Drug delivery device with hidden indicia

Abstract

The invention is useful for various drug delivery devices, including medical syringes, medical pill vials, and medical pill blister packages. The invention utilizes one or more optically readable codes that are initially concealed and then exposed during or after use. Encoded data of the optically readable code may be obtained to provide information for a variety of purposes including, but not limited to, verification of appropriate medication and dose, duration of administration, and successful completion of administration for a given patient.

Description

Technical Field

[0001] The field of the invention is ensuring compliance with an administration regimen in the self-administration of medicaments. Background Art

[0002] Recent advances in biotechnology and medicine have led to a dramatic expansion in the number of biotechnology-derived therapeutics, such as monoclonal antibodies, used to treat a wide range of conditions.

[0003] For a variety of reasons, such drugs must be administered parenterally because, as therapeutic proteins, they would be broken down by the digestive system if administered orally, rendering them ineffective. Therefore, such biopharmaceuticals are typically delivered via administration routes that bypass the digestive system, most typically via intravenous and subcutaneous routes.

[0004] Many diseases treated by such drugs are essentially chronic and need to be treated over a period of months or years. In many cases, patients will keep receiving such treatments for life. Therefore, in order to minimize the burden on patients, it is strongly preferred that such drugs be formulated as liquids for subcutaneous administration. Compared with intravenous injections that must be administered by trained health care professionals in specialist clinics and accompanied by all the logistics and time-consuming considerations that arise therefrom, subcutaneous injection preparations can be provided in a form suitable for patients to self-administer at home. In order to support this trend, combined with the development of subcutaneous drugs themselves, in recent years, there has been a substantial expansion in the development of injection device technology designed to further simplify the injection process, with particular emphasis on self-injection. Such devices include pre-filled syringes, pen-type syringes, automatic injectors, and body-worn injectors. These technologies are typically pre-filled with subcutaneous drug preparations by design, and therefore eliminate the need for patients to transfer liquid drugs from vials, otherwise this is time-consuming, wasteful, and a potential source of medication errors. Most of these devices are essentially single-use, disposable, although there are also reusable devices. These technologies not only benefit patients in terms of convenience and reduced burden of treatment, but also can reduce the cost of treatment by moving treatment to an outpatient setting.

[0005] Although self-administration in a home environment has the aforementioned benefits for patients and healthcare providers, there are still some associated disadvantages and challenges. The most important of these disadvantages and challenges is the risk of medication errors (due to user errors or device failures), and non-compliance with the treatment regimen. Non-compliance may be unintentional or intentional, for example, patients may simply forget to take their medication, or may avoid taking it, for example, to avoid negative side effects. Another problem is that many patients feel anxious at first when injecting themselves. This anxiety may be due to fear of needles, fear of making mistakes, or simply because there is no healthcare professional on the scene to comfort. Although many of these problems also exist for more conventional oral medications (such as tablets and capsules), in the case of biological drug injections, these problems may be exacerbated due to the more invasive route of administration, the lower frequency of the dosing regimen (for example, it may be easier to forget when to complete the dose), and the generally higher cost of the drug (which may increase the anxiety about the cost of making mistakes).

[0006] For these reasons, there has been a significant growth in interest in recent years in providing technical solutions to these problems. These developments have been made possible in large part by recent significant advances in electronics, wireless communications, battery technology, and portable computing, which have driven miniaturization and cost reduction, and it is now feasible to integrate such technologies into injection devices. Using these technologies, it is now possible to give injection devices the auxiliary functionality of a remote networked computer terminal that is guaranteed to be present at the point of care. Typical systems incorporate minimal cost electronics into the injection device itself or an accessory to the injection device, and rely on the data display and wireless communication capabilities of the patient's smartphone to provide a user interface and perform data transfer. For example, a mobile application can be provided that interacts with the injection device via a local or personal area networking technology such as near field communication (NFC), wifi (IEEE802.x), or Bluetooth to create a wireless "binding." With this binding, the device and smartphone application can be synchronized to provide information such as device status, injection progress, or context-dependent instructions to the patient via the smartphone display. The wide-area remote networking capabilities of the smartphone via cellular or wifi technology can then perform remote network access for transmitting data to remote services such as physician portals, electronic health records, etc. Such data may include a record of the injection, including patient identification, medication batch number, device serial number, time and date, geographic location (obtained from the smartphone's GPS location service), and error information. Error information may include, for example, internal error status flags from sensors integrated into the device, such as an injection complete status flag. In this way, a complete local / wide area device communication system may be designed. Implementing the functionality on the user's smartphone has the advantage of minimizing the amount of custom electronic hardware required to implement the system, and also enables the minimal device electronics to be single use, disposable.

[0007] However, despite the great progress made in miniaturization and cost reduction in electronic technology, there are still cost, complexity and sustainability issues associated with the use of electronic devices (especially disposable electronic devices). In response, some injection device manufacturers have chosen to use reusable electronic accessories for single-use disposable prefilled injection devices. Typically, such accessories are combined with minimal electronic devices and mechanically connected to the prefilled injection device. With the help of sensors of known types to those of ordinary skill in the art, such accessories can determine the state of the prefilled injection device and communicate via a wireless communication protocol in the aforementioned manner. Examples of such devices can be found in U.S. Published Patent Application No. 2014 / 0194826A1, U.S. Published Patent Application No. 2019 / 0217022A1, and U.S. Patent No. 10,792,441B2.

[0008] While such reusable electronic accessories circumvent the aforementioned cost and sustainability issues, they do have their own disadvantages, including the addition of more user steps (such as physical connection to the injection device), and additional complexity in the product supply chain, as there may now be two parallel supply chains for the pre-filled injection device and the electronic accessory. The supply chain for the pre-filled injection device typically requires cold chain logistics to maintain the drug at the appropriate storage temperature, typically in the range of 2°C-8°C. On the other hand, electronic accessories do not require cold chain logistics and because they are reusable, there is no one-to-one correspondence with the pre-filled injection device that will support the injection device and the accessory packaged together. In addition, for sustainability reasons, some regions may desire or be forced by regulation to establish a reverse logistics supply chain to recycle or reuse post-market electronic waste. These considerations create complexity and costs that must be borne by actors in the healthcare system.

[0009] Despite the potential benefits of improving medication compliance, the availability of smartphones previously limited the creation and adoption of such systems, but this is no longer an issue in developed countries due to the widespread availability of smartphone technology, and this trend is likely to continue. However, several cost and sustainability issues have hampered the adoption of these technologies.

[0010] A lower cost alternative to the above-described system types has also been proposed based on machine-readable tags. Such systems rely on the ability of a smartphone to read optical or radio frequency tags, such as bar codes, quick response (QR) codes, NFC or RFID tags. Typically, optical or radio frequency tags are applied to the injection device or outer packaging at the time of manufacture. The tag encodes product identifier information, such as identification, strength, batch number, expiration date, and possibly a unique serialization code. When ready for use by a patient, a dedicated smartphone application (each instance of which is uniquely associated with an individual patient) is used to read the information stored on the tag with the help of the smartphone's built-in camera (for optical tags) or radio transceiver (for radio frequency tags). The combination of the tag data from the injection device and the patient's smartphone application's unique identifier, as well as the system date and time and possibly the geographic location, can be used to generate a data packet that provides a time stamp of the date, time and location at which a particular user scanned a particular injection device. With the help of the wide area networking capabilities of the smartphone, this data packet can be transmitted to a remote database, where the data packet can be used for purposes such as compliance monitoring, feedback, safety monitoring, etc. For example, a physician can access the database with the help of a web application to check on the patients under his care. Other features of the smartphone app may include the ability for patients to record symptoms or upload comments and feedback for physicians.

[0011] A limitation of this simple system is that the reading of the tag and the actual use of the device are asynchronous, meaning that there is no guarantee that the tag reading and use will occur at the same time. In fact, a tag reading alone does not confirm that the device has been used at all, only that the tag has been read. This clearly limits the applicability of this technology for compliance monitoring purposes.

[0012] US Patent No. 10,980,948 provides a medical injector having a display that is blank in an initial pre-use state and on which a bar code is generated and displayed after use. The bar code is scannable to provide an indication that the injection has been completed. Summary of the invention

[0013] The present invention improves the known simple monitoring technology by using at least a first optically readable code and a second optically readable code on a drug delivery device, which can be in the form of a medical syringe (e.g., a pen-type syringe, a syringe, a body-wearable syringe), a medical pill bottle, a medical inhaler, and a medical pill blister package. The first optically readable code can be applied to the external part of the drug delivery device as known in the art. The second optically readable code is concealed before using or obtaining a certain dose of medicine, and is revealed during or after use. This makes it possible to distinguish between the "before use" state and the "after use" state. In one method, the present invention utilizes the mechanical characteristics of the medical injection device by placing the second optically readable code on a component, which forms a part of the injection mechanism and shifts from a concealed state to a revealed state during the injection process. Most single-use pre-filled type injection devices have a viewing port or window so that the drug solution can be visually inspected before injection. In many devices known to those of ordinary skill in the art, as the injection proceeds, the window is gradually covered by the traveling component of the injection mechanism. In many devices, this function is used to provide an injection process and / or status indicator. For example, obscuring a window with an opaque component can be used to provide an easy visual check that the device has been used to avoid mistaking a used device for an unused device.

