Clutch device for compact positive displacement pumps in wearable drug delivery devices

Abstract

The disclosed embodiments relate to techniques, processes, devices, or systems for pump devices. In one approach, a wearable drug delivery device includes a reservoir configured to contain a fluid, the reservoir including a housing, the housing including an outer wall defining an interior chamber, and a drive mechanism for expelling the fluid from the reservoir. The drive mechanism includes a plunger received within the interior chamber of the reservoir, a lead screw extending from the plunger, and a clutch mechanism in threaded engagement with the lead screw. The clutch mechanism is configured to allow the lead screw to pass through the clutch mechanism when disengaged, and configured to grip the lead screw and rotate the clutch mechanism to advance the lead screw and the plunger into the reservoir when engaged.

Description

Technical Field

[0001] (Cross - Reference to Related Applications) This application claims the benefit of U.S. Provisional Patent Application No. 63 / 241,633, filed on September 8, 2021. The entire content of the application is incorporated herein by reference.

[0002] The embodiments disclosed herein generally relate to drug delivery. More particularly, the disclosed embodiments relate to techniques, processes, systems, and dispensing devices for delivering fluidic drugs in a space - saving manner.

Background Art

[0003] Fluid delivery devices have many applications, such as subcutaneous delivery of fluidic drugs to patients. For example, in diabetic patients, portable infusion pumps are used to deliver insulin to the patient. These infusion pumps have the ability to provide sophisticated fluid delivery profiles that include variable basal rates and bolus requirements. The ability to carefully control drug delivery can enhance the effectiveness of the drug and treatment and reduce toxicity to the patient.

[0004] Some existing infusion pumps include a reservoir for containing the fluidic drug and use electromechanical pumping or metering techniques to deliver the fluidic drug through a tube to a needle and / or a soft cannula inserted subcutaneously into the patient. Some infusion pumps are designed to be relatively small, low - cost, lightweight, and easy to use. These pumps include an insertion mechanism for delivering the needle and / or the soft cannula to the patient. However, the design of the insertion mechanism can be improved to reduce the size of the pump, improve user comfort, and / or reduce the number of pump components.

[0005] Therefore, there is a need for a more simplified system that accurately discharges the fluidic drug from the reservoir and also reduces the overall size of the drug delivery device. [Overview of the Initiative]

[0006] This summary is provided to introduce some of the concepts described in more detail below in a simplified form. This summary is not intended to identify the main or essential features of the claimed subject matter, nor is it intended to assist in determining the scope of the claimed subject matter.

[0007] In some approaches, a wearable drug delivery device may comprise a reservoir configured to contain a fluid, the reservoir comprising a housing having an outer wall defining an internal chamber, and a drive mechanism for discharging the fluid from the reservoir. The drive mechanism may comprise a plunger received within the internal chamber of the reservoir, a lead screw extending from the plunger, and a clutch mechanism screwed to the lead screw, wherein the clutch mechanism is configured to allow the lead screw to pass through the clutch mechanism when disengaged, and to grip the lead screw so that the clutch mechanism rotates to advance the lead screw and plunger within the reservoir when engaged.

[0008] In some approaches, a wearable drug delivery device may comprise a reservoir configured to contain a liquid drug, the reservoir comprising a housing, the housing comprising an outer wall defining an internal chamber, and a drive mechanism for discharging the liquid drug from the reservoir. The drive mechanism may comprise a plunger received within the internal chamber of the reservoir, a lead screw extending from the plunger, and a drive wheel operable with a clutch mechanism to rotate a clutch spring to advance the lead screw, wherein the clutch mechanism is configured such that, when in the disengaged position, the lead screw passes over the clutch spring, and when in the engaged position, the drive wheel grips the lead screw so as to rotate the clutch spring to advance the lead screw and the plunger into the reservoir.

