EP0938278A1 - Apparatus for setting and removing parts such as endoprostheses - Google Patents

Apparatus for setting and removing parts such as endoprostheses

Info

Publication number
EP0938278A1
EP0938278A1 EP98933679A EP98933679A EP0938278A1 EP 0938278 A1 EP0938278 A1 EP 0938278A1 EP 98933679 A EP98933679 A EP 98933679A EP 98933679 A EP98933679 A EP 98933679A EP 0938278 A1 EP0938278 A1 EP 0938278A1
Authority
EP
European Patent Office
Prior art keywords
jaws
sheath
tool
rod
wire guide
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP98933679A
Other languages
German (de)
French (fr)
Inventor
Jean-Noel Bernard
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Individual
Original Assignee
Individual
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 Individual filed Critical Individual
Publication of EP0938278A1 publication Critical patent/EP0938278A1/en
Withdrawn legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95Instruments specially adapted for placement or removal of stents or stent-grafts
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2002/9528Instruments specially adapted for placement or removal of stents or stent-grafts for retrieval of stents

Definitions

  • the present invention relates to an apparatus for placing and recovering parts such as endoprostheses through a biological conduit (artery, vein, biological channel) such as bile duct, urinary canals by being guided by a wire guide previously introduced into the duct , device comprising a sheath intended to be introduced along the wire guide in the pipe to the site of the intervention, the distal end of which is equipped with an intervention tool and the proximal end is provided with a manual control handle connected to the tool by a flexible rod, forming with the flexible sheath, a Bowden cable type connection, for transmitting a relative translational movement.
  • a biological conduit artery, vein, biological channel
  • urinary canals by being guided by a wire guide previously introduced into the duct
  • device comprising a sheath intended to be introduced along the wire guide in the pipe to the site of the intervention, the distal end of which is equipped with an intervention tool and the proximal end is provided with a manual control handle connected to the tool by a flexible rod, forming with the
  • a wire guide is introduced into the femoral artery up to the site of the intervention and this guide is used to set up an endoprotesis such that '' a small tubular element (also called “stent”) in the contracted state and which is deployed inside the artery to eliminate a local narrowing (stenosis).
  • a small tubular element also called “stent”
  • a stent For the installation of a stent, it is fixed on a balloon catheter and on the wire guide and the assembly is pushed to the level of the lesion to be treated (stenosis). When the stent is in place, it is deployed by inflating this balloon until the stent has reached the desired shape, thereby restoring normal section of the artery. But it happens that, as a result of difficulties or incidents at the time of the intervention, this stent is not in its place or is ejected from its location, and it becomes necessary to recover it. However, the wire guide cannot be used to pull this endoprosthesis by simple traction on the wire.
  • the present invention aims to remedy these drawbacks and proposes to create an apparatus allowing the installation and recovery of parts such as endoprostheses through a biological conduit (artery) by being guided by a wire guide beforehand. inserted in the pipe, to properly position this prosthesis and be able to recover it if necessary safely.
  • the invention relates to an apparatus of the type defined above, characterized in that the tool of the distal end comprises: - at least two jaws pivoting, at their rear end, around a hollow joint, this tool s being opened by being pushed by the rod on a stop integral with the distal end of the sheath, housed between the two jaws and against which the jaws lean at the front of their articulation when leaving the sheath,
  • the two jaws have inner jaws forming a cavity to receive a part to be put in place during the intervention and their outer surface is provided with external hooking members.
  • the invention allows intervention at the location to recover a stent without the need to extract the wire guide.
  • the invention uses the wire guide to reach the site of the intervention.
  • this guide not only guides the distal end of the delivery device to the site of the intervention but also into the endoprosthesis. Then simply deploy the tool to hang the stent and extract it by traction.
  • Two cases may arise which are resolved with the device according to the invention: in the first case, the stent is still in the retracted state; following the wire guide, the tool is introduced, not deployed, inside the stent by proceeding for example with a screwing movement or movement of this nature. Once the stent is hooked up, simply pull it out.
  • the second case is that of the stent already deployed.
  • the tool is driven inside the endoprosthesis and deployed to hang its external hooking members in the wall of the endoprosthesis and pull it through the pipe.
  • the control rod is hollow and communicates with the passage of the tool.
  • the hollow rod can be used to provide the intervention site with biological fluids such as a physiological fluid, an anticoagulant, drugs and any fluids necessary for the intervention.
  • biological fluids such as a physiological fluid, an anticoagulant, drugs and any fluids necessary for the intervention.
  • the presence of the wire guide makes it possible to quickly change an accessory, for example a device having a different form of tool without having to remove all of the instrumentation.
