Apparatus for reconstitution, withdrawal and administration of drugs or nutrients obtained from active substances in powder, liquid or gel form contained in vials or other containers with hermetic closure

Abstract

An apparatus for reconstitution, withdrawal and administration of drugs or nutrients obtained from active substances in powder, liquid or gel form contained in vials or other containers with hermetic closure, comprises a sealed flexible bag (2) and a hooking and piercing device (19) which is hookable to the closure plug (23) of a vial (22) containing an active substance (52) in powder, liquid o gel form for simultaneous piercing of said plug (23). The bag (2) is divided into two bag portions (3, 5). A first bag portion (3) has a first internal space (4) fillable with a sterile liquid sterile (51) and a second bag portion (5) having a second internal space (6) communicating with said hooking and piercing device (19). The two bag portions (3, 5) are separated by a hermetic transversal welding (7) which prevents communication between the first internal and second internal spaces (4, 6) and is openable by lateral compression of said first bag portion (3). There is provided at least a divarication tube (16) which keeps spaced the walls of said second bag portion (5).

Description

[0001] “Apparatus for reconstitution, withdrawal and administration of drugs or nutrients obtained from active substances in powder, liquid or gel form contained in vials or other containers with hermetic closure”.

[0002] * * * *

[0003] DESCRIPTION

[0004] The present invention relates to an apparatus for reconstitution, withdrawal and administration of drugs or nutrients obtained from active substances in powder, liquid or gel form contained in vials or other containers with hermetic closure.

[0005] In hospitals the need exists to administer pharmaceutical or nutritional active substances in powder, liquid or gel form kept under vacuum inside sealed vials.

[0006] In order to make the active substances suitable for administration (infusion or other method) it is necessary to form a liquid mixture comprising, in addition to the active substance, a liquid solution suitably chosen.

[0007] A known apparatus usable for such an aim is described in the application PCT / IB2022 / 059123 and comprises a sealed flexible bag having an internal space filled or fillable with a sterile liquid. A hooking and piercing device for the closure plug of a vial containing an active substance is connected to said flexible bag through a flexible tube wherein a breakable hermetic closing element is housed that, after hooking the plug of the vial, is broken by the operator in order to open the communication between the internal space of the bag and that of the vial for the ensuing formation of a mixture of active substance and sterile liquid.

[0008] Such breakable closing element (normally a fracture cone) has drawbacks deriving from the cost of the component and of the relative labour and also due to the breaking particles produced by the component itself.

[0009] Aim of the present invention is providing an apparatus of the above-said type that can dispense with such breakable element.

[0010] According to the invention, such an object is achieved by an apparatus wherein the breakable closing element is replaced by an empty portion of bag confining with the portion of bag filled with the sterile liquid, but is hermetically spaced from it through a transversal welding that can be opened through a simple manual pressure from outside the bag, as better defined in claim 1.

[0011] In this way, any cost and drawback up to now connected to the presence of the breakable closing element are removed, and moreover a volume of sterile air is rendered available, that at the moment of hooking and piercing the closure plug of the vial enters into the vial in order to compensate for its vacuum state and to promote the complete mixing of the active substance with the sterile liquid of the bag.

[0012] The features of the present invention will be more apparent from the following detailed description of an embodiment thereof, shown by way of example in the accompanying drawings, in which: figure 1 shows an apparatus according to the present invention with a portion of bag filled with sterile liquid and before its hooking to a vial containing an active substance; figure 2 shows the same apparatus in a longitudinal section according to the line II-II of figure 1, before and after the opening of the transversal welding of the bag; figure 3 shows the detail of a possible kind of hooking of the apparatus of figures 1-2 to a vial containing an active substance.

[0013] The apparatus shown in the drawings, wherein it is overall indicated with the numeral 1, comprises a sealed flexible bag 2 that comprises a first bag portion 3, with an internal space 4 of bigger dimensions and a second bag portion 5 with an internal space 6 of smaller dimensions. The two spaces 4 and 6 of the bag 2 are spaced by a hermetic transversal welding 7 of the so- called “peelable” type, i.e. openable through pressure.

[0014] The internal space 4 can be accessed from outside through a tube 8 crossing an end of the bag 2 in correspondence of the bag portion 3, to which a connector 9 of the kind described in EP 2 667 839 Bl is applied, i.e. internally provided with a hermetic closure valve 10 openable by axial pressure exerted from outside and hermetically re-closable when said axial pressure ceases. The connector 9 ends with an externally threaded end 11 on which, after the removal of a cap 12, an internally threaded end of a filling or withdrawing device can be screwed, like a syringe with a luer end that can be inserted axially inside the valve 10 of the connector 9, as shown in EP 2 667 839 B1.

