[01 ] The present invention relates to the field of metered dosage devices for liquids, particularly pharmaceutical liquids.

[02] Presently the options for measuring a dose of a liquid pharmaceutical for oral administration include pouring the liquid onto a spoon, or into a measuring cylinder or withdrawing the liquid into a syringe. Obtaining an accurate dose can present difficulties using these methods: either by failing to load the correct dose onto a spoon, for example, or failure to administer the entire dose because a residual amount is left in the measuring cylinder, or the like. In addition, cleaning the equipment may pose problems in terms of effort required or access to suitable facilities for cleaning. In addition, particularly in relation to young children, the different doses required by infants and toddlers or older children may present difficulties in a family situation or day care centres, where it is necessary to administer medication to a number of children.

[03] There is a wealth of prior art in the fields of measuring and dispensing liquids. For example, US Patent No. 4,738,826 in the name of Arthur M Harris, discloses a system for precision reagent metering and delivery which relies on threaded engagement of a reagent container relative to a base, which causes longitudinal movement of a plunger so that a precise dose may be expelled directly from the reagent container. This is a complex system which relates primarily to automated dispensing systems used in industrial or commercial settings. Other prior art, such as US Patent No. 4,273,257 in the name of Sherwood Medical Industries Inc., relates to a pipettor with a reciprocating plunger with coarse and fine volume adjustment mechanisms. This is also a complex device with many parts.

[04] In coming up with the present invention, the inventor set out to provide a dose system which is easy to use and reduces the likelihood of accidentally administering an overdose of a liquid, such as a pharmaceutical preparation to a patient. In particular, the present inventor has produced a metered dose device which defaults to the zero after use. This means that a dose must be actively selected each time the device is used.

[05] The above references to and descriptions of prior proposals or products are not intended to be, and are not to be construed as, statements or admissions of common general knowledge in the art. Brief Summary of the Invention

[06] In a first aspect, the invention provides a metered dose device for dispensing a liquid preparation from a container, said device including: a) a dispensing chamber having an inlet means which allows liquid from the container into said chamber and an outlet means which allows the liquid to be dispensed from the device for administration, said chamber being of suitable volume to provide an incremental range of doses from zero to a maximum ; b) a dispensing means; and c) a metering means for measuring a selected dose into said chamber; wherein said metering means comprises: d) a movable member which controls dose volume available in the chamber and can be moved from a dose drawing condition to a dose dispensing condition such that the member and the chamber are engaged to allow a selected volume of liquid to be drawn from the container into the chamber and are disengaged to allow the liquid to be dispensed in cooperation with the dispensing means from the chamber, wherein disengagement resets the dose volume of the chamber to zero; and e) wherein said dispensing chamber and said moveable member cooperate with a closure body suitable for sealingly engaging an opening of a container.

[07] Preferably the liquid preparation to be dispensed is a liquid pharmaceutical preparation.

[08] The term "metered dose device" refers to a device capable of providing a measured dose of a preparation within an acceptable degree of accuracy and one that has been designed and produced in a way that ensures that the device provides accurate, precise and stable measurements within the specific limits and having regard to the intended purpose of the device. In the context of the device of the present invention preferably an acceptable degree of accuracy is a dose that is delivered with no more than +1-2% error of the specified dose.

[09] The term "a liquid pharmaceutical preparation" refers to any liquid pharmaceutical preparation including viscous preparations as well as gels and the like.

[1 0] The term "container" refers to any container that such pharmaceutical preparations are sold in and includes glass and plastic bottles.

[1 1 ] The term "dispensing chamber" refers to the chamber from which the dose is dispensed.

[1 2] The term "inlet means" refers to an appropriate valve and tubing , or the like. Valves include one-way valves, two-way valves, double-acting valves, or the like. [13] The term "outlet means" refers to a suitable valve to prevent backflow into the dispensing chamber such as a valve as shown in Figure 16 or the like.

[14] The term "an incremental range of doses" refers to a sequential range of doses, for example from 1 to 10 millilitres in one mL increments or from 5 to 50 millilitres in 5 mL increments.

[15] The term "dispensing means" refers to a piston or plunger or other suitable means operated by an actuator for expelling the dose from the dispensing chamber.

[16] The term "closure body" refers to the body of the device which may be provided as a closure for the container at the point of sale or could be provided separately. The dispensing chamber and moveable member cooperate with the closure body for sealingly engaging an opening of the container. In one or more embodiments the closure body forms the base of the device.

[17] The term "sealingly engaging an opening of a container" refers to the closure being able to provide a liquid tight seal for the container.

