WO2010116338A1 - Infusion chamber for a cornea - Google Patents

Infusion chamber for a cornea Download PDF

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Publication number
WO2010116338A1
WO2010116338A1 PCT/IB2010/051521 IB2010051521W WO2010116338A1 WO 2010116338 A1 WO2010116338 A1 WO 2010116338A1 IB 2010051521 W IB2010051521 W IB 2010051521W WO 2010116338 A1 WO2010116338 A1 WO 2010116338A1
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WIPO (PCT)
Prior art keywords
cornea
chamber according
perfusion
chamber
infusion chamber
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PCT/IB2010/051521
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French (fr)
Inventor
Marc Pericoi
François POUZAUD
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Peritesco
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Publication of WO2010116338A1 publication Critical patent/WO2010116338A1/en

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    • A—HUMAN NECESSITIES
    • A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
    • A01N—PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
    • A01N1/00—Preservation of bodies of humans or animals, or parts thereof
    • A01N1/02—Preservation of living parts
    • A01N1/0236—Mechanical aspects
    • A01N1/0263—Non-refrigerated containers specially adapted for transporting or storing living parts whilst preserving, e.g. cool boxes, blood bags or "straws" for cryopreservation
    • A—HUMAN NECESSITIES
    • A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
    • A01N—PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
    • A01N1/00—Preservation of bodies of humans or animals, or parts thereof
    • A01N1/02—Preservation of living parts
    • A01N1/0236—Mechanical aspects
    • A01N1/0242—Apparatuses, i.e. devices used in the process of preservation of living parts, such as pumps, refrigeration devices or any other devices featuring moving parts and/or temperature controlling components
    • A01N1/0247—Apparatuses, i.e. devices used in the process of preservation of living parts, such as pumps, refrigeration devices or any other devices featuring moving parts and/or temperature controlling components for perfusion, i.e. for circulating fluid through organs, blood vessels or other living parts

Definitions

  • the present invention relates to an infusion chamber for cornea comprising a sealed chamber adapted to receive a cornea. It is necessary, during the process of validation of many products, to determine the toxicity of these products for the human eye. So far, many tests have been performed on live animals, in order to seek to predict the impact of such products on a human eye.
  • the cornea can not be positioned vertically and no circulation of tear fluid on the outer surface of the cornea is expected which does not allow to take into account the lacrimal dynamics.
  • perfusion is performed only on the inner face of the cornea.
  • the device does not allow the direct observation of the cornea by a clinical method as well as the observation of the reversibility of the toxicological effects. Moreover, the system is not sterile and does not take into account the lacrimal dynamics.
  • a cornea infusion chamber comprising a ⁇ tanche enclosure adapted to receive a cornea, is characterized in that it comprises means adapted to maintain the shape of the cornea when the enclosure is arranged so that the surface internal of the cornea is vertical.
  • the method may include a step in which conjunctival cells are added to the cornea.
  • Fig. 1 is a perspective view of an infusion chamber according to the invention
  • Fig. 2 is a view similar to FIG. 1 from a different point of view.
  • Fig. 3 is a cross-sectional view illustrating the internal structure of the chamber of FIG. 1 and 2.
  • Fig. 5 is a perspective view of the front of the intermediate portion of the chamber of FIG. 1 and 2.
  • Fig. 6 is a perspective view of the rear of the intermediate portion of the chamber of FIG. 1 and 2.
  • Fig. 7 is a perspective view of the front of the rear portion of the chamber of FIG. 1 and 2 illustrating the system where the cornea will be deposited.
  • Fig. 8 is a perspective view of the rear of the rear portion of the chamber of FIG. 1 and 2 illustrating the point of injection or casting of the gel for maintaining the cornea, and
  • the three parts 1, 2 and 3 are integrally held together by means of six screws 4 and 5.
  • the three screws 4 fix and tighten the front part 1 (FIG 4) on the intermediate part 2 (FIGS. 6).
  • the positioning in rotation of the parts relative to each other is facilitated by the flattened M.
  • the three screws 4 also maintain the sealing by pressing the glass 6 and the seal 7, made of silicone and interposed between the glass 6 and the intermediate part 2, which are placed between the front part 1 and the intermediate part 2, FIG. 3.
  • the three screws 5 have screw heads embedded in the front part 1 and serve to hold the intermediate part 2 with the rear part 3.
  • the screw heads also serve as a guide for adapting the front part 1 (FIG. on the intermediate part 2 (figures 5 and 6).
  • FIG. 4 the six screw holes 4 and 5 and a central chanfine recess 10 to improve the observation and access to the cornea.
  • This front part 1 makes it possible to tighten the window 6, which presses on the silicone seal 7 to guarantee the tightness of the hollow circular space of the intermediate part 2.
  • the tightness of the internal space of the device makes it possible to work under sterile conditions and contributes to the preservation of the viability of the cornea in the long term. Under non-sterile conditions, it is difficult to study the cornea more than a few hours, that is to say in general 4 or 5 hours. hours. By sealing the device and working under sterile conditions, it is possible to keep the cornea alive for several days.