[0009] In some approaches, the method may include providing a reservoir configured to contain a liquid agent, the reservoir comprising a housing, the housing comprising an outer wall defining an internal chamber, and providing a drive mechanism for discharging the liquid agent from the reservoir. The drive mechanism may comprise a plunger received within the internal chamber of the reservoir, a lead screw extending from the plunger, a clutch mechanism, and an operable drive wheel. The method may further include rotating a clutch spring of the clutch mechanism to advance the lead screw, wherein the clutch mechanism is configured to allow the lead screw to pass through the clutch spring when in the disengaged position, and to grip the lead screw when in the engaged position.

[0010] In the drawings, similar reference numerals generally refer to equivalent parts across different drawings. Various embodiments of the present disclosure are described below with reference to the following drawings. [Brief explanation of the drawing]

[0011] [Figure 1] Figure 1 shows a schematic diagram of a drug delivery system according to an embodiment of the present disclosure.

[0012] [Figure 2] Figure 2 shows a perspective view of the drive mechanism of a delivery pump device according to an embodiment of the present disclosure.

[0013] [Figure 3A] Figure 3A shows a perspective view of a portion of the drive mechanism shown in Figure 2, according to an embodiment of the present disclosure.

[0014] [Figure 3B] Figure 3B is a side cross-sectional view showing a portion of the drive mechanism according to an embodiment of the present disclosure.

[0015] [Figure 4A] Figure 4A shows a perspective view of the lead screw and clutch spring of the drive mechanism according to an embodiment of the present disclosure. [Figure 4B] Figure 4B shows a perspective view of the lead screw and clutch spring of the drive mechanism according to an embodiment of the present disclosure.

[0016] [Figure 5A] Figure 5A is a perspective view showing a clutch spring according to an embodiment of the present disclosure. [Figure 5B] Figure 5B is a perspective view showing a clutch spring according to an embodiment of the present disclosure. [Figure 5C] Figure 5C is a perspective view showing a clutch spring according to an embodiment of the present disclosure.

[0017] [Figure 6] Figure 6 shows the process flow of the method according to an embodiment of the present disclosure.

[0018] The drawings are not necessarily to scale. The drawings are merely representations and are not intended to depict specific parameters of the present disclosure. The drawings are intended to depict exemplary embodiments of the present disclosure and should not be considered to limit the scope. Further, in some of the drawings, for clarity, certain elements may be omitted or not drawn to scale. Additionally, for clarity, some reference numerals may be omitted in certain drawings.

Best Mode for Carrying Out the Invention

[0019] The systems, devices, and methods according to the present disclosure are described more fully hereinafter with reference to the accompanying drawings, in which one or more embodiments are shown. The systems, devices, and methods can be embodied in many different forms and should not be construed as limited to the embodiments set forth herein. Instead, these embodiments are provided so that this disclosure will be thorough and complete and will fully convey the scope of the methods and devices to those skilled in the art. Each of the systems, devices, and methods disclosed herein provides one or more advantages over conventional systems, components, and methods.

[0020] One approach for operating a fluid pump is to use linear motion generated by a feed screw and a spring / clutch mechanism. This mechanism converts the rotational motion of an actuator, which can be an SMA wire, solenoid, motor, etc., into accurate linear motion. As an example, in a positive displacement fluid pump, the linear motion generated by the feed screw is transmitted to a plunger within a reservoir, resulting in accurate and controlled fluid discharge from the reservoir. During the filling process, the plunger remains disengaged from the feed screw and spring / clutch mechanism, and the fluid can freely move the plunger to any position based on the fill volume. When the user has finished filling, the spring / clutch mechanism connects to the feed screw and plunger, enabling the device to discharge fluid out of the reservoir.

[0021] In some embodiments, the spring is initially in a loaded configuration where the inner diameter (ID) is larger than the outer diameter (OD) of the feed screw, thereby allowing the spring and the feed screw to move freely relative to each other when the user fills the pod. If desired, the clutch mechanism can release the spring, thereby causing a reduction in the ID of the coil and a direct engagement of the spring and the feed screw. In some embodiments, the spring engages a threading along an outer portion of the feed screw. Thus, rotation of the feed screw results in linear movement of the spring and the plunger, thereby allowing the pod to accurately eject fluid.

