GB2534004A

GB2534004A - A medication adherence monitor

Info

Publication number: GB2534004A
Application number: GB1519091.1A
Authority: GB
Inventors: Graham Palmer Charles
Original assignee: Individual
Current assignee: Individual
Priority date: 2014-10-29
Filing date: 2015-10-28
Publication date: 2016-07-13
Also published as: GB201519091D0; GB201419216D0

Abstract

A monitor into which a standard medication blister package 209 may be placed, the tray comprising a plurality of cells containing medication, the monitor comprising sensors 602 that detect which cells in the medication tray have been opened, and a means of transmitting this information wirelessly to remote servers, via an intermediate communication gateway. The monitor also has a display screen upon which messages relating to the use of the medication are displayed. The means of detecting opened cells include infrared proximity sensors, capacitive sensors, inductive sensors, mechanical switches and paired optical emitters and detectors. The apparatus allows medical professionals to check if medication is being taken as prescribed.

Description

Intellectual Property Office Application No. GII1519091.1 RTM Date:21 April 2016 The following terms are registered trade marks and should be read as such wherever they occur in this document: Bluetooth, ZigBee, Sigfox, LoRa, Weightless.

Intellectual Property Office is an operating name of the Patent Office www.gov.uk/ipo

I

A Medication Adherence Monitor

BACKGROUND OF THE INVENTION

1) Field of the Invention

The present invention relates to the remote monitoring of removal of material from packaging, and specifically when the material is medication and the packaging is medication packaging the present invention relates to the remote monitoring of medication adherence.

2) Description of the Related Art

Poor compliance with medication is a huge problem for patients, their families and carers, and for health services. Up to 50% of medication is not taken as prescribed, and up to 10% of hospital admissions are attributed to medication being taken incorrectly. A variety of solutions exist to help patients improve their adherence. Some make it easier for patients to remember which medication to take at which time, by packaging medication in time-ofday and day-of-week packaging. Others present patients with reminders such as flashing lights attached to the medication packaging. Others present include mechanical means to present the patients with the pills that are to be taken, at the time at which they should be taken. These solutions provide no feedback to remotely located healthcare professionals or to carers that lets them know that the medication has been taken, or that lets them take action if it has not been. It is well known that patient-reported adherence data is often inaccurate and of little use to determine the actual consumption of medication, or to permit interventions to improve the patient's medication adherence. Other techniques involve placing medication in specialist packaging which monitors when medication is taken and notifies remotely located healthcare professionals or carers but such specialist packaging is expensive or difficult to use.

In some cases, particularly when the patient has multiple medicines and difficulty in managing to take these various medicines at the correct time, the multiple medicines are placed in trays which are often called "monitored dosage system trays" (MDS trays). These trays comprise arrays of cells, with each cell containing the medicines due at a particular time and date. As an example, one arrangement of MDS tray comprises seven rows and four columns of cells, with each row containing the medicine for one day of the week and within each row each column contains the medicines for a particular time of the day. Other arrangements of rows and columns are common, to suit the dosage regime for different patients. While many patients find that this arrangement makes it easier to take the correct medicines at the right time, these MDS trays neither provide reminders to the patient, nor permit medication adherence to be monitored by remotely located healthcare professionals or carers.

Some attempts have been made to monitor medication adherence in MDS trays, for example by adding patterns of conductive traces over each of the MDS tray cells, with these conductive traces connected to monitoring electronics. As each cell is opened to remove the medicine, the conductive trace for the that cell is broken and the electronics is able to register that the medicine has been removed. The electronics can then report the medicine removal to a remote carer or family member or healthcare professional, for example by using a wireless communications channel. Such systems tend to be expensive, and require significant modifications to the MDS tray, for example the addition of the conductive traces and the monitoring electronics.

In order to permit wider use of remote monitoring of MDS trays it is desirable to detect the removal of medication from an MDS tray that has had no modifications. The present invention presents a means of remotely monitoring medication adherence of patients who are using MDS trays that requires no modification to the MDS trays or to the procedures used in pharmacies to fill the trays. The present invention proposes a monitor into which the MDS tray is placed, the monitor comprising sensors that detect which cells in the MDS tray have been opened, and a means of transmitting this information wirelessly to remote servers, via an intermediate communication gateway.

