EP0737467A1 - Device for putting together a first liquid component and a second rigid or liquid component by means of vacuum under sterile conditions - Google Patents
Device for putting together a first liquid component and a second rigid or liquid component by means of vacuum under sterile conditions Download PDFInfo
- Publication number
- EP0737467A1 EP0737467A1 EP19960103858 EP96103858A EP0737467A1 EP 0737467 A1 EP0737467 A1 EP 0737467A1 EP 19960103858 EP19960103858 EP 19960103858 EP 96103858 A EP96103858 A EP 96103858A EP 0737467 A1 EP0737467 A1 EP 0737467A1
- Authority
- EP
- European Patent Office
- Prior art keywords
- hollow body
- cannula
- container
- guide
- wall
- 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.)
- Granted
Links
- 239000007788 liquid Substances 0.000 title claims description 15
- 230000035515 penetration Effects 0.000 claims abstract description 6
- 238000007789 sealing Methods 0.000 claims description 9
- 238000004806 packaging method and process Methods 0.000 claims description 8
- 238000006073 displacement reaction Methods 0.000 claims description 4
- 238000003780 insertion Methods 0.000 claims description 4
- 230000037431 insertion Effects 0.000 claims description 4
- 239000007787 solid Substances 0.000 claims description 3
- 238000012546 transfer Methods 0.000 description 18
- 238000013461 design Methods 0.000 description 9
- 238000013459 approach Methods 0.000 description 3
- 238000002347 injection Methods 0.000 description 3
- 239000007924 injection Substances 0.000 description 3
- 239000000126 substance Substances 0.000 description 3
- 239000004698 Polyethylene Substances 0.000 description 2
- 230000036512 infertility Effects 0.000 description 2
- 230000002427 irreversible effect Effects 0.000 description 2
- 238000004519 manufacturing process Methods 0.000 description 2
- 230000000149 penetrating effect Effects 0.000 description 2
- 238000002360 preparation method Methods 0.000 description 2
- IAYPIBMASNFSPL-UHFFFAOYSA-N Ethylene oxide Chemical compound C1CO1 IAYPIBMASNFSPL-UHFFFAOYSA-N 0.000 description 1
- 230000003213 activating effect Effects 0.000 description 1
- 239000011324 bead Substances 0.000 description 1
- 230000015572 biosynthetic process Effects 0.000 description 1
- 238000011161 development Methods 0.000 description 1
- 238000004090 dissolution Methods 0.000 description 1
- 238000009434 installation Methods 0.000 description 1
- 238000000034 method Methods 0.000 description 1
- 239000004033 plastic Substances 0.000 description 1
- 229920003023 plastic Polymers 0.000 description 1
- -1 polyethylene Polymers 0.000 description 1
- 229920000573 polyethylene Polymers 0.000 description 1
- 238000009517 secondary packaging Methods 0.000 description 1
Images
Classifications
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- 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
- A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
- A61J1/2089—Containers or vials which are to be joined to each other in order to mix their contents
-
- 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
-
- 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
- A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
- A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
- A61J1/2006—Piercing means
- A61J1/201—Piercing means having one piercing end
-
- 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
- A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
- A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
- A61J1/2006—Piercing means
- A61J1/2013—Piercing means having two piercing ends
-
- 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
- A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
- A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
- A61J1/2048—Connecting means
- A61J1/2065—Connecting means having aligning and guiding means
Definitions
- the invention relates to a device for bringing together a first liquid and a second solid or liquid component by means of negative pressure under sterile conditions, with a first container holding the first component and a second container holding the second component under pressure, and a cylindrical hollow body for holding the first container in the area of its closure in a first hollow body opening and a second hollow body opening arranged diametrically to this, for receiving the second container in the region of its closure, and at least one cannula mounted in the hollow body and displaceable in its longitudinal direction for piercing the respectively closing the containers Sealing plug, the cannula being mounted in a cannula holder.
- Such a device which forms part of a preassembled system for transferring liquids, is known from DE 38 17 101 A1.
- the system allows the second container with the attached device to be placed on the market, so that in order to transfer liquid into this second container, only the first container has to be attached to the unit formed by the second container and the device.
- the displaceable mounting of the cannula in the hollow body and a drive-over resistance protruding into the path of the cannula holder ensure that the second container inserted into the hollow body is connected to it but does not come into contact with the cannula.
- a circumferential projection is provided both on the cannula support and on a bearing sleeve forming part of the hollow body.
- the resistance resulting from the contact between the two projections for driving over the projection on the bearing sleeve side is greater than the penetration resistance of the cannula when penetrating into the sealing plug of the first container.
- the disadvantage here is that the formation of the parts with the projections requires an exact dimensioning of the outer projection diameter of the cannula holder and the inner projection diameter of the bearing sleeve in order to achieve the chronological puncturing of the sealing plugs of the containers.
- the projections also require an increased manufacturing outlay for the device, based on the manufacture of the cannula holder and the hollow body, and the rest of the assembly of the device in the area of the cannula holder is quite complex.
- the cannula carrier is designed as a plate-shaped body oriented perpendicular to the longitudinal direction of the hollow body, which is connected to the inner wall of the hollow body by means of retaining webs, the retaining webs being able to be torn by applying a manual force , which is greater than the penetration force of the cannula when piercing the sealing plug of the first container.
- the cannula holder is thus fixed to the inner wall of the hollow body by means of the plate-shaped retaining webs before the cannula is inserted into the sealing plug of the second container.
- a displacement of the cannula is therefore only possible if the holding bars were previously torn by applying the manual force. This ensures a safe sequential sequence of the movement.
- the design of the device enables its simple design by, as the case may be, down to the cannula Plastic injection molded part is designed.
- the cannula carrier is connected to guide projections which are directed towards the inner wall of the hollow body. After the holding webs have been separated, these enable the cannula holder to be guided largely without tilting relative to the inner wall of the hollow body, and thus a largely exact guidance of the cannula in the piercing area to the second container, the cannula also being held in the sealing plug of the first container.
- the hollow body advantageously has an opening with a circular cross section.
- a triangular or circular configuration of the cannula holder is appropriate.
- the cannula holder has, for example, the shape of an equilateral triangle, with three guide lugs which are connected to the cannula holder in the area of the center of the triangular sides of the cannula holder.
- four guide lugs are preferably connected to the circumference of the cannula carrier.
- the guide lugs can have radially outer concentric to the cannula and guide lugs extending in the longitudinal direction of the hollow body.
- a preferred development of the invention provides that guide projections extending in the longitudinal direction thereof are connected to the inner wall of the hollow body, between which the guide projections or the corners of the cannula holder are arranged.
