Single actuation precision dosing intermediate pumping chamber

Abstract

Examples of devices, systems, and techniques for delivering liquid medicaments are disclosed. An example delivery pump device can include a chamber body defining a pump chamber, an inlet valve to receive a liquid medicament, and a hard stop. A plunger is configured with a plunger channel. A sliding fluidic member includes a needle coupling, a flow orifice, a face seal, and an anchored portion that can move within the pump chamber. A pump mechanism can be coupled to the anchored portion and operable to pull the anchored portion and the plunger toward the hard stop. Techniques can include determining a time to output a liquid medicament from a delivery pump device, generating a control signal to actuate the delivery pump device, applying the control signal to the pump mechanism, determining that the control signal is to be removed from the pump mechanism, and delivering the liquid medicament.

Description

[0001] Cross-references to related applications

[0002] This application claims the benefit of U.S. Provisional Patent Application US63 / 135,081, filed January 8, 2021, the contents of which are incorporated herein by reference in their entirety. Technical Field

[0003] The disclosed examples generally relate to drug delivery. More specifically, the disclosed examples relate to techniques, processes, systems, and pump assemblies for providing a fixed volume of fluid delivered and refilled within a pumping cycle. Background Technology

[0004] Many drug delivery devices include a reservoir for storing liquid medication, and a pump mechanism operated to displace the stored liquid medication from the reservoir to deliver it to the user. The pump mechanism may be a positive displacement pump that dispenses a dose of medication from the reservoir and pushes it to the patient via valve regulation or reciprocating motion. Other conventional pumps include, but are not limited to, diaphragm pumps, rotary pumps, vane pumps, screw / turbine pumps, or other types of conventional pumps. Some conventional drive mechanisms use a plunger to displace the liquid medication from the reservoir, which may result in the drive mechanism being approximately equal in length to the reservoir.

[0005] Due to the mechanical "sticking" or "slipping" of the pump mechanism, various pump mechanism configurations may result in nominal under- or over-delivery of liquid drug doses over time.

[0006] Therefore, there is a need for a simplified system for accurately discharging liquid drugs from a reservoir, which also reduces the overall size of the drug delivery device. Summary of the Invention

[0007] This summary is provided to introduce, in a simplified form, the selection of concepts which will be further described in the detailed description below. This summary is not intended to identify key or essential features of the claimed subject matter, nor is it intended to help determine the scope of the claimed subject matter.

[0008] In some aspects, a wearable drug delivery device including a reservoir and a delivery pump assembly is disclosed. The reservoir can be configured to store a liquid drug. The delivery pump assembly can be coupled to the reservoir for receiving the liquid drug from the reservoir. The delivery pump assembly may include: a chamber body defining a pump chamber; an inlet port configured to allow the liquid drug to be drawn from the reservoir into the pump chamber; a sliding fluid member including a flow orifice and a fluid path to a needle; a plunger including a plunger channel configured to engage with the sliding fluid member; and a shape memory alloy wire coupled to the sliding fluid member. The shape memory alloy wire is operable to draw the liquid drug from the reservoir through the inlet port into the pump chamber by pulling the sliding fluid member and the plunger along a first direction. The sliding fluid member is configured to allow the liquid drug to be drawn into the pump chamber and discharged from the pump chamber into the fluid path to the needle for output.

[0009] In another aspect, a delivery pump device for a wearable drug delivery device is provided. The delivery pump device includes a chamber body, a plunger, a sliding fluid member, and a shape memory alloy wire. The chamber body defines a pump chamber and includes a rigid stop and an inlet valve, and is operable to receive liquid drug from a reservoir. The plunger is movable within the pump chamber of the chamber body and is configured with a plunger channel. The sliding fluid member is movable within the pump chamber and includes a needle coupling, a flow orifice, a face seal, and an anchoring portion. The anchoring portion is positioned in a leak-proof configuration within the plunger channel and is movable within the plunger channel. The shape memory alloy wire can be coupled to the anchoring portion. The shape memory alloy wire is operable to pull the anchoring portion and the plunger toward the rigid stop.

[0010] In another aspect, a method for controlling a delivery pump device to dispense liquid medication is disclosed. The method includes determining the time for dispensing liquid medication from the delivery pump device. A control signal can be generated to actuate the delivery pump device. The control signal can be applied to the pump mechanism of the delivery pump device. The pump mechanism includes a shape memory alloy wire configured to respond to the applied control signal. As the pump chamber of the delivery pump device is filled with liquid medication, it is determined that the applied control signal will be removed from the pump mechanism of the delivery pump device. The applied control signal can be removed from the pump mechanism to enable the delivery of liquid medication from the pump chamber. The delivery of the liquid medication can be confirmed. Attached Figure Description

[0011] In the accompanying drawings, the same reference numerals generally refer to the same parts in different views. In the following description, various examples of this disclosure will be described with reference to the following drawings, in which:

[0012] Figure 1 A schematic diagram of a drug delivery system according to an example of this disclosure is shown.

[0013] Figure 2 A side sectional view of the intermediate pumping chamber of the delivery pump unit in the initial state of the pumping cycle is shown.

[0014] Figure 3A It shows that it is in the state of being from Figure 2 The example shows a side sectional view of the intermediate pumping chamber of a delivery pump unit that transitions to the initial state of the pumping cycle in the intermediate pumping chamber.

[0015] Figure 3B An exemplary filling area of ​​an exemplary pump chamber is shown.

[0016] Figure 4 A cross-sectional view of an exemplary intermediate pumping chamber in a filled state before liquid drugs are delivered from the pumping chamber is shown.

[0017] Figure 5 It shows from Figure 4 A cross-sectional view of an exemplary intermediate pumping chamber transitioning from a filled state to a delivery-ready state.

[0018] Figure 6 A cross-sectional view of an exemplary intermediate pumping chamber is shown, in which liquid drugs are being delivered from the pumping chamber.

[0019] Figure 7 A cross-sectional view of an exemplary intermediate pumping chamber is shown in the state of the plunger moving to deliver liquid medicine from the pumping chamber.

[0020] Figure 8 A cross-sectional view of another example architecture of the intermediate pumping chamber is shown.

[0021] Figure 9 It shows that it is in the state of being from Figure 8 The example shows a side sectional view of the intermediate pumping chamber of a delivery pump unit that transitions to the initial state of the pumping cycle in the intermediate pumping chamber.

[0022] Figure 10 This shows the state of being filled before the liquid drug is delivered from the pump chamber. Figure 9 A side sectional view of the intermediate pumping chamber in the example.

[0023] Figure 11 It shows from Figure 4 The example is a cross-sectional view of an exemplary intermediate pumping chamber, showing the transition from a filling state to a delivery state where liquid medication is delivered from the pumping chamber via the movement of a plunger.

[0024] Figure 12 Exemplary configurations of electrical contacts for various control aspects of a delivery pump device are shown.

[0025] Figure 13 It can be utilized Figures 1 to 12 The flowchart illustrates the process of discharging drugs from a delivery pump device.

