WO2013104736A1 - Device for protecting the needle of a syringe - Google Patents

Device for protecting the needle of a syringe Download PDF

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Publication number
WO2013104736A1
WO2013104736A1 PCT/EP2013/050438 EP2013050438W WO2013104736A1 WO 2013104736 A1 WO2013104736 A1 WO 2013104736A1 EP 2013050438 W EP2013050438 W EP 2013050438W WO 2013104736 A1 WO2013104736 A1 WO 2013104736A1
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WO
WIPO (PCT)
Prior art keywords
needle
deformable element
protective device
radial
seal
Prior art date
Application number
PCT/EP2013/050438
Other languages
French (fr)
Inventor
Antoine Aneas
Original Assignee
Biocorp Recherche Et Developpement
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Biocorp Recherche Et Developpement filed Critical Biocorp Recherche Et Developpement
Publication of WO2013104736A1 publication Critical patent/WO2013104736A1/en

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Classifications

    • 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
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3202—Devices for protection of the needle before use, e.g. caps
    • 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
    • A61M2005/3117—Means preventing contamination of the medicament compartment of a syringe
    • A61M2005/3118—Means preventing contamination of the medicament compartment of a syringe via the distal end of a syringe, i.e. syringe end for mounting a needle cannula

Definitions

  • the present invention relates to a device for protecting the needle of a syringe, the protection device comprising:
  • a flexible sealing member adapted to prevent contamination of the needle and to be inserted into the rigid protective member, the flexible sealing member comprising a receiving chamber of the tip of the needle and a seal of sealing of the receiving chamber;
  • the protection device being adapted to evolve between:
  • An object of the invention is therefore to provide a needle protection device that simply and reliably prevents any contamination of the tip of the needle.
  • a protection device as defined above, characterized in that the biasing means are adapted to undergo a radial deformation during the passage of the prepared configuration to the mounted configuration and to transform this radial deformation into said radial stress.
  • the protection device according to the invention comprises one or more of the following characteristics:
  • said radial deformation is a radial compression
  • the biasing means comprise a deformable element associated with the flexible sealing member and a surface for holding and guiding the deformable element associated with the rigid protection member, the deformable element being able to undergo said deformation radial under the action of the holding and guiding surface;
  • the deformable element is an annular collar projecting from the flexible sealing member
  • the holding and guiding surface comprises a section for holding the deformable element, and in particular a groove, followed by a section, of frustoconical preference, of deformation of the deformable element, followed by a section, preferably cylindrical, of constriction of the deformable element;
  • the receiving chamber comprises an orifice for introducing the tip of the needle and an opening opposite the insertion orifice;
  • the rigid protection member comprises a sealing ring of said opening
  • the flexible sealing member further comprises a receiving cavity of the central zone of the needle, and there is provided a pressure relief valve adapted to limit the pressure inside said cavity;
  • the pressure relief valve comprises a sealing lip associated with the flexible sealing member and a complementary sealing ring associated with the rigid protection member;
  • said cavity comprises an evacuation orifice adapted to communicate, in mounted configuration, with the pressure relief valve.
  • Figure 1 is a longitudinal sectional view of a first embodiment of the protection device according to the invention, in the prepared configuration
  • Figure 2 is a longitudinal sectional view of the first embodiment of the protection device according to the invention, in mounted configuration
  • Figure 3 is a perspective view of the rigid protective member of the protective device of Figures 1 and 2;
  • Figure 4 is a perspective view of the flexible sealing member of the protective device of Figures 1 and 2;
  • FIG. 5 is a view similar to FIG. 2 of a second embodiment of the protection device according to the invention.
  • FIG. 6 is a view similar to FIG. 1 of a third embodiment of the protection device according to the invention.
  • FIGS 1 to 4 show a first embodiment of the protection device according to the invention.
  • This protection device 10 comprises a rigid member 12, preferably made of plastic, a flexible member 14, preferably an elastomer, and biasing means 13.
  • the rigid member 12 is shown in perspective in Figure 3. It comprises a cap 15, preferably of frustoconical shape, a plurality of ribs 16, and a terminal ring 18, preferably of cylindrical shape.
  • the cap 15, the ribs 16 and the end ring 18 are in one piece.
  • the cap 15 defines a longitudinal axis XX and has an outer surface 20 and an inner surface 22.
  • the cap 15 further has a head 24 and a base 26.
  • the base 26 is provided with a sealing ring 28, and the head 24 is provided with a sealing ring 30.
  • the inner surface 22 comprises a holding and guiding surface 32.
  • the holding and guiding surface 32 is divided into a section of retaining 34, in particular a groove, a section, preferably frustoconical, of deformation 36, and a section, preferably cylindrical, of constriction 38.
  • the ribs 16 protrude from the outer surface 20 of the cap 15 and extend longitudinally along the X-X axis.
  • Each rib 16 has a first curved end 40 located at the head 24 of the cap 15 and a second end 42 connected to the end ring 18.
  • the flexible member 14 is shown in perspective in Figure 4.
  • the flexible member 14 is divided into several sections, namely a syringe nose section 44, a section 46 for receiving the central zone of a needle, a sealing section 48, and a section 50 for receiving the tip of a needle.
