Fluid delivery device

Abstract

A fluid delivery device includes a pump and a controller. The pump includes a fluid chamber, a drive mechanism, and an interface. The drive mechanism is configured to control movement of a specified volume of fluid relative to the fluid chamber during a fluid movement operation. The interface includes at least one or more components in the drive mechanism that do not move the fluid during a portion of the fluid movement operation. A controller is configured to generate measurement data indicative of fluid movement in the pump during a fluid movement operation. Wherein the drive mechanism is configured not to move the fluid relative to the fluid chamber during at least a portion of a fluid movement operation to draw the fluid and a fluid movement operation to dispense the fluid.

Description

Technical Field

[0001] The present disclosure and technical solutions described herein generally relate to fluid delivery devices. Background Art

[0002] Current sensing is a method of detecting an obstruction in the fluid path of a fluid delivery device such as an infusion pump, because an obstruction results in a reduction in flow, which results in an increase in pressure. Increased pressure results in an increased torque demand on the pump motor, and the increased torque demand of the motor results in a greater current. Other motor parameters besides motor current, such as motor voltage and encoder counts, can also be used to detect increased pressure.

[0003] However, many other design factors affect the current demand of the motor as well as other motor parameters, including but not limited to gearbox efficiency, pump seals and their wear over time, motor efficiency, and motor magnetic angle. In addition, there are environmental factors that can affect the motor current demand, such as ambient pressure and temperature. These factors may negatively affect the accuracy of using measured pump motor parameters such as motor current to detect blockage. Utility Model Content

[0004] The foregoing and other problems are overcome, and additional advantages are achieved, by the illustrative embodiments.

[0005] According to aspects of an illustrative embodiment, a fluid delivery device is provided, the fluid delivery device comprising: a pump, the pump comprising a fluid chamber, a drive mechanism and an interface, the drive mechanism being configured to control movement of a specified volume of fluid relative to the fluid chamber during a fluid movement operation, the interface comprising at least one or more components in the drive mechanism that do not move fluid during a portion of the fluid movement operation; and a controller, the controller being configured to generate measurement data indicating fluid movement in the pump during the fluid movement operation, the measurement data comprising: unloaded measurement data obtained during a portion of the fluid movement operation, during which the pump does not move fluid; and loaded measurement data obtained during the fluid movement operation when the pump moves fluid, the controller being further configured to normalize the loaded measurement data to the unloaded measurement data. measurement data; wherein the pump is a rotary metering pump, the pump includes an inlet port and an outlet port, and wherein the drive mechanism is connected to the pump motor through a gear box, and the fluid chamber has at least one hole, the drive mechanism is operable to selectively drive the piston to dispense fluid from the fluid chamber or to draw fluid into the fluid chamber, and control the cooperation between the at least one hole and the inlet port during a fluid movement operation of drawing fluid, and control the cooperation between the at least one hole and the outlet port during a fluid movement operation of dispensing fluid, the interface includes a feature located on the drive mechanism, the feature being configured to cooperate with the gear box so that the drive mechanism does not move fluid relative to the fluid chamber during at least a portion of the fluid movement operation of drawing fluid and the fluid movement operation of dispensing fluid.

[0006] According to aspects of the illustrative embodiment, the interface includes: a pin on the piston, the piston being controllably inserted and retracted in the sleeve; and a spiral groove in the sleeve, the drive mechanism being operable to rotate the sleeve to control the volume of fluid in the fluid chamber via the spiral groove in the sleeve, wherein the spiral groove in the sleeve guides the pin to be displaced along the spiral groove to guide the retraction and insertion of the piston in the sleeve to control the volume of fluid in the fluid chamber, the pin and / or the spiral groove being configured so that the piston does not move fluid relative to the fluid chamber during at least a portion of a fluid movement operation.

[0007] According to aspects of the illustrative embodiment, the interface includes a cam and a cam follower, the cam being coupled to the drive mechanism and the cam follower being coupled to an actuator for the drive mechanism, the cam follower spanning at least a portion of a flat portion of the cam such that no fluid movement occurs during a fluid movement operation.

[0008] According to aspects of an illustrative embodiment, a fluid delivery device is provided, the fluid delivery device comprising: a pump, the pump comprising a fluid chamber, a drive mechanism and an interface, the drive mechanism being configured to control the movement of a specified volume of fluid relative to the fluid chamber during a fluid movement operation, the interface comprising at least one or more components in the drive mechanism that do not move the fluid during a portion of the fluid movement operation; and a controller, the controller being configured to generate measurement data indicating fluid movement in the pump during the fluid movement operation, the measurement data comprising: unloaded measurement data obtained during a portion of the fluid movement operation, during which the pump does not move the fluid; loaded measurement data obtained during the fluid movement operation when the pump moves the fluid, the controller being further configured to normalize the loaded measurement data to the unloaded measurement data; wherein the pump is a syringe-type pump, the pump comprising a barrel as the fluid chamber, and the interface comprising a plunger, the drive mechanism being operable to selectively drive the plunger to dispense fluid from the barrel, and to temporarily retract the plunger a nominal amount in the barrel to configure the interface during the fluid movement operation of dispensing the fluid.

[0009] According to aspects of the illustrative embodiment, the interface includes a pusher coupled to the drive mechanism, the drive mechanism operable to selectively drive the pusher against the plunger to dispense fluid from the cartridge and temporarily retract the pusher within the cartridge to configure the interface.

[0010] According to aspects of an illustrative embodiment, a fluid delivery device is provided, comprising: a pump comprising a fluid chamber and a drive mechanism, the drive mechanism being configured to control movement of a specified volume of fluid relative to the fluid chamber during a fluid movement operation; and a controller being configured to generate measurement data indicating fluid movement in the pump during the fluid movement operation, the measurement data comprising unloaded measurement data obtained during a portion of the fluid movement operation (in which the pump does not move fluid), and loaded measurement data obtained during the fluid movement operation in which the pump moves fluid, and the controller being configured to normalize the loaded measurement data to the unloaded measurement data.

[0011] According to aspects of the illustrative embodiment, the controller is further configured to analyze the normalized loaded measurement data to determine whether it meets a specified metric related to pressure in the infusion set indicative of an occlusion.

[0012] According to aspects of the illustrative embodiment, the controller is further configured to: during a subsequent fluid movement operation of the pump, generate unloaded measurement data during a portion of the subsequent fluid movement operation in which the pump does not move fluid, generate loaded measurement data during the subsequent fluid movement operation in which the pump moves fluid, and normalize the loaded measurement data to the unloaded measurement data, wherein the measurement data is indicative of fluid movement in the pump.

[0013] According to aspects of the illustrative embodiments, the fluid movement operation is an incremental operation of a plurality of fluid movement operations to dispense fluid from the chamber or to draw fluid into the chamber.

[0014] According to aspects of the illustrative embodiment, the controller is further configured to normalize the loaded measurement data to the unloaded measurement data for each fluid movement operation of the fluid delivery device, or at least for a selected subset of fluid movement operations of the fluid delivery device.

[0015] According to aspects of the illustrative embodiments, the fluid delivery operation is selected from a pumping operation to draw fluid into the chamber and a dispensing operation to expel fluid from the chamber.

[0016] According to aspects of the illustrative embodiments, the measurement data is indicative of a fluid property selected from the group consisting of fluid pressure and fluid flow rate.

[0017] According to aspects of the illustrative embodiment, the pump is a syringe-type pump having a barrel and a plunger as a chamber, and the drive mechanism is operable to selectively drive the plunger to dispense fluid from the barrel, and the controller is configured to generate unloaded measurement data during a fluid movement operation before the measurement data indicates that the fluid pressure or flow rate has increased due to the drive mechanism driving the plunger.

