METHOD FOR MANUFACTURING A DEVICE FOR TEMPORARILY CONNECTING TWO CONTAINERS

Description

[0001] This patent application claims priority from the French patent application filed on October 19, 2018 under number FR1871237. Domaine de l'invention

[0002] The invention relates to a method for obtaining a container connection device for the temporary assembly of said containers, generally a vial for containing a substance and a bottle for containing a fluid, for the purpose of mixing said substance, such as a powder, a lyophilized product or a liquid, and said fluid such as a solvent.

[0003] In the present invention, the connection system comprises a closure sleeve, the first part of which is provided with a fastening system to ensure a tight seal with the bottle opening, and the second part of which is adapted to allow temporary fixation of the bottle opening. To prevent the contents of the bottle from inadvertently leaking from the bottle and being exposed to ambient air or water, the closure sleeve includes a membrane separating the first and second parts of the sleeve. The connection system is adapted to allow the membrane separating the first and second parts of the closure sleeve to be perforated as soon as the bottle is attached to the second part of the closure sleeve.When the bottle and the vial are fixed inside the closure sleeve, the fluid contained in said bottle can flow out by repeated pressure on the bottle or any flexible element of the bottle, such as a flexible bottom, and enter the inside of said vial, thus allowing the mixing of the substance and said fluid.

[0004] After mixing the substance and the fluid, the mixture can be transferred into the bottle and used at a place and time preferred by the user. Etat de la technique

[0005] Systems for packaging a substance and a fluid in two separate containers for the purpose of mixing said substance and fluid at a time chosen by the user are already known in the prior art. One such system is disclosed, for example, in EP 1009356 and is suitable for temporarily connecting a rigid container, such as a glass bottle, to a flexible container, such as a plastic bottle. FR 2 427 960 A1 also discloses a container connection system. According to EP 1009356, the container is particularly suitable for protecting the substance it contains from the influence of various external elements, such as water or oxygen, and thus preserving the properties of the substance within the container.The device as shown in document EP 1009356 may contain a product such as a cosmetic and / or a pharmaceutical product intended for skin treatment. The substance used for such treatment typically has active ingredients with beneficial effects on the skin. These active ingredients, protected by the bottle, are not degraded during filling, any freeze-drying process, or storage in the bottle. The user may, just before use, mix the substance and the fluid using the system disclosed in document EP 1009356 to obtain a mixture for use in skin treatment.

[0006] It should be noted that the connection system as disclosed in document EP 1009356 comprises a closure sleeve with a second part for temporarily securing the opening of a bottle essentially cylindrical in shape. Inside this cylinder, the second part of the closure sleeve has a thread for temporarily securing the bottle using this thread. Before use, this second part of the closure sleeve is open and includes an inner wall exposed to ambient air. This inner wall, being non-sterile, is therefore not protected against potential contamination.

[0007] In the event that the container connection system according to document EP 1009356 is used to mix a substance and a fluid, as described above, it is possible that a contamination potentially present on the inner wall of the closure sleeve may spread inside the bottle during the transfer steps of said fluid.

[0008] For the reason mentioned in the paragraph above, the container connection system as disclosed in document EP 1009356 is not suitable for mixing pharmaceutical products that must remain sterile before use.

[0009] In view of the above observations, it appears that there is a need to improve existing container connection systems designed to allow the mixing of a substance and a fluid.

[0010] One of the objectives of the present invention is to provide an improved container connection system compared to the system known in the prior art.

[0011] Another objective of the present invention is to provide a container connection system comprising inner walls which remain sterile prior to the use of said container connection system.

[0012] Another objective of the present invention is to provide a container connection system in which the presence of sterile inner walls generates the least possible additional cost in the production of such an improved container connection system. Objet de l'invention

[0013] The present invention relates to a method for obtaining a container connection system for the temporary assembly of a first and a second container, said connection system comprising a closure sleeve having a lower part adapted to be fixed onto the first container and having an upper part adapted to allow the fixing of the opening of the second container and having an integrated membrane, said membrane separating the upper part from the lower part of the closure sleeve, said membrane being adapted to be perforated by the second container when the latter is fixed onto the upper part of said closure sleeve, said connection system also comprising a cap for sealing the upper part of the closure sleeve before use of the connection system, in which said method comprises the following steps: close the closure sleeve and the cap using a simultaneous injection molding process of at least one plastic material, fix the cap on the upper part of the connecting device so as to seal said upper part of the closure sleeve, as soon as the cap and said closure sleeve come out of their respective molds.

