CLIAMS:We claim:
1. A system for monitoring the drug adherence by a patient and alerting the non-adherence, comprising of:
a patient-wise digital box, characterized in that the provision for holding and monitoring of the blister wise entire medication regime;
a mobile digital pill box characterized in that the provision for holding and monitoring the pill-wise medication of the patient;
a server system for managing communication in the ecosystem and providing interface for the patient enrollment and management ; and
at least one output communicator device.

2. The system for monitoring the drug adherence and alerting as claimed in claim 1, wherein the patient-wise digital box, comprises of:
- a tray or plate having plurality of slots for holding blister packs, wherein in each slot is characterized with at least one metal strip to detect the presence of the blister pack in the slot,
- an electronic system, comprising of
a PCB sheet below the slot plate,
at least one microprocessor or microcontroller,
a digital/electronic device, characterized to display and communicate the data and events of taking out and putting in of the blister pack, and
- at least two terminals.

3. The system for monitoring the drug adherence and alerting as claimed in claim 1, wherein the digital device in patient-wise digital box, comprises of at least one:
CDMA, or GSM and/or GPRS or 3G or 4G or any such other circuit,
Bluetooth module,
real-time clock,
charging circuit, and
display screen.
4. The system for monitoring the drug adherence and alerting as claimed in claim 1, wherein the patient-wise digital box wherein at least two terminals have been connected to the main electronics by means of the PCB seating below the slot plate.

5. The system for monitoring the drug adherence and alerting as claimed in claim 1, wherein the PCB of the patient-wise digital box, itself has the slots for holding blister packs, with metal strips to detect its presence.

6. The system for monitoring the drug adherence and alerting as claimed in claim 1, wherein the mobile digital pill box comprises:
- means of holding blister pack;
- sets of spring attached plungers,
- PCB, stacked below the plungers,
- a pusher, attached with plungers, to eject pills from blister pack,
- a door, characterized by openings arranged in the same manner of the arrangement of the pills in the blister pack and with provision to hold metallic strip, and
- an electronic processing system.

7. The system for monitoring the drug adherence and alerting as claimed in claim 1 and 6, wherein the mobile digital pill box has top plate with cut-outs to allow for dispensing for pills using fingers and at least one tearable printed circuit, stacked below the blister pack(s).

8. The system for monitoring the drug adherence and alerting as claimed in claim 1 and 6, wherein the electronic processing system of the mobile digital pill box comprises,
at least one microprocessor,
metallic strip on the door
a CDMA, or GSM and/or GPRS or 3G or 4G or any such other circuit,
a bluetooth module,
a real-time clock,
a charging circuit,
a display screen, and
connectors.
9. The system for monitoring the drug adherence and alerting as claimed in claim 1, wherein the mobile digital pill box is to monitor the medication to the patient pill wise.

10. The system for monitoring the drug adherence and alerting as claimed in claim 1, wherein in the digital patient wise box, the presence of blister packs in each slot is detected by measuring conductivity between 2 or more metallic connectors present in the slot.

11. The system for monitoring the drug adherence and alerting as claimed in claim 1, wherein in the mobile digital pill box, appropriate track in the PCB is shorted when the plunger flange touches the PCB when plunger is pressed by the patient or its user to eject the pill from the blister pack and the pill ejection is sensed by the electronics resulting to generate appropriate communication.

12. The system for monitoring the drug adherence and alerting as claimed in claim 1 and 7, wherein in the mobile digital pill box, the pill ejection is sensed by with the torn of the tearable printed circuit, resulting breaking of the conductive track, the same is sensed by the electronics resulting to generate appropriate communication.

13. The system for monitoring the drug adherence and alerting as claimed in claim 1, wherein the mobile digital pill box detects the reloading of a blister by detecting a circuit completion by the metallic strip on the door which shorts the two connectors therein.
14. The system for monitoring the drug adherence and alerting as claimed in claim 1, wherein the electrical circuits of the patient-wise digital box and mobile digital pill box detects the conductivity, generates a signal and transmit via Bluetooth or CDMA or GSM or GPRS or 3G or 4G to the server system for recordation of the generated data on real time basis as per the intended pre-determined medication regime.

15. The system for monitoring the drug adherence and alerting as claimed in claim 1, wherein the electrical circuits of the patient-wise digital box and mobile digital pill box also send operational status, battery level etc. to the stack holders to ensure that device is working properly.