  • This hollow rod can also receive the wire guide; in other words, the device is threaded and slid over the wire guide.
  • the tool is connected to an auxiliary sheath forming a branch leaving the sheath behind the tool, this auxiliary sheath communicating with the front through the jaws.
  • the wire guide is outside the sheath of the device and the tube forming the control rod is completely available for the passage of a physiological fluid.
  • FIG. 1 is a view in axial section on a much enlarged scale of the distal end of the delivery device
  • FIG. 1A is a variant of FIG. 1
  • FIG. 2 is a partial view in axial section corresponding to FIG. 1 but showing the tool deployed
  • the invention relates to an apparatus for placing and recovering stents through a biological conduit such as an artery (not shown).
  • This device is guided to the site of the intervention, along a wire guide 1 previously placed in the conduit.
  • the apparatus consists of a sheath 2 introduced into the conduit, along the wire guide 1.
  • the sheath 2 ends at the distal end by a nozzle 3 provided with a transverse stop 4 which bars the opening of the tip 3.
  • the tip is of circular or flat section.
  • the proximal end of the device is not shown; located on the left, according to FIG. 1, at the end of the sheath 2, it is provided with control handles fixed to the sheath 2 and acting on a rod controlling the tool to create a relative translational movement between the sheath and the rod to activate the tool.
  • control handles fixed to the sheath 2 and acting on a rod controlling the tool to create a relative translational movement between the sheath and the rod to activate the tool.
  • the sheath remains stationary and the rod advances and controls the tool; reverse movement is also possible.
  • the tool which will be described below, is connected to the preferably hollow rod 5 fixed in a hollow tip 6 forming part of the tool.
  • This tubular end piece 6 ends with a hollow articulation 7, on which two jaws 8, 9 of the tool pivot by forming a clamp.
  • the tool opens and closes under the effect of its translation relative to the sheath by cooperating with the orifice of the endpiece and the stop guiding the movement of exit and re-entry of the jaws by forcing them to open and close.
  • the shape of the surfaces 81, 91 corresponds to this cylindrical or spherical shape.
  • the jaws Before the articulation 7, the jaws have inner edges 84, 95 to cooperate with the stop 4 and outer edges 85, 95 to cooperate with the edge or edges 31, 32 of the end piece 3.
  • the jaws 8, 9 have internal jaws 82, 92 and external hooking members 83, 93.
  • the internal jaws 82, 92 form a cavity 10 adapted to the shape of the part to be received like the stent 11 (FIG. 2).
  • the cavity 10 may not exist on the jaws whose internal and / or external shape is limited to jaws or hooking means.
  • each jaw 8, 9 is articulated in an elastic manner around a respective articulation 86, 96 represented diagrammatically by a point.
  • This elastic articulation allows the ends of the jaws to be placed parallel to the axis of the tool (represented by the wire guide so as to put the end of the jaws substantially parallel to one another.
  • the tool is shown in Figure 1 in the closed position and in the open position in Figure 2.
  • the clamp In the closed position, the clamp is retracted, that is to say pulled to the left (according to FIG. 1), inside the end piece 3 of the sheath 2.
  • the articulation 7 is crossed by a passage 71 just as the end of the endpiece 6 is provided with a passage 61 in which the front end 51 of the hollow rod 5 is engaged.
  • This hollow rod 5 opens into the passage 71 through an orifice 62 bypassing a branch 12 connected to the part 6.
  • the branch 12 is continued by an auxiliary sheath leaving the sheath 2 which is then the main sheath, by a passage 14 allowing the relative movement of the tool, always controlled by the rod 5 and the main sheath 2, the auxiliary sheath receiving the wire guide 1.
  • the branch 12 and the auxiliary sheath 13 are not necessary when the wire guide passes through the hollow rod 5.
  • FIG. 1A is a figure similar to FIG. 1, with the same references but without the auxiliary sheath 13.
  • the guide cable exits directly from the sheath 2 through the passage 14. Likewise, it leaves the hollow endpiece 6 through a lateral passage 63.
  • the passage 71 of the hollow joint 7 continues through the channel 13 formed between the jaws 8, 9 of the clamp. This channel joins the channel 41 crossing the stop 4 and, finally, the cavity 10 or the gap left between the jaws 8, 9.
  • the endpiece 6, fixed to the end of the control rod 7, is provided with the branch 12 connected to the auxiliary sheath 13 extending to the left to the distal end of the device.
  • This auxiliary sheath is in fact used for the passage of the wire guide 1 which will not pass under these conditions the control tube 5 left free for the passage of physiological fluid.
  • the closing movement of the clamp which is the reverse of the opening movement, is controlled by the sliding support of the cam surfaces 85, 95 from the outside of the jaws 8, 9 against the edges 31, 32 from the mouthpiece.
  • Figures 3, 4, 5 show a variant nozzle according to the invention.
  • the end piece 6A has, as before, a lateral passage 63A. At the front, it ends with two legs 64A, 65A each provided with an orifice 651A, 641A to receive an element of axis 66A, 67A leaving a free interval I for the passage of the wire guide 1.
  • the elements of axis 66A, 67A have exactly the same role of stop as the transverse stop 4 of the previous embodiment.
  • the apparatus according to the invention is designed to place and retrieve parts such as prostheses and more generally foreign bodies in the body, remove prostheses or temporary implants, or implants that are badly placed.

