EP4308461A2 - Device for the automatic filling of syringes with injection liquid - Google Patents

Device for the automatic filling of syringes with injection liquid

Info

Publication number
EP4308461A2
EP4308461A2 EP22723488.7A EP22723488A EP4308461A2 EP 4308461 A2 EP4308461 A2 EP 4308461A2 EP 22723488 A EP22723488 A EP 22723488A EP 4308461 A2 EP4308461 A2 EP 4308461A2
Authority
EP
European Patent Office
Prior art keywords
syringe
vial
plunger
injection
injection needle
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.)
Pending
Application number
EP22723488.7A
Other languages
German (de)
French (fr)
Inventor
Wilhelmus Godefridus Arnoldus Maria Weijers
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.)
W Weijers' Holding BV
Original Assignee
W Weijers' Holding BV
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from NL2027758A external-priority patent/NL2027758B1/en
Application filed by W Weijers' Holding BV filed Critical W Weijers' Holding BV
Publication of EP4308461A2 publication Critical patent/EP4308461A2/en
Pending legal-status Critical Current

Links

Classifications

    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65BMACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B3/00Packaging plastic material, semiliquids, liquids or mixed solids and liquids, in individual containers or receptacles, e.g. bags, sacks, boxes, cartons, cans, or jars
    • B65B3/003Filling medical containers such as ampoules, vials, syringes or the like
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65BMACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B3/00Packaging plastic material, semiliquids, liquids or mixed solids and liquids, in individual containers or receptacles, e.g. bags, sacks, boxes, cartons, cans, or jars
    • B65B3/04Methods of, or means for, filling the material into the containers or receptacles
    • B65B3/10Methods of, or means for, filling the material into the containers or receptacles by application of pressure to material
    • B65B3/12Methods of, or means for, filling the material into the containers or receptacles by application of pressure to material mechanically, e.g. by pistons or pumps
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65BMACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B43/00Forming, feeding, opening or setting-up containers or receptacles in association with packaging
    • B65B43/42Feeding or positioning bags, boxes, or cartons in the distended, opened, or set-up state; Feeding preformed rigid containers, e.g. tins, capsules, glass tubes, glasses, to the packaging position; Locating containers or receptacles at the filling position; Supporting containers or receptacles during the filling operation
    • B65B43/54Means for supporting containers or receptacles during the filling operation
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65BMACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B57/00Automatic control, checking, warning, or safety devices
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65BMACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B59/00Arrangements to enable machines to handle articles of different sizes, to produce packages of different sizes, to vary the contents of packages, to handle different types of packaging material, or to give access for cleaning or maintenance purposes
    • B65B59/04Machines constructed with readily-detachable units or assemblies, e.g. to facilitate maintenance
    • 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
    • A61M5/008Racks for supporting syringes or needles
    • 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

