Dose tracking device

Abstract

Disclosed are embodiments of dose tracking devices configured for use with commercially available drug packaging or “blister cards.” The disclosed tracking devices track the removal of drug doses from the “blister cards” with which they interact. A particular disclosed embodiment relates to an electronic tracking module comprising multiple voltage sensors electrically coupled to a circuit trace attached to a drug blister card, which may be commercially available or provided by a healthcare provider. The circuit trace comprises multiple circuits that align with a drug blister containing drug doses. When a dose is removed from the blister, the circuit corresponding to the circuit trace is disconnected, indicating that the dose has been removed. Patient medication information can be transmitted to a remote server for monitoring and data storage.

Description

Technical Field

[0001] Cross - reference to related applications

[0002] This application claims the benefit of the filing dates of U.S. Provisional Application No. 63 / 514,459, filed Jul. 19, 2023, and U.S. Provisional Application No. 63 / 498,436, filed Apr. 26, 2023, each of which is hereby incorporated by reference in its entirety.

[0003] The present disclosure relates to a dosing tracking device that can be used in combination with a commercially available pharmaceutical blister card to record when a dose is removed from the card.

Background Art

[0004] Pharmacists, caregivers, and insurers are interested in ensuring that patients appropriately follow a medication regimen. This is particularly true for very expensive medications and / or treatments where non - compliance with dosing protocols can have substantial harmful effects. For example, certain medications such as hepatitis C drugs must be taken at specific doses at specific times. Therapeutic effectiveness depends on patient compliance with dosing instructions. Non - compliance with dosing instructions can have substantial harmful effects for an individual, including worsening the patient's condition, in contrast to improving or alleviating symptoms associated with a particular disease.

[0005] Clinical trials provide another example where patient compliance with clinical trial dosing instructions is absolutely necessary to obtain reliable dosing and effectiveness data. If patients do not follow the clinical trial medication regimen, data can be substantially lost and the cost of the clinical trial can increase.

[0006] Conventional known devices typically require the user to do something other than take the required dose, such as recording that the dose has been taken and potentially the time the dose was taken. For example, certain smartphone applications are available that allow users to keep a record of taking a specific dose. [Overview of the Initiative] [Problems that the invention aims to solve]

[0007] This specification discloses dose tracking devices configured for use with commercially available packaging or “blister cards” for lozenges, therapeutic drugs, tablets, or other dosages, collectively referred to herein as “drugs.” The disclosed tracking devices can track the removal of drug doses from the “blister cards” with which they work. One feature of certain disclosed embodiments is that the tracking devices eliminate the need for the user to input or record events.

[0008] Certain aspects of this disclosure relate to an electronic tracking module comprising multiple voltage sensors electrically coupled to a circuit trace attached to a drug blister card, which may be commercially available or provided by a healthcare provider. While blister cards of various dimensions and numbers of drugs may be available, the blister card is most typically a 4x8 tablet blister card. The circuit trace comprises multiple circuits that align with a drug blister containing drug doses. When a dose is removed from the blister, the circuit corresponding to the circuit trace is disconnected. This reduces the total circuit voltage and increases the total circuit resistance, thereby indicating that the dose has been removed. Those skilled in the art will understand that the circuit voltage and resistance are correlated according to Ohm's law, by the equation E = I × R, or voltage = current × resistance. In certain aspects of this disclosure, the circuit trace comprises multiple conductive metal pads, such as silver pads, configured to provide electrical connections to the device. The circuit trace also comprises multiple semiconducting circuits. These semiconductive circuits can be applied using any appropriate technique, such as using a semiconductive ink, typically a carbon-based ink, or graphite ink as an example, to align with the blister on the drug blister card.

[0009] The device typically comprises multiple metal clamps that securely engage the device with a blister card. In certain embodiments of the present disclosure, the clamps flex upon insertion of the blister card and then return to an unflexed position to secure the device to the blister card. The clamps may be, for example, J-clamps that engage with clamp projections to lock the clamp and the blister card in place. The device may include additional features that facilitate secure engagement of the blister card with the device. For example, the device may have a blister card receiving slot sized to allow the blister card to be press-fitted into the device. This press-fitting can be facilitated by engaging with the inserted blister card, causing a slight pucker in the inserted blister card, thereby providing a shoulder that engages the card with the device under tension and secures the card to the device. The device may also have an external shelf on which at least a portion of the blister card rests to further prevent movement of the blister card relative to the device (certain embodiments of the present disclosure include a small shelf, such as a 1-5 mm protruding shelf).

[0010] Certain aspects of the present disclosure further include alignment protrusions that facilitate the alignment of the device with the blister pack and the circuit trace. These protrusions may be configured, for example, to align with the metal pads of the circuit trace.

[0011] In certain aspects of this disclosure, as the drug is removed from each blister, the total circuit voltage predictably decreases and the total circuit resistance increases. As a result, the number of drug doses remaining in the blisters on the blister card can be determined by correlating the circuit voltage or resistance with the number of blisters that have burst or not.

[0012] A dose tracking device typically comprises an electronic control board for controlling device functionality. The control board includes a plurality of electrical connectors for electrical connection to circuit traces. The plurality of electrical connectors may be any suitable connectors, such as spring-biased connectors, pin connectors, leaf spring connectors, or any combination thereof. The device may be a cellular connectivity device, and further may be a Bluetooth device, a WiFi device, or any combination thereof. In one aspect of the present disclosure, the device is configured to be used as a cellular connectivity device and for that purpose includes a suitable module, such as an NB-IoT module or a combination of an NB-IoT module and an LTE CAT-M1 module. NB-IoT networks are widely available in China and several EU markets, while LTE CAT-M1 networks are typically used in other major markets such as Canada, Japan, and the United States. The board may also include a microcontroller, a rechargeable power supply, a USB port for charging, and / or LEDs indicating on / off and / or charging status.

