EP2167011B1 - Multi-chamber bag for use with enteral nutrition - Google Patents

Description

The invention relates to a multi-compartment bag for use in enteral nutrition containing an enteric nutrient solution.

In medicine, a distinction is made between an enteral and a parenteral nutrition. Parenteral nutrition differs from enteral nutrition in that it bypasses the gastrointestinal tract. Therefore, in principle, enteral and parenteral nutrient solutions differ in composition.

The enteral nutrient solutions must be suitable for covering the energy and nutrient content. They generally contain proteins, carbohydrates, fats, vitamins and minerals. Enteral nutrient solutions may also contain fiber.

The industrially produced enteral nutrient solutions are provided as tube feed in rigid or flexible containers. As containers serve bottles or bags. The containers have a connection piece for connecting a transfer system, with which the enteral nutrient solution is transferred from the container into the stomach of the patient. The transfer of the nutrient solution can be carried out by gravity or by means of a pump.

The known transfer systems have a hose line which has at one end a connector for connection to the connection piece of the nutrient solution container and at the other end a connector for connection to the connection piece of a probe tube. In promoting the nutrient solution by means of a pump, a hose line section is designed as a pump segment, which is inserted into a roller pump.

While in enteral nutrition all nutritional components can be provided in a single solution, in parenteral nutrition the food components, especially protein sources, carbohydrates and fats, must be stored separately for stability.

The EP 0 790 051 B1 describes a bag for use in parenteral nutrition, which contains a plurality of separate chambers for separately storing the individual food components. Shortly before the administration of the parenteral nutrient solution, a fluid connection is established between the individual chambers, so that the different components can mix with one another.

For the preparation of the liquid connection serve as break-off parts formed connecting pieces, which are welded in the welds of the bag. Alternatively, the welds may also be formed as separable or tearable seams. These seams are also called peel seams.

Multi-compartment bags for use in parenteral nutrition are also available from the EP 0 619 998 B1 . EP 0 893 982 B1 . WO 2007016615 A1 . WO 2005089697 A1 and EP 0 883 396 B1 known.

As storage problems for enteral nutritive solutions generally do not pose stability problems due to the mixture of components, which include protein sources, carbohydrates and fats, there are no known receptacle containers for use in enteral nutrition, which have several compartments for the intake of the components of the enteral Nutrient solution.

The industrially produced enteral nutrient solutions alone can not cover the fluid requirement of the patient. Therefore, it is necessary to administer the patient next to the enteral nutrient solution nor a liquid. This liquid can have a lower energy content. In the simplest case, water is administered to the patient in addition to the enteral nutrient solution, which has no nutritional value.

For administering liquids to cover the fluid requirement, separate containers are used in the prior art, which are also referred to as hydrobags.

From the EP 1 795 169 A1 a container is known, which is divided by a partition into two equal chambers. For emptying the chambers is a common outlet opening, which is in communication with both chambers. At the outlet opening a shut-off or mixing device is connected, with which the liquids contained in the chambers can be removed in the desired dosage or in succession. One chamber is intended to contain an enteral nutrient solution and the other chamber a tea or water. The two chambers should be refilled with enteral nutrient solution or tea or water. Therefore, the chambers each have a filling opening, which can be closed with a lid. The enteric nutrient solution, which is packed in tubular bags made of aluminum composite foil protected from light and oxygen, should only be transferred to the container immediately before administration.

The registration WO 2007/016615 concerns medical devices and parenteral formulations. It describes the separate storage of the individual components of the parenteral formulations, more specifically, the amino acid component, the fat component and the carbohydrate component, in single chambers of a multi-compartment bag. The individual components of the parenteral formulations may be mixed together prior to administration by dissolving soluble sutures between the individual components.

WO 2005/089697 concerns an enteral feeding bag. The bag contains a chamber containing the enteral nutrient solution.

EP 1894 851 A1 concerns a two-chamber bag. The pouch is said to be suitable for storage of nutrient solutions such as amino acid formulations, sugar formulations, protein and amino acid formulations. The individual components of the formulations may be mixed together prior to administration by dissolving detachable sutures between the individual components.

