SYSTEM AND METHOD FOR MEDICATION COMPLIANCE AND DRUG ABUSE PREVENTION
20220192927 · 2022-06-23
Inventors
Cpc classification
A61J7/0445
HUMAN NECESSITIES
A61J2200/70
HUMAN NECESSITIES
G01G19/52
PHYSICS
G06F3/017
PHYSICS
A61J2205/70
HUMAN NECESSITIES
G16H10/60
PHYSICS
G08B21/182
PHYSICS
G16H40/40
PHYSICS
G16H20/10
PHYSICS
G16H50/00
PHYSICS
International classification
A61J7/04
HUMAN NECESSITIES
G01G19/52
PHYSICS
G16H10/60
PHYSICS
G16H20/10
PHYSICS
G16H40/40
PHYSICS
Abstract
A medication compliance and drug abuse prevention device for use as a cap with conventional medication container. The neck of the cap is adapted for mating with the neck of any conventional medication container. The mating of the cap neck with the container neck forms a seal therebetween and the seal can be maintained in a locked or unlocked state as per requirement. The cap has a weighment module configured to measure a mass of a medicinal substance contained inside the container. A control module determines a difference in the mass of the medicinal substance measured before and after the unlocked state and initiate one or more alert actions if the difference in mass of the medicinal substance is found to be less than or more than a prescribed mass of medicinal substance.
Claims
1. A medication compliance and drug abuse prevention device for use as a cap with a medicine container, said device comprising: a main body comprising a top end, a bottom end and a side wall extending between said top end and said bottom end, said side wall defining a cap internal compartment, wherein said cap internal compartment opens at said top end; a cap neck disposed at said top end, said cap neck adapted for mating with a container neck of a container and forming a seal therewith, wherein said cap neck in association with said container neck defines a passage between said cap internal compartment and a container internal space of said container; a locking mechanism disposed at said cap neck, said locking mechanism being capable of maintaining said seal in a locked state or in an unlocked state as per requirement; a weighment module disposed inside said cap internal compartment, said weighment module configured to measure a mass of a medicinal substance contained inside said container internal space; and a control module comprising a processor, said processor being configured to execute one or more instructions to: configure said locking mechanism to maintain said seal in said locked state for a first specific period of time; configure said locking mechanism to maintain said seal in said unlocked state for a second specific period of time; determine a difference in said mass of said medicinal substance by comparing a first value of said mass of said medicinal substance measured in said locked state with a second value of said mass of said medicinal substance measured in said locked state after said unlocked state; and enable said control module to initiate one or more alert actions if said difference in said mass of said medicinal substance is found to be less than or more than a prescribed mass of medicinal substance.
2. The device of claim 1, wherein said main body further comprises a built-in user interface.
3. The device of claim 1, wherein said locking mechanism comprises a collar, an actuator and one or more teeth.
4. The device of claim 3, wherein said collar is adapted to snugly fit around an unthreaded area of said container neck and said one or more teeth get engaged with said collar in said locked state.
5. The device of claim 1, wherein said first specific period of time and said second specific period of time are predetermined period of time as per one or more medication instructions for said medicinal substance and/or as per result of a user authentication process.
6. The device of claim 5, wherein said user authentication process includes successful verification of a unique code or a user information.
7. The device of claim 1, wherein said one or more alert actions initiated when said difference in said mass of said medicinal substance is found to be more than said prescribed mass of medicinal substance includes an action on maintaining said locked state until a manual override instruction is received by said control module.
8. The device of claim 1, wherein said one or more instructions are received from a computing device and/or from a remote server, said control module being communicatively connected to said computing device and/or to said remote server over a network.
9. The device of claim 1, wherein said one or more alert actions include an audible alarm emitted by a speaker disposed on said main body and/or a visual alarm emitted by a light source disposed on said main body.
