MULTI-CHAMBER BAG FOR MEDICAL PURPOSES AND METHOD FOR RECOGNITION OF THE STATE OF A SEPARABLE SEAM OF A MULTI-CHAMBER BAG FOR MEDICAL PURPOSES

Abstract

The invention relates to a multi-chamber bag 1 for medical purposes which is formed by films 2, 3, in particular flexible films, that are arranged against one another, are made of an at least partially transparent material and are interconnected in a liquid-tight manner using at least one non-separable seam 5, the bag being divided into at least two chambers 1A, 1B by at least one separable seam 8, by means of which the films arranged against one another are interconnected in a liquid-tight manner. The multi-chamber bag according to the invention is characterised by at least one visually perceptible structure 10 that signals the state of the at least one separable seam 8 and can be easily optically detected. Using this visible structure 10, the user can immediately identify whether the seam 8 is open or closed. The structure is composed of structural elements 11 which the films 2, 3 arranged against one another comprise in the region of the separable seam 8 and are in a predetermined spatial arrangement relative to one another such that the structural elements in the region of the separable seam complement one another to form the structure signalling the state of the separable seam when the separable seam is closed, such that the films in the region of the separable seam lie against one another in a predetermined orientation, and do not complement one another to form the structure signalling the state of the separable seam when the separable seam is open, such that the films in the region of the separable seam do not lie against one another in a predetermined orientation, meaning that the predetermined spatial arrangement of the structural elements relative to one another in the region of the separable seam no longer exists.

Claims

1. A multi-chamber bag for medical purposes which is formed by films that are arranged against one another, are made of an at least partially transparent material and are interconnected in a liquid-tight manner using at least one non-separable seam, the bag volume being divided into at least two chambers by at least one separable seam, by means of which the films arranged against one another are interconnected in a liquid-tight manner, wherein the multi-chamber bag is provided with at least one visually perceptible structure that signals the state of the separable seam and is composed of structural elements that the films arranged against one another comprise in the region of the separable seam and are in a predetermined spatial arrangement relative to one another such that the structural elements in the region of the separable seam complement one another to form the structure signalling the state of the separable seam when the separable seam is closed, such that the films in the region of the separable seam lie against one another in a predetermined orientation, and do not complement one another to form the structure signalling the state of the separable seam when the separable seam is open, such that the films in the region of the separable seam do not lie against one another in a predetermined orientation, meaning that the predetermined spatial arrangement of the structural elements relative to one another in the region of the separable seam no longer exists.

2. The multi-chamber bag according to claim 1, wherein the structural elements in the region of the separable seam are arranged in a predetermined spatial arrangement relative to one another such that regions of an upper film which comprise the structural elements lie over regions of a lower film which do not comprise the structural elements, and regions of the lower film that comprise the structural elements lie below regions of the upper film which do not comprise the structural elements, such that the structural elements, in the region of the separable seam, complement one another to form the structure signalling the state of the separable seam when the films lie against one another in the region of the separable seam.

3. The multi-chamber bag according to claim 1, wherein the structural elements are transparent regions of the films that are different colours, an upper film having, in the region of the separable seam, at least one transparent region that is a first colour and lies over a transparent region of a lower film that is a second colour, which differs from the first colour such that the structural elements, as the structure signalling the state of the separable seam, are apparent to the viewer in a third colour, which differs from the first and second colour, when the films lie against one another in the region of the separable seam.

4. The multi-chamber bag according to claim 1, wherein the structural elements are designed as patterns, a structural element forming a first pattern being provided on an upper film in the region of the separable seam and a structural element forming a second pattern being provided on a lower film in the region of the separable seam, the first pattern differing from the second pattern such that the structural elements are apparent to the viewer as a third pattern, which differs from the first and second patterns when the films lie against one another.

5. The multi-chamber bag according to claim 1, wherein the structure signalling the state of the separable seam is a word or a series of words or a symbol.

