EP1744717B1 - Syringe for medical interventions and kit for reconstituting extemporaneous substances, comprising said syringe - Google Patents

Abstract

The syringe (12) comprises a syringe body (18) with a passage (28) for the circulation of fluid defined therein, said circulatory passage (28) being extended by a main element (20) for fluidic connection to a complimentary volume (13), and a moveable piston (36) inside the body of the syringe (18) defining, with the aid of said syringe body (18), a chamber for the containment of fluid, opening out of said circulatory passage (28). The body of the syringe (18) defines a closed space in which the piston (36) is moveably mounted. The piston (36) also defines an auxiliary return chamber inside said closed space. The body of the syringe (18) defines a return passage (48) opening out into the auxiliary return chamber (46). The return passage (48) is extended by an auxiliary element (50) for connection to said complementary volume (13).

Description

The present invention relates to a syringe and a kit for reconstitution of extemporaneous substances comprising such a syringe, as known from the document US 5,643,218 .

• un corps de seringue dans lequel est délimité un passage de circulation d'un fluide, ce passage de circulation étant prolongé par un organe principal de connexion fluidique à un volume complémentaire, et
• un piston mobile dans le corps de seringue délimitant, avec le corps de seringue, une chambre de confinement du fluide, laquelle chambre de confinement s'ouvre par ledit passage de circulation.

In particular, the invention relates to a syringe, of the type comprising:

• a syringe body in which is delimited a circulation passage of a fluid, this circulation passage being extended by a main fluidic connection member to a complementary volume, and
• a piston movable in the syringe body delimiting, with the syringe body, a fluid confinement chamber, which containment chamber opens by said circulation passage.

In the medical field, it is known to use a syringe to ensure the reconstitution of an extemporaneous mixture consisting of a solvent and a cytotoxic active ingredient. The active ingredient is for example used for the chemotherapy treatment of patients with cancer.

As known per se, the solvent is commonly initially contained in an infusion bag, while the cytotoxic active ingredient, usually in powder form, is initially contained in a vial. For the preparation of the extemporaneous mixture, the practitioner takes solvent from the bag to introduce it into the body of a syringe. The solvent thus taken is introduced into the flask where it mixes with the powder constituting the active ingredient. The mixture thus reconstituted is re-aspirated into the syringe before being transferred back into the infusion bag. The latter is then placed on an infusion line to progressively administer its contents to the patient.

During successive transfers, the excess air contained in the bottle, during the introduction of the solvent, are discharged into the atmosphere through a vent provided for this purpose. The solvent vapors, and especially the gaseous fumes resulting from the active ingredient, escape through this vent. These can be dangerous for the medical staff performing this transfer. Thus, it is known to equip the vent with a filter having openings of 0.2 microns in order to retain the harmful molecules in the bottle.

However, the actual efficiency of such a filter is discussed and the implementation of this filter is delicate and expensive.

The object of the invention is therefore to propose a syringe that avoids such gaseous releases that may be harmful for medical personnel.

For this purpose, the invention relates to a syringe of the aforementioned type, characterized in that the syringe body delimits a closed space in which the piston is movably mounted, which piston defines in this enclosed space, in addition to the chamber of confinement of the fluid, an auxiliary return chamber, the syringe body delimiting a return passage opening in said auxiliary return chamber, and said return passage is extended by an auxiliary connecting member to said complementary volume.

• ledit organe auxiliaire de connexion comprend une aiguille creuse ;
• elle comporte une tige d'actionnement du piston liée au piston et faisant saillie hors du corps de seringue depuis une extrémité arrière, ledit passage de circulation étant formé à l'extrémité avant du corps de seringue, et ledit passage de rappel est formé au voisinage de l'extrémité arrière du corps de seringue et l'organe auxiliaire de connexion s'étend suivant la longueur du corps de seringue du passage de rappel au voisinage de l'extrémité avant ;
• l'organe principal de connexion fluidique comporte un distributeur comprenant une embase délimitant au moins trois voies de circulation et un obturateur mobile par rapport à l'embase, une première voie étant reliée audit passage de circulation, une seconde voie comportant un conduit de liaison audit volume complémentaire et une troisième voie comportant un conduit de transfert, ledit obturateur étant mobile entre une position de transfert dans laquelle les première et troisième voies sont reliées et une position de préparation dans laquelle les première et seconde voies sont reliées.
• le corps de seringue et le distributeur sont indissociables ;
• le conduit de transfert comporte une aiguille creuse ; et
• ladite aiguille creuse du conduit de transfert comporte un capuchon perforable et élastiquement déformable recouvrant l'aiguille creuse ;
• le conduit de liaison comporte une aiguille creuse ;
• les tronçons d'extrémités libres des aiguilles creuses de l'organe auxiliaire de connexion et du conduit de liaison sont distants de moins de 1 cm.

