CN1142757C - Flesible plastic container - Google Patents

Abstract

The objective of the invention is a soft plastic container which is used for separated storage in space and is selectively disinfecting the parenteral or enteral preparation component. The container comprises at least four compartments accomodating respective components, a connecting apparatus with an output which can be opened from outside aseptically among the compartments. The volumetric ratio of the compartment is selected to partly mix in the specific compartment and probably mix all of the components in the compartment 5.

Description

Flesible plastic container

The objective of the invention is one be used on the space separately storage and optionally can sterilize parenteral or enteral with the container preparation composition, that include at least four compartments.

EP-0 295 204 B1 have described a containers for medical use, particularly one comprises by flexibility, the infusion vessel of the shell that even polymeric material is made, it partly is divided into three mutual isolated compartments by the seal welding of sheathing material, and each described compartment all has an energy and is opened by wish so that make the thing in the zone, inner space can flow into the interior passage in another zone, wherein container has two adjacent zones, inner space (3 at an upper portion thereof, 4), zone, an inner space (5) is arranged in its underpart, and be intended to be used for load and only be used for before use subsequently the mixing lipid thing, aminoacid and sugar, wherein each interior zone all has a port blocked; So that should chemical compound by described confession, perhaps discharge its inner thing by described mouth, and wherein the material of shell is chemically and biologically can chemical action not take place with any chemical compound of facing and composition thereof, these sacks have an overpack, wherein, for example be used in combination commercial available oxygen absorbent.

DE94 01 288 U1 relate to a multi-chamber-bag that has two chambers at least, these chambers are arranged to one and center on another and by an outer boundary in mix stages, described chamber is separated mutually by at least one cross bar and is constituted one and go up chamber and a mixing chamber, described bag have at least one be arranged in the cross bar and by one with the connecting device that locking device sealed that is opened, described connecting device provides the mobile connection between each chamber after being opened, described bag on top boundary region has at least one to hang mouthful, a discharger is arranged at the mixing chamber place and have one relative with previous discharger and be disposed in second discharger on the mixing chamber neighboring area.

When the compartment number in the plastic containers of the prior art that is exemplified was given, separating parenteral and enteral in addition was impossible with the separate constituent of preparation.Because the layout of connecting device between the size of compartment and quantity and the compartment, so the composition of the storage that separates on the space and the flexible plastic pouch of optionally sterilizing is impossible.In addition, can not mix the extra composition of leaving arbitrarily in the work of attending doctor in the hospital, for example vitamin, oligo-element or as glutamine.

Therefore, problem of the present invention just provides an improved Flesible plastic container, be used for spatially separately storage and optionally selection sterilization parenteral and enteral preparation composition, described container is except being fit to adorn necessary basis, outside carbohydrate, aminoacid and the fat, also be fit to other extra composition of dress, for example tie up its life, oligo-element, electrolyte, trace element or as glutamine.

The problems referred to above of the present invention are solved by the Flesible plastic container 1 of first embodiment, and it is used for separately storage and optionally selectivity sterilization parenteral and enteral preparation composition on the space, comprising:

At least four compartments 2,3,4 and 5, an intestinal compartment 6 can also be arranged, they are suitable for adorning following thing respectively, in the compartment 2 is trace element, is carbohydrate in the compartment 3, is fat in the compartment 4, in the compartment 5 is Freamine, and, dress electrolyte and/or vitamins in the selectable compartment 6, each container all has one that can seal in the filling on each of opening 7,8,9 and 10 and selectable 11; An outlet 12 is used for for parenteral and enteral preparation constituents mixt; Connecting device 13,13 ', 14,14 ' and 15,15 ' and selectable 16,16 ' can from outside sterilization open, can provide mobile connection between compartment 2,3,4 and 5 and selectable 6 respectively by these connecting devices;

Wherein, compartment 2,3,4 and 5 and selectable 6 volumetric ratio are selected to like this: the place, operating position that when suspension arrangement 17 hangs, is drawn, by open connecting device 13,13 ', 14,14 ' and 15,15 ' and selectable 16,16 ' just might in compartment 5, mix all the components fully;

The volumetric ratio of compartment 2 and compartment 3 is selected to like this: the place, operating position that is drawn when suspension arrangement 17 hangs, might in compartment 3, mix the composition of compartment 2 and 3 fully by opening connecting device 13,13 ' just, and selectively be, compartment 4 is selected to like this with the volumetric ratio of compartment 6: the place, operating position that when suspension arrangement 17 hangs, is drawn by open connecting device 16,16 ', just might in compartment 4, mix the composition of compartment 4 and 6 fully.

