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NL2033713B1 - Method and device for filling syringes - Google Patents

Method and device for filling syringes Download PDF

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Publication number
NL2033713B1
NL2033713B1 NL2033713A NL2033713A NL2033713B1 NL 2033713 B1 NL2033713 B1 NL 2033713B1 NL 2033713 A NL2033713 A NL 2033713A NL 2033713 A NL2033713 A NL 2033713A NL 2033713 B1 NL2033713 B1 NL 2033713B1
Authority
NL
Netherlands
Prior art keywords
syringe
buffer member
frame
liquid
volume
Prior art date
Application number
NL2033713A
Other languages
Dutch (nl)
Inventor
Schootstra Joost
Martijn Visser Sietse
Original Assignee
Sjj Solutions B V
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 Sjj Solutions B V filed Critical Sjj Solutions B V
Priority to NL2033713A priority Critical patent/NL2033713B1/en
Priority to PCT/NL2023/050654 priority patent/WO2024128913A1/en
Application granted granted Critical
Publication of NL2033713B1 publication Critical patent/NL2033713B1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2096Combination of a vial and a syringe for transferring or mixing their contents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2079Filtering means
    • A61J1/2086Filtering means for fluid filtration
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M2005/3114Filling or refilling
    • 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
    • A61M2209/00Ancillary equipment
    • A61M2209/04Tools for specific apparatus
    • A61M2209/045Tools for specific apparatus for filling, e.g. for filling reservoirs

Landscapes

  • Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Physics & Mathematics (AREA)
  • Fluid Mechanics (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

A device for filling a syringe, the device comprising a frame and a buffer member comprising a buffer body defining an intermediate volume for receiving a fluid therein, a fluid inlet in fluid communication with the intermediate volume, a fluid outlet in fluid communication with the intermediate volume, and a syringe connector for connecting a syringe to the buffer member such that the syringe is in fluid communication with the fluid outlet; wherein the buffer member is rotationally connected to the frame such that the buffer member can be rotated relative to the frame between a first rotation position wherein the fluid outlet is positioned above a liquid level in the intermediate volume, and a second rotational position wherein the fluid outlet is positioned below a liquid level in the intermediate volume.

Description

P133957NL00
Title: Method and device for filling syringes
TECHNICAL FIELD
The aspects and embodiments thereof relate to the field of syringes, in particular for administering liquid medication.
BACKGROUND
Liquid medication may be supplied in glass ampoules. These ampoules are usually broken open by hand and the medication is then drawn up into a syringe. Particularly when the medication is administered intravenously, patient safety issues may occur if the liquid medication is contaminated with glass micro-particulate or miniscule glass shards originating from the breaking of the ampoule.
Liquid medication may be supplied in vials which are sealed with a rubber stopper. Coring is a known problem with these vials, wherein a small piece of the rubber stop breaks after puncturing the rubber stopper with a needle. This small piece of rubber may contaminate the liquid medication. As the piece of rubber may be very small, it may remain unnoticed and may cause harm to a patient when the piece of rubber is injected together with the liquid medication.
To filter out any contaminants, such as glass micro-particulate or rubber pieces, a filter needle may be used for drawing up the medication from the glass ampoule or vial into the syringe. The filter needle for example comprises a 5 micron filter, which catches the glass or rubber particles as the liquid medication is pulled through it.
After the liquid medication has been drawn into the syringe, the filter needle is discarded and a non-filter needle is coupled to the syringe in order to administer the medication.
SUMMARY
It has been observed that when using a needle — in particular but not limited to a filter needle - to pull liquid medication into a syringe, air is also drawn into the syringe. This air needs to be removed from the syringe prior to administering the liquid medication. Pointing the syringe upwards and tapping the syringe may remove air trapped in the liquid medication in the syringe. It has been observed that when removing air from the syringe, also some of the liquid inside the syringe is typically lost.
Instead of liquid medication, any other liquid may also be drawn into a syringe. For other Liquids, it may also be required to remove air trapped in the liquid inside the syringe. This especially holds for expensive or rare
Liquids, with a high cost per unit, in particular per unit volume like litre or millilitre, which makes wasting the liquid even less desirable. Examples of expensive and/or rare liquids are liquid medicaments, in particular vaccines or medicaments, in particular medicaments for intravitreal injection.
It has been observed that when the diameter of the syringe, in particular of the main volume of the syringe, is too small, air may remain trapped with the liquid medication inside the syringe. This may for example be caused by the viscosity of the liquid medication. It is preferred to provide for a method and/or device to administer filtered liquid medication essentially without air trapped therein, in particular using a syringe with a small diameter, in particular with a small inner diameter.
NL2029329 (not published at the date of filing of the present application) proposes a method of filling a syringe with a liquid. The method comprises the steps of filling an intermediate volume of a buffer member with the liquid, optionally emptying a main volume of a syringe, drawing the liquid from the intermediate volume of the buffer member into the main volume of the syringe such that the main volume is essentially free of air, and disconnecting the buffer member from the syringe.
Although the method of NL2029329 provides very good results in obtaining a syringe with a main volume that is filled with a liquid and is essentially free of air, it remains an object to improve the process of filling syringes with liquid without trapping air in the liquid. Improvements may be desired for example in terms of speed of filling the syringes and/or the precision and/or accuracy of the volume of liquid with which one or more syringes can be filled.
