FR2873914A1 - Intraocular lens inserting process for cataract operation, involves transferring lens in injection cartridge by translation in case passage and inner surface of cartridge`s blade, and maintaining lens in cartridge when cartridge is closed - Google Patents

Abstract

The process involves positioning an intraocular lens (6) in a longitudinal passage (2) of a case (1). The lens is transferred in an injection cartridge (8) by translation in the passage and in the inner surface of one of blades of the cartridge, and maintained in the base of the cartridge, at the beginning of the removal of the case and the closing of the cartridge involving folding or compaction of the lens. The case (1) has a front open end to position one of the blades of the injection cartridge (8) in the plane of the sliding surface (3) of the passage, where the cartridge is maintained in an open position.

Description

Device and method for placing an intraocular implant

in an injection cartridge.

  The present invention relates to a device and a method for placing an intraocular implant in an injection cartridge, for the implantation of an artificial lens.

  The operation of the cataract is to extract from the eye the altered crystalline lens and implant in place of the latter, an artificial lens or intraocular implant commonly called IOL (Infra Ocular Lens).

  The extracapsular extraction technique of the lens by the phacoemulsification method has the particular advantage of requiring only a very small incision in the cornea which facilitates its healing.

  It is then necessary to place an artificial lens or intraocular implant in the eye, through this small corneal opening. Such an implant is usually made of a flexible material such as silicone, hydrophilic acrylic, hydrophobic acrylic.

  The technique currently most widespread and which seems to remain so for a long time is that of injection. According to this method, the implant is folded, by means of different devices, into a tube which then allows its transfer into the eye via the small incision made in the cornea.

  The size of the incision is an essential parameter in the healing and recovery time of the patient avoiding stitches and consequently postoperative astigmatism that can last several months.

  According to an interesting method of implementation of the injection technique, the implant or IOL is positioned in a hinged disposable cartridge for folding it into a more compact form and enclosing it in a tubular injection chamber. from which it is guided to the inside of the eye under the pressure of a reusable inserter. An injection cartridge of this type is, for example, described in US Pat. No. 5,499,987 A. Such a cartridge comprises a tubular transfer chamber made of two half-parts of concave section connected by a hinge-forming thinning allowing opening said chamber by spacing its half-parts, each of which is provided with a fin, one of the half-portions extending, at the front, by an injection tube which, when said cartridge is closed is located in extension of said transfer chamber.

  This method is interesting because its implementation requires the smallest incisions and its compatibility with different types of IOL (3 pieces, monobloc, shuttle, ...). For these reasons, it is very widespread.

  The phase that is problematic today with this method, is the introduction of the IOL in the injection cartridge. This phase is however crucial since it is it that defines the configuration of the implant in the tubular injection chamber and therefore mainly determines the proper operation of the insertion device of said implant. It requires many manipulations, with different instruments and requires some application. Moreover, during these manipulations, the implant is exposed and can come into contact with elements of its environment. The sterility of the implant is therefore conditioned to that of the elements coming into contact with it.

  US-6,129,733 A shows a device for placing an intraocular implant (IOL) in an injection cartridge. This document describes a very complex system for transferring an intraocular implant from an implant support into an injection cartridge, this device comprising a housing consisting of two articulated parts, one of which is arranged to receive a carrier. foldable implant removed from its sterile package and the other is shaped to allow the positioning of an injection cartridge. This system has several disadvantages: it comprises a large number of complex parts: a part with integrated hinge for the initial packaging, the foldable support, the cartridge holder and the cartridge itself; - the cartridge is necessarily specific; in particular, it is provided with edges that allow to grasp the IOL so that it can apprehend it while it is still widely open (this because the foldable support can not remain in the cartridge when the latter is closed ); there is a transfer of the foldable support between its initial conditioning and its positioning on the housing containing the injection cartridge; the number of manipulations is relatively high and the IOL is "in the open air" during this transfer: risk of falling, possibility of contact with surrounding elements; the product is a priori not flexible with respect to various lens sizes; it does not seem compatible with intraocular implants of the "shuttle" type.

  The object of the invention is in particular to provide surgeons with a device for assisting the placement of intraocular implants in the injection cartridges, without the aforementioned drawbacks.

