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WO2009004205A2 - Device for injecting a liquid into a body - Google Patents

Device for injecting a liquid into a body Download PDF

Info

Publication number
WO2009004205A2
WO2009004205A2 PCT/FR2008/050990 FR2008050990W WO2009004205A2 WO 2009004205 A2 WO2009004205 A2 WO 2009004205A2 FR 2008050990 W FR2008050990 W FR 2008050990W WO 2009004205 A2 WO2009004205 A2 WO 2009004205A2
Authority
WO
WIPO (PCT)
Prior art keywords
needle
extraction
base
compressible envelope
envelope
Prior art date
Application number
PCT/FR2008/050990
Other languages
French (fr)
Other versions
WO2009004205A3 (en
Inventor
Eric Perouse
Original Assignee
Laboratoires Perouse
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 Laboratoires Perouse filed Critical Laboratoires Perouse
Publication of WO2009004205A2 publication Critical patent/WO2009004205A2/en
Publication of WO2009004205A3 publication Critical patent/WO2009004205A3/en

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/158Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/158Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
    • A61M2005/1583Needle extractors
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/22Valves or arrangement of valves
    • A61M39/26Valves closing automatically on disconnecting the line and opening on reconnection thereof
    • A61M2039/263Valves closing automatically on disconnecting the line and opening on reconnection thereof where the fluid space within the valve is decreasing upon disconnection
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M2209/00Ancillary equipment
    • A61M2209/04Tools for specific apparatus
    • A61M2209/045Tools for specific apparatus for filling, e.g. for filling reservoirs
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02Access sites
    • A61M39/0208Subcutaneous access sites for injecting or removing fluids

