WO2003043564A1

WO2003043564A1 - Transferring device

Info

Publication number: WO2003043564A1
Application number: PCT/IB2002/004837
Authority: WO
Inventors: Mauro Mantovani; Massimo Soffritti
Original assignee: Aries Srl
Current assignee: Aries Srl
Priority date: 2001-11-22
Filing date: 2002-11-20
Publication date: 2003-05-30
Anticipated expiration: 2004-05-22
Also published as: AU2002366012A1; EP1455729A1; ITMO20010226A1; ITMO20010226A0

Abstract

An apparatus for diluting and transferring a liquid means, comprising a transit means (10, 24, 49, 52, 57) of said liquid means for delivering to and/or drawing from a container said liquid means, a passage means (11, 27, 54, 56) arranged to enable the passage of gas between said container and an external environment, casing means (2, 3, 8, 9) containing a gas-filtering means (7) arranged to filter said gas and provided with an opening means (34) for said gas, characterized in that said opening means (34) is made in such a way as not to protrude from said casing means (2, 3, 8, 9).

Description

TRANSFERRING DEVICE

This invention concerns an apparatus for transferring pharmaceuticals the preparation of which requires the dilution of a powder preparation. To make up pharmaceuticals, in particular antibiotic and chemotherapeutic pharmaceuticals, lyophilised pharmaceuticals or pharmaceuticals in powder form are diluted in the prior art by means of a diluting liquid and the preparation thereby obtained is subsequently transferred into suitable containers, for example bags, from which said preparation is drawn during administration .

Said preparation is made up by injecting the diluting liquid by means of a syringe into a bottle containing the lyophilised pharmaceutical or pharmaceutical in powder form, gently shaking the bottle to enable perfect dilution and subsequently drawing by means of the syringe the preparation thereby obtained to transfer it into one of the aforementioned containers . The pharmaceuticals must be handled in secure conditions to prevent accidental contact with the operator's skin or eyes.

As toxic gases that are harmful for the operator can be generated when the pharmaceuticals are diluted the solutions that can be obtained with these pharmaceuticals are made up by operating underneath an aspiration hood. This causes considerable discomfort to the operator because his possibility of moving his hands is greatly hampered. A further difficulty that is encountered when obtaining preparations obtained from pharmaceuticals of the type previously described consists in the fact that said pharmaceuticals, particularly chemotherapeutic pharmaceuticals, are extremely costly and it is therefore necessary to draw the entire contents from the bottles inside which they have been mixed with the diluting liquid. International patent application WO 00/07539 discloses a device for diluting pharmaceuticals intended for injection into a patient, comprising a body provided with a top portion suitable for being coupled with a syringe and a bottom portion configured in such a way that it can receive a phial containing the medicine, said phial being axially aligned on said syringe.

Said body furthermore comprises an intermediate portion that connects the top portion and the bottom portion, provided with a central opening that constitutes a passage for the transfer of the fluid between the syringe and the bottle. The intermediate portion furthermore comprises a tip that is internally provided with a hollow conduit that extends downwards from the bottom of the central opening for a distance that is sufficient to enable the bottom end of the tip to perforate a closing seal, which shuts the bottle that is associated with the bottom portion of the device and to penetrate inside the latter. When the tip has perforated the closing seal the hollow conduit enables air to enter inside the bottle in such a way that the pressure inside the bottle is the same as the atmospheric pressure outside the bottle.

The device may furthermore comprise a filtering element associated with the opening that connects the bottle and the syringe, said filtering element being suitable for retaining pharmaceutical particles with a large diameter, which may obstruct the syringe.

One disadvantage of the above described device consists of the fact that it is rather cumbersome and is therefore difficult for the operator to handle.

Said difficulty is particularly clear when dilution and transfer of the pharmaceutical occur at a preparation station located underneath an aspiration hood that obstructs the movement of the hands of said operator. Another defect of the device disclosed in patent application WO 00/07539 consists of the fact that any harmful, toxic gases that are produced during dilution of the pharmaceutical leave the bottle through the hollow conduit and reach the outer environment, where there is a risk that they will be inhaled by the operator.