[0014] In another approach, the present invention utilizes the characteristics of a drug container in the form of a pill bottle or blister pack, wherein a portion of the drug container needs to be adjusted or removed to expose the second optically readable code. Although the revelation of the second code requires user intervention, advantageously, normal user interaction with the drug container will cause the revelation.

[0015] These and other features of the present invention will be better understood through a study of the following description and accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] Figure 1-Figure 9 A medical injector according to the invention as a pen injector is shown;

[0017] Figure 10-11 A medical syringe as a syringe barrel according to the present invention is shown;

[0018] Figure 12-Figure 29 A medical syringe as a body-wearable syringe according to the present invention is shown;

[0019] Figure 30-Figure 33 A medical pill bottle according to the present invention is shown;

[0020] Figure 34-Figure 37 shows a medical pill blister package according to the present invention; and,

[0021] Fig.38 A system that may be used with the present invention is shown. DETAILED DESCRIPTION

[0022] The present invention is used for various drug delivery devices, including medical syringes, medical pill bottles, and medical pill blister packages. The present invention utilizes one or more optically readable codes that are initially concealed and subsequently revealed during or after use. The encoded data of the optically readable code can be obtained to provide information for various purposes, including but not limited to verification of the appropriate medication and dosage for a given patient, duration of administration, and successful completion of administration.

[0023] In one embodiment, the first optically readable indicia is applied to the body of the drug delivery device, for example, as part of a product label. The data encoded on the first indicia may include a product identifier (e.g., one or more drugs), the strength of the drug, a manufacturing batch number, a manufacturing time and / or date (the date the drug was manufactured; the time and / or date the drug delivery device was assembled), an expiration date of the drug, and a unique serialization number.

[0024] The second optically readable mark is applied to the drug delivery device so that before use, the second mark is hidden from the field of vision. Use optically readable code to ensure that the second code can be read only when it is within the field of vision. The second mark is only visible after the drug is administered, for example, after injection, wherein the travel part (for example, plunger) has completed its travel to expose the second mark. Optionally, the data encoded on the second mark can include a unique number that is algorithmically related to the unique number encoded in the first mark. The second mark can be used alone without any other optically readable mark.

[0025] As used herein, "optically readable code" (also referred to as "optically readable marking" or "marking") and its derivatives refer to data in a structured format that can be optically read by a computer and processed without human intervention, such as in the form of a barcode, quick response (QR) code, data matrix, etc. In addition, this definition refers to printed machine-readable numeric or alphanumeric characters, which may be particularly useful in situations where the area available for encoding a code (e.g., a QR code) may be too small to be reliably marked and read. In this case, the unique printed number or string can be marked directly on the drug delivery device in a machine-readable font that can also be read by a user (i.e., the printed number or string includes the actual number). Such fonts are known to those of ordinary skill in the art and are widely used in financial documents such as checks and credit cards. Examples are OCR-A, OCR-B, MICR E13B. The advantage of providing the first marking and / or the second marking in printed numeric or alphanumeric form is that it is readable by both humans and machines. This makes it possible to manually enter the code into the application software as a fallback option for situations where the machine vision capabilities of the user device are unable to read the code (e.g., due to insufficient lighting, limited camera resolution, distortion due to refractive surfaces, or loss of partial integrity of the marking making machine vision impossible, etc.).

[0026] Further, as used herein, "drug" refers to one or more therapeutic agents, including a combination or mixture with other components such as diluents, carriers, etc.

[0027] The first optically readable code and the second optically readable code can be applied using any technique, including but not limited to: directly printing (e.g., using inkjet printing, laser printing) on ​​a portion of the drug delivery device (preferably with a sufficiently contrasting color to allow it to be optically read); forming or etching on a portion of the drug delivery device (possibly subsequently colored or painted to provide sufficient contrast for optical reading); and / or printing on a label applied to the drug delivery device, such as by adhering a label with a pressure sensitive adhesive.

[0028] In another aspect of the present invention, a dedicated application software is provided that can be downloaded for use on a camera-equipped, internet-enabled device, which may be referred to herein as a "user device", such as a smart phone, tablet computer, laptop computer, etc. The application software is programmed to capture an image of a drug delivery device using a camera of the user device. Optionally, the application software can be configured to generate a user interface on the user device, which can provide an on-screen guide to guide the user to capture an image with an appropriate field of view. In an embodiment, the application software may include a machine vision algorithm (e.g., an algorithm for one or more of pattern matching, template matching, feature matching) for identifying certain features of the drug delivery device, such as to ensure that the device state is correct for a particular step, and to provide protection to prevent malicious attempts to forge captured images. For example, the application software can be designed to measure the relative distance between the second mark and the first mark or some other appropriate reference point on the drug delivery device, so as to provide additional confirmation of correct use and basic forms of error detection. In the case where the drug delivery device is a medical syringe, this can be used to detect when the travel portion has not yet completed its entire stroke, which may indicate a device failure caused by, for example, a mechanism failure or a needle obstruction. Features or one or more markers on the drug delivery device may be provided to provide distance calibration to compensate for the variable distance of the user device from the drug delivery device. To prevent malicious actors from attempting to "trick" the application software into registering false confirmations of use, for example, by placing fake markers posing as real markers in an attempt to discover secret algorithmic relationships, measurements of relative distances may be used to confirm correct registration of the markers as a basic form of "anti-spoofing" measure. In an alternative embodiment, position markers may be provided directly to the drug delivery device (e.g., on a traveling component).

[0029] Each instance of the application software can be uniquely registered to an individual user via a digital code or user "certificate" or "key" registered with a service provider, so that the collected drug administration data can be parsed at an individual patient level if desired. This can provide a user identification that can be used to associate with the collected data, which is transmitted for review and analysis. The user identification can be assigned to the user (through various channels, for example, by mail, email, hand delivery), generated by the user device when the application software is downloaded, and / or generated by the application software after downloading. The user identification can involve an identification associated with the user device (for example, using a unique International Mobile Equipment Identity (IMEI) associated with the user device. Means for establishing trust with the help of digital certificates and public key encryption are well known to those of ordinary skill in the art and can be implemented in the application software to confirm identification, sign data transmissions, etc.

[0030] As an example, a user removes a drug delivery device in the form of a medical syringe from its packaging and launches and logs into an application software downloaded to a user device. The user is prompted to capture an image of an unused injection device from which optically readable data stored in the optical encoding of a first optically readable mark can be extracted for processing by a machine vision algorithm. The image and extracted data can be stored with a timestamp provided by an operating system of the user device or a remote time server, recording the time and date of image capture. Prior to using the injection device, the application software can also be programmed to confirm, with the aid of a machine vision algorithm, that a second mark is not present to confirm that the device has not been used. The patient is then prompted to proceed with his injection as usual. After the injection, the application software can be used a second time to capture an image of the now used injection device. From this second image, data from both the first mark and the second mark are extracted and the image and data are stored with a new timestamp. The time interval between the first image and the second image identifies the time interval at which the injection was performed.

[0031] Any data captured by the application software may be transmitted (e.g., wirelessly) to a remote server for storage and processing. Subject to privacy laws and regulations, the data may be accessible to one or more of: the user's physician, the manufacturer of the administered medication, the manufacturer or assembler of the drug delivery device, insurance companies, and third-party compliance organizations.

[0032] Applicants have appreciated that the integrity and security of such systems and their function as compliance monitors would be improved if the unique numbers stored in the first and second tags were correlated and together provided a unique "fingerprint" of a separate device in both unused and used states, thereby providing positive verification that a particular device has been successfully used. In the case where the unique numbers on the first and second tags are not correlated, the system cannot detect errors or misuse by the user and may be deceived by malicious actors, such as replacing tags from other devices or counterfeiting tags. By correlating the unique numbers, such attempts will be detected and reported as errors or misuses. For the security and integrity of the system, the relationship between the numbers should be secret and not so simple that they can be discovered by the user or other actors in the use of the device. For example, if the numbers on the first and second tags are the same, the security of the system may be easily compromised because the hidden second tag will be known before use. The relationship between the unique numbers with sufficient security can be achieved by generating random numbers and maintaining a lookup table or database of the number pairs for the corresponding tags on each device at the point of manufacture.

[0033] Therefore, in another aspect of the present invention, there may be an algorithmic relationship between the unique numbers stored on the first and second marks, such that the number stored on the second mark is the result of the function operating on the number stored on the first mark. The exact algorithmic relationship may be secretly encoded in the application software, or may be accessible by the application software and known only to the system manufacturer. Once these numbers have been captured from the first and second marks respectively using one or more algorithmic operations, the application software may calculate the result of the function operating on the numbers stored in the first mark to generate an intermediate code. Once the intermediate code is calculated, the result is compared with the number encoded on the second mark. If the intermediate code matches that encoded in the second mark, the first and second marks are confirmed to be valid, and the application software records a successful injection within the time interval between the first image capture and the second image capture. Another benefit of confirming a valid code is that it provides a basic form of anti-counterfeiting protection.

