Hermetic closing plug for a sealed sterile vial containing medical or nutritional active substances, suitable for the sterile connection to a container of liquid diluent solution, and sterile connection system using said closing plug

Abstract

A closing plug for a sealed sterile vial containing medical or nutritional active substances, which is suitable for the sterile connection to a container of liquid diluent solution. There is also described a sterile connection system between a sealed sterile vial closed by means of a plug and a tube for drawing said active substances, for mixing them with a liquid diluent solution inside a sterile container. The plug requires an internal sterile chamber in which, upon the piercing of an outer film for sealing the plug, a compressible protection cap of a piercing tip of the tube is inserted, which abuts against a seat of the sterile chamber allowing the tip to pierce the end wall of the protection cap and then the inner membrane of the closing plug. An intermediate pierceable membrane placed on the seat of the internal chamber of the vial may be included.

Claims

1. A sterile connection system between an internal sterile chamber of a vial for containing medical or nutritional active substances and a tube for drawing said active substances and mixing them with a liquid diluent solution maintained in sterile conditions in a container, wherein: the vial has a head provided with a hermetic closing plug of a pierceable plastic material on which an outer pierceable sealing film or membrane is placed which is capable of maintaining the closing plug in sterile conditions; the tube has a hollow piercing tip which extends coaxially inside a terminal for attachment to the head of the vial and is provided with a compressible protection cap able to keep said piercing tip in sterile conditions; wherein said compressible protection cap is made of axially compressible material with such a compression resistance to allow the compressible protection cap to pierce said outer sealing film or membrane of the closing plug of the vial in a first advancement step of the terminal of the tube to the head of the vial; said closing plug is made of a plastic material having a higher rigidity than said compressible protection cap and has an internal sterile chamber located between said outer sealing film or membrane and an inner pierceable membrane arranged to close hermetically the internal sterile chamber of the vial; said internal sterile chamber of the closing plug includes a seat for abutment of the end of said compressible protection cap in a second step of advancement of the terminal of the tube to the head of the vial after piercing of the outer sealing film or membrane of the closing plug and a passage of communication with said inner pierceable membrane to allow, in a final step of hooking of the terminal of the tube to the head of the vial, axial compression of said compressible protection cap and further advancement of said piercing to pierce the end of said compressible protection cap and then said inner piercable membrane of the closing plug of the vial to put in sterile communication the internal sterile chamber of the vial and said tube.

2. The sterile connection system according to claim 1, wherein said closing plug of the vial comprises a further internal or intermediate pierceable membrane placed on said seat of the internal sterile chamber of the closing plug.

3. The sterile connection system according to claim 1, wherein said plastic material of said closing plug is a thermoplastic material.

4. The sterile connection system according to claim 3, wherein said internal pierceable membrane is in one piece with the closing plug.

5. The sterile connection system according to claim 1, wherein said outer sealing film or membrane of the closing plug is made of medical paper, thermoplastic material, rubber, silicone, or thin aluminum in one piece with the closing plug.

6. The sterile connection system according to claim 1, wherein said compressible protection cap of the piercing tip of the tube is made of rubber or silicone with a pierceable end wall.

7. The sterile connection system according to claim 2, wherein said further internal or intermediate pierceable membrane is made of medical paper, thermoplastic material, rubber, silicone, or thin aluminum, in one piece with the closing plug.

Description

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

(1) The features of the present invention will become more apparent by means of the following detailed description of two practical embodiments shown by way of example in the accompanying drawings, in which:

(2) FIG. 1 shows, as a whole and in rest conditions, a sterile connection system according to the present invention between an active substance vial provided with a closing plug according to the present invention and a tube for drawing and mixing said active substances with a liquid diluent solution;

(3) FIGS. 2-4 sequentially show the steps of attaching and piercing the closing plug of the vial;

(4) FIG. 5 shows, as a whole and in rest conditions, a variant of the sterile connection system according to the present invention, in which the closing plug of the vial is provided with an inner protection membrane or intermediate membrane made of a pierceable material;

(5) FIGS. 6-9 sequentially show the steps of attaching and piercing the closing plug of the vial according to the variant in FIG. 5.

