Smart injector with dose capture and smartphone app

Abstract

An intelligent syringe system and method are provided. The system includes an intelligent syringe and an external device. The syringe obtains data of a dose administered to a patient and wirelessly transmits the data to the external device. Alternatively, the external device obtains the data via an image of the syringe. The external device can execute an application configured to process the data and display dose information.

Description

[0001] Cross-references to related applications

[0002] This application claims priority to U.S. Provisional Application 63 / 017,347, filed April 29, 2020, with the United States Patent and Trademark Office, the disclosure of which is incorporated herein by reference in its entirety. Technical Field

[0003] The apparatus and methods consistent with the example embodiments relate to syringes for transferring (i.e., injecting or withdrawing) fluid, and more particularly, to smart syringes that sense and provide information related to filling volume and dosage and can transmit the information to a smartphone application (app). Background Technology

[0004] Medication non-adherence is a significant global problem, particularly in diabetes care. An estimated 50 percent of all patients do not take their prescribed medications. Non-adherence directly causes hundreds of thousands of deaths and incurs billions of dollars in preventable medical and related costs.

[0005] Currently, smartphone apps are being used that use images of prescription labels to help patients reorder prescription medications when supplies are low. However, these apps do not directly identify the medication or dosage before the patient takes it and cannot be used specifically with syringes or pen syringes.

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

[0007] Nevertheless, there remains a continued need for methods and equipment to help users (e.g., patients, their caregivers, their healthcare providers, and other health condition management stakeholders such as payers / insurance companies, pharmacies, and medical product suppliers and distributors) access and use information related to health condition management events to prevent medical errors (such as medication delivery errors) and to improve related processes (such as restocking medical supplies, tracking adherence to health condition management protocols or programs, and sharing information among health condition management stakeholders for optimal patient care treatment plans, billing, and insurance coverage purposes).

[0008] The typical syringe 100 shown 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. Printed on the barrel 10 is a scale 12 to enable the user to administer the correct dose. 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. The plunger rod 25 engages the rubber stopper 20 to move it back and forth under the user's control. A metal needle 30 or hub is usually attached to the distal end of the barrel to allow the injection of fluids into or removal from the body, but this is not always the case. For example, a syringe with a male Luer connector at 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 hub.

[0009] A large number of syringes can be used in hospitals and care facilities in relatively short periods of time and by patients for certain conditions. The needles can be detachably connected to the barrel using Luer-Lok TM or Luer slip connections, or they can be permanently attached or "staked" to the barrel during the syringe manufacturing process.

[0010] Effective administration of some types of medication injections, particularly in the case of insulin use by diabetic patients, requires that all doses administered be recorded. While patients are educated for home injections, most patients still find it challenging to correctly follow the instructions day after day. Additionally, the only means of obtaining a record of injections and injection doses is by manually recording them. Health care personnel can record information related to doses in a clinical setting, but the overhead associated with capturing this information is significant. It is also difficult to measure and record certain injection times and doses. Certain patients can also find it difficult to draw a very specific amount of medication into a syringe and / or determine the specific amount of medication that has been injected because it is difficult to read the scale markings on the syringe barrel or to correctly follow the instructions.

[0011] There is a need for an improved syringe that can provide a user with more accurate information about the doses delivered and adherence to a prescribed medication dosage regimen. SUMMARY

[0012] 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 do not require overcoming the disadvantages described above and can not overcome any of the problems described above.

[0013] According to one aspect of the example embodiments, 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 with respect to the body can be determined based on an optical comparison of the relative positions of the first and second patterns. The device includes an image capture device and a processor configured to analyze the image capture device and thereby determine a fill level of the syringe.

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

[0015] The second pattern can be a series of triangles extending along a length parallel to a length of the plunger.

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

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

[0018] The sensing component can be one of a linear encoder and a rotary encoder.

[0019] The sensing component can be a sleeve disposed about a barrel of the syringe, the sleeve including the linear encoder.

[0020] The first and second communication components can be a near field communication (NFC) transmitter and an NFC receiver, respectively.

