Termination of application of an electric pulse to a shape memory alloy (SMA) element that causes actuation of a medicament pump based on resistance values. The magnitude of the resistance values, the rate of change of the resistance values, the temperature of the SMA element, the time that has passed since initial the application of the electric pulse to the SMA element, or combinations thereof may be used to trigger the termination of the application of the electric pulse to the SMA element.
Disclosed herein is a system and method for calculating an expected peak blood glucose level of a user during a post-prandial period, based on a quantity of carbohydrates to be ingested. The user's expected peak blood glucose levels for slow, medium and fast acting carbohydrates are calculated. The results are presented to the user to allow the user to make an informed decision regarding the type of meal to be ingested.
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
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
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
A drug delivery device drive mechanism including a first ratchet wheel having a first ratchet gear coupled to a first spur gear, a second ratchet wheel having a second ratchet gear coupled to a second spur gear, wherein the first ratchet wheel and the second ratchet wheel are coplanar and gear teeth of the first spur gear mesh with gear teeth the second spur gear, and an actuation mechanism including a pusher interface coupled to an actuator, the pusher interface having at least one pusher tab operable to physically contact the first ratchet gear.
Disclosed are techniques, devices and systems that provide adjustments to parameter settings of an insulin delivery algorithm based on inputs from a number of generic sensor devices. A majority of the generic sensor devices provide sensor readings that are unused as inputs to a drug deliver algorithm. The generic sensor devices may be operable to detect characteristics, such as changes in a state of a user. A processor may evaluate a sensor reading provided by a particular sensor with respect to a sensor baseline reading for the particular sensor. Using the result of the evaluation, the processor may calculate an adjustment to a parameter setting or settings of a medication delivery algorithm. A dosage of medication may be modified based on the adjustment of the parameter setting or settings.
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 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
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 5/00 - Measuring for diagnostic purposes ; Identification of persons
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration, pH-value
A61M 5/172 - Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters electrical or electronic
5.
MECHANISM PROVIDING VARIABLE FILL CAPABILITY FOR A LIQUID RESERVOIR AND PUMP
Disclosed herein are various embodiments of clutching mechanisms applicable to a dual reservoir pumping mechanism for a drug delivery device, the clutching mechanisms serving to allow translation of one of the reservoirs during the filling process and thereafter connecting the reservoirs together such that one can be driven relative to the other one by means of a leadscrew or other driving mechanism.
Exemplary embodiments may apply a transform or filter to analyte level values of the users to make the analyte level values conform with a normal distribution that is symmetric relative to the mean. The transformed or filtered analyte level values may be used by the control system of a medicament delivery device in determining medicament delivery doses. In some embodiments, the medicament is insulin, and the analyte level is a glucose level of a user. In such instances, a logarithmic filter or transform may be applied to the glucose level readings of the user.
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 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
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration, pH-value
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
7.
SAFETY AND ACCURACY MEASURES FOR MEDICAMENT BOLUS DELIVERY
Safety and accuracy measures may be provided in a medicament delivery device. The medicament delivery device may be able to identify the inadvertent delivery of duplicate medicament boluses by a user. The exemplary embodiments may set limits for maximum allowable medicament bolus doses and maximum cumulative bolus doses over an interval. The exemplary embodiments may provide automatic meal detection and may use detection of meals in determining whether a user-requested medicament bolus dose should be adjusted or rejected. The exemplary embodiments may facilitate delivery of partial boluses and the delivery of remainders of the boluses contingent on acceptable glucose level trends of the user. The exemplary embodiments may resolve potential conflicts among multiple medicament delivery devices via a broker or by providing a single actor, such as a medicament delivery controller, that has sole control of dosing and delivery of medicament boluses.
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
Disclosed are techniques, devices and systems that provide a rotary solenoid micro actuator that has a rotary solenoid core with dual magnetic drive coils and magnetic field focusing elements. One or more examples may also include a spring return and other examples may include two sets of drive coils to push and pull on at each magnetic gap. The magnetic field focusing elements are operable to increase the magnetic field. The rotary solenoid micro actuator is configured to cause a liquid drug to be expelled from a drug delivery device.
H02K 33/12 - Motors with reciprocating, oscillating or vibrating magnet, armature or coil system with armatures moving in alternate directions by alternate energisation of two coil systems
9.
PUMP MECHANISM WITH DOUBLE RESERVOIR AND STATIONARY FLUID PORTS
Disclosed herein is a double reservoir configuration for a pumping mechanism for a drug delivery device wherein one reservoir is rigidly fixed to a housing of the device and the other reservoir moves linearly translates with respect to the fixed reservoir. To avoid having either the input fluid port or the output fluid port moves as the second reservoir linearly translates, one port is in fluid communication with the fixed reservoir and a second fluid port is in communication with the moving reservoir via a hollow tube supporting a static plunger disposed within the moving reservoir. This arrangement provides for the added benefit of allowing air trapped within either of the reservoirs to be almost completely removed as the pump mechanism is filled with the fluid.
Exemplary embodiments may determine anticipated basal insulin delivery action to a user from an insulin delivery device over a future time window. Indications of the anticipated basal insulin delivery action over the future time window may be output to the user. The exemplary embodiments may determine the anticipated basal insulin delivery action over the future time window based on a rate of change (ROC) of glucose level of the user by the insulin delivery device, a most recent ("current") glucose level for the user and insulin on board (IOB) for the user. The exemplary embodiments may also determine whether the user is likely to experience a undesired high glucose level (e.g., hyperglycemia) and/or an undesired low glucose level (e.g., hypoglycemia) during the future time window. The exemplary embodiments may output recommendations based on the projected glucose levels of the user over the future time window.
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 50/30 - ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for individual health risk assessment
G16H 50/70 - ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for mining of medical data, e.g. analysing previous cases of other patients
11.
WEARABLE DRUG DELIVERY DEVICE WITH INCORPORATED FILTRATION
A drug delivery device including a reservoir operable to contain a liquid drug, a fluid outlet including an outlet reservoir opening and an outlet fluid channel, wherein the outlet reservoir opening has a volume and is fluidly coupled to the outlet fluid channel, and an outlet filter plug operable to fill the volume of the outlet reservoir opening and collect particulate material as the liquid drug is expelled from the reservoir.
Disclosed are techniques, devices and computer products in which a processor is operable to access blood glucose measurement values and insulin data from a data memory. Based on the blood glucose measurement values the processor may be operable to identify high events that exceed an upper target blood glucose set point and low events in which blood glucose measurement values are below a lower target blood glucose set point. Rules may be applied to the high events and low events. Based on a result of the rules, high event patterns may be identified as well as a low event pattern. A respective pattern weight may be applied to each identified high event and each identified low and a graphical user interface may be populated with a number of high event patterns and for a number of low event patterns.
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
A61B 5/00 - Measuring for diagnostic purposes ; Identification of persons
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 50/30 - ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for individual health risk assessment
13.
CUSTOMIZATION OF A GLUCOSE PREDICTION MODEL FOR A USER IN AN AUTOMATED INSULIN DELIVERY (AID) DEVICE
The exemplary embodiments may employ a glucose prediction model (GPM) that is tailored to a user to account for insulin sensitivity or insulin insensitivity. The exemplary embodiments may predict future glucose levels based on past glucose levels for the user. Specifically, the GPM in exemplary embodiments may predict the future glucose level of the user as a weighted sum of most recent glucose level readings from the user. The exemplary embodiments may employ linear regression analysis to determine the values of the weights. These weights customize the GPM of the user based on the user's most recent glucose level history. Due to the customization, the GPM may more accurately predict future glucose levels of the user. As a result, the AID may exhibit better glucose level control for the user. The GPM of the exemplary embodiments may be updated on an ongoing basis.
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 50/50 - 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
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 50/30 - ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for individual health risk assessment
14.
SWITCHING AND CUSTOMIZATION OF GLUCOSE PREDICTION MODELS IN MEDICAMENT DELIVERY DEVICES
Exemplary embodiments may provide for the switching of glucose prediction models responsive to certain conditions. For example, glucose prediction models may be switched responsive to a detected crashing glucose level condition. Exemplary embodiments also may dynamically customize parameters, such as coefficient values, of the glucose prediction model to a user. The exemplary embodiments may customize the glucose prediction model based on the history of glucose levels of the user and the history of insulin deliveries to the user. The exemplary embodiments may determine a set of parameters that provides an improved fit of the parameters to the history of glucose levels and insulin deliveries of the user. The improved fit parameters may be used to adapt the parameter set to the most recent run.
