Interdigitated ophthalmic implant with engagement protrusions

Abstract

The invention relates to a permanent intervening ophthalmic implant (20) between sclera and uveal tissue, characterized in that the implant (20) comprises a uveal compatible body (22) spatially having three dimensions, i.e. A length and a width and a thickness perpendicular to each other, the body of the implant comprising a first edge (24) and a second edge (26), the first edge is referred to as a leading edge to be oriented in a direction towards the anterior chamber of the eye to be in contact with the base of the ciliary muscle, and the second edge is referred to as a trailing edge opposite the leading edge (24) with respect to the body (22), the leading edge having at least one projection (32) towards the outside of the body (22) in a projection in a plane containing the width and the length, to allow at least one local contact of the at least one protrusion on the ciliary muscle base.

Description

Technical Field

[0001] The present invention relates to an interposition ophthalmic implant for collecting aqueous humor from the anterior chamber and delivering it to the supraciliary space and suprachoroidal space to provide a sustained reduction in intraocular pressure (IOP). Background Art

[0002] Intraocular pressure is the result of a balance between the production of aqueous humor secretion by the ciliary body and the flow of this secretion through the trabecular meshwork of the cornea and sclera and into the aqueous veins and general circulation via Schlemm's canal. Depending on age, 5% to 30% of this flow flows directly through the ciliary trabeculae between the sclera and ciliary body, which is the so-called uveo-scleral flow. The longitudinal fibers of the ciliary muscle, especially during adaptation, act to tension the trabecular meshwork and promote the uveo-scleral flow of aqueous humor. The uveo-scleral flow also flows through these longitudinal fibers of the ciliary muscle.

[0003] In glaucoma, the flow of aqueous humor across the corneal-scleral trabeculae is reduced, which in most cases leads to an increase in intraocular pressure (IOP). Therefore, lowering the IOP is a key factor in the medical and / or surgical treatment of glaucoma. Surgical treatment relies on two options: reducing the amount of aqueous humor produced by the ciliary body (weakening of the ciliary body) or increasing the flow of aqueous humor by diverting it. This diversion is performed in different ways:

[0004] - by making the anterior chamber communicate directly with the suprachoroidal space (cyclodialysis and its technical derivatives), but the effect obtained is usually temporary and insufficient. This implantation technique eliminates the physiological course of the uveo-scleral flow in the surgical area by stripping the ciliary muscle in the scleral process. In addition, postoperative fibrosis extends beyond this area. Moreover, it is known that the part of the implant located in the anterior chamber, even if it only intermittently affects the corneal endothelium, leads to a significant risk of developing corneal edema,

[0005] -Shortening of the trabecular obstruction by cutting the trabeculae starting from the anterior chamber all the way to Schlemm's canal. This intervention can be supplemented by inserting a stent into the canal that opens toward the anterior chamber to keep the aqueous humor permanently directed into the canal. Again, the results are often partial and temporary and do not exclude the need to continue or resume medical treatment.

[0006] Filtering surgery remains the treatment of choice and seeks to divert the aqueous humor beneath the conjunctiva to achieve the necessary pressure drop. It can create a full-thickness permanent hole in the trabeculae beneath a scleral flap: this is called a trabeculectomy. A variation also leaves the inner portion of the trabeculae in place, which is called non-penetrating trabecular surgery (deep sclerectomy, viscoelastic canalicularis).

[0007] However, filtration surgery has complications related to inadequate filtration due to fibrosis of the filtering bleb (a bulge between the sclera and conjunctiva) or, conversely, to excessive filtration, which may be related to the use of mitomycin C during surgery.

[0008] Furthermore, it is also known from the prior art that there have been many attempts to normalize IOP, thanks to implants, either used alone or in combination with the surgical procedures cited below. These implants now deform the anatomy of the eye and / or more or less divert / alter the natural flow channels. Furthermore, these implants are intended to match the dimensions of a standard eye; they do not accommodate anatomical variations that exist in nature.