[0026] The accompanying drawings are not necessarily drawn to scale. The drawings are schematic only and are not intended to describe specific parameters of this disclosure. The drawings are intended to depict examples of this disclosure and are therefore not to be considered limiting. Furthermore, for clarity, some elements in some drawings may be omitted, or some elements may not be shown to scale. Additionally, for clarity, some reference numerals may be omitted in some drawings. Detailed Implementation

[0027] Systems, apparatuses, and methods according to this disclosure will now be described more fully below with reference to the accompanying drawings, in which one or more examples are illustrated. Systems, apparatuses, and methods may be embodied in many different forms and should not be construed as limited to the examples set forth herein. Rather, these examples are provided to make this disclosure thorough and complete, and to fully convey the scope of the methods and apparatuses to those skilled in the art. Each of the systems, apparatuses, and methods disclosed herein offers one or more advantages over conventional systems, components, and methods.

[0028] The pump mechanism described herein is intended to have the aforementioned advantageous features. Furthermore, the pump mechanism is configured to output a predetermined amount of liquid medication during each "pulse" of the pump, which assumes that the displacement members of the pump mechanism travel from their "start" limits to their "stop" limits. The travel of the pump mechanism may be referred to as a "pump stroke" and may have a variable travel distance. In some examples, the pump stroke may be adjustable or may have a preset distance. A "pulse" can be considered as the pump responding to an actuation of a control signal, during which a dose of liquid medication is output from the reservoir of the wearable drug delivery device.

[0029] Figure 1 A simplified block diagram of an exemplary system 100 is shown. System 100 may be a wearable or on-the-skin drug delivery device configured to attach to the skin of a patient 103. System 100 may include a controller 102, a pump mechanism 104 (also referred to as "pump 104"), and a sensor 108.

[0030] Sensor 108 may be an analyte sensor operable to detect ketones, lactate, uric acid, alcohol, and glucose, etc. For example, sensor 108 may be a glucose monitor, such as a continuous glucose monitor. Sensor 108 may, for example, be operable to measure a user's blood glucose (BG) value to generate a measured BG level signal 112. Controller 102, pump 104, and sensor 108 may be communicatively coupled to each other via a wired or wireless communication path. For example, each of controller 102, pump 104, and sensor 108 may be equipped with a wireless radio frequency transceiver operable via one or more communication protocols (such as...). The system 100 may also include a delivery pump assembly (also referred to as the “device”) 105, which includes a housing 114 defining an intermediate pumping chamber 115, an inlet port 116, and an outlet port 117. The system 100 may include additional components that are not shown or described for the sake of brevity.

[0031] In this example, controller 102 may receive a desired BG level signal indicating a desired BG level or BG range for patient 103. This desired BG level signal may be received, for example, from a user interface (not shown) connected to controller 102 or another device, or via an algorithm that automatically determines the ideal BG level for patient 103. Sensor 108 may be coupled to patient 103 and operable to measure an approximate value of the user's BG level. In response to the measured BG level or value, sensor 108 may generate a signal indicating the measured BG value. As shown in this example, controller 102 may also receive the measured BG level signal 112 from sensor 108 via a communication path.

[0032] Based on the desired BG level signal and the measured BG level signal 112, the controller 102 can generate one or more control signals to guide the operation of the pump 104. For example, a control signal 119 from the controller 102 can cause one or more electrical components 123 to be operably connected to the delivery pump assembly 105 for starting or activation. (See reference...) Figures 2 to 13 As described in the example, the electrical element 123 can activate the SMA wire (not shown in this example) within the intermediate pumping chamber 115. In response, the SMA wire can change shape and / or length, which in turn can change the configuration of the intermediate pumping chamber 115.

[0033] In response to a pressure change due to a change in the configuration of the intermediate pump chamber 115, a certain amount of liquid medication 125 (e.g., insulin) can be drawn into the intermediate pump chamber 115 through the inlet port 116. For example, the amount of liquid medication 125 can be determined based on the difference between the desired BG level signal and the actual BG signal level 112. The amount of liquid medication 125 can be determined as an appropriate amount of insulin to drive the user's measured BG level to the desired BG level. Based on the operation of the pump 104 as determined by the control signal 119, the patient 103 can receive the liquid medication from the reservoir 126 via a pulse sequence. The system 100 can operate as a closed-loop system, an open-loop system, or a hybrid system.

[0034] As further shown, system 100 may include a needle deployment component 128 that communicates with controller 102. Needle deployment component 128 may include a needle / cannula 129 that can be deployed into patient 103. Cannula 129 may form part of a fluid path connecting patient 103 to reservoir 126.

[0035] As further shown, outlet port 117 can be coupled to cannula 129. Intermediate pump chamber 115 is coupled via outlet port 117 to a needle / cannula connector (shown in another figure) that allows fluid to be transferred from reservoir 126 to cannula 129. Cannula 129 can be configured to allow fluid discharged from delivery pump assembly 105 to be supplied to patient 103.

[0036] Controller 102 can be implemented in hardware, software, or any combination thereof. Controller 102 can be, for example, a processor, logic circuitry, or microcontroller coupled to memory 106. Memory 106 may include logic 106-1 and settings 106-2. Controller 102 can maintain date and time and perform various functions (e.g., calculations, etc.) that can be used to determine the condition or state of various components of the system. Controller 102 may be operable to execute algorithms, such as the Artificial Pancreas (AP) algorithm stored in memory 106 as logic 106-1, which may be operable to enable controller 102 to direct the operation of pump 104. Logic 106-1 can implement the operation of delivery pump device 105. For example, controller 102 may be operable to receive input from sensor 108, where the input corresponds to automated drug delivery (such as automated insulin delivery (AID) application settings), which controller 102 may utilize in the control of intermediate pump chamber 115. Based on the AID application settings, the controller 102 can modify the behavior of the pump 104 and the amount of liquid medication 125 produced to be delivered to the patient 103 via the delivery pump device 105.

[0037] In some examples, sensor 108 may be, for example, a continuous glucose monitor (CGM). Sensor 108 may be physically separate from pump 104, or it may be an integrated component within the same or adjacent housing of the pump. Sensor 108 may provide controller 102 with data indicating the user's measured or detected blood glucose levels.

[0038] The power element 123 may be a battery or a piezoelectric device, etc., for supplying power to the delivery pump assembly 105. In other examples, the power element 123 or an auxiliary power source (not shown) may also power other components of the pump 104, such as the controller 102, memory 106, sensor 108 and / or needle deployment component 128.

[0039] In one example, sensor 108 may be a device communicatively coupled to controller 102 and may be operable to measure blood glucose values ​​at predetermined time intervals (e.g., approximately every 5 minutes or 10 minutes). Sensor 108 may provide multiple blood glucose measurements to an AP application executed by controller 102 or an external control device.

