GB2446781A

GB2446781A - Decorative cover for inhaler

Info

Publication number: GB2446781A
Application number: GB0703563A
Authority: GB
Inventors: Martin Sabry; Carl Henry Pullen; Davina Elizabeth Stevenson
Original assignee: Individual
Current assignee: Individual
Priority date: 2007-02-23
Filing date: 2007-02-23
Publication date: 2008-08-27
Also published as: GB0703563D0

Abstract

A hand held device for drug self administration, preferably an inhaler, with a removable decorative cover.

Description

Description:

1.1 Field of the Invention:

Customisation of existing medical devices, such as inhalers, using cosmetic mechanical skins or shells applied either to the device body, or the underlying structure.

In addition, the presented invention relates to improved patient usability and compliance via inclusive design and accessibility principles.

1.2 Objects of the Invention: It is an object of the present invention to facilitate personal customisation of medical devices and in particular to allow adaptation of style, colour and texture, thereby improving patient compliance and medical regimes. The invention achieves this without modification of the existing medical device function and working parts, and therefore will not require full independent qualification and validation.

1.3 Consistory Clauses: **:* According to a first aspect of the present invention this is a method of adapting a medical device to alter its external appearance, whilst retaining the flmctionality and S..... maintaining the original regulatory validation for the device. With this design, aIDEAS addresses the form-function design paradigm of inhalers and other medical devices, such as insulin injection pens.

* aIDEAS recognises that the medical device market is based on established product sales to a captive customer base, whereby the business emphasis typically is on improving business margins through small and incremental manufacturing, logistical * : . : and delivery process improvements, rather than innovative new design.

By removing the embarrassment and stigma attached to using an inhaler in public, patient compliance is better, social and cultural integration is improved. This is particularly relevant for paediatric medical use. Manufacturers win by creating unique devices which reflects their commitment to patient wishes, and thereby increases market share, while necessitating only full qualification of the underlying medical device or medical device caddy.

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2 Brief description of the Drawings:

Embodiments of the invention will now be described with reference to the accompanying drawings in which: Figure 1 illustrates the MDI (Metered Dose Inhaler) with pressurised canister and surrounding body representative of aIDEAS Medical Device Aesthetic Appearance Adaptation Concepts 1 and 2 with a designed outer casing surrounding the MDI Figure 2 is representative of aIDEAS Medical Device Aesthetic Appearance Adaptation Concepts 1 and 2 side proffle with a designed outer casing surrounding the

MDI

Figure 3 is representative of aIDEAS Medical Device Aesthetic Appearance Adaptation Concepts 1 and 2 rear view with a designed outer casing surrounding the

MDI

Figure 4 is an exploded line drawing illustrating conceived fragmentation of aIDEAS Medical Device Aesthetic Appearance Adaptation Concept I. FigureS is a line drawing drawing illustrating aIDEAS Medical Device Aesthetic Appearance Adaptation Stylised Outer (Concept 1 Example Graphics) Figure 6 is a line drawing illustrating aIDEAS Medical Device Aesthetic Appearance Adaptation Concept 2 and indicating the sleeve outer skin and method of application.

Figure 7 is a line drawing illustrating aIDEAS Medical Device Aesthetic Appearance Adaptation Concept 2 and indicating the stylised sleeve outer skin with jewelled design. * S.

Figures illustrates a line drawing of aIDEAS Medical Device Aesthetic Appearance ****** AdaptationConcept3 * ** Figure 9 illustrates a sectioned line drawing of aIDEAS Medical Device Aesthetic Appearance Adaptation Concept 3 and the canister within the shell Figure 10 illustrates a line drawing of aIDEAS Medical Device Aesthetic Appearance Adaptation Concept 3 surrounding the canister within the shell *15S Figure 11 is a line drawing illustrating aIDEAS Medical Device Aesthetic Appearance Adaptation Stylised Outer (Concepts 1,2 & 3) Figure 12 is a line drawing illustrating aIDEAS Medical Device Aesthetic Appearance Adaptation alternative plastic-moulded outer (Concepts 1,2 & 3) Figure 13 is a Line drawing illustrating aIDEAS Medical Device Aesthetic Appearance Adaptation alternative front-fitted plastic-moulded clip-on attachment to the medical device to distract and calm children, whilst allowing original colour and label of medical device to be visible (Concept 4) Figure 14 is a Line drawing illustrating aIDEAS Medical Device Aesthetic Appearance Adaptation alternative rear-mounted plastic-moulded clip-on attachment to the medical device to distract and calm children, whilst allowing original colour and label of medical device to be visible (Concept 4)

