Pump mechanism with dual reservoirs and fixed fluid ports

Abstract

Disclosed herein is a dual-reservoir configuration for a pump mechanism for a drug delivery device, in which one reservoir is rigidly fixed to the device housing and the other reservoir moves linearly relative to the fixed reservoir. To avoid movement of either the fluid inlet or outlet ports when the second reservoir moves linearly, one port is in fluid communication with the fixed reservoir, and the second fluid port is in communication with the movable reservoir via a hollow tube that supports a static plunger disposed within the movable reservoir. This configuration provides the additional advantage of allowing air trapped in either of the two reservoirs to be nearly completely removed when the pump mechanism is filled with fluid.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Provisional Patent Application No. 63 / 370,393, filed August 4, 2022, the contents of which are incorporated herein by reference in their entirety. [Background technology]

[0002] Many conventional automatic medication delivery systems are known, including, for example, wearable medication delivery devices. The medication delivery device can be designed to deliver any type of liquid medication to a user. In certain embodiments, the medication delivery device 102 can be, for example, an OmniPod® medication delivery device manufactured by Insulet, Inc. of Acton, Massachusetts. The medication delivery device can be a medication delivery device described in U.S. Pat. No. 7,303,549, U.S. Pat. No. 7,137,964, or U.S. Pat. No. 6,740,059, each of which is incorporated herein by reference in its entirety.

[0003] The medication delivery devices typically include a positive displacement pump mechanism. The pump mechanism may include a reservoir for storing a liquid medication. The liquid medication stored in the reservoir may be delivered to a user by forcing the medication from the reservoir using a drive plunger that translates longitudinally through the reservoir and expelling the liquid medication through a fluid port defined in the reservoir. The plunger may be translated longitudinally through the reservoir, for example, by a rigid lead screw that pushes the plunger forward during pumping.

[0004] In one embodiment, a pump mechanism for use in a drug delivery device uses a dual reservoir configuration, which is shown schematically in FIG. 2 and disclosed in U.S. Provisional Patent Application No. 63 / 304,270, filed January 28, 2022. In this configuration, the pump mechanism has a relatively large outer reservoir 202 and a relatively small inner reservoir 204, with the inner reservoir 204 having a slightly smaller cross-sectional shape than the outer reservoir 202 such that the inner reservoir 204, which acts as a plunger for the outer reservoir 202, can move linearly in and out of the outer reservoir 202. The two reservoirs 202, 204 are in fluid communication with each other via a rigid hollow rod 206 disposed between the inner reservoir 202 and the outer reservoir 204, which rod supports a static plunger 208 against the inner reservoir 204 such that as the inner reservoir 204 moves linearly into the outer reservoir 202, the inner reservoir 204 forces fluid from the outer reservoir 202 into the inner reservoir 204 via the hollow rod 206. The static plunger 208 in the inner reservoir 204 acts to force fluid out of the inner reservoir 204 through a fluid outlet port 210 as the inner reservoir 204 moves linearly into the outer reservoir 202. The inner reservoir 204 and outer reservoir 202 are filled via a fluid inlet port 212.

[0005] In a dual reservoir pump mechanism, one or both reservoirs must move during filling of the pump mechanism or delivery of a fluid medication. In the exemplary configuration shown in FIG. 2, the outer reservoir 202 is stationary (fixed) and rigidly connected to the housing of the medication delivery device at attachment point 214, and the inner reservoir 204 moves relative to the outer reservoir 202. Other configurations are possible. Because it is desirable to allow air to escape from both reservoirs of the pump mechanism during the filling process, one port must be fluidly connected to one reservoir and the other port must be fluidly connected to the other reservoir. For example, in one embodiment, the fill port can be fluidly connected to the outer reservoir and the delivery port can be fluidly connected to the inner reservoir.

[0006] Fluid transfer becomes more difficult when one of the two reservoirs is moving, as reservoir movement poses various risks to the fluid pathway connected to this movable reservoir: leaks in the fluid pathway, air trapped in the fluid pathway, unintended dosing, and increased dead volume are some of the risks.

[0007] Finding a solution to avoid the above risks would significantly improve the performance and reliability of dual reservoir pump systems. Therefore, it is desirable to provide a design for a dual reservoir configuration that allows for a fixed fluid port to be fluidly connected to a movable reservoir. [Prior art documents] [Patent documents]

[0008] [Patent Document 1] U.S. Patent No. 7,303,549 [Patent Document 2] U.S. Patent No. 7,137,964 [Patent Document 3] U.S. Patent No. 6,740,059 Summary of the Invention

[0009] This Summary is provided to introduce a selection of concepts in a simplified form that are further described below in the Detailed Description. This Summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended as an aid in determining the scope of the claimed subject matter.

