EP1858448A2 - Cartridge for the injection of a flexible intraocular implant and device for packaging and installing one such implant in the cartridge - Google Patents

Cartridge for the injection of a flexible intraocular implant and device for packaging and installing one such implant in the cartridge

Info

Publication number
EP1858448A2
EP1858448A2 EP05802430A EP05802430A EP1858448A2 EP 1858448 A2 EP1858448 A2 EP 1858448A2 EP 05802430 A EP05802430 A EP 05802430A EP 05802430 A EP05802430 A EP 05802430A EP 1858448 A2 EP1858448 A2 EP 1858448A2
Authority
EP
European Patent Office
Prior art keywords
implant
cartridge
clipping
injection
thrust
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP05802430A
Other languages
German (de)
French (fr)
Inventor
Benoît MARI
Pierre Luc Naumi
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
New Millenium Medical Europe Sas
Original Assignee
New Millenium Medical Europe Sas
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by New Millenium Medical Europe Sas filed Critical New Millenium Medical Europe Sas
Publication of EP1858448A2 publication Critical patent/EP1858448A2/en
Withdrawn legal-status Critical Current

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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
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/14—Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
    • A61F2/16—Intraocular lenses
    • A61F2/1662—Instruments for inserting intraocular lenses into the eye
    • A61F2/1664—Instruments for inserting intraocular lenses into the eye for manual insertion during surgery, e.g. forceps-like instruments

Definitions

  • Cartridge for injecting a flexible intraocular implant and device for packaging and installing such an implant in this cartridge.
  • the present invention relates to a cartridge for injecting a flexible intraocular implant in the anterior chamber or posterior chamber of an eye, replacing a lens losing its transparency. It also relates to a device for packaging and installing an intraocular implant in this
  • the replacement of the natural lens by a flexible intra-ocular implant (called I. O. L. in specialized circles) is a very common surgical procedure practiced to give a good view to people with cataracts. For this, the surgeon must make a small incision in the cornea, extract the opacified original lens and introduce, in its place, an artificial lens having the desired characteristics whose optical qualities are defined by the ophthalmologist surgeon.
  • This instrumentation includes an injection cartridge for guiding the intraocular implant to its functional location in the eye.
  • an intraocular lens injection cartridge (WO-00/62712) comprising: a body having an asymmetrical bore which is rounded in cross-section on a first side and which is in ramp on another side; an injection nozzle formed integrally with the body, said nozzle having a bore which communicates with the asymmetrical bore of the body; and said bore tapering gently into an oval or a circle, in cross-section, near said base.
  • This cartridge makes it possible to inject symmetrical and asymmetrical intraocular implants, which is not the case of the so-called “butterfly” cartridges (by for example: US-5,499,987, US-5,735,858, US-6,129,733).
  • the cartridge described in WO-00/62712 nevertheless has two major drawbacks which are the obligation to use a clamp to position the flexible lens in the injection cartridge and the difficulty of removing the clamp when you have placed the implant at the entrance of the cartridge.
  • a folding device for folding an intraocular lens which has a resiliently deformable optic
  • said folding device comprising: a tubular member having a bore and at least one open end leading to said bore, said a bore being dimensioned and adapted to receive an intraocular lens adapted to be folded and to maintain the intraocular lens in a folded condition; said tubular member having a peripheral wall having an opening leading to said bore, said opening being sized and adapted to allow passage of an intraocular lens in the folded state through the opening and into the bore; and said tubular member having a generally opposed first slot and second slot opening at said open end of the tubular member and being sized to receive first and second arms, respectively, of a forceps, said first slot and said second generally opposed slot being arranged such that an intraocular lens in the folded state in said tubular member can be held between first and second arms of a forceps received in said first slot and in said second slot, usually opposite, respectively.
  • the invention proposes to make available to practitioners, on the one hand, a universal injection cartridge of intraocular implants (IOL), that is to say an injection cartridge compatible with all crystalline implants currently available on the market, and to solve the problems causing the previously described drawbacks, and, secondly, a dedicated device usable for the packaging and positioning of a crystalline implant, for example of the tripod type, in said injection cartridge, embodiments of an implant of this kind being, for example, described in the document SU-1.553.109 A1 or in the document FR-2.792.825.
  • IOL intraocular implants
  • the injection cartridge according to the invention comprises: a tubular reception chamber of oblong section open at the rear and delimited by a wall, part of which is arranged to constitute a receiving surface or area for an intraocular implant (IOL ) flexible introduced into said chamber and an injection cannula disposed in the extension thereof with which it communicates via a compaction chamber in the form of a funnel, this cartridge being particularly remarkable in that the wall delimiting the receiving chamber of the implant is provided with two longitudinal slots whose media are arranged in a plane passing through the middle of said reception range, these slots allowing the passage of the jaws of the pinching instrument used for the introduction of said implant into the cartridge.
  • IOL intraocular implant
  • the slot formed in the upper part of the wall delimiting the receiving chamber has a greater width than that of the slot in the lower part of said wall which constitutes the reception range of the implant.
  • the injection cartridge comprises, on the upper part of the wall delimiting the closed distal portion of the receiving chamber, a longitudinal guide groove disposed in the extension of the upper slot formed in the split proximal portion of said wall.
  • the advantage of the injection cartridge according to the invention is that it allows the implant to be easily clipped into the receiving chamber by means of a clamp known per se or by means of the dedicated device described. hereinafter, so that said implant is positioned stably and perfectly oriented at the entrance of the cartridge and, secondly, to allow the release of the clamp without risk of displacement or alteration of the implant.
  • the invention also relates to a dedicated device for packaging and installing a flexible lens implant in the claimed injection cartridge.
  • the packaging device for the installation of a crystalline implant, for example of the tripod type, in an injection cartridge according to the invention comprises a flexible tongue of clipping and a flexible pushing tab arranged vis-à-vis and whose distal ends can be spaced from each other and have concave surfaces facing each other, so as to constitute an oval shaped housing to allow the passage and retention of a diametral portion of the central lens of said implant, the clipping tongue preferably having a greater width than that of the thrust tongue, which is provided with a thrust pin disposed behind its concave surface, the tongue of clipping being housed in a longitudinal opening that has a flexible positioning plate whose distal end is provided with a recess, preferably circular formed in its inner face to receive the lateral parts of the implant
  • This device can be sterilized with a 1OL positioned in its distal portion, and thus serve as means of packaging, presentation and manipulation of the implant.
  • This device eliminates any direct manipulation of the implant after opening the packaging in which said device and the sterilized implant are kept waiting for use. In this way, all risks associated with possible poor grip or manipulation of the implant when it is inserted into the injection cartridge are discarded.
  • Figure 1 is a perspective view of an injection cartridge according to the invention.
  • Figure 2 is a plan view, on an enlarged scale, of this injection cartridge.
  • Figure 3 is a side view of Figure 2.
  • Figure 4 is a rear view, on a larger scale, of the injection cartridge.
  • FIG. 5 is a sectional view, on a larger scale, along the line 5-5 of FIG. 2.
  • FIG. 6 is a sectional view, on a larger scale, along the line 6-6 of FIG. 2.
  • Figure 7 is a sectional view along the line 7-7 of Figure 3.
  • FIG. 8 is a plan view of a tripod type crystalline implant that can be used for the implementation of the injection cartridge and the packaging device according to the invention.
  • Figure 9 is a bottom view of the packaging device according to the invention.
  • Figure 10 is a side view of Figure 9.
  • Figure 11 is a top view of Figure 9.
