EP4138958A1 - Seringue, corps de seringue et procédé de fabrication associé - Google Patents

Seringue, corps de seringue et procédé de fabrication associé

Info

Publication number
EP4138958A1
EP4138958A1 EP21719658.3A EP21719658A EP4138958A1 EP 4138958 A1 EP4138958 A1 EP 4138958A1 EP 21719658 A EP21719658 A EP 21719658A EP 4138958 A1 EP4138958 A1 EP 4138958A1
Authority
EP
European Patent Office
Prior art keywords
syringe
base body
end wall
front side
structuring
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
EP21719658.3A
Other languages
German (de)
English (en)
Inventor
Torsten Brandenburger
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.)
Fresenius Kabi Deutschland GmbH
Original Assignee
Fresenius Kabi Deutschland GmbH
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 Fresenius Kabi Deutschland GmbH filed Critical Fresenius Kabi Deutschland GmbH
Publication of EP4138958A1 publication Critical patent/EP4138958A1/fr
Pending legal-status Critical Current

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
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/34—Constructions for connecting the needle, e.g. to syringe nozzle or needle hub
    • A61M5/347—Constructions for connecting the needle, e.g. to syringe nozzle or needle hub rotatable, e.g. bayonet or screw
    • 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
    • A61M5/002—Packages specially adapted therefor, e.g. for syringes or needles, kits for diabetics
    • 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
    • A61M5/3129—Syringe barrels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/06—Ampoules or carpules
    • 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
    • A61M2005/3103—Leak prevention means for distal end of syringes, i.e. syringe end for mounting a needle
    • A61M2005/3106—Plugs for syringes without 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/02—General characteristics of the apparatus characterised by a particular materials
    • A61M2205/0238—General characteristics of the apparatus characterised by a particular materials the material being a coating or protective layer
    • 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 syringe prefilled with a medical liquid, comprising a syringe body with a Luer lock connection, and a method for producing the syringe body.
  • Prefilled syringes which are also referred to as disposable syringes, can comprise a syringe body made of plastic.
  • the syringe body has a nozzle on its end face to dispense the medical liquid it contains.
  • the nozzle is used, for example, to connect a needle or a tube of a transfer system.
  • Syringes with male Luer lock connectors are particularly widespread.
  • the standardized conical nozzle is surrounded by a sleeve with an internal thread.
  • a suitable plastic material should meet various requirements.
  • the plastic material should be suitable for as many different medical fluids as possible. In particular, diffusion of constituents of the medical liquid into the material and also leaching of material components by the medical liquid should be largely avoided, even during long storage.
  • a suitable plastic material should also be autoclavable.
  • Cycloolefin copolymers have established themselves as particularly suitable materials. On the one hand, these are easy to process using the injection molding process. On the other hand, they are characterized by high rigidity and high hardness with a relatively low density at the same time. Such materials are also amorphous and highly transparent. They also have low water absorption and low water vapor permeability.
  • Cycloolefin copolymers for example, have a relatively low elongation at break compared to polypropylene or polyethylene. This can lead, for example, to the Luer-Lock thread of the syringe being damaged if the connection of a transfer system is improperly tightened. Due to the brittleness of the material, the material cannot undergo any significant plastic deformation, so that such damage can occur quite abruptly. The user has almost no tactile feedback that he is tightening the connection too much.
  • connection piece made of a softer material is injection-molded onto the rest of the syringe base body.
  • the invention is based on the object of at least reducing the stated problems of the prior art.
  • a syringe made of plastic which is prefilled with a medical liquid and which comprises an inner wall made of a material with high chemical resistance and good barrier effect and which is at the same time provided with a stable threaded connection made of plastic.
  • the object of the invention is achieved by a syringe body, a syringe and a method for producing a syringe body according to one of the independent claims.
  • the invention relates to a syringe body for a syringe, comprising a syringe base body with a side wall, an end wall and a nozzle arranged on a front side of the end wall, the syringe base body at least partially comprising a cyclo-olefin as the first material, which at least one inner wall of the syringe base body, wherein a connection piece with a threaded connection is arranged with its rear side on the front side of the end wall of the syringe base body and the connection piece, in particular at least in sections, comprises a second material of a different material than the first material, wherein the syringe base body and the connector to form the syringe body are cohesively connected to one another, and wherein a structure on the front of the end wall of the syringe base body and a complementary structure on the back of the connector interlock.
