WO1999032065A1

WO1999032065A1 - Method for providing individuals with an appropriate liquid formulation

Info

Publication number: WO1999032065A1
Application number: PCT/IL1998/000616
Authority: WO
Inventors: Michael Inbar; Igal Sharon
Original assignee: M.L.I.S. Projects Ltd.
Priority date: 1997-12-22
Filing date: 1998-12-17
Publication date: 1999-07-01
Also published as: AU1575399A

Abstract

A method for providing an individual with means of preparing a liquid formula to meet his exact needs, which is reconstituted from at least two ingredients, of which at least one of them is a liquid, is provided. The container with at least two compartments for individual storage of each of the at least two components is provided and then each compartment is filled with the appropriate amount of the respective component such that mixing of all the components with one another will eventually yield the required liquid formulation for the individual. The individual is then provided with this container to allow him to prepare his feeding formulation.

Description

METHOD FOR PROVIDING INDIVIDUALS WITH AN APPROPRIATE LIQUID FORMULATION

FIELD OF THE INVENTION

The present invention relates to a method and system for providing individuals with a liquid formulation which has a composition such that it meets the individual's specific needs. The formulation may be a nutritional formulation, e.g. for infants, babies or old individuals, a medicinal formulation, etc.

BACKGROUND OF THE INVENTION

Many formulations for human consumption are provided in the form of a liquid. This is the case for example, in feeding infants or babies. Another example is in the case of liquid medicinal formulations, particularly such provided to babies or children.

In many cases, liquid formulations are prepared by mixing liquid, e.g. water, with a dry particulate matter to form the liquid formulation. The dry particulate matter is typically provided together with instructions to mix a specified amount of the dry formulation with a specified amount of water to obtain a proper formulation. However, experience shows that in many cases the formulation which is eventually prepared by the individual is either too concentrated or too diluted. In both cases, this may have undesired consequences. In the case of medicinal formulation, a too diluted formulation will result in that the individual will receive, at each time, an amount of active ingredient less than needed. If the formulation is too concentrated, then the individual will obviously receive an overdose. The most widely used liquid formulations which are prepared by mixing dry matter with a liquid is the baby's or infant's feeding formula. Various surveys made show that very often feeding formulas are prepared incorrectly. J. Bennett et al. (Aust. J. Nutrition and Dietetics 47:1, 1990) mention that there is a substantial variability, as much as 100%, in the amount of powder measured by individuals in preparing the liquid formulation. They conclude that one possibility to tackle this problem is to provide powder in sachets containing known weights of powdered formula, which is then to be mixed with the known amount of water.

Lilburne et al. (Aust. Paediatr. J. 24:49-54, 1988) found that errors in reconstituting the liquid formula from the dry powder, compared with the manufacturer's instructions, were made by 100 surveyed mothers, consisting about 30% of the mothers. They further point out that in 52 cases (about half of those making errors) the errors were potentially serious, usually erring on the side of preparing an over-concentrated formula. Another problem associated with use of feeding formula is concerned with the purity and constituents of the water which is used to reconstitute the feeding formula. Water contains various minerals, which may vary in concentration from one location to the other. Further, the water may contain various substances such as lead (Haschke et al, Mineral Electrolyte Metab., 11:44, 1985) or nitrates (Kross et al, American Family Physician, 46: 183, 1992) which may be toxic to infants. The problem of water purity, particularly in developed countries, was also noted by Burghart (Medical Anthropology Quarterly, 10:63, 1996). Lilburne et al. (Supra) noted also that in many cases, the feeding formulas were contaminated with pathogenic microorganisms.

Formulas with concentrations higher than required may lead to various complications such as constipation. Diluted formulas may lead to malnutrition. Incorrect mineral content, the inclusion of various toxic substances and the lack of sterility of feeding formula may also have serious consequences. The practice to boil the water which is used for preparing the formula, provides only a very partial solution to only some of these problems.

GENERAL DESCRIPTION OF THE INVENTION

The present invention has as its object to provide the method and system which will provide an individual with a liquid formulation having a composition to meet his exact needs.

Other objects of the invention will become apparent in the text below.

The present invention provides a method for supplying liquid formulations to individuals in need of such formulations. The formulations dealt with by the present invention are such which are reconstituted, shortly before use, from at least two ingredients, of which at least one is a liquid. The invention involves a novel concept whereby a compartmentalized container is used, with the compartments being sealed from one another by a disruptable seal. Each compartment is filled by one component needed for reconstitution of the liquid formulation. The components are typically sterilized prior to their introduction into the respective compartments which may also be a priori, typically sterile. The amount of each component introduced into the container is such that the formulation which will eventually be reconstituted prior to use will have a composition meeting the exact needs of the individual. The containers may be provided in different unitary sizes, each with a different amount to fit the needs of a different individual. The invention is applicable for various applications. For one, the container may be a baby's or an infant's feeding bottle and the components will then be those required to reconstitute a liquid nutritional formula. By another example, the container is a medicinal container containing at least two components of a medicinal formulation which will then be used to reconstitute a medicinal formulation, e.g. a liquid antibiotic preparation. In accordance with the invention a failed-safe system is provided to allow home preparation of a liquid formulation which meets exact specifications (exact concentration of dry matter in a feeding formula, exact concentration of an active ingredient in a medicinal formulation, etc.). The container is typically made in a manner that the seal can be displaced, disrupted, broken, etc., by external manipulation, to allow mixing of the components so as to reconstitute the liquid formulation.

The term "reconstitute " should be understood as referring to the act of mixing the separately stored components (each in its compartment within the container) to form the liquid formulation.

