Device and method for contamination-free and/or sterile sealing between at least two interconnectable connecting means

A method and a device are provided for contamination-free and/or sterile sealing between two interconnectable connecting elements having opposing openings. Interconnection allows transfer of a fluid between the openings. Sealing elements are arranged on the connecting elements around the openings, and protective films are provided, covering the sealing elements and the openings and adapted to be removed in the final interconnection. The sealing elements are each provided with at least one recess which extends wholly or partly around the associated opening and receives a gas. In use the sealing elements are moved into engagement with each other, interleaved with the protective films, to reduce the volume of the recesses and, thus, increase the pressure of the gas therein. During removal of the protective films, the gas flows out of the recesses to the environment to prevent penetration of contamination into the openings.

FIELD OF THE INVENTION

The present invention relates generally to a sealing method and a sealing device preferably of the disposable type to be used in a variety of fields, for instance in the pharmaceutical, food and biotechnology fields, and also in other contexts such as handling of pharmaceutical preparations on patients, blood handling, handling of cytostatics, where the safety of the operator is important, handling of fluids in the semiconductor and aerospace industry etc.

More specifically, the invention relates to a method for contamination-free and/or sterile sealing between at least two interconnectable connecting means with opposing openings to allow, after interconnection, transfer of a fluid between them, sealing elements being arranged on the connecting means around the openings and provided with protective films covering the sealing elements and the openings and adapted to be removed in the final interconnection.

The invention also relates to a device for contamination-free and/or sterile sealing between at least two interconnectable connecting means with opposing openings to allow, after interconnection, transfer of a fluid between them, the device having sealing elements which are arranged on the connecting means around the openings and are provided with protective films which cover the sealing elements and the openings and are removable in the final interconnection.

BACKGROUND ART

In many fields, of which a few have been mentioned above as examples, it is normally necessary to transfer fluids from one process unit, such as a vessel or bag of a conventional type or of a now more common disposable type, to another or to other equipment without these fluids risking to be contaminated with foreign particles, especially airborne bacteria and the like or gaseous air pollutants. In the fields above, there is, inter alia, a more or less continuous need for sampling of fluids, for instance for microbiological control, cell counting or various chemical analyses, or supply of regulating or active substances, for instance a pH buffer or a biological starter culture, in certain process steps in the manufacture of products in the respective fields. Whenever a new connection for the purposes above has to be made to transfer fluids from one vessel to another, there is a great risk of contamination of the fluids, especially in non-sterile spaces.

Such connection can occur by introducing a sterile needle connected to one vessel via a tube or pipe, into a sterile membrane connected to the other vessel. In the interconnection, the connecting components and/or the fluids are exposed to the risk of being contaminated with airborne bacteria, spores etc. and by incorrect handling of the connecting components.

To reduce the risk of contamination when interconnecting two or more vessels for transfer of fluids between them, instead of the above-described needle connecting device, a sterile connector has been suggested, inter alia, by U.S. Pat. No. 3,909,910, with a device for sealing between two interconnectable connecting means included in the sterile connector, with opposing openings to allow, when interconnected, transfer of a fluid between them. The device has sealing elements, which are arranged on the connecting means around the openings and are provided with protective films covering the sealing elements and the openings and being removable in the final interconnection. With the connecting means arranged end-to-end with the openings opposite each other, and with the sealing elements pressed against each other during elastic deformation, the protective films engaging each other are manually pulled off at the same time from the connecting means.

When pulling off the protective films, they are folded back on themselves, and even if they are very thin there arises in the folding area a small gap with a width corresponding to the width of the protective films. This gap “moves” in the pull-off direction and passes the area of the openings in the sealing elements and the connecting means, so that airborne contamination is entrained by the gap and risks entering the openings and contaminating the fluid.

OBJECTS OF THE INVENTION

The main object of the present invention is to provide a method and a device of the type stated by way of introduction, which in a new and unique way effectively eliminate the above-described drawbacks and the risks of contamination of fluids when interconnecting two or more vessels or process units for fluid transfer between them.

