GB2327223A

GB2327223A - Drug delivery device

Info

Publication number: GB2327223A
Application number: GB9714750A
Authority: GB
Inventors: Antony David Roy Marshall; John Derek Wood; Clive Stanger
Original assignee: CAPE HORN ENTERPRISES Ltd
Current assignee: CAPE HORN ENTERPRISES Ltd
Priority date: 1997-07-15
Filing date: 1997-07-15
Publication date: 1999-01-20
Also published as: GB9714750D0

Abstract

A drug delivery device includes a drug storage chamber (4) having an outlet and a face mask (14) connected to the outlet and communicating with the chamber (4). An artificial teat (29) is located within the face mask so that a young infant can be comforted while drug inhalation is proceeding. Furthermore, the teat (29) has the effect of attracting the young infant to the device, simplifying drug delivery. The artificial teat (29) may be in the form of a child's dummy, ordinary bottle teat for oral delivery or other comforter. Oral, nasal or oral/nasal delivery can be achieved.

Description

DRUG DELIVERY DEVICE The present invention relates to a drug delivery device and, in particular, a drug delivery device for use with infant asthma sufferers.

The incidence of childhood asthma has increased dramatically in recent years and some sources estimate that the figure is between 10-20% of under fives.

Adult asthma treatment generally involves the use of a portable nebulizer by the patient which delivers a predetermined drug dose which is taken orally. The technique usually involves directing the nozzle of the nebulizer into the mouth and activating the emission of a dose of aerosol using an appropriate trigger mechanism.

The patient simultaneously breathes the aerosol, delivered into the oral cavity, into the lungs. The technique, although suitable for adults, requires too much dexterity and timing to be suitable for use with young infants. To relieve this problem a drug storage chamber fitted with a face mask has been developed. The drug storage chamber has an inlet which is adapted to be close fitting with known nebulizers so that a dose of aerosol can be delivered into the drug storage chamber. The face mask communicates with the interior of the drug storage chamber and is placed over the infant's mouth and nose. The action of the infant's breathing delivers the drug to the infant's lungs. Unfortunately, the technique suffers from a number of disadvantages. The storage chamber is rather large as it is designed to maintain the aerosol in the vapour phase as long as possible. The placement of the face mask over the infant's mouth and nose may cause considerable distress in the infant which can be further aggravated by the size of the device.

Furthermore, the drug delivery is dependent on the child's breathing rate and cooperation but in infants, particularly those under five, this co-operation may be difficult to obtain.

It is an object of the present invention to provide an improved drug delivery device.

According to the present invention there is provided a drug delivery device comprising a drug storage chamber having an outlet and a face mask connected to the said outlet and communicating with the said chamber, wherein an artificial teat is located within the face mask.

Preferably, the artificial teat is in the form of a child's dummy, ordinary bottle teat or other comforter.

Advantageously, by locating the teat within the face mask a young infant can be comforted while drug inhalation is proceeding. Furthermore, the teat has the effect of attracting the young infant to the device, simplifying drug delivery.

Optionally, the teat is hollow with at least one hole, but, preferably, multiple perforations, in the head and communicates with the drug storage chamber to effect oral delivery of the drug during the sucking action. Alternatively, the teat does not communicate with the drug storage chamber but is located adjacent to at least one hole in the face mask, but, preferably, several, which communicate(s) with the chamber outlet so that nasal delivery proceeds via nasal breathing whilst the infant proceeds to suck the teat. It is also envisaged that simultaneous oral and nasal delivery may take place by combining the two alternatives. Each of the alternatives has particular advantages and can be specifically utilised when oral, nasal or oralinasal delivery is required.

A further advantage of the delivery system is the empty teat which may cause the infant some anxiety causing it to increase its rate of breathing.

However, a further embodiment is envisaged which connects the teat to a further cnamber adapted to contain a suitable drink. In this manner the drug can be optionally delivered via nasal delivery during feeding. Preferably, the feeding chamber is wholly contained within the drug storage chamber.

Preferably, the outlet of the chamber communicates with the face mask via a delivery neck. The delivery neck, preferably, includes a baffleplate to regulate the flow of air into and out of the face mask.

The face mask may be of any suitable design and material known to the skilled man.

Similarly, the teat, comforter or child's dummy is shaped and made from materials known to the skilled man. The teat may be moulded integrally with the face mask or be a separate article screwed or otherwise connected to the face mask by any suitable means. The number and size of the hole or holes in the teat and/or the face mask are not critical but should be sufficient to provide the most suitable rate of delivery. The drug storage chamber may be of the known rigid design used for the delivery of asthma treatment drugs to infants. Preferably, however, at least part of the chamber is resiliently deformable so that the drug delivery from the chamber may be manually adjusted by the child's helper or parent.

Preferably, the base of the teat is mounted on a base plate which is fitted in the face mask, preferably, centrally. The base plate may be fitted with one or more holes to provide a gaseous pathway into the face mask to facilitate nasal drug delivery.

