WO2016059336A1 - Tip capping device and syringe comprising such a device - Google Patents
Tip capping device and syringe comprising such a device Download PDFInfo
- Publication number
- WO2016059336A1 WO2016059336A1 PCT/FR2015/052744 FR2015052744W WO2016059336A1 WO 2016059336 A1 WO2016059336 A1 WO 2016059336A1 FR 2015052744 W FR2015052744 W FR 2015052744W WO 2016059336 A1 WO2016059336 A1 WO 2016059336A1
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- WIPO (PCT)
- Prior art keywords
- inner cap
- outer shell
- tip
- ring
- radial
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M2005/3103—Leak prevention means for distal end of syringes, i.e. syringe end for mounting a needle
- A61M2005/3104—Caps for syringes without needle
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/001—Apparatus specially adapted for cleaning or sterilising syringes or needles
Definitions
- the present invention relates to a tip cap device and a syringe having such a device.
- Tip cap devices for syringes are well known. These devices seal the tip of the cylindrical body of the syringe.
- a syringe usually has a cylindrical body having an open proximal end and an opposite distal end.
- a cylindrical body defines a reservoir of fluid product to be dispensed.
- An elongated tip protrudes from the distal end of the syringe barrel and has a narrow passageway communicating with the reservoir.
- a plunger can be inserted into the open proximal end of the cylindrical barrel of the syringe to slide in fluid-tight contact with the wall of the barrel. A sliding movement of the piston in the distal direction expels the fluid product in the reservoir through the passageway in the nozzle.
- Standard syringe cylindrical bodies are made of plastic or glass.
- Such syringes may further include a needle assembly having a needle cannula having a proximal end, a pointed distal end and a passage extending axially therethrough.
- the needle assembly also includes a hub that is engageable with mounting means on the cylindrical body of the syringe for assembling the needle assembly to the hub.
- These mounting means generally comprise a ring, for example luer type, disposed around the tip of the cylindrical body of the syringe.
- This ring comprises a set of threads for a threaded socket with a corresponding structure existing on the hub of the needle.
- the ring may have an array of inner threads that can engage protrusions extending outwardly from the hub of the needle.
- a tip cap device is provided to seal said tip tightly.
- This assembly comprises, in addition to said ring, an inner cap which can cooperate sealingly with said tip, said inner cap being formed of a deformable sealing material, such as an elastomer, and a rigid outer shell fixed around said inner cap and engageable with said ring.
- This tip cap device is configured such that said inner cap comes into sealing contact with said tip when said outer shell is engaged with said ring, said inner cap freeing said tip in response to release of said outer shell from said ring.
- EP0716860, EP1 192965 and FR2786106 disclose tip cap devices of this type. These devices, however, have certain disadvantages.
- steam sterilization of the elastomeric inner cap may be difficult to achieve after assembly, due to the thickness of said part and the small available exchange surface, formed here by the only axial end surface of said inner cap. .
- the mechanical retention of the inner cap in the outer shell is difficult to guarantee, and is not easily predictable and reproducible.
- the rubber tends to stick on the glass and it generates significant efforts to remove the inner cap, with risks that it disengages from the outer shell if its attachment is not well controlled.
- the molding process is quite complex, in particular for the inner rubber cap, which requires in particular undercuts to make the peripheral fastening groove to the outer shell.
- EP1034810 discloses another prior art device, wherein the inner cap is inserted into the outer shell through the lower axial end thereof, the upper axial end being closed.
- This device also has drawbacks, especially with regard to the steam sterilization of the inner cap, because of the small exchange surface available, formed here by two windows. side of said outer shell.
- the fixing of the inner cap in the outer shell is not optimal, with a risk of disengagement of these two elements when the outer shell is released from the ring mounted on the syringe.
- Another object of the present invention is to provide a syringe tip cap device which provides a solid, predictable and reproducible assembly.
- Another object of the present invention is to provide a syringe tip cap device that is simple and inexpensive to manufacture and assemble.
- the present invention also aims to provide a method of assembling a syringe tip cap device that is simple and inexpensive to implement.
- an inner cap that can cooperate sealingly with said tip, said inner cap being formed of a deformable sealing material, such as an elastomer,
- said device being configured such that said inner cap comes into sealing contact with said tip when said outer shell is engaged with said ring, said inner cap freeing said tip in response to release of said outer shell from said ring;
- said outer shell forming a hollow sleeve having a lower axial opening cooperating with said ring and an upper axial opening, and in that said outer shell comprises at least one side window in its peripheral surface
- said inner cap having a head portion having a distal axial end edge and a radial shoulder axially offset from said distal axial end edge, said head portion being fixed in said outer shell being wedged between a radial bearing surface of said outer shell abutting said radial shoulder said inner cap and at least one radial projection of said outer shell cooperating with said distal axial end edge of said inner cap, said radial bearing surface of said outer shell being formed by a proximal axial edge of said at least one side window .
- said at least one radial projection of said outer shell is formed by a radial folding of the distal axial end edge of said outer shell on said distal axial end edge of said inner cap.
- said distal axial end edge of said inner cap is snapped under said at least one radial projection of said outer shell.
- said at least one radial projection of said outer shell is formed by an axial edge of said at least one side window.
- said inner cap is devoid of groove extending radially inwardly on its outer peripheral surface.
- the present invention also relates to a syringe comprising a cylindrical body forming a fluid reservoir and an endpiece projecting axially from said cylindrical body, comprising a tip cap device as described above,
- the present invention also relates to a method of manufacturing a tip cap device as described above, comprising the following steps:
- an inner cap of deformable sealing material such as an elastomer, said inner cap having no groove extending radially inwardly on its outer peripheral surface, said inner cap having a head portion having an edge distal axial end and a radial shoulder axially offset from said distal axial end edge,
- said fixing step is performed by folding an axial end edge distal of said outer shell on said distal axial end edge of said inner cap.
- said fixing step is performed by snapping said distal axial end edge of said inner cap under said at least one radial projection of said outer shell.
- said steps of inserting and fixing are carried out after said outer shell cooperates with said ring.
