AU7662998A

AU7662998A - Receptacle for preparing medicines and injection kit containing same and filtering adapter

Info

Publication number: AU7662998A
Application number: AU76629/98A
Authority: AU
Inventors: Elliot Imbert
Original assignee: Individual
Current assignee: Individual
Priority date: 1997-05-12
Filing date: 1998-05-12
Publication date: 1998-12-08
Also published as: CA2290667A1; WO1998051356A1; EP0981382A1

Description

VESSEL FOR THE PREPARATION OF MEDICINES AND INJECTON KIT CONTAINING SUCH A VESSEL AND A SYRINGE WITH FILTERING ADAPTER 5 The invention relates to the field concerning the preparation of injectable active products and medicines, more precisely, when this preparation requires a syringe, an auxiliary preparation vessel, sterile water in the vessel or in a bottle. The water and the other items are sterile and disposable. The use of a filter itself sterile and 10 disposable then enables the injectable product to be purified. The preparation vessel may include a rim to which a cover may be welded to protect the water in the case when the sterile water is placed in the vessel. This set-up and other items such as a post injection buffer, an alcoholized compress, citric or ascorbic acid, 15 constitute a kit set out in a case which is available at pharmacies or in specialized businesses. The preparation may be soluble only in hot water and, consequently, the vessel is made of metal to tolerate the flame. For reasons of cost and ease of manufacture, the vessel is formed by 20 drawing a light metal, for example an aluminium sheet. In order to obtain a good manual grip on the vessel, a large part of the rim of the latter is extended in the form of an approximately triangular lug or tongue, Now, it is very difficult to hold this type of highly heat-conducting metal with bare hands and doing so causes burns 25 when the vessel is heated with a flame for the preparation of the mixture to be injected. Various solutions have been put forward to resolve this problem. For example, the French utility certificate application, published under the number 2722412, recommends that the tongue 30 be covered with poorly heat-conducting material or even that the vessel be surrounded by a cardboard support to which the cover is also fixed. These solutions entail the introduction of additional means which increase the cost of the kit by complicating the manufacture of the spoon without guaranteeing a serious 35 reduction of the risks of burns. Moreover, even if the vessel is made of a poor heat conducting metal or a non-conductor, such as stainless steel, the 2 quantity of metal needed to constitute the holding tongue entails additional cost and increased bulk. In order to resolve the problem raised while maintaining the asepsis of the vessel during the preparation of the active product, 5 the invention proposes an alternative solution without increajng the cost of the kit or complicating the carrying out of the manufacture of the vessel. This solution is based on the use of a plastic element present in the kit which is non-heat conducting and the interior of which is sterile. This element is adapted to the vessel, 10 shaped to provide it with a safe connection in order to serve as holding tongue for grasping with bare hands without fear of being burned. More precisely, the object of the invention is a vessel for preparing medicines and active products to be injected in the shape 15 of a crucible delimited by a rim. The rim presents a projecting part shaped to form a connection between the vessel and a syringe adapter possessing a sterile bore such that the asepsis of the crucible and its thermal insulation are maintained by the use of this adapter as tongue for holding and maintaining the vessel during 20 heating of the crucible made of heat-conducting metal, the heating being necessary for the solubilization of the active product. The syringe adapter may be the sleeve of the needle or the end of the syringe piston head. The invention also relates to a kit for the administration of 25 active products and medicines containing a vessel with the special form indicated above, adapted for its connection to the adapter of the syringe contained in this kit. Advantageously, the syringe is prefilled with sterile and injectable water. In order to improve asepsis, a purification of the product to 30 be injected is ensured by a filter for impurities contained in the kit. Since such purification limits the number and size of the particles aspirated into the syringe, bacterial, fungal and parasitic constituents are not aspirated. This filter is mounted, for example by welding, in the sleeve of the syringe needle in order to allow 35 direct use of the filter during aspiration of the medicine or the active product into the body of the syringe without having to detach the sleeve of the syringe needle for this filtration operation. The sleeve may be covered by a sterile cap to protect the filter. Such an 3 arrangement is particularly suited to fixed needles but may also be used when the needle is removable. In this embodiment, the piston head end is used as the means for holding the metal crucible. Other characteristics and advantages of the invention will S become apparent on detailed reading of the description which follows with reference to the appended figures which respectively represent : - Figure 1, a perspective view of a first example of the embodiment of the vessel according to the invention to achieve the 10 connection between a vessel and a syringe adapter; - Figure 2, a second example of such a vessel; - Figure 3, a third example of a vessel; - Figure 4, a fourth example of this same vessel; -Figure 5, a view of the syringe equipped with a needle sleeve 15 incorporating a filter according to the invention. According to the invention, the syringe adapter made of plastic material and the mixing vess for the product to be administered make it possible, as a result of their being combined by 20 different types of connection, to resolve the problem associated with the thermal conductivity of the material constituting the mixing vessel or with additional costs relating to the use of poorly conducting material. In the different examples of the embodiment illustrated, 25 identical reference numbers designate the same objects. In these examples, the preparation vessel includes a rim but the invention relates equally well to vessels without a rim, i.e. where the edge forming the upper limit of the crucible has no curved portion forming a border of peripheral material. 30 According to a first embodiment illustrated in Figure 1, the vessel 1 consists of a crucible la delimited by a rim 2 to which is welded a cover 3 and a rim extended in the form of a projection 4. This projection 4 may be produced during drawing when the sizing of this edge is performed by cutting. The cutting is then performed 35 except for a portion corresponding to the projection. The rim may then be completely removed, except the portion corresponding to the projection when a rimless vessel is produced.

