WO1994005362A9 - Device for introducing a catheter into the human body - Google Patents

Device for introducing a catheter into the human body

Info

Publication number
WO1994005362A9
WO1994005362A9 PCT/FR1993/000856 FR9300856W WO9405362A9 WO 1994005362 A9 WO1994005362 A9 WO 1994005362A9 FR 9300856 W FR9300856 W FR 9300856W WO 9405362 A9 WO9405362 A9 WO 9405362A9
Authority
WO
WIPO (PCT)
Prior art keywords
sleeve
flexible
sheath
flexible rod
flexible sheath
Prior art date
Application number
PCT/FR1993/000856
Other languages
French (fr)
Other versions
WO1994005362A1 (en
Filing date
Publication date
Priority claimed from FR9210699A external-priority patent/FR2695321B1/en
Application filed filed Critical
Publication of WO1994005362A1 publication Critical patent/WO1994005362A1/en
Publication of WO1994005362A9 publication Critical patent/WO1994005362A9/en

Links

Definitions

  • the present invention relates to a device for facilitating the introduction into the human body of a catheter.
  • a flexible rod constituted by a metal wire covered with a spiral metal sheath, this flexible shaft being introduced by its distal end through a hollow puncture needle in the vein, and advanced the desired length in it, to then serve as a guide to a catheter threaded on the flexible rod. Once the catheter is in the vein, the flexible guide rod is removed.
  • the flexible rod serving as a guide generally has end portions that are more flexible than its central region and that are elastically deformable, one of these end portions being at rest a rearward curved configuration in the shape of a 3, atraumatic, while the other end portion has a rectilinear configuration.
  • the flexible rod is usually introduced by its curved end 3, atraumatic, this end also making it easier to approach the venous branches.
  • the flexible rod is associated with a device for straightening the J-shaped end portion for its introduction into the proximal end of the hollow needle.
  • This device generally consists of a rigid sleeve threaded on the flexible rod by the rectilinear end portion thereof and that the practitioner moves towards the other end, that is to say in the direction of the curved end portion, so that the latter is deformed elastically in contact with the sleeve to take inside thereof a rectilinear configuration.
  • the flexible guide rod must necessarily have a length greater than that of the catheter that it will guide in sliding, and generally, for practical reasons, the practitioner chooses to use a flexible rod of about twice the length of the catheter to be introduced. which, in some applications, for example radiology, where the catheters have a large length, sometimes greater than 1 m, has a disadvantage.
  • the present invention relates to a device for overcoming the aforementioned drawbacks.
  • this device comprises a flexible rod to be introduced into the human body, to serve as a guide, once introduced, to a catheter threaded thereon, and a flexible protective sheath and aseptic engaged on the flexible rod, closed at one of its ends and. attached at the other end to a sleeve slidably mounted on said flexible rod, said flexible rod being adapted to extend through said sleeve outside said flexible sheath.
  • the sleeve comprises connection means on a hollow puncture needle base through which the flexible rod is introduced into the human body, and locking means on said base.
  • the connecting means are advantageously constituted by an annular groove formed between a tubular sleeve body and a cylindrical skirt extending facing said tubular body, open to the free end of the sleeve, and adapted to receive said base.
  • the locking means are advantageously constituted by a thread provided on the radially inner side of the cylindrical skirt.
  • the flexible sheath is fixed on the sleeve by means of a retaining ring 1 ' - * clamped thereon.
  • the device further comprises a second ring, engaged on the flexible sheath, initially mounted on the sleeve downstream of the retaining ring, for retaining on the sleeve, removably, a portion of flexible sheath I pleated having a length in unfolded state greater than the distance between the two rings measured along the axis of the sleeve, this second ring being able to move relative to the sleeve to a position releasing said folded flexible gain portion, when traction is exerted on the sleeve in the lining of the sheath.
  • the difference between the length of the folded flexible sheath portion in the unfolded state and the distance between the two rings measured along the axis of the sleeve is greater than the length of the curved portion 3 of the the flexible rod.
  • FIG. 1 is a diagrammatic partial view in longitudinal section of a device according to the invention
  • FIG. 1A is a diagrammatic view in longitudinal section of a sleeve according to the present invention
  • FIGS. 2 and 3 are diagrammatic views illustrating the use of the device according to the invention for straightening the bent portion 3 of the flexible rod extending out of the free end of the sleeve; -
  • the figure is a schematic view in partial longitudinal section of the device according to the invention, and a hollow puncture needle base,
  • FIG. 5 is a partial longitudinal sectional view showing the device and the base shown in the figure in the coupled position
  • FIG. 6 to 9 show different stages of the introduction of a catheter into a vein, thanks to the device according to the invention.
  • FIG. 1 is a diagrammatic longitudinal section of a device according to the present invention.
  • This device comprises a flexible rod 1 and a flexible sheath 2 of protection and aseptic of the flexible rod 1, the flexible sheath 2 being threaded onto the flexible rod 1, closed at one of its ends 2a and fixed to the other end 2b on a sleeve 3 slidably mounted on the flexible rod 1.
  • the flexible rod 1 is able to extend through the sleeve 3 outside the flexible sheath 2.
  • the rod flexible 1, of known type as described above, has at one end a curved portion shaped 3, and at the other end a rectilinear portion 1b.
  • the flexible rod 1 is introduced into the vein of the patient by its distal end la, the least traumatic.