- FIG. 1 is a schematic perspective view of a syringe provided with a tip cap device according to an advantageous embodiment of the present invention
- FIG. 2 is a diagrammatic cross-sectional detail view of an inner cap according to an advantageous embodiment of the present invention
- Fig. 3 is a schematic cross-sectional detail view partially showing a prior art cap cap device
- Fig. 4 is a schematic cross-sectional view of the syringe cap device of Fig. 1; , and
- Figure 5 is a view similar to that of Figure 4, illustrating another advantageous embodiment of the present invention.
- the terms “upper” and “lower” refer to the upright position of the device as shown in the figures.
- the terms “axial” and “radial” (and their variations) refer to the central longitudinal axis A, shown in Figure 4.
- distal and proximal refer to the distance from the tip of the syringe.
- the tip cap device according to the invention is intended to be used with a syringe 10 having a cylindrical body 1 1 forming reservoir 12 of fluid and a tip 13 protruding axially from said cylindrical body January 1.
- a syringe 10 having a cylindrical body 1 1 forming reservoir 12 of fluid and a tip 13 protruding axially from said cylindrical body January 1.
- These elements can be of any shape and any appropriate fabrications.
- the end cap device comprises a rigid ring 20 which engages on said end-piece 13.
- a rigid outer shell 40 is provided to engage said ring 20.
- This outer shell 40 forms a hollow sleeve open at its two axial ends, and defines a lower axial opening and an upper axial opening 44.
- This outer shell 40 which is preferably molded, advantageously comprises axial external ribs 41 and an external thread 42 at its lower axial opening, adapted to cooperate with the internal thread 22 of the ring 20. Preferably, these threads form a luer-type fastener.
- the outer shell 40 has an axial projection 43 adapted to cooperate with a corresponding axial recess 23 of said ring 20 when said outer shell 40 is assembled on said ring 20, as can be seen in FIG. This generates a resistance to unscrewing that the user must overcome when he wishes to disengage the outer shell 40 of said ring 20. This resistance ensures good holding in the assembled position, limiting the risk of unintended unwanted or accidental unscrewing.
- An inner cap 30 is provided to cooperate sealingly with said tip 13.
- This inner cap 30 is formed, preferably by molding, of a deformable sealant, such as an elastomer. It advantageously comprises a head portion 35 comprising a distal axial end edge 37 and a radial shoulder 36 axially offset from said distal axial end edge 37.
- This head portion 35 is fixed in said outer shell 40 by being inserted at through said upper axial opening 44 and wedged between a radial bearing surface 46 of said outer shell 40 abuts against said radial shoulder 36 of said inner cap 30 and at least one radial projection 47, 48 of said outer shell 40 cooperating with said distal axial end edge 37 of said inner cap 30.
- the inner cap 30 further comprises an axial sealing projection 31, which comes into the outlet opening of said nozzle 13, and an axial sleeve 32 which fits around said nozzle 13 when the tip cap device is attached. to said syringe 10.
- Assembling the inner cap 30 through said upper axial aperture 44 of the outer shell is advantageous. On the one hand, it allows this assembly to be performed while the outer shell 40 is already fixed, in particular screwed, on the ring 20. As a result, the path of the elastomer during assembly is as short as possible. which limits the risks of contamination, particularly particulate matter. On the other hand, it allows better control of the positioning of the inner cap 30 on the tip 13 of the syringe during assembly. The support during assembly can thus be done directly on the inner cap 30, in particular from above through said upper axial opening 44 of the outer shell 40, and the control of the position of the inner cap 30 is thereby easier.
- the tip cap device is configured such that said inner cap 30 comes into sealing contact with said tip 13 when said outer shell 40 is engaged with said ring 20, said inner cap 30 being released from said tip 13 in response to the release of said outer shell 40 from said ring 20.
- the inner cap 30 is devoid of a groove extending radially inwardly on its outer peripheral surface. This implementation simplifies the manufacture of the inner cap and makes it more robust, in particular by increasing the thickness of the axial sleeve 32.
- This implementation of the prior art is disadvantageous because it imposes undercuts in the inner cap manufacturing mold, which makes its manufacture more complex and more expensive. In addition, the fixing force of this snap is not optimal, and difficult to predictable or reproducible.
- said at least one radial projection of said outer shell 40 is formed by a radial folding 47 of the distal axial end edge of said outer shell 40 on said distal axial end edge 37 of said inner cap 30. This folding can be performed hot by means of a suitable tool, after insertion of the inner cap 30 into said outer shell 40, with said radial shoulder 36 of said inner cap 30 abuts against said radial bearing surface 46 of said outer shell 40.
- said distal axial end edge 37 of said inner cap 30 is snapped under said at least one radial projection 48 of said outer shell 40.
- said outer shell 40 comprises, in addition to said upper axial opening 44, at least one side window 45 in its peripheral surface.
- at least two side windows 45 are provided.
- said at least one radial projection 48 of the embodiment of FIG. 5 may be formed by an axial edge distal from said at least one lateral window 45.
- said radial bearing surface 46 of said outer shell 40 is formed by a proximal axial edge of said at least one side window 45.
- the assembly of the inner cap 30 in the outer shell 40 by snapping of said head portion 35 into said windows 45 is simple and strong.
- the presence of one or more side window (s) 45 in the outer shell 40, combined with the presence of said upper axial opening 44, is particularly advantageous in that it greatly enhances the steam sterilization process, increasing the steam passage surfaces to the inner cap 30.
- the vapor contacts the inner cap 30 only at its distal axial end surface, and according to the thickness of said inner cap 30, and in particular of its head portion 35, steam sterilization may not be optimal.
- at least one side window 45 in the outer shell, and preferably a plurality of peripherally distributed windows the vapor can contact the inner cap on a larger overall area, and on different portions of the inner cap, promoting greater homogenous and optimal sterilization.
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Abstract
Description
Dispositif de capuchon d'embout et seringue comportant un tel dispositif Tip cap device and syringe having such a device
La présente invention concerne un dispositif de capuchon d'embout et une seringue comportant un tel dispositif. The present invention relates to a tip cap device and a syringe having such a device.
