Systems, devices, and methods for image capture of medical condition management events

Abstract

A medication delivery device system with a variable indicator and methods for using the same are provided. The medication delivery device system includes a syringe and / or syringe components (e.g., needle shield, needle guard), or a pen-type autoinjector with a variable indicator, or a wearable autoinjector with a variable indicator, and a software application for an external device that analyzes images of the variable indicator to automatically determine and record the status of the medication delivery device. Variable indicators or variable codes on or components of the medication delivery device represent different medical events, such as completion of medication, dosage, and deployment or removal of a safety feature, and can be detected or otherwise recorded by the external device. The external device can execute an application configured to further process data obtained by captured images of the variable indicator and display relevant information (e.g., fluid remaining in the syringe barrel, administered dosage, etc.).

Description

Technical Field

[0001] The present invention relates to systems, devices, and methods for image capture of medical condition management events.

Background Art

[0002] Reference to Related Applications This application claims the benefit of U.S. Provisional Application No. 63 / 017,347, filed Apr. 29, 2020, the entire content of which is incorporated herein by reference.

[0003] 1. Field Apparatuses and methods consistent with an example embodiment relate to drug delivery devices for moving (i.e., injecting or withdrawing) fluids, such as syringes, pen-type autoinjectors, and wearable autoinjectors, and more particularly to syringes and / or related components (such as syringe needle shields and needle receivers) or pen-type autoinjectors, or wearable autoinjectors, provided with variable indicators for providing information regarding, among other things, the syringe or syringe components, or autoinjector, or fill volume, or status (e.g., use or stage of use) of the administered dose, and to a smartphone application (app) that facilitates capture and transmission of information.

[0004] 2. Description of Related Art Lack of medication adherence has become a problem of global significance, particularly with respect to 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 tens of billions of dollars in avoidable medical and related costs.

[0005] A smartphone app is currently in use that helps patients reorder when the supply of prescribed medication runs low by using a photo of the prescription label. However, these apps do not allow patients to directly verify the medication or dosage before taking it, and do not account for specific uses in combination with syringes or pen injectors.

[0006] There are other smartphone apps that help users by recording medical events such as injections, and smart injection devices (i.e., smart pen injectors) that can help users by automatically recording the amount adjusted on a dial for drug administration and / or the amount of drug administered.

[0007] Nevertheless, there remains a continuing need for methods and devices that assist users (e.g., patients, their caregivers, their healthcare providers, and payers / insurance companies, pharmacies and medical product suppliers and medical product vendors, other stakeholders in disease management) in obtaining and using information related to disease management events to track compliance with disease management protocols or regimens, improve related processes such as replenishment of medical supplies, avoid medical errors such as drug administration mistakes, and facilitate information sharing among stakeholders in disease management for optimal patient care plans, billing, and insurance reimbursement intentions.

[0008] Effective administration of certain drug injections, particularly insulin used by diabetic patients, requires maintaining records for all doses administered. Many patients use low-cost and often disposable administration devices, such as syringes or pen self-injectors, to administer their prescribed medications. These devices are relatively easy to use, but typically lack any features that would help patients or healthcare workers record their use in relation to compliance with a drug treatment regimen.

[0009] For example, patients are prompted to record the date, time, and amount of self-injection with a syringe or pen-type autoinjector. Education is provided to patients who perform self-injections, but most patients still find it difficult to consistently follow the instructions on a daily basis. Moreover, the only means of obtaining a record of the injection and the dosage administered is by manually writing it down. Also, a patient may realize that it is difficult to draw a specific amount of drug into the syringe and / or determine the specific amount of drug administered, because it is difficult to read the scale markings on the barrel of the syringe or to follow the instructions properly.

[0010] The difficulty of recording injection information with syringes and pen-type autoinjectors can also exist in a clinical setting. For example, healthcare providers can be better trained than patients in recording information related to dosage, but the costs associated with capturing this information are significant. It can be difficult for healthcare providers to measure and record the exact time and dosage of an injection for multiple patients in a clinical setting, from a time and convenience perspective. SUMMARY OF THE INVENTION

[0011] An example of an embodiment can address at least the above problems and / or disadvantages, as well as other disadvantages not described above. Also, an example of an embodiment is not required to overcome the disadvantages described above and may not overcome any of the problems described above.

[0012] There is a need for an improved drug administration device that can provide users with a more convenient, less conflicting, and more accurate capture of information regarding injection events and the dosage administered, for improved adherence to a prescribed drug dosage regimen.

[0013] According to an example of an embodiment, the medical administration system comprises a drug administration device selected from the group consisting of a syringe, a pen-type self-injector, and a wearable self-injector. The drug administration device has a variable indicator that is changed after a specified action regarding the drug selected from the group consisting of removal of the pen cap, or removal of the needle cap, movement of the plunger, or movement of another drive mechanism that supplies fluid from the drug administration device, mechanical movement of the parts of the drug administration device, and movement of the parts of the drug administration device after the fluid has been supplied. The medical administration system also comprises a set of computer-readable instructions that analyze an image of the variable indicator and assign a first state to the drug administration device when the analysis of the image detects that the variable indicator is unchanged, assign a second state to the drug administration device when the analysis of the image detects that the variable indicator has been changed by a specified action regarding the drug administration device, and store the assigned state in a memory device.

[0014] According to an aspect of an example of an embodiment, the set of computer-readable instructions stores in the memory device, each associated with a timestamp corresponding to the assigned state.

[0015] According to an aspect of an example of an embodiment, the set of computer-readable instructions is within a software application stored in the memory of a digital device, and the image is generated by a camera associated with the digital device.

[0016] According to an aspect of an example of an embodiment, the first indicator comprises one or more features selected from the group consisting of a machine-readable code, a barcode, a printed indicator, an etched indicator, an alphanumeric indicator, a color-coded indicator, an optical indicator, an indicator showing a measurement scale, an indicator with one or more stripes, and an indicator with one or more shapes.

[0017] According to an aspect of an example of the embodiment, the first indicator is changed by an operation selected from extending the first indicator, shortening the first indicator, changing the optical characteristics of the first indicator, and changing the physical characteristics of the first indicator.

[0018] According to an aspect of an example of the embodiment, the set of computer-readable instructions is configured to communicate a determined first state or a determined second state to another device.

[0019] According to an aspect of an example of the embodiment, the drug delivery device is a syringe, and the variable indicator includes at least a first indicator provided on the syringe. The syringe includes a barrel having a cavity for holding a fluid, an opening at a proximal end of the syringe for accommodating a plunger, an opening at a distal end of the syringe for coupling with a needle of the fluid, and a plunger movable within the cavity of the barrel and having a stopper on a distal end of the plunger. The set of computer-readable instructions analyzes an image of the first indicator and assigns the first state to the syringe when the analysis of the image detects that the first indicator is unchanged, and assigns the second state to the syringe when the analysis of the image detects that the first indicator has been changed by the movement of the plunger.

