The following specification particularly describes the invention and the manner in which it is to be performed.
This invention relates to a safer and more comprehensive, economical, convenient and digitalised apparatus and method that equips the existing multiple-dose dispenser (Application No. 4321/DEL/2015, the “Existing Dispenser”) with a unique assembly configured to enable additional capabilities including the automated dispensing of multiple-dose pouches containing individual units of homogenous and/or heterogeneous pharmaceutical products which are retained in and/or without manufacturer's packaging, in exact customised quantities and combinations, exactly according to the dose time prescribed by the doctor, with optional automated light and/or sound alerts when the relevant dose pouches are dispensed, provision of a button which when pressed by the user cuts the dispensed pouches and stores and/or communicates the time of cutting with the central systems in real-time. The invention also contains features such as compatibility with IOS and Android phone applications to allow the user to control the device via his/her phone, computer or tablet, additional buttons for allowing dispensed pouches to go back in and reporting emergencies and/or adverse drug reactions. The invention ensures that the user takes his/her doses exactly according to the prescription and tracks and communicates the users adherence or consumption patterns in real-time to improve his/her treatment outcomes.
There are various devices known in the art which dispense medication and track dose adherence, including in real-time. The prior art discloses a number of devices that assist with the dispensation of prescribed medication and record the medical treatment progress. However, the functionality and effectiveness of the medicine/pharmacy management systems in the existing art is limited due to their inability to (i) clearly notify the patient to consume the prescribed medication at the specified time; (ii) alert the patient to charge the device when required; (ii) ensure that medicines are dispensed in the exact quantities and/or combinations as prescribed by the doctor; (iv) allow remote access and control over the features and functions of the device; (v) enable a sufficiently user-friendly and uncomplicated interface; and (vi) account for medicines other than solid pills, thereby excluding from the medicine/pharmacy management system all injections, syrups, powders and other non-oral solids and liquids and/or oral liquids that may be part of a consumer's prescribed treatment. Further, the prior art does not enable the dispensing of pharmaceutical substances other than open pills (i.e. from which the manufacturer's packaging has been removed). In such a situation there is always a risk of that the dispensed medicines have been contaminated in some manner due to exposure to other medicines, moisture or humidity, and have consequently lost some of their efficacy and pharmacological properties. Accordingly, there is a need to obviate the lacunae in the prior art and provide safer, simpler and more user-friendly and efficient tracking and monitoring solutions that enable a convenient, cost-effective and portable system of multiple-dose adherence that is both safe and easy for consumer use.
U.S. Pat. No. 5,582,323A relates to a medication dispenser and monitor which includes a housing containing multiple pill dispensing compartments for dispensing medication to a patient at a desired time. The amount of medication required by the patient per dose is loaded into each individual compartment. The device is programmed to dispense each pill dispensing compartment at a predetermined time corresponding to the time in which the patient is supposed to take the medication. The dispensed medication is received by a tray providing access to the patient. If the patient does not open the tray, audio and visual alarms are activated. In addition, the processor initiates a communication with a central monitoring station through the phone lines to notify the station of the non-compliance. The invention also contacts the emergency personnel through phone lines and initiates two-way hands free communication between the patient and emergency personnel. The invention further includes a pendant transmitter worn by the patient to contact emergency personnel. A limitation of this invention is that it tracks the opening of a tray, which may not necessarily be done only at the time of consumption by the patient and, accordingly, may not be indicative of actual consumption.
US20140052468A1 relates to a medication adherence and monitoring system which also enables dose reminder notifications. The medication adherence system herein includes data-enabled pharmaceutical containers, which provide mechanisms for reminding at dose time, then tracking and communicating valid dose events. The containers have a built-in dose detection algorithm, wherein a dose event is tracked as valid based on sensing that the data-enabled pharmaceutical container is both opened and tilted past a predefined minimum threshold angle simultaneously for a predefined minimum amount of time.
U.S. Pat. No. 7,369,919B2 comprises of a medication tray with containers filled with medicines and a docking station. The medication tray receives prescription data when it receives the medicine containers, data in respect of which is simultaneously downloaded to the docking station. The docking station monitors and reports to third parties, via a network, a patient's compliance with various medication treatment regimens. Medication containers are provided with low-bit tags that provide container presence information to the docking station. The docking station provides visual and/or audio signals regarding prescription data to a patient.
U.S. Pat. No. 5,200,891A relates to a device for monitoring a patient's medication and prompting the patient into certain medication taking schedule and/or certain programming steps and routines. The device has various compartments, each of which stores medication and an electrical signaling system to emit medication alert signals from time to time. There are separate signals to indicate that medication should be taken, the compartment from which the medication should be taken and in what quantity. If a designated compartment is not opened and closed within a predetermined period of time, the electrical signaling system will sound an alarm. If each designated compartment is opened and closed, the take-medication signal and the alarm (if operating) are turned off and the event is recorded for later review.