16. The system for monitoring the drug adherence and alerting as claimed in claim 1, wherein the system allows for logging the data in the device for retrieval later or in case when network connectivity is not present and for the data to be send upon the availability of the network.

17. The system for monitoring the drug adherence and alerting as claimed in claim 1, wherein the output communicator device is wirelessly connected with the server system by Bluetooth or CDMA or GSM or GPRS or 3G or 4G circuit etc.

18. The system for monitoring the drug adherence and alerting as claimed in claim 1, wherein the server system transmits the data received on real time basis, as requested or as per pre-determined medication regime schedule to the intended recipient(s).

19. The system for monitoring the drug adherence and alerting as claimed in claim 1, wherein the server system has the input provision to store the patients specific information, data, patients disease, prescribed medication, area / region specific location data and patient-wise digital box and mobile digital pill box allotted to the patients.
20. The system for monitoring the drug adherence and alerting as claimed in claim 1, wherein the server system has the provision for automated process to retrieve the patient specific, registered patients information, doses taken, missed doses, over-doses taken by them, patients’ discharge and reporting frequencies history, assigned health workers performance, their operational efficiencies etc. either directly from the server system or from any networked linked authorized mobile devices by the intended authorized persons, health officers and doctors.

21. The system for monitoring the drug adherence and alerting as claimed in claim 1, wherein the system is used to identify the adherent and non-adherent patients and their locations to enable health officers and doctors and such other intended recipients to take appropriate attention to those who are non-adherent in timely manner.
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FIELD OF THE INVENTION
The present invention generally relates to medical device system. More specifically the invention relates to system for monitoring the drug adherence by a patient and alerting the non-adherence.

BACKGROUND OF THE INVENTION

India bears the burden of various contagious and dangerous diseases like TB, HIV etc. In addition to the large patient population is the problem of mutant variants of the bacteria/viruses/pathogens that are drug resistant. The World Health Organization (WHO) reports in 2013 that in case of TB alone, 3.7% of all newly reported cases are Multi-drug resistant TB (MDR-TB), and 9% of MDR-TB is Extremely Drug Resistant (XDR-TB). In India the MDR-TB burden is estimated at 66,000 people, representing 5% of all new TB cases detected. Treatment for MDR-TB treatment takes at least 24 months as compared to 6 months for regular TB, and the cost is 20 times more expensive. Likewise in cases of other diseases like HIV, hepatitis, cancer etc. treatment requires a long continuous medications.

A major cause for MDR-TB and XDR-TB is non-adherence to medication during the prescribed six to nine month treatment regimen. The bacteria build up immunity to first line of drugs such as Rifampicin and Isoniazid due to interrupted or irregular treatment.

There are several problems that lead to non-compliance from the prescribed treatment regimen. Reasons for Interrupted Treatment Adherence among Patients
1. Behavioral problems
a. Patient does not perceive tangible benefits of taking medication
b. Patient stops taking medication if they do not experience difficulty/pain (symptom abatement)
c. Forgetfulness of the human mind
d. Use of Alcohol and Tobacco
2. Cost of treatment and travel, absence from work
3. Lack of Awareness about the disease and treatment procedures
4. Lack of Access to affordable healthcare providers
5. Ineffective communication between patient and healthcare provider
6. Differences in languages in India

Technology innovations will be able to help patients adhere to the treatment regimen better through reminder systems, patient tracing, awareness generation and reporting mechanisms. The health providers / doctors will be able to oversee a large population of patients with an automated monitoring system, and will find it easier to follow up with defaulters. The problem remains severe for many other chronic diseases as well such as HIV.

Thus, a system is needed to help the Heath care workers (HCW) to monitor patient drug adherence to treatment and take intervention as possible. At present there is no such system commercially available which can help solve the above problem without incurring large expenses.

Also, there are good programs (eg RNTCP) already being run by the government to improve treatment adherence for TB patients using DOTs system but due to practical implications it’s not possible to monitor patients at all time by a Dot worker.

Also, a system is needed which can help HCW to monitor patient and digitize the data faster as compared to manual method as its done right now. Since such programs are highly dependent on the health workers (Dots worker, TBHV etc), it is also needed to ensure that they (HCW) complete their work truthfully, there is a need monitor their activities as well.