- the respective guide approach should be connected to the cannula support via a central web and two guide approaches should engage behind the guide approach in the area of the central web.
- the design of the hollow body with guide lugs necessitates a defined positioning of the cannula carrier relative to the hollow body during its displacement in the longitudinal direction and also prevents relative rotation or tilting of the cannula carrier relative to the hollow body.
- the container in the hollow body it is advantageously extended in the area of at least one end parallel to the container to be received by the associated hollow body opening.
- the extension causes the container not only in the area of the plug having the container neck is held, but the extended portion of the hollow body also at least partially surrounds the generally enlarged, voluminous area of the container at a greater or lesser distance, so that tilting of the container in the hollow body is excluded.
- This is particularly important for the container that holds the substance under negative pressure or vacuum conditions, so that when the liquid is transferred into this container, it does not have to be actively carried out, but is only required for the other container that holds the liquid.
- the elongated section of the hollow body expediently has an inner diameter which is slightly larger than the outer diameter of the container. This not only prevents the container from accidentally tipping over, but also guides the container in a defined manner.
- the device with the two containers forms a preassembled, sterile packaged system, in which the two containers are kept out of contact with the cannula in the cylindrical hollow body and a packaging includes the containers and the hollow body in a sterile manner.
- a transfer system and packaging are available that significantly simplify, accelerate the preparation of the components in the containers, and allow preparation that is completely separate from the immediate use, as well as allow the reconstituted components to be stored for several days.
- the design and arrangement of the transfer system enables a quick, safe, confusion-free and irreversible transfer of the component located in the first container to the second container containing the other component with the least possible effort for the user and while maintaining sterility even after the components have been merged.
- Figure 1 shows a cylindrical hollow body 3, the two hollow body openings 6 and 7 have the same inner diameter.
- the upper hollow body opening 6, based on the orientation of FIG. 1, serves to hold a bottle 1 which holds a liquid
- the lower opening 7 serves to hold a bottle 2 which holds a substance under vacuum or vacuum conditions.
- the opening of the respective bottle 1 or 2 closes Rubber stopper, not shown, which is held by means of a crimp cap 4 or 5.
- the bottle 1 or 2 is inserted into the hollow body 3 and held by the latter.
- a plate-shaped cannula carrier 9 is arranged within the hollow body 3, which is positioned perpendicular to the central longitudinal axis 31 of the hollow body 3.
- the cannula support 9 is fixedly connected to the inner wall 30 of the hollow body 3 via a plurality of radially extending holding webs 13.
- the cannula holder 9 has a through hole for receiving a cannula 8, the through axis of which coincides with the central longitudinal axis 31.
- the bottle 2 After insertion into the hollow body 3, the bottle 2 contacts stops 10 connected to the inner wall 30 of the hollow body 3, so that it cannot be pushed further into the hollow body 3 in the direction of the cannula 8, but rather is clamped between the assigned inner wall section of the hollow body 3 .
- the liquid-absorbing bottle 1, on the other hand, is held in a preassembled position in a section of the hollow body 3 facing the actual hollow body opening area, an inner annular bead 33 oriented parallel to the cannula holder 9 projecting into the displacement path of the crimp cap 4 and thus defining the installation position. In the preassembled position shown in FIG.
- the transfer system is already sealed and sterilized in a peelable outer packaging 14 by the pharmaceutical manufacturer, as illustrated in FIG. 2.
- This outer packaging 14 consists of a thermoformed soft blister film, preferably PA / PE and a sterilizable, sealable medical paper or a polyethylene spunbond. After the labeled and assembled units have been sealed in, they are sterilized, for example with ethylene oxide. In an appropriately designed Secondary packaging, the user then prepares the components in the sterile outer packaging, while maintaining sterility despite piercing the respective containers.
- Figures 3a to 3c illustrate the processes to bring the components together.
- Figure 3a illustrates the pre-assembled system as shown in Figure 1. Proceeding from this, the liquid-absorbing bottle 1 is pushed further into the hollow body 3, the cannula 8 penetrating the sealing plug of the bottle 1, which is made of rubber. This is possible because the penetration or penetration force of the cannula 8 into or through the rubber stopper of the bottle 1 is less than the force required to pull the cannula holder 9 connected to the hollow body 3 via the holding webs 13 from the latter separate. In the advanced position of the bottle 1 shown in FIG.
- the crimp cap 4 of this bottle 1 comes into contact with the cannula holder 9, so that the push-in force manually exerted on the bottle 1 for pushing in the bottle 1 is transferred directly to the cannula support 9 in the hollow body 3.
- the retaining webs 13 tear, so that the bottle 1 together with the cannula holder 9 and thus the cannula 8 is displaced further in the direction of the bottle 2 within the hollow body 3, so that the cannula 8 pierces the rubber stopper of this bottle 2 .
- the negative pressure in the bottle 2 sucks the liquid from the bottle 1 into the bottle 2 and leads to the dissolution or mixing of the solid or liquid component contained therein.
- the system with the cannula 8 in the transfer position is shown in FIG. 3c.
- FIGS. 4a and 4b illustrate the device for merging the components described in FIGS. 1 to 3c for the transfer system in detail.
- the hollow body 3 is formed in the region of the hollow body opening 6 as a ring 34 with retaining webs 16 connected to one another only by thin points.
- bottles 1 of different volumes for example all injection bottles from 6 to 100 ml, since when activating bottle 1 with a nominal volume greater than or equal to 10 ml, insertion into hollow body 3 is only possible if it is initially used for fixation used ring is blown up and offers the larger body diameter of the bottle 1 place.
- the cannula carrier 9 essentially has the shape of a circle and is provided with four guide lugs 35 which are connected to the cannula carrier 9 at 90 ° relative to one another on the circumference thereof.
- the guide lugs 35 have a guide surface 36 which extends concentrically to the cannula 8 and extends in the longitudinal direction of the hollow body 3 radially on the outside. This is arranged at a short distance from the inner wall 30 of the hollow body 3, so that the cannula support 9 after the tearing of the holding webs 13 is free of play and thus can be moved in the hollow body 3 so that it cannot tip over.
- the hollow body 3 is provided on the inside with four ribs 37, which run in the longitudinal direction of the hollow body 3 and are each offset by 90 ° to one another, which define the receiving diameter of the hollow body 3 for the bottle 1 and thus ensure an exact positioning of the bottle 1, whereby the insertion of this bottle 1 because of its abutment with its crimp cap 4 on the ribs 37 can be carried out with little effort.
- the ribs 37 penetrate recesses 38 between the guide lugs 35.
