FR2746653A3 - SYRINGE FOR MEDICAL USE - Google Patents

Abstract

The present invention relates to a double-chamber glass syringe, the cylinder of which has a by-pass region in the form of an overflow identation in point or channel form inside the cylinder or in the form of several symmetrically arranged channel-like overflow indentations formed inside the cylinder, with a Luer adapter which can be fitted on the glass cylinder neck, consisting of a guide and holder, a Luer cone with a guide and a bottom-fitted spike and an outer closure into which a Luer closing cap is integrated.

Description

I

SYRINGE FOR MEDICAL USE

  Biotechnical preparations often have to be lyophilized for reasons of stability. Before use, a product thus lyophilized must be dissolved in a solvent which is supplied in a separate container and transferred to the freeze-drying container before use. This operation is logistically complicated and constitutes additional work when preparing an injection. In addition, the risk of contamination of the product with particles and agents

pathogens is greatly increased.

  To facilitate application, it is possible to use, for example, two-chamber syringes, instead of the conventional vial / ampoule system. For these two-chamber syringes, syringe ampoules are known which comprise a first movable piston to separate the two chambers and a second movable piston to produce the pressure necessary to evacuate the contents of the syringe outside, as well as a bulge of overflow starting at the end of the anterior chamber located on the side of the piston and continuing in

  back along the outer wall of the bulb body.

  However, this system has major drawbacks.

  The bulging of the wall poses problems in handling the syringe during the operations which must be carried out for hygienic pretreatment, filling and hermetic closure. So is

even for packaging.

  In addition, the area available for marking is limited due to this bulge. Consequently, the possibilities for providing clear product information and designations are very limited. US Patent No. 4,439,184 proposes a system which solves these problems. This system is a two-chamber plastic syringe which, in place of the outwardly facing overflow bulge mentioned above, has one or more solid or massive protuberances, in the form of an edge or edge, arranged parallel to the 'axis of the body, in a region or zone called bypass or bypass on the inside of the bulb body. If the first piston made of elastic material which separates the two chambers is moved into the bypass area, these protrusions cause the piston to move away from the body wall in the region surrounding these protrusions so that it forms along of these protuberances vanishing points analogous to channels through which a liquid contained in the chamber located behind the first piston can flow into the anterior chamber. The system described in US Pat. No. 4,439,184 is used in urology and is not intended to constitute a

  injection syringe because it has neither a Luer cone nor a needle.

  In addition, in many cases, for reasons of stability, it is not possible to use a primary plastic container. However, the injection ampoule contemplated in US Pat. No. 4,439,184 cannot be made of glass with the dimensional precision necessary at a reasonable cost, because glass cannot

to be molded.

  Therefore, the object of the present invention is to provide a syringe for medical use with two chambers of the type described above in such a way that it can be used in the manner described, while avoiding the drawbacks mentioned. above, and at the same time has the properties necessary for the stability of the drugs to be able to be used as

  primary packaging container.

  According to the present invention, this object is achieved by means of an injection syringe consisting of a syringe body having a glass wall, an extension formed on the end of the syringe body for sealing and support of the rims as in conventional bottles, a Luer adapter which can optionally also be mounted on this extension, and two pistons of elastic material, preferably rubber, movable longitudinally and arranged inside the syringe body, the inside of the syringe body being subdivided into an anterior chamber and a posterior chamber by the arrangement of the first piston substantially in the center of the syringe body, the second piston, disposed at the end of the posterior chamber, serving to generate the pressure necessary to empty the contents of the syringe, while the part of the wall of the syringe body starting at the end of the anterior chamber situated at the nive au of the first piston has a region of

  workaround which will be defined below.

  In a first embodiment, the syringe body has only an overflow projection formed inside the anterior chamber and which, according to a first variant, is in the shape of a point and consists, for example, of a lug turned towards inside the anterior chamber of the syringe body. In a second variant of this embodiment, the overflow projection is in the form of a channel and extends parallel to the axis of the syringe body, inside the chamber, the maximum longitudinal extent of the projection channel-shaped overflow in the direction of the axis of the body depending on the dimensions of the first piston or central piston, while the longitudinal extent can vary freely between that

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  of the first tip-shaped variant, which constitutes the lower limit, and an upper limit which is equal to the corresponding longitudinal extent of the first piston. For example, the longitudinal extent of the channel-shaped overhang projection is 0.3 to 0.8 times the length of the first piston in the direction of the body axis, but preferably it is equal to 0, 5 times this length. Particularly preferred is the shaped projection

peak.

