EP0315740A2 - Système de conservation, préparation et administration de solutions d'infusion pour la nutrition parentérale - Google Patents
Système de conservation, préparation et administration de solutions d'infusion pour la nutrition parentérale Download PDFInfo
- Publication number
- EP0315740A2 EP0315740A2 EP88113174A EP88113174A EP0315740A2 EP 0315740 A2 EP0315740 A2 EP 0315740A2 EP 88113174 A EP88113174 A EP 88113174A EP 88113174 A EP88113174 A EP 88113174A EP 0315740 A2 EP0315740 A2 EP 0315740A2
- Authority
- EP
- European Patent Office
- Prior art keywords
- containers
- individual
- solutions
- closure
- valves
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Withdrawn
Links
- 235000016236 parenteral nutrition Nutrition 0.000 title claims abstract description 11
- 238000002360 preparation method Methods 0.000 title claims abstract description 7
- 239000003978 infusion fluid Substances 0.000 title claims abstract 3
- 238000004321 preservation Methods 0.000 title 1
- 239000000243 solution Substances 0.000 claims abstract description 31
- 238000002156 mixing Methods 0.000 claims description 25
- 235000015097 nutrients Nutrition 0.000 claims description 21
- 230000008878 coupling Effects 0.000 claims description 10
- 238000010168 coupling process Methods 0.000 claims description 10
- 238000005859 coupling reaction Methods 0.000 claims description 10
- 150000001413 amino acids Chemical class 0.000 claims description 2
- 239000012141 concentrate Substances 0.000 claims 2
- 235000014633 carbohydrates Nutrition 0.000 claims 1
- 150000001720 carbohydrates Chemical class 0.000 claims 1
- 235000013343 vitamin Nutrition 0.000 claims 1
- 229940088594 vitamin Drugs 0.000 claims 1
- 229930003231 vitamin Natural products 0.000 claims 1
- 239000011782 vitamin Substances 0.000 claims 1
- 230000036512 infertility Effects 0.000 abstract 1
- 239000007788 liquid Substances 0.000 description 9
- 239000000203 mixture Substances 0.000 description 5
- 238000011109 contamination Methods 0.000 description 3
- 230000002354 daily effect Effects 0.000 description 3
- 238000002347 injection Methods 0.000 description 3
- 239000007924 injection Substances 0.000 description 3
- 230000005855 radiation Effects 0.000 description 3
- 239000011324 bead Substances 0.000 description 2
- 235000013305 food Nutrition 0.000 description 2
- 230000005484 gravity Effects 0.000 description 2
- 208000015181 infectious disease Diseases 0.000 description 2
- 210000000936 intestine Anatomy 0.000 description 2
- 238000002844 melting Methods 0.000 description 2
- 230000008018 melting Effects 0.000 description 2
- 244000005700 microbiome Species 0.000 description 2
- 238000006243 chemical reaction Methods 0.000 description 1
- 238000010276 construction Methods 0.000 description 1
- 230000001419 dependent effect Effects 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 230000003203 everyday effect Effects 0.000 description 1
- 239000012634 fragment Substances 0.000 description 1
- 230000035876 healing Effects 0.000 description 1
- 230000000968 intestinal effect Effects 0.000 description 1
- 230000001678 irradiating effect Effects 0.000 description 1
- 239000000463 material Substances 0.000 description 1
- 238000000034 method Methods 0.000 description 1
- 230000037081 physical activity Effects 0.000 description 1
- 230000000717 retained effect Effects 0.000 description 1
- 238000007789 sealing Methods 0.000 description 1
- 239000007779 soft material Substances 0.000 description 1
- 238000001356 surgical procedure Methods 0.000 description 1
- 235000013619 trace mineral Nutrition 0.000 description 1
- 239000011573 trace mineral Substances 0.000 description 1
- 239000012780 transparent material Substances 0.000 description 1
- 230000036642 wellbeing Effects 0.000 description 1
Images
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
- A61J3/002—Compounding apparatus specially for enteral or parenteral nutritive solutions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
- A61J1/10—Bag-type containers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/14—Details; Accessories therefor
- A61J1/1475—Inlet or outlet ports
Definitions
- the basic components of the foods required by humans must be administered intravenously as a nutrient solution, in which case one speaks of parenteral nutrition.