  • the receiving section 44 is provided with a peripheral sealing lip 52.
  • a receiving recess 54 is formed in the receiving section 44.
  • the receiving recess 54 is adapted to the shape of a syringe nose.
  • the section 46 for receiving the central zone of a needle is preferably of substantially frustoconical shape.
  • a cavity 56 for receiving the central zone of a needle is made in the receiving section 46.
  • the cavity 56 is also preferably of substantially frustoconical shape.
  • the cavity 56 comprises a discharge orifice 58 which connects said cavity 56 with the environment around the flexible member 14. It will be noted that the receiving cavity 54 opens into the cavity 56.
  • the sealing section 48 is provided with a deformable element 60, in this case an annular collar projecting from the flexible member 14.
  • An introduction orifice 62 is located within the sealing section 48.
  • the insertion orifice 62 is bordered by a sealing gasket 64.
  • the sealing gasket 64 is in the form of an annular thickening delimiting one of the ends of the cavity 56. sealing 64 and the annular flange 60 are oriented in a plane P substantially perpendicular to the axis XX. It will be noted that the cavity 56 opens into the insertion orifice 62.
  • the section 50 for receiving the tip of a needle is preferably of substantially cylindrical or substantially frustoconical shape.
  • a receiving chamber 66 of the tip of a needle is formed within the receiving section 50.
  • the receiving chamber 66 is also preferably of substantially cylindrical shape or substantially frustoconical.
  • An opening 68 is located at the free end of the receiving section 50.
  • the receiving chamber 66 is delimited on one side by the opening 68 and on the other side by the insertion orifice 62.
  • the biasing means 13 of the protection device 10 comprise, on the side of the rigid member 12, the holding and guiding surface 32, and, on the side of the flexible member 14, the annular collar 60.
  • the operation of the protection device 10 will now be described with reference to FIGS. 1 and 2.
  • the protection device 10 is used to cover the needle 70 of a preferably prefilled syringe 72. Subsequently, denoted by the reference 74 the median area of the needle 70, by the reference 76 the tip of the needle 70, by the reference 78 the nose of the syringe 72, and by the reference 80 the active ingredient contained in the syringe 72.
  • the protection device 10 is first brought to the prepared configuration Cp shown in FIG. 1 by inserting the flexible member 14 inside the rigid member 12.
  • the flexible member 14 is held by the flange 60 engaged in the groove 34 of the rigid member 12.
  • the seal 64 is then free of stress.
  • the protection device 10 is mounted on the syringe nose 78 to arrive at the mounted configuration Cm shown in FIG. 2.
  • the nose 78 of the syringe is inserted into the hollow 54 so as to deform the receiving section 44 of the flexible member 14. A tight zone is thus obtained around the nose 78 of the syringe. This sealed zone helps to avoid contamination of the needle 70.
  • the tip 76 of the needle is then in the receiving chamber 66, and the median zone 74 of the needle is in the receiving cavity 56.
  • the rigid member 12 is pushed axially towards the syringe 72 until the flexible member 14 is locked inside the rigid member.
  • the mounting force is transmitted to the flexible member 14, forcing the flange 60 out of its groove 34.
  • the frustoconical deformation section 36 radially compresses the collar 60.
  • the flange 60 is compressed and surrounded by the cylindrical constriction section 38.
  • the flange 60 transforms the radial compression it undergoes into a radial sealing stress acting on the sealing gasket 64
  • the seal 64 is deformed and comes into pressure on the needle 70.
  • one end of the receiving chamber 66 is sealed in a simple and reliable manner.
  • the other end of the receiving chamber 66 corresponding to the opening 68 is sealed by penetration of the sealing ring 30 into the receiving section 50 of the flexible member 14.
  • the sealed receiving chamber 66 prevents contamination of the tip 76 of the needle and thus the active ingredient 80. In addition, the receiving chamber 66 creates a back pressure which prevents the active ingredient 80 from flowing out of the needle. 70.
  • the axial displacement of the rigid member 12 furthermore puts the sealing ring 28 in contact with the sealing lip 52.
  • the sealing lip 52 is thus deformed and put under stress.
  • the sealing ring 28 is substantially perpendicular to the sealing lip 52.
  • the sealing lip 52 and the sealing ring 28 together constitute a pressure relief valve 82.
  • This valve 82 comes into action, in particular during sterilization of the assembly constituted by the syringe 72 and by the protection device 10 mounted.
  • the pressure relief valve 82 which is in communication with the receiving cavity 56 through the discharge orifice 58, opens by deformation of the sealing lip 52 when a certain pressure threshold is exceeded inside. of the receiving cavity 56. Part of the air contained in the receiving cavity 56 can then escape. In this way, the pressure relief valve 82 prevents the pressure within the receiving cavity 56 from reaching a critical level which could lead to separation of the protection device 10 from the syringe nose 78.
  • FIG. 5 shows a second embodiment of the protection device 10 which differs from the first embodiment according to FIGS. 1 to 4 by the location of the pressure relief valve 82.
  • the pressure relief valve 82 is located at the receiving section 46 of the central zone of the needle.
  • the volume of air between the overpressure valve 82 and the receiving cavity 56 is reduced compared to the first embodiment.
  • Figure 6 shows a third embodiment of the protection device 10.