[0010] In a primary embodiment of the present invention, a design is presented that provides a fixed fluid port in fluid communication with the movable reservoirs in a dual reservoir pump mechanism. This design extends a fluid path connected to a needle or cannula via a plunger tube 206 from the back of the outer reservoir 202 to the inner reservoir 204, providing a path for removing air from the inner reservoir 204 while the fluid supply port and fluid path to the needle or cannula remain stationary, even as the inner reservoir 204 moves. This design is described in detail below.

[0011] In the drawings, as used herein, like reference numerals generally refer to the same parts throughout the different views.In the following description, various embodiments of the present invention are described with reference to the following drawings: [Brief explanation of the drawings]

[0012] [Figure 1] FIG. 1 illustrates a functional block diagram of an exemplary system suitable for implementing the systems and methods disclosed herein. [Figure 2] FIG. 2 is a schematic diagram of one embodiment of a dual reservoir (pump mechanism). [Figure 3] FIG. 3 is a cross-sectional perspective view of the novel pump mechanism of the main embodiment disclosed herein. [Figure 4] Figure 4(a) is a perspective view of the embodiment of Figure 3 showing the pump mechanism in a filled configuration, and Figure 4(b) is a cross-sectional view of the pump mechanism in a filled configuration. [Figure 5] Figure 5(a) is a perspective view of the embodiment of Figure 3 showing the pump mechanism in an empty configuration, and Figure 5(b) is a cross-sectional view of the pump mechanism in an empty configuration. [Figure 6] FIG. 6 is a see-through view of a portion of the outer reservoir of the embodiment of FIG. 3, showing the connection between the inlet port and the interior of the outer reservoir. DETAILED DESCRIPTION OF THE INVENTION

[0013] The present invention provides various systems, components, and methods for transferring a liquid medication from a liquid reservoir in a medication delivery device to a patient interface, such as a needle or cannula. The embodiments described herein offer one or more advantages over conventional prior art systems, components, and methods, namely, an overall smaller packaging area for the medication delivery device.

[0014] Various embodiments of the present disclosure include systems and methods for delivering medication to a user using a medication delivery device (sometimes referred to herein as a "pod"), either autonomously or according to wireless signals received from an electronic device. In various aspects, the electronic device may be a smartphone, a smart watch, a smart necklace, a user device with a module attached to the medication delivery device, or any other type or kind of electronic device that can be carried by or worn on the user's body and that executes an algorithm to calculate the number and dosage of medication deliveries.

[0015] For example, the user device may run an "artificial-pancreas" (AP) algorithm that calculates the frequency and dosage of insulin deliveries. The user device may also communicate with a sensor, such as a glucose sensor or continuous glucose monitor (CGM), that collects information about the user's physical characteristics or condition, such as glucose levels. The sensor may be located in or on the user's body and may be part of the drug delivery device or may be a separate device.

[0016] Alternatively, the medication delivery device may communicate with the sensor instead of or in addition to communication between the sensor and the user device. This communication may be direct (e.g., if the sensor is integrated with or otherwise part of the medication delivery device) or remote / wireless (e.g., if the sensor is located in a housing separate from the medication delivery device). In these embodiments, the medication delivery device includes computer hardware (e.g., processor, memory, firmware, etc.) that executes some or all of the algorithms that calculate the time (frequency) and dosage of medication delivery.

[0017] 1 shows a functional block diagram of an exemplary drug delivery system 100 suitable for implementing the systems and methods described herein. The drug delivery system 100 can implement drug delivery algorithms (and / or provide functionality), such as for artificial pancreas (AP) applications, to manage or control the automated delivery of a drug or medication, such as insulin, to a user (e.g., to maintain normal blood glucose levels in the blood). The drug delivery system 100 can be an automated drug delivery system that can include a drug delivery device 102 (which can be wearable), an analyte sensor 108 (which can be wearable), and a user device 105. Types of drugs that can be delivered by the drug delivery device include, for example, insulin, GLP-1, pramlintide, glucagon, morphine, blood pressure medications, chemotherapy medications, fertility medications, arthritis medications, etc., or co-formulations of two or more of GLP-1, pramlintide, and insulin.

[0018] The drug delivery system 100 may also include, in any example, an accessory device 106, such as a smart watch, personal assistant device, insulin smart pen, etc., that can communicate with other components of the system 100 via either wired or wireless communication links 191-193.

[0019] User Device The user device 105 may be a computing device such as a smartphone, a smartwatch, a tablet, a personal diabetes management (PDM) device, a dedicated diabetes care management device, etc. For example, the user device 105 may have a processor 151, a device memory 153, a user interface 158, and a communication interface 154. The user device 105 may also include analog and / or digital circuitry that may be implemented as the processor 151 to perform processing based on program code stored in the device memory 153, such as a user application 160 incorporating a drug delivery algorithm (MDA) 161 for managing the user's blood glucose levels, and / or to control the delivery of medications, drugs, or therapeutic agents to the user, and / or to provide other functions such as calculating carbohydrate compensation doses, correction bolus doses, etc., as described below. The user device 105 may be used to activate, deactivate, trigger, needle / cannulate, program, adjust settings, and / or control operations of the drug delivery device 102 and / or analyte sensor 103 and any optional smart accessory devices 106.