  • Figure 12 is a detail view, in perspective and downwardly, showing the distal ends of the positioning plate and the clipping tab.
  • Figure 13 is a detail view, in perspective and dive, of the distal ends of said plate and tongue.
  • Figure 14 is a detail view, in perspective and dive, showing the distal end of the push tab.
  • FIGS. 15A to 15E illustrate the steps of placing a tripod-type crystalline implant packaged in the device according to the invention in an injection cartridge.
  • Figs. 16A-16C are sectional views taken along lines 16A-16A, 16B-16B, 16C-16C, Figs. 15A, 15B, and 15C, respectively.
  • This cartridge may be formed in one piece, by molding, of any suitable thermoplastic material such as polypropylene or other.
  • the receiving chamber 2 has a symmetrical oblong section delimited by the lower receiving region 3a having a concave bearing surface and two symmetrical sides.
  • the compacting chamber 4 has, in its part connecting to the receiving chamber 2, an oblong section which decreases progressively in the direction of the injection cannula 5, to present, at the point of its connection to the here, a section almost circular or slightly oval.
  • the injection cannula 5 has a beveled distal end (FIG. 3).
  • the tubular wall 3 delimiting the reception chamber 2 of the injection cartridge is provided with two longitudinal slots 6 and 7, the media of which are arranged in a plane PP passing through the middle of the reception zone 3a. , in the direction of the length (figure 4). These slots open at the open proximal end or entrance of the cartridge.
  • the slot 6 formed in the upper part of the wall 3 delimiting the receiving chamber 2 has a width L plus important that the width I of the slot 7 formed in the lower part of said wall which constitutes the receiving range 3a of the implant ( Figure 4).
  • This width L is determined to allow the introduction of the flexible implant by a lateral pressure movement exerted on said implant perpendicular to the axis of the cartridge.
  • the upper slot 6 may have a width L of the order of 4.30 mm, while the lower slot may have a width of the order of 1, 20 mm.
  • the upper slot 6 preferably has a length less than the length of the lower slot 7.
  • the upper slot 6 may have a length of the order of 11.5 mm, while the lower slot 7 may have a length of length of 12.5 mm.
  • the universal injection cartridge according to the invention is compatible with all the currently available crystalline implants on the market, such as implants known as tripod, 3 pieces, shuttle, monobloc.
  • the invention also relates to a device for packaging and installing a crystalline implant, for example of the tripod type, in the universal injection cartridge described above.
  • This device can be used for the packaging and installation of crystalline implants in the injection cartridge 1 and is described below, by way of example, the application of this device to the packaging and installation of a tripod type implant, implant 16 of this kind having a central optical element or lens elements 16a and the haptic ⁇ " ⁇ dozens ⁇ roire ⁇ iques T6B in form of" anserétitf ⁇ ⁇ illustrated by way of example, in Figure 8.
  • the injection cartridge 1 comprises, on the upper part of the wall 3 delimiting the closed distal portion of the receiving chamber 2, a longitudinal guide groove 8 arranged in the extension of the upper slot 6 formed in the split proximal portion of said wall ( Figures 1 and 2) and, for example, delimited by two parallel ribs 9.
  • the packaging device 10 comprises two retaining tabs 11 and 12 which will be called, respectively, the clipping tab and the push tab, in the remainder of this description, in connection with one of their specific function. .
  • These tongues 11 and 12 are arranged one against the other and their distal ends 11a and 12a can be spaced from each other.
  • the surfaces disposed opposite these ends have a concave shape, so that when the tongues 11 and 12 are in the approaching position, said concave surfaces 11b, 12b delimit an oval or approximately oval shaped housing 13 allowing to contain, without significant play, a diametrical portion of the optics of an implant positioned between said ends.
  • the distal portion 11a of the clipping tab 11 has a larger width than that of the distal portion 12a of the thrust tongue 12, as can be seen in Figures 16A-16C.
  • the clipping tab 11 is housed in a longitudinal opening 14 that has a positioning plate 15 ( Figures 12 and 13).
  • the inner face of the distal end 15a of this plate is provided with a recess 15b, preferably of circular shape, whose bottom is provided with a diametrical slot 15d in which is engaged the distal end 12a of the pushing tongue 12.
  • This depression 15b is intended to receive the lateral portions and the haptic elements 16b of the implant 16 disposed on either side of its diametral portion placed in the housing 13.
  • the device may be implemented by molding, in any plastic r-igide-and-flexible-suitable ⁇ De la ⁇ so thanks to this Flexibility T-distale- -la-portion 15a of the positioning plate 15 may be spaced from the distal portion 11a of the clipping tab 11, while the distal portion 11a of said clipping tab 1 1 may be spaced from the distal portion of the thrust tongue 12.
  • the positioning plate 15 and the clipping tab 11 can be molded in one piece and made integral at their proximal end, while the thrust tongue 12 can be attached to the plate-15 assembly 11 by means of a tenon assembly or by gluing.
  • the distal ends of the tongues 11 and 12 are provided with a spout 11c, 12c, respectively, whose end surfaces are sloped and converge towards the housing 13.
  • the tongue 12 is provided with a thrust pin 12d (FIG. 14). Faced with this lug 12d, the clipping tab 11 is provided with a centering light 11d in which is engaged said thrust pin.
  • the distal end of the positioning plate 15 is provided with a support nose 15c extending in front of the distal ends of the tongues 11 and 12.
  • the tripod type crystalline implant 16 is hooked by means of one of its haptic elements 16b, around the "bridging" constituted by the noses 11c and 12c of the clipping and thrust tongues 12, respectively, the diametrical portion of its lens 16a is enclosed in the housing 13, and said lens sits against the thrust pin 12d, by a portion of its edge between its two other haptic elements 16b.
  • the projecting lateral portions of the implant are positioned in the circular recess 15b of the positioning plate 15, as can be seen in FIGS. 15A and 16A.
  • the implant thus very stably positioned, without load, and the conditioning device are sterilized and housed in a suitable sealed packaging (not shown) for the conservation of qualities ⁇ O ⁇ ptics and physical properties of the implant in the state " desirable, this package may contain, if necessary, an aqueous solution.
  • FIGS. 15A and 16A illustrate the first step of the process of positioning the implant 16 in an injection cartridge 1.
  • the spout 15c of the positioning plate 15 is placed in abutment on the bottom of the groove 8 of the cartridge, at the proximal end of said groove.
  • the implant 16 is pushed into the proximal portion of the receiving chamber 2 of the cartridge, under the pressing action exerted by the clipping tab 11.
  • a pushing movement of the device forwards makes it possible to bring the implant 16 into the closed distal part of the reception chamber 2, through via the thrust pin 12d of the tongue 12 (FIG. 16E). It is observed that the thrust pin 12d has a width greater than that of the lower slot 7, so as to remain inside the receiving chamber 2 during its translation towards the distal portion of said chamber.
  • the forward movement of the transfer device is limited by a stop, for example constituted by the pin 12d which abuts thrust limtre_le_fo_nd_de_la__fe.rjte_Z, _en_fin._de_course-de - displacement ⁇ -In-Gette- position, the implant 16 is positioned and pre-compacted in the distal portion of the receiving chamber 2 of the cartridge and the device can be released from the cartridge by a backward movement.
  • the practitioner can then proceed with the transfer of the crystalline implant into the patient's eye using a pushing instrument or injector known per se.
  • the invention also relates to packages consisting of a device 10 as described above, in which a crystalline implant 16 is positioned in the manner previously described, said device and I 1 IOL thus positioned being housed in the sterilized state in a hermetic package containing or not an aqueous solution for the conservation of the optical and physical qualities of the implant.
  • the invention also relates to a device for packaging and introducing a crystalline implant into the capsular bag of an eye, comprising, on the one hand, an injection cartridge as described above and, on the other hand, on the one hand, a conditioning device having the above-mentioned features, the upper and lower slots 6 formed in the proximal portion of the injection cartridge 1, and the distal portions 11a, 12a, clipping and thrust tabs 12, respectively , having widths such that the thrust tongue 12 can pass through the upper and lower slots 7 of the cartridge, while the clipping tab 11 can pass through said upper slot 6, but can not pass through said lower slot 7.

