WO2010075240A1

WO2010075240A1 - Medical device

Info

Publication number: WO2010075240A1
Application number: PCT/US2009/068889
Authority: WO
Inventors: Alessandro Cavecchi; Richard Pavkov; Dilraj Singh
Original assignee: Novartis Ag
Priority date: 2008-12-22
Filing date: 2009-12-21
Publication date: 2010-07-01

Abstract

The invention relates to a guard (2) for a portable medical device (1), particularly an inhaler. The guard comprises a body (4) and a cover (6). The cover is movably connected to the body such that the cover can be displaced along a first axis with respect to the body. The guard further includes a latch (10). The guard is manually configurable between a locked configuration in which the latch is engaged and an unlocked configuration in which the latch is disengaged. The latch, when engaged, substantially prevents relative movement between the cover and body along the first axis in at least a first direction and when disengaged the latch does not prevent such relative movement.

Description

Medical Device

The present invention relates to a portable medical device, particularly an inhaler device and in particular to a guard for an inhaler device comprising a pressurised canister which can be pushed into an actuator housing in order to dispense an aerosol which may include a medicament. The invention is of particular application to a pMDI inhaler device .

Pressurised metered dose inhalers (pMDIs) are a commonly used type of inhaler device. They typically comprise a pressurised aerosol container which contains a formulation to be dispensed. The aerosol container typically includes a body and a valve stem forming part of a metering valve so that the valve stem can be depressed relative to the body so as to actuate the metering valve and emit the metered dose of aerosol and medicament. The container typically is supplied with a predetermined number of metered doses, generally in the order of about 200.

In operation, the aerosol container is typically received within an actuator housing of an inhalation device and the valve stem is brought into engagement with a support block in the housing. The user administers the medicament by moving the container relative to the housing so as to depress the valve stem and thereby release a metered dose, which is typically administered to the user through a port or mouthpiece extending from the housing. After the dose is administered, the valve stem, which is typically spring loaded, biases the container away from the support block so as to again move the container relative to the housing. In this way, a metered dose of medicament is administered by each cycle of linear reciprocal movement of the container relative to the housing.

The present invention provides a guard for a portable medical device, the guard comprising a body and a cover, the cover being movably connected to the body such that the cover can be displaced along a first axis with respect to the body, the guard further including a latch, the guard being manually configurable between a locked configuration in which the latch is engaged and an unlocked configuration in which the latch is disengaged, the latch, when engaged, substantially limits relative movement between the cover and body along the first axis in at least a first direction and when disengaged the latch does not limit such relative movement.

Such a guard can be used to cover an actuation region of a medical device and thereby prevent unwanted actuations of the device by substantially preventing a user from applying an actuating force to the actuation region. Such unwanted actuations can be a particular issue with portable medical devices, such as those which are used to dispense a medication, as they are carried by a user, usually in a bag or pocket where accidental contact with portions of the device is likely. pMDI inhalers which are actuated by applying a force to a top of the container which moves the container into the actuator housing and actuates the valve can suffer from such unwanted actuations. Accidental actuation of an inhaler, for example when in a user's pocket or bag, causes wastage of medication and may result in medication not being available when needed. The guard of the invention provides a lockable cover which is adapted to substantially prevent actuation of a medical device such as an inhaler to which it is attached. The invention will be described with reference to an inhaler device, but it should be understood that the guard is applicable to other medical devices which have an actuation region that could be actuated accidentally .

The guard of the present invention is particularly intended for use with pMDI inhalers . The body may be integrally formed with an actuator housing, or may be adapted to be coupled to an actuator housing, so that the cover substantially prevents direct access to the container. With the body of the guard coupled to the actuator housing a user is prevented from accessing the container by the cover and so cannot actuate the inhaler without using the guard. To actuate the inhaler a user must configure the guard in the unlocked position in which the cover can be moved in a first direction along the first axis. This movement of the cover results in a contact portion of the guard applying an actuating force on the container so that the inhaler is actuated. The contact portion may be a portion of the cover, or may be a portion of a contact member which is mechanically, or otherwise, coupled to the cover.

