Color code authentication of medicine cartridges using a single-pixel color imaging sensor

Abstract

To provide a low-cost method for drug authentication. [Solution] Cartridges that store therapeutic agents can be authenticated before the therapeutic agent is applied to a user using an inexpensive process involving cloud storage and color detection. An applicator for delivering the therapeutic agent can include a space for receiving a cartridge that can be selected from a group of cartridges, a color sensor configured to detect the color of a color-coded identification mark on the selected cartridge, and a processor that can receive profile information from a cloud service, including color information about what the color-coded identification mark should be, and match the color of the color-coded identification mark on the cartridge with the color information. The processor can control whether the applicator enables delivery of the therapeutic agent based on the authentication. The profile information can be uploaded by scanning a QR code on the cartridge and uploading associated data to the cloud service.

Description

[Technical Field]

[0001] (CROSS-REFERENCE TO RELATED APPLICATIONS) This application claims the benefit of U.S. Provisional Patent Application No. 63 / 400,802, entitled "COLOR CODE AUTHENTICATION OF A DRUG CARTRIDGE USING SINGLE-PIXEL COLOR IMAGING SENSOR," filed August 25, 2022, the entirety of which is incorporated by reference for all purposes.

[0002] FIELD OF THE INVENTION The present disclosure relates generally to medication cartridge authentication, and more particularly to using a single pixel color imaging sensor to detect a color code on a medication cartridge to authenticate the medication cartridge before the medication can be applied to a patient via an applicator. [Background technology]

[0003] Many patients suffering from eye and / or respiratory diseases may need to take one or more medications throughout the day using an applicator or similar-looking applicators (e.g., inhalers, eye drop sprayers, etc.). For example, patients with chronic obstructive pulmonary disease (COPD) often take two or more inhaler medications per day, and patients with vision-loss glaucoma often take two or more different eye medications per day. Such patients may become confused about which medication(s) they need to take at a particular time, as well as which medications they have already taken, especially when using only a single applicator for multiple medications. A method is needed to track which medications have been properly administered by a patient via the same applicator within a given period (e.g., prescription time, week, day, morning / night, etc.). It is also important to ensure that a given patient is not using the wrong medication or a counterfeit version of a medication (e.g., which may not contain the appropriate compound) and to stop users from applying the wrong medication or counterfeit medication. Patients also have the habit of using older or expired (e.g., less effective) medications or not renewing prescriptions when cartridge volumes are low, thus creating a need to track cartridge age and alert the patient or their caregiver when a cartridge is expired and / or low in volume. Cost is often a major obstacle to monitoring patient compliance, therefore, a low-cost method to solve all of these problems (such as tracking application timing, verifying medication authenticity, quantity, and expiration date) is needed. Summary of the Invention

[0004] The present disclosure describes a low-cost authentication method for authenticating a medication cartridge delivering a therapeutic agent for application to a patient. The authentication method utilizes a single-pixel color imaging sensor to detect the color marked on the medication cartridge in a color-coded identification mark and authenticates the medication cartridge based on the color and information associated with the medication cartridge in a cloud service, such as a cloud-stored database. An entry in the cloud-stored database may be created based on a barcode (e.g., a QR code) printed on the medication cartridge or information stored in the associated cartridge product packaging. Thus, the cartridge may be authenticated before the therapeutic agent in the cartridge can be applied via an applicator. The database may also include or be updated with various information regarding the cartridge and therapeutic agent applied to a given user, such that a given user's history with the therapeutic agent can be tracked.

[0005] In one aspect, the present disclosure includes a system for applying an authenticated therapeutic agent to a user, the system including at least one cartridge holding the therapeutic agent and an applicator for delivering the therapeutic agent in the cartridge. Multiple cartridges can be used with a single applicator. Each cartridge can be distinguished from others by a unique color-coded identification mark on the outside of the cartridge and is configured to hold the therapeutic agent. The color-coded identification mark is unique to the therapeutic agent. Furthermore, the color code is associated with barcode (QR code) information previously established in the cloud, so that the user does not need to rescan and reverify the printed barcode with each use. A cartridge registration event occurs only once upon the first original use of a new cartridge, and thereafter, cartridge use is detected and verified based on automatic detection in the applicator of the cartridge's color code. The applicator is configured to deliver the therapeutic agent from the cartridge to the user. The applicator includes a cartridge-receiving space configured to hold a single cartridge selected from a group of cartridges used by the patient. The applicator also includes a color sensor configured to detect the color of the color-coded identification mark on the cartridge when the cartridge is in the cartridge-receiving space. The applicator further includes at least one processor in communication with the cloud service, the processor being configured to receive a color of the color-coded identification mark on the cartridge from the color sensor, receive profile information from the cloud service, the profile information including stored information associated with the at least one cartridge, the stored information including at least color information of the color-coded identification mark of the at least one cartridge, match the color of the color-coded identification mark with the color information, and if the colors match, enable the applicator to apply the therapeutic agent, and if the colors do not match, stop the applicator from applying the therapeutic agent.

