Short title: Injection syringe assembly
The present invention relates to an injection syringe assembly. Various injection syringe assemblies are known in practice.
One problem which arises with known injection syringe assemblies is that if the injection syringe assemblies are filled in large numbers at the actual location of injection, as in the case of an inoculation campaign, the filled injection syringe assemblies have to be stored for a number of hours after they have been filled. This can cause the liquid which has been introduced into the liquid holder to be degraded through contact with air. Even if a protective cap is fitted after the known injection syringe assemblies have been filled, it is not possible to completely eliminate this degradation. Moreover, contact between liquid which has been introduced into the liquid holder of the injection syringe assembly and the injection needle can on the one hand cause corrosion of the injection needle and on the other hand cause contamination of the liquid. The same problem incidentally also arises with prefilled injection syringes which are filled with liquid which is to be injected by a manufacturer under controlled conditions and are supplied in the filled state.
Another problem which arises with known injection syringe assemblies is that with these injection syringe assemblies there is the possibility of topping up the liquid holder via the injection needle during use. It will be clear that this is extremely undesirable, on account of the risk of contamination.
US-A 5,704,918 describes an injection syringe which may contain one or more different injection liquids, which injection syringe is supposed to be suitable for storage for a prolonged period of time. The injection syringe described in US-A 5,704,918 may include a 'partition 311' (cf. Fig. 11 of US-A 5,704,918) made from a flexible resin, which can adopt a position which prevents liquid present in the liquid holder from passing to the injection needle and another position in which this passage of liquid is made possible.
However, a significant drawback of the injection syringe which is known from US-A 5,704,918 is that the 'partition 311' can easily be unintentionally moved into the position which allows liquid to pass, so that liquid can unintentionally escape from the liquid holder. In addition to the fact that this can cause expensive injection liquid to be lost, it wilX be clear that this is also highly undesirable with a view to preserving liquid which is present in the liquid holder.
Consequently, the Injection syringe described in US-A 5,704,918 is not completely free of leaks and degradation as is intended by the present invention.
It is an object of the present invention to solve one or more of the above problems and other problems.
Furthermore, it is an object of the present invention to provide a leak-free injection syringe assembly which is simple to produce and also simple to use.
Yet another object of the present invention is to provide a leak-free injection syringe assembly which can be produced with the minimum possible number of components and at the lowest possible cost.
These objects are achieved by the present invention by means of an injection syringe assembly, at least comprising: a liquid holder with outlet opening; a plunger which can be displaced within the said liquid holder and has a plunger head to which a plunger rod is or can be secured; an injection needle with needle mount which is or can be secured in the outlet opening of the liquid holder; a first sealing element which is able to prevent liquid which is 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 which is present 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 member for fixing the first sealing element in the first position.
The injection syringe assembly according to the invention enables liquid which has been introduced into the liquid holder of the injection syringe assembly to be stored substantially without any degradation or leaks and without a protective cap having to be used. On account of the presence of the fixing member, the first sealing element remains in place even if an overpressure is present in the liquid holder. The overpressure in the liquid holder may have been produced, for example, by the operation of filling the liquid holder, or alternatively the overpressure may be present during the filling of the liquid holder. The assembly can be packaged if desired.
A further advantage of the injection syringe assembly according to the invention is that it is made substantially impossible for liquid in the liquid holder to be subsequently topped up by suction via the injection needle, which minimizes the risk of contamination. The first sealing element may in this case if appropriate be designed in such a manner that topping up by quickly and powerfully sucking up new liquid is impossible as a result of the sealing element then immediately moving into the first position, whereas slow suction ( Λ aspiration' ) of, for example, blood is possible. It will be clear that this slow suction is not suitable for topping up the liquid holder.
A significant advantage of the assembly according to the invention is also that it can be sterilized both in the empty, assembled state and in the filled state without this detracting from the liquid seal of the assembly. Also, the liquid which is present in the liquid holder is not affected if the assembly is sterilized in the prefilled state.
