NL1021236C2 - Injection syringe assembly includes liquid holder, plunger, injection needle, sealing element, and removable member for fixing sealing element in first position - Google Patents

Abstract

An injection syringe assembly comprises a liquid holder (2), a plunger, an injection needle (7), a first sealing element (9) which prevents liquid (10) present in the liquid holder from passing to the injection needle, and a removable member (20) for fixing the first sealing element in the first position. An injection syringe assembly comprises a liquid holder with outlet opening (3); a plunger which can be displaced within the liquid holder and has a plunger head to which a plunger rod is or can be secured; an injection needle with needle mount (8) which can be secured in the outlet opening of the liquid holder; a first sealing element which prevents liquid present in the liquid holder from passing to the injection needle, it being possible for the first sealing element to adopt a first position, in which liquid in the liquid holder is prevented from passing to the injection needle, and a second position, in which liquid which is present in the liquid holder is allowed to pass to the injection needle; and a removable member for fixing the first sealing element in the first position.

Description

AO 2-50065 / JPO / RST

Brief indication: Syringe assembly

The present invention relates to a syringe assembly. Various syringe assemblies are known in practice.

A problem that arises with known syringe assemblies is that if the syringe assemblies are filled in large numbers at the injection site itself, such as in the case of a vaccination campaign, the filled syringe assemblies must be stored for several hours after filling. As a result, degradation of the liquid filled in the liquid container can take place through contact with the air. Even if a protective cap is placed after the filling of the known syringe assemblies, this degradation cannot be completely prevented. Moreover, contact of liquid filled in the liquid container of the injection syringe assembly with the injection needle can lead to corrosion of the injection needle on the one hand and contamination of the liquid on the other. Incidentally, the same problem also occurs with pre-filled syringes that have been filled under controlled conditions by a manufacturer of liquid to be injected and delivered in a filled state.

Another problem that arises with known syringe assemblies is that with these syringe assemblies there is the possibility of replenishing the liquid container during use via the injection needle.

It will be clear that this is extremely undesirable because of the risk of contamination.

It is an object of the present invention to solve one or more of the above and other problems.

It is a further object of the present invention to provide a leak-free syringe assembly that is easy to produce and also easy to use.

It is yet another object of the present invention to provide a leak-free syringe assembly that can be produced with as few parts as possible and as cheaply as possible.

These objects are achieved by the present invention through a syringe assembly, at least comprising: a liquid container with outflow opening; a piston displaceable in said liquid container with a piston head to which a piston rod is or can be attached; an injection needle with needle mount that is or can be attached in the outflow opening of the liquid container; and a first sealing element that can prevent passage of liquid present in the liquid container to the injection needle; wherein the first sealing element can take a first position in which passage of liquid present in the liquid container to the injection needle is prevented, and a second position in which passage of liquid present in the liquid container to the injection needle is made possible.

The syringe assembly according to the invention makes it possible to store fluid filled in the fluid container of the syringe assembly substantially degradation-free and leak-free, without the need for a protective cap to be used. The assembly can be packaged if desired.

A further advantage of the syringe assembly according to the invention is that the interim refilling of liquid in the liquid container is made substantially impossible by suction via the injection needle, which minimizes the chance of contamination. The first sealing element may possibly be. be arranged in such a way that refilling by fast and powerful suction of new liquid is impossible because the sealing element then immediately comes into the first position, while slow suctioning ('aspiration') of blood, for example, is possible. It will be clear that this slow suctioning is not suitable for topping up the liquid container.

An important advantage of the assembly according to the invention is furthermore that it can be sterilized both in the empty, assembled state and in the filled state, without this affecting the liquid tightness of the assembly.

Another advantage of the assembly according to the invention is that injection of the liquid can be carried out "with feeling", in other words a certain resistance does not have to be overcome to bring the first sealing element from the first to the second position.

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The assembly according to the invention can be made from a small number of different materials, which is highly desirable in the art.

The person skilled in the art will understand that the syringe assembly according to the invention is not limited to empty, yet to be filled syringes, but can also be valuable for use in other types of syringes, such as, for example, pre-filled syringes, as long as it is desired that the first sealing element can take a first and second position.

The person skilled in the art will understand that the attachment of the needle mount with injection needle into the outflow opening can be carried out in many ways, as long as a certain and stable attachment is provided.

