EP4138959A1 - Medizinische spritze sowie kolbenstopfen für eine medizinische spritze - Google Patents
Medizinische spritze sowie kolbenstopfen für eine medizinische spritzeInfo
- Publication number
- EP4138959A1 EP4138959A1 EP21721470.9A EP21721470A EP4138959A1 EP 4138959 A1 EP4138959 A1 EP 4138959A1 EP 21721470 A EP21721470 A EP 21721470A EP 4138959 A1 EP4138959 A1 EP 4138959A1
- Authority
- EP
- European Patent Office
- Prior art keywords
- piston
- stopper
- syringe
- plunger
- web
- 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
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/28—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
- A61M5/31511—Piston or piston-rod constructions, e.g. connection of piston with piston-rod
- A61M5/31513—Piston constructions to improve sealing or sliding
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
- A61M5/31511—Piston or piston-rod constructions, e.g. connection of piston with piston-rod
- A61M5/31515—Connection of piston with piston rod
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2207/00—Methods of manufacture, assembly or production
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2207/00—Methods of manufacture, assembly or production
- A61M2207/10—Device therefor
Definitions
- the invention relates to a medical syringe and a plunger stopper for a medical syringe.
- the invention relates to a sterile packaged medical syringe which is prefilled with an active ingredient-containing solution or emulsion.
- Pre-filled medical syringes made of plastic are known.
- Such a syringe consists of a syringe body with a nozzle for dispensing the medical liquid and a piston with a piston rod.
- the plunger and the plunger rod usually do not consist of one piece, but a plunger stopper made of an elastic material is used, which is then connected to the plunger rod.
- the piston stopper can tilt, as a result of which the force required for a further advance is increased by leaps and bounds.
- the plunger stopper consists of two different materials.
- This document shows a piston main body which consists in particular of a cycloolefin copolymer and which has grooves into which two O-rings made of bromobutyl, which act as sealing rings, are pressed.
- the invention is based on the object of providing a plunger stopper or a syringe with a plunger stopper, which is or are further improved in terms of tightness, necessary feed force and / or possible interactions with the filled medical liquid.
- the object of the invention is already achieved by a plunger stopper according to one of the independent claims and by a medical syringe equipped with the plunger stopper and by a method for producing a medical syringe.
- the invention relates to a plunger stopper for a medical syringe, the plunger stopper having an end wall, a side wall and an internal thread for fastening a plunger rod, the plunger stopper comprising a main body which is a cycloolefin, in particular a cycloloefin copolymer, a cycloolefin Polymer and / or a crystal clear polymer, wherein a plurality of sealing rings made of an elastic material extend around the main piston body and are connected to the main piston body in a materially bonded manner.
- a cycloolefin in particular a cycloloefin copolymer, a cycloolefin Polymer and / or a crystal clear polymer
- a cycloolefin in the context of the invention is understood to mean all cycloolefin copolymers which are characterized by catalyzed copolymerization of cycloolefins can be obtained.
- cycloolefins are also understood to mean materials which are obtained by ring-opening salt metathesis. Strictly speaking, these are not referred to as cycloolefin copolymers, but rather as cycloolefin polymers.
- cycloolefin can also be designed as a crystal clear polymer.
- the main piston body is preferably at least 50 by weight, particularly preferably at least 90 by weight, made of a cycloolefin.
- Such materials are amorphous, transparent and, to a much lesser extent than other plastics, interact with the filled medical liquid, in particular with an aqueous medical liquid.
- the sealing rings are preferably not pretensioned.
- the elasticity and the cross section of the respective sealing ring can therefore be selected essentially completely independently of the main piston body.
- the main piston body is provided with at least two sealing rings.
- three or four sealing rings can also be provided.
- all sealing rings have the same cross section.
- the main piston body is encapsulated with the sealing rings. This has the advantage that a material connection can be provided in a simple manner, in particular without further additives.
- the sealing rings have, at least in sections, a rounded shape, in particular the shape of a segment of a circle.
- the sealing rings can have the shape of a semicircle.
- the cross section of a sealing ring is composed of a segment of a circle and a polygon, in particular a rectangular base.