Another advantage of the assembly according to the invention is that the liquid can be injected 'by touch' , in other words as soon as the first sealing element has been moved into its second position, there is no need to overcome any resistance (in the assembly) to discharge the liquid.
Yet another advantage of the inj ection syringe according to the present invention is that filling of the liquid holder ' from the rear' ( i . e . via that end of the liquid holder which is remote from the outlet opening) or in some other way is made easier without liquid which is to be introduced being able to leave the liquid holder via the inj ection needle at this stage (on account o f the fact that the first sealing element moves into its second position as a result of the filling operation) .
The assembly according to the invention can be filled in a very simple and efficient way with the aid of automatic filling devices which are known from the prior art, even if the assembly i s designed in the form of an inj ection needle which can be retracted into the liquid holder after use . The person skilled in the relevant art will quickly recogni ze that this is very special . It is preferable for the member for fixing the first sealing element to interact for this purpose with the needle mount, which member and needle mount are preferably both positioned in or close to the outlet opening of the liquid holder, so that these components are not ' in the way' while the liquid holder is being filled ' from the rear' .
The assembly according to the invention may be made from a small number of different materials , which is highly desirable in the relevant field.
The person skilled in the relevant art will understand that the inj ection syringe assembly according to the invention is not restricted to empty injection syringes which are yet to be filled, but rather may also be of value for use in other types of inj ection syringes , such as for example prefilled inj ection syringes , provided only that it is desired for the first sealing element to Joe able to adopt a first position and a second position .
The person skilled in the relevant art will understand that the needle mount with inj ection needle can be secured in the outlet opening in numerous ways , provided only that secure and stable securing is achieved.
The first sealing element according to the invention may take any suitable form and may be made from any suitable material, provided only that it is ensured that in the first position liquid which is present in the liquid holder is substantially prevented from passing to the injection needle, and in the second position liquid which is present in the liquid holder is allowed to pass to the injection needle. It is preferable for the first sealing element to form part of the needle mount, for reasons of ease of assembly.
According to a first preferred embodiment, the first sealing element is positioned upstream of the injection needle, i.e. the first sealing element is located between, on the one hand, the interior of the liquid holder and, on the other hand, the opening of the injection needle, with the result that the liquid coming out of the liquid holder will enter the injection needle. In this case, it is preferable for the sealing element to be at least partially accommodated in the needle mount, so that an assembly advantage is achieved.
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 close to the needle mount, all this in such a manner that the sealing element, in its first position, seals off the opening in the side wall of the injection needle and, in its second position, substantially opens up 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 is in the second position, the liquid which is present in the liquid holder passes to the injection needle via 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 outlet opening of the liquid holder, the second sealing element being made from a resilient sealing material and having a passage for the injection needle.
This further improves the leaktightness of the injection syringe assembly. Moreover, the sealing element reduces the risk of the injection needle, if a so-called retractable injection needle is being used, by accident moving out again through the outlet opening of the liquid holder after it has been retracted into the liquid holder. Th s is because the resilient sealing material of the second sealing element, such as for example silicone rubber, ensures that the passacre for the injection needle is sealed off after the latter has been retracted into the liquid holder.
Since in practice the injection needles are generally made from tubular material which is unwound from large coils, these injection needles are often slightly curved, with the result that after the injection needle has been retracted into the liquid holder it no longer points exactly towards the centre, but rather is inclined towards the wall of the liquid holder. This further minimizes the risk of the injection needle being able to find the passage through the sealing element.
The injection syringe assembly is advantageously designed in such a manner that, after use, the injection needle can be retracted into the liquid holder. This makes it possible to prevent the injection needle from being reused after it has been used once. Retractable injection needles are known per se from the prior art and therefore require no further explanation in the present context. By way of example, the injection needle can be made retractable by virtue of the needle mount of the injection needle and the plunger head of the plunger comprising interacting coupling means which, after use (i.e. after the liquid holder has been emptied) , can be coupled to one another so that the injection needle can be retracted into the liquid holder. According to a preferred embodiment, the assembly according to the invention is designed with a retractable needle as described in NL 1 020 937.