  • This is a simplified variant in that the pressure relief valve 82 and the associated discharge port 58 have been omitted.
  • This variant is acceptable insofar as, even without a pressure relief valve, the risk of separation of the protection device 10 from the syringe 72 during sterilization is low. Indeed, the mounting of the protective device 10 on the syringe 72 itself does not increase the pressure inside the receiving cavity 56 due to the escape of air through the needle to the outside, and the increase of the pressure inside the receiving cavity 56 during a possible subsequent sterilization is in generally insufficient to separate the protective device 10 from the syringe 72.

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  • Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

A device (10) for protecting the needle (70) of a syringe (72), said device (10) comprising a rigid member (12) for protecting the needle from external damage, a flexible sealing member (14) suitable for preventing contamination of the needle and for being inserted into the rigid member, said flexible sealing member (14) comprising a space (66) for receiving the tip (76) of the needle and a seal (64) for sealing the space, and stressing means for stressing the seal, said device being suitable for moving between a prepared configuration, wherein the seal is free of stress, and a raised configuration (Cm), wherein the stressing means exert radial sealing stress on the seal, whereof the stressing means are capable of withstanding radial deformation when moving from the prepared configuration to the raised configuration (Cm) and of transforming said radial deformation into said radial stress.

Description

Dispositif de protection de l'aiguille d'une seringue  Device for protecting the needle of a syringe
La présente invention concerne un dispositif de protection de l'aiguille d'une seringue, le dispositif de protection comprenant :  The present invention relates to a device for protecting the needle of a syringe, the protection device comprising:
un organe rigide de protection de l'aiguille d'agressions extérieures ;  a rigid organ for protecting the needle from external aggressions;
un organe souple d'étanchéité apte à empêcher la contamination de l'aiguille et à être inséré dans l'organe rigide de protection, l'organe souple d'étanchéité comportant une chambre de réception de la pointe de l'aiguille et un joint d'étanchement de la chambre de réception ; et  a flexible sealing member adapted to prevent contamination of the needle and to be inserted into the rigid protective member, the flexible sealing member comprising a receiving chamber of the tip of the needle and a seal of sealing of the receiving chamber; and
des moyens de sollicitation du joint d'étanchement,  means for biasing the sealing gasket,
le dispositif de protection étant adapté à évoluer entre :  the protection device being adapted to evolve between:
une configuration préparé, dans laquelle le joint d'étanchement est libre de contraintes ; et  a prepared configuration, in which the seal is free of constraints; and
une configuration monté, dans laquelle les moyens de sollicitation exercent une contrainte radiale d'étanchement sur le joint d'étanchement.  a mounted configuration, wherein the biasing means exerts a radial sealing stress on the seal.
Un tel dispositif de protection est connu notamment du document US 7,641 ,636. Il s'avère que, en fonction de sa manipulation, ce dispositif connu n'assure pas dans tous les cas la propreté de la pointe de l'aiguille.  Such a protection device is known in particular from US 7.641, 636. It turns out that, depending on its handling, this known device does not ensure in all cases the cleanliness of the tip of the needle.
Un but de l'invention est donc de proposer un dispositif de protection d'aiguille empêchant de manière simple et fiable toute contamination de la pointe de l'aiguille.  An object of the invention is therefore to provide a needle protection device that simply and reliably prevents any contamination of the tip of the needle.
Ce but est atteint par un dispositif de protection tel que défini ci-dessus, caractérisé en ce que les moyens de sollicitation sont adaptés à subir une déformation radiale lors du passage de la configuration préparé à la configuration monté et à transformer cette déformation radiale en ladite contrainte radiale. This object is achieved by a protection device as defined above, characterized in that the biasing means are adapted to undergo a radial deformation during the passage of the prepared configuration to the mounted configuration and to transform this radial deformation into said radial stress.
Selon des modes de réalisation préférés, le dispositif de protection selon l'invention comprend l'une ou plusieurs des caractéristiques suivantes :  According to preferred embodiments, the protection device according to the invention comprises one or more of the following characteristics:
- ladite déformation radiale est une compression radiale ;  said radial deformation is a radial compression;
- les moyens de sollicitation comportent un élément déformable associé à l'organe souple d'étanchéité et une surface de maintien et de guidage de l'élément déformable associée à l'organe rigide de protection, l'élément déformable étant apte à subir ladite déformation radiale sous l'action de la surface de maintien et de guidage ;  the biasing means comprise a deformable element associated with the flexible sealing member and a surface for holding and guiding the deformable element associated with the rigid protection member, the deformable element being able to undergo said deformation radial under the action of the holding and guiding surface;
- l'élément déformable est une collerette annulaire faisant saillie à partir de l'organe souple d'étanchéité ;  the deformable element is an annular collar projecting from the flexible sealing member;
- la surface de maintien et de guidage comprend une section de maintien de l'élément déformable, et notamment une rainure, suivie d'une section, de préférence tronconique, de déformation de l'élément déformable, suivie d'une section, de préférence cylindrique, de constriction de l'élément déformable ; the holding and guiding surface comprises a section for holding the deformable element, and in particular a groove, followed by a section, of frustoconical preference, of deformation of the deformable element, followed by a section, preferably cylindrical, of constriction of the deformable element;
- la chambre de réception comprend un orifice d'introduction de la pointe de l'aiguille et une ouverture à l'opposé de l'orifice d'introduction ;  the receiving chamber comprises an orifice for introducing the tip of the needle and an opening opposite the insertion orifice;
- l'organe rigide de protection comprend une bague d'étanchement de ladite ouverture ;  - The rigid protection member comprises a sealing ring of said opening;
- l'organe souple d'étanchéité comporte en outre une cavité de réception de la zone médiane de l'aiguille, et il y est prévu une valve de surpression adaptée à limiter la pression régnant à l'intérieur de ladite cavité ;  - The flexible sealing member further comprises a receiving cavity of the central zone of the needle, and there is provided a pressure relief valve adapted to limit the pressure inside said cavity;
- la valve de surpression comprend une lèvre d'étanchéité associée à l'organe souple d'étanchéité et un anneau d'étanchéité complémentaire associé à l'organe rigide de protection ;  the pressure relief valve comprises a sealing lip associated with the flexible sealing member and a complementary sealing ring associated with the rigid protection member;
- ladite cavité comprend un orifice d'évacuation adapté à communiquer, en configuration monté, avec la valve de surpression.  said cavity comprises an evacuation orifice adapted to communicate, in mounted configuration, with the pressure relief valve.