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

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

[0023] The syringe can also obtain the data via one of a linear encoder and a rotary encoder. BRIEF DESCRIPTION OF DRAWINGS

[0024] The above and / or other example aspects and advantages will become apparent and more readily appreciated from the following description, taken in conjunction with the accompanying drawings, of which:

[0025] FIG. 1 illustrates a disposable syringe according to the related art;

[0026] Figure 2A 、 2B and 2C illustrate an example smart syringe with a linear encoder according to example embodiments;

[0027] Figure 3A 、 3B and 3C illustrate an example smart syringe with a linear encoding sleeve according to example embodiments;

[0028] Figure 4A 、 4B and 4C illustrate an example smart syringe with a rotary encoder according to example embodiments;

[0029] Figure 5A and 5B illustrate an example smart syringe with a plunger having a pattern thereon according to example embodiments;

[0030] Figure 6 illustrate circuitry of a rotary encoder according to example embodiments;

[0031] Figure 7 illustrate a smart syringe tapping an external device according to example embodiments;

[0032] Figure 8 illustrate a system including a smart syringe and an external device according to example embodiments;

[0033] Figures 9A to 9E illustrate information that an application can cause to be displayed on an external device according to example embodiments; and

[0034] Figure 10 is an operational flowchart of a smart syringe and an external device according to example embodiments. DETAILED DESCRIPTION

[0035] Reference will now be made in detail to example embodiments illustrated in the accompanying drawings, where like reference numerals refer to like elements throughout. In this regard, example embodiments can have different forms and the description set forth herein is not intended to limit the aspects of the present description.

[0036] It should 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.

[0037] It will be further 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 simply used to distinguish one element, component, region, layer or section from another element, component, region, layer or section.

[0038] 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 elements for performing at least one function or operation, and can be implemented in hardware, software, or a combination of hardware and software.

[0039] Various terms are used to refer to particular system components. Different companies may refer to components by different names — the document does not intend to distinguish various components that differ in name but not in function.

[0040] Matters apparent to those of ordinary skill in the art of the example embodiments can not be described in detail.

[0041] As discussed above with respect to FIG. 1, a 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 attached 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.

[0042] According to example embodiments, a smart syringe includes components for wireless communication with an external device, and components for sensing one or more of a dose of injection and a fill level.

[0043] The components for transmitting can be one or more of capacitive, resistive, inductive, antenna attenuation, color coding, and digital coding.

[0044] According to one example embodiment, the components for sensing include a resistive film disposed on the syringe barrel exterior or the syringe plunger shaft. The sliding tabs can be arranged such that the resistance between the two sliding tabs changes as the plunger is drawn out to draw the medication into the syringe, or as the plunger is depressed to inject the medication into the user. Circuitry that can be disposed under the finger tabs or on the syringe thumb rest can monitor the resistance between the sliding tabs and can transmit that information to an external device.

[0045] According to another example embodiment, the component used for sensing includes a linear encoder, such as a Hall effect linear encoder.

[0046] Figure 2A , 2B Illustration 2C shows an example smart injector 200 with a linear encoder 250. The smart injector 200 includes a digitally coded plunger 220 that can be used entirely in one disposable manner. Figure 2B and 2C As shown, plunger 220 includes mechanical representations of 1 and 0 detectable via switch 255. For example, mechanical switch 255 can detect bumps 257 coded on plunger 220, such as... Figure 2C As shown in the image. It can be used as follows: Figure 2B and 2C The binary layout or gray code layout shown is used. The 8-bit number detected by switch 255 can then be transmitted to an external device.

[0047] According to another example embodiment, the sensing component may include a sleeve comprising a linear encoder. Figure 3A , 3B The diagram illustrates a smart syringe 300 with a reusable sleeve 360, which includes a linear encoder. As shown, the syringe 300 includes a reusable sleeve 360 ​​that incorporates electronics and communication circuitry for determining and transmitting dosage information. The sleeve 360 ​​includes a custom-designed linear encoder that tracks the position of the plunger 320 throughout the injection process. Figure 3A As shown, the gradient 322 on the syringe 300 may be visible when the syringe 300 is initially positioned within the sleeve 360. The sleeve 360 ​​can then be closed around the syringe 300. The sleeve may include a Hall effect linear encoder 370 and a bar magnet 375, as shown. Figure 3B As shown in the diagram. Alternatively, the sleeve may include multiple anisotropic magnetoresistive (AMR) sensors 380, with a single magnet 385 deployed on the plunger 320, as illustrated. Figure 3C As shown in the image.

[0048] According to another example embodiment, the component used for sensing may include a rotary encoder. Figure 4A , 4B Figure 4C illustrates a smart injector including a plunger with a rotary encoder according to an example embodiment. Injector 400 includes a plunger 420, which includes a threaded linear portion 405 and a linear-to-rotary transducer 410. The plunger 420 may include a square thread 407, such as... Figure 4BAs shown in FIG. 4A, the linear movement of the plunger 420 is converted to rotational movement by a converter 410. The converter 410 can also include a switch 412 for detecting the presence of the syringe 400, and a radially separated magnet with a rotary encoder 414 for detecting rotational movement.