  • FIG. 1A which shows the sleeve 3 in isolation, it can be seen that it is symmetrical about a longitudinal axis X and comprises, according to an advantageous characteristic of the invention, an annular groove 5 formed between a tubular sleeve body + and a cylindrical skirt 6 extending opposite the tubular body, open towards the free end 9 of the sleeve, through which the distal end portion 1a of the stem flexible 1.
  • This annular groove 5 serves to connect the sleeve 3 on a hollow puncture needle base as will be specified in the following.
  • the tubular body 4 has, from its free end 9 or front end, a tapered frustoconical portion 4a extended by a cylindrical portion b to the rear of which extends a transverse wall 10 constituting the bottom of said 5 and on the periphery of which is connected the cylindrical skirt 6.
  • the cylindrical portion 4b is extended downstream of the transverse wall 10 by a shoulder portion 4c of greater diameter.
  • the rear end edge 1 1 of the sleeve 3 comprises a countersink 8, centered on the longitudinal axis X, intended to facilitate the insertion of the flexible rod 1 into the sleeve during assembly of the surgical instrument according to the present invention. invention.
  • the cylindrical skirt 6 is threaded on its radially inner side 12 in order to lock the sleeve 3 on the aforementioned base, as will be seen hereinafter.
  • the flexible sheath 2 is fixed on the sleeve 3 by means of a retaining ring 13 clamped on the radially outer flank 14 of the cylindrical skirt 6.
  • the device comprises a second ring 15, preferably elastic, engaged on the flexible sheath 2 and initially mounted, as shown in Figure 1, downstream of the retaining ring 13 to retain on the sleeve 3 a portion of pleated flexible sheath 16 having a length in the unfolded state greater than the distance between the rings 13 and 15, deviation measured along the axis of the sleeve.
  • the free end 9 of the sleeve 3 is protected, without use, by a cap 17 removably mounted thereon.
  • a precut 18 extending on the periphery of the flexible sheath 2 and intended to facilitate the opening of the flexible sheath 2 by simple traction according to its longitudinal axis.
  • the flexible sheath 2 is fixed near its closed end 2a, set back from the pre-cut 18, on a sleeve 3 'identical to the sleeve 3 described above, oriented in opposite direction, and engaged on the flexible rod 1.
  • the flexible sheath 2 is fixed on the sleeve 3 'by a retaining ring 13' similar to the ring 13, clamped on the outer side 14 'of the cylindrical skirt 6' of this sleeve 3 '.
  • the use of the device according to the present invention is preferably carried out as will now be described, with reference to Figures 2 to 5.
  • the practitioner uses one hand, as shown in FIG. 2, with his other hand then available to immobilize the hollow puncture needle during the introduction of the stalk. flexible through it and thus avoid the risk of accidental perforation of the vein.
  • the flexible sheath 2 and the flexible rod are held against the palm of the hand by the little finger, the ring finger and the middle finger, while the thumb and forefinger hold the sleeve 3.
  • the sleeve 3 is then driven, at the the thumb and forefinger in the direction of the arrow F of Figure 3 while the flexible sheath 2 and the flexible rod 1 are held in place by the other three fingers.
  • the sleeve 3 moves relative to the flexible rod 1 which deforms elastically to take a rectilinear configuration inside thereof, as shown in FIG. 4.
  • the second ring 15 under the effect of the traction exerted on the sleeve, leaving it, and thus releases the folded sheath portion 16 which can then unfold, driven by the sleeve 3.
  • the difference in length between the length of the portion of sheath folded and the gap between the rings 13 and 15 is greater than the length of the curved portion J-shaped, so that the distal end of the flexible stem 1 can be housed using a single traction exerted on the sleeve 3, completely inside thereof, as shown in Figure 4, and the sleeve 3 can then be introduced into the base 20 of a hollow puncture needle 21.
  • This hollow puncture needle 21 compor a metal body 22, hollow, provided at its distal end with a beveled tip to be introduced into the vein and is extended externally at its proximal end by the base 20, generally made of plastic and having an internal surface complementary to the surface; external part of the tapered portion of the sleeve 3.
  • the base 20 has at its free end a cylindrical wall 23 threaded on its outer side adapted to engage by screwing in the annular groove 5 to achieve the configuration shown in Figure 5. During these operations, the flexible rod portion 1 extending downstream of the end 1a has remained effectively protected by the flexible sheath 2.
  • connection of the sleeve 3 to the base 20 for example by rendering the cylindrical skirt 6, elastically deformable radially, the coupling between the base 20 and the sleeve 3 then being made by elastic deformation of the cylindrical skirt 6 during insertion of the base 20 into the groove 5.
  • FIGS. 6 to 9 show the different stages of placing a catheter with the device according to the invention.
  • a catheter C is threaded through the proximal end 1b of the flexible shaft 1 thereon and is slidably guided by the flexible shaft 1 into the vein V of the patient.
  • the flexible shaft 1 is removed, as shown in FIG. 9.
  • the flexible shaft may be inserted into the hollow puncture needle through its straight end portion 1b, after opening. the end 2a of the sheath 2 according to the precut 18.
  • a device according to the present invention makes it possible to place a catheter in a more secure manner, in particular by allowing the practitioner to straighten the curved portion in the shape of 3 with one hand, the other hand being able to keep the needle hollow and avoid any accidental risk of perforation of the vein.
  • the f lexible rod 1 is effectively protected against the risk of contamination by the flexible sheath 2, and it also retains the blood that could flow through the clearance left between the hollow needle and the rod flexible 1.

Abstract

The device comprises a flexible rod (1) to be introduced into the human body as a guide (1), when introduced, for a catheter passed thereon, and a flexible, protective aseptic sheath (2) on the flexible rod, closed at one of its ends (2a) and attached at the other end (2b) to a sleeve (3) slidingly mounted on the flexible rod, said flexible rod being extendable through said sleeve beyond said flexible sheath.

