Patent Publication Number: US-2023158231-A1

Title: Automated filling device for wearable infusion pump with air removal and detection capabilities

Description:
CROSS-REFERENCE TO RELATED APPLICATION 
     This Application claims priority from U.S. Provisional Application 63/017,377 filed Apr. 29, 2020, in the U.S. Pat. and Trademark Office, the disclosure of which is incorporated herein by reference in its entirety. 
    
    
     BACKGROUND 
     1. Field 
     Apparatuses and methods consistent with example embodiments relate to medication delivery devices and filling devices therefor, and more particularly, to filling devices enabling wireless communication with delivery devices. 
     2. Description of the Related Art 
     Diabetes is a group of diseases characterized by high levels of blood glucose resulting from the inability of diabetic patients to maintain proper levels of insulin production when required. Complications from diabetes can be minimized by utilizing one or more treatment options. The treatment options for diabetic patients include specialized diets, oral medications and/or insulin therapy. The main goal of diabetes treatment is to control the diabetic patient’s blood glucose or sugar level. However, maintaining proper diabetes management may be complicated because it has to be balanced with the activities of the diabetic patient. Type 1 diabetes (T1D) patients are required to take insulin (e.g., via injections or infusion) to move glucose from the bloodstream because their bodies generally cannot produce insulin. Type 2 diabetes (T2D) patients generally can produce insulin but their bodies cannot use the insulin properly to maintain blood glucose levels within medically acceptable ranges. 
     For the treatment of T1D and sometimes T2D, there are two principal methods of daily insulin therapy. In the first method, diabetic patients use syringes or insulin pens to self-inject insulin when needed. Another effective method for insulin therapy and managing diabetes is infusion therapy or infusion pump therapy in which an insulin pump is used. The insulin pump can provide continuous infusion of insulin to a diabetic patient at varying rates to more closely match the functions and behavior of a properly operating pancreas of a non-diabetic person that produces the required insulin. Infusion pump therapy requires an infusion cannula, typically in the form of an infusion needle or a flexible catheter, that pierces the diabetic patient’s skin and through which infusion of insulin takes place. 
     In infusion therapy, insulin doses are typically administered at a basal rate and in a bolus dose. When insulin is administered at a basal rate, insulin is delivered continuously over 24 hours to maintain the diabetic patient’s blood glucose levels in a consistent range between meals and rest, typically at nighttime. Insulin pumps may also be capable of programming the basal rate of insulin to vary according to the different times of the day and night. In contrast, a bolus dose is typically administered when a diabetic patient consumes a meal, and generally provides a single additional insulin injection to balance the consumed carbohydrates. Insulin pumps may be configured to enable the diabetic patient to program the volume of the bolus dose in accordance with the size or type of the meal that is consumed by the diabetic patient. In addition, insulin pumps may also be configured to enable the diabetic patient to infuse a correctional or supplemental bolus dose of insulin to compensate for a low blood glucose level at the time when the diabetic patient is calculating the bolus dose for a particular meal that is to be consumed. 
     An insulin pump may comprise an insulin delivery device that is an integrated device combining most or all of the necessary fluidic components in a single housing. Generally, the housing is adhesively attached to an infusion site on the patient’s skin, and does not require the use of a separate infusion or tubing set. A delivery device containing insulin may adhere to the skin and deliver insulin over a period of time via an integrated subcutaneous cannula. Some delivery devices may wirelessly communicate with a separate controller device. Delivery devices are replaced on a frequent basis, such as every three days, or when the medication reservoir is exhausted. Otherwise, complications may occur, such as restriction in the cannula or the infusion site. 
     When a new delivery device is to be used it is activated and paired with the remote, attached to a patient, and setup is completed via a wireless connection with the remote. 
     When a new device is first used, it is paired with a wireless controller which programs the device. Current smartphones may be technically capable of all of the wireless controller’s operations. However, due to legal restrictions, off-the-shelf smartphones are only permitted to receive data from a delivery device, and cannot be used to send commands or programming to the device. 
     When a self-injection or self-infusion device is filled from a standard vial, the vial from which it is filled may be emptied before the device is entirely filled. 
