Smart injector and smart cap

Abstract

The present application relates to a smart syringe and a smart cap. A two-piece cap (100) for an injection pen (106) is provided. The cap includes a static portion (102) that remains on the pen syringe (106) and a removable portion (104). The static portion (102) includes a dose sensor (126) for sensing movement of a plunger (118) within a reservoir (114) of the pen syringe (106). A delivered dose is calculated based on the detected plunger movement.

Description

[0001] CROSS REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to U.S. Provisional Application 62 / 894,031 filed in the U.S. Patent and Trademark Office on August 30, 2019, the disclosure of which is incorporated herein in its entirety by this reference. BACKGROUND

[0003] 1. FIELD

[0004] Apparatuses and methods consistent with exemplary embodiments relate to syringes for transferring (i.e., injecting or withdrawing) fluids, and more particularly to syringes that include a smart plunger cap that senses and provides information about drug delivery.

[0005] 2. DESCRIPTION OF RELATED ART

[0006] Most syringes in current use are of the disposable or single-use type. A typical disposable syringe 100, shown in FIG. 1, is made primarily of plastic and has several key components. The largest and containing the most material is the plastic barrel 10. The scale print 12 on the barrel 10 is a critical and expensive assembly step that the user needs to ensure proper dosing. Inside the barrel 10 is a rubber stopper 20, which is used to form an airtight seal and to move liquid medication or other fluids into and out of the barrel. A plastic plunger rod 25 engages the rubber stopper 20 to move it back and forth under the user’s control. A metal needle 30 or cannula is usually attached to the distal end of the barrel to allow fluid to be injected into or removed from the body, although this is not always the case. For example, a syringe with a male Luer connector at its distal end can be connected to a female Luer connector on a catheter or IV line in order to inject or withdraw liquid without using a needle or cannula.

[0007] In hospital and care settings, large numbers of syringes can be used in relatively short periods of time and for the management of certain conditions by patients. For example, in the management of diabetes, disposable plastic syringes are commonly used to administer liquid insulin to users several times a day. Such disposable syringes typically have a clear polymeric barrel with printed scale numbers that the user consults to determine the proper dose of insulin from a vial, and a fine gauge metal needle (typically about 6 to 12 mm in length) that injects the dose into the skin with minimal discomfort to the user. The needle can use a Luer-Lok TMor luer slip connectors are removably connected to the barrel, or they can be permanently attached or "staked" to the barrel during manufacture of the syringe. Insulin syringes typically have a capacity of 1 ml or less (commonly having 0.3 ml, 0.5 ml, and 1.0 ml barrel sizes), and the scale markings on the barrel represent units of a particular type of insulin (e.g., U-100 or U-500 insulin). Insulin syringes can also be provided with safety features to prevent reuse of the syringe, shield the used needle, or both. Because insulin syringes are used only once, and several of them are typically needed by a user each day, they are commonly sold in boxes or bags containing multiple syringes.

[0008] For the type of insulin syringe described above, there are no durable (reusable) components. The entire syringe and needle are discarded after a single use, and no components are reused. While disposal of single-use syringes is advantageous in ensuring sterility and preventing the spread of blood-borne diseases, the expense of providing all of the required syringe components and assembly steps for a single use is higher than can be desirable. Discarded syringes also create a disposal burden in hospitals and other medical facilities, as they cannot be mixed with other types of medical waste, but must be placed in special sharps disposal containers. Thus, there is a need for a syringe in which the expense and disposal burden associated with single use are reduced, while maintaining the sanitary advantages of a disposable syringe.

[0009] Effective administration of certain types of medication injections, particularly in the case of insulin use by diabetic patients, requires that a record of all administered doses be kept. While training is provided for home injection patients, most patients still find it challenging to correctly follow these instructions day after day. Additionally, the only means for obtaining a record of injections and injection doses is by manually writing it down. Health care personnel can record dose-related information in a clinical setting, but there is significant overhead associated with capturing this information. It is also difficult to measure and record certain injection times and doses. Certain patients can also find it difficult to draw very specific amounts of medication into a syringe and / or to determine a specific amount of medication that has been injected due to difficulty reading scale markings on the barrel of the syringe or difficulty following appropriate instructions.

