EP1744717A1

EP1744717A1 - Syringe for medical interventions and kit for reconstituting extemporaneous substances, comprising said syringe

Info

Publication number: EP1744717A1
Application number: EP05763666A
Authority: EP
Inventors: Jean-Pascal Delay
Original assignee: Sedat SAS
Current assignee: Sedat SAS
Priority date: 2004-05-03
Filing date: 2005-04-27
Publication date: 2007-01-24
Anticipated expiration: 2025-04-27
Also published as: FR2869533B1; US7896849B2; FR2869533A1; WO2005120431A1; DE602005009521D1; EP1744717B1; US20080009790A1

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

Syringe for medical procedures and necessary for the reconstitution of extemporaneous substances comprising such a syringe.

The present invention relates to a syringe and a kit for reconstituting extemporaneous substances comprising such a syringe. In particular, the invention relates to a syringe, of the type comprising: - a syringe body in which a passage for circulating a fluid is delimited, this circulation passage being extended by a main fluid connection member to an additional volume , and - a piston movable in the syringe body delimiting, with the syringe body, a fluid confinement chamber, which confinement chamber opens through 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 principle. The active principle is for example used for the treatment by chemotherapy of patients suffering from cancer. As known per se, the solvent is commonly initially contained in an infusion bag, while the cytotoxic active ingredient, generally 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 withdrawn is introduced into the bottle where it mixes with the powder constituting the active principle. The mixture thus reconstituted is re-aspirated into the syringe, before being transferred back to the infusion bag. The latter is then placed on an infusion line to gradually administer its contents to the patient. During successive transfers, the excess air contained in the flask, during the introduction of the solvent, is discharged into the atmosphere by 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 personnel carrying out this transfer. Thus, it is known to equip the vent with a filter having openings of 0.2 μm in order to retain, in the bottle, the harmful molecules. However, the real effectiveness of such a filter is discussed and the implementation of this filter is delicate and costly. The object of the invention is therefore to propose a syringe avoiding such gaseous releases which may be harmful to medical personnel. To this end, the subject of the invention is a syringe of the aforementioned type, characterized in that the syringe body delimits an enclosed space in which the piston is movably mounted, which piston delimits in this enclosed space, in addition to the fluid confinement chamber, an auxiliary return chamber, the syringe body delimiting a return passage opening in said auxiliary return chamber, and that said return passage is extended by an auxiliary member for connection to said complementary volume. According to particular embodiments, the syringe comprises one or more of the following characteristics: - said auxiliary connection member comprises a hollow needle; - It comprises a piston actuating rod linked to the piston and projecting from 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 at near the rear end of the syringe body and the auxiliary connection member extends along the length of the syringe body of the return passage in the vicinity of the front end; - The main fluid connection member comprises a distributor comprising a base delimiting at least three circulation paths and a shutter movable relative to the base, a first path being connected to said circulation passage, a second path comprising a connecting conduit said additional volume and a third channel comprising a transfer duct, 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 inseparable; - the transfer duct comprises a hollow needle; and - said hollow needle of the transfer duct comprises a perforable and elastically deformable cap covering the hollow needle; - The connecting conduit comprises a hollow needle; - the free end sections of the hollow needles of the auxiliary connection member and of the connecting duct are spaced less than 1 cm apart. The subject of the invention is also a reconstitution kit comprising a syringe as defined above and an additional volume suitable for simultaneous connection to the confinement chamber and to the auxiliary booster chamber respectively through the main organ of fluid connection and the auxiliary connection member. The invention will be better understood on reading the description which follows, given solely by way of example and made with reference to the drawings, in which: - Figure 1 is an exploded perspective view of a reconstruction kit comprising a syringe according to the invention; and - Figures 2 to 6 are views in longitudinal section of the kit at successive stages of use. The reconstruction kit 10 illustrated in FIG. 1 is intended in particular for the extemporaneous preparation of a cytotoxic or other drug for the treatment by cancer chemotherapy or the like. This kit essentially comprises a syringe 12 and a vial 13 initially comprising an active principle in the form of powder. This bottle 13 is formed, for example and as illustrated in FIG. 4, of a body 14 of non-deformable glass closed by a cover 15, this body delimiting an enclosed space. It is initially filled with an active principle in powder or liquid. The syringe 12 is suitable for being 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 dispenser three ways 20 allowing the selective connection of a chamber of the syringe body selectively to the bottle 12 or to the infusion bag 16. As illustrated in FIGS. 2 to 6, the syringe body 18 comprises a cylindrical wall 22 of generally circular section closed at one front end by a transverse wall 24 delimited by a base 26 of the dispenser 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 dispenser 20. At the rear end of the syringe body 18, the cylindrical wall 22 is closed by a transverse wall 31 pierced in 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 which can be moved axially from one end to the other of the syringe body and having a peripheral lip 38 ensuring sealing along the wall. At its end projecting 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. This seal is compressed by a support washer 42. Thus, the piston 36 delimits in the syringe body, at the front, a chamber 44 for confining the fluid. This chamber is generally closed and is only open via the circulation passage 28. On the other side of the piston 36 is defined an auxiliary chamber 46 for booster gas excess. 