The latch limits relative movement between the cover and body along the first axis in at least a first direction to an extent that, when coupled to an inhaler, the cover can not be moved so as to actuate the inhaler.

The guard may be resiliently biased into a locked configuration. Such resilient biasing can be achieved using a resiliently deforraable member such as a leaf spring, coil spring, elastomeric element or other suitable means. The resiliently deformable member may be integrally formed with a part of the guard, for example the cover or body, or may be formed separately.

The cover may be rotatable relative to the body about an axis substantially parallel with the first axis in order to change the guard configuration between locked to unlocked. Such a rotatable arrangement may be simple for a user to operate and understand and may simplify construction of the guard. It should be noted that the cover may be rotatable relative to the body only after the cover has been displaced by a predetermined distance along the first axis. Such an arrangement would provide a push and twist mechanism for changing the configuration .

It should be understood that there are many other ways in which the configuration may be changed from locked to unlocked. The guard may include a lock member which can be moved relative to the guard and/or the cover to change the configuration. The lock member may be rotatable, or may be translatable, for example slidable. The lock member may, for example, comprise a collar around the guard which could be rotated round the guard or translated along the guard. In a different embodiment the lock member may comprise a button, or tab, extending from the guard which must be moved in order to change the configuration.

The latch may comprise a projecting tooth on one of the cover and body and a shoulder on the other of the cover and the body. In the engaged position the tooth and shoulder would be aligned along the first axis and cooperate to substantially prevent relative movement between the cover and body along the first axis in at least a first direction. In the unlocked configuration the tooth is arranged away from the shoulder along the first axis such that relative movement is not prevented by interaction between the tooth and shoulder.

There may be more than one tooth, for example there may be four teeth, which may be equally spaced around the guard. The shoulder may be substantially continuous with the exception of one or more gaps through which the, or each, teeth can pass when the guard is in the unlocked configuration .

The guard may include at least one guide channel extending from a gap in the shoulder, the channel being arranged to guide and restrict the movement of the tooth once it has passed through the gap in the shoulder.

The guard may further include a visual indicator. The visual indicator can comprise a window through which an indicator strip can be viewed. The indicator strip and window may be arranged to display a first indication in the locked configuration and a second indication, different from the first indication, in the unlocked configuration. For example the indicator strip could include a colour change from, for example, red, to indicate locked, to, for example, green, to indicate unlocked. It should be understood that other indications could be used, for example symbols, words, patterns, graphics or other suitable indicia. A visual indicator may be attached to the base and the window may be in the cover. This provides a simple layout if the cover is moved relative to the base, for example by rotating, to change the configuration from locked to unlocked.

The guard may include a catch which releasably retains the guard in the unlocked position until the cover is moved along a first axis with respect to the body. This allows the guard to be 'primed' ready to be used and this may allow a more convenient unlocking action.

The guard may include a manually actuable catch release which releases the catch so that the guard is able to return to the locked configuration. This allows the guard to be locked without the need to actuate the inhaler .

The guard may include a dose counter for indicating a number of doses dispensed or remaining in an associated inhaler. The dose counter may be actuated to count a dose when the cover is moved a predetermined amount along the first axis with respect to the body. The dose counter could be actuated by any part of the guard, but may conveniently be actuated by a protruding tooth.

The guard may also include a part of the dose counter, for example some or all of the indicator or a trigger part.

In one embodiment the guard includes a trigger part that is used to actuate an indicator which is located on the inhaler body. It should be understood that the indicator could be located anywhere on the inhaler, for example on the guard, or on the inhaler body. The indicator may be mechanically, or electronically coupled to the trigger, or may communicate wirelessly with the trigger.

The invention extends to an inhaler which comprises an actuator body, a pressurised aerosol container and a guard as described above. The pressurised aerosol container may contain a medicament suitable for administration to a patient by inhalation.

It should be understood that throughout this specification and in the claims that follow, unless the context requires otherwise, the word "comprise", or variations such as "comprises" or "comprising", implies the inclusion of the stated integer or step, or group of integers or steps.