It is preferable for the assembly also to comprise a protective cap which is or can be secured to the liquid holder. This protects the injection needle from damage and contamination and moreover allows the leaktightness to be improved if a prefilled injection syringe is being use .
The person skilled in the art will understand that the member used to fix the first sealing element may be designed in numerous ways, provided only that the intended effect can be achieved. It is particularly preferred for the member to form part of the protective cap, since this reduces the number of components which have to be used. This embodiment also improves the ease of use. A particular advantage of this embodiment is that as long as the protective cap is still on the liquid holder the first sealing element remains in place even if a overpressure is present in the liquid holder.
According to a highly favourable embodiment, the protective cap is releasably coupled to the first sealing element, in such a manner that when the protective cap • is removed the first sealing element is moved into its second position.
As a result, the assembly according to the invention, after removal of the protective cap, is immediately ready for use, with the first sealing element in its second position. This may be advantageous, for example, if it is desired to 'aspirate' .
It is also possible for the injection needle to be sterilized, if the protective cap is suitably designed for this purpose (and for example includes a 'sterilization window'; cf. Fig. 6) while the protective cap is still on the liquid holder and without there being any risk of the sterilization fluid reaching the liquid holder via the injection needle.
The person skilled in the art will readily understand that the protective cap and the first sealing element can be designed in many different ways for this purpose. To this end, the protective cap preferably comprises two or more fingers which can move the first sealing element with the protective cap over a predetermined distance when the protective cap is being removed.
According to a highly expedient embodiment of the injection syringe assembly according to the present invention, the fixing member is designed in the form of an element which is arranged displaceably in the wall of the liquid holder and is preferably in the form of a lip.
The element, which is preferably in the form of a lip, can in this case be actuated from outside the liquid holder.
The liquid holder is advantageously filled with liquid; this results in a prefilled injection syringe assembly. Prefilled injection syringes can be supplied by the producer of the liquid which is to be injected, with a liquid holder which has been filled under controlled conditions. Alternatively, the injection syringes can also be filled a few hours before use, for example in the hospital. It has proven favourable (in particular in the case of prefilled injection syringes supplied by the producer) if the assembly is in any event sterilized after the liquid has been introduced into the liquid holder. This prevents contamination of the assembly according to the invention and therefore allows the assembly to be stored for longer. It goes without saying that, if desired and preferred, it is also possible for a sterilization treatment to be carried out before the assembly is assembled and before the liquid holder is filled. Therefore, it is preferable for the assembly to be double-sterilized.
According to a very advantageous preferred embodiment, the assembly is designed in such a manner that during storage there is no contact between liquid which is present in the liquid holder and the injection needle. This prevents corrosion of the injection needle, on the one hand, and contamination of the liquid present in the liquid holder, on the other hand.
Furthermore, the present invention relates to a needle mount, to a needle mount provided with an injection needle, to a first sealing element, to a protective cap and to a liquid holder which are clearly intended for an injection syringe assembly according to the invention. The needle mount which is provided with the injection needle is preferably siliconized (i.e. coated with a layer of silicones) . This prevents the first sealing element from sticking in a certain position after it has been stored for a prolonged period of time .
The invention will be explained in more detail below with reference to the appended, non-limiting drawing, in which:
Figure 1 shows a diagrammatic cross section through an injection syringe assembly according to the invention;
Figure 2 shows the injection syringe assembly shown in Fig. 1 with the first sealing element located in the second position; Figure 2A shows a perspective view of the needle mount used in Fig. 1 and 2;
Figure 2B shows a perspective view of the first sealing element used in Figures 1 and 2; - Figure 3 shows a diagrammatic cross section through an alternative embodiment of an injection syringe assembly according to the invention in which the needle mount is assembled 'from the rear' ;
- Figure 4 shows the injection syringe assembly shown in
Fig. 3, with the first sealing element located in the second position;
Figure 4A shows a perspective view of the needle mount as used in Figures 3 and 4.
