US20180207324A1 - Syringe including different materials - Google Patents

Syringe including different materials Download PDF

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Publication number
US20180207324A1
US20180207324A1 US15/860,285 US201815860285A US2018207324A1 US 20180207324 A1 US20180207324 A1 US 20180207324A1 US 201815860285 A US201815860285 A US 201815860285A US 2018207324 A1 US2018207324 A1 US 2018207324A1
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US
United States
Prior art keywords
syringe
connection
syringe body
module
cycloolefin
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.)
Abandoned
Application number
US15/860,285
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English (en)
Inventor
Judith Auerbach
Bastian FISCHER
Helena Derksen
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.)
Schott Pharma AG and Co KGaA
Original Assignee
Schott AG
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 Schott AG filed Critical Schott AG
Assigned to SCHOTT AG reassignment SCHOTT AG ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: AUERBACH, JUDITH, DERKSEN, Helena, FISCHER, BASTIAN
Publication of US20180207324A1 publication Critical patent/US20180207324A1/en
Priority to US17/954,750 priority Critical patent/US20230019725A1/en
Assigned to SCHOTT PHARMA AG & CO. KGAA reassignment SCHOTT PHARMA AG & CO. KGAA ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: SCHOTT AG
Abandoned legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/04—Macromolecular materials
    • A61L31/048—Macromolecular materials obtained by reactions only involving carbon-to-carbon unsaturated bonds
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/04—Macromolecular materials
    • A61L31/06—Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
    • 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
    • A61M5/3134—Syringe barrels characterised by constructional features of the distal end, i.e. end closest to the tip of the needle cannula
    • 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
    • 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
    • A61M5/344—Constructions for connecting the needle, e.g. to syringe nozzle or needle hub using additional parts, e.g. clamping rings or collets
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    • A61M5/344—Constructions for connecting the needle, e.g. to syringe nozzle or needle hub using additional parts, e.g. clamping rings or collets
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    • A61M5/346—Constructions for connecting the needle, e.g. to syringe nozzle or needle hub friction fit
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    • 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
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    • B29C45/00—Injection moulding, i.e. forcing the required volume of moulding material through a nozzle into a closed mould; Apparatus therefor
    • B29C45/0001—Injection moulding, i.e. forcing the required volume of moulding material through a nozzle into a closed mould; Apparatus therefor characterised by the choice of material
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C45/00—Injection moulding, i.e. forcing the required volume of moulding material through a nozzle into a closed mould; Apparatus therefor
    • B29C45/16—Making multilayered or multicoloured articles
    • B29C45/164—The moulding materials being injected simultaneously
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C45/00—Injection moulding, i.e. forcing the required volume of moulding material through a nozzle into a closed mould; Apparatus therefor
    • B29C45/16—Making multilayered or multicoloured articles
    • B29C45/1676—Making multilayered or multicoloured articles using a soft material and a rigid material, e.g. making articles with a sealing part
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C65/00—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor
    • B29C65/02—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure
    • B29C65/08—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure using ultrasonic vibrations
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C65/00—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor
    • B29C65/56—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor using mechanical means or mechanical connections, e.g. form-fits
    • B29C65/565—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor using mechanical means or mechanical connections, e.g. form-fits involving interference fits, e.g. force-fits or press-fits
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00—General aspects of processes or apparatus for joining preformed parts
    • B29C66/70—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material
    • B29C66/71—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material characterised by the composition of the plastics material of the parts to be joined
    • B29C66/712—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material characterised by the composition of the plastics material of the parts to be joined the composition of one of the parts to be joined being different from the composition of the other part
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
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    • B29C66/00—General aspects of processes or apparatus for joining preformed parts
    • B29C66/70—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material
    • B29C66/72—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material characterised by the structure of the material of the parts to be joined
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
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    • B29C66/00—General aspects of processes or apparatus for joining preformed parts
    • B29C66/70—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material
    • B29C66/73—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material characterised by the intensive physical properties of the material of the parts to be joined, by the optical properties of the material of the parts to be joined, by the extensive physical properties of the parts to be joined, by the state of the material of the parts to be joined or by the material of the parts to be joined being a thermoplastic or a thermoset
    • B29C66/731—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material characterised by the intensive physical properties of the material of the parts to be joined, by the optical properties of the material of the parts to be joined, by the extensive physical properties of the parts to be joined, by the state of the material of the parts to be joined or by the material of the parts to be joined being a thermoplastic or a thermoset characterised by the intensive physical properties of the material of the parts to be joined
    • B29C66/7315—Mechanical properties
    • B29C66/73151—Hardness
    • B29C66/73152—Hardness of different hardness, i.e. the hardness of one of the parts to be joined being different from the hardness of the other part
    • 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
    • A—HUMAN NECESSITIES
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    • A61M2207/00—Methods of manufacture, assembly or production
    • B—PERFORMING OPERATIONS; TRANSPORTING
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    • B29K2023/00—Use of polyalkenes or derivatives thereof as moulding material
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Definitions

  • the invention relates to syringes, and in particular, syringes having a syringe body, a syringe cone including a distal opening, and a connection arranged in the region of the syringe cone.