[0015] The same internal space 4 can be accessed from outside, too, through an administration tube 13 crossing the same end of the bag 2 and to which a connector 14 is applied, suitable for connecting an IV administration set and provided with a breakable and removable closure element 15. The connector 14 is for example of the type described in EP 4 000 679 Al.

[0016] The opposed end of the bag 2, corresponding to the bag portion 5, is in its turn crossed by a first rigid tube 16 provided with a closure plug 17, and by a second rigid tube 18 to which a device 19, suitable for hooking a closure plug of a vial (or similar) containing a pharmaceutical or nutritional active substance and for the simultaneous piercing of the same plug.

[0017] The rigid tube 16, with other analogue (not shown) tubes, has the function of keeping spaced the walls of the bag portion 5 so as to create an empty space containing sterile air.

[0018] The device 19 is for example of the type described in the application PCT / IB2022 / 059123 and comprises a hooking portion 20 intended for hooking the plug of the vial and a piercing portion 21 consisting in an axially bored stem that at the moment of hooking (having previously removed a closure cap 24) is forced to be inserted in the closure plug of the vial in order to pierce it and to consequently open the communication between the tube 18 and the inside of the vial, as shown in figure 3 wherein the vial is indicated with the numeral 22 and its axially perforable closure plug is indicated with the numeral 23. The mode of use of the apparatus of figures 1-3 for administering a drug or a nutrient will be described hereunder.

[0019] With the space 4 of the bag portion 3 previously filled with a sterile liquid 51, where appropriate with the addition of a liquid drug insertable through the connector 9, the hermetic transversal welding 7 holds the liquid 51 in said internal space 4 preventing it from reaching the internal space 6 of the bag portion 5, and therefore the hooking and piercing device 19, as shown in figure 1 and in the left part of figure 2.

[0020] In such a situation, the walls of the bag portion 5 arevkept spaced by the rigid tube 16 so as to form an empty space where there is provided only sterile air kept by the plug 17.

[0021] Having removed the closing cap 24, the device 19 is hooked to the closure plug 23 of a vial 22 containing an active substance 52 in form of powder, gel or liquid, with ensuing simultaneous piercing of the closure plug 23 through the bored stem 21, as shown in figure 3.

[0022] At that point, by compressing laterally with her / his hand the portion 3 of bag 2, the operator causes the opening of the hermetic transversal welding 7 (right part of figure 2), with ensuing passage of the liquid 51 from the top space 4 to the bottom space 6 of the bag 2, and from here into the vial 22, wherein its mixing with the active substance 52 occurs.

[0023] The apparatus 1 with relative vial 22 is then placed upside down with respect to the position shown in figures 1-3, so as to complete the transfer of the mixture inside the bag 2, that is so ready for administering the mixture to a patient.

[0024] The administration occurs by disconnecting the breakable closure plug 15 from the connector 14 and inserting in the connector 14 the connector of an IV administration set of any known type, as described in EP 4 000 679 Al .

Claims

CLAIMS1. Apparatus for reconstitution, withdrawal and administration of drugs or nutrients obtained from active substances in powder, liquid or gel form contained in vials or other containers with hermetic closure, comprising a sealed flexible bag (2) and a hooking and piercing device (19) which is hookable to the closure plug (23) of a vial (22) containing an active substance (52) in powder, liquid o gel form for simultaneous piercing of said plug (23), characterized in that said bag (2) is divided into two bag portions (3, 5), a first bag portion (3) having a first internal space (4) fillable with a sterile liquid sterile (51) and a second bag portion (5) having a second internal space (6) communicating with said hoking and piercing device (19), said bag portions (3, 5) being separated by a hermetic transversal welding (7) which prevents communication between the first internal and second internal spaces (4, 6) and is openable by compression of said first bag portion (3).

2. Apparatus according to claim 1, characterized in that said second bag portion (5) is provided with at least one divarication tube (16) which keeps spaced the walls of said second bag portion (5).

3. Apparatus according to claim 1 or 2, characterized in that said first bag portion (3) is provided with a connector (9) with a hermetic closure valve (10) which is openable by axial pressure and automatically hermetically reclosable when said pressure ceases.

4. Apparatus according to claim 1, 2 or 3, characterized in that said hooking and piercing device (19) comprises a hooking part (20) hookable to the closure plug (23) of a vial (22) and a piercing part (21) formed by an axially bored stem connected and communicating with the internal space (6) of said second bag portion (5).

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