Pump mechanism with dual reservoir and stationary fluid port

Abstract

Disclosed herein is a dual reservoir configuration for a pumping mechanism of a drug delivery device in which one reservoir is rigidly secured to a housing of the device and the other reservoir linearly translates relative to the stationary reservoir. To avoid movement of the input fluid port or the output fluid port with linear translation of the second reservoir, one port is in fluid communication with the stationary reservoir, while the second fluid port is in communication with the mobile reservoir via a hollow tube supporting a stationary plunger disposed within the mobile reservoir. The arrangement also provides the benefit of almost completely removing air trapped within any of the reservoirs when the pump mechanism is filled with fluid.

Description

Related Applications

[0001] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 370,393, filed on August 4, 2022, the contents of which are incorporated herein in their entirety. Background Art

[0002] As is well known, many conventional automatic drug delivery systems include, for example, wearable drug delivery devices. The drug delivery device can be designed to deliver any type of liquid drug to a user. In a specific embodiment, the drug delivery device can be, for example, an Omnipod® drug delivery device manufactured by Silver Hutt, Inc. of Acton, Massachusetts. The drug delivery device can be, for example, those described in U.S. Patent No. 7,303,549, U.S. Patent No. 7,137,964, or U.S. Patent No. 6,740,059, the contents of which are incorporated herein as a whole.

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

[0004] One embodiment of a pump mechanism for use in a drug delivery device uses a dual reservoir configuration. Figure 2 63 / 304,270 filed on January 28, 2022. In this configuration, the pump mechanism has a larger outer reservoir 202 and a smaller inner reservoir 204, wherein the inner reservoir 204 has a cross-sectional shape slightly smaller than the outer reservoir 202, so that the inner reservoir 204 can be linearly translated into and out of the outer reservoir 202 as a plunger for the outer reservoir 202. The two reservoirs 202, 204 are in fluid communication with each other by a rigid hollow rod 206, which is disposed between the inner reservoir 202 and the outer reservoir 204 and supports a stationary plunger 208 for the inner reservoir 204, so that when the inner reservoir 204 is linearly translated into the outer reservoir 202, the inner reservoir 204 forces fluid from the outer reservoir 202 through the hollow rod 206 into the inner reservoir 204. As the inner reservoir 204 translates linearly into the outer reservoir 202, a stationary plunger 208 in the inner reservoir 204 is used to force fluid from the inner reservoir 204 through the outlet fluid port 210. The inner reservoir 204 and the outer reservoir 202 are filled through the fluid inlet port 212.

[0005] In a dual-reservoir pump mechanism, one or both reservoirs need to be moved during the filling process of the pump mechanism or during the dispensing process of the liquid medication. Figure 2 In the exemplary configuration shown, the external reservoir 202 is stationary and rigidly connected to the housing of the drug delivery device at the attachment point 214, and the internal reservoir 204 moves relative to the external reservoir 202. Other configurations are also possible. Because it is necessary to allow air to escape from both reservoirs of the pump mechanism during the filling process, it is necessary to have one port fluidly coupled to one reservoir and the other port fluidly coupled to the other reservoir. For example, in one embodiment, the filling port can be fluidly coupled to the external reservoir and the dispensing port can be fluidly coupled to the internal reservoir.

[0006] Fluid delivery is more challenging when one of the reservoirs is moving because the movement of the reservoir imposes various risks on the fluid path connected to the moving reservoir. Leaks in the fluid path, air entrapment in the fluid path, inadvertent dosing, and residual volume buildup are some of these risks.

[0007] Finding a solution that avoids the identified risks would significantly improve performance and increase the reliability of dual-reservoir pumping systems.Therefore, it would be desirable to provide a design for a dual-reservoir configuration that fluidly couples a stationary fluid port to a mobile reservoir. Summary of the invention

[0008] The Summary is provided to introduce some concepts in a simplified form that are further described below in the Detailed Description. The Summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to aid in determining the scope of the claimed subject matter.

[0009] In the main embodiment of the present invention, a design is proposed that provides a fixed fluid port that is in fluid communication with the mobile reservoir in the dual-reservoir pumping mechanism. The design extends the fluid path connected to the needle or cannula from the rear of the external reservoir 202 through the plunger tube 206 to the internal reservoir 204 to provide a path for removing air from the internal reservoir 204, while the dispensing fluid port and the fluid path leading to the needle or cannula are fixed, even when the internal reservoir 204 moves. This design will be described in detail below. BRIEF DESCRIPTION OF THE DRAWINGS

[0010] In the accompanying drawings, the same reference numerals generally refer to the same parts in different views. In the following description, various embodiments of the present invention will be described with reference to the following drawings, in which:

[0011] Figure 1 A functional block diagram of an exemplary system suitable for implementing the systems and methods disclosed herein is shown.