     In delivery device designs, tubes, such as plastic tubes, may be employed as fluid pathways to route fluid flow from one internal component to another. For example, a tube can connect a medication reservoir with a delivery needle. Typically, medication is drawn from the reservoir via a vacuum. However, in such a configuration, it is difficult to remove entrapped air from the medication. This is because the vacuum draws the medication via a negative pressure with respect to atmospheric pressure. Medication at a negative pressure will draw in air instead of releasing air. The presence of air in the delivery device, either in a fill port or a reservoir bag, for example, may cause inaccuracies in delivery of the bolus dose. 
     SUMMARY 
     Example embodiments may address at least the above problems and/or disadvantages and other disadvantages not described above. Also, example embodiments are not required to overcome the disadvantages described above, and may not overcome any of the problems described above. 
     According to an aspect of an example embodiment, a medication filling device is provided, comprising: a vial attachment component comprising: a housing configured to hold a medication vial therein; a pump; an empty vial detection unit configured to detect whether a vial attached to the vial attachment component is empty, a processor configured to receive a signal from the empty vial detection unit indicating whether the vial attached to the vial attachment component is empty; and a user interface configured to output an indication to a user indicating whether the vial is empty 
     The empty vial detection unit may comprise a light source, and a light sensor, wherein the light sensor is disposed such that light, output from the light source and transmitted through a vial containing liquid medication, is incident on the light sensor and light, output from the light source and transmitted through a vial empty of medication, is not incident on the light sensor. 
     The pump may be operable in forward and reverse directions to pump liquid medication between a vial and a medication delivery device. 
     The user interface may comprise one or more light emitting diodes. 
     The medication filling device may further comprise a communication circuit operable to transmit a wireless signal. 
     The communication circuit may comprise an antenna and a match circuit. 
     The medication filling device may further comprise an upper lid; and a lower case hinged to the upper lid, the lower case configured to receive a medication delivery device therein. 
     According to an aspect of another example embodiment, a medication filling device is provided, comprising: a housing configured to hold a medication delivery device therewithin; a vial attachment component comprising: a housing configured to hold a medication vial therein; a pump; a processor; a communication circuit operable to transmit a wireless signal to a medication delivery device. 
     According to an aspect of another example embodiment, a medication filling system comprises a communication circuit operable to receive a wireless signal; a medication filling device comprising: a housing configured to attach to the medication delivery device; a vial attachment component comprising: a housing configured to hold a medication vial therein; a pump; an empty vial detection unit configured to detect whether a vial attached to the vial attachment component is empty, a processor configured to receive a signal from the empty vial detection unit indicating whether the vial attached to the vial attachment component is empty; a user interface output configure to output an indication to a user indicating whether the vial is empty; and a communication circuit operable to transmit a wireless signal. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The above and/or other example aspects and advantages will become apparent and more readily appreciated from the following description of example embodiments, taken in conjunction with the accompanying drawings in which: 
         FIG.  1    is a perspective view of a delivery device according to an example embodiment; 
         FIG.  2    is an exploded view of the various components of the delivery device of FIG. A, illustrated with a cover; 
         FIG.  3    is a perspective view of an alternative design of a delivery device according to an example embodiment; 
         FIG.  4    is a block diagram of a delivery device according to an example embodiment; 
         FIG.  5    is a filling device according to an example embodiment; 
         FIGS.  6 A- 6 C  illustrate placement of a delivery device into a base and placement of a vial attachment component onto the base of a filling device, according to an example embodiment; 
         FIG.  7    is a pump mechanism according to an example embodiment; 
         FIG.  8    is a diagram of an empty vial detection sensor according to an example embodiment; 
         FIGS.  9 A and  9 B  illustrate operation of an empty vial detection sensor according to an example embodiment; 
         FIG.  10    illustrates a filling device in communication with a delivery device, according to an example embodiment; and 
         FIG.  11    is a block diagram of a filling device according to an example embodiment. 
     
    
    
     DETAILED DESCRIPTION 
     Reference will now be made in detail to example embodiments which are illustrated in the accompanying drawings, wherein like reference numerals refer to like elements throughout. In this regard, the example embodiments may have different forms and may not be construed as being limited to the descriptions set forth herein. 
