Exemplary embodiments may terminate application of an electric pulse to a shape memory alloy (SMA) element that causes actuation of a medicament pump based on resistance values unlike conventional approaches that rely on a mechanical mechanisms to trigger termination of the application of the electric pulse. The magnitude of the resistance values, the rate of change (RoC) of the resistance values, the temperature of the SMA element, the time that has passed since initial 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 in exemplary embodiments. The monitoring of the resistance of an unactuated SMA element may be used to determine when to initiate and when to terminate application of an electrical pulse to the other SMA element.
A method may include displaying to a user an interface at which the user inputs a fear of hypoglycemia index (FHI), the FHI corresponding to an acceptable probability of a blood glucose level being below a threshold blood glucose level. The method may also include receiving blood glucose data for a person with diabetes (PWD). The method may additionally include calculating a probability of the PWD having a blood glucose level below the threshold blood glucose level based on the variability of the received blood glucose data. The method may also include setting one or more target blood glucose levels to align the probability of the PWD having a blood glucose level below the threshold blood glucose level with the acceptable probability associated with the user input FHI. The method may additionally include delivering insulin, using the insulin delivery device, based on the target blood glucose level.
A61M 5/145 - Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. by means of pistons
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 40/67 - 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
A drug delivery drive mechanism including a ratchet wheel including a plurality of teeth, a ratchet arm including a first prong and a second prong, wherein the first prong is operable interact with a tooth of the plurality of teeth to rotate the ratchet wheel in a circular direction, and the second prong is operable to interact with another tooth of the plurality of teeth to further rotate the ratchet wheel in the circular direction.
A method includes receiving up-to-date blood glucose data for a PWD, determining basal insulin dosages for the PWD based on a baseline basal rate, delivering the basal insulin dosages to the PWD, modifying a target blood glucose level based on variability of blood glucose data for the PWD, receiving a temporary override indicating a user preference to reduce the likelihood that the PWD has a hypoglycemic event or a user preference to reduce the likelihood that the PWD has a hyperglycemic event, determining a temporary target blood glucose level based on the input—greater than the modified blood glucose level if the preference is to reduce the likelihood of a hypoglycemic event—lower than the modified target blood glucose level if the preference is to reduce the likelihood that of a hyperglycemic event. The method includes delivering basal insulin for the temporary period of time based on the temporary target.
A61M 5/145 - Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. by means of pistons
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 40/67 - 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 herein is a system and method for calculating an expected peak blood glucose level of 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.
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 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
In one implementation, an insulin delivery system using an on-body network includes an insulin delivery device that is adapted to administer dosages of insulin to a patient; a controller that is adapted to control operation of the insulin delivery device, to establish a first network connection in which the controller acts in a central role, and to establish a second network connection in which the controller acts in a peripheral role; one or more peripheral devices that are adapted to generate patient data related to blood glucose levels and to transmit the patient data wirelessly over the first network connection, the peripheral devices acting in a peripheral role over the first network connection; and a mobile application installed on a mobile computing device that is programmed to communicate with the controller over the second network connection, the mobile application communicating in a central role over the second network connection.
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
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
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.
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.
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.
A61M 5/315 - Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod; Appliances on the rod for facilitating dosing
G16H 20/17 - ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients delivered via infusion or injection
13.
METHOD FOR DETECTING OCCLUSIONS IN A FLUID PATH USING BLOOD GLUCOSE READINGS
Disclosed herein is a system and method implementing a software-based method for detecting or confirming the detection of occlusions in the fluid path of an automatic drug delivery system. The invention uses real time glucose readings from a continuous glucose monitor in collaboration with past insulin delivery history and user indications of ingestion of carbohydrates, to determine cases where the user's glucose concentration is not being sufficiently impacted by the expected insulin delivery, which may indicate a significant pump site issue.
G05B 13/04 - Adaptive control systems, i.e. systems automatically adjusting themselves to have a performance which is optimum according to some preassigned criterion electric involving the use of models or simulators
G16H 40/63 - ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for local operation
G16H 50/50 - ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for simulation or modelling of medical disorders
14.
