DE102015200663B4 - Closed multi-chamber container and diet kit for use in enteral nutrition - Google Patents

Abstract

Closed multi-chamber container (20) for use in enteral nutrition, in particular for the production of enteral nutrient solutions, having at least two separate chambers (26a; 28a), a first chamber (26a) at least one nutrient in solid form (27) or at least one a liquid concentrate containing nutrients and a second chamber (28a) containing water which is free of organic nutrients, characterized in that the multi-chamber container (20) has a closure which has an adapter piece (24) and a stamp (26), wherein the adapter piece (24) and the stamp (26) are designed to be displaceable relative to one another, the stamp (26) has a cavity (26a) which is filled with the at least one nutrient in solid form (27) or the at least one nutrient-containing liquid concentrate, and the stamp (26) contains one for the at least one nutrient in solid form (27) or the at least one nutrient containing liquid concentrate has a permeable wall section (26b) and an inclined base (26c), wherein in the closed state of the multi-chamber container (20) the stamp (26) is completely enclosed along the wall section (26b) by the adapter piece (24) and the stamp ( 26) moves relative to the adapter piece (24) when force is applied, as a result of which at least part of the permeable wall section (26b) is no longer enclosed by the adapter piece (24), so that the at least one nutrient in solid form (27) or at least one nutrient containing Liquid concentrate can be released into the interior of a bottle housing (28) via the permeable wall section (26b).

Description

Field of application and state of the art

The invention relates to a closed multi-chamber container and a diet kit for use in enteral nutrition.

The treatment of malnutrition is an important task of modern medical care. In general, chronic illnesses, digestive problems, chewing and swallowing disorders or loss of appetite can lead to malnutrition.

Malnutrition can be the cause of a weakened immune system, physical weakness, prolonged regeneration phases and the appearance of wounds, especially wounds that do not heal well. This usually leads to a declining quality of life for those affected and increased treatment and care costs.

The treatment of malnutrition usually requires the supply of special nutrients. These are usually stored in so-called multi-chamber bags. A corresponding bag is for example from the publication EP 1 894 851 A1 known.

Enteral nutrition is a special form of treatment or prevention of malnutrition. In medicine, enteral nutrition is the term used to describe the supply of a patient with special nutrients via the gastrointestinal tract. Enteral nutrition includes both sip feed and tube feed. While drinking food is consumed in the same way as conventional food, the tube feeding is placed either through the nose using a nasogastric tube or directly through the abdominal wall using a PEG (percutaneous endoscopic gastronomy) tube.

Multi-chamber bags for enteral nutrition are from the publications WO 2005/089697 A1 , EP 2 167 011 A1 , DE 697 26 715 T2 such as DE 196 05 357 A1 known.

Furthermore, a multi-chamber bag for hemodialysis or peritoneal dialysis is from the DE 10 2009 058 445 A1 known.

Furthermore, a device for removing liquids from medical containers from the DE 101 43 537 A1 and a device for adding a selected component to a main package from the EP 2 341 008 B1 known.

The use of a nutritional composition for the manufacture of a liquid composition for the nutritional management of diabetes symptoms in patients is disclosed in US Pat DE 698 18 594 T2 known.

A device with a cap which, when a force is applied, comes into contact with a spike element and thereby releases a component stored in it into a container, is from the US 2012/0211459 A1 known.

The applicant provides a commercially available under the name Nutricomp ^® Single Chamber for enteral nutrition and a multi-chamber bag under the name Nutriflex ^® on parenteral nutrition.

The well-known multi-chamber bags for enteral nutrition usually contain nutrient powder or nutrient solutions.

If nutrient powders are used, they must be converted into a nutrient solution prior to enteral administration. This is problematic insofar as there is a risk of the introduction of contaminants in the production of such solutions. In addition, depending on the supplier country (e.g. developing or emerging countries), the quality of the water required for the production of nutrient solutions can often not be guaranteed. This is another potential source of contamination.

