EP2442727A1 - Dispositif de remplissage d'une seringue multiple ou simple - Google Patents

Dispositif de remplissage d'une seringue multiple ou simple

Info

Publication number
EP2442727A1
EP2442727A1 EP09775086A EP09775086A EP2442727A1 EP 2442727 A1 EP2442727 A1 EP 2442727A1 EP 09775086 A EP09775086 A EP 09775086A EP 09775086 A EP09775086 A EP 09775086A EP 2442727 A1 EP2442727 A1 EP 2442727A1
Authority
EP
European Patent Office
Prior art keywords
base body
filling device
syringe
actuating element
cavity
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP09775086A
Other languages
German (de)
English (en)
Inventor
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
Application filed by Medmix Systems AG filed Critical Medmix Systems AG
Publication of EP2442727A1 publication Critical patent/EP2442727A1/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00491Surgical glue applicators
    • 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
    • A61J1/06Ampoules or carpules
    • A61J1/065Rigid ampoules, e.g. glass ampoules
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2096Combination of a vial and a syringe for transferring or mixing their contents
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B67OPENING, CLOSING OR CLEANING BOTTLES, JARS OR SIMILAR CONTAINERS; LIQUID HANDLING
    • B67BAPPLYING CLOSURE MEMBERS TO BOTTLES JARS, OR SIMILAR CONTAINERS; OPENING CLOSED CONTAINERS
    • B67B7/00Hand- or power-operated devices for opening closed containers
    • B67B7/92Hand- or power-operated devices for opening closed containers by breaking, e.g. for ampoules
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00491Surgical glue applicators
    • A61B2017/00495Surgical glue applicators for two-component glue
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/03Automatic limiting or abutting means, e.g. for safety
    • A61B2090/037Automatic limiting or abutting means, e.g. for safety with a frangible part, e.g. by reduced diameter
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2006Piercing means
    • A61J1/201Piercing means having one piercing end
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2079Filtering means
    • A61J1/2086Filtering means for fluid filtration
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/1782Devices aiding filling of syringes in situ
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/19Syringes having more than one chamber, e.g. including a manifold coupling two parallelly aligned syringes through separate channels to a common discharge assembly

Definitions

  • the present invention relates to a filling device for infesting a single or multiple syringe from at least one ampoule with at least one fluid.
  • 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 production of a multi-component bone cement.
  • Medicines made by mixing two or more components, but when mixed, they can not be stored. In this case, it is desirable to first store the components separately and to mix them just prior to their administration. Similar objects also arise in other pharmaceutical or chemical systems of two or more components that are not stable in the mixed state.
  • a device for breaking a single ampoule in which the ampoule is inserted longitudinally into a sleeve in which a ramp is formed. When inserted, the ramp exerts a lateral force on the ampoule tip, which shears the tip of the ampoule. Subsequently, the ampoule is removed from the sleeve and can now be emptied. With such a device, however, it is not possible to fill a syringe directly. This is unsatisfactory in terms of hygiene. In addition, there is a risk of spillage and injury to the sharp breakage when handling the open vial.
  • WO 99/37256 discloses in Figures 7 and 8 a bone cement mixer into which an ampoule can be inserted. To open the ampoule tip is destroyed with a laterally insertable metal pin. However, this device is not suitable because of its construction to transfer the contents of the ampoule into a syringe.
  • a device is provided with which the filling of a multiple syringe from ampoules can be carried out easily and cleanly.
  • Such a device is specified in claim 1.
  • Advantageous embodiments are given in the dependent claims.
  • a base body defining at least a first and a second lumen having a proximal end and a distal end, each of the lumens defining a longitudinal direction and having a removal opening at its distal end for withdrawing fluid from the lumen; a first port communicating with the removal port of the first lumen and a second port communicating with the withdrawal port of the second lumen, the first port and the second port configured to cooperate with complementary ports of a multiple syringe; and a crushing device adapted to break a first vial disposed in the first cavity and a second vial arranged in the second void simultaneously or sequentially by a single actuating movement.
