WO2003086513A1

WO2003086513A1 - Suction and injection assembly

Info

Publication number: WO2003086513A1
Application number: PCT/NL2003/000278
Authority: WO
Inventors: Bjørn Olaf GOOSSENS; Jan Hendrik Lucas
Original assignee: Medical Patents Ltd.
Priority date: 2002-04-16
Filing date: 2003-04-11
Publication date: 2003-10-23
Also published as: AU2003224501A1; NL1021132C1

Abstract

The present invention relates to a suction and injection assembly (1) at least comprising: a liquid holder (2) with an outlet opening (3); an injection needle (10, 12) with a needle mount (11, 13); and a suction needle (5) with a needle mount (14) which is secured to or in the outlet opening (3) of the liquid holder (2); in which assembly the suction needle (5) can be at least partially broken off at a breaking point (7), all this in such a manner that the breaking point (7), after the suction needle (5) has been at least partially broken off, forms a collar (9) to which the injection needle (10, 12) can be secured.

Description

Short title: Suction and injection assembly

The present invention relates to a suction and injection assembly, at least comprising:

- a liquid holder with an outlet opening;

- an injection needle with a needle mount; and

- a suction needle with suction opening, which suction needle is secured to or in the outlet opening of the liquid holder.

The use of a suction needle is known in medical technology. The use of a suction needle has a number of significant advantages. The suction needle selected may be a needle with a relatively large diameter, so that the liquid holder can be filled with a liquid quickly. Moreover, if, for example, two liquids with different densities are to be injected, these two liquids - on account of the presence of the relatively large diameter of the suction needle, can easily be mixed in the liquid holder using relatively little force.

The needle is often used to puncture a septum in a medical vial, which may cause damage to the needle point and soiling of the outer side of the needle, which is, of course, undesirable for an injection needle; for a suction needle, this is unimportant, since it is removed after use. In the case of glass ampoules or vials which are opened by breaking off a small glass cap, there is a risk that the needle will be damaged when it is sucking up the liquid as a result of the needle coming into contact with the wall or base of the ampoule or vial. Also, an injection needle may have a shape which is unsuitable for sucking up liquid from a medical vial, for example because it is too short. The use of a separate suction needle ensures that an undamaged and sterile injection needle can always be used for injection into a patient. After the suction needle has been used, the suction needle can be replaced by an injection needle for injecting the liquid which has been sucked up.

One drawback of known suction and injection needles is that the suction needle used is a relatively expensive needle. Another drawback is that, if the assembly is not used carefully, the suction needle may be used a second time, which may cause contamination if it is not cleaned in the interim. It will be clear that this is highly undesirable.

It is an object of the present invention to provide a suction and injection assembly which avoids one or more of the above problems. Furthermore, it is an object of the present invention to provide a suction and injection assembly having a simpler structure, so that its production costs can be reduced. It is also an object of the invention to provide an injection assembly which is easier to use.

To this end, the present invention provides a suction and injection assembly according to the preamble, in which the suction needle can be broken off at a breaking point, all this in such a manner that the breaking point, after the suction needle has been broken off, forms a collar to which the injection needle can be secured.

According to the present invention, the term "breaking point" is also to be understood as meaning a breaking zone, provided only that it is ensured that, after the suction needle has been broken off in a positionally defined location, a collar to which an injection needle can be secured is formed.

The suction and injection assembly according to the present invention is particularly simple and therefore inexpensive to produce and assemble. Moreover, there is no need to produce a separate - generally expensive - suction needle.

A further advantage of the invention is that when it is used the user has to carry out fewer actions and, moreover, the risk of mistakes, soiling and/or contamination is minimized.

A particular advantage of the assembly according to the invention is that defined breaking at a positionally defined position is made possible, which leads to reliable and stable coupling when the injection needle is fitted.

Therefore, after the suction needle has been used, it is broken off, resulting in the formation of a collar to which a suitable injection needle can be fitted for injection of liquid which has been sucked up using the suction needle. The suction needle which has been broken off can and generally will be designed in such a way that, after it has been broken off, it can no longer be fitted to another injection syringe. The suction needle can therefore no longer be reused, which prevents mistakes from being made.

The suction needle can be secured to or in the outlet opening of the liquid holder in a variety of ways. However, it will generally and preferably be secured through the liquid holder and the suction needle being formed as a single part, which offers advantages in terms of production engineering.

A suitable injection needle, such as an injection needle which is provided with a standard needle mount, can be secured to the collar which has been formed as a result of the suction needle being broken off. The collar which is to be obtained has a predetermined dimension resulting from the positionally defined location of the breaking point or zone.