Definitions

  • the invention relates to a device for automatically filling syringes with injection liquid, comprising: - a syringe holder for several syringes provided with injection needles, a vial holder for a vial with injection liquid, displacement means for displacing the vial holder and the syringe holder relative to each other in order to successively get each of the injection needles into the injection liquid contained in the vial, and - pull-out means for moving a plunger of a syringe in a cylindrical housing of the syringe in order to get the injection liquid from the vial into the respective syringe.
  • Such a device is known from US 2008/6169045 A.
  • a vial is successively pressed onto injection needles of syringes in a carousel and subsequently the plunger of the syringe is pulled out, whereby injection liquid is drawn from the vial into the housing of the syringe.
  • the carousel is part of the device and the syringes must be placed in the carousel before filling and removed from the carousel again after filling.
  • the device according to the invention is characterized in that it further comprises: input means for inputting data concerning the vial to be used, syringe and injection needle, a processor for controlling the displacing means and the pull-out means, and a data storage unit which is connected to the processor for data exchange and which contains data for each type of vial relating to the actuation of the displacement means and the pull-out means.
  • 'type of vial' is meant a vial with a specific injection liquid, with a different injection liquid being present in the vial for each type of vial.
  • the vials of one species have the same injectable liquid in them and thus vials of different species have different injectable liquids in them.
  • the filling of the syringes can be automated so that errors caused by human actions are virtually excluded. The chance that syringes are not supplied with the correct amount of liquid is therefore very small.
  • the processor is further configured to store syringe filling data in the data storage unit for later use for monitoring and analysis.
  • This data includes, for example, the number of filled syringes and/or the processed amount of injection fluid and/or data about the scanned labels on the vials.
  • the device is preferably provided with data exchange means, for instance a physical data port or transceiver, in order to be able to update the data present in the data storage unit (data input).
  • data exchange means for instance a physical data port or transceiver
  • This is advantageous, for example, in case a new injection liquid comes on the market, whereby the syringes have to be filled with a specific amount of this injection liquid.
  • the device can then automatically be provided with the data required for this.
  • the syringe holder is removably in the device and is provided with an identifier and the device comprises recognition means which can read the identifier and can store it in the data storage unit and link it to the entered data of the vial, syringe and injection needle used. This makes it possible to trace the origin of a used syringe and the syringe holder and the injection liquid contained therein.
  • the vial holder is preferably configured to accommodate vials of different sizes.
  • a further embodiment of the device according to the invention is characterized in that: the syringe holder is fixed in the device during use, the displacing means and the pull-out means are present on a carriage, and the device further comprises carriage means for moving the carriage along the syringe holder and successively positioning the carriage relative to each syringe present in the syringe holder.
  • the syringe holder is removable and can be of compact and simple construction, several syringe holders can be used with one device, whereby they are pre-equipped with empty syringes and after filling they can be transported together with the filled syringes to the vaccination or inoculation location without having to remove the syringes from the syringe holder first.
  • a carriage on which the displacing means and the pull-out means are present can also be used advantageously in a device without input means and a data storage unit for data and without a processor for controlling the displacing means and the pull-out means.
  • An embodiment of the device according to the invention is characterized in that in the device two syringe holders can be fixed parallel to one another and at a distance from each other and the carriage can be moved between the two syringe holders and for each of the syringe holders is provided with displacing means and pull out means.
  • the displacing means are preferably displaceable simultaneously and also the pull-out means are displaceable simultaneously.
  • the vial holder is preferably configured to hold a vial at an angle to the vertical direction.
  • the opening in the vial is closed liquid-tight by a membrane through which an injection needle can be inserted, whereby the membrane closes liquid-tight again after the injection needle has been withdrawn.
  • the syringe holder is preferably formed by the syringe holder formed by a form-retaining, straight, elongate tray with several clamping elements for syringes arranged side by side in the longitudinal direction.
  • a further embodiment of the device according to the invention is characterized in that during use in a horizontal direction, the clamping elements (21) are offset from each other perpendicular to the longitudinal direction of the tray (31) so that the clamping elements (21) are not in a straight line.
  • the injection needles staggered relative to each other ensure that each time the injection needles pierce the membrane at a different location. This staggering of the puncture location can also be realized by means of electronic control.
  • the carriage means are preferably configured to move the carriage in the longitudinal direction of the syringe holder in each case over a distance that is slightly different from the distance between adjacent syringes, wherein these distances differ slightly from each other, so that the membrane present in the vial is pierced each time at a different location.
  • the pull-out means are preferably configured such that when filling a syringe the plunger first pulls out too much so that too much injection liquid is drawn into the syringe and then pushes the plunger back until the desired amount of injection liquid remains in the syringe.