Definitions

  • the present invention relates to a device for injecting a liquid into a body, in particular the body of a patient, of the type comprising:
  • a needle extraction assembly comprising a needle protection armature delimiting an interior volume; the needle holder being displaceable with respect to the protective armature during the extraction of the needle between a use position, in which the needle projects out of the inner volume and an extraction position in which the needle is received in the inner volume; the extraction assembly having a bearing surface on the body, and a contact surface adapted to come into contact with at least one finger of an operator to exert a holding force of the bearing surface against the body the holding force being directed towards the body during the relative movement of the needle support relative to the protective armature between the use position and the extraction position; the device further comprising:
  • a compressible envelope for generating an overpressure in the injection passage.
  • a chamber disposed under the skin. This chamber is extended by a catheter running through the vein or artery to where the drug dose is to be distributed.
  • the implantable chamber comprises a reservoir having a pierceable septum along its surface in contact with the skin.
  • the needle of the device is engaged through the patient's skin in the implantable chamber and the drug dose is injected into this chamber through the needle.
  • an injection device is commonly used comprising a support integral with the needle.
  • the support is extended by a pipe whose end is connected to the injection needle and the other end is equipped with a connector for connecting a syringe or a reservoir of a dose to be injected .
  • the practitioner grasps the support of the device and pulls the needle out of the patient's support.
  • the injection device is commonly provided with an extraction assembly comprising a needle protection structure which receives the needle during its extraction to prevent the practitioner from pricking himself.
  • a temporary depression is generated in the implantable chamber, in particular when the perforable septum is pulled out of the body by the needle, during the initial phase of the extraction.
  • the catheters used have an internal diameter ranging from 1.57 mm to 0.65 mm. If we reason in terms of corresponding displacement at the distal end of the catheter, we obtain:
  • This depression can also lead to deposition of fibrin (or other materials) which in the long run will lead to a decrease in the flow of implantable chambers that can go as far as obstruction. The chamber must therefore be replaced frequently.
  • FR-A-2 886 857 discloses a device of the aforementioned type, in which means for generating an overpressure are provided in the extraction assembly in order to generate an overpressure during extraction. .
  • An object of the invention is to provide an injection device that compensates for the body fluid reflux during the removal of the needle, especially during the initial phase of the extraction.
  • the invention relates to an injection device of the aforementioned type, characterized in that the compressible envelope is stacked mechanically between the contact surface and the bearing surface, to be compressed by the application, on the contact surface, of said holding force when the bearing surface is in contact with the body, during the relative movement of the needle holder with respect to the protective armature.
  • the invention may include one or more of the following features, taken singly or in any technically possible combination:
  • the extraction assembly has a lower surface for activating the overpressure, intended to be directed towards the body, the compressible envelope projecting towards the body from the activation surface during the extraction of the needle, the application of the holding force being able to cause compression of the compressible envelope between the lower surface and an additional surface substantially parallel to the lower surface;
  • the assembly comprises a support plate, integral with the compressible envelope and designed to be applied against the body, the compressible envelope being compressed between the activation surface and the support plate during the application of the sustaining force;
  • the compressible envelope delimits a portion of the bearing surface, the compressible envelope being compressed between the activation surface and the body during the application of the holding force;
  • the compressible envelope protrudes away from the body with respect to an upper surface of the extraction assembly, the contact surface being delimited at least partially by the compressible envelope to be compressed between the finger of a operator and the upper surface when applying the holding force;
  • the device comprises an injection catheter connected at one end to the needle support and opening into the injection passage of the needle, the compressible envelope being formed by a flexible section of the injection catheter;
  • the protective armature is movable relative to the needle holder along an axis YY 'of extraction, the injection needle having a main portion which projects relative to the needle holder along the axis of extraction Y-Y ', and the compressible envelope is mounted slidably movable along the main section along the extraction axis YY' through a sliding fastener;
  • the extraction assembly comprises a base mounted on the needle holder and a pusher slidably mounted in the base, the pusher at least partially defining the contact surface;
  • the extraction assembly comprises a base intended to be placed facing the body, the armature comprising a linkage deployable away from the body from the base between a folded configuration on the base in the vicinity of the body and a deployed configuration away from the base away from the body, the linkage connecting the needle holder to the base;
  • FIG. 1 is a perspective view of three-quarter faces of an injection device implanted in a human body, during the injection of liquid into an implantable chamber;
  • FIG. 2 is a view similar to Figure 1, at the beginning of the extraction of the needle holder;
  • FIG. 3 is a view taken in section along the median vertical plane III-III of FIG. 2;
  • - Figure 4 is a partial sectional side view of the device of Figure 1 during the extraction of the needle;
  • FIG. 5 is a view similar to Figure 2 of a second injection device according to the invention.
  • FIG. 6 is a view similar to Figure 3 of a third injection device according to the invention.
  • FIGS. 1 to 4 show a first injection device 10 according to the invention connected to an implantable chamber 12.
  • the chamber 12 is disposed under the skin noted 14 in the body of a patient.
  • the chamber 12 has a generally cylindrical reservoir 16 delimited, on its face in contact with the inner surface of the skin, by a pierceable membrane 18 visible in FIG. 3.
  • the reservoir 16 is connected to a pipe
  • the injection device 10 comprises, as known per se, a needle 22 solid with a needle holder 24 extended by an injection catheter 26 connected to the needle. 22.
  • the extraction device 10 further comprises an extraction mechanism 27 of the needle 22, and means 28 for generating an excess pressure in the chamber 12 during the extraction of the needle 22.
  • the needle 22 has a free end curved point 29, so that it opens laterally relative to the general axis of the needle. It delimits internally a liquid injection passage.
  • the support 24 comprises an elongated and generally cylindrical central core 30 traversed right through by an axial lumen for conveying the liquid to the needle 22.
  • the needle 22 is secured to one end of the core 30 which forms a head 32.
  • the needle 22 forms an extended elbow 34 on the side of the tip 29 by a main section 35 of vertical axis YY 'and, on the opposite side to the tip 29, by a perpendicular connecting section 36 engaged in the axial lumen passing through the 30, from the head 32. At its other end, the light is extended in a pin 38 ensuring the connection of the catheter 26.
  • the support 24 On the side of the support facing the needle 22, the support 24 comprises a support plate 42 extending along the length of the support, with the exception of the end end region 32 which protrudes with respect to this support plate 42.
  • the mechanism 27 for extracting the needle 22 is permanently connected to the needle support 24 by being movable relative thereto between an inactive position of the extraction mechanism as illustrated by FIG. 1 and a position active extraction mechanism as shown in Figure 2 to 4.
  • the extraction mechanism 27 comprises a base 52 and a pusher 54 slidably mounted relative to the base 52.
  • the base 52 is displaceable with respect to the support 24 and is articulated in particular with respect thereto.
  • an axis XX ' extending perpendicular to the plane of the curved needle 22, horizontally in the Figures.
  • the base 52 is formed of a sleeve 56 defining a passage 58 of the pusher 54.
  • the sleeve 56 is open laterally along a generatrix over a width corresponding to the width of the central core 30 of the support. On either side of this opening, the sleeve is extended by two flanks 60 adapted to engage around the central core 30.
  • Projection profiles are complementary recesses 61 A, 61 B of elastic engagement are provided on the sidewalls 60 and the support 24 to ensure a temporary immobilization of the extraction mechanism 27, both in its active position and in its position inactive.
  • the sleeve 54 externally has two radial protrusions forming finger support 64.
  • the pusher 54 is formed of a rod 70 generally hollowed out and open at a so-called front end 71A facing the needle 22.
  • the rod 70 defines a cylindrical internal volume 73 for receiving the needle 22, closed at the rear end 71 B of the rod 70 by a fingerrest 72.
  • the rod 70 is open, from its front end 71 A, by a slot 74 extending along the length of the pusher over most of the length thereof. The width of the slot 74 is sufficient to receive the central core 30.
  • the slot opens into the volume 73.
  • the pusher 54 defines a substantially planar annular surface 76 for activating the generating means 28. an overpressure.
  • This activation surface 76 defines, towards the axis YY 'of the rod, an opening opening into the internal volume 73 of the rod 70, for the passage of the needle 22.
  • the surface 76 is delimited away from the axis YY 'by the sleeve 56.
  • the activation surface 76 extends facing the skin 14 towards it, when the extraction mechanism 27 occupies its active position, substantially perpendicular to the axis Y- Y '.
  • the finger support 72 defines an upper surface 78 which has a concavity directed away from the skin 14.
  • the upper surface 78 is intended to come into contact with the practitioner's fingers, particularly with his thumb, to exert a force applying and maintaining the extraction mechanism 27 against the skin 14, as will be seen below.
  • the pusher 54 is slidably received inside the passage 58 delimited by the base 52, between a position of use of the needle, as illustrated in FIGS. 2 to 4, and an extraction position of the needle. needle, along an extraction axis which is parallel to or coincident with the axis YY 'of the main section 35.
  • the open end 71A of the pusher In the position of use of the needle, the open end 71A of the pusher is situated in the vicinity of the base 24, whereas in the extraction position, the end 71 B closed by the pusher 54 is located at near the base 52, the open end 71A extending beyond the tip 29 of the needle.
  • the base 52 and the pusher 54 further include complementary resilient latching elements 80 capable of ensuring temporary retention of the pusher in its two extreme positions of use and extraction.
  • the catheter 26 comprises a flexible tube 84 which connects, upstream, a reservoir (not shown) of liquid to be injected, and downstream, the nipple 38.
  • the tube 84 is provided, between the reservoir and the core 30, a clamp (not shown) able to selectively close the catheter 26 upstream of the device 10.
