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WO2011027207A1 - Dispositif d'application de médicaments fluides - Google Patents

Dispositif d'application de médicaments fluides Download PDF

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Publication number
WO2011027207A1
WO2011027207A1 PCT/IB2010/002167 IB2010002167W WO2011027207A1 WO 2011027207 A1 WO2011027207 A1 WO 2011027207A1 IB 2010002167 W IB2010002167 W IB 2010002167W WO 2011027207 A1 WO2011027207 A1 WO 2011027207A1
Authority
WO
WIPO (PCT)
Prior art keywords
housing part
connection
housing
reservoir
luer
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.)
Ceased
Application number
PCT/IB2010/002167
Other languages
German (de)
English (en)
Inventor
Jan Willem Marinus Mijers
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.)
Individual
Original Assignee
Individual
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 Individual filed Critical Individual
Publication of WO2011027207A1 publication Critical patent/WO2011027207A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2096—Combination of a vial and a syringe for transferring or mixing their contents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/22—Valves or arrangement of valves
    • A61M39/223—Multiway valves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2006—Piercing means
    • A61J1/201—Piercing means having one piercing end
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2048—Connecting means
    • A61J1/2058—Connecting means having multiple connecting ports
    • A61J1/2062—Connecting means having multiple connecting ports with directional valves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2068—Venting means
    • A61J1/2075—Venting means for external venting
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2079—Filtering means
    • A61J1/2082—Filtering means for gas filtration