  • ampoules typically have a substantially cylindrical ampoule body, a closed tip and a tapered ampoule neck disposed between the ampoule body and tip, which acts as a predetermined breaking point and where the ampoule can be broken to remove the contents.
  • ampoules are made of glass, but in principle can also consist of special, relatively brittle plastics.
  • the distal direction refers to the direction in which a fluid is released from the Be GlaUvorides into the double syringe into it.
  • the proximal direction is accordingly called the opposite direction.
  • one ampoule with the tip can be inserted in the longitudinal direction through the open proximal end of one of the cavities into the Be SchoUvorraum.
  • the Voids preferably extend substantially parallel to one another and define a common longitudinal direction. They preferably have a substantially cylindrical basic shape, in particular a substantially cylindrical inner contour.
  • the breaking device preferably comprises an actuating element which is movable relative to the base body and which is designed to act on the ampoules arranged in the cavities by a single movement of the actuating element along an actuating direction.
  • the movement of the actuating element in the longitudinal direction can take place, while in other embodiments, the actuating direction obliquely or transversely to the longitudinal direction, in particular perpendicular thereto, runs.
  • the movement of the actuating element takes place from a starting position, in which the ampoules are closed, into an actuating position in which the ampoules are opened.
  • the actuating element is preferably displaceable relative to the base body in order to break the ampoules, preferably by a pure translational movement.
  • the actuating element carries out a more complex movement, which comprises a rotation, e.g. a screw movement or a bow movement, or a movement with several different movement phases, e.g. to unlock the actuator first.
  • the actuating element is sealed relative to the base body. This prevents the fluids from leaking out of the cavities after fracturing or mixing in the inflator.
  • the base body can also be designed so that the ampoules can be inserted sealingly in the base body, and for this purpose a sealing structure, e.g. an annular taper, or a sealing element, e.g. a sealing ring, have.
  • each removal port is provided with a filter to retain solids in the respective cavity.
  • the actuating element and / or the base body on a retaining structure, which prevents the actuating element can be withdrawn after actuation from the operating position back to the starting position.
  • the cavities are substantially parallel to one another and define a common longitudinal direction.
  • a ramp is formed, which is inclined to the longitudinal direction, and the actuating element is movable relative to the base body along the longitudinal direction and adapted to press each of the ampoules with its distal end against each one of the ramps, to the ampoules To generate at their distal ends a force component perpendicular to the longitudinal direction. In this way, the distal end of the ampoules can be sheared off. If the ampule has an ampule body and a tip connected to the ampule body via a tapered taper, this will cause the ampule to break at the taper.
  • the ampoules are preferably held in the actuator.
  • the actuating element has a first and a second holding region in order to respectively hold an ampoule with its proximal end, in particular by frictional forces.
  • the ampoules can be inserted in particular with their proximal ends in the holding areas.
  • the actuating element, in particular the holding regions, each with an ampoule held therein can be inserted along the longitudinal direction into the cavities in order to push the ampoules onto the ramps.
  • the actuating element can be pushed onto the base body, so that the actuating element at least partially surrounds the base body in a pushed-on state.
  • locking means On the base body and on the actuating element locking means are preferably formed, which cause a latching connection between the base body and the actuating element at least in an end position in which the actuating element has reached a distal end position.
  • the locking means also cause in a starting position in which the ampoules are still intact, a releasable locking connection, so as to create a defined starting position.
  • the locking means are designed such that they at least in the starting position, a movement of the
  • the actuator is slidable along an actuation direction into the cavities that is oblique or transverse to the longitudinal direction so that the actuator exerts a force component perpendicular to the longitudinal direction on a distal end region of each of the ampoules.
  • the actuating element may have at least two interconnected, mutually parallel crushing structures (in particular bolts), which can be inserted through lateral openings of the base body into the cavities.