[0014] According to one embodiment of the invention, the cap is fixed to the upper part of the closure sleeve before the cap and closure sleeve have been cooled to room temperature. Brève description des dessins

[0015] The purpose, object, and characteristics of the present invention will become clearer upon reading the following description, made with reference to the figures in which: there [ figure 1 ] shows a container connection system, according to a first embodiment, comprising a bottle, a sealing element, a closing sleeve and a stopper when assembled, the [ figure 2 ] represents a bottle, a still and a stopper when assembled, the [ figure 3 ] shows the bottle and the closure sleeve according to the figure 1 , and a bottle when fixing said bottle in said closure sleeve, the [ figure 4 ] represents the bottle, the closure sleeve and the cap according to the figure 3 , after their assembly, the [ figure 5 ] represents the assembly according to the figure 4 with the cap removed, the [ figure 6 ] shows a partial cross-sectional view of a closure sleeve and a cap fixed to the second part of said closure sleeve, the [ figure 7 ] represents a schematic view of a plurality of closure sleeves ready for removal from their mold and a plurality of caps, the [ figure 8 ] shows a schematic view of the positioning of a plurality of plugs aligned with, respectively, a plurality of closure sleeves before the exit of said closure sleeves from their respective molds, and the [ figure 9 ] represents a second embodiment of a bottle and a closure sleeve.

[0016] There figure 1 This shows a bottle 10 specifically adapted for packaging a substance such as a powder, a lyophilized powder, or a liquid. The bottle 10 is made of a material suitable for protecting the substance it contains from the influence of external elements, such as, among others, oxygen (O₂) and water (H₂O). Glass is a material perfectly suited for this purpose. The bottle 10 includes a base 11 at its lower end and an opening 14 at its upper end 12. This opening is adapted to allow the contents of the bottle 10 to be dispensed. Near its upper end 12, the bottle 10 is provided with fastening means 13, in the form of, for example, circular protrusions, forming a surface onto which the closure sleeve 30 can be fixed.

[0017] There figure 1 represents a sealing element 15 adapted to be inserted inside the bottle 10 to allow a leak-proof connection between said bottle 10 and the closure sleeve 30. The sealing element 15 can be made, for example, of a flexible material such as rubber or thermoplastic elastomer. The closure sleeve 30, as shown in the figure 1 , is provided with a first part 31 adapted to be fixed onto the bottle 10. It is not necessary to remove the closure sleeve 30 from the bottle 10 when using said bottle 10.

[0018] The closure sleeve 30 includes a second part 32 specifically adapted for the temporary fixing of a bottle (as shown in the figure 2 ).

[0019] The inner wall 33 of the second part 32 is provided with fixing means (not shown on the figure 1 ) allowing said temporary fixing of said bottle. The fixing means present on the inner wall 33 of the second part 32 of the closing sleeve 30 are, for example, in the form of a thread.

[0020] The second part 32 of the closure sleeve 30 can be sealed, before the use of the bottle 10 and said closure sleeve 30, with a stopper 40.

[0021] There figure 2 represents a bottle 20 particularly suitable for use in combination with bottle 10 and closure sleeve 30, as shown on the figure 1 Bottle 20 is suitable for packaging a fluid that can be mixed with the substance packaged in bottle 10. Said fluid, packaged in bottle 20, can be, for example, a solvent suitable for dissolving, at least partially, the substance contained in bottle 10 and / or forming with said substance an emulsion or suspension after mixing said substance contained in bottle 10 and the fluid contained in bottle 20.

[0022] The bottle 20 has a lower end 21 forming the bottom of said bottle 20 and an upper end 22 provided with an opening adapted to allow the contents of said bottle 20 to flow outwards. A dispenser 24 can be positioned on the opening located at the upper end 22 of the bottle 20. Said dispenser 24 can be used to expel a precise dose of the contents of the bottle 20 outwards. At its upper end 22, the bottle 20 is provided with fastening means 23, such as a thread, allowing the temporary fastening of said bottle 20 inside the second part 32 of the closure sleeve 30, as shown in the figure. figure 1 . Said fastening means 23 can also be used to fix a cap 25, said cap allowing the contents of the bottle 20 to be protected before use.

