EP1531735A2 - Device for occluding a hole in a body wall and a unit for inserting said device - Google Patents

Device for occluding a hole in a body wall and a unit for inserting said device

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Publication number
EP1531735A2
EP1531735A2 EP03750855A EP03750855A EP1531735A2 EP 1531735 A2 EP1531735 A2 EP 1531735A2 EP 03750855 A EP03750855 A EP 03750855A EP 03750855 A EP03750855 A EP 03750855A EP 1531735 A2 EP1531735 A2 EP 1531735A2
Authority
EP
European Patent Office
Prior art keywords
disc
body wall
catheter
needle
wall
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Withdrawn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
EP03750855A
Other languages
German (de)
French (fr)
Inventor
Younes Boudjemline
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 EP1531735A2 publication Critical patent/EP1531735A2/en
Withdrawn legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/064—Surgical staples, i.e. penetrating the tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
    • A61B2017/00588—Rigid or stiff implements, e.g. made of several rigid parts linked by hinges
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
    • A61B2017/0061—Implements located only on one side of the opening
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
    • A61B2017/00623—Introducing or retrieving devices therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0419—H-fasteners
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/064—Surgical staples, i.e. penetrating the tissue
    • A61B2017/0649—Coils or spirals

Definitions

  • the present invention relates to a device for occluding an opening existing in a body wall, which can be implanted. by minimally invasive non-surgical route, that is to say by passing through bodily conduits.
  • the invention also relates to an assembly for installing this device.
  • the invention is in particular applicable to the occlusion of septal defects between the right atrium and the left atrium or the right ventricle and the left ventricle of a heart.
  • the document EP 1 046 375 A1 describes a similar device, with two discs connected to each other. These discs have a diameter slightly greater than the diameter of the communication to be treated and are connected by an elastic wire, this wire making it possible, after implantation, to keep the discs pressed against the respective faces of the body wall treated.
  • the present invention aims to provide a device easier to implant than that according to this prior document, less bulky, and more securely held on said body wall.
  • Document WO 01/30267 describes devices for closing or excluding a cavity, comprising an occlusion disc and a structure for anchoring this disc to the body walls forming this cavity.
  • the device according to this document is not suitable for producing the occlusion of an opening or communication existing in a body wall, in particular in the interauricular septum of a heart, by a minimally invasive route.
  • the present invention aims to provide a device for occluding an opening or communication existing in a body wall, overcoming the drawbacks of existing devices.
  • the object of the invention is in particular to provide a space-saving device, the implantation of which is very minimally invasive and which is fixed in a particularly reliable manner to the body wall treated.
  • the device comprises: - a single disc, of diameter greater than the diameter of the opening to be treated, formed by a deformable peripheral wire made of shape memory material and by a flexible wall made of a biocompatible material connected to this wire, this disc being deformable between a normal state of deployment, in which it can be applied against said body wall and come to cover the whole of the opening to be treated, extending beyond the latter, and a state of contraction, in which it can be inserted into a sheath enabling it to be conveyed towards said body wall with a view to its establishment, the disc further comprising means for its removable connection with a rod of manipulation, making it possible to put this disc in place and to keep it applied against said body wall; and
  • the device installation assembly includes:
  • - Said sheath adapted to receive the disc in said state of contraction of this disc and to contain said manipulation rod;
  • At least one catheter containing said hollow needle this needle being of a shape memory material and being deformable between a substantially rectilinear shape, which it takes when it is inserted into the catheter, and a shape in which its portion of the free end is offset laterally relative to its other end portion, the shape which it takes when it is pushed out of the catheter, this offset being such that it allows said free end portion to come opposite the area of said body wall covered by said flexible wall of the disc and to pass through this area when the needle is pushed out of the catheter; and
  • a control rod engaged in the catheter and removably connected to said attachment, making it possible to control the sliding of this attachment through said needle.
  • the disc connected to the manipulation rod, can thus be routed towards the body wall to be treated by means of said sheath then be deployed by withdrawal of this sheath and be pressed against the body wall by means of the manipulation rod.
  • the hollow needle is then pushed out of the catheter which contains it so as to offset its free end portion and then push it through said zone of the body wall covered by the flexible wall of the disc.
  • the fastener is then pushed through the needle by means of said control rod bringing its connection zones into engagement respectively with the disc and with the body wall.
  • This assembly allows the device to be put in place in a very minimally invasive manner, avoiding the use of additional imaging devices and above all allowing the positioning of the needle or needles to be perfectly controlled relative to the disc and therefore relative to the communication to be closed, this positioning being determined by the shape of the needle or needles in the deployed state.
  • Fasteners can be placed over the entire periphery of the disc, so as to hold this disc against the body wall and to achieve a permanent occlusion of the opening that this wall comprises, or one or more fasteners can be put in place on a marginal sector of this periphery, so that the disc does not permanently occlude the opening to be treated and can function like a valve.
  • This second mode of implantation can be extremely interesting in patients with pulmonary arterial hypertension.
  • the means for the removable connection of the disc with the handling rod may comprise a radial wire integral with said peripheral wire of the disc, comprising, at the center of the disc, a threaded sleeve, said manipulation rod comprising a threaded end which can be screwed into this socket.
  • the flexible wall of the disc can be made of PTFE (polytetrafluoroetylene) or pericardium, and the peripheral wire can be made of a nickel-titanium alloy known under the name "nitinol”.
  • Said connecting zones which each fastener comprises may be in the form of two deployable distant bearing surfaces, separated from each other by a tapered intermediate portion of length corresponding substantially to the added thickness of said body wall and said flexible wall of the disc, one of said support surfaces of the fastener being intended to bear against said flexible wall of the disc and the other support surface of this fastener being intended to bear against said body wall, side of this wall opposite the disc, said tapered intermediate portion being intended to pass through said body wall.
  • the bearing surfaces that the fastener comprises may be in the form of spirals formed by a wire constituting the fastener, or in the form of branches or radial fins.
  • This fastener can also be made of a nickel-titanium alloy known by the name "nitinol”.
  • the catheter can be integral with the manipulation rod, or can slide along the latter.
  • the manipulation rod comprises a stop allowing the catheter to be positioned axially with respect to the disc so as to achieve the adequate offset of said free end portion of the needle.
  • the axial position of the catheter relative to the manipulation rod, therefore relative to the disc, at the time of deployment of the needle is precisely determined, either by the connection from this catheter to the manipulation rod, either by said stop.
  • This position has been determined as a function of the shape of the needle in the deployed state, and makes it possible to perfectly control the positioning of the needle relative to the disc and therefore relative to the communication to be closed.
  • the sliding mounting of the catheter relative to the manipulation rod has the advantage of reducing the size of the vascular access required, each element of the occlusion device being brought one after the other at the implantation site.
  • the catheter can also be pivotally mounted around the manipulation rod.
  • a single catheter can then be used for the placement of several attachments at different locations on the periphery of the disc, by pivoting the catheter around the manipulation rod.
  • the catheter and the manipulation rod can then respectively comprise a mark and a graduation making it possible to position the catheter angularly with respect to the manipulation rod.
  • the assembly according to the invention may also include several catheters arranged angularly according to the different implantations of the fasteners to be produced.
  • the needle can also be made of a nickel-titanium alloy known by the name "nitinol”.
  • the removable connection means the control rod and the fastener can also be in the form of a threaded socket and of threaded end that can be screwed into this socket.
  • Figures 1 and 2 are views, respectively in plan and side, of a disc that includes this device;
  • Figures 3a to 3c are perspective views of three embodiments of a fastener that includes the device;
  • Figure 4 is a side view of a handling rod that includes said assembly;
  • FIGS. 5a to 5e and 6a to 6e are views, respectively at the end and from the side, of different variants of a guide sheath and of catheters that said assembly comprises;
  • Figure 7 is a side view of a hollow needle that includes this assembly;
  • Figure 8 is an enlarged view of the free end of this needle;
  • Figures 9 to 15 are views of different successive stages of positioning the device on a right atrium of a heart;
  • FIG. 16a and 16b are end views of two variants of another guide sheath and of catheters that said assembly comprises, and Figures 17 and 18 are side views of a disc that the device comprises, after implantation by means of the sheath and catheters according to one of Figures 16a or 16b, in two operating positions.
  • Figures 1 and 2 show a disc 1 allowing, as shown in Figure 15, to occlude an opening or communication 2 that comprises a body wall 3, in this case the interauricular septum of a heart.
  • the disc 1 comprises a flexible wall 5 made of PTFE (polytetrafluoroethylene) connected to a peripheral wire 6 made of nickel-titanium alloy known under the name "nitinol”, and a radial wire 7 comprising, at the center of the disc 1, a threaded socket 8, axially oriented.
  • PTFE polytetrafluoroethylene
  • the disc 1 has a diameter greater than the diameter of the opening 2 to be treated.