Further embodiments of the present invention permit the monitoring of consumption of medication contained in conventional blister packs, of the type wherein each cell contains a single medicine tablet and all medicine tablets are of the same medicine type.

BRIEF SUMMARY OF THE INVENTION

According to an aspect of the present invention, there is provided a monitor into which a medication tray may be placed, the tray comprising a plurality of cells containing medication, the monitor comprising sensors that detect which cells in the medication tray have been opened, and a means of transmitting this information wirelessly to remote servers, via an intermediate communication gateway.

BRIEF SUMMARY OF THE SEVERAL VIEWS OF THE DRAWINGS

Figure 1 shows an environment in which the invention may be used; Figure 2 shows the home of a patient in which the invention may be used; Figure 3 shows a medication package comprising an array of cells for storage of medication; Figure 4 shows the elements of a monitor; Figure 5 shows the monitor in plan view; Figure 6 shows a cross-sectional view of the monitor with the medication package installed; Figure 7 shows the elements of the sensor module incorporated into the monitor; Figure 8 shows the elements of a communication gateway.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Figure 1 Figure 1 illustrates an environment in which embodiments of the invention herein described may be used Homes 101, 102 and 103 connect to the Internet 104 and servers 105, 106 and 107 connect to Internet 104 in such a manner that equipment in said homes may communicate with said servers.

Homes 101, 102 and 103 are connected to Internet 104 through communications channels 108, 109 and 110 respectively. Communications channels 108, 109 and 110 may be implemented using a plurality of communications technologies, including GSM wireless technology, broadband technology or telephone lines.

It will be understood that the use of the invention is not restricted to use within homes, but that it may be used in other locations also. Figure 2 Figure 2 shows home 101 of patient 208. Patient 208 uses medication contained in medication package 209. After patient 208 removes medication from medication package 209, patient 208 places medication package 209 into medication adherence monitor 201. Medication adherence monitor 201 incorporates a sensor module which determines when patient 208 consumes the medication by processing signals received from a plurality of sensors placed inside adherence monitor 201. The sensor module incorporated within medication adherence monitor 201 communicates with communications gateway 204 using short-range wireless radio channel 205 and gateway 204 communicates with Internet 104 using communications channel 108.

The sensor module incorporated within medication adherence monitor 201 detects when medication is consumed by patient 208. The sensor module records this information together with the time at which the medication was consumed. The sensor module transmits this information wirelessly to communications gateway 204 either immediately or at a later time. Communications gateway 204 forwards this information to one or a plurality of servers 105, 106 and 107 either immediately or at a later time for subsequent processing and possible interventions.

In the preferred embodiment the medication consumption data is processed in such a manner that a family member of patient 208 is informed when patient 208 takes the medication, or when patient 208 fails to take the medication at the correct time. This enables the family member to take action to assist patient 208 to adhere better to his medication schedule.

In a further embodiment medication consumption data is processed in such a manner that the health care professionals caring for patient 208 can view the patient's medication adherence record and can intervene with the patient to improve the patient's medication adherence.

In a further embodiment medication consumption data is used to determine the content of messages which are displayed to patient 208 on a display incorporated into medication adherence monitor 201. Such messages may be designed to remind patient 208 when it is time to consume the medication, or to display educational information to patient 208 designed to encourage patient 208 to adhere to the medication regime recommended by patient 208's healthcare professionals.

In a further embodiment medication consumption data is used in clinical trials of a medication to provide an accurate record of when patient 208 consumes the medication.

Further uses of the medication consumption data can be envisaged.

Optionally patient 208 may also use other personal health devices 202 and 203 which communicate with communications gateway 204 using short-range wireless radio channels 206 and 207 respectively.

In the preferred embodiment communications channels 205, 206 and 207 are implemented using Bluetooth Low Energy technology. In further embodiments communications channels 205, 206 and 207 may be implemented using VViFi technology or ZigBee technology or other short-range wireless technologies.

In further embodiments communications gateway 204 is not located within home 101 of patient 208 but at a remote location. In these embodiments communications channels 205, 206 and 207 are implemented by long-range wireless technologies. In these embodiments communications channels 205, 206 and 207 may be implemented with the Sigfox technology or LoRa technology or Weightless technology or other long-range wireless technology.