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 50/30 - ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for individual health risk assessment
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 50/50 - 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
15.
METHODS AND SYSTEMS FOR DYNAMICALLY CUSTOMIZING INSULIN ON BOARD PROFILES AND PROVIDING RECOMMENDATIONS TO IMPROVE THE DURATION OF INSULIN ACTION
The exemplary embodiments may dynamically adjust an Insulin on Board (IOB) profile for a user of a medicament delivery system to customize the IOB profile to the user based on recent glucose level history and insulin deliveries rather than use the conventional static IOB profiles that are based on population averages. The exemplary embodiments may calculate a Duration of Insulin Action (DIA) for a user from the customized insulin decay curves. The exemplary embodiments may generate and send notifications to the user to help reduce the DIA of the user and/or to keep the DIA of the user from rising. The exemplary embodiments may aim to not overly constrain insulin delivery due to the contribution of insulin boluses to IOB.
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
G16H 20/17 - ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients delivered via infusion or injection
16.
INSULIN ADAPTATION AND SAFETY MONITORING FOR SICK DAY MANAGEMENT
Disclosed are an apparatus, system, processes, and techniques for adapting drug delivery and monitoring a user's safety when the user is experiencing a sick day. A processor may be operable to provide a graphical user interface that presents a sickness mode prompt for a user to indicate that the user or another person with diabetes is sick. The graphical user interface may present symptoms from which a user may select. Based on the selection of symptoms, glucose measurement values, and/or ketone measurement values, a response to the user's indication of sickness may be provided.
G16H 20/17 - ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients delivered via infusion or injection
G16H 20/30 - ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to physical therapies or activities, e.g. physiotherapy, acupressure or exercising
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 40/67 - 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
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 50/30 - ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for individual health risk assessment
17.
MEDICAMENT ADAPTATION AND SAFETY MONITORING IN A CLOSED-LOOP GLUCOSE MONITORING ENVIRONMENT
Disclosed are exemplary drug delivery systems that include controllers, drug delivery devices, and the like. The disclosed drug delivery system and controllers may include a processor, a user interface, a memory, and communication circuitry. An automated drug delivery algorithm is operable to receive a number of different inputs related to a user's glucose and/or ketone levels. The automated drug delivery algorithm(s) of the described drug delivery systems and controllers are operable to adjust to when a user partakes in fasting for a period of time that lasts a day or multiple days. The period of time may be a fasting event, such as a religious holiday or diet regimen. For example, the disclosed automated drug delivery algorithm(s) are operable to receive an indication of initiation of a fasting mode; and modify a drug delivery schedule based on the period of fasting or while in fasting mode.
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 20/30 - ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to physical therapies or activities, e.g. physiotherapy, acupressure or exercising
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 40/67 - 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
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 50/30 - ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for individual health risk assessment
18.
ADAPTIVE BASAL PORTION VALUE IN AN AUTOMATED MEDICAMENT DELIVERY DEVICE BASED ON HISTORIC MEDICAMENT DELIVERY FOR A USER
The exemplary embodiments may provide adaptivity in the basal portion value. The exemplary embodiments may also provide adaptivity of the total daily medicament (TDM) delivery amount. The adaptivity provided by the exemplary embodiments helps to customize medicament delivery to the needs of the user of a medicament delivery device. The exemplary embodiments may adapt the basal ratio for the user based on historical medicament delivery data for the user. In addition, the exemplary embodiments may update the basal ratio based upon more recent trends that diverge from the historical medicament delivery data. The degree of adaptivity provided by the exemplary embodiments may be bound to not exceed an upper threshold and/or a lower threshold. The degree of adaptivity may be modulated by controlling the rate of adaptivity too small increments each time the basal ratio is updated.
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
A61B 5/00 - Measuring for diagnostic purposes ; Identification of persons
A61M 1/00 - Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
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
Disclosed herein is a combination of an automated insulin delivery system and a continuous glucose monitor integrated into a single, wearable package. The system may use any combination of delivery methods and detection methods, wherein the delivery methods include a cannula, a microneedle array, and a transdermal patch, and wherein the detection methods include electrochemical methods, opto-fluorescent methods, and spectrographic methods.
Embodiments of the present disclosure relate to techniques, processes, devices or systems for pump devices. In one approach, a wearable drug delivery device may include a reservoir configured to store a fluid, the reservoir including a housing defining an interior chamber. The wearable drug delivery device may further include a drive device for driving the fluid from the reservoir, the drive device including a plunger head within the interior chamber of the housing, and a plunger shaft extending from the plunger head. The plunger shaft may include a first component adjacent a second component, wherein during movement of the plunger head in a first direction the first and second components engage one another to form a rigid portion of the plunger shaft, and wherein during movement of the plunger head in a second direction, opposite the first direction, the first and second components are separated from one another.
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 20/10 - 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 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
22.
POSITIVE DISPLACEMENT PUMPING MECHANISM WITH DOUBLE RESERVOIR
Disclosed herein is a double reservoir configuration for a spatially efficient pumping mechanism comprising an outer reservoir and an inner reservoir, wherein a linear translation of the inner reservoir causes the inner reservoir to move into the outer reservoir and act as a plunger for the outer reservoir to force fluid contained in the outer reservoir through a first fluid port. A static plunger disposed within the inner reservoir causes fluid disposed within the inner reservoir to be forced through a second fluid port. Also disclosed are various drive mechanisms for causing the linear translation of the first reservoir into the second reservoir.
Disclosed herein are systems and methods for providing safeguards, in an automatic drug delivery system, to prevent or compensate for insufficient delivery of bolus doses of a liquid drug. The safeguards include, for example, features built into the medication delivery algorithm to allow the medication delivery algorithm to ensure that proper bolus doses are delivered, either manually by the user or automatically by the drug delivery system. In addition, various methods are described for providing the medication delivery algorithm with a means for determining when a meal has been ingested and, in some embodiments, for providing an automatic bolus dose of the liquid drug in response to the determination.
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
24.
OPTIMIZING EMBEDDED FORMULATIONS FOR DRUG DELIVERY
Disclosed herein is a method for execution by a drug delivery device for determining an optimal dose of a liquid drug for current cycle of a medication delivery algorithm, the method utilizing a stepwise evaluation of a model and a cost function across a coarse search space consisting of coarse discrete quantities of the drug and a refined search space consisting of refined discrete quantities of the drug.
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 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
25.
CAPACITANCE SENSING FOR COMPONENT POSITIONING DETECTION
Disclosed herein are drug delivery devices and methods for component positioning of a pump, such as a linear shuttle pump. In some approaches, a system may include first and second terminals movable with respect to one another, and a sensor device operable to detect a change in capacitance between the first and second terminals as the first and second terminals move with respect to one another. The sensor device may include a two-stage charger connected with a controller and a voltage source, the two-stage charger having a first capacitor connected with a first switch and a second capacitor connected with a second switch, the controller being operable to close the first switch to connect the first capacitor with the voltage source to charge the first capacitor, and open the first switch and close the second switch to connect the second capacitor with the voltage source to charge the second capacitor.
G01D 5/241 - Mechanical means for transferring the output of a sensing member; Means for converting the output of a sensing member to another variable where the form or nature of the sensing member does not constrain the means for converting; Transducers not specially adapted for a specific variable using electric or magnetic means influencing the magnitude of a current or voltage by varying capacitance by relative movement of capacitor electrodes
A novel embodiment of a drive mechanism for use in a pump, for example, of the type that would be used in a wearable drug delivery system, comprises, a cylindrically-shaped slider element configured with a channel on a circumferential surface thereof defining one or more zig-zag-shaped tracks therethrough. One or more pegs are engaged within the tracks, such that a back and forth longitudinal motion of the slider element along a radial axis of the cylinder causes movement of the pegs along one of the tracks through the channel, thus providing a movement of the pegs around the circumference of the cylinder which imparts a rotational motion to a header element disposed co-axially with the slider. The header element is in turn connected to a gear train, for example, a planetary gear box, which is coupled to the pump via a linkage or other type of mechanism.