Figure 5 shows a diagrammatic cross section through a further alternative embodiment of the injection syringe assembly according to the invention;
Figure 6 shows a diagrammatic cross section through yet another alternative embodiment of the injection syringe assembly according to the invention;
Figure 7 shows the injection syringe assembly shown in Fig. 6, with the first sealing element located in the second position;
Figures 8 and 9 show a diagrammatic cross section through a further embodiment of the injection syringe assembly, with the first sealing element respectively located in the first and second positions;
Figures 10 and 11 show a diagrammatic cross section through yet another embodiment of the injection syringe assembly, with the protective cap releasably coupled to the first sealing element and with the first sealing element respectively located in the first and second positions;
Figure 12 shows a diagrammatic cross section through an alternative embodiment of the injection syringe assembly according to the invention, which is similar to Fig. 6 but is now provided with a fixing member (20) ;
Figure 13 shows the injection syringe assembly shown in Fig. 12, with the first sealing element located in its second position;
Figure 14 shows a perspective view of the injection syringe assembly shown in Figs. 12 and 13; and
Figures 15 and 16 show alternative embodiments for the injection syringe assembly shown in Fig. 14.
Identical reference symbols denote identical or similar components. For reasons of clarity and simplicity, not all the elements which are usually present are indicated. The member which is used according to the invention to fix the first sealing element (member 20) is specifically shown in Fig. 8, and 10-16. Figs. 1-7 are given to improve understanding of the general action of the injection syringe assembly according to the invention.
Figure 1 shows a partial diagrammatic cross section through an injection syringe assembly 1 according to the invention. The injection syringe assembly 1 comprises a liquid holder 2 with outlet opening 3. In the liquid holder 2 there is a displaceable plunger 4 with a plunger head 5 to which a plunger rod 6 is attached. Furthermore, there is an injection needle 7 (generally made from stainless steel) with needle mount 8, the needle mount 8 being secured in the outlet opening 3 of the liquid holder 2. Furthermore, there is a sealing element 9 which is located in a first position preventing liquid 10 which is present in the liquid holder 2 from passing to the injection needle 7. The sealing element 9 may also adopt a second position, as shown in Figure 2, in which liquid 10 which is present in the liquid holder 2 is allowed to pass to the injection needle 7. The first sealing element 9 forms part of the needle mount 8 and is incorporated therein, positioned 'upstream' of the injection needle 7, i.e. the liquid 10 which is present in the liquid holder 2, during injection, if the first sealing element 9 is in the second position, firstly moves past the first sealing element 9 and only then leaves the injection syringe assembly 1 via the injection needle 7. To allow liquid 10 from liquid holder 2 to reach the entry to 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 off in the first position of the sealing element 9.
The sealing element 9 will preferably be made from a resilient material, such as silicone rubber.
In the embodiment shown, the assembly 1 comprises a second sealing element 12, which is made from a resilient sealing material, such as silicone rubber, and has a passage 13 for the injection needle 7, in the outlet opening 3 of the liquid holder 2. Since the second sealing element 12 is made from a resilient material, the leaktightness of the prefilled injection syringe 1 is improved.
When the' injection syringe assembly shown in Figure 1 is in use, the assembly 1 will firstly be filled with liquid 10, for example with the aid of a suction needle which is known in the prior art. Then, the suction needle will be removed and the injection needle 7 with needle mount 8 will be fitted. Stable securing of the needle mount 8 with injection needle 7 onto the outlet opening 3 of the liquid holder 2 is obtained with the aid of the coupling means 15, which is likewise known from the prior art. The coupling means 15 also contributes to ensuring that the assembly as a whole has a good leaktightness.
When the needle mount 8 with injection needle 7 are being fitted, the sealing element 9 is located in the first position, preventing liquid 10 from passing to the injection needle 7.
During injection of the liquid 10, the plunger head 5 can be moved towards the outlet opening 3 by means of the plunger rod 6, with the result that the sealing element 9 is forced into its second position, so that liquid 10 is allowed to pass to the injection needle 7. The second position of the sealing element 9 is clearly shown in Figure 2. Arrows indicate the direction of flow of the liquid 10 in Fig. 2.
