Medicament fluid delivery device

Abstract

Drug fluid delivery devices and methods are provided in which the delivery device has a dispensing unit and a drive unit that are attachable together. The dispensing unit includes a dispenser for delivering drug fluid to a user and a reservoir configured to be filled with a variable amount of drug fluid received from a drug fluid syringe. The drive unit includes a control unit that controls the drive unit and causes the drug fluid in the reservoir to be pumped through the dispenser and a registration mechanism configured to work with the dispensing unit to determine a state of the reservoir, including an initial fluid level of the filled reservoir.

Description

[0001] Cross-references to related applications

[0002] This application claims priority to U.S. Provisional Patent Application No. 63 / 110,258, filed November 5, 2020, which is incorporated herein by reference. Technical Field

[0003] This disclosure relates to systems and methods for delivering drug fluids to humans or animals to treat or prevent disease. Background Technology

[0004] Drug fluids used to treat or prevent diseases in humans or animals typically need to be administered at regular intervals. Many different devices are known for drug fluid administration, including syringes, intravenous drips, and cannulas. Regular administration of drug fluids outside of a medical setting presents numerous challenges in ensuring safe and appropriate dosing.

[0005] One form of medication fluid that needs to be administered outside of a medical setting is insulin administration. Millions of people with insulin-dependent diabetes worldwide rely on multiple daily injections (MDI) to control their diabetes. Insulin pens are the most common method of insulin delivery globally. Currently, most insulin is delivered via standard insulin pens rather than by humans using alternative delivery methods such as smart insulin pens, insulin pumps, or automated insulin delivery systems.

[0006] People who use insulin pens often find it difficult to keep their blood sugar within the desired range throughout the night and may have to wake up multiple times each night to administer insulin, otherwise they risk both high and low blood sugar. The result is disrupted sleep and other problems, such as fatigue, anxiety, and grogginess upon waking in the short term, and more serious health risks in the long term.

[0007] Automated insulin delivery (AID) systems, such as insulin pumps with feedback from a continuous glucose monitor (CGM), can continuously control blood glucose levels, including throughout the night. These systems are expensive, can be highly invasive, and may require frequent infusion kit replacements. Many insulin pen users choose to use insulin pumps or are unable to use them and rely solely on insulin pens. Switching between daytime insulin pen use and overnight insulin pump use has not been proven feasible. Therefore, people with diabetes may have no practical choice but to manually adjust their insulin levels with their insulin pen when they wake up at night.

[0008] The foregoing discussion of the background of this invention is intended only to facilitate understanding of the invention. It should be understood that this discussion is not an admission or endorsement that any material mentioned is part of common general knowledge in the art as of the priority date of this application. Summary of the Invention

[0009] According to one aspect of the present technology, a drug fluid delivery device is provided, the drug fluid delivery device comprising:

[0010] The dispensing unit has a dispenser for delivering drug fluid to a user and a reservoir configured to be filled with a variable amount of drug fluid received from a drug fluid injector; and

[0011] A drive unit, which can be attached to a dispensing unit, includes a control unit that controls the drive unit and pumps the drug fluid in the reservoir through the dispenser.

[0012] The drive unit includes a registration mechanism configured to work together with the dispensing unit to determine the state of the reservoir, including the initial level of the drug fluid in the reservoir.

[0013] The dispensing unit may include a plunger movable relative to a reservoir to apply pressure to the drug fluid in the reservoir to pump the drug fluid through the dispenser, and the drive unit includes a plunger actuating member configured to engage with the plunger and be driven by a drive mechanism.

[0014] The registration mechanism may include sensors regarding the state of the reservoir, wherein the state of the reservoir also includes one or more of the following: the reservoir is present, the reservoir is engaged but not ready, and the current liquid level of the filled reservoir.

[0015] The registration mechanism can be combined with the plunger operating member to detect the plunger's position and determine the reservoir's state based on that position. The registration mechanism can determine the initial filling state of the reservoir by moving the plunger operating member in the opposite direction to the direction of drug fluid dispensing. The registration mechanism can detect when the dispensing unit is attached to the drive unit. The registration mechanism can be used by the control unit to determine the volume of drug fluid in the reservoir based on the position of the plunger operating member.

[0016] The registration mechanism can determine the original position of the plunger operating component as a reference for the empty state of the reservoir and determine the initial registration position of the plunger operating component as a reference for the filled state of the reservoir.

[0017] The drive mechanism may include a stepper motor for controlling and measuring the linear movement of the plunger operating member, and the control unit may control the delivery amount of drug fluid by actuating the stepper motor in steps.

[0018] The plunger actuation member can be configured as a sensor that actuates the separation state when the dispensing unit is separated from the drive unit, and as a sensor that actuates the operation state when the plunger actuation member engages with the plunger to prepare for delivery of drug fluid.

[0019] The plunger operating member can be configured to have a first orientation that depends on and indicates when the drive unit disengages from the dispensing unit, and a second orientation that engages with the plunger and indicates an operating state. The plunger operating member can be configured to have a third orientation that is caused by the engagement of the dispensing unit with the drive unit and indicates a standby state ready for registration to induce the second orientation.

[0020] The control unit can be configured to automatically activate the plunger operating member by moving a predetermined activation distance in the plunger delivery direction to under-activate the drug fluid, such that no drug fluid is delivered during the activation phase. The control unit can determine that the dispensing unit is attached to the drive unit and can control the plunger operating member to automatically activate the plunger operating member and find its initial position. The control unit can be configured to reset the plunger operating member by moving it back to its original position in the plunger delivery direction when the control unit receives an instruction that the drive unit is connected to the charger unit.

[0021] The drive unit may include electrical contacts that are connected to complementary electrical contacts of a recharging base station to allow the power supply to be recharged by the base station when the drive unit is disconnected from the distribution unit.

[0022] The control unit may include a wireless communication module for communicating with a remote device for receiving information used by the drug delivery algorithm of the control unit to control the delivery of drug fluid from the dispensing unit.

[0023] The drive mechanism may include a stall detector to detect motor stall caused by blockage in fluid delivery or sudden stop of plunger movement.

[0024] The control unit can be configured to initialize the plunger operating member by sensing that the dispensing unit is attached to the drive unit and controlling the drive mechanism to move in a first direction opposite to the plunger delivery direction until the plunger operating member engages with the end of the plunger.

[0025] The control unit can be configured to generate status indications or warnings and transmit these indications or warnings to the user device and / or to have the indications or warnings displayed or indicated by the drive unit itself.

[0026] The reservoir can be configured to be filled from an autoinjector for the automatic dispensing of a pre-selected amount of drug fluid.

[0027] The drug fluid delivery device may include a connector configured to releasably attach a dispensing unit to a drug fluid syringe, wherein the connector includes a first engagement configured to engage with the syringe and a second engagement configured to engage with the dispensing unit, wherein the second engagement includes a sealing arrangement configured to block a fluid path to the dispensing unit during filling of the reservoir.

[0028] The reservoir may include an inlet port configured to receive drug fluid from a drug fluid injector and a second port configured to engage with a sealing arrangement. One of the first or second engagements may have a stronger attachment arrangement than the other for staged disconnection of the connector after filling. The connector provides a fluid passage between the drug fluid injector and the reservoir, and can be discarded once the reservoir has been filled with the drug fluid injector.

[0029] The dispensing unit may include a housing containing a reservoir and a flat adhesive sheet disposed on one side of the housing, wherein the dispenser may be one or more needles or microneedles extending from the adhesive surface of the adhesive sheet opposite to the housing, and wherein the flat adhesive sheet includes removal tabs to aid removal from the user's skin.

[0030] The drive unit and the dispensing unit can be releasably attached using a latching arrangement configured to disengage in one direction when the user holds the removal tab. The drive unit can be releasably attached to the dispensing unit by means of complementary configurations on the drive unit and the dispensing unit.

[0031] The dispensing unit may include a housing with an upright portion in which a reservoir and a plunger are housed. The housing includes rigid ribs for corresponding clearance engagement with a drive unit for precise positioning and movement of the plunger.

[0032] According to another aspect of the present technology, a method is provided, the method comprising:

[0033] The drug fluid syringe is releasably attached to the dispensing unit, which has a dispenser for delivering drug fluid to the user and a reservoir for containing the drug fluid.

[0034] The actuated drug fluid injector is used to fill the reservoir with a variable amount of drug fluid from the drug fluid injector.

[0035] Separate the drug fluid injector from the dispensing unit.

[0036] A drive unit is attached to a dispensing unit, the drive unit including a control unit that controls the drive unit and pumps the drug fluid in the reservoir through the dispenser; and

[0037] The drive unit is registered with the dispensing unit to determine the state of the reservoir, including the initial level of the drug fluid in the reservoir.

[0038] The method may include applying a dispensing unit to a user, such that the dispenser engages with the user to deliver drug fluid to the user.

[0039] The step of attaching a drug fluid injector to a dispensing unit may include attaching the drug fluid injector to a connector by means of a first engagement that connects to the needle attachment point of the drug fluid injector. The connector may be configured to be pre-attached to the dispensing unit by means of a second engagement, wherein the dispensing unit and the connector are disposed in a sterile package opened by the user.

[0040] The step of separating the drug fluid injector from the dispensing unit may include: separating one of the first and second joints of the connector from the respective injector and dispensing unit; separating the other of the first and second joints of the connector in a phased disconnect manner; and discarding the connector.

[0041] The method may include: continuous use of the delivery device by continuous application over a period of time; intermittent use of the delivery device by application over a period of time and non-application over a period of time; or periodic use of the delivery device by continuous and / or intermittent use over multiple wear periods.

[0042] According to another aspect of the present technology, a computer-implemented method for controlling the delivery of drug fluid to a user is provided, the method being executed at a control unit of a drug fluid delivery device, wherein the drug fluid delivery device includes a dispensing unit and a drive unit, the dispensing unit having a dispenser for delivering drug fluid to a user and a reservoir configured to be filled with a variable amount of drug fluid received from a syringe, the drive unit being associated with the dispensing unit and the drive unit causing the drug fluid in the reservoir to be pumped through the dispenser, the method comprising: determining the state of the reservoir by registering the drive unit with the dispensing unit, wherein the state of the reservoir includes an initial level of drug fluid in the reservoir.