DE 3820204 discloses a device for filtering and transferring a fluid, in particular for medical use, into or from a container. The device comprises a support plate, formed through the juxtaposition of two portions, between which a first filter for liquid substances and a second filter for gaseous substances are placed. The two portions are made in such a way as to delimit two filter chambers, which do not communicate with each other, one for the first filter, the other for the second filter. One of the two opposite faces of the plate is provided with a perforating tip that is arranged axially, in the thickness of which a first conduit runs that communicates with the chamber provided with the first filter and a second conduit runs communicating with the chamber accommodating the second filter. On the face of the plate opposite the face accommodating the perforating tip a fitting conduit is inserted to receive an aspirating instrument, for example a syringe, and a vent conduit is inserted for the passage of gas, both conduits being eccentrically arranged in relation to a longitudinal axis of the device that passes through the tip. The fitting conduit communicates with the filtering chamber of the liquids, the vent conduit communicates with the filtering chamber of the gases. To facilitate the transit of the fluids into the respective filtering chambers, the latter are provided with channels radially arranged. In the portion of the plate comprising the perforating tip the radially arranged channels converge towards the internal discharge orifices of the first or of the second conduit. In the opposite portion of the plate, the radially arranged channels converge towards the internal discharge orifices of the fitting conduit or of the vent conduit .

When the device disclosed in DE 3820204 is used to deliver liquids into a container, for example to deliver a diluting liquid into a bottle containing a lyophilised pharmaceutical that is to be reconstituted, any toxic gaseous substances rising from the reconstituted pharmaceutical pass into the channel for the gases of the tip and then into the gas- filtering chamber. In this way, the harmful components of the gases are retained by the filter. After the pharmaceutical has been reconstituted, the latter is aspirated by the bottle, always by means of a syringe, and passing through the filtering-liquid chamber it is deprived of any residual solid particles. During this phase, the vent conduit enables the atmospheric air to enter the bottle, thereby enabling the latter to be emptied.

One disadvantage of the device disclosed in DE 3820204 is that it provides a substantially voluminous vent conduit that is therefore cumbersome during handling of the device by the operator.

Another disadvantage of the above-mentioned device is that the fitting conduit is positioned in a position that is shifted in relation to a longitudinal axis of the tip, which is located in a central position. This causes precarious balance when in use, for example when a syringe is connected to the device after the tip of the latter has been inserted into a stopper of the container, or during aspiration and/or delivery of the liquid by the syringe. This precarious equilibrium may cause accidental overturning of the device and consequent spreading of harmful substances in the environment .

An aim of this invention is to improve apparatuses for diluting and transferring pharmaceuticals. Another aim of the invention is to obtain an apparatus, provided with filtering means arranged to filter a preparation obtained by diluting a pharmaceutical in a diluting liquid and filtering means arranged to filter any harmful gaseous substances produced during said dilution, which can be conveniently used and without risk of accidents. A further aim of the invention is to obtain an apparatus for diluting and transferring pharmaceuticals that is provided with a substantially compact structure, i.e. without protruding elements that are positioned in such a way as to be cumbersome for the user.

Another further aim is to obtain an apparatus for diluting and transferring pharmaceuticals that enables the productive process to be simplified and material to be spared. A yet further object is to make an apparatus for diluting, filtering and transferring pharmaceuticals wherein filtering is extremely efficient.

According to a first aspect of the invention an apparatus is provided for diluting and transferring a liquid means, comprising a transit means for said liquid means for delivering said liquid means to a container or drawing said liquid means from said container, a passage means arranged to enable the passage of gas between said container and an outside environment, a casing means containing a gas-filtering means arranged to filter said gas and provided with an opening means for said gas, characterised in that said opening means is made in such a way as not to protrude from said casing means . Thanks to this aspect of the invention, gaseous substances can be made to enter and/or leave the device, thereby avoiding the use of conduit structures that are substantially cumbersome because they project externally from the casing means. This furthermore enables the quantity of raw material required to make said device to be reduced. According to a second aspect of the invention an apparatus is provided for diluting and transferring a liquid means, comprising a casing means provided with a fitting means arranged to receive a means for delivering and/or drawing said liquid means and an insertion means arranged to penetrate inside a container of said liquid means, said insertion means being substantially aligned on a longitudinal axis of said apparatus; characterised in that said fitting means is also substantially aligned on said longitudinal axis. Thanks to this aspect of the invention, the force exerted by an operator on the fitting means runs in a direction that is noticeably near a longitudinal axis of the apparatus. This significantly increases the stability of the apparatus during use. According to a third aspect of the invention, an apparatus for diluting and transferring a liquid means is provided, comprising a transit means of said liquid means for delivering said liquid means to or drawing said liquid means from a container, passage means arranged to enable the passage of gas between said container and an outside environment, a casing means containing a filtering means arranged to filter said liquid means and a gas-filtering means arranged to filter said gas; characterised in that in said casing means a cooperating means is provided that is arranged to promote the transit of said liquid means through said filtering means and/or of said gas through said gas-filtering means.

