METHOD AND DEVICE FOR CREATING AN ENVIRONMENTALLY SEALED CONNECTION BETWEEN TWO REGIONS

Abstract

A method and device for creating an environmentally sealed connection for transfer between a first region and a second region, the first region and the second region each having an at least partially flexible barrier with connection portions, comprising the following steps: (i) superposition of said connection portions of the barriers in a sandwich arrangement, wherein each connection portion comprises a first area at least partially made of thermo-resistant material and a second area comprising a first welding band zone of a closed geometrical shape, said first and second area of each barrier being arranged to face one another, with the first areas of the two barriers forming the outside layers of the sandwich arrangement, and the second areas of the two barriers forming the inside layers of the sandwich arrangement, wherein the first areas are positioned to cover the first welding band zones of the second zones, (ii) joining the second areas by welding of the first closed welding band zones, whereby a first separation line, comprised inside and along the length of the first welding band zone, is cut as a result of the welding and whereby the barrier areas enclosed by the separation line are welded along their edges to form an insert, which becomes detached from the at least partially flexible barriers, and (iii) distancing the first areas of the super-positioned connection portions from each other, for example by pulling them apart, thereby revealing an opening confined by the welded seam connecting the second areas of the at least partially flexible barriers and joining the first region with the second region.

Claims

1. Method of creating an environmentally sealed connection for transfer between a first region and a second region, the first region and the second region having each an at least partially flexible barrier separating the first region, respectively the second region from a third external region, the at least partially flexible barriers having each a connection portion with a first area at least partially made of thermo-resistant material and a second area with a first welding band zone of a closed geometrical shape, the method comprising the following steps: superposition of said connection portions of the barriers in a sandwich arrangement, said first area and second area of each barrier being arranged to face one another, with the first areas at least partially made of thermo-resistant material of the two barriers forming the outside layers of the sandwich arrangement, and the second areas of the two barriers forming the inside layers of the sandwich arrangement, wherein the first areas are positioned to cover the first welding band zones of the second zones, joining the second areas by welding of the first closed welding band zones, whereby a first separation line, comprised inside and along the length of the first welding band zone, is cut as a result of the welding and whereby the barrier areas enclosed by the separation line are welded along their edges to form an insert, which becomes detached from the at least partially flexible barriers, distancing the first areas of the super-positioned connection portions from each other, thereby revealing an opening confined by the welded seam connecting the second areas of the at least partially flexible barriers and joining the first region with the second region.

2. Method according to claim 1 comprising transfer of objects, such as equipment, goods or material, as well as organisms, chemical or biological matter from the first region to the second region through the opening.

3. Method according to claim 1, wherein, subsequent to the transfer, the at least partially flexible barriers of the first region and the second region are separated by welding along a second welding band zone and cutting along a second separation line, whereby the second separation line is positioned inside the second welding band zone, preferably approximately centrally.

4. Method according to claim 1, wherein the first region is a closed container, preferably a bag.

5. Method according to claim 1, wherein the second region is a room or a chamber of a defined environmental setting, which can be open or closed.

6. Method according to claim 1, wherein the at least partially flexible barrier of the second region is an endless tubular liner comprising a plurality of connection portions serially arranged throughout its length.

7. Method according to claim 6, said tubular liner being positioned around an air lock structure of the second region through which the material or equipment can be transferred, wherein the endless tubular liner is progressively pulled to permit successive use of the serially arranged connection portions for transfer.

8. Method according to claim 4, wherein the at least partially flexible barrier of the second region is an endless tubular liner comprising a plurality of connection portions serially arranged throughout its length.

9. Method according to claim 8, said tubular liner being positioned around an air lock structure of the second region through which the material or equipment can be transferred, wherein the endless tubular liner is progressively pulled to permit successive use of the serially arranged connection portions for transfer.

10. Method according to claim 1, wherein the barriers are separating a contaminated third external region from the uncontaminated or sterile, first region and second region.