[0023] Bottle 20 is typically made of a flexible plastic material. The flexibility of the outer wall of bottle 20 allows the user to apply pressure with their finger to the outside of the bottle 20 in order to deform it. This deformation of bottle 20 allows its contents to be dispensed using the dispenser 24.

[0024] There figure 3 The figure shows the attachment of the bottle 20 inside the second part 32 of the closure sleeve 30. To allow this attachment, the cap 25 was first removed. When the bottle 20 is inserted into the second part 32 of the closure sleeve 30, said bottle can be moved towards a membrane 35. The function of said membrane 35 is to separate the interior of the first part 31 of the closure sleeve 30 from the interior of the second part 32 of said closure sleeve 30. The presence of said membrane 35 protects the substance 50 present inside the bottle 10 before the use of said bottle 10 and said closure sleeve 30. In a preferred embodiment, the membrane 35 is an integral part of the closure sleeve 30, the membrane being made of the same material as the first part 31 and the second part 32 of said closure sleeve 30.The membrane 35 forms a frangible zone adapted to be perforated by the dispenser 24 of the bottle 20 when said bottle 20 is introduced into the second part 32 of the closure sleeve 30. When the membrane 35 is perforated, the dispenser 24 can continue to advance until it is received inside an opening 16 present in the sealing element 15. Said sealing element 15 is located between the upper part of the bottle 10 and the inside of the first part 31 of the closure sleeve 30.

[0025] The distributor 24 is preferably made of a relatively rigid material. The rigidity of the distributor 24 allows it to pierce the membrane 35 without the membrane itself being deformed. Furthermore, the presence of the relatively rigid distributor 24 and a relatively flexible sealing element 15, which has an opening 16 for receiving the distributor 24, ensures a seal between the outside of the distributor 24 and the inside of the opening 16 after the bottle 20 has been fully inserted into the second part 32 of the closing sleeve 30.

[0026] After the bottle 20 is fully inserted into the closure sleeve 30, the fluid contained within said bottle 20 can flow, deforming the bottle 20 to increase the pressure inside said bottle 20, into the bottle 10. When the fluid is thus transferred from the bottle 20 into the bottle 10, it is possible to shake the entire assembly of the bottle 10, the closure sleeve 30, and the bottle 20 to obtain a mixture between the substance 50, present inside the bottle 10, and the fluid (not shown in the figure). figure 3 After mixing the fluid and substance 50, the entire assembly of the bottle 10, the closure sleeve 30, and the bottle 20 can be positioned vertically so that the bottle is above the bottle 20. By drawing the mixture of substance 50 and the fluid from the bottle 10 to the bottle 20, a deformation of the bottle 20 can be used to draw the mixture into the bottle. Once the mixture is drawn into the bottle 20, it can be used to dispense the mixture in a controlled manner, firstly by deforming the outer wall of the bottle 20 and secondly by using the dispenser 24. When the user no longer wishes to dispense the mixture, the bottle 20 can be sealed with the cap 25 (as shown in the figure). figure 2 ).

[0027] The entire assembly of the bottle 10, the closure sleeve 30, and the bottle 20, according to the invention, is particularly suitable for mixing a fluid and a substance 50, thanks to a closure sleeve 30 having a sterile interior. The sterile interior prevents potential contamination of the mixture of said fluid and said substance 50. To ensure a sterile interior, the second part 32 of the closure sleeve 30 is, before use, sealed with a stopper 40. The sealing of the closure sleeve 30 with a stopper 40 is shown in the figure. figure 4 .

[0028] There figure 4 represents the closure sleeve 30 fixed to the upper part of the bottle 10. The second part 32 of said closure sleeve 30 is wrapped and sealed with a cap 40. To remove the cap 40, it is provided with a tear-off tab 41. A frangible area, present between said tear-off tab 41 and the body of the cap 40, facilitates the removal of the tear-off tab 41. When the tear-off tab 41 is removed, the removal of the cap 40 from the closure sleeve 30 is facilitated.

[0029] There figure 5 shows the entire bottle 10 and the closure sleeve 30 after the cap 40 has been removed. According to the position as shown on the figure 5 The entire bottle 10 and the closure sleeve 30 are ready to receive the bottle 20, as shown in the figure 3 , inside the second part 32 of the closing sleeve 30.