The base plate may be integrally moulded with the face mask or separately mounted therein.

Preferably, the face mask comprises a cup shaped cavity into which the users nose and mouth protrude in use. The head of the teat, preferably, extends just beyond the rim of the mask to facilitate ease of sucking by the infant.

Preferably, the drug storage chamber is fitted with a suitable inlet to accommodate a nebulizer so that a pre-determined dose of aerosol can be delivered to the drug storage chamber. Preferably, the drug storage chamber inlet is shaped to be suitable for fitting to most types of nebulizers.

Preferably, the interior walls of the storage chamber are teflon coated or, alternatively, the storage chamber may be substantially comprised of PTFE. The use of PTFE is advantageous due to its chemical inertness and low coefficient of friction which is believed to help keep the drug in the vapour phase.

The device described is particularly useful for use in the treatment of infant asthma sufferers. However, the invention is not limited to such use and may be utilised for use with any kind of drug where drug delivery in the vapour phase through oral or nasal pathways is required.

An embodiment of the invention will now be described, by way of example, with reference to the accompanying drawings in which:figure 1 shows a perspective view of the drug delivery device; figure 2 shows a view in direction of Arrow II in figure 3; figure 3 shows a view as in figure 2 with a second teat assembly; figure 4 shows a view as in figure 2 with a third teat assembly; figure 5 shows a cross sectional view of a combined nasal and feed delivery; and figure 6 shows a perspective view of figure 1 showing the drug chamber being compressed by a user.

Referring to figure 1, a drug delivery device 2 has a drug storage chamber 4 which is comprised of two frustoconical halves, joined together at their respective wider ends to form a sealed joint. The chamber has an inlet 6 at the distal end thereof which is adapted to be close fitting with the nozzle of known types of nebulizer (not shown) to facilitate drug delivery into the chamber. An outlet 8 is located at the proximal end of the chamber and forms one end of a hollow cylindrical neck 10 which protrudes outwardly from the proximal end of the storage chamber 4 and terminates in a neck opening 12. A face mask 14 comprises a cup shaped cavity 16 which terminates at its proximal end in bulbous rim 18. A face mask hollow cylindrical neck piece 20 depends centrally from the distal end of the face mask and communicates therewith via a hole which is co axial therewith and formed centrally in the base of the cup, having the same diameter as the internal diameter of the neck piece 20. The neck and cup shaped cavity are made of flexible material and the neck is dimensioned so that it forms a friction fit over the proximal end of the chamber neck piece 10 to form a sealed connection therewith which provides an airtight channel between the cup shaped cavity of the face mask and the storage chamber 4. A teat 22 is fitted above the central hole 21 formed in the base of the cup shaped cavity so that the teat protrudes in a proximal direction into the cavity along the cavity's axis of rotation. The teat 22 is mounted on a circular base piece 24 which is of a larger diameter than the central hole 21 in base of the cup shaped cavity 14 and is placed centrally thereover to form a sealed connection with the inner walls of the cavity. The baseplate has three holes 26, 28, 30 formed therein to allow the passage of vapour from the storage chamber via the necks 10, 20 and the face mask hole 21 into the face mask cavity 16.

In use, the infant's mouth and nose are covered by the face mask 14 after an appropriate dose of aerosol has been delivered into the drug storage chamber 4 via the inlet 6. The natural sucking instinct of the infant will cause it to suck on the teat 22 thus providing it with comfort while it breathes through the nasal passageway, inhaling the aerosol from the storage chamber 4.

A hole 31 or holes may also be provided in the teat 29 at both its head and base to allow direct communication with the chamber 4 and simultaneous oral delivery or, alternatively, referring to figure 3, the holes in the baseplate 24 may be removed so that only oral delivery is possible.

Referring to figure 5, a feeding bottle 40 is fitted within the storage chamber 4 and provided with an end threaded neck to communicate with the teat 29 but not the base plate holes so that simultaneous feeding of the infant may take place during nasal drug delivery through an annular cavity 38 between the internal walls of the neck pieces 10, 20 and the neck of the feeding bottle.

In the embodiment shown in figure 5, the next 50 of the feeding bottle 40 is female threaded at the proximal end 42 thereof to form a screw tight fit with a corresponding male threaded protrusion 34 depending distally from the base plate 32. The inner wall of the protrusion 34 defines a neck for close fitting relationship with the base of the teat 29 which widens midway along its length to accommodate the distal rim of the protrusion 34 and to continue in close fitting engagement with the wider neck 50 of the bottle 40. A sealed feed passageway is thus provided from the bottle 40 to the teat hole 31 to effect oral delivery in the direction of oral feed 36. The outer wall of the bottle neck 50 is spaced from the inner walls of the respective necks 10, 20 of the chamber and mouthpiece 14 so that an annular cavity 52 is formed between the bottle neck 50 and the necks 10, 20 of the chamber and mouthpiece. The holes 26,28, 30 formed in the base plate 32 are positioned so as to line up with the proximal end of the annular cavity 52 to allow nasal communication between the mouthpiece and the chamber 4.

