DE102015200663A1 - Closed multi-compartment container and dietary kit for use in enteral nutrition - Google Patents

Abstract

The invention relates to a closed multi-chamber container for use in enteral nutrition, in particular for the production of enteral nutrient solutions, wherein the multi-chamber container has at least two separate chambers and a first chamber containing a nutrient concentrate and a second chamber containing a enterally administrable liquid. The invention further relates to a dietetic kit for use in enteral nutrition.

Description

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

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

Malnutrition can be the cause of weakening of the immune system, physical weakness, prolonged regeneration phases and the occurrence of wounds, especially poorly healing wounds. This usually leads to a declining quality of life of 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 document EP 1 894 851 A1 known.

Enteral nutrition is a special form of treatment or prevention of malnutrition dar. As enteral nutrition is called in medicine, the supply of a patient with special nutrients through the gastrointestinal tract. Enteral nutrition includes both food and tube feeding. While drinking food is consumed as with a conventional food, the feeding of the tube is either through the nose via a nasogastric tube or directly through the abdominal wall using a PEG (percutaneous endoscopic catering) probe.

Multi-compartment bags for enteral nutrition are from the pamphlets WO 2005/089697 A1 . EP 2 167 011 A1 such as DE 196 05 357 A1 known.

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

The 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 before being administered enterally. This is problematic in that there is a risk of introducing contaminants in the production of such solutions. In addition, depending on the country of delivery (for example, developing or emerging countries), the quality of the water needed to produce nutrient solutions can often not be guaranteed. This represents another potential source of contamination.

The use of nutrient solutions has the fundamental disadvantage that nutrient solutions are characterized by only limited shelf life. Depending on the country of purchase and the delivery time, this can lead to customers receiving a product with already significantly reduced shelf life. This can mean that the product can no longer be administered at all and must be destroyed on the consumer side. Depending on the time of delivery, the limited shelf life of nutrient solutions can even lead to the corresponding products having to be destroyed on the manufacturer side.

Task and solution

Against this background, the present invention has the object to provide a multi-chamber container for use in enteral nutrition, which circumvents the disadvantages mentioned above and in particular allows a high-quality enteral nutrition in reproducible quality from a medical point of view.

This object is achieved by a multi-chamber container having the features of independent claim 1 and by a dietary kit having the features of claim 15. Preferred embodiments of the multi-chamber container are defined in claims 2 to 14. The wording of all claims is hereby incorporated by express reference into the content of the description.

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 multichamber container contains at least one nutrient in solid form or a liquid concentrate containing 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.

For the purposes of the present invention, the term "closed multichamber container" is to be understood as meaning at least one liquid-containing and in particular germ-impermeable, preferably one liquid, air-impermeable and germ-impermeable, multichamber container.

For the purposes of the present invention, the term "liquid concentrate" is to be understood as meaning a liquid, suitably an aqueous liquid, which contains at least one nutrient, wherein the at least one nutrient has a concentration of> 50% by weight, in particular 60% by weight. to 90 wt .-%, preferably 70 wt .-% to 80 wt .-%, based on the total weight of the liquid concentrate.

For the purposes of the present invention, the term "at least one nutrient" is intended to mean a nutrient or a plurality, i. two or more, nutrients, preferably a nutrient mixture understood.

The multichamber container according to the invention offers the following advantages:
The inventively provided at least one nutrient is characterized by a significantly longer shelf life due to its solid state of matter compared to finished 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 destruction of the contents of the multi-chamber container due to an expired shelf life required. Since the multichamber 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 it is also a closed container in the multi-chamber container according to the invention, the production of an enteral nutrient solution within a closed system, in high and in particular reproducible quality is possible. The initially problematized contamination possibilities thus do not exist in the container according to the invention.

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

In a preferred embodiment, the at least one nutrient is lyophilized, i. lyophilized, form before. In other words, according to a preferred embodiment, the first chamber contains a nutrient lyophilisate.

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 has been dried by spray-drying.

In a particularly advantageous embodiment from a durability point of view, the at least one nutrient in solid form is a nutrient powder, preferably lyophilized nutrient powder or spray-dried nutrient powder. As a result, shelf life of well over 12 months can be achieved.