[0030] There figure 6 represents a partial cross-sectional view of the entire closure sleeve 30 and cap 40 after their assembly. On the figure 6 The presence of membrane 35 can be seen; said membrane 35 is adapted to seal the inside of the first part 31 relative to the inside of the second part 32 of the closure sleeve 30. The stopper 40 is present to protect the inner wall 33 from any form of potential contamination before the use of the closure sleeve 30. In order to guarantee a sterile interior to the first part 31 of said closure sleeve 30, before its use, the interior of said first part 31 is sterilized before and / or during the attachment of the closure sleeve 30 to the bottle 10. The permanent attachment of the first part 31 to the bottle 10 (as shown in the figures) figures 3 à 5 ) guarantees that the inside of the first part 31 of the closing sleeve 30 is not contaminated before use.

[0031] According to the invention, the interior of the second part 32 of the closure sleeve 30 (as shown in the figure 6 ) is kept sterile in a particular way.

[0032] There figure 7 The diagram schematically shows a plurality of closure sleeves 30 and a plurality of caps 40. According to the present invention, said closure sleeves 30 and said caps 40 are obtained by means of a simultaneous injection molding process. In other words, said closure sleeves 30 and said caps 40 are directly assembled as soon as they are extracted from their respective molds, guaranteeing perfect sterility of the interior of the second part 32 of the closure sleeves 30 as well as of the interior of the caps 40.

[0033] There figure 8 represents a schematic view of an assembly as described in the paragraph above. A first mold, adapted for the production of a plurality of closure sleeves 30, is positioned near a second mold, adapted for the production of a plurality of caps 40. According to the example shown on the figure 8 The caps 40 are extracted from their respective molds, and each cap is positioned at the point from which the closure sleeves 30 are extracted from their respective molds. When the caps 40 are positioned at the ends of the closure sleeves 30, as shown in the figure 8 , said closure sleeves 30 are advanced, and extracted from their respective molds, in order to be automatically introduced, with their respective second part 32, inside each of the caps 40. When the assembly of the closure sleeves 30 and the respective caps 40 is carried out, the whole of said closure sleeves 30 and said caps 40 is removed from the exit of the area intended for the production of the closure sleeves 30, thus allowing the exit of the following products.

[0034] The closure sleeves 30 and the caps 40 are typically made of a plastic material such as HDPE or PP. A product made from the aforementioned materials has a temperature of approximately 50°C to 70°C as it exits the mold. Given the material processing temperature exceeding 200°C and the high temperature at the exit of the mold, it is established that the wall 33 of each of the second parts 32 of each of the closure sleeves 30 remains sterile. This means that the positioning of the cap 40 on the second part 32 of the closure sleeve 30 ensures the sealing of the inner wall 33 of each of said second parts 32 of each of the closure sleeves 30.

[0035] There figure 9 shows a second embodiment of a bottle 110 according to the invention, said bottle 110 being provided with a base 111 and an upper end 112. Said bottle 110, open at its upper end 112, is provided with an opening 114 adapted to allow the flow of the contents of said bottle 110. Fastening means 113 are present on the outside of the bottle 110, near the upper end 112. According to the embodiment shown in the figure 9 , said fixing means 113 are in the form of a thread, said thread being used to fix the closing sleeve 130 onto the bottle 110. The closing sleeve 130 is therefore screwed onto the thread 113 using its first part 131.

[0036] A 115 jointing element is also shown on the figure 9 The sealing element 115 is adapted to be inserted between the bottle 110 and the first part 131 of the closure sleeve 130. The sealing element 115 is made of a relatively flexible material compared to the material used to make the bottle 110 and the closure sleeve 130. As a result, from the moment of its assembly, the sealing element 115 ensures a seal between the bottle 110 and the closure sleeve 130.

[0037] The bottle 110 is made of a suitable material that protects the substance contained within it before use. This bottle 110 may, for example, be made of a material such as glass. The closure sleeve 130 is made of a plastic material such as HDPE or PP. The closure sleeve 130 is provided internally with a membrane that separates its first part 131 from its second part 132. This membrane is not shown in the diagram. figure 9 However, its shape and functionality are similar to those of membrane 35 as shown on the figure 3 .