11. Method of creating an environmentally sealed connection for transfer between a first region and a second region, the first region and the second region having each an at least partially flexible barrier separating the first region, respectively the second region from a third external region, the at least partially flexible barriers having each a connection portion with a first area at least partially made of thermo-resistant material and a second area with a first welding band zone of a closed geometrical shape, wherein the second at least partially flexible barrier is partially formed by a tubular endless liner with a plurality of connection portions serially arranged throughout its length, the method comprising the following steps: superposition of said connection portions of the barriers in a sandwich arrangement, said first area and second area of each barrier being arranged to face one another, with the first areas at least partially made of thermo-resistant material of the two barriers forming the outside layers of the sandwich arrangement, and the second areas of the two barriers forming the inside layers of the sandwich arrangement, wherein the first areas are positioned to cover the first welding band zones of the second zones, joining the second areas by welding of the first closed welding band zones, whereby a first separation line, comprised inside and along the length of the first welding band zone, is cut as a result of the welding and whereby the barrier areas enclosed by the separation line are welded along their edges to form an insert, which becomes detached from the at least partially flexible barriers, distancing the first areas of the super-positioned connection portions from each other, thereby revealing an opening confined by the welded seam connecting the second areas of the at least partially flexible barriers and joining the first region with the second region.

12. A device for transferring material or equipment avoiding contamination, comprising a connection portion having a first area at least partially made of thermo-resistant material, and a second area, wherein the second area is weldable to an area with equivalent physical properties, under predetermined welding conditions, whereas the first area is not weldable to said second area under the predetermined welding conditions.

13. A device according to claim 12, whereby the first welding band zone can be welded using an impulse welding procedure at temperatures ranging between 250° C. and 120° C., or between 200° C. and 100° C.

14. A device according to claim 12, wherein the device is made from weldable plastic material, such as polyethylene (PE), and the first area is made of polyethylene terephthalate (PET) or has a PET layer.

15. A device according to claim 12, wherein the device is a bag, or an endless liner, or an endless liner comprising a plurality of connection portions serially arranged throughout its length.

16. An endless liner for transferring material or equipment avoiding contamination, comprising a plurality of connection portions serially arranged throughout its length, wherein said connection portions each have a first area, which is at least partially made of thermo-resistant material, and a second area, wherein the second area is weldable to an area with equivalent physical properties, under predetermined welding conditions, whereas the first area is not weldable to said second area under the predetermined welding conditions, thereby being capable of creating an opening around its entire perimeter a welded seam when the second area is welded to an area with equivalent physical properties.

17. Use of the method according to claim 1 for the sterile transfer of medical equipment, such as syringes, catheters, surgical implants or instruments, and other consumables or tools, from a sterile packaging bag to a clean room area or chamber.

18. Use of the device according to claim 12 for the sterile transfer of medical equipment, such as syringes, catheters, surgical implants or instruments, and other consumables or tools, from a sterile packaging bag to a clean room area or chamber.

19. Use of the method according to claim 1 for transfer lifeforms, including humans, animals, plants and microbes, as well as biological material, samples and organs, between a first region and a second region of defined environmental conditions, whereby said regions are separated from the environmental conditions of a third external region by means of their barriers.

20. Use of the device according to claim 12 for transfer lifeforms, including humans, animals, plants and microbes, as well as biological material, samples and organs, between a first region and a second region of defined environmental conditions, whereby said regions are separated from the environmental conditions of a third external region by means of their barriers.

21. A welding device capable welding the first welding band zones of the at least partially flexible barriers, which confine the first region and second region, by carrying out the method according claim 1, comprising: A working surface designed to support the joinable and separable barriers and a countersurface for applying pressure to the connection portions, an electrical device for temperature-controlled heating of a first welding stamp of closed geometrical shape suited to connect the first welding band zones and located on the working surface and the counter surface, the first welding stamp, a first separation wire suited to cut the welded barriers along the first separation line and situated inside and along the entire length of the first closed welding stamp, positioning pins for arranging the connection sections of the barriers in suitable sandwich formation, and, optionally, a second of linear welding stamp with a second separation wire, wherein the welding stamp and separation wire are positioned outside the closed shape of the first welding stamps and are suited for sealing and cutting to separate the at least partially flexible barriers.

