Patent Description:
Infusion pump devices and systems are relatively well known in the medical arts, for use in delivering or dispensing an agent, such as insulin or another prescribed medication, to a patient. typical infusion pump includes a pump drive system which typically includes a small motor and drive train components that convert rotational motor motion to a translational displacement of a plunger (or stopper) in a reservoir that delivers medication from the reservoir to the body of a user via a fluid path created between the reservoir and the body of a user. Use of infusion pump therapy has been increasing, especially for delivering insulin for diabetics.

Continuous insulin infusion provides greater control of a diabetic's condition, and hence, control schemes are being developed that allow insulin infusion pumps to monitor and regulate a user's blood glucose level in a substantially continuous and autonomous manner. Regulating blood glucose level is complicated by variations in the response time for the type of insulin being used along with variations in a user's individual insulin response and daily activities (e.g., exercise, carbohydrate consumption, bolus administration, and the like). To compensate for these variations, the amount of insulin being infused in an automated manner may also vary. Reliance solely on currently sensed glucose values may result in delivery adjustments that are too late to avoid a hypoglycemic or hyperglycemic event, so accordingly, predictive algorithms may be utilized to provide estimations of the future blood glucose levels as an aid in regulating the blood glucose level.

<CIT> discloses an autonomously operating device configured to deliver insulin based on a sensor glucose value. The device is also configured to inform the user of an alert condition.

One scenario that can be problematic occurs when a user consumes fast-acting carbohydrates, for example, to avoid a potential hypoglycemic event. This, in turn, can result in a spike in the user's blood glucose level, which, in tum, can result in a rising trend in glucose values indicating a need to deliver insulin to mitigate the rise in blood glucose level, thereby unintentionally counteracting the fast-acting carbohydrates. While a quick response time is desired to facilitate a stable blood glucose level, automatically recovering from responding too quickly may not be feasible since infusion devices are generally incapable of undoing a previous delivery. Thus, there is a need to distinguish actionable events that the infusion device should respond to from those that do not require an immediate response.

The object of the present invention is solved by the subject-matter of the independent claims, wherein further embodiments are incorporated in the dependent claims.

Infusion systems, infusion devices, and related operating methods are provided. An embodiment of a method of operating an infusion device to deliver fluid capable of influencing a physiological condition to a body of a user is provided. The method involves autonomously operating the infusion device to deliver the fluid based at least in part on measurement values for the physiological condition in the body of the user, detecting a nonactionable condition, such as a rescue condition, based on one or more of the measurement values, and in response to detecting the nonactionable condition, limiting delivery of the fluid while autonomously operating the infusion device.

An embodiment of an infusion system is also provided. The infusion system comprises a sensing arrangement to obtain measurement values for a physiological condition from a body of a user and an infusion device including an actuation arrangement operable to deliver fluid to the body of the user and a control system coupled to the actuation arrangement. The fluid influences the physiological condition of the user, and the control system is configured to autonomously operate the actuation arrangement to deliver a variable rate of infusion based on the measurement values, detect a rescue condition based on one or more of the measurement values, and temporarily limit the variable rate of infusion in response to the rescue condition.

An apparatus of an infusion device is also provided. The infusion device comprises an actuation arrangement operable to deliver fluid to a body of a user, a data storage element to maintain control parameters for a closed-loop operating mode, a communications interface to receive measurement values indicative of a physiological condition in the body of the user influenced by the fluid, and a control module coupled to the actuation arrangement, the data storage element, and the communications interface. The control module is configured to autonomously operate the actuation arrangement to deliver a variable rate of infusion based on the measurement values and the control parameters in accordance with the closed-loop operating mode, detect a rescue condition based on one or more of the measurement values, and temporarily limit the variable rate of infusion in response to the rescue condition.

A more complete understanding of the subject matter may be derived by referring to the detailed description and claims when considered in conjunction with the following figures, wherein like reference numbers refer to similar elements throughout the figures, which may be illustrated for simplicity and clarity and are not necessarily drawn to scale.

While the subject matter described herein can be implemented in any electronic device that includes a motor, exemplary embodiments described below are implemented in the form of medical devices, such as portable electronic medical devices. Although many different applications are possible, the following description focuses on a fluid infusion device (or infusion pump) as part of an infusion system deployment. For the sake of brevity, conventional techniques related to infusion system operation, insulin pump and/or infusion set operation, and other functional aspects of the systems (and the individual operating components of the systems) may not be described in detail here. Examples of infusion pumps may be of the type described in, but not limited to, <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; and <CIT>;.

Embodiments of the subject matter described herein generally relate to fluid infusion devices including a motor that is operable to linearly displace a plunger (or stopper) of a reservoir provided within the fluid infusion device to deliver a dosage of fluid, such as insulin, to the body of a user. Dosage commands that govern operation of the motor may be generated in an automated manner in accordance with the delivery control scheme associated with a particular operating mode, and the dosage commands may be generated in a manner that is influenced by a current (or most recent) measurement of a physiological condition in the body of the user. For example, in a closed-loop operating mode, dosage commands may be generated based on a difference between a current (or most recent) measurement of the interstitial fluid glucose level in the body of the user and a target (or reference) glucose value. In this regard, the rate of infusion may vary as the difference between a current measurement value and the target measurement value fluctuates. For purposes of explanation, the subject matter is described herein in the context of the infused fluid being insulin for regulating a glucose level of a user (or patient); however, it should be appreciated that many other fluids may be administered through infusion, and the subject matter described herein is not necessarily limited to use with insulin.

As described in greater detail below, primarily in the context of <FIG>, in exemplary embodiments described herein, a nonactionable condition is detected based on the measurement values for a physiological condition in the body of the user while autonomously operating the infusion device, and in response to detecting the nonactionable condition, the autonomous delivery of the fluid influencing the physiological condition is limited, restricted, or otherwise constrained temporarily, thereby mitigating any potential response to the nonactionable condition. For purposes of explanation, the subject matter is described herein in the context of the nonactionable condition as being a rescue condition where the user has consumed, ingested, or otherwise administered carbohydrates configured to increase his or her blood glucose level and mitigate a potential hypoglycemic event (e.g., fast-acting or "rescue" carbohydrates). In this regard, the rescue condition is detected based on a characteristic of the user's glucose measurement values, such as, for example, a rate of change in the glucose measurement values over successive samples, which occurs at the same time as or after the user's glucose measurement values indicate the potential for a rescue condition exists (e.g., when the user's predicted and/or measured glucose values are low or otherwise indicate a potential hypoglycemic event exists). In essence, a characteristic signature for a rescue condition is detected or otherwise identified from the glucose measurement values. Thereafter, the rate of insulin infusion may be capped or otherwise reduced to limit any potential response to the rescue condition, so that any consumed rescue carbohydrates can achieve their intended effect of avoiding a hypoglycemic condition without undue interference by the autonomous control scheme.

Turning now to <FIG>, one exemplary embodiment of an infusion system <NUM> includes, without limitation, a fluid infusion device (or infusion pump) <NUM>, a sensing arrangement <NUM>, a command control device (CCD) <NUM>, and a computer <NUM>. The components of an infusion system <NUM> may be realized using different platforms, designs, and configurations, and the embodiment shown in <FIG> is not exhaustive or limiting. In practice, the infusion device <NUM> and the sensing arrangement <NUM> are secured at desired locations on the body of a user (or patient), as illustrated in <FIG>. In this regard, the locations at which the infusion device <NUM> and the sensing arrangement <NUM> are secured to the body of the user in <FIG> are provided only as a representative, non-limiting, example. The elements of the infusion system <NUM> may be similar to those described in <CIT>,.