  • the means 28 for generating an overpressure comprise a compressible envelope containing fluid, and a support rider 88 for supporting the envelope, applied to the skin 14 and slidably engaged around the needle 22.
  • the compressible envelope is formed by a flexible section 86 of the injection catheter 26 engaged under the pusher 54.
  • the rider 88 comprises a support plate 90 applied to the skin 14, and two stirrups 92 for holding the flexible section 86.
  • the plate 90 delimits, directed towards the skin 14, a surface 94 of support on the skin, and opposite the bearing surface 94, an upper surface 96 for supporting the flexible section 86.
  • the plate 90 further defines a notch 98 for receiving the needle 22 opening into a rear edge 100 of the plate 90 located opposite of the support plate 42.
  • the notch 98 comprises a central orifice 102 of substantially circular section and a slot 104 of smaller transverse dimension than that of the central orifice 102. the slot 104 opens into the edge 100, substantially in the the axis of the central core 30 when the needle 22 is received in the central orifice 102.
  • the stirrups 92 are placed on either side of the plate 90. They protrude away from the skin 14 from the upper surface 96.
  • the stirrups 92 are arranged opposite one another and are spaced along an axis perpendicular to the axis of the core 30.
  • the flexible section 86 is engaged through the stirrups 92 which maintain it bearing on the upper surface 96.
  • the flexible portion 86 is interposed between the activation surface 76 at the open end 71A of the pusher 54 and the upper surface 96 of the rider 88, as shown in FIG.
  • the jumper 88 is movable relative to the needle 22 between a configuration of use of the needle 22, in which the needle 22 is placed away from the notch 98 and an extraction configuration, in which the main section 35 of the needle 22 has been inserted through the slot 104 into the orifice 102.
  • the rider 88 is free to slide around the needle 22 in the orifice 102, the along the Y-Y 'axis.
  • the extraction mechanism 27 is placed in its inactive position with the pusher 54 extending generally perpendicular to the main section 35 of the needle 22, being pressed along the length of the central core 30. In this position, the flanks 60 of the base 52 apply to the plate 42.
  • the pusher 54 is then in its position of use of the needle so that the head 30 is visible.
  • the jumper 88 is maintained in its configuration of use of the needle, away from the needle 22.
  • the needle 22 of the injection device 10 is inserted into an implantable chamber 12 and is depressed until the plate 42 bears on the skin of the patient.
  • the presence of the extraction mechanism 27 folded along the length of the central core of the needle holder is not a problem for handling.
  • the pusher 54 being folded along the central core it does not protrude along its entire length relative to the skin 14 of the patient, so that the injection device 10, after placement, can be easily held by tape.
  • the jumper 88 is moved from its configuration of use to its extraction configuration.
  • the practitioner winds the catheter 26 around the needle support 24 to bring the flexible section 86 and the rider 88 to the front of the core 30 opposite the head 32.
  • the main section 35 of the needle 22 is introduced into the notch 98 through the slot 104 by moving the rider 88 towards the support plate 42 of the needle holder 24.
  • the lower bearing surface 96 of the jumper 88 is then placed in contact with the skin 14, as illustrated in FIG.
  • the extraction mechanism 27 is straightened by being brought into its active position.
  • the base 52 and the pusher 54 are tilted about the axis XX 'to be brought into the position shown in Figures 2 and 3.
  • the pusher 54 is then placed in the axis YY' of the main section 35 of the needle, and the two extensions 64 extend generally perpendicular to the Y-Y 'axis.
  • the head 32 of the support is received in the recessed pusher 54.
  • the extraction mechanism 27 extends over the jumper 88 and the flexible section 86, which it partially covers.
  • the sleeve 56 is placed between the stirrups 92 and rests partially in abutment on the flexible section 86.
  • the activation surface 76 of the pusher 54 is placed in abutment on the flexible section 86, without compressing it, or by compressing it slightly.
  • the flexible section 86 is thus interposed between two surfaces 76, 96 of the extraction mechanism, substantially perpendicular to the axis YY 'of application of the holding force, in contact with these surfaces 76, 96.
  • a continuous mechanical stack is thus produced along the Y-Y 'axis, between the bearing surface 94 on the skin 14, located under the rider 88 and the contact surface 78 with the practitioner's fingers, located on the support 72, via successively the plate 90, the flexible section 86 and the rod 70.
  • This stack forms a force transmission chain from the contact surface 78 to the bearing surface 94.
  • the generating means 28 are inactive, and fluid is able to flow freely through the flexible section which has a substantially maximum inner section .
  • the practitioner closes the catheter 26 by activating the clamp located upstream of the flexible section 86. It then applies two fingers on either side of the base 52 under the finger-rest 64 and applies another finger, for example its thumb, on the contact surface 78. Then, it exerts on the surface 78 a holding force axis YY 'directed towards the skin 14 to cause the displacement of the pusher 54 towards the skin 14 relative to the base 52 .
  • the displacement of the pusher 54 downward under the effect of the holding force applied to the contact surface 78 causes the compression of the flexible section 86 by the activation surface 76 until the section 86 is crushed between the activation surface 76 and the upper surface 96.
  • the inner section of the flexible section 86 is then minimal.
  • the holding force exerted by the practitioner on the contact surface 78 is transmitted to the bearing surface 94 by mechanical stacking, which maintains the bearing surface 94 applied against the skin 14 during the extraction of the 'needle.
  • the crushing of the flexible section 86 between two surfaces 76, 96 substantially perpendicular to the axis YY 'extraction generates an overpressure in the injection passage of the needle 22, which is transmitted to the chamber 16 and in the conduit 20, to compensate the reflux of biological fluid in the pipe 20.
  • the volume of liquid displaced to the chamber during compression of the flexible section is thus greater than the volume normally aspirated during the withdrawal, for example greater than 7 .mu.l and preferably greater than 17 .mu.l.
  • the flexible section 86 is compressed exclusively under the effect of the application of the holding force, when the contact surface 96 is placed in contact with the body 14. In the absence of contact between the contact surface 96 and the body 14, and in the absence of application of the holding force, the flexible section 86 is not compressed.
  • the operator pulls the base 52 away from the skin 14 along the pusher 54.
  • the displacement of the sleeve 56 of the base causes that of the needle holder 24 from its position of use of the needle, in which the needle 22 projects out of the tube 70 and the inner volume 73 beyond the front end 71A, towards the extraction position of the needle.
  • the needle 22 is gradually swallowed in the internal volume 73, as illustrated by the intermediate position shown in FIG. 4.
  • the practitioner permanently exerts against the skin 14, a holding force axis YY 'directed towards the skin 14 via the pusher 54 and the rider 88. This force prevents the chamber 12 to go up upwards and thus limits the pain felt by the patient during extraction.
  • the needle 22 In the extraction position, the needle 22 has been totally swallowed inside the pusher 54.
  • the main section 35 of the needle thus extends completely into the internal volume 73 of the pusher 54 and is protected, particularly at level of its tip 29, which avoids any risk of accidental prick of the practitioner.
  • the second device 1 10 according to the invention shown in Figure 5 differs from the first device 10 in that the flexible section 86 is fixed in abutment on the finger rest 72.
  • the flexible section 86 and the finger rest 72 form therefore each a part of the contact surface 78 with the finger of the operator.
  • the bearing surface on the skin 14 is formed by the lower annular surface 76 of the pusher 54.
  • a mechanical stack is produced between the contact surface 78 and the bearing surface 76 on the skin 14 via the flexible section 86, of the finger support 72, and the pusher 54.
  • the overpressure in the injection passage is generated when the operator's finger exerts the holding force, by crushing the flexible section 86 between his finger and the upper surface 78.
  • a wheel or a piston is arranged on the finger rest 72 in order to cover the flexible section facing the upper surface 78.
  • the flexible section 86 is thus interposed between the wheel or the piston and the upper surface 78, to be compressed by displacement of the wheel or the piston towards the upper surface 78 during the application of the holding force along the axis YY '.
  • a third device 140 according to the invention is shown in FIGS. 6 and 7. This third device 140 differs from the first device 10 by the nature of the extraction mechanism 27.
  • the extraction mechanism 27 comprises a lower base 142 and a deployable linkage 144 of protection connecting the base 142 to the support 24.
  • the base 142 delimits a substantially flat lower surface 146, an upper surface 148, and a slot 150 connecting the lower surface 146 to the upper surface 148 for the passage of the main section 35 of the needle 22.
  • the upper surface 148 is extends across the support 24.
  • the protection linkage 144 comprises, on either side of the support 24, two pairs of panels 150A, 150B.
  • the panels 150A, 150B of each pair are hinged together by a horizontal hinge 152.
  • the panels 150A, 150B are also articulated by horizontal hinges respectively on the support 24 and on the base 142.
  • the panels 150A, 150B form with the support 24 and the base 142 a section of vertical section diamond-shaped 154, deployable between an elongate position substantially parallel to the skin 14, for the use of the needle (Figure 6), and an elongated position perpendicular to the skin 14, for the extraction of the needle (Figure 7).
  • the distance between the hinges 152 on either side of the support 24 and the base 142 is maximum, while in the extraction position, this distance is minimal.
  • the rhombic section section 154 defines an interior needle protection volume 156.
  • the main section 35 of the needle 22 projects through the opening 149 out of the internal volume 156.
  • the main section 35 and the tip 29 are completely received in the internal volume 156 between the support 24 and the base 142.
  • the hinges 152 also define contact surfaces with the fingers of the operator.
  • the means 28 for generating an overpressure comprise a flexible section 86 of the catheter 26 fixed under the lower surface 146, to be interposed between this surface 146 and the skin 14.
  • the flexible section 86 is placed in contact with the skin 14. It thus partially defines, with the lower surface 146, the bearing surface on the skin 14.
  • the needle 22 is planted through the skin 14, keeping the mechanism 27 in its position of use of the needle. In this position, the flexible section 86 is maintained, with a maximum inner section, between the lower surface 146 and the skin 14.
  • the operator grasps contact surfaces on the hinges 152. He then applies a holding force directed towards the skin 14 to exert a bearing on the skin 14. This holding force causes the compression of the flexible portion 86 between the skin 14 and the surface 146, and the generation of an overpressure in the needle 22 and in the chamber 16.
  • the operator brings the hinges 152 closer together, which progressively moves the support 24 away from the base 142 away from the skin 14.
  • the needle 22 is swallowed progressively at through the opening 149 in the interior volume 156 to the extraction position shown in FIG. 7, in which it is totally received in the interior volume 156.