In accordance with one of its aspects the present invention provides a method for providing an individual with means for preparing a liquid formula meeting the individual's needs which is reconstituted from at least two ingredients, at least one of which being a liquid, which have to be separately stored and mixed with one another prior to use, the method comprising:

(a) providing a container having at least two compartments for individual storage of each of said at least two components, which compartments are sealed from one another by a seal the integrity of which can be controllably impaired by a user to allow mixing of said at least two components with one another; the container having also a dispensing opening in flow communication with at least one of said at least two compartments; (b) filling each compartment with an appropriate amount of one of said components such that mixing of all components with one another will yield said liquid formulation for the individual; and

(c) providing the individual with the filled container. The invention further provides, by another of its aspects, a method for providing an individual with a liquid formulation containing needed ingredients at appropriate concentrations, comprising:

(a) providing a container having a dispensing opening, in at least two compartments, each for storing one component of a liquid formulation, at least one of which components being a liquid, the compartments being sealed one from the other by a seal, the integrity of which can be controllably impaired to allow mixing of the components, the dispensing opening being in flow communication with at least one of these components; (b) filling each of the compartments with one component of the liquid formulation in an amount such that when all components are mixed together, a liquid formulation will be formed with a concentration of the needed ingredients to meet required concentration; (c) providing the filled container obtained in step (b) to the individual; (d) opening the seal between the compartments and mixing all components to obtain a liquid formulation; and (e) administering the individual with said liquid formulation through the dispensing opening.

One preferred embodiment of the invention concerns the feeding of babies or infants. In this case, the liquid formulation is a nutritional formula and said container is a baby's feeding bottle. In this case the formulation is typically reconstituted from two components, one being a dry, water miscible, nutritional formula, the other component being water. The water will typically be sterile. The water may also be deionized and the entire minerals required for feeding will then be included in the dry formula. Where the water contains minerals, the mineral concentration of the liquid formula will typically be fixed such that the final concentration of the minerals in the feeding formula will be the concentration to meet the feeding needs of the infant or baby. It should be understood that the invention is not limited to the above preferred embodiment and includes also many other embodiments within the scope of the invention defined herein such as, in the case of liquid formulations to geriatric patients, medicinal formulations, etc.

In accordance with a preferred embodiment, the components of the liquid formulation which are included in the compartments are sterile. The container may undergo an initial sterilization step. e.g. by γ-irrdiation, by autoclaving, etc. The container may obviously be processed after its production in a manner which will ensure that its interior remains sterile until filling.

The process of introducing the components of the liquid formulation into the individual compartments, is preferably performed under aseptic conditions. However, it is possible, that rather than maintaining complete aseptic conditions, which may at times not be practical in the case of a large production plant, the containers, each with its contents, will be subjected to sterilization after filling such as by γ-irradiation, autoclaving, etc. In accordance with another aspect of the invention, there is provided a container with at least two compartments sealed from one another, which seal may be controllably opened, each of the compartments holding one component of at least two components of a liquid formulation which is reconstituted by mixing the at least two components, the amount of each component being such so as to yield after mixing a correct formulation to meet needs of the individual.

The container may have a variety of different forms depending on its intended purpose and the manner of use. Some examples of such container will be illustrated below. The invention will now be illustrated by a description of some specific, non-limiting embodiments, with occasional reference made to the annexed drawings:

BRIEF DESCRIPTION OF THE DRAWINGS

Fig. 1 is an exploded perspective view of a baby's feeding bottle in accordance with an embodiment of the invention;

Fig. 2 is a perspective view of the baby's feeding bottle of Fig. 1 with the cover removed; Fig. 3 is a perspective, partially cut-out view of the baby's feeding bottle in a storage position provided with a covering cap and holding two separately stored components of a liquid formulation;

Figs. 4A-4E show sequential steps in filling the baby's feeding bottle of the invention with two separately stored components, a liquid component and a powdered formula;

Figs. 5 A and 5B show steps in preparation of the baby's feeding bottle of Fig. 4 for feeding;

Fig. 6 is a side cross-sectional view of a two compartment container with a displaceable member fully tightened; Fig. 7 is a side cross-sectional view of a two compartment container of

Fig. 6 with the displaceable member partially released;

Fig. 8 is a schematic perspective view of the displaceable member of Fig. 6;

Figs. 9A-9C show sequential steps in filling of a medicinal container in accordance with an embodiment of the invention;

Figs. 10 A and 10B show steps in preparation of the formulation stored in the container of Fig. 9 for dispensing; Figs. 11A-11F show steps in preparation of a formulation for dispensing in a medicinal container in accordance with another embodiment of the invention, comprising a formulation dosing arrangement;

Figs. 12A-12E show sequential steps in the preparation for dispensing of a medicinal formulation stored in a container in accordance with another embodiment of the invention, with a different dosing arrangement;

Fig. 13 A shows a side view of a bottle in accordance with another embodiment of the invention;

Figs. 13B and 13C show a longitudinal cross-section through the bottle of Fig. 13 A, where Fig. 13B is in a state where the partition wall seals the two compartments and Fig. 13C is in a state where the partition wall is displaced to allow communication between the two compartments;

Figs. 14A-14C show a longitudinal cross-section through a baby's feeding bottle in accordance with another embodiment of the invention, wherein Fig. 14A is in a state where the two compartments are sealed from one another, Fig. 14B is in a state where the partition wall is moved providing for communication between the two compartments; and Fig. 14C is an exploded view of the container of Figs. 14A and B;

Fig. 15 shows s longitudinal cross-section through a two-compartment container in accordance with a baby's feeding bottle embodiment of the invention;

Figs. 16A-16F illustrate the manner of filling of the baby's feeding bottle of Fig. 15 to store different components of a baby's formulation one in each compartment, and then breaking the partition wall between the compartments and mixing the two components to form the formulation prior to use;

Fig. 17 is a longitudinal cross-section through a baby's feeding bottle in accordance with another embodiment of the invention; and Fig. 18 shows a baby's feeding bottle of Fig. 17 in use when mixing the two components into final formulation and preparation for use.