Abstract

The invention concerns an apparatus for setting and removing endoprostheses through a biological duct (artery) guided by a thread guide (1). The apparatus comprises a sheath (2) inserted along the thread guide (1) in the duct to the site of the intervention, whereof the distal end is provided with an instrument and the proximal end with a control handle. The instrument comprises two jaws (8, 9) pivoting, at their rear end, about a recessed articulation (7) and opening, driven by the rod (5) on a limit stop (4) integral with the sheath (2) distal end, between the two jaws (8, 9) resting against it (4). The jaws (8, 9) are traversed by a passage connecting their front part outside the sheath (2) and their rear part to the inside the sheath (2).

Description

« Appareil de pose et de récupération de pièces telles que des endoprothèses »"Device for placing and recovering parts such as stents"
La présente invention concerne un appareil de pose et de récupération de pièces telles que des endoprothè- ses à travers un conduit biologique (artère, veine, canal biologique) tel canal biliaire, canaux urinaires en étant guidé par un guide filaire préalablement introduit dans la conduite, appareil comprenant une gaine destinée à être introduite le long du guide filaire dans la conduite jusqu'au site de l'intervention, dont l'extrémité distale est équipée d'un outil d'intervention et l'extrémité proximale est munie d'une poignée de commande manuelle reliée à l'outil par une tige souple, formant avec la gaine souple, une liaison de type câble Bowden, pour transmettre un mouvement de transla- tion relative.The present invention relates to an apparatus for placing and recovering parts such as endoprostheses through a biological conduit (artery, vein, biological channel) such as bile duct, urinary canals by being guided by a wire guide previously introduced into the duct , device comprising a sheath intended to be introduced along the wire guide in the pipe to the site of the intervention, the distal end of which is equipped with an intervention tool and the proximal end is provided with a manual control handle connected to the tool by a flexible rod, forming with the flexible sheath, a Bowden cable type connection, for transmitting a relative translational movement.
On connaît déjà de tels appareils ou instruments et notamment différents appareils pour des interventions chirurgicales dans le domaine de l'angioplastie.Already known such devices or instruments and in particular different devices for surgical procedures in the field of angioplasty.
En général, pour une telle intervention qui con- siste à intervenir à un emplacement déterminé, on introduit dans l'artère fémorale un guide filaire jusqu'au site de l'intervention et on utilise ce guide pour mettre en place une endoprot èse telle qu'un petit élément tubulaire (encore appelé « stent ») à l'état contracté et que l'on déploie à l'intérieur de l'artère pour en éliminer un rétrécissement local (sténose) .In general, for such an intervention which consists in intervening at a determined location, a wire guide is introduced into the femoral artery up to the site of the intervention and this guide is used to set up an endoprotesis such that '' a small tubular element (also called “stent”) in the contracted state and which is deployed inside the artery to eliminate a local narrowing (stenosis).
Il existe également d'autres interventions de nature analogue dans le corps humain avec mise en place d'une prothèse ou d'un implant en utilisant une conduite biologi- que .There are also other interventions of a similar nature in the human body with the placement of a prosthesis or implant using a biological line.
Pour la mise en place d'une endoprothèse on la fixe sur un cathéter à ballonnet et sur le guide filaire et on pousse l'ensemble jusqu'au niveau de la lésion à traiter (sténose) . Lorsque l' endoprothèse est en place, on la déploie en gonflant ce ballonnet jusqu'à ce que 1 ' endoprothèse ait atteint la forme voulue, rétablissant ainsi la section normale de l'artère. Mais il arrive que, par suite de difficultés ou d'incidents au moment de l'intervention, cette endoprothèse ne soit pas à sa place ou soit éjectée de son emplacement, et qu'il devient nécessaire de la récupérer. Or, le guide filaire ne peut servir à tirer cette endoprothèse par simple traction sur le fil.For the installation of a stent, it is fixed on a balloon catheter and on the wire guide and the assembly is pushed to the level of the lesion to be treated (stenosis). When the stent is in place, it is deployed by inflating this balloon until the stent has reached the desired shape, thereby restoring normal section of the artery. But it happens that, as a result of difficulties or incidents at the time of the intervention, this stent is not in its place or is ejected from its location, and it becomes necessary to recover it. However, the wire guide cannot be used to pull this endoprosthesis by simple traction on the wire.
Pour cela, il faut utiliser un outil spécial permettant de prendre l' endoprothèse .For this, a special tool must be used to take the stent.
Il a déjà été proposé un outil formé d'une gaine recevant une tige dont l'extrémité distale, conduite jusqu'à l'endroit de l' endoprothèse, comporte une boucle déployable.It has already been proposed a tool formed by a sheath receiving a rod whose distal end, led to the location of the stent, comprises a deployable loop.
Mais pour utiliser un tel appareil, il faut enlever le guide filaire. Aussi n'est-il pas facile de conduire l'outil de cet appareil à l'endroit voulu. On le pousse dans l'artère en contrôlant par radioscopie pour enfiler son extrémité dans l' endoprothèse, pour y déployer la boucle et tenter d'accrocher 1 ' endoprothèse .But to use such a device, you must remove the wire guide. So it is not easy to drive the tool of this device to the desired place. It is pushed into the artery by fluoroscopy to thread its end into the stent, to deploy the loop there and try to hook the stent.
