Systems, apparatus, and methods for capturing images of events related to medical condition management.

Abstract

A drug delivery device system with variable markers and a method of using the same are provided. The drug delivery device system includes a syringe and / or syringe assembly (e.g., needle shield, needle cap), or an auto-injector pen, or a wearable auto-injector with variable markers, and a software application for an external device to analyze images of the variable markers to automatically determine and record the status of the drug delivery device. The variable markers or codes on the drug delivery device or its components represent various medical events, such as dose completion, dose amount, and deployment or removal of safety features, and can be detected and otherwise recorded by an external device. The external device can execute an application configured to further process data obtained via captured images of the variable markers and display relevant information (e.g., fluid remaining in the syringe barrel, delivered dose, etc.).

Description

[0001] Cross-reference to related applications

[0002] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63 / 017,347, filed April 29, 2020, the entire contents of which are incorporated herein by reference. Technical Field

[0003] The apparatuses and methods consistent with the example embodiments relate to drug delivery devices, such as syringes, autoinjector pens, and wearable autoinjectors for transferring (i.e., injecting or withdrawing) fluids, and more particularly, to syringes and / or related components (e.g., syringe needle shields and guards), or autoinjector pens, or wearable autoinjectors with variable markers for providing information about the status of the syringe or syringe assembly (e.g., use or stage of use), or the autoinjector, or the filler volume, or the dose delivered, and other information, as well as smartphone applications (apps) that facilitate the capture and transmission of information. 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 (i.e., smart pen injectors) 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 devices 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 track compliance with health condition management agreements or programs, improve related processes such as medical supply replenishment, prevent medical errors such as medication delivery errors, and facilitate information sharing among health condition management stakeholders for purposes such as optimal patient care treatment planning, billing, and insurance coverage.

[0008] Effective administration of some types of injectable medications, particularly in diabetic patients using insulin, requires recording all doses. Many patients use low-cost and often disposable delivery devices, such as syringes or auto-injector pens, to deliver their prescription medications. While these devices are relatively simple to use, they often lack any features to help patients or healthcare professionals record their use in relation to adherence to their medication regimen.

[0009] For example, patients are encouraged to record the date, time, and amount of self-injection using a syringe or auto-injector pen. While patients are educated about self-injection, most still find it challenging to correctly follow instructions daily. Furthermore, the only way to obtain a record of injections and dosages is by manually recording them. Additionally, some patients may find it difficult to draw a very specific amount of medication into the syringe and / or determine the specific amount of medication injected due to difficulty reading the graduations on the syringe barrel or correctly following the instructions.

[0010] Difficulties in recording injection information via syringes and auto-injector pens can also arise in clinical settings. For example, while healthcare professionals are better trained than patients to record dosage-related information, the associated costs of obtaining this information are significant. In clinical settings with multiple patients, measuring and recording certain injection times and doses can be challenging in terms of both time and convenience. Summary of the Invention

[0011] The example embodiments can solve at least the problems and / or disadvantages described above, as well as other disadvantages not described above. Furthermore, the example embodiments do not need to overcome the above-described disadvantages, and may not overcome any of the above-described problems.

[0012] There is a need for an improved drug delivery device that can provide users with more convenient, consistent, and accurate capture of information about injection events and delivery doses to improve adherence to prescription drug dosing regimens.

[0013] According to an example embodiment, a medical delivery system includes a drug delivery device selected from syringes, autoinjector pens, and wearable autoinjectors. The drug delivery device has a variable marker that is changed after a drug-designated operation selected from removing a pen cap or needle cap, moving a plunger or other actuation mechanism to dispense fluid from the drug delivery device, mechanical movement of components of the drug delivery device, and movement of the drug delivery device components after fluid dispensing. The medical delivery system also includes a set of computer-readable instructions that analyze an image of the variable marker and assign a first state of the drug delivery device when the image analysis detects that the variable marker has not changed, assign a second state of the drug delivery device when the image analysis detects that the variable marker has changed due to the drug delivery device's designated operation, and store the assigned state in a memory device.

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

[0015] According to one aspect of an example embodiment, the set of computer-readable instructions is in 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 one aspect of an example embodiment, the first mark includes one or more characteristics selected from machine-readable codes, barcodes, printed marks, etched marks, alphanumeric marks, color-coded marks, optical marks, marks indicating measurement scales, marks including one or more stripes, and marks including one or more shapes.

[0017] According to one aspect of an example embodiment, the first mark is altered by an operation selected from extending the first mark, shortening the first mark, changing the optical properties of the first mark, and changing the physical properties of the first mark.

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

[0019] According to one aspect of an example embodiment, the drug delivery device is a syringe, and the variable mark includes at least a first mark disposed on the syringe. The syringe includes a barrel having a cavity for holding fluid, an opening at its proximal end for receiving a plunger, an opening at its distal end for fluid connection with a needle, and a plunger movable within the cavity of the barrel and including a stopper at its distal end. A set of computer-readable instructions analyzes an image of the first mark and assigns a first state to the syringe when the image analysis detects that the first mark has not changed, and assigns a second state to the syringe when the image analysis detects that the first mark has changed due to movement of the plunger.

[0020] According to one aspect of an example embodiment, the set of computer-readable instructions is configured to transmit the determined state of the syringe to another device.

[0021] According to one aspect of an example embodiment, the first state of the syringe is a pre-delivery state, and the second state of the syringe is selected from delivery initiated by moving the plunger and delivery completed by moving the plunger to the end position.

[0022] According to one aspect of an example embodiment, the set of computer-readable instructions is configured to determine the state of the syringe, the state being selected from the distance traveled by the plunger, the amount of fluid remaining in the syringe, and the amount of fluid delivered from the syringe due to the movement of the plunger.