  • This disc 1 can be deformed in order to be able to be engaged in a sheath 10 allowing its routing to the implantation site, by using a vascular duct 11, as shown in FIG. 9.
  • the disc 1 is fixed to the body wall 3 by means of fasteners 15, more particularly visible in FIGS. 3a to 3c.
  • Each fastener 15 comprises two deployable remote bearing surfaces 16, separated from each other by a tapered intermediate portion 17 of length corresponding substantially to the added thickness of the body wall 3 and the wall 5 of the disc 1.
  • Each fastener 15 is made of "nitinol" and can be deformed so as to be able to be engaged in a hollow needle 28 described below.
  • the bearing surfaces In the case of the fastener 15 shown in FIG. 3a, the bearing surfaces
  • each fastener 15 further comprises a threaded socket 18 which allows its removable connection with a control rod 20, visible in Figures 13 and 14, the latter having a corresponding threaded end.
  • the implantation of the disc 1 is carried out by means of an assembly comprising, in addition to the aforementioned sheath 10, the manipulation rod 25 shown in FIG. 4, the guide sheath 26 and the catheter (s) 27 shown in FIGS. 5a to 6th, and one or more needles 28, one of which is shown in FIG. 7.
  • These rod 25, sheath 26 and catheters 27 have lengths such that they can be manipulated from outside the patient's body when the disc 1 is level with the wall 3, and have flexibilities allowing them to cross the elbows that can form the vascular duct 11 used for their introduction.
  • the handling rod 25 comprises a threaded end 30 which can be screwed into the socket 8 and thus ensure a removable connection of the disc 1 to it, and comprises a stop 31 secured to it, located in a determined location, explained below.
  • the guide sheath 26 has a diameter such that it can be slidably engaged on the rod 25 until it comes against the stop 31. It can comprise from one to six catheters 27, the latter being regularly distributed around its periphery.
  • Each catheter 27 is connected to the sheath 26 and can slidingly receive a needle 28.
  • Each catheter 27 has a proximal tip 32 allowing it to be connected to a syringe for injecting an appropriate liquid, so that its light can be purged for avoid embolism.
  • Each needle 28 is made of a nickel-titanium alloy known under the name "nitinol”, and is deformable between a substantially rectilinear shape, which it takes when it is inserted into the catheter 27, and the deflected shape shown in FIG. 7, that it takes when it is pushed out of the catheter 27.
  • this deflected form it has a double curvature dividing it into a free end portion 28a, an oblique intermediate portion 28b and its other end portion 28c, said free end portion 28a being offset laterally relative to this other end portion 28c. This offset is such that it allows said free end portion 28a to come opposite the zone of the body wall 3 covered by the wall 5 of the disc 1 and to pass through this zone when the needle 28 is pushed further out of the catheter 27, as shown in FIGS. 12 and 13.
  • the needle 28 is bevelled at its free end, as shown in FIG. 8, to facilitate its penetration through the walls 3 and 5, and is connected by its other end to a catheter 35 opening onto the outside of the patient, this catheter capable of slidingly receiving a clip 15 connected to a control rod 20.
  • the disk 1 connected to the rod 25 is routed to the wall 3, this disk and this rod being contained in the sheath 10, which keeps the disk in the contracted state (FIG. 9), through the opening 2; the sheath 10 is then removed to allow the deployment of the disc 1 (FIG. 10), then the guide sheath 26 is engaged on the rod 25 until it comes against the stop 31, and the needles 28 and catheter 35 are engaged in the catheters 27 ( Figure 11); the needles 28 are then partially pushed out of the catheters 27 so as to carry out the abovementioned offset from their free ends 28a (left needle in FIG. 12) then their insertion through the walls 3 and 5 (right needle in FIG.
  • Figures 16a and 16b show that the sheath 26 may include catheters 27 only on a marginal sector of its periphery; fasteners 15 can be put in place using the assembly comprising such a sheath and such catheters as on a corresponding marginal sector of the disc 1, so that this disc 1 does not achieve permanent occlusion of the opening 2 to be treated and can operate in the manner of a valve, as shown in FIGS. 17 and 18.
  • This second embodiment can be extremely interesting in patients with pulmonary arterial hypertension.
  • the invention thus provides a device for occluding an opening existing in a body wall, which can be implanted by a minimally invasive route, that is to say by passing through bodily conduits, and having the determining advantages of being little bulky, relatively easy to implant and securely held on said body wall.
  • the invention also provides a set of installation of this device allowing a positioning of the device in a very minimally invasive manner, by avoiding the use of additional imaging devices and above all by allowing to perfectly control the positioning of the or needles in relation to the disc and therefore in relation to the communication to be closed.
  • the catheter (s) 27 may be integral with the manipulation rod 25, the axial position of this or these catheters relative to this rod being then determined by the connection of this or these catheters to this rod, instead of the stop 31.
  • the needle 28 can be through at its distal end, as shown in FIGS. 7 and 8, or can comprise a lateral slit at this distal end and be equipped with a removable means for concealing the this slot.
  • This removable means can in particular be a flexible tube sliding in the needle. The fastener 15 is then deployed through this lateral slot, the latter being concealed by retraction of the sliding tube.
  • the distal end of the needle may, in this case, be full, forming a dead end.
  • the fastener may have, in particular for use with a needle comprising such a lateral slit, the shape of a staple, that is to say comprise two end branches, forming said connecting zones, and an intermediate branch , said end branches coming, in the deployed state of the fastener, in a position perpendicular to the intermediate branch.

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  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medical Informatics (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Veterinary Medicine (AREA)
  • Molecular Biology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Cardiology (AREA)
  • Surgical Instruments (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Prostheses (AREA)

Abstract

The inventive device comprises a solid disk (1) whose diameter is larger than the diameter of a hole (2) to be treated and which is formed by a peripheral deformable thread (6) made of a shape memory material and a flexible membrane (6) which is made of biocompatible material and connected to said thread; and at least an attachment (15) separated from the disk (1) which makes it possible to fix said disk (1) to the body wall. Each attachment (15) is provided with an area (16) for linking to the disk and an area (16) for linking to the body wall (3) and is embodied such that it is deformable and can be introduced into a hollow needle (28). -

Description

DISPOSITIF D'OCCLUSION D'UNE OUVERTURE EXISTANT DANS UNE PAROI CORPORELLE, IMPLANTABLE PAR VOIE MINI-INVASIVE, ET ENSEMBLE DE MISE EN PLACE DE CE DISPOSITIF La présente invention concerne un dispositif d'occlusion d'une ouverture existant dans une paroi corporelle, implantable par voie mini-invasive non chirurgicale, c'est-à-dire en passant par des conduits corporels. L'invention concerne également un ensemble de mise en place de ce dispositif. The present invention relates to a device for occluding an opening existing in a body wall, which can be implanted. by minimally invasive non-surgical route, that is to say by passing through bodily conduits. The invention also relates to an assembly for installing this device.
L'invention est en particulier applicable à l'occlusion de défauts septaux entre l'oreillette droite et l'oreillette gauche ou le ventricule droit et le ventricule gauche d'un cœur.The invention is in particular applicable to the occlusion of septal defects between the right atrium and the left atrium or the right ventricle and the left ventricle of a heart.
La fermeture de tels défauts septaux se fait habituellement par intervention chirurgicale ou par utilisation d'un cathéter cardiaque passant à travers les vaisseaux, dans lequel sont placés des dispositifs d'occlusion déployables. Le document US 5 846 261 A décrit un de ces dispositifs, formé par deux disques volumineux et rigides, plus larges que la communication à fermer, et par une partie interdisque de la taille de la communication à obturer. L'implantation est visualisée grâce à des rayons X sur des écrans d'imagerie bidimensionnelle. Le dispositif est chargé dans le cathéter puis est avancé dans l'oreillette gauche à travers la communication interauriculaire ; le premier disque est alors sorti du cathéter et est appliqué sur le septum interauriculaire, réalisant ainsi une occlusion de la communication ; le deuxième disque est ensuite sorti du cathéter et vient prendre en sandwich le septum interauriculaire fermant la communication. Bien que simple, l'utilisation de tels dispositifs est limitée au traitement d'ouvertures ou de communications présentes dans des parois tissulaires ayant une certaine épaisseur de berge, égale ou supérieure à 7 millimètres, et n'excédant pas une certaine taille. De plus, la rigidité du dispositif décrit par le document antérieur le rend inutilisable chez le petit enfant. II en résulte que de nombreuses communications interauriculaires sont fermées par voie chirurgicale, avec contrôle direct de la communication à traiter. Cette chirurgie nécessite une ouverture du thorax et la mise en œuvre d'une circulation extracorporelle pour vider le sang du cœur et permettre la suture du défaut septal. En cas de communication de grande taille, un patch de péricarde ou de PTFE est nécessaire pour l'occlusion.The closure of such septal defects is usually accomplished by surgery or by the use of a cardiac catheter passing through the vessels, in which deployable occlusion devices are placed. Document US 5,846,261 A describes one of these devices, formed by two bulky and rigid disks, wider than the communication to be closed, and by an interdisc portion of the size of the communication to be closed. The implantation is visualized using X-rays on two-dimensional imaging screens. The device is loaded into the catheter and then advanced into the left atrium through the atrial communication; the first disc is then taken out of the catheter and is applied to the interatrial septum, thereby occluding the communication; the second disc is then taken out of the catheter and sandwiches the interauricular septum closing the communication. Although simple, the use of such devices is limited to the treatment of openings or communications present in tissue walls having a certain bank thickness, equal to or greater than 7 millimeters, and not exceeding a certain size. In addition, the rigidity of the device described by the previous document makes it unusable in small children. As a result, many interauricular communications are closed surgically, with direct control of the communication to be treated. This surgery requires an opening of the chest and the implementation of an extracorporeal circulation to empty the blood from the heart and allow the suturing of the septal defect. In case of large communication, a pericardium or PTFE patch is necessary for occlusion.