SYSTEM AND METHOD FOR ADJUSTING INSULIN DELIVERY TO ACCOUNT FOR INSULIN RESISTANCE
Disclosed herein is a method, implemented in an automatic drug delivery system, for determining insulin resistance of a user and adjusting parameters of the medication delivery algorithm of the automatic drug delivery system based on the determined insulin resistance. A self-guided test is administered similar to the Kraft test which determines if the quantity of insulin delivered during a post-prandial period after ingestion of a quantity of fast-acting carbohydrates is sufficient to lower the user's blood glucose level to a baseline 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
Disclosed are techniques, devices and systems that modify an insulin delivery schedule based on how sensitive a diabetic user may to fluctuations in their total daily insulin or fluctuations in their blood glucose measurement values. As a control algorithm calculates how to adapt the calculation of the user's total daily insulin, a rate of adaptivity function may be used in the calculation. The rate of adaptivity may depend on a number of factors and the disclosed techniques, devices and systems enable calculation of the rate of adaptivity to provide effective implementation or modification of a diabetic treatment plan.
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.
In exemplary embodiments, an on-body medical device has an adhesive layer with adhesives of two or more strengths. In some of the exemplary embodiments, a stronger adhesive is positioned on the adhesive layer where additional strength is needed, such as around the perimeter of the adhesive layer to prevent premature peeling. A weaker adhesive is positioned on other portions of the adhesive layer where there is no need for the strength of the stronger adhesive. In other exemplary embodiments, three strengths of adhesives are used on the adhesive layer. An intermediate strength adhesive is used along with a stronger adhesive and a weaker adhesive. The intermediate strength adhesive may be used in areas where the weaker adhesive does not provide enough strength but the full strength of the stronger adhesive is not needed.
Disclosed are a device, system, methods and computer-readable medium products that provide techniques to implement functionality to receive blood glucose measurements over a period of time. An average of missing blood glucose measurement values may be maintained over a predetermined time period. A count of a number of missing blood glucose measurement values over a period of time may be established. A controller may calculate a divergence of the number of missing blood glucose measurement values over the period of time from the average of missing blood glucose measurements over the predetermined time period. Based on a value of the divergence, a determination that a safety constraint for delivery of insulin is to be reduced. The safety constraint may be reduced by a predetermined percentage. An instruction to deliver an insulin dosage may be generated according to the reduced safety constraint may be forwarded to a wearable drug delivery device.
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.
A device for delivering fluid to a user may include a reservoir that holds the fluid and a plunger received in the reservoir. As the plunger is driven into the reservoir, the fluid is driven out; similarly, as the reservoir is filled, the plunger is driven out of the reservoir. The plunger may be moved into or out of the reservoir by the action of a lead screw. The lead screw may include multiple starts.
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.
The exemplary embodiments provide thermal weld structures that help prevent tearing of the adhesive layer of an on-body medical device when subject to lateral forces. These thermal weld structures help reduce the tearing by providing sacrificial thermal weld structures that will absorb forces and then potentially fail to thereby diffuse some of the lateral forces. The sacrificial thermal weld structures may take different forms. For instance, the sacrificial thermal weld structures may be gradient thermal weld structures where the amount of material melted in the gradient thermal weld structures decreases as a gradient along a dimension of the structures, such as their length. In some alternative embodiments, the width of the gradient thermal weld structure may vary instead of the height, or in conjunction with the height. In other exemplary embodiments, the sacrificial thermal weld structures may be dot thermal weld structures.
Disclosed herein is a system for detecting and handling occlusions in the fluid path of the drug delivery device. The system includes a sensor disposed in-line with the fluid path for determining a change in pressure within the fluid path. The system further includes a machine learning model for analyzing readings from the sensor to detect and classify an occlusion in the fluid path based on the time series of readings from the sensor indicating a change in pressure. The system further takes remedial action to either compensate for the occlusion, clear the occlusion, or inform the user of the existence of the occlusion and recommends a course of action to the user.
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
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
24.
BLOOD GLUCOSE RATE OF CHANGE MODULATION OF MEAL AND CORRECTION INSULIN BOLUS QUANTITY
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.
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 10/60 - ICT specially adapted for the handling or processing of patient-related medical or healthcare data for patient-specific data, e.g. for electronic patient records
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration, pH-value
25.
INFORMING A USER OF ANTICIPATED INSULIN DELIVERY ACTIONS AND PROVIDING RECOMMENDED USER ACTIONS
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.
Disclosed herein is a method, implemented in an automated drug delivery system for determining a risk of a hypoglycemic or hyperglycemic condition based on risk factors calculated each time a new blood glucose reading is received and providing an alert to the user should a risk be determined. The risk factors may include the current CGM reading, the trend of CGM readings, the amount of insulin-on-board of the user and the accuracy of previous alerts provided to the user. The method may be modified to provide the risk of hypoglycemia if the user were to engage in exercise or other physical activities.