  • the crushing structures are preferably sealed off from the base body. They preferably each have a free end, on each of which an inclined surface is formed which extends obliquely to the actuating direction.
  • the crushing structures apply to the distal ends of the ampoules a force having a component acting both perpendicular to the longitudinal direction and perpendicular to the actuating direction.
  • the crushing structures can also press directly along their direction of insertion against the distal end region of each of the ampoules and thus shearing off or smashing this end region during insertion.
  • the crushing structures may each be formed blunt (eg flat or rounded) or tapering at their end which can be inserted into the cavity.
  • the actuating element comprises a guide portion, which is insertable into a complementary guide structure of the base body to the
  • Guide structure act on another opening on the base body, in which the guide area is inserted.
  • this opening preferably does not open into one of the cavities for the ampoules.
  • the invention also relates to the combination of a filling device according to one of the preceding claims and a multiple syringe, in particular a double syringe, wherein the multiple syringe comprises at least a first and a second syringe body having a cylindrical wall portion, a top wall, an outlet disposed in the top wall and a port communicating with the outlet; at least a first and a second syringe plunger, wherein each of the syringe plungers is sealingly displaceable in the cylindrical wall region of one of the syringe bodies; an actuator connecting the first and second syringe pistons to simultaneously move both syringe plungers, each of the syringe body ports being connectable to a complementary port of the filling device.
  • a method for filling a multiple syringe with at least two syringe bodies from at least two ampoules is specified, with the following steps:
  • the present invention provides a device with which a single container, in particular a single syringe, can be filled in a simple and secure manner from at least one ampoule.
  • a single container in particular a single syringe
  • Such a device is specified in claim 15.
  • Advantageous embodiments of this device are specified in the subsequent dependent claims.
  • a filling device for filling a container with a fluid from at least one ampoule.
  • This has a base body, which forms at least one longitudinal cavity extending along a first cavity having a proximal end and a distal end.
  • the base body is designed to receive an ampoule sealingly in the first cavity, at least with its distal end. It has a removal opening in the region of the distal end of the cavity in order to remove a fluid from the cavity, and a connection which communicates with the receiving opening and is designed to cooperate with a complementary connection piece of a container.
  • the filling device also has an opening device, which is designed to to open an ampoule arranged in the first cavity.
  • the opening device comprises an actuating element which can be inserted into the base body along an actuating direction in order to shave or shatter a distal end region of an ampoule intended for use in the base body, the actuating direction being angled (obliquely or transversely) to the longitudinal direction.
  • the actuating element thus produces a force component acting transversely to the longitudinal direction on a distal end region of the ampoule.
  • the actuation direction preferably runs at an angle of substantially 90 ° to the longitudinal direction. The actuation takes place from a starting position into an inserted operating position.
  • the actuator is inserted by a pure translational movement along the operating direction in the base body to open the ampoule.
  • the insertion movement of the actuating element can also extend along an arcuate path, wherein the central axis of the arc movement (in the case of a pivoting movement so the pivot axis) but preferably not coincides with the central center axis of the cavity in which the ampoule is received.
  • the actuating element is preferably insertable into an opening-near, distal end region of the cavity, which is closer to the distal end of the cavity with the removal opening than to the proximal end of the cavity.
  • the actuating element is preferably sealed off from the base body.
  • the base body towards the cavity on a Betjansöfmung and the actuating element has a crushing structure, which is inserted through the Betreli whysöfmung in the cavity of the base body to open the ampoule.
  • a seal is formed in the region of the actuating opening between the crushing structure and the base body.
  • the actuator may be configured to shatter the distal end portion of the ampule.
  • the actuating element may have a break-up structure which, upon insertion of the actuating element into the base body, moves into the cavity, in particular its distal end area, in such a way that it moves End portion of a designated held in the base body ampoule smashed.
  • the crushing structure can protrude in the inserted state substantially centrally into the cavity.
  • the actuator may be configured to shear the distal end portion of the ampule.