6. The multi-chamber bag according to claim 5, wherein a first part of the word or the series of words or the symbol is provided in a region of an upper film in the region of the separable seam, and a second part of the word or the series of words or the symbol is provided in a region of a lower film that is below the region in which the first part is provided, such that the first and the second part complement one another to form the word or the series of words or the symbol when the films lie against one another in the region of the separable seam.

7. The multi-chamber bag according to claim 1, wherein the structure signalling the state of the separable seam is a machine-readable code composed of a plurality of elements.

8. The multi-chamber bag according to claim 7, wherein the plurality of elements of the machine-readable code in the region of the separable seam are arranged in a predetermined spatial arrangement relative to one another on the films that are arranged against one another such that the elements complement one another to form the machine-readable code when the separable seam is closed, such that the films in the region of the separable seam lie against one another, and do not complement one another to form the machine-readable code when the separable seam is open, such that the films in the region of the separable seam do not lie against one another, meaning that the predetermined spatial arrangement of the elements forming the machine-readable code relative to one another no longer exists.

9. The multi-chamber bag according to claim 1 wherein the structural elements are image elements and/or symbol elements printed onto the films that are arranged against one another.

10. The multi-chamber bag according to claim 9, wherein the image elements and/or symbol elements are circular, arc-shaped, elliptical, square or rectangular elements.

11. A multi-chamber bag for medical purposes which is formed by films that are arranged against one another, are made of an at least partially transparent material and are interconnected in a liquid-tight manner using at least one non-separable seam, the bag volume being divided into at least two chambers by at least one separable seam, by means of which the films arranged against one another are interconnected in a liquid-tight manner, wherein in the region of the separable seam, the multi-chamber bag is provided with at least one visually perceptible structure that signals the state of the separable seam and is formed by regions of films that lie against one another and are designed as polarisers, the structure signalling the state of the separable seam being apparent to the viewer when the separable seam is closed, such that the films in the region of the separable seam lie against one another in a predetermined orientation, and the structure signalling the state of the separable seam not being apparent to the viewer when the separable seam is open, such that the films in the region of the separable seam do not lie against one another in a predetermined orientation, meaning that the predetermined spatial arrangement of the polarisers relative to one another no longer exists.

12. The multi-chamber bag according to claim 1, wherein the chambers of the multi-chamber bag are filled with a medical liquid, preferably with components of a medical solution for infusion or dialysis.

13. The multi-chamber bag according to claim 1, wherein the non-separable seam is a peripheral seam or the bag is made of a film sleeve that is closed by a non-separable seam at both the upper and the lower edge.

14. A method for identifying the state of a separable seam of multi-chamber bags for medical purposes which are formed by films that are arranged against one another, are made of an at least partially transparent material and are interconnected in a liquid-tight manner using at least one non-separable seam, the bag volume being divided into at least two chambers by at least one separable seam, by means of which the films arranged against one another are interconnected in a liquid-tight manner, wherein the multi-chamber bag is provided with at least one visually perceptible structure that signals the state of the separable seam and is composed of structural elements that the films arranged against one another comprise in the region of the separable seam and are in a predetermined spatial arrangement relative to one another such that the structural elements in the region of the separable seam complement one another to form the structure signalling the state of the separable seam when the separable seam is closed, such that the films in the region of the separable seam lie against one another in a predetermined orientation, and do not complement one another to form the structure signalling the state of the separable seam when the separable seam is open, such that the films in the region of the separable seam do not lie against one another in a predetermined orientation, meaning that the predetermined spatial arrangement of the structural elements relative to one another in the region of the separable seam no longer exists, and monitoring the bag using a monitoring device, which comprises an optical read apparatus for detecting the structure signalling the state of the separable seam and comprises an evaluation unit, the evaluation unit being configured such that a signal signalling the state of the separable seam is generated when the structure signalling the state of the separable seam is detected on the bag.