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  • Health & Medical Sciences (AREA)
  • Ophthalmology & Optometry (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Abstract

The invention relates to a flexible intraocular (IOL) implant injection cartridge. The inventive cartridge comprises: a tubular reception chamber (2) of oblong section, which is open at the rear and which is defined by a wall (3) having one part which is arranged to form a reception surface (3a) for a flexible intraocular implant that is introduced into the chamber; and an injection cannula (5) which extends from the chamber and which communicates with same by means of a cup-shaped compacting chamber (4). The invention is characterised in that the aforementioned wall (3) defining the proximal part of the reception chamber (2) is equipped with two longitudinal slits (6, 7), the midpoints of which are disposed in a plane (P-P) that cuts through the middle of the reception area or surface (3a).

Description

Cartouche pour l'injection d'un implant intraoculaire flexible, et dispositif de conditionnement et d'installation d'un tel implant dans cette cartouche.Cartridge for injecting a flexible intraocular implant, and device for packaging and installing such an implant in this cartridge.
La présente invention concerne une cartouche pour l'injection d'un implant intraoculaire flexible en chambre antérieure ou en chambre postérieure d'un œil, en remplacement d'un cristallin perdant sa transparence. Elle vise également un dispositif de conditionnement et d'installation d'un implant intraoculaire dans cetteThe present invention relates to a cartridge for injecting a flexible intraocular implant in the anterior chamber or posterior chamber of an eye, replacing a lens losing its transparency. It also relates to a device for packaging and installing an intraocular implant in this
-cartouche-dϋnjection.--cartouche-dϋnjection.-
Le remplacement du cristallin naturel par un Implant Intra-Oculaire souple (appelé I. O. L. dans les milieux spécialisés) est une intervention chirurgicale très courante pratiquée afin de rendre une bonne vue aux personnes atteintes de cataracte. Pour cela, le chirurgien doit pratiquer une incision de taille réduite dans la cornée, extraire le cristallin originel opacifié et introduire, à sa place, un cristallin artificiel présentant les caractéristiques désirées dont les qualités optiques sont définies par le chirurgien ophtalmologiste.The replacement of the natural lens by a flexible intra-ocular implant (called I. O. L. in specialized circles) is a very common surgical procedure practiced to give a good view to people with cataracts. For this, the surgeon must make a small incision in the cornea, extract the opacified original lens and introduce, in its place, an artificial lens having the desired characteristics whose optical qualities are defined by the ophthalmologist surgeon.
On connaît plusieurs types d'implants cristalliniens souples comprenant une optique transparente et qui sur le plan de l'aspect général diffèrent principalement par la forme de leurs haptiques.Several types of soft crystalline implants are known which comprise a transparent optic and which in terms of general appearance differ mainly in the shape of their haptics.
Différents instruments ont été proposés, en ophtalmologie, pour faciliter la mise en place de ces implants dans l'œil. Cette instrumentation comprend notamment une cartouche d'injection permettant de guider l'implant intra-oculaire jusqu'à son emplacement fonctionnel dans l'œil.Various instruments have been proposed, in ophthalmology, to facilitate the placement of these implants in the eye. This instrumentation includes an injection cartridge for guiding the intraocular implant to its functional location in the eye.
On connaît par exemple une cartouche d'injection de lentille intraoculaire (WO-00/62712) comportant : un corps ayant un alésage asymétrique qui est arrondi en coupe transversale sur un premier côté et qui est en rampe sur un autre côté ; une buse d'injection formée en un seul bloc avec le corps, cette buse ayant un alésage qui communique avec l'alésage asymétrique du corps ; et ledit alésage s'effilant de manière douce en un ovale ou en un cercle, en coupe transversale, à proximité de ladite base.For example, an intraocular lens injection cartridge (WO-00/62712) is known comprising: a body having an asymmetrical bore which is rounded in cross-section on a first side and which is in ramp on another side; an injection nozzle formed integrally with the body, said nozzle having a bore which communicates with the asymmetrical bore of the body; and said bore tapering gently into an oval or a circle, in cross-section, near said base.
Cette cartouche permet d'injecter des implants intraoculaires symétriques et asymétriques, ce qui n'est pas le cas des cartouches dites "papillon" (par exemple : US-5.499.987, US-5.735.858, US-6.129.733). Toutefois, la cartouche décrite dans le document WO-00/62712 présente néanmoins deux inconvénients importants qui sont l'obligation d'utiliser une pince pour positionner la lentille souple dans la cartouche d'injection et la difficulté de retirer cette pince lorsqu'on a placé l'implant à l'entrée de la cartouche.This cartridge makes it possible to inject symmetrical and asymmetrical intraocular implants, which is not the case of the so-called "butterfly" cartridges (by for example: US-5,499,987, US-5,735,858, US-6,129,733). However, the cartridge described in WO-00/62712 nevertheless has two major drawbacks which are the obligation to use a clamp to position the flexible lens in the injection cartridge and the difficulty of removing the clamp when you have placed the implant at the entrance of the cartridge.
Le premier de ces inconvénients résultant de l'obligation d'utiliser une pince pour-l'introduction-de-rimplant-dans-la-cartouche-d'injectionτ expose-celui-ci-à-des- risques, par exemple de rayure de l'optique lors de sa préhension, de pollution dudit implant ou de chute de ce dernier. De plus, la cartouche d'injection décrite dans le document WO-00/62712 ne résout pas les difficultés liées à la préhension et à l'orientation de l'implant sur la pince.The first of these disadvantages of the obligation to use pliers to the introduction-de rimplant-in-the-cartridge rubber injection-τ exposes it to des- risks, eg scratching the optics during its grip, pollution of said implant or fall of the latter. In addition, the injection cartridge described in WO-00/62712 does not solve the difficulties related to the gripping and orientation of the implant on the clamp.
Le second inconvénient souligné précédemment rend délicate la phase de retrait de la pince après avoir positionné l'implant dans la cartouche d'injection, le mouvement de retrait de la pince pouvant entraîner la chute de l'implant. On observe, en outre, que même une fois que l'on a retiré la pince, l'implant peut tomber, avec tous les risques que cela comporte. En effet, étant donné qu'il n'est que simplement déposé, en position prépliée, à l'entrée de la cartouche d'injection, il a tendance, du fait de son élasticité, à se dégager soudainement de ladite cartouche pour se déployer.The second disadvantage highlighted above makes delicate the withdrawal phase of the clamp after positioning the implant in the injection cartridge, the withdrawal movement of the clamp may cause the fall of the implant. It is further observed that even after removal of the forceps, the implant can fall, with all the risks that entails. Indeed, since it is only simply deposited, in pre-folded position, at the entrance of the injection cartridge, it tends, because of its elasticity, to suddenly disengage from said cartridge to deploy .
Dans le document WO-95/29648 est décrit un dispositif de pliage pour plier une lentille intraoculaire qui possède une optique déformable par résilience, ledit dispositif de pliage comprenant : un élément tubulaire possédant un alésage et au moins une extrémité ouverte menant audit alésage, ledit alésage étant dimensionné et étant conçu pour recevoir une lentille intraoculaire apte à être pliée et pour maintenir la lentille intraoculaire dans une condition à l'état plié ; ledit élément tubulaire possédant une paroi périphérique comportant une ouverture menant audit alésage, ladite ouverture étant dimensionnée et étant conçue pour permettre le passage d'une lentille intraoculaire à l'état plié à travers l'ouverture et à l'intérieur de l'alésage ; et ledit élément tubulaire possédant une première fente et une deuxième fente généralement opposées s'ouvrant à ladite extrémité ouverte de l'élément tubulaire et étant dimensionnées pour recevoir des premier et deuxième bras, respectivement, d'un forceps, ladite première fente et ladite deuxième fente généralement opposées étant disposées de telle sorte qu'une lentille intraoculaire à l'état plié dans ledit élément tubulaire peut être maintenue entre des premier et deuxième bras d'un forceps venant se loger dans ladite première fente et dans ladite deuxième fente, généralement opposées, respectivement.In WO-95/29648 there is disclosed a folding device for folding an intraocular lens which has a resiliently deformable optic, said folding device comprising: a tubular member having a bore and at least one open end leading to said bore, said a bore being dimensioned and adapted to receive an intraocular lens adapted to be folded and to maintain the intraocular lens in a folded condition; said tubular member having a peripheral wall having an opening leading to said bore, said opening being sized and adapted to allow passage of an intraocular lens in the folded state through the opening and into the bore; and said tubular member having a generally opposed first slot and second slot opening at said open end of the tubular member and being sized to receive first and second arms, respectively, of a forceps, said first slot and said second generally opposed slot being arranged such that an intraocular lens in the folded state in said tubular member can be held between first and second arms of a forceps received in said first slot and in said second slot, usually opposite, respectively.