Definitions

  • the invention relates to a device for applying fiuidalen drugs, in particular cytostatics, comprising an at least two-piece mutually rotatable housing having a plurality of terminals and at least one liquid receiving element, wherein a drug via the liquid receiving element at least from a first reservoir removable and a second container via a hose connection can be filled and wherein alternately a first passageway connects to a second passageway, a third passageway can be blocked in parallel, thereby preventing exposure of liquid to the environment.
  • cytostatics comprising an at least two-piece mutually rotatable housing having a plurality of terminals and at least one liquid receiving element, wherein a drug via the liquid receiving element at least from a first reservoir removable and a second container via a hose connection can be filled and wherein alternately a first passageway connects to a second passageway, a third passageway can be blocked in parallel, thereby preventing exposure of liquid to the environment.
  • a dilution solution is withdrawn from a corresponding container with a syringe and introduced into the container containing the drug.
  • a septum is usually present on a medication container, which is pierced with a needle of the syringe.
  • an injection device is then connected to the drug container or the containing dilution solution with drugs, using a syringe, removed from the drug container and injected the drug in solution.
  • a removal of a drug solution from a container via so-called “spikes” takes place, wherein a dilution solution with the aid of a spike, which usually has two tips, can enter the container usually below a container containing a dilution solution, so that an inflow of the dilution solution can take place via the mandrel into the container containing the medicament.
  • a removal of the prepared solution via the mandrel is possible, wherein a hose can establish a connection between the mandrel and an injection device, such as a needle. If the drug solution is withdrawn from the container via a syringe, an injection can then be made through the syringe at a suitable injection site.
  • the aforesaid route for diluting injectable medicaments by handling open, sharp objects such as the dome or the needle, creates an inherent danger of contamination of the environment which may come into contact with the drug.
  • This is of particular concern when the use of hazardous, such as toxic drugs is provided, such as in the context of the treatment of cancer with cytotoxic drugs.
  • the medical staff handling the medicines will be exposed to the danger that an exposure of the medicament will exert an effect on the organism whose treatment will result in an effect which will be effective in the therapeutic treatment of the medicament Patients should be counteracted.
  • exposure to cytotoxic agents may cause a carcinogenic effect on the medical staff, which should be avoided at all costs.
  • a hydrophobic filter which is capable of preventing both the passage of aerosols to the outside and the ingress of microorganisms inwardly.
  • such devices are not fully isolated, as conventional devices simultaneously connect both the diluent solution container and the medicament container and allow subsequent withdrawal of the drug solution.
  • a removal of the dissolved drug by another device, such as a syringe take place, which brings with it the risk of contamination of the drug with the environment.
  • devices are known from the prior art in which an application of medicaments is made possible, in which the medicament is located within an evacuated container, which is connected via a valve with a syringe containing a diluting solution.
  • the dilution solution is introduced into the evacuated container and the drug located there is dissolved in the dilution solution. After mixing the drug with the solution for injection via an adjustment of the valve position between the container and the syringe delivery of the drug solution to a desired injection site is possible without a re-puncturing a another container must be made.
  • the object of the invention is therefore to provide a device for the application of fluid medicaments which meets a high safety standard, has sufficient tightness to prevent contamination and is compatible with injection devices of the prior art.
  • the object is achieved in that the device consists of two housing parts, which have two inner corresponding housing walls, one of which is formed as a through hole and another cylindrical, wherein both are rotatably supported each other and the cylindrical housing at least a first at right angles in the radial direction extending flow channel and a second approximately 45 ° degrees to the radial direction extending flow channel, wherein the flow channels each open into a connection channel.
  • the device according to the invention has two corresponding housing parts, which are rotatably mounted one inside the other.
  • a housing part has a through hole as the inner housing wall
  • the second housing part has a cylindrical housing wall, which can be inserted into the through hole, so that a positive connection between the first and second housing part is formed.
  • the inner housing walls of the two housing parts are protected to the outside by an outer housing, which are also provided either for rotatably moving a housing part relative to the other housing part or for connecting storage containers and connecting hoses via corresponding connection elements.
  • the flow direction of the liquid (medicament) is determined via the inner housing walls.
  • the inner cylindrical housing wall of the first housing part has at least one first flow passage extending at right angles in the radial direction and a second flow passage extending approximately at 45 ° to the radial direction.
  • the two flow channels open into a connection, which is preferably integrally formed on the outer housing wall of the second housing part. Due to the possibility of rotation about a common axis of rotation of the two housing parts, it is thus possible to connect a first connection to a second connection alternately. the and in parallel to lock a third port. Thus, there is an influence on the direction of flow of the liquids to be picked up and forwarded, in particular of a fluidic medicament.
  • a liquid can thus pass alternately via the flow channels to the connections.
  • the other flow channel is closed in each case when both housing parts are rotated relative to one another by 90 ° and the previously blocked flow channel is opened and the open flow channel is closed.
  • a connection of two flow channels can be opened and closed, whereby a fluid with changing flow direction passes from one flow channel to another flow channel.
  • a controllable filling and / or removal of liquids from storage containers is possible, which can be connected to the device (three-way valve), wherein the filling and removal of liquids via the existing connections and a liquid receiving element is possible.
  • Reservoirs with liquids and / or containers for liquid absorption can be connected to the formed connections and the liquid absorption element directly or by adapters or hose connections, so that filling or removal of a liquid, depending on the position of the device, becomes possible from two interconnected containers, wherein Removal preferably a connectable to a port syringe is provided with which the liquid is sucked from a container, for example via an insertion mandrel, and after rotation of the device in another container, such as an infusion container, can be dispensed.