  • the invention provides in particular that at least the inner wall, preferably the entire side wall, of the syringe base body comprises a cycloolefin.
  • the entire syringe body is provided by a cycloolefin.
  • the first material consists preferably of at least 50 weight, particularly preferably at least 90 weight, of a cycloolefin.
  • cycloolefin is understood to mean all cycloolefin copolymers which are obtained by catalyzed copolymerization of cycloolefins.
  • 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.
  • the cycloolefin can also be designed as a crystal clear polymer.
  • the syringe body is from the
  • the connecting piece which comprises the threaded connection, being made of a different material than the syringe base body.
  • connection piece with the threaded connection is designed in such a way that the second material at least partially covers the first material at least on the front side.
  • the end face of the syringe body is formed at least in sections with two layers.
  • the first and the second material comprise an interlocking structure.
  • Structuring is understood to mean a regular or irregular height profile of the first material with elevations or depressions.
  • the second material e.g. injected in the injection molding process, engages in the depressions.
  • the structuring can also be viewed through a profile with mountains and valleys, the valleys being filled in by the other material.
  • the surfaces made of the first and the second material adjoining one another at an interface within the two-layer region each comprise a surface relief with a profile structure which is filled by the other material in each case.
  • the coefficient of linear thermal expansion in the case of cycloolefin copolymers is generally below 60 ⁇ 10 6 ⁇ Kl 1 .
  • Polypropylenes have, for example, a significantly higher coefficient of thermal expansion, in particular of more than 150 ⁇ 10 6 ⁇ K 1 .
  • the material connection does not break, especially in the case of an autoclaving process due to different thermal expansion of the two materials.
  • the structuring also increases the size of the surface of an interface between the first and the second material.
  • This interface is preferably at least 20% larger than an unstructured configuration.
  • the structuring can provide a form fit between the first and the second material, in particular with respect to a torque between the components when a connector is connected to the threaded connection.
  • injection molding around the nozzle with the second material can preferably be dispensed with. This can preferably any contact between the medical liquid and the second material can be avoided when used as intended.
  • an injection molding tool can be used for the production of the syringe base body which comprises a negative profile in the form of the profile of the syringe base body.
  • the front side of the end wall of the syringe base body and the rear side of the connection piece are materially connected to one another.
  • connection piece is provided as a separate component which is mounted on the syringe base body.
  • the connection piece is connected to the syringe base body in particular by means of gluing and / or welding.
  • connection piece is injection-molded onto the syringe base body.
  • the elevations can be designed as regular and / or irregular elevations.
  • the depressions can also be designed as regular and / or irregular depressions.
  • the elevations and / or the depressions are designed as concentric rings. With such a profiling, the elevations and the depressions run in particular radially from the inside to the outside. This results in a uniform pattern in particular everywhere
  • the elevations or depressions can in particular have an essentially triangular cross section.
  • the profile is designed as a sawtooth profile.
  • other structures such as, for example, a wave shape, in particular a sinus shape, interlocking knobs, etc., are possible.
  • elements of the structuring of the first material are conical.
  • the elements of the structure e.g. the bars or knobs, taper towards the top. This makes it easier to provide the structuring of the second layer by molding on the second material. In particular, the tendency to form bubbles in the area adjoining the structural elements is reduced.
  • the structuring on the front side of the end wall of the syringe base body comprises at least one web and / or a groove which extends from the nozzle, at least in sections, in the direction of the side wall.
  • An anti-rotation device is thus provided, as it were.
  • the elements of the structuring can also be designed as knobs and / or wedges.
  • the structuring of the end wall of the syringe base body can have at least one, preferably a plurality, of radially extending webs and / or grooves.
  • the webs or grooves can have any cross-section. However, they are preferably designed with a sawtooth profile.
  • the web and the groove each form a form fit that acts as an anti-twist device.
  • the structure can have a fan-like and / or star-like configuration in plan view.
  • the bars of a fan are formed by radially extending webs and the covering is formed by the annularly extending profile between the webs. The fan extends around the threaded connection and takes up 360 ° of the end face.
  • the structuring can have between 3 and 16, preferably between 6 and 10, webs and / or grooves which extend radially and are distributed around the circumference.
  • the form fit provided by the structuring serves, in particular, to improve the strength of the connection in the event of a torque load, such as, for example, when the connection is screwed in strongly.