Another additional advantage of the suction and injection assembly according to the invention is that while the liquid is being sucked up the plunger can be moved to and fro as often as required for mixing, for example, without coupling occurring the plunger and other components, as in the case of a known retractable injection needle which is also used to suck up liquid.

Incidentally, it should be noted that CH 412 204 describes an injection syringe with a needle which can be broken or cut off and in which, after it has been broken or cut off, a cone to which an injection needle can be attached is obtained. However, CH 412 204 neither describes nor suggests the use of a suction and injection assembly in accordance with the present invention. By contrast, CH 412 204 describes an injection syringe with is provided with what is described as an "instillation tube" (Instillationsrohr) , i.e. a tube for introducing a liquid into a body cavity; it will be clear that an "instillation tube" of this type is quite different from a suction needle.

Furthermore, breaking off the "instillation tube" described in CH 412 204 does not make use of a clear, positionally defined breaking point or zone, and consequently stabe coupling of the injection needle cannot be ensured.

According to a preferred embodiment of the suction and injection assembly according to the invention, the suction needle is made from plastic, preferably polypropylene. It has been found that if the suction needle is made from plastic, the risk of small splinters of plastic forming when the suction needle is broken off is very low. Moreover, making the suction needle from plastic results in a further cost saving.

Furthermore, it is preferable for the suction needle to be made from a transparent material. This provides a good view of the liquid which is present in the suction needle in use and, moreover, enables the moment at which the suction needle is broken off to be selected in such a manner that the suction needle no longer contains any liquid.

The person skilled in the art will understand that the suction and injection assembly can be designed in various ways in order to ensure that the suction needle can be broken off at a breaking point or zone. According to a preferred embodiment, for this purpose the suction needle has a thinner wall at the breaking point.

After the suction needle has been broken off, a collar to which the injection needle can be coupled in a stable way is formed. The collar which is formed will generally be substantially annular. However, the person skilled in the art will understand that the collar may also have a different contour, provided only that it is possible to ensure stable coupling to the injection needle.

The suction needle advantageously comprises a protective cap which can be removed prior to use. This protective cap may, for example, be designed in the form of a sleeve or the like and is used to prevent the user from injuring himself on the suction needle. Furthermore, the protective cap prevents the suction needle from breaking off prematurely or being damaged or contaminated prior to use. The protective cap also prevents the suction needle from puncturing the packaging, if present. It should be noted that it is not per se necessary to use packaging for the suction and injection assembly according to the invention if the protective cap is used.

According to a further embodiment of the invention, the suction and injection assembly also comprises an injection needle which is provided with a needle mount, which needle mount is suitable for coupling to the collar.

The coupling of the injection needle can be carried out in various ways, as known in the prior art, for example using a screw thread ( ^xluer lock') or a clamp fit.

According to a particularly advantageous preferred embodiment of the suction and injection assembly according to the invention, the injection needle is a needle which, when it has been coupled to the collar, can be retracted into the liquid holder. This makes it possible to prevent the user from injuring himself on the injection needle after the injection needle has been used. Furthermore, this prevents the injection needle from being reused (with the associated risk of infection to a second user) .

A particularly favourable aspect of this embodiment according to the present invention is therefore that the suction needle can only be used for suction once and that, after the suction needle has been broken off and the injection needle has been fitted, only one injection can be carried out. This therefore results in a very safe method of injection, with the risk of injury and mistakes being substantially minimized.

Retractable injection needles are . well known in the specialist field. However, it is particularly preferable to use a retractable injection needle as described in EP-B 0 360 313 in the name of APIS Medical B.V.

According to a highly advantageous preferred embodiment of the suction and injection assembly according to the invention, the suction opening of the suction needle is located at a distance from that end of the suction needle which is remote from the outlet opening.

It has been found that if the suction needle is pushed through a septum, for example, there are problems if the end of the suction needle is of hollow design. If the suction opening of the suction needle is positioned at a distance from the end, it is easier to puncture a septum, for example, since the end is now designed to be solid and therefore stronger. The person skilled in the^' art will understand that there may also be more suction openings .

To make puncturing with the suction needle even easier, it is preferable for that end of the suction needle which is remote from the outlet opening to be of pointed design.

The person skilled in the art will understand what pointed' means in this context; for this purpose, the end of the suction needle preferably forms an angle of less than 45°, more preferably less than 30°.

The suction needle advantageously comprises an outwardly directed thickened portion, preferably in the form of an encircling flange, in the vicinity of its end which is remote from the outlet opening. This makes it possible, for example, to obtain a ^positioning ring' , by means of which the suction needle can be positioned accurately on a container (for example an ampoule or vial)^' containing liquid which is to be sucked up, it being possible for the suction opening to be positioned in the container in such a manner that the container holding the liquid to be sucked up can be sucked empty.

