Surgery – Respiratory method or device – Means for mixing treating agent with respiratory gas
Reexamination Certificate
2001-05-11
2003-05-27
Doerrler, William C. (Department: 3744)
Surgery
Respiratory method or device
Means for mixing treating agent with respiratory gas
Reexamination Certificate
active
06568389
ABSTRACT:
The present invention relates to an inhalation device for use in the administration of medicament to a patient. The device has a mouthpiece, which is reversibly retractable from a storage position located inside the body of the device to a dispensing position in which the mouthpiece protrudes from the body of the device.
The use of inhalation devices in the administration of medicaments, for example in bronchodilation therapy, is well known. Such devices generally comprise a body or housing within which a medicament container is located. A mouthpiece (or nozzle) is typically provided, wherein ‘in use’ the mouthpiece communicates with the medicament container to allow passage of medicament from the source to the mouthpiece and thence, to the patient.
In a typical dispensing operation the body of the device is held by the patient and the mouthpiece (or nozzle) of the inhalation device is placed in the mouth (or nose) of the patient. The patient inhales, thereby causing transfer of medicament from the medicament container to the interior of the body of the patient.
When not in use it is desirable, from a hygiene standpoint, that the mouthpiece is provided with some kind of protective cover. The cover desirably acts both to prevent build-up of dirt on the mouthpiece and to prevent ingress of dirt into the body of the device through the mouthpiece, which might then be subject to inhalation by a patient.
It is known to provide the mouthpiece with a protective cap which acts as a protective cover. The cap may either be an entirely separate element or it may be joined to the body of the device in some way. DE-A-3,639,836, for example, describes a device in which the protective cap is mounted on an arm, which is pivotally mounted to the body of the device.
As an alternative to the use of a protective cap, one might envisage a device having a mouthpiece which is reversibly retractable from a storage position in which the mouthpiece is contained within the body of the device to a dispensing position in which the mouthpiece protrudes from the body of the device. In a device of this type the body of the device itself acts as the protective cover when the mouthpiece is in the storage position. The mouthpiece cover is thus an integral part of the inhalation device, avoiding contamination problems of prior art inhalation devices caused by the loss of removable mouthpiece covers.
GB-A-2,074,454 describes an inhalation device comprising a tubular body adapted for detachable fitting to an aerosol container. A mouthpiece is provided, which is movable from a storage position to a dispensing position by means of a cap, rotatably mounted on the tubular body, which has actuating means associated therewith. The cap and tubular body are provided with openings of similar dimensions. Manual rotation of the cap to bring the openings into register causes the actuating means to move the mouthpiece to the dispensing position in which the mouthpiece protrudes from the body of the device. Conversely, rotation of the cap by the user to bring the openings out of register causes the mouthpiece to be moved to the storage position in which the mouthpiece is contained within the body of the device.
For the convenience of the user, it is desirable that the inhalation device is arranged to allow movement of the mouthpiece from the storage to dispensing position (and vice-versa) by a one-handed operation. The device described in GB-A-2,074,454 would be very difficult to operate by means of a one-handed operation since it requires a rotatory movement of the cap relative to the body. This would normally require the user to hold the body in one hand, the cap in another and thence, to perform the required relative rotatory movement.
The Applicants have now found that the desired one-handed operation can be facilitated where the device is shaped for ease of grip by the palm and fingers of one hand and where the mouthpiece is actuable by a motion of the thumb of the same hand. One handed operation is thus, for example, achievable if the user holds the body of the device in the palm of a partially cupped hand and employs the thumb to provide movement to the mouthpiece actuator, thereby causing actuation of the mouthpiece.
According to one aspect of the present invention there is provided an inhalation device for dispensing medicament comprising
a body;
a medicament carrier;
a mouthpiece, reversibly movable from a storage position wherein said mouthpiece is within said body to an in-use position wherein a portion of the mouthpiece protrudes from the body and wherein the mouthpiece is in communication with said medicament carrier to allow passage of medicament therebetween; and
a mouthpiece actuator coupled to the mouthpiece such that actuation of said mouthpiece actuator moves the mouthpiece towards said storage position and deactuation of the mouthpiece actuator moves the mouthpiece towards said in-use position,
wherein said body is shaped to be holdable in one hand and the mouthpiece actuator is actuable in response to a motion of the thumb on the same hand.
The motion of the thumb suitably, but not necessarily, involves contact, and typically engagement, of the thumb with the mouthpiece actuator resulting in the movement thereof.
In one preferred aspect, the body is shaped to be holdable in the palm of one hand.
In another preferred aspect, the body is shaped to be holdable in the palm and by at least one of the fingers of one hand.
In a further preferred aspect, the body is shaped to be holdable by a plurality of the fingers of one hand.
Preferably, the mouthpiece actuator is coupled to the mouthpiece such that movement of said mouthpiece actuator in a first direction moves the mouthpiece towards said storage position and movement of the mouthpiece actuator in an opposing direction moves the mouthpiece towards said in-use position.
Herein the term ‘mouthpiece’ is used in a generic sense to mean an element shaped such as to be insertable into the mouth or nose of a patient for inhalation therethrough.
In one preferred aspect, the mouthpiece actuator and mouthpiece are coupled by a coupling mechanism. In one particularly preferred aspect, the coupling mechanism comprises a rack and pinion mechanism. In another particularly preferred aspect, the coupling mechanism comprises a hinged lever mechanism.
In one aspect the medicament carrier is within the body. In another aspect the medicament carrier is attachable to the exterior of the body.
In another preferred aspect, the mouthpiece actuator and mouthpiece are directly coupled. Preferably the mouthpiece actuator is a rotatable turning device coupled to the mouthpiece. Alternatively a hinge mounting connects the mouthpiece to the body. Preferably the hinge mounting is sprung such as to bias the mouthpiece to the in-use position.
Preferably, the mouthpiece is comprised of an elastic material.
Preferably, the mouthpiece is provided with a cover comprised of an elastic material.
Preferably, the inhalation device additionally comprises a curtain arrangement contactable by the mouthpiece on movement of the mouthpiece from the storage to the in-use position. More preferably, the curtain arrangement comprises a plurality of curtains comprised of an elastomeric material.
Preferably, the mouthpiece actuator is provided with a safety trigger mechanism to prevent accidental actuation thereof.
Preferably, at least a portion of the mouthpiece actuator is shaped for ease of grip by the user.
Preferably, at least a portion of the mouthpiece actuator has a friction-enhancing coating.
Preferably, the device is provided with a dose counter, which indicates the number of doses dispensed from or remaining in the container. More preferably, the dose counter comprises an indexing mechanism actuated by a predetermined movement of the medicament container relative to the body.
Preferably, the medicament container is an aerosol or a dry-powder container.
According to another aspect of the present invention, there is provided the use of an inhalation device provided herein for dispensing medicament.
R
Anderson Gregor John McLennan
Rand Paul Kenneth
Doerrler William C.
Drake Malik N.
Risk James F.
SmithKline Beecham Corporation
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