Mais la pratique a montré que cet appareil ne pouvait pas fonctionner car la moindre résistance, par frot- tement ou par blocage, détachait l' endoprothèse de l'outil.However, practice has shown that this device cannot function because the slightest resistance, by friction or by blocking, detaches the stent from the tool.
Seule une intervention chirurgicale permet d'enlever l' endoprothèse défectueuse.Only surgery can remove the defective stent.
Il existe d'autres cas où il serait également intéressant de pouvoir extraire une endoprothèse par exemple temporaire ou, plus généralement, une pièce introduite dans une cavité biologique et qui serait accessible à travers un conduit biologique telle qu'une artère, etc..There are other cases where it would also be advantageous to be able to extract a stent, for example temporary or, more generally, a part introduced into a biological cavity and which would be accessible through a biological conduit such as an artery, etc.
La présente invention a pour but de remédier à ces inconvénients et se propose de créer un appareil permet- tant la pose et la récupération de pièces telles que des en- doprothèses à travers un conduit biologique (artère) en étant guidé par un guide filaire préalablement introduit dans la conduite, pour bien positionner cette prothèse et pouvoir la récupérer le cas échéant en toute sécurité. A cet effet, l'invention concerne un appareil du type défini ci-dessus, caractérisé en ce que l'outil de l'extrémité distale comprend : - au moins deux mâchoires pivotant, au niveau de leur extrémité arrière, autour d'une articulation creuse, cet outil s Ouvrant en étant poussé par la tige sur une butée solidaire de l'extrémité distale de la gaine, logée entre les deux mâchoires et contre laquelle s'appuient les mâchoires à l'avant de leur articulation en sortant de la gaine,The present invention aims to remedy these drawbacks and proposes to create an apparatus allowing the installation and recovery of parts such as endoprostheses through a biological conduit (artery) by being guided by a wire guide beforehand. inserted in the pipe, to properly position this prosthesis and be able to recover it if necessary safely. To this end, the invention relates to an apparatus of the type defined above, characterized in that the tool of the distal end comprises: - at least two jaws pivoting, at their rear end, around a hollow joint, this tool s being opened by being pushed by the rod on a stop integral with the distal end of the sheath, housed between the two jaws and against which the jaws lean at the front of their articulation when leaving the sheath,
- les mâchoires se refermant par rétraction de leur extrémité arrière dans la gaine sous l'effet d'une traction exercée par l'intermédiaire de la tige, - les mâchoires étant traversées par un passage reliant leur avant à l'extérieur de la gaine et leur arrière à l'intérieur de la gaine.- the jaws closing by retraction of their rear end in the sheath under the effect of a traction exerted by the intermediary of the rod, - the jaws being crossed by a passage connecting their front to the outside of the sheath and their back inside the sheath.
Les deux mâchoires ont des mors intérieurs formant une cavité pour recevoir une pièce à mettre en place au cours de l'intervention et leur surface extérieure est munie d'organes d'accrochage extérieurs.The two jaws have inner jaws forming a cavity to receive a part to be put in place during the intervention and their outer surface is provided with external hooking members.
L'invention permet d'intervenir à l'emplacement pour y récupérer une endoprothèse sans qu'il soit nécessaire d'extraire le guide filaire. Au contraire, l'invention uti- lise le guide filaire pour atteindre le site de l'intervention. Comme par ailleurs 1 ' endoprothèse est toujours enfilée sur le guide filaire, ce guide assure non seulement le guidage de l'extrémité distale de l'appareil de pose jusqu'au site de l'intervention mais jusque dans l' endoprothèse. Il suffit alors de déployer l'outil pour accrocher l' endoprothèse et extraire celle-ci par traction.The invention allows intervention at the location to recover a stent without the need to extract the wire guide. On the contrary, the invention uses the wire guide to reach the site of the intervention. As also the endoprosthesis is still threaded on the wire guide, this guide not only guides the distal end of the delivery device to the site of the intervention but also into the endoprosthesis. Then simply deploy the tool to hang the stent and extract it by traction.
Deux cas peuvent se présenter qui se résolvent avec l'appareil selon l'invention : dans le premier cas, 1 ' endoprothèse est encore à l'état rétracté ; en suivant le guide filaire, on introduit l'outil, non déployé, à l'intérieur de l' endoprothèse en procédant par exemple à un mouvement de vissage ou mouvement de cette nature. Une fois l' endoprothèse accrochée, il suffit de la tirer.Two cases may arise which are resolved with the device according to the invention: in the first case, the stent is still in the retracted state; following the wire guide, the tool is introduced, not deployed, inside the stent by proceeding for example with a screwing movement or movement of this nature. Once the stent is hooked up, simply pull it out.
Le second cas est celui de l' endoprothèse déjà déployée. On conduit l'outil à l'intérieur de l' endoprothèse et on le déploie pour accrocher ses organes d'accrochage extérieurs dans la paroi de l' endoprothèse et la tirer à travers la conduite. Suivant une caractéristique avantageuse, la tige de commande est creuse et communique avec le passage de l'outil.The second case is that of the stent already deployed. The tool is driven inside the endoprosthesis and deployed to hang its external hooking members in the wall of the endoprosthesis and pull it through the pipe. According to an advantageous characteristic, the control rod is hollow and communicates with the passage of the tool.