- the polygonal base can thus be arranged in a corresponding groove in the main piston body, whereas the circular segment protrudes radially out of the main piston body and can be compressed when it is inserted into the syringe body.
- the distal first sealing ring is at least partially covered distally by a circumferential web of the main piston body.
- the web enlarges the end wall to form a cover which covers the distal front sealing ring.
- the web preferably adjoins the first sealing ring distally.
- the circumferential web forms the largest diameter of the main piston body, i.e. the diameter of the
- the main piston body is smaller behind the web, in particular over the entire length of the main piston body. At least a part of the sealing ring is covered by the circumferential web, whereby an interaction of the sealing ring material with the medical fluid is further reduced, since the web is formed from a cycloolefin.
- the web when the syringe is mounted, the web can rest against the inner wall of the main piston body in such a way that the piston stopper can still be moved or displaced in the syringe body.
- the outer diameter of the web essentially corresponds to an inner diameter of the syringe body or is somewhat smaller in one embodiment of the invention.
- the distally foremost sealing ring preferably protrudes beyond the web at the edge.
- the sealing ring protrudes 0.05 to 0.5 mm, preferably 0.08 to 0.2 mm, beyond the edge of the web.
- the web Because of the harder material of the main piston body, the web only acts as a seal to a limited extent. The tightness of the syringe is ensured by the following sealing rings.
- the distal first sealing ring preferably directly adjoins the web. This keeps the possible volume between the web and the sealing ring low. In particular, this is largely filled by the resilient sealing ring.
- the web preferably has a height of less than 1 mm, particularly preferably less than 0.5 mm.
- the web is designed as a circumferential rib.
- the circumferential web can furthermore be rounded at the edge in order to facilitate sliding along the side wall of the syringe body.
- the end wall of the piston stopper is conical in the distal direction both on the outside and on the inside.
- the distal outer cone preferably corresponds essentially to a cone of the syringe main body, so that it is ensured that the syringe can be almost completely emptied.
- a conical shape on the inside that is to say the proximal side of the end wall, can have advantages in guiding the piston stopper.
- a correspondingly conical piston rod can have a conical end, as a result of which the piston stopper is centered during the advance.
- the sealing rings consist of a butyl rubber, in particular a halobutyl rubber, such as, for example, a chlorobutyl and / or bromobutyl.
- a halobutyl rubber such as, for example, a chlorobutyl and / or bromobutyl.
- the sealing rings can, however, also consist of a different plastic.
- Silicones or polypropylenes are particularly suitable as further plastic materials.
- the internal thread is the
- Piston stopper designed as a two-way trapezoidal thread. Such a thread distributes the forces acting over a large area.
- the piston stopper can also have a coating.
- the sealing rings and / or the main piston body can be provided with a coating.
- This can be, for example, a coating made of a polytetrafluoroethylene, which can serve both as a migration barrier and as a lubricant layer.
- the ratio of a wall thickness of the side wall to the diameter of the piston stopper is more than 0.03, preferably more than 0.05, particularly preferably more than 0.06, and / or less than 0.2, preferably less than 0.1, particularly preferably less than 0.08. It has been found that this ratio enables particularly good guidance of the piston stopper to be achieved.
- the sealing rings have a height of more than 0.5 mm, preferably more than 1.0 mm, particularly preferably more than 2 mm, and / or less than 5 mm and / or preferably less than 3 mm.
- the height of the sealing ring is understood to mean the extension in the radial direction starting from a contact surface of the sealing ring with the main piston body.
- a part of the sealing ring can, as stated above, sit in a groove of the piston main body.
- the end wall is preferably designed in the shape of a truncated cone.
- the end wall can have a proximal point angle on the outside, which corresponds in particular to the distal point angle of the end wall, that is to say on the inside.
- the end wall is designed in the shape of a roof.
- the proximal and / or the distal tip angle can in particular be above 100 °, preferably above 120 °, particularly preferably above 140 °, and / or below 170 °, preferably below 160 °, particularly preferably below 155 °.
- the thread in particular the trapezoidal thread, is designed in one embodiment such that the ratio of a tooth height of the internal thread to a tooth diameter of the piston stopper is above 0.04, particularly preferably above 0.05, and / or below 0.15.
