The present invention relates to a device for monitoring intake of medication; specifically compliance-to optimal inhalation technique, and compliance to prescription regimen. The device provides short and long term feedback to patients and clinicians on the levels of compliance.

Background to the Invention

A widely used method for delivery of medication to treat Asthma, Chronic Obstructive Pulmonary Disease and other respiratory diseases is by Metered Dose Inhaler. This method of delivery requires a co-ordinated series of actions by the patient to ensure that the medication within the aerosol from the Metered Dose Inhaler is deposited correctly deep in the airways.

The most commonly used method of improving the efficacy of medication delivery from Metered Dose Inhalers is the use of a Valved-Holding-Chamber or Spacer device in conjunction with the Metered Dose Inhaler.

Improper use can be caused by not shaking the Metered Dose Inhaler sufficiently in order to mix medication and propellant prior to actuation, not actuating the Metered Dose Inhaler immediately after shaking, not co-ordinating the Metered Dose Inhaler actuation and inhalation, or not inhaling at an optimal rate or for sufficient duration. It is understood that prolonged poor use of a Metered Dose Inhaler leads to significant problems for patients and ongoing poorly managed conditions.

There are devices available which measure and record the breathing pattern of a patient during the use of a Metered Dose Inhaler by measuring the flow characteristics. Some provide short term feedback to the patient and some record data to be used by patients and clinicians to more closely monitor the use of the Metered Dose Inhaler and to optimise its use to achieve better outcomes. However, none of the devices currently available measure or collect all of the data which can be used during the short or long term optimisation and some have parts which may cause an obstruction to flow, and therefore may cause the medication not to reach the patient’s airways.

Statement of Invention

A medical device to be used in conjunction with a Metered Dose Inhaler and ValvedHolding-Chamber or Spacer which records and aids improvement in the delivery of medicine into the airways comprising;

flow passage with inlet and outlet sides means of connecting inlet side of said flow passage to outlet of a Metered Dose

Inhaler to from a seal means of connecting outlet side of said flow passage to inlet side of a ValvedHolding-Chamber or Spacer to form a seal

Said flow passage may be configured such that the flow of the medication is unobstructed.

Said device may be provided with means of determining duration of agitation before dispensing of medication and correct sequence of user actions thereafter.

Said Device may be provided with pressure sensor to detect dispensing of medication from Metered Dose Inhaler.

The device may be provided with means of determining which medicine is dispensed.

The device may use a pressure sensor to determine the rate and volume of flow of air during use.

The device may be provided with means of indicating real-time inhalation rate to a patient during use.

The device may be provided with means of processing and storing all data collected and 25 then communicating said data to other electronic devices for data analysis.

The device may be incorporated into a system to be used to drive improvement in patient outcomes through detailed analysis of data in the short and long term.

Brief Description of drawings

The invention will be more clearly understood by the following description of one preferred embodiment, given by way of example only, with reference to the accompanying drawings in which:Figure 1 is an isometric view of one preferred embodiment of the present invention shown between a Metered Dose Inhaler and a Valved-Holding-Chamber.

Figure 2 is an isometric view of the preferred embodiment of the present invention shown in Figure 1, after it has been installed between a Metered Dose Inhaler and a V alved-Holding-Chamber.

Figure 3 is an isometric view of the preferred embodiment of the present invention shown in Figure 1, showing the inlet side of the flow passage.

Figure 4 is an isometric view of the preferred embodiment of the present invention shown in Figure 1, showing the outlet side of the flow passage.

Detailed Description

Figure 1 shows an isometric view of one preferred embodiment of the present invention, where the device (1) is shown as an accessory located between a Valved-Holding-Chamber (2) and a Metered Dose Inhaler (3). In this embodiment the device includes an outlet interface which replaces the usual end cap of a compatible Valved-Holding-Chamber or Spacer.

The process of monitoring and recording each use of the device is initiated by depressing the start button (4), which commences a check sequence of the device, including starting a timer and logging the start event. An array of LEDs (8) indicates that the device is ready for use or for fault condition display.

Holding in the start button allows sequential illumination of a coloured LED array. User illuminates their pre-assigned LED colour which relates to the medication type and or dose they are about to take. The illuminated colour is recorded.

