WO2005011781A1

WO2005011781A1 - Medical needle system

Info

Publication number: WO2005011781A1
Application number: PCT/GB2004/003135
Authority: WO
Inventors: Barry Peter Liversidge
Original assignee: Individual
Current assignee: Individual
Priority date: 2003-07-22
Filing date: 2004-07-20
Publication date: 2005-02-10
Anticipated expiration: 2006-01-22
Also published as: GB0317175D0

Abstract

A medical needle system comprises a carrier (10) having a first cylindrical chamber (11) for the storage of a medical needle and a second cylindrical chamber (12) configured as a vial loader. The two cylindrical chambers (11, 12) of the carrier (10) are disposed side by side with their axes generally parallel. The first cylindrical chamber (11) is closed at one end (13) and has a removable seal (15) to close the open other end (14) in order to seal within the first chamber a medical needle which may be in the form of a safety needle assembly (36). The second cylindrical chamber (12) has an internal wall (17) carrying a needle (18) for penetrating the bung (25) of a vial (23), the needle having a hub (19) to which the forward end (33) of a syringe (29) may be connected.

Description

MEDICAL NEEDLE SYSTEM This invention relates to a medical needle system, primarily for use in performing an injection into a human or animal body, using a syringe which is to be filled from a vial of medicament. When an empty syringe of a conventional design is to be used with a medical needle in order to perform an injection, the first stage of the procedure is to load the syringe with an appropriate quantity of the medicament. This is usually done by attaching a needle to the syringe and then using that needle to puncture a bung in the neck of a vial of the medicament, whereafter the medicament is drawn into the syringe. Following removal of the needle from the bung, the same needle may be used to perform the injection or that needle may be disposed of and a fresh needle used to perform the injection. Either way, there are considerable risks to a clinician or a patient of an accidental needle-stick injury during the overall procedure. A very similar procedure is followed when a syringe is pre-filled with a diluent and the vial contains an active material in a dried form. In this case, the diluent is expressed from the syringe into the vial and when the active material has been dissolved, the drug is drawn up into the syringe. Thus, there are the same risks to the clinician and patient as described above. In order to reduce these risks and facilitate draw-up into a syringe, it is known to employ a so-called vial adapter, which is in the form of a tube having an internal transverse wall carrying a needle communicating with a coupler for a syringe, the sharp end of the needle being wholly encircled at all times by the tube. The tube is adapted to receive a standard vial such that when the vial is pushed into the tube, the needle penetrates the bung of the vial, to a pre-set depth to assist draw-up of the vial content. In use, the syringe is connected to the adapter and the vial is pushed into the tube, whereafter the syringe may be loaded from the vial. Another form of vial adapter has a sliding needle, so that a vial may be received fully in the adapter without the bung being penetrated by the needle, and then the needle is slid forward into the vial as a part of the procedure of connecting the syringe to the vial adapter, pressure being put on the syringe to achieve this. A vial adapter may be re-used for further draw-ups from the same vial but more importantly the sleeve protects a clinician and patient from the possibility of a needle-stick injury, during the syringe draw-up procedure. Nevertheless, the clinician is still exposed to risks subsequent to loading the syringe, when continuing the injection procedure. The present invention aims at improving the common procedure described above of using a vial adapter in association with a vial of medicament, for the loading of a syringe prior to performing an injection of the medicament, further to minimise the risks to a clinician. According to this invention, there is provided a medical needle system comprising a carrier having a first cylindrical chamber for the storage of a medical needle and a second cylindrical chamber configured as a vial loader, the cylindrical chambers of the carrier being disposed side by side with their axes generally parallel. It will be appreciated that the performance of an injection may be much simplified by using the medical needle system of this invention. The carrier performs the combined functions of (a) holding a medical needle until it is to be used, (b) assisting the connection of the needle to a syringe to perform the injection, and (c) as a vial loader for use with a vial of medicament from which the syringe is to be loaded, before being connected to the held needle. Further, the carrier may also hold a used needle to facilitate the disposal thereof. The carrier thus makes the procedure of giving an injection much easier to perform as it provides in a single convenient package the two components which a clinician needs to undertake the required procedure using known asceptic techniques and minimises the risk to the clinician and the patient. Most preferably, the first cylindrical chamber is closed at one end and has a removable seal at the other end, the chamber being pre-loaded during manufacture with a medical needle of a suitable form for the intended procedure. The chamber should be loaded under sterile conditions so that the seal may maintain the those conditions as well as serving as a tamper-evident seal, to provide assurance that the needle is new and has not been contaminated. By contrast, the second cylindrical chamber having the vial loader must be open at both ends in order to permit the insertion of a vial into one end and the connection of a syringe to the loader, from the other end. However, both ends of the vial loader should be closed during manufacture with removable seals, again to maintain sterile conditions for the vial loader and to provide assurance that when the loader is to be used, it is free from contamination. In an alternative arrangement, the vial loader may have a vial containing a medicament connected thereto but not sufficiently inserted into the chamber for the needle of the vial loader to penetrate the bung of the vial. The vial may be secured in this position for example by a removable tape, which preferably is in the form of a tamper-evident sterile seal. When the needle system is to be used, the tamper-evident seal may be broken and the vial then pushed further into the second chamber to permit loading of a syringe connected to