By the present invention, might pack parenteral and enteral more selectively in the compartment separately with the preparation composition, part can optionally only be reinjected behind attending doctor's evolution, and makes described composition through special particularly progressively sterilization.In addition, blending constituent selectively makes them be suitable for patient mutually thus, so that obtain uniform mixture, this mode if possible need not medical personnel and spends extra expenditure.Obviously, this need not be filled by compartment when output state, so that can sterilely carry out aseptic mixing to composition.

Fig. 1 to 4 shows a Flesible plastic container 1, includes 5 compartments 2,3,4,5 and 6 respectively.These compartments are suitable for adorning trace element, sulfur hydrate, fat, Freamine and electrolyte and tie up its life.Particularly, the volumetric ratio of compartment is used and becomes to make compartment 2 to be suitable for adorning trace element, compartment 3 to be suitable for adorning that carbohydrate, compartment 4 are suitable for dress fat, compartment 5 is suitable for adorning Freamine and compartment 6 selectively is suitable for adorning electrolyte and/or ties up its life.The composition of described compartment respectively by opening 7,8,9 and 10 and sealing of available 11 places be packed in synchronization or be injected into Flesible plastic container one by one. Connecting device 13,14,15 and 16 be made to can be from the outside aseptic rapid wear valve of opening or rapid wear plug.

According to the filling situation of single compartment (empty or loaded), might give it thus according to structure of the present invention and carry out various aseptic process one by one, in case for example sensitive composition is born high temperature or high-energy radiation by the performance for stability of composition.Thus, aseptic composition can be filled in the already sterilised container, and these containers are filled with heterogeneity and handled with different disinfecting process.

For the nursing administration of constituents mixt, Flesible plastic container 1 has a place, operating position that is drawn when suspension arrangement 17 hangs to be arranged in outlet 12 on the following outer peripheral areas of compartment 5.

By filling compartment minimumly, to hospital's several application possibilities that made up a prescription with carbohydrate (3), fat (4) and aminoacid (5).

At first, might control and only comprise carbohydrate and amino acid whose mixture.By filling compartment 2, might add additive selectively in this mixture.This for control only comprise fat and amino acid whose mixture correct equally.According to the present invention, sack comprises carbohydrate in compartment 3, contains fat and comprise aminoacid in compartment 5 at compartment 4.By open at place, the operating position of bag connecting device 14,14 ', at first produce dual mixing carbohydrate and aminoacid.Then, reblending by opening connecting device 15,15 ' generation three.

According to former technology, by carbohydrate, fat and aminoacid carry out three reblending be favourable, wherein on the one hand, mixing can reach comparatively fast, need not effort (extrusion), and on the other hand, provides very uniform mixture.Work as control period, composition is introduced with the uniform concentration of the height that homogeneous mixture produced.This can prove, for example proves from changing concentration of glucose slightly during sack outflows fast according to mixture when opening connecting device after.Compared with former technology, no longer need fully to stir to obtain uniformity.

In addition, the Hospital Pharmacist has an opportunity one or more compositions are added empty compartment 2 and/or 6, for example mineral, electrolyte, trace element or tie up its life.After adding aseptic compartment, the pharmacists can begin to carry out one or several aseptic partially mixed operation, and simultaneously final married operation is carried out at bedside by the nurse.

Therefore, the container that 4 or 5 compartments are arranged is useful, it makes the pharmacists can add further composition (tieing up its life, electrolyte, oligo-element etc.) in aseptic compartment, and can not make described composition directly contact the remaining composition of bag inclusions, the nurse in patient bedside work can optionally only carry out the final mixing of bag inclusions all the components in the final filling of sack after several days simultaneously.

In the prior art, known have some different connecting devices that the inclusions of compartment 2,3,4 and 5 and available 6 is separated from each other, and allow by opening from the outside composition to be mixed.Therefore, particularly advantageous is in device of the present invention, and connecting device 13,14 and 15 and available 16 is processed to rapid wear valve or rapid wear plug.In Fig. 3 and 4, show plastic containers 1 respectively, but wherein connecting device 13 ', 14 ', 15 ' and available 16 ' be processed to the heat-seal welding of breakaway.In above-mentioned variation, the separated welding of two compartment internal memory things is processed to set up corresponding flowing between compartment by from outside extruding it being torn connects.