[0018] According to aspects of the illustrative embodiments, a pump is characterized by an interface that includes at least one or more components in a drive mechanism, and operation of the at least one or more components causes a portion of a fluid moving operation to occur in which the pump does not move the fluid.

[0019] According to aspects of the illustrative embodiments, the pump can be a syringe-type pump having a barrel as a chamber, and the interface includes a plunger, the drive mechanism is operable to selectively drive the plunger to dispense fluid from the barrel, and the controller is configured to generate unloaded measurement data by temporarily retracting the plunger a nominal amount in the barrel during a fluid movement operation to dispense the fluid.

[0020] According to aspects of the illustrative embodiments, the pump can be a syringe-type pump having a barrel as a chamber, and the interface includes a plunger, the drive mechanism is operable to selectively drive the plunger to dispense fluid from the barrel, and the controller is configured to generate unloaded measurement data by manually or externally controlled filling of the barrel via an inlet port to the barrel during a fluid movement operation of aspirating fluid, and to generate loaded measurement data by controlling the pump to temporarily retract the plunger into the barrel during a fluid movement operation of aspirating fluid.

[0021] According to aspects of the illustrative embodiments, the pump can be a syringe-type pump having a barrel as a chamber and a plunger, the interface includes a pusher connected to a drive mechanism, the drive mechanism is operable to selectively drive the pusher to abut the plunger to dispense fluid from the barrel, and the controller is configured to generate unloaded measurement data by temporarily retracting the pusher in the barrel during a fluid movement operation to dispense the fluid.

[0022] According to aspects of the illustrative embodiments, the pump can be a syringe-type pump having a barrel and a plunger as a chamber, the interface includes a pusher connected to a drive mechanism, the drive mechanism is operable to selectively drive the pusher to abut the plunger to dispense fluid from the barrel, and the controller is configured to generate unloaded measurement data by incrementally performing a known number of dispense cycles in which the pusher has not yet struck the plunger before collecting loaded measurement data.

[0023] According to aspects of the illustrative embodiments, the pump can be a rotary metering type pump comprising an inlet port and an outlet port, and wherein a drive mechanism is connected to a pump motor via a gearbox, and a chamber has at least one hole, the drive mechanism being operable to selectively drive a piston to dispense fluid from the chamber or to draw fluid into the chamber, and to control the at least one hole to cooperate with the inlet port during a fluid movement operation of drawing fluid and with the outlet port during a fluid movement operation of dispensing fluid, the interface comprising a feature on the drive mechanism configured to cooperate with the gearbox so that the drive mechanism is able to not move fluid relative to the chamber during at least a portion of the fluid movement operation of drawing fluid and the fluid movement operation of dispensing fluid.

[0024] According to aspects of the illustrative embodiment, the pump can be a rotary metering pump, and the interface includes a pin on the piston and a spiral groove in the sleeve, the pin can be inserted and retracted in the sleeve in a controllable manner, and the drive mechanism can be operated to rotate the sleeve to control the fluid volume in the chamber via the spiral groove in the sleeve, wherein the spiral groove in the sleeve guides the pin to be displaced along the spiral groove to guide the retraction and insertion of the piston in the sleeve to control the fluid volume of the chamber, and the pin and / or the spiral groove are configured so that the piston does not move fluid relative to the fluid chamber during at least a portion of the fluid movement operation.

[0025] According to aspects of the illustrative embodiment, the interface includes a cam coupled to a drive mechanism, and the controller is configured to generate unloaded measurement data during a fluid movement operation when a cam follower coupled to an actuator for the drive mechanism crosses at least a portion of a flat portion of the cam thereby not causing fluid movement during the fluid movement operation.

[0026] According to aspects of the illustrative embodiment, a pump has a reservoir as a chamber, a plunger, and a drive mechanism operable to selectively drive the plunger to dispense fluid from the reservoir, and a controller is configured with baseline data associated with a specified waveform of measurement data during a fluid movement operation, the waveform having a dead zone corresponding to when the pressure or rate of fluid driven by the drive mechanism to the plunger has not yet begun to increase, and the controller is configured to analyze the measurement data using the baseline data to determine when unloaded measurement data is generated during the fluid dispensing operation.

[0027] According to aspects of an illustrative embodiment, a fluid delivery device is provided, characterized in that the fluid delivery device includes: a pump, the pump including a fluid chamber, a drive mechanism and an interface, the drive mechanism being configured to control the movement of a specified volume of fluid relative to the fluid chamber during a fluid movement operation, the interface including at least one or more components in the drive mechanism that do not move the fluid during a portion of the fluid movement operation; and a controller, the controller being arranged on an electrical module supported by a substrate of the fluid delivery device; wherein the pump is a rotary metering type pump, the pump including an inlet port and an outlet port, and wherein the drive mechanism is connected to a pump motor through a gearbox, and the fluid chamber has at least one aperture, the drive mechanism being operable to selectively drive a piston to dispense fluid from or draw fluid into the fluid chamber, and controlling the engagement between the at least one hole and the inlet port during a fluid movement operation of pumping fluid, and controlling the engagement between the at least one hole and the outlet port during a fluid movement operation of dispensing fluid, the interface comprising a feature on the drive mechanism, the feature configured to engage with the gear box so that the drive mechanism does not move fluid relative to the fluid chamber during at least a portion of the fluid movement operation of pumping fluid and the fluid movement operation of dispensing fluid, wherein the rotary metering pump comprises a pump assembly to rotate a sleeve in a pump manifold, and the rotary metering pump further comprises a sleeve rotation limit switch having an interlocking device and one or more stops on the sleeve that engage with the interlocking device, the interlocking device being configured to prevent the sleeve from rotating until the torque exceeds a predetermined threshold.

[0028] Additional and / or other aspects and advantages of the illustrative embodiments will be set forth in the following description, or will be apparent from the description, or may be learned by practicing the illustrative embodiments. The illustrative embodiments may include an apparatus having one or more of the above-described aspects and / or one or more features and combinations thereof, and methods for operating the apparatus. Exemplary embodiments may include one or more features and / or combinations of the above-described aspects such as described in the appended claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] The above and / or other aspects and advantages of the illustrative embodiments will be more readily understood from the following detailed description taken in conjunction with the accompanying drawings, in which:

[0030] Figure 1A and 1B depicts raw and filtered data (e.g., motor current) from an example fluid delivery device during aspiration and dispense strokes, respectively;

[0031] Figure 1C depicts filtered measurement data (e.g., motor current) from an exemplary fluid delivery device during dispensing and changes at different pressures;

[0032] Figure 1D depicts measured data (e.g., motor current) during operation of an exemplary fluid delivery device with and without a drive mechanism component of the fluid delivery device moving fluid to illustrate deadband normalized regions in the data;

[0033] Figure 2 depicts measured data (e.g., motor current) from an exemplary fluid delivery device during a dispense operation and data from regions identified therein for deadband normalization;

[0034] Figure 3 is a flow chart of illustrative operations for performing dead-band normalization of measurement data by an exemplary fluid delivery device performing a dispense operation in accordance with an illustrative embodiment;

[0035] Figure 4 is a perspective view of an exemplary wearable fluid delivery device employing an occlusion detection algorithm with dead zone normalization according to an exemplary embodiment;

[0036] Figure 5A , 5B , 5C and 5D are respectively a partial top view, a perspective view, a side view and a top view of the exemplary fluid delivery device of FIG. 1 with the cover removed;

[0037] Figure 6 is a block diagram of example components of an example fluid delivery device constructed in accordance with an example embodiment;

[0038] Fig. 7A , 7B 7C and 7D are top perspective views of an example fluid delivery device with the cover removed and showing different stages of filling the reservoir;

[0039] Fig. 8A and 8B are front and rear perspective views, respectively, of a plunger driver component constructed in accordance with an example embodiment;

[0040] Fig. 9 yes Figures 7A-7D A side view of an exemplary fluid delivery device of FIG. 1 showing a plunger driver assembly in a retracted position;

[0041] Fig. 10A , 10B , 10C and 10D are Figures 7A-7D a top perspective view of an example fluid delivery device with a cover removed and showing different stages of expelling fluid from a reservoir via a plunger driver assembly;

[0042] Fig.11 is constructed according to an exemplary embodiment for use with Figures 8A-8B A perspective view of a center screw with a keying member engaged with a plunger driver member in FIG.