[0023] According to one aspect of an example embodiment, the variable mark may include a second mark, and the plunger is provided with at least one of a stopper and a second mark on the plunger or the stopper. Image analysis detects that when a condition occurs selected from the following—that the first mark is at least partially obscured by the stopper, that the first mark is at least partially obscured by the second mark, and that the first mark and the second mark are combined in the image—the first mark is altered due to movement of the plunger to indicate a second state of the syringe.

[0024] According to one aspect of an example embodiment, the syringe includes a needle shield removably attached to the syringe, the needle shield being configured to cover the needle before removal and expose the needle after removal. A first mark is affixed to the needle shield and configured to change by removal of the needle shield from the syringe. A first state of the syringe is that the needle shield is attached to the syringe, and a second state of the syringe is that the needle shield is removed from the syringe.

[0025] According to one aspect of an example embodiment, the set of computer-readable instructions is configured to transmit either a first state in which the determined syringe is secured to the needle shield or a second state in which the determined needle shield is removed from the syringe to another device.

[0026] According to one aspect of an example embodiment, a first mark is disposed on the syringe as a printed label fixed to the syringe, and is operable to tear off a portion of the printed label from the syringe when the needle shield is removed from the syringe, thereby altering the first mark.

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

[0028] According to another aspect of the example embodiment, the medical delivery system further includes a needle shield. The needle shield has: a needle shield plunger having a plunger cavity that at least partially receives a syringe; and a body having a body cavity that at least partially receives the needle shield plunger. The needle shield plunger has an opening at its proximal end for receiving a syringe into the plunger cavity, and an opening at its distal end through which the needle of the syringe extends in a pre-delivery state. The body has a spring mechanism at its distal end that engages the distal end of the needle shield plunger in an energy-storing state during the pre-delivery state. The spring mechanism is operable in an energy-released state to push the needle shield plunger and syringe towards the proximal end of the body, thereby retracting the syringe needle back into the body after the syringe has completed delivery of fluid therefrom. A first mark on the syringe remains unchanged during the pre-delivery state and is changed after the spring mechanism pushes the needle shield plunger and syringe to retract the needle back into the body.

[0029] According to one aspect of an example embodiment, the body includes a window through which a first mark on the syringe can be seen.

[0030] According to one aspect of an example embodiment, the variable mark may include a second mark, and the plunger of the syringe is provided with at least one of a stopper and a second mark on the plunger or the stopper. Image analysis detects that when a condition occurs selected from the following—that the first mark is at least partially obscured by the stopper, that the first mark is at least partially obscured by the second mark, and that the first mark and the second mark are combined in the image—the first mark changes due to movement of the plunger to indicate a second state of the syringe.

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

[0032] According to one aspect of the example embodiment, the variable mark may include a second mark, and the plunger of the syringe is provided with the second mark. Image analysis employs a combination of the first and second marks to detect that the spring mechanism has advanced the needle guard plunger and the syringe to retract the needle back into the body.

[0033] According to one aspect of an example embodiment, image analysis includes determining whether the combination of a first marker and a second marker includes a modified marker whose length is increased compared to either the first marker or the second marker.

[0034] According to one aspect of an example embodiment, the set of computer-readable instructions is configured to transmit a determined first state corresponding to the syringe not changing during the pre-delivery state or a determined second state corresponding to advancing the needle guard plunger and syringe to retract the needle back into the body to another device.

[0035] According to one aspect of an example embodiment, a needle shield includes a needle shield plunger having a plunger cavity that at least partially receives a syringe, and a body having a body cavity that at least partially receives the needle shield plunger. The needle shield plunger has an opening at its proximal end for receiving the syringe into the plunger cavity, and an opening at its distal end through which the needle of the syringe extends in a pre-delivery state. The body has a spring mechanism at its distal end that engages the distal end of the needle shield plunger in an energy-storing state during the pre-delivery state, and is operable in an energy-released state to push the needle shield plunger and syringe towards the proximal end of the body to retract the syringe needle into the body after the syringe has completed delivery of fluid therefrom. A variable marking includes a first marking on the body and a second marking on the needle shield plunger, the variable marking being assigned to a first state by the set of instructions during the pre-delivery state, and assigned to a second state when changed after the spring mechanism pushes the needle shield plunger and syringe to retract the needle into the body.

[0036] According to one aspect of another example embodiment, the drug delivery device is an autoinjector pen, and variable markings are provided on at least one of a pen cap removably attached to the autoinjector pen, a needle removably attached to the autoinjector pen, a dose window visible through the fluid used for delivery and a drive mechanism configured to discharge fluid from the autoinjector pen, and a fluid cartridge if the autoinjector pen is reusable.

[0037] According to one aspect of another example embodiment, a variable marker is disposed on and adjacent to a dose window or the body of an auto-injector pen, and a drive mechanism has a rubber seal at its distal end that is translated to dispense fluid. The set of computer-readable instructions analyzes one or more images of the variable marker and, when the analysis of the one or more images detects that the variable marker has not changed, assigns a first state to the drug delivery device; and, when the analysis of the one or more images detects a condition selected from at least partially obscuring the variable marker by the rubber seal, a change in the position of the obscured portion of the variable marker by the rubber seal, and a change in the variable marker relative to a measurement scale disposed on or adjacent to the dose window due to at least one of fluid dispensing or movement of the rubber seal, assigns a second state to the drug delivery device. Attached Figure Description

[0038] The above and / or other exemplary aspects and advantages will become apparent and more readily understood from the following description of exemplary embodiments in conjunction with the accompanying drawings, in which:

[0039] Figure 1 illustrates an example syringe according to the relevant technology;

[0040] Figures 2A and 2B illustrate example needles according to the relevant technology, and Figures 2C and 2D illustrate the needle guards of Figures 2A and 2B, but with example syringes deployed therein;

[0041] Figure 3 An example syringe with variable markings according to an illustrative embodiment is shown;

[0042] Figure 4A and 4B An example needle guard with a syringe and variable markings according to an illustrative embodiment is shown;