[0010] There is a need for an improved syringe that can provide a user with more accurate information about delivered doses and compliance with a prescribed medication dosage regimen. SUMMARY

[0011] The example embodiments can address at least the problems and / or disadvantages described above and / or other disadvantages not described above. Also, the example embodiments need not overcome the disadvantages described above, and can not overcome any of the problems described above.

[0012] One or more example embodiments can provide a smart syringe having a disposable body and a reusable smart cap configured to sense and output medication delivery information.

[0013] According to an aspect of an example embodiment, there is provided a smart syringe comprising: a barrel; a stopper; a plunger rod connected to the stopper such that movement of the plunger rod causes the stopper to displace within the barrel; and a smart cap configured to be connected to the plunger rod. The smart cap can comprise: a sensor configured to sense movement of the plunger rod, an indicator comprising one of a visual indicator and an audible indicator, a communication module, and a power source.

[0014] The communication module can comprise a Bluetooth chip.

[0015] The plunger rod can comprise a first end connected to the stopper and a second end opposite the first end, the second end having threads thereon; and the smart cap is configured to be threadably connected to the second end of the plunger rod.

[0016] The barrel, the stopper, and the plunger rod can be disposable.

[0017] The smart cap can further comprise one or more of: an accelerometer configured to sense when a needle attached to the barrel has pierced a user's skin; a timer configured to measure a time elapsed after the needle has pierced the user's skin. The microcontroller can be configured to control the indicator to output an indication of a predetermined time that has elapsed after the needle has pierced the user's skin.

[0018] According to an aspect of another example embodiment, there is provided a smart cap comprising: a body configured to be attached to a plunger rod of a syringe; a sensor configured to sense movement of the plunger rod; an indicator comprising one of a visual indicator and an audible indicator; a communication module; and a power source.

[0019] The communication module can comprise a Bluetooth chip.

[0020] The smart cap can be configured to be threadably connected to an end of the plunger rod.

[0021] The smart cap can further comprise an accelerometer.

[0022] According to an aspect of another example embodiment, there is provided a method of obtaining injection information, the method comprising: powering up a smart cap by attaching the smart cap to a plunger rod and barrel of a syringe; sensing movement of the plunger rod via a sensor disposed in the smart cap; calculating a dose administered to a patient using data of the movement of the plunger rod output by the sensor; and storing data of the dose administered to the patient.

[0023] The method can further comprise: transmitting data of the movement of the plunger rod output by the sensor from the smart cap to an external device; wherein the calculating the dose and storing data is performed by the external device.

[0024] The method can further comprise: a microcontroller in the smart cap determining an injection time of the dose based on data received from an accelerometer in the smart cap; a timer in the smart cap determining a time elapsed after the injection time; and an indicator outputting an indication to a user when a predetermined amount of time has elapsed after the injection time.

[0025] The method can further comprise: obtaining an injection time of the dose; and storing data of the injection time of the dose.

[0026] Obtaining the injection time can comprise an accelerometer in the smart cap sensing injection of the dose, and a microcontroller in the smart cap obtaining the injection time based on data output from the accelerometer. BRIEF DESCRIPTION OF DRAWINGS

[0027] The above and / or other aspects will become apparent and more readily

[0028] FIG. 1 illustrates a disposable syringe according to the prior art;

[0029] Figure 2A and 2B illustrates a smart syringe according to an example embodiment;

[0030] Figure 3 illustrates a smart syringe system according to an example embodiment;

[0031] Figure 4 is a schematic diagram of electronic components of a smart cap according to an example embodiment; and

[0032] Figure 5 is a flowchart of operations according to an example embodiment. DETAILED DESCRIPTION

[0033] Reference will now be made in detail to the example embodiments, examples of which are illustrated in the accompanying drawings, wherein like reference numerals refer to like elements throughout. In this regard, the example embodiments can have different forms and the disclosure makes no warranty that the

[0034] It will be understood that the terms "comprises" 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.