The person skilled in the art will readily understand that the thickened portion does not necessarily have to be in the form of an encircling flange, but rather may be of any suitable form, provided only that it is possible to provide positioning which is suitable for suction.

The present invention also relates to a suction needle which is clearly intended for a suction and injection assembly according to the invention.

The suction needle may be made from any suitable material, for example from plastic or metal. As has already been mentioned above, it is preferable for the suction needle to be made from plastic, preferably polypropylene.

Furthermore, the present invention relates to an injection needle, having a needle mount, which needle mount is suitable for coupling to the collar and which injection needle is clearly intended for a suction and injection assembly according to the invention.

The needle of the injection needle is generally made from metal; the needle mount may, for example, be made from plastic.

Furthermore, the invention relates to a liquid holder with a suction needle which can be broken off attached to it, clearly intended for a suction and injection assembly according to the present invention.

Finally, the invention relates to a method for filling an injection syringe and making it ready for injection using the assembly according to the invention, which method comprises the steps of: - sucking up liquid via the suction opening of the suction needle, with the result that the liquid holder is at least partially filled;

- breaking off the suction needle at a positionally defined location at the breaking point, so as to form a collar at a predetermined position; and

- securing the injection needle to the collar.

The suction and injection assembly according to 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 embodiment of a suction and injection assembly according to the invention; Figure 2 shows a diagrammatic cross section through the suction and injection assembly shown in Figure 1 provided with a protective cap;

Figure 3 shows a diagrammatic cross section through the suction and injection assembly shown in

Figure 1, in which the suction needle has been broken off;

Figure 4 shows a diagrammatic cross section through the suction and injection assembly shown in Figure 3 to which an injection needle has been fitted; Figure 5 shows a diagrammatic cross section through the suction and injection assembly shown in Figure 3 in which the injection needle is of the retractable type; and

Figures 6a-c show a partial cross section through a suction and injection assembly according to the invention with an alternative suction needle.

In Figure 1, 1 diagrammatically indicates an embodiment of the suction and injection assembly according to the invention, partly in cross section. The assembly 1 comprises a liquid holder 2 with an outlet opening 3, a plunger 4 (with plunger head 14 and plunger rod 15) which can be displaced inside the liquid holder 2, and a suction needle 5, which is secured to or in the outlet opening 3 of the liquid holder 2. The suction needle 5 may be of any suitable length. In the embodiment shown, the liquid holder 2 and the suction needle 5 form a single unit and are made from transplant plastic.

The suction needle 5 comprises a suction opening 6 at the end which is remote from the outlet opening 3.

The suction needle 5 also includes a breaking point or zone 7 where the suction needle 5 can be broken off unambiguously and in a positionally defined position (on account of the clearly defined position of the breaking point 7) . For this purpose, the suction needle 5 is provided with what are known as breaking wings 23, which make it easier to break off the suction needle 5. Obviously, it is also possible for other breaking means to be used instead of the wing-like breaking wings 23.

Figure 2 shows the suction and injection assembly shown in Figure 1 in which the suction needle 5 comprises a protective cap 8 which can be removed before the assembly 1 is used.

Figure 3 shows the suction and injection assembly shown in Figure 1 in which the suction needle has been broken off at the breaking point 7, with the result that an annular collar 9, to which an injection needle which is yet to be discussed (cf. Figures 4 and 5) can be secured, optionally removably, is formed. The person skilled in the art will understand that the collar 9 will generally be of substantially circular design (for example in the form of a standard cone which is suitable for coupling to injection needles) . However, the collar 9 may also be of a shape other than circular if desired.

Figure 4 shows the suction and injection assembly shown in Figure 3, in which an injection needle 10 with needle mount 11 has been coupled to the collar 9 which has been produced as a result of the part (not shown) of the suction needle 5 being broken off. The injection needle used may, for example, be a standard injection needle. Furthermore, Figure 5 shows a suction and injection assembly as shown in Figure 3 to which, as an alternative to a standard injection needle 10 as shown in Figure 4, a retractable injection needle 12 with needle mount 13 has been coupled. A retractable needle of this type is known per se from the specialist field and is described, inter alia, in EP B 0 360 313. In the embodiment shown, the coupling means 17 connected to the needle mount 13 - after the liquid 16 has been injected - can be coupled to the plunger head 14 of the plunger 4, with the result that the needle 12 can be retracted into the liquid holder 2.