Disclosed are systems and processes for an optical monitoring system for monitoring the dispensing of fluid from a fluid delivery device For example, a fluid delivery device may include a reservoir storing a fluid, a pump fluidically coupled to the reservoir, the pump comprising a drive mechanism to force the fluid from the reservoir, and an optical monitoring system. The optical monitoring system may include at least one light source operative to emit light incident on at least one element of the drive mechanism, and at least one sensor configured to receive the light reflecting off of the at least one element, wherein the at least one light source and the at least one sensor are arranged on a same side of the at least one element. Other embodiments are described.
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.
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 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
Disclosed are techniques, devices and systems that obtain a glucose measurement history and a liquid drug delivery history. An expected drug delivery amount may be calculated based on the obtained glucose measurement history and the obtained liquid drug delivery history. A processor may calculate a plurality of respective drug delivery amounts implemented using different advisory mode algorithms. A respective advisory drug delivery amount of the plurality of respective advisory drug delivery amounts may be selected by the processor. A recommendation may be generated based on the selected respective advisory drug delivery amount.
A61M 5/172 - Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters electrical or electronic
G16H 10/60 - ICT specially adapted for the handling or processing of patient-related medical or healthcare data for patient-specific data, e.g. for electronic patient records
G16H 20/17 - ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients delivered via infusion or injection
33.
TECHNIQUES TO DETERMINE PATTERNS IN BLOOD GLUCOSE MEASUREMENT DATA AND A USER INTERFACE FOR PRESENTATION THEREOF
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 warehouse 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 10/60 - ICT specially adapted for the handling or processing of patient-related medical or healthcare data for patient-specific data, e.g. for electronic patient records
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
34.
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.
The exemplary embodiments may dynamically adjust an Insulin on Board (JOB) 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 JOB.
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
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
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
36.
INSTRUMENT FOR A MEDICAMENT DELIVERY DEVICE THAT ACTS AS NEEDLE AND CANNULA
Exemplary embodiments may provide a medicament delivery device that includes a single instrument for piercing the skin of the user and for acting as a conduit for delivering medicament to the user subcutaneously. The exemplary embodiments may reduce discomfort caused by a rigid cannula or needle. The exemplary embodiments may provide instruments that are configured to be comfortable to the user when the instruments are in place beneath the skin of the user, such as when a medicament delivery device is delivering medicament to the user.
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.
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 1/047 - 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
F04B 9/06 - Piston machines or pumps characterised by the driving or driven means to or from their working members the means being mechanical the means including spring- or weight-loaded lost-motion devices
F04B 19/22 - Other positive-displacement pumps of reciprocating-piston type
F04B 23/02 - Pumping installations or systems having reservoirs
39.
ADAPTATION OF A MEDICAMENT DELIVERY DEVICE TO CHANGING ENVIRONMENTAL CONDITIONS
The exemplary embodiments may detect the changed ambient air pressure and may adjust settings for the medicament delivery device to compensate for the changed ambient air pressure. The exemplary embodiments may detect the changed ambient air pressure and may adjust settings for the medicament delivery device to compensate for the changed ambient air pressure. Based on the detection of these events, the medicament delivery device may be switched into a flight mode. In the flight mode, medicament boluses may be reduced to nominal dosages, basal delivery rates may be modified and sample periods for sensors, like glucose monitors, may be shortened to sample sensor values more frequently. The exemplary embodiments may prohibit delivery of medicament during times of changing ambient air pressure to avoid over-delivering or under-delivering the medicament due to the ambient air pressure level.
Disclosed are a system, techniques and processes for monitoring and modifying a drug treatment regimen when a user partakes in a ketogenic diet. The disclosed system obtains ketone level measurements of a user and indicates a user's adherence to the ketogenic diet as well as modifying a user's total daily dosage of a drug based on the user's following the ketogenic diet.
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 20/10 - 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
42.
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.
The exemplary embodiments may detect compression of a biological sensor and/or biological tissue of the user and may prompt or take corrective action to address the compression. A compression sensor may be provided to sense compression of the biological sensor and/or biological tissue of the user. Sensor data from the compression sensor may be processed to detect the compression. The detection of the compression may trigger corrective action. The corrective action may include an alert to alert the user to suggest a change in position or body orientation so as to alleviate the compression. The corrective action may include adjusting the biological sensor data to compensate for the compression or may include adjusting the quantity or rate of medicament delivered to a user to compensate for the compression. In some exemplary embodiments a data logger is provided to work with the biological sensor. The data logger may automatically log compression sensor data and biological sensor data.