Le document EP 1 046 375 A1 décrit un dispositif similaire, à deux disques reliés l'un à l'autre. Ces disques ont un diamètre légèrement supérieur au diamètre de la communication à traiter et sont reliés par un fil élastique, ce fil permettant, après implantation, de maintenir les disques plaqués contre les faces respectives de la paroi corporelle traitée.The document EP 1 046 375 A1 describes a similar device, with two discs connected to each other. These discs have a diameter slightly greater than the diameter of the communication to be treated and are connected by an elastic wire, this wire making it possible, after implantation, to keep the discs pressed against the respective faces of the body wall treated.
La présente invention vise à fournir un dispositif plus facile à implanter que celui selon ce document antérieur, moins encombrant, et maintenu de façon plus sûre sur ladite paroi corporelle.The present invention aims to provide a device easier to implant than that according to this prior document, less bulky, and more securely held on said body wall.
Le document WO 01/30267 décrit des dispositifs de fermeture ou d'exclusion d'une cavité, comprenant un disque d'occlusion et une structure d'ancrage de ce disque aux parois corporelles formant cette cavité.Document WO 01/30267 describes devices for closing or excluding a cavity, comprising an occlusion disc and a structure for anchoring this disc to the body walls forming this cavity.
Le dispositif selon ce document n'est pas adapté à la réalisation de l'occlusion d'une ouverture ou communication existant dans une paroi corporelle, en particulier dans le septum interauriculaire d'un cœur, par voie très peu invasive.The device according to this document is not suitable for producing the occlusion of an opening or communication existing in a body wall, in particular in the interauricular septum of a heart, by a minimally invasive route.
La présente invention vise à fournir un dispositif permettant de réaliser l'occlusion d'une ouverture ou communication existant dans une paroi corporelle, en remédiant aux inconvénients des dispositifs existants. Le but de l'invention est en particulier de fournir un dispositif peu encombrant, dont l'implantation est très peu invasive et qui est fixé de manière particulièrement fiable à la paroi corporelle traitée.The present invention aims to provide a device for occluding an opening or communication existing in a body wall, overcoming the drawbacks of existing devices. The object of the invention is in particular to provide a space-saving device, the implantation of which is very minimally invasive and which is fixed in a particularly reliable manner to the body wall treated.
Selon l'invention, le dispositif comprend : - un disque unique, de diamètre supérieur au diamètre de l'ouverture à traiter, formé par un fil périphérique deformable en matériau à mémoire de forme et par une paroi souple en un matériau biocompatible reliée à ce fil, ce disque étant deformable entre un état normal de déploiement, dans lequel il peut être appliqué contre ladite paroi corporelle et venir recouvrir l'ensemble de l'ouverture à traiter, en s'étendant au-delà de celle-ci, et un état de contraction, dans lequel il peut être inséré dans une gaine permettant de l'acheminer vers ladite paroi corporelle en vue de sa mise en place, le disque comportant en outre des moyens pour sa liaison amovible avec une tige de manipulation, permettant de mettre ce disque en place et de le maintenir appliqué contre ladite paroi corporelle ; etAccording to the invention, the device comprises: - a single disc, of diameter greater than the diameter of the opening to be treated, formed by a deformable peripheral wire made of shape memory material and by a flexible wall made of a biocompatible material connected to this wire, this disc being deformable between a normal state of deployment, in which it can be applied against said body wall and come to cover the whole of the opening to be treated, extending beyond the latter, and a state of contraction, in which it can be inserted into a sheath enabling it to be conveyed towards said body wall with a view to its establishment, the disc further comprising means for its removable connection with a rod of manipulation, making it possible to put this disc in place and to keep it applied against said body wall; and
- au moins une attache séparée du disque, permettant la fixation de ce disque à ladite paroi corporelle, chaque attache comprenant une zone de liaison au disque et une zone de liaison à la paroi corporelle et pouvant être déformée de manière à pouvoir être engagée dans une aiguille creuse. L'ensemble de mise en place du dispositif comprend :- At least one separate attachment of the disc, allowing the attachment of this disc to said body wall, each attachment comprising a zone of connection to the disc and a zone of connection to the body wall and which can be deformed so as to be able to be engaged in a hollow needle. The device installation assembly includes:
- ladite gaine, propre à recevoir le disque dans ledit état de contraction de ce disque et à contenir ladite tige de manipulation ; - au moins un cathéter contenant ladite aiguille creuse, cette aiguille étant en un matériau à mémoire de forme et étant deformable entre une forme sensiblement rectiligne, qu'elle prend lorsqu'elle est insérée dans le cathéter, et une forme dans laquelle sa portion d'extrémité libre est déportée latéralement par rapport à son autre portion d'extrémité, forme qu'elle prend lorsqu'elle est poussée hors du cathéter, ce déport étant tel qu'il permet à ladite portion d'extrémité libre de venir en regard de la zone de ladite paroi corporelle recouverte par ladite paroi souple du disque et de traverser cette zone lorsque l'aiguille est poussée hors du cathéter ; et- Said sheath, adapted to receive the disc in said state of contraction of this disc and to contain said manipulation rod; - At least one catheter containing said hollow needle, this needle being of a shape memory material and being deformable between a substantially rectilinear shape, which it takes when it is inserted into the catheter, and a shape in which its portion of the free end is offset laterally relative to its other end portion, the shape which it takes when it is pushed out of the catheter, this offset being such that it allows said free end portion to come opposite the area of said body wall covered by said flexible wall of the disc and to pass through this area when the needle is pushed out of the catheter; and
- une tige de commande, engagée dans le cathéter et reliée de manière amovible à ladite attache, permettant de commander le coulissement de cette attache à travers ladite aiguille.- A control rod, engaged in the catheter and removably connected to said attachment, making it possible to control the sliding of this attachment through said needle.
Le disque, relié à la tige de manipulation, peut ainsi être acheminé vers la paroi corporelle à traiter au moyen de ladite gaine puis être déployé par retrait de cette gaine et être plaqué contre la paroi corporelle au moyen de la tige de manipulation. L'aiguille creuse est alors poussée hors du cathéter qui la contient de manière à réaliser le déport de sa portion d'extrémité libre puis son enfoncement à travers ladite zone de la paroi corporelle recouverte par la paroi souple du disque. L'attache est alors poussée au travers de l'aiguille au moyen de ladite tige de commande amener ses zones de liaisons en prise respectivement avec le disque et avec la paroi corporelle.The disc, connected to the manipulation rod, can thus be routed towards the body wall to be treated by means of said sheath then be deployed by withdrawal of this sheath and be pressed against the body wall by means of the manipulation rod. The hollow needle is then pushed out of the catheter which contains it so as to offset its free end portion and then push it through said zone of the body wall covered by the flexible wall of the disc. The fastener is then pushed through the needle by means of said control rod bringing its connection zones into engagement respectively with the disc and with the body wall.
Une ou plusieurs attaches sont mises en place puis les tiges de commande et de manipulation sont retirées. Cet ensemble selon l'invention permet une mise en place du dispositif de manière très peu invasive, en évitant le recours à des appareils annexes d'imagerie et surtout en permettant de maîtriser parfaitement le positionnement de la ou des aiguilles par rapport au disque et donc par rapport à la communication à fermer, ce positionnement étant déterminé par la forme de la ou des aiguilles à l'état déployé.One or more fasteners are put in place, then the control and handling rods are removed. This assembly according to the invention allows the device to be put in place in a very minimally invasive manner, avoiding the use of additional imaging devices and above all allowing the positioning of the needle or needles to be perfectly controlled relative to the disc and therefore relative to the communication to be closed, this positioning being determined by the shape of the needle or needles in the deployed state.