[0035] It will be understood that, although the terms "first," "second," "third," etc. can be used herein to describe various elements, components, regions, layers and / or sections, these elements, components, regions, layers and / or sections should 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.

[0036] 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 the list of elements, modify the entire list of elements and do not modify the individual elements of the list. Also, the term "unit," "member" and "module" described in the specification refer to an element for performing at least one function or operation, and can be implemented in hardware, software, or a combination of hardware and software.

[0037] 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.

[0038] Aspects of the example embodiments that would be obvious to those of ordinary skill in the art pertaining to the technology to which the example embodiments belong can not be described in detail.

[0039] As discussed above with reference to FIG. 1, the prior art disposable syringe 100 includes a plastic barrel 10 having scale printing 12 thereon and a needle 30 attached thereto. A rubber stopper 20 disposed within the barrel 10 is connected to a plunger rod 25. Pressure on a distal end 25a of the plunger rod 25 exerts pressure on the fluid within the barrel 10, allowing the fluid to be injected into the body.

[0040] Figure 2A And 2BAn intelligent syringe 200 according to exemplary embodiments is shown. The intelligent syringe 200 includes a barrel 210 having a stopper 220 therein and a needle 230 connected or connectable to the barrel. The needle 230 can be detachably connected to the barrel 210 or can be permanently connected during the manufacturing process. The barrel 210 can have scale printing 212 printed thereon or can omit the scale printing. A plunger rod 225 is connected to the stopper 220. The intelligent syringe 200 also includes an intelligent cap 250 and a plunger end cap 257. For sterility, at least the barrel 210, needle 230, stopper 220, and plunger rod 225 can be disposable. The intelligent cap 250 and plunger end cap 257 are reusable. For use, the intelligent cap 250 / plunger end cap 257 combination can be threaded onto the threaded end 226 of the plunger rod 225. When assembled together, the plunger rod 225 engages sensors within the intelligent cap 250, as described below. Attachment of the intelligent cap 250 to the barrel 210 and / or plunger rod 225 can engage a micro switch 466 that allows power from a power source 468 to be supplied to other electronic components of the intelligent cap 250, as discussed below with respect to Figure 4 As discussed below in further detail, the power source 468 also provides power to a Bluetooth module, which upon initial power up can be configured to drive a visual indicator 256 / 460 and / or an audible indicator 462 to indicate a first state.

[0041] The intelligent cap can include a mechanism such as a dialing mechanism (not shown) that allows a dose to be drawn into the syringe from a vial. Such a dialing mechanism can enable the syringe 200 to be converted into a device that functions and is used in the manner of a pen-injector. With such a dialing mechanism, when the plunger is depressed via the end cap 257, a dose is delivered and the mechanism is reset. Alternatively, in one or more example embodiments, the dialing mechanism can be omitted.

[0042] When the injection is complete, the intelligent cap 250 and end cap 257 can be disconnected from the plunger rod 225 and barrel 210, and the plunger rod 225, barrel 210, stopper 220, and needle 230 can be discarded, while the intelligent cap 250 and end cap 257 are saved for reuse.

[0043] The intelligent cap 250 can include a sensor 446 to determine the position of the plunger rod 225 during an injection. For example, the sensor 446 can convert linear motion of the plunger rod 225 to rotational motion of a recording device via a rotary encoder, such as an optical or mechanical rotary encoder, which converts linear motion to a rotational angle and vice versa, as will be appreciated by those skilled in the art.