[0043] The method may include receiving input from a registration unit to indicate different states of the reservoir. The method may include controlling a drive unit to deliver a predetermined amount of drug fluid based on monitoring of user needs and a drug delivery algorithm. The method may include initializing the drug delivery algorithm to assume a baseline level of drug fluid for the patient and decreasing the assumed amount over time.

[0044] The method may include: sensing attachment of the dispensing unit to the drive unit; and determining the amount in the reservoir based on the position of a component of the drive unit relative to the reservoir. The method may also include: sensing attachment of the dispensing unit to the drive unit; and automatically activating the drive unit. Furthermore, the method may include: sensing detachment of the dispensing unit from the drive unit and connection of the drive unit to the charger unit; and resetting the drive unit to its original position.

[0045] The method may include receiving wireless communication from a remote device, including information used by a drug delivery algorithm of a control unit, to control the delivery of drug fluid from a dispensing unit. The information received from the remote device may include the type of drug that influences the drug delivery behavior.

[0046] The method may include transmitting information about drug delivery to a remote device for storage and display by the remote device. The information transmitted to the remote device may include one or more of the following: dosing records, reservoir volume, and battery charge level.

[0047] According to another aspect of the present technology, a drug fluid delivery device is provided, the drug fluid delivery device comprising:

[0048] The dispensing unit has a dispenser for delivering drug fluid to a user and a reservoir for containing drug fluid received from a drug fluid injector.

[0049] A drive unit, associated with a dispensing unit, pumps the drug fluid in the reservoir through a dispenser; and

[0050] A connector for engaging a drug fluid injector to a dispensing unit during filling of a reservoir, the connector including a sealing arrangement configured to block a fluid path to the dispenser.

[0051] According to another aspect of the present technology, a drug fluid delivery device is provided, the drug fluid delivery device comprising:

[0052] The dispensing unit has a dispenser for delivering drug fluid to a user and a reservoir for receiving drug fluid received from a drug fluid syringe, wherein the drug fluid is pumped from the reservoir through the dispenser by means of a plunger acting on the reservoir; and

[0053] A drive unit, associated with a dispensing unit, includes a plunger actuating member that applies force to a plunger during drug fluid delivery, wherein the plunger actuating member is configured to move against the delivery direction of the plunger to position an end of the plunger at an initial position.

[0054] According to another aspect of the present technology, a drug fluid delivery device is provided, the drug fluid delivery device comprising:

[0055] The dispensing unit has a dispenser for delivering drug fluid to a user and a reservoir for receiving drug fluid received from a drug fluid syringe, wherein the drug fluid is pumped from the reservoir through the dispenser by means of a plunger acting on the reservoir; and

[0056] A drive unit, associated with a dispensing unit, includes a plunger actuating member that applies force to a plunger during drug fluid delivery, wherein the plunger actuating member is configured to return to its original position in the delivery direction of the plunger only when the drive unit is disconnected from the dispensing unit and attached to a charger unit.

[0057] According to another aspect of the present technology, a drug fluid delivery device is provided, the drug fluid delivery device comprising:

[0058] The dispensing unit has a dispenser for delivering drug fluid to a user and a reservoir for receiving drug fluid received from a drug fluid syringe, wherein the drug fluid is pumped from the reservoir through the dispenser by means of a plunger acting on the reservoir; and

[0059] A drive unit, associated with a dispensing unit, includes a plunger actuating member that applies force to the plunger during drug fluid delivery, wherein the control unit is configured to automatically actuate the plunger actuating member by moving the plunger actuating member a predetermined actuation distance in the plunger delivery direction to under-start the drug fluid, such that no drug fluid is delivered during the actuation phase.

[0060] According to another aspect of the present technology, a computer-implemented method for controlling the delivery of a drug fluid to a user is provided. The method is executed at a control unit of a drug fluid delivery device, wherein the drug fluid delivery device includes a dispensing unit and a driving unit. The dispensing unit has a dispenser for delivering drug fluid to the user and a reservoir for receiving drug fluid received from a drug fluid injector. The driving unit is associated with the dispensing unit and pumps the drug fluid in the reservoir through the dispenser. The method includes:

[0061] The control drive unit delivers a certain amount of drug fluid according to the drug delivery algorithm, wherein the drug delivery algorithm is initialized to assume that the patient has a basic level of drug fluid and the assumed amount is reduced over time.

[0062] According to another aspect of the present technology, an insulin delivery device is provided, the insulin delivery device comprising:

[0063] A dispensing unit, releasably attachable to an insulin pen, having at least one needle for delivering insulin to a user and a reservoir for containing insulin received from the insulin pen; and

[0064] A drive unit, associated with a dispensing unit, is used to pump insulin from a reservoir through at least one needle.

[0065] The dispensing unit can be releasably attached to an insulin pen by means of a pen connector. The pen connector may include a first engagement portion connected to the needle attachment point of the insulin pen and a second engagement portion connected to the dispensing unit.

[0066] According to another aspect of the present technology, a method for delivering insulin to a user is provided, the method comprising:

[0067] The insulin pen is releasably attached to a dispensing unit, which has at least one needle for delivering insulin to the user and a reservoir for holding the insulin.

[0068] The insulin pen is activated to fill the reservoir with insulin from the insulin pen.

[0069] The dispensing unit is applied to the user, causing at least one needle to pierce the user's skin;

[0070] Separate the insulin pen from the dispensing unit, and

[0071] The drive unit is attached to the dispensing unit, which pumps insulin from the reservoir through at least one needle to deliver insulin to the user.

[0072] Embodiments of the invention will now be described by way of example only with reference to the accompanying drawings. Attached Figure Description

[0073] In the attached diagram:

[0074] Figures 1A to 1E These are a series of perspective views illustrating the fabrication of an example embodiment of a fluid drug delivery device;

[0075] Figure 2A and Figure 2B This is a perspective view of an example embodiment of a fluid drug delivery device including a dispensing unit and a driving unit;

[0076] Figures 3A to 3D This is a plan view and cross-section of the dispensing unit of an example embodiment of a fluid drug delivery device;

[0077] Figure 4A and Figure 4BThis is a perspective view of an encapsulated dispensing unit of an example embodiment of a fluid drug delivery device;

[0078] Figures 5A to 5C This is a perspective view of the connector of an example embodiment of a fluid drug delivery device;

[0079] Figures 6A to 6D This is a perspective view of the drive unit of an example embodiment of a fluid drug delivery device;

[0080] Figures 7A to 7E These are perspective views of the drive unit of an example embodiment of a fluid drug delivery device, illustrating a series of steps in the control unit;

[0081] Figure 8 This is a block diagram illustrating the drive unit of an example embodiment of a fluid drug delivery device;

[0082] Figure 9 This is a flowchart illustrating a method at the control unit of a drive unit in an example embodiment of a fluid drug delivery device;

[0083] Figures 10A to 10F A series of steps for filling and assembling an example embodiment of a fluid drug delivery device are shown; and

[0084] Figure 11 This is a flowchart illustrating a series of steps for delivering a drug fluid using a fluid drug delivery device. Detailed Implementation

[0085] This disclosure provides apparatus, systems, and methods for delivering drug fluids to a human or animal body. In embodiments of this disclosure, the drug fluid being administered is insulin, and an insulin delivery device is provided; however, the defined apparatus, systems, and methods are applicable to other forms of drug fluids that require periodic administration.

[0086] The drug fluid delivery device comprises two main components: a dispensing unit, including a refillable reservoir for the drug fluid and a dispenser for transdermal or subcutaneous delivery of the fluid; and a drive unit, including a control unit for controlling the drive mechanism to deliver the drug fluid from the reservoir through the dispenser. In some embodiments, the dispensing unit can be releasably attached to the drive unit in a manner that allows interaction between the two main components to control the delivery of the drug fluid from the reservoir through the dispenser. The drive unit may be a durable, reusable component, and the dispensing unit may be a disposable component. The combined dispensing unit and drive unit can be attached to a user's body to deliver a dose of drug fluid over a period of time, such as overnight, without user intervention. The dispenser of the dispensing unit may be at least one transdermal or subcutaneous drug delivery element, such as a needle or microneedle, for delivering the drug fluid to a subject who requires it.

[0087] Some of the aspects and features described herein can be applied to single-item delivery devices in which the dispensing unit and the driving unit are integrated, for example, as a single-use delivery device.

[0088] The drive unit includes a registration mechanism configured to work with the dispensing unit to determine the state of the reservoir. The registration mechanism determines the interaction between the drive unit and the dispensing unit to determine the state of the reservoir and provide a state indication to the control unit. The term "registration mechanism" is used as the "registerer" of the drive unit registered with the dispensing unit. The state of the reservoir can include determining when the drive unit and the dispensing unit engage. The state of the reservoir can be when the reservoir is first engaged in the drive unit before the plunger is positioned. The state of the reservoir can be the initial level of the filled reservoir. The initial level of the reservoir can depend on the variable fill volume of the reservoir and can be related to the "original" or reset position. This initial level can be after adjustments have been made during the start-up phase. The state of the reservoir can also be extended to include the level of the reservoir during the dispensing process.

[0089] The registration mechanism, used by the control unit, determines the volume of drug fluid in the reservoir and the amount of drug fluid delivered from the reservoir. The registration mechanism can be configured to register the position of the plunger engaging with the reservoir in relation to the reservoir's volume level, thereby enabling the drive unit to interact precisely with the dispensing unit. The drive unit includes a control unit that works together with the registration mechanism to receive input regarding the reservoir's state and actuate the drive mechanism. The drive mechanism can be used to determine the plunger's position in relation to the reservoir's volume level. The drive mechanism and registration mechanism can be integrated using a plunger actuating member that abuts against the reservoir plunger to determine the plunger's position and measure its movement. The control unit can include an activation phase and a reset phase depending on the corresponding control of the plunger actuating member.

[0090] The refillable reservoir of the dispensing unit has an inlet port for connection to a drug fluid injector, allowing a user to input a selected, variable amount of drug fluid into the reservoir. The drug fluid injector can be a monitored source, allowing control over the amount of drug fluid administered from the drug fluid delivery device and other devices. The connector may include a disposable connector that provides a fluid path between the injector and the inlet port. The injector may be an auto-injector for automatically dispensing pre-selected amounts of drug fluid, such as an insulin pen.