Another object of the invention is to provide such a method and such a device, which result in a contamination-free and/or sterile sealing in such a manner that airborne bacteria, spores, microorganisms and other external contaminants cannot enter and mix with the fluids that are transferred between the connecting means.

A further object of the invention is to provide a method and a device where all conventional requirements are satisfied as to contamination-free transfer of the fluid all the way from one process unit/vessel to another and/or to supply of substances or sampling etc.

SUMMARY OF THE INVENTION

The above and other related objects of the invention are achieved in a simple as well as effective manner in the method according to the invention by at least one of the sealing elements being provided with at least one recess, which extends wholly or partly around the associated opening and receives a gas, the sealing elements being, when interconnecting the connecting means, moved into engagement with each other, interleaved with the protective films, to change the volume of the recess and, thus, change the pressure of the gas therein, and, in the subsequent quick removal of the protective films, the gas creating by its pressure a flow which prevents penetration of contamination into the openings in the final interconnection of the connecting means.

With respect to the device according to the invention, the above and other related objects are achieved in the same simple and effective manner by at least one of the sealing elements being provided with at least one recess, which extends wholly or partly around the associated opening and receives a gas, the sealing elements, when interconnecting the connecting means, being movable into engagement with each other, interleaved with the protective films, to change the volume of the recess and, thus, change the pressure of the gas therein, and, in the subsequent quick removal of the protective films, the gas creating by its pressure a flow which prevents penetration of contamination into the openings in the final interconnection of the connecting means.

In a preferred embodiment, the sealing elements are moved into engagement with each other to increase the volume of the recess or recesses and, thus, reduce the pressure of the gas therein, and, in the subsequent quick removal of the protective films, the gas sucks in additional gas to provide a flow which prevents penetration of contamination into the openings in the final interconnection of the connecting means.

In a still more preferred embodiment of the method, the sealing elements are moved into engagement with each other in order to instead reduce the volume of the recess or recesses and, thus, instead increase the pressure of the gas therein, and, in the subsequent quick removal of the protective films, the gas flows out of the recesses to prevent penetration of contamination into the openings in the final interconnection of the connecting means.

In a further development of the method, the sealing elements are preferably provided with at least two groups of recesses with different volumes, which cooperate in pairs and are positioned one outside the other and the sealing elements, when moved against each other, reduce the different volumes of the recesses and, thus, increase the pressure of the gas therein differently, so that the gas, in the removal of the protective films, flows from the group of recesses with the highest pressure to the group/groups of recesses with a lower pressure. Then the highest pressure is preferably generated in the innermost group of recesses and a successively decreasing pressure is generated in the group/groups of recesses outside these to force the gas in the direction of the environment.

It is then advantageous if the recesses in at least one group are divided into partial recesses to prevent all gas therein from flowing out before complete removal of the protective films.

Moreover, in a particularly preferred embodiment, there are arranged between the groups of recesses additional separate recesses with a limited extent to create, when starting to remove the protective films, an intensification of the gas flow in the direction of the environment.

It is particularly convenient to make preferably at least one of the sealing elements elastically yieldable so as to be expanded or compressed in the interconnection of the connecting means.

In the corresponding preferred embodiment of the device, the sealing elements are movable into engagement with each other to increase the volume of the recesses and, thus, reduce the pressure of the gas therein, and, in the subsequent quick removal of the protective films, the gas is caused to suck in additional gas and thus create a flow which prevents penetration of contamination into the openings in the final interconnection of the connecting means.

In the particularly preferred embodiment, the sealing means are movable into engagement with each other to reduce the volume of the recesses and, thus, increase the pressure of the gas therein, and, in the subsequent quick removal of the protective films, the gas is caused to flow out of the recesses and, thus, prevent penetration of contamination into the openings in the final interconnection of the connecting means.

The sealing elements are conveniently provided with at least two groups of recesses with different volumes, which cooperate in pairs and are positioned one outside the other. Then the sealing elements are caused, when being moved together, to reduce the different volumes of the recesses and, thus, increase the pressure of the gas therein differently. The gas is then, in the removal of the protective films, forced out of the group of recesses with the highest pressure to the group/groups of recesses with a lower pressure.