[0034] In order to achieve the algorithmic relationship in the first and second markings, the unique number encoded in the first marking and the result encoded in the second marking must be arithmetically operated at the point of manufacture. This requires the ability of variable marking at the point of assembly of the drug delivery device. This can be achieved by high-speed marking techniques known to those of ordinary skill in the art, such as laser marking.

[0035] As will be appreciated by those skilled in the art, the application software may be configured to generate an intermediate code based on the second indicia (after being revealed) for verification against the number encoded in the first indicia.

[0036] The specific algorithmic relationship used to associate the first mark and the second mark can have different complexities. In order for this scheme to produce a unique fingerprint for each device, the function should be single-valued so that the operation of the function on the input produces a single unique numerical result. More complex functions will provide greater protection against attempts to discover the secret function, however, there are limitations related to the data storage density of the optical encoding and the size of the mark when selecting the function, which sets an upper limit on the size of the numbers that can be reliably stored. Optical encodings such as QR codes can store data in different formats such as characters, numbers, binary, etc., and can utilize different degrees of error correction with the help of redundancy, which reduces the amount of data that can be stored. The selection of the optimal storage format requires a trade-off between the degree of error protection, the available area of ​​the mark, the camera resolution, and the amount of data to be stored. Preferably, the inputs and results of the function are integers to minimize the size of the optical encoding required to store them.

[0037] For the purpose of illustration, a very simple algorithmic relationship can be to simply subtract the unique number of the first tag from a constant secretly encoded in the application software. If the number of the first tag is an integer A, and the constant is an integer C, then CA=B, where B is the integer result (intermediate code) that matches the number encoded in the second tag. C can be arranged to be greater than A so that the result B is a positive integer, so that the positive and negative signs can be ignored. The size of the corresponding number will be determined by the encoding constraints of the optical tag used. If the unique number encoded in the first tag is also used as a unique serialization of the production unit, the size must be selected to be sufficient to uniquely number all expected productions. Since the area used for the second tag (due to concealment constraints) is typically less than the area used for the first tag on the device body, it is preferred to arrange the numbers so that the result to be encoded in the second tag requires less optical storage than the first tag.

[0038] For the purpose of illustration with specific example numbers, assume that A is the randomly selected decimal integer 21432364, and C is 25432449 (also decimal and randomly selected). Then the result CA=B=4000085 is the number to be encoded in the second marking. This calculation is performed by the assembly equipment at the assembly point, and the result is encoded into the second marking applied to the traveling component. At the point of use, the inverse function is performed by the application software, which is the addition B+A. If the result of the addition is equal to C, the code is valid and is confirmed. In the example, 21432364+4000085=25432449, and the result is confirmed.

[0039] More generally, the algorithmic relationship f between the first mark A and the constant C is f(A)=CA. The inverse function g is g(A,B)=B+A. It should be noted that the encoded numbers are not limited to being in base 10, and other bases such as binary, octal or hexadecimal may be used, and more efficient optical storage may be allowed. It should be understood that the foregoing is provided for illustrative purposes only, and is an example of an infinite number of possible algorithmic relationships that may be utilized within the above constraints. Nevertheless, despite its simplicity, assuming that the constant C is randomly selected and kept confidential, even with such a simple function, the degree of validity confirmation may be sufficient for most normal purposes. However, for counterfeit protection, if a counterfeiter can obtain multiple samples of a used device, in which case the algorithmic relationship is easily discovered, a more complex algorithmic relationship is preferred for stronger anti-counterfeiting measures.

[0040] In an embodiment, the secret function can be an encryption password that converts some or all of the data stored on the first mark into an encrypted form written to the second mark. In cryptographic terms, the data from the first mark intended for encryption will constitute "plaintext", while the encrypted data intended for writing the second mark will constitute "ciphertext", or vice versa. Broadly speaking, encryption mechanisms are divided into "symmetric" and "asymmetric" methods. Symmetric methods require a single password, passcode or "key", while asymmetric methods implement so-called public key encryption and require two keys: a public key and a private key. The standard algorithms for these two types of encryption are known to those of ordinary skill in the art and are widely used. Generally, asymmetric encryption provides stronger encryption and also provides the possibility of signing data using electronic signatures; however, they are more complex and require management of public and private keys. One of the advantages of using standard encryption passwords as secret functions is that they typically use random seeds when generating ciphertexts, which makes the password safer and makes it more difficult to find secret functions in the context of the present invention. However, one of the disadvantages of such algorithms is that the ciphertexts may be significantly larger than the plaintexts that generate them. In addition, due to the random seeding of the encryption algorithm, the length of the ciphertext may be unpredictable. Due to optical encoding constraints caused by restrictions on the available area for applying the second mark to the traveling component and limitations on the accuracy of the marking technology and camera resolution, the unpredictable size of the ciphertext may prevent the ciphertext from being encoded in the second mark. Simpler encryption algorithms are known, such as simple substitution algorithms, in which the plaintext and ciphertext are guaranteed to have the same length, however, these algorithms may not provide more protection for secret function discovery than the simple example described above. The present invention does not strictly require encryption of optically encoded data. Instead, a unique code pair is required to provide a fingerprint of the used and unused states of a separate device. This only requires that the algorithmic relationship between the two marks is maintained in secret. Since the algorithmic relationship is not directly encoded in either mark, encryption is not strictly necessary, and therefore the benefits of standard encryption algorithms when used as a secret function may be offset by these disadvantages.

[0041] However, preferably, the algorithmic relationship should be difficult to be discovered to avoid compromising the integrity of the system. To address this problem, in other embodiments, elements of other data fields stored on the first tag (such as manufacturing date and / or time and manufacturing batch number) can be used to generate stronger confidentiality in the algorithmic relationship, because the use of variable inputs rather than the constants described in the previous examples introduces randomness or pseudo-randomness elements, which makes the secret function more difficult to be discovered. An example of how this can be achieved is by using a cryptographic hash algorithm. An ideal hash algorithm is designed to produce a unique output for a given input, which is called a "digest" or "hash value". Therefore, in a strict mathematical sense, a hash algorithm can be regarded as a single-valued function. This characteristic makes such algorithms suitable for creating a unique "fingerprint" of input data, which is useful for checking the integrity of the data, since any modification to the input, whether unintentional (e.g. due to transmission errors) or intentional (such as tampering by a malicious actor), results in a different fingerprint. Another characteristic of hash algorithms is that they produce an output string of fixed length, regardless of the length of the input. This characteristic facilitates optical encoding, since the number of data bits to be encoded, and therefore the size of the optical code, is always fixed and known in advance. A final characteristic of a hash value is that it is essentially impossible to reproduce the data from the hash value itself. In practice, this means that no inverse hash function can be used to retrieve the data and aid in discovering secret functions, as in the simple subtraction function example above. Hash algorithms are widely used in computing and cryptography, and are known to those of ordinary skill in the art. Some well-known hash algorithms are the MD4, MD5, SHA1, and SHA256 algorithms.

[0042] Although the hash can be reliably reproduced from a given input, the hash value itself is an obfuscated alphanumeric string that appears random and meaningless. This feature makes hashing suitable for obfuscating input data to prevent discovery of secret encoding schemes.

[0043] In order to use the hash algorithm in the present invention, it is not enough to simply generate a hash value from the data stored on the first tag and write it to the second tag, because the data on the first tag is available before use, and in principle, the hash value (and therefore the tag) for the second tag can be correctly and reliably generated before the device is used, thus enabling the application software to record "wrong use" for unused devices. Therefore, it is still necessary to perform a secret mathematical function or other conversion operation on some or all of the data of the first tag. However, once the result is calculated, the result is passed through the hash algorithm together with some or all of the other data on the first tag to generate a hash value written to the second tag. This produces a reliable but undiscoverable algorithm encoding between the first tag and the second tag. Assuming that some of the data encoded in the first tag is variable and semi-random, such as the manufacturing time, the confidentiality and security of the hash value are further enhanced. In addition, because the hash value always has a fixed length, the above-mentioned ciphertext size vs. plaintext size problem is eliminated when the encryption algorithm is used as a secret function. Therefore, in one embodiment, the second tag can encode the hash value of the ciphertext of the first tag. The key to the encryption algorithm will be kept as a secret in the smartphone application.

[0044] In yet further embodiments, applicants have recognized that it may be advantageous for application software to generate hash values ​​of captured images of unused and used devices, for example, to address the possibility of "double capture", where a user or malicious actor captures multiple images of the same device in a used or unused state and attempts to reuse them. The hash value generated from the image file can be considered an image-unique fingerprint that uniquely identifies the image. This relies on the sensitivity of the hash algorithm to the input data. For all practical purposes, it is unlikely that two different image captures of the same scene are sufficiently identical that the hash algorithm will produce the same hash value as a result. For example, a slight difference in lighting results in a small number of pixels with different colors and intensities, which will be enough to change the hash value result, thereby producing a different fingerprint. If the image file from which the hash value is generated includes metadata such as EXIF ​​data (which records, for example, the time and date of image capture), the file is guaranteed to produce different hash values. The image and the calculated hash value can then be used in the smartphone application and the extended system to provide a high degree of verification of the authenticity of the image capture and its capture time and date. If geolocation is enabled in the camera application and recorded in the image metadata, the location can also be verified.