Cet appareil improprement appelé "dispositif de pliage" a notamment pour -ineonvénients-^-This device improperly called "folding device" has particular -in-disadvantages - ^ -
Pobligation d'effectuer le pliage de la lentille intraoculaire avant son introduction dans l'élément tubulaire ;Requirement to fold the intraocular lens before insertion into the tubular element;
- l'obligation d'utiliser une pince pour transférer la lentille pliée de l'appareil de pliage proprement dit dans l'élément tubulaire, avec les risques précédemment soulignés de rayure de la lentille par les mâchoires de la pince, ou de chute et de pollution de cette dernière durant ce transfert ;- the obligation to use a clamp to transfer the folded lens of the folding device itself in the tubular element, with the previously underlined risk of scratching of the lens by the jaws of the clamp, or falling and of pollution of the latter during this transfer;
- ces manipulations nécessitant, par ailleurs, une grande habileté de la part des exécutants.- These manipulations require, moreover, a great skill on the part of the performers.
L'invention se propose de mettre à la disposition des praticiens, d'une part, une cartouche d'injection universelle d'implants intra-oculaire (I. O. L.), c'est-à-dire une cartouche d'injection compatible avec tous les implants cristalliniens actuellement disponibles sur le marché, et permettant de solutionner les problèmes engendrant les inconvénients précédemment exposés, et, d'autre part, un dispositif dédié utilisable pour le conditionnement et le positionnement d'un implant cristallinien, par exemple de type tripode, dans ladite cartouche d'injection, des modes d'exécution d'un implant de ce genre étant, par exemple, décrits dans le document SU-1.553.109 A1 ou dans le document FR-2.792.825.The invention proposes to make available to practitioners, on the one hand, a universal injection cartridge of intraocular implants (IOL), that is to say an injection cartridge compatible with all crystalline implants currently available on the market, and to solve the problems causing the previously described drawbacks, and, secondly, a dedicated device usable for the packaging and positioning of a crystalline implant, for example of the tripod type, in said injection cartridge, embodiments of an implant of this kind being, for example, described in the document SU-1.553.109 A1 or in the document FR-2.792.825.
La cartouche d'injection selon l'invention comprend : une chambre de réception tubulaire de section oblongue ouverte à l'arrière et délimitée par une paroi dont une partie est aménagée pour constituer une surface ou plage de réception pour un implant intra-oculaire (IOL) flexible introduit dans ladite chambre et une canule d'injection disposée dans le prolongement de celle-ci avec laquelle elle communique par l'intermédiaire d'une chambre de compactage en forme d'entonnoir, cette cartouche étant notamment remarquable en ce que la paroi délimitant la chambre de réception de l'implant est pourvue de deux fentes longitudinales dont les milieux sont disposés dans un plan passant par le milieu de ladite plage de réception, ces fentes permettant le passage des mâchoires de l'instrument de pincement utilisé pour l'introduction dudit implant dans la cartouche.The injection cartridge according to the invention comprises: a tubular reception chamber of oblong section open at the rear and delimited by a wall, part of which is arranged to constitute a receiving surface or area for an intraocular implant (IOL ) flexible introduced into said chamber and an injection cannula disposed in the extension thereof with which it communicates via a compaction chamber in the form of a funnel, this cartridge being particularly remarkable in that the wall delimiting the receiving chamber of the implant is provided with two longitudinal slots whose media are arranged in a plane passing through the middle of said reception range, these slots allowing the passage of the jaws of the pinching instrument used for the introduction of said implant into the cartridge.
Selon un mode d'exécution préféré, la fente ménagée dans la partie supérieure de la paroi délimitant la chambre de réception a une largeur plus importante que celle de la fente ménagée dans la partie inférieure de ladite paroi qui constitue la plage de réception de l'implant.According to a preferred embodiment, the slot formed in the upper part of the wall delimiting the receiving chamber has a greater width than that of the slot in the lower part of said wall which constitutes the reception range of the implant.
Selon un autre mode d'exécution avantageux, la cartouche d'injection comporte, sur la partie supérieure de la paroi délimitant la partie distale fermée de la chambre de réception, une gorge longitudinale de guidage disposée dans le prolongement de la fente supérieure ménagée dans la partie proximale fendue de ladite paroi.According to another advantageous embodiment, the injection cartridge comprises, on the upper part of the wall delimiting the closed distal portion of the receiving chamber, a longitudinal guide groove disposed in the extension of the upper slot formed in the split proximal portion of said wall.
La cartouche d'injection selon l'invention a pour avantages, d'une part, de permettre de clipser facilement l'implant dans la chambre de réception, au moyen d'une pince connue en soi ou à l'aide du dispositif dédié décrit ci-après, afin que ledit implant soit positionné de manière stable et parfaitement orienté à l'entrée de la cartouche et, d'autre part, de permettre le dégagement de la pince sans risque de déplacement ou d'altération de l'implant.The advantage of the injection cartridge according to the invention is that it allows the implant to be easily clipped into the receiving chamber by means of a clamp known per se or by means of the dedicated device described. hereinafter, so that said implant is positioned stably and perfectly oriented at the entrance of the cartridge and, secondly, to allow the release of the clamp without risk of displacement or alteration of the implant.
L'invention concerne également un dispositif dédié permettant le conditionnement et l'installation d'un implant cristallinien flexible dans la cartouche d'injection revendiquée.The invention also relates to a dedicated device for packaging and installing a flexible lens implant in the claimed injection cartridge.
Le dispositif de conditionnement pour l'installation d'un implant cristallinien, par exemple du type tripode, dans une cartouche d'injection selon l'invention, comprend une languette flexible de clipsage et une languette flexible de poussée disposées en vis-à-vis et dont les extrémités distales peuvent être écartées l'une de l'autre et présentent des surfaces concaves en regard, de sorte à constituer un logement de forme ovale pour permettre le passage et la retenue d'une portion diamétrale de la lentille centrale dudit implant, la languette de clipsage ayant, de préférence, une largeur plus importante que celle de la languette de poussée, laquelle est munie d'un ergot de poussée disposé en arrière de sa surface concave, la languette de clipsage étant logée dans une ouverture longitudinale que présente une plaquette de positionnement flexible dont l'extrémité distale est pourvue d'un enfoncement, de préférence circulaire ménagé dans sa face interne pour recevoir les parties latérales de l'implantThe packaging device for the installation of a crystalline implant, for example of the tripod type, in an injection cartridge according to the invention, comprises a flexible tongue of clipping and a flexible pushing tab arranged vis-à-vis and whose distal ends can be spaced from each other and have concave surfaces facing each other, so as to constitute an oval shaped housing to allow the passage and retention of a diametral portion of the central lens of said implant, the clipping tongue preferably having a greater width than that of the thrust tongue, which is provided with a thrust pin disposed behind its concave surface, the tongue of clipping being housed in a longitudinal opening that has a flexible positioning plate whose distal end is provided with a recess, preferably circular formed in its inner face to receive the lateral parts of the implant
"disposées de part et d'autre de sa portion diamétrale placée entre les extrémités distales concaves desdites languettes de clipsage et de poussée. "Disposed on either side of its diametral portion located between the concave distal ends of said clip and pusher tabs.