[0020] According to an aspect of an example of the embodiment 、 The set of computer-readable instructions is configured to communicate a determined state of the syringe to another device

[0021] According to an aspect of an example of the embodiment, the first state of the syringe is a pre-administration state, and the second state of the syringe is selected from the group consisting of an administration started by the movement of the plunger and an administration completed by the movement of the plunger reaching the end position.

[0022] According to an aspect of an example of an embodiment, the set of computer-readable instructions is configured to determine the state of the syringe selected from the group consisting of the distance the plunger moves, the amount of fluid remaining in the syringe, and the amount of fluid administered from the syringe by the movement of the plunger.

[0023] According to an aspect of an example of an embodiment, the variable indicator can comprise a second indicator, and at least one of a stopper and the second indicator on the plunger is provided, or a stopper is provided. When a state is generated that is selected from the first indicator at least partially blocked by the stopper, the first indicator at least partially blocked by the second indicator, and the first and second indicators associated with an image representing the second state of the syringe, the image analysis detects that the first indicator is changed by the movement of the plunger.

[0024] According to an aspect of an example of an embodiment, the syringe comprises a needle shield removably attached to the syringe, the needle shield being configured to cover the needle before the needle shield is removed and to expose the needle after the needle shield is removed. The first indicator is provided on the needle shield and is configured to be changed by the removal of the needle shield from the syringe. The first state of the syringe is the needle shield attached to the syringe, and the second state of the syringe is the needle shield removed from the syringe.

[0025] According to an aspect of an example of an embodiment, the set of computer-readable instructions is configured to communicate the determined first state of the needle shield attached to the syringe to another device, or to communicate the determined second state of the needle shield removed from the syringe to another device.

[0026] According to an aspect of an example of an embodiment, the first indicator is provided on the syringe as a printed label that is affixed to the syringe, is separated from the syringe when removing the needle shield from the syringe, and is operable on a part of the printed label that changes the first indicator by being separated.

[0027] According to an aspect of an example of an embodiment, when the needle shield is attached to the syringe to represent the first state of the syringe, the needle obscures at least a part of the first indicator, and when the needle shield is removed from the syringe to represent the second state of the syringe, the first indicator is not obscured by the needle.

[0028] According to another aspect of an example of an embodiment, the medical administration system further includes a needle receiver. The needle receiver has a needle receiver plunger having a plunger cavity for at least partially accommodating the syringe, and a body having a body cavity for at least partially accommodating the needle receiver plunger. The needle receiver plunger has an opening at a proximal end of the needle receiver plunger for accommodating the syringe in the plunger cavity, and an opening at a distal end of the needle receiver plunger through which the needle of the syringe extends with a distal end penetrating in the pre-administration state. The body has a spring mechanism at a distal end of the body for putting the distal end of the needle receiver plunger in an energy storage state during the pre-administration state. The spring mechanism is operable in a released energy state for advancing the needle receiver plunger and the syringe toward the proximal end of the body to retract the needle of the syringe into the body after the syringe has completed fluid administration from the syringe. The first indicator provided on the syringe is unchanged during the pre-administration state and is changed after the spring mechanism has advanced the needle receiver plunger and the syringe to retract the needle into the body.

[0029] According to an aspect of an example of an embodiment, the body includes a window through which the first indicator on the syringe is visible.

[0030] According to an aspect of an example of an embodiment, the variable indicator can include a second indicator, and at least one of a stopper and a second indicator on the plunger or a second indicator on the stopper is provided on the plunger of the syringe. When a situation is selected from the fact that the first indicator is at least partially blocked by the stopper, the first indicator is at least partially blocked by the second indicator, and the first indicator and the second indicator are combined in an image representing the second state of the syringe, when the first indicator is changed by the movement of the plunger, the analysis of the image detects it.

[0031] According to an aspect of an example of an embodiment, the analysis of the image uses a combination of the first indicator and the second indicator to detect that a spring mechanism has advanced the needle receiving plunger and the syringe to retract the needle into the body.

[0032] According to an aspect of an example of an embodiment, the variable indicator can include a second indicator, and the second indicator is provided on the plunger of the syringe. The analysis of the image uses a combination of the first indicator and the second indicator to detect that a spring mechanism has advanced the needle receiving plunger and the syringe to retract the needle into the body.

[0033] According to an aspect of an example of an embodiment, the analysis of the image determines whether the combination of the first indicator and the second indicator includes a modified indicator having a length increased from the first indicator or the second indicator.

[0034] According to an aspect of an example of an embodiment, a set of computer-readable instructions is configured to communicate to another device a determined first state corresponding to the syringe being invariant during the pre-administration state, or a determined second state corresponding to advancing the needle receiving plunger and the syringe to retract the needle into the body.

[0035] According to an aspect of an example of an embodiment, the needle holder includes a needle holder plunger having a plunger cavity for at least partially accommodating a syringe, and a body having a body cavity for at least partially accommodating the needle holder plunger. The needle holder plunger has, at a proximal end portion of the needle holder plunger, an opening for accommodating the syringe in the plunger cavity, and an opening at a distal end portion of the needle holder plunger through which the needle of the syringe extends in a pre-administration state. for The body has, at a distal end portion of the body, a spring mechanism for bringing the distal end portion of the needle holder plunger into an energy storage state during the pre-administration state, and the spring mechanism is operable in a released energy state for advancing the needle holder plunger and the syringe toward a proximal end portion of the body to retract the needle of the syringe into the body after the syringe has completed fluid administration from the syringe. The variable indicator includes a first indicator provided on the body and a second indicator provided on the needle holder plunger, and the variable indicator is assigned a first state by a set of instructions during the pre-administration state, and the variable indicator is assigned a second state when the variable indicator is changed after the spring mechanism has advanced the needle holder plunger and the syringe to retract the needle into the body.