A first aspect provides a device for filling a syringe. The device comprises a frame and a buffer member. The buffer member comprises a buffer body defining an intermediate volume for receiving a fluid therein, a fluid outlet in fluid communication with the intermediate volume, a fluid inlet in fluid communication with the intermediate volume, and a syringe connector for connecting a syringe to the buffer member such that the syringe is in fluid communication with the fluid outlet. The buffer member is rotationally connected to the frame such that the buffer member can be rotated relative to the frame between a first rotation position wherein the fluid outlet can be or is positioned above a liquid level in the intermediate volume, and a second rotational position wherein the fluid outlet can be or is positioned below a liquid level in the intermediate volume.
When the fluid outlet is positioned below a liquid level in the intermediate volume, the entire fluid outlet may be surrounded with Liquid instead of with air. Consequently, it can be prevented that air is drawn into the syringe.
Preferably, but not necessarily, in the second rotational position the fluid inlet is positioned above the syringe connector and/or the fluid inlet is positioned above the fluid outlet. This allows air as an example of a fluid to enter the buffer member without entering the syringe when liquid is drawn into the syringe, which in turn can prevent a vacuum in the buffer member when liquid 1s drawn into the syringe.
Because the buffer member is rotationally connected to the frame, the buffer member can be attached to and supported by the frame, while it also possible to rotate the buffer member from a first rotational position in which a syringe can be connected or disconnected, and a second rotational position in which the syringe can be filled with liquid from the buffer member.
As such, filling of the syringe can become faster, more accurate, and/or more precise. Furthermore, the filling process can be conveniently repeated for filling multiple syringes, in particular with the same volume of the same liquid, preferably from the same buffer member.
When the fluid inlet is positioned above the syringe connector and/or the fluid inlet is positioned above the fluid outlet, it may be prevented that air is drawn into the syringe when liquid is also drawn from the buffer member into the syringe.
The buffer member is preferably partially filled with a liquid medicament. In many situations, the buffer member is also partially filled with air. However, when the buffer member is in the second rotational position, by virtue of gravity the liquid inside the buffer member will flow or will have flown towards the fluid outlet such that liquid can be drawn into a syringe instead of air.
As a particular option applicable to any device disclosed herein, the device may comprise a receptacle, which receptacle is rotationally connected to the frame, and the buffer member is at least partially positioned in the receptacle such that the buffer member is rotationally connected to the frame via the receptacle. As such, the buffer member may be released from the device and conveniently replaced with another buffer member. This may decrease the need to clean the device, and/or allows different buffer members to be used for different types of liquids.
When the device comprises the receptacle, the buffer member may thus be indirectly connected to the frame. Alternatively, for any device disclosed herein, the buffer member may be directly rotationally connected to the frame — i.e. without the buffer member being temporarily placed in a receptacle.
The rotation of the buffer member relative to the frame may be about a generally horizontal rotation axis, or conceivable any other rotation axis at an angle relative to the horizon.
For example to allow for precise and/or accurate filling of one or multiple syringes, any embodiment of the device disclosed herein may comprise a plunger guide arranged to engage a plunger of a syringe, which plunger guide is moveably connected to the frame such that the plunger guide 5 can be translated between a proximal position and a distal position, wherein in the proximal position, a distance between the plunger guide and the buffer member 1s smaller than the distance between the plunger guide and the buffer member in the distal position of the plunger guide.
By virtue of the plunger guide, instead of directly actuating the plunger of the syringe, the plunger of the syringe may be actuated by actuating the plunger guide.
When any device disclosed herein comprises a plunger guide, the device may further comprise a stopping member defining the distal position of the plunger guide. Preferably, but not necessarily, the stopping member may be releasably connected to the frame such that a position of the stopping member relative to the buffer member can be adjusted. When the stopping member can be positioned in different positions relative to the buffer member, the stopping member can be set to fill the syringe with a particular volume of liquid. By keeping the stopping member in the same position, multiple syringes can be filled with same volume of liquid with increased precision.
Optionally, a biasing member may be used for biasing the plunger guide into the proximal position. After drawing liquid into the syringe, the plunger guide may thus be automatically moved back into the proximal position by the biasing member.
In general, the different embodiments of the device for filling a syringe as disclosed herein may be manually operated by a user. For example, the user may manually rotate the buffer member relative to the frame and/or move the plunger of the syringe to draw liquid into the syringe, optionally using a plunger guide.
However, also embodiments of the device are envisioned wherein one or more steps required for filling the syringe are automated.
For example, embodiments of the device may comprise a rotational actuator, such as an electric motor, for rotating the buffer member relative to the frame. Additionally, or alternatively, the device may comprise a plunger guide actuator, such as a linear actuator, for example an electric or pneumatic actuator, for moving the plunger guide relative to the frame.
Generally, for example when the device comprise one or both of the rotational actuator and the plunger guide actuator, the device may further comprise a controller, for example an electronic controller, for controlling the one or both of the rotational actuator and the plunger guide actuator. The controller may for example control the one or both of the rotational actuator and the plunger guide actuator based on a user input. The user input may relate to a filling action, and may even relate to a filling action with a particular desired volume of liquid with which the syringe is to be filled.
A second aspect provides an assembly for filling a syringe, the assembly comprising any device according to the first aspect, and a syringe.
The syringe is connected or connectable to the syringe connector of the buffer member. As such, the syringe can be filled using the device, or even by the device.
For any assembly disclosed herein, a size of the intermediate volume may approximately correspond to more than two times a size of a main volume of the syringe, preferably even five times more. As such, multiple syringes may be filled from the same intermediate volume without having to refill the intermediate volume in-between filling of different syringes.
For any assembly disclosed herein, the intermediate volume of the buffer member may be filled with a volume of liquid medicament which exceeds the size of the main volume of the syringe, in particular two times or more or even five times or more. The liquid medicament may be a filtered liquid medicament.