Un important avantage découlant de ce dispositif est qu'il peut être stérilisé avec un 1OL positionné dans sa partie distale, et servir ainsi de moyen de conditionnement, de présentation et de manipulation de l'implant. Ce dispositif supprime toute manipulation directe de l'implant après ouverture du conditionnement dans lequel ledit dispositif et l'implant stérilisés sont conservés en attente d'utilisation. On écarte de la sorte tous risques liés à une éventuelle mauvaise préhension ou manipulation de l'implant lors de son introduction dans la cartouche d'injection.An important advantage of this device is that it can be sterilized with a 1OL positioned in its distal portion, and thus serve as means of packaging, presentation and manipulation of the implant. This device eliminates any direct manipulation of the implant after opening the packaging in which said device and the sterilized implant are kept waiting for use. In this way, all risks associated with possible poor grip or manipulation of the implant when it is inserted into the injection cartridge are discarded.
Les buts, caractéristiques et avantages ci-dessus, et d'autres encore, ressortiront mieux de la description qui suit et des dessins annexés dans lesquels :The above and other objects, features and advantages will become more apparent from the following description and accompanying drawings, in which:
La figure 1 est une vue en perspective d'une cartouche d'injection selon l'invention.Figure 1 is a perspective view of an injection cartridge according to the invention.
La figure 2 est une vue en plan, à échelle agrandie, de cette cartouche d'injection.Figure 2 is a plan view, on an enlarged scale, of this injection cartridge.
La figure 3 est une vue de côté de la figure 2.Figure 3 is a side view of Figure 2.
La figure 4 est une vue arrière, à plus grande échelle, de la cartouche d'injection.Figure 4 is a rear view, on a larger scale, of the injection cartridge.
La figure 5 est une vue en coupe, à plus grande échelle, selon la ligne 5-5 de la figure 2. La figure 6 est une vue en coupe, à plus grande échelle, suivant la ligne 6- 6 de la figure 2.FIG. 5 is a sectional view, on a larger scale, along the line 5-5 of FIG. 2. FIG. 6 is a sectional view, on a larger scale, along the line 6-6 of FIG. 2.
La figure 7 est une vue en coupe selon la ligne 7-7 de la figure 3.Figure 7 is a sectional view along the line 7-7 of Figure 3.
La figure 8 est une vue en plan d'un implant cristallinien de type tripode utilisable pour la mise en œuvre de la cartouche d'injection et du dispositif de conditionnement selon l'invention.FIG. 8 is a plan view of a tripod type crystalline implant that can be used for the implementation of the injection cartridge and the packaging device according to the invention.
La figure 9 est une vue de dessous du dispositif de conditionnement selon l'invention.Figure 9 is a bottom view of the packaging device according to the invention.
La figure 10 est une vue de côté de la figure 9.Figure 10 is a side view of Figure 9.
La figure 11 est une vue de dessus de la figure 9.Figure 11 is a top view of Figure 9.
La figure 12 est une vue de détail, en perspective et en contre-plongée, montrant les extrémités distales de la plaquette de positionnement et de la languette de clipsage.Figure 12 is a detail view, in perspective and downwardly, showing the distal ends of the positioning plate and the clipping tab.
La figure 13 est une vue de détail, en perspective et en plongée, des extrémités distales desdites plaquette et languette.Figure 13 is a detail view, in perspective and dive, of the distal ends of said plate and tongue.
La figure 14 est une vue de détail, en perspective et en plongée, montrant l'extrémité distale de la languette de poussée.Figure 14 is a detail view, in perspective and dive, showing the distal end of the push tab.
Les figures 15A à 15E illustrent les étapes de la mise en place d'un implant cristallinien de type tripode conditionné dans le dispositif selon l'invention, dans une cartouche d'injection.FIGS. 15A to 15E illustrate the steps of placing a tripod-type crystalline implant packaged in the device according to the invention in an injection cartridge.
Les figures 16A à 16C sont des vues en coupe selon les lignes 16A-16A, 16B-16B, 16C-16C, des figures 15A, 15B et 15C, respectivement.Figs. 16A-16C are sectional views taken along lines 16A-16A, 16B-16B, 16C-16C, Figs. 15A, 15B, and 15C, respectively.
On se reporte auxdits dessins pour décrire des exemples de réalisation avantageux, bien que nullement limitatifs, de la cartouche d'injection et du dispositif de conditionnement et de positionnement, selon l'invention. Dans l'exposé qui suit, on utilise des termes tels que "supérieur", "inférieur", "avant", "arrière", "proximale", "distale", en considérant la position probable de manipulation de la cartouche d'injection lors de l'introduction de l'implant à l'arrière de celle-ci. Ces termes n'ont donc aucun caractère limitatif. D'autre part, l'expression "section oblongue" qualifie une section moins haute que large.Referring to said drawings to describe advantageous embodiments, although in no way limiting, of the injection cartridge and the packaging and positioning device according to the invention. In the following discussion, terms such as "superior", "inferior", "forward", "backward", "proximal", "distal" are used, considering the probable position of manipulation of the injection cartridge. when introducing the implant to the back of it. These terms are therefore not limiting in nature. On the other hand, the term "oblong section" qualifies a section less high than wide.
La-cartouGhe-d^injection-i-selon-IMnvention-est-du-genre-Gomprenant-une- chambre de réception tubulaire de section oblongue 2 ouverte à l'arrière et délimitée par une paroi 3 dont une partie 3a est aménagée pour constituer une plage de réception pour un implant intra-oculaire (IOL) flexible, cette chambre de réception se prolongeant vers l'amont, successivement par une chambre de compactage 4 en forme d'entonnoir et par une canule d'injection 5. Cette cartouche peut être formée d'une seule pièce, par moulage, en toute matière thermoplastique convenable telle que polypropylène ou autre.The-injection cartridge-i-according to the invention-is-the-kind-comprising-a tubular reception chamber of oblong section 2 open at the rear and delimited by a wall 3, a portion 3a is arranged to constituting a reception range for a flexible intraocular implant (IOL), this receiving chamber extending upstream, successively by a compaction chamber 4 in the form of a funnel and by an injection cannula 5. This cartridge may be formed in one piece, by molding, of any suitable thermoplastic material such as polypropylene or other.
La chambre de réception 2 présente une section oblongue symétrique délimitée par la plage de réception inférieure 3a présentant une surface d'appui concave et deux côtés symétriques. La chambre de compactage 4 présente, dans sa partie de raccordement à la chambre de réception 2, une section oblongue qui diminue progressivement en direction de la canule d'injection 5, jusqu'à présenter, à l'endroit de son raccordement à celle-ci, une section quasiment circulaire ou légèrement ovalisée. La canule d'injection 5 présente une extrémité distale biseautée (figure 3).The receiving chamber 2 has a symmetrical oblong section delimited by the lower receiving region 3a having a concave bearing surface and two symmetrical sides. The compacting chamber 4 has, in its part connecting to the receiving chamber 2, an oblong section which decreases progressively in the direction of the injection cannula 5, to present, at the point of its connection to the here, a section almost circular or slightly oval. The injection cannula 5 has a beveled distal end (FIG. 3).
Selon une première disposition caractéristique, la paroi tubulaire 3 délimitant la chambre de réception 2 de la cartouche d'injection est pourvue de deux fentes longitudinales 6 et 7 dont les milieux sont disposés dans un plan P-P passant par le milieu de la plage de réception 3a, dans le sens de la longueur (figure 4). Ces fentes débouchent à l'extrémité proximale ouverte ou entrée de la cartouche.According to a first characteristic arrangement, the tubular wall 3 delimiting the reception chamber 2 of the injection cartridge is provided with two longitudinal slots 6 and 7, the media of which are arranged in a plane PP passing through the middle of the reception zone 3a. , in the direction of the length (figure 4). These slots open at the open proximal end or entrance of the cartridge.
Selon un mode d'exécution avantageux, la fente 6 ménagée dans la partie supérieure de la paroi 3 délimitant la chambre de réception 2 a une largeur L plus importante que la largeur I de la fente 7 ménagée dans la partie inférieure de ladite paroi qui constitue la plage de réception 3a de l'implant (figure 4).According to an advantageous embodiment, the slot 6 formed in the upper part of the wall 3 delimiting the receiving chamber 2 has a width L plus important that the width I of the slot 7 formed in the lower part of said wall which constitutes the receiving range 3a of the implant (Figure 4).
Cette largeur L est déterminée pour permettre l'introduction de l'implant flexible par un mouvement de pression latérale exercé sur ledit implant perpendiculairement à l'axe de la cartouche.This width L is determined to allow the introduction of the flexible implant by a lateral pressure movement exerted on said implant perpendicular to the axis of the cartridge.
Par exemple, pour une cartouche d'injection présentant une longueur totale de 37 mm, la fente supérieure 6 peut avoir une largeur L de l'ordre de 4,30 mm, tandis que la fente inférieure peut avoir une largeur de l'ordre de 1 ,20 mm.For example, for an injection cartridge having a total length of 37 mm, the upper slot 6 may have a width L of the order of 4.30 mm, while the lower slot may have a width of the order of 1, 20 mm.