[0013] The device may be used in conjunction with a remote server to receive data from the device. The device may also include retry logic that attempts to connect to the blister card and / or periodically sends data to the remote server. The device may attempt to connect, for example, every 15 minutes. The device is configured to connect at least once every 24 hours.

[0014] Devices according to aspects of this disclosure can be fabricated using any suitable method, such as injection molding or 3D printing from polymer materials. The devices may consist of a single unit, a clamshell, or a device comprising separable components.

[0015] A dose tracking device disclosed in an aspect of the present disclosure, configured for use in conjunction with a commercially available drug blister card, comprises a receiving slot sized to press-fit onto a commercially available drug blister card inserted into the device, the device further comprising a shoulder that engages with the inserted blister card, causing a slight constriction in the inserted blister card, thereby causing the card to engage with the device under tension, and a shelf that contacts at least a portion of the blister card to further prevent movement of the blister card relative to the device. The device comprises a plurality of voltage sensors configured to electrically couple to a circuit trace attached to the drug blister when the card and circuit trace are inserted into the device. The circuit trace comprises a plurality of conductive metal pads configured to electrically connect to the device, and a plurality of semiconducting circuit traces that align with the blister on the drug blister card. Alignment projections facilitate the alignment of the device with the blister pack and circuit trace, and a plurality of metal clamps hold the blister card in place relative to the device. When a dose is ejected from the blister, the circuit corresponding to the circuit trace is disconnected, thereby reducing the total circuit voltage and increasing the total circuit resistance, indicating that the dose has been ejected. The control board controls the device functions and includes a microcontroller, a rechargeable power supply, a USB port, and / or LEDs that indicate on / off and / or charging status.

[0016] In aspects of this disclosure, an adhesive circuit trace is also disclosed, configured to be attached to a blister card and to make an electrical connection with a dose tracking device. The adhesive circuit trace may have a front side comprising a plurality of conductive metal pads for electrical coupling with the dose tracking device, and further comprising a plurality of circuits electrically coupled to the conductive metal pads. The plurality of circuits are configured to align with a blister on the blister card and to measure voltage or resistance across the individual circuits aligned with each drug blister. The circuit trace comprises a back side comprising an adhesive material and an adhesive cover sheet that can be removed to adhere the circuit trace to the drug blister card. In one aspect of this disclosure, the trace adhesive was an ethylene acrylic acid copolymer, such as ProHere E 00016 adhesive.

[0017] Methods are also disclosed that include using a dose tracking device, a combination of dose tracking devices, and / or circuit traces. The method may include providing a user with a dose tracking device along with instructions on inserting a drug blister card into the device to properly align the trace with an electrical sensor on the device. The user inserts a drug blister card into the device, and the device activates upon insertion of the blister card. The device transmits to a remote server that it has been activated and attempts an initial measurement. The controller includes retry logic. If the initial connection and / or blister measurement is unsuccessful, the device automatically retries to secure such a connection and perform the initial measurement. The retry logic may be configured to retry at specific time intervals, such as every 15 minutes, and the device may be programmed to activate at least once every 24 hours and perform dose inventory management on a blister card associated with the device.

[0018] Certain medication protocols require the user to remove one medication from the blister card daily. Alternatively, the medication protocol may require the user to remove multiple doses at different administration times daily. The user removes the medication from the medication blister card as needed. Thereafter, the device is activated and voltage / resistance measurements are obtained. When one or more medications are removed from the blister, the circuit associated with the specific blister that is torn is disconnected. When the blister circuit is disconnected, the voltage of the remaining circuits decreases and the resistance of the remaining circuits increases in a known manner, and these changes can correlate with inventory management of the removed medication and / or the medications remaining in the blisters on the medication card.

[0019] The above and other objects, features, and advantages of the present disclosure will become more apparent from the following detailed description, which proceeds with reference to the accompanying drawings.

Brief Description of the Drawings

[0020] [Figure 1] An end perspective view of a dose tracking device according to the present disclosure.

[0021] [Figure 2] A perspective view of an outer clam shell portion of a dose tracking device according to the present disclosure.

[0022] [Figure 3] An end view of a dose tracking device according to the present disclosure showing the use of alignment protrusions to facilitate alignment of an inserted blister card with the dose tracking device.

[0023] [Figure 4] A plan view of a dose tracking device according to the present disclosure in association with a commercially available blister pack containing multiple medications.

[0024] [Figure 5]A perspective view of a clamp according to one aspect of the present disclosure for firmly coupling a blister pack adjacent to a ruler to provide an estimated value of the clamp size to a dosage tracking device according to the present disclosure.

[0025] [Figure 6] A perspective view of an adhesive label according to one aspect of the present disclosure, comprising a circuit trace having a plurality of circuits for use in combination with a dosage tracking device according to the present disclosure.

[0026] [Figure 7] A plan view of a circuit board according to one aspect of the present disclosure for use in cooperation with a dosage tracking device according to the present disclosure.