In the illustrated embodiment of <FIG>, the infusion device <NUM> is designed as a portable medical device suitable for infusing a fluid, a liquid, a gel, or other agent into the body of a user. In exemplary embodiments, the infused fluid is insulin, although many other fluids may be administered through infusion such as, but not limited to, HIV drugs, drugs to treat pulmonary hypertension, iron chelation drugs, pain medications, anti-cancer treatments, medications, vitamins, hormones, or the like. In some embodiments, the fluid may include a nutritional supplement, a dye, a tracing medium, a saline medium, a hydration medium, or the like.

The sensing arrangement <NUM> generally represents the components of the infusion system <NUM> configured to sense, detect, measure or otherwise quantify a condition of the user, and may include a sensor, a monitor, or the like, for providing data indicative of the condition that is sensed, detected, measured or otherwise monitored by the sensing arrangement. In this regard, the sensing arrangement <NUM> may include electronics and enzymes reactive to a biological or physiological condition of the user, such as a blood glucose level, or the like, and provide data indicative of the blood glucose level to the infusion device <NUM>, the CCD <NUM> and/or the computer <NUM>. For example, the infusion device <NUM>, the CCD <NUM> and/or the computer <NUM> may include a display for presenting information or data to the user based on the sensor data received from the sensing arrangement <NUM>, such as, for example, a current glucose level of the user, a graph or chart of the user's glucose level versus time, device status indicators, alert messages, or the like. In other embodiments, the infusion device <NUM>, the CCD <NUM> and/or the computer <NUM> may include electronics and software that are configured to analyze sensor data and operate the infusion device <NUM> to deliver fluid to the body of the user based on the sensor data and/or preprogrammed delivery routines. Thus, in exemplary embodiments, one or more of the infusion device <NUM>, the sensing arrangement <NUM>, the CCD <NUM>, and/or the computer <NUM> includes a transmitter, a receiver, and/or other transceiver electronics that allow for communication with other components of the infusion system <NUM>, so that the sensing arrangement <NUM> may transmit sensor data or monitor data to one or more of the infusion device <NUM>, the CCD <NUM> and/or the computer <NUM>.

Still referring to <FIG>, in various embodiments, the sensing arrangement <NUM> may be secured to the body of the user or embedded in the body of the user at a location that is remote from the location at which the infusion device <NUM> is secured to the body of the user. In various other embodiments, the sensing arrangement <NUM> may be incorporated within the infusion device <NUM>. In other embodiments, the sensing arrangement <NUM> may be separate and apart from the infusion device <NUM>, and may be, for example, part of the CCD <NUM>. In such embodiments, the sensing arrangement <NUM> may be configured to receive a biological sample, analyte, or the like, to measure a condition of the user.

In various embodiments, the CCD <NUM> and/or the computer <NUM> may include electronics and other components configured to perform processing, delivery routine storage, and to control the infusion device <NUM> in a manner that is influenced by sensor data measured by and/or received from the sensing arrangement <NUM>. By including control functions in the CCD <NUM> and/or the computer <NUM>, the infusion device <NUM> may be made with more simplified electronics. However, in other embodiments, the infusion device <NUM> may include all control functions, and may operate without the CCD <NUM> and/or the computer <NUM>. In various embodiments, the CCD <NUM> may be a portable electronic device. In addition, in various embodiments, the infusion device <NUM> and/or the sensing arrangement <NUM> may be configured to transmit data to the CCD <NUM> and/or the computer <NUM> for display or processing of the data by the CCD <NUM> and/or the computer <NUM>.

In some embodiments, the CCD <NUM> and/or the computer <NUM> may provide information to the user that facilitates the user's subsequent use of the infusion device <NUM>. For example, the CCD <NUM> may provide information to the user to allow the user to determine the rate or dose of medication to be administered into the user's body. In other embodiments, the CCD <NUM> may provide information to the infusion device <NUM> to autonomously control the rate or dose of medication administered into the body of the user. In some embodiments, the sensing arrangement <NUM> may be integrated into the CCD <NUM>. Such embodiments may allow the user to monitor a condition by providing, for example, a sample of his or her blood to the sensing arrangement <NUM> to assess his or her condition. In some embodiments, the sensing arrangement <NUM> and the CCD <NUM> may be used for determining glucose levels in the blood and/or body fluids of the user without the use of, or necessity of, a wire or cable connection between the infusion device <NUM> and the sensing arrangement <NUM> and/or the CCD <NUM>.

In one or more exemplary embodiments, the sensing arrangement <NUM> and/or the infusion device <NUM> are cooperatively configured to utilize a closed-loop system for delivering fluid to the user. Examples of sensing devices and/or infusion pumps utilizing closed-loop systems may be found at, but are not limited to, the following <CIT><CIT><CIT><CIT><CIT><CIT> and <CIT>, all of which are incorporated herein by reference in their entirety. In such embodiments, the sensing arrangement <NUM> is configured to sense or measure a condition of the user, such as, blood glucose level or the like. The infusion device <NUM> is configured to deliver fluid in response to the condition sensed by the sensing arrangement <NUM>. In tum, the sensing arrangement <NUM> continues to sense or otherwise quantify a current condition of the user, thereby allowing the infusion device <NUM> to deliver fluid continuously in response to the condition currently (or most recently) sensed by the sensing arrangement <NUM> indefinitely. In some embodiments, the sensing arrangement <NUM> and/or the infusion device <NUM> may be configured to utilize the closed-loop system only for a portion of the day, for example only when the user is asleep or awake.

<FIG> depict one exemplary embodiment of a fluid infusion device <NUM> (or alternatively, infusion pump) suitable for use in an infusion system, such as, for example, as infusion device <NUM> in the infusion system <NUM> of <FIG>. The fluid infusion device <NUM> is a portable medical device designed to be carried or worn by a patient (or user), and the fluid infusion device <NUM> may leverage any number of conventional features, components, elements, and characteristics of existing fluid infusion devices, such as, for example, some of the features, components, elements, and/or characteristics described in <CIT> and <CIT>. It should be appreciated that <FIG> depict some aspects of the infusion device <NUM> in a simplified manner; in practice, the infusion device <NUM> could include additional elements, features, or components that are not shown or described in detail herein.

As best illustrated in <FIG>, the illustrated embodiment of the fluid infusion device <NUM> includes a housing <NUM> adapted to receive a fluid-containing reservoir <NUM>. An opening <NUM> in the housing <NUM> accommodates a fitting <NUM> (or cap) for the reservoir <NUM>, with the fitting <NUM> being configured to mate or otherwise interface with tubing <NUM> of an infusion set <NUM> that provides a fluid path to/from the body of the user. In this manner, fluid communication from the interior of the reservoir <NUM> to the user is established via the tubing <NUM>. The illustrated fluid infusion device <NUM> includes a human-machine interface (HMI) <NUM> (or user interface) that includes elements <NUM>, <NUM> that can be manipulated by the user to administer a bolus of fluid (e.g., insulin), to change therapy settings, to change user preferences, to select display features, and the like. The infusion device also includes a display element <NUM>, such as a liquid crystal display (LCD) or another suitable display element, that can be used to present various types of information or data to the user, such as, without limitation: the current glucose level of the patient; the time; a graph or chart of the patient's glucose level versus time; device status indicators; etc..

The housing <NUM> is formed from a substantially rigid material having a hollow interior <NUM> adapted to allow an electronics assembly <NUM>, a sliding member (or slide) <NUM>, a drive system <NUM>, a sensor assembly <NUM>, and a drive system capping member <NUM> to be disposed therein in addition to the reservoir <NUM>, with the contents of the housing <NUM> being enclosed by a housing capping member <NUM>. The opening <NUM>, the slide <NUM>, and the drive system <NUM> are coaxially aligned in an axial direction (indicated by arrow <NUM>), whereby the drive system <NUM> facilitates linear displacement of the slide <NUM> in the axial direction <NUM> to dispense fluid from the reservoir <NUM> (after the reservoir <NUM> has been inserted into opening <NUM>), with the sensor assembly <NUM> being configured to measure axial forces (e.g., forces aligned with the axial direction <NUM>) exerted on the sensor assembly <NUM> responsive to operating the drive system <NUM> to displace the slide <NUM>. In various embodiments, the sensor assembly <NUM> may be utilized to detect one or more of the following: an occlusion in a fluid path that slows, prevents, or otherwise degrades fluid delivery from the reservoir <NUM> to a user's body; when the reservoir <NUM> is empty; when the slide <NUM> is properly seated with the reservoir <NUM>; when a fluid dose has been delivered; when the infusion pump <NUM> is subjected to shock or vibration; when the infusion pump <NUM> requires maintenance.