U.S. Pat. No. 6,085,752A relates to a portable electronic medical device that comprises of separate keys, buttons or touch points on a screen associated with each medication or disease. Each of the keys facilitates access to information related to the associated medication or disease. When the patient presses a key, the device displays a prescription label message concerning the medication contained in the medication compartment associated with the actuated key. Further successive actuations of a same dedicated key will access additional information concerning the medication contained in the medication compartment associated with the actuated key, and this may include information about the particular medical condition that the medication treats. There is a compartment tray of variable capacity and storage system which provides for pre-loading, and pre-labeling of medications, so that when the patient exhausts a supply of medication in one tray, a second pre-loaded and pre-labeled tray can replace the exhausted tray. Opening and closing a medication compartment in the tray signals the tracking function of the device. There are is a specific to indicate that certain scheduled medication doses are due to be taken, and as separate general alert that other actions are required (such as responding to certain patient queries, performance of a particular test, placing the device within the cradle for communication with a remote device, phoning or making an appointment with the health care provider, giving an injection, inhaling an aerosolized medication). Further, there is a graphic display to indicate the patient's progress. The device either automatically presents the supply-to-load messages, or presents the supply-to load messages when the patient presses a dedicated key for a particular medication.
US20130218588A1 includes smart tray monitors and reports to third parties a patient's compliance with various medication treatment regimens. Medication containers are provided with electromagnetic tags that provide various information about medicament contained within a respective container. The smart tray is equipped with a processor and reader that interrogates each respective electromagnetic tag to identify medicament(s) contained within each container. Using the retrieved information, the smart tray provides visual and/or audio signals to a patient to remind the patient when and how much of various medicaments to take. The smart tray also monitors, via the reader, when a medication container is removed. The smart tray can communicate with one or more third parties, such as healthcare providers, pharmacies, and other suppliers of healthcare products and services via a computer network. The smart tray can also communicate with various appliances and can modify medication regimens for particular medicaments in response to data received from various appliances.
A number of limitations present in the prior art are as follows:
An object of the present invention is to ensure that the user takes his/her doses exactly according the prescribed time by automatically dispensing the multi-dose pouches of the relevant dose at the prescribed time and automatically alerting the user with light and/or sound on the body of the apparatus.
Another objective of the present invention is to allow the user to conveniently cut the automatically dispensed dose pouches by pressing a button present on the apparatus so that they can consume the contents of the said pouch.
Another objective of the present invention is to track the time at which the user cuts the dispensed dose pouches using the button present on the apparatus. This information results in the user's adherence or consumption patterns and, when compared with the prescribed dosage times of the user, gives an adherence trend/score card which can be utilised by the user's doctor or healthcare professional to map with the user's treatment progression.
Another objective of the present invention is to communicate the user's non-adherence or non-consumption of each dose in real-time to allow relevant actions to be taken. If a user does not cut the relevant dose pouches at the prescribed time then an alert is sent to his chosen caregivers, family members and/or doctor so specific actions can be taken to ensure that the patient cuts and consumes the dose closest to the prescribed time, thus maintaining complete adherence.
Another objective of the present invention is to allow the users to alert chosen caregivers, family members and/or doctors about any emergencies or adverse drug reactions. A button is provided on the apparatus, which when pressed by the user, sends an alert to the user's chosen persons about the event so that appropriate action can be taken thereafter.
Another objective of the present invention is to allow the user to record when they have consumed the medicines from the dispensed and cut the dose pouch. A button is provided on the apparatus, which when pressed by the user, records the time stamp for the time on which they have consumed the said dose.
Another objective of the present invention is to allow remote access and control of all the features via the linked iOS or Android application. The application allows an individual to dispense pouches for a specific dose or for multiple doses or days, retrieve pouches back into the apparatus incase they have dispensed more than needed and cut the dispensed pouches.
Another objective of the present invention is to automatically share data with the central software regarding current battery life and number of pouches left in the dispenser allowing the system to manage change or recharge of battery and management of dose refills respectively.
Another objective of the present invention is to enable the dispensation of all types of homogenous and/or heterogeneous pharmaceutical products and oral solids such as pills, which are either retained in manufacturer's packaging or otherwise, in the exact quantities and combinations as prescribed. This is a significant aspect of medicine management since dispensing medicines retained in manufacturers' packaging ensures safety, efficacy and pharmacological properties of enveloped substances.
Another objective of the present invention is to allow the user to charge their device via a simple USB port charger.
The following drawings are illustrative of particular embodiments for enabling the system and method of the present invention and are not intended to limit the scope of the invention. The drawings are not to scale (unless so stated) and are intended for use in conjunction with the explanations in the following detailed description.
The present invention relates to a digitalised apparatus and method with refill mechanism for dispensing, tracking and communicating multiple-dose adherence in real-time. The said apparatus comprises of:
a dispensing unit, comprising of motors and rollers, for automatically dispensing and retrieving relevant dose pouches, when needed;
a cutting unit, comprising of motors, a blade with blade holder and a lead screw, for cutting the dispensed dose pouches, once the user presses the relevant button;
an IR sensing unit that senses the eye marks present on the dispensed and cut pouches, thus maintaining a count;
a PCB (printed circuit board) that includes circuitry for multiple communication technologies including GSM, WiFi and Bluetooth;
a battery that provides power for the said actions to be carried out;
a USB charging port that allows for recharging of battery;
a first button with light that allows user to activate the cutting unit;
a second button that allows user to send alert via inbuilt communication technologies in case of emergencies;
a third button that allows user to dispense additional pouches and/or retrieve the dispensed pouches;
a fourth button that allows user to record when they have consumed the medicines from the dispensed and cut dose pouch; and
alert lights for dose reminders and/or low battery.
A schematic representation of a system where the present invention may be implemented is illustrated in
Number | Date | Country | Kind |
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201711026542 | Jul 2017 | IN | national |
Filing Document | Filing Date | Country | Kind |
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PCT/IN2018/050492 | 7/26/2018 | WO | 00 |