[0091] The volume of the reservoir is determined through the following process: locating the plunger position, calculating the distance to move to the located plunger position, and converting that distance into the reservoir's volume level. This distance can be calculated using the number of steps in a stepper motor and then converted into a volume level. The conversion from distance to volume can vary along the reservoir, for example, due to draft angles that contribute to the molding process. Therefore, an equation or lookup table is used to determine the conversion from step count to volume, which depends on the position along the reservoir.

[0092] In an example implementation, the drug fluid is insulin, and the drug fluid injector is a portable auto-injector device, such as an insulin pen, allowing the drug fluid delivery device to be filled from the insulin pen, thereby enabling monitoring of the total insulin administered, since the total insulin comes from the same source, namely the insulin pen. The drug fluid delivery device can be an automated insulin delivery (AID) device designed for overnight insulin delivery to diabetic patients using insulin pens. The delivery device can be a precision insulin pump configured as a wearable pad. The delivery device includes a control unit that incorporates a dosing algorithm and receives glucose readings from a continuous glucose monitor or user device and determines when insulin should be delivered.

[0093] Exemplary drug fluid delivery devices, systems, and methods will now be described in a non-limiting manner with reference to the accompanying drawings. The embodiments shown in the figures are particularly applicable to cases where insulin is the drug fluid.

[0094] Figures 1A to 1E The illustration shows a series of steps for filling and preparing components of an example embodiment of a drug fluid delivery device (10), referred to as a "delivery device". An example of a delivery device is an insulin delivery device in the form of an automated insulin delivery (AID) device.

[0095] The delivery device (10) has two main components: a dispensing unit (20) and a drive unit (24). The drive unit (24) is a reusable, durable component used in conjunction with multiple consumable dispensing units (20). The drive unit (24) can be used with hundreds of disposable dispensing units (20). Figure 1A As shown, the dispensing unit (20) may be provided with a connector (22). The dispensing unit (20) may also be provided with a protective tray (19) to protect the dispenser located on the lower side of the dispensing unit (20) during the filling process.

[0096] like Figure 1B As shown, the drug fluid injector (12) can be attached to the connector (22) by engaging the tip of the injector (12) with the connector (22). Alternatively, the injector (12) can be directly engaged with the dispensing unit (20) without the need for the connector (22). The injector (12) can be a standard insulin pen, and the injector (12) can have an injection button (14) with an associated dose selector (not shown), a syringe reservoir, and a needle attachment point. The dispensing unit (20) can receive a variable amount of drug fluid from the injector (12) according to the user's request. This request may include, for example, the duration for which the delivery device is intended to be used or the dose required by the user.

[0097] like Figure 1C As shown, the drive unit (24) is attached to the filled dispensing unit (20) to form a delivery device (10) still disposed in the protective tray (19), as Figure 1D As shown. The delivery device (10) is removed from the protective tray (19) and... Figure 1E It adheres to the user's skin in the form shown. In some embodiments, the dispensing unit (20) may fill in situ on the user's skin before attaching the drive unit (24).

[0098] The dispensing unit (20) is capable of receiving drug fluid from the syringe (12) and delivering such drug fluid to the user percutaneously or subcutaneously at night, for example, when the user is asleep. The drive unit (24) can pump the drug fluid contained in the dispensing unit (20) through a dispenser extending from the dispensing unit (20).

[0099] Figure 2A The implementation of the distribution unit (20) and the drive unit (24) when the distribution unit (20) and the drive unit (24) are attached together is shown in more detail in a perspective view. Figure 2B Another view of the dispensing unit (20) is shown. The dispensing unit (20) can be a low-cost, single-use sterile component that can be filled with drug fluid and can be discarded after use in the delivery device (10).

[0100] The dispensing unit (20) includes a housing (26) housing a reservoir (30) for receiving drug fluid received from the syringe (12) until the drug fluid passes through a dispenser (28) in the form of, for example, at least one needle or microneedle. Figure 3D (As shown in the image) is delivered. The reservoir (30) may be made of a translucent material to allow the user to verify that the reservoir (30) is properly filled. The material of the reservoir (30) is compatible with the drug fluid and with the irradiation sterilization process. The reservoir (30) includes an inlet port (31) and an outlet port (33), the inlet port (31) being for direct connection to the syringe (12) or via a connector (22) to receive the drug fluid into the reservoir (30), and the outlet port (33) providing an outlet for a dispenser (28), such as a needle. The inlet port (31) and outlet port (33) may be formed of a double diaphragm, which may be bonded to the reservoir (30), for example, by heat fusion. The outlet port (33) may be configured such that a plug can block the outlet port (33) during the filling process. The outlet port (33) may be coupled to a dispenser (28), for example, in the form of a needle or a thin cannula.

[0101] The housing (26) may include an upright portion (32) for holding the reservoir (30). The upright portion (32) may be made of a suitable rigid material such as injection-molded plastic. A flat portion (34) may be provided around the upright portion (32), the flat portion (34) having a flat surface on its underside and having a flat adhesive sheet (36) disposed on the flat surface of the flat portion (34). The flat portion (34) may be at least partially flexible to bend when adhered to the user's skin. The adhesive sheet (36) may allow the dispensing unit (20) to remain on the user's skin for the duration of administration. The adhesive sheet (36) may be adhered to the user's skin in such a way that the adhesive sheet (36) is held in place until forcibly removed by tearing it off the skin. The flat portion (34) may include a tab (27) without adhesive. The tab (27) allows the user to easily remove the delivery device (10) from their skin by pulling the tab (27). This is particularly useful when the adhesive is designed for long-term wear where release may be more difficult. The tab (27) is configured to extend from one end of the dispensing unit (20) beyond the mating area of ​​the drive unit (24) for easy access, such as... Figure 1E As shown.

[0102] The dispenser (28) may be at least one needle or microneedle extending from the adhesive sheet (36) opposite to the upright portion (32). In some embodiments, at least one needle may comprise an array of hollow microneedles. Microneedles may be made of a variety of different materials, including silicon, titanium, stainless steel, and polymers. At least one needle may also be a common single steel needle, a Teflon infusion device, etc. As an example, the needle may be a stainless steel hypodermal injection needle with a length of 4 mm to 7 mm for percutaneous or subcutaneous administration of drug fluid.

[0103] A reservoir (30) may contact a plunger (38), which acts against the reservoir (30). The plunger (38) is axially movable within the reservoir (30) located in the upright portion (32) to apply pressure to the insulin within the reservoir (30). The reservoir (30) may be a rigid chamber, and the plunger (38) may have an attached O-ring seal that allows the plunger to slide relative to the rigid chamber. The rigidity of the chamber provides dispensing accuracy such that the positive displacement of the plunger (38) is proportional to the volume of fluid dispensed from the chamber.

[0104] In other embodiments, the plunger (38) may be formed from or integral with an exposed portion of the reservoir wall. The reservoir (30) itself may be formed of a flexible bladder, against which the plunger (38) acts to reduce the volume of the reservoir (30). In some embodiments, more than one bladder, such as a group of bladders, is located within the reservoir. The plunger (38) may be movable in a direction parallel to the plane of the planar portion (34) of the dispensing unit (20).

[0105] The plunger (38) is made of a material compatible with the drug fluid and sterilizable by radiation. The plunger (38) may have a shaft with an O-ring seal that provides a movable seal when engaged with the reservoir (30). The seal may be lubricated with a drug fluid compatible material. The plunger (38) is capable of moving in a first direction away from the reservoir (30) during filling of the reservoir (30) and is capable of moving in a second direction toward the reservoir (30) under the control of the drive unit (24) during the drug administration process.

[0106] The plunger (38) may have two parallel elongated portions (38) that move together to exert force on the wall of the reservoir (30). The housing (26) includes a guide member (39) in the form of a guide rail that engages with the protrusion of the plunger (38), wherein the guide member (39) has an end stop to restrict movement of the plunger (38) in a first direction during filling of the reservoir (30), thereby preventing overfilling of the reservoir (30). The guide member (39) may have a second end stop to restrict movement of the plunger (38) in a second direction to indicate when the reservoir is empty or too low to be accurately dispensed. The guide member (39) may interact with one of the plunger elongated portions (38), while the other elongated portion (38) may interact with the plunger operating member (70) of the drive unit (24). The housing (26) may also include a stabilizing rib (35) configured to be disposed across the end of the reservoir (30) to prevent axial movement of the reservoir (30) when it is mounted in the drive unit (24), thereby improving the accuracy of drug delivery.

[0107] The housing (26) of the dispensing unit (20) includes a engagement member (21) for engaging with the drive unit (24). The engagement member (21) holds the dispensing unit (20) engaged with the drive unit (24) until the user intentionally separates the dispensing unit and the drive unit. The engagement member (21) is designed so that the drive unit (24) can be top-loaded onto the dispensing unit (20) and separated from one end. Figure 2AIn one embodiment shown, the engaging member (21) on the dispensing unit (20) is in the form of two latching arrangements (23, 25), wherein the first latching arrangement (23) forms one or more downwardly extending and inwardly facing hooks at one end of the housing (26), and the second latching arrangement (25) forms one or more downwardly extending and outwardly facing hooks at the other end of the housing. A curved rigid portion (13) may extend beyond the first latching arrangement (23). This may be at the same end of the dispensing unit (20) as the non-adhesive tab (27) of the planar portion (34) configured for the user to remove the delivery device (10) from the body. The hooks may be molded together with the housing (26) without assembly. A corresponding capturing arrangement (29) is provided on the drive unit (24). In other embodiments, the engaging member (21) may include a tenon structure, a sliding structure, a locking structure, a friction fit structure, etc.

[0108] The planar adhesive sheet (36) can be formed of multiple layers of flexible material, such that the planar adhesive sheet (36) has a skin adhesive on one side and an adhesive with a more invasive component on the other side. The adhesive stack may include a segment (37) without adhesive, which can be used as a tab (27) to help remove the delivery device (10) from the user's skin. This can be achieved by covering the adhesive in that area or by using a third material without adhesive in the stack.

