FR2752164A1 - Needle to puncture skin e.g. for implanting a chamber under the skin - Google Patents

Needle to puncture skin e.g. for implanting a chamber under the skin Download PDF

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Publication number
FR2752164A1
FR2752164A1 FR9610054A FR9610054A FR2752164A1 FR 2752164 A1 FR2752164 A1 FR 2752164A1 FR 9610054 A FR9610054 A FR 9610054A FR 9610054 A FR9610054 A FR 9610054A FR 2752164 A1 FR2752164 A1 FR 2752164A1
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France
Prior art keywords
needle
pusher
housing
puncture
face
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Granted
Application number
FR9610054A
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French (fr)
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FR2752164B1 (en
Inventor
Daniel Rossi
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Vygon SA
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Vygon SA
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Publication date
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Priority to FR9610054A priority Critical patent/FR2752164B1/en
Publication of FR2752164A1 publication Critical patent/FR2752164A1/en
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Publication of FR2752164B1 publication Critical patent/FR2752164B1/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02—Access sites
    • A61M39/0208—Subcutaneous access sites for injecting or removing fluids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/158—Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/158—Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
    • A61M2005/1581—Right-angle needle-type devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2209/00—Ancillary equipment
    • A61M2209/04—Tools for specific apparatus

Abstract

The needle is joined to a supply tube (2) and pivots in a case (3) between a position to puncture the skin and a retracted position. A push button (7) is moved in one end of the case, by the index finger, and moves the needle. The needle is fixed to a shaft that pivots in the case. The shaft has two cams (5) and one cam is moved by the button to turn the shaft and move the needle out of the case. The other cam is moved when the button is released and retracts the needle.

Description

L'invention concerne un dispositif à aiguille pour ponctionner une zone corporelle, cette aiguille étant reliée ou à relier à un tube d'alimentation, notamment pour permettre l'alimentation d'une chambre implantée sous la peau. The invention relates to a needle device for puncturing a body area, this needle being connected or to be connected to a feeding tube, in particular for allowing the feeding of a chamber implanted under the skin.

Les cathéters à chambre implantable sont perfusés en utilisant traditionnellement une aiguille de type épicrânienne courbée à 90". Lors de la ponction, l'aiguille traverse la peau du patient, puis le septum de la chambre implantable et débouche dans la chambre qui est reliée au cathéter. Catheters with an implantable chamber are traditionally perfused using a 90 "bent epicranial type needle. During the puncture, the needle passes through the patient's skin, then the septum of the implantable chamber and opens into the chamber which is connected to the catheter.

Après l'arrêt de la perfusion, cette aiguille est retirée. Elle peut avoir été contaminée du fait de la traversée de la peau du patient ou du contact avec le fluide présent dans la chambre. After stopping the infusion, this needle is withdrawn. It may have been contaminated due to the passage of the patient's skin or contact with the fluid present in the chamber.

Cette aiguille n'étant pas protégée devient alors un danger potentiel pour le personnel soignant et pour les personnes manipulant ce type de déchet hospitalier qui peuvent être contaminés à leur tour. This unprotected needle then becomes a potential danger for nursing staff and for people handling this type of hospital waste which can in turn be contaminated.

Le but de l'invention est de fournir un dispositif qui présente les avantages suivants
- ménager une position de retrait dans laquelle l'aiguille est protégée et ne risque pas de piquer le personnel
- rendre ce retrait automatique au moment de l'ablation de l'aiguille
- verrouiller l'aiguille en position de sécurité avant utilisation et après retrait.The object of the invention is to provide a device which has the following advantages
- provide a withdrawal position in which the needle is protected and does not risk pricking personnel
- make this automatic withdrawal when the needle is removed
- lock the needle in the safety position before use and after removal.