[0043] Figure 5 An example image capture device according to an illustrative embodiment is illustrated, which generates... Figure 4A and 4B An image showing a syringe needle shield;

[0044] Figure 6A An example auto-injector pen and / or pen needle adapter with variable markings is illustrated according to an illustrative embodiment;

[0045] Figure 6B An example auto-injector pen with variable markings is illustrated according to an illustrative embodiment;

[0046] Figure 7 A block diagram of an example mobile phone having a medical event image capture application according to an illustrative embodiment is shown;

[0047] Figure 8 A flowchart illustrating the operation of a syringe with variable markings and external devices according to an illustrative embodiment; and

[0048] Figure 9A , 9B Figures 9C and 9D illustrate information that an application according to an example embodiment may result in being displayed on an external device. Detailed Implementation

[0049] Reference will now be made in detail to the exemplary embodiments illustrated in the accompanying drawings, where the same reference numerals refer to the same elements throughout. In this respect, the exemplary embodiments may take different forms and are not to be construed as limited to the description set forth herein.

[0050] The example embodiments described herein provide low-cost solutions for adding intelligent features to drug delivery devices such as syringes or autoinjectors (e.g., autoinjector pens or wearable devices), which are typically used in self-administered injection operations. The example embodiments described herein use markers on the drug delivery devices, whereby the markers are variable; that is, the markers are physically changed, or the captured image or scan of the markers is altered, depending on changes in the state of the drug delivery device.

[0051] Examples of markings include, but are not limited to, barcodes or other marks or patterns that can be scanned or otherwise identified using different technologies. For example, a marking can be a pattern such as a barcode, or an alphanumeric mark (e.g., a measurement scale indicating units of measurement), or a color-coded mark, or a mark comprising one or more shapes. The marking can be implemented as a temperature-sensitive barcode, which, when applied relative to the fluid chamber of a drug delivery device, can help determine the temperature of the fluid and provide the information represented by the barcode. The marking can be printed directly onto the drug delivery device or on a label applied to the drug delivery device or related components, or etched into the material of the delivery device or related components.

[0052] According to one aspect of the example embodiment, the markings on the drug delivery device are variable, i.e., they change depending on changes in the operation or use state of the drug delivery device. For example, the markings may be changed by variations in barcodes or patterns due to part of them being confused with a part or component of the drug delivery device, or by changes in color or transparency during use of the drug delivery device (e.g., changes in the state of the drug delivery device causing the markings and / or materials used on the drug delivery device to be scratched or otherwise less transparent).

[0053] Examples of marker scanners or readers are smartphones or lower-cost dedicated barcode scanners, or other optical detection devices, such as photometers used to determine changes in the color or transparency of materials used as indicators of changes in the status of drug delivery devices. Mark readers can also be image capture and processing devices. Examples described herein use cameras on smartphones, iPads, or other smart devices. For example, scanning altered barcodes on syringes, pen syringes, or wearable autoinjectors that have been modified after use (e.g., after injection) can help patients track injection information (e.g., dosage, date / time (if medication was administered), etc.) in a convenient application, as further described below. The application can be a mobile phone app or a set of computer-readable instructions within a software application available on a smart device such as a smart display device (e.g., Google Nest Hub) or a similar device.

[0054] For example, according to an illustrative embodiment, a software application (i.e., a mobile phone application) can be provided to a mobile phone with an integrated digital camera. This software application receives camera images of markings on a drug delivery device captured during device use (e.g., markings altered due to removal of a needle cap or pen cap, or markings altered after injection), and analyzes the markings captured in the images to automatically determine and record in memory information about the drug delivery device represented by the markings. For example, the markings may include predetermined information, such as the type of drug indicated in a barcode, or an expiration date or needle type, and variable markings as in the example embodiment, or the markings may include only variable markings. The application can be programmed to identify unchanged and altered forms of variable markings captured in the images and associate specified states or other meanings with the captured variable markings. The application can associate images of unchanged variable markings with the pre-delivery state of the drug delivery device, while images of markings indicating changes (e.g., partially obscured by drug delivery device components or extended by another combination code on the drug delivery device components, or changes in transparency or color) can be associated by the application with different states of the drug delivery device, such as partial delivery or post-delivery states, or the deployment of post-injection safety features. The application can automatically record these detected states, along with the date and / or timestamp, in the storage device, allowing users to easily capture information about medical events related to their injections. Users simply need to take a picture of their medication delivery device during the injection process, and the phone's processor and the application will analyze the markers in the captured image to determine and record the status of the medication delivery device.

[0055] Some example embodiments of variable markers on drug delivery devices include, but are not limited to:

[0056] 1. The syringe is marked (e.g., a barcode or other pattern) with lines or other markings spaced apart from the transparent material of the syringe barrel. When the syringe stopper or other mechanical parts of the syringe move behind the barcode, it obscures parts of the barcode or pattern, thereby altering the value or meaning of the barcode or pattern read by a reader, scanner, or telephone application.

[0057] 2. As part of the syringe mechanism, barcodes or other patterns may be covered or exposed. For example, if a barcode is provided under a removable section of a pre-filled safety syringe, it will be displayed after the safety shield is deployed. This variable marking on the safety feature helps track the device type and whether the safety feature was successfully deployed after injection. This information can be used in a clinical setting for context-based training, employee procedure compliance tracking, and supply replenishment.

[0058] 3. Add a temperature-sensing barcode to the self-injection device to sense the drug temperature, which can be a useful parameter.

[0059] 4. Any two or all combinations of the above embodiments of the variable marker can be provided to the drug delivery device to facilitate the recording of injection event information, such as which devices were used, the date and time of injection, the state of the fluid (e.g., temperature), and whether safety features were successfully deployed.

