WO1995008310A1 - Implantable device for the treatment of ×demas - Google Patents

Implantable device for the treatment of ×demas Download PDF

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Publication number
WO1995008310A1
WO1995008310A1 PCT/IB1994/000284 IB9400284W WO9508310A1 WO 1995008310 A1 WO1995008310 A1 WO 1995008310A1 IB 9400284 W IB9400284 W IB 9400284W WO 9508310 A1 WO9508310 A1 WO 9508310A1
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WIPO (PCT)
Prior art keywords
tube
intended
drainage tube
implanted
drainage
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PCT/IB1994/000284
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French (fr)
Inventor
François PITHON
Original Assignee
Voir Et Vivre E U R L
Pithon Francois
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Filing date
Publication date
Application filed by Voir Et Vivre E U R L, Pithon Francois filed Critical Voir Et Vivre E U R L
Priority to AU75455/94A priority Critical patent/AU7545594A/en
Publication of WO1995008310A1 publication Critical patent/WO1995008310A1/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F9/00—Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/007—Methods or devices for eye surgery
    • A61F9/00781—Apparatus for modifying intraocular pressure, e.g. for glaucoma treatment

Definitions

  • the present invention relates to devices or other systems, implantable in humans or animals for treating edematous collections.
  • the description below relates more particularly to devices implantable in the eye, both inside and outside the eyeball, making it possible to treat glaucoma, without, however, the scope of the invention be limited.
  • the device of the invention applies to the treatment of any edematous collection of the human and animal body such as cerebral, renal edema and hydrocephalus ...
  • Glaucoma is an eye disease, which can take acute or particularly severe forms, to the point of causing partial or total blindness in the patient. This disease is generally characterized *, by hypertonia of the eyeball, namely an increase in intraocular pressure, which increases the hardness of the globe and causes compression of the optic nerve, with a decrease in visual acuity.
  • glaucoma is most often treated by trabeculectomy.
  • This operating technique consists in incising the corneo-sawn trabeculum, to create a valve evacuating the aqueous humor in overpressure towards the space under conjunctival.
  • the upstream end of the drainage tube penetrates and is held in the anterior chamber, while the other downstream end is first implanted under the shutter sawn, then under the conjunctiva, where the aqueous humor is evacuated, to be diffused and absorbed by the surrounding tissues.
  • the drainage tube has at least in part sufficient flexibility to adapt to the shape or local contour of the sclera.
  • the device described in O-A-91 07195 requires the use of a special pocket placed in the sclera.
  • the device described in O-A-92 00112 is not intrascleral; it is placed under the superficial layers of the cornea, which obviously cannot guarantee proper retention, even relatively short term.
  • the device described in US-A-4 521 210 its complexity will be judged, in particular because it is necessary to use lateral support legs (cross shape), legs which moreover are likely to be a discomfort for the eye or being poorly tolerated by the body.
  • the present invention therefore relates to an implantable device comprising a drainage tube, overcoming the drawbacks of conventional trabeculectomies, and the other drawbacks mentioned above, by associating therewith the implantation of non-obturable drains.
  • the subject of the invention is a device making it possible to diffuse the bodily fluid to be evacuated such as the aqueous humor, while ensuring that it cannot be blocked for the entire duration of its implantation by cell colonies.
  • the drainage tube or tubes each have, over the major part of their length between the upstream end and the downstream end, and in particular in their part in contact with the discharge zone, a permeability lateral, making it possible to diffuse almost all of the liquid to be evacuated withdrawn by the upstream end, from the inside to the outside and through the wall of said tube, but opposing cell migration from the outside to the inside said tube.
  • the tube is in a position that is not completely intrascleral and extends and emerges inside the anterior chamber.
  • the not entirely sawn path of the tube (s) means that their respective end exceeds the equator of the eyeball to lead into an area where the structures adjoining it are much less dense, which effectively prevents the obstruction or clogging of the drainage by scar processes.
  • the tube or tubes emerge from the sawn shutter with a length of between 1.5 and 3 mm.
  • a drainage tube then behaves as a lateral diffuser of the aqueous humor, and this in a particularly simple manner.
  • the drainage tube comprises, at least in its part in contact with the evacuation zone, a multiplicity of porosities with micro-perforations passing through its wall right through, and distributed throughout its lateral surface;
  • the material of the drainage tube is continuous, that is to say non-perforated, but semi-permeable, at least from the inside towards the outside, thus allowing a continuous diffusion in the same sense, of aqueous humor, by simple permeation;
  • each drainage tube is a hollow, porous fiber, in particular having a diameter between 0.3 and 1.2 mm, and a wall thickness of more than 50 micrometers;
  • the device according to the invention may comprise one or more drainage tubes, independent of each other; in the latter case, the drainage tubes can be connected or held together by a flat fastening means, for example by a wire link or of the matrix type encompassing them or else a biocompatible glue (in particular polyurethane), and the downstream ends of the tubes are
  • the downstream end of the drainage tube is open;
  • the material of the drainage tube is preferably hydrophilic, but can be chosen from the following flexible products, namely silicone, polymethyl methacrylate (abbreviated PMMA), and polyvinyldifluoroethylene (PVDF), hydrogel whatever it may be;
  • the drainage tube is a hydrophilic hollow fiber and in particular a hollow fiber derived from cellulosic products, a hollow fiber made of type material ethylene / vinyl alcohol, polymethyl-methacrylate, simple polyacrylonitrile or coupled to sodium methallyl-sulfonate, polysulfone and any other combination of materials making it possible to produce a porous tubule such as those already used for artificial kidneys;
  • the material of the drainage tube can also be chosen from rigid products such as a porous ceramic and in particular simple alumina, zirconia-alumina and tetragonal zirconia; all of these flexible or rigid materials which could have benefited from any type of surface treatment;
  • the porosity is preferably between 10 and 95%.
  • any biocompatible polymeric substance as used to produce any intraocular lens capable of being implanted on the optical axis in the corneal thickness, in the anterior chamber of the eye, between the iris and the natural lens (resting against the latter), or in the lens sac in place of the natural lens, or in the vitreous compartment further back, and capable of correcting any form of optical anomaly (aphakia, high myopia, hyperopia, astigmatism, even presbyopia, and magnifying system for ocular degeneration).
  • the materials selected must have the following characteristics or properties: preferably be micro-porous, both to simplify the production of the tube or tubes, and to avoid any invasion by cell proliferation, even late;
  • Hydrogels and more generally any material used in artificial kidneys constitute preferred materials for obtaining the tube or tubes belonging to a device according to the invention.