Des attaches peuvent être mises en place sur l'ensemble de la périphérie du disque, de manière à maintenir ce disque contre la paroi corporelle et à réaliser une occlusion permanente de l'ouverture que comprend cette paroi, ou une ou plusieurs attaches peuvent être mises en place sur un secteur marginal de cette périphérie, de manière à ce que le disque ne réalise pas une occlusion permanente de l'ouverture à traiter et puisse fonctionner à la manière d'un clapet. Ce deuxième mode d'implantation peut être extrêmement intéressant chez les patients ayant une hypertension artérielle pulmonaire.Fasteners can be placed over the entire periphery of the disc, so as to hold this disc against the body wall and to achieve a permanent occlusion of the opening that this wall comprises, or one or more fasteners can be put in place on a marginal sector of this periphery, so that the disc does not permanently occlude the opening to be treated and can function like a valve. This second mode of implantation can be extremely interesting in patients with pulmonary arterial hypertension.
Les moyens pour la liaison amovible du disque avec la tige de manipulation peuvent comprendre un fil radial solidaire dudit fil périphérique du disque, comportant, au niveau du centre du disque, une douille taraudée, ladite tige de manipulation comprenant une extrémité filetée pouvant être vissée dans cette douille.The means for the removable connection of the disc with the handling rod may comprise a radial wire integral with said peripheral wire of the disc, comprising, at the center of the disc, a threaded sleeve, said manipulation rod comprising a threaded end which can be screwed into this socket.
La paroi souple du disque peut être en PTFE (polytétrafluoroétylène) ou en péricarde, et le fil périphérique peut être en alliage nickel-titane connu sous la dénomination "nitinol".The flexible wall of the disc can be made of PTFE (polytetrafluoroetylene) or pericardium, and the peripheral wire can be made of a nickel-titanium alloy known under the name "nitinol".
Lesdites zones de liaison que comprend chaque attache peuvent être sous forme de deux surfaces d'appui distantes déployables, séparées l'une de l'autre par une portion intermédiaire effilée de longueur correspondant sensiblement à l'épaisseur additionnée de ladite paroi corporelle et de ladite paroi souple du disque, l'une desdites surfaces d'appui de l'attache étant destinée à prendre appui contre ladite paroi souple du disque et l'autre surface d'appui de cette attache étant destinée à prendre appui contre ladite paroi corporelle, du côté de cette paroi opposé au disque, ladite portion intermédiaire effilée étant destinée à traverser ladite paroi corporelle. Lors de la mise en place d'une attache, après que l'aiguille ait été engagée au travers de la paroi corporelle et au travers du disque, l'attache est poussée pour extraire l'une de ses surfaces d'appui hors de l'aiguille et déployer cette surface, puis l'aiguille est reculée pour extraire ladite portion intermédiaire effilée et l'autre surface d'appui de l'attache de telle sorte que cette autre surface d'appui vienne prendre appui contre la paroi corporelle du côté opposé à celui contre lequel ce trouve le disque.Said connecting zones which each fastener comprises may be in the form of two deployable distant bearing surfaces, separated from each other by a tapered intermediate portion of length corresponding substantially to the added thickness of said body wall and said flexible wall of the disc, one of said support surfaces of the fastener being intended to bear against said flexible wall of the disc and the other support surface of this fastener being intended to bear against said body wall, side of this wall opposite the disc, said tapered intermediate portion being intended to pass through said body wall. When fitting a clip, after the needle has been engaged through the body wall and through the disc, the clip is pushed to extract one of its bearing surfaces from the needle and deploy this surface, then the needle is moved back to extract said tapered intermediate portion and the other bearing surface of the fastener so that this other bearing surface comes to bear against the body wall on the side opposite to that against which this disc finds.
Les surfaces d'appui que comprend l'attache peuvent être sous forme de spirales formées par un fil constituant l'attache, ou sous forme de branches ou d'ailettes radiales.The bearing surfaces that the fastener comprises may be in the form of spirals formed by a wire constituting the fastener, or in the form of branches or radial fins.
Cette attache peut également être en alliage nickel-titane connu sous la dénomination "nitinol".This fastener can also be made of a nickel-titanium alloy known by the name "nitinol".
Le cathéter peut être solidaire de la tige de manipulation, ou peut coulisser le long de celle-ci. Dans ce deuxième cas, la tige de manipulation comprend une butée permettant de positionner axialement le cathéter par rapport au disque de manière à réaliser le déport adéquat de ladite portion d'extrémité libre de l'aiguille.The catheter can be integral with the manipulation rod, or can slide along the latter. In this second case, the manipulation rod comprises a stop allowing the catheter to be positioned axially with respect to the disc so as to achieve the adequate offset of said free end portion of the needle.
Dans l'un ou l'autre de ces cas, la position axiale qu'a le cathéter par rapport à la tige de manipulation, donc par rapport au disque, au moment du déploiement de l'aiguille est précisément déterminée, soit par la liaison de ce cathéter à la tige de manipulation, soit par ladite butée. Cette position a été déterminée en fonction de la forme qu'a l'aiguille à l'état déployé, et permet de maîtriser parfaitement le positionnement de l'aiguille par rapport au disque et donc par rapport à la communication à fermer. Le montage coulissant du cathéter par rapport à la tige de manipulation a pour avantage de réduire la taille de l'accès vasculaire nécessaire, chaque élément du dispositif d'occlusion étant amené l'un après l'autre au niveau du site d'implantation.In either of these cases, the axial position of the catheter relative to the manipulation rod, therefore relative to the disc, at the time of deployment of the needle is precisely determined, either by the connection from this catheter to the manipulation rod, either by said stop. This position has been determined as a function of the shape of the needle in the deployed state, and makes it possible to perfectly control the positioning of the needle relative to the disc and therefore relative to the communication to be closed. The sliding mounting of the catheter relative to the manipulation rod has the advantage of reducing the size of the vascular access required, each element of the occlusion device being brought one after the other at the implantation site.
Le cathéter peut par ailleurs être monté pivotant autour de la tige de manipulation. Un même cathéter peut alors être utilisé pour la mise en place de plusieurs attaches en différents emplacements de la périphérie du disque, par pivotement du cathéter autour de la tige de manipulation. Le cathéter et la tige de manipulation peuvent alors comprendre respectivement un repère et une graduation permettant de positionner angulairement le cathéter par rapport à la tige de manipulation.The catheter can also be pivotally mounted around the manipulation rod. A single catheter can then be used for the placement of several attachments at different locations on the periphery of the disc, by pivoting the catheter around the manipulation rod. The catheter and the manipulation rod can then respectively comprise a mark and a graduation making it possible to position the catheter angularly with respect to the manipulation rod.
L'ensemble selon l'invention peut également comprendre plusieurs cathéters disposés angulairement selon les différentes implantations des attaches à réaliser.The assembly according to the invention may also include several catheters arranged angularly according to the different implantations of the fasteners to be produced.
L'aiguille peut aussi être en alliage nickel-titane connu sous la dénomination "nitinol".The needle can also be made of a nickel-titanium alloy known by the name "nitinol".
Les moyens de liaison amovible la tige de commande et de l'attache peuvent également être sous forme de douille taraudée et d'extrémité filetée pouvant être vissée dans cette douille.The removable connection means the control rod and the fastener can also be in the form of a threaded socket and of threaded end that can be screwed into this socket.
L'invention sera bien comprise, et d'autres caractéristiques et avantages de celle-ci apparaîtront, en référence au dessin schématique annexé, représentant, à titre d'exemples non limitatifs, plusieurs formes de réalisation possibles du dispositif qu'elle concerne et d'un ensemble de mise en place de ce dispositif.The invention will be clearly understood, and other characteristics and advantages thereof will appear, with reference to the appended schematic drawing, representing, by way of nonlimiting examples, several possible embodiments of the device which it relates to and d 'a set of implementation of this device.
Les figures 1 et 2 sont des vues, respectivement en plan et de côté, d'un disque que comprend ce dispositif ; les figures 3a à 3c sont des vues en perspective de trois formes de réalisation d'une attache que comprend le dispositif ; la figure 4 est une vue de côté d'une tige de manipulation que comprend ledit ensemble ; les figures 5a à 5e et 6a à 6e sont des vues, respectivement en bout et de côté, de différentes variantes d'une gaine de guidage et de cathéters que comprend ledit ensemble ; la figure 7 est une vue de côté d'une aiguille creuse que comprend cet ensemble ; la figure 8 est une vue agrandie de l'extrémité libre de cette aiguille ; les figures 9 à 15 sont des vues de différentes étapes successives de mise en place du dispositif sur une oreillette droite d'un cœur ; les figures 16a et 16b sont des vues en bout de deux variantes d'une autre gaine de guidage et de cathéters que comprend ledit ensemble, et les figures 17 et 18 sont des vues de côté d'un disque que comprend le dispositif, après implantation au moyen de la gaine et des cathéters selon l'une des figures 16a ou 16b, dans deux positions de fonctionnement.Figures 1 and 2 are views, respectively in plan and side, of a disc that includes this device; Figures 3a to 3c are perspective views of three embodiments of a fastener that includes the device; Figure 4 is a side view of a handling rod that includes said assembly; FIGS. 5a to 5e and 6a to 6e are views, respectively at the end and from the side, of different variants of a guide sheath and of catheters that said assembly comprises; Figure 7 is a side view of a hollow needle that includes this assembly; Figure 8 is an enlarged view of the free end of this needle; Figures 9 to 15 are views of different successive stages of positioning the device on a right atrium of a heart; FIGS. 16a and 16b are end views of two variants of another guide sheath and of catheters that said assembly comprises, and Figures 17 and 18 are side views of a disc that the device comprises, after implantation by means of the sheath and catheters according to one of Figures 16a or 16b, in two operating positions.