[0044] An accelerometer 456 can also be included to determine when the skin has been pierced by the needle 230, thereby enabling determination of the position of the plunger rod 225 at the time of injection. A timer and audible indicator 462 and / or visual indicator 256 / 460 can be included to help the patient allow sufficient time for the injection, and / or to provide an indication of one or more states. Typically, the user should not inject the dose and immediately pull the needle out of the skin, as there is a delay period between injection and the dose being properly placed so that it does not leak back to the surface of the skin. The injection time can be detected via the accelerometer 456, and the timer 457 can alert the user via the audible indicator 462 and / or visual indicator 256 / 460 when to withdraw the needle. The visual indicator can include one or more lights, such as LEDs, a digital counter, and / or another type of display screen. The microcontroller can control the visual indicator to display one or more of the amount of the dose, the time of day, the timer, and the number of doses.

[0045] Clearly, only when the size of the cartridge 210 is known can the particular dose be determined from the position of the plunger rod 225. Thus, the smart cap 250 can be configured to attach only to a single size of cartridge 210. Alternatively, as will be appreciated by those skilled in the art, the smart cap 250 and / or the connected external device 350 (discussed below) can learn the size of the cartridge by any of a variety of ways.

[0046] Figure 3 A smart injector system 300 is shown that includes the smart cap 250 and another connected external device 350. The external device 350 can be, for example, a smartphone as shown, or a laptop computer, tablet computer, personal computer, or other processing device. The smart cap 250 and the external device 350 can be connected wirelessly, such as by a Bluetooth connection, or via a wired connection. The two communication platforms can have different combinations of hardware and software. The data transfer between the devices can differ depending on when and how the data transfer occurs between the smart cap and the external device. For example, the smart cap 250 can transmit data about the status of the drug delivery (e.g., completed or not completed) or other delivery information (e.g., rate, timing, etc.) in real time (i.e., during the injection) or at any time after the injection, such as when the previously disconnected devices are eventually paired or otherwise connected. The communication connection can be wired or wireless. Different wireless connection methods include, but are not limited to, Bluetooth, WiFi, and near field communication (NFC), which can affect the device pairing, if needed, and require proximity of the devices. As will be appreciated by those skilled in the art, the appropriate proximity of the devices to each other depends on the connection method used. The timing of the data transfer can depend at least in part on whether the two communication platforms and / or at least the smart cap have time-keeping capabilities.

[0047] According to aspects of example embodiments, the external device can be a smart phone 350 that is provided with a delivery information application to connect to and cooperate with the smart cap 250. The user can pair the smart phone with the smart cap using, for example, standard Bluetooth technology methods in order to synchronize.

[0048] With continued reference to Figure 3 For example, data synchronization between the smart cap 250 and the smart phone can occur at each injection to obtain delivery data. The smart phone 350 advantageously can provide time logging capability (e.g., data provided during an injection or immediately after an injection is stored in a memory device in the smart phone 350 along with a time stamp using a clock in the smart phone). The Bluetooth connection between the smart phone 350 and the delivery device allows the smart cap 250 to be located within about 10 meters of the smart phone 350 and operable to transfer delivery data to the smart phone. Pairing with the smart phone 350 for data transfer as well as use of the memory and time logging features of the smart phone allows the electronic components in the smart cap 250 to be minimized for reduced complexity and reduced manufacturing cost.

[0049] Figure 4 is a schematic diagram of the electronic components 400 within the smart cap 250. According to one or more example embodiments, the smart cap 250 can also perform other condition monitoring and information reporting functions. The components of the smart cap 250 include a microcontroller 450 with an internal real time clock, sensors 446, a memory 452 for storing programs and data used by the microcontroller 450, an accelerometer 456 for measuring the amount of motion or disturbance that the plunger rod 225 can be subjected to, a communication module 458 for communicating with a connected device, and a micro switch 466 that senses the initial connection of the plunger rod 225 to the smart cap 250 and the initial connection of the smart cap 250 to the barrel of the syringe 100. The communication module can include a wired connector (e.g., a USB or mini-USB interface) or a wireless interface to communicate, for example, via Bluetooth or WiFi or NFC technology. For example, the smart cap 250 can include a Bluetooth chip, such as a Bluetooth Low Energy LE chip such as the TI CC2541, with an on-board processor and memory for synchronization and other Bluetooth operations.