A third aspect provides a method of filling a syringe. In any method according to the third aspect, any device according to the first aspect may be used. Any method step disclosed herein may be generally performed by a human operator and/or by the device itself, in any combination thereof.
The method according to the third aspect comprises steps of: - connecting a syringe to a syringe connector of a buffer member, such that a main volume of the syringe is in fluid communication with an intermediate volume of the buffer member, which intermediate volume is at least partially filled with a liquid, such as but not limited to a liquid medicament; - rotating the syringe and the buffer member from a first rotational position to a second rotational position relative to a frame of a device for filling a syringe, to which frame the buffer member is rotationally connected, such that a fluid inlet of the buffer member is positioned above the syringe and/or a fluid outlet of the buffer member is positioned below a liquid level of liquid in the buffer member; - drawing a volume of liquid from the intermediate volume into the main volume of the syringe through the fluid outlet, such that the main volume is essentially free of gasses such as air; - optionally rotating the syringe and the buffer member relative to the frame from the second rotational position to or towards the first rotational position or to a third rotational position; and - disconnecting the syringe from the buffer member.
Preferably, but not necessarily, in the first rotational position, the syringe is oriented generally horizontally. This may generally allow the intermediate volume to be filled with the most amount of liquid without liquid leaking out of the buffer member, for example through the fluid outlet and/or the fluid inlet.
Furthermore preferably, but not necessarily, in the second rotational position, the syringe is oriented generally vertically. This may ensure that only liquid is drawn into the syringe, and no air, since the fluid outlet may be completely surrounded with liquid in this second rotational position.
In any embodiment of the method, the method may further comprise positioning at least part of the buffer member in a receptacle of the device for filling the syringe.
Generally, a flow of fluid such as air may be allowed into the intermediate volume through the fluid inlet while drawing the volume of
Liquid from the intermediate volume into the main volume of the syringe. This may prevent the pressure in the intermediate volume to be lowered while drawing liquid from the intermediate volume, which in turn may increase the ease with which liquid can be drawn into the syringe.
In the present disclosure, wherever a fluid is mentioned, the term fluid may mean one or more liquids, one or more gasses, or any combination thereof. The liquid may in particular be a liquid medicament. The liquid medicament may be intended for intravenous injection into a human or animal. The gas may in particular be air.
For example when the liquid is a liquid medicament, the liquid may be supplied in a glass ampoule or vial. A liquid medicament may be for example be a medicine, a vaccine, or any other liquid used in medical applications. When transferred from the glass ampoule or vial into the buffer member, the liquid medicament may pass through a filter, such as a filter of a filter needle.
The volume of liquid drawn into the main volume of the syringe may be less than 60 mL, less than 10 mL, less than 0.5 mL, less than 0.2 mL or even less than 0.1 mL or less than 0.05 mL. Especially when using syringes with a small main volume, trapped air may be hard to remove from the syringe, for example by tapping the syringe with the tip pointed upward.
In general, for any syringe of the present disclosure, the syringe may comprise an elongated syringe body defining the main volume. As an option, a maximum cross-sectional area of the intermediate volume of the buffer body is larger than a maximum cross-sectional area of the main volume of the syringe in a direction perpendicular to an elongation direction of the syringe body, in particular at least two times larger. A maximum cross-
sectional area may for example be defined by a maximum diameter in case of an approximately circular cross-sectional area.
Additionally or alternatively, the maximum cross-sectional area of the main volume may be less than 25 mm?2, for example less than 20 mm?, as another example less than 17 mm? and as yet another example less than 15 mm? and the maximum inner cross-sectional area of the intermediate volume is less than 2-10: mm?2, for example equal to or less than 1.2 10? mm?, equal to or less than 5.7 -102 mm? or equal to or less than 1.8 102 mm?, corresponding to an inner diameter of 39 millimetres, 27 millimetres and 15 millimetres.
At least part of an inner surface, or an entire inner surface arranged to contact liquid medicament in use, of the buffer body facing the intermediate volume may be a hydrophobic surface. A hydrophobic surface may be defined as a surface which has a physical property of repelling water.
A surface may be hydrophobic by virtue of the material providing the surface consisting of or comprising one or more hydrophobic materials, and/or by any structural or chemical modification of the surface to make the surface hydrophobic. A hydrophobic surface may in embodiments be provided by a hydrophobic coating on a substrate surface, for example part of the buffer member, which substrate surface is not necessarily hydrophobic.
To prevent contamination of liquid inside the intermediate volume, in particular liquid medicament, an inner surface of the buffer body facing the intermediate volume may be essentially free of liquid lubricants such as silicone oil.
A size of the intermediate volume may approximately correspond to more than two times a size of the main volume, preferably even five times or more. As such, in a single intermediate volume, sufficient liquid may be stored for filling a plurality of main volumes of a plurality of syringes. A size may be understood as a storage volume available for storing fluid, in particular Liquid.
BRIEF DESCRIPTION OF THE FIGURES
In the figures:
Figs. 1-7 generally depict a device for filling a syringe during different steps of a method of filling a syringe;
Fig. 8A shows a buffer member in a section view;
Figs. 8B and 8C show a buffer member and a syringe in a section view; and
Fig. 9 schematically shows another device for filling a syringe.
DETAILED DESCRIPTION OF THE FIGURES
Figs. 1-7 generally depict a device 100 for filling a syringe 300, shown in consecutive method steps of filling the syringe 300. When the syringe 300 is connected or coupled to the device 100, the syringe 300 and the device 100 together form a filling assembly 102. Although Figs. 1-7 depict a particular embodiment, it will be appreciated that this embodiment may be readily amended by adding or removing one or more of the optional features as disclosed herein.