Subsequent topping up with new liquid 10 (with the injection needle 7 then being used as a suction needle) is substantially prevented, since this will cause the sealing element 9 to move back into the
first position (cf. Figure 1), with the result that a sealing action is obtained once again.
After the liquid holder 2 has been emptied, the injection needle 7 can be retracted into the liquid holder 2 by coupling being effected between the needle mount 8 and that end of the plunger head 5 of the plunger 4 which faces the outlet opening 3. For a more detailed explanation of the form of coupling between needle mount 8 and plunger head 5, reference is made to Dutch Patent Application 1 020 937. The retraction of the injection needle 7 into the liquid holder 2 after use is preferably carried out as described in this Dutch Patent Application 1 020 937.
The resilient second sealing element 12 prevents the injection needle 7, after it has been retracted, from being accidentally moved out again through the outlet opening 3 of the liquid holder 2, on account of the passage 13 closing up.
Figure 2A shows a perspective view of the needle mount 8 with injection needle 7 as used in Figures 1 and 2. The opening in the needle mount 8, through which the liquid 10 will pass in the second position of the sealing element 9 (cf. Fig. 2), is denoted by 11.
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 through an alternative embodiment of the assembly 1. In the embodiment shown in Figure 3, the assembly 1 is in the form of a prefilled injection syringe, i.e. the liquid holder 2 has already been filled, for example in the factory, and is supplied in prefilled form. The needle mount 8, needle 7 and ring 14 (cf. discussion of Fig. 6 and 7) are assembled 'from the rear', i.e. via that end of the liquid holder 2 which is remote from the outlet opening 3. The assembly 1 shown in Fig. 3 can therefore be assembled 'from the rear' . The assembly 1 shown in Figure 3 includes a protective cap 16 which is connected to the liquid holder 2 and has to be removed prior to use, for example by being broken off. For this purpose, the injection syringe 1 has a thinner wall at the breaking point, which is denoted by 17 in the
drawing. Alternatively, it is of course possible for the protective cap 16 to be designed such that it can be unscrewed. The injection syringe can be sterilized after assembly and filling.
Figure 3 shows the first sealing element 9 in the first, sealing position. Figure 4 shows the prefilled syringe shown in Figure 3, with the first sealing element 9 in the second position, so that the liquid 10 which is present in the liquid holder 2 can move towards the injection needle 7. Figure 4A shows a perspective view of the needle mount 8 as used in Figures 3 and 4. Arrows indicate the direction of flow as indicated in Figure 4.
The prefilled injection syringe 1 shown in Figures 3 and 4 is easy to produce, assemble and operate. In the event of new liquid 10 being sucked in, the first sealing element will return to the first position and will thereby close off the injection needle.
Figure 5 shows a partial cross section through an alternative embodiment of the injection syringe assembly 1, with the first sealing element 9 at least partially surrounding the injection needle 7 and with the injection needle 7 comprising an opening 19 in its side wall 18 in or close to the needle mount 8, all this in such a manner that the sealing element 9, in its first position, seals off the opening in the side wall 18 of the injection needle 17 (Figure 5) and, in its second position, opens up the opening in the side wall 18 of the injection needle (cf. Figures 6 and 7) . The sealing element 9 can easily slide to and fro over the injection needle 7 in order to adopt its first or second position (for this purpose, a layer of silicones may be applied over the outer side 18 of the needle 7) . In this case, however, the sealing element 9 is designed in such a manner that it is impossible for any liquid 10 to 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, in terms of the positioning of the first sealing element 9, is similar to Figure 5, with the assembly once again in the form of a prefilled injection 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 prefilled, closed state (i.e. with the protective cap 16 still connected to the liquid holder 2) . The sterilization window 21 may be made, for example, from paper or another suitable material which allows the injection needle 7 to be sterilized. After the sterilization operation, the window 21 prevents the injection needle 7 from being contaminated by means of its closing action. In Fig. 7, the first sealing element is located in the second position. Moreover, the protective cap 16 has been removed from the liquid holder 2 in order to allow injection to take place.