  • hydrogels or "gels containing water” are synthetic polymers absorbing water, of soft but firm consistency induced by their hydrophilicity and their insolubility in water. These hydrogels are obtained by copolymerization of monomers having water-solubilizing groups, for example hydroxyl, with other monomers, for example ethylene dimethacrylate. These hydrogels are widely used in ophthalmology, for example for corneal dressings.
  • the hydrogels have proved to be well suited, since their hydrophilicity makes it possible to absorb water, while opposing a migration of cells and large molecules (PM greater than 40000 Dalton). Furthermore, they have good oxygen permeability, are optically transparent, and have been found to be mechanically durable.
  • hydrogel acrylonitrile / sodium methallyl sulfonate is preferred as having, in particular, a high permeability towards liquids, capable of ensuring a significant filtration in glaucoma.
  • Her Biocompatibility is excellent, since in particular it is the most hemo-compatible of the high flux fibers known for artificial kidney.
  • tubes and tubes with an outside diameter of 340 microns, an inside diameter of 240 microns were obtained and used, and by Consequently, a wall 50 microns thick.
  • These tubes are glycerins before their use, have a high permeability, for example of the order of 60 ml / h / m 2 / mm of Hg, thanks to an outside pore diameter of less than 100 Angstroms.
  • hydrogel fibers already satisfactory when they are obtained, can be further improved by an appropriate surface treatment, for example with treatment at room temperature, in one or more stages, with a long aliphatic chain with sequences at different temperatures.
  • Figure 1 shows an anatomical sectional view of an eye and the sawdust flap, with respect to which a device according to the invention is implanted;
  • Figures 2, 3, 4 show, in correspondence with Figure 1, the eyeball with the sawdust flap, under which a device according to the invention is implanted;
  • FIG. 5 shows in an enlarged manner, and with partial cutaway, a drainage tube forming part of the device shown in Figures 1 and 2, the pores being generally invisible to the naked eye.
  • the device 1 makes it possible to evacuate the aqueous humor from the anterior ocular chamber 4 towards the scleral shell 5.
  • This device here comprises a plurality of drainage tubes 6, whose upstream or anterior end 6a is implanted in the anterior chamber 4 and whose other downstream or posterior end 6b is implanted under the conjunctiva 11 beyond the sawdust flap 8, the reference 9 representing the sclera and / or choroid.
  • each tube is made of a material biocompatible with the eye, in particular of a hydrophilic material capable of being wetted by the aqueous humor, for example hydrogel, and at the same time has sufficient flexibility to adapt to the shape of the scleral shell 5 and the eyeball.
  • each tube 6 comprises, at least in its sclerotic part 6c, that is to say in its part disposed after implantation under the sawdust flap 8, and in the anterior chamber 4, a porosity or a multiplicity of micro-perforations 6d passing through its wall right through, and distributed throughout its lateral surface.
  • the porous tubes v have openings less than one micron, to avoid any cellular invasion.
  • a single tube may suffice, but as a general rule and to properly regulate drainage, 3 to 7 tubes will be used on average per eye.
  • the drainage tube or tubes are implanted in the eye, after cutting a sawdust flap 8, which is then replaced by sewing according to FIG. 3, the corresponding surgical act being described below. after.
  • each of the tubes 6 can be replaced by a semi-permeable hollow fiber, such as those used in renal dialysis devices, that is to say made of a semi-permeable material, for example a micro-porous polymer, such as hollow fibers or hydrogels.
  • a semi-permeable hollow fiber such as those used in renal dialysis devices, that is to say made of a semi-permeable material, for example a micro-porous polymer, such as hollow fibers or hydrogels.
  • a drainage tube according to the invention is preferably delivered sterile ready for use and is implanted in a few minutes, under a microscope, during the intervention.
  • the drainage tube is then cut obliquely at its two ends to allow, in the anterior chamber, a sampling zone at its wider upstream end of the aqueous humor, and to more easily avoid any endothelial contact, by suitable rotation to the tube.
  • the cut is identical, both so that the tube can, if necessary, be turned over at the time of implantation, as to allow posterior contact as smooth and harmonious as possible.
  • the sterilization of the perforated drainage tube can be carried out:
  • the drainage tube is put in place during a simple trabeculectomy or trepanotrabulectomy performed with 1.7 mm Elliot drill bit, so that the drainage tube (0.7 mm) can be easily inserted diameter or less if three polymer fibers acrylonitrile or derivative are used), in a slightly larger rounded orifice.
  • the drainage tube is then slid under the conjunctiva in a radial fashion, towards the equator of the globe which it must exceed behind.
  • the drainage tube can be fixed under the sawdust shutter, either by a separate point with a 10/0 prolene wire (0.2) by plating the bridge into the sclera and making a "dead turn" around the tube , or simply by closing the scleral flap, even if it has produced a passage strap for the tubule further on the ocular shell. Before tightening any possible point, it is important to ensure, to better protect the corneal endothelium, that:
  • the length which emerges in the anterior chamber is approximately 2 mm
  • the oblique section of the upstream or anterior end of the tube is turned upwards, that is to say that the space between the endothelium and the drainage tube increases towards the pupil, due to the oblique section of the upstream end.
  • the length of the tubes around the point 10 of their bundling is between 4 and 5 mm and their posterior part 6c extends for example over a length of between 8 and 24 mm.
  • This same type of drainage device can be introduced in a comparable way into the space where the cerebrospinal fluid possibly overpressure to the surrounding connective tissue.

Abstract

Device (1) implantable in any human or animal living organism, intended to evacuate any liquid from an ÷dematic collection, comprising at least one draining tube (6) of which one upstream extremity (6a) is intended to be implanted in the serous cavity in overpressure conditions, and of which another downstream extremity (6b) is intended to be implanted in the evacuation zone, said tube presenting at least partly a sufficient flexibility so that it can be adapted to the shape of the part wherein it is implanted, and being made of at least one biocompatible material, characterized in that the tube presents on the major part of its length between its upstream extremity (6a) and its downstream extremity (6b), and particularly in the portion intended to be associated with the evacuation zone, a lateral permeability providing for a diffusion of substantially all the liquid taken through its upstream extremity (6a), from the inside to the outside and through the wall of said tube, but in a direction opposite to a cellular migration from the outside to the inside of said tube.