  • Syringes have become known from a multitude of patents that have a connection for various connectors that are mounted manually onto the tip of the syringe.
  • a syringe of this type is described, for example in US 2013/079 276 A.
  • a syringe body has become known from US 2013/079 276 A wherein a transport cap, an intravenous port or an injection needle can be screwed into a thread above the syringe cone. If, for example a transport cap is screwed into the thread, the syringe cone can be protected.
  • a syringe with a thread in the region of the Luer-Lock connection has become known from DE 202 158 07 U1, wherein the thread is part of the syringe body.
  • the Luer-Lock connection according to DE 202 158 07 U1 has an internal thread in the region of the syringe cone.
  • DE 692 26 166 T2 also describes a plastic syringe, wherein the needle connecting piece is in the embodiment of a standard Luer-Lock connection with a Luer cone and an outside wall with a screw thread about its inside circumferential wall.
  • EP 1 080 742 A1 or EP 1 410 819 A1 the thread that serves as the connection for connectors, is a part of the Luer cone. Similar systems wherein parts of the Luer cone are provided with an inside thread providing the connection for connectors, or respectively syringe needles, etc. are described in EP 1 923 086 A1 and EP 3 042 689 A1.
  • a syringe has become known, with a syringe cylinder and a needle attachment piece that is provided at a distal end of the syringe cylinder, wherein the syringe features a closure that includes a closure cap that closes the needle attachment piece in a sealing manner, and a safety cap, wherein the safety cap surrounds the closure cap and is secured via a retaining ring on the needle attachment piece.
  • the syringe is characterized in that at least the safety cap and the closure cap are a single component.
  • the retaining ring, as well as the closure cap and the safety ring can be manufactured from a thermoplastic elastomer (TPE) or polypropylene.
  • the needle attachment piece preferably includes glass, or consists of glass.
  • An embodiment of the needle attachment piece and the syringe that consists of hard plastic material including cycloolefin-copolymer (COC) or cycloolefin-polymer (COP) is not described in WO 2012/116 790 A1.
  • U.S. Pat. No. 8,038,182 B1 and EP 0 838 229 A2 also describe syringe bodies consisting of COC.
  • U.S. Pat. No. 8,038,182 B1 suggests an expensive design of the connection that is introduced into the thread of the Luer-Lock, wherein upward and downward directed forces in the connecting thread result in that the connection expands into a free space, and radial forces acting upon the syringe body that could lead to a break, are avoided.
  • a break is avoided through the use of a retaining element.
  • the connecting piece for example the thread of the Luer-Lock was of the same material as the syringe itself. This resulted in that, due to mechanical stresses between the connection or respectively the thread and the mating thread that is allocated to the connector, cracks occurred in the material of the syringe body, thereby compromising the functionality of the syringe. In the worst-case scenario such mechanical stresses can result in damage of the syringe itself or in leakage of same.
  • the material of the syringe body was for example COC (cycloolefin-copolymer) or COP (cycloolefin-polymer) and the connectors consisted of another material such as PC (polycarbonate), PVC (polyvinyl chloride), PE (polyethylene) or PA (polyamide).
  • COC cycloolefin-copolymer
  • COP cycloolefin-polymer
  • the connectors consisted of another material such as PC (polycarbonate), PVC (polyvinyl chloride), PE (polyethylene) or PA (polyamide).
  • the entire syringe body consists of a softer plastic material
  • PP polypropylene
  • connectors that, for example are to be screwed into the thread of the Luer-Lock include a multitude of different materials such as PC, PVC, polyethylene (PE) that will connect with the material of the Luer-Lock thread.
  • PC polyethylene
  • PE polyethylene
  • An additional problem of the current connectors is that they are generally screwed manually into the thread and that the insertion torque can fluctuate over a wide range, for example 12 Ncm to 56 Ncm, preferably 12 Ncm to 80 Ncm.
  • a syringe having a syringe body with a syringe cone that comprises a distal opening and a connection that is arranged in the region of the syringe cone, the materials of connection and syringe body are different.