[18] In one or more embodiments, the metering means preferably includes a movable member in the form of a rotatable sleeve with a discontinuous thread arranged in a column which is engageable with a complementary discontinuous thread arranged in a column on the dispensing chamber.

[19] In one or more alternative embodiments, the moveable member may be removed. It follows that in a second aspect, there may be provided a metered dose device for dispensing a liquid preparation from a container, the device including:

a) a rotatable dispensing chamber having an inlet means which allows liquid from the container into said chamber and an outlet means which allows the liquid to be dispensed from the device for administration, said chamber being of suitable volume to provide an incremental range of doses from zero to a maximum;

b) a dispensing means; and

c) a closure body, wherein said rotatable dispensing chamber cooperates with the closure body for sealingly engaging an opening of a container and the closure body and wherein the rotatable dispensing chamber cooperates with the closure body to provide a metering means for measuring a selected dose into said chamber, wherein dose volume available in the chamber is controlled by rotation of the rotatable dispensing chamber relative to the closure body and the chamber can be moved from a dose drawing condition to a dose dispensing condition such that the rotating dispensing chamber is engaged with the container to allow a selected volume of liquid to be drawn from the container into the chamber and disengaged to allow the liquid to be dispensed in cooperation with the dispensing means from the chamber, wherein disengagement resets the dose volume of the chamber to zero.

[20] In this embodiment, the metering means may be provided by means of discontinuous thread arranged in a column on the rotatable dispensing chamber which is engageable with a complementary discontinuous thread arranged in a column on the closure body.

[21 ] Preferably the dispensing means includes a stationary piston where the rotatable sleeve moves in relation to the piston.

[22] Preferably one of the columns comprises a detent which upon rotation of the sleeve provides tactile and/or audible feedback to a user.

[23] The invention also includes a metered dose device of the first or second aspect for dispensing a liquid pharmaceutical preparation in combination with a container.

[24] There is also provided use of the metered dose device of the first or second aspect for dispensing a liquid pharmaceutical preparation.

Brief description of the Drawings

[25] The invention will now be described with reference to the following non-limiting drawings.

[26] Figure 1 is a partial side perspective view of the dose device in a dose drawing condition fitted to a bottle.

[27] Figure 2 is a vertical section through the dose device and bottle of Figure 1 .

[28] Figure 3 is a partial side perspective view of the dose device at the zero dose default position fitted to a bottle with the optional protective covering in exploded view.

Figure 4 is a vertical section through the base. [30] Figure 4b is a vertical section through the base in another embodiment. [31 ] Figure 5 is a side elevation of the measuring cylinder.

[32] Figure 6 is a vertical section through the partly assembled dose device showing the base, measuring cylinder and piston.

[33] Figure 7 is a side perspective view of the rotatable collar.

[34] Figure 8 is a vertical section through the rotatable collar of Figure 7.

[35] Figure 9 is a detailed view of a tapered thread.

[36] Figure 9b is a detailed view of a tapered thread in another embodiment. [37] Figure 10 is an underneath perspective view of the rotatable collar.

[38] Figure 1 1 is a vertical section through the partly assembled dose device of Figure 6 fitted to a bottle.

[39] Figure 12 is a vertical section through the partly assembled dose device showing the base, measuring cylinder, piston and rotatable collar fitted to a bottle.

[40] Figure 13 is a partial view of a vertical sectional through the cylinder cap and cylinder.

[41 ] Figure 14 is a side perspective view of the dose device in a dose drawing condition fitted to a whisky bottle.

[42] Figure 15 is a side perspective view of the dose device in a dose drawing condition fitted to a laundry detergent bottle.

[43] Figure 16 is an exploded view of a nozzle and valve as a dispensing tip for use in one or more embodiments of the invention with the cylinder cap.

[44] Figure 17 is a schematic diagram of the base provided with an internal thread which complements an external thread on the bottle. Detailed description of the Invention

[45] Metered dose device 100 is designed to fit onto an opening of a container such as bottle 200 containing a liquid pharmaceutical (not shown) optionally in conjunction with protective safety cover 300 to prevent accidental access.

[46] Dose device 100 comprises base 10, which supports measuring cylinder 30 and rotatable collar 50 at one end and has draw tube 70 at the other end which extends into the liquid pharmaceutical in bottle 200. Cylinder cap 80 on top of cylinder 30 is pressed to dispense the liquid. In one or more embodiments the rotatable collar 50 can be rotated in both a clockwise direction and an anticlockwise direction as required.