[0049] According to another example embodiment, the means for sensing can include an image that can be analyzed and thereby used to determine an injection dose or fill level. Figure 5A and 5B An intelligent syringe 500 is illustrated that includes a plunger 520 that is provided with a pattern 521 that can be read by an intelligent accessory. As shown in FIG. Bb, the pattern 521 on the plunger 520 is aligned with units on the barrel 530 of the syringe 500 so that the intelligent accessory can read the pattern and derive the units of insulin in the syringe 500. The pattern can include a series of triangles as shown or other shapes as will be appreciated by those skilled in the art. The intelligent accessory or other external device, which can be an external device such as a mobile phone that operates the application discussed herein, includes an image capture device such as a camera that can obtain an image of the intelligent syringe. The device also includes a processor that operates the application or other software, thereby configuring the device to analyze the image and thereby determine the fill level of the syringe.

[0050] Figure 6 Circuitry of a rotary encoder is illustrated according to an example embodiment. As shown, the rotary encoder 600 includes a magnetic rotary encoder integrated circuit 601 and a microcontroller 602.

[0051] According to another example embodiment, the means for sensing can include a microelectromechanical system (MEM) flow sensor.

[0052] An accelerometer (not shown) can be included in any one or more of the example intelligent syringes described above in order to determine when the skin is pierced by the needle, thereby enabling determination of the position of the plunger at the time of injection.

[0053] According to an example embodiment, the means for communicating can be one or more of near field communication (NFC), Bluetooth, Zigbee, and any other wireless communication system, as will be appreciated by those skilled in the art.

[0054] According to an example embodiment, an intelligent syringe 700 that includes an NFC chip can be placed in close proximity ("tapped") to a smart device 770, such as a phone that includes an application, as illustrated in Figure 7 FIG. 7B.

[0055] Figure 8 An intelligent syringe system is illustrated that includes an intelligent syringe 800 and an external device 850 that is enabled by an application. As shown in Figure 8In this regard, the smart syringe 800 is illustrated as a smart syringe including a plunger with a rotary encoder. However, the smart syringe 800 can be any smart syringe as discussed with respect to the above embodiments. The external device 850 can be, for example, a smartphone, as illustrated, or a laptop, tablet, personal computer, or other processing device that is application-enabled. The smart syringe 800 and the application-enabled external device 850 can be wirelessly connected, for example, by NFC. The two communication platforms can have different hardware and software combinations. The data transfer between the devices can differ depending on when and how the data transfer occurs between the smart syringe 800 and the external device 850. For example, the smart syringe 800 can transfer data (e.g., rate, timing, etc.) regarding the drug delivery status (e.g., complete or incomplete) or other delivery information 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 made via any type of wireless connection method, including but not limited to NFC, Bluetooth TM and WiFi, if needed, which can impact the device pairing and the need for device proximity. As will be appreciated by those skilled in the art, the proper proximity of the devices relative 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 syringe 800 has time recording capability.

[0056] According to one aspect of the example embodiments, the external device 850 can be a smartphone that is application-enabled with a delivery information application to connect to and cooperate with the smart syringe 800. The user can pair the smartphone with the smart application to synchronize, for example, using standard NFC technology methods.

[0057] The data synchronization between the smart syringe 800 and the application can occur at each injection, for example, to obtain the delivery data. The application can advantageously provide time recording capability (e.g., the data provided during or immediately after the injection can be stored in the external device 850 or in external storage, e.g., the cloud, with a time stamp).

[0058] With respect to the application described herein, it can be a standalone application stored and operated on the smartphone or other external device 850, as described above, or can be provided as an enhancement to a digital health application. The medical event image capture application can also be integrated into a digital health application (e.g., The application and information it generates can be automatically combined with other digital health application content, such as injection, exercise, carbohydrate intake, and blood glucose reading logs, to help patients and disease management stakeholders track patient adherence to a prescribed disease management regimen (e.g., the extent to which the patient maintains target blood glucose levels), reorder supplies (e.g., home health supplies such as self-injection equipment and medication and pharmacy inventory), and automatically ship prescribed medication and medical supplies to patients or commercial settings, inventory tracking, billing for medical events captured in a clinical setting, etc. Alternatively, the application can be a standalone application that communicates with a user (e.g., a patient) or other stakeholders in the patient's medical condition management team, such as a caregiver (e.g., a parent, spouse, school nurse), health condition care provider, clinical environment administrator, pharmacy, payer (e.g., an insurance company), and medical equipment suppliers and distributors.

