EP0993819B1 - Poche contenant deux substances séparées devant être mélangées - Google Patents

Poche contenant deux substances séparées devant être mélangées Download PDF

Info

Publication number
EP0993819B1
EP0993819B1 EP99120421A EP99120421A EP0993819B1 EP 0993819 B1 EP0993819 B1 EP 0993819B1 EP 99120421 A EP99120421 A EP 99120421A EP 99120421 A EP99120421 A EP 99120421A EP 0993819 B1 EP0993819 B1 EP 0993819B1
Authority
EP
European Patent Office
Prior art keywords
substance
pouch
bag
abutment
support
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.)
Expired - Lifetime
Application number
EP99120421A
Other languages
German (de)
English (en)
Other versions
EP0993819A3 (fr
EP0993819A2 (fr
Inventor
Helmut Mader
Michael Krause
Horst Dr. Schwietz
Franz Dr. Fritzmeier
Karlheinz Baumann
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Nutrichem Diaet and Pharma GmbH
Original Assignee
Nutrichem Diaet and Pharma GmbH
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Nutrichem Diaet and Pharma GmbH filed Critical Nutrichem Diaet and Pharma GmbH
Publication of EP0993819A2 publication Critical patent/EP0993819A2/fr
Publication of EP0993819A3 publication Critical patent/EP0993819A3/fr
Application granted granted Critical
Publication of EP0993819B1 publication Critical patent/EP0993819B1/fr
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

Links

Images

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS 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
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2089Containers or vials which are to be joined to each other in order to mix their contents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS 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
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2093Containers having several compartments for products to be mixed
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65DCONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D81/00Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents
    • B65D81/32Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents for packaging two or more different materials which must be maintained separate prior to use in admixture
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B67OPENING, CLOSING OR CLEANING BOTTLES, JARS OR SIMILAR CONTAINERS; LIQUID HANDLING
    • B67BAPPLYING CLOSURE MEMBERS TO BOTTLES JARS, OR SIMILAR CONTAINERS; OPENING CLOSED CONTAINERS
    • B67B7/00Hand- or power-operated devices for opening closed containers
    • B67B7/24Hole-piercing devices
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS 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
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/10Bag-type containers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS 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
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/1475Inlet or outlet ports
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS 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
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2006Piercing means
    • A61J1/201Piercing means having one piercing end
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS 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
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/202Separating means
    • A61J1/2027Separating means having frangible parts
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10STECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S604/00Surgery
    • Y10S604/903Medical container with material agitation means