- Reference numeral 15 denotes a holding web arranged in the plane of the stops 10 and connected to the interior of the hollow body 3, which, after the components have been reconstituted when the bottle 2 is pulled out of the hollow body 3, prevents the cannula carrier 9 from falling out of the hollow body 3 or the cannula 8 held in the cannula holder 9 gets stuck in the rubber stopper of the bottle 2.
- the cannula carrier 9 has essentially the shape of an equilateral triangle and three guide lugs 35 are provided which are connected to the cannula carrier 9 in the area of the center of the triangular sides of the cannula carrier 9.
- wing-like guide lugs 12 extending in the longitudinal direction thereof are connected, between which the guide lugs 35 of the cannula holder 9 are arranged.
- the respective guide projection 35 is connected to the cannula support 9 via a central web 39 and two adjacent guide projections 12 engage behind the guide projection 35 in the region of the central web 39.
- Each guide projection 35 is connected to the hollow body 3 via a holding web 13.
- the triangular dimension of the cannula carrier 9 is selected so that its tips are positioned with minimal play relative to the inner wall 30 of the hollow body 3, which otherwise also applies to the position of the guide surface 36 of the respective guide projection 35 and the inner wall 30 of the hollow body 3.
- Adjacent guide lugs 12 are arranged so as to diverge from the inner wall 30 that they accommodate a corner 40 of the cannula holder 9 between them.
- the crimp cap 4 of the bottle 1 is preassembled on the guide lugs 12 up to the recessed lugs 11 of the guide lugs 12.
- the guide lugs 12 become radially outward bent, the crimp cap 4 comes into contact with the cannula holder 9 and the retaining webs 13 are blown up when an increased manual force is applied.
- the hollow body opening 7 has a greater longitudinal extent (compared to the embodiment according to FIG. 6a). This is achieved by an extension of the ring section 45 of the hollow body 3 forming the opening.
- the inside diameter of the ring section is dimensioned slightly larger than the outside diameter of the bottle 2 in the bottle section 46.
- Figure 7 illustrates that the outer diameter of the crimp cap 5 is smaller than the outer diameter of the container 2 and the ring portion 45 extends to the side of the flange portion 46. This effectively prevents the bottle 2 from tilting in the hollow body opening 7.
- the upper hollow body opening 6 is designed accordingly, that is to say that the bottle 1 is also guided there in the area of its bottle section 46, and thus its maximum expanded area.
- the transfer device according to FIGS. 4a and 4b is suitable for injection bottles 1 and 2 with a nominal size of 20 mm.
- the transfer device according to FIGS. 5a and 5b serves to transfer a substance from a bottle 1 with a nominal size of 13 mm into a bottle 2 with a nominal size of 20 mm.
- the device serves to hold bottles 1 and 2 with a nominal size of 13 mm.
- the embodiment according to FIGS. 7a and 7b also serves to hold bottles 1 and 2 with a nominal size of 13 mm.
Abstract
Description
Die Erfindung betrifft eine Vorrichtung zum Zusammenführen einer ersten flüssigen und einer zweiten festen oder flüssigen Komponente mittels Unterdruck unter sterilen Bedingungen, mit einem die erste Komponente aufnehmenden ersten Behältnis und einem die zweite Komponente aufnehmenden, unter Unterdruck stehenden zweiten Behältnis, sowie einem zylindrischen Hohlkörper zur Aufnahme des ersten Behältnisses im Bereich dessen Verschlusses in einer ersten Hohlkörperöffnung und einer zweiten, diametral zu dieser angeordneten Hohlkörperöffnung, zur Aufnahme des zweiten Behältnisses im Bereich dessen Verschlusses, sowie mindestens einer im Hohlkörper gelagerten und in dessen Längsrichtung verschiebbaren Kanüle zum Durchstechen der die Behältnisse jeweils verschließenden Verschlußstopfen, wobei die Kanüle in einem Kanülenträger gelagert ist.The invention relates to a device for bringing together a first liquid and a second solid or liquid component by means of negative pressure under sterile conditions, with a first container holding the first component and a second container holding the second component under pressure, and a cylindrical hollow body for holding the first container in the area of its closure in a first hollow body opening and a second hollow body opening arranged diametrically to this, for receiving the second container in the region of its closure, and at least one cannula mounted in the hollow body and displaceable in its longitudinal direction for piercing the respectively closing the containers Sealing plug, the cannula being mounted in a cannula holder.
Eine derartige Vorrichtung, die Bestandteil eines vormontierten Systems zur Überleitung von Flüssigkeiten bildet, ist aus der DE 38 17 101 A1 bekannt. Das System erlaubt es, das zweite Behältnis mit der aufgesteckten Vorrichtung in den Handel zu bringen, so daß zum Überleiten von Flüssigkeit in dieses zweite Behältnis nur noch das erste Behältnis auf die durch das zweite Behältnis und die Vorrichtung gebildete Einheit aufgesteckt werden muß. Die verschiebbare Lagerung der Kanüle im Hohlkörper und ein in den Weg des Kanülenträgers ragender Überfahrwiderstand stellen sicher, daß das in den Hohlkörper eingesetzte zweite Behältnis zwar mit diesem verbunden ist, aber nicht in Kontakt mit der Kanüle gelangt. Erst nach dem Anstechen des die Flüssigkeit aufnehmenden ersten Behältnisses wird beim weiteren Einführen des Behälterstutzens des ersten Behältnisses der Überfahrwiderstand überfahren und der Verschlußstopfen des zweiten Behältnisses durchstochen, womit das Innere der beiden Behältnisse mittels der Kanüle verbunden ist.Such a device, which forms part of a preassembled system for transferring liquids, is known from DE 38 17 101 A1. The system allows the second container with the attached device to be placed on the market, so that in order to transfer liquid into this second container, only the first container has to be attached to the unit formed by the second container and the device. The displaceable mounting of the cannula in the hollow body and a drive-over resistance protruding into the path of the cannula holder ensure that the second container inserted into the hollow body is connected to it but does not come into contact with the cannula. Only after the first container has been pierced with the liquid, when the container neck of the first container is inserted further, the overrun resistance is run over and the sealing plug of the second container is pierced, which means the interior of the two containers is connected by means of the cannula.