Les dispositifs de capuchon d'embout pour seringues sont bien connus. Ces dispositifs assurent l'étanchéité de l'embout du corps cylindrique de la seringue. Une seringue comporte habituellement un corps cylindrique ayant une extrémité proximale ouverte et une extrémité distale opposée. Un corps cylindrique définit un réservoir de produit fluide à distribuer. Un embout allongé fait saillie à partir de l'extrémité distale du corps cylindrique de la seringue et comporte un passage étroit qui communique avec le réservoir. Un piston peut être inséré dans l'extrémité proximale ouverte du corps cylindrique de la seringue pour coulisser en contact étanche au fluide avec la paroi du corps cylindrique. Un mouvement de coulissement du piston dans la direction distale expulse le produit fluide situé dans le réservoir à travers le passage existant dans l'embout. Inversement, un mouvement coulissant du piston dans la direction proximale attire du fluide vers l'intérieur du réservoir à travers le passage de l'embout. Des corps cylindriques de seringue habituels sont constitués de matière plastique ou de verre. De telles seringues peuvent en outre comporter un ensemble d'aiguille comportant une canule formant aiguille ayant une extrémité proximale, une extrémité distale pointue et un passage s'étendant axialement à travers celle-ci. L'ensemble d'aiguille comporte aussi un moyeu qui peut venir en prise avec des moyens de montage situés sur le corps cylindrique de la seringue pour assembler l'ensemble d'aiguille sur l'embout. Ces moyens de montage comportent généralement une bague, par exemple de type luer, disposée autour de l'embout du corps cylindrique de la seringue. Cette bague comporte un ensemble de filets destinés à une prise filetée avec une structure correspondante existant sur le moyeu de l'aiguille. Par exemple, la bague peut comporter un réseau de filets intérieurs qui peuvent venir en prise avec des saillies s'étendant vers l'extérieur à partir du moyeu de l'aiguille. En l'absence de l'ensemble d'aiguille, un dispositif de capuchon d'embout est prévu pour fermer ledit embout de manière étanche. Cet ensemble comporte, outre ladite bague, un capuchon intérieur pouvant coopérer de manière étanche avec ledit embout, ledit capuchon intérieur étant formé en un matériau d'étanchéité déformable, tel qu'un élastomère, et une coque externe rigide fixée autour dudit capuchon intérieur et pouvant venir en prise avec ladite bague. Ce dispositif de capuchon d'embout est configuré de telle sorte que ledit capuchon intérieur vient en contact étanche avec ledit embout lorsque ladite coque externe est en prise avec ladite bague, ledit capuchon intérieur se libérant dudit embout en réponse à la libération de ladite coque externe à partir de ladite bague. Tip cap devices for syringes are well known. These devices seal the tip of the cylindrical body of the syringe. A syringe usually has a cylindrical body having an open proximal end and an opposite distal end. A cylindrical body defines a reservoir of fluid product to be dispensed. An elongated tip protrudes from the distal end of the syringe barrel and has a narrow passageway communicating with the reservoir. A plunger can be inserted into the open proximal end of the cylindrical barrel of the syringe to slide in fluid-tight contact with the wall of the barrel. A sliding movement of the piston in the distal direction expels the fluid product in the reservoir through the passageway in the nozzle. Conversely, sliding movement of the piston in the proximal direction attracts fluid to the interior of the reservoir through the passageway of the tip. Standard syringe cylindrical bodies are made of plastic or glass. Such syringes may further include a needle assembly having a needle cannula having a proximal end, a pointed distal end and a passage extending axially therethrough. The needle assembly also includes a hub that is engageable with mounting means on the cylindrical body of the syringe for assembling the needle assembly to the hub. These mounting means generally comprise a ring, for example luer type, disposed around the tip of the cylindrical body of the syringe. This ring comprises a set of threads for a threaded socket with a corresponding structure existing on the hub of the needle. For example, the ring may have an array of inner threads that can engage protrusions extending outwardly from the hub of the needle. In the absence of the needle assembly, a tip cap device is provided to seal said tip tightly. This assembly comprises, in addition to said ring, an inner cap which can cooperate sealingly with said tip, said inner cap being formed of a deformable sealing material, such as an elastomer, and a rigid outer shell fixed around said inner cap and engageable with said ring. This tip cap device is configured such that said inner cap comes into sealing contact with said tip when said outer shell is engaged with said ring, said inner cap freeing said tip in response to release of said outer shell from said ring.
Les documents EP0716860, EP1 192965 et FR2786106 décrivent des dispositifs de capuchon d'embout de ce type. Ces dispositifs présentent toutefois certains inconvénients. Ainsi, la stérilisation vapeur du capuchon intérieur en élastomère peut être difficile à réaliser après assemblage, en raison de l'épaisseur de ladite pièce et de la faible surface d'échange disponible, formée ici par la seule surface d'extrémité axiale dudit capuchon intérieur. Par ailleurs, le maintien mécanique du capuchon intérieur dans la coque externe est difficile à garantir, et n'est pas aisément prédéterminable et reproductible. Or, par nature, le caoutchouc à tendance à coller sur le verre et cela engendre des efforts importants pour retirer la capuchon intérieur, avec des risques qu'il se désolidarise de la coque externe si sa fixation n'est pas bien maîtrisée. De plus, le procédé de moulage est assez complexe, en particulier pour le capuchon intérieur en caoutchouc, qui nécessite notamment des contre-dépouilles pour réaliser la gorge périphérique d'accrochage à la coque externe. EP0716860, EP1 192965 and FR2786106 disclose tip cap devices of this type. These devices, however, have certain disadvantages. Thus, steam sterilization of the elastomeric inner cap may be difficult to achieve after assembly, due to the thickness of said part and the small available exchange surface, formed here by the only axial end surface of said inner cap. . Moreover, the mechanical retention of the inner cap in the outer shell is difficult to guarantee, and is not easily predictable and reproducible. However, by nature, the rubber tends to stick on the glass and it generates significant efforts to remove the inner cap, with risks that it disengages from the outer shell if its attachment is not well controlled. In addition, the molding process is quite complex, in particular for the inner rubber cap, which requires in particular undercuts to make the peripheral fastening groove to the outer shell.
