A dose monitoring system for an injection pen includes a dose detection assembly and an injection detection assembly. The dose detection assembly includes a housing securable to a body of the injection pen over a dose display window, an optical sensor assembly for determining an amount of movement of a dose indicator surface within the dose display window, and a processor arranged within the housing. The injection detection assembly includes a housing securable to a dose knob of the injection pen, an injection sensor for detecting a force or touch applied to the dose knob, and a transmitter to communicate injection information when the force or touch is applied. The amount of medication injected is determined based on the amount of movement of the dose indicator surface within the dose display window when the force or touch is applied to the dose knob.
The present disclosure provides analyte sensors comprising a sensing layer disposed upon a surface of a first working electrode, wherein the sensing layer comprises an NAD(P)-dependent enzyme and a supply of NAD(P); and a multilayered membrane that overcoats at least a part of the sensing layer and is permeable to an analyte, wherein the membrane comprises at least one layer of negatively charged polymer. The present disclosure also provides methods of using such analyte sensors for detecting one or more analytes preset in a biological sample and methods of manufacturing the analyte sensors.
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 27/31 - Half-cells with permeable membranes, e.g. semi-porous or perm-selective membranes
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
The present disclosure provides analyte sensors comprising a first working electrode, a sensing layer disposed upon a surface of the first working electrode, and a highly permeable membrane that overcoats at least a part of the sensing layer and that is permeable to an analyte, wherein the highly permeable membrane comprises a copolymer of poly(N-vinylimidazole) and poly(N-isopropylacrylamide), and wherein the analyte sensor shows a sensitivity of at least 100 nA/mM to the analyte. The present disclosure also provides methods of using such analyte sensors for detecting one or more analytes preset in a biological sample and methods of manufacturing the analyte sensors.
A dose monitoring system for an injection pen includes a dose detection assembly and an injection detection assembly. The dose detection assembly includes a housing securable to a body of the injection pen over a dose display window, an optical sensor assembly for determining an amount of movement of a dose indicator surface within the dose display window, and a processor arranged within the housing. The injection detection assembly includes a housing securable to a dose knob of the injection pen, an injection sensor for detecting a force or touch applied to the dose knob, and a transmitter to communicate injection information when the force or touch is applied. The amount of medication injected is determined based on the amount of movement of the dose indicator surface within the dose display window when the force or touch is applied to the dose knob.
Analyte sensors are being increasingly employed for monitoring various analytes in vivo. Analyte sensors may feature enhancements to address signals obtained from interferent species. Some analyte sensors may comprise a substrate having a planar surface, a working electrode disposed on the surface of the substrate and comprising an active area, the active area having an analyte-responsive enzyme, a reference electrode disposed on the surface of the substrate and separated by a distance from the working electrode, and at least one barrier disposed between the working electrode and the reference electrode, wherein the barrier includes an ablated zone and is configured to electrically isolate the working electrode from the reference electrode, and wherein the working electrode and the reference electrode are electrically isolated from each other on the surface of the substrate.
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
Methods, devices, and systems includes an analyte sensor configured to monitor an analyte level, where at least a portion of the analyte sensor is configured to be positioned in contact with a bodily fluid of a subject. The analyte sensor may also include a communication module. A first receiver device may be wirelessly coupled to the communication module of the analyte sensor and configured to receive analyte data from the analyte sensor. One or more second receiver devices may be wirelessly coupled to the communication module of the analyte sensor. The analyte sensor, the first receiver device, and the one or more second receiver devices may be arranged in a star network topology with the analyte sensor being at a center of the star network topology.
G16H 15/00 - ICT specially adapted for medical reports, e.g. generation or transmission thereof
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 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 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
H04L 67/00 - Network arrangements or protocols for supporting network services or applications
An applicator may include a housing made of a uniform synthetic material. The applicator may include a sharp carrier coupled to a sharp, the sharp carrier also being made of the uniform synthetic material. The applicator may include a retraction spring that is also made of the uniform synthetic material. The applicator may include a sheath that is also made of the uniform synthetic material. The applicator may include a firing pin that is also made of the uniform synthetic material. The applicator may include a drive spring made that is also made of the uniform synthetic material. The applicator may include a puck carrier that is also made of the uniform synthetic material. The applicator may include the glucose sensor.
Methods, devices, and systems includes an analyte sensor configured to monitor an analyte level, where at least a portion of the analyte sensor is configured to be positioned in contact with a bodily fluid of a subject. The analyte sensor may also include a communication module. A first receiver device may be wirelessly coupled to the communication module of the analyte sensor and configured to receive analyte data from the analyte sensor. One or more second receiver devices may be wirelessly coupled to the communication module of the analyte sensor. The analyte sensor, the first receiver device, and the one or more second receiver devices may be arranged in a star network topology with the analyte sensor being at a center of the star network topology.
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
A63B 24/00 - Electric or electronic controls for exercising apparatus of groups
H04L 67/12 - Protocols specially adapted for proprietary or special-purpose networking environments, e.g. medical networks, sensor networks, networks in vehicles or remote metering networks
12.
METHODS, DEVICES, AND SYSTEMS FOR ADJUSTING LABORATORY HBA1C VALUES
A method for determining a time for obtaining laboratory glycated hemoglobin measurements can include receiving at least one glucose level for a subject during at least one time period, receiving a first measured glycated hemoglobin (HbAlc) level for the subject corresponding to a beginning of a first time period of the at least one time period, determining a first calculated glycated hemoglobin (HbAlc) level corresponding to the first time period, determining for the first time period a second calculated glycated hemoglobin (HbAlc) level using a first offset value, determining for the first time period a third calculated glycated hemoglobin (HbAlc) level using a second offset value, calculating a first difference between the first calculated glycated hemoglobin (HbAlc) level and the second calculated glycated hemoglobin (HbAlc) level, calculating a second difference between the first calculated glycated hemoglobin (HbAlc) level and the third calculated glycated hemoglobin (HbAlc) level, and generating an alert notification to obtain a second measured glycated hemoglobin (HbAlc) level for the subject in response to a determination that the first difference or the second difference is above a first predetermined threshold value.
A system includes an analyte measurement system and a software application operatively coupled to the analyte measurement system. The analyte measurement system is configured to measure a ketone level in the bodily fluid of a patient. The application is configured to display at least one of (1) a current ketone level and an indicator of a current ketone trend, (2) a ketone trend graph, and (3) a total amount of time that the ketone levels are above at least one predetermined threshold level. The application is also configured to determine if the current ketone level is above the at least one predetermined threshold level, and in response to determining that the current ketone level is above the at least one predetermined threshold level, output an alarm, wherein the alarm is outputted periodically while the current ketone level is above the at least one predetermined threshold level.