[0045] It should be noted that the first number encoded in the first optically readable code and the second number encoded in the second optically readable code can be algorithmically related. As discussed above, one or more algorithms based on mathematical operations and / or encryption techniques can be used to relate the first number and the second number. The mathematical operation can be one or more basic operations involving a predetermined value (such as the constant C discussed above), including subtracting a predetermined value, adding a predetermined value, multiplying a predetermined value, and dividing a predetermined value. As discussed above, the one or more algorithms can be programmed into the application software together with any necessary predetermined values.

[0046] In addition, the application software can be configured to decode the data bits or data strings from one or both of the first and second marks to obtain a key for determining the algorithmic processing to be performed. In this arrangement, the application software can have a lookup table associated with it, wherein a plurality of algorithmic operations are associated with different keys. During the manufacturing process, a key is selected based on one or more algorithms for determining the second number, wherein the relevant key is encoded in the first mark and / or the second mark. When the first mark and the second mark are decoded, the key is obtained and used to determine the relevant one or more algorithmic operations. This allows a certain degree of randomness in the algorithmic application. As another alternative, the first mark or the second mark can include a link to a remote database (e.g., an IPV6 Internet address, etc.), wherein the remote database stores a plurality of algorithmic operations associated with different keys. The application software can be configured to call a remote database with a decoded key to identify the relevant one or more algorithmic operations.

[0047] When the data stored on the first and second markers are aggregated, the results of the algorithmic confirmation, the time interval between image captures, and the user "key" provide confirmation that the device was successfully used by a particular user during the recorded time interval without the need for any electronics beyond the user device itself. The data can then be transmitted to a remote database managed by a service provider and can be subject to further analysis. The analysis can include compliance with the dosing regimen or device failure (such as an incomplete injection). As an example of such an analysis, a long time interval between the first image capture and the second image capture may indicate that the user is having difficulty and that additional training is required. A healthcare provider may be alerted to such a trend to enable appropriate intervention.

[0048] In another embodiment of the present invention, another hidden mark can be applied to other parts of the drug delivery device that are hidden in the unused state and revealed in the used state. For example, some injection devices have a needle shield that is deployed and locked in place at the end of the injection to prevent needlestick injuries from the used device. In such devices, the third mark can be hidden on the hidden part of the shield component to reveal when deployed. Now, instead of the coding pair on the first mark and the second mark, there are three groups of codes that can be algorithmically related. Alternatively, this can be regarded as a one-to-many relationship between the first mark and the hidden (second and third) mark. In principle, this can be extended to any number of hidden marks that generate n groups of codes, but in practice, the number of such codes that can be used will be limited. The mathematical definition of the function requires that it is single-valued, which is a feature used in the first embodiment described including the first mark and the second mark, so as to ensure that a unique result is obtained. Although not a mathematical function in the strict sense, multi-valued functions are known, but in the implementation of the one-to-many relationship between the codes, their use may have too many restrictions. In many cases where multiple hidden markers may be used, they will be revealed as part of a defined sequence of actions. For example, in an injection device with a deployable needle shield, a first marker is visible when the device is removed from its packaging, a second marker is revealed when the injection is completed, and a third marker is revealed when the needle shield is deployed. Such a sequence of actions can be encoded by a sequence of applications of the same hidden function, where the same function is applied to the result of the previous application of the function in the sequence. This "chaining" of functions together ensures that a strict sequential functional relationship is maintained between the encodings on each marker in the chain. As in the original example of two markers, the algorithmic relationship should not be discoverable. In fact, in the case of more than two markers, this requirement is even more stringent because there are now multiple results of the application of the function on a single device.

[0049] To provide a simple example of how such chaining of functions may work, refer to the previous example of a simple subtraction function, where the function f(A)=CA=B, where C is a secret constant. In the case of three tags, the encoding of the third tag is obtained as f(B)=CB=D. More generally, if the number encoded in the i-th tag is Xi, then f(Xi)=C-Xi=Xi+n. As mentioned above, although illustrative, this example may be too simple to meet the requirement of being undiscoverable. In order to provide an undiscoverable encoding chain, hash functions can be chained together to generate a "hash value chain", where starting with the data encoded in the first tag and the seed data obtained by the operation of the secret function thereon, the hash algorithm is applied and the result is written to the second tag. This process is repeated the same number of times as the number of tags required, so that the result of the first application of the secret function and hash algorithm is written to the second tag and becomes the input to the next application of the secret function and hash algorithm, and so on, until all tags have been encoded.

[0050] In symbols, if the hash function is h, the secret function is s, and the seed data is S, then the first hash value encoded in the second tag is h(s(S)), and the second hash value encoded in the third tag is h(s(h(s(S))), which can be more conveniently written as h^2(s^2(S)). In the general case, the nth hash value encoded into the n+1th tag is h^n(s^n((S)). Because the hash function does not have an inverse function, the verification of the authenticity of the nth hash read from the nth tag is to calculate h(s(Sn-1)), where Sn-1 is the hash value stored in the n-1th tag and compared with the hash value read from the nth tag.

[0051] In this scenario, applying tags to traveling components would require tagging these components according to the encoding scheme described above, so that chains of hash values ​​would be calculated sequentially during the assembly process and applied to the corresponding components in an extension of the double tagging scheme.

[0052] In the case where the drug delivery device is a medical syringe, the second mark can be revealed by the automatic movement (such as with the movement of the traveling part) of the device, in particular as a part of the injection. In the different forms of the drug delivery device, the revealing can be caused by the manual action of the user, for example, when opening a pill bottle or opening the sealed blister of a blister package. By this type of arrangement, the second mark is concealed, and the normal manual interaction of the user is utilized to reveal the second mark, for example, with the manual opening of a pill bottle and the manual opening of the blister of a blister package. A peelable covering can also be provided for the second mark, and when the user peels off the covering, the covering is removable, to reveal the second mark. By this arrangement, the second mark can be located on the external part of the drug delivery device, without the need for physical concealment by a part of the drug delivery device. It should be noted in addition that the details of this paragraph are applicable to all concealed marks, to be revealed (such as the third mark discussed above). For two or more concealed marks, concealed modes can be mixed, for example, with the movement on the medical syringe automatically revealing the second mark and manually peeling off the covering on the syringe body to reveal the third mark. The revealing of the second marking can be utilized alone without using the first marking. The revealing of the second marking provides an indication of dose completion and can provide useful information independent of the first marking or any other optically readable code.

[0053] In one approach, the manufacturing process flow in these scenarios can involve: optically encoding data to produce a first mark during the assembly of the drug delivery device, and applying the mark to the outer surface of the drug delivery device; applying one or more algorithmic operations to generate data for a second mark; encoding and writing the second mark; and applying the second mark to the drug delivery device. It should be noted that the first mark applied to the external portion of the drug delivery device can be applied at various stages of the manufacturing / assembly process, including when the drug delivery device is fully assembled. The second mark, because it is concealed, may need to be applied to a component of the drug delivery device before or during assembly when the necessary accessibility is available. For example, in the case where the drug delivery device is a medical syringe, the second mark can be applied to the travel component (e.g., plunger) before or during assembly because the travel component may be contained and inaccessible after assembly.

[0054] In some cases, it may be beneficial to mark the components of the drug delivery device with a unique number or code of a second mark before final assembly, when in its batch form, such as by laser marking as a final step in its manufacture (typically by injection molding). During the final assembly process, when each individual component enters the assembly process, the number or code can be read therefrom. Then, the secret function will operate on this number or code as input to generate a result (by applying one or more algorithmic operators related), and the result will be written to the first mark for application on the external body of the device. This method has the advantage of avoiding the need to mark the components with the unique code of the second mark during the assembly process, and writing the result to the first mark that may have a larger data storage capacity. However, this method may set some constraints on the secret function that can be used, because the direction of the encoding is now from the second (hidden) mark to the first mark. For example, due to the limited optical data storage available in the second mark, variable data such as time and date may not be used when calculating the result for encoding the first mark. Medical syringe

[0055] Reference Figure 1-Figure 29 , the drug delivery device of the present invention is shown in the form of a medical syringe 100 .

[0056] The medical injector 100 may be of any known type. The present invention is particularly suitable for use with a pen injector. Figure 1-Figure 9 The medical injector 100 is representatively shown as a pen injector. The medical injector 100 may generally include a body 102, a drug reservoir 104 contained within the body 102, a cannula 106, and a movable plunger 108 for urging the drug from the drug reservoir 104 through the cannula 106. The drug reservoir 104 is configured to contain a supply of drug 105. As is known in the art, the drug reservoir 104 may be a stoppered ampoule. Figure 2-Figure 3 As shown, the plunger 108 can be configured to press against and displace the stopper 107 in the ampoule to push the drug from the ampoule. The cannula 106 can be pre-installed on the medical syringe 1004 or equipped with mounting features such as threads or Luer connectors that are configured to cooperatively mount to corresponding features on the body 102. The cannula 106 can access the contents of the drug reservoir 104 using any known configuration, for example, by installing the cannula 106 to the body 102 to break the septum 109 provided on the drug reservoir 104.