- the nutrient solution contains a liquid mixture of the basic components of all food necessary for life, the amount and composition of which depend on the particular daily needs of the individual. These needs can be assessed taking into account age, gender, body type and the extent of physical activity. The reactions of the body so nourished to this nutrient solution must be kept under are sought, so that the attending doctor may then make changes in the composition of the nutrient solution.
- Parenteral nutrition not only takes place in the clinic, but is also increasingly carried out by the patient himself at home, since staying in the familiar environment is an essential factor for well-being and thus accelerating the healing process.
- closure valves are preferably designed such that they can no longer be closed after opening or that once opened, valves can be recognized as such.
- the connecting elements comprise hoses which can be brought irreversibly in the direction of flow via sterilizable coupling pieces.
- Such coupling pieces are e.g. known from DE-OS 28 45 602. With such a system, it is possible to store the individual components ready-made and then to assemble the system according to the instructions of the attending physician by simply connecting the sterilizable coupling pieces.
- the coupling pieces are preferably connected to the manufacturer of the nutrient solutions, so that the simplification is given both for this and later for use in the patient.
- This system is also particularly advantageous for parenteral nutrition in the clinic, since the clinical staff can then put together the individual solutions quickly and without risk of contamination.
- the system shown in Fig. 1 comprises a number of larger mixing containers 10, 10 ', 10 ⁇ and several small mixing containers 20, 20', 20 ⁇ , which are each made of plastic and deformable.
- At inlet nozzle 12, 13 of the container 10, outlet nozzle 21, 21 'of the smaller container 20, 20' are connected via hose lines 14, in which closure valves 50 and check valves 22 are provided.
- the container 10 ' is only in connection with a small container 20 ⁇ , with an injection piece 18 being provided in the hose line 14 of this connection, in order to optionally supply a further additional solution via an injection syringe 19.
- the containers 10, 10 'and 10' are connected to the inlet ends of a branching piece 15 via outlet connections 11, 11 ', 11', the output of which via a common outflow line 25 for the containers 10, 10 'and 10' with an inlet connection 32 of a mixing bag 30 communicating.
- closure valves 50 and check valves 22 are also provided in the connecting lines between the containers 10, 10 'and 10 ⁇ to the mixing bag 30 in the connecting lines between the containers 10, 10 'and 10 ⁇ to the mixing bag 30, closure valves 50 and check valves 22 are also provided.
- the mixing bag 30 has at its outlet connection 31 an outlet line 26 which can be opened and blocked by means of a roller clamp 25 and (initially) is tightly closed by an end cap 17. After opening the end cap 17, it can be connected to the input end of a catheter 23.
- the hose lines are designed with respect to their length so that the smaller bags 20, 20 ', 20 ⁇ above the larger bags 10, 10', 10 ⁇ can be hung, so that after opening the closure valves 50th between the small bags 20 and the large bags 10, the contents of the small bags can initially flow into the large bags due to gravity.
- the system shown in FIG. 1 thus corresponds to the conventional mixing bag system, in which a mixing bag 30 is first filled with the individual liquids before the nutrient solution is supplied to the patient via the catheter 23.
- This mixing bag 30 can be filled either by gravity alone or via a vacuum filling device known per se.
- a disconnection coupling is preferably provided between the branching piece 15 and the inlet connection 32 of the mixing bag 30, which is designed such that when the patient (or the clinic staff) has completely filled the mixing bag 30 , the mixing bag 30 can be separated from the now empty bags and sealed at its inlet port 32, so that the mixing bag 30 can then be hung on a frame and the liquid contained in it can be applied.