[0027] [Figure 8] A perspective view of the back side of the circuit board of FIG. 7 showing a USB charging port, an LED housing, and a plurality of spring connectors for electrically connecting a dosage tracking device to a drug blister pack.

[0028] <000011​​​​​​​​​​​​​​​​​​​​​​

[0032] The following explanations of terms and abbreviations are provided to better describe this disclosure and to help those skilled in the art fully understand and practice aspects of this disclosure.

[0033] The singular forms "a," "an," or "the" include multiple references unless explicitly indicated otherwise in the context.

[0034] The term "or" refers to a single element or a combination of two or more elements of the listed alternative elements, unless otherwise clearly indicated in the context.

[0035] Unless otherwise specified, all technical and scientific terms used herein have the same meaning as those generally understood by those skilled in the art to which this disclosure pertains. This disclosure can be practiced or tested using methods and materials similar to or equivalent to those described herein, but suitable methods and materials are listed below. The materials, methods, and examples are illustrative and not intended to limit the scope. Other features of this disclosure will become apparent from the detailed description and claims.

[0036] Unless otherwise specified, the disclosure of a numerical range should be understood to refer to each discrete point within the range including the endpoints.

[0037] Unless otherwise indicated, all numbers used in the specification or claims to represent quantities, percentages, temperatures, times, etc., should be understood to be modified by the term “approximately.” Therefore, unless specifically implicitly or explicitly indicated, or unless the context is appropriately understood by those skilled in the art to have a more definitive configuration, the numerical parameters described are approximations that may depend on the desired properties and / or detection limits obtained under standard test conditions / methods known to those skilled in the art. Where aspects of this disclosure are directly and explicitly distinguished from the prior art discussed herein, numerical values ​​are not approximations unless the term “approximately” is enumerated.

[0038] While various components, parameters, and operating conditions described herein may have alternative forms, this does not necessarily mean that these alternative forms are equivalent and / or function equally well. Nor does it mean that the alternative forms are listed in preferred order unless otherwise stated.

[0039] Blister Cards: Blister packaging is a type of packaging manufactured by heating a sheet of plastic and molding it to form bubbles or pockets, which completely enclose the product and are called "blisters." Traditional blister packs are known as face-seal blisters and have a cardboard backing. Blister cards can be used to contain medications and provide patients with controlled single-unit or multi-unit doses. There is a direct correlation between the use of blister packs and improved patient adherence / loyalty to medication regimens. Blister packs provide a visual dose history and are generally easier to use, especially for patients taking multiple tablets per dose and those who have difficulty remembering appropriate dose protocols. While drug blister cards can vary in size and shape, drug blister cards are often rectangular, measuring 4 inches (10 cm) x 8 inches (20 cm).

[0040] Patient or subject: Refers to mammals and other animals, particularly humans. Therefore, the disclosed method is applicable to both human therapeutic and veterinary uses. The dose can be administered from a pack such as a blister pack, and the animals (human or non-human) include both human and veterinary subjects.

[0041] Treatment or therapy: Any of the terms include (1) preventing a disease, for example, preventing the development of clinical symptoms of a disease in a person who is potentially exposed to or susceptible to the disease but has not yet experienced or shown symptoms of the disease; (2) inhibiting a disease, for example, stopping the development of the disease or its clinical symptoms; or (3) reducing a disease, for example, causing regression of the disease or its clinical symptoms.

[0042] Unit dose: A drug or pharmaceutical composition in single-dose or measured-dose form (e.g., tablet, capsule, powder, or solution) to be administered as a single dose or multiple pre-selected doses.

[0043] II. Dose tracking devices

[0044] 1. Device

[0045] Figure 1 provides an external perspective view of the dose tracking device 10 according to this disclosure. Figure 2 is an enlarged end view of the dose tracking device shown in Figure 1. Figure 1 shows a design comprising a portion 12 molded to engage with and fit around a portion 14. The upper portion 12 is shown disassembled from portion 14 in Figure 2. The illustrated device 10 is sized to accommodate most commercially available blister cards, such as a 4-drug x 8-drug blister card. As used herein, the terms “drug” and “pharmaceutical” are interchangeable.

[0046] The upper portion 12 and bottom portion 14, which are mated together, define a receiving slot 16 into which a blister card is inserted for press-fitting. The device 10 may also include alignment protrusions 18, 20 (Figure 3) to facilitate proper device alignment with the inserted blister card. The alignment protrusions 18, 20 are used in conjunction with the device 10 to facilitate alignment with an adhesive circuit trace attached to the blister card, which is performed by an end user or the like. Figure 6 shows an adhesive circuit trace 60 according to one aspect of the present disclosure, which will be described in more detail below, comprising a front side 62 having a plurality of conductive metal (such as silver) pads 64, 66, 68, 70, 72, and 74. The alignment protrusions 18, 20 align with these pads 64 to pad 72. For example, protrusion 18 may align with the central portion of the conductive metal trace 64, and protrusion 20 may align with the central portion of trace number 74. Device 10 also includes multiple pairs of connection openings 46 for receiving connection pins for a spring-fueled electrical connector, as will be described in more detail with reference to Figure 8.

[0047] Those skilled in the art will understand that the dose tracking device does not need to be configured as a mating component design. The device can have an integrated design. As yet another alternative design, the device 10 may be configured as a clamshell device that closes around the blister pack, or as two separate components, one of which has a coupling component that penetrates the blister pack and connects the first component to the second component.