3 Detailed description of the Invention:

As required, detailed embodiments of the present invention are disclosed herein; however, it is to be understood that the disclosed embodiments are merely exemplary of the invention, which may be embodied in various forms. The embodiment of the present invention will be described in the context of inhalers -and is envisaged will be applicable for medical devices including insulin pens and EpiPens . Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a basis for the claims and as a representative basis for teaching one skilled in the art to employ the present invention in any appropriate structure.

Other objects and advantages of the present invention will become apparent from the following description, taken in conjunction with the accompanying figures, which constitute exemplary embodiments of the present invention to illustrate various objects and features thereof.

The European Council definition of medical device' is any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application intended by the manufacturer to be used for human beings for the purpose of: * diagnosis, prevention, monitoring, treatment or alleviation of disease, * diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap, * investigation, replacement or modification of the anatomy or of a physiological process, * control of conception, and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means. *..*

The United States (FDA) defines a medical device as an instrument, apparatus, : .. implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is: *..

* recognized in the official National Formulaiy, or the United States * . Pharmacopoeia, or any supplement to them, * intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or * intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.

An inhaler can be defined as a medical device used for delivering medication into the body via the lungs. Where the inhaler can be marketed independently of the active pharmaceutical ingredient, the devices regulations are enforced and CE designations required. The CE mark is a manufacturing declaration that the product meets all the appropriate provisions of the relevant legislation implementing certain European Directives. CE marking gives companies easier access into the European market to sell their products without adaptation or rechecking. Where the pharmaceutical drug and the inhaler are integral, the medicines legislation is followed and a full Marketing Authorisation Application must be granted. Full validation is required, in addition to clinical testing.

Dosing devices for asthma and other respiratory problems rely on transport of medication into the lungs as either aerosol mist of fine particulates via an inhaler.

Inhalers types include thy powder inhalers (DPI) and metered dose inhalers (MDI'S).

A MDI delivers a set dosage of medication to the patient from a pressurised aerosol canister via a metering valve and a valve stem. The method of administration is either by inserting the mouthpiece into the mouth, with closed lips around mouthpiece, or by holding the mouthpiece at a slight distance away from open mouth. To discharge the medication, the patient depresses the canister and simultaneously inhales.

The non-pressurised MDI works on the principle of capillary action of liquid within a chamber.

Some medication, such as anti-inflammatory agents and beta-sub-2-agonists, may be self-administered and with experience a patient will establish a regimen that is appropriate for his or her own medical condition and for their lifestyle. These regimens of maintenance treatment and emergency rapid response treatment may require the patient to periodically use the medical device in public locations, such as places of employment or restaurants. The required manipulation of the standard prior art can be embarrassing in these public environments.

Research has indicated that appropriate patient use and the method of drug administration are key factors in the therapeutic doses of drug needed by the patient.

* ,* In the case of asthma, for instance, the medication would reach the patients' lungs.

* *.. Inappropriate handling can lead to a considerable loss of drug particulates in the mouth and throat. If patients do not take the required time to use the inhaler properly, due to embarrassment in public, can exacerbate this drug loss. * **

:.: This problem of inadequate dosing can also explained by fear of the device and the * * shallow breathing this causes. The device is particularly useful in the administration of medicaments for asthma to children. This concept allows the device to incorporate : a distraction device, such as a plastic moulded toy shape, or bright and friendly colour designs.