Description

SHORT DESCRIPTION OF THE DRAWINGS

[0041] Exemplar embodiments of the invention are disclosed in the description and illustrated by the drawings in which:

[0042] FIGS. 1A, 1B are cross sectional views of the barriers enclosing the first and the second regions, with

[0043] FIG. 1A schematically representing a bag enclosing the first region with an object for transfer, and

[0044] FIG. 1B schematically representing an endless-liner barrier of the second region integrated in an airlock system.

[0045] FIGS. 2A, 2B schematically show the connection portions of the barriers, with

[0046] FIG. 2A showing a top view of a second zone 42 of the connection portion 40 with the virtual welding band zone 44, and

[0047] FIG. 2B showing a cross sectional side view of the aligned connection portions 402, 403 for welding

[0048] FIGS. 3A-3D demonstrate the procedural steps of the separation welding procedure joining two areas with cross sectional views, wherein

[0049] FIG. 3A illustrates the alignment of the connection portions of a bag confining the first region and a containment barrier of the second region,

[0050] FIG. 3B illustrates the first welding band zones in which the aligned connection portions will be welded as part of the separation welding procedure,

[0051] FIG. 3C illustrates the welded and cut first welding band zones and the detachment of the insert,

[0052] FIG. 3D illustrates the subsequent optional step of disconnecting the two joined regions using separation welding.

[0053] FIGS. 4A, 4B are schematic top views of

[0054] FIG. 4A a sealed bag with a connection portion and

[0055] FIG. 4B an endless liner with serially arranged connection portions;

[0056] FIG. 5 is a perspective view of the welding device;

[0057] FIG. 6 is a perspective view of the welding device suitably positioned next to an air lock system of the second region in preparation of the procedure

EXAMPLES OF EMBODIMENTS OF THE PRESENT INVENTION

[0058] With reference to FIGS. 1A, 1B, a schematic cross section of a preferred embodiment of the at least partially flexible barriers 22, 32 confining two separate regions 25, 35 to be joined is shown. FIG. 1A exemplifies a first enclosed region 25 with a content 97, in this case a flask, for transfer. The first region 25 is confined by a sealed bag 20, which comprises a connection portion 40. The sealed bag separates the first region 25 from the external environment 200.

[0059] FIG. 1B shows a schematic cross section of a preferred embodiment of the at least partially flexible barrier 32 confining the second region 35. In this example, the barrier is at partially formed by an endless liner 30, which is connected to an air-lock structure 55 comprising an air lock door 57 and an air lock opening 56. The endless liner 30 is connected to the opening along a liner attachment zone 59. This attachment zone 59 constitutes a hermetic connection between liner 30 and air lock structure 55. This attachment zone 59 forms part of the environmental barrier between the second region 35 and the external environment 200. To this end the attachment zone 59 follows uninterruptedly a closed band or line along the confining wall of the air lock opening 56. The attachment zone 59 may be positioned along the inner surface of said wall. It may also be positioned along the outer surface of said wall. Alternatively, the endless liner 30 may be hermetically connected to a different suitable part of the air lock structure 55.

[0060] An additional containment element 58 suited to contain the assembled endless liner 30 is preferably connected to the air-lock structure 55. The liner 30 may be folded, rolled, compressed inside this containment element 58. Other assembly arrangements suited to decrease the volume of the endless liner 30 are possible.

[0061] The invention is not limited to the above described embodiments. The bag may be replaced by another confining at least partially flexible barrier 22 for a first region 25, such as a container, a chamber, a room or a protective suit. Other examples are conceivable.