[0060] Based on an example embodiment, this document describes a medical event image capture application 114 ( Figure 7 This can be a standalone application on a smartphone 20 or other portable device with a camera (e.g., an iPad), or it can be provided as an enhancement to a digital health (DH) application on a smartphone or other smart connected device. The medical event image capture application 114 uses one or more variable-tagged images of the drug delivery device to automatically analyze and determine the imaging status of the drug delivery device and record relevant information in a memory device (e.g., pre- or post-delivery status, date or time of image capture, delivered dose or remaining amount, deployment of safety features, and other operational status). Different functions of the application can use additional information from captured medical product images to assist in various aspects of medical condition management, such as training, compliance tracking, dosage accuracy, and supply replenishment.

[0061] Figure 7 This is a block diagram depicting example device 20. Device 20 is referred to as a smartphone, but it should be understood that device 20 may be a dedicated medical management device or other portable handheld device (e.g., iPad) having a tag image capture or reader device 102, such as a camera. Device 20 includes a processor 100 and a memory 108, which may store medical event image capture application 114 according to the illustrative embodiment, as well as other device data, images, and applications. Device 20 may have one or more wireless communication interfaces 112, such as, for example, a near field communication (NFC) interface, enabling... The device 20 may also have a wireless communication interface and / or a cellular communication interface. It may also have one or more of the following: a microphone 106, a touchscreen 104, or a graphical user interface (GUI) screen that generates a screen for a medical event image capture application 114, an optional keyboard or other user input device (not shown), and an audio signal output device (e.g., a speaker or buzzer) 110.

[0062] The medical event image capture application 114 is program code that provides image capture operations for markers and / or drug delivery devices, as well as image processing operations for the captured images. The image processing operations for the captured images may (1) decode or otherwise identify artifacts and related information from markers and other image elements in the captured images, (2) conveniently and automatically record data related to medical events, such as removing needle covers before administration, administering or otherwise moving plungers, drug levels in syringes, and, where applicable, activating needle guards after administration, and (3) perform human-machine interface (HMI) operations or other logical operations that alert the user to selected information and request input or otherwise educate the user about the relevant medical event.

[0063] For example, an image capture operation captures an image from device camera 102. The captured image processing operation can implement two-dimensional (2D) and / or three-dimensional (3D) image processing algorithms to detect selected artifacts from the captured image(s). The captured image processing operation may optionally include recognition operations within application 114, such as a QR code reader, barcode or UPC code reader, or optical character recognition (OCR) operation. The HMI or other operations of the medical event image capture application 114 determine the state of the imaging drug delivery device based on detected artifacts (e.g., variable markings and other aspects of the imaging drug delivery device) and record relevant information in a digital memory device.

[0064] Many patients use low-cost and often disposable delivery devices, such as syringes or auto-injector pens or wearable auto-injectors (e.g., Libertas, available from Becton, Dickinson, and the Company). TM This syringe is used to deliver prescription medications. As shown in Figure 1, a typical syringe 10 is primarily made of plastic or glass and has several components, including a barrel 30, a stopper 32, a plunger 34, and a needle 36. Gradients may be provided on the barrel to allow for accurate drug delivery. Inside the barrel 30, a rubber stopper 32 forms an airtight seal and allows liquid medication or other fluids to be moved in and out of the barrel. The plunger 34 abuts against the rubber stopper 32 to allow it to move back and forth under the user's control. A metal needle 36 or cannula is typically attached to the distal end of the barrel to allow fluid to be injected into or removed from the barrel, but this is not always the case. For example, a syringe with a male Luer connector at its distal end may be attached to a female Luer connector on a catheter or IV line to inject or withdraw fluid without using a needle or catheter. A large number of syringes can be used in hospitals and nursing facilities for relatively short periods and for patient-managed conditions. The needle can be Luer-Lok. TMThe Luer sliding connector 40 can be detachably attached to the barrel, or it can be permanently attached or "fixed" to the barrel during the manufacture of the syringe.

[0065] The syringe 10 can typically be used with one or more components, such as a needle shield 12 or a needle cover 14. An example needle shield 12 is shown in... Figure 3 It is shown in the diagram and is usually removed before injection.

[0066] Figures 2A, 2B, 2C, and 2D illustrate a typical needle shield 14 for a syringe 10, designed to retract into the syringe after drug delivery to cover the syringe needle within a cavity 56 of the needle shield 14. The needle shield 14 includes a body 46 having a cavity dimensionally designed to receive a shield body plunger 54, which in turn has a cavity 56 dimensionally designed to receive a pre-filled syringe 10. The plunger 54 is slidable within the cavity of the body 46. The body 46 has a body inspection window 48 for observing the plunger and syringe therein, a spring 50 at its distal end, and flanges 52a, b at its proximal end to accommodate a user's fingers. The shield body plunger 54 has an opening 58 at its proximal end to receive the distal end of the syringe 10, and an opening 60 at its distal end through which the shrouded syringe needle protrudes. The spring 50 is circumferentially adjacent to the distal end of the shield body plunger 54. The main body plunger 54 of the shield also has tips 62a, b at its proximal end, which form a recess to receive the proximal end of the syringe plunger 34 during deployment.

[0067] Now refer to Figure 3 , 4A Figures 4B, 5, and 6 illustrate example embodiments of an improved syringe 10, needle shield 12, and needle cover 14, each employing a variable tag and thus providing a low-cost solution to the technical problem of making it more convenient for users to record injection event data involving relatively low-cost drug delivery devices and allowing the collection of other relevant data related to the injection event. For example, the variable tag is provided directly on or applied as a tag to syringe 10 and / or related components (such as needle shield 12 or needle cover 14) and is a relatively low-cost solution compared to other methods for collecting injection information (such as providing RFID tags or sensors or processors and communication interfaces for syringes and autoinjectors).

