• 专利附录
  • 专利说明
  • 权利要求
  • 类似技术
  • 同族专利
  • 引用文献
  • 法律状态
  • 优先权
    • 专利摘要:
    FILLED SYRINGE. A filled syringe consists of a syringe cylinder (2) that is opened on one axial side and closed by a plug, which on the other axial side has a Luer-Lock connection (4), which is formed entirely in a front wall (3 ) that closes the syringe cylinder (2), with a free flow medium (8) filled in the syringe cylinder (2), with a soft elastic plug (9) that closes at least the Luer connection (5), and with an original closure (15) that surrounds the plug (9) outwards, with a theoretical breaking point. The syringe cylinder (2), the front wall (3) and the Luer-Lock connection (4) are made entirely as a plastic injection molding piece. The originality closure (15) consists of a synthetic material of the same or a similar type as the syringe cylinder (2) and is joined to the front wall (3) of the syringe cylinder (2) by means of welding. The welded joint is the theoretical breaking point, and the plug (9) is integrated into the original closure (15).
    公开号:BR112015006659B1
    申请号:R112015006659-3
    申请日:2013-09-26
    公开日:2021-01-19
    发明作者:Jochen Heinz
    申请人:Transcoject Gmbh；
    IPC主号:
    专利说明:

    [001] The present invention relates to a filled syringe which has a syringe cylinder, which on one axial side is opened and closed with a piston, and which on the other axial side has a Luer-Lock connection which is formed integrally with a front wall that closes the syringe barrel, and is closed by a plug.
    [002] Such filled syringes are used more and more, especially in the medical field, and have a free flowing medium as a filling, that is, typically a liquid or pasty substance, for example, a medication or a contrast agent. The ejection of the medium is provided by the piston that is inserted into the syringe cylinder, causing the medium to exit through the Luer cone opening of the Luer-Lock connection. In order to ensure that the medium in the syringe cylinder does not leave the Luer-Lock connection before use and that the syringe cylinder is hermetically sealed, especially it is protected against the entry of germs, a plug of an elastic material is provided soft that closes at least the Luer inside the Luer-Lock connection. This is to ensure, especially for medical products, that on the outside it is immediately recognizable if the tampon has already been removed once. For this purpose, a tamper-resistant closure is provided that has a separating rib that needs to be destroyed in order to reach the plug, in particular, to remove the Luer plug.
    [003] For syringe cylinders that consist of glass as they are used almost exclusively for medicinal products, it is part of the state of the art to place at the discharge end of the syringe cylinder a tamper-evident closure of plastic material such as a coupling closure together with a Luer connection and a plug that closes it (EP 0 397 951 A1). The problem with all these tamper-evident closures is that they, on the one hand, need to be so elastic that they can be pushed over a reinforcement on the side of the discharge end to engage there, on the other hand, however, the engagement lock is performed in a such that the tamperproof closure, when opened, breaks at the predetermined breaking point, and that the snap closure is not released. From the point of view of production technique, this is complex and requires great precision in manufacturing.
    [004] In comparison with this, the tamperproof closure known from DE 102 47 965 A1 is more advantageous where syringe cylinders and Luer Locks are made entirely as an injection molded piece of plastic material, and the plug and closure of inviolability, on the other hand, are joined to the syringe cylinder by means of a closed junction due to the material. The disadvantage, in this case, is that the plug must first be made as a separate component and be inserted into the tamper-evident closure which is also produced as a separate component, according to which the unit thus formed is welded or glued to the cylinder. syringe. Due to the predetermined breaking point foreseen in the tamper evident closure, after opening the tamper evident closure, a portion of the closure always remains on the side of the syringe, which is detrimental for several reasons. Thus, on the one hand, the Luer is not freely accessible on its outer circumference, on the other hand, the destroyed separation rib always means a certain risk of injury. In fact, it is envisaged as an alternative to perform the weld seam itself between the tamperproof closure and the syringe cylinder as a separating rib, but it is also problematic to perform the weld seam as a separating rib, as in this case there is also a risk of injury in the destruction of the separation rib.
    [005] Finally, the use of plastic material as a syringe cylinder for filled syringes has not given good results in medical technique, which is why for highly pure products, syringe cylinders made of special glass are always used.