[0009] In particular, it is known from document WO 2016 / 156727 A1 that when an intraocular implant is implanted, the hypotensive effect of the physiological uveo-scleral flow can be increased and permanently maintained by placing an implant that does not alter the anatomical structure between the sclera and the ciliary body, with or without additional filtration or other interventions.

[0010] The implant of document WO 2016 / 156727 A1 comprises a body including a front edge which is intended to be as close as possible to the trabecular uveal meshwork when the implant is located between the sclera and the ciliary body. The front edge is concave, forming an edge which allows the front edge to be in linear continuous contact with the ciliary muscle and its tendon at the ciliary muscle insertion into the scleral process. This geometry enables in particular close contact with the flow area of ​​the trabecular uveal meshwork.

[0011] A disadvantage of this type of interposition ophthalmic implant with linear continuous contact with the flow area of ​​the uveal trabeculae, similar to document WO 2016 / 156727 A1, is that the ophthalmic implant blocks some of the flow of aqueous humor due to the narrow contact between tissue and ophthalmic implant.

[0012] Another disadvantage of such ophthalmic implants is that they do not accommodate anatomical variations that may be encountered in patients. In particular, it has been observed that the anterior chamber diameter of a patient's eye can vary between 10.75 mm and 13.75 mm. Therefore, the performance of an ophthalmic implant may depend on the patient's anatomy.

[0013] Therefore, there is a need for an ophthalmic implant that does not have the above-mentioned disadvantages. In particular, there is a need for an ophthalmic implant that promotes the flow of aqueous humor from the trabecular uveal meshwork to a greater extent while maintaining correct anterior positioning and accommodating different anatomies of patients. Summary of the invention

[0014] To this end, the invention proposes an ophthalmic implant for permanent placement between the sclera and the uveal tissue, characterized in that the implant comprises a uveal compatible body consisting of a single part, the body having three dimensions in space, namely a length and a width perpendicular to each other, and a thickness, the body of the implant comprising a first edge (or anterior edge) and a second edge (or posterior edge), the first edge or anterior edge being oriented in the direction of the anterior chamber of the eye to contact the root of the ciliary muscle, and the second edge or posterior edge being opposite to the anterior edge relative to the body. Taking into account the desired position of the implant, the anterior edge of the implant may only contact the posterior wall of the root of the ciliary muscle. The anterior wall of the root of the ciliary muscle is located in the anterior chamber and constitutes one of its limits. The term "contacting the root of the ciliary muscle" as used herein must be understood as "contacting the posterior wall of the root of the ciliary muscle".

[0015] As seen in a projected view in a plane containing the width and the length, the leading edge has at least one protrusion oriented toward the outside of the body so that the at least one protrusion can have at least one local contact with the root of the ciliary muscle.

[0016] The geometry of the implant resulting in localized contact between the leading edge and the root of the ciliary muscle allows for the release of space between the implant body and the root of the ciliary muscle, thereby facilitating the release of aqueous humor from the uveal trabeculae and flow to the ciliary body and sclera.

[0017] Furthermore, the presence of partial contacts, either singly or in multiple locations, allows the front edge to be adapted to different patient anatomy. In fact, the implant is more easily positioned against the root of the ciliary muscle despite different anterior chamber diameters.

[0018] "Partial" contact means that only a portion of the leading edge will be in contact with the root of the ciliary muscle. Thus, the shape of the leading edge is such that it does not contact the root of the ciliary muscle over the entire leading edge.

[0019] In one embodiment of the implant, the leading edge comprises a plurality of protrusions oriented toward the exterior of the body, the protrusions collectively forming a discontinuous or partial contact edge at the root of the ciliary muscle.

[0020] In one embodiment of the implant, the contact edge defines a contact profile of the leading edge on the root of the ciliary muscle, the contact profile extending along a concave trajectory.

[0021] In one embodiment of the implant, the contact profile of the contact edge extends along at least one circular trajectory.

[0022] In one embodiment of the implant, the contact profile of the contact edge comprises at least one profile portion extending along a circular trajectory.

[0023] In one embodiment of the implant, the contact profile of the contact edge comprises at least two profile portions extending along circular trajectories with different radii of curvature.

