PT2879644T - Device for the filling of containers for medical use having a closing membrane which can be perforated - Google Patents

Description

DESCRIPTION

DEVICE FOR FILLING CONTAINERS FOR USE

CLINIC HAVING A CLOSING MEMBRANE TO WHICH CAN BE PUNCHED "

Technical Field The present invention relates to a device for filling containers for clinical use having a closure membrane which can be perforated, in particular, of the type suitable for containing a radioactive pharmaceutical. Background Art It is known that pharmaceuticals of the radioactive type or the like are characterized by a very rapid deterioration time, i. i.e., lose their therapeutic properties over a period of time of a few hours.

For this reason, it is absolutely indispensable that they be "consumed" some time after their preparation.

It is thus apparent that their preparation plays a crucial role because it has to occur within a very short time and under conditions in order to prevent any contamination of the pharmaceutical product.

For this reason, to date, there are two known methods for the preparation of such pharmaceutical products, i.e., for the preparation of the respective single-dose containers. The first type envisages establishing a sterile environment using appropriate equipment which, on the other hand, is very costly and thus requires high investment costs. The second type, which is the subject of the present invention, relates, on the contrary, to the use of consumable devices which are suitable for defining a closed circuit within which the pharmaceutical product is introduced.

More particularly, such known devices are applicable to a glass container (also known by the name of vial) closed at the top by a perforable membrane and comprise a pharmaceutical feed element, which is adapted in the container and which in turn is connected to a series of tubes suitable for transporting the pharmaceutical product, introduced thereinto by means of a syringe, towards the glass container. The forefeeding member comprises two needles, suitable for piercing the membrane, for introducing the pharmaceutical into the container and for allowing air to exit therefrom.

To drill the membrane, an operator applies a pressure to the bottom of the vessel so as to effect relative movement of the membrane itself relative to the needles.

However, such known devices also have disadvantages.

In practice, such devices are in no way practical to use, because it is difficult for the operator to apply the force required to drill the membrane, because of the only available pressure surface, to be the lower part of the container, being the top occupied by the needles. This problem is even more serious if one considers that the perforation of the membrane is generally activated by holding the device itself inside a flexible package in order to protect its sterilization.

A further disadvantage is that they do not allow a correct perforation of the membrane, with the consequent risk of accidental leakages of the pharmaceutical product from the container.

This is due to the fact that the needles are arranged inclined relative to one another to allow the positioning of a Luer-lock type connection for connection of the aforementioned tubes and an air filter, which have considerably larger overall transverse dimensions than those of the needles themselves. This implies that the direction of approach of the needles to the membrane does not correspond to their longitudinal extent, and the orifices thus obtained thus have an oval shape and thus do not guarantee a correct seal. Yet another disadvantage of such devices of known type is the risk of needle links to the pharmaceutical carrier tubes being accidentally detached, thereby resulting in undesirable loss of the pharmaceutical product itself, as well as possible contamination of medical personnel.

Other devices of known type for filling containers for clinical use are known from DE202009011019, EP1323403 and W02004041148.

The main object of the present invention is to provide a device for filling containers for clinical use having a closure membrane which is much easier to use compared to devices of known type and which, at the same time, are easy and practical to remove from their container.

In particular, the present invention proposes to provide a device that can be operated by an operator in a simple manner without any particular effort, including inside the flexible package used for maintenance of its sterilization.

A further object of the present invention is to pierce the membrane of the respective container in order to prevent undesired leakage of the pharmaceutical product contained therein.

Yet another object of the present invention is to considerably reduce the risk that the connections of the tubes suitable for transporting the pharmaceutical into the device will be accidentally removed.

A further object of the present invention is to provide a device for filling containers for clinical use having a pierceable closure membrane which allows overcoming the mentioned disadvantages of the prior art within the scope of a simple and effective solution to be used, as well as low cost. The objects set forth above are obtained by the present device for filling containers for clinical use having a closure membrane which can be perforated, in particular the type suitable for containment of radioactive pharmaceutical products, according to claim 1.

