Methods, systems, and devices for modeling a relationship between glucose sensitivity and a sensor electrical property are described herein. More particularly, the methods, systems, and devices describe partitioning an input signal feature space relating glucose sensitivity and a sensor electrical property into subspaces and training a model for each subspace. For example, the subspace models may form a mosaic of models, for which the output is more accurate than a single model.
Methods, systems, and devices for improving continuous glucose monitoring ("CGM") are described herein. More particularly, the methods, systems, and devices describe applying layered machine learning models to generate predicted sensor glucose values. The system may use the predicted sensor glucose values to display a sensor glucose value to a user. The layered models may generate more reliable sensor glucose predictions across many scenarios, leading to a reduction of sensor glucose signal blanking. The methods, systems, and devices described herein further comprise applying a plurality of micro model to estimate sensor glucose values under outlier conditions. The system may prioritize the models that are trained for certain outlier conditions when the system detects those outlier condition based on the sensor data.
An analyte sensor apparatus including a sensing portion including one or more electrodes including a working electrode and one or more contacts for electrically connecting the sensor portion to control circuitry (e.g., a printed circuit board assembly, PCBA); and a circuit comprising the one or more contacts; wherein the circuit detects an electrical connection between the control circuitry without requiring exposure of the sensing portion to a fluid.
Systems and methods are described herein for utilizing a photoacoustic sensor for estimating analyte concentration levels. Also described here are training methods for training an analyte sensor to more accurately estimate an analyte concentration level on the basis of a received acoustic signal.
Medical devices and related systems and methods are provided. A method of providing a notification pertaining to a physiological condition using a translation model involves identifying an error metric associated with an input variable associated with the translation model, determining a reference output of the translation model by providing reference values for the input variable to the translation model, generating modulated values for the input variable based on the reference values using the error metric, determining a simulated output of the translation model by providing the modulated values for the input variable to the translation model, and updating the translation model to reduce a weighting associated with the input variable when a difference between the simulated output and the reference output is greater than a threshold.
G16H 40/60 - ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
G16H 50/20 - ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for computer-aided diagnosis, e.g. based on medical expert systems
Embodiments are provided for dynamic management of charge. A method involves obtaining an estimated readiness time for an energy storage element, obtaining a target state of charge for the energy storage element, calculating an estimated charging time based at least in part on a difference between the target state of charge and a current state of charge, using a first charging rate to charge the energy storage element to an intermediate state of charge responsive to determining a time difference between the estimated readiness time and a first time is greater than the estimated charging time, maintaining the energy storage element at the intermediate state of charge, and responsive to determining a time difference between the estimated readiness time and a second time is less than the estimated charging time, using a second charging rate to charge the energy storage element to the target state of charge.
Devices, systems, and techniques for controlling delivery of therapy for diabetes are described. In one example, a system includes a wearable device configured to generate user activity data associated with an arm of a user; and one or more processors configured to: identify at least one gesture indicative of utilization of an injection device for preparation of an insulin injection based on the user activity data; based on the at least one identified gesture, generate information indicative of at least one of an amount or type of insulin dosage in the insulin injection by the injection device; compare the generated information to a criteria of a proper insulin injection; and output information indicative of whether the criteria is satisfied based on the comparison.
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
H04W 4/02 - Services making use of location information
G16H 40/60 - ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
A61B 5/00 - Measuring for diagnostic purposes ; Identification of persons
A61B 5/11 - Measuring movement of the entire body or parts thereof, e.g. head or hand tremor or mobility of a limb
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
An example system for therapy delivery includes one or more processors configured to in response to a prediction indicating that the meal event is to occur, output instructions to an insulin delivery device to deliver a partial therapy dosage, to a device to notify the patient to use the insulin delivery device to take the partial therapy dosage, or to the insulin delivery device to prepare the partial therapy dosage prior to the meal event occurring, and in response to a determination indicating that the meal event is occurring (e.g., based on movement characteristics of a patient arm), output instructions to the insulin delivery device to deliver a remaining therapy dosage, to the device to notify the patient to use the insulin delivery device to take the remaining therapy dosage, or to the insulin delivery device to prepare the remaining therapy dosage.
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
H04W 4/02 - Services making use of location information
G16H 40/60 - ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
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
A61B 5/00 - Measuring for diagnostic purposes ; Identification of persons
A fluid infusion system such as a portable fluid infusion device includes a housing to accommodate a fluid reservoir. The housing has a largest dimension and a smallest dimension. The fluid infusion device includes a drive system to be serially coupled to the removable fluid reservoir such that a combined dimension of the drive system and the fluid reservoir is less than or equal to the largest dimension. The fluid infusion device includes a planar battery configured to supply power to the drive system. The planar battery has a plurality of faces with one or more faces having a largest area, and the planar battery is situated such that the one or more faces are parallel to the largest dimension and the smallest dimension.
A method, system and platform are provided that can utilize a serverless architecture with autonomous functions to standardize nutritional and health data from various sources into a structured file format suitable for analysis. The platform may include an authentication component, a data retrieving component, a pipeline component, a standardization component, and a storage component. The components may include sets of autonomous functions, streaming applications, notification messages, and other objects logically connected to one another. The components may be connected serially and data may flow through the components sequentially in a stream. Using the disclosed architecture, the platform can aggregate and process large volumes of data in an efficient and cost-effective manner, analyze the standardized structured data, and generate personalized dietary and health advice or recommendations to individual end users.
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 20/60 - 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
G16H 50/20 - ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for computer-aided diagnosis, e.g. based on medical expert systems
11.
METHODS FOR MAKING AND OPERATING PHYSIOLOGICAL CHARACTERISTIC SENSORS
Methods for making and operating physiological characteristic sensors are presented here. An exemplary method includes providing a quantified effect of an electrical performance parameter on a calculation of a concentration of an analyte in a fluid sample. The method includes providing a group of sensors and testing a test sensor from the group of sensors with a known concentration of the analyte in a test sample to determine the electrical performance parameter of the test sensor. Further, the method includes associating the electrical performance parameter of the test sensor with a selected sensor from the group of sensors. The method may associate the quantified effect with the selected sensor, measure an unknown concentration of the analyte with the selected sensor, and input the measured electrical performance parameter and the quantified effect into an algorithm to provide an estimated blood analyte level.
An automated medication dispensing system provides for triggering a medication administration message when an inferred event is detected for which a medication administration message is to be sent. The event might be the start, the beginning, or an anticipation of a start, of an eating event, detected by an event detection module from gestures of a user from a set of sensor readings. The message can be a signal to medication dispensing apparatus, and/or a reminder message to the user, an ancillary message to a caregiver, health professional, or others. The medication administration message might comprise a signal to an input of an insulin management system or an input of a meal-aware artificial pancreas. The events might also include a drinking event, a smoking event, a personal hygiene event, and/or a medication related event.
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
13.
FLUID INFUSION SYSTEM THAT AUTOMATICALLY DETERMINES AND DELIVERS A CORRECTION BOLUS
A method of controlling an insulin infusion device involves controlling the device to operate in an automatic basal insulin delivery mode, obtaining a blood glucose measurement for the user, and initiating a correction bolus procedure when: the measurement exceeds a correction bolus threshold value; and a maximum basal insulin infusion rate is reached during the automatic basal insulin delivery mode. The correction bolus procedure calculates an initial correction bolus amount, and scales the initial amount to obtain a final correction bolus amount, such that a predicted future blood glucose level resulting from simulated delivery of the final correction bolus amount exceeds a low blood glucose threshold level. The final amount is delivered to the user during operation in the automatic basal insulin delivery mode.
An insulin infusion device and related operating methods are disclosed. An operating method maintains a configurable, patient-specific, target glucose setpoint for a user of the insulin infusion device, collects historical data associated with operation of the insulin infusion device, and calculates, from the historical data, a target glucose setpoint profile for the user of the insulin infusion device. A current target glucose setpoint value is automatically adjusted over time during a closed-loop operating mode of the insulin infusion device, in accordance with the calculated target glucose setpoint profile. In certain embodiments, the historical data is analyzed to determine a clinically preferred target glucose setpoint value for the user, which is stored for use during the closed-loop operating mode.
G16H 10/20 - ICT specially adapted for the handling or processing of patient-related medical or healthcare data for electronic clinical trials or questionnaires
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 20/17 - 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 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
G16H 40/63 - ICT specially adapted for the management or administration of healthcare resources or facilities; ICT 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 mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for computer-aided diagnosis, e.g. based on medical expert systems
G16H 50/50 - ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for simulation or modelling of medical disorders
A61B 5/00 - Measuring for diagnostic purposes ; Identification of persons
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration, pH-value
A61M 5/145 - Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. by means of pistons
A61M 5/168 - Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters
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
15.