Definitions

  • the invention relates to a bag for holding a particular one in human or animal body to be introduced first substance with at least one on all sides enclosed sheath and one attached or to be attached to the sheath Piercing device, the piercing device having a displaceably mounted mandrel for pushing through the at least one shell and an abutment into which the Immerse the mandrel when it gets through the casing.
  • Such bags which can be filled with a nutrient, for example, are made of known from DE 196 00 530.
  • a special feature of the known bags is to be seen in the fact that a first substance is sealed by a shell enclosed on all sides against the outside world. In the application case is by means of a Pierce the piercing device attached to at least one envelope so that the Substance can be emptied or empties itself due to gravity. Across from previously used glass ampoules, the bags have the advantage that when emptied no ambient air is sucked in and the substance can be emptied germ-free.
  • the object of the present invention is to provide a bag that is essential is more universally applicable and in particular adding, i.e. loosening, Suspending or mixing substances allowed immediately before use.
  • a key concept of the present invention is to be seen in the fact that in one of the Abutment provided abutment a second substance is added, compared to the interior of the bag or the first substance through a separating film is separated.
  • the separating film can also be used with the piercing device perforate the first and second substance so that when the piercing device is actuated a mixing process between the first and the second substance is started.
  • the second substance can in particular be in liquid, solid, powdery, gaseous or gel form Condition.
  • the first and second In principle, substance can also be the same, so that replenishment via the abutment by connecting a filling system or additional bags in the actual ones for emptying provided bag can be supplied. Will over the abutment connected second bag and lie first and second substance in the liquid state with comparable viscosity, this results in the specifically examined bag Surprisingly, a mixing ratio between the first and second substance in the Ratio 50 to 50.
  • the first substance can be tapped into Bag second substances are supplied, which only have a short shelf life in the first substance are or decay relatively quickly in the first substance. Examples of such second substances are living microbiological cultures or sensitive substances like Glutamine or enzymes.
  • An essential core idea of the invention is that between the first and second Detect substance-drawn release film, which is simultaneously with piercing the bag is perforated.
  • the separating film is through the envelope of the bag self-formed, so that there is no need to produce and attach a separate separating film can.
  • the abutment is only towards the inside of the bag open towards, but covered with the release film and otherwise closed on all sides.
  • the second substance can be produced and Composition of the bag or attaching the piercing device to the envelope of the Be introduced bag.
  • second substances suitable, which is also durable by itself without contact with the first substance are, before using the bag a mixture between the first and second Substance is desired.
  • the abutment is preferably for receiving a film with a perforable film provided active ingredient single pack.
  • a pot-shaped abutment in particular can, for example, the receiving space for one enclosed with a film Form the tablet. If the perforable film is pierced, the one in the bag can be pierced first substance come into contact with the tablet, so that by mixing the first substance and the second substance (here the tablet) a desired effect is caused, or the second substance is extracted.
  • the piercing device can be provided with means to prevent the fluid substance from flowing into the abutment favor. This can be achieved in particular in that the piercing device has a mandrel with cutting ribs, the cutting ribs the fluid into the abutment initiate.
  • the abutment can also have a further opening, preferably at its End of bag facing.
  • This opening can be covered by a protective cover or a protective film can be closed.
  • the protective film can then be a second or additional bag or a substance cartridge can be connected or the fluid can be drained off.
  • the first step is to connect additional bags or bag systems or refill devices To be received.
  • the first substance to be emptied is diluted in the bag.
  • very constant mixing ratio of 50 to 50 This could be done both via density measurements as well as reproducibly checked using chloride ion determinations.
  • a substance cartridge on the abutment be connected.
  • food can be administered be thought, with special substances, additives, medicine in the substance cartridges etc. can be included.
  • a bag according to the proposed design it becomes possible to use a first substance as a basic substance depending on the specific The patient needs a suitable substance cartridge prescribed by the doctor admix.
  • possible configurations for the substance cartridge which can be connected to the bag largely aseptically, will continue to the specific embodiments described below.
  • the substance cartridge is either on the abutment can be pushed on or pushed into the abutment, with a seal between Substance cartridge and abutment by at least one peripheral projection between Substance cartridge and abutment is guaranteed.
  • the volume of the substance cartridge can be adapted to the volume of the abutment. To enlarge the The filling volume of the substance cartridge can, however, be extended to the outside his. In a concrete embodiment, this extension is in the best possible shape a second bag that can be connected directly.
  • both the substance cartridge and the abutment have a circumferential projection have, so they can with a corresponding design when pushing in or pushing in the substance cartridge first pass so that this already provides mechanical locking.
  • the all-round protrusions or the protective cartridge and the abutment itself are each designed to be elastic, that despite this locking option, an adequate seal between Substance cartridge and abutment is guaranteed.
  • the abutment on the side facing away from the bag Side also be formed on a drain connection. It can then go through the abutment substance can be added or removed directly from the bag. This idea will regardless of the idea of adding a second substance or mixing claimed a first and a second substance.
  • the piercing device also has, in particular the actuating piston of the piercing device has a connection for connection a connection or drain line. To this end, is between Actuating piston and mandrel provided a fluid passage so that substance over the Mandrel can be inserted into the bag or removed from the bag. This thought too becomes independent of the introduction of a second substance and independent of claimed the formation of a drain port on the abutment. If both Connections are provided on the actuating piston as well as on the abutment a bag in a simple way an inlet and outlet are provided.
  • 1a to 1d is a first embodiment of the bag with one in the abutment located second substance 51 shown.
  • 1a to 1d show the piercing device in different positions to illustrate how they work.
  • a piercing device 12 is on the outer Sleeve 11 of a bag 15 is welded on.