15. The method according to claim 14, wherein the bag is provided with a machine-readable code composed of a plurality of elements that are applied to the films that are arranged against one another in a predetermined spatial arrangement relative to one another in the region of the separable seam such that the elements complement one another to form the machine-readable code when the separable seam is closed, such that the films in the region of the separable seam lie against one another, and do not complement one another to form the machine-readable code when the separable seam is open, such that the films in the region of the separable seam do not lie against one another, meaning that the predetermined spatial arrangement of the elements forming the machine-readable code relative to one another no longer exists, or the bag is provided with a machine-readable code such that the machine-readable code can be identified when the films do not lie against one another in the region of the separable seam, and cannot be identified when the films lie against one another in the region of the separable seam.

16. A method for identifying the state of a separable seam of multi-chamber bags for medical purposes which are formed by films that are arranged against one another, are made of an at least partially transparent material and are welded to one another in a liquid-tight manner using at least one non-separable seam, the bag volume being divided into at least two chambers by at least one separable seam, by means of which the films arranged against one another are interconnected in a liquid-tight manner, wherein in the region of the separable seam, the multi-chamber bag is provided with at least one visually perceptible structure that signals the state of the separable seam and is formed by regions of films that lie against one another and are designed as polarisers, the structure signalling the state of the separable seam being apparent to the viewer when the separable seam is closed, such that the films in the region of the separable seam lie against one another in a predetermined orientation, and the structure signalling the state of the separable seam not being apparent to the viewer when the separable seam is open, such that the films in the region of the separable seam do not lie against one another in a predetermined orientation, meaning that the predetermined spatial arrangement of the polarisers relative to one another no longer exists, and monitoring the bag using a monitoring device, which comprises an optical read apparatus for detecting the structure signalling the state of the separable seam and comprises an evaluation unit, the evaluation unit being configured such that a signal signalling the state of the separable seam is generated when the structure signalling the state of the separable seam is detected on the bag.

17. A system composed of a blood treatment device and the multi-chamber bag according to claim 1.

18. The system according to claim 17, wherein the system comprises a monitoring device, which comprises an optical read apparatus for detecting the structure signalling the state of the separable seam and comprises an evaluation unit, the evaluation unit being configured such that a signal signalling the state of the separable seam is generated when the structure signalling the state of the separable seam is detected on the bag.

Description

[0033] Several embodiments of the invention will be explained in greater detail below with reference to the drawings, in which:

[0034] FIG. 1 is a simplified schematic plan view of an embodiment of the multi-chamber bag according to the invention,

[0035] FIG. 2 is a section through the bag from FIG. 1 in the region of the separable seam when the seam is closed,

[0036] FIG. 3 is a section through the bag from FIG. 1 in the region of the separable seam when the seam is open,

[0037] FIG. 4A-4D show different embodiments of graphical structures for signalling the state of the seam,

[0038] FIG. 5 shows other embodiments of graphical structures for signalling the state of the seam, which are designed as patterns,

[0039] FIG. 6A-6C show another embodiment of a graphical structure for signalling the state of the seam,

[0040] FIG. 7A-7C show another embodiment of a graphical structure for signalling the state of the seam,

[0041] FIG. 8A-8E show another embodiment of a graphical structure for signalling the state of the seam,

[0042] FIG. 9A-9E show an embodiment of a graphical structure designed as a machine-readable matrix code for signalling the state of the seam,

[0043] FIG. 10A-10D show an embodiment of a graphical structure designed as a machine-readable bar code for signalling the state of the seam,

[0044] FIG. 11 shows another embodiment of a structure for signalling the state of the seam, and

[0045] FIG. 12 is a highly simplified schematic view of a monitoring device for monitoring the state of the seam.

[0046] FIG. 1 is a plan view of a multi-chamber bag 1 for receiving liquids. The multi-chamber bag 1 comprises an upper film 2 and a lower film 3, which are interconnected at the edges 4 by a peripheral seam 5. The seam may be a welded seam, the films, in particular flexible films, being welded to one another. This seam is referred to as a non-separable seam in the following. The bag 1 may also be produced from a film sleeve that is closed by a non-separable seam at both the upper and the lower edge 6, 7.

[0047] The multi-chamber bag 1 comprises a first chamber 1A (compartment) and a second chamber 1B (compartment) (dual-chamber bag). The two chambers 1A, 1B are separated by a separable seam 8 (peel seam), which extends between the portions of the non-separable seam that run along the longitudinal sides of the bag.