Bei der bekannten Vorrichtung ist sowohl am Kanülenträger als auch an einer Bestandteil des Hohlkörpers bildenden Lagerhülse ein umlaufender Vorsprung vorgesehen. Der beim Kontakt der beiden Vorsprünge sich ergebende Widerstand zum Überfahren des lagerhülsenseitigen Vorsprunges ist größer als der Durchdringwiderstand der Kanüle beim Eindringen in den Verschlußstopfen des ersten Behältnisses. Nachteilig ist hierbei, daß die Ausbildung der Teile mit den Vorsprüngen eine exakte Bemessung von Vorsprungaußendurchmesser des Kanülenträgers und Vorsprunginnendurchmesser der Lagerhülse erfordert, um die zeitlich abfolgende Durchstechung der Verschlußstopfen der Behälter zu erzielen. Die Vorsprünge bedingen im übrigen einen erhöhten Fertigungsaufwand der Vorrichtung, bezogen auf die Herstellung des Kanülenträgers und des Hohlkörpers, im übrigen ist die Montage der Vorrichtung im Bereich des Kanülenträgers recht aufwendig.In the known device, a circumferential projection is provided both on the cannula support and on a bearing sleeve forming part of the hollow body. The resistance resulting from the contact between the two projections for driving over the projection on the bearing sleeve side is greater than the penetration resistance of the cannula when penetrating into the sealing plug of the first container. The disadvantage here is that the formation of the parts with the projections requires an exact dimensioning of the outer projection diameter of the cannula holder and the inner projection diameter of the bearing sleeve in order to achieve the chronological puncturing of the sealing plugs of the containers. The projections also require an increased manufacturing outlay for the device, based on the manufacture of the cannula holder and the hollow body, and the rest of the assembly of the device in the area of the cannula holder is quite complex.
Es ist Aufgabe der vorliegenden Erfindung, eine Vorrichtung der eingangs genannten Art so weiter zu bilden, daß diese bei baulich einfacher Gestaltung eine unkomplizierte verwechselungssichere und nicht umkehrbare Handhabung ermöglicht.It is an object of the present invention to develop a device of the type mentioned at the outset in such a way that, with a structurally simple design, this enables uncomplicated, reliable and irreversible handling.
Gelöst wird die Aufgabe bei einer Vorrichtung der eingangs genannten Art dadurch, daß der Kanülenträger als plattenförmiger, senkrecht zur Längsrichtung des Hohlkörpers orientierter Körper ausgebildet ist, der über Haltestege mit der Innenwandung des Hohlkörpers verbunden ist, wobei die Haltestege durch Aufbringen einer manuellen Kraft zerreißbar sind, die größer ist als die Durchdringkraft der Kanüle beim Durchstechen des Verschlußstopfens des ersten Behältnisses.The object is achieved in a device of the type mentioned above in that the cannula carrier is designed as a plate-shaped body oriented perpendicular to the longitudinal direction of the hollow body, which is connected to the inner wall of the hollow body by means of retaining webs, the retaining webs being able to be torn by applying a manual force , which is greater than the penetration force of the cannula when piercing the sealing plug of the first container.
Erfindungsgemäß wird damit der Kanülenträger vor dem Einstechen der Kanüle in den Verschlußstopfen des zweiten Behältnisses mittels der plattenförmigen Haltestege an der Innenwandung des Hohlkörpers fixiert. Eine Verschiebung der Kanüle ist deshalb nur dann möglich, wenn die Haltestege zuvor durch Aufbringen der manuellen Kraft zerrissen wurden. Es ist damit eine sichere sequentielle Abfolge der Bewegung gewährleistet. Die Ausbildung der Vorrichtung ermöglicht deren einfache Gestaltung, indem sie, gegebenenfalls bis auf die Kanüle, als Kunststoffspritzgußteil ausgestaltet ist.According to the invention, the cannula holder is thus fixed to the inner wall of the hollow body by means of the plate-shaped retaining webs before the cannula is inserted into the sealing plug of the second container. A displacement of the cannula is therefore only possible if the holding bars were previously torn by applying the manual force. This ensures a safe sequential sequence of the movement. The design of the device enables its simple design by, as the case may be, down to the cannula Plastic injection molded part is designed.
Gemäß einer besonderen Ausführungsform der Erfindung ist vorgesehen, daß der Kanülenträger mit auf die Innenwandung des Hohlkörpers zu gerichteten Führungsansätzen verbunden ist. Diese ermöglichen nach dem Trennen der Haltestege eine weitgehend verkantungsfreie Führung des Kanülenträgers relativ zur Innenwandung des Hohlkörpers, somit eine weitgehend exakte Führung der Kanüle im Einstechbereich zum zweiten Behältnis, wobei die Kanüle zudem im Verschlußstopfen des ersten Behältnisses gehalten ist.According to a particular embodiment of the invention it is provided that the cannula carrier is connected to guide projections which are directed towards the inner wall of the hollow body. After the holding webs have been separated, these enable the cannula holder to be guided largely without tilting relative to the inner wall of the hollow body, and thus a largely exact guidance of the cannula in the piercing area to the second container, the cannula also being held in the sealing plug of the first container.
Vorteilhaft weist der Hohlkörper eine Öffnung mit Kreisquerschnitt auf. Insbesondere bei einer solchen Gestaltung der Hohlkörperöffnung bietet sich eine dreieck- oder kreisförmige Ausbildung des Kanülenträgers an. Der Kanülenträger weist beispielsweise die Form eines gleichseitigen Dreiecks auf, mit drei Führungsansätzen, die im Bereich der Mitten der Dreiecksseiten des Kanülenträgers mit diesem verbunden sind. Bei einem kreisförmigen Kanülenträger sind bevorzugt vier jeweils um 90 Grad zueinander versetzt angeordnete Führungsansätze am Umfang des Kanülenträgers mit diesem verbunden. Die Führungsansätze können radial außen konzentrisch zur Kanüle und sich in Längsrichtung des Hohlkörpers erstreckende Führungsfahnen aufweisen.The hollow body advantageously has an opening with a circular cross section. In particular with such a configuration of the hollow body opening, a triangular or circular configuration of the cannula holder is appropriate. The cannula holder has, for example, the shape of an equilateral triangle, with three guide lugs which are connected to the cannula holder in the area of the center of the triangular sides of the cannula holder. In the case of a circular cannula carrier, four guide lugs, each offset by 90 degrees to one another, are preferably connected to the circumference of the cannula carrier. The guide lugs can have radially outer concentric to the cannula and guide lugs extending in the longitudinal direction of the hollow body.
