Smart syringe with dose capture and smartphone app

Abstract

A smart syringe system and method are provided. The system includes a smart syringe and an external device. The syringe acquires data of the dose administered to the patient and wirelessly transmits the data to the external device. In turn, the external device acquires the data via an image of the syringe. The external device may execute an application configured to process the data and display the dose information.

Description

[Technical Field]

[0001] The present invention relates to a dose-capturing smart syringe and smartphone app. [Background technology]

[0002] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Application No. 63 / 017,347, filed with the U.S. Patent and Trademark Office on April 29, 2020, the disclosure of which is incorporated herein by reference in its entirety.

[0003] 1. Field Apparatus and methods consistent with one embodiment relate to syringes for transferring (i.e., injecting or drawing) liquids, and more particularly to smart syringes that can sense and provide volume and dosage fill information and transmit the information to a smartphone application (app).

[0004] 2. Description of Related Technology Lack of medication adherence is a significant problem worldwide, especially in diabetes care. Approximately 50 percent of all patients do not take their medications as prescribed. Lack of medication adherence is one of the direct causes of hundreds of thousands of deaths and billions of dollars in unnecessary medical and related costs.

[0005] Smartphone apps are currently in use that use photographs of prescription labels to help patients reorder prescribed medications when supplies are low, but these apps do not allow patients to directly view the medication or dosage before taking it, and they do not consider their specific use with syringes or injector pens.

[0006] There are other smartphone apps that assist users by recording medical events such as injections, and smart injection devices that can assist users by automatically recording dialed amounts of medication delivered and / or the amount of medication delivered.

[0007] Nevertheless, there remains a continuing need for methods and devices that assist users (e.g., patients, their caregivers, their healthcare providers, and other stakeholders in disease management, such as payers / insurance companies, pharmacies and medical product suppliers and distributors) in obtaining and using information related to disease management events to avoid medical errors, such as medication delivery errors, and to improve related processes, such as refilling medical supplies, tracking compliance with disease management protocols or regimens, and sharing information among disease management stakeholders for optimal patient treatment care plans, billing, and insurance coverage intent.

[0008] A typical syringe 100, illustrated in FIG. 1, is made primarily of plastic and has several key components, including a barrel 10, a stopper 20, a plunger rod 25, and a needle 30. Gradient printing 12 on the barrel 10 is used to allow the user to administer the proper dose. Inside the barrel 10 is a rubber stopper 20, which provides a tight seal and is used to transfer liquid medication or other liquids into and out of the barrel. The plunger rod 25 interacts with the rubber stopper 20, moving 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 for the injection and removal of liquids from the body, although this is not always the case. For example, a syringe with a male Luer connector on its distal end can be attached to a female Luer connector on a catheter or IV line to inject or withdraw fluids without the use of a needle or cannula.

[0009] Many syringes may be used relatively short-term by patients in hospital and medical settings and for administration of certain conditions. The needle may be removably connected to the barrel using a Luer-Lok™ or Luer-Slip connection, or needle may be permanently attached or "staked" to the barrel during manufacture of the syringe. 。

[0010] Effective administration of certain drug injections, particularly insulin used by diabetics, requires keeping records of all administered doses. While education is provided to patients who inject at home, most patients still find it difficult to properly follow instructions on a daily basis. Furthermore, the only means of obtaining a record of injections and the doses administered is by manually writing them down. While healthcare professionals can record dosage-related information in healthcare settings, the overhead associated with capturing this information is significant. Measuring and recording the time and dosage of an injection is similarly difficult. Some patients may find it similarly difficult to draw the exact amount of medication into the syringe and / or determine the exact amount of medication injected due to difficulty reading the graduations on the syringe barrel or following instructions properly.

[0011] There is a need for improved syringes that can provide users with more accurate information about the dose delivered and compliance with prescribed drug dosage regimens. Summary of the Invention

[0012] An example embodiment may address at least the problems and / or disadvantages described above, as well as other disadvantages not described above, and is not required to overcome the disadvantages described above, and may not overcome any of the problems described above.