[0022] In various embodiments, the wearable drug delivery device described herein can include an analyte sensor, such as a blood glucose sensor, and the cannula or microneedle array can be operable such that the device can measure the analyte level of the user of the device.

[0023] Figure 1 shows a simplified block diagram of an exemplary system (hereinafter, "System") 100. System 100 may be a wearable or on-body drug delivery device and / or an analyte sensor attached to the skin of a patient 103. System 100 may comprise a controller 102, a pump mechanism 104 (hereinafter, "Pump 104"), and a sensor 108 in one or more housings. The sensor 108 may be a glucose or other analyte monitor, such as a sustained glucose monitor, and may be integrated into a wearable device. For example, the sensor 108 may be operable to measure the user's blood glucose (BG) level and generate a measured BG level signal 112. The controller 102, pump 104, and sensor 108 may be coupled to communicate with each other via a wired or wireless communication path. For example, each of the controller 102, pump 104, and sensor 108 may include a wireless high-frequency transceiver operable to communicate via one or more communication protocols such as Bluetooth®. The system 100 may also include a delivery pump device (hereinafter, "device") 105, which includes a drive mechanism 106 coupled to the reservoir 126 for discharging the liquid agent 125 from the reservoir 126. As described in further detail herein, the drive mechanism 106 may include a piston head or plunger 134 located in an internal chamber of the housing 139 of the reservoir 126, and a lead screw 135 that can be coupled to a clutch spring 136. The system 100 may include additional components not shown or described for brevity.

[0024] Controller 102 can receive a desired BG level signal, which may be a first signal indicating a desired BG level or width for patient 103. This desired BG level signal is stored in the memory of controller 109 on device 105, received from the user interface and forwarded to controller 102 or another device, or received by an algorithm within controller 109 (or controller 102) that automatically determines an appropriate BG level or target value for patient 103. Sensor 108 may be coupled to patient 103 and may be operable to measure an approximate value of the user's BG level. Depending on the measured BG level or value, sensor 108 may generate a signal indicating the BG measurement. As illustrated, controller 102 may also receive a measured BG level signal 112 from sensor 108 via a communication path. This measured BG level signal 112 may be a second signal.

[0025] Based on the desired BG level signal and the measured BG level signal 112, controller 102 or controller 109 may generate one or more control signals to instruct the operation of pump 104. For example, one control signal 119 from controller 102 or controller 109 can turn on pump 104 or activate one or more power elements 123 operably connected to the device 105. A specified amount of liquid medication 125 may be determined as an appropriate amount of insulin to bring the user's measured BG level to the desired BG level. Based on the operation of pump 104 determined by the control signal 119, patient 103 may receive liquid medication from reservoir 126. System 100 may operate as a closed-loop system, an open-loop system, or a hybrid system. In an exemplary closed-loop system, controller 109 can instruct the operation of device 105 without input from controller 102 and can receive the BG level signal 112 from sensor 108. The sensor 108 may be housed within the device 105, or it may be housed in a separate device and communicate directly with the device 105 via wireless communication.

[0026] As further shown, system 100 may include a needle deployment element 128 communicating with controller 102 or controller 109. The needle deployment element 128 may include a needle / cannula 129 that can be deployed into the body of patient 103 and may include one or more holes at its distal end. The needle deployment element 128 may be housed within the device 105 or may be a separate component that can be connected to the device 105. The device 105 may be connected to the needle / cannula 129 by a fluid pathway element 130. The fluid pathway element 130 may be of any size or shape and may be made from any material. The fluid pathway element 130 allows a fluid, such as a liquid drug 125 in a reservoir 126, to be transferred to the needle / cannula 129.