Eine bevorzugte Weiterbildung der Erfindung sieht vor, daß mit der Innenwandung des Hohlkörpers in dessen Längsrichtung verlaufende Leitansätze verbunden sind, zwischen denen die Führungsansätze oder die Ecken des Kanülenträgers angeordnet sind. Der jeweilige Führungsansatz sollte dabei über einen Mittelsteg mit dem Kanülenträger verbunden sein und jeweils zwei Leitansätze den Führungsansatz im Bereich des Mittelsteges hintergreifen. Die Gestaltung des Hohlkörpers mit Leitansätzen bedingt eine definierte Positionierung des Kanülenträgers relativ zum Hohlkörper während dessen Verschiebung in Längsrichtung und verhindert dabei auch eine relative Drehung bzw. ein Kippen des Kanülenträgers zum Hohlkörper.A preferred development of the invention provides that guide projections extending in the longitudinal direction thereof are connected to the inner wall of the hollow body, between which the guide projections or the corners of the cannula holder are arranged. The respective guide approach should be connected to the cannula support via a central web and two guide approaches should engage behind the guide approach in the area of the central web. The design of the hollow body with guide lugs necessitates a defined positioning of the cannula carrier relative to the hollow body during its displacement in the longitudinal direction and also prevents relative rotation or tilting of the cannula carrier relative to the hollow body.
Zum Verbessern der Führung des Behältnisses im Hohlkörper, ist dieser vorteilhaft im Bereich mindestens eines Endes parallel zum von der zugeordneten Hohlkörperöffnung aufzunehmenden Behältnis verlängert. Die Verlängerung bewirkt, daß das Behältnis nicht nur im Bereich des den Verschlußstopfen aufweisenden Behälterhalses gehalten ist, sondern der verlängerte Abschnitt des Hohlkörpers auch den in aller Regel erweiterten, voluminösen Bereich des Behältnisses zumindest teilweise mit mehr oder wenig großem Abstand umgibt, so daß ein Kippen des Behältnisses im Hohlkörper ausgeschlossen ist. Von Bedeutung ist dies insbesondere für das Behältnis, das die Substanz unter Unterdruck bzw. Vakuumbedingungen aufnimmt, demnach beim Überleiten der Flüssigkeit in dieses Behältnis nicht aktiv geführt werden muß, sondern dies nur bei dem anderen, die Flüssigkeit aufnehmenden Behältnis erforderlich ist. Zweckmäßig weist der verlängerte Abschnitt des Hohlkörpers einen Innendurchmesser auf, der geringfügig größer ist als der Außendurchmesser des Behältnisses. Es wird hierdurch nicht nur das versehentliche Kippen des Behältnisses verhindert, sondern das Behältnis definiert geführt.To improve the guidance of the container in the hollow body, it is advantageously extended in the area of at least one end parallel to the container to be received by the associated hollow body opening. The extension causes the container not only in the area of the plug having the container neck is held, but the extended portion of the hollow body also at least partially surrounds the generally enlarged, voluminous area of the container at a greater or lesser distance, so that tilting of the container in the hollow body is excluded. This is particularly important for the container that holds the substance under negative pressure or vacuum conditions, so that when the liquid is transferred into this container, it does not have to be actively carried out, but is only required for the other container that holds the liquid. The elongated section of the hollow body expediently has an inner diameter which is slightly larger than the outer diameter of the container. This not only prevents the container from accidentally tipping over, but also guides the container in a defined manner.
Es ist insbesondere vorgesehen, daß die Vorrichtung mit den beiden Behältnissen ein vormontiertes, steril verpacktes System bildet, bei dem die beiden Behältnisse außer Kontakt mit der Kanüle im zylindrischen Hohlkörper gehalten sind und ein Packmittel die Behältnisse und den Hohlkörper steril einschließt.It is particularly provided that the device with the two containers forms a preassembled, sterile packaged system, in which the two containers are kept out of contact with the cannula in the cylindrical hollow body and a packaging includes the containers and the hollow body in a sterile manner.
Nachdem die Überleitung der Flüssigkeit unter sterilen Verhältnissen in einer Umverpackung möglich ist, stehen damit ein Überleitsystem und eine Verpackung zur Verfügung, die die Zubereitung der in den Behältnissen befindlichen Komponenten deutlich vereinfachen, beschleunigen und eine von der unmittelbaren Anwendung zeitlich völlig getrennte Vorbereitung gestatten, sowie eine Lagerung der rekonstituierten Komponenten über mehrere Tage ermöglichen. Die Gestaltung und Anordnung des Überleitsystems ermöglicht eine schnelle, sichere, verwechselungsfreie und nicht umkehrbare Überleitung der im ersten Behältnis befindlichen Komponente in das die andere Komponente enthaltende zweite Behältnis unter geringstmöglichem Aufwand für den Anwender und unter Aufrechterhaltung der Sterilität auch nach dem Zusammenführen der Komponenten.After the liquid can be transferred under sterile conditions in an outer packaging, a transfer system and packaging are available that significantly simplify, accelerate the preparation of the components in the containers, and allow preparation that is completely separate from the immediate use, as well as allow the reconstituted components to be stored for several days. The design and arrangement of the transfer system enables a quick, safe, confusion-free and irreversible transfer of the component located in the first container to the second container containing the other component with the least possible effort for the user and while maintaining sterility even after the components have been merged.
Weitere Merkmale der Erfindung sind in den Unteransprüchen, der Beschreibung der Figuren und den Figuren selbst dargestellt, wobei bemerkt wird, daß alle Einzelmerkmale und alle Kombinationen von Einzelmerkmalen erfindungswesentlich sind.Further features of the invention are shown in the subclaims, the description of the figures and the figures themselves, it being noted that all individual features and all combinations of individual features are essential to the invention.
In den Figuren ist die Erfindung anhand mehrerer Ausführungsformen beispielsweise dargestellt, ohne auf diese beschränkt zu sein. Es zeigt in schematischer Darstellung:
-
Figur 1 - den grundsätzlichen Aufbau eines vormontierten Überleitsystems unter Verwendung der Überleitvorrichtung, in einem Längsschnitt durch die Vorrichtung dargestellt,
-
Figur 2 - das vormontierte Überleitsystem gemäß
Figur 1, das von einer sterilen Umverpackung aufgenommen ist, - Figur 3a
- eine verkleinerte Darstellung des vormontierten Überleitsystems, d.h. vor dem Anstechen des ersten Behältnisses,
- Figur 3b
- das Überleitsystem nach Figur 3a nach dem Anstechen des ersten Behältnisses,
- Figur 3c
- das Überleitsystem gemäß der Figuren 3a und 3b, nach dem Anstechen des zweiten Behältnisses,
- Figur 4a
- eine vergrößerte Darstellung der in
Figur 1 gezeigten Überleitvorrichtung, in einem Längsmittelschnitt veranschaulicht, - Figur 4b
- einen Schnitt durch die Ausführungsform nach Figur 4a, senkrecht zur Längsachse der Kanüle im Bereich des Kanülenträgers geschnitten,
- Figur 5a
- eine gegenüber der Ausführungsform nach den Figuren 4a und 4b modifizierte Gestaltung der Vorrichtung, in einem Längsmittelschnitt,
- Figur 5b
- einen Schnitt durch die Ausführungsform nach Figur 5a, senkrecht zur Längsachse der Kanüle im Bereich des Kanülenträgers geschnitten,
- Figur 6a
- eine weitere, gegenüber der Ausführungsform nach den Figuren 4a und 4b modifizierte Gestaltung der Vorrichtung, in einem Längsmittelschnitt gesehen,
- Figur 6b
- einen Schnitt durch die Ausführungsform nach Figur 6a, senkrecht zur Längsachse der Kanüle im Bereich des Kanülenträgers geschnitten,
- Figur 7a
- eine weitere, gegenüber der Ausführungsform nach Figur 6a modifizierte Gestaltung der Vorrichtung, in einem Längsmittelschnitt gesehen, mit beidendig eingeführten, teilweise dargestellten Behältnissen und
- Figur 7b
- einen Schnitt gemäß der Linie A-A in Figur 7a.