  • the actuating element can again have a break-up structure which can be inserted into the cavity with one end, in particular in its distal end region.
  • an inclined surface may be formed, which extends obliquely to the actuating direction, to apply a shear force on an end region of an ampoule intended to be held in the base element which acts at an angle to the longitudinal direction and angled to the actuating direction.
  • an additional guide structure for the actuating element can be formed on the base body in order to achieve this
  • the guide structure may have at least one guide opening which runs parallel to the actuation opening, and the actuation element may have a complementary guide area, e.g. one
  • Guide pin which can be inserted into the ceremoniessöffhung to guide the actuator on the base body.
  • the guide opening preferably does not open into the cavity for the ampoule.
  • a retaining structure may be formed, which prevents the actuating element in its operating position from being pulled out again.
  • at least one resilient or resilient locking lug be present, which cooperates in the inserted state with an edge of the respective other element and so causes a latching connection.
  • the filling device is for filling a single container, in particular a single syringe, with a single fluid from a single ampoule.
  • the base body defines exactly one cavity for receiving exactly one ampoule.
  • the base body also defines at least one second cavity with a proximal end and a distal end, the base body is designed to sealing at least a second ampoule at least with its distal end in the second
  • the base body has a second Entjoffiiung to remove fluid from the second cavity.
  • the first and second cavities then run substantially parallel to one another and define a common longitudinal direction.
  • the actuating element then preferably comprises at least two interconnected, mutually parallel crushing structures, which are inserted along the actuating direction in Betuschistsöffhungen the base body to shear or shatter distal end portions of arranged in the base body ampoules.
  • at least two ampoules can be opened by a single actuation movement.
  • at least two separate actuating elements can be present, which can be actuated separately in order to break one ampoule each.
  • the present invention also relates to a combination of a filling device of said type and a syringe, the syringe comprising: at least one first syringe body having a cylindrical wall portion, a top wall, an outlet disposed in the top wall, and a fitting communicating with the outlet; at least one first syringe plunger which is sealingly displaceable in the cylindrical wall region of the syringe body; wherein the connector of the syringe body is connectable to a complementary port of the Befullvorraum.
  • Fig. 1 shows an exploded view of a filling
  • Breaking device according to a first embodiment, together with a double syringe
  • Fig. 2 shows a view of the Befullvorraum and double syringe of Figure 1 in the assembled state before the operation of the crushing device.
  • Fig. 3 shows a central longitudinal section through the Befullvorraum of Figure 1 in the assembled state before the operation of the crushing device.
  • Fig. 4 shows a longitudinal section in the plane IV-IV of Fig. 3;
  • Fig. 5 shows a central longitudinal section through the Befullvortechnik of Figure 1 in the assembled state after the operation of the crushing device, but before filling the double syringe.
  • Fig. 6 shows a central longitudinal section through the Befullvortechnik of FIG. 1 in the assembled state after filling the double syringe.
  • Fig. 7 shows an exploded view of a Befullvorraum with
  • Fig. 8 shows a view of the Befullvorplatz and double syringe of Figure 7 in the assembled state before the operation of the crushing device.
  • Fig. 9 shows a central longitudinal section through the Befullvortechnik of Fig. 7 in the assembled state before the operation of the crushing device.
  • FIG. 11 shows a view of the filling device and double syringe of Figure 10 in the assembled state before the operation of the crushing device.
  • Fig. 12 shows a central longitudinal section through the Berullvorraum of Figure 10 in the assembled state before the operation of the crushing device.
  • Fig. 13 shows a longitudinal section in the plane XIII-XIII of Fig. 12;
  • Fig. 14 shows a cross section in the plane XIV-XIV of Fig. 12;
  • Fig. 15 shows a central longitudinal section through the filling device of Figure 10 in the assembled state after the operation of the crushing device, but before filling the double syringe.
  • Fig. 16 shows a longitudinal section in the plane XVI-XVI of Fig. 12;
  • FIG. 17 shows a central longitudinal section through the filling device of FIG. 10 in the assembled state after filling of the double syringe.
