Abstract
Ingestible product and medical device containers validate self-administration of the product and/or corresponding use of the device over a schedule. A machine-readable optical code label such as a QR Code is affixed to an interior surface of a container containing the product or device. The container must be open to electronically read the optical code label. The label contains data associated with the product or device is read by a software application installed on a smartphone. The software receives the label-embedded data and a timestamp to validate the patient is self-administering the medication or device consistent with a schedule.
Claims
1. A method for electronically tracking ingestible product consumption over a series of timed dosages, the method comprising: affixing, inserting or imprinting onto the interior of a product container a machine-readable optical code encoding an identifier unique to that individual container, the container enclosing an ingestible product wherein the optical code is only readable when the container is open and the product accessible; establishing a schedule of timed dosages for the product in a software application operable on a portable, network-connected electronic device; decoding the machine-readable optical code through a camera in the device to resolve the machine-readable optical code back to the identifier; registering a data association between the identifier and the schedule of timed dosages; subsequently, scanning the machine-readable optical code upon administration of a scheduled dose by the device to decode the identifier from the machine-readable optical code; automatically resolving both the product administered and schedule of timed dosages for that product from the prior damage association with the identifier; storing a record of the scheduled dose timestamp whereby the software application updates a database for the schedule of timed dosages with the timestamp of the last scan of the machine-readable optical code decoded to the identifier; establishing a database query that returns records for the schedule of doses when in an overdue state; polling the database query to retrieve records for one or more overdue doses; and firing a notification event to alert one or more recipients of the overdue state whereby the one or more recipients are notified to administer the dose of product.
2. The method of claim 1 wherein the value of the identifier is stored in a licensing data store.
3. The method of claim 1 further comprising the steps of storing the identifier in a licensing data store and authorizing, through the software application, only a licensed identifier for the data association whereby an unauthorized identifier renders use of the software application fully or partially inoperable.
4. The method of claim 1 further comprising the steps of: initializing a quantity of doses upon the registering of the data association between the identifier and the schedule of timed dosages; decrementing the quantity of doses upon each subsequent scan of the machine-readable optical code; calculating the total remaining doses; and displaying on the device the total remaining doses.
5. The method of claim 4 further comprising the step of calculating the remaining time left on the schedule of timed dosages based on the total remaining doses and displaying on the device the total remaining time left taking the product according to the schedule of timed dosages.
6. The method of claim 4 further comprising the step of setting a threshold for refilling or reordering additional doses based on the total remaining doses and automatically transmitting a purchase order to refile or reorder additional doses upon meeting the threshold.
7. A method for electronically tracking ingestible product consumption over a series of timed dosages, the method comprising: affixing, inserting or imprinting onto the interior of a product container a machine-readable optical code encoding an identifier unique to that individual container, the container enclosing an ingestible product wherein the optical code is only readable when the container is open and the product accessible; establishing a schedule of timed dosages for the product in a software application operable on a portable, network-connected electronic device; decoding the machine-readable optical code through a camera in the device to resolve the machine-readable optical code back to the identifier; registering a data association between the identifier and the schedule of timed dosages; subsequently, scanning the machine-readable optical code upon administration of a scheduled dose by the device to decode the identifier from the machine-readable optical code; automatically resolving both the product administered and schedule of timed dosages for that product from the prior damage association with the identifier; storing a record of the scheduled dose timestamp whereby the software application updates a database for the schedule of timed dosages with the timestamp of the last scan of the machine-readable optical code decoded to the identifier; initializing a quantity of doses upon the registering of the data association between the identifier and the schedule of timed dosages; decrementing the quantity of doses upon each subsequent scan of the machine-readable optical code; calculating the total remaining doses; displaying on the device the total remaining doses, calculating the remaining time left on the schedule of timed dosages based on the total remaining doses and displaying on the device the total remaining time left taking the product according to the schedule of timed dosages; establishing a database query that returns records for the schedule of doses when in an overdue state; polling the database query to retrieve records for one or more overdue doses; and firing a notification event to alert one or more recipients of the overdue state whereby the one or more recipients are notified to administer the dose of product.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
(1) For a fuller understanding of the invention, reference should be made to the following detailed description, taken in connection with the accompanying drawings, in which:
(2) FIG. 1 is an elevated, perspective view of the general application of the invention showing a machine-readable code imprinted to the inside of a medication container cap.
(3) FIG. 2 is a diagrammatic view of an embodiment of the invention generating unique identification codes for individual cap labels.
(4) FIG. 3 is a diagrammatic view of an embodiment of the invention showing adhesive labels affixed to the inside of a medication container cap.