[0043] Fig.12 and 13 is a partial perspective view of an example pump component in an example fluid delivery device operating according to an occlusion detection algorithm using deadband normalization in accordance with an illustrative embodiment;

[0044] Fig.14A and 14B is an example of a fluid delivery device Fig.12 and 13 A three-dimensional view of a pump component, wherein the pump component is arranged according to a ready-to-dispense operation phase and a ready-to-suction operation phase;

[0045] Fig. 14C Yes Fig.12 and 13 a perspective view of components of an example fluid delivery device of an example pump component and associated electronic circuitry on a printed circuit board;

[0046] Fig.14D is constructed with Fig.12 and 13 A partial perspective view of an exemplary motor and gearbox assembly in cooperation with a pump component;

[0047] Fig.15A is a block diagram of components in an exemplary fluid delivery device; and

[0048] Fig. 15Bis a schematic diagram of a fluid delivery device pump motor with a current sensor in accordance with an illustrative embodiment.

[0049] Throughout the drawings, the same drawing reference numerals will be understood to refer to the same elements, features, and structures. DETAILED DESCRIPTION

[0050] As will be appreciated by those skilled in the art, there are many ways to implement examples, improvements and arrangements of the fluid delivery device according to the embodiments disclosed herein. Although reference will be made to the illustrative embodiments depicted in the accompanying drawings and the following description, the embodiments disclosed herein are not meant to exhaustively list the various alternative designs and embodiments included in the disclosed technical solutions, and those skilled in the art will readily appreciate that various modifications may be made without departing from the scope of the disclosed technical solutions, and various combinations may be made.

[0051] The example embodiments of the present disclosure provide technical solutions to the above-mentioned problems. Due to the above-mentioned design and environmental factors that affect the demand on the pump motor, it is extremely important to adjust or calibrate the pump motor signal used to detect occlusion in a fluid delivery device such as an infusion pump so that only the changes in the motor signal caused by pressure changes are measured and used for occlusion detection, rather than factors unrelated to pressure, such as changes in the battery over time, wear of the motor and gearbox, changes in ambient temperature, differences in pump performance during aspiration operations and dispensing operations, etc. Ideal normalization compensates for everything except pressure, and the example embodiments and technical solutions provided herein advantageously approach ideal normalization.

[0052] The technical solutions and exemplary embodiments provided by the present utility model adopt dead zone normalization; that is, the measurement data related to the fluid movement operation controlled by the drive mechanism in the fluid delivery device is adjusted or standardized to the data obtained during the dead zone of the operation when the drive mechanism does not move the fluid. The technical solutions and exemplary embodiments provided in the present disclosure advantageously adopt dead zone normalization to improve the accuracy of detecting blockage or other conditions by using standardized measurement data. The measurement data can be, for example, the motor current during the fluid dispensing or suction operation. As used herein, "loaded" measurement data refers to measurement data obtained when the drive mechanism moves the fluid during the fluid movement operation, and "unloaded" measurement data refers to measurement data obtained when the drive mechanism does not move the fluid during the dead zone of the fluid movement operation. Dead zone normalization is understood to mean that during a specific fluid movement operation in the fluid delivery device, the loaded measurement data is adjusted or standardized to unloaded measurement data. As used herein, "performing dead-band normalization" and "dead-band normalization" are advantageous because they remove unwanted signal noise components and / or the effects of undesirable variables associated with a drive mechanism in a fluid delivery device (e.g., a pump motor in a drug infusion device) from the measurement data. Removing unwanted signal noise or the undesirable effects of noise factors (e.g., motor design or environmental factors) from the measurement data can involve, for example, subtracting averaged unloaded measurement data from loaded measurement data obtained when the pump motor is operated to move fluid. In addition to subtraction, dead-band normalization can also involve other mathematical adjustments or calibration operations to normalize the measured loaded pump motor data to measured unloaded pump motor data, such as dividing the averaged loaded measurement signal by the averaged unloaded measurement signal.

[0053] Although there are different options for normalizing measurement data, such as pump motor current in a fluid delivery device, as shown in the exemplary embodiment described below, dead-band normalization of the dead-band region of the measurement data achieves significant advantages in terms of the accuracy of detecting a selected delivery device state based on the measurement data. For example, one way to normalize the pump motor data may be to normalize the measurement data obtained during a dispensing operation of the pump to data obtained during a previous suction operation, because the suction operation is not affected by downstream pressure. However, the suction operation is affected by factors different from the dispensing operation, such as upstream pressure, reservoir fill volume, and other noise factors that unevenly affect the suction and dispensing operations. For example, normalizing the measured pump motor data to the suction operation of the pump actually doubles the noise in the measured signal and introduces noise factors that are not present in the dead-band normalization provided by the technical solution described in the present disclosure.

[0054] Various factors that affect the motor current are, for example, motor winding resistance, applied voltage (which changes with battery life, for example), and motor speed. In addition, the current during a dispensing or aspiration operation may be affected by factors such as gear train losses, motor friction losses, and drive mechanism (e.g., piston) friction losses. An advantage of the technical solution described herein is that, according to the technical solution described herein and its exemplary embodiments, the desired factor (i.e., pressure P during a puffing operation) can be obtained by removing all other constants and factors related to friction losses and battery variations using deadband normalization. A Or assign operation P D pressure during the period).

[0055] The present disclosure relates to performing dead-band normalization by normalizing loaded measurement data associated with fluid movement (e.g., pump motor current measured during a fluid dispensing or aspiration operation when a fluid drive mechanism component is controlled to move fluid) to unloaded measurement data obtained when the drive mechanism component is not moving fluid during a dispensing or aspiration operation, and to using dead-band normalization to detect blockages.

[0056] For example, see Figure 1A and 1B , which respectively describe raw and filtered pump measurement data (e.g., motor current) from an exemplary fluid delivery device during aspiration and dispense operations. Figure 1C Filtered pump measurement data from an exemplary fluid delivery device indicating motor current during dispensing and changes at different pressures are depicted; however, all depicted measured current signals share a relatively similar waveform shape, including a first spike 102 corresponding to motor activation, a portion 104 corresponding to the shape of the piston movement, followed by a portion 106 corresponding to a valve state change and a portion 107 in conjunction with the following. Figure 12-15B An interlocking torque spike 108 associated with a rotary metering type pump is described.