10. A system for medication compliance and drug abuse prevention, said system comprising: a medication compliance cap for use with a container, said medication compliance cap comprising a cap internal compartment, a cap neck adapted for mating with a container neck of said container and forming a seal therewith, a locking mechanism capable of locking said seal, a weighment module configured to measure a mass of a medicinal substance contained inside said container and a control module; and a first computing device communicably connected to said medication compliance cap, said first computing device comprising one or more physical processors programmed with computer program instructions that, when executed by said one or more physical processors, program said first computing device to: configure said locking mechanism to maintain said seal in a locked state or in an unlocked state as per requirement; determine a difference in said mass of said medicinal substance measured before and after said unlocked state; and initiate one or more alert actions if said difference in said mass of said medicinal substance is found to be less than or more than a prescribed mass of medicinal substance.
11. The system of claim 10, wherein said first computing device is further configured to identify said medication compliance cap by a unique identity.
12. The system of claim 11, wherein said first computing device is further configured to associate each of said unique identity of a plurality of said medication compliance caps with a user account of a user through a user interface provided on said first computing device.
13. The system of claim 11, wherein said first computing device is further configured to enable association of one or more data with respect to said medicinal substance with said unique identity of said medication compliance cap.
14. The system of claim 12, wherein said first computing device is further configured to enable presenting of one or more medication instructions with respect to said plurality of said medication compliance caps associated with said user account through said user interface of said first computing device.
15. The system of claim 14, wherein said first computing device is further configured to interact with a second computing device communicably connected with said first computing device for said one or more medication instructions and/or for said one or more alert actions.
16. The system of claim 10, wherein said one or more alert actions include keeping said locked state maintained until a manual override instruction is activated through said control module if said difference in said mass of said medicinal substance is found to be more than said prescribed mass of medicinal substance.
17. The system of claim 10, wherein said medication compliance cap is configured to detect an orientation of said medication compliance cap and initiate said one or more alert actions if said medication compliance cap is not kept in a right position.
18. The system of claim 12, wherein said medication compliance cap is configured to detect one or more gestures, made by said user, with the help of a gesture detection module included in said medication compliance cap.
19. The system of claim 12, wherein said unlock state of each of said plurality of said medication compliance caps is set in a specific sequence.
20. The system of claim 12, wherein said unlock state is activated and an emergency visual and/or audible notification is triggered on detection of an emergency medical condition of said user associated with said user account.
21. A method for medication compliance and drug abuse prevention, said method comprising: providing a medication compliance cap for use with a container, said medication compliance cap comprising a cap internal compartment, a cap neck adapted for mating with a container neck of said container and forming a seal therewith, a locking mechanism capable of locking said seal, a weighment module configured to measure a mass of a medicinal substance contained inside said container and a control module; configuring a first computing device to present a user interface on said first computing device, said first computing device being communicably connected to said medication compliance cap; associating a unique identity of said medication compliance cap with a user account using said user interface; associating one or more data with respect to said medicinal substance contained in said container with said unique identity of said medication compliance cap; storing one or more medication instructions with respect to said medicinal substance; configuring said locking mechanism to maintain said seal in a locked state or in an unlocked state as per said one or more medication instructions and/or as per a user authentication process; determining a difference in a mass of said medicinal substance measured before and after said unlocked state; and initiating one or more alert actions if said difference in said mass of said medicinal substance is found to be less than or more than a prescribed mass of medicinal substance as per said one or more medication instructions.
22. The method of claim 21, wherein said one or more alert actions include keeping said locked state maintained until a manual override instruction is activated through said control module if said difference in said mass of said medicinal substance is found to be more than said prescribed mass of medicinal substance.
23. The method of claim 21, wherein said user authentication process includes successful verification of a unique code or a user information.
24. The method of claim 21, wherein said first computing device is further configured to interact with a second computing device communicably connected with said first computing device for said one or more medication instructions and/or for said one or more alert actions.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0031] The accompanying drawings, which are incorporated herein and form a part of the specification, illustrate the present invention and, together with the description, further serve to explain the principles of the invention and to enable a person skilled in the relevant art to make and use the invention. The present invention will become more fully understood from the detailed description given herein below and the accompanying drawings which are given by way of illustration only, and thus are not limitative of the present invention, and wherein:
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[0052] The present invention will now be described with reference to the accompanying drawings. In the drawings, generally, like reference numbers indicate identical or functionally similar elements. Additionally, generally, the left-most digit(s) of a reference number identifies the drawing in which the reference number first appears.