  According to the invention, this object is achieved by means of a device comprising an elongated case provided with a longitudinal passageway for receiving an intraocular implant (IOL) and having a flat sliding surface and a rectangular section or substantially rectangular, so as to allow a longitudinal displacement of said implant by translation in said corridor, and a pusher can move in the latter to ensure this translation, the front end or transfer end of this case being shaped to allow the positioning of one of the two wings of an injection cartridge in the plane of the sliding surface of the corridor and for holding said cartridge in the open position during the transfer phase of the implant.

  More specifically, the device according to the invention comprises an elongated case comprising a front part and a rear part, this case being provided with a longitudinal section of flattened section, preferably rectangular, having a flat sliding surface and opening to the front portion of said case, a pusher housed with a longitudinal translatory aptitude in said passage and having a flattened section corresponding to the section of the latter, this pusher comprising a tongue extending forwardly and disposed at a distance from the surface prior to use of the device, between the front portions of the pusher and the case for receiving an intraocular implant or IOL, the front end of the wall of the case provided with the sliding surface of the passageway being set back with respect to the front end of the wall of said holster disposed facing the sliding surface which has a depression dimensioned to allow the positioning of one of the fins of an injection cartridge.

  According to the method of the invention, an intraocular implant is prepositioned, waiting for use, in the longitudinal corridor of a case having a front end or open transfer end, shaped to allow the positioning of one of the fins of an opening injection cartridge in the plane of the sliding surface of the passageway and for holding said cartridge in the open position and said implant is transferred into said cartridge by translation in said passageway and on the inner surface of said fin , by holding the implant in the bottom of the cartridge at the beginning of the removal stroke of the case and the closure of the cartridge causing the folding or "compacting" of the implant.

  The injection cartridge device or charger according to the invention provides many very interesting advantages: It constitutes the packaging of the IOL, which has the following advantageous consequences: to avoid any contact of the practitioner with the implant; it being transferred directly from its packaging to the injection cartridge; not to cause a significant additional cost compared to the currently used packaging; - to minimize the risk of falling of the implant during the transfer.

  É It can be used for three-piece implants (wire haptics) as well as for shuttle-type implants.

  É It is exploitable whatever the type of the lens.

  É It is easy to use (intuitive) and the handling of the transfer is very fast: the gesture of pushing on the pusher is linked to that of the closing of the cartridge.

  It does not require the use of other instruments; this has the effect of limiting the number of instruments to be sterilized and reducing the size of the preparation table.

  É The operator retains all the possibilities of control and possibly adjustment that the current practice allows him.

  It can be packaged in a blister filled with saline and is therefore compatible with hydrophilic materials.

  It does not change by established practices for the rest of the operating process due to the fact that it adapts to standard injection cartridges and does not require further investment.

  It is emphasized, on the other hand, that there is a difference in the kinematic schemes implemented in US-6,129,733 A and in the present invention.

  Whereas the system presented in the document US Pat. No. 6,129,733 A uses a mode of implementation similar to the manual practice (with instruments), that is to say a feed along the axis of revolution of the lens, the device according to the invention proposes to clip the IOL in the cartridge, by translating it on the plane of one of its fins.

  Since the majority of the implants have a haptic geometry that fits into a rectangle whose long side is parallel to the injection direction, the implant according to the invention, pushed by a surface also parallel to the direction of injection. injection, is well configured.

  This same surface, supplemented by that of the stopper which is parallel to it, is also used during storage during which the implant remains suitably oriented.

  This principle allows easy adaptation to different sizes of IOL, either by changing the position of the plug or the initial position of the pusher, or because the game introduced does not affect the positioning that is caught in the injection phase .

  The above and other objects, features and advantages will become more apparent from the following description and accompanying drawings, in which: FIG. 1 is an exploded and dive perspective view of a device for carrying out place of an intraocular implant or IOL, according to the invention.

  Figure 2 is an exploded perspective view and downwardly of this device.

  Figure 3 is a longitudinal sectional view of the device.

  Figure 4 is a detail view, on a larger scale and in longitudinal section of the front part of the device.

  Figure 5 is a sectional view along the line 5-5 of Figure 3.

  Figure 6 is a perspective view of an injection cartridge, of a type commonly used by surgeons for the placement of intraocular implants.