Currently this problem is solved by adding measures like checkpoints and production of documentation, surprise visits by administration, training of the HCW and counseling to patients, maintaining treatment cards etc.

There are some devices and system found in the prior art searches for adherence and pill dispensing systems but they are far from adequate to resolve the system wide problem of adherence monitoring.

The Prior art EP0547426A1 talks about a pill box device for pill-wise dispensing from a blister however the mechanism is quite different. This device only dispense pills and does not track which pill has dispensed.

The prior arts US5368187, US7252208, US7431160, US7284661, US7264137 and US5988429 provides for plunger/push button based dispensing of the pills from multiple blisters but they do not provide for or have any automatic detection system. Without automatic detection system, the device will merely be an aid to patient to identify which pill has been taken. But does not help in tracking and automatic regimen monitoring.

While the prior art US7481331 provides for a wall mounted dispenser, which has its limitation in use like cannot be carried by the patient or users other place easily.

Similarly the prior arts US2014288942A1 and CA2855392A1 provides for adherence monitoring systems using different type of devices, but they are either very costly or very cumbersome to use and/or maintain. For example, invention described in US2014288942A1 makes use of accelerometers and optical sensor to monitor the dispensing of the pill, which are substantially costly.

The invention described in CA2855392A1 tracks only the pills and alerts the ecosystem and requires a separate docking system for communication, which make it not only costly to own and use but also not so easy to use.
It would, therefore, be beneficial to be able to provide a complete electronic medical events monitoring system which provides both the blister wise and pill wise tracking throughout medication regime with zero patient burden at an affordable cost. The system should detect both pill-wise and blister-wise adherence for enhancing the quality of tracking throughout medication regime.

The system helps monitoring efficiency and effectiveness of any such disease control programs.

SUMMARY OF THE INVENTION
The present invention provides for the monitoring of the drug adherence by a patient for the management of chronic and/or infectious diseases for example but not limited to TB, HIV etc. and alert the appropriate stakeholder like health care worker(s), patient, relatives, doctor etc. in case of non-adherence of any kind so that they can take appropriate interventional action.

The invention provides for a system for monitoring the drug adherence by a patient and alerting the non-adherence, comprising of a patient-wise digital box, characterized in that the provision for holding and monitoring of the blister wise entire medication regime; a mobile digital pill box characterized in that the provision for holding and monitoring the pill-wise medication of the patient; a server system for managing communication in the ecosystem and providing interface for the patient enrollment and management and at least one output communicator device.

The patient-wise digital box of the invention, comprises of a tray or plate having plurality of slots for holding blister packs, wherein in each slot is characterized with at least one metal strip to detect the presence of the blister pack in the slot, an electronic system. The digital device in patient-wise digital box of the invention, comprises of at least one CDMA, or GSM and/or GPRS or 3G or 4G or any such other circuit, a Bluetooth module, a real-time clock, a charging circuit, and a display screen. While the the mobile digital pill box comprises of a means of holding blister pack; sets of spring attached plungers, PCB or tearable printed circuit, a door, characterized by openings arranged in the same manner of the arrangement of the pills in the blister pack and an electronic processing system.

BRIEF DESCRIPTION OF THE DRAWINGS
Various exemplary embodiments are illustrated in the accompanying figures with the intent that these examples not be restrictive. It will be appreciated that for simplicity and clarity of the illustration, elements shown in the figures referenced below are not necessarily drawn to scale. Also, where considered appropriate, reference numerals may be repeated among the figures to indicate like, corresponding or analogous elements. Of the accompanying figures:
Fig. 1 is a schematic diagram of the patient-wise digital box (Fig 1a) and one of the embodiment of the mobile digital pill box (Fig 1b);
Fig. 1A and Fig. 1B depicts the front and bottom view of one of the embodiment of the mobile digital pill box;
Fig. 1C depicts the various key components of one of the embodiment of the mobile digital pill box;
Fig. 2 depicts the various key components of another embodiment of the mobile digital pill box with tearable printed circuit (6A) and electronic assembly (8);
Fig. 2A depicts one of the schematic representation of the tearable printed circuit (6A);
Fig. 2B and Fig. 2C depicts the front and bottom view of the other embodiment of the mobile digital pill box with tearable printed circuit;
Fig. 3A and Fig. 3B depicts the various key components of the patient –wise digital box showing the screen for interaction and arrangement of electronic assembly (11D), connectors (11A), PCB (11C), slots for blisters (11B) etc.