DETAILED DESCRIPTION OF A SPECIFIC EMBODIMENT The below described embodiments relate to containers of the present invention, typically baby feeding bottles, having two compartments, one containing a powdered formula and the other containing a fluid, for example, water. Also described below are examples of uses of the bottles within the framework of an embodiment of the invention concerned with feeding of infants. The following description is provided to illustrate various specific configurations and examples and the invention should not be regarded as being limited to these embodiments. The features of the invention may also be used for different uses, e.g. two or more compartment containers for medicinal formulations, dietary powders to be reconstituted with a liquid, alcoholic beverages to form cocktails with other ingredients, wherein one compartment contains one component and the other compartment contains another different component to be mixed to form a formulation.

While the container of the present invention is generally described as holding a dry powder component and a liquid component, the two components may be both liquids, both fluids, one may be a liquid (or a fluid) and the other may be a dry formulation or both may be dry formulas. In describing the invention the substances stored in the container have been described using the terms, "components ", "constituents ", "materials ", "substances " and the like, interchangeably. A baby's feeding bottle 10 has a general cylindrical housing 12 with an opening 14 and a constricted neck portion 16. The neck portion 16 in part defines and divides the housing 12 into what will become a first compartment 18 beneath said neck portion and a second compartment 38 (see Fig. 3) above the neck portion. The container holds a displaceable member generally designated 20 which has a partition wall 22 with an edge 24 (see Fig. 3) adapted for fluid-tight sealing engagement with internal walls of neck portion 16. The fluid-tight sealing engagement in this specific embodiment is ensured by means of a peripheral O-ring 28 fitted into an annular groove 29 provided in edge 24, although other means such as geometry and shape of edge 24 and neck portion 16 as well as materials of construction can also be used to provide the fluid-tight seal.

The partition wall 22 depends from and is connected to a manipulable portion 30 by means of one or more downward projecting stems 32 which form a connecting wall portion. In this embodiment, three radially directed stems 32 connect partition wall 22 to the manipulable portion 30. In the case of a single stem, it will typically be central, and in the case of a plurality of stems, it will typically be disposed in the periphery. In another example, the partition wall and the manipulable portion may be connected by a peripheral wall formed with openings. In a further example, the connection between the partition wall and the manipulable portion is by means of radial wall sections. Opening 14 is provided with external threading 34 at its periphery for screw-engagement with internal threading 36 in displaceable member 20. The manipulable portion 30 has a fillable aperture 31 through which the contents of the container can be dispensed, or materials added to the container. Connecting wall portions 32, also referred to as stems, are provided with or arranged with openings 35 communicating with aperture 31 so that a passageway or conduit through displaceable member 20 is formed so that materials can be passed between the interior and exterior of housing 12.

In the specific example shown in Figs. 1-3, when the displaceable member is fully screwed onto opening 14, the partition wall comes to a sealing engagement with internal walls of neck portion 16, as can be seen particularly in Fig. 3. In this position of the partition wall, referred to as "first state ", the partition wall forms two compartments, a first compartment 18 below said partition wall and a second compartment 38 between said partition wall 22 and said opening 14. In the first state, at least a portion of the partition wall forms at least a portion of a common wall shared by both compartments. Upon rotation of the displaceable member in a counter-wise manner, the partition wall 22 is axially displaced towards the opening 14, disengaging the internal walls of neck portion 16, thus allowing communication between the two compartments, referred to as the "second state ".

The baby's feeding bottle 10 has a nipple 42 which is fastened to a top end of the displaceable member 20 by means of a nipple retaining ring 44 which is snap fitted into a receptacle 46 at a top end of displaceable member 20. The baby's feeding bottle shown herein further has a cap 48 which has a cylindrical portion 50 which snugly engages the outer upper surface 52 of displaceable member 20. Cap 48 may be configured to seal opening 64 provided in the nipple 42 and protects the nipple's sterile condition. In addition, a seal made of aluminum foil, for example, may be provided over opening 14 or aperture 31 to prevent the components or mixed formula from exiting the container before desired. External face 52 of displaceable member 20 has an axial groove 54 which cooperates with a radial inwardly facing projection 56 in cap 48. By virtue of this engagement, when cap 48 is rotated, this leads to rotation of displaceable member 20 and hence to its axial displacement.

The bottle 10 may be particularly constructed for a single use through a variety of ways such as, for example, using a thin plastic material for the housing, or nipple retaining ring 44 may be made so that it cannot be removed so that the nipple is not removable and thus the container cannot be refilled, or the nipple retaining ring 44 and the top end of the displaceable member 20 may be configured and adapted such that if nipple retaining ring 44 is removed it or a replacement cannot be refastened on the container so that the nipple can no longer be held on the container, or the displaceable member can be configured and adapted so that once it has moved from its sealing position it can no longer reform a fluid-tight seal. It is envisioned that either one or a combination of these can be used in a single embodiment.

