In one or more embodiments, a continuous analyte monitoring wearable device includes a disposable base unit having a power source and an analyte sensor, and a reusable transmitter unit that includes electronic circuitry configured to bias the analyte sensor, measure current through the analyte sensor, and may even compute analyte values based on measured current through the analyte sensor. The disposable base unit is configured to couple to the reusable transmitter unit and supply electrical power to the electronic circuitry of the reusable transmitter unit for continuous analyte monitoring. Numerous other embodiments are provided.
A61B 5/00 - Measuring for diagnostic purposes Identification of persons
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value
A61B 90/00 - Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups , e.g. for luxation treatment or for protecting wound edges
2.
CONTINUOUS ANALYTE MONITORING DEVICES AND SYSTEMS HAVING A LONG-LIFE REUSABLE WIRELESS TRANSMITTER UNIT AND APPLICATION METHODS THEREFOR
A wearable continuous analyte monitoring (CAM) device includes a disposable sensor unit and a long-life reusable transmitter unit. The transmitter unit has no power source and has an enclosure that seals wireless transmitter circuitry within. The disposable sensor unit is configured to receive and provide power to the transmitter unit therein. Upon expiration of the disposable sensor unit, the transmitter unit can be removed from the disposable sensor unit and reused in another disposable sensor unit with a fresh power source. The CAM device has a cover constructed of a fabric material to improve aesthetics and feel of the CAM device. Methods of preparing and applying the CAM device to a user's skin are also provided, as are other aspects.
In response to insertion of a continuous glucose monitoring (CGM) sensor into the skin of user, a CGM system compares an identifier of the sensor to any previously-stored identifiers of previously-inserted sensors. If the identifier does not match a previously-stored identifier, indicating a newly-inserted sensor, the identifier and a time stamp are stored and CGM may begin. Upon removal of the sensor, a removal time stamp is stored. If the identifier of an inserted sensor matches a previously-stored identifier, indicating a reinserted sensor, a reinsertion time is obtained and an elapsed removal time is checked to determine whether it exceeds a maximum removal time limit. If it does, CGM is halted. If it does not, CGM may continue with the reinserted sensor. Methods of tracking insertion and removal times of a CGM sensor are also provided, as are other aspects.
A base unit of a wearable device for continuous analyte monitoring includes a cup configured to receive a power source. A first power source contact is at least partially located in the cup and configured to electrically contact a first terminal of the power source in response to the power source being received in the cup. At least one base contact is electrically coupled to the first power source contact, the at least one base contact configured to electrically contact at least one transmitter contact of a transmitter unit in response to the transmitter unit and the base unit being coupled together. Numerous other embodiments are provided.
A continuous analyte monitor wearable device. The wearable device includes a primary portion comprising at least a sensor assembly comprising a biosensor, and a secondary portion comprising a pocket configured to receive a transmitter unit and a sealable opening to the pocket, the sealable opening containing an adhesive on edges thereof; and a backing member provided over the adhesive wherein removing the backing member exposes the adhesive to seal the sealable opening and encapsulate the transmitter unit. Biosensor inserters and method of using the biosensor inserter are also provided.
A61B 5/00 - Measuring for diagnostic purposes Identification of persons
A61B 5/1486 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value using chemical or electrochemical methods, e.g. by polarographic means using enzyme electrodes, e.g. with immobilised oxidase
6.
METHODS AND APPARATUS TO REDUCE THE IMPACT OF USER-ENTERED DATA ERRORS IN DIABETES MANAGEMENT SYSTEMS
Embodiments provide systems, methods, and apparatus for reducing the impact of user-entered data errors in a data management system (DMS) such as for diabetes. Embodiments include storing user-entered data received from a user into a primary DMS database; storing secondary data received from a source other than the user into a secondary tracking database; associating the secondary data with one or more events described by the user-entered data; cross-checking the user-entered data against the associated secondary data; evaluating user-entered data based on the cross-checking results; presenting for review evaluated user-entered data; treating user-entered data in the primary DMS database based on review results; and determining a diabetes management plan based on the treated user-entered data. Numerous other aspects are provided.
G16H 10/60 - ICT specially adapted for the handling or processing of patient-related medical or healthcare data for patient-specific data, e.g. for electronic patient records
G16H 40/63 - ICT specially adapted for the management or administration of healthcare resources or facilitiesICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for local operation
G16H 40/67 - ICT specially adapted for the management or administration of healthcare resources or facilitiesICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for remote operation
G16Z 99/00 - Subject matter not provided for in other main groups of this subclass
7.
Methods and apparatus to reduce the impact of user-entered data errors in diabetes management systems
Embodiments provide systems, methods, and apparatus for reducing the impact of user-entered data errors in a data management system (DMS) such as for diabetes. Embodiments include storing user-entered data received from a user into a primary DMS database; storing secondary data received from a source other than the user into a secondary tracking database; associating the secondary data with one or more events described by the user-entered data; cross-checking the user-entered data against the associated secondary data; evaluating user-entered data based on the cross-checking results; presenting for review evaluated user-entered data; treating user-entered data in the primary DMS database based on review results; and determining a diabetes management plan based on the treated user-entered data. Numerous other aspects are provided.
G16H 10/60 - ICT specially adapted for the handling or processing of patient-related medical or healthcare data for patient-specific data, e.g. for electronic patient records
G16H 40/63 - ICT specially adapted for the management or administration of healthcare resources or facilitiesICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for local operation
G16H 40/67 - ICT specially adapted for the management or administration of healthcare resources or facilitiesICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for remote operation
G16Z 99/00 - Subject matter not provided for in other main groups of this subclass
8.
NFC-enabled test sensors, systems and methods using the same
An electrochemical test sensor is adapted to receive a fluid sample including an analyte. The electrochemical test sensor includes a base. The base includes an enzyme adapted to react with the analyte. The electrochemical test sensor further includes a plurality of electrodes, a near field communication (NFC) tag chip, an analog front end (AFE) and a microcontroller.
In some embodiments, a sensor assembly for a continuous glucose monitoring system is provided that includes (1) a sensor carrier having a sensor unit receiving area and an electronics receiving area, the electronics receiving area including a substrate; (2) a sensor unit having a sterilized region, the sterilized region including at least a portion of a sensor and an introducer; and (3) electronics for the continuous glucose monitoring system. The sensor unit is positioned within the sensor unit receiving area of the sensor carrier and the electronics are positioned on the substrate within the electronics receiving area of the sensor carrier so as to form a sensor assembly having the sensor electrically connected to the substrate of the electronics receiving area while maintaining sterilization of the sterilized region of the sensor unit. Numerous other aspects are provided.
A continuous glucose monitoring (CGM) device may include a wearable portion having a sensor configured to produce glucose signals from interstitial fluid, a processor, a memory and transmitter circuitry. The memory may include a pre-determined gain function based on a point-of-interest glucose signal and glucose signals measured prior to the point-of-interest glucose signal. The memory may also include computer program code stored therein that, when executed by the processor, causes the CGM device to (a) measure and store a plurality of glucose signals using the sensor and memory; (b) for a presently-measured glucose signal, employ the plurality of previously-measured glucose signals stored in the memory and the pre-determined gain function to compute a compensated glucose value; and (c) communicate the compensated glucose value to a user of the CGM device. Numerous other embodiments are provided.
A61B 5/1473 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value using chemical or electrochemical methods, e.g. by polarographic means invasive, e.g. introduced into the body by a catheter
A61B 5/00 - Measuring for diagnostic purposes Identification of persons
G06F 17/18 - Complex mathematical operations for evaluating statistical data
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value
A61B 5/1495 - Calibrating or testing in vivo probes
11.
Sensor assembly apparatus and methods for continuous glucose monitors
A sensor apparatus for a continuous glucose monitoring system has a sensor housing that includes a first end having a sealing surface configured to seal against an introducer having an insertion shaft, a second end having a sealing surface configured to seal against an insertion shaft cover, and an insertion shaft opening having a width that allows the insertion shaft to travel there through and that extends between the first and second ends. The sensor housing may further include a sensor wire channel that extends between the insertion shaft opening and a sensor wire contact location in an outer surface of the sensor housing. The sensor wire channel and sensor wire contact location may be configured to receive a sensor that extends between the insertion shaft opening and the sensor wire contact location to allow the sensor to make electrical contact to system circuitry. Numerous other aspects are provided.
An apparatus for inserting a continuous analyte monitoring transmitter that includes an outer member, an inner member configured to telescope relative to the outer member, a transmitter, a bias member, an insertion device, and a pivot member. Force is applied to press the outer member toward an insertion site over the duration of a stroke. During a first portion of the stroke, the pivot member cannot pivot and the motion of the outer member translates to the insertion device until the biosensor is inserted at the insertion site. Over a second portion of the stroke, the continued motion causes a first pivot window in the outer member to overlap with a second pivot window in the inner member, allowing the pivot member to pivot and retract the insertion device from the insertion site, leaving the implanted biosensor. Upon completion of the stroke, the position of the pivot member is locked into place by engaging a locking feature of the bias member with the second pivot window to prevent the insertion member from re-entering the insertion site.
A battery-operated electronic device, such as, e.g., a continuous glucose monitoring (CGM) transmitter, has a switch disconnect circuit that reduces battery discharge while the device is stored and/or in “shelf mode.” The device has two externally-accessible activation pads each configured to contact a same electrical conductor positioned in packaging for the device that causes the switch disconnect circuit to disconnect the battery from device electronics while the device is in the packaging. Upon removal of the device from the packaging, the two activation pads no longer contact the electrical conductor, causing the switch disconnect circuit to automatically connect the battery to the device electronics. Methods of reducing battery discharge in a battery-operated electronic device and other aspects are also described.
A biosensor inserter includes a push member with a push element, a contact member including a latch, a transmitter carrier supporting a transmitter and sensor assembly, and a pivot member having a latch end, the pivot member supporting an insertion device during biosensor insertion. In operation, the push member is telescoped axially by the user relative to the contact member, which is provided in contact with a user's skin. This pushes the push element against the pivot member and translates the transmitter carrier during insertion of the biosensor. During a first portion of a stroke of the insertion device, insertion of the biosensor is accomplished, and the pivot member is prevented from pivoting. In a second portion of the stroke, after latch end moves past the latch, the pivot member is allowed to pivot and the insertion device is retracted. Other system and method embodiments are provided.