  Figures 7A, 7B, 7C are perspective views of three types of intraocular implants that may be used for the replacement of an impaired lens.

  FIG. 8 is a diagrammatic plan view illustrating the good positioning of the haptics of the various types of implants with respect to the cartridge transfer chamber.

  Figure 9 is a longitudinal sectional view showing the pre-packaged device in a sealed package.

  FIGS. 10A to 10F are schematic views showing the various phases of placing an intraocular implant in an injection cartridge.

  Figure 11 is a longitudinal sectional view of an alternative embodiment of the device in which the injection cartridge is pre-positioned at the distal end of the case.

  Figure 12 is a plan view of Figure 10.

  Figure 13 is a cross-sectional view along the line 13-13 of Figure 12.

  Figure 14 is a perspective view of the alternative embodiment illustrated in Figures 11 to 13.

  Referring to the drawings to describe an interesting example, although not limiting, implementation of the method and embodiment of the device according to the invention.

  This device comprises a casing 1 of generally elongate approximately parallelepipedal shape having an open front end 1a and a rear end 1b which can be closed. In this case, there is provided a longitudinal passage 2 of flattened section, preferably rectangular or approximately rectangular opening at the open front end of said case. This corridor comprises a flat sliding surface 3, constituted by the inner face of the wall or the large lower face of the case 1.

  In this corridor 2 is housed, with a longitudinal translational ability, a pusher 4 having a flattened section corresponding to the section of the corridor, preferably rectangular or substantially rectangular, so as to be able to slide without excessive lateral play in said corridor.

  In its front part, the pusher 4 is provided with a transverse rabbet 5 oriented towards the sliding surface 3 of the corridor 2. The height h of this rabbet is slightly greater than the maximum thickness of the intraocular implants usually used. in cataract surgery, while its length I is less than or equal to the half-diameter of the lenses 6 of said implants. In this way, the front end of the pusher 4 has a transverse tongue 4a extending forwardly, away from the sliding surface 3 lo of the corridor, and whose length is less than or equal to the half-diameter of the lenses or optical implants.

  On the other hand, the bottom of the rabbet 5 delimited by the tongue 4a constitutes a thrust surface 4b oriented transversely with respect to the passage 2.

  The front part of the sliding surface 3 of the passage 2 is provided with a transverse depression 7 whose height h 'corresponds to the thickness of a fin 8a of the injection cartridge 8 and whose length corresponds substantially to the width a fin 8a. In this way, when a fin of an injection cartridge 8 is positioned in the recess 7, its upper surface is disposed in the extension of the sliding surface 3 and flush with it.

  The front end 3a of the flat sliding surface 3 of the passageway 2 is set back with respect to the front end 1c of the large face 1d of the holster arranged facing the sliding surface 3.

  Advantageously, the front end 1c of the large face 1d has an edge inclined towards the inside of the case 1.

  Before use of the device, a space 14 is located between the front ends of the case 1 and the pusher 4 and in this space is housed the intraocular implant 6. On the opposite side to the pusher 4, the space 14 is closed by a removable cap 9.

  The large face Id or upper wall of the case 1, is provided with a longitudinal slot 10 to move the pusher 4 in translation by pressing a finger on the top of said pusher.

  One or more holes 11 are formed in the front part of the upper wall 1d, while one or more holes 12 are formed in the front part of the lower wall 1 e of the case 1.

  The top holes 11 and 12 below allow the filling of the cavity 5 receiving the IOL when the device is packaged in a liquid element (IOL acrylic hydrophilic).

  The bottom holes 12 allow the introduction of a viscous fluid on the sliding surface 3. This viscous fluid is introduced, with the aid of a syringe equipped with a very small diameter cannula, just before the implementation. place the IOL in the cartridge; the cartridge itself must be covered. The prediction of two holes 12 makes it possible to counteract excessive displacement of the implant under the action of the injected fluid. These holes open into the chamber 5, behind the reception and support position of the IOL so that it is not altered during its translation.

  The device thus produced and containing a preconditioned implant may be blistered 13 or other packaging (FIG. 9) for storage and transport.

  According to another interesting embodiment illustrated in Figures 11 to 14, the device may also be presented in a configuration in which the IOL and the injection cartridge are pre-positioned in the distal portion of the charger 1-4. Such a configuration can further reduce handling and, therefore, the risk of error and contamination.