  • a layer made of the second material around the threaded connection is thickened compared to a radially adjoining region of the layer made of the second material.
  • the material of the second layer is thus reinforced by a thickening, such as a bead or an inner bevel. On the one hand, this reduces the risk of the threaded connection breaking off if it is tightened too much.
  • the second material is preferably a plastic, in particular a transparent plastic, which can be processed by injection molding.
  • the second material preferably has a higher notched impact strength than the first material.
  • the second material has at least 20%, preferably at least 50%, higher notched impact strength than the first material.
  • Notched impact strength is a material parameter that defines the tendency of the material to crack under dynamic loading. This is determined in the notched bar impact test. The dynamic bending caused by the sudden loading causes a break, often without the flow of the material observed during slow loading.
  • all material parameters, in particular the notched impact strength and the following material parameters are determined under standard conditions, ie 20 ° C. and 50% air humidity.
  • the notched impact strength within the meaning of the invention is determined in accordance with DIN ISO 179-1 (11/2010).
  • a test specimen with a standardized shape is loaded with a notch by a pendulum hammer. With a defined kinetic energy, the impact pendulum notches the test body or pierces it. The notch is then measured or, if it breaks through, the height to which the pendulum swings back is recorded.
  • the impact energy consumed can be calculated from the weight of the impact pendulum and the difference between the pendulum start and end position, with the impact work being the product of the specimen cross section and notched impact strength.
  • Cycloolefins generally have a notched impact strength of less than 3 kJ / m 2 .
  • the second material should have a higher notched impact strength, in particular of more than 3.5 kJ / m 2 , preferably of more than 5 kJ / m 2 .
  • Polypropylene in particular, can be used as the second material.
  • Partially crystalline polypropylene in particular has good mechanical properties and is transparent at the same time.
  • the second material can in particular be softer than the first material.
  • the second material can have a Shore D hardness (according to DIN ISO 7619-1 (2/2012) of less than 75, in particular less than 70.
  • the cycloolefin has a Shore D hardness of over 80 in one embodiment of the invention.
  • the second material has a smaller modulus of elasticity than the first material.
  • the modulus of elasticity of the second material (according to DIN ISO 527-1 (22019) is between 1000 and 1800
  • the modulus of elasticity of the cycloolefin can in particular be between 1800 and 2200 MPa.
  • the second material has at least 1.5 times, preferably at least 5 times, particularly preferably at least 10 times, higher elongation at break than the first material.
  • the elongation at break is also determined in accordance with DIN ISO 527-1. This is given in%.
  • the cycloolefin used can, for example, have an elongation at break of less than 5%, whereas, for example, a polypropylene used can have an elongation at break of 100% or more.
  • the material In order to break the thread connection, the material must be deformed beyond the upper yield point. A trained user usually notices the subsequent deformation in the plastic area of a material with high elongation at break, so that he recognizes that the load-bearing limit of the connection has actually already been exceeded.
  • the structuring on the front side of the end wall of the syringe base body is limited in particular by a radially circumferential web.
  • the structuring ends within the end wall of the tip body.
  • the web can in particular be formed by a front section of the side wall of the syringe base body. The highly transparent appearance of the side wall is completely retained.
  • the structuring ends when the inner side wall is reached.
  • the side wall extends as far as a front edge of the syringe body and the structuring ends directly on the side wall.
  • the entire front wall can be used to provide the structuring.
  • the material transition is practically invisible in the plan view, since it is located exactly on the inner edge of the side wall.
  • the structure of the first and / or the second material has a maximum structure depth of more than 0.1 mm, preferably of more than 0.25 mm, and / or of less than 1 mm, preferably less than 0.5 mm.
  • the structuring is therefore a structuring of the order of magnitude in the macro range, as a result of which the force deflection described above is effectively achieved.
  • the distance from elevation to elevation or depression to depression, the so-called structure width, in one embodiment of the invention is more than 0.2 mm, preferably more than 0.5 mm, and / or less than 3 mm, preferably less than 1.5 mm.
  • the ratio of maximum structure depth to structure width can be more than 0.1, preferably more than 0.25, and / or below 1, preferably below 0.5.
  • the wall thickness of the layer made of the first material is 0.3 to 3 times, preferably 0.5 to 1.5 times, the wall thickness of the layer made of the second material in the area of the end wall.
  • the total wall thickness, especially in the area of the at least partially two-layered end wall can, for example, be between 0.3 mm and 5 mm, preferably between 0.6 mm and 2.5 mm.