Referring to figure 6, the outlet frustoconical portion 48 of the rug chamber 4 is resiliently deformable to provide external adjustment of drug delivery rate by depression or squeezing the said portion. The squeezing is, preferably, effected by the infant's companion.

The reader's attention is directed to all papers and documents which are filed concurrently with or previous to this specification in connection with this application and which are open to public inspection with this specification, and the contents of all such papers and documents are incorporated herein by reference.

All of the features disclosed in this specification (including any accompanying claims, abstract and drawings), and/or all of the steps of any method or process so disclosed, may be combined in any combination, except combinations where at least some of such features and/or steps are mutually exclusive.

Each feature disclosed in this specification (including any accompanying claims, abstract and drawings), may be replaced by alternative features serving the same, equivalent or similar purpose, unless expressly stated otherwise. Thus, unless expressly stated otherwise, each feature disclosed is one example only of a generic series of equivalent or similar features.

The invention is not restricted to the details of the foregoing embodiment(s). The invention extends to any novel one, or any novel combination, of the features disclosed in this specification (including any accompanying claims, abstract and drawings)1 or to any novel one, or any novel combination, of the steps of any method or process so disclosed.

Claims

1. A drug delivery device comprising a drug storage chamber having an outlet and a face mask connected to the said outlet and communicating with the said chamber, wherein an artificial teat is located within the face mask.

2. A drug delivery device according to claim 1, wherein the artificial teat is in the form of a child's dummy, ordinary feeding bottle teat or other comforter.

3. A drug delivery device according to claim 1 or 2, wherein the teat is hollow with at least one hole in the head and communicates with the drug storage chamber to effect oral delivery of the drug during the sucking action.

4. A drug delivery device according to claim 3, wherein there are multiple perforations in the head which communicate with the drug storage chamber to effect oral delivery of the drug during the sucking action.

5. A drug delivery device according to any of the claims 1 or 2, wherein the teat does not communicate with the drug storage chamber but is located adjacent to at least one hole in the face mask which communicate(s) with the chamber outlet so that nasal delivery proceeds via nasal breathing whilst the infant proceeds to suck the teat.

6. A drug delivery device according to claim 5, wherein the teat is located adjacent to several holes between the drug storage chamber and the face mask cavity.

7. A drug delivery device according to claims 1 or 2, wherein simultaneous oral and nasal delivery may take place by combining holes in the teat and between the chamber and face mask cavity adjacent to the teat.

8. A drug delivery device according to claims 1, 2, 5 or 6, wherein the teat communicates with a further chamber adapted to contain a suitable drink.

9. A drug delivery device according to claim 8, wherein the feeding chamber is wholly contained within the drug storage chamber.

10. A drug delivery device according to any preceding claim, wherein the outlet of the chamber communicates with the face mask via a delivery neck.

11. A drug delivery device according to claim 10, wherein the delivery neck includes a baffleplate to regulate the flow of air into and out of the face mask.

12. A drug delivery device according to any preceding claim, wherein at least part of the chamber is resiliently deformable so that the drug delivery from the chamber may be manually adjusted by the child's helper or parent.

13. A drug delivery device according to any preceding claim, wherein the base of the teat is mounted on a base plate which is fitted in the face mask.

14. A drug delivery device according to any preceding claim, wherein the base plate is fitted with one or more holes to provide a gaseous pathway from the chamber into the face mask to facilitate nasal drug delivery.

15. A drug delivery device according to any preceding claim, wherein the face mask comprises a cup shaped cavity into which in use, the users nose and mouth protrude.

16. A drug delivery device according to any preceding claim, wherein the head of the teat extends just beyond the rim of the mask to facilitate ease of sucking by the infant.

17. A drug delivery device according to any preceding claim, wherein the drug storage chamber is fitted with a suitable inlet to accommodate a nebulizer so that a pre-determined dose of aerosol can be delivered to the drug storage chamber.

18. A drug delivery device according to any preceding claim, wherein the drug storage chamber inlet is shaped to be suitable for fitting to most types of nebulizers.

19. A drug delivery device according to any preceding claim, wherein the interior walls of the storage chamber are teflon coated.

20. A drug delivery device according to any of claims 1, 6, 18 wherein, the storage chamber is substantially comprised of PTFE.

21. A method of treating an infant with a drug to be delivered via an aerosol into the nasal or oral breathing pathways comprising the steps of: placing a face mask over the infant's mouth and nose, the face mask comprising part of a drug delivery device comprising a drug storage chamber having an outlet and the face mask connected to the said outlet and communicating with the said chamber, wherein an artificial teat is located within the face mask.

22. A drug delivery device as hereinbefore described with reference to figures 1 and 2.

23. A method of treating an infant as hereinbefore described.