WO2022219653A1

WO2022219653A1 - A device for assisting in compliance to prescription

Info

Publication number: WO2022219653A1
Application number: PCT/IN2022/050365
Authority: WO
Inventors: Anusha Kudlur VENKATESH; Mahesh Sundaresha Belavadi
Original assignee: Venkatesh Anusha Kudlur
Priority date: 2021-04-16
Filing date: 2022-04-16
Publication date: 2022-10-20

Abstract

Disclosed is a device (100) configured for alerting a user that a medicine is to be consumed at that time and also sensing that the medicine has been consumed. The sensor element on which the sensing is based is a conductive polymer composite (300). In one embodiment, a blister pack containing the prescribed tablet is inserted and secured in the device. When the device (100) issues an alarm that the tablet is to be consumed and the user applies a pressure on the composite and thereby on the blister pack to remove the tablet, the change in resistance is measured which is indicative of the event that the tablet has been removed and consumed. An exemplary embodiment (600) of inhaler being monitored is also disclosed. The data on the times, medicine and that it has been consumed may be stored. In case of non-compliance, stakeholders may be alerted.

Description

A DEVICE FOR ASSISTING IN COMPLIANCE TO PRESCRIPTION

TECHNICAL FIELD:

[001] The present invention relates to the field of healthcare. It particularly relates to devices for assisting a person in complying with a medical prescription.

BACKGROUND:

[002] When a person is indisposed, a physician may prescribe various medicines. The prescription may also contain details such as the number or quantity of each medicine, the time of day at which each has to be consumed, whether it has to be consumed before or after consuming food, and so on. The prescribed medicine may be in the form of tablets, capsules, syrups, and medicines to be inhaled through the use of an inhaler, and so on.

[003] It is well known and well researched that a medical outcome depends significantly on compliance to the prescription, apart from other factors. However, it is also well known that patients often miss consuming the medicine prescribed due to various reasons such as, being distracted, being forgetful, the medicine not being accessible at the prescribed time, and so on. Especially when a support system such as a spouse, other family members, or a caregiver does not exist, the possibility of a medicine not being consumed as prescribed increases, affecting the prognosis and medical outcome negatively.

[004] In many places around the world the population is ageing considerably. An ageing patient is more likely to miss consuming the prescribed medicine at the prescribed time because of short term memory loss, fatigue, or distraction. Further, the impact of missing one or more doses of the medicine might be more severe with the age of the person. At the same time, it is also possible that a person needs regular medication but is very busy at work and might forget to take the medicine. Even in such cases, missing the medicines regularly has a negative impact on the medical outcomes. These are only a few of the conditions in which there are possibilities of noncompliance to a prescription. There are many other situations, in which medicines may be missed often. Thus, there has been a need for assisting a person in consuming medicines at the prescribed time.

[005] An exemplary prior art method used is setting an alarm on a mobile. However, such a method may be called an open loop system because the alarm only reminds the person that medicine should be consumed but it has no means of recording or confirming that the medicine has actually been consumed.

[006] There are also prior art electronic devices that not only remind a person, audio-visually, that a particular medicine has to be consumed at the prescribed time but also sense whether the medicine has been consumed. One such exemplary prior art device, disclosed in the granted US patent numbered US10838098B2, assigned to Popit Oy, senses the sound made when a tablet has been removed out of a blister pack of a tablet. However, such a device may be unreliable in a noisy environment.

[007] The granted US patent numbered US7126879B2 discloses a special blister package that has a frangible layer containing conductive traces on it. The traces are broken while removing a dose, which is a detectable event. This is used to sense that a dose has been removed. All medicaments may not be available in this type of packing and hence may not be useful for doses in normal blister packing.

[008] Another exemplary prior art device is configured to accept a specially devised blister pack. Such a blister pack has conductive tracks running on its surface as described above. When a tablet is removed from the blister pack, the track is broken causing an electrical open circuit. The open circuit can be sensed and is an indicator that a tablet has been taken out of the blister pack. However, such a method increases the cost of the packaging of the blister pack itself, making the medicine more expensive. Thus, it may be desirable to have a device and a system that does not have this disadvantage. SUMMARY OF THU INVENTION:

[009] Thus, there has been a long-standing requirement for a device that overcomes at least one of the problems in the state of the art devices. Thus, the present disclosure is oriented towards a device that overcomes at least one of the problems in the state of the art devices.