L'invention sera mieux comprise à la lecture de la description suivante détaillée de plusieurs modes de réalisation non limitatifs, en référence aux dessins, dans lesquels :  The invention will be better understood on reading the following detailed description of several non-limiting embodiments, with reference to the drawings, in which:
La figure 1 est une vue en coupe longitudinale d'un premier mode de réalisation du dispositif de protection selon l'invention, en configuration préparé ;  Figure 1 is a longitudinal sectional view of a first embodiment of the protection device according to the invention, in the prepared configuration;
La figure 2 est une vue en coupe longitudinale du premier mode de réalisation du dispositif de protection selon l'invention, en configuration monté ;  Figure 2 is a longitudinal sectional view of the first embodiment of the protection device according to the invention, in mounted configuration;
La figure 3 est une vue en perspective de l'organe rigide de protection du dispositif de protection des figures 1 et 2 ;  Figure 3 is a perspective view of the rigid protective member of the protective device of Figures 1 and 2;
La figure 4 est une vue en perspective de l'organe souple d'étanchéité du dispositif de protection des figures 1 et 2 ;  Figure 4 is a perspective view of the flexible sealing member of the protective device of Figures 1 and 2;
La figure 5 est une vue similaire à la figure 2 d'un deuxième mode de réalisation du dispositif de protection selon l'invention ; et  FIG. 5 is a view similar to FIG. 2 of a second embodiment of the protection device according to the invention; and
La figure 6 est une vue similaire à la figure 1 d'un troisième mode de réalisation du dispositif de protection selon l'invention.  FIG. 6 is a view similar to FIG. 1 of a third embodiment of the protection device according to the invention.
Les figures 1 à 4 représentent un premier mode de réalisation du dispositif de protection selon l'invention. Ce dispositif de protection 10 comprend un organe rigide 12, de préférence en plastique, un organe souple 14, de préférence en élastomère, et des moyens de sollicitation 13.  Figures 1 to 4 show a first embodiment of the protection device according to the invention. This protection device 10 comprises a rigid member 12, preferably made of plastic, a flexible member 14, preferably an elastomer, and biasing means 13.
L'organe rigide 12 est montré en perspective à la figure 3. Il comporte un capuchon 15, de préférence de forme tronconique, une pluralité de nervures 16, et une couronne terminale 18, de préférence de forme cylindrique. De préférence, le capuchon 15, les nervures 16 et la couronne terminale 18 sont d'un seul tenant. Le capuchon 15 définit un axe longitudinal X-X et dispose d'une surface externe 20 ainsi que d'une surface interne 22. Le capuchon 15 dispose en outre d'une tête 24 et d'une base 26. La base 26 est munie d'un anneau d'étanchéité 28, et la tête 24 est munie d'une bague d'étanchement 30. La surface interne 22 comprend une surface de maintien et de guidage 32. La surface de maintien et de guidage 32 est divisée en une section de maintien 34, notamment une rainure, une section, de préférence tronconique, de déformation 36, et une section, de préférence cylindrique, de constriction 38. The rigid member 12 is shown in perspective in Figure 3. It comprises a cap 15, preferably of frustoconical shape, a plurality of ribs 16, and a terminal ring 18, preferably of cylindrical shape. Preferably, the cap 15, the ribs 16 and the end ring 18 are in one piece. The cap 15 defines a longitudinal axis XX and has an outer surface 20 and an inner surface 22. The cap 15 further has a head 24 and a base 26. The base 26 is provided with a sealing ring 28, and the head 24 is provided with a sealing ring 30. The inner surface 22 comprises a holding and guiding surface 32. The holding and guiding surface 32 is divided into a section of retaining 34, in particular a groove, a section, preferably frustoconical, of deformation 36, and a section, preferably cylindrical, of constriction 38.