[0020] The processor 151 may also be configured to execute programming code stored in the device memory 153, such as a user application 160. The user application 160 may be a computer application operable to deliver medication based on data received from the analyte sensor 103, the cloud-based service 111, and / or the user device 105 or any selected accessory device 106. The memory 153 may also store programming code for operating a user interface 158 (e.g., a touchscreen device, a camera, etc.), a communication interface 154, etc. When executing the user application 160, the processor 151 may be configured to implement metrics and notifications regarding meal intake, blood glucose measurements, etc. The user interface 158 is under the control of the processor 151 and may be configured to present a graphical user interface, such as to allow for input of meal announcements, adjusting setting selections, etc., as described herein.

[0021] In a specific example, when the user application 160 includes the MDA 161, the processor 151 is also configured to execute a diabetes treatment plan (which may be stored in memory) managed by the user application 160. In addition to the functions described above, when the user application 160 is for artificial pancreas (AP) use, it may further provide functionality for determining carbohydrate compensation doses, correction bolus doses, and determining real-time basal doses according to the diabetes treatment plan. Furthermore, the user application 160 provides the functionality for outputting signals to the drug delivery device 102 via the communication interface 154 to deliver the determined bolus and / or basal doses.

[0022] Communications interface 154 includes one or more transceivers that operate according to one or more radio frequency protocols. In one embodiment, the transceivers may include a cellular transceiver and a Bluetooth transceiver. Communications interface 154 may be configured to receive and transmit signals containing information usable by user application 160.

[0023] The user device 105 may further include one or more output devices 155, which may be, for example, speakers or vibration transducers, for providing various signals to the user.

[0024] Drug supply device In various exemplary embodiments, the medication delivery device 102 can have a reservoir 124 and a drive mechanism 125 controllable by a controller 121, which can execute a medication delivery algorithm (MDA) 129 stored in memory 123 and perform some or all of the functions of the AP application described above, such that the user device 105 may not need the medication delivery and control performed by the medication delivery device 102. Alternatively, the controller 121 can act to control the reservoir 124 and the drive mechanism 125 based on signals received from a user application 160 executing on the user device 105 and communicated to the medication delivery device 102 via a communication link 194. The drive mechanism 125 can operate, for example, to translate a plunger longitudinally through the reservoir to force liquid medication through a fluid exit port and into the needle / cannula 186.

[0025] In alternative embodiments, the medication delivery device 102 may also have an optional second reservoir 124-2 and second drive mechanism 125-2, allowing for independent delivery of two different liquid medications. For example, the reservoir 124 may be filled with insulin, and the reservoir 124-2 may be filled with pramlintide, GLP-1, glucagon, or another medication. In some embodiments, each of the reservoirs 124, 124-2 may be configured with a separate drive mechanism 125, 125-2, respectively, which may be independently controllable by the controller 121 under the control of the MDA 129. Both reservoirs 124, 124-2 may be connected to a common needle / cannula 186.

[0026] The medication delivery device 102 may optionally be configured with a user interface 127 that provides means for receiving input from and output to a user. The user interface 127 may comprise, for example, a light emitting diode, a button on the housing of the medication delivery device 102, an acoustic transducer, a microdisplay, a microphone, an accelerometer for detecting device movement or a user gesture (e.g., tapping on the housing of the device), or any other type of interface device configured to allow a user to input information and / or enable the medication delivery device 102 to emit information for presentation to a user (e.g., an alarm signal, etc.).

[0027] The drug delivery device 102 has a patient interface 186 for mating with a user to deliver the liquid drug. The patient interface may be, for example, a needle, cannula, or microneedle array for delivering the drug into the user's body (which may be subcutaneous, intraperitoneal, or intravenous). The drug delivery device 102 further has a mechanism for inserting the needle / cannula 186 into the user's body, which may be integral to the drug delivery device 102 or may be attachable thereto. The insertion mechanism, in one embodiment, may comprise an actuator that inserts the needle / cannula 186 beneath the user's skin and then retracts the needle, leaving the cannula in place. The actuator may be triggered by the user device 105 or may be a manually fired mechanism that includes a spring or other energy storage mechanism that causes the needle / cannula 186 to penetrate the user's skin.

[0028] In one embodiment, the medication delivery device 102 has a communication interface 126, which may be a transceiver operating according to one or more radio frequency protocols such as Bluetooth, Wi-Fi, near field communication, cellular, etc. The controller 121 may communicate with the user device 105 and the analyte sensor 108, for example, via the communication interface 126.