Ce but est atteint au moyen d'un dispositif à aiguille caractérisé selon l'invention en ce que l'aiguille est montée à pivotement dans un boîtier apte à être tenu entre les doigts d'une main, sans intervention de l'index, l'aiguille pouvant pivoter entre une position sortie (de ponction) où l'aiguille traverse une face du boîtier, perpendiculairement à cette face et une position enfoncée (de sécurité) où l'aiguille est escamotée à l'intérieur du boîtier, ladite face du boîtier étant apte à être posée sur la zone à ponctionner, ledit boîtier présentant une ouverture en bout pour le passage d'un poussoir en saillie qui est déplaçable, au moyen de l'index de la main qui tient le boîtier, vers une position enfoncée lorsque le boîtier est tenu en main et qui est rappelé élastiquement vers sa position relâchée, des moyens de transmission étant prévus entre le poussoir et l'aiguille en sorte que le déplacement du poussoir vers sa position enfoncée provoque le pivotement de l'aiguille en position de ponction, et que le relâchement du poussoir provoque automatiquement le pivotement de l'aiguille vers sa position de sécurité. This object is achieved by means of a needle device characterized according to the invention in that the needle is pivotally mounted in a casing capable of being held between the fingers of one hand, without the intervention of the index finger, l needle can be pivoted between an extended (puncture) position where the needle crosses a face of the housing, perpendicular to this face and a pressed (safety) position where the needle is retracted inside the housing, said face of the housing being able to be placed on the area to be punctured, said housing having an end opening for the passage of a protruding pusher which is movable, by means of the index finger of the hand holding the housing, towards a depressed position when the housing is held in hand and which is resiliently returned to its relaxed position, transmission means being provided between the plunger and the needle so that the movement of the plunger towards its depressed position prov o that the pivoting of the needle in the puncture position, and that the release of the plunger automatically causes the pivoting of the needle towards its safety position.

Dans une variante, les moyens de transmission sont du type pignon/crémaillère,la crémaillère étant solidaire du poussoir et le pignon étant solidaire de l'aiguille. In a variant, the transmission means are of the pinion / rack type, the rack being secured to the pusher and the pinion being secured to the needle.

Le moyen de rappel élastique du poussoir est constitué par une conformation particulière du poussoir ou par un ressort indépendant. The elastic return means of the pusher is constituted by a particular conformation of the pusher or by an independent spring.

Dans une réalisation préférée, lesdits moyens de transmission comprennent un arbre pivotant sur lequel l'aiguille est fixée, cet arbre étant muni de deux cames, les cames et le poussoir étant conformées et disposées pour que l'une des cames soit sollicitée par le poussoir dans sa course d'enfoncement en provoquant le pivotement de l'arbre en sorte que l'aiguille vienne en position sortie, et que l'autre came soit sollicitée par le poussoir dans sa course de rappel en provoquant le pivotement de l'arbre en sorte que l'aiguille vienne en position de sécurité. In a preferred embodiment, said transmission means comprise a pivoting shaft on which the needle is fixed, this shaft being provided with two cams, the cams and the pusher being shaped and arranged so that one of the cams is biased by the pusher in its driving stroke by causing the shaft to pivot so that the needle comes into the extended position, and the other cam is urged by the pusher in its return stroke by causing the shaft to pivot in so that the needle comes into the safety position.

On décrira ci-après un exemple de réalisation d'un dispositif selon l'invention, en référence aux figures du dessin joint selon lequel
- la figure 1 est une perspective schématique, et avec des parties arrachées, du dispositif, le poussoir étant en position enfoncée et l'aiguille étant en position de ponction
- la figure 2 est une perspective de l'aiguille avec son arbre à cames;
- la figure 3 est une coupe verticale du dispositif (abstraction faite du boîtier), le poussoir étant en position relâchée de sécurité
- la figure 4 est une coupe verticale du dispositif (abstraction faite du boîtier), le poussoir étant en position enfoncée de ponction
- la figure 5 est une vue schématique de dessus du dispositif à l'état verrouillé
- la figure 6 est une vue schématique de dessus du dispositif à l'état déverrouillé
- les figures 7A à 7D sont des perspectives du dispositif au cours des phases successives de son utilisation.An embodiment of a device according to the invention will be described below, with reference to the figures in the accompanying drawing, according to which
- Figure 1 is a schematic perspective, and with parts broken away, of the device, the pusher being in the depressed position and the needle being in the puncture position
- Figure 2 is a perspective of the needle with its camshaft;
- Figure 3 is a vertical section of the device (excluding the housing), the pusher being in the released safety position
- Figure 4 is a vertical section of the device (excluding the housing), the pusher being in the depressed puncture position
- Figure 5 is a schematic top view of the device in the locked state
- Figure 6 is a schematic top view of the device in the unlocked state
- Figures 7A to 7D are perspectives of the device during the successive phases of its use.

L'aiguille (1) reliée à une tubulure de perfusion (2), est montée pivotante dans un boîtier (3) grâce à un arbre (4) qui lui est perpendiculaire. The needle (1) connected to an infusion set (2), is pivotally mounted in a housing (3) by means of a shaft (4) which is perpendicular thereto.

Ledit arbre comporte à chaque extrémité une came (5, 6) située dans un plan qui lui est perpendiculaire, les deux cames étant décalées angulairement de 90".  Said shaft has at each end a cam (5, 6) situated in a plane which is perpendicular thereto, the two cams being angularly offset by 90 ".