Disclosed are techniques and devices that are operable to receive one or a number of generalized parameters of an automated insulin delivery algorithm. An input of at least one generalized parameter corresponding to a user may be used to set one or more of the number of specific parameters of the automated insulin delivery algorithm based on the inputted at least one generalized parameter. Physiological condition data related to the user may be collected. The automated insulin delivery algorithm may determine a dosage of insulin to be delivered based on the collected physiological condition. Signals may be output to cause a liquid drug to be delivered to the user based on an output of the automated insulin delivery algorithm related to the determined dosage of insulin.
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 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 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
28.
CLUTCH DEVICE FOR COMPACT POSITIVE DISPLACEMENT PUMP OF A WEARABLE DRUG DELIVERY DEVICE
Embodiments of the present disclosure relate to techniques, processes, devices or systems for pump devices. In one approach, a wearable drug delivery device, may include a reservoir configured to store a fluid, the reservoir comprising a housing including an outer wall defining an interior chamber, and a drive mechanism for driving the fluid from the reservoir. The drive mechanism may include a plunger received in the interior chamber of the reservoir, a leadscrew extending from the plunger, and a clutch mechanism threadably engaged with the leadscrew, wherein the clutch mechanism is configured to allow the leadscrew to pass through the clutch mechanism when disengaged and is configured to grip the leadscrew when engaged such that the clutch mechanism rotates to advance the leadscrew and the plunger into the reservoir.
Disclosed herein are various embodiments of a pump mechanism comprising a rigid structure having an open end and a closed end, a plunger disposed in the open end of the rigid structure, and a flexible, fluid-proof sheet of material attached to an inner wall of the rigid structure and bonded to the head of the plunger such as to form a fluid barrier between the interior of the rigid structure and the plunger. Movement of the plunger toward the closed end of the rigid structure causes a rolling corner to be formed between the head of the plunger and the rigid structure and a fluid contained within the pump chamber to be forced out of the pump chamber via a fluid port defined in the closed end of the rigid structure.
The disclosed embodiments are directed to methods for determining, based on input from a manual insulin delivery device, for example, an insulin pen, a proper bolus dosing to be delivered by an AID system, to assess the sufficiency of the user-administered basal dose of long-acting insulin and to recommend any changes to the long-acting delivery following a daily analysis of the user's blood glucose readings.
Spring-based sensor devices are described. For example, a spring-based sensor system may include at least one spring associated with a mechanical element, the at least one spring operative to change from a first state to a second state based on a configuration of the mechanical element, sensing circuitry configured to determine an electrical property of the at least one spring, the electrical property to have a first value when the at least one spring is in the first state and a second value when the at least one spring is in the second state, and a logic device to determine a status of the mechanical element based on the electrical property. Other embodiments are described.
Embodiments of the present disclosure relate to techniques, processes, devices or systems for pump devices. In one approach, a wearable drug delivery device may include a reservoir configured to store a liquid drug, the reservoir including a housing including an outer wall defining an interior chamber, a sealing member, and a slit through the housing, wherein the sealing member is configured to seal the slit. The wearable drug delivery device may further include a delivery pump device including a drive mechanism coupled to the reservoir for driving the liquid drug out of the reservoir, the drive mechanism including a piston head disposed within the interior chamber of the housing, and a lead screw coupled to a drive nut, wherein the drive nut comprises a blade adjacent the piston head, and wherein the blade is positionable through the slit of the housing.
Wearable fluid delivery devices and pump systems having a pump status determination assembly to determine a status of at least one component of a fluid pump are described. For example, in one embodiment, a fluid pump system for a wearable fluid delivery device may include a control system, a first pump element associated with a first electrical element, a second pump element associated with a second electrical element, wherein the first pump element is configured to engage the second pump element to form an electrical circuit between the first, electrical element and the second electrical element, the control system configured to receive at least one signal from the electrical circuit. Other embodiments are described.
F04B 9/04 - Piston machines or pumps characterised by the driving or driven means to or from their working members the means being mechanical the means being cams, eccentrics or pin-and-slot mechanisms
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
A61M 5/145 - Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. by means of pistons
34.
IMPROVED DRIVE MECHANISMS FOR POSITIVE DISPLACEMENT PUMPS
A novel embodiment of a pump system, for example, of the type that would be used in a wearable drug delivery system, comprises, in a preferred embodiment, a reservoir, a plunger, disposed within the reservoir and driven by a scissor mechanism connected to a drive mechanism through a linkage, such that a force imparted by the drive mechanism in causes the scissor mechanism to expand thereby causing the plunger move within the reservoir to force a liquid drug contained within the reservoir through a fluid port to a patient.
Exemplary embodiments may modify the cost function parameters based on current and projected mean outcomes in blood glucose level control performance. The exemplary embodiments may modify the weight coefficient R for the insulin cost so that the value of R is not fixed and is not based solely on clinical determined values. Exemplary embodiments may also adjust the cost function to address persistent low-level blood glucose level excursions for users. The exemplary embodiments may reduce the penalty of the insulin cost by the sum of the converted insulin cost of the glucose excursions above target for a period divided by a number of cycles of average insulin action time. The AID system reduces the insulin cost by the lack of insulin in previous cycles.
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 5/14 - Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
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
36.
OPPORTUNISTIC RETRIEVAL OF ANALYTE VALUE TO IMPROVE AUTOMATIC DRUG CONTROL ACCURACY
Disclosed are processes and techniques implementable by devices and a drug delivery system to maintain optimal drug delivery for a user according to a user's diabetes treatment plan. The disclosed techniques enable a drug delivery device that received an analyte measurement value from an analyte sensor during a prior cycle time to determine a present analyte measurement value has not been received during a present cycle time. A processor of the drug delivery device may, in response to the determination, initiate an action to obtain the present analyte measure value from another device or an estimate of the present analyte measurement value. Based on an outcome of the initiated action, the processor may calculate a dosage of the drug using the present analyte measurement value or information related to the present analyte measurement value. The drug delivery device may also be operable to output the calculated dosage of the drug.
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
37.
ADAPTABLE ASYMMETRIC MEDICAMENT COST COMPONENT IN A CONTROL SYSTEM FOR MEDICAMENT DELIVERY
The exemplary embodiments provide medicament delivery devices that use cost functions in their control systems to determine medicament dosages. The cost function may have a medicament cost component and a performance cost component. The exemplary embodiments may use cost functions having medicament cost components that scale asymmetrically for different ranges of inputs (i.e., different candidate medicament dosages). The variance in scaling for different input ranges provides added flexibility to tailor the medicament cost component to the user and thus provide better management of medicament delivery to the user and better conformance to a performance target. The exemplary embodiments may use a cost function that has a medicament cost component (such as an insulin cost component) of zero for candidate dosages for a range of candidate dosages (e.g., below a reference dosage).
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 5/14 - Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
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
38.
A MEDICAMENT DELIVERY DEVICE WITH AN ADJUSTABLE AND PIECEWISE ANALYTE LEVEL COST COMPONENT TO ADDRESS PERSISTENT POSITIVE ANALYTE LEVEL EXCURSIONS
The exemplary embodiments may modify a glucose cost component of the cost function of the control loop of an insulin delivery device to compensate for persistent positive low level glucose excursions relative to a target glucose level. The exemplary embodiments may enable use of different glucose cost component functions for different glucose levels of the user. These glucose cost component functions may be employed in piecewise fashion with a different piece being applied for each respective range of glucose level values for the user. The final glucose cost function for calculating the glucose cost component may be a weighted combination of a piecewise glucose cost function and a weighted standard cost function (such as a quadratic function). The weights may reflect the magnitude and/or persistence of glucose excursions relative to a target glucose level.
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 5/14 - Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
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
39.
ADAPTATION OF AUTOMATIC INSULIN DELIVERY (AID) FOR USERS WITH BASAL TO BOLUS MISMATCH
Exemplary embodiments provide more customized basal insulin amounts for users to better regulate blood glucose (BG) concentration levels. The exemplary embodiments do not statically assume that the daily basal amount for each user is 50% of TDI. Instead, actual TDI data may be gathered for each user and may be used to adjust the TDI value for that user to an updated value. In addition, the ratio of basal to TDI may be adjusted for the user based on the actual ratio determined from data gathered over one or more days. As a result, better BG concentration level control may be realized.