     It will be understood that the terms “include,” “including,” “comprise,” and/or “comprising,” when used in this specification, specify the presence of stated features, integers, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and/or groups thereof. 
     It will be further understood that, although the terms “first,” “second,” “third,” etc., may be used herein to describe various elements, components, regions, layers and/or sections, these elements, components, regions, layers and/or sections may not be limited by these terms These terms are only used to distinguish one element, component, region, layer or section from another element, component, region, layer or section. 
     As used herein, the term “and/or” includes any and all combinations of one or more of the associated listed items. Expressions such as “at least one of,” when preceding a list of elements, modify the entire list of elements and do not modify the individual elements of the list. In addition, the terms such as “unit,” “-er (-or),” and “module” described in the specification refer to an element for performing at least one function or operation, and may be implemented in hardware, software, or the combination of hardware and software. 
     Various terms are used to refer to particular system components. Different companies may refer to a component by different names - this document does not intend to distinguish between components that differ in name but not function. 
     Matters of these example embodiments that are obvious to those of ordinary skill in the technical field to which these example embodiments pertain may not be described here in detail. 
       FIG.  1    is a perspective view of a delivery device  1  according to an example embodiment. The delivery device  1  is illustrated with a transparent cover for clarity and illustrates various components within the delivery device  1 .  FIG.  2    is an exploded view illustrating various components of the delivery device of  FIG.  1   . As shown, the device  1  may include: a reservoir  4  for storing insulin or other liquid medication to be injected; a pump  3  for pumping the medication out of the reservoir  4 ; and a power source  5 , which may comprise one or more batteries. An insertion mechanism  7  inserts an inserter needle with a catheter into a patient’s skin. 
     A pair of dose buttons  6  are disposed on a cover  2  for actuating a medication dose, including a basal and/or bolus dosing; and various components may be attached to a base  9  above via one or more fasteners  91 . The delivery device  1  also includes various fluid connector lines that transfer medication from the reservoir  4  to an infusion site. 
     Control electronics control the operations of the device  1  and may comprise communications capabilities for communication with one or more external devices including, but not limited to a remote controller, a personal computer, a smart phone, and a medication filling device, as discussed below. 
       FIG.  3    is a perspective view of an alternative design for a delivery device  1 A having a flexible reservoir  4 A, and illustrated without a cover. Such arrangement may further reduce the external dimensions of the delivery device  1 A, with the flexible reservoir  4 A filling voids within the device  1 A. The patch delivery device  1 A is illustrated with a conventional cannula insertion device  7 A that inserts the cannula, typically at an acute angle, less than 90 degrees, at the surface of a user’s skin. The delivery device  1 A further comprises: a power source  5 A in the form of batteries; a metering sub-system  41  that monitors the volume of insulin and includes a low volume detecting ability; control electronics  8 A for controlling the components of the device; and a reservoir fill port  43  for receiving a refill syringe to fill the reservoir  4 A. 
       FIG.  4    is a block diagram of a delivery device according to an example embodiment. The delivery device may include a microcontroller  60  configured to control a pumping mechanism  52 , wireless communication with an external device (e.g., via a communication circuit  54 ), and pump operations. The RF circuit may comprise a match circuit and one or more antennas, or may comprise another communication circuit, such as a Bluetooth communication circuit. The delivery device includes one or more bolus buttons  64  for manual delivery of medication in addition to any programmed delivery of medication. The pumping mechanism  52  comprises a reservoir  76  for storing a fluid medication (e.g., insulin) to be delivered via a cannula  68  to the patient wearing the device, and a pump  72  for controllably delivering designated amounts of medication from the reservoir through the cannula. The reservoir  76  can be filled via a septum  78  using a syringe. The device may include a manual insertion mechanism  66  for inserting the cannula  68  into a patient. However, the processor  60  can be configured to operate an optional drive circuit to automate operation of the insertion mechanism  66  to deploy the cannula  68  into the patient. The device may also include a fluid sensor  74  and/or a pressure sensor  70 . A light emitting diode (LED)  62  can be operated by the microcontroller  60  to turn on and off in one or more steady or flashing patterns to indicate one or more pump operations such as during reservoir priming. The device is powered by a battery and regulator as indicated at  58 . When initializing the device  1 , the bolus button  64  can be configured as a wake-up button that, when activated by the patient, causes the device to wake from a power conserving shelf mode. 