  • the use of the device according to the invention can achieve a life of one week. A corneal life of 21 days does not seem an unrealistic goal.
  • FIG. 5 and 6 the three threaded holes of the screws 4 for clamping the front portion 1 on the intermediate portion 2 and three holes unthreaded tapped screws 5 for clamping the three parts 1, 2, 3 together.
  • a central circular recess in the intermediate part 2 comprising a first countersink 11 on which rests the elaborate silicone seal 8 and the transparent circular pane 6 and a second counter-sill 12 wider to deposit different cell types and on the edge from which the six through holes 9 open.
  • the holes 9 allow to inject rinsing liquid and / or survival at the cornea. This recreates a tear dynamic by simulating a tear flow on the cornea. This possibility allows to get closer to the real conditions in which is a cornea.
  • the hole 9 located at the highest altitude when the cornea is vertical can be used to inject products whose effects on the cornea are to be characterized.
  • the holes 9 also allow the sampling of the circulating liquid in the device in particular to assay biological markers in this liquid.
  • a circular recess 13 in the intermediate part 2 allows the cornea to open directly into the internal recess of part 2.
  • a circular opening opening and chamfered 17 of the rear part of the invention allows the retrograde flow of the structural gel of the cornea during its casting or its injection using the tapped hole and opening 18.
  • This recess also allows the taking of gel samples so as to study the evolution of its composition to perform corneal permeability studies. Indeed a permeability of the cornea will cause the passage of elements present in the liquid flowing in the device through the cornea to the gel structure. An analysis of this gel thus makes it possible to detect and quantify this permeability.
  • the hole 18 comprises a countersink 19, which allows to introduce and fix a screw to maintain the sterility of the assembly and to access the inner face of the cornea.
  • Fig. 9 illustrates a support support 20 made of polypropylene and used to position the perfusion chamber directly on a biomicroscope to study clinically the cornea.
  • the base is provided with two unthreaded through holes 21 for introducing two pins 22 to hold the support on the biomicroscope.
  • the platform 23 comprises two borders framing a grooved central portion. One of the borders is equipped with a screw 24 for clamping and maintaining the invention.
  • the presence of the window 6 allows access to the cornea for observation and / or ophthalmological examination.
  • the vertical position of the cornea is of great importance here and makes it possible to place a living cornea in the sterile device in front of a conventional ophthalmological observation device, a microscope or a slit lamp.
  • the device also allows the study of contact lenses and in particular their resistance to cosmetics and agglomerates formed by them.

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  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Health & Medical Sciences (AREA)
  • Dentistry (AREA)
  • Mechanical Engineering (AREA)
  • General Health & Medical Sciences (AREA)
  • Wood Science & Technology (AREA)
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Abstract

The invention relates to an infusion chamber for a cornea including a sealed chamber (1, 2, 3, 6) capable of receiving a cornea, characterized in that it includes means for retaining the shape of the cornea when the chamber is arranged such that the inner surface of the cornea is vertical.

Description

CHAMBRE DE PERFUSION POUR CORNEE INFUSION CHAMBER FOR CORNEA
La présente invention est relative à une chambre de perfusion pour cornée comprenant une enceinte étanche apte à recevoir une cornée. II est nécessaire, lors du processus de validation de nombreux produits, de déterminer la toxicité de ces produits pour l'œil humain. Jusqu'à présent, de nombreux tests ont été effectues sur des animaux vivants, dans le but de chercher à prévoir l'impact de tels produits sur un œil humain.The present invention relates to an infusion chamber for cornea comprising a sealed chamber adapted to receive a cornea. It is necessary, during the process of validation of many products, to determine the toxicity of these products for the human eye. So far, many tests have been performed on live animals, in order to seek to predict the impact of such products on a human eye.
Néanmoins, de tels tests sont de moins en moins acceptables et il est nécessaire de les éviter au maximum.Nevertheless, such tests are less and less acceptable and it is necessary to avoid them as much as possible.
Diverses tentatives ont été fartes pour effectuer différents types de tests sur des cornées prélevées sur des animaux.Various attempts have been made to perform different types of tests on corneas taken from animals.
Isabelle Brunette, Leif R. Nelson et William M. Bourne dans « AIsabelle Brunette, Leif R. Nelson and William M. Bourne in "A
System for long-term corneal perfusion » 1989, Investigative ophthalmology and visual science, Vol. 30, N° 8, présentent l'utilisation d'une chambre de perfusion stérile de cornées humaines dans un but de conservation et de préservation de la cornée.System for long-term corneal perfusion "1989, Investigative ophthalmology and visual science, Vol. 30, No. 8, disclose the use of a sterile perfusion chamber of human corneas for the purpose of preservation and preservation of the cornea.