[0006] In another aspect, the present disclosure includes an applicator device configured to deliver a therapeutic agent to a user. The applicator includes a cartridge-receiving space configured to hold a cartridge having a color-coded identification mark on an exterior of the cartridge, the cartridge configured to store a therapeutic agent to be delivered by the applicator. The applicator also includes a color sensor configured to detect a color of the color-coded identification mark on the exterior of the cartridge, the color-coded identification mark being unique to the therapeutic agent. The applicator also includes at least one processor in communication with a cloud service, the processor receiving the color of the color-coded identification mark on the cartridge from the color sensor and receiving profile information from the cloud service, the profile information including stored information associated with the cartridge, the stored information including at least color information of the color-coded identification mark of at least one cartridge associated with a user, and matching the color of the color-coded identification mark with the color information, and enabling the applicator to apply the therapeutic agent if the colors match and stopping the applicator from applying the therapeutic agent if the colors do not match.

[0007] In another aspect, the present disclosure includes a method for authenticating a cartridge holding a therapeutic agent. The method includes scanning, via a system including a processor, a barcode (e.g., a QR code) on the exterior of the cartridge storing the therapeutic agent or scanning associated packaging within which the cartridge is purchased. The barcode is associated with data related to at least color information of a color-coded identification marking associated with the therapeutic agent and dosage information associated with the therapeutic agent for a user of the system. Linking, via the system, the data with a user profile on a cloud service. Detecting, via a color sensor of the system, a color of the color-coded identification marking on the cartridge. Receive, by the system, profile information from the cloud service, the profile information including stored information associated with at least one cartridge, the stored information including at least color information of the color-coded identification marking of the at least one cartridge. Matching, by the system, the color of the color-coded identification marking against the color information, and enabling an applicator to apply the therapeutic agent if the colors match and stopping the applicator from applying the therapeutic agent if the colors do not match. After the initial cartridge cloud registration verifies the color code, the applicator also disables application of therapeutic agent from that cartridge if the calculated expiration date is exceeded. [Brief explanation of the drawings]

[0008] The foregoing and other features of the present disclosure will become apparent to those skilled in the art to which the present disclosure pertains from a reading of the following description taken in conjunction with the accompanying drawings. [Figure 1] 1 shows a diagram of a system capable of authenticating at least one medication cartridge containing a therapeutic agent that can be delivered to a patient. [Figure 2] 2 shows a diagram of the system of FIG. 1 authenticating a medication cartridge. [Figure 3]2 shows a diagram of the system of FIG. 1 entering information related to a medication cartridge into a profile database on a cloud service. [Figure 4] 1 shows an example of how the color sensor of FIG. 1 may operate. [Figure 5] FIG. 1 shows a process flow diagram illustrating a method for authenticating a cartridge containing a therapeutic agent. [Figure 6] 1 shows an exemplary bottle with a QR code printed on the packaging and color-coded identification marks printed on the bottle. [Figure 7] An example of how at least a portion of FIG. 1 may be used in practice is shown below. DETAILED DESCRIPTION OF THE INVENTION

[0009] I. Definition Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure pertains.

[0010] As used herein, the singular forms "a," "an," and "the" may also include the plural forms unless the context clearly indicates otherwise.

[0011] It will be further understood that as used herein, the terms "comprises" and / or "comprising" may specify the presence of stated features, steps, operations, elements, and / or components, but do not exclude the presence or addition of one or more other features, steps, operations, elements, components, and / or groups.

[0012] As used herein, the term "and / or" may include any and all combinations of one or more of the associated listed items.

[0013] As used herein, the terms "first," "second," etc., should not limit the elements described by these terms. These terms are used only to distinguish one element from another. Thus, a "first" element discussed below could also be referred to as a "second" element without departing from the teachings of the present disclosure. The order of operations (or acts / steps) is not limited to the order presented in the claims or drawings unless specifically indicated otherwise.

[0014] As used herein, the term "cartridge," also known as a "medication cartridge," refers to a portable, self-contained reservoir for a therapeutic agent. A portion of the drug cartridge may be open or openable for release of the therapeutic agent. The opening may be covered to prevent release of the therapeutic agent. In some cases, the covering can facilitate release of the therapeutic agent from the reservoir when triggered by an applicator device.