  If the first piston of elastic material which separates the two chambers is moved in the bypass area, the overhang projection in this first embodiment causes the piston to tilt, so that it forms in the region opposite to the overflow projection a vanishing point (bypass) through which a liquid contained in the chamber behind the first

  piston can flow into the anterior chamber.

  In the second embodiment, the syringe body has a plurality of overflow projections arranged regularly along the circumference of the glass syringe body, which are in the form of channels parallel to the axis of the body inside the chamber and whose longitudinal dimensions must be adapted to the dimensions of the central piston in the direction of the axis of the body so that their longitudinal extent is generally equivalent to 0.8 to 1.2 times, preferably 1.0 to 1.2 times, the corresponding longitudinal extent

piston.

  The number of overhang projections in the second embodiment can vary between 2 and 6. Preferably, however, in this embodiment, the syringe according to the invention has two symmetrically opposite overhang projections to prevent the piston from

  bow, unlike the first embodiment.

  If the first piston made of elastic material which separates the two chambers is moved into the bypass area, the overhang projections in this second embodiment raise the piston and move it away from the body wall in the region surrounding the protuberances formed by overflow projections, so that vanishing points (bypasses) similar to channels form along these protuberances through which a liquid contained in the chamber behind the first piston can flow into the anterior chamber . The mode of operation of the channel-shaped overhang projections in this embodiment is the same as that described for the solid or

  massive described in US Pat. No. 4,439,184 mentioned above

above.

  To avoid damage to the pistons, the overhang projections are preferably rounded in

  the two embodiments described.

  In addition, the shape of the central piston is preferably such that its side facing the outlet of the syringe is adapted to the shape of the shoulder of the syringe body and of the closure cap so that substantially no residue remains. liquid in the syringe when

this is used.

  The invention also relates to a Luer adapter which can be mounted on the end of the syringe body and which can, for example, be designed as a closure for standard bottle or bottle necks of 13 mm or 20 mm.

mm according to DIN ISO 8362.

  The Luer adapter according to the invention consists of three separate parts which can be assembled, hereinafter called first part, second part and third part. The three parts are preferably all made of plastic which can be sterilized by

gamma rays.

  The first part is a guide member with socket or support which consists of a lower part in the form of a snap-on cover designed to fit on the fixing extension situated at the end of the syringe body and to be mounted on this extension , with a central round opening on the upper side to allow the passage of the tip of the second part during use, and in an upper part secured to the previous one, which is in the form of a guide sleeve intended to receive the second part and which is mounted in a centered manner on the lower part. In addition, the first part has a locking ring which is molded at the outer edge on the top of the lower part by means of a plurality of connecting ribs and which, when pushed on the sleeve, serves for fixing after the first part has been mounted on the extension located at the end

of the syringe body.

  The socket preferably consists of a slotted ring located at the lower end of the lower part to facilitate mounting on the extension located at the end of the syringe body or on a neck

of appropriately shaped bottle.

  In a first embodiment, the guide sleeve has inside a Luer blocking thread with two integrated circular blocking projections, located one above the other and which prevent accidental movement of the second part. inserted in the initial position, and a wedge-shaped annular blocking element provided below the Luer blocking thread to keep the second part inserted in the final position. In a second embodiment, the guide sleeve has only a wedge-shaped annular blocking element situated below the Luer blocking thread and which prevents accidental movement of the second part inserted in the initial position and in the

final position.

  In either case, this blocking element can fulfill its function for example by penetrating into a first annular channel located in the guide element of the second part and, after the second part has been brought into its final position, keeping it in this position by entering a second channel located

  also in the guide element of the second part.