INFUSION DEVICES AND RELATED MEAL BOLUS ADJUSTMENT METHODS
Medical devices and related systems and operating methods are provided. A method of operating an infusion device capable of delivering fluid influencing a physiological condition to a patient involves obtaining an event indication, such as a meal indication, determining an initial bolus amount based on the event indication, and determining predicted values for the physiological condition of the patient during a time window into the future based at least in part on the initial bolus amount. When the predicted values violate a threshold during the time window, the control system identifies an adjusted bolus amount that results in the predicted values for the physiological condition satisfying the threshold during the time window from within a search space defined by the initial bolus amount and operates an actuation arrangement of the infusion device to deliver the adjusted bolus amount of the fluid to the patient.
Infusion devices and related medical devices, patient data management systems, and methods are provided for monitoring a physiological condition of a patient. A method of managing a physiological condition of a patient using infusion of a fluid to influence the physiological condition of the patient involves obtaining a cost function representative of a desired performance for a bolus of the fluid to be delivered, obtaining a value for the physiological condition of the patient at a time corresponding to the bolus, determining a prediction for the physiological condition of the patient after the time corresponding to the bolus based at least in part on the value for the physiological condition using a prediction model, identifying a recommended amount of fluid to be associated with the bolus input to the prediction model that minimizes a cost associated with the prediction using the cost function, and providing indication of the recommended amount of fluid for the bolus.
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 mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for computer-aided diagnosis, e.g. based on medical expert systems
G16H 50/50 - ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for simulation or modelling of medical disorders
17.
INFUSION SET WITH PIVOTING METAL CANNULA AND STRAIN RELIEF
An infusion set for use with a fluid infusion device having a fluid reservoir includes a cannula that provides a fluid flow path and a first housing. The first housing includes an articulation member coupled to the cannula. The articulation member is pivotable relative to the first housing to move the cannula relative to the first housing. The first housing is coupled to a fluid supply line to provide a fluid to the cannula, and the fluid supply line is to be coupled to the fluid reservoir to receive the fluid. The infusion set includes a second housing uncoupled from the first housing that surrounds the first housing and receives a portion of the fluid supply line.
Embodiments of the invention provide compositions useful in analyte sensors as well as methods for making and using such compositions and sensors. In typical embodiments of the invention, the sensor is a glucose sensor comprising an analyte modulating membrane formed from a polymeric reaction mixture formed to include limiting amounts of catalyst and/or polycarbonate compounds so as to provide such membranes with improved material properties such as enhanced thermal and hydrolytic stability.
C12Q 1/00 - Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
C08G 18/00 - Polymeric products of isocyanates or isothiocyanates
An adhesive patch for a medical device having a hub, such as an infusion device, is provided. The adhesive patch includes a first backing layer to be coupled to the medical device. The first backing layer is composed of a first material. The adhesive patch includes a first adhesive layer coupled to the first backing layer and a second backing layer coupled to the first adhesive layer. The second backing layer is composed of a second material, and the second material is different than the first material. The adhesive patch includes a biocompatible second adhesive layer coupled to the second backing layer, and the second adhesive layer is to be coupled to an anatomy.
A medical device system and related method of automatically adjusting parameters of an insulin delivery controller of an insulin infusion device are disclosed. The methodology obtains data associated with operation of the insulin infusion device for a number of days in the past, including sensor glucose data associated with glucose levels of the user, and meal data associated with identified meals. The obtained data is processed to generate a suitable pharmacokinetic/pharmacodynamic (PK/PD) model of the user, wherein the PK/PD model fits at least some of the sensor glucose data obtained for the user. The PK/PD model can be used to calculate at least one adjusted parameter of the insulin delivery controller, based on additional data associated with further operation of the insulin infusion device. The insulin delivery controller can be instructed or controlled to adjust its settings in accordance with the model-calculated parameters.
G16H 40/63 - ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for local operation
G16H 20/17 - 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
A method includes providing access to assets through communication channels, to a community of users associated with a medical condition, where access is provided by a system including a communication control that selectively enables user devices. Goals are established to modify a health-related outcome of the community of users over time and effect a particular treatment for the medical condition. The goals can include a time-in-range metric that defines an amount of time that a user of the community of users maintains the health-related outcome within a range bounded by a lower limit and an upper limit. The goals can include a total days of sensor data metric that defines an amount of time that the user wore a glucose sensor. Access to engagement rewards can be enabled based on the interactions and/or achievement of the goals to improve one or more health outcomes associated with the medical condition.
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 40/63 - ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for local operation
A61B 5/00 - Measuring for diagnostic purposes ; Identification of persons
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration, pH-value
22.
SYSTEMS AND METHODS FOR FOOD ANALYSIS, PERSONALIZED RECOMMENDATIONS, AND HEALTH MANAGEMENT
The present disclosure provides methods and systems for providing personalized food and health management recommendations. The method may comprise mapping foods by abstracting information from data relating to foods to develop a food ontology. The method may comprise collecting and aggregating a plurality of data sets related to food, health, or nutritional information of a user. The plurality of data sets may be provided from a plurality of sources in a two or more data formats. The method may comprise converting the plurality of data sets into a standardized format that may be individualized for the user. The method may comprise applying a predictive model to the food ontology and the plurality of data sets of the user in the standardized format to determine effects of food consumption of the user's body.
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
23.
METHODS FOR CONTROLLING PHYSICAL VAPOR DEPOSITION METAL FILM ADHESION TO SUBSTRATES AND SURFACES
A method of depositing of a film on a substrate with controlled adhesion. The method comprises depositing the film including metal, wherein the metal is deposited on the substrate using physical vapor deposition at a pressure that achieves a pre-determined adhesion of the film to the substrate. The pre-determined adhesion allows processing of the film into a device while the film is adhered to the substrate but also allows removal of the device from the substrate.
Embodiments of the invention provide multilayer analyte sensors having material layers (e.g. high-density amine layers) and/or configurations of material layers that function to enhance sensor function, as well as methods for making and using such sensors. Typical embodiments of the invention include glucose sensors used in the management of diabetes.
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration, pH-value
A61B 5/1486 - Measuring characteristics of blood in vivo, e.g. gas concentration, pH-value using enzyme electrodes, e.g. with immobilised oxidase
C12Q 1/00 - Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
A single flex double-sided electrode useful in a continuous glucose monitoring sensor. In one example, a counter electrode is placed on the back-side of the flex and a work electrode is placed on the top-side of the sensor flex. The electrode is fabricated on physical vapor deposited metal deposited on a base substrate. Adhesion of the electrode to the base substrate is carefully controlled so that the electrode can be processed on the substrate and subsequently removed from the substrate after processing.
Embodiments of the invention provide optimized polymeric surfaces adapted for use with implantable medical devices as well as methods for making and using such polymeric surfaces. These polymer surfaces have a constellation of features that function to inhibit or avoid an inflammatory immune response generated by implantable medical devices. Typical embodiments of the invention include an implantable glucose sensor used in the management of diabetes having a polymer surface with the disclosed constellation of features.
A medical device includes a hub and an adhesive patch coupled to the hub. The adhesive patch is to couple the hub to an anatomy. The adhesive patch defines an edge that extends along a perimeter of the adhesive patch. The medical device includes an anisotropic shim coupled to the adhesive patch along the perimeter of the adhesive patch proximate the edge to resist an uncoupling of the adhesive patch from the anatomy. The shim has an inner periphery spaced apart from an outer periphery and the shim is locally rigid between the inner periphery and the outer periphery.
A pseudo-orthogonally redundant glucose sensor device may include one or more electrochemical peroxide-based glucose sensor(s) and one or more electrochemical oxygen-based sensor(s). The electrochemical peroxide-based glucose sensor(s) may operate as traditional peroxide-based sensor(s), which may include a chemistry stack with glucose oxidase as a catalytic agent. The electrochemical oxygen-based sensor(s) may be used to measure oxygen, as well as to measure glucose by computing differences in oxygen between two working electrodes. In embodiments of the invention, one of the oxygen-based sensors may be used directly as a diagnostic to determine whether each peroxide-based glucose sensor is functioning properly, as well as to determine which modality of sensing to use. Because of the internal oxygen-based reference, the glucose sensor device provides oxygen-resistant glucose sensing, as well as near-orthogonal redundancy.
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration, pH-value
A61B 5/1468 - Measuring characteristics of blood in vivo, e.g. gas concentration, pH-value using chemical or electrochemical methods, e.g. by polarographic means
A61B 5/1486 - Measuring characteristics of blood in vivo, e.g. gas concentration, pH-value using enzyme electrodes, e.g. with immobilised oxidase
29.