La tige creuse peut servir à fournir au site de l'intervention, des fluides biologiques tels qu'un fluide physiologique, un anti-coagulant, des médicaments et tous fluides nécessaires à l'intervention.The hollow rod can be used to provide the intervention site with biological fluids such as a physiological fluid, an anticoagulant, drugs and any fluids necessary for the intervention.
La présence du guide filaire permet de changer rapidement un accessoire, par exemple un appareil ayant une forme d'outil différente sans avoir à retirer l'ensemble de 1 ' instrumentation.The presence of the wire guide makes it possible to quickly change an accessory, for example a device having a different form of tool without having to remove all of the instrumentation.
Cette tige creuse peut également recevoir le guide filaire ; en d'autres termes, l'appareil est enfilé et glissé sur le guide filaire. Suivant une variante, l'outil est relié à une gaine auxiliaire formant un embranchement sortant de la gaine derrière l'outil, cette gaine auxiliaire communiquant avec l'avant à travers les mâchoires.This hollow rod can also receive the wire guide; in other words, the device is threaded and slid over the wire guide. According to a variant, the tool is connected to an auxiliary sheath forming a branch leaving the sheath behind the tool, this auxiliary sheath communicating with the front through the jaws.
Dans ce cas, le guide filaire est à l'extérieur de la gaine de l'appareil et le tube formant la tige de commande est totalement disponible pour le passage d'un fluide physiologique .In this case, the wire guide is outside the sheath of the device and the tube forming the control rod is completely available for the passage of a physiological fluid.
La présente invention sera décrite ci-après de manière plus détaillée à l'aide des dessins annexés d'un exemple de réalisation d'un appareil de pose et de récupération d'une endoprothèse.The present invention will be described below in more detail with the aid of the accompanying drawings of an exemplary embodiment of an apparatus for placing and recovering a stent.
- la figure 1 est une vue en coupe axiale à échelle très agrandie de l'extrémité distale de l'appareil de pose, - la figure 1A est une variante de la figure 1,FIG. 1 is a view in axial section on a much enlarged scale of the distal end of the delivery device, FIG. 1A is a variant of FIG. 1,
- la figure 2 est une vue partielle en coupe axiale correspondant à la figure 1 mais montrant l'outil déployé,FIG. 2 is a partial view in axial section corresponding to FIG. 1 but showing the tool deployed,
- les figures 3, 4, 5 montrent respectivement une vue de côté et une vue de dessus partiellement coupée et une vue de droite d'une variante d'embout selon l'invention.- Figures 3, 4, 5 respectively show a side view and a partially cut top view and a right view of a variant of the nozzle according to the invention.
Selon la figure 1, l'invention concerne un appareil de pose et de récupération d' endoprothèses à travers un conduit biologique telle qu'une artère (non représentée) . Cet appareil est guidé jusqu'au site de l'intervention, le long d'un guide filaire 1 préalablement mis en place dans le conduit . L'appareil se compose d'une gaine 2 introduite dans le conduit, le long du guide filaire 1. La gaine 2 se termine à l'extrémité distale par un embout 3 muni d'une butée transversale 4 qui barre l'ouverture de l'embout 3. Suivant la nature de l'outil, l'embout est de section circulaire ou plate.According to FIG. 1, the invention relates to an apparatus for placing and recovering stents through a biological conduit such as an artery (not shown). This device is guided to the site of the intervention, along a wire guide 1 previously placed in the conduit. The apparatus consists of a sheath 2 introduced into the conduit, along the wire guide 1. The sheath 2 ends at the distal end by a nozzle 3 provided with a transverse stop 4 which bars the opening of the tip 3. Depending on the nature of the tool, the tip is of circular or flat section.
L'extrémité proximale de l'appareil n'est pas représentée ; située à gauche, selon la figure 1, à l'extrémité de la gaine 2, elle est munie de poignées de commande fixées à la gaine 2 et agissant sur une tige commandant 5 l'outil pour créer un mouvement de translation relatif entre la gaine et la tige pour actionner l'outil. Suivant le cas la gaine reste immobile et la tige avance et commande l'outil ; le mouvement inverse est également possible.The proximal end of the device is not shown; located on the left, according to FIG. 1, at the end of the sheath 2, it is provided with control handles fixed to the sheath 2 and acting on a rod controlling the tool to create a relative translational movement between the sheath and the rod to activate the tool. Depending on the case, the sheath remains stationary and the rod advances and controls the tool; reverse movement is also possible.
L'outil, qui sera décrit ci-après, est relié à la tige 5 de préférence creuse fixée dans un embout creux 6 faisant partie de l'outil. Cet embout tubulaire 6 se termine par une articulation 7, creuse, sur laquelle pivotent deux mâchoires 8, 9 de l'outil en formant une pince. L'outil s'ouvre et se ferme sous l'effet de sa translation par rapport à la gaine en coopérant avec l'orifice de l'embout et la butée guidant le mouvement de sortie et de rentrée des mâchoires en les obligeant à s'ouvrir et à se fermer. Ce fonctionnement découpe de la structure de l'outil dont les mâchoires 8, 9 sont terminées à l'arrière par des branches 81, 82 chevau- chant l'articulation creuse 7 de section circulaire d'axe transversal et de forme cylindrique ou sphérique . La forme des surfaces 81, 91 correspond à cette forme cylindrique ou sphérique. Devant l'articulation 7, les mâchoires ont des bords intérieurs 84, 95 pour coopérer avec la butée 4 et des bords extérieurs 85, 95 pour coopérer avec le ou les bords 31, 32 de l'embout 3.The tool, which will be described below, is connected to the preferably hollow rod 5 fixed in a hollow tip 6 forming part of the tool. This tubular end piece 6 ends with a hollow articulation 7, on which two jaws 8, 9 of the tool pivot by forming a clamp. The tool opens and closes under the effect of its translation relative to the sheath by cooperating with the orifice of the endpiece and the stop guiding the movement of exit and re-entry of the jaws by forcing them to open and close. This cutting operation of the structure of the tool, the jaws 8, 9 of which are terminated at the rear by branches 81, 82 overlapping the hollow articulation 7 of circular section of transverse axis and of cylindrical or spherical shape. The shape of the surfaces 81, 91 corresponds to this cylindrical or spherical shape. Before the articulation 7, the jaws have inner edges 84, 95 to cooperate with the stop 4 and outer edges 85, 95 to cooperate with the edge or edges 31, 32 of the end piece 3.