- the diameter of the piston stopper is between 15 mm and 30 mm.
- the wall thickness of the end wall is 1 to 2 times, preferably 1.2 to 1.6 times, the wall thickness of the side wall.
- the piston stopper is partly thickened on the side wall, since the teeth of the internal thread protrude from the inside of the side wall. Corresponding dimensioning of the front wall results in similar size relationships both on the front side and with regard to the side wall. This makes it easier to manufacture the piston stopper. In particular, this also reduces stresses in the material during injection molding, e.g. due to different cooling.
- the pitch of the internal thread is between 0.4 and 0.8 mm, preferably between 0.5 and 0.7 mm.
- the piston stopper can have an overall length, including the conical end wall, between 8 mm and 20 mm, preferably between 14 mm and 16 mm.
- the invention also relates to a syringe which is equipped with a plunger stopper as described above.
- the syringe body can be made of the same material as the plunger main body.
- the syringe body and the main piston body consist of a cycloolefin, in particular of the same cycloolefin. This reduces the number of different materials and therefore makes it easier to assess possible interactions with the medical fluid.
- the circumferential web can bear against the inner wall of the syringe body.
- the syringe comprises a plunger rod, in particular with a conically shaped distal end which, when the plunger rod is connected to the plunger stopper, rests on a preferably conically shaped inner side of the end wall of the plunger stopper.
- the piston When the piston is advanced, it is centered and therefore less prone to tilting.
- the syringe is designed in particular as a prefilled syringe which is filled, for example, with a medical liquid that contains a medicament.
- the medical liquid is an oxygen-sensitive drug fluid, for example a drug emulsion.
- the drug fluid is or comprises propofol, in particular a propofol emulsion.
- Propofol is described by the chemical name 2,6-diisopropylphenol (IUAPC).
- IUAPC 2,6-diisopropylphenol
- the syringe can comprise a connection piece, in particular a threaded connection.
- the syringe can comprise a male Luer lock connector with which the syringe can be connected, for example, to a transfer set for the application of the medical liquid.
- the syringe is preferably autoclaved and, in particular, is arranged in an outer packaging which is impermeable to oxygen, such as, for example, a film packaging.
- the invention relates to a syringe, in particular a syringe with one or more of the features described above.
- the syringe comprises a syringe body and a plunger stopper inserted into the syringe body, which plunger stopper comprises a main plunger body and at least one sealing ring, the sealing ring being at least partially covered distally by a circumferential web of the main plunger body, the web protruding radially from the main plunger body and the piston main body proximally behind the at least one sealing ring has a smaller outer diameter than the circumferential web.
- the circumferential web forms a distal cover which reduces the contact of the sealing ring with the medical fluid.
- the invention also relates to a method for
- Injection molding of a syringe body which is at least partially formed from a first material, injection molding of a piston main body from the first material, injection molding of at least one sealing ring onto the piston main body to form a piston stopper, inserting the piston stopper into the syringe body.
- the syringe body can be made from several different materials. However, at least the inner wall of the tip body is preferably formed from the first material.
- the first material is in particular a cycloolefin.
- the inner wall of the syringe body and the plunger are made of the same material, possible interactions with a medical liquid can be reduced.
- Fig. 1 is a sectional view of an embodiment of a syringe according to the invention.
- FIG. 2 is a side view of the plunger stopper used for the syringe.
- FIG. 3 is a sectional view taken along line AA of FIG.
- FIG. 4 is a sectional view of another embodiment of a piston plug.
- FIG. 5 shows the method steps according to an exemplary embodiment of the invention for producing a syringe.
- FIG. 1 shows a sectional view of a medical syringe 1 which is equipped with a plunger stopper 10 according to the invention.
- the syringe 1 is arranged here in an outer packaging 2 shown schematically.
- the outer packaging 2 is designed as a tear-open film packaging and the syringe 1 was autoclaved in particular in the outer packaging 2.
- the syringe 1 comprises a syringe body 3 which provides a volume that is prefilled with a medical liquid 4.
- the nozzle 5 of the syringe 1 is closed with a stopper 6.