[0040] In some examples, when operating in normal operating mode, pump 104 delivers insulin stored in reservoir 126 to patient 103 based on information provided by sensor 108 or other functional elements of pump 104 (e.g., blood glucose measurement, target blood glucose value, active insulin, previous insulin delivery, time of day, day of week, input from inertial measurement unit, input from GPS-enabled device, or input from Wi-Fi-enabled device, etc.). For example, pump 104 may include analog and / or digital circuitry, which may be implemented as controller 102 for controlling the delivery of medication or therapeutic agents. The circuitry used to implement controller 102 may include discrete dedicated logic and / or components, application-specific integrated circuits, microcontrollers, or processors that execute software instructions, firmware, programming instructions, or programming code, or any combination thereof, enabling, for example, an AP application stored in memory 106. For example, controller 102 can execute control algorithms and other programming code (such as an AP application) that enables controller 102 to operate such that pump 104 delivers a dose of medication or therapeutic agent to the user at predetermined intervals or as needed, so that blood glucose measurements reach a target blood glucose value or range. The dose size and / or timing can be pre-programmed into the AP application, for example, by the patient 103 or by a third party (such as a healthcare provider, parent or guardian, or manufacturer of wearable medication delivery devices, etc.) using a wired or wireless link. The AP application can also be operable to automatically adjust any pre-programmable settings (such as insulin dose limits and the number of strokes or pulses to be delivered) based on data received from sensors 108 or detectors (shown in another figure) within intermediate pump chamber 115. Controller 102 can be coupled to intermediate pump chamber 115 via communication path 188. Controller 102 can transmit control signals to components of intermediate pump chamber 115 (shown in other examples).

[0041] Although not shown, in some examples, sensor 108 may include a processor, memory, sensing or measuring devices, and communication devices (not shown in this example). The memory may store, for example, AP applications and other programming code, and is operable to store data related to the AP applications.

[0042] In various examples, the sensing / measuring device of sensor 108 may include one or more sensing elements, such as a blood glucose measuring element, a heart rate monitor, or a blood oxygen sensor element. In one example, the sensor's processor may include discrete dedicated logic and / or components, application-specific integrated circuits, microcontrollers, or processors that execute software instructions, firmware, programming instructions stored in memory, or any combination thereof.

[0043] Figure 2It shows the initial position. Figure 1 A side sectional view of the intermediate pump chamber of an example wearable drug delivery system. The intermediate pump chamber 200 may have a front portion 200a and a rear portion 200b and is connected to a reservoir containing liquid drug via a reservoir connector 201. The intermediate pump chamber 200 may be operable to change its configuration during operation. For example, Figure 2 The initial position can be a position where the liquid drug from the reservoir has not yet been drawn into the pump chamber (shown in more detail in another figure). Components of an exemplary intermediate pump chamber 200 may include a sliding fluid member 1, a chamber body 10, and a plunger 3. Additional components may include a valve 2 (such as a passive check valve), a plunger spring 4, a fluid member (FM) spring 5, a shape memory alloy (SMA) wire 6, a hard stop 7, and a face seal 11. Figure 1 The inlet port 116 can be formed by a passive check valve 2 and is configured to allow liquid medication to be drawn from the reservoir into the pump chamber (shown in more detail in another figure). The plunger spring 4 and FM spring 5 can be compression springs. When the intermediate pumping chamber 200 is in this initial position, the FM spring 5 and plunger spring 4 are shown as (in...) Figure 2 (In the middle) is in its rest position. Of course, other types of springs or other types of devices can be used instead of the spring in the exemplary intermediate pumping chamber 200.

[0044] In this example, such as Figure 2 The position of the sliding fluid member 1 shown can be considered as a rest position or an initial position. The sliding fluid member 1 may be configured with an anchoring portion 1a, a needle / cannula connector 1b, and a flow orifice 12. The needle / cannula connector 1b may be configured, for example, as a hollow member to provide a fluid path 16 to the needle / cannula (not shown in this example). The sliding fluid member 1 may include a flow orifice 12 constructed within the sliding fluid member 1, between the anchoring portion 1a and the needle / cannula connector 1b. For example, the sliding fluid member 12 may include the flow orifice 12 and a fluid path 16 to the needle. The sliding fluid member 1 may be coupled to, for example,... Figure 1 The needle or cannula 129. The anchoring portion 1a may include a structure connecting the anchoring portion 1a to the needle / cannula connector 1b (not shown in this example for clarity). The needle / cannula connector 1b may be configured to remain connected to the needle / cannula (not shown in this example) and extend into the chamber body 10. For example, the needle / cannula connector 1b may be a resilient member, a multi-segment leak-proof extendable tube, or a combination thereof. The flow orifice 12 may be surrounded by a structure that connects the needle / cannula connector 1b to the anchoring portion 1a but allows liquid medication to enter the flow orifice 12 when in the pump chamber and to the needle / cannula (e.g., Figure 1 The fluid flows in the fluid path 16 (as shown).

[0045] In the exemplary intermediate pumping chamber 200, the passive check valve 2 can be configured to respond when the pumping chamber is filled with water from a reservoir (such as...). Figure 1 Prevent backflow of liquid medication when handling liquid medication (shown in the examples / figures below).

[0046] The plunger 3 can be configured to form a leak-proof seal on the side of the abutment chamber body 10. As shown in the later examples, the plunger 3 is operable to draw liquid medication from a reservoir and deliver the liquid medication through a fluid path 16 leading to a needle or cannula (not shown in this example). The rear surface 200b of the plunger 3 facing the intermediate pumping chamber 200 can be coupled to or abutment against the plunger spring 4. The plunger spring 4 can be, for example, a... Figure 2 The compression spring shown is in a stationary state. The end of the plunger spring 4 opposite to the plunger 3 can be connected to the hard stop 7 or rest against the hard stop 7.

[0047] In this example, the plunger 3 is configured with a plunger channel 3a and a plunger flexure latching portion 9. The plunger channel 3a may be a hollow central portion in which the anchoring portion 1a of the sliding fluid member 1 is fitted. The plunger channel 3a may be configured to surround the anchoring portion 1a of the sliding fluid member 1. The interface between the plunger channel 3a and the anchoring portion 1a is leak-proof, but the anchoring portion 1a is configured to slide back and forth through the plunger channel 3a. The plunger flexure latching portion 9 is flexible and may extend along the surface of the anchoring portion 1a of the sliding fluid member 1 and terminate in a bulbous portion (or, in another embodiment, a concave body or a portion complementary to the rigid stop flexure latching portion 8).

[0048] A face seal 11 may be disposed between the anchoring portion 1a of the sliding fluid member 1 and the needle / cannula connection 1b and at the periphery of the flow orifice 12. The face seal 11 may be operable to provide a leak-proof seal for the flow orifice 12, limiting any leakage of liquid medication through or around the flow orifice 12 into the fluid path 16 leading to the needle or cannula. The face seal 11 may be configured to prevent liquid medication from flowing to the patient when the intermediate pump chamber is in its initial position. During some phases of operation, the face seal 11 may be under pressure, for example, from the plunger spring 4 of the intermediate pump chamber 200, which prevents any liquid medication from entering the fluid path 16.

[0049] SMA wire 6 can be nitinol or other known shape memory alloy wire, operable to change its length or shape in response to the application of current. For example, SMA wire 6 can be connected to a power source via a circuit, responding to a controller (such as...) Figure 1When a control signal (as shown) is actuated, the circuit is configured to apply current or voltage to actuate the SMA wire 6.