A l'avant, les mâchoires 8, 9 comportent des mors intérieurs 82, 92 et des organes d'accrochage extérieurs 83, 93. Les mors intérieurs 82, 92 forment une cavité 10 adaptée à la forme de la pièce à recevoir comme l' endoprothèse 11 (figure 2) . La cavité 10 peut ne pas exister sur les mâchoires dont la forme intérieure et/ou extérieure se limite à des mors ou des moyens d'accrochage.At the front, the jaws 8, 9 have internal jaws 82, 92 and external hooking members 83, 93. The internal jaws 82, 92 form a cavity 10 adapted to the shape of the part to be received like the stent 11 (FIG. 2). The cavity 10 may not exist on the jaws whose internal and / or external shape is limited to jaws or hooking means.
Selon une variante, l'extrémité de chaque mâchoire 8, 9 est articulée de manière élastique autour d'une articulation 86, 96 respective représentée schématiquement par un point. Cette articulation élastique permet aux extré- mités des mâchoires de se mettre parallèlement à l'axe de l'outil (figuré par le guide filaire de manière à mettre l'extrémité des mâchoires sensiblement parallèles l'une à 1 ' autre .According to a variant, the end of each jaw 8, 9 is articulated in an elastic manner around a respective articulation 86, 96 represented diagrammatically by a point. This elastic articulation allows the ends of the jaws to be placed parallel to the axis of the tool (represented by the wire guide so as to put the end of the jaws substantially parallel to one another.
Cela permet, lorsque l'outil est utilisé pour dé- ployer une endoprothèse que celle-ci soit déployée suivant une forme cylindrique et non conique.This allows, when the tool is used to deploy a stent that it is deployed in a cylindrical shape and not conical.
L'outil est représenté à la figure 1 en position fermée et en position ouverte à la figure 2.The tool is shown in Figure 1 in the closed position and in the open position in Figure 2.
Dans la position fermée, la pince est rétractée, c'est-à-dire tirée vers la gauche (selon la figure 1), à l'intérieur de l'embout 3 de la gaine 2.In the closed position, the clamp is retracted, that is to say pulled to the left (according to FIG. 1), inside the end piece 3 of the sheath 2.
L'articulation 7 est traversée par un passage 71 de même que l'extrémité de l'embout 6 est munie d'un passage 61 dans lequel est engagée l'extrémité avant 51 de la tige creuse 5.The articulation 7 is crossed by a passage 71 just as the end of the endpiece 6 is provided with a passage 61 in which the front end 51 of the hollow rod 5 is engaged.
Cette tige creuse 5 débouche dans le passage 71 par un orifice 62 contournant un embranchement 12 relié à la partie 6. L'embranchement 12 est poursuivi par une gaine auxiliaire sortant de la gaine 2 qui est alors la gaine prin- cipale, par un passage 14 permettant le déplacement relatif de l'outil, toujours commandé par la tige 5 et la gaine principale 2, la gaine auxiliaire recevant le guide filaire 1.This hollow rod 5 opens into the passage 71 through an orifice 62 bypassing a branch 12 connected to the part 6. The branch 12 is continued by an auxiliary sheath leaving the sheath 2 which is then the main sheath, by a passage 14 allowing the relative movement of the tool, always controlled by the rod 5 and the main sheath 2, the auxiliary sheath receiving the wire guide 1.
L'embranchement 12 et la gaine auxiliaire 13 ne sont pas nécessaires lorsque le guide filaire passe dans la tige creuse 5.The branch 12 and the auxiliary sheath 13 are not necessary when the wire guide passes through the hollow rod 5.
La figure 1A est une figure semblable à la figure 1, avec les mêmes références mais sans la gaine auxiliaire 13. Dans ce cas, le câble de guidage sort directement de la gaine 2 par le passage 14. De même, il sort de l'embout creux 6 par un passage 63 latéral.FIG. 1A is a figure similar to FIG. 1, with the same references but without the auxiliary sheath 13. In this case, the guide cable exits directly from the sheath 2 through the passage 14. Likewise, it leaves the hollow endpiece 6 through a lateral passage 63.
A l'avant, du côté tourné par la droite, le passage 71 de l'articulation creuse 7 se poursuit à travers le canal 13 formé entre les mâchoires 8, 9 de la pince. Ce canal rejoint le canal 41 traversant la butée 4 et, enfin, la cavité 10 ou l'intervalle laissé entre les mâchoires 8, 9.At the front, on the side turned to the right, the passage 71 of the hollow joint 7 continues through the channel 13 formed between the jaws 8, 9 of the clamp. This channel joins the channel 41 crossing the stop 4 and, finally, the cavity 10 or the gap left between the jaws 8, 9.
Ces différents passages sont alignés et traversés, comme cela est représenté par le guide filaire 1. Selon l'invention, l'embout 6, fixé à l'extrémité de la tige de commande 7, est muni de l'embranchement 12 raccordé à la gaine auxiliaire 13 se prolongeant vers la gauche jusqu'à l'extrémité distale de l'appareil. Cette gaine auxiliaire sert en fait au passage du guide filaire 1 qui ne tra- versera pas dans ces conditions le tube de commande 5 laissé libre pour le passage de fluide physiologique.These different passages are aligned and crossed, as shown by the wire guide 1. According to the invention, the endpiece 6, fixed to the end of the control rod 7, is provided with the branch 12 connected to the auxiliary sheath 13 extending to the left to the distal end of the device. This auxiliary sheath is in fact used for the passage of the wire guide 1 which will not pass under these conditions the control tube 5 left free for the passage of physiological fluid.