- the internal volume of the syringe 1 can contain an oxygen-free or reducing gas, in particular nitrogen, in order to avoid deformation of the syringe body 3 in the event of pressure fluctuations.
- the syringe 1 comprises a plunger rod 7, preassembled here by way of example, with a proximal end of the handle, which is connected to the piston stopper 10 via its distal end.
- the piston rod 7 comprises an external thread 8 which is screwed into the internal thread 16 of the piston stopper 10.
- the distal end 9 of the piston rod 7 is conical, in this exemplary embodiment conical, and rests against the end wall 11 of the piston stopper 10, which is correspondingly configured on the inside.
- the piston rod 7 can also not be preassembled, for example provided lying next to the syringe body 3 in the outer packaging 2 (not shown here).
- FIG. 2 shows a side view of an exemplary embodiment of a piston stopper 10 according to the invention.
- the piston stopper 10 comprises a conical, in particular frustoconical, end wall 11 and an essentially circular-cylindrical side wall 12.
- the piston stopper 10 comprises a total of four sealing rings 13a to 13d, which protrude or protrude radially from the side wall 12.
- a distal first sealing ring 13a directly adjoins the end wall 11 in the axial direction.
- a proximal first sealing ring 13d forms the proximal end of the piston stopper 10.
- the piston stopper 10 is formed by a piston main body 10a and the molded-on sealing rings 13a to 13d.
- the piston main body 10a is made of one cycloolefin, whereas the sealing rings 13a to 13d are made of another More elastic material, such as a halogen butyl rubber, are formed.
- the sealing rings 13a to 13d sit in grooves 15 in the side wall 12 of the piston main body 10a.
- sealing rings 13a to 13d there is an intermediate area which in the sectional view runs straight, in particular is designed as a circular cylinder and which in each case forms a circumferential web 18.
- the sealing rings 13a to 13d have essentially the same cross section in their base area. This is formed from a segment of a circle, in particular a semicircular section, which merges into a polygonal, in particular essentially rectangular, base section which is seated in a groove 15 in each case.
- the inner radius r of the segment-shaped section is 0.8 to 1.2 mm in this exemplary embodiment.
- the sealing rings 13a to 13d have a total height h between 1.0 and 1.5 mm.
- the wall thickness a of the side wall 12 is determined from the distance between the inner wall and the circumferential web 18 between the sealing rings 13a to 13d. According to the definition, the wall thickness a is not reduced by the grooves 15. In this exemplary embodiment, the wall thickness a is between 1.3 and 1.8 mm.
- the teeth of the internal thread 16 designed as a two-course trapezoidal thread protrude from the inside of the side wall 12.
- the tooth height z between the tooth base 17 and the Tooth tip can in particular be 1.2 to 1.7 mm.
- the internal thread 16 extends here essentially over the entire length of the side wall 12.
- the end wall 11 is frustoconical and has a tip 14 with an apex angle of 140 to 160 °.
- the inside 19 of the end wall 11, that is to say the distal side, is correspondingly conical here, so that a uniform wall thickness b is formed.
- the wall thickness b of the end wall 11 in this embodiment is 1.2 to 1.6 times the wall thickness a of the side wall.
- the piston stopper 10 has a total length 1 of 14 to 16 mm. In this exemplary embodiment, the diameter d is between 18 and 20 mm.
- the plunger stopper shown here is designed for syringes 1 with a filling volume of about 20 ml.
- the piston main body 10a comprises a distally circumferential web 20 which is directly connected to the top of the end wall 11.
- the web 20 protrudes radially outward in the form of a plate and is oriented perpendicular to the central axis of the piston stopper 10.
- the length in the axial direction of the web 20 is less than 0.5 mm.
- the web 20 directly adjoins the distally foremost sealing ring 13a.
- the web 20 thus forms a cover which, in the inserted state, covers the sealing ring 13a.
- the sealing ring 13a protrudes between 0.08 and 0.15 mm beyond the outer edge of the web 20.
- the sealing rings 13a to 13d are compressed and the web 20 preferably rests directly on the inner wall of the syringe body 3 in such a way that the plunger stopper 10 can be displaced in the syringe body 3.
- the web 20 is rounded at the edge, in particular with an edge radius between 0.2 and 0.4 mm.