- the overall system shown in Fig. 1 thus consists of the filled bags 10, 10 ', 10 ⁇ , 20, 20', 20 ⁇ , which are filled with each other and with the mixing bag 30 via the lines shown, the output line 26 of which is initially via the End cap 17 is closed. Since the valves 50 and also the end cap 17 are closed, that is to say the liquids are stored separately from one another, the overall arrangement can easily be kept in stock for a long time and remains sterile. It is only when a "daily ration" is prepared that the valves 50 are opened in succession (possibly also simultaneously) and the mixing bag 30 is filled. After this filling, the mixing bag 30 is separated, the end cap 17 is removed and the outlet line 26 is optionally connected to the catheter 23 via a drip device or a roller pump and the nutrient solution is applied.
- FIG. 2 differs from that of FIG. 1 in that no mixing container 30 is provided, but rather the nutrient liquids directly via branching Pieces 15 are guided to a common outflow line 25 which can be connected to the catheter 23 via a drip container 16 and an outlet line 26.
- a roller clamp 24 is provided in the outflow line 25 for adjusting the feed speed.
- This arrangement has the essential advantage over that of FIG. 1 that the individual container contents can be applied in a sequence prescribed by the attending physician. If this arrangement is connected to the configuration of containers 10 and 20 shown in FIG. 1, the patient can first open the shut-off valves 50 in the lines 14 of the small containers, 20, 20 ', 20 ⁇ , so that the contents thereof enter into the connected larger containers 10, 10 'flow.
- the patient can open the shut-off valves 50 of the containers 10, 10 'and 10 ⁇ in succession and (with a suitable setting of the roller clamp 24) apply the partial mixtures or pure liquids.
- a container filled with rinsing liquid eg together with trace elements
- Such a choice of the sequence was previously only possible in clinics and can now be carried out in a very simple manner by the patient himself, without there being an increased risk of infection.
- each hose line 14 is plugged onto a correspondingly shaped connection piece of a housing 43, the interior 44 of which communicates with the interior of the hose 14 and is sealed by a closure plate 45. The interior of the assembly is sterilized.
- Each of the housing 43 has on the one hand an opening 42, 42 ', on the other hand a hook 41, 41', which are arranged such that when closed put together of two housings 43, 43 'the two closing plates 45, 45' come to rest on each other and hook '41' in the opening 42, the hook 41 in the opening 42 ', so that the arrangement is mechanically locked.
- the interiors 44, 44 'of the two housings 43 and thus the hose sections 14 and 14' are initially still separated from each other.
- the housing 43, 43 ' are made of optically transparent material, while the closure plates 45 consist of optically dense and relatively easily meltable material. If one now exposes the arrangement of a heat radiation source which has been put together in this way, the heat radiation penetrates the housing 43 without damaging it, while the closure plates 45 absorb the radiation and thereby melt together. Simultaneously with the melting, there is a connection opening 46 between the two interiors 44 and 44 'of the housing 43 and 43', which is surrounded by a bead 47. The melting bead 47 simultaneously connects the two housings 43, 43 'with high mechanical strength. This type of connection makes it possible to create a connection between two tubes 14 without causing the slightest risk of contamination with microorganisms.
- a large number of pre-assembled containers 10 and 20 can therefore be stored in order to then be connected, if required, by simply plugging them together and irradiating them to form a system which corresponds to the medical instructions.
- This connection is preferably made at the manufacturer of the nutrient solutions or in the clinic, but it is also possible for the patient to plug and fuse them himself.
- FIG. 5 shows a possibility of a closure valve 50, which can either be inserted into a hose 14 in a separate housing (see FIGS. 1 and 4) or the closure valve 50 is directly in an egg NEN outlet 11 of the associated container 10 (or 20) installed.
- a built-in valve is shown in FIG. 5 and comprises a holder 53 which holds a pipe 51 which can be broken off at a notch and seals in the outlet connection 11. The tube 51 is melted at the end and is connected at its other end to the contents of the bag 10.