METHODS AND SYSTEMS FOR CONTINUOUS GLUCOSE MONITORING
A method for optional external calibration of a calibration-free glucose sensor uses values of measured working electrode current (Isig) and EIS data to calculate a final sensor glucose (SG) value. Counter electrode voltage (Vcntr) may also be used as an input. Raw Isig and Vcntr values may be preprocessed, and low-pass filtering, averaging, and/or feature generation may be applied. SG values may be generated using one or more models for predicting SG calculations. Complex redundancy may be employed to take operational advantage of disparate characteristics of two or more dissimilar, or non-identical, sensors, including, e.g., characteristics relating to hydration, stabilization, and durability of such sensors. Fusion algorithms, EIS, and advanced Application Specific Integrated Circuits (ASICs) may be used to implement use of such redundant glucose sensors, devices, and sensor systems in such a way as to bridge the gaps between fast start-up, sensor longevity, and accuracy of calibration-free algorithms.
A computer-implemented therapy management system is operated to collect patient data associated with medical device users. Treatment of the users is managed by healthcare professionals (HCPs), which include a customer HCP and a plurality of non-customer HCPs. The system receives a first set of attributes for a first individual patient or a first group of patients under care of the customer HCP, and a second set of attributes for a second individual patient or a second group of patients. The system identifies a first set of patient records associated with the customer HCP that satisfy the received first attributes, and a second set of patient records that satisfy the received second attributes, and compares patient outcomes from the first set of records against patient outcomes from the second set of records. A comparative therapy report is generated and communicated to a client device associated with the customer HCP.
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
The system disclosed here includes a computer-implemented patient therapy management and coaching system, a database system to collect and maintain patient data associated with a plurality of medical device users that includes a trainee patient assigned to a coach, and a user device communicatively coupled to the patient therapy management and coaching system and associated with the coach. The management and coaching system is operative to: receive a patient request for coaching; process the request to automatically identify goals to be achieved by the trainee patient; communicate the goals to the coach's user device; receive an accepted goal selected from the identified goals; create a patient coaching program for the accepted goal; generate insight messages based on patient data collected for the trainee patient, the generated insight messages related to the patient coaching program; and deliver the generated insight messages to the user device associated with the coach.
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
32.
WAFERSCALE PHYSIOLOGICAL CHARACTERISTIC SENSOR PACKAGE WITH INTEGRATED WIRELESS TRANSMITTER
An embodiment of a sensor device includes a base substrate, a circuit pattern formed overlying the interior surface of the substrate, a physiological characteristic sensor element on the exterior surface of the substrate, conductive plug elements located in vias formed through the substrate, each conductive plug element having one end coupled to a sensor electrode, and having another end coupled to the circuit pattern, a multilayer component stack carried on the substrate and connected to the circuit pattern, the stack including features and components to provide processing and wireless communication functionality for sensor data obtained in association with operation of the sensor device, and an enclosure structure coupled to the substrate to enclose the interior surface of the substrate, the circuit pattern, and the stack.
A continuous glucose monitoring system may utilize externally sourced information regarding the physiological state and ambient environment of its user for externally calibrating sensor glucose measurements. Externally sourced factory calibration information may be utilized, where the information is generated by comparing metrics obtained from the data used to generate the sensor's glucose sensing algorithm to similar data obtained from each batch of sensors to be used with the algorithm in the future. The output sensor glucose value of a glucose sensor may also be estimated by analytically optimizing input sensor signals to accurately correct for changes in sensitivity, run-in time, glucose current dips, and other variable sensor wear effects. Correction actors, fusion algorithms, EIS, and advanced ASICs may be used to implement the foregoing, thereby achieving the goal of improved accuracy and reliability without the need for blood-glucose calibration, and providing a calibration-free, or near calibration-free, sensor.
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration, pH-value
A61B 5/00 - Measuring for diagnostic purposes ; Identification of persons
A61B 5/1468 - Measuring characteristics of blood in vivo, e.g. gas concentration, pH-value using chemical or electrochemical methods, e.g. by polarographic means
A61B 5/1486 - Measuring characteristics of blood in vivo, e.g. gas concentration, pH-value using enzyme electrodes, e.g. with immobilised oxidase
A61B 5/1495 - Calibrating or testing in vivo probes
34.
METHODS, SYSTEMS, AND DEVICES FOR CALIBRATION AND OPTIMIZATION OF GLUCOSE SENSORS AND SENSOR OUTPUT
216 ABSTRACT: A continuous glucose monitoring system may utilize externally sourced information regarding the physiological state and ambient environment of its user for externally calibrating sensor glucose measurements. Externally sourced factory calibration information may be utilized, where the information is generated by comparing metrics obtained from the data used to generate the sensor's glucose sensing algorithm to similar data obtained from each batch of sensors to be used with the algorithm in the future. The output sensor glucose value of a glucose sensor may also be estimated by analytically optimizing input sensor signals to accurately correct for changes in sensitivity, run-in time, glucose current dips, and other variable sensor wear effects. Correction actors, fusion algorithms, EIS, and advanced ASICs may be used to implement the foregoing, thereby achieving the goal of improved accuracy and reliability without the need for blood-glucose calibration, and providing a calibration- free, or near calibration-free, sensor. Date Recue/Date Received 2020-11-05
A61B 5/1495 - Calibrating or testing in vivo probes
G16H 40/40 - ICT specially adapted for the management or administration of healthcare resources or facilities; ICT 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 5/00 - Measuring for diagnostic purposes ; Identification of persons
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration, pH-value
A61B 5/1468 - Measuring characteristics of blood in vivo, e.g. gas concentration, pH-value using chemical or electrochemical methods, e.g. by polarographic means
A61B 5/1486 - Measuring characteristics of blood in vivo, e.g. gas concentration, pH-value using enzyme electrodes, e.g. with immobilised oxidase
35.
METHODS, SYSTEMS, AND DEVICES FOR CALIBRATION AND OPTIMIZATION OF GLUCOSE SENSORS AND SENSOR OUTPUT
A continuous glucose monitoring system may utilize externally sourced information regarding the physiological state and ambient environment of its user for externally calibrating sensor glucose measurements. Externally sourced factory calibration information may be utilized, where the information is generated by comparing metrics obtained from the data used to generate the sensor's glucose sensing algorithm to similar data obtained from each batch of sensors to be used with the algorithm in the future. The output sensor glucose value of a glucose sensor may also be estimated by analytically optimizing input sensor signals to accurately correct for changes in sensitivity, run-in time, glucose current dips, and other variable sensor wear effects. Correction actors, fusion algorithms, EIS, and advanced ASICs may be used to implement the foregoing, thereby achieving the goal of improved accuracy and reliability without the need for blood-glucose calibration, and providing a calibration- free, or near calibration-free, sensor.
A61B 5/1495 - Calibrating or testing in vivo probes
A61B 5/00 - Measuring for diagnostic purposes ; Identification of persons
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration, pH-value
A61B 5/1468 - Measuring characteristics of blood in vivo, e.g. gas concentration, pH-value using chemical or electrochemical methods, e.g. by polarographic means
A61B 5/1486 - Measuring characteristics of blood in vivo, e.g. gas concentration, pH-value using enzyme electrodes, e.g. with immobilised oxidase
36.
PEDESTAL FOR SENSOR ASSEMBLY PACKAGING AND SENSOR INTRODUCER REMOVAL
A pedestal for a physiological characteristic sensor assembly and a physiological characteristic sensor assembly is provided The pedestal includes a first side opposite a second side The pedestal includes a sidewall that interconnects the first side and the second side The pedestal also includes a first end opposite a second end The pedestal includes at least one post that extends from the first side adjacent to the first end to couple the pedestal to a physiological characteristic sensor of the physiological characteristic sensor assembly The pedestal also includes a recess defined in the sidewall at the second end The recess has a first portion in communication with a second portion. The first portion has a first length that is less than a second length of the second portion along a perimeter of the sidewall, and the second portion is positionable to apply a force to the physiological characteristic sensor
A61B 5/1486 - Measuring characteristics of blood in vivo, e.g. gas concentration, pH-value using enzyme electrodes, e.g. with immobilised oxidase
A61B 5/00 - Measuring for diagnostic purposes ; Identification of persons
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration, pH-value
A61B 5/1473 - Measuring characteristics of blood in vivo, e.g. gas concentration, pH-value using chemical or electrochemical methods, e.g. by polarographic means invasive, e.g. introduced into the body by a catheter
37.
AMBULATORY INFUSION PUMPS AND ASSEMBLIES FOR USE WITH SAME
Ambulatory infusion pumps, cannula insertion mechanisms, and medicament sealing assemblies, including cannula seal assemblies, plus related components, as well as component combinations and related methods.
