EP2879489A1

EP2879489A1 - Sealed container and packaging method implementing such a container

Info

Publication number: EP2879489A1
Application number: EP13745613.3A
Authority: EP
Inventors: Clément PASCAL; Benoît BARROU
Original assignee: E3 Cortex
Current assignee: E3 Cortex
Priority date: 2012-07-31
Filing date: 2013-07-25
Publication date: 2015-06-10
Also published as: FR2994163B1; WO2014019942A1; FR2994163A1

Abstract

The invention relates to a container (1) made of a flexible plastic material and defining two adjacent spaces (5, 6), a sealing member extending between the two spaces in order to form a sealed border (4) therebetween, wherein a first space (5) comprises, at the end thereof that is opposite the second space (6), a device (2) for opening and sealingly closing a first access to the first space, the second space being shaped such that a cut passing through the second space parallel to the sealing member (4) releases two graspable portions of the container, which are spaced apart from each other such that the sealed border between the two spaces is excised so as to form a second access to the first space that is different from the first access. The insertion of a container for biological material (e.g. a graft) via the first access and the withdrawal thereof via the second access reduce the contamination of the vessel.

Description

Hermetic container and method of packaging using such a container

FIELD OF THE INVENTION

The present invention relates to the field of packaging and more particularly the packaging of biological materials such as grafts or samples for diagnostics.

STATE OF THE ART

The delivery of grafts requires particularly strict hygiene and temperature conditions in order to keep the graft in a state of being implanted. The conventional graft delivery procedure comprises a first explantation step in which the graft is taken from a donor under aseptic conditions, usually in the operating room. The graft is then placed in a sealed pot which is placed in a first plastic bag hermetically closed by a clip closure. Such a clip closure generally comprises a male section of substantially circular cross-section, of flexible plastic material, and a female section of cross-section C, rigid plastic material. The two plastic sheets forming the liner are placed between the female profile and the male profile which is then resiliently engaged (clipped) into the profile C. All known and closure is then placed in a second plastic OUTSIDE know ^¬ higher of same type and closed in the same way. The whole is placed in an insulating transport cooler filled with a refrigerant substance (for example ice and / or eutectic gels) which makes it possible to maintain the graft at a temperature slightly above 0 °. The covers covering the sealed pot preserve the graft from any contact with the refrigerant substance and the ambient air potentially carrying germs. Arrived at destination, the group consisting of the two and the jar containing the graft is removed from the insulating transport cooler and introduced into the implantation room, which is also aseptic. The outer plastic bag is then opened and rolled up around the pot / first plastic bag assembly. The first plastic bag is then opened and rolled up on the outer bag. This maneuver is intended to prevent the liquid resulting from the melting of the refrigerant substance (for example water from melting ice) and has on the outside of the bags can contaminate the graft when it is extracted from the sealed pot. The pot is then opened and the graft is removed for implantation. Despite these precautions, it is found that the grafts still suffer contamination from the refrigerant substance. Indeed, the clip closures of the bags are positioned slightly behind the edges they close to ensure that the two sheets are well pinched by the device. This withdrawal forms a zone of liquid retention which then contaminates the second known. This contamination can be found in contact with the container containing the graft and contaminate it. Similarly, it happens that, during transport, the rigid tubular section C of the first know comes perforate the outer knowledge, making ineffective the protection of the first know by the outer knowledge. In order to solve this problem, it has been contemplated that the hermetic seal includes a glued flap. However, such flaps require a cutting tool to be open and provide a seal of lower quality.

OBJECT OF THE INVENTION

An object of the invention is to reduce the contamination of a graft resulting packaging operations, transport and unpacking thereof.

SUMMARY OF THE INVENTION For this purpose, there is provided, according to the invention, a flexible plastic container defining a first sealed internal volume called useful volume and a second sealed volume called reserve volume adjacent to the first volume, a sealing member extending between both volumes to define a hermetic border between the two volumes. The first volume has at its end opposite the second volume a device for opening and sealing a first access to the first volume, the second volume being shaped so that a cut through the second volume, releases two prehensile portions of the container whose spacing removes the hermetic boundary between the two volumes to form a second access to the first volume distinct from the first access.