(5) FIG. 4 is a mobile device user interface (UI) adding a new medication for a user.
(6) FIG. 5 is a mobile device UI adding a new medication dosage schedule.
(7) FIG. 6 is a mobile device UI scanning a machine-readable code affixed to the interior of a medication bottle cap to link the code with a dosage schedule.
(8) FIG. 7 is a mobile device UI showing confirmation that a machine-readable code identifier is linked to a dosage schedule.
(9) FIG. 8 is a mobile device UI showing the scanning of a machine-readable code affixed to the interior of a medication bottle cap representing the administration of a dose.
(10) FIG. 9 is a mobile device UI showing confirmation that a machine-readable code identifier was decoded and the dosage schedule updated to reflect the consumption of a dose.
(11) FIG. 10 is a mobile device UI showing expanded details of a dosage schedule in-progress.
(12) FIG. 11 is a diagrammatic view of a database schema according to an embodiment of the invention.
(13) FIG. 12 is a diagrammatic view of an embodiment of the invention for over-the-counter products.
(14) FIG. 13 is an elevated, isometric view of a blister pack medication container according to an embodiment of the invention.
(15) FIG. 14 is a partially diagrammatic view of an embodiment of the invention showing a master code for a blister pack with serialized child codes for each individual dose.
(16) FIG. 15 is a mobile device UI showing an automatic reordering or refilling option when dose quantity falls below a threshold.
(17) FIG. 16 is a diagrammatic view of the prior art against the present invention that generates an adherence pattern based on container openings.
(18) FIG. 17 is a diagrammatic view of an embodiment of the invention showing over-the-counter production consumption tracking in a multi-user environment.
(19) FIG. 18 is a front, elevated isometric view of an orthodontic appliance case embodiment of the invention.
(20) FIG. 19 shows three individual medication pouches connected by a perforated seal having partially occluded scannable QR-codes for dosing adherence confirmation.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
(21) Turning now to FIG. 1, a medication container 10 has bottom 80, outer label 60, mouth 70 and cap 50. Cap has an interior surface upon which a machine-readable code 20 is affixed and is otherwise occluded from view when cap 50 is secured to mouth 70. The term medication is intended to include supplements, vitamins, over-the-counter medication, and prescribed medications that are scheduled over a plurality of doses. In FIG. 1, medication 90 is shown as tablets but other forms such as capsules, gummies and the like are equally functional. As disclosed in U.S. Pat. No. 10,825,559 from which this application ultimately claims priority and whose specification is incorporated herein by reference, decoding machine-readable code requires the user to remove cap 50 from container 10. Hence, when the machine-readable code is processed by a smartphone application, the contents of bottle 10 are accessible to the patient. This improves medication adherence and optimization over the prior art by establishing inherent accessibility to the medication.
(22) FIG. 2 shows an embodiment of the invention directed at high-volume deployment of containers using the interior-affixed machine-readable codes. A globally unique identifier (GUID) is a 128-bit number used to identify data in computer systems. When generated according to standards, GUIDs are, for most practical purposes, entirely unique. Their uniqueness does not rely on a central registration authority or cooperation between multiple parties creating them, unlike most other numbering schemes. While the probability that a GUID will be duplicated is not zero, it is close enough to zero to be negligible. A widely accepted standard for GUIDs is the Internet Engineering Task Force (IETF) Standards-Track RFC 4122. In its canonical string representation, the 16 octets of a GUID are represented as 32 hexadecimal (base-16) digits. These are displayed in five groups separated by four hyphens, for a total of 36 characters (32 hexadecimal characters and 4 hyphens). Turning back to FIG. 2, a GUID generator 100 produces GUID array 105 of twenty-four (24) GUID strings. These are sent to a QR-code encoder 110 which produces a 4×6 grid of unique QR-codes on ¾.sup.th inch AVERY-brand 5408-format circular labels. These labels may be affixed to the interior of container cap 50. When GUIDs are deployed, an embodiment of the invention also sends the 36-character strings to licensing database 120. This provides a verification in approved applications that the GUID code is not used for infringing or otherwise rogue purposes.
(23) An advantage of generating unique QR-codes is that no confidential patient or medication information is present. The unique QR-code is completely agnostic as to the medication, supplement, vitamin or any other multi-dose product in the container. The data relating to dosage, schedule and adherence is maintained in or through the software application that reads and decodes the QR-code.