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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

According to the invention, the device (10) includes a needle holder (24) and an extraction assembly (27) comprising a needle protection armature (54) defining an inner volume. The holder (24) is movable relative to the armature (54) between an injection position and an extraction position of the needle. The device (10) includes a compressible envelope (28) for generating an overpressure in the injection passage of the needle (22). The envelope (28) is mechanically stacked between a contact surface (78) with the finger of an operator and a surface bearing against the body (14) to be compressed by the application on the contact surface of a force for maintaining the bearing surface against the body (14) when the bearing surface is in contact with the body (14) when withdrawing the needle.

Description

Dispositif d'injection d'un liquide dans un corps. Device for injecting a liquid into a body
La présente invention concerne un dispositif d'injection d'un liquide dans un corps, notamment le corps d'un patient, du type comprenant :The present invention relates to a device for injecting a liquid into a body, in particular the body of a patient, of the type comprising:
- un support d'aiguille portant une aiguille d'injection destinée à être piquée dans le corps, l'aiguille d'injection délimitant un passage d'injection ;- a needle holder carrying an injection needle to be stitched into the body, the injection needle defining an injection passage;
- un ensemble d'extraction de l'aiguille comprenant une armature de protection d'aiguille délimitant un volume intérieur; le support d'aiguille étant déplaçable par rapport à l'armature de protection lors de l'extraction de l'aiguille entre une position d'utilisation, dans laquelle l'aiguille fait sail- lie hors du volume intérieur et une position d'extraction, dans laquelle l'aiguille est reçue dans le volume intérieur; l'ensemble d'extraction présentant une surface d'appui sur le corps, et une surface de contact apte à entrer en contact avec au moins un doigt d'un opérateur pour exercer une force de maintien de la surface d'appui contre le corps, la force de maintien étant dirigée vers le corps lors du déplacement relatif du support d'aiguille par rapport à l'armature de protection entre la position d'utilisation et la position d'extraction ; le dispositif comprenant en outre :a needle extraction assembly comprising a needle protection armature delimiting an interior volume; the needle holder being displaceable with respect to the protective armature during the extraction of the needle between a use position, in which the needle projects out of the inner volume and an extraction position in which the needle is received in the inner volume; the extraction assembly having a bearing surface on the body, and a contact surface adapted to come into contact with at least one finger of an operator to exert a holding force of the bearing surface against the body the holding force being directed towards the body during the relative movement of the needle support relative to the protective armature between the use position and the extraction position; the device further comprising:
- une enveloppe compressible de génération d'une surpression dans le passage d'injection. Dans certaines pathologies, il est nécessaire d'injecter quotidiennement une dose médicamenteuse liquide directement dans un organe d'un patient. Pour ce faire, il est connu d'implanter à demeure, sur la poitrine du patient, une chambre disposée sous la peau. Cette chambre est prolongée par un cathéter cheminant dans la veine ou l'artère jusqu'à l'endroit où la dose médicamenteuse doit être distribuée. La chambre implantable comporte un réservoir présentant un septum perforable suivant sa surface en contact avec la peau.a compressible envelope for generating an overpressure in the injection passage. In certain pathologies, it is necessary to inject a liquid drug dose daily directly into a patient's organ. To do this, it is known to implant permanently, on the chest of the patient, a chamber disposed under the skin. This chamber is extended by a catheter running through the vein or artery to where the drug dose is to be distributed. The implantable chamber comprises a reservoir having a pierceable septum along its surface in contact with the skin.
Pour l'injection de la dose médicamenteuse, l'aiguille du dispositif est engagée à travers la peau du patient dans la chambre implantable et la dose médicamenteuse est injectée dans cette chambre au travers de l'aiguille. Pour procéder à de telles injections, on utilise couramment un dispositif d'injection comportant un support solidaire de l'aiguille. Le support est prolongé par un tuyau dont une extrémité est reliée à l'aiguille d'injection et dont l'autre extrémité est équipée d'un connecteur permettant la connexion d'une seringue ou d'un réservoir d'une dose médicamenteuse à injecter. Pour extraire l'aiguille de la chambre implantable, le praticien saisit le support du dispositif et tire l'aiguille hors du support du patient.For injection of the drug dose, the needle of the device is engaged through the patient's skin in the implantable chamber and the drug dose is injected into this chamber through the needle. To carry out such injections, an injection device is commonly used comprising a support integral with the needle. The support is extended by a pipe whose end is connected to the injection needle and the other end is equipped with a connector for connecting a syringe or a reservoir of a dose to be injected . To extract the needle from the implantable chamber, the practitioner grasps the support of the device and pulls the needle out of the patient's support.
La force déployée par le praticien pour extraire l'aiguille est relativement importante, de sorte que le risque de piqûre est élevé lorsque l'aiguille sort de la peau. Pour éviter ce risque, le dispositif d'injection est couramment muni d'un ensemble d'extraction comprenant une structure de protection d'aiguille qui reçoit l'aiguille lors de son extraction pour éviter que le praticien ne se pique.The force deployed by the practitioner to extract the needle is relatively large, so that the risk of sting is high when the needle comes out of the skin. To avoid this risk, the injection device is commonly provided with an extraction assembly comprising a needle protection structure which receives the needle during its extraction to prevent the practitioner from pricking himself.
Lors de l'extraction de l'aiguille, une dépression temporaire est engendrée dans la chambre implantable, notamment lorsque le septum perforable est tiré vers l'extérieur du corps par l'aiguille, lors de la phase initiale de l'extraction.During the extraction of the needle, a temporary depression is generated in the implantable chamber, in particular when the perforable septum is pulled out of the body by the needle, during the initial phase of the extraction.
Des essais in vitro ont été réalisés pour mesurer le déplacement de volume en bout de cathéter lors du retrait de l'aiguille.In vitro tests were performed to measure volume displacement at the tip of the catheter during needle removal.
Lors du retrait de l'aiguille, celle-ci adhère au septum qui se soulève, le volume interne de la chambre augmente créant ainsi une forte aspiration. Cette aspiration se retrouve en bout de cathéter. Puis l'aiguille sortant davantage du septum, l'effet d'adhérence décroît, le septum reprend alors sa forme initiale et le volume interne de la chambre diminue sans arriver à sa valeur initiale. Il reste alors un volume résiduel en bout de cathéter pouvant entraîner l'obstruction du cathéter.When removing the needle, it adheres to the septum that rises, the internal volume of the chamber increases creating a strong suction. This aspiration is found at the end of the catheter. Then the needle exiting more of the septum, the adhesion effect decreases, the septum then returns to its original shape and the internal volume of the chamber decreases without reaching its initial value. There is then a residual volume at the end of the catheter that can cause obstruction of the catheter.
Les essais ont montré que l'aspiration maximale peut monter jusqu'à 17μl. Le volume résiduel pour sa part peut aller jusqu'à 7μl.Tests have shown that the maximum suction can rise to 17μl. The residual volume for its part can go up to 7μl.
Généralement les cathéters utilisés ont un diamètre interne allant de 1 ,57mm à 0,65mm. Si on raisonne en terme de déplacement correspondant en extrémité distale du cathéter on obtient :Generally, the catheters used have an internal diameter ranging from 1.57 mm to 0.65 mm. If we reason in terms of corresponding displacement at the distal end of the catheter, we obtain:
- Pour 17μl un déplacement variant de 8 à 50mm - Pour 7μl un déplacement variant de 6mm à 20mm.- For 17μl a displacement varying from 8 to 50mm - For 7μl a displacement varying from 6mm to 20mm.
Cette dépression peut également entraîner un dépôt de fibrine (ou d'autres matériaux) qui à terme va entraîner une baisse du débit des chambres implantables pouvant aller jusqu'à l'obstruction. La chambre doit donc être remplacée fréquemment.This depression can also lead to deposition of fibrin (or other materials) which in the long run will lead to a decrease in the flow of implantable chambers that can go as far as obstruction. The chamber must therefore be replaced frequently.
Pour pallier ce problème, on connaît de FR-A-2 886 857 un dispositif du type précité, dans lequel des moyens de génération d'une surpression sont prévus dans l'ensemble d'extraction pour générer une surpression au cours de l'extraction.To overcome this problem, FR-A-2 886 857 discloses a device of the aforementioned type, in which means for generating an overpressure are provided in the extraction assembly in order to generate an overpressure during extraction. .
Un but de l'invention est de disposer d'un dispositif d'injection qui permette de compenser le reflux de fluide corporel lors du retrait de l'aiguille, notamment lors de la phase initiale de l'extraction. A cet effet, l'invention a pour objet un dispositif d'injection du type précité, caractérisé en ce que l'enveloppe compressible est empilée mécaniquement entre la surface de contact et la surface d'appui, pour être comprimée par l'application, sur la surface de contact, de ladite force de maintien lorsque la surface d'appui est en contact avec le corps, pendant le déplacement relatif du support d'aiguille par rapport à l'armature de protection.An object of the invention is to provide an injection device that compensates for the body fluid reflux during the removal of the needle, especially during the initial phase of the extraction. For this purpose, the invention relates to an injection device of the aforementioned type, characterized in that the compressible envelope is stacked mechanically between the contact surface and the bearing surface, to be compressed by the application, on the contact surface, of said holding force when the bearing surface is in contact with the body, during the relative movement of the needle holder with respect to the protective armature.
L'invention peut comprendre l'une ou plusieurs des caractéristiques suivantes, prise(s) isolément ou suivant toutes combinaisons techniquement possibles :The invention may include one or more of the following features, taken singly or in any technically possible combination:
- l'ensemble d'extraction présente une surface inférieure d'activation de la sur- pression, destinée à être dirigée vers le corps, l'enveloppe compressible faisant saillie vers le corps à partir de la surface d'activation lors de l'extraction de l'aiguille, l'application de la force de maintien étant apte à provoquer la compression de l'enveloppe compressible entre la surface inférieure et une surface additionnelle sensiblement parallèle à la surface inférieure ; - l'ensemble comprend une plaque d'appui, solidaire de l'enveloppe compressible et destinée à être appliquée contre le corps, l'enveloppe compressible étant comprimée entre la surface d'activation et la plaque d'appui lors de l'application de la force de maintien ;the extraction assembly has a lower surface for activating the overpressure, intended to be directed towards the body, the compressible envelope projecting towards the body from the activation surface during the extraction of the needle, the application of the holding force being able to cause compression of the compressible envelope between the lower surface and an additional surface substantially parallel to the lower surface; the assembly comprises a support plate, integral with the compressible envelope and designed to be applied against the body, the compressible envelope being compressed between the activation surface and the support plate during the application of the sustaining force;
- l'enveloppe compressible délimite une partie de la surface d'appui, l'enveloppe compressible étant comprimée entre la surface d'activation et le corps lors de l'application de la force de maintien ;the compressible envelope delimits a portion of the bearing surface, the compressible envelope being compressed between the activation surface and the body during the application of the holding force;
- l'enveloppe compressible fait saillie à l'écart du corps par rapport à une surface supérieure de l'ensemble d'extraction, la surface de contact étant délimitée au moins partiellement par l'enveloppe compressible pour être comprimée entre le doigt d'un opé- rateur et la surface supérieure lors de l'application de la force de maintien ;the compressible envelope protrudes away from the body with respect to an upper surface of the extraction assembly, the contact surface being delimited at least partially by the compressible envelope to be compressed between the finger of a operator and the upper surface when applying the holding force;