[0062] The second region may be limited by an at least partially flexible barrier 32 enclosing a container, a chamber, a room or an open region. If the second region is an open region, it is separated from the external environment by a separation barrier, which may be a wall. If the second region is an open region, the external environment is an enclosed region confined by barriers.

[0063] The barrier of the first region 22 and the barrier of the second region 32 each comprise connection portions 40. In FIGS. 1A and 1B the connection portions 402 of the bag 20 and the connection portion 403 of the endless liner 30 are shown.

[0064] Each connection portion 402, 403 includes a at least partially thermo-resistant first area 412, 413 which is at least partially made from material which is not weldable under predetermined welding conditions, at which the second area 422, 423 comprised by the connection portion is weldable. By way of example, predetermined welding conditions may be welding temperatures between 250° C. and 120° C., or between 200° C. and 100° C. In this case, the material must be able to withstand the heat above 200° C., or above 250° C. In particular, the material must not lose its physical integrity at the predetermined welding conditions. In the exemplified case, the material must furthermore be suited to transfer sufficient heat from the welding stamp 605 of the welding device 600 to the first welding band zones 44 (FIGS. 2A, 4A) of the connection portions 402, 403 to enable separation welding of the first welding band zones 44. Such material may be a thermo-resistant plastic material, preferably a polyethylene terephthalate (PET) material.

[0065] In a preferred embodiment the at least partially thermo-resistant first area 412, 413 is a two layer film comprising a thermo-resistant PET layer at the inner surface, i.e. the second area 422, 423 facing surface, of the connection portion 40, and a weldable layer, for example a polyethylene (PE) layer at the outer surface, i.e. the external environment 200 facing surface, of the connection portion 40. This arrangement permits welding of an insertable first area 412, 413 to the surrounding material of the at least partially flexible barrier, as mentioned below.

[0066] Alternatively, a thermo-resistant layer, for example a PET layer, can be affixed to the inner surface of the first area 41, i.e. the surface facing the second area 42, for example by means of a bonding agent.

[0067] The first at least partially thermo-resistant area 412, 413 may be an area, which is inserted into the at least partially flexible barrier. An area of the at least partially flexible barrier may be removed and replaced by the inserted at least partially thermo-resistant area 412, 413. The inserted first area 41 is attached to the barrier along an attachment zone 43 which follows the perimeter of the at least partially thermo-resistant area 412, 413. The connection between the barrier and the first area 412, 413 is a hermetic connection. Said hermetic connection may be a welded or a glued connection. Other forms of hermetic connections are conceivable.

[0068] Each portion 402, 403 furthermore includes a second area 422, 423, which is located in an area of the respective barrier, which is opposite the first area 412, 413. The second areas 422, 423 are facing the first areas 413, 412.

[0069] A schematic top view of a second area is shown in FIG. 2A. The second area comprises a virtual first welding band zone 44, which includes a virtual separation line 45. The first welding band zone 44 is of a closed geometrical form. The shape of the first welding band zone 44 is defined by the shape of the first welding stamp 605. The outline of the separation line 45 is defined by the outline of the first separation wire 606 (FIG. 2B). The separation line 45 is located inside and along the entire length of the first welding band zone 44. The first welding band zone 44 of the second area is made from material which is weldable to material of the same or similar physical properties at predetermined welding conditions, for example at temperatures between 250° C. and 120° C., preferably between 200° C. and 150° C. Welding band zones 44 can be welded to each other at temperatures between 250° C. and 120° C., preferably between 200° C. and 150° C. Suitable material for first welding band zones 44 are, by way of example, PE plastics.

[0070] Preferably the first welding band zone 44 and the second area are made of the same material. Preferably the second area 42 is made of the same material as the surrounding area of the barrier 22, 32.

[0071] Welding band zones 44 are welded employing a separation welding method. During the cut ‘n’ seal welding step the welded areas are cut along the separation line 45. Preferably, said separation welding method ensures that the cut edges of the welded zones are sealed off with a welded seam 47.