    [006] In view of these facts, the present invention has the task of creating a filled syringe that largely avoids the disadvantages mentioned above, that can be produced cheaply and that is reliable and safe to use.
    [007] The filled syringe according to the present invention has a syringe cylinder that is opened on one axial side where it is closed by a piston, as is usual in such syringes, which, however, has on the other axial side a Luer connection -Lock that is formed entirely with a front wall that closes the syringe cylinder, that is, it is made integrally with the syringe cylinder and the front wall as an injection molded piece of plastic material. The free flowing medium at the tip, which can be pasty, liquid or possibly also gaseous, is kept inside, on the one hand, axially by the piston and the front wall with the Luer-Lock connection and, on the other hand, by the soft elastic cap. In this case, the plug closes at least the Luer, that is, the discharge cone itself, within the Luer-Lock connection. On the outside, the plug is surrounded by a tamper-evident closure that has a predetermined breaking point. The tamper-resistant closure is made of a plastic material equal to or similar to that of the syringe cylinder and is welded to the front wall of the syringe cylinder, and, according to the present invention, the weld joint is the predetermined breaking point , and the plug is part of the tamper-evident closure. Since, according to the present invention, the syringe barrel is made of a transparent plastic material, the contents of the syringe are visible from the outside, and this can be seen through the syringe barrel as well as through the front wall, up to into the Luer-Lock connection. Preferably, but not necessarily, the tamper-evident closure is also made of a transparent plastic material. In all cases it is made of the same or similar plastic material, so that the possibility of welding between the tamper-resistant closure and the front wall of the syringe cylinder is guaranteed.
    [008] Front wall in the sense of the present invention is the entire area between the Luer-Lock connection and the outer circumference of the syringe cylinder. Therefore, the tamper-resistant closure may eventually be aligned with the syringe barrel, or project completely or partially on it. By welding the tamperproof closure with the front wall of the syringe cylinder, the welding process can be carried out and monitored in a simple way, also in the production of large series.
    [009] In this, the essential advantage of the realization according to the present invention is that a separation rib does not need to be provided, as is the case in the state of the art, but that the weld joint itself is the predetermined breaking point, which, especially with the transparent execution of the components, offers the great advantage that after detaching the tamper-evident closure of the syringe, that is, after removing the welded joint or overcoming the welded joint, a surface of the front wall of the cylinder remains. syringe almost completely free of residues, which neither offers any risk of injury, nor restricts the view into the syringe cylinder. This last one is very important in the medical field, in order to exclude the accidental pulling of gas bubbles, or also just to be able to monitor by visual control the controlled outlet of the middle of the syringe cylinder for the Luer-Lock connection.
    [0010] Especially when the tamper-evident closure is also transparent, which is advantageous, it can already be seen before opening it, looking from the outside, the correct placement of the plug and the non-violation of the medium inside the cylinder the syringe. Therefore, the solution according to the present invention, in comparison with the state of the art, is an essentially cheaper solution than the syringe cylinders that until now consist of glass, at the same time, however, also a solution that can be considerably safer and better handling than is known in conventional syringes consisting of plastic material.
    [0011] It is especially advantageous when the tamper-resistant cap and closure are produced by means of two-component injection molding. In this way, it is possible to manufacture the plug from a suitable soft elastic thermoplastic material, and the tamper-evident closure, from a relatively hard plastic material, similar to that of the syringe cylinder. Two-component injection molding processes can be technically well mastered and, therefore, mean an inexpensive possibility, producing two parts in themselves independent of each other in an injection molding process almost entirely. This eliminates the need to mount the plug inside the tamper-evident closure, so that the production costs of the filled syringe can be reduced even further.
