Systems and methods for motor control in infusion devices

Abstract

A drug delivery motor subsystem can be provided, and includes a microcontroller configured to send digital control signals to a driver circuit, and a motor configured to initiate drug dosing upon receiving a Pulse Width Modulation (PWM) signal from the driver circuit. The driver circuit is configured to increase a duty cycle of the PWM signal from an initial level above zero to a target level during drug administration, and the driver circuit is configured to initiate braking of the motor post-administration of the drug.

Description

SYSTEMS AND METHODS FOR MOTOR CONTROL IN INFUSION DEVICESRELATED APPLICATIONS

[0001] This application claims the benefit of and priority to U.S. Provisional Application No. 63 / 517,452, filed on August 3, 2023, the contents of which is hereby incorporated herein by reference in its entirety.FIELD

[0002] This disclosure relates to processes and systems for motor control in infusion devices, to adjust power application and / or increase dosing accuracy.BACKGROUND

[0003] An external ambulatory infusion pump is a medical device used to deliver medicament into a patient’s body in a controlled manner that is designed to be portable or wearable. There are many different types of infusion pumps, which are used for a variety of purposes and in a variety of environments. Some infusion pumps are capable of delivering medicament in small amounts and may be used to deliver nutrients or medications - such as insulin or other hormones, antibiotics, chemotherapy drugs and pain relievers.

[0004] Insulin pumps are a type of external ambulatory infusion pump that helps diabetic patients keep their blood glucose levels within target ranges based on individual need. Some insulin pumps include various hardware and firmware so that the diabetic patient can, for example, attach the pump to their bodies, carry an amount of insulin within a reservoir for multiple daily use, and precisely deliver appropriate amounts of insulin to the patient continuously and / or on- demand.SUMMARY

[0005] Systems and methods for controlling a motor for use in an infusion device are disclosed.

[0006] A drug delivery motor subsystem can be provided, and includes a microcontroller configured to send digital control signals to a driver circuit, and a motor configured to initiate drug dosing upon receiving a Pulse Width Modulation (PWM) signal from the driver circuit. The driver circuit is configured to increase a duty cycle of the PWM signal from an initial level above zero to a target level during drug administration, and the driver circuit is configured to initiate braking ofthe motor post-administration of the drug.

[0007] In some embodiments, the motor moves from a stationary state, in which the motor is not moving, to the initial level upon receiving a PWM signal from the driver circuit.

[0008] A drug delivery motor subsystem can be provided and includes a microcontroller configured to send digital control signals to a driver circuit, and a motor configured to initiate drug dosing upon receiving a Pulse Width Modulation (PWM) signal from the driver circuit. The driver circuit is configured to increase a duty cycle of the PWM signal from an initial zero level to an initial non- zero level to initiate motion of the motor to a target level during drug administration, and the driver circuit is configured to initiate braking of the motor post-administration of the drug.

[0009] In some embodiments, the motor is a brushed DC motor that is powered by a Quad A battery.

[0010] In some embodiments, the driver circuit is configured to linearly ramp the duty cycle from an initial level of 40% + / - 5% to a target level of 100% + / - 5% over a period of 20ms + / - 5% using a frequency of 20kHz + / - 5%.

[0011] In some embodiments, the driver circuit is an H-bridge driver circuit.

[0012] In some embodiments, the PWM signal is controlled by firmware.

[0013] In some embodiments, the driver circuit is configured to increase the duty cycle of the PWM signal linearly over time from the initial level to the target level.

[0014] In some embodiments, the driver circuit is configured to increase the duty cycle of the PWM signal over time by controlling power supply to the motor across a sequence of iterations, wherein the driver circuit increases the power supply by a set amount in each iteration of the sequence of iterations.

[0015] In some embodiments, the motor is configured to communicate with a drive mechanism, the drive mechanism being configured to dispense the drug from a reservoir within a drug delivery device.

[0016] A disposable infusion pump can be provided and includes a microcontroller, a driver circuit configured to receive digital control signals from the microcontroller, a motor configured to initiate drug dosing upon receiving a Pulse Width Modulation (PWM) signal from the driver circuit, a battery configured to power the motor, a reservoir configured to hold a drug, a plunger moveably disposed in the reservoir, and a leadscrew coupled to the motor, and configured to be actuated by the motor to move the plunger linearly along the reservoir to enableadministration of the drug from the reservoir to a patient. The driver circuit is electrically connected to the battery and is configured to increase a duty cycle of a Pulse Width Modulation (PWM) signal from an initial level above zero to a target level during drug administration. The driver circuit is configured to initiate braking of the motor post-administration of the drug.

[0017] In some embodiments, the techniques described herein relate to a disposable infusion pump, wherein the motor is a brushed DC motor that is powered by a Quad A battery.

[0018] In some embodiments, the techniques described herein relate to a disposable infusion pump, the driver circuit is configured to linearly ramp a duty cycle from an initial level of 40% + / - 5% to a target level of 100% + / - 5% over a period of 20ms + / - 5% using a frequency of 20kHz + / - 5%.

[0019] In some embodiments, the techniques described herein relate to a disposable infusion pump, wherein the driver circuit is an H-bridge driver circuit.

[0020] In some embodiments, the techniques described herein relate to a disposable infusion pump, wherein the PWM signal is controlled by firmware.

[0021] In some embodiments, the techniques described herein relate to a disposable infusion pump, wherein the driver circuit is configured to -increase the duty cycle of the PWM signal linearly over time from the initial level to the target level.

[0022] In some embodiments, the techniques described herein relate to a disposable infusion pump, wherein the driver circuit is configured to increase the duty cycle of the PWM signal over time by controlling power supply to the motor across a sequence of iterations, wherein the driver circuit increases the power supply by a set amount in each iteration of the sequence of iterations.

[0023] A method of controlling a motor can be provided and includes applying, using a driver circuit, a Pulse Width Modulation (PWM) signal to a motor during administration of a drug to a patient, the motor controlling a drive mechanism for dispensing the drug to the patient, increasing, using the driver circuit, a duty cycle of the PWM signal from an initial level above zero to a target level during drug administration, and initiating, using the driver circuit, braking of the motor post-administration of the drug, wherein the initial level of the duty cycle of the PWM signal begins rotation of the motor for administration of the drug.

[0024] In some embodiments, the driver circuit linearly ramps a duty cycle from an initial level of 40% + / - 5% to a target level of 100% + / - 5% over a period of 20ms + / - 5% using afrequency of 20kHz + / - 5%.

[0025] In some embodiments, applying braking includes at least one of regenerative braking, rheostatic or dynamic braking, and plugging or reverse current braking.

[0026] In some embodiments, the driver circuit increases the duty cycle of the PWM signal linearly over time from the initial level to the target level.

[0027] In some embodiments, the driver circuit increases the duty cycle of the PWM signal over time by controlling power supply to the motor across a sequence of iterations, wherein the driver circuit increases the power supply by a set amount in each iteration of the sequence of iterations.

[0028] In some embodiments, the motor is a brushed DC motor that is powered by a Quad A battery. In some embodiments, the driver circuit is an H-bridge driver circuit. In some embodiments the PWM signal is controlled by firmware.BRIEF DESCRIPTION OF THE DRAWINGS

[0029] A better understanding of the features of the present disclosure will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the disclosure are utilized, and the accompanying drawings of which:

[0030] FIG. 1 is a perspective view of an example infusion delivery system that includes an infusion delivery device (IDD) and a remote controller device;

[0031] FIG. 2A is an exemplary embodiment of a perspective view of an exemplary embodiment of an IDD;

[0032] FIG. 2B is an exploded view of an exemplary embodiment of an IDD;

[0033] FIG. 3 is a bottom view of an exemplary embodiment of an IDD;

[0034] FIG. 4 is an exploded view of an exemplary embodiment of an IDD showing exemplary internal subsystems;

[0035] FIG. 5 is an exemplary block diagram illustrating connections between various subsubsystem architectures of an exemplary embodiment of an IDD;

[0036] FIG. 6A is a top perspective view of an exemplary embodiment of an IDD with the cover removed and constructed in accordance with an exemplary embodiment of the present disclosure;

[0037] FIG. 6B is a top view of an exemplary embodiment of an IDD in accordance withan exemplary embodiment of the present disclosure;

[0038] FIG. 6C is an end view of an exemplary embodiment of an IDD in accordance with an exemplary embodiment of the present disclosure;

[0039] FIG. 6D is a perspective top view of a fluid delivery device showing a first stage of discharging fluid from a reservoir of an IDD;

[0040] FIG. 6E is a perspective top view of a fluid delivery device showing a second stage of discharging fluid from a reservoir of an IDD;

[0041] FIG. 7 is a flowchart showing an exemplary method for ramping up a voltage to a target voltage for running a motor of an exemplary embodiment of an IDD;

[0042] FIG. 8 is a flowchart showing an exemplary method for braking a motor of an exemplary embodiment IDD;

[0043] FIG. 9 is an exemplary embodiment of a circuit for controlling a motor of an IDD; and

[0044] FIG. 10 is a block diagram of an exemplary computer system.