[0027] The controller 102 / 109 may be implemented in hardware, software, or any combination thereof. The controller 102 / 109 may be, for example, a microcontroller coupled to a processor, logic circuit, or memory. The controller 102 / 109 may hold the date and time, as well as other functions (such as calculations) performed by the processor. The controller 102 / 109 may be operable to execute an artificial pancreas (AP) algorithm (not shown) stored in memory, enabling the controller 102 / 109 to direct the operation of the pump 104. For example, the controller 102 / 109 may be operable to receive input from sensor 108, which indicates the application setting for automated insulin delivery (AID). Based on the AID application setting, the controller 102 / 109 can modify the behavior of the pump 104 and, as a result, the amount of liquid medication 125 delivered to the patient 103 via the device 105.

[0028] In some embodiments, the sensor 108 may be, for example, a continuous glucose monitor (CGM). The sensor 108 may be physically separate from the pump 104, or it may be an integrated component within the same housing, or it may be physically integrated in other ways. The sensor 108 may provide the controller 102 with data indicating the user's measured or detected blood glucose level.

[0029] The power element 123 may be a battery, piezoelectric element, or the like, for supplying power to the device 105. In other embodiments, the power element 123 or an additional power source (not shown) may also supply power to other components of the pump 104, such as the controller 102, memory, sensor 108, and / or needle deployment element 128.

[0030] In one example, the sensor 108 may be a device communicatively coupled to the controller 102 and capable of operating to measure blood glucose levels at predetermined time intervals, such as every 5 minutes or every 10 minutes. The sensor 108 can provide a large number of blood glucose measurements for an AP application.

[0031] In some embodiments, when operating in normal operating mode, the pump 104 delivers insulin stored in the reservoir 126 to the patient 103 based on information provided by the sensor 108 or other functional elements of the pump 104 (e.g., blood glucose readings, target blood glucose levels, onboard insulin, previous insulin delivery, time, day of the week, input from an inertial measurement unit, GPS system-enabled device, Wi-Fi-enabled device, or similar). For example, the pump 104 may include analog and / or digital circuitry that can be implemented as a controller 102 / 109 for controlling the delivery of a drug or therapeutic agent. The circuitry used to implement the controller 102 / 109 may include dedicated discrete logic and / or discrete components, application-specific integrated circuits, microcontrollers or processors that perform the following: i.e., microcontrollers or processors that execute software instructions, firmware, programming instructions, or programming code that enables AP applications stored in memory, for example, or any combination thereof. For example, the controller 102 / 109 may execute control algorithms and other programming code. Herein, the control algorithm and other programming code can enable the controller 102 / 109 to operate in such a way as to deliver a dose of drug or therapeutic agent to the user via the pump at predetermined intervals or as needed in order to bring the blood glucose measurement to a target blood glucose level. The size and / or timing of the dose can be pre-programmed, for example, in the AP application by the patient 103 or a third party (e.g., a healthcare provider, parent or guardian, manufacturer of a wearable drug delivery device, or similar) using a wired or wireless link.

[0032] Although not shown in the figures, in some embodiments, the sensor 108 may include a processor, memory, sensing or measuring device, and communication device. The memory may be able to store instances of the AP application, as well as other programming code, and may be operable to store data related to the AP application.

[0033] In various embodiments, the sensing / measuring device of sensor 108 may include one or more sensing elements, such as a blood glucose measuring element, a blood pressure monitor, a heart rate monitor, or a blood oxygen sensor element. The sensor processor may include dedicated discrete logic and / or discrete components, application-specific integrated circuits, a microcontroller or processor that performs the following, namely, a microcontroller or processor that executes software instructions, firmware, or programming instructions stored in memory, or a combination thereof.

[0034] Moving to Figure 2, the drive mechanism 106 according to an embodiment of the present disclosure is shown in more detail. As shown, the drive mechanism 106 may be located within the internal chamber 150 of the housing 139 of the reservoir 126. The housing 139 may have an outer wall defining the internal chamber 150, the outer wall including an outer surface opposite to the inner surface. The housing 139 may be a circular or elliptical cylinder having a first end 157 opposite to a second end 158.