the other end of the vial loader, following removal of the seal at that other end. The entire needle system could be contained in a complete sterile pack, so ensuring the integrity of the system, as manufactured, until required for use. Alternatively, it could be contained in a simpler but tamper-evident pack, such as a blister pack, with reliance being placed on the chamber seals to ensure sterility for the components. Preferably, the needle is separately sheathed, to protect the sharp end of the needle from accidental damage during handling of the needle system. It would be possible for the needle contained within the first cylindrical chamber to be held at its hub end by the chamber, with the sharp end of the needle furthest into the chamber and the seal extending over the open end of the chamber wholly to enclose the needle in the chamber. Preferably, the sheath of the needle is a close fit within the chamber, in order to hold the needle centrally within the chamber and so to facilitate engagement of the needle with a syringe while the needle is still in the chamber. A further possibility is for a suitable design of safety needle to be contained within the first chamber such that the needle is protected both when in the chamber and subsequently when connected to a syringe, other than when the needle is being used actually to penetrate a body. With all of these possibilities, the needle should be connected to a prepared syringe while the needle is still within the first chamber, simply by pushing or screwing the connector of the syringe into the hub of the needle, exposed by removal of the seal from the first chamber. In the case of a screw- type connector, the needle must be held against rotation with respect to the first chamber so long as the needle remains in that chamber. By way of example only, one specific embodiment of needle handling system of this invention will now be described in detail, reference being made to the accompanying drawings in which:- Figure 1 is a perspective view of the system together with a vial and a syringe; Figure 2 is a partial axial section through the arrangement of Figure 1 ; Figure 3 is similar to Figure 2 but showing both the syringe and vial connected to the vial loader; Figure 4 again is similar to Figure 2 but shows the loaded syringe inserted into the first chamber for connection with a contained needle; and Figure 5 shows the syringe connected to a safety needle assembly ready for use to perform an injection. Referring initially to Figure 1, the medical needle system comprises a carrier 10 defining a first cylindrical chamber 11 and a second cylindrical chamber 12, the two chambers being disposed side by side and with their axes essentially parallel. The first chamber 11 is closed at one end 13 and open at its other end 14, whereas both ends of the second cylindrical chamber 12 are open. Figure 1 shows the system ready for use; in this condition, there is still a removable seal 15 extending over the open end 14 of the first chamber, but seals (not shown) have already been removed from the two ends of the second chamber 12. Such seals typically may be of a metallised foil, heat-sealed to the respective open ends of the first and second chambers. Within the second cylindrical chamber, there is an internal wall 17 of a generally conical form, that internal wall connecting to the cylindrical chamber at one end thereof. Mounted within that internal wall is a needle 18 having a taper-fit hub 19, the hub being locked in position within the internal wall by a rib 20 on the hub interengaging a groove formed within the internal wall 17. As shown, a spacer 21 is arranged between the internal wall 17 and the needle 18, to hold the needle stably on the axis of the second cylindrical chamber. Also shown in the drawings is a conventional vial 23, typically of glass and having a neck 24 fitted with a penetrable bung 25, held in position by a swaged metal ring 26. The central region 27 of the bung is normally covered by a sterile seal (not shown) which is removed immediately before use. The needle system and vial are intended for use with an entirely conventional medical syringe such as that shown at 29, and having a main cylindrical body 30 within which is a piston 31 connected to a plunger 32, the body having at its forward end 33 a taper-fit spigot 34. The syringe forms no part of this invention and as such a syringe is well known and understood in the art, it will not be described in further detail here. Contained within the first chamber 11 is a safety needle assembly 36 (Figure 5). The design of that safety needle does not form a part of the present invention but includes a needle (not shown) having a taper-fit hub (also not shown) held within an outer sleeve 37 within which the needle is slidable so as to project from the end of the sleeve when required for use. The sleeve itself is a close sliding fit within the first cylindrical chamber and is held therein until required for use by the seal 15. In use, the seals (not shown) are removed from the two ends of the second cylindrical chamber (Figure 2) and the taper-fit spigot 34 of the syringe 29 is pushed into engagement with the hub 19 of the needle 18 within the second chamber. The vial has its seal removed and the central region 27 of the bung 25 cleaned and sterilised as appropriate in accordance with well known procedures before the vial is pushed into the second sleeve so that the needle 18 penetrates the bung and communicates with the interior of the vial (Figure 3). When completed, the syringe may be loaded with an appropriate quantity of medicament from the vial. The syringe is then removed from the hub 19 within the second chamber by applying a twisting action to the syringe. The seal 15 is removed from the first chamber 11 and the taper-fit spigot 34 of the syringe is pushed into engagement with the hub (not shown) of the needle assembly contained within the first chamber (Figure 4). During this, the vial may remain within the second chamber. Once an adequate connection has been achieved between the syringe and the needle assembly, the syringe 29 and needle assembly 36 may together be drawn out of the first chamber and used to perform the required medical injection. After completion of the injection, the needle assembly may be reinserted into the first chamber, for disposal. As the needle is wholly contained within the safety sleeve 37, which is preferably locked against withdrawal from the needle to prevent re-use, this is a safe procedure for a clinician. Following that, the syringe may be twisted away from the safety needle assembly or may be left connected thereto and the entire assembly disposed of in a suitable manner.