Presented herein is a handheld analyte measurement device. The analyte measurement device includes one or more software applications to help the user manager their diabetes. Embodiments and descriptions of the various applications are provided below in conjunction with the handheld analyte measurement device.
G16H 80/00 - ICT specially adapted for facilitating communication between medical practitioners or patients, e.g. for collaborative diagnosis, therapy or health monitoring
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value
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 15/00 - ICT specially adapted for medical reports, e.g. generation or transmission thereof
G16H 20/00 - ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
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
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
15.
SYSTEMS, DEVICES, AND METHODS FOR ANALYTE MONITORING AND BENEFITS THEREOF
A method of treatment of a type 2 diabetic patient includes selecting a type 2 diabetic patient having a predetermined comorbidity for treatment, initiating a continuous glucose monitor regimen for the selected type 2 diabetic patient, wherein after six months of initiation of the continuous glucose monitor regimen, a rate of hospitalization for a predetermined diagnostic category of the selected patient having the predetermined comorbidity is reduced by at least 12% relative to an average rate of hospitalization for the predetermined diagnostic category of selected patients having the predetermined comorbidity without the continuous glucose monitor regimen.
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
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
16.
METHOD FOR MANAGING A PHYSICAL LAYER UTILIZED DURING A WIRELESS CONNECTION WITH MEDICAL DEVICES
Techniques include a medical device including processors, one or more sensors configured to generate signals corresponding to one or more physiological signals detected in a body of a user, a communication module configured to communicate wirelessly with a receiving device using a communication protocol capable of data transmission or reception at multiple data rates, and memories including instructions to cause the one or more processors to transmit information to the receiving device indicating that the communication module is configured to communicate using the multiple data rates; determine one of the data rates to be utilized for at least one of data transmission or reception during a communication session with the receiving device; initialize the communication session with the receiving device using the determined data rate; and transmit, via to the receiving device and using the determined data rate, communications based on the signals corresponding to the physiological signals.
H04L 67/12 - Protocols specially adapted for proprietary or special-purpose networking environments, e.g. medical networks, sensor networks, networks in vehicles or remote metering networks
A61N 1/372 - Arrangements in connection with the implantation of stimulators
A61N 1/375 - Constructional arrangements, e.g. casings
The present disclosure describes lactate-responsive sensors having first and second lactate-responsive sensing areas, sensing systems incorporating the lactate-responsive sensor, and methods of using the same that for continuously monitoring lactate levels and determining variance between lactate concentrations derived from signals independently obtained from the first and second lactate-responsive areas.
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
18.
DEPLOYMENT AND USE OF A CONTINUOUS ANALYTE MONITORING SYSTEM FOR IMPROVED PATIENT TREATMENT
Disclosed herein are system, method, and computer program product embodiments for improving detection and treatment of patient conditions based on continuous analyte data. The disclosed techniques utilize analyte data, such as lactate, glucose, and creatinine, provided from a continuous analyte sensor to predict patient outcomes. The prediction may also take into account other medical information associated with the patient, such as patient vital signs and medical history. The disclosed system allows for early and non-invasive prediction of patient outcomes in various settings including a hospital setting, a home setting, disease (e.g., heart failure, sepsis) detection, and high risk surgery monitoring. The disclosed system also is configured to monitor patient conditions and generating alerts and/or notifications based on the predicted patient outcomes to provide preemptive treatment of patient conditions.
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 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 80/00 - ICT specially adapted for facilitating communication between medical practitioners or patients, e.g. for collaborative diagnosis, therapy or health monitoring
19.
DEPLOYMENT AND USE OF A CONTINUOUS ANALYTE MONITORING SYSTEM FOR IMPROVED PATIENT TREATMENT
Disclosed herein are system, method, and computer program product embodiments for improving detection and treatment of patient conditions based on continuous analyte data. The disclosed techniques utilize analyte data, such as lactate, glucose, and creatinine, provided from a continuous analyte sensor to predict patient outcomes. The prediction may also take into account other medical information associated with the patient, such as patient vital signs and medical history. The disclosed system allows for early and non-invasive prediction of patient outcomes in various settings including a hospital setting, a home setting, disease (e.g., heart failure, sepsis) detection, and high risk surgery monitoring. The disclosed system also is configured to monitor patient conditions and generating alerts and/or notifications based on the predicted patient outcomes to provide preemptive treatment of patient conditions.
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
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 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 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
20.
ANALYTE MONITORING SYSTEMS AND METHODS FOR MONITORING MULTIPLE ANALYTES
An analyte monitoring assembly for monitoring one or more analytes in a bodily fluid of a user includes a housing configured to be mounted on a body of a user and sensor electronics arranged within the housing. An analyte sensor includes a body portion coupled to the sensor electronics and arranged within the housing and one or more tail portions configured to be positioned in the body of the user. The analyte sensor further includes a first electrode comprising a first active area for detecting a first analyte, and a second electrode comprising a second active area for detecting a second analyte.
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
21.
SENSOR FOR DETECTING GLUCOSE AND LACTATE AND METHODS FOR DETERMINING AEROBIC AND ANAEROBIC THRESHOLDS
The present disclosure describes lactate-responsive sensors, sensing systems incorporating a lactate-responsive sensor, and methods of use thereof that would be beneficial for continuously monitoring lactate levels and determining lactate thresholds (both aerobic and anaerobic thresholds). The present disclosure also relates to an analyte sensor for continuously detecting glucose and lactate levels.
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
22.
ANALYTE MONITORING SYSTEMS AND METHODS FOR MONITORING MULTIPLE ANALYTES
An analyte monitoring assembly for monitoring one or more analytes in a bodily fluid of a user includes a housing configured to be mounted on a body of a user and sensor electronics arranged within the housing. An analyte sensor includes a body portion coupled to the sensor electronics and arranged within the housing and one or more tail portions configured to be positioned in the body of the user. The analyte sensor further includes a first electrode comprising a first active area for detecting a first analyte, and a second electrode comprising a second active area for detecting a second analyte.