BE 894727 A concerns a package for the separate storage of two products.

The registration WO 97/37628 relates to containers for parenteral formulations. It describes the separate storage of the individual components of the parenteral formulations, more specifically, the amino acid component, the fat component and the carbohydrate component, in single chambers of a multi-compartment bag. The individual components of the parenteral formulations may be mixed together prior to administration by dissolving soluble sutures between the individual components.

WO 97/05852 relates to a bag containing a sterile solution, such. B. a dialysis solution or a nutrient solution. In this case, the bag can be a first chamber with z. B. an electrolyte solution and a second and a third chamber each with a glucose solution.

The invention is based on the object to simplify an enteral nutrition, with a sufficient hydration.

This object is achieved with the features of claim 1. Advantageous embodiments of the invention are the subject of the dependent claims.

The container according to the invention for use in enteral nutrition is characterized in that the container is a multi-chamber bag with at least two separate chambers, wherein at least one chamber contains an enteral nutrient solution with a first energy content and at least one chamber with a liquid to cover the fluid requirement contains an energy content that is smaller than the energy content of the enteral nutrient solution. Since with the multi-chamber bag according to the invention both the enteral nutritive solution and the liquid still required to cover the fluid requirement are provided directly, the use in enteral nutrition is simplified. A transfer of liquids from other containers is not required. Both liquids are put together in provided a bag that can easily collapse when emptying and can be produced inexpensively. Since the bag can collapse, aeration of the bag is basically not required. Therefore, there is no increased risk of contamination.

A decisive advantage of the multi-chamber bag according to the invention is to provide both the enteric nutrient solution and the liquid to meet the fluid requirement so that the individual requirements of the patient with regard to the composition and amount of the two fluids can be taken into account.

For example, either only the enteric nutrient solution from the one chamber can be administered to the patient, or both the enteral nutrient solution and the liquid can be administered to cover the fluid requirement. Both liquids are ready in the multi-chamber bag. If the multi-compartment bag has more than two chambers, different amounts of fluids can be provided, which can be administered depending on the individual needs of the patient. For example, several chambers for enteral nutrient solutions and / or several chambers for liquids may be provided to cover the fluid requirements, which have different volumes and absorb different amounts of fluid. Depending on the individual needs of the patient then only some or all of the chambers are emptied.

The enteral nutritive solution has an energy content of at least 0.5 kcal / ml, preferably of at least 0.8 kcal / ml, more preferably of at least 1 kcal / ml, to meet the energy requirement of the patient. It contains a source of protein, carbohydrates and fats. Milk and soya proteins can be used as protein sources. As carbohydrates poly- and oligosaccharides can be used. Soya, sunflower oils, coconut and milk fats and fish oil, MCT (medium chain triglycerides), palm kernel oil, rapeseed oil and structured triglycerides may be considered as sources of fat. The enteral nutrient solution It is also possible to add vitamins, trace elements and electrolytes as well as roughage.

The liquid to cover the fluid requirement differs from the enteral nutrient solution essentially by the lower energy content. In the simplest case, the fluid requirement is covered by water.

The at least one chamber, which is filled with the enteral nutrient solution, preferably has a larger volume than the at least one chamber which is filled with the liquid to cover the fluid requirement. Preferably, one compartment contains from 750 to 1500 ml enteral nutrient solution while the other compartment contains from 250 to 750 ml of fluid.

According to the invention, the multi-chamber bag has means for producing a fluid connection between the individual chambers containing enteral nutrient solution or fluid to cover the fluid requirement. In this embodiment, a single fitting suffices both for withdrawing the enteral nutrient solution and the liquid for covering the fluid requirement. After administration of the enteral nutrient solution, the fluid connection between the chambers can be established and the liquid can be administered instead of the already administered nutrient solution to cover the fluid requirement. Both liquids can basically be mixed in advance.