La cornée ne peut pas être positionnée verticalement et aucune circulation de fluide lacrymal sur la surface externe de la cornée n'est prévue ce qui ne permet pas de prendre en compte la dynamique lacrymale.The cornea can not be positioned vertically and no circulation of tear fluid on the outer surface of the cornea is expected which does not allow to take into account the lacrimal dynamics.
Il n'y a pas non plus d'application toxicologique ou de mesure de l'irritation oculaire ou de la réversibilité des atteintes cornéennes.There is also no toxicological application or measurement of ocular irritation or reversibility of corneal involvement.
MA Thiel, N Morlet, D Shultz, HF Edelhauser, JK Dart, DJ Coster etMA Thiel, Morlet N, D Shultz, Edelhauser HF, JK Dart, DJ Coster and
KA Williams dans « A simple corneal perfusion chamber for drug pénétration and toxicity studies » 2001 , British Journal of Ophthalmology, 85:450-453, présentent un dispositif similaire utilisant un système clos de perfusion ne permettant pas une utilisation du système à la verticale.KA Williams in "A simple Corneal Perfusion Chamber for Drug Penetration and Toxicity Studies" 2001, British Journal of Ophthalmology, 85: 450-453, disclose a similar device using a closed perfusion system that does not allow the system to be used vertically.
Il y a une application toxicologique mais sans aucune observation clinique et aucune circulation de fluide lacrymal sur la surface externe de la cornée n'est prévue ce qui ne permet pas de prendre en compte la dynamique lacrymale.There is a toxicological application but without any clinical observation and no circulation of tear fluid on the outer surface of the cornea is provided which does not allow to take into account the tear dynamics.
On peut noter également que la perfusion n'est réalisée que sur la face interne de la cornée.It may also be noted that perfusion is performed only on the inner face of the cornea.
Van den Berghe C, Guillet MC et Compan D dans « Performance of porcine comeal opacity and permeability assay to predict eye irritation for water- soluble cosmetic ingrédients » 2005, Toxicology In Vitro 19:823-830, présentent un travail utilisant un système clos de perfusion ne maintenant pas la cornée dans sa forme naturelle.Van den Berghe C, Guillet TM and Compan D in "Performance of porcine comeal opacity and permeability assay to predict eye irritation for water- soluble cosmetic ingredients" 2005, Toxicology In Vitro 19: 823-830, present a work using a closed system of infusion does not now the cornea in its natural form.
Le support est vertical uniquement lors de la lecture et non pendant la phase d'application du produit.The media is vertical only during playback and not during the application phase of the product.
On peut remarquer que le dispositif ne permet pas l'observation directe de la cornée par une méthode clinique ainsi que l'observation de la réversibilité des effets toxicologiques. Par ailleurs le système n'est pas stérile et ne permet pas de prendre en compte la dynamique lacrymale.It may be noted that the device does not allow the direct observation of the cornea by a clinical method as well as the observation of the reversibility of the toxicological effects. Moreover, the system is not sterile and does not take into account the lacrimal dynamics.
Frentz M, Goss M1 Reim M, Schrage NF. 2008. Repeated exposure to BAK in the Ex Vivo Irritation Test (EVEIT): Observation of isolated corneal damage and healing, ATLA, 36, 25-32.Frentz M, Goss M 1 Reim M, Schrage NF. 2008. Repeated Exposure to BAK in the Ex Vivo Irritation Test (EVEIT): ATLA, 36, 25-32.
Ce système utilise une chambre de perfusion pour réaliser une irrigation sur la face interne de la cornée en maintenant le modèle horizontal. La cinétique lacrymale n'est pas reproduite. Une approche ophtalmologique est utilisée pour visualiser l'atteinte toxique mais de manière qualitative. Aucun système à ce jour ne permet d'effectuer des tests, la cornée étant dans un état et une position proche des conditions réelles. En particulier, les cornées sont toujours déposées horizontalement sur leur support. Dans un tel cas la cornée se déforme sous son propre poids et il est de plus impossible de la redresser pour la placer dans une situation proche de la réalité. En effet lorsqu'un individu reçoit malencontreusement des projections du liquide à tester, il est rarement couché mais le plus souvent debout. De plus une projection de produit sur la cornée va provoquer une réaction lacrymale qu'il convient de prendre en compte lors des tests. Il est donc nécessaire de concevoir un dispositif permettant de placer la cornée dans un nombre varié de position, tout en préservant au maximum sa forme, le dispositif permettant également de simuler un écoulement lacrymal.This system uses an infusion chamber to perform irrigation on the inner side of the cornea by maintaining the horizontal model. The lacrimal kinetics are not reproduced. An ophthalmological approach is used to visualize the toxic attack but in a qualitative way. No system to date allows to perform tests, the cornea being in a state and a position close to real conditions. In particular, the corneas are always deposited horizontally on their support. In such a case the cornea is deformed under its own weight and it is moreover impossible to straighten it to put it in a situation close to reality. Indeed, when an individual inadvertently receives projections of the liquid to be tested, it is rarely lying but most often standing. In addition a projection of product on the cornea will cause a tear reaction that should be taken into account during testing. It is therefore necessary to design a device for placing the cornea in a varied number of positions, while preserving its shape as much as possible, the device also making it possible to simulate a lacrimal flow.