(24) Yet another advantage of generating unique QR-codes is that large inventories of containers may be maintained without concern they must be associated with a particular patient or medication. The use of adhesive labels is only one embodiment. Additional embodiments include high-volume imprinting, etching or the like of the codes through mass-production. A pharmacist need not manually print an individual QR-code label for a prescription. Rather, they pull a pre-printed cap off-the-shelf and simply link the unique identifier to the prescription that is filled. Alternatively, the pharmacist may leave it to the patient to link the prescription to the QR-code upon taking the first dose.
(25) Yet another advantage of the unique QR-codes is transferability. For example, if a patient is traveling, they might only want to travel with a small amount of medication. A smaller container with its own unique QR-code holds the “travel” doses and the user temporarily associates that unique QR-code with the dosage schedule. When the traveler returns home, they reassociate the dosage schedule with the original medication container QR-code for seamless medication adherence.
(26) FIG. 3 shows the detachment of an individual adhesive label containing a QR-code 20 and affixing it to the interior surface of a container cap 50. All the QR-codes on label sheet 115 are unique GUIDs verifiable through any decoding application.
(27) FIGS. 4-10 demonstrate an embodiment of the invention through a smartphone UI. In FIG. 4, UI 130 receives a new medication string value 150 which it adds to medication list 140. In the example, the string value is “Vitamin C” The string 150 is inserted into a medications table which returns the primary key of the inserted row returned by SCOPE_IDENTITY( ) from MICROSOFT SQL SERVER. In FIG. 5, the primary key is used to select the just-inserted string in dropdown list 160. FIG. 5 accepts data to schedule dosages. This includes the quantity of units per each dose 170 (e.g., 1 or 2 tablets); the frequency 180 (e.g., “Once a Day”); and the total quantity of units 190 (e.g., 60 pills). A “save” control 200 sends the data to a database and returns get another SCOPE_IDENTITY( ) value for the primary key for the just-inserted row in a schedule table. This primary key is then passed onto a scan function shown in FIG. 6.
(28) Scanning window 210 opens rear-facing camera on the device for the registration process. To help position the camera, a partially opaque window is overlaid on window 210 to help center the camera to the interior face of container cap 50 displaying the QR-code. The registration process in FIG. 6 links the decoded QR-code with the schedule for dosages. This is only necessary once. In FIG. 7, a confirmation 220 is displayed showing the QR-code was linked successfully to the schedule of dosages. Existing schedules for Iodine 230, Creatine 240 and Vitamin D 250 are displayed with countdown values 260 to the next scheduled dose. When the QR-code now linked with the Vitamin C schedule is scanned against in FIG. 8, a confirmation is shown in FIG. 9 that the dose was recorded. The Vitamin C schedule 280 is now shown in the list of schedules and the next dose is noted to be taken in 24 hours (e.g., once-a-day). The button 280 for the Vitamin C schedule activates an accordion control in FIG. 10 to display additional details 290. It should be noted that each time the associated QR-code for the Vitamin C container is scanned, the total quantity left is decremented by one (e.g., 60−1=59).
(29) FIG. 11 shows a database schema according to an embodiment of the invention. Using MICROSOFT IDENTITY SERVICES, a user table 300 stores the application users. Medication table 310 links users to medications. Medications are incorporated into scripts table 320 which stores dosage schedules. When QR-codes are processed, the data is updated in medLog table 330. SQL queries are polled for dosage reminders which are transmitted by text messaging, email and/or push notifications to the mobile application.
(30) FIG. 12 shows an embodiment of the invention for OTC products. Container 340 for Vitamin D3 is secured by cap 350. Interior surface of cap 350 includes QR-code 360 holding a JavaScript Object Notation (JSON) formatted string 370 containing dosage information for the Vitamin D3 product. This includes its brand-name, universal product code (UPC), dose amount, dose frequency and the total units contained in container 340. This JSON is decoded and the values assigned as parameters in a SQL stored procedure to insert the schedule and medication automatically as shown in UI 380 wherein the brand name is populated as the medication 290, the dose amount in field 400, the frequency in field 410 and the total unit quantity in field 420.
(31) FIG. 13 shows an embodiment of the invention showing a blister pack container 420 having compartments 440 for six tablets. In the embodiment shown QR-code 430 is visible when the tablet is removed. In most blister packs, the tablet is punched through a back foil seal. In such circumstances, the boundaries of the QR-code are reinforced to avoid tearing and damaging the scan integrity of the QR-code graphic. An alternative embodiment is accessing the tablet from the clear encasing through the front of the blister pack so the back foil seal is never broken. In all embodiments, the medication or packaging occludes the scanability of the QR-code while the medication is inaccessible to the patient. However, then the packaging is changed to an open state where one or more doses are accessible to the patient, then the QR-code is scannable and the dose registered in the medication log table.