Disclosed herein are various embodiments comprising methods to propose or modify a basal profile of a user, wherein the basal profile is delivered by an automatic drug delivery system operating in manual mode or is administered manually by the user. Suggestions of initial basal profiles or modifications to existing basal profiles may be based on previous glucose control outcomes or previous insulin delivery as recorded by the automatic drug delivery system.
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.
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
F16K 99/00 - Subject matter not provided for in other groups of this subclass
G05D 7/01 - Control of flow without auxiliary power
Disclosed are techniques, processes, systems, and programming code that enables users of automatic drug delivery devices to initiate the automatic drug delivery device for an initial use phase as well as implement changes that control the adjustment of target setpoints by a medication delivery algorithm used in the control of the automatic drug delivery device. During the initial use phase, the automatic drug delivery device may be based on the user's glucose control outcome without performing time consuming and frequent settings of sensor values as well as allowing users to remain substantially within range of any target setpoints. In addition, the disclosed techniques, processes, systems, and programming code enable users to have initial dosage settings automatically set without having to input what were previously considered fundamental inputs.
Some embodiments an infusion pump system can be configured to modify alarm limit parameters as the user's insulin load increases or decreases. Moreover, in particular embodiments, the infusion pump system can be configured to provide a “missed bolus” or “missed meal” alarm in response to the user's blood glucose characteristics, the user's insulin load information, 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 40/63 - ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for local operation
A61M 5/145 - Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. by means of pistons
48.
AUTOMATIC DRUG DELIVERY SYSTEM HAVING MULTIPLE COMMUNICATION OPTIONS
Disclosed herein is a drug delivery system wherein wearable components of the system are provided with Wi-Fi and/or cellular capabilities such as to allow different modalities for inter-component communications and, further, to allow access to a plethora of cloud-based services to enhance the functionality of the system.
The exemplary embodiments provide an automated approach for adjusting the medicament delivery rate to the user when operating in an open loop manner (“open mode”). The approach relies upon an insulin delivery history to the user make adjustments to the medicament delivery rate in the open mode. In particular, the exemplary embodiments may look at the medicament delivery history while the medicament delivery device is operating in a closed loop manner (“closed mode”) to determine how to adjust the open mode medicament delivery rate. It is presumed that in closed mode, the control system of the medicament device has gained knowledge over time about how to control the medicament delivery rate to produce good treatment outcomes for the user. The exemplary embodiments leverage this knowledge to adjust the open mode medicament delivery rates. Medicament bolus deliveries in open mode may also be adjusted in like fashion.
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
50.
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.
Disclosed are techniques to establish a modified pump rate that mitigates the effects of a pump occlusion and enables a recommended dosage of insulin to be output by a pump mechanism over the course of a control cycle. In an example, the pump rate may be reduced by adding a calculated time interval between application of actuation commands to extend the amount of time over which insulin may be output by the pump mechanism.
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
G05D 7/06 - Control of flow characterised by the use of electric means
G05B 15/02 - Systems controlled by a computer electric
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.
In one implementation, an insulin delivery system using an on-body network includes an insulin delivery device that is adapted to administer dosages of insulin to a patient; a controller that is adapted to control operation of the insulin delivery device, to establish a first network connection in which the controller acts in a central role, and to establish a second network connection in which the controller acts in a peripheral role; one or more peripheral devices that are adapted to generate patient data related to blood glucose levels and to transmit the patient data wirelessly over the first network connection, the peripheral devices acting in a peripheral role over the first network connection; and a mobile application installed on a mobile computing device that is programmed to communicate with the controller over the second network connection, the mobile application communicating in a central role over the second network connection.
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
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
Disclosed are techniques to establish initial settings for an automatic insulin delivery device. An adjusted total daily insulin (TDI) factor usable to calculate a TDI dosage may be determined. The adjusted TDI factor may be a TDI per unit of a physical characteristic of the user (e.g., weight) times a reduction factor. The adjusted TDI factor may be compared to a maximum algorithm delivery threshold. Based on the comparison result, the application or algorithm may set a TDI dosage and output a control signal. 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.
