The present invention relates to a device, notably to a device for administering a medicament to a baby, infant or an aged or infirm person, hereinafter collectively denoted as infants, and to a teat for use with such a device.

BACKGROUND TO THE INVENTION:

Many forms of comforter exist for infants in which a teat is mounted upon a disc or other planar member which has a larger diameter so as to prevent ingestion of the teat by the infant as it sucks upon the tea . The teats for use with such comforters are formed as bulbous bodies in the general shape of a woman's nipple and are made as either a solid or hollow moulding of rubber or the like to give a soft feel to the teat in the infant's mouth.

It is often desired to administer a medicament orally to an infant. Whilst this can be done by making the infant swallow a liquid medicament from a teaspoon, this presents an unfamiliar object to the infant and can lead to rejection of insertion of the spoon into the infant's mouth. Alternatively, the infant may spit out the medicament once it enters his mouth and before he has swallowed it. It has therefore been proposed to administer the medicament by means of the teat of a feeding bottle or comforter to which the infant is accustomed. Thus, for example, the medicament in liquid form is contained within a separate reservoir or chamber within a feeding bottle. The medicament is diluted by the contents of the feeding bottle as both are drawn into and through the teat by the sucking action of the infant, the sucking action also causes the fluid entering the infant's

mouth to be swallowed by the infant. However, this requires the infant to consume the entire contents of both the feeding bottle and the medicament reservoir in order to admmster a known amount of medicament. It is commonplace for an infant to reject its feeding bottle after having consumed only part of its contents. The infant will thus have consumed an unknown dose of the medicament. In order to reduce this problem, it has been proposed to form the medicamenent reservoir with a pump mechanism, for example a syringe type mechanisn as described in US Patents Nos 5,383,906, 5,354,274 and 5,244,122, and to expel the medicament in the reservoir into the infant's mouth by depressing the proximal end of the syringe plunger to perform the emptying stroke of the piston in the syringe bore. Such a mechanism requires manual intervention of the mother or other person supervising the infant to ensure that the medicament is ejected. Furthermore, such ejection results in the sudden flow of medicament into the infant's mouth, which may be uncomfortable and unpalatable for the infant, leading to gagging or rejection of the medicament so that the amount administered is erratic.

In order to reduce the problems of such feeding bottle type devices, it has been proposed in European Patent

Application No 0681824 Al to administer medicaments via a conventional infant's comforter teat so as to provide an administration device which is acceptable to the infant. The comforter comprises a conventional hollow teat having a medicament reservoir attached thereto and in fluid flow communication with the teat. The reservoir is charged with the required dose of medicament and the inf nt acquires the medicament by sucking on the teat .

However, in order to regulate the flow of medicament to the infant, it is stated to be essential to provide a

valve or flow control means in the flow path between the reservoir and the interior of the teat . This imposes additional costs and complexity on the device. A similar device is dislosed in German Gebrauchsmuster No 9006946.

We have found that the problems of achieving substantial complete emptying of a reservoir under the influence of an infant's suck are due at least in part because the suction of the infant's suck causes a hollow teat to collapse and thus prevent the infant's suction from being transmitted to the reservoir. We have also found that with long reservoir/syringe mechanisms of for example US Patent No 5,244,122, the infant's suck is insufficient to move the piston within the syringe and it is thus necessary to move the piston manually within the bore of the syringe to achieve discharge of the medicament from the syringe.

We have now devised a form of comforter and teat which reduce the above problems. In the comforter of the invention, the teat incorporates a conduit which provides a bore which directly connects the outlet of the teat through which medicament is discharged into the infant's mouth with the reservoir so that the suck of the infant on the teat directly applies suction to the reservoir and can thus remove medicament from the reservoir without the need for manual operation of a piston within the reservoir. The provisionm of the conduit within the teat also reduces the risk that the sucking action of the infant on the teat will cause the teat to collapse and thus prevent the flow of fluid from the reservoir to the outlet of the teat as occurs with conventional hollow teat.