  • a further inner shell 27 which is enclosed on all sides and in which a first substance 50 is germ-free is packed.
  • the piercing device 12 comprises a circuit board 30 on which a front plate 31 and a rear plate 32 are formed. Between the front plate 31 and the rear Plate 32 forms the circuit board 30. Foil hinge 39 out.
  • the front plate 31 of the Circuit board 30 is on a first side of sleeve 11 and rear plate 32 on an opposite side Side of the sleeve 11 of the bag 15 welded. Through the foil hinge 39, front plate 31 and rear plate 32 of the board can be pressed together approach the assigned bag corner or bag edge.
  • a mandrel 13 of the piercing device 12 is essentially in the area of the front plate 31 vertical to the plane of the front plate 31 in a cylindrical guide 28 slidably mounted.
  • An actuating piston 29 is located on the end of the mandrel 13 Actuation of the mandrel 13. Actuating pistons 29 and mandrel 13 are opposite the cylindrical one Guide 28 is sealed, so that both the leakage of substance the bag 15 and the entry of germs into the bag 15 is prevented.
  • an abutment 14 is formed, into which the mandrel 13 can be immersed when the piercing device 12 is actuated.
  • the abutment 14 housed the second substance 51, the opposite the interior of the bag 15 is sealed off with a separating film 16.
  • the front plate 31 and the rear plate are first Plate 32 of the board 30, for example, in that actuating piston 29 and abutment 14 between the thumb and forefinger are pressed together.
  • the abutment 14 is thereby directly opposite placed the mandrel 13.
  • the mandrel 13 passes through the front side of the sleeve 11, twice through the inner envelope 27 and again through the envelope 11 and perforates this.
  • the outer shell 11 on the front and / or Corresponding recesses can also already be provided on the back, so that a perforation the outer shell 11 is not required.
  • the mandrel 13 After perforating the shell (s) of the Bag 15, the mandrel 13 also cuts a separating film 16 according to the invention, which Abutment 14 is covered and a second substance 51 is sealed off from the inside of bag 15.
  • the second substance 51 can with the im Mix bags of packaged first substance 50.
  • the first substance 50 also does not arrive until the inner shell 27 is perforated in the area between the inner sleeve 27 and outer sleeve 11 of the bag 15.
  • the result is at Another advantage of the specifically illustrated double bag.
  • the fluid first substance 50 flows out through the inner Shell 27 delimited inner bag in the area between inner shell 27 and outer Cover 11 out. This outflow occurs in part over the area of the mandrel 13 Piercing.
  • the mandrel 13 has crossed, substantially parallel cutting ribs 17 extending to the piercing direction.
  • the cutting ribs 17 guide the fluid first substance 50 in the area of the abutment 14, so that one located there second substance 51 is literally rinsed out after perforation of the release film 16 and mixes surprisingly homogeneously with the first substance 50.
  • the second substance 51 is in powder form or in the form of a tablet, is the one described above "Rinse out" extremely helpful.
  • the piercing device 12 is described below with reference to FIGS. 2a and 2b explained in more detail.
  • the circuit board 30 is shown in the opened state.
  • On the rear plate 32 is the abutment formed in one piece with the board 30 14 arranged.
  • On the opposite side is at the appropriate place on the front plate 31, the cylindrical guide 28 also integrally with the board 30 (/ U educated.
  • the cylindrical guide 28 has two guide ribs 33, which with corresponding Grooves 34 in the actuating piston 29 correspond.
  • a drain connection 35 is formed on the front plate 31, which has an outer nozzle 37 and concentrically with an inner nozzle 36.
  • the inner socket 36 is a pipe socket for discharging the first packaged in the bag and second substance 50, 51 are provided.
  • the outer socket 37 has an internal thread 38 on, so that a drain line 46 is preferably via a Luer connection can be connected.
  • Between the front plate 31 and rear plate 32 is on the Board 30 formed the previously mentioned film hinge 39, which is a much smaller Thickness than the front and rear plate 31, 32 has. Front plate 31 and rear plate 32 are further enclosed by film edges 52, 53. Over the foil edges 52, 53, the board 30 can be welded to the outer casing 11 of the bag 15.
  • Fig. 2b the piercing device II b, II b is shown in Fig. 2a.
  • the guide ribs 33 do not extend over the entire length of the cylindrical Guide 28 extend so that the actuating piston 29 in its starting and rest position relative to the cylindrical. Guide 28 can twist. Only if the grooves 34 provided in the actuating piston correspond to the guide ribs 33, the actuating piston 29 and thus the mandrel 13 can be pressed in, so that inadvertent perforation of the bag is made difficult.
  • a latching between the cylindrical guide 28 and the actuating piston 29 is effective such that the actuating piston 29 against falling from the cylindrical Guide 28 is secured.
  • Fig. 3a is the specific arrangement between the cylindrical guide 28 and the Actuating piston 29 and the mandrel 13 shown in a sectional view.
  • the actuating piston 29 has a central, central recess 54 which extends into the cylindrical one Guide 28 dips and slides along the inside of the cylindrical guide 28. Between the recess 54 of the actuating piston 29 and the cylindrical guide 28 A circumferential seal is effective to prevent substance from escaping from the bag 15 or the entry of germs or contaminants in the bag 15 prevented.
  • the mandrel 13 is arranged inside the actuating piston 29, below the recess 54, which has two cutting ribs 17 which run crosswise to one another.
  • 3b is a sectional view of the cylindrical guide 28 and the actuating piston 29 along the line III b, III b in Fig. 3a.
  • the guide ribs 33 of the cylindrical guide 28 correspond to the grooves 54 of the actuating piston 29 so that the mandrel 13 is displaced in the piercing device can be.
  • Fig. 3c is a sectional view of the slidably mounted in the cylindrical guide 28 Dorns 13 shown.
  • Guide ribs 33 can be the orientation of the actuating piston 29 and thus the Fix the mandrel 13 with its cutting ribs 17 so that for the perforation of the casing (s) and the separating film 16 and always reproducible for the inflow of the first substance 50 Conditions are created.
  • Fig. 3d is the drain port 35 of Fig. 2a in a sectional view along the Line III d, III d shown. That which is arranged in the outer connecting piece 37 can be clearly seen Internal thread 38.
  • the inner socket 36 is longer than the outer socket 37 formed and protrudes on the end facing away from the front plate 31.
  • FIG. 4a and 4b is an embodiment of a mountable on the abutment 14 Substance cartridge 20 shown.
  • the abutment 14 at its end facing away from your bag 15 an opening 21.
  • the opening 21 is lockable with a protective cover.
  • the protective cover could for example be designed as a removable cover, but preferably a protective film 23 is provided, which closes the opening 21 aseptically.
  • the substance cartridge 20 comprises an inner chamber 61, in which the second substance 51 is enclosed.
  • the substance cartridge 20 becomes outside delimited by a hat-shaped cap 58, inside which the chamber 61 is arranged is.
  • the chamber 61 is delimited by a wall 59, part of the inside of the hat-shaped cap 58 and a protective film 18.