[0109] When removing the device from the skin, the retaining section (37) also facilitates the movement of the tab (27) for separating the dispensing unit (20) from the drive unit (24). The user uses the flexible tab (27) to peel the device from the skin in one direction and separates the drive unit (24) from the dispensing unit (20) by means of a peeling motion in a direction away from the tab (27). This helps prevent the latch from being released if the delivery device (10) wears out, as the body part prevents peeling in that direction. This also allows the user to peel the delivery device (10) from the body with a grip of one hand and, without changing that grip, use the other hand to hold the drive unit (24) and peel the drive unit (24) from the dispensing unit (20) in another direction.

[0110] Grasping the drive unit (24) and detaching it from the distribution unit (20) can disengage the two latch arrangements (23, 25) of the engagement member (21) by pulling the first latch arrangement (23) away from the capture arrangement (29) of the drive unit (24). The inwardly facing hook of the first latch arrangement (23) can be configured to disengage when the rigid portion (13) flexes in the opposite direction to the drive unit (24).

[0111] The adhesive sheet (36) may also include a release liner that can be removed during the manufacturing process to protect the integrity of the adhesive until it is assembled into the product. Alternatively, the release liner of the adhesive sheet (36) may be attached to a protective tray (19) (described further below) such that the release liner is removed from the adhesive sheet (36) when the delivery device (10) is removed from the protective tray (19).

[0112] Figure 3A A plan view of the allocation unit (20) is shown, and Figure 3B , Figure 3C and Figure 3D They show the crossings respectively Figure 3A The cross sections of lines AA, BB, and CC. Figure 3B The cross-section extends through the inlet port (31) and shows the elongated portion of the reservoir (30) and plunger (38) engaging with the guide member (39). The inlet port (31) includes a diaphragm (53) pierced by the needle of the connector (22). Figure 3C The cross section passes through the center of the dispensing unit (20) and shows the reservoir (30) and plunger (38). Figure 3C The cross-section also shows the capture arrangement structure (23, 25) that engages with the drive unit (24). Figure 3D The cross-section through the outlet port (33) shows the dispenser (28). The outlet port (33) includes a seal (55) which is pressed down by the plug (48) of the connector (22) to block the fluid path to the dispenser (28) during filling (e.g., Figure 5C (As shown).

[0113] Figure 4A An exploded view of the dispensing unit (20) and other components that can be packaged together as disposable parts is shown. These components include the dispensing unit (20), connector (22), protective tray (19), and top and bottom encapsulations (15, 17). The protective tray (19) protects the dispenser (28) and supports the dispenser (28) in place during the filling process. The top and bottom encapsulations (15, 17) can be in the form of a molded plastic tray and medical printing paper, and can be sealed to provide a sterile barrier, or alternatively provided as a gusseted pouch with medical printing paper. Figure 4B The sealed packaging before opening is shown.

[0114] Figure 5A , Figure 5B and Figure 5CA connector (22) is shown for use by a syringe (12), such as a syringe pen, during filling of the reservoir (30). The connector (22) guides the syringe (12) into the correct position and provides a fluid passage between the syringes (12). Once the reservoir (30) of the dispensing unit (20) has been filled with the syringe (12), the dispensing unit (20) can be discarded. The connector (22) may be a generally cylindrical or tubular component. The connector (22) may include a first engagement (42) and a second engagement (44), the first engagement (42) being connected at one end of the connector to a dispensing port (18) of the syringe (12) (e.g., the dispensing port may be a needle attachment point of a pen or syringe), and the second engagement (44) being connected at the opposite end of the connector to an inlet port (31) of the dispensing unit (20).

[0115] The first engagement (42) may include a releasable attachment mechanism for connecting to the dispensing port (18) of the syringe (12), such as a threaded connection, a tongue and groove arrangement, a friction fit, etc. The first engagement (42) may also include an internally disposed spear-like member in the form of a needle, a point, or a blade for piercing the fragile seal of the dispensing port (18) of the syringe (12), so that drug fluid from the syringe (12) can flow through the fluid channel within the connector (22).

[0116] The second engagement (44) may include a releasable attachment mechanism, such as a threaded connection, a tongue and groove arrangement, a friction fit, etc., through which the second engagement is releasably connected to the dispensing unit (20). In the illustrated embodiment, the second engagement (44) is a latching arrangement (46) that holds the connector (22) at the inlet port (31) on the housing (26) of the dispensing unit (20), wherein a pressing tab (47) for releasing the latch is provided. The second engagement (44) may include a groove (45) of the connector (22) configured to fit tightly into the upright portion (32) of the dispensing unit (20). As an alternative to the latch arrangement, the central portion of the extruded cylindrical member can slightly open the grooved end, thereby allowing the connector (22) to be removed from the dispensing unit (20) without applying a large pulling force, which would otherwise have caused the adhesive sheet (36) to detach from the dispensing unit (20). A second joint (44) can connect the fluid passage to the inlet port (31) of the reservoir (30) on the upright portion (32). The inlet port (31) may have a check valve to prevent insulin from leaving the inlet port (31).

[0117] Figure 5CThe connector (22) passes through the cross section of the connector (22) when it is attached to the dispensing unit (20) in the protective tray (19). The connector (22) may have a double-ended needle (41, 43) incorporated into the connector. The tip of one needle (43) pierces the diaphragm of the inlet port (21) of the reservoir (30) and allows the needle to seal when removed, while the other end (41) pierces the diaphragm (53) on the syringe (12), thereby allowing the user to fill the reservoir (30) from the syringe (12). The connector (22) does not need to be passed through into place; instead, there is a circular wall that guides the syringe (12) to the needle. The connector (22) has a clamping feature that allows the connector (22) to be removed from the inlet (31) of the reservoir (30) after the filling process.

[0118] The connector (22) includes a molded plug feature (48) that presses down on a second diaphragm or seal (55) of the reservoir (30) leading to the outlet port (33) connected to the dispenser (28), thereby blocking the fluid outflow path during filling. This prevents the drug fluid from leaving the dispenser (28) during the filling process. As the reservoir (30) is filled, the plunger (38) is pushed back according to the volume of drug fluid the user fills into the reservoir (30). This design allows the user to fill the reservoir (30) with a variable volume of drug fluid. As an example, the reservoir (30) is designed to be filled with up to 12 units of insulin.

[0119] The engagement portions (42, 44) of the connector (22) can be configured such that releasing its connection to the reservoir (30) is easier than releasing its connection to the syringe (12), allowing the syringe (12) to remain attached to the syringe (12) when the syringe (12) is pulled away from the reservoir (30). The connector (22) can be configured to be already attached to the dispensing unit (20). Alternatively, the connector (22) can be more easily released from its connection to the syringe (12), allowing the connector to remain in place on the reservoir (30) until it is removed. In both cases, a phased disconnection occurs.

[0120] The connector (22) allows the reservoir (30) to be filled directly from the syringe (12) without the need for an additional needle. In one example, the syringe (12) can be twisted into the connector (22), and the connector (22) separates from the syringe (12) from the reservoir (30) when the syringe (12) is twisted in the reverse direction. This is achieved by a stronger engagement at the syringe / connector joint than at the connector / reservoir joint. Once the syringe (12) is separated from the reservoir (30) together with the connector (22), the connector (22) can be removed from the syringe (12) and discarded. Alternatively, the engagement at the connector / reservoir joint can be stronger, and the syringe (12) can be separated from the connector (22), leaving the connector (12) attached to the reservoir (30), which can then be removed from the reservoir and discarded.

[0121] The reservoir (30) is manufactured such that the plunger (38) is fully inserted into the reservoir (30). The user dials the desired number of units and inserts the syringe (12) into the reservoir connector (22). The needle in the connector (22) pierces the septum on the syringe (12), allowing the reservoir to be filled with the drug fluid from the syringe (12). The user dispenses the drug fluid from the syringe (12) into the reservoir (30), and the plunger (38) retracts as the reservoir (30) is filled with drug fluid. This method minimizes air within the reservoir (30) and allows for variable filling of the reservoir (30) by the user.

[0122] Figure 6A and Figure 6B The drive unit (24) is shown in a top view, in which the cover is removed and disconnected from the dispensing unit (20). Figure 6C and Figure 6D The drive unit (24) is shown in a top view, in which the cover is removed and engaged with the dispensing unit (20), which can be seen through the upright portion (32) of the housing (26), and the reservoir (30) and plunger (38) are shown in the gap (54) of the drive unit (24).

[0123] The drive unit (24) is associated with the dispensing unit (20) and enables the drug fluid in the reservoir (30) to be pumped out through the dispenser (28). The drive unit (24) can be detachably attached to the dispensing unit (20), wherein the dispensing unit (20) is disposable, while the drive unit (24) is reusable. Thus, the drive unit (24) can be attached to the continuously used dispensing unit (20), wherein the drive unit (24) is reusable, and the dispensing unit (20) is disposable after use.

[0124] The drive unit (24) may include a housing (52) including a cavity (54), the upright portion (32) of the dispensing unit (20) including the reservoir (30) and the plunger (38) being tightly fitted in the cavity (54) when the dispensing unit (20) and the drive unit (24) are attached together, such as Figure 6C and Figure 6D As shown. The drive unit (24) can be driven by means of the drive unit (24) and as shown. Figure 2A The coupling member (21) on the dispensing unit (20) described and shown in the figure has a complementary structure to the dispensing unit (20) in a releasable manner.

[0125] In the illustrated embodiment, the outer surfaces of the dispensing unit (20) and the driving unit (24) can provide a smooth outer surface with a flat profile when connected. For example, the combined height of the dispensing unit and the driving unit (24) can be less than 10 mm, and preferably even less than 5 mm. The flat profile minimizes disruption to the user when the device is attached to the user's skin during use. In one example, the reservoir size can hold 120 microliters of drug fluid, and for a reservoir of this size, the volume range can be less than 20,000 mm². 3 And preferably less than 10000 mm 3 In a specific embodiment, the delivery unit (10) is approximately 13000 mm in size. 3 The volume can be 47×32×8.7mm (excluding the tabs (27)).