- a sieve 52 is arranged in the outlet nozzle 11, so that when the breaking tube 51 has been broken off at the notch provided there, which the operator can do by simply kinking the outlet nozzle 11 made of soft material, the fragment is retained on the sieve 52.
- a break valve instead of such a break valve, a normal valve with a chick can also be used, in which case a sealing tab is preferably provided above the shut-off valve, so that it can be seen from the outside whether the valve has already been opened or not.
- an essential criterion of the invention is that a system, prefabricated in its essential components, can be produced from containers filled with individual liquids, which, together with their connecting lines, are sterile and remain due to the end caps 17 so that the components of the nutrient solutions can be stored separately. Only when the correctly mixed nutrient solution is to be applied, or when the nutrient solutions are to be applied in succession, are the shut-off valves (irreversibly) opened, which in turn means that no tools are required and there is therefore no risk of contamination.
- the check valves 22 in the lines 14 (possibly also in the line 26) prevent liquid flow in the wrong direction, so that incorrect operation can be reliably avoided.
- the containers are preferably designed as plastic bags, so that when filling (container 20 in container 10) or emptying no openings have to be provided for pressure equalization via the atmosphere, the system itself can be tight.
- the connecting hoses are preferably welded to the corresponding connections, valves, etc.
Landscapes
- Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Nutrition Science (AREA)
- Hematology (AREA)
- Infusion, Injection, And Reservoir Apparatuses (AREA)
- Medical Preparation Storing Or Oral Administration Devices (AREA)
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| DE19873738162 DE3738162A1 (de) | 1987-11-10 | 1987-11-10 | System zur aufbewahrung, zubereitung und applikation von infusionsloesungen fuer die parenterale ernaehrung |
| DE3738162 | 1987-11-10 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| EP0315740A2 true EP0315740A2 (fr) | 1989-05-17 |
| EP0315740A3 EP0315740A3 (fr) | 1989-08-30 |
Family
ID=6340202
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| EP88113174A Withdrawn EP0315740A3 (fr) | 1987-11-10 | 1988-08-12 | Système de conservation, préparation et administration de solutions d'infusion pour la nutrition parentérale |
Country Status (2)
| Country | Link |
|---|---|
| EP (1) | EP0315740A3 (fr) |
| DE (1) | DE3738162A1 (fr) |
Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE3926395C1 (en) * | 1989-08-10 | 1991-03-07 | Fresenius Ag, 6380 Bad Homburg, De | Infusion system for feeding patient - uses two bags held in frame with complementary connection pieces |
| DE19939219A1 (de) * | 1999-08-18 | 2001-03-01 | Fritz Giebler Gmbh | Verfahren und Vorrichtung zum Herstellen von Gemischen pharmazeutischer Flüssigkeiten |
| EP1417950A1 (fr) * | 2002-11-08 | 2004-05-12 | Haemopharm Industry Ag | Dispositif pour administrer par voie parentérale des mixtures nutritives |
| FR2852259A1 (fr) * | 2003-03-11 | 2004-09-17 | Stedim Sa | Procede et dispositif a usage unique d'echantillonnage et de repartition de liquide, notamment en conditions steriles |
| EP2628474A1 (fr) | 2011-10-28 | 2013-08-21 | optiferm GmbH | Sac destiné à approvisionner et extraire un additif liquide sous conditions aseptiques |
| WO2014184121A1 (fr) * | 2013-05-15 | 2014-11-20 | Hameln Rds Gmbh | Procédé de remplissage de seringues pour pompes doseuses |
Family Cites Families (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US3205889A (en) * | 1962-07-23 | 1965-09-14 | Abbott Lab | Parenteral fluid container and port structure |