Les nervures 16 font saillie à partir de la surface externe 20 du capuchon 15 et s'étendent longitudinalement selon l'axe X-X. Chaque nervure 16 a une première extrémité bombée 40 se situant au niveau de la tête 24 du capuchon 15 et une deuxième extrémité 42 reliée à la couronne terminale 18.  The ribs 16 protrude from the outer surface 20 of the cap 15 and extend longitudinally along the X-X axis. Each rib 16 has a first curved end 40 located at the head 24 of the cap 15 and a second end 42 connected to the end ring 18.
L'organe souple 14 est montré en perspective à la figure 4. L'organe souple 14 est divisé en plusieurs tronçons, à savoir un tronçon 44 d'accueil de nez de seringue, un tronçon 46 de réception de la zone médiane d'une aiguille, un tronçon d'étanchement 48, et un tronçon 50 de réception de la pointe d'une aiguille.  The flexible member 14 is shown in perspective in Figure 4. The flexible member 14 is divided into several sections, namely a syringe nose section 44, a section 46 for receiving the central zone of a needle, a sealing section 48, and a section 50 for receiving the tip of a needle.
Le tronçon d'accueil 44 est pourvu d'une lèvre d'étanchéité 52 périphérique. Un creux d'accueil 54 est ménagé au sein du tronçon d'accueil 44. Le creux d'accueil 54 est adapté à la forme d'un nez de seringue.  The receiving section 44 is provided with a peripheral sealing lip 52. A receiving recess 54 is formed in the receiving section 44. The receiving recess 54 is adapted to the shape of a syringe nose.
Le tronçon 46 de réception de la zone médiane d'une aiguille est de préférence de forme sensiblement tronconique. Une cavité 56 de réception de la zone médiane d'une aiguille est pratiquée au sein du tronçon de réception 46. La cavité 56 est également de préférence de forme sensiblement tronconique. En outre, la cavité 56 comprend un orifice d'évacuation 58 qui relie ladite cavité 56 avec l'environnement autour de l'organe souple 14. On notera que le creux d'accueil 54 débouche dans la cavité 56.  The section 46 for receiving the central zone of a needle is preferably of substantially frustoconical shape. A cavity 56 for receiving the central zone of a needle is made in the receiving section 46. The cavity 56 is also preferably of substantially frustoconical shape. In addition, the cavity 56 comprises a discharge orifice 58 which connects said cavity 56 with the environment around the flexible member 14. It will be noted that the receiving cavity 54 opens into the cavity 56.
Le tronçon d'étanchement 48 est muni d'un élément déformable 60, en l'occurrence d'une collerette annulaire faisant saillie à partir de l'organe souple 14. Un orifice d'introduction 62 se situe au sein du tronçon d'étanchement 48. L'orifice d'introduction 62 est bordé d'un joint d'étanchement 64. Le joint d'étanchement 64 est réalisé sous la forme d'un épaississement annulaire délimitant l'une des extrémités de la cavité 56. Le joint d'étanchement 64 et la collerette annulaire 60 sont orientés selon un plan P sensiblement perpendiculaire à l'axe X-X. On notera que la cavité 56 débouche dans l'orifice d'introduction 62.  The sealing section 48 is provided with a deformable element 60, in this case an annular collar projecting from the flexible member 14. An introduction orifice 62 is located within the sealing section 48. The insertion orifice 62 is bordered by a sealing gasket 64. The sealing gasket 64 is in the form of an annular thickening delimiting one of the ends of the cavity 56. sealing 64 and the annular flange 60 are oriented in a plane P substantially perpendicular to the axis XX. It will be noted that the cavity 56 opens into the insertion orifice 62.
Le tronçon 50 de réception de la pointe d'une aiguille est de préférence de forme sensiblement cylindrique ou sensiblement tronconique. Une chambre de réception 66 de la pointe d'une aiguille est réalisée au sein du tronçon de réception 50. La chambre de réception 66 est également de préférence de forme sensiblement cylindrique ou sensiblement tronconique. Une ouverture 68 se situe à l'extrémité libre du tronçon de réception 50. La chambre de réception 66 est délimitée d'un côté par l'ouverture 68 et de l'autre côté par l'orifice d'introduction 62. The section 50 for receiving the tip of a needle is preferably of substantially cylindrical or substantially frustoconical shape. A receiving chamber 66 of the tip of a needle is formed within the receiving section 50. The receiving chamber 66 is also preferably of substantially cylindrical shape or substantially frustoconical. An opening 68 is located at the free end of the receiving section 50. The receiving chamber 66 is delimited on one side by the opening 68 and on the other side by the insertion orifice 62.
Les moyens de sollicitation 13 du dispositif de protection 10 comprennent, du côté de l'organe rigide 12, la surface de maintien et de guidage 32, et, du côté de l'organe souple 14, la collerette annulaire 60.  The biasing means 13 of the protection device 10 comprise, on the side of the rigid member 12, the holding and guiding surface 32, and, on the side of the flexible member 14, the annular collar 60.
