阅读说明：本技术 虹膜覆盖植入物 (Iris covering implant ) 是由 迈克尔·阿苏利纳 皮埃尔-弗朗索瓦·伊萨德 吉勒·博斯 大卫·恩夫润 奥雷利安·莫勒 于 2018-03-26 设计创作，主要内容包括：本发明涉及用于至少部分地覆盖眼睛的虹膜的虹膜覆盖植入物,该覆盖植入物包括主体(10),主体具有为不透明面的第一面以及位于相反的第二面上的至少一个附接构件,至少一个附接构件从主体向外延伸并被固定到主体,至少一个附接构件包括能够通过夹紧来将主体附接到眼睛虹膜的至少两个夹紧部分。(The present invention relates to an iris covering implant for at least partially covering an iris of an eye, the covering implant comprising a body (10) having a first face which is an opaque face and at least one attachment member on an opposite second face, the at least one attachment member extending outwardly from the body and being fixed to the body, the at least one attachment member comprising at least two clamping portions capable of attaching the body to the iris of the eye by clamping.)

1. An iris covering implant for at least partially covering an iris of an eye, the covering implant comprising a body having a first face that is an opaque face and at least one attachment member on an opposing second face extending outwardly from the body and secured thereto, the at least one attachment member comprising at least two gripping portions capable of attaching the body to the iris of an eye by gripping.

2. The cover implant of claim 1, wherein the opaque face extends at least in a plane that is substantially perpendicular to a direction of extension of the at least one attachment member relative to the second face of the body.

3. The cover implant of claim 1 or 2, wherein the at least two portions are movable away from each other in a plane containing the direction of extension of the at least one attachment member under the action of an external force, the body being elastically bendable within the plane when the body is subjected to the external force to move the at least two portions away from each other from an initial position, the at least two portions being able to return to their initial positions without any external force.

4. The cover implant of claim 3, wherein the body has at least two receiving portions each adapted to receive an instrument or a portion of an instrument for elastically bending the body.

5. The cover implant of any one of claims 1-4, wherein the at least one attachment member is integral with the body.

6. The cover implant of any one of claims 1-5, wherein the at least two attachment members are spaced apart from one another along a first direction that is substantially perpendicular to the direction of extension of the at least one attachment member relative to the second face of the body, the body having a thickness along the direction of extension of the at least one attachment member relative to the second face of the body, the thickness of the body decreasing in a region of the body between two regions where the at least two attachment members are disposed.

7. The cover implant of any one of claims 1 to 6, wherein the body comprises a frame provided with the at least one attachment member and a cover member assembled with the frame, the cover member comprising the opaque face.

8. The cover implant of claim 7, wherein the frame and the cover member are mechanically engaged with one another.

9. The cover implant of claim 8, wherein the frame has second receiving portions each adapted to receive the cover member.

10. The cover implant of any one of claims 6 and 7 to 9, wherein the frame comprises two beams spaced apart in parallel, the two attachment members being located on the two beams respectively.

11. The cover implant of any one of claims 7-10, wherein the cover member further comprises a mechanical portion assembled with the frame.

12. The cover implant of any one of claims 7 to 11, wherein the cover member and the frame are both elastically deformable.

13. The cover implant of any one of claims 1 to 12, wherein the body comprises a frame provided with the at least one attachment member and a cover member comprising the opaque face, the frame and the cover member being made of a single piece.

14. The cover implant of any one of claims 1-13, wherein the opaque face has at least one region that is an opaque optical face.

15. The cover implant of any one of claims 7 to 13 and claim 14, wherein the opaque optical surface belongs to an optical portion extending beyond the frame.

16. A surgical kit comprising a plurality of cover implants according to any of the preceding claims, forming a multi-part iris cover implant that functions as a septum when attached to an iris of an eye.

17. A surgical kit comprising a plurality of cover implants according to any one of claims 1-15, the plurality of cover implants forming a multi-part iris cover implant that functions as a partial or complete artificial iris when attached to an iris of an eye.

18. An assembly of a plurality of the cover implants of any one of claims 1-15, the plurality of cover implants forming a single iris cover implant that functions as a diaphragm when attached to an iris of an eye.

19. An assembly of a plurality of the overlay implants of any one of claims 1-15, forming a single iris overlay implant that functions as a partial or complete artificial iris when attached to an iris of an eye.

Technical Field

The invention particularly relates to an iris covering implant.

Background

The eyes of a young person may naturally focus from distant objects to near objects. The deep mechanism of this focusing is called the adaptation process. The adaptation process consists of three main aspects: first, as the object approaches, the eyeball converges, then for a given intensity, the degree of pupil constriction increases, and finally the lens shape is accommodated by ciliary muscle constriction.

As the eye naturally ages, it becomes increasingly difficult for the eye to adapt to near objects. As it ages, the subject gradually loses its near vision and can only create a clear image of distant objects. This natural visual effect is known as presbyopia. It is estimated that by 2020, approximately 20 million people will have to deal with this optical effect. Presbyopia is experienced as blurred vision and frequently occurs when a person is reading a document or working with a computer. Untreated patients can compensate by moving the observed substance farther than they were previously practicing. The source of presbyopia is aging of the lens, which becomes larger and stiffer and thus more difficult to deform, whereas convergence and pupil constriction appear unaffected.

Many attempts have been made to correct presbyopia. The most conventional and traditional solution is to use a pair of reading glasses: due to the maintained far vision, the subject may wear glasses to be able to read, for example, a book. Although this solution is not invasive at all, wearing glasses may be neither aesthetic nor practical for the patient, since he/she needs to wear and remove the glasses depending on the distance of the object he is looking at. To address these problems, multifocal and progressive spectacles have been developed. Multifocal and progressive lenses providing at least a first refractive correction for distance viewing and a second refractive correction for viewing near objects; vision at multiple distances is sometimes achieved with progressive curvature changes.

Surgical attempts have been made to permanently correct the symptoms of presbyopia, which are generally considered to be hallmarks of aging, in a more invasive manner and restore the range of vision without the need for glasses. Conventional treatment is to make a static adjustment of the refractive power of one eye of the person. Thus, the other eye is used for hyperopia, and the brain processes the two signals of both eyes to produce a new depth of vision suitable for both near-and distance-sighted images (monoscopy).

There are different ways to correct myopia of the eye. The cornea can be altered by, for example, reshaping the cornea with a laser or placing a refractive implant within the corneal tissue (corneal inlay). Another solution is to replace the lens with an implant that is adapted to a specific set of vision distances and is called a multifocal intraocular lens (or MIOL). This type of device includes different corrections for at least two specific distances. However, this type of treatment has the following drawbacks: for example, resulting in loss of brightness, halos, glare and glare in night vision.

It is also possible to note the original attempts to restore the field of vision, such as scleral implants, which focus for example on the release of zonular tensions without obtaining the desired performance.

However, none of the above solutions has proven satisfactory.

Disclosure of Invention

In view of the above, the inventors of the present invention have sought a new effective implant to compensate for presbyopia.

While seeking such a new implant, the inventors of the present invention conceived a new implant configuration and have discovered other applications for such a new implant configuration.

According to one aspect of the invention, a new iris implant configuration is an iris covering implant for at least partially covering an iris of an eye, the covering implant comprising a body having a first face that is an opaque face and at least one attachment member on an opposing second face, the at least one attachment member extending outwardly from and secured to the body, the at least one attachment member comprising at least two gripping portions capable of attaching the body to the iris of the eye by gripping.

The iris covering implant is adapted to be positioned over and attached to an iris of a human eye.

The or each attachment member is fixed or connected to the covering implant, which means that the attachment member(s) is not the only tool used to place and attach the implant onto the iris and subsequently removed. In contrast, the attachment member(s) remain in clamping engagement with the iris portion in situ for the entire duration of use of the implant in the eye. In other words, the attachment member(s) remain attached to the anterior surface of the iris in a permanent manner during use of the implant, as opposed to a tool. Thus, the use of such attachment member(s) does not mean that an external tool cannot be used to help position the covering implant on the iris.