  • an overpressure can be generated, which is created by the fact that first sucked air via a filter unit with the help of the syringe and then discharged directly into the reservoir.
  • the removal of liquid from one or more storage containers is in this case several times possible, so that a mixing of drugs in liquid form can take place and thus, for example, by adding several liquids in a connected container, a drug cocktail can be supplied to the container.
  • the outer housing wall of a housing part has at least one Luer connection for the removal of a medicament from at least one storage container and a further Luer connection for the filling of a second container.
  • a piercing spike is used, which is formed directly connectable to the Luer connector and is additionally protected by a protective cap to avoid injury. After removal of the cap of this plug is inserted into the reservoir and remains in this reservoir until it is completely emptied.
  • a second luer connection for a syringe and a third luer connection for connection are provided which is connected directly to the device via a hose line with end-side luer screw connections.
  • the first housing part is constructed in two parts and protrudes at both ends of the housing part and merges into a hollow-walled turntable. Due to the two-part design of the housing part, it is possible to insert a first housing part into the existing through hole of the second housing part and then to place the second part of the first housing part on the protruding housing part.
  • the first housing part end consists of a respective hollow-walled turntable, which allows a manual handle of the three-way valve, in which the turntable can be further rotated stepwise at least in a preferred direction relative to the second housing part.
  • a first turntable is in this case integrally connected to the inner cylindrical housing wall, which has at its free end a rotary lock, for example a hexagon.
  • a second turntable is equipped with a corresponding lock, which can be fixed to the free end of the cylindrical housing by means of a clamp or screw. Consequently the first housing part can be inserted into the second housing part and connected by the two outer slewing rings in such a way that a captive assembly is formed.
  • the design of the two slewing rings also makes it possible, irrespective of whether the operator is a right-handed person or a left-handed person, to use the device or the three-way valve in its preferred handling, so that, for example, either the left or the right turntable for further rotation of the first housing part relative to the second housing part can be used.
  • the two slewing rings take up the second housing part encompassing each other, wherein the inner and outer housing walls are at least partially enclosed.
  • the second housing part is captively fixed by the housing part, at the same time by the existing through hole and the cylindrical extension of the first housing part a common rotary motion is made possible without jamming or tilting of the two housing part could occur against each other.
  • the two slewing rings have a plurality of circumferentially distributed and inner recesses, which correspond with locking lugs of the second housing part.
  • Locking lugs is thus ensured at a rotation of the two housing parts that exactly the next rotational position has been reached. Reaching the user of the three-way valve can be clearly felt by the engagement of the locking lug.
  • the latching recesses and latching lugs are designed such that a rotation can take place only in a preferred direction. This ensures that successive individual operations can be performed, for example, aspiration of air and increase the pressure in the reservoir, removal of the liquid and delivery of the liquid to a connected container, such as infusion bags.
  • the two turntables circumferentially distributed on the outside, preferably offset by 90 ° have different markings. With the aid of the markings, the user can thus always check in which position the three-way valve is currently in order to carry out the next work step.
  • the respective offset by 90 ° degrees arranged marks correspond in this case directly with the respective latching steps of the two housing parts.
  • the two slewing rings of the first housing part can in this case be round or polygonal with rounded edges, so that a good grip is ensured and on the ground the present size of the slewing rings a small amount of force sufficient.
  • An unintentional rotation of the two housing parts is hereby prevented on the one hand and on the other hand ensures a smooth running, so that with normal force application, a rotation can take place.
  • the second housing part consists of an inner and outer cylindrical housing wall, wherein the two housing walls are connected to each other via radial braces, which simultaneously accommodate the flow channels.
  • the present embodiment of the second housing part advantageously allows the production by an injection molding process and, moreover, a stable embodiment for the second housing part is achieved with the lowest possible cost of materials.
  • a handle preferably in one piece, is formed. The handle serves to hold the device, during the execution of the individual steps, in particular during rotation of the first housing part relative to the second housing part.
  • the second housing part has a plurality of radially protruding connections, which are arranged in extension of the inner struts and extend the flow channels in the radial direction.
  • the braces thus not only serve to connect the inner and outer casings of the second housing part, but in addition they also fulfill the purpose of liquid transport, since the flow channels are formed in these struts. This measure in turn ensures that a cost-effective design is achieved with the lowest possible cost of materials and simple production methods.
  • the protruding connections consist of so-called Luer connections, which are either provided with a captive union nut or have a Luer thread, so that a nut can be screwed onto the Luer connection.
  • the protective cap for the piercing spike can be fixed to the existing Luer connection with the aid of a union nut.
  • the Luer connections have a thread, it is possible to screw a commercially available syringe or a connecting tube directly to the Luer connection, so that a liquid-tight connection to the device, that is to the three-way valve, can be produced.
  • a bottle adapter is used to connect a storage bottle, which is cup-shaped.
  • the connection adapter in this case has at least two support feet, which come to rest directly on the device supporting. This measure serves to be able to safely catch even larger weights of a possible storage container and, moreover, to avoid damaging the storage container or the device during handling of the device. to prevent the and in particular a cancel the attached storage tank.
  • the bottle adapter is firmly connected in this case with the reservoir, wherein the bottle adapter on the pot-shaped side to the reservoir circumferentially distributed has a plurality of slots.
  • the bottle adapter has an annular, interrupted by the slots collar which lays around the neck of the bottle.
  • a connection is connected to a filter unit which consists of a filter material and a non-return spring acting in one direction.