SUMMARY OF THE INVENTION:

Accordingly, the present invention provides a device for administering a fluid medicament orally to an infant, which device comprises a reservoir to contain the medicament in fluid flow communication with a teat connected to the reservoir and through which fluid from the reservoir is to be discharged into the mouth of the infant, which teat is to be sucked upon by the infant to draw medicament from the reservoir into the mouth of the infant, which device is characterised in that: a. the teat has an outlet through which fluid is to be discharged into the mouth of the infant and an inlet in fluid flow communication with the reservoir, said inlet and outlet being directly connected by a conduit located within said teat or in a wall of the said teat; b. the reservoir has an outlet in fluid flow communication with the inlet of the conduit in the teat; the reservoir being configured so that suction applied by an infant to the teat will draw fluid from the reservoir.

The term direct is used herein to denote that the conduit does not connect with any other source of fluid apart from the reservoir.

For convenience, the term distal will be used herein to denote that end of the device which is to be insertd into the mouth of the infant and proximal for the other end of the device.

Typically, a baby will apply a suction of about 0.05 to

0.1 bar when it sucks on a teat, although an adolescent or adult may achieve up to about 0.5 bar. It is therefore

preferred that fluid is drawn from the reservoir of the device of the invention when a suction of about 0.1 bar below atmospheric pressure is applied to the outlet of the reservoir. Such a performance for the reservoir can be achieved in a number of ways. For example the reservoir can be formed as a generally cylindrical hollow member with a bellows construction to part or all of the side wall of the cylinder so that the cylinder collapses axially as the suction is applied; or the reservoir can be formed as a distensible bag or the like which collapses as the fluid is withdrawn from the bag. If desired, such a reservoir can be configured and dimensioned so that it applies a small positive pressure to the fluid within it when the reservoir is fully charged. For example, the reservoir can be formed so that its relaxed capacity is from 80 to 95% of the volume of the fluid to be charged to it. In this way the reservoir applies a small positive pressure to assist initial flow of fluid through the conduit in the teat.

However, a particularly preferred design of the reservoir is a generally cylindrical shaped member having a bore within which is slideably journalled a piston. The bore acts as the chamber within which the fluid to be discharged is held. As suction is applied to the outlet to the reservoir and fluid flows out of the bore, the piston moves within the bore to accomodate the removal of fluid from the bore and to reduce the internal volume of the bore accordingly, thus allowing the fluid to flow through the outlet without the piston generating significant back pressure within the bore which might impede flow of fluid through the outlet. The piston slides in sealing engagement with the wall of the bore and the form of the annular seal or seals between the radial edge of the piston and the wiped surface of the bore are

such as not to impose excessive sliding resistance between the piston and the wall of the bore. Thus, for use with babies, the suction required to move the piston would be about 0.1 bar. This can be achieved by forming the piston and seal assembly so that it is a loose sliding fit within the bore due to the dimensions of the components, for example to provide an interference fit between the wall of the bore and 0 rings or other annular seals carried by the piston so that the seals do not exert more than a minimal radial force on the wall of the bore. However, due to manufacturing tolerances, it may not be possible to manufacture the device consistently with sufficient accuracy to achieve the desired sliding fit of the piston within the bore. It is therefore preferred to form the seals as radially extending flexible ribs or webs which at rest are inclined so that the radially outward extremities of the ribs or webs are directed away from the outlet of the reservoir when the piston member is located in the bore. Such a construction of the seal will accommodate manufacturing variations without causing binding of the piston within the bore and assists sliding movement of the piston member within the bore during the emptying of the reservoir. The ribs or the tips thereof can be formed from any suitable flexible rubber or plastic material and whether a given design of seal is satisfactory can readily be determined by applying a suction as described above to the outlet of the reservoir to establish that the piston moves within the bore under the applied suction.

If desired, the wall of the bore can be made from or be coated with a low friction material, for example a polytetrafluorohydrocarbon, to assist smooth and easy movement of the piston within the bore.