Generally, the device 100 comprises a frame 104. By virtue of the frame 104, the device 100 may for example be positioned on a working surface such as a table top. The frame 104 may comprise a vertical portion and a base part 106, which may be a generally horizontal base part 106. Although in
Figs. 1-7 the same frame 104 is depicted, it will be appreciated that devices 100 are envisioned with differently shaped and/or formed frames. For example, a frame may be an at least partially open frame formed for example by interconnected beams.
The device further comprises an optional receptacle 108 for receiving at least part of a buffer member therein. The receptacle 108 is rotationally connected to the frame 104. When the device 100 does not comprise the receptacle, the device 100 may comprise the buffer member and the buffer member itself can be rotationally connected to the frame 104. For example, when the device 100 does not comprise the receptacle, the buffer member may be rotationally fastened to the frame. Typically, such fastening is not intended to be released by a user in normal use of the device for filling syringes.
Fig. 1 shows the device 100 before a buffer member has been positioned in the receptacle 108. In Fig. 1, the receptacle 108 is in a receiving state. In the receiving state, a user or conceivably another device can position a buffer member in the receptacle 108. To hold the buffer member in the receptacle 108, the device 100 may comprise a restriction member 110. When the buffer member is positioned in the receptacle 108, the buffer member is preferably at least partially filled with a liquid medicament, in particular a filtered liquid medicament previously supplied in a glass ampoule or vial.
Fig. 2 shows the device 100 after a method step of positioning at least part of the buffer member 200 in the receptacle 108 of the device 100 for filling the syringe. The buffer member 200 comprises a buffer body defining an intermediate volume for receiving a fluid therein. In the particular embodiment of the buffer member 200 depicted in the figures, the buffer member comprise a fluid inlet 204 on one side, and a syringe connector 206 on an opposite side of the buffer body. The syringe connector 206 surrounds a fluid outlet 202. As an option, the syringe connector 206 may comprise a thread, for example a thread commonly associated with a Luer-lock connection.
To prevent the buffer member 200 from accidentally being removed from the receptacle, in Fig. 2, the restriction member 110 is shown in a locking state. For example, to move the restriction member 110 from the open state of Fig. 1 into the locking state of Fig. 2, the restriction member 110 may be hinged relative to the frame 104.
As an option shown in the figures, the restriction member 110 comprises a screw 112 which can be screwed into a threaded opening 114 of the frame 104. As other options, the restriction member may be snap-fitted, clamped, and/or otherwise screwed in place.
When the buffer member 200 is positioned in the receptacle, as for example depicted in Fig. 2, preferably the syringe connector 206 is exposed such that is easy for a user to connected a syringe to said syringe connector 206. The fluid inlet 204 is preferably exposed to allow a flow of air through said fluid inlet 204, in particular when the buffer member 200 is in the second rotational position.
Alternatively, for any device 100 disclosed herein, a filter needle may be connected to the fluid inlet 204. As such, a filtered flow of fluid, such as a filtered flow or air, may pass through the fluid inlet 204 into the intermediate volume.
As a further alternative, a cap or seal may be placed onto or into the fluid inlet 204 to block any fluid flow through the fluid inlet 204.
Prior to positioning the buffer member 200 in the receptacle, the buffer member 200 may have been filled with a liquid, such as a liquid medicament. For filling the buffer member 200, a needle may be connected to the fluid inlet 204 and a syringe may be connected to the fluid outlet. When the needle is then submerged into a liquid, which can for example be supplied in a glass vial or ampoule, liquid can be drawn into the buffer member 200 using the syringe. When the needle is a filter needle, the liquid is first filtered and the buffer member 200 can thus be filled with a filtered liquid, such as a filtered liquid medicament. It will thus be appreciated that in any embodiment of the buffer member disclosed herein, the buffer member can be at least partially filled with a filtered liquid, in particular a filtered liquid medicament.
Fig. 3 shows the device 100 after a method step of connecting a syringe 300 to the syringe connector 206 of the buffer member 200, such that a main volume of the syringe is in fluid communication with an intermediate volume of the buffer member, which intermediate volume is at least partially filled with a liquid. As such, the assembly 102 has been formed.
In Fig. 3, the syringe 300 is in a first rotational position relative to the frame 104. Preferably, the first rotational position corresponds to the horizontal position of the syringe 300 shown in Fig. 3. However, in other embodiments, in the first rotational position, the syringe 300 may be oriented at an angle relative to horizontal.
In Figs. 2 and 3, the buffer member is in a first rotational position relative to the frame 104, which preferably but not necessarily corresponds to a horizontal position. In the first rotational position, the fluid inlet 204 and the fluid outlet 202 are aligned on a horizontal line. As such, it may be prevented that liquid inside the buffer member 300 spills out of the fluid inlet 204 and/or fluid outlet 202, and/or to optimise the volume of liquid with which the buffer member can be filled.
Although the buffer member 200 is in the figures shown as being generally symmetric, other shapes of buffer members are envisioned as well.
For example, a bottom part which in the first rotational position is below the fluid inlet 204 and the fluid outlet 202 may be larger than an upper part of the buffer member which in the first rotational position is above the fluid inlet 204 and the fluid outlet 202. At least part of this bottom part may in use be filled with liquid, whereas the upper part is typically not filled with liquid in the first rotational position, but may instead be filled with air.
As shown in Fig. 3, typically, when the syringe 300 is first connected to the buffer member 200, a plunger of the syringe 300 is preferably fully depressed such that a main volume of the syringe is substantially equal to 0 mL, or at least essentially free of air.
