EP2531165B1 - Device for removing fluids from vials - Google Patents

Device for removing fluids from vials Download PDF

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Publication number
EP2531165B1
EP2531165B1 EP20100801102 EP10801102A EP2531165B1 EP 2531165 B1 EP2531165 B1 EP 2531165B1 EP 20100801102 EP20100801102 EP 20100801102 EP 10801102 A EP10801102 A EP 10801102A EP 2531165 B1 EP2531165 B1 EP 2531165B1
Authority
EP
European Patent Office
Prior art keywords
container
device
fluid channel
inlet opening
opening
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 - Fee Related
Application number
EP20100801102
Other languages
German (de)
French (fr)
Other versions
EP2531165A2 (en
Inventor
William Brem
Ralph Egon Kayser
Andy Greter
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.)
MEDMIX SYSTEMS AG
Original Assignee
MEDMIX SYSTEMS AG
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
Priority to CH1152010 priority Critical
Application filed by MEDMIX SYSTEMS AG filed Critical MEDMIX SYSTEMS AG
Priority to PCT/CH2010/000314 priority patent/WO2011091543A2/en
Publication of EP2531165A2 publication Critical patent/EP2531165A2/en
Application granted granted Critical
Publication of EP2531165B1 publication Critical patent/EP2531165B1/en
Application status is Expired - Fee Related legal-status Critical
Anticipated expiration legal-status Critical

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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
    • A61J1/05Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/14Details, e.g. provisions for hanging or shape retaining means; Accessories therefor, e.g. inlet or outlet ports, filters or caps
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2096Combination of a vial and a syringe for transferring or mixing 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
    • A61J1/05Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/14Details, e.g. provisions for hanging or shape retaining means; Accessories therefor, e.g. inlet or outlet ports, filters or caps
    • 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
    • A61J1/05Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/14Details, e.g. provisions for hanging or shape retaining means; Accessories therefor, e.g. inlet or outlet ports, filters or caps
    • 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
    • A61J1/2013Piercing means having two piercing ends
    • 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
    • A61J1/14Details, e.g. provisions for hanging or shape retaining means; Accessories therefor, e.g. inlet or outlet ports, filters or caps
    • 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
    • A61J1/2048Connecting means
    • A61J1/2051Connecting means having tap means, e.g. tap means activated by sliding
    • 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
    • A61J1/14Details, e.g. provisions for hanging or shape retaining means; Accessories therefor, e.g. inlet or outlet ports, filters or caps
    • 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
    • A61J1/2048Connecting means
    • A61J1/2055Connecting means having gripping means
    • 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
    • A61J1/14Details, e.g. provisions for hanging or shape retaining means; Accessories therefor, e.g. inlet or outlet ports, filters or caps
    • 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
    • A61J1/2048Connecting means
    • A61J1/2058Connecting means having multiple connecting 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
    • A61J1/05Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/14Details, e.g. provisions for hanging or shape retaining means; Accessories therefor, e.g. inlet or outlet ports, filters or caps
    • 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

Abstract

The invention relates to a device for removing a fluid from at least one container (300), from a vial for example, said container being closed by a closure (320) that can be punctured. The device comprises a base body (271) with a container receiving portion (272) and a hollow needle-like puncturing organ (277) in order to puncture the closure (320) of the container (300) in a removal position of the container (300). The aim of the invention is to enable mounting the container on the device without unintentionally puncturing the closure. This is achieved in that detent structures (274, 275) are provided which retain the container (300) on the device in a removal position and in a mounting position which is different from said removal position. Such a device can be used in particular to fill an applicator (280) with one or more fluid reservoirs from one or more vitals.

Description

    TECHNICAL AREA
  • The present invention relates to a device for withdrawing a fluid from at least one container, in particular from a container closed by a pierceable closure, e.g. a vial with septum closure. In particular, the present invention relates to a device for filling an applicator with at least one fluid reservoir of one or more vials.
  • STATE OF THE ART
  • In various applications, the task is to produce and discharge a mixture of two or more flowable components in a predetermined mixing ratio. An example is the preparation of an adhesive for technical or medical applications, e.g. a medical glue based on fibrin. Another example is the preparation of a multi-component bone cement using a monomer. Also, there are e.g. Medicines made by mixing two or more components that are non-storable when mixed. In this case, it is desirable to first store the components separately and to mix them just prior to their administration. Similar tasks also arise in other pharmaceutical or chemical systems of two or more components that are not stable in the mixed state.