[0050] The rigid stop 7 can be configured to restrict the movement of the plunger 3. The rigid stop 7 can be configured to include two rigid stop flexures 8a, which are configured to extend from the rigid stop 7 toward the front portion 200a of the intermediate pumping chamber 200. In the exemplary intermediate pumping chamber 200, each of the two rigid stop flexures 8a may include a rigid stop flexure latch 8 at the end of the rigid stop flexure 8a closest to the plunger 3. In this example, the rigid stop flexure latch 8 is two flexible arm-like structures, wherein each flexible arm-like structure has an inwardly facing cavity at its respective end (or, in another embodiment, a protrusion or a portion complementary to the plunger flexure latch 9). Although two rigid stop flexure latches 8 are shown, the number of rigid stop flexure latches 8 can be more or less, such as 1, 3, or 4, and in other examples, more or fewer plunger flexure latches 9 can be used to engage the plunger 3. The interaction between the rigid stop flexure latch 8 and the plunger flexure latch 9 is described in more detail in the following examples.

[0051] Figure 3A A side sectional view of the intermediate pumping chamber transitioning from its initial position to the filling stage is shown.

[0052] exist Figure 3A The diagram shows an intermediate pumping chamber 200 responding to the operation of filling liquid drug 20 from a reservoir via a reservoir coupling 201. An SMA cable 6 is coupled to the anchoring portion 1a and circuitry (not shown in this example) in response to a signal from a controller (as shown in the previous example).

[0053] In response to actuation, the SMA wire 6 can be pulled on the anchoring portion 1a of the sliding fluid member 1, which pulls the plunger 3 in the direction indicated by arrow A. Pulling the SMA wire 6 in the direction of arrow A causes the sliding fluid member 1 and the plunger 3 to be pulled away from the front surface 205 of the intermediate pumping chamber 200 and away from the passive check valve 2. The pulling action of the SMA wire 6 on the anchoring portion 1a creates a vacuum in the pump chamber 22. This vacuum causes the passive check valve 2 to open in the same direction as the movement of the sliding fluid member 1 and the plunger 3 (as indicated by the unnumbered arrow on the passive check valve 2), and allows the pump chamber 22 to be filled with liquid drug 20 from the reservoir via the reservoir coupling 201.

[0054] During this filling phase, due to the compression of the fluid component spring 5 (e.g., F = -kx, where F is the force, k is the spring constant, and x is the distance the spring is compressed from its rest position), the face seal 11 acts with a large force (against the first plunger surface 3c of the plunger 3) on the flow orifice 12. The position of the hard stop 7 relative to the front surface 205 of the intermediate pumping chamber 200 can be varied under strictly controlled conditions, allowing for adjustment of the pump stroke, or alternatively, the position of the hard stop 7 can be configured at the factory for a preset pump stroke. The length of the SMA wire 6 can be configured based on the adjustment or setting of the plunger's pump stroke and the position of the hard stop 7 to achieve the correct amount of pump stroke.

[0055] exist Figure 3A In the example, the plunger 3 and the sliding fluid member 1 translate rearward toward the rear portion 200b of the intermediate pumping chamber 200. As the plunger 3 and the sliding fluid member 1 translate rearward, the rigid stop flexure 8a and the plunger flexure latching portion 9 interact. The plunger flexure latching portion 9 is provided with a semi-circular protrusion that, when contacted by the rigid stop flexure 8a, causes the rigid stop flexures 8a on both sides of the rigid stop 7 to open toward the corresponding sides of the chamber body 10. As the rigid stop flexures 8a separate, the semi-circular protrusion on the plunger flexure latching portion 9 fills the rigid stop flexure latching portion 8a, which is a recess in the rigid stop flexure 8a of the rigid stop 7. This results in a bidirectional latch / lock that prevents the sliding fluid member 1 and the plunger 3 from translating further rearward toward the rear portion 200b of the intermediate pumping chamber 200.

[0056] Figure 3B It shows Figure 3A An example of the effective flow region in the pump chamber. (See example.) Figure 3BAs shown in the example, the effective flow region 33 can be an annular space. An annular effective flow region 33 allows for the use of larger components, such as the plunger 3, the sliding fluid member 1, and the intermediate pumping chamber 10, which facilitates component manufacturing and assembly. For example, the annular effective flow region 33 can be a result of using cylindrical structures that are easier to manufacture and assemble, such as cylindrical plungers and cylindrical chamber bodies 10 (shown in an earlier example). Of course, other shapes, such as oval, rectangular, or square shapes, can be used. For example, a ratio between d1 and d2 can be established to allow for dimensional control of the effective flow region 33. This dimensional control facilitates increasing the ratio of the pump chamber size to the plunger size, allowing manufacturing tolerances to be a small or minimal percentage of the actual size of the delivery pump assembly 105. By controlling those dimensions d1 and d2, a desired pump chamber volume can be achieved. Given a small pump volume, the larger the pump chamber and plunger, the closer the pump chamber and plunger will be to their nominal dimensions. The approximate area of ​​the effective flow region 33 can be determined using the following equation: [(d2 / 2)2×π]-[(d1 / 2)2×π]-(area of ​​the flow orifice 12 extending beyond d1), where d2 is the diameter of the plunger 3 and d1 is the diameter of the sliding fluid member 1.

[0057] exist Figure 4 In the middle, the intermediate pump chamber 200 has reached its full stroke, the pump chamber 22 is filled with liquid drug 20, and the passive check valve 22 has closed as the pressure has essentially returned to approximately 0 psig. Both the plunger spring 4 and the FM spring 5 are compressed and store energy. In this example, the plunger flexure latch 9 is operable to perform several actions, such as when the liquid drug 20 is dispensing from the reservoir (i.e., Figure 1 When the 126) is drawn into the pump chamber 22, the stroke of the plunger 3 within the intermediate pumping chamber 200 is limited. The auxiliary SMA wire 6 maintains the energy stored in the plunger spring 4 and the FM spring 5, thereby preventing the plunger 3 from turning back toward the front surface 205 until the sliding fluid member 1 has reached a specific point in its stroke, etc. As further explained with reference to another figure, the plunger flexure latch 9 and the hard stop flexure latch 8 can provide electrical interfaces (e.g., electrical contacts on each of their surfaces), which, when connected to the control circuit, can be operated to confirm that the pump chamber 22 is full or that the delivery of liquid medication has begun. Figure 4 The position shown can be referred to as the full position or the loading position.

[0058] exist Figure 5 In response to the release of current from the SMA wire 6, the SMA wire 6 is de-energized and begins to return to its pre-actuated state. Additionally, the FM spring 5 directs the sliding fluid element 1 towards... Figure 2Push back from the initial position shown (as indicated by arrow B). Depending on the configuration of the SMA wire 6 and the FM spring 5, the SMA wire 6 can act as a brake on the FM spring 5 (and limit the force applied by the FM spring 5) to slow down the movement of the sliding fluid member 1 in the direction of arrow B. Alternatively, the SMA wire 6 can be configured to allow the FM spring 5 to apply its full force to the sliding fluid member 1.

[0059] As the sliding fluid member 1 moves toward the front surface 205, the flow orifice 12 is exposed because the face seal 11 is no longer in contact with the front surface of the plunger 3. In this example, the sliding fluid member 1 can move within the space of the pump chamber 22 without discharging too much liquid drug into the fluid path 16 if any movement is made.

[0060] Furthermore, as the sliding fluid member 1 moves toward the front surface 205, the plunger 3 remains stationary because the plunger flexure latch 9 and the hard stop flexure latch 8 are connected due to the support provided by the sliding fluid member 1.