[0029] In some embodiments, the drug delivery device 102 can include one or more sensors 184. The sensors 184 include one or more pressure sensors, power sensors, etc., communicatively coupled to the controller 121 and providing various signals. For example, the pressure sensor can be configured to provide an indication of fluid pressure detected in the fluid path between the patient interface 186 and the reservoir 124. The pressure sensor can be coupled to or integrated with an actuator for inserting the patient interface 186 into the user. In one example, the controller 121 can be operable to determine a rate of drug infusion based on the indication of fluid pressure. The rate of drug infusion can be compared to an infusion rate threshold, and the result of this comparison can be used in determining an insulin payload (IOB) or total daily insulin (TDI) amount. In one embodiment, the analyte sensor 108 can be integrated with the drug delivery device 102.

[0030] The drug delivery device 102 further comprises a power source 128, such as a battery, a piezoelectric device, an energy harvesting device, or the like, for powering the control unit 121, the memory 123, the drive mechanism 125, and / or other components of the drug delivery device 102.

[0031] The medication delivery device 102 may be configured to implement and perform the processes required to deliver multiple doses of medication to a user without input from the user device 105 or optional accessory device 106. As will be described in more detail, the MDA 129 may be operable to determine, for example, the amount of insulin to be delivered, IOB, remaining insulin, etc., and to cause the controller 121 to actuate the drive mechanism 125 to deliver medication from the reservoir 124. The MDA 129 may obtain input data received from the analyte sensor 108 or a user application 160.

[0032] Reservoirs 124, 124-2 may be configured to store a medication, drug or therapeutic agent suitable for automated delivery, such as insulin, pramlintide, GLP-1, a co-formulation of insulin and GLP-1, glucagon, morphine, blood pressure medication, chemotherapy medication, reproductive function medication, arthritis medication, or the like.

[0033] The drug delivery device 102 may be a wearable device that can be attached to the body of a user, such as a patient or diabetic, at an attachment location and can deliver any therapeutic agent, including any drug or medication, to the user at or around the attachment location. The surface of the drug delivery device 102 may have an adhesive to facilitate attachment to the user's skin.

[0034] When the drug delivery device 102 is configured to communicate with an external device, such as a user device 105 or an analyte sensor 108, the drug delivery device 102 can receive signals from the user device 105 or the analyte sensor 108 via a wired or wireless link 194. A controller 121 of the drug delivery device 102 can receive and process the signals from the respective external device and effectuate delivery of drugs to the user in accordance with a diabetes treatment plan or other drug delivery regimen.

[0035] Accessory Devices The optional accessory device 107 may be a wearable smart device, such as a smart watch (e.g., an Apple Watch®), smart glasses, smart jewelry, a global positioning system (GPS)-enabled wearable device, a wearable fitness device, smart clothing, etc. Similar to the user device 105, the accessory device 107 may also be configured to perform various functions, including controlling the medication delivery device 102. For example, the accessory device 107 may include a communications interface 174, a processor 171, a user interface 178, and memory 173. The user interface 178 may be a graphical user interface presented on a touchscreen display of the smart accessory device 107. The memory 173 may store programming code for operating various functions of the smart accessory device 107, as well as an instance of a user application 160 or a simplified version of the user application 160 with reduced functionality. In some examples, the accessory device 107 may also include various types of sensors.

[0036] Analyte Sensor The analyte sensor 108 may have a controller 131, a memory 132, a detection / measurement device 133, an optional user interface 137, a power / energy harvesting circuit 134, and a communication interface 135. The analyte sensor 108 may be communicatively coupled to a processor 151 of the management device 105 or controller 121 of the medication delivery device 102. The memory 132 may be configured to store information and programming code 136.

[0037] The analyte sensor 108 may be configured to detect one or more different analytes, such as glucose, lactate, ketone, uric acid, sodium, potassium, or alcohol level, and output a detection result, such as a measurement. In an exemplary embodiment, the analyte sensor 108 may be configured as a continuous glucose monitor (CGM) for measuring blood glucose levels at predetermined time intervals, such as every five minutes or every minute. The communication interface 135 of the analyte sensor 108 may include circuitry operating as a transceiver to communicate the measured blood glucose level to the user device 105 via wireless link 195 or to the medication delivery device 102 via wireless communication link 108. Although referred to herein as the analyte sensor 108, the detection / measurement unit 133 of the analyte sensor 108 may include one or more additional sensing elements, such as a glucose measuring element, a heart rate monitor, or a pressure sensor. The controller 131 may include separate dedicated logic and / or components, an application specific integrated circuit, a microcontroller or processor that executes software instructions, firmware, programming instructions stored in a memory (such as memory 132), or any combination thereof.

[0038] Similar to the controller 121 of the medication delivery device 102, the controller 131 of the analyte sensor 108 may be operable to perform many functions. For example, the controller 131 may be configured by programming code 136 to manage the collection and analysis of data detected by the detection and measurement device 133.