[0015] As used herein, the term "therapeutic agent," also known as a "medication" or "drug," refers to one or more substances (e.g., liquids, solids, and / or gases) associated with the treatment, symptomatic relief, and / or palliative care of a disease, injury, or other condition. Examples of therapeutic agents can include one or more pharmaceutical drugs, saline solution, etc.

[0016] As used herein, the term "applicator," also known as an "applicator device," refers to any device capable of applying and / or delivering a therapeutic agent to a patient as a liquid, solid, or gas from a cartridge. Non-limiting examples of applicators include sprayers, eye drop applicators, inhalers, etc.

[0017] As used herein, the terms "user," "subject," and "patient" may be used interchangeably and refer to any warm-blooded organism, including, but not limited to, humans, pigs, rats, mice, dogs, cats, goats, sheep, horses, monkeys, apes, rabbits, cows, etc.

[0018] II. Overview Patients, including those who need to use eye drop applicators, inhalers, etc., may take or be prescribed to take more than one medication over the same time period (often requiring two or more different medications within a single day). It would be advantageous for these patients to be able to use a common device to deliver these different medications. However, patients often struggle to accurately maintain dosage schedules and / or properly order and use up-to-date medications. Medication cartridges often look similar, and when using a single applicator for multiple medications, patients may forget or fail to check which cartridge is in the applicator at a given time. Patients may also use medication less frequently or in smaller doses than prescribed for cost-saving reasons. In addition, patients may be unaware that a cartridge is nearing empty or its expiration date, or may continue to use a cartridge until it is completely empty, regardless of its expiration date, for additional cost-saving reasons. Indeed, cost is often a major obstacle and source of problems for patient compliance. Such errors and problems can be prevented through drug authentication. Therefore, a low-cost method for drug authentication is needed to reduce patient hardship and would be a welcome addition to physician compliance monitoring to ensure accurate use of prescribed therapeutics.

[0019] As described herein, the present disclosure relates to a low-cost method for using a single-pixel color imaging sensor to detect a color code on a medication cartridge and authenticate the medication cartridge before the medication can be applied to a patient via an applicator. Information about the cartridge and the therapeutic agent held therein can be found from a barcode (e.g., a QR code) on the cartridge and stored in a profile database on a cloud service, which can be used to authenticate the cartridge when it is first used and can be linked to the measured color code for all subsequent uses in the applicator. The present disclosure can also relate to tracking various information about the cartridge and the therapeutic agent applied to a given user, such as the time and amount of application, the amount of therapeutic agent remaining in a given cartridge, and the age of the cartridge.

[0020] III.System One aspect of the present disclosure includes a system 10 ( FIG. 1 ) that can authenticate and then apply a therapeutic agent in a cartridge (e.g., one or more cartridge(s) 12; e.g., “cartridge” applies to all uses of the word) using a cloud-based authentication technique and a machine-readable color coding scheme. Each cartridge (1) can be configured to hold a therapeutic agent for delivery to a patient and (2) can have a color-coded identification mark 14 (also referred to as a color code) directly on the cartridge and a barcode (represented throughout by a QR code 16, but understood to be merely an example) on the exterior of the cartridge or even on associated packaging upon purchase (e.g., printed on a label attached to the cartridge). The color-coded identification mark 14 can be unique to the therapeutic agent held in each of the cartridges 12. The color code can identify the therapeutic agent based on a color coding scheme linked to the QR code. Note that the color coding scheme need not conform to an international standard used by people to distinguish between types of ophthalmic therapeutic agents in cartridges, but the color code can also conform to an international standard. The QR code 16 may be unique to a therapeutic agent, or may be unique to a patient and / or a given prescription. The QR code 16 may be associated with data including at least color information for color-coded identification marks associated with the therapeutic agent of at least one cartridge and dosage information associated with the therapeutic agent for the user.

[0021] The system 10 can authenticate the cartridge and / or the therapeutic agent carried by the cartridge before delivering the therapeutic agent to the patient. The system 10 can also track information regarding at least one cartridge and the patient's use of at least one cartridge. Thus, the system 10 can provide a low-cost way to track which medications have been delivered to a patient via the applicator 18 within a given time period (e.g., prescription time, week, day, morning / evening, etc.), verify that a given patient is not using the wrong medication or a counterfeit version of a medication (e.g., that may not contain the proper chemical compound), stop a user from applying the wrong medication or a counterfeit medication, track the age of a cartridge, and alert the patient or the patient's caregiver when a cartridge is expired and / or low in volume, all at no cost. As an example, tracking can use a cloud service 26 populated using the QR code 16 on the cartridge 12 and accessed using the color code 14 on the cartridge. Note that for a given use of the system 10, a single cartridge can be selected and inserted into the applicator 18. The color code 14 can provide a low cost approach with zero cost impact on the cartridges since they are already conventionally labeled.