[0057] During a dispense operation, dead-band normalization of a measured pump motor signal (e.g., a motor current signal) includes obtaining the current signal when the motor gearbox is rotating but the pump is not engaged. For example, see Figure 1D, where two superimposed current signal waveforms are shown. For example, one of the waveforms 112 is obtained during a dispensing operation of a rotary metering pump and includes a motor start spike 102, a piston moving portion 104, a valve state change 106, and an interlock torque spike 108). The other waveform 110 is obtained during motor operation without a pump (e.g., the motor is disengaged from the pump drive mechanism). Both waveforms have similar portions 100 corresponding to deadband regions that can be identified, and data obtained therein during dispensing operations can be used for deadband normalization of measured pump motor data obtained during motor and pump operation to more accurately detect occlusion conditions by reducing noise and removing undesirable variability in factors affecting the motor. Dead-band normalization of this portion of the signal is good because: (1) this portion of the measured pump motor parameter signal is closer in time to the portion of the measured signal of interest (e.g., measuring current during piston motion to determine pressure changes that can indicate occlusion), which inherently reduces noise because noise factors vary over time; and (2) variations in the battery, motor, and gearbox are dead-band normalized by the analytical signal because the analytical signal is essentially the same as the signals from those components themselves. Noise factors are understood to represent factors that introduce variability internal or external to the fluid delivery device system or subsystem or portion thereof, such as temperature, humidity, component-to-component variations, component wear, etc.

[0058] It should be understood that the dead zone area 100, or the timing used to obtain the dead zone normalization data during a dispensing or aspiration operation, may vary depending on the type of pump and pump drive mechanism. Figure 4-11 The syringe pump explained can be operated at any time during a dispensing operation to temporarily disengage the pump drive mechanism (e.g., reverse its direction so that it does not push the plunger in the syringe reservoir to dispense fluid) to obtain unloaded measurement data while not moving fluid during the dispensing operation. This unloaded measurement data is in turn used to dead-band normalize the pump motor data of the loaded measurement obtained during the pump engagement that causes the fluid to be dispensed. For syringe pumps that are manually filled (e.g., via a supply syringe connected to the inlet port of the pump's syringe reservoir), the motor can be controlled to perform a controlled aspiration operation in which controlled retraction of the pump piston pulls back the plunger in the syringe reservoir to controllably draw more fluid from the supply reservoir into the fluid chamber of the syringe reservoir to obtain loaded measurement data while moving the fluid. This loaded measurement data during the controlled aspiration motion can be dead-band normalized to the unloaded measurement data obtained during manual filling when the drive mechanism is not operated to move fluid. Alternatively, for a syringe pump as described below in combination with Figure 12-15B As explained above for the rotary metering pump, the dead zone region 100 may occur in conjunction with Figure 1B , 1Dand the beginning of each suction stroke and each dispensing stroke described in 2.

[0059] In order to optimize the use of dead zone standardization according to the technical solution provided in this article, the fluid delivery device has an interface as close as possible to its fluid drive interface, which can be moved without moving the fluid. Figure 7A-7B As described, in the case of a syringe-type pump, the interface can be a plunger driver component, such as a pusher 216 constructed on the end of the drive mechanism, which can abut the reservoir plunger 168 after the reservoir 162 is filled and is controlled to push the plunger 168 toward the distal end of the reservoir to dispense fluid therefrom. For dead zone normalization, the pusher 216 can be driven backward and thereby disengaged from the plunger 168. During the dispensing operation, the pusher 216 can be driven forward again to reengage the plunger 168. By being driven backward, the controller operating according to the dead zone normalization algorithm essentially has all the same effects as the pump motor driving the pusher 216 forward (e.g., to dispense), except for the friction of the plunger 168 and the force generated by the pressure. In the case where a syringe-type pump is configured without a pusher 216 (e.g., its drive mechanism is directly connected to its plunger), the interface can be a plunger that is retracted to a nominal amount during dispensing to obtain unloaded measurement data without causing undesirable reverse fluid flow. As shown below in conjunction with Fig.14D In the case of a rotary metering pump, the interface may be the gap between the output gear of the gearbox and the piston tab, so that when the gearbox changes direction there is a period of time when the piston is not engaged at all (e.g. Figure 2 Thus, the technical solutions described in the present disclosure and exemplary embodiments thereof advantageously employ loose-fit drive train features to obtain and use unloaded data from the deadband region of fluid movement operations and are therefore very different from existing noise reduction methods and efforts to improve the accuracy of pump motor data readings.

[0060] The operations associated with dead zone normalization according to an illustrative embodiment of the technical solution described herein are Figure 3 , and may be implemented, for example, by a controller (e.g., Figure 6 Controller 192 or Fig.15AThe dead zone normalization algorithm is performed by a microcontroller 58 in the pump or other devices that process the measurement data. According to an exemplary embodiment, the controller for the fluid delivery device can be programmed or otherwise configured to obtain "loaded" measurement data when the drive mechanism is being operated for fluid movement (e.g., controlled suction or aspiration, or controlled output or distribution), and standardize it with the dead zone or "unloaded" measurement data obtained when the drive mechanism is being controlled for fluid movement operation but temporarily does not move the fluid. According to an exemplary embodiment, dead zone normalization is performed during the suction operation, the distribution operation, or during these two types of operations. It can be beneficial to perform dead zone normalization during filling and during delivery (e.g., disengagement and reengagement during any part of the entire suction or distribution stroke, depending on the controlled volume intended to be sucked into the fluid chamber or delivered from the fluid chamber). In any case, during the operation or stroke of the same pump suction or distribution, it is best to obtain dead zone normalization data (e.g., unloaded measurement data) and loaded measurement data.

[0061] like Figure 3 As shown in the box 120 of , the pump controller can be configured to measure pump motor data (box 122) related to the fluid movement operation at the beginning of the fluid movement operation (e.g., the operation or stroke of suction, or the operation or stroke of dispensing). According to the advantageous aspects of the exemplary embodiments of the technical solutions described herein, the controller obtains or otherwise generates pump motor data (box 124), and the pump motor data includes unloaded measurement data and loaded measurement data during the fluid movement operation. The controller performs dead zone normalization (box 126) by normalizing the loaded measurement data to the unloaded measurement data corresponding to the fluid movement operation according to the technical solutions described herein. It should be understood that the dead zone normalization can include, for example, subtracting the unloaded measurement data from the measured pump motor data to be able to advantageously determine the fluid pressure or flow rate of the pump during the fluid delivery operation without being affected by signal noise or noise factors (e.g., pump design and environmental factors). The unloaded measurement data can be obtained at any time during the fluid movement operation where the drive mechanism does not move the fluid. During the fluid movement operation in which the drive mechanism is engaged in the moving fluid, the loaded measurement data can be obtained at multiple times. In any case, the loaded and unloaded measurement data obtained for that fluid movement operation need not be used or correlated with a different fluid movement operation (block 130).

[0062] As previously described, the technical solution described herein successfully compensates for many variations in the pump (e.g., design factors of the battery, motor, and gearbox, and environmental factors such as temperature) that are unrelated to variations in fluid pressure or flow or other measured parameters used to detect blockage or other states of the fluid delivery device. Ideal normalization compensates for everything except pressure or flow rate, and the technical solution achieves essentially ideal normalization through dead zone normalization as explained in accordance with the exemplary embodiments of this invention. As explained above with respect to factors affecting motor current, for example, there are many items and forces that ultimately add up to the measured current, and the more of these items or forces that can be standardized, the more accurate the blockage detection using the measured parameters can be. In addition, the dead zone normalization as described herein allows the dead zone normalized blockage detection algorithm to be used to evaluate each fluid movement stroke or operation of the pump without having to look at the changes between multiple strokes. Currently, there is no coverage blockage detection involving current sensing or other measured pump motor parameters in infusion pumps that utilizes the non-driven portion of the fluid movement to better evaluate the fluid pressure or flow rate based on the current or other measured motor parameters.