Then the highest pressure of the gas conveniently prevails in the innermost group of recesses and a successively decreasing pressure prevails in the group/groups of recesses outside these to force the gas in the direction of the environment.

Correspondingly, in the device according to the invention, the recesses in at least one group are suitably divided into partial recesses to prevent all gas therein from flowing out before complete removal of the protective films.

In a further development of the device according to the invention, additional separate recesses with a limited extent are suitably arranged between the groups of recesses to create, when starting to remove the protective films, an intensification of the gas flow in the direction of the environment.

In a preferred embodiment of the device, at least one of the sealing elements is preferably compressible in the interconnection of the connecting means, the compressible sealing element/sealing elements in one embodiment suitably having the form of inserts of an elastically yieldable material which are arranged in the associated connecting means.

In a particularly preferred further development of the device according to the invention, there is arranged, outside each sealing element, a substantially circumferential seal of an elastically yieldable material on the associated connecting means, on which seals the protective films are sealingly arranged at their outer edge and which seals, interleaved with the protective films, are movable into engagement with each other in the interconnection of the connecting means.

DESCRIPTION OF A PREFERRED EMBODIMENT

The accompanying drawings illustrate a sterile connector generally designated1, made of a suitable material such as plastic for presterilised connection, sealed against contamination, of two or more process units (not shown), such as receptacles/vessels of metal or rigid plastic or bags of non-rigid plastic of a conventional re-use type or of a disposable type, via tubes or pipes (not shown) preferably made of non-rigid plastic.

More specifically, the sterile connector1comprises as main components first and second connector halves2,3, also referred to as male and female parts. The connector halves2,3each have an elongate connecting means4and5, respectively, which at their outer free ends each have a nipple6to be connected to one end of the tubes (not shown). The other ends of the tubes are, in a manner not shown, connected to the associated process unit. As a variant, one of the connecting means4,5can at its free end be directly connected to its process unit.

Each connecting means4,5has an elongate through duct7which extends from the associated nipple6to an opening8towards the other ends of the connecting means4,5. The openings8open into substantially flat connecting planes9on one side of the connecting means and extend substantially in the longitudinal direction thereof. When interconnecting the two connecting means4,5in a manner that will be described below, the openings8face each other and are positioned opposite each other in order to allow, after the interconnection, contamination-free transfer of a fluid (not shown), such as a gas or liquid or a mixture thereof, between them and thus the process units.

A device, generally designated10, for contamination-free sealing between the two interconnectable connecting means4,5has sealing elements11,12which are each arranged on a connecting means around the associated opening8therein. The sealing elements11,12, which will be described in more detail below, are each provided with a protective film13of a very thin and yet very tight plastic. The protective films13cover the associated sealing element11,12and opening8and are adapted to be removed in conjunction with the final interconnection of the connecting means4,5.

In the preferred embodiment shown in the drawings, at least the sealing element12arranged on the connecting means5of the second connector half3, the female part, is compressible in the form of an insert14arranged in the connecting means and made of an elastically yieldable material such as plastic, rubber or the like, with elastic and sealing properties that are necessary for the purpose.

In the embodiment illustrated, a further, substantially circumferential seal15is arranged outside and around each sealing element11,12, which seal is also made of a suitable, elastically yieldable material such as plastic or rubber and is arranged on the associated connecting means4,5. The above-described protective films13are at their outer edge, that is along their periphery, in a sealing but tear-off manner, attached to the seals15, for instance by gluing, welding or the like. In a manner that will be described below, the seals15, interleaved with the protective films13, are movable into engagement with each other in the interconnection of the connecting means4,5.

Referring once more to the sealing elements11,12on the connecting means4,5, they are each provided with at least one recess16and17, respectively, which has the form of a groove or depression and extends wholly or partly around the associated opening8in the connecting means5,6. The recesses16,17receive or contain a gas18, for instance an inert gas or a sterile gas, such as sterile air.