Le dispositif selon l'invention a notamment pour but de répondre aux besoins mentionnés ci-dessus.The device according to the invention is intended in particular to meet the needs mentioned above.
Selon l'invention une chambre de perfusion pour cornée comprenant une enceinte όtanche apte à recevoir une cornée, est caractérisée en ce qu'elle comprend des moyens aptes à maintenir la forme de la cornée lorsque l'enceinte est disposée de telle sorte que la surface interne de la cornée soit verticale.According to the invention a cornea infusion chamber comprising a όtanche enclosure adapted to receive a cornea, is characterized in that it comprises means adapted to maintain the shape of the cornea when the enclosure is arranged so that the surface internal of the cornea is vertical.
Avantageusement, la chambre de perfusion comprend des moyens d'injection d'un gel dans la cornée.Advantageously, the perfusion chamber comprises means for injecting a gel into the cornea.
Les moyens d'injection peuvent comprendre un orifice d'injection. La chambre de perfusion peut comprendre des moyens d'injection de fluide sur la cornée.The injection means may comprise an injection orifice. The perfusion chamber may comprise means for injecting fluid on the cornea.
Le fluide injecté peut avoir des propriétés irritantes ou être un fluide lacrymal.The injected fluid may have irritating properties or be a lacrimal fluid.
Les moyens d'injection de fluide peuvent comprendre au moins un orifice.The fluid injection means may comprise at least one orifice.
La chambre de perfusion peut comprendre un support conique permettant de faire reposer la cornée.The perfusion chamber may include a conical support for resting the cornea.
La chambre de perfusion peut comporter une paroi latérale cylindrique, l'orifice étant disposé tangentiellement à la paroi latérale cylindrique.The perfusion chamber may comprise a cylindrical side wall, the orifice being disposed tangentially to the cylindrical side wall.
La chambre de perfusion peut comporter une paroi transparente ou une vitre apte à permettre l'observation de la cornée.The perfusion chamber may comprise a transparent wall or a window capable of allowing observation of the cornea.
L'invention concerne également un support de chambre de perfusion, apte à permettre le positionnement d'une chambre de perfusion selon l'une quelconque des revendications 1 à 8 sur un microscopeThe invention also relates to an infusion chamber support, adapted to allow the positioning of an infusion chamber according to any one of claims 1 to 8 on a microscope
Le procédé peut comporter une étape au cours de laquelle on ajoute à la corn ée des cellules conjonctivales.The method may include a step in which conjunctival cells are added to the cornea.
D'autres caractéristiques et avantages de l'invention apparaîtront dans la description qui suit d'un mode de réalisation préféré avec référence aux dessins annexés mais qui n'a aucun caractère limitatif. Sur ces dessins :Other features and advantages of the invention will appear in the following description of a preferred embodiment with reference to the accompanying drawings but which has no limiting character. On these drawings:
Fig. 1 est une vue en perspective d'une chambre de perfusion selon invention,Fig. 1 is a perspective view of an infusion chamber according to the invention,
Fig. 2 est une vue similaire à Fig. 1 suivant un point de vue différent.Fig. 2 is a view similar to FIG. 1 from a different point of view.
Fig. 3 est une vue en coupe transversale illustrant la structure intérieure de la chambre de Fig. 1 et 2.Fig. 3 is a cross-sectional view illustrating the internal structure of the chamber of FIG. 1 and 2.
Fig. 4 est une vue de la partie avant de la chambre de Fig. 1 et 2.Fig. 4 is a view of the front portion of the chamber of FIG. 1 and 2.
Fig. 5 est une vue en perspective de l'avant de la partie intermédiaire de la chambre de Fig. 1 et 2.Fig. 5 is a perspective view of the front of the intermediate portion of the chamber of FIG. 1 and 2.
Fig. 6 est une vue en perspective de l'arrière de la partie intermédiaire de la chambre de Fig. 1 et 2.Fig. 6 is a perspective view of the rear of the intermediate portion of the chamber of FIG. 1 and 2.
Fig. 7 est une vue en perspective de l'avant de la partie arrière de la chambre de Fig. 1 et 2 illustrant le système où sera déposée la cornée.Fig. 7 is a perspective view of the front of the rear portion of the chamber of FIG. 1 and 2 illustrating the system where the cornea will be deposited.