The independent compartment not peelable bar of handy heat-sealing is separated from each other.These bars comprise 16 of connecting device 13,14,15 and selection, and they can sterilely be opened from the outside and can provide corresponding flowing to connect between compartment 2,3,4 and 5 and available 6 by them.Except the connecting device 13,14 of Fig. 1 to 4 and 15 and available 16 or substituting as them.Corresponding and unshowned connecting device also is possible on the surface between compartment 3 and 4 or 2 and 6, as long as described compartment connects with common bar.In addition, by the direction of varying dimensions or change declutcher control lever, extra mobile connection is possible, allows on the one hand directly to mix compartment 2 and compartment 4 inclusions, perhaps mix compartment 3 on the other hand and mix, perhaps mix compartment 3 and compartment 4 inclusions with compartment 6 inclusions.But in addition, also be possible, but these breakaway weldings are opened by effect external pressure on bag but one or several heat-sealing breakaway welding is arranged between one or several compartment.

Compartment 2,3,4 and 5 and available 6 volumetric ratio are selected to like this: the place, operating position that is produced when suspension arrangement 17 hangs, by open described connecting device 13,13 ' and 14,14 ' and 15,15 ' and available 16,16 ', then just might be in the compartment 5 that is arranged in the bottom blending constituent fully.For practical operation Flesible plastic container of the present invention, in compartment 5, mix all the components fully, need not medical personnel and push and stirring operation consuming timely, embodied a special advantage.

Compartment 2 is selected to like this with the volumetric ratio of compartment 3: the place, operating position that when suspension arrangement 17 hangs, is produced, by open connecting device 13,13 ', might in compartment 3, mix the composition of compartment 2 and 3 fully.Therefore, before connecting device 14,14 ' mixture flows into compartment 5 after opening, the trace element in the compartment 2 is independently mixed at first with the carbohydrate of compartment 3.

Comprise under the situation of compartment 6 at Flesible plastic container 1 equally, compartment 4 is selected to like this with the volumetric ratio of compartment 6: the place, operating position that is produced when suspension arrangement 17 hangs, after opening connecting device 16, might in compartment 4, mix the composition of compartment 4 and 6 fully.Therefore might open connecting device 15,15 ' after those mixture of ingredients flow into compartments 5 before, make fat in the compartment 4 with at first with the electrolyte of compartment 6 and/or tie up its and order and independently mix, the volume of described compartment 5 is enough to load all the components of all aforementioned compartments.Therefore, might only in described compartment 5, mix all compositions mutually, need not medical personnel and carry out extra work by gravity.

In preferred embodiment of the present invention, container includes four compartments 2,3,4 and 5, and promptly the Flesible plastic container shown in Fig. 1-4 is manufactured into does not have bearing connecting device 16,16 ' and suitably outlet 10 or 11 connecting rod.

In another preferred embodiment of the present invention, still shown in Fig. 1-4, Flesible plastic container connecting device 14,14 ' and 15,15 ' between the bar zone in an extra suspension arrangement 18 is arranged.The like this this device of being recognized from DE94 01 268 U1 is useful, and wherein it at least can be in use and gives the volume that reduces bigger heavy plastic containers during patient's medication.After in compartment 5, mixing each composition, might assign to reduce the apparent volume (apparentvolume) of Flesible plastic container by pulling down the container first half that includes compartment 2,3,4 available 6.

In Fig. 2, show another alternate embodiments according to plastic containers of the present invention, wherein compartment 2 and 6 spatially is separated from each other.This layout usefulness is to be easier to finish independently opening of connecting device 13 and 16.

The bar that at random is loaded with suspension arrangement 18 19 shown in Fig. 3 and 4 has prevented that compartment 3 and 4 compositions from directly mixing before each composition enters compartment, because described mixing is because stability reasons is unwanted.

In another embodiment of the present invention, plastic containers are partly or wholly filled.Particularly advantageous is that compartment 3 is filled carbohydrate, compartment 4 is a fat, and compartment 5 is an aminoacid.Compare with aminoacid when having higher concentration when carbohydrate, might especially easily mix these compositions.

Particularly advantageous sack according to the present invention is not had extra overpack by commercialization.Owing to the fabulous separation of composition that damages mutually makes this become possibility.

Example

In one five compartment sack according to Fig. 2, in compartment 2, contain common trace element water-soluble liquid (10ml), 38.2% glucose solution (655ml) is arranged in compartment 3, common fats emulsion (365ml) is arranged in compartment 4, usually the solution (10ml) that contains its life of dimension is arranged in compartment 6, common Freamine (640ml) is arranged in compartment 5, begin by opening the connecting device 13 and 16 between compartment 3 and 4, prepare the dual mixture of its life of trace element and glucose and dimension and fat respectively.