The invention will now be further described, by way of example only, with reference to the following drawings in which:

Figures Ia, Ib and Ic show schematic drawings of an actuation sequence of a pMDI inhaler incorporating a guard according to the invention;

Figures 2a and 2b show a different embodiment of a guard according to the invention which includes a dose counter;

Figure 3a, 3b, 3c and 3d show schematic drawings of an unlocking and actuation sequence of a further embodiment of a guard; and

Figures 4a and 4b show an embodiment of the guard of Figure 3a which includes a reset mechanism.

Figures la, Ib and Ic show schematic drawings of an actuation sequence of a medical device, in this case a pMDI inhaler 1 incorporating a guard 2.

The guard 2 includes a body 4 and a cover 6. The body 4 and cover 6 are coupled together so that they cannot be readily separated. This can be by any suitable means, for example a snap- fit arrangement, screw fit, bayonet fit or other means. The cover 6 is movably connected to the body 4 such that the cover 6 can be displaced along a first axis 8 with respect to the body 4. The guard 2 further includes a latch 10. The guard 2 is manually configurable between a locked configuration in which the latch 10 is engaged (as shown in Figure Ia) and an unlocked configuration in which the latch 10 is disengaged as shown in Figure Ib) . The latch 10, when engaged, substantially limits relative movement between the cover 6 and body 4 along the first axis 8 in at least a first direction 12 , When disengaged, the latch 10 does not limit such relative movement.

The inhaler 1 is a pressurised metered dose inhaler (pMDI) which comprises a container 14 in an actuator housing 20. The container 14 contains a formulation to be dispensed. The container 14 comprises a body 16 and a valve stem 18. The valve stem 18 is coupled to a metering valve within the body 16 so that the valve stem 18 can be depressed relative to the body 16 so as to actuate the metering valve and emit a metered dose of aerosolised medicament from the nozzle 23 and through a mouthpiece 24 of the actuator housing 20.

The container 14 is received within the actuator housing 20 so that the valve stem 18 is engaged with a support block 22 in the actuator housing 20.

The body 4 of the guard 2 is integrally moulded with the actuator body 20 in this embodiment so that there is no defined division between the two parts and the cover 6 is arranged so that a user cannot apply a direct force to a top 26 of the container 14.

The guard 2 includes an indicator window 28 in the cover 6 which indicates in Figure Ia that the latch 10 is engaged and the guard in the locked configuration. The latch 10 comprises a protruding tooth 30 extending from the cover 6, a shoulder 32 on the body 4 and a gap 34 in the shoulder 32 into which the tooth 30 can fit when the tooth 30 and gap 34 are aligned. In the locked configuration as shown in Figure Ia the tooth 30 is aligned with the shoulder 32 along the first axis 8 so that movement of the cover 6 in the first direction 12 along the first axis 8 is restricted by contact between the tooth 30 and shoulder 32.

In use the cover 6 is rotated about the first axis 8 to change the guard into the unlocked configuration as shown in Figure Ib. In the unlocked configuration the tooth 30 and gap 34 are aligned along the first axis 8 and the indication window 28 provides a visual indication that the guard 2 is unlocked. Since the tooth 30 and gap 34 are aligned along the first axis 8 movement of the cover 6 in the first direction 12 is not limited by contact between the shoulder 32 and the tooth 30.

From the unlocked configuration the cover 6 can be moved in the first direction 12 along the first axis 8 relative to the body 4 so that a contact portion {not shown in this figure) of the cover 6 contacts the top 26 of the container 14 and moves the container 14 relative to the actuator housing 20 such that the valve is actuated and a metered dose of medicated aerosol 36 is expelled from the mouthpiece 24 as shown in Figure Ic . This can be referred to as the actuation configuration for the guard 2.

It can be seen from the sequence of Figures Ia, Ib and Ic that the guard 2 substantially prevents actuation of the valve of the container 14 when in the locked configuration. The guard 2 comprises a biasing means that resiliently biases the guard 2 into the locked configuration. In this case the guard 2 includes a coil spring (not shown in these Figures) between the cover 6 and body 4 which acts to resist the relative rotation between the body 4 and cover 6 required to move from the locked to the unlocked configuration. The coil spring {not shown) acts to bias the guard from the unlocked position shown in Figure Ib to the locked configuration in Figure Ia .