According to particular embodiments, the syringe comprises one or more of the following characteristics:

• said auxiliary connecting member comprises a hollow needle;
• it comprises an actuating rod of the piston connected to the piston and projecting out of the syringe body from a rear end, said circulation passage being formed at the front end of the syringe body, and said return passage is formed in the vicinity the rear end of the syringe body and the auxiliary connecting member extends along the length of the syringe body of the return passage in the vicinity of the front end;
• the main fluidic connection member comprises a distributor comprising a base defining at least three circulation lanes and a shutter movable relative to the base, a first lane being connected to said circulation passage, a second lane comprising a connection duct to said complementary volume and a third channel comprising a transfer conduit, said shutter being movable between a transfer position in which the first and third channels are connected and a preparation position in which the first and second channels are connected.
• the syringe body and the dispenser are indissociable;
• the transfer duct comprises a hollow needle; and
• said hollow needle of the transfer conduit comprises a perforable and elastically deformable cap covering the hollow needle;
• the connecting pipe comprises a hollow needle;
• the free end sections of the hollow needles of the auxiliary connection member and the connecting conduit are less than 1 cm apart.

The invention also relates to a reconstitution kit comprising a syringe as defined above and a complementary volume adapted for simultaneous connection to the confinement chamber and to the auxiliary return chamber respectively through the main organ of fluidic connection and the auxiliary connection member.

• la figure 1 est une vue en perspective éclatée d'un nécessaire de reconstitution comportant une seringue selon l'invention ; et
• les figures 2 à 6 sont des vues en coupe longitudinale du nécessaire à des stades successifs d'utilisation.

The invention will be better understood on reading the description which follows, given solely by way of example and with reference to the drawings, in which:

• the figure 1 is an exploded perspective view of a reconstitution kit comprising a syringe according to the invention; and
• the Figures 2 to 6 are views in longitudinal section of the necessary at successive stages of use.

The reconstitution kit 10 illustrated on the figure 1 is intended in particular for the extemporaneous preparation of a cytotoxic or other drug for the treatment by cancer chemotherapy or other.

This kit essentially comprises a syringe 12 and a bottle 13 initially comprising an active ingredient in powder form. This bottle 13 is formed, for example and as illustrated on the figure 4 , a body 14 of non-deformable glass closed by a lid 15, this body delimiting a closed space. It is initially filled with an active ingredient powder or liquid. The syringe 12 is able to be connected, on the one hand, to the bottle 13 and, on the other hand, to an infusion bag 16.

More specifically, the syringe 12 comprises a syringe body 18 carrying graduations 19 and a three-way dispenser 20 for selectively connecting a chamber of the syringe body selectively to the vial 12 or to the infusion bag 16.

As illustrated on Figures 2 to 6 , the syringe body 18 has a cylindrical wall 22 of generally circular section closed, at a front end, by a transverse wall 24 delimited by a base 26 of the distributor 20. This wall 24 is pierced with a passage 28 for circulation of a fluid entering or leaving the syringe.

The passage 28 is extended by a conduit 30 forming a first channel of the distributor 20. At the rear end of the syringe body 18, the cylindrical wall 22 is closed by a transverse wall 31 pierced at its center with an orifice 32 for the circulation of a piston rod 34.

The piston rod 34 is disposed along the axis of the syringe body and has, at its end received in the syringe body, a piston 36 movable axially from one end to the other of the syringe body and having a peripheral lip 38 sealing along the wall. At its end protruding from the syringe body, the piston rod 34 has a transverse bearing surface 38. An O-ring seal 40 is disposed against the transverse wall 31 at the periphery of the piston rod 34. seal is compressed by a support washer 42.

Thus, the piston 36 defines in the syringe body, at the front, a chamber 44 for confining the fluid. This chamber is generally closed and is open only through the circulation passage 28. On the other side of the piston 36 is defined an auxiliary chamber 46 for booster excess gas. The chambers 44 and 46 are complementary and together form an enclosed space delimited by the syringe body 18.

The auxiliary return chamber 46 is closed and opens only by a passage 48 for returning a gaseous excess. This passage is extended by an auxiliary member 50 for connection to the bottle 13.

The auxiliary connection member 50 is formed of a metal tube or of reduced section plastic material, for example of 0.5 mm internal diameter. This comprises a main rectilinear section 50A and two end sections 50B, 50C angled extend generally perpendicular to the main straight section 50A.

The rectilinear section 50A has a length very slightly greater than the length of the syringe body 18. The rear bent end 50B is engaged in the return passage 48.

The rectilinear main section 50A extends along the length of the cylindrical wall 22. For holding the tube 50, the syringe body has, on its outer surface, a channel 52 delimited by two longitudinal lips 54 visible on the figure 1 .