[0010] Disclosed is a monitoring device configured to receive a strip of tablets or capsules packed in a blister pack. The tablets or capsules may be referred to as a medicament. However, hereinafter, reference is made only to a tablet in the description for the sake of clarity and conciseness, and it is to be assumed that what is described applies equally to a capsule, in other words a medicament, unless stated otherwise. The blister pack is received such that the plane side of the blister pack, that is, the side other than where the blisters are formed, rests on or is proximal to a planar sensor device. The planar sensor device is configured to undergo a change in its electrical resistance, measured between two of its lead wires, when a pressure is applied on the blister pack by a user in order to remove a tablet from it. An electronic circuit is configured to measure this change in its electrical resistance as a proxy for a tablet having been removed from the blister pack.

[0011] Also disclosed is the planar sensor device. The sensor strip is configured to undergo a change in resistance, as measured between its two lead wires, of a couple of orders of magnitude or more - a few hundreds of kilo Ohms or more to tens or hundreds of Ohms, for example.

[0012] Disclosed are also various embodiments of a sensor strips used in the disclosed device.

[0013] Embodiments of the disclosed monitoring device are also configured to for displaying whether the removal of a tablet has been recorded or not. They may also be configured to have user input means for a user to enter the details of the prescription for a particular tablet. That is, at what times of the day should the tablet be consumed and how many.

[0014] Embodiments of the disclosed monitoring device may also have memory capability to store the instances of the tablet being removed and hence consumed from each device. The disclosed monitoring device is also configured to store the temporal details of the instances. Embodiments may also have communication capabilities, wired or otherwise, to receive inputs, send data about the consumption of the tablet and the time of consumption and so on to for storage elsewhere, a server for example.

[0015] Disclosed is a planar sensor device for sensing a pressure applied on a surface of the planar sensor device wherein the pressure applied has at least a component of pressure perpendicular to the plane of the sensor, the planar sensor device characterised by a planar conductive polymer disposed between two foils of a conductive material, the two foils being disposed between two planar insulating sheets, and the conductive foils being electrically connected to a lead wire each for measuring an electrical resistance between the two lead wires and wherein a resistance between the two lead wires is a function of the component of the pressure applied perpendicular to the plane of the planar sensor device.

[0016] Also disclosed is a monitoring device configured for detecting an occurrence of an event, the monitoring device characterised by a resistance measurement module configured for measuring an electrical resistance, a signal analysis module configured for registering when the event has occurred, based on the electrical resistance measured, and a memory module comprising a digital memory configured for storing the instances of occurrence of the event, and temporal details associated with the occurrence of the event.

BRIEF DESCRIPTION OF THE FTGTTRES:

[0017] The disclosed device will be described and explained with additional specificity and detail with the accompanying figures in which: [0018] Figure 1 shows the plan view of an embodiment of the disclosed device while in use;

[0019] Figures 2A and 2B shows the elevation views of an embodiment of the disclosed device; [0020] Figure 3 shows the construction of the sensor strip used in at least embodiments of the disclosed device;

[0021] Figure 4 shows the essential functional modules of an implementation of an electronic circuit of an embodiment of the disclosed device;

[0022] Figure 5 shows an implementation of one embodiment of the present disclosure configured for detecting the removal of tablets from more than one blister pack;

[0023] Figure 6 shows an embodiment off the present disclosure configured for detecting the use off an inhaler by user, and

[0024] Figure 7 shows the disclosed system for assisting in prescription compliance.

[0025] Further, persons skilled in the art to which this disclosure belongs will appreciate that elements in the figures are illustrated for simplicity and may not have necessarily been drawn to scale. Furthermore, in terms of the construction of the device, one or more components of the device may have been represented in the figures by conventional symbols, and the figures may show only those specific details that are pertinent to understanding the embodiments of the present disclosure so as not to obscure the figures with details that will be readily apparent to those of ordinary skill in the art having the benefit of the description herein.