  The second part consists of a Luer cone which has a guide element and a tip mounted at the bottom and which is crossed by a cavity through which the liquid can exit the syringe. The guide element may have first and second superimposed channels into which the wedge-shaped blocking element of the first part can penetrate. The second part is the mobile part of the Luer adapter. It is possible, for example, to mount conventional cannulas on the Luer cone. During use, the point can be used to pierce a closure plug in the extension located at

the end of the syringe body.

  The third part consists of an external closure cap in which a Luer closure cap is integrated. The external closure cap is designed so that its internal radius coincides with the dimensions of the guide sleeve of the first part. On the inside of the lower edge of the external closure cap, protuberances are provided, for example in the form of saw teeth arranged around the entire circumference, to ensure a close fit and a

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  solid support. The closure cap closes the closure

  waterproof and sterile system until the moment of use.

  The first to third parts are combined to form the Luer adapter according to the invention, by inserting the second part with the tip down into the guide member of the first part and then placing the closure cap of the third part. The Luer adapter is mounted on the extension located at the end of the syringe body or on any other bottle neck of suitable shape and it is fixed in this position by moving the locking ring down. By applying pressure to the closing cap (third part) during use, the Luer cone with the point (second part) moves downwards and the point is pushed through the closing cap, which opens a passage for the contents of the syringe. After the closure cap (third part) has been removed, a cannula, for example, can be inserted and

administration can begin.

  The invention is described more precisely below with the aid of an exemplary embodiment which refers

in Figures 1 to 5.

Example:

  FIG. 1 shows in longitudinal section an example of a first embodiment of a syringe body according to the invention, the bypass of which is formed inside the syringe body by a single overhanging projection in the form of a channel 5a parallel to its axis

or a lug 5b.

  FIG. 2 shows in longitudinal section a second embodiment of a syringe body according to the invention, the bypass of which is formed by two overhanging projections 5c in the form of a channel located inside the anterior chamber parallel to the axis

of the syringe body.

  FIG. 3 represents a cross section of the embodiment shown in FIG. 2 at the level of the overhang projections. FIGS. 4A to 4D represent the components of the Luer adapter consisting of three parts which is preferably used: FIG. 4A represents the first part of the Luer adapter in longitudinal section: guide member with socket, FIG. 4B represents the first part of the Luer adapter in bottom view, Figure 4C represents the second part of the Luer adapter in longitudinal section: Luer cone with tip, Figure 4D represents the third part of the Luer adapter in longitudinal section: cap closing. FIG. 5 represents the three parts of FIGS. 4A to 4D in the form of a fully assembled Luer adapter, which occupies the following positions: A: mounting position B: locked position on the extension of the syringe body C: activated position The syringe with medical use shown in Figure 1 comprises a syringe body 2 having a mouth formed at the anterior end and intended to be closed by a lyophilization plug 7 and a conventional flange cap 1. At the other end there is a support 6 for the fingers. The syringe has two chambers which are separated by a sealed intermediate piston 3. At the end of the anterior chamber situated on the side of the piston 3 there is provided a channel-shaped overflow projection 5a which is formed parallel to the axis of the syringe body, inside the chamber, and the length of which in the direction of the axis of the body is equal to 50% of the longitudinal extent of the piston 3, or a projection in the form of a pin 5b which is directed to

inside the room.

  The syringe shown in FIG. 2 differs from the embodiment described in FIG. 1 only by the overhang projection. At the end of the anterior chamber situated on the side of the piston 3 there are provided two opposite and parallel overflow projections 5c which extend in the direction of the freeze-drying plug 7. The overflow projections 5c are channel-shaped and are formed inside the chamber parallel to the axis of the syringe body. The length of the overhang projections 5c in the direction of the body axis is

  equal to 100% of the longitudinal extent of the piston 3.