In the specific embodiment shown in Fig. 3, the first compartment 18 of the baby's feeding bottle holds a liquid 60, e.g. sterile water, and the second compartment 38 is filled with a powdered formula component 62. It is envisioned that the materials may be reversed and the first compartment 18 hold the powdered formula component 62 and the second compartment 38 hold the liquid. The manner of producing a baby's feeding bottle of the kind shown in Figs. 1-3 is shown stepwise in Fig. 4. As will be appreciated, the manufacture is preferably performed under aseptic conditions using sterile components to ensure the bottle's sterility. In the first step of manufacture, as shown in Fig. 4A, a first component, for example, liquid 60, typically sterile water, is introduced into housing 12 by a dispensing nozzle 63 opening sterile water from sterile water continer 63A. The first component is preferably inserted without the displaceable member positioned on the housing, however the first component may be inserted with the displaceable member positioned on the housing. For example, the first component can be introduced with displaceable member positioned on the housing and in the second state so that the first component is permitted to pass to the first compartment, or the displaceable member may be in the first state and thereafter axially displaced to the second state before the second component is added so that the first component can pass to the first compartment. As a next step, shown in Fig. 4B, the displaceable member 20 is screw- fitted onto the opening 14 of the housing whereby the partition wall 22 comes into a sealing engagement with internal walls of neck portion 16. At a next step, shown in Fig. 4C, a second component, for example, sterile powdered formula 62 is introduced by dispensing nozzle 65 fed formula from sterile container 68A, into the second compartment 38 through aperture 31 and opening 14. This is then followed by sealing the aperture with nipple 42 by means of retaining ring 44 (Fig. 4D) and then placing cap 48 over said nipple (Fig. 4E). In this position cap 48 seals opening 64 in the nipple 42. When preparing a baby's feeding bottle in accordance with the invention in a manufacturing plant, the use of good quality water may be ensured. Good quality water can be defined by the concentration and composition of minerals, the lack of contamination such as heavy metals, bacteria, micro-organisms and other hazardous materials and can be achieved by water purification, e.g. by distillation. Exact amounts of powdered formula and liquid can be achieved by factory automation so that the proper ratio and mixture of components is ensured, thus providing an optimal mixture that is neither too diluted nor too concentrated.

The entire process shown in Fig. 4 is typically performed under aseptic conditions.

Fig. 5 shows the manner of preparing to use the baby's feeding bottle. In a first step (Fig. 5A), the displaceable member 20 is rotated whereby partition wall 22 is axially displaced whereby its edges disengage the inner walls of neck portion 16. In this position (the "second state ") the two compartments (the first and the second compartment) come into flow communication with one another. This raises partition wall 22 away from neck portion 16 allowing, second component 62 to drop down into first compartment 18. In this state, cap 48 is retained on the housing such that the mixture and nipple 42 remain sterile. By agitating, shaking or turning, represented by arrow 68, the dry formula 62 and liquid 60 are mixed with one another to yield liquid formula 70. By removing cap 48, the liquid formulation can be dispensed through opening 64 of nipple 42. By ensuring exact amounts of the water 60 and the powdered formula 62, an exact desired liquid formulation with a concentration of ingredients meeting well defined specifications can be obtained.

Figs. 6 and 7 show another embodiment of a two-compartment container, generally designated 310, in which an intermediate seal is controlled externally by rotation of a threaded displaceable member. Two-compartment container 310 includes a housing 312 having a constricted neck portion 318 which defines a first compartment 314 and a second compartment 316. First compartment 314 and second compartment 316 intercommunicate at constricted neck portion 318. Second compartment 316 has an opening 320 which has a threaded portion 322 around its periphery.

Two-compartment container 310 also includes a plug element or displaceable member 324 which is shown separately in detail in Fig. 8. Displaceable element 324 has a threaded part 326 for rotatably engaging threaded portion 322 and a partition wall 328 for sealing neck portion 318. Displaceable member 324 is formed such that, when it is rotated and threaded part 326 interacts with threaded portion 322, partition wall 328 moves from a non-sealing position (second state) as shown in Fig. 7 in which first and second compartments 314 and 316 intercommunicate to a sealing position (first state) as shown in Fig. 6 in which neck portion 318 is sealed.

Typically, partition wall 328 is formed to complement neck portion 318 and includes a resilient O-ring seal 334, formed from silicone rubber or the like, clipped between opposing pieces of a molded plastic assembly. Alternatively, planar or otherwise shaped abutment surfaces may be provided for sealing neck portion 318. The fluid-tight seal formed by the partition wall with the neck portion may be reformable, i.e. the two compartments are resealable. Alternatively, the partition wall and neck portion may be configured so that the seal is not capable of being reformed. In a preferred feature of certain embodiments of the present invention that displaceable member 324 also feature at lest one conduit 330 for allowing introduction of a component through opening 320 into second-compartment 316 when displaceable member 324 is in its sealing position. The at least one conduit 330 is preferably circumscribed by threaded part 326 of displaceable member 324. Thus, displaceable member 324 as shown features a substantially cylindrical threaded part 326 with four conduits 330 separated by longitudinal radial walls. The longitudinal radial walls connect the partition wall 328 with the threaded part 326. Alternatively, the conduits may be formed peripheral to displaceable member 324 as flutes or channels in the threaded wall (not shown). Two-compartment container 310 in this case also includes a secondary seal 332 for sealing conduits 330. In a further alternative implementation of the present invention (also not shown), displaceable member 324 may be of a solid construction. In this case, a separate sealable opening is provided to allow filling and/or dispensing of second compartment 316.