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
40.
INTEGRATION OF SENSORS FOR DRUG DELIVERY COMPENSATION IN AUTOMATED MEDICATION DELIVERY (AMD) SYSTEMS
Disclosed are techniques, products, and an automatic medication delivery system that includes a drug delivery system configured to implement a diabetes treatment management plan. The drug delivery system of the automatic medication delivery system includes a drug delivery device having a processor, a memory storing programming code executable by the processor, a drug container configured to contain a liquid drug, a pump drive mechanism configured to expel the liquid drug from the drug delivery device, and an auxiliary device interface coupled to the processor and configured with a data connection. The drug delivery system also includes a sensor module configured to couple to the auxiliary device interface of the drug delivery device, the sensor module including one or more sensors. The one or more sensors may be configured to detect movement or a physical attribute of a person wearing the drug delivery device and sensor.
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
41.
DRUG DELIVERY DEVICE INCLUDING PUMP WITH FLOATING MICRONEEDLE ASSEMBLY
Embodiments of the present disclosure relate to techniques, processes, devices or systems including a floating microneedle assembly decoupled from the device and protected by a pump housing. In one approach, a wearable drug delivery device may include a pump housing including a base attachable to a user, and a microneedle assembly coupled to a cannula. The microneedle assembly may be operable to deliver a liquid drug to the user, wherein the microneedle assembly comprises a carrier positioned proximate an opening of the base, and wherein the carrier comprises a plurality of microneedles operable to extend through the opening of the base to penetrate a skin of the user.
The disclosed examples provide techniques and devices for determining a daily basal profile or an adjusted basal need for a drug based on a collection of data that is filtered and processed. A controller may be configured to evaluate a history of drug delivery in both basal and bolus dosages and generate a daily basal profile or an adjusted basal need that is a time dependent that may be used to schedule basal dosages of a drug that more closely addresses a user's drug needs over the course of a time period, such as a day, week or the like.
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 20/10 - 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 50/00 - ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics
43.
CONDUCTIVE ELEMENT IN ADHESIVE PATCH OF ON-BODY DRUG DELIVERY DEVICE FOR BODY CHANNEL COMMUNICATION
In an exemplary embodiment, a drug delivery device is configured for Body Channel Communication (BCC). The drug delivery device may include a conductive element embedded in an adhesive patch that secures the drug delivery device to the user. This conductive element acts as a coupler to the body of the user. Another conductive element may also be provided at a face of the housing. This conductive element acts as the other end of the coupler formed with the conductive coil in the adhesive patch. The conductive coil in the adhesive patch conforms well to the user's skin surface and thus facilitates a good quality coupling with the user.
Disclosed herein are systems and methods for the delivery of a co-formulation of insulin and a second drug, such as GLP-1, using an automated insulin delivery system. In a first embodiment, a dose of insulin is calculated by a medication delivery algorithm and a reduction factor is applied to account for the effect of second drug on the user's daily insulin requirement. In a second embodiment of the invention, a total amount of the second drug administered to the user during the past 24 hours is used to modify the correction factor and the insulin-to-carbohydrate ratio used by the medication delivery algorithm to cause a reduction in the insulin delivered to the user to account for the effect of the administration of the second drug portion of the co-formulation.
G16H 50/70 - ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for mining of medical data, e.g. analysing previous cases of other 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
Disclosed herein are systems and methods for the delivery of insulin and pramlintide using an automated insulin delivery system. In a first embodiment, a drug delivery system is configured to deliver independent doses of insulin and pramlintide. The system monitors the user's blood glucose level and determines when a meal is been ingested and, in response, delivers the dose of pramlintide which, in turn alters the required delivery of insulin. In the second embodiment, the drug delivery system is configured to deliver a co-formulation of insulin and pramlintide as basal doses. The total amount of pramlintide delivered in a most recent pre-determine period of time, for example, 24 hours, is used to alter the aggressiveness of the algorithm which determines the basal doses of the co-formulation.
G16H 50/70 - ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for mining of medical data, e.g. analysing previous cases of other 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
Disclosed are examples of devices, systems and techniques for delivering a liquid drug. An example delivery pump device may include a chamber body defining a pump chamber, an inlet valve to receive a liquid drug and a hard stop. A plunger configured with a plunger channel. A sliding fluidic member including a needle coupling, a flow orifice, a face seal and an anchor portion that may be movable within the pump chamber. A pump mechanism may be coupled to the anchor portion and operable to pull the anchor portion and the plunger toward the hard stop. Techniques may include determining a time to output a liquid drug from the delivery pump device; generating a control signal to actuate the delivery pump device; applying a control signal to the pump mechanism; determining that a control signal is to be removed from the pump mechanism; and delivering the liquid drug.
A61M 5/145 - Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. by means of pistons
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
F03G 7/06 - Mechanical-power-producing mechanisms, not otherwise provided for or using energy sources not otherwise provided for using expansion or contraction of bodies due to heating, cooling, moistening, drying, or the like
47.
MEDICATION DELIVERY SYSTEM WITH GRAPHICAL USER INTERFACE
A system for automatically delivering medication to a user is disclosed. A sensor worn by the user can collect information regarding the user. A user device, for example, a smartphone, executes a user application that uses the collected information to determine an amount of medication to provide to the user. The user application includes a graphical user interface that allows the user to easily interact with the user application to specify various aspects of the delivery of the medication. The user application controls a wearable drug delivery device to dispense the medication to the user.
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
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 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
48.
AN ON-BODY DRUG DELIVERY DEVICE WITH ANTENNAS SECURED OUTSIDE OF A HOUSING FOR WIRELESS COMMUNICATIONS
An on-body drug delivery device may have one or more antennas secured outside a housing of the on-body drug delivery device for facilitating wireless communications. The one or more antennas may be secured to an adhesive pad that adheres the on-body drug delivery device to a user. Alternatively, the one or more antennas may be secured to a portion of the housing for the on-body drug delivery device. In such instances, the one or more antennas may pass through one or more holes in the housing to facilitate an electrical connection with a component, like a wireless communications transceiver, inside the housing. Alternatively, wireless communications with the one or more antennas and the component may be used.
H01Q 1/27 - Adaptation for use in or on movable bodies
H01Q 1/44 - ANTENNAS, i.e. RADIO AERIALS - Details of, or arrangements associated with, antennas using equipment having another main function to serve additionally as an antenna
A61B 5/00 - Measuring for diagnostic purposes ; Identification of persons
49.
INTEGRATION OF A MEDICAMENT DELIVERY DEVICE WITH A SMARTWATCH AND A VEHICLE INFOTAINMENT SYSTEM
The exemplary embodiments may provide a smartwatch or a vehicle infotainment system with management and data inspection capabilities for a medicament delivery system. A user may view medicament delivery history and analyte level history via the smartwatch or auto mobile infotainment system. In addition, a user may calculate a medicament dosage and prompt delivery of the medicament bolus dosage via the smartwatch or vehicle infotainment system. Notifications also may be delivered to the user via the smartwatch and vehicle infotainment system.
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 20/10 - 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
50.
SCHEDULING OF MEDICAMENT BOLUS DELIVERIES BY A MEDICAMENT DELIVERY DEVICE AT FUTURE DATES AND TIMES WITH A COMPUTING DEVICE
Exemplary embodiments may enable a user to schedule medicament bolus deliveries, such as insulin boluses, for future dates and times. The exemplary embodiments may provide the ability to delay a scheduled medicament bolus delivery by short periods of time. The user may reschedule a scheduled medicament bolus delivery by entering a new date and/or time for the medicament bolus delivery. Still further, a user may cancel a scheduled medicament bolus delivery. In addition, exemplary embodiments may enable multiple medicament bolus deliveries to be viewed and managed.
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 20/10 - 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 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
51.
BATTERY ANTENNA ARRANGEMENT FOR AN ON BODY MEDICAL DEVICE
One or more button cell batteries may be used in an on-body medical device like a drug delivery device to act as an antenna for wireless communications. Since the one or more batteries are already present in the on-body medical device, no additional real estate on the printed circuit board is required for the antenna. In some exemplary embodiments, a single button cell battery is used as an antenna, and in other embodiments, multiple button cell batteries are used as the antenna. For example, a single button cell battery may be used as part of a monopole antenna. Multiple button cell batteries may be used as part of a dipole antenna.
