Patent Application
20210196570
The invention relates to a multi-chamber bag for medical purposes which is formed by films, 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, the bag 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.
In this context, a separable seam is understood to be a seam that can be opened by a user as intended, while a non-separable seam is not intended to be opened by the user. The separable seam may for example be opened by applying a certain force, for example when pressure is exerted on the bag. The non-separable seam and the separable seam need to be designed such that the separable seam opens when the force required to open the separable seam is applied, while the non-separable seam remains intact. The separable seams are also referred to as peel seams.
Bags made of films are used in the medical field to receive liquids. To produce a film bag, an upper and a lower film having a peripheral seam can be joined together in a liquid-tight manner. Alternatively, the open ends of a film sleeve can be closed by seams. Irrespective of the production method, the bags thus have two pieces of film arranged against one another, which are referred to in the following as films. The two films generally consist of a material that is at least partially transparent to light. The films may each consist of a plurality of plies or layers.
The bags may for example receive medical solutions for infusion or dialysis. Bags of this type can be hung on a suitable stand such that the corresponding solution, for example dialysate, can flow out of an outlet that is arranged on the bottom edge of the bag in the position of use. A hose line can be connected to the outlet of the bag. The liquid can be conveyed under the influence of gravity or using a pump. Alternatively, or additionally, the bag may also be emptied using pressure, for example using hydraulic, pneumatic or mechanical pressure.
Multi-chamber bags are used in the medical field to receive various liquids that are only intended to be mixed together shortly before the intended use of the bag. They may for example contain two chambers (compartments) that are separated from one another in a liquid-tight manner by a separable seam. However, bags comprising more than two chambers are also known. The chambers may be filled with liquids and/or solid or pasty substances and/or gases, which are intended to be separated from one another during storage. Either all the chambers may be filled with one liquid each, or at least one chamber may be filled with a dry concentrate and at least one chamber with a liquid, the liquids being intended to be separated from one another during storage, or the at least one dry concentrate being intended to be separated from the at least one liquid, respectively.
One specific application is that of providing solutions that contain bicarbonate and calcium in physiological concentrations. Both components being in one solution can result in precipitates after a while, for example calcium carbonate. For this reason, the liquids are stored separately from one another in individual chambers. The separable seam between the chambers is only opened immediately prior to use, such that the liquids can be mixed together to form the ready-to-use solution having the physiological concentration. The liquids in the individual chambers do not, however, have the physiological concentration, and the use thereof can result in harm to the patient. Therefore, it is extremely important that the separable seam is actually opened.
It is also important that the seam remains closed until the solution is used, since the final solution would no longer be suitable for use if the two liquids were mixed together prematurely.
It is currently solely the user's responsibility to monitor the state of the separable seam, i.e. whether the seam is open or closed. However, since the bag films are at least partially transparent to light, in practice it is not readily apparent whether the separable seam is open or closed.
The problem addressed by the invention is to provide a multi-chamber bag for medical purposes that makes it possible to rapidly and reliably identify the state of a separable seam of the multi-chamber bag.
Another problem addressed by the invention is to provide a method by means of which the state of a separable seam of a multi-chamber bag for medical purposes can be rapidly and reliably identified.
These problems are solved according to the invention by the features of the independent claims. The dependent claims relate to advantageous embodiments of the invention.
The multi-chamber bag according to the invention is characterised by at least one visually perceptible structure that signals the state of the at least one separable seam and can be easily optically detected. Using this visible structure, the user can immediately identify whether the seam is open or closed, i.e. intact. The structure is composed of structural elements that the films, in particular flexible films, that are 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.
The films of the multi-chamber bag according to the invention are at least partially transparent to light, for example are see-through, transparent, partially transparent or translucent (opaque, diffusely transparent) to the viewer. According to the invention, the films may be transparent or translucent (opaque). In practice, the films are intended to be transparent, such that the user can assess the liquids contained therein on the basis of their visual appearance, and therefore impermissible precipitates, clouding, discolouration, etc. can be identified. At least partially transparent or largely transparent films are therefore particularly preferred.
The separable seam may be designed in any desired manner. Preferably, the seam is a welded seam, and so the two films are welded together.
When the films do not lie against one another in the region of the seam in a predetermined spatial arrangement, i.e. are arranged at a distance from one another or are misaligned relative to one another or are offset from one another, the predetermined spatial arrangement of the structural elements relative to one another no longer exists, and therefore the structure cannot be identified by the viewer or at least cannot be clearly identified by the viewer. When the seam is closed, however, the two films lie flat against one another, such that the films form a visual unit and the structure is apparent to the viewer.
A particular meaning may be ascribed to the visually perceptible structure, with it being possible for the user to understand the structure to be an indication of a closed seam.
The visually perceptible structure may be of any desired shape and extent. A plurality of structures which can be assigned to one seam or different seams may also be provided on the bag. The structural elements that compose the structure may be any desired elements. They may be image elements or symbol elements that can be applied to the films. The image elements or symbol elements may be circular, arc-shaped, elliptical, square or rectangular elements. They may also be dots or dashes, in particular parts of characters, or may also form patterns, for example a striped pattern.
The image elements and/or symbol elements are preferably printed onto the films. Known printing techniques may be used for this purpose. In this case, the outer faces of the films that face outwards may be printed. The structural elements may be transparent regions of the films that are a particular colour. They may also be incorporated into the film, for example the films may be dyed.
