WO2025037101A1

WO2025037101A1 - Medicinal dispensing device and method

Info

Publication number: WO2025037101A1
Application number: PCT/GB2024/052125
Authority: WO
Inventors: Edwards MICHAEL
Original assignee: Olfactive London Ltd
Current assignee: Olfactive London Ltd
Priority date: 2023-08-11
Filing date: 2024-08-12
Publication date: 2025-02-20
Anticipated expiration: 2026-02-11
Also published as: GB202312360D0

Abstract

A container unit including one or more container sub-portions defining one or more corresponding chambers for containing respective liquid medicines, each container sub-portion including an outlet, one or more conduit devices serving to connect the or each of the outlets of the respective container sub-portions to main outlet means, respective sub-portion controllable liquid displacement devices associated with each outlet, a fluid displacing device connected to the conduit device, an actuator for dispensing one or more of the liquid medicines selected from the one or more of the respective sub-portions, and a data processing device arranged to control the or each sub-portion controllable liquid displacement device to displace a desired amount of liquid medicine from the one or more container sub-portions by way of the main outlet means.

Description

MEDICINAL DISPENSING DEVICE AND METHOD

This invention relates to a container and particularly to a container for dispensing a medicament or a mixture of medicaments.

Beneficial mixing of different medicines is well researched as achieving significantly improved patient outcomes.

In the treatment of asthma patients, in particular, the current method of inhaling medicine(s) means that patients can overdose and where they mix more than one medicine using the current system, the overdosing worsens. It is well recognized as a major issue that the current delivery method in asthma treatment is subject to patient misuse.

It is estimated that just in the UK as much as 300 million pounds sterling is wasted every year on unused, or partially used, medication much of which sits in storage cupboards. Around 73 million inhalers are prescribed every year in the United Kingdom. The propellants used in some inhalers are powerful greenhouse gases that contribute to climate change. Even after a cannister of medicine is finished, it still contains these environmentally damaging gases. If every inhaler was disposed of appropriately, in the UK, it would prevent around 512,330 tons of CC eq being emitted.

In a Parliamentary APPG Report, “Improving Asthma Outcomes In The UK”, it was recommended there was the need for:

• consistent and practical electronic health records for asthma

• all patients to master and maintain good inhaler technique - 9 in 10 healthcare professionals did not know how to demonstrate the use of an inhaler, leaving more than a million people at risk of a potentially life-threatening asthma attack

• consistency, collation and use of effective data for asthma

• better use of remote consultations, making it easy for people with asthma to attend appointments and self-manage effectively. Asthma U.K. have comprehensively outlined the vital need for consistent inhaler techniques to be used by patients and understood by relevant medical professionals.

Nearly 1 in 5 (19%) asthma sufferers are not getting their inhaler technique checked, according to Asthma UK, which included a survey of more than 10,000 people with asthma. This is an essential part of basic asthma care that everyone with asthma should be receiving. It is vital that adults and children with asthma get help with their inhaler technique as research shows that almost half of people with asthma are not using their inhaler device(s) properly, often without realising. This means a correct and full dose of medicine can’t get into their lungs where it is needed to protect them from a potentially life-threatening asthma attack. The medicine instead stays in their mouth or the back of their throat, which can also make people more likely to experience side-effects such as oral thrush and a sore throat. According to United Kingdom national guidelines, everyone with asthma should get their inhaler technique checked as part of a yearly asthma review with their medical professional. However, with dozens of types of inhalers that need to be taken in different ways, it can be difficult for doctors and nurses to know how they all work in the most effective way.

According to a first aspect of the present invention, there is provided a container unit including one or more container sub-portions defining one or more corresponding chambers for containing respective liquid medicines, each container sub-portion including an outlet, one or more conduit devices serving to connect the or each of the outlets of the respective container sub-portions to main outlet means, respective subportion controllable liquid displacement devices associated with each outlet, a fluid displacing device connected to the conduit device, an actuator for dispensing one or more of the liquid medicines selected from the one or more of the respective subportions, and a data processing device arranged to control the or each sub-portion controllable liquid displacement device to displace a desired amount of liquid medicine from the one or more container sub-portions by way of the main outlet means.