H01Q 1/44 - ANTENNAS, i.e. RADIO AERIALS - Details of, or arrangements associated with, antennas using equipment having another main function to serve additionally as an antenna
52.
ADHESIVE PAD WITH A METALLIC COIL FOR SECURING AN ON-BODY MEDICAL DEVICE
Exemplary embodiments may provide an adhesive pad that is designed to be used with an on-body medical device. The adhesive pad may partially or fully surround a perimeter of the onbody medical device. The adhesive pad may be the primary mechanism or may provide an additional mechanism for helping to secure the on-body medical device to the user. In addition, the adhesive pad may include a metallic coil, such as a metal loop, that is woven into the adhesive pad or otherwise inserted into or secured to the adhesive pad. The metallic coil may play multiple roles. First, the metallic coil may act as an antenna to facilitate wireless communications with the on-body medical device, such as NFC communications. In addition, the metallic coil may serve as a power source for electric components positioned on the adhesive pad.
H01Q 1/44 - ANTENNAS, i.e. RADIO AERIALS - Details of, or arrangements associated with, antennas using equipment having another main function to serve additionally as an antenna
A61B 5/00 - Measuring for diagnostic purposes ; Identification of persons
53.
DRUG DELIVERY DEVICE INCLUDING RESERVOIR WITH FLEXIBLE LINING
Embodiments of the present disclosure relate to techniques, processes, devices or systems for pump devices for providing a fixed volume of fluid, which is delivered and refilled within one pumping cycle. In one approach, a wearable drug delivery device may include a reservoir configured to store a liquid drug, and a drive mechanism coupled to the reservoir for receiving the liquid drug. The drive mechanism may include a housing defining a chamber, the housing including an inlet valve operable to receive the liquid drug and an outlet valve operable to expel the liquid drug from the chamber, and a resilient sealing member within the chamber. The drive mechanism may further include a shape memory wire coupled to the resilient sealing member, wherein the shape memory wire is operable to bias the resilient sealing member within the chamber.
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
A61M 5/165 - Filtering accessories, e.g. blood filters, filters for infusion liquids
54.
DEVICE AND METHODS FOR A SIMPLE MEAL ANNOUNCEMENT FOR AUTOMATIC DRUG DELIVERY SYSTEM
Processes and devices are disclosed that are configured to respond to changes in a user's blood glucose caused by ingestion of a meal. Ingestion of the meal may be announced by a user input or by a meal detection algorithm that requires no user input. The responsive device and processes determine a carbohydrate-compensation insulin dosage based on a user's blood glucose history, external data related to the user's meal history, or based on a user's response to previous carbohydrate-compensation insulin dosages. In addition, a correction insulin dosage may be calculated to cover any gap between a starting blood glucose and a target blood glucose. A user's response to a sum of the carbohydrate-compensation insulin dosage and the correction insulin dosage may be delivered. Based on the user's response, the disclosed examples may determine modifications to the carbohydrate-compensation insulin dosage, the correction insulin dosage, or both.
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 20/10 - 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
Embodiments of the present disclosure relate to techniques, processes, devices or systems for pump devices for providing a fixed volume of fluid, which is delivered and refilled within one pumping cycle. In one approach, a wearable drug delivery device may include a reservoir configured to store a liquid drug, and a drive mechanism coupled to the reservoir for receiving the liquid drug. The drive mechanism may include a housing defining a chamber, the housing including an inlet valve operable to receive the liquid drug and an outlet valve operable to expel the liquid drug from the chamber, and a resilient sealing member within the chamber. The drive mechanism may further include a shape memory wire coupled to the resilient sealing member, wherein the shape memory wire is operable to bias the resilient sealing member within the chamber.
Disclosed are systems, devices, methods and computer-readable medium products that implement a vibrational event by a wearable drug delivery device. The wearable drug delivery device includes vibrational actuators that vibrate in response to a control signal from a controller. The controller may be controlled by an external device that issues command signals with instructions related to settings of the vibrational event. The vibrational event settings may be modified based on signals received from sensors on the wearable drug delivery device. The vibrational events may be implemented as an element of a site maintenance plan that alleviates the degeneration of tissue at one or more body attachment sites of the wearable drug delivery device.
Embodiments of the present disclosure relate to approaches for more efficiently measuring glucose levels using a wearable drug delivery device. In some embodiments, the wearable drug delivery device may include a needle deployment component including a cannula and an optical conduit deployable into a user, the cannula operable to deliver a liquid drug to the user. The wearable drug delivery device may further include a glucose monitor including an optical sensor, the optical sensor operable to measure a light output received via the optical conduit.
Methods and apparatuses for performing an insertion process for a plurality of penetrating elements are described. For example, a wearable fluid infusion device may include a cannula and/or needle for infusing a fluid into a patient and a sensor for sensing a physical characteristic of the patient. A non-limiting example of a fluid may be or may include insulin. An illustrative and non-restrictive example of a physical characteristic may include a blood glucose level. The wearable infusion device may be configured to facilitate insertion of the multiple penetrating elements, such as a cannula and a sensor, in a single simultaneous insertion step instead of requiring individual insertion steps for each of multiple penetrating elements. Other embodiments are described.
The exemplary embodiments may provide a secure framework for devices in a drug delivery system to wirelessly communicate. The secure framework may use encrypted keys to carry credentials and to specify the rights of the devices presenting the credentials. The devices in the drug delivery system present the keys at the time that they wish to wirelessly communicate with other devices in the drug delivery system. The devices receiving such keys, decrypt the keys and verify if the credentials are valid. If the credentials are valid, a wireless communication session between devices may be established.
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
Embodiments of the present disclosure relate to techniques, processes, devices or systems for automating fluid delivery without the use of an external interface device. In one approach, a wearable drug delivery device may include a reservoir configured to store a liquid drug, a pump mechanism coupled to the reservoir and operable to expel the liquid drug from the reservoir, and a mechanical triggering device engageable by a user. The mechanical triggering device is operable to change between a first configuration and a second configuration to control deployment of a needle to deliver the liquid drug into a patient.
Disclosed are systems, devices, methods and computer-readable medium products that compensate for consumption of a meal by providing a reduced-constraint meal bolus dosage. The reduced-constraint meal bolus dosage is determined using post-prandial safety constraints that are reduced based on an indication that a meal has been consumed. The post-prandial safety constraints are intended to protect users from overdelivering or underdelivering insulin to the user. The determinations may be performed by a control algorithm-based drug delivery system that enables automatic delivery of a drug, such as insulin or the like.
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
63.
SYSTEMS AND METHODS FOR ACTIVATING DRUG DELIVERY DEVICES
Embodiments of the present disclosure relate to approaches for transitioning a drug delivery device from a low-energy sleep state to a high-energy active state. In some embodiments, a system may include a drug delivery device, the drug delivery device including a pump mechanism coupled to a reservoir for expelling a liquid drug from the reservoir; and an activation component communicatively coupled to the pump mechanism. The activation component may include at least one of a sensor and a mechanical activation device, and a wakeup circuit operable to receive an input from the sensor or the mechanical activation device, wherein the input indicates a change in a device characteristic. Based on the change in the device characteristic, the wake-up circuit may be further operable to transition the drug delivery device from a low-energy state to an active state.
The disclosed embodiments are directed to a wearable automatic drug delivery device configured to provide basal-only dosing of insulin. In a primary embodiment, the wearable drug delivery device is configured to provide automatic operation and provides audible alerts and visual status indicators to the patient. In other embodiments, the patient may have some degree of control over the operation of the device by providing tapping gestures on housing of the device. In yet another embodiment, the patient may provide input and receive status from the device via an application executing on a portable computing device in wireless communication with the wearable drug delivery device.
Exemplary embodiments may perform data analytics on data regarding a user of a medicament delivery device and data regarding other users of like medicament delivery devices to provide insights and guide management of the medicament delivery device for the user. The data analytics may be so called "big data" analytics that are performed on large data sets. The data analytics may be performed on various types of data to help determine what actions, if any, the remote management should take. The data analytics may be performed by the software on the remote management device or by other computational resources, such as by other servers or cloud computing resources. Exemplary embodiments may provide for remote management of a medicament delivery device. The management may be remote in that the management is performed via a remote management device, such as a computing device, that is remotely located from the medicament delivery device.