Brief Description of Drawings

Other features and advantages of the present invention will become more apparent from the description of a preferred but not unique embodiment of a device for filling containers for clinical use having a closure membrane which can be perforated , shown merely as an example, but not limited to the accompanying drawings, in which: Figure 1 is an exploded view of a device according to the invention in a first embodiment; Figure 2 is a front axonometric view of the device of Figure 1 with the second portion of the element for feeding the pharmaceutical into a rest position; Figure 3 is a rear axonometric view of the device of Figure 2; Figure 4 is a longitudinal cross-sectional view of the device of Figure 2; Figure 5 is a front axonometric view of the device of Figure 1 with the second portion of the element for feeding the pharmaceutical into a working position; Figure 6 is a rear axonometric view of the device of Figure 5; Figure 7 is a longitudinal cross-sectional view of the device of Figure 5; Figure 8 is a top plan view of an assembly according to the invention.

Embodiments of the Invention

With particular reference to such figures, generally indicated by the reference numeral 1, a device for filling containers C for clinical use having a closing membrane M which can be perforated, in particular, the type suitable for containment of products radioactive pharmaceuticals. The device 1 and the container C, together, define an apparatus 30 for preparing radioactive pharmaceutical products, or the like. The device 1 comprises a pharmaceutical feed element 2 which can be adapted in a container C and having at least one pair of needles 3, 4 suitable for piercing the membrane M of the container itself.

More in detail, the feed member 2 comprises a first needle 3 suitable for transporting the pharmaceutical into the container C and a second needle 4 suitable for allowing the air to exit the container itself. The word "needle" used herein means any member suitable for piercing the membrane M. The feeder element 2 comprises a first portion 5 associable with the container C and at least a second portion 6, which supports the associated movable needles 3, 4 with the first part 5.

Suitably, the first part 5 is hollow in the interior and has a support wall 5a intended to remain against the upper edge of the container C and a side wall 5b which extends substantially perpendicularly from the support wall 5a.

In more detail, in the embodiment shown in the drawings, the support wall 5a has a plurality of projections contacting directly with the upper edge of the container C. The support wall 5a is crossed by a hole 15 suitable to enable the needles 3 and 4 pass therethrough. The second part 6 is movable between a rest position, in which it is raised relative to the first part 5 and the needles 3, 4 are spaced apart from the membrane M, and a working position, wherein the second part 6 is close to the first part 5 relative to the resting position and where the needles 3 and 4 pierce the membrane M.

Preferably, the second portion 6 is movably associated in translation with respect to the first portion 5 along a direction of sliding indicated in the illustrations by the arrow 7.

In more detail, the first and second portions 5 and 6 have a respective reference axis and the sliding direction 7 substantially coincides with such an axis.

In the embodiment shown in the illustrations, the first and second portions 5 and 6 have a substantially circular cross-section, ie, have respective sidewalls, identified in the illustrations by reference numerals 5b and 6a, the cross-sections of which have, at least , an extension extending along a circumference. In other words, the side walls 5b and 6a have at least one cylindrical portion.

In the embodiment shown in the illustrations, the second part 6 is slidably fitted onto the first part 5. More in particular, the second part 6 comprises a housing support 22 inside which at least a portion of the part side wall 5b of the first part 5. Such a housing support 22 is of the passage type, has a curvilinear profile and is turned, as can be seen in the illustrations 2 and 3, to the upper face of the second part 6. The wall 5b side portion of the first portion 5 has an aperture 23 delimiting two areas having heights different from each other, where only the larger area is inserted into the housing support 22. Suitably, the first part 5 comprises a swelling 5c disposed at the base of the side wall 5b and suitable to be fitted onto the container C.

It will be apparent to one skilled in the art that the conformations described herein of the first and second parts 5 and 6 and the respective coupling procedures are given by way of example, and that these may be modified without affecting the entire operation of the device 1, without impairing the fact that the second part 6 must be movably coupled with respect to the first part 5. The second part 6 defines a pressure surface 8 accessible from the outside, which is substantially opposite and parallel to the lower part of the container C and which is intended to be pressed by an operator so as to move the second part itself from the rest position to the working position. More in detail, the pressure surface 8 is defined in the wall delimiting the top of the second portion 6 and is substantially arranged orthogonally to the sliding direction.

Advantageously, the needles 3 and 4 associated with the second portion 6 are disposed substantially parallel (with the exception of the manufacturing tolerances), relative to one another. More particularly, needles 3 and 4 are arranged substantially parallel to the sliding direction 7 of the second portion 6 so that the perforation direction of the membrane M corresponds to the direction of the longitudinal extension of the needles 3 and 4, holes defined therein are substantially circular.