[0013] According to an aspect of an example embodiment, a smart syringe system includes a syringe and an external device. The syringe includes a body having a first pattern printed thereon and a plunger having a second pattern printed thereon such that a relative position of the plunger relative to the body can be determined based on an optical comparison of the relative positions of the first pattern and the second pattern. The device includes an image capture device and a processor configured to analyze the image capture device to thereby determine a fill level of the syringe.

[0014] The first pattern may be a scale printed on the barrel of the syringe body.

[0015] The second pattern is the plan Ja - Vertical axis It may also be a series of triangles extending along a length parallel to the

[0016] The device may also include a memory for storing software instructions, and the processor may be configured to execute the software instructions to execute an application configured to cause the processor to display information regarding the fill level of the syringe.

[0017] According to one aspect of another embodiment, a smart syringe system includes a syringe and a device external to the syringe, the syringe including sensing means for sensing a dose administered to a patient and first communication means for transmitting data about the dose, the external device including second communication means for receiving data about the dose and a display for displaying information about the dose.

[0018] The sensing means may be one of a linear encoder and a rotary encoder.

[0019] The sensing means may be a sleeve disposed around the barrel of the syringe, the sleeve including a linear encoder.

[0020] The first and second communication means may be a Near Field Communication (NFC) transmitter and an NFC receiver, respectively.

[0021] According to one aspect of another embodiment, a syringe system method includes the steps of the syringe transmitting data about the dose administered to the patient to an external device, the external device receiving the data, a processor of the device executing software instructions to thereby analyze the data, and the external device displaying information about the dose.

[0022] The syringe may transmit data via NFC and the external device may receive data via NFC.

[0023] The syringe may also acquire data via one of a linear encoder and a rotary encoder. [Brief explanation of the drawings]

[0024] These and / or other exemplary aspects and advantages will become apparent and more readily appreciated from the following description of exemplary embodiments when considered in conjunction with the accompanying drawings.

[0025] [Figure 1] 1 illustrates a disposable syringe according to the related art. [Figure 2A] 1 illustrates an exemplary smart syringe with a linear encoder, according to an example embodiment. [Figure 2B] 1 illustrates an exemplary smart syringe with a linear encoder, according to an example embodiment. [Figure 2C] 1 illustrates an exemplary smart syringe with a linear encoder, according to an example embodiment. [Figure 3A] 1 illustrates an exemplary smart syringe with a sleeve including a linear encoder, according to an example embodiment. [Figure 3B]1 illustrates an exemplary smart syringe with a sleeve including a linear encoder, according to an example embodiment. [Figure 3C] 1 illustrates an exemplary smart syringe with a sleeve including a linear encoder, according to an example embodiment. [Figure 4A] 1 illustrates an exemplary smart syringe with a rotary encoder, according to an example embodiment. [Figure 4B] 1 illustrates an exemplary smart syringe with a rotary encoder, according to an example embodiment. [Figure 4C] 1 illustrates an exemplary smart syringe with a rotary encoder, according to an example embodiment. [Figure 5A] 1 illustrates an exemplary smart syringe with a plunger provided with a pattern thereon, according to an example embodiment. [Figure 5B] 1 illustrates an exemplary smart syringe with a plunger provided with a pattern thereon, according to an example embodiment. [Figure 6] 1 illustrates an electrical circuit of a rotary encoder according to an example embodiment. [Figure 7] 1 illustrates a smart syringe tapping an external device, according to an example embodiment. [Figure 8] 1 illustrates a system including a smart syringe and an external device, according to an example embodiment. [Figure 9A] 1 illustrates information that an app may cause to be displayed on an external device, according to an example embodiment. [Figure 9B] 1 illustrates information that an app may cause to be displayed on an external device, according to an example embodiment. [Figure 9C] 1 illustrates information that an app may cause to be displayed on an external device, according to an example embodiment. [Figure 9D] 1 illustrates information that an app may cause to be displayed on an external device, according to an example embodiment. [Figure 9E] 1 illustrates information that an app may cause to be displayed on an external device, according to an example embodiment. [Figure 10] 1 is a flowchart of the operation of a smart syringe and an external device, according to an example embodiment. DETAILED DESCRIPTION OF THE INVENTION

[0026] Reference will now be made in detail to the exemplary embodiment illustrated in the accompanying drawings, wherein like reference numerals refer to like elements throughout the specification, in that the exemplary embodiment may have different forms and should not be construed as limited to the description set forth herein.