[0022] The system 10 may include an applicator 18 that can at least one of detect the presence of a cartridge, detect a color code of the cartridge, and communicate with a cloud service 26 to receive information linked to the cartridge and the applicator 18 via the color code (e.g., stored in one or more databases). The applicator 18 may be any device that can be used to deliver a therapeutic agent from a cartridge to at least a portion of a patient's body. For example, the applicator 18 may be an eye drop applicator, an inhaler, or the like. The therapeutic agent may be used to treat an ophthalmic condition, a respiratory condition (e.g., COPD, asthma, etc.), or other conditions / diseases. As an example, the applicator may be used to apply multiple different eye drops to treat multiple eye diseases. Notably, because the applicator 18 does not need to detect a cartridge during installation of the cartridge into the applicator 18, the applicator 18 can remain asleep while different cartridges are installed.

[0023] The applicator 18 can deliver a therapeutic agent from a cartridge to a user. The delivery mechanism of the applicator 18 can depend on the use of the applicator and the type of agent it is intended to dispense and / or deliver (e.g., agent for ocular use, oral use, topical use, etc.). The applicator 18 can include a cartridge-receiving space 24 that can hold a cartridge (e.g., a cartridge selected from the group of cartridges 12). The cartridge-receiving space 24 can be shielded from external light when closed (e.g., during use of the applicator 18 to deliver a therapeutic agent, but not when the cartridge is being inserted or removed). The applicator 18 can also include a color sensor 22 that can detect the color of the color-coded identification marking 14 on the cartridge when the cartridge is placed within the cartridge-receiving space 24. The color sensor 22 can detect the color of the color-coded identification marking 14 with a single pixel, as described further below. The single pixel can detect the number of machine-readable combinations by 2. NIt should be understood that this is merely an example that can be extended to more than two pixels, such that N can be extended by a factor of 1, where N is a positive integer. As an example, color sensor 22 can be a small, low-cost, surface-mount photodetector with multiple color filters, such as the TCS34725 available from AMS OSRAM. In particular, color filters with infrared blocking filters can stabilize color measurements against background temperature changes.

[0024] The applicator 18 may also include at least a processor 20 that communicates (e.g., wirelessly, WIFI, Bluetooth, etc.) with a cloud service 26. In some examples, communication may be direct between the processor 20 and the cloud service 26. In other examples, the processor 20 may communicate with the cloud service 26 indirectly through the use of a paired mobile device 28 that has an appropriate software application loaded on it. The applicator 18 may also include non-transitory memory, a transceiver, a display, or a speaker (not shown). For example, the processor 20 may also be in communication (wired or wireless) with non-transitory memory that stores instructions for the processor to execute. The processor 20 may execute instructions including, but not limited to, receiving data, authenticating the cartridge, and tracking information about the cartridge and / or therapeutic agent.

[0025] As mentioned above, system 10 may also include mobile device 28 that may be in communication with cloud service 26 and / or processor 20 (as indicated by dashed lines, as communication may be either and / or both). Similarly, processor 20 may be in communication with cloud service 26 and / or mobile device 28 (as indicated by dashed lines, as communication may be either and / or both).

[0026] The mobile device can scan the QR code 16 on the cartridge and communicate with the cloud service 26 to associate the cartridge with the applicator 18 and record the correct color code for that cartridge. The mobile device 28 can also upload additional information about the cartridge based on the QR code, such as data associated with the prescription, data associated with the expiration date of the therapeutic drug, etc. The mobile device 28 can be a cell phone, tablet, laptop, etc.

[0027] The mobile device 28 can communicate with at least the cloud service 26. The mobile device 28 can be used to scan the QR code 16 on the cartridge 12 to access data associated with the QR code. The mobile device 28 can upload at least a portion of the data to the cloud service 28 (and, optionally, to the mobile device's internal memory) and link at least a portion of the data to the applicator 18 on the cloud service. The mobile device 28 can be, for example, a smartphone, tablet, handheld scanner, etc. that includes an image sensor, some form of processor and memory (e.g., at least partially embedded in hardware), and a transceiver. The mobile device 28 can be used to create a profile of the user of the applicator 18 that is stored in a database within the cloud service 26 in which data associated with the QR code is stored. The mobile device 28 can be used to scan the QR code 16 on each cartridge a patient has when the patient obtains and / or begins using the cartridge.