La fente supérieure 6 a, de préférence une longueur inférieure à la longueur de la fente inférieure 7. Par exemple, la fente supérieure 6 peut avoir une longueur de l'ordre de 11 ,5 mm, tandis que la fente inférieure 7 peut avoir une longueur de 12,5 mm.The upper slot 6 preferably has a length less than the length of the lower slot 7. For example, the upper slot 6 may have a length of the order of 11.5 mm, while the lower slot 7 may have a length of length of 12.5 mm.
On conçoit que lors de la mise en place d'un implant cristallinien dans la chambre de réception 2 de la cartouche d'injection 1 , l'extrémité distale de la pince qui tient ledit implant, est introduite dans ladite chambre à travers la fente supérieure 6, en engageant d'abord la mâchoire inférieure de ladite pince par un mouvement perpendiculaire à l'axe de la cartouche, de sorte que l'implant souple soit d'abord appliqué sur la surface supérieure de celle-ci, puis engagé et positionné sur la plage de réception 3a dans la partie proximale de la chambre de réception 2.It is conceivable that during the establishment of a crystalline implant in the receiving chamber 2 of the injection cartridge 1, the distal end of the clamp holding said implant is introduced into said chamber through the upper slot. 6, by first engaging the lower jaw of said clamp by a movement perpendicular to the axis of the cartridge, so that the flexible implant is first applied to the upper surface thereof, and then engaged and positioned on the reception zone 3a in the proximal part of the reception chamber 2.
Une fois l'implant introduit dans la chambre de réception, il est relâché, tend à reprendre son état initial et se trouve clipsé dans son logement. Les fentesOnce the implant is introduced into the receiving chamber, it is released, tends to return to its original state and is clipped into its housing. Slots
6 et 7 de la cartouche permettent alors de dégager facilement les mâchoires de la pince qui s'écartent radialement de ladite cartouche, sans aucun frottement sur l'optique de l'implant dont l'intégrité se trouve ainsi préservée.6 and 7 of the cartridge then make it easy to disengage the jaws of the clamp which deviate radially from said cartridge, without any friction on the optics of the implant whose integrity is thus preserved.
Comme indiqué précédemment, la cartouche d'injection universelle selon l'invention est compatible avec tous les implants cristalliniens actuellement disponibles sur le marché, tels que les implants connus sous les noms de tripode, 3 pièces, navette, monobloc. L'invention concerne également un dispositif de conditionnement et d'installation d'un implant cristallinien, par exemple de type tripode, dans la cartouche d'injection universelle précédemment décrite. Ce dispositif peut être utilisé pour le conditionnement et l'installation d'implants cristalliniens dans la cartouche d'injection 1 et on décrit ci-après, à titre d'exemple, l'application de ce dispositif au conditionnement et à l'installation d'un implant de type tripode, un implant 16 de ce genre comportant un élément d'optique central ou lentille 16a et des-éléments~d'haptique"t6b~péτrphéτiques en forme "d'anserétânf~illustré~a titre d'exemple, à la figure 8.As indicated above, the universal injection cartridge according to the invention is compatible with all the currently available crystalline implants on the market, such as implants known as tripod, 3 pieces, shuttle, monobloc. The invention also relates to a device for packaging and installing a crystalline implant, for example of the tripod type, in the universal injection cartridge described above. This device can be used for the packaging and installation of crystalline implants in the injection cartridge 1 and is described below, by way of example, the application of this device to the packaging and installation of a tripod type implant, implant 16 of this kind having a central optical element or lens elements 16a and the haptic ~ "~ péτrphéτiques T6B in form of" anserétânf ~ ~ illustrated by way of example, in Figure 8.
Dans ce cas, la cartouche d'injection 1 comporte, sur la partie supérieure de la paroi 3 délimitant la partie distale fermée de la chambre de réception 2, une gorge longitudinale de guidage 8 disposée dans le prolongement de la fente supérieure 6 ménagée dans la partie proximale fendue de ladite paroi (figures 1 et 2) et, par exemple, délimitée par deux nervures parallèles 9.In this case, the injection cartridge 1 comprises, on the upper part of the wall 3 delimiting the closed distal portion of the receiving chamber 2, a longitudinal guide groove 8 arranged in the extension of the upper slot 6 formed in the split proximal portion of said wall (Figures 1 and 2) and, for example, delimited by two parallel ribs 9.
Le dispositif de conditionnement 10 selon l'invention comprend deux languettes de retenue 11 et 12 que l'on appellera, respectivement, languette de clipsage et languette de poussée, dans la suite du présent exposé, en rapport avec l'une de leur fonction spécifique. Ces languettes 11 et 12 sont disposées l'une contre l'autre et leurs extrémités distales 11a et 12a peuvent être écartées l'une de l'autre. Les surfaces disposées en vis-à-vis de ces extrémités ont une forme concave, de sorte que lorsque les languettes 11 et 12 se trouvent en position de rapprochement, lesdites surfaces concaves 11b, 12b délimitent un logement de forme ovale ou approximativement ovale 13 permettant de contenir, sans jeu notable, une portion diamétrale de l'optique d'un implant positionné entre lesdites extrémités.The packaging device 10 according to the invention comprises two retaining tabs 11 and 12 which will be called, respectively, the clipping tab and the push tab, in the remainder of this description, in connection with one of their specific function. . These tongues 11 and 12 are arranged one against the other and their distal ends 11a and 12a can be spaced from each other. The surfaces disposed opposite these ends have a concave shape, so that when the tongues 11 and 12 are in the approaching position, said concave surfaces 11b, 12b delimit an oval or approximately oval shaped housing 13 allowing to contain, without significant play, a diametrical portion of the optics of an implant positioned between said ends.
De manière avantageuse, la partie distale 11a de la languette de clipsage 11 a une largeur plus importante que celle de la partie distale 12a de la languette de poussée 12, comme on peut le voir sur les figures 16A à 16C.Advantageously, the distal portion 11a of the clipping tab 11 has a larger width than that of the distal portion 12a of the thrust tongue 12, as can be seen in Figures 16A-16C.
La languette de clipsage 11 est logée dans une ouverture longitudinale 14 que présente une plaquette de positionnement 15 (figures 12 et 13). La face interne de l'extrémité distale 15a de cette plaquette est pourvue d'un enfoncement 15b, de préférence, de forme circulaire, dont le fond est doté d'une fente diamétrale 15d dans laquelle se trouve engagée l'extrémité distale 12a de la languette de poussée 12. Cet enfoncement 15b est destiné à recevoir les portions latérales et les éléments d'haptique 16b de l'implant 16 disposés de part et d'autre de sa portion diamétrale placée dans le logement 13.The clipping tab 11 is housed in a longitudinal opening 14 that has a positioning plate 15 (Figures 12 and 13). The inner face of the distal end 15a of this plate is provided with a recess 15b, preferably of circular shape, whose bottom is provided with a diametrical slot 15d in which is engaged the distal end 12a of the pushing tongue 12. This depression 15b is intended to receive the lateral portions and the haptic elements 16b of the implant 16 disposed on either side of its diametral portion placed in the housing 13.
Le dispositif peut être exécuté, par moulage, en toute matière plastique r-igide-et-flexible-convenable^De-la-sorte^grâce-à-cette-flexibilitéT-la-partie-distale- 15a de la plaquette de positionnement 15 peut être écartée de la partie distale 11a de la languette de clipsage 11 , tandis que la partie distale 11a de ladite languette de clipsage 1 1 peut être écartée de la partie distale de la languette de poussée 12.The device may be implemented by molding, in any plastic r-igide-and-flexible-suitable ^ De la ^ so thanks to this Flexibility T-distale- -la-portion 15a of the positioning plate 15 may be spaced from the distal portion 11a of the clipping tab 11, while the distal portion 11a of said clipping tab 1 1 may be spaced from the distal portion of the thrust tongue 12.
La plaquette de positionnement 15 et la languette de clipsage 11 peuvent être moulées d'une seule pièce et rendues solidaires au niveau de leur extrémité proximale, tandis que la languette de poussée 12 peut être fixée à l'ensemble plaquette 15-languette 11 au moyen d'un assemblage à tenons ou par collage.The positioning plate 15 and the clipping tab 11 can be molded in one piece and made integral at their proximal end, while the thrust tongue 12 can be attached to the plate-15 assembly 11 by means of a tenon assembly or by gluing.
Les extrémités distales des languettes 11 et 12 sont munies d'un bec 11c, 12c, respectivement, dont les surfaces d'extrémités sont pentées et convergent en direction du logement 13.The distal ends of the tongues 11 and 12 are provided with a spout 11c, 12c, respectively, whose end surfaces are sloped and converge towards the housing 13.