Fig. 8 est une vue en perspective de l'arrière de la partie arrière de la chambre de Fig. 1 et 2 illustrant le point d'injection ou de coulage du gel servant à maintenir la cornée, etFig. 8 is a perspective view of the rear of the rear portion of the chamber of FIG. 1 and 2 illustrating the point of injection or casting of the gel for maintaining the cornea, and
Fig. 9 est une vue en perspective d'un support d'adaptation de la chambre de Fig. 1 et 2 sur un bio-microscope. Dans toute la description qui suit d'un mode de réalisation d'une chambre de perfusion pour cornée selon l'invention, les termes relatifs tels que « supérieur », « inférieur », « avant », « arrière », « horizontal » et « vertical » sont à interpréter, sauf indication contraire, lorsque la chambre de perfusion pour cornée est dressée verticalement, l'axe du trou 18 étant horizontal, la surface interne de la cornée étant verticale. On appelle surface externe de la cornée, la surface faisant face au milieu extérieur et surface interne de la cornée, la surface orientée vers le corps de l'organisme porteur de la cornée avant son prélèvement. Fig. 1 et 2 montrent une chambre de perfusion pour cornée selon l'invention élaborée à partir de polypnopytène et composée de trois parties, une partie avant 1 , une partie intermédiaire 2 et une partie arrière 3, lesquelles sont de forme cylindrique avec un méplat M. La partie avant comporte une ouverture fermée par une vitre 6. Fig. 3 présente une vue en coupe longitudinale de la une chambre de perfusion illustrant l'assemblage des trois parties 1 , 2, 3 avec deux joints de silicone circulaire 7, 8, la vitre 6 et six trous débouchants 9.Fig. 9 is a perspective view of an adaptation support of the chamber of FIG. 1 and 2 on a bio-microscope. Throughout the following description of an embodiment of a cornea perfusion chamber according to the invention, the relative terms such as "upper", "lower", "front", "back", "horizontal" and "Vertical" are to be interpreted, unless otherwise indicated, when the corneal perfusion chamber is erected vertically, the axis of the hole 18 being horizontal, the inner surface of the cornea being vertical. The outer surface of the cornea is called the outer surface and inner surface of the cornea, the surface facing the body of the corneal bearing organism before it is removed. Fig. 1 and 2 show a cornea perfusion chamber according to the invention prepared from polypnopyne and composed of three parts, a front part 1, an intermediate part 2 and a rear part 3, which are cylindrical with a flat M. The front part has an opening closed by a window 6. FIG. 3 shows a longitudinal sectional view of the perfusion chamber illustrating the assembly of the three parts 1, 2, 3 with two circular silicone seals 7, 8, the window 6 and six through holes 9.
Les trois parties 1 , 2 et 3 sont maintenues solidairement entre elles à l'aide de six vis 4 et 5. Les trois vis 4 fixent et serrent la partie avant 1 (fig. 4) sur la partie intermédiaire 2 (fig. 5 et 6). Le positionnement en rotation des parties les unes par rapport aux autres est facilité par le méplat M. Les trois vis 4 maintiennent également Pétanchéité en appuyant sur la vitre 6 et le joint 7, élaboré en silicone et interposé entre la vitre 6 et la partie intermédiaire 2, lesquels sont placés entre la partie avant 1 et la partie intermédiaire 2, Fig. 3. Les trois vis 5 présentent des têtes de vis noyées dans la partie avant 1 et servent à maintenir la partie intermédiaire 2 avec la partie arrière 3. Les têtes des vis servent également de guide pour adapter la partie avant 1 (fig. 4) sur la partie intermédiaire 2 (fig. 5 et 6).The three parts 1, 2 and 3 are integrally held together by means of six screws 4 and 5. The three screws 4 fix and tighten the front part 1 (FIG 4) on the intermediate part 2 (FIGS. 6). The positioning in rotation of the parts relative to each other is facilitated by the flattened M. The three screws 4 also maintain the sealing by pressing the glass 6 and the seal 7, made of silicone and interposed between the glass 6 and the intermediate part 2, which are placed between the front part 1 and the intermediate part 2, FIG. 3. The three screws 5 have screw heads embedded in the front part 1 and serve to hold the intermediate part 2 with the rear part 3. The screw heads also serve as a guide for adapting the front part 1 (FIG. on the intermediate part 2 (figures 5 and 6).
On peut voir Fig. 4 les six trous de vis 4 et 5 ainsi qu'un évidement chanf reine central 10 permettant d'améliorer l'observation et l'accès à la cornée . Cette partie avant 1 permet le serrage de la vitre 6, laquelle vient appuyer sur le joint en silicone 7 pour garantir l'étanchéité de l'espace circulaire évidé de la pièce intermédiaire 2.We can see Fig. 4 the six screw holes 4 and 5 and a central chanfine recess 10 to improve the observation and access to the cornea. This front part 1 makes it possible to tighten the window 6, which presses on the silicone seal 7 to guarantee the tightness of the hollow circular space of the intermediate part 2.