Depending on the embodiment, the fluid-containing reservoir <NUM> may be realized as a syringe, a vial, a cartridge, a bag, or the like. In certain embodiments, the infused fluid is insulin, although many other fluids may be administered through infusion such as, but not limited to, HIV drugs, drugs to treat pulmonary hypertension, iron chelation drugs, pain medications, anti-cancer treatments, medications, vitamins, hormones, or the like. As best illustrated in <FIG>, the reservoir <NUM> typically includes a reservoir barrel <NUM> that contains the fluid and is concentrically and/or coaxially aligned with the slide <NUM> (e.g., in the axial direction <NUM>) when the reservoir <NUM> is inserted into the infusion pump <NUM>. The end of the reservoir <NUM> proximate the opening <NUM> may include or otherwise mate with the fitting <NUM>, which secures the reservoir <NUM> in the housing <NUM> and prevents displacement of the reservoir <NUM> in the axial direction <NUM> with respect to the housing <NUM> after the reservoir <NUM> is inserted into the housing <NUM>. As described above, the fitting <NUM> extends from (or through) the opening <NUM> of the housing <NUM> and mates with tubing <NUM> to establish fluid communication from the interior of the reservoir <NUM> (e.g., reservoir barrel <NUM>) to the user via the tubing <NUM> and infusion set <NUM>. The opposing end of the reservoir <NUM> proximate the slide <NUM> includes a plunger <NUM> (or stopper) positioned to push fluid from inside the barrel <NUM> of the reservoir <NUM> along a fluid path through tubing <NUM> to a user. The slide <NUM> is configured to mechanically couple or otherwise engage with the plunger <NUM>, thereby becoming seated with the plunger <NUM> and/or reservoir <NUM>. Fluid is forced from the reservoir <NUM> via tubing <NUM> as the drive system <NUM> is operated to displace the slide <NUM> in the axial direction <NUM> toward the opening <NUM> in the housing <NUM>.

In the illustrated embodiment of <FIG>, the drive system <NUM> includes a motor assembly <NUM> and a drive screw <NUM>. The motor assembly <NUM> includes a motor that is coupled to drive train components of the drive system <NUM> that are configured to convert rotational motor motion to a translational displacement of the slide <NUM> in the axial direction <NUM>, and thereby engaging and displacing the plunger <NUM> of the reservoir <NUM> in the axial direction <NUM>. In some embodiments, the motor assembly <NUM> may also be powered to translate the slide <NUM> in the opposing direction (e.g., the direction opposite direction <NUM>) to retract and/or detach from the reservoir <NUM> to allow the reservoir <NUM> to be replaced. In exemplary embodiments, the motor assembly <NUM> includes a brushless DC (BLDC) motor having one or more permanent magnets mounted, affixed, or otherwise disposed on its rotor. However, the subject matter described herein is not necessarily limited to use with BLDC motors, and in alternative embodiments, the motor may be realized as a solenoid motor, an AC motor, a stepper motor, a piezoelectric caterpillar drive, a shape memory actuator drive, an electrochemical gas cell, a thermally driven gas cell, a bimetallic actuator, or the like. The drive train components may comprise one or more lead screws, cams, ratchets, jacks, pulleys, pawls, clamps, gears, nuts, slides, bearings, levers, beams, stoppers, plungers, sliders, brackets, guides, bearings, supports, bellows, caps, diaphragms, bags, heaters, or the like. In this regard, although the illustrated embodiment of the infusion pump utilizes a coaxially aligned drive train, the motor could be arranged in an offset or otherwise non-coaxial manner, relative to the longitudinal axis of the reservoir <NUM>.

As best shown in <FIG>, the drive screw <NUM> mates with threads <NUM> internal to the slide <NUM>. When the motor assembly <NUM> is powered and operated, the drive screw <NUM> rotates, and the slide <NUM> is forced to translate in the axial direction <NUM>. In an exemplary embodiment, the infusion pump <NUM> includes a sleeve <NUM> to prevent the slide <NUM> from rotating when the drive screw <NUM> of the drive system <NUM> rotates. Thus, rotation of the drive screw <NUM> causes the slide <NUM> to extend or retract relative to the drive motor assembly <NUM>. When the fluid infusion device is assembled and operational, the slide <NUM> contacts the plunger <NUM> to engage the reservoir <NUM> and control delivery of fluid from the infusion pump <NUM>. In an exemplary embodiment, the shoulder portion <NUM> of the slide <NUM> contacts or otherwise engages the plunger <NUM> to displace the plunger <NUM> in the axial direction <NUM>. In alternative embodiments, the slide <NUM> may include a threaded tip <NUM> capable of being detachably engaged with internal threads <NUM> on the plunger <NUM> of the reservoir <NUM>, as described in detail in <CIT> and <CIT>,.

As illustrated in <FIG>, the electronics assembly <NUM> includes control electronics <NUM> coupled to the display element <NUM>, with the housing <NUM> including a transparent window portion <NUM> that is aligned with the display element <NUM> to allow the display <NUM> to be viewed by the user when the electronics assembly <NUM> is disposed within the interior <NUM> of the housing <NUM>. The control electronics <NUM> generally represent the hardware, firmware, processing logic and/or software (or combinations thereof) configured to control operation of the motor assembly <NUM> and/or drive system <NUM>, as described in greater detail below in the context of <FIG>. Whether such functionality is implemented as hardware, firmware, a state machine, or software depends upon the particular application and design constraints imposed on the embodiment. Those familiar with the concepts described here may implement such functionality in a suitable manner for each particular application, but such implementation decisions should not be interpreted as being restrictive or limiting. In an exemplary embodiment, the control electronics <NUM> includes one or more programmable controllers that may be programmed to control operation of the infusion pump <NUM>.

The motor assembly <NUM> includes one or more electrical leads <NUM> adapted to be electrically coupled to the electronics assembly <NUM> to establish communication between the control electronics <NUM> and the motor assembly <NUM>. In response to command signals from the control electronics <NUM> that operate a motor driver (e.g., a power converter) to regulate the amount of power supplied to the motor from a power supply, the motor actuates the drive train components of the drive system <NUM> to displace the slide <NUM> in the axial direction <NUM> to force fluid from the reservoir <NUM> along a fluid path (including tubing <NUM> and an infusion set), thereby administering doses of the fluid contained in the reservoir <NUM> into the user's body. Preferably, the power supply is realized one or more batteries contained within the housing <NUM>. Alternatively, the power supply may be a solar panel, capacitor, AC or DC power supplied through a power cord, or the like. In some embodiments, the control electronics <NUM> may operate the motor of the motor assembly <NUM> and/or drive system <NUM> in a stepwise manner, typically on an intermittent basis; to administer discrete precise doses of the fluid to the user according to programmed delivery profiles.