Although the preferred embodiment of the present invention is for monitoring of the consumption of medication, it will be understood that further embodiments permit the monitoring of the consumption further materials contained within further packaging.

Figure 3 Figure 3 shows one embodiment of a medication package 209 in both plan and elevation views. Frame 301 holds a plurality of cells 302, each cell containing medication 304 which is retained by seal 303. Patient 208 releases medication 304 by breaking or removing seal 303.

In a preferred embodiment cells 302 are fabricated from a single sheet of thermoformed plastic and frame 301 is fabricated from paperboard which is die-cut to hold the thermoformed sheet. Seals 303 are fabricated from a single sheet of paper sandwiched between the sheet of thermoformed plastic frame 301. In this embodiment patient 208 releases medication 304 by breaking seals 303 by pressing on the surface of seals 303.

In alternative embodiments frame 301 is fabricated from thermoformed plastic.

In alternative embodiments seals 303 are implemented from sheets of plastic film which are die-cut to match the dimensions of cells 302. In these embodiment patient 208 releases medication 304 by pressing on the surface of seal 303 or by pulling off seal 303 by holding a tab attached to seal 303.

In alternative embodiments cells 302 are attached to frame 301 such that each cell 302 with associated seal 303 can be detached from frame 301 by patient 208 by means of patient 208 pressing cell 302 from frame 301. In these embodiments seal 303 may be removed from cell 302 at some time after cell 301 is removed from frame 301.

In alternative embodiments medication package 209 is a blister pack wherein cells 302 are fabricated from a single sheet of thermoformed plastic and there is no frame 301. In this embodiment seals 303 are formed from a single sheet of foil which is a laminate of aluminium and plastic sheets. In this embodiment each cell 302 contains a single medication tablet 304 and the medication tablets 304 in cells 303 are all of the same type.

Figure 4 Figure 4 shows one embodiment of medication adherence monitor 201 in perspective view. Medication adherence monitor 201 is arranged as a rectangular box with dimensions somewhat larger than medication package 209 such that medication package 209 can be placed inside medication adherence monitor 201 through aperture 401 in the direction indicated by arrow 402.

Optional closure 403 may be closed to secure medication package 209 inside medication adherence monitor 201.

Patient 208 removes medication package 209 from medication adherence monitor 201 then removes medication by breaking one of said seals 303. Patient 208 then replaces medication package 209 into medication adherence monitor 201. Sensor electronics built into medication adherence monitor 201 detects that seal 303 has been broken and records this event.

Optional display 404 may be fabricated on one surface of medication adherence monitor 201. Display 404 may be used to display information to patient 208. Such information could include messages reminding patient 208 when patient 208's medication is next due and information concerning the nature of the medication to be taken. Optionally display 404 may be used to display educational information to patient 208 designed to encourage patient 208 to adhere to the medication regime recommended by patient 208's doctors. It will be understood that if information concerning patient 208's actual consumption of medication can be detected then the messages displayed on display 404 can be adjusted in such a manner as to reinforce correct medication adherence behaviour.

Figure 5 Figure 5 shows medication adherence monitor 201 in plan view. Figure 5 shows display 404 displaying an indicative message to patient 208. Display 404 may be implemented as an LCD display or as an e-ink display or with other display technology.

Figure 6 Figure 6 shows a cross-section of medication adherence monitor 201 with medication package 209 installed being sectioned along line 1-1 of Figure 5.

Sensor module 601 connects electrically to sensors 602. Each sensor 602 corresponds to a cell 302 and when medication package 209 is inserted in medication adherence monitor 201 sensors 602 detect whether seals 303 are present or absent. By detecting the absence of a seal 303 sensor module 601 infers that patient 208 has consumed the medicine contained in the corresponding cell 302.

In the preferred implementation sensors 602 are infra-red proximity sensors whose output is at one level when infra-red light reflects off the seals and whose output is at a different level when said seals have been removed.

In an alternative implementation transmissive optical detection is used. In this implementation sensors 602 are light detectors positioned on one side of each cell. Light emitters are placed on the other side of each cell the tray. If seal 303 is opaque and cell 302 is transparent then the light detector signal is at one level when said seal 303 is present and at a different level when said seal 303 is removed.