  • Fig. 18 shows an exploded view of a filling device
  • FIG. 19 shows a central longitudinal section through the filling device of Figure 18 in the assembled state before the operation of the crushing device.
  • Fig. 20 shows a cross-section in the plane XX-XX of Fig. 19;
  • Fig. 21 shows a view of the filling device and double syringe of Fig. 18 in the assembled state before the operation of the crushing device.
  • Fig. 22 shows an exploded view of a filling device
  • FIG. 23 shows a central longitudinal section through the filling device of FIG. 22 in the assembled state before the operation of the breaking device
  • Fig. 24 shows a cross section in the plane XX-XX of Fig. 23; and Fig. 25 shows a view of the filling device and double syringe of Fig. 22 in the assembled state before the operation of the crushing device.
  • Fig. 26 shows an exploded view of a filling device
  • Crusher according to a sixth embodiment, together with a single syringe
  • Fig. 27 is a rear view of the filling apparatus of Fig. 26; Fig. 28 shows a central longitudinal section in the plane XXVIII-XXVIII through the
  • FIG. 29 shows a partial view of a longitudinal section through the filling device of FIG
  • Fig. 30 shows a cross section of the filling device of Fig. 26 in the plane XXX-XXX;
  • FIG. 31 shows a central longitudinal section of the filling device according to FIG.
  • Fig. 32 shows a partial view as in Fig. 29 after the actuation of
  • FIG. 33 shows a cross section as in FIG. 30 after the actuation of the
  • FIGS. 1 to 6 show a first embodiment of a filling device 100 according to the invention with a double syringe 600 connected thereto.
  • the double syringe 600 comprises a main body 610 with a first and a second cylindrical syringe body 611, 612, which are arranged parallel to one another. At the front ends of the syringe body fittings 613, 614 are formed, in the present example in the form of male Lueranêtn. At the back end the two syringe bodies 611, 612 are connected by a connecting plate 615.
  • a double piston 620 is inserted in the main body 610. This comprises two syringe plungers 621, 622, which are connected to one another via two parallel piston rods 623, 624 and an actuating flange 625 connecting the piston rods.
  • the filling device comprises a base body 110 with two parallel receiving areas 111, 112 of cylindrical basic shape, which are interconnected at their distal ends by a connecting plate 117. Each of the two receiving regions 111, 112 defines a cavity 115, 116.
  • two ports 113, 114 are formed for connection to the double syringe. These ports can be coded, i. they may be differently marked or formed so that the dual syringe 600 can be secured to the terminals 113, 114 only in a predetermined orientation, e.g. by different shape or dimensions. In the present example, however, both terminals are formed as identical female Luer connectors.
  • Each of the ports 113, 114 communicates via a removal opening with one of the cavities 115, 116 in connection.
  • a cylindrical filter 710 is used in each case (FIG. 3), which serves to retain solids in the cavity. This may be e.g. to act a sintered filter that can be pressed into the opening.
  • a wedge-shaped structure 118 is formed in the interior of each of the two receiving regions 111, 112, which is arranged laterally offset from the respective longitudinal axis and at its proximal end has a tilting in the distal direction to the longitudinal axis , narrow slanted surface or ramp forms.
  • the wedge-shaped structure 118 is spaced from the mantle wall of the respective Aufhahme Suites arranged so that a partially annular gap 119 remains between the shell wall and the wedge-shaped structure 118.
  • the filling device 100 further comprises an actuator 120 adapted to hold two ampoules 700 and insert them into the base body 110 to break the ampoules.
  • the actuating element 120 has two cylindrical holding regions 121, 122 arranged in parallel, which are connected at their proximal ends by a connecting plate 123.
  • 122 holding structures 124 in the form of at least three longitudinally extending ribs having at its distal end inwardly projecting, tapered retaining lugs.
  • the holding regions in the radial direction yield so far that the ampoule body can slide between the retaining lugs.