[0048] Device 10 can be fabricated from any suitable material. In certain aspects of this disclosure, device 10 is 3D printed using a suitable polymer material. Certain commercially available devices according to aspects of this disclosure are likely to be injection molded using a suitable polymer material such as ABS+PC plastic having a V-0 fire resistance rating (UL 94 V-0).

[0049] Figure 4 shows a dose tracking device 10 according to the present disclosure that interacts with a blister card 30 having multiple blisters 32 containing individual doses 34. Metal clamps 36, 38 securely interact with the device 10 to the blister card 30 while allowing for non-destructive reuse of the device 10. One device 10 according to one aspect of the present disclosure includes hinge clamps 36, 38 (see Figure 5) that flex when the blister card 30 is inserted and are then spring-biased to secure the device 10 to the blister card 30.

[0050] Referring to Figure 5, the metal (e.g., steel) clamp 36 includes a first end 50 and a plurality of teeth 52 that engage with the blister card 30 by rotation around 54. The illustrated clamp includes an L-shaped end 50. Those skilled in the art will understand that other shapes, such as J-shaped, are also effective. In certain embodiments of the present disclosure, a clamp 36 having a J-shaped end is used so that the J-shaped curve engages with a projection (not shown) to further lock the clamp in place. The clamp 36 is rotatably coupled to the device to facilitate the insertion and removal of the blister card. Thus, the clamp 36 includes a connecting pin slot 54 into which a connecting pin is inserted, and around which the clamp 36 can rotate in contact with and without contact with the blister card 30. To remove the device 10 from the card 30 after all doses have been administered, the user can remove the card by manually bending the clamp upward to separate it from the blister card.

[0051] Figures 1 and 3 also show that the device 10 may include slight indentations or shoulders 40, 42 and shelves 44. The shelves 44 in Figures 1 and 3 are small, with a depth of approximately 1 mm to 5 mm. The shoulders 40, 42 provide a slight constriction to the blister card 30 so that the card engages with the device 10 under tension and friction further secures the card to the device. These features, in combination with clamps 36, 38, help prevent the blister card 30 from moving relative to the device 10.

[0052] To record that a user has taken a dose from a blister, the dose tracking device 10 must be electrically connected to the blister card. This can be achieved using an adhesive circuit trace, as shown by the circuit trace 60 in Figure 6. As described above, the circuit trace 60 can be effectively electrically aligned with the dose tracking device 10 using alignment protrusions 18, 20. The circuit trace 60 comprises a printed upper portion 62 on which a plurality of electrical connection pads 64-74 are deposited / printed. Pads 64, 66, 68, 70, 72, and 74 are made from a conductive metal such as silver. The circuit trace 60 also includes a plurality of blister circuits 80 (horizontally oriented in Figure 6) that align with the drug blister 32 on the card 30. The circuit trace 60 also includes a plurality of connector traces 82 (vertically oriented in Figure 6) that interconnect the device 10 with each of the plurality of blister circuits 80. In certain aspects of this disclosure, the blister circuit 80 is made from a semiconducting material such as graphite or other carbon-based semiconducting ink, and the connector trace 82 is made from a low-resistance or no-resistance material such as silver. In certain aspects of this disclosure, the circuit is manufactured using conductive carbon paste CP-100, which is specifically designed for printing flexible printed circuits. The connector trace 82 is applied in certain aspects of this disclosure using a silver flake / polyester resin composition, such as one available from Guangdong Nanhai ETEB Technology Co., Ltd., Foshan City, China.

[0053] One method for tracking the medication being removed from a blister card involves electrically coupling individual circuits to each blister, where the circuits are either intact before removal or disconnected after removal. This technique is an on:off configuration and requires circuit tracing to have 32 separate circuits for a blister card with 32 blisters. The device shown in Figure 6 reduces the number of circuits required for operation in the individual circuits coupled to each blister from 32 to 4, and the device measures the electrical resistance across the entire circuit. The 4 circuits are coupled to multiple blisters 32 arranged vertically in 4 columns. By using a semiconducting material, the circuit voltage decreases and the circuit resistance increases predictably as the medication is removed from each blister 32. This offers several advantages beyond simply reducing the complexity of the electrical circuit. For example, after some doses have been removed, the number of remaining doses can be determined by correlating the circuit voltage or resistance with the number of broken or unbroken blisters 32. Current flows through eight paths corresponding to eight blister circuits 80 through which current can flow. If a single blister 32 is disconnected, the voltage in the circuit connected to that blister decreases, and the resistance of that circuit increases by approximately 12.5% ​​(100 / 8 traces). If a second blister on the same circuit is disconnected, the circuit voltage decreases, and the resistance increases by approximately 14% (100 / 7 traces), and so on. Finally, when the last agent on a particular circuit is disconnected, no current flows because each of the specific electrical circuit paths is disconnected.

[0054] Figure 7 is a plan view of the circuit board 100. The board 100 includes an on / off switch 102 and a number of sensor pins 104 for electrical connections to each of the pads 64-74 of the circuit trace 60. Those skilled in the art will understand that the number of sensor pins 104 is variable, and the number of electrical contact pads and circuits printed on the circuit trace 60 is also variable.

[0055] The dose tracking device 10 is also configured to transmit data. The illustrated device 10 is specifically designed as a cellular connectivity device and therefore includes an NB-IoT module or a combination of an NB-IoT module and an LTE CAT-M1 module 106. Device 10 does not necessarily have to be a cellular connectivity device. Other data transmission techniques, including Bluetooth, WiFi, or a combination thereof, are also suitable.