The clamping portion of the or each attachment member may perform a clamping function on the iris, i.e. on a portion of the anterior surface of the iris, in particular on the ridge of the iris (the natural iris fold), to clamp the iris portion or ridge between the two facing portions. Thus, the cover implant can be secured to the iris without piercing or passing through the iris tissue. This allows removal of the covering implant without seriously damaging the tissue with the hole.

The two clamping portions are brought close to each other in their initial position (clamping position) to be able to clamp the iris ridge between the two facing portions. The two clamping portions may be positioned at a distance of less than 3mm, preferably less than or equal to 2mm, for example less than or equal to 2mm from each other. If the distance between the two facing parts of the or each attachment member is large, clamping of the iris ridge will not be possible or will prove to be very difficult.

It should be noted that the free end of the gripping portion, opposite to the end connected to the second face, may each have an enlarged portion or head having a shape suitable for firmly and safely gripping the iris ridge, for example having a flat surface facing the flat surface of the other gripping portion.

The iris has a shape of a disc or a ring, and the iris-covering implant is used to cover at least a portion of the iris regardless of the shape of the implant. Generally, the implant may be located on a radius of the iris and oriented toward the center of the iris.

The iris covering implant may have different shapes, such as in some cases the overall shape being a ring, angular sector or area, and the like.

Generally, an iris covering implant has two opposing faces: a first face that is opaque; and a second face provided with attachment means for cooperating with the iris of the eye, more specifically the front surface of the iris, to attach the iris-covering implant to the iris (the two functional areas of the body). The opaque face is then intended to be visible through the cornea of the eye. The first and second faces are defined as opposing faces, wherein the first and second faces are faces of the body, both faces oriented in opposite directions, one face for facing the cornea and the other face for facing a surface of the iris when the implant is attached to the iris. The two faces may not strictly extend one above the other. One face may even extend more than the other face so that the extended portion of the face does not overlap the other face.

Such an iris cover implant is effective and easy to mount on the iris (pupil margin) due to the at least one attachment member.

Furthermore, the iris overlay is not intended to come into contact with the iridocorneal angle, which avoids ocular hypertension and subsequent serious complications. The iris overlay is also not used to contact the corneal endothelium, which avoids endothelial failure and subsequent severe complications.

With such a covering implant, complications of the iris of varying severity can be avoided: infection, anterior uveitis, ocular hypertension, glaucoma, endothelial failure, corneal edema, and decompensation.

Examples of secondary complications of cosmetic artificial iris anterior chamber implants can be found in the case report of Yusrah sheikh, Sally american and Ali meaarza, BMC Ophthalmology, 201515: 97.

The covering implant is for placement into the anterior chamber of the eye, i.e., within the aqueous humor.

In the long term, this new implant construction does not create biocompatibility problems. After installation of such a covering implant, no inflammatory reaction occurs.

More generally, such covering implants may be used for optical enhancement of the eye, including compensation for presbyopia, regular refractive error, or regular astigmatism.

More specifically, such a cover implant may be used for presbyopia correction or compensation by forming a diaphragm for reducing the diameter of the hole of the constricted iris, usually simultaneously with other cover implants.

Alternatively, such a cover implant may be used for visual or cosmetic enhancement, modification or repair of the anterior surface of the iris (which may be considered "color of eye" through the cornea).

In such applications, the cover implant may be used alone or in combination with other cover implants, for example, to conceal iris deformities or to change color locally or completely.

In these applications, the iris covering implant is attached to the iris at a location such that the opaque face is above the iris. Here, the covering function does not require that the opaque surface extend beyond the inner edge of the iris.

When looking for a method to compensate for presbyopia, the inventors of the present invention noted that it is interesting to narrow the eye's aperture (pupil) to increase the depth of field. In particular, the inventors of the present invention noted that the ability of the lens to change its shape decreases over time, but pupil constriction remains in effect. The inventors of the present invention have also noticed that the phenomenon of pupil constriction is aggravated by elderly people who are no longer able to adapt to the crystalline lens. Similarly to the way the photographer increases the depth of field of the camera, pupil constriction causes the pupil diameter to decrease, thereby suppressing marginal rays. Thus, paraxial rays that are retained and pass through a fully constricted pupil can produce a sharp image on the retina for a wider range of viewing distances. The use of pinholes to suppress these edge rays is known as the pinhole (stenopic) effect or "pinhole effect". However, the inventors of the present invention have recognized that even if the elderly exacerbates the phenomenon of pupil constriction, this may not be sufficient to compensate for other effects of eye aging, including presbyopia.

Based on these statements, the inventors of the present invention have thought to further reduce the diameter of the contracted iris (enhance the natural pupil contraction) by using several iris covering implants, for example of the type described above, to correct presbyopia.

When the plurality of cover implants are installed on the iris, the plurality of cover implants are arranged in a radial distribution around the central aperture of the iris (pupil) and are attached to the iris. The plurality of cover implants may radially converge toward a center of the central bore.

Each cover implant may be attached to the anterior surface of the iris at a location such that at least one region of the optically opaque face of the cover implant forms a cantilever portion with respect to the inner edge of the iris, the cantilever portion defining the pupil on the outside. Thus, when viewed through the cornea, the opaque optical surface extends beyond the inner edge of the iris in the central aperture (pupil). The cantilever portion with the opaque optical area may be considered to be the diaphragm portion.

The cover implants may be arranged on the iris such that when the pupil dilates (for distance vision and/or in dark conditions) the cover implants are far from each other.

When the pupil constricts (which occurs for near vision and/or under daylight conditions), the cover implants are positioned close to each other to together form a diaphragm and further reduce the diameter of the natural, constricted central aperture of the iris.

By further narrowing the aperture of the naturally contracted iris, marginal ray suppression can be achieved, and depth of field (pinhole effect) can be increased without significantly and permanently degrading the photopic power of the implanted eye (e.g., brightness for distance vision must be maintained).

This diaphragm configuration can produce a pinhole effect that effectively improves near vision.

This pinhole effect is obtained only when needed, i.e. it is not permanent regardless of the position of the pupil, and the covering implant is always present on the iris and moves with it. When the pupil dilates, the cover implants move away from each other and thus do not create a pinhole effect. This effect may act approximately gradually as the pupil constricts. Thus, the implant may be considered dynamic in that the position of the implant in the eye changes with iris movement, and the technical effect of the implant is dynamically generated, i.e. during the contraction movement of the iris.

Due to this new iris implant configuration, there is no significant reduction in the amount of light for distance vision or low light conditions (intermediate vision) vision. The implant can be adapted to the conditions of brightness and focus. The implant adapts to the eye specificity of the patient and adapts dynamically so that vision at night or in dark conditions is not restricted and the pinhole diameter can fit perfectly (customized to the eye).

It should be noted that the portion of the body performing the optical function need not be a removable or removable portion of the body, but may be integrated in the cover implant.

According to other possible features:

the opaque face extends at least in a plane substantially perpendicular to the direction of extension of the at least one attachment member with respect to the second face of the body;

at least two portions movable away from each other under the action of an external force in a plane containing the direction of extension of at least one attachment member with respect to the second face of the body (this direction of extension being substantially perpendicular to the second face of the body and, if the two faces are parallel, this direction of extension may be perpendicular to the first face), the body being elastically bendable within the plane when subjected to the external force, so as to move the at least two portions away from each other from an initial position, the at least two portions being able to return to their initial position (clamped position) without any external force (this elastic bending movement may be repeated a plurality of times without causing any damage to the implant); the two facing portions are spaced apart from each other in their initial positions by a distance that allows sandwiching of the iris ridge between the two facing portions and are movable away from each other in a direction that tends to increase the initial distance between the two facing portions; this direction may be a combination of the axial direction (perpendicular to the two facing portions) and the direction of outward extension of the attachment member; in the bent position, the two portions are spaced apart from each other by a distance that places them on either side of the edge of the iris; it should be noted that due to the inherent properties of the overall body material (even though some parts of the body may be considered to facilitate bending of the body, not only one region of the body, but the entire body deforms during such bending; bending of the body generally does not exceed a given angular range, e.g. 90 °; generally the body cannot be bent such that the two extreme bent parts of the body contact each other (as in the folding movement of the sheets)), i.e. this is not a folding movement; the bending movement is carried out around a longitudinal direction (perpendicular to the above-mentioned plane) and the bending force can be exerted on two opposite peripheral edges of the body, which are spaced apart from each other along a transverse direction (which extend parallel to the longitudinal direction); thus, it is very simple to attach/fix the subject to one or more parts of the anterior surface of the iris, since this does not require complex deformations of the subject in different directions to achieve the attachment.