[0050] The smart cap 250 can additionally include one or more visual indicators 256 / 460, such as light emitting diodes (LEDs) of different colors, one or more audible and / or tactile indicators 462, such as a pager, a buzzer, a speaker, or a vibration device, and one or more buttons 464. A power source 468, such as in the form of replaceable or rechargeable direct current (DC) batteries and appropriate voltage regulation circuitry, powers the microcontroller 450 and Figure 4 any other components of the smart cap 250 that require power.

[0051] Figure 5is a flowchart of operations performed by the user and by the smart cap according to example embodiments. As described above, attachment of the smart cap 250 to the plunger rod 225 and barrel 210 (block 501) causes the microswitch 466 to close and power from the power source 468 is supplied to the smart cap 250. One or both of the visual indicator 256 / 460 and audible indicator 462 can indicate that the smart cap 250 is powered on, but not yet connected to an external device (block 502). The microcontroller 450 is configured such that power on of the smart cap 250 powers the Bluetooth or other connection module 458 to begin advertising for pairing with the external device 350 (block 503). If no pairing occurs, the smart cap 250 is powered off (block 504).

[0052] If pairing between the connection module 48 of the smart cap 250 and the external device 350 is successful, one or both of the visual indicator 256 / 460 and audible indicator 462 can indicate that the device is connected (block 505). When the user pulls back on the plunger rod 225 to obtain a dose, i.e., to fill the barrel 210 of the syringe 200, the sensor 446 senses this motion of the plunger rod 225 and one or more of the indicators 256 / 460 and / or 462 provide a fill indication to the user (block 506). The user can then inject the dose, and upon detection of the dose injection by the sensor 446 and accelerometer 456, one or more of the indicators can provide an injection indication to the user (block 507). The timer 457 can also transmit the injection time to the microcontroller 450, and the sensor 446 can sense motion of the plunger rod 225 during injection and transmit that information to the microcontroller 450. Information from the timer 457 and / or sensor can be recorded in the memory 452 and transmitted to the external device 350 (block 508). During and / or after injection, the external device 350 can be configured by an application to process the received data to determine, for example, injection time, flow rate over time, and total dose, and store that information (block 509). The microcontroller 450 of the smart cap 250 or the external device 350 can determine the time and volume of the dose and the dose rate over time, for example, which can be stored in the external device 350. After injection is complete, the user detaches the smart cap 250 from the plunger rod 225 and barrel 210 of the syringe (block 510), and the smart cap 250 is powered off (block 511).

[0053] With further reference to one or more indicators 256 / 460 and 462, the visual indicator 256 / 460 can include one or more LEDs to show one or more states. The audible indicator can output a sound, such as a tone or a pre-recorded voice, for example, to indicate one or more states. For example, one or both of the one or more indicators 256 / 460 and 462 can indicate one or more of the following states: (1) the smart cap 250 is powered and announced (e.g., both operations can occur simultaneously, and if a time limit expires, the device can be powered off); (2) the smart cap 250 is paired with the external device 350; (3) insulin or other medication is drawn into the syringe 200; (4) an injection is in progress; and / or (5) the user can remove the needle from the injection site. This last indication can provide an additional benefit to the user. As noted above, a typical syringe user is instructed to deliver the prescribed dose, then count to 10, which provides a very subjective and potentially erroneous indication of delivery. In contrast, the smart cap 250 is configured to sense when an injection is in progress, and to operate a countdown timer that reminds the user when it is safe to remove the needle from the injection site. A single LED or a single tone can be used to indicate multiple states, such as all five of the previously mentioned states. For example, an RGB LED can indicate different colors that can correspond to device states, and the LED can flash and / or a tone can sound in different patterns, depending on the injection state as well.