[0056] The board functions are controlled by a microcontroller 108. Data generated by device 10 can be transmitted to and / or stored on a memory card such as a nano-SIM card 110. Device 10 also includes a power source such as a rechargeable battery (not shown), and certain aspects of this disclosure include a USB Type-C charger 112. A USB I / O port 114 is shown in Figure 8. Optionally, device 10 may include an LED 116 to indicate specific functions, such as when the device is powered on or off, or when it is charging or not charging. An LED housing 118 is shown in Figure 8.

[0057] Figure 8 provides a perspective view of the back of the control board 100. As described above, the board 100 includes a USB port 114 and an LED housing 118. The board 100 also includes several electrical connectors, such as spring connectors 120, 122, 124, 126, 128, and 130. When the blister card 30 is inserted into the device 10, the spring-biased connectors 120-130 flex to accept the card and then attempt to return due to spring bias, thereby providing a secure electrical connection with the silver trace pads 64, 66, 68, 70, 72, and 74 on the circuit trace 60. These spring-biased connectors 120-130 are robust and can function properly over the typically assumed device lifespan. However, those skilled in the art will understand that various other methods can also be used to electrically connect the device 10 to the circuit trace 60, such as conductive metal pogo pins or leaf springs that engage with the circuit trace when the device 10 is positioned in conjunction with the blister card.

[0058] When the dose tracking device 10 is ready for use, the battery pull tab (not shown) is removed. A blister card is inserted into slot 16, and the device is powered on to attempt an initial measurement. If the device is properly connected to the blister card and connected to the server, the device sends a message to the server indicating that it has been powered on. In some embodiments, the connection is cellular, short-range wireless (e.g., Bluetooth® wireless technology, Bluetooth SIG, Inc., Kirkland, WA), or WiFi connection. If the initial connection is unsuccessful, the controller includes retry logic, and the system automatically retries obtaining such a connection and / or performing voltage / resistance measurements. This retry logic can be set to a specific time interval, such as every 15 minutes, and a specific number of connection attempts, such as three or more. The device is programmed to power on at least once every 24 hours, for example, to check the management of dose inventory on a linked blister card. The device operates for extended periods, such as up to 120 days on a single charge, to transmit tablet usage. Certain medication plans require taking multiple doses at multiple different times. By being activated periodically, device 10 can perform inventory management that takes such a medication plan into account. Furthermore, by performing periodic measurements, certain aspects of the present disclosure can be configured to determine the approximate time when a dose was taken.

[0059] Embodiments of the kit include a dose tracking device as disclosed herein and instructions for using the dose tracking device. In some embodiments, the kit further includes a drug blister card.

[0060] 2. Software / Remote Data (Date) Acquisition The dose tracking device of this disclosure is specifically designed to transmit data to a remote server where the data can be stored and medication retrieval can be monitored by an administrator. Figure 9 illustrates specific steps for an exemplary administrator workflow 900. The first action for the administrator 902 is to create a new location and location type. As used herein, a location may refer to a subject for maintaining patient confidentiality. Patients do not need to be unique, but an alert can be displayed if another patient is identified at the same location. The administrator then adds the new dose tracking device to the location in step 904 and prepares (configures) medication blister cards for use at the location in step 906.

[0061] Figure 10 illustrates specific steps for an exemplary workflow 1000 for medication professionals such as pharmacists, physicians, hospitals, or clinical trial administrators. In the first step 1002, the professional creates new patient location information in the patient management module. The patient location is then associated with a specific medication to be administered to that patient in step 1004. In step 1006, the dose tracking configuration module configures a specific dose tracking device to be used by a particular patient. In step 1008, a prescription is added for the patient in prescription management. Then, in step 1010, a dose tracking alert is added to the dose tracking patient dashboard, and in step 1012, a test alert email is generated for the patient dose tracking dashboard.

[0062] Figure 11 shows specific steps related to an exemplary pharmacy workflow 1100, such as a dispensing pharmacy workflow. In step 1102, the pharmacy can monitor the patient's treatment using a medication calendar. Once the medication is dispensed by the patient, the pharmacy can monitor the dispensed medication in a dose tracking history report in step 1104. The pharmacy can then monitor the remaining dose on the blister card in step 1106.

[0063] III. Typical Modes

[0064] Specific representative embodiments are illustrated in the following numbered sections.

[0065] 1. A dose tracking device configured for use in conjunction with commercially available drug blister cards.

[0066] 2. The dose tracking device according to Section 1, comprising an electronic tracking module having multiple voltage sensors electrically coupled to a circuit trace applied to a pharmaceutical blister card, wherein the circuit of the trace is aligned with a pharmaceutical blister containing a drug dose, and when a dose is removed from the blister, the circuit corresponding to the circuit trace is disconnected, the total circuit voltage is reduced, the total circuit resistance is increased, and thus indicates that the dose has been removed.

[0067] 3. The device according to Section 2, wherein the circuit trace comprises a plurality of conductive metal pads configured to provide electrical connections to the device, and a plurality of semiconductive circuit traces that align with the blister on the pharmaceutical blister card.

[0068] 4. The device according to Section 3, wherein the conductive metal is silver, and the semiconductive portion is to which a carbon-based ink is applied.

[0069] 5. The device according to any one of sections 1 to 4, comprising a blister card receiving slot having a size that allows the blister card to be press-fitted into the device.