  • From the state of the art, it is known to take the components to be mixed separately in two reservoirs of an applicator, for example in the form of a double syringe, and to discharge them therefrom through a suitable mixing device. However, it is often problematic, flowable substances over a To store longer period in applicators made of plastic, because on the one hand, the substances can react chemically with the plastic, and on the other hand there is a risk that gases, in particular atmospheric oxygen, diffuse through the walls of the applicator or through sealing points and chemically alter the content. This is especially true for medical applications where chemical purity is of particular importance.
  • It is therefore known to store the components to be mixed separately in so-called vials, especially in glass vials with septum closure, i. in sterilizable glass vials, which are closed at one end by a pierceable, self-sealing membrane (a so-called septum), to absorb the components to be mixed only shortly before application from the vials in two separate reservoirs. For this purpose, in the prior art adapter-like devices have been proposed, which allow a simultaneous filling of two reservoirs of two vials.
  • So is in US 6,610,033 discloses a filling system including a vial holder for holding two vials in parallel and a syringe holder for holding two syringes in parallel. To remove material from the vials, the syringes pierce the septa of the vials directly with a piercing adapter. This has the disadvantage that the syringes must be equipped with such an adapter or with needles and necessarily require a certain distance, which is determined by the diameter and spacing of the vials.
  • US 6,488,650 discloses several embodiments of a filling device that makes it possible to treat a dual syringe type applicator with two reservoirs of two vials. The device has a connection region on which two connections for the reservoirs are formed. On the opposite side of a hood for receiving the vials is formed. When inserting the vials into the hood, the septa of the vials are pierced by hollow needles, which communicate via fluid channels with the connections for the reservoirs. The fluid channels divert the fluids between the vials and the reservoir ports so that the reservoir spacing may be less than the pitch of the hollow needles.
  • However, the structure of such a filling device is relatively complicated: the device comprises two separately formed housing halves, which must be connected together to form the connection area and the hood. Before connecting the two halves, the fluid channels are inserted with the connections for the reservoirs and with the hollow needles in the housing halves. This leads to a relatively complicated manufacturing process and correspondingly increased costs. In addition, the loss volume of such a device is relatively large.
  • Other filling devices for an applicator with two reservoirs of vials are in document WO 99/17833 in particular in Figures 26-27A of that document. The document is silent about the exact design of the fluid channels. As far as Figure 27 of the document can be seen, two housing parts seem to be fluid-tightly connected to each other at the end face, wherein in one of the housing parts, a recess is formed on the front side, which forms the fluid channel. This design requires a very accurate fit and alignment of the two housing parts and is error-prone.
  • In WO 2009/144085 is in the FIGS. 8 Figure 14 discloses a filling device for a dual-syringe applicator of vials. This filling device has a disk-like base body with a bottom side and a top side. On the upper side, two inlet openings spaced from one another, which are connected to piercing members in cup-like vial holders, are formed. At the bottom two outlet openings are formed with a smaller distance, to which the applicator is connectable. In each case an inlet opening and outlet opening are connected to one another by a fluid channel running perpendicular to these openings. This filling device also has a relatively large loss volume.
  • In such devices, the vials are usually simply inserted into the device to puncture the septa. In some of these devices, the vials are then, after complete insertion into the device and after puncture of the septa, fixed by a latching connection to the device. However, known devices are usually not suitable to the vials directly to the Store as it can not be ruled out that the septum of a vial is inadvertently punctured during transport or handling.
  • PRESENTATION OF THE INVENTION
  • According to a first aspect, the present invention provides an adapter-like device which makes it possible to remove a fluid from a container, wherein the fluid is deflected in the device, e.g. to fill at least one reservoir of an applicator from at least one container with a fluid, wherein the device has a reduced loss volume.
  • Such a device is specified in claim 1. Preferred embodiments are specified in the dependent claims.
  • Thus, a device for removing a fluid from at least one container is specified. The device has a base body with an upper side and a lower side, in which at least one fluid channel running along a longitudinal direction with a constant or variable cross-section is formed. At the top of the base body is at least one angled (ie angle not equal to 0 °, preferably amount of the angle> 30 °, more preferably perpendicular) formed to the fluid passage inlet opening which opens into the fluid channel, and at the bottom of the base body is at least one angled (Preferably, the amount of the angle> 30 °, more preferably perpendicular) to the fluid passage extending outlet opening formed, which also opens into the fluid channel. With respect to the longitudinal direction, the outlet opening is arranged offset relative to the inlet opening, ie the outlet opening and the inlet opening open at different locations along the fluid channel. The device also includes at least one container port for connecting a container to the inlet port, which may be done in any manner. In order to reduce the loss volume, at least one insertion opening extending along the longitudinal direction is formed in the base body and opening into the fluid passage, and an insert member is inserted through the insertion opening into the fluid passage. This insert element extends into the fluid channel in such a way that it reduces the cross section of the fluid channel in a region between the inlet opening and the outlet opening.