Description

DISPOSITIF IMPLANTABLE POUR LE TRAITEMENT DES OEDEMES IMPLANTABLE DEVICE FOR THE TREATMENT OF OEDEMAS
La présente invention concerne les dispositifs ou autres systèmes, implantables chez l'humain ou l'animal pour traiter des collections oedémateuses.The present invention relates to devices or other systems, implantable in humans or animals for treating edematous collections.
La description ci-après se rapporte plus particulièrement aux dispositifs implantables dans l'oeil, à la fois à l'intérieur et à l'extérieur du globe oculaire, permettant de traiter le glaucome, sans pour autant que la portée de l'invention y soit limitée. En effet, le dispositif de l'invention s'applique au traitement de toute collection oedémateuse du corps humain et animal comme les oedèmes cérébraux, rénaux et les hydrocéphalies...The description below relates more particularly to devices implantable in the eye, both inside and outside the eyeball, making it possible to treat glaucoma, without, however, the scope of the invention be limited. Indeed, the device of the invention applies to the treatment of any edematous collection of the human and animal body such as cerebral, renal edema and hydrocephalus ...
Le glaucome est une maladie de l'oeil, pouvant prendre des formes aiguës ou particulièrement graves, au point d'entraîner une cécité partielle ou totale du malade. Cette maladie se caractérise de manière générale*, par une hypertonie du globe oculaire, à savoir une élévation de la pression intra-oculaire, qui augmente la dureté du globe et provoque une compression du nerf optique, avec une diminution de l'acuité visuelle.Glaucoma is an eye disease, which can take acute or particularly severe forms, to the point of causing partial or total blindness in the patient. This disease is generally characterized *, by hypertonia of the eyeball, namely an increase in intraocular pressure, which increases the hardness of the globe and causes compression of the optic nerve, with a decrease in visual acuity.
En ophtalmologie, les glaucomes sont le plus souvent traités par trabéculectomie. Cette technique opératoire consiste à inciser le trabéculum cornéo-scierai, pour créer une soupape évacuant l'humeur aqueuse en surpression vers l'espace sous conjonctival. Mais pour palier à des phénomènes de cicatrisation, on peut y associer l'introduction d'un tube de drainage biocompatible avec l'oeil, permettant d'évacuer l'excès d'humeur aqueuse de la chambre oculaire antérieure.In ophthalmology, glaucoma is most often treated by trabeculectomy. This operating technique consists in incising the corneo-sawn trabeculum, to create a valve evacuating the aqueous humor in overpressure towards the space under conjunctival. But to overcome healing phenomena, we can associate the introduction of a biocompatible drainage tube with the eye, allowing to remove excess aqueous humor from the anterior ocular chamber.
A cette fin, l'extrémité amont du tube de drainage pénètre et est maintenue dans la chambre antérieure, tandis que l'autre extrémité avale est implantée d'abord sous le volet scierai, puis sous la conjonctive, où l'humeur aqueuse est évacuée, pour être diffusée et absorbée par les tissus environnants. Le tube de drainage présente au moins en partie une souplesse suffisante pour s'adapter à la forme ou au contour local de la sclère.To this end, the upstream end of the drainage tube penetrates and is held in the anterior chamber, while the other downstream end is first implanted under the shutter sawn, then under the conjunctiva, where the aqueous humor is evacuated, to be diffused and absorbed by the surrounding tissues. The drainage tube has at least in part sufficient flexibility to adapt to the shape or local contour of the sclera.
Une telle technique a montré ses limites, en ce sens que le tube de drainage peut se trouver colonisé par une prolifération cellulaire ou fibrose, au point de s'obturer progressivement, en particulier à son extrémité avale. Dans ces conditions, le glaucome réapparaît progressivement et nécessite une nouvelle intervention.Such a technique has shown its limits, in the sense that the drainage tube can be colonized by cell proliferation or fibrosis, to the point of gradually closing off, in particular at its downstream end. Under these conditions, glaucoma reappears gradually and requires a new intervention.
Incidemment, des exemples de cette technique peuvent être trouvés dans les exposés d'invention WO-A-91 07195, WO-A-92 00112 et US-A-4 521 210, où le ou les tubes de drainage sont totalement en position interne et de ce fait débouchent dans la chambre antérieure en y affleurant. A l'expérience, une telle position n'est pas satisfaisante, car elle empêche mal la recolonisation cellulaire.Incidentally, examples of this technique can be found in the disclosure of the invention WO-A-91 07195, WO-A-92 00112 and US-A-4 521 210, where the drainage tube or tubes are completely in the internal position and therefore open into the anterior chamber by flush with it. In experience, such a position is not satisfactory, because it does not prevent cell recolonization.
En outre, le dispositif décrit dans O-A-91 07195 nécessite l'utilisation d'une poche spéciale placée dans la sclère. Le dispositif décrit dans O-A-92 00112 n'est pas intrascléral ; il est placé sous les couches superficielles de la cornée, ce qui ne peut évidemment pas garantir un maintien en place correct, même relativement à court terme. Quant au dispositif décrit dans US-A-4 521 210, on jugera de sa complexité, du fait en particulier qu'il faut utiliser des pattes latérales de support (forme en croix) , pattes qui de surcroît ont toute chance d'être une gêne pour l'oeil ou d'être mal tolérées par l'organisme.In addition, the device described in O-A-91 07195 requires the use of a special pocket placed in the sclera. The device described in O-A-92 00112 is not intrascleral; it is placed under the superficial layers of the cornea, which obviously cannot guarantee proper retention, even relatively short term. As for the device described in US-A-4 521 210, its complexity will be judged, in particular because it is necessary to use lateral support legs (cross shape), legs which moreover are likely to be a discomfort for the eye or being poorly tolerated by the body.
La présente invention a donc pour objet un dispositif implantable comprenant un tube de drainage, remédiant aux inconvénients des trabéculectomies classiques, et aux autres inconvénients mentionnés ci-dessus, en y associant l'implantation de drains non obturables. Plus précisément, l'invention a pour objet un dispositif permettant de diffuser le liquide corporel à évacuer tel que l'humeur aqueuse, en veillant à ce qu'il ne puisse être obturé pendant toute la durée de son implantation par des colonies cellulaires.The present invention therefore relates to an implantable device comprising a drainage tube, overcoming the drawbacks of conventional trabeculectomies, and the other drawbacks mentioned above, by associating therewith the implantation of non-obturable drains. More specifically, the subject of the invention is a device making it possible to diffuse the bodily fluid to be evacuated such as the aqueous humor, while ensuring that it cannot be blocked for the entire duration of its implantation by cell colonies.