  • the scope of the invention also includes a syringe comprising a syringe body according to one of the embodiments described above, the syringe having a stopper with which the nozzle is closed, a plunger and also, in particular, a plunger stage for dispensing the medical liquid via the nozzle.
  • the piston rod can already be preassembled on the piston or provided separately.
  • the syringe according to the invention is preferably filled with a medical liquid, in particular with a those that contain a drug.
  • the syringe in this case is a pre-filled syringe.
  • the syringe is located in a preferably oxygen-impermeable overpack, for example a tearable film packaging.
  • the syringe preferably the packed syringe, is in particular autoclaved.
  • the syringe was autoclaved in this overpack, for example at a temperature of over 110 ° C., preferably over 120 ° C., and is thus completely sterile.
  • 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).
  • the invention can relate to a syringe comprising a syringe body with a nozzle and a threaded connection, the syringe body comprising a side wall and an end wall, the syringe body at least in sections being a cycloolefin, in particular a cycloolefin copolymer or a cycloolefin polymer, first Comprises material that forms an inner wall of the syringe body, and wherein the threaded connection at least partially comprises a second material other than the cycloolefin, wherein the first and the second material are cohesively connected to each other, and wherein the second material is at least in the area of the end wall extends in sections over the first material, so that the end wall is at least sectionally formed in two layers, the nozzle being formed from the first material and at least in sections being formed in one layer.
  • a syringe comprising a syringe body with a nozzle and a threade
  • the syringe can have any of the features described above in any combination.
  • the two-layer area of the end wall can be formed by a syringe base body with a structure, an interlocking structure being provided by a complementary structure of a connector. Because the nozzle is not enveloped by the second material, at least in sections, any contact of the second material with the medical liquid is avoided when used as intended. It has been found that a sufficient mechanical connection between the first and second material can nevertheless be achieved, in particular by means of an injection molding process. This can be ensured in particular by the structuring described above.
  • the invention also relates to a method for producing a syringe body.
  • the process consists of the following steps:
  • an injection molding tool is used here which comprises the negative of a structuring of the end wall of the syringe base body, so that a syringe base body with a structured end wall is produced.
  • connection piece with the threaded connection made of the second material is then injection-molded onto the end wall.
  • the connection piece forms a complementary structure which, as stated above, considerably improves the mechanical connection of the two materials.
  • Fig. 1 is an axial sectional view of a syringe according to a first embodiment of the invention.
  • Fig. 2 shows an alternative embodiment of a syringe.
  • Figure 3 is a perspective view of the head of the syringe or body.
  • FIG. 4 is a perspective view of the head piece of the syringe base body or of the syringe body without an attached connection piece.
  • FIG. 5 is a perspective view with the connector shown as a transparent grid.
  • FIG. 6 is a sectional view taken along line B of FIG.
  • FIG. 7 is a sectional view taken along the line C in FIG.
  • FIGS. 8 and 9 are schematic views of alternative structures.
  • FIG. 10 is a flow chart of the method steps according to an embodiment of the method according to the invention.
  • Fig. 1 shows in an axial sectional view an embodiment of a syringe 1 according to the invention, only the syringe body 2, but not the piston and piston rod, being shown in this view.
  • the invention is intended for syringes with almost any volume, in particular from 1 ml to 100 ml.
  • the syringe 1 comprises a nozzle 101, which is preferably conical.
  • a threaded connection 201 with an internal thread extends around the nozzle 101.
  • it is a male Luer lock connector.
  • the side wall of the syringe base body is also formed in two layers and covered with the second material.
  • the syringe body 2 comprises a syringe base body 100 which comprises the nozzle 101 and a connection piece 200 which comprises the threaded connection 201.
  • the side wall 102 of the syringe main body 100 is formed by a first material.
  • the first material is provided by cycloolefin.
  • the second material is also transparent.
  • FIG. 2 is an axial sectional view of an alternative embodiment of a syringe 1.
  • This embodiment is a relatively small syringe, in particular with an internal volume 3 of about 5 ml.
  • the basic structure of the syringe body 2 remains unchanged.
  • the dimensions of the connection, consisting of nozzle 101 and threaded connection 201, do not differ from the exemplary embodiment according to FIG. 2.
  • threaded connection 201 has a significantly larger diameter in relation to the maximum diameter of syringe body 2.
  • FIG 3 shows, in a perspective view, the head piece of a syringe 1 according to a further exemplary embodiment of the invention.
  • the syringe body 2 is formed from the syringe base body 100 and the connection piece 200, which is preferably molded onto the syringe base body 100.
  • the connection piece 200 is formed from a different material than the syringe base body 100.
  • the connection piece 200 is formed by a second material. The said second material is a different material than the first material, e.g. polypropylene.