[0126] The drive unit (24) may include a plunger actuating member (70) capable of applying force to a plunger (38), which moves to provide pressure to a reservoir (30) to dispense a consistent increment of drug fluid, for example, in the case of insulin, this may dispense insulin in the range of 0.1 to 1.0 units per dispenser. When the dispensing unit (20) is connected to the drive unit (24), the reservoir (30) and plunger (38) of the dispensing unit (20) may be aligned with the plunger actuating member (70) such that the plunger actuating member (70) moves linearly to apply force to the plunger (38) and dispensing insulin from the reservoir (30) through the dispenser (28). It will be noted that in this embodiment, the plunger (38) is configured to have an axis extending generally parallel to the planar portion to allow the dispensing unit (20) to be connected to the drive unit (24) by means of a sliding action generally parallel to the planar portion (34).

[0127] In the illustrated embodiment, the drive unit (24) includes an integral drive mechanism (80) and a registration mechanism (90). In other embodiments, the drive mechanism (80) and the registration mechanism (90) may be separate components. For example, the registration mechanism (90) may include a separate reservoir volume sensor or other mechanism to detect the reservoir volume when the drive unit (24) engages with the reservoir (30) to be filled. The registration mechanism (90) determines the interaction between the drive unit (24) and the dispensing unit (20), particularly with the reservoir (30). The drive mechanism (80) operates a plunger (38) relative to the reservoir (30).

[0128] Such registration may include determining when the drive unit (24) and the dispensing unit (20) engage, determining the initial filling position of the reservoir relative to the “original” or reset position, and monitoring the liquid level in the reservoir during dispensing.

[0129] The drive mechanism (80) and the registration mechanism (90) are connected to the control unit (64), which includes a microcontroller processor and firmware, and controls the operation of the delivery device (10).

[0130] The drive mechanism (80) provides controlled movement of a plunger operating member (70) in the form of an arm (71), which moves linearly in the axial direction of the plunger (38) and has a lateral extension (72) that engages with the plunger (38). For a compact arrangement, the arm (71) can be arranged linearly adjacent to the reservoir (30) and the plunger (38). In the illustrated embodiment, the plunger operating member (70) is part of the registration mechanism (90) because it is used to determine the volume in the reservoir (30) and to operate to dispense drug fluid from the reservoir (30).

[0131] The plunger operating member (70) is driven by a drive mechanism (80) in the form of a stepper motor (81), which is combined with a transmission assembly (82) and a linear drive mechanism (83) connected to the arm (71) of the plunger operating member (70).

[0132] The plunger operating member (70) provides input to the registration mechanism (90), which determines the state and registration of the reservoir (30) relative to the drive unit (24). The registration mechanism (90) includes a rotary switch (91) that is rotatably coupled to an arm (71) of the plunger operating member (70) such that the arm (71) can slide through as the registration mechanism (90) translates.

[0133] The lateral extension (72) of the plunger operating member (70) has three orientations (92, 93, 94).

[0134] • Downward orientation (92) (in) Figure 6A and Figure 6B (As shown in the diagram) This occurs when the drive unit (24) separates from the dispensing unit (20). The lateral extension (72) is biased to a downward orientation (92) and returns to its original position when in the downward orientation (92). The original position is the retracted position corresponding to an empty reservoir and is used as a reference position. The plunger operating member (70) can be biased along the downward orientation, which is the default orientation, such that when the dispensing unit (20) separates from the drive unit (24), the plunger operating member returns to this orientation.

[0135] • Upward orientation (93) (in) Figure 6C (As shown in the figure) This occurs when the drive unit (24) first engages with the dispensing unit (20) and the plunger (38) and reservoir (30) are inserted into the gap (54) of the housing (52) of the drive unit (24). This causes the lateral extension (72) to be forced upward, so that the lateral extension (72) rests on the top of the plunger (38).

[0136] • Intermediate orientation (94) (in Figure 6D (As shown in the diagram) This occurs when the lateral extension (72) moves to the end of the plunger (38) and descends to engage the end surface of the plunger (38). This is the operating position prepared to dispense drug fluid by applying pressure to the plunger (38).

[0137] A rotary switch (91) or other suitable sensor in the form of a registration mechanism (90) is provided, which determines the orientation (92, 93, 94) of the plunger operating member (70) and provides a signal to the control unit (64). The registration mechanism (90) provides an indication of whether the dispensing unit (20) is attached to the drive unit (24). This is achieved by the rotary switch (91) sensing that the lateral extension (72) is in the downward orientation (92).

[0138] The registration mechanism (90) works together with the drive mechanism (80) to determine the initial plunger (38) position, known as the initial registration position. Once dispensing has begun, the registration mechanism (90) and the drive mechanism (80) can indicate at any time how much drug fluid is present in the reservoir.

[0139] Reference Figures 7A to 7E A series of figures illustrate the operation of the registration mechanism (90) and the drive mechanism (80).

[0140] Figure 7AThe first stage (110) is shown when the dispensing unit (20) is first attached to the drive unit (24). The drive unit (24) engages with the dispensing unit (20) by pressing the drive unit (24) directly downward onto the dispensing unit (20). When the drive unit (24) engages with the dispensing unit (20), the plunger operating member (70) rotates from a downward orientation (92) to an upward orientation (93) and is supported by the plunger (38). This indicates that the dispensing unit (20) has been connected, but the plunger (38) has not yet been located. The lateral extension (72) of the plunger operating member (70) is pushed by the plunger (38) along the upward orientation (93) when the plunger (38) is placed in the gap (54) of the drive unit (24). The rotary switch (91) indicates this state to the control unit (64). The plunger operating member (70) will be in the fully retracted position during this stage, as it will be reset to its original position corresponding to the empty reservoir before the dispensing device (20) is attached. This reset only occurs when the drive unit (24) is on the charger unit, as this ensures that the dispensing unit (20) is not attached, since resetting to the original position requires movement in the dispensing direction and this avoids any unintentional dispensing in the event of a control error.

[0141] Figure 7B and Figure 7C The next stage (120, 130) is shown, in which the lateral extension (72) of the plunger operating member (70) is moved upwardly (93) along the lateral extension (72) by a drive mechanism (80) under the control of the control unit (64). Initial registration to find the filled reservoir volume is achieved by the drive mechanism (80) moving the plunger operating member (70) in a direction opposite to the dispensing direction (121). The device is designed such that the position of the plunger operating member (70) can be found by moving it in a direction opposite to the direction required for fluid flow. If a position detection failure occurs, the system will stop operating without dispensing any drug fluid to the user. This provides a safety feature to ensure that no dispensing occurs during the initial registration process.

[0142] The registration mechanism (90) determines that the plunger operating member (70) is in an upward orientation (93), and then uses the drive mechanism (80) to drive the plunger operating member (70) in a direction opposite to the plunger dispensing direction (121), such that the lateral extension (72) of the plunger operating member (70) moves along the top of the plunger (38) until the lateral extension (72) reaches the end of the plunger (38), as... Figure 7B As shown. The lateral extension (72) of the plunger operating member (70) then descends (131) to the intermediate orientation (93), as... Figure 7CAs shown, this aligns the position of the end of the plunger (38). The intermediate orientation (94) is determined by the rotary switch (91), which also indicates to the control unit (64) that the drive unit (24) is now connected and the plunger operating member (70) is at the end of the plunger (38). The distance by which the lateral extension (72) of the plunger operating member (70) moves from its original position to the position at the end of the plunger (38) can be determined by the movement distance of the plunger operating member (70). This distance is determined by the stepping of the stepper motor (81) required to move the plunger operating member (70) from its original position to the plunger position.

[0143] Figure 7D The next operational phase (140) is shown. Once the plunger operating member (70) is in the intermediate orientation (94), this is detected by the rotary switch (91). The drive unit (24) is activated to expel air and remove slack in the system by moving a predetermined distance in the dispensing direction, as further described below. Once activated, the plunger operating member (70) is in the initial registration position, at which the initial volume of the reservoir (30) can be calculated. The initial registration position can be determined by subtracting the activation distance moved along the second position from the distance moved along the first direction to find the plunger end. The volume in the reservoir (30) can be calculated based on the distance while taking into account the geometry of the reservoir (30).

[0144] The plunger operating member (70) is then controlled to dispense drug fluid from the reservoir by applying pressure to the plunger (38) in the dispensing direction (141). The timing and amount of dispensing are controlled by the control unit (64). The position of the plunger operating member (70) is tracked by monitoring the step position from the original position. The amount of movement required for the plunger operating member (70) to dispense a defined amount of drug fluid is controlled by the control unit (64) via the number of steps of the stepper motor (81).

[0145] Figure 7E The final stage (150) is shown, in which the dispensing unit (20) has been removed from the drive unit (24), causing the lateral extension (72) of the plunger operating member (70) to return to its biased downward orientation (92), which is detected by the rotary switch (91). In addition to the indication by the rotary switch (91), the control unit (64) senses when the drive unit (24) is attached to the charger to recharge the battery power of the drive unit, and the control unit (64) resets the plunger operating member (70) to its original position where the plunger operating member is fully retracted in the dispensing direction (151).

[0146] In an alternative embodiment for locating the plunger relative to the filled reservoir, the plunger actuating member can be moved by a drive mechanism to use a drive current sufficient to move the plunger independently, but not enough to move the plunger actuating member and the plunger together. Once the plunger actuating member reaches the plunger, the motor stalls, and the control unit detects this stall. In the case of a stepper motor, this results in a detectable voltage due to magnetic pole mismatch caused by motor stall. This motor stall circuit can be integrated into a stepper motor driver chip. The control unit can count the number of steps to the stall point, which can be converted into the registration distance and filled volume of the reservoir. Once the initial registration position has been determined, the motor can operate at full current to drive the plunger and dispense fluid. The difference between the force required to move the plunger actuating member and the force required to move the plunger actuating member and the plunger together must be sufficient to distinguish the action. Friction elements may be needed to emphasize this difference.

[0147] Another alternative implementation uses a switch employing mechanical, optical, magnetic, inductive, or capacitive technologies to determine the plunger position and the proximity of the plunger operating mechanism to the plunger end. The switch can be calibrated during assembly by driving the mechanism into a hard stop and determining the number of steps between the switch trigger and the motor stall on the hard stop. This number can then be written to memory and used to improve the switch's accuracy.