[0012] Figure 2 is a schematic diagram of one embodiment of a dual reservoir pump mechanism.

[0013] Figure 3 is a cross-sectional perspective view of a primary embodiment of the novel pump mechanism disclosed herein.

[0014] Figure 4 (a) Yes Figure 3 A perspective view of an embodiment of , showing the pump mechanism in a filling configuration; Figure 4 (b) is a cross-sectional view of the pump mechanism in the filling configuration.

[0015] Figure 5 (a) Yes Figure 3 A perspective view of an embodiment of , showing the pump mechanism in an emptying configuration; Figure 5 (b) is a cross-sectional view of the pump mechanism in the emptying configuration.

[0016] Figure 6 yes Figure 3 A transparent view of a portion of an external reservoir of an embodiment showing the connection between the access port and the interior of the external reservoir. DETAILED DESCRIPTION

[0017] The present disclosure proposes various systems, components and methods for moving liquid drugs from a liquid reservoir in a drug delivery device to a patient interface such as a needle or cannula. The embodiments described herein provide one or more advantages over conventional prior art systems, components and methods, namely, a smaller overall footprint of the drug delivery device.

[0018] Various embodiments of the present invention include systems and methods for delivering medication to a user using a medication delivery device (sometimes referred to herein as a "pod") automatically or based on a wireless signal received from an electronic device. In various embodiments, the electronic device can be a user device, including a smartphone, a smart watch, a smart necklace, a module attached to the medication delivery device, or any other type or kind of electronic device that can be carried or worn by a user and executes an algorithm for calculating the number and dosage of medication delivery.

[0019] For example, the user device may execute an "artificial pancreas" (AP) algorithm for calculating the number and dosage of insulin delivery. The user device may also communicate with a sensor, such as a glucose sensor or a continuous glucose monitor (CGM), which is used to collect data about a user's physical attributes or condition, such as glucose levels. The sensor may be disposed in or on the user's body and may be part of the drug delivery device, or may be a separate device.

[0020] Alternatively, the drug delivery device may communicate with the sensor instead of, or in addition to, communication between the sensor and the user device. The communication may be direct (e.g., if the sensor is integrally formed with or part of the drug delivery device) or remote / wireless (e.g., if the sensor is disposed in a different housing than the drug delivery device). In these embodiments, the drug delivery device includes computing hardware (e.g., a processor, memory, firmware, etc.) that executes some or all of the algorithms for calculating the number and dosage of drug delivery.

[0021] Figure 1 A functional block diagram of an exemplary drug delivery system 100 suitable for implementing the systems and methods described herein is shown. The drug delivery system 100 can implement a drug delivery algorithm (and / or provide functionality for a drug delivery algorithm), such as an artificial pancreas (AP) application, to manage or control the automatic delivery of a drug or medicament such as insulin to a user (e.g., to maintain normoglycemia - normal levels of glucose in the blood). The drug delivery system 100 can be an automatic drug delivery system, which can include a drug delivery device 102 (which can be wearable), an analyte sensor 108 (which can also be wearable), and a user device 105. The types of drugs that can be delivered by the drug delivery device include, for example, insulin, GLP-1, pramlintide, glucagon, morphine, antihypertensive drugs, chemotherapy drugs, fertility drugs, arthritis drugs, or the like, or a combination of two or more of GLP-1, pramlintide, and insulin.

[0022] In an optional example, the drug delivery system 100 may also include an accessory device 106 , such as a smart watch, a personal assistant device, an insulin smart pen, or the like, which may communicate with other components of the system 100 via wired or wireless communication links 191 - 193 . User Device

[0023] 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 therapy management device, or the like. In an example, the user device 105 may include 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, which may be implemented as a processor 151, for executing processing based on programming code stored in the device memory 153 (e.g., a user application 160 including a drug delivery algorithm (MDA) 161) to manage, for example, the user's blood glucose level, and / or for controlling the delivery of drugs, medicaments, or therapeutic agents to the user, and for providing other functions, such as calculating carbohydrate compensation doses, correcting bolus doses, etc., as described below. The user device 105 may be used to enable, disable, trigger needle / cannula insertion, program, adjust settings, and / or control the operation of the drug delivery device 102 and / or the analyte sensor 103 and the optional smart accessory device 106.