DETAILED DESCRIPTION OF THE INVENTION

(6) FIG. 1 shows the portion of head of a vial 1 with an internal sterile chamber 2 for containing medical or nutritional active substances. Vial 1 is hermetically closed with a closing plug 3 made of a thermoplastic material over which a thin outer sealing film or membrane 4 made of medical paper, thermoplastic material, rubber, silicone, thin aluminum or other suitable easily pierceable material is placed and fixed, possibly in one piece with the closing plug (3).

(7) The closing plug 3 has an internal sterile chamber 5 between the outer sealing film or membrane 4 and an inner pierceable membrane 6, in one piece with the rest of plug 3, which is arranged to close the lower end of a passage 7 of communication between the internal sterile chamber 5 of plug 3 and the internal sterile chamber 2 of vial 1. An annular face or seat 8 surrounds the upper end of passage 7.

(8) FIG. 1 also shows the attachment terminal or portion 9 of a drawing and mixing tube 10 which extends from a conventional bag or other container for sterilely housing a liquid diluent solution (not seen in the drawing). Inside the attachment terminal 9, the drawing and mixing tube 10 ends with a hollow piercing tip 11 in communication with the tube itself. The piercing tip 11 is protected in a sterile manner by a cylindrical cap 12 made of an axially compressible material capable of piercing the outer sealing film or membrane 4 but not the thermoplastic material of plug 3. The protection cap 12 is closed at the bottom by a pierceable end wall 13, surrounded by an annular projection 14.

(9) The assembly in FIG. 1 allows the sterile connection between the internal chamber 2 of the vial and the internal chamber (not shown) of the container of liquid diluent solution as described below with reference to FIGS. 2, 3 and 4.

(10) In a first operating step (FIG. 2), the attachment terminal 9 of the drawing and mixing tube 10 is brought forward but not yet attached to the head of vial 1. The advancement determines the piercing of the outer sealing film or membrane 4 by the protection cap 12, the end thereof penetrates into the inner sterile chamber 5 of plug 3 until it abuts, without compressing, against the annular projection 14 thereof on the annular face or seat 8 of said sterile chamber.

(11) Continuing the advancement of the attachment terminal 9 towards the head of the vial (FIG. 3), the protection cap 12 of the piercing tip 11 axially compresses due to the abutment thereof with the annular face or seat 8, allowing the piercing tip 11 to pierce the end wall 13 of the protection cap 12 and enter the passage 7 which leads to the inner protection membrane 6 of plug 3.

(12) When the attachment terminal 9 attaches to the head of vial 1 (FIG. 4), the protection cap 12 is further compressed and the piercing tip 11 penetrates through the inner membrane 6, thus putting the internal chamber of vial 1 in sterile communication with the interior of the drawing and mixing tube 10, and therefore with the internal sterile chamber of the container of liquid diluent solution.

(13) As described and shown in FIGS. 2-4, it is apparent that the whole operation of attaching and putting into communication takes place without any loss of sterility.

(14) The assembly in FIG. 5 is the same as that in FIG. 1 except that a further internal protection membrane or intermediate membrane 15 is provided, made of a pierceable material, for example medical paper, thermoplastic material, rubber, silicone, thin aluminum or other suitable easily pierceable material, possibly in one piece with the closing plug (3). The intermediate membrane 15 is placed on the annular face or seat 8.

(15) In this case, upon the piercing of the outer sealing film or membrane 4, the annular projection 14 of the terminal end of the protection cap 12 abuts against the intermediate membrane 15 (FIG. 6) and, continuing the advancement of the attachment terminal 9 towards the head of vial 1, axially compresses' and is then pierced by the piercing tip 11, which continues piercing the intermediate membrane 15 and then the internal membrane 6 as shown in FIGS. 7, 8 and 9.

(16) Also in this case, the whole operation of attaching and putting into communication takes place without any loss of sterility.