[0045] While the above-identified drawings set forth presently disclosed embodiments, other embodiments are also contemplated, as noted in the discussion. This disclosure presents illustrative embodiments by way of representation and not limitation. Numerous other modifications and embodiments can be devised by those skilled in the art which fall within the scope and spirit of the principles of the presently disclosed embodiments.DETAILED DESCRIPTION

[0046] Some systems and methods described herein relate to motor control of an infusion delivery device (IDD), for example, to control power application to a motor to regulate motor inrush current and battery voltage dropout that could otherwise occur due to current spikes, and / or to increase accuracy of dosing of a drug supplied by the IDD.

[0047] When using a medical device, such as an IDD, it can be advantageous to ensure adequate power supply to the device, for example, to ensure delivery of medication or other substances to a patient. Particularly in the cases of application of medicines that are critical or important to health, if a device is battery powered, it is important to ensure that the battery has sufficient capacity beyond a necessary lifespan. This can counsel a designer of a medical device toward large capacity batteries. Some medical devices, however, are designed to be disposable andto have a short lifespan, which can encourage designing the devices with low cost. Some medical devices may also be designed to be unobtrusive for a user, being of low weight and small size. Part of that low cost and / or small size / weight can be achieved with a lower-capacity battery. There can, therefore, be a tension in design of medical devices when it comes to battery capacity. Erring on the side of battery capacity can lead to devices that are often larger and higher cost than desired.

[0048] The inventors have recognized and appreciated that a device with lower battery capacity (and, thus, potentially lower cost and / or smaller size) may be achieved if the electronics of the device draw power from the battery in a regulated way that may extend life of the battery. More particularly, the inventors have recognized and appreciated that for medical devices that include motors, like IDDs, a current spike can often occur when initiating movement of the motor. When the motor is engaged many times over the life of the medical device, the current spike each time the motor engages may degrade the life of the battery and may lead to a higher capacity requirement for the battery to ensure sufficient power is available for the life of the device. The inventors recognized and appreciated that regulating the current spike that may arise with the battery can reduce wear and tear on the battery and enable use of a battery of lower capacity than others.

[0049] Accordingly, some embodiments described herein include a driver circuit (or a control circuit) arranged to drive a motor of a medical device by ramping a power applied to the motor from an initial power to a desired target drive power for the motor. In some embodiments, the motor of the medical device may be a motor that communicates with a reservoir plunger to dispense a drug stored in the medical device. The driver circuit may be arranged in various ways to perform the ramping, including in some embodiments by performing pulse width modulation (PWM). For example, the driver circuit may adjust the current applied to the motor from an initial duty cycle to a target duty cycle across a ramp-up period. The initial duty cycle may, in some embodiments, be chosen to be a duty cycle that provides an average voltage across the cycle that equals or exceeds a threshold voltage to move the motor. In some embodiments, the driver circuit may be a circuit (e.g., controller, processor) that executes instructions, and the instructions may be in the form of firmware or software that controls the PWM.

[0050] The inventors have additionally recognized and appreciated that conventional medical devices that supply a drug to a patient may suffer from inadvertent over-dosing of a patient, as a motor may move to supply the drug to the patient and then, at the end of a cycle ofapplying the drug, the motor may additionally spin until friction stops it. The additional spins of the motor may lead to inadvertent overdosing of the patient with the drug, which may be a small amount in some cases but that may add up over time. The inventors recognized and appreciated that rather than allowing a motor to spin at the end of a dosage cycle, accuracy of dosing could be improved by braking the motor such that it stops spinning at a time.

[0051] Described herein are various embodiments of electronics for control of a motor of a medical device such as an IDD. It should be appreciated that embodiments are not limited to operating in accordance with any of the examples below, as other embodiments are possible.

[0052] The example embodiments of the present disclosure are described with reference to an example infusion delivery device, such as an IDD 10, as shown in FIG. 1. The IDD 10 can be any type of medical device configured to deliver any type of medicament or other fluid to the patient. In some embodiments, the medicament can comprise insulin or other pharmaceutical or therapeutic drugs. In some embodiments, the IDD 10 is a wearable infusion pump. In some embodiments, the IDD 10 is an insulin patch pump. The IDD 10 can be programmable and / or can be optionally controlled by a remote controller 11, such as a mobile phone, dedicated remote wireless controller (WC), or other control device. In some embodiments, the IDD 10 can be capable of wirelessly communicating with the remote controller 11. In some embodiments, the IDD 10 can include a wired controller rather than communicating with a controller remotely.

[0053] FIG. 2A provides a perspective view of a wearable, fully disposable IDD 10 depicted in accordance with an example embodiment of the present disclosure. In some embodiments, the IDD 10 is an insulin patch pump. Although described with respect to an insulin patch pump, the IDD 10 can be any other type of wearable or programmable medical device, such as any infusion device, configured to deliver any type of medicament or fluid. In some embodiments, the medicament can comprise insulin or other pharmaceutical or therapeutic drug.

[0054] In some embodiments, as shown in FIGS. 2A and 2B, the IDD 10 includes a housing comprising a top enclosure 12 and a bottom enclosure 14 with a removable adhesive patch 16. The top enclosure 12 includes a hole 23 through a top surface of the top enclosure 12 of the IDD 10 through which a user-accessible and user-actuatable insertion mechanism 22 is configured to extend through, as shown in the exploded view of the IDD 10 in FIG. 2B. The insertion mechanism 22, upon activation, inserts a catheter into the user’s skin to establish a fluid path from a fluid reservoir to the user via the catheter and other components in the fluid path. In someembodiments, the insertion may be vertical or close to perpendicular into the surface of the user’s skin. In some embodiments, the insertion can be automated and not manually actuated by the user. To protect the user from accidentally activating the insertion mechanism 22 prematurely, the IDD 10 can include a removable safety cover 18 over the insertion mechanism. The insertion mechanism of IDD 10 may be similar to an insertion mechanism described in US Patent Application No. 17 / 838,938, which is incorporated herein by reference in its entirety.

[0055] The IDD 10 includes an insertion seal assembly 20, shown in more detail in FIG. 2B, that is positioned opposite the insertion mechanism 22. The insertion seal assembly 20 is positioned on the IDD 10 during the process of filing a reservoir within the IDD 10. In some embodiments, the IDD 10 includes a mechanism to ensure that the insertion seal assembly 20 is present during the filing process. For example, a magnet on the insertion seal assembly 20 can generate a magnetic field for the electrical subsystem to sense the presence of the insertion seal assembly 20 while the user is setting up the device. The signal is later used by firmware to mitigate risk of running fill detection and / or priming while the user wears the IDD 10. The insertion seal assembly 20 includes an insertion tab 201, an insertion tubing 204, a portion of which is retained within a slot that forms a volume used for priming the IDD 10, and a venting member 202. In some embodiments, the venting member 27 is in fluid communication with a reservoir inside the IDD 10. In some embodiments, the venting member 27 is in the form of a hydrophobic vent material which prevents medicament from flowing out of the insertion tubing 25. In some embodiments, the insertion seal assembly 20 is removed by the user after priming, described in more detail below. A slot in the insertion tab 201 includes retaining means. In some embodiments, the distal portion of the insertion tubing 204 is bent so that it is retained within the slot. Retainers keep the insertion tubing 204 within the slot after assembly and enables the insertion tubing 204 to be removed with the insertion tab 201 when the IDD 10 has been primed and deployed. In some embodiments, barbs are used as retainers to keep the insertion tubing 204 within the slot. Any suitable method to retain the insertion tubing 204 within the slot may be used, as will be appreciated. This includes adhesive to attach the insertion tubing 204 to the inside of the slot, heat staking, mechanical lock, or any combination of attachment methods. Additionally, the insertion tubing 204 may be bent or penetrate straight through the insertion tab 201 and be attached to the insertion tab 201 using any suitable attachment method.