Description

DISPOSITIF SERVANT A L'INTRODUCTION D'UN CATHETER DANS LE CORPS HUMAIN DEVICE FOR THE INTRODUCTION OF A CATHETER IN THE HUMAN BODY
La présente invention concerne un dispositif pour faciliter l'introduction dans le corps humain d'un cathéter.The present invention relates to a device for facilitating the introduction into the human body of a catheter.
Il est connu d'utiliser, pour introduire un cathéter dans le corps humain, et plus particulièrement dans une veine, une tige flexible constituée par un fil métallique recouvert d'une gaine métallique spiralée, cette tige flexible étant introduite par son extrémité distale au travers d'une aiguille creuse de ponction dans la veine, et avancée de la longueur voulue dans celle-ci, pour servir ensuite de guide à un cathéter enfilé sur la tige flexible. Une fois le cathéter en place dans la veine, la tige flexible servant de guide est retirée.It is known to use, for introducing a catheter into the human body, and more particularly into a vein, a flexible rod constituted by a metal wire covered with a spiral metal sheath, this flexible shaft being introduced by its distal end through a hollow puncture needle in the vein, and advanced the desired length in it, to then serve as a guide to a catheter threaded on the flexible rod. Once the catheter is in the vein, the flexible guide rod is removed.
La tige flexible servant de guide présente généralement des parties d'extrémité plus souples que sa région centrale, déformables elastiquement, l'une de ces parties d'extrémité prenant au repos une configuration recourbée vers l'arrière, en forme de 3, atraumatique, tandis que l'autre partie d'extrémité présente une configuration rectiligne.The flexible rod serving as a guide generally has end portions that are more flexible than its central region and that are elastically deformable, one of these end portions being at rest a rearward curved configuration in the shape of a 3, atraumatic, while the other end portion has a rectilinear configuration.
La tige flexible est habituellement introduite par son extrémité recourbée en forme de 3, atraumatique, cette extrémité permettant en outre d'aborder plus facilement les embranchements veineux. Dans ce cas, la tige flexible est associée à un dispositif permettant de redresser la partie d'extrémité en forme de J, pour son introduction dans l'extrémité proximale de l'aiguille creuse. Ce dispositif consiste générale¬ ment en un manchon rigide enfilé sur la tige flexible par la partie d'extrémité rectiligne de celle-ci et que le praticien déplace en direction de l'autre extrémité, c'est-à-dire en direction de la partie d'extrémité recourbée, de sorte que cette dernière se déforme elastiquement au contact du manchon pour prendre à l'intérieur de celui-ci une configuration rectiligne. Ensuite, lorsque la partie d'extrémité recourbée est complète¬ ment logée dans le manchon, l'ouverture de celui-ci est positionnée en regard et au contact de l'ouverture proximale de l'aiguille creuse et la tige flexible est poussée à travers le manchon dans l'aiguille. A la sortie de l'aiguille creuse, c'est-à-dire dans la veine, la tige flexible reprend naturellement sa configuration recourbée en forme de 3, atraumatique. La tige flexible servant de guide doit nécessairement présenter une longueur supérieure à celle du cathéter qu'elle guidera en coulissement, et généralement, pour des raisons pratiques, le praticien choisit d'employer une tige flexible de longueur double environ de celle du cathéter à introduire, ce qui, dans certaines appJications, par exemple la radiologie, où les cathéters ont une longueur importante, parfois supérieure à 1 m, présente un inconvénient. En effet, lors de son introduction, la tige flexible, nue, est exposée au contact d'objets septiques (lit du malade, blouse du médecin ...). H a été proposé, pour tenter de remédier à cet inconvénient, de livrer la tige flexible enroulée dans un étui protecteur semi-rigide en forme de portion de tore, mais, dans ce cas, l'enroulement de la tige flexible modifie les propriétés mécaniques de flexibilité de la gaine spiralée, notamment au niveau de la partie d'extrémité recourbée en forme de J.The flexible rod is usually introduced by its curved end 3, atraumatic, this end also making it easier to approach the venous branches. In this case, the flexible rod is associated with a device for straightening the J-shaped end portion for its introduction into the proximal end of the hollow needle. This device generally consists of a rigid sleeve threaded on the flexible rod by the rectilinear end portion thereof and that the practitioner moves towards the other end, that is to say in the direction of the curved end portion, so that the latter is deformed elastically in contact with the sleeve to take inside thereof a rectilinear configuration. Then, when the curved end portion is completely housed in the sleeve, the opening thereof is positioned opposite and in contact with the proximal opening of the hollow needle and the flexible rod is pushed through the sleeve in the needle. At the exit of the hollow needle, that is to say in the vein, the flexible stem naturally resumes its curved configuration in the form of atraumatic 3. The flexible guide rod must necessarily have a length greater than that of the catheter that it will guide in sliding, and generally, for practical reasons, the practitioner chooses to use a flexible rod of about twice the length of the catheter to be introduced. which, in some applications, for example radiology, where the catheters have a large length, sometimes greater than 1 m, has a disadvantage. Indeed, during its introduction, the flexible rod, bare, is exposed to contact with septic objects (bed of the patient, doctor's coat ...). It has been proposed, in an attempt to overcome this drawback, to deliver the flexible rod wound in a semi-rigid protective case in the form of a portion of a torus, but in this case the winding of the flexible rod modifies the mechanical properties. flexibility of the spiral sheath, especially at the end portion bent in the form of J.