According to a second aspect of the present invention, there is provided a method of dispensing one or more liquid medicines from a container unit including one or more container sub-portions defining one or more corresponding chambers for containing respective liquid medicines, dispensing, by way of one or more conduit devices connecting respective outlets of the container sub-portions to main outlet means, one or a mix of the respective liquid medicines from the main outlet means, wherein said dispensing is controlled by a data processing device connected to respective subportion controllable liquid displacement devices associated with each container subportion.

Owing to these aspects of the invention, it is possible to deliver a patient-specific programmable dose of medicine.

Advantageously, the medicine(s) are delivered in a spray or mist form through a suitable nozzle arrangement. In this way, the container unit can be in the form of an inhaler device or the like used by asthma sufferers. Alternatively, the output from the container unit can be in the form of flowable liquid in non-mist form for filling or partially filling a suitable further container such as an ampoule for injection into a patient.

The data processing device is arranged to control the or each sub-portion controllable liquid displacement device to displace a desired amount of liquid medicine from the one or more container sub-portions by way of the main outlet means for a patientspecific programmable dose.

The data processing device is advantageously arranged to send and receive data to and from a software application.

The container unit preferably further comprises a source of energy connected to the data processing device, the fluid displacing device and the respective sub-portion controllable liquid displacement devices.

The source of energy provides energy to the fluid displacing device not only to expel a liquid from the main outlet means in a first period of a spray cycle when liquid is caused to flow from the respective container sub-portion, but also to purge the conduit device of any residual liquid substance in the conduit device during a second period of the spray cycle which immediately follows the first period and during which the controllable liquid displacement devices prevent flow of their respective liquid substances from the respective sub-portion. This avoids a liquid, or a liquid mixture being contaminated by a liquid or liquid mixture previously emitted from the container unit.

Preferably, the source of energy is a source of electrochemical energy in the form of a suitable battery, which is advantageously but not necessarily rechargeable.

Advantageously, each container sub-portion is removable from the container.

Advantageously, the respective sub-container controllable liquid displacement devices are piezoelectric pumping devices.

The fluid displacing device is preferably a gas displacing device in the form of, for example, an air pumping device such that the source of energy provides energy to the pumping device not only to expel a liquid spray from the main outlet means but to also purge the conduit device to avoid contamination of subsequent uses.

In order that the present invention can be completely understood, reference will now be made, by way of example only, to the accompanying drawings, in which:-

Figure 1 shows a perspective view of a known fixed dose, fixed volume inhaler device used in the treatment of asthma,

Figure 2 shows a perspective view of a first embodiment of an inhaler device according to the present invention for variable dose, variable volume treatment, Figure 3 shows a perspective view of a second embodiment of the inhaler device according to the present invention, and

Figure 4 shows a diagrammatic representation of the fluid connections within the second embodiment.

Referring to Figure 1 , a well-known container unit 2 in the form of an inhaler device comprises a housing 4 for releasably receiving a single sub-container portion 6 into the top end region of the housing 4 to engage with an actuating mechanism to expel the medicament in the sub-container portion 6 as a fixed dose, fixed volume mist output through main outlet means 10.

Such a fixed dose, fixed volume device is not always the most effective treatment for an asthma patient.

Referring to Figure 2, a first embodiment of a container unit 2a according to the present invention comprises a housing 4a, the housing arranged to releasably receive a container sub-portion forming a chamber containing a liquid medicine (not shown). Operation of the container unit 2a is controlled by a data processing device embedded within the housing 4a which is arranged to receive data from a software application installed on a further data processing device in the form of a computer device, such as a mobile communications device or tablet computer. The software application receives input data from a medical professional user and the software application communicates, over a wired or wireless connection, with the data processing device within the housing 4a to be able to emit a variable dose, variable volume output of medicine to the patient, the output being tailored to the individual need of the patient. An actuator 8a in the form of a pressable button causes the programmed dosage/volume to be expelled from main outlet means 10a and into the mouth of the patient. It is of course important that only the medical professional is able to input dose and volume regimes into the software application. The container unit 2 also includes a graphical patient interface display 12a which can be arranged to display information relevant to the patient.