A lactate-responsive enzyme may form the basis for lactate detection and quantification using an electrochemical analyte sensor. Various features may be incorporated within an analyte sensor containing a lactate-responsive enzyme, particularly lactate oxidase, to improve sensitivity and response stability of the analyte sensor. Such analyte sensors may comprise: a working electrode having an active area disposed thereon, and a mass transport limiting membrane overcoating at least the active area upon the working electrode. The active area comprises at least a polymer, an albumin, and a lactate-responsive enzyme that is covalently bonded to the polymer. The mass transport limiting membrane may comprise at least a crosslinked polyvinylpyridine homopolymer or copolymer. The analyte sensors may determine a lactate concentration in a biological fluid, particularly in vivo, which may be correlated to various physiological conditions.
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
An analyte sensor including an antiglycolytic agent or a precursor thereof and a chelating agent that stabilizes the antiglycolytic agent positioned proximate to the working electrode of the sensor. Also provided are systems and methods of using the electrochemical analyte sensors in analyte monitoring.
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 5/1477 - 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 5/1486 - 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
26.
SYSTEMS, DEVICES, AND METHODS FOR ANALYTE MONITORING
A glucose monitoring system comprising a sensor control device comprising an analyte sensor coupled with sensor electronics, the sensor control device configured to transmit data indicative of an analyte level of a subject, and a reader device. The reader device comprises a wireless communication circuitry configured to receive the data indicative of the analyte level and a glycated hemoglobin level for the subject, a non-transitory memory, and at least one processor communicatively coupled to the non-transitory memory and the analyte sensor and configured: calculate a plurality of personalized glucose metrics for the subject using at least one physiological parameter and at least one of the received data indicative of the analyte level or the received glycated hemoglobin level, and a display, on a display of the reader device, a report comprising a plurality of interfaces including at least two or more of the received data indicative of the analyte level, the received glycated hemoglobin level, or the calculated plurality of personalized glucose metrics, wherein the plurality of interfaces comprising the report are based on a user type.
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
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 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
27.
PREDICTING ANALYTE LEVELS BASED ON INTERMITTENT SENSOR DATA
Techniques for predicting analyte levels based on intermittent sensor data are disclosed. First sensor data is acquired from an analyte sensor. The first sensor data reflects analyte levels of a user who is wearing the analyte sensor. The first sensor data is collected over a first time period. Later, a determination is made as to whether data is still being acquired from the analyte sensor. As a result of determining that data is no longer being acquired from the analyte sensor, the first sensor data is classified as intermittent analyte data. The intermittent analyte data is then used to generate predicted analyte level data for the user during a second time period that is subsequent to the first time period. The predicted analyte level data is reflective of the intermittent analyte data.
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 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 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
A61B 5/00 - Measuring for diagnostic purposes Identification of persons
28.
Display screen or portion thereof with graphical user interface
Techniques for predicting analyte levels based on intermittent sensor data are disclosed. First sensor data is acquired from an analyte sensor. The first sensor data reflects analyte levels of a user who is wearing the analyte sensor. The first sensor data is collected over a first time period. Later, a determination is made as to whether data is still being acquired from the analyte sensor. As a result of determining that data is no longer being acquired from the analyte sensor, the first sensor data is classified as intermittent analyte data. The intermittent analyte data is then used to generate predicted analyte level data for the user during a second time period that is subsequent to the first time period. The predicted analyte level data is reflective of the intermittent analyte data.
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
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
30.
BACKGROUND INTERFERENCE MITIGATION FOR HIGH SENSITIVITY KETONE SENSING BY ACCUMULATION MODE SENSING AT LOW WORKING ELECTRODE POTENTIAL
The present disclosure relates to a method of improving the sensitivity of sensing ketones that includes providing i) a ketone sensing electrode comprising a ketone-responsive enzyme and a redox mediator; and ii) a background sensing electrode comprising a redox mediator and no ketone-responsive enzyme and applying a potential less than +40 mV to provide a steady state. The ketone sensing electrode and background sensing electrode can be simultaneously or sequentially disconnected from the circuit to allow the charge to accumulate for a set period of time. After sufficient charge has been built up, both electrodes can be reconnected to the circuit. The ketone signal can be measured by subtracting a signal obtained from the background sensing electrode from a signal obtained from the ketone sensing electrode. The present disclosure further relates to a ketone sensor comprising a first sensing electrode that senses ketone and a second sensing electrode that senses the background.
C12Q 1/00 - Measuring or testing processes involving enzymes, nucleic acids or microorganismsCompositions thereforProcesses of preparing such compositions
C12Q 1/32 - Measuring or testing processes involving enzymes, nucleic acids or microorganismsCompositions thereforProcesses of preparing such compositions involving oxidoreductase involving dehydrogenase
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value
The present disclosure relates to a creatinine sensor comprising a first working electrode, a creatinine sensing layer on the first working electrode comprising a redox mediator, creatinine amidohydrolase, creatine amidinohydrolase, and sarcosine oxidase, and a hydrophilic polyurethane membrane overcoating the creatinine sensing layer. The creatinine sensor can further comprise a background sensing electrode that does not detect creatinine. The present disclosure further relates to a method for sensing creatinine comprising exposing the creatinine sensor with a background sensing electrode to a fluid; applying a potential to the first and second working electrodes; obtaining a first signal from the first working electrode proportional to a concentration of creatinine and background interference in the fluid; obtaining a second signal from the second working electrode proportional to a concentration of background interference in the fluid; and determining the concentration of creatinine in the fluid by subtracting the second signal from the first signal.
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
The present disclosure relates to a creatinine sensor comprising a first working electrode, a creatinine sensing layer on the first working electrode comprising a redox mediator, creatinine amidohydrolase, creatine amidinohydrolase, and sarcosine oxidase, and a hydrophilic polyurethane membrane overcoating the creatinine sensing layer. The creatinine sensor can further comprise a background sensing electrode that does not detect creatinine. The present disclosure further relates to a method for sensing creatinine comprising exposing the creatinine sensor with a background sensing electrode to a fluid; applying a potential to the first and second working electrodes; obtaining a first signal from the first working electrode proportional to a concentration of creatinine and background interference in the fluid; obtaining a second signal from the second working electrode proportional to a concentration of background interference in the fluid; and determining the concentration of creatinine in the fluid by subtracting the second signal from the first signal.
C12Q 1/00 - Measuring or testing processes involving enzymes, nucleic acids or microorganismsCompositions thereforProcesses of preparing such compositions
G01N 33/70 - Chemical analysis of biological material, e.g. blood, urineTesting involving biospecific ligand binding methodsImmunological testing involving creatine or creatinine
33.