Les figures 1 et 2 représentent un disque 1 permettant, ainsi que le montre la figure 15, de réaliser l'occlusion d'une ouverture ou communication 2 que comprend une paroi corporelle 3, en l'occurrence le septum interauriculaire d'un cœur.Figures 1 and 2 show a disc 1 allowing, as shown in Figure 15, to occlude an opening or communication 2 that comprises a body wall 3, in this case the interauricular septum of a heart.
Le disque 1 comprend une paroi souple 5 en PTFE (polytétrafluoroéthylène) reliée à un fil périphérique 6 en alliage nickel-titane connu sous la dénomination "nitinol", et un fil radial 7 comportant, au niveau du centre du disque 1 , une douille taraudée 8, orientée axialement.The disc 1 comprises a flexible wall 5 made of PTFE (polytetrafluoroethylene) connected to a peripheral wire 6 made of nickel-titanium alloy known under the name "nitinol", and a radial wire 7 comprising, at the center of the disc 1, a threaded socket 8, axially oriented.
Le disque 1 présente un diamètre supérieur au diamètre de l'ouverture 2 à traiter.The disc 1 has a diameter greater than the diameter of the opening 2 to be treated.
Ce disque 1 peut être déformé pour pouvoir être engagé dans une gaine 10 permettant son acheminement jusqu'au site d'implantation, en empruntant un conduit vasculaire 11 , comme le montre la figure 9.This disc 1 can be deformed in order to be able to be engaged in a sheath 10 allowing its routing to the implantation site, by using a vascular duct 11, as shown in FIG. 9.
Le disque 1 est fixé à la paroi corporelle 3 au moyen d'attaches 15, plus particulièrement visibles sur les figures 3a à 3c.The disc 1 is fixed to the body wall 3 by means of fasteners 15, more particularly visible in FIGS. 3a to 3c.
Chaque attache 15 comprend deux surfaces d'appui distantes 16 déployables, séparées l'une de l'autre par une portion intermédiaire effilée 17 de longueur correspondant sensiblement à l'épaisseur additionnée de la paroi corporelle 3 et de la paroi 5 du disque 1.Each fastener 15 comprises two deployable remote bearing surfaces 16, separated from each other by a tapered intermediate portion 17 of length corresponding substantially to the added thickness of the body wall 3 and the wall 5 of the disc 1.
Chaque attache 15 est en "nitinol" et peut être déformée de manière à pouvoir être engagée dans une aiguille creuse 28 décrite plus loin. Dans le cas de l'attache 15 montrée par la figure 3a, les surfaces d'appuiEach fastener 15 is made of "nitinol" and can be deformed so as to be able to be engaged in a hollow needle 28 described below. In the case of the fastener 15 shown in FIG. 3a, the bearing surfaces
16 sont sous forme de spirales formées par un fil constituant l'attache ; dans le cas des attaches montrées par les figures 3b et 3c, les surfaces d'appui 16 sont sous forme de branches ou d'ailettes radiales disposées à 120° les unes des autres. Chaque attache 15 comprend en outre une douille taraudée 18 qui permet sa liaison amovible avec une tige de commande 20, visible sur les figures 13 et 14, cette dernière comportant une extrémité filetée correspondante. L'implantation du disque 1 est réalisée au moyen d'un ensemble comprenant, outre la gaine 10 précitée, la tige de manipulation 25 montrée sur la figure 4, la gaine de guidage 26 et le ou les cathéters 27 montrés sur les figures 5a à 6e, et une ou plusieurs aiguilles 28 dont une est montrée sur la figure 7.16 are in the form of spirals formed by a wire constituting the fastener; in the case of the fasteners shown in Figures 3b and 3c, the bearing surfaces 16 are in the form of branches or radial fins arranged at 120 ° from each other. Each fastener 15 further comprises a threaded socket 18 which allows its removable connection with a control rod 20, visible in Figures 13 and 14, the latter having a corresponding threaded end. The implantation of the disc 1 is carried out by means of an assembly comprising, in addition to the aforementioned sheath 10, the manipulation rod 25 shown in FIG. 4, the guide sheath 26 and the catheter (s) 27 shown in FIGS. 5a to 6th, and one or more needles 28, one of which is shown in FIG. 7.
Ces tige 25, gaine 26 et cathéters 27 présentent des longueurs telles qu'ils peuvent être manipulés depuis l'extérieur du corps du patient lorsque le disque 1 est niveau de la paroi 3, et ont des souplesses leur permettant de franchir les coudes que peut former le conduit vasculaire 11 utilisé pour leur introduction.These rod 25, sheath 26 and catheters 27 have lengths such that they can be manipulated from outside the patient's body when the disc 1 is level with the wall 3, and have flexibilities allowing them to cross the elbows that can form the vascular duct 11 used for their introduction.
La tige de manipulation 25 comprend une extrémité filetée 30 pouvant être vissée dans la douille 8 et assurer ainsi une liaison amovible du disque 1 à elle, et comporte une butée 31 solidaire d'elle, située en un emplacement déterminé, explicité plus loin. La gaine de guidage 26 a un diamètre tel qu'elle peut être engagée à coulissement sur la tige 25 jusqu'à venir contre la butée 31. Elle peut comporter de un à six cathéters 27, ces derniers étant régulièrement répartis sur son pourtour.The handling rod 25 comprises a threaded end 30 which can be screwed into the socket 8 and thus ensure a removable connection of the disc 1 to it, and comprises a stop 31 secured to it, located in a determined location, explained below. The guide sheath 26 has a diameter such that it can be slidably engaged on the rod 25 until it comes against the stop 31. It can comprise from one to six catheters 27, the latter being regularly distributed around its periphery.
Chaque cathéter 27 est relié à la gaine 26 et peut recevoir à coulissement une aiguille 28. Chaque cathéter 27 possède un embout proximal 32 permettant de le relier à une seringue d'injection d'un liquide approprié, afin que sa lumière puisse être purgée pour éviter les embolies.Each catheter 27 is connected to the sheath 26 and can slidingly receive a needle 28. Each catheter 27 has a proximal tip 32 allowing it to be connected to a syringe for injecting an appropriate liquid, so that its light can be purged for avoid embolism.
Chaque aiguille 28 est en alliage nickel-titane connu sous la dénomination "nitinol", et est deformable entre une forme sensiblement rectiligne, qu'elle prend lorsqu'elle est insérée dans le cathéter 27, et la forme défléchie montrée sur la figure 7, qu'elle prend lorsqu'elle est poussée hors du cathéter 27. Dans cette forme défléchie, elle présente une double courbure la divisant en une portion d'extrémité libre 28a, une portion intermédiaire oblique 28b et son autre portion d'extrémité 28c, ladite portion d'extrémité libre 28a étant déportée latéralement par rapport à cette autre portion d'extrémité 28c. Ce déport est tel qu'il permet à ladite portion d'extrémité libre 28a de venir en regard de la zone de la paroi corporelle 3 recouverte par la paroi 5 du disque 1 et de traverser cette zone lorsque l'aiguille 28 est poussée plus avant hors du cathéter 27, ainsi que le montrent les figures 12 et 13.Each needle 28 is made of a nickel-titanium alloy known under the name "nitinol", and is deformable between a substantially rectilinear shape, which it takes when it is inserted into the catheter 27, and the deflected shape shown in FIG. 7, that it takes when it is pushed out of the catheter 27. In this deflected form, it has a double curvature dividing it into a free end portion 28a, an oblique intermediate portion 28b and its other end portion 28c, said free end portion 28a being offset laterally relative to this other end portion 28c. This offset is such that it allows said free end portion 28a to come opposite the zone of the body wall 3 covered by the wall 5 of the disc 1 and to pass through this zone when the needle 28 is pushed further out of the catheter 27, as shown in FIGS. 12 and 13.