The body has at least two receiving portions each adapted to receive an instrument or a portion of an instrument for elastically bending the body; each receiving portion may take the shape of a groove that opens toward the outside of the body (i.e., in a direction away from the body);

-at least one attachment member is integral with the main body; this simplifies the concept of the covering implant compared to, for example, an attachment member which is subsequently fixed to the covering implant in a detachable manner;

-the at least two attachment members are spaced apart from each other along a first direction, which is substantially perpendicular to the direction of extension of the at least one attachment member, the body having a thickness along the direction of extension of the at least one attachment member with respect to the second face of the body, the thickness of the body being reduced in a region of the body between two regions where the at least two attachment members are arranged;

-the body comprises a frame provided with at least one attachment member and a cover member assembled with the frame, the cover member comprising an opaque face; the two-part body can be easily manufactured; such a configuration may customize the covering members, e.g., by selecting appropriate materials, coloring, etc., while the frame may be common to all covering implants (e.g., one frame for each covering member); when the cover member is fully opaque, the cover member covers the at least one attachment member from above (facing the iris according to a view taken through the cornea); when assembled, the covering member extends over the frame and covers at least a part of the frame, in particular at least the part provided with the attachment member(s); the frame may extend perpendicular to the direction of extension of the attachment member(s) in two planar directions; the covering member (which may, for example, be curved like a tile) may also extend in the same two plane directions and have a longitudinal extension that will cover (overlap or extend over) the entire longitudinal extension of the frame or at least the portion provided with the attachment member(s);

-the frame and the cover member are mechanically engaged with each other; the cover member may be engaged within the frame, or vice versa; the cover may be inserted into a slot defined in the frame;

the frame has two receiving portions, both adapted to receive the covering member; such receiving portions may be inwardly oriented with respect to the frame and may, for example, face each other; such receiving portions may take the shape of rails or grooves; the two receiving portions may be located on or near two opposite edges of the frame which are spaced apart from each other in the transverse direction (when the body has a longitudinal extension, these edges extend parallel to the longitudinal direction of the body);

the frame comprises two parallel spaced apart beams, wherein two attachment members are located on the two beams, respectively; the two parallel beams may be perpendicular to the longitudinal direction of the body and to the two opposite edges of the frame (when the existing feature is combined with the previous feature);

the covering member further comprises a mechanical portion assembled with the frame;

-the mechanical part is opaque, transparent or coloured to obtain a particular visual appearance;

-both the cover member and the frame are elastically deformable; this makes it possible to easily mount the cover member to the frame; the cover member may take the form of a flexible foil or tile;

-the at least one attachment member is a clamping member; the clamping member may clamp a portion of the anterior surface of the iris; several clamping members may be used;

the body comprises a frame provided with at least one attachment member and a covering member comprising an opaque face, the frame and the covering member being made of a single piece; when the cover member is fully opaque, the cover member covers the at least one attachment member from above (facing the iris according to a view taken through the cornea);

-the opaque face has at least one region that is an opaque optical face; this feature corresponds to an iris covering implant, in particular a diaphragm implant, and the iris covering implant has an optical function when implanted on the iris of an eye;

the opaque optical surface belongs to an optical portion extending outside the frame (in the longitudinal direction); here, the optical portion is desirably located above the pupil edge (beyond the inner iris edge) to reduce the diameter of the iris when the cover implant is attached to the iris; it should be noted that the entire opaque face of the covering member extends over the frame and beyond the frame, only the area extending beyond the frame having the optical function (the membrane); in another embodiment, the opaque optical surface constitutes the only opaque region of the cover member; the optical portion may extend longitudinally or axially to the mechanical portion;

the opaque optical part and the mechanical part may together form a single piece, which proves to be easy to manufacture.

Another aspect of the invention relates to an iris covering implant for at least partially covering an iris of an eye, the covering implant including a body having a first face that is an opaque face and at least one attachment member on an opposite second face, the at least one attachment member extending outwardly from the body, the at least one attachment member being capable of attaching the body to the iris of the eye for movement with natural movement of the iris. Thus, such iris covering implants (diaphragm implants) are dynamic implants (or parts of the entire implant) controlled by the motion of the iris. Such an iris covering implant may have an optical correction function and protrude into a central hole of the iris to perform the optical correction. The protrusion may intervene, for example reduce the pupil size, only when optical correction is required, i.e. only when the pupil is in the constricted position. Thus, the iris covering implant may act as a dynamic diaphragm in conjunction with the natural movement of the pupil. Any explanations and features given in relation to the above-described first aspect of the invention may also be applied here.

The present invention also relates to a surgical kit comprising a plurality (e.g., two or more than two or three) of covering implants as defined in any one of the two aspects described above (with the main features of this aspect or with at least some other features as possible). These covering implants are then placed within the eye, for example through a corneal incision, and then attached to the anterior surface of the iris by the above-mentioned attachment members using specially designed surgical instruments, such as suitable surgical forceps. The plurality of cover implants form a multi-part iris (intraocular) implant that functions as a diaphragm when attached to the iris of an eye (presbyopia treatment). When the multiple covering implants are all attached to the iris and the iris is sufficiently constricted, the multiple covering implants together provide the pinhole effect as described above. A multi-part iris implant is a dynamic implant controlled by the natural motion of the iris.

The present invention also relates to a surgical kit comprising a plurality (e.g., two or more or three) of cover implants as defined in any one of the two aspects described above (with the main features of this aspect or also with at least some other features being possible), the plurality of cover implants forming a multi-part iris (intraocular) implant that functions as a partial or complete artificial iris when attached to an iris of an eye by means of the above-described attachment members. Here, the cover implant is used to at least partially replace the visual aspect of the anterior surface on the iris. In practice, the covering implant is intended to at least partially cover the natural iris. This may replicate, alter or enhance the aesthetic/visual appearance of the natural iris surface. A multi-part iris implant is a dynamic implant controlled by the natural motion of the iris.

The invention also relates to an assembly of several (e.g. two or more or three) covering implants as defined in any of the two aspects described above (with the main features of this aspect or also with at least some possible other features), the plurality of covering implants forming a single iris (intraocular) implant which acts as a diaphragm when attached to the iris of an eye by means of the above-mentioned attachment members. The assembly is adapted to be placed in its entirety on the iris. A multi-part iris implant is a dynamic implant controlled by the natural motion of the iris.

The invention also relates to an assembly of several (e.g. two or more or three) covering implants as defined in any of the two aspects described above (with the main features of this aspect or also with at least some other features possible), the multiple covering implants forming a single iris (intraocular) implant which, when attached to the iris of an eye by means of the attachment means described above, serves as part or all of an artificial iris. The assembly is adapted to be placed in its entirety on the iris. A multi-part iris implant is a dynamic implant controlled by the natural motion of the iris.

Drawings

The detailed aspects described with reference to the drawings may accomplish the more general aspects described above and may therefore be combined with the more general aspects described above. It should be noted that the more general aspects described above may be applied to other embodiments than those described hereinafter.