Le document EP1034810 décrit un autre dispositif de l'état de la technique, dans lequel le capuchon intérieur est inséré dans la coque externe à travers l'extrémité axiale inférieure de celle-ci, l'extrémité axiale supérieure étant fermée. Ce dispositif présente aussi des inconvénients, notamment concernant la stérilisation vapeur du capuchon intérieur, en raison de la faible surface d'échange disponible, formée ici par deux fenêtres latérales de ladite coque externe. De plus, la fixation du capuchon intérieur dans la coque externe n'est pas optimale, avec un risque de désolidarisation de ces deux éléments lorsque la coque externe est libérée de la bague montée sur la seringue. Par ailleurs, dans ce dispositif, il faut d'abord assembler le capuchon intérieur en élastomère dans la coque externe, puis il faut assembler cet ensemble sur la bague fixée à la seringue. L'élastomère subit donc deux étapes d'assemblage successives, favorisant le risque de contamination, notamment une contamination particulaire. EP1034810 discloses another prior art device, wherein the inner cap is inserted into the outer shell through the lower axial end thereof, the upper axial end being closed. This device also has drawbacks, especially with regard to the steam sterilization of the inner cap, because of the small exchange surface available, formed here by two windows. side of said outer shell. In addition, the fixing of the inner cap in the outer shell is not optimal, with a risk of disengagement of these two elements when the outer shell is released from the ring mounted on the syringe. Moreover, in this device, it is first necessary to assemble the inner elastomer cap in the outer shell, then it is necessary to assemble this assembly on the ring attached to the syringe. The elastomer undergoes two successive assembly steps, promoting the risk of contamination, including particulate contamination.
Les documents DE19547431 , WO2013047042, WO2014131985 et WO2014049097 décrivent d'autres dispositifs de l'état de la technique. The documents DE19547431, WO2013047042, WO2014131985 and WO2014049097 describe other devices of the state of the art.
La présente invention a pour but de fournir un dispositif de capuchon d'embout pour seringue qui ne reproduit pas les inconvénients susmentionnés. It is an object of the present invention to provide a syringe tip cap device which does not reproduce the aforementioned drawbacks.
En particulier, la présente invention a pour but de fournir dispositif de capuchon d'embout pour seringue qui améliore la stérilisation après assemblage. In particular, it is an object of the present invention to provide a syringe tip cap device which improves sterilization after assembly.
La présente invention a également pour but de fournir un dispositif de capuchon d'embout pour seringue qui assure un assemblage solide, prédéterminable et reproductible. Another object of the present invention is to provide a syringe tip cap device which provides a solid, predictable and reproducible assembly.
La présente invention a aussi pour but de fournir un dispositif de capuchon d'embout pour seringue qui soit simple et peu coûteux à fabriquer et à assembler. Another object of the present invention is to provide a syringe tip cap device that is simple and inexpensive to manufacture and assemble.
La présente invention a aussi pour but de fournir un procédé d'assemblage d'un dispositif de capuchon d'embout pour seringue qui soit simple et peu coûteux à mettre en œuvre. The present invention also aims to provide a method of assembling a syringe tip cap device that is simple and inexpensive to implement.
La présente invention a donc pour objet un dispositif de capuchon d'embout destiné à être utilisé avec une seringue ayant un corps cylindrique formant réservoir de produit fluide et un embout faisant saillie axialement dudit corps cylindrique, ledit dispositif de capuchon d'embout comportant: It is therefore an object of the present invention to provide a tip cap device for use with a syringe having a cylindrical fluid reservoir body and a tip projecting axially from said cylindrical body, said tip cap device comprising:
- une bague rigide en prise sur ledit embout, - un capuchon intérieur pouvant coopérer de manière étanche avec ledit embout, ledit capuchon intérieur étant formé en un matériau d'étanchéité déformable, tel qu'un élastomère, a rigid ring engaged on said endpiece, an inner cap that can cooperate sealingly with said tip, said inner cap being formed of a deformable sealing material, such as an elastomer,
- une coque externe rigide fixée autour dudit capuchon intérieur et pouvant venir en prise avec ladite bague, a rigid outer shell fixed around said inner cap and engageable with said ring,
ledit dispositif étant configuré de telle sorte que ledit capuchon intérieur vient en contact étanche avec ledit embout lorsque ladite coque externe est en prise avec ladite bague, ledit capuchon intérieur se libérant dudit embout en réponse à la libération de ladite coque externe à partir de ladite bague, said device being configured such that said inner cap comes into sealing contact with said tip when said outer shell is engaged with said ring, said inner cap freeing said tip in response to release of said outer shell from said ring; ,
ladite coque externe formant un manchon creux comportant une ouverture axiale inférieure coopérant avec ladite bague et une ouverture axiale supérieur, et en ce que ladite coque externe comporte au moins une fenêtre latérale dans sa surface périphérique, ledit capuchon intérieur comportant une partie de tête comportant un bord d'extrémité axiale distale et un épaulement radial décalé axialement dudit bord d'extrémité axiale distale, ladite partie de tête étant fixée dans ladite coque externe en étant coincée entre une surface d'appui radiale de ladite coque externe en butée contre ledit épaulement radial dudit capuchon intérieur et au moins une projection radiale de ladite coque externe coopérant avec ledit bord d'extrémité axiale distale dudit capuchon intérieur, ladite surface d'appui radiale de ladite coque externe étant formée par un bord axial proximal de ladite au moins une fenêtre latérale. said outer shell forming a hollow sleeve having a lower axial opening cooperating with said ring and an upper axial opening, and in that said outer shell comprises at least one side window in its peripheral surface, said inner cap having a head portion having a distal axial end edge and a radial shoulder axially offset from said distal axial end edge, said head portion being fixed in said outer shell being wedged between a radial bearing surface of said outer shell abutting said radial shoulder said inner cap and at least one radial projection of said outer shell cooperating with said distal axial end edge of said inner cap, said radial bearing surface of said outer shell being formed by a proximal axial edge of said at least one side window .
