WO2007038968A1

WO2007038968A1 - Medical packaging unit

Info

Publication number: WO2007038968A1
Application number: PCT/EP2005/010743
Authority: WO
Inventors: Olof Pahlberg; Thomas Barkmann; Manus O'donnell
Original assignee: Fresenius Kabi Deutschland Gmbh
Priority date: 2005-10-06
Filing date: 2005-10-06
Publication date: 2007-04-12

Abstract

The invention relates to a medical packaging unit with a first bag (1A) and a second bag (1B), which are connected to one another by a weakened zone (5) to form a single primary bag (1). Both bags have at least one chamber (7, 8, 9) for receiving different medical products, in particular medical solutions. With the preferred embodiment, the packaging unit according to the invention has a secondary bag (18), which accommodates the primary bag (1) together with an oxygen absorber (17).

Description

Medical packaging unit

The invention relates to a medical packaging unit for different medical products as well as a method for making available different medical products.

Packages of the most varied design are known for the accommodation of medical products. Medical liquids are made available for example in bags made of plastics material.

Bags for the accommodation of mixed medical solutions are known, said bags having at least two chambers in which the different solutions are contained. The two chambers are separated from one another by a separable seam, which is separated to produce the mixed solution, so that the two solutions can be mixed together to form the mixed solution.

If different medical products are to be made available separate from one another, the medical products are prepared separate from one another in different packages. In medical technology, there are various areas of application in which different medical products are used for a medical procedure. The products required for the procedure are then prepared in a so-called kit which contains the different products. However, each product of the kit is itself packaged in a separate packaging, these being handled separate from one another.

In organ transplantation, for example, kits are used which contain two fluids, whereof one fluid is a rinsing solution, with which an apparatus for receiving the transplant is rinsed, and the other fluid is a solution with which the apparatus is filled after rinsing for the purpose of preserving the transplant. The two solutions of the kit are connected in practical terms, but are used at different times, i.e. one after the other. The solutions are therefore prepared separate from one another in separate packages.

EP 0 700 280 Bl, for example, discloses a multi-chamber bag for the preparation of mixed solutions. A multi-layer film for the production of a multi-chamber bag is known for example from EP 0 739 713 Bl. DE 103 13 760 B3, for example, describes connectors for bags for injecting or removing solutions.

The problem underlying the invention is to make available a medical packaging unit, with which the handling of bags containing medical products, which each have at least one chamber for receiving a medical product, is improved. The solution to this problem takes place according to the invention with the features of claim 1.

Moreover, a problem of the invention is to specify a method with which the preparation of different medical products in a packaging unit can be simplified, said packaging unit comprising two bags, each of which has at least one chamber for receiving a medical product. The solution to this problem takes place according to the invention with the features of claim 13.

With the medical packaging unit according to the invention, the first and second bag, which each have at least one chamber for receiving a medical product, are connected by a weakened zone running between the at least one chamber of the one bag and the at least one chamber of the other bag to form a single primary bag, in such a way that the one bag is separable from the other bag.

The connection of the two bags to form a primary bag has decisive advantages both for the production as well as the use of the packaging unit. On the one hand, separate processes for the production of different bags are not required, since the single primary bag can be produced in only one work operation. The one bag can be separated from the other bag just before use of the medical products, in order that the medical products can be used in different places at different times. In principle, however, it is also possible to use the bags in the same place at the same time. In this case, the emptying of the bags is simpler than when both bags are joined together.

The weakened zone connecting the two bags together to form a single primary bag can be designed in different ways. Weakened zone is understood to mean all regions that weaken the unity of the bags, so that the bags can easily be separated from one another at a defined point or in a defined region, which lies between the at least one chamber of the one bag and the at least one chamber of the other bag.

Weakened zones as such belong to the prior art. For example, the strength of the material from which the primary bag is made can be reduced in the region of the weakened zone. It is also possible in the region of the weakened zone to make use of materials which have a much lower strength than the materials from which the rest of the primary bag is made. In order to create a weakened zone, moreover, perforations can be provided or rip bands can be laid into the material from which the primary bag is made.

Even though mention is made of a first and a second bag with the medical packaging unit according to the invention, the packaging unit can also have further bags, which have at least one chamber for receiving a medical product. Once again, these bags can also be connected by weakened zones to the other bags to form a single primary bag.

In a preferred embodiment of the medical packaging unit, the weakened zone is designed as a tear seam, so that the first bag can easily be torn away by hand from the second bag. The tearing-open of the tear seam is advantageously simplified by the fact that the weakened zone is notched at one end. The weakened zone can however also be notched at both ends.