[0024] In one embodiment of the implant, the contact profile of the contact edge includes at least one first profile portion extending along a first circular trajectory having a first radius of curvature and at least one second profile portion extending along a second circular trajectory having a second radius of curvature larger than the first radius of curvature, so that the contact edge can contact the root of the ciliary muscle having multiple possible anatomical radii.

[0025] In one embodiment of the implant, the first contour portion is formed at a central region of the contact edge and the second contour portion is arranged at a peripheral region of the contact edge.

[0026] In one embodiment of the implant, the second contour portion is arranged on either side of the first contour portion along the contact edge.

[0027] In one embodiment of the implant, at least one radius of curvature of the circular trajectory is greater than or equal to 4.5 mm and less than or equal to 6 mm.

[0028] In one embodiment of the implant, at least one radius of curvature of the circular trajectory is greater than 6 mm and less than or equal to 7.5 mm.

[0029] In one embodiment of the implant, the at least one protrusion is configured to allow at least one local contact on the root of the ciliary muscle.

[0030] In one embodiment of the implant, the at least one protrusion is configured to allow at least one linear contact on the root of the ciliary muscle.

[0031] In one embodiment of the implant, each protrusion comprises a contact edge portion, each of said contact edge portions extending along a concave trajectory.

[0032] In one embodiment of the implant, the thickness of the leading edge is reduced relative to the thickness of the body.

[0033] In one embodiment of the implant, the leading edge comprises an upper portion and a lower portion, the thickness of the leading edge decreasing at the upper portion.

[0034] In one embodiment of the implant, the body includes a locally reduced thickness portion located posteriorly from the leading edge and configured to elastically deform the leading edge by a force tending to press the leading edge against a supporting surface, such as the root of the ciliary muscle.

[0035] In one embodiment of the implant, the leading edge comprises at least one needle extending toward the outside of the body and protruding beyond the at least one protrusion in such a manner as to be able to penetrate the wall of the root of the ciliary muscle when the at least one protrusion is in contact with the root of the ciliary muscle.

[0036] In one embodiment of the implant, the needle includes a perforated distal point configured to penetrate the wall of the root of the ciliary muscle without previously forming an opening in said wall.

[0037] In one embodiment of the implant, the at least one needle comprises an aqueous humor collecting channel extending from an end of the at least one needle to the body of the implant.

[0038] In one embodiment of the implant, the body forms at least one aqueous humor collecting recess opening at the leading edge.

[0039] In one embodiment of the implant, the at least one recess is formed between two protrusions.

[0040] In one embodiment of the implant, the body of the implant is elastically deformable in a manner that enables it to be folded without permanent deformation in order to be manipulated by micro-instruments or injected using an ophthalmic injection system.

[0041] In one embodiment of the implant, the body of the implant is configured to have at least one radius of curvature of a circular trajectory greater than or equal to 4.5 mm and less than or equal to 6 mm when the implant is positioned in a deformed state corresponding to the placement of the body of the implant between the sclera and uveal tissue.

[0042] In one embodiment of the implant, the body of the implant is configured to have at least one radius of curvature of a circular trajectory greater than 6 mm and less than or equal to 7.5 mm when the implant is disposed in a deformed state corresponding to the placement of the body of the implant between the sclera and uveal tissue.

[0043] In one embodiment of the implant, the body of the implant has a concave curvature in a deformed state in a direction perpendicular to a plane defined by two dimensions of the implant perpendicular to its thickness, in which deformed state the implant can be used as an interposition ophthalmic implant between sclera and uveal tissue.

[0044] In one embodiment of the implant, the body of the implant is composed of a Young's modulus of 30 kg / cm 2 and 60kg / cm 2 Between or 30,000kg / cm 2 and 2,500,000kg / cm 2 Made of materials in between.

[0045] In one embodiment of the implant, the body of the implant is not elastically deformable and has a permanent curvature in a direction perpendicular to a plane defined by two dimensions of the implant perpendicular to the thickness.

[0046] In one embodiment of the implant, the body of the implant comprises at least one material selected from the group consisting of PTFE, polysilicone, and hydrophilic or hydrophobic acrylate hydrogel.