  In this case, the IOL 6 is positioned in the space 14 and partially housed in the rabbet or chamber 5 and a fin 8a of the injection cartridge 8 is locked in the recess 7, while the second fin 8b of said cartridge is placed in abutment against the edge of the front end 1c of the upper wall 1d of the case 1, the cartridge being open at an angle of the order of 120. The cartridge 8 thus pre-positioned is held in place by a suitable retaining system (not shown). For example, it can be provided: - that the cartridge 8 is secured to the case 1, for example during molding, and has one or more areas of weakness to dissociate said case, once loaded; - that the cartridge is fixed by clipping to the distal end of the charger 1-4; to provide the depression 7 with a lug and a fin 8a of the cartridge 8 of a housing of this lug, so that the displacement of the pusher 4 towards the front can cause the release of the cartridge, for example by deforming the surface of said depression 7.

  Figure 6 shows an injection cartridge 8 of a type commonly used for the placement of an intraocular implant in the eye. This cartridge 8 comprises a tubular transfer chamber 8c made in two half-portions 8c ', 8c "of concave section, connected by a thinning 8d forming a hinge allowing the opening of said chamber 8c by spacing its half-portions 8c' , 8c ". Each of these half-portions 8c ', 8c "being laterally integral with a handling fin 8a, 8b, respectively and one of the half-portions 8c" extending, at the front, by an injection tube 8e which, when the cartridge is closed, is disposed in the extension of the transfer chamber 8c.

  Three types of IOLs commonly used for cataract surgery are shown in FIGS. 7A (3 pieces), 7B (shuttle) and 7C (monobloc), these implants consisting of a lens 6a and haptics 6b.

  Figure 8 shows the correct placement of the implants with respect to the cartridge, this good placement being defined by the position of the haptics. Indeed, the good placement of the haptics is fundamental to ensure a good placement of the implant in the capsular bag of the eye: for this, it is necessary that the haptic front (the closest to the injection tube) unfolds. in the injection tube. Because of their architecture, the cartridges ensure this deployment, as well as that of the rear haptic, if the haptics are positioned tangentially to the edges of the fins of said cartridges. It is known that the haptics are correctly positioned when the implant is brought so that the haptics departures are tangent to the edges of the fins of the cartridge. To do this, it is necessary that the implant is initially positioned correctly and that the thrust of the latter to the transfer chamber of the cartridge maintains this orientation, this function being provided by the thrust surface 4b of the pusher 4.

  FIGS. 10A to 10F illustrate the instructions for use of the injection cartridge magazine and the implementation of the method according to the invention.

  In Figure 10A, the magazine has been removed from its package 13 and the cap 9 has been removed. An injection cartridge 8 is presented at the front of the case. A fin 8a of this cartridge is positioned in the recess 7 formed at the front of the sliding surface 3, while the cartridge is held in the open position by the inclined edge 1c of the wall 1d of the case placed resting against the inner face of the second fin 8b of said cartridge. The displacement of the pusher 4 towards the front makes it possible to engage the implant 6 in the transfer chamber 8c of the cartridge 8 (FIG. 10B).

  Continuing the advance movement of the pusher makes it possible to introduce the entire implant 6 into the transfer chamber 8c of the cartridge 8 (FIG. 10C).

  It is observed that the opening angle of the cartridge 8 positioned at the front of the magazine 1-4, as defined by the functional surfaces 3 and 1c of the case 1, allows the "clipping" of the implant between the two cylindrical portions of the half-portions 8c ', 8c "exceeding the diameters of said half-portions passing through the pivot point, in this way the cylindrical portion thus defined relative to the half-portion 8c" acts as an abutment surface and, under the continuous action of the thrust surface 4b of the pusher 4 causes the folding start of the flexible implant 6. Here intervenes the tongue 4a of the pusher 4 which has the function of ensuring the orientation of the bending in the direction of the bottom of the transfer chamber 8c of the cartridge 8. As a result, since the implant is still abutting against said cylindrical portion, the pusher positions the opposite edge of the IOL which then relaxes in the other cylindrical half-portion 8c '.

  FIG. 10D shows the beginning of the output translation and the folding of the injection cartridge, causing the IOL held in the two half-parts 8c ', 8c "of the transfer chamber 8c to bend, by the cylindrical portions above.