  • the vial When the vial is fully inserted, it abuts a stop 125 at the proximal end. In this position, the retaining lugs come to lie in the region of the taper 703 of the ampoule 700 and thereby keep this in the retracted position.
  • the two cylindrical holding regions 121, 122 of the actuating element 120 can be inserted with the ampoules received therein into the cavities 115, 116 of the base body 110 in the longitudinal direction.
  • a seal between the base body 110 and the actuating element 120 is formed by a respective sealing ring 134 is formed on the outside of the cylindrical lateral surfaces of the holding portions 121, 122 near the respective distal end.
  • This sealing ring 134 is sealingly against the inner circumferential surface of the receiving areas 111, 112 of the base body and thus produces a liquid-tight seal.
  • a latching lug 133 which is chamfered in the distal direction.
  • two latching openings 131, 132 each are formed, which are arranged spaced from each other along the longitudinal direction.
  • the locking lug 133 slides out of the first Rastöflnung 131 thanks to its bevel, and the actuator 120 is further inserted into the base body 110.
  • the ampoules are pressed with their tips 702 against the inclined surfaces of the wedge-shaped structures 118. This creates a force component which acts perpendicular to the longitudinal direction and thereby causes the tips of the ampoules are broken off at the acting as predetermined breaking points tapers 703 from the ampoule body 701.
  • the cylindrical jacket wall of the respective holding region 121, 122 of the actuating element 120 slides with its distal end into the corresponding part-annular gap 119.
  • the locking lug 133 slides into the second Rastöffiiung 132 and causes a permanent locking of the actuating element 120 with the base body 110, a retraction of the actuating element 120 prevented. This is the situation of FIG. 5.
  • the contents of the ampoules can be emptied into the respective cavity and taken with the double syringe 600 in the two syringe bodies 611, 612 by the syringe plunger 621, 622 withdrawn via the piston rods 623, 624 and the actuating flange 625 become. This is illustrated in FIG. 6.
  • FIGS. 7 to 9. A second embodiment of a filling device is shown in FIGS. 7 to 9. Identical parts are designated by the same reference numerals as in the first embodiment.
  • the filling device 200 in turn comprises a base body 210 and an actuating element 220.
  • the base body 210 in turn comprises two parallel, cylindrical receiving areas 211, 212, which are interconnected by a connecting plate 217. Again, the receiving areas 211, 212 define two cavities 215, 216, which open into ports 213, 214 through corresponding removal openings.
  • the actuating element 220 again comprises two parallel, cylindrical holding portions 221, 222, which in turn are connected by a connecting plate 223.
  • Retaining structures 224 and a stop 225 are again formed in the interior of the holding regions 221, 222 in order to receive and hold one ampoule 700 in each holding region.
  • the support structures 224 are again formed as longitudinally extending ribs. However, these are shorter than in the first embodiment and have no retention nose at their distal end.
  • the actuating element in the second embodiment is not inserted into the base body, but is pushed onto the base body, so that the cylindrical side wall portions of the holding portions 221, 222 surrounding the Aumahme Suitee 211, 212 of the base body in its proximal region.
  • a seal is formed between the base body 210 and the actuating element 220.
  • the seal is formed by a respective sealing ring 234 on the outer circumferential surface of each Aumahme Suites 211, 212.
  • a latching nose 233 is formed on the outer lateral surfaces of the receiving regions 211, 212 of the base body 210, which has latching openings 231, 232 in the lateral surfaces of the holding regions 221, 222 the actuating element 220 cooperates.
  • this device is substantially the same as that of the first embodiment.
  • a wedge-shaped structure 218 is formed inside each of the base bodies 210 in each of the receiving regions 211, 212, forming an inclined surface or ramp onto which the tip 702 of the respective ampoule is slid to laterally shear the tip.
  • the actuating element 220 in this embodiment is pushed onto the base body 210 instead of being pushed into it, a partially annular gap between the wedge-shaped structure 218 and the respective jacket wall can be omitted here.