[0047] In one embodiment of the implant, the body of the implant has two opposing large surfaces separated from each other by the thickness of the body.

[0048] In one embodiment of the implant, the two opposing large surfaces include an upper surface and a lower surface separated by a thickness, and the body of the implant has one of the following configurations in a direction perpendicular to a plane defined by two dimensions of the implant perpendicular to the thickness:

[0049] - the upper surface is flat and the lower surface is concave,

[0050] - the upper surface is flat and the lower surface is convex,

[0051] - the upper and lower surfaces are convex,

[0052] - The upper and lower surfaces are planar.

[0053] In one embodiment of the implant, the main body is hollow and forms a central cavity between the upper surface and the lower surface. The central cavity can be open to the outside, for example, open to the outside at one or more places of the side edge and the trailing edge. This central cavity does not have material wholly or in part, particularly on the front and rear distance.

[0054] In one embodiment of the implant, the main body is formed by a plate folded on itself, the plate being folded in a manner that forms a central cavity between at least two opposing portions of the plate. Therefore, the main body can be formed by a mainly two-dimensional element (here a plate), the arrangement of which (here by folding) can form a three-dimensional main body, the thickness of which is greater than the combined thickness of the two facing portions of the plate.

[0055] In one embodiment of the implant, the body of the implant comprises at least one material selected from the following materials: polypropylene, plexiglass, titanium, stainless steel, nitinol.

[0056] In one embodiment of the implant, the body of the implant is penetrated by holes through its thickness and / or the body of the implant includes a relief on at least one of its two opposing large surfaces, which relief is suitable for promoting the flow of aqueous humor through the at least one large surface.

[0057] In one embodiment of the implant, the relief portion on the at least one large surface of the body is in the form of a recess formed on the at least one large surface, or in the form of roughness on the at least one large surface.

[0058] In one embodiment of the implant, the thickness (e) of the body of the implant is between 50 μm and 1000 μm.

[0059] In one embodiment of the implant, the body of the implant has the property of releasing one or more substances.

[0060] In one embodiment of the implant, the distance between the trailing edge and the leading edge is less than 1.0 mm.

[0061] The present invention may optionally be directed to a first method of inserting a permanent interposition ophthalmic implant between sclera and uveal tissue, wherein the implant may conform to the above-described implant, the method being performed after conventional intraocular surgical intervention has been performed on the patient's eye and one or more scleral flaps have been cut in the patient's eye, the method comprising the steps of:

[0062] - Raising one or more scleral flaps;

[0063] - making at least one incision, said incision extending to the ciliary body;

[0064] - Inserting the implant between the sclera and ciliary body;

[0065] - Positioning the implant as close as possible to the trabeculae so that the at least one protrusion is in contact with the root of the ciliary muscle.

[0066] The present invention may optionally involve a second method of inserting a permanent interposition ophthalmic implant between sclera and uveal tissue, wherein the implant may conform to the above-described implant, the method comprising the steps of:

[0067] - making at least one incision, said incision extending to the ciliary body;

[0068] - inserting the implant between the sclera and the ciliary body through the at least one incision;

[0069] - Positioning the implant as close as possible to the trabeculae so that the at least one protrusion is in contact with the root of the ciliary muscle.

[0070] In one embodiment of the first or second insertion method, the at least one incision is concentric with respect to the limbus.

[0071] In one embodiment of the first or second insertion method, the at least one incision is perpendicular relative to the limbus.

[0072] In one embodiment of the first or second insertion method, the leading edge includes at least one needle, the method includes creating at least one opening between the anterior chamber and the supraciliary space, and the step of positioning the implant includes inserting the at least one needle into the at least one opening between the anterior chamber and the supraciliary space until the at least one protrusion contacts the root of the ciliary muscle.

[0073] In one embodiment of the first or second insertion method, the number of openings formed between the anterior chamber and the supraciliary space is at least equal to the number of perforating needles of the leading edge.

[0074] In one embodiment of the first or second insertion method, the leading edge includes at least one needle having a perforated distal point, and the step of positioning the implant includes perforating the root of the ciliary muscle through the perforated distal point until the at least one protrusion contacts the root of the ciliary muscle.

