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Patent Searching and Data


Title:
ASEPTIC CONNECTION DEVICE
Document Type and Number:
WIPO Patent Application WO/1999/003528
Kind Code:
A1
Abstract:
A connection device comprises a first connecting means (2) and a second connecting means (3), which are interconnectible for the purpose of transferring an aseptic fluid. The first connecting means (2) comprises an injection needle (8) and a protecting sleeve (9) which has an orifice (10) that can be punctured and which at least partially surrounds the needle (8) and is displaceable relative thereto. The second connecting means (3) comprises a rubber-like part (15), which is penetratable by the needle (8) and resealable when the needle (8) is withdrawn.

Inventors:
SJOEHOLM JOHAN (SE)
Application Number:
PCT/SE1998/001373
Publication Date:
January 28, 1999
Filing Date:
July 13, 1998
Export Citation:
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Assignee:
AROM PAK AKTIEBOLAG (SE)
SJOEHOLM JOHAN (SE)
International Classes:
A61M5/162; A61M39/02; F16L29/00; B01L3/00; (IPC1-7): A61M39/18; A61M39/10
Foreign References:
EP0497229A11992-08-05
US3986508A1976-10-19
US5176673A1993-01-05
US5330448A1994-07-19
US5501676A1996-03-26
Attorney, Agent or Firm:
AWAPATENT AB (P.O. Box 5117 Malmö, SE)
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Claims:
CLAIMS
1. A connection device comprising a first connect ing means (2) and a second connecting means (3), which are interconnectible for the purpose of transferring an aseptic fluid, the first connecting means (2) comprising an injection needle (8) and a protecting sleeve (9) which has an orifice (10) that can be punctured and which at least partially sur rounds the needle (8) and is displaceable relative there to; and the second connecting means (3) comprising a rubberlike part (15), which is penetratable by the needle (8) and resealable when the needle (8) is withdrawn.
2. A connection device as claimed in claim 1, where in the first connecting means (2) has a first coupling member (6,7), and the second connecting means (3) has a second coupling member (11,13), said coupling members (6,7,11,13) being interconnectible, to hold the two connecting means (2,3) in the interconnected state when transferring an antiseptic fluid, and being disconnect ible from each other.
3. A connection device as claimed in claim 2, where in the coupling members (6,7,11,13) comprise thread joints (7,13) matching each other.
4. A connection device as claimed in any one of claims 13, wherein the second connecting means (3) is connected to a storage.
5. A connection device as claimed in claim 4, where in the rubberlike part (15) is arranged in engagement with a casing associated with the storage.
6. A connection device as claimed in claim 5, where in the storage is of the collapsing type.
7. A connection device between a) a storage (4) con taining an aseptic fluid (1) and comprising connecting means (2), b) means (3) for aseptic supply of said fluid (1) to a device (5), in which the fluid (1) under aseptic conditions is transferred between said storage and said device (5), c h a r a c t e r i s e d by a transferring device which is connectible to said storage (4) and com prises a holder I (6) which is provided with connecting threads (7), an injection needle (8) which is centrally located and connected in the holder I (6), and a protect ing sleeve (9) which is arranged in the transferring device and which surrounds the injection needle (8) and is movable into the holder I (6) in the direction of the injection needle (8) along a fitting against the inside of the holder 1 (6) and provided with an opening connec tion (10) which can be punctured, in that the means for supplying an aseptic fluid (1) comprises a device (11) consisting of a holder II (12) which is provided with threads (13) adapted to receive the threads of the holder I (6), and that the means (3) has at its bottom a rubber like part (15) which can easily be penetrated by the injection needle (8) and which, when the needle (8) is being withdrawn in connection with the termination of the connection, again forms an aseptic seal.
8. A connection device as claimed in claim 7, c h a r a c t e r i s e d in that the means (3) has an opening corresponding to the tapering front part of the protecting sleeve (9).
9. A connection device as claimed in claim 7, c h a r a c t e r i s e d in that the means (3) comprises an insert for said rubberlike part (5).
10. A connection device as claimed in claim 7, c h a r a c t e r i s e d in that the injection needle (8) and the protecting sleeve (9) are replaced in case of a repeated process.
11. A connecting means comprising an injection needle (8), and a protecting sleeve (9) which has an orifice (10) that can be punctured and which at least partially sur rounds the needle (8) and is displaceable relative there to.
12. A connecting means as claimed in claim 11, wherein the protecting sleeve (9) constitutes the wall of a sterile chamber surrounding the needle.
13. A connecting means as claimed in claim 12, wherein the connecting means at its end facing away from the orifice (10) of the protecting sleeve is connected to a sterile conduit (25).
Description:
ASEPTIC CONNECTION DEVICE The present invention relates to a connection device comprising a first connecting means and a second connect- ing means, which are interconnectible for the purpose of transferring an aseptic fluid. The invention also con- cerns a connecting means for such a device, and an asep- tic connection device between a) an aseptic fluid storage comprising connecting means and b) means for aseptic sup- ply of said fluid to a device.