  • the invention also relates to a method for mechanically filling a syringe provided with an injection needle with injection liquid present in a vial, which vial is provided with an opening which is closed by a pierceable and self-sealing layer, and which syringe is provided with a housing and a plunger present therein and being movable between a maximally depressed position and a maximally pulled out position, which housing has a cylindrical part in which the plunger is movable, and a neck part connected to the cylindrical part and having a smaller cross-section than the cylindrical part and an injection needle that is connected to the neck part.
  • the invention is characterized in that it comprises the following steps, with the layer of the vial facing down: with the plunger in the maximum depressed position, insert the injection needle through the layer or pressing the vial over the injection needle until the open end of the injection needle is in the injection fluid by moving the syringe and the vial relative to each other by mechanical displacement means, pulling out the plunger over a first distance, wherein the air present above the plunger and in the injection needle can form an air bubble on the plunger and the remaining space above the plunger and in the injection needle is filled with injection liquid by moving the plunger and the housing relative to each other by the mechanical displacement means, pulling the syringe from the vial or pulling the vial from the injection needle until the open end of the injection needle is out of the injection fluid by displacing the syringe and the vial relative to each other by means of mechanical displacement means, pulling the plunger further over a second distance at a second speed greater than the first speed, wherein, in case an air bubble is formed on the
  • a syringe By filling a vial in this way, a syringe can be filled with exactly the desired amount of injection liquid, while it is ensured that there is no air in the syringe.
  • This method also prevents a negative pressure from being created in the vial, which could be negative for the accuracy of the method, because the air drawn in from the vial into the syringe during the method is also injected back into the vial.
  • the displacement of the syringe and the vial relative to each other preferably takes place here with the aid of mechanical displacing means by holding the syringe stationary and moving the vial.
  • the displacement of the plunger and the housing relative to each other also preferably takes place with the aid of the mechanical displacing means by holding the housing stationary and moving the plunger.
  • Figure 1 a perspective view of an embodiment of the device
  • Figure 2 one of the syringe holders of the device
  • Figure 3 a detail of the device during filling of a first syringe
  • Figure 4 a detail of the device before a fourth syringe is to be filled;
  • Figure 5 a first step during filling a syringe with injection liquid;
  • Figure 6 a detail of the step shown in Figure 5 to clarify the position of the injection needle and the plunger;
  • Figure 7 a second step during the filling of a syringe with injection liquid
  • Figure 8 a detail of the step shown in Figure 7 to clarify the position of the injection needle and plunger;
  • Figure 9 a third step during the filling of a syringe with injection liquid;
  • Figure 10 a detail of the step shown in Figure 9 to clarify the position of the injection needle and plunger;
  • Figure 11 a fourth step during the filling of a syringe with injection liquid
  • Figure 12 a detail of the step shown in Figure 11 to clarify the position of the injection needle and plunger;
  • Figure 13 a fifth and sixth step during the filling of a syringe with injection liquid
  • Figure 14 a detail of the steps shown in Figure 13 to clarify the position of the injection needle and plunger;
  • Figure 15 a seventh step during the filling of a syringe with injection liquid
  • Figure 16 a detail of the step shown in Figure 15 to clarify the position of the injection needle and plunger;
  • Figure 17 an eighth and ninth step during the filling of a syringe with injection liquid
  • Figure 18 a detail of the syringe as it is filled after the ninth step
  • Figure 19 a tenth step during the filling of a syringe with injection liquid
  • Figure 20 a detail of the syringe as it is filled after the tenth step
  • Figure 21 an eleventh and final step during the filling of a syringe with injection liquid
  • Figure 22 a detail of the syringe as it is finally filled.
  • FIG. 1 is a perspective view of an embodiment of the device according to the invention.
  • the device 1 has a housing 3, of which one of side walls 5 has been pushed upwards so that the interior is accessible.
  • Located on the housing is a display screen 7 (touch screen) and a label scanner 9 with which the label of a vial can be read so that the device can obtain the correct setting from pre-entered data.
  • the housing also contains two mounting strips 15 against which syringe holders 17 can be secured with screws 19.
  • the syringe holders 17 are provided with clamping elements 21 between which syringes 23 are clamped.
  • the carriage 13 is movable between the syringe holders 17 located at a distance from each other.
  • a vial holder 25 On each side of the carriage 13 facing the syringe holders 17 is a vial holder 25 with a vial 27 placed therein.
  • the vial holder 25 is configured to receive vials 27 of different sizes and to position the vial 27 at an angle to the vertical direction.
  • This vial holder 25 can be moved in vertical direction by displacing means.
  • a plunger displacing arm 29 which is also movable in vertical direction and which is part of pull-out means.
  • the displacing means move the vial holders 25 on either side of the carriage 13 simultaneously up and down.
  • the plunger displacing arms 29 on either side of the carriage 13 are moved up and down simultaneously by the pull-out means.
  • the device 1 is further provided with input means for inputting data concerning the vial, syringe and injection needle to be used.
  • these input means are designed as a scanner which can, among other things, read the label on the vial.
  • the device is further provided with a processor 8 for controlling the displacement means and the pull-out means, and a data storage unit coupled thereto in the form of a memory chip 10 for exchanging data.
  • This memory chip 10 contains data for each type of vial relating to the actuation of the displacement means and the pull-out means.
  • the processor 8 is connected to data exchange means, which in this embodiment are designed as a USB port 12.
  • the data in the memory chip 10 can be supplemented or updated via this USB port.