Further features and advantages will be illustrated in the following description, given by way of non-limiting example only, with reference to the accompanying drawings, in which:

fig. 1 to 3 show a frame covering an implant according to an embodiment of the present invention;

fig. 4A to 4C illustrate a covering member covering an implant according to an embodiment of the present invention;

fig. 5A to 5C illustrate the principle of attaching a covering implant to the iris;

fig. 6A to 6C illustrate an assembling operation of the frame of fig. 1 to 3 and the cover member of fig. 4A to 4C;

FIG. 7 is a view of a modified embodiment of an attachment member;

FIGS. 8A-8C illustrate a unitary covering implant according to another embodiment of the present invention;

fig. 9A to 9C show different possible variant embodiments of the attachment member;

figures 10A to 10E show different possible configurations of the opaque optical portion of the covering implant;

11A-11C are different sequential views illustrating the pupil constriction and associated configuration of a cover implant attached to the iris for the cover implant of FIG. 10A;

figures 12A-12C are different sequential views showing the pupil constriction and associated configuration of a cover implant attached to the iris for the cover implant of figures 10D-10E;

figures 13A-13D are views showing different possible configurations of opaque optical portions of several cover implants attached to the iris;

figures 14A to 14D show the main steps of a possible surgical method for implanting a covering implant on the iris;

FIG. 15 shows a covering implant without optical functionality according to an embodiment of the invention;

FIGS. 16A-16D show different views of another covering implant with optical and covering functions, according to an embodiment of the present invention;

fig. 17 shows the covering implant of fig. 16A-16D positioned over the iris;

fig. 18 shows another covering implant without optical function positioned over the iris according to an embodiment of the present invention;

fig. 19A-19C schematically illustrate installation constraints of a covering implant according to an embodiment of the invention.

Detailed Description

In a first embodiment, an iris (intraocular) overlay implant performs an overlay or overlay function on the iris, the overlay implant being adapted to be secured to the iris. Because the iris is always covered by at least a portion or component of the implant, the term "covering the implant" will be used in the remainder of the description regardless of the embodiment and function/application of the implant.

Here, as shown in fig. 1 to 7, the covering implant is made of two parts. The cover implant is made of a biocompatible material or a combination or mixture of biocompatible materials. For example, the covering implant is made of silicon or hydrophilic acrylic or hydrophobic acrylic or elastomer and may be, for example, a cross-linked polydimethylsiloxane (a material suitable for medical use) that can be reinforced with silica or EMA (ethyl methacrylate) or HEMA (hydroxyethyl methacrylate) or a combination (copolymer) of the two aforementioned examples.

As shown in fig. 1-3, the cover implant 10 (only the assembled cover implant 10 is shown in fig. 6C) includes a body including a frame 12 provided with at least one attachment member.

The frame is made of a material or combination of materials that allow the frame to elastically deform. PMMA may be an example of a suitable material (generally transparent or colored).

In the present embodiment, there are two attachment members 14 and 16, the two attachment members 14 and 16 being arranged on one and the same side or side (here oriented downwards) of the frame. Here, the attachment member is made integrally with the covering implant, in particular with the frame. In variant embodiments, a single attachment member or more than two attachment members may be envisaged.

The frame 12 has a general axial or longitudinal extension along a longitudinal axis X and a transverse extension along a transverse axis Y. Frame 12 also extends perpendicular to plane X, Y along an axis Z defining its thickness (fig. 2).

The attachment members 14 and 16 extend outwardly from the frame 12 in a general direction (axis Z) that is generally perpendicular to the plane XY.

Here, the frame 12 comprises two cross-members 18 and 20, the cross-members 18 and 20 being axially spaced from each other along the axis X, leaving a central opening 22 between the cross-members 18 and 20. The cross members 18 and 20 extend along a transverse axis Y (fig. 1).

Each of the two opposite ends of each of the two cross members 18 and 20 is connected to two parallel longitudinal or axial support members 24 and 26. In another embodiment, more than two cross beams or a single beam connecting two support members may be envisaged. The single beam may have a longitudinal axis (X) and need not have the same extension as the support member.

For example, the frame is made of a single piece and may be made by an injection molding process or standard machining.

For simplicity, the following description will be made for the cross member 18, and the description is the same for the cross member 20.

When viewed in front or top view (fig. 1), each cross-beam has a relatively narrow central portion (e.g., central portion 18a of cross-beam 18) that becomes larger toward the two opposite ends 18b and 18c where it is connected to support members 24 and 26, respectively. Each beam has a curved profile in fig. 1 on two opposite lateral sides thereof (these sides extending transversely with respect to the longitudinal axis X). However, other front or top view shapes for the beam are contemplated.

Each cross member has a substantially flat and thin shape in the body portion 18d taken in a direction parallel to the axis Z when viewed in cross section (AA cross section in fig. 2). The body portion 18d includes a central portion 18a and a lateral extension on either portion thereof. In general, the body portion 18d may extend in a dimension that generally corresponds to the 2/3 length of the beam. However, other ratios are contemplated. Beyond the main portion 18d, the beam comprises enlarged lateral portions 18e and 18f, the lateral portions 18e and 18f having an increased, for example gradual, thickness (taken along the axis Z). This increase in thickness ensures a secure mechanical connection with the support members 24 and 26. In addition, this increase in thickness minimizes deformation (e.g., bending) in the laterally extending regions of the beam. In other words, the reduced thickness of the body portion facilitates deformation, such as bending, of the beam, which will facilitate the opening of the attachment member.

As described above, the thinned configuration of the cross beam in its central and main portions may elastically deform the frame in the plane of fig. 2, for example by bending as indicated by the two arrows.

In this embodiment, the two attachment members 14 and 16 are located on the underside of the central portions 18a and 20a of the beams 18 and 20, respectively.

Each attachment member may be a clamping member and may include at least two clamping portions or jaws 14a, 14b and 16a, 16 b.

In this embodiment, as shown in fig. 1 to 3, the two jaws are spaced apart from each other in their stable and undeformed initial position. The gap between the jaws may be wider or narrower depending on the object to be clamped between the jaws. Typically, the gap or distance along the transverse axis Y is less than or equal to 3 mm.

Fig. 5A very schematically shows the initial position of the clamping jaws 14a and 14b covering the implant 10. In fig. 5A to 5C, the covering implant 10 is fully assembled as in fig. 6C described later. The attachment principle shown in fig. 5A-5C is also applicable to a unitary covering implant.

When an external bending force is exerted on the two support members, here along the axis Y, the frame 12 bends in the plane of fig. 5A (also the plane of fig. 2 as indicated by the arrows), and the two jaws of each clamping member move away from each other, in particular along the transverse axis Y, so as to enlarge the gap (fig. 5B). The covering implant is moved towards the anterior surface of the iris (along axis Z) and the claws approach that surface to be positioned on either part of the ridge of the iris.

When the bending force is no longer applied, the frame returns to its original position of fig. 5A, and the claws may sandwich the iris ridge P (natural iris fold) between the claws (fig. 5C).

The axial support members 24 and 26 (fig. 1-3) each have a transverse profile or cross-section that may be the same along the entire length or may purposefully exhibit some controlled irregularities locally. This controlled irregularity can serve as an axial stop for the second portion of the covering implant body when the second portion (covering member) of the covering implant body is axially engaged into the frame.

In this embodiment, the axial support members 24 and 26 may perform a first function for receiving a surgical instrument or a portion of a surgical instrument (e.g., forceps) that may exert an external bending force on the frame to bend the frame and open the jaws as described above.

In this regard, the axial support members 24 and 26 may each include a first receiving portion 24a and 26a that is oriented outwardly (i.e., opposite the beams 18 and 20) relative to the frame (fig. 2 and 3).

Here, the first receiving portion takes the shape of a longitudinal or axial groove that opens out to the outside of the frame and extends along the length of the support member. The two grooves open out in two opposite directions, respectively. Each groove has a concave shape that can adapt in a complementary manner to the shape of the instrument or of a part of the instrument. The opening of the groove may be centered in the plane XY in which the two beams 18 and 20 extend. In an alternative configuration, the grooves may alternatively be oriented upwardly, i.e. may have openings forming an angle with the above-mentioned plane.

Further, the axial support members 24 and 26 may each include a second receiving portion 24b and 26b that is substantially opposite the first receiving portion. The two second receiving portions face each other with a lateral space defined therebetween. The two second receiving portions more particularly define, together with the upper side or upper faces of the cross beams 18 and 20 (the upper side lying in the XY plane), a housing or slot between the two second receiving portions adapted to receive the covering member.