[0075] In one embodiment of the first or second insertion method, the second insertion method further comprises, prior to inserting the implant, injecting a viscoelastic substance between the sclera and the ciliary body through the at least one incision to separate the two tissues. BRIEF DESCRIPTION OF THE DRAWINGS

[0076] The accompanying drawings describe the invention:

[0077] [ Figure 1 ] shows a highly schematic overview view showing a possible embodiment of an implant according to the invention from the front, which is positioned around the cornea of ​​an eye.

[0078] [ Figure 2 ] shows a detailed view of the leading edge of an implant according to the present invention, the implant comprising a plurality of protrusions capable of contacting the roots of the ciliary muscles of the eye.

[0079] [ Figure 3 ] shows a detailed view of the leading edge of an implant according to the invention, the implant comprising a plurality of protrusions forming contact edge portions extending along a circular trajectory having different radii of curvature.

[0080] [ Figure 4 ] shows a side view of an implant according to the present invention, wherein the leading edge is thinner than the body of the implant.

[0081] [ Figure 5 ] shows a side view of an implant according to the present invention, wherein the leading edge is thinner than the main body of the implant, and the leading edge also forms a local thinning portion on the lower surface or the upper surface of the implant.

[0082] [ Figure 6 ] shows a first embodiment of the leading edge of an implant according to the invention comprising a protrusion.

[0083] [ Figure 7 ] shows a second embodiment of the leading edge of an implant according to the invention comprising a protrusion.

[0084] [ Figure 8 ] shows a third embodiment of the leading edge of an implant according to the invention comprising two protrusions.

[0085] [ Fig. 9 ] shows a fourth embodiment of the leading edge of an implant according to the invention comprising two protrusions.

[0086] [ Fig.10 ] shows a fifth embodiment of the leading edge of an implant according to the invention comprising two protrusions.

[0087] [ Fig.11 ] shows a sixth embodiment of the leading edge of an implant according to the invention comprising two protrusions.

[0088] [ Fig.12 ] shows a seventh embodiment of the leading edge of an implant according to the invention comprising two protrusions.

[0089] [ Fig.13 ] shows an eighth embodiment of the leading edge of an implant according to the invention comprising two protrusions.

[0090] [ Fig.14 ] shows a ninth embodiment of the leading edge of an implant according to the invention comprising two protrusions forming contact edge portions extending along circular trajectories having different radii of curvature.

[0091] [ Fig.15 ] A first method of inserting an implant is shown highly schematically.

[0092] [ Fig.16 ] A second method of inserting an implant is shown highly schematically.

[0093] [ Fig.17 ] A schematic diagram showing a possible simplified overall shape of an implant according to the invention, the position of which in the human eye is shown, the implant being arranged between the sclera and the ciliary body.

[0094] [ Fig.18 ] shows that there is no Fig.17 A more detailed view of the structure of the iridocorneal angle on a larger scale, with the implant.

[0095] [ Fig.19 ] shows a top view of an implant comprising a plurality of protrusions and a first embodiment of a needle intended to be inserted into the anterior chamber of an eye.

[0096] [ Fig. 20] shows an implant of a second embodiment including a needle.

[0097] [ Fig.21 ] shows an implant of a third embodiment including a needle.

[0098] [ Fig. 22 ] shows an implant of a fourth embodiment including a needle.

[0099] [ Fig.23 ] shows a side view of the implant where the needle is thinner than the body of the implant.

[0100] [ Fig.24 ] shows a top view of the implant, in which the width of the needle decreases from the proximal end connected to the body to the distal end to facilitate insertion of the needle into the anterior chamber of the eye.

[0101] [ Fig.25 ] shows a side view of the implant, where the thickness of the needle is greater than the thickness of the implant body.

[0102] [ Fig.26 ] shows an implant comprising two needles intended to be inserted into the anterior chamber of the eye.

[0103] [ Fig. 27 ]The installation of an implant by a third method is shown in a highly schematic manner.

[0104] [ Fig.28 ] shows a side view of a needle having a perforating distal point having a beveled edge capable of perforating tissue at the root of the ciliary muscle.