[0068] Figure 3The syringe 10 is an improved syringe according to an example embodiment, which has a variable mark 80 on its barrel 30. The mark 80 is illustrated as a barcode, but may be, for example, a different optical pattern. When the mark 80 is not changed (e.g., before drug delivery), the mark 80 may represent a first state. When the plunger 34 is deployed, the plunger stopper 32 changes the mark 80 because the mark 80 appears to a reader or scanner due to at least a portion of the mark 80 being blurred. This change may be assigned to the mark 80 by the application 114 to represent a different state (e.g., post-delivery state, current dose state, or fluid remaining state). Alternatively, the plunger 34 may be provided with a second mark 82, and its combination with the mark 80, or its addition to the length of the mark 80, or other means of changing the mark 80, may represent a different assigned state. The second mark 82 may be another barcode, for example, or as... Figure 5 Other types of markings 84 are shown on the plunger or stopper. The syringe 10 may optionally be used with an improved needle shield 12, which is provided with a variable marking 86. The marking 86 may be on a label that is torn off when the shield 12 is removed from the syringe 10 to change the marking 86 (e.g., to make it shorter), thus indicating a different state (such as "injection event" instead of the state of a pre-injection event represented by the unchanged marking 86). Detection of a change in marking 86 can lead to the storage of a timestamp corresponding to the "injection event." In other words, the user only needs to take a picture of the shield 12 after it has been removed from the syringe to automatically detect and record when an injection occurred using application 114. Figure 5 The illustration shows a drug delivery device with variable markers, and an image of it captured using a camera 102 on a smartphone 20 with application 114. It should be understood that... Figure 3 , 4A The drug delivery devices shown in 4B and 6 can be similarly read by a smartphone camera 102 or other types of scanners.

[0069] Figure 4A and 4B Figure 5 illustrates an improved syringe 10 according to an exemplary embodiment, the syringe 10 having a needle guard 14 with variable markings. The variable markings may include a first marking 88 on the needle guard body 46 and a second marking 90 on the needle guard plunger 54. The first marking 88... Figure 4AThe state remains unchanged and can represent the pre-injection state, and is altered (e.g., combined and lengthened) when deployed to retract the syringe needle into the needle sheath body 46 and thus represent the post-injection state. Either state can be detected using a rapid scan or image capture to record the time and state via application 114. This provides the user with another convenient example of a method for recording injection events without manually writing or typing the date / time and other information.

[0070] The advantages of variable codes are not limited to syringes and their related components; they can also be applied to autoinjector pens 18 and wearable autoinjectors. For example, many patients use relatively inexpensive, disposable, pre-filled autoinjector pens for single-use administration of medication. For instance, many diabetic patients use autoinjector pens containing, for example, 300 units of insulin, allowing them to inject themselves with more than one dose from pen 18. (Reference) Figure 6A and 6B The auto-injector pen 18 includes a pen body 64 with a cap 65, a dosage dial, and a window 70. For injection, the user removes the cap 65 and attaches a needle 68 to the pen 18. The pen 18 has a chamber 72 with fluid (e.g., pre-filled, or with a fluid cartridge inserted) and printed graduations 74 to allow the user to visually identify the number of units of fluid in the chamber 72. The pen 18 also includes an actuation mechanism 76 for controlled dispensing of fluid from the chamber 72 through the needle 68 according to the dosage dial 70 settings.

[0071] The pen 18 is improved to have a low-cost variable mark to allow users to conveniently and inexpensively record injection events associated with the pen 18. For example, the chamber 72 may be provided with a variable mark 96, such as a barcode or other pattern. When the drive mechanism 76 is fully retracted, the variable mark 96 remains unchanged and is assigned by the application 114 to indicate the pre-injection state. After the pen 18 has been used for injection, the stopper 78 on the drive mechanism 76 obscures at least a portion of the variable mark 96 to change it and indicate a different state. The processor 100 of the application 114 may analyze the variable mark 96 individually, or utilize the physical characteristics of the chamber 72 captured in a camera image (e.g., the position of the stopper in or relative to the scale 74) to determine, for example, the delivered dose and the remaining fluid in the chamber 72, and automatically record this information in a digital memory.

[0072] Furthermore, the needle 68 can be packaged as a needle adapter 66, which includes an outer cap 67 with a peel-off label 69, the peel-off label 69 surrounding the needle 68 with an inner cap 63. (Continue to the previous section) Figure 6A and 6BThe variable mark 92 can also be applied to the pen cap 65 and the body 64 so that it shortens when the cap is removed. Alternatively, the variable mark 94 can be provided to the outer cap 67 and the label 69 so that it shortens when the label 69 is peeled off. In either case, the user can take an image of the altered variable mark 92 or 94 before injection to conveniently record the injection event. Furthermore, the variable mark 92 or 94 can also include barcode data indicating the pen type and needle type, which can also be recorded in digital memory.

[0073] Instruction sets can achieve Figure 8 A subset of the operations shown. For example, steps 120-126 could be the main operations of the instruction to capture images of one or more variable codes or other markers on a drug delivery device, capture another image of one or more variable codes on the drug delivery device at different times, and analyze the captured images to determine their respective operational phases of the drug delivery device based on any changes detected in the variable codes between images, and optionally provide a time and / or date stamp for each determined phase. Other example operations are shown in... Figure 8 The image shows example phases detected for example syringes 10 used alone or with one or both of needle shield 12 and needle cover 14, as well as related example information generated from images of variable markings on one or more of the syringes 10, needle shield 12, and needle cover 14.

[0074] Figure 8 The illustration depicts example operation of a smartphone 20 or other device (e.g., a dedicated scanning device or iPad) operating according to a medical event image capture application 114. It should be understood that the example embodiment may include computer-readable instructions for execution. Figure 8 A subset of the operations shown. For example, steps 120-126 could be the main operations of the instruction to capture an image of a drug delivery device with one or more variable codes or other markers (boxes 120 and 124), analyze the captured image to identify markers and optional related attributes (box 122), and process the markers and optional related attributes to determine specified information or content, such as associating detected changed markers with a specified state of the drug delivery device (box 126). Figure 8 The other example operations 128-148 shown illustrate example stages detected for example syringes 10 used alone or in conjunction with one or both of needle shield 12 and needle cover 14, as well as related example information that can be generated from images of variable markings on one or more of the syringes 10, needle shield 12, and needle cover 14. It should be understood that the instructions can control other operations related to detecting one or more states of the auto-injector pen.