The data processing device withing the housing 4a is also arranged to send data to the software application for data capture in relation to patient-specific dosage, frequency, and geo-location, which allows determination, amongst other things, of available levels of medicine in the hands of the individual patient and the community at different levels, for example at town/city level; state/county level and national level.

Referring to Figure 3, a second embodiment of the container unit 2b comprises a housing 4b and a plurality of container sub-portions 6b releasably received by the housing 4b, four such container sub-portions 6b being shown, which form substantially equal chambers in which liquid medicines, preferably different to each other, are stored. An actuator 8b in the form of a pressable button causes the set dosage/volume to be expelled from the main outlet means 10b, the output being a single variable dose, variable volume medicine (as for the first embodiment) or a variable dose, variable volume medicine mixture of medicines within any combination of the container sub-portions 6b. Any desired mixing is, again, programmed in the software application by the medical professional user with the device being actuated by the patient.

The software application can also provide the data processing device within the housing 4a, 4b with signals to produce aural prompts to the patient, which will also greatly assist sensory-deprived patients in taking their medication accurately and without waste.

A global study of asthma patients by an international team of researchers found a combination of two drugs dramatically reduces the chances of suffering an asthma attack and the present container unit makes this more achievable and simpler to do.

The container unit 2b, via software application instruction, can therefore mix into an output mist different dose amounts and ratios of medicine within that dose. Each container sub portion 6b, as an example, could be programmed to deliver say a 0.1 ml volume of mist made up of a mix of 2% from a first container sub portion, 6% from a second container sub portion, 33% from a third container sub portion and 59% from a fourth container sub portion. In addition, respective misted streams, taken from up to the four sub portions 6b, can also include different particle sizes; for example, 3 microns from a first container sub portion, 5 microns from a second container sub portion, 2 microns from a third container sub portion and 4 microns from a fourth container sub portion. The streams from each sub portion 6b can also be merged into one stream at a variable ratio to each other. For example, the combined stream can be made up of 10% from a first container sub portion, 60% from a second container sub portion, 20% from a third container sub portion and 10% from a fourth container sub portion.

Separate streams of variable sized particles could also be arranged to collide and a 3- micron particle from one stream could, for example, join a 5-micron particle of another stream B resulting in a larger particle of around 8-microns. Pulsed timing of the fluid displacement device for the different streams allows for a gap between each sub stream from the respective container sub portions. Thus, if reguired, a stream can be inhaled as a one stream but be comprised of sub streams separated by an air gap between each stream.

Taking the treatment of asthma as the example, there are currently numerous individual devices used to deliver medicine known as ‘Relievers’, ‘Preventers’ and ‘Controllers’ and these individual devices have to be used in different combinations. The container unit of the present invention combines these in one device where the measure of each medicine is correctly delivered by patient need, delivering significantly better patient outcomes, and offering substantive cost savings.

Referring to Figure 4, a conduit device 12, in the form of a suitably narrow tube has connections with all of the container sub-portions 6b with a pumping device 14 at one end region of the conduit device 12 to produce an air path along the conduit device 12 when actuated and the main outlet means 10b at the opposite end region of the conduit device 12.

Internally of each sub-portion 6, 6b, there is advantageously a dip tube (not shown) that is connected to an outlet of each sub-portion 6, 6b so that substantially all of the liguid substance can be emptied from the sub-portion. Respective check valve devices are associated with each sub-portion to egualize the pressure in each sub-portion and to ensure the dip tubes are always full until the medicine is emptied from the subportion. Each sub-portion 6, 6b also has associated therewith a sub-portion controllable liguid displacement device 16 which are preferably in the form of piezoelectric valves which finely control an amount of liguid entered into the airpath within the conduit device 12.