[0057] The medical syringe 100 may be provided as a single-use syringe configured for a fixed dose, wherein the distal end 111 of the plunger 108 has a predetermined travel length. Alternatively, the medical syringe 100 may be provided as a variable dose device utilizing any known dose setting mechanism. When the dose is set, the distal end 111 of the plunger 108 is set to translate a distance set by the selected dose. As indicated, the plunger 108 is moved in a predetermined travel length. Figure 1-Figure 3 Schematically shown in FIG. The plunger 108 can be of a fixed length type, which is advanced by applying pressure to its proximal end (the proximal end is away from the cannula) or by using a threaded or geared drive (e.g., in the form of a lead screw). Alternatively, the plunger 108 can be of an extended length type, such as a telescopic plunger that is caused to become longer. The plunger 108 is configured to advance the distal end 111 in the distal direction toward the cannula 106.

[0058] The body 102 is provided with an open window 110 that allows visual access to the interior of the body 102. The open window 110 may be an open, hollow hole with no material therein, or may be provided with a transparent or translucent lens. Preferably, the body 102 is formed to be opaque, thereby limiting visual access around the open window 110. A first indicia 112 may be applied to an exterior portion of the body 102 outside the open window 110. A second indicia 114 may be located on the plunger 108 such that, in a pre-use state, the second indicia 114 is concealed by a portion of the body 102, such as in Figure 2 The plunger 108 and the open window 110 are configured such that the second indicia 114 is revealed through the open window 110 as the plunger 108 advances a dose from the drug container 104 through the cannula 106. The advancement of the plunger 108 when delivering a dose will cause the second indicia 114 to transition from a concealed state to an exposed state visible through the open window 110, as shown in FIG. Figure 3 For simplicity, Figure 1-Figure 3 1 is shown schematically, and not all components of the medical syringe 100 are shown. As will be appreciated by those skilled in the art, Figure 1-Figure 3 Sufficient detail is provided to convey the essence of the invention.

[0059] like Figure 4-Figure 6 As shown, the body 102 can be elongated to extend along the longitudinal axis. The first marker 112 and the second marker 114 can be positioned at positions spaced apart along the longitudinal axis. This allows good alignment of the first marker 112 and the second marker 114 in the common field of view of the camera of the user device 116.

[0060] In use, such as Figure 4As shown, a user device 116 having application software stored thereon can be used to capture an image of the medical syringe 100 prior to use. The captured image of the medical syringe 100 can be time-stamped by the application software for reference. As discussed above, the application software can be configured to use machine vision algorithms (such as pattern matching, template matching, or feature matching) to confirm that the medical syringe 100 is properly in a pre-use state. For example, the application software can be configured to identify the open window 110 and expect to see a specific color field defined by the open window 110. The color can be provided by the drug 105 to define the color field, particularly in the case where the drug reservoir 104 has transparent or translucent side walls. Additionally or alternatively, in the case where the drug 105 is transparent or translucent, a portion 117 of the interior of the body 102 opposite the open window 110 can have a color so as to be viewable as a color field by the camera of the user device 116. The full view of the expected color field provides an indication of the proper pre-use state, with the plunger 108 being completely out of view. For example, as Figure 4 As shown, the field within window 110 is displayed entirely as a single color (white). If the color field is partially or completely obscured, for example, the area is not entirely a single color, the application software can detect a possible error and provide an indication to the user for manual confirmation.

[0061] Once it is determined that the medical syringe 100 is ready for use, Figure 5 As shown, a medical injection can be performed. The cannula 106 can initially be covered by a needle shield 118, which can be retracted as the medical syringe 100 is pressed against the injection site. Alternatively, the cannula 106 can be exposed, not covered, and directly inserted into the patient's body at the injection site before use. In the case where the cannula 106 is inserted at the injection site, any known arrangement for driving the plunger 108 for administration can be utilized. As known in the art, the plunger 108 can be propelled by a force physically applied by a user and / or by releasing a power provided by a spring, compressed gas, etc.

[0062] like Figure 6 As shown, when the injection is completed, the plunger 108 is in a post-use state, wherein the second mark 114 is revealed through the open window 110 (as shown in FIG. Figure 3). The user device 116 can be used to capture a post-use image in which the first mark 112 and the second mark 114 are in a common field of view of a camera of the user device 116. This captured image can be time-stamped by the application software for reference. Similar to pre-use processing, the application software can utilize machine vision algorithms to confirm the proper post-use state of the medical syringe 100. For example, the plunger 108 can be set to a color that contrasts with the color of the original color field. Using image capture, the application software can view the color within the open window 110 to compare the visible color field with the expected color field when determining whether the plunger 108 has fully completed its travel.

[0063] The first tag 112 and the second tag 114 can be decoded by the application software to read the data captured therein. As discussed above, the first tag 112 and the second tag 114 can include unique numbers that are algorithmically related, as discussed above. In this way, the first tag 112 and the second tag 114 can be jointly verified. Once verified, the application software can create a data packet including a timestamp of the images captured before and after use and an indication that the injection was successfully completed for transmission to a remote server for review and analysis.

[0064] It should be noted that, as discussed above, the second indicia 114 may be physically smaller than the first indicia 112, particularly due to space constraints within the medical injector 100. Thus, the amount of encoded data in the second indicia 114 may be less than the amount of encoded data in the first indicia 112.

[0065] It should be noted that there may be glare or reflections within the open window 110, particularly if a lens is provided, which may affect the ability to decode the second indicia 114. The application software may be programmed to detect such anomalies and request or suggest repositioning the medical injector 100 and / or user device 116 to seek to establish a different line of sight, which may reduce or eliminate the glare or reflections.

[0066] like Figure 7-Figure 9 As shown and as discussed above, the medical syringe 100 can use more than two additional markings. The needle shield 118 can be provided with a third marking 120, which is concealed before use. Similar to the second marking 114, the third marking 120 can be covered and concealed by a portion of the body 102. It should be noted that the needle shield 118 can be completely retracted within the body 102 before use. With this arrangement, the needle shield 118 does not cover the cannula 106 before use. As discussed above, alternatively, the needle shield 118 can protrude from the body 102 before use to cover the cannula 106. In either case, the third marking 120 is concealed within the body 102 before the rear cover is used.

[0067] Figure 7 The medical syringe 100 is shown in a pre-use state as discussed above, and Figure 8 The medical syringe 100 is shown in a post-injection state as discussed above. Fig. 9 The needle shield 118 is shown in a deployed state, wherein the cannula 106 is covered after use. In the deployed state, the third marker 120 is revealed. Preferably, the third marker 120 is positioned along the same longitudinal axis as the first marker 112 and the second marker 114. In this way, the user device 116 can capture the post-use image of all three of the first marker 112, the second marker 114 and the third marker 120 in the common field of view of the camera of the user device 116. The data can be decoded and utilized in the same manner as discussed above. A fourth additional marker, for example, located outside the body 102 with a peelable cover can be used.

[0068] The needle shield 118 may be formed in any known manner, particularly to be released during or after an injection. The needle shield 118 may be spring biased and urged forward to cover the cannula 116 when released from the patient's skin at the injection site.

[0069] For a typical pen-type injector, the drug reservoir 104 is an ampoule. With the insertion of the plunger 108, the drug is pushed out from the ampoule. The second mark 114 can be pushed into the interior of the ampoule with the distal advancement of the plunger 108. The side wall of the drug reservoir 104 can be formed to be transparent or translucent to allow the second mark 114 in the drug reservoir 104 in the post-use state to be visually seen.

[0070] In an alternative embodiment, the medical syringe 100 may be in the form of a syringe barrel, such as Figure 10-11 As shown. The body 102 may be in the form of a cylinder, wherein the drug 105 is contained. The plug 107 may be mounted directly to the plunger 108, wherein the plug 107 is in sealing contact with the body 102. The plug 107 and the body 102 define a drug reservoir 104 in combination. As the plunger 108 is advanced distally, the plug 107 pushes the drug 105 through the cannula 106.

[0071] like Fig.11As shown, an open window 110 can be defined in the body 102 as part of the barrel. The body 102 can be opaque around the open window 110. In the case where the body 102 is formed of glass, as is typical of syringe barrel construction, the body 102 can have a decal or coating applied to its exterior, which is frosted or otherwise shielded to provide opacity to the body 102. In contrast, the open window 110 does not have a decal or coating and is thus transparent. This embodiment generally operates in a manner similar to the pen-type injector embodiment described above, wherein the second marking 114 is located on the plunger 108 to be revealed through the open window 110 after use.