[0063] Blockages in fluid delivery devices (e.g., drug infusion pumps) may be caused by restricted flow or channel constriction (e.g., catheter compression or tissue obstruction), or by an empty drug container. It is important to measure changes in fluid pressure or flow rate in a fluid delivery device due to blockage or other pump failures for early detection, thereby alleviating possible fluid delivery inaccuracies caused thereby, such as missed dosing. The technical solutions and exemplary embodiments of the present utility model achieve more accurate and faster blockage detection, so that inaccuracies in fluid delivery occur less frequently.

[0064] The measured data indicates pressure or flow rate, and can be, but is not limited to, any of motor current, motor voltage, encoder count, motor drive count, delivery pulse energy, motor drive time, etc. For example, current sensing is generally considered to be a reliable method for detecting blockages in fluid paths for fluid delivery, because motor current can be indirectly related to pressure. As described above, blockages cause a reduction in fluid flow in a fluid delivery device, which causes an increase in pressure. The increase in pressure causes an increase in the torque demand required for the motor to overcome the pressure. The increase in torque demand corresponds to an increase in the current drawn by the motor, which is a way to detect blockages such as conduit blockages, or air in the fluid path, or motor failures.

[0065] Figure 4-11 An example fluid delivery device with an example interface that facilitates deadband normalization according to an example embodiment is shown. As described below, in a syringe-type fluid delivery mechanism, a drive assembly can selectively engage and disengage a plunger to allow operation of a pump without fluid movement, thereby obtaining unloaded measurement data for deadband normalization according to an example embodiment.

[0066] Figure 12-15B Described are exemplary embodiments having Figure 4-11 Another example fluid delivery device with different example interfaces to facilitate dead zone standardization. Figure 12-15B As explained, in a rotary metering type fluid delivery mechanism, according to an exemplary embodiment, a gear box and an output gear coupled to a pump drive mechanism allow the pump to be driven without moving fluid to obtain data in a dead zone region 100 of a suction or dispense operation, thereby obtaining unloaded measurement data for dead zone normalization.

[0067] Figure 4 is a side view of an exemplary wearable fluid delivery device 10 configured to perform improved occlusion detection according to an exemplary embodiment. The fluid delivery device 150 includes a base plate 152, a cover 154, and an insertion mechanism 156 in an undeployed position.

[0068] Figure 5A , 5B , 5C and 5D are Figure 4 150 , wherein the cover 154 is removed. The base plate 152 supports the insertion mechanism 156, the motor 158, the power source (e.g., the battery 160), the electrical module 190, and the reservoir 162 or container for storing the fluid, which will be delivered to the user through the outlet fluid path 164 from the outlet port of the reservoir to the insertion mechanism 156. The reservoir 162 can also have an inlet port connected to a filling port (e.g., set in the base plate 12) through the inlet fluid path 166. The reservoir 162 includes a plunger 168 with a plug assembly. The proximal end of the reservoir 162 is also provided with a plunger driver assembly 170. The plunger driver assembly 170 can have a telescopic, simultaneously counter-rotating sleeve screw 212 and a center screw 214, a gear anchor 174, and a nut 210 that rotates via a gear train 172 connected to the motor 158 and the gear box 184. It should be appreciated that the plunger driver assembly 170 may include various components for advancing and withdrawing the plunger 168 within the reservoir 162 .

[0069] Figure 61 is a block diagram of exemplary components of a fluid delivery device. The cover / housing or housing of the device 150 is indicated at 154, and the device 150 has a skin retention subsystem 180, such as an adhesive pad that connects the device 10 to the user's skin. The fluid delivery device 10 also includes a reservoir 162, an insertion mechanism 156, and a fluid displacement module 182, which may include a motor 158, a motor housing and a gear box 184, a gear train 178, a pump mechanism (e.g., a plunger drive assembly 170), and an outlet path 164. The fluid delivery device also includes electrical components, such as a power source module (e.g., battery 160), and an electrical module 190, which includes a controller 192, a motor driver 194, an optional sensing module 196 for sensing fluid flow conditions (e.g., occlusion), an optional audio driver 198 (e.g., for indicating ongoing administration, insufficient reservoir, occlusion, successful pairing with an external device, or other conditions), and an optional visual driver 200, and an optional wireless driver 202 for wireless communication between the fluid delivery device and an optional remote pump control device 203 (e.g., a smartphone or dedicated controller). As described below, the controller 192 can be programmed or otherwise configured to perform improved occlusion detection of an example embodiment of the technical solution described herein.

[0070] Fig. 7A , 7B , 7C and 7D are perspective top views of the fluid delivery device with the cover removed and show different stages of filling the reservoir 162. The fluid-filled chamber 204 in the reservoir 162 is defined by the distal or front side of the plunger 168, and the plunger is configured to seal the fluid from entering the reservoir portion defined by the proximal or rear side of the plunger so that the plunger driver assembly 170 or the gear anchor 174 do not contact the fluid being delivered from the reservoir.

[0071] exist Fig. 7A In FIG. 1 , there is no fluid in reservoir 162 and plunger 168 is in its most distal position. Figures 7A to 7D The plunger drive assembly 30 is shown fully retracted. The user can insert the needle of the filled syringe 176 into a filling port (not shown) provided on the base plate 152, which has an inlet fluid path 166 from the filling port to the reservoir 162, as shown in FIG. Figure 5D As fluid is delivered from syringe 176 to reservoir 162 via inlet fluid path 166, the volume of the fluid chamber defined by the front surface of plunger 28 in reservoir 162 increases, as shown in FIG. Figure 7B , 7C 7D. The plunger 168 has a stopper assembly 169 to prevent leakage of any fluid held in the fluid chamber portion 204 of the reservoir 162. The stopper assembly 169 may include, for example, an elastomeric material similar to a syringe stopper.

[0072] like Figures 7A to 7B As shown in , the gear anchor 174 has a hole 222 to accommodate the first portion 210a of the nut 210. The hole 222 has threads 224, which are configured to mate with the external threads 212a of the sleeve screw 212. The number of threads 224 can be adjusted to balance torque and motion stability. The number of threads 224 can be increased without negatively affecting the length (i.e., only small changes to the geometry of the drive nut are required). The recessed rear surface 226 is configured to rotatably receive the distal end of the first portion 210a of the nut 210. The gear anchor 174 has a front surface 228 that is formed when the plunger driver assembly 170 is fully retracted and the reservoir is filled (e.g., as shown in FIG. 1 ). Fig.7D ), the front surface may abut the plunger pusher 216, but this is not required, depending on the size of the reservoir 162 and the plunger driver assembly 170.

[0073] Fig. 8A and 8B 2 are respectively a front stereogram and a rear stereogram of the plunger pusher 216. The plunger pusher 216 has a stopper 230 on its rear surface to accommodate the key feature 214b on the center screw 214. The optional protrusion 232 on the front surface of the plunger pusher 216 can hit the rear surface of the plunger 168. The pusher 216 is provided with (one or more) features that allow ventilation together with the cover or plunger driver assembly 170 on the reservoir 162 or selectively. For example, a ventilation feature can be provided along at least a portion of the periphery of the pusher 216, and the ventilation feature can be in the form of a scalloped edge including a notch 216a. When the notch 216a is provided on the periphery of the pusher 216, these features can be arranged to minimize axial translation friction by an offset design, and the tolerance of the edges around some of these features 216a is set to be larger than the tolerance of the remaining notch edges, so as to first contact the internal reservoir barrel surface, thereby preventing rotation. The pusher 216 may also be provided with one or more through holes 216b in the plate-shaped portion of the pusher for ventilation.