There could be sub-containers 6b of differing internal volumes depending, for instance, upon the different medicines to be stored therein.

Upon activation of the actuator 8a, 8b, the pumping device 14 produces an air path within the conduit device 12 and the sub-portion controllable liguid displacement device(s) 16 can be arranged to be open for a first period of the spray cycle but closed for a second period of the spray cycle to allow for the purging of the conduit device 12. For example, if a spray cycle has a duration of 1 second, the first period may be 0.5 seconds immediately followed by the second period of 0.5 seconds. The sub-portion controllable liquid displacement devices 16 are electronically operated by an electronic valve controller present in the software application. The data processing device within the housing 4a, 4b is arranged to communicate with the electronic valve controller such that it is possible to open individual electronically operated controllable liquid displacement devices 16 for different time periods of flow during a spray cycle so as to significantly increase the nature of mixtures of the liquid substances one can achieve. Thus, instead of evenly proportioned mixtures such as 50:50 with two liquid substances being mixed, it could be possible to have a mixture of 90:10, for instance.

A source of power for the container unit 2a, 2b is provided by an electrochemical battery connected to the pumping device 14 to enable the pumping device 14 to operate upon actuation of the actuator 8a, 8b. The pumping device 14 enables the purging the conduit device 12 of substantially all of the desired mixture sprayed so that any residual liquid is so negligible so as not to affect the subsequent spray.

The battery 20 is advantageously rechargeable by any suitable means.

The precise control of the piezoelectric pumps enables the selection of any desired combination of the medicines in each of the sub-portions 6b. This would allow a medical professional to mix patient-specific variations by varying the amounts of each medicine in the mixture.

Moreover, the piezoelectric pumps are further arranged to detect a flow of liquid therethrough so that the detection of a respective empty sub-portion 6a, 6b is possible.

The software application only allows the medical professional to mix the medicine so that the patient cannot interfere with the dispensing of the medicines. The software application is therefore sufficiently secure to enable such use. As such, a dose of one or more medicines can be finely adjusted by the medical professional as needed by the particular patient, and all done remotely via the software application. The software application allows remote adjustment by a clinician of dose frequency and dose amount (including particle size mixing as mentioned hereinabove and pulse timing), and it can record all usage detail. The container unit can serve to measure with appropriate sensors and/or detectors exit volume of a dosage delivery and also the time the container unit is in contact with you’re a patient body, for example the lips if the dosage is to be administered orally, and inhalation volume and/or pressure in order to measure inhaled amount of drug taken.

With patient data consent, use of the container unit can be tracked by time, duration of use and location.

There is no use of propellant gases, only pressurised air flow.

The pressure and the content of the mix and the duration of the flow can be adjusted via the software application so that a dose for a child could be delivered at a lower operating pressure with a graduated mix. For example, 0.1 ml delivered over 1 second of flow could be 75% of the mix coming in 0.6 seconds of the flow cycle.

The previously mentioned audio signal can be used to indicate that the full mix has been delivered.

The medical professional can change a treatment regime without re-prescribing a whole new device and can construct a personalised treatment plan for individual patients.

Patient mis-use of multiple inhaler devices would be reduced as only one device needs to be learnt to be used properly.

A part of the software application may be made available to use by the patient to provide for feedback and learning tutorials.

As an alternative to an inhaler, the container unit 2b can be in the form of a portable unit to be carried ‘in the field’ and which can mix medicines from different sub- container portions in a similar way to that already described but the output is not in a mist form but a flowable liquid which can be transferred to an external container such as an ampoule for injection into a patient or into a small cup to be taken orally or applied topically. The field unit would still be controllable via the software application, have a graphical user interface on it and provide the software application with necessary data capture.

The container unit of the present invention could be useful in delivering HRT treatments, treatment of burns, treatment of eczema, treatments for other respiratory disorders, treatment of pain, in delivering human aid to crisis zones, in the defence industry, and in end-of-life care.