[0056] FIG. 3 provides an exemplary embodiment of a bottom view of the IDD 10 depicted in FIG. 2A. As shown in FIG. 3, the adhesive patch 16 includes one or more holes (26, 27) therethrough to expose the bottom enclosure 14 of the IDD 10 to provide access to a fill port 24, to fill the internal reservoir with insulin or any other drug, and an insertion opening 22, respectively. The internal reservoir of the IDD 10 can be filled with a medicament via the fill port 24 spanning through the bottom enclosure 14, an internal bracket assembly 32 within a housing of the IDD 10 (shown in more detail in FIG. 4), and up into an inlet port of the internal reservoir 34. The internal bracket assembly 32 may comprise space for different internal elements of the IDD 10, described in further detail below. The bottom enclosure 14 of the IDD 10 can also include an opening such that a catheter can extend from the bottom surface of the IDD 10 and inserted into the skin of the patient to deliver medicament from the reservoir to the patient, as will be explained in more detail below. The insertion mechanism 22 may protrude through the opening to allow the catheter to be inserted into the user for delivery of medicament to the user. The IDD 10 can further include a power button 30, indicated to a user by a power button indicia 302, which can be depressed by the user when the user is ready to pair with, for example, a WC.

[0057] FIG. 4 provides an exploded view of the IDD 10 of FIG. 2A, illustrating components of the internal subsystems of the IDD 10, while FIG. 6A provides a top perspective view of the IDD 10 with the top enclosure 12 removed. An internal bracket assembly 32 is configured and shaped to hold various sub-systems of the IDD 10 and positioned between the top and bottom enclosures of the IDD 10. The IDD 10 includes a reservoir 34 for carrying medicament, a motor that is equipped with a planetary gearbox gearhead and interfaces with a gear train assembly 36, a battery 38, and a printed circuit board assembly (PCBA) 40, as well as insertion mechanism 22 as previously discussed. The PCBA 40 has communications capabilities to outside devices such as a remote pump control device and computer, including a smart phone or dedicated wireless controller.

[0058] The reservoir 34, the motor 39 and the gearbox, the gear train assembly 36 and the battery 38 are constrained within the housing of the IDD 10 by the internal bracket assembly 32 and top enclosure 12 (on the top half of the reservoir 34) to minimize relative motion of the components during pump operation. The PCBA 40 is disposed between the internal bracket 32 and the bottom enclosure 14.

[0059] FIG. 5 is an exemplary block diagram showing various subsystems of the IDD 10 and how the subsystems integrate with one another. The black arrows indicate an interface or communication between components, which may be one or more of a mechanical interface, a fluid interface, and an electrical interface. As shown, a fluid sub-subsystem 100 is disposed within an enclosure sub-subsystem which includes, but is not limited to, the structure / location / retention / features to support medicament fill, such as insulin or other drugs. A pump sub-subsystem 300 includes, but is not limited to, a motor 39 and the gearbox, geartrain assembly 36, a drive gear 42, a pusher to deliver the medicament (i.e., insulin / drug) to a patient, a primary index high resolution encoder and a backup low resolution encoder.

[0060] An electrical sub-subsystem 500 includes, but is not limited to, the PCBA 40 that houses and electrically interfaces many of the components of the IDD 10 including, but not limited to, integrated circuits (ICs), a motor driver 70, a battery 38, a current sensor 71 (i.e., a sense resistor), a pressure sensor 50, microcontrollers 52 (MCUs) with processor, memory and input / output peripherals, network adapter, index encoder sensor and backup encoder sensor. Some of the functions of the electrical sub-subsystem 500 in conjunction with the firmware of the IDD 10 include, but are not limited to, turning the IDD 10 on / off; recognizing user input; processing data; storing data; managing power supply; sending and receiving data; priming; detecting reservoir volume; detecting occlusion; delivering insulin; and pairing / unpairing to an external device / application via Bluetooth®.

[0061] In some embodiments, there are two microcontrollers 52 in the IDD. In some embodiments, one MCU is a Bluetooth Low Energy microcontroller (“BLE MCU”) that is used to house the main application code to control all inputs and outputs of the IDD. The term “Bluetooth Low Energy (BLE)” refers to a wireless communication protocol that is similar to, but independent of, traditional Bluetooth, that permits devices to communicate over short distances with lower energy. Although BLE is independent of Bluetooth, the two protocols can be supported by a single device and can use a single antenna. In some embodiments, the BLE MCU comprises a processor, a non-transitory computer-readable storage medium storing one or more programs configured for execution by a processor 52 of the IDD 10. A network adapter may be any suitable hardware and / or software to enable the IDD 10 to communicate wired and / or wirelessly with any other suitable computing device over any suitable computing network.

[0062] In some embodiments, a microcontroller of the IDD 10 can communicate with a WC to receive information on basal and bolus dosing rates, deactivation requests and software updates as well as transmit pump health, dosing status, and fault modes. In some embodiments, the electrical sub-subsystem 500 includes, but is not limited to, a BLE chip antenna that is used to provide communication between the BLE MCU and the WC. The pressure sensor 50 input interfaces with the closed end of the reservoir 34 and is connected to the PCBA 40 with a flex cable 63 and connector and communicates to the BLE MCU. In some embodiments, the pressure sensor 50 may be connected to processors 52 via Inter-Integrated Circuit (12 C), a bus interface connection protocol for serial communication.

[0063] In some embodiments, one additional MCU of the IDD 10 is an independent safety microcontroller (“Safety MCU”) that monitors the current sensor, the index encoder, and backup encoder while communicating to the BLE MCU to ensure proper pump operation. The Safety MCU and BLE MCU each have the ability to shut down the motor 39 in the event of a fault condition. A motor driver 70 is used to turn the motor 39 and the gearbox forward. In some embodiments, the motor driver 70 is used to turn the motor 39 and the gearbox forward using a PWM signal, as will be described in more detail below. In some embodiments, the motor 39 and the gearbox is a DC motor. In some embodiments, the DC motor is a DC brushed motor. The motor current is monitored on the high side of the motor with the current sensor 71. This current sensor 71 is used to measure motor current to determine pump performance and infer battery health. In some embodiments, the current sensor 71 is also used to detect motor runaway. In some embodiments, the current sensor 71 is used for occlusion detection.

[0064] FIGS. 6A, 6B, and 6C illustrate a perspective view, a top view, and an end view of the fluid delivery device of FIG. 2A with the top enclosure 12 removed and constructed in accordance with an examplary embodiment. The bottom enclosure 14 supports the insertion mechanism 22, a motor 39, a power source such as a battery 38, a control board such as PCBA 40, and a reservoir 34 or container for storing a fluid to be delivered to a user via an outlet fluid path 124 from an outlet port of reservoir to the insertion mechanism 22. The reservoir 34 can also have an inlet port connected via an inlet fluid path 126 to a fill port (e.g., provided in the bottom enclosure 14). The reservoir 34 contains a plunger 44 having a stopper assembly. The proximal end of the reservoir 34 is also provided with a plunger driver assembly 130 having telescoping,simultaneously counter-rotating sleeve screw 72 and center screw 74, a gear anchor, and a nut 70 that is rotated via a geartrain assembly 36 connected to the motor 39.