The use of nutrient solutions has the fundamental disadvantage that nutrient solutions only have a limited shelf life. Depending on the country of purchase and the delivery time, this can mean that the customer receives a product with a significantly reduced shelf life. This can mean that the product can no longer be administered at all and must be destroyed by the customer. The limited shelf life of nutrient solutions can, depending on the time of delivery, even mean that the relevant products have to be destroyed by the manufacturer.

Task and solution

Against this background, the present invention was based on the object of providing a multi-chamber container for use in enteral nutrition which circumvents the disadvantages mentioned at the outset and in particular enables enteral nutrition of reproducible quality from a medical point of view.

This object is achieved by a multi-chamber container with the features of independent claim 1 and by a diet kit with the features of claim 9. Preferred embodiments of the multi-chamber container are defined in claims 2 to 8. The wording of all claims is hereby made part of the content of the description by express reference.

According to a first aspect, the invention relates to a closed multi-chamber container, in particular a two-chamber container, for use in enteral nutrition, in particular for the production of enteral nutrient solutions.

The multi-chamber container has at least two separate chambers.

A first chamber of the multi-chamber container contains at least one nutrient in solid form or a liquid concentrate which contains at least one nutrient.

A second chamber of the multi-chamber container contains water which is free from organic nutrients such as amino acids, proteins, carbohydrates, monosaccharides, oligosaccharides, polysaccharides, fats and the like.

In the context of the present invention, the expression “closed multi-chamber container” is to be understood as meaning at least one multi-chamber container which is impermeable to liquids and, in particular, to germs, preferably one which is impermeable to liquids, air and germs.

In the context of the present invention, the expression “liquid concentrate” should be understood to mean a liquid, expediently an aqueous liquid, which contains at least one nutrient, the at least one nutrient having a concentration of> 50% by weight, in particular 60% by weight to 90% by weight, preferably 70% by weight to 80% by weight, based on the total weight of the liquid concentrate.

In the context of the present invention, the expression “at least one nutrient” should be understood to mean one nutrient or a plurality, i.e. two or more, nutrients, preferably a nutrient mixture.

The multi-chamber container according to the invention offers the following advantages:

The at least one nutrient provided according to the invention is characterized by a significantly longer shelf life due to its solid state of aggregation compared to ready-made solutions. Due to the lack of organic nutrients, this also applies to the water provided according to the invention. As a result, a supply of high-quality nutrient solutions can be ensured even over longer storage and delivery times without the need to destroy the contents of the multi-chamber container due to the expiry date being exceeded. Since the multi-chamber container according to the invention already contains water for the production of an enteral nutrient solution, there is also no dependence on the water quality available in the respective customer country. Since the multi-chamber container according to the invention is also a closed container, it is possible to produce an enteral nutrient solution within a closed system, to be precise in a high and, in particular, reproducible quality. The contamination possibilities initially problematical therefore do not exist in the case of the container according to the invention.

By means of the multi-chamber container according to the invention, a supply of high quality enteral nutrient solutions can thus be ensured globally, regardless of delivery and storage times.

In a preferred embodiment, the at least one nutrient is in freeze-dried, i.e. lyophilized, form. In other words, according to a preferred embodiment, the first chamber contains a nutrient lyophilizate.

In an alternative embodiment, the at least one nutrient is in spray-dried form. In other words, in an alternative embodiment, the first chamber contains at least one nutrient in solid form, which is dried by means of spray drying.

In an embodiment which is particularly advantageous from the point of view of shelf life, the at least one nutrient in solid form is a nutrient powder, preferably lyophilized nutrient powder or spray-dried nutrient powder. This enables shelf life of significantly more than 12 months to be achieved.

In contrast, the liquid concentrate is preferably in the form of a syrup.

In a further embodiment, the at least one nutrient in solid form or the syrup is a dietary food.

In a further embodiment, the at least one nutrient is selected from the group consisting of macronutrients, micronutrients and mixtures thereof.