[0075] For example, for block 126, the computer-readable instructions in application 114 can be configured to store information on assigning different drug delivery device states or operations to corresponding items among an unchanged variable marker and one or more variable markers with corresponding degrees of alteration, such as a pre-delivery state assigned to an unchanged variable marker and a post-delivery state assigned to a marker captured in an image and whose pattern is obscured. As another example, application 114 can be configured to assign a first drug delivery device state to an unchanged variable marker and a second drug delivery device state to a modified form of a variable marker, whereby the marker has been lengthened (in combination with other markers), truncated, or its color or transparency has been changed. Application 114 can also be configured to process captured images of the syringe barrel or window in an auto-injector pen or wearable auto-injector and adjacent variable markers, and determine the remaining fluid volume, or the dose or amount currently dispensed or drawn from the syringe, or the dose delivered.

[0076] Continue to refer to Figure 8 In example operations 128-148, a user operates the camera 102 of a smartphone, or other device with a camera and application 114, to capture an image of the drug delivery device with variable markers at a selected point or stage of an injection event, such as after removal of the pen cap or needle cap, or just before delivery, or just after plunger displacement, or after safety feature deployment (box 120). The captured image processing operation of application 114 analyzes the markers and optional other attributes of the drug delivery device (boxes 122 and 124). Application 114 is configured to control processor 100 to determine the status of the drug delivery device and optionally other relevant device information (box 126). For example, processor 100 of application 114 can determine whether the syringe needle shield 12, indicating the start of an injection event, has been removed (box 128), and based on, as in combination with... Figure 3 The markings on the shielding device described change or alter as the shielding device is removed to record its corresponding timestamp (box 130 and...). Figure 9A Similarly, processor 100 can determine whether the syringe plunger or auto-injector drive mechanism has been moved (block 132) and therefore based on, in combination with Figure 3 , 4A The markings on the syringe barrel or autoinjector window described in 4B, 5, 6A and 6B are altered or blurred due to the plunger stopper or autoinjector drive mechanism to record the corresponding timestamps (box 134).

[0077] Continue to refer to Figure 8 The processor 100 is controlled by the medical event image capture application 114 to determine whether the correct dose has been drawn or delivered, and if not, optionally generates an alert or GUI screen (boxes 136 and 138) for the user. Figure 9B If a needle shield is used, the processor 100 can use first and second markers to detect whether the safety feature has been correctly deployed after injection, for example, in combination with... Figure 4A and 4B As described, and optionally, alerts or GUI screens can be generated to advise the user on any problems or malfunctions (boxes 140 and 142 and...). Figure 9D According to box 144 and Figure 9C The delivered dose may optionally be confirmed as delivered (e.g., via a GUI screen generated on touchscreen 104 by application 114). Medical event data or information (e.g., confirmed dose, detected malfunction, drug delivery operation status, and one or more other data obtained via image capture processing operations of application 114) may be stored locally or remotely for access and use by patients and / or other medical condition management stakeholders (box 146). For example, medical event data or information may be automatically uploaded to a repository for inclusion in the patient's electronic record for medical billing, automatic replenishment of medical supplies and / or sequential tracking of care plans, and other uses such as incorporation into a comprehensive disease management system (box 148).

[0078] The illustrative embodiments disclose various ways to better interact with users and leverage the advantages of both the drug delivery device and the medical event image capture application 114 to enhance the user experience. Application 114 is used to identify specific features and activities, confirm whether they are as expected, provide confirmation to the user, and also enables the recording and tracking of information for future generations. In summary, the combined use of the drug delivery device with variable labeling and application 114 can drive better adherence and improved patient outcomes. For example, the illustrative embodiments described herein facilitate the recording of injection events and related information, such as the delivered dose, which in turn provides more accurate data for better clinical decision-making. While primarily aimed at the self-injection patient population, the combination of application 114 with the drug delivery device with variable labeling can be used in other settings (e.g., institutions and backup sites) and by caregivers (e.g., nurses, family members, etc.).

[0079] It should be understood that, when used in this specification, the terms "include", "including", "comprise" and / or "comprising" specify the presence of the stated feature, integer, step, operation, element and / or component, but do not exclude the presence or addition of one or more other features, integers, steps, operations, elements, components and / or groups thereof.

[0080] It will be further understood that while the terms “first,” “second,” “third,” etc., may be used herein to describe various elements, components, regions, layers, and / or portions, these elements, components, regions, layers, and / or portions may not be limited by these terms. These terms are used only to distinguish one element, component, region, layer, or portion from another element, component, region, layer, or portion.

[0081] 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," when preceding a list of components, modify the entire list of components and not the individual components within it. Furthermore, terms such as "unit," "component," and "module" as described in the specification refer to an element for performing at least one function or operation, and can be implemented in hardware, software, or a combination of hardware and software.

[0082] Various terms are used to refer to specific system components. Different companies may use different names to refer to components—this document does not intend to distinguish between components with different names but the same function.

[0083] The aspects of these exemplary embodiments that are obvious to those skilled in the art to which these exemplary embodiments pertain may not be described in detail herein.

[0084] The components of the illustrative devices, systems, and methods employed according to the embodiments described herein can be implemented at least in part in digital electronic circuit systems, analog electronic circuit systems, or computer hardware, firmware, software, or combinations thereof. For example, these components can be implemented, for instance, as computer program products, such as computer programs, program code, or computer instructions tangibly implemented in an information carrier or machine-readable storage device for execution or control of operation by a data processing apparatus such as a programmable processor, computer, or multiple computers.