    [0012] In accordance with an advantageous improvement of the present invention, the tamper-evident closure and the plug are joined to each other with closure due to their shape. A union with a zipper due to the shape ensures that the plug is disposed inside the tamper-resistant closure with a zipper due to the shape, that is, it will always be handled with it. Such configuration of the components has the advantage that the materials used in the two-component injection molding process for tamper and tamperproof closure can be selected with greater freedom, since they do not need to form any joints either with closure due to the material or no other adherent joints, but in an extreme case they can be joined exclusively by means of the closure due to the shape. In this, the closure due to the shape between the plug and the tamperproof closure is formed outwardly and in a direction of rotation around the central longitudinal axis. With this arrangement, it is guaranteed that both in the rotation and in the tilting of the tamperproof closure at the tip, the plug is always moved together and thus, in the destruction of the predetermined breaking point, that is, of the welded junction between the tamperproof closure and the front wall of the syringe cylinder, the cap is also safely moved together and finally removed. Since the tamperproof closure surrounds the plug at the circumference, a relatively large manual force can be applied to the plug through it with the respective closure due to the shape, so that also with a firm plug seat inside the Luer connection or the Luer-Lock connection, when the cap surrounds the Luer connection also circumferentially, an easy release with manual force is also guaranteed.
    [0013] Advantageously, the syringe cylinder with the Luer-Lock connection formed entirely with it and possibly also the tamper-evident closure, consists of polyolefin. From this group of synthetic materials, many compounds are known that fulfill the special requirements of the material for a filled syringe, that is, they are transparent, guarantee a high stability of the form in the injection molding and constitute a great barrier against the penetration of the medium stored in the cylinder. the syringe. A cheap plastic material for the syringe barrel and Luer-Lock connection or tamper-evident closure is polypropylene. Alternatively, the syringe barrel advantageously can also consist of a cycloolefin copolymer or other suitable thermoplastic materials.
    [0014] Appropriately, the syringe cylinder consists of a plastic barrier material, the barrier properties being adjusted to the filling medium.
    [0015] Advantageously, the plug consists of a thermoplastic polymer and, in comparison with the material of the syringe cylinder, is soft and elastic. An especially suitable material for this is a thermoplastic polyurethane which can be handled well in the injection molding technique, especially in the two-component injection molding technique.
    [0016] In the following, the present invention is explained in more detail with the help of an example of execution shown in the drawing. He shows:
    [0017] Figure 1 shows in schematic representation, greatly simplified, the end on the outlet side of a syringe filled with the tamper-evident closure placed, in longitudinal section.
    [0018] Figure 2 shows a section along the cut line A-A in figure 1.
    [0019] Figure 1 shows only the part of the discharge side of a filled syringe 1. This syringe has a long syringe cylinder 2 which, at its axial end, not visible in figure 1, is open, and which is closed by a plug, also not shown, which is displacably guided inside the cylinder 2. On the other side , the axial side shown in figure 1, the syringe cylinder 2 is closed by a front wall 3 where a Luer-Lock connection 4 is integrally formed. The syringe cylinder 2, the front wall 3 and the Luer-Lock connection 4 are produced as an injection molded part of plastic material and consist of a material as indicated above by way of example and as being advantageous. The Luer-Lock 4 connection, in a manner known per se, consists of an internal Luer 5 cone which corresponds to a usual Luer-Lock connection and which has an internal passage channel 6 for the syringe cylinder 2. The Luer 5 connection is surrounded by a cylindrical segment 7 that carries an internal thread on its internal side and together with the Luer 5 connection constitutes the Luer-Lock 4 connection in a manner known per se.
    [0020] The medium 8 that is in the syringe cylinder 2 is hermetically closed in the circumference by means of the syringe cylinder 2, on the non-visible axial side, by the plug, and on the other axial side, closed by the front wall 3 and by the connection Luer-Lock 4, by means of a plug 9. The plug 9 consists of a soft elastic thermoplastic material and has a conical protrusion 10, oriented into the passage channel 6 of the Luer 5 connection which closes the passage channel 6 hermetically to outside. The protrusion 10 is followed, at a radial distance, by an annular segment 11 that protrudes clearly over the protrusion 10 towards the syringe cylinder 2 at its axial length. This annular segment 11 surrounds the Luer cone 5 in the circumference, therein an annular groove is formed between the projection 10 and the annular segment 11 where it engages the free end of the Luer cone 5. The seal is provided, on the one hand, by the projection 11 that closes the free end of the passage channel 6, and, on the other hand, through the annular segment 11 that seals against the outer circumference of the Luer cone 5. The projection 10 and the annular segment 11 become an essentially cylindrical segment 12 that has five ribs 13 of radial extension that end in a central space 14.