DETAILED DESCRIPTION OF THE INVENTION
[0053] The following detailed description of the present invention refers to the accompanying drawings that illustrate exemplary embodiments consistent with this invention. Other embodiments are possible, and modifications can be made to the embodiments within the spirit and scope of the invention. Therefore, the detailed description is not meant to limit the invention. Rather, the scope of the invention is defined by the appended claims.
[0054] It would be apparent to one of skill in the art that the present invention, as described below, can be implemented in many different embodiments of software, hardware, firmware, and/or the entities illustrated in the figures. Any actual software code with the specialized control of hardware to implement the present invention is not limiting of the present invention. Thus, the operational behavior of the present invention will be described with the understanding that modifications and variations of the embodiments are possible, given the level of detail presented herein.
[0055] Reference now will be made in detail to embodiments of the invention, one or more examples of which are illustrated in the drawings. Each example is provided by way of explanation of the invention, not limitation of the invention. In fact, it will be apparent to those skilled in the art that various modifications and variations can be made in the present invention without departing from the scope or spirit of the invention. For instance, features illustrated or described as part of one embodiment can be used with another embodiment to yield a still further embodiment. Thus, it is intended that the present invention covers such modifications and variations as come within the scope of the appended claims and their equivalents.
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[0057] The present invention is a device, system and method for ensuring medication compliance and preventing drug abuse. As a part of the system of the present invention, a medication compliance and drug abuse prevention device is provided which can work alone or in association with one or more remotely connected additional computing devices configured to help the device and users of the device to ensure medication compliance and drug abuse prevention. The medication compliance and drug abuse prevention device of the present invention can be used as a cap for any conventional medication container/bottle 100 in place of the original cap of the container. The same medication compliance and drug abuse prevention cap can be reused with another medication container after it is used with a first container or bottle. For each container/bottle of orally taken medicine, a user will need one medication compliance and drug abuse prevention cap. The terms medicine and medication are used herein alternatively and interchangeably. The cap of the present invention can be made to fit with any standard medicine container or bottle. For screw-on or threaded type of conventional container, the cap of the present invention can be made as a screw-on type cap 200 as shown in
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[0059] Reference to
[0060] The medication compliance cap 200 further comprises a power source 212, a speaker 216, one or more light sources 218 and a cap user interface 224 as shown in
[0061] A snap-on type of medication compliance cap 300, which is the second embodiment of the present invention, is illustrated in
[0062] In case of the embodiment of the present invention in which the medication compliance cap is provided without any accompanying container, the original cap of a conventional medicine container, in which medicine/medicinal substance is bought/supplied, is required to be replaced with the medication compliance cap by the user before start of medication.
[0063] In one embodiment, reference to
[0064]
[0065] In an attached position, the cap neck of the medication compliance cap, in association with the container neck, defines a passage between the cap internal compartment and the container internal space.
[0066]
[0067] The cap communication module 904 is configured to enable communication of the medication compliance cap with other devices. Such communication can be performed wirelessly (by radio frequency or infrared communication, for example), or by wire. Communication module 904 is hardware and software configured to transmit data to and from the medication compliance cap. For example, the communication module 904 is configured to transmit data from the medication compliance cap to one or more computing devices 1000A (referred to as first computing device) and 1000B (referred to as second computing device) and to a MEDCOMAP system server 1101 as shown in
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[0069] Computing device 1000 may be implemented as a single apparatus, system, or device or may be implemented in a distributed manner as multiple apparatuses, systems, or devices. Reference to
[0070] Device processor 1008 loads and executes instructions of MEDCOMAP app 1006 from device memory 1004. When executed by device processor 1008, for medication compliance and abuse prevention, instructions direct device processor 1008 to operate as described herein for at least the various processes, operational scenarios, and sequences discussed in the following implementations. Computing device 1000 may optionally include additional devices, features, or functionality not discussed for purposes of brevity.