The ease of movement of the piston within the bore can also be varied so as to ensure that the piston does not move too freely within the bore, thus allowing excessively fast release of medicament into the infant's mounth. Thus, the resilience of the annular seals or ribs can be adjusted to impart a greater or lesser resistance to movement and thus act as a throttle to the rate of discharge of fluid from the reservoir. The optimum configuration of the reservoir, the piston and the seals between the piston and the wall of the bore can readily be determined by simple trial and error tests. However, in order that the piston should be readily drawn along the bore within the reservoir by an infant's sucking upon the teat, it will usually be preferred that the bore have a comparatively high diameter to axial length ratio, typically at least 1:2, preferably from 2:1 to 1:1. Such a form of bore is in marked distinction to the long narrow bores described n, for example, US Patent No 5,244,122.

The use of a cylinder and piston construction for the reservoir thus provides a reservoir for the device of the invention which operates automatically m response to the suck of an infant on the teat to which the reservoir is connected without the need for manual operation of the device and which automatically throttles the rate of discharge of fluid from the reservoir without the need for a separate flow control valve to prevent excessively fast discharge into the infant's mouth.

The reservoir is m fluid communication with the teat via the outlet to the reservoir. It will usually oe preferred to connect the reservoir to the proximal side of an intermediate member having a push fit, bayonet connection or screw threaded or other socket or mounting into or with which the outlet portion of the reservoir engages. If

desired, the reservoir can be formed as a cup-like member which is pivotally connected to the intermediate member to allow the reservoir to be pivotted away from the intermediate member to expose the open end of the bore or other fluid receiving chamber in the reservoir to allow fluid to be charged to the reservoir. The cup-like member is then pivotted back so that its rim engages the intermediate member and thus forms the closed reservoir. In this case the outlet to the reservoir is provided in the intermediate member which effectively forms the end wall of the reservoir when the device is in the closed configuration. The rim of the cup-like member and/or the intermediate member may be provided with co-operating annular grooves, ribs or seals to form a fluid tight seal when the device is closed. The intermediate member and the distal end of the reservoir can be provided with snap engaging ribs or the like which provide a snap fit or other locking mechanism for retaining the device in the closed position.

Thus from another aspect, the present invention provides a device for administering a fluid medicament to an infant via a teat in fluid flow communication with a reservoir for the fluid medicament, characterised in that the device comprises: a. a teat having an inlet at or adjacent its proximal end to receive fluid from the reservoir and an outlet at or adjacent its distal end through which fluid fed to the teat from the reservoir is adapted to flow into the mouth of the infant; b. a conduit within the teat directly connecting the said inlet to the said outlet for the direct flow of fluid medicament from the reservoir to the outlet of the teat; c. an intermediate member located intermediate the

proximal end of the teat and the distal end of the reservoir and adapted to securely receive and locate the teat and to receive the reservoir; d. a reservoir formed integrally with, or demountably secured to, the said intermediate member and being in fluid flow communication via said intermediate member and said conduit with said teat outlet.

The intermediate member may extend radially to form a generally planar member having radial dimensions which prevent the device from being ingested by an infant.

The intermediate member carries on its distal side the teat through which the fluid from the reservoir discharges as the infant sucks on the teat. The teat for use in the present invention is characterised in that it is provided with a conduit which provides a direct fluid flow connection between the outlet to the teat and the outlet to the reservoir. The use of such a conduit ensures that the sucking action of the infant on the teat does not collapse the fluid passage between the reservoir and the teat outlet as occurs when a conventional hollow teat is used. Such a conduit conveniently takes the form of a tube formed during the manufacture of the teat which is an integral part of the teat. Thus, the tube can be formed as a generally central tube passing up the interior of the teat and connected to the outlet of the teat at its distal end and to the proximal end wall of the teat so as to form a duct which is separate from the remainder of the interior of the teat. Preferably, the remainder of the teat forms a closed chamber when the teat is connected to the reservoir outlet and/or to the intermediate member. Thus, the teat can be formed with a transverse shoulder at ts proximal end which is clamped between the distal

