Medicament Inhalers

Abstract

This invention relates to improvements in or relating to medicament inhalers. In particular, the invention relates to a device for releasable attachment to a medicament inhaler, which monitors patient usage of the medicament inhaler. The invention may be particularly suitable for use with medicament inhalers used for the treatment of respiratory diseases.

Description

[0001]This application claims priority to New Zealand Patent Application No. 574666, filed Feb. 5, 2009, the contents of which are hereby incorporated by reference in their entirety.FIELD[0002]This invention relates to improvements in or relating to medicament inhalers. In particular, the invention relates to a device for releasable attachment to a medicament inhaler, which monitors patient usage of the medicament inhaler. The invention may be particularly suitable for use with medicament inhalers used for the treatment of respiratory diseases such as asthma, COPD, cystic fibrosis, and bronchiectasis. However, it is to be understood and appreciated that the invention is not to be limited to such use. For example, the medicament inhalers could be used to supply medicaments to treat diseases such as diabetes, heart disease, and cancer. Furthermore such medicament inhalers could also be used to supply pain medicament, or medicaments to treat disorders such as erectile dysfunction and n...

AI Technical Summary

Benefits of technology

[0042]It is an object of the present invention to provide an improved medicament inhaler which goes some way towards addressing the aforementioned problems or difficulties, or which at the very least provides the public with a useful choice.

Problems solved by technology

The overuse of a reliever medicament has the potential to reduce the effectiveness of the medicament, which may render the medicament less effective in times of real need, for example during a severe asthma attack.

A problem or difficulty associated with the use of preventer (or “combination”) medicament inhalers is poor medicament compliance.

The consequences of poor medicament compliance are reduced disease control, lower quality of life, lost productivity, hospitalisation and avoidable deaths.

Not only is compliance to preventative medicaments typically low, but it has also been shown that actual compliance by a user is lower than the same user's estimated compliance.

There are several problems associated with the use of such mechanical dose counting means.

Firstly, the mechanical switch mechanisms include moving parts which may suffer wear and tear or otherwise deteriorate over time.

Secondly, the switch mechanisms could break off and enter the medicament delivery pathway, and be inadvertently swallowed by the user.

Thirdly, the mechanical switch mechanisms, which are commonly housed inside the actuator, can change the airflow characteristics of the inhaler, which may adversely impact on the medicament delivery performance of the inhaler.

Lastly, mechanical switch mechanisms may be inadvertently triggered by the user, for example during washing of the actuator body to clean away any built up medicament residue (which must be done from time to time).

However, a disadvantage associated with GSK is that the incorporation of a dose counting mechanism into each and every medicament canister adds cost to the end user.

Moreover, given that each canister typically contains a one month supply of medicament, it is economically and environmentally wasteful to supply and then discard such technology with each month's medication.

Hence, because such electronic dose counting means also include moving parts, these parts are likewise susceptible to wear and tear and / or deterioration over time (they may also be susceptible to breaking off and / or interfering with the airflow within the inhaler).

The fitting of such dose counters to an inhaler can therefore be a fiddly or time consuming operation.

More importantly however, any modifications made to the actuator (or canister) have the potential to interfere with the airflow characteristics within the actuator, possibly affecting the effectiveness of delivery of a dose of medicament.

This may result in the patient not receiving the required amount of medicament in order to treat the disease.

Any modifications made to the actuator may also be prone to disruption when washing the actuator.

This may subsequently result in inaccurate dose counting or compliance monitoring (Jewett and Deaton address this issue by housing the compliance monitoring means within a hermetically sealed housing—which increases cost and manufacturing complexity).

A disadvantage associated with absolute dose counters is that they are dedicated to only one canister at a time.

Hence, they are not able to monitor the ongoing compliance characteristics of a user over a period of time which may involve the user going through many canisters of medicament.

Moreover, absolute dose counters are not able to monitor a person's usage over all four seasons to determine useful information such as any seasonal fluctuations.

Absolute dose counters are also not able to monitor the ongoing compliance characteristics of a user should they change medications when only half way through an existing canister.

This presents its own difficulties or limitations.

Firstly, because the compliance monitoring device is integrated with the medicament inhaler, it cannot generally be reused for longer than the life of the inhaler.

Furthermore, compliance monitoring technology, and especially electronic compliance monitoring technology, adds cost when integrated into each and every inhaler.

However, reusing an actuator over more than one medicament canister can lead to residual medicament build-up that reduces the quantity of the drug delivered by the inhaler, and can also change the deposition properties of the aerosol particles, meaning patients get less medication.

Furthermore, repeatedly discarding the plastic and electronic compliance monitoring technology also creates an environmental sustainability problem that needs to be addressed.

Additionally, as not all disease sufferers exhibit poor disease control or poor compliance, it is wasteful to provide such features embedded into each inhaler of a given type.

However, the removal of the electronic module from the sleeve renders the sleeve inoperable, which must then be removed and discarded, which is wasteful and expensive.

Moreover, the fitting of the sleeve and electronic module to an inhaler is a time consuming and complex operation—which may present significant operational difficulties, especially for young children, the elderly or people of reduced mental capacity.

Hence, the McKinnon device cannot be used across a range of different actuators.

However, Walker uses a mechanical counting mechanism (an external plunger-type trigger rod), which has the same disadvantages generally associated with mechanical counting means, as referred to previously.

Hence, Levy requires modifications to the inhaler prior to being able to be used—which has the potential, over time, to interfere with the effectiveness of the inhaler to properly deliver medicament.

Furthermore, the sleeve components described in McKinnon, Walker and Levy would not be able to be used in relation to a medicament canister already fitted with an absolute dose counter, eg the GSK device referred to previously.

Another problem associated with integrated electronic compliance monitoring devices is that many drugs are regulated and require exact actuator conformity.

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