Conformément à l'invention, le ou les tubes de drainage utilisés présentent chacun, sur la majeure partie de leur longueur entre l'extrémité amont et l'extrémité avale, et notamment dans leur partie au contact de la zone d'évacuation, une perméabilité latérale, permettant de diffuser la quasi-totalité du liquide à évacuer prélevé par l'extrémité amont, de l'intérieur vers l'extérieur et par la paroi dudit tube, mais s'opposant à une migration cellulaire de l'extérieur vers l'intérieur dudit tube. Le tube est en position non totalement intrasclérale et se prolonge et émerge à l'intérieur de la chambre antérieure.According to the invention, the drainage tube or tubes each have, over the major part of their length between the upstream end and the downstream end, and in particular in their part in contact with the discharge zone, a permeability lateral, making it possible to diffuse almost all of the liquid to be evacuated withdrawn by the upstream end, from the inside to the outside and through the wall of said tube, but opposing cell migration from the outside to the inside said tube. The tube is in a position that is not completely intrascleral and extends and emerges inside the anterior chamber.
Le trajet non entièrement scierai du ou des tubes fait que leur extrémité respective dépasse l'équateur du globe oculaire pour déboucher dans une zone où les structures le jouxtant sont beaucoup moins denses, ce qui évite efficacement l'obturation ou le colmatage du drainage par des processus cicatriciels. Typiquement pour un oeil humain, le ou les tubes émergent du volet scierai d'une longueur comprise entre 1,5 et 3 mm.The not entirely sawn path of the tube (s) means that their respective end exceeds the equator of the eyeball to lead into an area where the structures adjoining it are much less dense, which effectively prevents the obstruction or clogging of the drainage by scar processes. Typically for a human eye, the tube or tubes emerge from the sawn shutter with a length of between 1.5 and 3 mm.
Selon l'invention, un tube de drainage se comporte alors en diffuseur latéral de l'humeur aqueuse, et ceci de manière particulièrement simple.According to the invention, a drainage tube then behaves as a lateral diffuser of the aqueous humor, and this in a particularly simple manner.
La présente invention présente encore les modalités d'exécution suivantes : - selon une première modalité d'exécution, le tube de drainage comprend, au moins dans sa partie en contact avec la zone d'évacuation, une multiplicité de porosités avec micro-perforations traversant sa paroi de part en part, et distribuées dans toute sa surface latérale ; selon une autre modalité d'exécution, le matériau du tube de drainage est continu, c'est-à-dire non perforé, mais semi-perméable, au moins de l'intérieur vers l'extérieur, en permettant ainsi une diffusion continue dans le même sens, de l'humeur aqueuse, par simple perméation ; preferentiellement, chaque tube de drainage est une fibre creuse, poreuse, notamment ayant un diamètre compris entre 0,3 et 1,2 mm, et une épaisseur de paroi de plus de 50 micromètres ; - le dispositif selon l'invention peut comprendre un ou plusieurs tubes de drainage, indépendants les uns des autres ; dans ce dernier cas, les tubes de drainage peuvent être reliés ou maintenus les uns aux autres par un moyen de solidarisation à plat, par exemple par un lien à fil ou du type matrice les englobant ou encore une colle biocompatible (notamment polyuréthanne) , et les extrémités avales des tubes sont étalées dans la zone d'évacuation ; il est important de signaler ici que l'ensemble tient par un simple renflement correspondant au point matriciel ou de collage et ne comprend aucune patte de fixation comme dans l'exposé US précité ; cet épaississement limité sur la trajectoire des tubes permet de fixer le dispositif par simple rabattement du volet scierai, tant par rapport à son introduction dans la chambre antérieure que par rapport à son émergence à l'extérieur du volet scierai autour de la coque oculaire ; les mêmes remarques en ce qui concerne la fixation étant applicables d'ailleurs au cas où il n'y a qu'un seul tube ;The present invention also presents the following execution methods: - according to a first embodiment, the drainage tube comprises, at least in its part in contact with the evacuation zone, a multiplicity of porosities with micro-perforations passing through its wall right through, and distributed throughout its lateral surface; according to another embodiment, the material of the drainage tube is continuous, that is to say non-perforated, but semi-permeable, at least from the inside towards the outside, thus allowing a continuous diffusion in the same sense, of aqueous humor, by simple permeation; preferably, each drainage tube is a hollow, porous fiber, in particular having a diameter between 0.3 and 1.2 mm, and a wall thickness of more than 50 micrometers; - The device according to the invention may comprise one or more drainage tubes, independent of each other; in the latter case, the drainage tubes can be connected or held together by a flat fastening means, for example by a wire link or of the matrix type encompassing them or else a biocompatible glue (in particular polyurethane), and the downstream ends of the tubes are spread out in the evacuation zone; it is important to point out here that the assembly holds by a simple bulge corresponding to the matrix or bonding point and does not include any fixing lug as in the aforementioned US disclosure; this limited thickening on the trajectory of the tubes makes it possible to fix the device by simple folding down of the sawdust flap, both in relation to its introduction into the anterior chamber and in relation to its emergence outside the sawdust flap around the ocular shell; the same remarks with regard to the fixing being applicable moreover in the case where there is only one tube;
- preferentiellement, l'extrémité avale du tube de drainage est ouverte ; le matériau du tube de drainage est preferentiellement hydrophile, mais peut être choisi parmi les produits souples suivants, à savoir silicone, polyméthacrylate de méthyle (en abrégé PMMA) , et polyvinyldifluoroéthylène (PVDF) , hydrogel quel qu'il soit ; preferentiellement le tube de drainage est une fibre creuse hydrophile et notamment une fibre creuse dérivée de produits cellulosiques, une fibre creuse en matériau de type éthylène/vinyle alcool, polyméthyl-méthacrylate, polyacrylo- nitrile simple ou couplé au sodium méthallyl-sulfonate, polysulfone et toute autre combinaison de matériaux permettant de réaliser un tubule poreux tel que ceux déjà employés pour les reins artificiels ; le matériau du tube de drainage peut être aussi choisi parmi les produits rigides comme une céramique poreuse et en particulier de l'alumine simple, de la zircone-alumine et de la zircone tétragonale ; l'ensemble de ces matériaux souples ou rigides ayant pu bénéficier de tout type de traitement de surface ;- Preferably, the downstream end of the drainage tube is open; the material of the drainage tube is preferably hydrophilic, but can be chosen from the following flexible products, namely silicone, polymethyl methacrylate (abbreviated PMMA), and polyvinyldifluoroethylene (PVDF), hydrogel whatever it may be; preferentially the drainage tube is a hydrophilic hollow fiber and in particular a hollow fiber derived from cellulosic products, a hollow fiber made of type material ethylene / vinyl alcohol, polymethyl-methacrylate, simple polyacrylonitrile or coupled to sodium methallyl-sulfonate, polysulfone and any other combination of materials making it possible to produce a porous tubule such as those already used for artificial kidneys; the material of the drainage tube can also be chosen from rigid products such as a porous ceramic and in particular simple alumina, zirconia-alumina and tetragonal zirconia; all of these flexible or rigid materials which could have benefited from any type of surface treatment;
- pour le ou les tubes de drainage réalisés, consistant chacun en une fibre creuse hydrophile poreuse, la porosité est preferentiellement comprise entre 10 et 95 %.- For the drainage tube (s) produced, each consisting of a porous hydrophilic hollow fiber, the porosity is preferably between 10 and 95%.