[0054] As noted above, according to an aspect of the example embodiments, data can be stored in the memory 452 of the smart cap 250, as well as transmitted to the external device 350. Thus, data can be stored in the smart cap 250, and transmitted to the external device 350 at a later time than during real-time injection and sensing operations. Thus, if the smart cap 250 and the external device 350 are not paired at the time of data capture, the data is not lost.

[0055] It is to be understood that the example embodiments described herein can be considered in a descriptive sense only and not for purposes of limitation. Descriptions of features or aspects within each example embodiment should be considered as available for other similar features or aspects in other example embodiments.

[0056] While the example 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 can be made therein without departing from the spirit and scope as defined by the following claims.

Claims

1. A smart syringe comprising: a barrel; a stopper; a plunger rod connected to the stopper such that movement of the plunger rod causes the stopper to displace within the barrel; and a smart cap configured to be connected to the plunger rod, the smart cap comprising: a sensor configured to sense movement of the plunger rod, an accelerometer configured to sense when a needle attached to the barrel has pierced a user's skin, an indicator comprising one of a visual indicator and an audible indicator, a communication module, a power source, a timer configured to measure time elapsed after the needle has pierced the user's skin, and a microcontroller configured to control the indicator to output an indication of a status of an injection performed by the syringe based on one or more of: a predetermined time that has elapsed after the needle has pierced a user's skin, movement of the plunger rod, and data from the accelerometer. The communication module comprises a Bluetooth chip.

2. The smart syringe of claim 1, wherein, 3. The smart syringe of claim 1, wherein: the plunger rod comprises a first end connected to the stopper and a second end opposite the first end, the second end having threads thereon; and the smart cap is configured to be threadably connected to the second end of the plunger rod. The barrel, the stopper, and the plunger rod are disposable.

4. The smart syringe of claim 1, wherein, 5. A smart cap comprising: a body configured to be attached to a plunger rod of a syringe; a sensor configured to sense movement of the plunger rod; an accelerometer configured to sense when a needle attached to a barrel of the syringe has pierced a user's skin; an indicator comprising one of a visual indicator and an audible indicator; a communication module; a power source, a timer configured to measure time elapsed after the needle has pierced the user's skin, and a microcontroller configured to control the indicator to output an indication of a status of an injection performed by the syringe based on one or more of: a predetermined time that has elapsed after the needle has pierced a user's skin, movement of the plunger rod, and data from the accelerometer. The communication module comprises a Bluetooth chip.

6. The smart cap of claim 5, wherein, The smart cap is configured to be threadably connected to an end of the plunger rod.

7. The smart cap of claim 5, wherein, 8. A method of obtaining injection information, the method comprising: powering up a smart cap by attaching the smart cap to a plunger rod and a barrel of a syringe; sensing movement of the plunger rod via a sensor disposed in the smart cap; determining, by a microcontroller in the smart cap, a time when a needle attached to the barrel has pierced a user's skin based on data received from an accelerometer in the smart cap; determining, by a timer in the smart cap, a time elapsed after the needle has pierced the user's skin; and ​ ​ The indicator outputs to the user an indication of the status of an injection performed by the syringe, the indication being based on one or more of: a predetermined time that has elapsed since the needle has pierced the skin of the user, and movement of the plunger rod.

9. The method of claim 8, further comprising: calculating a dose administered to the user using data of movement of the plunger rod output by the sensor; and storing data of the dose administered to the user.

10. The method of claim 9, further comprising: transmitting data of movement of the plunger rod output by the sensor from the smart cap to an external device; wherein calculating the dose and storing data is performed by the external device.

11. The method of claim 9, further comprising: obtaining an injection time of the dose; and storing data of the injection time of the dose.

12. The method of claim 11, wherein, Obtaining the injection time comprises sensing injection of the dose by an accelerometer in the smart cap.

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