  • In particular, the insert element may have the form of a pin which extends into the fluid channel along the longitudinal axis.
  • The insert preferably sits sealingly in the fluid channel, i. it preferably has a peripheral surface (lateral surface) which abuts substantially sealingly between a boundary wall of the fluid channel between the inlet opening and the outlet opening and forms a fluid connection of reduced cross-section alone or together with a boundary wall of the fluid channel. In order to use the insert element in more than one very specific orientation with respect to a rotation about the longitudinal axis and yet to ensure a reliable fluid connection, in the peripheral surface of the insert element in the region of the inlet opening, a first annular groove may be formed, which is at least partially (preferably completely ) extends around the insert element, and in the region of the outlet opening, a second annular groove can be formed in the peripheral surface, which likewise extends at least partially (preferably completely) around the insert element. Between the first annular groove and the second annular groove then the mentioned fluid connection is formed. This can e.g. may be formed in the form of a connecting groove connecting the two annular grooves or may be e.g. be formed as a bore through the insert element. A connection groove is preferred. Alternatively or additionally, a flattening may be formed in the peripheral surface of the insert element (i.e., on its outer circumference) defining a gap between the boundary wall of the fluid channel and the insert element. In this case, the gap forms at least part of the fluid connection mentioned.
  • Such a connecting groove or flattening can also be advantageously used if no annular grooves are present, for example because the insert element is not rotationally symmetrical and therefore can be introduced in any case only in a single, fixed orientation with respect to a rotation about the longitudinal axis. The connecting groove or flattening may be parallel to the longitudinal direction or obliquely thereto, for example helically wound or meander-shaped, extend, but the shortest possible configuration is preferred in order to keep the loss volume low.
  • In those areas which lie outside the region between inlet opening and outlet opening, the insert element is preferably arranged sealingly in the base body, so that the fluid can not reach these areas.
  • In order to hold the insert element in the base body, a first latching structure may be formed on the insert element, and then a complementary second latching structure is formed on the base body. These locking structures then work together to hold the insert latching in the base member. In particular, the first latching structure may include an annular bead on the insert element, while the second latching structure comprises a complementary annular groove in a jacket wall of the fluid channel or the insertion opening.
  • In a preferred embodiment, the fluid channel and the insert element of complementary shape and at least partially (preferably at least in the region between the inlet opening and outlet opening) to the insertion towards conically widened. This makes it very easy to achieve the desired sealing effect between the peripheral surface of the insert element and the boundary wall of the fluid channel, even in the presence of dimensional tolerances.
  • The device can be used in particular as a filling device or adapter for filling at least one reservoir of an applicator from at least one container, in particular a vial. In particular, the applicator can be a syringe-like applicator in which the reservoir is delimited by a movable piston, so that the reservoir can be filled by retracting the piston from a distal end position into a proximal direction. For this purpose, the device preferably has an applicator connection in order to connect the reservoir of the applicator to the outlet opening. The applicator connection can be equipped with a holding device, in particular with a detachable latching connection, for the applicator. It can be made in one piece with the base body or separately from it. In the simplest case, the applicator connection is formed, for example, by a female luer cone; However, preferred is a special embodiment in which the loss volume is less than in a normal standardized luer connection, for example, an embodiment according to the embodiments described below. If the device serves to remove the fluid from at least one vial or other container with a pierceable closure, it preferably has in the region of the container connection a hollow needle-like piercing member connected to the inlet opening in order to pierce a closure of the container. In addition, the device in the region of the container connection preferably has a container receptacle which is designed to hold the container to the device.
  • Instead of as a filling device for filling an applicator from a container such. In a vial, the device can also be used for other purposes, e.g. as an adapter for connecting a container to an accessory, e.g. a mixer or atomizer. Also in such applications, it may be desirable to divert fluid between the container and the accessory while minimizing the loss volume. The container may then be e.g. a carpule (i.e., a container with a pierceable closure and displaceable piston) or a single or multiple syringe, and the container port may then be designed accordingly. Likewise, instead of an applicator connection, a suitably designed connection for the accessory can then be present.
  • In particular, the device can be configured for the simultaneous removal of fluids from at least two containers. For this purpose, the above features are present at least twice. In the case of two containers, the two fluid channels preferably run collinearly one behind the other along the longitudinal direction, wherein the insert elements are introduced from two opposite sides into the two fluid channels. In other words, in such cases, in the base body, a second fluid passage having a constant or variable cross-section running along the longitudinal direction is formed on the upper side of the base body, a second inlet opening extending at an angle to the second fluid channel, which opens into the second fluid channel, and at the bottom the base body is angled to the second fluid channel extending) second outlet opening, which opens with respect to the longitudinal direction offset from the second inlet opening of the second fluid channel. The device then has a second container port to connect a second container to the second inlet port. In the base body is then running along the longitudinal direction, the the first insertion opening facing away from the second inlet opening, which opens into the second fluid channel, and the filling device has a second insert element, which is inserted through the second insertion opening into the second fluid channel and reduces the cross section of the second fluid channel between the second inlet opening and the second outlet opening.