Peut être utilisée pour l'obtention d'un tube de drainage selon la présente invention, toute substance polymerique biocompatible, telle qu'employée pour réaliser toute lentille intra-oculaire susceptible d'être implantée sur l'axe optique dans l'épaisseur cornéenne, dans la chambre antérieure de l'oeil, entre l'iris et le cristallin naturel (posé contre ce dernier) , ou dans le sac cristallinien à la place du cristallin naturel, ou encore dans la loge vitréenne plus en arrière, et susceptible de corriger toute forme d'anomalie optique (aphakie, myopie forte, hypermétropie, astigmatisme, voire presbytie, et système grossissant pour dégénérescence oculaire) .Can be used to obtain a drainage tube according to the present invention, any biocompatible polymeric substance, as used to produce any intraocular lens capable of being implanted on the optical axis in the corneal thickness, in the anterior chamber of the eye, between the iris and the natural lens (resting against the latter), or in the lens sac in place of the natural lens, or in the vitreous compartment further back, and capable of correcting any form of optical anomaly (aphakia, high myopia, hyperopia, astigmatism, even presbyopia, and magnifying system for ocular degeneration).
Da manière générale, les matériaux retenus doivent présenter les caractéristiques ou propriétés suivantes : être de préférence micro-poreux, tant pour simplifier la réalisation du ou des tubes, que pour éviter tout envahissement par une prolifération cellulaire, même tardive ;In general, the materials selected must have the following characteristics or properties: preferably be micro-porous, both to simplify the production of the tube or tubes, and to avoid any invasion by cell proliferation, even late;
- n'être ni biodégradables, ni résorbables, pour permettre une diffusion permanente et durable du liquide à évacuer ; - n'être ni réactogènes, ni irritants pour ne favoriser aucune réaction de fibrose locale, entravant l'efficacité du dispositif à moyen terme ;- be neither biodegradable nor absorbable, to allow permanent and lasting diffusion of the liquid to be evacuated; - be neither reactogenic nor irritant to not favor any local fibrosis reaction, hampering the effectiveness of the device in the medium term;
- être bien sûr biocompatibles, c'est-à-dire bien tolérés par l'organisme humain ou animal, sans aucune forme de toxicité locale ou générale ; avoir une surface particulièrement lisse, c'est-à-dire ne présenter aucune aspérité ou irrégularité majeure par une observation au microscope électronique par exemple.- of course be biocompatible, that is to say well tolerated by the human or animal organism, without any form of local or general toxicity; have a particularly smooth surface, that is to say exhibit no major roughness or irregularity by observation with an electron microscope for example.
Les hydrogels et plus généralement tout matériau employé dans les reins artificiels constituent des matériaux préférés pour l'obtention du ou des tubes appartenant à un dispositif selon l'invention.Hydrogels and more generally any material used in artificial kidneys constitute preferred materials for obtaining the tube or tubes belonging to a device according to the invention.
Les hydrogels ou "gels contenant de l'eau", sont des polymères synthétiques absorbant de l'eau, de consistance douce mais ferme induite par leur hydrophilie et leur insolubilité dans l'eau. Ces hydrogels sont obtenus par copolymérisation de monomères ayant des groupements solubilisant l'eau, par exemple hydroxyle, avec d'autres monomères, par exemple l'éthylène-diméthacrylate. Ces hydrogels sont très largement employés en ophtalmologie, par exemple pour des pansements cornéens.The hydrogels or "gels containing water", are synthetic polymers absorbing water, of soft but firm consistency induced by their hydrophilicity and their insolubility in water. These hydrogels are obtained by copolymerization of monomers having water-solubilizing groups, for example hydroxyl, with other monomers, for example ethylene dimethacrylate. These hydrogels are widely used in ophthalmology, for example for corneal dressings.
Pour l'application selon l'invention, à savoir l'obtention de tubes ou tubules, les hydrogels se sont révélés bien adaptés, puisque leur hydrophilie permet d'absorber l'eau, tout en sOpposant à une migration des cellules et des grosses molécules (PM supérieur à 40000 Dalton) . Par ailleurs, ils présentent une bonne perméabilité à l'oxygène, sont transparents optiquement, et se sont révélés durables au plan mécanique.For the application according to the invention, namely obtaining tubes or tubules, the hydrogels have proved to be well suited, since their hydrophilicity makes it possible to absorb water, while opposing a migration of cells and large molecules (PM greater than 40000 Dalton). Furthermore, they have good oxygen permeability, are optically transparent, and have been found to be mechanically durable.
Comme hydrogel, l'acrylonitrile/sodium méthallyl- sulfonate est préféré comme présentant, en particulier, une grande perméabilité vis-à-vis des liquides, propre à assurer une filtration importante en matière de glaucome. Sa biocompatibilité est excellente, puisqu'en particulier, il est la plus hémo-compatible des fibres à haut flux connues pour rein artificiel.As hydrogel, acrylonitrile / sodium methallyl sulfonate is preferred as having, in particular, a high permeability towards liquids, capable of ensuring a significant filtration in glaucoma. Her Biocompatibility is excellent, since in particular it is the most hemo-compatible of the high flux fibers known for artificial kidney.