[0071] Referring still to
[0072] Device memory 1004 may comprise any computer readable storage media readable by device processor 1008 and capable of storing instructions 1005 including MEDCOMAP app and web browser. Device memory 1004 may include volatile and nonvolatile, removable and non-removable media implemented in any method or technology for storage of information, such as computer readable instructions 1005, data structures, program modules, or other data. Examples of storage media include random access memory, read only memory, magnetic disks, optical disks, flash memory, virtual memory and non-virtual memory, magnetic cassettes, magnetic tape, magnetic disk storage or other magnetic storage devices, or any other suitable storage media.
[0073] In particular, the program instructions may include various components or modules that cooperate or otherwise interact to carry out the various processes and operational scenarios described herein. The various components or modules may be embodied in compiled or interpreted instructions, or in some other variation or combination of instructions. The various components or modules may be executed in a synchronous or asynchronous manner, serially or in parallel or in accordance with any other suitable execution paradigm, variation, or combination thereof. Instructions 1005 may include additional processes, programs, or components, such as operating system software, virtual machine software, or other application software, in addition to or that include MEDCOMAP app. Instructions 1005 may also comprise firmware or some other form of machine-readable processing instructions executable by device processor 1008.
[0074] In general, instructions 1005 may, when loaded into processor 1008 and executed, transform a suitable apparatus, system, or device (of which computing device 1000 is representative) overall from a general-purpose computing system into a special-purpose computing system customized to facilitate medication compliance and drug abuse prevention.
[0075] Device communication module 1002 may include communication connections and devices that allow for communication with other computing systems (devices shown in
[0076] User interface module 1010 may include a keyboard, a mouse, a voice input device, a touch input device for receiving a touch gesture from a user, a motion input device for detecting non-touch gestures and other motions by a user, and other comparable input devices and associated processing elements capable of receiving user input from a user. Output devices such as a display, speakers, haptic devices, and other types of output devices may also be included in user interface module 1010. In some cases, the input and output devices may be combined in a single device, such as a display capable of displaying images and receiving touch gestures.
[0077] User interface module 1010 may also include associated user interface software executable by device processor 1008 in support of the various user input and output devices discussed above. Separately or in conjunction with each other and other hardware and software elements, the user interface software and user interface devices may support a graphical user interface, a natural user interface, or any other type of user interface.
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[0079] The MEDCOMAP system server 1101 may operate in a networked environment 1100 supporting connections to one or more remote computing devices, such as 1000A and 1000B etc. The network connections depicted in
[0080] It will be appreciated that the network connections shown are illustrative and other means of establishing a communications link between the computers may be used. The existence of any of various network protocols such as TCP/IP, Ethernet, FTP, HTTP and the like, and of various wireless communication technologies such as GSM, CDMA, WiFi, and WiMAX, is presumed, and the various computing devices and the Medication compliance cap described herein may be configured to communicate using any of these network protocols or technologies.
[0081] Although, only two computing devices and one medication compliance cap are illustrated in
[0082] The MEDCOMAP system server 1101, as shown in
[0083] The MEDCOMAP system server 1101 performs a portion or all of the processing steps of medication compliance and drug abuse prevention described herein in response to the processor 1110 executing one or more sequences of one or more instructions 1115 contained in the application memory 1113. The term “computer readable medium” as used herein refers to any medium that participates in providing instructions to the processors for execution. A computer readable medium may take many forms, including but not limited to, non-volatile media, volatile media, and transmission media. Non-volatile media includes, for example, solid state drive, optical, magnetic disks, and magneto-optical disks, such as the hard disk or the removable media drive.
[0084] The Web server 1106 is a system that sends out Web pages containing electronic data files in response to Hypertext Transfer Protocol (HTTP) requests or similar protocol requests from remote browsers (i.e. browsers installed in the computing devices) or in response to similar requests made through a mobile app or mobile application of the present invention installed on a computing device. The web server 1106 can communicate with the mobile app of the present invention and/or with a web browser installed on computing devices 1000A, 1000B to provide the user interface required for the medication compliance and drug abuse prevention system.