DETAILED DESCRIPTION OF THE EXEMPLARY EMBODIMENTS: [0026] For the purpose of promoting an understanding of the principles of the disclosure, reference will now be made to the embodiment illustrated in the figures and specific language will be used to describe them. It will nevertheless be understood that no limitation of the scope of the disclosure is thereby intended. Such alterations and further modifications to the disclosure, and such further applications of the principles of the disclosure as described herein being contemplated as would normally occur to one skilled in the art to which the disclosure relates are deemed to be a part of this disclosure.

[0027] It will be understood by those skilled in the art that the foregoing general description and the following detailed description are exemplary and explanatory of the disclosure and are not intended to be restrictive thereof.

[0028] The terms "comprises", "comprising", or any other variations thereof, are intended to cover a non-exclusive inclusion, such that a process or method that comprises a list of steps does not include only those steps but may include other steps not expressly listed or inherent to such a process or a method. Similarly, one or more devices or sub-systems or elements or structures or components preceded by "comprises... a" does not, without more constraints, preclude the existence of other devices, other sub-systems, other elements, other structures, other components, additional devices, additional sub-systems, additional elements, additional structures, or additional components. Appearances of the phrase “in an embodiment”, “in another embodiment” and similar language throughout this specification may, but do not necessarily, all refer to the same embodiment.

[0029] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure belongs. The device, system, methods, and examples provided herein are illustrative only and not intended to be limiting.

[0030] Embodiments of the present disclosure will be described below in detail with reference to the accompanying figures. [0031] Embodiments of the present disclosure disclose a device configured, among other things, to sense when a tablet has been removed out of a blister pack. With reference to Figure 1 this aspect of the disclosed device will now be described. Figure 1 shows a blister pack 110 disposed in the disclosed device 100. The means as shown by reference numerals 105-1 and 105-2 are configured for holding the blister pack 110 in place. These means could be a piercing pin or a pressure applying screw holding the blister pack 110 in place. The reference numeral 115 shows a strip of a conductive polymer composite that will be described further below. The module at the right of the device 100 is referred to as the circuit block 120. The shaded grey circles inside the blister pack 110 represent tablets in blisters of the blister pack 110.

[0032] Figure 2A shows a blister pack placed in the device 200. Figure 2B shows the blister pack 210 disposed in the disclosed device 200 and held in position therein. The means as shown by reference numerals 205-1 and 205-2 are configured for holding the blister pack 210 in place. These means could be a piercing pin or a pressure applying screw holding the blister pack 210 in place. The reference numeral 215 illustrates a strip of conductive polymer composite that will be described further below. The module at the right of the device 200 is referred to as the circuit block 220. The shaded grey rectangles inside 210 represent tablets in blisters of the blister pack 210. It has to be noted that for the purpose of understanding, the circuit block 220 is shown at the right. However, it is a trivial problem to find alternative positions for the circuit block 220 in various implementations.

[0033] With reference to Figure 3 the structure and functioning of the conductive polymer composite 300 will now be described. The composite comprises two insulating layers 325-1 and 325-2. These two layers 325-1, 325-2 sandwich two copper layers 330-1, 330-2. These two copper layers 330-1, 330-2 in turn sandwich a single layer 335 of a conductive polymer. One example of an electrically conductive polymer in tape form is tape MSG6060F manufactured by 3M™. Such polymers are intrinsically conductive unlike some earlier generation of products that were insulating polymers compounded with conductive fillers such as carbon. The two copper layers 330-1 and 330-2 may be connected electrically to two lead wires 340-1 and 340-2. If the resistance between the two lead wires 340- 1, 340-2, is measured, when the composite is not under any stress or is not bent or deformed in any way, the resistance measured will be high. This measured resistance might be in the range of a few hundred mega Ohms, for example. However, if a pressure is applied in a direction perpendicular to the plane of the composite from either or both sides, the resistance measured, will be considerably lower than the initial measurement - a few Ohms or a few tens of Ohms, for example. This difference or change may be used as a measure of the pressure being applied on the composite.