  • Data concerning the used syringe holders 17 can also be read out via the USB port in the memory chip 10. Furthermore, the processor 8 stores data in the memory chip 10 regarding the filling of syringes with injection liquid for later use for monitoring and analysis. This data can also be read again via the USB port.
  • FIG 2 the syringe holder 17 with syringes 23 therein is shown separately.
  • the syringe holder 17 is formed by a form-retaining, straight, elongate tray 31 with several clamping elements 21 located next to each other in the longitudinal direction, between which the syringes 23 are clamped.
  • Each syringe 23 preferably has a cylindrical housing 33 with a plunger 35 movable therein.
  • the housing 33 is provided with an injection opening onto which an injection needle 37 is screwed.
  • the clamping elements 21 are shifted relative to each other in horizontal direction perpendicular to the longitudinal direction of the tray 31 (not discernible in the figure), so that the clamping elements 21 are not present in a straight line.
  • the syringe holder 17 is removably in the device 1 and is provided with an identifier 18.
  • the device 1 is provided with recognition means 20 (see figure 1) which can read the identifier 18 and can store it in the data storage unit 10 and link it to the data entered for the vial used.
  • Figure 3 shows a detail of the device during the filling of a first syringe and Figure 4 shows a detail of the device before a fourth syringe is filled.
  • the carriage means are configured to make it possible to subsequently move the carriage 13 in the longitudinal direction of the syringe holder 17 over a distance that differs slightly from the distance between adjacent syringes 23, these distances differing slightly from each other.
  • the pull-out means are configured to first pull out the plunger too much when filling a syringe 23 so that too much injection liquid is drawn into the syringe 23 and then push the plunger 35 back until the desired amount of injection liquid remains in the syringe 23 .
  • Figures 5 to 22 show different steps during the filling of a syringe 23 with injection liquid 39 from a vial 27.
  • This vial 27 is provided with an opening which is closed by a pierceable and self-sealing layer 43.
  • the syringe 23 is comprising a housing 45 and a plunger 35 present therein, which is displaceable between a maximally depressed position and a maximally pulled out position.
  • the vial 27 is in a position with the layer 43 facing downwards.
  • step 1 see figures 5 and 6, the vial 27 is pressed onto the injection needle 37 of the syringe 23 with mechanical displacement means until the open end 38 of the injection needle enters the injection liquid 39.
  • the syringe 23 is held and the plunger 35 is in the maximally depressed position.
  • the mechanical displacing means hereby displace the vial holder 25 in a slot present in the carriage 13.
  • step 2 see figures 7 and 8, the plunger 35 is pulled out over a first distance with further mechanical displacement means.
  • the piston 35 is in this step pulled downwards over a small distance at normal acceleration speed. This distance depends on the injection fluid, the syringe and the injection needle.
  • the surface tension between air and the material of the piston creates an air inclusion 47 that adheres to the piston 35 (this is the amount of air that was above the piston and in the injection needle) with a predetermined column of sucked injection liquid 39 above it.
  • This column of injection liquid runs up to the open tip 38 of the injection needle 37 and is in direct communication with the injection liquid in the vial 27.
  • the further mechanical displacing means hereby displace the plunger displacing arms 29 which hold the end of plunger protruding from the housing.
  • step 3 see figures 9 and 10 the vial 27 is moved away from the syringe 23 by the mechanical displacement means, until the open end 38 of the injection needle 37 is out of the injection fluid 39.
  • step 4 the plunger 35 with the further mechanical displacing means is further pulled out over a second distance.
  • the plunger 35 is pulled down a certain length (this length depends on the amount of air to be blown back (step 5) into the vial to prevent/minimize underpressure when accelerating) at a rapid pull-up speed (the speed depends on the injection fluid, the syringe and the injection needle).
  • the trapped air bubble 47 attached to the piston 35 will hereby be pulled down vertically, making it longer and narrower and therefore less adherent to the piston 35.
  • Injection liquid 39 will also flow around the vertical air bubble in the direction of the piston 35.
  • step 5 the vial 27 is pressed onto the injection needle 37 of the syringe 23 by the mechanical displacement means until the open end 38 of the injection needle is in the injection liquid 39 in the vial 27.
  • step 6 the piston 35 is pushed upwards at a low speed, until it is sufficiently at the top to ensure that the air 41 above the liquid 39 has been completely pressed out in the vial 27 with injection liquid 39, see figure 14.
  • the amount of air blown into the vial 27 has now adjusted the air pressure in the vial so that no disadvantage of underpressure in the vial 27 is experienced when the piston 35 is pulled out.
  • Injection liquid 39 is now located above the piston 35, up to the tip 38 of the injection needle 37.
  • the air pressure in the vial 27 is regulated.
  • step 7 see figures 15 and 16 the plunger 35 is pulled downwards by the further mechanical displacing means until slightly more than the ultimately desired amount of injection liquid 39 has been drawn into the syringe 23 .
  • this air bubble 49 that can be present, is removed from the syringe 23.
  • step 8 the vial 27 is pulled from the syringe 23 by the mechanical displacement means until the tip 38 of the injection needle 37 is out of the vial 27 and is in the air.
  • the vial 27 may be pushed further down over the injection needle 37 until the tip 38 of the injection needle 37 is in the air in the vial 27.
  • step 9 air 41 is drawn into the syringe 23 by further pulling out the plunger 35 by the further mechanical displacing means.
  • the plunger 35 is pulled out that much that air 41 is sucked into the cylindrical part 51 of the housing 45 of the syringe 23 so that the air bubble 49 merges with the sucked air, see figure 18.
  • step 10 of the method see figures 19 and 20, the vial 27 is pressed onto the injection needle 37 by the mechanical displacement means until the tip 38 of the injection needle 37 enters the injection liquid 39 in the vial 27.
  • step 11 see figures 21 and 22, of the method the plunger 35 is pushed further into the housing 45 by the further mechanical displacement means, until the desired amount of injection liquid 39 remains in the syringe 23.