G08B 1/08 - Systems for signalling characterised solely by the form of transmission of the signal using electric transmission
A61M 5/172 - Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters electrical or electronic
G16H 10/40 - ICT specially adapted for the handling or processing of patient-related medical or healthcare data for data related to laboratory analysis, e.g. patient specimen analysis
G16H 10/60 - ICT specially adapted for the handling or processing of patient-related medical or healthcare data for patient-specific data, e.g. for electronic patient records
G16H 20/17 - ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients delivered via infusion or injection
G16H 40/60 - 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 40/67 - 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
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 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
Disclosed are processes and techniques for a correction factor determination process for determining a correction factor for delivering a drug to a patient via a drug delivery device. For example, for an insulin delivery device, the disclosed techniques enable adjustment of the patient’s correction factor in real time based on the deviation of the patient’s glucose concentrations against clinically recommended targets. For example, a method for determining a correction factor may include determining an insulin action (Iaction) for a patient over a duration, the insulin action representing a total insulin metabolized, determining glucose information for the patient over the duration, the glucose information representing glucose activity, and determining an estimated correction factor (CFest) based on (glucose information) / (insulin action) for the duration. Other embodiments are described.
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
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.
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.
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
58.
USER INTERFACE DISPLAYS FOR ASSISTING IN MEDICAMENT BOLUS CALCULATION
Exemplary embodiments may provide a user interface and logic for assisting a user in calculating a proper medicament bolus dosage. The user interface may be simple and easy to understand. The user interface may clearly specify needed inputs, such as a carbohydrates amount for a meal that is about to be ingested and the current glucose level reading for the user. Entered inputs may be displayed on the user interface. The user interface may depict key calculated values resulting from calculations that involve the inputs, including the total bolus dosage calculation. The user interface also may depict the values that contribute to the total bolus dosage calculation. Some of the input values, such as carbohydrates amount, may be prepopulated by the management device or medicament delivery device. The user interface may permit overriding of prepopulated input values.
Fluid delivery devices with passive or pressure-based control valves are described. For example, a fluid delivery device may include a fluid path, a pressure source fluidically coupled to a fluid source storing a fluid, and a pressure-based control valve arranged in the fluid path and configured to move in an opening direction in response to a fluid delivery pressure applied by the pressure source in an upstream portion of the fluid path against the pressure-based control valve, in which the pressure control valve is in an open configuration responsive to the fluid delivery pressure being equal to or greater than a cracking pressure. In some embodiments, the pressure-based control valve may be or may include a bourdon tube. Other embodiments are described.
Disclosed are a computing apparatus, a computer-readable medium and a method that enable a user to use subjective inputs to alter settings of a wearable automatic drug delivery system. A user input device is presented on a graphical user interface that enables input of a subjective insulin need parameter. In response to receiving the input, the processor may modify a subjective coefficient value. A specific factor useable by an automatic insulin delivery algorithm is set based on the subjective coefficient value. Physiological condition data related to the user and the set specific factor may be used to determine a dosage of insulin to be delivered to the user based on the collected physiological condition data of the user. The processor may cause the determined dosage of insulin to be delivered to the user based on an output of the automatic insulin delivery algorithm.
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 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
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
A medical device comprising an infusion device comprising a fluid reservoir to contain a therapeutic fluid and a transcutaneous access tool fluidly coupled to the fluid reservoir, the transcutaneous access tool configured to deliver the therapeutic fluid subcutaneously to a patient; wherein the infusion device operates in a stand-by mode prior to the therapeutic fluid being introduced into the fluid reservoir; wherein the infusion device operates to deploy the transcutaneous access tool within a predetermined deployment time period upon filling the fluid reservoir to a predetermined fill level with the therapeutic fluid.
Disclosed herein are various embodiments providing an expandable, flexible reservoir for use in a wearable drug delivery device. The reservoir comprises a flexible enclosure made with plastic film which incorporates pleats forming the side walls thereof to increase the volume efficiency and to avoid a “pillowing” effect when the reservoir is filled. The pleats may be formed at non-right angles with respect to each other such as to form a curved side walls for the reservoir. In variations of the invention, various methods are disclosed for maintaining a vacuum with the reservoir during its shelf life.
A61M 5/148 - Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. by means of pistons flexible
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
65.
Safety constraints for a control algorithm based drug delivery system
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.
The embodiments described herein may relate to methods and systems for adjusting insulin delivery. Some methods and systems may be configured to adjust insulin delivery to personalize automated insulin delivery for a person with diabetes. Such personalization may include adjusting user specific dosage parameters in response to one or more back-filled time segments associated with a diurnal time block.
A61M 5/172 - Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters electrical or electronic
G16H 20/17 - ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients delivered via infusion or injection
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration, pH-value
A61B 5/00 - Measuring for diagnostic purposes ; Identification of persons
A61M 5/315 - Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod; Appliances on the rod for facilitating dosing
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
A drug delivery device 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.