It is a particular feature of some embodiments of the present invention that displaceable member 324 may be moved or rotated to selectively seal or unseal neck portion 318 from the outside of two-compartment container 310. To allow displaceable member 324 to be gripped for this purpose, displaceable member 324 may feature an upper wall section 336 extending beyond threaded part 326. Manual rotation of displaceable member 324 is facilitated by a flange member 338 which is attached around the outside of upper wall section 336. The assembly and filling procedure of two-compartment container 310 is essentially the same as that described with reference to bottle 10 and Figs. 4-5.

Specifically for infant formula feeding applications, the two-compartment container preferably also serves as a feeding bottle. To this end, the two-compartment container is provided with a feeding nipple attached around the outside of the displaceable member. In the case of Figs. 6 and 7, flange member 338 may be mounted externally to feeding nipple 340 and secondary seal 332 may be external to both. This allows secondary seal 332 to serve multiple functions, sealing second compartment 316, protecting the sterility of feeding nipple 340 and attaching to a shoulder of second compartment 316 so as to act as a tamper-indicating wrapping to ensure that flange 338 has not been twisted open.

Figs. 9A-9C show the construction and steps in filling of a two compartmental container 80 in accordance with a different embodiment of the invention. Container 80 is formed from a generally tubular body 82 with an opening 84 at an end of the body constituting the bottom of the container and a second opening 86 at an opposite top end. Intermediate between the top and bottom ends is a constricted neck portion 88. While containers 10, 310 and 80 have been formed with a constricted neck portion, the neck portions of these containers may also be formed as described with reference to Fig. 13.

Displaceable member 90, having an end wall 92 with a sealable filling aperture 94 and a partition wall 96 dependent from end wall 92 by stems 98, is fitted at end 84 by screw-threading at its peripheral portion 100. As a result of this screw-threading, the displaceable member 90 rotates causing axial displacement of partition wall 96 with respect to neck portion 88. After engagement of displaceable member 90 with body 82, and in particular partition wall 96 forming a fluid-tight seal with neck portion 88, a first component 101, e.g. water, is introduced through aperture 94, which is then sealed by stopper 102. The container is then rotated into the position seen in Fig. 9B, with opening 86 facing upward. Then a second component 104, e.g. a powdered formula, is introduced through opening 86 which is then sealed by closure assembly 106. Closure assembly 106 may be provided with resealable closure 108. Preparing the container of Figs. 9A-9C for use and dispensing of the formulation is shown in Figs. 10A and 10B. In a first stage, shown in Fig. 10A, the displaceable member 90 is rotated such that partition wall disengages neck portion 88 to allow mixing of components 101 and 104 to yield liquid formulation 110. After mixing and homogenization, the container may be rotated for dispensing through closure 108 as shown in Fig. 10B.

Another embodiment of container 120 is shown in Figs. 1 1A-11F. Container 120 is similar to container 80, shown in Figs. 9 and 10, and so is its manner of filling, with a difference residing in assembly 122 which allows dosing of the liquid formulation 124.

Figs. 11 A through 1 IF show different steps in the preparation and dispensing of the formulation. Assembly 122 defines a compartment 126 formed between a lid 128 and a bottom wall 130 of the assembly 122. Lid 128 forms a fluid-tight seal with the top end of the assembly. The assembly 122 has a skirt 132 which screw engages with screw thread 134 at the opening of a container 120. The assembly further has openings 136 which in the position shown in Figs. 11A-11C, provide for communication between compartment 126 and interior space 138 of container 120.

After mixing the two components, as shown in Fig. 11B, the container is rotated and consequently the liquid formulation fills compartment 126 through openings 136 (Fig. 11C). The assembly 122 is then rotated so that openings 136 are closed (Fig. 1 ID) and the container 120 can be turned upright (Fig. HE). The side wall 131 of the closure assembly forms a reformable fluid-tight seal with the housing to prevent the liquid formulation or any of the separate components from leaking from the container. O-rings 133 may be provided to form or assist in forming the fluid-tight seal. Then the lid 128 can be removed and the contents of compartment 126 may be dispensed (Fig. 1 IF). Another embodiment of a container 150 is shown in Figs. 12A-12E. Here again, this container 150 differs from containers 80 and 120 in the nature of the closure and dosing assembly 152. The manner of dosing is shown in Figs. 12A-12E. The dosing assembly 152 has an end wall 155 with a depending skirt 153 along its peripheral edge which has screw threads 151 which engage cooperating screw threads 154 on the opening of container 150. End wall 155 has an aperture 156 which is fitted with a cylindrical central pipe 158. A fluid tight seal is provided between central pipe 158 and end wall 155 so that neither the components nor mixed liquid formulation leaks from the container. Central pipe 158 opens into and communicates with a dosing compartment 157. Compartment 157 is sized to hold an appropriate and predetermined amount of liquid formulation. The top side of compartment 157 is formed with a number of small holes 159 which are configured to allow the liquid formulation to enter and be trapped in the dosing compartment 157. Cap 149 is provided on central pipe 158 and provides a fluid tight seal.

In Fig. 12 A, the twoOcompartment container separately stores the two components, in this case a dry powder in the top compartment and a liquid in the bottom compartment, until the liquid formulation is to be prepared. When the liquid formulation is to be prepared, the displaceable member is moved so that the top and bottom compartments intercommunicate as shown in Fig. 12B. The entire container may be moved, such as for example, by shaking or agitating, to facilitate the preparation of the liquid formulation. In Fig. 12C, the container is turned upside down and the liquid formulation flows through small holes 159 into the dosing compartment 157. When dosing compartment 157 is full, the container is then turned back into its upright position as shown in Fig. 12D. Cap 149 is thereafter removed and the liquid formulation is dispensed through central pipe 158 as shown in Fig. 12E. Since central pipe 158 has a much larger cross-section and opening than do all of small holes 159, the dosage amount in dosing compartment 150 is dispensed in Fig. 12D before small holes 159 allow additional liquid formulation into dosing compartment 157.