[0105] [ Fig.29 ] shows a perspective view of a first example of a hollow implant having upper and lower surfaces separated by a central cavity.

[0106] [ Fig.30 ] shows a perspective view of a second example of a hollow implant having upper and lower surfaces separated by a central cavity.

[0107] [ Fig.31 ] shows Fig.30 Side view of the implant.

[0108] [ Fig.32 ] shows a third example of a hollow implant having upper and lower surfaces separated by a central cavity and comprising a needle with a beveled perforated distal point.

[0109] [ Fig.33 ] shows Fig.32 Side view of the implant. DETAILED DESCRIPTION

[0110] The concept of the present invention will be described more fully below with reference to the accompanying drawings, in which embodiments of the concept of the present invention are shown. In the accompanying drawings, the size and relative size of the elements may be exaggerated for clarity. In all the accompanying drawings, similar numbers represent similar elements. However, this concept of the present invention can be simplified to practice in a variety of different forms and should not be interpreted as being limited to the embodiments disclosed herein. On the contrary, these embodiments are proposed to make this description complete and to convey the scope of the concept of the present invention to those skilled in the art.

[0111] Reference to "embodiment" throughout the specification means that their specific functions, structures or features described with reference to one embodiment are included in at least one embodiment of the present invention. Therefore, the expression "in one embodiment" appearing in various places throughout the specification does not necessarily refer to the same embodiment. In addition, in one or more embodiments, specific functions, structures or features can be combined in any appropriate manner. In addition, the term "comprising" does not exclude other elements or steps.

[0112] The invention is described with the aid of the accompanying drawing, which shows an interposition ophthalmic implant intended to collect aqueous humor from the anterior chamber into the suprachoroidal space in order to continuously reduce the intraocular pressure (IOP).

[0113] For reasons of clarity in the present disclosure, the term "implant" may be used hereinafter to refer to an interposition ophthalmic implant.

[0114] The implant comprises a uveal compatible body, i.e. made of at least one material known for its uveal compatibility. This property confers on the body a very low adhesion to ocular tissues. In other words, the at least one material is not susceptible to degradation of superjacent and underlying structures after the body is in contact with these structures and repeatedly moves over time.

[0115] The body of the implant has three dimensions in space: thickness and length and width perpendicular to the thickness. The ratio between length and width can be less than, equal to, or greater than 1. For example, the dimensions (width, length, thickness) of the implant may be 4*5*0.1 mm, or 3*7*0.8 mm, or 6*3*0.6 mm. In addition, the thickness of the implant may vary between the leading edge and the trailing edge, for example, between 0.15 mm at the leading edge and 0.7 mm at the trailing edge. This variation may be gradual, random, throughout the anterior-posterior range, and / or localized.

[0116] The implant is preferably made in one part, in the sense that it is formed as an integral single piece. Therefore, the implant is not an assembly of a plurality of parts that are fixed to each other to form a main body.

[0117] The body of the implant is preferably thin so that, once placed between the sclera and uveal tissue, it does not unacceptably deform the overlying and underlying tissues. An acceptable deformation of the tissue is one that does not reduce the function of one and / or the other of these tissues. The thickness of the body 22 of the implant 20 is preferably between 50 μm and 1000 μm.

[0118] The main body of the implant includes two opposite edges, which are spaced a certain distance from each other in one of two directions perpendicular to the thickness. The two opposite edges include a front edge and a rear edge opposite to the front edge relative to the main body.

[0119] The leading edge will be toward or facing the anterior chamber of the eye and will come into contact with the posterior wall at the root of the ciliary muscle.

[0120] exist Figure 1 In FIG. 1 , the eye 10 is shown highly schematically from the front by the cornea 12, the pupil 14 in the center and the root 118 of the ciliary muscle. When the root 118 of the ciliary muscle is mentioned in this context, this means the posterior wall of the root of the ciliary muscle.