[0048] The first chamber 1A is filled with a first liquid and the second chamber is filled with a second liquid, which are intended to be stored separately from one another and only mixed together shortly before use. In order to mix the two liquids together to form the ready-to-use solution, pressure is exerted on the bag such that the separable seam 8 is opened. The first liquid may for example be a component of a dialysate containing bicarbonate, and the second liquid may for example be a component of a dialysate containing calcium.

[0049] The multi-chamber bag 1 comprises a connector 9 (port) on the lower edge 7 of the bag, to which a hose line (not shown) can be connected in order to remove the liquid. The bag 1 can be hung on a suitable stand and the ready-to-use solution can be conveyed under the influence of gravity or using a pump. A multi-chamber bag of this type is part of the prior art.

[0050] FIG. 2 is a section through the multi-chamber bag 1 from FIG. 1 in the region of the separable seam 8. FIG. 2 shows the two films 2, 3, which are interconnected in a fluid-tight manner by means of the separable seam 8 in order to divide the bag volume into the first and the second chamber. The geometry of the bag is determined by the dimensions of the films and the quantity of the liquids contained in the two chambers. When the separable seam 8 is intact, the two films 2, 3 lie flat against one another in a particular spatial orientation in the region of the separable seam. When the separable seam has been torn open, however, the two films 2, 3 do not lie flat against one another in the region of the separable seam. FIG. 3 shows that the films 2, 3 are arranged at a distance from one another and are offset from one another or are misaligned relative to one another when the seam 8 is open.

[0051] The multi-chamber bag 1 according to the invention is characterised by a structure 10, which is visually perceptible to the user, for signalling the state of the separable seam 8, and is provided in the region of the separable seam 8. The structure 10 for signalling the state of the separable seam, which is shown in FIG. 1 by a shaded area, shows the user whether the separable seam is open or closed. The structure, which is perceptible to the viewer, can have various designs.

[0052] In the following, various embodiments of the structure for signalling the state of the separable seam are described in detail with reference to FIGS. 4 to 11.

[0053] FIG. 4A to 4D show different embodiments of the structure 10 for signalling the state of the separable seam, which is composed of individual structural elements 11 that are provided in a predetermined spatial arrangement relative to one another in the region of the separable seam 8 on the films 2, 3 that are arranged against one another. The structural elements 11 are image elements and/or symbol elements that are applied to the two films. The image elements and/or symbol elements 11 are preferably printed onto the films 2, 3. Known printing methods may be used for this purpose.

[0054] The structure 10 for signalling the state of the separable seam is only visible to the viewer when the two films 2, 3 of the bag 1 lie flat against one another in the predetermined orientation, i.e. the separable seam 8 is closed (FIG. 2). Otherwise, the viewer cannot identify the graphical structure 10, or at least can only identify it with difficulty (FIG. 3). The graphical structure 10 may be provided on the two films along the separable seam either over the entire length of the seam or only over part of the length of the seam. A plurality of different structures may also be provided along the seam.

[0055] FIG. 4A shows an embodiment of a graphical structure 10 which is designed as a preferably black area having a particular spatial extent, for example a rectangular or square area. This structure may repeat at predetermined intervals in the region of the separable seam. It may be exactly the width of the separable seam, or may also extend beyond said seam. It may, however, also be narrower than the separable seam.

[0056] The image elements and/or symbol elements 11 are lines or areas in this case. Lines which form a positive image of a logo of the applicant are applied to, preferably printed onto, the upper film 2 in the region of the separable seam 8. An area which corresponds to the region of the upper film 2 to which the lines are not applied is applied to, preferably printed onto, the lower film 3 in the region of the separable seam, i.e. the negative image of the logo is applied to the lower film. When the separable seam is closed, such that the films 2, 3 lie flat against one another in the predetermined spatial orientation (FIG. 2), only a black area 10 is apparent to the viewer. If the seam is open, however, the films 2, 3 are arranged at a distance from one another and/or offset from one another and/or misaligned relative to one another and are not in a precise spatial orientation relative to one another, and therefore the black area is no longer visible. The viewer can then identify the logo as a positive image or a negative image, depending on the side from which the viewer is looking at the bag. The black area may for example be ascribed the meaning whereby the separable seam is intact and therefore the two liquids are not yet mixed together, and the logo may be ascribed the meaning whereby the separable seam is open and therefore the two liquids have been mixed together to form the ready-to-use solution. Instead of black lines, coloured lines, for example red lines, may be applied to the transparent upper film 2, while the lower film 3 may be a transparent film to which a corresponding coloured area, for example a red area, can be applied.