Par ailleurs, pendant la durée de mise en place de la tige flexible dans la veine du patient, du sang a tendance à s'infiltrer par l'extrémité distale de l'aiguille creuse dans le jeu compris entre la tige flexible et la lumière de l'aiguille pour s'écouler à l'air libre à l'extrémité proximale de l'aiguille et par exemple venir en contact direct avec les doigts du praticien.Moreover, during the period of placement of the flexible shaft in the patient's vein, blood tends to seep through the distal end of the hollow needle in the clearance between the flexible shaft and the lumen of the patient. the needle to flow freely to the proximal end of the needle and for example come into direct contact with the practitioner's fingers.
La présente invention a pour objet un dispositif permettant de remédier aux inconvénients précités.The present invention relates to a device for overcoming the aforementioned drawbacks.
Selon une première caractéristique de l'invention, ce dispositif comprend une tige flexible à introduire dans le corps humain, pour servir de guide, une fois introduite, à un cathéter enfilé sur celle-ci, et une gaine souple de protection et d'aseptie engagée sur la tige flexible, fermée à l'une de ses extrémités et . fixée à l'autre extrémité sur un manchon monté à coulissement sur ladite tige flexible, ladite tige flexible étant apte à s'étendre au travers dudit manchon en dehors de ladite gaine souple.According to a first characteristic of the invention, this device comprises a flexible rod to be introduced into the human body, to serve as a guide, once introduced, to a catheter threaded thereon, and a flexible protective sheath and aseptic engaged on the flexible rod, closed at one of its ends and. attached at the other end to a sleeve slidably mounted on said flexible rod, said flexible rod being adapted to extend through said sleeve outside said flexible sheath.
Selon une autre caractéristique de l'invention, le manchon comporte des moyens de raccordement sur une embase d'aiguille creuse de ponction au travers de laquelle la tige flexible est introduite dans le corps humain, et des moyens de verrouillage sur ladite embase. Les moyens de raccordement sont avantageusement constitués par une gorge annulaire ménagée entre un corps de manchon tubulaire et une jupe cylindrique s'étendant en regard dudit corps tubulaire, ouverte \ ers l'extrémité libre du manchon, et apte à recevoir ladite embase. "> Dans ce cas, les moyens de verrouillage sont avantageusement constitués par un filetage prévu sur le flanc radialement interne de la jupe cylindrique.According to another characteristic of the invention, the sleeve comprises connection means on a hollow puncture needle base through which the flexible rod is introduced into the human body, and locking means on said base. The connecting means are advantageously constituted by an annular groove formed between a tubular sleeve body and a cylindrical skirt extending facing said tubular body, open to the free end of the sleeve, and adapted to receive said base. In this case, the locking means are advantageously constituted by a thread provided on the radially inner side of the cylindrical skirt.
Selon une autre caractéristique avantageuse de l'invention, la gaine souple est fixée sur le manchon au moyen d'une bague de maintien 1 '-* serrée sur celui-ci.According to another advantageous characteristic of the invention, the flexible sheath is fixed on the sleeve by means of a retaining ring 1 ' - * clamped thereon.
Selon une autre caractéristique avantageuse, le dispositif comporte de plus une deuxième bague, engagée sur la gaine souple, initialement montée sur le manchon en aval de la bague de maintien, pour retenir sur le manchon, de façon amovible, une portion de gaine souple I ^ plissée ayant une longueur à l'état déplié supérieure à l'écart entre les deux bagues mesuré selon l'axe du manchon, cette deuxième bague étant susceptible de se déplacer par rapport au manchon vers une position libérant ladite portion de gain souple plissée, lorsqu'une traction est exercée sur le manchon en éioignement de la gaine. 0 De préférence, la différence entre la longueur de la portion de gaine souple plissée à l'état déplié et l'écart entre les deux bagues mesuré selon l'axe du manchon est supérieure à la longueur de la partie recourbée en forme de 3 de la tige flexible.According to another advantageous characteristic, the device further comprises a second ring, engaged on the flexible sheath, initially mounted on the sleeve downstream of the retaining ring, for retaining on the sleeve, removably, a portion of flexible sheath I pleated having a length in unfolded state greater than the distance between the two rings measured along the axis of the sleeve, this second ring being able to move relative to the sleeve to a position releasing said folded flexible gain portion, when traction is exerted on the sleeve in the lining of the sheath. Preferably, the difference between the length of the folded flexible sheath portion in the unfolded state and the distance between the two rings measured along the axis of the sleeve is greater than the length of the curved portion 3 of the the flexible rod.
D'autres caractéristiques et avantages de la présente invention 5 apparaîtront à la lecture de la description qui va suivre, d'un exemple de réalisation non limitatif de l'invention, et à l'examen du dessin annexé sur lequel :Other characteristics and advantages of the present invention will appear on reading the following description of a nonlimiting exemplary embodiment of the invention and on examining the appended drawing in which:
- la figure 1 est une vue schématique, partielle, en coupe longitudinale d'un dispositif conforme à l'invention, 0 - la figure 1A est une vue schématique en coupe longitudinale d'un manchon conforme à la présente invention,FIG. 1 is a diagrammatic partial view in longitudinal section of a device according to the invention; FIG. 1A is a diagrammatic view in longitudinal section of a sleeve according to the present invention;