  • the protective film 18 closes the second Substance 51 and protects against contamination and germs. When putting on the Protective cartridge 20 on the abutment 14, this protective film 18 is also cut.
  • a mandrel 41 a For perforating the protective film 18 of the substance cartridge 20 and the protective film 23 of the Abutment 14 is a mandrel 41 a within the chamber 61 of the substance cartridge 20 centrally arranged, the tip of which is slightly at rest from the protective film 18 the substance cartridge 20 is spaced.
  • the protective film 18 is slightly inwards and finally pressed on the mandrel 41 a, so that the protective film 18 is cut.
  • the now exposed mandrel 41a acts on the protective film 23 of the abutment 14 and also cuts them so that the chamber already inserted into the abutment 14 61 allows a germ-free transition of the second substance 51 into the abutment 14.
  • the chamber 61 has a corresponding one to the inner cross section of the abutment 14 Outside cross-section, which is dimensioned slightly smaller, so that the Can insert chamber 61 into the abutment 14.
  • Chamber 61 and abutment 14 can a substantially circular cross-section, an oval, rectangular or have a cross-section of another shape.
  • the inside cross section of the hat-shaped cap 58 can also be on the outside cross section of the abutment can be adapted in a corresponding manner.
  • Seals are preferably between the inner wall of the abutment 14 and the Chamber 61 provided.
  • the seals are advantageously arranged so that they happen when they are pushed open and the chamber 61 or the substance cartridge 20 is ensured on the abutment 14.
  • 5a to 5e is a third alternative embodiment of a substance cartridge 20 shown for coupling to the abutment 14. It is different from that in FIGS. 4a and 4b here the substance cartridge 20 is designed for insertion into the abutment 14.
  • the abutment 14 is open at both ends and thereby towards the inside of the bag with a separating film 16 and on the bag 15 opposite end covered with a protective film 23.
  • the substance cartridge 20 has a corresponding to the inner cross section of the abutment 14 External cross section on.
  • the substance cartridge 20 can have a circular, have an oval, rectangular cross section or cross section of another shape.
  • the Substance cartridge 20 itself is on its front side in the insertion direction a protective film 18 covered.
  • the protective film becomes when the substance cartridge 20 is inserted 23 of the abutment 14 perforated.
  • the substance cartridge has 20 and the abutment 14 on the surfaces facing each other circumferential seals on the leakage of the substance of the bag 15 or Prevent substance cartridge 20 or the entry of germs into the abutment 14.
  • the Seals are also advantageously designed so that they are Pass in and thus latch the substance cartridge 20 in the abutment 14 is guaranteed.
  • 5c, 5d and 5e explain the actuation of the piercing device 12 when inserted Substance cartridge 20.
  • the mandrel 13 of the piercing device 12 can this embodiment, in addition to the perforation of the sleeves 11 and 27, the release film 16 on the abutment 14 and the protective film 18 of the substance cartridge, see above that the second substance 51 located in the substance cartridge 20 into the interior of the Bag 15 arrive and mix there with the first substance 50.
  • an intermediate piece 40 is shown in a schematic diagram.
  • the intermediate piece 40 can be connected to the abutment 14 for emptying or filling the prey 15 become.
  • the intermediate piece 40 has at its for connection to the abutment 14 provided end an adapter 55, which is similar to that in FIGS. 4a and 4b shown substance cartridge 20 can be pushed onto the abutment 14.
  • adapter 55 is covered at the end with a protective film 18.
  • a mandrel 41b Within the Adapter 55 and covered by the protective film 18, there is a mandrel 41b which when pressing the adapter 55 onto the abutment 14, both the protective film 18 of the Adapters and the protective film 23 of the abutment 14 is severed.
  • a further connection can be made on the intermediate piece 40 22 may be provided, which corresponds here to the drain connection shown in FIG. 3d 35 is formed.
  • a connecting line 47 which can be designed as a straight connecting line with a uniform cross section.
  • an extension 42 is provided in the connecting line 47, in which a predetermined amount of second substance 51 is accommodated.
  • FIG. 7 shows an embodiment in which a plurality of additional bags 43, 44, 45 are connected in series to the abutment 14 of the bag 15.
  • a plurality of additional bags 43, 44, 45 are connected in series to the abutment 14 of the bag 15.
  • the intermediate piece 40 explained with reference to FIG. 6, in which the for receiving the second substance 51 provided extension 52 need not be provided, lets an additional bag 43 with its drain port 35 on the abutment 14 of the Connect bag 15.
  • the extra bags 43, 44, 45 can be provided as a "refill" for the bag 15. It is also possible to dilute the first substance 50 in an additional bag 43 Bag 15 effect.
  • the additional bags 43, 44, 45 can be emptied simultaneously, at different times or in succession.
  • Fig. 7 arrangement is purely schematic and is intended to be connected in series illustrate a plurality of bags, the majority of the bags being horizontal, vertical to one another or can be arranged in any other position.
  • FIG. 8a and 8b is an alternative embodiment of a circuit board with piercing device 12 shown.
  • the drain port 35 directly on the side facing away from the board 30 to the abutment 14 molded. This allows the bag 15 substance over the abutment supplied or removed from the bag 15.
  • the circuit board according to this modified embodiment can be smaller than in the embodiment 2a, since the drain port 35 is not separate must be arranged, but is integrally formed on the abutment 14.
  • the emptying level at the level of the piercing device 13 so that under Complete emptying is not possible under certain circumstances.
  • the board 30 can Piercing device 12, abutment 14 and drain port 35 much easier be formed.
  • FIG. 8c shows a partial sectional view of the piercing device 13, which is opposite the embodiment shown in Fig. 3a is modified.
  • Actuating piston 29 of the embodiment according to FIG. 3a is here between the actuating piston 29 and the mandrel 13 a fluid passage 56 formed so that after piercing the bag 15 by means of the mandrel 13 substance from the bag 15 into the interior of the Actuate the actuating piston 29 or inside the actuating piston 29 in the bag 15 can.
  • the recess 54 defines together with the internal thread 69 in this embodiment, a connection 57 for connecting additional bags 43, 44, 45 via connecting lines 47, 48, 49 or for connecting an emptying line 46th
  • the idea of the abutment 14 with an emptying connection 35 and / or the provision of a fluid passage 56 in the actuating piston 29 is claimed as essential to the invention regardless of the introduction of a second substance.
  • the bag system shown in FIG. 7 is characterized by a high-quality bag 15, which allows a visual control option if a transparent cover 11 is provided, and from additional bags 43, 44, 45. Allow the additional bags 43, 44, 45 numerous other possible applications (mixing, staggered, completely timed spaced delivery of substance, etc.) and are also much easier constructed, both with regard to the bags 43, 44, 45 and the circuit board 30.

