FR2841789A1 - DEVICE FOR PREPARING A PHARMACEUTICAL OR MEDICINAL PRODUCT, ESPECIALLY INJECTABLE - Google Patents

Abstract

Device for preparing a product, in particular an injectable product, this device comprising a metal container (10) for dissolving and heating the injectable product and a filtering tip (22) intended to be mounted on a syringe and comprising a flat suction head with filter membrane (30) for the suction of the product contained in the container (10).

Description

DEVICE FOR PREPARING A PHARMACEUTICAL PRODUCT

  OR M DICAMENTOUSLY INJECTABLE

  The invention essentially relates to a device for preparing a pharmaceutical or medicinal product, in particular an injectable product, containing an active principle, this device comprising at least one filtering tip intended to be mounted on an injection syringe for the aspiration of the product. The syringe and the filter tip can be enclosed in a sterile blister-type package, comprising a plastic box sealed with a removable cover and containing the syringe and the filter tip, as well as possibly other objects such as a sterile compress, a metal container handling sleeve, etc. A device of this type is described in international application WO 98/51356 of the applicant. In this international application, the filter tip is formed by a cylindrical tubular element for protecting an injection needle, this element comprising at one end a filter formed by a cotton or plastic pad having a determined porosity and allowing to eliminate the impurities contained in the injectable product which is aspirated in the body of the injection syringe. The end of the cylindrical tubular element which comprises the filter is advantageously covered with a protective cap, which is removed to draw into the body of the syringe the

product to inject.

  The object of the present invention is in particular to provide

  improvements to this known device.

  It relates to a sterile and disposable device for preparing a product, in particular an injectable product, this device being usable with an injection syringe with a fixed needle, for example crimped or with a removable needle and further comprising means ensuring filtration. optimal injectable product during its aspiration into the injection syringe. It proposes, for this purpose, a device comprising at least one filter tip intended to be mounted on an injection syringe for the aspiration of the product, this device being characterized in that the filter tip comprises a first tubular fixing part sealed on an end cone of the syringe, an intermediate tubular part intended to receive an injection needle and having an inside diameter smaller than that of the first tubular part and slightly greater than the outside diameter of the needle, and a head open free end suction plate which is provided with a filtering membrane and which has a diameter several times

higher than that of the needle.

  The filter tip according to the present invention has a particular shape which minimizes the volume of air contained in this tip when mounted on an injection syringe, and which thus ensures good suction of the product through the filter membrane. The dimension of this membrane, relatively large compared to the internal diameter of the injection needle, guarantees correct aspiration of a determined quantity of product, before any risk of blockage of the filter by impurities contained in the product. In addition, the manipulations required are limited to mounting the filter tip on the syringe, which is done without touching the injection needle or the filter. This facilitates the correct use of the device according to the invention and reduces the risks of contamination to the

  preparation and / or injection of the product.

  Advantageously, the filtering tip comprises a seal for sealing its end of mounting on the injection syringe, which guarantees that this filtering tip has not already been used before. The filter tip can be mounted on an injection syringe with a crimped needle or on a syringe of the "Luer" cone type with removable needle. According to another characteristic of the invention, the device also comprises a metal container for dissolving and heating the product and the bottom of the metal container comprises a recess having a shape and dimensions corresponding to those of the suction head of the 'filter tip. This characteristic guarantees that it will be possible to aspirate by means of the nozzle filtering the entire product.

contained in the container.

  The invention will be better understood and other characteristics, details and advantages thereof will appear more clearly on reading

  the following description, given by way of example with reference to the drawings

  attached in which: - Figure 1 is an enlarged schematic view in axial section of a device according to the invention; - Figure 2 is an enlarged schematic view of the packaging

of this device.

  The device shown diagrammatically in FIG. 1 comprises a metal container 10 which is advantageously produced by stamping a light metal, for example an aluminum sheet having a thin thickness (typically about 0.2 mm), this container having a bowl shape with a substantially flat bottom with a diameter of

  around 25 to 30 mm, for example.