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

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

The at least one nutrient in another embodiment is selected from the group consisting of macronutrients, micronutrients, and mixtures thereof.

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

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

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

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

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

Suitable vitamins may 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 may be selected from the group consisting of fluoride salts, chloride salts, potassium salts, calcium salts, magnesium salts, phosphate salts, sulfate salts, bicarbonate salts and mixtures thereof.

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

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

The water provided according to the invention is also free of trace elements in a further embodiment.

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

In another embodiment, the water is demineralized water, i. around 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. Preferably, the water is ultrapure water having the following properties:

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

The multi-chamber container preferably has a multi-layer, in particular three-layer, constructed wall.

In this case, a chamber facing the chambers layer of a multi-layered, in particular three-layer, constructed wall of a matrix polymer and a phase polymer may be formed. As matrix polymers, polymers with a high excitation or melting temperature range can be used. Accordingly, suitable matrix polymers may be selected from the group consisting of polyethylene, polypropylene, copolymers of polypropylene and mixtures thereof. The polyethylene may be selected from the group consisting of high density polyethylene (HDPE) or linear low density polyethylene (LLDPE). As phase polymers, polymers with a low excitation or melting temperature range can be used. Accordingly, suitable phase polymers may be selected from the group consisting of styrene-ethylene / butylene-styrene triblock polymer (SEBS), styrene-ethylene / butylene-styrene triblock polymer (SEBS) with styrene-ethylene / butylene diblock Moiety (SEB), styrene-ethylene / propylene-styrene triblock polymer (SEPS), styrene-butadiene-styrene triblock polymer (SBS), styrene-isoprene-styrene triblock polymer (SIS), low-density Polyethylene (LDPE), terpolymers of ethylene, propylene and a non-conjugated diene (EPDM), ethylene-α-olefin copolymers and blends thereof. For further details of the aforementioned polymers is on the DE 44 10 876 A1 Reference is made, the disclosure of which is made by express reference to the contents of the present description with respect to the multi-chamber bag materials described therein.

Preferably, a chamber facing the chambers of a multi-layered, in particular three-layer, constructed wall of a homo-phase copolymer of propylene is formed.

A middle layer of a multi-layer, in particular three-layer, constructed wall is preferably formed from a polyolefin, in particular from a polyolefin binder.

An outer layer of a multi-layer, in particular three-layer, constructed wall is preferably formed from a thermoplastic polymer, such as ethylene-vinyl alcohol copolymer or polyvinylidene chloride.

In a further embodiment, the multi-chamber container has a foil-shaped wall.

According to the invention, it is particularly preferred if the multi-chamber container has a wall which is formed from a multilayer film, in particular a three-layer film. The individual layers of the film can be welded together by means of a weld. With regard to suitable film materials, reference is made to the preceding embodiments.

In a further embodiment which is advantageous in terms of quality, a means for eliminating the chamber separation is formed between the first chamber and the second chamber. In this way, a mixing of the first chamber contents with the second chamber contents or vice versa in the closed multi-chamber container and thus in a closed system is possible. An introduction of contaminants during the mixing process can thus be avoided.

Preferably, the means for eliminating the chamber separation is a separable, especially tearable, seam, i. around a so-called peel seam.

In a further embodiment, the multi-chamber container has a removal device for removing an enteral nutrient solution. In principle, the first chamber and / or the second chamber can have such a removal device. According to the invention it can be provided if only the first chamber has a removal device for removing an enteral nutrient solution. The removal device expediently has a pierceable membrane, which allows a sterile closure of the first chamber and / or the second chamber. The removal device is preferably designed as a port.

Administration of the nutrient solution obtained after mixing the chamber contents can basically be effected by gravity or by means of a metering pump. For this purpose, the multi-chamber container in a further embodiment on one of the withdrawal means described in the previous paragraph opposite side of the multi-chamber container on a suspension device. A suitable suspension device may be formed, for example, in the form of a tab or recess of the multi-chamber container. In principle, the first chamber and / or the second chamber may have a suspension device. According to the invention, it can be provided if only the second chamber has a suspension device on a side opposite the removal device.