[0034] It may be noted here that even though in the description above, copper has been mentioned, any other suitable conductive materials such as silver, aluminium, or their alloys may also be used. Often, electrical grade copper is a good choice because of its electrical and mechanical properties. However, a person skilled in the art, in possession of the teachings of the present disclosure may choose other suitable materials depending on the preferred electrical and mechanical properties. Such an alloy may be made of one or more of the metals mentioned above with or without other materials such as tin, zinc, and beryllium to obtain preferred conductivity and other properties such as solderability, formability and ability to withstand repetitive bending, for example.

[0035] The conductive polymer composites may be produced in bulk and in standard large sizes, as a roll for example, and then cut to suitable sizes based on requirement.

[0036] It may be noted that the conductive polymer composite structure 300 may be modified to suit different applications or different use conditions or both. These modifications may include, but not limited to, adding additional layers of insulation at the top and the bottom layers of Figure 3. The modifications may also include changes in the thickness of each layer. It may be conceivable that instead of two layers of copper only one is used. It may also include the addition of reinforcing layers to strengthen the composite so that it is not easily pliable and hence a minimum amount of pressure is applied while removing the tablet from the blister pack. All such modifications are considered to be within the ambit of the concepts of this disclosure. With reference to Figures 1, 2A, 2B, and 3, if a tablet in the blister pack is taken out by applying pressure on the composite and through it on the blister pack, and the resistance between the two lead wires 340-land 340- 2, is measured during the process, it will indicate a change in resistance of several orders of magnitude which is equivalent to the information that the tablet has been removed from the blister pack. This is the principle on which the disclosed device operates.

[0037] The overall functioning of the circuit 400 of the disclosed device will now be described with reference to Figure 4. The circuit 400 comprises a power management module 445. This module manages all the power requirements of the disclosed device 100. The resistance measurement module 450 is configured for monitoring the resistance between the two leads 340-1 and 340-2 of Figure 3. The signal analysis module 455 is configured for analysing the signal output by the resistance measurement module 450. The data generated by the signal analysis module 455 may be stored in the memory module 460 along with the temporal details associated with the data. Herein, the term “temporal details” means the details relating to time, that is, they year, month, date, day of the week and time. The time could be either in 12 hour format or 24 hour format. The alarm manager module 465 is configured for issuing alarms to the user. The data about when to issue the alarm and what medicines should the user consume at each alarm may also be stored in the memory module 460. The alarm managers module 465 issues alarms using audio means or visual means or both. For example, a light emitting diode (LED), or an LED display screen may glow attracting the attention of the user. Simultaneously a beeper may provide an audio alarm. Various alternatives to this may be envisaged by a person of ordinary skill in the art, such as a computer generated voice message informing the user that one or more medicines are to be consumed and what those medicines are. All these functions are managed by the alarm manager module 465. The circuit 400 further comprises communication module 470.

[0038] The communication module 470 is configured for receiving the medical prescription data from a server for example. The communication between this server and the circuit 400 may be effected using any one of the known means of communication such as Wi-Fi, wired communication, and so on, for example.

[0039] Once the alarm is issued, the resistance measurement module 450 may start monitoring the resistance between the lead wires 340-1 and 340-2. When the user removes a tablet from the blister pack attached to the device 100, the signal analysis module 455 registers it as a tablet having been taken and then stores that information in the memory module 460. The communication module may store this data locally in the memory module 460 or communicate it to the server or both. Additionally, data such as time at which the tablet was removed, quantity removed, the date and such other details as may be required may also be stored for later analysis and review. [0040] Additional features and facilities such as alerting caregivers and family members when the tablet is not removed from the blister pack in spite of a predefined number of warnings by the device may also be incorporated into the disclosed device. Such other features, facilities, and functionalities may be incorporated into the device is well known in the related arts. [0041] Even though not described in detail in this disclosure, the electronic circuit block 120 may also have a keyboard, touch sensitive displays, one or more LEDs for indications, switches, and push buttons as user interface for using this device conveniently. For example, if the tablet is removed from the blister pack but the device fails to record the event, the user may have the ability to record the removal by a push button. Various other modifications to this interface may be thought of by a person of ordinary skill in the art. One such other modification may be a voice recognition system to enable a user to input such an information.