Avantageusement, ladite au moins une projection radiale de ladite coque externe est formée par un rabattement radial du bord d'extrémité axiale distale de ladite coque externe sur ledit bord d'extrémité axiale distale dudit capuchon intérieur. Advantageously, said at least one radial projection of said outer shell is formed by a radial folding of the distal axial end edge of said outer shell on said distal axial end edge of said inner cap.
Avantageusement, ledit bord d'extrémité axiale distale dudit capuchon intérieur est encliqueté sous ladite au moins une projection radiale de ladite coque externe. Avantageusement, ladite au moins une projection radiale de ladite coque externe est formée par un bord axial de ladite au moins une fenêtre latérale. Advantageously, said distal axial end edge of said inner cap is snapped under said at least one radial projection of said outer shell. Advantageously, said at least one radial projection of said outer shell is formed by an axial edge of said at least one side window.
Avantageusement, ledit capuchon intérieur est dépourvu de gorge s'étendant radialement vers l'intérieur sur sa surface périphérique externe. Advantageously, said inner cap is devoid of groove extending radially inwardly on its outer peripheral surface.
La présente invention a aussi pour objet une seringue comportant un corps cylindrique formant réservoir de produit fluide et un embout faisant saillie axialement dudit corps cylindrique, comportant un dispositif de capuchon d'embout tel que décrit ci-dessus, The present invention also relates to a syringe comprising a cylindrical body forming a fluid reservoir and an endpiece projecting axially from said cylindrical body, comprising a tip cap device as described above,
La présente invention a également pour objet un procédé de fabrication d'un dispositif de capuchon d'embout tel que décrit ci-dessus, comprenant les étapes suivantes: The present invention also relates to a method of manufacturing a tip cap device as described above, comprising the following steps:
- mouler une bague rigide adaptée à être en prise avec un embout d'une seringue, molding a rigid ring adapted to be engaged with a tip of a syringe,
- mouler une coque externe rigide adaptée à coopérer avec ladite bague, ladite coque externe comportant une surface d'appui radiale et au moins une fenêtre latérale dans sa surface périphérique, molding a rigid outer shell adapted to cooperate with said ring, said outer shell having a radial bearing surface and at least one side window in its peripheral surface;
- mouler un capuchon intérieur en matériau d'étanchéité déformable, tel qu'un élastomère, ledit capuchon intérieur étant dépourvu de gorge s'étendant radialement vers l'intérieur sur sa surface périphérique externe, ledit capuchon intérieur comportant une partie de tête comportant un bord d'extrémité axiale distale et un épaulement radial décalé axialement dudit bord d'extrémité axiale distale, molding an inner cap of deformable sealing material, such as an elastomer, said inner cap having no groove extending radially inwardly on its outer peripheral surface, said inner cap having a head portion having an edge distal axial end and a radial shoulder axially offset from said distal axial end edge,
- insérer ledit capuchon intérieur dans ladite coque externe à travers ladite ouverture axiale supérieure, avec ledit épaulement radial dudit capuchon intérieur en butée sur ladite surface d'appui radiale de ladite coque externe, et inserting said inner cap into said outer shell through said upper axial opening, with said radial shoulder of said inner cap abutting said radial bearing surface of said outer shell, and
- fixer ledit capuchon intérieur dans ladite coque externe au moyen d'au moins une projection radiale de ladite coque externe coopérant avec ledit bord d'extrémité axiale distale dudit capuchon intérieur. Avantageusement, ladite étape de fixer est réalisée en rabattant un bord d'extrémité axiale distale de ladite coque externe sur ledit bord d'extrémité axiale distale dudit capuchon intérieur. - Fixing said inner cap in said outer shell by means of at least one radial projection of said outer shell cooperating with said distal axial end edge of said inner cap. Advantageously, said fixing step is performed by folding an axial end edge distal of said outer shell on said distal axial end edge of said inner cap.
Avantageusement, ladite étape de fixer est réalisée en encliquetant ledit bord d'extrémité axiale distale dudit capuchon intérieur sous ladite au moins une projection radiale de ladite coque externe. Advantageously, said fixing step is performed by snapping said distal axial end edge of said inner cap under said at least one radial projection of said outer shell.
Avantageusement, lesdites étapes d'insérer et de fixer sont réalisées après que ladite coque externe coopère avec ladite bague. Advantageously, said steps of inserting and fixing are carried out after said outer shell cooperates with said ring.
Ces caractéristiques et avantages et d'autres de la présente invention apparaîtront plus clairement au cours de la description détaillée suivante, faite en référence aux dessins joints, donnés à titre d'exemples non-limitatifs, et sur lesquels : These and other features and advantages of the present invention will appear more clearly in the following detailed description, with reference to the accompanying drawings, given by way of non-limiting examples, and in which:
la figure 1 est une vue schématique en perspective d'une seringue pourvue d'un dispositif de capuchon d'embout selon un mode de réalisation avantageux de la présente invention, FIG. 1 is a schematic perspective view of a syringe provided with a tip cap device according to an advantageous embodiment of the present invention,
la figure 2 est une vue schématique de détail en section transversale d'un capuchon intérieur selon un mode de réalisation avantageux de la présente invention, FIG. 2 is a diagrammatic cross-sectional detail view of an inner cap according to an advantageous embodiment of the present invention,
la figure 3 est une vue schématique de détail en section transversale montrant partiellement un dispositif de capuchon d'embout de l'art antérieur, la figure 4 est une vue schématique en section transversale du dispositif de capuchon d'embout pour seringue de la figure 1 , et Fig. 3 is a schematic cross-sectional detail view partially showing a prior art cap cap device; Fig. 4 is a schematic cross-sectional view of the syringe cap device of Fig. 1; , and
la figure 5 est une vue similaire à celle de la figure 4, illustrant un autre mode de réalisation avantageux de la présente invention. Figure 5 is a view similar to that of Figure 4, illustrating another advantageous embodiment of the present invention.