  • the filter unit is in this case preferably arranged in the hollow-walled handle and allows the suction of air through a connected syringe. The sucked air is in turn added to the reservoir before it comes to the removal of the liquid.
  • the filter unit has next to the filter material a check spring, which works only in one direction.
  • the return spring allows suction of air, but prevents the pressurized air with the help of the syringe, the air can escape through the filter back into the atmosphere.
  • connection of an infusion bag is preferably via a hose connection which can be fixed at one end to the device by means of a Luer connection, while at the other end the hose connection has a connection adapter which protects against injury by an elastic protective cap for a piercing spike used for the transfer of fluid having.
  • the reservoir for the liquid may for example consist of an ampoule or a glass bottle, while the delivery is carried out in a second container, which is preferably designed as an infusion bag.
  • Known infusion bags in this case have two ports, at least one port for receiving a piercing mandrel serves as a connection adapter, while another port can be configured as a pressure relief valve.
  • further adapters may be provided to permit removal of fluids from these reservoirs to be delivered directly to the three-way valve.
  • two or more devices, if necessary, are connected in series with one another via the Luer connections and the respective medicaments are taken out of the storage containers one after the other and transported via the existing flow channels to the infusion bag.
  • the present invention is thus distinguished by its simple design and manageability, it being ensured in any case that after receiving the medicament from a storage container, no liquid is released into the environment and, moreover, no air possibly contaminated with the medicament the environment passes. It is therefore assumed that the system is closed. This is ensured by first using the syringe air sucked through a filter with a check valve and then discharged into the reservoir. This creates an overpressure in the reservoir, which makes it possible to remove with the help of the syringe, after a rotation of the three-way valve is done, from the reservoir in the desired amount. After further rotation of the three-way valve, a connection channel is opened to a further connection, to which, for example, a hose connection of an infusion bag is connected.
  • the drug in the syringe can be delivered via the flow channel and the connecting tube into the infusion bag.
  • this process can be repeated several times with the same drug or it can be taken from different reservoirs drugs and fed to the infusion bag as far as an exchange of the reservoir takes place.
  • multiple three-way valves arranged in series may be used to deliver various medicaments into the infusion bag.
  • FIG. 1 shows a perspective view of the device according to the invention
  • FIG. 2 shows a perspective exploded view of the device according to FIG. 1,
  • FIG. 3 shows a sectional perspective view of the device in the assembled state in a first rotational position
  • FIG. 4 shows a sectional perspective view of the essential elements of the device according to the invention
  • FIG. 6 shows a sectional view of the first housing part according to FIG. 5,
  • FIG. 7 shows, in a further sectional view, the first housing part according to FIG. 5, FIG. 8, in a perspective view, that second part of the first housing part,
  • FIG. 9 shows a perspective view of the second housing part
  • FIG. 10 shows a perspective view of the second housing part with attached luer nuts
  • connection adapter 13 shows a perspective view of a connection adapter for the storage container
  • FIG. 1 shows a perspective view of a filter unit for use with the device according to the invention
  • FIG. 15 is a perspective exploded view of the filter unit according to FIG. 14;
  • FIG. 17 is a protective cap for the piercing spike.
  • FIG. 1 shows a perspective view of the essential components of a device 1 with further components which are provided for connecting a storage container 2 and an infusion bag 18.
  • the device 1 according to the invention is a so-called three-way valve, which allows the flow direction of a liquid from a reservoir 2 first into a syringe 3 and from the syringe 3 via a hose connection 4 and a connection adapter 5 in an infusion bag 18.
  • the device 1 consists of two housing parts, namely a first housing part 6 and a second housing part 7, which are rotatably supported in each other and with the aid of a turntable 8, 9 allow a rotation against each other.
  • the first housing part 6 is in this case received in a second housing part 7 with a handle 10, so that a good handling of the device 1 is made possible.
  • a good handling of the device 1 is made possible.
  • the Luer connector 12 also has a thread to set a protective cap for a lying in the protective piercing mandrel using a union nut 15.
  • the plug-in mandrel is in this case mounted over a snug fit in the Luer connection 12.
  • a bottle adapter 16 can be attached to the device 1 by means of the union nut 15.
  • the bottle adapter 16 has been previously connected to the reservoir 2, so that the reservoir 2 can be captively screwed to the device 1.
  • a Luer connection 13 and a union nut 17 the connection of a connecting tube 4, which at the other end can be connected via the connection adapter 5 to an infusion bag 18, takes place.
  • the connection adapter 5 consists of a base body 28 with diametrically opposed pivotally arranged brackets 19, 20 and a concealed by a protective cap 21 arranged piercing.
  • a Luer connector 22 is present, so that a connection can be made via a union nut 23 with the connecting tube 4.
  • connection 26 of the infusion bag 18 is used to receive an infusion solution, which can be additionally mixed with the drug.
  • connection hose 4 with connection adapter 5 the connection 26 is provided, which offers the possibility of piercing the piercing spike, which is not apparent from this drawing figure, through a rubber membrane in the infusion bag 18.
  • connection 27 it is also possible to connect further adapters, or this connection 27 is equipped with a check valve, so that an overpressure can escape from the infusion bag 18.
  • a filter unit 25 is connected to the device 1 according to the invention, which allows the suction of air through the syringe 3.
  • the sucked air serves to press with the help of the syringe 3, the air in the reservoir 2, so that in the reservoir 2, an overpressure. Only with the overpressure in the reservoir 2 is it possible to remove the drug from the reservoir 2 by means of the syringe 3 by suction. For this purpose, it is necessary to force that the reservoir 2 next to the drug has an air cushion, which can be set by means of the syringe 3 under pressure.
  • the storage bottles 2 can never be completely filled, so that below the filling opening an air cushion will always form, which can be used in connection with the device 1 according to the invention for the removal of the medicament, after an overpressure has been achieved.
  • the peculiarity of the present inventive device 1 is that, as shown in Figure 1, a closed system is formed, which after connection of the reservoir 2 by means of the bottle adapter 16 and after connection of the infusion bag 18 by means of the connecting tube 4 and the connection adapter , As well as the necessary syringe for liquid transport and the device 1 according to the invention a closed system is formed.