  • the syringe body consists of a first material and the connection, in particular the thread consists at least in sections of a second material.
  • the second material is a softer material than the first material.
  • the second material can for example be a thermoplastic elastomer (TPE), an elastomer or polypropylene (PP), polycarbonate (PC), polyethylene (PE), polyamide (PA) or COC-E, that is characterized in that it has a higher impact strength and/or a lower E-module.
  • TPE thermoplastic elastomer
  • PP polypropylene
  • PC polycarbonate
  • PE polyethylene
  • PA polyamide
  • COC-E COC-E
  • a soft material is understood to be a material whose E-module is by 10 to 60% lower than that of the hard material.
  • the E-module of the first hard material is preferably in the range of greater than 2500 to 3500 MPa, preferably 2700 to 3200 MPa and that of the softer second material in the range of 1200 to 2500 MPa, preferably 1500 to 1800 MPa.
  • the second material is moreover characterized by a high impact strength of greater than 2 kJm 2 .
  • Impact strength is understood to be a measure for the resistance of a material relative to a sudden dynamic stress. The measure is the performed impact strength relative to the fractured surface, expressed in Joule per surface area [J/cm 2 ].
  • Soft materials generally have a high impact strength, whereas in contrast hard materials are materials with low impact strength.
  • Brittle materials such as COC have an impact strength of less than 2 kJ/m 2 .
  • a softer material is used than for the syringe body itself, it is possible that the softer material absorbs stresses and load peaks that can occur when screwing a connector or adaptor into the thread and that these are then not transferred to the syringe body.
  • a soft plastic material it is possible to compensate for various stress situations, for example load peaks, torques, etc.
  • the geometry of the connection is preferably the same as that of the Luer-Lock adapter (LLA). This ensures that a standard syringe is provided that can interact with diverse connecting elements, in particular with connectors and adaptors.
  • the softer material in the region of the connection, in particular the thread can however not prevent the occurrence of mechanical stresses.
  • the softer material does however provide a buffer to absorb load peaks, for example when screwing in the connector and to distribute these evenly across the syringe body.
  • the softer material thus represents a kind of buffer. It is possible that the soft material represents the thread geometry, as well as being introduced as a buffer between the thread of the connector and the thread of the syringe body that serves as the connection.
  • the first, hard material of the syringe body is preferably a COC (cycloolefin-copolymer) or COP (cycloolefin-polymer).
  • COC cycloolefin-copolymer
  • COP cycloolefin-polymer
  • the inventors have found that when using COC and COP as materials for the syringe body, the problem of crack formation can be prevented if the connection for the connectors or the Luer-Lock is manufactured from a softer material than the syringe body. By using a softer material, it becomes possible that even with high insertion torques, stresses at the thread or the connector and thus breaks, due to these stresses in the syringe, can be avoided.
  • thermoplastic elastomer especially a thermoplastic elastomer (TPE) or COC-E is preferably used as a softer second material.
  • TPE thermoplastic elastomer
  • Other possible polymers are polypropylene (PP), polyethylene (PE), polycarbonate (PC), polyamide (PA).
  • the first, as well as also the second material of the syringe body or the connection includes materials which can be sterilized at temperatures>100° C., especially 121° C., in particular at a maximum of 180° C.
  • materials for the syringe body are COC or COP and for the connector COC-E, TPE, PP, PE, PC or PA.
  • the syringe body represents a first component of the syringe and the connection, in particular the thread and possibly also the cone represent a second component.
  • First and second component are separate components which must be connected with each other, for example by means of welding.
  • the connection of first and second component can however also occur in a different manner.
  • a mechanical and/or a coalesced and/or a friction type and/or a form fitting connection would be conceivable.
  • connection between syringe body and connection is arranged such, that the first component is indeed connected with the second component, that however this connection can be detached at a predetermined force, in other words if the first component is definably detachably connected with the second component.
  • a visible break is initiated in an overload situation at a defined location instead of at a critical location, for example at a sealing point that is not visible.
  • a first method is characterized in that the syringe body consists of a first material and the connection, especially the thread consists of a second material, wherein the second material is softer than the first material, and first and second materials are provided separately.
  • the connection and the syringe body are connected with each other through material fit and/or friction fit and/or form fit and/or coalesced fit.
  • a coalesced fit it is especially preferred when the syringe body and connection are connected with each other through welding, in particular ultrasonic welding.
  • an injection molded part is obtained that consists of two or more different plastics.
  • An injection molding machine for multicomponent injection molding includes two or more injection units, but only one clamping unit.
  • a pre-molded part can be inserted into a tool for over-molding.