The first sealing element according to the invention can be of any suitable shape, and be made of any suitable material, as long as it is ensured that passage of liquid present in the liquid container to the injection needle in the first position is substantially prevented and passage of in the liquid container to the injection needle in the second position is made possible. Preferably, the first sealing element forms part of the needle mount for ease of assembly.

According to a first preferred embodiment, the first sealing element is placed upstream of the injection needle, that is to say that the first sealing element is situated on the one hand between the interior of the liquid container and on the other hand the opening of the injection needle through which the liquid coming from the liquid container will enter the injection needle. The sealing element is herein preferably at least partially included in the needle mount, so that an assembly advantage is provided.

According to a second preferred embodiment, the first sealing element at least partially surrounds the injection needle and the injection needle comprises an opening in its side wall in or near the needle mount, such that in its first position the sealing element opens the opening in the side wall of the injection needle and, in its second position, substantially releases the opening in the side wall of the injection needle.

The needle mount advantageously comprises one or more openings. As a result, if the first sealing element finds itself in the

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In the second position, the passage of liquid present in the fluid container to the injection needle takes place through the one or more openings in the needle mount.

According to a particularly preferred embodiment of the injection syringe assembly according to the invention, the assembly comprises a second sealing element in the outflow opening of the liquid container, the second sealing element being made of a resilient sealing material and having a passage for the injection needle.

This further improves the leak-tightness of the syringe assembly. Moreover, the sealing element reduces the chance that the injection needle, if a so-called retractable injection needle is used, after it has been retracted into the liquid container, accidentally comes out again through the outflow opening of the liquid container. After all, the resilient sealing material of the second sealing element, such as, for example, silicone rubber, ensures that the passage for the injection needle is sealed after it has been withdrawn into the liquid container.

Since, in practice, the injection needles are often made of tubular material that is unwound from large spools, these injection needles are often slightly curved, so that after the injection needle is pulled into the liquid container, it no longer tends towards the center, but rather towards the wall the liquid container is inclined. As a result, the chance that the injection needle manages to find the passage of the sealing element is further minimized.

Advantageously, the syringe assembly is designed such that the injection needle can be withdrawn into the liquid container after use. This prevents the injection needle from being used again after use. Retractable injection needles are known per se from the art and therefore need not be explained in more detail here. Such a retractability of the injection needle can for instance be provided in that the needle mount of the injection needle and the piston head of the piston 35 comprise cooperating coupling means which can be coupled after use (i.e. after emptying the liquid container) so that the injection needle in the liquid container can be withdrawn. According to a preferred embodiment, the assembly is:. .1) n - 5 according to the invention provided with a retractable needle as described in NL-1 020 937.

It is preferred that the assembly further comprises a protective cap that is or can be attached to the liquid container. As a result, the injection needle is protected against damage and, moreover, the leak-tightness - if a pre-filled syringe is used - can be improved.

It is furthermore advantageous if the assembly additionally comprises a member for fixing the first sealing element in the first position. This facilitates the filling of the liquid container 'behind' (i.e. via the end of the liquid container remote from the outflow opening), without the liquid to be filled being able to leave the liquid container via the injection needle.

In this connection it is particularly preferred if the member forms part of the protective cap, since this reduces the number of parts to be used. This embodiment also improves the ease of use.

The liquid container is advantageously filled with liquid; A pre-filled syringe assembly is hereby obtained. Pre-filled syringes can be supplied by the manufacturer of the liquid to be injected with a liquid container filled under controlled conditions. Instead, the syringes can also be filled for a few hours before use in, for example, the hospital. It has been found to be advantageous (in particular in the case of pre-filled syringes supplied by the manufacturer) if the assembly is in any case sterilized after the liquid has been filled into the liquid container. Hereby contamination of the assembly according to the invention is prevented and the assembly can thus be stored longer. Of course, if desired and preferably, a sterilization can also be carried out prior to assembly of the assembly and filling of the liquid container. The assembly is therefore preferably double sterilized.

According to a very favorable preferred embodiment, the assembly is arranged such that during storage there is no contact between liquid present in the liquid container and the injection needle. This prevents corrosion of the injection needle on the one hand and, on the other hand, contamination of liquid present in the liquid container.