Some embodiments of the present invention include pairing two wireless devices by placing at least one of two devices in a pairing mode; performing at least one pairing motion event with at least one of the wireless devices to satisfy at least one pairing condition; detecting satisfaction of the at least one pairing condition; and pairing the two wireless devices in response to detecting satisfaction of the at least one pairing condition. Numerous other aspects are provided.
H04W 4/80 - Services using short range communication, e.g. near-field communication [NFC], radio-frequency identification [RFID] or low energy communication
A61B 5/00 - Measuring for diagnostic purposes Identification of persons
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value
G06F 3/01 - Input arrangements or combined input and output arrangements for interaction between user and computer
H04M 1/72412 - User interfaces specially adapted for cordless or mobile telephones with means for local support of applications that increase the functionality by interfacing with external accessories using two-way short-range wireless interfaces
H04W 4/02 - Services making use of location information
H04W 4/20 - Services signallingAuxiliary data signalling, i.e. transmitting data via a non-traffic channel
H04W 4/60 - Subscription-based services using application servers or record carriers, e.g. SIM application toolkits
H04L 67/51 - Discovery or management thereof, e.g. service location protocol [SLP] or web services
H04W 4/06 - Selective distribution of broadcast services, e.g. multimedia broadcast multicast service [MBMS]Services to user groupsOne-way selective calling services
A wearable continuous analyte monitoring (CAM) device includes a disposable sensor unit and a long-life reusable transmitter unit. The transmitter unit has no power source and has an enclosure that seals wireless transmitter circuitry within. The disposable sensor unit is configured to receive and provide power to the transmitter unit therein. Upon expiration of the disposable sensor unit, the transmitter unit can be removed from the disposable sensor unit and reused in another disposable sensor unit with a fresh power source. The CAM device has a cover constructed of a fabric material to improve aesthetics and feel of the CAM device. Methods of preparing and applying the CAM device to a user's skin are also provided, as are other aspects.
A base unit of a wearable device for continuous analyte monitoring includes a cup configured to receive a power source. A first power source contact is at least partially located in the cup and configured to electrically contact a first terminal of the power source in response to the power source being received in the cup. At least one base contact is electrically coupled to the first power source contact, the at least one base contact configured to electrically contact at least one transmitter contact of a transmitter unit in response to the transmitter unit and the base unit being coupled together. Numerous other embodiments are provided.
A biosensor inserter is configured to insert a biosensor. The biosensor inserter includes a push member including a receiver, a contact member translatable relative to the push member, and a trocar holder having a sheath configured to receive a trocar assembly including a trocar therein. The trocar holder is configured to be insertable into, and removable from, the receiver. Thus, an amount of medical waste can be minimized by discarding only the removable trocar holder and trocar assembly after use. System and method embodiments are provided.
A continuous analyte monitor wearable device. The wearable device includes a primary portion comprising at least a sensor assembly comprising a biosensor, and a secondary portion comprising a pocket configured to receive a transmitter unit and a sealable opening to the pocket, the sealable opening containing an adhesive on edges thereof; and a backing member provided over the adhesive wherein removing the backing member exposes the adhesive to seal the sealable opening and encapsulate the transmitter unit. Biosensor inserters and method of using the biosensor inserter are also provided.
A61B 5/00 - Measuring for diagnostic purposes Identification of persons
A61B 5/1486 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value using chemical or electrochemical methods, e.g. by polarographic means using enzyme electrodes, e.g. with immobilised oxidase
21.
Flexible circuit boards for continuous analyte monitoring devices
A flexible circuit board for a continuous analyte monitoring (CAM) device includes a plurality of physically separate circuit board cells each having circuitry thereon. The flexible circuit board also includes a plurality of flexible interconnections each connecting one of the physically separate circuit board cells to another of the physically separate circuit board cells. Each one of the flexible interconnections is operable to couple power, electrical signals, or both to the physically separate circuit board cells connected thereto. The flexible circuit board is bendable in multiple directions in three dimensions. Methods of constructing flexible circuit boards for CAM devices are also provided, as are other aspects.
An electrochemical test sensor is adapted to receive a fluid sample including an analyte. The electrochemical test sensor includes a base. The base includes an enzyme adapted to react with the analyte. The electrochemical test sensor further includes a plurality of electrodes, a near field communication (NFC) tag chip, an analog front end (AFE) and a microcontroller.
A system for determining analyte information of a fluid sample includes an electrochemical test sensor, an NFC-enabled dongle and an NFC-enabled reader. The test sensor includes a base, an enzyme adapted to react with the analyte, electrodes and test-sensor contacts. The NFC-enabled dongle includes a near field communication (NFC) tag chip, an analog front end (AFE), and a microcontroller. The dongle includes an exterior covering that forms an opening for receiving the test sensor. The NFC-enabled reader wirelessly receives data from the dongle to assist in determining the analyte information of the fluid sample. Another system for determining analyte information of a fluid sample includes an electrochemical test sensor, a Bluetooth-enabled dongle and a Bluetooth-enabled reader.
H04W 4/80 - Services using short range communication, e.g. near-field communication [NFC], radio-frequency identification [RFID] or low energy communication
A method of predicting an analyte concentration trend to provide a user with an opportunity to take therapeutic measures, if needed, includes receiving a plurality of past measured analyte concentrations between a time t0 of a most recent measured analyte concentration and a time tP of an earlier measured analyte concentration; calculating a data set comprising differences in measured analyte concentrations between consecutive measured analyte concentrations between the time tP and the time t0; and predicting whether a hypo/hyper analyte concentration event will occur within a predetermined time period after the time t0 based at least in part on the first data set. Other methods and apparatus are also disclosed.
A method of calculating slope in a graph of analyte concentrations to provide a user with trend information includes receiving a plurality of past analyte concentrations between a time t0 of a most recent analyte concentration and a time tP of an earlier analyte concentration; calculating a first data set comprising differences in analyte concentrations between consecutive analyte concentrations between the time tP and the time t0; and calculating a slope of the analyte concentration at time t0 based at least in part on the first data set. Other methods and apparatus are disclosed.
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value
A61B 5/1455 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value using optical sensors, e.g. spectral photometrical oximeters
A method of displaying a projected range of future analyte concentrations includes determining a current analyte concentration G(t0) at a present time t0; projecting an analyte concentration G(tA) at a time tA; calculating a deviation R(tA) from the projected analyte concentration G(tA); and displaying at least one indicium indicating the deviation R(tA). Other methods and apparatus are also disclosed.
A coupling tool for coupling together an electronics unit and a base unit of a wearable device for continuous analyte monitoring includes a carrier comprising a receiving feature and a carrier retention device, the carrier retention device configured to retain an electronics unit adjacent the receiving feature. The coupling tool also includes an activator including: a first member at least partially receivable in the receiving feature and a contact member configured to release the electronics unit from the carrier retention device in response to movement of the activator relative to the carrier. The coupling tool is in a locked configuration when the carrier retention device is configured to retain the electronics unit, and the coupling tool is in an unlocked configuration when the carrier retention device is configured to release the electronics unit from the carrier retention device. Other embodiments and methods are also disclosed.
A method of determining glucose values during continuous glucose monitoring (CGM) measurements includes providing a CGM device including a sensor, a memory, and a processor; applying a constant voltage potential to the sensor; measuring a primary current signal resulting from the constant voltage potential and storing the measured primary current signal in the memory; applying a probing potential modulation sequence to the sensor; measuring probing potential modulation current signals resulting from the probing potential modulation sequence and storing measured probing potential modulation current signals in the memory; determining an initial glucose concentration based on a conversion function and a measured probing potential modulation current signal; determining a connection function value based on the primary current signal and a plurality of the probing potential modulation current signals; and determining a final glucose concentration based on the initial glucose concentration and the connection function value. Other aspects are disclosed.
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value
A61B 5/00 - Measuring for diagnostic purposes Identification of persons
A61B 5/1486 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value using chemical or electrochemical methods, e.g. by polarographic means using enzyme electrodes, e.g. with immobilised oxidase
A61B 5/1495 - Calibrating or testing in vivo probes
G01N 33/487 - Physical analysis of biological material of liquid biological material
G01N 33/49 - Physical analysis of biological material of liquid biological material blood
G16H 40/40 - ICT specially adapted for the management or administration of healthcare resources or facilitiesICT specially adapted for the management or operation of medical equipment or devices for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades
G16H 40/67 - ICT specially adapted for the management or administration of healthcare resources or facilitiesICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for remote operation
G16H 50/30 - ICT specially adapted for medical diagnosis, medical simulation or medical data miningICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for calculating health indicesICT specially adapted for medical diagnosis, medical simulation or medical data miningICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for individual health risk assessment
G16H 50/70 - ICT specially adapted for medical diagnosis, medical simulation or medical data miningICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for mining of medical data, e.g. analysing previous cases of other patients
29.
BIOSENSOR WITH MEMBRANE STRUCTURE FOR STEADY-STATE AND NON-STEADY-STATE CONDITIONS FOR DETERMINING ANALYTE CONCENTRATIONS
A biosensor system is configured to establish a steady-state condition and alternate between the steady-state condition and a non-steady-state condition to determine an analyte concentration. The biosensor system includes an electrode system having at least one working electrode and one counter electrode. The working electrode is covered with an analyte catalyzing layer for converting an analyte into measurable species. A membrane system encompasses the electrode system and comprises an analyte permeable membrane. The membrane has an analyte permeability with lower analyte solubility than an analyte solubility outside the membrane. The membrane is configured to trap a measureable species within the membrane such that a steady-state of the measurable species resulting from the analyte is established near the electrode surface. A bias circuit is configured to apply a potential modulation sequence to the working electrode to cause alternating of steady-state and non-steady-state conditions within the electrode system for analyte concentration determination.
A61B 5/1486 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value using chemical or electrochemical methods, e.g. by polarographic means using enzyme electrodes, e.g. with immobilised oxidase
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value
A61B 5/00 - Measuring for diagnostic purposes Identification of persons
30.