METHODS AND APPARATUSES FOR PROVIDING ADVERSE CONDITION NOTIFICATION WITH ENHANCED WIRELESS COMMUNICATION RANGE IN ANALYTE MONITORING SYSTEMS
Methods, devices, systems, and kits are provided that buffer the time spaced glucose signals in a memory, and when a request for real time glucose level information is detected, transmit the buffered glucose signals and real time monitored glucose level information to a remotely located device, process a subset of the received glucose signals to identify a predetermined number of consecutive glucose data points indicating an adverse condition such as an impending hypoglycemic condition, confirm the adverse condition based on comparison of the predetermined number of consecutive glucose data points to a stored glucose data profile associated with the adverse condition, where confirming the adverse condition includes generating a notification signal when the impending hypoglycemic condition is confirmed, and activate a radio frequency (RF) communication module to wirelessly transmit the generated notification signal to the remotely located device only when the notification signal is generated.
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 40/20 - 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 or administration of healthcare resources or facilities, e.g. managing hospital staff or surgery rooms
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 50/20 - 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
34.
SYSTEMS, DEVICES, AND METHODS OF USING BLOCKCHAIN FOR TRACKING PATIENT IDENTIFICATION
A system for bi-directional communication of patient data can include a first database having a first record including first data associated with a personal identification of a patient, a second database having a second record including second data associated with a user identification of the patient; and one or more processors configured to: pair the first data and the second data based upon a shared data item contained in the first record and the second record, and display a combination of the first data paired with the second data. A blockchain is used to paid the first and second records associated with different user identifications of the same patient.
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 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
Methods and devices to monitor an analyte in body fluid are provided. Embodiments include continuous or discrete acquisition of analyte related data from a transcutaneously positioned in vivo analyte sensor automatically or upon request from a user. The in vivo analyte sensor is coupled to an electronics unit holding a memory with instruction to cause processing circuitry to initiate a predetermined time period that is longer than a predetermined life of the sensor, during the predetermined time period, convert signals from the sensor related to glucose to respective corresponding glucose levels, without relying on any post-manufacture independent analyte measurements from a reference device, and at the expiration of the predetermined time period, disable, deactivate, or cease use of one or more feature.
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
G01N 33/487 - Physical analysis of biological material of liquid biological material
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
36.
Display screen or portion thereof with graphical user interface
Improved digital interfaces and graphical user interfaces for analyte monitoring systems are provided. For example, disclosed herein are various embodiments of methods, systems, and interfaces for a self-check questionnaire. In addition, various embodiments of interfaces for a treatment decision guide and related knowledge check are described.
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 40/63 - 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 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
44.
Display screen or portion thereof with graphical user interface
A glucose monitoring system includes a sensor control device comprising an analyte sensor coupled with sensor electronics, the sensor control device configured to transmit data indicative of an analyte level, and a reader device comprising a wireless communication circuitry configured to receive the data indicative of the analyte level, and one or more processors coupled with a memory. The memory is configured to store instructions that, when executed by the one or more processors, cause the one or more processors to: determine a frequency of interaction over a first time period based on one or more instances of user operation of the reader device, and output a first notification if the determined frequency of interaction is below a predetermined target level of interaction and output a second notification if the determined frequency of interaction is above the predetermined target level of interaction, wherein below the predetermined target level of interaction, an increase in the determined frequency of interaction corresponds to a first improvement in a metabolic parameter, and above the predetermined target level of interaction, an increase in the determined frequency of interaction corresponds to a second improvement in the metabolic parameter.
Improved alarms for analyte monitoring systems are provided. For example, disclosed herein are various embodiments of methods, systems, and interfaces for long hyperglycemic alerts or pre-alerts. In addition, various embodiments of methods, systems, and interfaces for modified high glucose alerts, which predict if the high glucose episode is associated with a recently administered medication dose are described. Also, systems that include both high glucose alerts and long hyperglycemic alert options are described, in addition to enabling and disabling or suppressing certain alerts under various conditions.
Improved graphical user interfaces and wireless communication features for analyte monitoring software applications are provided. For example, disclosed herein are various embodiments of methods, systems, and interfaces for displaying data indicative of an analyte level for an analyte monitoring software application capable of receiving data according to more than one wireless communication protocol.
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
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
H04W 4/80 - Services using short range communication, e.g. near-field communication [NFC], radio-frequency identification [RFID] or low energy communication
Improved alarms for analyte monitoring systems are provided. For example, disclosed herein are various embodiments of methods, systems, and interfaces for long hyperglycemic alerts or pre-alerts. In addition, various embodiments of methods, systems, and interfaces for modified high glucose alerts, which predict if the high glucose episode is associated with a recently administered medication dose are described. Also, systems that include both high glucose alerts and long hyperglycemic alert options are described, in addition to enabling and disabling or suppressing certain alerts under various conditions.
In one embodiment, a method for secured communication between a medical sensor and a computing device includes receiving, by the medical sensor, an authentication request from the computing device. The method includes generating, based on values provided in the authentication request, a challenge-response message for the computing device. The method includes receiving, from the computing device, a responsive challenge-response message. The method includes verifying that the responsive challenge-response message includes an expected value and corresponds to an expected format. The method includes, in response to verifying the responsive challenge-response message, sending a sensor secret value to the computing device.
H04W 12/037 - Protecting confidentiality, e.g. by encryption of the control plane, e.g. signalling traffic
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
H04L 9/06 - Arrangements for secret or secure communicationsNetwork security protocols the encryption apparatus using shift registers or memories for blockwise coding, e.g. D.E.S. systems
H04L 9/32 - Arrangements for secret or secure communicationsNetwork security protocols including means for verifying the identity or authority of a user of the system
52.
METHODS FOR INCORPORATING THERAPEUTIC AGENTS INTO ANALYTE SENSORS
The present disclosure provides methods for depositing a therapeutic agent onto analyte sensors (e.g., to reduce signal inaccuracies or in vivo sensor failure, e.g., due to foreign body response (FBR)). In certain embodiments, the present disclosure relates to a process for coating (e.g., dip coating) analyte sensors with therapeutic agent-containing polymer compositions to obtain analyte sensors that include a therapeutic agent. The present disclosure further relates to sharps coated with a therapeutic agent.
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
53.