A method of initializing a sensor with a voltage sequence including a ramped voltage combined with a biphasic voltage pulse. The initialization scheme results in faster in-vitro sensor run-in and stabilization times. In various examples, the in-vitro sensor stabilization time is reduced from 200 minutes to 40-55 minutes (a reduction by a factor of least 5 as compared to a non-initialized sensor). In addition, staircase voltage initialization is implemented adaptively so that the voltage step size and sweep rates are changed depending on the state of the sensor (characterized by ISIG magnitude). As a result, individual sensors can be initialized in a customized manner rather than by using a general hardwired and harsh initialization scheme.
Analyte sensors and methods for fabricating analyte sensors are provided. In an exemplary embodiment, a planar flexible analyte sensor includes a flexible base layer and a first electrode formed from a layer of sputtered platinum on the base layer. Also, the analyte sensor includes an insulating dielectric layer over the base layer, wherein the insulating dielectric layer leaves a portion of the first electrode exposed. Further, the analyte sensor includes an electrochemical sensing stack over the exposed portion of the first electrode, including a glucose oxidase layer over the layer of sputtered platinum and a glucose limiting membrane over the glucose oxidase layer.
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration, pH-value
A61B 5/1473 - Measuring characteristics of blood in vivo, e.g. gas concentration, 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, pH-value using enzyme electrodes, e.g. with immobilised oxidase
C12Q 1/00 - Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
A flexible, fluid flow tubing is configured to be kink resistant, and a medical device is configured with such kink resistant tubing. The tubing has a length L, an inside radius r and an outside radius R, wherein L/R >= 34.8, and wherein R/r >= 1.5. A distal portion of the tubing is received in a channel of a hollow needle. The hollow needle is slideable axially relative to the tubing, to selectively slide off of the distal portion of the tubing. An insertion set system includes a base on which the tubing is secured, and an inserter having the needle and moveably received by the base. The base includes a fluid passage transverse to the axial dimension of the distal end portion of the tubing.
The invention is directed to a competitive glucose binding affinity assay comprising a glucose receptor (typically mannan binding lectin) labeled with an assay fluorophore and a modified glucose analog (typically dextran) labeled with a reference fluorophore. In certain embodiments, the glucose analog is dextran and is coupled to both a reference fluorophore and a quencher dye (e.g. hexamethoxy crystalviolet-1). Optionally the reference fluorophore is blue shifted relative to the assay fluorophore.
G01N 33/542 - Immunoassay; Biospecific binding assay; Materials therefor with immune complex formed in liquid phase with steric inhibition or signal modification, e.g. fluorescent quenching
The invention is directed to a competitive glucose binding affinity assay comprising a glucose receptor (typically mannan binding lectin) labeled with an assay fluorophore and a modified glucose analog (typically dextran) labeled with a reference fluorophore. In certain embodiments, the glucose analog is dextran and is coupled to both a reference fluorophore and a quencher dye (e.g. hexamethoxy crystalviolet-1). Optionally the reference fluorophore is blue shifted relative to the assay fluorophore.
G01N 33/542 - Immunoassay; Biospecific binding assay; Materials therefor with immune complex formed in liquid phase with steric inhibition or signal modification, e.g. fluorescent quenching
Infusion devices and related medical devices, patient data management systems, and methods are provided for monitoring a physiological condition of a patient. One exemplary method of monitoring a physiological condition of a patient involves obtaining current measurement data for the physiological condition of the patient provided by a sensing arrangement, obtaining a user input indicative of one or more future events associated with the patient, and in response to the user input, determining a prediction of the physiological condition of the patient in the future based at least in part on the current measurement data and the one or more future events using one or more prediction models associated with the patient, and displaying a graphical representation of the prediction on a display device.
The invention disclosed herein includes electrode compositions formed from processes that sputter metal in a manner that produces pillar architectures. Embodiments of the invention can be used in analyte sensors having such electrode architectures as well as methods for making and using these sensor electrodes. A number of working embodiments of the invention are shown to be useful in amperometric glucose sensors worn by diabetic individuals. However, the metal pillar structures have wide ranging applicability and should increase surface area and decrease charge density for catalyst layers or electrodes used with sensing, power generation, recording, and stimulation, in vitro and/or in the body, or outside the body.
A61B 5/1486 - Measuring characteristics of blood in vivo, e.g. gas concentration, pH-value using enzyme electrodes, e.g. with immobilised oxidase
C12Q 1/00 - Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
45.
COLOROMETRIC SENSOR FOR THE NON-INVASIVE SCREENING OF GLUCOSE IN SWEAT IN PRE AND TYPE 2 DIABETES
Described here are patches and methods for measuring glucose in sweat (and tears and the like). In general, the patches comprise an adhesive layer adapted to bond to skin of an individual, a substrate layer disposed over the adhesive layer and comprising a glucose sensing complex including a chromogen that changes color in the presence of certain concentrations of glucose, and a cover. In typical embodiments, the substrate layer has elements formed to direct and accumulate sweat that migrates from the skin of the individual to the glucose sensing complex. Methods of using the invention can comprise cleaning the skin surface, collecting sweat in a patch comprising this microfluidic constellation of elements, and observing concentrations of glucose collected in the sweat, for example either visually, or by using a smartphone or other computer processing device.
An ambulatory infusing device (10) including a housing (12), a reservoir (20) defining an interior volume (22), a wall (16) associated with the housing and having an inner surface (194) that faces into the reservoir interior volume, and a filter assembly (126). The filter assembly may include a filter assembly housing (154) with a housing filter portion having a filter supporting volume, a filter (156) located within the filter supporting volume, and a bubble guard (162), including a bubble guard wall (182) and at least one bubble guard aperture (184) that extends through the bubble guard wall, associated with the filter assembly housing such that the bubble guard wall is located in spaced relation to the filter.
A61M 5/36 - Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm rests with means for eliminating or preventing injection or infusion of air into body
A61M 5/38 - Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm rests with means for eliminating or preventing injection or infusion of air into body using hydrophilic or hydrophobic filters
47.
AMBULATORY INFUSION DEVICES AND FILTER ASSEMBLIES FOR USE WITH SAME
An ambulatory infusing device (10) including a housing (12), a reservoir (20) defining an interior volume (22), a wall (16) associated with the housing and having an inner surface (182) that faces into the reservoir interior volume, and a filter assembly. The filter assembly may include a filter assembly housing with a housing filter portion having a free end associated with the inner surface of the wall and a filter supporting volume that extends to the free end of the housing filter portion, and a filter (156) located within the filter supporting volume that extends to at least the free end of the housing filter portion.
A61M 5/36 - Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm rests with means for eliminating or preventing injection or infusion of air into body
A61M 5/38 - Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm rests with means for eliminating or preventing injection or infusion of air into body using hydrophilic or hydrophobic filters
Embodiments relate to a cannula that is provided for delivering a substance, such as a medicine (e.g., insulin) to a patient, where the cannula has reduced likelihood of kinking or occlusions when implanted in a patient. The cannula may have a reduced number of stress concentrations along its length, an angled tip and/or a curve in its length. The cannula may include other designs to reduce kinking, such as internal ribbing and/or a slit along its wall.
A61M 5/32 - Syringes - Details - Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
A61M 25/06 - Body-piercing guide needles or the like
This invention pertains to systems and components useful for infusing medications such as insulin. Typically, the components are used to This invention pertains to systems and components useful for infusing medications such as insulin. The system components typically comprise a cannula adapted for subcutaneous insertion into a diabetic patient. The system further comprises a fluid conduit adapted to deliver the insulin solution from a medication reservoir to the site of infusion and a depot in operable contact with the fluid conduit. The depot comprises selected materials including a site-loss mitigating agent (such as heparin) which inhibits inflammation at the site of infusion, and encapsulation of the cannula at the site of infusion. The site-loss mitigating agent is not premixed with the insulin, and instead is adapted to contact the insulin solution in the depot as the insulin solution flows from the medication reservoir to the site of infusion.
This invention pertains to systems and components useful for infusing medications such as insulin. The system components typically comprise a cannula adapted for subcutaneous insertion into a diabetic patient. The system further comprises a fluid conduit adapted to deliver the insulin solution from a medication reservoir to the site of infusion and a depot in operable contact with the fluid conduit. The depot comprises selected materials including a site-loss mitigating agent (such as heparin) which inhibits inflammation at the site of infusion, and encapsulation of the cannula at the site of infusion. The site-loss mitigating agent is not premixed with the insulin, and instead is adapted to contact the insulin solution in the depot as the insulin solution flows from the medication reservoir to the site of infusion.