[0028] As shown in FIG. 2 , the applicator can identify a cartridge (based on the associated color code) and contact the cloud service 26 for information regarding the identified cartridge. The applicator 18 can also detect the presence or absence of a cartridge in the cartridge-receiving space 24. A selected cartridge 12 can be placed in the cartridge-receiving space 24 of the applicator 18. The applicator 18 can detect the color code (color-coded identification mark 14) of the cartridge 12, thereby initiating authentication. It is assumed that the color code has already been pre-linked to the applicator 18 by scanning the QR code 16 with a mobile device (not shown in FIG. 2 ) and uploading the associated data and the applicator 18 to a database on the cloud service 28. Thus, when the applicator 18 scans the color code of the cartridge 12, at least a portion of the relevant data related to the cartridge 12 can be retrieved from the cloud service 28.

[0029] The applicator 18 can include at least a color sensor 22, which can be shielded from the effects of external light, and a processor 20. The color sensor 22 can detect the color of the color-coded identification marking 14 on the cartridge 12 and transmit the color to the processor 20. For example, the color sensor 22 can identify one or more pixels of the color-coded identification marking 14, providing the color sensor 22 and / or the processor 20 with the ability to distinguish between different types of medications being taken simultaneously by a patient. As an example, the color sensor 22 can have three different hue channels (red, green, and blue (RGB)), and thus the color coding can have three channels with five levels of saturation or grayscale, and thus the printed color can represent 5, which is approximately equal to 7 bits of information. 3The color sensor can provide 125 different values, or levels. Such information has been confirmed through extensive testing. In practice, patients are unlikely to use more than two or three medications at a time, so there is more than enough color-coding information to distinguish between different types. Note that the printed color code can be stable in hue and saturation for extended periods (e.g., six months, one year, two years, three years, etc.) because the coding scheme is fault-tolerant. For example, printed medical-grade labels with a transparent, waterproof coating on top are commonly available and can be utilized for printed color codes, making them scratch-resistant and UV-fade-resistant. Therefore, the printed color code can remain stable for longer than the expiration date of most medications, including drugs. For example, the printed color code can remain stable for several years (e.g., two or three years).

[0030] The processor 20 can receive information / data regarding the color of the color-coded identification markings 14 on the cartridges 12 from the color sensor 22 and can receive profile information from the cloud service 26. The profile information can include stored information associated with at least one cartridge (e.g., obtained from data associated with the QR code(s) 16), such as at least color information for the color-coded identification markings on each of the at least one cartridge. The profile information can also include user-specific information (e.g., bibliographic information, demographic information, health information, prescription information, etc.). The processor 20 can match the color of the color-coded identification markings with the color information from the cloud service 26. If the color matches the color information, the processor 20 can allow the applicator 18 to apply the therapeutic agent from the cartridge 12. If the color does not match the color information, the processor 20 can stop the applicator 18 from applying the therapeutic agent from the cartridge 12. A color mismatch can be due to reasons such as the selected cartridge 12 being counterfeit, the wrong cartridge at a particular time, having already applied the maximum dosage for a period of time, or the cartridge being expired.

[0031] Although not shown in FIG. 2 , after the processor 20 of the applicator 18 verifies and authenticates the cartridge 12 for use, the processor 20 can also track information about the cartridge and its therapeutic agent. For example, the processor 20 can track the use and duration of use of the applicator to apply a therapeutic agent from the cartridge. In another example, the processor 20 can track the volume of therapeutic agent remaining in a given cartridge based on the number of times the cartridge has been used in the applicator. Any portion of this information (up to all of the information) can be transmitted to the user's profile in a database on a cloud server and / or to the user's mobile device. The age of the cartridge can be tracked in the cloud based on the initial registration date of the QR code. The processor can also determine whether the cartridge-receiving space of the applicator is empty based on the color sensor detecting the color of the cartridge-receiving space. The processor 20 can upload this determination to the cloud server and / or generate an alert (audio, visual, or tactile) via the applicator 18 and / or mobile device that the space is empty.

[0032] FIG. 3 shows an example of how a cloud service (or a database on a cloud service) is populated for an applicator (not shown) by subsystem 30, which can be done with each cartridge a patient obtains. The cartridge can have a color-coded identification mark 14 (described with respect to FIG. 2) and a QR code 16 on the outside of the cartridge. A mobile device 28 can be used to scan the QR code 16 (e.g., with a camera or another image sensor). As described above, the QR code 16 can be associated with data including at least color information for the color-coded identification mark associated with the therapeutic agent on the cartridge and dosage information related to the therapeutic agent for the user. This information can be uniquely associated with a single user's applicator. In one example, the information can be associated with the applicator and housed within a HIPAA-compliant platform, ensuring that usage data and compliance are not accessible to external observers (only the user, any parties designated by the user, and one or more medical professionals).