Extracting parameters for analyte concentration determination
A method of determining glucose values during continuous glucose monitoring (CGM) measurements includes providing a CGM device including a sensor, a memory, and a processor; applying a constant voltage potential to the sensor; measuring a primary current signal resulting from the constant voltage potential and storing the measured primary current signal in the memory; applying a probing potential modulation sequence to the sensor; measuring probing potential modulation current signals resulting from the probing potential modulation sequence and storing measured probing potential modulation current signals in the memory; determining an initial glucose concentration based on a conversion function and a ratio of measured probing potential modulation current signals; determining a connection function value based on the primary current signal and a plurality of the probing potential modulation current signals; and determining a final glucose concentration based on the initial glucose concentration and the connection function value. Other aspects are disclosed.
G16H 40/67 - ICT specially adapted for the management or administration of healthcare resources or facilitiesICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for remote operation
A61B 5/00 - Measuring for diagnostic purposes Identification of persons
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value
A61B 5/1486 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value using chemical or electrochemical methods, e.g. by polarographic means using enzyme electrodes, e.g. with immobilised oxidase
A61B 5/1495 - Calibrating or testing in vivo probes
G01N 33/487 - Physical analysis of biological material of liquid biological material
G01N 33/49 - Physical analysis of biological material of liquid biological material blood
G16H 40/40 - ICT specially adapted for the management or administration of healthcare resources or facilitiesICT specially adapted for the management or operation of medical equipment or devices for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades
G16H 50/30 - ICT specially adapted for medical diagnosis, medical simulation or medical data miningICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for calculating health indicesICT specially adapted for medical diagnosis, medical simulation or medical data miningICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for individual health risk assessment
G16H 50/70 - ICT specially adapted for medical diagnosis, medical simulation or medical data miningICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for mining of medical data, e.g. analysing previous cases of other patients
31.
Continuous analyte monitoring sensor calibration and measurements by a connection function
A method of determining glucose values during continuous glucose monitoring (CGM) measurements includes providing a CGM device including a sensor, a memory, and a processor; applying a constant voltage potential to the sensor; measuring a primary current signal resulting from the constant voltage potential and storing the measured primary current signal in the memory; applying a probing potential modulation sequence to the sensor; measuring probing potential modulation current signals resulting from the probing potential modulation sequence and storing measured probing potential modulation current signals in the memory; determining an initial glucose concentration based on a conversion function value and the primary current signal; determining a connection function based on the primary current signal and a plurality of the probing potential modulation current signals; and determining a final glucose concentration based on the initial glucose concentration and the connection function value. Other aspects are provided.
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value
A61B 5/00 - Measuring for diagnostic purposes Identification of persons
G16H 40/67 - ICT specially adapted for the management or administration of healthcare resources or facilitiesICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for remote operation
A61B 5/1486 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value using chemical or electrochemical methods, e.g. by polarographic means using enzyme electrodes, e.g. with immobilised oxidase
G01N 33/487 - Physical analysis of biological material of liquid biological material
G01N 33/49 - Physical analysis of biological material of liquid biological material blood
G16H 50/30 - ICT specially adapted for medical diagnosis, medical simulation or medical data miningICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for calculating health indicesICT specially adapted for medical diagnosis, medical simulation or medical data miningICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for individual health risk assessment
G16H 50/70 - ICT specially adapted for medical diagnosis, medical simulation or medical data miningICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for mining of medical data, e.g. analysing previous cases of other patients
G16H 40/40 - ICT specially adapted for the management or administration of healthcare resources or facilitiesICT specially adapted for the management or operation of medical equipment or devices for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades
A61B 5/1495 - Calibrating or testing in vivo probes
32.
Tracking insertion and removal times of a continuous glucose monitoring sensor
In response to insertion of a continuous glucose monitoring (CGM) sensor into the skin of user, a CGM system compares an identifier of the sensor to any previously-stored identifiers of previously-inserted sensors. If the identifier does not match a previously-stored identifier, indicating a newly-inserted sensor, the identifier and a time stamp are stored and CGM may begin. Upon removal of the sensor, a removal time stamp is stored. If the identifier of an inserted sensor matches a previously-stored identifier, indicating a reinserted sensor, a reinsertion time is obtained and an elapsed removal time is checked to determine whether it exceeds a maximum removal time limit. If it does, CGM is halted. If it does not, CGM may continue with the reinserted sensor. Methods of tracking insertion and removal times of a CGM sensor are also provided, as are other aspects.
A continuous glucose monitoring (CGM) system is configured to detect a reinserted CGM sensor. The system reads a CGM sensor identifier stored in a CGM sensor unit memory in response to insertion of a CGM sensor into the skin of user. The system compares the identifier to any previously-stored identifiers of previously-inserted CGM sensors. If the identifier does not match a previously-stored identifier, indicating a newly-inserted sensor, the identifier is stored and CGM may begin. If the identifier matches a previously-stored identifier, indicating a reinserted sensor, a usage limit corresponding to the stored identifier of the reinserted sensor is then checked to determine whether it has been met. If it has, CGM is halted. If it has not, CGM may continue with the reinserted CGM sensor. Methods of detecting reinsertion and usage limits of a CGM sensor are also provided, as are other aspects.
A method of filtering a signal in a continuous analyte monitoring (CAM) system includes applying time-varying filtering to the signal using a time-varying filter to generate a filtered continuous analyte monitoring signal during an analyte monitoring period. Other methods, apparatus, continuous analyte monitoring devices, and continuous glucose monitoring devices are also disclosed.
A61B 5/00 - Measuring for diagnostic purposes Identification of persons
G16H 40/63 - ICT specially adapted for the management or administration of healthcare resources or facilitiesICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for local operation
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value
A61B 5/1486 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value using chemical or electrochemical methods, e.g. by polarographic means using enzyme electrodes, e.g. with immobilised oxidase
35.
Methods and apparatus for adaptive filtering of signals of continuous analyte monitoring systems
A method of filtering a signal in a continuous analyte monitoring system (CAM) includes applying adaptive filtering to the signal using an adaptive filter to generate a filtered continuous analyte monitoring signal during an analyte monitoring period, and increasing the adaptive filtering applied to the signal as a function of increasing noise on the signal. Other methods, apparatus, continuous analyte monitoring devices, and continuous glucose monitoring devices are also disclosed.
A61B 5/00 - Measuring for diagnostic purposes Identification of persons
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value
A61B 5/1486 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value using chemical or electrochemical methods, e.g. by polarographic means using enzyme electrodes, e.g. with immobilised oxidase
G16H 10/60 - ICT specially adapted for the handling or processing of patient-related medical or healthcare data for patient-specific data, e.g. for electronic patient records
G16H 40/67 - ICT specially adapted for the management or administration of healthcare resources or facilitiesICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for remote operation
G16H 50/30 - ICT specially adapted for medical diagnosis, medical simulation or medical data miningICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for calculating health indicesICT specially adapted for medical diagnosis, medical simulation or medical data miningICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for individual health risk assessment
36.
METHODS AND APPARATUS CONFIGURED TO TRANSMIT DATA IN CONTINUOUS ANALYTE MONITORS
In one or more embodiments, a base unit of a wearable device for continuous analyte monitoring may include sensor memory circuitry and a sensor assembly. The sensor memory circuitry stores information (data) of at least one parameter of at least one component of the base unit, such as, e.g., the sensor assembly. The base unit is configured to couple to a transmitter unit of the wearable device and to transfer the information to the transmitter unit. Analyte determinations are made based at least in part on the information. Numerous other embodiments are provided.
A flexible printed circuit board (PCB) may have one or more coin cell batteries mounted thereto such that the flexibility of the flexible PCB is maintained. The flexible PCB has one or more battery contact pads fabricated thereon. Each battery contact pad includes a pattern of metalized vias each extending from a top surface to a bottom surface of the flexible PCB. A coin cell battery may be positioned over or under the battery contact pad. Conductive light curable epoxy is applied to and in each metalized via to contact and adhere to the coin cell battery to form a conductive path from the battery through the battery contact pad to printed conductors on the flexible PCB. Methods of mounting one or more coin cell batteries to a flexible PCB are also provided, as are other aspects.
WEARABLE DEVICES, WEARABLE DEVICE FORMING METHODS, AND METHODS OF REUSE OF TRANSMITTER UNITS OF WEARABLE DEVICES IN CONTINUOUS ANALYTE MONITORING SYSTEMS
In one or more embodiments, a continuous analyte monitoring wearable device includes a disposable base unit having a power source and an analyte sensor, and a reusable transmitter unit that includes electronic circuitry configured to bias the analyte sensor, measure current through the analyte sensor, and, in some embodiments, even compute analyte values based on measured current through the analyte sensor. The disposable base unit is configured to couple to the reusable transmitter unit and supply electrical power to the electronic circuitry of the reusable transmitter unit for continuous analyte monitoring. Numerous other embodiments are provided.
In one or more embodiments, a continuous analyte monitoring wearable device includes a disposable base unit having a power source and an analyte sensor, and a reusable transmitter unit that includes electronic circuitry configured to bias the analyte sensor, measure current through the analyte sensor, and may even compute analyte values based on measured current through the analyte sensor. The disposable base unit is configured to couple to the reusable transmitter unit and supply electrical power to the electronic circuitry of the reusable transmitter unit for continuous analyte monitoring. Numerous other embodiments are provided.
A61B 5/00 - Measuring for diagnostic purposes Identification of persons
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value
A61B 90/00 - Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups , e.g. for luxation treatment or for protecting wound edges
A test sensor for determining an analyte concertation in a biological fluid comprises a strip including a fluid receiving area and port-insertion region. A first row of optically transparent and non-transparent positions forms a calibration code pattern disposed within a first area of the port-insertion region. A second row of optically transparent and non-transparent positions forms a synchronization code pattern disposed within a second area of the port-insertion region. The second area is different from the first area. The synchronization code pattern corresponds to the calibration code pattern such that the synchronization code pattern provides synchronization of the serial calibration code pattern during insertion of the port-insertion region into the receiving port of the analyte meter.
G01N 21/78 - Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated by observing the effect on a chemical indicator producing a change of colour
G01N 33/487 - Physical analysis of biological material of liquid biological material
G01N 21/84 - Systems specially adapted for particular applications
G01N 33/49 - Physical analysis of biological material of liquid biological material blood
G01N 21/77 - Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated by observing the effect on a chemical indicator
41.