[0027] It will be understood that the terms "comprises," "including," "comprises," and / or "comprising," when used within this specification, specify the presence of stated features, integers, steps, operations, elements, and / or components, but do not exclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and / or groups thereof.

[0028] It is further understood that, although terms such as "first," "second," and "third" 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 to these terms. These terms are merely used to distinguish one element, component, region, layer, or section from another element, component, region, layer, or section.

[0029] As used herein, the term "and / or" includes any and all combinations of one or more of the associated listed items. Phrases such as "at least one of," when preceding listed elements, modify the listed elements as a whole, not the listed elements individually. Furthermore, terms such as "unit," "-er," and "module" described herein refer to an element that performs at least one function or operation, and may be implemented in hardware, software, or a combination of hardware and software.

[0030] Various terms are used to refer to particular system components. Different companies may refer to components by different names. This document does not intend to distinguish between components that differ in name but not function.

[0031] Contents of these example embodiments that are obvious to those skilled in the art to which these example embodiments pertain may not be described in detail herein.

[0032] 1, a related art disposable syringe 100 includes a plastic barrel 10 having graduations 12 printed thereon and a needle 30 attached thereto. Disposed within the barrel 10 is a rubber stopper 20 attached to a plunger rod 25. Pressure on the distal end 25a of the plunger rod 25 applies pressure to the liquid within the barrel 10, allowing the liquid to be injected into the body.

[0033] According to one example embodiment, the smart syringe comprises means for wirelessly communicating with an external device and means for sensing one or more injected dosages and one or more injected fill levels.

[0034] The means of transmission may be one or more of capacitive, resistive, inductive, antenna attenuated, color coded, and digitally encoded.

[0035] According to one embodiment, the sensing means is disposed on the outside of the syringe barrel or on the syringe plunger shaft. And The syringe may include a resistive thin film that is attached to the sliding contacts. The sliding contacts may be mounted such that a resistance changes between them when the plunger is pulled to draw the medication into the syringe or when the plunger is depressed to inject the medication into the user. An electrical circuit, which may be located under the finger tab of the syringe or on the thumb rest of the syringe, may monitor the resistance between the sliding contacts and transmit this information to an external device.

[0036] According to another exemplary embodiment, the means for sensing comprises a linear encoder, for example a Hall effect linear encoder.

[0037] 2A, 2B, and 2C illustrate an exemplary smart syringe 200 with a linear encoder 250. The smart syringe 200 includes a digitally encoded plunger 220, which may be completely disposable. As shown in FIGS. 2B and 2C, the plunger 220 includes a mechanical representation of 1s and 0s that can be detected via a switch 255. For example, as shown in FIG. 2C, the mechanical switch 255 can detect a protrusion 257 encoded on the plunger 220. As shown in FIGS. 2B and 2C, a binary layout or a Gray code layout may be used. The 8-bit number detected by the switch 255 can then be transmitted to an external device.

[0038] According to another exemplary embodiment, the sensing means may comprise a sleeve including a linear encoder. Figures 3A, 3B, and 3C illustrate a smart syringe 300 with a reusable sleeve 360 ​​including a linear encoder. As shown, the syringe 300 includes a reusable sleeve 360 ​​containing electrical and communication circuitry for determining and relaying dosage information. The sleeve 360 ​​includes a custom linear encoder that tracks the position of the plunger 320 throughout the injection. As shown in Figure 3A, gradations 322 on the syringe 300 may be visible when the syringe 300 is initially placed within the sleeve 360. The sleeve 360 ​​may then be closed around the syringe. As shown in Figure 3B, the sleeve may include a Hall-effect linear encoder 370 and a strip magnet 375. As an alternative As shown in FIG. 3C, the sleeve may include multiple anisotropic magnetoresistive (AMR) sensors 380 with a single magnet 385 disposed on the plunger 320 .

