Single-use mixing reservoir for douche

Abstract: The device (1) for once-only use comprises a container (2), to the delivery mouth (4) of which a cannula (3) can be fitted. The container (2) comprises a body (6) and a sealed chamber (5) which are separated by stopper means (15, 20) neutralizable by bending or compressing the deformable portion (11) of the body (6) relative to the sealed chamber (5).

Description: This invention relates to a disposable device, preferably for application to hygiene. In the field of the aforementioned devices and in particular those used for administering vaginal washes or enemas, disposable devices are known comprising a deformable container, to the mouth of which a cannula can be sealedly fixed for insertion into the patient's body. Known disposable devices are sold with the container already filled with the solution ready for use and with their mouth sealed by a stopper which is removable preferably manually. For hygienic reasons the cannula is packaged separately in a sealed packet, but sold together with the container. The user (after necessarily shaking the container to revive the solution) removes the stopper from the mouth, withdraws the cannula from its package and fits it to the container mouth to obtain a device ready for use. The container of such devices is of plastics material as it has necessarily to be impermeable, soft and flexible. Experience has however shown that plastics material is not the best material for preserving certain substances which, being ready for use, are particularly active and hence aggressive and/or instable, and consequently of limited life. To overcome this drawback, devices have been considered comprising two containers of different capacity plus the already known cannula. One container is filled with some of the components of the solution and the other is filled with the remaining components. The division is obviously made so as to reduce the chemical activity of the components to a minimum, so achieving low aggressivity, substantial chemical stability and a long life. One of these devices is known through EP-A-03 5758. Such devices can therefore be constructed of plastics material at low cost. Forming the device as two containers can also be dictated by other requirements known to the expert but not mentioned herein for brevity. To form the solution ready for use the user has to pour the contents of the smaller container into the larger container in addition to carrying out all the operations already mentioned in relation to the preceding case, ie removing the stopper from two containers and fitting the cannula. There is also an obvious danger in pouring substances which usually have a high capacity for impregnation and hence a high staining power. In addition, this type of device does not allow optimum mixing of the contents of the two containers if said contents are poorly miscible with each other. In such a case the solution ready for use can only be achieved in an open container closable by the user's fingers during shaking, with the possibility both of contaminating the product and producing accidental splashing. Hence in the current state of the art the devices in use may comprise one or two containers. The choice is obviously dictated by the type of solution to be sold. The object of the present invention is to provide a device by which the aforesaid drawbacks are obviated, ie a disposable device preferably for application to hygiene, which allows relatively long-term preservation of tendentially unstable solutions aggressive towards the materials of construction of the device (preferably plastics material), even if said solutions comprise components which are difficult to mix and which hence generally require strong shaking of the solution before use, but without the user having to resort to uncomfortable pouring. This object is attained by a device in accordance with claim 1. By compressing the sealed chamber and bending it relative to the container body, the stopper means are neutralized by virtue of their at least partial removal, to hence connect the container body to the sealed chamber, allowing consequent mixing of the two products without the container mouth having to be unsealed. The neutralization of the stopper means can be achieved either by breaking it along a preferential line on the stopper or by removing the stopper from its seat. As the device itself is still sealed, the solution can be energetically shaken before use with total safety. In addition, by correctly dividing the components of the solution to be obtained by mixing, the chemical activity of the components can be reduced to a minimum, to the benefit of the preservability and integrity of the device materials. The invention is illustrated by way of non-limiting example in the figures of the accompanying drawings. Figure 1 is a section through a device according to the invention of the type intended for example for vaginal washes; Figure 2 is a section through the device of Figure 1 ready for use; Figure 3 is a section through a further device according to the invention; Figure 4 is a section through the device of Figure 3 shown during the removal of the stopper means. With reference to the aforesaid figures, the device of the invention, indicated overall by 1, comprises a container 2 and a cannula 3. The container 2 comprises a delivery mouth 4, a sealed chamber 5 and a body 6. The delivery mouth 4 is sealed by a manually removable cap 7. For this, the cap 7 comprises an appendix 8 acting as a guarantee seal, which when bent separates from the remaining part 9 of the cap along a preferential fracture edge 10. The sealed chamber 5 is positioned between the delivery mouth 4 and the deformable body 6. The sealed chamber 5 comprises a mouth 12 connecting to the body 6 of the container 2 and sealed by neutralizable stopper means, which vary according to the type of device. In proximity to the connection mouth 12 the container body 6 comprises a deformable portion 11 preferably of bellows structure provided at its two ends with opposing pairs of ribs 13. The thickness and structure of the portion 11 are such that it is much more flexible than the surrounding structures, both when stressed in a direction parallel and when stressed in a direction perpendicular to the delivery axis 14. The neutralizable stopper means can be at least of two types which are at least partly removable. A first type of said neutralizable stopper means, visible in Figures 1 and 2, comprises a hollow body 15 formed from a portion of open trapezoidal section 16 continuously joined to a closed conical portion 17 along a preferential fracture line 18. After the deformable body 6 has been filled, the hollow body 15 is pressed into the connection mouth 12. More specifically, the open trapezoidal portion 16 is pressed into the mouth 12, as a result of which the closed conical portion 17 is slackly inserted into an annular restriction 19. Neutralization of this first type of stopper means is achieved by simply pressing the sealed chamber 5 and then bending it relative to the body 6 along the axis 14. However, the stopper means can also be neutralized by merely bending the sealed chamber 5 relative to the body 6 along the axis 14. In this case the closed conical portion 17 is preferably of greater length than shown in Figure 1. The annular restriction 19 thus presses against the side of the closed conical portion 17 while the connection mouth 12 locks the open trapezoidal portion 16. The hollow body 15 is hence bent and breaks along the preferential fracture line 18, the closed conical portion 17 then separating from the portion 16 of trapezoidal section, to fall into the body 6. Although remaining in position in the mouth 12 the open trapezoidal portion 16 is no longer closed, and connects the container 6 to the sealed chamber 5, to allow the two products to be mixed together. The second type of neutralizable stopper means, visible in Figures 3 and 4, comprises only a closed portion 20 of trapezoidal section. After the deformable body 6 has been filled, the closed trapezoidal portion 20 is pressed into the connection mouth 12 to form the seal. Neutralization of this second type of stopper means is achieved by simply pressing the sealed chamber 5 against the body 6 along the axis 14. As the portion of closed trapezoidal section 20 (or rather its base wall 21 perpendicular to the axis 14) is of greater diameter then the annular restriction 19, it presses frontally against the inner walls of the restriction 19 and is pushed out of the mouth 12. In this case the removal of the stopper means is total. The two described stopper means are interchangeable, so that on assembling the device 1 one type can replace the other and vice versa on the container 6. In both cases the stopper means are removed while the container is still hermetically sealed by the manually removable appendix 8. Hence the container can be energetically shaken without any danger of the solution escaping. Hence poorly miscible solution components can also be adequately mixed together. In addition, if the solution is particularly aggressive it can be preserved until use separated in one and the same container into components of reduced chemical aggressivity and consequently for a long period without any solution alteration and/or container perforation occurring. After shaking, the user presses on the appendix 8 so that it bends relative to the axis 14, and is removed to leave a free opening. One end of the cannula 3 can then be pushed in at the preferential fracture edge 10 which forms, to hence make the device ready for use. The cannula 3 can be replaced by any other type of delivery member if required. The device 1 can also be used in sectors other than the hygiene sector, and generally in all those sectors in which unstable and/or particularly corrosive solutions are sold ready for use, even if the individual components of said solutions are miscible only by energetic shaking. In addition the compactness of the device (which comprises only one container) allows better use of the available space on packaging.