Devices, systems, and methods for measuring analytes in interstitial fluid
An analyte monitor includes a controller including a processor coupled to a memory. The memory has instructions stored therein that, when executed by the processor, cause the controller to: provide a working electrode voltage to a working electrode of an analyte sensor; selectively provide a first counter electrode voltage and a second counter electrode voltage to a counter electrode of the analyte sensor; and provide a guard ring voltage to a guard ring associated with the working electrode. The analyte monitor further includes a current measurement circuit coupled to the controller and configured to measure current flow to the working electrode and a reference resistor electrically coupled between the working electrode and the guard ring associated with the working electrode. Other monitors, systems, sensors, and methods are disclosed.
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value
A61B 5/00 - Measuring for diagnostic purposes Identification of persons
A61B 5/1486 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value using chemical or electrochemical methods, e.g. by polarographic means using enzyme electrodes, e.g. with immobilised oxidase
A method for using a meter and a meter (10) adapted to determine an analyte concentration reading, the meter comprising a display (12) adapted to display information to a user of the meter, the display including information directed to a post-meal test-time alarm (22″) that is adapted to remind the user to obtain a post-meal analyte concentration reading, and at least one user input mechanism (15) adapted to allow the user to activate the post-meal test-time alarm.
G16H 40/63 - ICT specially adapted for the management or administration of healthcare resources or facilitiesICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for local operation
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value
A61B 5/00 - Measuring for diagnostic purposes Identification of persons
G08B 21/24 - Reminder alarms, e.g. anti-loss alarms
G16H 20/10 - ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients
43.
Automatic activation of continuous glucose monitoring (CGM) transmitter
A battery-operated electronic device, such as, e.g., a continuous glucose monitoring (CGM) transmitter, has a switch disconnect circuit that reduces battery discharge while the device is stored and/or in “shelf mode.” The device has two externally-accessible activation pads each configured to contact a same electrical conductor positioned in packaging for the device that causes the switch disconnect circuit to disconnect the battery from device electronics while the device is in the packaging. Upon removal of the device from the packaging, the two activation pads no longer contact the electrical conductor, causing the switch disconnect circuit to automatically connect the battery to the device electronics. Methods of reducing battery discharge in a battery-operated electronic device and other aspects are also described.
A continuous glucose monitoring (CGM) device may include a wearable portion having a sensor configured to produce glucose signals from interstitial fluid, a processor, a memory and transmitter circuitry. The memory may include a pre-determined gain function based on a point-of-interest glucose signal and glucose signals measured prior to the point-of-interest glucose signal. The memory may also include computer program code stored therein that, when executed by the processor, causes the CGM device to (a) measure and store a plurality of glucose signals using the sensor and memory; (b) for a presently-measured glucose signal, employ the plurality of previously-measured glucose signals stored in the memory and the pre-determined gain function to compute a compensated glucose value; and (c) communicate the compensated glucose value to a user of the CGM device. Numerous other embodiments are provided.
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value
A61B 5/00 - Measuring for diagnostic purposes Identification of persons
A61B 5/1473 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value using chemical or electrochemical methods, e.g. by polarographic means invasive, e.g. introduced into the body by a catheter
A61B 5/1486 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value using chemical or electrochemical methods, e.g. by polarographic means using enzyme electrodes, e.g. with immobilised oxidase
A61B 5/1495 - Calibrating or testing in vivo probes
G06F 17/18 - Complex mathematical operations for evaluating statistical data
45.
Methods and apparatus for information gathering, error detection and analyte concentration determination during continuous analyte sensing
A continuous glucose monitoring (CGM) device may include a wearable portion having a sensor configured to produce glucose signals from interstitial fluid, a processor, a memory and transmitter circuitry. The memory may include a pre-determined gain function based on a point-of-interest glucose signal and glucose signals measured prior to the point-of-interest glucose signal. The memory may also include computer program code stored therein that, when executed by the processor, causes the CGM device to (a) measure and store a plurality of glucose signals using the sensor and memory; (b) for a presently-measured glucose signal, employ the plurality of previously-measured glucose signals stored in the memory and the pre-determined gain function to compute a compensated glucose value; and (c) communicate the compensated glucose value to a user of the CGM device. Numerous other embodiments are provided.
G06F 17/18 - Complex mathematical operations for evaluating statistical data
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value
A61B 5/1495 - Calibrating or testing in vivo probes
A61B 5/1473 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value using chemical or electrochemical methods, e.g. by polarographic means invasive, e.g. introduced into the body by a catheter
A61B 5/00 - Measuring for diagnostic purposes Identification of persons
46.
Continuous analyte monitor inserter apparatus and methods
An inserter apparatus (e.g., a continuous analyte monitoring inserter apparatus) includes an outer member; an inner member; a transmitter carrier configured to support a transmitter and biosensor assembly during insertion of a biosensor, the transmitter carrier including a bias member; and a pivot member configured to pivot at times relative to the transmitter carrier and support an insertion device during biosensor insertion. The outer member is configured to press the bias member against the pivot member during insertion of the biosensor. During a first stroke portion of the insertion apparatus, the pivot member is prevented from pivoting. In a second stroke portion, pivoting is allowed, and the bias member causes, pivoting of the pivot member and retraction of the insertion device. Other systems and methods embodiments are provided.
A biosensor inserter includes a push member with a push element, a contact member including a latch, a transmitter carrier supporting a transmitter and sensor assembly, and a pivot member having a latch end, the pivot member supporting an insertion device during biosensor insertion. In operation, the push member is telescoped axially by the user relative to the contact member, which is provided in contact with a user's skin. This pushes the push element against the pivot member and translates the transmitter carrier during insertion of the biosensor. During a first portion of a stroke of the insertion device, insertion of the biosensor is accomplished, and the pivot member is prevented from pivoting. In a second portion of the stroke, after latch end moves past the latch, the pivot member is allowed to pivot and the insertion device is retracted. Other system and method embodiments are provided.
The cartridge comprises a housing, a plurality of test sensors, a mechanical mechanism, and a pusher assembly. The housing forms at least one opening therethrough. The plurality of test sensors is stacked in the housing. The plurality of test sensors is adapted to assist in testing at least one analyte. The mechanical mechanism is adapted to urge the plurality of test sensors in a first direction. One of the plurality of test sensors is positioned for extraction from the cartridge. The pusher assembly is adapted to push one of the plurality of test sensors from the cartridge. The pusher assembly includes a ferromagnetic material or a magnet.
A portable data-management system based on an analyte testing device which communicates wirelessly with a mobile device. The mobile device runs an application to manage and analyze data obtained by the analyte testing device. The mobile device may assist the user in displaying testing data, identifying patterns to assist healthy behavior or issue warnings based on the collected data. The mobile device may be connected to a network to store user health data for use by other parties.
G16H 10/40 - ICT specially adapted for the handling or processing of patient-related medical or healthcare data for data related to laboratory analysis, e.g. patient specimen analysis
A61B 5/00 - Measuring for diagnostic purposes Identification of persons
G16H 40/63 - ICT specially adapted for the management or administration of healthcare resources or facilitiesICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for local operation
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value
C12Q 1/54 - Measuring or testing processes involving enzymes, nucleic acids or microorganismsCompositions thereforProcesses of preparing such compositions involving glucose or galactose
G01N 33/66 - Chemical analysis of biological material, e.g. blood, urineTesting involving biospecific ligand binding methodsImmunological testing involving blood sugars, e.g. galactose
A61B 5/1486 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value using chemical or electrochemical methods, e.g. by polarographic means using enzyme electrodes, e.g. with immobilised oxidase
50.
Sensor clip for stacked sensor dispensing system, and systems, methods and devices for making and using the same
Sensor clip assemblies, sensor clips, analyte testing systems, and methods for making and using the same are disclosed. A sensor clip assembly is disclosed for storing and dispensing analyte testing sensors. The sensor clip assembly includes numerous test sensors arranged in a stack. Each test sensor is configured to assist in testing an analyte in a fluid sample. The sensor clip assembly also includes a skeletal frame with a top, a bottom, and numerous sides. The top, bottom and sides are interconnected to define an internal chamber within which is stored the stack of test sensors. At least one of the sides includes one or more elongated rails with structural gaps on opposing sides thereof. For some configurations, multiple sides of the skeletal frame comprise at least one or multiple elongated rails, each of which has structural gaps on opposing sides thereof and may be columnar in nature.
A61B 5/157 - Devices for taking samples of blood characterised by integrated means for measuring characteristics of blood
B65D 83/08 - Containers or packages with special means for dispensing contents for dispensing thin flat articles in succession
C12Q 1/00 - Measuring or testing processes involving enzymes, nucleic acids or microorganismsCompositions thereforProcesses of preparing such compositions
G01N 21/78 - Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated by observing the effect on a chemical indicator producing a change of colour
G01N 21/77 - Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated by observing the effect on a chemical indicator
51.
Methods and apparatus for analyte concentration monitoring using harmonic relationships
Continuous glucose monitoring (CGM) may include applying a periodic excitation signal via an electrode of a CGM sensor to human interstitial fluid to drive an oxidation/reduction reaction, and measuring the current through the electrode. In some embodiments, the measured current is sampled and digitized, and various harmonics of the excitation signal's fundamental frequency are extracted. A set of relationships of at least two harmonics each is generated from the spectral amplitudes of a set of pairs, triplets, etc., of the harmonics, and the set of relationships is mapped to a glucose concentration such as based on the contents of a harmonic relationship database having a pre-existing set of harmonic relationships and glucose concentrations to which those sets of harmonic relationships correspond, for example. Numerous other embodiments are provided.
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value
A61B 5/1477 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value using chemical or electrochemical methods, e.g. by polarographic means non-invasive
A61B 5/00 - Measuring for diagnostic purposes Identification of persons
G01N 33/66 - Chemical analysis of biological material, e.g. blood, urineTesting involving biospecific ligand binding methodsImmunological testing involving blood sugars, e.g. galactose
G06F 1/16 - Constructional details or arrangements
G06F 17/14 - Fourier, Walsh or analogous domain transformations
A61B 5/1473 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value using chemical or electrochemical methods, e.g. by polarographic means invasive, e.g. introduced into the body by a catheter
G01N 31/00 - Investigating or analysing non-biological materials by the use of the chemical methods specified in the subgroupsApparatus specially adapted for such methods
H04Q 9/00 - Arrangements in telecontrol or telemetry systems for selectively calling a substation from a main station, in which substation desired apparatus is selected for applying a control signal thereto or for obtaining measured values therefrom
A reagent for detecting an analyte comprises a flavoprotein enzyme, a mediator such as a phenothiazine mediator, at least one surfactant, a polymer and a buffer. The reagent may be used with an electrochemical test sensor that includes a plurality of electrodes.