       FIG.  5    illustrates a filling device according to an example embodiment. The filling device  200  includes a base  209  onto which a medication delivery device, such as that of  FIG.  1    or  FIG.  3   , may be attached; and a vial attachment component  220 , which may be disposable. The vial attachment component  220  is configured to enable a vial of medication to be attached thereto. The base  209  comprises an electronic component  210 , a pump motor (not illustrated), and an empty vial sensor (not illustrated). The vial attachment component  220  comprises a piston pump, a fluid path, one or more needles, and a vial spike (not shown). 
       FIGS.  6 A- 6 C  illustrate a placement of a medication delivery device  1  into the base  209 , according to an example embodiment. As shown, the base  209  may comprise a lower case  211  and an upper lid  212 , wherein the lower case  211  may be configured to receive the delivery device therein, and the upper lid  212  may be hinged to the lower case  211  such that once the delivery device is placed within the lower case  211 , the upper lid  212  may be closed thereover. Each of the electronic component  210 , the pump motor (see, e.g.,  FIG.  7   ), and the empty vial sensor (see, e.g.,  FIGS.  8 - 9   ) may be disposed in the upper lid  212 , or in the lower case  211 . Alternately, instead of the upper lid  212  and lower case  211 , the base  209  may comprise a single unit, comprising each of the electronic component  210 , the pump motor, and the empty vial sensor, to which the delivery device is attachable. 
     The vial attachment component  220  comprises a vial spike (not shown) configured to pierce a seal on a vial when the vial is attached to the component  220 . The fluid path and vial spike provide communication between the vial and the base  209 . As shown in  FIG.  6 B , the vial attachment component  220  with the vial attached thereto can be mounted onto the base  209 . The vial attachment portion  220  may be latched to the base by means of a user pressing down on the vial, as shown in  FIG.  6 C . 
     Once the medication delivery device is attached to the base  209  and the vial and vial attachment component  220  is attached to the base  209 , a user may initiate filling of the device by pressing or otherwise activating a button  215  on the electronic component  210  of the base  209 . The electronic component  210  initiates the pumping mechanism to pump medication from the vial into the delivery device. The pumping mechanism may be any pump configured to operate both in forward and reverse modes, as would be understood by one of skill in the art. 
       FIG.  7    illustrates a pump mechanism  250  according to an example embodiment. The pump mechanism is based on a rotary piston pump and comprises a housing  255  having a thermoplastic over-mold seal  260  on an interior surface thereof. The piston  270  has an asymmetric cut  272  at a distal end  271  and a cam surface  276  at a proximal end  275 . As the piston is rotated and the cam surface  276  moves the piston  270  in and out of the pump housing  255 , the piston rotates and the rotation of the asymmetric cut  272  synchronizes with the opening and closing of the inlet  281  and outlet  282 . 
     As noted above, the pumping mechanism operates in both forward and reverse modes. Accordingly, when activated, for example by a user pressing a button  215  on the electronic component  210  of the base  209 , the pump pumps medication from the vial into the delivery device, thus breaking the reservoir bag seal in the delivery device. The pumping mechanism then pumps in reverse to remove any air bubble, prior to returning to the forward mode to fill the delivery device to a desired volume. 
     As noted above, the base  209  may include an empty vial detection sensor.  FIG.  8    is a diagram of an empty vial detection sensor  290  according to an example embodiment.  FIGS.  9 A and  9 B  illustrate an example means of operation of an empty vial detection sensor  290 . The sensor  290  includes a light source  291  and a sensor unit  295 . As illustrated in  FIGS.  9 A and  9 B , the light source  291  and sensor  295  are positioned with respect to each other such that light emitted from the light source  291 , which is transmitted through a vial containing liquid medication, is incident on the sensor  295  and is thereby detectable. When light emitted from the light source is transmitted through an empty vial containing air, the light is not incident on the sensor. Thus, a state of whether the vial contains liquid medication or not may be determined based on whether the sensor detects light from the light source  291  as incident thereon. Alternately, as would be understood by one of skill in the art, the light source  291  and sensor  295  may be disposed in respective positions such that light from the light source  291  is incident on the sensor  295  when transmitted through a vial containing liquid and is not incident on the sensor  295  when transmitted through an empty vial. The electronic component  210  may include one or more output elements, such as a light emitting diode (LED) or other light, a display, or a sound-emitting element. The sensor  295  is communicatively coupled to the electronic component  210 , such that, based on a signal received from the sensor, the electronic component can determine a state of whether the vial is empty, and can control the one or more output elements to signal to a user the state of the vial. 