When the suction and injection assembly according to the invention is being used, the protective cap 8 shown in Figure 2, if present, is removed, after which a quantity of liquid can be sucked up via the suction opening 6 with the aid of the suction needle 5. Since the suction needle 5 has a relatively large diameter (compared to the diameter of the injection opening of an injection needle) , the liquid holder 2 can be filled quickly. While liquid is being sucked up, the plunger 4 can be moved to and fro as often as required in order to suitably mix the liquid. After a suitable quantity of liquid has been sucked up into the liquid holder 2, part of the suction needle 5 is broken off at breaking point 7 (if desired using the breaking wings 23) , with the result that an annular collar 9 (cf. Figure 3) is obtained. Then, if desired, a standard injection needle 10

(Figure 4) or a retractable injection needle 12 (Figure 5) can be fitted to this annular collar 9. The injection needles 10 and

12 have a smaller diameter than the suction needle 5.

Since the suction needle 5 can be broken off unambiquously and in a positionally defined position (at a position which is predefined during production of the suction needle) at the breaking point or breaking zone 7, it is possible to provide stable and reliable coupling of the injection needles 10, 12.

After the injection needle 10 or the safe, retractable injection needle 12 has been used, it can then be removed or retracted. Finally, Figures 6a-c show an alternative embodiment of the suction needle 5. Figure 6a represents a partial cross section through the section needle 5, suction openings 6 being located at a distance from that end 18 of the suction needle 5 which is remote from the outlet opening 3. The end 18 is in this case of pointed and solid design, so that it can puncture a septum 21, for example, of the vial 22 shown in Figure 6a more easily.

Fig. 6a also shows that the suction needle 5 comprises an outwardly directed thickened portion, in the embodiment shown in the form of an encircling flange 20. The flange 20 ensures that the suction openings 6 - during suction - can be positioned at a defined, unambiguous position.

Fig. 6b shows a diagrammatic cross-sectional plan view of the suction needle 5 as shown in Figure 6a. As is clearly apparent, the suction needle 5, in the embodiment shown, comprises two opposite suction openings 6. Obviously, there may also be more than two suction openings 6.

Finally, Fig. 6c also shows a partially diagrammatic side view - in this case not in section - of the suction needle 5 as shown in Fig. 6a. One of the suction openings 6 is clearly visible in this figure.

Claims

1. Suction and injection assembly (1), at least comprising: - a liquid holder (2) with an outlet opening (3) ;

- an injection needle (10, 12) with a needle mount (11, 13) ; and

- a suction needle (5) with suction opening (6), which suction needle (5) is secured to or in the outlet opening (3) of the liquid holder (2) ; in which assembly the suction needle (5) can be broken off at a breaking point (7) , all this in such a manner that the breaking point (7) , after the suction needle (5) has been broken off, forms a collar (9) to which the injection needle (10, 12) can be secured.

2. Suction and injection assembly according to claim 1, wherein the liquid holder (2) and the suction needle (5) are produced as a single piece.

3. Suction and injection assembly according to claim 1 or 2, wherein the suction needle (5) is made from plastic.

4. Suction and injection assembly according to one or more of the preceding claims, wherein the suction needle (5) has a thinner wall at the breaking point (7) .

5. Suction and injection assembly according to one or more of the preceding claims, wherein the suction needle (5) comprises a protective cap (8) which can be removed before use.

6. Suction and injection assembly according to one or more of the preceding claims, wherein the injection needle (12) is a needle which, when it is coupled to the collar (9) , can be retracted into the liquid holder (2) .

7. Suction and injection assembly according to one or more of the preceding claims, wherein the suction opening (6) of the suction needle (5) is located at a distance from that end (18) of the suction needle (5) which is remote from the outlet opening (3) .

8. Suction and injection assembly according to one or more of the preceding claims, wherein that end (18) of the injection needle (5) which is remote from the outlet opening (3) is of pointed design.

9. Suction and injection assembly according to one or more of the preceding claims, wherein the suction needle (5) , in the vicinity of its end (18) which is remote from the outlet opening (3) , comprises an outwardly directed thickened portion, preferably in the form of an encircling flange (20) .

10. Suction needle (5), clearly intended for a suction and injection assembly (1) according to one or more of the preceding claims 1 - 9.

11. Injection needle (10, 12) having a needle mount (11, 13), which needle mount (11, 13) is suitable for coupling to the collar (9) , and which injection needle is clearly intended for a suction and injection assembly (1) according to one or more of the preceding claims 1 - 9.

12. Liquid holder (2) with a suction needle (5) which can be broken off secured to it, clearly intended for a suction and injection assembly (1) according to one or more of the preceding claims 1 - 9.

13. Method for filling an injection syringe and making it ready for injection using the assembly according to one or more of the preceding claims 1 - 9, which method comprises the steps of:

- sucking up liquid via the suction opening (6) of the suction needle (5) , with the result that the liquid holder (2) is at least partially filled;

- breaking off the suction needle (5) at a positionally defined location at the breaking point (7) , so as to form a collar (9) at a predetermined position; and

- securing the injection needle (10, 12) to the collar (9) .