A61M 5/38 - Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm rests with means for eliminating or preventing injection or infusion of air into body using hydrophilic or hydrophobic filters
Infusion systems, infusion devices, and related operating methods are provided. An exemplary method of operating an infusion device capable of delivering fluid to a patient involves obtaining, by a control system associated with the infusion device, an input meal indication, obtaining historical data for the patient associated with the input meal indication, determining an estimated carbohydrate amount corresponding to the input meal indication based at least in part on the historical data, determining a bolus dosage of the insulin based at least in part on the estimated carbohydrate amount, and operating an actuation arrangement of the infusion device to deliver the bolus dosage of the insulin to the patient.
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
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 5/168 - Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters
52.
INSERTION SITE MONITORING METHODS AND RELATED MEDICAL DEVICES AND SYSTEMS
Infusion systems, infusion devices, and related operating methods are provided. An exemplary method of operating an infusion device involves obtaining one or more measurement values of a physiological condition in the body of a user during an initial monitoring period and determining a fasting reference value for a metric based on the one or more measurement values. After the initial monitoring period, the method continues by obtaining an updated measurement value during a fasting period, determining a current value for the metric based at least in part on the updated measurement value, and generating a notification in response to a deviation between the current value and the fasting reference value exceeding a threshold indicative of insertion site loss or other loss of effectiveness.
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 40/63 - ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for local operation
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
A61B 5/00 - Measuring for diagnostic purposes ; Identification of persons
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration, pH-value
Disclosed is a medical device component for delivering medication fluid to a patient. The medical device component includes a fluid infusion device to regulate delivery of medication fluid, a body-mountable base unit, and a top cover assembly that is removably couplable to the base unit and to the fluid infusion device. The base unit includes a cannula to deliver medication fluid under the control of the fluid infusion device, and a physiological analyte sensor to measure a physiological characteristic. The base unit also includes an electronics assembly electrically connected to sensor leads to obtain measurements in the analog domain, to convert measurements into digital sensor data, and to communicate conditioned digital sensor data to the fluid infusion device. The top cover assembly is configured to provide both fluid and electrical connections for the base unit, by way of an infusion tube having sensor conductors integrated therein or otherwise associated therewith.
A method for providing blood glucose data is provided. In response to a suspension of a continuous basal insulin delivery, by an insulin delivery pump, the method identifies a condition indicating continuing hypoglycemia that continues when basal insulin delivery is suspended; and performs an action, by the insulin delivery pump, based on identifying the condition.
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 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration, pH-value
55.
POLYCARBONATE UREA/URETHANE POLYMERS FOR USE WITH ANALYTE SENSORS
Embodiments of the invention provide compositions useful in analyte sensors as well as methods for making and using such compositions and sensors. In typical embodiments of the invention, the sensor is a glucose sensor having an analyte modulating membrane. The analyte modulating layer includes a biocompatible composition including a polyurea-urethane copolymer formed from a reaction mixture. The polyurea-urethane copolymer exhibits an improved thermal stability.
C12Q 1/00 - Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
C12Q 1/54 - Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving glucose or galactose
56.
IN-SITU CHEMISTRY STACK FOR CONTINUOUS GLUCOSE SENSORS
Embodiments of the invention provide an in-situ polymerization technique for creating a glucose sensor chemistry stack. An analyte sensor comprises a crosslinked polymer matrix in contact with an electrode. The crosslinked polymer matrix is formed by exposing ultraviolet (UV) light to a polymer matrix mixture comprising a plurality of hydroxyethyl methacrylate (HEMA) monomers, one or more di-acrylate crosslinkers, one or more UV photoinitiators, and an oxidoreductase. The oxidoreductase is covalently linked to the crosslinked polymer matrix. In typical embodiments, the oxidoreductase is a glucose oxidase-acrylate bioconjugate. In one or more embodiments, the analyte sensor apparatus further comprises a glucose limiting membrane positioned over the crosslinked polymer matrix. The glucose limiting membrane is formed by exposing ultraviolet (UV) light to a glucose limiting membrane mixture comprising a plurality of hydroxyethyl methacrylate (HEMA) monomers, one or more di-acrylate crosslinkers, one or more UV photoinitiators, ethylene glycol, and water.
C12Q 1/00 - Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
A61B 5/1486 - Measuring characteristics of blood in vivo, e.g. gas concentration, pH-value using enzyme electrodes, e.g. with immobilised oxidase
57.
SET CONNECTOR SYSTEMS FOR VENTING A FLUID RESERVOIR
A set connector system for venting a gas from a fluid reservoir of a fluid infusion device is provided. The set connector system includes a connector system having a first body section coupled to a second body section. The first body section defines a bore in communication with a chamber and a counterbore of the second body section to define a fluid flow path from the fluid reservoir. The chamber of the second body section is in fluid communication with a vent subsystem defined through the second body section. The vent subsystem terminates in an outlet, and the vent subsystem directs gas in the fluid flow path through the second body section to the outlet.
A medical sensor device comprises: a sensor assembly having an underside surface for attachment against the skin of a patient, a sensor portion to detect a characteristic of the patient, and sensor assembly contacts which in operation carry signals representing the detected characteristic; a transmitter assembly removably engageable with the sensor assembly and having circuitry to take the signals from the sensor assembly contacts and to transmit readings of the detected characteristic to external equipment; characterized in that the medical sensor has mechanical interface components on the sensor assembly and the transmitter assembly which allow the transmitter assembly to be brought into abutment with the sensor assembly at a first angular position via relative axial movement between them, and then allows a relative rotation of the assemblies with respect to one another towards a second angular position and presents axial separation of the assemblies in the second angular position.
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration, pH-value
A61B 5/1468 - Measuring characteristics of blood in vivo, e.g. gas concentration, pH-value using chemical or electrochemical methods, e.g. by polarographic means
A61B 5/1486 - Measuring characteristics of blood in vivo, e.g. gas concentration, pH-value using enzyme electrodes, e.g. with immobilised oxidase
A medical sensing device (100) for sensing an analyte comprises: a case (110) having a lower major wall adapted to be mounted against the skin of the patient, and an upper opposing major wall; a sensor (12, 12A, 1012A, 12B, 1012B) extending from the case and having a distal end (15, 123A, 123B) sensitive to the analyte to produce an electrical signal, and a proximal end within the case having electrical contacts (18, 121A, 121B); a printed circuit board assembly (320, 1320) within the case supported by one of the major walls to receive the electrical signal via the electrical contacts (18, 121A, 121B); and an elastomeric pad (350) disposed in the case and biased by the other major wall to urge the said proximal end of the sensor into contact with the printed circuit board assembly (320, 1320) and maintain an electrical connection between the electrical contacts (18, 121A, 121B) and the printed circuit board assembly (320, 1320).
Apparatus for placing a medical device on the surface of the skin and inserting a filament extending from the device into the skin comprising a frame having a mouth for positioning against the skin during device placement and an internal cavity for retaining the device before placement. The device further comprises a surface for holding against the skin, the filament extending therefrom; a retractable needle carrying the filament; a striker holding the device, axially movable from a retracted position to a second position wherein the surface of the device is presented at the mouth of the frame; a driver to urge the striker towards the second position; a striker lock holding the striker in the retracted position; and a plunger axially movable towards the mouth, from a rest position to a firing position, the apparatus configured to release the striker lock, allowing the striker to move to the second position.
A medical sensor device comprises: a sensor assembly having an underside surface for attachment against the skin of a patient, a sensor portion to detect a characteristic of the patient, and sensor assembly contacts which in operation carry signals representing the detected characteristic; a transmitter assembly removably engageable with the sensor assembly and having circuitry to take the signals from the sensor assembly contacts and to transmit readings of the detected characteristic to external equipment; characterized in that the medical sensor has mechanical interface components on the sensor assembly and the transmitter assembly which allow the transmitter assembly to be brought into abutment with the sensor assembly at a first angular position via relative axial movement between them, and then allows a relative rotation of the assemblies with respect to one another towards a second angular position and presents axial separation of the assemblies in the second angular position.
Ambulatory infusion pumps, medicament reservoirs, and medicament sealing assemblies, including a variety of trocar seal assemblies and fill plug seal assemblies, plus related components, as well as component combinations and related methods.
Ambulatory infusion pumps, durable assemblies, and disposable assemblies, including energy sources, reservoirs, baseplates, and related components therefor, as well as component combinations and related methods.
A method for determining the validity of glucose sensor data is disclosed. The method includes performing an electrochemical impedance spectroscopy (EIS) procedure to obtain real impedance values for an electrode, analyzing said real impedance values to determine whether said values are stable, comparing a most-recently obtained real impedance value of said real impedance values to a first threshold value if said real impedance values are stable, and determining whether said sensor data is valid based on said comparison. The sensor data is determined to be valid if the most-recently obtained real impedance value is less than the first threshold value. Where the most- recently obtained real impedance value is greater than the first threshold value, the microcontroller detennines whether the real impedance values have exceeded a second threshold over a period of time.