[0074] Fig. 9 1 is a side view of the plunger driver assembly 170 in a retracted position relative to the gear anchor 174. Fig. 9 and Fig.11 , the plunger driver assembly 170 includes a nut 210 having teeth on the portion thereof that engages the gear train 172 and the motor 158. The distal end portion 210a of the nut is rotatably received in the gear anchor 174, and the internal threads in the nut 210 engage the external threads 212a of the sleeve screw 212. The internal threads 212b in the cavity of the sleeve screw 212 engage the external threads 214a of the center screw 214. As shown in reference Fig.11As described above, the distal end of the central screw 214 is provided with a key feature 214 b that engages with a stopper 230 on the plunger pusher 216 .

[0075] Fig. 10A , 10B 10C and 10D are perspective top views of the fluid delivery device with the cover removed and showing different stages of discharge of fluid from the reservoir by the plunger driver assembly 170. Fig. 10A In FIG, the plunger driver assembly 170 is in a fully retracted position and the volume of the fluid-filled chamber portion 204 of the reservoir 162 is maximized. Fig. 10A , 10B , 10C and 10D, the nut 210 is rotated by the motor and gear box 158 and the intermediate power transmission gear train 172 through the engagement of its teeth 210b. The internal threads 210b of the nut and the hole threads 224 of the gear anchor 174 cooperate with the external threads 212a of the sleeve screw 212 to advance the sleeve screw 212 through the nut 210 and the gear anchor 174 and into the reservoir 162. At the same time, the rotation of the sleeve screw 212 causes the non-rotational advancement of the center screw 214 keyed to the plunger pusher 216. As a result, as the plunger pusher 216 is advanced distally to abut the plunger 168, the plunger 168 is advanced distally.

[0076] refer to Figure 8B and Fig.11 , the key feature 214b on the center screw 214 and its corresponding stop 230 on the rear surface of the plunger pusher 216 provide an anti-rotation mechanism for the plunger pusher 216 relative to the reservoir 162 when the nut of the plunger driver assembly 170 is rotated by the motor and gear box 158 and the intermediate power transmission gear train 172. The center screw 214 can be provided with a key feature to engage the plunger pusher 216. The key feature can be engaged with a non-circular plunger pusher geometry, thereby preventing rotation by geometry, or can be engaged with an intermediate structure for preventing rotation in a working syringe barrel reservoir 162. For example, the size and / or shape of the distal end of the center screw 214 can be set to engage with a corresponding size and / or shape stop or recess 230 in the plunger pusher 216, which prevents any limited rotation imposed on the center screw 214 by the other components 210 and 212 from causing the plunger pusher 216 to rotate relative to the inner wall of the reservoir 162.

[0077] As described above, the optional protrusion 232 on the front surface of the plunger pusher 216 can impact the rear surface of the plunger 168. According to one aspect of the technical solution, the front surface of the plunger pusher 216 can controllably engage or abut the rear surface of the plunger 168 when the plunger driver assembly 170 is driven by the motor and gear box 158 to advance toward the distal end of the fluid chamber portion 204 (e.g., to dispense fluid from the chamber), and disengage or move away from the rear surface of the plunger 168 when the plunger driver assembly 170 is driven by the motor and gear box 158 to retract toward the gear anchor 174, to provide an interface according to an illustrative embodiment of the technical solution to facilitate dead zone normalization (e.g., to obtain unloaded measurement data, to which loaded measurement data can be normalized). For example, during a dispensing operation, a controlled micro-retraction of the plunger pusher 216 from the plunger 168 allows the deadband normalization to be determined by the controller 192 for comparison and more accurate analysis with measured pump parameters obtained during subsequent dispensing, thereby removing noise and more accurately determining pump motor conditions, such as conduit blockage, air in the fluid path or motor failure, and other fluid delivery device conditions that affect fluid path pressure characteristics. In addition, the controller can be configured to generate unloaded measurement data by incrementally performing a known number of dispensing cycles (in which the pusher has not yet struck the plunger) before collecting any loaded measurement data.

[0078] An exemplary embodiment of the dead zone normalization algorithm is also useful for positive displacement pumps. A positive displacement pump is understood to be a pump that works on the principle of filling a chamber (e.g., with a liquid drug from a reservoir) in one stage and then emptying the fluid from the chamber (e.g., to a delivery device such as a cannula deployed in a patient) in another stage. For example, a reciprocating plunger pump or a rotary metering pump can be used. In either case, the piston or plunger is retracted from the chamber to inhale or extract the drug into the chamber and allow the chamber to be filled with a certain volume of the drug (e.g., from a reservoir or barrel of the drug to an inlet port). The piston or plunger is then reinserted into the chamber to distribute or discharge a certain volume of the drug from the chamber (e.g., via an outlet port) to a fluid path extending between the pump and the cannula in the patient.

[0079] For purposes of illustration, reference is made to an example rotary metering-type pump described in commonly owned WO 2015 / 157174, the contents of which are incorporated herein by reference in their entirety. Fig.15A The illustrative system diagram in can also illustrate Figure 4-11 Exemplary components of pumps and other types of pumps.

[0080] refer to Fig.12 , 13, 14A, 14B, 14C, 14D, 15A and 15B, an exemplary rotary metering infusion pump (e.g., a wearable drug delivery device such as an insulin patch pump) includes a pump assembly 20 that can be connected to a DC motor and gearbox assembly 33 ( Fig.14D ) to rotate the sleeve 24 in the pump manifold 22 ( Fig.14D ). A spiral groove 26 is provided on the sleeve. When the sleeve 24 is rotated in one direction and then in the opposite direction, a coupling pin 28 connected to the piston 30 translates along the spiral groove to guide the retraction and insertion of the piston 30 in the sleeve 24, respectively. The sleeve has an end plug 34. When the piston 30 is retracted after the suction stroke and is thus ready for dispensing (such as Fig.14A ), two seals 32, 36 on the respective ends of the piston and the end plug inside the sleeve 24 define a cavity or chamber 38. Thus, the volume of the chamber 38 varies depending on the extent to which the piston 30 is retracted. When the piston 30 is retracted after the dispensing stroke (as shown in FIG. Fig. 14B When the pump 64 (shown) is fully inserted and the seals 32, 36 are substantially in contact with each other, the volume of the chamber 38 is negligible or substantially zero and is thus ready for aspiration. Two ports 44, 46 are provided relative to the pump manifold 22, including an inlet port 44 and an outlet port 46, through which drugs can be drawn from the pump 64 ( Fig.15A ) storage 70( Fig.15A ) flow, the drug that has been drawn into the chamber 38 (e.g., by retraction of the piston 30 during the aspiration phase of operation) can be dispensed from the chamber 38 through the outlet port, for example, into a cannula 72 ( Fig.15A ) fluid path.