     Returning to the delivery device itself, the device may be configured for continuous subcutaneous delivery of insulin at set and variable basal (24-hour period) rates and bolus (on-demand) doses for the management of patients with T2D, requiring insulin therapy. It is to be understood, however, that the medical device can be any on-body medical device (e.g., wearable infusion pump, continuous glucose meter) or body area network (BAN) medical device (e.g., handheld blood glucose meter, smart phone with medical condition management apps, or wireless controller for on-body device). 
     The device may be configured for a patient to wear for a period of three days (up to 84 hours), for example, and thus may have four main functions: delivering a user-set daily basal insulin rate; delivering a user-set bolus insulin amount; delivering manual bolus insulin dose(s); and generating system status and notifications. It is to be understood, however, that the medical device can be used to deliver any type of fluid and is not limited to insulin delivery or to T2D treatment regimens. 
     Upon initial application to a patient, the device must be programmed, for example with a daily basal insulin rate and a meal-time insulin amount for the particular patient. The device must also be controllable to enable a patient to control the delivery of an additional dose, if needed. 
       FIG.  10    illustrates a filling device  200  configured to communicate with and control a delivery device  1  according to an example embodiment. As discussed above with respect to FIG. D, the delivery device  1  may include one or more bolus buttons  6  for manual delivery of medication, a microcontroller  60 , and a communication circuit  54 . When initializing the delivery device  1 , for example powering-on the device to begin pairing with the filling device  200 , the bolus button 6 can be configured as a wake-up button that, when activated by a user, causes the delivery device  1  to wake from a power-conserving shelf mode. 
       FIG.  11    is a block diagram of a filling device according to an example embodiment. The filling device  200  includes a main processor and a communications processor  232 . The main processor is connected to user interface (UI) components, such as an LCD display with touch screen, one or more buttons, an LED indicator, and the like. The communications processor  232  is connected to radio frequency (RF) components  238  (e.g., an antenna and a match circuit) and is mainly responsible for the filling device’s wireless communication with the delivery device  1 . The two processors communicate with each other through a serial peripheral interface (SPI). The two processors can also interrupt each other through two interrupt pins, M_REQ_INT and S_REQ_INT. It is to be understood that the filling device can also be configured as a single processor device. A non-volatile memory (e.g., FLASH memory) is also provided in the filling device. 
     An LCD with a capacitive touch screen may serve as the visual interface for the user by rendering visual and graphical outputs to the user (e.g., system information, instructions, visual notices, user configurations, data outputs, etc.), and by providing a visual interface for the user to enter inputs (e.g., device operation inputs such as delivery device pairing and set up and dosing, and configuration parameters, and so on). The filling device display with capacitive touch screen detects (at least) single-touch gestures over its display area. For example, the touch screen may be configured for recognizing user tactile inputs (tap, swipe, and button press), allowing for navigation within UI screens and applications. The touch screen may aid in executing specific system functionalities (i.e. delivery device setup and pairing with the filling device, insulin dosing, providing user with dosing history, and delivery device deactivation and replacement with another delivery device, and so on) through specific user interactions. The filling device  200  can also include a button such as a device wake-up button that, when activated by the user, causes the filling device to wake from a power conserving sleep mode. The filling device can also have an LED to indicate low battery status (e.g., indicate low battery state when there are a predetermined number of hours or less of usage remaining). 