La languette 12 est munie d'un ergot de poussée 12d (figure 14). Face à cet ergot 12d, la languette de clipsage 11 est munie d'une lumière de centrage 11d dans laquelle est engagé ledit ergot de poussée.The tongue 12 is provided with a thrust pin 12d (FIG. 14). Faced with this lug 12d, the clipping tab 11 is provided with a centering light 11d in which is engaged said thrust pin.
L'extrémité distale de la plaquette de positionnement 15 est munie d'un bec d'appui 15c s'étendant devant les extrémités distales des languettes 11 et 12.The distal end of the positioning plate 15 is provided with a support nose 15c extending in front of the distal ends of the tongues 11 and 12.
On décrit ci-après le fonctionnement de ce dispositif de conditionnement et de positionnement selon l'invention.The operation of this conditioning and positioning device according to the invention is described below.
L'implant cristallinien de type tripode 16 est accroché par l'intermédiaire de l'un de ses éléments d'haptique 16b, autour du "pontage" constitué par les becs 11c et 12c des languettes de clipsage 11 et de poussée 12, respectivement, la partie diamétrale de sa lentille 16a est renfermée dans le logement 13, et ladite lentille se trouve en appui contre l'ergot de poussée 12d, par une portion de son bord comprise entre ses deux autres éléments d'haptique 16b. D'autre part, les parties latérales débordantes de l'implant sont positionnées dans l'enfoncement circulaire 15b de la plaquette de positionnement 15, comme on peut le voir sur les figures 15A et 16A. L'implant ainsi positionné de manière très stable, sans contrainte mécanique, et le dispositif de conditionnement, sont stérilisés et logés dans un emballage hermétique approprié (non représenté) permettant la conservation des qualites~~ô~ptiques et physiques de l'implant dans l'état" souhaitable, cet emballage pouvant contenir, si nécessaire, une solution aqueuse.The tripod type crystalline implant 16 is hooked by means of one of its haptic elements 16b, around the "bridging" constituted by the noses 11c and 12c of the clipping and thrust tongues 12, respectively, the diametrical portion of its lens 16a is enclosed in the housing 13, and said lens sits against the thrust pin 12d, by a portion of its edge between its two other haptic elements 16b. On the other hand, the projecting lateral portions of the implant are positioned in the circular recess 15b of the positioning plate 15, as can be seen in FIGS. 15A and 16A. The implant thus very stably positioned, without load, and the conditioning device are sterilized and housed in a suitable sealed packaging (not shown) for the conservation of qualities ~~ O ~ ptiques and physical properties of the implant in the state " desirable, this package may contain, if necessary, an aqueous solution.
Les figures 15A et 16A illustrent la première étape du processus de positionnement de l'implant 16 dans une cartouche d'injection 1. Le bec 15c de la plaquette de positionnement 15 est placé en appui sur le fond de la gorge 8 de la cartouche, à l'extrémité proximale de ladite gorge.FIGS. 15A and 16A illustrate the first step of the process of positioning the implant 16 in an injection cartridge 1. The spout 15c of the positioning plate 15 is placed in abutment on the bottom of the groove 8 of the cartridge, at the proximal end of said groove.
En exerçant un appui sur la partie proximale du dispositif, perpendiculairement à l'axe de celui-ci, on écarte le couple de languette 11-12 de la plaquette de positionnement 15, de sorte que l'implant 16 se trouve extrait de l'enfoncement 15b, la languette de poussée 12 se trouvant engagée dans les fentes 6 et 7 de la cartouche 1 (figures 15B, 16B).By pressing on the proximal part of the device, perpendicularly to the axis thereof, the tongue torque 11-12 is moved away from the positioning plate 15, so that the implant 16 is extracted from the depression 15b, the push tab 12 being engaged in the slots 6 and 7 of the cartridge 1 (Figures 15B, 16B).
En continuant d'appuyer sur la partie proximale du dispositif (figures 15C,Continuing to press on the proximal portion of the device (FIGS. 15C,
16C), on enfonce l'implant 16 dans la partie proximale de la chambre de réception 2 de la cartouche, sous l'action d'appui exercée par la languette de clipsage 11.16C), the implant 16 is pushed into the proximal portion of the receiving chamber 2 of the cartridge, under the pressing action exerted by the clipping tab 11.
La poursuite de ce mouvement d'appui a pour effet d'écarter les parties distales 11 a, 12b des languettes de clipsage 11 et de poussée 12, respectivement, de sorte que l'implant se trouve clipsé dans la partie proximale de la chambre de réception (figure 16D) et que les becs 11c, 12c s'écartent de l'élément d'haptique frontal précédemment retenu par le "pontage" formé par le rapprochement desdits becs.The continuation of this support movement has the effect of spreading the distal portions 11a, 12b clipping tongues 11 and push 12, respectively, so that the implant is clipped in the proximal portion of the chamber receiving (Figure 16D) and that the beaks 11c, 12c deviate from the front haptic element previously retained by the "bridging" formed by the approximation of said nozzles.
Un mouvement de poussée du dispositif vers l'avant permet d'amener l'implant 16 dans la partie distale fermée de la chambre de réception 2, par l'intermédiaire de l'ergot de poussée 12d de la languette 12 (figure 16E). On observe que l'ergot de poussée 12d a une largeur supérieure à celle de la fente inférieure 7, de sorte à rester à l'intérieur de la chambre de réception 2 durant sa translation en direction de la partie distale de ladite chambre.A pushing movement of the device forwards makes it possible to bring the implant 16 into the closed distal part of the reception chamber 2, through via the thrust pin 12d of the tongue 12 (FIG. 16E). It is observed that the thrust pin 12d has a width greater than that of the lower slot 7, so as to remain inside the receiving chamber 2 during its translation towards the distal portion of said chamber.
Le mouvement vers l'avant du dispositif de transfert est limité par une butée, par exemple constituée par l'ergot de poussée 12d lequel vient en appui çontre_le_fo_nd_de_la__fe.rjte_Z,_en_fin._de_course-de--déplacementτ-Dans-Gette- situation, l'implant 16 se trouve positionné et pré-compacté dans la partie distale de la chambre de réception 2 de la cartouche et le dispositif peut être dégagé de la cartouche par un mouvement de recul.The forward movement of the transfer device is limited by a stop, for example constituted by the pin 12d which abuts thrust çontre_le_fo_nd_de_la__fe.rjte_Z, _en_fin._de_course-de - displacement τ -In-Gette- position, the implant 16 is positioned and pre-compacted in the distal portion of the receiving chamber 2 of the cartridge and the device can be released from the cartridge by a backward movement.
Le praticien peut alors procéder au transfert de l'implant cristallinien, dans l'œil du patient, à l'aide d'un instrument de poussée ou injecteur connu en soi.The practitioner can then proceed with the transfer of the crystalline implant into the patient's eye using a pushing instrument or injector known per se.
L'invention concerne également les conditionnements constitués d'un dispositif 10 tel que décrit ci-dessus, dans lequel est positionné un implant cristallinien 16 de la manière précédemment décrite, ledit dispositif et I1IOL ainsi positionné étant logés à l'état stérilisé dans un emballage hermétique contenant ou non une solution aqueuse pour la conservation des qualités optiques et physiques de l'implant.The invention also relates to packages consisting of a device 10 as described above, in which a crystalline implant 16 is positioned in the manner previously described, said device and I 1 IOL thus positioned being housed in the sterilized state in a hermetic package containing or not an aqueous solution for the conservation of the optical and physical qualities of the implant.
L'invention concerne également un dispositif de conditionnement et d'introduction d'un implant cristallinien dans le sac capsulaire d'un œil, comprenant, d'une part, une cartouche d'injection telle que décrite ci-dessus et, d'autre part, un dispositif de conditionnement comportant les caractéristiques susmentionnées, les fentes supérieure 6 et inférieure 7 ménagées dans la partie proximale de la cartouche d'injection 1 , et les parties distales 11a, 12a, des languettes de clipsage 11 et de poussée 12, respectivement, ayant des largeurs telles que la languette de poussée 12 peut traverser les fentes supérieure 6 et inférieure 7 de la cartouche, alors que la languette de clipsage 11 peut traverser ladite fente supérieure 6, mais ne peut passer à travers ladite fente inférieure 7. The invention also relates to a device for packaging and introducing a crystalline implant into the capsular bag of an eye, comprising, on the one hand, an injection cartridge as described above and, on the other hand, on the one hand, a conditioning device having the above-mentioned features, the upper and lower slots 6 formed in the proximal portion of the injection cartridge 1, and the distal portions 11a, 12a, clipping and thrust tabs 12, respectively , having widths such that the thrust tongue 12 can pass through the upper and lower slots 7 of the cartridge, while the clipping tab 11 can pass through said upper slot 6, but can not pass through said lower slot 7.