A titre d'exemple d'un tel matériau, on se rapportera à la référence commerciale AN69 vendue par la Société française HOSPAL.As an example of such a material, reference will be made to the commercial reference AN69 sold by the French company HOSPAL.
Avec ce dernier matériau, comprenant en poids 30 % de polymères non réticulés et 70 % d'eau, selon l'invention, on a obtenu et utilisé des tubes ayant un diamètre extérieur de 340 microns, un diamètre intérieur de 240 microns, et par conséquent, une paroi de 50 microns d'épaisseur. Ces tubes sont glycérines avant leur utilisation, présentent une grande perméabilité, par exemple de l'ordre de 60 ml/h/m2/mm de Hg, grâce à un diamètre extérieur de pore inférieur à 100 Angstrôms.With this latter material, comprising by weight 30% of non-crosslinked polymers and 70% of water, according to the invention, tubes and tubes with an outside diameter of 340 microns, an inside diameter of 240 microns were obtained and used, and by Consequently, a wall 50 microns thick. These tubes are glycerins before their use, have a high permeability, for example of the order of 60 ml / h / m 2 / mm of Hg, thanks to an outside pore diameter of less than 100 Angstroms.
L'état de la surface de ces fibres en hydrogel, déjà satisfaisant au moment de leur obtention, peut être encore amélioré par un traitement de surface approprié, par exemple avec un traitement à température ambiante, en une ou plusieurs étapes, avec un alcool à longue chaîne aliphatique avec des séquences à températures différentes.The surface condition of these hydrogel fibers, already satisfactory when they are obtained, can be further improved by an appropriate surface treatment, for example with treatment at room temperature, in one or more stages, with a long aliphatic chain with sequences at different temperatures.
La présente invention est maintenant décrite par référence aux dessins annexés, dans lesquels :The present invention is now described with reference to the accompanying drawings, in which:
- la figure 1 représente une vue anatomique en coupe d'un oeil et du volet scierai, par rapport auxquels un dispositif selon l'invention est implanté ; les figures 2, 3, 4 représentent, en correspondance avec la figure 1, le globe oculaire avec le volet scierai, sous lequel un dispositif selon l'invention est implanté ;- Figure 1 shows an anatomical sectional view of an eye and the sawdust flap, with respect to which a device according to the invention is implanted; Figures 2, 3, 4 show, in correspondence with Figure 1, the eyeball with the sawdust flap, under which a device according to the invention is implanted;
- la figure 5 représente de manière agrandie, et avec arrachement partiel, un tube de drainage faisant partie du dispositif représenté aux figures 1 et 2, les pores étant généralement invisibles à l'oeil nu. Une fois implanté dans l'oeil et la cavité oculaire 3, le dispositif 1 selon l'invention permet d'évacuer l'humeur aqueuse de la chambre oculaire antérieure 4 vers la coque sclérale 5. Ce dispositif comprend ici une pluralité de tubes de drainage 6, dont l'extrémité amont ou antérieure 6a est implantée dans la chambre antérieure 4 et dont l'autre extrémité avale ou postérieure 6b est implantée sous la conjonctive 11 au-delà du volet scierai 8, la référence 9 représentant la sclère et/ou choroïde. Chaque tube est réalisé en un matériau biocompatible avec l'oeil, en particulier en un matériau hydrophile susceptible d'être mouillé par l'humeur aqueuse, par exemple hydrogel, et présente en même temps une souplesse suffisante pour s'adapter à la forme de la coque sclérale 5 et du globe oculaire. Comme montré par les figures 1 et 5 ensemble, chaque tube 6 comprend, au moins dans sa partie sclérotique 6c, c'est-à-dire dans sa partie disposée après implantation sous le volet scierai 8, et dans la chambre antérieure 4, une porosité ou une multiplicité de micro-perforations 6d traversant sa paroi de part en part, et distribuées dans toute sa surface latérale. Les tubes poreux vont des ouvertures inférieures au micron, pour éviter tout envahissement cellulaire.- Figure 5 shows in an enlarged manner, and with partial cutaway, a drainage tube forming part of the device shown in Figures 1 and 2, the pores being generally invisible to the naked eye. Once implanted in the eye and the ocular cavity 3, the device 1 according to the invention makes it possible to evacuate the aqueous humor from the anterior ocular chamber 4 towards the scleral shell 5. This device here comprises a plurality of drainage tubes 6, whose upstream or anterior end 6a is implanted in the anterior chamber 4 and whose other downstream or posterior end 6b is implanted under the conjunctiva 11 beyond the sawdust flap 8, the reference 9 representing the sclera and / or choroid. Each tube is made of a material biocompatible with the eye, in particular of a hydrophilic material capable of being wetted by the aqueous humor, for example hydrogel, and at the same time has sufficient flexibility to adapt to the shape of the scleral shell 5 and the eyeball. As shown in Figures 1 and 5 together, each tube 6 comprises, at least in its sclerotic part 6c, that is to say in its part disposed after implantation under the sawdust flap 8, and in the anterior chamber 4, a porosity or a multiplicity of micro-perforations 6d passing through its wall right through, and distributed throughout its lateral surface. The porous tubes v have openings less than one micron, to avoid any cellular invasion.
Selon les cas, un seul tube peut suffir, mais en règle générale et pour bien réguler le drainage, on utilisera avantageusement de 3 à 7 tubes en moyenne par oeil.Depending on the case, a single tube may suffice, but as a general rule and to properly regulate drainage, 3 to 7 tubes will be used on average per eye.
Comme montré par la figure 3, le ou les tubes de drainage sont implantés dans l'oeil, après découpe d'un volet scierai 8, lequel est ensuite remis en place par couture selon figure 3, l'acte chirurgical correspondant étant décrit ci-après.As shown in FIG. 3, the drainage tube or tubes are implanted in the eye, after cutting a sawdust flap 8, which is then replaced by sewing according to FIG. 3, the corresponding surgical act being described below. after.
Comme déjà indiqué, chacun des tubes 6 peut être remplacé par une fibre creuse semi-perméable, telle que celles qui sont utilisées dans les dispositifs de dialyse rénale, c'est-à-dire réalisées en un matériau semi-perméable, par exemple un polymère micro-poreux, tel que les fibres creuses ou hydrogels.As already indicated, each of the tubes 6 can be replaced by a semi-permeable hollow fiber, such as those used in renal dialysis devices, that is to say made of a semi-permeable material, for example a micro-porous polymer, such as hollow fibers or hydrogels.