Another embodiment of a container 160 is shown in Figs. 13A-C as a baby's feeding bottle 160 having a body 162 and a bottom end 164. A displaceable member 170 is formed with a bottom portion 172 having a central opening 174 sealed by a stopper 176 and having a partition wall 178 connected to the bottom portion 172 by means of a cylindrical wall 180 formed with openings 182. Instead of a constricted neck portion, housing 162 has an inwardly extending radial wall 184 defining a neck portion 185 which cooperates with partition wall 178 to provide fluid-tight seal between a top compartment 190 and a bottom compartment 192 in the state shown in Fig. 13B. In Fig. 13, housing 162 accommodates a sleeve 183 which at its top end has inwardly extending radial wall 184 which cooperates with a sealing annulus 186 on partition wall 178 to form the fluid-tight seal. The seal may be reformable (i.e., it is resealable) or be constructed to form a seal which cannot be reformed after the partition wall disengages from the neck. The displaceable member is axially displaced to the position seen in Fig. 13C so that compartments 190 and 192 come into fluid communication with one another. The liquid formulation may then be mixed and dispensed through the nipple closure arrangement which may be constructed as described above or according to manners known in the art.

Bottom end 164 in Figs. 13A-C is formed with a helical groove 166. Groove 166 slidingly accommodates a knob 168 which causes axial displacement of displaceable member 170 by rotation of the knob 168 between a first position, marked by the word "OFF", where the knob is positioned in Fig. 13 A and 13B, and a second position, marked by the word "ON", seen in Fig. 13 A. Details may be provided in groove 166 to retain knob 168 in either the "on " or "off" position. A different embodiment of a baby's feeding bottle 200 is shown in Figs. 14A-B having a housing 202 which is generally cylindrical and has a constricted neck portion 204. Inwardly projecting from neck portion 204 is an annular engagement member 206 formed with a downwardly-facing groove 208 which cooperates with an annular projection 210 projecting from a partition wall 212 to provide a fluid-tight seal between a bottom compartment 214 of the container and a top compartment 216 as shown in Fig. 14A. The partition wall 212 forms part of a displaceable member 218 which has a user manipulable portion 220 with two pins 222 accommodated within a helical groove 224. By rotation of the user manipulable portion 220, the displaceable member is acially displaced downwardly to the position shwon in Fig. 14B.

The displaceable member further has a bottom portion 226 having an opening sealed with a stopper 228. The partition wall 212 is connected to the bottom portion 226 by a cylindrical wall 225 having openings 227. The stopper 228 allows a component, e.g. powdered baby formula, to be introduced into a bottom compartment 214. The baby's feeding bottle 200 has an opening 238 fitted with a nipple 230 with the nipple being protected by a cover 232 which may be attached to the housing by a snap fit or cooperating threaded portions. The top compartment 216 in the embodiment of Figs. 14A and 14B is specifically sized to store the liquid and/or fluid substance while the bottom compartment 214 is sized to store the dry substance. It is envisioned that certain advantages and better mixing may result from the liquid and/or fluid being added to the dry substance in the lower compartment. For example, storing the powder in compartment 216 can lead to blockage of the nipple by undissolved powder.

In Fig. 14C an exploded version of Figs. 14A-B is shown. Housing 202 is constructed by assembling main tank 250, having neck portion 204 and inwardly projecting annular engagement member 206, with nipple seat 260 by ultrasonic welding so that main tank 250 and nipple seat 260 form fluid tight compartment 216. The opening 238 in the top end of the housing 202 is fitted with nipple 230 which is held in place by a nipple clamping ring 240. The nipple clamping ring 240 mates with a shoulder 234 formed on the nipple 230 and is held in place by proturbences 236 formed on the nipple 230 and by lip 262 formed on nipple seat 260. The nipple clamping ring 240 couples the nipple 230 to the container by being snap fitted over lip 262.

The assembly of nipple 230 on housing 202 with nipple clamping ring 240 is designed so that the container is for a single use. For example, nipple clamping ring 240 can be designed to snap onto lip 262 in a manner so that if the ring is removed, it cannot be refastened to the container. Alternatively, or in addition, to, nipple clamping ring 240 can be designed to snap onto lip 262 in a manner so that if the ring is removed, it cannot be refastened to the container. Alternatively, or in addition to, nipple clamping ring 240 can be designed so that it cannot be removed after it has been snap fitted into place on the nipple seat 260. Other attributes of the container which make it particularly adaptable for a single use are its materials and ease of construction, and the thickness of materials used. Fig. 14C also shows displaceable member 218 with manipulable ring portion 220. Displaceable member 218 is inserted within the bottom end of housing 202 and manipulable portion 220 is fitted over the bottom end of the housing 202 and positioned so that pins 222 are insertable within helical groove 224 and are snap fitted through apertures 225 in displaceable member 218 to attach the manipulable portion 220 to the displaceable member. Depending upon whether the container is for a single use or multiple use the seal formed by the annular projection 210 (on partition wall 212) and groove 208 (on annular engagement member) can be designed to form a one use seal or a reformable seal (i.e., resealable). In some applications it may be desirable to have the container specifically constructed for a single use so the sterility of the container (and nipple arrangement) and the correction proportions, sterility and quality of the components are ensured. In the embodiment of Figs. 14A-C the annular projection 210 and groove be configured and adapted for a single use such as by, for example, ultrasonically welding the two together wherein the welded joint pulls apart upon movement of the displaceable member 218. The annular projection and groove may also be configured and adopted to be resealable, that is, the seal can be broken and reformed by movement of the displaceable member. It will be appreciated that filling of the container of Figs. 13 and 14, etheir preparations for use and dispensing is similar to the embodiment described in Figs. 9A-C and 10A and B.