(32) FIG. 14 shows another blister pack embodiment with additional detail. Here, box 530 holds one or more blister packs 420 which, in turn, contain individual doses 440 of medication. It is anticipated by this invention that individual doses may include one or a plurality of units of medication provided they are scheduled similarly. A master GUID 510 is encoded into a QR-code 500 which is registered with the software application according to a schedule of dosing. From the master GUID 510, the individual doses are serialized 520 and appended onto the master GUID 510 value. Each serialized 520 value is associated with each individual dose within the blister pack 420. In the embodiment shown, code backing 540 is affixed to the back of the blister pack 420 wherein the QR-code 430 is occluded from scanning by the presence of medication 440 in its initial state. In this embodiment, tab 490 is pulled away from the back plane of blister pack 420 revealing the QR-code 430 imprinted on a backing segment 470 aligned to dose segment 480. Horizontal perforations 460 and vertical perforations 450 on code backing 540 align with perforations on blister pack 420 so that only the backing segment with the individual QR-code for a single dose is exposed at one time.
(33) Preferably, once scanned, the backing segment 470 of the scanned QR-code is detached and discarded after the associated dose is consumed. The serialization of each individual dose within the master QR-code provides an enhanced level of oversight and adherence as the doses may be inadvertently taken out of order but nevertheless marked as administered by the software application. Furthermore, individual doses may be detached for travel or other purposes but still carry the scannable QR-code specific to that particular dose. Another advantage of this system is in the case of a bolus dose wherein the start of a course of medication may initially call for a higher initial dose. Therefore, the doses in this embodiment may be asymmetrical with the remaining doses but the adherence to the dose schedule is nevertheless maintained.
(34) FIG. 15 shows an embodiment of the invention having an automatic reordering option 550. For example, for a chronic condition prescription, refills previously were scheduled based on perfect compliance with every scheduled dose. However, under the present invention, the quantity of the remaining doses is decremented upon each scan (e.g., associated administration). Accordingly, refills of prescription medications are automatically implemented only when the patient runs low on the medication. An advantage of this is to reduce the “stockpiling” of unused medication which is dangerous and wasteful. A similar implementation exists for vitamins and supplements such as those sold through AMAZON. If a user wants to maintain adherence to a schedule of Vitamin D3 the application detects when they are low and sends an API request out to AMAZON retailer services to reorder before their current doses are exhausted. This benefits the user in improved adherence to a schedule and improves the experience for the retailer by reducing friction in the reordering process.
(35) FIG. 16 shows a comparison of low-cost, prior art technologies 560 which seek to track the progress of dose administration from t.sub.0 through t.sub.10. Cost efficient technologies rely on user reporting of dose administration. For software-based systems such as those running on mobile devices, this consists of a scheduled reminder and subsequent user confirmation that a dose was administered. However, there is nothing to verify the user was even in proximity of the medication upon user confirmation. It is common that users may falsely acknowledge a dose was taken with the good intention of taking it promptly. However, intervening distractions lead to a false confirmation of administration. This results in both non-adherence and inevitable stockpiling of the medication with surplus doses. Scanning a code on the label container can establish that the user was in proximity to the medication but users can “rapid” scan all their medications to feign adherence without taking the medication. Some users might have difficulty opening the medication container but can nevertheless false claim a dose was administered, sometimes out of embarrassment. The present invention 570 can establish an adherence pattern which is recorded and monitored 580. At each timed-dose interval, the code to establish the dose is occluded from scanning by closure of the container. It is only when the container is open and the medication accessible can the code be registered, and the adherence pattern maintained. Medication adherence under the prior art teachings is, by comparison, speculative. The present invention requires the medication be made accessible. For a user to feign a dose administration under the claimed invention, they would have to go to the medication, open the container, scan the interior of the container cap but (while the medication is fully accessible) decline to take the dose.
(36) FIG. 17 shows an embodiment of the invention for over-the-counter products that are shared within a household. In this example, a container 340 of Vitamin D3 has a 90-unit quantity. Two string values are appended to generate a combination code 630 on the interior surface of the container cap 350. A first GUID or serialization code 610 is unique to each cap manufactured and labeled. A second product code 620 is associated with retail universal product code (UPC) of the product and the associated directions for use. Users 650, 660 and 670 all share access to the Vitamin D3 product. Upon each dose, the cap is scanned and a master record (stored in API database 680) updates the quantity of the shared container. As shared container remaining quantity reaches a threshold value 690, an automatic reorder 700 event is fired to automatically purchase another container 340. This embodiment of the invention may simply be for inventorying and reordering so the product is continuously available or may also be combined so that adherence to the product is available in a multi-user environment without segregating the product into individual containers.