[0039] According to another example embodiment, the means for sensing may include a rotary encoder. Figures 4A, 4B, and 4C illustrate a smart syringe including a plunger with a rotary encoder according to an example embodiment. Syringe 400 includes plunger 420 including a linear thread 405 and a linear-to-rotary converter 410. As shown in Figure 4B, plunger 420 may include square threads 407, whose linear motion is converted to rotary motion by converter 410. Similarly, converter 410 may include a switch 412 for detecting the presence of syringe 400 and diametrically spaced magnets with a rotary encoder 414 for detecting rotary motion.

[0040] According to another exemplary embodiment, the means for sensing may comprise an image that can be analyzed and used to determine the injected dosage and fill level. Figures 5A and 5B illustrate a smart syringe 500 that includes a plunger 520 provided with a pattern 521 thereon that can be read by a smart accessory. In 5B As shown, the pattern 521 on the plunger 520 aligns with the units on the barrel 530 of the syringe 500 so that the pattern can be read by the smart accessory and the units of insulin in the syringe 500 can be derived. As shown, the pattern may comprise a series of triangles, or may comprise other shapes as will be understood by those skilled in the art. The smart accessory or other external device may be an external device such as a cell phone running an app described herein and includes an image capture device such as a camera that can obtain an image of the smart syringe. Similarly, the device may include a processor that runs the app or other software, thereby configuring the device to analyze the image and thereby determine the fill level of the syringe.

[0041] 6 illustrates an electrical circuit of a rotary encoder according to an example embodiment. As shown, rotary encoder 600 includes a magnetic rotary encoder integrated with circuitry 601 and a microcontroller 602.

[0042] According to another exemplary embodiment, the means for sensing may include a micro-electro-mechanical systems (MEMs) flow sensor.

[0043] An accelerometer (not shown) may be included in one or more of any of the exemplary smart syringes described above to determine when the skin is punctured by the needle, thereby enabling the user to plan the injection. Ja This will allow you to determine the position of the object.

[0044] According to an example embodiment, the means for communication may include one or more of Near Field Communication (NFC), Bluetooth, and ZigBee. Bee® and any other wireless communication system as would be understood by one skilled in the art.

[0045] According to an example embodiment, as shown in FIG. 7, a smart syringe 700 containing an NFC chip can be brought close to ("tapped") a smart device 770, such as a phone, that contains an app.

[0046] FIG. 8 illustrates a smart syringe system including a smart syringe 800 and an app-enabled external device 850. In FIG. 8, the smart syringe 800 is illustrated as a smart syringe including a plunger with a rotary encoder. However, the smart syringe 800 may be any of the smart syringes described in the above-described embodiments. By way of example, the external device 850 may be a smartphone, as shown, or a laptop, tablet, personal computer, or other app-enabled processing device. The smart syringe 800 and the app-enabled external device 850 may be connected wirelessly, for example, via NFC. The two communication platforms may be different combinations of hardware and software. Data communication between the smart syringe 800 and the external device 850 may vary depending on when and how the data communication occurs. For example, the smart syringe 800 may communicate data regarding drug delivery status (e.g., completed or incomplete) or other delivery information systems (e.g., rate, timing, etc.) in real time (i.e., during injection) or at any time after injection, such as when a previously unconnected device finally pairs or otherwise connects. The communication connection may be performed via any type of wireless connection method, including, but not limited to, NFC, Bluetooth™, and WiFi, which may affect device pairing and, if necessary, device proximity requirements. The appropriate proximity of the devices to one another is determined by the use of the connection method as understood by those skilled in the art. The timing of data communication may depend, at least in part, on the communication between the two communication platforms, and / Or at least it can be determined whether the smart syringe 800 has the capacity to record time.

[0047] According to an aspect of an example embodiment, the external device 850 may be a smartphone provided with a delivery information system app that connects and interfaces with the smart syringe 800. For example, using standard NFC technology methods, a user may pair the smartphone with the smart app for synchronization.