[0065] FIG. 6C illustrates an exemplary embodiment of a geartrain assembly 36 cooperating with a magnetic encoder 60. The gear train assembly 36 is illustrated as a compound gear, but one of ordinary skill in the art would readily appreciate that other components can be implemented to translate input rotation of motor 39 to a drive gear 42 and a drive nut (or leadscrew nut) 41 (shown in FIG. 6A). For example, current can be applied to rotate the motor 39 and translate this rotation throughout the gear train assembly 36 to the drive gear 42. The drive nut 41 is advantageously rotated by the drive gear 42. In some embodiments, the drive nut 41 is the rotating component that engages, or can be rotationally coupled with, the leadscrew 35. Rotation of the leadscrew 35 causes linear motion of the plunger 44 and ultimate ejection of the medication from the IDD. In other words, in some embodiments, the drive nut 41 is the mechanically closest rotating component to the plunger 44 whereby detection of rotational motion, or lack thereof, of the drive nut 41 provides a proximate indication of axial displacement, or lack thereof, of plunger 44. In some embodiments, as shown in FIG. 6C, the drive gear 42 is rotationally fixed to the drive nut 41 and engaged with the gear train assembly 36 operated by the motor 39. Further, the drive gear 42 is constrained by the leadscrew 35 and a main frame of the assembly to react to forces from a plunger movement and from fluid pressure.

[0066] The geartrain assembly 36 includes a drivetrain cooperating with a magnetic backup encoder at the end of the drive nut 41 at the drive gear 42. The backup encoder is intended to provide a rotational signal associated with the most distal part of the gear chain, in this case the drive nut component is used to provide safety control systems feedback. Several magnetic fields integrated into the end drive nut interface with a backup encoder sensor, which in some embodiments is a magnetic switch sensor, on the PCBA 40 provide the backup encoder function. Integrating the backup encoder as part of the pump screw assembly also allows it to detect drivetrain failures in the compound gearset, such as those that could lead to under delivery. The drivetrain of the geartrain assembly 36 is illustrated as a compound gear, but one of ordinary skill in the art would readily appreciate that other components can be implemented to translate input rotation of motor 39 to a drive gear 42 and a drive nut (or leadscrew nut) 41. For example, current can be applied to rotate the motor 39 and translate this rotation throughout the drivetrain to the drive gear 42. The drive nut 41 is advantageously rotated by the drive gear 42. In someembodiments, the drive nut 41 is the rotating component that engages, or can be rotationally coupled with, the leadscrew of the pump drive mechanism. Rotation of the leadscrew causes linear motion of the plunger and ultimate ejection of the medication from the IDD. In other words, in some embodiments, the drive nut 41 is the mechanically closest rotating component to the plunger whereby detection of rotational motion, or lack thereof, of the drive nut 41 provides a proximate indication of axial displacement, or lack thereof, of plunger. In some embodiments, the drive gear 42 is rotationally fixed to the drive nut 41 and engaged with the drivetrain of the gear train assembly 36 operated by the motor 39 and the gearbox. Further, the drive gear 42 is constrained by the leadscrew and a main frame of the assembly to react to forces from a plunger movement and from fluid pressure.

[0067] In some embodiments, the motor 39 includes an output shaft 29 that is in line with and directly drives the pump drive mechanism 37 without the use of a gear train assembly 36 in a similar manner as described above. An exemplary motor 39 includes a stepper motor. The stepper motor could be used if the form was different (for example, a narrow reservoir). In other words, there would likely be a significant loss of resolution unless a small pitch of the leadscrew 35 was implemented (difficult to achieve) or a cross section of a reservoir is decreased. A smaller cross section of a reservoir is much easier to achieve especially when delivering a small volume of medication.

[0068] FIGS. 6D and 6E are perspective top views of a fluid delivery device with the top enclosure removed and showing different stages of discharging fluid from a reservoir via the plunger 44 and a plunger drive assembly 130 constructed in accordance with an examplary embodiment. The configuration of the double-acting, telescoping lead screw design of the plunger drive assembly 130 mounted behind the reservoir 34 is beneficial to maximize the available reservoir fluid volume while minimizing the reservoir's overall footprint on the bottom enclosure 14. A rear portion of the sleeve screw 72 extends beyond the nut 70 when the plunger drive assembly 130 is in a full retracted position, but the overall length of the plunger drive assembly 130 when un-deploy ed and therefore the overall footprint of the reservoir 34 and plunger drive assembly 130 is minimized by the double-acting, telescoping lead screw design in accordance with an exemplary embodiment.

[0069] In FIG. 6D, the nut 70 is being rotated by the motor and gearbox 118 and the intermediate power transmission gear train 132 via engagement of its teeth. The inner threads ofthe nut and the aperture threads of the gear anchor 134 cooperate with the outer threads of the sleeve screw 72 to advance the sleeve screw 72 through the nut 70 and the gear anchor 134 and into the reservoir 34. Simultaneously, the rotation of the sleeve screw 72 causes non-rotational advancement of the center screw 74 which is keyed to the plunger pusher 76. As a result, the plunger 44 is advanced distally as plunger pusher 76 is advanced distally to abut the plunger 44. FIG. 6E shows further double-acting extension of the sleeve screw 72 and the center screw 74 at essentially equal lengths as the nut is rotated by the motor and gearbox 118 and the intermediate power transmission gear train 132.

[0070] The IDD 10 includes a primary index high resolution encoder. In some embodiments, the primary index high resolution encoder is an optical encoder that interfaces with a bladed “fan” feature 29a attached to the output shaft 29 of the gearhead attached to the motor 39. A rotational signal associated with the motor and gearbox design element at the closest gear train assembly 36 component is used to provide dosing control system feedback. An index encoder sensor, which in some embodiments is an optical interrupter, is populated on the PCBA 40 that watches the bladed fans / flags connected to the output of the motor gearbox. This allows the microprocessor to count digital signal transitions per revolution of the output gear shaft which helps determine dosage delivery or if a fault occurs. Integrating the index encoder as part of the pump screw assembly also allows it to detect motor failures in the motor and gearbox, such as those that could lead to over or under delivery.

[0071] In some embodiments, the resolution of the magnetic encoder 60 can be measured at any place in the gear train assembly 36 based on the desired tradeoff between the precision of sensor 150 and the required resolution. For example, the resolution can be improved if the sensor 150 in the drivetrain is moved closer to the motor. However, a more precise sensor 150 would be required to achieve the improved resolution. The sensor 150 can be positioned at an output of the gear train assembly 36 where the low resolution encoder is measured. Alternately, the sensor 150 can be positioned at an input end of the gear train assembly 36 where the high-resolution encoder is measured.

[0072] In some embodiments, the gear train assembly 36 could include a belt system, friction gears or other forms of power transmission (as opposed to traditional gears). Friction gears could be advantageous if there are backlash-type problems with traditional gears.

[0073] FIG. 6C further illustrates the printed circuit board 40 with a sensor 150 disposed thereon. The sensor 150 includes a low-resolution magnetic proximity sensor such as a magnetic Hall Effect sensor or a magnetic resistance sensor. Various magnetic Hall Effect sensors 150 can be used to accommodate different magnetic field strengths and / or sensitivities.

[0074] In some embodiments, the sensor 150 can be disposed anywhere in an interior of the IDD, i.e., between the top enclosure 12 and the bottom enclosure 14. In another embodiment, the sensor 150 can be connected by a wire or a flexible circuit, instead of via the printed circuit board 40.

[0075] In some embodiments, sensor 150 can be aligned vertically to an axis of rotation of the drive gear 42 to measure a magnetic field of a magnet member 64 and thereby confirm any rotation of the drive gear 42 for a given rotational input from the motor 39, where the rotation of drive gear 42 would result in a corresponding movement of plunger 44. The output of sensor 150 can thus be used to provide real-time feedback of medication being dispensed, for example, via a WC or Bluetooth device to a smart phone. In another exemplary implementation, the output of sensor 150 can facilitate accurate control of the dispensing operation of the IDD. According to exemplary configurations, sensor 150 can be positioned at a predetermined distance from the magnet member 64 to increase or decrease sensitivity of the magnetic field measurement. In some exemplary embodiments, the sensor 150 is attached to the pump drive mechanism 37.

[0076] Referring back to FIG. 6C, FIG. 6C also illustrates an exemplary configuration of the magnetic encoder 60 cooperating with the gear train assembly 36 and the sensor 50. The magnetic encoder 60 includes an encoder hub 62, for example, configured on or integrated with a drive gear 42, and the magnet member 64, for example, including multiple magnets 64a, 64b, 64c, 64d, 64e, 64f, 64g, 64h configured on encoder or integrated with encoder hub 62, creating a magnetic field. During operation, the magnet member 64 rotates with drive gear 42 and as a magnet passes over the Hall Effect sensor 150, an interrupt measured by sensor 150 is triggered. The interrupt aids in determining a rotational position of the drive gear 42 and the gear train assembly 36 as measured by the Hall Effect sensor 150 and facilitates monitoring of accurate operation of the drive gear 42 and the gear train assembly 36.