Referring to <FIG>, as described above, the user interface <NUM> includes HMI elements, such as buttons <NUM> and a directional pad <NUM>, that are formed on a graphic keypad overlay <NUM> that overlies a keypad assembly <NUM>, which includes features corresponding to the buttons <NUM>, directional pad <NUM> or other user interface items indicated by the graphic keypad overlay <NUM>. When assembled, the keypad assembly <NUM> is coupled to the control electronics <NUM>, thereby allowing the HMI elements <NUM>, <NUM> to be manipulated by the user to interact with the control electronics <NUM> and control operation of the infusion pump <NUM>, for example, to administer a bolus of insulin, to change therapy settings, to change user preferences, to select display features, to set or disable alarms and reminders, and the like. In this regard, the control electronics <NUM> maintains and/or provides information to the display <NUM> regarding program parameters, delivery profiles, pump operation, alarms, warnings, statuses, or the like, which may be adjusted using the HMI elements <NUM>, <NUM>. In various embodiments, the HMI elements <NUM>, <NUM> may be realized as physical objects (e.g., buttons, knobs, joysticks, and the like) or virtual objects (e.g., using touch-sensing and/or proximity-sensing technologies). For example, in some embodiments, the display <NUM> may be realized as a touch screen or touch-sensitive display, and in such embodiments, the features and/or functionality of the HMI elements <NUM>, <NUM> may be integrated into the display <NUM> and the HMI <NUM> may not be present. In some embodiments, the electronics assembly <NUM> may also include alert generating elements coupled to the control electronics <NUM> and suitably configured to generate one or more types of feedback, such as, without limitation: audible feedback; visual feedback; haptic (physical) feedback; or the like.

Referring to <FIG>, in accordance with one or more embodiments, the sensor assembly <NUM> includes a back plate structure <NUM> and a loading element <NUM>. The loading element <NUM> is disposed between the capping member <NUM> and a beam structure <NUM> that includes one or more beams having sensing elements disposed thereon that are influenced by compressive force applied to the sensor assembly <NUM> that deflects the one or more beams, as described in greater detail in <CIT>, In exemplary embodiments, the back plate structure <NUM> is affixed, adhered, mounted, or otherwise mechanically coupled to the bottom surface <NUM> of the drive system <NUM> such that the back plate structure <NUM> resides between the bottom surface <NUM> of the drive system <NUM> and the housing cap <NUM>. The drive system capping member <NUM> is contoured to accommodate and conform to the bottom of the sensor assembly <NUM> and the drive system <NUM>. The drive system capping member <NUM> may be affixed to the interior of the housing <NUM> to prevent displacement of the sensor assembly <NUM> in the direction opposite the direction of force provided by the drive system <NUM> (e.g., the direction opposite direction <NUM>). Thus, the sensor assembly <NUM> is positioned between the motor assembly <NUM> and secured by the capping member <NUM>, which prevents displacement of the sensor assembly <NUM> in a downward direction opposite the direction of arrow <NUM>, such that the sensor assembly <NUM> is subjected to a reactionary compressive force when the drive system <NUM> and/or motor assembly <NUM> is operated to displace the slide <NUM> in the axial direction <NUM> in opposition to the fluid pressure in the reservoir <NUM>. Under normal operating conditions, the compressive force applied to the sensor assembly <NUM> is correlated with the fluid pressure in the reservoir <NUM>. As shown, electrical leads <NUM> are adapted to electrically couple the sensing elements of the sensor assembly <NUM> to the electronics assembly <NUM> to establish communication to the control electronics <NUM>, wherein the control electronics <NUM> are configured to measure, receive, or otherwise obtain electrical signals from the sensing elements of the sensor assembly <NUM> that are indicative of the force applied by the drive system <NUM> in the axial direction <NUM>.

<FIG> depicts an exemplary embodiment of a control system <NUM> suitable for use with an infusion device <NUM>, such as the infusion device <NUM> in <FIG> or the infusion device <NUM> of <FIG>. The control system <NUM> is capable of controlling or otherwise regulating a physiological condition in the body <NUM> of a user to a desired (or target) value or otherwise maintain the condition within a range of acceptable values in an automated or autonomous manner. In one or more exemplary embodiments, the condition being regulated is sensed, detected, measured or otherwise quantified by a sensing arrangement <NUM> (e.g., sensing arrangement <NUM>) communicatively coupled to the infusion device <NUM>. However, it should be noted that in alternative embodiments, the condition being regulated by the control system <NUM> may be correlative to the measured values obtained by the sensing arrangement <NUM>. That said, for clarity and purposes of explanation, the subject matter may be described herein in the context of the sensing arrangement <NUM> being realized as a glucose sensing arrangement that senses, detects, measures or otherwise quantifies the user's glucose level, which is being regulated in the body <NUM> of the user by the control system <NUM>.

In exemplary embodiments, the sensing arrangement <NUM> includes one or more interstitial glucose sensing elements that generate or otherwise output electrical signals having a signal characteristic that is correlative to, influenced by, or otherwise indicative of the relative interstitial fluid glucose level in the body <NUM> of the user. The output electrical signals are filtered or otherwise processed to obtain a measurement value indicative of the user's interstitial fluid glucose level. In exemplary embodiments, a blood glucose meter <NUM>, such as a finger stick device, is utilized to directly sense, detect, measure or otherwise quantify the blood glucose in the body <NUM> of the user. In this regard, the blood glucose meter <NUM> outputs or otherwise provides a measured blood glucose value that may be utilized as a reference measurement for calibrating the sensing arrangement <NUM> and converting a measurement value indicative of the user's interstitial fluid glucose level into a corresponding calibrated blood glucose value. For purposes of explanation, the calibrated blood glucose value calculated based on the electrical signals output by the sensing element(s) of the sensing arrangement <NUM> may alternatively be referred to herein as the sensor glucose value, the sensed glucose value, or variants thereof.

In the illustrated embodiment, the pump control system <NUM> generally represents the electronics and other components of the infusion device <NUM> that control operation of the fluid infusion device <NUM> according to a desired infusion delivery program in a manner that is influenced by the sensed glucose value indicative of a current glucose level in the body <NUM> of the user. For example, to support a closed-loop operating mode, the pump control system <NUM> maintains, receives, or otherwise obtains a target or commanded glucose value, and automatically generates or otherwise determines dosage commands for operating an actuation arrangement, such as a motor <NUM>, to displace the plunger <NUM> and deliver insulin to the body <NUM> of the user based on the difference between a sensed glucose value and the target glucose value. In other operating modes, the pump control system <NUM> may generate or otherwise determine dosage commands configured to maintain the sensed glucose value below an upper glucose limit, above a lower glucose limit, or otherwise within a desired range of glucose values. In practice, the infusion device <NUM> may store or otherwise maintain the target value, upper and/or lower glucose limit(s), and/or other glucose threshold value(s) in a data storage element accessible to the pump control system <NUM>.

The target glucose value and other threshold glucose values may be received from an external component (e.g., CCD <NUM> and/or computing device <NUM>) or be input by a user via a user interface element <NUM> associated with the infusion device <NUM>. In practice, the one or more user interface element(s) <NUM> associated with the infusion device <NUM> typically include at least one input user interface element, such as, for example, a button, a keypad, a keyboard, a knob, a joystick, a mouse, a touch panel, a touchscreen, a microphone or another audio input device, and/or the like. Additionally, the one or more user interface element(s) <NUM> include at least one output user interface element, such as, for example, a display element (e.g., a light-emitting diode or the like), a display device (e.g., a liquid crystal display or the like), a speaker or another audio output device, a haptic feedback device, or the like, for providing notifications or other information to the user. It should be noted that although <FIG> depicts the user interface element(s) <NUM> as being separate from the infusion device <NUM>, in practice, one or more of the user interface element(s) <NUM> may be integrated with the infusion device <NUM>. Furthermore, in some embodiments, one or more user interface element(s) <NUM> are integrated with the sensing arrangement <NUM> in addition to and/or in alternative to the user interface element(s) <NUM> integrated with the infusion device <NUM>. The user interface element(s) <NUM> may be manipulated by the user to operate the infusion device <NUM> to deliver correction boluses, adjust target and/or threshold values, modify the delivery control scheme or operating mode, and the like, as desired.