- Figure 1
- the basic structure of a pre-assembled transfer system using the transfer device, shown in a longitudinal section through the device,
- Figure 2
- the pre-assembled transfer system according to Figure 1, which is received by a sterile outer packaging,
- Figure 3a
- a reduced representation of the preassembled transfer system, ie before the first container is pierced,
- Figure 3b
- the transfer system according to FIG. 3a after piercing the first container,
- Figure 3c
- the transfer system according to FIGS. 3a and 3b, after the second container has been pierced,
- Figure 4a
- 2 shows an enlarged illustration of the transfer device shown in FIG. 1, illustrated in a longitudinal central section,
- Figure 4b
- 4 a section through the embodiment according to FIG. 4 a, cut perpendicular to the longitudinal axis of the cannula in the region of the cannula holder,
- Figure 5a
- a design of the device modified in comparison to the embodiment according to FIGS. 4a and 4b, in a longitudinal central section,
- Figure 5b
- 5 a section through the embodiment according to FIG. 5 a, cut perpendicular to the longitudinal axis of the cannula in the region of the cannula holder,
- Figure 6a
- 4 shows a further design of the device, modified from the embodiment according to FIGS. 4a and 4b, seen in a longitudinal central section,
- Figure 6b
- 6 a section through the embodiment according to FIG. 6 a, cut perpendicular to the longitudinal axis of the cannula in the region of the cannula holder,
- Figure 7a
- a further, compared to the embodiment of Figure 6a modified design of the device, seen in a longitudinal central section, with both ends inserted, partially shown containers and
- Figure 7b
- a section along the line AA in Figure 7a.
Figur 1 zeigt einen zylindrischen Hohlkörper 3, dessen beide Hohlkörperöffnungen 6 und 7 gleichen Innendurchmesser aufweisen. Die auf die Orientierung der Figur 1 bezogen obere Hohlkörperöffnung 6 dient der Aufnahme einer eine Flüssigkeit aufnehmenden Flasche 1, die untere Öffnung 7 der Aufnahme einer eine Substanz unter Unterdruck bzw. Vakuumbedingungen aufnehmenden Flasche 2. Die Öffnung der jeweiligen Flasche 1 bzw. 2 verschließt ein nicht gezeigter Gummistopfen, der mittels einer Bördelkappe 4 bzw. 5 gehalten ist. Im Bereich der jeweiligen Bördelkappe 4 bzw. 5 ist die Flasche 1 bzw. 2 in den Hohlkörper 3 eingesteckt und von dieser gehalten. Etwa im Bereich der halben Länge des Hohlkörpers 3 ist ein plattenförmiger Kanülenträger 9 innerhalb des Hohlkörpers 3 angeordnet, der senkrecht zur Mittellängsachse 31 des Hohlkörpers 3 positioniert ist. Der Kanülenträger 9 ist über mehrere radial verlaufende Haltestege 13 mit der Innenwandung 30 des Hohlkörpers 3 fest verbunden. Der Kanülenträger 9 weist ein Durchgangsloch zur Aufnahme einer Kanüle 8 auf, deren Durchgangsachse mit der Mittellängsachse 31 zusammenfällt.
Die Flasche 2 kontaktiert nach dem Einstecken in den Hohlkörper 3 mit der Innenwandung 30 des Hohlkörpers 3 verbundene Anschläge 10, so daß sie nicht weiter in Richtung der Kanüle 8 in den Hohlkörper 3 einschiebbar ist, sondern vielmehr zwischen dem zugeordneten Innenwandungsabschnitt des Hohlkörpers 3 geklemmt ist. Die die Flüssigkeit aufnehmende Flasche 1 hingegen ist in einer vormontierten Stellung in einem dem eigentlichen Hohlkörperöffnungsbereich zugewandten Abschnitt des Hohlkörpers 3 gehalten, wobei ein parallel zum Kanülenträger 9 orientierter innerer Ringwulst 33 in den Verschiebeweg der Bördelkappe 4 ragt und damit die Montageposition definiert. In der in Figur 1 gezeigten, vormontierten Stellung des aus den beiden Flaschen 1 und 2 und dem Hohlkörper 3 mit Kanülenträger 9 und Kanüle 8 gebildeten Überleitsystems befinden sich die Bördelkappen 4 und 5 und somit die Gummistopfen zum Verschließen der Flaschen 1 und 2 in geringfügigem Abstand zu den beiden Enden der Kanüle 8. In diesem Zustand wird das Überleitsystem bereits beim pharmazeutischen Hersteller in eine peelbare Umverpackung 14 eingesiegelt und sterilisiert, wie es in Figur 2 veranschaulicht ist. Diese Umverpackung 14 besteht aus einer tiefziehbaren Weichblisterfolie, vorzugsweise PA/PE und einem sterilisierfähigen, siegelbaren medizinischen Papier oder einem Polyethylen-Spinnvlies. Nach dem Einsiegeln der etikettierten und montierten Einheiten erfolgt eine Sterilisation beispielsweise mit Ethylenoxid. In einer entsprechend gestalteten Sekundärverpackung führt der Anwender dann die Zubereitung der Komponenten in der sterilen Umverpackung durch, unter Aufrechterhaltung der Sterilität trotz Anstechens der jeweiligen Behältnisse.Figure 1 shows a cylindrical