[0081] Continue to refer Fig.12 , 13 14A-14C, the sleeve 24 may be provided with an orifice (not shown) that is aligned with either the outlet port 46 or the inlet port 44 (i.e., depending on the degree of rotation of the sleeve 24, and therefore the degree of translation of the piston 30) to allow the drug in the chamber 38 to flow through the corresponding port in the inlet port 44 and the outlet port 46. A pump measurement device 78 ( Fig.15A), which, for example, has an interlock 42 and one or more stops 40 on the sleeve 24 or its end plug 34 that cooperate with the interlock 42. The interlock 42 can be mounted to the manifold 22 at each end thereof. When the pump 64 is in the first position, the stop 40 at the end face of the sleeve 24 is adjacent to the protrusion 48 of the interlock 42, whereby the side hole in the sleeve 24 is aligned with the inlet port 44 to receive fluid from the reservoir 70 into the chamber 38. Under certain conditions (such as back pressure), the friction between the piston 30 and the sleeve 24 may be sufficient to cause the sleeve 24 to rotate before the piston 30 and the coupling pin 28 reach either end of the spiral groove 26. This can result in an incomplete volume of liquid being pumped per stroke. To prevent this, the interlock 42 prevents the sleeve 24 from rotating until the torque exceeds a predetermined threshold, such as Fig.14A This ensures that the piston 30 rotates completely within the sleeve until the connecting pin reaches the end of the spiral groove 26. Once the connecting pin 28 hits the end of the spiral groove 26, the DC motor and gearbox assembly or other type of pump and valve actuator 66 ( Fig.15A ) further movement increases the torque on the sleeve 24 beyond the threshold, causing the interlock 42 to bend and allowing the stop 40 to pass the bump 48. When the sleeve 24 is rotated so that its side hole is facing the cannula 72 or the outlet port 46, the stop 40 moves past the bump 48 in the interlock 42, as shown in FIG. Fig. 14B Another sleeve feature 41 may be provided to engage an electrical switch (e.g., an end stop switch 90 disposed on a printed circuit board 92 and disposed relative to the sleeve and / or end plug 34 to cooperate with the pump metering device 78, such as Fig. 14C shown).

[0082] The gap between the piston 30 and the output gear 39 of the gearbox (e.g., between the tab 31 on the end of the piston and the notch 35 in the output gear 39) provides a useful interface for deadband normalization because it is close to the fluid drive interface that can move at least temporarily without moving fluid during fluid movement operations. For example, Figure 1D As shown, even when the drive mechanism operates the pump piston 30 in a pump aspiration or dispensing operation to move fluid, the starting point 100 of the new direction after the motor starts is similar to the unloaded measurement data and the loaded measurement data can be normalized to the unloaded measurement data.

[0083] Fig.14DA portion of a manifold 22 having a motor and gearbox 33 that mates with a pump assembly 20 is shown. The motor and gearbox 33 includes an opening 43 that can receive a rotational limit switch. In this way, an output gear 39 within the gearbox housing can approach and engage the curved portion of the limit switch. The motor and gearbox 33 also includes an axial retention snap 37 so that the pump assembly 20 can be snap-fitted to the motor and gearbox 33. The motor and gearbox 33 includes a rotation key 41 located within the pump receiving socket 43 to receive the pump assembly 20 and prevent the pump assembly 20 from rotating relative to the motor and gearbox 33. The output gear 39 includes a notch 35 adapted to receive a tab 31 provided on the piston 30, and when assembled, the tab 31 is received in the notch 35 so that the output gear 39 can transmit torque to the piston 30. As the output gear 39 rotates, the pump piston tab 31 rotates and slides axially in the slot 35 to provide a useful interface with which to obtain unloaded measurements for dead-band normalization of loaded measurements corresponding to when the piston is moving fluid to or from the chamber 38. Metal spring flexures on the motor connection and limit switch are used to make electrical contact with pads on the circuit board 92 during final assembly.

[0084] Alternatively, an interface that can contribute to the standardization of the dead zone in the exemplary rotary metering infusion pump can be designed relative to the spiral groove 26 and the coupling pin 28. During the discharge stroke, the piston 30 rotates in a first rotational direction and is driven via the coupling pin 28 along the spiral path of the spiral groove 26 in the sleeve 24. The pump piston 30 translates away from the gearbox while rotating, thereby discharging the fluid from the pump chamber 38 to the outside of the cannula port 1356. During the discharge stroke, the friction between the port seal and the outer diameter of the sleeve 24 is sufficient to ensure that the sleeve does not rotate during this part of the pump cycle. During the valve state change after the discharge stroke, the coupling pin 28 reaches the far end of the spiral groove 26, and the torque continues to be transmitted to the pump piston 30 from the output gear via the coupling pin 28, and is transmitted to the sleeve 24. The sleeve 24 and the pump piston 30 rotate as a unit without relative axial motion. The side hole on the sleeve 24 moves from the outlet port 46 to the inlet port 44. During the suction stroke, the output gear rotates the pump piston 30, and due to the interaction of the coupling pin 28 within the helical groove 26, the piston translates axially relative to the sleeve 24. The pump piston 30 translates toward the gearbox, pulling fluid from the reservoir into the pump chamber via the inlet port 44. During the valve state change after the suction stroke, the coupling pin 28 reaches the upper end of the helical groove 26, and the pump motor continues to transmit torque, causing the sleeve 24 and piston 30 to rotate together as a unit without relative axial movement, and the side hole of the sleeve 24 moves from alignment with the inlet port 44 to alignment with the outlet port 46. The helical groove 26 and coupling pin 28 can be constructed by extending the groove or otherwise changing the size or slope of the groove to provide dead space (for example, within a fluid moving operation where the drive mechanism components operate but do not move fluid) to provide an interface for dead space standardization. Figure 2 of 100).

[0085] According to another exemplary embodiment, a fluid delivery device may have a drive mechanism that employs one or more cams, which according to the present technical solution may provide a beneficial interface for deadband normalization. For example, the deadband provided by the cam and cam follower may be used to obtain unloaded measurement data for deadband normalization. At certain times during a fluid movement operation, where an actuator having a cam follower is controlled to rotate relative to the cam, the advancement of the cam follower along the flat surface of the cam does not cause an associated gear or other component connected to the cam to be operated to move the fluid during the fluid movement operation.

[0086] Regardless of the type of actuator and drive mechanism employed in a fluid delivery device such as a wearable drug infusion pump, deadband normalization advantageously uses an unloaded region or portion in a positive displacement pump fluid movement operation to obtain unloaded measurement data (e.g., pressure, flow rate, etc.) related to fluid movement, and utilizes the unloaded measurement data to normalize loaded measurement data related to the fluid movement operation. The resulting standardized measurement data is advantageous because the effects of actuator-related signal noise and external noise factors (e.g., environmental factors and component-to-component variations) are removed, thereby allowing more accurate blockage detection using standardized measurement data. Another benefit of deadband normalization according to the technical solutions and exemplary embodiments described herein is that the unloaded and loaded measurement data signals used for deadband normalization are processed very locally, i.e., close to a specific fluid movement event (e.g., a specific suction stroke or dispensing stroke). It should be understood that this local or proximal operation is not limited by any specific operation timing or sequence for obtaining loaded and unloaded measurement data during a specific fluid movement event or operation.

[0087] Those skilled in the art will appreciate that the present disclosure is not limited to its application to the details of the configuration and component arrangement set forth in the above description or shown in the accompanying drawings. The embodiments herein may be other embodiments and may be practiced or executed in various ways. In addition, it should be understood that the wording and terminology used herein are for descriptive purposes and should not be considered as limiting. "Including," "comprising," or "having" and their variations used herein are intended to cover the items listed thereafter and their equivalents and additional items. Unless otherwise limited, the terms "connect," "couple," and "install" and their variations are broadly used herein and include direct and indirect connections, couplings, and installations. In addition, the terms "connect" and "couple," and their variations are not limited to physical or mechanical connections or couplings. In addition, terms such as upper, lower, bottom, and top are relative and are used to help illustrate rather than limit.