Landscapes

  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Automatic Analysis And Handling Materials Therefor (AREA)

Abstract

A device 1 has a syringe holder 17 for several syringes 23 provided with injection needles 37, a vial holder 25 for a vial 27 with injection liquid, and displacement means for moving the vial holder 25 and the syringe holder 17 relative to each other to successively move each of the injection needles 37 into the injection fluid contained in the vial 27. Furthermore, pull-out means are present for moving a plunger 35 of a syringe 23 in order to get the injection liquid from the vial 27 into the respective syringe 23. The device 1 furthermore has input means 9 for inputting data concerning the vial 27 to be used, a processor 8 for controlling the displacement means and the pull-out means, and a data storage unit 10 which is connected to the processor 8 for data exchange and for containing data of each type of vial 27 relating to the actuation of the displacing means and the pull-out means.

Description

Device for the automatic filling of syringes with injection liquid
DESCRIPTION:
Technical field of the invention
The invention relates to a device for automatically filling syringes with injection liquid, comprising: - a syringe holder for several syringes provided with injection needles, a vial holder for a vial with injection liquid, displacement means for displacing the vial holder and the syringe holder relative to each other in order to successively get each of the injection needles into the injection liquid contained in the vial, and - pull-out means for moving a plunger of a syringe in a cylindrical housing of the syringe in order to get the injection liquid from the vial into the respective syringe.
Background of the invention
Such a device is known from US 2008/6169045 A. In this known device a vial is successively pressed onto injection needles of syringes in a carousel and subsequently the plunger of the syringe is pulled out, whereby injection liquid is drawn from the vial into the housing of the syringe. The carousel is part of the device and the syringes must be placed in the carousel before filling and removed from the carousel again after filling.
Summary of the invention It is an object of the invention to provide a device for filling syringes of the type described in the preamble, in which different vials with different injection liquids can be used and the syringes can be provided with the correct amounts of the injection liquids, while the risk of errors are completely or almost completely excluded. To this end, the device according to the invention is characterized in that it further comprises: input means for inputting data concerning the vial to be used, syringe and injection needle, a processor for controlling the displacing means and the pull-out means, and a data storage unit which is connected to the processor for data exchange and which contains data for each type of vial relating to the actuation of the displacement means and the pull-out means.
By 'type of vial' is meant a vial with a specific injection liquid, with a different injection liquid being present in the vial for each type of vial. Thus, the vials of one species have the same injectable liquid in them and thus vials of different species have different injectable liquids in them.
By providing the device with vial- specific data for filling syringes and means for recognizing the used vial, the filling of the syringes can be automated so that errors caused by human actions are virtually excluded. The chance that syringes are not supplied with the correct amount of liquid is therefore very small.
Preferably, the processor is further configured to store syringe filling data in the data storage unit for later use for monitoring and analysis. This data includes, for example, the number of filled syringes and/or the processed amount of injection fluid and/or data about the scanned labels on the vials.
The device is preferably provided with data exchange means, for instance a physical data port or transceiver, in order to be able to update the data present in the data storage unit (data input). This is advantageous, for example, in case a new injection liquid comes on the market, whereby the syringes have to be filled with a specific amount of this injection liquid. The device can then automatically be provided with the data required for this.
Furthermore, preferably, the syringe holder is removably in the device and is provided with an identifier and the device comprises recognition means which can read the identifier and can store it in the data storage unit and link it to the entered data of the vial, syringe and injection needle used. This makes it possible to trace the origin of a used syringe and the syringe holder and the injection liquid contained therein.
Because vials containing different injection fluids often differ in size, the vial holder is preferably configured to accommodate vials of different sizes. In order to ensure that the device is compact and relatively simple and therefore widely applicable, a further embodiment of the device according to the invention is characterized in that: the syringe holder is fixed in the device during use, the displacing means and the pull-out means are present on a carriage, and the device further comprises carriage means for moving the carriage along the syringe holder and successively positioning the carriage relative to each syringe present in the syringe holder.
Because the syringe holder is removable and can be of compact and simple construction, several syringe holders can be used with one device, whereby they are pre-equipped with empty syringes and after filling they can be transported together with the filled syringes to the vaccination or inoculation location without having to remove the syringes from the syringe holder first.
It is noted that a carriage on which the displacing means and the pull-out means are present can also be used advantageously in a device without input means and a data storage unit for data and without a processor for controlling the displacing means and the pull-out means.
An embodiment of the device according to the invention is characterized in that in the device two syringe holders can be fixed parallel to one another and at a distance from each other and the carriage can be moved between the two syringe holders and for each of the syringe holders is provided with displacing means and pull out means. This means that a double filling capacity can be realized with hardly more space. In order to keep the device simple, the displacing means are preferably displaceable simultaneously and also the pull-out means are displaceable simultaneously.
In order to obtain all of the injection fluid from the vial, the vial holder is preferably configured to hold a vial at an angle to the vertical direction. The opening in the vial is closed liquid-tight by a membrane through which an injection needle can be inserted, whereby the membrane closes liquid-tight again after the injection needle has been withdrawn. By inserting the injection needle of the syringe at the lowest point through the membrane of the vial so that the tip just protrudes through the membrane, all the injection liquid can be withdrawn from the vial. The syringe holder is preferably formed by the syringe holder formed by a form-retaining, straight, elongate tray with several clamping elements for syringes arranged side by side in the longitudinal direction.
In order to ensure that the membrane of a vial is not pierced by an injection needle each time at the same location, a further embodiment of the device according to the invention is characterized in that during use in a horizontal direction, the clamping elements (21) are offset from each other perpendicular to the longitudinal direction of the tray (31) so that the clamping elements (21) are not in a straight line. The injection needles staggered relative to each other ensure that each time the injection needles pierce the membrane at a different location. This staggering of the puncture location can also be realized by means of electronic control.
In order to further separate the locations where the injection needles are pierced through the membrane, the carriage means are preferably configured to move the carriage in the longitudinal direction of the syringe holder in each case over a distance that is slightly different from the distance between adjacent syringes, wherein these distances differ slightly from each other, so that the membrane present in the vial is pierced each time at a different location.