[0070] 6. The device according to any one of sections 1 to 5, comprising a shoulder that engages with an inserted blister card, causing a slight constriction in the inserted blister card, thereby causing the card to engage with the device under tension and further securing the card to the device.

[0071] 7. The device according to any one of sections 1 to 6, further comprising a shelf that contacts at least a portion of the blister card and further prevents the blister card from moving relative to the device.

[0072] 8. The device according to any one of sections 1 to 7, further comprising a plurality of metal clamps for securely attaching the device to the blister card.

[0073] 9. The device according to Section 8, wherein the clamp flexes when the blister card is inserted and then returns to an unflexed position to secure the device to the blister card.

[0074] 10. The device according to Section 8 or Section 9, comprising a J-shaped clamp that engages with a clamping projection to lock the clamp in place.

[0075] 11. The device according to any one of sections 1 to 10, comprising alignment protrusions for facilitating the alignment of the device, the blister pack, and the circuit trace.

[0076] A device as described in any one of sections 1 through 11, configured for use with a 12.4 x 8 inch blister card.

[0077] 13. A device according to any one of sections 1 to 12, wherein the circuit voltage and resistance change predictably as the pharmaceutical is removed from each blister.

[0078] 14. The device according to Section 13, wherein the number of remaining doses on the blister on the blister card can be determined by correlating the circuit voltage or resistance with the number of ruptured or unruptured blisters.

[0079] 15. A device according to any one of sections 1 to 14, comprising a control board for controlling the device's functions.

[0080] 16. The device according to Section 15, comprising a plurality of electrical connectors for electrical connection to the circuit trace.

[0081] 17. The device described in Section 16, wherein the plurality of electrical connectors are spring-biased connectors, pin connectors, leaf spring connectors, or any combination thereof.

[0082] 18. The device described in Section 16, wherein the plurality of electrical connectors are spring-biased connectors.

[0083] 19. A device as described in any one of Sections 1 to 18, comprising a microcontroller, a rechargeable power supply, a USB port, and / or one or more LEDs indicating on / off and / or charging status.

[0084] 20. A device described in any one of Sections 1 to 19, which further cooperates with a remote server for receiving data from the aforementioned device.

[0085] 21. The device according to Section 20, wherein the device has retry logic for attempting to connect with the blister card and / or periodically sending data to the remote server.

[0086] 22. The device described in Section 19, which attempts to connect every 15 minutes.

[0087] 23. The device described in Section 19, which attempts to connect at least once every 24 hours.

[0088] 24. The device is a cellular connectivity device, a Bluetooth device, a Wi-Fi device, or any combination thereof, as described in any one of Sections 1 to 23.

[0089] 25. A device as described in Section 24, comprising a cellular connectivity device.

[0090] 26. Such a device is one of the devices described in any one of Sections 1 to 25, which is injection molded or 3D printed from a polymer material.

[0091] 27. A device as described in any one of sections 1 to 26, comprising an integrated device, a clamshell device, or a device having separable components.

[0092] 28. A dose tracking device configured for use in conjunction with a commercially available drug blister card, wherein the device comprises a tracking module having: A receiving slot sized to allow press-fitting of a commercially available pharmaceutical blister card inserted into the device, wherein the device further comprises a shoulder that engages with the inserted blister card, causing a slight constriction in the inserted blister card, thereby causing the card to engage with the device under tension, and a shelf that contacts at least a portion of the blister card to further prevent the blister card from moving relative to the device; Multiple voltage sensors configured to electrically couple to the circuit trace attached to the pharmaceutical blister when the card and circuit trace are inserted into the device, wherein the circuit trace comprises multiple conductive metal pads configured to provide an electrical connection to the device, and multiple semiconductive circuit traces that align with the blister on the pharmaceutical blister card, so that when a dose is dispensed from the blister, the circuit corresponding to the circuit trace is disconnected, thereby reducing the total circuit voltage, increasing the total circuit resistance, and indicating that the dose has been dispensed; Alignment protrusions that facilitate the alignment of the device, the blister pack, and the circuit trace; A plurality of metal clamps that hold the blister card in a predetermined position relative to the device; and A control board for controlling device functions, comprising a microcontroller, a rechargeable power supply, a USB port, and / or LEDs indicating on / off and / or charging status.

[0093] 29. The device according to Section 28, wherein the conductive metal is silver, and the semiconductive portion is to which graphite ink is applied.

[0094] 30. The device according to Section 28, comprising a J-shaped clamp that bends when a blister card is inserted and then returns to an unbent position to secure the device to the blister card.

[0095] 31. A device as described in any one of sections 28 to 30, comprising an integrated device, a clamshell device, or a device having separable components.

[0096] A device as described in any one of sections 28-31, configured for use with a 32.4 x 8 inch blister card.

[0097] 33. A device described in any one of sections 28 to 32, which further cooperates with a remote server for receiving data from the aforementioned device.

[0098] 34. The device according to any one of sections 28 to 33, wherein the device periodically attempts to connect with the blister card and / or attempts to send data to the remote server, with retry logic included.

[0099] 35. The device is a cellular connectivity device, a Bluetooth device, a Wi-Fi device, or any combination thereof, as described in any one of Sections 28 to 34.

[0100] 36. Adhesive circuit traces configured to make electrical connections to any of the devices described in Sections 1 to 35.