[0036] According to an aspect of an example of another embodiment, the drug administration device is a pen-type autoinjector, and a pen cap removably attached to the pen-type autoinjector, a needle removably attached to the pen-type autoinjector, a dose window through which a fluid for administration and a drive mechanism configured to discharge the fluid from the pen-type autoinjector are visible, and a variable indicator is provided on at least one of a fluid cartridge when the pen-type autoinjector is reusable. According to an aspect of an example of another embodiment, the variable indicator is provided on or on the body of the pen-type autoinjector and adjacent to the dose window, and the drive mechanism has a rubber seal at its distal end that is moved to supply the fluid. A set of computer-readable instructions analyzes one or more images of the variable indicator and assigns a first state to the drug administration device when the analysis of the one or more images detects that the variable indicator is invariant, and the variable indicator is at least partially blocked by the rubber seal, and there is a change in the position of the blocked portion of the variable indicator by the rubber seal, and at least one of the supply of the fluid or the movement of the rubber seal causes a change in the variable indicator related to a measurement scale provided on or adjacent to the dose window. When the analysis of the one or more images detects a situation selected from the group consisting of, the drug administration device is assigned a second state.

Brief Description of the Drawings

[0037] The above and / or other exemplary aspects and advantages will become apparent and be more readily understood correctly from the following description of an example of an embodiment when considered in conjunction with the accompanying drawings.

[0038]

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[0039] Here, the reference is made in detail to an example of an embodiment illustrated in the accompanying drawings, and like reference numerals refer to like elements throughout the specification. In this regard, an example of an embodiment may have different forms and cannot be construed as limited to the description set forth herein.

[0040] An example of an embodiment described herein provides a low-cost solution for adding smart functions to drug delivery devices, such as syringes or self-injectors (e.g., pen-type self-injectors or wearable ones), which are often used in the self-administration injection business. An example of an embodiment described herein uses an indicator on a drug delivery device, whereby the indicator becomes variable, i.e., the indicator is physically changed or the captured image of the indicator or the scan of the indicator is changed in response to a change in the state of the drug delivery device.

[0041] Examples of indicators include, but are not limited to, barcodes or other labels or patterns that can be scanned or otherwise recognized by different techniques in several ways. The indicator can be, for example, a pattern such as a barcode, or an alphanumeric indicator (e.g., a measurement scale indicating a unit of measurement), or a color-coded indicator, or an indicator having one or more shapes. The indicator can, of course, provide information represented by a barcode when utilized with a fluid chamber of a drug delivery device and can be implemented as a temperature sensitive barcode that facilitates determining the temperature of the fluid. The indicator can be printed directly on a drug delivery device or on a label utilized on the drug delivery device or related components, or can be etched into the material of the administration device or related components.

[0042] According to an aspect of an example of an embodiment, the indicator on the drug administration device is variable, that is, the indicator on the drug administration device is changed according to a change in the operation or use state of the drug administration device. For example, during the use of the drug administration device, it can be changed by a part or component of the drug administration device, or by a change in color, or by a change in transparency (e.g., due to a change in the state of the drug administration device, the indicator and / or material used on the drug administration device is damaged, or otherwise the transparency of the indicator and / or material becomes lower), resulting in a barcode or pattern change from the illegibility of the indicator part.

[0043] Examples of an indicator scanner or an indicator reader include a smartphone, or a dedicated barcode scanner that is even lower in cost, or other optical detection devices such as a photometer for determining a change in the color of a material or the transparency of a material used as a guide for a state change of the drug administration device. The indicator reader can also be an image capture and processing device. In the examples described herein, a smartphone or an iPad, or a camera on other smart devices is used. For example, scanning a changed barcode on a syringe or pen-type syringe or wearable self-injector that is changed after use (e.g., after injection) can help a patient track injection information (e.g., dosage, date / time when administered, etc.) with a convenient app as further described below. The app can be a mobile phone app, or otherwise a set of computer-readable instructions within a software application provided on a smart device such as a smart display device (e.g., Google Nest Hub) or a similar device.

[0044] For example, according to an exemplary embodiment, a mobile phone equipped with an integrated digital camera can receive a camera image of an indicator on a drug administration device (e.g., an indicator changed by removing a needle cap or a pen cap, or an indicator changed after injection) taken in relation to a stage of device use, and analyze the indicator captured in the image to automatically determine information regarding the drug administration device represented by the indicator and record it in a memory. A software application (i.e., a mobile phone application) can be provided. For example, the indicator can include not only a variable indicator as an example of an embodiment, but also the type of drug indicated by a barcode, or an expiration date, or a type of pen needle, or other predetermined information, or the indicator can include only variable indicators. The application can be programmed to recognize the unchanged and changed forms of the variable indicator captured in the image and associate the captured variable indicator with a designated state or other meaning. By the application, an image of the unchanged variable indicator can be associated with the pre-administration state of the drug administration device, while an image of the indicator showing the change (e.g., partially blocked by a component of the drug administration device, or extended by another code attached on a component of the drug administration device, or a change in transparency or color) can be associated by the application with different states of the drug administration device, such as a partial administration state or a post-administration state, or the arrangement of a safety function after injection. The application can automatically record these detected states in a memory device together with a date and / or a timestamp, thereby facilitating the capture of medical event information related to the user's injections. The user only needs to take a photo of their drug administration device during injection, and the mobile phone processor and the application analyze the indicator in the captured image to determine and record the state of the drug administration device.

[0045] Examples of some embodiments of variable indicators on a drug administration device include, but are not limited to, the following:

[0046] 1. For example, a syringe is provided with an indicator (e.g., another pattern of a barcode) having lines or other marks provided at intervals with respect to the transparent material of the syringe barrel. When a syringe stopper or other mechanical part of the syringe moves behind the barcode, it obscures a specific part of the barcode or pattern, thereby changing the value or meaning of that barcode or pattern read by a reader or scanner, or a phone app.

[0047] 2. The barcode or other pattern is either covered or exposed as part of the syringe mechanism. For example, if a barcode is provided under the movable part of a safety syringe before filling, the barcode will appear after the safety shield is placed. Such a variable indicator provided in the safety function facilitates the tracking of the type of device and whether the safety function was properly placed after injection. Such information can be useful in a clinical setting for context-based training, compliance tracking of staff procedures, and supply replenishment.

[0048] 3. A temperature sensing barcode is added to a self-injection device to sense the drug temperature, which can be a useful parameter.

[0049] 4. Any two or all combinations of the above embodiments of the variable indicator can be provided in a drug administration device to facilitate the recording of injection event information such as which device was used, the date and time of injection, the state of the fluid (e.g., temperature), and whether the safety function was properly placed.

[0050] According to an example of an embodiment, medically The event image capture app 114 (FIG. 7) can be a stand-alone app on a smartphone 20 or other portable device with a camera (e.g., iPad), or can be provided as an extension of a digital health (DH) app for a smartphone or other connected smart device, as described herein. The medical event image capture app 114 uses an image of a variable indicator on a drug administration device to analyze and determine the state depicted for the drug administration device, and automates the recording of relevant information in a memory device (e.g., among the operating states, in particular, the date or time the image was captured, the dosage administered or remaining, the pre-administration or post-administration state in conjunction with the arrangement of safety features). Additional information from the captured medical product images can be used by different functions of the app to support various aspects of patient condition management, such as training, compliance tracking, dosage accuracy, and supply replenishment, for example.