end of the reservoir and the intermediate member to provide a sealing interface between the reservoir and the intermediate member. The transverse shoulder can surround a socket or recess into which the outlet to the reservoir engages to provide a sealed fluid flow passage between the interior of the reservoir and the conduit in the teat. Such a passage provides the sole fluid connection between the teat and a source of fluid, that is the reservoir is the sole source of fluid in connection with the teat, and the sole outlet to the teat is that served by the conduit, This ensures that the suction applied by the infant to the teat is applied directly to the reservoir with minimal loss of suction. This is to be contrasted with the devices of, For example US Patent No 5,383,906, where the teat is fed with fluid from two or more sources (the medicament reservoir and the milk or other drink bottle) so that the suction applied by the sucking action of the infant is dissipated between those vessels and is not concentrated solely upon the medicament reservoir. In order to optimise the performance of the conduit, it is preferred that it should have a length to diameter ratio of less than 15:1, preferably from 5:1 to 10:1 and that it should have a diameter of from 0.5 to 2.5 mms . We have found that the diameter and form of such a conduit can be selected so that the conduit acts to throttle the flow of fluid from the reservoir so that any manual completion of the discharge of fluid from the reservoir will not cause excessive discomfort to the infant . The dimensions of the conduit can also be selected to throttle the flow of fluid to the teat and thus prolong the period of discharge of fluid. Typically, the conduit has a diameter such that the flow of fluid through the conduit is from 0.01 to 5 is per second.

The conduit extends from the inlet to the outlet of the

teat, preferably by the most direct route and serves to place the reservoir in fluid flow communication with the teat outlet by a route which has a small fluid volume as compared with a conventional hollow teat. By reducing the fluid volume retained within the teat, problems due to contamination of the medicament in the reservoir due to inflow of saliva if the device is removed from the mouth of the infant or if the infant has an intermittent or poor suck, are reduced. The use of a small volume conduit between the reservoir and the teat outlet also serves to minimise any reduction in suction on the reservoir as the infant sucks on the teat, thus aiding discharge of fluid from the reservoir. It is preferred that the conduit has an internal volume less than 10% of the corresponding hollow teat.

As stated above, the conduit can be formed as a free formed tube extending axially between the teat inlet and outlet and located generally centrally within the internal space within the teat. In this case it may be desirable to form webs or other supporting means extending radially from the wall of the conduit to the walls of the teat. However, a particularly preferred form of conduit is one which is formed integrally with an external wall of the teat, for example as a tube moulded with the internal face of the wall or within the thickness of the wall. Such a form of conduit is more readily formed during injection of other moulding of the teat. Furthermore, the stroking action of the infant's tongue on the teat as it sucks will impart a measure of peristaltic action to the contents of the conduit, aiding flow of fluid to the teat outlet.

Alternatively, the conduit may be formed as a bore within a solid rubber or the like teat. However, we have found that there is a tendency for an infant to reject a hard

solid teat. If the teat is formed from a soft flexible material, for example a closed pore expanded plastic, to make it more acceptable, such softer materials tend to split and crack under the chewing action which infants often impose upon a teat and that the bore collapses when the teat is flexed, thus closing the flow from the reservoir.

Surprisingly, we have found that these problems can be reduced if the interior of the teat surrounding the conduit forms a sealed enclosure when the teat is mounted in position upon the reservoir and/or the intermediate member. We have found that the formation of such a sealed enclosure forms a flexible teat which mimics the feel of a natural nipple and resists the chewing and flexing action of the infant. The sealed enclosure can be formed during the manufacture of the teat by forming the proximal end of the teat incorporating the inlet to the conduit with a transverse end wall or flange to close that end of the teat. Alternatively, the teat can be formed with an open proximal end which is sealed by being clamped between the reservoir and the intermediate member described above or a member associated therewith to form a closed proximal end to the teat .

We believe that such forms of teat are novel, and the invention also provides a teat adapted to be inserted into the mouth of an infant to feed a liquid from a reservoir to the mouth of the infant under the influence of the sucking action of the infant upon the teat, which teat comprises: a. a hollow bulbous body having a distal end for insertion into the mouth of the infant; b. a fluid outlet in the wall of the distal end of the body;

c. a proximal end to the said body for connection to the reservoir and having an inlet for the passage of fluid from the reservoir to the teat; d. a conduit directly connecting the said inlet and outlet for the flow of fluid through the teat; the internal space in said body between the conduit and the walls of the body being formed as, or being adapted to form, a sealed enclosure.

Preferably, the conduit is formed integrally with a wall of the bulbous body and has an internal diameter of from 0.5 to 2.5mms .