Still referring to <FIG>, in the illustrated embodiment, the infusion device <NUM> includes a motor control module <NUM> coupled to a motor <NUM> (e.g., motor assembly <NUM>) that is operable to displace a plunger <NUM> (e.g., plunger <NUM>) in a reservoir (e.g., reservoir <NUM>) and provide a desired amount of fluid to the body <NUM> of a user. In this regard, displacement of the plunger <NUM> results in the delivery of a fluid that is capable of influencing the condition in the body <NUM> of the user to the body <NUM> of the user via a fluid delivery path (e.g., via tubing <NUM> of an infusion set <NUM>). A motor driver module <NUM> is coupled between an energy source <NUM> and the motor <NUM>. The motor control module <NUM> is coupled to the motor driver module <NUM>, and the motor control module <NUM> generates or otherwise provides command signals that operate the motor driver module <NUM> to provide current (or power) from the energy source <NUM> to the motor <NUM> to displace the plunger <NUM> in response to receiving, from a pump control system <NUM>, a dosage command indicative of the desired amount of fluid to be delivered.

In exemplary embodiments, the energy source <NUM> is realized as a battery housed within the infusion device <NUM> (e.g., within housing <NUM>) that provides direct current (DC) power. In this regard, the motor driver module <NUM> generally represents the combination of circuitry, hardware and/or other electrical components configured to convert or otherwise transfer DC power provided by the energy source <NUM> into alternating electrical signals applied to respective phases of the stator windings of the motor <NUM> that result in current flowing through the stator windings that generates a stator magnetic field and causes the rotor of the motor <NUM> to rotate. The motor control module <NUM> is configured to receive or otherwise obtain a commanded dosage from the pump control system <NUM>, convert the commanded dosage to a commanded translational displacement of the plunger <NUM>, and command, signal, or otherwise operate the motor driver module <NUM> to cause the rotor of the motor <NUM> to rotate by an amount that produces the commanded translational displacement of the plunger <NUM>. For example, the motor control module <NUM> may determine an amount of rotation of the rotor required to produce translational displacement of the plunger <NUM> that achieves the commanded dosage received from the pump control system <NUM>. Based on the current rotational position (or orientation) of the rotor with respect to the stator that is indicated by the output of the rotor sensing arrangement <NUM>, the motor control module <NUM> determines the appropriate sequence of alternating electrical signals to be applied to the respective phases of the stator windings that should rotate the rotor by the determined amount of rotation from its current position (or orientation). In embodiments where the motor <NUM> is realized as a BLDC motor, the alternating electrical signals commutate the respective phases of the stator windings at the appropriate orientation of the rotor magnetic poles with respect to the stator and in the appropriate order to provide a rotating stator magnetic field that rotates the rotor in the desired direction. Thereafter, the motor control module <NUM> operates the motor driver module <NUM> to apply the determined alternating electrical signals (e.g., the command signals) to the stator windings of the motor <NUM> to achieve the desired delivery of fluid to the user.

When the motor control module <NUM> is operating the motor driver module <NUM>, current flows from the energy source <NUM> through the stator windings of the motor <NUM> to produce a stator magnetic field that interacts with the rotor magnetic field. In some embodiments, after the motor control module <NUM> operates the motor driver module <NUM> and/or motor <NUM> to achieve the commanded dosage, the motor control module <NUM> ceases operating the motor driver module <NUM> and/or motor <NUM> until a subsequent dosage command is received. In this regard, the motor driver module <NUM> and the motor <NUM> enter an idle state during which the motor driver module <NUM> effectively disconnects or isolates the stator windings of the motor <NUM> from the energy source <NUM>. In other words, current does not flow from the energy source <NUM> through the stator windings of the motor <NUM> when the motor <NUM> is idle, and thus, the motor <NUM> does not consume power from the energy source <NUM> in the idle state, thereby improving efficiency.

Depending on the embodiment, the motor control module <NUM> may be implemented or realized with a general purpose processor, a microprocessor, a controller, a microcontroller, a state machine, a content addressable memory, an application specific integrated circuit, a field programmable gate array, any suitable programmable logic device, discrete gate or transistor logic, discrete hardware components, or any combination thereof, designed to perform the functions described herein. In exemplary embodiments, the motor control module <NUM> includes or otherwise accesses a data storage element or memory, including any sort of random access memory (RAM), read only memory (ROM), flash memory, registers, hard disks, removable disks, magnetic or optical mass storage, or any other short or long term storage media or other non-transitory computer-readable medium, which is capable of storing programming instructions for execution by the motor control module <NUM>. The computer-executable programming instructions, when read and executed by the motor control module <NUM>, cause the motor control module <NUM> to perform or otherwise support the tasks, operations, functions, and processes described herein.

It should be appreciated that <FIG> is a simplified representation of the infusion device <NUM> for purposes of explanation and is not intended to limit the subject matter described herein in any way. In this regard, depending on the embodiment, some features and/or functionality of the sensing arrangement <NUM> may implemented by or otherwise integrated into the pump control system <NUM>, or vice versa. Similarly, in practice, the features and/or functionality of the motor control module <NUM> may implemented by or otherwise integrated into the pump control system <NUM>, or vice versa. Furthermore, the features and/or functionality of the pump control system <NUM> may be implemented by control electronics <NUM> located in the fluid infusion device <NUM>, <NUM>, while in alternative embodiments, the pump control system <NUM> may be implemented by a remote computing device that is physically distinct and/or separate from the infusion device <NUM>, such as, for example, the CCD <NUM> or the computing device <NUM>.

<FIG> depicts an exemplary embodiment of a pump control system <NUM> suitable for use as the pump control system <NUM> in <FIG> in accordance with one or more embodiments. The illustrated pump control system <NUM> includes, without limitation, a pump control module <NUM>, a communications interface <NUM>, and a data storage element (or memory) <NUM>. The pump control module <NUM> is coupled to the communications interface <NUM> and the memory <NUM>, and the pump control module <NUM> is suitably configured to support the operations, tasks, and/or processes described herein. In exemplary embodiments, the pump control module <NUM> is also coupled to one or more user interface elements <NUM> (e.g., user interface <NUM>, <NUM>) for receiving user input and providing notifications, alerts, or other therapy information to the user. Although <FIG> depicts the user interface element <NUM> as being separate from the pump control system <NUM>, in various alternative embodiments, the user interface element <NUM> may be integrated with the pump control system <NUM> (e.g., as part of the infusion device <NUM>, <NUM>), the sensing arrangement <NUM> or another element of an infusion system <NUM> (e.g., the computer <NUM> or CCD <NUM>).

Referring to <FIG> and with reference to <FIG>, the communications interface <NUM> generally represents the hardware, circuitry, logic, firmware and/or other components of the pump control system <NUM> that are coupled to the pump control module <NUM> and configured to support communications between the pump control system <NUM> and the sensing arrangement <NUM>. In this regard, the communications interface <NUM> may include or otherwise be coupled to one or more transceiver modules capable of supporting wireless communications between the pump control system <NUM>, <NUM> and the sensing arrangement <NUM> or another electronic device <NUM>, <NUM> in an infusion system <NUM>. In other embodiments, the communications interface <NUM> may be configured to support wired communications to/from the sensing arrangement <NUM>.

The pump control module <NUM> generally represents the hardware, circuitry, logic, firmware and/or other component of the pump control system <NUM> that is coupled to the communications interface <NUM> and configured to determine dosage commands for operating the motor <NUM> to deliver fluid to the body <NUM> based on data received from the sensing arrangement <NUM> and perform various additional tasks, operations, functions and/or operations described herein. For example, in exemplary embodiments, pump control module <NUM> implements or otherwise executes a command generation application <NUM> that supports one or more autonomous operating modes and calculates or otherwise determines dosage commands for operating the motor <NUM> of the infusion device <NUM> in an autonomous operating mode based at least in part on a current measurement value for a condition in the body <NUM> of the user. For example, in a closed-loop operating mode, the command generation application <NUM> may determine a dosage command for operating the motor <NUM> to deliver insulin to the body <NUM> of the user based at least in part on the current glucose measurement value most recently received from the sensing arrangement <NUM> to regulate the user's blood glucose level to a target reference glucose value. Additionally, the command generation application <NUM> may generate dosage commands for boluses that are manually-initiated or otherwise instructed by a user via a user interface element <NUM>. For example, regardless of the operating mode being implemented, the command generation application <NUM> may determine a dosage command for operating the motor <NUM> to deliver a bolus of insulin to the body <NUM> of the user that corresponds to a correction bolus or meal bolus amount selected or otherwise indicated by the user via the user interface element <NUM>, <NUM>, <NUM>.