[0072] In other embodiments, the medical injector 100 may be in the form of a body-wearable injector, such as Figure 12-Figure 29 As shown. Fig.12 As shown, the body 102 of the medical syringe 100 can be in the form of a shell that can be retained on the patient's skin by an adhesive, a strip, or other retaining arrangement. The body 102 can be box-shaped and have an adhesive layer 122 on its base surface 124. As is known in the art, the adhesive 122 is configured to be releasable from the skin after injection. Fig.13 As schematically shown in FIG. 1 , a body-wearable injector known in the art has an internal drug reservoir 104 with a plunger 108 for pushing the drug from the reservoir 104 to the cannula 106 via one or more connectors (e.g., one or more conduits 128). As is known in the art, and as discussed above, the reservoir 104 may be sealed at one end by a stopper 107. For a typical body-wearable injector, the cannula 106 is concealed within the body 102 prior to use. Fig.12As shown, the cannula 106 is caused to extend from the body 102 through the base surface 124, wherein the body 102 is fastened to the patient. The cannula 106 can be automatically or manually driven to extend from the body 102, as known in the art. A motor or other drive mechanism 121 contained in the body 102 can be provided to drive the plunger 108 to dispense the drug through the cannula 106, particularly when the cannula 106 is inserted into the patient's skin. After injection, the cannula 106 can be retracted (e.g., automatically retracted) into the body 102. A controller 123 (such as a computer processing unit, etc.) can be provided to control the medical injector 100 (including the cannula 106 and / or the motor 121). A supply of electrical energy 119, such as in the form of a battery, can be provided, which is contained in the body 102 and is electrically coupled to provide electrical energy to various components of the medical injector 100 (including but not limited to the motor 121 and the controller 123). One or more switches 129 can be provided to allow the user to control the medical injector 100, including enabling activation. Although not shown, one or more switches 129 are typically accessible from the outside on the body 102, such as in the form of one or more buttons, to allow user interaction. As will be appreciated by those skilled in the art, the body-wearable injector may include additional or different features than those described herein. It should be understood that the principles of the present invention will apply equally to body-wearable injectors of different configurations.

[0073] In one variation, Figure 14-16 As shown, the first indicia 112 can be disposed on the body 102. A release liner 126 can be provided to cover the adhesive 122 prior to use. The release liner 126 is peelable to expose the adhesive 122, thereby allowing the body 102 to be adhesively applied to the patient's skin at the desired injection site. The first indicia 112 can be disposed on the adhesive 122, or the adhesive 122 can be discontinuous, wherein the first indicia is located in a discontinuous portion between the adhesive 122 portions.

[0074] As with other variations of the medical syringe 100, an open window 110 may be provided on the body 102, and a second indicia 114 may be provided on the plunger 108. Figure 17-Figure 18As shown, the open window 110 can be positioned to allow the second indicia 114 to be aligned with the open window 110 so that it is viewable through the open window at the end of the injection (i.e., the full travel of the plunger 108). The open window 110 can be set on the outer face 130 of the body 102, facing in a direction opposite to the base face 124. With this arrangement, the first indicia 112 and the second indicia 114 will be separately viewable (located on opposite faces of the body 102). The first indicia 112 can be included on the outer face 130, and the first indicia is positioned to be in a common view of the camera of the user device 116. Here, the first indicia 112 will be exposed and not covered by the release liner 126. Alternatively, as Figure 19-20 As shown, the open window 110 can be disposed on the base surface 124, for example, in a discontinuous portion between portions of the adhesive 122. Here, the second mark 114 can be initially positioned to be misaligned with the open window 110 ( Fig.19 ) and is positioned to align with the open window 110 at the end of the injection ( Fig. 20 ). In addition, the opening window 110 can be located on the base face 124 so as to be in common view of the camera of the user device 116 with the first indicia 112 (thereby allowing the first indicia 112 and the second indicia 114 to be in common view of the camera of the user device 116). With the opening window 110 on the base face 124, the first indicia 112 can be hidden by the release liner 126 prior to use. As with other variations of the medical syringe 100, the capture of the first indicia 112 and the second indicia 114 allows for timestamping (e.g., at the start and end of an injection) and / or provides an indication of the success and completeness of the injection.

[0075] As another variation, the second mark 114 can be provided on the body 102 separately from the plunger 108, for example, on a support surface 125 aligned with the open window 110. The support surface 125 can be spaced apart from the open window 110. The shielding panel 127 is provided with an initial state of covering the open window 110 to shield the second mark 114. The shielding panel 127 can be adjusted to a second state, not covering the open window 110 to expose the second mark 114. In one variation, as Figure 21-24 As shown, the first indicia 112 can be disposed on the obstruction panel 127. The opening window 110 is shown as being located on the base surface 124, but may also be located elsewhere on the body 102. Again, in the case where the opening window 110 is located on the base surface 124, the first indicia 112 can be obscured by the release liner 126 prior to use. Fig.21 As shown, initially, the first mark 112 is visible through the open window 110, and the initial position coincides with the time before or at the beginning of the injection (at Fig. 22 ). Fig.23As schematically shown in FIG. 1 , at the end of the injection, the shielding panel 127 is adjusted to the second state. Fig.24 As further shown in FIG. 1 , the second indicia 114 is revealed and viewable through the open window 110 , wherein the first indicia 112 is hidden and not viewable, being obscured by a portion of the body 102 .

[0076] Any arrangement that causes the obstruction panel 127 to adjust from the initial state to the second state may be utilized. By way of non-limiting example, Figure 25-27 As shown, the shielding panel 127 can be urged to the second state, for example, by the spring 132, wherein the retainer 134 holds the shielding panel 127 in the initial state. The retainer 134 is caused to allow the release of the shielding panel 127, thereby causing adjustment to the second state. The retainer 134 can be in the form of a displaceable or rotatable finger, which is positioned to overlap with a portion of the shielding panel 127, such as Fig.25 As shown. The shielding panel 127 may be hingedly connected to the body 102 or may slide relative to the open window 110. The retainer 134 acts to limit the rotational or sliding movement of the shielding panel 127 from the initial state before release. Figure 26-Figure 27 As shown, the retainer 134 can be caused to adjust (translate or rotate) when the injection is complete (e.g., the plunger 108 has completed its entire travel) or when the cannula 106 is retracted into the body 102. The retainer 134 can be caused to adjust by the controller 123 or by a mechanical connection (direct or indirect connection) between the retainer 134 and the plunger 108 or by a mechanical connection (direct or indirect connection) between the retainer 134 and a component of the cannula 106. However, the arrangement mentioned does not allow for simultaneous viewing of the first mark 112 and the second mark 114. In an alternative arrangement, such as Figure 28-Figure 29 As shown, the opening window 110 can be provided separately from the first mark 112. In the same manner as previously described, the shielding panel 127 initially covers the second mark 114 ( Fig.28 ), and when the shielding panel 127 is released, the second mark 114 ( Fig.29 ).like Fig.29 As shown, with this arrangement, the first marker 112 and the second marker 114 are viewable in a common view of a camera of the user device 116 .

[0077] After injection, when the cannula 106 is retracted into the body 102, and when the body 102 is removed from the patient's skin, the cannula 106 will be hidden within the body 102. Therefore, the cannula 106 will not affect any viewing of the first and second markings 112, 114, particularly when viewable on the base surface 124.

[0078] like Figure 14-16As shown, the third mark 120 can be set on the release liner 126, particularly on its outer surface, so that it can be viewed before removing the release liner 126 to expose the adhesive 122. The third mark 120 can be captured before use. This allows an initial read to confirm the readiness state. For example, the third mark 120 can be captured by a camera of the user device 116, wherein the third mark 120 is decoded by the application software to obtain the start data. This reading can provide a timestamp to indicate the start time. The data obtained can also be used as a key required to allow the activation of the medical injector 100. The data can be transmitted by the user device 116 to a receiver (e.g., a receiver associated with the controller 123) on the medical injector 100, and then the receiver allows the medical injector 100 to be activated using the controller 123. The key can be used as a fail-safe device to prevent premature activation. Subsequently, the first mark 112 and / or the second mark 114 can be used to provide data about the injection status (start, completion, etc.).

[0079] As will be appreciated by those skilled in the art, the medical injector 100, whether in the form of a pen injector, a syringe, or a body wearable injector, can utilize the second indicia 114 without the first indicia 112 and / or the third indicia 120. Here, the second indicia 114 will be revealed due to the injection, as discussed above. The second indicia 114 can be optically read alone and provide useful information. Pill Bottle

[0080] Reference Figure 30-Figure 33 , the drug delivery device may be in the form of a medical pill bottle 200. The pill bottle 200 includes a standard construction having a reservoir 202 having a base 204 bounded by an upstanding sidewall 206. The reservoir 202 defines an interior volume 210 to accommodate a supply of medical pills 208. The sidewall 206 terminates in a free end 212 that defines an opening 214 in communication with the interior volume 210. The opening 214 provides access to the interior volume 210 to allow removal of the medical pills 208.

[0081] A cap 216 is mounted to the sidewall 214 across the opening 214. The cap 216 is movable between an open state that allows access to the interior volume 210 through the opening 214 and a closed state that completely covers the opening 214. Fig.30 As shown, the cap 216 can be displaced by being removed from the side wall, for example, where the cap 216 is threadedly mounted to the side wall 206 around the opening 214. The cap 216 can be provided with child-resistant features, as is known in the art. Alternatively, as Figure 31-Figure 32As shown, the cap 216 can be multi-component, including a first cap portion 216A mounted to the side wall 206 and a second cap portion 216B that can be moved relative to the first cap portion 216A to shift between an open state and a closed state. The second cap portion 216B can be hingedly connected to the first cap portion 216A to rotate between an open state and a closed state. The first cap portion 216A and the second cap portion 216B can be provided with a cooperating, releasable engagement member to releasably secure the second cap portion 216B to the first cap portion 216A in the closed state (e.g., a cooperating snap-fit ​​engagement feature).