Claims

REVENDICATIONS
1. Cartouche d'injection d'implant intra-oculaire (IOL) flexible comprenant une chambre de réception tubulaire (2) de section oblongue ouverte à l'arrière et délimitée par une paroi (3) dont une partie est aménagée pour constituer une surface de réception (3a) pour un implant intra-oculaire flexible introduit dans ladite chambre et une canule d'injection (5) disposée dans le prolongement de-celle^ci-avec-laquelle-elle-communique-par-l-intermédiaire-d^ne-ehambre- de compactage (4) en forme d'entonnoir, caractérisée en ce que la paroi (3) délimitant la partie proximale de la chambre de réception (2) est pourvue de deux fentes longitudinales (6,7) dont les milieux sont disposés dans un plan1. Flexible intraocular implant injection (IOL) cartridge comprising a tubular reception chamber (2) of oblong section open at the rear and delimited by a wall (3), part of which is arranged to constitute a surface receiving (3a) for a flexible intraocular implant introduced into said chamber and an injection cannula (5) arranged in the extension of the one-^ above-with which it communicates-by--l-intermediate-d Funnel-shaped compacting chamber (4), characterized in that the wall (3) delimiting the proximal portion of the receiving chamber (2) is provided with two longitudinal slots (6, 7) whose backgrounds are arranged in a plane
(P-P) passant par le milieu de ladite surface ou plage de réception (3a).(P-P) passing through the middle of said receiving surface or area (3a).
2. Cartouche d'injection selon la revendication 1, caractérisée en ce que la fente (6) ménagée dans la partie supérieure de la paroi (3) délimitant la chambre de réception (2) a une largeur (L) plus importante que celle de la fente (7) ménagée dans la partie inférieure de ladite paroi qui constitue la plage de réception (3a) de l'implant.2. Injection cartridge according to claim 1, characterized in that the slot (6) in the upper part of the wall (3) defining the receiving chamber (2) has a width (L) greater than that of the slot (7) formed in the lower part of said wall which constitutes the reception range (3a) of the implant.
3. Cartouche d'injection selon l'une des revendications 1 ou 2, caractérisée en ce que la fente (7) ménagée dans la partie inférieure (3a) de la paroi (3) délimitant la chambre de réception (2) a une longueur plus importante que celle de la fente (6) ménagée dans la partie supérieure de ladite paroi.3. Injection cartridge according to one of claims 1 or 2, characterized in that the slot (7) in the lower part (3a) of the wall (3) defining the receiving chamber (2) has a length greater than that of the slot (6) formed in the upper part of said wall.
4. Cartouche d'injection selon l'une quelconque des revendications 1 à 3, caractérisée en ce que les fentes (6, 7) débouchent à l'extrémité arrière ouverte de ladite cartouche.4. Injection cartridge according to any one of claims 1 to 3, characterized in that the slots (6, 7) open at the open rear end of said cartridge.
5. Cartouche d'injection selon l'une quelconque des revendications 1 à 4, caractérisée en ce que la fente supérieure (6) a une largeur (L) déterminée pour permettre l'introduction d'un implant cristallinien flexible par un mouvement de pression exercé perpendiculairement à l'axe de la cartouche.5. Injection cartridge according to any one of claims 1 to 4, characterized in that the upper slot (6) has a width (L) determined to allow the introduction of a flexible lens implant by a pressure movement perpendicular to the axis of the cartridge.
6. Cartouche d'injection suivant l'une quelconque des revendications 1 à 5, caractérisée en ce qu'elle comporte, sur la partie supérieure de la paroi (3) délimitant la partie distale fermée de la chambre de réception (2), une gorge longitudinale de guidage (8) disposée dans le prolongement de la fente supérieure (6) ménagée dans la partie proximale fendue de ladite paroi. .6. Injection cartridge according to any one of claims 1 to 5, characterized in that it comprises, on the upper part of the wall (3) delimiting the closed distal portion of the receiving chamber (2), a throat longitudinal guide (8) disposed in the extension of the upper slot (6) formed in the split proximal portion of said wall. .
7. Dispositif pour le conditionnement et le transfert d'un implant cristallinien dans une cartouche d'injection selon l'une quelconque des revendications 1 à 6, caractérisé en ce qu'il comprend une languette flexible de cϋpsage (1 1) et une languette flexible de poussée (12) disposées en vis-à-vis et dont les _extr_éjΩ]tés_dlstales__(J--la,_1-2a)_peuvent-être-écartées- -l'une- -de - ^autre- et- présentent des surfaces concaves en regard (11b, 12b), de sorte à constituer un logement de forme ovale (13) pour permettre le passage et la retenue d'une portion diamétrale de la lentille centrale (16a) d'un implant cristallinien7. A device for packaging and transferring a lens implant into an injection cartridge according to any one of claims 1 to 6, characterized in that it comprises a flexible tongue (1 1) and a tongue the thrust hose (12) arranged opposite each other and whose longitudinal extrusions (J-1a, 1-2a) may be spaced apart from one another; and Concave concave surfaces (11b, 12b) so as to constitute an oval-shaped housing (13) to allow passage and retention of a diametral portion of the central lens (16a) of a crystalline implant
(16) et la languette de clipsage (1 1) étant logée dans une ouverture longitudinale (15d) que présente une plaquette de positionnement flexible (15) dont l'extrémité distale (15a) est pourvue d'un enfoncement (15d), de préférence circulaire, ménagé dans sa face interne, pour recevoir les parties latérales de l'implant cristallinien (16) disposées de part et d'autre de sa portion diamétrale placée entre les extrémités distales concaves (1 1 b, 12b) desdites languettes de clipsage (1 1) et de poussée (12).(16) and the clipping tab (1 1) being housed in a longitudinal opening (15d) which has a flexible positioning plate (15) whose distal end (15a) is provided with a recess (15d), preferably circular, formed in its inner face, for receiving the lateral portions of the crystalline implant (16) disposed on either side of its diametral portion placed between the concave distal ends (1 1b, 12b) of said clipping tongues (1 1) and thrust (12).
8. Dispositif selon la revendication 7, caractérisé en ce que la partie distale de la languette de clipsage (11) a une largeur plus importante que celle de la languette de poussée (12).8. Device according to claim 7, characterized in that the distal portion of the clipping tab (11) has a greater width than that of the push tab (12).
9. Dispositif suivant l'une des revendications 7 ou 8, caractérisé en ce que les extrémités distales (11a, 12a) des languettes de clipsage (11) et de poussée (12) sont munies d'un bec (1 1 c, 12c) orientés l'un vers l'autre et dont les surfaces d'extrémité sont pentées et convergent en direction du logement (13) délimité par leurs surfaces concaves (11 b, 12b).9. Device according to one of claims 7 or 8, characterized in that the distal ends (11a, 12a) of the clipping tongues (11) and push (12) are provided with a spout (1 1c, 12c ) oriented toward one another and whose end surfaces are sloped and converge towards the housing (13) defined by their concave surfaces (11b, 12b).
10. Dispositif selon l'une quelconque des revendications 7 à 9, caractérisé en ce que l'extrémité distale de la plaquette de positionnement (15) est munie d'un bec (15c) s'étendant devant les extrémités distales des languettes de clipsage (1 1 ) et de poussée (12).10. Device according to any one of claims 7 to 9, characterized in that the distal end of the positioning plate (15) is provided with a spout (15c) extending in front of the distal ends of the clipping tongues. (1 1) and thrust (12).
11. Dispositif selon l'une quelconque des revendications 7 à 10, caractérisé en ce que la languette de poussée (12) est munie d'un ergot de poussée (12d) disposé en arrière de sa surface concave (12b) et orienté en direction de la languette de clipsage (11).11. Device according to any one of claims 7 to 10, characterized in that the thrust tongue (12) is provided with a thrust pin (12d). disposed behind its concave surface (12b) and oriented towards the clipping tab (11).
12. Dispositif suivant la revendication 11 , caractérisé en ce que la languette de clipsage est pourvue d'une lumière de centrage (11d) disposée face à l'ergot de poussée (12d) et dimensionnée pour recevoir l'extrémité libre de ce dernier.12. Device according to claim 11, characterized in that the clipping tab is provided with a centering light (11d) disposed opposite the thrust pin (12d) and dimensioned to receive the free end thereof.
13. Dispositif de conditionnement d'un implant cristallinien permettant le transfert de celui-ci dans une cartouche d'injection, selon l'une quelconque des revendications 7 à 12, caractérisé en ce qu'il comprend un implant cristallinien (16) du type comportant un élément optique central ou lentille13. Device for packaging a crystalline implant for transferring it into an injection cartridge, according to any one of claims 7 to 12, characterized in that it comprises a crystalline implant (16) of the type having a central optical element or lens
(16a) et des éléments périphériques d'haptiques (16b) en forme d'anses, cet implant cristallinien étant :(16a) and haptic peripheral elements (16b) in the shape of loops, this crystalline implant being:
positionné dans le logement (13) délimité par les extrémités distales (11a, 12a) des languettes de clipsage (11) et de poussée (12),positioned in the housing (13) delimited by the distal ends (11a, 12a) of the clipping tongues (11) and pushing tongues (12),
- accroché, par l'intermédiaire de l'un de ses éléments d'haptique (16b) autour du "pontage" constitué par le rapprochement des becs (11c, 12c) des languettes de clipsage (11) et de poussée (12) ;- Hooked, via one of its haptic elements (16b) around the "bridging" formed by the approach of the beaks (11c, 12c) clipping tongues (11) and thrust (12);
- disposé en appui, par l'intermédiaire d'une portion du bord dudit élément optique central (16a), et,- disposed in support, via a portion of the edge of said central optical element (16a), and
ses parties latérales étant logées dans l'enfoncement (15d) de la plaquette de poussée, l'IOL ainsi positionné et le dispositif de conditionnement étant logé dans un emballage hermétique assurant la préservation des qualités optiques et physiques de l'implant ainsi conditionné, cet emballage pouvant contenir une solution acqueuse contribuant à cette protection.its lateral parts being accommodated in the depression (15d) of the thrust plate, the IOL thus positioned and the conditioning device being housed in a hermetic packaging ensuring the preservation of the optical and physical qualities of the implant thus conditioned, this packaging that may contain an aqueous solution contributing to this protection.
14. Dispositif de conditionnement et d'introduction d'un implant cristallinien dans le sac capsulaire d'un œil, caractérisé en ce qu'il comprend, d'une part, une cartouche d'injection selon l'une quelconque des revendications 1 à 6 et, d'autre part, un dispositif de conditionnement selon l'une quelconque des revendications 7 à 13, les fentes supérieure (6) et inférieure (7) ménagées dans la partie proximale de la cartouche, et les parties distales (11a, 12a) des languettes de clipsage (11) et de poussée (12) ont des largeurs telles que la languette de poussée (12) peut traverser les fentes supérieure (6) et inférieure (7) de la cartouche, tandis que la languette de clipsage (12) peut traverser ladite fente supérieure, mais ne peut passer à travers ladite fente inférieure (7). 14. Apparatus for packaging and introducing a crystalline implant into the capsular bag of an eye, characterized in that it comprises, on the one hand, an injection cartridge according to any one of claims 1 to 6 and, on the other hand, a packaging device according to any one of claims 7 to 13, the upper (6) and lower (7) slots provided in the proximal portion of the cartridge, and the distal portions (11a, 12a) of the clipping (11) and pushing tabs (12) have widths such that the thrust tongue (12) can pass through the upper slots (6). and lower (7) of the cartridge, while the clipping tab (12) can pass through said upper slot, but can not pass through said lower slot (7).
EP05802430A 2004-09-16 2005-09-15 Cartridge for the injection of a flexible intraocular implant and device for packaging and installing one such implant in the cartridge Withdrawn EP1858448A2 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
FR0409852A FR2875126A1 (en) 2004-09-16 2004-09-16 CARTRIDGE FOR THE INJECTION OF A FLEXIBLE INTRAOCULAR IMPLANT, AND DEVICE FOR PACKAGING AND INSTALLING SUCH AN IMPLANT IN THIS CARTRIDGE
PCT/FR2005/002289 WO2006032763A2 (en) 2004-09-16 2005-09-15 Cartridge for the injection of a flexible intraocular implant and device for packaging and installing one such implant in the cartridge

Publications (1)

Publication Number Publication Date
EP1858448A2 true EP1858448A2 (en) 2007-11-28

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EP05802430A Withdrawn EP1858448A2 (en) 2004-09-16 2005-09-15 Cartridge for the injection of a flexible intraocular implant and device for packaging and installing one such implant in the cartridge

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EP (1) EP1858448A2 (en)
FR (1) FR2875126A1 (en)
WO (1) WO2006032763A2 (en)

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US8435289B2 (en) 2005-02-11 2013-05-07 Abbott Medical Optics Inc. Rapid exchange IOL insertion apparatus and methods of using
US9339374B2 (en) 2005-02-11 2016-05-17 Abbot Medical Optics Inc. Intraocular lens insertion apparatus and lens case
US8562674B2 (en) 2005-02-11 2013-10-22 Abbott Medical Optics Inc. Front loading IOL insertion apparatus and method of using
US7879090B2 (en) 2006-12-13 2011-02-01 Bausch & Lomb Incorporated Intraocular lens injector apparatus and methods of use
US10307292B2 (en) 2011-07-18 2019-06-04 Mor Research Applications Ltd Device for adjusting the intraocular pressure

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Publication number Priority date Publication date Assignee Title
US5653715A (en) * 1993-03-09 1997-08-05 Chiron Vision Corporation Apparatus for preparing an intraocular lens for insertion
WO1995013766A1 (en) * 1993-11-18 1995-05-26 Allergan, Inc. Deformable lens insertion apparatus
US5702402A (en) * 1994-04-29 1997-12-30 Allergal Method and apparatus for folding of intraocular lens

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Title
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WO2006032763A3 (en) 2006-08-10
WO2006032763A2 (en) 2006-03-30

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