The present invention furthermore relates to a needle mount, a needle mount provided with an injection needle, a first sealing element and a protective cap which are apparently intended for a syringe assembly according to the invention. The needle mount provided with the injection needle is preferably siliconized (i.e. coated with a layer of silicone). This prevents the first sealing element from becoming stuck in a certain position after prolonged storage.

The invention will be explained in more detail below with reference to the accompanying, non-limiting drawing. Herein: - Figure 1 shows a schematic section of a syringe assembly according to the invention; Figure 2 shows the syringe assembly according to Figs. 1, wherein the first sealing element is in the second position; Figure 2A is a perspective view of the needle mount used in Figs. 1 and 2; Figure 2B is a perspective view of the first sealing element used in Figures 1 and 2; Figure 3 shows a schematic cross-section of an alternative embodiment of a syringe assembly according to the invention, wherein the needle mount is assembled 'rearwards'; Figure 4 shows the syringe assembly according to Figs. 3, wherein the first sealing element is in the second position; Figure 4A is a perspective view of the needle mount as used in Figures 3 and 4.

Figure 5 shows a schematic section of a further alternative embodiment of the syringe assembly according to the invention; Figure 6 shows a schematic section of yet another alternative embodiment of the syringe assembly according to the invention; Figure 7 shows the syringe assembly according to Figs. 6, wherein the first sealing element is in the second position; and - Figures 8 and 9 are a schematic cross-section of a further embodiment of the syringe assembly, the first sealing element being in the first and second position, respectively.

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Equal reference numbers refer to comparable parts. For reasons of clarity and clarity, not all elements normally present are always indicated.

Figure 1 shows a partial schematic cross-section of a syringe assembly 1 according to the invention. The syringe assembly 1 comprises a liquid container 2 with outflow opening 3. In the liquid container 2 there is a movable piston 4 with a piston head 5 to which a piston rod 6 is attached. Furthermore, an injection needle 7 (generally made of stainless steel) with needle mount 8 is present, the needle mount 8 being mounted in the outflow opening 3 of the liquid container 2. Furthermore, a sealing element 9 is present which is in a first position thereof, as a result of which passage of liquid 10 present in the liquid container 2 to the injection needle 7 is prevented. The sealing element 9 can also assume a second position, as shown in Figure 2, whereby passage of liquid 10 present in the liquid container 2 to the injection needle 7 is made possible. The first sealing element 9 forms part of the needle mount 8 and is incorporated therein, and is placed "upstream" of the injection needle 7, that is to say that the liquid 10 present in the liquid container 2 when injected, if the first sealing element 9 is in the second position, first passes the first sealing element 9 and only then leaves the syringe assembly 1 via the injection needle 7. In order to allow fluid 10 from fluid container 2 to reach the entrance of the injection needle 7 at all, the needle mount is provided with one or more openings 11. In the embodiment shown, the openings 11 are sealed in the first position of the sealing element 9.

The sealing element 9 will preferably be made of a resilient material such as silicone rubber.

In the embodiment shown, the assembly 1 comprises in the outflow opening 3 of the liquid container 2 a second sealing element 12 which is made of a resilient sealing material such as silicone rubber and has a passage 13 for the injection needle 7. Because the second sealing element 12 is made of a resilient material is thereby provided in an improved leak-tightness of the pre-filled syringe 1.

In use of the syringe assembly according to Figure 1, the assembly 1 will first be filled with liquid 10, for example with the aid of a suction needle known in the art. After that the suction needle will be removed and the injection needle 7 with needle mount 8. With the aid of the coupling means 15, also known in the art, a stable attachment of the needle mount 8 with injection needle 7 to the outflow opening 3 of the liquid container 2 is obtained. The coupling means 15 moreover contributes to a good liquid-tightness of the whole.

When placing the needle mount 8 with injection needle 7, the sealing element 9 is in the first position, whereby passage of liquid 10 to the injection needle 7 is prevented.

When injecting the liquid 10, the piston head 5 can be moved in the direction of the outflow opening 3 by means of the piston rod 6, so that the sealing element 9 is driven into its second position, so that passage of liquid 10 to the injection needle 7 becomes possible made. The second position of the sealing element 9 is clearly shown in Figure 2. The direction of flow of the liquid 10 in Figs. 2 shown.