After the injection needle 7 has been retracted into the liquid holder 2, the first sealing element 9 performs a similar action to the second sealing element 12 from Figs. 1-2, preventing the injection needle 7 from being able to move back out through the outlet opening 3. Furthermore, a ring 14 made from a hard material is located between the front part of the liquid holder 2 and the first sealing element 9. As soon as the needle 7 is retracted into the liquid holder 2 after the liquid holder 2 has been emptied, the point of the needle 7 will come into contact with the ring 14, with the result that the injection needle 7 is made completely harmless without the need for any additional actions .
As will be explained in more detail below in Figs. 12 and 13, it is also possible for an injection syringe assembly as shown in Figs. 6 and 7 to be provided with a fixing member 20 for fixing the first sealing element 9 in its first position.
Figures 8 and 9 show a diagrammatic cross section through a further embodiment of the injection syringe assembly according to the invention. The removable member 20, which in the embodiment shown forms part of the protective cap 16, by interacting with the ring 14 ensures that the first sealing element 9 is reliably fixed in the first position for as long as the protective cap 16 is secured to the liquid holder 2. In this case, the ring 14 is designed in such a manner that, after the protective cap 16 has been removed and after emptying of the liquid holder 2 has commenced, it will move with the sealing element 9 as the sealing element 9 passes into the second position (Fig. 9) .
Figures 10 and 11 show a diagrammatic cross section through a further embodiment of the injection syringe assembly according to the invention. The member 20, which forms part of the protective cap 16, ensures that when the protective cap 16 is removed the first sealing element is moved into its second position, so that the assembly 1 can aspirate directly. In the embodiment shown, the member 20 is designed in the form of two (or more) fingers which hold the first sealing element 9 in the first position as long as the protective cap 16 is secured to the liquid holder (Fig. 10) . However, as soon as the protective cap 16 is removed (Fig. 11), the fingers of the member 20 pull the first sealing element 9 with the protective cap 16 over a predetermined distance. In the position shown in Fig. 11, the fingers of the member 20 are just coming out of the outlet opening 3 of the liquid holder 2, so that the protective cap 16 can be removed from the liquid holder 2, while the first sealing element 9 remains in the second position.
The syringe shown in Figs. 10 and 11 is suitable in particular for injecting into tissue, such as muscle tissue.
Finally, Figs. 12 - 16 respectively show diagrammatic cross sections
(Figs. 12 and 13) and perspective views (Figs. 14-16) of an injection syringe assembly according to the invention, which assembly 1 is similar to the embodiment shown in Figs. 6 and 7 but is now provided with a fixing member 20.
In the embodiment shown in Figs. 12 - 14, the member 20 is designed in the form of an element arranged displaceably in the wall of the liquid holder 2, which element is preferably in the form of a lip. The fixing member 20 can in this case be actuated from outside the liquid holder 2.
Figure 12 shows the assembly 1 according to the invention, with the first sealing element 9 located in its first position, while Fig. 13 shows the situation in which the protective cap 16 has been removed and the first sealing element 9 has been moved into its second position with the aid of the member 20. It is clearly apparent from Fig. 13 that in the process the first sealing element 9 has been
displaced -in such a manner that the opening 19 in the injection needle 7 has been exposed.
Figure 14 shows • a perspective view of the assembly 1 shown in Fig. 12. As a result of the member 20 being moved from the bottom left of Fig. 14 to the top right, the first sealing element 9 moves into its second position (cf. Fig. 13), in which liquid 10 which is present in the liquid holder 2 is allowed to pass to the injection needle 7.
Figures 15 and 16 show alternative embodiments of Fig. 14. The person skilled in the art will readily understand that the member 20 may also be designed differently, provided only that the first sealing element 9 ' can be fixed in its' first position with' the aid of the member 20.