Claims (10)

  1. Poche de réception d'une première substance à introduire notamment dans le corps de l'homme ou de l'animal, avec au moins une enveloppe (11) fermée tout autour et un dispositif à percer (12) fixé à l'enveloppe (11), où le dispositif à percer (12) présente une broche (13) logée d'une manière déplaçable pour le perçage d'au moins une enveloppe (11) et une butée (14) dans laquelle plonge la broche (13) lors du perçage de l'enveloppe (11), caractérisé :
    en ce qu'il est reçu dans la butée (14) une seconde substance qui est séparée de l'espace intérieur de la poche (15) respectivement de la première substance par une feuille de séparation (16)
    et où avec le dispositif à percer (12), également la feuille de séparation (16) entre la première et la seconde substance peut être perforée,
    de façon que lors de l'actionnement du dispositif à percer (12), une opération de mélange entre la première substance et la seconde substance est mise en marche.
  2. Poche selon la revendication 1, caractérisée en ce que la feuille de séparation (16) est formée par la gaíne (11) de la poche (15).
  3. Poche selon l'une des revendications 1 à 2, caractérisée
    en ce que la butée (14) est ouverte seulement vers l'intérieur de la poche (15), qu'elle est réalisée cependant de façon à être couverte par la feuille de séparation (16) et sinon à être fermée de tous côtés,
    où la seconde substance, lors de l'actionnement du dispositif à percer (12), peut sortir dans l'espace intérieur de la poche (15).
  4. Poche selon l'une des revendications 1 à 3, caractérisée en ce qu'un paquet individuel de matière active pourvue d'une feuille apte à être perforée est reçu dans la butée.
  5. Poche selon l'une des revendications 1 à 4, caractérisée en ce que la broche (13) présente des nervures de coupe (17) pour séparer l'enveloppe (11) et/ou la feuille de séparation (16), où les nervures de coupe (17) sont réalisées de préférence de façon qu'elles favorisent un afflux d'un fluide, en tant que première substance, dans la butée (14).
  6. Poche selon l'une des revendications précédentes, caractérisée en ce que la butée (14) présente à son extrémité éloignée de la poche (15) une ouverture (21) qui peut être fermée par un recouvrement de protection, où peuvent être raccordées à l'ouverture (21) une deuxième poche ou poche supplémentaire comme poche additionnelle (43, 44, 45) ou une cartouche de substance (20).
  7. Poche selon l'une des revendications 1 à 5, caractérisée en ce que la butée (14) présente à son extrémité éloignée de la poche (15) une feuille de protection (23) qui peut être perforée pour introduire une cartouche de substance (20) qui contient une seconde substance prédéterminée.
  8. Poche selon la revendication 7, caractérisée en ce que
    la cartouche de substance (20) peut être poussée sur la butée (14) ou poussée dans la butée (14),
    où une étanchéité est réalisée par une saillie s'étendant tout autour à la cartouche de substance (20) et/ou à la butée (14).
  9. Poche selon le préambule de la revendication 1 ou l'une des revendications 1 à 8, caractérisée en ce qu'un raccord de vidage (35) est rapporté par formage sur la butée (14).
  10. Poche selon l'une des revendications précédentes, caractérisée en ce que le dispositif à percer (12) comprend un piston d'actionnement (29) pour actionner la broche (13), où le piston d'actionnement (29) comprend un passage de fluide (56) et un raccord (57) pour un conduit de liaison (47, 48, 49) ou un conduit de vidage (46).
EP99120421A 1998-10-15 1999-10-14 Poche contenant deux substances séparées devant être mélangées Expired - Lifetime EP0993819B1 (fr)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
DE19847594 1998-10-15
DE19847594A DE19847594C1 (de) 1998-10-15 1998-10-15 Beutel zur Aufnahme einer insbesondere in den menschlichen oder tierischen Körper einzubringenden ersten Substanz
US09/452,300 US6659994B1 (en) 1998-10-15 1999-12-01 Bag for storing a first substance injectable, in particular, in a human or animal body
JP35418999A JP3995853B2 (ja) 1998-10-15 1999-12-14 特に人間又は動物の身体内に取り入れるための第1の物質を収容するためのバッグ
CA002293919A CA2293919A1 (fr) 1998-10-15 1999-12-31 Sac pour placer une premiere substance a injecter, en particulier, dans le corps d'un etre humain ou d'un animal