In the particularly preferred embodiment illustrated in the drawings, the sealing elements11,12are provided with two groups of recesses16,17with different volumes, positioned one outside the other and cooperating in pairs. However, there is nothing to prevent that there is only one recess16,17or three or more recesses16,17positioned one outside the other around the associated opening8.

When interconnecting the connecting means4,5, the sealing elements11,12are in the same way as the seals15movable into engagement with each other, interleaved with the protective films13. When the connecting means4,5are pressed against each other, the volume or the different volumes of the recesses16,17is/are reduced, depending on the number of groups of recesses, thus increasing the pressure of the gas18therein evenly or differently for the same reasons.

When after that the protective films13are, in a manner described below, quickly removed or torn off simultaneously and jointly from the sealing elements11,12and the seals15, the pressure increase in the recesses16,17forces the gas18out of the recesses, thus preventing penetration of contamination into the openings8of the connecting means4,5in the final interconnection of these means.

In the preferred embodiment with two or more groups of recesses16,17arranged one outside the other and where the highest gas pressure prevails in the innermost group and a successively decreasing gas pressure prevails in the group or groups outside the same, the gas18is forced, when removing the protective films, out of the group with the highest pressure to the group or groups with a lower pressure outwards to the environment19.

To prevent not all the gas18in the recesses16,17from flowing out before complete removal of the protective films13, the recesses in at least one group, in the shown embodiment preferably both, can be divided into partial recesses16aand16bregarding the recesses16, and17aand17bregarding the recesses17.

To create, when starting to remove the protective films13, an intensification of the gas flow in the direction of the environment19, there are in the shown embodiment additional, separate recesses20with a limited extent in the longitudinal direction in the sealing elements11,12between the above-described groups of recesses16,17.

The function and handling of the above-described sterile connector1will now be briefly described step by step with special reference toFIGS. 7-12.

FIG. 7shows step1, the starting position, where the connector halves2,3of the sterile connector1have been removed separately from their respective sterile transport and storage packages and where the connecting tubes (not shown) are connected to the respective nipples6.

In step2, seeFIG. 8, protective covers21over the sealing elements11,12on the connecting means4,5of the connector halves2,3are each removed by means of an opener22with a pull ring23. Step3inFIG. 9is now reached.

Step4is shown inFIG. 10, where the connector halves2,3are articulated to each other by a hinge24by snap action.

FIG. 11illustrates step5, where the connecting planes9of the connecting means4,5of the connector halves2,3are moved into engagement with each other by pivoting the connector halves towards each other via the hinge24until the first connector half2with its outer free end snaps under a locking sleeve25which is longitudinally guided on the second connector half3.

In step6, the final position, shown inFIG. 12, the final interconnection of the connector halves2,3and their components is provided by the locking sleeve25being moved onto the first connector half to a distinct end position. At the same time the protective films13covering the sealing means11,12and the openings8of the connecting means4,5, are removed via drivers26by the locking sleeve25when this is moved and the sealing means and, thus, the openings8are pressed against each other, sealed against contamination.

A particularly preferred embodiment of the invention has been described and illustrated above, where the volume of the recesses16,17is reduced when the sealing elements11,12are moved into engagement and pressed against each other, sealed against contamination (steps5,6above) so that the gas pressure in the recesses is increased and the gas, in the removal of the protective films13, flows out in the environment to prevent contamination of the openings8.

As an alternative to that embodiment, instead a volume increase of the recesses16,17is provided, when the sealing elements are moved into engagement with each other, thus providing a decrease of the gas pressure therein. In this way, an underpressure is created relative to the pressure in the openings, so that gas is sucked out from the same; this too prevents contamination of the openings8. The volume increase/pressure decrease can be achieved, for instance, by means such as elastic bellows, telescopic tubes etc, which are expanded in some other manner when the sealing elements11,12are moved into engagement with each other.

It goes without saying that the invention should not be considered limited to the embodiment described above and illustrated in the drawings, with its described variants and alternatives, and can be modified in various ways within the scope of that stated in the appended claims.