A baby's feeding bottle 410 according to another embodiment of the invention is shown in Fig. 15. The container comprises a housing 412 of a general cylindrical shape with side walls 414, a bottom wall 416 and an opening 418 at its top fitted with a closure assembly 420. Fixed at the bottom end of the container is a tamper-resistant cover 421, the function of which will be explained further below.

Closure assembly 420 comprises a nipple 422, typically made of silicon rubber, latex rubber or any other FDA approved material adaptable for such purposes, having an annular skirt 424, mounted on a sealing member 426 having an annular portion 428 defining a central aperture 429 fitted with a sieve element 430 for filtering out undissolved food particles from the liquid formula, and having an upwardly extending cylindrical annulus 431 supporting the bottom inner face of nipple 422 and slanted support structure or legs 432. The edges of annular portion 428 are received in peripheral circumferential shoulder 434 at the top end of side walls 414. The nipple is held by an engagement member 436 having generally a stepped cross-sectional shape. The engagement member 436 has a first horizontal portion 442 pressing on skirt 424, a second annular horizontal portion 444 resting in peripheral recess 446 of seat member 426, and a peripheral downward extending portion 448 snappingly engaging shoulder 434 by means of annular bulge 450. This manner of engagement by means of engagement member 436 ensures a fluid tight attachment of the closure assembly 420 to opening 418. The fluid tightness of the engagement may at times be improved by the use of a rubber annulus placed below horizontal portion 444, etc.

As described with reference to Figs. 14A-C, the nipple assembly can be configured and adapted so that the container is particularly suited for a single use, such as by for example, designing the engagement member to be unremovable or not capable of being refastened.

As can further be seen in Fig. 15, closure assembly 420 is fitted with cover 452 having a downward projecting cup member 454 receiving the top end of nipple 422 thus sealing its opening 456. The container has two compartments, a top compartment 460 and a bottom compartment 462 separated by a partition wall 464 integrally connected to side walls 414 through annular connecting zone 466. Extending downward from partition wall 464 is an elongated connecting member 468 having a hollow cavity 470 with an opening 472 at its top end and having reinforcing ribs 474. The bottom end of elongated member 468 is received by and connected to a cup member 476 projecting upwards from bottom wall 416.

Partition wall 464 provides a fluid tight separation between compartment 460 and 462. Upon vertical displacement as a result of upward pushing of bottom wall 416, the connecting zone 466 breaks thereby unifying the two compartments and allowing mixing of their contents. The seal formed in this embodiment by partition wall 464 is not reformable and the container is particularly adapted for a single use. In order to avoid accidental displacement of bottom wall 416, it is covered by tamper-resistant cover 421 which has to be removed to allow pushing of bottom wall 416. The tamper-resistant cover 421 may be removably attached by using of snap-fit arrangement, by screw coupling, by a tearable attachment zone, etc. Alternatively, the tamper-resistant cover may also be a foil or a film removable prior to use.

Figs. 16A-16E illustrate the manner of preparation of the container, so that each compartment contains one component of a baby's feeding formula, e.g. sterile powdered formula in the bottom compartment 462 and sterile water in the top compartment 460. However, this may obviously be reversed, i.e. the powdered formula at the top and water at the bottom. The container is typically provided initially in the manner shown in fig. 16A without bottom wall 416 and closure assembly 420 and placed inverted. At a first step, shown in Fig. 16B, compartment 462 is filled with a dry powdered formula 490 introduced through the opening end 492 via a dosing dispenser 94. At a next step, shown in Fig. 16C, the bottom wall 416, having a concave shape within annular skirt portion 496, is mounted over the open end 492 of the container and attached thereto. Preferably, the annular skirt portion 496 is attached to the internal face of wall 412 by sonic welding, although other forms of adherence are also possible such as gluing, or heat welding, etc. Cup member 476 is then fixed to a bottom end of elongated member 468 by sonic welding typically performed by inserting a probe 497 through opening 418 of the container and opening 472 of cavity 470.

In the next step of preparation, shown in Fig. 16D, a tamper-resistant cover 480 is mounted over end 492 and the container is turned into its upright position and liquid (typically sterile water) 498 is introduced into compartment 460 through a dispensing tap 400. Then, in a next step, shown in Fig. 16E, the closure assembly 20 is fitted over opening 418.

Preparing the container for use is shown in f g. 16F. Prior to use, the tamper-resistant cover 480 is removed from the bottom end of the container and force is applied in a vertical direction on bottom wall 416, as represented by arrow 404, causing the wall 416 to assume the position seen in Fig. 16F, yielding a vertical axial displacement of elongated member 468 and partition wall 464. This tears or breaks the partition wall 464 at the connecting zone 466 whereby the contents of the two compartments can be mixed (represented by arrows (404). After mxing, the formulation is ready for use and dispensing through opening 456 of nipple 422 after removal of cap 452.

Reference is now being made to Fig. 17 showing a baby's feeding bottle 510 in accordance with another embodiment of the invention. This embodiment is in essence similar to the embodiment shown in Fig. 15 with all like elements given a reference numeral and the two last digits being the same as the corresponding element in Fig. 15. In distinction from the bottle of Fig. 15, the bottom wall 516 in Fig. 17 is upwardly arcuated having integral handle 580 confined within a space defined by the bottle's base member 582.