Still referring to <FIG>, depending on the embodiment, the pump control module <NUM> may be implemented or realized with a general purpose processor, a microprocessor, a controller, a microcontroller, a state machine, a content addressable memory, an application specific integrated circuit, a field programmable gate array, any suitable programmable logic device, discrete gate or transistor logic, discrete hardware components, or any combination thereof, designed to perform the functions described herein. In this regard, the steps of a method or algorithm described in connection with the embodiments disclosed herein may be embodied directly in hardware, in firmware, in a software module executed by the pump control module <NUM>, or in any practical combination thereof. In exemplary embodiments, the pump control module <NUM> includes or otherwise accesses the data storage element or memory <NUM>, which may be realized using any sort of non-transitory computer-readable medium capable of storing programming instructions for execution by the pump control module <NUM>. The computer-executable programming instructions, when read and executed by the pump control module <NUM>, cause the pump control module <NUM> to implement or otherwise generate the command generation application <NUM> and perform the tasks, operations, functions, and processes described in greater detail below.

It should be understood that <FIG> is a simplified representation of a pump control system <NUM> for purposes of explanation and is not intended to limit the subject matter described herein in any way. For example, in some embodiments, the features and/or functionality of the motor control module <NUM> may be implemented by or otherwise integrated into the pump control system <NUM> and/or the pump control module <NUM>, for example, by the command generation application <NUM> converting the dosage command into a corresponding motor command, in which case, the separate motor control module <NUM> may be absent from an embodiment of the infusion device <NUM>.

<FIG> depicts an exemplary closed-loop control system <NUM> that may be implemented by a pump control system <NUM>, <NUM> to provide a closed-loop operating mode that autonomously regulates a condition in the body of a user to a reference (or target) value. It should be appreciated that <FIG> is a simplified representation of the control system <NUM> for purposes of explanation and is not intended to limit the subject matter described herein in any way.

In exemplary embodiments, the control system <NUM> receives or otherwise obtains a target glucose value at input <NUM>. In some embodiments, the target glucose value may be stored or otherwise maintained by the infusion device <NUM> (e.g., in memory <NUM>), however, in some alternative embodiments, the target value may be received from an external component (e.g., CCD <NUM> and/or computer <NUM>). In one or more embodiments, the target glucose value may be dynamically calculated or otherwise determined prior to entering the closed-loop operating mode based on one or more patient-specific control parameters. For example, the target blood glucose value may be calculated based at least in part on a patient-specific reference basal rate and a patient-specific daily insulin requirement, which are determined based on historical delivery information over a preceding interval of time (e.g., the amount of insulin delivered over the preceding <NUM> hours). The control system <NUM> also receives or otherwise obtains a current glucose measurement value (e.g., the most recently obtained sensor glucose value) from the sensing arrangement <NUM> at input <NUM>. The illustrated control system <NUM> implements or otherwise provides proportional-integral-derivative (PID) control to determine or otherwise generate delivery commands for operating the motor <NUM> based at least in part on the difference between the target glucose value and the current glucose measurement value. In this regard, the PID control attempts to minimize the difference between the measured value and the target value, and thereby regulates the measured value to the desired value. PID control parameters are applied to the difference between the target glucose level at input <NUM> and the measured glucose level at input <NUM> to generate or otherwise determine a dosage (or delivery) command provided at output <NUM>. Based on that delivery command, the motor control module <NUM> operates the motor <NUM> to deliver insulin to the body of the user to influence the user's glucose level, and thereby reduce the difference between a subsequently measured glucose level and the target glucose level.

The illustrated control system <NUM> includes or otherwise implements a summation block <NUM> configured to determine a difference between the target value obtained at input <NUM> and the measured value obtained from the sensing arrangement <NUM> at input <NUM>, for example, by subtracting the target value from the measured value. The output of the summation block <NUM> represents the difference between the measured and target values, which is then provided to each of a proportional term path, an integral term path, and a derivative term path. The proportional term path includes a gain block <NUM> that multiplies the difference by a proportional gain coefficient, KP, to obtain the proportional term. The integral term path includes an integration block <NUM> that integrates the difference and a gain block <NUM> that multiplies the integrated difference by an integral gain coefficient, KI, to obtain the integral term. The derivative term path includes a derivative block <NUM> that determines the derivative of the difference and a gain block <NUM> that multiplies the derivative of the difference by a derivative gain coefficient, KD, to obtain the derivative term. The proportional term, the integral term, and the derivative term are then added or otherwise combined to obtain a delivery command that is utilized to operate the motor at output <NUM>. Various implementation details pertaining to closed-loop PID control and determine gain coefficients are described in greater detail in <CIT>,.

In one or more exemplary embodiments, the PID gain coefficients are user-specific (or patient-specific) and dynamically calculated or otherwise determined prior to entering the closed-loop operating mode based on historical insulin delivery information (e.g., amounts and/or timings of previous dosages, historical correction bolus information, or the like), historical sensor measurement values, historical reference blood glucose measurement values, user-reported or user-input events (e.g., meals, exercise, and the like), and the like. In this regard, one or more patient-specific control parameters (e.g., an insulin sensitivity factor, a daily insulin requirement, an insulin limit, a reference basal rate, a reference fasting glucose, an active insulin action duration, pharmodynamical time constants, or the like) may be utilized to compensate, correct, or otherwise adjust the PID gain coefficients to account for various operating conditions experienced and/or exhibited by the infusion device <NUM>. The PID gain coefficients may be maintained by the memory <NUM> accessible to the pump control module <NUM>. In this regard, the memory <NUM> may include a plurality of registers associated with the control parameters for the PID control. For example, a first parameter register may store the target glucose value and be accessed by or otherwise coupled to the summation block <NUM> at input <NUM>, and similarly, a second parameter register accessed by the proportional gain block <NUM> may store the proportional gain coefficient, a third parameter register accessed by the integration gain block <NUM> may store the integration gain coefficient, and a fourth parameter register accessed by the derivative gain block <NUM> may store the derivative gain coefficient.

In exemplary embodiments described herein, a pump control system <NUM>, <NUM> is configured to detect a rescue condition which should be nonactionable in terms of insulin delivery based on the glucose measurement values obtained from the sensing arrangement <NUM> while autonomously operating the infusion device <NUM>, and in response, automatically caps, limits, or otherwise restricts insulin delivery temporarily, thereby limiting the response or action that would otherwise be taken by the infusion device <NUM> autonomously in response to the rescue condition. Thus, when a user consumes fast-acting (or "rescue") carbohydrates to avoid a potential hypoglycemic event while the infusion device is in a closed-loop operating mode, the pump control system <NUM>, <NUM> recognizes a change in one or more characteristic(s) of the glucose measurement values indicative of a rescue condition and adjusts the autonomous operation of the infusion device in a manner that temporarily reduces insulin delivery. In this regard, once the rescue condition has expired or otherwise elapsed, the pump control system <NUM>, <NUM> restores the delivery of insulin to the preceding delivery settings. Thus, the pump control system <NUM>, <NUM> essentially treats a detected rescue condition a nonactionable event and alters the autonomous operation to allow the carbohydrates consumed by the user to achieve their intended effect before resuming normal or preceding regulation of the user's glucose level.