[0033] The mobile device 28 can access data associated with the QR code 16 and upload at least a portion of the data to the user's profile information stored in a database on the cloud service. The mobile device 28 can also save the data in local memory. If the QR code 16 is incorrect (e.g., counterfeit), the data cannot be accessed and the mobile device 28 can notify and / or warn the user and, optionally, third parties (e.g., sellers) associated with and / or affected by the non-counterfeit cartridge. By way of example, the notification may include data that the cartridge is counterfeit, may contain a counterfeit product (which may be harmful or ineffective), or the wrong treatment.

[0034] FIG. 4 shows a more detailed view 40 of an example color sensor 22 of the applicator 18. The color sensor 22 can detect the color code without physically contacting the color-coded identification mark 14. The color sensor 22 can include a light source 42 capable of emitting a constant, uniform light. The light source 42 can be, for example, a white light-emitting diode (LED). Because the warmth and hue of external background lighting can corrupt color code measurements, an internally controlled, bright LED light source is positioned inside the housing to provide stable background illumination. The light source 42 can be positioned to illuminate the color-coded identification mark 14 when the cartridge is within the cartridge-receiving space (not shown in FIG. 4). The light source can be pulsed on and off to allow background color measurements to be subtracted to improve color measurement accuracy. The illumination can be a directional light beam with focused micro-optics. The color sensor 22 also can include a photoreceiver photosensor 44 capable of detecting the color of the illuminated color-coded identification mark 14 of the cartridge. The light receiver 44 may be at least one of a photodiode, a photodetector, a photomultiplier tube, etc., and can detect color from a single pixel. The color sensor 22 can distinguish, for example, at least 125 different color variations. As an example, the color sensor 22 can be easily calibrated and verified during manufacturing by using test cartridges of different hues and saturations. The color sensor 22 can be shielded from light outside the applicator (not shown). As an example, the cartridge can be positioned in the cartridge-receiving space so that the color-coded identification mark 14 faces the back, with the remainder of the cartridge acting as a shield. The light source 42 and light receiver 44 of the color sensor 22 can operate to detect color while external light is blocked by the cartridge. As another example, the outer housing or body of the device can block or shield the area in which the light source 42 and light receiver 44 of the color sensor 22 can operate.

[0035] IV. Method Another aspect of the present disclosure can include a method 50 (FIG. 5) for authenticating a cartridge holding a therapeutic agent using data stored in a cloud service linked to the device applying the cartridge. While method 50 is described as operating on a single pixel, a single pixel can provide a number of machine-readable combinations. N It should be understood that N is merely an example that can be extended to more than one pixel, such as by a factor of N, where N is a positive integer. Method 50 can be performed using system 10 and applicator device 18 described above with respect to Figures 1-4. System 10 of Figure 1 illustrates one example of various components that can be used to perform method 50.

[0036] Method 50 is illustrated as a process flow diagram having a flowchart diagram. For simplicity, method 50 is illustrated and described as being performed sequentially. However, it should be understood and appreciated that the present disclosure is not limited by the illustrated order, as some steps may be performed in a different order and / or simultaneously with other steps illustrated and described herein. Furthermore, not all illustrated aspects are required to implement method 50.

[0037] 5, a method 50 for authenticating a cartridge holding a therapeutic agent for delivery via an applicator (e.g., applicator 18) is shown. Method 50 may include steps 52-54, which include uploading information about a QR code scanned by a mobile device to a cloud service (e.g., one or more associated databases) and associating the code with a particular applicator. Method 50 may also include steps 56-60, which include scanning a color code of the cartridge by the applicator and determining whether the cartridge should be used with the applicator.

[0038] In step 52, a QR code (or other type of barcode) on the exterior of a cartridge storing the therapeutic agent can be scanned (e.g., by a system including at least a processor and an imaging component, such as mobile device 28). The QR code or other type of barcode can be associated with data related to at least color information for a color-coded identification mark associated with the therapeutic agent and dosage information associated with the therapeutic agent for a user of the system. In step 54, the data associated with the QR code or barcode can be linked (or uploaded) to a user profile stored in a database on a cloud service. The data associated with the QR code or barcode can be user profile information. Steps 52 and 54 can occur at any time before the remaining steps of method 50 and can represent the first step in a two-step authentication process. Additionally, the data can be linked to the applicator used to deliver the therapeutic agent to the user.