C12Q 1/00 - Measuring or testing processes involving enzymes, nucleic acids or microorganismsCompositions thereforProcesses of preparing such compositions
A sensor system, device, and methods for determining the concentration of an analyte in a sample is described. Gated voltammetric pulse sequences including multiple duty cycles of sequential excitations and relaxations may provide a shorter analysis time and/or improve the accuracy and/or precision of the analysis. The disclosed pulse sequences may reduce analysis errors arising from the hematocrit effect, variance in cap-gap volumes, non-steady-state conditions, mediator background, a single set of calibration constants, under-fill, and changes in the active ionizing agent content of the sensor strip.
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value
A61B 5/1486 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value using chemical or electrochemical methods, e.g. by polarographic means using enzyme electrodes, e.g. with immobilised oxidase
C12Q 1/00 - Measuring or testing processes involving enzymes, nucleic acids or microorganismsCompositions thereforProcesses of preparing such compositions
G01N 33/543 - ImmunoassayBiospecific binding assayMaterials therefor with an insoluble carrier for immobilising immunochemicals
54.
Methods and apparatus for analyte concentration monitoring using harmonic relationships
Continuous glucose monitoring (CGM) may include applying a periodic excitation signal via an electrode of a CGM sensor to human interstitial fluid to drive an oxidation/reduction reaction, and measuring the current through the electrode. In some embodiments, the measured current is sampled and digitized, and various harmonics of the excitation signal's fundamental frequency are extracted. A set of relationships of at least two harmonics each is generated from the spectral amplitudes of a set of pairs, triplets, etc., of the harmonics, and the set of relationships is mapped to a glucose concentration such as based on the contents of a harmonic relationship database having a pre-existing set of harmonic relationships and glucose concentrations to which those sets of harmonic relationships correspond, for example. Numerous other embodiments are provided.
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value
A61B 5/1477 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value using chemical or electrochemical methods, e.g. by polarographic means non-invasive
A61B 5/00 - Measuring for diagnostic purposes Identification of persons
A61B 5/1473 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value using chemical or electrochemical methods, e.g. by polarographic means invasive, e.g. introduced into the body by a catheter
G01N 31/00 - Investigating or analysing non-biological materials by the use of the chemical methods specified in the subgroupsApparatus specially adapted for such methods
G01N 33/66 - Chemical analysis of biological material, e.g. blood, urineTesting involving biospecific ligand binding methodsImmunological testing involving blood sugars, e.g. galactose
G06F 1/16 - Constructional details or arrangements
G06F 17/14 - Fourier, Walsh or analogous domain transformations
H04Q 9/00 - Arrangements in telecontrol or telemetry systems for selectively calling a substation from a main station, in which substation desired apparatus is selected for applying a control signal thereto or for obtaining measured values therefrom
55.
Polymer comprising a plurality of phenothiazine groups and methods of making the same
A non-leaching mediator may include a polymer having a polymeric backbone, and a plurality of phenothiazine groups bonded to the polymeric backbone. The plurality of phenothiazine groups may include at least one of a phenothiazine group having the general formula (IV):
and salts thereof, where n is about 9 and “R” represents the polymeric backbone to which the phenothiazine group is bonded, and a phenothiazine group having the general formula (V):
and salts thereof, where n is about 9 and “R” represents the polymeric backbone to which the phenothiazine group is bonded.
C08F 8/34 - Introducing sulfur atoms or sulfur-containing groups
C07D 279/08 - 1,3-ThiazinesHydrogenated 1,3-thiazines condensed with carbocyclic rings or ring systems
C08F 8/30 - Introducing nitrogen atoms or nitrogen-containing groups
C08G 59/40 - Macromolecules obtained by polymerising compounds containing more than one epoxy group per molecule using curing agents or catalysts which react with the epoxy groups characterised by the curing agents used
C12Q 1/00 - Measuring or testing processes involving enzymes, nucleic acids or microorganismsCompositions thereforProcesses of preparing such compositions
C07D 417/14 - Heterocyclic compounds containing two or more hetero rings, at least one ring having nitrogen and sulfur atoms as the only ring hetero atoms, not provided for by group containing three or more hetero rings
Apparatus and methods are operative to probe the condition of a sensor either initially, at any point thereafter or continuously during a continuous sensor operation for measuring an analyte in a bodily fluid (such as performed by, e.g., a continuous glucose monitoring (CGM) sensor). Results of the probe may include calibration indices determined from electrical signals obtained during the probe. The calibration indices may indicate whether in-situ adjustment of the sensor's calibration should be performed either initially and/or at random check points. Probing potential modulation parameters also may be used during analyte calculations to reduce the effects of lot-to-lot sensitivity variations, sensitivity drift during monitoring, temperature, interferents, and/or the like. Other aspects are disclosed.
A61B 5/1455 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value using optical sensors, e.g. spectral photometrical oximeters
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value
A61B 5/00 - Measuring for diagnostic purposes Identification of persons
A61B 5/1486 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value using chemical or electrochemical methods, e.g. by polarographic means using enzyme electrodes, e.g. with immobilised oxidase
A61B 5/1495 - Calibrating or testing in vivo probes
A61M 5/172 - Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters electrical or electronic
57.
Apparatus and methods for probing sensor operation of continuous analyte sensing and auto-calibration
Apparatus and methods are operative to probe the condition of a sensor either initially, at any point thereafter or continuously during a continuous sensor operation for measuring an analyte in a bodily fluid (such as performed by, e.g., a continuous glucose monitoring (CGM) sensor). Results of the probe may include calibration indices determined from electrical signals obtained during the probe. The calibration indices may indicate whether in-situ adjustment of the sensor's calibration should be performed either initially and/or at random check points. Probing potential modulation parameters also may be used during analyte calculations to reduce the effects of lot-to-lot sensitivity variations, sensitivity drift during monitoring, temperature, interferents, and/or the like. Other aspects are disclosed.
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value
A61B 5/00 - Measuring for diagnostic purposes Identification of persons
A61B 5/1486 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value using chemical or electrochemical methods, e.g. by polarographic means using enzyme electrodes, e.g. with immobilised oxidase
A lancing device has a domed structure that can be depressed by application of a force by a user's finger so as to expose the tip of a needle. The domed structure is configured to move from a non-depressed state to a depressed state in a manner that allows for the piercing of the user's finger. The domed structure may then recoil to its original, non-depressed position upon the user ceasing to apply the force. Other embodiments of a lancing device are disclosed.
A testing system and method for providing a testing system includes a user interface having a display for displaying information relating to measurements of health data and an input device for receiving information from a user relating to the health data. Provided in connection with the user interface is an autologging feature adapted to provide the user with user-selectable options on the display. Also provided is a statistical operation adapted to provide the user with enhanced information relating to the measurements of health data. Also provided is at least one indicator for indicating information relating to the number of health data readings that are within a target range, the number of health data readings that are above the target range and the number of health data readings that are below the target range.
G16H 40/63 - ICT specially adapted for the management or administration of healthcare resources or facilitiesICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for local operation
G16H 10/40 - ICT specially adapted for the handling or processing of patient-related medical or healthcare data for data related to laboratory analysis, e.g. patient specimen analysis
G16H 20/60 - ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to nutrition control, e.g. diets
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value
A61B 5/1459 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value using optical sensors, e.g. spectral photometrical oximeters invasive, e.g. introduced into the body by a catheter
A61B 5/1486 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value using chemical or electrochemical methods, e.g. by polarographic means using enzyme electrodes, e.g. with immobilised oxidase
A61B 5/00 - Measuring for diagnostic purposes Identification of persons
B01L 3/00 - Containers or dishes for laboratory use, e.g. laboratory glasswareDroppers
G16H 15/00 - ICT specially adapted for medical reports, e.g. generation or transmission thereof
G16H 20/10 - ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients
60.
Device pairing taking into account at least one condition
Some embodiments of the present invention include pairing two wireless devices by placing at least one of two devices in a pairing mode; performing at least one pairing motion event with at least one of the wireless devices to satisfy at least one pairing condition; detecting satisfaction of the at least one pairing condition; and pairing the two wireless devices in response to detecting satisfaction of the at least one pairing condition. Numerous other aspects are provided.
H04W 4/02 - Services making use of location information
H04W 4/80 - Services using short range communication, e.g. near-field communication [NFC], radio-frequency identification [RFID] or low energy communication
H04M 1/72412 - User interfaces specially adapted for cordless or mobile telephones with means for local support of applications that increase the functionality by interfacing with external accessories using two-way short-range wireless interfaces
H04W 4/60 - Subscription-based services using application servers or record carriers, e.g. SIM application toolkits
G06F 3/01 - Input arrangements or combined input and output arrangements for interaction between user and computer
A61B 5/00 - Measuring for diagnostic purposes Identification of persons
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value
H04W 48/10 - Access restriction or access information delivery, e.g. discovery data delivery using broadcasted information
H04W 4/20 - Services signallingAuxiliary data signalling, i.e. transmitting data via a non-traffic channel
H04L 67/51 - Discovery or management thereof, e.g. service location protocol [SLP] or web services
H04W 4/06 - Selective distribution of broadcast services, e.g. multimedia broadcast multicast service [MBMS]Services to user groupsOne-way selective calling services
A biosensor system determines analyte concentration from an output signal generated from a light-identifiable species or a redox reaction of the analyte. The biosensor system compensates at least 50% of the total error in the output signal with a primary function and compensates a portion of the remaining error with a residual function. The amount of error compensation provided by the primary and residual functions may be adjusted with a weighing coefficient. The compensation method including a primary function and a residual function may be used to determine analyte concentrations having improved accuracy from output signals including components attributable to error.