[0085] Computer programs can be written in any programming language, including compiled or interpreted languages, and can be deployed in any form, including as standalone programs or as modules, components, subroutines, or other units suitable for use in a computing environment. Computer programs can be deployed to execute on a computer or other device, or on multiple devices at a single site, or distributed across multiple sites and interconnected via a communication network. Furthermore, programmers in the art can readily develop functional programs, code, and code segments to implement the features described herein. The method steps associated with the example embodiments can be executed by one or more programmable processors that execute computer programs, code, or instructions to perform functions (e.g., by manipulating input data and / or generating output). The method steps can also be executed by a dedicated logic circuit system, such as a field-programmable gate array (FPGA) or an application-specific integrated circuit (ASIC), and the apparatus described herein can be implemented as a dedicated logic circuit system, such as an FPGA or an ASIC.

[0086] The various illustrative logic blocks, modules, and circuits described in conjunction with the embodiments described herein can be implemented or executed using a general-purpose processor, a digital signal processor (DSP), an ASIC, an FPGA, or other programmable logic devices designed to perform the functions described herein, discrete gate or transistor logic, discrete hardware components, or any combination thereof. A general-purpose processor may be a microprocessor, but alternatively, the processor may be any conventional processor, controller, microcontroller, or state machine. The processor may also be implemented as a combination of computing devices, such as a combination of a DSP and a microprocessor, multiple microprocessors, one or more microprocessors integrated with a DSP core, or any other such configuration.

[0087] As an example, processors suitable for executing computer programs include general-purpose and special-purpose microprocessors, as well as any one or more processors in any type of digital computer. Typically, a processor receives instructions and data from read-only memory or random access memory, or both. The basic components 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 one or more mass storage devices for storing data, or operatively coupled to receive data from or transfer data to such mass storage devices, such as magnetic disks, magneto-optical disks, or optical disks. Information carriers suitable for implementing computer program instructions and data include all forms of non-volatile memory, including, as examples, semiconductor memory devices such as electrically programmable read-only memory (EPROM), electrically erasable programmable ROM (EEPROM), flash memory devices, and data storage disks (e.g., magnetic disks, internal hard disks or removable disks, magneto-optical disks, and CD-ROM and DVD-ROM disks). The processor and memory may be complemented or integrated into a dedicated logic circuit system.

[0088] Computer-readable non-transitory media includes all types of computer-readable media, including magnetic storage media, optical storage media, flash memory media, and solid-state storage media. It should be understood that software can be installed in and sold with a central processing unit (CPU) device. Alternatively, software can be obtained and loaded into a CPU device, including through physical media or distribution systems, such as from a server owned by the software creator or from a server not owned by the software creator but used by the software creator. For example, software can be stored on a server for distribution via, for example, the Internet.

[0089] It is understood that the exemplary embodiments described herein should be considered descriptive only and not for limiting purposes. The description of features or aspects within each exemplary embodiment can be considered applicable to other similar features or aspects in other exemplary embodiments. Although exemplary embodiments have been described with reference to the figures, those skilled in the art will understand that various changes in form and detail may be made therein without departing from the spirit and scope defined by the following claims.

Claims

1. A medical delivery system, comprising: A drug delivery device, selected from syringes, auto-injector pens, and wearable auto-injectors, the drug delivery device including a variable marker that is changed after a specified operation of the drug delivery device selected from removing a pen cap or needle cap, moving a plunger or other drive mechanism to dispense fluid from the drug delivery device, mechanical movement of components of the drug delivery device, and movement of drug delivery device components after fluid dispensing. as well as A set of computer-readable instructions analyzes an image of the variable marker and assigns a first state to the drug delivery device when the image analysis detects that the variable marker has not changed, and assigns a second state to the drug delivery device when the image analysis detects that the variable marker has changed due to a specified operation of the drug delivery device, and stores the assigned state in a memory device. The syringe includes 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, a variable mark being provided on the needle shield and configured to change by removing the needle shield from the syringe, a first state of the syringe in which the needle shield is attached to the syringe and a second state of the syringe in which the needle shield is removed from the syringe.

2. The medical delivery system of claim 1, wherein the set of computer-readable instructions is configured to deliver the determined needle shield to another device in a first state of securing the needle shield to the syringe or in a second state of removing the determined needle shield from the syringe.

3. The medical delivery system of claim 1, wherein the variable mark is provided on the syringe as a printed label fixed to the syringe and is operable to tear off a portion of the printed label from the syringe when the needle shield is removed from the syringe, thereby changing the variable mark.

4. The medical delivery system of claim 1, wherein when the needle shield is attached to the syringe, the needle obscures at least a portion of the variable mark to indicate a first state of the syringe, and when the needle shield is removed from the syringe, the variable mark is not obscured by the needle to indicate a second state of the syringe.

5. A medical delivery system, comprising: A drug delivery device, selected from syringes, auto-injector pens, and wearable auto-injectors, the drug delivery device including a variable marker that is changed after a specified operation of the drug delivery device selected from removing a pen cap or needle cap, moving a plunger or other drive mechanism to dispense fluid from the drug delivery device, mechanical movement of components of the drug delivery device, and movement of drug delivery device components after fluid dispensing. as well as A set of computer-readable instructions analyzes an image of the variable marker and assigns a first state to the drug delivery device when the image analysis detects that the variable marker has not changed, and assigns a second state to the drug delivery device when the image analysis detects that the variable marker has changed due to a specified operation of the drug delivery device, and stores the assigned state in a memory device. The drug delivery device is a syringe, and the variable mark includes at least a first mark on the syringe. The syringe includes a barrel having a cavity for holding fluid, an opening at its proximal end for receiving a plunger, an opening at its distal end for fluid connection with a needle, and a plunger movable within the cavity of the barrel and including a stopper at its distal end. A set of computer-readable instructions analyzes an image of the first mark and assigns a first state to the syringe when the image analysis detects that the first mark has not changed, and assigns a second state to the syringe when the image analysis detects that the first mark has changed due to movement of the plunger. The medical delivery system also includes a needle shield, which comprises: A needle guard plunger having a plunger cavity that at least partially receives the syringe, and A body having a body cavity that at least partially receives a needle shroud plunger. The needle guard plunger has an opening at its proximal end to receive the syringe into the plunger cavity, and an opening at its distal end through which the syringe needle extends in the pre-delivery state. The body has a spring mechanism at its distal end, which engages the distal end of the needle guard plunger in an energy-storing state during the pre-delivery state, and is operable in an energy-released state to push the needle guard plunger and the syringe towards the proximal end of the body to retract the needle of the syringe back into the body after the syringe has completed the delivery of fluid therefrom. The first mark on the syringe remains unchanged during the pre-delivery state and is changed after the spring mechanism pushes the needle guard plunger and the syringe to retract the needle back into the body.