[0057] If a continuous series of these structures is provided on the separable seam, the separable seam is apparent to the viewer as a black line. When the seam is open, a series of logos is apparent to the viewer. If the seam is only partially torn open, the logos are only apparent in the portion of the seam that is torn open, while the intact portion of the seam is apparent as a black line.

[0058] FIG. 4B shows another embodiment of a graphical structure 10 which is designed as a black area having a particular spatial extent, preferably a rectangular or square area. In this case, the image elements and/or symbol elements 11 of the graphical structure 10 are characters of a series of words that constitute the company name of the applicant. The individual characters are applied to, preferably printed onto, the upper film 2 in the region of the separable seam 8 in the form of black letters, for example. A for example black area, which corresponds to the region of the upper film to which the lines are not applied, is applied to, preferably printed onto, the lower film 3 in the region of the separable seam. When the separable seam is closed and the films 2, 3 lie flat against one another in the predetermined spatial orientation, only a black background is apparent to the viewer, i.e. the characters are not legible. If the separable seam is open, however, the upper or lower wording is apparent to the viewer. The black area may for example be ascribed the meaning whereby the seam 8 is intact, and the wording may be ascribed the meaning whereby the seam has been torn open.

[0059] Instead of a logo or instead of characters, the bag may however also be provided with a machine-readable code, such that the machine-readable code can be identified when the films do not lie against one another in the region of the separable seam, and cannot be identified when the films lie against one another in the region of the separable seam, i.e. only a black or grey area is visible.

[0060] FIG. 4C shows another embodiment of a graphical structure 10 which is composed of linear image elements and/or symbol elements 10 and constitutes a logo of the applicant. The upper and lower linear element 11 of the logo are applied to the upper film 2 in the region of the separable seam 8 and the central linear element 11 of the logo is applied to the lower film 3 in the region of the separable seam. When the seam is closed and the films 2, 3 lie flat against one another in the predetermined spatial orientation, the logo together with all the linear elements is apparent to the viewer, while the logo is not visible to the viewer when the seam is open, and therefore the spatial arrangement of the image elements and/or symbol elements 11 no longer exists. The logo may for example be ascribed the meaning whereby the seam is closed.

[0061] FIG. 4D shows another embodiment in which symbol elements 11 that form parts 11A, 11B of a series of words, for example the company name of the applicant, in the predetermined spatial arrangement are applied to the upper and the lower film 2, 3. A first part 11A of the company name is applied to the upper film 2 in the region of the separable seam 8 and a second part 11B of the company name is applied to the lower film 3 in the region of the separable seam 8. The first part 11A and the second part 11B complement one another to form the company name when the two films 2, 3 lie flat against one another and the separable seam 8 is closed. Otherwise, the viewer cannot identify the company name. The user can therefore assume that the separable seam 8 is still intact provided that the company name can be identified.

[0062] In the region of the separable seam 8, the image elements and/or symbol elements 11 may also form a first pattern on the upper film 2 and a second pattern on the lower film 3, which join together to form a third pattern when the films lie flat against one another. FIG. 5 shows different patterns as examples, with the first pattern being denoted by the reference sign I and the second pattern being denoted by the reference sign II.