As the Metered Dose Inhaler is brought towards the inlet side (5) of the device, the device detects which particular medication is about to be administered before connecting to the Metered Dose Inhaler by, for example detecting the colour of the Metered Dose Inhaler through a sensor (7). The Metered Dose Inhaler is then connected to the inlet side (5) of the device. Once connected, the entire assembly is then shaken to agitate the medication and propellant contained in the Metered Dose Inhaler. This ensures medication is dispensed when the Metered Dose Inhaler is actuated and not just propellant. An accelerometer in the device is used to detect this agitation, and the duration of agitation is recorded by the timer.

The medication is then dispensed from the Metered Dose Inhaler in the normal manner by actuation of the Metered Dose Inhaler canister (9), which outputs a metered dose of medication into the Valved-Holding-Chamber. This preferred embodiment of the invention has a bi-directional through flow differential pressure sensor which has one port (10) to sense atmospheric pressure, and another port (11) to sense the internal pressure of the Valved-Holding-Chamber. This differential pressure sensor will detect the increase in pressure inside the Valved-Holding-Chamber when the medication is dispensed and the time of the event is recorded. That the dispensing of the medication occurs before the medication has had time to settle out of suspension in the Metered Dose Inhaler after agitation will form part of the compliance score achieved.

The patient then inhales the medication, now suspended in the Valved-Holding-Chamber. This causes a change in the internal pressure of the Valved-Holding-Chamber which is detected by the differential pressure sensor. This event is also recorded by the device and forms part of the compliance score achieved. To achieve optimal deposition of the medication deep in the patient’s airways the rate and duration of inhalation are critical.

The differential pressure sensor is used to determine the flow rate from the ValvedHolding-Chamber. A second array of LEDs (12) is located on the outlet side of the device facing the patient during use. These are configured to give real-time feedback to the patient as to how close to the optimum their inhalation rate is, so that they can either increase or decrease their inhalation rate. In this preferred embodiment this achieved by having a central green LED (13) illuminate when the inhalation rate is optimum. One of 2 yellow LEDs (14) on either side of the green LED illuminates when the rate is near optimum, and the patient is prompted to either increase or decrease the inhalation rate slightly dependent upon which LED is illuminated. One of 2 red LEDs (15) on either side of the yellow LEDs illuminates to indicate that the inhalation rate is far from the optimum. This immediate short term feedback to the patient encourages proper use of the device.

All of the data recorded by the device may be stored directly on the device.

The data recorded by the device may also be transferred to a computer or mobile device for analysis against predetermined ranges. This analysis compares the data from the device with predetermined ranges for each criterion and arrives at a percentage compliance score. The compliance scores may be used by the patient or a clinician over the short and long term, so that scores can be monitored to better inform clinical decisions. The score may also be used to quantify any improvement.

The type of medication used in each case can also be determined by manual input, bar coding, RFID tag, mechanical interlock or other suitable means.

The immediate feedback to the patient about the inhalation rate during use may also be provided by other visual, audio or other sensory means.

Claims

1. A device to be used In conjunction with a Metered Dose Inhaler and Valvsd-HoldingChamber or Spacer which records and aids improvement in the delivery of medicine into the

5 airways comprising;

a flow passage with inlet and outlet sides;

means of connecting the inlet side of said flow passage to the outlet of a Metered Dose inhaler to from a seal;

means of connecting outlet side of said llow passage to inlet side of a Valved10 HoldingOhamber or Spacer to form a seal.

2- The device as claimed in alolm 1, further comprising a pressure sensor configured Io detect dispensing of medication from the Metered Dose inhaler1S 3. The device as claimed in claim 2, wherein the pressure sensor Is configured to detect the dispensing of he medication from the metered dose Inhaler into the Valved-holdingchamber.

4. The device as claimed in claim 2 or 3, wherein the pressure sensor comprise a bi-directional

20 through flow differential pressure sensor which has a first port configured to sense atmospheric pressure and a second port configured to sense the internal pressure of the Valved-Holdlng-Chamber

5. The devices as claimed in claim 4, wherein the differential pressure sensor Is configured to

25 detect the increase in pressure Inside the Vaived-HoUIng-Chamber when the medication is dispensed and record the time (hat this occurs.