The above-mentioned cooperating means acts by distancing the filtering means and/or gas-filtering means from internal walls of the casing means and thus guaranteeing maximum available surface for filtering. In this way, accidental shifts of filtering means or gas-filtering means are furthermore avoided that obstruct the transit means through the thrust of the liquid or of the gas subjected to filtering. In addition, the cooperating means cooperate in forming channels that direct the liquids towards the transit means.

Thanks to this aspect of the invention, the apparatus has significant filtering efficiency, both in terms of available filtering surface and in terms of continuity of the filtering process .

In order that the invention may be clearly and completely disclosed, reference will now be made, by way of examples that do not limit the scope of the invention, to the accompanying drawings, wherein:

Fig. 1 is an exploded diagrammatic front view of the apparatus according to the invention;

Fig. 2 is a view from below of the top of the apparatus in

Fig. 1; Fig. 3 is a section III-III of Fig. 2;

Fig. 4 is a section IV-IV of Fig. 2;

Fig. 5 is a plan view of the bottom part of the apparatus in

Fig. 1;

Fig. 6 is a section VI-VI of Fig. 5; Fig. 7 is a section VII-VII of Fig. 5;

Fig. 8 is an enlarged and interrupted detail of an end zone of

Fig. 4;

Fig. 9 is an enlarged and interrupted detail of a central zone of Fig. 4; Fig. 10 is an enlarged and interrupted detail of an end zone of Fig. 7;

Fig. 11 is an enlarged and interrupted detail of a central zone of Fig. 7;

Fig. 12 is a longitudinal section of a further version of the apparatus disclosed in the invention;

Fig. 13 and Fig. 14 are enlarged and interrupted details of

Fig. 12.

Fig. 1 shows an apparatus 1 for diluting pharmaceuticals comprising a first portion 2 provided with a fitting 5, such as a LUER-LOCK, arranged for being coupled with a syringe (not shown) and a further portion 3 provided with a tip 4 suitable for being inserted inside a container (not shown) wherein a pharmaceutical that is to be diluted is contained. The apparatus 1 furthermore comprises an intermediate body 8, with a circular section, inside which a filtering means 6 is housed that is arranged to filter the preparation obtained by dilution of the pharmaceutical before this is transferred, by means of said syringe, to inside a collection container that is not shown.

The apparatus 1 furthermore comprises a gas-filtering means 7, which is also suitable for being positioned inside the intermediate body 8, arranged to filter any gases generated inside the container by chemical reactions that occur during dilution of the pharmaceutical before said gases are delivered into the surrounding environment.

The first portion 2 and the further portion 3 may be made out of plastic that resists diluting solutions and is also compatible with pharmaceuticals, particularly with pharmaceuticals containing lipids.

In one advantageous embodiment, said plastic is a transparent plastic.

During use of the apparatus this enables the filtering means 6 and the gas-filtering means 7 placed between the first portion 2 and the further portion 3 to be inspected.

It is therefore possible to check correct draining of the preparation containing the pharmaceutical through the filtering means 6 and simultaneously ascertain the presence of any particles with a large diameter or fragments of bottle stopper, which are retained by the filtering means 6. Said plastic is preferably polycarbonate.

Through a procedure of injection moulding this enables first portions and further portions of the apparatus to be obtained that have good mechanical resistance. Using polycarbonate to produce the first portion 2 and the further portion 3 enables the latter to be mutually connected permanently by means of ultrasonic sealing.

The gas-filtering means 7 can be made from a membrane in polyethersulphone.

In such cases the gas-filtering means 7 is suitable for being subjected to sterilisation treatment using ethylene oxide. The polyethersulphone membrane is not damaged by ultrasonic sealing by means of which the first part 2 is fixed to the further part 3.

The gas-filtering means comprising a polyethersulphone membrane is furthermore compatible with USP class VI. Figs. 2 to 11 show the first portion 2 and the further portion 3 of the apparatus 1, wherein a casing means 9 are identified that is suitable for receiving the filtering means 6 and the gas-filtering means 7.