Dans la description ci-après, les termes "supérieur" et "inférieur" se réfèrent à la position droite du dispositif telle que représentée sur les figures. Les termes "axial" et "radial" (et leurs déclinaisons) se réfèrent à l'axe central longitudinal A, représenté sur la figure 4. Les termes "distal" et "proximal" se réfèrent à l'éloignement par rapport à l'embout de la seringue. In the description below, the terms "upper" and "lower" refer to the upright position of the device as shown in the figures. The terms "axial" and "radial" (and their variations) refer to the central longitudinal axis A, shown in Figure 4. The terms "distal" and "proximal" refer to the distance from the tip of the syringe.
En référence aux figures 1 , 2 et 4, il est représenté un premier mode de réalisation de l'invention. Le dispositif de capuchon d'embout selon l'invention est destiné à être utilisé avec une seringue 10 ayant un corps cylindrique 1 1 formant réservoir 12 de produit fluide et un embout 13 faisant saillie axialement dudit corps cylindrique 1 1 . Ces éléments peuvent être de formes et de fabrications quelconques appropriées. With reference to FIGS. 1, 2 and 4, there is shown a first embodiment of the invention. The tip cap device according to the invention is intended to be used with a syringe 10 having a cylindrical body 1 1 forming reservoir 12 of fluid and a tip 13 protruding axially from said cylindrical body January 1. These elements can be of any shape and any appropriate fabrications.
Le dispositif de capuchon d'embout comporte une bague 20 rigide qui vient en prise sur ledit embout 13. Cette bague 20, qui est de préférence moulée, comporte avantageusement des nervures externes axiales 21 et un filetage interne 22. The end cap device comprises a rigid ring 20 which engages on said end-piece 13. This ring 20, which is preferably molded, advantageously comprises external axial ribs 21 and an internal thread 22.
Une coque externe 40 rigide est prévue pour venir en prise avec ladite bague 20. Cette coque externe 40 forme un manchon creux ouvert à ses deux extrémités axiales, et définit une ouverture axiale inférieure et une ouverture axiale supérieure 44. Cette coque externe 40, qui est de préférence moulée, comporte avantageusement des nervures externes axiales 41 et un filetage externe 42 au niveau de son ouverture axiale inférieure, adapté à coopérer avec le filetage interne 22 de la bague 20. De préférence, ces filetages forment une fixation du type luer. Avantageusement, la coque externe 40 comporte une projection axiale 43 adaptée à coopérer avec un évidement axial 23 correspondant de ladite bague 20 lorsque ladite coque externe 40 est assemblée sur ladite bague 20, comme visible sur la figure 1 . Ceci génère une résistance au dévissage que l'utilisateur doit surmonter lorsqu'il souhaite désolidariser la coque externe 40 de ladite bague 20. Cette résistance assure une bonne tenue en position assemblée, en limitant les risques de dévissage non souhaité ou accidentel. A rigid outer shell 40 is provided to engage said ring 20. This outer shell 40 forms a hollow sleeve open at its two axial ends, and defines a lower axial opening and an upper axial opening 44. This outer shell 40, which is preferably molded, advantageously comprises axial external ribs 41 and an external thread 42 at its lower axial opening, adapted to cooperate with the internal thread 22 of the ring 20. Preferably, these threads form a luer-type fastener. Advantageously, the outer shell 40 has an axial projection 43 adapted to cooperate with a corresponding axial recess 23 of said ring 20 when said outer shell 40 is assembled on said ring 20, as can be seen in FIG. This generates a resistance to unscrewing that the user must overcome when he wishes to disengage the outer shell 40 of said ring 20. This resistance ensures good holding in the assembled position, limiting the risk of unintended unwanted or accidental unscrewing.
Un capuchon intérieur 30 est prévu pour coopérer de manière étanche avec ledit embout 13. Ce capuchon intérieur 30 est formé, de préférence par moulage, en un matériau d'étanchéité déformable, tel qu'un élastomère. Il comporte avantageusement une partie de tête 35 comportant un bord d'extrémité axiale distale 37 et un épaulement radial 36 décalé axialement dudit bord d'extrémité axiale distale 37. Cette partie de tête 35 vient se fixer dans ladite coque externe 40 en étant insérée à travers ladite ouverture axiale supérieure 44 et coincée entre une surface d'appui radiale 46 de ladite coque externe 40 en butée contre ledit épaulement radial 36 dudit capuchon intérieur 30 et au moins une projection radiale 47, 48 de ladite coque externe 40 coopérant avec ledit bord d'extrémité axiale distale 37 dudit capuchon intérieur 30. Cette mise en œuvre garantit une parfaite fixation du capuchon intérieur 30 dans la coque externe 40, la résistance de cette fixation étant prédéterminable et reproductible. Le capuchon intérieur 30 comporte en outre une projection axiale d'étanchéité 31 , qui vient dans l'ouverture de sortie dudit embout 13, et un manchon axial 32 qui s'emmanche autour dudit embout 13 lorsque le dispositif de capuchon d'embout est fixé à ladite seringue 10. An inner cap 30 is provided to cooperate sealingly with said tip 13. This inner cap 30 is formed, preferably by molding, of a deformable sealant, such as an elastomer. It advantageously comprises a head portion 35 comprising a distal axial end edge 37 and a radial shoulder 36 axially offset from said distal axial end edge 37. This head portion 35 is fixed in said outer shell 40 by being inserted at through said upper axial opening 44 and wedged between a radial bearing surface 46 of said outer shell 40 abuts against said radial shoulder 36 of said inner cap 30 and at least one radial projection 47, 48 of said outer shell 40 cooperating with said distal axial end edge 37 of said inner cap 30. This implementation guarantees a perfect fixing the inner cap 30 in the outer shell 40, the resistance of this fixing being predictable and reproducible. The inner cap 30 further comprises an axial sealing projection 31, which comes into the outlet opening of said nozzle 13, and an axial sleeve 32 which fits around said nozzle 13 when the tip cap device is attached. to said syringe 10.