L'étanchéité de l'espace interne du dispositif permet de travailler dans des conditions stériles et contribue à la conservation de la viabilité de la cornée sur le long terme. Dans des conditions non stériles, il est difficile d'étudier la corn ée plus de quelques heures, c'est-à-dire en général 4 ou 5 heures. Grâce à l'étanchόité du dispositif et à un travail dans des conditions stériles, il est possible de garder en vie la cornée pendant plusieurs jours. L'utilisation du dispositif selon l'invention peut permettre d'atteindre une durée de vie d'une semaine. Une durée de vie de la cornée de 21 jours ne semble pas un objectif irréalisable.The tightness of the internal space of the device makes it possible to work under sterile conditions and contributes to the preservation of the viability of the cornea in the long term. Under non-sterile conditions, it is difficult to study the cornea more than a few hours, that is to say in general 4 or 5 hours. hours. By sealing the device and working under sterile conditions, it is possible to keep the cornea alive for several days. The use of the device according to the invention can achieve a life of one week. A corneal life of 21 days does not seem an unrealistic goal.
On peut voir Fig. 5 et 6 les trois trous taraudés des vis 4 permettant le serrage de la partie avant 1 sur la partie intermédiaire 2 et les trois trous débouchant non taraudés des vis 5 permettant le serrage des trois parties 1 , 2, 3 ensemble. On peut voir également un évidβment circulaire central dans la partie intermédiaire 2 comprenant un premier lamage 11 sur lequel repose le joint élaboré en silicone 8 et la vitre circulaire transparente 6 et un second lamage 12 plus large permettant de déposer différents types cellulaires et sur le bord duquel les six trous traversants 9 débouchent. Les trous 9 permettent d'injecter du liquide de rinçage et/ou de survie au niveau de la cornée. Ceci permet de recréer une dynamique lacrymale en simulant un écoulement lacrymal sur la cornée. Cette possibilité permet de se rapprocher des conditions réelles dans laquelle se trouve une cornée. Le trou 9 situé à l'altitude la plus élevée lorsque la cornée est verticale peut être utilisé pour injecter des produits dont on souhaite caractériser les effets sur la cornée.We can see Fig. 5 and 6 the three threaded holes of the screws 4 for clamping the front portion 1 on the intermediate portion 2 and three holes unthreaded tapped screws 5 for clamping the three parts 1, 2, 3 together. We can also see a central circular recess in the intermediate part 2 comprising a first countersink 11 on which rests the elaborate silicone seal 8 and the transparent circular pane 6 and a second counter-sill 12 wider to deposit different cell types and on the edge from which the six through holes 9 open. The holes 9 allow to inject rinsing liquid and / or survival at the cornea. This recreates a tear dynamic by simulating a tear flow on the cornea. This possibility allows to get closer to the real conditions in which is a cornea. The hole 9 located at the highest altitude when the cornea is vertical can be used to inject products whose effects on the cornea are to be characterized.
Il est possible d'injecter simultanément les produits à tester et le fluide lacrymal de manière à reproduire la distribution d'un produit entrant en contact avec la cornée. On rappelle ici que le contact avec la cornée d'un produit agressif provoque généralement un écoulement lacrymal abondant qui influe sur la dispersion du produit agressif à la surface de la cornée. On comprend qu'il est donc important de pouvoir récréer cette dynamique dans le dispositif selon l'invention. Les trous 9 permettent également le prélèvement du liquide circulant dans le dispositif afin notamment de doser des marqueurs biologiques dans ce liquide.It is possible to inject the test products and the tear fluid simultaneously in order to reproduce the distribution of a product coming into contact with the cornea. It is recalled here that the contact with the cornea of an aggressive product generally causes an abundant tear flow which influences the dispersion of the aggressive product on the surface of the cornea. It is understood that it is therefore important to recreate this dynamic in the device according to the invention. The holes 9 also allow the sampling of the circulating liquid in the device in particular to assay biological markers in this liquid.
Enfin, un évidement circulaire 13 dans la partie intermédiaire 2 permet à la cornée de déboucher directement dans l'évidement interne de la partie 2.Finally, a circular recess 13 in the intermediate part 2 allows the cornea to open directly into the internal recess of part 2.
Sur la face extérieure de la partie intermédiaire 2 sont présents deux trous 14 (fig. 5) débouchant dans l'évidement de la partie Intermédiaire 2 au niveau du lamage 12 qui permettent de drainer l'excédant de liquide qui s'accumulera dans l'évidement interne de la partie intermédiaire 2.On the outer face of the intermediate portion 2 there are two holes 14 (FIG 5) opening into the recess of the intermediate portion 2 to level of countersink 12 which drain the excess liquid that will accumulate in the internal recess of the intermediate portion 2.
On peut voir Fig. 7 un épaulement 15 d'étendant à partir de la partie arrière 3 de l'invention. Trois trous taraudés pour les vis 5 sont également visibles. Un second épaulement au centre de la partie arrière 3 comprend un support conique 16 permettant de faire reposer l'anneau sdéral de la cornée et de maintenir celle-ci dans une courbure anatomique naturelle.We can see Fig. 7 a shoulder 15 extending from the rear portion 3 of the invention. Three threaded holes for the screws 5 are also visible. A second shoulder in the center of the rear portion 3 comprises a conical support 16 for resting the sdéral ring of the cornea and maintain it in a natural anatomical curvature.