In particular, the casing means 9 comprises a transit means 10 that is arranged to contain the filtering means 6 that is adjacent to the passage means 11, arranged to contain the gas- filtering means 7.

The casing means 9 are delimited by first casing means 9a made out in the first portion 2 and by second casing means 9b made out in the further portion 3. The first casing means 9a comprises first transit means 10a arranged for being coupled with second transit means 10b, obtained in the second casing means 9b, to delimit the transit means 10.

The first casing means 9a furthermore comprises a first passage means 11a arranged for being coupled with the second passage means lib, obtained in the second casing means 9b, to delimit the passage means 11.

The first casing means 9a comprises a first wall means 12 protruding from a first surface 13 of the first portion 2 that is suitable for being associated with a respective further surface 14 of the further portion 3, during a subsequent ultrasonic sealing phase whereby the first portion 2 and the further portion 3 are connected to define the intermediate body 8 of the apparatus 1. The first wall means 12 is closed in a ring and is configured in such a way as to define a peripheral edge of the first casing means 9a.

The first casing means 9a furthermore comprises a second wall means 15 and a third wall means 16, which also protrude from the first surface 13, arranged so as to peripherally delimit the first transit means 10a and the first passage means 11a, respectively.

The first wall means 12 defines, in combination with the second wall means 15 and the third wall means 16, a first groove 17 extending along the entire peripheral edge of the first casing means 9a.

Furthermore, between the second wall means 15 and the third wall means 16 a second groove is defined 18 that is arranged to separate the first transit means 10a from the first passage means 11a.

The further portion 3 comprises a first jutting element 19, that protrudes from the further surface 14, which element is closed in a ring and configured in such a manner as to delimit the second casing means 9b. Parallel to the first jutting element 19 and outside the second casing means 9b an annular groove 21 is made out that is arranged to receive the first wall means 12 when the first portion 2 is associated with the second portion 3, as will be described below. The further portion 3 furthermore comprises a second jutting element 20, which also protrudes from the surface 14, extending internally to the zone delimited by the first jutting element 19 to define the second transit means 10b and the second passage means lib in the second casing means 9b. During the assembly of the apparatus 1, the filtering means 6 and the gas-filtering means 7 are located inside the second casing means 9b, respectively in the second transit means 10b and in the second passage means lib. Subsequently, the first portion 2 is associated with the further portion 3 in such a way that the first surface 13 and the further surface 14 face one another.

In this way, the first casing means 9a interacts with the second casing means 9b to close the filtering means 6 inside the transit means 10 and the gas-filtering means 7 inside the passage means 11.

During the above-mentioned assembly, the first wall means 12 is received inside the annular groove 21 and the first jutting element 19 engages the first groove 17 in such a way that, following the junction of the first casing means 9a and of the second casing means 9b, the casing means 9 are defined. Simultaneously, the second jutting element 20 is received in the second groove 18 in such a way as to identify in the casing means 9 the transit means 10 and the passage means 11. As Figs. 7 and 10 show particularly clearly, the second casing means 9b is provided with a support means 22 arranged to support the filtering means 6 and the gas-filtering means 7, so as to maintain them at a set distance from a face that delimits the second casing means 9b at the bottom. During operation this prevents the filtering means 6 and/or the gas- filtering means 7 from resting on the above-mentioned face, thereby noticeably limiting the efficiency of the apparatus 1, or even making it unusable. The support means 22 comprises a step 23 extending along the first jutting element 19 and arranged to receive end zones of the filtering means 6 and of the gas-filtering means 7, which rest on said first jutting element 19.

As shown in Fig. 7, in the tip 4, which is associated with the further portion 3, third transit means 24 are made out that are provided with a first orifice 25 arranged to put into a container a liquid arranged to dilute a pharmaceutical, or to draw the diluted pharmaceutical from the above-mentioned container. The first orifice 25 is configured in such a way as to longitudinally occupy a set extension of the cone-shaped end 4a of the tip 4. In this way, in one work configuration wherein the tip 4 is arranged vertically in such a way that the cone-shaped end 4a is positioned higher than the body 8, it is possible to substantially draw the entire contents of the container associated with it thereby minimising in this way consumption of the pharmaceutical.