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
66.
OPEN-LOOP INSULIN DELIVERY BASAL PARAMETERS BASED ON INSULIN DELIVERY RECORDS
Disclosed are techniques and a device operable to determine a total amount of insulin delivered to the user over a predetermined time period. The total amount of insulin includes a total basal dosage delivered in basal dosages and a total bolus dosage delivered in bolus dosages over the predetermined time period. A proportion of the total amount of insulin delivered to the user provided via the total basal dosage amount over the predetermined time period is calculated. In response determining the proportion of the total amount of insulin attributed to the total basal dosage amount of insulin exceeds a threshold, an average basal dosage to be delivered within a subsequent time period that is approximately equal to the threshold may be determined. An instruction may be generated and output to deliver a modified basal dosage that substantially maintains the average basal dosage over the subsequent time period.
A61M 5/00 - 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
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration, pH-value
G16H 20/17 - ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients delivered via infusion or injection
G16H 40/63 - 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
67.
INITIAL TOTAL DAILY INSULIN SETTING FOR USER ONBOARDING
Disclosed are techniques to establish initial settings for an automatic insulin delivery device. An adjusted total daily insulin (TDI) factor may be determined. Based on a result of a comparison of the adjusted TDI factor to a maximum algorithm delivery threshold, a TDI dosage may be set. Blood glucose measurement values may be collected from a sensor over a period of time. A level of glycated hemoglobin of the blood may be determined based on the obtained blood glucose measurement values. In response to the level of glycated hemoglobin, the set TDI dosage may be modified. A subsequent control signal including the modified TDI dosage may be output to actuate delivery of insulin.
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 50/30 - ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for individual health risk assessment
Disclosed are examples of a device, a system, methods and computer-readable medium products operable to implement functionality to determine and respond to a purpose of a meal. An algorithm or application may receive data that may include data related to a meal purpose from data sources and determine whether any of the data received from the plurality of data sources was received from a direct data source or an indirect data source. The data may be evaluated to determine a purpose of the meal. Based on the results of the evaluation, instructions may be generated to provide an appropriate response based on the determined purpose of the meal. The generated instructions to provide the appropriate response based on the determined purpose of the meal may be output.
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
69.
DUAL HORMONE DELIVERY SYSTEM FOR REDUCING IMPENDING HYPOGLYCEMIA AND/OR HYPERGLYCEMIA RISK
The exemplary embodiments attempt to identify impending hypoglycemia and/or hyperglycemia and take measures to prevent the hypoglycemia or hyperglycemia. Exemplary embodiments may provide a drug delivery system for delivering insulin and glucagon as needed. The drug delivery system may deploy a control system that controls the automated delivery of insulin and glucagon to a patient by the drug delivery system. The control system seeks among other goals to avoid the user experiencing hypoglycemia or hyperglycemia. The control system may employ a clinical decision support algorithm to control delivery of insulin and glucagon to reduce the risk of hypoglycemia or hyperglycemia and to provide alerts to the user when needed. The control system assesses whether the drug delivery system can respond enough to avoid hypoglycemia or hyperglycemia and generates alerts when manual action is needed to avoid hypoglycemia or hyperglycemia.
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
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
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
70.
PERSONALIZED REDUCTION OF HYPOGLYCEMIA AND/OR HYPERGLYCEMIA IN A CLOSED LOOP SYSTEM
Exemplary embodiments described herein relate to a closed loop artificial pancreas system. The artificial pancreas system seeks to automatically and continuously control the blood glucose level of a user by emulating the endocrine functionality of a healthy pancreas. The artificial pancreas system uses a closed loop control system with a cost function. The penalty function helps to bound the infusion rate of insulin to attempt to avoid hypoglycemia and hyperglycemia. However, unlike conventional systems that use a generic or baseline parameter for a users insulin needs in a cost function, the exemplary embodiments may use a customized parameter in the cost function that reflects the individualized insulin needs of the user. The use of the customized parameter causes the cost function to result in insulin dosages over time better suited to the individualized insulin needs of the user. This helps to better avoid hypoglycemia and hyperglycemia.
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
71.
COMPENSATION FOR MISSING READINGS FROM A GLUCOSE MONITOR IN AN AUTOMATED INSULIN DELIVERY SYSTEM
Exemplary embodiments may address the problem of missing blood glucose concentration readings from a glucose monitor that transmits blood glucose concentration readings over a wireless connection due to problems with the wireless connection. In the exemplary embodiments, an automated insulin delivery (AID) device uses an estimate in place of a missing blood glucose concentration reading in determining a predicted future blood glucose concentration reading for a user. Thus, the AID device is able to operate normally in generating insulin delivery settings despite not receiving a current blood glucose concentration reading for a current cycle. There is no need to suspend delivery of insulin to the user due to the missing blood glucose concentration reading.
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
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
72.
USE OF FUZZY LOGIC IN PREDICTING USER BEHAVIOR AFFECTING BLOOD GLUCOSE CONCENTRATION
In an automated insulin delivery device, fuzzy logic may be applied to the responding to the possibility of a user taking additional action that may affect the blood glucose concentration Fuzzy sets may be defined for empirically derived different likelihoods of the user taking such additional action based on correlated factors. A membership function may be provided for each fuzzy set. The membership function may provide a probability of membership in the set based on a parameter. Each fuzzy set may have a response that is reflective of the likelihood of additional user action associated with the fuzzy set. The responses by the AID device to each of these cases may reflect the probability of each such case occurring as evidenced by empirical data.
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 50/50 - 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
73.
ACCURATE PREDICTION OF QUANTITY AND TIMING OF INSULIN RESERVOIR REFILLS
Exemplary embodiments may provide an improved approach to automated insulin delivery by more accurately estimating the total daily insulin (TDI) of a user. As a result, less insulin is wasted by the delivery system, and the estimate of TDI more closely matches a users actual daily insulin needs. Hence, the user need not refill the insulin reservoir excessively or need not fret unnecessarily about running out of insulin prematurely. The estimate relies on the history of actual automated insulin deliveries and thus reflects the actual insulin delivered to the user more accurately than conventional approaches.
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
74.
MEAL INSULIN DETERMINATION FOR IMPROVED POST PRANDIAL RESPONSE
Disclosed are a device, system, methods and computer-readable medium products that provide techniques to implement functionality to receive information related to a meal and delivery of a meal bolus. The received information may be stored and utilized in the generation of insulin delivery profiles. An estimate a mealtime insulin need based on the generated insulin delivery profiles may be generated. A dose of insulin may be determined that satisfies an estimated mealtime insulin need based on the generated insulin delivery profiles. The determined dose of insulin may be output at a time corresponding to a mealtime.
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
75.
PREDICTION OF MEAL AND/OR EXERCISE EVENTS BASED ON PERSISTENT RESIDUALS
Exemplary embodiments provide an approach to predicting meal and/or exercise events for an insulin delivery system that otherwise does not otherwise identify such events. The insulin delivery system may use a model of glucose insulin interactions that projects estimated future glucose values based on the history of glucose values and insulin deliveries for the user. The predictions of meal events and/or exercise events may be based on residuals between actual glucose values and predicted glucose values. The exemplary embodiments may calculate a rate of change of the residuals over a period of time and compare the rate of change to thresholds to determine whether there likely has been a meal event or an exercise event. The insulin delivery system may then take measures to account for the meal or exercise by the user.
G16H 20/17 - ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients delivered via infusion or injection
76.
TECHNIQUES FOR IMPROVED AUTOMATIC DRUG DELIVERY PERFORMANCE USING DELIVERY TENDENCIES FROM PAST DELIVERY HISTORY AND USE PATTERNS
Disclosed are devices, a system, methods and computer-readable medium products that provide techniques to implement functionality to determine when to softened upper bounds of drug delivery and how much to soften the upper bound. Future blood glucose measurement values may be predicted by calculating deviations between predicted blood glucose measurement values and additional blood glucose measurement values. A gain parameter may be determined for use with a model of predicting a users blood glucose measurement values and determining future drug dosages. Safety constraints may be determined based on an evaluation of missing blood glucose measurement values. In addition, safety constraints may be determined based on an evaluation of a user's increased interaction with an automatic drug delivery device. A bolus uncertainty metric to determine an amount of insulin to be provided in a bolus dosage in response to a bolus request may be calculated.
