FR2875126A1 - CARTRIDGE FOR THE INJECTION OF A FLEXIBLE INTRAOCULAR IMPLANT, AND DEVICE FOR PACKAGING AND INSTALLING SUCH AN IMPLANT IN THIS CARTRIDGE - Google Patents

Abstract

Flexible intraocular implant (IOL) injection cartridge comprising a tubular receiving chamber (2) of oblong section open at the rear and delimited by a wall (3), part of which is arranged to constitute a receiving surface (3a) for a flexible intraocular implant introduced into said chamber and an injection cannula (5) arranged in the extension thereof with which it communicates via a compacting chamber (4) in the form funnel, characterized in that the wall (3) delimiting the proximal part of the receiving chamber (2) is provided with two longitudinal slots (6,7) whose midpoints are arranged in a plane (PP) passing through the middle of said receiving surface or pad (3a).

Description

Cartridge for injection of 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 crystalline lens losing its transparency. It also relates to a device for packaging and installing an intraocular implant in this injection cartridge.

  The replacement of the natural lens with 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.

  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.

  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.

  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.

  This cartridge makes it possible to inject symmetrical and asymmetrical intraocular implants, which is not the case with "butterfly" cartridges (for example: US Pat. No. 5,499,987, US Pat. No. 5,735,858, US Pat. No. 6,229,733). 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.

  The first of these disadvantages resulting from the obligation to use a clamp for the introduction of the implant into the injection cartridge exposes it to risks, for example scratching the optics when gripping it. , 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.

  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 .

  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.

  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 range for an intraocular implant (IOL). flexible tube introduced into said chamber and an injection cannula disposed in the extension thereof with which it communicates via a funnel-shaped compaction chamber, this cartridge being particularly remarkable in that the wall defining 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 said implant in the cartridge.

  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.

  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.

  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 conditioning 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 clipping tongue and a flexible pushing tongue arranged in a screw-in position. screw and whose distal ends can be spaced from each other and have concave surfaces opposite, so as to form an oval shaped housing to allow the passage and retention of a diametral portion of the central lens of said implant, the clipping tab preferably having a greater width than that of the thrust tongue, which is provided with a thrust pin disposed behind its concave surface, the clipping tongue 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 for rec to have the lateral parts of the implant disposed on either side of its diametral portion placed between the concave distal ends of said tongues clipping and pushing.

  An important advantage of this device is that it can be sterilized with an IOL positioned in its distal portion, and thus serve as a 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.

  The above and other objects, features and advantages will become more apparent from the following description and accompanying drawings, in which: FIG. 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 55 of FIG. 2.

  Figure 6 is a sectional view, on a larger scale, taken along the line 6-6 of Figure 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.

  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.

  The injection cartridge 1 according to the invention is of the type comprising a tubular receiving chamber of oblong section 2 open at the rear and delimited by a wall 3, a portion 3a of which is arranged to constitute a reception range for an intra-implant. -ocular (IOL) flexible, this receiving chamber extending upstream, successively by a compaction chamber 4 funnel-shaped and by an injection cannula 5. This cartridge can 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 latter, a section almost circular or slightly oval. The injection cannula 5 has a beveled distal end (FIG. 3).

  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.

  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 greater than the width I of the slot 7 formed in the lower part of said wall which constitutes the reception range 3a of the implant (FIG. 4).

  This width L is determined to allow the introduction of the flexible implant by a lateral pressure movement exerted perpendicularly to the axis of the cartridge.

  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.

  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.

  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.

  Once the implant is introduced into the receiving chamber, it is released, tends to return to its original state and is clipped into its housing. The slots 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.

  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 a tripod type implant, an implant 16 of this kind comprising a central optical element or lens 16a and haptic peripheral elements 16 in the form of a loop, being illustrated by way of example, in FIG.

  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.

  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 1a and 12a can be spaced from each other. The surfaces arranged opposite these ends have a concave shape, so that when the tongues 11 and 12 are in the approach position, said concave surfaces 11b, 12b delimit an oval or approximately oval-shaped housing 13 to contain, without significant play, a diametrical portion of the optics of an implant positioned between said ends.

  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.

  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 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 can be executed, by molding, in any suitable rigid and flexible plastic material. In this way, thanks to this flexibility, the distal 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 11 may be away from the distal portion of the push tab 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 lip 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 operation of this conditioning and positioning device according to the invention is described below.