[0024] The processor 151 may also be configured to execute programming code stored in the device memory 153 (e.g., user application 160). The user application 160 may be a computer application that is operable to deliver medication based on information received from the analyte sensor 103, the cloud-based service 111, and / or the user device 105 or the optional accessory device 106. The memory 153 may also store programming code for operating, for example, a user interface 158 (e.g., a touch screen device, a camera, or the like), a communication interface 154, and the like. When executing the user application 160, the processor 151 may be configured to implement instructions and notifications related to meal intake, blood glucose measurement, and the like. The user interface 158 may be controlled by the processor 151 and configured to present a graphical user interface that enables input of meal announcements, adjustment setting selections, and the like as described herein.

[0025] In a specific example, when the user application 160 includes the MDA 161, the processor 151 is also configured to execute the diabetes treatment plan (which can be stored in the memory) managed by the user application 160. In addition to the functions mentioned above, when the user application 160 is an AP application, it can also provide the functions of determining a carbohydrate compensation dose, correcting a bolus dose, and determining a real-time basic dose according to the diabetes treatment plan. In addition, the user application 160 provides the function of outputting a signal to the drug delivery device 102 via the communication interface 154 to deliver the determined bolus dose and / or basic dose.

[0026] The communication interface 154 may include one or more transceivers operating according to one or more radio frequency protocols. In one embodiment, the transceiver may include a cellular transceiver and a Bluetooth® transceiver. The communication interface 154 may be configured to receive and send signals containing information available to the user application 160.

[0027] The user device 105 may also be provided with one or more output devices 155 , which may be, for example, a speaker or a vibration transducer, to provide various signals to the user. Drug delivery devices

[0028] In various exemplary embodiments, the drug delivery device 102 may include a reservoir 124 and a drive mechanism 125 that can be controlled by a controller 121 executing a drug delivery algorithm (MDA) 129 stored in a memory 123, which may perform some or all of the functions of the AP application described above, such that the drug delivery device 102 may not require a user device 105 to perform drug delivery and control. Alternatively, the controller 121 may 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 communicating with the drug delivery device 102 via a communication link 194. The drive mechanism 125 may operate, for example, to longitudinally translate a plunger through the reservoir, thereby forcing liquid drug through the outlet fluid port to the needle / cannula 186.

[0029] In an alternative embodiment, the drug delivery device 102 may also include an optional second reservoir 124-2 and a second drive mechanism 125-2 capable of independently delivering two different liquid drugs. For example, the reservoir 124 may be filled with insulin, while the reservoir 124-2 may be filled with pramlintide, GLP-1, glucagon, or another drug. In some embodiments, each reservoir 124, 124-2 may be configured with a separate drive mechanism 125, 125-2, respectively, which may be controlled individually by the controller 121 under the guidance of the MDA 129. The two reservoirs 124, 124-2 may be connected to a common needle / cannula 186.

[0030] The drug delivery device 102 may optionally be configured with a user interface 127 that provides a means for receiving input from a user and a means for outputting information to the user. The user interface 127 may include, for example, light emitting diodes, buttons on the housing of the drug delivery device 102, electroacoustic transducers, microdisplays, microphones, accelerometers for detecting movement of the device or user gestures (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 allow the drug delivery device 102 to output information for presentation to the user (e.g., an alarm signal or the like).

[0031] The drug delivery device 102 includes a patient interface 186 for connecting to a user through an interface to deliver liquid drugs. The patient interface can be, for example, a needle, cannula, or microneedle array for delivering drugs into the user's body (which can be done subcutaneously, intraperitoneally, or intravenously). The drug delivery device 102 also includes a mechanism for inserting the needle / cannula 186 into the user's body, which can be integrally formed with the drug delivery device 102 or can be attached to the drug delivery device 102. In one embodiment, the insertion mechanism can include an actuator that inserts the needle / cannula 186 under the user's skin and then retracts the needle, leaving the cannula in place. The actuator can be triggered by the user device 105, or can be a manual firing mechanism including a spring or other energy storage mechanism that causes the needle / cannula 186 to penetrate the user's skin.

[0032] In one embodiment, the drug delivery device 102 includes 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, or the like. The controller 121 may communicate with the user device 105 and the analyte sensor 108, for example, via the communication interface 126.

[0033] In some embodiments, the drug delivery device 102 may be provided with one or more sensors 184. The sensor 184 may include one or more of a pressure sensor, a power sensor, or the like, which may be communicatively coupled to the controller 121 and provide various signals. For example, the pressure sensor may be configured to provide an indication of the fluid pressure detected in the fluid path between the patient interface 186 and the reservoir 124. The pressure sensor may be coupled to an actuator for inserting the patient interface 186 into the user's body or may be formed integrally with the actuator. In an example, the controller 121 is operable to determine the drug infusion rate based on an indication of the fluid pressure. The drug infusion rate may be compared with an infusion rate threshold, and the comparison result may be used to determine the active insulin amount (IOB) or the total insulin amount (TDI) for the whole day. In one embodiment, the analyte sensor 108 may be formed integrally with the drug delivery device 102.