Subsequently, by opening connecting device 15, preparation dimension its life, fats emulsion and amino acid whose triple mixture.After being emptied completely compartment 4, connecting device 14 is opened and the mixture of all the components obtains in compartment 5.After being emptied completely compartment 3, simulate a injection with speed of 2.5ml/ branch.

The quality of mixture can be observed intuitively.

In order to estimate mixing ratio, after changing efflux time, measure glucose content.

Numerical value is as shown in table 1 below.

Table 1

Time (branch)	Glucose content (g/l) nominal value 148.8g/l
		0	148.0
2	150.4
		5	149.6
10	136.9
		15	151.1

20	150.8
		30	149.6
45	150.4
		60	149.8
90	152.1
		120	148.7
180	149.5
		240	148.8
300	148.8
		360	149.0
420	149.5
		480	149.2
540	148.8
		600	148.8
660	148.8

This table shows if Freamine is arranged in the compartment of bottom and the broken sealing member 15 that fats emulsion and Freamine separate at first to be disconnected, and need not further so, operation just can obtain uniform mixture.

Comparative example

5 Room sacks according to Fig. 2 are studied, the common solution (10ml) that in compartment 2, contains trace element, Freamine (640ml) is arranged in compartment 3, fatty bladder liquid (365ml) is arranged in compartment 4, glucose solution (655ml) is arranged in compartment 5, and its life solution (10ml) of dimension is arranged in compartment 6.

At first, similar to example, the dual mixture of preparation in 3 kind 4 of compartment.

Subsequently, in compartment 5, prepare triple mixture of trace element, aminoacid and glucoses by opening connecting device 14.

After being emptied completely compartment 3, connecting device 15 is opened and the inclusions of compartment 4 is introduced into compartment 5.

As a result, without any being that the mixture of lipomul produces on the other hand for Freamine and glucose on the one hand.Under any circumstance, can between two interfaces, observe a tangible separator bar.

Claims (7)

1. a Flesible plastic container (1) is used for separately storing and optionally sterilize parenteral and enteral composition on the space, comprising:

At least four compartments, i.e. first compartment (2), second compartment (3), the 3rd compartment (4) and the 4th compartment (5), with available the 5th compartment (6), they are suitable for dress trace element in first compartment (2), dress carbohydrate in second compartment (3), dress fat in the 3rd compartment (4), dress Freamine in the 4th compartment (5), and in the 5th compartment (6), adorn electrolyte alternatively and/or tie up its life, have opening (7), (8), (9) and (10) and the available opening (11) that can stop up respectively;

An outlet (12) is used to provide parenteral and enteral mixture of ingredients;

Connecting device (13,13 '), (14,14 ') and (15,15 ') and available connecting device (16,16 '), they can sterilely be opened from the outside, and they can provide the fluid between compartment (2), (3), (4) and (5) and the available compartment (6) to be communicated with respectively;

Wherein

Volumetric ratio between compartment (2), (3), (4) and (5) and the available compartment (6) is chosen as: by opening connecting device (13 at the place, operating position that is provided by suspension arrangement (17), 13 '), (14,14 ') and (15,15 ') and available connecting device (16,16 '), can in the 4th compartment (5), mix all the components fully;

The volumetric ratio of first compartment (2) and second compartment (3) is chosen as: by opening connecting device (13,13 '), can in compartment (3), mix the composition in compartment (2) and (3) fully at the place, operating position that provides by suspension arrangement (17), and

Alternatively, the volumetric ratio of the 3rd compartment (4) and the 5th compartment (6) is chosen as: by opening connecting device (16,16 ') at the place, operating position that is provided by suspension arrangement (17), can mix the composition in compartment (4) and (6) fully in compartment (4).

2. container according to claim 1 is characterized in that, an extra suspension arrangement (18) is positioned in the connecting device (14,14 ') and the bridge region between (15,15 ') between the second and the 3rd compartment (3,4) and the 4th compartment (5).

3. container according to claim 1 and 2 is characterized in that, connecting device (13), (14) and (15) and available connecting device (16) are designed to the form of rapid wear valve and/or rapid wear plug.

4. container according to claim 1 and 2 is characterized in that, connecting device (13 '), (14 ') and/or (15 ') and available connecting device (16 ') but be designed to the form of the heat-sealing welding of breakaway.

5. container according to claim 1 and 2 is characterized in that, compartment (3) contains carbohydrate, and compartment (4) contains fat, and compartment (5) contains Freamine.

6. container according to claim 5 is characterized in that, compartment (2) contains its life of dimension, oligo-element, electrolyte or trace element.

7. container according to claim 5 is characterized in that, compartment (6) contains its life of dimension.

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