[0077] In some embodiments, encoder hub 62 is mechanically coupled to the drive gear 42, which rotationally advances the leadscrew 35. Accordingly, output of Hall Effect sensor 150 based on rotation of encoder hub 62 can facilitate measuring or monitoring the rotational positionof drive gear 42, whereby implementation of a magnetic encoder 60 can ensure continuity of the gear train assembly 36. For example, if the number of interrupts measured by sensor 150 do not match an expected amount, for example, with a certain time period, the magnetic encoder 60 can trigger an alarm. The alarm notifies the user that the motor 39 and the magnetic encoder 60, and therefore drive gear 42, are sufficiently decoupled, for example due to lack of continuity of gear train assembly 36. In some embodiments, such feedback of encoder 60 can be used, for example, to determine under rotation and / or over rotation of the drive gear 42, as an indication of under dosing and overdosing of medicament to the patient due to corresponding axial movement of plunger 44.

[0078] In some embodiments, magnetic material of the magnet member 64 can be changed to provide different magnetic field strengths (N52 or N42, for example). Exemplary base materials of magnets that can be used include neodymium and iron oxide, although other magnet materials are contemplated as understood by one skilled in the art. In some embodiments, the magnet member 64 includes one or more magnets 64a, 64b, 64c, 64d, 64e, 64f, 64g, 64h, etc. disposed on the encoder hub 62 which is coupled to the drive gear 42. When two or more magnets 64a, 64b, 64c, 64d, 64e, 64f, 64g, 64h, etc. are configured equidistantly from each other and at the same distance from central axis of drive gear 42, an expected number of interrupts can be observed by the Hall Effect sensor 150 over one full rotation of the drive gear 42, which in turn is based on the input rotation of the motor 39 via gear train assembly 36.

[0079] In some embodiments, the battery 38 is a non-rechargeable disposable battery. In some embodiments, the non-rechargeable disposable battery 38 is a AAAA (Quad A) battery. In some embodiments, the motor 39 and the gearbox is a brushed DC (BDC) motor with planetary gearbox. In some embodiments, the motor driver 70 is an H-bridge motor driver integrated circuit (IC) chip that acts as the interface between the BLE MCU and the motor 39 and the gearbox. In some embodiments, an IDD 10 of the present disclosure includes a Quad A battery that powers a BDC motor with a 2.6 operating voltage and a 2 mNm operating load. In some embodiments, an H-bridge motor driver is used to drive the BDC motor. In some embodiments, the motor driver 70 used in an IDD 10 of the present disclosure is part number DRV8837C 1 -A Low-voltage H-bridge driver from Texas Instruments.

[0080] There are a few methods of energizing the motor that can be employed. In some embodiments, direct application of voltage can be used to keep the output voltage constant. Insome embodiments, PWM of the voltage can be used to output a pattern of pulses of voltage from the battery-powered motor driver 70 to the motor 39 and the gearbox. In some embodiments, the basis of the motor control algorithm used by the IDD 10 uses a variable PWM ramping scheme upon start of the motor motion when dosing. At the end of the motor movement (end of incremental dose) braking is used to help dissipate the inertia built up by the mechanical system to ensure minimal excess travel. Various braking mechanisms for a DC motor can be employed depending on motor and circuit topology, including but not limited to, regenerative braking, rheostatic or dynamic braking, and plugging or reverse current braking.

[0081] The memory of the BLE MCU stores executable software instructions for the processor to execute a PWM pattern. The outputs are controlled using a PWM input interface (also called an IN1 / IN2 interface). A low-power sleep mode can also be included. Each output is controlled by a corresponding input pin. In some embodiments, the necessary driver Field-Effect Transistors (FET) and FET control circuitry is integrated into a single device. In addition, the motor driver 70 adds protection features including undervoltage lockout, overcurrent protection, short circuit protection, and thermal shutdown.

[0082] In some embodiments, a medical device may carry out a method to control power applied to a motor to supply a drug to a patient, which may be done using a ramp-up to avoid a battery life impact that could arise when other power application techniques are used. An example of such a process 700 is shown in FIG. 7. In the example of process 700, a motor control facility (or, in other embodiments, a circuit) can, in block 702, apply an initial power to the motor. For example, the initial voltage applied to the motor can be a function of at least one of the startup minimum operating voltage, internal resistance, and minimum current to overcome inherent friction / stiction of the system (for example, associated with a gear train). This initial power may, in some cases, be a minimum voltage needed for the motor to begin moving. In some such embodiments, the motor control facility may apply the initial voltage by setting an initial duty cycle of a PWM. In some embodiments, the motor control circuit, or driver circuit, is configured to increase a duty cycle of the PWM signal from an initial zero level to an initial non- zero level to initiate motion of the motor, and then ramp up to a target level during drug administration. For example, an initial duty cycle of the PWM may involve applying power to the motor for a portion of a duty cycle of the PWM such that an average voltage over the duty cycle matches the minimum movement voltage of the motor. In block 704, the motor control facility may ramp up the voltageover a number of iterations. In embodiments that use PWM, in each iteration a portion of the duty cycle may be extended, such that power is applied to the motor for longer and longer across iterations and the amount of power applied in each iteration rises. In block 708, the motor control facility may reach a target power application for the medical device, which in embodiments that use PWM may be a target duty cycle. This may, in some medical devices, be a 100% duty cycle such that continuous power is applied throughout duty cycles or there is otherwise no suspension of power application between duty cycles. In other embodiments, a different target power or target duty cycle may be used, such as a duty cycle that provides a target voltage, as embodiments are not limited in this respect.

[0083] In some embodiments, an infusion delivery device of the present disclosure comprises an embedded printed circuit board, at least one microcontroller having a processing element and storage (e.g., memory), a motor driver integrated circuit chip, a brushed DC (“BDC”) geared motor, a Quad A battery with a rating of 1 ,5V that powers the BDC geared motor with an operating voltage of 2.6V, a reservoir configured to hold up to 300 units of insulin, a drivetrain comprising a pinion gear coupled with the BDC geared motor, 2 compound gears, and a drive gear that rotates a drive nut that is rotationally coupled with a leadscrew connected with a pusher element linearly moveable within the reservoir. The drivetrain can perform a medicine dispensing operation when the amount of energy delivered to the drivetrain during the medicine dispensing operation is ramped up from an initial energy amount (with minimal energy) to a target energy amount (e.g., a PWM profile). A controller device can be configured to initiate the medicine dispensing operation by supplying a pattern of voltage pulses to the drivetrain. In some embodiments, the pattern of voltage pulses is a constant string of pulses used by the driver circuit to engage the drivetrain. In some embodiments, the pattern of pulses is stored in memory, and the processor can receive, from the memory, the pattern of pulses to apply them to drive the motor.

[0084] In some embodiments, the driver circuit is configured to ramp up the power (e.g., by ramping up voltage) in a linear fashion from initial voltage to target voltage. While an example of a linear ramp-up is described, it should be understood that any suitable ramp-up configuration can be employed. For example, the power can be ramped up in an exponential or logarithmic manner.

[0085] In some embodiments, the driver circuit can be configured to ramp the duty cycle from 20% + / - 5% to 100% + / - 5%. In some embodiments, the driver circuit can be configured toramp the duty cycle from 40% + / - 5% to 100% + / - 5%. In some embodiments, this ramping of the duty cycle can occur over a period of 10ms, 20ms, or 50ms using a frequency of 10kHz, 20kHz, or 40kHz. In some embodiments, each of the time periods can have a range of + / - 2%, 5%, or 10%, and each of the frequencies can have a range of + / - 2%, 5%, or 10%.