Publications (3)

Publication Number Publication Date
EP0993819A2 EP0993819A2 (fr) 2000-04-19
EP0993819A3 EP0993819A3 (fr) 2000-11-02
EP0993819B1 true EP0993819B1 (fr) 2002-12-11

Family

ID=32110861

Family Applications (1)

Application Number Title Priority Date Filing Date
EP99120421A Expired - Lifetime EP0993819B1 (fr) 1998-10-15 1999-10-14 Poche contenant deux substances séparées devant être mélangées

Country Status (7)

Country Link
US (1) US6659994B1 (fr)
EP (1) EP0993819B1 (fr)
JP (1) JP3995853B2 (fr)
AT (1) ATE229312T1 (fr)
CA (1) CA2293919A1 (fr)
DE (2) DE19847594C1 (fr)
ES (1) ES2185287T3 (fr)

Families Citing this family (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE19847594C1 (de) * 1998-10-15 2000-06-08 Nutrichem Diaet & Pharma Gmbh Beutel zur Aufnahme einer insbesondere in den menschlichen oder tierischen Körper einzubringenden ersten Substanz
EP1219282A1 (fr) * 2000-12-21 2002-07-03 Nutrichem Diät + Pharma GmbH Tubulure de raccordement d'un sac destiné à l'administration de substances au corps humain ou animal
WO2005034861A2 (fr) * 2003-10-02 2005-04-21 The Bio Balance Corporation Composition biotherapeutique sechee, ses utilisations et son dispositif et ses procedes d'administration
US9364215B2 (en) 2006-01-26 2016-06-14 Covidien Lp Medical device package
CA2604433A1 (fr) * 2006-10-06 2008-04-06 Tyco Healthcare Group Lp Emballage de dispositif medical comprenant un orifice auto- perforable
CA2676237A1 (fr) * 2007-03-05 2008-09-12 Tyco Healthcare Group Lp Appareil pour acceder a un conditionnement medical
US20090008417A1 (en) * 2007-07-05 2009-01-08 Gunn Jonathan R Attachable spout for affixation to pouch-like container of liquid
CH699115A1 (de) * 2008-07-14 2010-01-15 Medmix Systems Ag Austraganordnung mit einer Kartusche mit Beutel.
EP2630075A4 (fr) 2010-10-22 2015-04-08 Py Daniel C Connecteur de poche et procédé apparenté
AU2013318607C1 (en) 2012-09-21 2017-07-13 Wilton Industries, Inc. Coupler for decorating bag
US9579686B2 (en) 2012-10-29 2017-02-28 Nordson Corporation Fluid dispensing assemblies and methods of dispensing fluids from containers
US10426701B2 (en) 2016-01-19 2019-10-01 Medinstill Development Llc Single use connectors
US11591200B2 (en) * 2020-09-14 2023-02-28 Christopher Robles Package opener, dispenser, and related methods

Family Cites Families (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4515586A (en) * 1982-11-30 1985-05-07 Abbott Laboratories Powder syringe mixing system
US4548606A (en) * 1983-09-29 1985-10-22 Abbott Laboratories Dual compartmented container with activating means
US4601704A (en) * 1983-10-27 1986-07-22 Abbott Laboratories Container mixing system with externally mounted drug container
US4609369A (en) * 1985-02-08 1986-09-02 John Fontana Intravenous solution administration apparatus and method
US5114421A (en) * 1986-09-22 1992-05-19 Polak Robert B Medicament container/dispenser assembly
DE69111480T2 (de) * 1990-02-14 1996-03-14 Shinsozai Sogo Kenkyusho Kk Gefüllter und abgedichteter, unabhängiger Mischbehälter.
DE19655056C2 (de) * 1996-01-10 2001-03-01 Nutrichem Diaet & Pharma Gmbh Beutel zur Aufnahme mindestens einer Flüssigkeit und flüssigkeitsgefüllter Beutel
DE19751489A1 (de) * 1997-11-20 1999-05-27 Nutrichem Diaet & Pharma Gmbh Doppelbeutel zur Applikation einer fluiden Substanz
DE19847594C1 (de) * 1998-10-15 2000-06-08 Nutrichem Diaet & Pharma Gmbh Beutel zur Aufnahme einer insbesondere in den menschlichen oder tierischen Körper einzubringenden ersten Substanz