The second receiving portions 24b and 26b may take the form of rails or grooves that are oriented inwardly with respect to the frame (i.e., generally toward the beam). The second receiving portions 24b and 26b are more particularly located at a distance from the upper side of the beam (fig. 2). In the present embodiment, the second receiving portions 24b and 26b are each formed in the same portion of the support member as the first receiving means. More specifically, each second receiving portion may be formed by one of two edges defining adjacent outwardly-oriented grooves (first receiving portions). The edge is shaped to change orientation towards the inside of the frame and to form a bend. The bend thus defines an inwardly directed recess and may accommodate the cover member.

The cover implant body 10 also includes a cover member 30 (fig. 4A-4C), the cover member 30 being for assembly with the frame 12. The invention may also relate to covering implants having more than two parts, for example the frame and/or the covering member may be made of more than one part.

The cover member 30 includes two portions (see fig. 4A, which is a top or front view):

-a mechanical portion 32; and

an opaque optical portion 34.

In this embodiment, the two parts together form a single piece. Both portions may have the same thickness along the Z-axis (fig. 2). Here, the cover member may take the form of a foil, e.g. a relatively thin foil.

The mechanical part 32 will be assembled with the frame 12 by means of the above-mentioned second receiving parts 24 and 26.

The mechanical portion 32 and the opaque optical portion 34 are aligned with each other along the longitudinal axis X. Both the mechanical part 32 and the opaque optical part 34 extend in a plane XY (which is parallel to the extension plane of the two beams 18 and 20).

Here, the covering member visible in fig. 4A has a face (upper surface) with two areas corresponding to the portions 32 and 34, respectively. The upper surface forms a first face of the frame opposite a face of the frame carrying the attachment members when the cover member is assembled with the frame.

The mechanical portion 32 may be light transmissive and maintain the original form of the iris (and thus, the corresponding first region of the upper surface of the cover member is not non-transparent). Alternatively, mechanical portion 32 may be colored or textured to create a visual effect (e.g., a pigment like an iris). Thus, the respective first region of the upper surface of the cover member is opaque.

When viewed from above (as shown in fig. 4A), the mechanical portion 32 has a generally rectangular shape including two generally parallel longitudinal edges 32a, 32b and a rear edge 32c having a convex shape.

Opaque optical portion 34 extends axially to the front region of mechanical portion 32 in a suitable shape that can vary depending on the embodiment. The portion 34 has the effect of being opaque (i.e., opaque to light) to create a pinhole or pinhole effect. Here, the second region 34a of the upper surface of the cover member is opaque. Generally, portion 34 may be opaque throughout its thickness (fig. 4A and 4C) such that when cover implant 10 is installed over the iris of an eye, portion 34 will be oriented in the direction in which the eye is viewing. Accordingly, opaque optical portion 34 is configured to receive incident light and block corresponding light. In a preferred embodiment, portion 34 is a black optical portion. In alternative embodiments, other opaque visual appearances, such as colored, tinted, etc., for face 34a are contemplated.

Here, the opaque optical portion 34 has two converging edges 34b and 34c, the two converging edges 34b and 34c extending from the longitudinal edges 32a and 32b, respectively, and terminating in an end edge 32d extending in the transverse direction and connected to the two oblique edges 34b and 34 c.

When all of the cover implants are installed on the iris around the pupil of the eye with the pupil in its most contracted position (as will be seen later), edges 34b and 34c have a geometry that is compatible with the geometry of the edges of the other opaque optical portions of the adjacent cover implants. Here, the inclination angle of the edges is the same for all opaque optical part edges of the covering implant, so that two adjacent converging edges of two adjacent covering implants are in contact. Thus, in this embodiment, no light can pass between two adjacent edges. Fig. 11C shows this pupil position with all of the covering implants 10 in close relationship to each other. It should be noted that in other cover implant configurations, light can pass between adjacent cover implants without adversely affecting the pinhole effect. This is particularly the case when the gap between adjacent covering implants represents a small and negligible portion (e.g., about 3% or 5%) of the overall septum.

Here, the end edge 34d has a concave shape in plan view which is able to reproduce as much as possible a generally circular profile overall when all the covering implants are mounted on the iris of the eye and the iris is in the most constricted position of the pupil.

In other words, when all the covering implants are in close relationship to each other (most constricted position of the pupil), the opaque optical portion forms and acts as a whole diaphragm that is as uniform as possible (continuity of opacity).

Different other possible shapes of the opaque optical part will be described later.

As shown in fig. 4A, opaque optical portion 34 is bounded by a line 34e, which line 34e is located at the boundary of mechanical portion 32 and separates the two portions. Line 34e has substantially the same curvature as edge 34d, defining a portion of a loop or annulus therebetween. All of these opaque portions, placed side-by-side at the most constricted location of the pupil, form a continuous opaque ring or annulus (the septum of fig. 11C).

As shown in fig. 4A, the length or axial extension of the optical portion 34 is less than the length or axial extension of the mechanical portion 32 and may be, for example, half the length of the mechanical portion 32. For example, the total length of the two parts is 2.22 mm.

The cover member is elastically deformable, i.e. herein by bending about a longitudinal axis of the cover member (parallel to axis X). The bending movement is performed in planes Y and Z.

Generally, the entirety of the cover member 30 extends in a plane (plane XY). However, as shown in fig. 4B and 4C, the cover member 30 is elastically deformed to be assembled with the frame, which will be seen later. This is because the beams 18 and 20 have convex lateral portions (see fig. 2). After the covering member is elastically deformed by bending and assembled with the frame, residual stress remains inside the covering member so that it can be held in place within the frame.

As shown in fig. 4B and 4C, the cover member 30 has a generally curved shape (e.g., as a tile) along its longitudinal axis in its initial non-deformed position.

Here, the cover member 30 is flexible, and may be made of, for example, silicon or hydrophilic acrylic or hydrophobic acrylic or elastomer.

Fig. 6A to 6C show an assembly process of the cover member 30 and the frame 12.

In fig. 6A, the cover member 30 is held in a slightly folded configuration by the forceps and is moved along the longitudinal axis X toward the frame with the rear region (edge 32c) facing the frame. The frame is placed with the second receiving portions 24b and 26b of the frame oriented upwardly and the attachment members oriented downwardly. It should be noted that the frame 12 has no front and rear (however, this may be the case for other frame embodiments), which makes the assembly process easier and faster.

Prior to any assembly operation, the cover member 30 is bent as described above (this is done using conventional forceps as shown in fig. 6A) to form a curved shape that generally corresponds to the internal frame profile defined by the upper surface of the frame (the upper surfaces of the beams 18 and 20) and the raised lateral portions 24b and 26b of the frame (e.g., the flared internal shapes of the lateral support members 24 and 26). In cross section, the internal frame profile is generally U-shaped and defines an open shell for receiving the cover member 30.

The longitudinal edges 32a and 32B engage or are inserted into the second receiving portions 24B and 26B above the cross members 18 and 20, and then the longitudinal edges 32a and 32B are slid along these portions (e.g., in rails or grooves) as shown in fig. 6B.

The cover member 30 is pushed axially until the opaque optical portion 34 substantially reaches the free ends of the second receiving portions 24b and 26b (fig. 6C). Suitable local structuring(s) may be provided inside the second receiving portion to prevent the cover member 30 from sliding in the axial direction. For example, a lug or slightly conical shape formed by the two second receiving parts of the set may be used.

When the cover member has been assembled with the frame, the two parts are held together by means of friction and contact pressure.

Thus, opaque optical portion 34 extends axially (along axis X) out of the frame as a cantilever beam. The above is applicable regardless of the shape of the covering member (especially, the opaque optical portion). This configuration may attach the cover implant at the following locations on the iris: such that only the opaque optical portion extends beyond the iris edge or pupil edge (see, e.g., the relative position between the cover implant 10 and the iris edge E in fig. 11A).

Note that in fig. 6C, the rear portion of the mechanical portion 32 also protrudes from the frame to serve as a weight portion. In other embodiments, the mechanical portion may be flush with the frame.