The administration of the nutrient solution or the liquid to cover the fluid requirement may be due to gravity or by means of a metering pump. For this purpose, the multi-chamber bag preferably has a hanger to which the container can be hung on a stand or the like. This hanger is arranged on the opposite side of the multi-chamber bag for removing the liquids.

An alternative embodiment provides that not only the at least one chamber, which is filled with the enteral nutrient solution, but also the at least one chamber, which is filled with the solution for covering the fluid requirement, having a connector for removing liquid. In this embodiment, each chamber may be drained via the respective fitting, with no need to establish fluid communication between the chambers.

In the alternative embodiment, the multi-chamber bag preferably also has a hanger on the opposite side of the connector for removing the liquid to cover the fluid requirement. To remove the enteral nutrient solution or the liquid to cover the fluid requirement of the multi-chamber bag needs only to be reversed and hung on the respective hanger.

Another particularly preferred embodiment provides that the multi-chamber bag is provided together with a device for transferring the enteral nutrient solution and / or the liquid to cover the fluid requirement to the patient. The multi-chamber bag and the transfer system are preferably sterile packed in a package. As transfer systems, it is possible to use all known transfer devices which have a hose line which at one end has a connection piece for the multi-chamber bag and at the other end a connector for an enteral feeding tube. Preferably, the packaging enclosing the multi-chamber bag and the transfer system is again a bag.

The multi-chamber bag can be made from the materials known to those skilled in the art according to known methods.

In the multi-chamber bag, the means for establishing a fluid connection between the chambers are formed as separable seams, so-called peel seams.

In the following, various embodiments of the invention will be explained in more detail with reference to the drawings.

Fig. 1

Eine vereinfachte schematische Darstellung eines ersten Ausfühmngsbeispiels eines nicht erfindungsgemäßen Mehrkammerbeutels zur Verwendung in der enteralen Ernährung, das über zwei Kammern verfügt,

Fig. 2

ein Ausführungsbeispiel des erfindungsgemäßen Mehrkammerbeutels in schematischer Darstellung, das über zwei Kammern verfügt,

Fig. 3

ein weiteres Ausführungsbeispiel des Mehrkammerbeutels, das über drei Kammern verfügt,

Fig. 4

ein alternatives Ausführungsbeispiel des Mehrkammerbeutels mit drei Kammern und

Fig. 5

eine Anordnung in vereinfachter schematischer Darstellung, die einen Mehrkammerbeutel zusammen mit einem Überleitsystem umfasst, wobei der Mehrkammerbeutel und das Überleitsystem von einer Verpackung umschlossen werden.

Show it:

Fig. 1

A simplified schematic representation of a first embodiment of a non-inventive multi-chamber bag for use in enteral nutrition, which has two chambers,

Fig. 2

an embodiment of the multi-chamber bag according to the invention in a schematic representation, which has two chambers,

Fig. 3

Another embodiment of the multi-chamber bag, which has three chambers,

Fig. 4

an alternative embodiment of the multi-chamber bag with three chambers and

Fig. 5

an arrangement in a simplified schematic representation, which comprises a multi-chamber bag together with a transfer system, wherein the multi-chamber bag and the transfer system are enclosed by a package.

Fig. 1 shows a simplified schematic representation of an embodiment of a non-inventive multi-chamber bag for use in enteral nutrition. The multi-chamber bag is a polymeric bag in the present embodiment.

The bag 1 consists in the present embodiment of two superposed flexible plastic films 2, 3, which are welded at their edges with a circumferential weld 4, which in the in Fig. 1 shown location a lower one Section 4A and an upper portion 4B and two lateral portions 4C and 4D. The bag may also consist of a film tube, which is welded at the top and bottom.

The bag is divided into a lower chamber 5 and an upper chamber 6. The lower chamber 5 has a larger volume than the upper chamber 6. For example, the lower chamber can accommodate 1500 ml of liquid while the upper chamber can hold 500 ml of liquid. Both chambers 5, 6 are separated from each other by a non-separable weld 7, which runs in the upper third of the bag between the lateral sections 4C, 4D of the circumferential weld 4.