[0061] In this example, when fully retracted into plunger 3 (as shown) Figure 3A As shown, the anchoring portion 1a of the sliding fluid member 1 supports the plunger flexure latching portion 9. The support provided by the sliding fluid member 1 to the plunger flexure latching portion 9 is used to keep the plunger flexure latching portion 9 connected to the rigid stop flexure latching portion 8.

[0062] However, as the sliding fluid component 1 along Figure 5 When the movement is in the direction of arrow B, the connection between the plunger flexure latch 9 and the hard stop flexure latch 8 becomes unstable.

[0063] Figure 6 The slack of the SMA wire 6 is shown, and the sliding fluid member 1 is shown to have reached its forward limit of travel due to impacting the inner side of the front of the intermediate pumping chamber 200 in response to the force applied to the anchoring part 1a by the FM spring 5.

[0064] Because of the lack of support provided by the anchoring portion 1a to the plunger flexure 9a, the plunger flexure 9a may be more prone to bending. Due to this lack of support, the rigid stop flexure 8a does not need to bend as much to disengage the corresponding plunger flexure latch 9 and the rigid stop flexure latch 8. The stroke of the corresponding rigid stop flexure latch 8 and the plunger flexure latch 9 is shown by arrows E and F. Figure 6As shown, the force exerted on the plunger 3 by the plunger spring 4 causes the plunger 3 to move in the direction indicated by arrow C, thereby creating instability at the connection between the corresponding plunger flexure latch 9 and the hard stop flexure latch 8. This instability allows the force of the plunger spring 4 to overcome the frictional force that holds the plunger flexure latch 9 and the hard stop flexure latch 8 together, causing the corresponding plunger flexure 9a and the hard stop flexure 8a to bend and thus release the plunger 3 to continue its journey toward the front of the intermediate pumping chamber 200.

[0065] In another example, the disengagement of the plunger flexure latch 9 and the hard stop flexure latch 8 also disrupts the electrical connection formed by the connected plunger flexure latch 9 and the hard stop flexure latch 8, which the controller can interpret as delivering the liquid drug to the fluid path 16 and to the user.

[0066] Figure 7 The movement of the plunger is shown to deliver liquid medication from pump chamber 22. Figure 7 In the example, plunger 3 is shown to compress pump chamber 22 under the force of plunger spring 4, discharging liquid medication 20 from pump chamber 22 through outlet orifice 12. Passive check valve 2 closes under the pressure of liquid medication 20 and prevents any liquid medication 20 from returning to the reservoir. The pump flow rate Q, a factor of spring stiffness, orifice diameter / length, and tubing size leading to the patient, is best described by Poiseuille's law, as follows:

[0067] Q flow P pressure r radius η fluid viscosity l pipe length

[0068]

[0069] When pump chamber 22 is fully retracted under the force of plunger spring 4, intermediate pumping chamber 200 returns to its original position. Figure 2 The initial position is shown, with the intermediate pumping chamber 200 at rest and ready to be re-energized for another pulse to deliver liquid medication to the user.

[0070] and Figures 2 to 7 In contrast to the illustrated embodiment, the plunger flexure latch 9 and the rigid stop flexure 8a, as well as the rigid stop flexure latch 8, can be optional because other devices limiting the stroke of the plunger 3 are also available. For example, in Figure 8 In this configuration, the intermediate pumping chamber can be hydraulically confined. Furthermore, in some configurations or applications (e.g., pumping applications with longer usage cycles than those for insulin delivery devices), the use of flexure clips may cause greater frictional losses, which may be unacceptable for prolonged use (e.g., more than one week).

[0071] Figure 8A side sectional view of another example of an intermediate pumping chamber in a wearable drug delivery system is shown. The intermediate pumping chamber 800 may have a front portion 800a and a rear portion 800b, and is coupled to a reservoir containing liquid drug via a reservoir connector 801. The intermediate pumping chamber 800 may be operable to change its configuration during operation. For example, Figure 8 The initial position can be a position where the liquid drug from the reservoir has not yet been drawn into the pump chamber (shown in more detail in later figures). The main components of an exemplary intermediate pump chamber 200 may include a sliding fluid member 815, a chamber body 880, and a plunger 820. Additional components may include a passive check valve 810, a plunger spring 830, a fluid member (FM) spring 840, a shape memory alloy (SMA) wire 850, a hard stop 870, and a face seal 811. The plunger spring 830 and the FM spring 840 may be, for example, compression springs, and are shown as being in their rest position when the intermediate pump chamber 800 is in this initial position. Figure 8 The initial position of the plunger 820 and the sliding fluid member 815 shown in the example can also be referred to as the parking position at the front 800a of the intermediate pumping chamber 800. Of course, other types of springs or other types of devices can be used instead of the spring in the exemplary intermediate pumping chamber 800.

[0072] The sliding fluid component 815 may be configured with an anchoring portion 815a, a needle / tube connector 815b, and a flow orifice 812. The sliding fluid component 815 may include a flow orifice 812 constructed into the sliding fluid component 815. The sliding fluid component 815 may be coupled to, for example, Figure 1 The needle or cannula 129. The anchoring portion 815a may include structures connected to the needle / cannula coupling 815b (not shown in this example for ease of illustration). These structures are configured to provide a fluid passage in a flow orifice 812 that allows liquid medication to enter the flow orifice and flow in a fluid path 816 leading to the needle / cannula.

[0073] In an exemplary intermediate pumping chamber 800, a passive check valve 810 can be configured to operate when the pumping chamber is filled with water from a reservoir ( Figure 1 To prevent backflow of liquid medication (as shown in the examples below).

[0074] The plunger 820 can be configured to form a leak-proof seal against the side of the abutment chamber body 880. As shown in later examples, the plunger 820 is operable to draw liquid medication from a reservoir and deliver the liquid medication through a fluid path 816 leading to a needle or cannula (not shown in this example). The rear surface 800b of the plunger 820 facing the intermediate pumping chamber 800 can be coupled to or abut against the plunger spring 830. The end of the plunger spring 830 opposite the plunger 820 can be coupled to or abut against the hard stop 870.

[0075] In this example, the plunger 820 is configured with a plunger channel 820a and a plunger hard stop 860. The plunger channel 820a may be a hollow central portion in which the anchoring portion 815a of the sliding fluid member 815 is fitted. The plunger channel 820a may be configured to surround the anchoring portion 815a of the sliding fluid member 815. The interface between the plunger channel 820a and the anchoring portion 815a is leak-proof, but the anchoring portion 815a is configured to slide back and forth through the plunger channel 820a.

[0076] A face seal 811 may be disposed between the plunger 820 and the needle / cannula connection 815b of the sliding fluid member 815 to provide a leak-proof seal. The face seal 811 may be formed as a compression seal between the surfaces of the sliding fluid member 815 and the plunger 820. Alternatively or additionally, the face seal 811 may be an elastomeric seal coupled to the sliding fluid member 815 (or the plunger 820). The face seal 811 may be configured to restrict any leakage of liquid medication through orifice 812 or around orifice 812 into the fluid path 16 leading to the needle or cannula. The face seal 811 may also be configured to prevent liquid medication from flowing to the patient when the intermediate pump chamber is in its initial position. During some phases of operation, the face seal 811 may be under pressure, for example, from the plunger spring 830 of the intermediate pump chamber 800, which prevents any liquid medication from entering the fluid path 816.