[0086] For example, a driver circuit is configured to ramp up and brake the BDC geared motor and is defined as: (1) when dispensing a dose increment, the memory shall linearly ramp the duty cycle from 40% + / - 5% to 100% + / - 5% over a period of 20ms + / - 5% using a frequency of 20kHz + / - 5%, and (2) when dispensing a dose, the memory shall first brake the motor when a toggle is detected from the high resolution index encoder and then disable the motor driver. In another example, a driver circuit is configured to ramp up and brake the BDC geared motor and is defined as: (1) when dispensing a dose increment, the memory shall linearly ramp the duty cycle from 40% + / - 2% to 100% + / - 2% over a period of 20ms + / - 2% using a frequency of 20kHz + / - 2%, and (2) when dispensing a dose, the memory shall first brake the motor when a toggle is detected from the high resolution index encoder and then disable the motor driver. In another example, a driver circuit is configured to ramp up and brake the BDC geared motor and is defined as: (1) when dispensing a dose increment, the memory shall linearly ramp the duty cycle from 40% + / - 1% to 100% + / - 1% over a period of 20ms + / - 1% using a frequency of 20kHz + / - 1%, and (2) when dispensing a dose, the memory shall first brake the motor when a toggle is detected from the high resolution index encoder and then disable the motor driver. Performing this specific ramp and braking implementation in the IDD allows for various features of motor control. In some embodiments, ramping of the voltage reduces the instantaneous current spike drawn by the motor upon initial application of the drive voltage. The initial current spike may arise at least in part due to the large stall current of the motor.

[0087] In some embodiments a medical device may carry out a method to control spinning of a motor at an end of a cycle of dosing of a drug, to reduce a risk of inadvertent overdosing of the patient. An example of such a process 800 is shown in FIG. 8. In process 800 of FIG. 8, a motor control facility (or, in other embodiments, a circuit) can in block 802 apply braking to a motor. In block 804, this results in the motor stopping, which can prevent an over-delivery of the drug, such as insulin, in the reservoir of the IDD. PWM and braking control can be implemented in hardware, firmware, or software. For example, PWM and braking control can be controlled via firmware using a H-Bridge Motor driver IC to drive and brake the motor, which can have softwareor firmware control.

[0088] FIG. 9 illustrates an exemplary embodiment of a circuit for controlling the motor of a medical device 900. As shown, a driver circuit 902 can be used to drive a motor 904. The driver circuit 902 can carry out operations to ramp up a voltage applied to the motor using pulse width modulation or another technique to vary power applied during a duty cycle. The driver circuit 902 can achieve this with timing circuits, voltage regulation circuits, or other circuits. In some embodiments, the driver circuit 902 can be a controller that executes instructions such as firmware or software and can receive updated instructions from outside the IDD to be stored for future execution. In some cases, the driver circuit 902 can be at least one processor. In some embodiments, one or more additional circuits (e.g., processors) can be used as a backup system for a main circuit, which may be used to provide redundancy and failure mitigation in the case of a medical device that is providing a material (e.g., insulin) that is critical or important to health. Having such a backup may reduce a risk of a component failure (e.g., of a circuit) having a negative impact on health of a patient.

[0089] A remote pump control device and / or computer that can be used with an IDD 10 of the present disclosure in one embodiment comprises at least one processor, a network adapter, and computer- readable storage media. The computing device may be, internal to the IDD 10, or external such as, for example, via a desktop or laptop personal computer, a personal digital assistant (PDA), a smart mobile phone, a wireless controller, a server, a wireless access point or other networking element, or any other suitable computing device.

[0090] In some embodiments, the computing device may comprise a remote consumer electronic device or WC comprising applications and cloud service. The term “cloud service” refers to a service that is provided over a network connection, via a non-local computer. The WC can be a mobile phone, such as a smartphone, via, for example, Bluetooth®, Bluetooth® low energy, mobile, Wi-Fi or other communications protocols and modalities. Alternate types of WCs could be used in place of a phone, including, for example, an electronic tablet or a laptop or desktop computer. In some embodiments, the IDD 10 is paired with the WC as an initial step in the user experience. The IDD 10 includes a power button 30 which can be depressed by the user and will blink the power button indicia 302, noting that it is ready to pair with the WC. The application running on the WC will ask the user to pair the IDD 10 with the controller and the step is initiated. The WC will notify the user when the IDD 10 has successfully been paired with it. The IDD 10 isnow ready for the next step.

[0091] The WC is a device that controls and monitors the IDD’s 10 operations, such as of the pump, alarms, etc., using wireless technology and recognizes user inputs via a power button 30 and graphical user interface (GUI). The WC includes a mobile application that a user can launch. The mobile application can be provided, for example, by a vendor of the IDD 10 that is being operated. The application can provide the necessary drivers and communication protocols to support fulfilment of system functions. In some embodiments, a WC is a device that has its own processor, memory, etc. that is useable for a variety of functions, such as, for example, phone calls, emails, and accessing the internet, beyond simply being a remote-control device for a medical device. In some embodiments of each of the systems and methods described throughout this disclosure, however, a WC used with the present disclosure can be a dedicated remote-control device.

[0092] A WC of the present disclosure is configured to communicate insulin delivery instructions to the IDD 10 which is configured to receive the insulin delivery instructions and includes a user-interactive touchscreen display and at least one processor. The WC presents audible, visual, and haptic feedback to a user. The WC can include a Wi-Fi radio and a baseband processor for sending and receiving data to a cloud services interface. The baseband processor processes data associated with bolus dose calculator entered inputs, tracking of basal and bolus dosing in progress and tracking confirmations and alarms. The WC can store data associated with paring information, settings, basal and bolus dose pre-set programs, entered dose calculator settings, entered blood glucose reading, comment, carbs, entered dose calculator inputs, delivered basal and bolus doses, and all messages received from the IDD 10 via the Bluetooth link. The WC also manages faults for certain conditions, including but not limited to, memory corruption, lower power, and synchronization.

[0093] In some embodiments, a motor subsystem is disclosed and includes a motor configured to control dosing of a drug to a patient and a driver circuit configured to control a power supply to the motor during administration of the drug to the patient. The driver circuit is configured to, at a start of an administration of the drug to the patient, apply an initial power supply to the motor and increase the power supply to the motor over time from the initial power supply to a target power supply. The initial power supply supplies a voltage to begin rotation of the motor for administration of the drug. In some embodiments, the motor is a brushed DC motor that is poweredby a Quad A batery.

[0094] In some embodiments, the driver circuit is configured to apply braking to the motor at an end of the administration of the drug. In some embodiments, the driver circuit is configured to apply braking at least in part by applying a logic low at both terminals of the motor. In some embodiments, the driver circuit is configured to ramp up and brake the brushed DC motor and is defined as: (1) when dispensing a dose increment, a memory shall linearly ramp the duty cycle from 40% to 100% + / - 5% over a period of 20ms + / - 5% using a frequency of 20kHz + / - 5%, and (2) when dispensing a dose, the memory shall first brake the motor when a toggle is detected from the high resolution index encoder and then disable the motor driver.

[0095] In some embodiments, the driver circuit is configured to execute instructions to cause the increase in the power supply from the initial power supply to the target power supply. In some embodiments, the driver circuit is a processor. In some embodiments, the driver circuit employs firmware.

[0096] In some embodiments, the driver circuit is configured to increase the power supply linearly over time from the initial power supply to the target power supply. In some embodiments, the driver circuit is configured to increase the power supply over time by controlling the power supply to the motor across a sequence of iterations, wherein the driver circuit increases the power supply by a set amount in each iteration of the sequence of iterations.

[0097] In some embodiments, the motor is configured to communicate with a drive mechanism, the drive mechanism being configured to dispense the drug from a reservoir within an infusion device. In some embodiments, the drive mechanism is configured to interact with a floating plunger in the reservoir to dispense the drug from the reservoir. In some embodiments, the drug is insulin.

[0098] In some embodiments, the driver circuit is configured to supply power to the motor using pulse width modulation (PWM). In some embodiments, the driver circuit is configured to increase the power supply over time at the start of the administration of the drug by increasing over time a width of a PWM signal supplied to the motor.

[0099] In some embodiments, a method of controlling a motor is disclosed and includes applying, using a driver circuit, an initial power supply to a motor during administration of a drug to a patient, the motor controlling a drive mechanism for dispensing the drug to the patient, and increasing, using the driver circuit, the power supply to the motor over time from the initial power 1supply to a target power supply. The initial power supply supplies a voltage to begin rotation of the motor for administration of the drug.