- le dispositif comporte un cathéter d'injection raccordé à une extrémité sur le support d'aiguille et débouchant dans le passage d'injection de l'aiguille, l'enveloppe compressible étant formée par un tronçon souple du cathéter d'injection ;the device comprises an injection catheter connected at one end to the needle support and opening into the injection passage of the needle, the compressible envelope being formed by a flexible section of the injection catheter;
- l'armature de protection est déplaçable par rapport au support d'aiguille suivant un axe Y-Y' d'extraction, l'aiguille d'injection présentant un tronçon principal qui fait saillie par rapport au support d'aiguille suivant l'axe d'extraction Y-Y', et l'enveloppe compressible est montée déplaçable à coulissement le long du tronçon principal suivant l'axe d'extraction Y-Y' par l'intermédiaire d'une attache coulissante ; - l'ensemble d'extraction comprend une embase montée sur le support d'aiguille et un poussoir monté coulissant dans l'embase, le poussoir délimitant au moins partiellement la surface de contact ;- The protective armature is movable relative to the needle holder along an axis YY 'of extraction, the injection needle having a main portion which projects relative to the needle holder along the axis of extraction Y-Y ', and the compressible envelope is mounted slidably movable along the main section along the extraction axis YY' through a sliding fastener; - The extraction assembly comprises a base mounted on the needle holder and a pusher slidably mounted in the base, the pusher at least partially defining the contact surface;
- l'ensemble d'extraction comprend une base destinée à être placée en regard du corps, l'armature comprenant une tringlerie déployable à l'écart du corps à partir de la base entre une configuration repliée sur la base au voisinage du corps et une configuration déployée à l'écart de la base à l'écart du corps, la tringlerie raccordant le support d'aiguille à la base ;the extraction assembly comprises a base intended to be placed facing the body, the armature comprising a linkage deployable away from the body from the base between a folded configuration on the base in the vicinity of the body and a deployed configuration away from the base away from the body, the linkage connecting the needle holder to the base;
- l'enveloppe compressible est fixée sous la base. L'invention sera mieux comprise à la lecture de la description qui va suivre, donné uniquement à titre d'exemple, et faite en se référant aux dessins annexés sur lesquels :- the compressible envelope is fixed under the base. The invention will be better understood on reading the description which follows, given solely by way of example, and with reference to the appended drawings, in which:
- la Figure 1 est une vue en perspective de trois-quarts face d'un dispositif d'injection implanté dans un corps humain, lors de l'injection de liquide dans une cham- bre implantable ;FIG. 1 is a perspective view of three-quarter faces of an injection device implanted in a human body, during the injection of liquid into an implantable chamber;
- la Figure 2 est une vue analogue à la Figure 1 , au début de l'extraction du support d'aiguille ;- Figure 2 is a view similar to Figure 1, at the beginning of the extraction of the needle holder;
- la Figure 3 est une vue prise en coupe suivant le plan vertical médian Ill-lll de la Figure 2 ; - la Figure 4 est une vue de côté en coupe partielle du dispositif de la Figure 1 au cours de l'extraction de l'aiguille ;FIG. 3 is a view taken in section along the median vertical plane III-III of FIG. 2; - Figure 4 is a partial sectional side view of the device of Figure 1 during the extraction of the needle;
- la Figure 5 est une vue analogue à la Figure 2 d'un deuxième dispositif d'injection selon l'invention ;- Figure 5 is a view similar to Figure 2 of a second injection device according to the invention;
- la Figure 6 est une vue analogue à la Figure 3 d'un troisième dispositif d'injection selon l'invention ;- Figure 6 is a view similar to Figure 3 of a third injection device according to the invention;
- la Figure 7 est une vue analogue à la Figure 6, après extraction de l'aiguille. Sur les Figures 1 à 4 est représenté un premier dispositif d'injection 10 selon l'invention, relié à une chambre implantable 12.- Figure 7 is a view similar to Figure 6, after extraction of the needle. FIGS. 1 to 4 show a first injection device 10 according to the invention connected to an implantable chamber 12.
Comme visible sur les Figures, la chambre 12 est disposée sous la peau notée 14 dans le corps d'un patient. La chambre 12 présente un réservoir 16 généralement cylindrique délimité, sur sa face en contact avec la surface intérieure de la peau, par une membrane perforable 18 visible sur la Figure 3. Le réservoir 16 est relié à un tuyauAs shown in the Figures, the chamber 12 is disposed under the skin noted 14 in the body of a patient. The chamber 12 has a generally cylindrical reservoir 16 delimited, on its face in contact with the inner surface of the skin, by a pierceable membrane 18 visible in FIG. 3. The reservoir 16 is connected to a pipe
20 d'acheminement d'une solution médicamenteuse vers un organe malade.Delivering a drug solution to a diseased organ.
Le dispositif d'injection 10 comporte, comme connu en soi, une aiguille 22 soli- daire d'un support d'aiguille 24 prolongé par un cathéter d'injection 26 relié à l'aiguille 22. Le dispositif d'extraction 10 comporte en outre un mécanisme d'extraction 27 de l'aiguille 22, et des moyens 28 de génération d'une surpression dans la chambre 12 lors de l'extraction de l'aiguille 22.The injection device 10 comprises, as known per se, a needle 22 solid with a needle holder 24 extended by an injection catheter 26 connected to the needle. 22. The extraction device 10 further comprises an extraction mechanism 27 of the needle 22, and means 28 for generating an excess pressure in the chamber 12 during the extraction of the needle 22.
L'aiguille 22 présente une extrémité libre courbée en forme de pointe 29, de sorte que celle-ci débouche latéralement par rapport à l'axe général de l'aiguille. Elle délimite intérieurement un passage d'injection de liquide.The needle 22 has a free end curved point 29, so that it opens laterally relative to the general axis of the needle. It delimits internally a liquid injection passage.
Le support 24 comporte une âme centrale 30 allongée et généralement cylindrique traversée de part en part par une lumière axiale d'acheminement du liquide jusqu'à l'aiguille 22. L'aiguille 22 est solidarisée à une extrémité de l'âme 30 qui forme une tête 32.The support 24 comprises an elongated and generally cylindrical central core 30 traversed right through by an axial lumen for conveying the liquid to the needle 22. The needle 22 is secured to one end of the core 30 which forms a head 32.
L'aiguille 22 forme un coude 34 prolongé du côté de la pointe 29 par un tronçon principal 35 d'axe vertical Y-Y' et, du côté opposé à la pointe 29, par un tronçon perpendiculaire de liaison 36 engagé dans la lumière axiale traversant l'âme 30, depuis la tête 32. A son autre extrémité, la lumière est prolongée dans un téton 38 assurant la connexion du cathéter 26.The needle 22 forms an extended elbow 34 on the side of the tip 29 by a main section 35 of vertical axis YY 'and, on the opposite side to the tip 29, by a perpendicular connecting section 36 engaged in the axial lumen passing through the 30, from the head 32. At its other end, the light is extended in a pin 38 ensuring the connection of the catheter 26.
Du côté du support tourné vers l'aiguille 22, le support 24 comporte une platine d'appui 42 s'étendant suivant la longueur du support, à l'exception de la région d'extrémité formant tête 32 qui fait saillie par rapport à cette platine d'appui 42.On the side of the support facing the needle 22, the support 24 comprises a support plate 42 extending along the length of the support, with the exception of the end end region 32 which protrudes with respect to this support plate 42.
Le mécanisme 27 d'extraction de l'aiguille 22 est lié à demeure au support d'aiguille 24 en étant déplaçable par rapport à celui-ci entre une position inactive du mécanisme d'extraction telle qu'illustrée par la Figure 1 et une position active du mécanisme d'extraction telle qu'illustrée sur les Figure 2 à 4.The mechanism 27 for extracting the needle 22 is permanently connected to the needle support 24 by being movable relative thereto between an inactive position of the extraction mechanism as illustrated by FIG. 1 and a position active extraction mechanism as shown in Figure 2 to 4.
Le mécanisme d'extraction 27 comporte une embase 52 et un poussoir 54 monté coulissant par rapport à l'embase 52. L'embase 52 est déplaçable par rapport au sup- port 24 et est notamment articulée par rapport à celui-ci autour d'un axe X-X' s'étendant perpendiculairement au plan de l'aiguille courbe 22, horizontalement sur les Figures.The extraction mechanism 27 comprises a base 52 and a pusher 54 slidably mounted relative to the base 52. The base 52 is displaceable with respect to the support 24 and is articulated in particular with respect thereto. an axis XX 'extending perpendicular to the plane of the curved needle 22, horizontally in the Figures.
L'embase 52 est formée d'un manchon 56 délimitant un passage 58 de circulation du poussoir 54. Le manchon 56 est ouvert latéralement suivant une génératrice sur une largeur correspondant à la largeur de l'âme centrale 30 du support. De part et d'autre de cette ouverture, le manchon est prolongé par deux flancs 60 propres à s'engager autour de l'âme centrale 30.The base 52 is formed of a sleeve 56 defining a passage 58 of the pusher 54. The sleeve 56 is open laterally along a generatrix over a width corresponding to the width of the central core 30 of the support. On either side of this opening, the sleeve is extended by two flanks 60 adapted to engage around the central core 30.
Des profils en saillie sont en creux complémentaires 61 A, 61 B d'enclenchement élastique sont prévus sur les flancs 60 et le support 24 pour assurer une immobilisation temporaire du mécanisme d'extraction 27, à la fois dans sa position active et dans sa position inactive. A son extrémité opposée à la tête 32, le manchon 54 présente extérieurement deux excroissances radiales formant appui-doigt 64.Projection profiles are complementary recesses 61 A, 61 B of elastic engagement are provided on the sidewalls 60 and the support 24 to ensure a temporary immobilization of the extraction mechanism 27, both in its active position and in its position inactive. At its end opposite to the head 32, the sleeve 54 externally has two radial protrusions forming finger support 64.
Le poussoir 54 est formé d'une tige 70 généralement évidée et ouverte à une extrémité dite avant 71A tournée vers l'aiguille 22. La tige 70 délimite un volume intérieur 73 cylindrique de réception de l'aiguille 22, obturé à l'extrémité arrière 71 B de la tige 70 par un appui-doigt 72. La tige 70 est ouverte, depuis son extrémité avant 71 A, par une fente 74 s'étendant suivant la longueur du poussoir sur l'essentiel de la longueur de celui-ci. La largeur de la fente 74 est suffisante pour recevoir l'âme centrale 30. La fente débouche dans le volume 73. A son extrémité avant 71A, le poussoir 54 délimite une surface annulaire 76 sensiblement plane d'activation des moyens 28 de génération d'une surpression. Cette surface d'activation 76 définit, vers l'axe Y-Y' de la tige, une ouverture débouchant dans le volume intérieur 73 de la tige 70, pour le passage de l'aiguille 22. La surface 76 est délimitée à l'écart de l'axe Y-Y' par le manchon 56. La surface d'activation 76 s'étend en regard de la peau 14 vers celle-ci, lorsque le mécanisme d'extraction 27 occupe sa position active, sensiblement perpendiculairement à l'axe Y-Y'.The pusher 54 is formed of a rod 70 generally hollowed out and open at a so-called front end 71A facing the needle 22. The rod 70 defines a cylindrical internal volume 73 for receiving the needle 22, closed at the rear end 71 B of the rod 70 by a fingerrest 72. The rod 70 is open, from its front end 71 A, by a slot 74 extending along the length of the pusher over most of the length thereof. The width of the slot 74 is sufficient to receive the central core 30. The slot opens into the volume 73. At its front end 71A, the pusher 54 defines a substantially planar annular surface 76 for activating the generating means 28. an overpressure. This activation surface 76 defines, towards the axis YY 'of the rod, an opening opening into the internal volume 73 of the rod 70, for the passage of the needle 22. The surface 76 is delimited away from the axis YY 'by the sleeve 56. The activation surface 76 extends facing the skin 14 towards it, when the extraction mechanism 27 occupies its active position, substantially perpendicular to the axis Y- Y '.
L'appui-doigt 72 délimite une surface supérieure 78 qui présente une concavité dirigée à l'écart de la peau 14. La surface supérieure 78 est destinée à entrer en contact avec les doigts du praticien, notamment avec son pouce, pour exercer une force d'application et de maintien du mécanisme d'extraction 27 contre la peau 14, comme on le verra plus bas.The finger support 72 defines an upper surface 78 which has a concavity directed away from the skin 14. The upper surface 78 is intended to come into contact with the practitioner's fingers, particularly with his thumb, to exert a force applying and maintaining the extraction mechanism 27 against the skin 14, as will be seen below.
Le poussoir 54 est reçu coulissant à l'intérieur du passage 58 délimité par l'embase 52, entre une position d'utilisation de l'aiguille, telle qu'illustrée sur les Figures 2 à 4, et une position d'extraction de l'aiguille, le long d'un axe d'extraction qui est paral- lèle ou confondu avec l'axe Y-Y' du tronçon principal 35.The pusher 54 is slidably received inside the passage 58 delimited by the base 52, between a position of use of the needle, as illustrated in FIGS. 2 to 4, and an extraction position of the needle. needle, along an extraction axis which is parallel to or coincident with the axis YY 'of the main section 35.