[0039] 1 as being separate from the drug delivery device 102, in various aspects the analyte sensor 108 and the drug delivery device 102 may be incorporated into the same unit. That is, in various embodiments the analyte sensor 108 may be part of and integrated with the drug delivery device 102, and may be included in the same housing as or in a housing attachable to the drug delivery device 102. In such an exemplary configuration, the controller 121 may perform the functions required for proper delivery of the drug alone, without any external input from the user device 105, the cloud-based service 111, another sensor (not shown), optional accessory device 106, etc.

[0040] Cloud-based services The medication delivery system 100 can communicate with or receive services from a cloud server 122 that provides a cloud-based service 111. The services provided by the cloud server 112 can have a data memory that stores personalized or anonymized data, such as blood glucose measurements, past IOB or TDI, prior carbohydrate compensation doses, and other forms of data. Additionally, the cloud-based service 111 can process anonymized information from multiple users to provide generalized information related to TDI, insulin sensitivity, IOB, etc. The communication link 115 coupling the cloud server 112 to other components of the system 100, such as the devices 102, 105, 106, and 108 of the system 100, can be a cellular link, a Wi-Fi link, a Bluetooth link, or a combination thereof.

[0041] communication links Wireless communication links 115 and 191-196 may be any type of wireless link operating using a known wireless communication standard or a proprietary standard. By way of example, wireless communication links 191-196 may provide a communication link based on Bluetooth, Zigbee, Wi-Fi, a near field communication standard, a cellular standard, or any other wireless protocol via respective communication interfaces 126, 135, 154, and 174.

[0042] Example of operation In an operational example, the user application 160 implements a graphical user interface that is the primary interface with the user, used to start and stop the medication delivery device 102, program basal and bolus calculator settings for manual mode, and program settings specific to automatic mode (hybrid closed-loop or closed-loop).

[0043] The user application 160 provides a graphical user interface 158 that allows the use of large text, graphics, and on-screen instructions to prompt the user through the setup process and use of the system 100. It is also used to program the user's custom basal insulin delivery profile, check the status of the medication delivery device 102, initiate an insulin bolus, change the patient's insulin delivery profile, handle system alerts and alarms, and allow the user to switch between automatic and manual modes.

[0044] The user application 160 can be configured to operate in a manual mode in which the user application 160 delivers insulin at a programmed basal rate and a user-defined bolus amount, with the option to set a temporary basal profile. The controller 121 also has the capability to function as a sensor-enhanced pump in manual mode, using sensor glucose data provided by the analyte sensor 108 to feed into a bolus calculator.

[0045] The user application 160 can be configured to operate in an automatic mode that supports the use of multiple target blood glucose levels. For example, in one embodiment, the target blood glucose levels can be in the range of 110 mg / dL to 150 mg / dL, in 10 mg / dL increments, 5 mg / dL increments, or other increments, preferably 10 mg / dL increments. The user experience mirrors the current setup flow, whereby a healthcare provider assists the user in programming the basal rate, glucose target, and bolus calculator setup. These inform the user application 160 of insulin dosing parameters. The insulin dosing parameters are adapted over time based on the total daily insulin (TDI) delivered during each use of the medication delivery device 102. A hypoglycemic protection mode can be implemented by the user for various durations in the automatic mode. In hypoglycemic protection mode, the algorithm reduces insulin delivery and is intended for use for hypoglycemic durations when insulin sensitivity is expected to be higher (e.g., during exercise).

[0046] The user application 160 (or MDA 129) may provide periodic insulin microboluses based on past glucose measurements and / or predicted glucose over a predicted period (e.g., 60 minutes). Optimal post-meal control may require the user to deliver meal boluses in the same manner as current pump therapy, but the normal operation of the user application 160 compensates for missed meal boluses and reduces prolonged hyperglycemia. The user application 160 uses a control-to-target strategy that attempts to achieve and maintain set target blood glucose levels, thereby reducing the duration of prolonged hyperglycemia and hypoglycemia.

[0047] In some embodiments, the user device 105 and the analyte sensor 108 may not communicate directly with each other. Instead, data from the analyte sensor (e.g., blood glucose level) may be transmitted to the medication delivery device 102 via link 196 and then relayed to the user device 105 via link 194. In some embodiments, the serial number of the analyte sensor must be entered into the user application 160 to enable communication between the analyte sensor 108 and the user device 105.

[0048] The user application 160 may provide the ability to calculate a suggested bolus dose through the use of a bolus calculator. The bolus calculator is provided as a user convenience to help determine a suggested bolus dose based on ingested carbohydrates, the most recent blood glucose reading (or blood glucose reading if using a fingertip), a programmable correction factor, an insulin to carbohydrate ratio, a target blood glucose level, and on-board insulin (IOB). The user application 160 estimates the IOB, taking into account the manual bolus and insulin.