The present container unit 2a, 2b allows a live ‘stock take’ of how much medicine is in patient hands at any one point in time and it allows the medical profession to see medicine-related trends starting, through live data capture. It also provides a personalized treatment plan relative to the level of suffering.

Claims

1 . A container unit including one or more container sub-portions defining one or more corresponding chambers for containing respective liquid medicines, each container sub-portion including an outlet, one or more conduit devices serving to connect the or each of the outlets of the respective container subportions to main outlet means, respective sub-portion controllable liquid displacement devices associated with each outlet, a fluid displacing device connected to the conduit device, an actuator for dispensing one or more of the liquid medicines selected from the one or more of the respective sub-portions, and a data processing device arranged to control the or each sub-portion controllable liquid displacement device to displace a desired amount of liquid medicine from the one or more container sub-portions by way of the main outlet means.

2. A container according to claim 1 , and further comprising a nozzle arrangement serving to deliver a spray or mist.

3. A container unit according to claim 1 or 2, wherein the container unit is an inhaler device.

4. A container unit according to any preceding claim, wherein the data processing device is arranged to control the or each sub-portion controllable liquid displacement device to displace a desired amount of liquid medicine from the one or more container sub-portions by way of the main outlet means.

5. A container unit according to any preceding claim, wherein the data processing device is arranged to send and receive data to and from a software application.

6. A container unit according to claim 5, wherein the data processing device is embedded within a housing of the container unit which is arranged to receive data from a software application installed on a further data processing device.

7. A container unit according to any preceding claim, and further comprising a source of energy connected to the data processing device, the fluid displacing device and the respective sub-portion controllable liquid displacement devices.

8. A container unit according to any preceding claim, wherein each container sub-portion is removable from the container unit.

9. A container unit according to any preceding claim, wherein the respective subcontainer controllable liquid displacement devices are piezoelectric pumping devices.

10. A container unit according to any one of claims 7 to 9, wherein the fluid displacing device is an air pumping device such that the source of energy provides energy to the pumping device not only to expel a liquid spray from the main outlet means but to also purge the conduit device to avoid contamination of subsequent uses.

11 . A container unit according to any preceding claim, wherein the liquid medicines include different particle sizes.

12. A container unit according to any preceding claim, wherein the fluid displacement device is arranged to produce pulsed timing for respective streams liquid medicine.

13. A method of dispensing one or more liquid medicines from a container unit including one or more container sub-portions defining one or more corresponding chambers for containing respective liquid medicines, dispensing, by way of one or more conduit devices connecting respective outlets of the container sub-portions to main outlet means, one or a mix of the respective liquid medicines from the main outlet means, wherein said dispensing is controlled by a data processing device connected to respective sub-portion controllable liquid displacement devices associated with each container sub-portion.

14. A method according to claim 13, and further comprising delivering the dispensed liquid medicines as a spray or mist.

15. A method according to claim 13 or 14, wherein the data processing device is arranged to control the or each sub-portion controllable liquid displacement device to displace a desired amount of liquid medicine from the one or more container sub-portions by way of the main outlet means.

16. A method according to any one of claims 13 to 15, wherein the data processing device is arranged to send and receive data to and from a software application.

17. A method according to claim 16, wherein the data processing device is embedded within a housing of the container unit which is arranged to receive data from a software application installed on a further data processing device.

18. A method according to any one of claims 13 to 17, and further comprising removing and replacing respective container sub-portions.

19. A method according to any one of claims 13 to 18, wherein a source of energy provides energy to a fluid displacing device not only to expel a liquid from the main outlet means in a first period of a spray cycle when liquid is caused to flow from the respective container sub-portions, but also to purge the conduit device of any residual liquid substance in the conduit device during a second period of the spray cycle which immediately follows the first period and during which the controllable liquid displacement devices prevent flow of their respective liquid substances from the respective sub-portion.

20. A method according to claim 19, wherein the fluid displacement device is arranged to produce pulsed timing for respective streams liquid medicine.

21 .A method according to any one of claims 13 to 20, and further comprising remote adjustment of the dispensing.