The at least one nutrient is preferably selected from the group consisting of protein components, carbohydrates, fats, vitamins, roughage, antioxidants, minerals, trace elements, flavorings and mixtures thereof.

Suitable protein components can be selected from the group consisting of milk protein, soy protein, whey protein, gelatin, casein, cocoa protein and mixtures thereof.

Suitable fats can be selected from the group consisting of fats with saturated fatty acids, MCT (medium chain triglycerides), fats with essential fatty acids, fats with omega-3 fatty acids, soybean oil, fish oil, rapeseed oil, sunflower oil, cocoa oil and mixtures thereof.

Suitable carbohydrates can be selected from the group consisting of glucose, fructose, lactose, maltose, sucrose, oligosaccharides, polysaccharides, maltodextrin, starch (such as tapioca starch and / or corn starch) and mixtures thereof.

Suitable fiber can come from corn, oats, or soy. Suitable dietary fiber can therefore be selected, for example, from the group consisting of soluble dietary fiber, insoluble dietary fiber, inulin, wheat dextrin, resistant starch, cocoa, cellulose and mixtures thereof.

Suitable vitamins can be selected from the group consisting of vitamin A, vitamin D, vitamin E, vitamin K, vitamin B ₁ , vitamin B ₂ , vitamin B ₆ , vitamin B ₁₂ , vitamin C, niacin, folic acid, pantothenic acid, biotin, choline , β-carotene, and mixtures thereof.

Suitable minerals can be selected from the group consisting of fluoride salts, chloride salts, potassium salts, calcium salts, magnesium salts, phosphate salts, sulfate salts, hydrogen carbonate salts and mixtures thereof.

Suitable trace elements can be selected from the group consisting of zinc, copper, iodine, chromium, manganese, molybdenum, selenium and mixtures thereof.

Suitable flavors or aromas can be selected from the group consisting of natural aromas such as vanillin and / or fruit aromas, synthetic aromas such as ethylvanillin, nature-identical aromas and mixtures thereof.

In a further embodiment, the water provided according to the invention is also free from trace elements.

The water provided according to the invention is preferably distilled water, in particular one or more times, preferably two or three times, distilled water.

In a further embodiment, the water is demineralized water, i.e. water which is free from mineral salts.

• - Leitfähigkeit ≤1.1 µS/cm bei 20°C
• - Bakterielle Endotoxine < 0.25 i.E. (infektiöse Einheiten)/ml (entspricht ca. 25 ng/l)
• - Gesamter organischer Kohlenstoff (TOC-Wert) ≤ 0.5 mg/l
• - Nitrat ≤ 0.2 mg/l.

In a further embodiment, the water is ultrapure water. The water is preferably ultrapure water with the following properties:

• - Conductivity ≤1.1 µS / cm at 20 ° C
• - Bacterial endotoxins <0.25 iU (infectious units) / ml (corresponds to approx. 25 ng / l)
• - Total organic carbon (TOC value) ≤ 0.5 mg / l
• - Nitrate ≤ 0.2 mg / l.

The multi-chamber container has a bottle with a closure lid and a stamp protruding from the closure lid. The first chamber is formed by a cavity of the plunger and the second chamber by the bottle cavity. According to the invention, the at least one nutrient is contained in solid form or the liquid concentrate is contained in the cavity of the stamp and the water is contained in the bottle cavity.

When force is applied, in particular pressure is applied, the stamp releases the contents of the cavity, namely the at least one nutrient or the liquid concentrate containing at least one nutrient, into the interior of the bottle, i.e. into the bottle cavity.

As a result, the at least one nutrient or the liquid concentrate is mixed with the water inside the closed bottle. The resulting nutrient solution can then be administered after opening the bottle.

According to a second aspect, the invention relates to a diet kit for use in enteral nutrition, in particular for the production of enteral nutrient solutions.

The kit has a multi-chamber container according to the first aspect of the invention and a device for administering an enteral nutrient solution to cover the nutrient and Fluid requirement of a patient, hereinafter referred to as the administration device.