[0059] The example embodiments described herein are directed to diabetes management and insulin injection. However, it should be understood that the operation of the application as described herein can be used to reduce errors associated with the management and treatment of other medical conditions that require the use of various equipment and medical condition management procedures, such as surgical instruments, blood collection and delivery products, delivery of other medications in addition to insulin, etc. For example, the example embodiments can be used to reduce medical errors associated with self-injection using other types of medications, correct use of surgical tools for selected medical procedures, correct use of equipment for IV delivery of medication fluids to patients, etc.

[0060] Figures 9A to 9E An example information that the application can cause to be displayed on the smart phone is illustrated.

[0061] Tapping (even if it is close to) a smart injector that includes NFC transmission capabilities on an external device running the application can cause the application to display or otherwise output a notification to the user as shown in Figure 9A Figure 9B An example display screen when the application is opened prompting the user to enter the units of the dose is illustrated. Figure 9C An example display screen of the application when the dose has been entered requesting confirmation of the type of insulin being injected is illustrated. Figure 9D An example display screen when the injection has been confirmed is illustrated. Figure 9E An example display screen enabling the user to manually record an insulin dose by tapping the button. Other optional log displays are shown below the insulin log.

[0062] ​Components of the illustrative devices, systems and methods employed 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 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.

[0063] A computer program can be written in any form of programming language, including compiled or interpreted languages, and 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 multiple devices at one site or distributed across multiple sites and interconnected by a communication network. Also, functional programs, codes, and code segments for accomplishing the features described herein can be easily developed by programmers skilled in the art. Method steps associated with the example embodiments described herein 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 output). Method steps can also be performed by, and apparatus described herein can be implemented as, special purpose logic circuitry, e.g., an FPGA or an ASIC, and the apparatus described herein can be implemented as a combination of special purpose logic circuitry, e.g., an FPGA or an ASIC, and one or more programmable processors.

[0064] The various illustrative logical blocks, modules, and circuits described in connection with the embodiments described herein can be implemented or performed with 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 can be a microprocessor, but in the alternative, the processor can be any conventional processor, controller, microcontroller, or state machine. A processor can 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.

[0065] 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., EPROM, EEPROM, and flash memory devices; magnetic disks, e.g., 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.

[0066] Computer readable non-transitory media includes all types of computer readable media, including magnetic storage media, optical storage media, flash memory, and solid state memory. It will be appreciated that software can be installed in and sold with a central processing unit (CPU) device. Alternatively, software can be acquired and loaded into a CPU device, including by obtaining the software through a physical medium or distribution system, including, for example, from a server owned by the software creator or from a server used by the software owner but not owned by the software creator. For example, software can be stored on a server for distribution over the Internet.

[0067] Figure 10 is an operational flowchart of a smart syringe and external device according to example embodiments. As shown, the smart syringe "taps" the external device, establishing communication between them (1001). As shown in Figure 10 The tap occurs prior to administering the dose, as shown in the middle. However, alternatively, the tap can occur at a later point in time after administering the dose. The smart syringe administers the dose to the patient and senses the dose (1002). When operating on the external device, information about the dose is transmitted to the application (1003). The application then processes the received information (1004) and displays information to the patient (1005).

[0068] It can be appreciated that the example embodiments described herein can be considered merely descriptive and not for purposes of limitation. Descriptions of features or aspects within each example embodiment can be considered to apply to other similar features or aspects in other example embodiments.

[0069] While 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 defined by the following claims.

Claims

1. A smart syringe system, comprising: Syringe, including: The main body, with scales formed on it, and A plunger having a series of triangles formed thereon, the series of triangles extending along a length parallel to the longitudinal axis of the plunger, such that the relative position of the plunger with respect to the body can be determined based on an optical comparison of the scale and the relative positions of the series of triangles; and A device located outside the syringe, the device comprising: Image capture devices, and The processor is configured to analyze the image capture device based on the scale and the relative positions of the series of triangles, thereby determining the fill level of the syringe.

2. The intelligent injector system of claim 1, wherein each of the series of triangles is arranged with a base facing a first end of the plunger and a point facing a second end of the plunger.

3. The intelligent syringe system of claim 1, wherein the device located outside the syringe further includes a memory storing software instructions, and wherein the processor is configured to execute the software instructions and thereby execute an application configured to cause the processor to display information about the fill level of the syringe.

4. The intelligent syringe system according to claim 1, wherein the device located outside the syringe is a mobile phone.

Images