In this case the guard 2 uses the spring that forms part of the valve (not shown) of the container 14 to resiliently bias the guard 2 to the unlocked configuration shown in Figure Ib from the actuation configuration in Figure Ic. The valve spring acts to resist the movement of the guard from the unlocked configuration to the actuation configuration, but does not resist the rotation required to unlock the guard. In this case the spring in the guard 2 primarily resists relative rotation between the cover 6 and body 4, while the valve spring resists movement in the first direction 12.

Figures 2a and 2b show a different embodiment of a guard 102 according to the invention in the locked and unlocked configuration respectively. Features of this guard 102 that serve the same function as the features of guard 2 will be referenced by the same numerals incremented by 100.

The guard 102 includes a dose counter 38 which is coupled to a trigger 40 using a coupling 42. The trigger 40 and coupling 42 may be mechanical, electronic, pneumatic or another suitable coupling or a combination of couplings.

The guard 102 comprises a body 104 and a cover 106. In this embodiment the body 104 is not integrally formed with an inhaler, but is adapted to be attached thereto. The body 106 can be attached to an inhaler using any suitable means, for example a snap fit, push fit, screw fit, bayonet fit of other mechanical coupling, using adhesive or welding or any other suitable means.

The detail of a latch 110 can be more clearly seen in these figures. A tooth 130 is aligned with a shoulder 132 in the locked configuration shown in Figure 2a. The contact between tooth 130 and shoulder 132 substantially limits movement of the cover 106 relative to the body 104 in the first direction 12 along the first axis 8.

In the unlocked configuration shown in Figure 2b the cover 106 can be moved in the first direction 12 relative to the body 104.

To change the configuration of the guard 102 from locked to unlocked the cover 106 is rotated 44 until the tooth 130 is aligned with a gap 134 in the shoulder 132 as shown in Figure 2b. In the locked and unlocked configurations a window 128 through the cover 106 displays a portion of an indicator ring 46. The indicator ring 46 is arranged to display a different indication through the window 128 in the locked and unlocked configurations.

A coil spring 48 arranged between the cover 106 and the body 104 resiliently biases the guard 102 to the locked configuration by acting to resist the relative rotation between the body 104 and cover 106 required to move from the locked to the unlocked configuration shown in Figures 2a and 2b respectively. In this case the spring 48 of the guard 102 also resiliently biases the guard 102 to the unlocked configuration position shown in Figure 2b from an actuation configuration (not shown) in which the cover 106 has been rotated to the unlocked configuration, but has not yet been moved in the first direction along the first axis relative to the body 104. The spring 48 of the guard acts to resist relative rotation between the cover 6 and body 4 and also movement in the first direction 12.

In use a user changes the configuration from locked to unlocked by rotating the cover 106 relative to the body and can then move the cover relative to the body in the first direction 8. As the cover 106 is moved relative to the body 104 in a direction 12, a contact surface 50 on the cover 106 contacts an actuating portion of the inhaler and exerts a force thereon to actuate the inhaler.

Figures 3a, 3b, 3c and 3d show a different embodiment of a guard 202 according to the invention moving from the locked to the unlocked configuration and then in an actuation configuration. Features of this guard 202 that serve the same function as the features of guard 2 will be referenced by the same numerals incremented by 200.

In this embodiment the latch 210 mechanism is more complex in that it includes a tooth guide 52 within which the tooth 230 is constrained. A spring 54 biases the cover in a direction opposite the first direction 8. In the locked configuration as shown in Figure 3a the tooth guide 52 provides a shoulder 232 which cooperates with the tooth 230 to prevent movement of the cover 206 relative to the body 204 in the first direction 8. As the cover 206 is rotated relative to the body 204 the tooth 230 moves through the tooth guide 52 and moves the cover 206 in the first direction. 8 relative to the body 204 which rotation and movement in the first direction 8 is resisted by the spring 54. The tooth guide 52 comprises a recess 56 into which the tooth 230 is biased when the guard 202 is in the unlocked configuration as shown in Figure 3c in which an indication changes in the indicator window 228 to inform a user that the unlocked position has been reached. From the unlocked configuration the guard 202 can be moved to an actuation configuration (Figure 3d) in which the contact surface 50 would exert an actuation force on an inhaler to which the guard 202 was attached. A stop 53 is arranged to prevent the tooth 230 from being able to rotate away from the tooth guide 52.

