Device for temporarily connecting two containers
Patent Information
- Application Number
- IL280245
- Authority / Receiving Office
- IL · IL
- Patent Type
- Patents
- Current Assignee / Owner
- Priority Date
- 2018-10-19
- Filing Date
- 2019-10-18
- Publication Date
- 2026-08-01
- Estimated Expiration
- 2039-10-18
AI Technical Summary
Existing container connection systems are not suitable for mixing pharmaceutical products as they may introduce contamination due to non-sterile interior walls, which is a concern for maintaining sterility before use.
A container connection system featuring a closing sleeve with a membrane that separates the first and second parts, where the membrane is perforated during assembly to allow fluid transfer while maintaining sterility, and the cap is fixed to the second part before cooling, ensuring the system remains sterile and reducing additional production costs.
The system effectively prevents contamination by maintaining sterile interior walls during the mixing of substances and fluids, ensuring the integrity of pharmaceutical products until use.
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Abstract
Description
[0001] DESCRIPTION
[0002] TITLE: DEVICE FOR TEMPORARY CONNECTION OF TWO CONTAINERS
[0003] This patent application claims priority from the French patent application filed on October 19, 2018 under number FR1871237.
[0004] Scope of the invention
[0005] The invention relates to a container connection device intended for the temporary assembly of said containers, generally a vial to contain a substance and a bottle to contain 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.
[0006] According to 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 fixed onto the second part of the closure sleeve.When the bottle and the vial are fixed inside the closure sleeve, the fluid contained in said vial can flow out by repeated pressure on the vial or any flexible element of the vial, such as a flexible base, and enter the inside of said vial, thus allowing the mixing of the substance and said fluid.
[0007] After mixing the substance and the fluid, the mixture can be transferred into the bottle and used at a location and time preferred by the user. State of the art
[0008] Systems for packaging a substance and a fluid in two separate containers for the purpose of mixing said substance and fluid at a user-selected time 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. 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 EP 1009356 can contain a product such as a cosmetic and / or a pharmaceutical product intended for skin treatment.The substance used for such treatment typically contains 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 can, 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.
[0009] 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.
[0010] 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.
[0011] 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.
[0012] 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.
[0013] 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.
[0014] 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.
[0015] 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.
[0016] Object of the invention
[0017] The object of the present invention is a container connection system intended for the temporary assembly of a first and a second container, said connection system comprising a closure sleeve, having a first part adapted to be fixed onto the first container, and said closure sleeve also having a second part adapted to allow the temporary fixing of the opening of the second container, and a membrane separating said first and said second part of said closure sleeve, said membrane being adapted to be perforated by the second container when the latter is fixed onto the second part of the closure sleeve, in which said connection system includes a cap intended to seal the second part of the closure sleeve before use of the connection system,said cap and said closure sleeve being obtained by means of a simultaneous injection molding process of a plastic material, the cap being fixed to the second part of the closure sleeve as soon as the cap and closure sleeve exit their respective molds.
[0018] According to one embodiment of the invention, the cap is fixed to the second part of the closure sleeve before the cap and said closure sleeve have cooled to room temperature.
[0019] According to one embodiment of the invention, the membrane is an integral element of the closure sleeve and comprises a plastic material essentially similar, preferably similar, to the material used for the first part and the second part of said closure sleeve.
[0020] According to one embodiment of the invention, the cap is provided with a frangible area in the form of a tearable tab adapted to be removed and thus facilitating the removal of said cap from the second part of the closure sleeve.
[0021] A second aspect of 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, in which said method comprises the following steps:
[0022] to close the sealing sleeve and the cap using a simultaneous injection molding process of at least one plastic material,
[0023] fix the cap onto the second part of the connection device so as to seal said second part of the closing sleeve, as soon as the cap and said closing sleeve come out of their respective molds.
[0024] According to one embodiment of the invention, the cap is fixed to the second part of the closure sleeve before the cooling of said cap and said closure sleeve to room temperature.