[0034] The drug delivery device 102 also includes a power source 128 , such as a battery, a piezoelectric device, an energy harvesting device, or the like, for providing electrical energy to the controller 121 , the memory 123 , the drive mechanism 125 , and / or other components of the drug delivery device 102 .

[0035] The drug delivery device 102 can be configured to perform and execute the processes required to deliver a dose of medication to a user without input from the user device 105 or the optional accessory device 106. As described in more detail, the MDA 129 can be operable, for example, to determine the amount of insulin to be delivered, the IOB, remaining insulin, and the like, and to cause the controller 121 to enable the drive mechanism 125 to deliver medication from the reservoir 124. The MDA 129 can receive data received from the analyte sensor 108 or from the user application 160 as input data.

[0036] The reservoir 124, 124-2 can be configured to store a drug, medicament, or therapeutic agent suitable for automatic delivery, such as insulin, pramlintide, GLP-1, a combination of insulin and GLP-1, glucagon, morphine, blood pressure medication, chemotherapy drugs, fertility drugs, arthritis medication, or the like.

[0037] The drug delivery device 102 may be a wearable device and may be attached to the body of a user (e.g., a patient or diabetic) at an attachment location and may deliver any therapeutic agent, including any drug or medicament, to the user at or around the attachment location. The surface of the drug delivery device 102 may include an adhesive to facilitate attachment to the user's skin.

[0038] When configured to communicate with an external device such as the user device 105 or the analyte sensor 108, the drug delivery device 102 can receive signals from the user device 105 or from the analyte sensor 108 via a wired or wireless link 194. The controller 121 of the drug delivery device 102 can receive and process signals from the corresponding external device and implement drug delivery to the user according to a diabetes treatment regimen or other drug delivery regimen. Accessories

[0039] The optional accessory device 107 can be a wearable smart device, such as a smart watch (e.g., Apple Watch®), smart glasses, smart jewelry, a wearable device that supports a global positioning system, a wearable fitness device, smart clothing, or the like. Similar to the user device 105, the accessory device 107 can also be configured to perform various functions, including controlling the drug delivery device 102. For example, the accessory device 107 can include a communication interface 174, a processor 171, a user interface 178, and a memory 173. The user interface 178 can be a graphical user interface presented on a touch screen display of the smart accessory device 107. The memory 173 can store programming code to operate different functions of the smart accessory device 107 and an instance of the user application 160 or a streamlined version of the user application 160 with reduced functionality. In some cases, the accessory device 107 can also include various types of sensors. Analyte Sensors

[0040] The analyte sensor 108 may include a controller 131, a memory 132, a sensing / measuring 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 a controller 121 of the drug delivery device 102. The memory 132 may be configured to store information and programming code 136.

[0041] The analyte sensor 108 may be configured to detect one or more different analytes, such as glucose, lactate, ketones, uric acid, sodium, potassium, alcohol levels, or the like, and output a detection result such as a measurement value or the like. In an exemplary embodiment, the analyte sensor 108 may be configured as a continuous glucose monitor (CGM) to measure blood glucose values ​​at predetermined time intervals (e.g., every 5 minutes, every 1 minute, or the like). The communication interface 135 of the analyte sensor 108 may have circuitry operating as a transceiver for transmitting the measured blood glucose value to the user device 105 via the wireless link 195, or communicating with the drug delivery device 102 via the wireless communication link 108. Although referred to herein as an analyte sensor 108, the sensing / measuring device 33 of the analyte sensor 108 may include one or more additional sensing elements, such as a glucose measuring element, a heart rate monitor, a pressure sensor, or the like. The controller 131 may include discrete dedicated logic and / or components, an application specific integrated circuit, a microcontroller or processor that executes software instructions, firmware and programming instructions stored in a memory (eg, memory 132 ), or any combination thereof.

[0042] Similar to the controller 121 of the drug delivery device 102 , the controller 131 of the analyte sensor 108 is operable to perform a number of functions. For example, the controller 131 may be configured by programming code 136 to manage the collection and analysis of data detected by the sensing and measuring device 133 .