The syringe 300 comprises a plunger 302 which can be operated to move a piston of the syringe 300, and the syringe 300 typically also comprises a grip 304. The grip 304 may be formed as one or more generally radial protrusions protruding from the body of the syringe 300. In use, a user of the syringe may press their thumb on the plunger 302 while hooking one or more other fingers behind the grip 304.
Fig. 4 shows the assembly 102 after a method step of rotating the syringe 300 and the buffer member 200 from the first rotational position to a second rotational position relative to the frame 104 of the device 100 for filling a syringe, to which frame the buffer member is rotationally connected, such that a fluid inlet 204 of the buffer member 200 is positioned above the syringe 300. In Fig. 4, the fluid inlet 204 and the syringe 300 are generally aligned on a vertical line. However, in other envisioned embodiments, the fluid inlet 204 and the syringe 300 are not necessarily aligned on a vertical line.
By virtue of gravity, in the second rotational position, liquid in the buffer member 200 is positioned adjacent to the fluid outlet 202. The liquid pushes away any air which may have been present adjacent to the fluid outlet 202 in the first rotational position and optionally while transitioning the buffer member 200 from the first rotational position to the second rotational position.
In the second rotational position of the syringe 300, as shown in
Fig. 4, part of the syringe 300, in particular the grip 304, is in engagement with a grip hold 122 of the device 100. Embodiments of the device 100 are also envisioned without the grip hold 122. However, when the grip hold 122 is used, the syringe 300 and in particular the syringe body to which the grip 304 is connected can be fixed relative to the frame 104 of the device via the grip hold 122. This may result in less forces and/or stresses on the syringe connector 206. The grip hold 122 is preferably rigidly connected to the frame 104 or even integrally formed with the frame 104. The grip hold 122 may have a reception volume 305 complementary to at least part of the grip 304 to receive at least part of the grip 304 in the reception volume when the syringe is rotated into the second rotational position. Preferably, the grip hold 122 restricts or prevents movement of the grip 304 of the syringe 300 in a vertical direction.
As shown in Fig. 4, in the second rotational position, the plunger 302 of the syringe 300 is in engagement with a plunger guide 120 of the device 100. By virtue of being in engagement, a movement of the plunger guide 120 can result in a movement of the plunger 302, in particular a downward movement of the plunger guide 120. Because the grip 304 of the syringe 300 1s held by the grip hold 122 and/or the syringe 300 is connected to the syringe connector 206 of the buffer member 200, the plunger 302 can be moved relative to the body of the syringe 300. With this movement of the plunger 302 relative to the body of the syringe 300, liquid can be drawn into the main volume of the syringe.
The plunger guide 120 is preferably slideably connected to the frame 104 such that the plunger guide 120 can be translated between a proximal position (as shown in Fig. 4) and a distal position (as shown in Fig. 5). As can be seen in Figs. 4 and 5, in the proximal position, a distance between the plunger guide 120 and the buffer member 200 is smaller than the distance between the plunger guide 120 and the buffer member 200 in the distal position of the plunger guide 120. A sliding guide 127 may be comprised or connected to the frame 104 to guide the translation of the plunger guide 120.
Fig. 5 shows the assembly 102 after a method step of drawing a volume of liquid from the intermediate volume of the buffer member 200 into the main volume of the syringe 300, such that the main volume is essentially free of gasses such as air. The drawing of the volume of liquid is performed by a movement of the plunger guide 120 in a direction generally away from the buffer member 200. Because the plunger 302 is in engagement with the plunger guide 120, the plunger 302 is moved together with the plunger guide 120.
As for example shown in Fig. 5, the device 100 may comprise an optional stopping member 124. The stopping member 124 may be used to define the distal position of the plunger guide 120 and/or the plunger 302.
Figs. 5 and 6 show that in the distal position, the plunger 302 is pressed or positioned against the stopping member 124. In other embodiments, in the distal position, additionally or alternatively the plunger guide 120 1s pressed or positioned against the stopping member 124.
Preferably, but not necessarily, the position of the stopping member 124 relative to the buffer member 200 and/or the frame 124 can be adjusted. By adjusting the position of the stopping member 200 relative to the buffer member 200 and/or the frame 124, the volume of liquid drawing into the syringe by moving the plunger guide 120 to the distal position can be set.
When this volume of set, multiple syringes can be filled with the same volume by maintaining the position of the stopping member 124.
Generally, the stopping member 124 may be formed by a protruding part of the frame 104 or by a separate stopping member 124 connected to the frame 104, optionally moveably connected to the frame 104.
In the embodiment of the device 100 shown in Fig. 1, the stopping member 124 is clamped onto the frame using a clamp 129. The clamping force clamping the stopping member 124 to the frame 124 can be released for example by rotating a screw knob, and the position of the stopping member 124 can then be adjusted. It will be appreciated that many other options are envisioned that allow the position of the stopping member 124 to adjusted relative to the frame.
Fig. 6 shows the assembly 102 after a method step of moving the plunger guide 120 back to the proximal position. Compared to the situation of Fig. 5 the plunger 302 is however not moved. Thus, it will be appreciated that preferably the plunger guide 120 is arranged to move the plunger 302 in a direction away from the buffer member 200, but that the plunger 302 does not move together with the plunger guide 120 is a direction towards the buffer member 200. A movement of the plunger 302 in the direction towards the buffer member 200 may result in liquid being inadvertently expelled from the syringe 300 back into the buffer 200.
The plunger guide 120 may be moved back to or towards the proximal position by a manual operation. Additionally or alternatively, the device 100 may comprise one or more biasing elements (not shown) for biasing the plunger guide 120 into the proximal position. Even further additionally or alternatively, an actuator may be provided for moving the plunger guide 120.