Un bouton poussoir (7) monté à coulisse dans le boîtier présente deux côtés parallèles (7a, 7b) découpés pour agir respectivement sur l'une et sur l'autre des deux cames (5, 6) de façon à faire pivoter l'aiguille de l'une vers l'autre de deux positions à 90" l'une de l'autre, selon le sens de déplacement du poussoir. A push button (7) mounted to slide in the housing has two parallel sides (7a, 7b) cut to act respectively on one and on the other of the two cams (5, 6) so as to rotate the needle from one to the other of two positions 90 "from each other, according to the direction of movement of the pusher.

En poussant le bouton l'opérateur fait basculer l'aiguille vers la position de ponction grâce à l'action de l'un des côtés sur la came correspondante. Au retour du bouton, le côté opposé agit sur la came opposée et fait remonter l'aiguille en position de sécurité. By pushing the button, the operator switches the needle to the puncture position by the action of one of the sides on the corresponding cam. When the button returns, the opposite side acts on the opposite cam and raises the needle to the safety position.

En position de ponction, l'aiguille traverse la face inférieure 3a du boîtier. In the puncture position, the needle passes through the lower face 3a of the housing.

Une fonction de ressort est associée au mouvement de rotation de l'aiguille, de telle sorte qu'en relâchant le bouton, ladite aiguille remonte d'elle-même en position de sécurité. A spring function is associated with the rotation movement of the needle, so that by releasing the button, said needle rises by itself in the safety position.

Cette fonction est réalisée dans l'exemple décrit par deux lames de ressort (8) solidaires du bouton poussoir et travaillant en flexion lors de la pression dudit bouton, l'extrémité de ladite lame venant en appui sur une face (9) du boîtier (fig 1). This function is performed in the example described by two spring blades (8) integral with the push button and working in flexion when the said button is pressed, the end of said blade coming to bear on one face (9) of the housing ( fig 1).

Le retour en position de sécurité s'effectue donc automatiquement dès que l'on a retiré l'aiguille en saisissant le boîtier sans appuyer sur le bouton poussoir et en le tirant perpendiculairement à la peau du patient. Returning to the safety position therefore takes place automatically as soon as the needle has been withdrawn by grasping the housing without pressing the push button and pulling it perpendicularly to the patient's skin.

Un bouton de sécurité (10) coulissant sur la face supérieure (3b) du boîtier (3) est conçu pour empêcher ou autoriser la rentrée du poussoir en empêchant (figure 5) ou en autorisant (figure 6) la paroi supérieure (7c) du poussoir, convenablement découpée à cet effet, à se déplacer vers la position rentrée du poussoir. A safety button (10) sliding on the upper face (3b) of the housing (3) is designed to prevent or authorize the retraction of the pusher by preventing (FIG. 5) or by authorizing (FIG. 6) the upper wall (7c) of the pusher, suitably cut for this purpose, to move towards the retracted position of the pusher.

Ce verrouillage renforce la sécurité du personnel soignant pendant les manipulations préalables à la ponction, et surtout après la ponction, où le risque de contamination potentielle est beaucoup plus élevé. This locking reinforces the safety of the nursing staff during the manipulations prior to the puncture, and especially after the puncture, where the risk of potential contamination is much higher.

Une plaquette en mousse (11) (figures 7) préalablement découpée dans sa partie centrale pour le passage de l'aiguille est collée à la face inférieure (3a) du boîtier. Un protecteur amovible de type papier siliconé (12) est disposé sur la face apparente adhésive de la plaquette de mousse. Ce protecteur est ôté avant la ponction, et permet au boîtier d'être fixé sur la peau après réalisation de la ponction. A foam plate (11) (Figures 7) previously cut in its central part for the passage of the needle is glued to the underside (3a) of the housing. A removable protector of silicone paper type (12) is arranged on the visible adhesive face of the foam board. This protector is removed before the puncture, and allows the case to be fixed on the skin after performing the puncture.

La découpe effectuée dans la partie centrale de la plaquette permet le débattement de l'aiguille, et maintient l'asepsie de la peau (réalisée par désinfection préalablement à la ponction) en entourant complètement le point de ponction. The cut in the central part of the plate allows the movement of the needle, and maintains the asepsis of the skin (performed by disinfection prior to puncture) by completely surrounding the puncture site.