In the illustrated embodiment, the needles 3 and 4 have respective outlet openings inclined relative to their longitudinal extent and diverge from each other, proceeding from the feed element 2 towards the container C. In order to prevent following perforation of membrane M, needles 3 and 4 reciprocally move closer to one another.

In an alternate embodiment, the outlet apertures of the needles 3 and 4 are substantially inclined in the same direction. The second part 6 thus comprises first and second housing support 9 and 10 of the first and second needles 3 and 4, respectively, which are arranged parallel to each other and communicating with a first conduit 11 for the flow of the pharmaceutical product, and with a second conduit 12, suitable for transporting the air towards the outside, respectively. The first conduit 11 is thus associated with a tubular member 13 suitable for transporting the pharmaceutical into the first needle 3 and the second conduit 12 is associated with a filtering element 14 suitable for preventing the impurities from entering from the outside.

In particular, in the embodiment shown in the drawings, the tubular element 13 is adapted to be fitted onto the protrusion 24 defined on the upper part of the second part 6 traversed by the first conduit 11. However, it can not be excluded that in one embodiment Alternatively, the tubular member 13 is inserted into the first conduit 11, the latter defining a respective housing support for the tubular member itself. The second conduit 12 in turn defines a housing support for the filter element 14, which is thus at least partially contained within the second part 6. Suitably the tubular element 13 and the element 14 are integrally associated with the first and second conduits 11 and 12, respectively, e.g. by the interposition of adhesive means, such as adhesives or the like.

Preferably, the first and second conduits 11 and 12 are adapted to diverge from one another toward the outside, meaning that they move away from one another. More particularly, in the embodiment shown in the drawings, the first and second conduits 11 and 12 are adapted substantially orthogonal to one another and are facing the vicinity of the pressure surface 8 and on the side wall 6a of the second part 6, respectively.

Suitably, the aperture 23 defined in the side wall 5b is substantially aligned with the second conduit 12 so that the side wall itself does not obstruct it as the second portion 6 moves into the working position.

According to the invention, the device 1 comprises removable attachment means 17 of the first part 5 in the container C.

The securing means 17 comprises at least one locking type locking element 18 defined in the first part 5 and configured to cooperate with the container C to lock the position of the first part 5 relative thereto. The fastening element 18 is movable between a fastening arrangement, cooperating with the container C to lock the position of the first part 5, and a release configuration, in which it moves away from the container itself to release the first portion 5 The fastening element 18 thus comprises at least one inner bearing surface 25 suitable to cooperate with the edge of the container C to lock the position of the first part 5 relative to the container itself.

Preferably, the first portion 5 comprises a plurality of through cuts 27 delimiting a

plurality of elastic closure fastening elements 18. The first part 5 is thus clamped with the container C, automatically moving into the fastening configuration, and can be removed from the container itself by applying a force on the first part 5 towards the movement away from the container C. According to the invention, the device 1 also comprises identification means for identifying the position of the second part 6 relative to the first part and which are suitable for temporarily turning the first part 5 integral with the second part 6 in the rest position and job position.

More in detail, such identification means comprises a pair of apertures 20a, 20b of which a first aperture 20a and a second aperture 20b defined in the first portion 5 and disposed at a distance from one another along the sliding direction 7, at least one projection 21, defined in the second part 6. Suitably the wall bearing the projection 2 is elastic closure and the projection itself is clipped inside the first aperture 20a, when the second part 6 is in the and is stapled within the second aperture 20b when the second portion 6 is in the working portion. The introduction of the flange 21 into the first or the second apertures 20a, 20b thus enables identifying that the rest position and working position, respectively, of the second part 6 have been reached respectively. The introduction of the flange 21 into the first and the second apertures 20a and 20b, also makes it possible to make the first and second parts 5 and 6 integral with one another. It is easy for the person skilled in the art to understand that the apertures 20a and 20b and the protrusion 21 may be inverted, i.e. that the first part can be defined in the second part 6 and that the latter can be defined in the first part 5. According to the invention, the second part 6 also comprises a support element 26 suitable for being intercepted by the operator through holding means for applying a force on the first part 5 in a movement away from the container C, so as to separate the feed element 2 from the container C. The support element 26 defines a bearing support surface 26a facing a surface 28 defined by the first part 5, wherein the bearing surface 26a is spaced apart from the reference surface 28 with the second part 6 in the working position. The bearing surface 26a and the reference surface 28 thus define a housing area 29 positioned therebetween for introduction of the aforementioned gripping means.