[0025] Brief description of the drawings
[0026] The purpose, object and features of the present invention will become clearer upon reading the following description, made with reference to the figures in which: [Figure 1] shows a container connection system, according to a first embodiment, comprising a bottle, a sealing element, a closing sleeve and a stopper during their assembly,
[0027] - Figure 2 represents a bottle, a still and a stopper during their assembly.
[0028] - Figure 3 shows the bottle and the closure sleeve as shown in Figure 1, and a bottle during the fixing of said bottle in said closure sleeve,
[0029] - Figure 4 shows the bottle, the closure sleeve and the cap as shown in Figure 3, after their assembly.
[0030] - Figure 5 shows the assembly as shown in Figure 4 with the cap removed.
[0031] - Figure 6 shows a partial cross-sectional view of a closure sleeve and a cap fixed to the second part of said closure sleeve,
[0032] - Figure 7 represents a schematic view of a plurality of closure sleeves ready for removal from their mold and a plurality of caps,
[0033] - 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
[0034] - Figure 9 represents a second embodiment of a bottle and a closure sleeve according to the invention.
[0035] Figure 1 shows a bottle 10 specifically adapted for packaging a substance such as a powder, a lyophilized powder, or a liquid. This 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, for example, in the form of circular protrusions, forming a surface onto which the closure sleeve 30 can be fixed.
[0036] Figure 1 shows a sealing element 15 adapted to be inserted into the bottle 10 to provide a leak-proof connection between the 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 Figure 1, has a first portion 31 adapted to be attached to the bottle 10. It is not necessary to remove the closure sleeve 30 from the bottle 10 when using the bottle 10.
[0037] The closure sleeve 30 includes a second part 32 specifically adapted for the temporary attachment of a bottle (as shown in Figure 2). The inner wall 33 of the second part 32 is provided with fastening means (not shown in Figure 1) for said temporary attachment of the bottle. The fastening means on the inner wall 33 of the second part 32 of the closure sleeve 30 are, for example, in the form of a thread.
[0038] The second part 32 of the closure sleeve 30 can be sealed, before use of the bottle 10 and said closure sleeve 30, with a stopper 40. Figure 2 shows a bottle 20 particularly suitable for use in combination with the bottle 10 and the closure sleeve 30, as shown in Figure 1. The bottle 20 is suitable for packaging a fluid that can be mixed with the substance packaged in the bottle 10. Said fluid, packaged in the bottle 20, can be, for example, a solvent suitable for dissolving, at least partially, the substance contained in the bottle 10 and / or for forming an emulsion or suspension with said substance after mixing said substance contained in the bottle 10 and the fluid contained in the bottle 20.
[0039] 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 attachment of said bottle 20 inside the second part 32 of the closure sleeve 30, as shown in Figure 1. Said fastening means 23 can also be used to attach a cap 25, said cap serving to protect the contents of the bottle 20 before its use.
[0040] 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.
[0041] Figure 3 shows the bottle 20 being secured inside the second part 32 of the closure sleeve 30. To enable this securing, the cap 25 was first removed. When the bottle 20 is inserted into the second part 32 of the closure sleeve 30, the bottle can be moved towards a membrane 35. The function of the 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 the closure sleeve 30. The presence of the membrane 35 protects the substance 50 inside the bottle 10 before the bottle 10 and the closure sleeve 30 are used. In a preferred embodiment, the membrane 35 is an integral part of the closure sleeve 30, being made of the same material as the first part 31 and the second part 32 of the 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.
[0042] 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.
[0043] After the bottle 20 is fully inserted into the closure sleeve 30, the fluid contained inside said bottle 20 can flow out, deforming the bottle 20 to increase the pressure inside said bottle 20, towards the inside of the bottle 10. When the fluid is thus transferred from the bottle 20 into the inside of the bottle 10, it is possible to shake the whole of the bottle 10, the closure sleeve 30 and the bottle 20 in order to obtain a mixture between the substance 50, present inside the bottle 10, and the fluid (not shown in figure 3). After mixing said fluid and substance 50, the entire flask 10, closure sleeve 30 and bottle 20 can be arranged vertically so that the flask is above the bottle 20 and, by suction through a deformation of the bottle 20, allow the transfer of the mixture of substance 50 and fluid from flask 10 to bottle 20.Once the mixture is drawn into the bottle 20, it can be used to distribute said mixture in a controlled manner, on the one hand by means of the deformation of the outer wall of the bottle 20 and, on the other hand by using the dispenser 24. When the user no longer wishes to distribute the mixture, the bottle 20 can be closed with the cap 25 (as shown in Figure 2).