[0051] FIG. 7 is a block diagram representing an exemplary device 20. Although device 20 is referred to as a smartphone, it is understood that device 20 can be a dedicated medical management device, or a device that captures indicator images, such as a camera, or other portable handheld device (e.g., iPad) equipped with a reader device 102. Device 20 includes a processor 100 and, in accordance with an exemplary embodiment, a medical event image capture app, along with other device data, images, and apps 114It includes a memory 108 that can store. The device 20 can have one or more wireless communication interfaces 112 such as, for example, a Near Field Communication (NFC) interface, a BLUETOOTH (registered trademark) - compliant wireless communication interface, and / or a cellular communication interface. The device 20 can also have various user interfaces such as, for example, one or more microphones 106, a touch screen 104, or another display device that generates a graphical user interface (GUI) screen such as the screen of a medical event image capture application 114, any keypad or other user input device (not shown), and an audio signal output device (e.g., a speaker or a buzzer) 110.

[0052] The medical event image capture application 114 is program code that provides operations for capturing an indicator and / or a drug administration device image and operations for processing the captured image. The operations for processing the captured image can (1) decode or otherwise identify artifacts and related information systems from the indicators and other image elements within the captured image, (2) automatically record data related to medical events in a convenient manner, such as, for example, removing the needle cover before dosing, moving the plunger for dosing or otherwise, the level of the medical fluid within the syringe, and the operation of the needle receptacle after dosing when applicable, and (3) perform human - machine interaction (HMI) operations or other logical operations that alert the user regarding the selected information system, and request input or otherwise educate the user about the related medical event. in It can record, and (3) perform human - machine interaction (HMI) operations or other logical operations that alert the user regarding the selected information system, and request input or otherwise educate the user about the related medical event.

[0053] For example, the image capture operation captures an image from the device camera 102. The processing operation of the captured image can implement a two-dimensional (2D) and / or three-dimensional (3D) image processing algorithm to detect artifacts selected from the captured image. The processing operation of the captured image can optionally include recognition operations such as, for example, a QR code reader, a barcode reader, or a UPC code reader within the app 114, or an optical character recognition (OCR) operation. The HMI or other operations of the medical event image capture app 114 determine the state of the imaged drug administration device from the detected artifacts (e.g., variable indicators and other aspects of the imaged drug administration device), and record the relevant information system in the digital memory device.

[0054] Many patients administer the medications prescribed to them using low-cost and mostly disposable administration devices such as, for example, syringes or pen-type autoinjectors, or wearable autoinjectors (e.g., Libertas™ available from Becton, Dickinson and Company). As shown in FIG. 1, a typical syringe 10 is made primarily of plastic or glass and has several components including a barrel 30, a stopper 32, a plunger 34, and a needle 36. In order to enable proper dosing, graduations can be printed on the barrel. Inside the barrel 30, a rubber stopper 32 forms a seal that seals and transfers liquid medication or other fluids into and out of the barrel. The plunger 34 interacts with the rubber stopper 32 to move the rubber stopper 32 back and forth under the control of the user. A metal needle 36 or cannula is typically attached to the distal end of the barrel so that fluid can be injected into or removed from the body, although this is not always the case. For example, a syringe having a male Luer connector at its distal end can be attached to a female Luer connector on a catheter or an IV line to inject or draw in fluid without using a needle or cannula. Many syringes can be used by patients in hospitals and medical settings, as well as for relatively short periods of time for the management of certain medical conditions. The needle can be removably connected to the barrel using a Luer-Lok™ connection or a Luer slip connection 40, or it it is can be attached to the barrel in a non-removable way, or “staked,” during syringe manufacture

[0055] Syringe 10 can often be used with one or more components such as, for example, a needle shield 12 or a needle hub 14. An exemplary needle shield 12 is shown in FIG. 3 and is generally removed prior to injection.

[0056] Figures 2A, 2B, 2C, and 2D show a typical needle receptacle 14 for syringe 10, which is designed to retract the syringe after drug administration and cover the syringe needle within cavity 56 of the needle receptacle 14. The needle receptacle 14 includes a body 46 having a cavity sized to receive a guard body plunger 54. Similarly, the guard body plunger 54 has a cavity 56 sized to receive a pre-filled syringe 10. The plunger 54 is slidable within the body 46 cavity. The body 46 has a body inspection window 48 for viewing the plunger and syringe therein, its distal end part a spring 50, and its proximal end part has flanges 52a, b for resting a user's finger. The guard body plunger 54 has, at its proximal end part an opening 58 for receiving the distal end of syringe 10, and at its distal end part has an opening 60 through which a syringe needle with a shield protrudes. of the guard body plunger 54 Distal end part The perimeter is adjacent to spring 50. The guard body plunger 54 also has, at its proximal end part prongs 62a, b which form a recess for receiving the proximal end of syringe plunger 34 when positioned.

[0057] Reference is now made to FIGS. 3, 4A, 4B, 5 and 6, which illustrate an example of an embodiment of an improved syringe 10, needle shield 12, and needle receiver 14, each using a variable indicator, and as a result, provide a low-cost solution to the technical problem of enabling a user to more easily record injection event data involving a relatively low-cost drug administration device, and provide a low-cost solution for enabling the collection of other relevant data related to injection events. For example, the variable indicator is provided directly on the syringe 10 and / or on a related component such as, for example, the needle shield 12 or the needle receiver 14, or is utilized as a label, and the variable indicator is cited as a solution at a relatively low cost compared to other methods for collecting injection information such as, for example, RFID tags or sensors, or providing a processor and a communication interface on the syringe and the autoinjector.