[0100] In some embodiments, a disposable insulin infusion pump is disclosed and includes a housing comprising a top enclosure, a bottom enclosure, and an insertion mechanism. The bottom enclosure supports the insertion mechanism, a brushed DC (“BDC”) geared motor, a Quad A battery with a rating of 1 ,5V that powers the BDC geared motor with an operating voltage of 2.6V, an embedded printed circuit board, at least one microcontroller having a processing element and storage (e.g., memory), a driver circuit, a reservoir configured to hold up to 300 units of insulin, a drivetrain comprising a pinion gear coupled with the BDC geared motor, 2 compound gears, and a drive gear that rotates a drive nut that is rotationally coupled with a leadscrew connected with a pusher element linearly moveable within the reservoir. The drivetrain can perform a medicine dispensing operation when the amount of energy delivered to the drivetrain during the medicine dispensing operation is ramped up from an initial energy amount to a target energy amount (e.g., a PWM profile). The driver circuit is configured to, at a start of an administration of insulin to the patient, apply an initial power supply to the motor and increase the power supply to the motor over time from the initial power supply to a target power supply and to apply braking to the motor at an end of the administration of insulin. In some embodiments, the driver circuit is configured to ramp up and brake the brushed DC motor and is defined as: (1) when dispensing a dose increment, a memory shall linearly ramp the duty cycle from 40% to 100% + / - 5% over a period of 20ms + / - 5% using a frequency of 20kHz + / - 5%, and (2) when dispensing a dose, the memory shall first brake the motor when a toggle is detected from the high resolution index encoder and then disable the motor driver..

[0101] Techniques operating according to the principles described herein may be implemented in any suitable manner. Included in the discussion above are a series of flow charts showing the steps and acts of various processes that control application of a power to a motor of a medical device. The processing and decision blocks of the flow charts above represent steps and acts that may be included in algorithms that carry out these various processes. Algorithms derived from these processes may be implemented as software integrated with and directing the operation of one or more single or multi-purpose processors, may be implemented as functionally equivalent circuits such as a Digital Signal Processing (DSP) circuit or an Application-Specific Integrated Circuit (ASIC), or may be implemented in any other suitable manner. It should be appreciated thatthe flow charts included herein do not depict the syntax or operation of any particular circuit or of any particular programming language or type of programming language. Rather, the flow charts illustrate the functional information one skilled in the art may use to fabricate circuits or to implement computer software algorithms to perform the processing of a particular apparatus carrying out the types of techniques described herein. It should also be appreciated that, unless otherwise indicated herein, the particular sequence of steps and / or acts described in each flow chart is merely illustrative of the algorithms that may be implemented and can be varied in implementations and embodiments of the principles described herein.

[0102] Accordingly, in some embodiments, the techniques described herein may be embodied in computer-executable instructions implemented as software, including as application software, system software, firmware, middleware, embedded code, or any other suitable type of computer code. Such computer-executable instructions may be written using any of a number of suitable programming languages and / or programming or scripting tools, and also may be compiled as executable machine language code or intermediate code that is executed on a framework or virtual machine.

[0103] When techniques described herein are embodied as computer-executable instructions, these computer-executable instructions may be implemented in any suitable manner, including as a number of functional facilities, each providing one or more operations to complete execution of algorithms operating according to these techniques. A “functional facility,” however instantiated, is a structural component of a computer system that, when integrated with and executed by one or more computers, causes the one or more computers to perform a specific operational role. A functional facility may be a portion of or an entire software element. For example, a functional facility may be implemented as a function of a process, or as a discrete process, or as any other suitable unit of processing. If techniques described herein are implemented as multiple functional facilities, each functional facility may be implemented in its own way; all need not be implemented the same way. Additionally, these functional facilities may be executed in parallel and / or serially, as appropriate, and may pass information between one another using a shared memory on the computer(s) on which they are executing, using a message passing protocol, or in any other suitable way.

[0104] Generally, functional facilities include routines, programs, objects, components, data structures, etc. that perform particular tasks or implement particular abstract data types.Typically, the functionality of the functional facilities may be combined or distributed as desired in the systems in which they operate. In some implementations, one or more functional facilities carrying out techniques herein may together form a complete software package. These functional facilities may, in alternative embodiments, be adapted to interact with other, unrelated functional facilities and / or processes, to implement a software program application.

[0105] Some exemplary functional facilities have been described herein for carrying out one or more tasks. It should be appreciated, though, that the functional facilities and division of tasks described is merely illustrative of the type of functional facilities that may implement the exemplary techniques described herein, and that embodiments are not limited to being implemented in any specific number, division, or type of functional facilities. In some implementations, all functionality may be implemented in a single functional facility. It should also be appreciated that, in some implementations, some of the functional facilities described herein may be implemented together with or separately from others (i.e., as a single unit or separate units), or some of these functional facilities may not be implemented.

[0106] Computer-executable instructions implementing the techniques described herein (when implemented as one or more functional facilities or in any other manner) may, in some embodiments, be encoded on one or more computer-readable media to provide functionality to the media. Computer-readable media include magnetic media such as a hard disk drive, optical media such as a Compact Disk (CD) or a Digital Versatile Disk (DVD), a persistent or non-persistent solid-state memory (e.g., Flash memory, Magnetic RAM, etc.), or any other suitable storage media. Such a computer-readable medium may be implemented in any suitable manner, including as computer- readable storage media 406 of FIG. 10 described below (i.e., as a portion of a computing device 400) or as a stand-alone, separate storage medium. As used herein, “computer-readable media” (also called “computer-readable storage media”) refers to tangible storage media. Tangible storage media are non-transitory and have at least one physical, structural component. In a “computer-readable medium,” as used herein, at least one physical, structural component has at least one physical property that may be altered in some way during a process of creating the medium with embedded information, a process of recording information thereon, or any other process of encoding the medium with information. For example, a magnetization state of a portion of a physical structure of a computer-readable medium may be altered during a recording process.

[0107] In some, but not all, implementations in which the techniques may be embodied ascomputer-executable instructions, these instructions may be executed on one or more suitable computing device(s) operating in any suitable computer system, or one or more computing devices (or one or more processors of one or more computing devices) may be programmed to execute the computer-executable instructions. A computing device or processor may be programmed to execute instructions when the instructions are stored in a manner accessible to the computing device or processor, such as in a data store (e.g., an on-chip cache or instruction register, a computer-readable storage medium accessible via a bus, a computer-readable storage medium accessible via one or more networks and accessible by the device / processor, etc.). Functional facilities comprising these computer-executable instructions may be integrated with and direct the operation of a single multi-purpose programmable digital computing device, a coordinated system of two or more multi-purpose computing device sharing processing power and jointly carrying out the techniques described herein, a single computing device or coordinated system of computing devices (co-located or geographically distributed) dedicated to executing the techniques described herein, one or more Field-Programmable Gate Arrays (FPGAs) for carrying out the techniques described herein, or any other suitable system.

[0108] FIG. 10 illustrates one exemplary implementation of a computing device in the form of a computing device 400 that may be used in a system implementing techniques described herein, although others are possible. It should be appreciated that FIG. 10 is intended neither to be a depiction of necessary components for a computing device to operate in accordance with the principles described herein, nor a comprehensive depiction.

[0109] Computing device 400 may comprise at least one processor 402, a network adapter 404, and computer-readable storage media 406. Computing device 400 may be, for example, a medical device. As another example, computing device 400 may be a desktop or laptop personal computer, a personal digital assistant (PDA), a smart mobile phone, or any other suitable computing device. Network adapter 404 may be any suitable hardware and / or software to enable the computing device 400 to communicate wired and / or wirelessly with any other suitable computing device over any suitable computing network. The computing network may include wireless access points, switches, routers, gateways, and / or other networking equipment as well as any suitable wired and / or wireless communication medium or media for exchanging data between two or more computers, including the Internet. Computer-readable storage media 406 may be adapted to store data to be processed and / or instructions to be executed by processor 402. Processor402 enables processing of data and execution of instructions. The data and instructions may be stored on the computer-readable storage media 406.

[0110] The data and instructions stored on computer-readable storage media 406 may comprise computer-executable instructions implementing techniques which operate according to the principles described herein. In the example of FIG. 10, computer-readable storage media 406 stores computer-executable instructions implementing various facilities and storing various information as described above. Computer-readable storage media 406 may store a motor control facility 408 that may perform motor control techniques as described above.