Patient compliance and usability has been investigated in other prior art, however, focus has been on a Universal Fastener to ensure constant availability of the inhaler, and an asthma inhaler with a whistle, to allow a patient to check whether or not the drug inhalation has been appropriately accomplished.

Other inhaled products can be envisaged -for example to treat Chronic Obstructive Pulmonary Disease, or treatment of systemic diseases such as diabetes with inhaled insulin. The inhaler is becoming more widely used as an administration device and therefore a greater percentage of the population will become inhaler users.

The present invention is directed to providing an aesthetically improved medical device having the features and improvements set forth above.

3.1 Methods of implementation Different methods of realising the invention are described for exemplary purposes.

These are not to be interpreted as limiting and other methods can be envisaged for realising the converting steps, and hence the invention described.

This patent describes a mechanical middle-ware, working with the existing mechanical assembly. It provides a standard mechanical platform upon which any artist or designer could give the medical device a more stylistic form. The final appearance to the customers and users of the phannaceutical product would have the outermost artistically designed skin', over the mechanical middle-ware. The device referred to in the claims can be any of: an inhaler, a metered dose inhaler, a dry powder inhaler, an injection pen, an EpiPenTh.

The mechanical middle-ware' would allow the inhaler mechanics to remain constant and continue to be manufactured for improved margins, while at the same time allowing many different designers to use this single mechanical middle-ware as a platform for their artistic imaginations.

The patent claims can be achieved by various methods. Combinations of the following four methods and other methods can be envisaged.

Concept 1: Adding one of a nwnber of different cosmetic mechanical skins or shells to the existing device (fragments).

Concept 2: Adding one of a number of different cosmetic mechanical skins or shells to the existing device (single sleeve design) Concept 3: Medical device is designed without an outermost skin, using an inner * ** caddy for holding the medical device, such as the inhaler canister, and a cosmetic outer is applied to this caddy.

Concept 4: Adding one of a number of different cosmetic clips to the existing device to allow visibility of original device colour and labelling.

Figure 1 represents the mechanical skin and its application to a generic Metered Dose * Inhaler. This is illustrative of both Method 1 and Method 2. This represents a handheld device being certified for self administration of a predetermined amount of a medication and having a main body part, a movable working part, and a decorative * cover, the decorative cover being adapted to fit detachably over at least part of the * . main body part so as to be interchangeable by a user and clear of any movable working part so as not to affect the certified operation of the device.

The terms middle-ware, caddy, inner caddy, canister and main body refer to the medical device. The terms cosmetic skin, cosmetic clip and fragment refer to the aIDEAS decorative cover or detachable, clip-on adapter part. The mechanical skin can be comprised of any suitable material, such as polymeric plastic, rubber or other material, and may be artistically styled to appeal to varying patient groups.

Concept 1 and Concept 2 are of similar design once manufactured and fitted, however, manufacturing of the components will differ and the outer design is attached differently. Figure 2 is representative of aIDEAS Concepts 1 and 2 side profile with a designed outer casing surrounding the MDI (p Figure 3 is representative of aIDEAS Concepts I and 2 rear view with a designed outer casing surrounding the MDI. Figure 4 is an exploded line drawing illustrating fragmentation of aIDEAS Concept I. The skin is comprised of two or more fragments which will assemble together to create one outer.

The device of claim I or 2 can consist of a detachable decorative cover comprising a hard shell arranged to be a clip-fit onto the main body part (Concept I). This outer fits around the outer body of the medical device, such as the inhaler, which holds the medication, in for instance a canister. The device of claims 1, 2 and 3 describes the detachable decorative cover comprising a multi-part hard shell, the multiple parts being arranged to clip together around the main body part (via clip-fit mechanism).

The workings of the inhaler or medical device are not altered. In the case of an inhaler both medical function and the design intents of the medical device are maintained and the mouth piece and activation button for canister remain free and the critical dimensions of medical function including distances from mouthpiece to patient mouth, angle of device use relative to the face of the patient and mouth remain unchanged. Graphics can be of any design with the aim to appeal to a varied age range (Figure 5 is illustrative of one such design with a Union Jack motif).