The bag 1 has two connecting pieces 8A and 8B, of which one connecting piece 8A is welded into the lower portion 4A of the circumferential weld 4 and the other connecting piece 8B is welded into the upper portion 4B of the circumferential weld 4.

To the fittings 8A and 8B, a transfer system can be connected, with reference to Fig. 5 will be described in detail. A connector for connecting a transfer system to a bag for receiving enteral nutrient solution is for example from EP 1010 412 A2 or the EP 0 830 874 B 1 which is expressly referred to for the purpose of disclosure. Such a connector is also referred to as a port.

The connecting pieces 8A and 8B each have a pierceable membrane 8A 'and 8B', which is shown only hinted. The pierceable membranes seal the two chambers 5, 6 sterile.

In the region of the lower portion 4A of the circumferential seam 4, the bag has a lower hanger 9A and in the region of the upper portion 4B of the peripheral weld 4, an upper hanger 9B. Both hangers 9A, 9B are formed as tabs formed on the lower and upper portions of the bag. When Hanger can also serve as recesses in the upper and lower portions of the bag or its welds.

The lower chamber 5 with the larger volume is filled with an enteral nutrient solution A containing various components, which include a source of protein, carbohydrates and fats. The enteric nutrient solution A alone can not cover the fluid requirement of the patient. For fluid balance, therefore, the patient requires another fluid B contained in the upper chamber 6. This liquid is in the present embodiment, water (H ₂ O).

The enteral nutritive solution A differs from the fluid B for covering the fluid requirements of the patient in that the enteral nutritive solution has a substantially higher energy content than the fluid B for covering the fluid requirement. The enteral nutritive solution has an energy content of at least 0.5 kcal / ml, preferably of at least 0.8 kcal / ml, more preferably of at least 1 kcal / ml, while the liquid has an energy content of less than 0 to cover the fluid requirement. 5 kcal / ml, preferably water which has no energy content.

For administration of the enteral nutrient solution A or the fluid B for fluid balancing, a transfer system 10 is used, which is described below with reference to FIG Fig. 5 is described.

Fig. 5 shows an assembly comprising the bag 1 and the transfer system 10, wherein the bag and the transfer system are packaged in a package 20 sterile. The package 20 is in turn a bag of superimposed films 12, 13, which are welded together with a circumferential weld 14. The bag 20 may also consist of a film tube which is welded at the top and bottom. At least part of the circumferential weld 14 is formed as a separable or tearable weld (peel seam). Therefore, it is possible to simply rupture the package 20 to remove the bag 1 and the transfer system 10.

The transfer system 10 has a hose 11, wherein at the one end of the hose 11, a connector 16 for connecting the transfer system to one of the two connectors 8A, 8B of the bag 1 is provided and at the other end of the hose a connector 23 for connecting the Transfer system is connected to a corresponding connector of a probe tube, not shown, for enteral nutrition. The promotion of liquids can be done by gravity alone. But it can also be used a metering pump. In the known metering pumps are peristaltic peristaltic pumps, in which a hose line section 11A of the hose 11 is inserted.

In the hose 11 is a drip chamber 18 and a hose clamp 19. Before use, the hose is sealed with a closure member 15. The closure part 15 contains a break-off part 15A, which is broken off to open the hose, so that a fluid connection is made.

In the package 20, the connector 16 of the transfer system is already connected to the lower connector 8A of the bag 1. The transfer system can also be attached to the bag only. The connector 16 of the transfer system has a spike 16A, with which the membrane 8A 'or 8B' of the connecting pieces 8A or 8B can be pierced, so that a fluid connection to the two chambers 5, 6 of the bag 1 can be produced.

With the system, an enteral nutrition and fluid balance can be done easily. For this purpose, the enteral nutrient solution A is supplied from the lower chamber 5 under the influence of gravity or by means of a metering pump via the tubing 11 of the transfer system 10 and the probe tube, not shown, to the patient. At this time, the bag is hung on the upper hanger 9B. To cover the fluid requirement, the bag is turned over and suspended on the lower hanger 9A, wherein the connector 16 of the transfer system 10 is connected to the then lower connector 8B, so that the then filled with water B chamber 6 emptied.