Dans la position d'utilisation de l'aiguille, l'extrémité ouverte 71A du poussoir est située au voisinage de l'embase 24, alors que dans la position d'extraction, l'extrémité 71 B obturée par le poussoir 54 est située au voisinage de l'embase 52, l'extrémité ouverte 71A s'étendant au-delà de la pointe 29 de l'aiguille. L'embase 52 et le poussoir 54 comportent en outre des éléments 80 d'enclenchement élastique complémentaires propres à assurer une retenue temporaire du poussoir dans ses deux positions extrêmes d'utilisation et d'extraction.In the position of use of the needle, the open end 71A of the pusher is situated in the vicinity of the base 24, whereas in the extraction position, the end 71 B closed by the pusher 54 is located at near the base 52, the open end 71A extending beyond the tip 29 of the needle. The base 52 and the pusher 54 further include complementary resilient latching elements 80 capable of ensuring temporary retention of the pusher in its two extreme positions of use and extraction.
Le cathéter 26 comprend un tube souple 84 qui raccorde, en amont, un réservoir (non représenté) de liquide à injecter, et en aval, le téton 38. Le tube 84 est muni, entre le réservoir et l'âme 30, d'une pince (non représentée) apte à obturer sélectivement le cathéter 26 en amont du dispositif 10.The catheter 26 comprises a flexible tube 84 which connects, upstream, a reservoir (not shown) of liquid to be injected, and downstream, the nipple 38. The tube 84 is provided, between the reservoir and the core 30, a clamp (not shown) able to selectively close the catheter 26 upstream of the device 10.
Les moyens 28 de génération d'une surpression comprennent une enveloppe compressible contenant du fluide, et un cavalier 88 de support de l'enveloppe, appliqué sur la peau 14 et engagé à coulissement autour de l'aiguille 22.The means 28 for generating an overpressure comprise a compressible envelope containing fluid, and a support rider 88 for supporting the envelope, applied to the skin 14 and slidably engaged around the needle 22.
L'enveloppe compressible est formée par un tronçon 86 souple du cathéter d'injection 26 engagé sous le poussoir 54.The compressible envelope is formed by a flexible section 86 of the injection catheter 26 engaged under the pusher 54.
Le cavalier 88 comporte une plaque de support 90 appliquée sur la peau 14, et deux étriers 92 de maintien du tronçon souple 86. La plaque 90 délimite, dirigée vers la peau 14, une surface 94 d'appui sur la peau, et à l'opposé de la surface d'appui 94, une surface supérieure 96 de support du tronçon souple 86. La plaque 90 délimite en outre une encoche 98 de réception de l'aiguille 22 débouchant dans un bord arrière 100 de la plaque 90 situé en regard de la platine d'appui 42. L'encoche 98 comprend un orifice central 102 de section sensiblement circulaire et une fente 104 de dimension transversale inférieure à celle de l'orifice central 102. la fente 104 débouche dans le bord 100, sensiblement dans l'axe de l'âme centrale 30 lorsque l'aiguille 22 est reçue dans l'orifice central 102.The rider 88 comprises a support plate 90 applied to the skin 14, and two stirrups 92 for holding the flexible section 86. The plate 90 delimits, directed towards the skin 14, a surface 94 of support on the skin, and opposite the bearing surface 94, an upper surface 96 for supporting the flexible section 86. The plate 90 further defines a notch 98 for receiving the needle 22 opening into a rear edge 100 of the plate 90 located opposite of the support plate 42. The notch 98 comprises a central orifice 102 of substantially circular section and a slot 104 of smaller transverse dimension than that of the central orifice 102. the slot 104 opens into the edge 100, substantially in the the axis of the central core 30 when the needle 22 is received in the central orifice 102.
Les étriers 92 sont placés de part et d'autre de la plaque 90. Ils font saillie à l'écart de la peau 14 à partir de la surface supérieure 96. Les étriers 92 sont disposés en regard l'un de l'autre et sont espacés le long d'un axe perpendiculaire à l'axe de l'âme 30.The stirrups 92 are placed on either side of the plate 90. They protrude away from the skin 14 from the upper surface 96. The stirrups 92 are arranged opposite one another and are spaced along an axis perpendicular to the axis of the core 30.
Le tronçon souple 86 est engagé à travers les étriers 92 qui le maintiennent en appui sur la surface supérieure 96. Lorsque le mécanisme d'extraction 27 occupe sa position active, et lorsque le tronçon principal 35 de l'aiguille 22 est reçu dans l'encoche 98, le tronçon souple 86 est interposé entre la surface d'activation 76 à l'extrémité ouverte 71 A du poussoir 54 et la surface supérieure 96 du cavalier 88, comme illustré par la Figure 1 .The flexible section 86 is engaged through the stirrups 92 which maintain it bearing on the upper surface 96. When the extraction mechanism 27 occupies its active position, and when the main section 35 of the needle 22 is received in the notch 98, the flexible portion 86 is interposed between the activation surface 76 at the open end 71A of the pusher 54 and the upper surface 96 of the rider 88, as shown in FIG.
Le cavalier 88 est déplaçable par rapport à l'aiguille 22 entre une configuration d'utilisation de l'aiguille 22, dans laquelle l'aiguille 22 est placée à l'écart de l'encoche 98 et une configuration d'extraction, dans laquelle le tronçon principal 35 de l'aiguille 22 a été inséré à travers la fente 104 dans l'orifice 102. Dans la configuration d'extraction, le cavalier 88 est libre de coulisser autour de l'aiguille 22 dans l'orifice 102, le long de l'axe Y-Y'. Le fonctionnement du premier dispositif d'injection 10 selon l'invention va maintenant être décrit.The jumper 88 is movable relative to the needle 22 between a configuration of use of the needle 22, in which the needle 22 is placed away from the notch 98 and an extraction configuration, in which the main section 35 of the needle 22 has been inserted through the slot 104 into the orifice 102. In the extraction configuration, the rider 88 is free to slide around the needle 22 in the orifice 102, the along the Y-Y 'axis. The operation of the first injection device 10 according to the invention will now be described.
Initialement, le mécanisme d'extraction 27 est placé dans sa position inactive avec le poussoir 54 s'étendant généralement perpendiculairement au tronçon principal 35 de l'aiguille 22, en étant plaqué suivant la longueur de l'âme centrale 30. Dans cette position, les flancs 60 de l'embase 52 s'appliquent sur la platine 42.Initially, the extraction mechanism 27 is placed in its inactive position with the pusher 54 extending generally perpendicular to the main section 35 of the needle 22, being pressed along the length of the central core 30. In this position, the flanks 60 of the base 52 apply to the plate 42.
Le poussoir 54 est alors dans sa position d'utilisation de l'aiguille de sorte que la tête 30 est visible.The pusher 54 is then in its position of use of the needle so that the head 30 is visible.
Le cavalier 88 est maintenu dans sa configuration d'utilisation de l'aiguille, à l'écart de l'aiguille 22.The jumper 88 is maintained in its configuration of use of the needle, away from the needle 22.
Dans cette position, l'aiguille 22 du dispositif d'injection 10 est introduite dans une chambre implantable 12 et est enfoncée jusqu'à ce que la platine 42 prenne appui sur la peau du patient. La présence du mécanisme d'extraction 27 replié suivant la longueur de l'âme centrale du support d'aiguille n'est alors pas gênante pour la manipula- tion. De plus, le poussoir 54 étant rabattu suivant l'âme centrale, celui-ci ne fait pas saillie suivant toute sa longueur par rapport à la peau 14 du patient, de sorte que le dispositif d'injection 10, après mise en place, peut être facilement maintenu par un ruban adhésif.In this position, the needle 22 of the injection device 10 is inserted into an implantable chamber 12 and is depressed until the plate 42 bears on the skin of the patient. The presence of the extraction mechanism 27 folded along the length of the central core of the needle holder is not a problem for handling. In addition, the pusher 54 being folded along the central core, it does not protrude along its entire length relative to the skin 14 of the patient, so that the injection device 10, after placement, can be easily held by tape.
Pour le retrait du dispositif d'injection 10, le cavalier 88 est déplacé de sa confi- guration d'utilisation à sa configuration d'extraction. A cet effet, le praticien enroule le cathéter 26 autour du support d'aiguille 24 pour amener le tronçon souple 86 et le cavalier 88 à l'avant de l'âme 30 en regard de la tête 32.For the withdrawal of the injection device 10, the jumper 88 is moved from its configuration of use to its extraction configuration. For this purpose, the practitioner winds the catheter 26 around the needle support 24 to bring the flexible section 86 and the rider 88 to the front of the core 30 opposite the head 32.
Puis, le tronçon principal 35 de l'aiguille 22 est introduit dans l'encoche 98 à travers la fente 104 en déplaçant le cavalier 88 vers la platine d'appui 42 du support d'aiguille 24. La surface inférieure d'appui 96 du cavalier 88 est alors disposée au contact de la peau 14, comme illustré par la Figure 1.Then, the main section 35 of the needle 22 is introduced into the notch 98 through the slot 104 by moving the rider 88 towards the support plate 42 of the needle holder 24. The lower bearing surface 96 of the jumper 88 is then placed in contact with the skin 14, as illustrated in FIG.
Ensuite, le mécanisme d'extraction 27 est redressé en étant amené dans sa position active. Pour ce faire, l'embase 52 et le poussoir 54 sont basculés autour de l'axe X-X' pour être amenés dans la position illustrée sur les Figures 2 et 3. Le poussoir 54 est alors placé dans l'axe Y-Y' du tronçon principal 35 de l'aiguille, et les deux prolongements 64 s'étendent généralement perpendiculairement à l'axe Y-Y'. La tête 32 du support est reçue dans le poussoir évidé 54.Then, the extraction mechanism 27 is straightened by being brought into its active position. To do this, the base 52 and the pusher 54 are tilted about the axis XX 'to be brought into the position shown in Figures 2 and 3. The pusher 54 is then placed in the axis YY' of the main section 35 of the needle, and the two extensions 64 extend generally perpendicular to the Y-Y 'axis. The head 32 of the support is received in the recessed pusher 54.
Par ailleurs, le mécanisme d'extraction 27 s'étend au-dessus du cavalier 88 et du tronçon souple 86, qu'il couvre partiellement. Ainsi, le manchon 56 est placé entre les étriers 92 et repose partiellement en appui sur le tronçon souple 86. La surface d'activation 76 du poussoir 54 est placée en appui sur le tronçon souple 86, sans le comprimer, ou en le comprimant légèrement. Le tronçon souple 86 est ainsi interposé entre deux surfaces 76, 96 du mécanisme d'extraction, sensiblement perpendiculaires à l'axe Y-Y' d'application de la force de maintien, au contact de ces surfaces 76, 96.Moreover, the extraction mechanism 27 extends over the jumper 88 and the flexible section 86, which it partially covers. Thus, the sleeve 56 is placed between the stirrups 92 and rests partially in abutment on the flexible section 86. The activation surface 76 of the pusher 54 is placed in abutment on the flexible section 86, without compressing it, or by compressing it slightly. The flexible section 86 is thus interposed between two surfaces 76, 96 of the extraction mechanism, substantially perpendicular to the axis YY 'of application of the holding force, in contact with these surfaces 76, 96.
Un empilement mécanique continu est ainsi réalisé suivant l'axe Y-Y', entre la surface d'appui 94 sur la peau 14, située sous le cavalier 88 et la surface de contact 78 avec les doigts du praticien, située sur l'appui-doigt 72, par l'intermédiaire successivement de la plaque 90, du tronçon souple 86 et de la tige 70. Cet empilement forme une chaîne de transmission de force depuis la surface de contact 78 vers la surface d'appui 94.A continuous mechanical stack is thus produced along the Y-Y 'axis, between the bearing surface 94 on the skin 14, located under the rider 88 and the contact surface 78 with the practitioner's fingers, located on the support 72, via successively the plate 90, the flexible section 86 and the rod 70. This stack forms a force transmission chain from the contact surface 78 to the bearing surface 94.
Dans cette configuration, et avant tout déplacement de l'aiguille 22 à l'écart de la chambre 12, les moyens de génération 28 sont inactifs, et du fluide est apte à circuler librement à travers le tronçon souple qui présente une section intérieure sensiblement maximale.In this configuration, and before any movement of the needle 22 away from the chamber 12, the generating means 28 are inactive, and fluid is able to flow freely through the flexible section which has a substantially maximum inner section .
Ensuite, le praticien obture le cathéter 26 en activant la pince située en amont du tronçon souple 86. Il applique alors deux doigts de part et d'autre de l'embase 52 sous les appuie-doigt 64 et applique un autre doigt, par exemple son pouce, sur la surface de contact 78. Puis, il exerce sur la surface 78 une force de maintien d'axe Y-Y' dirigée vers la peau 14 pour provoquer le déplacement du poussoir 54 vers la peau 14 par rapport à l'embase 52.Then, the practitioner closes the catheter 26 by activating the clamp located upstream of the flexible section 86. It then applies two fingers on either side of the base 52 under the finger-rest 64 and applies another finger, for example its thumb, on the contact surface 78. Then, it exerts on the surface 78 a holding force axis YY 'directed towards the skin 14 to cause the displacement of the pusher 54 towards the skin 14 relative to the base 52 .