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 recalling an excess of gas. This passage is extended by an auxiliary member 50 for connection to the bottle 13. The auxiliary connection member 50 is formed from a metal or plastic tube of reduced section, for example 0.5 mm inside diameter. This comprises a main rectilinear section 50A and two bent end sections 50B, 50C generally extend perpendicular to the main rectilinear section 50A. The straight 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 main straight section 50A extends along the length of the cylindrical wall 22 To maintain the tube 50, the syringe body pre- feels, on its outer surface, a channel 52 delimited by two longitudinal lips 54 visible in FIG. 1. The front curved end 50C is bevelled at its end denoted 50D, so that the auxiliary connection member 50 constitutes a hollow needle . The beveled end 50D is suitable for engaging through the perforable cap 15 closing the neck of the bottle 13. The base 26 of the dispenser 20 is formed for example from injected plastic. The wall 24 forming the end of the syringe body is bordered on the outside by a flange 60 allowing the cylindrical wall 22 to be joined. This joining is carried out inseparably, for example by gluing or ultrasonic welding, so that the dispenser cannot be dissociated from the syringe body 18. The base 26 defines a cylindrical seat 62 in which a sliding plug 64 is received from the dispenser. This plug crosses the base from side to side and is equipped, at each end, with an operating member 66, 68. In addition to the duct 30, two other ducts of the distributor open onto the seat 62. The three ducts of the distributor s 'extend in the same plane and are angularly offset by 90 °, as illustrated in Figure 2. A conduit 70 for connection to the bottle 13 forms a second channel of the dispenser. It comprises a hollow needle 72 protruding from the base 26. The needle 72 extends parallel to the bent section 50C and is intended, like him, to enter the bottle 13 through the perforable cap 15. The beveled ends of needles 50 and 72 are arranged in the vicinity of one another and are preferably spaced less than 1 cm and preferably 1 to 3 mm. The base 26 has a collar 74 surrounding the projecting end of the needle 72. This collar defines a space for receiving the neck of the bottle 13 and comprises 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 way of the dispenser comprises a conduit 80 for transfer to the infusion bag 16. This conduit is provided with a hollow needle 82 projecting relative to the base 26, in a generally cylindrical base 84 formed in the base and suitable for receiving 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 bag by an access duct 88. The projecting end of the needle 82 is covered on its entire length by an elastic perforable cap 90 in the form of a bellows capable of being compressed axially along the needle 82. The plug 64 is mounted to rotate about its axis, the latter extending perpendicular to the plane in which s '' expand conduits 3 0, 70 and 80. A peripheral groove 92 is provided on the plug 64 to allow the selective connection of the conduits. This groove extends over 180 °. Thus, the plug is suitable for, in a first so-called transfer position, ensuring the connection of the conduits 30 and 80, the conduit 70 being closed and, in a second so-called preparation position, ensuring the connection of the conduits 30 and 70, the conduit 80 being closed. The reconstitution kit is used as follows. Initially, the bag 16 and the bottle 13 are not linked to the syringe 12, as illustrated in FIG. 2. The syringe is stored in a sterile packaging. After removal from the packaging, 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 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 in it, as illustrated in FIG. 3. The valve of the distributor being in its transfer position and connecting the conduits 30 and 80, the piston 36, initially pressed against the front wall 24, is pulled back. Under the action of the displacement of the piston 36, solvent is gradually extracted from the bag and is received in the confinement chamber 44, as illustrated in FIG. 3. The air contained in the auxiliary chamber 46 is gradually evacuated through the auxiliary connection member 50. The air is discharged 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 collar 74. The cover 15 is then perforated both by the needle 72 and by the needle 50. The plug 64 is then turned 90 ° to be brought into its preparation position, so that the conduits 30 and 70 are connected to each other, the conduit 80 being insulated. 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 connection member formed by the needle 50. For correct operation, the bottle is placed with its neck facing upwards and, as illustrated in FIG. 4, the piston is then pushed forward, leading to the expulsion of the solvent towards the inside of the bottle through , successively, conduits 30 and 70. Simultaneously, the excess gas contained in the bottle 13 is drawn into the auxiliary return chamber 46 through the needle 50. The excess gas contained in the bottle is transferred to the return chamber under the combined action of the overpressure emerging 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 so transferred to the bottle. The solvent then mixes with the powder constituting the active cytotoxic principle. The vial 13 is then inverted, so that the free end of the needle 72 is in contact with the mixture, as illustrated in FIG. 5. The piston 36 is then moved towards the rear of the syringe body by traction on the rod 34, as illustrated in FIG. 5. The mixture is thus re-aspirated into the confinement chamber 44 through, successively, the conduits 70 and 30. Simultaneously, the gas previously aspirated in the auxiliary return chamber 46 is reintroduced into the bottle 13, to occupy the space left free by the mixture discharged towards the confinement chamber 44. All the mixture is thus re-aspirated into the syringe. As illustrated in FIG. 6, the plug 64 is then returned to its transfer position, ensuring the connection between the conduits 30 and 80. The mixture contained in the confinement chamber 44 is then reintroduced towards 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 drawn 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 of a volume determined using the graduations of the syringe, the bag 16 is separated from the syringe by release of the nose 86 out of the base 84. Under the action of the elasticity of the cap 90, the latter then relaxes along the needle 82 to completely cover the end of the latter. Thus, the mixture still contained in the needle is confined inside 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 active cytotoxic principle is released into the atmosphere. In fact, the gassing 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 inside of the vial and the chamber 46 with the outside takes place. It is understood that with such a device, the operator is protected against possible pollution resulting from the use of the cytotoxic active principle.