Fig. 7 shows the assembly 102 after a method step of rotating the buffer member 200 back to the first rotational position, with the filled syringe
300 still connected to the buffer member 200. Generally, the filled syringe 300 is disconnected when the buffer member 200 1s in the first rotational position.
However, it is also envisioned that the syringe is disconnected in any other rotational position of the buffer member 200. For example, the buffer member 200 may be rotated to a third rotational position beyond that second rotational position, for example further clockwise, or to a third rotational position in-between the first and second rotational positions. Generally, the rotational direction from the first rotational position to the second rotational position may be in a clockwise or anti-clockwise direction. The rotational direction from the second rotational position to an optional third rotational position may also be in a clockwise or anti-clockwise direction.
Fig. 8A shows an example of a buffer member 200, and Figs. 8B and 8C show an assembly 101 of a buffer member 200 and a syringe 300. For conciseness and clarity of the figures, the buffer member and syringe are shown separate from the device 100 in Figs. 8A-8C. However, it will be appreciated that the buffer member 200 as depicted in Figs. 8A-8C may be readily comprised or connected to any of the devices for filling a syringe as disclosed herein.
Fig. 8A shows the buffer member 200 in a first rotational position, similar to for example Figs. 2 and 3. The buffer member 200 comprises a buffer body 201 defining an intermediate volume 203 therein. The intermediate volume 203 is partially filled with a liquid 400, such as a liquid medicament, up to a particular level 402. Preferably, in the first rotation position, the liquid level 402 is below the fluid outlet 202 and the fluid inlet 204 to prevent leakage.
As an option shown in Fig. 8A, the fluid inlet 204 1s formed by a fluid inlet protrusion 240 of the buffer body 201. The fluid inlet protrusion 240 may be arranged for having a needle, such as a filter needle, connected thereto for example using a screw or interference-fit connection. As such, the buffer member may be filled by drawing liquid into the buffer member through a needle connected to the fluid inlet protrusion and through the fluid inlet 204.
Figs. 8B and 8C show a syringe 300 connected to the buffer member 200, in particular to the syringe connector 206. In this example, as an option also applicable for any other syringe connector 206, for any device disclosed herein, the syringe 300 is connected with an interference fit to the syringe connector 206, for example as a Luer-slip connection.
Between the situations depicted in Figs. 8B and 8C, the liquid 400 from the intermediate volume 203 of the buffer member 200 has been drawn into the main volume 310 of the syringe 300. The main volume 310 is generally delimited by the piston 308 which is moveable using the plunger 302 of the syringe.
Although in Fig. 8C it is shown that all of the liquid in the intermediate volume 203 has been drawn into the single syringe 300, other possibilities are envisioned as well. For example, for any method and any device disclosed herein, the intermediate volume 203 may be filled with sufficient liquid to fill multiple syringes, for example two or more, five or more, or even ten or more syringes. As such, when the buffer member 200 is moved from the second rotational position back into the first rotational position, there may still be liquid inside the intermediate volume 203, which
Liquid can be drawn into a further syringe 300.
Fig. 9 schematically shows another example of a device 100 for filling a syringe. Any feature disclosed herein, for example but not necessarily in conjunction with Figs. 1-7, may be readily applied to this example of the device 100. Furthermore, any feature disclosed in conjunction with Fig. 9 may be readily applied to any other device 100 disclosed herein, for example but not necessarily in conjunction with Figs. 1-7.
The device 100 comprises a frame 104 and a buffer member 200 rotationally connected to the frame 104. By virtue of this rotational connection, the buffer member 200 can be rotated relative to the frame 104 between the first rotational position and second rotational position and optional third rotational position as discussed above. The buffer member 200 comprises the optional fluid inlet 204, the fluid outlet 202, and the syringe connector 206.
A particular option disclosed in conjunction with Fig. 9 but also applicable to any other device is that the device 100 may comprise a rotational actuator, here embodied as an electric motor 191. The electric motor 191 can be driven to rotate the buffer member 200 relative to the frame 104, for example about the rotation axis R.
Additionally or alternatively to the device 100 comprising the rotational actuator 191, as a particular option disclosed in conjunction with
Fig. 9 but also applicable to any other device is that the device 100 may comprise a plunger actuator 193. The plunger actuator 193 can be driven to move the plunger guide 120 relative to buffer member 200, for example in a translation direction 7. The plunger actuator 193 may comprise an electric motor, pneumatic actuator, hydraulic actuator, any linear actuator, or any combination thereof.
When a device 100 comprises a rotational actuator and/or a plunger actuator, the device 100 may further comprise a controller 190 for controlling the rotational actuator and/or plunger actuator. In particular, the controller 190 may be arranged to send a rotation control signal 192 to the rotational actuator and/or to send a translation control signal 194 to the plunger actuator.
For example based on a user input, the translation control signal 194 may be used to actuate the plunger actuator towards a particular distal position, corresponding to a particular volume of liquid being drawn into the syringe.
In the description above, it will be understood that when an element 1s referred to as being connect to another element, the element is either directly connected to the other element, or intervening elements may also be present. Also, it will be understood that the values given in the description above, are given by way of example and that other values may be possible and/or may be strived for.
It is to be noted that the figures are only schematic representations of embodiments that are given by way of non-limiting examples. For the purpose of clarity and a concise description, features are described herein as part of the same or separate embodiments, however, it will be appreciated that the scope of the disclosure may include embodiments having combinations of all or some of the features described.
The word ‘comprising’ does not exclude the presence of other features or steps. Furthermore, the words 'a’ and 'an' shall not be construed as limited to 'only one’, but instead are used to mean 'at least one’, and do not exclude a plurality.