[47] Base 10 is a closure body which is cylindrical with a centrally located transfer passage 12 which runs through upstanding stator 13. Annular recessed portion 13a at the top of stator 13 is designed to receive piston 60. The lower end of transfer passage 12 has a larger diameter portion 12a to receive one-way valve 72 comprising valve seat 75 and valve ball 78. In one or more embodiments, one-way valve 72 may be replaced with another suitable valve such as a double- acting, two-way valve 72b as shown in Figure 4b. One-way valve 72 together with passage 12 comprises the inlet means. Although the one-way valve 72 is positioned at the lower end of transfer passage 12 in the drawings, it will be appreciated that the one-way valve can be positioned anywhere along the transfer passage 12 in the base 10. For example, in an alternate embodiment, the one-way valve 72 may be located at an upper end of the transfer passage 12 in the base 10. In this embodiment the upper end of the transfer passage 12 is provided with a larger diameter portion to receive the one-way valve 72 comprising valve seal 75 and valve ball 78.

[48] Sidewall 15, bottom wall 16 and stator 13 define annular cavity 18 of base 10 which cavity is coaxial about stator 13. Annular cavity 18 is of sufficient width and depth to accommodate part of rotatable collar 50 and measuring cylinder 30.

[49] Annular lip 19 of base 10 forms a rim at the top of sidewall 15 and is designed for a press fit into bottle 200. Locator recess 19a in lip 19 is for locking tab 59 described later. In an alternate embodiment, annular lip 19 is extended outwards and downwards to form a further sidewall 150 and further cavity 180 which is adapted to receive the neck 205 of bottle 200 (described further later). [50] Base 10 is made from PET (polyethylene terephthalate) but may be made from other suitable materials such as PPT, HDPE and HIPS.

[51 ] Measuring cylinder 30 is essentially a sleeve and comprises sidewall 32 with top end 35 and bottom end 37. Top end 35 has inside sidewall 32a with internal annular recess 35a suitable for seating cylinder cap 80 described in detail later. Bottom end 37 of sidewall 32 has discontinuous external collar threads 38 on outside 32b. Discontinuous threads 38 are arranged (or split) vertically into columns of four equally spaced groups spaced by four non-threaded column portions or gaps 38a. In one or embodiments, the measuring cylinder 30 can be rotated in both a clockwise direction and anticlockwise direction as required and can be moved up and down in relation to the base 10.

[52] Individual threads 39 are tapered having a pointed end and a blunt end. All threads 39 are oriented in the same direction. In one or more alternative embodiments, individual threads 39 may be replaced with threads which are tapered at both ends. In this embodiment, both tapers start from the same edge of the thread and all threads are oriented in the same direction.

[53] Cylinder 30 together with cylinder cap 80 provides the dispensing chamber.

[54] Cylinder 30 is made from PET but may be made from other suitable materials such as PPT, HDPE and HIPS.

[55] Dose volume markings V from 0 to10 mL are arranged vertically and are alternately offset down sidewall 32.

[56] Piston 60 comprises a disk with skirted edges 61 and central opening 63 of appropriate size to fit over annular recessed portion 13a of stator 13. In cross section piston 60 has an l-shaped configuration, skirted edges 61 being able to slidingly engage stator 13 and inside sidewall 32a of measuring cylinder 30 in a liquid tight manner.

[57] Piston 60 is made from elastomeric material such as polypropylene but may be made from other suitable materials such as thermoplastic elastomer (TPE) or thermoplastic rubber (TPR).

[58] Piston 60 and stator 13 form a plunger and together with measuring cylinder 30 provide a mechanism analogous to a syringe. Piston 60, stator 13, cylinder 30 and cap 80 (described in more detail later) provide a dispensing means. [59] Rotatable collar 50 is designed to fit over opening 206 of bottle 200. Rotatable collar comprises outer skirt 51 , top wall 52 and long inner skirt 53. Collar opening 55 is defined by top wall 52 joining long inner skirt 53. Collar 50 provides a metering means.

[60] Collar opening 55 is of suitable shape and dimension to accommodate measuring cylinder 30.

[61 ] Outer skirt 51 extends over the outside of bottle opening 206. Inside of outer skirt 51 has two circumferential ridges 51 a (best seen in Figure 8). These engage with circumferential grooves 210 on bottle neck 205 and allow collar 50 to rotate in clockwise and anticlockwise directions with respect to bottle 200 as described later. As described earlier, in an alternate embodiment, as shown in Figure 17 annular lip 19 of base 10 is extended outwards and downwards to form a further sidewall 150 and further cavity 180 which is adapted to receive the neck 205 of bottle 200). In this embodiment, the further side wall 150 is provided with an internal thread 160 which complements an external thread (circumferential grooves 210) on the bottle 200. In this embodiment, the further side wall 150 is of a shape which complements the circumferential ridges 51 a of rotatable collar 50. By use of this embodiment, the base 10 can be screwed directly onto bottle 200 in clockwise and anticlockwise directions.