Both chambers can be emptied at different times without a connection between the chambers. If the administration of additional fluid is not required, the chamber filled with water need not be emptied.

The filled with enteral nutrient solution A chamber 5 in principle has a larger volume than the filled with water B chamber 6. It is also possible to fill the larger chamber with water and the smaller chamber with enteral nutrient solution.

Fig. 2 shows an embodiment of the two-chamber bag according to the invention. The two-chamber bag 16 of Fig. 2 differs from the bag 1 of Fig. 1 in that the weld seam 7 separating both chambers 5, 6 is not a permanent seam but is formed at least in one section as a manually separable or tearable peel seam 7 '. In addition, the bag 12 has only in the in Fig. 2 shown position lower connector 8A and the upper hanger 9B, but not an upper connector and a lower hanger on. Otherwise, the bags 1 and 16 do not differ from each other. Therefore, the same reference numerals are used for the corresponding parts.

For application of the enteral nutrient solution, the bag 12 is suspended from the hanger 9B, so that under the influence of gravity or by means of a metering pump, the enteral nutrient solution A can be conveyed out of the chamber 5. To administer the liquid B to cover the fluid requirement, the peel seam 7 'is separated by hand, so that the liquid B, for example water, can be administered to the patient. In this embodiment, it is not necessary to turn the bag over and reconnect the connector of the transfer system.

Fig. 3 shows a further embodiment, which differs from those with reference to the Figures 1 and 2 described embodiments differs in that the bag 17 has three chambers. The corresponding parts are again provided with the same reference numerals.

The embodiment of Fig. 3 differs from the embodiment of Fig. 1 by a further peel seam 7 ", which runs from the permanent seam 7 to the lateral section 4C of the circumferential weld seam 4. The permanent weld seam 7 and the peel seam 7" divide the bag 17 into three chambers 5, 6 and 21. The larger chamber 5 is filled with 1000 ml of enteral nutrient solution A and the smaller chamber 21 with 500 ml of enteral nutrient solution A ', while the smaller chamber 6 is filled with 500 ml of liquid B to cover the fluid requirements, especially water.

The three-chamber bag 17 of Fig. 3 allows a more accurate dosage of the food or liquid needs of the patient than the two-chamber bag 1, 16 of Fig. 1 and Fig. 2 , Depending on the needs of the patient, either only the enteral nutrient solution A contained in the chamber 5 or both the nutrient solutions A and A 'contained in the chamber 5 and in the chamber 21 can be administered. For this purpose, it is only necessary to separate by hand the peel seam 7 "In addition, after the bag has been turned over and the transfer system has been connected to the other connecting piece, the liquid B, in particular water, can be administered to cover the fluid requirement.

Fig. 4 shows a further embodiment of the bag 22, which differs from the embodiment of Fig. 3 only differs in that the smaller chamber 21 is not einghalts with enteral nutrient solution, but with a liquid B 'to cover the fluid requirements, especially water. The bag 22 thus allows application of different amounts of water.

In the FIG. 3 and FIG. 4 shown bags 17 and 22 each have two connectors and two hangers.

For the purposes of the present invention, the bags have FIG. 3 and FIG. 4 but only a connector and a trailer and the permanent seam 7 is formed as separable peel seam. But it is also possible to form the peel seam 7 "as a permanent seam, the bag then has a further connector and another trailer.

Although the present embodiments show only two-chamber and three-chamber bags, the bag according to the invention may also comprise further chambers, which are separated by permanent sutures or peel sutures and filled with either an enteral nutrient solution or a liquid for fluid balance of the patient, so that a particularly accurate Adjustment of the food or fluid requirements to the individual needs of the patient is possible. It is also possible that the chamber or chambers containing enteric nutrient solution contain enteral nutrient solutions with different compositions. Furthermore, it is possible for the chamber or chambers containing liquid to cover the fluid requirement to contain different fluids for fluid balance, for example water and, for example, fruit juice on the one hand. But here, too, it is assumed that the energy content of the liquids for fluid balance is smaller than the energy content of the enteral nutrient solutions.