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.
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 20/17 - 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 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 20/60 - 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 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
71.
METHODS AND SYSTEMS FOR STERILIZING SEALED COMPONENTS OF A DRUG DELIVERY DEVICE
Fluid delivery devices with sterilization management systems are described. For example, a fluid delivery device may include a device region fluidically coupled to a fluid path, the fluid path having at least one opening to allow a sterilization source to flow into the device region, an exposure valve arranged in the fluid path and configured to seal or unseal the at least one opening, the exposure valve comprising a piston having a sealing component arranged at a first end facing the at least one opening, a biasing element configured to contact a second end of the piston, arranged opposite the first end, to bias the piston toward the at least one opening, an activation element configured to be activated by a stimulus to move the piston to a sterilization position during a sterilization process and deactivated responsive to removal of the stimulus to cause the piston to be moved into a sealing position, the at least one opening is unsealed when the piston is in the sterilization position to allow a sterilization source to sterilize the device region via the fluid path. Other embodiments are described.
A system is provided with an insulin delivery device configured to deliver insulin to a user of the system and a computer-based control unit associated with the insulin delivery device. The computer-based control unit includes a user interface and a computer-based processor. The computer-based processor is configured to calculate a relative insulin on board value for a specific time by calculating a first value that represents a reference insulin on board value at the specific time, calculating a second value that represents an automated insulin on board value at the specific time, and subtracting one of the first and second values from the other. The automated insulin on board value represents at least one insulin delivery automatically specified by the computer-based control unit. Methods of use are also disclosed.
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 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 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
G16Z 99/00 - Subject matter not provided for in other main groups of this subclass
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.
F16H 21/50 - Gearings comprising primarily only links or levers, with or without slides with movements in three dimensions for interconverting rotary motion and reciprocating motion
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
Disclosed herein are structures for ensuring that the reservoir of drug delivery device is free from any residual air before the device is filled with a liquid drug and put into use. The structures described herein are designed to prevent air from entering the reservoir during the pendency of a shelf life of the drug delivery device and/or to remove any residual air that has entered the reservoir of the drug delivery device prior to it being filled with the liquid drug.
A novel embodiment of a pump mechanism, 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 coiled flexible linkage connected to a drive mechanism, such that a force imparted by the drive mechanism causes the coiled flexible linkage to uncoil, causing a linear translation of the plunger through the reservoir to force a liquid drug contained within the reservoir through a fluid port to a patient.
Methods of insulin delivery may include Selecting a basal insulin delivery rate responsive to a projected blood glucose level that approximates a target blood glucose level. Methods of insulin delivery may further include generating insulin delivery instructions for an insulin delivery device, the insulin delivery instructions corresponding to the basal insulin delivery rate and for a variable time duration relative to an intended time duration.
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
77.
DUAL NEEDLE VALVE FOR A WEARABLE DRUG DELIVERY DEVICE
Disclosed is a valve for use in a pump for a wearable drug delivery device for moving a liquid drug from reservoir into a pump chamber and thereafter from the pump chamber to a patient interface. The valve can comprise two needles, a first needle in fluid communication with the reservoir and a second needle in fluid communication with the patient interface. The first and second needles may be linearly translated to either cover the lumen opening of a needle with a septum or place the lumen opening of the needle in fluid communication with the pump chamber. When the first needle is in fluid communication with the pump chamber, the liquid drug may be transferred from the reservoir to the pump chamber via suction created by a plunger in the pump chamber. When the second needle is in fluid communication with the pump chamber, the liquid drug may be transferred from the pump chamber to the patient interface via a pressure created by the plunger in the pump chamber.
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.
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.
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.
The exemplary embodiments may account for a change in potency of a medicament and adjust the dosage of medicament delivered to a user via a medicament delivery device to compensate for the change in potency. The medicament delivery device may determine the amount of change in the potency in the medicament and may make the adjustment in dosage of the medicament delivered to the user automatically without user input. The net result in that the dosage of medicament delivered to the user is better matched to the user's true need for the medicament.