[0042] Even though in the description hitherto, provision for affixing only one blister pack to a device has been described, it is possible to configure the device 100 in such a way that the circuit 400 is able to monitor more than one blister pack that may be attached to the device 100. This may enable issuing warnings about more than one medicine at any given time and also monitoring the consumption of each of those medicines. This can also be so configured adds to occupy the least amount of space and most convenient to use.

[0043] One implementation of a device 500 configured for sensing tablets being removed from more than one blister pack is shown in Figure 5, wherein, in the reference numerals, the letter ‘n’ indicates the number of strips, ‘n’ being greater than one. However, it may be noted that the circuit block 520 does not contain n number of circuit blocks such as 120 but the same circuit as shown in circuit block 120 of Figure 1 may be configured for working with multiple blister packs. What would be needed, for example, is a multiplexer to which multiple pairs of leads 340- 1, 340-2 from ‘n’ conductive polymer composites are connected and the resistance measurement module 450 of Figure 4 monitors the resistances of all the blister packs repeatedly in a serial fashion. A person of ordinary skill in the art will be able to implement this without much difficulty.

[0044] Further, even though the embodiment described hitherto was said to have only one type of tablets stored in a blister pack, it is conceivable that the same principles that enable the described embodiment may also be used for other kind of containers and other kind of medicines. For example, the conductive polymer composite may be attached to sense whether an inhaler’s plunger has been pressed. With reference to figure 6, an inhaler 675 is shown in hatched silhouette. The conductive polymer composite strip 615 is attached and communicatively connected to the circuit block 620. Support element 680 supports the inhaler 675. Whenever a user presses the conductive polymer composite piece 615 to operate the inhaler, the circuit block 620 monitoring the resistance of the conductive polymer composite 615 registers a change and records this in the manner already described with reference to the embodiment described with reference to Figure 4.

[0045] The disclosed system 700, configured for assisting in prescription compliance is now described with reference to figure 7. The system 700 comprises the disclosed device 100, for example, communicatively coupled to a communication network 790. A computing device 795 is also communicatively coupled to the communication network 790. A user device 785 is also communicatively coupled to the communication network 790. Prescription details such as the name of the medicine, time at which it has to be consumed, the dosage, and such, may be stored in the computing device 795. The same information may also be stored in the device 100 as well. The device 100 and the user device 785 associated with the user who has to comply with the prescription may be connected to each other either directly or through the communication network. One means of direct interconnection between device 100 and user device 785 may be Bluetooth, for example. The system may also include a user device 797, used by a doctor for example, on which a doctor may enter the prescription details. The user device 797 associated with the doctor communicates with the computing device 795 through the communication network 790. In one exemplary embodiment of the system, a doctor using the user device 797 enters the prescription on the user device 797. This information is conveyed to the computing device 795 through the communication network 790. The computing device 795 in turn communicates with the device 100 through the communication network 790 and stores the prescription data and sets the alarms for the user to follow. As described earlier, the disclosed device 100 may also communicate with the user device 785 associated with the user who has to comply with the prescription. [0046] The method of sensing on which the device and system hitherto described is based, is now described. The method comprises using a conductive polymer composite as shown in Figure 3. Further, the method comprises measuring a resistance between the two lead wires 340-1 and 340-2 of Figure 3 either continuously or during predefined intervals of time. The predefined period could be a length of time after a predefined time at which the tablet is to be consumed by a user of the device 100 using the method being described herein. It also includes disposing a blister pack 110 of tablets on the surface of the conductive polymer and holding them together with the aid of a holding means such as pins 205-1 and 205-2 of Figure 2 for example. When a tablet is removed from the blister pack 110 disposed on the conductive polymer composite 115, the resistance being measured will decrease by several orders of magnitude. This measured decrease is further used as a representation of the event that the tablet has been consumed. The same method may be used for sensing the opening the cap of a bottle of syrup or tablets, pressing of an inhaler and so on. A person skilled in the art may come with many such applications and all such embodiments are within the scope of this disclosure.