Thus, the cutting of the reserve volume protects the sealing element from any retention of liquid from the refrigerant substance. In particular, the possible traces of liquid remain on the outer wall of the container, the inside of the prehensile portions (and therefore the sealing element) being preserved from any pollution ^¬ tion. The spacing of the prehensile portions ensures that no pollution can migrate to the sealing member. The introduction of the content by a first access and its extraction by a second access preserves the content by preventing it from being exposed to possible contamination of the first access that would have occurred during packaging operations.

Advantageously, such a container is made by superposition of two sheets of flexible plastic material having free edges secured together. In this way, the container can be easily made to the dimensions of the contents.

The secured edges of the plastic sheets can be secured by means of links peelable. This then allows, by simple pulling, a corolla opening of the bag over its entire length and releases the contents without it being necessary to roll up the package around the pot.

Advantageously, the sealing element comprises a peelable connection between two plastic surfaces. This design reduces container manufacturing costs by using a weld rather than a clip closure.

The invention also relates to such a container comprising at least one initiation zone of a cutout of the second volume. This eliminates the use of cutting tools for cutting the second volume and thus reduces the risk of contamination associated with this tool.

According to a particularly interesting aspect, the airtight closure device is of the slide type, which again makes it possible to eliminate any tool for closing the container. In addition, the zipper is a simple, robust and reliable means of sealing. This system, involving only flexible elements, reduces the risk of perforation of an outer bag by the first, in the case of double packaging.

The invention also relates to a method for protecting a biological material container of the graft type using a container according to claim 1 and comprising the following steps:

To protect the container:

- open the hermetic opening and closing device;

introducing the biological material container into the container through a first access of the container;

-close the device for opening and closing the container;

To release the container: -cutting the container through the second volume;

at the level of the cut, to grasp two prehensile portions of the container;

to separate these portions from one another so as to break the hermetic border;

remove the biological material container from the container by the second access thus created.

Other features and advantages of the invention will emerge on reading the following description of particular non-limiting embodiments of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

Reference will be made to the appended figures, among which:

FIG 1 is a schematic overview of a particular embodiment of the container 1 according to the invention;

FIG 2 is a view identical to that of Figure 1, the container hosting a content;

FIG. 3 is a view identical to that of FIG. 1, the container being placed in an insulating transport cooler;

- Figure 4 is a view identical to that of Figure 1, the container being in a first step of extracting its contents;

Figure 5 is an axial vertical sectional view of the container of Figure 1, the container being in a second step of extracting its contents;

- Figure 6 is a view identical to that of Figure 1, the container being in a third step of extraction of its contents;

- Figure 7 is a view identical to that of Figure 1, once the content extracted from the container.

DETAILED DESCRIPTION OF THE INVENTION Referring to Figures 1 to 7, and according to a particular embodiment of the invention, the container, generally designated 1, here comprises two rectangular plastic sheets 20 and 30 whose free edges face each other - the long free edges 21 and 23 of the sheet 20 face the long free edges 31 and 33 of the sheet 30 while the short free edges 22 and 24 of the sheet 20 face the short free edges 32 and 34 of the sheet 30. Three of the edges Here, the free edges 21, 22 and 23 which face the free edges 31, 32, 33 are joined to each other by hermetic welding. These welds are so-called "peelable" welds, that is to say which constitute a bond that can be broken by the dry route without causing tearing, tearing or breaking of the bonded elements. The realization of this type of welding is known per se.