[0043] Although the analyte sensor 108 is Figure 1102, in various embodiments, 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 the drug delivery device 102 and may be integrally formed with the drug delivery device 102 and may be contained within the same housing as the drug delivery device 102 or within a housing attachable thereto. In such an exemplary configuration, the controller 121 may independently implement the functions required for proper drug delivery without any external input from the user device 105, the cloud-based service 111, another sensor (not shown), the optional accessory device 106, or the like. Cloud-based services

[0044] The drug delivery system 100 can communicate with or receive services from a cloud server 122 that provides cloud-based services 111. The services provided by the cloud server 112 may include data storage for storing personal or anonymous data, such as blood glucose measurements, historical IOB or TDI, previous carbohydrate compensation doses, and other forms of data. In addition, the cloud-based service 111 can process anonymized data from multiple users to provide generalized information related to TDI, insulin sensitivity, and IOB, and the like. The communication link 115 that couples the cloud server 112 to other components of the system 100 (e.g., the devices 102, 105, 106, 108 of the system 100) can be a cellular link, a Wi-Fi link, a Bluetooth® link, or a combination thereof. Communication Link

[0045] The 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. For example, the 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 the corresponding communication interfaces 126, 135, 154, and 174. Operation Example

[0046] In an operational example, the user application 160 implements a graphical user interface as the primary interface for interacting with the user and for starting and stopping the drug delivery device 102, programming basic and bolus dose calculator settings for manual mode, and programming settings specifically for automatic mode (hybrid closed loop or closed loop).

[0047] The user application 160 provides a graphical user interface 158 that allows large text, graphics, and on-screen information instructions to prompt the user through the setup process and use of the system 100. It will also be used to program a user-customized basal insulin delivery profile for the drug delivery device 102, check the status of the drug delivery device 102, initiate a bolus dose of insulin, make changes to the patient's insulin delivery profile, handle system warnings and alarms, and allow the user to switch between automatic and manual modes.

[0048] The user application 160 may be configured to operate in a manual mode in which it will deliver insulin at a programmed basal rate and a user defined bolus quantity, with the option of setting a temporary basal rate condition. The controller 121 will also have the ability to function as a sensor augmented pump in manual mode by using the sensor glucose data provided by the analyte sensor 108 to populate the bolus dose calculator.

[0049] The user application 160 can be configured to operate in an automatic mode, wherein the user application 160 supports the use of multiple target blood glucose values. For example, in one embodiment, the target blood glucose value can be in the range of 110-150 mg / dL, in increments of 10 mg / dL, in increments of 5 mg / dL, or other increments, but preferably in increments of 10 mg / dL. The user's experience will reflect the current setup process, whereby the medical staff helps the user program the basal rate, glucose target, and bolus dose calculator settings. These in turn will inform the user application 160 insulin dosage parameters. Based on the total amount of insulin (TDI) delivered throughout the day during each use of the drug delivery device 102, the insulin dosage parameters will be adjusted over time. The user can implement a temporary hypoglycemia protection mode for different durations in the automatic mode. In the hypoglycemia protection mode, the algorithm reduces insulin delivery and is intended to be used for temporary durations (e.g., during exercise) when insulin sensitivity is expected to be higher.

[0050] The user application 160 (or MDA 129) can provide periodic insulin bolus doses based on past glucose measurements and / or predicted glucose within a prediction range (e.g., 60 minutes). Optimal postprandial control may require the user to give pre-meal doses in the same manner as current pump therapy, but normal operation of the user application 160 will compensate for missed pre-meal doses and alleviate prolonged hyperglycemia. The user application 160 uses a target control strategy that attempts to achieve and maintain a set target glucose value, thereby reducing the duration of prolonged hyperglycemia and hypoglycemia.

[0051] 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 readings) may be delivered to the drug delivery device 102 via link 196 and then forwarded to the user device 105 via link 194. In some embodiments, in order to enable communication between the analyte sensor 108 and the user device 105, the serial number of the analyte sensor must be entered into the user application 160.

[0052] The user application 160 may provide the ability to calculate a recommended bolus dose by using a bolus dose calculator. For the convenience of the user, the bolus dose calculator is provided to help determine the recommended bolus dose based on ingested carbohydrates, a recent blood glucose reading (or blood glucose reading if a finger stick is used), a programmable correction factor, an insulin to carbohydrate ratio, a target glucose value, and active insulin (IOB). The IOB is estimated by the user application 160 by an algorithm taking into account any manual boluses and delivered insulin. Description of Embodiments

[0053] Figure 3 An exemplary embodiment of the present invention is shown in which there is no input or output port on the moving reservoir in a dual reservoir pump mechanism. Figure 3 In the illustrated embodiment, the outer reservoir 202 is a stationary reservoir, while the inner reservoir 204 is a movable reservoir that moves back and forth within the outer reservoir 202 by linear translation.