On va maintenant décrire le fonctionnement du dispositif de protection 10 en référence aux figures 1 et 2. Le dispositif de protection 10 est utilisé pour couvrir l'aiguille 70 d'une seringue 72 de préférence pré-remplie. Par la suite, on dénote par la référence 74 la zone médiane de l'aiguille 70, par la référence 76 la pointe de l'aiguille 70, par la référence 78 le nez de la seringue 72, et par la référence 80 le principe actif contenu dans la seringue 72.  The operation of the protection device 10 will now be described with reference to FIGS. 1 and 2. The protection device 10 is used to cover the needle 70 of a preferably prefilled syringe 72. Subsequently, denoted by the reference 74 the median area of the needle 70, by the reference 76 the tip of the needle 70, by the reference 78 the nose of the syringe 72, and by the reference 80 the active ingredient contained in the syringe 72.
Afin de couvrir l'aiguille 70, le dispositif de protection 10 est d'abord amené vers la configuration préparé Cp montrée à la figure 1 en insérant l'organe souple 14 à l'intérieur de l'organe rigide 12. Dans cette configuration préparé Cp, l'organe souple 14 est maintenu par la collerette 60 engagée dans la rainure 34 de l'organe rigide 12. Le joint d'étanchement 64 est alors libre de contraintes.  In order to cover the needle 70, the protection device 10 is first brought to the prepared configuration Cp shown in FIG. 1 by inserting the flexible member 14 inside the rigid member 12. In this prepared configuration Cp, the flexible member 14 is held by the flange 60 engaged in the groove 34 of the rigid member 12. The seal 64 is then free of stress.
Ensuite, le dispositif de protection 10 est monté sur le nez 78 de seringue pour arriver à la configuration monté Cm montrée à la figure 2.  Then, the protection device 10 is mounted on the syringe nose 78 to arrive at the mounted configuration Cm shown in FIG. 2.
Plus précisément, le nez 78 de seringue est inséré dans le creux 54 de manière à déformer le tronçon d'accueil 44 de l'organe souple 14. On obtient ainsi une zone étanche autour du nez 78 de seringue. Cette zone étanche participe à éviter une contamination de l'aiguille 70. La pointe 76 de l'aiguille se situe alors dans la chambre de réception 66, et la zone médiane 74 de l'aiguille se situe dans la cavité de réception 56.  More specifically, the nose 78 of the syringe is inserted into the hollow 54 so as to deform the receiving section 44 of the flexible member 14. A tight zone is thus obtained around the nose 78 of the syringe. This sealed zone helps to avoid contamination of the needle 70. The tip 76 of the needle is then in the receiving chamber 66, and the median zone 74 of the needle is in the receiving cavity 56.
Puis, l'organe rigide 12 est poussé axialement vers la seringue 72 jusqu'à ce que l'organe souple 14 soit verrouillé à l'intérieur de l'organe rigide.  Then, the rigid member 12 is pushed axially towards the syringe 72 until the flexible member 14 is locked inside the rigid member.
L'effort de montage est transmis à l'organe souple 14, obligeant la collerette 60 à sortir de sa rainure 34. En passant par-dessus, la section tronconique de déformation 36 comprime radialement la collerette 60. A la fin du déplacement axial de l'organe rigide 12, la collerette 60 se trouve comprimée et entourée par la section cylindrique de constriction 38. La collerette 60 transforme la compression radiale qu'elle subit en une contrainte radiale d'étanchement s'exerçant sur le joint d'étanchement 64. Ainsi, le joint d'étanchement 64 est déformé et vient en pression sur l'aiguille 70. De cette façon, une extrémité de la chambre de réception 66 est étanchée de manière simple et fiable. L'autre extrémité de la chambre de réception 66 correspondant à l'ouverture 68 est étanchée par pénétration de la bague d'étanchement 30 dans le tronçon de réception 50 de l'organe souple 14. The mounting force is transmitted to the flexible member 14, forcing the flange 60 out of its groove 34. When passing over, the frustoconical deformation section 36 radially compresses the collar 60. At the end of the axial displacement of the rigid member 12, the flange 60 is compressed and surrounded by the cylindrical constriction section 38. The flange 60 transforms the radial compression it undergoes into a radial sealing stress acting on the sealing gasket 64 Thus, the seal 64 is deformed and comes into pressure on the needle 70. In this way, one end of the receiving chamber 66 is sealed in a simple and reliable manner. The other end of the receiving chamber 66 corresponding to the opening 68 is sealed by penetration of the sealing ring 30 into the receiving section 50 of the flexible member 14.
La chambre de réception 66 étanche évite toute contamination de la pointe 76 de l'aiguille et ainsi du principe actif 80. En outre, la chambre de réception 66 crée une contre-pression qui empêche le principe actif 80 de couler hors de l'aiguille 70.  The sealed receiving chamber 66 prevents contamination of the tip 76 of the needle and thus the active ingredient 80. In addition, the receiving chamber 66 creates a back pressure which prevents the active ingredient 80 from flowing out of the needle. 70.
On notera qu'en configuration monté Cm l'organe rigide 12 protège l'aiguille contre toute agression extérieure.  Note that in mounted configuration Cm the rigid member 12 protects the needle against any external aggression.