  • According to a further aspect, the present invention provides an adapter-like device for withdrawing a fluid from at least one container closed by a pierceable closure, which makes it possible to store the container on the device without unintentionally opening the container. Such a device is specified in claim 12. The two aspects of the invention can be used individually or combined with each other.
  • According to this aspect, therefore, an apparatus for removing a fluid from at least one of a container closed by a pierceable closure, in particular a vial, is specified, which comprises:
    • a base body in which an inlet port and an outlet port are formed, which are connected by a fluid passage;
    • a hollow needle-like piercing member connected to the inlet opening in order to pierce the closure of the container, in particular a septum closure, in a removal position of the container; and
    • a container receptacle connected to the base body to hold the container to the device.
  • In order to securely hold the container to the device prior to puncturing the closure and to prevent accidental puncturing, the container receptacle has a first latching structure to move the container to a storage position where the container is farther from the base body than in the removal position (And in the thereby the closure is not pierced) to fix by a releasable locking connection to the container receptacle.
  • Preferably, the container is also fixed in the removal position, and the container receptacle then additionally has a second latching structure for this purpose in order to secure the container in the removal position To fix removal position by a latching connection to the container receptacle.
  • The latching structures can interact directly or indirectly with the container. Thus, e.g. the container can be inserted directly into the container receptacle, the latching structures being attached directly to a corresponding retention structure, e.g. a rejuvenation, attack the container, or the container may be held on a separate holder which is inserted into the container receptacle or pushed onto this, wherein the latching structures of the container receptacle cooperate with a corresponding retention structure of the holder. It is also conceivable that the container receptacle has only a single latching structure, while the container or the holder has two retention structures, wherein in the storage position, the first of these retention structures with the (single) latching structure cooperates, while in the removal position, the second of these retention structures the latching structure cooperates.
  • Each of the latching structures is preferably designed as follows: The container receptacle has a preferably at least partly cylindrical jacket wall. The first latching structure and the second latching structure each comprise a spring arm formed in the casing wall, at the free end of which a latching nose extending into the interior of the casing wall is formed. This allows a very simple and inexpensive production. The latching structures are preferably arranged offset with respect to the circumferential direction of the jacket wall, in particular by approximately 180 ° offset, i. diametrically opposite one another in order to take up as little space as possible with the greatest possible stability of the container receptacle.
  • Specifically, the container receptacle can in particular be constructed as follows: It has a bottom, from which a pin extends into the inlet opening of the base body. Through the pin and bottom through a passage opening is formed, and the piercing member is held in the passage opening.
  • A device according to this aspect of the invention can also be designed as a filling device for an applicator, with an applicator connection of the type specified above. But it can also turn, for example, to remove a fluid from a Serving carpule. In particular, this device can also be designed for the simultaneous removal of fluids from at least two containers. In this case, the latching structures can be designed so that they fix the two or more containers simultaneously in the storage position or in the removal position.
  • When such a container receptacle is used together with an insert element of the type described above, the container receptacle may include a cover, e.g. a bottom-extending skirt, which covers the insertion opening for the insert element. This additionally secures the insert element in the base body.
  • The base body, the container receptacle and the applicator connection are preferably made of a thermoplastic material by injection molding.
  • BRIEF DESCRIPTION OF THE DRAWINGS
  • Preferred embodiments of the invention will be described below with reference to the drawings, which are given by way of illustration only and are not to be interpreted as limiting. In the drawings show:
  • Fig. 1
    a perspective view of a first embodiment of a filling device according to the invention;
    Fig. 2
    the filling of the Fig. 1 with inserted vials;
    Fig. 3
    a central longitudinal section through the filling of the Fig. 2 ;
    Fig. 4
    a detailed view of the area A of Fig. 3 ;
    Fig. 5
    an enlarged perspective view of an insert element;
    Fig. 6
    a perspective view of a second embodiment of a filling device according to the invention;
    Fig. 7
    a partial view of a central longitudinal section through the filling of the Fig. 6 ; and
    Fig. 8
    a detailed view of the area B of Fig. 7 ,
    DESCRIPTION OF PREFERRED EMBODIMENTS
  • In the FIGS. 1 to 5 a first embodiment of a filling device according to the invention is illustrated. The filling device 200 has a base body 210 of elongated, substantially disk-shaped basic shape. A central, cylindrical thickening 211 is formed on the base body 210, to which the two halves of a flat supporting plate 212 connect. The thickening 211 defines with its cylinder axis a longitudinal direction.