    [0021] In the area of the ribs 13 and the central space 14, the plug 9 is crossed by a component of plastic material that constitutes an inviolability closure 15. This inviolability closure 15 has beside the segments that project into the spaces free 13 and 14 an annular segment 16 surrounding the plug 9 to the proximity of the axial end of the projection 10. This annular segment 16, by means of an area interrupted by roughing 17 arranged in a ring shape, is connected to an annular segment 18 radially enlarged, which, with its cylindrical internal diameter, leans with a small gap to the outer circumference of the cylindrical segment 7 of the Luer-Lock connection 4 and extends to the front wall 3, where, in parts, it is welded to it. In this, the ring segment 18 tapers towards the front wall 3, with ribs 19 parallel to the axis, which increase the ease of handling of this segment.
    [0022] As shown in figure 1, the ring segment 18 is not completely welded to the front wall 3, but only in segments, similar to the roughing arrangement 17 on the other axial side of the tamperproof closure. Due to the fact that the ring segment 18 is only partially welded to the front wall 3 of the syringe cylinder 2, a predetermined breaking point is formed between these two components that can be broken by simple manual force. In this, the welded joint is released, that is, after opening the tamper-evident closure, the front wall 3 remains almost in its original shape, that is, it remains flat and smooth and essentially transparent, so that the view to the inside the syringe 1 and thus the filling medium 8 through the transparent plastic material of the syringe cylinder is possible. Therefore, it is in particular the discharge area of the syringe 1 that is visible after the removal of the tamper evident closure 15, and thus, in a simple way, it can be visually monitored. The surface of the front wall 3 is smooth and essentially free of debris from the tamper evident closure 15.
    [0023] The plug 9, which in the embodiment shown is not transparent, is crossed by the tamper evident closure 15 which also consists of a transparent thermoplastic plastic material, so that, on the one hand, after the assembly of this component consisting of plug 9 and tamper-resistant closure 15 and is produced with the two-component injection molding process, the correct seat of the plug 9 is always guaranteed, on the one hand, and on the other hand, when breaking the welded joint, a movement is also guaranteed and thus, a removal of the plug 9. It is evident that the materials constituting the plug 9 and the tamper-evident closure 15 do not need to enter any closure due to the material, but that the closure due to the shape conditioned by the construction between these two components is enough to put these together firmly and inseparably.
    [0024] As the sectional representation according to figure 1 makes evident, the component produced with the two-component injection molding process consisting of plug 9 and tamper-evident closure 15, is performed in such a constructive way that when placing of this component in the syringe, the inner side of the ring segment 18 is guided on the outer side of the cylindrical segment 7 of the Luer-Lock connection 4. Thanks to this cylindrical guide, first the ring segment 18 is placed in the Luer connection 5, and in the phase At the end of the assembly process, the projection 10 is inserted at the end of the passage channel 6 in a sealing manner. Through this guide, it is guaranteed that the plug 9 always closes the Luer 5 connection according to its destination. Through the arrangement of the ring segments 21 with which the tamper evident closure 15 is welded with the front wall 3 of the syringe, these welding seam segments can also be produced simply in production in large series, since the areas are very accessible. This production process can also be controlled, not only by visual control, but also through other suitable control processes. Finally, at this exposed point of the syringe, it is immediately visible when the tamper-resistant closure 15 is broken, that is, the welded joint is separated from the front wall 3. This is evident especially from the fact that the weld is not continuous, but only in the area of the segments on the front side 21, so that in the removal and replacement of the tamper evident closure 15, a rotation typically occurs around the central longitudinal axis 20 that is visible in the front wall 3, since then the welding points are no longer align more with segments 21 on the front side. Reference List 1 Syringe 2 Syringe Cylinder 3 Front Wall 4 Luer-Lock Connection 5 Luer Cone, Luer Connection 6 Through Channel 7 Cylinder Segment 8 Filling Medium 9 Buffer 10 Overhang 11 Ring Segment 12 Cylindrical Segment 13 Ribs 14 Central Space 15 Tamperproof closure 16 Ring segment 17 Roughing 18 Ring segment 19 Ribs 20 Central longitudinal axis 21 Segments on the front side
    权利要求:
    Claims (11)
    [0001]
    1. Syringe filled with a syringe cylinder (2) that is opened on one axial side and closed by a piston, which on the other axial side has a Luer-Lock connection (4), which is formed entirely in a front wall ( 3) closing the syringe cylinder (2), with a free flow medium (8) filled in the syringe cylinder (2), with a soft elastic plug (9) that closes at least the Luer connection (5), and with a tamperproof closure (15) that surrounds the plug (9) outward with a predetermined breaking point, characterized by the fact that the syringe cylinder (2), the front wall (3) and the Luer-Lock connection ( 4) are made entirely as an injection molding piece of plastic material, the tamper-evident closure (15) consists of a plastic material of the same or a similar type as the syringe cylinder (2) and which is joined to the front wall (3) of the syringe cylinder (2) by means of welding, the welded joint constituting the predetermined breaking point and the plug (9) is integrated into the tamper evident closure (15).