  The crystalline lens of the tripod type 16 is hooked by means of one of its haptic elements 16b, around the "bridging" constituted by the slats 11c and 12c of the clipping tongues 11 and pushing tongues 12, respectively , the diametrical portion of its lens 16a is enclosed in the housing 13, and said lens is in abutment 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 positioned in a very stable manner, without mechanical stress, and the packaging device, are sterilized and housed in a suitable hermetic packaging (not shown) allowing the conservation of the optical and physical qualities of the implant in the desired state. 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.

  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).

  Continuing to press on the proximal part of the device (FIGS. 15C, 16C), the implant 16 is pushed into the proximal part of the receiving chamber 2 of the cartridge, under the pressing action exerted by the tongue of clipping 11.

  The continuation of this support movement has the effect of spreading the distal portions 11a, 12b clipping tabs 11 and push 12, respectively, so that the implant is clipped in the proximal portion of the receiving chamber (Figure 16D) and the beaks 11c, 12c deviate from the front haptic element previously retained by the "bridging" formed by the approximation of said nozzles.

  A pushing movement of the device towards the front makes it possible to bring the implant 16 into the closed distal part of the reception chamber 2, by means of 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 thrust pin 12 which bears against the bottom of the slot 7, at the end of travel stroke. In this situation, the implant 16 is positioned and pre-compacted in the distal portion of the cartridge receiving chamber 2 and the device can be disengaged from the cartridge by a recoil motion.

  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 is positioned a crystalline implant 16 in the manner previously described, said device and the 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.

Claims (14)

-13-CLAIMS   1. 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 device (3a) for a flexible intraocular implant introduced into said chamber and an injection cannula (5) arranged in the extension thereof with which it communicates via a compacting chamber (4) funnel-shaped, characterized in that the wall (3) delimiting the proximal portion of the receiving chamber (2) is provided with two longitudinal slots (6, 7) whose media are arranged in a passing plane (PP) by the middle of said receiving surface or area (3a).   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. 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. 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. 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. Injection cartridge according to any one of claims 1 to 5, characterized in that it comprises, on the upper part of the wall (3) 30 delimiting the closed distal portion of the receiving chamber (2), a longitudinal guide groove (8) disposed in the extension of the upper slot (6) formed in the split proximal portion of said wall.   7. 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 clip tongue (11) and a flexible tongue with the distal ends (11a, 12a) spaced apart from one another and having concave surfaces facing each other (11b, 12b) so as to forming an oval-shaped housing (13) to allow the passage and retention of a diametral portion of the central lens (16a) of a lens implant (16) and the clipping tab (11) being housed in a longitudinal opening (15d) 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 parts of the implant lens (16) arranged on the other than its diametral portion placed between the concave distal ends (11b, 12b) of said clipping tongues (11) and pushing tongues (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 thrust tongue (12).   9. Device according to one of claims 7 or 8, characterized in that the distal ends (11a, 12a) of the clipping tongues (11) and pushing (12) are provided with a spout (11c, 12c) oriented to one another and whose end surfaces are sloped and converge towards the housing (13) defined by their concave surfaces (11b, 12b).   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. (11) and thrust (12).   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 in the direction the clipping tab (11).   12. Device according to claim 11, characterized in that the clipping tab is provided with a centering slot (11d) disposed opposite the thrust pin (12d) and dimensioned to receive the free end thereof.   13. 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) and haptic peripheral elements (16b) shaped like loops, said lens implant being: - positioned in the housing (13) delimited by the distal ends (11a, 12a) of tongues clipping (11) and thrust (12), - hooked, via one of its haptic elements (16b) around the "bridging" constituted by the approximation of the beaks (11c, 12c) of clipping (11) and pushing tabs (12); disposed in abutment, via a portion of the edge of said central optical element (16a), and its lateral parts being accommodated in the depression (15d) of the thrust plate, the IOL thus positioned and the packaging device being housed in a sealed package ensuring the preservation of the optical and physical qualities of the implant and packaged, this package may contain an aqueous solution contributing to this protection.   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 conditioning device according to any of claims 7 to 13, the upper (6) and lower (7) slots in the proximal portion of the cartridge, and the distal portions (11a, 12a) clipping tongues (11) and pushing tongues (12) have widths such that the push tongue (12) can pass through the upper (6) and lower (7) slots of the cartridge, while the clipping tab (12) can pass through said upper slot, but can not pass through said lower slot (7).