Le déplacement axial de l'organe rigide 12 met en outre l'anneau d'étanchéité 28 en contact avec la lèvre d'étanchéité 52. La lèvre d'étanchéité 52 est ainsi déformée et mise sous contrainte. Dans cette configuration, l'anneau d'étanchéité 28 est sensiblement perpendiculaire à la lèvre d'étanchéité 52. On obtient ainsi une zone d'étanchéité évitant une contamination de l'aiguille 70.  The axial displacement of the rigid member 12 furthermore puts the sealing ring 28 in contact with the sealing lip 52. The sealing lip 52 is thus deformed and put under stress. In this configuration, the sealing ring 28 is substantially perpendicular to the sealing lip 52. Thus, a sealing zone is obtained which avoids contamination of the needle 70.
En configuration monté Cm, la lèvre d'étanchéité 52 et l'anneau d'étanchéité 28 constituent ensemble une valve de surpression 82. Cette valve 82 entre en action notamment lors d'une stérilisation de l'ensemble constitué par la seringue 72 et par le dispositif de protection 10 monté. Lors de la stérilisation, la pression à l'intérieur de la cavité de réception 56 augmente. La valve de surpression 82, qui est en communication avec la cavité de réception 56 à travers l'orifice d'évacuation 58, s'ouvre par déformation de la lèvre d'étanchéité 52 quand un certain seuil de pression est dépassé à l'intérieur de la cavité de réception 56. Une partie de l'air contenu dans la cavité de réception 56 peut alors s'échapper. De cette façon, la valve de surpression 82 empêche la pression à l'intérieur de la cavité de réception 56 d'atteindre un niveau critique qui risquerait de mener à une séparation du dispositif de protection 10 du nez 78 de seringue.  In the mounted configuration Cm, the sealing lip 52 and the sealing ring 28 together constitute a pressure relief valve 82. This valve 82 comes into action, in particular during sterilization of the assembly constituted by the syringe 72 and by the protection device 10 mounted. During sterilization, the pressure inside the receiving cavity 56 increases. The pressure relief valve 82, which is in communication with the receiving cavity 56 through the discharge orifice 58, opens by deformation of the sealing lip 52 when a certain pressure threshold is exceeded inside. of the receiving cavity 56. Part of the air contained in the receiving cavity 56 can then escape. In this way, the pressure relief valve 82 prevents the pressure within the receiving cavity 56 from reaching a critical level which could lead to separation of the protection device 10 from the syringe nose 78.
La figure 5 montre un deuxième mode de réalisation du dispositif de protection 10 qui se distingue du premier mode de réalisation selon les figures 1 à 4 de par l'emplacement de la valve de surpression 82. Dans cette variante, la valve de surpression 82 se situe au niveau du tronçon 46 de réception de la zone médiane de l'aiguille. Ainsi, le volume d'air situé entre la valve de surpression 82 et la cavité de réception 56 est réduit comparé au premier mode de réalisation.  FIG. 5 shows a second embodiment of the protection device 10 which differs from the first embodiment according to FIGS. 1 to 4 by the location of the pressure relief valve 82. In this variant, the pressure relief valve 82 is located at the receiving section 46 of the central zone of the needle. Thus, the volume of air between the overpressure valve 82 and the receiving cavity 56 is reduced compared to the first embodiment.
La figure 6 montre un troisième mode de réalisation du dispositif de protection 10. Il s'agit d'une variante simplifiée en ce que la valve de surpression 82 et l'orifice d'évacuation 58 associé ont été omis. Cette variante est acceptable dans la mesure où, même sans valve de surpression, le risque de séparation du dispositif de protection 10 de la seringue 72 lors d'une stérilisation est peu élevé. En effet, le montage du dispositif de protection 10 sur la seringue 72 en lui-même n'augmente pas la pression à l'intérieur de la cavité de réception 56 en raison de l'échappement de l'air à travers l'aiguille vers l'extérieur, et l'accroissement de la pression à l'intérieur de la cavité de réception 56 lors d'une éventuelle stérilisation ultérieure est en général insuffisant pour séparer le dispositif de protection 10 de la seringue 72. Figure 6 shows a third embodiment of the protection device 10. This is a simplified variant in that the pressure relief valve 82 and the associated discharge port 58 have been omitted. This variant is acceptable insofar as, even without a pressure relief valve, the risk of separation of the protection device 10 from the syringe 72 during sterilization is low. Indeed, the mounting of the protective device 10 on the syringe 72 itself does not increase the pressure inside the receiving cavity 56 due to the escape of air through the needle to the outside, and the increase of the pressure inside the receiving cavity 56 during a possible subsequent sterilization is in generally insufficient to separate the protective device 10 from the syringe 72.