  • connection piece 200 comprises an end wall 202 which extends as far as the side wall 102 of the syringe base body 100.
  • the threaded connection 201 with an internal thread extends around the nozzle 101, which is part of the syringe base body 100 and which is consequently also formed from the first material, namely from a cycloolefin.
  • the end wall 103 of the syringe main body 100 comprises a structure 104, which is preferably provided by the injection molding.
  • the structuring 104 of the end wall 103 comprises a multiplicity of rings 105a-105n which extend concentrically around the nozzle 101 and which are designed here as elevations.
  • These rings 105a-105n are interrupted by a multiplicity of radially extending grooves 106 which, in cooperation with the injection-molded connection piece 200, form an anti-twist device.
  • FIG. 5 is a perspective view, now illustrating the connector 200 as a transparent grid representation.
  • the two-layer area of the end wall of the syringe body 2 is shown, which is formed from the cycloolefin of the syringe base body 100 and a layer of the connecting piece 200 arranged above it made of the second material, in particular polypropylene.
  • the interlocking structure which is formed by the structure 104 of the first material, into which the structure 208 of the second material engages.
  • the interlocking structuring formed according to the invention is thus formed, as shown in particular in the detailed illustration according to FIG. 6 along section line B according to FIG.
  • the structuring 104 of the syringe main body 100 comprises a plurality of teeth 105a-105n in a radial sectional view.
  • the structuring 104 is designed as a type of sawtooth profile in an axial section.
  • teeth of the second material of the connection piece 200 engage between the teeth 105a-105n.
  • the second material extends as far as the edge 109 of the syringe body 2, so that the entire side wall 102 of the syringe base body 2 is formed from the cycloolefin.
  • the structuring both of the syringe main body 100 and of the connector 104/208, is designed as a regular structuring in this exemplary embodiment, in which the distance from mountain to mountain or valley to valley is defined by the distance a between two peaks or two valleys.
  • the mountains and valleys mentioned are also referred to as elevations or depressions.
  • the structuring 104/208 also has a maximum depth t, which is defined by the vertical distance between the tip of an elevation and the base of a depression.
  • the threaded connection 201 with the teeth 203 of the internal thread merges into the end wall 202 of the connection piece 200 via a bead 205 in the region of the second material. This increases the mechanical strength in this area, so that the risk of the threaded connection 201 breaking off is reduced.
  • the base 207 of the threaded connection 203 extends as far as an inner corner 107, at which the end wall 103 of the syringe base body 100 merges into the nozzle 101.
  • the nozzle 101 is therefore not enveloped by the second material.
  • the material of the connection piece 200 does not come into contact with the medical fluid when used as intended.
  • FIG. 7 is a sectional view along the line C of FIG. 5.
  • the section now runs through a radial groove 106 of the syringe base body 100.
  • the groove 106 is formed by the teeth or rings 105a -105m in a radially extending strip the structuring 104 are interrupted.
  • a corresponding web 209 made of the second material has formed in the groove 106. This forms an anti-twist device in cooperation with the groove 106.
  • a ring 105n reaching directly to the threaded connection 201 is not cut out by the groove 106. This also forms a deflection point in the region of the web 209, via which the introduction of stresses into the region of the web 209 is reduced. Furthermore, the syringe base body 100 is provided with a bead 108 on the edge side. The upper side 206 of the connection piece 200 or the end wall 4 of the syringe base body 2 is aligned with the upper edge 109 of the side wall 102.
  • FIGS. 8 and 9 show, in a schematic top view of the end wall 4 of the syringe body 2, alternative embodiments of a structuring.
  • the syringe base body 100 comprises a structure 104 which is formed from a multiplicity of protruding knobs that are regularly distributed in the two-layer area.
  • This structuring 104 is filled with the second material of the connection piece 200 and thus forms a form fit between the syringe base body 100 and the connection piece 200.
  • a complementary design with indentations is also possible. In this case, the knobs would be formed by the second material of the connection piece 200.
  • the structuring 104 comprises triangles directed radially with the tip towards the center point as elevations or depressions.
  • FIG. 10 is a flow diagram with the method steps according to an exemplary embodiment of the method according to the invention.
  • a syringe base body 100 is injected with a nozzle 101 made of a cycloolefin.
  • an injection molding tool is used which is designed in such a way that an end wall 103 of the syringe base body 100 comprises a structure 104.
  • connection piece 200 with a threaded connection 201 is then made from a second material, in particular made of a polypropylene, injection-molded onto the syringe base body 100.
  • the syringe body 2 which now consists of two different materials, is distinguished by the high strength of the connection, the entire inner wall of the syringe base body 2 being formed from the cycloolefin.