- les figures 2 et 3 sont des vues schématiques illustrant l'utilisation du dispositif selon l'invention pour redresser la partie recourbée en forme de 3 de la tige flexible s'étendant hors de l'extrémité libre du manchon, - la figure est une vue schématique en coupe longitudinale partielle du dispositif conforme à l'invention, et d'une embase d'aiguille creuse de ponction,FIGS. 2 and 3 are diagrammatic views illustrating the use of the device according to the invention for straightening the bent portion 3 of the flexible rod extending out of the free end of the sleeve; - The figure is a schematic view in partial longitudinal section of the device according to the invention, and a hollow puncture needle base,
- la figure 5 est une vue en coupe longitudinale partielle montrant le dispositif et l'embase représentés sur la figure en position accouplée,FIG. 5 is a partial longitudinal sectional view showing the device and the base shown in the figure in the coupled position,
- les figures 6 à 9 montrent différentes étapes de l'introduction d'un cathéter dans une veine, grâce au dispositif selon l'invention.- Figures 6 to 9 show different stages of the introduction of a catheter into a vein, thanks to the device according to the invention.
On a représenté sur la figure 1, en coupe longitudinale schématique, un dispositif conforme à la présente invention. Ce dispositif comprend une tige flexible 1 et une gaine souple 2 de protection et d'aseptie de la tige flexible 1 , la gaine souple 2 étant enfilée sur la tige flexible 1, fermée à l'une de ses extrémités 2a et fixée à l'autre extrémité 2b sur un manchon 3 monté à coulissement sur la tige flexible 1. Conformément à une caractéristique de l'invention, la tige flexible 1 est apte à s'étendre au travers du manchon 3 en dehors de la gaine souple 2. La tige flexible 1, de type connu comme décrit précédemment, comporte à une extrémité une portion l a recourbée en forme de 3, et à l'autre extrémité une portion rectiligne lb.FIG. 1 is a diagrammatic longitudinal section of a device according to the present invention. This device comprises a flexible rod 1 and a flexible sheath 2 of protection and aseptic of the flexible rod 1, the flexible sheath 2 being threaded onto the flexible rod 1, closed at one of its ends 2a and fixed to the other end 2b on a sleeve 3 slidably mounted on the flexible rod 1. According to a characteristic of the invention, the flexible rod 1 is able to extend through the sleeve 3 outside the flexible sheath 2. The rod flexible 1, of known type as described above, has at one end a curved portion shaped 3, and at the other end a rectilinear portion 1b.
De préférence, comme cela sera précisé dans la suite, la tige flexible 1 est introduite dans la veine du patient par son extrémité distale la, la moins traumatique. Si l'on se reporte plus particulièrement à la figure 1A, qui montre isolément le manchon 3, on remarque que celui-ci est symétrique de révolution autour d'un axe longitudinal X et comporte, conformément à une caractéristique avantageuse de l'invention, une gorge annulaire 5 ménagée entre un corps de manchon tubulaire -+ et une jupe cylindrique 6 s'étendant en regard du corps tubulaire , ouverte vers l'extrémité libre 9 du manchon, par laquelle sort la partie d'extrémité distale la de la tige flexible 1. Cette gorge annulaire 5 sert au raccordement du manchon 3 sur une embase d'aiguille creuse de ponction comme cela sera précisé dans la suite. De préférence, comme représenté, le corps tubulaire 4 présente, depuis son extrémité libre 9 ou extrémité avant, une partie tronconique effilée 4a prolongée par une partie cylindrique b à l'arrière de laquelle s'étend une paroi transversale 10 constituant le fond de ladite gorge 5 et sur la périphérie de laquelle se raccorde la jupe cylindrique 6. La partie cylindrique 4b se prolonge, en aval de la paroi transversale 10 par une portion épaulée 4c de diamètre supérieur. La tranche d'extrémité arrière 1 1 du manchon 3 comporte une fraisure 8, centrée sur l'axe longitudinal X, destinée à faciliter l'insertion de la tige flexible 1 dans le manchon lors du montage de l'instrument chirurgical conforme à la présente invention. On remarquera que la jupe cylindrique 6 est filetée sur son flanc radialement interne 12 en vue du verrouillage du manchon 3 sur l'embase précitée, comme cela sera vu dans la suite.Preferably, as will be specified in the following, the flexible rod 1 is introduced into the vein of the patient by its distal end la, the least traumatic. Referring more particularly to FIG. 1A, which shows the sleeve 3 in isolation, it can be seen that it is symmetrical about a longitudinal axis X and comprises, according to an advantageous characteristic of the invention, an annular groove 5 formed between a tubular sleeve body + and a cylindrical skirt 6 extending opposite the tubular body, open towards the free end 9 of the sleeve, through which the distal end portion 1a of the stem flexible 1. This annular groove 5 serves to connect the sleeve 3 on a hollow puncture needle base as will be specified in the following. Preferably, as shown, the tubular body 4 has, from its free end 9 or front end, a tapered frustoconical portion 4a extended by a cylindrical portion b to the rear of which extends a transverse wall 10 constituting the bottom of said 5 and on the periphery of which is connected the cylindrical skirt 6. The cylindrical portion 4b is extended downstream of the transverse wall 10 by a shoulder portion 4c of greater diameter. The rear end edge 1 1 of the sleeve 3 comprises a countersink 8, centered on the longitudinal axis X, intended to facilitate the insertion of the flexible rod 1 into the sleeve during assembly of the surgical instrument according to the present invention. invention. It will be noted that the cylindrical skirt 6 is threaded on its radially inner side 12 in order to lock the sleeve 3 on the aforementioned base, as will be seen hereinafter.