<FIG> depicts an exemplary rescue management process <NUM> suitable for implementation by a control system associated with a fluid infusion device, such as a control system <NUM>, <NUM>, <NUM> in the infusion device <NUM>, to automatically adjust the fluid delivery in a manner that accounts for events that should essentially be nonactionable, such as a rescue condition attributable to a user consuming rescue carbohydrates. For purposes of explanation, the subject matter is described herein in the context of detecting a rescue condition during implementation of a closed-loop operating mode to regulate a user's glucose level; however, it should be appreciated that the subject matter described herein is not necessarily limited to any particular initial operating mode or any particular type of condition being detected.

The various tasks performed in connection with the rescue management process <NUM> may be performed by hardware, firmware, software executed by processing circuitry, or any combination thereof. For illustrative purposes, the following description refers to elements mentioned above in connection with <FIG>. In practice, portions of the rescue management process <NUM> may be performed by different elements of the control system <NUM>, such as, for example, the infusion device <NUM>, the sensing arrangement <NUM>, the pump control system <NUM>, <NUM>, the pump control module <NUM>, and/or the command generation application <NUM>. It should be appreciated that the rescue management process <NUM> may include any number of additional or alternative tasks, the tasks need not be performed in the illustrated order and/or the tasks may be performed concurrently, and/or the rescue management process <NUM> may be incorporated into a more comprehensive procedure or process having additional functionality not described in detail herein. Moreover, one or more of the tasks shown and described in the context of <FIG> could be omitted from a practical embodiment of the rescue management process <NUM> as long as the intended overall functionality remains intact.

Referring to <FIG> with continued reference to <FIG>, in exemplary embodiments, the rescue management process <NUM> is performed while an infusion device is being operated in an autonomous operating mode, such as a closed-loop operating mode. The rescue management process initializes or otherwise begins by obtaining the current (or most recent) glucose measurement from the sensing arrangement and determines whether the current glucose measurement is less than a rescue monitoring threshold (tasks <NUM>, <NUM>). The control system <NUM>, <NUM> compares the current sensor glucose measurement value from the sensing arrangement <NUM> (e.g., the value input to the closed-loop control system <NUM> at input <NUM>) to a monitoring threshold value and detects or otherwise identifies when the current glucose measurement value is less than the monitoring threshold value. In this regard, the rescue monitoring threshold value corresponds to a glucose level below which a user is likely to consume rescue carbohydrates so that the rescue management process <NUM> does not limit insulin delivery at higher glucose levels where it is unlikely that the user will consume rescue carbohydrates. For example, in one or more embodiments, a threshold value for alerting the user to a potential hypoglycemic event may also be utilized as the rescue monitoring threshold value, or alternatively, the rescue monitoring threshold value may be equal to an alerting threshold value plus an offset value (e.g., to account for a user manually identifying a potential hypoglycemic condition and consuming rescue carbohydrates in advance of an alert). In embodiments where the pump control system <NUM>, <NUM> is configured to alert a user to consume rescue carbohydrates, the rescue monitoring threshold value may be equal to the threshold value used to generate the rescue carbohydrate alert.

When the rescue management process <NUM> identifies the current glucose measurement is greater than the rescue monitoring threshold, the autonomous operation of the infusion device is maintained in its current state. For example, in a closed-loop operating mode, the pump control system <NUM>, <NUM> may autonomously operate the motor <NUM> of the infusion device <NUM> to deliver a variable rate of insulin infusion based at least in part on the difference between the current sensor glucose measurement value and a target glucose value configured to regulate the sensor glucose measurement values to the target glucose value, as described above in the context of <FIG>.

When the rescue management process <NUM> identifies the current glucose measurement is less than the rescue monitoring threshold, the rescue management process <NUM> verifies or otherwise confirms that there has not been a meal announcement (task <NUM>). In this regard, when a user manipulates the user interface <NUM>, <NUM> to initiate a meal bolus or otherwise indicate that a meal is about to be consumed, the rescue management process <NUM> exits or otherwise terminates, thereby allowing the meal bolus to be delivered unimpeded and with the autonomous operating mode maintaining its current manner of glucose regulation.

In the absence of a meal announcement, the rescue management process <NUM> monitors or otherwise analyzes subsequent glucose measurements for one or more characteristics indicative of the user having consumed rescue carbohydrates and detects a rescue condition with the characteristic(s) violate a rescue threshold (tasks <NUM>, <NUM>). In exemplary embodiments, for each new glucose measurement value received during a monitoring window after detecting a glucose measurement below the monitoring threshold, the pump control system <NUM>, <NUM> calculates or otherwise determines a rate of change associated with the respective glucose measurement value and detects a rescue condition when the rate of change associated with the current (or most recent) glucose measurement value exceeds a rescue threshold. For example, the pump control system <NUM>, <NUM> may calculate the rate of change as the difference between the current sensor glucose measurement and the preceding sensor glucose measurement, where the rescue threshold value represents a change in glucose measurement values over successive samplings indicative of the user having consumed fast-acting rescue carbohydrates. In some embodiments, one or more of the current sensor glucose measurement, the preceding sensor glucose measurement and/or the rate of change associated with the current sensor glucose measurement may be determined by filtering a plurality of preceding glucose measurements. For example, the current sensor glucose measurement most recently received from a sensing arrangement <NUM> may be updated every <NUM> minutes, where each current sensor glucose measurement is a filtered average of five preceding output signals sampled at one minute intervals from the sensing element sensitive to a user's glucose level, resulting in a filtered measurement indicative of the user's current glucose level. Some examples of such filtering are described in <CIT>,.

In the absence of glucose measurements indicative of a rescue condition, the rescue management process <NUM> verifies or otherwise determines whether the rescue monitoring window has elapsed or expired (task <NUM>). In this regard, the pump control system <NUM>, <NUM> initiates a timer upon detecting a glucose measurement less than a rescue monitoring threshold and ceases monitoring for a rescue condition once the timer value exceeds a value corresponding to a monitoring window duration. The rescue monitoring window duration corresponds to an average duration or time period after consumption during which fast-acting rescue carbohydrates are likely to exhibit an effect on the user's sensor glucose measurement values. For example, the rescue monitoring window duration may be chosen to be <NUM> minutes or less. In this regard, when the rate of change between any two successive measurement values does not violate the rescue condition detection threshold within the rescue monitoring window, it may be presumed that any carbohydrates consumed were not fast-acting and therefore should be responded to in a normal manner as dictated by the current control scheme or operating mode in effect.

In the illustrated embodiment, the rescue management process <NUM> terminates or exits when the monitoring window has elapsed, thereby maintaining the normal autonomous operation of the infusion device. However, in other embodiments, the rescue management process <NUM> may repeat the task of determining whether the current glucose measurement is less than the rescue monitoring threshold after expiration of the monitoring window (task <NUM>), and if so, the rescue management process <NUM> repeats the loop defined by tasks <NUM>, <NUM>, <NUM>, <NUM> to detect or otherwise identify a potential rescue condition for as long as the glucose measurements are less than the rescue monitoring threshold upon expiration of a monitoring window. Thus, the rescue management process <NUM> may continue to monitor for a rescue condition for as long as the current glucose measurement is less than the rescue monitoring threshold until the user's glucose measurements rise above the rescue monitoring threshold to a more normal level.