Claims

CLAIMS 1.- Syringe (12) comprising: - a syringe body (18) in which a passage (28) for circulating a fluid is delimited, this passage (28) for circulation being extended by a main member (20) fluid connection to a complementary volume (13), and - a movable piston (36) in the syringe body (18) delimiting, with the syringe body (18), a chamber (44) for confining the fluid, which chamber containment (44) opens through said circulation passage (28), characterized in that the syringe body (18) delimits an enclosed space (44, 46) in which the piston (36) is movably mounted, which piston (36) delimits in this closed space, in addition to the chamber (44) for confining the fluid, an auxiliary return chamber (46), the syringe body (18) defining a return passage (48) s' opening in said auxiliary return chamber (46), and in that said return passage (48) is extended by an auxiliary member (50) of conn exion to said additional volume (13). 2. A syringe according to claim 1, characterized in that said auxiliary connection member comprises a hollow needle (50). 3. A syringe according to claim 1 or 2, characterized in that it comprises a rod (34) for actuating the piston linked to the piston (36) and projecting out of 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 connection member (50) extends along the length of the syringe body (18) of the return passage (48) in the vicinity of the front end. 4.- Syringe according to any one of the preceding claims, characterized in that the main fluid connection member comprises a distributor (20) comprising a base (26) delimiting at least three circulation paths and a movable obturator (64) with respect to the base (26), a first channel (30) being connected to said circulation passage (28), a second channel comprising a connecting duct (70) to said complete volume mentaire (13) and a third channel comprising a transfer duct (80), 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. 5. A syringe according to claim 4, characterized in that the syringe body (18) and the dispenser (20) are inseparable. 6. A syringe according to claim 4 or 5, characterized in that the transfer duct (80) comprises a hollow needle (82). 7. A syringe according to claim 6, characterized in that said hollow needle (82) of the transfer duct comprises a cap (90) which can be perforated and elastically deformable covering the hollow needle (82). 8.- Syringe according to any one of claims 4 to 7, characterized in that the connecting conduit (70) comprises a hollow needle (72). 9. A syringe according to claims 2 and 8 taken together, characterized in that the sections of free ends of the hollow needles (50, 72) of the auxiliary connection member (50) and of the connecting conduit (70) are spaced less than 1 cm apart. 10.- Reconstitution kit comprising a syringe (12) according to any one of the preceding claims, and an additional volume (13) suitable for simultaneous connection to the confinement chamber (44) and to the auxiliary booster chamber (46 ) respectively through the main fluid connection member (20) and the auxiliary connection member (50).