  It has an upper peripheral rim 12 formed with a

  radial tab 14 for gripping and handling.

  This metal container 10 is intended to receive a product, for example a pharmaceutical or medicinal product, in the form of a powder, which must be dissolved in a small quantity of sterile water which is poured into the container 10. The metallic nature of this This allows it to be placed over a flame or other heat source for the dissolution of the product. A sleeve 16 made of thermally insulating or heat-insulating material, for example a plastic material, is threaded onto the radial tab 14 of the container 10 so that the user can by means of the sleeve 16 hold the container 10 above a flame

  for a sufficient time, without burning your fingers.

  Preferably, the shape of the sleeve 16 is such that it makes it possible to stabilize the container 10 when the latter is placed on a support surface 18 as shown in FIG. 1. It suffices for this that the lower part 20 of the sleeve 16 forms a fulcrum on the surface of

support 18.

  The dissolved product contained in the container 10 is withdrawn from this container by means of an injection syringe of a conventional type, comprising an injection needle which can be either fixed, in particular crimped, or removable. For the suction of the contents of the container 10, a filtering tip 22 is mounted on the syringe for the elimination of any

  solid impurities which would be contained in the product to be injected.

  This filtering tip is tubular in shape and comprises a first cylindrical part 24 for fixing to the conical end part of a syringe, an intermediate cylindrical part 26 which is intended to optionally receive an injection needle, and a flat head d suction 28 whose open free end is provided with a membrane

  filter 30 having a determined porosity.

  The intermediate part 26 has an internal diameter which is very slightly greater than the external diameter of an injection needle, so that this needle can be inserted easily inside the

  cylindrical part 26 of the end piece 22, and is housed therein with very little play.

  The first cylindrical part 24 has a diameter greater than that of the intermediate part 26 and is connected to the latter by a frustoconical part 32, the internal surface 34 of the opposite end of the first part 24 being frustoconical for its sealing attachment on the cone

end of a syringe.

  The flat suction head has an internal diameter several times greater than that of the intermediate part 26 and a very low height, so that the volume of air contained in the filter nozzle 22 mounted on

  a syringe is as small as possible.

  In a particular embodiment, the filter tip has a length of about 20 mm, the outside diameter of the suction head 28 is about 10 mm, the internal diameter of the intermediate part 26 is about 0.5 mm , and the height of the suction head 28 is approximately 1.5 mm. Typically, the filter membrane 20 has a porosity of about 5 to 6 and is made of polyamide, polypropylene or any other suitable plastic material. In a preferred embodiment, the filter tip 22 and the membrane 30 are made of polypropylene and the

  membrane 30 is fixed by welding to the periphery of head 28.

  Advantageously, the bottom 36 of the container 10 has a small central recess 38 whose shape and dimensions correspond substantially to those of the suction head 28, so that the latter can be accommodated in this central recess 38 when the filter tip 22 is oriented perpendicular to the bottom 36 of the container 10. This allows

  the user to aspirate all the liquid contained in the container 10.

  As shown schematically in Figure 2, the container 10 and the filter tip 22 can be packaged in a sterile manner in the same package which comprises a box 40 formed of a thin sheet of relatively rigid plastic, the portion of which upper is closed off by a removable cover 42, sealed or glued to a peripheral rim of the box 40. The latter comprises two compartments 44, 46 one of which contains the container 10 and the other the filtering tip 22 and which are separated by a wall 48 formed by a rib or a recess in the bottom of the box 40, so that the gripping tab 14 of the container 10 can extend above this wall 48 and comes inside from the other compartment 46, possibly covering the filter tip 22. This makes it possible in particular to remove the container 10 from the box 40 by pressing on the free end of the tab 14, which avoids

  touch the inside of the container 10 with your fingers.

  The box 40 can also contain a syringe, a sterile compress and water possibly added with citric or other acid allowing to lower its pH to facilitate the dissolution of the product

to inject.

  Of course, the sleeve 16 is also disposed in the box 42, either by being already mounted on the lug 14 of the container 10, or by being deposited in the compartment 46 of the box 40 and can alternatively

  consist of a protective cap on one end of the syringe.