Concept 2 also follows this approach of an outer stylised skin, however, rather than involving manufactured pieces, it is a single body which fits over the outer body of the medical device leaving for instance the inhaler mechanism (activation button and mouth actuator) freely accessible. This is envisaged as a sleeve fitting over the canister. Figure 6 is a line drawing illustrating aIDEAS Concept 2 and indicating the sleeve outer skin. Styling of the aIDEAS Concept 2 is illustrated by Figure 7. In this *:*::* example the stylised sleeve outer skin features ajewelled design.

The aIDEAS Medical Device Aesthetic Appearance outer stylised skin could be manufactured in single, two or more piece mouldings or other methods. Two-piece mouldings could be envisaged to give manufacturing cost advantages.

: Assembly of the outer skin pieces can be envisaged using snap-fit features or any similar attachment method.

*. *...

The aIDEAS Medical Device Aesthetic Appearance methods are envisaged applied * both to design of new medical devices and as enhancement additions to existing medical devices.

The stylised designs will maintain both the critical dimensions of the medical device and the materials required for the functionality of the medical device.

The outer plastic of the inhaler can be replaced by a stylised form which surrounds the pressurised canister of the MDI (as represented by Figure 8). This device is comparable to insulin injection pens. Figure 9 illustrates a line drawing of Concept 3 and the integral shell design. Figure 10 illustrates a sectioned line drawing of Concept 3 and the canister within the shell. A line drawing of Concept 3 surrounding the canister within the shell. This wire representation indicates the integral skin and -l its relationship to the pressurised canister. Concept 3 may involve further validation and both efficacy and safety trials since this device is now integral to the pharmaceutical product.

Stylised adaptations can aid patient compliance, where the basic inhaler shape and appearance can be adapted to appeal to groups of individuals such as teenagers, children or different fashion identity groups, through colour and feature use.

Preliminary concepts include union jack or camouflage graphics. Positive appeal to younger age groups is envisaged through use of child-friendly graphics including cartoon characters and other friendly child appealing design forms. Figure 11 is a line drawing illustrating aIDEAS Stylised Outer (Concepts 1,2 & 3) Each stylised version may also be adapted through textural mechanical outers. Claim refers to a device of any preceding claim whereby the detachable decorative cover comprises a flexible material shaped to fit around the main body part. This may be used to further enhance usability to blind or visually impaired patients. Identification of medical devices, such as inhalers, is usually based upon sight, however, types of medical device or inhaler, and more specifically the active substance within the device or canister, could also be distinguished by touch. Patient safety is therefore enhanced by a simple mechanical outer-shell. This adaptation can be envisaged by bobbling of a flexible rubber shell surrounding the canister, or by plastic moulding to provide ridges, indents or embossing, or other mechanical design methods that impact upon the tactility of the mechanics. The detachable decorative cover therefore comprises three dimensional features for tactile use.

The concept is developed further with plastic moulding of the outer body into a child-friendly shape. The basic canister chamber and inhaler mechanism are unaffected and the activation button and mouth actuator freely accessible. The moulding will reflect the shape of the inhaler body and simple shapes are envisaged, including teddy-bear, s. bumble-bee and ladybird. The head and body of the toy will face the child. The colours and shapes are bright and appeal to children. The combination of colour and style will reduce the fear or any perceived stigma of inhaler use. Efficiency of the * medical device is theiefore enhanced. *.*

Figure 12 is a line drawing illustrating aIDEAS alternative plastic-moulded Outer *. : (Concepts 1, 2 & 3 extension). This design helps to distract and calm children or * could enable rapid distinction between medications.

In devices where the colour and accessibility to the label are critical to the application, the stylised design will be sensitive to these needs. For example, the materials will be opaque or clear, or the styling will not cover the front of the device, but simply cover the rear of the device.