Selon une caractéristique avantageuse de l'invention, la gaine souple 2 est fixée sur le manchon 3 au moyen d'une bague de maintien 13 serrée sur le flanc radialement externe 14 de la jupe cylindrique 6.According to an advantageous characteristic of the invention, the flexible sheath 2 is fixed on the sleeve 3 by means of a retaining ring 13 clamped on the radially outer flank 14 of the cylindrical skirt 6.
Conformément à une autre caractéristique avantageuse de l'invention, le dispositif comporte une deuxième bague 15, de préférence élastique, engagée sur la gaine souple 2 et initialement montée, comme représenté sur la figure 1, en aval de la bague de maintien 13 pour retenir sur le manchon 3 une portion de gaine souple plissée 16 ayant une longueur à l'état déplié supérieure à l'écart entre les bagues 13 et 15, écart mesuré selon l'axe du manchon.According to another advantageous characteristic of the invention, the device comprises a second ring 15, preferably elastic, engaged on the flexible sheath 2 and initially mounted, as shown in Figure 1, downstream of the retaining ring 13 to retain on the sleeve 3 a portion of pleated flexible sheath 16 having a length in the unfolded state greater than the distance between the rings 13 and 15, deviation measured along the axis of the sleeve.
De préférence, comme représenté, l'extrémité libre 9 du manchon 3 est protégée, hors utilisation, par un capuchon 17 monté de façon amovible sur celui-ci.Preferably, as shown, the free end 9 of the sleeve 3 is protected, without use, by a cap 17 removably mounted thereon.
Avantageusement, il est prévu, légèrement en retrait de l'extrémité 2a de la gaine souple 2 une prédécoupe 18 s'étendant sur la périphérie de la gaine souple 2 et visant à faciliter l'ouverture de la gaine souple 2 par simple traction selon son axe longitudinal. De préférence également, comme représenté sur la figure 1, la gaine souple 2 est fixée à proximité de son extrémité fermée 2a, en retrait de la prédécoupe 18, sur un manchon 3' identique au manchon 3 précédemment décrit, orienté en sens inverse, et engagé sur la tige flexible 1. La gaine souple 2 est fixée sur le manchon 3' par une bague de maintient 13' similaire à la bague 13, serrée sur le flanc externe 14' de la jupe cylindrique 6' de ce manchon 3'. L'utilisation du dispositif conforme à la présente invention s'effectue de préférence comme cela va maintenant être décrit, en référence aux figures 2 à 5.Advantageously, there is provided, slightly behind the end 2a of the flexible sheath 2, a precut 18 extending on the periphery of the flexible sheath 2 and intended to facilitate the opening of the flexible sheath 2 by simple traction according to its longitudinal axis. Also preferably, as shown in Figure 1, the flexible sheath 2 is fixed near its closed end 2a, set back from the pre-cut 18, on a sleeve 3 'identical to the sleeve 3 described above, oriented in opposite direction, and engaged on the flexible rod 1. The flexible sheath 2 is fixed on the sleeve 3 'by a retaining ring 13' similar to the ring 13, clamped on the outer side 14 'of the cylindrical skirt 6' of this sleeve 3 '. The use of the device according to the present invention is preferably carried out as will now be described, with reference to Figures 2 to 5.
Pour redresser la partie d'extrémité en forme de 3, le praticien se sert d'une seule main, comme illustré sur la figure 2, son autre main étant alors disponible pour immobiliser l'aiguille creuse de ponction pendant l'introduction de la tige flexible au travers de celle-ci et ainsi éviter les risques de perforation accidentels de la veine. La gaine souple 2 et la tige flexible sont maintenues contre la paume de la main par l'auriculaire, l'annulaire et le majeur, tandis que le pouce et l'index tiennent le manchon 3. Le manchon 3 est alors entraîné, à l'aide du pouce et de l'index dans le sens de la flèche F de la figure 3 tandis que la gaine souple 2 et la tige flexible 1 sont retenues en place par les trois autres doigts. Dans ce mouvement, le manchon 3 se déplace relativement à la tige flexible 1 qui se déforme elastiquement pour prendre une configuration rectiligne à l'intérieur de celui-ci, comme représenté sur la figure 4. Lors de ce mouvement, la deuxième bague 15, sous l'effet de la traction exercée sur le manchon, quitte celui-ci, et libère ainsi la portion de gaine plissée 16 qui peut alors se déplier, entraînée par le manchon 3. De préférence, la différence de longueur entre la longueur de la portion de gaine plissée et l'écart entre les bagues 13 et 15 est supérieure à la longueur de la partie recourbée en forme de J, de sorte que l'extrémité distale la de la tige flexible 1 peut-venir se loger à l'aide d'une seule traction exercée sur le manchon 3, complètement à l'intérieur de celui-ci, comme représenté sur la figure 4, et le manchon 3 peut ensuite être introduit dans l'embase 20 d'une aiguille creuse de ponction 21. Cette aiguille creuse de ponction 21 comporte un corps métallique 22, creux, muni à son extrémité distale d'une pointe biseautée à introduire dans la veine et est prolongé extérieurement à son extrémité proximale par l'embase 20, généralement en matière plastique et présentant une surface interne complémentaire de la surface externe de la partie effilée du manchon 3. L'embase 20 présente à son extrémité libre une paroi cylindrique 23 filetée sur son flanc externe apte à s'engager par vissage dans la gorge annulaire 5 pour aboutir à la configuration représentée sur la figure 5. Pendant ces opérations, la partie de tige flexible 1 s'étendant en aval de l'extrémité la est restée protégée de façon efficace par la gaine souple 2.To straighten the 3-shaped end portion, the practitioner uses one hand, as shown in FIG. 2, with his other hand then available to immobilize the hollow puncture needle during the introduction of the stalk. flexible through it and thus avoid the risk of accidental perforation of the vein. The flexible sheath 2 and the flexible rod are held against the palm of the hand by the little finger, the ring finger and the middle finger, while the thumb and forefinger hold the sleeve 3. The sleeve 3 is then driven, at the the thumb and forefinger in the direction of the arrow F of Figure 3 while the flexible sheath 