The device of the invention can be made from any suitable materials, for example injection or other moulded plastic components for the reservoir and intermediate members and a soft natural or synthetic rubber for the teat.

In use, the reservoir is charged with the fluid medicament or other fluid which it is desired to administer to the infant, for example by opening the reservoir and pouring the required dose of fluid into it. Alternatively, the piston in the bore of the preferred form of the reservoir can be provided with a plunger extending through the proximal end wall of the reservoir housing and this can be used to withdraw the piston proximally within the bore of the reservoir. This will suck fluid into the bore through the teat when the teat is immersed in a bottle or the like of the fluid to be administered. If desired, the wall of the reservoir may be made from a clear material or provided with a clear portion which can carry graduated markings so that a user can determine when the reservoir has been charged with the required dose of fluid.

The teat of the charged device is inserted into the mouth

of the infant. With a baby there is a spontaneous reflex sucking action which applies a suction to the reservoir to draw fluid out of the reservoir and via the conduit in the teat into the mouth of the baby from whence it is swallowed. With the aged or the infirm, this suction and swallowing action may not be spontaneous and will be made consciously. As the fluid is drawn out of the reservoir, the internal volume of the reservoir decreases. With the embodiment in which a piston travels within a bore, the piston travels to accomodate the reduction in volume of the fluid in the reservoir so that little or no suction develops within the bore to impede the free flow of fluid to the teat conduit, thus allowing the reservoir to empty without the need for manual operation of a reservoir discharge mechanism. However, where the infant discards the comforter or is slow or interrupted in sucking the fluid out of the reservoir, a mechanism can be provided, for example the plunger attached to the piston described above, which permits the parent or supervisor of the infant to complete the discharge of fluid from the reservoir. In view of the comparatively fine bore of the conduit, such a manual discharge need not cause excessively rapid discharge.

As indicated above, the device can be used to administer a medicament to an infant and reduces the need for any manual intervention in the adminstration of the medicament and reduces the risk of rejection of the medicament or erratic administration of the medicament. However, the device can be used to administer other fluids, for example sweet pacifying drinks or the like. The term fluid as used herein is therfore used to denote any fluid, suspension or emulsion which it is desired to administer to the infant .

Furthermore, the invention has been described above with respect to the presence of a single conduit connecting the reservoir and the teat outlet. Where the device is to be used to administer medicament to an adolescent or adult person, it will be appreciated that the user may accept a greater flow of medicament than a baby. It is therefore within the scope of the present invention to provide more than one conduit within the teat, each conduit connecting an outlet from the reservoir with an outlet from the teat.

The invention therefore also provides a method for administering a fluid to a person by means of the sucking action of the person upon a teat in fluid flow communication with a reservoir containing the fluid, characterised in that the fluid is contained in a device of the invention.

DESCRIPTION OF THE DRAWINGS:

A preferred form of the device will now be described by way of illustration and with respect to the accompanying drawings in which Figure 1 shows in exploded component form a device of the invention with a piston journalled for axial movement in a cylinder bore acting as the reservoir; Figure 2 shows an alternative form of the device of Figure 1; Figures 3 and 4 show two methods of charging the device of Figure 1 with fluid from a bottle; Figure 5 shows the device of Figure 1 charged with fluid; and Figure 6 shows an alternative form of the device of Figure 1.

DESCRIPTION OF THE PREFERRED EMBODIMENTS:

In the form of device shown in Figure 1, a hollow teat member 40 has an axial tube 41 therethrough supported by

radial webs 42 extending to the inner walls of the teat as shown in the sectional view. The teat 40 locates in an aperture 43 in a hub member 44 and is retained by radial shoulder 45 at the proximal end of the teat 40 bearing against the proximal face of hub 44. Hub 44 has on its proximal face an upstanding annular skirt 46 and a radially extending flange 47.