[0058] Figure 3 shows an improved syringe 10 according to an example of an embodiment having a variable indicator 80 on the barrel 30 of the syringe 10. Although the indicator 80 is shown as a barcode, it may be, for example, a different optical pattern. The indicator 80 can represent a first state when it has not been changed (e.g., before drug administration). When the plunger 34 is disposed, the plunger stopper 32 changes the indicator 80 such that at least a portion of the indicator 80 is made unreadable so that a reader or scanner can read the change. This changes the indicator 80 that can be assigned by the app 114 to represent various states (e.g., post - administration state, or current dosage state, or fluid remaining state). Alternatively, the plunger 34 can comprise a second indicator 82, and a combination of it with the indicator 80, or an addition of it to the length of the indicator 80, or other means of changing the indicator 80 can represent different assigned states. The second indicator 82 may be, for example, another barcode, or another type of mark 84 on the plunger or stopper as shown in FIG. 5. The syringe 10 can optionally be used with an improved needle shield 12 having a variable indicator 86. When the shield 12 is removed from the syringe 10 and the indicator 86 is changed (e.g., shortened), the indicator 86 can be provided on a label where a portion of it is peeled off, and thus can represent a different state, e.g., an "injection event", as compared to the state of the pre - injection event represented by the unchanged indicator 86. When a change in the indicator 86 is detected, a timestamp corresponding to the "injection event" may be saved. In other words, to automatically detect and record when an injection was given using the app 114, the user only needs to take a photo of the shield 12 removed from the syringe. FIG. 5 illustrates a drug administration device with a variable indicator having a captured image of the variable indicator using the camera 102 on a smartphone 20 equipped with the app 114. It should be understood that the drug administration devices shown in FIGS. 3, 4A, 4B and 6 can similarly be read by the smartphone camera 102 or other types of scanners.

[0059] Figures 4A and 4B and FIG. 5 illustrate an improved syringe 10 with a needle receptacle 14 having a variable indicator, according to an example embodiment. The variable indicator can comprise a first indicator 88 on the needle receptacle body 46 and a second indicator 90 on the needle receptacle plunger 54. The first indicator 88 is unchanged in FIG. 4A and can represent the pre - administration state, and the first indicator 88 is changed (e.g., combined and lengthened) when the syringe needle is retracted into the needle receptacle original book body 46, and thus will represent the post - administration state. Either state can be detected using quick scan or image capture, and for example, the time and state are recorded via the app 114. Thus, the user is provided with another exemplary and convenient way to record injection events without the need to manually write or enter the date / time and other information.

[0060] The benefits of the variable code are not limited to syringes and their associated components, but can also be applied to pen - type self - injectors 18 and wearable self - injectors. For example, many patients use a relatively low - cost, disposable, pre - filled pen - type self - injector for one patient to administer medications. For example, many diabetic patients use, by way of example, a pen - type self - injector containing 300 units of insulin, and the patient can inject themselves one or more times with the pen 18. Referring to FIGS. 6A and 6B, the pen - type self - injector 18 comprises a pen body 64 with a cap 65, a dosage dial, and a window aperture 70. To inject, the user removes the cap 65 and connects the needle 68 to the pen 18. The pen 18 has a chamber 72 containing fluid (e.g., having a pre - filled or inserted fluid cartridge therein) and printed graduations 74 by which the user can visually identify the number of units of fluid in the chamber 72. The pen 18 further comprises a drive mechanism 76 that controllably discharges fluid from the chamber 72 through the needle 68 in accordance with the setting of the dosage dial 70.

[0061] Pen 18 is improved with low-cost variable indicators, enabling the user to record injection events associated with pen 18 in a convenient manner and at low cost. For example, chamber 72 can be provided with variable indicator 96, such as a barcode or other pattern as an example. When the drive mechanism 76 is fully retracted, the variable indicator 96 remains unchanged and is assigned by app 114 to represent the pre-dose state. After pen 18 is used for injection, stopper 78 on drive mechanism 76 blocks at least a portion of variable indicator 96 to change it and represents a different state. For example, the processor 100 can analyze only the variable indicator 96 captured in the camera image to determine the administered dosage and the fluid remaining in chamber 72 and automatically record such information in digital memory, or the variable indicator 96 with the physical characteristics of chamber 72 (e.g., the position of the stopper therein or the position of the stopper relative to scale 74).

[0062] Furthermore, the needle 68 can be packaged as a needle adapter 66 with an outer cover 67 having a peel label 69 that wraps around the needle 68 with the inner cover 63. Continuing to refer to FIGS. 6A and 6B, the variable indicator 92 can also be applied to the pen cap 65 and the body 64 by shortening the variable indicator 92 when the pen cap is removed. Alternatively, the variable indicator 94 can be provided on the outer cover 67 and the label 69 by shortening the variable indicator 94 when the label 69 is peeled off. In either case, the user can conveniently record the injection event by taking a picture of the changed variable indicator 92 or 94 before injection. Additionally, the variable indicator 92 or 94 can also be provided with barcode data indicating the type of pen and the type of needle that can also be recorded in digital memory.

[0063] The set of commands can implement a subset of the operations illustrated in FIG. 8. For example, steps 120-126 can be commands to capture an image of one or more variable codes or other indicators on the drug delivery device, commands to capture another image of one or more variable codes on the drug delivery device at different times, and commands to analyze the captured images to determine each of the operating phases of the drug delivery device based on any detected changes in the variable codes between the images and optionally provide a time and / or date stamp for each of the determined phases. To show exemplary phases detected for an exemplary syringe 10 used alone or in combination with one or both of the needle shield 12 and the needle receptacle 14, and to show exemplary phases detected for a related exemplary information system that can be generated from images of variable indicators on one or more syringes 10, needle shields 12, and needle receptacles 14, other exemplary operations are shown in FIG 8 as illustrated in

[0064] FIG. 8 illustrates an exemplary operation of a smartphone 20 or other device (e.g., a dedicated scanning device or iPad) operating in accordance with the medical event image capture application 114. It should be understood that an example of an embodiment can comprise computer-readable instructions for implementing a subset of the operations illustrated in FIG. 8. For example, steps 120-126 can be the main operations (blocks 120 and 124) of instructions to capture an image of a drug administration device with one or more variable codes or other indicia, analyze the captured image to identify the indicia and any associated attributes (block 122), and process the indicia and any associated attributes to determine, for example, an information system or content specified to associate the detected change indicia with the state assigned to the drug administration device (block 126). The other exemplary operations 128-148 illustrated in FIG. 8 show exemplary stages detected for an exemplary syringe 10 used alone or in combination with one or both of the needle shield 12 and needle receptacle 14, and exemplary stages detected for an associated exemplary information system that can be generated from images of variable indicia on one or more syringes 10, needle shields 12, and needle receptacles 14. It should be understood that the instructions can control other operations regarding detecting one or more states of the pen-type autoinjector.

[0065] For example, for block 126, the computer-readable instructions in app 114 can be configured to store information that assigns a state or operation of a different drug administration device to each of the corresponding unchanged variable indicators, and for example, the pre-administration state assigned to the unchanged variable indicator, and the post-administration state assigned to the indicator captured in the image and having any obfuscation of the indicator pattern for each stage of one or more changed variable indicators. As another example, app 114 can be configured to assign a first drug administration device state to the unchanged variable indicator and a second drug administration device state to the form of the changed variable indicator, whereby the indicator is lengthened (in combination with other indicators), or truncated, or the color or transparency of the indicator changes. App 114 can also be within a pen-type self-injector or a wearable self-injector and process the captured image of the syringe barrel or window adjacent to the variable indicator to determine the amount of fluid remaining, or the dosage currently adjusted by turning the dial in the syringe or the amount drawn into the syringe, or the dosage administered.