L'aiguille 28 est biseauté à son extrémité libre, comme le montre la figure 8, pour faciliter sa pénétration au travers des parois 3 et 5, et est raccordée par son autre extrémité à un cathéter 35 débouchant sur l'extérieur du patient, ce cathéter pouvant recevoir à coulissement une attache 15 reliée à une tige de commande 20.The needle 28 is bevelled at its free end, as shown in FIG. 8, to facilitate its penetration through the walls 3 and 5, and is connected by its other end to a catheter 35 opening onto the outside of the patient, this catheter capable of slidingly receiving a clip 15 connected to a control rod 20.
En pratique, comme le montrent les figures 9 à 15, le disque 1 relié à la tige 25 est acheminé vers la paroi 3, ce disque et cette tige étant contenus dans la gaine 10, laquelle maintient le disque à l'état contracté (figure 9), jusqu'au travers de l'ouverture 2 ; la gaine 10 est ensuite retirée pour permettre le déploiement du disque 1 (figure 10), puis la gaine de guidage 26 est engagée sur la tige 25 jusqu'à venue contre la butée 31 , et les aiguilles 28 et cathéter 35 sont engagés dans les cathéters 27 (figure 11) ; les aiguilles 28 sont alors poussées partiellement hors des cathéters 27 de manière à réaliser le déport précité de leurs extrémités libres 28a (aiguille de gauche sur la figure 12) puis leur insertion au travers des parois 3 et 5 (aiguille de droite sur la figure 12), et les attaches 15, reliées aux tiges 20, sont introduites et coulissées dans les cathéter 35 puis dans les aiguilles 28, jusqu'à déboucher hors de ces aiguilles 28, ce qui permet le déploiement des surfaces d'appui 16 distales (aiguille de gauche sur la figure 13) ; les aiguilles 28 sont alors reculées de manière à libérer les portions 17 et les autres surfaces d'appui 16 des attaches 15, réalisant la fixation du disque 1 à la paroi 3 (aiguille de droite sur la figure 13) ; les tiges 20 sont alors détachées des attaches 15 (figure 14) puis la tige 15 est détachée du disque 1 (figure 15).In practice, as shown in FIGS. 9 to 15, the disk 1 connected to the rod 25 is routed to the wall 3, this disk and this rod being contained in the sheath 10, which keeps the disk in the contracted state (FIG. 9), through the opening 2; the sheath 10 is then removed to allow the deployment of the disc 1 (FIG. 10), then the guide sheath 26 is engaged on the rod 25 until it comes against the stop 31, and the needles 28 and catheter 35 are engaged in the catheters 27 (Figure 11); the needles 28 are then partially pushed out of the catheters 27 so as to carry out the abovementioned offset from their free ends 28a (left needle in FIG. 12) then their insertion through the walls 3 and 5 (right needle in FIG. 12 ), and the fasteners 15, connected to the rods 20, are introduced and slid into the catheter 35 then into the needles 28, until opening out of these needles 28, which allows the deployment of the distal bearing surfaces 16 (needle on the left in Figure 13); the needles 28 are then moved back so as to free the portions 17 and the other bearing surfaces 16 from the fasteners 15, making the attachment of the disc 1 to the wall 3 (right needle in FIG. 13); the rods 20 are then detached from the fasteners 15 (FIG. 14) then the rod 15 is detached from the disc 1 (FIG. 15).
Les figures 16a et 16b montrent que la gaine 26 peut ne comprendre des cathéters 27 que sur un secteur marginal de sa périphérie ; des attaches 15 peuvent être mises en place à l'aide de l'ensemble comprenant une telle gaine et de tels cathéters que sur un secteur marginal correspondant du disque 1 , de manière à ce que ce disque 1 ne réalise pas une occlusion permanente de l'ouverture 2 à traiter et puisse fonctionner à la manière d'un clapet, comme le montrent les figures 17 et 18. Ce deuxième mode d'implantation peut être extrêmement intéressant chez les patients ayant une hypertension artérielle pulmonaire.Figures 16a and 16b show that the sheath 26 may include catheters 27 only on a marginal sector of its periphery; fasteners 15 can be put in place using the assembly comprising such a sheath and such catheters as on a corresponding marginal sector of the disc 1, so that this disc 1 does not achieve permanent occlusion of the opening 2 to be treated and can operate in the manner of a valve, as shown in FIGS. 17 and 18. This second embodiment can be extremely interesting in patients with pulmonary arterial hypertension.
L'invention fournit ainsi un dispositif d'occlusion d'une ouverture existant dans une paroi corporelle, implantable par voie très peu invasive, c'est-à-dire en passant par des conduits corporels, et présentant les avantages déterminants d'être peu encombrant, relativement facile à implanter et maintenu de façon sûre sur ladite paroi corporelle. L'invention fournit également un ensemble de mise en place de ce dispositif permettant une mise en place du dispositif de manière très peu invasive, en évitant le recours à des appareils annexes d'imagerie et surtout en permettant de maîtriser parfaitement le positionnement de la ou des aiguilles par rapport au disque et donc par rapport à la communication à fermer.The invention thus provides a device for occluding an opening existing in a body wall, which can be implanted by a minimally invasive route, that is to say by passing through bodily conduits, and having the determining advantages of being little bulky, relatively easy to implant and securely held on said body wall. The invention also provides a set of installation of this device allowing a positioning of the device in a very minimally invasive manner, by avoiding the use of additional imaging devices and above all by allowing to perfectly control the positioning of the or needles in relation to the disc and therefore in relation to the communication to be closed.
Il va de soi que l'invention n'est pas limitée à la forme de réalisation décrite ci-dessus à titre d'exemple mais qu'elle s'étend à toutes les formes de réalisations couvertes par les revendications ci-annexées.It goes without saying that the invention is not limited to the embodiment described above by way of example but that it extends to all the embodiments covered by the claims appended hereto.
En particulier, le ou les cathéters 27 peuvent être solidaires de la tige de manipulation 25, la position axiale de ce ou ces cathéters par rapport à cette tige étant alors déterminée par la liaison de ce ou ces cathéters à cette tige, en lieu et place de la butée 31. L'aiguille 28 peut être débouchante à son extrémité distale, comme montré sur les figures 7 et 8, ou peut comprendre une fente latérale au niveau de cette extrémité distale et être équipée d'un moyen amovible d'occultation de cette fente. Ce moyen amovible peut notamment être un tube souple coulissant dans l'aiguille. L'attache 15 est alors déployée au travers de cette fente latérale, cette dernière étant désoccultée par recul du tube coulissant.In particular, the catheter (s) 27 may be integral with the manipulation rod 25, the axial position of this or these catheters relative to this rod being then determined by the connection of this or these catheters to this rod, instead of the stop 31. The needle 28 can be through at its distal end, as shown in FIGS. 7 and 8, or can comprise a lateral slit at this distal end and be equipped with a removable means for concealing the this slot. This removable means can in particular be a flexible tube sliding in the needle. The fastener 15 is then deployed through this lateral slot, the latter being concealed by retraction of the sliding tube.
L'extrémité distale de l'aiguille peut, dans ce cas, être pleine, formant un cul-de-sac.The distal end of the needle may, in this case, be full, forming a dead end.
L'attache peut présenter, notamment pour une utilisation avec une aiguille comprenant une telle fente latérale, la forme d'une agrafe, c'est-à-dire comprendre deux branches d'extrémité, formant lesdites zones de liaison, et une branche intermédiaire, lesdites branches d'extrémité venant, à l'état déployé de l'attache, dans une position perpendiculaire à la branche intermédiaire. The fastener may have, in particular for use with a needle comprising such a lateral slit, the shape of a staple, that is to say comprise two end branches, forming said connecting zones, and an intermediate branch , said end branches coming, in the deployed state of the fastener, in a position perpendicular to the intermediate branch.

Claims

REVENDICATIONS
1 - Dispositif d'occlusion d'une ouverture (2) existant dans une paroi corporelle (3), implantable par voie mini-invasive, caractérisé en ce qu'il comprend :1 - Device for occluding an opening (2) existing in a body wall (3), implantable by a minimally invasive route, characterized in that it comprises:
- un disque unique (1), de diamètre supérieur au diamètre de l'ouverture (2) à traiter, formé par un fil périphérique deformable (6) en matériau à mémoire de forme et par une paroi souple (6) en un matériau biocompatible reliée à ce fil, ce disque (1) étant deformable entre un état normal de déploiement, dans lequel il peut être appliqué contre ladite paroi corporelle (3) et venir recouvrir l'ensemble de l'ouverture (2) à traiter, en s'étendant au-delà de celle-ci, et un état de contraction, dans lequel il peut être inséré dans une gaine (10) permettant de l'acheminer vers ladite paroi corporelle (3) en vue de sa mise en place, le disque (1) comportant des moyens (8) pour sa liaison amovible avec une tige de manipulation (25), permettant de mettre ce disque (1) en place et de le maintenir appliqué contre ladite paroi corporelle (3) ; et- a single disc (1), of diameter greater than the diameter of the opening (2) to be treated, formed by a deformable peripheral wire (6) made of shape memory material and by a flexible wall (6) made of a biocompatible material connected to this wire, this disc (1) being deformable between a normal state of deployment, in which it can be applied against said body wall (3) and come to cover the whole of the opening (2) to be treated, in s 'extending beyond it, and a state of contraction, in which it can be inserted in a sheath (10) allowing it to be conveyed towards said body wall (3) for its establishment, the disc (1) comprising means (8) for its removable connection with a manipulation rod (25), making it possible to put this disc (1) in place and to keep it applied against said body wall (3); and
- au moins une attache (15) séparée du disque (1), permettant la fixation de ce disque (1) à ladite paroi corporelle (3), chaque attache (15) comprenant une zone (16) de liaison au disque et une zone (16) de liaison à la paroi corporelle (3) et pouvant être déformée de manière à pouvoir être engagée dans une aiguille creuse (28).- At least one attachment (15) separate from the disc (1), allowing the attachment of this disc (1) to said body wall (3), each attachment (15) comprising a zone (16) for connection to the disc and a zone (16) connecting to the body wall (3) and which can be deformed so as to be able to be engaged in a hollow needle (28).