Also Published As

Publication number Publication date
DE59903726D1 (de) 2003-01-23
EP0993819A3 (fr) 2000-11-02
JP2001170135A (ja) 2001-06-26
ES2185287T3 (es) 2003-04-16
DE19847594C1 (de) 2000-06-08
CA2293919A1 (fr) 2001-06-30
US6659994B1 (en) 2003-12-09
EP0993819A2 (fr) 2000-04-19
ATE229312T1 (de) 2002-12-15
JP3995853B2 (ja) 2007-10-24

Similar Documents

Publication Publication Date Title
DE69626413T2 (de) Medizinisches ventil mit ringartiger dichtung
EP0531809B1 (fr) Dispositif implantable pour administrer des substances actives
DE69824018T2 (de) Aseptische anschlussvorrichtung
EP0993819B1 (fr) Poche contenant deux substances séparées devant être mélangées
EP1140259B1 (fr) Ampoule multichambre servant a distribuer un melange constitue de plusieurs substances
DE602004006442T2 (de) Zweikomponentenmisch- und -ausgabevorrichtung
DE69839128T2 (de) Spenderanordnung
EP2730332B1 (fr) Dispositif de mélange et d'extraction d'une masse pâteuse
EP2618759B1 (fr) Dispositif de mélange pour système de cimentation sous vide à pré-emballage, système de cimentation sous vide et procédé
DE19852557C2 (de) Verschlußelement
DE3627231C2 (de) Überleitungsgerät zum Mischen von in unterschiedlichen Behältern befindlichen Medikamenten
DE2824588A1 (de) Einweg-stopfen fuer vakuumroehrchen
DE2921768A1 (de) Sterile belueftungseinheit fuer medizinische geraete
DE2201141A1 (de) Probenbehaelter
EP0663348A1 (fr) Dispositif pour le vidage d'un sac tubulaire
DE102014112043A1 (de) Gespannte Öffnungsvorrichtung für Monomerbehälter
WO1990003775A1 (fr) Recipient pour la conservation separee et sterile d'au moins deux substances et pour leur melange
DE69723278T2 (de) Pharmazeutische ampulle
DE1491850B1 (de) Spritzampulle
DE2815377A1 (de) Vorrichtung zum sammeln von blut
EP2393597B1 (fr) Dispositif d'echantillonnage pour des liquides biologique
EP2764918A1 (fr) Dispositif d'analyse d'un liquide de test
WO2016020097A1 (fr) Dispositif de mélange, en particulier conçu pour le mélange de ciment osseux
DE4410875A1 (de) Medizinische Beutelanordnung
DE19842960C2 (de) Vorrichtung zum Entnehmen von Flüssigkeiten aus medizinischen Behältern und einer Aufnahmeeinheit für Zusatzstoffe

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

Free format text: ORIGINAL CODE: 0009012

AK Designated contracting states

Kind code of ref document: A2

Designated state(s): AT BE CH CY DE DK ES FI FR GB GR IE IT LI LU MC NL PT SE

AX Request for extension of the european patent

Free format text: AL;LT;LV;MK;RO;SI

PUAL Search report despatched

Free format text: ORIGINAL CODE: 0009013

AK Designated contracting states

Kind code of ref document: A3

Designated state(s): AT BE CH CY DE DK ES FI FR GB GR IE IT LI LU MC NL PT SE

AX Request for extension of the european patent

Free format text: AL;LT;LV;MK;RO;SI

17P Request for examination filed

Effective date: 20010124

AKX Designation fees paid

Free format text: AT BE CH CY DE DK ES FI FR GB GR IE IT LI LU MC NL PT SE

AXX Extension fees paid

Free format text: AL PAYMENT 20010124;LT PAYMENT 20010124;LV PAYMENT 20010124;MK PAYMENT 20010124;RO PAYMENT 20010124;SI PAYMENT 20010124

17Q First examination report despatched

Effective date: 20011030

GRAG Despatch of communication of intention to grant

Free format text: ORIGINAL CODE: EPIDOS AGRA

GRAG Despatch of communication of intention to grant

Free format text: ORIGINAL CODE: EPIDOS AGRA

GRAH Despatch of communication of intention to grant a patent

Free format text: ORIGINAL CODE: EPIDOS IGRA

GRAH Despatch of communication of intention to grant a patent

Free format text: ORIGINAL CODE: EPIDOS IGRA

GRAA (expected) grant

Free format text: ORIGINAL CODE: 0009210

AK Designated contracting states

Kind code of ref document: B1

Designated state(s): AT BE CH CY DE DK ES FI FR GB GR IE IT LI LU MC NL PT SE

AX Request for extension of the european patent

Free format text: AL PAYMENT 20010124;LT PAYMENT 20010124;LV PAYMENT 20010124;MK PAYMENT 20010124;RO PAYMENT 20010124;SI PAYMENT 20010124