[0039] In step 56, the color of a color-coded identification mark on a cartridge placed in a system applicator (e.g., applicator 18) can be detected via the system's color sensor (e.g., color sensor 22). As an example, color sensor 22 can be easily calibrated and validated during manufacturing by using test cartridges of different hues and saturations. The detected color can be sent to and received by the system's processor (e.g., processor 20). In step 58, profile information can be received from a cloud service. The profile information can include stored profile information associated with at least one cartridge, where the stored profile information can include at least color information of each color-coded identification mark of at least one cartridge from which the cartridge was selected (e.g., a group of cartridges associated with a user via the first step of the authentication process). In step 60, the color of the color-coded identification mark can be matched to the color information from the stored profile information. The processor can know which color it should match based, for example, on previous instructions, time of day, and / or previous applications of the same or other therapeutic agent within a certain period of time. If the colors match, the applicator may be enabled to apply the therapeutic agent at step 62. If the colors do not match, the applicator may stop applying the therapeutic agent at step 64.

[0040] Other steps not shown may be part of method 50. One such step may include tracking the use of a therapeutic applicator to apply a therapeutic agent from a cartridge, tracking the date and time of use, and tracking the volume of therapeutic agent remaining in the cartridge based on use. By linking a color code to a QR code or barcode and applicator code verified in the cloud upon first use, the age of a cartridge can be tracked for a single user. As another example, by matching the difference in color codes with the difference in the manufacturing expiration date, order date, and / or actual user use date of each of the two cartridges, it can be determined which of two cartridges, each containing the same therapeutic agent, is newer and which is older, ensuring that a user does not accidentally keep an expired cartridge. Color codes may be unique over a period of time (e.g., 5-10 years), and color codes are not reused during the period for which they are unique. In another example, the absence of a cartridge in the applicator can be determined by a color sensor detecting the color of the cartridge-receiving space, which is detectable only if a cartridge is not present in the cartridge-receiving space. A notification (audio, visual, and / or tactile) can be sent to the user that the therapeutic agent cannot be applied because the applicator is empty.

[0041] V. Working Examples 6 and 7 illustrate exemplary real-world embodiments of the systems and devices described herein. FIG. 6 shows an example of a high-resolution QR code printed on packaging (e.g., QR code 16 in FIG. 1 ) and a color code (e.g., color-coded identification mark 14 in FIG. 1 ) printed on a bottle for delivering an ophthalmic therapeutic drug (e.g., cartridge 12 in FIG. 1 ). FIG. 7 illustrates an exemplary implementation of a cartridge with a color identification mark (on the right side of the drawing) and an applicator (on the left side of the drawing). The cartridge and applicator in FIG. 7 can be part of the system 10 in FIG. 1 , where the applicator 18 includes a color sensor 22 in a cartridge-receiving space 24 and a cartridge 12 with a color-coded identification mark 14. The system illustrates how the cartridge 12 can fit into the cartridge-receiving space 24 with the color-coded identification mark 14 facing and at least partially aligned with the color sensor 22.

[0042] From the above description, those skilled in the art will perceive improvements, changes, and modifications. These and other such improvements, changes, and modifications within the skill of those skilled in the art are intended to be covered by the appended claims.

Claims

1. 1. A system comprising: at least one cartridge having an exterior color-coded identification mark, the at least one cartridge configured to hold a therapeutic agent, the color-coded identification mark being unique to the therapeutic agent; an applicator configured to deliver the therapeutic agent from the cartridge to a user; Equipped with The applicator comprises: a cartridge receiving space configured to hold a cartridge, the cartridge being selected from the at least one cartridge; a color sensor configured to detect the color of the color-coded identification mark on the cartridge; a processor in communication with the cloud service; Equipped with The processor: receiving the color of the color-coded identification mark on the cartridge from the color sensor; receiving profile information from the cloud service, the profile information including stored information associated with the at least one cartridge, the stored information including at least color information of the color-coded identification mark of the at least one cartridge; Matching the color of the color-coded identification mark with the color information, If the colors match, allowing the applicator to apply the therapeutic agent; matching the color with the color information, where if the color does not match, the applicator stops applying the therapeutic agent; A system that is configured to:

2. 10. The system of claim 1, wherein the at least one cartridge has a QR code or other barcode printed on the outside of the at least one cartridge or its associated packaging associated with data, the data including at least the color information of the color-coded identification marking associated with the therapeutic agent of the at least one cartridge and dosage information associated with the therapeutic agent for the user.