4 This projection has the form of an approximately rectangular surface of a width predetermined so as to be capable of being inserted into the bore A of the adapter 5 of the syringe needle (not shown) or the piston adapter. In practice, this width is equal to or 5 slightly more than 4 mm or 10 mnm, respectively, depending on whether the adapter is that of the syringe or the piston. So as to be inserted easily but firmly into this bore, this insertion is obtained by ovalisation of the bore which results from manual pressure exerted on the plastic material of which the adapter is constituted. The 10 length of the projections to be determined by the person skilled in the art as a function in particular of the density of the metal used for the vessel in order not to risk the loss of the vessel as a result of uncoupling owing to the weight to be supported. The projection 4 may be oriented with respect to the upper 15 plane of the vessel 1 and inclined to the surface of the rim 2 at an angle varying between plus or minus 30 degrees. The angle is limited so as not to risk disconnection between the adapter and the vessel. In the example illustrated in Figure 2, the extension has the 20 form of a perforated bracket 4' with a circular hole 6, the diameter of which is equal to the external diameter of the adapter 5, near to the collar7 of this adapter. Such a collar is usually formed at the end of the adapter covering the end of the syriige needle, the bore A of the adapter thus forming an obstructed hole designed to 25 protect the syringe, in particular its end. The bracket 4' may be oriented either approximately perpendicular to the upper plane of the vessel I or in this plane as illustrated in Figure 3. In this case, the adapter 5 is oriented perpendicularly to the upper plane of vessel 1. 30 According to another embodiment, such as that shown in Figure 4, the extension is formed by an approximately cylindrical surface 4". The extension is formed initially, in this example, by a plane surface of sufficient dimensions so that the edges 4a and 4b of this surface, once pressed down on each other, form an 35 approximately cylindrical surface, the facing edges 4a and 4b defining a slot F, parallel to the axis of rotation X'X of this surface and of minimal or zero width.

5 The diameter of this cylindrical surface corresponds to the external diameter of the adapter 5 of the syringe needle such that when the adapter 5 is inserted into the space defined by this surface, this adapter is maintained firmly by the cylindrical surface 4". The 5 collar 7 abuts against the circular rim of the cylindrical surface 4" placed on the side of the vessel 1. It is within the competence of the specialist skilled in the art to adapt the known cutting procedures so as to produce the dimensions of optimal extension to obtain a good connection 10 between the vessel and the adapter. In particular, the formation of holes in these projections or the folding of these latter may be achieved with the aid of known procedures. In Figure 5, the syringe 8 equipped with its piston 8, its protective sleeve 9 for needle 10 and its protective end 11 for piston 15 head 8b is shown in more detail The sleeve 9 comprises a filter 12 for filtering the impurities and a cap 13, the interior of which is sterilized to protect the adapter which it covers. This adapter is particularly suited in the case of a fixed needle syringe 10 to filter the dissolved active product taken from vessel 1. The filter is a 20 Nylon@ membrane in the embodiment of the example with a porosity of 5 to 20 pm for good retention of impurities. Such an adapter may also be used with non-fixed needle syringes. The dissolution of the active product is obtained by using sterile water mixed with the active product in the crucible and with 25 the aid of the piston head Sb which is sterile to stir the mixture aseptically for the purpose of dissolution, Then the mixture is heated beneath the crucible after having placed the sleeve 11 round the tongue 4 of the vessel, using it as a handle in order to prevent the user from being burned. 30 The dissolved active product is also taken, in this embodiment, into the syringe through the filtering adapter, once the cap has been removed from the sleeve of the needle 10. In order to lose as little product as possible, the surface of the filter 12 (Figure 5) facing the needle is advantageously inclined in 35 order to fit as close as possible to the surface of the bevelled end of the needle 10. The invention also relates to a kit for the administration of products or medicines containing in particular a mixing vessel, such 6 as that previously described, a conventional syringe equipped with needle and piston adapters, an external filter for the filtration of sterile water. This water may be placed in a separate bottle, in the vessel or in the prefilled syringe. The vessel and the filter placed in 5 the vessel may together be advantageously placed in a sterilizable flexible packing. This combination is designed to be disposable, to prevent infectious contamination and for the removal of impurities. The invention is not limited to the examples of embodiment described and lustrated. For example, it is possible to design 10 several extensions of different or identical forms, for example such as those described above, along the rim of the same vessel so as to be able to optimize the connection between one of these extensions and any type of size of syringe adapter or other adaptable element used in the preparation and injection kIt. 15 Moreover, the filter may be of the filtering or absorbent type. Furthermore, in the case in which the syringe is equipped with a conventional needle adapter, at least one filtering adapter according to the invention may be included in the kit, then fitted to the needle instead of the conventional adapter during the filtration 20 step. 25 30 35