[0088] The components of the illustrative apparatus, systems, and methods employed in accordance with the illustrated embodiments may be implemented at least in part in digital electronic circuitry, analog electronic circuitry, or in computer hardware, firmware, software, or a combination thereof. For example, these components may be implemented as a computer program product, such as a computer program, program code, or computer instructions tangibly embodied in an information carrier or machine-readable storage device, for execution by a data processing apparatus, such as a programmable processor, a computer, or multiple computers, or for controlling the operation of the data processing apparatus.

[0089] The computer program can be written in any form of programming language, including compiled or interpreted languages, and can be deployed in any form, including as a stand-alone program or as a module, component, subroutine, or other unit suitable for use in a computing environment. The computer program can be deployed to execute on a single computer or at a single site or distributed across multiple sites and interconnected by a communication network. In addition, the functional programs, codes, and code segments used to complete the illustrative embodiments can be easily interpreted by programmers in the field of the illustrative embodiments as being within the scope of the claims illustrated by the illustrative embodiments. The method steps associated with the illustrative embodiments can be implemented by one or more programmable processors executing computer programs, codes, or instructions to perform functions (e.g., by operating on input data and / or generating output). The method steps can also be performed by dedicated logic circuits, and the devices of the illustrative embodiments can be implemented as dedicated logic circuits, such as FPGAs (field programmable gate arrays) or ASICs (application-specific integrated circuits).

[0090] The various illustrative logical blocks, modules, and circuits described in conjunction with the embodiments disclosed herein may be implemented or executed with a general purpose processor, a digital signal processor (DSP), an ASIC, an FPGA, or other programmable logic device, discrete gate or transistor logic, discrete hardware components, or any combination thereof designed to perform the functions described herein. A general purpose processor may be a microprocessor, but in an alternative, the processor may be any conventional processor, controller, microcontroller, or state machine. The processor may also be implemented as a combination of computing devices, such as a combination of a DSP and a microprocessor, a plurality of microprocessors, one or more microprocessors in combination with a DSP core, or any other such configuration.

[0091] Processors suitable for executing computer programs include, for example, general-purpose microprocessors and special-purpose microprocessors, and any one or more processors of any kind of digital computer. Typically, the processor will receive instructions and data from a read-only memory or a random access memory or both. The basic elements of a computer are a processor for executing instructions and one or more storage devices for storing instructions and data. Typically, a computer will also include one or more large-capacity storage devices for storing data (e.g., magnetic disks, magneto-optical disks, or optical disks), or be operably connected to receive data from one or more large-capacity storage devices for storing data (e.g., magnetic disks, magneto-optical disks, or optical disks) or transfer data to these devices or both. Information carriers suitable for implementing computer program instructions and data include all forms of non-volatile memory, such as semiconductor storage devices, such as electrically programmable read-only memory or ROM (EPROM), electrically erasable programmable ROM (EEPROM), flash memory devices, and data storage disks (e.g., magnetic disks, internal hard disks or removable disks, magneto-optical disks, and CD-ROM and DVD-ROM disks). The processor and memory can be supplemented by or incorporated into a dedicated logic circuit.

[0092] Those skilled in the art will appreciate that any of a variety of different technologies and techniques may be used to represent information and signals. For example, data, instructions, commands, information, signals, bits, symbols, and chips that may be referenced in the above description may be represented by voltage, current, electromagnetic waves, magnetic fields or particles, optical fields or particles, or any combination thereof.

[0093] Those skilled in the art will further understand that the various illustrative logic blocks, modules, circuits and algorithm steps described in conjunction with the embodiments disclosed herein can be implemented as electronic hardware, computer software, or a combination of the two. In order to clearly illustrate this interchangeability of hardware and software, various illustrative components, blocks, modules, circuits and steps have been described above generally according to their functions. Whether this function is implemented as hardware or software depends on the specific application and the design constraints imposed on the entire system. The technician can implement the described functions in different ways for each specific application, but this implementation decision should not be interpreted as causing deviation from the scope of the claims illustrated by the illustrative embodiments. The software module can reside in a random access memory (RAM), flash memory, ROM, EPROM, EEPROM, register, hard disk, removable disk, CD-ROM or any other form of storage medium known in the art. The exemplary storage medium is connected to the processor so that the processor can read information from the storage medium and write information to the storage medium. Alternatively, the storage medium can be integrated with the processor. In other words, the processor and the storage medium can reside in an integrated circuit or be implemented as discrete components.

[0094] Computer-readable non-transitory media include all types of computer-readable media, including magnetic storage media, optical storage media, flash memory media, and solid-state storage media. It should be understood that the software can be installed in a central processing unit (CPU) device and sold with it. Alternatively, the software can be obtained and loaded into the CPU device, including obtaining the software through physical media or distributed systems, including, for example, from a server owned by the software creator or a server that the software creator does not own but uses. For example, the software can be stored on a server for distribution over the Internet.

[0095] The above description and drawings are intended to be examples only and are not intended to limit the illustrative embodiments in any way, except as set forth in the following claims. It is particularly noted that the various technical aspects of the various elements of the various illustrative embodiments that have been described above can be easily combined in a variety of other ways by those skilled in the art, all of which are considered to be within the scope of the claims.

Claims

1. A fluid delivery device, characterized in that: The fluid delivery device comprises: a pump comprising a fluid chamber, a drive mechanism configured to control movement of a specified volume of fluid relative to the fluid chamber during a fluid movement operation, and an interface comprising at least one or more components in the drive mechanism that do not move fluid during a portion of the fluid movement operation; and a controller disposed on an electrical module supported by a substrate of the fluid delivery device; wherein the pump is a rotary metering type pump, the pump includes an inlet port and an outlet port, and wherein the drive mechanism is connected to the pump motor via a gearbox, and the fluid chamber has at least one hole, the drive mechanism is operable to selectively drive the piston to dispense fluid from the fluid chamber or to draw fluid into the fluid chamber, and to control the engagement between the at least one hole and the inlet port during a fluid movement operation of drawing fluid, and to control the engagement between the at least one hole and the outlet port during a fluid movement operation of dispensing fluid, the interface includes a feature on the drive mechanism, the feature being configured to cooperate with the gearbox so that the drive mechanism does not move fluid relative to the fluid chamber during at least a portion of the fluid movement operation of drawing fluid and the fluid movement operation of dispensing fluid, The rotary metering pump includes a pump assembly to rotate a sleeve in a pump manifold, and the rotary metering pump also includes a sleeve rotation limit switch, the sleeve rotation limit switch having an interlocking device and one or more stoppers on the sleeve that cooperate with the interlocking device, the interlocking device being configured to prevent the sleeve from rotating until the torque exceeds a predetermined threshold.

2. The fluid delivery device according to claim 1, characterized in that: The interface includes: a pin on the piston, the piston being controllably inserted and retracted in the sleeve; and a spiral groove in the sleeve, the drive mechanism being operable to rotate the sleeve to control the volume of fluid in the fluid chamber via the spiral groove in the sleeve, wherein the spiral groove in the sleeve guides the pin to move along the spiral groove to guide the retraction and insertion of the piston in the sleeve to control the volume of fluid in the fluid chamber, and the pin and / or the spiral groove are configured so that the piston does not move fluid relative to the fluid chamber during at least a portion of the fluid movement operation.

3. The fluid delivery device according to claim 1, characterized in that: The interface includes a cam coupled to the drive mechanism and a cam follower connected to an actuator for the drive mechanism, the cam follower straddling at least a portion of a flat portion of the cam such that no fluid movement occurs during a fluid movement operation.

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