When the upper and lower film lie against one another, the image elements and/or symbol elements can show through the lower film when the viewer looks at the upper film from above, or vice versa.
The structural elements according to the invention are not the printed matter known from the prior art that is provided on the front and/or back of known liquid bags, for example manufacturer information, instructions for use, manufacturing date, use-by date, storage instructions, or hazard warnings, which is intended to be identifiable or readable by the user irrespective of the state of the separable seam, and which (i) are not designed such that they are incomplete or illegible when the two films do not lie against one another, and only join together to provide meaning when the two films lie against one another, and (ii) are not designed such that they are illegible when the two films lie against one another, and are only legible when the two films do not lie against one another.
By contrast, for printed matter according to the invention including instructions for use, it may be provided that the printed matter on the films for example makes the wording “Use within 4 hours” legible in the region of the peel seam once said peel seam has been opened, whereas the wording is illegible when the peel seam is closed owing to printed matter being on the rear film. Conversely, in another embodiment according to the invention, the printed matter could be designed such that, when the peel seam is closed, the wording “Open peel seam before use” is legible and becomes illegible after the peel seam has been opened.
One embodiment of the bag according to the invention provides that 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 the upper film which comprise the structural elements lie over regions of the 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. Therefore, the image elements and/or symbol elements are alternately arranged on the upper and the lower film. They therefore constitute parts of a unit. If the image elements and/or symbol elements for example form striped patterns, the unit of the parts is then apparent as a continuous area.
Another embodiment of the bag according to the invention provides that the structural elements are transparent regions of the films that are different colours, the 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 the lower film that is a second colour, which differs from the first colour. The structural elements, as the structure signalling the state of the separable seam, are then apparent to the viewer in a third colour, which is a mixed colour made up of the first and second colour, when the films lie against one another in the region of the separable seam.
The structural elements may also be designed as patterns, a structural element forming a first pattern being provided on the upper film in the region of the separable seam and a structural element forming a second pattern being provided on the lower film in the region of the separable seam, the first pattern differing from the second pattern such that the structural elements, as the structure signalling the state of the separable seam, are apparent to the viewer as a third pattern, which differs from the first and second patterns when the films lie against one another. The patterns may for example be repeating arrangements of dots or dashes or other image elements and/or symbol elements.
In a preferred embodiment, the structure signalling the state of the seam is a word or a series of words or a symbol, such that the viewer is given an immediately understandable indication of the state of the seam. For example, the structure may be the word “CLOSED”. In this embodiment, a first part of the word, for example the word “CLOSED”, or the series of words or the symbol is applied in a region on the upper film of the films arranged against one another, and a second part of the word or the series of words or the symbol is applied in a region of the lower film of the films arranged against one another that is below the region in which the first part is applied. When the seam is closed and the films lie against one another, the first and the second part complement one another to form the word, for example the word “CLOSED”, or the series of words or the symbol, such that the viewer can immediately identify the word.
The structure signalling the state of the seam may not only be identified by the user, but also by using a monitoring apparatus, which allows automated monitoring. The monitoring apparatus may comprise an optical read apparatus and an evaluation unit. The evaluation unit may be configured such that the visually perceptible structure is detected. To do this, the known algorithms for image recognition or image acquisition can be implemented in the evaluation unit.
The visually perceptible structure may also be a machine-readable code, for example a bar code or a matrix code, which can be read out easily using suitable read equipment. A machine-readable code in the form of a graphical structure has the advantage that the graphical structure not only allows the state of the separable seam to be monitored in an automated manner, but the structure can also be used as an information medium for other information, for example relating to the content of the bag and/or the use thereof. In this embodiment, 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.
It is also possible to combine the various embodiments, for example to combine coloured surfaces with characters or the like.
An alternative embodiment of the multi-chamber bag according to the invention for medical purposes provides that the at least one visually perceptible structure signalling the state of the separable seam 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. In this case, it is irrelevant how the polarising properties are imparted on the films, and this could be achieved by additional manufacturing steps during production, for example stretching or embossing. The films that lie against one another may also each consist of a plurality of plies or layers, with only one of the plies or layers having the polarising properties.
The two films that lie against one another in the region of the separable seam may have different angles of polarisation, for example. The films having the different polarising properties may for example be 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 spatial orientation, 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 spatial orientation, 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.
The method according to the invention for identifying the state of a separable seam of multi-chamber bags for medical purposes is characterised in that 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.
The bags are then monitored using a monitoring apparatus. The monitoring apparatus comprises an optical read apparatus for detecting the structure signalling the state of the seam, which structure may be a machine-readable code, and comprises an evaluation unit. In practice, each bag may be scanned using suitable read equipment. The evaluation unit is configured such that a signal signalling the state of the separable seam is generated when the structure signalling the state of the seam is detected on the bag. The signal may indicate an intact seam or an open seam. A plurality of different signals may also be generated. The signal may also be subject to further processing, in order to carry out an intervention in the control of a medical device, in particular a blood treatment device.
Several embodiments of the invention will be explained in greater detail below with reference to the drawings, in which:
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.
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.
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.
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
In the following, various embodiments of the structure for signalling the state of the separable seam are described in detail with reference to
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 (
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 (
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.
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.
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.
The bag 1 according to the invention makes it possible to monitor the fill level in an automated manner using a monitoring device.
| Number | Date | Country | Kind |
|---|---|---|---|
| 10 2018 116 787.3 | Jul 2018 | DE | national |
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/EP2019/068337 | 7/9/2019 | WO | 00 |