In the case where the durability of the medical products, in particular medical fluids, is reduced if the fluids are exposed to oxygen, a further preferred embodiment of the packaging unit provides for a secondary bag, in which the first and second bags are disposed. Apart from the primary bag, an oxygen absorber is preferably disposed in the secondary bag. Since only one secondary bag is required for the two bags forming the primary bag, the packaging of the two bags can take place in just one work operation.

One or both bags forming the primary bag can be designed as multi-chamber bags, which each comprise at least two chambers. The individual chambers of the bags are separated from one another in this preferred embodiment, in such a way that a connection between the chambers can be produced. The chambers of the bags can be separated from one another by means of the known break-off parts or the known separable seams. A separable seam has proved to be particularly advantageous that has two essentially rectilinear, preferably parallel, segments, which are separated by a tear-open zone which has a curved, preferably circular, course. This separable seam on the one hand has sufficient strength to prevent unintentional opening and on the other hand has the property that the seam can be opened by hand without considerable expenditure of force.

The individual chambers of the primary bag can, depending on the case of application, have different connections for the supply and/or removal of the product.

An example of embodiment of the packaging unit according to the invention is explained below in greater detail by reference to the drawings.

In the figures:

Figure 1 shows a simplified diagrammatic representation of a primary bag of the packaging unit according to the invention in plan view and

Figure 2 shows a simplified representation of a packaging unit according to the invention, which comprises a primary bag and a secondary bag.

The medical packaging unit according to the invention has two bags IA and IB which are otherwise made available separately, said bags being joined to form a single primary bag 1. Figure 1 shows a simplified diagrammatic representation of primary bag 1 of the packaging unit according to the invention in plan view. Primary bag 1, which has a rectangular cut shape, is produced from a tubular film 2, whose upper and lower layer are welded together at their upper end 3 and at their lower end 4. The primary bag can however also be produced from two pieces of film lying one upon the other, which are welded together along their periphery.

A weakened zone 5 running from upper to lower weld edge 3, 4 divides the primary bag into two parts, whereby one part forms first bag IA and other part IB the second bag. First bag IA occupies roughly a third of the total volume of primary bag 1, whilst second bag IB encloses roughly two-thirds of the bag volume.

The weakened zone is a seam running rectilinearly, along which the film from which the primary bag is made is weakened. A small notch 6 is provided at the upper end of weakened zone 5.

The bag halves are torn apart in order to separate the two bag halves IA and IB, so that the weakened zone tears open. The tear advances, proceeding from notch 6, over the whole length of weakened zone 5 until the bag halves are completely separated from one another.

First bag half IA has a chamber 7 for receiving a medical solution, whilst second bag half IB has two chambers 8, 9 for receiving medical solutions. Different medical solutions are contained in all chambers 7, 8 and 9. The two chambers 8, 9 of second bag half IB are separated from one another by a separable seam 10, so that the different solutions contained in chambers 8, 9 are made available separated from one another. Separable seam 10 is separated only shortly before use, so that both solutions are mixed together to produce a mixed solution.

The medical solutions that are used in organ transplantations, for example, can be contained in primary bag 1.

Apparatuses for receiving transplants are known for example from US 2004/0171138 and US 6 100 082, said apparatuses being rinsed with a rinsing solution prior to insertion of the transplant and being rinsed thoroughly with a preservation solution after insertion of the transplant. The rinsing solution must first be made available. The preservation solution is then supplied, which is prepared in turn by mixing from two different solutions. If the packaging unit according to the invention is used for this preferred case of application, chamber 7 is filled with the rinsing solution and chambers 8 and 9 are filled with the solutions for preparing the preservation solution.

Separable seam 10 is described below in detail, said seam separating the two chambers 8, 9 of second bag half IB from one another. Separable seam 10 has a first rectilinear segment 11 which, proceeding from upper weld seam 3 in the middle between weakened zone 5 and the outer edge of primary bag 1, runs over approximately two-thirds the length of the bag. Moreover, separable seam 10 has a second segment 12 disposed laterally offset with respect to first segment 11, said second segment running parallel to weakened zone 6 up to lower weld seam 4 of primary bag 1. The ends of the two segments are connected together via a semicircular tear-open zone 13, the radius whereof preferably lies between 15 and 25 mm. The separable seam can be produced according to the method described in EP 0 700 280 Bl, whereby the shape described above is to be provided.