  • Along this longitudinal direction of each of the two ends of the cylindrical thickening 211 forth a blind hole-like longitudinal bore is formed, which ends in each case shortly before the center of the thickening ( FIGS. 3 and 4 ). Each of these holes widens slightly conically towards its open end to form a fluid channel. The two holes are collinear with each other, ie they lie on the same axis one behind the other.
  • To the top of the base body 210 toward an inlet opening 213 is formed in the region of the thickening for each of the holes ( Fig. 4 ). This inlet opening 213 connects the respective bore, each with a cup-shaped container receptacle 220. The container receptacle 220 has a circumferential cylindrical jacket wall which is formed multiple slotted from its upper edge, so that each of the interrupted by a slot portions of the jacket wall forms a spring arm. Retaining lugs protrude inwardly at the free ends of these resilient arm portions to latch a container 300 in a picking position on the container receptacle.
  • The containers 300 are present here in the form of so-called vials with septum closure. Each container comprises a Behälterköper 310, which is preferably made of glass, but may also consist of special plastic. To a flat bottom 311 is followed by a circumferential cylindrical jacket wall 312, which has a taper 313 near the bottom distal end. Subsequent to this rejuvenation, the mantle wall widens slightly again and delimits a container opening. The associated closure 320 comprises a septum 321 (a pierceable, self-closing Membrane, see Fig. 4 ) held by a crimped metal cover leaving a central part of the septum on the container opening.
  • In order to pierce the septum 321, a piercing member 230 of relatively hard plastic is inserted into the inlet opening 213, terminating in a tip 231 at its upper end. Laterally at the tip 231, a removal opening 232 is formed, which is connected to a central withdrawal channel 233, which in turn opens into the inlet opening 213 of the base body 210.
  • In the region of the closed end of the respective longitudinal bore of the base body 210, an outlet opening 214 is formed which leads to an applicator connection 240. In the present example, the applicator port 240 is formed integrally with the base body 210, but may be separately formed in front of the base body 210 and connected to the base body 210 in a suitable manner, e.g. glued or welded, be.
  • At the applicator connection, a double-syringe-like applicator 100 can be attached and detachably fastened. The applicator has an applicator body 110 with two cylindrical, parallel, proximally open reservoirs 111, 112 of equal or (here) different volume. The reservoirs open at their distal ends into outlets 116, 117. In the open proximal ends of the reservoirs in each case a piston 121, 122 is inserted. The two pistons are connected together at their proximal ends to form a piston unit. In this area, an actuating surface 123 is formed for a user's thumb. A retaining flange 113 serves to hold the applicator by means of index and middle fingers. The applicator can be handled in this respect as a commercial double syringe.
  • The present connection between the applicator 100 and the filling device 200 functionally corresponds substantially to the in WO 2007/109915 described connection between a syringe / cartridge and an accessory. In particular, the applicator 100 and the filling device 200 comprise retention means configured according to this document. Specifically, the applicator connection is designed as follows: Each of the outlet openings 214 of the two fluid channels opens into one conically widening insertion region for the outlets 116, 117 of the applicator 100. These outlets are correspondingly formed to be complementary to the insertion regions and can be inserted into these insertion regions. In order to hold the applicator 100 securely on the filling device 200, the applicator near its distal end, adjacent to the outlets, on two opposite sides two webs with latching noses 115 on. The applicator connection 240 has a cylindrical receiving region 241, which radially surrounds the insertion regions and the webs with the latching noses and on which two opposite snap-in openings are formed. The latching noses 115 snap when inserting the applicator into the snap-in openings of the receiving region 241.
  • In order to detach the applicator 100 from the filling device 200, the receiving region 241 is elastically deformable such that the latching connection between the latching noses 115 and the corresponding snap-in openings by pressure on a relative to the cylinder axis of the receiving area by approximately 90 degrees from the Einschnappöffnungen offset wall portion of the receiving area 241 is releasable again. By such a pressure, the receiving area 241 is deformed such that the snap-in openings are pressed radially outward away from the latching noses 115 and thereby get out of engagement with the latching noses. With regard to further details and further design possibilities of the connection between the applicator and the filling device, reference is made to the already mentioned WO 2007/109915 the contents of which are incorporated herein by reference.