Claims: A disposable device (1) for application to hygiene and in particular for vaginal washes and/or enemas, comprising a container (2) provided with an at least partly deformable body (6) and a delivery mouth (4) to which the first end of a delivery member (3) can be sealedly fitted, its second end being insertable into the patient's body, characterised in that between said delivery mouth (4) and said container body (6) there is a sealed chamber (5) provided with a mouth (12) providing connection to the body (6) of the container (2) and closed by stopper means (15, 20) neutralizable by their at least partial removal as a result of interference between the walls of said stopper means (15, 20) and the walls of said body (6) of the container (2). A device as claimed in claim 1, characterised in that the stopper means comprise a hollow body (15) formed from a portion (16) of open trapezoidal section connected to a closed conical portion (17) along a preferential fracture line(18). A device as claimed in claim 1, characterised in that the stopper means comprise a portion (20) of closed trapezoidal section. A device as claimed in claim 1, characterised in that the container (2) comprises a deformable portion (11) adjacent to the sealed chamber (5). A device as claimed in claim 4, characterised in that the deformable portion (11) is a bellows. A device as claimed in claim 5, characterised in that said bellows is provided at its ends with pairs of ribs (13).

Inventors: LANFRANCONI ANTONIO, MUNARI GIORGIO, LANFRANCONI, ANTONIO, MUNARI, GIORGIO
Applicants: INGE SPA, INGE S.P.A.
Application year: 1992
Main classification: A61M3
IPC codes: B65D25, A61J1, A61M3