ANALYTE MONITORING AND MANAGEMENT DEVICE AND METHOD TO ANALYZE THE FREQUENCY OF USER INTERACTION WITH THE DEVICE
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
G06Q 50/22 - Social work or social welfare, e.g. community support activities or counselling services
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 80/00 - ICT specially adapted for facilitating communication between medical practitioners or patients, e.g. for collaborative diagnosis, therapy or health monitoring
Blood glucose meters; medical apparatus and instruments for diabetes management use; medical apparatus and instruments for monitoring glucose; medical apparatus for drawing or sampling blood or other bodily fluids, namely, lancets; sensor-based glucose monitors for medical purposes; glucose meters for medical purposes; continuous glucose monitoring systems composed of medical apparatus for monitoring glucose; medical diagnostic apparatus for determination of analyte concentrations; medical apparatus for monitoring analyte concentrations in interstitial fluid; patient monitoring sensors for monitoring analyte concentrations; sensors for monitoring analyte concentrations for health purposes; patient monitoring sensors for determination of analyte concentrations in interstitial fluid; sensors for determination of analyte concentrations in interstitial fluid for health purposes.
55.
SYSTEMS, DEVICES, AND METHODS FOR ANALYTE MONITORING
Systems, devices and methods are provided for inserting at least a portion of an in vivo analyte sensor for sensing an analyte level in a bodily fluid of a subject. In particular, disclosed herein are various embodiments of sensor control devices, and components thereof, designed to reduce the size and the number of internal components of the sensor control device. Further, the embodiments of the sensor control device and related sensor features disclosed herein are designed to increase comfort and convenience for the subject.
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 glucose monitoring device includes a housing configured to be placed on a skin surface of a user. The glucose monitoring device includes sensor electronics arranged within the housing. The glucose monitoring device further includes a glucose sensor that includes a first portion configured to be placed under the skin surface of the user for measuring signals indicative of glucose in a bodily fluid and a second portion configured to be arranged above the skin surface and that is coupled to the sensor electronics. The glucose monitoring device further includes a strain gauge disposed on the first portion and configured to detect a strain applied to the first portion.
A glucose monitoring device includes a housing configured to be placed on a skin surface of a user. The glucose monitoring device includes sensor electronics arranged within the housing. The glucose monitoring device further includes a glucose sensor that includes a first portion configured to be placed under the skin surface of the user for measuring signals indicative of glucose in a bodily fluid and a second portion configured to be arranged above the skin surface and that is coupled to the sensor electronics. The glucose monitoring device further includes a strain gauge disposed on the first portion and configured to detect a strain applied to the first portion.
Embodiments of the present disclosure relate to analyte determining methods and devices (e.g., electrochemical analyte monitoring systems) that have a sensing surface that includes two or more sensing elements disposed laterally to each other, where the sensing surface is on a working electrode of in vivo and/or in vitro analyte sensors, e.g., continuous and/or automatic in vivo monitoring using analyte sensors and/or test strips. Also provided are systems and methods of using the, for example electrochemical, analyte sensors in analyte monitoring.
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
C12Q 1/00 - Measuring or testing processes involving enzymes, nucleic acids or microorganismsCompositions thereforProcesses of preparing such compositions
60.
ANALYSIS OF GLUCOSE MEDIAN, VARIABILITY, AND HYPOGLYCEMIA RISK FOR THERAPY GUIDANCE
A system and method to provide guidance for diabetes therapy includes determining glycemic risks based on an analysis of glucose data. The analysis includes visualization of a glucose median, the variability of glucose in a patient, and the risk of hypoglycemia. An Advanced Daily Patterns report includes a visualization of an ambulatory glucose profile and a glucose control measure. The glucose control measure provides a highly visible and understandable display of the glucose condition of a patient visually expressed in the categories of low glucose, median glucose, and glucose variability.
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 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 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
61.
SYSTEMS, DEVICES, AND METHODS FOR ANALYTE MONITORING
Systems, devices and methods are provided for inserting and reinserting at least a portion of one in vivo analyte sensor for sensing an analyte level in a bodily fluid of a subject. In some emboidments, a sensor control device is disclosed which includes a first analyte sensor and a second analyte sensor, wherein the first analyte sensor and second analyte sensor can be configured to be inserted at different depths and can be configured to sense different physiological parameters. In particular, disclosed herein are various embodiments of applicators, sensor control devices, and components thereof, designed to reduce trauma to tissue of a sensor insertion site and to increase the likelihood of accurately monitoring the user's analyte level.
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 5/1486 - 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
62.
METHODS, DEVICES AND SYSTEMS FOR ANALYTE MONITORING MANAGEMENT
Methods of analyte monitoring management are provided. The methods include indicating a plurality of analyte management procedures available for user-selection, where the plurality of analyte management procedures is for determining analyte management parameters. The methods include receiving an indication to initiate a first procedure of the plurality of analyte management procedures, where the first procedure is for determining a first analyte management parameter. The methods further include outputting user-instructions associated with the first procedure; receiving analyte measurement data for the first procedure; estimating the first analyte management parameter based on the analyte measurement data; calculating a degree of certainty for the estimation of the first analyte management parameter; and, initiating an action in response to an event associated with a status of the estimation of the first analyte management parameter or the degree of certainty. Analyte monitoring devices and systems implementing the methods are also 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
G16B 99/00 - Subject matter not provided for in other groups of this subclass
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 20/00 - ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
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 80/00 - ICT specially adapted for facilitating communication between medical practitioners or patients, e.g. for collaborative diagnosis, therapy or health monitoring
Improved digital interfaces, graphical user interfaces, and alarms for analyte monitoring systems are provided. For example, disclosed herein are various embodiments of methods, systems, and interfaces for Silent Mode for alarms, Temporary Mode for alarms, escalating alarms, and alarm snooze features for an analyte monitoring software application. Also, various embodiments of interface enhancements are described, including caregiver alarms, among other embodiments.
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
G06F 16/13 - File access structures, e.g. distributed indices
Analyte sensors responsive at low working electrode potentials may comprise an active area upon a surface of a working electrode, wherein the active area comprises a polymer, a redox mediator covalently bonded to the polymer, and at least one analyte-responsive enzyme covalently bonded to the polymer. A specific redox mediator responsive at low potential may have a structure of
Analyte sensors responsive at low working electrode potentials may comprise an active area upon a surface of a working electrode, wherein the active area comprises a polymer, a redox mediator covalently bonded to the polymer, and at least one analyte-responsive enzyme covalently bonded to the polymer. A specific redox mediator responsive at low potential may have a structure of
Analyte sensors responsive at low working electrode potentials may comprise an active area upon a surface of a working electrode, wherein the active area comprises a polymer, a redox mediator covalently bonded to the polymer, and at least one analyte-responsive enzyme covalently bonded to the polymer. A specific redox mediator responsive at low potential may have a structure of
wherein G is a linking group covalently bonding the redox mediator to the polymer. A mass transport limiting membrane permeable to the analyte may overcoat the active area. In some sensor configurations, the mass transport limiting membrane may comprise a membrane polymer crosslinked with a branched crosslinker comprising three or more crosslinkable groups, such as polyethylene glycol tetraglycidyl ether.