As the administration devices, transfer systems known per se to the person skilled in the art for administering nutrient solutions come into consideration, the more detailed configurations of which consequently need not be discussed in more detail.

With regard to further features and advantages of the kit, in particular the multi-chamber container, reference is made in full to the statements made in the context of the first aspect of the invention in order to avoid repetition.

Further features and advantages of the invention emerge from the following description of preferred embodiments with reference to figures, figure descriptions and subclaims. Individual features of the invention can be implemented individually or in combination with one another. The preferred embodiments serve only to explain the invention, which is in no way intended to be restricted thereto.

Figure list

• 1: eine Ausführungsform eines nicht erfindungsgemäßen Mehrkammerbehältnisses,
• 2: ein nicht erfindungsgemäßes Kit,
• 3: eine Ausführungsform eines erfindungsgemäßen Mehrkammerbehältnisses und
• 4a, b: ein Verschluss für das in 3 dargestellte Mehrkammerbehältnis

The following is shown schematically in the figures:

• 1 : an embodiment of a multi-chamber container not according to the invention,
• 2 : a kit not according to the invention,
• 3 : an embodiment of a multi-chamber container according to the invention and
• 4a, b : a closure for the in 3 multi-chamber container shown

Detailed description of the figures

1 shows a multi-chamber bag not according to the invention 1 for use in enteral nutrition.

The bag 1 is made of three superimposed flexible plastic films 2 , 3 , 4th on their edges by means of a circumferential weld seam 5 are welded together, formed.

The bag 1 has a lower chamber 6th and an upper chamber 8th on. The lower chamber 6th is with at least one nutrient 7th in solid form, preferably a nutrient powder, filled, whereas the upper chamber 8th with water 9 which is free of organic nutrients is filled. Both chambers 6th , 8th are by means of a separable weld seam 10 separated from each other.

The bag 1 has a removal device 11th for withdrawing an enteral nutrient solution. From the point of view of mixing, it is advantageous if such a removal device, as in 1 shown, in the area of the lower chamber 6th is provided. The extraction device 11th has a pierceable membrane 11a on, which after removal of an enteral nutrient solution again a sterile closure of the multi-chamber bag 1 enables.

To the extraction facility 11th an administration device can be connected, which is described with reference to FIG 2 will be described in more detail.

The bag 1 points to one of the removal devices 11th opposite side a suspension device 12th on, which is designed in the form of a recess in the multi-chamber bag.

The weld seam is used to produce an enteral nutrient solution 10 severed, causing the water 9 into the lower chamber 6th got. There the at least one nutrient is mixed 7th and the water 9 . The resulting nutrient solution can then be used via the extraction device 11th out of the bag 1 can be removed.

An administration device is used to apply the enteral nutrient solution 30th , which is described below with reference to 2 is described.

2 shows a dietary kit not according to the invention 40 according to the present invention. The kit 40 has next to a multi-chamber bag 1 a delivery device 30th on.

The delivery device 30th has a hose line 31 on, being at one end of the hose assembly 31 a connection device 32 to connect the device 30th to the extraction facility 11th of the bag 1 is provided and at the other end of the hose line 31 a connection device 33 to connect the device 30th can be connected to a connection device of a probe tube (not shown) for enteral nutrition. The nutrient solution can be promoted solely by gravity. However, a metering pump, in particular a peristaltic hose pump, can also be used.

3 shows a multi-chamber container 20th what a bottle 28 with a sealing cap 23 and one from the cap 23 outstanding stamp 26th having. The Stamp 26th has a cavity 26a and the bottle has a cavity 28a on.

The cavity 26a is provided as the first chamber in the sense of the present invention and contains at least one nutrient 27 in solid form, whereas the bottle cavity 28a is provided as a second chamber within the meaning of the present invention and water 29 which is free from organic nutrients.