  • the softer material has an increased coefficient of friction that ensures that the thread cannot be over-tightened.
  • the attachment surface should be designed such that an as large as possible surface contact of the two materials ensures the stability of the connection.
  • FIGS. 1 a -1 c is a first version of a mechanical attachment of the connector on the syringe body
  • FIGS. 2 a -2 c is a second version of a mechanical attachment of the connector on the syringe body
  • FIGS. 3 a 1 - 3 c is a version with syringe body and connector as individual parts, wherein the individual parts are connected with one another by means of ultrasonic welding;
  • FIGS. 4 a -4 b is a first embodiment of a connector and syringe body created by means of multicomponent injection molding.
  • FIGS. 5 a -5 d is a second embodiment of a connector and syringe body created by means of multicomponent injection molding.
  • a syringe body 1 which generally includes a syringe cone 3 , with a distal opening 5 . Of entire syringe body 1 , only the upper part of the syringe in the region of syringe cone 3 is shown.
  • Syringe body 1 preferably consists of a hard plastic, for example a cycloolefin-copolymer (COC) or cycloolefin-polymer (COP).
  • a connector 10 for connectors or respectively attachment of syringes is arranged about syringe cone 3 . Connection 10 in this example is an attachment with an inside thread 12 , without being limited to same.
  • Connection 10 in this example is an independent part vis-à-vis syringe body 3 .
  • the syringe body as the first component and the connector as the second component are only mechanically connected with one another.
  • connection 10 is placed onto the syringe body and is locked in place in an undercut 14 , in other words, the connector is held in a form-fit.
  • Separate component 10 can either be screwed into or pressed onto undercut 14 .
  • over-molding may be provided in the region of the connection, for example with a plastic. Over molding stabilizes the connection of component 10 on the syringe body.
  • the material of connection 10 is softer than the material of the syringe body.
  • the E-module of the syringe body consisting of a hard material is preferably 2500-3500 MPa, the E-module of the connection consisting of a soft material 1200-2500 MPa.
  • the module of the softer material of connection 10 is generally 10 to 60% lower than the E-module of the hard material of the syringe body.
  • the soft material of the connection is a thermoplastic elastomer (TPE) or an elastomer or polypropylene (PP) or polyethylene (PE).
  • TPE thermoplastic elastomer
  • PP polypropylene
  • PE polyethylene
  • a notched impact strength of more than 2 kJ/m 2 characterizes the specified soft materials.
  • FIG. 1 c is a top view of syringe body 1 . Same components as in FIG. 1 a -1 b are identified with same reference numbers.
  • Hard materials such as cycloolefin-copolymer (COC) or cycloolefin-polymer (COP) have a low notched impact strength of less than 2 kJ/m 2 .
  • FIGS. 2 a -2 c illustrate an alternative embodiment of a mechanical union of a connection 100 on a syringe body 101 .
  • FIG. 2 a depicts connecting piece 100 with inside thread 112 .
  • Connecting piece 100 consists of a softer material, for example a thermoplastic elastomer, an elastomer, polycarbonate, polypropylene or polyethylene, compared with the hard material of the syringe body which may consist of COC or COP.
  • Connecting piece 100 is characterized in that, in addition to inside thread 112 , it features a circumferential attachment 114 with a hollow space 116 , wherein protrusions or elevations 110 of syringe body 101 can engage in hollow space 116 .
  • FIG. 2 a The detailed design of connecting piece 100 of the syringe body is shown in FIG. 2 a .
  • syringe body 101 consists of a hard material, for example COC and comprises a syringe cone 103 with a distal opening 105 .
  • syringe body 101 features a circumferential elevation 110 .
  • Hollow spaces 116 of connecting piece 100 engage into circumferential elevation 110 according to FIG. 2 a and are held for example by pressing following the attachment of the connecting piece onto elevation 110 .
  • FIG. 2 b illustrates a complete syringe body 101 with attached connecting piece 110 . Same components as in FIG. 2 are identified by the same reference numbers. This applies also to the top view according to FIG. 2 c.
  • FIGS. 3 a 1 to 3 c illustrates the attachment of the connection with the syringe body by means of material fit, for example by means of welding.
  • FIG. 3 a 1 shows a view of a syringe body 201 according to the invention, with a connecting piece 210 on syringe body 201 .
  • the syringe body in FIG. 3 a is a plastic syringe consisting of a hard material, for example cycloolefin-copolymer (COC) or cycloolefin-polymer (COP).
  • Syringe body 201 again includes a distal tip 203 with a distal opening 205 .