Disclosed are processes and techniques for a drug delivery system to maintain optimal drug delivery for a patient according to a treatment plan. The disclosed techniques enable a drug delivery system to delivery adjusted drug dosages and/or drug delivery cost function aggressiveness factors modified based on clusters or patterns of patient drug dosages and/or response event probabilities. For example, a controller for operating a drug delivery device may operate to determine a plurality of dosage clusters for a patient based on drug dosage patient information, determine an adjustment profile for each of the dosage clusters, determine a current cluster for a dosage cycle, determine an adjusted dosage for the dosage cycle by applying the adjustment profile to a default dosage, and provide a signal to the drug delivery device to deliver the adjusted dosage to the patient for the dosage cycle. Other embodiments are described.
The insulin to carbohydrate ratio (ICR) and the correction factor for a user of a medicament delivery device may be automatically adjusted. The automatic adjustments may tailor the values to the user's actual insulin needs. Various factors may be examined to determine how to adjust the ICR and the correction factor. The identified factors are weighed with the processor to decide whether to increase or decrease the insulin to carbohydrate ratio or the correction factor. The insulin to carbohydrate ratio or the correction factor for the user are adjusted based on the weights of the identified factors. In addition or in the alternative, automatic adjustments of user-requested insulin boluses may be made to requested dosages and timing of deliveries of the insulin boluses. In some instances, the exemplary embodiments may deliver a percentage of the insulin bolus dosage initially and deliver the remaining percentage after a delay to reduce the risk of hypoglycemia for the user.
A61M 5/172 - Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters electrical or electronic
G16H 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 20/13 - 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
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration, pH-value
84.
METHODS AND SYSTEMS FOR MANAGING FLUID PUMP DELIVERY IMPEDIMENTS
Fluid delivery devices with occlusion management are described. For example, a fluid delivery system may include at least one force element, at least one moveable element configured to be moved in a dispensing direction by the at least one force element during a pump cycle to expel a fluid from the fluid delivery system, and an occlusion management system comprising at least one emergency element operably coupled to the at least one moveable element, the occlusion management system comprising logic operative to activate the at least one emergency element responsive to a determination of an occlusion to provide additional force to move the at least one moveable element in the dispensing direction. Other embodiments are described.
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.
A method of adjusting insulin therapy settings for a person with diabetes that treats the diabetes by administering first and second types of insulin includes: storing, in a non-transitory storage medium of an electronic device, a first-type insulin dosage suggestion for a person with diabetes regarding a first type of insulin having an active time that is longer than an active time for a second type of insulin; receiving blood glucose data for the person with diabetes, the blood glucose data including blood glucose values for a plurality of days; determining a first variability of the blood glucose values for a selected first period of time during the plurality of days; and modifying the first-type insulin dosage suggestion in the non-transitory storage medium based on the determined first variability.
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
88.
ADAPTATION OF MEDICAMENT DELIVERY IN RESPONSE TO USER STRESS LOAD
Disclosed are an automatic medication delivery system includes a stress detection and response algorithm or application that may operate in cooperation with a medication delivery algorithm or application. Execution of the instructions of the stress detection and response application causes a processor to obtain a respective measurement value related to a physiological condition of a user from one or more sensors. The obtained respective measurement values are evaluated against a respective threshold measurement value. The processor determines, based on the evaluation of the obtained respective measurement values, a degree of stress the user is experiencing. In response to the determination of the degree of stress the user is experiencing, the processor may modify an imminent dosage of a liquid drug to be delivered, a time of delivery of the imminent dosage, or both. A dosage of the liquid drug may be expelled based on the modifying.
The disclosed embodiments are directed to secondary methods of communicating with a drug delivery device when the primary method is unavailable. Secondary methods include the use of a pattern of taps on the housing of the drug delivery device to convey authentication information and commands to the drug delivery device. Feedback confirming the interpretation of the pattern of taps may be provided to the user via a vibration, sound, or blinking lights.
Disclosed herein is a reservoir for use in a wearable drug delivery device having multiple chambers of potentially varying lengths or arrangement so as to efficiently utilize available space within a housing of the drug delivery device. Each of the chambers is connected to a fluid path and a liquid drug is drawn from each of the chambers by suction applied to the fluid path. Each of the chambers is fitted with a free piston which is moved within the chamber by the suction applied to the fluid path as it draws the liquid drug out of the chamber, thereby eliminating the need for a mechanical arrangement for moving the piston within each of the chambers.
The disclosed embodiments are directed to methods for dynamically adjusting the total daily insulin requirements of a user during pregnancy, based on the gestational week. An initial estimate of the adjusted total daily insulin requirement may be calculated as a multiple of the pre-pregnancy total daily insulin requirement, based on an average scale factor from a population of pregnant women suffering from Type I diabetes mellitus. An automatic drug delivery device may adjust the initial estimate of the total daily insulin requirement based on blood glucose level readings from a continuous glucose monitor during the course of the pregnancy.