  FIG. 10E shows the coordinated phase of exit and closure of the cartridge 8, effecting the folding or compacting of the implant 6 in an approximately cylindrical volume or of ellipsoidal section.

  FIG. 10F shows the complete separation of the injection cartridge 8 and the magazine 1-4 and the complete closure of said injection cartridge containing the implant in the folded state.

  The injection cartridge thus loaded can then be installed on a conventional inserter for transferring and positioning the implant in the capsular bag of the eye.

Claims (12)

- 13 - CLAIMS   A method for placing an intraocular implant in an injection cartridge, characterized in that an intraocular implant (6) is positioned in the longitudinal passage (2) of a shaped case recess having a forward end or an open transfer end (1a) shaped to permit the positioning of one of the vanes (8a) of an opening injection cartridge (8) in the plane of the sliding surface (3) ) of the passage (2), and for holding said cartridge in the open position, and said implant (6) is transferred in said cartridge (8) by translation in said passage (2) and on the inner surface of said fin (8a ), by keeping the implant in the bottom of the cartridge, at the beginning of the removal stroke of the case and the closure of the cartridge causing the folding or "compacting" of the implant.   2. Device for placing an intraocular implant in an injection cartridge, characterized in that it comprises a case (1) of elongate shape having an open front end (la), and provided with a longitudinal corridor (2) for receiving an intraocular implant (10L) and having a planar sliding surface (3) and a rectangular or substantially rectangular section, so as to allow longitudinal displacement of said implant by translation in said corridor, and a pusher (4) can move in the latter to ensure this translation, the front end or open transfer end (1a) of this case being shaped to allow, on the one hand, the positioning of one two fins of an injection cartridge in the plane of the sliding surface (3) of the passage (2) and, secondly, for holding said cartridge in the open position during the transfer phase of the implant.   3. Device according to claim 2, characterized in that the front end (3a) of the wall of the case provided with the flat sliding surface (3) of the passage (2), is set back with respect to the front end (1c) of the wall (1d) of said case disposed opposite the sliding surface (3).   4. Device according to one of claims 2 or 3, characterized in that the front end (1c) of the wall (1d) of the case disposed opposite the sliding surface (3) has an inclined edge in direction of the interior of said case.   5. Device according to any one of claims 2 to 4, characterized in that the front portion of the sliding surface (3) of the passage (2) is provided with a transverse depression (7), sized to allow positioning one of the fins (8a) of an injection cartridge (8).   6. Device according to claim 5, characterized in that the transverse depression (7) has a height (h ') corresponding to the thickness of a fin (8a) of injection cartridge (8) and whose length corresponds substantially to the width of said fin (8a).   7. Device according to any one of claims 2 to 6, characterized in that the pusher (4) comprises a transverse tongue (4a) extending forward and disposed at a distance from the sliding surface (3) of the corridor (2), this tongue (4a) having a length equal to or less than half the diameter of the lens (6a) implants (6).   8. Device according to any one of claims 2 to 7, characterized in that the pusher (4) is provided at the front with a rabbet (5) whose height is slightly greater than the maximum thickness of the lens (6a) of the implants (6) and whose bottom constitutes a thrust surface (4b) oriented transversely.   9. Device according to any one of claims 2 to 8, characterized in that the upper wall (Id) of the case (1) is provided with a longitudinal slot (10) for moving the pusher (4). .   10. Device according to any one of claims 2 to 9, characterized in that the upper wall (1d) and / or the lower wall (1c) are provided with one or more small openings (11, 12) opening into the space reserved for positioning the implant.   11. Device according to any one of claims 2 to 10, characterized in that the case (1) encloses an intraocular implant (6) pre-positioned in a space (14) formed between the anterior end (4a ) of the pusher (4) and the front end (1b) of said case, this space being closed by a removable cap (9) engaged in said front end.   12. Device according to any one of claims 2 to 10, characterized in that the case (1) encloses an intraocular implant (6) pre-positioned in a space (14) formed between the anterior end (4a ) of the pusher (4) and the front end (1b) of said case, and in that it also comprises a lo injection cartridge (8) pre-positioned, in the open position, in front of the case (1) and detachably attached thereto.