More particularly, the bearing surface 26a extends transversely to the axis of the second portion 6.

In the illustrative embodiment, the bearing member 26 extends radially from the side wall 6a toward the outside. The bearing surface 26a and the reference surface 28 are both arranged transversely to the sliding direction.

In the embodiment shown in the illustrations, the support member 26 has a substantially annular shape and is defined in correspondence with the end of the second portion 6 facing the first portion 5. The present invention also relates to a set 50 for the preparation of medicinal products comprising at least one apparatus 30 according to what has been described previously, and thus consisting of a device 1 associated with a container C, at least one syringe 51 containing the pharmaceutical product to be introduced into the container itself, suitable valve means 52 for hydraulically connecting the syringe 51 to the device 1 and at least one support package 53. The valve means 52 also comprises the above-mentioned tubular element 13. The package 53 has at least one housing support 54 for the device 1 and at least one tray 55 for containing at least one syringe 51. In the embodiment shown in the illustrations, the package 53 comprises a plurality of bearings 54. The package 53 is configured so that the second portion 6 in its rest position protrudes from the respective bearing 54 and that the pressure surface 8 is spaced from the wall 55a which delimits the tray 55 and faces towards the bearing 54. The aim of this is to enable the operator to easily intervene on the pressure surface 8 and thus to move the second part 6 into the working position. Advantageously, the support 54 has at least one pair of stop surfaces 56 facing each other and suitable for cooperating with the respective counter-stop surfaces defined by the device 1 and, more particularly, by the first part 5.

Suitably, the assembly 50 also comprises at least one sealed flexible bag (not shown in the illustrations), preferably two, containing the package 53, the apparatus 30, the syringe 51 and the valve means 52 . The operation of the present invention is as follows.

As previously mentioned, the apparatus 30 consisting of the assembly consisting of the device 1 and the container C is initially associated with the package 53, which in turn is fitted into one or more flexible bags.

In this configuration, the first portion 5 is associated with the container C through the attachment means 17 and the second portion 6 is disposed in the rest position.

In order to be able to introduce the pharmaceutical into the container C, the membrane M must be perforated and consequently the second part 6 must be moved from the rest position to the working position.

In order to do this, the operator intervenes in the apparatus 30 by contacting the lower part of the container C and the pressure surface 8 and pressing one toward the other in a reciprocating approach direction. This causes sliding of the second part 6 relative to the first part 5 and, consequently, the perforation of the membrane M by the needles 3 and 4. The obtaining of the working position by the second part 6 is identified by the stapling of the flange 21 inside the second opening 20b defined in the first part 5.

With the second part 6 in the working position, the filling of the container C with its pharmaceutical product can thus be started.

More in detail, the pharmaceutical is injected by means of a syringe 51 and arrives at the first conduit 11 passing through the valve means 52. The thus injected pharmaceutical product thus enters into the container C passing through the first needle 3.

At the same time, during the filling of the container C with its pharmaceutical, the air initially contained therein exits towards the outside passing successively through the second needle 4, the second conduit 12 and the filter element 14.

As soon as the filling of the container C has been completed, the device must be removed therefrom to enable the use of the pharmaceutical product.

To remove the device 1, the fastening elements 18 should be released from the container C, moving them from the fastening configuration to the release configuration. The movement of the fastening elements 18 is, in the described embodiment, effected by the application of a traction force in correspondence with the bearing element 26 defined in the second part 6, so as to release the respective bearing surfaces 25 the trailing edge of the container C. Such traction force is applied by the introduction of gripping means into the housing area 29 positioned between the bearing surface 26a and the reference surface 28 and displacing it in a direction opposite to the sliding direction 7 , so as to contact the bearing surface 26a.

The securing elements 18 thereby disengage from the container C, thereby allowing removal of the device 1 therefrom.

In fact, the manner in which the disclosed invention achieves the proposed objects has been determined, and in particular it is emphasized that the device embodying the subject invention provides an easy to use and reliable operation. In particular, the device constituting the subject of the present invention is easy to operate by an operator through the effect of the reciprocal sliding of the first and second portions and at the same time is easy to remove due to the presence of the housing area which allows the introduction of gripping means.

Furthermore, the device according to the invention allows for the perfect positioning of the needles for piercing the membrane of the respective container and, thereby, considerably reduces the risk of subsequent leakage.