The interim refilling of new liquid 10 (in which the injection needle 7 is then used as suction needle) is substantially prevented, since as a result the sealing element 9 will move back into the first position (see Figure 1), whereby a sealing action is again obtained .

After the liquid container 2 has been emptied, the injection needle 7 can be withdrawn into the liquid container 2 because a coupling 25 takes place between the needle mount 8 and the end of the piston head 5 of the piston 4 facing the outflow opening 3. For a further explanation of the manner of coupling between needle mount 8 and piston head 5, reference is made to Dutch application 1 020 937.

Withdrawing the injection needle 7 into the liquid container 2 after use is preferably carried out as described in this Dutch application 1 020 937.

The resilient second sealing element 12 prevents, after withdrawing the injection needle 7, from accidentally coming out again through the outflow opening 3 of the liquid container 2, because the passage 13 closes.

Fig. 2Ά shows a perspective view of the needle mount 8 with injection needle 7, as used in Figs. 1 and 2. The opening in the needle mount 8 is indicated by 11, through which the liquid 10 102) 2 3-8-9 will pass through in the second position of the sealing element 9 (see Fig. 2).

Figure 2B shows a perspective view of the first sealing element 9 as used in Figures 1 and 2.

Figure 3 shows a partial cross-section of an alternative embodiment of the assembly 1. In the embodiment shown in Figure 3, the assembly 1 is in the form of a pre-filled syringe, i.e. the liquid container 2 is already filled, for example, at the factory and is supplied as such.

The needle mount 8, needle 7 and ring 14 (see discussion Figs. 6 and 7) are assembled 'rearwards', i.e. via the end of the liquid container 2 remote from the outlet opening 3. The assembly 1 according to Fig. 3 comprises a The protective cap 16 is connected to the liquid container 2 and must be removed before use, for example by breaking off. To this end, the syringe 1 has a thinner wall at the interruption point indicated by 17 in the drawing. Instead, the protective cap 16 can of course also be made unscrewable. The syringe may be sterilized after assembly and filling.

Figure 3 shows the first sealing element 9 in the first sealing position. Figure 4 shows the pre-filled syringe according to Figure 3, wherein the first sealing element 9 is in the second position, as a result of which liquid 10 present in the liquid container 2 can move to the injection needle 7. Fig. 4A shows a perspective view of the needle mount 8 as used in Figs. 3 and 4. Arrows indicate the fluid flow as referred to in Figs.

4 indicated.

The pre-filled syringe 1 shown in Figures 3 and 4 is easy to produce, assemble and operate. When new liquid 10 is sucked in, the first sealing element will return to the first position and thus close the injection needle.

Figure 5 shows a partial section of an alternative embodiment of the syringe assembly 1, wherein the first sealing element 9 at least partially surrounds the injection needle 7 and wherein the injection needle 7 in or near the needle mount 8 comprises an opening 19 in the side wall 18 thereof, and others such that in its first position the sealing element 9 seals the opening in the side wall 18 of the injection needle 17 (Figure 5) and in its second position the opening in the side wall 18 of the injection needle 1 µl. r * 3 6-10 release (compare figures 6 and 7). The sealing element 9 can easily slide back and forth over the injection needle 7 to take its first or second position (for this purpose a layer of silicone can be applied over the outside 18 of the needle 7). However, in this case the sealing element 9 is arranged such that no liquid 10 can flow between the sealing element 9 and the needle 7 or between the element 9 and in this case the coupling element 15.

Furthermore, Figure 6 shows an embodiment of the assembly 1 which is comparable to Figure 5 with regard to the positioning 10 of the first sealing element 9, wherein the assembly is again in the form of a pre-filled syringe. The first sealing element 9 is shown in the first position. The protective cap 16 comprises a "sterilization window" 21, through which the assembly 1 can be sterilized in the pre-filled and still sealed state (i.e. the protective cap 16 is still connected to liquid container 2). The sterilization window 21 can be made of, for example, paper or another material suitable for this purpose, which makes it possible to sterilize the injection needle 7. After sterilization, the window 21 prevents contamination of the injection needle 7 by its sealing action. In FIG. 7, the first sealing element is in the second position. Moreover, the protective cap 16 has been removed from the liquid container 2 to enable injection.