The pull-out means are preferably configured such that when filling a syringe the plunger first pulls out too much so that too much injection liquid is drawn into the syringe and then pushes the plunger back until the desired amount of injection liquid remains in the syringe.
The invention also relates to a method for mechanically filling a syringe provided with an injection needle with injection liquid present in a vial, which vial is provided with an opening which is closed by a pierceable and self-sealing layer, and which syringe is provided with a housing and a plunger present therein and being movable between a maximally depressed position and a maximally pulled out position, which housing has a cylindrical part in which the plunger is movable, and a neck part connected to the cylindrical part and having a smaller cross-section than the cylindrical part and an injection needle that is connected to the neck part.
As far as the method is concerned, the invention is characterized in that it comprises the following steps, with the layer of the vial facing down: with the plunger in the maximum depressed position, insert the injection needle through the layer or pressing the vial over the injection needle until the open end of the injection needle is in the injection fluid by moving the syringe and the vial relative to each other by mechanical displacement means, pulling out the plunger over a first distance, wherein the air present above the plunger and in the injection needle can form an air bubble on the plunger and the remaining space above the plunger and in the injection needle is filled with injection liquid by moving the plunger and the housing relative to each other by the mechanical displacement means, pulling the syringe from the vial or pulling the vial from the injection needle until the open end of the injection needle is out of the injection fluid by displacing the syringe and the vial relative to each other by means of mechanical displacement means, pulling the plunger further over a second distance at a second speed greater than the first speed, wherein, in case an air bubble is formed on the plunger, the air bubble becomes detached from the plunger and in the injection needle and directly below the injection needle merges with the aspirated air by displacing the plunger and the housing by the mechanical displacement means relative to each other, inserting the injection needle into the vial or pushing the vial over the injection needle until the open end of the injection needle is in the injection fluid by displacing the syringe and the vial relative to each other by mechanical displacement means, before or after introducing the open end of the injection needle into the injection fluid depressing the plunger until all air is out of the syringe by displacing the plunger and the housing relative to each other by the mechanical displacement means, pulling the plunger downwards until more than the desired amount of injection liquid is present in the syringe by moving the plunger and the housing relative to each other with the aid of the mechanical displacement means; move, moving the vial and the syringe relative to each other by the mechanical displacement means until the tip of the injection needle is above the injection liquid in the vial or outside the vial in the air, moving the plunger and the housing relative to each other by the further mechanical displacement means, wherein the plunger gets further out of the housing over a distance sufficient to suck the sucked air into the cylindrical part of the housing, moving the vial and the syringe relative to each other by the mechanical displacement means until the tip of the injection needle gets in the injection liquid in the vial, and moving the plunger and the housing relative to each other by the further mechanical displacement means, wherein the plunger moves further into the housing until the desired amount of injection liquid remains in the syringe.
By filling a vial in this way, a syringe can be filled with exactly the desired amount of injection liquid, while it is ensured that there is no air in the syringe. This method also prevents a negative pressure from being created in the vial, which could be negative for the accuracy of the method, because the air drawn in from the vial into the syringe during the method is also injected back into the vial.
The displacement of the syringe and the vial relative to each other preferably takes place here with the aid of mechanical displacing means by holding the syringe stationary and moving the vial.
The displacement of the plunger and the housing relative to each other also preferably takes place with the aid of the mechanical displacing means by holding the housing stationary and moving the plunger.
Brief description of the drawings
The invention will be further elucidated below on the basis of an exemplary embodiment of the device for filling syringes according to the invention shown in the drawings. Hereby is:
Figure 1 a perspective view of an embodiment of the device;
Figure 2 one of the syringe holders of the device;
Figure 3 a detail of the device during filling of a first syringe;
Figure 4 a detail of the device before a fourth syringe is to be filled; Figure 5 a first step during filling a syringe with injection liquid;
Figure 6 a detail of the step shown in Figure 5 to clarify the position of the injection needle and the plunger;
Figure 7 a second step during the filling of a syringe with injection liquid;
Figure 8 a detail of the step shown in Figure 7 to clarify the position of the injection needle and plunger; Figure 9 a third step during the filling of a syringe with injection liquid; Figure 10 a detail of the step shown in Figure 9 to clarify the position of the injection needle and plunger;
Figure 11 a fourth step during the filling of a syringe with injection liquid;
Figure 12 a detail of the step shown in Figure 11 to clarify the position of the injection needle and plunger;
Figure 13 a fifth and sixth step during the filling of a syringe with injection liquid;
Figure 14 a detail of the steps shown in Figure 13 to clarify the position of the injection needle and plunger;
Figure 15 a seventh step during the filling of a syringe with injection liquid;
Figure 16 a detail of the step shown in Figure 15 to clarify the position of the injection needle and plunger;
Figure 17 an eighth and ninth step during the filling of a syringe with injection liquid;
Figure 18 a detail of the syringe as it is filled after the ninth step;
Figure 19 a tenth step during the filling of a syringe with injection liquid;
Figure 20 a detail of the syringe as it is filled after the tenth step;
Figure 21 an eleventh and final step during the filling of a syringe with injection liquid; and
Figure 22 a detail of the syringe as it is finally filled.
Detailed description of the drawings
Figure 1 is a perspective view of an embodiment of the device according to the invention. The device 1 has a housing 3, of which one of side walls 5 has been pushed upwards so that the interior is accessible. Located on the housing is a display screen 7 (touch screen) and a label scanner 9 with which the label of a vial can be read so that the device can obtain the correct setting from pre-entered data. In the housing is a guide 11 on which a carriage 13 is located. This carriage is displaceable over the guide by carriage means. The housing also contains two mounting strips 15 against which syringe holders 17 can be secured with screws 19. The syringe holders 17 are provided with clamping elements 21 between which syringes 23 are clamped. The carriage 13 is movable between the syringe holders 17 located at a distance from each other. On each side of the carriage 13 facing the syringe holders 17 is a vial holder 25 with a vial 27 placed therein. The vial holder 25 is configured to receive vials 27 of different sizes and to position the vial 27 at an angle to the vertical direction. This vial holder 25 can be moved in vertical direction by displacing means. Furthermore, on each of the said sides at the bottom of the carriage 13 there is a plunger displacing arm 29 which is also movable in vertical direction and which is part of pull-out means. The displacing means move the vial holders 25 on either side of the carriage 13 simultaneously up and down. Also, the plunger displacing arms 29 on either side of the carriage 13 are moved up and down simultaneously by the pull-out means.