It happens that small amounts of a fluid which has been prepared in a certain manner, for instance, steril- ised, are to be supplied under sterile conditions to a reaction vessel or a process conduit to be caused to con- tact therein other fluids or gases.

The handling of such preferably aseptic fluids can be effected if the fluid is sterilised in a vessel the inner sterility of which is controlled. By means of the suggested device, sterilisation occurs in a specific place, the fluid being enclosed in bags or plastic con- tainers to be subsequently transported to the place where the fluid is to be used. The invention thus concerns a connection device, by means of which it is possible to conveniently interconnect a storage of a fluid, which has been prepared in advance, with the space to which it is to be transported, in fact without affecting the sterility of the fluid.

The invention will now be described in terms of transferring an aseptic fluid to a reaction area, but the invention can be used in several other ways. For instance, it is possible to join a number of fluids with each other in a manner here described, and it is also possible to use, not only aseptic fluids, but also such fluids as spread odour, poison, bacteria and other non- desirable substances. Of course it is possible to use

the inventive connection device between different types of devices and for flows in optional directions.

The invention will now be described by means of three Figures, of which Fig. 1 illustrates the connec- tion device with two connecting parts which are spaced from each other. Moreover, Fig. 1 shows schematically how a treatment chamber is connected to a first connect- ing means and a storage is connected to a second connect- ing means.

Fig. 2 shows the two connecting means of the connec- tion device in the state intended for interconnection.

Fig. 3 shows the connection device in the intercon- nected state.

The description below follows the drawing which in the present case has been adjusted precisely to the fluids that are to be used.

In the case here described, the use intends to add, for instance, flavourings to a fluid, but the invention can just as well be used to affect another fluid for medicinal purposes.

Fig. 1 shows the device before the interconnecting operation. As is evident from the Figure, the connecting means 2 (male member) is connected to a treatment chamber 4 by means of a tube 25. The treatment chamber may be, for instance, a mixing chamber for adding a first fluid to a second fluid. In the cases where the fluid need be pumped out to yield a uniform flow, it is suitable to connect a pump between the treatment chamber 4 and the first connecting means 2. Here only the connecting func- tion will be described.

The first connecting means 2 comprises in the pre- sent case a body in the form of a moulded or turned plas- tic body 6, which has an essentially circular-cylindrical part 26 having an inner surface 21. Said circular-cylin- drical part 26 is integrated with a lower connecting part 27 with external threads 7. In the means 2, also a pro- tecting sleeve 9 is arranged, which consists of a plastic

sleeve intended to surround and protect an injection needle 8 which is inserted into the means 2 and which adjacent to a tube nozzle 20 is attached to the upper portion of the means 2. In the embodiment shown, the needle 8 is fixed to a plug supporting the tube nozzle.

The protecting sleeve 9 ensures that sterile surroundings are maintained around the needle 8. The protecting sleeve 9 is, along a sliding portion 18, fixed to the circular- cylindrical part 26 of the first connecting means 2 and is first prevented from moving along the slide path 21 by a narrow stop portion 19 which constitutes a narrowed part of the slide surface 21. The outer part of the pro- tecting sleeve 9 is provided with a thin front protective portion 10 at its opening and has a slightly conical front part.