The curved end before 50C is tapered at its end denoted 50D, so that the auxiliary member 50 of connection constitutes a hollow needle. The tapered end 50D is adapted to engage through the perforable lid 15 closing the neck of the bottle 13.

The base 26 of the distributor 20 is formed for example of injected plastic.

The wall 24 forming the end of the syringe body is lined externally with a flange 60 allowing the cylindrical wall 22 to be secured. This joining is effected in an indissociable manner, for example by gluing or ultrasonic welding, so that the distributor can not be dissociated from the syringe body 18.

The base 26 defines a cylindrical seat 62 in which is received a slide valve 64 of the dispenser. This bushel passes through the base from one side to the other and is equipped at each end with an actuator 66,68.

In addition to the duct 30, two other ducts of the distributor open on the seat 62. The three ducts of the dispenser extend in the same plane and are angularly offset by 90 °, as shown in FIG. figure 2 .

A conduit 70 connecting the bottle 13 forms a second channel of the dispenser. It comprises a hollow needle 72 projecting from the base 26. The needle 72 extends parallel to the elbow 50C and is intended, like him, to enter the bottle 13 through the pierceable lid 15. The Beveled ends of the needles 50 and 72 are arranged in the vicinity of each other and are preferably spaced apart by less than 1 cm and preferably from 1 to 3 mm.

The base 26 has a collar 74 surrounding the projecting end of the needle 72. This collar defines a receiving space of the neck of the bottle 13 and has profiles 76 of elastic engagement behind the neck to ensure a mechanical connection of the bottle and dispenser.

The bent section 50C extends in the space delimited by the flange 74, the section 50C and the needle 72 extending parallel to each other for a perforation of the cover 15.

The third channel of the dispenser comprises a conduit 80 for transfer to the infusion bag 16. This conduit is provided with a hollow needle 82 projecting from the base 26, in a generally cylindrical socket 84 formed in the base and adapted to receive a nose 86 of the infusion bag 16.

As known per se, this nose 86 is generally cylindrical and is perforable to allow access to the pocket by an access conduit 88.

The protruding end of the needle 82 is covered over its entire length by a perforable elastic cap 90 in the form of bellows able to compress axially along the needle 82.

The plug 64 is rotatably mounted about its axis, the latter extending perpendicular to the plane in which the ducts 30, 70 and 80 extend.

A peripheral groove 92 is provided on the plug 64 to allow the selective connection of the ducts. This groove extends over 180 °. Thus, the plug is adapted to, in a first so-called transfer position, ensure the connection of the ducts 30 and 80, the duct 70 being closed and, in a second so-called preparation position, ensure the connection of the ducts 30 and 70, the led 80 being closed.

The reconstitution kit is used as follows.

Initially, the bag 16 and the bottle 13 are not connected to the syringe 12, as shown in FIG. figure 2 . The syringe is stored in sterile packaging.

After leaving the package, the syringe 12 is first connected to the pocket 16 from the needle 82. For this purpose, the nose 86 of the pocket is engaged in the base 84, so that the cap 90 is perforated. by the needle 82 and retracts along this needle. The beveled end of the needle 82 pierces the nose of the pocket and thus comes into contact with the solvent contained therein, as illustrated in FIG. figure 3 .

With the nozzle of the dispenser in its transfer position and connecting the conduits 30 and 80, the piston 36, initially pressed against the front wall 24, is pulled backwards. Under the action of the displacement of the piston 36, the solvent is progressively extracted from the pocket and is received in the confinement chamber 44, as shown in FIG. figure 3 . The air contained in the auxiliary chamber 46 is gradually evacuated through the auxiliary connection member 50. The air is released into the atmosphere, without consequence, this air being sterile.

After filling the chamber 44 with a satisfactory amount of solvent, the bottle 13 is connected. For this purpose, the neck of the bottle is introduced into the space delimited by the flange 74. The cover 15 is then perforated by both the needle 72 and the needle 50.

The plug 64 is then rotated 90 ° to be brought into its preparation position, so that the conduits 30 and 70 are connected to each other, the conduit 80 being isolated. In this position, the confinement chamber 44 is connected to the bottle 13 through the needle 72, while the auxiliary return chamber 46 is also connected to the bottle 13 by the auxiliary connecting member formed of the needle 50.

For proper operation, the bottle is placed with its neck pointing upwards and, as shown in figure 4 the piston is then pushed forward, leading to the expulsion of the solvent into the vial through, successively, ducts 30 and 70. Simultaneously, the excess gas contained in the vial 13 is sucked into the auxiliary booster chamber 46 through the needle 50. The excess gas contained in the bottle is transferred to the booster chamber under the combined action of the emerging pressure in the bottle 13 and under the action of the suction of the auxiliary chamber 46, due to the displacement of the piston 36.

All the solvent contained in the confinement chamber 44 is thus transferred to the bottle. The solvent then mixes with the powder constituting the cytotoxic active principle.