Le déplacement du poussoir 54 vers le bas sous l'effet de la force de maintien appliquée sur la surface de contact 78 provoque la compression du tronçon souple 86 par la surface d'activation 76 jusqu'à ce que le tronçon 86 soit écrasé entre la surface d'activation 76 et la surface supérieure 96. La section intérieure du tronçon souple 86 est alors minimale.The displacement of the pusher 54 downward under the effect of the holding force applied to the contact surface 78 causes the compression of the flexible section 86 by the activation surface 76 until the section 86 is crushed between the activation surface 76 and the upper surface 96. The inner section of the flexible section 86 is then minimal.
La force de maintien exercée par le praticien sur la surface de contact 78 est transmise à la surface d'appui 94 par empilement mécanique, ce qui maintient la sur- face d'appui 94 appliquée contre la peau 14 lors de l'extraction de l'aiguille.The holding force exerted by the practitioner on the contact surface 78 is transmitted to the bearing surface 94 by mechanical stacking, which maintains the bearing surface 94 applied against the skin 14 during the extraction of the 'needle.
En outre, l'écrasement du tronçon souple 86 entre deux surfaces 76, 96 sensiblement perpendiculaires à l'axe Y-Y' d'extraction engendre une surpression dans le passage d'injection de l'aiguille 22, qui se transmet jusqu'à la chambre 16 et dans le conduit 20, pour compenser le reflux de liquide biologique dans le tuyau 20. Le volume de liquide déplacé vers la chambre lors de la compression du tronçon souple est ainsi supérieur au volume normalement aspiré lors du retrait, par exemple supérieur à 7μl et de préférence supérieur à 17μl.In addition, the crushing of the flexible section 86 between two surfaces 76, 96 substantially perpendicular to the axis YY 'extraction generates an overpressure in the injection passage of the needle 22, which is transmitted to the chamber 16 and in the conduit 20, to compensate the reflux of biological fluid in the pipe 20. The volume of liquid displaced to the chamber during compression of the flexible section is thus greater than the volume normally aspirated during the withdrawal, for example greater than 7 .mu.l and preferably greater than 17 .mu.l.
Le tronçon souple 86 est comprimé exclusivement sous l'effet de l'application de la force de maintien, lorsque la surface de contact 96 est placée au contact du corps 14. En l'absence de contact entre la surface de contact 96 et le corps 14, et en l'absence d'application de la force de maintien, le tronçon souple 86 n'est pas comprimé.The flexible section 86 is compressed exclusively under the effect of the application of the holding force, when the contact surface 96 is placed in contact with the body 14. In the absence of contact between the contact surface 96 and the body 14, and in the absence of application of the holding force, the flexible section 86 is not compressed.
Simultanément, l'opérateur tire l'embase 52 à l'écart de la peau 14 le long du poussoir 54. Le déplacement du manchon 56 de l'embase provoque celui du support d'aiguille 24 depuis sa position d'utilisation de l'aiguille, dans laquelle l'aiguille 22 fait saillie hors du tube 70 et du volume intérieur 73 au-delà de l'extrémité avant 71A, vers la position d'extraction de l'aiguille. L'aiguille 22 est progressivement avalée dans le volume intérieur 73, comme illustré par la position intermédiaire représentée sur la Figure 4.Simultaneously, the operator pulls the base 52 away from the skin 14 along the pusher 54. The displacement of the sleeve 56 of the base causes that of the needle holder 24 from its position of use of the needle, in which the needle 22 projects out of the tube 70 and the inner volume 73 beyond the front end 71A, towards the extraction position of the needle. The needle 22 is gradually swallowed in the internal volume 73, as illustrated by the intermediate position shown in FIG. 4.
Lors de ce déplacement, le praticien exerce en permanence contre la peau 14, une force de maintien d'axe Y-Y' dirigée vers la peau 14 par l'intermédiaire du poussoir 54 et du cavalier 88. Cette force évite à la chambre 12 de remonter vers le haut et limite ainsi la douleur ressentie par le patient lors de l'extraction.During this movement, the practitioner permanently exerts against the skin 14, a holding force axis YY 'directed towards the skin 14 via the pusher 54 and the rider 88. This force prevents the chamber 12 to go up upwards and thus limits the pain felt by the patient during extraction.
Dans la position d'extraction, l'aiguille 22 a été totalement avalée à l'intérieur du poussoir 54. Le tronçon principal 35 de l'aiguille s'étend ainsi totalement dans le volume intérieur 73 du poussoir 54 et est protégé, notamment au niveau de sa pointe 29, ce qui évite tout risque de piqûre accidentelle du praticien.In the extraction position, the needle 22 has been totally swallowed inside the pusher 54. The main section 35 of the needle thus extends completely into the internal volume 73 of the pusher 54 and is protected, particularly at level of its tip 29, which avoids any risk of accidental prick of the practitioner.
Le deuxième dispositif 1 10 selon l'invention représenté sur la Figure 5 diffère du premier dispositif 10 en ce que le tronçon souple 86 est fixé en appui sur l'appui-doigt 72. Le tronçon souple 86 et l'appui-doigt 72 forment donc chacun une partie de la surface de contact 78 avec le doigt de l'opérateur. En outre, la surface d'appui sur la peau 14 est formée par la surface annulaire inférieure 76 du poussoir 54.The second device 1 10 according to the invention shown in Figure 5 differs from the first device 10 in that the flexible section 86 is fixed in abutment on the finger rest 72. The flexible section 86 and the finger rest 72 form therefore each a part of the contact surface 78 with the finger of the operator. In addition, the bearing surface on the skin 14 is formed by the lower annular surface 76 of the pusher 54.
Dans le deuxième dispositif 110 selon l'invention, comme dans le premier dispositif 10, un empilement mécanique est réalisé entre la surface de contact 78 et la sur- face d'appui 76 sur la peau 14 par l'intermédiaire du tronçon souple 86, de l'appui-doigt 72, et du poussoir 54.In the second device 110 according to the invention, as in the first device 10, a mechanical stack is produced between the contact surface 78 and the bearing surface 76 on the skin 14 via the flexible section 86, of the finger support 72, and the pusher 54.
La surpression dans le passage d'injection est engendrée lorsque le doigt de l'opérateur exerce la force de maintien, par écrasement du tronçon souple 86 entre son doigt et la surface supérieure 78. En variante, une molette ou un piston est disposé sur l'appui-doigt 72 afin de couvrir le tronçon souple en regard de la surface supérieure 78. Le tronçon souple 86 est ainsi interposé entre la molette ou le piston et la surface supérieure 78, pour être comprimé par déplacement de la molette ou du piston vers la surface supérieure 78 lors de l'application de la force de maintien suivant l'axe Y-Y'.The overpressure in the injection passage is generated when the operator's finger exerts the holding force, by crushing the flexible section 86 between his finger and the upper surface 78. In a variant, a wheel or a piston is arranged on the finger rest 72 in order to cover the flexible section facing the upper surface 78. The flexible section 86 is thus interposed between the wheel or the piston and the upper surface 78, to be compressed by displacement of the wheel or the piston towards the upper surface 78 during the application of the holding force along the axis YY '.
Un troisième dispositif 140 selon l'invention est représenté sur les Figures 6 et 7. Ce troisième dispositif 140 diffère du premier dispositif 10 par la nature du mécanisme d'extraction 27.A third device 140 according to the invention is shown in FIGS. 6 and 7. This third device 140 differs from the first device 10 by the nature of the extraction mechanism 27.
Ainsi, le mécanisme d'extraction 27 comprend une embase inférieure 142 et une tringlerie déployable 144 de protection raccordant l'embase 142 au support 24.Thus, the extraction mechanism 27 comprises a lower base 142 and a deployable linkage 144 of protection connecting the base 142 to the support 24.
L'embase 142 délimite une surface inférieure 146 sensiblement plane, une surface supérieure 148, et une lumière 150 raccordant la surface inférieure 146 à la surface supérieure 148 pour le passage du tronçon principal 35 de l'aiguille 22. La surface supérieure 148 s'étend en regard du support 24. La tringlerie de protection 144 comprend, de part et d'autre du support 24, deux paires de panneaux 150A, 150B. Les panneaux 150A, 150B de chaque paire sont articulés entre eux par une charnière horizontale 152. Les panneaux 150A, 150B sont également articulés par des charnières horizontales respectivement sur le support 24 et sur l'embase 142. Les panneaux 150A, 150B forment avec le support 24 et l'embase 142 un profilé de section verticale en forme de losange 154, déployable entre une position allongée sensiblement parallèle à la peau 14, pour l'utilisation de l'aiguille (Figure 6), et une position allongée perpendiculaire à la peau 14, pour l'extraction de l'aiguille (Figure 7).The base 142 delimits a substantially flat lower surface 146, an upper surface 148, and a slot 150 connecting the lower surface 146 to the upper surface 148 for the passage of the main section 35 of the needle 22. The upper surface 148 is extends across the support 24. The protection linkage 144 comprises, on either side of the support 24, two pairs of panels 150A, 150B. The panels 150A, 150B of each pair are hinged together by a horizontal hinge 152. The panels 150A, 150B are also articulated by horizontal hinges respectively on the support 24 and on the base 142. The panels 150A, 150B form with the support 24 and the base 142 a section of vertical section diamond-shaped 154, deployable between an elongate position substantially parallel to the skin 14, for the use of the needle (Figure 6), and an elongated position perpendicular to the skin 14, for the extraction of the needle (Figure 7).
Dans la position d'utilisation de l'aiguille, la distance qui sépare les charnières 152 de part et d'autre du support 24 et de l'embase 142 est maximale, alors que dans la position d'extraction, cette distance est minimale.In the position of use of the needle, the distance between the hinges 152 on either side of the support 24 and the base 142 is maximum, while in the extraction position, this distance is minimal.
Le profilé de section losange 154 délimite un volume intérieur 156 de protection d'aiguille. Dans la position d'utilisation, le tronçon principal 35 de l'aiguille 22 fait saillie à travers l'ouverture 149 hors du volume intérieur 156. Dans la position d'extraction, le tronçon principal 35 et la pointe 29 sont totalement reçus dans le volume intérieur 156 entre le support 24 et l'embase 142.The rhombic section section 154 defines an interior needle protection volume 156. In the position of use, the main section 35 of the needle 22 projects through the opening 149 out of the internal volume 156. In the extraction position, the main section 35 and the tip 29 are completely received in the internal volume 156 between the support 24 and the base 142.
Les charnières 152 définissent par ailleurs des surfaces de contact avec les doigts de l'opérateur.The hinges 152 also define contact surfaces with the fingers of the operator.
Les moyens 28 de génération d'une surpression comprennent un tronçon souple 86 du cathéter 26 fixé sous la surface inférieure 146, pour être interposé entre cette surface 146 et la peau 14. Le tronçon souple 86 est placé au contact de la peau 14. Il délimite ainsi partiellement, avec la surface inférieure 146, la surface d'appui sur la peau 14.The means 28 for generating an overpressure comprise a flexible section 86 of the catheter 26 fixed under the lower surface 146, to be interposed between this surface 146 and the skin 14. The flexible section 86 is placed in contact with the skin 14. It thus partially defines, with the lower surface 146, the bearing surface on the skin 14.
Pour injecter du liquide dans le patient, l'aiguille 22 est plantée à travers la peau 14, en maintenant le mécanisme 27 dans sa position d'utilisation de l'aiguille. Dans cette position, le tronçon souple 86 est maintenu, avec une section intérieure maximale, entre la surface inférieure 146 et la peau 14.To inject liquid into the patient, the needle 22 is planted through the skin 14, keeping the mechanism 27 in its position of use of the needle. In this position, the flexible section 86 is maintained, with a maximum inner section, between the lower surface 146 and the skin 14.
Puis, lors de l'extraction, l'opérateur saisit des surfaces de contact sur les charnières 152. Il applique alors une force de maintien dirigée vers la peau 14 pour exercer un appui sur la peau 14. Cette force de maintien provoque la compression du tronçon souple 86 entre la peau 14 et la surface 146, et la génération d'une surpression dans l'aiguille 22 puis dans la chambre 16.Then, during extraction, the operator grasps contact surfaces on the hinges 152. He then applies a holding force directed towards the skin 14 to exert a bearing on the skin 14. This holding force causes the compression of the flexible portion 86 between the skin 14 and the surface 146, and the generation of an overpressure in the needle 22 and in the chamber 16.
Ensuite, l'opérateur rapproche les charnières 152, ce qui éloigne progressivement le support 24 à l'écart de l'embase 142 à l'opposé de la peau 14. Lors de ce dé- placement, l'aiguille 22 est avalée progressivement à travers l'ouverture 149 dans le volume intérieur 156 jusqu'à la position d'extraction représentée sur la Figure 7, dans laquelle elle est reçue totalement dans le volume intérieur 156. Then, the operator brings the hinges 152 closer together, which progressively moves the support 24 away from the base 142 away from the skin 14. During this displacement, the needle 22 is swallowed progressively at through the opening 149 in the interior volume 156 to the extraction position shown in FIG. 7, in which it is totally received in the interior volume 156.