  • In order to be able to exert this pressure selectively and simply, two opposite pressure wings 243 are formed on the support plate 212. A lateral compression of the two pressure vanes 243 is transferred offset to the Einschnappöffnungen on the cylindrical receiving portion 241 of the applicator 240 and thereby leads to release the locking connection between the applicator 100 and the filling device 200th
  • A Codierflügel 114 on the applicator 100 and a corresponding Codierflügel 242 on the filling device 200 indicate the correct orientation of the applicator 100 when connecting to the filling device 200 at. In addition, the terminals themselves are formed differently to ensure that the applicator 100 only in the correct orientation can be connected to the filling device 200.
  • In order to reduce the loss volume of the filling device, in each of the two longitudinally extending bores of the base body 210 is inserted in each case a pin-shaped or needle-shaped insert element 250, which in the Fig. 5 is shown alone. The insert member 250 serves to reduce the cross section of the fluid passage formed by the bore between the inlet port 213 and the outlet port 214. For this purpose, the insert element 250 is formed substantially complementary to the bore in the base body 210 and in particular also extends slightly towards the free end of the bore, so that it rests with its peripheral surface substantially sealingly against the boundary wall of the bore. In the region of the inlet opening 213, a first annular groove 251 is formed in the peripheral surface of the insert element 250, while a second annular groove 252 is formed in the region of the outlet opening 214. These annular grooves are interconnected by a longitudinally extending connecting groove. Together, the annular grooves 251, 252 and the connecting groove 253 establish a fluid communication between the inlet port 213 and the outlet port 214, which is commonly defined by the grooves and the boundary wall of the fluid channel. Instead of a straight connecting groove and a different shape can be selected. Alternatively or additionally, a flattening may also be provided on the circumferential surface, or the connecting groove may be replaced by a fine, eg diagonal, bore connecting the annular grooves.
  • The insert element 250 can be easily slid into the open end of the bore in any orientation along the longitudinal direction with the open end of the bore forming an insertion opening 216 for the insert element. Because of the circumferential annular grooves 251, 252, it does not depend on the exact orientation of the insert element with respect to a rotation of the insert element about the longitudinal axis. In order to secure the insert element 250 in the bore, it has in the region of the insertion opening an annular bead 254 which engages in an annular groove 215 of the base body 210. This allows a further securing of the insert element 250 in the base body 210, e.g. a bonding or welding, omitted.
  • For filling the two reservoirs 111, 112 of the applicator 100 is complete with inserted piston 121, 122 attached to the filling device 200. The containers 300 are inserted into the corresponding container receptacles until they reach the removal position in which the septa of the container 300 are pierced and the containers are latched to the container receptacles. Subsequently, the piston unit 120 is withdrawn to separately and simultaneously remove the fluids from the two containers and to transfer them into the reservoirs 111, 112. Only a small amount of the respective fluid is lost in the filling device. By pressure on the pressure wings 243, the applicator 100 is now released from the filling device 200. Subsequently, an accessory, such as a mixer or a sprayer, can be connected to the applicator, and the fluids can be discharged through the accessory from the applicator.
  • In the FIGS. 6 to 8 a second embodiment of a filling device according to the invention is illustrated. This embodiment differs from the first embodiment mainly by the embodiment, the container receptacles. The container receptacles 260 are formed here as a chimney-like, cylindrical structures which have a sufficiently large length to accommodate the respective container in full length. While the container receptacles of the first embodiment were formed integrally with the base body 210, the container receptacles 260 of the second embodiment are formed separately from the base body 210 and connected thereto through a suitable connection, e.g. B. a welding connection connected.
  • The respective inlet opening 213 in the base body 210 in this embodiment has a larger diameter than in the first embodiment. The container receptacle 260 has a bottom 264 from which a pin 265 extends into the inlet opening 213. A passage opening 266 through bottom 264 and pin 265 connects between the withdrawal channel of the piercing member 230 and the fluid channel in the base body 210, the piercing member 230 being inserted into a region of the enlarged diameter passage opening 266 and having a lower edge on a stop edge 267 is seated.
  • From the outer edge of the bottom 264 extends a cylindrical shell wall 261 up. In addition, extends from the bottom 264 of a part-cylindrical apron-like cover down, which partially surrounds the base body 210 laterally and in particular covers the insertion opening 216 for the insert element 250.
  • In the jacket wall 261, in each case a latching structure 262, 263 is formed on two opposite sides. The first latching structure 262 lies further away from the base body 210 than the second latching structure 263. Each of the latching structures comprises a spring arm, at the free end of a latching lug is formed, which extends into the interior of the container receptacle 260 inside. The second latching structure 263 is arranged so that it fixes the container 300 in a completely inserted removal position in which the piercing member 230 has pierced the closure 220 by a latching connection. For this purpose, the latching lug of the second latching structure 263 engages in the region of the taper 313 of the container body and thus prevents retraction of the container from the container receptacle. In contrast, the first latching structure 262 fixes the container to the container receptacle when the container is in a storage position in which the closure 320 is arranged at a certain distance from the tip of the piercing member 230. On the one hand, the first latching structure 262 on the one hand prevents the container 300 from being pulled out, on the other hand this latching structure also impedes further movement of the container 300 in the direction of the piercing member 230. In order to advance the container further in the direction of the piercing member 230 and thus puncture the closure, must an increased force is expended. About an away from the base body inclined surface is pressed by this increased force, the locking lug to the outside and releases the container for further movement.