In an alternative implementation capacitive detection is used. In this implementation sensors 602 are capacitive sensors. Capacitive sensor arrays are in use as touch switches in electronic equipment. The technology detects a change of capacitance as a finger is brought near a conductor attached to the electronics. Such technology can be adapted to detect varying capacitance depending on the presence or absence of seals 303. It is necessary for said seals to be coated with an electrically conductive material, such as metalised paper or aluminium foil.

In an alternative implementation inductive proximity sensors can be used. In this implementation sensors 602 are inductive proximity sensors, preferably using coils fabricated on a printed circuit board. Inductive proximity sensors are used to detect metallic objects. Either the self inductance of an inductor (single coil) or the mutual inductance of a transformer (two coils) change in the presence of an adjacent conductor. Said inductive proximity sensors detect varying inductance depending on the presence or absence of seals 303. It is necessary for the seals to be coated with an electrically conductive material, such as metalised paper or aluminium foil.

In an alternative implementation mechanical switches can be used. In this implementation sensors 602 are mechanical switches with a moveable arms that are displaced if they touch seals 303. Medication adherence monitor 201 is designed such that when medication package 209 is inserted into medication adherence monitor 201 an array of mechanical switches is positioned above each cell 302. If seal 303 is present then the seal holds the mechanical switch in one state and if seal 303 is absent then the mechanical switch is in the other state.

In an alternative implementation a contact image sensor array can be used. Contact image sensor arrays are used in document scanners. They comprise a linear array of optical sensors, with a light source and lens system. The contact image sensor array moves with respect to the document and the linear array of optical sensors produces a signal that is determined by the colour of the document. In this alternative implementation said contact image sensor array is placed on the inside of medication adherence monitor 201 near aperture 401. As medication package 209 is inserted into medication adherence monitor 201 the signal generated by contact image sensor array will vary depending on whether seals 303 are present or absent. Image processing software running in sensor module 601 determines which seals 303 are present and which have been removed.

Figure 7 Figure 7 shows the principle elements of sensor module 601. Microprocessor 701 comprises a central processing unit, memory, a real-time clock and input/output elements. Microprocessor 701 executes software instructions stored in the memory so as to implement the desired functionality of the sensor module. The real-time clock permits the microprocessor 701 to record the time at which medication consumption events occur. Short-range radio 702 is controlled by microprocessor 701 and communicates wirelessly using antenna 703 with communications gateway 204. Sensor module 601 is powered by a battery 704.

Sensor interface 705 connects to sensors 602 through a plurality of electrical connections 706. Software running on microprocessor 701 receives signals from sensors 602 through sensor interface 705 and detects whether seals 303 are present or absent, and so is able to infer when medication 304 is taken. Software running on microprocessor 701 then stores information about this event, together with the time and date at which the event occurred, in the memory of microprocessor 701. When microprocessor 701 establishes communication with communications gateway 204 it transmits the stored information about the medication consumption event, including the time and date of the event, to communications gateway 204.

It will be understood the detailed implementation of sensor interface 705 will depend on the nature of sensors 602.

Figure 8 Figure 8 shows the principle elements of communications gateway 204. A computing element 801 comprises a central processing unit, memory and input/output elements. Computing element 801 executes instructions stored in the memory so as to implement the desired function of communications gateway 204. Short-range radio 802 is controlled by computing element 801 and communicates wirelessly using antenna 803 with sensor module 601 in medication adherence monitor 201.

Communications gateway 204 contains a second communications element for the purpose of communicating with Internet 104 through communications channel 108. In the preferred embodiment this second communications element is GSM radio 804 which communicates wirelessly with the GSM cell-phone network using antenna 805. It will be understood that further embodiments of communications gateway 204 can use alternative communications channels to the Internet.

Communications gateway 204 may also communicate with further personal health devices 202 and 203 through short-range wireless radio channels 206 and 207.

Software running on computing element 801 forwards messages received from medication adherence monitor 201 and from optional personal health devices 202 and 203 to servers 105, 106 and 107. Optionally, software running on computing element 801 forwards messages received from servers 105, 106 and 107 to medication adherence monitor 201 and to option personal health devices 202 and 203.

Communications gateway 204 is powered by power supply 806. In the preferred embodiment power supply 806 is a mains power supply connected to the domestic mains electricity supply. It will be understood that other power supplies can be used in further embodiments of communications gateway 204.