Sur la figure 7, on a représenté les différentes phases d'une utilisation après enlèvement de la pellicule de protection de la face autocollante
Fig 7A : saisie du dispositif par l'opérateur qui se prépare à pousser le poussoir, après avoir déverrouillé;
Fig 7B: aiguille prête pour la ponction;
Fig 7C : ponction effectuée, par exemple pour alimenter un site (12) implanté sous la peau (13);
Fig 7D : retour automatique de l'aiguille vers la position de sécurité, ainsi que du bouton poussoir en position de repos, sous l'effet des lames élastiques incluses dans le dispositif, dès l'ablation de l'aiguille et le relâchement du poussoir.In FIG. 7, the different phases of use have been represented after removal of the protective film from the adhesive face.
Fig 7A: entry of the device by the operator who is preparing to push the pusher, after having unlocked;
Fig 7B: needle ready for puncture;
Fig 7C: puncture performed, for example to supply a site (12) implanted under the skin (13);
Fig 7D: automatic return of the needle to the safety position, as well as of the push button in the rest position, under the effect of the elastic blades included in the device, as soon as the needle is removed and the plunger is released .

Le dispositif peut alors être reverrouillé en déplaçant le bouton de sécurité. The device can then be relocked by moving the security button.

Il est bien entendu que la réalisation décrite ci-dessus ne constitue qu'un exemple non limitatif de la portée de l'invention et que l'homme du métier peut substituer aux moyens décrits des moyens fonctionnellement équivalents sans sortir du cadre de l'invention.  It is understood that the embodiment described above constitutes only a non-limiting example of the scope of the invention and that the person skilled in the art can replace the means described with functionally equivalent means without departing from the scope of the invention .

Claims (6)

RevendicationsClaims 1. Dispositif comportant une aiguille (1) pour ponctionner une zone corporelle, cette aiguille étant reliée ou à relier à un tube d'alimentation (2), notamment pour alimenter une chambre implantée sous la peau, caractérisé en ce que l'aiguille est montée à pivotement dans un boîtier (3) apte à être tenu entre les doigts d'une main, sans intervention de l'index, l'aiguille pouvant pivoter entre une position sortie (de ponction) où l'aiguille traverse une face (3a) du boîtier, perpendiculairement à cette face et une position rentrée (de sécurité) où l'aiguille est escamotée à l'intérieur du boîtier, ladite face du boîtier étant apte à être posée sur la zone à ponctionner, ledit boîtier présentant une ouverture en bout (3c) pour le passage d'un poussoir (7) en saillie qui est déplaçable, sous la poussée de l'index de la main qui tient le boîtier, vers une position enfoncée (de ponction) et qui est rappelé élastiquement vers sa position relâchée (de sécurité), des moyens de transmission (4, 5, 6) étant prévus entre le poussoir et l'aiguille, en sorte que le déplacement du poussoir vers sa position enfoncée provoque le pivotement de l'aiguille vers sa position sortie (de ponction) et que le déplacement du poussoir vers sa position relâchée provoque automatiquement le pivotement de l'aiguille vers sa position rentrée (de sécurité) dès que l'aiguille est extraite de la zone ponctionnée. 1. Device comprising a needle (1) for puncturing a body area, this needle being connected or to be connected to a supply tube (2), in particular for supplying a chamber implanted under the skin, characterized in that the needle is pivotally mounted in a housing (3) able to be held between the fingers of one hand, without intervention of the index finger, the needle being able to pivot between an extended (puncture) position where the needle crosses a face (3a ) of the housing, perpendicular to this face and a retracted (safety) position where the needle is retracted inside the housing, said face of the housing being able to be placed on the area to be punctured, said housing having an opening in end (3c) for the passage of a protruding pusher (7) which is movable, under the push of the index finger of the hand which holds the casing, towards a depressed (puncture) position and which is resiliently returned towards its relaxed position (from safety), transmission means (4, 5, 6) being provided between the pusher and the needle, so that the displacement of the pusher towards its depressed position causes the pivoting of the needle towards its extended (puncture) position and that the movement of the pusher to its released position automatically causes the needle to pivot to its retracted (safety) position as soon as the needle is extracted from the punctured area. 2. Dispositif selon la revendication 1, dans lequel lesdits moyens de transmission comprennent un arbre (4) monté à pivotement dans le boîtier et sur lequel l'aiguille est fixée, cet arbre étant muni de deux cames (5, 6), les cames et le poussoir étant conformées et disposées pour que l'une des cames (6) soit sollicitée par le poussoir dans sa course d'enfoncement en provoquant le pivotement de l'arbre en sorte que l'aiguille (1) vienne en position sortie (de ponction), et que l'autre came (5) soit sollicitée par le poussoir dans sa course de rappel en provoquant le pivotement de l'arbre en sorte que l'aiguille (1) vienne en position rentrée (de sécurité).  2. Device according to claim 1, wherein said transmission means comprise a shaft (4) pivotally mounted in the housing and on which the needle is fixed, this shaft being provided with two cams (5, 6), the cams and the pusher being shaped and arranged so that one of the cams (6) is urged by the pusher in its driving stroke by causing the shaft to pivot so that the needle (1) comes into the extended position ( puncture), and that the other cam (5) is urged by the pusher in its return stroke by causing the shaft to pivot so that the needle (1) comes into the retracted (safety) position. 3. Dispositif selon la revendication 1, dans lequel les moyens de transmission sont du type pignon/crémaillère, la crémaillère étant solidaire du poussoir et le pignon étant solidaire de l'aiguille. 3. Device according to claim 1, wherein the transmission means are of the pinion / rack type, the rack being secured to the pusher and the pinion being secured to the needle. 4. Dispositif selon l'une des revendications 1 ou 3, dans lequel le poussoir comporte des lames élastiques (8) qui prennent appui sur une paroi du boîtier pour rappeler le poussoir en position de sortie. 4. Device according to one of claims 1 or 3, wherein the pusher comprises elastic blades (8) which bear on a wall of the housing to return the pusher to the exit position. 5. Dispositif selon l'une des revendications 1 à 4, dans lequel un bouton de verrouillage (10) est monté sur le boîtier pour bloquer l'aiguille en position sortie ou la libérer. 5. Device according to one of claims 1 to 4, wherein a locking button (10) is mounted on the housing to lock the needle in the extended position or release it. 6. Dispositif selon l'une des revendications 1 à 5, dans lequel le boîtier est muni sur sa face de pose (3a) d'une plaquette (11) en mousse qui est découpée pour laisser passer l'aiguille et qui présente la face apparente adhésive provisoirement protégée.  6. Device according to one of claims 1 to 5, in which the housing is provided on its laying face (3a) with a foam plate (11) which is cut to let the needle pass and which has the face apparent adhesive temporarily protected.
FR9610054A 1996-08-09 1996-08-09 DEVICE FOR PERFORMING A PUNCTURE THROUGH THE SKIN BY MEANS OF A NEEDLE Expired - Fee Related FR2752164B1 (en)