  • In this way it is possible to store the containers on the filling device without the closures of the containers being able to be accidentally punctured or the containers falling out of the device.
  • Of course, a variety of modifications is possible. Thus, the container receptacles may be formed in a different manner than in the manner shown here. In particular, it is conceivable that a single container receptacle receives both containers together, for. B. in the manner of a common hood for both Container. It is also conceivable that the containers are held in a holding structure, and that the holding structure with the containers inserted therein is completely inserted into a corresponding container receptacle, as for example in some embodiments of the already mentioned US 6,488,650 the case is. Of course, it is also conceivable that a latching does not take place directly between the container receptacle and the respective container, but that such a latching takes place between the container receptacle and the holding structure inserted therein.
  • Instead of an applicator of the type specified here, of course, other types of applicators can be used, in particular applicators, as in WO 2009/144085 or WO 2007/109915 are illustrated. Conventional double syringes or unit-connected individual syringes can also be used. Accordingly, it is also possible to design the applicator according to different. In particular, of course, the distance of the outlet openings differently, in particular larger, can be selected as needed, as in the embodiments illustrated here. While the type of attachment of the applicator to the filling device shown here is advantageous, another type of connection between the filling device and the applicator can also be selected, for example a conventional luer connection.
  • Such a filling device can also be used for filling different types of reservoirs from containers with a pierceable closure. Thus, it is conceivable in particular for so-called cartridges (containers with septum closure and displaceable piston) to be used instead of the vials illustrated above. In this case, instead of an applicator, another type of accessory may be connected, e.g. a mixer to mix the contents of two cartridges. Also in this case, it is advantageous if the loss volume is reduced by using an insert element of the type mentioned, and / or if the carpules can be kept spaced from the piercing member by using suitable latching structures.
  • A variety of other modifications is possible, and the invention is by no means limited to the embodiments described above.
  • LIST OF REFERENCE NUMBERS
  • 100 applicator 233 removal channel 110 applicator 240 Applikatoranschluss 111 first reservoir 241 reception area 112 second reservoir 242 Codierflügel 113 retaining flange 243 pressure wings 114 Codierflügel 250 insert element 115 latching lug 251 first ring groove 116 first outlet 252 second annular groove 117 second outlet 253 longitudinal groove 120 piston unit 254 torus 121 first piston 260 container receptacle 122 second piston 261 shell wall 123 actuating surface 262 first latching structure 124 poetry 263 second latching structure 200 filling 264 ground 210 base body 265 spigot 211 thickening 266 Port 212 support plate 267 stop edge 213 inlet port 268 cover 214 outlet 300 container 215 ring groove 310 container body 216 insertion 311 ground 220 container receptacle 312 shell wall 230 Piercing body 313 rejuvenation 231 top 320 shutter 232 removal opening 321 septum

Claims (14)

  1. A device for removing a fluid from at least one container, the device comprising:
    a basic body (210) with an upper side and an underside in which at least one fluid channel of constant or variable cross-section running in a longitudinal direction is formed, the upper side of the basic body (210) being provided with an inlet opening (213) which runs at an angle to the fluid channel and opens into the fluid channel, and the underside of the basic body (210) being provided with at least one outlet opening (214) which runs at an angle to the fluid channel and opens out of the fluid channel at a point longitudinally offset from the inlet opening (213);
    at least one container connector (220; 260) for connecting a container to the inlet opening (213),
    wherein the basic body (210) is provided with at least one insert opening (216) which runs in the longitudinal direction and opens into the fluid channel, and
    wherein the device comprises at least one insert element (250) which is inserted into the fluid channel through the insert opening (216) and which reduces the cross-section of the fluid channel in a region between the inlet opening (213) and the outlet opening (214),
    characterised in that at least a portion of the fluid channel and the insert element (250) widen conically towards the inlet opening.
  2. The device in accordance with claim 1, wherein the insert element (25) is in the form of a peg extending along the longitudinal axis.