- Fig. 4 shows an embodiment of a plunger stopper 10, which is designed for larger syringes 1, preferably with an internal volume of 50 ml.
- the sealing rings 13a to 13d and the peripheral web 20 on the edge are designed according to FIG. 3.
- the diameter d of the piston stopper is between 25 and 28 mm.
- the side wall 12 and / or the end wall 11 are made thicker approximately in accordance with the diameter.
- the length 1 is essentially identical to the piston stopper 10 shown in FIG. 3.
- FIG. 5 shows in a flow chart the steps of a method according to the invention for producing a medical syringe 1 according to an exemplary embodiment of the invention.
- a syringe body 3 is injected by means of an injection molding process, which is formed at least in sections from a first material.
- the first material preferably forms at least the inner wall of the syringe body 3. It can in particular be a cycloolefin.
- a piston main body 10a is then injection-molded from the same material, in particular also from a cycloolefin.
- At least one sealing ring 13a-13d, preferably a plurality of sealing rings 13a-13d, is then injection-molded onto the main piston body 10a to form a piston stopper 10.
- the plunger stopper 10 can now be inserted into the syringe body 3.
- the syringe 1 is preferably filled beforehand in a closed manner with a stopper 6.
- the syringe 1 can then be inserted into an outer packaging 2.
- the syringe 1 is autoclaved in the outer packaging 2 and is now also provided as a sterile prefabricated syringe for longer
- the invention makes it possible to provide a syringe 1 suitable for pre-filled syringes with improved properties.
- piston plug 10 piston plug 10a piston main body 11 end wall 12 side wall
Landscapes
- Health & Medical Sciences (AREA)
- Vascular Medicine (AREA)
- Engineering & Computer Science (AREA)
- Anesthesiology (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Hematology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Infusion, Injection, And Reservoir Apparatuses (AREA)
Abstract
Description
Claims
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP20171391 | 2020-04-24 | ||
PCT/EP2021/060472 WO2021214195A1 (de) | 2020-04-24 | 2021-04-22 | Medizinische spritze sowie kolbenstopfen für eine medizinische spritze |
Publications (1)
Publication Number | Publication Date |
---|---|
EP4138959A1 true EP4138959A1 (de) | 2023-03-01 |
Family
ID=70740408
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EP21721470.9A Pending EP4138959A1 (de) | 2020-04-24 | 2021-04-22 | Medizinische spritze sowie kolbenstopfen für eine medizinische spritze |
Country Status (4)
Country | Link |
---|---|
US (1) | US20230087154A1 (de) |
EP (1) | EP4138959A1 (de) |
CN (1) | CN115515668A (de) |
WO (1) | WO2021214195A1 (de) |
Family Cites Families (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP6321635B2 (ja) | 2012-06-27 | 2018-05-09 | ベクトン ディキンソン フランス | 医療用注入装置 |
JP5960554B2 (ja) * | 2012-08-30 | 2016-08-02 | 住友ゴム工業株式会社 | 積層ガスケット |
US20180043102A1 (en) * | 2016-08-09 | 2018-02-15 | Becton, Dickinson And Company | O-Ring Plunger for a Prefilled Syringe and Method |
WO2018083221A1 (de) * | 2016-11-04 | 2018-05-11 | Datwyler Pharma Packaging International Nv | Im kunststoff-spritzverfahren hergestellter kolben für eine medizinische spritze und eine medizinische spritze |
US10058658B1 (en) * | 2017-05-26 | 2018-08-28 | Precision Polymer Products, Inc. | Film faced articles and methods of manufacturing the same |
-
2021
- 2021-04-22 CN CN202180030659.XA patent/CN115515668A/zh active Pending
- 2021-04-22 EP EP21721470.9A patent/EP4138959A1/de active Pending
- 2021-04-22 US US17/759,761 patent/US20230087154A1/en active Pending
- 2021-04-22 WO PCT/EP2021/060472 patent/WO2021214195A1/de unknown
Also Published As
Publication number | Publication date |
---|---|
CN115515668A (zh) | 2022-12-23 |
WO2021214195A1 (de) | 2021-10-28 |
US20230087154A1 (en) | 2023-03-23 |
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