[0035] As further illustrated, the drive mechanism 106 may include a plunger 134 located within an internal chamber 150 of the housing 139. In some embodiments, the plunger 134 may include a seal ring 162 (e.g., an O-ring) extending circumferentially from the outer surface 163 of the plunger 134. The seal ring 162 can contact the inner surface of the outer wall of the housing 139 to form a liquid-tight seal between them. The lead screw 135 may be coupled to the plunger 134 or may be an inseparable, insert-molded assembly.

[0036] Some embodiments of the drive mechanism 106 may include a clutch mechanism 170 that facilitates the filling and discharging of fluid in the reservoir 126, and engagement with the drive mechanism 106 for releasing fluid from the reservoir 126. A clutch spring 136 can engage with a lead screw 135 and can be driven by a drive wheel 156 via the clutch mechanism 170.

[0037] As shown in Figure 2, when the reservoir 126 is empty or pre-filled, the plunger 134 is positioned at the second end 158 of the reservoir 126 such that the plunger 134 is extended and the clutch mechanism 170 is disengaged. In one embodiment, the reservoir 126 can then be filled with a fluid drug such as insulin, which can be done by opening the inlet port to the reservoir 126 and pumping insulin under sufficient hydraulic pressure to retract the plunger 134 towards the first end 157 within the reservoir 126. The inlet port can then be closed. When the reservoir 126 is filled and the plunger 134 is moving toward or towards the first end 157 of the reservoir 126, the clutch mechanism 170 remains disengaged, thereby allowing the lead screw 135 to pass through the clutch spring and enter (along the drive shaft) into the elongated cylindrical bore of the hub of the drive wheel 156. Subsequently, the clutch mechanism 170 may be engaged such that the rotation of the drive wheel 156 causes the clutch spring 136 to rotate in the clutch mechanism 170, thereby causing the lead screw 135 to advance the plunger 134 into the reservoir 126 from which fluid is delivered. In an alternative embodiment, the reservoir 126 may be filled when the plunger 134 is already retracted. In the illustrated embodiment, the drive wheel 156 may comprise one or more ratchets 186 that engage with an actuator to incrementally drive the drive wheel 156, advancing the plunger 134 across the reservoir 126.

[0038] In some embodiments, as shown in Figures 3A-3B, the clutch spring 136 of the clutch mechanism 170 may be a helical torsion spring located in a counterbore 172 (Figure 3B) at one end of the drive wheel 156. The ID of the clutch spring 136 may be greater than the outer diameter of the lead screw 135 when the clutch spring 136 is loaded, thereby allowing the clutch spring 136 to disengage from the lead screw 135 and the lead screw 135 to pass through the central opening of the clutch spring 136 and enter the elongated bore 174 of the drive wheel 156. Alternatively, the ID of the clutch spring 136 may be smaller than the outer diameter of the lead screw 135 when the clutch spring 136 is not loaded, thereby engaging with or gripping the lead screw 135, allowing the drive wheel 156 to rotate the lead screw 135. In some embodiments, the clutch spring 136 engages with the external thread 138 of the lead screw 135.

[0039] In the illustrated embodiment, before the reservoir 126 is filled, the clutch spring 136 can be held in a loaded disengaged position by a spring latch 164 engaged with the drive wheel 156. After the reservoir 126 is filled, the clutch spring 136 is engaged by rotating the drive wheel 156 until the spring latch 164 releases the clutch spring 136, thereby allowing the clutch spring 136 to be released and grip the lead screw 135. Subsequently, the fluid can be discharged from the reservoir 126 by the continued rotation of the drive wheel 156.

[0040] In some embodiments, the spring latch 164 can be biased by the clutch spring 136 as follows: as the drive wheel 156 rotates, the spring latch 164 rotates relative to the surface of the reservoir cap 175, and the clutch spring 136 biases the spring latch 164 so that it enters the window 176 of the reservoir cap 175. When the spring latch 164 moves into the window 176, the first end 178 (Figure 3A) of the clutch spring 136, held by the spring latch 164, is released and engages with the clutch mechanism 170. When the clutch spring 136 is engaged, the drive wheel 156 contacts the second end 179 of the clutch spring 136, generating thrust in the clutch spring 136, thereby causing the clutch spring 136 to rotate the lead screw 135.