3. 3. The system of claim 2, further comprising a mobile device in communication with the cloud service, the mobile device configured to scan the QR code or other barcode on the at least one cartridge, access the data associated with the QR code or other barcode, and upload at least a portion of the data to the user's profile information on the cloud service.

4. The processor: tracking the use of the applicator to apply the therapeutic agent from the cartridge and the time of such use; The system of claim 3 , further configured to track the volume of the therapeutic agent remaining in the cartridge based on use of the cartridge in the applicator.

5. 10. The system of claim 1, wherein the processor is further configured to determine which of two cartridges, each having the same therapeutic agent, is newer and which is older by matching the difference in color code with the difference in the manufacturing expiration date, order date, and / or actual user use date of each of the two cartridges.

6. The system of claim 1 , wherein the processor is further configured to determine whether the cartridge-receiving space is empty based on the color sensor detecting a color of the cartridge-receiving space.

7. The color sensor a light source emitting a constant, uniform light and positioned to illuminate the color-coded identification mark when the cartridge is in the cartridge-receiving space; a light receiver configured to detect the color of the illuminated color-coded identification mark.

8. The system of claim 7 , wherein the light source is a white LED.

9. The system of claim 1 , wherein the color sensor is configured to distinguish between at least 125 different color variations.

10. The system of claim 1 , wherein the color sensor is configured to detect color within a single pixel.

11. The system of claim 1 , wherein the cartridge-receiving space is shielded from external illumination.

12. 1. An applicator configured to deliver a therapeutic agent to a user, the applicator comprising: a cartridge receiving space configured to hold a cartridge having a color-coded identification mark on an exterior of the cartridge, the cartridge being configured to store the therapeutic agent to be delivered by the applicator; and a color sensor configured to detect the color of the color-coded identification mark on the exterior of the cartridge, the color-coded identification mark being unique to the therapeutic agent; and a processor in communication with the cloud service; wherein the processor: receiving the color of the color-coded identification mark on the cartridge from the color sensor; receiving profile information from the cloud service, the profile information including stored information associated with the cartridges, the stored information including at least color information of the color-coded identification markings of at least one cartridge associated with the user; Matching the color of the color-coded identification mark with the color information, If the colors match, allowing the applicator to apply the therapeutic agent; matching the color with the color information, where if the color does not match, the applicator stops applying the therapeutic agent; The applicator is configured to:

13. The color sensor a light source emitting a constant, uniform light and positioned to illuminate the color-coded identification mark when the cartridge is in the cartridge-receiving space; and a light receiver configured to detect the color of the illuminated color-coded identification mark.

14. The system of claim 13 , wherein the light source is a white LED.

15. The system of claim 12 , wherein the color sensor is configured to detect color within a single pixel of the color-coded identification mark on the cartridge.

16. The system of claim 12 , wherein the cartridge-receiving space further comprises an external light shield configured to block all external light.

17. 1. A method for authenticating a cartridge containing a therapeutic agent, the method comprising: scanning, via a system including a processor, a QR code or barcode on the exterior of a cartridge storing a therapeutic agent or a package associated with the cartridge being purchased, the QR code or barcode being associated with data relating to at least color information of a color-coded identification mark associated with the therapeutic agent and dosage information associated with the therapeutic agent for a user of the system; linking, via the system, the data with the user's profile on a cloud service; detecting the color of a color-coded identification mark on the cartridge via a color sensor of the system; receiving, by the system, profile information from the cloud service, the profile information including stored information associated with the at least one cartridge, the stored information including at least color information of the color-coded identification mark of the at least one cartridge; and matching the color of the color-coded identification mark with the color information by the system; If the colors match, allowing the applicator to apply the therapeutic agent; matching the color with the color information, where if the color does not match, the applicator stops applying the therapeutic agent; A method comprising:

18. tracking, by the system, use of the treatment applicator to apply the treatment agent from the cartridge and date and time information of said use; 20. The method of claim 17, further comprising tracking, by the system, the volume of the therapeutic agent remaining in the cartridge based on the usage.

19. 18. The method of claim 17, further comprising determining, by the system, which of two cartridges each having the therapeutic agent is newer and which is older by matching the difference in color code with the difference in the manufacturing expiration date, order date, and / or actual user use date of each of the two cartridges.

20. 18. The method of claim 17, further comprising determining the absence of the cartridge based on the color sensor detecting a color of a cartridge receiving space of the system, the color of the cartridge receiving space being detectable only when the cartridge is not present in the cartridge receiving space.

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