[0072] Preferably the welding method is impulse welding. Welding temperatures range from 250° C. to 120° C., or from 200° C. to 100° C.

[0073] In an alternative embodiment the welding method is ultrasonic welding.

[0074] The shape and size of the connecting opening 80, which is generated as part of the separation welding step, is defined by the size and shape of the welding zone band 44. As a consequence, is a wider opening is desired for a particular application, the size of the welding zone band 44 needs to be adjusted accordingly.

[0075] In FIG. 2B the sandwich arrangement 100 of the connection portions 402, 403 of the second and first barriers is shown in a schematic cross section. The working surface 601 and the counter surface 602 of the welding device 600 are also shown. The counter surface comprises a welding stamp 605 with a separation wire 606, wherein the size and shape of the welding stamp corresponds to the size and shape of the first welding band zone 44. The counter-surface may be covered by non-stick layer 607, for example Teflon. The work surface is ideally covered by a soft, thermo-resistant 608, for example a silicon layer.

[0076] Positioning the two connection portions 402, 403 of the respective barriers in the demonstrated sandwich position in the welding device, is a first step in the separation welding process. Importantly, the first areas 412, 413 and the second areas 422, 423 must be super-positioned, wherein the second areas 422, 423 form the inner layers of the sandwich arrangement and the first areas 412, 413 form the outer layers of the sandwich arrangement 100. At a minimum the first areas 412, 413 cover the entire area of the first welding band zones 44.

[0077] The individual steps of the cut ‘n’ seal welding process are exemplified in FIGS. 3A-3D. FIG. 3A shows the super-positioned connection portions 402, 403 of the barriers 22, 32 of a first region 20 and a second region 30, which are to be joined. Once arranged in this way, the separation welding step, for example impulse welding, can be conducted.

[0078] As a result of this step a welding seam 47 a separating cut along the separation line are generated. A cross sectional view of the closed welding seam 47 is shown in FIG. 3B. The position of the separation line 45 is indicated by arrows.

[0079] An insert 50 is detached from the joined barriers. As a result of the location of the cut inside the welding seam 47, both, the entire perimeter of the insert 50, as well as the entire perimeter of the opening 80 are sealed by portions of the generated welding seam. The barriers of the first and the second regions 22, 32 are fused together by the welding seam 47. The welding seam 47 at the joined barriers 22, 32 describes an opening 80 which between the first 20 and the second 30 region.

[0080] The edges of the two walls of the insert 50 are fused together by the welding seam 47. The inside of the insert contains a part of the external environment 200. Once removed from the opening 80, the insert 50 is situated within the joined first and second regions 25, 35. In order to avoid exposure to the external environment, it is therefore essential, that the welding seam 47 seals the part of the external environment securely within the volume contained inside the insert 50.

[0081] No additional step is required to detach the cut insert 50 from the joined barriers 22, 32. However, pulling apart of the outer surfaces of the sandwich arrangement may help to remove the cut insert 50 from the opening 80.

[0082] As an optional subsequent step shown in FIG. 3D, the two regions can be separated again by an additional separation welding step along a second welding band zone 65, which comprises a separation line and is positioned in such a way that is can cut the barrier to separate two regions. Preferably, the edges of each region along the cut line 67 are sealed by a welding seam 47. The separation welding is performed in such a way that the second region 35 is securely sealed from the external environment 200.

[0083] Referred devices for the procedure described above are shown in FIGS. 4A, 4B. FIG. 4A is a schematic top level view of a section of a flattened endless liner 30. Preferably the endless liner has an essentially tubular shape. The endless liner is of flexible material, for example PE plastic, and can be flattened into a flattened position which is shown in FIG. 4A. The endless liner comprises multiple connection portions 40, which are arranged serially, preferably at intervals, along the length of the endless liner 30. In its flattened position, the first area 413 and second area 423 (shown in FIG. 2B) of each connection portions 40 or super-positioned. The endless liner may have two connection seams 33, for example as a result of gluing or welding, along each of the longitudinal sides of the flattened liner. These connection seams 33 are a barrier between the portion of the liner, which comprises the connection portions 40 and which acts as a barrier for the second region 35, and external portions 31. The external positions 31 may comprise positioning points 34, which serve assist the correct positioning of the connection portion 40 in the welding device 600 in preparation of the separation welding process.