  • the filter unit 25 which has a check valve, so that although air sucked into the system, but can not be discharged to the outside.
  • the essential details of the device 1 according to the invention will be explained again in more detail with reference to the figures which follow, in which essentially the first and second housing parts 6, 7 as well as the design of the bottle adapter 16 are shown.
  • the housing parts 6, 7 are shown here in different sectional views in order to explain the mode of operation.
  • FIG. 2 shows in a perspective exploded view the most important components of the device 1 according to the invention.
  • the first housing part 6 which consists of a cylindrical housing wall 30 with a turntable 8, wherein the turntable 8 preferably integrally connected to the cylindrical housing wall is.
  • the first housing part includes a further turntable 9, which can be placed on a hexagonal molding 32 via a hexagon 31, wherein a connection of the two parts of the first housing part 6 can take place with the aid of a clamping mechanism or optionally with the aid of a screw connection.
  • the first housing part 6 is received in the second housing part 7, which consists of an inner housing wall 33 and an outer housing wall 34.
  • the inner housing wall 33 has a through-hole 35, so that the cylindrical housing wall 30 of the first housing part 6 is inserted into the through-hole. 35 can be introduced.
  • Circumferentially distributed are located on the second housing part 7 more Luer connections of which a first Luer connection 12 and a second Luer connection 13 are each shown with a union nut.
  • Another Luer connector is hidden behind the second housing part 7.
  • a handle 10 which is hollow-walled and has the shape of a circular ring segment, integrally formed. Within the handle 10 is a connection piece 36 of the second housing part 7, on which a filter unit 25 can be placed.
  • the filter unit 25 consists of a valve cap 37, a valve disc 38, a valve and filter housing 39, a filter disc 40 and a filter cap 41. With the help of the valve cap 37, the filter unit 25 is attached to the terminal 36 captive and clamped. Via the filter unit 25, it is possible via a connected syringe on the Luer port 13 to absorb air from the environment and then into a reservoir, which is preferably connected via the Luer port 12 to deliver. Following this, the liquid can be sucked out of the storage container with the aid of the syringe and, after rotation of the two housing parts 6, 7 of the device 1, can be delivered to the Luer connection 13 for forwarding to an infusion bag. It is further apparent from FIG.
  • FIG. 3 shows, in a cutaway perspective view, the device 1 known from FIG. 1 without connection hose and connection adapter.
  • the second housing part 7 can be seen in a cut shape and a part of the first housing part 6 with turntable 8 and cylindrical housing 30.
  • the rotational position of the two housing parts 6, 7 to each other here opens a flow channel 50, which is angled in the radial direction and at right angles Flow passage portion 50 a of the cylindrical housing wall 30 and a flow channel portion 50 b and 50 c is formed, wherein the flow channel sections 50 b and 50 c are formed in the radial struts 51, 52 of the second housing part 7.
  • the struts 51, 52 in this case connect the inner housing wall 33 with the outer housing wall 34 of the second housing part 7.
  • On the second housing part 7 of the handle 10 is formed, which can only be seen on one side due to the sectional view.
  • the filter unit 25 which is connected via a connecting piece 36 with the second housing part 7.
  • a connecting piece 36 with the second housing part 7.
  • this is a Press fit selected.
  • a syringe 3 is connected to a piston, while to the terminal 12 via a bottle adapter, a reservoir 2 is connected.
  • a plunger 42 which is held in the port 12 via a press fit, extends into the interior of the reservoir 2.
  • the bottle adapter 16 is in this case screwed via a union nut 15 with the second housing part 7, so that a secure attachment is ensured.
  • the Luer connector 13 with union nut 7 is used to connect a connecting hose 4, which is not shown in this figure.
  • the rotational position of the turntable 8 of the first housing part 6 opens the flow channel 50, so that in a first step with the help of the syringe 3 and the piston 54 air from the atmosphere via the filter unit 25 can be sucked.
  • a subsequent rotation of the turntable 8 then allows a connection of the syringe 3 with the reservoir 2, so that the sucked air can be pressed to generate an overpressure in the reservoir 2. Thereafter, the liquid is sucked from the reservoir 2 and thus enters the syringe 3.
  • FIG. 4 shows, in a cutaway perspective view, the device 1 with syringe 3 and piercing spike 42.
  • the syringe 3 is fastened to the Luer connection 11, namely screwed onto the existing Luer thread, while the piercing spike 42 is press-fitted to the Luer connection 12 is received and a union nut 15 is provided for attachment of the cap or the bottle adapter.
  • the sectional view clearly shows how the first housing part 6 is accommodated in the second housing part 7 and in particular that the first housing part 6 consists of an inner housing wall 30 with integrally formed turntable 8 and a second turntable 9.
  • the second housing part 7 consists of an outer cylindrical wall 34 and an inner cylindrical wall 33.
  • a flow channel 60 is formed, which extends at an angle of 45 degrees flow channel portion 60a in the cylindrical housing wall 30 of the first housing part 6 and a flow channel section 60b and 60c, wherein the flow channel sections 60b and 60c are formed in the struts 52 of the second housing part 7.
  • the representation of the syringe 3 in this illustration corresponds to a position after the air has been discharged into the reservoir, not shown, generating an overpressure.
  • the liquid with the help of the syringe 3 is sucked out of the reservoir and can then be forwarded after rotation of the first housing part 6 relative to the second housing part 7 to a further Luer connection to which a connection tube can be connected to the infusion bag ,
  • Figure 5 shows an enlarged perspective view of a portion of the first housing part 6 with the turntable 8 and the cylindrical housing 30.
  • the turntable 8 is formed in the illustrated embodiment square with rounded corners and has on its outer side circumferentially distributed by 90 degrees offset markings 61 on , On the inside at the level of the markings 61 are recesses 62, which would be provided for receiving a latching lug of the second housing part 7.
  • the formation of this latching recess 62 and the corresponding latching lugs thus allows the first housing part 6 to be rotated only in one direction within the through-bore of the second housing part 7. This ensures that the various steps are performed one after the other in the correct order.
  • the cylindrical housing wall 30 has a flow channel section 60a designed to be at 45 degrees to the radial direction, as well as a flow channel section 50a bent at right angles in the radial direction.
  • the cylindrical housing 30 has a hexagonal end 63, which is insertable in a corresponding recess of the second turntable 9, whereby securing of the two parts of the first housing part 6 ensured by a deadlock or possibly a screw is.