[0041] Moving on to Figures 4A-4B, the operation of the clutch spring 136 and lead screw 135 according to another embodiment is described. In this embodiment, the clutch spring 136 may be coupled to the inner surface of the slider 184 or extend along it. The slider 184 may be a cylinder coupled to a plunger (not shown). This embodiment can reduce the required length of the entire drive system (particularly the clutch mechanism) by about half, thereby reducing the overall size of the drive mechanism. In addition, since a tube nut is not required in this drive mechanism, the overall number of parts and complexity of the system are reduced. In other preceding drive mechanisms, a tube nut was placed between the spring and the lead screw and used to convert the rotational motion of the rotary drive member into the translational motion of the lead screw. Such a tube nut typically extends along most of the length of the lead screw, thereby increasing the required length of the clutch mechanism and thus the entire drive system to about twice the length of the lead screw. Furthermore, the drive member could also rotate the lead screw via two components, namely the spring and the tube nut. In the advances disclosed herein, such tube nuts are eliminated, and the springs are modified so that they engage directly with the lead screw. As described above, this reduces the required length of the entire drive system, overcoming the "double length" problem, and also reduces the number of components required for the drive system and clutch mechanism.

[0042] As described above, the clutch spring 136 may initially be in a load configuration where its ID is greater than the OD of the lead screw 135, allowing the slider 184 to move freely along the lead screw 135 when the reservoir is filled. When the clutch spring 136 is released, it causes a decrease in the ID of the clutch spring 136, and consequently the engagement of the clutch spring 136 and the slider 184 with the lead screw 135. After the release of the clutch spring 136, the slider 184 functions like a drive nut, while the clutch spring 136 functions as an internal thread cutter, engaging with the threads on the OD of the lead screw 135 and / or following them. In this way, the rotation of the clutch spring 136 results in linear motion of the lead screw 135 and the plunger, allowing the drive mechanism to precisely discharge the fluid from the reservoir.

[0043] Figures 5A–5C show non-limiting examples of clutch springs 136 described herein. As shown, each clutch spring 136 may comprise a helical body 189 between a first end 178 and a second end 179. The body 189 may define a central opening 191, which is operable to receive a lead screw. The body 189 may comprise a plurality of loops or spirals 192 operable to engage with recesses in the external threading of the lead screw. Non-limitingly, the clutch spring 136 may have a circular, elliptical or oval cross-section (Figure 5A), a square or rhombic profile (Figure 5B), or a triangular profile (Figure 5C). Non-circular profiles can be used to form a geometry of the mating screw shape, complementary to the external threading of the lead screw 135.

[0044] Figure 6 shows an exemplary process 300 according to an embodiment of the present disclosure. In block 301, the process 300 may include providing a reservoir configured to contain a liquid agent, wherein the reservoir comprises a housing, the housing comprising an outer wall defining an internal chamber.

[0045] In block 302, process 300 may include providing a drive mechanism for releasing a liquid agent from a reservoir. In some embodiments, the drive mechanism may comprise a plunger received within an internal chamber of the reservoir, a feed screw extending from the plunger, and a drive wheel coupled to the feed screw and operable with a clutch mechanism. The plunger may form a seal against the inner surface of the outer wall of the housing.

[0046] In block 303, process 300 may further include rotating a clutch spring of a clutch mechanism to advance the lead screw. The clutch mechanism is configured such that, when in the disengaged position, the lead screw passes over the clutch spring, and when in the engaged position, it grips the lead screw. In some embodiments, process 300 may further include rotating a drive wheel to rotate the clutch spring and advance the lead screw and plunger into the reservoir. In some embodiments, the clutch spring may be provided such that it is in direct physical contact with the outer portion of the lead screw when the clutch spring is engaged with the lead screw. In some embodiments, rotating the drive wheel causes the plunger to discharge fluid from the reservoir.