After insertion into the
Die Figuren 3a bis 3c verdeutlichen die Vorgänge, um die Komponenten zusammenzuführen. Figur 3a veranschaulicht das vormontierte System, wie es in Figur 1 dargestellt ist. Ausgehend hiervon wird die die Flüssigkeit aufnehmende Flasche 1 weiter in den Hohlkörper 3 eingeschoben, wobei die Kanüle 8 den Verschlußstopfen der Flasche 1, der aus Gummi besteht, durchdringt. Dies ist deshalb möglich, weil die Eindring- bzw. Durchdringkraft der Kanüle 8 in bzw. durch den Gummistopfen der Flasche 1 geringer ist als die Kraft, die erforderlich ist, um den über die Haltestege 13 an den Hohlkörper 3 angebundenen Kanülenträger 9 von diesem zu trennen. In der in Figur 3b gezeigten vorgeschobenen Position der Flasche 1, bei der die Kanüle 8 den Gummistopfen durchstochen hat, gelangt die Bördelkappe 4 dieser Flasche 1 in Anlage mit dem Kanülenträger 9, womit die manuell auf die Flasche 1 ausgeübte Einschiebekraft zum Einschieben der Flasche 1 in den Hohlkörper 3 unmittelbar auf den Kanülenträger 9 übertragen wird. Beim Aufbringen einer entsprechend hohen manuellen Kraft reißen die Haltestege 13, so daß die Flasche 1 zusammen mit dem Kanülenträger 9 und damit der Kanüle 8 weiter in Richtung der Flasche 2 innerhalb des Hohlkörpers 3 verschoben wird, sodaß die Kanüle 8 den Gummistopfen dieser Flasche 2 durchsticht. Der in der Flasche 2 befindliche Unterdruck saugt die Flüssigkeit aus der Flasche 1 in die Flasche 2 und führt zur Auflösung bzw. Durchmischung der in dieser befindlichen festen bzw. flüssigen Komponente. Das System mit in Überleitstellung befindlicher Kanüle 8 ist in Figur 3c gezeigt.Figures 3a to 3c illustrate the processes to bring the components together. Figure 3a illustrates the pre-assembled system as shown in Figure 1. Proceeding from this, the liquid-absorbing
Die Figuren 4a und 4b veranschaulichen die in den Figuren 1 bis 3c zum Überleitsystem beschriebene Vorrichtung zum Zusammenführen der Komponenten im Detail. Bei dieser Ausführungsform der Vorrichtung ist der Hohlkörper 3 im Bereich der Hohlkörperöffnung 6 als Kranz 34 mit nur durch Dünnstellen miteinander verbundenen Haltestegen 16 ausgebildet. Hierdurch ist es möglich, Flaschen 1 unterschiedlichen Volumens zu verwenden, beispielsweise alle Injektionsflaschen von 6 bis 100 ml, da beim Aktivieren der Flasche 1 mit einem Nennvolumen größer/gleich 10 ml ein Einschieben in den Hohlkörper 3 nur möglich ist, wenn der zunächst zur Fixierung benutzte Ring gesprengt wird und dem größeren Körperdurchmesser der Flasche 1 Platz bietet.FIGS. 4a and 4b illustrate the device for merging the components described in FIGS. 1 to 3c for the transfer system in detail. In this embodiment of the device, the
Wie insbesondere der Darstellung der Figur 4b zu entnehmen ist, weist der Kanülenträger 9 im wesentlichen die Form eines Kreises auf und ist mit vier Führungsansätzen 35 versehen, die am Umfang des Kanülenträgers 9 um jeweils 90° zueinander versetzt mit diesem verbunden sind. Die Führungsansätze 35 weisen radial außen eine konzentrisch zur Kanüle 8 und sich in Längsrichtung des Hohlkörpers 3 erstreckende Führungsfläche 36 auf. Diese ist in geringem Abstand zur Innenwandung 30 des Hohlkörpers 3 angeordnet, so daß der Kanülenträger 9 nach dem Zerreißen der Haltestege 13 spielfrei und damit kippsicher im Hohlkörper 3 verschieblich ist. Im übrigen ist der Hohlkörper 3 innen mit vier, in Längsrichtung des Hohlkörpers 3 verlaufenden, jeweils um 90° zueinander versetzt angeordneten Rippen 37 versehen, die den Aufnahmedurchmesser des Hohlkörpers 3 für die Flasche 1 vorgeben und damit eine exakte Positionierung der Flasche 1 gewährleisten, wobei das Einschieben dieser Flasche 1 wegen deren Anlage mit ihrer Bördelkappe 4 an den Rippen 37 bei geringem Kraftaufwand erfolgen kann. Die Rippen 37 durchsetzen Ausnehmungen 38 zwischen den Führungsansätzen 35.As can be seen in particular from the illustration in FIG. 4b, the
Mit der Bezugsziffer 15 ist ein in der Ebene der Anschläge 10 angeordneter und mit dem Inneren des Hohlkörpers 3 verbundener Haltesteg bezeichnet, der nach der Rekonstitution der Komponenten beim Herausziehen der Flasche 2 aus dem Hohlkörper 3 verhindert, daß der Kanülenträger 9 aus dem Hohlkörper 3 herausfällt bzw. die im Kanülenträger 9 gehaltene Kanüle 8 im Gummistopfen der Flasche 2 stecken bleibt.