[0101] 37. A front side having multiple conductive metal pads for electrically coordinating with a dose tracking device, wherein the front side further comprises multiple circuits electrically coupled to the conductive metal pads, the multiple circuits being aligned with the blisters on the blister card and further configured to measure voltage or resistance across each individual circuit aligned with each drug blister; and The back side has an adhesive substance for fixing the circuit trace to the drug blister card. The adhesive circuit trace described in Section 36, comprising:

[0102] 38. Devices described in any one of Sections 1 to 35; and A pharmaceutical blister card, wherein the card has an adhesive circuit trace as described in any one of sections 36 to 37, which is applied to the card and electrically interacts with the device. A combination that includes these features.

[0103] 39. A method comprising using a dose tracking device described in any one of Sections 1 to 38, a combination comprising the dose tracking device, or a circuit trace.

[0104] 40. The method described in Section 39, which includes providing a dose tracking device to the user.

[0105] 41. The method according to Section 40, wherein the user is instructed to insert the drug blister card into the device in order to properly align the trace with the electrical sensor on the device.

[0106] 42. The method according to Section 40, comprising inserting the drug blister card into the device.

[0107] 43. The method described in Section 42, wherein the user removes the drug from the drug blister card.

[0108] 44. The device is activated when a blister card is inserted, and the device attempts an initial measurement, as described in Section 39.

[0109] 45. The method according to Section 44, wherein the device is properly connected to the blister card, and the device transmits to a remote server that it has been started.

[0110] 46. ​​The method according to Section 44, wherein the controller has retry logic, and if the initial connection is unsuccessful, the device automatically retries to secure such a connection.

[0111] 47. The method described in Section 46, wherein the retry logic can be configured to retry at specific time intervals.

[0112] 48. The method described in Section 47, wherein the time interval is every 15 minutes.

[0113] 49. The method according to Section 39, wherein the device is programmed to be activated at least once every 24 hours and to perform dose inventory management on a blister card that works in conjunction with the device.

[0114] 50. The method according to any one of Sections 39 to 49, wherein the medication plan requires the user to remove one drug from the blister card each day.

[0115] 51. The medication plan described in any one of sections 39 to 49, which requires the user to take multiple doses daily at different times.

[0116] IV. Examples

[0117] The following embodiments are provided to illustrate certain features of the disclosed aspects of this disclosure. Those skilled in the art will understand that the scope of this disclosure is not limited to such features.

[0118] [Example 1]

[0119] This embodiment relates to using a disclosed embodiment of a dose-tracking device to provide a near real-time monitoring system for orally administered drugs such as anticancer drugs. Patient adherence to a drug administration plan is important, and the plan varies depending on the drug. For example, oral anticancer drugs are included in standard treatment for each type of cancer. Certain anticancer drugs include drug-free periods, while others must be taken on an empty stomach.

[0120] A real-time drug monitoring system was developed for Cancer Research Ariake Hospital and its browser-based web portal. This system encapsulates anticancer drugs in drug packs equipped with communication terminals. A No. 0 capsule was sealed in the drug pack, and information about drug removal was transmitted to a server in near real-time as soon as the drug was removed. The system tracked the time the drug was removed and the time it was received by the server. When a drug was removed at Cancer Research Ariake Hospital, the event was reported to a secure browser-based web portal via a remote server within two minutes of the event, e.g., within 2-20 minutes.

[0121] More specifically, confidential patient trials of dose-tracking devices were conducted. In one such trial, blister cards were inserted into 10 different dose-tracking devices. The devices transmitted the date and time each blister card was inserted into the device to a remote server. The drug dose was then removed from the blister card by the subject according to an established plan, and this information was transmitted to the remote server. Representative data for one such trial involving 10 patients is shown in Table 1 below. The collected data included, among other things, which tablet was removed from the blister card (e.g., row 3, tablet 2, highlighted in row 1 of Table 1) and at what time it was removed (e.g., 9 a.m.).

[0122] [Table 1]

[0123] This embodiment demonstrated that medication adherence can be assessed in near real-time using the disclosed dose tracking device. Similar tests were conducted daily for one week. Evaluators stated that the disclosed embodiment of the device “worked perfectly” during these tests.

[0124] Given the many possible embodiments to which the principles of this disclosure may be applied, it should be recognized that the disclosed embodiments are merely examples and do not limit the scope of the invention. Rather, the scope of the invention is defined by the following claims. Accordingly, everything that falls within the scope and spirit of these claims is claimed to be the invention.

Claims

1. A dose tracking device configured for use in conjunction with drug blister cards.

2. A dose tracking device according to claim 1, comprising an electronic tracking module having a plurality of voltage sensors electrically coupled to a circuit trace applied to a drug blister card, wherein the circuit of the circuit trace is aligned with a drug blister containing a drug dose, and when a dose is removed from the blister, the circuit corresponding to the circuit trace is disconnected, the total circuit voltage is reduced, the total circuit resistance is increased, and thus indicates that the dose has been removed.

3. The circuit trace is A plurality of conductive metal pads configured to provide electrical connections to the dose tracking device, Multiple semiconductive circuit traces that align with the blister on the drug blister card Equipped with, In particular, the conductive metal is silver, and the semiconductive portion is to which carbon-based ink is applied. The dose tracking device according to claim 2.