[0047] In some embodiments, process 300 may include engaging and disengaging the clutch spring with the spring latch. In some embodiments, the clutch mechanism may be released from the disengaged position by disengaging the clutch spring from the spring latch by rotating the drive wheel.

[0048] As used herein, an algorithm or computer application for managing blood glucose levels and insulin therapy may be referred to as an “artificial pancreas” algorithm-based system, or more generally, an artificial pancreas (AP) application. An AP application may be programming code stored in a memory device and executable by a processor, controller, or computer device.

[0049] The technologies described herein relating to a drug delivery system (e.g., System 100 or any component thereof) may be implemented in hardware, software, or any combination thereof. The components described herein may be implemented in hardware, software, or any combination thereof. For example, System 100 or any component thereof may be implemented in hardware, software, or any combination thereof. Software-related implementations of the technologies described herein may include, but are not limited to, firmware, application-specific software, or any other type of computer-readable instruction that can be executed by one or more processors. Hardware-related implementations of the technologies described herein may include, but are not limited to, integrated circuits (ICs), ASICs, FPGAs, and / or PLDs. In some examples, the technologies described herein, and / or any systems or components described herein, may be implemented using processors that execute computer-readable instructions stored on one or more memory elements.

[0050] Some examples of the disclosed devices, when executed by a machine (i.e., a processor or controller), may be implemented using a storage medium, computer-readable medium, or product capable of storing instructions or sets of instructions, which can cause the machine to perform the methods and / or operations according to the examples of the Disclosure. Such a machine may include, for example, any suitable processing platform, computing platform, computing device, processing device, computing system, processing system, computer, processor, or similar, and may be implemented using any suitable combination of hardware and / or software. Computer-readable media or articles may include, for example, any suitable type of memory unit, memory, memory article, memory medium, storage device, storage article, storage medium and / or storage unit, such as memory (including non-temporary memory), removable or non-removable media, erasable or non-erasable media, writable or rewritable media, digital or analog media, hard disk, floppy disk, CD-ROM, CD-R, CD-RW, optical disk, magnetic disk, magneto-optical media, removable memory card or disk, various DVDs, tapes, cassettes, or similar. The above instructions may include any suitable type of code, such as source code, compiled code, interpreted code, executable code, static code, dynamic code, encrypted code, programming code, and similar. These are implemented using any suitable programming language, namely high-level, low-level, object-oriented, visual, compiled, and / or interpreted. Programming code, embodied in a non-temporary computer-readable medium, can cause a processor to perform functions as described herein when the programming code is executed.

[0051] Specific examples of the subject matter of this disclosure have been described above. However, it should be explicitly stated that the subject matter of this disclosure is not limited to those examples. Rather, the intention is that additions and modifications to those expressly described herein also fall within the scope of the subject matter of this disclosure. Furthermore, it should be understood that the features of the various examples described herein are not mutually exclusive and may exist in various combinations and orders, and that even if such combinations or orders are not expressly described herein, they may exist without departing from the spirit and scope of the subject matter of this disclosure. In fact, variations, modifications, and other implementations of those described herein will be conceivable to those skilled in the art without departing from the spirit and scope of the subject matter of this disclosure. Thus, the subject matter of this disclosure is not defined solely by the above exemplary descriptions.

[0052] The programmatic aspects of this technology can typically be considered as a “product” or “manufactured product” in the form of executable code and / or associated data executed or embodied within some kind of machine-readable medium. Storage media include any or all tangible memory, namely any or all tangible memory of a computer, processor, or similar device, or any or all tangible memory of modules associated therewith, such as various semiconductor memories, tape drives, disk drives, or similar modules, capable of providing non-temporary storage at any time for software programming. It should be emphasized that this summary of the disclosure is provided to enable readers to quickly grasp the essence of the technical disclosure. This summary is submitted with the understanding that it is not intended to interpret or limit the scope or meaning of the claims. In addition, in the modes for carrying out the prior invention, various features are grouped together in a single example for the sake of streamlining the disclosure. This method of disclosure should not be interpreted as reflecting an intention that the claimed example requires more features than those explicitly described in each claim. Rather, as reflected in the following claims, the progressive subject matter lies in fewer features than all the features of a single disclosed example combined. Thus, the following claims are incorporated into a mode for carrying out the invention herein, and each claim stands alone as a distinct example. In the appended claims, the terms “including” and “in which” are used as plain English equivalents of “equipped with” and “wherein,” respectively. Furthermore, terms such as “first,” “second,” and “third” are used merely as labels and are not intended to impose numerical requirements on their subjects.