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  • 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)
  • Diabetes (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

La présente invention concerne une seringue, comprenant un corps de seringue doté d'une buse et un raccord fileté. Le corps de seringue comprend une paroi latérale et une paroi avant, le corps de seringue comprenant une cyclooléfine en tant que premier matériau, au moins en partie. Le premier matériau forme une paroi interne du corps de seringue. Le raccord fileté comprend, au moins dans des parties, en tant que deuxième matériau, un matériau autre que la cyclooléfine, les premier et deuxième matériaux étant liés d'un seul tenant l'un à l'autre. Le deuxième matériau s'étend dans la région de la paroi avant, au moins dans des parties, sur le premier matériau, de sorte que la paroi avant comprend, au moins dans des parties, une région à deux couches. Les premier et deuxième matériaux dans la région à deux couches comportent une structure de mise en prise mutuelle.
EP21719658.3A 2020-04-24 2021-04-22 Seringue, corps de seringue et procédé de fabrication associé Pending EP4138958A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP20171399 2020-04-24
PCT/EP2021/060469 WO2021214193A1 (fr) 2020-04-24 2021-04-22 Seringue, corps de seringue et procédé de fabrication associé

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EP4138958A1 true EP4138958A1 (fr) 2023-03-01

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EP21719658.3A Pending EP4138958A1 (fr) 2020-04-24 2021-04-22 Seringue, corps de seringue et procédé de fabrication associé

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US (1) US20230040207A1 (fr)
EP (1) EP4138958A1 (fr)
CN (1) CN115443165A (fr)
WO (1) WO2021214193A1 (fr)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2023209520A1 (fr) * 2022-04-26 2023-11-02 Pfizer Inc. Seringue multicouche dotée d'une partie de liaison filetée et son procédé de fabrication

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP3306796B2 (ja) * 1995-01-26 2002-07-24 大成化工株式会社 薬液が予備充填された注入筒向けガラスカートリッジ
US9408971B2 (en) * 2008-03-31 2016-08-09 Covidien Lp Self-capping syringe assembly with one-way valve
WO2009123150A1 (fr) * 2008-04-01 2009-10-08 生化学工業株式会社 Capsule de scellement étanche pour une partie expulsion de médicament liquide
DE102017200007A1 (de) 2017-01-02 2018-07-05 Schott Ag Spritze mit unterschiedlichen Materialien
DE102017112823A1 (de) 2017-06-12 2018-12-13 Schott Schweiz Ag Spritze mit Luer-Lock-Anschluss
DE202018105835U1 (de) * 2018-10-11 2018-11-09 Schott Schweiz Ag Spritzenkörper

Also Published As

Publication number Publication date
US20230040207A1 (en) 2023-02-09
CN115443165A (zh) 2022-12-06
WO2021214193A1 (fr) 2021-10-28

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