2 and the flexible rod 1 are held in place by the other three fingers. In this movement, the sleeve 3 moves relative to the flexible rod 1 which deforms elastically to take a rectilinear configuration inside thereof, as shown in FIG. 4. During this movement, the second ring 15, under the effect of the traction exerted on the sleeve, leaving it, and thus releases the folded sheath portion 16 which can then unfold, driven by the sleeve 3. Preferably, the difference in length between the length of the portion of sheath folded and the gap between the rings 13 and 15 is greater than the length of the curved portion J-shaped, so that the distal end of the flexible stem 1 can be housed using a single traction exerted on the sleeve 3, completely inside thereof, as shown in Figure 4, and the sleeve 3 can then be introduced into the base 20 of a hollow puncture needle 21. This hollow puncture needle 21 compor a metal body 22, hollow, provided at its distal end with a beveled tip to be introduced into the vein and is extended externally at its proximal end by the base 20, generally made of plastic and having an internal surface complementary to the surface; external part of the tapered portion of the sleeve 3. The base 20 has at its free end a cylindrical wall 23 threaded on its outer side adapted to engage by screwing in the annular groove 5 to achieve the configuration shown in Figure 5. During these operations, the flexible rod portion 1 extending downstream of the end 1a has remained effectively protected by the flexible sheath 2.
On pourrait bien entendu proposer, sans sortir du cadre de la présente invention, une réalisation différente du raccordement du manchon 3 sur l'embase 20, par exemple en rendant deformable elastiquement radialement la jupe cylindrique 6, l'accouplement entre l'embase 20 et le manchon 3 se faisant alors par déformation élastique de la jupe cylindrique 6 lors de l'insertion de l'embase 20 dans la gorge 5.It would of course be possible to propose, without departing from the scope of the present invention, a different embodiment of the connection of the sleeve 3 to the base 20, for example by rendering the cylindrical skirt 6, elastically deformable radially, the coupling between the base 20 and the sleeve 3 then being made by elastic deformation of the cylindrical skirt 6 during insertion of the base 20 into the groove 5.
On a représenté sur les figures 6 à 9, les différentes étapes de mise en place d'un cathéter grâce au dispositif selon l'invention. Une fois la tige flexible 1 introduite dans l'aiguille creuse de ponction 21, comme cela a été précédemment décrit en référence aux figures 2 à 5, l'aiguille 21 est introduite dans la veine V d'un patient, et la tige flexible 1 est déplacée dans l'aiguille creuse 21 jusqu'à atteindre l'extrémité distale de celle-ci, la partie de l'extrémité distale la reprenant alors naturellement dans la veine sa configuration recourbée en forme de 3, comme représenté sur la figure 6. La tige flexible 1 est poussée dans la veine V sur la longueur voulue, puis la veine V est comprimée localement comme montré sur la figure 7 et l'aiguille creuse 21 est retirée, laissant en place la tige flexible 1 dans la veine. Alors, comme représenté sur la figure 8, un cathéter C est enfilé par l'extrémité proximale lb de la tige flexible 1 sur celle-ci et est guidé à coulissement par la tige flexible 1 dans la veine V du patient. Une fois le cathéter en place, la tige flexible 1 est retirée, comme illustré sur la figure 9. Le cas échéant, la tige flexible peut être introduite dans l'aiguille creuse de ponction par sa partie d'extrémité rectiligne lb, après ouverture de l'extrémité 2a de la gaine 2 selon la prédécoupe 18. Finalement, un dispositif conforme à la présente invention permet la mise en place d'un cathéter d'une façon plus sûre, en permettant notamment au praticien de redresser la partie recourbée en forme de 3 d'une seule main, l'autre main pouvant maintenir l'aiguille creuse et éviter ainsi tout risque accidentel de perforation de la veine. D'autre part, la tige f lexible 1 est efficacement protégée contre les risques de contamination par la gaine souple 2, et celle-ci retient en outre le sang qui pourrait s'écouler par le jeu laissé entre l'aiguille creuse et la tige flexible 1.FIGS. 6 to 9 show the different stages of placing a catheter with the device according to the invention. Once the flexible rod 1 has been introduced into the hollow puncture needle 21, as has been previously described with reference to FIGS. 2 to 5, the needle 21 is introduced into the vein V of a patient, and the flexible rod 1 is moved in the hollow needle 21 to reach the distal end thereof, the portion of the distal end then taking again naturally in the vein its curved configuration in the form of 3, as shown in Figure 6. The flexible rod 1 is pushed into the vein V over the desired length, then the vein V is compressed locally as shown in Figure 7 and the hollow needle 21 is removed, leaving in place the flexible rod 1 in the vein. Then, as shown in Fig. 8, a catheter C is threaded through the proximal end 1b of the flexible shaft 1 thereon and is slidably guided by the flexible shaft 1 into the vein V of the patient. Once the catheter is in place, the flexible shaft 1 is removed, as shown in FIG. 9. If appropriate, the flexible shaft may be inserted into the hollow puncture needle through its straight end portion 1b, after opening. the end 2a of the sheath 2 according to the precut 18. Finally, a device according to the present invention makes it possible to place a catheter in a more secure manner, in particular by allowing the practitioner to straighten the curved portion in the shape of 3 with one hand, the other hand being able to keep the needle hollow and avoid any accidental risk of perforation of the vein. On the other hand, the f lexible rod 1 is effectively protected against the risk of contamination by the flexible sheath 2, and it also retains the blood that could flow through the clearance left between the hollow needle and the rod flexible 1.
ι :ι:
1 51 5
2020
55
0 0