A single, optimal, fused sensor glucose value may be calculated based on respective sensor glucose values of a plurality of redundant working electrodes (WEs) of a glucose sensor. Respective electrochemical impedance spectroscopy (EIS) procedures may be performed for each of the WEs to obtain values of membrane resistance (Rmem) for each WE. A noise value and a calibration factor (CF) value may be calculated for each WE, and respective fusion weights may be calculated for Rmem, noise, and CF for each WE. An overall fusion weight may then be calculated based on the WE' s Rmem fusion weight, noise fusion weight, and CF fusion weight, such that a single, optimal, fused sensor glucose value may be calculated based on the respective overall fusion weight and sensor glucose value of each of the plurality of redundant working electrodes.
A method for retrospective calibration of a glucose sensor uses stored values of measured working electrode current (Isig) to calculate a final sensor glucose (SG) value retrospectively. The Isig values may be preprocessed, discrete wavelet decomposition applied. At least one machine learning model, such as, e.g., Genetic Programing (GP) and Regression Decision Tree (DT), may be used to calculate SG values based on the Isig values and the discrete wavelet decomposition. Other inputs may include, e.g., counter electrode voltage (Vcntr) and Electrochemical Impedance Spectroscopy (EIS) data. A plurality of machine learning models may be used to generate respective SG values, which are then fused to generate a fused SG. Fused SG values may be filtered to smooth the data, and blanked if necessary.
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration, pH-value
A61B 5/1473 - Measuring characteristics of blood in vivo, e.g. gas concentration, pH-value using chemical or electrochemical methods, e.g. by polarographic means invasive, e.g. introduced into the body by a catheter
A61B 5/1495 - Calibrating or testing in vivo probes
An unscented Kalman filter is used to enable sensor calibration independently of the actual design of the subject sensors. By utilizing an unscented Kalman filter, an underlying calibration methodology is developed that is sensor-unspecific, such that a single calibration methodology and related systems may be used to calibrate various sensors, without the need to re-calculate a calibration factor for each specific sensor, and without the need to design a separate filtering mechanism to compensate for noise. In this way, various calibration inputs can be allowed to change over time without the need to change the codebase on which the calibration methodology otherwise operates. In multi-electrode systems, the methodology may incorporate a fusion algorithm to provide a single, fused sensor glucose value. The fusion algorithm may incorporate, and/or work in conjunction with, Electrochemical Impedance Spectroscopy (EIS) procedures.
A61B 5/1495 - Calibrating or testing in vivo probes
A61B 5/0538 - Measuring electrical impedance or conductance of a portion of the body invasively, e.g. using a catheter
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration, pH-value
A61B 5/1473 - Measuring characteristics of blood in vivo, e.g. gas concentration, pH-value using chemical or electrochemical methods, e.g. by polarographic means invasive, e.g. introduced into the body by a catheter
A fluid reservoir system is provided. The fluid reservoir system includes a fluid reservoir that defines a chamber to receive a fluid, and the fluid reservoir includes an outlet. The fluid reservoir system includes a source of pressure to draw the fluid into the outlet and a wicking membrane is coupled to the fluid reservoir that covers the outlet.
A61M 5/38 - Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm rests with means for eliminating or preventing injection or infusion of air into body using hydrophilic or hydrophobic filters
An improved sensor set is provided for sensing of a body characteristic, such as glucose. The sensor set includes a mounting base for the sensor and a connector to connect to the mounting base. The connector may contain sensor electronics for wired or wireless communication to an external monitor or display. The mounting base includes a connector fitting adapted to fit into a tubular recess in the connector, wherein the connector fitting includes a key. In some embodiments, the proximal end of the sensor folds around the key such that there are contact pads on both sides of the key. The mounting base and connector include additional features, such as pegs and prongs that allow for unique fitting of compatible mounting bases and connectors, while locking out non-compatible components.
An improved sensor set is provided for sensing of a body characteristic, such as glucose. The sensor set includes a mounting base for the sensor and a connector to connect to the mounting base. The connector may contain sensor electronics for wired or wireless communication to an external monitor or display. The mounting base includes a connector fitting adapted to fit into a tubular recess in the connector, wherein the connector fitting includes a key. In some embodiments, the proximal end of the sensor folds around the key such that there are contact pads on both sides of the key. The mounting base and connector include additional features, such as pegs and prongs that allow for unique fitting of compatible mounting bases and connectors, while locking out non-compatible components.
A protocol translation device for use with a first apparatus having a battery compartment and communicating over a first wireless protocol, and for use with a second apparatus communicating over a second wireless protocol. The protocol translation device can include a battery casing sized to fit within the battery compartment, the battery casing defining an interior volume; a translator having a first antenna operable to communicate with the first apparatus, a second antenna operable to communicate with the second apparatus, and a translator circuit operably connected between the first antenna and the second antenna; and a battery operably connected to power the translator. The translator circuit is operable to translate between the first wireless protocol and the second wireless protocol. The translator and the battery are disposed within the interior volume.
Infusion systems, infusion devices, and related operating methods are provided. An exemplary method of operating an infusion device (100,500) to deliver fluid to a body of a user involves obtaining measurement values for a physiological condition influenced by the fluid, autonomously operating the infusion device to deliver the fluid based at least in part on the measurement values, and detecting a nonactionable condition based on the measurement values. In response to detecting the nonactionable condition, delivery of the fluid is limited while maintaining autonomous operation of the infusion device. In one exemplary embodiment, the nonactionable condition is a rescue condition indicative of the user having consumed fast-acting carbohydrates, and thus insulin delivery may be automatically limited in response to detecting the rescue carbohydrate consumption.
Medical devices and related patient management systems and event detection methods are provided. An exemplary method of detecting events pertaining to operation of a medical device, such as an infusion device, involves obtaining measurements indicative of a condition in a body of a patient, determining statistics for an analysis interval based on the measurements, and determining an event probability associated with the analysis interval based on historical event data associated with the patient. An event detection model associated with the patient is obtained and applied to the statistics and the event probability to identify occurrence of the event using the event detection model, and in response, an indication of the event associated with the analysis interval is provided, for example, by tagging or marking data in a database, displaying graphical indicia of the event, or the like.
G16H 40/63 - ICT specially adapted for the management or administration of healthcare resources or facilities; ICT 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 mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for computer-aided diagnosis, e.g. based on medical expert systems
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration, pH-value
74.
METHODS FOR PROVIDING SENSOR SITE ROTATION FEEDBACK AND RELATED INFUSION DEVICES AND SYSTEMS
Infusion systems, infusion devices, and related operating methods are provided. An exemplary method of operating an infusion device to deliver fluid to a body of a user involves identifying a current site location on the body of the user associated with a sensing arrangement providing sensed measurements of a physiological condition in the body of the user at the current site location, determining one or more performance metrics associated with the current site location corresponding to operation of the infusion device to deliver the fluid in response to the sensed measurements, and providing sensor site feedback in a manner that is influenced by the one or more performance metrics. In one or more embodiments, the sensor site feedback includes recommended sensor site locations for rotation or replacement of the sensing arrangement determined based on historical data associated with the user for different sensor site locations.
Infusion systems, infusion devices, and related operating methods are provided. An exemplary method of operating an infusion device to deliver a bolus amount of fluid influencing a physiological condition in a body of a user involves identifying, based on measurement values for the physiological condition, a residual value for the physiological condition resulting from the bolus amount of the fluid and determining an updated ratio for a subsequent bolus by adjusting an initial ratio influencing the bolus amount to compensate for the residual value. The updated ratio may be stored in a data storage element for use in determining a subsequent bolus amount in lieu of the initial ratio value.
Medical devices and related patient management systems and parameter modeling methods are provided. An exemplary method of operating a sensing device associated with a patient involves obtaining current operational context information associated with the sensing device, obtaining a parameter model associated with the patient, calculating a current parameter value based on the parameter model and the current operational context information, obtaining one or more signals from a sensing element configured to measure a condition in a body of the patient, and providing an output that is influenced by the calculated current parameter value and the one or more signals.