[0049] Description of the embodiment 3 shows an exemplary embodiment of the present invention that eliminates having either an inlet or outlet port on the movable reservoir in a dual reservoir pump mechanism. In the embodiment shown in FIG. 3, the outer reservoir 202 is a fixed reservoir and the inner reservoir 204 is a movable reservoir that moves linearly back and forth within the outer reservoir 202.

[0050] During the filling process, it is necessary to ensure that all (or nearly all) trapped air in both the outer reservoir 202 and the inner reservoir 204 can be removed from the pump mechanism. To properly remove air from the pump mechanism during the filling process, it is necessary to have the fill port and supply port on different reservoirs, one of which will necessarily be moving. As shown in FIG. 2, fluid enters the pump mechanism through the fill port 212 and pushes air trapped in the outer reservoir 202 through the plunger tube 206 and into the inner reservoir 204. Air trapped in the inner reservoir 204 exits the system through the supply port 210. However, as previously mentioned, it is preferable not to have either the fill port or the supply port on a moving reservoir.

[0051] The embodiment of Figure 3 solves this problem by adding an additional fluid path 302 located within the plunger tube 206 in fluid communication with the supply port 304 such that the supply port 304 is repositioned to the fixed reservoir 202 (the outer reservoir in this example). The black arrows in Figure 3 indicate the flow of fluid (or initially air) from the fill port 212 to the supply port 304 during the filling process. Without the additional fluid path 302 connecting the supply port 304 to the inner reservoir 204, air would remain trapped within the inner reservoir 204 after the filling process was complete, reducing the amount of fluid (e.g., liquid medication) that can be retained within the pump mechanism.

[0052] During the filling process, fluid enters the fill port 212 and travels through the plunger tube 206, where it begins to fill both the inner reservoir 204 and the outer reservoir 202 as the reservoirs separate. That is, the inner reservoir 202 is forced to slide in direction "A" by the hydraulic action of the fluid entering the outer reservoir 202. Any air remaining in the outer reservoir 202 travels through the push rod 206 and into the inner reservoir 204, while any air remaining in the inner reservoir 204 is forced through the fluid path 302 and out of the system via the supply port 304. The additional fluid path 302 and supply port 304 are initially filled with fluid. A hydrophobic vent can be located at the distal end of the exhaust port 304, and when this vent becomes wet with fluid, the supply port 304 is blocked due to the fact that the hydrophobic vent does not allow fluid to pass through once wetted. At this point, air has been forced out of the further fluid path 206 and the supply port 304. As fluid continues to be forced into the fill port 212, pressure increases, causing the inner reservoir 204, on whose end the plunger 214 is located, to move in direction "A." Both the inner reservoir 202 and the outer reservoir 304 simultaneously fill with fluid. Once both reservoirs are filled, there is little or no air remaining in the pump mechanism.

[0053] Figure 4(a) shows an exemplary embodiment of a dual reservoir pump mechanism in a filled configuration, and Figure 4(b) shows a cross-sectional view of the pump mechanism in a filled configuration. Figure 5(a) shows the pump mechanism in an empty configuration, and Figure 5(b) shows a cross-sectional view of the pump mechanism in an empty configuration. As shown, both the fill port 212 and the supply port 304 are located on the outer reservoir 202 and are sealed with pierceable septa 402 and 404, respectively. This cross-sectional view illustrates how an additional fluid path 302 can be used to extend the exhaust port 304 from the back of the outer reservoir 202 through the plunger tube 206 to the inner reservoir 204, thereby making it possible to have both the fill port 212 and the supply port 304 fixed relative to the outer reservoir 202, even when the inner reservoir 202 moves. One end of the further fluid pathway 302 is disposed at the end of the plunger tube 206 to allow fluid to pass through the outer reservoir 202 and the plunger tube 206 before exiting the reservoir, thereby facilitating the removal of air from the dual reservoir pump mechanism. The other end of the supply port 304 is secured to an insertion mechanism (not shown) and provides a fluid pathway from the drug delivery device to the patient's body.

[0054] FIG. 6 is a see-through view of a portion of the outer reservoir 202 showing a fluid path 602 from the fill port 212 to the interior of the outer reservoir 202, according to an exemplary embodiment.

[0055] As will be appreciated by those skilled in the art, exemplary embodiments are presented herein using a specific dual-reservoir configuration in which the outer reservoir 202 is fixed relative to the housing of the drug delivery device 100, and the inner reservoir 204 moves out of the outer reservoir 202 during the filling process and moves into the outer reservoir 202 during fluid delivery. The fill port 212 and the supply port 304 extend through the end wall 306 of the outer reservoir 202 and remain stationary during movement of the inner reservoir. In other embodiments, the fill port 212 and the supply port 304 are interchangeable, and this concept can be used for both fluid ports. Thus, the scope of the present invention is meant to include embodiments in which the inner reservoir is rigidly fixed relative to the housing of the drug delivery device 100, and movement of the outer reservoir causes the inner reservoir to nest within the outer reservoir. In this case, the fill port 212 is in fluid communication with the inner reservoir 204, while the supply port 304 is in fluid communication with the outer reservoir 202 via an additional fluid path 302 extending through the hollow tube 206. In this embodiment, the fill port 212 and the supply port 304 extend through the end wall of the inner reservoir 204 so as to remain stationary during movement of the outer reservoir. Other embodiments of pump mechanisms having movable reservoirs not specifically discussed herein are also contemplated to be within the scope of the present invention. The present invention is not meant to be limited by the exemplary dual reservoir pump mechanism used to describe the invention herein.