The third transit means 24 furthermore comprises a second orifice 26 opening inside the transit means 10. In the tip means 4 a third passage means 27 is furthermore made out that is provided with a further first orifice 28, arranged at the cone-shaped end 4a, and a further second orifice 29 opening inside the passage means 11. As Figs. 5 and 6 show, the second transit means 10a is provided with a rib means 30 that collaborates with the step 23 to support the gas-filtering means 6.

The rib means 30 furthermore defines the channels 31 that direct the liquid towards the second orifice 26. As Figs, from 2 to 4 show, the first portion 2 is crossed by a hole 32 arranged to make the fitting 5 communicate with the transit means 10.

In this way, by means of a syringe associated with the fitting 5, a diluting liquid can be placed inside a container containing a pharmaceutical in powder form, or a diluted pharmaceutical can be drawn from the container, said diluting liquid and diluted pharmaceuticals being made to pass through the filtering means 6.

The first seat means 10a is provided with a projection means 33 arranged to prevent the filtering means 6 from resting on the first transit means 10a, thereby obstructing the hole 32 and preventing the liquid from draining off.

The projection means 33 collaborates with the rib means 30 to keep the filtering means 6 advantageously separated from both the first transit means 10a and the second transit means 10b, in such a way as to maximise the active surface of the filtering means 6.

The first passage means 11a is provided with a plurality of opening means 34, made in the form of orifices and arranged to allow any gases containing toxic substances, produced after the dilution of the pharmaceutical, to be released into the outside environment after passing through the gas-filtering means 7. Advantageously, the opening means 34 furthermore enables appropriately filtered atmospheric air to penetrate the container containing the diluted pharmaceutical when the latter is drawn by a syringe, thereby enabling the container to be emptied.

Yet more advantageously, the opening means 34 is made in the entire extension of the first passage means 11a, to exploit the entire active surface of the gas-filtering means 7.

Figs. 12 and 13 show a possible embodiment of the invention wherein the tip 4 is replaced by a support body 40 made into a roughly trunk-conical shape that is elongated and hollow inside. The support body 40 is fixed to the further portion 3 near a central region of the latter, and is arranged to accommodate a perforating cannula 41, for example made of steel, provided internally with a conduit 57 and kept in their seat by gluing with a suitable adhesive means. The perforating cannula 41, accommodated for about two thirds of its own length inside the support body 40, comprises in its external third a terminal orifice 42. Advantageously, the terminal orifice 42 is arranged in a noticeably oblique manner in relation to a longitudinal axis X of the cannula 41. It is thus possible to efficiently draw from a container even small residual quantities of pharmaceutical. Alternatively, the cannula 41 may be of the so-called teaspoon' type, i.e. it may be curved near the terminal orifice 42. During use of the device this significantly reduces phenomena of 'coring', i.e. removal of fragments of stopper when said stopper is bored to access a container, which is not shown.

The end of the perforating cannula 41 opposite the end bearing the terminal orifice 42 comprises a joint portion 44. Near the first portion 2, the support body 40 accommodates a jacket 45 internally, having an open end to receive the perforating cannula 41 and the opposite end closed by a second jutting element 46 arranged to engage in the second channel 18 of the first portion 2. The jacket 45 is provided internally with an abutting edge 47, arranged as a ring at a certain distance from the second jutting element 46, and such as to accommodate the joint portion 44. Between the joint portion 44 and the further jutting element 46 there is thus comprised a bottom portion 49 of the jacket 45. The part of the bottom portion 49 pointing towards the transit means 10 defines a transit orifice 48, communicating by means of a transit conduit 52 having an arched longitudinal section, with the transit means 10. In this way, the conduit 57, the bottom portion 49 and the transit conduit 52 constitute a structure that is functionally analogous with the third transit means 24.

The support body 40, for a tract that is the same as about half its length, accommodates four ribs 50, roughly shaped in the form of a rectangular trapezium and arranged in such a way that any two are at right angles to each other. One of the ribs 50, i.e. the one nearest to the passage means 11, is hollow and delimits a passage chamber 54, provided with two lateral walls that are not shown, fixed to an intermediate wall 58. The jacket 45 partially separates the passage chamber 54 from the adjacent conduit 57, inasmuch as it is interrupted before reaching the zone near which the intermediate wall 58 fits onto the support body 40. The result is a first passage orifice 60, that makes the passage chamber 54 communicate with a hollow cylindrical cavity 56 running between the support body 40 and the perforating cannula 41 after the latter is housed in the support body 40. The passage chamber 54 opens at the bottom in the passage means 11 by means of a third passage orifice 61.