[0077] SMA wire 850 can be nitinol or other known shape memory alloy wire, operable to change length or shape in response to the application of current. For example, SMA wire 850 can be circuitically coupled to a power source, responding to a controller (such as...) Figure 1 When actuated by a control signal (as shown), the circuit is configured to apply current or voltage to actuate the SMA wire 850. The hard stop 870 can be configured to restrict the movement of the plunger 830 when the hard stop 870 is contacted by the plunger hard stop 860.

[0078] Figure 9 The intermediate pumping chamber of the delivery pump unit is shown. Figure 8The example shows a side sectional view of the pumping cycle in the intermediate pumping chamber transitioning from its initial state. Figure 9 In the example, the SMA cable 850 can be energized (or actuated) by the controller. In response to being energized or actuated, the SMA cable 850 can begin to pull the anchor portion 815a of the sliding fluid member 815 toward the rear portion 800b of the intermediate pumping chamber 800 (in the direction indicated by arrow G toward the rear portion 800b).

[0079] As the anchor portion 815a is pulled toward the rear 800b, the plunger spring 830 and FM spring 840 are compressed from their rest positions. Additionally, a vacuum is created, which draws liquid drug 825 from the reservoir into the pump chamber 822 via the reservoir connector 801. As the anchor portion 815a is pulled toward the rear 800b by the SMA wire 850, the face seal 811 maintains the pressure applied to the plunger 820, thereby preventing liquid drug from entering the flow orifice 812.

[0080] Figure 10 It shows Figure 9 The intermediate pumping chamber in the example is shown as a side sectional view in its filled state before liquid medication is delivered from the pumping chamber. (See example...) Figure 10 In the example, the controller (not shown in this example) no longer causes current to be applied to the SMA wire 850.

[0081] When current is removed from the SMA wire 850, the force applied by the FM spring 840 can begin to cause a reverse movement of the anchor portion 815a of the sliding fluid member 815. The anchor portion 815a can begin to travel within the plunger 820 and through the plunger channel 820a, while the plunger 820 is temporarily hydraulically stopped in place on the hard stop 860 because the surface area of ​​the plunger is larger than the portion of the surface area of ​​the sliding fluid member opposite the face seal 811 (due to the incompressible volume of the liquid drug 825).

[0082] exist Figure 10 In this example, the SMA wire 850 can be energized by a controller, for example, until the controller detects a current spike when the plunger hard stop 860 strikes the wall formed by the hard stop 870. In this example, the release timing of the plunger 820 can be adjusted by the hydraulic damping generated by the liquid drug 825 in the filled pump chamber 822 and the pull exerted on the anchoring portion 815a by the energized SMA wire 850.

[0083] Since the sliding fluid member 815 does not displace the fluid during its movement toward the front 800a, there may be no additional force preventing the sliding fluid member 815 from reaching the "parking position" before the plunger 820 begins to move toward the front 800a. Under the action of the plunger 820, all liquid drug 825 can be discharged from the pump chamber 822.

[0084] Figure 11 An exemplary intermediate pumping chamber is shown. Figure 4 The example transitions from a filled state to a transport state cross-section view.

[0085] Based on the spring stiffness of FM spring 840, the surface area of ​​the plunger in contact with the fluid, the viscosity of the fluid, the flow orifice parameters 12, and the fluid path parameters 816, etc., in Figure 11 In the example, the plunger 820 can begin to travel toward the parking position of the front portion 800a before the sliding fluid member 815 reaches the parking position abutting the front portion 800a of the intermediate pumping chamber 800. Figure 11 In the diagram, the sliding fluid member 815 is shown in a resting position abutting the front portion 800a of the intermediate pumping chamber 800. A plunger spring 830 applies a force to the plunger 820, causing the plunger 820 to move toward the front portion 800a. As the plunger 820 moves and the flow orifice 812 is no longer sealed by the face seal 811, liquid drug 825 is discharged from the pump chamber 822 through the movement of the plunger 820 toward the front portion 800a of the intermediate pumping chamber 800.

[0086] When the plunger spring 4 returns to the position as shown... Figure 8 When in the initial or parking position shown, the intermediate pumping chamber 800 can be ready and waiting for another pulse.

[0087] Figure 12 An exemplary configuration of electrical contacts for various control aspects of a delivery pump device is shown.

[0088] Exemplary configuration 1200 illustrates examples of plunger flexure 1230, hard stop flexure 1240, and controller 1210.

[0089] The plunger flexure 1230 may include a plunger flexure latching portion 1233. The plunger flexure latching portion 1233 may be a protrusion located at the end of the plunger flexure 1230, such as... Figures 2 to 7 As shown in the foregoing embodiments, the plunger flexure latching portion 1233 may include plunger flexure latching portion (PFS) contacts 1237a and 1237b connected together by wire 121.

[0090] The rigid stop flexure 1240 may include a rigid stop latching portion 1243. Rigid stop latching portion (HSS) contacts 1247a and 1247b are disposed within the rigid stop flexure latching portion 1243. The rigid stop flexure latching portion 1243 may be a recess or a bowl-shaped indentation in the rigid stop flexure 1240, such as... Figures 2 to 7 As shown in the previous embodiment, HSS contacts 1247a and 1247b are shown as being coupled to a drug delivery device (such as...) via a wired connector. Figure 1 The controller 1210 (104 in the example). The plunger flexure latch 1233 is configured to interact with the hard stop latch 1243. Of course, the plunger flexure latch 1233 and the hard stop latch 1243 may have other shapes that allow the corresponding latches 1233 and 1243 to engage.

[0091] Controller 1210 can be coupled to HSS contact 1247a via connector 1203 and to HSS contact 1247b via connector 1207. Controller 1210 can be operable to respond when the plunger flexure latch 1233 moves in the direction of arrow M and PSF contacts 1237a and 1237b contact HSS contacts 1247a and 1247b respectively. Once contact is made, the circuitry in controller 1210 is complete, indicating that the plunger has reached the hard stop in the intermediate pumping chamber (shown in the previous example). In the example of 1200, electrical contacts are shown as an example; however, other devices and mechanisms can be used to determine, for example, electrical contacts. Figure 1 The status of the drug delivery device 105, and other devices and mechanisms such as additional electrical switches and interconnects, optical devices coupled to the controller and configured to indicate plunger position, magnetic / eddy current detectors, capacitive and fluid detection devices coupled to various components in the pump chamber, linear variable displacement sensors (LVDTs) or other linear displacement measuring instruments, pressure sensors, and flow sensors on the inlet or Bourdon tube. For example, the Bourdon tube may be configured to detect pressure that causes strain or deformation in the pipeline (such as fluid path 16 or 816). For example, the flow sensor may be operable in response to check valve leakage or backflow.

[0092] In another example, such as Figure 1 102 or Figure 12 The 1210 controller can be configured to execute logic that causes the controller to perform different functions. Figure 13 It can be utilized Figures 1 to 12 The example is a flowchart of the process of discharging drugs from a delivery pump device.