[0148] Once the plunger operating member (70) is aligned with the end of the plunger (38), the control unit (64) can control the drive mechanism (80) to activate the delivery device (10) by moving a calibration distance, thereby moving the plunger (38) in the dispensing direction. Slack in the device is caused by searching for plunger position, component compressibility, and air in the system. Activation can remove slack or air from the system and can resolve compression losses before dispensing fluid via the distributor (28). The drive mechanism will move a fixed distance (number of steps) to remove slack from the device. The number of activations for a design can be determined by evaluating the number of steps required to activate the drive unit (24) or by individually measuring the number of steps required for each drive unit (24) and storing that value in the device during manufacturing.

[0149] The conventional method for initiating a needle-based system is to push until fluid is dispensed from the needle. To ensure that no drug fluid is delivered during the initiation process, the initiation process under-starts the pump to account for tolerances to ensure that no insulin is dispensed. Other steps of the initiation process may occur during the first delivery of drug fluid by absorbing any remaining slack based on empirical testing and tolerance analysis. Under-starting is possible due to the small amount of air present in the dispensing unit and for transdermal or subcutaneous administration. Therefore, under-starting is designed to expel as much air as possible without dispensing any drug fluid. The control unit (64) may determine the distance (e.g., the number of steps of a stepper motor) required for the process by moving the plunger (38) based on empirical testing and tolerance analysis. Calculating the number of steps for initiation and the first delivery ensures that the delivery device (10) is accurate, as initiation will primarily occur on the body. Initiation may take some time to complete, and the user may have already applied the delivery device (10) to their skin during this time; therefore, under-starting is a safety feature to ensure that no drug fluid is delivered to the user during initiation.

[0150] When determining the distance (e.g., the number of steps of a stepper motor) required to dispense a defined volume, the control unit (64) can take into account the geometry of the reservoir (30). For example, if the reservoir (30) is tapered or has a draft angle due to molding, the number of steps can increase as the reservoir tapes closer together, thus requiring a larger linear motion to dispense a unit of fluid. The distance-to-volume conversion can be determined using an equation or lookup table to determine the distance-to-volume conversion, depending on the location along the reservoir.

[0151] The movement of the plunger operating member (70) is monitored by the control unit (64) during dispensing and it is determined when the dispensing process is close to emptying. This is achieved by determining the number of steps moved by the stepper motor (81) to monitor the volume in the reservoir (30).

[0152] The drive mechanism (80) may also include a stall detection mechanism (83) that detects motor stall due to obstruction or emergency stop of the movement of the indicator plunger (38) of the motor (81). If the motor stall is due to emergency stop or obstruction, the control unit (64) can interpret the monitored reservoir volume and provide appropriate warnings.

[0153] The control unit (64) works with the stepper motor (81) by generating stepping pulses and direction signals for the stepper motor (81). The stepper motor (81) is an electromagnetic device that converts digital pulses into rotation of a mechanical axis, which is then converted into linear motion via a transmission assembly (82) and a linear drive mechanism (83).

[0154] The drive mechanism (80) may include a telescopic linear drive mechanism (83), such as a helical driver, which may be driven by a transmission assembly (82), which in turn is driven by a stepper motor (81). The stepper motor (81) may be powered by a power source that may include a battery (62), such as a rechargeable battery. The drive unit (24) may also include electrical contacts (not shown) that are connected to complementary electrical contacts of a recharging base station (not shown) to allow the battery (62) to be recharged by the base station when the drive unit (24) is disconnected from the distribution unit (20).

[0155] Another safety feature is provided whereby, when the drive unit (24) is charging, the plunger operating member (70) only resets to its original position, which is the fully retracted position corresponding to an empty reservoir (30). There is a risk of fluid being dispensed to the user if the plunger operating member (70) is unintentionally reset to the fully retracted position by movement while the drive unit (24) is still attached to the dispensing unit (20). Therefore, a safety feature is provided to ensure that reset is only possible when the drive unit (24) is on the charger.

[0156] In the illustrated embodiment, the drive unit (24) is a modular unit including a drive mechanism (80), a power supply, and a control unit (64). The control unit (64) can be located within the cover (66) of the drive unit (24). Figure 2A The component (shown in the diagram) is housed in a generally shallow compartment within the drive unit, and may include a printed circuit board with control electronics and a communication antenna (not shown). The control electronics may include power electronics, wireless communication electronics, a processor, and optionally, encryption microprocessors, temperature sensors, and jamming sensor circuitry.

[0157] Reference Figure 8 The block diagram illustrates an example implementation of the drive unit (24). The drive unit (24) includes a control unit (64) and a wireless communication module (250) for communicating with a user device (201), such as a mobile phone, laptop computer, or desktop computer, via a wireless network (260) and / or for communicating with a patient monitor (202), such as a continuous glucose monitor (GCM). The control unit (64) can determine when to administer the drug fluid to the user by means of information received from the patient monitor (202) or from the user device (201). The control unit (64) can also be configured to generate status indications or alerts and transmit these indications / alerts to the user device (201) and / or to have such indications / alerts displayed or indicated by the drive unit (24) itself, for example, through a flashing light, sound, and / or haptic feedback.

[0158] The control unit (64) includes firmware (212) and a microcontroller in the form of a processor (211) that controls the operation of the drive unit (24). The firmware (212) is provided by a number of components of the control unit (64). The processor (211) may be a hardware module or circuit for performing the functions of the components, and the components may be software units executing on at least one processor (211). The memory may be configured to provide computer instructions to the processor (211) to perform the functions of the components.

[0159] The control unit (64) includes a registration component (220) for registering the drive unit (24) with the attached dispensing unit (20). The registration component (220) includes a connection component (221) for detecting when the dispensing unit (20) is attached to the drive unit (24). The registration component (220) includes an initial position component (222) for detecting the initial filling position of the reservoir and plunger of the dispensing unit (20) relative to the drive unit (24). The registration component (220) includes a position monitoring component (223) for detecting the position of the plunger of the dispensing unit (20) during dispensing operations.

[0160] The registration unit (220) can determine the volume of drug fluid in the reservoir based on the position of the plunger determined by the registration mechanism (90) using the plunger operating member (70). A rotary switch (91) (or other status indicator or sensor) of the registration mechanism (90) can provide the registration unit (220) with indications of the plunger status and position. The registration unit (220) can determine the volume of the reservoir according to its dimensions and geometry to convert the linear movement of the plunger into fluid volume.

[0161] The control unit (64) includes a dispensing algorithm component (213) that can communicate with the user device (201) and / or the patient monitor (202) and determine when to dispense a dose using the dispensing unit (20). In the example where the drug fluid is insulin, the dispensing algorithm component (213) determines when to deliver the dose and calculates the amount of insulin in the user's body.

[0162] The control unit (64) includes a drive control unit (217) for controlling the drive mechanism (80) according to the allocation algorithm unit (213). This can control the drive mechanism (80) to operate the stepper motor (81) to move the plunger actuating member (70) via the transmission assembly (82) and the linear drive mechanism (83). The drive control unit (217) can also operate under the control of the registration unit (220) to find the initial registration position by driving the drive mechanism (80) in the opposite direction of allocation.

[0163] The control unit (64) includes an initialization component (214) for initializing the dispensing algorithm component (213) to assume that the patient has a basic level of drug fluid and to reduce the assumed amount over time.

[0164] The control unit (64) includes an actuation component (215) that works in conjunction with a drive control component (217) to activate the dispensing unit (20) by moving the plunger a calibration distance without dispensing any drug fluid. The actuation component (215) can be calibrated during the manufacture of the device.

[0165] The control unit (64) includes a reset component (216) for resetting the plunger operating member (70) when it is determined that the dispensing unit (20) is no longer attached to the drive unit (24). This includes receiving a signal from a recharge contact (254) of the drive unit (24) for recharging the power supply (253) from an external source. The reset component (216) can work in conjunction with the drive control component (217) to move the plunger to its original position in the fully retracted position.

[0166] The drive unit (24) also includes a drive circuit (251) and a power management circuit (252) that can be disposed on the same printed circuit board as the control unit (64). The power management circuit (252) may include a power monitor, a boost converter, and a power-on reset control circuit located on the printed circuit board. The drive unit (24) may include a steel plate that allows the charger to hold the drive unit (24) in place using magnets during charging.

[0167] The drive unit (24) also includes a stall detector (255) for stall detection, which is used for blockage detection and termination of travel detection. This can provide a signal to the control unit (64).

[0168] The stepper motor (81) and transmission assembly (82) provide accurate distance measurement, and the linear drive mechanism (83) can be a lead screw driver that converts the rotary drive of the stepper motor into linear motion. The control of the drive mechanism (80) uses a sequence that reduces the possibility of unintentional operation. An alternative implementation may use a DC motor.

[0169] Because the motor and lead screw are elongated, the reservoir (30) and drive mechanism (80) are arranged side by side. This is achieved by placing a plunger actuating member (70) on the end of the lead screw and retracting the lead screw to expel the drug fluid from the reservoir (30). The plunger actuating member (70) is designed to contact the plunger and push the plunger as the stepper motor (81) advances to drive the drug fluid out of the reservoir. The plunger actuating member (70) rotates to achieve position sensing and connection sensing.

[0170] The power source (253) can be a lithium rechargeable battery, such as a lithium polymer (LIPO) battery with a small capacity (10-20mAh) and a high discharge rate (10C). Since most of the power is consumed in a short period of time when the motor needs to move, the battery needs to be too large to last all night or have a high discharge rate.

[0171] The rotary switch (91) provides a three-position sensor (disconnect, connect, connect / pusher end) that combines the operation of two sensors into one mechanism. This detects when the drive unit (24) is connected to the dispensing unit (20) and also detects the position of the plunger operating member (70) during operation.

[0172] A charger unit, such as a desktop lithium-ion battery charger, can be provided that aligns with the drive unit (24) and maintains electrical contact with the charger unit while it is charging. Features of the charger unit include spring-loaded charging pins and a magnet to provide a holding force to keep the drive unit (24) against the charging pins. The charger unit may have a weighted bottom and / or a buffer to grip surfaces so that the charger does not slip off a table. The charger unit may include a USB connector that plugs into a wall charger or computer (alternatively, a user-replaceable battery can be used for charging). The charger unit may indicate when it is charging (i.e., a flashing LED) and when it is charged to a percentage greater than a certain percentage (i.e., a solid-state LED when charging exceeds 80%). An 80% charge level is considered sufficient to operate the device, and charging to that level will occur quickly because lithium-ion batteries are typically in constant-current mode. Charging above 80% typically operates in a slower, constant-voltage mode.