Du fait de la nécessité de faire déboucher l'embranchement 12 sensiblement dans l'axe du support 6, pour arriver sur le passage 71, le passage 61 et sa sortie 62 sont déviés pour contourner cet embranchement .Due to the need to open the branch 12 substantially in the axis of the support 6, to reach the passage 71, the passage 61 and its outlet 62 are deflected to bypass this branch.
Comme le montre la figure 2, lorsque la pince est en position ouverte, ses mâchoires 8, 9 sont écartées. Cette position écartée suppose que les mâchoires 8, 9 ne soient pas articulées (86, 96) ou qu'elles ne rencontrent pas d'obstacle pour s'ouvrir.As shown in Figure 2, when the clamp is in the open position, its jaws 8, 9 are separated. This discarded position assumes that the jaws 8, 9 are not articulated (86, 96) or that they do not encounter any obstacle to open.
Pour arriver dans cette position, en supposant que la gaine 2 reste fixe, on pousse sur la tige de commande 5 dans le sens de la flèche A (figures 1 et 2) à l'aide de la poignée de commande à l'extrémité proximale de l'appareil. Cette poussée, dans la direction A, fait sortir la pince de l'embout 3. Les bords 84, 94 des mâchoires 8, 9 viennent le cas échéant s'appuyer sur la butée 4 qui les force à s'écarter, surtout si un obstacle s'oppose à cet écartement . La pince 8, 9 glisse ainsi en s 'appuyant contre la butée 4 (solidaire de l'embout 3, donc immobile) et s'ouvre en se déplaçant vers la droite (figures 1 et 2) . Ce mouvement se fait par pivotement autour de l'articulation 7 grâce aux surfaces complémentaires 81, 91 de l'extrémité arrière des mâchoires 8, 9 de la pince.To reach this position, assuming that the sheath 2 remains fixed, push on the control rod 5 in the direction of the arrow A (Figures 1 and 2) using the control handle at the proximal end of the device. This thrust, in direction A, brings the clamp out of the nozzle 3. The edges 84, 94 of the jaws 8, 9 come if necessary to bear on the stop 4 which forces them to move apart, especially if a obstacle opposes this spacing. The clamp 8, 9 thus slides while pressing against the stop 4 (secured to the end piece 3, therefore immobile) and opens by moving to the right (Figures 1 and 2). This movement is made by pivoting around the articulation 7 thanks to the surfaces complementary 81, 91 of the rear end of the jaws 8, 9 of the clamp.
L'ouverture représentée à la figure 2 permet de libérer 1 ' endoprothèse 11 transportée jusqu'au site de l'intervention.The opening shown in Figure 2 frees the stent 11 transported to the site of the intervention.
Dans cette situation, l' endoprothèse 11 est encore rétractée.In this situation, the stent 11 is still retracted.
Lorsqu'elle est déployée, elle a une forme beaucoup plus grande correspondant sensiblement au contour exté- rieur de la pince à l'état fermé.When deployed, it has a much larger shape corresponding substantially to the outer contour of the clamp in the closed state.
S'il faut récupérer une endoprothèse 11 ainsi déployée, il suffit de glisser les deux mâchoires de la pince dans 1 ' endoprothèse pour l'accrocher derrière les organes d'accrochage extérieurs 83, 93 et tirer l'ensemble de l'appareil (gaine et tige de commande 2, 5) vers la gauche, dans la direction de la flèche B.If it is necessary to recover an endoprosthesis 11 thus deployed, it suffices to slide the two jaws of the forceps into one endoprosthesis to hang it behind the external hooking members 83, 93 and pull the whole of the device (sheath and control rod 2, 5) to the left, in the direction of arrow B.
Le mouvement de fermeture de la pince, qui est l'inverse du mouvement d'ouverture, est commandé par l'appui glissant des surfaces de cames 85, 95 de l'extérieur des mâ- choires 8, 9 contre les bords 31, 32 de l'embout. Les camesThe closing movement of the clamp, which is the reverse of the opening movement, is controlled by the sliding support of the cam surfaces 85, 95 from the outside of the jaws 8, 9 against the edges 31, 32 from the mouthpiece. The cams
85, 95 sont incurvées pour permettre ce mouvement.85, 95 are curved to allow this movement.
Les figures 3, 4, 5 montrent une variante d'embout selon l'invention.Figures 3, 4, 5 show a variant nozzle according to the invention.
Pour la description de cet embout, on utilisera les mêmes références que pour celle de l'embout des figures 1 et 1A mais avec le suffixe A.For the description of this nozzle, the same references will be used as for that of the nozzle of FIGS. 1 and 1A but with the suffix A.
L'embout 6A comporte comme précédemment un passage latéral 63A. A l'avant, il se termine par deux pattes 64A, 65A munies chacune d'un orifice 651A, 641A pour recevoir un élément d'axe 66A, 67A laissant un intervalle libre I pour le passage du guide filaire 1. Les éléments d'axe 66A, 67A ont exactement le même rôle de butée que la butée transversale 4 du mode de réalisation précédent.The end piece 6A has, as before, a lateral passage 63A. At the front, it ends with two legs 64A, 65A each provided with an orifice 651A, 641A to receive an element of axis 66A, 67A leaving a free interval I for the passage of the wire guide 1. The elements of axis 66A, 67A have exactly the same role of stop as the transverse stop 4 of the previous embodiment.
En résumé, l'appareil selon l'invention est conçu pour placer et récupérer des pièces telles que des prothèses et plus généralement des corps étrangers dans l'organisme, retirer des prothèses ou implants temporaires, ou des implants mal placés. In summary, the apparatus according to the invention is designed to place and retrieve parts such as prostheses and more generally foreign bodies in the body, remove prostheses or temporary implants, or implants that are badly placed.