[0066] Continuing to refer to the exemplary operations 128-148 of FIG. 8, the user operates a smartphone 102, or other device equipped with a camera and app 114, to take an image of a drug administration device having a variable indicator at a selected point or stage of an injection event, such as after removal of the pen cap or needle cap, or immediately before administration, or immediately after movement of the plunger, or after deployment of the safety feature (block 120). The captured image processing operation of app 114 is the finger inker mer 102, or other device equipped with a camera and app 114 to take an image of a drug administration device having a variable indicator at a selected point or stage of an injection event, such as after removal of the pen cap or needle cap, or immediately before administration, or immediately after movement of the plunger, or after deployment of the safety feature. The captured image processing operation of app 114 is the standard Call and optionally analyze other attributes of the drug delivery device (blocks 122 and 124). The app 114 is configured to control the processor 100 to determine the state of the drug delivery device and optionally other related device information (block 126). For example, the processor 100 according to the app 114 determines whether the syringe needle shield 12 has been removed (block 128), and as described in connection with FIG. 3, indicates the start of an injection event based on an indicator on the shield that is changed or altered by the removal of the shield, and can record a corresponding timestamp therefor (blocks 130 and FIG. 9A). Similarly, as described in connection with FIGS. 3, 4A, 4B, 5, 6A, and 6B, the processor 100 determines whether the syringe plunger or the auto-injector drive mechanism has moved based on an indicator on the syringe barrel or the window of the auto-injector that has been changed or obscured, respectively, by the plunger stopper or the auto-injector drive mechanism (block 132), and as a result can record a corresponding timestamp (block 134).

[0067] Continuing to refer to FIG. 8, the processor 100 is controlled by the medical event image capture app 114 to determine whether the correct dosage has been withdrawn or administered, and if not, optionally provides an alert or a GUI screen to the user (blocks 136 and 138 and FIG. 9B). If a needle receptacle is used, the processor 100 can detect, for example, as described in connection with FIGS. 4A and 4B, whether this safety feature is properly positioned after injection using the first and second indicators, and optionally provides an alert or a GUI screen to notify the user of any problems or malfunctions (blocks 140 and 142 and FIG. 9D). The administered dosage is optionally passed through blocks 144 and FIG. 9C (e.g., a touch screen 104It can be confirmed as being administered via the GUI screen generated by the upper application 114. Medical event data or information systems (for example, among the data obtained via the captured image processing operations of the application 114, in particular, one or more confirmed dosages, detected malfunctions, operations of the drug administration status) can be stored on-site or remotely for access and use by the patient and / or other stakeholders in patient and / or condition management (block 146). For example, the medical event data or information system can be automatically uploaded to a repository for inclusion in the patient's electronic record, for medical billing, for automatic replenishment of medical supplies, and / or for tracking compliance with the care plan, especially in uses (block 148) such as being incorporated into an integrated disease management system by way of example.

[0068] Exemplary embodiments disclose multiple ways to better engage with the user and leverage the strengths from both the drug administration device and the medical event image capture application 114 to improve the user experience. The application 114 is also used to recognize both specific functions and activities, to confirm that they are as intended, to have the user confirm, and to enable the recording and tracking of information for future generations. Overall, the integrated use of the variable indicator and the drug administration device with the application 114 can promote better compliance and improved patient outcomes. For example, according to the exemplary embodiments described herein, the recording of injection events and related information such as, for example, the dosage administered becomes a more convenient way, which in turn can provide more accurate data for better clinical decision-making. Although mainly targeted at the self-injecting patient base, the combination of the application 114 and the drug administration device with the variable indicator can also be utilized in other environments (such as in a facility location and alternative locations) and by caregivers (such as nurses, family members, etc.).

[0069] The terms "comprising", "including", "having", and / or "containing", as used within this specification, are intended to specify the presence of the stated feature, integer, step, operation, element, and / or component, but are not intended to preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and / or groups thereof.

[0070] The terms "first", "second", "third", etc. may be used herein to describe various elements, components, regions, layers, and / or sections, but it is further understood that these elements, components, regions, layers, and / or sections are not limited to these terms. These terms are only used to distinguish one element, component, region, layer, or section from another.

[0071] 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 coming before the recited elements change the recited elements as a whole and not the recited individual elements. Further, terms such as "unit", "-er (-or)", and "module" as described herein refer to an element that performs at least one function or operation and can be implemented in hardware, software, or a combination of hardware and software.

[0072] Various terms are used to refer to specific system components. Different companies may refer to components by different names. - This document is not intended to distinguish components that have different names but the same function.

[0073] The content of an example of these embodiments, which will be apparent to those skilled in the art to which an example of these embodiments pertains, may not be described in detail herein.

[0074] The components of the exemplary devices, systems, and methods used in accordance with the illustrated embodiments described herein can be implemented at least in part 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, tangibly embodied in an information carrier or a machine-readable storage device, for execution by, or to control the operation of, a data processing apparatus such as a programmable processor, a computer, or multiple computers.

[0075] A computer program can be written in any form of programming language, including compiled languages or interpreted languages, and it can be arranged in any form, including a stand-alone program suitable for use in a computer environment, or a module, component, subroutine, or other unit. The computer program can be placed on one computer or other device, or distributed across multiple devices in one location or multiple locations and connected by a communication network for execution. Also, function programs, code, and code segments for performing the features described herein can be easily developed by a programmer skilled in the art. The steps of a method related to an example of an embodiment can be performed by one or more programmable processors that execute a computer program, code, or instructions for performing the function (e.g., by manipulating input data and / or by generating output). Similarly, the steps of a method can be performed by dedicated logic circuits, such as, for example, a field programmable gate array (FPGA) or an application specific integrated circuit (ASIC), and the devices described herein can be implemented as dedicated logic circuits, such as, for example, a field programmable gate array (FPGA) or an application specific integrated circuit (ASIC).

[0076] The various logic blocks, modules, and electrical circuits described as examples in connection with the embodiments described herein can be implemented or embodied in a general-purpose processor, digital signal processor (DSP), ASIC, 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. The general-purpose processor may be a microprocessor, but in the alternative, the processor may be any conventional processor, controller, microcontroller, or state machine. Similarly, the processor may be implemented as a combination of computer devices, such as, for example, 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.