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 50/00 - ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics
77.
TECHNIQUES AND DEVICES PROVIDING ADAPTIVITY AND PERSONALIZATION IN DIABETES TREATMENT
Disclosed are a device, system, methods and computer-readable medium products that provide an updated insulin-to-carbohydrate ratio and an updated total daily insulin. The described processes may be used for periodic updating of the insulin-to-carbohydrate ratio and the total daily insulin. The insulin-to-carbohydrate ratio and/or the total may be used in the calculation of new doses of insulin that a drug delivery device may be commanded to deliver to a user.
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
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 40/63 - 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
Disclosed herein are wearable drug delivery devices and methods for component positioning of a linear shuttle pump. In some approaches, a pump may include a pump chamber operably coupled with a piston, and a detent apparatus, wherein the detent apparatus comprises a detent body, a detent arm, and a detent engagement member. The detent engagement member may be retained in direct physical contact with first or second arrest locations of either the detent body or the detent arm. The pump may further include a piston grip coupled to the piston, the piston grip including a grip component engaged with an exterior of the piston. Movement of the piston grip may cause the piston to move axially relative to the pump chamber to control receipt and delivery of a liquid drug.
Disclosed are a device, a computer-readable medium, and techniques that provide an onboarding process and an adaptivity process for a drug delivery device. A processor executing an onboarding process determines whether a history of delivered insulin to a user meets certain sufficiency requirements. The onboarding process enables a processor to cause the drug delivery device to administer doses of insulin to a user according to an initial total daily insulin dose calculation that is determined based on the sufficiency of the insulin delivery history. The initial total daily insulin may be adapted according to the adaptivity process as new insulin delivery is collected. The insulin delivery history, when sufficient, may be used to set total daily insulin dosages that enable automated insulin delivery upon replacement of a drug delivery device. The adaptivity process may be implemented to modify an initial insulin delivery doses to provide adapted insulin delivery doses.
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
Disclosed are a system, methods and computer-readable medium products that provide bolus dosage calculations by a control algorithm-based drug delivery system that provides automatic delivery of a drug, such as insulin or the like, based on sensor input. Blood glucose measurement values may be received at regular time intervals from a sensor. Using the blood glucose measurements, the control algorithm may perform various calculations and determinations to provide an appropriate bolus dosage. The appropriate bolus dosage may be used to respond to a trend in a trajectory of blood glucose measurements. In addition, a bolus dosage may also be determined by the disclosed device, system, method and/or computer-readable medium product in response to an indication that a user consumed a meal.
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
81.
DRUG DELIVERY SHUTTLE PUMP SYSTEM AND VALVE ASSEMBLY
A multiple pulse volume shuttle pump powered by a shape memory alloy (SMA) wire is disclosed. In some embodiments, a shuttle pump system may include a pump chamber, a valve operable with the pump chamber, and a wire coupled to a valve shaft of the valve for controlling a position of the valve. The shuttle pump system may further include a pin disposed within an inset pathway of a cam, wherein the pin is moveable between multiple positions of the inset pathway in response to actuation of the valve shaft.
F04B 19/00 - Machines or pumps having pertinent characteristics not provided for in, or of interest apart from, groups
F04B 9/04 - Piston machines or pumps characterised by the driving or driven means to or from their working members the means being mechanical the means being cams, eccentrics or pin-and-slot mechanisms
F04B 17/00 - Pumps characterised by combination with, or adaptation to, specific driving engines or motors
A drug delivery device which may include an Inertial Measurement Unit (IMU) is provided. The IMU may include an accelerometer, a magnetometer, or a gyroscope. Motion parameters may be detected when the drug delivery device is shipped, being prepared for activation for use, or during use. The IMU may provide data indicative of a rapid deceleration, such as when a package containing the drug delivery device is dropped, or some other physical event experienced by the drug delivery device. The drug delivery device may also include internal or external pressure sensors or a blood glucose sensor that may coordinate with the IMU to provide additional feedback regarding the status of the device or user. A controller of the drug delivery device may generate a response depending on the particular parameters being monitored or may change device operational parameters as a result of detected system events.
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 wearable drug delivery device, techniques, and computer-readable media that provide an application that implements a diabetes treatment plan for a user are described. The drug delivery device may include a controller operable to direct operation of the wearable drug delivery device. The controller may provide a selectable activity mode of operation for the user. Operation of the drug delivery device in the activity mode of operation may reduce a likelihood of hypoglycemia during times of increased insulin sensitivity for the user and may reduce a likelihood of hyperglycemia during times of increased insulin requirements for the user. The activity mode of operation may be manually activated by the user or may be activated automatically by the controller. The controller may automatically activate the activity mode of operation based on a detected activity level of the user and/or a detected location of the user.
Disclosed are examples of valve systems and methods of operating the respective valve systems. An example valve system may include a valve body, an inlet component, an outlet component and a valve tube. The valve body may include a first void and a second void. The inlet component may be coupled to the first void and the outlet component may be coupled to the second void. The valve tube may include a side port and may be positioned through the valve body and coupled to the first void, the inlet component, the second void, and the outlet component. Other valve system examples may include including a valve body, a first septum, a second septum, a first piston, a second piston and a tube. The disclosed methods describe the interaction of the respective components of the respective valve system example.
F04B 1/02 - Multi-cylinder machines or pumps characterised by number or arrangement of cylinders having two cylinders
F04B 1/04 - Multi-cylinder machines or pumps characterised by number or arrangement of cylinders having cylinders in star- or fan-arrangement
F04B 1/047 - Multi-cylinder machines or pumps characterised by number or arrangement of cylinders having cylinders in star- or fan-arrangement with actuating or actuated elements at the outer ends of the cylinders
F04B 7/00 - Piston machines or pumps characterised by having positively-driven valving
F16K 11/07 - Multiple-way valves, e.g. mixing valves; Pipe fittings incorporating such valves; Arrangement of valves and flow lines specially adapted for mixing fluid with all movable sealing faces moving as one unit comprising only sliding valves with linearly sliding closure members with cylindrical slides
85.
SEMI-RIGID AND FLEXIBLE ELEMENTS FOR WEARABLE DRUG DELIVERY DEVICE RESERVOIR
Disclosed are examples of reservoir and reservoir systems usable with a wearable drug delivery device. An example reservoir may include a flexible component coupled to a shell component. The shell component may include drainage channels to facilitate extraction of the liquid drug from the reservoir. A reservoir system example may include an exoskeleton configured around a flexible reservoir to guide the expansion and collapse of the flexible reservoir. Alternativity, one or more rigid panels may be coupled to corresponding flat surfaces of the flexible reservoir to guide the expansion and collapse of the flexible reservoir. A further reservoir example may include a flexible thin film reservoir having peel-able restraints configured to seal off corresponding sections of the reservoir, sequentially break, enabling the liquid drug to sequentially fill corresponding sections in a controlled and predicable manner. A wearable drug delivery device example suitable for utilizing the described examples is provided.
A61J 1/05 - Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids
Disclosed are examples for a system for drug delivery and components thereof. The system may include an on-body pump device and a secondary unit. The on-body pump device may include a reservoir and a fluid pathway. The reservoir may be configured to hold a liquid drug. The secondary unit may be removably coupled to the on-body pump device. The secondary unit may be configured to receive a prefilled cartridge containing a liquid drug, expel the liquid drug from the prefilled cartridge, and deliver the liquid drug to the reservoir of the on-body pump device via the fluid pathway. Examples of variations to the secondary unit are also disclosed.
Examples of fluid delivery drive system and/or pump system that creates a vacuum in a fluid line for drawing and expelling fluid are provided. The vacuum may be created by separating two components that are positioned within the sealed fluid line. Once the two components are separated and the fluid is contained within the volume created between the separated components, the two components may be shuttled within the sealed volume. The movement of the two components can seal off an inlet to the fluid line and then open a pathway to an outlet from the fluid line while ensuring the created volume between the two components is maintained constant. The two components can then be moved back together to expel the fluid from the created volume through the outlet for delivery, for example, to a patient. Other examples are disclosed and described.