[0111] While not illustrated in FIG. 10, a computing device 400 may additionally have one or more components and peripherals, including input and output devices. These devices can be used, among other things, to present a user interface. Examples of output devices that can be used to provide a user interface include printers or display screens for visual presentation of output and speakers or other sound generating devices for audible presentation of output. Examples of input devices that can be used for a user interface include keyboards, and pointing devices, such as mice, touch pads, and digitizing tablets. As another example, a computing device may receive input information through speech recognition or in other audible format.

[0112] Embodiments have been described where the techniques are implemented in circuitry and / or computer-executable instructions. It should be appreciated that some embodiments may be in the form of a method, of which at least one example has been provided. The acts performed as part of the method may be ordered in any suitable way. Accordingly, embodiments may be constructed in which acts are performed in an order different than illustrated, which may include performing some acts simultaneously, even though shown as sequential acts in illustrative embodiments.

[0113] This disclosure provides exemplary embodiments only, and is not intended to limit the scope, applicability, or configuration of the disclosure. Rather, this description of the exemplary embodiments will provide those skilled in the art with an enabling description for implementing one or more exemplary embodiments. It will be understood that various changes may be made in the function and arrangement of elements without departing from the spirit and scope of the presently disclosed embodiments. Embodiment examples are described with reference to the figures. Identical, similar, or identically acting elements in the various figures are identified with identical reference numbers and a repeated description of these elements is omitted in part toavoid redundancies.

[0114] Although various persons, including, but not limited to, a patient or a healthcare professional, can operate or use illustrative embodiments of the present disclosure, for brevity an operator or user is referred to as a “user” herein.

[0115] Although various fluids can be employed in illustrative embodiments of the present disclosure, for brevity the liquid in an injection device is referred to as “fluid” herein.

[0116] It will be understood by one skilled in the art that this disclosure is not limited in its application to the details of construction and the arrangement of components set forth in the above description or illustrated in the drawings. The embodiments herein are capable of other embodiments, and capable of being practiced or carried out in various ways. Also, it will be understood that the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting. The use of “including,” “comprising,” or “having” and variations thereof herein is meant to encompass the items listed thereafter and equivalents thereof as well as additional items. Unless limited otherwise, the terms “connected,” “coupled,” and “mounted,” and variations thereof herein are used broadly and encompass direct and indirect connections, couplings, and mountings. In addition, the terms “connected” and “coupled” and variations thereof are not restricted to physical or mechanical connections or couplings. Further, terms such as up, down, bottom, and top are relative, and are employed to aid illustration, but are not limiting.

[0117] All patents and publications mentioned in this specification are herein incorporated by reference to the same extent as if each independent patent and publication was specifically and individually indicated to be incorporated by reference.

Claims

CLAIMSWhat is claimed is:

1. A drug delivery motor subsystem, comprising: a microcontroller configured to send digital control signals to a driver circuit; and a motor configured to initiate drug dosing upon receiving a Pulse Width Modulation (PWM) signal from the driver circuit, wherein the driver circuit is configured to increase a duty cycle of the PWM signal from an initial level above zero to a target level during drug administration, and wherein the driver circuit is configured to initiate braking of the motor post-administration of the drug.

2. The drug delivery motor subsystem of claim 1, wherein, upon receiving a PWM signal from the driver circuit, the motor moves from a stationary state, in which the motor is not moving, to the initial level.

3. A drug delivery motor subsystem, comprising: a microcontroller configured to send digital control signals to a driver circuit; and a motor configured to initiate drug dosing upon receiving a Pulse Width Modulation (PWM) signal from the driver circuit, wherein the driver circuit is configured to increase a duty cycle of the PWM signal from an initial zero level to an initial non-zero level to initiate motion of the motor to a target level during drug administration, and wherein the driver circuit is configured to initiate braking of the motor post-administration of the drug.

4. The drug delivery motor subsystem of any one of claims 1-3, wherein the motor is a brushed DC motor that is powered by a Quad A battery.

5. The drug delivery motor subsystem of any one of claims 1-3, wherein the driver circuit is configured to linearly ramp the duty cycle from an initial level of 40% + / - 5% to a target level of 100% + / - 5% over a period of 20ms + / - 5% using a frequency of 20kHz + / - 5%.

6. The drug delivery motor subsystem of any one of claims 1-3, wherein the driver circuit is an H-bridge driver circuit.

7. The drug delivery motor subsystem of any one of claims 1-3, wherein the PWM signal iscontrolled by firmware.

8. The drug delivery motor subsystem of any one of claims 1-3, wherein the driver circuit is configured to increase the duty cycle of the PWM signal linearly over time from the initial level to the target level.

9. The drug delivery motor subsystem of any one of claims 1-3, wherein the driver circuit is configured to increase the duty cycle of the PWM signal over time by controlling power supply to the motor across a sequence of iterations, wherein the driver circuit increases the power supply by a set amount in each iteration of the sequence of iterations.

10. The drug delivery motor subsystem of any one of claims 1-3, wherein the motor is configured to communicate with a drive mechanism, the drive mechanism being configured to dispense the drug from a reservoir within a drug delivery device.

11. A disposable infusion pump, comprising: a microcontroller; a driver circuit configured to receive digital control signals from the microcontroller; a motor configured to initiate drug dosing upon receiving a Pulse Width Modulation (PWM) signal from the driver circuit; a battery configured to power the motor; a reservoir configured to hold a drug; a plunger moveably disposed in the reservoir; and a leadscrew coupled to the motor, and configured to be actuated by the motor to move the plunger linearly along the reservoir to enable administration of the drug from the reservoir to a patient, wherein the driver circuit is electrically connected to the battery and is configured to increase a duty cycle of a Pulse Width Modulation (PWM) signal from an initial level above zero to a target level during drug administration; and wherein the driver circuit is configured to initiate braking of the motor post-administration of the drug.

12. The disposable infusion pump of claim 11, wherein the motor is a brushed DC motor that is powered by a Quad A battery.

13. The disposable infusion pump of claim 11, the driver circuit is configured to linearly ramp a duty cycle from an initial level of 40% + / - 5% to a target level of 100% + / - 5% over a period of 20ms + / - 5% using a frequency of 20kHz + / - 5%.

14. The disposable infusion pump of claim 11 , wherein the driver circuit is an H-bridge driver circuit.

15. The disposable infusion pump of claim 11, wherein the PWM signal is controlled by firmware.

16. The disposable infusion pump of claim 11, wherein the driver circuit is configured to - increase the duty cycle of the PWM signal linearly over time from the initial level to the target level.

17. The disposable infusion pump of claim 11, wherein the driver circuit is configured to increase the duty cycle of the PWM signal over time by controlling power supply to the motor across a sequence of iterations, wherein the driver circuit increases the power supply by a set amount in each iteration of the sequence of iterations.

18. A method of controlling a motor, comprising: applying, using a driver circuit, a Pulse Width Modulation (PWM) signal to a motor during administration of a drug to a patient, the motor controlling a drive mechanism for dispensing the drug to the patient; increasing, using the driver circuit, a duty cycle of the PWM signal from an initial level above zero to a target level during drug administration; and initiating, using the driver circuit, braking of the motor post-administration of the drug, wherein the initial level of the duty cycle of the PWM signal begins rotation of the motor for administration of the drug.

19. The method of claim 18, wherein the driver circuit linearly ramps a duty cycle from an initial level of 40% + / - 5% to a target level of 100% + / - 5% over a period of 20ms + / - 5% using a frequency of 20kHz + / - 5%.

20. The method of claim 18, wherein applying braking comprising at least one of regenerative braking, rheostatic or dynamic braking, and plugging or reverse current braking.

21. The method of claim 18, wherein the driver circuit increases the duty cycle of the PWM signal linearly over time from the initial level to the target level.

22. The method of claim 18, wherein the driver circuit increases the duty cycle of the PWM signal over time by controlling power supply to the motor across a sequence of iterations, wherein the driver circuit increases the power supply by a set amount in each iteration of the sequence of iterations.

23. The method of claim 18, wherein the motor is a brushed DC motor that is powered by a Quad A battery.

24. The method of claim 18, wherein the driver circuit is an H-bridge driver circuit.

25. The method of claim 18, wherein the PWM signal is controlled by firmware.

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