In the preferred embodiment communications gateway 204 is implemented within a plastic enclosure which plugs directly into a mains power socket through power pins of mains power supply 806. Such a configuration has advantages over other implementations in that no wires are needed to connect between the mains power socket and communications gateway 204. In a further implementation the mains plug present in communications gateway 204 is further extended to provide a mains socket into which electrical appliances may be plugged. Such a configuration has advantages over other implementations in that patient 208 does not lose the use of the mains socket into which communications gateway 204 is plugged.

In a further embodiment communications gateway 204 is implemented by a broadband router. In these embodiments communications channels 205, 206 and 207 are implemented by WiFi technologies and short-range radios 702 and 802 implement the VViFi radio technology.

In a further embodiment communications gateway 204 is implemented by a mobile phone which contains a short-range radio 802. In such an embodiment computing element 801 is the microprocessor that executes the mobile phone applications software. Application software running within computing element 801 may provide a user interface to patient 208. Such application software may issue timed reminders to patient 208, and may permit patient 208 to review his medication adherence and may perform other tasks to assist with improving medication adherence.

In further embodiments communications gateway 204 is not located within home 101 of patient 208 but at a remote location. In these embodiments communications channels 205, 206 and 207 are implemented by long-range wireless technologies and radios 702 and 802 implement a long-range wireless technology.