Disclosed are a system, methods and computer-readable medium products that provide safety constraints for an insulin-delivery management program. Various examples provide safety constraints for a control algorithm-based drug delivery system that provides automatic delivery of a drug based on sensor input. Glucose measurement values may be received at regular time intervals from a sensor. A processor may predict future glucose values based on prior glucose measurement values. The safety constraints assist in safe operation of the drug delivery system during various operational scenarios. In some examples, predicted future glucose values may be used to implement safety constraints that mitigate under-delivery or over-delivery of the drug while not overly burdening the user of the drug delivery system and without sacrificing performance of the drug delivery system. Other safety constraints are also disclosed.
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 needle mechanism module for automatically inserting a fluid path into a patient for drug delivery is provided. The needle mechanism module can be a component of a wearable drug delivery device. The needle mechanism module can insert a needle and cannula into the patient responsive to activation of the drug delivery device by a user. After insertion, the needle can be automatically retracted, leaving only the cannula in the patient. As a result, discomfort of the user is reduced.
A wearable drug delivery device that can deliver a liquid drug stored in a container to a patient is provided. The container can be a prefilled cartridge that can be loaded into the drug delivery device by the patient or that can be preloaded within the drug delivery device when provided to the patient. A sealed end of the container is pierced to couple the stored liquid drug to a needle conduit that is coupled to a needle insertion component that provides access to the patient. A drive system of the drug delivery device can expel the liquid drug from the cartridge to the patient through the needle conduit. The drive system can be controlled to provide the liquid drug to the patient in a single dose or over multiple doses.
A low-force, non-displacement, micro/miniature valve and/or pump assembly is provided. A tube component having a first side port coupled to an inlet portion and a second side port coupled to an outlet portion can be selectively moved to alternatively couple the side ports to a first or second piston pump chamber. First and second pistons can be actuated after positioning the tube component to either draw in fluid or push out fluid from either the first or second piston pump chambers during each actuation of the pistons. The fluid can be drawn in from a reservoir and can be expelled to a patient for providing a dose of the fluid to the patient.
F04B 1/02 - Multi-cylinder machines or pumps characterised by number or arrangement of cylinders having two cylinders
F04B 1/04 - Multi-cylinder machines or pumps characterised by number or arrangement of cylinders having cylinders in star- or fan-arrangement
F04B 1/047 - Multi-cylinder machines or pumps characterised by number or arrangement of cylinders having cylinders in star- or fan-arrangement with actuating or actuated elements at the outer ends of the cylinders
F04B 7/00 - Piston machines or pumps characterised by having positively-driven valving
Systems for piercing a septum of a drug delivery device is disclosed. The drug delivery device may include a needle conduit having an end and a drug container having a septum. The septum piercing mechanism may include a needle support operatively coupled to the needle conduit. The septum piercing mechanism may be movable from a first, unactivated configuration to a second, activated configuration. In the unactivated configuration, the septum seals an interior of the drug container from the end of the needle conduit. In the activated configuration, the end of the needle conduit pierces through the septum placing the needle conduit in fluid communication with the drug container. In one embodiment, activation may cause the needle support to move towards the drug container. In one embodiment, the needle support may be moved by a biasing member. Alternatively, in another embodiment, the needle support may be moved by a cam mechanism.
Drug delivery systems with reduced hold-up volumes are provided. The drug delivery systems include a cartridge (202) configured to hold a liquid drug. A cartridge stopper (702) is positioned in a first portion of the cartridge. A needle guide component (704) is positioned within the cartridge stopper. A needle (706) is positioned within a central opening (708) of the needle guide. A plunger (714) is positioned in a second portion of the cartridge. The plunger includes a fluid path pocket (718) facing and aligned with the central opening of the needle guide component. The plunger is driven toward the cartridge stopper to expel the liquid drug from the cartridge through the needle. An end of the needle can be positioned within the fluid path pocket when the plunger is pushed against the cartridge stopper, ensuring that only a small volume of the liquid drug remains in the cartridge when delivery of the liquid drug is completed.
An improved basal insulin management system and an improved user interface for use therewith are provided. User interfaces are provided that dynamically display basal rate information and corresponding time segment information for a basal insulin program in a graphical format. The graphical presentation of the basal insulin program as it is being built by a user and the graphical presentation of a completed basal insulin program provides insulin management information to the user in a more intuitive and useful format. User interfaces further enable a user to make temporary adjustments to a predefined basal insulin program with the adjustments presented graphically to improve the user's understanding of the changes. As a result of being provided with the user interfaces described herein, users are less likely to make mistakes and are more likely to adjust basal rates more frequently, thereby contributing to better blood glucose control and improved health outcomes.
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
95.
DRUG DELIVERY SYSTEMS WITH SEALED AND STERILE FLUID PATHS AND METHODS OF PROVIDING THE SAME
The present disclosure relates generally to the field of drug delivery. In particular, the present disclosure relates to a drug delivery system that includes a sealed and sterile fluid path attached to a drug-loaded container. The disclosure further relates to methods for sterilizing a portion of the drug delivery system without exposing the drug-loaded container to harmful sterilization parameters.
A61M 5/00 - 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
A61M 5/24 - Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or cartridges, e.g. automatic
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
A multi-stage drug delivery system having a cartridge and multiple plungers positioned in the cartridge and spaced apart from one another is provided. A first plunger, a second plunger, and the cartridge form a first chamber storing a first drug. The second plunger and the cartridge form a second chamber storing a second drug. A cannula pierces the first plunger to access the first drug. As the first plunger is driven toward the second plunger, the first drug is expelled from the first chamber for delivery to a patient through the cannula. After expelling the first liquid drug, the cannula can pierce the second plunger to access the second drug. As the first and second plungers are together driven toward a closed end of the cartridge, the second liquid drug is expelled from the second chamber for delivery to the patient through the cannula.
A wearable drug delivery device for monitoring unintended over-delivery and/or under-delivery of a stored liquid drug are provided. An absolute pressure sensor can be positioned within the fluid path of the drug delivery device. The absolute pressor sensor can detect both ambient pressure (e.g., absolute or atmospheric pressure) and relative pressure (gage or pumping pressure). Based on the detected pressures, the effects of external ambient pressure on air with the fluid path can be determined during both intended drug delivery events and unintended drug delivery events. In turn, under-delivery and/or over-delivery of the liquid drug can be determined. Based on the severity of the determined under-delivery or over-delivery of the liquid drug, alarms indicating different urgencies can be provided to the user.
Variable fill drug delivery devices for delivering a therapeutic agent to a patient are provided. A variable fill drug delivery device includes a drug container to store a variable amount (or user-selectable amount) of a therapeutic agent. A plunger of the variable fill drug delivery device is positioned in the drug container. An infusion engine of the variable fill device is coupled to the plunger. The infusion engine retains the plunger prior to activation of the variable fill drug delivery device and releases the plunger after activation of the variable fill drug delivery device. After activation, the infusion engine drives the plunger from a first position within the drug container to a second position within the drug container to expel the variable amount of the therapeutic agent from the drug container for delivery to a patient.
Systems and methods for monitoring an operational state and/or a fill status of a drug container of a drug delivery device are provided. The drug container can hold a liquid drug. A plunger can be positioned within the drug container. A drive system can advance the plunger to expel the liquid drug from the container. A monitoring system can detect a movement and/or a position of the plunger and/or any component coupled to the plunger. The detection can enable determination of an amount of liquid drug that has been expelled and/or an amount of liquid drug remaining in the drug container. Dosing rates, flow rates, and dosage completion can also be determined.
Plunger systems for expelling a liquid drug from a drug container within a wearable drug delivery device are provided. A rotation system coupled to a plunger rotates the plunger about a central axis of the plunger to overcome a static friction between the plunger and the drug container. After rotating the plunger, a drive system moves the plunger forward into the drug container to expel the liquid drug for delivery to the patient. A collapsible plunger includes a cavity. A radial torsion spring positioned in the cavity can provide an outward radial force on the collapsible plunger. The cavity enables the collapsible plunger to compress radially when entering and passing through a region of a drug container having a relatively narrower width. The radial torsion spring can radially expand the collapsible plunger when entering and passing through a region of the drug container having a relatively wider width.
patents