The fourth edges 24 and 34 of the sheets 20 and 30 are joined to each other by a ziploc type zipper device 2, each element 2.1 and 2.2 of the slideway 2 being welded facing the of the other on the sheets 20 and 30. The junctions of the four edges of the sheets 20 and 30 then define a hermetic interior volume 3 of the container 1. A peelable weld joining the sheets 20 and 30 between them extends parallel to the zipper 2 from the junction weld long edges 21 and 31 to the junction weld long edges 23 and 33. This weld constitutes a sealing member 4 which defines a hermetic boundary separating the sealed internal volume 3 in a first airtight inner volume 5 called working volume and a second interior volume hermé ^¬ tick 6, adjacent to the first volume, called reserve volume. The useful volume 5 is thus between the two flexible sheets 20 and 30 and delimited by the closure at slide 2 and the sealing element 4 as well as the weld portions solidarisant the long edges 23,33 and 21,31 which are between the zipper 2 and the sealing element 4. The zipper 2 thus closes a first access to the useful volume 5.

The reserve volume 6 is meanwhile included between the two flexible sheets 20 and 30 and delimited by the sealing element 4 and the weld joining the edges 22, 32 together with the weld portions solidly fastening the edges 23, 33 and 21, 31 which are between the zipper 2 and the sealing element 4. These portions of welds each comprise a primer 7 of a cut of the reserve volume in the form of a notch in a half circle .

According to an advantageous embodiment, the plastic sheets 20 and 30 comprise a flexible polyethylene underlayer on which is molded a polyamide film. Advantageously, the plastic sheets comprise a sub-layer of 70 microns of flexible polyethylene on which is molded a film of 20 microns of polyamide. Preferably, the polyethylene underlayer has a thickness of 75 microns and the polyethylene film has a thickness of 30 microns. According to a particular embodiment, the container 1 is sterilized at the end of its manufacture. The outer surfaces of the plastic sheets 20 and 30 and the working volume 5 are then sterile.

The preferred use of such a container is now described with reference to FIGS. 2-7.

During a sampling, the biological material - here a graft 8- is placed in a sealed container, here a cylindrical pot 9. With reference to FIG. 2, the container 1 is placed above the pot 9 and the zipper 2 is open. The pot 9 is introduced into the container 1 by this first access, the container 1 being The pot 9 thus packaged in the container 1 is then placed in an insulating transport cooler 10 in the middle of a refrigerant substance 11 constituted, here, of ice and eutectic gel.

The extraction of the pot 9 of the container 1 is described with reference to FIGS. 4 to 7. At the end of its transportation, the container 1 and its container 9- the pot are removed from the insulating cooler 10. The outside of the container 1 is generally covered with liquid from its contact with the refrigerant 11 and / or condensation of ambient humidity thereon. The container 1 is then cut in a direction parallel to the sealing element 4 at the level of the reserve volume 6, over its entire width. Such cutting can be performed without tools by tearing the reserve volume 6 with the aid of the cutting primers 7 along a line shown in dashed lines in FIG. 4. The container 1 then presents, at this level cutting the reserve volume 6, two ends 25 and 35 respectively plastic sheets 20 and 30- whose inner face is free from any contamination by the refrigerant 11. In fact, the interior of the volume 6 being hermetically sealed during transport operations, it has been preserved from any contamination, especially from refrigerant 11. The edges of plastic sheets 20 and 30 which have just been cut do not contain any trace of liquid likely to s' accumulate at the sealing element 4 and contaminate the pot 9.

The ends 25 and 35 constitute two gripping portions of the sheets 20 and 30 of the container 1. In order to access the useful volume 5, and with reference to FIG. 5, an operator grasps the two prehensile portions 25 and 35 of the container 1 and the away from each other. This has the effect of separating leaves 20 and 30 from and remove the hermetic boundary defined by the sealing element 4. This situation is illustrated in Figures 6 and 7. The removal of the hermetic boundary forms a second access to the useful volume 5 by which the pot 9 is extracted. This second access makes it possible to extract the pot 9 from the container 1 by a separate access from the first port through which it was introduced into the container 1, which greatly improves the health safety of the latter. Indeed, each manipulation of the container (here pot 9) is considered as representing a potential source of contamination. Thus, the introduction of a container into a container can pro ^¬ vaquer the contamination of the access by which it was introduced. The extraction of the container by the same access then exposes the container again to this possible contamination. This risk of contamination is eliminated by the packaging method and the packaging according to the invention.