The present disclosure provides methods for depositing a therapeutic agent onto analyte sensors (e.g, to reduce signal inaccuracies or in vivo sensor failure, e.g, due to foreign body response (FBR)). In certain embodiments, the present disclosure relates to a process for coating (e.g., dip coating) analyte sensors with therapeutic agent-containing polymer compositions to obtain analyte sensors that include a therapeutic agent. The present disclosure further relates to sharps coated with a therapeutic agent.
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 system, apparatus, or device that includes an analyte sensor for monitoring analyte levels. The system, apparatus, or device can include a printed circuit board. The system, apparatus, or device can also include a connector connected to the printed circuit board and configured to establish an electrical connection between the proximal portion of the analyte sensor and the printed circuit board. The system, apparatus, or device can also include a battery connected to the printed circuit board and configured to power the printed circuit board. The system, apparatus, or device can also include a processor connected to the printed circuit board and configured to process data associated with the monitored one or more analyte levels. The analyte sensor can have a proximal portion and a distal portion, wherein the distal portion is configured to extend beneath a user's skin to monitor one or more analyte levels in a bodily fluid.
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
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
68.
SYSTEMS, DEVICES, AND METHODS FOR ANALYTE MONITORING
Systems, devices and methods are provided for inserting at least a portion of an in vivo analyte sensor for sensing an analyte level in a bodily fluid of a subject. In particular, disclosed herein are various embodiments of sensor control devices, and components thereof, designed to reduce the size and the number of internal components of the sensor control device. Further, the embodiments of the sensor control device and related sensor features disclosed herein are designed to increase comfort and convenience for the subject.
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
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
A system, apparatus, or device that includes an analyte sensor for monitoring analyte levels. The system, apparatus, or device can include a printed circuit board. The system, apparatus, or device can also include a connector connected to the printed circuit board and configured to establish an electrical connection between the proximal portion of the analyte sensor and the printed circuit board. The system, apparatus, or device can also include a battery connected to the printed circuit board and configured to power the printed circuit board. The system, apparatus, or device can also include a processor connected to the printed circuit board and configured to process data associated with the monitored one or more analyte levels. The analyte sensor can have a proximal portion and a distal portion, wherein the distal portion is configured to extend beneath a user's skin to monitor one or more analyte levels in a bodily fluid.
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
H01Q 1/27 - Adaptation for use in or on movable bodies
H01Q 7/00 - Loop antennas with a substantially uniform current distribution around the loop and having a directional radiation pattern in a plane perpendicular to the plane of the loop
Methods, devices, and systems may use a kinetic model to determine physiological parameters related to the kinetics of red blood cell glycation, elimination, and generation. Such physiological parameters can be used, for example, to determine a more reliable calculated HbA1c. In another example, a method may comprise: receiving a plurality of glucose levels over a time period; receiving a glycated hemoglobin (HbA1c) level corresponding to an end of the time period; determining at least one physiological parameter selected from the group consisting of: a red blood cell glycation rate constant (kgly), a red blood cell generation rate constant (kgen), a red blood cell elimination constant (kage), and an apparent glycation constant (K), based on (1) the plurality of glucose levels and (2) the HbA1c level; and adjusting a glucose level target based on the at least one physiological parameter.
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
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
G01N 33/557 - ImmunoassayBiospecific binding assayMaterials therefor using kinetic measurement, i.e. time rate of progress of an antigen-antibody interaction
G01N 33/72 - Chemical analysis of biological material, e.g. blood, urineTesting involving biospecific ligand binding methodsImmunological testing involving blood pigments, e.g. hemoglobin, bilirubin
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
The present disclosure provides methods of processing data provided by a transcutaneous or subcutaneous glucose sensor utilizing different algorithms to strike a balance between signal responsiveness accompanied by signal noise and the introduction of error associated with that noise. The methods utilize the strengths of a lag correction algorithm and a smoothing algorithm to optimize the quality and value of the resulting data (glucose concentrations and the rates of change in glucose concentrations) to a continuous glucose monitoring system. Also provided are systems and kits.
Acupuncture needles may be used for piercing tissue with less trauma than may occur when employing larger gauge needles. However, because acupuncture needles are fabricated and packaged differently than are larger gauge needles, acupuncture needles may be less compatible with certain manufacturing processes. Needle assemblies compatible with manufacturing processes may comprise a continuous support material having a plurality of apertures defined therein, and a first injection molded coupler that surrounds a proximal portion of an acupuncture needle and connects the acupuncture needle to a first location upon the continuous support material, such that the acupuncture needle is held in a pre-determined orientation with respect to a longitudinal axis of the first injection molded coupler. The acupuncture needles in adjacent apertures may also be spaced apart substantially uniformly.
A61H 39/08 - Devices for applying needles to such points, i.e. for acupuncture
A61B 5/00 - Measuring for diagnostic purposes Identification of persons
B29C 45/00 - Injection moulding, i.e. forcing the required volume of moulding material through a nozzle into a closed mouldApparatus therefor
B29C 45/14 - Injection moulding, i.e. forcing the required volume of moulding material through a nozzle into a closed mouldApparatus therefor incorporating preformed parts or layers, e.g. injection moulding around inserts or for coating articles
Methods, apparatuses, and systems are provided for determining whether to administer a medication dose as a single dose or whether to fractionate the single dose to be administered as at least two discrete doses. Embodiments include determining a first analyte level and a first rate of change of the analyte level; determining an initial medication dose based on one or more anticipated subsequent medication doses, the first analyte level relative to an analyte level threshold, and the first rate of change of the analyte level relative to a rate of change threshold; administering the initial medication dose; determining a second analyte level and a second rate of change of the analyte level based on subsequent analyte data; and determining a subsequent medication dose based on the second analyte level relative to the analyte level threshold and the second rate of change relative to the rate of change threshold.
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
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
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
76.