6- The device es clcimed in daim 6, wherein the differential pressure sensor is configured to detect a change in the internal pressure or the Vah/ed-Holdlng-Chamber when a user Inhales

30 the medication from the Valved-holdlng-chamber.

7- The device as claimed in any preceding claim, further comprising means of determining agitation of the device and the duration of agitation before dispensing the medication.

3S 8. The device aa claimed in claim 7, wherein the meana of determining agitation and the duration of agitation comprises an accelerometer configured to detect the agitation and a timer configured to record the duration of the agitation.

9. The device as claimed in any preceding claim, further comprising a.start button which Is

40 configured to commence a ohaok sequence of the device including starting a timer and logging the start event when the start button Is depressed.

10, The device as claimed in claim 9, furthar comprising an array of LED's located on the inlet side of the device which are configured to Indicate that the device Is ready far use or fault condition display.

11. The device as claimed in claim 10, wherein the array of LED’s comprises a coloured LED array and wherein the LED's are configured to sequentially illuminate when the start button is depressed for a period of time.

10 12. The device as claimed in claim 11, wherein saoh of a plurality of medication types and/or dosages Is pre-assigned an LED colour In the coloured LED array.

13. The device as claimed In any preceding claim, wherein the device is provided with means of determining which medicine Is dispensed.

is

14. The device as claimed in otaim 13, wherein the meana of determining which medicine is dispensed comprises a sensor configured to detect the colour of the metered dose Inhaler.

15. The device as claimed In claim 13, wherein the means of determining which medicine is

20 dispensed comprises manual input, bar coding, RFID tag, meohanloal interlock or other suitable means.

16. The device as claimed in any preceding claim, wherein die device further comprises a pressure sensor configured to determine the rate and volume of flow of air during use.

17. The device as oiaimed in any preceding claim wherein the device Is provided with means of indicating real-time inhalation rate to a patient during use.

16. The device as oiaimed in olaim 17, wherein the means of indicating real-time inhalation rats 30 comprises visual means.

19. The device as claimed In claim 18, wherein the vleual means comprises an array of LEDs located on the cutlet aide of the device.

35 20. The device as claimed in claim 19, wherein the LEDs comprise a central green LED configured to Illuminate to indicate when the inhaialion rate is optimum.

21 · The device as claimed in claim 20, wherein the LEDs further comprise two yellow LEDs which are located on either aide of the green LED which are configured to illuminate to

40 Indicate when the Inhalation rate is near optimum.

22. The device as claimed In claim 21, one <rf the yellow LEDs is configured to Illuminate and to Indicate to a user to Increase the inhalation rats and wherein the other yellow LED Is configured to illuminate to indicate to the user to decrease the inhalation rale when the Inhalation rate is near optimum,

23. The device ae claimed in claim 22, further comprising two red LEDs which are located on either side of the two yellow LEDs and which are configured to illuminate to indicate when ths inhalation rate le far from optimum.

10 24, The device as claimed in claim 17, wherein the means of Indicating real-time Inhalation rate comprises audio or other sensory means.

25. The device as claimed in any preceding claim, wherein the device is provided with means of processing and storing data collected and then communicating said data to other electronic

16 devices tor data analysis wherein the data analysis comprises comparing the data from the device with pre-determined ranges.

28. The device as claimed in any preceding claim, wherein the flow passage la configured such • that the flow of the medication is unobstructed, * 27· A method of using a device in conjunction with a Metered Dose Inhaler and Valved-Holcfing, Chamber or Spacer for aiding Improvement In the delivery of medicine into the airways, the ' method comprising the steps of;

Connecting the motored dose inhaler and valved-holding-ohamber to the device;

26 Shaking the device to agitato tha medication and propellant contained In the metered dose inhaler;

*₍ Actuating the metered dose inhaler to dispense medication Into the valvad-holding¹ chamber;

Detecting Inhalation ef the medication from the valved-hafding-chamber;

30 Displaying an indication of the inhalation rate and how doss this is to the optimum.

28. A metered dose Inhaler and valved holding chamber or spacer Including the device as claimed in claim 1.

Intellectual

Property

Office presewn_

Application No: GB1610684.1 Examiner: Mr Michael Knight