a first color if the measured glucose concentration is within the target blood glucose range.
9. The method of claim 8 wherein determining a display color comprises selecting a second color different from the first color if the measured glucose concentration is between the target blood glucose range and a low blood glucose value.
10. The method of claim 9 wherein determining a display color comprises selecting a third color different from the first and second colors if the measured glucose concentration is below the low blood glucose value.
11. The method of claim 10 further comprising controlling the display to display a warning message if the measured blood glucose concentration is below the low blood glucose value.
12. The method of claim 10 wherein the low blood glucose value is a hypoglycemic blood glucose threshold.
13. The method of claim 8 wherein determining a display color comprises selecting a fourth color different from the first color if the measured glucose concentration is between the target blood glucose range and a high blood glucose value.
14. The method of claim 13 further comprising controlling the display to display a warning message along with the fourth color if the measured blood glucose concentration is below above the high blood glucose value.
15. The method of claim 14 wherein the high blood glucose value is a hyperglycemic blood glucose threshold.
16. The method of claim 5 wherein determining a measured or computed value comprises computing a value, or receiving a computed value, of a quantity of a drug to be delivered to a body.
17. A method of collecting in an electronic device time-based event data stored in a medical device, the method comprising:
- wirelessly sending by the electronic device a request for the time-based event data,
- wirelessly sending by the medical device time-based event data stored therein since previously wirelessly sending stored time-based event data upon receiving the request for the time-based event data,
- wirelessly sending by the electronic device an acknowledgement signal upon receiving the time-event based data from the another electronic device, and
- identifying by the medical device a location in memory of the last item of the time-event based data that was sent to the electronic device upon receiving the acknowledgement signal.
18. The method of claim 17 wherein the medical device is a liquid infusion pump and the time-based event data is time-based infusion pump event data.
19. A method for enabling a bolus advice feature of an electronic device according to which the electronic device recommends delivery of a bolus amount of a drug to a body of a user based on a plurality of factors including glucose concentration of the user, the method comprising:
- disabling the bolus advice feature of the electronic device during manufacture of the electronic device,
- monitoring one of a flag and a memory location when the electronic device is operable after manufacture thereof, and
- enabling the bolus advice feature if one of the flag is activated and the memory location includes a device pairing value.
20. The method of claim 19 wherein monitoring one of a flag and a memory location comprises monitoring a flag,
- and further comprising activating the flag if a predefined password is received by the electronic device.
21. The method of claim 19 wherein monitoring one of a flag and a memory location comprises monitoring a flag,
- and further comprising activating the flag when the electronic device has been successfully paired with another electronic device.
22. The method of claim 21 wherein the another electronic device comprises an ambulatory medical device.
23. The method of claim 19 wherein monitoring one of a flag and a memory location comprises monitoring a memory location,
- and further comprising storing the device pairing value in the memory location when the electronic device has been successfully paired with another electronic device.
24. The method of claim 23 wherein the another electronic device comprises an ambulatory medical device.
25. A method of maintaining a time and date in an electronic device that communicates wirelessly with an ambulatory medical device, the method comprising:
- establishing via the electronic device a wireless communication link between the electronic device and the ambulatory medical device,
- wirelessly sending by the medical device time and date information, corresponding to a calendar date and time of day maintained by the medical device, when the wireless communication link is established, and
- modifying by the electronic device a calendar date and time of day thereof if the time of day received from the medical device time differs from the time of day of the electronic device by more than a predefined time value.
26. The method of claim 25 wherein the electronic device includes a my data feature according to which historical records stored within the electronic device may be viewed,
- and wherein establishing via the electronic device a wireless communication link between the electronic device and the ambulatory medical device comprises establishing the wireless communication link, if one is not already established, when the electronic device enters the my data feature.
27. The method of claim 25 wherein the electronic device includes a bolus advice feature according to which the electronic device recommends delivery of a bolus amount of a drug to a body of a user based on a plurality of factors including glucose concentration of the user,
- and wherein establishing via the electronic device a wireless communication link between the electronic device and the ambulatory medical device comprises establishing the wireless communication link, if one is not already established, when the electronic device enters the bolus advice feature.
28. The method of claim 25 wherein the electronic device includes an on/off switch,
- and wherein establishing via the electronic device a wireless communication link between the electronic device and the ambulatory medical device comprises establishing the wireless communication link, if one is not already established, when the on/off switch is detected as transitioning from an off state to an on state.
29. The method of claim 25 wherein a memory unit of the electronic device has at least one automatic reminder stored therein,
- and wherein establishing via the electronic device a wireless communication link between the electronic device and the ambulatory medical device comprises establishing the wireless communication link, if one is not already established, when the at least one automatic reminder powers on the electronic device from an off state.
30. The method of claim 25 wherein the electronic device includes a remote terminal operating mode according to which the electronic device remote controls operation of the ambulatory medical device,
- and wherein establishing via the electronic device a wireless communication link between the electronic device and the ambulatory medical device comprises establishing the wireless communication link, if one is not already established, when the electronic device exits the remote terminal operating mode.
Type: Application
Filed: Dec 23, 2009
Publication Date: Jun 24, 2010
Inventors: Michael J. Celentano (Fishers, IN), Ulf Meiertoberens (Stocksund), Peter Sabol (Fishers, IN), Raymond Strickland (Indianapolis, IN), Paul J. Galley (Cumberland, IN), Markus Oberli (Kirchberg), Mathias Ehrsam (Bolligen), Erich Imhol (Utzenstorf)
Application Number: 12/646,113
International Classification: A61B 5/145 (20060101); A61M 37/00 (20060101);