  • FIGS. 10 to 17 show a third embodiment of a filling device.
  • the operation is not in the longitudinal direction, but in the transverse direction.
  • a force component is generated which acts perpendicular to the longitudinal direction in order to break off the ampule tips from the ampule bodies.
  • the filling device 300 in turn comprises a base body 310 with two parallel receiving areas 311, 312 which delimit two cavities 315, 316 and open into ports 313, 314. Two ampoules 700 are fully insertable into the receiving areas.
  • the base body 310 can then be sealed by a cover 330 with two plugs 331, 332, which are connected via a cover plate 333, sealing.
  • a lateral opening 318, 319 is respectively formed in the region of its distal end. Between these openings is a hollow cylindrical Fügnmgspatented 317, the cylinder axis extends in the transverse direction and which is also open at the side.
  • an actuating element 320 can be inserted laterally.
  • This comprises a pushbutton-like actuating region 324, a cylindrical guide region 323 which is complementary to the guide structure 317, and two parallel bolts 321, 322, which act as crushing structures and can be inserted through the lateral openings 318, 319 into the cavities 315, 316.
  • FIGS. 11 to 14 a starting position is illustrated in which the Actuator 320 is indeed inserted into the base body 310, but has not been operated to open the ampoules.
  • inclined surfaces or ramps are formed, which are inclined to the transverse direction. These ramps are free of force at the tips 702 of the ampoules 700 or have a certain, small distance from these tips.
  • FIGS. 15 and 16 illustrate how the actuation element 320 for breaking the ampoules has been inserted further.
  • the ramps of the bolts 321, 322 now have the tips 702 of the ampules 700 laterally pressed away in a direction transverse to the direction of actuation and to the longitudinal direction.
  • the ampoules are broken in the region of their rejuvenation 703 acting as predetermined breaking points.
  • the liquid contained in the ampoules can now be received in the two syringe bodies of the double syringe 600.
  • FIGS. 18 to 21 A fourth embodiment is illustrated in FIGS. 18 to 21.
  • the filling device 400 of this embodiment is fundamentally similar to the filling device of the third embodiment (base body 410, receiving areas 411, 412, ports 413, 414, cavities 415, 416, transversely insertable actuator 420, lid 430).
  • lateral openings 418, 419 are provided, through which bolts 421, 422 of the actuating element 420 can be inserted.
  • These are provided with ramps at their ends as in the third embodiment and thereby act on the ampoules in the same way as we in the third embodiment.
  • the actuator 420 is defined by a T-shaped guide portion 423 in a corresponding complementary guide structure 417 led to the base body 410.
  • the actuating region 424 is embodied here rectangular and is received in the end position in a corresponding rectangular frame of the base body 410.
  • a fifth embodiment is illustrated in Figs. 22-25.
  • the filling device 500 of this embodiment is basically similar to that of the third embodiment (base body 510, receiving portions 511, 512, terminals 513, 514, cavities 515, 516, transversely insertable operating member 520, lid 530).
  • the side openings 518, 519 for insertion of the actuating element 520 are here executed schzylinderf ⁇ rmig.
  • the actuating element has correspondingly semi-cylindrical bolts 521, 522, which are connected by a circular actuating region 524 and at the ends of which a respective narrow ramp 526 is formed on a guide plate 525 extending the cut surfaces of the half-cylinder.
  • FIGS. 26 to 33 A sixth embodiment is illustrated in FIGS. 26 to 33.
  • the filling device 800 is designed to fill a single syringe 600 'from a single ampule 700.
  • the filling device 800 comprises a base body 810, which has a cylindrical receiving area 811 for the ampoule 700.
  • the base body 810 defines with the receiving area 811 a cavity 812 for receiving the ampoule. With its cylinder axis, the cavity defines a longitudinal direction.
  • the cavity 812 can be closed by a cover 830 with a sealing skirt 831, which can be inserted into the cavity 812, and the cover wall 832.