  • Connecting piece 210 is arranged around distal tip 203 , with an inside thread 212 for screwing in of a connector.
  • connecting piece 210 consists of a softer material than syringe body 201 , for example of polyethylene or polypropylene or COC-E.
  • the softer material can also be used in sections. In that case it is preferably used in areas where high forces occur when screwing in the connectors.
  • FIG. 3 a 2 details the area from FIG. 3 a 1 that shows the connection between separate connecting piece 210 and syringe body 201 .
  • This connection can occur selectively or over the complete support surface.
  • Separate connecting piece 210 is located with protrusions 212 of the syringe body. After placing separate connecting piece 210 on the syringe body, connecting piece 210 is joined the syringe body through coalescent fit, in other words material bonding, for example by means of welding, in particular ultrasonic welding.
  • connecting piece 210 or syringe body 201 have material provisions 220 , that—by means of a sonotrode—are caused to oscillate and thus to bond.
  • the ultrasonic welding can occur selectively or across the surface. If material provisions 220 are used, the welding occurs selectively. In heated ultrasonic welding the selection of the materials, especially their combination is important. If there is too great a difference between the fusion points, bonding of the materials is no longer possible
  • FIG. 3 b again illustrates in detail the entire syringe body 201 with ultrasonically welded connecting piece 210 .
  • FIG. 3 c is a top view of the design according to FIGS. 3 a 1 - 3 a 2 . Same components are identified with the same reference numbers.
  • the complete syringe body with connecting piece can be produced by a multicomponent injection molding process, instead of bonding the connector with the syringe body by means of welding, in particular ultrasonic welding. This is shown in FIGS. 4 a -4 b for a first embodiment, and in FIGS. 5 a -5 d for a second embodiment.
  • FIG. 4 a illustrates syringe body 301 , produced by multicomponent-injection molding.
  • Syringe body 301 includes again a connecting piece 310 in the region of syringe cone 303 with an inside thread 312 , consisting of a softer material than syringe body 301 .
  • the softer material is characterized by an E-module.
  • FIG. 4 b is an overall view of the syringe from FIG. 4 a .
  • the material of syringe body 301 is a hard plastic material, for example COC or COP
  • the material of connecting piece 310 is a soft material, for example polypropylene or polyethylene or COC-E.
  • clearly visible in FIG. 4 a is the inside thread of connecting piece 312 . Same components as in FIG. 4 a are identified with the same reference numbers.
  • FIGS. 5 a to 5 d illustrate a second embodiment of a syringe body 401 , produced by multicomponent injection molding.
  • Connecting piece 410 in the region of syringe body 401 again consists of a softer material.
  • the softer material has an E-module that is 10-60% lower than that of the hard material of the syringe body.
  • syringe body 401 has a circumferential seating 420 in the region of cover 421 of the syringe body.
  • the connecting piece consisting of a soft material engages into the seating.
  • a larger contact surface is provided that permits improved adhesion of the materials with each other.
  • FIG. 5 b shows the entire syringe with connecting piece 410
  • FIG. 5 c the top view
  • FIG. 5 d a three-dimensional view. Same components as in FIG. 5 a are identified with the same reference numbers.
  • the entire injection molded component is produced from two different plastics.
  • the injection molding machine includes two injection units, whereby however only one clamping unit is required.
  • the component that is produced in a multicomponent injection molding according to FIGS. 4 a -5 d can be produced cost effectively with only one tool in only one work cycle.
  • geometries can be realized that would not be possible on an assembly.
  • the invention provides for the first time a syringe body with which it is possible to connect a multitude of different connectors with one connecting piece, wherein the insertion torque can fluctuate in a wide range, wherein the thread does not transfer the mechanical stress to the syringe body, which would result there in leaks.
  • all materials of the syringe body as well as of the connecting piece are to be steam-sterilizable.
  • the materials are selected so that they do not change when in contact with pharmaceutical media. Due to the softer material of the connecting piece, the coefficient of friction between the connector and the syringe is met, so that the thread cannot be over tightened.
US15/860,285 2017-01-02 2018-01-02 Syringe including different materials Abandoned US20180207324A1 (en)

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KR20180080110A (ko) 2018-07-11
KR102389743B1 (ko) 2022-04-21
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JP2018108363A (ja) 2018-07-12
DE102017200007A1 (de) 2018-07-05
EP3342441A1 (de) 2018-07-04
JP7053250B2 (ja) 2022-04-12
JP7034346B2 (ja) 2022-03-11
EP3342441B1 (de) 2022-08-31
JP2021058710A (ja) 2021-04-15
US20230019725A1 (en) 2023-01-19

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