  3. The device in accordance with claim 1 or 2, wherein the insert element (250) has a circumferential surface which between the inlet opening (213) and the outlet opening (214) is essentially in sealing contact with a defining wall of the fluid channel, wherein a first annular groove (251) is formed in the circumferential surface of the insert element (250) close to the inlet opening (213) which at least partially extends around the insert element (250), wherein a second annular groove (252) is formed in the circumferential surface close to the outlet opening (214) which at least partially extends around the insert element (250), and wherein a fluid connection is provided between the first annular groove (251) and the second annular groove (252).
  4. The device in accordance with any one of the preceding claims, wherein the insert element (250) has a circumferential surface which between the inlet opening (213) and the outlet opening (214) adjoins a defining wall of the fluid channel in an essentially sealing manner, and wherein in the circumferential surface a flattened area and/or a connection groove (253) with a constant or variable cross-section is provided which creates a fluid connection between the inlet opening (213) and the outlet opening (214).
  5. The device in accordance with any one of the preceding claims, wherein a first catch structure (254) is provided on the insert element and a complementary second catch structure (215) is provided on the basic body, and wherein these catch structures interact with each other to hold the insert element (250) in the basic body (210).
  6. The device in accordance with claim 5, wherein the first catch structure (254) comprises an annular bulge on the insert element (250) and the second catch structure (215) comprises a complementary annular groove in a jacket wall of the fluid channel or of the insert opening.
  7. The device in accordance with any one of the preceding claims for filling at least one reservoir (111) of an applicator (100), wherein the device comprises an applicator connector (240) for connecting the reservoir (111) of the applicator (100) to the outlet opening (214).
  8. The device in accordance with claim 8, wherein the applicator connector (240) is made in one piece with the basic body (210).
  9. The device in accordance with any one of the preceding claims for the simultaneous removal of fluids from at least two containers (300),
    wherein in the basic body (210) a longitudinally running second fluid channel of constant or variable cross section is provided, wherein the upper side of the basic body is provided with a second inlet opening which runs at an angle to the second fluid channel and opens into the second fluid channel, and wherein the underside of the basic body is provided with a second outlet opening which runs at an angle to the second fluid channel and opens out of the second fluid channel at a point longitudinally offset from the inlet opening;
    wherein the device comprises a second container connector for connecting a second container to the second inlet opening,
    wherein the basic body is provided with a longitudinally running second insert opening facing away from the first insert opening and opening into the second fluid channel, and
    wherein the device has a second insert element which is inserted into the second fluid channel through the second insert opening and which reduces the cross-section of the second fluid channel in an area between the second inlet opening and the second outlet opening (214).
  10. The device in accordance with any one of the preceding claims, wherein in the area of the container connector (220) the device (200) comprises a hollow-needle-type puncturing element (230) connected to the inlet opening for puncturing a seal (320) of the container (300).
  11. The device in accordance with claim 10, the device comprising a container holder (260) connected to the basic body (210) for holding the container (300) on the device, and wherein the container holder (260) has a first catch structure (262) for fixing the container (300) on the container holder (260) in a storage position, in which the container (300) is further from the basic body (210) than in the removal position, by way of a releasable snap connection.
  12. The device in accordance with claim 11, wherein the container holder (260) further has a second catch structure (263) for fixing the container (300) on the container holder (260) in the removal position by way of a snap connection.
  13. The device in accordance with claim 11 or 12, wherein the container holder (260) has a preferably at least partially cylindrical jacket wall (261) and wherein the first catch structure (262) and the second catch structure (263) each comprise a spring arm, which is formed in the jacket wall and at the free end of which a catch lug extending into the jacket wall is formed.
  14. The device in accordance with any one of claims 11-13, wherein the container holder (260) has a base (264) from which a peg (265) extends into the inlet opening (213) of the basic body (210), with an inlet opening (266) being formed through the peg (265) and the base (264), and wherein the puncturing element (230) is held in the inlet opening (266).
EP20100801102 2010-02-01 2010-12-16 Device for removing fluids from vials Expired - Fee Related EP2531165B1 (en)

Priority Applications (2)

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CH1152010 2010-02-01
PCT/CH2010/000314 WO2011091543A2 (en) 2010-02-01 2010-12-16 Device for removing fluids from vials

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EP2531165B1 true EP2531165B1 (en) 2013-11-20

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WO2011091543A3 (en) 2012-08-16
WO2011091543A2 (en) 2011-08-04
WO2011091542A1 (en) 2011-08-04
CN102791241A (en) 2012-11-21
EP2531164A1 (en) 2012-12-12
EP2531165A2 (en) 2012-12-12
CN102770110A (en) 2012-11-07
EP2531164B1 (en) 2014-05-21
US20120298254A1 (en) 2012-11-29
US20120302986A1 (en) 2012-11-29
CN102791241B (en) 2015-04-08
US9402787B2 (en) 2016-08-02
CN102770110B (en) 2015-09-16

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