[0085] As shown in
[0086] A user may sign-up with the MEDCOMAP system 1100 by providing required details. For this purpose, the user is required to access the user interface, as in step 1708 of
[0087] For the implementation of the medication compliance and drug abuse prevention system of the present invention it is essential that the system has the required information on the medication prescribed. The information on medication includes one or more medication instructions/medication regimen/medication schedule, one or more data on the prescribed medicine comprising commercial name, chemical composition, weight/mass of each medicine/pill/tablet/capsule and total weight/mass of the medicinal substance supplied in a medicine container etc. The system can obtain such information using various options. For example, the prescription can be uploaded/scanned by using the user interface provided on the computing device 1000 and the information on medication can be obtained by the computing device or by the MEDCOMAP system server 1101 from the drug manufacturer and/from any third party database as in step 1712 of
[0088] The user interface provides multiple controls with respect to the functioning of the medication compliance cap as in step 1716 of
[0089] The computing device 1000 and/or the MEDCOMAP system server 1101 are configured to collate the data obtained from each medication compliance cap associated with a user and to present these data along with the medication instructions to the users as in step 1722 of
[0090] For each medication compliance cap which has been attached to a container having a medicinal substance and is associated with a user identity/account, the timing of keeping the seal formed between the cap neck 204 or 304 and the container neck 106 or 112 in a locked state or in an unlocked state can be set as per requirement or as per the medication instructions. The lock/unlock status of all such associated medication compliance caps can be presented on the user interface.
[0091] When the medication compliance cap attached to a container is kept vertically upright (with the container upside down) the medicine or the medicinal substance 800 kept inside the container flows through the passage to the cap internal compartment as shown in
[0092] If a medicine/medicinal substance contained in a container attached to a medication compliance cap/MEDCOMAP cap, such as MEDCOMAP cap 1 (MEDCOMAP caps can be assigned any user preferred name for association with a user identity) is required to be taken by the user between 8 AM and 11 AM once daily as per medication instruction, then the MEDCOMAP cap 1 is configured to remain in an unlocked state during this period (referred to as second specific period of time) as in step 1728 of
[0093] In a preferred embodiment, even during the second specific period of time 8-11 AM in which the MEDCOMAP cap 1 should remain in unlocked state, the control module 214 is configured to let the locking mechanism 206 or 306 to disengage the lock only when a user authentication process is done. The user authentication process can be carried out in several ways—by verifying a user information such as biometric information of the user (or of the user authorized person/caregiver) taken through the computing device 1000 or through the built-in cap user interface 224 of the medication compliance cap, or by verifying a unique code (pre-generated code/password or a one-time password generated by the system) etc. The user authentication step ensures that only the intended user can access the medication contained in medication compliance cap attached container. The user authentication step also allows a user to access the medication in case of an emergency use beyond the specific unlock period.
[0094] A user can be given an audio/visual alert whenever a medication is due as per the medication instruction applicable to the user. For example, the light source 218 shown in
[0095] The medication compliance cap is configured to measure the mass of the medicinal substance contained inside the container in a locked state after every time the medication compliance cap goes through an unlocked state. For example, in case of MEDCOMAP cap 1, it gets locked as in step 1730 after the unlock period of 8-11 AM as in step 1728 of
[0096] Ideally, the difference in mass of the medicinal substance taken before and after an unlock state should be equal to a prescribed mass of medication as determined from one or more medication instruction/information already available with the system. For example, as shown on user interface 1502 in
[0097] If the difference in the mass of this medicinal substance measured before and after this unlock state is found less than the prescribed mass of medication then it is determined that the user has not taken the recommended dose of medicine. If the difference in the mass of this medicinal substance measured before and after this unlock state is found to be more than the prescribed mass of medication then it can be a case of drug abuse. For example, if instead of the prescribed dose of medication 250 mg, the difference in the mass of this medicinal substance measured before and after the unlock state is found to be 500 mg, then necessary alert/preventive actions are required to be taken against drug overuse or abuse. Therefore, as part of such an alert/preventive action, the medication compliance cap is configured to remain in a locked state, as in step 1742 of
[0098]
[0099] In many cases a patient is required to take different medicines at different times of a day in a specific sequence as per their medication schedule/prescription. The MEDCOMAP system can guide a user to take the medication dosage in the required sequence by setting the lock and unlock states of multiple MEDCOMAP caps in a particular order of time periods. For example, if the medicinal substance from MEDCOMAP cap 1 enabled container is required to be taken before the medicinal substance from MEDCOMAP cap 2 enabled container, then the MEDCOMAP cap 2 will get unlocked only after MEDCOMAP cap 1 is unlocked and prescribed mass of medication is taken out of MEDCOMAP cap 1 enabled container.