Other embodiments not shown herein may include an inverted configuration in which the frame is engaged inside the cover member. The cover member may be designed to contain a receiving portion for receiving the frame. For example, two receiving portions may extend from two substantially parallel edges of the covering member (e.g. edges 32a and 32b), respectively, e.g. in a direction perpendicular to the covering member, and may cover the frame placed below as a cap on three or four sides (an upper side and two downwardly extending side sides), wherein a possible oblique terminating portion extends below the frame to form the lower side. The assembly of the cover member and the frame member may be achieved by axially engaging the frame into the lower receiving portion of the cover member.

It should be noted that the assembly process described above is equally applicable to any other covering implant embodiment that includes a frame having a different configuration and possibly a covering member. For example, the frame may have only one cross-beam or more than two cross-beams as already envisaged above.

Fig. 7 shows a variant embodiment of the frame 40 with a single attachment member. Here, the attachment member is a clamping member 42 extending axially from one cross beam 44 to the other cross beam 46.

The clamping member 42 has two axially extending gripping portions or jaws, the function of which is the same as the jaws 14A and 14b in fig. 5A to 5C. Each jaw is attached to the lower surface of both beams. In this embodiment, all other components of the frame are identical to the components of the previous frame.

It should be noted that in other variant embodiments, the attachment members may be arranged differently with respect to each other, for example, the attachment members need not be arranged along the same axial direction of the frame (along the axis X) but in laterally offset positions. The embodiment of fig. 7 and its variants can be applied to any other covering implant embodiments and variants as mentioned above or below.

Fig. 8A and 8B illustrate an iris covering implant 50, the iris covering implant 50 including a body that is made as a single piece for ease of manufacture and implementation by a surgeon. The body includes an integrally formed cover member 52 and frame 54. Here, the frame has no second receiving portion. The cover member 52 has a mechanical portion 52a and an opaque optical portion 52b, and the mechanical portion 52a and the opaque optical portion 52b may have the same features and advantages as the embodiment and the modification including the two-part body. The frame 54 also includes an attachment member 56, the attachment member 56 having the same features and functions as the embodiment and the modification including the two-part main body. The underside of the frame is recessed between the two attachment members to provide flexibility to the frame (not shown here). All the above description is also applicable to the present embodiment. In particular, the different attachment member configurations mentioned above or below may equally apply to the embodiment of fig. 8A-8B.

Fig. 9A-9C illustrate a number of possible configurations of an attachment member secured beneath the frame of an iris covering implant. Fig. 9A to 9C show a clamping member having two spaced apart clamping portions or jaws of different sizes.

In fig. 9A, the frame 60 is provided with a clamping member 62, the clamping member 62 having two opposed heads 62a and 62b, the heads 62a and 62b being connected to the underside of the frame 60 by respective downwardly extending arms 62c and 62 d.

In fig. 9B and 9C, the respective frames 70 and 80 have clamping members 72 and 82, the clamping members 72 and 82 having increasingly larger heads and longer arms.

Other possible configurations are conceivable, for example with different head shapes, different numbers of gripping portions or claws, etc.

For the foregoing embodiments, the attachment member may be located below the central portions of the two spaced apart cross beams or may be arranged at another location. As shown in fig. 7, a single attachment member may be provided under the frame. The shape of the frame may also vary. All of the above-described matters regarding the attachment member(s) (especially matters with reference to fig. 5A to 5C) may also be applied thereto.

It should be noted that in fig. 9A to 9C, the opposite first receiving portions of each frame have been schematically represented as symmetrical grooves with respect to the median planes X and Y of the cross-members.

In the current embodiment of fig. 9A to 9C, the body (frame and cover member) covering the implant can be made in one piece and therefore does not require a second receiving portion.

However, fig. 9A to 9C are also applicable to a covering implant in which the body is two-part as in fig. 1 to 7.

The attachment member of fig. 9A-9C may be used in any of the foregoing embodiments and variations.

Fig. 10A to 10E show a number of possible configurations of the cover member mounted to the frame 12, including the cover member of fig. 10A already described.

Fig. 10B-10E show different cover member configurations in which the mechanical portion 32 remains the same as in fig. 10A, while the opaque optical portions are different from each other and from the opaque optical portion 34.

In fig. 10B, the cover member 30 'has a generally T-shape with the opaque optical portion 34' corresponding to the crossbar of the T-shape.

The opaque optical portion 34 'has a generally curved shape, such as a bean shape, with a central curved region 34' a and two side regions 34'b and 34' c, which, when viewed from above, extend laterally beyond the portion 32 and the frame 12 in an open manner. The central bending region 34' a is axially aligned with the mechanical portion 32 when viewed from above.

For portion 34 in fig. 10A, portion 34' has rounded edges (no sharp corners). For the same reason, the central curved region 34' a has the same type of curvature as the portion 34.

The side regions 34'B and 34' c do not lie in the plane as in fig. 10B.

Figure 10C shows a front view of the entire covering implant taken from arrow F in figure 10B (from the end side of the septum where the opaque optical portion 34' is located). In this figure, the side regions 34'b and 34' C are inclined with respect to an XY plane P '(where the XY plane P' is horizontal in fig. 10C) in which the beams 18 and 20 extend substantially at least in their main central portions. In this inclined position, the lateral zones 34'b form upper zones extending above the plane P' and the lateral zones 34'c form lower zones extending below the plane P'.

This configuration makes it possible to appropriately arrange adjacent opaque optical portions during the closing of the diaphragm (when the pupil is shrinking) so that the opaque optical portions do not mechanically interfere with other portions. Thus, adjacent opaque optical portions may partially overlap when viewed from above.

This configuration allows for the provision of an effective and uniform opaque septum or covering with all adjacent opaque optical portions covering the implant.

In fig. 10D, the cover member 30 "has an asymmetric shape when viewed from above as with the cover members 30 and 30'. In contrast, the cover member 30 "has a generally L-shape with the opaque optical portion 34" extending laterally. The opaque optical portion 34 "has a central region 34" a that is axially aligned with the mechanical portion 32 when viewed from above. Opaque optical portion 34 "also has side regions 34" b that extend laterally in an oblique and forward direction (as viewed from above) relative to the alignment axis of portions 34"a and 32.

Opaque optical portion 34 "has a curved end edge 34" c, which is generally concave along its length, so as to reproduce a generally circular profile when all of the covering implants are adjacent to one another in the most closed configuration of the overall septal implant (full pupil constriction).

More specifically, opaque optical portion 34 "has a double recess, rather than a single recess of opaque optical portions 34 and 34'.

Fig. 10E shows a rear view (view along arrow G of fig. 10D) of the cover member 30 ″ without the frame 12.

As shown in this lateral view, opaque optical portion 34 "does not lie in the plane of opaque optical portion 34', but is angled from a plane P" (here, a horizontal plane) in which the mechanical portion generally lies.

This configuration can properly arrange adjacent opaque optical portions during septum closure (when the pupil is shrinking) so that the opaque optical portions do not mechanically interfere with other portions. Thus, adjacent opaque optical portions may partially overlap when viewed from above.

This configuration allows for an effective and continuous opaque membrane or covering to be provided with all adjacent opaque optical portions covering the implant. All of the above described with respect to fig. 1-9C (e.g., attachment member(s), two-part or one-part cover member) may also be applied to the embodiments of fig. 10A-10E.

Fig. 11A-11C illustrate a plurality of iris covering implants 10 implanted (particularly attached) on the anterior surface of a human iris I. When the plurality of covering implants 10 are not implanted on the iris, the plurality of covering implants 10 form a surgical kit ready for use by a surgeon.

In a variation, the surgical kit may include a separate cover member and a separate frame that need to be assembled together prior to any iris implantation by the surgeon (when the cover implant is not a single piece).

Fig. 11A to 11C show different positions of the pupil.

In the initial expanded position of fig. 11A (fully expanded), the cover implant 10 is radially disposed relative to the center of the central aperture O1, wherein the longitudinal axes (X) of the cover implant 10 are radially oriented and away from each other.