In a preferred embodiment, the multichamber container according to the invention is a multichamber bag, in particular a two-chamber bag. Preferably, the multi-chamber bag has a structure as in the document EP 0 875 231 A2 the disclosure of which is made with regard to the multichamber bag described therein by express reference to the content of the present description.

In an alternative embodiment, the multi-chamber container has a bottle with a closure lid and a stamp protruding from the closure lid. In this embodiment, one of the chambers, preferably the first chamber, is formed through a cavity of the punch and the other chamber, preferably the second chamber, through the bottle cavity. In other words, in this embodiment it is provided that the at least one nutrient in solid form or the liquid concentrate containing at least one nutrient in a cavity of the stamp and the water inside the bottle, i. contained in the bottle cavity, or vice versa. According to the invention, it is preferred if the at least one nutrient in solid form or the liquid concentrate in the cavity of the stamp and the water in the bottle cavity are contained.

Preferably, upon application of the force, in particular pressurization, the stamp imparts the contents of the cavity, preferably the at least one nutrient or liquid concentrate containing at least one nutrient, into the interior of the bottle, i. into the bottle cavity, free. This results in a mixing of the at least one nutrient or liquid concentrate with the water within the sealed bottle. The resulting nutrient solution can then be administered after opening the bottle.

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

The kit comprises a multi-compartment container according to the first aspect of the invention and a device for administering an enteral nutrient solution to meet the nutrient and fluid requirements of a patient, hereinafter referred to as the administering device.

Administering devices that are familiar to the person skilled in the art are suitable transfer systems for administering nutrient solutions, the details of which do not need to be discussed in greater detail.

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

Further features and advantages of the invention will become apparent from the following description of preferred embodiments with reference to figures, character descriptions and subclaims. In this case, individual features of the invention can be realized on their own or in combination with one another. The preferred embodiments are merely illustrative of the invention, which should in no way be limited thereto.

Figure brief descriptions

The following is shown schematically in the figures:

1 : an embodiment of a multi-chamber container according to the invention,

2 a kit according to the invention,

3 a further embodiment of a multi-chamber container according to the invention and

4a , b: a closure for the in 3 illustrated multi-chamber container

Detailed description of the figures

1 shows a multi-chamber bag 1 for use in enteral nutrition.

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

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

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

To the removal device 11 an administration device can be connected, which with reference to 2 will be described in more detail.

The bag 1 points to one of the withdrawal facility 11 a suspension device on the opposite side 12 on, which is formed in the form of a recess of the multi-chamber bag.

To produce an enteral nutrient solution, the weld is 10 severed, causing the water 9 into the lower chamber 6 arrives. There it comes to a mixing of at least one nutrient 7 and the water 9 , The resulting nutrient solution can then via the sampling device 11 out of the bag 1 be removed.

For administration of the enteral nutrient solution is an administration device 30 which is described below with reference to 2 is described.

2 shows a dietary kit 40 according to the present invention. The kit 40 points next to a multi-chamber bag 1 an administering device 30 on.

The administering device 30 has a hose line 31 on, being at one end of the hose 31 a connection device 32 for connecting the device 30 to the sampling facility 11 of the bag 1 is provided and at the other end of the hose 31 a connection device 33 for connecting the device 30 can be connected to a connection device of a probe tube for enteral nutrition, not shown. The promotion of the nutrient solution can be done solely by gravity. However, it is also possible to use a metering pump, in particular a peristaltic peristaltic pump.

3 shows a multi-chamber container 20 which is a bottle 28 with a closure lid 23 and one from the cap 23 outstanding stamp 26 having. The Stamp 26 has a cavity 26a and the bottle a cavity 28a on.

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

When force is the stamp 26 the stored in him at least one nutrient 27 into the interior of the bottle 28 ie in the bottle cavity 28a free, causing a mixture of at least one nutrient 27 and the water 29 comes. To an unintentional, premature actuation of the stamp 26 To prevent, it may be provided that the multi-chamber container further comprises a cap 21 having, which from the closure lid 23 surrounds outstanding stamp section and which must be removed first, before the multi-chamber container 20 can be used for enteral nutrition.