After withdrawal of the injection needle 7 into the liquid container 2, the first sealing element 9 exerts a comparable effect to the second sealing element 12 of FIG. 1-2, whereby the injection needle 7 is prevented from going out again through the outflow opening 3. Between the front part of the liquid container 2 and the first sealing element 9 there is furthermore a ring 14 made of a hard material. As soon as the needle 7 is withdrawn into the liquid holder 2 after the liquid container 2 has been emptied, the tip of the needle 7 will abut against the ring 14, whereby the injection needle 7 will be rendered completely harmless without additional actions.

Finally, figures 8 and 9 show a schematic section of a further embodiment of the syringe assembly according to the invention. The member 20, which in the embodiment shown forms part of the protective cap 16, ensures - in cooperation with the ring 14 - for a certain fixation of the first sealing element 9%.

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In the first position, as long as the protective cap 16 is mounted on the liquid container 2. The ring 14 is thereby designed such that, after removal of the protective cap 16 and starting to empty the liquid container 2, it will move along with the sealing element 9, whereby the sealing element 9 ends up in the second position (Fig. 9).

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Claims (18)

A syringe assembly (1), comprising at least: 5. a liquid container (2) with outflow opening (3); a piston (4) displaceable in said liquid container (2) with a piston head (5) to which a piston rod (6) is or can be attached; an injection needle (7) with needle mount (8) that is or can be attached in the outflow opening (3) of the liquid container (2); and a first sealing element (9) that can prevent passage of liquid (10) present in the liquid container (2) to the injection needle (7); Wherein the first sealing element (9) can take a first position in which passage of liquid (10) present in the liquid container (2) to the injection needle (7) is prevented, and a second position in which passage of liquid present in the liquid container (2) is prevented. liquid (10) to the injection needle (7) is made possible. A syringe assembly according to claim 1, wherein the first sealing element (9) is positioned upstream of the injection needle (7). 3. Syringe assembly according to claim 1, wherein the first sealing element (9) at least partially surrounds the injection needle (7) and wherein the injection needle (7) in or near the needle mount (8) has an opening (19) in the side wall (18) thereof, such that the first sealing element in its first position seals the opening (19) in the side wall (18) of the injection needle 30 (7) and in its second position the opening (19) in the side wall ( 18) of the injection needle (7) substantially free. A syringe assembly according to one or more of the preceding claims, wherein the needle mount has one or more openings (11). 5. Syringe assembly according to one or more of the preceding claims, wherein the first sealing element (9) comprises a resilient material. Injection syringe assembly according to one or more of the preceding claims, wherein the assembly (1) in the outflow opening (3) of the liquid container (2) comprises a second sealing element (12), 1. · '; Wherein the second sealing element (12) is made from a resilient sealing material and has a passage (13) for the injection needle (7). 7. Syringe assembly according to one or more of the preceding claims, wherein the injection needle (7) can be withdrawn after use into the liquid container (2). 8. Syringe assembly according to one or more of the preceding claims, characterized in that the assembly (1) further comprises a protective cap (16) which is or can be attached to the liquid container (2). A syringe assembly according to one or more of the preceding claims, characterized in that the assembly (1) furthermore comprises a member (20) for fixing the first sealing element (9) in the first position. The syringe assembly according to claims 8 and 9, characterized in that the member (20) forms part of the protective cap (16). A syringe assembly according to one or more of the preceding claims, characterized in that the liquid container (2) is filled with liquid (10). A syringe assembly according to claim 11, characterized in that the assembly (1) is sterilized in the fluid container (2) after the liquid (10) has been filled. 13. Syringe assembly according to one or more of the preceding claims, characterized in that the assembly (1) is arranged such that during storage there is no contact between liquid (10) present in the liquid container (2) and the injection needle (7) . A needle mount (8) apparently intended for a syringe assembly (1) according to one or more of the preceding claims 1-13. A needle mount (8) provided with an injection needle (7) apparently intended for a syringe assembly according to one or more of the preceding claims 1-13. The needle mount (8) according to claim 15, characterized in that the needle mount (8) is siliconized after attachment of the injection needle (7). 17. First sealing element (9) apparently intended for a syringe assembly (1) according to one or more of the preceding claims 1-13. ;; > '·'.> 5 ··. i i \ j · / - 14- A protective cap provided with a member (20) apparently intended for a syringe assembly according to one or more of the preceding claims 1-13. t