[0047] A person of ordinary skill in the art will be able to envisage variants using the same principles as described hitherto and create devices configured for issuing alarms and monitoring the consumption of other kinds of medicines in other kinds of packaging also.

[0048] While specific language has been used to describe the disclosure, any limitations arising on account of the same are not intended. As would be apparent to a person skilled in the art, various working modifications may be made to the devices, method, and system in order to implement the inventive concept as taught herein.

[0049] The figures and the foregoing description give examples of embodiments. Those skilled in the art will appreciate that one or more of the described elements may well be combined into a single functional element. Alternatively, certain elements may be split into multiple functional elements. Elements from one embodiment may be added to another embodiment. For example, orders of processes described herein may be changed and are not limited to the manner described herein. Moreover, the actions of any flow diagram need not be implemented in the order shown; nor do all the acts necessarily need to be performed. Also, those acts that are not dependent on other acts may be performed in parallel with the other acts. The scope of embodiments is by no means limited by these specific examples. Numerous variations, whether explicitly given in the specification or not, such as differences in structure, dimension, and use of material, are possible.

Claims

We claim

1. A planar sensor device (300) for sensing a pressure applied on a surface of the planar sensor device (300) wherein the pressure applied has at least a component of pressure perpendicular to the plane of the sensor, the planar sensor device (300) characterised by: a planar conductive polymer (335) disposed between two conductive foils (330-1, 330-2) of a conductive material; the two conductive foils (330-1, 330-2) being disposed between two planar insulating sheets (325-1, 325-2); and the conductive foils (330-1, 330-2) being electrically connected to a lead wire each (340-1, 340-2) for measuring an electrical resistance between the conductive foils (330-1, 330-2) and wherein a resistance between the two conductive foils (330-1, 330-2) is a function of the perpendicular component of the pressure applied.

2. The planar sensor device (300) as claimed in claim lwherein the planar conductive polymer (335) is made of intrinsically conductive polymer.

3. The planar sensor device (300) as claimed in claim 1 wherein the material of the conductive foils (330-1, 330-2) is selected from a group of metals comprising, but not one limited to, silver, copper, aluminium, and alloys of one or more of them with or without other metals.

4. A monitoring device (400) configured for detecting an occurrence of an event using the planar sensor device (300) of claim 1, characterised by: a resistance measurement module (450) configured for measuring an electrical resistance; signal analysis module (455) configured for registering when the event has occurred based on the electrical resistance measured; and a memory module (460) comprising a digital memory configured for storing the instances of occurrence of the event, and temporal details associated with the occurrence of the event.

5. The monitoring device (400) as claimed in claim 4 wherein the electrical resistance is measured between the lead wires (340-1, 340-2) of the planar sensor device (300) as claimed in claim 1.

6 The monitoring device (400) as claimed in claim 5 configured for receiving a blister pack (110) for recording instances of each unit of a medicament being removed from the blister pack (110) wherein the unit of medicament is removed by applying pressure on the blister pack (110).

7. The monitoring device (400) as claimed in claim 5 wherein the planar sensor device (300) is disposed so as to sense instances of operation of an inhaler.

8 The monitoring device(400) as claimed in claim 5 wherein the planar sensor device (300) is disposed so as to sense to sense instances of a rotary cap of a liquid medicament being turned by disposing the .

9 The Monitoring device (400) as claimed in claim 5 comprising a user interface comprising a display and input device configured for, accepting prescription data and storing the prescription data in the memory module (460) and alerting a user when a dose of the medicament is due.

10 The monitoring device (400) as claimed in claim 5 comprising a communication module (470) configured for communicating one or more of the prescription data, the occurrences of the event, and the temporal data associated with each event to a central storage.