Claims

REVENDICATIONS
Dispositif de protection (10) de l'aiguille (70) d'une seringue (72), le dispositif de protection (10) comprenant : Device (10) for protecting the needle (70) of a syringe (72), the protection device (10) comprising:
un organe rigide de protection (12) de l'aiguille d'agressions extérieures ; un organe souple d'étanchéité (14) apte à empêcher la contamination de l'aiguille et à être inséré dans l'organe rigide de protection, l'organe souple d'étanchéité (14) comportant une chambre de réception (66) de la pointe (76) de l'aiguille et un joint d'étanchement (64) de la chambre de réception ; et a rigid protection member (12) of the external attack needle; a flexible sealing member (14) adapted to prevent contamination of the needle and to be inserted into the rigid protective member, the flexible sealing member (14) comprising a receiving chamber (66) of the tip (76) of the needle and a seal (64) of the receiving chamber; and
des moyens de sollicitation (13) du joint d'étanchement, means for biasing (13) the seal,
le dispositif de protection étant adapté à évoluer entre : the protection device being adapted to evolve between:
une configuration préparé (Cp), dans laquelle le joint d'étanchement est libre de contraintes ; et a prepared configuration (Cp), in which the seal is free of constraints; and
une configuration monté (Cm), dans laquelle les moyens de sollicitation exercent une contrainte radiale d'étanchement sur le joint d'étanchement, caractérisé en ce que les moyens de sollicitation sont adaptés à subir une déformation radiale lors du passage de la configuration préparé (Cp) à la configuration monté (Cm) et à transformer cette déformation radiale en ladite contrainte radiale. a mounted configuration (Cm), in which the biasing means exert a radial sealing stress on the seal, characterized in that the biasing means are adapted to undergo radial deformation during the passage of the prepared configuration ( Cp) to the mounted configuration (Cm) and transforming this radial deformation into said radial stress.
Dispositif de protection selon la revendication 1 , dans lequel ladite déformation radiale est une compression radiale.  Protective device according to claim 1, wherein said radial deformation is a radial compression.
Dispositif de protection selon l'une quelconque des revendications précédentes, dans lequel les moyens de sollicitation comportent :  Protective device according to any one of the preceding claims, wherein the biasing means comprise:
un élément déformable (60) associé à l'organe souple d'étanchéité ; et une surface de maintien et de guidage (32) de l'élément déformable associée à l'organe rigide de protection, a deformable element (60) associated with the flexible sealing member; and a holding and guiding surface (32) of the deformable element associated with the rigid protection member,
l'élément déformable étant apte à subir ladite déformation radiale sous l'action de la surface de maintien et de guidage. the deformable element being able to undergo said radial deformation under the action of the holding and guiding surface.
Dispositif de protection selon la revendication 3, dans lequel l'élément déformable est une collerette annulaire (60) faisant saillie à partir de l'organe souple d'étanchéité.  Protective device according to claim 3, wherein the deformable element is an annular flange (60) projecting from the flexible sealing member.
Dispositif de protection selon la revendication 3 ou 4, dans lequel la surface de maintien et de guidage comprend :  Protective device according to claim 3 or 4, wherein the holding and guiding surface comprises:
une section de maintien (34) de l'élément déformable, et notamment une rainure, suivie d'une section, de préférence tronconique, de déformation (36) de l'élément déformable, suivie a holding section (34) of the deformable element, and in particular a groove, followed by a section, preferably frustoconical, deformation (36) of the deformable element, followed
d'une section, de préférence cylindrique, de constriction (38) de l'élément déformable. a section, preferably cylindrical, constriction (38) of the deformable element.
Dispositif de protection selon l'une quelconque des revendications précédentes, dans lequel la chambre de réception (66) comprend un orifice d'introduction (62) de la pointe de l'aiguille et une ouverture (68) à l'opposé de l'orifice d'introduction.  A protective device according to any one of the preceding claims, wherein the receiving chamber (66) comprises an insertion port (62) of the needle tip and an opening (68) opposite the introduction port.
Dispositif de protection selon la revendication 6, dans lequel l'organe rigide de protection comprend une bague d'étanchement (30) de ladite ouverture. Dispositif de protection selon l'une quelconque des revendications précédentes, dans lequel l'organe souple d'étanchéité comporte en outre une cavité (56) de réception de la zone médiane (74) de l'aiguille, et dans lequel il est prévu une valve de surpression (82) adaptée à limiter la pression régnant à l'intérieur de ladite cavité.  Protective device according to claim 6, wherein the rigid protective member comprises a sealing ring (30) of said opening. Protective device according to any one of the preceding claims, wherein the flexible sealing member further comprises a cavity (56) for receiving the central zone (74) of the needle, and in which there is provided a pressure relief valve (82) adapted to limit the pressure prevailing inside said cavity.
Dispositif de protection selon la revendication 8, dans lequel la valve de surpression (82) comprend une lèvre d'étanchéité (52) associée à l'organe souple d'étanchéité et un anneau d'étanchéité (28) complémentaire associé à l'organe rigide de protection.  Protective device according to claim 8, wherein the pressure relief valve (82) comprises a sealing lip (52) associated with the flexible sealing member and a complementary sealing ring (28) associated with the member rigid protection.
Dispositif selon la revendication 8 ou 9, dans lequel ladite cavité comprend un orifice d'évacuation (58) adapté à communiquer, en configuration monté, avec la valve de surpression.  Device according to claim 8 or 9, wherein said cavity comprises a discharge port (58) adapted to communicate, in mounted configuration, with the pressure relief valve.
PCT/EP2013/050438 2012-01-12 2013-01-11 Device for protecting the needle of a syringe WO2013104736A1 (en)

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FR1250326A FR2985669B1 (en) 2012-01-12 2012-01-12 DEVICE FOR PROTECTING THE NEEDLE OF A SYRINGE
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US11744775B2 (en) 2016-09-30 2023-09-05 Icu Medical, Inc. Pressure-regulating vial access devices and methods
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FR2985669A1 (en) 2013-07-19

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