Un mode de réalisation de la présente invention est maintenant décrit, avec un ou plusieurs tubes présentant chacun des micro-perforations, ou une microporosité.An embodiment of the present invention is now described, with one or more tubes each having micro-perforations, or a microporosity.
Un tube de drainage selon l'invention est preferentiellement livré stérile prêt à l'emploi et est implanté en quelques minutes, sous microscope, pendant 1' intervention.A drainage tube according to the invention is preferably delivered sterile ready for use and is implanted in a few minutes, under a microscope, during the intervention.
Le tube de drainage est ensuite coupé obliquement à ses deux extrémités pour permettre, dans la chambre antérieure, une zone de prélèvement à son extrémité amont de l'humeur aqueuse, plus large, et pour éviter plus facilement tout contact endothelial, par une rotation adaptée au tube. A son extrémité avale, la découpe est identique, tant pour que le tube puisse, le cas échéant, être retourné au moment de l'implantation, que pour permettre un contact postérieur aussi doux et harmonieux que possible.The drainage tube is then cut obliquely at its two ends to allow, in the anterior chamber, a sampling zone at its wider upstream end of the aqueous humor, and to more easily avoid any endothelial contact, by suitable rotation to the tube. At its downstream end, the cut is identical, both so that the tube can, if necessary, be turned over at the time of implantation, as to allow posterior contact as smooth and harmonious as possible.
La stérilisation du tube de drainage ajouré peut être effectuée :The sterilization of the perforated drainage tube can be carried out:
1) soit directement à partir d'un tube livré stérile en début d'intervention,1) either directly from a tube delivered sterile at the start of the intervention,
2) soit après rinçage du tube dans un bac à ultra-sons, avec un produit antiseptique et biocompatible ; cette procédure requiert habituellement 48 heures, mais peut être remplacée par une des procédures applicables au silicone ;2) either after rinsing the tube in an ultrasonic tank, with an antiseptic and biocompatible product; this procedure usually requires 48 hours, but can be replaced by one of the procedures applicable to silicone;
3) soit après exposition à des vapeurs d'oxyde d'éthylène ou d'Aldhylène (nom commercial) .3) either after exposure to vapors of ethylene oxide or Aldethylene (trade name).
La mise en place du tube de drainage se fait au cours d'une simple trabéculectomie ou d'une trépanotrabulectomie pratiquée au trépan d'Elliot de 1,7 mm, de façon à pouvoir insérer facilement le tube de drainage (de 0,7 mm de diamètre ou moins si trois fibres de polymère d'acrylonitrile ou dérivé sont utilisées) , dans un orifice arrondi légèrement plus grand. Le tube de drainage est ensuite glissé sous la conjonctive de façon radiaire, vers l'équateur du globe qu'il doit dépasser vers l'arrière.The drainage tube is put in place during a simple trabeculectomy or trepanotrabulectomy performed with 1.7 mm Elliot drill bit, so that the drainage tube (0.7 mm) can be easily inserted diameter or less if three polymer fibers acrylonitrile or derivative are used), in a slightly larger rounded orifice. The drainage tube is then slid under the conjunctiva in a radial fashion, towards the equator of the globe which it must exceed behind.
La fixation du tube de drainage peut être réalisée sous le volet scierai, soit par un point séparé avec un fil de prolène 10/0 (0,2) en préplaquant le pont dans la sclère et en faisant un "tour mort" autour du tube, soit simplement par fermeture de la trappe sclérale, quitte à avoir fabriqué une sangle de passage pour le tubule plus loin sur la coque oculaire. Avant de serrer tout point éventuel, il est important de s'assurer, pour mieux protéger l'endothélium cornéen, que :The drainage tube can be fixed under the sawdust shutter, either by a separate point with a 10/0 prolene wire (0.2) by plating the bridge into the sclera and making a "dead turn" around the tube , or simply by closing the scleral flap, even if it has produced a passage strap for the tubule further on the ocular shell. Before tightening any possible point, it is important to ensure, to better protect the corneal endothelium, that:
1) la longueur qui émerge dans la chambre antérieure soit de 2 mm environ,1) the length which emerges in the anterior chamber is approximately 2 mm,
2) la section oblique de l'extrémité amont ou antérieure du tube soit tournée vers le haut, c'est-à-dire que l'espace entre l'endothélium et le tube de drainage aille croissant vers la pupille, du fait de la section oblique de l'extrémité amont.2) the oblique section of the upstream or anterior end of the tube is turned upwards, that is to say that the space between the endothelium and the drainage tube increases towards the pupil, due to the oblique section of the upstream end.
A titre indicatif et en relation avec la figure 2 représentant un oeil humain dont la cornée a un diamètre d'environ 12 mm, la longueur des tubes autour du point 10 de leur réunion en faisceau est comprise entre 4 et 5 mm et leur partie postérieure 6c s'étend par exemple sur une longueur comprise entre 8 et 24 mm.By way of indication and in relation to FIG. 2 representing a human eye whose cornea has a diameter of approximately 12 mm, the length of the tubes around the point 10 of their bundling is between 4 and 5 mm and their posterior part 6c extends for example over a length of between 8 and 24 mm.
La fermeture conjonctivale est ensuite pratiquée de façon tout-à-fait classique, selon l'habitude du chirurgien, en sachant qu'une ouverture à distance du limbe semble plus adaptée. Ainsi, l'implantation d'un dispositif de drainage performant n'a représenté qu'un complément simple et facile à adjoindre à un protocole chirurgical classique : "la trabéculectomie" .Conjunctival closure is then practiced in a completely classic way, according to the surgeon's habit, knowing that an opening at a distance from the limbus seems more suitable. Thus, the implantation of an efficient drainage device represented only a simple and easy complement to add to a traditional surgical protocol: "trabeculectomy".
Ce même type de dispositif de drainage peut être introduit de façon comparable dans l'espace où circule le liquide céphalo-rachidien éventuellement en surpression vers le tissu conjonctif avoisinant. This same type of drainage device can be introduced in a comparable way into the space where the cerebrospinal fluid possibly overpressure to the surrounding connective tissue.