In this way, the passage chamber 54 and the hollow cylindrical cavity 56 form a structure that is functionally analogous to the third passage means 27.

Claims

1. Apparatus for diluting and transferring a liquid means, comprising a transit means (10, 24, 49, 52, 57) of said liquid means for delivering to and/or drawing from a container said liquid means, a passage means (11, 27, 54, 56) arranged to enable the passage of gas between said container and an external environment, casing means (2, 3, 8, 9) containing a gas-filtering means (7) arranged to filter said gas and provided with and opening means (34) for said gas, characterised in that said opening means (34) is made in such a way as not to protrude from said casing means (2, 3, 8, 9).

2. Apparatus according to claim 1, wherein said casing means

(2, 3, 8, 9) furthermore comprise an insertion means (4, 40, 41) arranged to penetrate said container of said liquid means and aligned on a longitudinal axis of said contrivance.

3. Apparatus according to claim 1, or 2, wherein said casing means (2, 3, 8, 9) furthermore comprise a fitting means (5) arranged to receive a means for delivering and/or drawing said liquid means.

4. Apparatus according to claim 3, when dependent on claim 2, wherein said fitting means (5) is substantially aligned on said longitudinal axis.

5. Apparatus for diluting and transferring a liquid means, comprising a casing means (2, 3, 8, 9) provided with a fitting means (5) arranged to receive a means for delivering and/or drawing said liquid means and with an insertion means (4, 40, 41) arranged to penetrate inside a container of said liquid means, said insertion means (4, 40, 41) being substantially aligned on a longitudinal axis of said apparatus; characterised in that said fitting means (5) is also substantially aligned on said longitudinal axis.

6. Apparatus according to claim 5, furthermore comprising transit means (10, 24, 49, 52, 57) of said liquid means for delivering to and/or drawing from said container said liquid means.

7. Apparatus according to claim 6, furthermore comprising a passage means (11, 27, 54, 56) arranged to enable the passage of gas between said container and an outside environment.

8. Apparatus according to claim 7, furthermore comprising casing means (2, 3, 8, 9) containing a gas-filtering means (7) arranged to filter said gas and provided with an opening means (34) .

9. Apparatus according to claim 8, wherein said opening means (34) is made in such a way as not to protrude from said casing means (2, 3, 8, 9) .

10. Apparatus for diluting and transferring a liquid means, comprising a transit means (10, 24, 49, 52, 57) of said liquid means for delivering said liquid means to or drawing said liquid means from a container, a passage means (11, 27, 54, 56) arranged to enable the passage of gas between said container and an external environment, casing means (2, 3, 8, 9) containing a filtering means (6) arranged to filter said liquid means and a gas- filtering means (7) arranged to filter said gas; characterised in that in said casing means (2, 3, 8, 9) a cooperating means is provided (23, 30, 33) that is arranged to assist the transit of said liquid means through said filtering means (6) .

11. Apparatus according to claim 10, wherein said casing means (2, 3, 8, 9) comprise an opening means (34) for said gas.

12. Apparatus according to claim 11, wherein said opening means (34) is made in such a way as not to protrude from said casing means (2, 3, 8, 9) .

13. Apparatus according to claim 10, or according to claim 12, furthermore comprising a fitting means (5) arranged to receive a means for delivering and/or drawing said liquid means.

14. Apparatus according to claim 13, wherein said casing means (2, 3, 8, 9) comprise an insertion means (4, 40, 41) arranged to penetrate inside a container of said liquid means .

15. Apparatus according to claim 14, wherein said insertion means (4, 40, 41) is substantially aligned on a longitudinal axis of said contrivance.

16. Apparatus according to claim 15, wherein said fitting means (5) is substantially aligned on said longitudinal axis.

17. Apparatus according to one of the preceding claims, wherein said casing means comprise a first portion (2) and a further portion (3) that are opposite one another.

18. Apparatus according to claim 17, wherein said casing means furthermore comprise an intermediate body (8), formed by the juxtaposition of said first portion (2) and said further portion (3) in relation to each other.

19. Apparatus according to claim 18, wherein said intermediate body (8) is disk-shaped.

20. Apparatus according to claim 19, or 18, wherein said casing means comprise a first casing means (9a) made out in the first portion (2) and a second casing means (9b) made out in the further portion (3) .