[0100] The user interface presented on the computing device can provide many other features such as notification on required refills and auto refill option etc.
[0101] In some embodiments, as shown in
[0102] In some embodiments, the MEDCOMAP cap is provided with a gesture detection module 905 as shown in
[0103] In another embodiment, MEDCOMAP system can collaborate with third party services to provide emergency notification/alert to users. With user's approval, the MEDCOMAP system may give third party services access to the user's medication information. One benefit of doing so besides centralizing all health information into the default app of the user's choice is the ability to read and process sensor data for medicinal use. Such third party services (which may be in the form of a mobile app, for example) may analyze the vital physiological parameters of the user on the basis of readings received from wearable sensors used by the user. Additionally, the MEDCOMAP system server 1101 and/or the MEDCOMAP app may also analyze such user health related data received from wearable sensors. If at any instance an emergency medical condition is detected and the user is required to take a medication on emergency basis then the applicable MEDCOMAP cap can be instructed to get unlocked, even if the MEDCOMAP cap is supposed to remain locked at that particular time as per its routine medication schedule, and an emergency visual/audible notification is triggered through the MEDCOMAP cap and/or MEDCOMAP app to prompt the user to take the appropriate medicine immediately. The consumption of another medicinal dose out of a time band or dosage metering in such cases is recorded and accounted for in subsequent measurement of the medicinal substance left in the container by the MEDCOMAP system.
[0104] Users anticipating travel may not want to carry one or more MEDCOMAP cap enabled pill bottles/containers along with them. For such cases, the MEDCOMAP system allows use of a travel mode provided in the MEDCOMAP app. User interface 1602 of
[0105] This written description uses examples to disclose the invention, including the best mode, and also to enable any person skilled in the art to practice the invention, including making and using any devices or systems and performing any incorporated methods. The patentable scope of the invention is defined by the claims, and may include other examples that occur to those skilled in the art. Such other examples are intended to be within the scope of the claims if they include structural elements that do not differ from the literal language of the claims, or if they include equivalent structural elements with insubstantial differences from the literal languages of the claims.
[0106] While the present invention is susceptible to various modifications and alternative user interfaces, a certain illustrated embodiment thereof is shown in the drawings and has been described above in detail. It should be understood, however, that there is no intention to limit the invention to the specific form or forms disclosed, but on the contrary, the intention is to cover all modifications, alternative user interfaces, similar features and equivalents falling within the spirit and scope of the invention, as defined in the appended claims.
[0107] The use of the terms “a” and “an” and “the” and similar referents in the context of describing the invention (especially in the context of the following claims) are to be construed to cover both the singular and the plural, unless otherwise indicated herein or clearly contradicted by context. The terms “comprising,” “having,” “including,” and “containing” are to be construed as open-ended terms (i.e., meaning “including, but not limited to,”) unless otherwise noted. All methods described herein can be performed in any suitable order unless otherwise indicated herein or otherwise clearly contradicted by context. The use of any and all examples, or exemplary language (e.g., “such as”) provided herein, is intended merely to better illuminate embodiments of the invention and does not pose a limitation on the scope of the invention unless otherwise claimed. No language in the specification should be construed as indicating any non-claimed element as essential to the practice of the invention.
[0108] The flowchart is used to describe the steps of the present invention. While the various steps in the flowchart are presented and described sequentially, some or all of the steps may be executed in different orders, may be combined or omitted, and some or all of the steps may be executed in parallel. Further, in one or more of the embodiments of the invention, one or more of the steps described above may be omitted, repeated, and/or performed in a different order. In addition, additional steps, omitted in the flowcharts may be included in performing this method. Accordingly, the specific arrangement of steps shown in