  • the cavity opens at its distal end into an outlet in which a filter 710 ( Figure 28) is located and which communicates with a port 813 for the syringe 600 '.
  • the connection is in turn designed as a female Luer connection, but can also be designed as a male Luer connection or in another form.
  • a guide structure 816 is formed laterally on the base body 810. This has a lateral opening 814 which opens into a distal end region of the cavity 812. Parallel to this run two holes or mecanicsöffhungen 815, which have no connection to the cavity 812.
  • an actuating element 820 can be inserted.
  • This has a crushing structure in the form of a cylindrical bolt 821, which is einschreibbar with its free end in the lateral opening 814 of the base body. At this end of the bolt 821 is flat, but may also be oblique or tapered, in particular pointed, be formed.
  • Parallel to the bolt 821 extend two guide pins 823, which are inserted into the two Fübxungsöffiiitch 815.
  • the guide pins are longitudinally slotted and have forwardly beveled locking lugs, which engage in the inserted state in corresponding stages in the ceremoniessöffhungen 815 (Fig. 29).
  • the ampule 700 is inserted into the cavity 812 of the filling device. Subsequently, the cavity is closed with the lid 830. Now, the syringe 600 'is connected with its connection piece 613' to the connection 813 of the filling device. This is the situation of Figs. 28-30.
  • the actuator 820 is now inserted.
  • the free end of the bolt 821 enters the distal end region of the cavity 812 in which the ampoule tip 702 is located and smashes it.
  • the actuating element 820 is additionally guided by the guide pins 823.
  • smashing the ampoule tip it is also conceivable to shear off the ampoule tip by an inclined surface or ramp. By shattering the ampoule tip is However, it is also possible to remove the contents of the ampoule tip, while a mere shearing a remainder of the content remains in the tip.
  • the contents of the ampoule pour now into the cavity and can be transferred through the Entddlingöffiiung in syringe 600 '.
  • the syringe body 610 ' is held in the usual manner by means of the holding flange 611', while the syringe plunger 620 'is pulled out of the syringe body 610'.
  • the base body is preferably made in one piece from plastic.
  • the actuator is preferably made in one piece.

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Abstract

La présente invention concerne un dispositif de remplissage (300) permettant de rompre le col d'au moins une ampoule (700) et de faire passer dans une seringue (600) le contenu de l'ampoule. Le dispositif de remplissage comporte un corps de base (310) définissant au moins un volume creux (315). L'extrémité distale de chaque volume creux comporte une ouverture de prélèvement reliée à un raccord (313) pour seringue multiple. L'invention comporte également un dispositif de rupture configuré pour rompre le col de l'ampoule placée dans le volume creux. Dans certains modes de réalisation, le dispositif de rupture est pourvu d'un élément actionneur chargé de pousser au moins deux ampoules en un seul mouvement longitudinal d'actionnement, chacune sur une structure en forme de coin, de façon à exercer sur la pointe de l'ampoule une force latérale. Dans d'autres modes de réalisation, le dispositif de rupture comporte un élément actionneur (320) perpendiculairement rétractable (320), qui vient agir sur la pointe de l'ampoule, pour fragmenter ou détacher cette pointe.
EP09775086A 2009-06-19 2009-12-17 Dispositif de remplissage d'une seringue multiple ou simple Withdrawn EP2442727A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CH9622009 2009-06-19
PCT/CH2009/000401 WO2010145041A1 (fr) 2009-06-19 2009-12-17 Dispositif de remplissage d'une seringue multiple ou simple

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US (1) US9131930B2 (fr)
EP (1) EP2442727A1 (fr)
CN (1) CN102458262A (fr)
WO (1) WO2010145041A1 (fr)

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WO2010145041A1 (fr) 2010-12-23
US20120055580A1 (en) 2012-03-08
US9131930B2 (en) 2015-09-15
CN102458262A (zh) 2012-05-16

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