[0048] Synchronization of data between the smart syringe 800 and the app may occur after each injection, for example to obtain delivery data. The app may advantageously provide the ability to record time (e.g., data provided during or immediately after injection may be stored in the external device 850 or in external memory, such as the cloud, with a time stamp).

[0049] With respect to the apps described herein, as explained above, they may be standalone apps stored and running on a smartphone or other external device 850, or they may be provided as an extension to a digital health app. Similarly, a medical event image capture app can be integrated into a digital health app (e.g., the BD® Diabetes Care app). For example, the app and its resulting information system can be automatically combined with other digital health app content, such as injection logging, exercise logging, carbohydrate intake logging, and blood glucose logging, to assist patients and disease management stakeholders in tracking patient compliance with prescribed disease management regimens (e.g., how well a patient maintains target blood glucose levels), reordering essential supplies (e.g., self-injection devices and home health essentials such as medications and pharmacy inventory), automatically shipping prescribed medications and supplies to patients and commercial settings, tracking inventory, and billing for medical events captured within clinical settings. As an alternativeThe app can be a standalone app that interacts with the user (e.g., patient) or caregivers (e.g., parents, spouse, nurse), healthcare providers, clinical site managers, pharmacies, payers (e.g., insurance companies), and other stakeholders on the patient's medical management team, such as medical device suppliers and distributors.

[0050] While the exemplary embodiments described herein relate to diabetes management and insulin injections, it should be understood that the operation of the app described herein can be used to reduce errors related to the management or treatment of other medical conditions that require the use of various devices, such as surgical instruments, blood collection and delivery products, and delivery of medications other than insulin, and various medical condition management procedures. For example, exemplary embodiments can be used to reduce medical errors related to self-injection with other types of medications, the correct use of surgical tools for selected medical procedures, the correct use of devices for the delivery of medical fluids to patients via IV, etc.

[0051] 9A-9E illustrate exemplary information that the app can display on a smartphone.

[0052] As shown in FIG. 9A, tapping (i.e., bringing close to touching) a smart syringe including NFC transmitting capabilities on an external device running the app may cause the app to display or otherwise output a notification to the user. FIG. 9B illustrates an example app display screen at start-up prompting the user to enter dosage units. FIG. 9C illustrates an example app display screen requesting confirmation of the type of insulin injected once the dosage has been entered. FIG. 9D illustrates an example display screen once the injection has been confirmed. FIG. 9E illustrates an example display screen allowing the user to manually record an insulin dose by tapping a button. Other optional records are displayed below the insulin record.

[0053] Components of the illustrative devices, systems, and methods used in accordance with the illustrated embodiments described herein can be implemented at least partially in digital electronic circuitry, analog electronic circuitry, or computer hardware, firmware, software, or combinations 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 machine-readable storage device for execution by or to control the operation of a data processing apparatus such as a programmable processor, computer, or multiplexer.

[0054] 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 suitable for use in a computing environment, either as a stand-alone program or as modules, components, subroutines, or other units. A computer program can be run on a computer or other device, or in a single location. 、 or distributed across multiple locations Multiple devices , and Through communication networks mutual connected On the device The present invention can be deployed to perform various functions. Furthermore, functional programs, codes, and code segments for performing the features described herein can be readily developed by a programmer skilled in the art. Method steps associated with exemplary embodiments can be performed by one or more programmable processors that execute computer programs, codes, or instructions to perform functions (e.g., by manipulating input data and / or generating output). Similarly, method steps can be performed by special purpose logic circuitry, such as a field programmable gate array (FPGA) or an application-specific integrated circuit (ASIC), and the apparatus described herein can be implemented as special purpose logic circuitry, such as a field programmable gate array (FPGA) or an application-specific integrated circuit (ASIC).

[0055] The various illustrative logic blocks, modules, and electrical circuits described in connection with the embodiments set forth herein may be implemented or embodied in a general-purpose processor, a digital signal processor (DSP), an ASIC, an 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 alternatively, the processor may be any conventional processor, controller, microcontroller, or state machine. Similarly, a processor may be implemented as a combination of computing devices, such as a combination of a DSP and a microprocessor, multiple microprocessors, one or more microprocessors in conjunction with a DSP core, or any other such configuration.