A method for using a meter and a meter (10) adapted to determine an analyte concentration reading, the meter comprising a display (12) adapted to display information to a user of the meter, the display including information directed to a post-meal test-time alarm (22″) that is adapted to remind the user to obtain a post-meal analyte concentration reading, and at least one user input mechanism (15) adapted to allow the user to activate the post-meal test-time alarm.
A61B 5/00 - Measuring for diagnostic purposes Identification of persons
G08B 21/24 - Reminder alarms, e.g. anti-loss alarms
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value
G16H 40/63 - ICT specially adapted for the management or administration of healthcare resources or facilitiesICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for local operation
G16H 20/10 - ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients
A test sensor (100) for determining an analyte concentration in a biological fluid comprises a strip including a fluid receiving area (128) and a port-insertion region (126). A first row of optically transparent (132) and non-transparent positions forms a calibration code pattern (130) disposed within a first area of the port-insertion region (126). A second row of optically transparent (142) and non-transparent positions forms a synchronization code pattern (140) disposed within a second area of the port-insertion region (126). The second area is different from the first area. The synchronization code pattern (140) corresponds to the calibration code pattern (130) such that the synchronization code pattern (140) provides synchronization of the serial calibration code pattern (130) during insertion of the port-insertion region (126) into the receiving port of the analyte meter.
G01N 33/48 - Biological material, e.g. blood, urineHaemocytometers
G01N 33/487 - Physical analysis of biological material of liquid biological material
G01N 21/84 - Systems specially adapted for particular applications
G01N 21/78 - Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated by observing the effect on a chemical indicator producing a change of colour
G01N 33/49 - Physical analysis of biological material of liquid biological material blood
G01N 21/77 - Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated by observing the effect on a chemical indicator
64.
Apparatus, systems, and methods for determining and displaying pre-event and post-event analyte concentration levels
Embodiments of the invention provide apparatus, systems, and methods wherein pre-event and post-event analyte concentration readings associated with an event are collected and processed to determine a numerical delta. The numerical delta may be displayed on a visual display to aid in a ready determination of the affect that the event (alone or in combination with medication and/or insulin dosages) had on the analyte concentration levels. Medication and/or insulin dosages may be displayed alongside the numerical delta to gauge immediate relationships between numerical delta, dosage, and/or an associated event. Apparatus and systems for calculating and displaying the numerical delta are described, as are other aspects.
A system and method for rapidly determining ambient temperature in a fluid-analyte meter. The meter includes a housing defining an interior space and an area for receiving a fluid sample. A processor and a first temperature sensor are disposed within the interior space of said the housing. A second temperature sensor is disposed on the housing. One or more processors are configured to determine a first temperature value from temperature data received from the first temperature sensor. The processor(s) are also configured to apply a variable current to a temperature-adjustment source such that the second temperature sensor is adjusted to a predetermined steady-state temperature value different from the first temperature value. The processor(s) are further configured to determine an ambient temperature of an exterior space of the housing based on the applied variable current, pre-determined steady-state temperature, and received first temperature values.
A method of making an electrochemical sensor strip that includes: depositing a first electrode on a base; depositing a second electrode on the base; applying a first layer onto the first electrode; and applying a second layer onto the second electrode. The first layer includes an oxidoreductase and a mediator. The second layer includes a soluble redox species.
C12Q 1/00 - Measuring or testing processes involving enzymes, nucleic acids or microorganismsCompositions thereforProcesses of preparing such compositions
67.
Identifying ionizable species with voltammetric duty cycles
A sensor system including devices and methods for determining the concentration of an analyte in a sample is described. Input signals including amperometric and voltammetric duty cycles of excitations and relaxations may provide a shorter analysis time and/or improve the accuracy and/or precision of the analysis. The disclosed system may reduce analysis errors, thus improving measurement performance, by adjusting the potential and/or scan rate in response to output currents obtained from voltammetric scans. The disclosed system also may determine the concentration of more than one ionizable species in the sample by adjusting the potential and/or scan rate in response to output currents obtained from voltammetric scans. The multiple, determined concentrations may be used to determine the concentration of multiple analytes or to correct the concentration determined for an analyte, thus improving the measurement performance of the system.
Embodiments of the present invention enable setup synchronization of an end user medical device such as a blood glucose meter. Some embodiments may include a controller including a memory; a transceiver operatively coupled to the controller; and a host computer interface operative to couple the controller to a host computer, wherein the memory is operative to store instructions executable on the controller. The instructions are adapted to cause the controller to scan for an advertising medical device using the transceiver, establish a communications connection with a medical device advertising for synchronization, and transmit synchronization data to a medical device once a communication connection has been estabilshed. Numerous other aspects are disclosed.
H04L 29/08 - Transmission control procedure, e.g. data link level control procedure
A61B 5/00 - Measuring for diagnostic purposes Identification of persons
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value
G16H 40/63 - ICT specially adapted for the management or administration of healthcare resources or facilitiesICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for local operation
H04L 29/06 - Communication control; Communication processing characterised by a protocol
69.
Methods and apparatus for improved medication delivery devices
Embodiments provide systems, methods, and apparatus for a medication delivery device. The device includes a dose selector for selecting an amount of medication to deliver; a first capacitive sensor adjacent the dose selector and operative to detect linear displacement of the dose selector during medication delivery; a screw coupled to the dose selector; a second capacitive sensor adjacent the screw and operative to detect linear displacement of the screw during medication delivery; and a processor coupled to the first and second capacitive sensors and operative to determine an amount of medication actually delivered by the medication delivery device. Numerous other aspects are provided.
A61M 5/50 - Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular wayAccessories therefor, e.g. filling or cleaning devices, arm rests having means for preventing re-use, or for indicating if defective, used, tampered with or unsterile
A61M 5/315 - PistonsPiston-rodsGuiding, blocking or restricting the movement of the rodAppliances on the rod for facilitating dosing
Methods, devices, and systems are disclosed for the determination and logging of risk factor parameters associated with a sample, in association with the measurement of a concentration of an analyte in the sample. The methods, devices, and systems provide for applying an input signal to a sample via an electrode. The input signal has at least one excitation. The methods, devices, and systems further provide for measuring an output signal responsive to the input signal. The methods, devices, and systems further provide for determining a concentration of an analyte within the sample based on the output signal, and determining at least one risk factor parameter associated with at least one species in the sample other than the analyte.
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value
A61B 5/1473 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value using chemical or electrochemical methods, e.g. by polarographic means invasive, e.g. introduced into the body by a catheter
A61B 5/00 - Measuring for diagnostic purposes Identification of persons
G01N 33/49 - Physical analysis of biological material of liquid biological material blood
A sensor system, device, and methods for determining the concentration of an analyte in a sample is described. Input signals including multiple duty cycles of sequential excitation pulses and relaxations are input to the sample. One or more signals output from the sample within 300 ms of the input of an excitation pulse may be correlated with the analyte concentration of the sample to improve the accuracy and/or precision of the analysis. Determining the analyte concentration of the sample from these rapidly measured output values may reduce analysis errors arising from the hematocrit effect, mediator background, and other error sources.
A sensor apparatus for a continuous glucose monitoring system has a sensor housing that includes a first end having a sealing surface configured to seal against an introducer having an insertion shaft, a second end having a sealing surface configured to seal against an insertion shaft cover, and an insertion shaft opening having a width that allows the insertion shaft to travel there through and that extends between the first and second ends. The sensor housing may further include a sensor wire channel that extends between the insertion shaft opening and a sensor wire contact location in an outer surface of the sensor housing. The sensor wire channel and sensor wire contact location may be configured to receive a sensor that extends between the insertion shaft opening and the sensor wire contact location to allow the sensor to make electrical contact to system circuitry. Numerous other aspects are provided.
A test sensor (100) for determining an analyte concentration in a biological fluid comprises a strip including a fluid receiving area (128) and a port-insertion region (126). A first row of optically transparent (132) and non-transparent positions forms a calibration code pattern (130) disposed within a first area of the port-insertion region (126). A second row of optically transparent (142) and non-transparent positions forms a synchronization code pattern (140) disposed within a second area of the port-insertion region (126). The second area is different from the first area. The synchronization code pattern (140) corresponds to the calibration code pattern (130) such that the synchronization code pattern (140) provides synchronization of the serial calibration code pattern (130) during insertion of the port-insertion region (126) into the receiving port of the analyte meter.
G01N 21/78 - Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated by observing the effect on a chemical indicator producing a change of colour
G01N 33/487 - Physical analysis of biological material of liquid biological material
G01N 21/84 - Systems specially adapted for particular applications
G01N 33/49 - Physical analysis of biological material of liquid biological material blood
G01N 21/77 - Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated by observing the effect on a chemical indicator
74.
Systems, methods and apparatus for illuminating edge portions of a face of an electronic device display lens
Embodiments provide systems, methods and apparatus for illuminating a portion of the face of a display lens proximate to and along one or more edges of the display lens. The display lens includes a transparent lens having four edges and a face surface. At least one edge includes an angle relative to the face surface configured to reflect light in the lens out of the face surface. Numerous other aspects are provided.
Devices and methods for determining one or more analyte concentrations in a sample, determining a sample type, and/or accounting for interference species in a sample are disclosed that include intertwining a first input signal, via a first electrode having a reagent, with a second input signal, via a second electrode lacking a reagent, by applying to the sample the first input signal having at least two excitations and a relaxation, and applying to the sample the second input signal having at least two excitations and a relaxation, such that the excitations of the first input signal are nonconcurrent with the excitations of the second input signal. The method further includes measuring a first output signal responsive to the first input signal and a second output signal responsive to the second input signal.
A test meter for analyzing a body fluid sample applied to a test strip includes an outer housing having an opening, an actuator, and a cartridge positioned adjacent the outer housing. The cartridge further includes a dispensing member connected to the actuator, a plurality of stacked test strips biased toward the dispensing member, and a cartridge outer housing that is adjacent at least a portion of the dispensing member. Each time the actuator is actuated, the dispensing member is rotated to cause movement of one test strip from the plurality of stacked test strips through the opening, and another test strip is biased toward the dispensing member.