     The filling device  200  radio frequency (RF) interface with the delivery device  1  is, for example, based on a Bluetooth Low Energy or BLE-based communication protocol, although other wireless communication protocols can be used. The filing device  200  and the delivery device  1  may communicate wirelessly within a distance of up to 10 feet or approximately 3 meters, utilizing the ISM band from 2400 MHz to 2480 MHZ spectrum. The filling device  200  may be considered as the central device or master, and the delivery device  1  is the peripheral device or slave. Whenever the main processor wants to send information to the delivery device  1  or retrieve information from the delivery device  1 , it does so by interacting with the communications processor  232 , which in turn, communicates with the delivery device  1  across the BLE link via the respective RF circuits. 
     The software architecture of the filling device  200  may be configured to control initial setup of the delivery device  1 , when initially paired thereto. 
     The components of the illustrative devices, systems and methods employed in accordance with the illustrated embodiments described herein can be implemented, at least in part, in digital electronic circuitry, analog electronic circuitry, or in computer hardware, firmware, software, or a combination thereof. These components can be implemented, for example, as a computer program product such as a computer program, program code or computer instructions tangibly embodied in an information carrier, or in a machine-readable storage device, for execution by, or to control the operation of, data processing apparatus such as a programmable processor, a computer, or multiple computers. 
     A computer program can be written in any form of programming language, including compiled or interpreted languages, and it can be deployed in any form, including as a stand-alone program or as a module, component, subroutine, or other unit suitable for use in a computing environment. A computer program can be deployed to be executed on one computer or other device or on multiple device at one site or distributed across multiple sites and interconnected by a communication network. Also, functional programs, codes, and code segments for accomplishing features described herein can be easily developed by programmers skilled in the art. Method steps associated with the example embodiments can be performed by one or more programmable processors executing a computer program, code or instructions to perform functions (e.g., by operating on input data and/or generating an output). Method steps can also be performed by, and apparatuses described herein can be implemented as, special purpose logic circuitry, e.g., a field programmable gate array (FPGA) or an application-specific integrated circuit (ASIC), for example. 
     The various illustrative logical blocks, modules, and circuits described in connection with the embodiments described herein may be implemented or performed with a general purpose processor, a digital signal processor (DSP), an ASIC, a FPGA or other programmable logic device, discrete gate or transistor logic, discrete hardware components, or any combination thereof designed to perform the functions described herein. A general purpose processor may be a microprocessor, but in the alternative, the processor may be any conventional processor, controller, microcontroller, or state machine. A processor may also be implemented as a combination of computing devices, e.g., a combination of a DSP and a microprocessor, a plurality of microprocessors, one or more microprocessors in conjunction with a DSP core, or any other such configuration. 
     Processors suitable for the execution of a computer program include, by way of example, both general and special purpose microprocessors, and any one or more processors of any kind of digital computer. Generally, a processor will receive instructions and data from a read-only memory or a random access memory or both. The essential elements of a computer are a processor for executing instructions and one or more memory devices for storing instructions and data. Generally, a computer will also include, or be operatively coupled to receive data from or transfer data to, or both, one or more mass storage devices for storing data, e.g., magnetic, magneto-optical disks, or optical disks. Information carriers suitable for embodying computer program instructions and data include all forms of non-volatile memory, including by way of example, semiconductor memory devices, e.g., electrically programmable read-only memory (ROM) (EPROM), electrically erasable programmable ROM (EEPROM), flash memory devices, and data storage disks (e.g., magnetic disks, internal hard disks, or removable disks, magneto-optical disks, and CD-ROM and DVD-ROM disks). The processor and the memory can be supplemented by, or incorporated in special purpose logic circuitry. 
     Computer-readable non-transitory media includes all types of computer readable media, including magnetic storage media, optical storage media, flash media and solid state storage media. It should be understood that software can be installed in and sold with a central processing unit (CPU) device. Alternately, the software can be obtained and loaded into the CPU device, including obtaining the software through physical medium or distribution system, including, for example, from a server owned by the software creator or from a server not owned but used by the software creator. The software can be stored on a server for distribution over the Internet, for example. 
     It may be understood that the example embodiments described herein may be considered in a descriptive sense only and not for purposes of limitation. Descriptions of features or aspects within each example embodiment may be considered as available for other similar features or aspects in other example embodiments. 
     While exemplary embodiments have been described with reference to the figures, it will be understood by those of ordinary skill in the art that various changes in form and details may be made therein without departing from the spirit and scope as defined by the following claims.