[0063] FIG. 6A to 6C show an embodiment in which the image elements and/or symbol elements 11 of the graphical structure 10 are stripes that are applied to the upper and the lower film 2, 3 along the separable seam 8 and form a striped pattern. The stripes may be dark, preferably black, stripes, or may be stripes of any colour. The stripes are offset from one another on the two films 2, 3 along the separable seam such that the stripes are visible as a dark, preferably black or coloured, area when the films lie against one another, i.e. when the seam is closed (FIG. 6C). Otherwise, only the striped patterns are visible (FIGS. 6A and 6B).

[0064] FIG. 7A to 7C show an embodiment in which the structural elements 11 of the graphical structure 10 are transparent, coloured portions of the upper and the lower film 2, 3 in the region of the separable seam. The upper film 2 is for example a red transparent film portion in the region of the separable seam, while the lower film 3 is a green transparent film portion in the region of the separable seam, which is represented by the different shaded areas. The graphical structure 10 is apparent to the viewer as a yellow area (mixed colour made up of red and green) when the red and the green transparent film portion 2, 3 lie against one another and the separable seam 8 is closed.

[0065] FIG. 8A to 8E show a graphical structure 10 in which the image elements and/or symbol elements 11 along the separable seam are stripes (FIG. 8A) that are applied to the upper film 2 and stripes (FIG. 8B) that are applied to the lower film 3, which form a striped pattern. The stripes are black stripes which are offset from one another on the two films 2, 3 along the separable seam 8 such that said stripes are visible as a dark, preferably black, area 10 when the films lie against one another, i.e. when the seam is closed (FIG. 8C). FIGS. 8D and 8E show that a black area is not visible when the separable seam 8 is open and the films are at a distance from one another or are offset or misaligned relative to one another.

[0066] FIG. 9A to 9E show a graphical structure 10 in the form of a matrix code. The image elements and/or symbol elements 11 are square black areas that are applied, in the region of the separable seam 8, to the upper film 2 (FIG. 9A) and to the lower film 3 (FIG. 9B) such that the square black areas complement one another to form the matrix code when the separable seam is closed and the films 2, 3 lie against one another (FIG. 9C) and do not form the matrix code when the separable seam is open, meaning that the correct spatial arrangement of the square areas no longer exists (FIGS. 9D and 9E).

[0067] FIG. 10A to 10D show another embodiment, in which the graphical structure 10 is a bar code. The image elements and/or symbol elements 11 are black stripes that are applied, in the region of the separable seam 8, to the upper film 2 (FIG. 10A) and to the lower film 3 (FIG. 10B) such that the stripes complement one another to form the bar code when the separable seam is closed and the films 2, 3 lie against one another (FIG. 100) and do not form the bar code when the separable seam is open, meaning that the correct spatial arrangement of the stripes no longer exists (FIG. 10D).

[0068] FIG. 11A to 11D show an alternative embodiment in which the structure 10 for identifying the state of the separable seam 8 comprises portions of the upper and the lower film 2, 3 in the region of the separable seam 8 which have particular polarising properties. FIG. 11A shows the upper film 2 and FIG. 11B shows the lower film 3, the films being arranged at an angle of polarisation of 90° relative to one another when the separable seam is closed (FIG. 11C). The film portions function as polarisers that filter out visible light having a certain polarisation. The polarising films are arranged such that light cannot pass through the films, or can only pass through said films to a limited extent, when the films lie against one another in the predetermined orientation (FIG. 11C), i.e. the separable seam is closed, and light can pass through the films when they do not lie against one another in the predetermined orientation (FIG. 11D), i.e. the separable seam is open. The closed seam is then apparent to the viewer as a black or dark area, while the open seam is apparent as a light or grey area.

[0069] The bag 1 according to the invention makes it possible to monitor the fill level in an automated manner using a monitoring device. FIG. 12 is a highly simplified schematic view of a monitoring device 12 which comprises an optical read apparatus 13 and an evaluation unit 14. The evaluation unit 14 is configured such that a signal signalling the state of the separable seam is generated when the graphical structure 10 is detected on the bag 1. Known methods may be used for image recognition. The signal from the evaluation unit 14 may be received by a control unit 15A of a medical device 15 (merely indicated here), for example by a dialysis device, which is controlled by the control unit 15A on the basis of the signal.