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
92.
TECHNIQUES FOR RECOMMENDING RESCUE CARBOHYDRATE INGESTION IN AUTOMATIC MEDICATION DELIVERY SYSTEMS
Provided are techniques, devices and systems that include monitoring a trend of blood glucose measurement values over a series of measurement cycles. A processor may identify a potential excursion outside a range of a target blood glucose measurement value setting of a user based on the monitored trend. In response to the identified potential excursion, an alert may be generated to the user to consume rescue carbohydrates. In addition, the disclosed techniques may include a processor that assesses the factors related to a potential impending hypoglycemic event for a user. Based on a result of the assessment of the factors, the processor may determine whether the user is approaching the potential impending hypoglycemic event for the user. In response to a determination that the user is approaching the potential impending hypoglycemic event for the user, a number of rescue carbohydrates to suggest for consumption by the user may be determined.
The embodiments described herein may relate to methods and systems for adjusting insulin delivery. Some methods and systems may be configured to adjust insulin delivery to personalize automated insulin delivery for a person with diabetes. Some methods and systems may be configured to adjust insulin delivery to a person with diabetes according to one or more conditions of an insulin delivery device. Some methods and systems may be configured to enable a lock-out mode where adjustment to insulin delivery to personalize automated insulin delivery is restricted.
A61M 5/172 - Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters electrical or electronic
G16H 20/17 - ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients delivered via infusion or injection
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration, pH-value
A61B 5/00 - Measuring for diagnostic purposes ; Identification of persons
A61M 5/315 - Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod; Appliances on the rod for facilitating dosing
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
94.
TRANSITIONS TO REPLACEMENT ON-BODY MEDICAL DEVICES FROM EXPIRING ON-BODY MEDICAL DEVICES THAT AVOID DOWNTIME
The switchover between an expiring on-body medicament delivery device and a replacement on-body medicament is made to eliminate or significantly decrease the time where an on-body medicament delivery device is operational to deliver medicament to a user. The replacement on-body medicament device is attached to the user and prepped for operation while the expiring on-body medicament delivery device is still operational. The switchover between on-body sensors also may be improved. Methods for calibrating a replacement on-body sensor while the expiring on-body sensor is still operative are provided. The calibrating may be performed quickly so that there is no gap in operation between expiration of the expiring on-body sensor and full operation of the replacement on-body sensor.
Exemplary embodiments account for differing needs of a user over the menstrual cycle of the user to better control the blood glucose concentration of the user. The exemplary embodiments may be realized in control systems for medicament delivery devices that deliver medicaments, such as medicaments that regulate blood glucose concentration levels. Examples of such medicaments that regulate blood glucose concentration levels include insulin, glucagon, and glucagon peptide-1 (GLP-1) agonists. The exemplary embodiments are able to better tailor the dosages of the medicament delivered to the user with the medicament delivery device to reduce the risk of hyperglycemia and hypoglycemia and help reduce blood glucose concentration excursions.
A61M 5/172 - Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters electrical or electronic
G16H 20/17 - ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients delivered via infusion or injection
G16H 40/67 - ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for remote operation
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.
The disclosed embodiments are directed to methods for adjusting, on a per individual basis, the maximum delivery limit of insulin delivered to a diabetic person via an automatic insulin delivery system, particularly for a diabetic who receives basal or bolus doses of insulin via an automatic insulin delivery system. Various embodiments of the method disclosed herein may be incorporated into a dosing algorithm of an automatic insulin delivery system.
Described are techniques, processes, devices, computer-readable media that enable provision of an indication of whether it is safe for a person with diabetes to participate in exercise while using a wearable drug delivery system. A processor may receive or obtain physiological data related to a condition of a wearer of the wearable drug delivery system and by evaluating an exercise model that uses inputs related to the physiological data to make the determination of whether it is safe to exercise and output an exercise safety signal. Modifications to the wearer's medication treatment plan and other actions may be based on an outputted exercise safety signal.
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
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
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.
G01D 5/20 - 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 inductance, e.g. by a movable armature
F04B 51/00 - Testing machines, pumps, or pumping installations
100.
USER PARAMETER DEPENDENT COST FUNCTION FOR PERSONALIZED REDUCTION OF HYPOGLYCEMIA AND/OR HYPERGLYCEMIA IN A CLOSED LOOP ARTIFICIAL PANCREAS 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 user's 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.
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
patents