[0082] The second mark 114 can be set on the lower surface 218 of the cap 216. In this way, the second mark 114 is concealed by the cap 216 in the closed state. When the cap 216 is in the open state, the second mark 114 can be revealed. In the case where the cap 216 is multi-part, the second mark 114 can be located on the lower surface 218 of the second cap portion 216B. The first mark 112 can be applied to the outer portion of the reservoir 202. The reservoir 202 can be elongated to extend along the longitudinal axis. Preferably, the first mark 112 and the second mark 114 are positioned at positions spaced apart along the longitudinal axis. This allows good alignment of the first mark 112 and the second mark 114 in the common field of view of the camera of the user device 116.

[0083] In use, the image of the pill bottle 200 in the closed state can be captured using the user device 116. The application software can add a time stamp to the captured image. The cap 216 is shifted to the open state (by removing or adjusting the second cap portion 216B), wherein one or more of the medical pills 208 are removed from the inner portion 210 depending on the required dosage. When the cap 216 is in the open state, the user device 216 can be used to capture the post-administration image of the first mark 112 and the second mark 114. In the case of being removed, the cap 216 can be placed adjacent to the reservoir 202 to allow the first mark 112 and the second mark 114 to be in the common field of view of the camera of the user device 116. The application software can perform verification of the first mark 112 and the second mark 114, as discussed above. The image can be time stamped. The application software can generate a data packet based on a timestamp and / or verification for transmission to a remote server.

[0084] It should be understood that in the case of pill bottle 200, first mark 112 and second mark 114 are static, wherein the same code is used to verify multiple doses. Due to its repeated use, this may allow forgery of medication information. The availability of timestamps and remaining doses at remote locations provides some basis, and the legitimacy of collected data can be verified by comparing with the expected medication schedule. In addition, or alternatively, the hash value of each captured image can also be calculated, thereby generating a unique hash value for each opening of the pill bottle 200 (each opening represents a separate medication). The generated hash value can be used to verify that the pill bottle 200 has been opened for this number of times (at least this number of times, the opening of the uncaptured image is undetectable, but this can be solved by a coordination error in counting the medical pills 208, assuming that the medical pills 208 are consumed when they are not captured). This coordination error can be used to detect non-compliance and trigger intervention. Blister Packaging

[0085] Reference Figure 34-Figure 37 , the drug delivery device can be in the form of a medical pill blister package 300. The blister package 300 includes a standard construction in which a plastic layer 302 is formed to define an array of blisters 304. Each blister 304 is formed to accommodate at least one medical pill 306. The plastic layer 302 can be formed using any technology including injection molding, thermoforming, etc. A foil layer 308 is fastened to the plastic layer 302 to cover the blisters 304. The foil layer 308 can be any material suitable for sealing the blisters 304, including but not limited to coated paper and aluminum. The foil layer 308 can be fixed to the plastic layer 302 using any known technology, including but not limited to adhesion, heat welding, etc. As known in the art, the foil layer 308 can be thinned or scored around the blisters 304, and / or provided with child-resistant features to limit access to the blisters 304.

[0086] like Fig.35 As shown, the foil layer 308 includes an area that is not aligned with the blister 304. The first indicia 112 is located outside of the foil layer 308 and is not aligned with the blister 304. In this way, as the medical pills 306 are successively removed from the blister 304, the first indicia 112 remains intact.

[0087] like Fig.37 As shown, a second mark 114 is provided in each blister 304, particularly at the bottom thereof. With this arrangement, the second mark 114 is revealed as the corresponding blister 304 is approached and the pill 306 is removed therefrom. In the case of the pill bottle 200, the second mark 114 is revealed as it is opened. In contrast, in the case of the blister package 300, the blister 304 needs to be approached and the pill 306 must be removed to reveal the second mark 114. This provides greater integrity in ensuring drug administration.

[0088] In use, the user device 116 is used to capture an image of the first marker 112 before approaching one of the blisters 304 to administer the drug. This image may be time stamped. As the medical pill 306 is removed, it is taken by the patient, such as Fig.36 Subsequently, a post-dose image is captured by the user device 116, wherein the first marker 112 and the second marker 114 are in a common field of view of the camera of the user device 116, as shown in FIG. Fig.37 As shown. This image may also be timestamped. The application software may perform verification of the first marker 112 and the second marker 114, as discussed above. The application software may generate a data packet based on the timestamp and / or verification for transmission to the remote server.

[0089] It should be understood that in the case of pill bottle 200, first mark 112 and second mark 114 are static, where the same code is used to verify multiple doses. Due to its repeated use, this may allow forgery of dosing information. The availability of timestamps and remaining doses at remote locations provides some basis, and the legitimacy of the collected data can be verified by comparing with the expected dosing schedule. In addition, a second mark 114 can be set in each of these blisters 304. Therefore, in the case of having approached multiple blisters 304, multiple second marks 114 can be in the common view of the camera of the user device 116. Multiple second marks 114 can be hashed to create a hash chain as discussed above, providing a combination of the same code. Alternatively, the second mark 114 can be changed individually so that each blister 304 has a unique second mark associated with it. The second mark 114 can be changed to have a data bit or string other than a public unique number, where the public unique number can be used with an arithmetic operation to verify the first mark 112. The data bit or string can use serialized characters to count individual doses. It should be noted that the software application may prompt the user to cover, remove, or otherwise obscure older revealed second markers 114 so that only the most recent second markers 114 are displayed in the common field of view of the camera of the user device 116 . system

[0090] Reference Fig.38, the drug delivery device formed according to the present invention can be used as part of the system 400. The system 400 may include interaction with a manufacturing facility 402, where the drug delivery device is manufactured and / or in whole or in part. As discussed above, the first mark 112 and / or the second mark 114 (and any other hidden, to be revealed marks) can be applied to the drug delivery device at the facility 402. The components can be provided to the facility 402 with pre-marks (optically read during assembly) and / or marked at the facility 402. The control server 404 can control the generation of the creation of the first mark 112 and the second mark 114 based on the selected one or more algorithmic operations. The one or more algorithmic operations can be static (unchanged for all components), wherein the application software 406 is programmed with the selected one or more algorithmic operations. The control server 404 has a non-transitory memory 408 and / or a database 410 associated therewith, on which the association between the first mark 112, the second mark 114, the selected one or more algorithmic operations, and any other used marks can be stored. The association may be saved against details of the drug delivery device such as product number, batch number, assembly date, drug details (type(s), concentration(s)) and drug expiry date. The association may also include a unique number generated for any marking.

[0091] Although referenced as a single, control server 404 may be a series of distributed computer processing units located in the same location or remotely. The computer processing units may be connected via a local area network (LAN), a wide area network (WAN), and / or via the Internet. Similarly, memory 408 and database 410 (although referenced as a single) may be distributed over a series of linked memories and / or databases.

[0092] The application software 406 is configured to be downloaded from a portal, controlled by a user of the system 400, and / or downloaded from an application software market (such as Google Play or Apple App Store). The application software 406 can be configured to reside on the user device 116, with the ability to call a remote server to retrieve information (e.g., an API call). The application software 406 can also be configured to transmit the collected data (e.g., wirelessly) to the control server 404 and / or the secondary server 412 for review and analysis of the collected data. The control server 404 and / or the secondary server 412 can be operated or accessed by one or more of the following (subject to privacy laws and regulations): a manufacturer of a drug delivery device, a drug manufacturer, a healthcare provider, a medical insurance provider, and / or a compliance organization.

Claims

1. A medical syringe comprising: ontology; a drug reservoir contained within or defined by the body, the drug reservoir being configured to contain a supply of a drug; Intubation; a movable plunger for urging drug from the drug reservoir through the cannula; a first optically readable code on the body; and, a second optically readable code on the plunger, wherein an open window is formed in the body, wherein the plunger is initially in a first state wherein the second optically readable code is not aligned with the open window, and, wherein the plunger moves from the first state to a second state to advance drug from the drug reservoir through the cannula, and wherein, with the plunger in the second state, the second optically readable code is aligned with the open window so as to be viewable through the open window.

2. The medical syringe according to claim 1, wherein: The body extends elongated along a longitudinal axis, and the first optically readable code and the second optically readable code are positioned along the longitudinal axis.

3. The medical syringe according to claim 1, further comprising a needle shield formed to cover the cannula, a third optically readable code being located on the needle shield, wherein The third optically readable code is located on the needle shield so as to be covered by the body when the plunger moves from the first state to the second state, and wherein the needle shield is configured to extend from the body to cover the cannula in a fully extended state, and when the needle shield is in the fully extended state, the third optically readable code is exposed.

4. The medical syringe according to claim 1, wherein: A transparent or semi-transparent lens is located in the open window.

5. The medical syringe according to claim 1, wherein: The first optically readable code and the second optically readable code are positioned so as to be viewable in a common field of view of a camera of a smartphone.

6. The medical syringe according to claim 1, wherein: The body around the first optically readable code is a contrasting color to the plunger around the second optically readable code.

7. The medical syringe according to claim 1, wherein: First data is encoded within the first optically readable code to represent at least one of: the drug; the strength of the drug; the manufacturing batch number; the time the drug was manufactured; the date the drug was manufactured; the time the medical syringe was assembled; the date the medical syringe was assembled; the expiration date of the drug; and a unique number.

8. The medical syringe according to claim 1, wherein: A first number is encoded within the first optically readable code and a second number is encoded within the second optically readable code, and wherein the second number is algorithmically related to the first number.