Au centre de la partie arrière de la chambre de perfusion (Fig. 8) un évidement circulaire débouchant et chanfreiné 17 de la partie arrière de l'invention permet l'écoulement rétrograde du gel de structure de la cornée lors de son coulage ou de son injection à l'aide du trou taraudé et débouchant 18.In the center of the rear part of the infusion chamber (Fig. 8) a circular opening opening and chamfered 17 of the rear part of the invention allows the retrograde flow of the structural gel of the cornea during its casting or its injection using the tapped hole and opening 18.
Cet évidement permet également le prélèvement d'échantillons de gel de manière à étudier l'évolution de sa composition pour réaliser des études de la perméabilité cornôenne. En effet une perméabilité de la cornée va provoquer le passage d'éléments présents dans le liquide circulant dans le dispositif à travers la cornée vers le gel de structure. Une analyse de ce gel permet donc de détecter et de quantifier cette perméabilité.This recess also allows the taking of gel samples so as to study the evolution of its composition to perform corneal permeability studies. Indeed a permeability of the cornea will cause the passage of elements present in the liquid flowing in the device through the cornea to the gel structure. An analysis of this gel thus makes it possible to detect and quantify this permeability.
Le trou 18 comprend un lamage 19, ce qui permet d'introduire et de fixer une vis afin de maintenir la stérilité de l'ensemble et de pouvoir accéder à la face interne de la cornée.The hole 18 comprises a countersink 19, which allows to introduce and fix a screw to maintain the sterility of the assembly and to access the inner face of the cornea.
La chambre de perfusion permet donc l'injection d'un gel pour rigidrfier la cornée et permet également le positionnement vertical de la cornée.The perfusion chamber therefore allows the injection of a gel to stiffen the cornea and also allows the vertical positioning of the cornea.
Il est également possible d'ajouter à la cornée des cellules conjonctivales afin d'avoir une œil "complet" cornée et conjonctive, de façon à améliorer la pertinence analyses de toxicité.It is also possible to add conjunctival cells to the cornea in order to have a "complete" corneal and conjunctive eye, so as to improve the relevance of toxicity analyzes.
Fig. 9 illustre un support de maintien 20 élaboré en polypropylène et servant à positionner la chambre de perfusion directement sur un biomicroscope afin d'étudier cliniquement la cornée.Fig. 9 illustrates a support support 20 made of polypropylene and used to position the perfusion chamber directly on a biomicroscope to study clinically the cornea.
Le support 20 est constitué d'une seule partie comportant un plateau inférieur formant socle et un plateau supérieur formant plateforme 23 destinée à accueillir la chambre de perfusion, réunies par une cloison verticale.The support 20 consists of a single part comprising a lower plate forming a base and an upper plateau forming platform 23 for receiving the perfusion chamber, joined by a vertical partition.
Le socle est muni de deux trous débouchants non taraudés 21 permettant d'introduire deux pions 22 pour maintenir le support sur le biomicroscope. La plate-forme 23 comprend deux bordures encadrant une partie centrale rainurée. L'une des bordures est équipée d'une vis 24 permettant le serrage et le maintien de l'invention.The base is provided with two unthreaded through holes 21 for introducing two pins 22 to hold the support on the biomicroscope. The platform 23 comprises two borders framing a grooved central portion. One of the borders is equipped with a screw 24 for clamping and maintaining the invention.
Il faut noter que la présence de la vitre 6 permet un accès à la cornée pour réaliser des observations et/ou des examens ophtalmologiques. La position verticale de la cornée revêt ici une grande importance et permet de placer une cornée vivante dans le dispositif rendu stérile en face d'un dispositif classique d'observation ophtalmologique, d'un microscope ou d'une lampe à fente.It should be noted that the presence of the window 6 allows access to the cornea for observation and / or ophthalmological examination. The vertical position of the cornea is of great importance here and makes it possible to place a living cornea in the sterile device in front of a conventional ophthalmological observation device, a microscope or a slit lamp.
Il est notamment possible d'évaluer le comportement de particules de cosmétiques et d'observer l'action d'agglomérats formés par des particules de cosmétiques. De tels agglomérats peuvent rayer la cornée.In particular, it is possible to evaluate the behavior of cosmetic particles and to observe the action of agglomerates formed by particles of cosmetics. Such agglomerates can scratch the cornea.
On notera que le dispositif permet également l'étude de lentilles de contact et en particulier leur résistance aux cosmétiques et aux agglomérats formés par ceux-ci. Note that the device also allows the study of contact lenses and in particular their resistance to cosmetics and agglomerates formed by them.