L'assemblage du capuchon intérieur 30 à travers ladite ouverture axiale supérieure 44 de la coque externe est avantageux. D'une part, il permet de réaliser cet assemblage alors que la coque externe 40 est déjà fixée, notamment vissée, sur la bague 20. De ce fait, le parcours de l'élastomère lors de l'assemblage est le plus court possible ce qui limite les risques de contamination, notamment particulaire. D'autre part, il permet de mieux maîtriser le positionnement du capuchon intérieur 30 sur l'embout 13 de la seringue lors de l'assemblage. L'appui lors de l'assemblage peut ainsi se faire directement sur le capuchon intérieur 30, notamment par le haut à travers ladite ouverture axiale supérieure 44 de la coque externe 40, et le contrôle de la position du capuchon intérieur 30 est de ce fait plus aisé. Assembling the inner cap 30 through said upper axial aperture 44 of the outer shell is advantageous. On the one hand, it allows this assembly to be performed while the outer shell 40 is already fixed, in particular screwed, on the ring 20. As a result, the path of the elastomer during assembly is as short as possible. which limits the risks of contamination, particularly particulate matter. On the other hand, it allows better control of the positioning of the inner cap 30 on the tip 13 of the syringe during assembly. The support during assembly can thus be done directly on the inner cap 30, in particular from above through said upper axial opening 44 of the outer shell 40, and the control of the position of the inner cap 30 is thereby easier.
Le dispositif de capuchon d'embout est configuré de telle sorte que ledit capuchon intérieur 30 vient en contact étanche avec ledit embout 13 lorsque ladite coque externe 40 est en prise avec ladite bague 20, ledit capuchon intérieur 30 se libérant dudit embout 13 en réponse à la libération de ladite coque externe 40 à partir de ladite bague 20. The tip cap device is configured such that said inner cap 30 comes into sealing contact with said tip 13 when said outer shell 40 is engaged with said ring 20, said inner cap 30 being released from said tip 13 in response to the release of said outer shell 40 from said ring 20.
Le capuchon intérieur 30 est dépourvu de gorge s'étendant radialement vers l'intérieur sur sa surface périphérique externe. Cette mise en œuvre simplifie la fabrication du capuchon intérieur et rend celui-ci plus robuste, en permettant notamment d'augmenter l'épaisseur du manchon axial 32. La figure 3, qui illustre l'art antérieur, montre un capuchon intérieur 30 comportant une telle gorge 39 dans laquelle vient s'encliqueter une projection radiale 49 de la coque externe 40. Cette mise en œuvre de l'art antérieur est désavantageuse, car elle impose des contre-dépouilles dans le moule de fabrication du capuchon intérieur, ce qui rend sa fabrication plus complexe et plus coûteuse. De plus, la force de fixation de cet encliquetage n'est pas optimale, et difficilement prédéterminable ou reproductible. The inner cap 30 is devoid of a groove extending radially inwardly on its outer peripheral surface. This implementation simplifies the manufacture of the inner cap and makes it more robust, in particular by increasing the thickness of the axial sleeve 32. FIG. 3, which illustrates the prior art, shows an inner cap 30 comprising such a groove 39 in which a radial projection 49 of the outer shell 40 snaps into engagement. This implementation of the prior art is disadvantageous because it imposes undercuts in the inner cap manufacturing mold, which makes its manufacture more complex and more expensive. In addition, the fixing force of this snap is not optimal, and difficult to predictable or reproducible.
Dans le mode de réalisation de la figure 4, ladite au moins une projection radiale de ladite coque externe 40 est formée par un rabattement radial 47 du bord d'extrémité axiale distale de ladite coque externe 40 sur ledit bord d'extrémité axiale distale 37 dudit capuchon intérieur 30. Ce rabattement peut être réalisé à chaud au moyen d'un outil approprié, après insertion du capuchon intérieur 30 dans ladite coque externe 40, avec ledit épaulement radial 36 dudit capuchon intérieur 30 en butée contre ladite surface d'appui radiale 46 de ladite coque externe 40. In the embodiment of FIG. 4, said at least one radial projection of said outer shell 40 is formed by a radial folding 47 of the distal axial end edge of said outer shell 40 on said distal axial end edge 37 of said inner cap 30. This folding can be performed hot by means of a suitable tool, after insertion of the inner cap 30 into said outer shell 40, with said radial shoulder 36 of said inner cap 30 abuts against said radial bearing surface 46 of said outer shell 40.
Dans le mode de réalisation de la figure 5, ledit bord d'extrémité axiale distale 37 dudit capuchon intérieur 30 est encliqueté sous ladite au moins une projection radiale 48 de ladite coque externe 40. In the embodiment of FIG. 5, said distal axial end edge 37 of said inner cap 30 is snapped under said at least one radial projection 48 of said outer shell 40.
Selon l'invention, ladite coque externe 40 comporte, outre ladite ouverture axiale supérieure 44, au moins une fenêtre latérale 45 dans sa surface périphérique. Avantageusement, au moins deux fenêtres latérales 45 sont prévues. According to the invention, said outer shell 40 comprises, in addition to said upper axial opening 44, at least one side window 45 in its peripheral surface. Advantageously, at least two side windows 45 are provided.
Avantageusement, ladite au moins une projection radiale 48 du mode de réalisation de la figure 5 peut être formée par un bord axial distal de ladite au moins une fenêtre latérale 45. Advantageously, said at least one radial projection 48 of the embodiment of FIG. 5 may be formed by an axial edge distal from said at least one lateral window 45.
Selon l'invention, ladite surface d'appui radiale 46 de ladite coque externe 40 est formée par un bord axial proximal de ladite au moins une fenêtre latérale 45. According to the invention, said radial bearing surface 46 of said outer shell 40 is formed by a proximal axial edge of said at least one side window 45.