Claims

REVENDICATIONS
1 .- Dispositif d'injection (10 ; 1 10 ; 140) d'un liquide dans un corps (14), notamment le corps d'un patient, du type comprenant : - un support d'aiguille (24) portant une aiguille d'injection (22) destinée à être piquée dans le corps (14), l'aiguille d'injection (22) délimitant un passage d'injection ;1 .- Injection device (10; 1 10; 140) of a liquid in a body (14), in particular the body of a patient, of the type comprising: - a needle support (24) carrying a needle injection needle (22) to be stitched into the body (14), the injection needle (22) defining an injection passage;
- un ensemble (27) d'extraction de l'aiguille (22) comprenant une armature (54 ; 144) de protection d'aiguille délimitant un volume intérieur (73 ; 156); le support d'aiguille (24) étant déplaçable par rapport à l'armature de protection (54 ; 144) lors de l'extraction de l'aiguille (22) entre une position d'utilisation, dans laquelle l'aiguille (22) fait saillie hors du volume intérieur (73 ; 156) et une position d'extraction, dans laquelle l'aiguille (22) est reçue dans le volume intérieur (73 ; 156); l'ensemble d'extraction (27) présentant une surface (94) d'appui sur le corps (14), et une surface (72 ; 152) de contact apte à entrer en contact avec au moins un doigt d'un opérateur pour exercer une force de maintien de la surface d'appui (94) contre le corps (14), la force de maintien étant dirigée vers le corps (14) lors du déplacement relatif du support d'aiguille (24) par rapport à l'armature de protection (54 ; 144) entre la position d'utilisation et la position d'extraction ; le dispositif (10 ; 110 ; 140) comprenant en outre : - une enveloppe (28) compressible de génération d'une surpression dans le passage d'injection ; caractérisé en ce que l'enveloppe compressible (28) est empilée mécaniquement entre la surface de contact (72 ; 152) et la surface d'appui (94), pour être comprimée par l'application, sur la surface de contact (72 ; 152), de ladite force de maintien lorsque la surface d'appui (94) est en contact avec le corps (14), pendant le déplacement relatif du support d'aiguille (24) par rapport à l'armature de protection (54 ; 144).- an assembly (27) for extracting the needle (22) comprising a needle protection armature (54; 144) defining an interior volume (73; 156); the needle holder (24) being displaceable relative to the protective armature (54; 144) during the extraction of the needle (22) between a position of use, wherein the needle (22) protrudes out of the inner volume (73; 156) and an extraction position, in which the needle (22) is received in the inner volume (73; 156); the extraction assembly (27) having a bearing surface (94) on the body (14), and a contact surface (72; 152) adapted to contact at least one finger of an operator for exerting a force for holding the bearing surface (94) against the body (14), the holding force being directed towards the body (14) during the relative movement of the needle holder (24) relative to the protective armature (54; 144) between the use position and the extraction position; the device (10; 110; 140) further comprising: - a compressible envelope (28) for generating an overpressure in the injection passage; characterized in that the compressible envelope (28) is mechanically stacked between the contact surface (72; 152) and the bearing surface (94) to be compressed by the application on the contact surface (72; 152), of said holding force when the bearing surface (94) is in contact with the body (14), during the relative movement of the needle holder (24) with respect to the protective armature (54; 144).
2.- Dispositif (10 ; 140) selon la revendication 1 , caractérisé en ce que l'ensemble d'extraction (27) présente une surface inférieure (76 ; 146) d'activation de la surpression, destinée à être dirigée vers le corps (14), l'enveloppe compressible (28) faisant saillie vers le corps (14) à partir de la surface d'activation (76 ; 146) lors de l'extraction de l'aiguille (22), l'application de la force de maintien étant apte à provoquer la compression de l'enveloppe compressible (28) entre la surface inférieure (76) et une surface additionnelle (96 ; 14) sensiblement parallèle à la surface inférieure (76).2.- Device (10; 140) according to claim 1, characterized in that the extraction assembly (27) has a lower surface (76; 146) of activation of the pressure, intended to be directed towards the body (14), the compressible envelope (28) protruding towards the body (14) from the activation surface (76; 146) during the extraction of the needle (22), the application of the holding force being able to compress the compressible envelope (28) between the lower surface (76) and an additional surface (96; 14) substantially parallel to the lower surface (76).
3.- Dispositif (10) selon la revendication 2, caractérisé en ce que l'ensemble comprend une plaque d'appui (90), solidaire de l'enveloppe compressible (28) et desti- née à être appliquée contre le corps (14), l'enveloppe compressible (28) étant comprimée entre la surface d'activation (76) et la plaque d'appui (90) lors de l'application de la force de maintien.3.- Device (10) according to claim 2, characterized in that the assembly comprises a support plate (90) integral with the compressible envelope (28) and it is pressed against the body (14), the compressible envelope (28) being compressed between the activation surface (76) and the support plate (90) during the application of the holding force.
4.- Dispositif (140) selon la revendication 2, caractérisé en ce que l'enveloppe compressible (28) délimite une partie de la surface d'appui, l'enveloppe compressible (28) étant comprimée entre la surface d'activation (146) et le corps (14) lors de l'application de la force de maintien.4.- Device (140) according to claim 2, characterized in that the compressible envelope (28) defines a portion of the bearing surface, the compressible envelope (28) being compressed between the activation surface (146). ) and the body (14) during the application of the holding force.
5.- Dispositif (120) selon la revendication 1 , caractérisé en ce que l'enveloppe compressible (28) fait saillie à l'écart du corps (14) par rapport à une surface supérieure (78) de l'ensemble d'extraction, la surface de contact étant délimitée au moins partiellement par l'enveloppe compressible (28) pour être comprimée entre le doigt d'un opérateur et la surface supérieure (78) lors de l'application de la force de maintien.5.- Device (120) according to claim 1, characterized in that the compressible envelope (28) protrudes away from the body (14) relative to an upper surface (78) of the extraction assembly , the contact surface being at least partially delimited by the compressible envelope (28) to be compressed between the finger of an operator and the upper surface (78) during the application of the holding force.
6.- Dispositif (10 ; 120 ; 140) selon l'une quelconque des revendications précédentes, caractérisé en ce qu'il comporte un cathéter d'injection (26) raccordé à une ex- trémité sur le support d'aiguille (24) et débouchant dans le passage d'injection de l'aiguille (22), l'enveloppe compressible (28) étant formée par un tronçon souple (86) du cathéter d'injection (26).6. Device (10; 120; 140) according to any one of the preceding claims, characterized in that it comprises an injection catheter (26) connected at one end to the needle support (24) and opening into the injection passage of the needle (22), the compressible envelope (28) being formed by a flexible section (86) of the injection catheter (26).
7.- Dispositif (10) selon l'une quelconque des revendications précédentes, caractérisé en ce que l'armature de protection (54) est déplaçable par rapport au support d'aiguille (24) suivant un axe (Y-Y') d'extraction, l'aiguille d'injection (22) présentant un tronçon principal (35) qui fait saillie par rapport au support d'aiguille (24) suivant l'axe d'extraction (Y-Y'), et en ce que l'enveloppe compressible (28) est montée déplaçable à coulissement le long du tronçon principal (22) suivant l'axe d'extraction (Y-Y') par l'intermédiaire d'une attache coulissante (88). 7.- Device (10) according to any one of the preceding claims, characterized in that the protective armature (54) is movable relative to the needle holder (24) along an axis (Y-Y ') d extraction, the injection needle (22) having a main section (35) projecting from the needle support (24) along the extraction axis (Y-Y '), and in that the compressible envelope (28) is slidably movable along the main section (22) along the extraction axis (Y-Y ') via a sliding fastener (88).
8.- Dispositif (10 ; 120) selon l'une quelconque des revendications précédentes, caractérisé en ce que l'ensemble d'extraction (27) comprend une embase (52) montée sur le support d'aiguille (24) et un poussoir (54) monté coulissant dans l'embase (52), le poussoir (54) délimitant au moins partiellement la surface de contact (72) et délimitant le volume intérieur. 8.- Device (10; 120) according to any one of the preceding claims, characterized in that the extraction assembly (27) comprises a base (52) mounted on the needle support (24) and a pusher (54) slidably mounted in the base (52), the pusher (54) at least partially defining the contact surface (72) and defining the interior volume.
9.- Dispositif (140) selon l'une quelconque des revendications 1 à 5, caractérisé en ce que l'ensemble d'extraction (27) comprend une base (142) destinée à être placée en regard du corps (14), l'armature comprenant une tringlerie (144) déployable à l'écart du corps à partir de la base (142) entre une configuration repliée sur la base (142) au voisinage du corps (14) et une configuration déployée à l'écart de la base (142) à l'écart du corps (14), la tringlerie (144) raccordant le support d'aiguille (24) à la base (142). 9.- Device (140) according to any one of claims 1 to 5, characterized in that the extraction assembly (27) comprises a base (142) intended to be placed opposite the body (14), l frame comprising a linkage (144) deployable away from the body from the base (142) between a folded configuration on the base (142) in the vicinity of the body (14) and a deployed configuration away from the base (142) away from the body (14), the linkage (144) connecting the needle holder (24) to the base (142).
10.- Dispositif (140) selon la revendication 7, caractérisé en ce que l'enveloppe compressible (28) est fixée sous la base (142).10.- Device (140) according to claim 7, characterized in that the compressible envelope (28) is fixed under the base (142).
1 1.- Dispositif selon l'une quelconque des revendications précédentes, caractérisé en ce que l'enveloppe compressible est propre à être comprimée exclusivement sous l'effet de l'application de la force de maintien lorsque la surface de contact est placée au contact du corps, l'enveloppe compressible n'étant pas comprimée en l'absence de contact entre la surface de contact et le corps et en l'absence d'application de la force de maintien. 1 1.- Device according to any one of the preceding claims, characterized in that the compressible envelope is adapted to be compressed exclusively under the effect of the application of the holding force when the contact surface is placed in contact of the body, the compressible envelope being uncompressed in the absence of contact between the contact surface and the body and in the absence of application of the holding force.
PCT/FR2008/050990 2007-06-07 2008-06-04 Device for injecting a liquid into a body WO2009004205A2 (en)

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FR0755560A FR2916979B1 (en) 2007-06-07 2007-06-07 DEVICE FOR INJECTING A LIQUID INTO A BODY.
FR0755560 2007-06-07

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WO2009004205A3 WO2009004205A3 (en) 2009-03-19

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CN114870157A (en) * 2022-05-25 2022-08-09 南方医科大学南方医院 Infusion device and method of use

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FR3129841B1 (en) * 2021-12-03 2024-03-01 Design 33 Safety Medical Needle Set

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FR2886857A1 (en) * 2005-06-08 2006-12-15 Perouse Soc Par Actions Simpli Device for injecting medicinal solution into patient, has lateral flaps articulated on needle holder and means for generating overpressure in injection pipe during needle extraction

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EP1125596A2 (en) * 2000-02-16 2001-08-22 Terumo Kabushiki Kaisha Intravascular catheter
WO2002068015A2 (en) * 2001-02-22 2002-09-06 Insulet Corporation Modular infusion device and method
US20050049553A1 (en) * 2003-08-27 2005-03-03 Triplett Daniel J. Safety needle with positive flush
FR2886857A1 (en) * 2005-06-08 2006-12-15 Perouse Soc Par Actions Simpli Device for injecting medicinal solution into patient, has lateral flaps articulated on needle holder and means for generating overpressure in injection pipe during needle extraction

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2010010307A2 (en) * 2008-07-23 2010-01-28 Laboratoires Perouse Device for injecting a liquid into a body, such as that of a patient
FR2934163A1 (en) * 2008-07-23 2010-01-29 Perouse Lab DEVICE FOR INJECTING A LIQUID INTO A BODY, IN PARTICULAR THE BODY OF A PATIENT.
WO2010010307A3 (en) * 2008-07-23 2010-03-25 Laboratoires Perouse Device for injecting a liquid into a body of a patient
US8262615B2 (en) 2008-07-23 2012-09-11 Laboratories Perouse Device for injecting a liquid into a body of a patient
CN114870157A (en) * 2022-05-25 2022-08-09 南方医科大学南方医院 Infusion device and method of use
CN114870157B (en) * 2022-05-25 2023-05-26 南方医科大学南方医院 Infusion device and use method

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FR2916979B1 (en) 2010-10-22
WO2009004205A3 (en) 2009-03-19

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