A system and method is described for rapid charging and power management of a battery for a meter. A charger component is operably associated with the meter and is capable of executing a rapid charge algorithm for a rechargeable battery. The algorithm includes monitoring for a connection to an external power source and implementing a charging routine of a battery at a first charge rate and then at a second charge rate. The second charge rate is lower than the first charge rate. A temperature rise in the rechargeable battery due to the first charge rate has a negligible heat transfer effect on the fluid sample. The meter can also include a power switch for controlling current flow to a battery fuel gauge. The power switch is open when the meter enters into a sleep mode. The state of battery charge is determined after the meter exits the sleep mode.
G08B 21/00 - Alarms responsive to a single specified undesired or abnormal condition and not otherwise provided for
H02J 7/00 - Circuit arrangements for charging or depolarising batteries or for supplying loads from batteries
G01R 31/3842 - Arrangements for monitoring battery or accumulator variables, e.g. SoC combining voltage and current measurements
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value
G01N 33/487 - Physical analysis of biological material of liquid biological material
G01R 31/36 - Arrangements for testing, measuring or monitoring the electrical condition of accumulators or electric batteries, e.g. capacity or state of charge [SoC]
78.
System error compensation of analyte concentration determinations based on pseudo-reference concentration and signal-based anchor parameters
During analyte analysis, errors may be introduced into an analysis by both the biosensor system used to perform the analysis and by errors in the output signal measured by the measurement device of the biosensor. For a reference sample, system error may be determined through the determination of relative error. However, during an analysis of a test sample with the measurement device of the biosensor system, true relative error cannot be known. A pseudo-reference concentration determined during the analysis may be used as a substitute for true relative error. The present invention introduces the determination of a pseudo-reference concentration determined during the analysis as a substitute for the true relative error and uses an anchor parameter to compensate for the system error in the analysis-determined pseudo-reference concentration.
Embodiments of the present invention provide systems, apparatus, and methods for powering electronic devices with low voltage batteries. Embodiments include a circuit including a transistor having a base, an emitter, and a collector; a microcontroller having an output port, a system power terminal, and an input port; a first signal generated from the output port of the microcontroller and coupled to an enable pin of a DC-DC booster; and a second signal generated from the output port of the microcontroller and coupled to the base of the transistor, wherein the second signal is an inverted version of the first signal. The emitter of the transistor is coupled to ground and the collector of the transistor is coupled to the enable pin of the DC-DC booster. Numerous additional aspects are disclosed.
A method for using a meter and a meter (10) adapted to determine an analyte concentration reading, the meter comprising a display (12) adapted to display information to a user of the meter, the display including information directed to a post-meal test-time alarm (22″) that is adapted to remind the user to obtain a post-meal analyte concentration reading, and at least one user input mechanism (15) adapted to allow the user to activate the post-meal test-time alarm.
G01N 1/00 - SamplingPreparing specimens for investigation
G08B 21/24 - Reminder alarms, e.g. anti-loss alarms
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value
A61B 5/00 - Measuring for diagnostic purposes Identification of persons
G06F 19/00 - Digital computing or data processing equipment or methods, specially adapted for specific applications (specially adapted for specific functions G06F 17/00;data processing systems or methods specially adapted for administrative, commercial, financial, managerial, supervisory or forecasting purposes G06Q;healthcare informatics G16H)
G16H 40/63 - ICT specially adapted for the management or administration of healthcare resources or facilitiesICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for local operation
G16H 20/10 - ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients
81.
Device pairing with a dual use piezoelectric acoustic component and vibration sensor
Some embodiments of the present invention include placing a smart device and a peripheral device in pairing mode; detecting at least one pairing motion event with a dual use piezo circuit within the peripheral device; transmitting an indication of the occurrence of the at least one pairing motion event to the smart device; receiving in the smart device the indication of the occurrence of the at least one pairing motion event in satisfaction of at least one pairing condition; and pairing the smart device with the peripheral device in response to satisfaction of the at least one pairing condition. Numerous other aspects are provided.
H04B 7/00 - Radio transmission systems, i.e. using radiation field
H04W 4/80 - Services using short range communication, e.g. near-field communication [NFC], radio-frequency identification [RFID] or low energy communication
H04L 29/06 - Communication control; Communication processing characterised by a protocol
H04W 4/02 - Services making use of location information
H04M 1/72412 - User interfaces specially adapted for cordless or mobile telephones with means for local support of applications that increase the functionality by interfacing with external accessories using two-way short-range wireless interfaces
H04W 4/60 - Subscription-based services using application servers or record carriers, e.g. SIM application toolkits
G06F 3/01 - Input arrangements or combined input and output arrangements for interaction between user and computer
A61B 5/00 - Measuring for diagnostic purposes Identification of persons
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value
H04W 48/10 - Access restriction or access information delivery, e.g. discovery data delivery using broadcasted information
H04W 4/20 - Services signallingAuxiliary data signalling, i.e. transmitting data via a non-traffic channel
H04L 29/08 - Transmission control procedure, e.g. data link level control procedure
H04W 4/06 - Selective distribution of broadcast services, e.g. multimedia broadcast multicast service [MBMS]Services to user groupsOne-way selective calling services
Methods and systems accurately determine an analyte concentration in a fluid sample. In an example embodiment, a receiving port receives a test sensor. The test sensor includes a fluid-receiving area for receiving a fluid sample. The fluid-receiving area contains a reagent that produces a measurable reaction with an analyte in the fluid sample. The test sensor has a test-sensor temperature and the reagent has a reagent temperature. A measurement system measures the reaction between the reagent and the analyte. A temperature-measuring system measures the test sensor temperature when the test sensor is received into the receiving port. A concentration of the analyte in the fluid sample is determined according to the measurement of the reaction and the measurement of the test sensor temperature. A diagnostic system determines an accuracy of the temperature-measuring system. The calculation of the analyte concentration may be adjusted according to the accuracy of temperature-measuring system.
Embodiments provide apparatus, systems, and methods for communicating analyte data and/or related information. In a first aspect, the apparatus includes a transmitter/receiver unit which is configurable as either a transmitter or a receiver. The transmitter/receiver unit may be coupled to an on-body sensor and may be configured as a transmitter, or may be coupled to a management unit and may be configured as a receiver as part of a continuous analyte monitoring system. Analyte data communication systems and methods are provided, as are other aspects.
A61B 5/00 - Measuring for diagnostic purposes Identification of persons
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value
A61B 5/1473 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value using chemical or electrochemical methods, e.g. by polarographic means invasive, e.g. introduced into the body by a catheter
A biosensor system, method and apparatus are provided for implementing threshold based correction functions for biosensors. A primary measurement of an analyte value is obtained. A secondary measurement of a secondary effect is obtained and is compared with a threshold value. A correction function is identified responsive to the compared values. The correction function is applied to the primary measurement of the analyte value to provide a corrected analyte value. The correction method uses correction curves that are provided to correct for an interference effect. The correction curves can be linear or non-linear. The correction method provides different correction functions above and below the threshold value. The correction functions may be dependent or independent of the primary measurement that is being corrected. The correction functions may be either linear or nonlinear.
C12Q 1/00 - Measuring or testing processes involving enzymes, nucleic acids or microorganismsCompositions thereforProcesses of preparing such compositions
A biosensor system determines an analyte concentration of a biological sample using an electrochemical process without Cottrell decay. The biosensor system generates an output signal having a transient decay, where the output signal is not inversely proportional to the square root of the time. The transient decay is greater or less than the −0.5 decay constant of a Cottrell decay. The transient decay may result from a relatively short incubation period, relatively small sample reservoir volumes, relatively small distances between electrode surfaces and the lid of the sensor strip, and/or relatively short excitations in relation to the average initial thickness of the reagent layer. The biosensor system determines the analyte concentration from the output signal having a transient decay.
C12Q 1/54 - Measuring or testing processes involving enzymes, nucleic acids or microorganismsCompositions thereforProcesses of preparing such compositions involving glucose or galactose
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value
A61B 5/1486 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value using chemical or electrochemical methods, e.g. by polarographic means using enzyme electrodes, e.g. with immobilised oxidase
C12Q 1/00 - Measuring or testing processes involving enzymes, nucleic acids or microorganismsCompositions thereforProcesses of preparing such compositions
A61B 5/1455 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value using optical sensors, e.g. spectral photometrical oximeters
A61B 5/1495 - Calibrating or testing in vivo probes
86.
System and apparatus for determining ambient temperatures for a fluid analyte system
A system and method for rapidly determining ambient temperature in a fluid-analyte meter. The meter includes a housing defining an interior space and an area for receiving a fluid sample. A processor and a first temperature sensor are disposed within the interior space of said the housing. A second temperature sensor is disposed on the housing. One or more processors are configured to determine a first temperature value from temperature data received from the first temperature sensor. The processor(s) are also configured to apply a variable current to a temperature-adjustment source such that the second temperature sensor is adjusted to a predetermined steady-state temperature value different from the first temperature value. The processor(s) are further configured to determine an ambient temperature of an exterior space of the housing based on the applied variable current, pre-determined steady-state temperature, and received first temperature values.
Embodiments of the invention provide apparatus, systems, and methods wherein pre-event and post-event analyte concentration readings associated with an event are collected and processed to determine a numerical delta. The numerical delta may be displayed on a visual display to aid in a ready determination of the affect that the event (alone or in combination with medication and/or insulin dosages) had on the analyte concentration levels. Medication and/or insulin dosages may be displayed alongside the numerical delta to gauge immediate relationships between numerical delta, dosage, and/or an associated event. Apparatus and systems for calculating and displaying the numerical delta are described, as are other aspects.
Some embodiments of the present invention include pairing two wireless devices by placing at least one of two devices in a pairing mode; performing at least one pairing motion event with at least one of the wireless devices to satisfy at least one pairing condition; detecting satisfaction of the at least one pairing condition; and pairing the two wireless devices in response to detecting satisfaction of the at least one pairing condition. Numerous other aspects are provided.