21. Apparatus according to claim 20, wherein said first casing means (9a) comprises first transit means (10a) arranged for being coupled with second transit means (10b) obtained in said second casing means (9b) .

22. Apparatus according to claim 21, wherein a filtering means (6) is placed between said first transit means (10a) and said second transit means^' (10b) that are coupled together.

23. Apparatus according to anyone of claims 10 to 22, wherein said cooperating means comprises a rib means (30) made in said second transit means (10b) such as to identify preferential routes (31) .

24. Apparatus according to anyone of claims 10 to 22, or according to claim 23, wherein said cooperating means comprises a projection means (33) made in said first transit means (10a) .

25. Apparatus according to claim 24, wherein said projection means comprises a plurality of raised edges that are parallel to one another.

26. Apparatus according to anyone of claims 10 to 25, wherein said cooperating means comprises a step means

(23) made in said second transit means (10b) and arranged to support said filtering means (6) by interacting with the end zones of the latter.

27. Apparatus according to anyone of claims 20 to 26, wherein said first casing means (9a) comprises a first passage means (11a) arranged for being coupled with the second passage means (lib) obtained in said second casing means (9b) .

28. Apparatus according to claim 27, wherein said gas- filtering means (7) is placed between said first passage means (11a) and said second passage means (lib) that are coupled together.

29. Apparatus according to claim 28, wherein said first passage means (11a) comprises said opening means (34) .

30. Apparatus according to anyone of claims 5 to 29, wherein said insertion means comprises a tip means (4) fixed to said further portion (3) .

31. Apparatus according to claim 30, wherein third transit means (24) is made inside said tip means (4).

32. Apparatus according to claim 31, wherein said third transit means (24) comprises a first orifice (25) and a second orifice (26) .

33. Apparatus according to claim 32, wherein said second orifice (26) opens in said second transit means (10b).

34. Apparatus according to claim 32, or 33, wherein said first orifice (25) is configured in such a way as to longitudinally occupy a preset extension of a cone-shaped end (4a) of said tip means (4).

35. Apparatus according to claim 30, or according to anyone of claims 31 to 34, wherein a third passage means (27) is made inside said tip means (4).

36. Apparatus according to claim 35, wherein said third passage means (27) comprises a further first orifice (28) and a further second orifice (29) .

37. Apparatus according to claim 36, wherein said further second orifice (29) opens in said second passage means (lib) .

38. Apparatus according to anyone of claims 5 to 29, wherein said insertion means comprises a perforating- cannula means (41) housed in a support-body means (40) .

39. Apparatus according to claim 38, wherein transit means are provided that comprises a conduit means (57) contained in said perforating-cannula means (41).

40. Apparatus according to claim 39, wherein said conduit means (57) opens in a terminal orifice (42).

41. Apparatus according to claim 40, wherein said perforating-cannula means (41) has a curved portion near said terminal orifice (42) .

42. Apparatus according to anyone of claims 38 to 40, or

38 to 41, wherein said support-body means (40) internally comprises a jacket means (45) , provided with a jutting means (46) arranged to engage with said first portion

(2) .

43. Apparatus according to claim 42, wherein said jacket means (45) comprises an abutting edge means (47), positioned at a certain distance from said jutting means

(46) and arranged to receive a support portion (44) of said perforating-cannula means (41) .

44. Apparatus according to claim 43, wherein a transit means is provided that comprises a bottom portion (49) of said jacket means (45), placed between said jutting means (46) and said support portion (44).

45. Apparatus according to claim 44, wherein a transit means is provided that comprises a recess means (52) placed between said bottom portion means (49) and said second transit means (10b) .

46. Apparatus according to claim 38, or according to anyone of claims 39 to 46, wherein said support-body means (40) is provided with a plurality of ribs (50) arranged near said further portion (3) .

47. Apparatus according to claim 46, wherein a passage means is provided that comprises a passage-chamber means (54) made in said ribs (50).

48. Apparatus according to claim 47, wherein a passage means is provided that comprises a hollow cylindrical cavity means (56) placed between said perforating-cannula means (41) and said support-body means (40) , and arranged to communicate with said passage-chamber means (54).

49. Apparatus according to claim 48, wherein said passage-chamber means (54) opens in said second passage means (lib) .