L'assemblage du capuchon intérieur 30 dans la coque externe 40 par encliquetage de ladite partie de tête 35 dans lesdites fenêtres 45 est simple et résistant. La présence d'une ou plusieurs fenêtre(s) latérale(s) 45 dans la coque externe 40, combinée à la présence de ladite ouverture axiale supérieure 44, est particulièrement avantageuse en ce qu'elle améliore fortement le processus de stérilisation vapeur, en augmentant les surfaces de passage de la vapeur vers le capuchon intérieur 30. Dans le dispositif de l'art antérieur de la figure 3, la vapeur ne contacte le capuchon intérieur 30 qu'au niveau de sa surface d'extrémité axiale distale, et selon l'épaisseur dudit capuchon intérieur 30, et notamment de sa partie de tête 35, la stérilisation vapeur risque de ne pas être optimale. Au contraire, avec au moins une fenêtre latérale 45 dans la coque externe, et de préférence plusieurs fenêtres réparties sur la périphérie, la vapeur peut contacter le capuchon intérieur sur une plus grande surface globale, et sur des parties différentes du capuchon interne, favorisant une stérilisation homogène et optimale. The assembly of the inner cap 30 in the outer shell 40 by snapping of said head portion 35 into said windows 45 is simple and strong. The presence of one or more side window (s) 45 in the outer shell 40, combined with the presence of said upper axial opening 44, is particularly advantageous in that it greatly enhances the steam sterilization process, increasing the steam passage surfaces to the inner cap 30. In the prior art device of Fig. 3, the vapor contacts the inner cap 30 only at its distal axial end surface, and according to the thickness of said inner cap 30, and in particular of its head portion 35, steam sterilization may not be optimal. In contrast, with at least one side window 45 in the outer shell, and preferably a plurality of peripherally distributed windows, the vapor can contact the inner cap on a larger overall area, and on different portions of the inner cap, promoting greater homogenous and optimal sterilization.
La présente invention a été décrite en référence à deux modes de réalisation particuliers, mais il est entendu qu'elle n'est pas limitée par ceux- ci mais qu'au contraire l'homme du métier peut y apporter toutes modifications utiles sans sortir du cadre de la présente invention tel que défini par les revendications annexées. The present invention has been described with reference to two particular embodiments, but it is understood that it is not limited by them but that on the contrary the person skilled in the art can make any useful modifications without departing from the scope of the present invention as defined by the appended claims.
Claims
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| FR1459911 | 2014-10-16 | ||
| FR1459911A FR3027231B1 (en) | 2014-10-16 | 2014-10-16 | NOZZLE CAP DEVICE AND SYRINGE COMPRISING SUCH A DEVICE. |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| WO2016059336A1 true WO2016059336A1 (en) | 2016-04-21 |
Family
ID=52345303
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PCT/FR2015/052744 Ceased WO2016059336A1 (en) | 2014-10-16 | 2015-10-12 | Tip capping device and syringe comprising such a device |
Country Status (3)
| Country | Link |
|---|---|
| FR (1) | FR3027231B1 (en) |
| TW (1) | TW201615234A (en) |
| WO (1) | WO2016059336A1 (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2019147903A1 (en) * | 2018-01-26 | 2019-08-01 | Becton, Dickinson And Company | Flush syringe with shielded tip |
Citations (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP0716860A2 (en) | 1994-12-12 | 1996-06-19 | Becton, Dickinson and Company | Syringe tip cap |
| DE19547431A1 (en) | 1995-12-05 | 1997-06-12 | Schering Ag | Closure system for a sterile syringe |
| FR2786106A1 (en) | 1998-11-24 | 2000-05-26 | Becton Dickinson Co | SYRINGE AND TOE CAP ASSEMBLY |
| EP1034810A2 (en) | 1999-03-05 | 2000-09-13 | Arzneimittel GmbH Apotheker Vetter & Co. Ravensburg | Syringe for medical purposes and method for its assembly |
| WO2013047042A1 (en) | 2011-09-26 | 2013-04-04 | テルモ株式会社 | Syringe |
| WO2014049097A1 (en) | 2012-09-26 | 2014-04-03 | Transcoject Gmbh | Prefilled syringe |
| WO2014131985A1 (en) | 2013-03-01 | 2014-09-04 | Aptar Stelmi Sas | Injection device having a needle protection device |
-
2014
- 2014-10-16 FR FR1459911A patent/FR3027231B1/en active Active
-
2015
- 2015-10-12 WO PCT/FR2015/052744 patent/WO2016059336A1/en not_active Ceased
- 2015-10-16 TW TW104133967A patent/TW201615234A/en unknown
Patent Citations (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP0716860A2 (en) | 1994-12-12 | 1996-06-19 | Becton, Dickinson and Company | Syringe tip cap |
| EP1192965A1 (en) | 1994-12-12 | 2002-04-03 | Becton Dickinson and Company | Syringe tip cap |
| DE19547431A1 (en) | 1995-12-05 | 1997-06-12 | Schering Ag | Closure system for a sterile syringe |
| FR2786106A1 (en) | 1998-11-24 | 2000-05-26 | Becton Dickinson Co | SYRINGE AND TOE CAP ASSEMBLY |
| EP1034810A2 (en) | 1999-03-05 | 2000-09-13 | Arzneimittel GmbH Apotheker Vetter & Co. Ravensburg | Syringe for medical purposes and method for its assembly |
| WO2013047042A1 (en) | 2011-09-26 | 2013-04-04 | テルモ株式会社 | Syringe |
| WO2014049097A1 (en) | 2012-09-26 | 2014-04-03 | Transcoject Gmbh | Prefilled syringe |
| WO2014131985A1 (en) | 2013-03-01 | 2014-09-04 | Aptar Stelmi Sas | Injection device having a needle protection device |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2019147903A1 (en) * | 2018-01-26 | 2019-08-01 | Becton, Dickinson And Company | Flush syringe with shielded tip |
Also Published As
| Publication number | Publication date |
|---|---|
| FR3027231A1 (en) | 2016-04-22 |
| FR3027231B1 (en) | 2020-01-10 |
| TW201615234A (en) | 2016-05-01 |
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