The second connecting means (female member) 3, which is also shown in Fig. 1, is also made of a plastic mate- rial, preferably of the same type as the material of the means 2. The second connecting means 3 is fixed in a storage means 5 of the type that is to be used when effecting the operation, and may vary in many different ways. The second connecting means 3 according to Fig. 1 essentially consists of a holding part 22, an intercon- necting part 12, a receiving part 17 for the above-men- tioned protecting sleeve 9, and a portion having internal threads 13. The second connecting means 3 also comprises a rubber-like plug 15 which is arranged in an insert and is adapted to seal the lower part of the second connect- ing means 3, and the plug 15, which is exchangeable, is adapted to be fixed in a recess in the connecting means 3. The holding part 22 is primarily intended to connect the connecting means 3 with a joining means, such as the storage 5, and can, in other embodiments, be formed in some other suitable manner.

The threaded portions 7,13 of the two connecting means constitute first and second coupling means to keep the means 2,3 releasably coupled together. The coupling

means can also be designed in other alternative ways, for instance with a bayonet joint.

In Figs 2 and 3, the means 4,5 connected with the two connecting means of the connection device have been excluded. These Figures merely show how the two parts for aseptic transfer of fluid function.

Fig. 2 shows the connection device in the state where the threads 7 and 13 match each other, but where the protecting sleeve 9 has reached its bottom position by being clamped in the conical hole 17 with its front end wall 10 edge-to-edge with the rubber-like part 15.

In Fig. 2, the first connecting means 2 (male mem- ber) is screwed into the second connecting means (female member) a few turns, and the protecting sleeve 9 has reached its bottom position in the receiving part 17.

What happens if the threads are turned further is that the upper connecting means 2 is pressed further downwards whereas the protecting sleeve 9, which cannot advance further downwards, is pressed upwards past the stop por- tion 19 while the injection needle 8 cuts through the opening portion 10 of the protecting sleeve 9 and is pressed further through the rubber plug 15 which encloses the injection needle 8 in a tight fit.

Fig. 3 shows the end position of the device, in which the injection needle 8 is pressed through both the front part of the protecting sleeve 9 and through said rubber part 15 so as to then penetrate into the interior of the container 5 for receiving or discharging fluid 1.

The injection needle 8 now has a free space to transport aseptic fluid 1 from the storage 5 to the treatment cham- ber 4.

If the operation is to be terminated while there is still some aseptic material left in the storage container 5, the first connecting means 2 is unscrewed from the second connecting means 3 which retains its aseptic atmosphere by the rubber-like plug 15 aseptically seal- ing its duct path for the injection needle 8 when this

is being withdrawn. When a further fluid transfer from the storage 4 is to be initiated, it is possible to use a new first connecting means 2, which thus can be used as a disposable product. For maintaining sterility, the second connecting means 2 is sealed on its side facing away from the protecting sleeve 9, either immediately adjacent to the tube nozzle or, which is preferred, at the other end of a connected conduit 25.

The connection device according to the invention has been found extremely advantageous when transferring an aseptic fluid to or from a storage which has flexible walls and is of the collapsing type. The rubber-like part of the second connecting means is advantageously connect- ed directly to one of the flexible walls of the storage.

The connection device functions excellently when trans- ferring fluid in an optional direction and between two means of an optional kind. For instance, the invention is applicable in fluid transfer to a treatment chamber from a conduit connected to the first connecting means to a chamber connected to the second connecting means. The first connecting means further has great advantages also without cooperation with a second connecting means, for example when transferring fluid through a penetratable membrane.

By using the inventive method, it is possible to economise on sterile fluid in a satisfactory manner, and it is also possible to distribute the production of ste- rile fluid. Thus the sterile fluid need not at all be prepared by the user, but can be bought when required in bottles or plastic bags.