[0077] Processors suitable for the execution of a computer program include, by way of example, both general and special purpose microprocessors, as well as any one or more processors of any kind of digital computer. In general, 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. In general, a computer also includes, or is operatively coupled to, one or more mass storage devices for data storage, such as, by way of example, magnetic disks, magneto-optical disks, or optical disks, for receiving data from, or transmitting data to, or both, one or more mass storage devices. 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, which include, by way of example, electric programmable read only memory (ROM) (EPROM), electrically erasable programmable ROM (EEPROM), flash memory devices, and data storage disks (such as, magnetic disks, internal hard disks, or removable disks, magneto-optical disks, and CD-ROM, and DVD-ROM disks). The processor and the memory can be supplemented by, or incorporated in, dedicated logic circuitry.

[0078] A 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 should be understood that software can be sold by being installed on a central processing unit (CPU) device. orSoftware can be obtained and loaded onto the CPU device, which includes obtaining the software through a physical medium or distribution system, for example, from a server owned by the software creator or from a server not owned by but used by the software creator. The software can be stored on a server for distribution, for example, on the Internet.

[0079] It can be understood that an example of the embodiments described in this specification can be considered only for illustrative purposes and not for the purpose of limitation. The description of features or aspects within the scope of an example of each embodiment can be regarded as applicable to other similar features or aspects in an example of other embodiments. Although the exemplary embodiments are described with reference to the figures, those skilled in the art will understand that various changes in form and detail can be made therein without departing from the spirit and scope defined by the following claims.

Claims

Claim 1 A medical administration system, comprising a drug administration device selected from the group consisting of a syringe, a pen-type self-injector, and a wearable self-injector, the drug administration device having a variable indicator that is changed after a specified operation related to the drug administration device, the specified operation being selected from the group consisting of removal of a pen cap, or removal of a needle cap, movement of a plunger, or movement of another drive mechanism for supplying fluid from the drug administration device, mechanical movement of components of the drug administration device, and movement of drug administration device components after the fluid has been supplied; a set of computer-readable instructions for analyzing an image of the variable indicator and assigning a first state of the drug administration device when the analysis of the image detects that the variable indicator is unchanged, assigning a second state of the drug administration device when the analysis of the image detects that the variable indicator has been changed by the specified operation related to the drug administration device, and storing the assigned state in a memory device; comprising wherein the syringe comprises a needle shield removably attached to the syringe, the needle shield being configured to expose the needle after the needle shield is removed, the variable indicator being configured to be changed by removal of the needle shield from the syringe, the first state of the syringe being the needle shield attached to the syringe, and the second state of the syringe being the needle shield removed from the syringe. Claim 2 The medical administration system according to claim 1, wherein the needle shield is configured to cover the needle before the needle shield is removed, and the variable indicator is provided on the needle shield. Claim 3 The medical administration system according to claim 2, wherein the set of computer-readable instructions is configured to communicate the determined first state of the needle shield attached to the syringe to another device, or to communicate the determined second state of the needle shield removed from the syringe to another device. Claim 4 The medical administration system according to claim 2, wherein the variable indicator is provided on the syringe, as the printed label that is attached to the syringe and is detachable from the syringe when removing the needle shield from the syringe, and is operable on a part of the printed label that changes the variable indicator by being detached.

5. The medical administration system according to claim 2, wherein when the needle shield is attached to the syringe to represent the first state of the syringe, the needle obscures at least a part of the variable indicator, and when the needle shield is removed from the syringe to represent the second state of the syringe, the variable indicator is not obscured by the needle.

6. A medical administration system, a drug administration device selected from the group comprising a syringe, a pen-type self-injector, and a wearable self-injector, the variable indicator being changed after a specified operation related to the drug administration device, the specified operation being selected from the group consisting of removal of a pen cap, or removal of a needle cap, movement of a plunger, or movement of another drive mechanism that supplies fluid from the drug administration device, mechanical movement of parts of the drug administration device, and movement of parts of the drug administration device after the fluid has been supplied; and a set of computer-readable instructions that analyze an image of the variable indicator, assign a first state of the drug administration device when the analysis of the image detects that the variable indicator is unchanged, assign a second state of the drug administration device when the analysis of the image detects that the variable indicator has been changed by the specified operation related to the drug administration device, and store the assigned state in a memory device. comprising The drug administration device is a syringe, and the variable indicator comprises at least a first indicator provided on the syringe. The syringe includes a barrel having a cavity for holding a fluid, an opening at a proximal end of the syringe for receiving a plunger, an opening at a distal end of the syringe for connection with a fluid needle, and a plunger movable within the cavity of the barrel, the plunger having a stopper on its distal end. The set of computer-readable instructions analyzes an image of the first indicator and assigns the first state to the syringe when the analysis of the image detects that the first indicator is invariant, and when the analysis of the image detects that the first indicator has been changed by the movement of the plunger, the set of computer-readable instructions assigns the second state to the syringe. A needle receiver comprising a needle receiver plunger having a plunger cavity for at least partially receiving the syringe, and a body having a body cavity for at least partially receiving the needle receiver plunger. The needle receiver plunger has an opening at a proximal end thereof for receiving the syringe within the plunger cavity, and an opening at a distal end of the needle receiver plunger through which the needle of the syringe extends through the distal end in a pre-administration state. The body has a spring mechanism at a distal end of the body for energizing the distal end of the needle receiver plunger during the pre-administration state. The spring mechanism is operable in a released energy state for advancing the needle receiver plunger and the syringe toward a proximal end of the body to retract the needle of the syringe into the body after the syringe has completed fluid administration from the syringe. The first indicator provided on the syringe is invariant during the pre-administration state and is changed after the spring mechanism has advanced the needle receiver plunger and the syringe to retract the needle into the body. A medical administration system further comprising a needle receiver. Claim 7 The medical administration system according to claim 6, wherein the body comprises a window through which the first indicator on the syringe is visible. Claim 8 The variable indicator can comprise a second indicator, and at least one of a stopper and the second indicator on the plunger or the second indicator on the stopper is provided on the plunger of the syringe, and the first indicator is at least partially blocked by the stopper, and the first indicator is at least partially blocked by the second indicator, and the first indicator and the second indicator are combined within the image representing the second state of the syringe. When a situation selected from the above occurs, when the first indicator is changed by the movement of the plunger, the analysis of the image detects it. The medical administration system according to claim 6.

9. The analysis of the image uses a combination of the first indicator and the second indicator to detect that the spring mechanism has advanced the needle receiving plunger and the syringe to retract the needle into the main body. The medical administration system according to claim 8.

10. The variable indicator can comprise a second indicator, the second indicator is provided on the needle receiving plunger of the syringe, and the analysis of the image uses a combination of the first indicator and the second indicator to detect that the spring mechanism has advanced the needle receiving plunger and the syringe to retract the needle into the main body. The medical administration system according to claim 6.