  • FIG. 6 shows a sectioned perspective view of the housing part 6 according to FIG. 5, it being clear from this sectional view that the slewing ring 8 has a hollow wall. leads and the cylindrical housing wall 30 is provided for receiving the flow channel sections 50a and 60a.
  • Figure 7 shows in a perspective sectional view of the known from Figure 5 part of the first housing part 6 in a further sectional view and that in the radial direction through the cylindrical housing 30 at the level of the flow channel portion 50a, from which it is apparent that this is perpendicular to each extending in the radial direction ,
  • FIG. 8 shows in a perspective view the second turntable 9 with a hexagonal recess 64, which is provided for receiving the hexagon of the second housing part with turntable 8.
  • This turntable also has circumferentially distributed markings 65 offset by 90 degrees on the outside, however, no latching recesses are formed in this turntable 9.
  • the two slewing rings 8, 9 are guided in each case via a guide projection 66 or 67 in the cylindrical bore of the second housing part 7 and rotatably mounted, whereby due to a corresponding fit accuracy inadvertent leakage of the liquid in the contact areas of the first and second housing part 6, 7 can be excluded.
  • FIG. 9 shows in a perspective view the second housing part 7 with outer housing wall 34 and inner housing wall 33 and handle 10.
  • the inner housing wall 33 simultaneously forms the through-bore 30, so that the first housing part 6 can be inserted into the second housing part 7 with an exact fit.
  • the luer connections 11, 12, 13, which are provided in part with a Luer thread are distributed over the circumference.
  • circumferentially distributed two locking lugs 70 are integrally connected to the second housing part 7.
  • the locking lugs 70 are formed in a corresponding arrangement to the latching recesses of the first housing part 6, so that, as already stated, the two housing parts 6, 7 can be rotated against each other only in one direction of rotation.
  • FIG. 10 shows the view from FIG. 9 of the second housing part 7 with union nuts 15, 17.
  • FIG. 11 shows the shape of the second housing part 7, which is known from FIG. 9, in a sectional illustration, namely in the radial direction, at the level of the Luer connections 11, 12 and the connection socket 36. From this representation, it can be seen that the Luer connections 11, 12 with a flow passage portion 50b, 50c, which are arranged corresponding to the luer terminals 11, 12, open into the cylindrical through-hole 35. Offset in the axial direction also opens the Luer connector 13 in this through hole 35 so that depending on the respective rotational positions in each case a connection between two Luer connections by means of the first housing part 6 can be produced.
  • the connecting piece 36 has a flow channel portion 71, which also opens into the through hole 35.
  • FIG. 12 shows, in a perspective view, the second housing part 7 in a further sectional view, to be precise in the amount of the Luer connection 13, which in the present case is provided for connecting a connecting tube. Also, the flow passage formed here opens into the through hole 35th
  • FIG. 13 shows the bottle adapter 16, which can be screwed directly to the second housing part 7 via the union nut via a cylindrical connection 80 with Luer thread 81.
  • two radial braces 82 are provided, which come to lie with a rounded top 83 directly on the outer housing wall 34 of the second housing part 7.
  • On the upper side of the bottle adapter 16 has a pot-shaped formation which is interrupted by axialver Anlagende slots 84 so that the individual segments are resiliently pressed outwards when the bottle adapter 16 is placed on the reservoir.
  • the individual elements between the slots 84 have an inwardly projecting collar 85 which engages directly around the bottle neck of the storage container and thus prevents it from slipping off.
  • FIG. 14 shows the filter unit 25 in a perspective view, wherein the individual parts of the filter unit 25 can be seen from the following FIG.
  • FIG. 15 shows, in a perspective exploded view, the filter unit 25 with its individual parts, namely a valve cap 37 with a connection piece 91, which is provided for pressing into the connection piece of the second housing part 7.
  • the valve cap 37 serves to receive a valve disc 38, a valve and filter housing 39, a filter disc 40 and a filter cap 41, wherein the filter cap 37 and the valve and filter housing 39, and the filter cap 41 are pressed together and give a total of the filter unit 25 ,
  • the filter disc 40 allows cleaning of the intake air by means of the syringe, while the valve disc 38 is designed as a check valve and allows air to enter only from below through an opening 92.
  • the valve disc 38 is inserted into a recess 94 of the valve and filter housing 39, wherein a central elevation with a sealing edge 95 is formed.
  • the valve disc 38 itself consists of an annular body 96, with axially extending slots 97, which subdivide the annular body 96 segment-like.
  • a spherical membrane 98 in the Center of the valve disc 38 is a spherical membrane 98, which comes to the sealing edge 95 to the plant. During the suction of the air, the membrane 98 is lifted from the sealing edge 95 and pressed at an overpressure against the sealing edge 95, so that the function of a check valve is met.
  • FIG. 16 shows a side view of the puncturing needle 42 known from FIG.
  • FIG. 17 shows the protective cover 14 known from FIG. 2 for the puncture needle 42, which can be fastened to the second housing part with the aid of a Luer thread 99 and the union nut (not shown).
  • the insertion needle 42 is used directly for removal of
  • the protective cover needs to be removed only once from the puncture needle and after pressing the puncture needle in the reservoir by means of the bottle adapter 16 a firm connection between the reservoir and the second housing part is made via a Luer fitting.
  • the present invention is characterized in that a closed system is formed, wherein with the aid of a syringe 3 via a filter unit 25 first air sucked and cleaned at the same time and is ensured by means of a check seal that upon actuation of the syringe 3 depending on the different Rotary positions of the two housing parts 6, 7 can get no air to each other to the outside. Depending on the rotational position of the two housing parts 6, 7, air can first be sucked from the atmosphere and then released after rotation by 90 degrees to generate an overpressure in the reservoir.
  • liquid can be withdrawn from the storage container with the aid of the syringe 3 and then, after rotation through 90 degrees, the liquid taken in via a further flow channel to a Luer connection, that is to say via an interconnector, for example, to an infusion bag.
  • a Luer connection that is to say via an interconnector, for example, to an infusion bag.
  • the entire assembly is intended for single use, until the reservoir is used up.
  • a double or optionally triple arrangement of this device can be used in a serial arrangement, so that the medication can be taken from different storage containers in succession and delivered via the connection line to the injection bag.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Hematology (AREA)
  • Biomedical Technology (AREA)
  • Anesthesiology (AREA)
  • Pulmonology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