As shown in Fig. 18, when the handle 580 is pulled downward in the direction of arrow 586, wall 516 becomes downwardly arcuated with the displacement causing breaking or tearing of connecting zone 566 allowing mixing of the contents of the two compartments, similarly as in the embodiment of Figs. 15 and 16. Handle 180 has several engagement teeth 584 which serve, as can be seen in Fig. 17, for engagement with accessory wall 588, to hold a bottom wall 516 in the downward-arcuated position. Once the contents of the two compartments have been mixed, and a ready-to-use formation is formed, it can be dispensed through openings 556 of nipple 522 after removal of cap 552.

It should be appreciated that the present invention may be used to advantage for a wide range of implementations of two-compartment containers. Possible implementations include, but are not limited to, food, beverage and pharmaceutical applications, and may employ two liquid components or one liquid and one solid component. It further should be appreciated that in some embodiments the invention may also be particularly directed toward single use, pre-packaged two or more compartment containers which are easily and inexpensively constructed and filled so as to be disposable.

The container may also feature accessories specific to a given application for dispensings of the final mixture. Possibilities include, but are not limited to, feeding devices designed for infants or geriatrics and measuring cups or other devices for dispensing measured units for medicines and the like. By way of example only, the present invention has in some examples been illustrated herein with respect to an infant formula feeding bottle structure and in other examples to a dairy assembly. It is significant to note that the containers of the present invention may be filled under a wide range of controlled conditions suited to a wide range of applications. The entire assembly process may be performed under sterile conditions and may use sterilized components and ingredients. In addition, one or both of the compartments, and particularly the compartment containing a powdered ingredient, may be partially evacuated. Alternatively, or additionally, an inert gas such as Nitrogen may be introduced, either above or below atmospheric pressure, to minimize oxidation of the contents during storage. Other special environmental conditions such as controlled humidity may also be employed as required. Furthermore, the container may undergo a sterilization step, e.g. by autoclaving or by γ-irradiation, either prior to introducing the ingredients therein or thereafter.

In cases such as infant formula in which the mixture may need to be warmed to enable dissolution or for dispensing, the two-compartment container may be made entirely of non-metallic materials to allow direct heating of the contents in a microwave oven. Alternatively, or in addition to, the two-compartment container may be made entirely of materials to allow heating of the contents by placing the container in boiling or heated liquid such as water. Many materials may be used in the construction of the different embodiments of the invention including plastics such as, for example, polypropylene. The feeding nipple and portions of the partition wall may be made of silicon rubber. When used to store or dispense medicines and food, it is contemplated that the materials of the container meet regulatory standards such as provided by the United States Food and Drug Administration and other regulatory authorities.

It will be appreciated that the above descriptions are intended only to serve as examples, and that many other embodiments are possible and encompassed within the spirit and the scope of the present invention.

Claims

CLAIMS:

1. A method for providing an individual with means for preparing a liquid formula meeting the individual's needs which is reconstituted from at least two ingredients, at least one of which being a liquid, which have to be separately stored and mixed with one another prior to use, the method comprising:

(a) providing a container having at least two compartments for individual storage of each of said at least two components, which compartments are sealed from one another by a seal the integrity of which can be controllably impaired by a user to allow mixing of said at least two components with one another; the container having also a dispensing opening in flow communication with at least one of said at least two compartments; (b) filling each compartment with an appropriate amount of one of said components such that mixing of all components with one another will yield said liquid formulation for the individual; and (c) providing the individual with the filled container.

2. A method according to Claim 1, wherein said formulation is a nutritive formulation.

3. A method according to Claim 1, wherein said formulation is a pharmaceutical formulation.

4. A method according to Claim 2, wherein said individual is a bottle-fed baby, infant or neonate, said container is a compartmentalized baby's feeding bottle, and said formulation is a feeding formulation.

5. A method according to any one of Claims 1-4, wherein the container provided in step (a) has been sterilized before hand and wherein steps (a) and (b) are performed under aseptic conditions.

6. A method for providing an individual with a liquid formula containing recommended ingredients at appropriate concentrations, comprising: (a) providing a container having a dispensing opening, in at least two compartments, each for storing one component of the liquid formulation, at least one of which components being a liquid, the compartments being sealed one from the other by a seal, the integrity of which can be controllably impaired to allow mixing of the components, the dispensing opening being in flow communication with at least one of these components; (b) filling each of the compartments with one component of the liquid formulation in an amount such that when all components are mixed together, a liquid formulation will be formed with a concentration of the needed ingredients to meet required concentration; (c) providing the filled container obtained in step (b) to the individual; (d) opening the seal between the compartments and mixing all components to obtain a liquid formulation; and (e) administering the individual with said liquid formulation through the dispensing opening.

7. A method according to Claim 6, wherein said individual is a bottle-fed baby, infant or neonate, said container is a compartmentalized baby's feeding bottle, and said formulation is a feeding formulation.

8. A method according to Claim 6 or 7, wherein the liquid is sterile water.

9. A method according to any one of Claims 6-8, wherein the container provided in step (a) has been sterilized before hand and wherein steps (a) and (b) are performed under aseptic conditions.

10. A container with at least two compartments sealed from one another, which seal may be controllably opened, each of the compartments holding one component of at least two components of a liquid formulation which is reconstituted by mixing the at least two components, the amount of each component being such so as to yield after mixing a correct formulation to meet needs of the individual.

11. A container according to Claim 10, wherein each compartment is essentially sterile.

12. A container according to Claim 10 or 11 , wherein the container is a compartmentalized baby's feeding bottle, said formulation is a liquid nutrition formula and one of said at least two components is sterile water.