Claims

REVENDICATIONS
1. Chambre de perfusion pour une cornée comprenant une enceinte étanche (1 , 2, 3, 6) apte à recevoir une coméθ, caractérisée en ce qu'elle comprend des moyens (16, 18) aptes à maintenir la forme de la cornée lorsque l'enceinte est disposée de telle sorte que la surface interne de la cornée soit verticale.1. Infusion chamber for a cornea comprising a sealed chamber (1, 2, 3, 6) adapted to receive a coméθ, characterized in that it comprises means (16, 18) able to maintain the shape of the cornea when the enclosure is arranged such that the inner surface of the cornea is vertical.
2. Chambre de perfusion suivant la revendication 1 , caractérisée en ce qu'elle comprend des moyens d'injection d'un gel dans ia cornée.2. Perfusion chamber according to claim 1, characterized in that it comprises means for injecting a gel into the cornea.
3. Chambre de perfusion suivant la revendication 2. caractérisée en ce que les moyens d'injection comprennent un orifice d'injection (18).3. Infusion chamber according to claim 2. characterized in that the injection means comprises an injection port (18).
4. Chambre de perfusion suivant les revendications 1 à 3, caractérisée en ce qu'elle comprend des moyens d'injection de fluide (9) sur la cornée.4. Perfusion chamber according to claims 1 to 3, characterized in that it comprises fluid injection means (9) on the cornea.
5. Chambre de perfusion suivant la revendication 4, caractérisée en ce que le fluide a des propriétés irritantes.5. Perfusion chamber according to claim 4, characterized in that the fluid has irritating properties.
6. Chambre de perfusion suivant la revendication 4, caractérisée en ce que le fluide est un fluide lacrymal.Infusion chamber according to claim 4, characterized in that the fluid is a lacrimal fluid.
7. Chambre de perfusion suivant la revendication 4, caractérisée en ce que les moyens d'injection de fluide comprennent au moins un orifice (9).7. Perfusion chamber according to claim 4, characterized in that the fluid injection means comprise at least one orifice (9).
8. Chambre de perfusion suivant l'une quelconque des revendications 1 à 7, caractérisée en ce qu'elle comprend un support conique (16) permettant de faire reposer la cornée.8. Perfusion chamber according to any one of claims 1 to 7, characterized in that it comprises a conical support (16) for resting the cornea.
9. Chambre de perfusion suivant les revendications 4 et 7, caractérisée en ce qu elle comporte une paroi latérale cylindrique, l'orifice (9) étant disposé tangentiellement à la paroi latérale cylindrique.9. Perfusion chamber according to claims 4 and 7, characterized in that it comprises a cylindrical side wall, the orifice (9) being arranged tangentially to the cylindrical side wall.
10. Chambre de perfusion suivant l'une quelconque des revendications 1 à 9, caractérisée en ce qu'elle comprend une paroi transparente apte à permettre l'observation de la cornée. . Chambre de perfusion suivant l'une quelconque des revendications 1 à 10, caractérisée en ce qu'elle est mise en place sur un support de chambre de perfusion . Procède de préparation d'une cornée, caractérisé en ce que la cornée est disposée dans une chambre de perfusion suivant l'une quelconque des revendications 1 à 10, un gel étant injecté dans la cornée. . Procédé selon la revendication 12, caractérisé en ce que l'on ajoute à la cornée des cellules conjonctivales. 10. Perfusion chamber according to any one of claims 1 to 9, characterized in that it comprises a transparent wall adapted to allow observation of the cornea. . Infusion chamber according to any one of claims 1 to 10, characterized in that it is placed on an infusion chamber support. A process for preparing a cornea, characterized in that the cornea is disposed in an infusion chamber according to any one of claims 1 to 10, a gel being injected into the cornea. . Method according to claim 12, characterized in that conjunctival cells are added to the cornea.
PCT/IB2010/051521 2009-04-09 2010-04-08 Infusion chamber for a cornea WO2010116338A1 (en)

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FR0901758A FR2944185B1 (en) 2009-04-09 2009-04-09 INFUSION CHAMBER FOR CORNEA

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WO2019115754A1 (en) * 2017-12-15 2019-06-20 Universite Jean Monnet Medical device in the form of a cartridge for preservation of a corneal specimen
FR3074996A1 (en) * 2017-12-15 2019-06-21 Universite Jean Monnet MEDICAL DEVICE FOR PRESERVING AND / OR QUALITY CONTROL AND / OR TREATMENT OF CORNEAL SAMPLING INCLUDING AN APPLICATION COVER, AND IF NECESSARY A TREPANATION COVER
FR3074997A1 (en) * 2017-12-15 2019-06-21 Universite Jean Monnet CASSETTE MEDICAL DEVICE FOR PRESERVING AND / OR QUALITY CONTROL AND / OR TREATMENT OF CORNEAL SAMPLING
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US11229201B2 (en) 2017-12-15 2022-01-25 Universite Jean Monnet Medical device for preservation of a corneal tissue, comprising an applanation lid, and optionally a trepanation lid
CN111787796B (en) * 2017-12-15 2022-05-03 让·莫纳大学 Medical device in the form of a cartridge for preserving corneal specimens

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