Finally, the device embodying the subject of the present invention allows avoiding the use of removable connections to connect the pharmaceutical delivery tubes, thereby reducing the risk of leakage occurring due to accidental detachment thereof.

Claims (15)

A device (1) for filling containers (C) for clinical use having a closure membrane (M) which can be perforated, in particular, of the type suitable for containment of radioactive pharmaceutical products, comprising: (2) for feeding a pharmaceutical product which can be adapted in a container (C) and having at least one pair of needles (3, 4) suitable for drilling the membrane (M) of the container itself, of which one first needle (3) suitable for transporting the pharmaceutical into the container (C) and a second needle (4) suitable for allowing air to exit said container (C), said feeding element comprises a first portion (5) connectable to said container (C) and at least a second portion (6), which supports said needles (3, 4) and associated movable with said first portion (5) between a resting position, in which this is high said first part (5) and said needles (3, 4) are spaced apart from said membrane (M), and a working position, said second portion (6) being close to said first portion (5) relative to the rest position and wherein said needles (3, 4) pierce said membrane (M); - removable attachment means (17) of said first portion (5) for said container (C); characterized in that it comprises identification means (20a, 20b, 21) for identifying the attainment of the rest position and the working position, respectively by said second part (6) relative to said first part (5), said (5) fixed relative to said second portion (6) in a removable manner and in that said second portion (6) has at least one support element (26) defining a surface ( 26a) facing a reference surface (28) defined by said first portion (5), said support surface (26a) being spaced apart from said reference surface (28) with said second portion (6) at (29) positioned therebetween for introducing suitable gripping means to remove said securing means (17) for separating said housing member (2) from the vessel (C). Device according to claim 1, characterized in that said second part (6) has a reference axis and in that said bearing surface (26a) extends transversely to said reference axis. Device according to claim 1 or 2, characterized in that said second part (6) has a side wall (6a) having a substantially cylindrical shape and in that said bearing element (26) protrudes radially from said wall (6a) towards the outside. Device according to one or more of the preceding claims, characterized in that said support element (26) has a substantially annular shape. Device according to one or more of the preceding claims, characterized in that said securing means (17) comprise at least one elastic closure fastening element (18), defined in said first part (5) and configured in order to cooperate with said container (C) to lock the position of the first part, relative to said container (C). Device according to one or more of the preceding claims, characterized in that said second part (6) is movably associated in translation with respect to said first part (5) along at least one direction (7) of Slipping. Device according to one or more of the preceding claims, characterized in that said second part (6) defines at least one pressure surface (8) accessible from the outside, which is arranged opposite the lower part of said container ( C) and transverse to said sliding direction (7), said pressure surface (8) being suitable for being pressed by an operator to move said second portion (6) from said rest position to said working position . Device according to one or more of the preceding claims, characterized in that said needles (3, 4) are arranged parallel to one another. Device according to one or more of the preceding claims, characterized in that said sliding direction (7) is substantially parallel to the longitudinal extent of said needles (3, 4). Device according to one or more of the preceding claims, characterized in that said needles (3, 4) have a respective outlet opening inclined with respect to their longitudinal extent, said outlet apertures diverging from one another, proceeding from the said feed element (2) towards said container (C). Device according to one or more of the claims from 1 to 9, characterized in that said needles (3, 4) have a respective exit aperture inclined with respect to their longitudinal extensions, said exit apertures being substantially inclined in the same direction . Device according to one or more of the preceding claims, characterized in that said second part (6) comprises first and second housing supports (9, 10) of said first and second needles (3, 4), respectively, which are arranged parallel to one another and which communicate with a first conduit and a second conduit (11, 12) respectively communicating with the outside. A device according to claim 12, characterized in that said first and second conduit (11, 12) are arranged diverging from one another towards the outside. Device according to one or more of the preceding claims, characterized in that it comprises at least one tubular element (13) integrally associated with said first conduit (11) and / or at least one filter element (14) integrally associated with said second conduit (12). An assembly (50) for the preparation of medicinal products, characterized in that it comprises at least one syringe (51) containing a pharmaceutical product for preparing at least one device (1) according to one or more of the preceding associated claims (C) for filling, valve means (52) suitable for connecting said syringe (51) to said device (1), at least one package (53) having at least one support ( 54) for housing said container (C) and at least one tray (55) for containing at least said syringe (51), said second portion protruding from said support (54) in its rest position, in which said pressure surface (8) is spaced from the wall (55a) which delimits said tray (55) and faces towards the support itself.