4. (i) A blister card receiving slot sized to allow the drug blister card to be pressed into the dose tracking device, or (ii) A shoulder that engages with the inserted drug blister card, causing a slight constriction in the inserted drug blister card, thereby engaging the drug blister card with the device under tension, and further securing the drug blister card to the device, or (iii) A shelf that comes into contact with at least a portion of the inserted drug blister card, further preventing the inserted drug blister card from moving relative to the device, or (iv) Alignment projections that facilitate the alignment of the device, the drug blister card, and the circuit trace, or (v) Any combination of two or more of (i), (ii), (iii), and (iv) A dose tracking device according to any one of claims 1 to 3, further comprising:

5. The dose tracking device according to any one of claims 1 to 4, further comprising a plurality of metal clamps that securely engage the dose tracking device with the drug blister card, wherein the clamps flex when the drug blister card is inserted and then return to an unflexed position to secure the dose tracking device to the drug blister card.

6. The dose tracking device according to claim 5, further comprising a J-shaped clamp that engages with a clamp projection to lock the clamp in place.

7. A dose tracking device according to any one of claims 1 to 6, wherein the circuit voltage and resistance change predictably as the pharmaceutical is removed from each blister, and in particular the number of doses remaining in the blisters on the drug blister card can be determined by correlating the circuit voltage or resistance with the number of torn or untorn blisters.

8. The dose tracking device according to any one of claims 1 to 7, further comprising a control board for controlling the device functions.

9. The dose tracking device according to claim 8, further comprising a plurality of electrical connectors for electrical connection to the circuit trace, wherein the plurality of electrical connectors are spring-biased connectors, pin connectors, leaf spring connectors, or any combination thereof.

10. Microcontroller, rechargeable power supply, USB port, and / or On: LED indicating off and / or charging status A dose tracking device according to any one of claims 1 to 9, further comprising one or more of the above.

11. The dose tracking device comprises a tracking module having the following: The dose tracking device further comprises a receiving slot sized to allow press-fitting of a commercially available drug blister card inserted into the dose tracking device, wherein the dose tracking device further comprises a shoulder that engages with the inserted drug blister card, causing a slight constriction in the inserted drug blister card, thereby causing the card to engage with the device under tension, and a shelf that contacts at least a portion of the drug blister card to further prevent the drug blister card from moving relative to the device; Multiple voltage sensors configured to electrically couple to the circuit trace attached to the drug blister when the drug blister card and circuit trace are inserted into the device, wherein the circuit trace comprises multiple conductive metal pads configured to provide an electrical connection to the device, and multiple semiconductive circuit traces that align with the blister on the drug blister card, so that when a dose is dispensed from the blister, the circuit corresponding to the circuit trace is disconnected, thereby reducing the total circuit voltage and increasing the total circuit resistance, indicating that the dose has been dispensed; Alignment protrusions that facilitate alignment of the device, the drug blister card, and the circuit trace; A plurality of metal clamps that hold the drug blister card in a predetermined position relative to the device: and A control board for controlling device functions, comprising a microcontroller, a rechargeable power supply, a USB port, and / or LEDs indicating on / off and / or charging status. The dose tracking device according to claim 1.

12. The dosage tracking device according to claim 11, further comprising a J-shaped clamp that bends when a drug blister card is inserted and then returns to an unbent position to secure the device to the drug blister card.

13. A dose tracking device according to any one of claims 1 to 12, comprising an integrated device, a clamshell device, or a device comprising separable components.

14. The dose tracking device according to any one of claims 1 to 13, configured for use with a 4-inch x 8-inch blister card.

15. The dose tracking device according to any one of claims 1 to 14, further cooperating with a remote server for receiving data from the aforementioned device.

16. The device further comprises retry logic that periodically attempts to connect with the drug blister card and / or attempts to send data to the remote server, especially, The device attempts to connect every 15 minutes, or The device attempts to connect at least once every 24 hours. The dose tracking device according to claim 15.

17. The dose tracking device according to any one of claims 1 to 16, wherein the device is a cellular connectivity device, a short-range wireless device, a Wi-Fi device, or any combination thereof.

18. An adhesive circuit trace configured to make an electrical connection with a dose tracking device according to any one of claims 1 to 17, A front side comprising a plurality of conductive metal pads for electrically coordinating with a dose tracking device, the front side further comprising a plurality of circuits electrically coupled with the conductive metal pads, the plurality of circuits being configured to align with a blister on a drug blister card and to measure voltage or resistance across each individual circuit aligned with each drug blister, The back side is provided with an adhesive substance for fixing the circuit trace to the drug blister card. Adhesive circuit traces equipped with these features.

19. A dose tracking device according to any one of claims 1 to 17, A drug blister card comprising an adhesive circuit trace according to claim 18, which is applied to the card and electrically coupled with the device. A combination that includes these features.

20. A method comprising using a dose tracking device according to any one of claims 1 to 17 or a combination according to claim 19.

21. The method according to claim 20, further comprising providing the dose tracking device to a user, in particular the user being instructed to insert the drug blister card into the device in order to properly align the trace with an electrical sensor on the device.

22. The method according to claim 21, further comprising inserting the drug blister card into the dose tracking device.

23. The dose tracking device is activated when the drug blister card is inserted, and the dose tracking device attempts an initial measurement, in particular, The dose tracking device is appropriately connected to the drug blister card, and the dose tracking device transmits to the remote server that it has been activated, or The controller has retry logic, and if the initial connection is unsuccessful, the dose tracking device automatically retries to secure the initial connection, and in particular, the retry logic can be configured to retry at specific time intervals. The method according to claim 20.

24. The method according to claim 20, wherein the dose tracking device is programmed to be activated at least once every 24 hours and to perform dose inventory management on a drug blister card that works in conjunction with the dose tracking device.

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