  The end piece 22 can be closed by at least one seal of impermeable material which seals the first part 24 of the filter end piece 22 and optionally by a seal which covers and protects the membrane.

filter 30.

  As a variant, the filtering tip 22 can be mounted on an injection syringe, and it suffices in this case to cover the filtering membrane 30 with a protective and sealing cap or to arrange the syringe with

  the nozzle in a box which will be sterilized.

  The device according to the invention is easy to use, simple and economical to manufacture and of universal use, insofar as it can be used with any type of injection syringe. The components of this device are for single use and their packaging in the box 40 closed by the cover 42 greatly reduces the risk of contamination during their use. Furthermore, the filter membrane made of plastic has a hydrophobic character and can only be used once, insofar as it often risks being more or less blocked by impurities after aspiration of a first dose of liquid in the container 10, which prohibits in practice a new use of this

filter membrane.

  This device can be used in the following way: When it only comprises a filter tip 22 associated with a plunger syringe, it can be used for the aspiration of a dose of product through the filter membrane 30. Then, the tip 22 is removed from the syringe and the filtered product contained in this syringe can be used in any desired manner, for example by injection if a needle is attached to the syringe. The filter tip 22 can also be used with a syringe provided with a fixed injection needle, for example crimped. In this case, the injection needle is received with a very small clearance in the intermediate part 26 of the filtering tip and the product is drawn into the syringe while being filtered through the membrane 30 and passing through the needle. injection. Simply remove the filter tip 22 from the syringe to be able to

inject the product.

  It is advantageous that the device contained in the sealed packaging 40, which is for single use, is complete and includes the container 10, the filter tip, a syringe and an injection needle, acidified injectable sterile water, a sterile compress and a sleeve for gripping the container, this sleeve possibly being constituted by a protective cap which covers the end of the syringe comprising the plunger. As already indicated, the filter tip can

  whether or not mounted on the syringe inside the packaging.

Claims (9)

  1. Device for preparing a pharmaceutical or medicinal product, this device comprising at least one filter tip (22) intended to be mounted on a syringe for aspirating the product, characterized in that the filter tip (22) comprises a first tubular part (24) for tightly fitting onto an end cone of the syringe, an intermediate tubular part (26) intended to receive an injection needle and having an internal diameter smaller than that of the first tubular part (24 ) and slightly greater than the external diameter of the injection needle and a flat suction head (28) with an open free end provided with a filter membrane (30) having a diameter several   times that of the injection needle.   2. Device according to claim 1, characterized in that the filtering end piece (22) comprises a sealing seal seal   end of attachment to the syringe.   3. Device according to claim 1 or 2, characterized in that it also comprises a metal container (10) usable for dissolving and heating the product and in that the bottom (36) of the container (10) has a recess (38) having a shape and dimensions   corresponding to those of the suction head (28) of the filter nozzle.   4. Device according to claim 3, characterized in that it also comprises a sleeve (16) for gripping and handling the container, this sleeve being intended to engage or hang on a radial tab (14) of the container and being capable of ensuring the stability of the   container (10) placed on a support (18).   5. Device according to claim 3 or 4, characterized in that it is contained in a sterile packaging comprising a box (40) of plastic material comprising a compartment (44) for housing the container (10) and a compartment (46) housing the filter tip (22), these two compartments being separated by a wall (48) above which extends a radial tab (14) of the container (10), the box (40) being   tightly closed with a removable cover (42).   6. Device according to claim 5, characterized in that the   sterile packaging also contains a syringe.   7. Device according to claim 3 or 4, characterized in that it is contained in a sterile packaging comprising a box (40) of plastic material comprising a compartment for housing the container (10), and a compartment for housing the syringe fitted with end cap filter (22).   8. Device according to one of claims 5 to 7, characterized in   that the box (40) also contains sterile injectable acidified water.   9. Device according to one of claims 6 or 7, characterized in   that one end of the syringe is covered with a usable cap   as a sleeve for gripping the container (10).