[0054] During the filling process, it is necessary to ensure that all (or nearly all) of the trapped air in the outer reservoir 202 and the inner reservoir 204 can be removed from the pump mechanism. In order to properly remove air from the pump mechanism during the filling process, it is necessary to have the filling port and the dispensing port located on different reservoirs, one of which must be movable. Figure 2 As shown, fluid enters the pump mechanism from the fill port 212 and pushes air trapped in the outer reservoir 202 into the inner reservoir 204 through the plunger tube 206. Any air trapped in the inner reservoir 204 escapes from the system through the dispensing port 210. However, as previously mentioned, it is preferred that there be neither a fill port nor a dispensing port on the mobile reservoir.

[0055] Figure 3 The embodiment in solves this problem by adding an additional fluid path 302 disposed in the plunger tube 206, which is in fluid communication with the dispensing port 304, so that the dispensing port 304 is relocated to the stationary reservoir 202 (in this example, the external reservoir). Figure 3The black arrows in show the flow of fluid (or, initially, air flow) from the fill port 212 to the dispensing port 304 during the filling process. In the absence of an additional fluid path 302 connecting the dispensing port 304 to the internal reservoir 204, air would continue to be trapped within the internal reservoir 204 after the filling process is complete, thereby reducing the amount of fluid (e.g., liquid medication) that can be retained within the pump mechanism.

[0056] During the filling process, the fluid enters the filling port 212 and advances through the plunger tube 206, where the fluid begins to fill both the internal reservoir 204 and the external reservoir 202 as the internal and external reservoirs move apart. That is, due to the hydraulic action of the fluid entering the external reservoir 202, the internal reservoir 202 is forced to slide along the direction "A". Any air left in the external reservoir 202 will enter the internal reservoir 204 through the push rod 206, and any air left in the internal reservoir 204 will be forced through the fluid path 302 and will leave the system through the dispensing port 304. The additional fluid path 302 and the dispensing port 304 are filled with fluid first. The hydrophobic vent can be located at the distal end of the outlet port 304, and when the vent is wetted by the fluid, the dispensing port 304 is blocked, because the hydrophobic vent will not let the fluid pass once it is wetted. At this point, the air has been forced to be discharged from the additional fluid path 206 and the dispensing port 304. As the fluid continues to push into the fill port 212, the pressure increases, which causes the inner reservoir 204, which has a plunger 214 at one end, to move in direction "A". The inner reservoir 202 and the outer reservoir 304 are filled with fluid simultaneously. Once both reservoirs have been filled, there is little air left in the pump mechanism.

[0057] Figure 4 (a) shows an exemplary embodiment of a dual-reservoir pump mechanism in a filling configuration, Figure 4 (b) shows a cross-sectional view of the pump mechanism in the filling configuration. Figure 5 (a) shows the pump mechanism in the emptying configuration, Figure 5(b) shows a cross-sectional view of the pump mechanism in an evacuated configuration. As shown, both the fill port 212 and the dispensing port 304 are located on the external reservoir 202 and are sealed using pierceable septa 402 and 404, respectively. These cross-sectional views show how the outlet port 304 is extended by using an additional fluid path 302 extending from the rear of the external reservoir 202 through the plunger tube 206 to the internal reservoir 204 so that the fill port 212 and the dispensing port 304 can be stationary relative to the external reservoir 202 even when the internal reservoir 202 is moved. One end of the additional fluid path 302 is located at the end of the plunger tube 206 to allow fluid to pass through the external reservoir 202 and the plunger tube 206 before leaving the reservoir, which facilitates the removal of air from the dual reservoir pump mechanism. The other end of the dispensing port 304 is fixed to the insertion mechanism (not shown) and provides a fluid path from the drug delivery device to the patient's body.

[0058] Figure 6 is a transparent view of a portion of the external reservoir 202 illustrating a fluid path 602 from the fill port 212 to the interior of the external reservoir 202 according to an exemplary embodiment.