[62] Outside of outer skirt 51 is basically square in shape with rounded edges. The straight sides of outside of outer skirt 51 have striations 51 b for easy manipulation. Position marker M1 is alignable with position marker M2 on bottle 200 as described later. Safety locking tab 59 is provided in opening 58 on one side of outer skirt 51 .

[63] Outside wall 53a of inner skirt 53 is smooth and adapted to fit snugly within sidewall 15 of base 10. Inside wall 53b of inner skirt 53 has collar threads 57 from top to bottom arranged in discontinuous threads in four equal columns of threaded column portions 56 and non-threaded collar column portions or gaps 56a. Each individual collar thread 57 is tapered with a pointed end and a blunt end similar to cylinder threads 39. As already described, in an alternative embodiment, each individual collar thread 57 may be replaced with individual collar threads tapered at both ends 57b (see Figure 9b), with both tapers starting from the same edge of the thread. Collar threads 57 are designed to engage with cylinder threads 39 and disengage with gaps 39a. The tapered ends of the threads facilitates alignment of the collar 50 as it is rotated in a clockwise or anticlockwise direction and vertically with respect to the base 10. [64] Collar 50 is indexed at quarter turn increments with each increment equating to 1 mil of liquid. Collar 50 has one column which has a smaller major diameter thereby forming detent 57a compared to the remaining three columns of threads (best seen in Figure 10). This creates an interference with the mating of the major diameter on the columns 38 of complementary cylinder threads 39. The interference creates some resistance which is alleviated once collar 50 is rotated past threads 38 on cylinder 30. The resistance created when collar 50 is rotated provides tactile feedback to the user. There is also an audible click. When the click is sensed this indicates to the user that the threads are disengaged enabling the liquid to be dispensed as described later.

[65] Bottle 200 had a suitable neck 205 and opening 206 to marry with dose device 100. Circumferential grooves 210 are arranged to engage with a circumferential ridges 51 a of collar 50 or in an alternate embodiment, internal threads 160 of the further side wall 150 of base 10. Marker M2 on shoulder of bottle 200 is alignable with marker M1 on collar 50. Neck 205 has rebate 205a and an adjacent opening 206 to accommodate part of locking tab 59.

[66] Cylinder cap 80 comprises nozzle 82, slanted top wall 85 from which sidewall 87 extends leading to open end 88. Nozzle 82 which protrudes from sidewall 87 is fitted with nozzle valve 82a which in this embodiment, is an elastomeric duckbill valve. It is contemplated that the valve may be disposable to prevent cross contamination particularly if the liquid pharmaceutical is dispensed directly to a patient rather than onto a spoon. Nozzle valve 82a may be replaced with other suitable valves other than a duckbill valve. For example, in an alternate embodiment as shown in Figure 16, nozzle 82 has a head portion including a portion of smaller radius 89 adapted to snugly fit with the rear body 90 of valve member 91 . A front body 92 is snap fitted to the rear body 90 thereby forming a cavity 93 in which is seated a double acting valve with integrated spring 94. As shown in Figure 16 disposable nozzle 95 fits onto the front body 92 via a bayonet style fitting. In an alternative embodiment the disposable nozzle may be fitted to front body 92 via 'ridge and groove' ring style fitting whereby the circular ridge around internal circumference of the disposable nozzle tip slots into a groove that runs around the circumference of the nozzle. In a preferred aspect the disposable nozzle is made from polyethylene (PE), although other suitable materials may be used. It is anticipated that the valve member, nozzle body and the disposable nozzle tip will be made from different materials to that of the disposable nozzle such as HDPE, PET and the like.

[67] Optional safety cover 300 approximates the shape of protruding parts of assembled dose device 200 including slanted top wall 85, nozzle 82 and collar 50. Safety cover 300 has channel shaped portion 305 to accommodate nozzle 82 and an open end which is engageable with the shoulder of bottle 200. Protective safety cover 300 is made of deformable material such that when squeezed from either side it can be released.

[68] Assembly of dose device 100 is performed by inserting ball 78 and valve seat 75 into portion 12a of transfer passage 12 on base 10 and fitting draw tube 70 onto valve seat 75. Measuring cylinder 30 is then inserted into annular cavity 18 of base 10. Piston 60 is then mounted on recessed portion 13a of stator 13. Base 10 thus assembled is inserted via a press fit into bottle 200 so that locator recess 19a is correctly spaced from marker M2.