  If the extreme piston 4 is pushed towards the exit of the syringe by means of a piston rod (not shown) fixed to the latter in a known usual manner, the intermediate piston 3 also moves towards the exit of the syringe since the syringe is filled with liquid between the intermediate piston 3 and the extreme piston 4. If, in the embodiment according to FIG. 1 which has only an overhanging projection in the form of a channel, substantially shorter than the piston 3 or in the form of a lug 5b, the piston 3 comes to bear on the overflow projection and if pressure continues to be exerted on the extreme piston 4, the piston 3 remains at the level of the overflow projection and s' inclined. The liquid then flows into the anterior chamber along the side of the syringe body which is opposite the overflow projection, by 1! the passage or bypass formed at this location. This process is interrupted when the extreme piston 4 comes into contact with the intermediate piston 3. When the pistons 3 and 4 continue to be pushed together, the contained liquid displaces all residual air from the anterior chamber

and is ready for injection.

  If the intermediate piston 3 is located over its entire length on the overhang projections 5c, which may be the case for example for the embodiment shown in FIG. 2, the piston 3 moves away from the wall of the body in the overflow protrusion region, so that when the end piston 4 continues to advance, the liquid flows into the anterior chamber through

  the resulting passages or bypasses 8 (Figure 3).

  The Luer adapter according to the invention which consists of three plastic parts will be described more precisely below with the aid of FIGS. 4A to 4D: First part: guide member with socket (FIG. 4A and B): The first part consists of a lower part in the form of a snap-on lid with a socket 9 for fixing on the extension of the syringe body or on a corresponding bottle neck, and in an upper part fixed to the previous one in an integral manner, which is under shape of a guide sleeve 10 for the Luer cone with the tip (second part) and which is mounted centrally on the lower part. The sleeve 9 consists of a slotted ring Figure 4B) to facilitate mounting on the extension. In addition, the first part has a locking ring 11i which is molded at the outer edge on the top of the lower part by means of a plurality of connecting ribs - a. After the first part has been mounted on the proiongement, the locking ring i1 is pushed onto the slotted ring 9 so that the latter is positioned firmly on the syringe body or the bottle neck. The lower part has on its upper surface a round central opening 16 to receive the tip 17 of the second part (FIG. 4C). The guide sleeve 10 is provided inside with a Luer blocking thread 12 which comprises two annular blocking projections 13 and 14 situated one above the other. The distance between the projections 13 and 14 is adapted to the length of the guide element 20 of the second part (Figure 4C) along the longitudinal axis, so that the guide element 20 can be fixed between the projections of blocking 13 and 14. Below the Luer blocking thread there is a blocking element

annular 15 wedge-shaped.

  Second part: Luer cone with tip (Figure 4C): The Luer cone with tip forms the mobile part of the Luer adapter. The upper end is designed as a Luer 18 cone to receive conventional cannulas and the like. The tip 17, injection molded on the guide element 20, is used to pierce the closure plug 24 (Figure 5) when the syringe is used. Inside the Luer cone and the tip there is a through cavity 19 through which

  the liquid can leave the syringe.

  Third part: closure cap (Figure 4D): The third part consists of an external closure cap in which a Luer closure cap 21 is integrated. The internal radius of the external closure cap-on is adapted to the dimensions of the guide sleeve 10 of the first part. On the inside of the lower edge of the external closure cap, sawtooth protrusions 22 are formed on any circumference 7a to ensure a solid and leak-tight support. The closure cap allows the sealed and sterile closure of the

  system until the time of use.

  Figure 5 shows the three parts as a fully assembled Luer adapter. In FIG. 5A, the Luer adapter is mounted on the extension 23 of the syringe body. FIG. 5B shows the Luer adapter with the locking ring 11 pushed on it. After the tip 17 has pierced the closure cap 24 and the closure cap (third part) has been removed, the syringe is

  ready to use, as shown in Figure 5C.

  The Luer adapter is pressed onto the extension 23 of the glass body, in place of a conventional rim cap. During this operation, the slotted ring 9 expands. Once the guide member with the sleeve (first part) is placed on the closure cap 24, the open ring 9 tightens on the extension 23. The Luer adapter is held on the extension 23 by means of the ring blocking 11, which is pressed and pushed on the slotted ring 9 until it rests on its upper edge. This prevents the slotted ring 9 from opening out. Under the action of a pressure exerted on the closure cap (third part), the Luer cone with the tip (second part) is moved downwards and the tip 17 is pushed through the closure cap 24. This opens passage 19 for the contents of the syringe. After the closure cap (third part) has been removed, a cannula, for example, can be installed and the syringe can then be used.