[0053] The above description of embodiments is provided for illustrative and explanatory purposes only. It is not intended to be exhaustive or to limit the disclosure to the very form disclosed. Many modifications and variations are possible in light of the disclosure. The scope of the disclosure is intended to be limited not by this detailed description, but rather by the claims attached thereto. Future applications claiming priority to this application may claim the subject matter of the disclosure in different ways and may generally include any set of one or more limitations as variously disclosed or otherwise demonstrated herein.

Claims

1. A wearable drug delivery device, wherein the wearable drug delivery device, A reservoir configured to contain a fluid, the reservoir comprising a housing defining an internal chamber, The system includes a drive mechanism for releasing the fluid from the reservoir, and the drive mechanism is The plunger in the internal chamber of the reservoir, A feed screw extending from the plunger, A wearable drug delivery device comprising: a clutch mechanism engaged with the lead screw, wherein the clutch mechanism is configured such that when disengaged, the lead screw can pass through the clutch mechanism, and when engaged, it grips the lead screw so that the clutch mechanism rotates and advances the lead screw and the plunger in the reservoir, and the clutch mechanism is equipped with a clutch spring, the clutch spring being in direct physical contact with the outer part of the lead screw when the clutch mechanism is engaged with the lead screw.

2. The wearable drug delivery device according to claim 1, wherein the clutch mechanism further comprises a spring latch, the spring latch being operable to hold the clutch spring in the disengaged position and configured to release the clutch spring so that the clutch spring moves to the engaged position.

3. The wearable drug delivery device according to claim 2, wherein the spring latch is operable to release the clutch spring in response to the movement of the drive wheel.

4. The wearable drug delivery device according to claim 1, further comprising a slider connected to the clutch spring.

5. The wearable drug delivery device according to claim 4, wherein the clutch spring is provided along the inner part of the slider.

6. The wearable drug delivery device according to claim 1, wherein the clutch spring has a square profile, a triangular profile, or an elliptical profile.

7. The wearable drug delivery device according to claim 1, further comprising a drive wheel, the drive wheel being operable with the clutch mechanism to rotate and advance the lead screw.

8. A wearable drug delivery device, wherein the wearable drug delivery device, A reservoir configured to contain a liquid drug, the reservoir comprising a housing, the housing including an outer wall defining an internal chamber, The system includes a drive mechanism for releasing the liquid drug from the reservoir, and the drive mechanism is The plunger in the internal chamber of the reservoir, A feed screw extending from the plunger, A wearable drug delivery device comprising: a drive wheel operable with a clutch mechanism to rotate a clutch spring to advance the lead screw, wherein the clutch mechanism is configured such that when in the disengaged position, the lead screw can pass over the clutch spring, and when in the engaged position, the drive wheel is configured to grip the lead screw with the clutch spring so as to rotate the clutch spring and advance the lead screw and plunger into the reservoir, and the clutch spring is in direct physical contact with the outer part of the lead screw when the clutch mechanism is in the engaged position.

9. The wearable drug delivery device according to claim 8, wherein the clutch mechanism further comprises a spring latch operable to engage with and disengage the clutch spring.

10. The wearable drug delivery device according to claim 9, wherein the spring latch is operable to release the clutch spring in response to the movement of the drive wheel.

11. The wearable drug delivery device according to claim 8, further comprising a slider connected to the clutch spring, wherein the clutch spring is provided along the inner part of the slider.

12. The wearable drug delivery device according to claim 8, wherein the clutch spring has a square profile, a triangular profile, a circular profile, or an elliptical profile.

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