G16H 40/63 - ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for local operation
G16H 50/50 - ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for simulation or modelling of medical disorders
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration, pH-value
A61B 5/1495 - Calibrating or testing in vivo probes
84 ABSTRACT A fluid infusion device includes a pump mechanism having a rotor and a stator. The rotor includes a reference surface and a cam element rising from the reference surface. The stator includes a cam element with a stator cam surface. The cam elements cooperate to axially displace the rotor as it rotates. A drive motor is coupled to actuate the rotor to pump medication fluid from a fluid cartridge module to a body, via a subcutaneous conduit. A sensor contact element resides on the reference surface in an area unoccupied by the rotor cam element. A sensing element terminates at the stator cam surface, and cooperates with a detection circuit to detect when the stator cam surface contacts the sensor contact element. The circuit monitors a detection signal obtained from the sensing element to determine an operating condition of the pump mechanism. Date Recue/Date Received 2020-07-08
A fluid infusion device includes a pump mechanism having a rotor and a stator. The rotor includes a reference surface and a cam element rising from the reference surface. The stator includes a cam element with a stator cam surface. The cam elements cooperate to axially displace the rotor as it rotates. A drive motor is coupled to actuate the rotor to pump medication fluid from a fluid cartridge module to a body, via a subcutaneous conduit. A sensor contact element resides on the reference surface in an area unoccupied by the rotor cam element. A sensing element terminates at the stator cam surface, and cooperates with a detection circuit to detect when the stator cam surface contacts the sensor contact element. The circuit monitors a detection signal obtained from the sensing element to determine an operating condition of the pump mechanism.
Infusion systems, infusion devices, and related operating methods are provided. An exemplary method of operating an infusion device to deliver fluid to a body of a user involves autonomously operating the infusion device to deliver a variable rate of infusion of the fluid in a first operating mode, determining a residual amount of active fluid in the body of the user based at least in part on the variable rate of infusion delivered by the infusion device in the first operating mode, and in response to identifying a change in operating mode from the first operating mode, generating a user notification based at least in part on the residual amount of active fluid. The residual amount represents infused fluid that exceeds a nominal amount corresponding to a reference rate of infusion for maintaining a physiological condition in the body of the user at a desired level.
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 20/17 - 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 facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for remote operation
80.
ADVANCE DIAGNOSIS OF INFUSION DEVICE OPERATING MODE VIABILITY
Infusion systems, infusion devices, and related operating methods are provided. An exemplary method of operating an infusion device to deliver fluid to a user in accordance with an operating mode involves obtaining operational information pertaining to one or more prior instances of the operating mode, obtaining status information pertaining to the infusion device, and determining a diagnosis time based at least in part on the operational information. The diagnosis time is prior to a subsequent instance of the operating mode. At the diagnosis time, the method automatically determines the viability of the subsequent instance of the operating mode based at least in part on the status information and automatically generates a notification indicative of a recommended action for the user based at least in part on the viability.
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 20/17 - 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 40/40 - ICT specially adapted for the management or administration of healthcare resources or facilities; ICT 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 40/60 - ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration, pH-value
A61M 5/168 - Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters
81.
METHODS FOR OPERATING MODE TRANSITIONS AND RELATED INFUSION DEVICES AND SYSTEMS
Infusion systems, infusion devices, and related operating methods are provided. An exemplary method involves operating an infusion device to deliver fluid to a user in accordance with a first operating mode of a plurality of operating modes, obtaining operational information pertaining to the first operating mode, and obtaining clinical information pertaining to the user. A destination operating mode of the plurality of operating modes is determined based at least in part on the operational information and the clinical information, and the infusion device is operated to deliver the fluid in accordance with the destination operating mode in a manner that is influenced by at least a portion of the operational information pertaining to the first operating mode.
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 20/13 - 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 from dispensers
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 40/63 - ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for local operation
ABSTRACT Infusion systems, infusion devices, and related operating methods are provided. An exemplary method of operating an infusion device to deliver fluid to a user in accordance with an operating mode involves obtaining operational information pertaining to one or more prior instances of the operating mode, obtaining status information pertaining to the infusion device, and determining a diagnosis time based at least in part on the operational information. The diagnosis time is prior to a subsequent instance of the operating mode. At the diagnosis time, the method automatically determines the viability of the subsequent instance of the operating mode based at least in part on the status information and automatically generates a notification indicative of a recommended action for the user based at least in part on the viability. 46 Date Recue/Date Received 2020-10-22
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 20/17 - 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 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration, pH-value
A61M 5/168 - Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters
83.
METHODS FOR OPERATING MODE TRANSITIONS AND RELATED INFUSION DEVICES AND SYSTEMS
ABSTRACT Infusion systems, infusion devices, and related operating methods are provided. An exemplary method involves operating an infusion device to deliver fluid to a user in accordance with a first operating mode of a plurality of operating modes, obtaining operational information pertaining to the first operating mode, and obtaining clinical information pertaining to the user. A destination operating mode of the plurality of operating modes is determined based at least in part on the operational information and the clinical information, and the infusion device is operated to deliver the fluid in accordance with the destination operating mode in a manner that is influenced by at least a portion of the operational information pertaining to the first operating mode. 48 Date Recue/Date Received 2021-05-25
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 20/17 - 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
A fluid conduit assembly for delivery of a medication fluid, and an associated fluid delivery system, are disclosed here. The fluid conduit assembly includes a trapping chamber having an interior volume to receive the medication fluid. The fluid conduit assembly also includes an inlet in fluid communication with the interior volume, a first outlet arrangement for the trapping chamber, and a second outlet arrangement for the trapping chamber. The first outlet arrangement accommodates flow of liquid from the interior volume, while inhibiting flow of gas from the interior volume. The second outlet arrangement accommodates flow of gas from the interior volume, while inhibiting flow of liquid from the interior volume.
A61M 5/38 - Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm rests with means for eliminating or preventing injection or infusion of air into body using hydrophilic or hydrophobic filters
A fluid delivery system and a fluid conduit assembly suitable for use with the system are disclosed herein. The system includes a fluid infusion pump and a fluid conduit assembly coupled to the pump to deliver medication fluid to a user. The fluid conduit assembly includes a structure defining a flow path for the medication fluid, and a gas trapping filter coupled to the structure and positioned in the flow path. The gas trapping filter functions to filter particulates from the medication fluid and retain gas bubbles from the medication fluid.
A61M 5/38 - Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm rests with means for eliminating or preventing injection or infusion of air into body using hydrophilic or hydrophobic filters
A method and apparatus for a connection interface between a reservoir or syringe, infusion set tubing, and an infusion pump is provided. The reservoir, a base and a cap are connected to form an integrated unit that is capable of being inserted and secured in an infusion pump housing. The cap and the infusion pump are each provided with at least one sensor or at least one detectable feature, arranged to interact with at least one corresponding detectable feature or sensor on the other of the cap and infusion pump device, to detect one or more of the presence, position or other characteristic of the cap when the cap is aligned or coupled with the infusion pump housing. The detectable feature and sensor may be magnetic, RF, mechanical, optical or any combination.
ABSTRACT A method and apparatus for a connection interface between a reservoir or syringe, infusion set tubing, and an infusion pump is provided. The reservoir, a base and a cap are connected to form an integrated unit that is capable of being inserted and secured in an infusion pump housing. The cap and the infusion pump are each provided with at least one sensor or at least one detectable feature, arranged to interact with at least one corresponding detectable feature or sensor on the other of the cap and infusion pump device, to detect one or more of the presence, position or other characteristic of the cap when the cap is aligned or coupled with the infusion pump housing. The detectable feature and sensor may be magnetic, RF, mechanical, optical or any combination. 324 Date Recue/Date Received 2020-12-18
A method and apparatus for a connection interface between a reservoir or syringe, infusion set tubing, and an infusion pump is provided. The reservoir, a base and a cap are connected to form an integrated unit that is capable of being inserted and secured in an infusion pump housing. The cap and the infusion pump are each provided with at least one sensor or at least one detectable feature, arranged to interact with at least one corresponding detectable feature or sensor on the other of the cap and infusion pump device, to detect one or more of the presence, position or other characteristic of the cap when the cap is aligned or coupled with the infusion pump housing. The detectable feature and sensor may be magnetic, RF, mechanical, optical or any combination.