To produce the mixed solution, bag half IB separated from bag half IA is rolled up from top to bottom, as a result of which seam 10 first tears open in the region of tear-open zone 13. The tear line advances, proceeding from tear-open zone 13 on both sides along rectilinear segments 11, 12 of the seam, until the whole seam is separated, so that the two solutions can mix with one another.

Chambers 7, 8 and 9 each have a connector 15, 16 for the injection and/or removal of fluids. Connectors 14 and 16 are used for the removal of fluid, whilst connector 15 permits the injection of fluid. The connectors are described in detail in DE 103 13 760 B3.

Primary bag 1 is produced from a heat-sterilisable multi-layer film, which has an external layer, a support layer and a middle layer disposed between the latter. The film described in detail in EP 0 228 819 or EP 0 739 713 can be used as the multilayer film. Figure 2 shows the whole packaging unit according to the invention, which also comprises a secondary bag 18 as well as primary bag 1. The secondary bag is produced from a multi-layer film with an oxygen barrier. It also has a rectangular cross-section and accommodates primary bag 1 together with an oxygen absorber 17 in an airtight manner.

Prior to the use of the medical solution, secondary bag 18 is first torn open so that primary bag 1 can be removed. Primary bag 1 is then separated along weakened zone 5 into two bag halves IA and IB, which can be made available at different times in different places. Seam 10 of second bag half IB can then be separated later to produce the mixed solution.

Claims

Patent Claims:

1. A medical packaging unit with

a first bag (IA), which has at least one chamber (7) for receiving a medical product, and

a second bag (IB), which has at least one chamber (8, 9) for receiving a medical product,

characterised in that the packaging unit has a weakened zone (5) running between the at least one chamber (7) of the first bag (IA) and the at least one chamber (8, 9) of the second bag (IB), whereby the weakened zone (5) connects the first and second bag to form a single primary bag (1) in such a way that the first bag is separable from the second bag.

2. The medical packaging unit according to claim 1, characterised in that the weakened zone (5) is designed as a tear seam, so that the first bag (IA) can be torn off from the second bag (IB).

3. The medical packaging unit according to claim 1 or 2, characterised in that the weakened zone (5) has a notch (6) at one end.

4. The medical packaging unit according to any one of claims 1 to 3, characterised in that the packaging unit has a secondary bag (18) in which the primary bag (1) is disposed.

5. The medical packaging unit according to claim 4, characterised in that, apart from the primary bag (1), an oxygen absorber (17) is disposed in the secondary bag (18).

6. The medical packaging unit according to any one of claims 1 to 5, characterised in that the first and/or second bag (IA, IB) has at least two chambers (8, 9) which are separated from one another in such a way that a connection between the chambers can be produced.

7. The medical packaging unit according to claim 6, characterised in that the at least two chambers (8, 9) of the first and/or second bag (IA, IB) are separated from one another with a separable seam (10).

8. The medical packaging unit according to claim 7, characterised in that the separable seam (10) has two essentially rectilinear, preferably parallel, segments (11, 12) which are separated by a tear-open zone (13), which has a curved course, preferably a course shaped as a segment of a circle.

9. The medical packaging unit according to any one of claims 1 to 8, characterised in that the chamber(s) of the first and/or second bag (IA, IB) have a coupling (14, 15, 16) for the supply and/or removal of the product.

10. The medical packaging unit according to any one of claims 1 to 9, characterised in that the chamber(s) of the first and/or second bag (IA, IB) are filled with a medical solution.

11. The medical packaging unit according to any one of claims 1 to 10, characterised in that the primary bag (1) and/or secondary bag (18) is made from a multi-layer film.

12. The medical packaging unit according to claim 11, characterised in that the multi-layer film of the secondary bag (18) has an oxygen barrier.

13. A method for making available different medical products with the following process steps:

making available a packaging unit with a first bag (IA), which has at least one chamber (7) for receiving a medical product, and a second bag (IB), which has at least one chamber (8, 9) for receiving a medical product, whereby the first and second bags (IA, IB) are connected to one another by a weakened zone (5) running between the at least one chamber of the first bag and the at least one chamber of the second bag to form a single primary bag (1), in such a way that the first bag is separable from the second bag,

filling the at least one chamber (7) of the first bag (IA) and the at least one chamber (8, 9) of the second bag (IB) with different medical products,

separating the first bag (IA) from the second bag (IB), and

removing the medical product from the first and/or second bag (IA, IB).

14. The method according to claim 13, characterised in that, after the filling of the chambers (7, 8, 9), the primary bag (1) is disposed in a secondary bag (18).