2 - Dispositif selon la revendication 1 , caractérisé en ce que les moyens pour la liaison amovible du disque (1) avec la tige de manipulation (25) comprennent un fil radial (7) solidaire dudit fil périphérique du disque (1), comportant, au niveau du centre du disque (1), une douille taraudée (8), ladite tige de manipulation (25) comprenant une extrémité filetée (30) pouvant être vissée dans cette douille (8).2 - Device according to claim 1, characterized in that the means for the removable connection of the disc (1) with the handling rod (25) comprise a radial wire (7) integral with said peripheral wire of the disc (1), comprising, at the center of the disc (1), a threaded socket (8), said manipulation rod (25) comprising a threaded end (30) which can be screwed into this socket (8).
3 - Dispositif selon la revendication 1 ou la revendication 2, caractérisé en ce que lesdites zones de liaison que comprend chaque attache (15) sont sous forme de deux surfaces d'appui (16) distantes déployables, séparées l'une de l'autre par une portion intermédiaire effilée (17) de longueur correspondant sensiblement à l'épaisseur additionnée de ladite paroi corporelle (3) et de ladite paroi souple (6) du disque (1) ; l'une desdites surfaces d'appui (16) de l'attache (15) est destinée à prendre appui contre ladite paroi souple (6) du disque (1) et l'autre surface d'appui (16) de cette attache (15) est destinée à prendre appui contre ladite paroi corporelle (3), du côté de cette paroi opposé au disque (1), ladite portion intermédiaire effilée (17) étant destinée à traverser ladite paroi corporelle (3)3 - Device according to claim 1 or claim 2, characterized in that said connecting zones that includes each fastener (15) are in the form of two support surfaces (16) deployable distant, separate from each other by a tapered intermediate portion (17) of length corresponding substantially to the added thickness of said wall body (3) and said flexible wall (6) of the disc (1); one of said support surfaces (16) of the fastener (15) is intended to bear against said flexible wall (6) of the disc (1) and the other support surface (16) of this fastener ( 15) is intended to bear against said body wall (3), on the side of this wall opposite to the disc (1), said tapered intermediate portion (17) being intended to pass through said body wall (3)
4 - Dispositif selon la revendication 3, caractérisé en ce que les surfaces d'appui (16) sont sous forme de spirales formées par un fil constituant l'attache (15), ou sous forme de branches ou d'ailettes radiales. 5 - Ensemble de mise en place du dispositif selon l'une des revendications 1 à 4, caractérisé en ce qu'il comprend :4 - Device according to claim 3, characterized in that the bearing surfaces (16) are in the form of spirals formed by a wire constituting the fastener (15), or in the form of branches or radial fins. 5 - assembly for installing the device according to one of claims 1 to 4, characterized in that it comprises:
- ladite gaine (10), propre à recevoir le disque (1) dans ledit état de contraction de ce disque (1) et à contenir ladite tige de manipulation (25) ;- Said sheath (10), adapted to receive the disc (1) in said state of contraction of this disc (1) and to contain said handling rod (25);
- au moins un cathéter (27) contenant ladite aiguille creuse (28), cette aiguille (28) étant en un matériau à mémoire de forme et étant deformable entre une forme sensiblement rectiligne, qu'elle prend lorsqu'elle est insérée dans le cathéter (27), et une forme dans laquelle sa portion d'extrémité libre (28a) est déportée latéralement par rapport à son autre portion d'extrémité (28c), forme qu'elle prend lorsqu'elle est poussée hors du cathéter (27), ce déport étant tel qu'il permet à ladite portion d'extrémité libre (28a) de venir en regard de la zone de ladite paroi corporelle (3) recouverte par ladite paroi souple (6) du disque (1) et de traverser cette zone lorsque l'aiguille (28) est poussée hors du cathéter (27) ; et- at least one catheter (27) containing said hollow needle (28), this needle (28) being of a shape memory material and being deformable between a substantially rectilinear shape, which it takes when it is inserted into the catheter (27), and a shape in which its free end portion (28a) is offset laterally relative to its other end portion (28c), the shape it takes when pushed out of the catheter (27) , this offset being such that it allows said free end portion (28a) to come opposite the area of said body wall (3) covered by said flexible wall (6) of the disc (1) and to pass through this area when the needle (28) is pushed out of the catheter (27); and
- une tige de commande (20), engagée dans le cathéter (27) et reliée de manière amovible à ladite attache (15), permettant de commander le coulissement de cette attache (15) à travers ladite aiguille (28).- A control rod (20), engaged in the catheter (27) and removably connected to said attachment (15), making it possible to control the sliding of this attachment (15) through said needle (28).
6 - Ensemble selon la revendication 5, caractérisé en ce que le cathéter6 - assembly according to claim 5, characterized in that the catheter
(27) est coulissant le long de la tige de manipulation (25), et en ce que la tige de manipulation (25) comprend une butée (31) permettant de positionner axialement le cathéter (27) par rapport au disque (1) de manière à réaliser le déport adéquat de ladite portion d'extrémité libre (28a) de l'aiguille (28). 7 - Ensemble selon la revendication 5 ou la revendication 6, caractérisé en ce que le cathéter (27) est monté pivotant autour de la tige de manipulation (25).(27) is sliding along the manipulation rod (25), and in that the manipulation rod (25) comprises a stop (31) making it possible to position the catheter (27) axially with respect to the disc (1) of so as to achieve the adequate offset of said free end portion (28a) of the needle (28). 7 - An assembly according to claim 5 or claim 6, characterized in that the catheter (27) is pivotally mounted around the manipulation rod (25).
8 - Ensemble selon la revendication 6, caractérisé en ce que le cathéter et la tige de manipulation comprennent respectivement un repère et une graduation permettant de positionner angulairement le cathéter par rapport à la tige de manipulation.8 - An assembly according to claim 6, characterized in that the catheter and the manipulation rod respectively comprise a mark and a graduation for angularly positioning the catheter relative to the manipulation rod.
9 - Ensemble selon la revendication 5 ou la revendication 6, caractérisé en ce qu'il comprend plusieurs cathéters (27) disposés angulairement selon les différentes implantations des attaches (15) à réaliser.9 - assembly according to claim 5 or claim 6, characterized in that it comprises several catheters (27) arranged angularly according to the different implantations of the fasteners (15) to be produced.
10 - Ensemble selon l'une des revendications 5 à 9, caractérisé en ce que les moyens de liaison amovible la tige de commande (20) et de l'attache (15) sont sous forme de douille taraudée (18) et d'extrémité filetée pouvant être vissée dans cette douille (18). 11 - Ensemble selon l'une des revendications 5 à 10, caractérisé en ce que l'aiguille comprend une fente latérale au niveau de son extrémité distale et est équipée d'un moyen amovible d'occultation de cette fente, notamment sous forme d'un tube souple coulissant dans l'aiguille10 - assembly according to one of claims 5 to 9, characterized in that the removable connection means the control rod (20) and the fastener (15) are in the form of threaded socket (18) and end threaded which can be screwed into this socket (18). 11 - assembly according to one of claims 5 to 10, characterized in that the needle comprises a lateral slot at its distal end and is equipped with a removable means for concealing this slot, in particular in the form of a flexible tube sliding in the needle
12 - Ensemble selon la revendication 11 , caractérisé en ce que l'extrémité distale de l'aiguille est pleine, formant un cul-de-sac.12 - assembly according to claim 11, characterized in that the distal end of the needle is full, forming a dead end.