The central aperture O1 defined by the iris sphincter margin E is at its largest diameter (e.g., 7 mm).

The cover implant 10 has a relatively small opaque optic portion 34 so that in the expanded position where the cover implants 10 are spaced apart from one another, the cover implant 10 can be considered to not affect vision.

In fig. 11B, the pupil is partially constricted and the central hole is reduced to O2 (reduced diameter of 4.5mm, for example).

The cover implant 10 is moved by movement of the iris and the cover implants 10 are brought closer to the center of the hole and away from each other (movement of the dynamic implant is controlled by natural movement of the iris).

In fig. 11C, the pupil is fully constricted and the central hole is reduced to O3 (reduced diameter of, for example, 3 mm).

The cover implants 10 contact each other two by two or in close proximity such that the opaque optical portions 34 together form a substantially continuous opaque membrane or region (e.g., here a band region) surrounding the puncture O3. This creates a pinhole or pinhole effect, thereby increasing the visual depth.

Here, since the shape of the opaque optical portions 34 is adjusted to be positioned side by side in the same plane, close contact or proximity between adjacent covering implants 10 is possible.

Fig. 12A-12C illustrate the multiple iris cover implants 30 "of fig. 10D-10E implanted (particularly attached) on the anterior surface of a human iris I and having the same pupil movement as shown in fig. 11A-11C.

In contrast to covering implant 10, covering implant 30 "is not in a planar configuration due to their upwardly inclined or convex side regions 34" b (see fig. 10E).

In the expanded position of fig. 12A, the mechanical portions 32 of the covering implant 30 "are spaced apart from one another, while the adjacent opaque optical portions 34" are in close proximity to one another. However, this is not important because the hole O1 is large enough.

In fig. 12B, cover implants 30 "overlap each other due to their laterally extending opaque optical portions 34", particularly due to the raised side regions 34"B of opaque optical portions 34". The side region 34"b of each opaque optical section 34" partially overlaps the central region 34"a of the adjacent opaque optical section 34" at a left position. This configuration creates a substantially continuous opaque annular or ring-shaped septum around the aperture O2 (which thus initiates the needle-hole effect process), while in the corresponding fig. 11b, the cover implants 10 are moved away from each other (no needle-hole effect has yet occurred). In fig. 12B, the mechanical portions 32 covering the implant 30 "are a distance apart as shown in fig. 11B.

In fig. 12C, the cover implants 30 "are closer to each other as the pupil narrows to aperture O3. Covering implants 30 "are in contact with each other two by two or in close proximity to each other through mechanical portions 32 (as shown in fig. 11C). The side regions 34"B of the opaque optical portion 34" are no longer arranged along the ring or ring shape of fig. 12B. The side region 34"b is now angularly offset toward the outside of the aperture O3, i.e., oriented outwardly from the annular shape.

Fig. 13A-13D illustrate different configurations of the opaque optic in the most constricted position of the pupil. The diameter of the constricted pupil is denoted by D.

In these figures, the opaque optical portions may overlap two-by-two (because the opaque optical portions are not planar in configuration) without overlapping in a regular manner.

All of the ends or terminal edges of these opaque optical portions at least partially face the central aperture O3 of the pupil when the respective cover implants are brought into proximity with each other.

Importantly, the contour of the central aperture O3 bounded by these end edges lies within an annular region AZ centered on a diameter or circle D1 corresponding to the target diameter of the septum at the most constricted pupil location to achieve the desired small aperture effect. The zone Z is bounded on the outside by two circular lines C1 and C2, which represent tolerance margins with respect to the target D1, C1 and C2.

In fig. 13A, the opaque optical portions have a configuration including a concave end edge 34d as in fig. 4A, but the opaque optical portions are inclined with respect to the XY plane configuration so as to be able to overlap as shown in fig. 13A. The opaque optic is distributed to form a contour S1 that defines an aperture O3, the shape of which aperture O3 is irregular but contained within zone Z.

In fig. 13B, the opaque optical portion has a configuration including a straight end edge 34'd and is inclined with respect to the XY plane configuration so as to be able to overlap as shown in fig. 13B. The opaque optic is distributed to form a contour S2 that defines an aperture O3, here the shape of aperture O3 is regular (hexahedron) and is contained within zone Z.

In fig. 13C, the opaque optical portion has a configuration in which: the end edge 34"d is uneven and the opaque optical portion is tilted relative to the XY plane configuration to enable overlapping as shown in fig. 13C. The opaque optic is distributed to form a contour S3 bounding an aperture O3, where O3 is irregular in shape and contained within zone Z.

In fig. 13D, the opaque optical portion has a configuration in which: the end edge 34' "D has a concave shape and the opaque optical portion is tilted relative to the XY plane configuration to enable overlapping as shown in fig. 13D. The configuration of the opaque optical portion has an inverted shape (with the lateral extension to the right of the central region 34 "a) compared to the configuration of the opaque optical portion in fig. 10D and 10E. The opaque optic is distributed to form a contour S4 that defines an aperture O3, where the shape of aperture O3 is irregular and is contained within zone Z. Everything described with reference to fig. 11A-13D is also applicable to any other blanket implant configuration as described above with reference to fig. 1-10E.

Fig. 14A-14D illustrate the main steps of a possible surgical method for implanting a plurality of iris covering implants, such as any one of the above-described covering implants (e.g., covering implant 10), on the anterior surface of iris I.

In this embodiment, the cover implant may form part of a surgical kit.

In a first step (fig. 14A), the cornea Cr of the eye is incised, for example using a conventional surgical instrument such as a scalpel 100. Alternatively, a femtosecond laser may be used to form the notch Inc. The incision may be a limbal self-sealing clear corneal tunnel incision or a self-sealing scleral tunnel incision. The width of the cut may vary between 1mm and 4 mm.

In a further step (fig. 14B), another instrument 110, such as a special folding forceps, is used to grasp the covering implant 10 and introduce the covering implant 10 through the incision Inc.

The forceps include a pair of arms 112 and 114, with the arms 112 and 114 contacting the sides of the cover implant 10 along the longitudinal edges of the cover implant 10 (support members 24 and 26). In particular, the arms 112 and 114 engage into the respective first receiving portions 24a and 26a (which have a shape adapted to the shape of the arms, i.e. a semi-cylindrical shape for receiving a cylindrical or substantially cylindrical shape) to carry the covering implant 10.

Alternatively, the covering implant 10 may be loaded into a dedicated cartridge syringe and then inserted into the anterior chamber of the eye through a corneal or scleral tunnel incision.

When the cover implant 10 is positioned over the iris (fig. 14B), the forceps may be grasped at the desired position such that arms 112 and 114 apply a grasping force to the first receiving portions 24a and 26a of the cover implant as indicated by the enlarged opposing arrows in fig. 14C. This clamping action causes the covering implant to elastically bend as described with reference to fig. 5A to 5C (the bending motion occurs around the longitudinal direction). The attachment members 14 and 16 are then opened over the radial ridge of the iris (the natural fold of the iris surface) P to clamp in place adjacent the pupil edge E.

Thus, the cover implant 10 is moved toward the radial ridge (e.g., downward if the patient is in a horizontal position) until the radial ridge is located between the two gripping portions or jaws. After correct positioning on either part of the ridge P, the clamping action may be stopped so that the two clamping parts or jaws may clamp the ridge as shown in fig. 14D, with the result that the covering implant frame is elastically returned. Thus, the cover implant is released from the instrument and positioned as shown in fig. 11A, with the frame 12 and mechanical portion 32 positioned over the iris and the cantilevered opaque optical portion 34 positioned over the pupil's aperture O1.

The same process is repeated as many times as the number of the covering implants 10 to be implanted (see fig. 14B).

It should be noted that the radial and longitudinal positioning of the covering implant can be guided by a dedicated corneal marker impregnated with sterile biocompatible ink to indicate the central optically clear area (minimum membrane diameter) and any suitable number of equally spaced radii, or by any other optical means including projecting a visible laser pattern through the cornea onto the surface of the iris.