The bottle 13 is then inverted, so that the free end of the needle 72 is in contact with the mixture, as illustrated in FIG. figure 5 . The piston 36 is then moved towards the rear of the syringe body by traction on the rod 34, as illustrated on the figure 5 . The mixture is thus re-sucked into the confinement chamber 44 through, successively, conduits 70 and 30.

Simultaneously, the gas previously sucked into the auxiliary return chamber 46 is reintroduced into the bottle 13 to occupy the free space left by the mixture discharged to the confinement chamber 44.

All the mixture is thus re-sucked into the syringe. As illustrated on the figure 6 , the plug 64 is then returned to its transfer position, providing the connection between the ducts 30 and 80. The mixture contained in the confinement chamber 44 is then reintroduced to the pocket 16 through, successively, conduits 30 and 80 under the action of the piston 36 pushed axially towards the front of the syringe body. During this transfer, the bottle 13 remains connected and gas extracted from the bottle is sucked into the return chamber. Thus, a slight depression is created in the bottle 13.

After transfer of all the mixture contained in the confinement chamber 44 or a determined volume using the graduations of the syringe, the pocket 16 is separated from the syringe by disengaging the nose 86 from the base 84. action of the elasticity of the cap 90, it then relaxes along the needle 82 to completely cover the end thereof. Thus, the mixture still contained in the needle is confined within the cap 90, avoiding any transfer of mixture in liquid and gaseous form to the outside.

With such a device, no gaseous release containing molecules of the cytotoxic active ingredient is released into the atmosphere. Indeed, the gas emissions that can take place in the bottle during the reconstitution of the extemporaneous mixture during the various phases of use of the syringe are systematically confined in the bottle and / or in the auxiliary booster chamber 46. The bottle 14 and the syringe 46 remaining permanently secured, no contact between the interior of the bottle and the chamber 46 with the outside takes place.

It is conceivable that with such a device, the operator is protected against possible pollution resulting from the use of the cytotoxic active ingredient.

Claims (10)

1. A syringe (12) comprising:

   - a syringe body (18) in which is defined a fluid circulation passage (28), said circulation passage (28) being extended by a main member (20) for fluid connection to a supplementary volume (13), and

   - a movable piston (36) in the syringe body (18) bounding, with the syringe body (18), a fluid-containing chamber (44), which fluid-containing chamber (44) opens through said circulation passage (28),

   characterised in that the syringe body (18) bounds a closed space (44,46) in which the piston (36) is mounted for movement, which piston (36) bounds in this closed space, in addition to the fluid-containing chamber (44), an auxiliary return chamber (46), the syringe body (18) bounding a return passage (48) opening into said auxiliary return chamber (46), and in that said return passage (48) is extended by an auxiliary member (50) connecting to said supplementary volume (13).
2. A syringe according to Claim 1, characterised in that said auxiliary connecting member comprises a hollow needle (50).
3. A syringe according to Claim 1 or 2, characterised in that it comprises a piston-actuating rod (34) connected to the piston (36) and projecting outside the syringe body (18) from a rear end, said circulation passage (28) being formed at the front end of the syringe body (18), and in that said return passage (48) is formed in the vicinity of the rear end of the syringe body (18) and the auxiliary connecting member (50) extends along the length of the syringe body (18) of the return passage (48) in the vicinity of the front end.
4. A syringe according to any one of the preceding Claims, characterised in that the main fluid connection member comprises a distributor (20) which includes a base (26) delimiting at least three circulation ducts and a valve (64) movable in relation to the base (26), a first duct (30) being connected to the circulation passage (28), a second duct comprising a conduit (70) for connection to said supplementary volume (13) and a third duct comprising a transfer conduit (80), said valve being movable between a transfer position, in which the first and third ducts are connected, and a preparation position in which the first and second ducts are connected.
5. A syringe according to Claim 4, characterised in that the syringe body (18) and the distributor (20) cannot be separated.
6. A syringe according to claim 4 or 5, characterised in that the transfer conduit (80) comprises a hollow needle (82).
7. A syringe according to Claim 6, characterised in that said hollow needle (82) of the transfer conduit comprises a perforable and elastically deformable cap (90) covering the hollow needle (82).
8. A syringe according to any one of Claims 4 to 7, characterised in that the connecting conduit (70) comprises a hollow needle (72).
9. A syringe according to any one of Claims 2 and 8 taken together, characterised in that the free end sections of the hollow needles (50,72) of the auxiliary connecting member (50) and of the connecting conduit (70) are spaced apart by at least 1 cm.
10. A reconstitution kit comprising a syringe (12) according to any one of the preceding Claims, and a supplementary volume (13) adapted for simultaneous connection to the fluid-containing chamber (44) and to the auxiliary return chamber (46) respectively through the main fluid connection member (20) and the auxiliary connecting member (50).

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