[0056] Processors suitable for executing a computer program include, by way of example, both general-purpose and special-purpose microprocessors, and any one or more processors of any kind of digital computer. Typically, a processor receives 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. Typically, a computer also includes one or more mass storage devices for storing data, such as magnetic, optical, or magnetic disks, or is operatively coupled to receive data from or transmit data to one or more mass storage devices, or both. Information carriers suitable for embodying computer program instructions and data include, by way of example, all forms of non-volatile memory, including semiconductor memory devices, such as, for example, erasableExamples include programmable read-only memories (EPROMs), electrically erasable programmable ROMs (EEPROMs), flash memory devices, and data storage disks (e.g., magnetic disks, internal or removable disks, magneto-optical disks, and CD-ROM and DVD-ROM disks). Processors and memory can be supplemented by, or incorporated in, special purpose logic circuitry.

[0057] The computer-readable non-transitory medium includes any type of computer-readable medium, including magnetic storage media, optical storage media, flash media, and solid-state storage media. It is understood that the software may be sold installed on a central processing unit (CPU) device. As an alternative The software can be obtained and loaded onto a CPU device, including obtaining the software through physical media or a distribution system, such as from a server owned by the software creator or from a server used by but not owned by the software creator. The software can be stored on a server for distribution, for example, over the Internet.

[0058] 10 is a chart of the operation of a smart syringe and an external device according to an example embodiment. As shown, the smart syringe "tap" the external device to establish communication between them (1001). As shown in FIG. 10, the tap occurs before administering the dose. However, As an alternative A tap may occur a certain time after the dose is administered. The smart syringe administers the dose to the patient and senses the dose (1002). Information about the dose is sent to an app to run on the external device (1003). The app then processes the received information (1004) and displays the information to the patient (1005).

[0059] It can be understood that the example embodiments described herein can be considered in an illustrative sense only and not for purposes of limitation, and that the description of a feature or aspect within each example embodiment can be considered applicable to other similar features or aspects in other example embodiments.

[0060] Although exemplary embodiments have been described with reference to the figures, it will be understood by those skilled in the art that various changes in form and detail may be made therein without departing from the spirit and scope as defined by the following claims.

Claims

1. 1. A smart syringe system, comprising: a body having a scale formed thereon; a plunger having a series of triangles formed thereon extending along a length parallel to a longitudinal axis, the relative position of the plunger with respect to the body being determinable based on an optical comparison of the relative positions of the scale and the relative positions of the series of triangles; a syringe comprising: A device external to the syringe, an image capture device; a processor configured to analyze images acquired by the image capture device to determine a fill level of the syringe based on the relative positions of the scale and the relative positions of the successive triangles; an apparatus comprising: A smart syringe system comprising:

2. A smart syringe system as described in claim 1, wherein each of the triangles in the series of triangles is arranged with its bottom facing toward a first end of the plunger and its tip facing toward a second end of the plunger.

3. 2. The smart syringe system of claim 1, wherein the device external to the syringe further comprises a memory for storing software instructions, and wherein the processor is configured to execute the software instructions to run an application configured to cause the processor to display information about the fill level of the syringe.

4. The smart syringe system of claim 1 , wherein the device external to the syringe is a mobile phone.

5. 2. The smart syringe system of claim 1, wherein the successive triangles overlap such that the base of one triangle in the succession overlaps the tip of an adjacent triangle in the succession.

6. The smart syringe system of claim 1, wherein the plunger further includes a formed continuous line adjacent to the continuous triangles and extending along the length parallel to the longitudinal axis of the plunger.

7. A method for detecting dosage information by a smart syringe system according to any one of claims 1 to 6, comprising: receiving the image at the processor of the device; analyzing the image by the processor of the device; displaying information about the fill level of the syringe by the device; A method comprising:

8. the image includes an image of the scale and an image of the continuous triangle; The method of claim 7 , wherein the analyzing step comprises determining, by the processor of the external device, the relative positions of the successive triangles with respect to the position of the scale.

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