[0173] Reference Figure 9 The flowchart (300) shows an example implementation of the method performed by the control unit (64) of the delivery device (10).

[0174] This method can detect (301) that the drive unit is being charged and that, during charging, the plunger operating member (referred to as the operating member in the figure) is fully retracted to its reset original position. This can be detected by a sensor of the registration mechanism (such as a rotary switch (91)).

[0175] This method can detect (302) the attachment of the refilling dispensing unit to the drive unit (24). This can be detected by a sensor when the dispensing unit moves the actuating member to an upward orientation, provided that the reservoir and plunger are inserted into the gap of the drive unit. The method can control (303) the movement of the actuating member in a first direction opposite to the dispensing direction of the actuating member until the actuating member descends to an intermediate orientation at the end of the plunger. Once the dispensing unit (20) is attached to the drive unit (24), the device can be applied to the user's skin.

[0176] This method can be used to activate (304) the delivery device by moving the actuator a predetermined distance in a second direction that serves as the dispensing direction. The distance moved is calibrated to tighten the device without dispensing any drug fluid. The method can determine (305) the volume in the reservoir at the initial registration position based on the distance the motor moves the actuator against the delivery direction from the original position to the initial registration position, taking into account the activation distance. Once the delivery device is attached to the user's skin, activation (304) and locating the initial registration position (305) can be performed.

[0177] The method may receive (306) patient information from a user device and / or a patient monitor during the method, and may incorporate the received information into the dosing algorithm. The method may transmit (307) alerts and information to the user device and / or display alerts on the control unit. Receiving (306) and transmitting (307) information may occur before dosing and throughout the dosing period.

[0178] This method can initialize (308) the dose to assume a baseline level of the drug in the patient's body (e.g., the amount of insulin in the body) and apply a reduced drug level over time. The method can initiate controlled dispensing of the drug fluid (309) according to a dosing algorithm, thereby moving the actuator a distance determined based on the desired dose volume along a second direction.

[0179] The method can detect (310) the disconnection of the drive unit from the distribution unit and can detect (311) the attachment of the drive unit to the charging unit, thereby causing the operating member to reset so as to retract the operating member to its original position in the second direction.

[0180] A dosing algorithm is configured in the control unit (64). In the case of insulin, this is a corrective dosing algorithm that runs when new glucose readings become available (typically these readings are provided by the CGM every 5 minutes). The dosing algorithm calculates the in-flight insulin (IOB) (based on a decay model over time) and calculates the user's insulin sensitivity based on information about the user's long-acting insulin use. This information is used to calculate the required amount of insulin to be administered to the user. If insulin information is available, the initial IOB can be calculated and used in the algorithm. If no information is available, the algorithm assumes the initial IOB corresponds to a glucose reading, in which case insulin is not required. Over time, the IOB decays and the control system corrects for any discrepancies between the glucose reading and the IOB.

[0181] The distance (number of steps) the plunger (38) is pushed during the first administration will be greater than the nominal distance to account for under-start. The increased number of steps will be determined by testing statistically significant sample sizes.

[0182] The distance (number of steps) the plunger (38) is pushed during subsequent drug administration can be variable to account for the draft angle on the reservoir. The manufacture of some molded parts requires a draft angle to properly release the part from the mold. This draft angle can be in the range of 0-1 / 2%, and without compensation, it may have an error of up to + / -5% over the length of the chamber.

[0183] The control unit (64) knows the position of the plunger operating member (70) and the approximate end point of the plunger (38). At the last administration, the control unit (64) can stop or drive the plunger (38) at a known position until the plunger (38) reaches the hard stop by monitoring the stall event motor. The control unit (64) monitors the number of steps and converts the number of steps into the dosage for the last administration. Since it is preferable to use all available drug fluids, the last administration can be any remaining drug fluid in the reservoir (30), which will be less than the nominal dosage.

[0184] Once this period is complete and the drive unit (24) is disengaged from the dispensing unit (20), the wearable dispensing device (10) is removed from the body. Once this is complete, the control unit (64) will be aware of this and will reset the mechanism to its original position. However, this movement is along the direction of fluid flow, and therefore, in the presence of a sensing malfunction, this could result in the contents of the reservoir (30) being dispensed. A preferred method is to reset the registration mechanism and drive mechanism once the drive unit (24) is placed on the charging unit, as the system cannot dispense fluid to the user while the drive unit (24) is on the charging unit.

[0185] Once the drive unit (24) is placed on the charger unit, the registration mechanism and drive mechanism can retract to their original positions. The drive unit (24) can use the number of steps from this original position for all distance measurements, and a stall detection on the stepper motor can be used to detect hard stops (similar to limit switches) in case of errors in the number of steps. This eliminates the need for an encoder to detect the position.

[0186] The lithium battery of the drive unit (24) can be charged by placing it on the charger unit, where the pins are in contact with the charger unit. This process may take several hours to complete. The charger unit can indicate when the battery is being charged and when it is fully charged for use.

[0187] Figures 10A to 10F A series of diagrams are shown for the preparation of the dispensing device (10), and Figure 11 A flowchart (400) illustrates a method for delivering a drug fluid to a user using a delivery device (10). Figure 10A As shown, the dispensing unit (20) can be pre-packaged with a connector (22) already attached to the dispensing unit (20) and included in a sterile package (not shown). Once removed from the sterile package, the syringe (12) is releasably attached (401) to the dispensing unit (20) by means of a first engagement (42) of the connector (22), which is connected to the dispensing port (18) of the syringe (12). A spear-shaped element located within the first engagement (42) pierces the fragile seal of the dispensing port (18) of the syringe (12), such as at a needle attachment point, to allow drug fluid to move from the syringe (12) to the dispensing unit (20). In one embodiment, the drug fluid is insulin and the syringe (12) is an insulin pen.

[0188] Reference Figure 10B The user moves a variable amount of drug fluid (e.g., less than 12 units in the case of insulin) on their syringe (12) and actuates (402) the syringe (12) to inject the drug fluid directly into the reservoir (30) of the dispensing unit (20) by pressing the injection button (14) on the insulin pen (12) to fill the reservoir (30).

[0189] In one embodiment, the user then applies (403) the adhesive sheet (36) of the dispensing unit (20) to the user's skin, where the dispensing unit (20) can be used for transdermal or subcutaneous insulin administration. A syringe (12) can be used to apply the dispensing unit (20) to the user's skin before attaching the driving unit (24) to the dispensing unit (20). The syringe (12) can hold the dispensing unit (20) firmly in place and apply force against the skin to cause the dispenser (28) (e.g., at least one needle) to pierce the user's skin and result in stable attachment of the adhesive sheet (36). In an alternative embodiment, the user uses their hand to apply the dispensing unit (20) as described above. Figure 10F The fully assembled dispensing unit (10) shown is applied to (403) the user's skin.

[0190] Figure 10C The next stage is illustrated, in which the syringe (12) with the attached connector (22) is retracted, and the connector (12) is separated from the dispensing unit (20) by separating the second engagement (44) of the connector (22) from the dispensing unit (20). To aid in disconnection, the user can squeeze the center portion of the connector (22) to open the slot (54) on the connector (22) as previously described, or to release the attachment device. Figure 10D The next stage shown is to detach the connector (22) from the syringe (12) by separating the first engagement (42) of the pen connector (22) from the dispensing port (18) of the syringe (12), for example by unscrewing the connector (22). The connector (22) can then be discarded.

[0191] exist Figure 11 In the alternative sequence shown, the method can detach the syringe (12) from the connector (22) (403), and then detach the connector (22) from the dispensing unit (20) (404) and discard the connector (22).

[0192] The drive unit (24) is then attached to the distribution unit (20) (405). Figure 10E In the illustrated embodiment, this is done by sliding the drive unit (24) into place. In other embodiments as described above, this can be done by vertically engaging the drive unit (24) onto the dispensing unit (20). The delivery device (10) is then applied to (406) the user, causing the dispenser (28) to pierce the user's skin.

[0193] Once such Figure 10FWhen connected as shown, the insulin delivery device (10) is automatically powered on via the connection of the sensing drive unit (24) to the dispensing unit (20), or by means of user interaction, such as via a switch located on the drive unit (24) or a wireless instruction received from the user device. The device (10) then automatically operates through a series of system checks to ensure that the device is ready without any user intervention. Such system checks may include a power check, checking for the presence of drug fluid in the reservoir (30), and checking that the device is communicating with connected devices such as a patient monitor.

[0194] The drive unit (24) can be configured to automatically activate the dispensing unit (20) by actuating the drive mechanism to purge any known amounts of air that may be present. Once activated, the insulin delivery device (10) is ready to begin. Figure 11 The final stage shown is the delivery of (407) insulin to the user.

[0195] A schedule for administering a drug fluid to a user can be determined by instructions recorded on or by the control unit (64), which may be based on information received from the user device and / or patient monitor. This information may include the type of drug fluid that will determine the dosing schedule. In one embodiment, the drug fluid is insulin, and the patient monitor is a continuous glucose monitor (CGM). The control unit (64) can therefore be configured to wirelessly pair with a dedicated or proprietary CGM system. Obtaining information from the paired CGM system enables the device to follow an onboard predictive algorithm (or one provided by an external system similar to the user device) rather than simply following a static schedule. The predictive algorithm may take into account information received from the CGM system, including past, current, and predicted future blood glucose levels, and may use machine learning to improve its accuracy over time as it acquires more data on a particular user. Based on the predictive algorithm, the device then administers a varying amount of insulin to the user.

[0196] After a predetermined administration time, such as overnight, throughout the day, or part of the day, the user simply removes (408) the adhesive sheet (36) from their body using an adhesive-free label (27). The user then separates the drive unit (24) from the dispensing unit (20) (409) and places (410) the drive unit (24) on the charging station. The dispensing unit (20) itself is discarded. The mechanism for retracting and / or bending the dispenser (28) can also be achieved by means of a latching mechanism (not shown) that covers the dispenser to reduce the risk of accidental puncture.

[0197] The delivery device (10) can be used continuously by continuous application over a period of time, intermittently by application and non-application periods, or periodically by continuous and / or intermittent use over multiple wearing periods.