Claims

R E V E N D I C A T I O N S 1°) Appareil de pose et de récupération de pièces telles que des endoprotheses à travers un conduit biologique (artère) en étant guidé par un guide filaire (1) préalablement introduit dans la conduite, appareil comprenant R E V E N D I C A T I O N S 1 °) Apparatus for placing and recovering parts such as stents through a biological conduit (artery) being guided by a wire guide (1) previously introduced into the conduit, apparatus comprising
- une gaine (2) destinée à être introduite le long du guide filaire (1) dans la conduite jusqu'au site de l'intervention, dont l'extrémité distale est équipée d'un outil d'intervention et l'extrémité proximale est munie d'une poignée de commande manuelle reliée à l'outil par une tige souple, formant avec la gaine souple, une liaison de type câble Bowden, pour transmettre un mouvement de translation relative, appareil caractérisé en ce que 1 ' outil comprend- a sheath (2) intended to be introduced along the wire guide (1) in the pipe to the intervention site, the distal end of which is equipped with an intervention tool and the proximal end is provided with a manual control handle connected to the tool by a flexible rod, forming with the flexible sheath, a Bowden cable type connection, for transmitting a relative translational movement, apparatus characterized in that the tool comprises
- au moins deux mâchoires (8, 9) pivotant, au niveau de leur extrémité arrière, autour d'une articulation creuse (7) , cet outil s 'ouvrant en étant poussé par la tige (5) sur une butée (4) solidaire de l'extrémité distale de la gaine (2), logée entre les deux mâchoires (8, 9) et contre laquelle (4) s'appuient les mâchoires à l'avant de leur articulation (7) en sortant de la gaine (2),- at least two jaws (8, 9) pivoting, at their rear end, around a hollow joint (7), this tool opening by being pushed by the rod (5) on a stop (4) integral from the distal end of the sheath (2), housed between the two jaws (8, 9) and against which (4) the jaws rest at the front of their articulation (7) when leaving the sheath (2 ),
- les mâchoires (8, 9) se refermant par rétraction de leur extrémité arrière dans la gaine (2) sous l'effet d'une traction exercée par l'intermédiaire de la tige (5),- the jaws (8, 9) closing by retraction of their rear end in the sheath (2) under the effect of a traction exerted via the rod (5),
- les mâchoires (8, 9) étant traversées par un passage reliant leur avant à l'extérieur de la gaine (2) et leur arrière à l'intérieur de la gaine (2), les mâchoires (8, 9) ont des organes d'accrochages (82, 92, 83, 93) .- the jaws (8, 9) being traversed by a passage connecting their front outside the sheath (2) and their back inside the sheath (2), the jaws (8, 9) have members clashes (82, 92, 83, 93).
2°) Appareil selon la revendication 1, caractérisé en ce que les mâchoires (8, 9) sont au nombre de deux.2) Apparatus according to claim 1, characterized in that the jaws (8, 9) are two in number.
3°) Appareil selon la revendication 1, caractérisé en ce que les mâchoires (8, 9) ont des mors intérieurs formant une cavité (10) pour recevoir une pièce à poser.3 °) Apparatus according to claim 1, characterized in that the jaws (8, 9) have interior jaws forming a cavity (10) for receiving a part to be placed.
4°) Appareil selon la revendication 1, caractérisé en ce que les mâchoires (8, 9) sont munies d'organes d'accrochage extérieurs (83, 93) .4 °) Apparatus according to claim 1, characterized in that the jaws (8, 9) are provided with external hooking members (83, 93).
5°) Appareil selon la revendication 1, caractérisé en ce que les mâchoires (8, 9) ont une articulation élastique (86, 96) .5 °) Apparatus according to claim 1, characterized in that the jaws (8, 9) have an elastic joint (86, 96).
6°) Appareil selon la revendication 1, caractérisé en ce que la tige de commande (2) est creuse et communique avec le passage de l'outil (61, 71, 13, 41, 10) .6 °) Apparatus according to claim 1, characterized in that the control rod (2) is hollow and communicates with the passage of the tool (61, 71, 13, 41, 10).
7°) Appareil selon la revendication 1, caractérisé en ce que l'outil (6, 7, 8, 9) est relié à une gaine auxiliaire (13) par un embranchement (12) sortant de la gaine (2) derrière les mâchoires (8, 9) , cette gaine auxiliaire (13) communiquant avec l'avant de l'outil à travers les mâchoires (8, 9) .7 °) Apparatus according to claim 1, characterized in that the tool (6, 7, 8, 9) is connected to an auxiliary sheath (13) by a branch (12) emerging from the sheath (2) behind the jaws (8, 9), this auxiliary sheath (13) communicating with the front of the tool through the jaws (8, 9).
8°) Appareil selon la revendication 1, caractérisé en ce que la butée transversale est constituée par deux éléments d'axe8 °) Apparatus according to claim 1, characterized in that the transverse stop consists of two axis elements
(66A, 67A) fixés dans deux prolongements latéraux (64A, 65A) de l'embout (6A) . (66A, 67A) fixed in two lateral extensions (64A, 65A) of the end piece (6A).
EP98933679A 1997-06-25 1998-06-23 Apparatus for setting and removing parts such as endoprostheses Withdrawn EP0938278A1 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
FR9707957 1997-06-25
FR9707957A FR2765098A1 (en) 1997-06-25 1997-06-25 APPLIANCE FOR LAYING AND RECOVERING PARTS SUCH AS ENDOPROTHESES
PCT/FR1998/001307 WO1999000072A1 (en) 1997-06-25 1998-06-23 Apparatus for setting and removing parts such as endoprostheses

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EP0938278A1 true EP0938278A1 (en) 1999-09-01

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AU (1) AU8342098A (en)
CA (1) CA2264648A1 (en)
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WO2005037361A2 (en) * 2003-10-22 2005-04-28 Colin Charles Didcott Dilators and dilator assemblies
US7347868B2 (en) * 2004-10-26 2008-03-25 Baronova, Inc. Medical device delivery catheter
US9532871B2 (en) 2012-05-04 2017-01-03 St. Jude Medical, Cardiology Division, Inc. Delivery system deflection mechanism
US9277990B2 (en) 2012-05-04 2016-03-08 St. Jude Medical, Cardiology Division, Inc. Hypotube shaft with articulation mechanism
WO2014130160A1 (en) * 2013-02-21 2014-08-28 St. Jude Medical, Cardiology Division, Inc. Transapical passive articulation delivery system design
US9566153B2 (en) 2013-09-12 2017-02-14 St. Jude Medical, Cardiology Division, Inc. Alignment of an implantable medical device

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US3416531A (en) * 1964-01-02 1968-12-17 Edwards Miles Lowell Catheter
US5035706A (en) * 1989-10-17 1991-07-30 Cook Incorporated Percutaneous stent and method for retrieval thereof
US5098440A (en) * 1990-08-14 1992-03-24 Cordis Corporation Object retrieval method and apparatus
US5474563A (en) * 1993-03-25 1995-12-12 Myler; Richard Cardiovascular stent and retrieval apparatus

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CA2264648A1 (en) 1999-01-07
AU8342098A (en) 1999-01-19
FR2765098A1 (en) 1998-12-31

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