The device 1 is further provided with input means for inputting data concerning the vial, syringe and injection needle to be used. In this embodiment, these input means are designed as a scanner which can, among other things, read the label on the vial. The device is further provided with a processor 8 for controlling the displacement means and the pull-out means, and a data storage unit coupled thereto in the form of a memory chip 10 for exchanging data. This memory chip 10 contains data for each type of vial relating to the actuation of the displacement means and the pull-out means. In order to keep the data in the memory chip 10 up to date, the processor 8 is connected to data exchange means, which in this embodiment are designed as a USB port 12. The data in the memory chip 10 can be supplemented or updated via this USB port. Data concerning the used syringe holders 17 can also be read out via the USB port in the memory chip 10. Furthermore, the processor 8 stores data in the memory chip 10 regarding the filling of syringes with injection liquid for later use for monitoring and analysis. This data can also be read again via the USB port.
In figure 2 the syringe holder 17 with syringes 23 therein is shown separately. The syringe holder 17 is formed by a form-retaining, straight, elongate tray 31 with several clamping elements 21 located next to each other in the longitudinal direction, between which the syringes 23 are clamped. Each syringe 23 preferably has a cylindrical housing 33 with a plunger 35 movable therein. The housing 33 is provided with an injection opening onto which an injection needle 37 is screwed. The clamping elements 21 are shifted relative to each other in horizontal direction perpendicular to the longitudinal direction of the tray 31 (not discernible in the figure), so that the clamping elements 21 are not present in a straight line.
The syringe holder 17 is removably in the device 1 and is provided with an identifier 18. The device 1 is provided with recognition means 20 (see figure 1) which can read the identifier 18 and can store it in the data storage unit 10 and link it to the data entered for the vial used.
Figure 3 shows a detail of the device during the filling of a first syringe and Figure 4 shows a detail of the device before a fourth syringe is filled.
The carriage means are configured to make it possible to subsequently move the carriage 13 in the longitudinal direction of the syringe holder 17 over a distance that differs slightly from the distance between adjacent syringes 23, these distances differing slightly from each other. The pull-out means are configured to first pull out the plunger too much when filling a syringe 23 so that too much injection liquid is drawn into the syringe 23 and then push the plunger 35 back until the desired amount of injection liquid remains in the syringe 23 .
Figures 5 to 22 show different steps during the filling of a syringe 23 with injection liquid 39 from a vial 27. This vial 27 is provided with an opening which is closed by a pierceable and self-sealing layer 43. The syringe 23 is comprising a housing 45 and a plunger 35 present therein, which is displaceable between a maximally depressed position and a maximally pulled out position. During the filling of the syringe 23, the vial 27 is in a position with the layer 43 facing downwards.
In step 1, see figures 5 and 6, the vial 27 is pressed onto the injection needle 37 of the syringe 23 with mechanical displacement means until the open end 38 of the injection needle enters the injection liquid 39. In this case, the syringe 23 is held and the plunger 35 is in the maximally depressed position. The mechanical displacing means hereby displace the vial holder 25 in a slot present in the carriage 13.
In step 2, see figures 7 and 8, the plunger 35 is pulled out over a first distance with further mechanical displacement means. The piston 35 is in this step pulled downwards over a small distance at normal acceleration speed. This distance depends on the injection fluid, the syringe and the injection needle. As a result, in the worst case, the surface tension between air and the material of the piston creates an air inclusion 47 that adheres to the piston 35 (this is the amount of air that was above the piston and in the injection needle) with a predetermined column of sucked injection liquid 39 above it. This column of injection liquid runs up to the open tip 38 of the injection needle 37 and is in direct communication with the injection liquid in the vial 27. The further mechanical displacing means hereby displace the plunger displacing arms 29 which hold the end of plunger protruding from the housing.
In step 3, see figures 9 and 10, the vial 27 is moved away from the syringe 23 by the mechanical displacement means, until the open end 38 of the injection needle 37 is out of the injection fluid 39.
In step 4, see figures 11 and 12, the plunger 35 with the further mechanical displacing means is further pulled out over a second distance. The plunger 35 is pulled down a certain length (this length depends on the amount of air to be blown back (step 5) into the vial to prevent/minimize underpressure when accelerating) at a rapid pull-up speed (the speed depends on the injection fluid, the syringe and the injection needle). The trapped air bubble 47 attached to the piston 35 will hereby be pulled down vertically, making it longer and narrower and therefore less adherent to the piston 35. Injection liquid 39 will also flow around the vertical air bubble in the direction of the piston 35. Subsequently the vertical air bubble 47 is pulled up through the column of injection liquid 39, as a result of which the entire injection liquid 39 has now flowed onto the piston 35 and the enclosed air has joined the additional air 41 drawn in. The air 41 is thus now above the injection liquid 39 up to the open tip 38 of the injection needle.
In step 5, see figures 13 and 14, the vial 27 is pressed onto the injection needle 37 of the syringe 23 by the mechanical displacement means until the open end 38 of the injection needle is in the injection liquid 39 in the vial 27. Subsequently, in step 6, the piston 35 is pushed upwards at a low speed, until it is sufficiently at the top to ensure that the air 41 above the liquid 39 has been completely pressed out in the vial 27 with injection liquid 39, see figure 14. The amount of air blown into the vial 27 has now adjusted the air pressure in the vial so that no disadvantage of underpressure in the vial 27 is experienced when the piston 35 is pulled out. Injection liquid 39 is now located above the piston 35, up to the tip 38 of the injection needle 37. The air pressure in the vial 27 is regulated.
In step 7, see figures 15 and 16, the plunger 35 is pulled downwards by the further mechanical displacing means until slightly more than the ultimately desired amount of injection liquid 39 has been drawn into the syringe 23 . This often creates an undesirable air bubble 49 in the top corner of the cylindrical part 51 of the housing 45 directly below the neck 53 of the housing 45. With the following steps, this air bubble 49, that can be present, is removed from the syringe 23.
In step 8, see figures 17 and 18, the vial 27 is pulled from the syringe 23 by the mechanical displacement means until the tip 38 of the injection needle 37 is out of the vial 27 and is in the air. Alternatively, the vial 27 may be pushed further down over the injection needle 37 until the tip 38 of the injection needle 37 is in the air in the vial 27. Subsequently, in step 9, air 41 is drawn into the syringe 23 by further pulling out the plunger 35 by the further mechanical displacing means. The plunger 35 is pulled out that much that air 41 is sucked into the cylindrical part 51 of the housing 45 of the syringe 23 so that the air bubble 49 merges with the sucked air, see figure 18.
In step 10 of the method, see figures 19 and 20, the vial 27 is pressed onto the injection needle 37 by the mechanical displacement means until the tip 38 of the injection needle 37 enters the injection liquid 39 in the vial 27. Finally, in step 11, see figures 21 and 22, of the method the plunger 35 is pushed further into the housing 45 by the further mechanical displacement means, until the desired amount of injection liquid 39 remains in the syringe 23.
Although the present invention is elucidated above on the basis of the given drawings, it should be noted that this invention is not limited whatsoever to the embodiments shown in the drawings. The invention also extends to all embodiments deviating from the embodiments shown in the drawings within the scope of the invention defined by the appended claims.