[0093] In process 1300, for example, the controller can determine the time when the drug is dispensed from the delivery pump device. For example, the controller can be equipped with a clock or input device that instructs the controller to deliver a certain dose of drug to the user (1310).

[0094] In response to this determination, the controller may generate a control signal to actuate the delivery pump (1320). The controller may be operable to output the control signal, for example, to a pump mechanism operable to move a sliding fluid component (as referenced). Figures 2 to 11 (as illustrated in the example).

[0095] In this example, the controller may be operable to apply control signals to the pump mechanism (1330). The pump mechanism may be a shape memory alloy wire (as described with reference to the previous examples) or an electric motor. In some examples, the intermediate pumping chamber and associated mechanism may include a drive system coupled to the sliding fluid component (in... Figures 2 to 11 (As shown in the example). The drive system can be configured to move via, for example, a rotary cam, linkage, rack and pinion, or lead screw with an escapement. In another specific example, the drive system can be geared to allow the use of a low-power electric motor.

[0096] When a control signal is applied to the pump mechanism, the pump chamber (as shown in the previous example) is filled with liquid medication. As described with reference to the previous example, shape memory alloy wire is used to pull the sliding fluid component to enable the filling of the pump chamber.

[0097] The controller can, for example, be configured to determine the removal of a control signal (1340) from the pump mechanism of the delivery pump unit. See reference [reference needed]. Figure 12 The determination is performed as described in the exemplary configuration shown. As an alternative example, the sliding fluid member can be magnetically excited, and eddies can be measured and evaluated to determine the proximity of the sliding fluid member to the wall of the rigid stop. The eddy configuration allows for partial or multiple doses within the same intermediate pumping chamber because the eddies can have different values ​​as the sliding fluid member travels. Of course, other methods or electrical contact arrangements can be used to determine the position of the sliding fluid member within the intermediate pumping chamber. At 1350, when it is determined that the control signal can be removed from the pump mechanism, the controller can stop applying a signal to the drive mechanism (such as a shape memory alloy) or has already applied a signal (in response to the control signal). By stopping the application of the control signal, the controller enables the spring in the intermediate pumping chamber to begin discharging the liquid medication from the pump chamber and discharging the liquid medication to the patient via a fluid path leading to the needle / cannulas. For example, the discharging of the liquid medication can enable the delivery of liquid medication from a drug delivery device.

[0098] In an operational example, delivering liquid medication to a needle or cannula in response to the removal of a control signal from the pump mechanism may include additional steps. For instance, in response to the shape memory alloy ceasing to pull the sliding fluid member, the fluid member spring may begin to decompress. The decompressed fluid member spring can cause the sliding fluid member to move towards the front of the chamber body, while the plunger remains stationary due to hydraulic resistance from the liquid medication within the pump chamber. The liquid medication is incompressible, which counteracts the force exerted by the plunger spring until the sliding fluid member reaches... Figure 2 The example is shown up to the rest position or initial position. In this example, the flow orifice allows liquid medication to flow into the needle coupling when the sliding fluid member reaches the initial position. When the sliding fluid member is in the initial or rest position, the plunger spring begins to decompress, causing liquid medication to be discharged from the pump chamber into the needle coupling.

[0099] At 1360, the controller may be operable to confirm that the liquid drug is being delivered or discharged from the pumping chamber or that delivery or discharge from the pumping chamber has begun. For example, the sliding fluid component may include electrical contacts, such as in the previous eddy current example.

[0100] The entire system can be moved by sealing the back of the plunger / sliding fluid component and using a small air pump to create a vacuum. This system allows for the measurement of pressure within the vacuum chamber, and the plunger's position can be determined using Boyle's law (P1V1 = P2V2).

[0101] As described in U.S. Patent US10,391,237, the system can be modified to use phase change wax instead of shape memory alloy in the movement of the plunger, the disclosure of which is incorporated herein by reference in its entirety.

[0102] Software-related implementations of the technologies described herein may include, but are not limited to, firmware, special-purpose software, or any other type of computer-readable instructions executable by one or more processors. Hardware-related implementations of the technologies described herein may include, but are not limited to, integrated circuits (ICs), application-specific integrated circuits (ASICs), field-programmable arrays (FPGAs), and / or programmable logic devices (PLDs). In some examples, the technologies described herein and / or any systems or components described herein may be implemented using a processor that executes computer-readable instructions stored on one or more memory components.

[0103] Additionally or alternatively, while examples can be described with reference to closed-loop algorithm implementations, variations of the disclosed examples can be implemented to achieve open-loop use. Open-loop implementations allow for the use of different insulin delivery methods, such as smart pens or syringes. For example, the disclosed AP application and algorithm can be operable to perform various functions related to open-loop operation, such as generating prompts requesting input of information such as weight or age. Similarly, insulin doses can be received by a user via a user interface through the AP application or algorithm. Other open-loop actions can also be implemented by adjusting user settings in the AP application or algorithm.

[0104] Some examples of the disclosed apparatus may be implemented, for example, using a storage medium, a computer-readable medium, or an article of manufacture capable of storing instructions or instruction sets, which, if implemented by a machine (i.e., a processor or microcontroller), can cause the machine to perform the methods and / or operations of the examples according to this disclosure. Such a machine may include, for example, any suitable processing platform, computing platform, computing device, processing device, computing system, processing system, computer, or processor, and may be implemented using any suitable combination of hardware and / or software. Computer-readable media or articles of manufacture may include, for example, any suitable type of storage unit, memory, storage article, storage medium, storage device, storage article, storage medium, and / or storage unit, such as memory (including non-transitory memory), removable or non-removable media, erasable or non-erasable media, writable or rewritable media, digital or analog media, hard disk, floppy disk, read-only optical disc storage (CD-ROM), recordable optical disc (CD-R), rewritable optical disc (CD-RW), optical disc, magnetic media, magneto-optical media, removable memory cards or discs, various types of digital multifunction discs (DVDs), magnetic tape, or cassette tape, etc. Instructions may include any suitable type of code implemented using any appropriate high-level, low-level, object-oriented, visual, compiled, and / or interpreted programming language, such as source code, compiled code, interpreted code, executable code, static code, dynamic code, cryptographic code, and programming code. Programming code contained on a non-transitory computer-readable medium can enable a processor to perform functions, such as those described herein, when executing the programming code.

[0105] Certain examples of this disclosure have been described above. However, it is explicitly stated that this disclosure is not limited to those examples, but rather, it is intended that additions and modifications to the content explicitly described herein be included within the scope of the disclosed examples. Furthermore, it should be understood that the features of the various examples described herein are not mutually exclusive and can exist in various combinations and arrangements without departing from the spirit and scope of the examples of this disclosure, even if such combinations or arrangements are not explicitly expressed herein. Indeed, variations, modifications, and other implementations of the content described herein will occur to those skilled in the art without departing from the spirit and scope of the disclosed examples. Therefore, the disclosed examples should not be limited solely to the foregoing illustrative description.