[0059] As will be appreciated by those of ordinary skill in the art, exemplary embodiments have been provided herein that use a specific dual reservoir configuration in which the external reservoir 202 is fixed relative to the housing of the drug delivery device 100, and the internal reservoir 204 is moved out of the external reservoir 202 during the filling process and moved into the external reservoir 202 during the fluid dispensing process. The filling port 212 and the dispensing port 304 extend through the end wall 306 of the external reservoir 202 so that they remain stationary during the movement of the internal reservoir. In other embodiments, the filling port 212 and the dispensing port 304 are interchangeable, and the concept can be used for two fluid ports. Therefore, the scope of the present invention is intended to include these embodiments in which the internal reservoir is rigidly fixed relative to the housing of the drug delivery device 100, and in which the internal reservoir is nested in the external reservoir by moving the external reservoir. In this case, the filling port 212 is in fluid communication with the internal reservoir 204, and the dispensing port 304 is in fluid communication with the external reservoir 202 via an additional fluid path 302 extending through the hollow tube 206. In this embodiment, the filling port 212 and the dispensing port 304 extend through the end wall of the inner reservoir 204 so that they remain stationary during the movement of the outer reservoir. Other embodiments of pump mechanisms with moving reservoirs not specifically discussed herein are also considered to be within the scope of the present invention. The present invention is not meant to be limited to the exemplary dual reservoir pump mechanism used herein to illustrate the present invention.

[0060] The following examples relate to various embodiments of the systems and methods disclosed herein for implementing an automated drug delivery system having a dual-reservoir pumping mechanism.

[0061] Example 1 is a first embodiment of a pump mechanism, which includes an external reservoir and an internal reservoir configured to linearly translate into and out of the external reservoir; a stationary plunger disposed inside the internal reservoir; a hollow tube supporting the stationary plunger and extending between the internal reservoir and the external reservoir to connect the internal reservoir fluid to the external reservoir; and a first fluid port connected to the fluid of another reservoir and a second fluid port connected to the fluid of the internal reservoir, wherein one of the first fluid port or the second fluid port extends through the hollow tube.

[0062] Example 2 is an extension of Example 1 or any other example disclosed herein, wherein the external reservoir is rigidly attached to a structure external to the pumping mechanism.

[0063] Example 3 is an extension of Example 2 or any other example disclosed herein, wherein a second fluid port extends through the hollow tube, the second fluid port extends from an end wall of the external reservoir, and the first fluid port and the second fluid port remain stationary as the internal reservoir moves into and out of the external reservoir.

[0064] Example 4 is an extension of Example 1 or any other example disclosed herein, wherein the internal reservoir is rigidly attached to a structure external to the pumping mechanism.

[0065] Example 5 is an extension of Example 4 or any other example disclosed herein, wherein the first fluid port extends through the hollow tube, the first fluid port extends from the end wall of the internal reservoir, and the first fluid port and the second fluid port remain stationary when the other reservoir moves relative to the internal reservoir.

[0066] Example 6 is an extension of Example 1 or any other example disclosed herein, wherein the inner reservoir and the outer reservoir move apart while the pumping mechanism is filling with fluid.

[0067] Example 7 is an expansion of Example 1 or any other example disclosed herein, further comprising a drive mechanism for moving the inner reservoir and the outer reservoir toward each other when the fluid in the pumping mechanism is dispensed.

[0068] Example 8 is an extension of Example 1 or any other example disclosed herein, further comprising a fluid seal between an inner surface of the outer reservoir and an outer surface of the inner reservoir.

[0069] Example 9 is an extension of Example 1 or any other example disclosed herein, further comprising a fluid seal disposed on a circumferential surface of the stationary plunger to form a fluid seal between the plunger and an inner surface of the internal reservoir.

[0070] Example 10 is an extension of Example 1 or any other example disclosed herein, further comprising a fluid seal between the hollow tube and an end wall of the internal reservoir.

[0071] Example 11 is an extension 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 flat circle, and a rectangle with rounded corners.

[0072] Example 12 is an extension of Example 10 or any other example disclosed herein, wherein a hollow tube extends through an end wall of the inner reservoir, thereby enabling fluid communication between the inner reservoir and the outer reservoir.

[0073] Example 13 is a second embodiment of a pumping mechanism, which includes an external reservoir rigidly attached to a structure outside the pumping mechanism; and an internal reservoir configured to linearly translate into and out of the external reservoir; a stationary plunger disposed inside the internal reservoir; a hollow tube supporting the stationary plunger and extending between the internal reservoir and the external reservoir to connect the internal reservoir fluid to another reservoir; a first fluid port connected to the external reservoir and a second fluid port connected to the internal reservoir and extending through the hollow tube, wherein the second fluid port extends through an end wall of the external reservoir so that the first fluid port and the second fluid port remain stationary when the internal reservoir moves into and out of the external reservoir.