[0038] Furthermore, in addition to the membrane integrated within the closing sleeve 130, it is possible to integrate a second membrane 136 between said closing sleeve 130 and the sealing element 115. Said membrane 136 can be made of a material such as aluminum and can be pre-fixed to the upper face (according to the orientation as shown in the figure 9 ) of the joining element 115. Such a membrane 136 has not been shown in combination with the first embodiment as shown in the figures 1 à 6 It should be noted that such a membrane can be positioned on the jointing element 15 as shown in the figures 1 And 3The exterior of the second part 132 of the closure sleeve 130 is provided with a thread 138. This thread 138 is used to secure a cap 140 to the exterior. Once the cap 140 is secured to the thread 138 on the exterior of the second part 132 of the closure sleeve 130, a tamper-evident ring 141 is automatically fixed, due to its plastic deformation, behind the edge 139 at the end of the closure sleeve 130. A frangible zone 142 is present between the cap 140 and the tamper-evident ring 141, this frangible zone 142 being designed to be broken when the cap 140 is first opened using the thread 138.

[0039] According to the present invention, the closure sleeve 130 and the cap 140 are obtained through a simultaneous injection molding process. This means that the closure sleeve 130 and the cap 140 are directly assembled as soon as they are removed from their respective molds, thus ensuring perfect sterility of the interior of the second part 132 of the closure sleeve 130 and the interior of the cap 140. The production and assembly of the closure sleeve 130 and the cap 140 are similar to those of the closure sleeve 30 and the cap 40, as described with reference to the paragraphs above concerning the figures 7 et 8 .

[0040] There figure 9 shows the joining element 115 provided with an opening 117, said opening 117 being used in a freeze-drying process.

[0041] The filling process for bottle 110 according to the present invention is as follows. Bottle 110 is pre-sterilized using a suitable process, for example, gamma rays or ethylene oxide. After said pre-sterilization, bottle 110 travels along an aseptic production line and is filled with a sterile solution comprising at least one active ingredient and water, which is then subjected to freeze-drying conditions. At the end of this step, the sealing element 115, provided on its upper surface with a membrane 136, enters the opening 114 of the bottle 110. First, the sealing element 115 is introduced in order to keep at least part of the opening 117 outside the bottle 110. After this step, the assembly consisting of the bottle 110 and the sealing element 115 is introduced into a chamber provided for the lyophilization step.At the end of said lyophilization process, the sealing element 115 is pushed completely inside the opening 114 of the bottle 110. Then, the assembly consisting of the closing sleeve 130 and the stopper 140 is fixed on the bottle 110 using, on the one hand, the thread 113 and, on the other hand, a complementary thread located inside the first part 131 of the closing sleeve 130.

[0042] Thanks to the co-manufacturing of the closing sleeve 30, in combination with the cap 40, or the closing sleeve 130 and the cap 140, the sterility of the respective inner wall 33, 133, of the respective closing sleeve 30, 130 and the inside of the respective cap 40, 140 is guaranteed.

Claims

1. A method for obtaining a container connection system intended for the temporary joining of a first and a second container, said connection system comprising a closing sleeve (30, 130) provided with a lower part (31, 131) suitable to be fixed onto the first container (10, 110), provided with an upper portion (32, 132) suitable for allowing the fixing of the opening of the second container (20) and provided with an integrated membrane (35), said membrane (35) separating the upper part (32, 132) from the lower part (31, 131) of the closing sleeve (30, 130), said membrane (35) being suitable to be perforated by the second container (20) when this is fixed onto the upper part (32, 132) of the closing sleeve (30, 130), said connection system also comprising a lid (40, 140) intended to close off the upper part (32, 132) of the closing sleeve (30, 130) before the use of the connection system, characterised in that said method comprises the following steps: - forming the closing sleeve (30, 130) and the lid (40, 140) using a simultaneous method of injection moulding at least one plastic material, - fixing the lid (40, 140) onto the upper part (32, 132) of the connection device in order to thus close off said upper part (32, 132) of the closing sleeve (30, 130), once the lid and the closing sleeve have exited their respective moulds.

2. The method according to Claim 1, wherein the lid (40, 140) is fixed onto the upper part (32, 132) of the closing sleeve (30, 130) before said lid (40, 140) and the closing sleeve (30, 130) are cooled to ambient temperature.