Claims

CLAIMS:
1. A device (1) for automatically filling syringes (23) with injection liquid, comprising: a syringe holder (17) for several syringes (23) provided with injection needles (37), a vial holder (25) for a vial (27) with injection liquid, displacement means for displacing the vial holder (25) and the syringe holder (17) relative to each other in order to successively get each of the injection needles (37) into the injection liquid contained in the vial (27), and pull-out means for moving a plunger (35) of a syringe (23) in a cylindrical housing (33) of the syringe (23) in order to get the injection liquid from the vial
(27) into the respective syringe (23), characterized in that the device (1) further comprises: input means (9) for inputting data concerning the vial (27) to be used, syringe (23) and injection needle (37), a processor (8) for controlling the displacing means and the pull-out means, and a data storage unit (10) which is connected to the processor (8) for data exchange and which contains data for each type of vial (27) relating to the actuation of the displacement means and the pull-out means.
2. Device (1) according to claim 1, characterized in that the processor is configured to store data concerning the filling of syringes (23) with injection liquid in the data storage unit (10) for later use for checking and analysis.
3. Device (1) according to claim 1 or 2, characterized in that the device (1) is provided with data exchange means (12) for updating the data present in the data storage unit (10).
4. Device (1) according to claim 1, 2 or 3, characterized in that the syringe holder (17) is removably present in the device (1) and is provided with an identifier (18), wherein the device (1) has recognition means (20) capable of reading the identifier (18) and storing it in the data storage unit (10) and linking it to the input data of the used vial (27), syringe (23) and injection needle (37).
5. Device (1) according to any one of the preceding claims, characterized in that the vial holder (25) is configured to accommodate vials (27) of different sizes.
6. Device (1) according to any one of the preceding claims, characterized in that: the syringe holder (17) is fixed in the device during use, the displacing means and the pull-out means are present on a carriage (13), and the device (1) further comprises carriage means for moving the carriage (13) along the syringe holder (17) and successively positioning the carriage (13) relative to each syringe (23) present in the syringe holder (17).
7. Device (1) according to claim 6, characterized in that in the device (1) two syringe holders (17) can be fixed parallel to one another and at a distance from each other and the carriage (13) can be moved between the two syringe holders (17) and for each of the syringe holders (17) is provided with displacing means and pull-out means.
8. Device (1) according to claim 7, characterized in that the displacing means are displaceable simultaneously and that the pull-out means are displaceable simultaneously.
9. Device (1) according to claim 6, 7 or 8, characterized in that the vial holder (25) is configured to hold a vial (27) at an angle to the vertical direction.
10. Device (1) according to any one of the preceding claims, characterized in that the syringe holder (17) is formed by a form-retaining, straight, elongate tray (31) with several clamping elements (21) for syringes (23) arranged side by side in the longitudinal direction.
11. Device (1) according to claim 10, characterized in that during use in a horizontal direction, the clamping elements (21) are offset from each other perpendicular to the longitudinal direction of the tray (31) so that the clamping elements (21) are not in a straight line.
12. Device (1) according to any one of the preceding claims 6-11, characterized in that the carriage means are configured to move the carriage (13) in the longitudinal direction of the syringe holder (17) in each case over a distance that is slightly different from the distance between adjacent syringes (23), wherein these distances differ slightly from each other.
13. Device (1) according to any one of the preceding claims 6-12, characterized in that the pull-out means are configured to first pull out the plunger (35) when filling a syringe (23), such that there is too much injection liquid in the syringe (23) and then push back the plunger (35) until the desired amount of injection fluid remains in the syringe (23).
14. A method of mechanically filling a syringe (23) provided with an injection needle (37) with injection liquid (39) contained in a vial (27), said vial (27) having an opening closed by a pierceable and self-sealing layer (43), and the syringe (23) comprises a housing (45) and a plunger (35) therein which is movable between a maximally depressed position and a maximally pulled out position, the housing (45) being a cylindrical member (51) in which the plunger (35) is movable, as well as a neck part (53) connected to the cylindrical part (51) and having a smaller cross section than the cylindrical part (51) and an injection needle (37) connected to the neck part (53), wherein with the layer (43) of the vial (27) facing down (43), the method comprises the following steps: with the plunger (35) in the maximum depressed position, insert the injection needle (37) through the layer (43) or pressing the vial (27) over the injection needle (37) until the open end of the injection needle (37) is in the injection fluid (39) by moving the syringe (23) and the vial (27) relative to each other by mechanical displacement means, pulling out the plunger (35) over a first distance, wherein the air (41) present above the plunger (35) and in the injection needle (37) can form an air bubble (47) on the plunger (35) and the remaining space above the plunger (35) and in the injection needle (37) is filled with injection liquid (39) by moving the plunger (35) and the housing relative to each other by the mechanical displacement means, pulling the syringe (23) from the vial (27) or pulling the vial (27) from the injection needle (37) until the open end of the injection needle (37) is out of the injection fluid (39) by displacing the syringe (23) and the vial (27) relative to each other by means of mechanical displacement means, pulling the plunger (35) further over a second distance at a second speed greater than the first speed, wherein, in case an air bubble (47) is formed on the plunger (35), the air bubble (47) becomes detached from the plunger (35) and in the injection needle (37) and directly below the injection needle (37) merges with the aspirated air (41) by displacing the plunger (35) and the housing by the mechanical displacement means relative to each other, inserting the injection needle (37) into the vial (27) or pushing the vial (27) over the injection needle (37) until the open end of the injection needle (37) is in the injection fluid (39) by displacing the syringe (23) and the vial (27) relative to each other by mechanical displacement means, before or after introducing the open end of the injection needle (37) into the injection fluid (39) depressing the plunger (35) until all air is out of the syringe (23) by displacing the plunger (35) and the housing relative to each other by the mechanical displacement means, pulling the plunger (35) downwards until more than the desired amount of injection liquid (39) is present in the syringe (23) by moving the plunger (35) and the housing relative to each other with the aid of the mechanical displacement means; move, moving the vial (27) and the syringe (23) relative to each other by the mechanical displacement means until the tip (38) of the injection needle (37) is above the injection liquid (39) in the vial (27) or outside the vial (27) in the air, moving the plunger (35) and the housing relative to each other by the further mechanical displacement means, wherein the plunger (35) gets further out of the housing (45) over a distance sufficient to suck the sucked air into the cylindrical part (51) of the housing (45), moving the vial (27) and the syringe (23) relative to each other by the mechanical displacement means until the tip (38) of the injection needle (37) gets in the injection liquid (39) in the vial (27), and moving the plunger (35) and the housing relative to each other by the further mechanical displacement means, wherein the plunger (35) moves further into the housing until the desired amount of injection liquid (39) remains in the syringe (23).
15. Method according to claim 14, characterized in that the displacement of the syringe (23) and the vial (27) relative to each other is carried out by mechanical displacement means by holding the syringe (23) stationary and moving the vial (27).
16. Method according to claim 14 or 15, characterized in that the displacement of the plunger (35) and the housing (45) relative to each other by the mechanical displacement means is effected by holding the housing (45) stationary and moving the plunger (35).
EP22723488.7A 2021-03-15 2022-03-15 Device for the automatic filling of syringes with injection liquid Pending EP4308461A2 (en)

Applications Claiming Priority (3)

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NL2027758A NL2027758B1 (en) 2021-03-15 2021-03-15 Device for automatic filling of syringes with injection liquid
NL2029520 2021-10-27
PCT/NL2022/050141 WO2022197181A2 (en) 2021-03-15 2022-03-15 Device for the automatic filling of syringes with injection liquid

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EP4299457A1 (en) * 2022-07-01 2024-01-03 Kiro Grifols, S.L. Machine for the preparation of medical product with removable device for loading medical containers
NL2034052B1 (en) * 2023-01-30 2024-08-22 Rockmed Pharma B V Device and method for fluid transfer between syringes

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TWI233815B (en) * 2004-02-06 2005-06-11 Shr Ji Tau Injector of injection system for nuclear radioactive medicament and automatic feeding device for physiological saline cartridge
US7913720B2 (en) * 2006-10-31 2011-03-29 Fht, Inc. Automated drug preparation apparatus including serial dilution functionality
US8286671B1 (en) * 2011-03-23 2012-10-16 Saverio Roberto Strangis Automated syringe filler and loading apparatus
US10576211B2 (en) * 2018-01-12 2020-03-03 Becton, Dickinson And Company Medication dispensing system

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