H04W 4/80 - Services using short range communication, e.g. near-field communication [NFC], radio-frequency identification [RFID] or low energy communication
H04L 29/06 - Communication control; Communication processing characterised by a protocol
H04W 4/02 - Services making use of location information
H04W 4/60 - Subscription-based services using application servers or record carriers, e.g. SIM application toolkits
G06F 3/01 - Input arrangements or combined input and output arrangements for interaction between user and computer
A61B 5/00 - Measuring for diagnostic purposes Identification of persons
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value
H04W 48/10 - Access restriction or access information delivery, e.g. discovery data delivery using broadcasted information
H04W 4/20 - Services signallingAuxiliary data signalling, i.e. transmitting data via a non-traffic channel
H04L 29/08 - Transmission control procedure, e.g. data link level control procedure
H04W 4/06 - Selective distribution of broadcast services, e.g. multimedia broadcast multicast service [MBMS]Services to user groupsOne-way selective calling services
A device and system for automatic handling of a sensor strip by a part of a meter that includes a sensor strip having a first section, a second section, and an intermediate section. The sensor strip includes at least a first opening about a first end thereof and a second opening about a second end thereof. A meter part includes a pair of pivoting catches configured to engage and grasp a sensor strip from a container containing a plurality of sensor strips. The sensor strip may thus be removed from a container for testing without need for manual handling of the strip by a user.
G01N 33/00 - Investigating or analysing materials by specific methods not covered by groups
G01N 33/487 - Physical analysis of biological material of liquid biological material
C12Q 1/54 - Measuring or testing processes involving enzymes, nucleic acids or microorganismsCompositions thereforProcesses of preparing such compositions involving glucose or galactose
C12Q 1/00 - Measuring or testing processes involving enzymes, nucleic acids or microorganismsCompositions thereforProcesses of preparing such compositions
G01N 33/52 - Use of compounds or compositions for colorimetric, spectrophotometric or fluorometric investigation, e.g. use of reagent paper
G01N 33/543 - ImmunoassayBiospecific binding assayMaterials therefor with an insoluble carrier for immobilising immunochemicals
G01N 21/84 - Systems specially adapted for particular applications
90.
Washable analyte meters, sealed connectors, and methods of manufacturing and using same
An analyte meter to detect an analyte concentration level in a bio-fluid sample may be cleaned and disinfected with a cleaning liquid without harming electrical and internal meter components. In some embodiments, the analyte meter is washable and immersable and may include a sealed sensor connector, sealed battery connector, and possibly a sealed USB connector that may be subjected to a cleaning liquid without the liquid entering an internal chamber of the analyte meter and contacting internal electronic components. In some embodiments, a sealed display screen and sealed keypad are provided such that liquids are prevented from entering the internal chamber. Manufacturing methods and systems utilizing the analyte sensors are provided, as are numerous other aspects.
H01R 13/52 - Dustproof, splashproof, drip-proof, waterproof, or flameproof cases
B08B 3/04 - Cleaning involving contact with liquid
H01R 43/14 - Maintenance of current collectors, e.g. reshaping of brushes, cleaning of commutators
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value
A61B 5/1468 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value using chemical or electrochemical methods, e.g. by polarographic means
91.
Test sensor cartridges and sensor-dispensing instruments
The cartridge comprises a housing, a plurality of test sensors, a mechanical mechanism, and a pusher assembly. The housing forms at least one opening therethrough. The plurality of test sensors is stacked in the housing. The plurality of test sensors is adapted to assist in testing at least one analyte. The mechanical mechanism is adapted to urge the plurality of test sensors in a first direction. One of the plurality of test sensors is positioned for extraction from the cartridge. The pusher assembly is adapted to push one of the plurality of test sensors from the cartridge. The pusher assembly includes a ferromagnetic material or a magnet.
A system and method is described for rapid charging and power management of a battery for a meter. A charger component is operably associated with the meter and is capable of executing a rapid charge algorithm for a rechargeable battery. The algorithm includes monitoring for a connection to an external power source and implementing a charging routine of a battery at a first charge rate and then at a second charge rate. The second charge rate is lower than the first charge rate. A temperature rise in the rechargeable battery due to the first charge rate has a negligible heat transfer effect on the fluid sample. The meter can also include a power switch for controlling current flow to a battery fuel gauge. The power switch is open when the meter enters into a sleep mode. The state of battery charge is determined after the meter exits the sleep mode.
G08B 21/00 - Alarms responsive to a single specified undesired or abnormal condition and not otherwise provided for
H02J 7/00 - Circuit arrangements for charging or depolarising batteries or for supplying loads from batteries
G01R 31/3842 - Arrangements for monitoring battery or accumulator variables, e.g. SoC combining voltage and current measurements
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value
G01N 33/487 - Physical analysis of biological material of liquid biological material
G01R 31/36 - Arrangements for testing, measuring or monitoring the electrical condition of accumulators or electric batteries, e.g. capacity or state of charge [SoC]
93.
Replaceable multistrip cartridge and biosenser meter
A blood glucose monitor includes a can, a replaceable sensor cartridge that includes a frame, an upper spring disposed between the frame and the can, a case for housing the can and sealing the frame, a lower spring disposed between the can and the case, and a meter housing for sealing an upper portion of the frame. The can is capable of accepting the replaceable sensor cartridge. The frame of the removable cartridge has at least at least two walls defining a chamber for accepting a plurality of biosensors, and a bottom portion defining an opening and at least one sealing flange. The frame can further include a desiccant material capable of reducing humidity within the frame. The frame may be dimensioned such that an interference fit constrains the plurality of biosensors prior to inserting the frame within a blood glucose monitor.
In some embodiments, a sensor assembly for a continuous glucose monitoring system is provided that includes (1) a sensor carrier having a sensor unit receiving area and an electronics receiving area, the electronics receiving area including a substrate; (2) a sensor unit having a sterilized region, the sterilized region including at least a portion of a sensor and an introducer; and (3) electronics for the continuous glucose monitoring system. The sensor unit is positioned within the sensor unit receiving area of the sensor carrier and the electronics are positioned on the substrate within the electronics receiving area of the sensor carrier so as to form a sensor assembly having the sensor electrically connected to the substrate of the electronics receiving area while maintaining sterilization of the sterilized region of the sensor unit. Numerous other aspects are provided.
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value
A61B 5/00 - Measuring for diagnostic purposes Identification of persons
A61B 5/1486 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value using chemical or electrochemical methods, e.g. by polarographic means using enzyme electrodes, e.g. with immobilised oxidase
95.
DIABETES MANAGEMENT SYSTEMS, METHODS AND APPARATUS FOR USER REMINDERS, PATTERN RECOGNITION, AND INTERFACES
Systems, methods, and apparatus for diabetes management include a portable diabetes management system (DMS) device. The DMS device includes a processor, a data storage device, a touchscreen display, and wireless communications facilities. An interactive display screen configured to be displayed on the touchscreen display lists a selectable subset of a plurality of different detected patterns related to blood glucose measurement data received by the DMS device. The patterns are detected based on a plurality of algorithms executable on the processor. A subset of detected patterns is determined based upon a frequency with which the patterns are detected and a priority is assigned to the detected patterns. Numerous other aspects are provided.
G16H 20/17 - ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients delivered via infusion or injection
G16H 50/20 - ICT specially adapted for medical diagnosis, medical simulation or medical data miningICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for computer-aided diagnosis, e.g. based on medical expert systems
G16H 40/63 - ICT specially adapted for the management or administration of healthcare resources or facilitiesICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for local operation
G06F 3/0484 - Interaction techniques based on graphical user interfaces [GUI] for the control of specific functions or operations, e.g. selecting or manipulating an object, an image or a displayed text element, setting a parameter value or selecting a range
A biosensor system determines analyte concentration from analytic and/or secondary output signals. The biosensor system adjusts a correlation for determining analyte concentrations from output signals with one or more index functions extracted from the output signals. The index functions determine at least one slope deviation or normalized slope deviation from one or more error parameters. The slope-adjusted correlation between analyte concentrations and output signals may be used to determine analyte concentrations having improved accuracy and/or precision from output signals including components attributable to bias.
Apparatus for illuminating one or more components of an electronic device having a visual display (e.g., a backlit display), such as one or more keys of keyboards, one or more interface ports, or one or more external surfaces are disclosed. In one or more embodiments, a component illumination apparatus has a visual display and a light guide optically coupled to the visual display and that is adapted to illuminate one or more components external to the visual display. Methods of component illumination and illumination systems are described, as are other embodiments.
Embodiments of the invention provide apparatus, systems, and methods wherein pre-event and post-event analyte concentration readings associated with an event are collected and processed to determine a numerical delta. The numerical delta may be displayed on a visual display to aid in a ready determination of the affect that the event (alone or in combination with medication and/or insulin dosages) had on the analyte concentration levels. Medication and/or insulin dosages may be displayed alongside the numerical delta to gauge immediate relationships between numerical delta, dosage, and/or an associated event. Apparatus and systems for calculating and displaying the numerical delta are described, as are other aspects.
A biosensor has an underfill detection system that determines whether a sample of a biological fluid is large enough for an analysis of one or more analytes. The underfill detection system applies an excitation signal to the sample, which generates an output signal in response to the excitation signal. The underfill detection system switches the amplitude of the excitation signal. The transition of the excitation signal to a different amplitude changes the output signal when the sample is not large enough for an accurate and/or precise analysis. The underfill detection system measures and compares the output signal with one or more underfill thresholds to determine whether an underfill condition exists.
A non-leaching mediator may include a polymer having a polymeric backbone, and a plurality of phenothiazine groups bonded to the polymeric backbone. The plurality of phenothiazine groups may include at least one of a phenothiazine group having the general formula (IV):
and salts thereof, where n is about 9 and “R” represents the polymeric backbone to which the phenothiazine group is bonded, and a phenothiazine group having the general formula (V):
and salts thereof, where n is about 9 and “R” represents the polymeric backbone to which the phenothiazine group is bonded.
C07D 279/08 - 1,3-ThiazinesHydrogenated 1,3-thiazines condensed with carbocyclic rings or ring systems
C08F 8/30 - Introducing nitrogen atoms or nitrogen-containing groups
C08G 59/40 - Macromolecules obtained by polymerising compounds containing more than one epoxy group per molecule using curing agents or catalysts which react with the epoxy groups characterised by the curing agents used
C12Q 1/00 - Measuring or testing processes involving enzymes, nucleic acids or microorganismsCompositions thereforProcesses of preparing such compositions
C07D 417/14 - Heterocyclic compounds containing two or more hetero rings, at least one ring having nitrogen and sulfur atoms as the only ring hetero atoms, not provided for by group containing three or more hetero rings
patents