    [0002]
    2. Filled syringe, according to claim 1, characterized by the fact that the plug (9) and the tamper-evident closure (15) are produced in the two-component injection molding process.
    [0003]
    3. Filled syringe according to claim 1 or 2, characterized by the fact that the tamper evident closure (15) and the plug (9) are joined together with closure due to the shape.
    [0004]
    4. Filled syringe according to any one of the preceding claims, characterized by the fact that the tamper evident closure (15) is transparent.
    [0005]
    5. Filled syringe according to any one of the preceding claims, characterized by the fact that the closure due to the shape between the plug (9) and the tamper evident closure (15) is formed outwardly and in the direction of rotation around the central longitudinal axis (20).
    [0006]
    6. Filled syringe according to any one of the preceding claims, characterized by the fact that the syringe cylinder (2) consists of a polyolefin.
    [0007]
    7. Filled syringe according to claim 5, characterized by the fact that the syringe cylinder (2) consists of polypropylene.
    [0008]
    8. Filled syringe according to any one of the preceding claims, characterized by the fact that the syringe cylinder (2) consists of a cycloolefin copolymer.
    [0009]
    9. Filled syringe according to any one of the preceding claims, characterized in that the syringe cylinder (2) consists of a plastic barrier material whose barrier properties are adjusted to the filling medium (8).
    [0010]
    10. Filled syringe according to any one of the preceding claims, characterized in that the plug (9) consists of a thermoplastic polymer (TPE).
    [0011]
    11. Filled syringe according to any one of the preceding claims, characterized by the fact that the plug (9) consists of a thermoplastic polyurethane (TPU).
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    同族专利:
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    SG11201502174RA|2015-05-28|
    PH12015500660B1|2015-05-11|
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    UA113893C2|2017-03-27|
    CN110237361A|2019-09-17|
    RU2015115497A|2016-11-20|
    JP2015530167A|2015-10-15|
    AU2013322638B2|2017-09-14|
    PT2900301T|2016-11-08|
    KR20150063395A|2015-06-09|
    HK1212269A1|2016-06-10|
    DK2900301T3|2017-01-02|
    CN110237368A|2019-09-17|
    BR112015006659A2|2017-07-04|
    WO2014049097A1|2014-04-03|
    SA515360183B1|2018-05-30|
    NZ706006A|2017-03-31|
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    US20150246185A1|2015-09-03|
    EP2900301A1|2015-08-05|
    PH12015500660A1|2015-05-11|
    AU2013322638A1|2015-04-23|
    SI2900301T1|2016-11-30|
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    法律状态:
    2018-11-21| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|
    2019-11-12| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|
    2020-11-24| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|
    2021-01-19| B16A| Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 26/09/2013, OBSERVADAS AS CONDICOES LEGAIS. |
    优先权:
    申请号 | 申请日 | 专利标题
    US201261706047P| true| 2012-09-26|2012-09-26|
    US61/706,047|2012-09-26|
    PCT/EP2013/070140|WO2014049097A1|2012-09-26|2013-09-26|Prefilled syringe|
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