When force is applied, the stamp gives 26th the at least one nutrient stored in it 27 inside the bottle 28 , ie in the bottle cavity 28a free, causing the at least one nutrient to mix 27 and the water 29 comes. Unintentional, premature actuation of the stamp 26th To prevent this, it can be provided that the multi-chamber container also has a closure cap 21 has, which the from the cap 23 Surrounding protruding stamp section and which must first be removed before the multi-chamber container 20th can be used for enteral nutrition.

The multi-chamber container has a closure which is formed from two components which are designed to be displaceable relative to one another, one of which has a wall section permeable to the at least one nutrient, via which the at least one nutrient can, however, only be released after force has been applied to the closure, which follows with reference to 4th is described.

The in 4a The closure shown has an adapter piece 24 as well as a stamp 26th on. The adapter piece 24 and the stamp 26th are designed to be displaceable relative to one another. The Stamp 26th contains a cavity 26a , which one with at least one nutrient 27 is filled in solid form. The Stamp 26th assigns one to the at least one nutrient 27 permeable wall section 26b and a sloping floor 26c on.

When the multi-chamber container is closed 20th - as in 4a depicted - is the stamp 26th along the wall sections 26b completely from the adapter piece 24 edged. A release of the at least one nutrient 27 over the permeable wall section 26b is not possible in this state.

Will the stamp 26th on the other hand, when a force is applied, it moves relative to the adapter piece 24 whereby at least part of the permeable wall section 26b no longer from the adapter piece 24 is framed so that the at least one nutrient 27 over the permeable wall section 26b into the inside of the bottle housing 28 , ie in the cavity 28a , can be released (see 4b) .

Especially after shaking the multi-chamber container 20th an enteral nutrient solution can be provided.

Claims (9)

Closed multi-chamber container (20) for use in enteral nutrition, in particular for the production of enteral nutrient solutions, having at least two separate chambers (26a; 28a), a first chamber (26a) at least one nutrient in solid form (27) or at least one a liquid concentrate containing nutrients and a second chamber (28a) containing water which is free of organic nutrients, characterized in that the multi-chamber container (20) has a closure which has an adapter piece (24) and a stamp (26), wherein the adapter piece (24) and the stamp (26) are designed to be displaceable relative to one another, the stamp (26) has a cavity (26a) which is filled with the at least one nutrient in solid form (27) or the at least one nutrient-containing liquid concentrate, and the stamp (26) contains one for the at least one nutrient in solid form (27) or the at least one nutrient e The wall section (26b) containing the liquid concentrate has a permeable wall section (26b) and an inclined base (26c), wherein in the closed state of the multi-chamber container (20) the stamp (26) is completely enclosed along the wall section (26b) by the adapter piece (24) and the stamp ( 26) moves relative to the adapter piece (24) when a force is applied, as a result of which at least part of the permeable wall section (26b) is no longer enclosed by the adapter piece (24), so that the at least one nutrient in solid form (27) or at least one nutrient containing it Liquid concentrate can be released into the interior of a bottle housing (28) via the permeable wall section (26b). Multi-chamber container (20) according to Claim 1 , characterized in that the at least one nutrient in solid form (27) is a nutrient powder. Multi-chamber container (20) according to Claim 1 , characterized in that the liquid concentrate containing at least one nutrient is a syrup. Multi-chamber container (20) according to one of the preceding claims, characterized in that the at least one nutrient is selected from the group consisting of protein components, carbohydrates, fats, vitamins, fiber, Antioxidants, minerals, trace elements and mixtures thereof. Multi-chamber container (20) according to one of the preceding claims, characterized in that the water is free from trace elements. Multi-chamber container (20) according to one of the preceding claims, characterized in that the water is distilled water. Multi-chamber container (20) according to one of the preceding claims, characterized in that the water is demineralized water. Multi-chamber container (20) according to one of the preceding claims, characterized in that the water is ultrapure water. Dietary kit for use in enteral nutrition, in particular for the production of enteral nutrient solutions, comprising a multi-chamber container (20) according to one of the preceding claims and a device for administering an enteral nutrient solution to cover the nutrient and fluid requirements of a patient.

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