[0074] Example 14 is a third embodiment of a pumping mechanism, which includes an internal reservoir rigidly attached to a structure outside the pumping mechanism; and an external reservoir configured to linearly translate so that the internal reservoir is nested within the external reservoir; a stationary plunger disposed inside the internal reservoir; a hollow tube supporting the stationary plunger and extending between the internal reservoir and the external reservoir to connect the internal reservoir fluid to the external reservoir; a first fluid port connected to the internal reservoir fluid and a second fluid port connected to the external reservoir fluid and extending through the hollow tube, wherein the first fluid port extends through an end wall of the external reservoir so that when the external reservoir moves toward the internal reservoir, the first fluid port and the second fluid port remain stationary.

[0075] The software-related implementations of the technology described herein may include, but are not limited to, firmware, application-specific software, or any other type of computer-readable instructions that can be executed by one or more processors. Computer-readable instructions may be provided by non-transitory computer-readable media. The hardware-related implementations of the technology described herein may include, but are not limited to, integrated circuits (ICs), application-specific integrated circuits (ASICs), field programmable arrays (FPGAs), and / or programmable logic devices (PLDs). In some examples, the technology described herein and / or any system or component described herein may be implemented by a processor that executes computer-readable instructions stored on one or more memory components.

[0076] For those skilled in the art of the present invention, many modifications and variations of the present invention can be realized. The implementation provided herein includes the size, shape, grade composition and specification of various parts or the arrangement of parts and the description of specific manufacturing process, which should be regarded as merely exemplary and not meant to limit the present invention in any way. As will be appreciated by those skilled in the art, many changes of the implementations discussed herein falling within the scope of the present invention are possible. In addition, it should be understood that, without departing from the spirit and scope of the present invention, the features of the various embodiments described herein are not mutually exclusive, and may exist in various combinations and arrangements, even if these combinations or arrangements are not clearly indicated in this article. Therefore, the method and apparatus disclosed herein should not be regarded as a limitation of the present invention, but should be regarded as an explanation of the present invention. The scope of the present invention is defined by the appended claims.

Claims

1. Pumping mechanism, including: External reservoir; an internal reservoir configured to be positionable within the external reservoir; a stationary plunger; a hollow tube supporting the stationary plunger and extending between the inner reservoir and the outer reservoir to fluidly couple the inner reservoir to the outer reservoir; a first fluid port in fluid communication with the external reservoir; as well as a second fluid port in fluid communication with the internal reservoir; Wherein one of the first fluid port or the second fluid port extends through the hollow tube.

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

3. The pumping mechanism according to claim 2, wherein: the second fluid port extending through the hollow tube; the second fluid port extends through an end wall of the external reservoir; and The first and second fluid ports remain stationary as the inner reservoir moves into and out of the outer reservoir.

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

5. The pumping mechanism of claim 4, wherein: the first fluid port extending through the hollow tube; The first fluid port extends through an end wall of the internal reservoir; and The first and second fluid ports remain stationary as another reservoir moves to nest with the inner reservoir.

6. The pumping mechanism of claim 1, wherein the inner reservoir and the outer reservoir move apart when the pumping mechanism is filling with fluid.

7. The pumping mechanism according to claim 1, further comprising: A drive mechanism is provided for moving the inner reservoir and the outer reservoir toward each other when fluid within the pumping mechanism is dispensed.

8. The pumping mechanism of claim 1, further comprising: A fluid seal is positioned between the inner surface of the outer reservoir and the outer surface of the inner reservoir.

9. The pumping mechanism of claim 1, further comprising: A fluid seal is disposed on a circumferential surface of the stationary plunger to form a fluid seal between the plunger and an interior surface of the internal reservoir.

10. The pumping mechanism of claim 8, further comprising: A fluid seal is disposed between the hollow tube and an end wall of the internal reservoir.

11. The pumping mechanism of claim 1, wherein the cross-sectional shape of the inner reservoir and the outer reservoir is selected from the group consisting of an oval, a flat circle, and a rectangle with rounded corners.

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

13. A drug delivery device, comprising: A pumping mechanism, the pumping mechanism comprising: External reservoir; an internal reservoir configured to be positionable within the external reservoir; a stationary plunger; a hollow tube supporting the stationary plunger and extending between the inner reservoir and the outer reservoir to fluidly couple the inner reservoir to the outer reservoir; a first fluid port in fluid communication with the external reservoir; and a second fluid port in fluid communication with the internal reservoir; wherein one of the first fluid port or the second fluid port extends through the hollow tube; and A controller is used to control the operation of the pumping mechanism.

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

15. The drug delivery device of claim 13, further comprising: A drive mechanism is provided for moving the inner reservoir and the outer reservoir toward each other when fluid within the pumping mechanism is dispensed.

Images