Claims

REVENDICATIONS
1/ Dispositif comprenant une tige flexible (1) à introduire dans le corps humain, pour servir de guide, une fois introduite, à un cathéter (C) enfilé sur celle-ci, et une gaine souple (2) de protection et d'aseptie engagée sur la tige flexible, fermée à l'une (2a) de ses extrémités et fixée à l'autre (2b) extrémité sur un manchon (3) monté à coulissement sur ladite tige flexible, ladite tige flexible étant apte à s'étendre au travers dudit manchon en dehors de ladite gaine souple. 2/ Dispositif selon la revendication 1, caractérisé en ce que le manchon comporte des moyens de raccordement sur une embase (20) d'aiguille creuse de ponction (21) au travers de laquelle la tige flexible est introduite dans le corps humain, et des moyens de verrouillage sur ladite embase. 3/ Dispositif selon la revendication 2, caractérisé en ce que les moyens de raccordement sont constitués par une gorge annulaire (5) ménagée entre un corps de manchon tubulaire (4) et une jupe cylindrique (6) s'étendant en regard dudit corps tubulaire, ouverte vers l'extrémité libre (9) du manchon, et propre à recevoir ladite embase. 4/ Dispositif selon la revendication 3, caractérisé en ce que les moyens de verrouillage sont constitués par un filetage prévu sur le flanc radialement interne (12) de la jupe cylindrique.1 / Device comprising a flexible rod (1) to be introduced into the human body, to serve as a guide, once introduced, to a catheter (C) threaded thereon, and a flexible sheath (2) for protection and aseptic engaged on the flexible rod, closed at one (2a) of its ends and fixed to the other (2b) end on a sleeve (3) slidably mounted on said flexible rod, said flexible rod being adapted to s' extend through said sleeve outside said flexible sheath. 2 / Apparatus according to claim 1, characterized in that the sleeve comprises connection means on a base (20) of hollow puncture needle (21) through which the flexible rod is introduced into the human body, and locking means on said base. 3 / Apparatus according to claim 2, characterized in that the connecting means are constituted by an annular groove (5) formed between a tubular sleeve body (4) and a cylindrical skirt (6) extending opposite said tubular body , open towards the free end (9) of the sleeve, and adapted to receive said base. 4 / Apparatus according to claim 3, characterized in that the locking means are constituted by a thread provided on the radially inner flank (12) of the cylindrical skirt.
5/ Dispositif selon l'une des revendications 1 à 4, caractérisé en ce que la gaine souple est fixée sur le manchon au moyen d'une bague de maintien (13) serrée sur celui-ci.5 / Apparatus according to one of claims 1 to 4, characterized in that the flexible sheath is fixed on the sleeve by means of a retaining ring (13) clamped thereon.
6/ Dispositif selon la revendication 5, caractérisé en ce qu'il comporte une deuxième bague (15), engagée sur la gaine souple, initialement montée sur le manchon en aval de la bague de maintien, pour retenir sur le manchon, de façon amovible, une portion (16) de gaine souple plissée ayant une longueur à l'état déplié supérieure à l'écart entre les deux bagues, mesuré selon l'axe du manchon, cette deuxième bague étant susceptible de se déplacer par rapport au manchon vers une position libérant ladite portion de gaine souple plissée, lorsqu'une traction est exercée sur le manchon en éloignement de la gaine. 7/ Dispositif selon la revendication 6, caractérisé en ce que la différence de longueur entre la longueur de la portion de gaine souple plissée à l'état déplié et l'écart entre les deux bagues mesuré selon l'axe du manchon est supérieure à la longueur de la partie recourbée en forme de J de la tige flexible.6 / Apparatus according to claim 5, characterized in that it comprises a second ring (15) engaged on the flexible sheath, initially mounted on the sleeve downstream of the retaining ring, to retain on the sleeve, removably , a portion (16) of pleated flexible sheath having a length in unfolded state greater than the distance between the two rings, measured along the axis of the sleeve, this second ring being able to move relative to the sleeve towards a position releasing said portion of pleated flexible sheath, when traction is exerted on the sleeve away from the sheath. 7 / Apparatus according to claim 6, characterized in that the length difference between the length of the pleated flexible sheath portion in the unfolded state and the distance between the two rings measured along the axis of the sleeve is greater than the length of the curved J-shaped portion of the flexible rod.
8/ Dispositif selon la revendication 6 ou 7, caractérisé en ce que la deuxième bague est élastique.8 / Apparatus according to claim 6 or 7, characterized in that the second ring is elastic.
9/ Dispositif selon l'une des revendications 1 à 8, caractérisé en ce que la gaine souple comporte, au voisinage de son extrémité fermée (2a) une prédécoupe (18).9 / Apparatus according to one of claims 1 to 8, characterized in that the flexible sheath comprises, in the vicinity of its closed end (2a) a precut (18).
10/ Dispositif selon la revendication 9, caractérisé en ce que la gaine souple est fixée à proximité de son extrémité fermée (2a), en retrait de la prédécoupe (18) sur un deuxième manchon (13') identique du premier, orienté en sens inverse, et engagé sur la tige flexible. 10 / Apparatus according to claim 9, characterized in that the flexible sheath is fixed close to its closed end (2a), set back from the pre-cut (18) on a second sleeve (13 ') identical to the first, oriented in direction reverse, and engaged on the flexible rod.
PCT/FR1993/000856 1992-09-08 1993-09-07 Device for introducing a catheter into the human body WO1994005362A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
FR92/10699 1992-09-08
FR9210699A FR2695321B1 (en) 1992-09-08 1992-09-08 Device for introducing a catheter into the human body.

Publications (2)

Publication Number Publication Date
WO1994005362A1 WO1994005362A1 (en) 1994-03-17
WO1994005362A9 true WO1994005362A9 (en) 1994-04-28

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WO (1) WO1994005362A1 (en)

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DK173714B1 (en) * 1998-11-20 2001-07-16 Coloplast As Urinary catheter device with integrated catheter extension
US6537254B1 (en) * 1999-07-06 2003-03-25 Datascope Investment Corp. Universal protective catheter sleeve

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2120413A5 (en) * 1970-12-31 1972-08-18 Durand Herve
US4834710A (en) * 1987-10-08 1989-05-30 Arrow International Investment Corporation Catheter shield and test structure
DE4008391C1 (en) * 1990-03-16 1991-10-17 Vygon Gmbh & Co Kg, 5100 Aachen, De
CA2087733C (en) * 1990-09-21 2002-07-02 Randal W. Woodgrift Adjustable catheter contamination shield

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