[0084] FIG. 4A shows the connection portion 40 and indicates the shape of the virtual first welding band zone 44 upon which the heat of the welding stamp 605 will be applied during the described procedure.

[0085] In a preferred embodiment the first region 25 is confined in a sealed bag 20, such as schematically illustrated in FIG. 4B. This figure shows a flattened top level view of the empty bag with the connection portion 40, connection seams 33 along its sides and positioning points 34. The positioning points 34 are situated, such that super-position of the positioning points 34 of the bag with the positioning points of the endless liner ensures proper alignment of the connection portions 40 for welding. To assist this alignment the welding device 600 may be equipped with positioning pins 609, suited to hold the positioning points 34 in place during the welding process.

[0086] FIG. 5 is a schematic presentation of a welding device 600. The device comprises A working surface 601 designed to support the joinable and separable barriers and a counter surface 602 for applying pressure to the connection portions 40, an electrical device for temperature-controlled heating of a first welding stamps 605 of closed geometrical shape suited to connect the first welding band zones and located on the working surface 601 and the countersurface 602. The welding device furthermore comprises a first separation wire 606 suited to cut the welded barriers along their separation lines 45. The separation wire 606 (shown in FIG. 2B) is positioned inside and along the entire length of the closed welding stamp 605. The welding device also includes positioning pins 609 for arranging the connection sections of the barriers in suitable sandwich formation and it optionally includes a second linear welding stamp 610, suited for sealing and cutting to separate the flexible barriers. The second linear welding stamp (610) comprises a separation wire and is positioned outside the closed shape of the first welding stamp 605.

[0087] The position of the welding device 600 in relation to an air lock system 55 of a second region 35 without the endless liner or the first barrier is shown in FIG. 6. In this embodiment, the second region 35 is partially confined by a wall, which forms part of the barrier of the second region 32. The second region in this embodiment may be a room or a chamber.

REFERENCE NUMBERS USED IN THE FIGURE

[0088] 20 sealed bag [0089] 22 barrier of first region [0090] 25 first region [0091] 30 endless liner [0092] 31 external portion [0093] 32 barrier of second region [0094] 33 connection seam [0095] 34 positioning points [0096] 35 second region [0097] 40 connection portion [0098] 402 connection portion of barrier enclosing first region [0099] 403 connection portion of barrier enclosing second region [0100] 41 first area [0101] 412 first area of first connection portion [0102] 413 first area of second connection portion [0103] 42 second area [0104] 422 second area of first connection portion [0105] 423 second area of second connection portion [0106] 43 attachment zone of first area [0107] 44 first welding band zones [0108] 442 first welding band zone of first connection portion [0109] 443 first welding band zone of second connection portion [0110] 45 separation line in first welding band zone [0111] 47 welding seam [0112] 50 insert [0113] 55 air lock structure [0114] 56 air lock opening [0115] 57 air lock door [0116] 58 containment element [0117] 59 attachment zone [0118] 65 second welding band zone [0119] 67 cut line [0120] 69 positioning point [0121] 70 longitudinal seals [0122] 80 connecting opening [0123] 97 flask [0124] 100 sandwich arrangement [0125] 200 external environment [0126] 600 welding device [0127] 601 working surface [0128] 602 counter surface [0129] 605 first closed welding stamp [0130] 606 separation wire [0131] 607 non-stick layer [0132] 608 silicon layer [0133] 609 positioning pins [0134] 610 linear welding stamp