175 ABSTRACT Electrochemical Impedance Spectroscopy (EIS) is used in conjunction with continuous glucose monitors and continuous glucose monitoring (CGM) to enable in-vivo sensor calibration, gross (sensor) failure analysis, and intelligent sensor diagnostics and fault detection. An equivalent circuit model is defined, and circuit elements are used to characterize sensor behavior. Date Recue/Date Received 2021-02-23
135 ABSTRACT: Methods and systems for sensor calibration and sensor glucose (SG) fusion are used advantageously to improve the accuracy and reliability of orthogonally redundant glucose sensor devices, which may include optical and electrochemical glucose sensors. Calibration for both sensors may be achieved via fixed-offset and/or dynamic regression methodologies, depending, e.g., on sensor stability and Isig-Ratio pair correlation. For SG fusion, respective integrity checks may be performed for SG values from the optical and electrochemical sensors, and the SG values calibrated if the integrity checks are passed. Integrity checks may include checking for sensitivity loss, noise, and drift. If the integrity checks are failed, in-line sensor mapping between the electrochemical and optical sensors may be performed prior to calibration. The electrochemical and optical SG values may be weighted (as a function of the respective sensor's overall reliability index (RI)) and the weighted SGs combined to obtain a single, fused SG value. Date Recue/Date Received 2021-03-05
A61B 5/1495 - Calibrating or testing in vivo probes
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration, pH-value
A61B 5/1455 - Measuring characteristics of blood in vivo, e.g. gas concentration, pH-value using optical sensors, e.g. spectral photometrical oximeters
A61B 5/1459 - Measuring characteristics of blood in vivo, e.g. gas concentration, pH-value using optical sensors, e.g. spectral photometrical oximeters invasive, e.g. introduced into the body by a catheter
A61B 5/1468 - Measuring characteristics of blood in vivo, e.g. gas concentration, pH-value using chemical or electrochemical methods, e.g. by polarographic means
A61B 5/1473 - Measuring characteristics of blood in vivo, e.g. gas concentration, pH-value using chemical or electrochemical methods, e.g. by polarographic means invasive, e.g. introduced into the body by a catheter
91.
METHODS AND SYSTEMS FOR IMPROVING THE RELIABILITY OF ORTHOGONALLY REDUNDANT SENSORS
Methods and systems for sensor calibration and sensor glucose (SG) fusion are used advantageously to improve the accuracy and reliability of orthogonally redundant glucose sensor devices, which may include optical and electrochemical glucose sensors. Calibration for both sensors may be achieved via fixed-offset and/or dynamic regression methodologies, depending, e.g., on sensor stability and Isig-Ratio pair correlation. For SG fusion, respective integrity checks may be performed for SG values from the optical and electrochemical sensors, and the SG values calibrated if the integrity checks are passed. Integrity checks may include checking for sensitivity loss, noise, and drift. If the integrity checks are failed, in-line sensor mapping between the electrochemical and optical sensors may be performed prior to calibration. The electrochemical and optical SG values may be weighted (as a function of the respective sensor's overall reliability index (RI)) and the weighted SGs combined to obtain a single, fused SG value.
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration, pH-value
A61B 5/1455 - Measuring characteristics of blood in vivo, e.g. gas concentration, pH-value using optical sensors, e.g. spectral photometrical oximeters
A61B 5/1459 - Measuring characteristics of blood in vivo, e.g. gas concentration, pH-value using optical sensors, e.g. spectral photometrical oximeters invasive, e.g. introduced into the body by a catheter
A61B 5/1468 - Measuring characteristics of blood in vivo, e.g. gas concentration, pH-value using chemical or electrochemical methods, e.g. by polarographic means
A61B 5/1473 - Measuring characteristics of blood in vivo, e.g. gas concentration, pH-value using chemical or electrochemical methods, e.g. by polarographic means invasive, e.g. introduced into the body by a catheter
A61B 5/1495 - Calibrating or testing in vivo probes
92.
USE OF ELECTROCHEMICAL IMPEDANCE SPECTROSCOPY (EIS) IN CONTINUOUS GLUCOSE MONITORING
Electrochemical Impedance Spectroscopy (EIS) is used in conjunction with continuous glucose monitors and continuous glucose monitoring (CGM) to enable in-vivo sensor calibration, gross (sensor) failure analysis, and intelligent sensor diagnostics and fault detection. An equivalent circuit model is defined, and circuit elements are used to characterize sensor behavior.
Methods and devices are provided for reducing a diabetic patient's foreign body immune response, including infusion site-loss and/or occlusion. Such foreign body responses are associated with the treatment of the diabetic patient where the treatment requires subcutaneous implantation of a foreign body, such as a cannula or catheter. In certain embodiments of the invention, a response-inhibiting agent is administered to a patient at the site of cannula/catheter insertion, thereby facilitating delivery of insulin to the diabetic patient and mitigating site-loss and/or occlusion over a period of time.
A device for detection or measurement of a carbohydrate analyte in fluid comprises: - an optical sensor comprising components of an assay for carbohydrate analyte, the readout of which is a detectable or measurable optical signal, and a light guide having a distal portion optically coupled to the assay components and a proximal portion; and - a reader for interrogating the optical sensor, the reader comprising an assay interrogating system including a lens; and - an interface portion forming part of at least one of the optical sensor and the reader, the interface portion being capable of removably constraining the proximal portion of the light guide and the lens of the assay interrogating system in an optically coupled arrangement. The device may be combined with an insulin-infusion system.
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration, pH-value
A61B 5/00 - Measuring for diagnostic purposes ; Identification of persons
A61B 5/1455 - Measuring characteristics of blood in vivo, e.g. gas concentration, pH-value using optical sensors, e.g. spectral photometrical oximeters
A61B 5/1459 - Measuring characteristics of blood in vivo, e.g. gas concentration, pH-value using optical sensors, e.g. spectral photometrical oximeters invasive, e.g. introduced into the body by a catheter
A therapeutic agent injection device including an injection device for delivering a therapeutic agent to a patient having a body, the body having a patient face and an port face opposite the patient face, the port face having an introducer port including an introducer channel and an injection port including an injection channel, the introducer channel being in fluid communication with the injection channel through a cross channel, the injection channel defining an injection axis; a delivery tube for subcutaneous delivery of the therapeutic agent to the patient, the delivery tube projecting from and being generally perpendicular to the patient face, the delivery tube defining an introducer axis and being in fluid communication with the injection port; and a patch, the patch being attached to the patient face and being operable to adhesively attach to the patient; wherein the injection axis is parallel to the introducer axis.
Apparatus are provided for medical devices and related operating systems and methods. An exemplary medical device includes a motor, one or more data storage elements to maintain control information, and a control module coupled to the motor and the one or more data storage elements. The control module is configured to obtain updated control information via a peer-to-peer communication session over a network, store the updated control information in the one or more data storage elements, and thereafter operate the motor based at least in part on the updated control information.
G16H 40/60 - ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
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 40/40 - ICT specially adapted for the management or administration of healthcare resources or facilities; ICT 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 40/63 - ICT specially adapted for the management or administration of healthcare resources or facilities; ICT 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 facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for remote operation
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
97.
MUTING GLUCOSE SENSOR OXYGEN RESPONSE AND REDUCING ELECTRODE EDGE GROWTH WITH PULSED CURRENT PLATING
The invention disclosed is an amperometric glucose sensor having electrodes formed from processes that electrodeposit platinum black by using a pulsed plating process. This can produce relatively smooth three dimensional metal architectures, ones that contribute to sensor reliability and stability. Embodiments of the invention provide analyte sensors having such uniform electrode architectures as well as methods for making (and using) these sensor electrodes. Such electrodes can be used in amperometric glucose sensors worn by diabetic individuals.
A single sensor electrode is provided. The single sensor electrode has a base layer and a plurality of electrically conductive members disposed on the base layer in an array. The array has at least electrically conductive members that form the single sensor electrode. The base layer has a plurality of indentations and the conductive members are individually positioned within the indentations. The electrically conductive members each have an electroactive surface shaped as a circular disc and adapted to sense fluctuations in electrical current. The array of electrically conductive members is coupled to a common electrical conduit. The array of electrically conductive members is arranged to be coupled to the common electrical conduit so as to be electrically linked as a group. The single sensor electrode may be included as part of an analyte sensor apparatus. A method for making the single sensor electrode is also provided.
A method is provided for initializing an analyte sensor, such as a glucose sensor. Where a sensor has been disconnected and reconnected, a disconnection time is determined and a sensor initialization protocol is selected based upon the disconnection time. The sensor initialization protocol may include applying a first series of voltage pulses to the sensor. A method for detecting hydration of a sensor is also provided.
Processor-implemented methods of controlling an insulin infusion device for a user are provided here. A first method obtains and analyzes calibration factors (and corresponding timestamp data) for a continuous glucose sensor, and regulates entry into a closed-loop operating mode of the infusion device based on the calibration factors and timestamp data. A second method obtains a most recent sensor glucose value and a target glucose setpoint value for the user at the outset of the closed-loop mode. The second method adjusts the closed-loop insulin infusion rate over time, in response to the sensor glucose value and the setpoint value. A third method calculates an upper insulin limit that applies to the insulin infusion rate during the closed-loop mode. The insulin limit is calculated based on a fasting blood glucose value of the user, a total daily insulin value of the user, and fasting insulin delivery data for the user.
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 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 40/63 - ICT specially adapted for the management or administration of healthcare resources or facilities; ICT 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 mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for computer-aided diagnosis, e.g. based on medical expert systems
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration, pH-value
A61B 5/1495 - Calibrating or testing in vivo probes
patents