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FR9610054A FR2752164B1 (en) 1996-08-09 1996-08-09 DEVICE FOR PERFORMING A PUNCTURE THROUGH THE SKIN BY MEANS OF A NEEDLE

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FR9610054A FR2752164B1 (en) 1996-08-09 1996-08-09 DEVICE FOR PERFORMING A PUNCTURE THROUGH THE SKIN BY MEANS OF A NEEDLE

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Cited By (36)

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EP1329233A1 (en) * 2001-12-28 2003-07-23 CANE' S.r.l. Container for disposable needle
EP1438091A2 (en) * 2001-10-04 2004-07-21 Smiths Medical MD, Inc. Right angle safety needle
WO2005092411A1 (en) * 2004-03-26 2005-10-06 Unomedical A/S Injector device for infusion set
EP1764122A1 (en) 2005-09-15 2007-03-21 F.Hoffmann-La Roche Ag Injection head with needle protection in the handle
JP2008508962A (en) * 2004-08-13 2008-03-27 ディセトロニック・ライセンシング・アクチェンゲゼルシャフト Insertion head for medical or pharmaceutical use
JP2009507584A (en) * 2005-09-15 2009-02-26 エフ．ホフマン−ラ ロシュ アーゲー Insertion head with needle protector in the handle
JP2009507583A (en) * 2005-09-15 2009-02-26 エフ．ホフマン−ラ ロシュ アーゲー Insertion head with needle protector in the handle
CN100528254C (en) * 2004-03-26 2009-08-19 优诺医疗有限公司 Injector device for infusion set
US7815607B2 (en) 2007-03-14 2010-10-19 Roche Diagnostics International Ag Insertion device for an insertion head, in particular for an infusion set
US7850652B2 (en) * 2007-03-14 2010-12-14 Roche Diagnostics International Ag Insertion head for medical or pharmaceutical applications
US8012126B2 (en) 2006-10-31 2011-09-06 Unomedical A/S Infusion set
US8062250B2 (en) 2004-08-10 2011-11-22 Unomedical A/S Cannula device
EP2495001A1 (en) * 2011-03-03 2012-09-05 Debiotech S.A. Cannula inserter
US8303549B2 (en) 2005-12-23 2012-11-06 Unomedical A/S Injection device
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