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: NL

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20021211

Ref country code: IE

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20021211

Ref country code: GR

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20021211

Ref country code: FI

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20021211

REF Corresponds to:

Ref document number: 229312

Country of ref document: AT

Date of ref document: 20021215

Kind code of ref document: T

REG Reference to a national code

Ref country code: GB

Ref legal event code: FG4D

Free format text: NOT ENGLISH

RIN1 Information on inventor provided before grant (corrected)

Inventor name: BAUMANN, KARLHEINZ

Inventor name: FRITZMEIER, FRANZ DR.

Inventor name: SCHWIETZ, HORST DR.

Inventor name: KRAUSE, MICHAEL

Inventor name: MADER, HELMUT

REG Reference to a national code

Ref country code: CH

Ref legal event code: EP

GBT Gb: translation of ep patent filed (gb section 77(6)(a)/1977)

Effective date: 20021211

REG Reference to a national code

Ref country code: IE

Ref legal event code: FG4D

Free format text: GERMAN

REF Corresponds to:

Ref document number: 59903726

Country of ref document: DE

Date of ref document: 20030123

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: SE

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20030311

Ref country code: PT

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20030311

Ref country code: DK

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20030311

REG Reference to a national code

Ref country code: ES

Ref legal event code: FG2A

Ref document number: 2185287

Country of ref document: ES

Kind code of ref document: T3

NLV1 Nl: lapsed or annulled due to failure to fulfill the requirements of art. 29p and 29m of the patents act
LTIE Lt: invalidation of european patent or patent extension

Effective date: 20021211

ET Fr: translation filed
REG Reference to a national code

Ref country code: IE

Ref legal event code: FD4D

Ref document number: 0993819E

Country of ref document: IE

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: LU

Free format text: LAPSE BECAUSE OF NON-PAYMENT OF DUE FEES

Effective date: 20031014

Ref country code: CY

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20031014

Ref country code: AT

Free format text: LAPSE BECAUSE OF NON-PAYMENT OF DUE FEES

Effective date: 20031014

PLBE No opposition filed within time limit

Free format text: ORIGINAL CODE: 0009261

STAA Information on the status of an ep patent application or granted ep patent

Free format text: STATUS: NO OPPOSITION FILED WITHIN TIME LIMIT

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: MC

Free format text: LAPSE BECAUSE OF NON-PAYMENT OF DUE FEES

Effective date: 20031031

Ref country code: LI

Free format text: LAPSE BECAUSE OF NON-PAYMENT OF DUE FEES

Effective date: 20031031

Ref country code: CH

Free format text: LAPSE BECAUSE OF NON-PAYMENT OF DUE FEES

Effective date: 20031031

Ref country code: BE

Free format text: LAPSE BECAUSE OF NON-PAYMENT OF DUE FEES

Effective date: 20031031

26N No opposition filed

Effective date: 20030912

BERE Be: lapsed

Owner name: *NUTRICHEM DIAT + PHARMA G.M.B.H.

Effective date: 20031031

REG Reference to a national code

Ref country code: CH

Ref legal event code: PL

PGFP Annual fee paid to national office [announced via postgrant information from national office to epo]

Ref country code: GB

Payment date: 20080930

Year of fee payment: 10

PGFP Annual fee paid to national office [announced via postgrant information from national office to epo]

Ref country code: ES

Payment date: 20081020

Year of fee payment: 10

PGFP Annual fee paid to national office [announced via postgrant information from national office to epo]

Ref country code: IT

Payment date: 20081016

Year of fee payment: 10

PGFP Annual fee paid to national office [announced via postgrant information from national office to epo]

Ref country code: FR

Payment date: 20081028

Year of fee payment: 10

PGFP Annual fee paid to national office [announced via postgrant information from national office to epo]

Ref country code: DE

Payment date: 20081229

Year of fee payment: 10

REG Reference to a national code

Ref country code: FR

Ref legal event code: ST

Effective date: 20100630

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: FR

Free format text: LAPSE BECAUSE OF NON-PAYMENT OF DUE FEES

Effective date: 20091102

Ref country code: DE

Free format text: LAPSE BECAUSE OF NON-PAYMENT OF DUE FEES

Effective date: 20100501

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: GB

Free format text: LAPSE BECAUSE OF NON-PAYMENT OF DUE FEES

Effective date: 20091014

REG Reference to a national code

Ref country code: ES

Ref legal event code: FD2A

Effective date: 20110308

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: IT

Free format text: LAPSE BECAUSE OF NON-PAYMENT OF DUE FEES

Effective date: 20091014

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: ES

Free format text: LAPSE BECAUSE OF NON-PAYMENT OF DUE FEES

Effective date: 20110307

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: ES

Free format text: LAPSE BECAUSE OF NON-PAYMENT OF DUE FEES

Effective date: 20091015