Display screen or portion thereof with graphical user interface
The present disclosure provides analyte sensors comprising a sensor tail substrate having a lower portion and configured for insertion into a tissue; a first working electrode disposed on the lower portion of the sensor tail substrate; a first sensing layer disposed upon a surface of the first working electrode; and a membrane disposed over at least the sensing layer; wherein the membrane comprises 20% to 50% by weight of a silver salt. The present disclosure also provides methods of using such analyte sensors for detecting one or more analytes present in a biological sample and methods of manufacturing the analyte sensors.
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
A medical system comprising: an analyte sensor for receiving an analyte signal corresponding to an analyte concentration of a user; a health monitor device comprising a display unit and in communication with the analyte sensor, the health monitor device comprising a processor and memory communicably coupled to the processor, the memory including instructions stored therein that, when executed by the processor, cause the processor to: receive the analyte signal from the analyte sensor; determine the analyte concentration based on the analyte signal; calculate a recommended medication dosage based on the analyte concentration; associate a current parameter type with the recommended medication dosage; associate the current parameter type to at least one corresponding stored historical parameter type associated with a historical medication dosage; and display, on the display unit, the recommended medication dosage and the historical medication dosage.
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
A61M 5/315 - PistonsPiston-rodsGuiding, blocking or restricting the movement of the rodAppliances on the rod for facilitating dosing
G01N 33/487 - Physical analysis of biological material of liquid biological material
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
G16Z 99/00 - Subject matter not provided for in other main groups of this subclass
79.
FOCUSED STERILIZATION AND STERILIZED SUB-ASSEMBLIES FOR ANALYTE MONITORING SYSTEMS
An assembly for delivering an analyte sensor comprising a sensor control device. The sensor control device comprises an electronics housing with a shell having a first aperture and a first interface, and a mount having a second aperture and second interface, wherein the housing has an interior space. The two interfaces define a first sterile barrier. The housing also comprises a first mating member, a circuit board, and an analyte sensor. The assembly also comprises an applicator to deliver the sensor, and comprising a housing and a cap removably coupled to the housing to seal the applicator's interior, a sharp hub, and a second mating member extending within the first or second aperture, which mates with the first mating member to define a second sterile barrier. The sensor control device also comprises a collimator, a third sterile barrier, and a fourth sterile barrier which define a sterilization zone.
Systems comprising: an analyte sensor for providing an analyte signal representative of an analyte level; a controller in data communication with the analyte sensor and programmed to provide a recommended medication dose based on the analyte level and a medication type, the controller comprising a user interface for inputting the medication type; and a model-based safety mechanism integrated with the controller for evaluating the recommended medication dose. Wherein the model-based safety mechanism overrides the recommended medication dose and provides a safety medication dose when the model-based safety mechanism detects a risk of insulin deprivation.
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
81.
MEDICAL DEVICE ANTENNA SYSTEMS HAVING EXTERNAL ANTENNA CONFIGURATIONS
A medical device includes an antenna external to a case, package, or encapsulant for the electronic systems of the medical device. In one embodiment, a diabetes infusion pump is enclosed within a metal case, the pump including a processor and a communication module for wireless communications. An antenna is disposed in the delivery tubing of the pump outside the case with an antenna feed interconnecting the external antenna with the internal communication module. In another aspect, a thin film antenna is formed on the outer surf ace of the case in which a physiological parameter sensor, such as a glucose sensor, is enclosed. Multiple antennas may be used for communications on different frequencies.
Multiple enzymes may be present in the active area(s) of an electrochemical sensor to facilitate analysis of one or more analytes. The multiple enzymes may function independently to detect several analytes or in concert to detect a single analyte. One sensor configuration includes a first active area and a second active area, where the first active area has an oxidation-reduction potential that is sufficiently separated from the oxidation-reduction potential of the second active area to allow independent signal production. Some sensor configurations may have an active area overcoated with a multi-component membrane containing two or more different membrane polymers. Sensor configurations having multiple enzymes capable of interacting in concert include those in which a first enzyme converts an analyte into a first product and a second enzyme converts the first product into a second product, thereby generating a signal at a working electrode that is proportional to the analyte concentration.
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
C12Q 1/00 - Measuring or testing processes involving enzymes, nucleic acids or microorganismsCompositions thereforProcesses of preparing such compositions
83.
INCORPORATION OF SILVER SALTS WITHIN A TRANSCUTANEOUS BIOSENSOR FOR INFECTION CONTROL
The present disclosure provides analyte sensors comprising a sensor tail substrate having a lower portion and configured for insertion into a tissue; a first working electrode disposed on the lower portion of the sensor tail substrate; a first sensing layer disposed upon a surface of the first working electrode; and a membrane disposed over at least the sensing layer; wherein the membrane comprises 20% to 50% by weight of a silver salt. The present disclosure also provides methods of using such analyte sensors for detecting one or more analytes present in a biological sample and methods of manufacturing the analyte sensors.
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 27/333 - Ion-selective electrodes or membranes
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
G01N 33/543 - ImmunoassayBiospecific binding assayMaterials therefor with an insoluble carrier for immobilising immunochemicals
84.
Display screen or portion thereof with graphical user interface
Embodiments of the present disclosure include a method for receiving sensor data indicative of a glucose level from a glucose sensor configured to be positioned in contact with a bodily fluid under a skin surface of a subject, receiving, from a temperature sensor, temperature data indicative of a temperature of the skin surface, determining a rate of change of the glucose level, wherein the rate of change indicates a presence of a hypoglycemic condition, determining that a variation of the temperature of the skin surface is within a predetermined range of temperature values, and determining, in response to the variation of the temperature data, that the rate of change of the glucose level corresponds to a sensor signal attenuation.
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 of therapy escalation for patients with diabetes includes receiving glucose data of a user from an in vivo glucose monitoring device, receiving first therapy information of a first therapy, wherein the first therapy includes basal insulin, calculating one or more glucose metrics based on the received glucose data, titrating a dose of the basal insulin based on the one or more glucose metrics, and determining overbasalization based on one or more of the glucose data and the first therapy information. Advantageously the system can regularly monitor glucose control of a user, detect overbasalization, provide frequent therapy intervention and adjustment, decrease a duration of intervention, and increase user adherence, outcomes, and satisfaction.
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
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
88.