Claims

REVENDICATIONS
1. Dispositif (1) implantable dans tout organisme vivant humain ou animal, destiné à évacuer tout liquide d'une collection oedémateuse comprenant au moins un tube de drainage (6) dont une extrémité (6a) dite amont est destinée à être implantée dans la cavité séreuse en surpression et dont une autre extrémité (6b) dite avale est destinée à être implantée dans une zone d'évacuation, le tube présentant au moins en partie une souplesse suffisante pour s'adapter à la forme de la partie dans laquelle il est implanté, et étant réalisé en au moins un matériau biocompatible, caractérisé en ce que le tube présente sur la majeure partie de sa longueur entre son extrémité amont (6a) et son extrémité avale (6b) , et notamment dans la partie destinée à être en relation avec la zone d'évacuation, une perméabilité latérale permettant une diffusion de la quasi-totalité du liquide prélevé par son extrémité amont (6a), de l'intérieur vers l'extérieur et par la paroi dudit tube, mais s'opposant à une migration cellulaire de l'extérieur vers l'intérieur dudit tube, et en ce que le tube n'est pas totalement en position intrasclérale.1. Device (1) implantable in any living human or animal organism, intended to evacuate any liquid from an edematous collection comprising at least one drainage tube (6), one end (6a) of which is called upstream and is intended to be implanted in the serous cavity in overpressure and of which another end (6b) called downstream is intended to be implanted in an evacuation zone, the tube having at least partly sufficient flexibility to adapt to the shape of the part in which it is implanted, and being made of at least one biocompatible material, characterized in that the tube has over most of its length between its upstream end (6a) and its downstream end (6b), and in particular in the part intended to be in relation to the discharge zone, a lateral permeability allowing diffusion of almost all the liquid withdrawn by its upstream end (6a), from the inside to the outside and by the wall of said tube, but opposing cell migration from the outside to the inside of said tube, and in that the tube is not completely in the intrascleral position.
2. Dispositif selon la revendication 1, caractérisé en ce qu'il est destiné à évacuer l'humeur aqueuse de la chambre oculaire antérieure (4) vers la coque sclérale (5) et qu'il comprend au moins un tube (6) dont l'extrémité (6a) amont est destinée à être implantée dans la chambre antérieure (4) de l'oeil et dont l'autre extrémité (6b) avale est destinée à être implantée sous la conjonctive au-delà du volet scierai (8) .2. Device according to claim 1, characterized in that it is intended to evacuate the aqueous humor from the anterior ocular chamber (4) towards the scleral shell (5) and that it comprises at least one tube (6) of which the upstream end (6a) is intended to be implanted in the anterior chamber (4) of the eye and the downstream other end (6b) of which is intended to be implanted under the conjunctiva beyond the sawdust flap (8) .
3. Dispositif selon la revendication 1 ou 2, caractérisé en ce que le matériau du tube (6) de drainage est continu mais semi-perméable, au moins de l'intérieur vers l'extérieur, et permet une diffusion continue dans le même sens, du liquide à évacuer. 3. Device according to claim 1 or 2, characterized in that the material of the drainage tube (6) is continuous but semi-permeable, at least from the inside to the outside, and allows continuous diffusion in the same direction , liquid to drain.
4. Dispositif selon la revendication 1 ou 2, caractérisé en ce qu'il comprend une pluralité de tubes de drainage (6) , indépendants les uns des autres, ou reliés les uns aux autres par un moyen de solidarisation à plat.4. Device according to claim 1 or 2, characterized in that it comprises a plurality of drainage tubes (6), independent of each other, or connected to each other by means of fastening flat.
5. Dispositif selon la revendication 1 ou 2, caractérisé en ce que l'extrémité avale (6b) du tube de drainage (6) est ouverte.5. Device according to claim 1 or 2, characterized in that the downstream end (6b) of the drainage tube (6) is open.
6. Dispositif selon la revendication 1 ou 2, caractérisé en ce que le matériau du tube de drainage (6) est preferentiellement hydrophile, mais peut être choisi parmi le silicone, le polyméthacrylate de méthyle, le polyvinyldifluoroéthylène, et les hydrogels, les produits dérivés de produits cellulosiques, les produits de type éthylène/vinyle alcool, polyméthyl-méthacrylate, et preferentiellement polyacrylonitrile simple ou couplé au sodium méthallyl-sulfonate, polysulfone et toute autre combinaison permettant de réaliser un tubule poreux, ou parmi les produits rigides comme une céramique poreuse et en particulier une alumine simple, une zircone-alumine et une zircone tétragonale.6. Device according to claim 1 or 2, characterized in that the material of the drainage tube (6) is preferentially hydrophilic, but can be chosen from silicone, polymethyl methacrylate, polyvinyldifluoroethylene, and hydrogels, derived products cellulosic products, ethylene / vinyl alcohol, polymethyl methacrylate, and preferably polyacrylonitrile simple or coupled to sodium methallyl-sulfonate, polysulfone and any other combination making it possible to produce a porous tubule, or among rigid products such as a porous ceramic and in particular a simple alumina, a zirconia-alumina and a tetragonal zirconia.
7. Dispositif selon la revendication 1, caractérisé en ce que le tube de drainage est en polyacrylonitrile/sodium méthallyl-sulfonate.7. Device according to claim 1, characterized in that the drainage tube is made of polyacrylonitrile / sodium methallyl-sulfonate.
8. Dispositif selon la revendication 1, caractérisé en ce que le tube de drainage est une fibre creuse poreuse, notamment dont la porosité est comprise entre 10 et 95 %.8. Device according to claim 1, characterized in that the drainage tube is a porous hollow fiber, in particular whose porosity is between 10 and 95%.
9. Dispositif selon la revendication 1, caractérisé en ce que le tube de drainage est une fibre creuse, notamment ayant un diamètre compris entre 0,3 et 1,8 mm, avec une épaisseur de la paroi de plus de 50 micromètres.9. Device according to claim 1, characterized in that the drainage tube is a hollow fiber, in particular having a diameter between 0.3 and 1.8 mm, with a wall thickness of more than 50 micrometers.
10. Dispositif selon la revendication 1, caractérisé en ce que les pores du tube de drainage ont un diamètre moyen inférieur à 100 Angstrôms. 10. Device according to claim 1, characterized in that the pores of the drainage tube have an average diameter less than 100 Angstroms.
PCT/IB1994/000284 1993-09-22 1994-09-20 Implantable device for the treatment of ×demas WO1995008310A1 (en)

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FR93/11476 1993-09-22
FR9311476A FR2710269A1 (en) 1993-09-22 1993-09-22 Implantable device for the treatment of edemas.

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