[0044] 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.
[0045] 40. The sealing of the closure sleeve 30 with a plug 40 is shown in Figure 4.
[0046] Figure 4 shows 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.
[0047] 41. When the tear-off tab 41 is removed, the removal of the cap 40 from the closure sleeve 30 is facilitated.
[0048] Figure 5 shows the entire bottle 10 and the closure sleeve 30 after the removal of the cap 40. According to the position as shown in Figure 5, the entire bottle 10 and said closure sleeve 30 is ready to receive the bottle 20, as shown in Figure 3, inside the second part 32 of the closure sleeve 30.
[0049] Figure 6 shows a partial cross-sectional view of the complete closure sleeve 30 and stopper 40 assembly. Figure 6 shows the presence of the membrane 35, which is adapted to seal the inside of the first part 31 from the inside of the second part 32 of the closure sleeve 30. The stopper 40 protects the inner wall 33 from potential contamination before the closure sleeve 30 is used. To ensure a sterile interior for the first part 31 of the closure sleeve 30, the interior of the 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 Figures 3 to 5) ensures that the interior of the first part 31 of the closure sleeve 30 is not contaminated before use.
[0050] According to the invention, the interior of the second part 32 of the closure sleeve 30 (as shown in Figure 6) is kept sterile in a particular way.
[0051] Figure 7 schematically illustrates 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.
[0052] Figure 8 shows a schematic view of an assembly as described in the preceding paragraph. A first mold, adapted for producing a plurality of closure sleeves 30, is positioned near a second mold, adapted for producing a plurality of caps 40. As shown in 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. When the caps 40 are positioned at the ends of the closure sleeves 30, as shown in Figure 8, the closure sleeves 30 are advanced and extracted from their respective molds so that they are automatically inserted, along with their respective second part 32, into each of the caps 40.When the assembly of the closing sleeves 30 and the respective plugs 40 is completed, the assembly of said closing sleeves 30 and said plugs 40 is removed from the exit of the area intended for the production of the closing sleeves 30, thus allowing the exit of the following products.
[0053] The closure sleeves 30 and the caps 40 are typically made from a plastic material such as HDPE or PP. A product obtained using the aforementioned materials has, as it comes out of the mold, a temperature of approximately 50 °C to 70 qC. Given the material processing temperature exceeding 200 °C and the high temperature upon removal from 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 plug 40 on the second part 32 of the closure sleeve 30 guarantees the sealing of the inner wall 33 of each of said second parts 32 of each of the closure sleeves 30.
[0054] 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 Figure 9, said fastening means 113 are in the form of a thread, said thread serving to fix the closure sleeve 130 onto the bottle 110. The closure sleeve 130 is therefore screwed onto the thread 113 by means of its first part 131.
[0055] A sealing element 115 is also shown in Figure 9, said sealing element 115 being 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, as soon as it is assembled, the sealing element 115 ensures a seal between the bottle 110 and the closure sleeve 130.
[0056] The bottle 110 is made of a suitable material that protects the substance contained within it before use. This bottle 110 can, 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 Figure 9. However, its shape and function are similar to those of the membrane 35 shown in Figure 3. Furthermore, in addition to the membrane integrated within the closure sleeve 130, a second membrane 136 can be integrated between the closure sleeve 130 and the sealing element 115.The membrane 136 can be made of a material such as aluminum and can be pre-fixed to the upper face (according to the orientation shown in Figure 9) of the sealing element 115. Such a membrane 136 has not been shown in combination with the first embodiment as shown in Figures 1 to 6. It should be noted that such a membrane can be positioned on the sealing element 15 as shown in Figures 1 and 3. The outside of the second part 132 of the closing sleeve 130 is provided with a thread 138. This thread 138 is used to fix a plug 140 to the outside. As soon as the cap 140 is fixed on the thread 138, outside the second part 132 of the closing sleeve 130, a tamper-evident ring 141 is automatically fixed, under the effect of its plastic deformation, behind the edge 139 at the end of said closing sleeve 130.A frangible zone 142 is present between the cap 140 and the tamper-evident ring 141, said frangible zone 142 being adapted to be breakable during the first opening of the cap 140 using the thread 138.