Claims

1. A medical needle system comprising a carrier having a first cylindrical chamber for the storage of a medical needle and a second cylindrical chamber configured as a vial loader, the cylindrical chambers of the carrier being disposed side by side with their axes generally parallel.

2. A medical needle system according to claim 1, wherein the first cylindrical chamber is closed at one end and has a removable seal provided to close the other end thereof.

3. A medical needle system according to claim 2, wherein a medical needle is stored within the first cylindrical chamber and is enclosed therein by means of the removable seal.

4. A medical needle system according to claim 3, wherein the medical needle contained within the first cylindrical chamber is provided with a protective sheath.

5. A medical needle system according to claim 3 or claim 4, wherein the needle contained within the first cylindrical chamber includes a mounting hub, the open other end of the first cylindrical chamber being configured to hold the mounting hub of the needle.

6. A medical needle system according to claim 3, wherein the needle contained within the first cylindrical chamber is in the form of a safety needle assembly.

7. A medical needle system according to claim 6, wherein the safety needle assembly includes an external sleeve which is a close sliding fit within the first cylindrical chamber.

8. A medical needle system according to any of the preceding claims, wherein the second cylindrical chamber is open at both ends whereby a vial may be inserted into one end of the chamber and the forward end of a syringe may be inserted into the other end of the chamber to allow communication between the vial and the syringe.

9. A medical needle system according to claim 8, wherein removable seals are provided over both open ends of the second cylindrical chamber.

10. A medical needle system according to claim 8 or claim 9, wherein there is an internal wall within the second cylindrical chamber, a needle having a hub being mounted on that wall for penetration of a bung of a vial inserted into one end of the chamber and for connection to a syringe inserted into the other end of the chamber.

11. A medical needle system according to claim 10, wherein the internal wall is of conical profile, and the hub of the needle locates and is held internally within the internal wall.

12. The combination of a medical needle system according to any claims 1 to 9 and in which there is provided an internal transverse wall within the second cylindrical chamber, a needle having a hub being mounted on the transverse wall, and a vial of medicament located and held in the second cylindrical chamber at such a position that the needle within the second chamber does not penetrate the bung of the vial.

13. The combination of claim 12, wherein a removable seal is arranged to hold the vial in said position with respect to the second chamber, removal of the seal allowing movement of the vial with respect to the internal wall so that the needle penetrates the bung of the vial.

14. The combination of claim 12 or claim 13, wherein the seal is in the form of a tamper-evident seal.