Claims (21)

ConclusiesConclusions 1. Apparaat (100) voor vullen van een spuit (300), het apparaat omvattende: - een frame (104); en - een bufferdeel (200), omvattende: een bufferlichaam (201) welk een tussenvolume voor daarin ontvangen van een fluidum aanwijst, een fluiduminlaat (204) in fluidumverbinding met het tussenvolume, een fluidumuitlaat (202) in fluidumverbinding met het tussenvolume, en een spuitverbinder (206) voor verbinden van een spuit met het bufferdeel zodanig dat de spuit in fluidumverbinding is met de fluidumuitlaat; waarin het bufferdeel rotationeel verbonden is met het frame zodanig dat het bufferdeel geroteerd kan worden ten opzichte van het frame tussen een eerste rotationele positie waarin de fluidumuitlaat gepositioneerd kan worden boven een vloeistofniveau in het tussenvolume, en een tweede rotationele positie waarin de fluidumuitlaat onder het vloeistofniveau in het tussenvolume gepositioneerd kan worden.1. An apparatus (100) for filling a syringe (300), the apparatus comprising: - a frame (104); and - a buffer member (200), comprising: a buffer body (201) designating an intermediate volume for receiving a fluid therein, a fluid inlet (204) in fluid communication with the intermediate volume, a fluid outlet (202) in fluid communication with the intermediate volume, and a syringe connector (206) for connecting a syringe to the buffer member such that the syringe is in fluid communication with the fluid outlet; wherein the buffer member is rotationally connected to the frame such that the buffer member can be rotated relative to the frame between a first rotational position in which the fluid outlet can be positioned above a liquid level in the intermediate volume, and a second rotational position in which the fluid outlet can be positioned below the liquid level in the intermediate volume. 2. Apparaat volgens conclusie 1, waarin het bufferdeel deels gevuld is met vloeibaar medicijn.2. The apparatus of claim 1, wherein the buffer portion is partially filled with liquid medication. 3. Apparaat volgens conclusie 2, waarin het bufferdeel deels gevuld is met lucht.3. The apparatus of claim 2, wherein the buffer portion is partially filled with air. 4. Apparaat volgens een van de voorgaande conclusies, waarin in de tweede rotatiepositie de fluiduminlaat gepositioneerd is boven de spuitverbinder en/of de fluiduminlaat boven de fluïdumuitlaat gepositioneerd is.4. Apparatus according to any one of the preceding claims, wherein in the second rotational position the fluid inlet is positioned above the syringe connector and/or the fluid inlet is positioned above the fluid outlet. 5. Apparaat volgens een van de voorgaande conclusies, waarin het apparaat verder een ontvangst (108) omvat, welke ontvangst rotationeel verbonden is met het frame, en het bufferdeel ten minste deel in de ontvangst gepositioneerd is zodanig dat het bufferdeel rotationeel verbonden is met het frame via de ontvangst.5. Apparatus according to any preceding claim, wherein the apparatus further comprises a receiver (108), the receiver being rotationally connected to the frame, and the buffer member being at least partially positioned in the receiver such that the buffer member is rotationally connected to the frame via the receiver. 6. Apparaat volgens een van de voorgaande conclusies, waarin het bufferdeel rotationeel verbonden is met het frame zodanig dat het bufferdeel geroteerd kan worden tussen de eerste rotationele positie en de tweede rotationele positie ten opzichte van het frame rond een in hoofdzaak horizontale rotatie-as.6. Apparatus according to any preceding claim, wherein the buffer member is rotationally connected to the frame such that the buffer member can be rotated between the first rotational position and the second rotational position relative to the frame about a substantially horizontal rotational axis. 7. Apparaat volgens een van de voorgaande conclusies, verder omvattende een plunjergeleide (120) ingericht om op een plunjer van een spuit aan te grijpen, welke plunjergeleide beweegbaar verbonden is met het frame zodanig dat de plunjergeleide getransleerd kan worden tussen een proximale positie en een distale positie, waarin in de proximale positie, een afstand tussen de plunjergeleide en het bufferdeel kleiner is dan de afstand tussen de plunjergeleide en het bufferdeel in de distale positie van de plunjergeleide.7. The apparatus of any preceding claim, further comprising a plunger guide (120) adapted to engage a plunger of a syringe, the plunger guide being movably connected to the frame such that the plunger guide can be translated between a proximal position and a distal position, wherein in the proximal position, a distance between the plunger guide and the buffer member is less than the distance between the plunger guide and the buffer member in the distal position of the plunger guide. 8. Apparaat volgens conclusie 7, waarin het apparaat verder een stopdeel (124) omvat welke de distale positie van de plunjergeleide definieert.8. The apparatus of claim 7, wherein the apparatus further comprises a stop member (124) defining the distal position of the plunger guide. 9. Apparaat volgens conclusie 8, waarin het stopdeel losmaakbaar verbonden is met het frame zodanig dat een positie van het stopdeel ten opzichte van het bufferdeel kan worden aangepast.9. The apparatus of claim 8, wherein the stop member is detachably connected to the frame such that a position of the stop member relative to the buffer member can be adjusted. 10. Apparaat volgens een van de conclusies 7-9, verder omvattende een aandrukdeel voor in de proximale positie drukken van de plunjergeleide.10. Apparatus according to any of claims 7 to 9, further comprising a pressing member for pressing the plunger guide into the proximal position. 11. Apparaat volgens een van de conclusies 7-10, waarin het apparaat verder een plunjergeleide-actuator (193) omvat, voor bewegen van de plunjergeleide ten opzichte van het frame.11. The apparatus of any one of claims 7 to 10, wherein the apparatus further comprises a plunger guide actuator (193) for moving the plunger guide relative to the frame. 