From the actuation position the spring would resiliently bias the guard 202 back to the locked configuration. This guard 202 enables the guard to be moved to the unlocked position and temporarily retained in that position by interaction between the recess 56 and the tooth 230 until the guard is moved to an actuation configuration .

Figures 4a and 4b show an embodiment of a guard 302 similar to that of Figure 3a (the same reference numerals will be used as appropriate) but which includes a reset mechanism 58 which comprises a release lever 60 and a release button 62. In the unlocked position as shown in

Figure 4a the tooth 230 is retained in the recess 56 as in Figure 3c, however should a user wish not to actuate the inhaler the reset button can be pressed which actuates the release lever 60 to force the tooth 230 from the recess 56 as shown in Figure 4b. When the tooth 230 is released from the recess the spring 54 will bias the guard to the locked configuration as before.

It should be understood that the invention has been described above by way of example only and that modifications in detail can be made without departing from the scope of the claims. It should also be understood that features exemplified with respect to only one embodiment are not intended to be so limited and it is intended that such features can be combined with one or more features from one or more other embodiments within the scope of this invention.

Claims

1. A guard for a portable medical device, the guard comprising a body and a cover, the cover being movably connected to the body such that the cover can be displaced along a first axis with respect to the body, the guard further including a latch, the guard being manually configurable between a locked configuration in which the latch is engaged and an unlocked configuration in which the latch is disengaged, the latch, when engaged, substantially limits relative movement between the cover and body along the first axis in at least a first direction and when disengaged the latch does not limit such relative movement.

2. A guard as claimed in claim 1, in which the guard is resiliently biased into a locked configuration.

3. A guard as claimed in claim 1 or claim 2, in which the cover is rotatable relative to the body about an axis substantially parallel with the first axis in order to change the guard configuration between locked to unlocked .

4. A guard as claimed in claim 3, in which the latch comprises a projecting tooth on one of the cover and body and a shoulder on the other of the cover and the body, in the engaged position the tooth and shoulder are aligned along the first axis and cooperate to substantially prevent relative movement between the cover and body along the first axis in at least a first direction, in the unlocked configuration the tooth is arranged away from the shoulder along the first axis such that relative movement is not prevented by interaction between the tooth and shoulder.

5. A guard as claimed in any preceding claim, in which the guard further includes a visual indicator, the visual indicator comprises a window through which an indicator strip can be viewed, the indicator strip and window arranged to display a first indication in the locked configuration and a second indication, different from the first indication, in the unlocked configuration.

6. A guard as claimed in claim 5, in which the visual indicator is attached to the base and the window is in the guard .

7. A guard as claimed in claim 2, in which the guard includes a catch which releasably retains the guard in the unlocked position until the cover is moved along a first axis with respect to the body.

8. A guard as claimed in claim 7, in which the guard further includes a manually actuable catch release which releases the catch so that the guard is able to return to the locked configuration.

9. A guard as claimed in any preceding claim, in which the guard includes a dose counter for indicating a number of doses dispensed or remaining in an associated inhaler, the dose counter is actuated to count a dose when the cover is moved along a first axis with respect to the body by a predetermined amount.

10. A portable medical device, the medical device comprising a body and a guard as claimed in any preceding claim, the body having an actuation portion access to which is substantially prevented by the guard.

11. A medical device as claimed in claim 10, in which the medical device is a pMDI inhaler comprising an actuator body and a pressurised aerosol container.

12. A medical device as claimed in claim 11, in which the pressurised aerosol container contains a medicament suitable for inhalation.