A reservoir member 50 engages with skirt 46 and comprises a generally circular cross-section hollow body member 51 having its distal end open and its proximal end closed by transverse wall 52. Body member 51 can be a push, screw or other fit within or upon skirt 46 so that the enclosed spaced defined by body 51 and skirt 46 forms the reservoir 50. However, it is preferred to provide a mounting member 53 which locates as a push fit within skirt 46. Member 53 has an axially extending spigot 54 surrounding an axial bore 55 which registers with and engages a corresponding socket 56 in teat 40 which is located at the proximal end of bore 41 in the teat 40. Member 53 also traps shoulder 45 against the proximal face of hub 44 to retain teat 40 in position upon the hub 44 and to seal the internal space within the teat 40 around conduit 41. Member 53 carries the hollow body 51 thereon. Preferably, as shown, the body 51 is connected to member 53 by a pivot or hinge 57 and body 51 carries a circumferential latch member 58 which engages with a circumferential groove or catch 59 on skirt 46. Body 51 can thus be pivoted about hinge 57 between an open position at which the internal cavity of the body is exposed as shown in Figure 4 to a closed position as shown in Figure 5 in which the latch and catch engage to retain body 51 upon skirt 46 with member 53 bearing against shoulder 45 to retain teat 40 in position upon hub 44. In the alternative form of device shown in Figure 6, member 53 can be formed as a separate component

which fits within the annular skirt 46 and provides the seal to the proximal end of the teat 40. In this case, the member 51 is pivotally attached to a web extending radially fom skirt 46.

Within body 51 is slidably journalled an axially moveable piston 60 which carries an axially extending plunger 61 which protrudes through transverse terminal end wall 52 at the proximal end of body member 51. A user can use the exposed end of plunger 61 to retract the piston 60 in member 51 to draw fluid into the reservoir as shon in Figure 3. Member 51 and the radial sealing ribs on piston 60 are formed so that the application of suction as the infant sucks on the teat draws sufficient vacuum on member 51 to move piston 60 axially in member 51 to follow the removal of fluid from member 51. An enlarged view of a suitable form of radial seal between piston 61 and member 51 is shown in Figure 6 in which the radial tip 100 of the annular seal 101 is flexible and is inclined towards the proximal end of the device. Such a seal assists movement of the piston in the distal direction whilst maintaining a fluid tight seal between the piston and member 51. The position of plunger 61 provides the user with an indication of how much fluid has been withdrawn by the infant from member 51. If necessary, the user can depress plunger 61 to assist discharge of fluid from member 51 into the mouth of the infant, for example if the infant discards the device or has a poor suck.

In an alternative form of the device as shown in Figure 2, a compression spring 62 is located between end wall 52 and piston 60 which biases piston 60 towards member 53 so as to assist discharge the contents of member 51 through bores 55 and 41. The bias of the spring enables discharge of medicament to be completed without the need for a user

to apply pressure to piston 60. The diameter of the orifice at the distal end of bore 41 can be formed sufficiently small for surface tension effects to overcome the expulsive force of spring 62 and retain the meniscus of fluid medicament at the outlet to the bore. This prevents fluid from escaping the device until the sucking action of the infant overcomes the surface tension effects and causes fluid to flow through the outlet. In this way, medicament is not released until the infant activates the device. Furthermore, when the infant ceases sucking, the meniscus will tend to re-form at the outlet to bore 41 so that medicament ceases to flow. The device of the invention thus provides medicament only when the infant is sucking and ingests the medicament .

In use, the tip of teat 40 is immersed in a body of the fluid medicament as shown in Figure 3 and piston 60 is withdrawn axially in body member 51 to draw fluid up into body member 51 through bores 41 and 55. Alternatively, body member 51 is pivoted into the open position shown in Figure 4 and fluid medicament poured into the exposed cavity of body member 51. In either case, body member 51 is charged with a desired dose of medicament as shown in Figure 5. The tip of teat 40 is then inserted into the mouth of the infant and the piston 60 allowed to move axially under the influence of the suction applied by the sucking action of the infant on the teat and the direct flow communication between the outlet of the teat and member 51. Medicament flows via bores 55 and 41 to the outlet of teat 40 from whence it is ingested by the sucking action of the infant .

In tne alternative form of the device shown in Figure 6, the conduit 41 is formed m teat 40 as a tube formed against the side wall of the teat. Such a construction

avoids the need to form internal webs to support the conduit as in the device of Figure 1 and the sucking action aids peristaltic flow of fluid in the conduit.