L'invention concerne un dispositif (1) d'application de médicaments fluides, notamment de cytostatiques, comportant un boîtier (6, 7) composé d'au moins deux parties pouvant tourner l'une par rapport à l'autre, présentant plusieurs raccords (11, 12, 13) et au moins un élément de réception de liquide (3). Un médicament peut être prélevé au moins dans un premier réservoir (2) au moyen de l'élément de réception de liquide, et un deuxième réservoir (18) peut être rempli au moyen d'une liaison par flexible (14). Un premier passage peut être relié alternativement à un deuxième passage, et un troisième passage peut être bloqué de manière à éviter une explosion de liquide dans l'environnement. L'invention vise à mettre en oeuvre un dispositif (1) d'application de médicaments fluides obéissant à un standard de sécurité élevé. A cet effet, l'invention prévoit un système fermé composé de deux parties de boîtier (6, 7) pouvant tourner l'une par rapport à l'autre et formant un distributeur à trois voies au moyen de plusieurs canaux de passage, divers accessoires médicaux pouvant être raccordés audit distributeur.
PCT/IB2010/002167 2009-09-04 2010-09-02 Dispositif d'application de médicaments fluides Ceased WO2011027207A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102009040016.8A DE102009040016B4 (de) 2009-09-04 2009-09-04 Vorrichtung zur Applikation von fluidalen Medikamenten
DE102009040016.8 2009-09-04