9. The medical syringe according to claim 1, wherein: The drug reservoir is in the form of an ampoule having a transparent or translucent side wall.

10. A medical pill bottle comprising: a reservoir having a base defined by an upstanding sidewall, the base and the sidewall enclosing an interior volume for containing a supply of medical boluses, the sidewall terminating in a free end defining an access port in communication with the interior volume to provide access thereto; a cap mounted to a side wall of the reservoir across the opening, the cap being displaceable between an open state allowing access to an interior volume of the reservoir and a closed state completely covering the opening; a first optically readable code located on an exterior portion of the reservoir; and, a second optically readable code located on the cap so as to be covered by the cap when the cap is in the closed state and exposed when the cap is in the open state, Wherein the first optically readable code and the second optically readable code are positioned to be viewable in a common field of view of a camera of the smartphone.

11. The medical pill bottle according to claim 10, wherein: The cap includes a first portion mounted to a side wall of the reservoir and a second portion movable relative to the first portion to shift between the open state and the closed state, and wherein the second optically readable code is located on a lower surface of the second portion.

12. The medical pill bottle according to claim 11, wherein: The second portion is hingedly connected to the first portion.

13. The medical pill bottle according to claim 10, wherein: First data is encoded within the first optically readable code to represent at least one of: the drug; the strength of the drug; the manufacturing batch number; the time the drug was manufactured; the date the drug was manufactured; the time the medical syringe was assembled; the date the medical syringe was assembled; the expiration date of the drug; and a unique number.

14. The medical pill bottle according to claim 10, wherein: A first number is encoded within the first optically readable code and a second number is encoded within the second optically readable code, and wherein the second number is algorithmically related to the first number.

15. A medical pill blister package comprising: a plastic layer having an array of blisters formed therein, each blister being formed to contain at least one medical pill; a foil layer secured to the plastic layer to cover the blister; a first optically readable code on the foil layer, the first optically readable code being positioned out of alignment with the blister; and, a secondary optically readable code located within each of said blisters, wherein upon approaching a first one of the blisters, the corresponding secondary optically readable code is exposed, and the exposed secondary optically readable code and the first optically readable code are positioned to be viewable in a common field of view of a camera of a smartphone.

16. The medical pill blister package according to claim 15, wherein: For each of the blisters, a unique secondary optically readable code is provided.

17. A method for preparing a medical syringe for use in monitoring the administration of a drug to a patient, the method comprising: preparing a first optically readable code; preparing a second optically readable code; preparing a medical syringe having a body, a drug reservoir contained within or defined by the body, a cannula, and a movable plunger for urging the drug from the drug reservoir through the cannula, the drug reservoir containing a drug supply, wherein an open window is formed in the body, and wherein the second optically readable code is applied to the plunger during preparation of the medical syringe, wherein the plunger is initially set to a first state in which the second optically readable code is not aligned with the open window; and, The first optically readable code is applied to the body.

18. The method according to claim 17, wherein: First data is encoded within the first optically readable code to represent at least one of: the drug; the strength of the drug; the manufacturing batch number; the time the drug was manufactured; the date the drug was manufactured; the time the medical syringe was assembled; the date the medical syringe was assembled; the expiration date of the drug; and a unique number.

19. The method according to claim 17, wherein: A first number is encoded within the first optically readable code and a second number is encoded within the second optically readable code, the second number being algorithmically related to the first number.

20. The method according to claim 19, wherein: The second number is algorithmically related to the first number by one or more mathematical operations.

21. The method according to claim 20, wherein: The one or more mathematical operations can include at least one selected from: adding a predetermined value; subtracting a predetermined value; multiplying by a predetermined value; and dividing by a predetermined value.

22. The method of claim 19, further comprising providing a downloadable application for use on a camera-equipped, internet-enabled device at the point of use of the medical injector, wherein The first optically readable code and the second optically readable code are readable by a camera of the device having the application software, the application software being configured to: perform one or more algorithmic operations thereby allowing the application software to determine an intermediate code based on one of the first optically readable code and the second optically readable code; and ii, comparing the intermediate code against the other of the first optically readable code and the second optically readable code for verification.

23. The method of claim 19, further comprising providing a downloadable application for use on a camera-equipped, internet-enabled device at the point of use of the medical injector, wherein The first optically readable code and the second optically readable code are readable by a camera of the device, wherein at least one of the first optically readable code and the second optically readable code comprises encoded data bits or data strings representing one or more arithmetic operations, and wherein the application software is configured to determine the one or more arithmetic operations based on the data bits or data strings.

24. The method according to claim 23, wherein: The application software is configured to call a remote database to look up the one or more arithmetic operations based on the data bits or data strings.

25. The method according to claim 23, wherein: The application software is associated with a lookup table that cross-references the data bits or data strings against the one or more algorithmic operations.

26. The method of claim 17, wherein: The plunger is movable from the first state to a second state to advance drug from the drug reservoir through the cannula, and wherein, with the plunger in the second state, the second optically readable code is aligned with the open window so as to be viewable through the open window.

27. The method of claim 17, wherein: The medical injector is selected from the group consisting of a pen injector, a syringe, and a body wearable injector.

28. A medical syringe comprising: ontology; a drug reservoir contained within or defined by the body, the drug reservoir being configured to contain a supply of a drug; Intubation; a movable plunger for advancing drug from the drug reservoir through the cannula; and, an optically readable code on said plunger, wherein an open window is formed in the body, wherein the plunger is initially in a first state wherein the optically readable code is not aligned with the open window, and, wherein the plunger moves from the first state to a second state to advance drug from the drug reservoir through the cannula, and wherein, with the plunger in the second state, the optically readable code is aligned with the open window so as to be viewable through the open window.

29. The medical syringe of claim 28, wherein: The medical injector is selected from the group consisting of a pen injector, a syringe, and a body wearable injector.

30. The medical syringe of claim 29, wherein: In case the medical injector is a body wearable injector, the body is box-shaped having a base face having an adhesive layer associated therewith and an outer face facing in a direction opposite to the base face.

31. The medical syringe of claim 30, wherein: The open window is formed in the base face.

32. The medical syringe of claim 31, wherein: A second optically readable code is located on the adhesive layer or in a discrete portion formed in the adhesive layer.

33. The medical syringe of claim 30, wherein: The open window is formed in the exterior face.

34. A system for monitoring administration of a drug to a patient, the system comprising: The medical syringe according to any one of claims 1 to 9; as well as, A camera-equipped, internet-enabled device having application software stored thereon, wherein the camera of the device is configured to read the first optically readable code and the second optically readable code, wherein the application software is configured to: i, perform one or more algorithmic operations to determine an intermediate code based on one of the first optically readable code and the second optically readable code; and ii, compare the intermediate code against the other of the first optically readable code and the second optically readable code for verification.

35. The system of claim 34, wherein: First data is encoded within the first optically readable code to represent at least one of: the drug; the strength of the drug; the manufacturing batch number; the time the drug was manufactured; the date the drug was manufactured; the time the medical syringe was assembled; the date the medical syringe was assembled; the expiration date of the drug; and a unique number.

36. The system of claim 34, wherein: A first number is encoded within the first optically readable code and a second number is encoded within the second optically readable code, the second number being algorithmically related to the first number.

37. The system of claim 34, wherein: The second number is algorithmically related to the first number by one or more mathematical operations.

38. The system of claim 37, wherein: The one or more mathematical operations can include at least one selected from: adding a predetermined value; subtracting a predetermined value; multiplying by a predetermined value; and dividing by a predetermined value.

39. The system of claim 34, wherein: At least one of the first optically readable code and the second optically readable code includes encoded data bits or data strings representing the one or more arithmetic operations, and wherein the application software is configured to determine the one or more arithmetic operations based on the data bits or data strings.

40. The system of claim 39, wherein: The application software is configured to call a remote database to look up the one or more arithmetic operations based on the data bits or data strings.

41. The system of claim 39, wherein: The application software is associated with a lookup table that cross-references the data bits or data strings against the one or more algorithmic operations.

42. A body-wearable injector comprising: ontology; a drug reservoir contained within the body, the drug reservoir configured to contain a supply of a drug; Intubation; a movable plunger for advancing drug from the drug reservoir through the cannula; an open window in the body, wherein an optically readable code located within the body is aligned with the open window; and, a shielding panel, wherein the shielding panel can be adjusted from an initial state to a second state, Wherein, the shielding panel covers the open window in the initial state to shield the optically readable code, and The shielding panel does not cover the open window in the second state, thereby allowing the optically readable code to be viewed through the open window.

43. The body wearable injector of claim 42, wherein: The body is box-shaped having a base face having an adhesive layer associated therewith and an exterior face facing in a direction opposite to the base face.

44. The body wearable injector of claim 43, wherein: The open window is formed in the base face.

45. The body wearable injector of claim 44, wherein: A second optically readable code is located on the adhesive layer or in a discrete portion formed in the adhesive layer.

46. ​​The body wearable injector of claim 43, wherein: The open window is formed in the exterior face.

47. The body wearable injector of claim 42, wherein: A second optically readable code is located on the obscuring panel and is viewable through the open window when the obscuring panel is in the initial state.

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