[0056] The following examples relate to various embodiments of the systems and methods disclosed herein for the implementation of an automated drug delivery system having a dual reservoir pump mechanism.

[0057] Example 1 is a first embodiment of a pump mechanism, the pump mechanism comprising: an outer reservoir; an inner reservoir configured for linear movement within the outer reservoir; a static plunger disposed within the inner reservoir; a hollow tube supporting the static plunger and extending between the inner reservoir and the outer reservoir, thereby fluidly connecting the inner reservoir to the outer reservoir; a first fluid port in fluid communication with the outer reservoir; and a second fluid port in fluid communication with the inner reservoir, wherein one of the first fluid port or the second fluid port extends through the hollow tube.

[0058] Example 2 is a scope of Example 1, or any other example disclosed herein, in which the external reservoir is rigidly attached to a structure external to the pump mechanism.

[0059] Example 3 is within the scope of Example 2, or any other example disclosed herein, where the second fluid port extends through the hollow tube, the second fluid port extends from the end wall of the outer reservoir, and the first fluid port and the second fluid port remain stationary as the inner reservoir moves in and out of the outer reservoir.

[0060] Example 4 is a scope of Example 1, or any other example disclosed herein, in which the internal reservoir is rigidly attached to a structure external to the pump mechanism.

[0061] Example 5 is within the scope of Example 4, or any other example disclosed herein, where the first fluid port extends through the hollow tube, the first fluid port extends from an end wall of the inner reservoir, and the first fluid port and the second fluid port remain stationary when the other reservoir moves relative to the inner reservoir.

[0062] Example 6 is a scope of Example 1, or any other example disclosed herein, in which the inner and outer reservoirs move apart as the pump mechanism fills with fluid.

[0063] Example 7 is within the scope of Example 1 or any other example disclosed herein, wherein the pump mechanism further includes a drive mechanism for moving the inner reservoir and the outer reservoir toward each other when fluid is supplied within the pump mechanism.

[0064] Example 8 is within the scope of example 1 or any other example disclosed herein, wherein the pump mechanism further comprises a fluid seal between the inner surface of the outer reservoir and the outer surface of the inner reservoir.

[0065] Example 9 is within the scope of Example 1 or any other example disclosed herein, wherein the pump mechanism further includes a fluid seal disposed on a circumferential surface of the static plunger to create a fluid seal between the static plunger and an inner surface of the inner reservoir.

[0066] Example 10 is within the scope of example 1 or any other example disclosed herein, wherein the pump mechanism further comprises a fluid seal between the hollow tube and an end wall of the inner reservoir.

[0067] Example 11 is the scope of Example 10 or any other example disclosed herein, wherein the inner reservoir and the outer reservoir have a cross-sectional shape selected from the group consisting of an oval, a flattened circle, and a rectangle with rounded corners.

[0068] Example 12 is within the scope of Example 10, or any other example disclosed herein, wherein the hollow tube extends through an end wall of the inner reservoir to enable fluid communication between the inner reservoir and the outer reservoir.

[0069] Example 13 is a second embodiment of a pump mechanism, the pump mechanism comprising: an outer reservoir attached to a structure external to the pump mechanism; an inner reservoir configured to move linearly in and out of the outer reservoir; a static plunger disposed inside the inner reservoir; a hollow tube supporting the static plunger and extending between the inner and outer reservoirs, thereby fluidly connecting the inner reservoir to the other reservoir; and a first fluid port communicating with the outer reservoir and extending through the hollow tube, the second fluid port extending through an end wall of the outer reservoir such that the first and second fluid ports remain stationary as the inner reservoir moves in and out of the outer reservoir.

[0070] Example 14 is a third embodiment of a pump mechanism, the pump mechanism comprising: an inner reservoir attached to a structure external to the pump mechanism; an outer reservoir configured for linear movement such that the inner reservoir is nested within the outer reservoir; a static plunger disposed within the inner reservoir; a hollow tube supporting the static plunger and extending between the inner and outer reservoirs; a first fluid port fluidly connecting the inner reservoir to the outer reservoir and in fluid communication with the inner reservoir; and a second fluid port fluidly communicating with the outer reservoir and extending through the hollow tube, wherein the first fluid port extends through an end wall of the outer reservoir such that the first fluid port and the second fluid port remain stationary as the outer reservoir moves toward the inner reservoir.