DESCRIPTION OF THE INVENTION
The description that follows provides various details of exemplary embodiments. However, this description is not intended to limit the scope of the claims but instead to explain various principles of the invention and the manner of practicing it.

The system of the present invention provides for the monitoring of the drug adherence by a patient for the management of chronic diseases for example but not limited to TB, HIV etc. and alert the appropriate stakeholder (HCW (health care worker(s)), patient, relatives, doctor etc.) in case of non-adherence of any kind so that they can take appropriate interventional action.

In an embodiment the present invention provides for a system for monitoring the drug adherence by a patient and alerting the non-adherence, comprising of at least one patient-wise digital box (ref. Fig. 1a), with the provision for holding and monitoring of the blister wise entire medication regime; a mobile digital pill box for holding and monitoring the pill-wise medication of the patient (Fig. 1a or Fig. 2); a server system (Fig. 1c) connected with more than one communicator device(s) (Fig 1d).

In an embodiment of the invention, the patient-wise digital box comprises of a tray or plate having plurality of slots for holding blister packs, wherein in each slot is characterized with at least one metal strip to detect the presence of the blister pack in the slot, an electronic system, comprising of a PCB sheet below the slot plate, at least one microprocessor or microcontroller, a digital device, characterized to display and communicate the data and events of taking out and putting in of the blister pack, and at least two terminals, which have been connected to the main electronics by means of the PCB seating below the slot plate (refer Fig. 1a & 4B).

In another embodiment of patient wise digital box, the PCB itself will have the slots for holding blister packs, with metal strips to detect its presence and the tray would not be needed (refer Fig. 4A).

The digital device/electronic assembly (11D) in patient-wise digital box, comprises of at least one CDMA, or GSM and/or GPRS or 3G or 4G or any such other circuit, a bluetooth module, a real-time clock, a charging circuit and a display screen (11).

The patient-wise digital box can track the taking out and putting in of any blister in it by means of checking the electrical conductivity between two terminals in the slot provided for the blister by making use of the conductivity of the blister material. The system can track that a specific blister has been taken out and then put back there by ensuring that one pack has been used by the patient and replace back. The box does not re-count the same blister if taken out again. The two terminals have been connected to the main electronics by means of the PCB seating below the slot plate.

In an embodiment of the invention, the mobile digital pill wise box of the present invention means of holding blister packs (a single (or multitude) (10), sets of spring attached plungers (1), PCB (6) stacked below the plungers (1), a pusher, attached with plungers (1), to eject pills from blister pack, a door (2), characterized by openings (12) arranged in the same manner of the arrangement of the pills in the blister pack and with provision to hold metallic strip, and an electronic processing system/assembly (8) (refer Fig 1A, 1B and 1C). The electronic processing system/assembly (8) of the mobile digital pill box comprises, at least one microprocessor, a metallic strip on the door, at least one of the CDMA, or GSM and/or GPRS or 3G or 4G or any such other circuit, a bluetooth module, a real-time clock, a charging circuit, a display screen, and connectors.

In one of the embodiment of the invention, in the mobile digital pill wise box there are a set of spring attached plungers arranged above each pill of the blister (10) and there is a PCB (6) stacked below the plunger which is shorted when the plunger flange touches the PCB when plunger is pressed.
When the plunger is pushed by the user to eject the pill from blister and it in turn touch the appropriate track in PCB, thereby shorting it and completing a circuit which is detected/sensed by the electronics system. The blister can be reloaded in from the door at the back side of the device. The door(2) has number of openings (12) arranged in the same manner the arrangement of the pills in the blister pack to allow for pills to come out while keeping the entire blister in its place.

The springs attached to the plunger brings the plunger back in outward (un-pressed) state when left by the user. The mobile digital pill box (ref. Fig 1b or Fig 2) can also detect the reloading of a blister by detecting a circuit completion by a suitable metallic strip on the door which shorts the two connectors in the pill box.