[0057] 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 extracted 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 Figures 7 and 8.
[0058] Figure 9 shows the joining element 1 15 provided with an opening 1 17, said opening 1 17 being used in a freeze-drying process.
[0059] The filling process for vial 110 according to the present invention is as follows. Vial 110 is pre-sterilized using a suitable process, for example, gamma rays or ethylene oxide. After said pre-sterilization, vial 110 is routed along an aseptic production line and 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 1 15, provided on its upper surface with a membrane 136, enters the opening 1 14 of the bottle 1 10. First, the sealing element 1 15 is introduced in order to keep at least part of the opening 1 17 outside the bottle 1 10. After this step, the assembly consisting of the bottle 1 10 and the sealing element 1 15 is introduced into a chamber provided for the lyophilization step.At the end of said lyophilization process, the sealing element 1 15 is pushed completely inside the opening 1 14 of the bottle 1 10. Then, the assembly consisting of the closing sleeve 130 and the stopper 140 is fixed on the bottle 1 10 using, on the one hand, the thread 1 13 and, on the other hand, a complementary thread located inside the first part 131 of the closing sleeve 130.
[0060] 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
DEMANDS 1. Container connection system for the temporary assembly of a first and a second container (10, 110), said connection system comprising a closure sleeve (30, 130) having a first part (31, 131) adapted to be fixed to the first container (10, 110), and said closure sleeve (30, 130) also having a second part (32, 132) adapted to allow the temporary fixing of the opening of the second container (20), and a membrane (35) separating said first (31, 131) and said second (32, 132) parts of said closure sleeve (30, 130), said membrane (35) being adapted to be perforated by the second container (20) when the latter is fixed to the second part (32, 132) of the closure sleeve (30, 130), characterized in that said The connection system includes a plug (40, 140) intended to seal the second part (32, 132) of the closing sleeve (30,130) before the use of the connection system, said cap (40, 140) and said closure sleeve (30, 130) being obtained by means of a simultaneous injection molding process of at least one plastic material, the cap (40, 140) being fixed to the second part (32, 132) of the closure sleeve (30, 130) as soon as the cap (40, 140) and the closure sleeve (30, 130) are exited from their respective molds.
2. Container connection system intended for the temporary assembly of said containers according to claim 1, the cap (40, 140) being fixed on the second part (32, 132) of the closure sleeve (30, 130) before the cap (40, 140) and the closure sleeve (30, 130) are cooled to ambient temperature.
3. Container connection system for the temporary assembly of said containers according to one of claims 1 or 2, wherein the membrane (35) is an integral element of the closure sleeve (30, 130) and comprises a plastic material substantially similar, preferably similar, to the material used for the first part (31, 131) and the second part (32, 132) of the closure sleeve (30, 130).
4. Container connection system intended for the temporary assembly of said containers according to any one of claims 1, 2 or 3, wherein the cap (40) is provided with a frangible area in the form of a tearable tab (41), adapted to be removed and thus facilitating the removal of said cap (40) from the second part (32) of the closure sleeve (30).
5. Container connection system for the temporary assembly of said containers according to any one of claims 1, 2 or 3, wherein the cap (140) is provided with a tamper-evident ring (141), adapted to be separated from the body of said cap (140) during the initial opening of said cap (140).
6. 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 to the first container, 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 to the upper part of the closure sleeve, characterized in that said method comprises the following steps: forming the closure sleeve and the cap using a simultaneous injection molding process of at least one plastic material,fix the cap onto the second part of the connection device to seal said second part of the closing sleeve, as soon as the cap and closing sleeve are removed from their respective molds.
7. A method according to claim 6, wherein the stopper is fixed to the second part of the closure sleeve before cooling said stopper and the closure sleeve to room temperature.