Claim 7 describes how the plastic moulded design can be used as a clip-on plastic attachment rather than a dense full sleeve. The device has a detachable, decorative adapter arranged to fit to the main device body part. This clip, or clips, will surround the existing canister and physical components from the drug manufacturer. Figure 13 is a Line drawing illustrating aIDEAS Medical Device Aesthetic Appearance enhanced medical device front-fitted plastic-moulded "clip-on" Attachment to the outer manufacturers shell to distract and calm children, whilst allowing original colour and label of inhaler to be visible (Concept 4a). Figure 14 indicates how this can be further adapted to be a rear-mounted plastic-moulded Clip attachment to the outer manufacturers shell (Concept 4b). Any feasible arrangement and number of securing clips and adapter ties can be envisaged.

The avoidance or minimisation of re-qualification for cosmetically and textile different outers to the same medical device is achieved through maintaining the mechanical design dimensions and materials that define the medical function of the device.

The inhaler styling is envisaged to be prepared in the conventional inhaler material of medical grade ABS (Aciylonitrile butadiene styrene) or other medical grade material with equivalent properties such as polypropylene, nylons, polycarbonates and other antistatic materials. A material with drug master file should be used to comply with medical device regulations, with particular consideration of the drug path of the aIDEAS Medical Device Aesthetic Appearance enhanced medical device. However, food grade materials may also be considered if the material is not in direct contact with the drug.

Size limitations will be defined by functionality, and should be easily held in the hand. The device design intent is to use one-handed and this will be maintained by the stylised outer. The length from the base of the mouth piece to the button at the top of the canister will be maintained. The dimensions of mouth piece will not be changed. The moulding will be designed such that the angle of the chamber does not affect the positioning and alignment of the mouth piece and can comfortably be used.

* ** This patent describes a detachable decorative cover for use with the handheld device :.: . as described in the disclosed claims. The decorative cover is adapted to fit detachably :. over at least part of the main body part so as to be interchangeable by a user and clear * of the movable working parts so as not to affect the certified and registered operation of the device. ***. * S

* . This invention provides a method of facilitating medical use by child or adult from a medical device, through improved patient compliance and reduced social embarrassment. The aIDEAS Medical Device Aesthetic Appearance Adaptation, according to Claims I and 2, will allow for enhanced paediatric use.

Whilst certain parts of the present invention have been iLlustrated and described herein, it is to he understood that it should not be limited to the specific forms in arrangements of parts described and illustrated. Combinations and permutations of these are envisaged and encompassed by this patent.

Claims

Claims: 1 A handheld device being certified for self administration of

a predetermined amount of a medication and having a main body part, a movable working part, a device component holding medication and a decorative cover, the decorative cover being adapted to fit detachably over at least part of the main body part so as to be interchangeable by a user and clear of any movable working part so as not to affect the licenced operation of the device.

2 The device of claim 1, being any of: an inhaler, a metered dose inhaler, a dry powder inhaler, an injection pen, an EpiPen1".

3 The device of claim 1 or 2, the detachable decorative cover comprising a hard shell arranged to surround the main body part.

4 The device of any preceding claim the detachable decorative cover comprising a multi-part shell, the multiple parts being arranged to clip-fit together around the main body part The device of claim I or 2, the decorative cover comprising a shell arranged to surround the device component holding medication.

* *. 6 The device of any preceding claim the detachable decorative cover comprising a flexible material shaped to fit around the main body part.

7 The device of any preceding claim, having a detachable decorative adapter : arranged to fit to the main body part.

* .* 8 The device of any preceding claim the detachable decorative cover comprising three dimensional features for tactile use.

9 A detachable decorative cover for use with the handheld device described in any preceding claim, the decorative cover being adapted to fit detachably over at least part of the main body part so as to be interchangeable by a user and clear of the movable working parts so as not to affect the certified operation of the device.

A method of facilitating medical device use, according to Claims I and 2, through improved patient compliance and reduced social embarrassment.

11 A medical device according to Claims I and 2, allowing enhanced paediatric use.