Both the boxes comprise of electronics which may contain many components for example but not limited to a micro-controller/microprocessor, at least one CDMA, or GSM and/or GPRS or 3G or 4G or any such other circuit, a bluetooth module, real-time clock, battery, charging circuit, a mobile phone, screen etc. for the purpose of detecting the change in the electrical connectivity in the PCB (between the slot terminals in digital box and plunger PCB in pill box). The electrical circuit detects the conductivity generates a signal via Bluetooth, CDMA or GSM or GPRS or 3G or 4G to the server system (refer Fig. 1c) for recordation of the generated data on real time basis as per the intended pre-determined medication regime and for its storage and simultaneously to the mobile of the intended recipient who could be the patient, health care provider/doctor etc. The signal are generated as per some rules based on the required pre-determined medication regime. Signal also contains data like the number or pill/blister taken out, its time stamp, patent information and event info for example “Pill 2 missed by patient XXX” or “pill 4 taken by patient YYY on 25th Feb, 10 AM.”

The message is sent via Bluetooth or CDMA or GSM or GPRS or 3G or 4G to the intended receiver where they can read the same via a SMS or using an app designed for the same at its communication device (Fig. 1d). The electronic system may also log the information sent/to be sent as local copy and send it later if the network or recipient device is unavailable. The system also consists of an OTP/button based input method to validate/authorize the user/operator.

In yet another embodiment and variant of the invention, the mobile digital pill box comprises of at least one blister pack case with electronics processing system/assembly (8) enclosed, characterized with at least one tearable printed circuit characterized with the customized for the specific disease (refer Fig. 2A), and blister pack (10) (Refer Fig. 2, Fig 2B and Fig. 2C). In this embodiment, the blister pack (10) is loaded on to the disease specific customized tearable printed circuit (6A) (refer. Fig. 2A). The customized tearable printed circuit is connected to the electronics of the box by getting sandwiched between the flap/cover/door (2) and the connectors (13) provided in the digital mobile pill box. Once the flap/cover/door (2) is closed and latched to arrest the customized tearable printed circuit (6A) and the blister pack (10) and established electrical connections with the rest of the electronics (8). When the pill is pushed out by the user, the pill also tears the tearable printed circuit and the circuit breakage is detected by the electronics. Once all the pills have been torn out, the tearable printed circuit shall be replaced with a new one along with a new blister pack refill.

The tearable printed circuit of this embodiment of the invention can be made by any tearable material including paper, thin plastic, OHP, or flexible but tearable PCB materials and have at least one printed circuit (6A(c)) on it (Ref. Figure 2A). This tearable printed circuit also have perforations and cuts (6A(a)) to guide and control the tear within the required zone only. The tearable circuit may be complete sheet with perforations around the pill locations as shown in Figure 2A, or it can have additional cuts to leave material only needed for the conductive track. This tearable printed circuit also detects ejection on each pill from the blister pack.

In yet another embodiment of the invention, the system consists of a web-server (Fig. 1c) where the patients are registered, and allotted the said devices. The web server also serves as data repository of all the patients and gateway of sending communication to various stakeholders at their registered/connected communication devices (Fig. 1d) (Refer Fig 1 for the entire system). The web-server can be used for managing all the patient information and their discharge, reporting etc. It can be used to track adherence and operational efficiency of the patient and HCW respectively to be used for incentivizing good work and adherence.

The system can monitor the entire medication of the patient and inform the appropriate stakeholders including the patient in case of any appropriate dose taken, missed dose, over-dose and wrong pills taken. The system can work automatically without requiring any input by the users; they just use device as they would normally do. The system of the present invention also enables HCW/doctors to monitor if the patient has taken medicine on time remotely and take immediate action in case of missed dose/over dose etc.

The system of the present invention also serves as input mechanism to digitize patient data and medication activity in the web server saving time and extra efforts to do the same later on thus improving upon the latency that exists in the current system. The system of the present invention helps the authority to track if the health care worker is doing his/her job properly for example is doing timely visits to the patient by asking him to enter a OTP in pill box each time he visits the patient’s house.

The system of the present invention helps in identify the adherent and non-adherent patients so that appropriate attention can be given to those who are non-adherent more efficiently. The system of the present invention also helps track the location of the patients to identify data like high disease concentration area, increase in spread etc.

The system of the present invention can also be used as an incentive platform for the adherent patients and good health workers because of its ability to track their activities.