Claims (14)

1. A multi-chamber bag for use with enteral nutrition, which contains an enteral nutrient solution, wherein the multi-chamber bag (1, 16, 17, 22) exhibits at least two chambers (5, 6) which are separated from one another, wherein at least a first chamber (5) of the at least two chambers contains an enteral nutrient solution (A) with a first energy content and at least a second chamber (6) of the at least two chambers contains a fluid (B) for covering the fluid requirement with an energy content that is lower than the energy content of the enteral nutrient solution and wherein the at least one chamber (5), which is filled with the enteral nutrient solution (A), is separated from the at least one chamber (6), which is filled with fluid for covering the fluid requirement, by a separable seam (7'), characterized in that the enteral nutrient solution (A) contains a source of protein, carbohydrates and fats.
2. The multi-chamber bag according to claim 1, characterized in that the enteral nutrient solution (A) has an energy content of at least 0.5 kcal/ml, preferably of at least 0.8 kcal/ml, particularly preferably of at least 1 kcal/ml.
3. The multi-chamber bag according to claim 1 or 2, characterized in that the fluid for covering the fluid requirement has an energy content which is less than 0.5 kcal/ml.
4. The multi-chamber bag according to claim 3, characterized in that the fluid (B) for covering the fluid requirement is water.
5. The multi-chamber bag according to one cf the claims 1 to 4, characterized in that the volume of the at least one chamber (5), which is filled with enteral nutrient solution (A), is greater than the volume of the at least one chamber (6), which is filled with the fluid (B) for covering the fluid requirement.
6. The multi-chamber bag according to one of the claims 1 to 5, characterized in that the at least one chamber (5), which is filled with enteral nutrient solution (A), contains 750 to 1500 ml enteral nutrient solution and the at least one chamber (6), which is filled with fluid (B) for covering the fluid requirement, contains 250 to 750 ml solution for covering the fluid requirement.
7. The multi-chamber bag according to one of the claims 1 to 6, characterized in that means (7', 7") are provided for producing a fluid connection between the at least one chamber (5), which is filled with the enteral nutrient solution (A), and the at least one chamber (6), which is filled with the solution (B) for covering the fluid requirement.
8. The multi-chamber bag according to one of the claims 1 to 7, characterized in that the at least one chamber (5), which is filled with the enteral nutrient solution (A), exhibits a connection piece (8A) for removing the enteral nutrient solution.
9. The multi-chamber bag according to claim 8, characterized in that the multi-chamber bag (1) exhibits a hanger (9B) on the side lying opposite the connection piece (8A) for removing the enteral nutrient solution (A).
10. The multi-chamber bag according to one of the claims 1 to 9, characterized in that the at least one chamber (6), which is filled with fluid (B) for covering the fluid requirement, exhibits a connection piece (8B) for removing fluid.
11. The multi-chamber bag according to claim 10, characterized in that the multi-chamber bag (1) exhibits a hanger (9A) on the side lying opposite the connection piece (8B) for removing the fluid (B) covering the fluid requirement.
12. An arrangement with a multi-chamber bag according to one of the claims 1 to 11, characterized in that the multi-chamber bag (1, 16, 17, 22) is enclosed by packaging (20), which contains a device (10) for transferring the enteral nutrient solution (A) and/or the fluid (B) for covering the fluid requirement to the patient.
13. The arrangement according to claim 12, characterized in that the device (10) for transferring the enteral nutrient solution (A) and/or the fluid (B) for covering the fluid requirement exhibits a tube line (11), which exhibits at one end a connection piece (16) for the connection of the device for transferring the enteral nutrient solution to a connection piece of the multi-chamber bag (1, 16, 17, 22) and at the other end a connection piece (23) for connection to a probe for enteral nutrition.
14. The arrangement according to claim 12 or 13, characterized in that the packaging is a bag (20).

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