(37) FIG. 18 shows an embodiment of the invention for medical devices that are deployed on a schedule and stored in a container in the interim. In the example shown, orthodontic retainers 730 are stored in retainer case 740 which opens and closes in a clamshell manner. Top portion 710 of retainer case 740, while in an open position, exposes QR-code 720. According to an embodiment of the invention, the retainer case 740 is opened, the QR-code 720 scanned and the retainers 730 deployed overnight. By scanning the QR-code 720 adherence to the nightly use of retainers 730 is monitored and verified. This may be applied to any medical device used according to a schedule and stored in a container that occludes the machine-readable code from scanning while in a closed state.
(38) FIG. 19 shows an embodiment of the invention for individual medication pouches 750a-c. QR-code labels 760a-c are affixed into the interior 780a-c of each respective pouch wherein the plastic forming pouches 750a-c is partially opaque. A patient can see medication 770a-c exists in each pouch through the opaque frosting of the plastic but the level of opacity prevents the scanning of interiorly affixed QR-codes 760a-c from the exterior of the unopened pouch. Only until each individual pouch is opened to consumer medication 770a-c can the QR-code be read by a scanning device. In an alternate embodiment of the invention, QR-codes 760a-c are imprinted on in the inside of a bi-fold paper inserted into the interior 780a-c of each pouch 750a-c wherein the bi-fold must be removed and opened to expose the QR-code for scanning upon each dose.
Glossary of Claim Terms
(39) Administration means the act of consuming a product dosage according to a schedule.
(40) Barcode means a machine-readable optical label that contains information about the item to which it is attached.
(41) Camera means an electronic device component capable of optically scanning a machine-readable code.
(42) Cap means the top enclosure of a container which may be partially or fully removable from the container.
(43) Data association means linking one record to another. For example, updating a column value in a schedule of dosages with a GUID string obtained from decoding a machine-readable code.
(44) Dosage means the rate of application of a quantity of medicine or consumable product.
(45) Globally unique identifier (GUID) means a string of characters randomly generated of sufficient length to be substantially unique without coordination with a central issuing authority.
(46) Licensing Data Store means a database for inserting and querying authorized GUID values allowed to operate with a licensed software application according to the invention.
(47) Medication means a drug used to diagnose, cure, treat, or prevent disease including supplements and vitamins
(48) Notification Event means a trigger to send user-detectable output such as a push command to vibrate a smartphone; a push notification to play a sound on a smartphone; a push notification to display a visual alert on a smartphone; a text messaging transmission to a smartphone; an email transmission to a smartphone; and/or an automated voice call to a smartphone.
(49) Optical Code means a representation of data in a visual, machine-readable form.
(50) Patient means a recipient of health care services.
(51) Portable Electronic Device means a mobile device having a screen, camera function and wireless network connectivity.
(52) Prescription (Rx) means a health-care regiment implemented by a physician or other qualified health care practitioner in the form of instructions that govern the plan of care for an individual patient. For this patent specification, the term refers to a course of a prescription drug typically dispensed from a pharmacist.
(53) QR Code (Quick Response Code) is a trademark of Denso Wave Incorporated for a type of matrix barcode. A QR code consists of black squares arranged in a square grid on a white background, which can be read by an imaging device such as a camera and processed using Reed-Solomon error correction until the image can be appropriately interpreted. The required data is then extracted from patterns that are present in both horizontal and vertical components of the image.
(54) Software Application means software running on top of the operating system of a portable electronic device.
(55) Structured Data means any data that resides in a fixed field within a record or file.
(56) Structured data has the advantage of being easily entered, stored, queried and analyzed.
(57) Timestamp means a sequence of characters or encoded information identifying when a certain event occurred, including the date and time of day.
(58) Uniform Resource Identifier (URI) means a string of characters that unambiguously identifies a particular resource, typically on the Internet.
(59) Universal Dosing Schedule means directions provided by over-the-counter products and medications that apply to most consumers of the product.
(60) The advantages set forth above, and those made apparent from the foregoing description, are efficiently attained. Since certain changes may be made in the above construction without departing from the scope of the invention, it is intended that all matters contained in the foregoing description or shown in the accompanying drawings shall be interpreted as illustrative and not in a limiting sense.