Claims

Claims 1) An apparatus for monitoring consumption of a substance comprising: a tray containing a plurality of cells for storage of a fluid or solid substance, a means of sealing said substance within said cells, a monitor into which said tray may be placed incorporating a sensor module attached to a plurality of electrical sensors which detect the removal of said substance from said cells, a communications gateway, and at least one remote server; wherein said sensor module communicates with said communications gateway through a first communication channel, and said communications gateway communicates with said remote servers through a second communications channel; whereby the removal of said substance stored within said cells is detected by said sensor module and messages about said removal are transferred from said sensor module through said first communications channel to said communication gateway, and from said communication gateway through said second communications channel to said remote servers.
2) An apparatus according to claim 1 in which said sealing means comprises a plurality of seals fabricated from sheets of thin material whereby each of said seals covers an individual cell and each of said seals can be removed individually by a person in order to remove said substance from said individual cell whilst leaving said substances in said other cells undisturbed.
3) Apparatus according to either of claims 1 or 2 in which said fluid or solid substance is medication to be consumed by a patient in accordance with a desired medication schedule for said patient.
4) An apparatus according to claim 3 in which each of said cells within said tray contain a single medication tablet and each tablet contains the same medication.
5) An apparatus according to claim 3 in which each of said cells within said tray has the capacity to hold a plurality of medication tablets wherein said cells contain a single medication tablet or a plurality of medication tablets intended for consumption at the same time and wherein each of said medication tablets may contain a different medication.
6) Apparatus according to any of claims 1 to 5, wherein said first communication channel is a wireless communication channel.
7) An apparatus according to any of claims 1 to 6, wherein said sensor module comprises a microprocessor, and a radio for communicating through said wireless communication channel, wherein said microprocessor connects to said electrical sensors, whereby said microprocessor detects the removal of said material from said cells and transmits messages about said removal to said communication gateway.
8) An apparatus according to any of claims 1 to 7 in which said electrical sensors are arranged on the inside surfaces of said monitor and in which said tray is inserted into said monitor such that when said tray is inserted into said monitor said cells are located in proximity to said electrical sensors.
9) An apparatus according to any of claims 1 to 8 in which said output of said electrical sensors changes when said electrical sensors detect said removal of said seals.
10) An apparatus according to any of claims 1 to 9 in which said electrical sensors are infra-red proximity sensors whose output is at one level when infra-red light reflects off said seals and whose output is at a different level when said seals have been removed.
11) An apparatus according to any of claims 1 to 9 in which said electrical sensors are capacitive sensors and said seals are coated with a conductive material, whereby the output of each said capacitive sensor is at one level when adjacent to said seals and whose output is at a different level when said seals have been removed.
12) An apparatus according to any of claims 1 to 9 in which said electrical sensors are inductive sensors and said seals are coated with a conductive material, whereby the output of each said inductive sensor is at one level when adjacent to said seals and whose output is at a different level when said seals have been removed.
13) An apparatus according to any of claims 1 to 9 in which said electrical sensors are mechanical switches whose output is at one level when each said mechanical switch touches said seals and whose output is at a different level when said seals have been removed.
14) An apparatus according to any of claims 1 to 9 in which said electrical sensors comprise pairs of optical emitters and optical detectors placed on opposite sides of said cells and wherein said seals are optically opaque and said cells are optically transparent, whereby the output of said electrical sensors is at one level when light is blocked by said seals and whose output is at a different level when said seals have been removed and light passes from said optical emitters to said optical detectors.
15) An apparatus according to any of claims 1 to 9 in which said electrical sensors are implemented by a contact image sensor array located near the aperture of said monitor whereby the output of said contact image sensor array changes as said tray is inserted into said monitor and wherein software executing in said microprocessor processes said output of said contact image sensor array to determine which of said seals have been removed and which are present.
16) An apparatus according to any of claims 1 to 15, wherein said communications gateway comprises a second microprocessor, a second radio for communicating through said wireless communication channel, a second communication channel for communicating with said remote servers and a power supply.
17) An apparatus according to claim 16 where communication through said second communication channel is performed by a cell-phone modem within said communications gateway.
18) An apparatus according to claims 16 or 17 wherein said communications gateway is implemented within a plastic enclosure from which protrude pins that fit a domestic alternating current power supply socket, whereby said communications gateway is powered by said domestic alternating current power supply and is retained by said domestic alternating current power supply socket.
19) An apparatus according to any of claims 1 to 15, wherein said communications gateway is implemented by a broadband router.
20) An apparatus according to any of claims 1 to 15, wherein said communications gateway is implemented by a mobile phone.
21) An apparatus according to any of claims 1 to 20, wherein said communications gateway is located close to said monitor and said first communications channel is implemented with a short-range wireless communications technology.
22) An apparatus according to any of claims 1 to 20, wherein said communications gateway is located remotely from said monitor and said first communications channel is implemented with a long-range wireless communications technology.
23) An apparatus according to any of claims 1 to 22 wherein said monitor incorporates a display controlled by said sensor module on which advice messages relating to the consumption of said substance can be displayed.
24) An apparatus according to claim 23 whereby the content of said advice messages is varied depending on the past history of consumption of said substance.
25) An apparatus according to any of claims 1 to 24 in which said fluid or solid substance is medication, whereby said remote servers process said messages together with said desired medication schedule and may then send further messages to other parties indicating whether said desired medication schedule has been complied with, or not complied with.
26) An apparatus according to any of claims 1 to 24 in which said fluid or solid substance is medication, whereby said servers process said desired medication schedule and in the absence of an expected message indicating said medication has been taken in accordance with said desired medication schedule thereby determine that said medication has not been consumed and may then send further messages to other parties indicating that said desired medication schedule has not been complied with.
27) An apparatus according to any of claims 1 to 26 whereby said servers send said advice messages through said communications gateway to said sensor module for displaying on said display, the content of said advice messages being constructed based on a knowledge of the history of consumption of said medication and said desired medication schedule, said content being constructed so as to encourage improved compliance with said desired medication schedule.
28) A method of determining the consumption of medication contained within a plurality of cells contained within a tray, comprising the steps of: placing said tray into a monitor comprising a sensor module and a plurality of electrical sensors arranged on the inside surfaces of said monitor, connected to said sensor module; detecting the removal of said medication from said cells by said sensor module; when said removal of said medication is detected, transmitting messages concerning said removal of said medication from said sensor module to a communications gateway through a wireless communications channel; and upon reception of said messages at said communications gateway, transmitting said messages through a second communications channel to the Internet and to at least one remote server.
29) A method according to claim 28 wherein said medication is contained within said cells by a sealing means comprises a plurality of seals fabricated from sheets of thin material whereby each of said seals covers an individual cell and each of said seals can be removed individually by a person in order to remove said medication from said individual cell whilst leaving said substances in said other cells undisturbed, and wherein said sensor module detects said removal of said medication by sensing the absence of said seals.
30) A method according to claims 28 or 29 further including the steps of, at said remote servers: processing said messages together with a desired medication schedule; and sending further messages to other parties indicating whether said desired medication schedule has been complied with, or not complied with.