Publications (1)

Publication Number Publication Date
WO2011027207A1 true WO2011027207A1 (fr) 2011-03-10

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PCT/IB2010/002167 Ceased WO2011027207A1 (fr) 2009-09-04 2010-09-02 Dispositif d'application de médicaments fluides

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WO (1) WO2011027207A1 (fr)

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WO2016166197A1 (fr) 2015-04-17 2016-10-20 Centre Hospitalier Universitaire D'amiens-Picardie Dispositif de bouchage pour permettre un prélèvement d'une composition ensemble de conditionnement comprenant un tel dispositif de bouchage, procédés de prélèvement et de conditionnement
CN111298267A (zh) * 2020-02-24 2020-06-19 上海长海医院 伤口镇痛缓释系统
CN116115898A (zh) * 2023-01-18 2023-05-16 湛江健力源医疗用品有限公司 闭环运转的三通式药液转移器

Families Citing this family (3)

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DE102016123658B4 (de) * 2016-12-07 2021-10-07 Technische Universität Dresden Filtrationsvorrichtung und Verfahren zur Anreicherung von Targets und der nachfolgenden Freisetzung biogener Agenzien
AT519623A1 (de) * 2017-02-08 2018-08-15 Hubertus Goller Ges M B H Mischvorrichtung
DE102023101559A1 (de) * 2023-01-23 2024-07-25 Neoperl Gmbh Fluidische Umlenkeinheit und Verwendung eines Schlauches

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WO1991018632A1 (fr) * 1990-05-25 1991-12-12 St. Jude Medical, Inc. Vanne de commande de fluide
WO2003029706A1 (fr) * 2001-10-02 2003-04-10 George Loo Robinet presentant une ouverture axiale pour seringue actionnee par rotation
US20060089603A1 (en) * 2004-10-22 2006-04-27 Truitt Tim L Fluid control device with valve and methods of use

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DE3503320A1 (de) * 1985-01-31 1986-08-07 Baxter Travenol Laboratories, Inc., Deerfield, Ill. Mehrwegeventil
WO1991018632A1 (fr) * 1990-05-25 1991-12-12 St. Jude Medical, Inc. Vanne de commande de fluide
WO2003029706A1 (fr) * 2001-10-02 2003-04-10 George Loo Robinet presentant une ouverture axiale pour seringue actionnee par rotation
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Publication number Priority date Publication date Assignee Title
WO2016166197A1 (fr) 2015-04-17 2016-10-20 Centre Hospitalier Universitaire D'amiens-Picardie Dispositif de bouchage pour permettre un prélèvement d'une composition ensemble de conditionnement comprenant un tel dispositif de bouchage, procédés de prélèvement et de conditionnement
FR3035080A1 (fr) * 2015-04-17 2016-10-21 Centre Hospitalier Univ D'amiens-Picardie Dispositif de bouchage pour permettre un prelevement d'une composition ensemble de conditionnement comprenant un tel dispositif de bouchage, procedes de prelevement et de conditionnement
CN107750225A (zh) * 2015-04-17 2018-03-02 亚眠-皮卡底高等商学校医疗中心 用于可以收集组合物的密封装置、包括该密封装置的包装组件、收集与包装方法
CN107750225B (zh) * 2015-04-17 2019-10-11 亚眠-皮卡底高等商学校医疗中心 用于可以收集组合物的密封装置、包括该密封装置的包装组件、收集与包装方法
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CN111298267A (zh) * 2020-02-24 2020-06-19 上海长海医院 伤口镇痛缓释系统
CN116115898A (zh) * 2023-01-18 2023-05-16 湛江健力源医疗用品有限公司 闭环运转的三通式药液转移器
CN116115898B (zh) * 2023-01-18 2023-12-15 广东健力源医疗科技有限公司 闭环运转的三通式药液转移器

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