[69] Locking tab 59 is placed into opening 58 on rotatable collar 50 which is then slid into place and retained by snap fit of circumferential ridges 51 a into circumferential grooves 210 on bottle 200 making sure markers M1 , M2 and rebates 19a and 205a are aligned.

[70] Cylinder cap 80 is fitted via circumferential ridges and grooves to top of measuring cylinder 30. Nozzle valve 82a is fitted onto nozzle 82. Nozzle 82 and valve 82a comprises the outlet means.

[71 ] Device 100 is brought into a dose drawing condition by sliding down locking tab 59 to release collar 50 which is then turned. The action of turning rotatable collar 50 allows collar threads 57 to engage with cylinder threads 38 thereby displacing cylinder 30 in an upward direction by moving over piston 60 which creates a liquid tight seal resulting in a vacuum causing liquid to be drawn up via draw tube 70 through one-way valve 72 up transfer passage 12 into measuring cylinder 30. Each quarter turn of collar 50 equates to drawing up 1 mL of liquid. The rotation of threads 38 in relation to threads 57 provides an audible click and a tactile sensation which provide added cues to the user.

[72] Once the required dose is drawn up a dose dispensing condition is achieved by aligning cylinder 30 such that threads 38 and 57 disengage. This is readily achieved by aligning markers M1 and M2. Downward force is then applied to cap 80. The tendency is for a user to press the cap all the way down which is made possible by the alignment of cylinder threads 38 with gaps 38a in collar threads 57. Depression of cap 80 results in measuring cylinder 30 being pushed down resulting in pressure which closes ball valve 72 at the bottom of base 10 and forces liquid to be ejected through nozzle 72. Pushing down on cap 80 to the fullest extent will expel substantially the entire dose. Importantly the indexed dose is reset to the zero which means that unlike in some systems which return to the previously selected dose, the system of the present invention addresses this issue by the user having to actively set the dose each time. The zero dose default on the dial-up system of the exemplified embodiment provides considerable safeguards. [73] As shown in Figures 14 and 15 the metered dose device 100 is designed for use in a wide range of dispensing environments such as, for example, dosed liquor and liquid laundry detergent.

[74] It will be seen from the above that the device of the present invention is easy to manufacture because it has relatively few parts. This is an added advantage.

Parts/Features List

Reference Feature/part name Reference Feature/part name symbol symbol

V Dose volume markings

M1 Position marker on collar 50

M2 Position marker on bottle

10 Base 80 Cylinder cap

12 Transfer passage 82 Nozzle

12a Widened portion of transfer 82a Valve

passage

13 Stator 85 Slanted top wall

13a Annular recessed portion of 87 Side wall

stator

15 Side wall 88 Open end

88a Circumferential rebate

16 Bottom wall 89 Portion of smaller radius

18 Annular cavity 90 Rear body

19 Annular lip 91 Valve member

19a Locator recess 92 Front Body

30 Measuring cylinder 93 Cavity

32 Sidewall 94 Double acting valve with integrated spring

32a Inside sidewall 95 Disposable nozzle

32b Outside sidewall

35 Top end

35a Internal annular recess 100 Metered dose device

37 Bottom end

38 Column of cylinder threads

38a Non-threaded column portions or

gaps

39 Individual cylinder thread

39a gaps 50 Rotatable collar

51 Outer skirt

51 a Circumferential ridges 63 Central opening

51 b Striations

52 Top wall

53 Inner skirt

53a Outside wall of inner skirt 150 Further side wall

53b Inside wall of inner skirt 160 Internal thread

55 Collar opening 180 Further cavity

56 Column of collar threads

56a Non-threaded column portions

(or gaps)

57 Individual collar threads 57b Individual collar thread

tapered at both ends

57a Collar detent (raised column of 200 Bottle

threads)

58 Opening for locking tab 205 Neck

59 Locking tab 205a Circumferential rebate

60 Piston 206 Bottle Opening

61 Skirted edges 210 Circumferential

grooves

70 Draw tube

72 One way valve 72b Two-way valve

75 Valve seat 300 Protective safety

cover

78 Valve ball 305 Channel shaped

portion

From the foregoing, it will be observed that numerous modifications and variations can be effected without departing from the true spirit and scope of the novel concept of the present invention. It is to be understood that no limitation with respect to the specific embodiment illustrated herein is intended or should be inferred. The disclosure is intended to cover, by the appended claims, all such modifications as fall within the scope of the claims. Throughout this specification and the claims that follow, unless the context requires otherwise the words "comprise", "comprises", "comprising" will be understood to mean the inclusion of the stated integer, step or group of integers or steps but not the exclusion of any of other integer, step or group of integers or steps.