Claims

1.- Vessel for preparing medicines or active products for administration by injection, forming a crucible delimited by a rim, 5 characterized in that the rim (2) possesses an extension (4,4'A) shaped to produce a connection between the vessel (1) and a syringe adapter possessing a sterile bore (5) such that the asepsis of the crucible and its thermal insulation are maintained by using this adapter as tongue for holding and maintaining the vessel (1) when 10 the crucible made of heat-conducting metal is heated, the heating being necessary to dissolve the active product.

2.- Vessel according to Claim 1, characterized in that the extension is a projection (4) which has the form of an approximately rectangular surface of a width corresponding to the 15 internal diameter of the bore (A).of the adapter (5) of the syringe so that the projection can be inserted into the bore easily but firmly.

3.- Vessel according to claim 2, characterized in that the width of the projection is greater than the diameter of the bore (A) of the adapter (5) 20 4. Vessel according to Claim 3, characterized in that the projection (4) is inserted by ovalization into the bore (A) of the adapter (5).

5.- Vessel according to any one of the preceding Claims, characterized in that the projection (4) is oriented with respect to 25 the upper plane of the vessel (1) by an angle varying between about plus or minus 30 degrees.

6.- Vessel according to any one of the preceding Claims, characterized in that the syringe adapter is selected between the sleeve of the needle and the piston adapter. 30 7.- Vessel according to Claim 1, characterize in that the extension has the form of a perforated bracket (4') with a circular hole (6) the diameter of which is approximately equal to the external diameter of the adapter (5) at the height of the collar (7) of this adapter. 35 8.- Vessel according to claim 7, characterized in that the bracket (4') is oriented approximately perpendicular to the upper plane of the vessel (1). 8

9.- Vessel according to Claim 7, characterized in that the bracket (4') is oriented approximately parallel to the upper plane of the vessel (1). 10,- Vessel according to Claim 1, characterized in that the 5 extension is formed by an approximately cylindrical surface(4"), the opposing edges of which (4a,4b) define a slot (F).

11.- Vessel according to claim 10, characterized in that the diameter of this cylindrical surface (4') corresponds to the external diameter of the adapter (5) of the syringe needle. 10 12.- Vessel according to Claim 11, characterized in that the collar (7) abuts against the circular rim of the cylindrical surface (4") placed on the side of the vessel (1).

13.- Vessel according to Claim 1, characterized in that several extensions are arranged along the rim (2) of the same vessel (1) so .15 as to enable a connection tobe made between one of these extensions and a syringe adapter (5) or other adaptable element of any size utilized in a preparation and injection kit.

14.- Preparation and injection kit for medicines and active products containing in particular a mixing vessel according to any 20 one of the preceding Claims and a syringe equipped with a needle sleeve and a piston adapter.

15.- Kit according to Claim 14, characterized in that a filter of impurities (12):is mounted in the sleeve (9) of the syinge (8) to filter the medicine or the active product directly into the body of the 25 syringe prior to their injection.

16.- Kit according to Claim 14 in the case where the syringe is equipped with a conventional adapter in which is placed at least one filter adapter according to Claim 15 to be fitted to the syringe needle instead of said conventional adapter during filtration. 30 17.- Kit according to Claim 15, characterized in that the sleeve (9) is covered by a cap (13), the interior of which is sterile to protect the filter (12) which it covers.

18.- Kit according to any one of the Claims 15 to 17, characterized in that the surface of the filter (12) facing the needle 35 (10) is inclined in order to fit snugly to the bevelled end surface of the needle (10).

19.- Kit according to any one of the Caims 14 to 18, characterized in that the syringe is prefilled with sterile water.