The applicable standards, in particular ISO 11607, requiring a systematic double packaging, the assembly constituted by the pot 9 packaged in the container 1 can be placed in a second container 100 identical to the con ^¬ content 1. The operations of introduction and extraction of the container will then be repeated twice.

Of course, the invention is not limited to the embodiments described but encompasses any variant within the scope of the invention as defined by the claims.

In particular,

although here, the sealing element 4 defined ^¬ between the hermetic border between the reserve volume and the useful volume is a peelable weld, the invention also applies to other types of elements of such as, for example, a ziploc zipper, a clamp-held bend, magnets molded opposite each other in the plastic sheets;

- Although here the container consists of two flexible sheets of plastic whose free edges are welded together, the invention also applies to a container made from one or more plastic sheets. Thus, the container may be made by folding a single plastic sheet and welding one on the other of its free edges. The container may also include three or more sheets with their edges joined. The container may finally also be made from a closed plastic tube comprising a transverse weld;

- Although here the container comprises two interior volumes, the invention also applies to a container comprising more interior volumes, such as for example a container comprising additional volumes adjacent to the reserve volume and able to receive, for example, an identification tag, traceability means or means of tracking the routing conditions;

although here the container here comprises a polyethylene sheet, the invention also applies to a container made of other materials such as for example polypropylene or polyamide;

- Although here the cutting of the reserve volume is in a direction parallel to the sealing element and over the entire width of the reserve volume, the method according to the invention also applies to a cut through the reserve volume preserving the sealing element while generating two prehensile portions;

although here all the junction welds of the free edges are peelable welds, the invention also applies to a container which does not taking only one peelable weld, such as, for example, the weld forming the sealing element between the two interior volumes;

- Although here the cutting primers of the second volume here are notches in the form of semicircle, the invention also applies to other types of cutting primer such as, for example, a straight cut, contiguous perforations or under thickness.

Claims

1. Container (1) of flexible plastic material defining a first volume (5) airtight interior called useful volume and a second volume (6) hermetic called reserve volume adjacent to the first v ^¬ lume, a sealing element (4) ) extending between the two volumes to define a hermetic boundary between the two volumes, the first volume (5) having at its end opposite the second volume (6) a device for opening and sealing (2) a first access to the first volume (5), the second volume (6) being shaped so that a cut through the second volume (6), releases two prehensile portions (25, 35) of the container whose spacing removes the hermetic border (4) between the two volumes (5, 6) to form a second access to the first volume (5) distinct from the first access.

Container according to claim 1, wherein the useful volume (5) is sterile.

3. Container (1) according to claim 1, réali ^¬ by superposition of two sheets (20,30) of flexible plastic material having free edges (21, 22, 23, 31, 32, 33) joined together.

4. Container (1) according to claim 3, the secured edges (21, 22, 23, 31, 32, 33) are secured with peelable bonds.

Container according to one of the preceding claims, wherein the sealing element (4) comprises a peelable connection between two plastic surfaces (20, 30).

Container (1) according to claim 1, comprising at least one primer (7) of a cutout of the second volume (6).

The container (1) according to claim 1, wherein the hermetic seal (2) is slide type.

8. Container (1) according to claim 1, comprising an interior volume (3) defined by two rectangular plastic sheets (20,30) joined by welding to one another in three of their four edges and whose a small edge (24, 34) carries an opening and sealing device (2), a transverse weld (4) separates the inner volume (3) into a first (5) and a second (6) volume, all the welds being peelable.

Container according to any one of the preceding claims, wherein the plastics material comprises polyethylene and / or polyamide.

A method of protecting a biological material container (9) of the graft type employing a container (1) according to claim 1 and comprising the steps of:

To protect the container:

- open the hermetic opening and closing device (2);

- introducing the container (9) biological material (8) in the container (1) by a first access of the container (1);

-close the device for opening and sealing (2) of the container;

To release the container:

-cutting the container (1) through the second volume (6);

at the level of the cut, enter two prehensile portions (25, 35) of the container (1);

spacing these portions (25, 35) from one another so as to break the hermetic boundary (4);

-Remove the container (9) biological material (8) of the container (1) by the second access thus created.