| US3187750A (en) * | 1963-01-15 | 1965-06-08 | Baxter Laboratories Inc | Multiple bag blood storage unit |
| FR2098873A5 (fr) * | 1970-07-30 | 1972-03-10 | Labaz Laboratoires | |
| US4157723A (en) * | 1977-10-19 | 1979-06-12 | Baxter Travenol Laboratories, Inc. | Method of forming a connection between two sealed conduits using radiant energy |
| DE2855713C2 (de) * | 1978-12-22 | 1983-09-22 | Manfred Dr.med. 2000 Hamburg Doehn | Vorrichtung zur Infusion von Lösungen aus mehreren Infusionsflaschen |
| DE8012958U1 (de) * | 1980-05-13 | 1980-08-14 | B. Braun Melsungen Ag, 3508 Melsungen | Infusionsvorrichtung |
| DE3024768C2 (de) * | 1980-06-30 | 1983-09-22 | Baxter Travenol Laboratories, Inc., 60015 Deerfield, Ill. | Anordnung für die Herstellung parenteraler Nährlösungen |
| US4368729A (en) * | 1980-10-14 | 1983-01-18 | Baxter Travenol Laboratories, Inc. | Aseptic system for total parenteral nutrition and the like |
| US4692144A (en) * | 1984-08-20 | 1987-09-08 | Alza Corporation | System for providing intravenously administrable drug formulation |
| DE8520973U1 (de) * | 1985-07-20 | 1985-08-29 | Aigner, Karl, Dr., 6301 Pohlheim | Katheter zur intraoperativen Chemoembolisation |
-
1987
- 1987-11-10 DE DE19873738162 patent/DE3738162A1/de not_active Ceased
-
1988
- 1988-08-12 EP EP88113174A patent/EP0315740A3/fr not_active Withdrawn
Cited By (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE3926395C1 (en) * | 1989-08-10 | 1991-03-07 | Fresenius Ag, 6380 Bad Homburg, De | Infusion system for feeding patient - uses two bags held in frame with complementary connection pieces |
| DE19939219A1 (de) * | 1999-08-18 | 2001-03-01 | Fritz Giebler Gmbh | Verfahren und Vorrichtung zum Herstellen von Gemischen pharmazeutischer Flüssigkeiten |
| DE19939219C2 (de) * | 1999-08-18 | 2001-10-18 | Fritz Giebler Gmbh | Vorrichtung zum Herstellen von Gemischen pharmazeutischer Flüssigkeiten |
| EP1417950A1 (fr) * | 2002-11-08 | 2004-05-12 | Haemopharm Industry Ag | Dispositif pour administrer par voie parentérale des mixtures nutritives |
| FR2852259A1 (fr) * | 2003-03-11 | 2004-09-17 | Stedim Sa | Procede et dispositif a usage unique d'echantillonnage et de repartition de liquide, notamment en conditions steriles |
| EP2628474A1 (fr) | 2011-10-28 | 2013-08-21 | optiferm GmbH | Sac destiné à approvisionner et extraire un additif liquide sous conditions aseptiques |
| EP2628474B1 (fr) * | 2011-10-28 | 2018-11-28 | optiferm GmbH | Sac destiné à approvisionner et extraire un additif liquide sous conditions aseptiques |
| WO2014184121A1 (fr) * | 2013-05-15 | 2014-11-20 | Hameln Rds Gmbh | Procédé de remplissage de seringues pour pompes doseuses |
Also Published As
| Publication number | Publication date |
|---|---|
| DE3738162A1 (de) | 1989-05-24 |
| EP0315740A3 (fr) | 1989-08-30 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| PUAI | Public reference made under article 153(3) epc to a published international application that has entered the european phase |
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| AK | Designated contracting states |
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| 17P | Request for examination filed |
Effective date: 19891116 |
|
| RAP1 | Party data changed (applicant data changed or rights of an application transferred) |
Owner name: BAXTER INTERNATIONAL INC. |
|
| 17Q | First examination report despatched |
Effective date: 19910313 |
|
| STAA | Information on the status of an ep patent application or granted ep patent |
Free format text: STATUS: THE APPLICATION IS DEEMED TO BE WITHDRAWN |
|
| 18D | Application deemed to be withdrawn |
Effective date: 19910724 |