[0198] To keep the cost of the device low, it is intended to be used for a period of time typically less than a day, such as 8 to 12 hours. This allows for the use of a smaller battery compared to devices intended to operate for longer periods, such as days or weeks. The intention is that the reservoir is only filled once, so the device dispenses only a certain volume of insulin from the reservoir (30) over a set period of time until a new dispensing unit (20) is needed.

[0199] The delivery device (10) can work with any type of pre-meal insulin and any type of insulin pen without requiring any additional medical prescription from the user. The dispensing unit (20) can be manufactured as a low-cost device with a smooth, low profile, which is significantly less invasive than existing insulin pumps. In this way, the insulin delivery device (10) provides a tablet pump for discontinuous delivery of insulin, where the insulin is already supplied by the user's preferred insulin pen.

[0200] Advantageously, this product offers insulin pen users an automation feature, which can be particularly beneficial at night or when the user does not want or cannot receive medication regularly. This allows the user to sleep through the night and wake up with more stable blood sugar levels, and increases the time blood sugar stays within a certain range (the time blood sugar levels are measured within the desired range).

[0201] Insulin pens are primarily used to control high blood sugar (by adding insulin); low blood sugar is addressed by eating something. This device helps manage high blood sugar, which remains a major concern at night. In some implementations, the device can communicate with a wearable blood glucose meter to determine when and how much insulin to administer.

[0202] An example use of the delivery device (10) will now be described in the context of insulin delivery. Jane is a type 1 diabetic patient who uses a smart insulin pen to obtain insulin by injecting multiple times a day. She has been able to control her blood sugar during the day, but she often tends to have higher than target in the early morning while she is sleeping. After consulting with her doctor, she uses the delivery device (10) described herein to better control her high blood sugar at night. She received a package with durable parts that house the drive unit (24), the charging unit, and the USB cable. She places the drive unit (24) on the charging unit and uses the USB cable to connect the charging unit to a wall plug. Jane also received a box with multiple disposable units that include a dispensing unit (20) and a connector (22) set on a protective tray (19). The disposable units are packaged in a way that... Figure 4B In the top and bottom packages (15, 17) shown.

[0203] At night, Jane unpacked one of the packages and removed the dispensing unit (20). She dispensed 10 units from her rapid-acting insulin pen, inserted the pen into the connector (22), and filled the reservoir with 10 units of insulin. She removed the connector (22) from the reservoir and discarded it into a sharps container.

[0204] Jane removes the drive unit (24) from the charger unit and snaps the drive unit (24) onto the distribution unit (20) to connect the two wearable pieces. She peels the protective bottom package (17) off the distribution unit (20) and is now ready to apply the piece to her body.

[0205] Jane slept soundly through the night, and she checked her user device, which took the form of her smartphone, and could see her CGM chart with hash marks at the time of administration. Her blood sugar reading was within the target range. Satisfied, she removed the tablet, discarded it into a sharps container, and continued her day.

[0206] The above description has been presented for illustrative purposes; it is not intended to be exhaustive or to limit the invention to the precise forms disclosed. Those skilled in the art will understand that many modifications and variations are possible based on the above disclosure.

[0207] The language used in this specification has been chosen primarily for readability and instruction purposes, and may not have been chosen to define or limit the inventive subject matter. Therefore, it is intended that the scope of the invention is not limited by this detailed description, but rather by any claims issued based on the application based on this invention. Thus, the disclosure of embodiments of the invention is intended to be illustrative and not to limit the scope of the invention.

[0208] Finally, unless the context otherwise requires, throughout the specification and appended claims, the word “comprising” or variations such as “including” or “comprising” shall be understood to mean including the whole or group of wholes, but not excluding any other whole or group of wholes.

Claims

1. A drug fluid delivery device, comprising: A dispensing unit having a dispenser for delivering drug fluid to a user and a reservoir configured to be filled with a variable amount of drug fluid received from a drug fluid injector, the dispensing unit including a plunger movable relative to the reservoir to apply pressure to the drug fluid in the reservoir to pump the drug fluid through the dispenser. as well as A drive unit, which can be attached to the dispensing unit, includes a control unit that controls the drive unit and causes the drug fluid in the reservoir to be pumped through the dispenser. The drive unit includes a plunger actuating member configured to engage with the plunger and be driven by a drive mechanism. The drive unit includes a registration mechanism that is integrated with the plunger operating member and configured to detect the position of the plunger of the dispensing unit to determine the state of the reservoir by means of the orientation and position of the plunger operating member. The state includes the presence of the reservoir and the initial level of the drug fluid in the reservoir.

2. The drug fluid delivery device according to claim 1, wherein, The registration mechanism includes sensors regarding the state of the reservoir, and wherein the state of the reservoir further includes one or more of the following: the reservoir is present, the reservoir is engaged but not ready, and the current liquid level of the filled reservoir.

3. The drug fluid delivery device according to claim 1, wherein, The registration mechanism determines the position of the initial filling state of the reservoir by moving the plunger operating member in the opposite direction to the direction of dispensing the drug fluid.

4. The drug fluid delivery device according to claim 1, wherein, The registration mechanism detects when the allocation unit is attached to the drive unit.

5. The drug fluid delivery device according to claim 1, wherein, The registration mechanism is used by the control unit to determine the volume of the drug fluid in the reservoir based on the position of the plunger operating member.

6. The drug fluid delivery device according to claim 1, wherein, The registration mechanism determines the original position of the plunger operating member as a reference for the empty state of the reservoir, and determines the initial registration position of the plunger operating member as a reference for the filled state of the reservoir.

7. The drug fluid delivery device according to claim 1, wherein, The drive mechanism includes a stepper motor for controlling and measuring the linear motion of the plunger actuating member, and the control unit controls the delivery amount of the drug fluid by actuating the stepper motor in steps.

8. The drug fluid delivery device according to claim 1, wherein, The plunger operating member is configured to actuate a sensor in a separation state when the dispensing unit is separated from the drive unit, and to actuate an operating state when the plunger operating member engages with the plunger to prepare for delivery of the drug fluid.

9. The drug fluid delivery device according to claim 8, wherein, The plunger operating member is configured to have a first orientation that depends on and indicates when the drive unit separates from the dispensing unit and a second orientation that engages with the plunger and indicates the operating state.

10. The drug fluid delivery device according to claim 9, wherein, The plunger operating member is configured to have a third orientation, which is caused by the engagement of the dispensing unit with the driving unit and indicates a standby state ready for registration to result in the second orientation.

11. The drug fluid delivery device according to claim 1, wherein, The control unit is configured to automatically activate the plunger operating member by moving a predetermined activation distance in the plunger delivery direction to under-activate the drug fluid, such that no drug fluid is delivered during the activation phase.

12. The drug fluid delivery device according to claim 11, wherein, The control unit determines that the distribution unit is attached to the drive unit and controls the plunger operating member to automatically start the plunger operating member and find the initial position.

13. The drug fluid delivery device according to claim 1, wherein, The control unit is configured to reset the plunger operating member by moving the plunger operating member to its original position along the plunger delivery direction when the control unit receives an instruction that the drive unit is connected to the charger unit.

14. The drug fluid delivery device according to claim 1, wherein, The drive unit includes electrical contacts that are connected to complementary electrical contacts of a recharging base station to allow power to be recharged through the base station when the drive unit is disconnected from the distribution unit.

15. The drug fluid delivery device according to claim 1, wherein, The control unit includes a wireless communication module for communicating with a remote device for receiving information used by the drug delivery algorithm of the control unit to control the delivery of the drug fluid from the dispensing unit.

16. The drug fluid delivery device according to claim 1, wherein, The drive mechanism includes a stall detector for detecting motor stall caused by obstruction in fluid delivery or a sudden stop in the movement of the plunger.

17. The drug fluid delivery device according to claim 1, wherein, The control unit is configured to initialize the plunger operating member by sensing that the dispensing unit is attached to the drive unit and controlling the drive mechanism to move in a first direction opposite to the plunger delivery direction until the plunger operating member engages with the end of the plunger.

18. The drug fluid delivery device according to claim 1, wherein, The control unit is configured to generate status indications or warnings and transmit these indications or warnings to the user device and / or to have the indications or warnings displayed or indicated by the drive unit itself.

19. The drug fluid delivery device according to claim 1, wherein, The reservoir is configured to be filled from an autoinjector for automatic dispensing of a pre-selected amount of drug fluid.

20. The drug fluid delivery device of claim 1, further comprising a connector configured to releasably attach the dispensing unit to the drug fluid injector, wherein, The connector includes a first engagement configured to be coupled to the syringe and a second engagement configured to be coupled to the dispensing unit, wherein the second engagement includes a sealing arrangement configured to block a fluid path to the dispenser during filling of the reservoir.

21. The drug fluid delivery device according to claim 20, wherein, The reservoir includes an inlet port configured to receive the drug fluid from the drug fluid injector and a second port configured to engage with the sealing arrangement.

22. The drug fluid delivery device according to claim 20, wherein, One of the first joint or the second joint has a stronger attachment arrangement structure than the other of the first joint or the second joint, for the purpose of disengaging the connector in stages after filling.

23. The drug fluid delivery device according to claim 20, wherein, The connector provides a fluid passage between the drug fluid injector and the reservoir, and can be discarded once the reservoir has been filled with the drug fluid injector.

24. The drug fluid delivery device according to claim 1, wherein, The dispensing unit includes a housing that accommodates the reservoir and a planar adhesive sheet disposed on one side of the housing, wherein the dispenser extends from the adhesive surface of the adhesive sheet opposite to the housing with one or more needles or microneedles, and wherein the planar adhesive sheet includes removal protrusions that aid in removal from the user's skin.

25. The drug fluid delivery device according to claim 24, wherein, The drive unit and the distribution unit can be releasably attached using a latch arrangement configured to disengage in one direction when the user holds the removal tab.

26. The drug fluid delivery device according to claim 1, wherein, The drive unit can be releasably attached to the distribution unit by means of complementary structures on the drive unit and the distribution unit.

27. The drug fluid delivery device according to claim 1, wherein, The dispensing unit includes a housing with an upright portion in which the reservoir and the plunger are housed. The housing includes rigid ribs for corresponding clearance engagement with the drive unit for precise positioning and movement of the plunger.

Images