12. Apparaat volgens een van de voorgaande conclusies, verder omvattende een rotationele actuator, zoals een elektrische motor (191), voor roteren van het bufferdeel ten opzichte van het frame.12. Apparatus according to any preceding claim, further comprising a rotational actuator, such as an electric motor (191), for rotating the buffer member relative to the frame. 13. Samenstel (102) voor vullen een spuit, het samenstel omvattende: - een apparaat volgens een van de voorgaande conclusies; en - een spuit (200), welke spuit verbonden is of te verbinden is met de spuitverbinder van het bufferdeel.13. Assembly (102) for filling a syringe, the assembly comprising: - a device according to any one of the preceding claims; and - a syringe (200), which syringe is connected or can be connected to the syringe connector of the buffer part. 14. Samenstel volgens conclusie 13, waarin een grootte van het tussenvolume ongeveer overeenkomt met twee keer een grootte van een hoofdvolume van de spuit, bij voorkeur vijf keer of meer.14. The assembly of claim 13, wherein a size of the intermediate volume corresponds approximately to twice a size of a main volume of the syringe, preferably five times or more. 15. Samenstel volgens conclusie 13 of 14, waarin het tussenvolume van het bufferdeel gevuld is met een volume vloeibaar medicijn welke groter 1s dan de grootte van het hoofdvolume van de spuit.15. An assembly according to claim 13 or 14, wherein the intermediate volume of the buffer portion is filled with a volume of liquid medication which is greater than the size of the main volume of the syringe. 16. Werkwijze voor vullen van een spuit, omvattende stappen van: - verbinden van een spuit met een spuitverbinder van een bufferdeel, zodanig dat een hoofdvolume van de spuit in fluidumverbinding staat met een tussenvolume van het bufferdeel, welk tussenvolume ten minste deels is gevuld met een vloeistof (400); - roteren van de spuit en het bufferdeel van een eerste rotationele positie naar een tweede rotationele positie ten opzichte van een frame van een apparaat voor vullen van een spuit, aan welk frame het bufferdeel rotationeel verbonden is, zodanig dat een fluidumuitlaat van het bufferdeel onder een vloeistofniveau (402) van vloeistof in het bufferdeel gepositioneerd 1S; - trekken van een volume vloeistof van het tussenvolume het hoofdvolume van de spuit in door de fluidumuitlaat, zodanig dat het hoofdvolume in hoofdzaak vrij is van gassen zoals lucht; en - losmaken van de spuit van het bufferdeel.16. A method for filling a syringe, comprising the steps of: - connecting a syringe to a syringe connector of a buffer member such that a main volume of the syringe is in fluid communication with an intermediate volume of the buffer member, the intermediate volume being at least partially filled with a liquid (400); - rotating the syringe and the buffer member from a first rotational position to a second rotational position relative to a frame of an apparatus for filling a syringe to which frame the buffer member is rotationally connected such that a fluid outlet of the buffer member is positioned below a fluid level (402) of liquid in the buffer member; - drawing a volume of liquid from the intermediate volume into the main volume of the syringe through the fluid outlet such that the main volume is substantially free of gases such as air; and - detaching the syringe from the buffer member. 17. Werkwijze volgens conclusie 16, waarin in de eerste rotationele positie, de spuit in hoofdzaak horizontaal georiénteerd is.17. The method of claim 16, wherein in the first rotational position, the syringe is oriented substantially horizontally. 18. Werkwijze volgens een van de conclusies 16-17, waarin in de tweede rotationele positie, de spuit in hoofdzaak verticaal georiénteerd is.18. A method according to any one of claims 16 to 17, wherein in the second rotational position, the syringe is oriented substantially vertically. 19. Werkwijze volgens een van de conclusies 16-18, waarin de vloeistof een vloeibaar medicijn is.19. A method according to any one of claims 16 to 18, wherein the liquid is a liquid medicine. 20. Werkwijze volgens een van de conclusies 16-19, verder omvattende positioneren van ten minste deel van het bufferdeel in een ontvangst van het apparaat voor vullen van de spuit.20. A method according to any one of claims 16 to 19, further comprising positioning at least part of the buffer member in a receptacle of the apparatus for filling the syringe. 21. Werkwijze volgens een van de conclusies 16-20, verder omvattende toestaan van een stroom aan fluïdum, zoals lucht, het tussenvolume in tijdens trekken van het volume aan vloeistof van het tussenvolume het hoofdvolume van de spuit in.21. The method of any one of claims 16 to 20, further comprising allowing a flow of fluid, such as air, into the intermediate volume while drawing the volume of fluid from the intermediate volume into the main volume of the syringe.
NL2033713A 2022-12-12 2022-12-12 Method and device for filling syringes NL2033713B1 (en)

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Citations (1)

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Publication number Priority date Publication date Assignee Title
US6915823B2 (en) * 2002-12-03 2005-07-12 Forhealth Technologies, Inc. Automated apparatus and process for reconstitution and delivery of medication to an automated syringe preparation apparatus

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CN105307621B (en) * 2013-09-19 2020-01-10 株式会社汤山制作所 Mixed injection device and mixed injection method
NL2029329B1 (en) 2021-10-06 2023-04-17 Sjj Solutions B V Methods and device for filling one or more syringes

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6915823B2 (en) * 2002-12-03 2005-07-12 Forhealth Technologies, Inc. Automated apparatus and process for reconstitution and delivery of medication to an automated syringe preparation apparatus

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