More generally, the surgeon may use a positioning assistance system through the cornea that includes, inter alia, a light-guided target (e.g., a laser having a visible wavelength) that represents the optimal position of the implant on the iris.

This method can be performed with the pupil in its more constricted position to optimize implant positioning, with an artificial membrane of minimum diameter at this position, and with relative positioning of the implant that ensures no mechanical obstruction.

Generally, the opaque optical portion of the iris covering implant (or at least the opaque optical surface of the covering member) can be designed according to various geometries (see, e.g., fig. 10A-10E, 13A-13D, and 16-17) to optimize the optical continuity of the dynamic diaphragm effect as the pupil diameter changes with light adaptation or adjustment. The shape of the opaque portion (or at least the opaque optical face of the cover member) may include an additional oversized flange, which may be beveled to create an overlapping effect with the adjacent cover implant.

Fig. 15-18 illustrate other applications of the novel iris-covering implant according to the present invention.

Fig. 15 shows an embodiment of an iris covering implant 120, which iris covering implant 120 is intended to cover the iris only partially (where the optical diaphragm function is not present).

The cover implant 120 includes a cover member 122 corresponding to the cover member 32 of fig. 4A and a frame 124 corresponding to the frame 12 of fig. 1-3, and the frame 124 is assembled with the cover member 122, for example, as described above. The cover member 122 has an opaque face (the upper surface being visible in plan view; the attachment members are on the opposite face of the frame) and may be completely opaque. Alternatively, the cover implant 120 may be made as a single piece.

The axial extension (along axis X) of the covering member 122 and possibly of the frame 124 may be elongated to cover a greater area of the anterior surface of the iris.

Fig. 16A-16D illustrate embodiments of assemblies of several cover implants 132 and 134 (here two facing segments are shown, e.g., each having a U-shape, although in alternative embodiments more than two segments may be used), the cover implants 132 and 134 forming a single intraocular implant, here serving as both a diaphragm and a partial artificial iris (iris cover). The partial iris overlay may overlay/overlay partial iris deformities, etc.

The two cover implants 132 and 134 are assembled to each other by a sliding configuration. However, other alternative assembly configurations are contemplated.

Each covering implant includes a body having a frame 136 and a covering member 140, and the frame 136 has an attachment member 138 (fig. 16D) like the frame 12 in fig. 1-3. The cover member 140 has an opaque face (the upper surface is visible in plan view; the attachment members are on the opposite face of the frame) and may be entirely opaque.

Each of the cover members 140 and 142 has two portions:

the same body portion 144, which is the same as the mechanical portion 32 in fig. 4A;

a secondary portion having two laterally extending arms 148, 150 and 152, 154, both connected to the main portion 144.

The two arms of the two cover members are aligned with each other.

One of the two arms lies generally in a plane as the plane (planar configuration) of fig. 16A to 16C, while the other arm is in a raised position relative to the first arm and at an angle to the first arm.

Fig. 16D shows the angled projection arms 148 and 154 of two facing cover members that are mechanically engaged with each other to form an assembly.

This configuration may be such that each raised arm of a cover member overlaps to a lesser or greater extent a corresponding planar arm of another cover member (see fig. 16A-16C).

Each raised arm is provided with a protruding member 148a and 154a (fig. 16D), e.g. a lug, rib, etc. (fig. 16D), and each planar arm is provided with a longitudinal slot 150a and 152a (fig. 16A), wherein the protruding members are axially slidable (along axis X) so that the two cover members can move relative to each other as in fig. 16A-16C. Here, the protruding member extends downward from the lower surface of the arm.

The two arms of each cover member comprise a first zone Z1 corresponding to an opaque optical zone, which is intended to function as a diaphragm (which is an optical part having an optical face).

Both arms of each cover member also include second zones Z2 and Z2' corresponding to the opaque non-optical zones. Zones Z2 and Z2' have two spaced apart portions that are located to the sides of the first central zone Z1.

The above-mentioned sliding configuration is carried by the second zones Z2 and Z2', in particular by two spaced apart portions located laterally to the first central zone Z1.

In fig. 16A, circle C3 identifies a naturally dilated pupil having a central aperture O10. In this position, two zones Z1 extend over the hole O10, and zones Z2 and Z2' extend partially over the hole O10.

In fig. 16B and 16C, circles C4 and C5 identify increasingly constricted pupil positions, respectively. In these positions, the two zones Z1 extend above the reduced holes O11 and O12, respectively, and the zones Z2 and Z2' no longer overlap these holes. The two zones Z1 act as diaphragms particularly in the fully retracted position of fig. 16C. Zones Z2 and Z2' serve as artificial irises and cover a portion of the natural iris.

In this embodiment, body portion 144 and regions Z2, Z2' each have a transparent or opaque surface (colored, textured, and/or colored or uncolored) to cover the iris for local masking of distortion and the like and/or aesthetic reasons (color change and the like).

The region Z1 has an opaque optical surface (the entire region may be opaque) such as a black surface to function as a diaphragm when moved close to each other as shown in fig. 16C.

Fig. 17 shows the assembly 130 of fig. 16A-16D attached to the anterior surface of the iris I.

Other configurations are contemplated depending on the anatomy of the patient's eye and his/her optical condition. In particular, different shapes of iris covering implants, arms, etc. may be envisaged to cover more or less the natural iris.

Figure 18 shows another assembly 160 of several iris covering implants without optical diaphragm functionality. Component 160 represents an artificial iris implant that at least partially overlays a natural iris. Here, covering implants 162 and 164 have a U-shape similar to that of assembly 130, but any other shape may alternatively be employed. The two arms of each cover implant have a larger coverage area above the iris than the coverage area of assembly 130 to overlap the iris to a greater extent. Here, the optical area of the arm extending beyond the iris edge is removed. Both arms of each covering implant extend laterally relative to the body portion 144 of the covering member and rearwardly relative to the body portion 144 to meet the body portion 144 on either side. The shape of the arms may vary depending on the area of the iris of the assembly 130 that is to be covered, and may or may not cover the entire iris (some rules must be considered for placing the implant, as will be described later).

Here, the features and advantages of the assembly also apply to the assembly 160.

Fig. 19A to 19C show the implantation of a covering implant on the anterior surface of the iris I. This may apply to any of the above-described covering implants.

In fig. 19A, a set of several cover implants 170 is shown, the cover implants 170 being mounted on the iris around the pupil. Fig. 19A shows an upper view and a lower view: in the upper view, the iris is in an expanded position, and in the lower view, the iris is in a fully contracted position. The overall outer diameter of the iris (at its base) is called D, and C represents the radial displacement or travel of the iris between the two extreme positions. For example, the pupil diameter may be equal to 7mm in the dilated position and equal to 3mm in the fully contracted position, which results in a stroke C of 2 mm.

FIG. 19B shows the shape of a frustum of a cone with a base having an angle α, the base having a width L and a height h less than or equal to D-C.

This volume represents a typical volume V in which the covering implant(s) according to the invention can be installed, it being understood that a safety margin must be taken to avoid placing an implant that would touch or be too close to the iridocorneal angle (angle θ in fig. 19C).

Fig. 19C shows the space authorized to fit the implant on the iris (for simplicity, the iris is not shown here) given the size and shape of the cornea Cr.

The volume V is shown in an offset position (which does not correspond to any actual design) to highlight the width C that is not authorized for mounting the implant.

Generally, the angle α of the allowed volume is smaller than the angle θ, for example smaller than 60% of the angle, to avoid any contact between the implant(s) and the cornea Cr.

For the same reason, the length or width L is also preferably less than D-C.

For the same reasons as described above, the height h is less than the maximum axial distance A of the anterior chamber, and is, for example, less than 60% of this distance.

In other words, the constraints that must be considered before placing the covering implant on the iris depend on the actual diameter of the iris, the actual travel of the iris during its two extreme positions and the height of the cornea.

For example, for an average implant (i.e., an implant based on an average of biological data measurements obtained for multiple patients), the length or width L and height of the average implant should not exceed 7.5mm and 1.5mm for spatial physiological reasons. In any event, the size of the implant should be as small as possible.