[0106] The program aspect of this technology can be considered as a "product" or "article of manufacture" generally carried or embodied in executable code and / or associated data on a non-transitory, machine-readable medium. Storage-type media include any or all tangible memory, or associated modules thereof, such as various semiconductor memories, tape drives, and disk drives, which can provide non-transitory storage for software programming at any time. It is important to emphasize that this abstract of the disclosure is provided to enable the reader to quickly determine the nature of the technology disclosed. It should be understood at the time of submission that it is not intended to interpret or limit the scope or meaning of the claims. Furthermore, in the foregoing detailed description, various features are grouped together in a single example to simplify the disclosure. The approach of this disclosure should not be construed as reflecting an intention to require more features than are expressly recited in each claim. Rather, as reflected in the appended claims, the subject matter of the invention lies in all features less than those in a single disclosed example. Therefore, the following claims are hereby incorporated into the detailed description, wherein each claim is itself a separate example. In the appended claims, the terms "comprising" and "in which" are used as simple English equivalents of the respective terms "including" and "wherein". Furthermore, terms such as “first,” “second,” and “third” are used merely as identifiers and are not intended to impose an order requirement on their objects.

[0107] The foregoing description, which provides examples, is for illustrative and descriptive purposes. It is not intended to be exhaustive or to limit this disclosure to the precise forms disclosed. Many modifications and variations are possible with respect to this disclosure. The scope of this disclosure is intended to be limited not by the specific embodiments, but by the appended claims. Future applications claiming priority to this application may claim the disclosed subject matter in different ways and may generally include any group of one or more limitations as shown in the various disclosures herein or otherwise.

Claims

1. A wearable drug delivery device, the wearable drug delivery device comprising: A reservoir configured to store liquid medicine; and A delivery pump assembly, connected to the reservoir for receiving the liquid drug from the reservoir, the delivery pump assembly comprising: The main body of the chamber defines the pump chamber. An inlet port configured to allow liquid medication to be drawn from the reservoir into the pump chamber. A sliding fluid component, the sliding fluid component including a flow orifice and a fluid path to a needle, A plunger, the plunger including a plunger channel configured to engage with the sliding fluid member, and A shape memory alloy wire, the shape memory alloy wire being connected to the sliding fluid component. in: The shape memory alloy wire is operable to draw the liquid drug from the reservoir through the inlet port into the pump chamber by pulling the sliding fluid member and the plunger along a first direction, and The sliding fluid component is configured such that the liquid drug can be drawn into the pump chamber and discharged from the pump chamber into a fluid path leading to the needle for output.

2. The wearable drug delivery device according to claim 1, wherein the sliding fluid component further comprises: A face seal is configured to maintain a leak-proof seal against the first plunger surface of the plunger when the shape memory alloy wire pulls the anchor portion.

3. The wearable drug delivery device according to claim 1, wherein the sliding fluid component further comprises: An anchoring portion, the anchoring portion being coupled to the shape memory alloy wire, wherein the anchoring portion is configured to engage the plunger by extending transversely into a plunger channel of the plunger in response to a pull of the shape memory alloy wire; and A pin connector, which is connected to the anchoring portion.

4. The wearable drug delivery device of claim 1, wherein the plunger is configured to directly physically contact the inner surface of the chamber body to define the pump chamber.

5. The wearable drug delivery device according to claim 1, further comprising: A fluid component spring having a first end connected to an anchoring portion; and A plunger spring having a first end connected to the plunger. The fluid component spring and the plunger spring are configured to be pulled from a rest position to a compressed position by the shape memory alloy wire.

6. The wearable drug delivery device according to claim 1, further comprising: A rigid stop, which is opposite to the inlet port; A fluid component spring having a first end connected to an anchoring portion; as well as A plunger spring having a first end connected to the plunger. The hard stop is configured to contact the second end of the plunger spring, which is opposite to the first end of the plunger spring, and the hard stop is also configured to contact the second end of the fluid component spring, which is opposite to the first end of the fluid component spring that is connected to the plunger.

7. The wearable drug delivery device according to claim 6, wherein: The rigid stop also includes a rigid stop flexible latching part; and The plunger also includes a plunger flexure latching part. The plunger flexure latch and the rigid stop flexure latch are configured to engage with each other when the shape memory alloy wire pulls the anchoring portion.

8. The wearable drug delivery device according to claim 1, wherein the inlet port further includes a passive check valve.

9. The wearable drug delivery device according to claim 1, further comprising: A power source coupled to the shape memory alloy wire, wherein power from the power source is applied to the shape memory alloy wire to cause the shape memory alloy wire to contract and thereby pull the anchor portion.

10. The wearable drug delivery device of claim 6, further comprising a controller communicatively coupled to a power source, wherein the controller is operable to: The power supply is activated in response to an automated insulin delivery application setting, so that power is applied to the shape memory alloy wire.

11. A delivery pump device for a wearable drug delivery device, the delivery pump device comprising: A chamber body defining a pump chamber, the chamber body including a rigid stop and an inlet valve operable to receive liquid medication from a reservoir; A plunger that is movable within the pump chamber of the chamber body and is provided with a plunger passage; A sliding fluid component, movable within the pump chamber, includes a needle coupling, a flow orifice, a face seal, and an anchoring portion, wherein the anchoring portion is positioned in a leak-proof configuration within the plunger channel and is movable within the plunger channel; and A shape memory alloy wire connected to the anchoring portion, wherein the shape memory alloy wire is operable to pull the anchoring portion and the plunger toward the hard stop.

12. The delivery pump device of claim 11, wherein the face seal is configured to maintain a leak-proof seal against the first surface of the plunger to form the leak-proof configuration.

13. The delivery pump device according to claim 11, wherein the plunger further comprises: A plunger hard stop, the plunger hard stop being configured as a hard stop engaging the housing; and A plunger spring, wherein the plunger spring is in a compressed position when the plunger hard stop engages the hard stop of the chamber body.

14. The delivery pump device of claim 11, wherein the shape memory alloy wire is configured as follows: In response to the application of an electric current to the shape memory alloy wire, the sliding fluid member and the plunger are pulled away from the front of the chamber body along a first direction, wherein, The liquid drug is drawn from the reservoir into the pump chamber through the inlet valve; The sliding fluid member and the plunger are stopped in response to the cessation of the application of current to the shape memory alloy wire, wherein the pump chamber is filled with the liquid drug.

15. The delivery pump device according to claim 14, further comprising: plunger spring; and Fluid component spring, in: The plunger spring is configured to contact a hard stop in the chamber body. The fluid component spring is configured to contact the hard stop of the chamber body, and When the shape memory alloy wire stops pulling the sliding fluid component, the plunger spring and the fluid component spring are compressed.

16. The delivery pump device according to claim 15, wherein the delivery pump device is further configured to: In response to the shape memory alloy ceasing to pull the sliding fluid member, the fluid member spring begins to decompress, causing the sliding fluid member to move toward the front of the chamber body, while the plunger remains stationary due to the hydraulic resistance of the liquid drug in the pump chamber.

17. The delivery pump device according to claim 16, wherein the delivery pump device is further configured to: When the sliding fluid component reaches its initial position, the flow orifice allows the liquid drug to flow into the needle connector; and The plunger spring begins to decompress, causing the liquid drug to be discharged from the pump chamber into the needle connector.

18. The delivery pump device according to claim 11, further comprising: A first fluid path component connects the reservoir to the inlet port of the housing; A second fluid path component connects the outlet port of the housing to the cannula, wherein an inlet valve is positioned within the inlet port and an outlet valve is positioned within the outlet port.

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