13 - Méthode chirurgicale mini-invasive d'occlusion d'une ouverture (2) existant dans une paroi corporelle (3) comprenant les étapes consistant à :13 - Minimally invasive surgical method for occluding an opening (2) existing in a body wall (3) comprising the steps consisting in:
- utiliser un disque (1) unique, de diamètre supérieur au diamètre de l'ouverture (2) à traiter, formé par un fil périphérique deformable en matériau à mémoire de forme et par une paroi souple (6) en un matériau biocompatible reliée à ce fil, ce disque (1) étant deformable entre un état normal de déploiement, dans lequel il peut être appliqué contre ladite paroi corporelle (3) et venir recouvrir l'ensemble de l'ouverture (2) à traiter, et un état de contraction, dans lequel il peut être inséré dans une gaine (10) permettant de l'acheminer vers ladite paroi corporelle (3) en vue de sa mise en place, le disque (1) comportant en outre des moyens pour sa liaison amovible avec une tige de manipulation (25), permettant de mettre ce disque (1) en place et de le maintenir appliqué contre ladite paroi corporelle (3) ; et - utiliser au moins une attache (15) séparée du disque (1), permettant la fixation de ce disque (1) à ladite paroi corporelle (3), chaque attache (15) comprenant deux surfaces d'appui distantes déployables, séparées l'une de l'autre par une portion intermédiaire effilée de longueur correspondant sensiblement à l'épaisseur additionnée de ladite paroi corporelle (3) et de ladite paroi souple (6) du disque (1), l'attache (15) pouvant être déformée de manière à pouvoir être engagée dans une aiguille (28) creuse ; l'une desdites surfaces d'appui de l'attache (15) est destinée à prendre appui contre ladite paroi souple (6) du disque (1) et l'autre surface d'appui de cette attache (15) est destinée à prendre appui contre ladite paroi corporelle (3), du côté de cette paroi opposé au disque (1), ladite portion intermédiaire effilée étant destinée à traverser ladite paroi corporelle (3) ;- use a single disc (1), of diameter greater than the diameter of the opening (2) to be treated, formed by a deformable peripheral wire made of shape memory material and by a flexible wall (6) made of a biocompatible material connected to this wire, this disc (1) being deformable between a normal state of deployment, in which it can be applied against said body wall (3) and come to cover the whole of the opening (2) to be treated, and a state of contraction, in which it can be inserted into a sheath (10) allowing it to be conveyed towards said body wall (3) for its establishment, the disc (1) further comprising means for its removable connection with a manipulation rod (25), making it possible to place this disc (1) in place and to keep it applied against said body wall (3); and - Use at least one attachment (15) separate from the disc (1), allowing the attachment of this disc (1) to said body wall (3), each attachment (15) comprising two deployable remote support surfaces, separate the one from the other by a tapered intermediate portion of length corresponding substantially to the added thickness of said body wall (3) and said flexible wall (6) of the disc (1), the fastener (15) being able to be deformed by so as to be able to be engaged in a hollow needle (28); one of said support surfaces of the fastener (15) is intended to bear against said flexible wall (6) of the disc (1) and the other support surface of this fastener (15) is intended to take abutment against said body wall (3), on the side of this wall opposite the disc (1), said tapered intermediate portion being intended to pass through said body wall (3);
- utiliser un ensemble de mise en place du dispositif comprenant : (i) ladite gaine (10), propre à recevoir le disque (1) dans ledit état de contraction de ce disque (1) et à contenir ladite tige de manipulation (25) ; (ii) au moins un cathéter (27) contenant ladite aiguille (28) creuse, cette aiguille (28) étant en un matériau à mémoire de forme et étant deformable entre une forme sensiblement rectiligne, qu'elle prend lorsqu'elle est insérée dans le cathéter (27), et une forme dans laquelle sa portion d'extrémité libre est déportée latéralement par rapport à son autre portion d'extrémité, qu'elle prend lorsqu'elle est poussée hors du cathéter (27), ce déport étant tel qu'il permet à ladite portion d'extrémité libre de venir en regard de la zone de ladite paroi corporelle (3) recouverte par ladite paroi souple (6) du disque (1) et de traverser cette zone lorsque l'aiguille (28) est poussée hors du cathéter (27) ; et (iii) une tige de commande, engagée dans le cathéter (27) et reliée de manière amovible à ladite attache (15), permettant de commander le coulissement de cette attache (15) à travers ladite aiguille (28) ;- Use a device placement assembly comprising: (i) said sheath (10), suitable for receiving the disc (1) in said state of contraction of this disc (1) and for containing said manipulation rod (25) ; (ii) at least one catheter (27) containing said hollow needle (28), this needle (28) being of a shape memory material and being deformable between a substantially rectilinear shape, which it takes when it is inserted into the catheter (27), and a shape in which its free end portion is offset laterally relative to its other end portion, which it takes when it is pushed out of the catheter (27), this offset being such that it allows said free end portion to come opposite the area of said body wall (3) covered by said flexible wall (6) of the disc (1) and to pass through this area when the needle (28) is pushed out of the catheter (27); and (iii) a control rod, engaged in the catheter (27) and removably connected to said clip (15), making it possible to control the sliding of this clip (15) through said needle (28);
- acheminer le disque (1), relié à la tige de manipulation (25), vers la paroi corporelle (3) à traiter au moyen de ladite gaine (10) puis déployer ce disque (1) par retrait de cette gaine (10) et plaquer le disque (1) contre la paroi corporelle (3) au moyen de la tige de manipulation (25) ;- route the disc (1), connected to the handling rod (25), to the body wall (3) to be treated by means of said sheath (10) then deploy this disc (1) by removing this sheath (10) and pressing the disc (1) against the body wall (3) by means of the manipulation rod (25);
- pousser l'aiguille (28) creuse hors du cathéter (27) qui la contient de manière à réaliser le déport de sa portion d'extrémité libre puis son enfoncement à travers ladite zone de la paroi corporelle (3) recouverte par la paroi souple (6) du disque (1) ;- Push the hollow needle (28) out of the catheter (27) which contains it so as to offset its free end portion then its sinking through said zone of the body wall (3) covered by the flexible wall (6) of the disc (1);
- pousser l'attache (15) au travers de l'aiguille (28) au moyen de ladite tige de commande pour extraire l'une des surfaces d'appui de l'attache (15) hors de l'aiguille (28) et déployer cette surface, puis reculer l'aiguille (28) pour extraire ladite portion intermédiaire effilée et l'autre surface d'appui de l'attache (15) de telle sorte que cette autre surface d'appui vienne prendre appui contre la paroi corporelle (3) du côté opposé à celui contre lequel ce trouve le disque (1). 14 - Méthode chirurgicale selon la revendication 13, caractérisée en ce que des attaches (15) sont mises en place sur l'ensemble de la périphérie du disque (1), de manière à maintenir ce disque (1) contre la paroi corporelle (3) et à réaliser une occlusion permanente de l'ouverture (2) que comprend cette paroi. 15 - Méthode chirurgicale selon la revendication 13, caractérisée en ce qu'une ou plusieurs attaches (15) sont mises en place sur un secteur marginal de la périphérie du disque (1), de manière à ce que le disque (1) ne réalise pas une occlusion permanente de l'ouverture (2) à traiter et puisse fonctionner à la manière d'un clapet. - push the fastener (15) through the needle (28) by means of said control rod to extract one of the support surfaces of the fastener (15) from the needle (28) and deploy this surface, then move the needle back (28) to extract said tapered intermediate portion and the other bearing surface of the fastener (15) so that this other bearing surface comes to bear against the body wall (3) on the opposite side to that against which this disc is (1). 14 - Surgical method according to claim 13, characterized in that fasteners (15) are placed over the entire periphery of the disc (1), so as to maintain this disc (1) against the body wall (3 ) and to achieve a permanent occlusion of the opening (2) that this wall includes. 15 - Surgical method according to claim 13, characterized in that one or more fasteners (15) are placed on a marginal sector of the periphery of the disc (1), so that the disc (1) does not realize not a permanent occlusion of the opening (2) to be treated and can function like a valve.
EP03750855A 2002-08-01 2003-07-28 Device for occluding a hole in a body wall and a unit for inserting said device Withdrawn EP1531735A2 (en)

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WOPCT/FR02/09807 2002-08-01
FR0209807A FR2843012B1 (en) 2002-08-01 2002-08-01 DEVICE FOR CLOSING SEGMENTED DEFECTS BY NON-SURGICAL METHOD
PCT/FR2003/002386 WO2004012572A2 (en) 2002-08-01 2003-07-28 Device for occluding a hole in a body wall and a unit for inserting said device

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CA2494733A1 (en) 2004-02-12
WO2004012572A3 (en) 2004-05-13
JP2005534394A (en) 2005-11-17
FR2843012A1 (en) 2004-02-06
AU2003269071A1 (en) 2004-02-23
WO2004012572A2 (en) 2004-02-12
US20050245964A1 (en) 2005-11-03
AU2003269071A8 (en) 2004-02-23
FR2843012B1 (en) 2005-05-13
US7273489B2 (en) 2007-09-25

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