6. The medical delivery system of claim 5, wherein the main body includes a window through which the first mark on the syringe can be seen.

7. The medical delivery system of claim 5, wherein the variable mark is capable of including a second mark, and the plunger of the syringe is provided with at least one of a stopper and the plunger or the second mark on the stopper, and image analysis detects that when a condition occurs selected from the first mark being at least partially obscured by the stopper, the first mark being at least partially obscured by the second mark, and the first mark and the second mark being combined in an image, the first mark is changed by movement of the plunger to indicate a second state of the syringe.

8. The medical delivery system of claim 7, wherein image analysis employs a combination of the first marker and the second marker to detect that the spring mechanism has advanced the needle shield plunger and the syringe to retract the needle back into the body.

9. The medical delivery system of claim 5, wherein the variable marker is capable of including a second marker, and the plunger of the syringe is provided with the second marker, and image analysis employs a combination of the first marker and the second marker to detect that the spring mechanism has advanced the needle guard plunger and the syringe to retract the needle back into the body.

10. The medical delivery system of claim 9, wherein image analysis includes determining whether the combination of the first marker and the second marker includes a modified marker whose length is increased compared to either the first marker or the second marker.

11. The medical delivery system of claim 5, wherein the set of computer-readable instructions is configured to deliver either a determined first state corresponding to the syringe not changing during the pre-delivery state or a determined second state corresponding to advancing the needle shroud plunger and the syringe to retract the needle into the body to another device.

12. A medical delivery system, comprising: A drug delivery device, selected from syringes, auto-injector pens, and wearable auto-injectors, the drug delivery device including a variable marker that is changed after a specified operation of the drug delivery device selected from removing a pen cap or needle cap, moving a plunger or other drive mechanism to dispense fluid from the drug delivery device, mechanical movement of components of the drug delivery device, and movement of drug delivery device components after fluid dispensing. as well as A set of computer-readable instructions analyzes an image of the variable marker and assigns a first state to the drug delivery device when the image analysis detects that the variable marker has not changed, and assigns a second state to the drug delivery device when the image analysis detects that the variable marker has changed due to a specified operation of the drug delivery device, and stores the assigned state in a memory device. The medical delivery system also includes a needle shield, which comprises: A needle shield plunger having a plunger cavity that at least partially receives the syringe, and A body having a body cavity that at least partially receives the needle shroud plunger. The needle guard plunger has an opening at its proximal end for receiving the syringe into the plunger cavity, and an opening at its distal end through which the syringe needle extends when in the pre-delivery state. The body has a spring mechanism at its distal end, which engages the distal end of the needle guard plunger in an energy-storing state during the pre-delivery state, and is operable in an energy-released state to push the needle guard plunger and the syringe towards the proximal end of the body to retract the needle of the syringe back into the body after the syringe has completed the delivery of fluid therefrom. The variable markings include a first marking on the body and a second marking on the needle shroud plunger. The variable markings are assigned to the first state by the set of computer-readable instructions during the pre-delivery state and are assigned to the second state after the spring mechanism pushes the needle shroud plunger and the syringe to retract the needle into the body.

13. A medical delivery system, comprising: A drug delivery device, selected from syringes, auto-injector pens, and wearable auto-injectors, the drug delivery device including a variable marker that is changed after a specified operation of the drug delivery device selected from removing a pen cap or needle cap, moving a plunger or other drive mechanism to dispense fluid from the drug delivery device, mechanical movement of components of the drug delivery device, and movement of drug delivery device components after fluid dispensing. as well as A set of computer-readable instructions analyzes an image of the variable marker and assigns a first state to the drug delivery device when the image analysis detects that the variable marker has not changed, and assigns a second state to the drug delivery device when the image analysis detects that the variable marker has changed due to a specified operation of the drug delivery device, and stores the assigned state in a memory device. The drug delivery device is an auto-injector pen, and the variable mark is provided on at least one of the following: a pen cap removably attached to the auto-injector pen; a needle removably attached to the auto-injector pen; a dose window visible through which the fluid is delivered and a drive mechanism configured to expel fluid from the auto-injector pen; and a fluid cartridge if the auto-injector pen is reusable. The variable mark is located on or adjacent to the dose window or the body of the auto-injector pen, and the drive mechanism has a rubber seal at its distal end that is translated to dispense fluid. A set of computer-readable instructions analyzes one or more images of the variable mark and, when analysis of the one or more images detects that the variable mark has not changed, assigns a first state to the drug delivery device. A second state is assigned to the drug delivery device when analysis of the one or more images detects a condition selected from at least partially obscuring the variable mark by the rubber seal, a change in the position of the portion of the variable mark obscured by the rubber seal, and a change in the variable mark relative to a measurement scale located on or adjacent to the dose window due to at least one of fluid dispensing or movement of the rubber seal. The set of computer-readable instructions is configured to process the captured images of the dose window and determine the dose dispensed or delivered.

Images