In response to detecting a rescue condition, the rescue management process <NUM> automatically modifies or otherwise adjusts one or more delivery settings utilized for autonomously operating the infusion device to limit or otherwise restrict the delivery of fluid for a temporary period of time (tasks <NUM>, <NUM>). For example, in one embodiment, the pump control system <NUM>, <NUM> modifies or otherwise adjusts the maximum delivery rate or maximum dosage associated with the autonomous operating mode from an initial value to a lower value to temporarily cap the dosage commands generated based on the user's glucose measurement values. In this regard, as a difference between the user's current or predicted glucose measurement value increases in response to the user metabolizing the rescue carbohydrates, the dosage command generated by the pump control system <NUM>, <NUM> based on that difference in a closed-loop operating mode may be reduced or otherwise constrained to the maximum dosage, regardless of the magnitude of the difference. For example, the maximum delivery rate for the closed-loop operating mode may be temporarily set to a patient-specific safe basal rate of infusion, which may be a fraction of the normal maximum delivery rate for the closed-loop operating mode. In this manner, the response time for the closed-loop control is increased, thereby reducing the autonomous response or action taken in response to the rescue carbohydrates. In another embodiment, the pump control system <NUM>, <NUM> modifies or otherwise adjusts values for one or more control parameters (e.g., one or more PID gain coefficients <NUM>, <NUM>, <NUM>) to decrease the responsiveness of the autonomous control scheme and thereby limit the dosage or delivery rate that would otherwise be implemented in response to the rise in the user's glucose level.

In one or more embodiments, the pump control system <NUM>, <NUM> automatically transitions from a closed-loop operating mode to a rescue mode having an associated maximum delivery rate (or maximum dosage) that is less than the maximum delivery rate associated with the closed-loop operating mode. In the rescue mode, the pump control system <NUM>, <NUM> may continue to generate dosage commands in a manner that is influenced by the current glucose measurement value (or a predicted glucose measurement value based thereon) in a similar manner as is done in the closed-loop operating mode, albeit with the dosage commands being capped or limited to a lower maximum value. In other embodiments, the pump control system <NUM>, <NUM> may generate dosage commands in a manner similar to the closed-loop operating mode, but with the dosage commands being proportionally scaled down, for example, based on the ratio of the limited maximum delivery rate to the normal closed-loop maximum delivery rate. In yet other embodiments, the rescue mode may correspond to a preexisting safe mode supported by the infusion device <NUM>, in which case the pump control system <NUM>, <NUM> automatically transitions from a closed-loop operating mode to the safe mode in response to the rescue condition. The safe mode is characterized by a reduced or limited rate of delivery of insulin relative to the normal closed-loop operating mode, for example, by having a lower maximum delivery rate, control parameters coefficients adjusted for a slower response time, or the like.

Still referring to <FIG>, while autonomously operating the infusion device in a manner that limits delivery, the rescue management process <NUM> monitors for an exit condition, and in response to detecting an exit condition, the rescue management process <NUM> automatically restores the infusion delivery to the initial configuration or settings prior to detecting the rescue condition (tasks <NUM>, <NUM>). For example, in one or more embodiments, the pump control system <NUM>, <NUM> may continually monitor or otherwise analyze glucose and/or predicted glucose measurement values received from the sensing arrangement <NUM> to detect or otherwise identify an absence of a rescue condition. In this regard, the pump control system <NUM>, <NUM> may detect characteristics of the glucose measurement values indicative of the rescue carbohydrates being metabolized by the user, such as, for example, when a rate of change between several successive glucose measurement values is less than or equal to zero. In other embodiments, the pump control system <NUM>, <NUM> identify the absence of the rescue condition when several successive glucose and/or predicted glucose measurement values are greater than a threshold value indicative of the rescue carbohydrates having achieved their intended effect, thereby resuming insulin delivery by the automated closed-loop glucose control system in response to a continuing rise of blood sugar to maintain good glycemic control.

In exemplary embodiments, the pump control system <NUM>, <NUM> also detects or otherwise identifies an exit condition in response to a meal announcement or other indication of a meal received from the user. Additionally, in one or more embodiments, the pump control system <NUM>, <NUM> initiates a timer upon entering the rescue mode or otherwise initiating the limited delivery (e.g., task <NUM>) and automatically terminating the rescue mode when the timer value exceeds a maximum threshold duration for the rescue recovery period. Thus, the pump control system <NUM>, <NUM> ensures the period of limited delivery is only temporary before reverting back to the original delivery configuration for continued regulation of the user's glucose level. In an exemplary embodiment, the maximum threshold duration is a fixed duration of time that the safe (or reduced) delivery rate can be delivered without adversely affecting the glycemic outcome. That said, in other embodiments, the maximum threshold duration may be customizable or patient-specific to reflect varying physiological responses. For example, the maximum threshold duration may be chosen to be equal to a typical postprandial period required for the user's glucose level to peak after consuming rescue carbohydrates, thereby allowing the normal delivery configuration to assist in reducing the user's glucose level if the sensor glucose measurements do not exhibit a postprandial dip. In such embodiments, a patient-specific maximum threshold duration may be determined based on historical measurement data or the like to reflect each user's individual physiology and varying amount of time for reaching a postprandial peak.

It should be noted that any number of exit conditions may be monitored for and/or detected in parallel. For example, the pump control system <NUM>, <NUM> may continually monitor sensor glucose measurement values and characteristics thereof for indication that the rescue condition is no longer present while also implementing a timeout period and monitoring for any potential meal announcements. By limiting the limited insulin delivery to a temporary duration, rescue carbohydrates may be allowed to achieve their intended effect without risking a potential hyperglycemic event.

After identifying an exit condition, the pump control system <NUM>, <NUM> automatically restores operation of the infusion device <NUM> to the initial operating mode and/or the initial delivery settings prior to detecting the rescue condition. For example, the pump control system <NUM>, <NUM> may restore a maximum delivery rate and/or dosage criteria associated with the closed-loop operating mode. Similarly, if other control parameters for the closed-loop operating mode were adjusted (e.g., PID gain coefficients), the pump control system <NUM>, <NUM> may restore those control parameters to their initial values. In other embodiments, the pump control system <NUM>, <NUM> restores the original insulin delivery by automatically transitioning from a rescue mode (or safe mode) back to the original closed-loop operating mode or other autonomous mode preceding the rescue mode. Thus, the pump control system <NUM>, <NUM> may resume operating the motor <NUM> in a manner configured to reduce the difference between the current sensor glucose measurement from the sensing arrangement <NUM> and a target glucose value as described above.

To briefly summarize, the subject matter described herein allows for unannounced rescue carbohydrates consumed by a user to achieve their intended effect unimpeded by the current operating mode in effect when they were consumed by temporarily limiting the delivery of insulin. In this manner, potential hypoglycemic events are more readily avoided by consumption of rescue carbohydrates. At the same time, the period of limited delivery is itself limited, so as to not interfere with long-term regulation of the user's glucose level and provide protection from hyperglycemic events. Accordingly, better overall regulation of the user's glucose level can be achieved without requiring the user to undertake any additional actions upon consuming rescue carbohydrates (i.e., the user does not need to determine the amount of carbohydrates and make a corresponding announcement, manually suspend delivery, or the like).

For the sake of brevity, conventional techniques related to glucose sensing and/or monitoring, closed-loop glucose control, and other functional aspects of the subject matter may not be described in detail herein. In addition, certain terminology may also be used in the herein for the purpose of reference only, and thus is not intended to be limiting. For example, terms such as "first", "second", and other such numerical terms referring to structures do not imply a sequence or order unless clearly indicated by the context. The foregoing description may also refer to elements or nodes or features being "connected" or "coupled" together. As used herein, unless expressly stated otherwise, "coupled" means that one element/node/feature is directly or indirectly joined to (or directly or indirectly communicates with) another element/node/feature, and not necessarily mechanically.

Claim 1:
An infusion device (<NUM>) comprising:
an actuation arrangement (<NUM>) operable to deliver fluid to a body of a user, the fluid influencing a physiological condition of the user;
a control module (<NUM>) coupled to the actuation arrangement (<NUM>) to autonomously operate the actuation arrangement to:
deliver a variable rate of infusion based on measurement values;
detect a rescue condition (<NUM>) based on the measurement values when a rate of change associated with a first measurement value of the one or more measurement values is greater than a rescue detection threshold after a preceding measurement value of the one or more measurement values is less than a rescue monitoring threshold; and
temporarily limit (<NUM>) the variable rate of infusion in response to the rescue condition.