11. The analysis of the image determines whether the combination of the first indicator and the second indicator comprises a changed indicator having a length increased from the first indicator or the second indicator. The medical administration system according to claim 10.

12. The set of computer-readable instructions is configured to communicate to another device a determined first state corresponding to the syringe being invariant during the pre-administration state, or a determined second state corresponding to advancing the needle receiving plunger and the syringe to retract the needle into the main body. The medical administration system according to claim 6.

13. A medical administration system, A drug administration device selected from the group consisting of a syringe, a pen-type self-injector, and a wearable self-injector, comprising a variable indicator that is changed after a specified operation related to the drug administration device, the variable indicator being selected from the group consisting of removal of the pen cap, or removal of the needle cap, movement of the plunger, or movement of another drive mechanism that supplies fluid from the drug administration device, mechanical movement of parts of the drug administration device, and movement of the drug administration device parts after the fluid has been supplied. A set of computer-readable instructions that analyzes an image of the variable indicator, assigns a first state of the drug administration device when the analysis of the image detects that the variable indicator is unchanged, assigns a second state of the drug administration device when the analysis of the image detects that the variable indicator has been changed by the specified operation related to the drug administration device, and stores the assigned state in a memory device. Comprising A syringe holder comprising a plunger for at least partially accommodating a syringe and having a plunger cavity, and a body having a body cavity for at least partially accommodating the syringe holder, wherein the syringe holder has, at a proximal end portion of the syringe holder, an opening for accommodating the syringe in the plunger cavity, and at a distal end portion of the syringe holder, an opening through which a needle of the syringe extends through a distal end portion in a pre-administration state, the body having, at the distal end portion of the body, a spring mechanism for bringing the distal end portion of the syringe holder into an energy storage state during the pre-administration state, the spring mechanism being operable in a released energy state for advancing the syringe holder and the syringe toward a proximal end portion of the body for retracting the needle of the syringe into the body after the syringe has completed fluid administration from the syringe, the variable indicator comprising a first indicator provided on the body and a second indicator provided on the syringe holder, the variable indicator being assigned the first state by the set of instructions during the pre-administration state, and the variable indicator being assigned a second state when the variable indicator is changed after the spring mechanism has advanced the syringe holder and the syringe to retract the needle into the body, the medical administration system further comprising a syringe holder.

14. A medical administration system, a drug administration device selected from the group comprising a syringe, a pen-type self-injector, and a wearable self-injector, the drug administration device comprising a variable indicator that is changed after a specified action related to the drug administration device, the specified action being selected from the group consisting of removal of a pen cap, or removal of a needle cap, movement of a plunger, or movement of another drive mechanism for supplying fluid from the drug administration device, mechanical movement of components of the drug administration device, and movement of drug administration device components after the fluid has been supplied. A set of computer-readable instructions that analyzes an image of the variable indicator, assigns a first state of the drug administration device when the analysis of the image detects that the variable indicator is invariant, assigns a second state of the drug administration device when the analysis of the image detects that the variable indicator has been changed by the specified operation regarding the drug administration device, and stores the assigned state in a memory device. comprising The drug administration device is a pen-type autoinjector, and at least one of a pen cap removably attached to the pen-type autoinjector, a needle removably attached to the pen-type autoinjector, a dosage window through which fluid for administration and a drive mechanism configured to discharge the fluid from the pen-type autoinjector are visible, and a fluid cartridge if the pen-type autoinjector is reusable is provided with the variable indicator. The variable indicator is provided on or adjacent to the body of the pen-type autoinjector and on the dosage window, and the drive mechanism has a rubber seal at its distal end that is moved to supply the fluid, and the set of computer-readable instructions analyzes one or more images of the variable indicator and assigns the first state to the drug administration device when the analysis of the one or more images detects that the variable indicator is invariant, and the variable indicator is at least partially blocked by the rubber seal, and there is a change in the position of the blocked portion of the variable indicator by the rubber seal, and there is a change in the variable indicator related to a measurement scale provided on the dosage window or adjacent to the body due to at least one of fluid supply or movement of the rubber seal, and assigns the second state to the drug administration device when the analysis of the one or more images detects a situation selected from the group consisting of, and the set of computer-readable instructions processes the captured image of the dosage window and is configured to determine a dosage adjusted by turning a dial or the dosage administered. A medical administration system.

15. A medical administration system, A drug administration device selected from the group comprising a syringe, a pen-type self-injector, and a wearable self-injector, the movement of the plunger, or the movement of another drive mechanism that supplies fluid from the drug administration device, the mechanical movement of the components of the drug administration device, and the movement of the components of the drug administration device after the fluid is supplied, and having a variable indicator that is changed after a specified operation related to the drug administration device. A set of computer-readable instructions that analyzes an image of the variable indicator, assigns a first state of the drug administration device when the analysis of the image detects that the variable indicator is unchanged, assigns a second state of the drug administration device when the analysis of the image detects that the variable indicator has been changed by the specified operation related to the drug administration device, and stores the assigned state in a memory device. Comprising The first state of the drug administration device is a pre-administration state, and the second state of the drug administration device is selected from the group consisting of an administration started by the movement of the mechanical movement of the components of the drug administration device and an administration completed by the movement of the mechanical movement of the components of the drug administration device to an end position. The set of computer-readable instructions is configured to determine the state of the drug administration device, which is selected from the group consisting of the distance the components of the drug administration device move, the amount of fluid remaining in the drug administration device, and the amount of fluid administered from the drug administration device by the movement of the components of the drug administration device, from the changed variable indicator.

16. The medical administration system according to claim 15, wherein the set of computer-readable instructions stores in the memory device, each associated with a time stamp corresponding to the assigned state.

17. The medical administration system according to claim 15, wherein the set of computer-readable instructions is within a software application stored in the memory of a digital device, and the image is generated by a camera associated with the digital device.

18. The medical administration system according to claim 15, wherein the variable indicator comprises one or more characteristics selected from the group consisting of a machine-readable code, a bar code, a printed indicator, an etched indicator, an alphanumeric indicator, a color-coded indicator, an optical indicator, an indicator indicating a measurement scale, an indicator having one or more stripes, and an indicator having one or more shapes.

19. The medical administration system according to claim 15, wherein the variable indicator is changed by an operation selected from extending the variable indicator, shortening the variable indicator, changing an optical characteristic of the variable indicator, and changing a physical characteristic of the variable indicator.

20. The medical administration system according to claim 1, wherein the set of computer-readable instructions is configured to communicate the determined first state or the determined second state to another device.

Images