Bei der Ausführungsform nach den Figuren 5a und 5b weist der Kanülenträger 9 im wesentlichen die Form eines gleichseitigen Dreieckes auf und es sind drei Führungsansätze 35 vorgesehen, die im Bereich der Mitten der Dreiecksseiten des Kanülenträgers 9 mit diesem verbunden sind. Mit der Innenwandung 30 des Hohlkörpers 3 sind in dessen Längsrichtung verlaufende, flügelartige Leitansätze 12 verbunden, zwischen denen die Führungsansätze 35 des Kanülenträgers 9 angeordnet sind. Der jeweilige Führungsansatz 35 ist über einen Mittelsteg 39 mit dem Kanülenträger 9 verbunden und es hintergreifen jeweils zwei benachbarte Leitansätze 12 den Führungsansatz 35 im Bereich des Mittelsteges 39. Jeder Führungsansatz 35 ist über einen Haltesteg 13 mit dem Hohlkörper 3 verbunden. Die Dreiecksabmessung des Kanülenträgers 9 ist so gewählt, daß dessen Spitzen mit minimalem Spiel zur Innenwandung 30 des Hohlkörpers 3 positioniert sind, was im übrigen auch für die Position von Führungsfläche 36 des jeweiligen Führungsansatzes 35 und Innenwandung 30 des Hohlkörpers 3 gilt. Benachbarte Leitansätze 12 sind so zur Innenwandung 30 divergierend angeordnet, daß sie zwischen sich eine Ecke 40 des Kanülenträgers 9 aufnehmen.In the embodiment according to FIGS. 5a and 5b, the
Bei der Ausführungsform nach den Figuren 5a und 5b erfolgt die Vormontage der Bördelkappe 4 der Flasche 1 auf den Leitansätzen 12 bis gegen die rückspringenden Ansätze 11 der Leitansätze 12. Beim weiteren Einschieben dieser Flasche 1 zum Durchstechen der Kanüle 8 werden die Leitansätze 12 nach radial außen gebogen, die Bördelkappe 4 gelangt in Anlage mit dem Kanülenträger 9 und es werden beim Aufbringen einer erhöhten manuellen Kraft die Haltestege 13 gesprengt.In the embodiment according to FIGS. 5a and 5b, the
Bei der Ausführungsform nach den Figuren 7a und 7b weist die Hohlkörperöffnung 7 (gegenüber der Ausführungsform nach Figur 6a) eine größere Längserstreckung auf. Erreicht wird dies durch eine Verlängerung des die Öffnung bildenden Ringabschnittes 45 des Hohlkörpers 3. Der Innendurchmesser des Ringabschnittes ist geringfügig größer bemessen als der Außendurchmesser der Flasche 2 im Flaschenabschnitt 46. Bei vollständig in die untere Öffnung 7 eingesetzter Flasche 2 kontaktiert diese mit ihrer den Gummistopfen umschließenden Bördelkappe 5 die Anschläge 10 des Hohlkörpers 3, wobei die Bördelkappe 5 mittels Rippen 47 geführt ist, die diametral mit der Innenwandung 30 des Hohlkörpers 3 verbunden sind. Figur 7 verdeutlicht, daß der Außendurchmesser der Bördelkappe 5 geringer ist als der Außendurchmesser des Behältnisses 2 und sich der Ringabschnitt 45 bis seitlich des Flanschabschnittes 46 erstreckt. Hierdurch ist ein Kippen der Flasche 2 in der Hohlkörperöffnung 7 wirksam verhindert. Die obere Hohlkörperöffnung 6 ist entsprechend ausgebildet, das heißt es erfolgt auch dort eine Führung der Flasche 1 im Bereich ihres Flaschenabschnittes 46, somit ihres maximal erweiterten Bereiches.In the embodiment according to FIGS. 7a and 7b, the
Die Überleitvorrichtung gemäß der Figuren 4a und 4b ist geeignet für Injektionsflaschen 1 und 2 mit einer Nenngröße von 20 mm. Die Überleitvorrichtung nach den Figuren 5a und 5b dient dem Überleiten einer Substanz aus einer Flasche 1 mit einer Nenngröße von 13 mm in eine Flasche 2 mit einer Nenngröße von 20 mm. Bei der Ausführungsform nach den Figuren 6a und 6b, die bis auf die Gestaltung der Hohlkörperöffnung 7 identisch ist mit der Ausführungsform nach den Figuren 5a und 5b, dient die Vorrichtung der Aufnahme von Flaschen 1 und 2 mit einer Nenngröße von 13 mm. Auch die Ausführungsform nach den Figuren 7a und 7b dient der Aufnahme von Flaschen 1 und 2 mit einer Nenngröße von 13 mm.The transfer device according to FIGS. 4a and 4b is suitable for
Claims (17)
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
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DE1995113666 DE19513666C1 (en) | 1995-04-11 | 1995-04-11 | Device for bringing together a first liquid and a second solid or liquid component by means of negative pressure under sterile conditions |
DE19513666 | 1995-04-11 |
Publications (2)
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EP0737467A1 true EP0737467A1 (en) | 1996-10-16 |
EP0737467B1 EP0737467B1 (en) | 1999-06-02 |
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EP19960103858 Expired - Lifetime EP0737467B1 (en) | 1995-04-11 | 1996-03-12 | Device for putting together a first liquid component and a second rigid or liquid component by means of vacuum under sterile conditions |
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US (1) | US5743312A (en) |
EP (1) | EP0737467B1 (en) |
JP (2) | JP3228496B2 (en) |
KR (1) | KR100388864B1 (en) |
AT (1) | ATE180663T1 (en) |
AU (1) | AU697521B2 (en) |
CA (1) | CA2173823C (en) |
DE (2) | DE19513666C1 (en) |
DK (1) | DK0737467T3 (en) |
ES (1) | ES2134527T3 (en) |
GR (1) | GR3030958T3 (en) |
ZA (1) | ZA962802B (en) |
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EP1287804A2 (en) | 2001-08-31 | 2003-03-05 | Aventis Behring GmbH | Device for bringing components together in sterile conditions |
EP1372852A1 (en) * | 2001-03-08 | 2004-01-02 | Exelixis, Inc. | Multi-well apparatus |
AT503915B1 (en) * | 2006-06-21 | 2008-02-15 | Friedrich Ing Pipelka | Transfer device for transferring a fluid from one container to another container comprises locking protrusions arranged in an adapter for locking a container in holders of the adapter |
WO2011104711A1 (en) * | 2010-02-24 | 2011-09-01 | Medimop Medical Projects Ltd | Fluid transfer assembly with venting arrangement |
US8051884B2 (en) | 2006-07-27 | 2011-11-08 | Csl Behring Gmbh | Device for combining components by means of negative pressure under sterile conditions |
US8066688B2 (en) | 2004-04-29 | 2011-11-29 | Medimop Medical Projects Ltd. | Liquid drug medical device |
US8070739B2 (en) | 2005-08-11 | 2011-12-06 | Medimop Medical Projects Ltd. | Liquid drug transfer devices for failsafe correct snap fitting onto medicinal vials |
USD669980S1 (en) | 2010-10-15 | 2012-10-30 | Medimop Medical Projects Ltd. | Vented vial adapter |
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Also Published As
Publication number | Publication date |
---|---|
US5743312A (en) | 1998-04-28 |
ATE180663T1 (en) | 1999-06-15 |
JPH08280778A (en) | 1996-10-29 |
JP3228496B2 (en) | 2001-11-12 |
DK0737467T3 (en) | 1999-11-29 |
GR3030958T3 (en) | 1999-11-30 |
AU697521B2 (en) | 1998-10-08 |
ZA962802B (en) | 1996-10-11 |
ES2134527T3 (en) | 1999-10-01 |
EP0737467B1 (en) | 1999-06-02 |
KR960037033A (en) | 1996-11-19 |
KR100388864B1 (en) | 2004-03-19 |
JP3704295B2 (en) | 2005-10-12 |
CA2173823C (en) | 2006-06-20 |
DE19513666C1 (en) | 1996-11-28 |
JP2001333961A (en) | 2001-12-04 |
AU5053996A (en) | 1996-10-24 |
DE59602051D1 (en) | 1999-07-08 |
CA2173823A1 (en) | 1996-10-12 |
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