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Claims (10)

  1. Injection syringe consisting of a syringe body (2) with a glass wall, an extension (23) for blocking and supporting the flanges, formed on the end of the syringe body (2) and also allowing the mounting of a Luer adapter, and two pistons (3) and (4) made of elastic material, movable longitudinally and arranged inside the syringe body (2), the inside of the syringe body (2) being subdivided , substantially in the center of the syringe body (2), in an anterior chamber and a posterior chamber by the arrangement of the first piston (3), the second piston (4) which is provided at the end of the posterior chamber serving to generate the pressure necessary to evacuate the contents of the syringe to the outside, and the part of the wall of the syringe body (2) beginning at the end of the anterior chamber situated on the side of the piston comprising a bypass region, characterized in what the bypass region comprises, inside the anterior chamber, a point-shaped (5b) or channel-shaped (5a) overflow projection extending parallel to the axis of the syringe body (2), or else includes a plurality of canary-shaped overhang projections (5c) formed inside the anterior chamber e: extending parallel to the axis of the syringe body (2), and the Luer adapter which can be mounted on the end of the syringe body (2) consists of three separate parts which can be assembled, of which the first part consists of a guide member with a sleeve (9), the second part consists of a Luer cone (18) with a guide element (20) and a point (17) fixed below and has a through cavity (19) and the third part consists of an external closure cap in which a   Luer closure cap (21) is in: uneven.   2. Syringe according to claim 1, characterized in that the bypass region has a single projection in the form of a pin (5b) inside the anterior chamber.   3. Syringe according to claim 1, characterized in that the bypass region has a single overflow projection in the form of a channel (5a) formed inside the anterior chamber parallel to the axis of the syringe body (2) and whose maximum longitudinal dimension, in the direction of the axis of the body, coincides with the corresponding longitudinal dimension of the first piston (3) 4. Syringe according to claim 1, characterized in that the bypass region has a plurality of overhang projections in the form of a zanal (5c) formed inside the inner chamber, arranged regularly along the circumference of the syringe body ( 2) and extending parallel to the axis of the syringe body (2), the longitudinal dimension of the protruding projections in the direction of the axis of the body being equivalent to 0.8 to 1.2 times the longitudinal dimension   first piston (3.   5. Syringe according to claim 4, characterized in that the bypass region has two to six projections of overflow (5c).   6. Syringe according to claim 5, characterized in that the bypass region has two projections   symmetrically opposite overflow (5c).   7. Syringe according to any of the claims   previous, characterized in that the first part of the Luer adapter consists of the following components: a lower part in the form of a snap-on cover intended to fit on the extension (23) at the end of the syringe body ( 2) and to be mounted on this extension (23), with a round central opening (16) on the upper side so that the tip (17) of the second part passes through it during use, an upper part fixed so integral with the lower part, in the form of a guide sleeve (10) intended to receive the second part and mounted in a centered manner on the lower part, a sleeve (9) consisting of a ring with slits at the lower end of the part lower and a locking ring (11) which is molded at the outer edge on the top of the lower part by means of a plurality of connecting ribs (11a) and which serves for fixing, after the first part has been mounted on the extension (23) at the end of the syringe body (2), when the locking ring (11) is pushed on the bush (9).   8. Syringe according to claim 7, characterized in that the internal radius of the external closure cap of the third part is adapted to the dimensions of the guide sleeve (10) of the first part and in that sawtooth protuberances ( 22) are formed on the inside of the lower edge of the closure cap external, over its entire periphery.   9. Syringe according to claim 7, characterized in that the guide sleeve (10) has inside a Luer locking thread (12), a wedge-shaped annular locking element (15) being provided under the thread Luer locking device (12) and two annular locking projections (13) and (14) arranged one above the other being integrated in the Luer locking thread 17 2746653   10. Syringe according to claim 9, characterized in that the guide element (20) of the second part has a first annular channel and a second annular channel arranged one above the other and which can cooperate with the wedge-shaped locking element (15) of the first part.