The release of the at least one nutrient 27 in the cavity 28a For example, it can be based on having one wall of the stamp 26 is destroyed during application of force. For this purpose, for example, perforations in the wall or in a wall portion of the punch 26 be provided.

Alternatively, the multi-chamber container may have a closure, which is formed from two relatively displaceable components, of which the one component has a permeable for the at least one nutrient wall portion, via which the at least one nutrient, however, can be released only after application of force to the closure, which below with reference to 4 is described.

The in 4a Shutter shown has an adapter piece 24 as well as a stamp 26 on. The adapter piece 24 and the stamp 26 are formed relative to each other displaceable. The Stamp 26 contains a cavity 26a , which contains at least one nutrient 27 is filled in solid form. The Stamp 26 has one for the at least one nutrient 27 permeable wall section 26b and a sloping floor 26c on.

In the closed state of the multichamber container 20 - as in 4a shown - is the stamp 26 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 26 On the other hand, it is loaded with a force, it moves relative to the adapter piece 24 , whereby at least a part of the permeable wall section 26b no longer from the adapter piece 24 is edged so that the at least one nutrient 27 over the permeable wall section 26b into the interior of the bottle housing 28 ie in the cavity 28a , can be released (see 4b ).

In particular, after shaking the multi-chamber container 20 An enteric nutrient solution can be provided.

QUOTES INCLUDE IN THE DESCRIPTION

This list of the documents listed by the applicant has been generated automatically and is included solely for the better information of the reader. The list is not part of the German patent or utility model application. The DPMA assumes no liability for any errors or omissions.

Cited patent literature

• EP 1894851 A1 [0004]
• WO 2005/089697 A1 [0006]
• EP 2167011 A1 [0006]
• DE 19605357 A1 [0006]
• DE 4410876 A1 [0042]
• EP 0875231 A2 [0052]

Claims (15)

Closed multi-compartment container for use in enteral nutrition, in particular for the preparation of enteral nutrient solutions, comprising at least two separate chambers, characterized in that a first chamber at least one nutrient in solid form or at least one nutrient-containing liquid concentrate and a second chamber water, which free from organic nutrients. Multi-chamber container according to claim 1, characterized in that it is at least one nutrient in solid form is a nutrient powder. Multi-chamber container according to claim 1, characterized in that it is at least one nutrient-containing liquid concentrate is a syrup. Mehrkammerbehältnis according to any 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 according to one of the preceding claims, characterized in that the water is free of trace elements. Multi-chamber container according to one of the preceding claims, characterized in that it is the water is distilled water. Multi-chamber container according to one of the preceding claims, characterized in that it is the water is demineralized water. Multi-compartment container according to one of the preceding claims, characterized in that the water is ultrapure water. Multi-chamber container according to one of the preceding claims, characterized in that the multi-chamber container has a film-shaped, preferably multi-layer film, formed wall. Multi-chamber container according to one of the preceding claims, characterized in that between the first chamber and the second chamber, a means for eliminating the chamber separation, preferably in the form of a separable seam, is formed. Multi-compartment container according to one of the preceding claims, characterized in that the multi-chamber container has a removal device for removing an enteral nutrient solution and on a side opposite the removal device side a suspension device. Multi-chamber container according to one of the preceding claims, characterized in that it is the multi-chamber container is a multi-chamber bag. Multi-chamber container according to one of claims 1 to 8, characterized in that the multi-chamber container comprises a bottle with a closure lid and a protruding from the closure cap punch, wherein one of the chambers, preferably the first chamber, through a cavity of the punch and the other chamber, preferably the second chamber is defined by the cavity of the bottle. Mehrkammerbehältnis according to claim 13, characterized in that the punch releases the contents of the cavity, preferably the at least one nutrient in solid form or the at least one nutrient-containing liquid concentrate into the bottle when force is applied. Dietetic kit for use in enteral nutrition, in particular for the preparation of enteral nutrient solutions, comprising a multi-compartment container 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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