[0071] Software-related implementations of the techniques described herein may include, but are not limited to, firmware, application-specific software, or any other type of computer-readable instructions that may be executed by one or more processors. The computer-readable instructions may be provided via a non-transitory computer-readable medium. Hardware-related implementations of the techniques described herein include, but are not limited to, integrated circuits (ICs), application-specific ICs (ASICs), field programmable arrays (FPGAs), and / or programmable logic devices (PLDs). In some examples, the techniques described herein and / or any systems or components described herein may be implemented using a processor executing computer-readable instructions stored on one or more memory components.

[0072] Those skilled in the art to which the present invention pertains will recognize many modifications and adaptations of the present invention. The embodiments provided herein, including the dimensions, shapes, ratings, and specifications of the various components or component arrangements, as well as descriptions of specific manufacturing processes, are illustrative only and are not intended to limit the present invention in any way. As those skilled in the art will appreciate, many variations of the configurations discussed herein are possible that fall within the scope of the present invention. Furthermore, it should be understood that the features of the various aspects described herein are not mutually exclusive and can exist in various combinations and permutations without departing from the spirit and scope of the present invention, even if such combinations or permutations are not expressly stated herein. Accordingly, the methods and apparatus disclosed herein should be construed as illustrative, not limiting, of the present invention. The scope of the present invention is defined by the following claims.

Claims

1. In the pump mechanism, The pump mechanism includes: an outer reservoir; and an inner reservoir configured to be positionable within the outer reservoir; A static plunger; a hollow tube supporting the static plunger and extending between the inner reservoir and the outer reservoir, thereby fluidly connecting the inner reservoir to the outer reservoir; a first fluid port in fluid communication with the external reservoir; a second fluid port in fluid communication with the internal reservoir; A pump mechanism, wherein one of the first fluid port or the second fluid port extends through a hollow tube.

2. The pump mechanism of claim 1 , wherein the external reservoir is rigidly attached to a structure external to the pump mechanism.

3. the second fluid port extends through the hollow tube; the second fluid port extends through an end wall of the outer reservoir; 3. The pump mechanism of claim 2, wherein the first fluid port and the second fluid port remain stationary as the inner reservoir moves in and out of the outer reservoir.

4. The pump mechanism of claim 1 , wherein the internal reservoir is rigidly attached to a structure external to the pump mechanism.

5. the first fluid port extends through a hollow tube, the first fluid port extends through an end wall of an inner reservoir; 5. The pump mechanism of claim 4, wherein the first fluid port and the second fluid port remain stationary as the other reservoir moves to nest the inner reservoir.

6. 2. The pump mechanism of claim 1, wherein the inner and outer reservoirs move apart as the pump mechanism fills with fluid.

7. The pump mechanism includes:

2. The pump mechanism of claim 1, further comprising a drive mechanism for moving the inner and outer reservoirs toward each other when fluid within the pump mechanism is pumped.

8. The pump mechanism includes: The pump mechanism of claim 1 , further comprising a fluid seal between an inner surface of the outer reservoir and an outer surface of the inner reservoir.

9. The pump mechanism includes: The pump mechanism of claim 1 , further comprising a fluid seal disposed on a circumferential surface of the static plunger to create a fluid seal between the static plunger and an inner surface of the inner reservoir.

10. The pump mechanism of claim 8 , further comprising a fluid seal between the hollow tube and an end wall of the inner reservoir.

11. 10. The pump mechanism of claim 1, wherein the inner and outer reservoirs have cross-sectional shapes selected from the group consisting of oval, flattened circle, and rectangle with rounded corners.

12. The pump mechanism of claim 1 , wherein the hollow tube extends through an end wall of the inner reservoir to allow fluid communication between the inner reservoir and the outer reservoir.

13. In a drug delivery device, The drug delivery device comprises: A pump mechanism, the pump mechanism comprising: an outer reservoir; and an inner reservoir configured to be positionable within the outer reservoir; A static plunger; a hollow tube supporting the static plunger and extending between the inner reservoir and the outer reservoir, thereby fluidly connecting the inner reservoir to the outer reservoir; a first fluid port in fluid communication with the external reservoir; a second fluid port in fluid communication with the internal reservoir; one of the first fluid port or the second fluid port extends through the hollow tube; A medication delivery device comprising a pump mechanism and a controller for controlling operation of the pump mechanism.

14. the second fluid port extends through the hollow tube; the second fluid port extends through an end wall of the outer reservoir; 14. The medication delivery device of claim 13, wherein the first fluid port and the second fluid port remain stationary as the inner reservoir moves in and out of the outer reservoir.

15. The drug delivery device comprises:

14. The medication delivery device of claim 13, further comprising a drive mechanism for moving the inner and outer reservoirs toward each other when fluid in the pump mechanism is pumped.

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