BIOSENSORS WITH HYDROPHILIC POLYURETHANE MEMBRANES
The present disclosure provides an analyte sensor comprising a working electrode, a sensing layer disposed on at least a portion of the working electrode, and a hydrophilic polyurethane membrane overcoating at least the sensing layer, wherein the hydrophilic polyurethane is aliphatic, aromatic, or both aliphatic and aromatic. The hydrophilic polyurethane membrane limits the transport of mass to the sensing layer without the need to be crosslinked. With such membrane, the analyte sensor can provide consistent analyte measurements over a temperature range of about 22-42° C. The present disclosure is further related to a method of forming an analyte sensor comprising providing a working electrode, disposing a sensing layer on at least a portion of the working electrode, and coating at least the sensing layer with a hydrophilic polyurethane membrane, wherein the hydrophilic polyurethane is aliphatic, aromatic, or both aliphatic and aromatic.
The present invention relates to analyte sensors for use in detecting the concentration of potassium ions in a biological fluid and methods of using the sensors.
The present invention relates to analyte sensors for use in detecting the concentration of potassium ions in a biological fluid and methods of using the sensors.
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value
C12Q 1/00 - Measuring or testing processes involving enzymes, nucleic acids or microorganismsCompositions thereforProcesses of preparing such compositions
92.
SYSTEMS, DEVICES, AND METHODS FOR INTEGRATION OF AN ANALYTE DATA READER AND MEDICATION DELIVERY DEVICE
Systems, devices and methods are provided for the integration of an analyte data reader and a medication delivery device. The integrated device can include a medication delivery portion, wireless communications circuitry configured to receive data indicative of an analyte level, and electronics. The integrated device can also include one or more near-field communication (NFC) antennas. Example embodiments of adverse condition protection features of the integrated device are also 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
A61M 5/14 - Infusion devices, e.g. infusing by gravityBlood infusionAccessories therefor
H01M 10/0525 - Rocking-chair batteries, i.e. batteries with lithium insertion or intercalation in both electrodesLithium-ion batteries
H04W 4/80 - Services using short range communication, e.g. near-field communication [NFC], radio-frequency identification [RFID] or low energy communication
The present invention provides systems, devices and methods for in vivo monitoring of an analyte level. In particular, the present invention relates to improved sensors for use in in vivo monitoring of an analyte level.
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
C08F 226/06 - Copolymers of compounds having one or more unsaturated aliphatic radicals, each having only one carbon-to-carbon double bond, and at least one being terminated by a single or double bond to nitrogen or by a heterocyclic ring containing nitrogen by a heterocyclic ring containing nitrogen
94.
METHODS FOR SINGLE CELL ANALYSIS OF GLUCOSE INTERNALIZATION
The subject matter disclosed herein relates to methods for analyzing and determining the kinetics of glucose internalization in single red blood cells, e.g., obtained from a patient. The present disclosure further provides kits and systems for performing the methods disclosed herein.
G01N 33/49 - Physical analysis of biological material of liquid biological material blood
G01N 33/557 - ImmunoassayBiospecific binding assayMaterials therefor using kinetic measurement, i.e. time rate of progress of an antigen-antibody interaction
The present disclosure includes methods, devices and systems for establishing a connection between a medical device and a remote computing device, receiving an upgrade command at the medical device, storing a current version of persistent data and a current version of executable code in a first storage area of the medical device, transmitting at least the current version of the persistent data to the remote computing device, receiving a second format of the current version of the persistent data and an upgraded version of executable code at the medical device, storing the second format of the current version of the persistent data and the upgraded version of the executable code in a second storage area of the medical device, and executing the upgraded version of the executable code with the second format of the current version of the persistent data.
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
G06F 8/654 - Updates using techniques specially adapted for alterable solid state memories, e.g. for EEPROM or flash memories
G06F 8/71 - Version control Configuration management
G06F 11/10 - Adding special bits or symbols to the coded information, e.g. parity check, casting out nines or elevens
G06F 11/14 - Error detection or correction of the data by redundancy in operation, e.g. by using different operation sequences leading to the same result
Digital and graphical user interfaces for multi-analyte monitoring systems are provided. For example, disclosed herein are various embodiments of methods, systems, and interfaces for alarm interfaces, alarm settings interfaces, alarm unavailability interfaces and features, and sensor results interfaces. Various embodiments of interfaces relating to glucose and ketone sensing are disclosed herein.
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
97.
FOCUSED STERILIZATION AND STERILIZED SUB-ASSEMBLIES FOR ANALYTE MONITORING SYSTEMS
An assembly for delivering an analyte sensor comprising a sensor control device. The sensor control device comprises an electronics housing with a shell having a first aperture and a first interface, and a mount having a second aperture and second interface, wherein the housing has an interior space. The two interfaces define a first sterile barrier. The housing also comprises a first mating member, a circuit board, and an analyte sensor. The assembly also comprises an applicator to deliver the sensor, and comprising a housing and a cap removably coupled to the housing to seal the applicator's interior, a sharp hub, and a second mating member extending within the first or second aperture, which mates with the first mating member to define a second sterile barrier. The sensor control device also comprises a collimator, a third sterile barrier, and a fourth sterile barrier which define a sterilization zone.
An analyte monitor includes a sensor, a sensor control unit, and a display unit. The sensor has, for example, a substrate, a recessed channel formed in the substrate, and conductive material disposed in the recessed channel to form a working electrode. The sensor control unit typically has a housing adapted for placement on skin and is adapted to receive a portion of an electrochemical sensor. The sensor control unit also includes two or more conductive contacts disposed on the housing and configured for coupling to two or more contact pads on the sensor. A transmitter is disposed in the housing and coupled to the plurality of conductive contacts for transmitting data obtained using the sensor. The display unit has a receiver for receiving data transmitted by the transmitter of the sensor control unit and a display coupled to the receiver for displaying an indication of a level of an analyte. The analyte monitor may also be part of a drug delivery system to alter the level of the analyte based on the data obtained using the sensor.
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
99.
ANALYTE MONITORING AND MANAGEMENT DEVICE AND METHOD TO ANALYZE THE FREQUENCY OF USER INTERACTION WITH THE DEVICE
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
G06Q 50/22 - Social work or social welfare, e.g. community support activities or counselling services
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 80/00 - ICT specially adapted for facilitating communication between medical practitioners or patients, e.g. for collaborative diagnosis, therapy or health monitoring
100.
SYSTEM, DEVICE AND METHOD OF DYNAMIC GLUCOSE PROFILE RESPONSE TO PHYSIOLOGICAL PARAMETERS
Method, device and system for providing consistent and reliable glucose response information to physiological changes and/or activities is provided to improve glycemic control and health management.
A61B 5/11 - Measuring movement of the entire body or parts thereof, e.g. head or hand tremor or mobility of a limb
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
G16B 40/10 - Signal processing, e.g. from mass spectrometry [MS] or from PCR
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