[0121] Implant 20 includes a body 22 having a leading edge 24 and a trailing edge 26. Side edges 28 and 30 extend between leading edge 24 and trailing edge 26 to either side of the body. Figure 1 The geometry of the implant is schematically shown. Figure 1 The purpose of the implant 20 is to determine the position of the implant 20 relative to the root 118 of the ciliary muscle and to identify the leading edge 24, the trailing edge 26, and the lateral edges 28, 30. The geometric features of the implant 20 will be described in detail below.

[0122] The trailing edge 26 is preferably convex. A convex edge describes a curve away from the body 22 of the implant 20, or conversely, a concave edge describes a curve concave or approaching the body 22 of the implant 20. Alternatively, the trailing edge 26 can be straight or concave.

[0123] In one possible embodiment, the convex portion of the trailing edge 26 is extended by the side edges 28 , 30 , ie no angle is formed between the side edges 28 and 30 and the trailing edge 26 .

[0124] Generally speaking, no matter how the shape of the implant is, the trailing edge 26 must be far enough from the leading edge to obtain an effective isolation effect. In practice, the trailing edge is preferably at least 1.0 mm away from the leading edge.

[0125] Generally speaking, regardless of the shape of the implant, the length of the trailing edge 26 is no more than 50% of the length of the leading edge.

[0126] The side edges 28 , 30 are symmetrical relative to one another, but in a variant not shown, they may be asymmetrical relative to one another.

[0127] The side edges 28, 30 may be arranged in a radial manner (side edges converge at an imaginary point located forward of the leading edge), in an extended manner (side edges converge at an imaginary point located forward of the trailing edge), or parallel to each other.

[0128] The body 22 of the implant 20 has two opposing large surfaces that are separated from each other by the thickness of the body 22. The two opposing large surfaces include an upper surface and a lower surface separated by the thickness. The upper surface is intended to contact the sclera. The lower surface is intended to contact the ciliary body.

[0129] The body 22 of the implant 20 may have any of the following shapes in a direction perpendicular to the plane defined by the two dimensions of the implant (the two dimensions being perpendicular to the thickness):

[0130] - the upper surface is flat and the lower surface is concave,

[0131] - the upper surface is flat and the lower surface is convex,

[0132] - the upper and lower surfaces are convex,

[0133] - The upper and lower surfaces are planar.

[0134] In one embodiment, body 22 can be hollow.Therefore, body 22 can form a central cavity between upper surface and lower surface.The central cavity can be open to the outside of the implant, for example, open to the outside at one or more places of lateral edge and trailing edge.This central cavity does not have material completely or partially, particularly does not have material along front and back distance.

[0135] In one embodiment of the implant, the main body is formed by a self-folded plate, and the plate is folded in a mode that forms a central cavity between at least two opposing parts of the plate. Therefore, the main body can be formed by a mainly two-dimensional element (plate here), which can be arranged (by folding here) into a three-dimensional body, and the thickness of this main body is greater than the combined thickness of two opposing parts of the panel. Some or all of the walls of the implant 20, i.e., the upper surface and the lower surface, the side edge and the leading edge and the trailing edge can be perforated. In other words, these walls can be produced in the form of mesh, so that the alternation of material and hole occurs.

[0136] Such mesh can be obtained by removing material or braiding material filaments. Implant 20 can be produced in the form of multiple braided mainly two-dimensional walls, forming a three-dimensional envelope surrounding the central cavity. This embodiment using perforated wall can facilitate the collection and flow of aqueous humor. Implant 20 can include a combination of perforated wall and solid wall.

[0137] The leading edge 24 includes at least one protrusion 32 toward the exterior of the body 22. Figure 1As shown in FIG. 1 , as seen in a projection view in a plane containing the width and the length, the at least one protrusion 32 protrudes from the body 20. The protrusion 32 allows at least one local contact of the at least one protrusion on the root of the ciliary muscle.

[0138] "Partial" contact means that only a portion of the leading edge 24 is intended to contact the root of the ciliary muscle. Therefore, the shape of the leading edge 24 is not in contact with the root of the ciliary muscle over the entire leading edge 24.

[0139] The leading edge 24 may include a single protrusion 32 of material to simplify the geometry of the leading edge 24 while maximizing the collection of aqueous humor. The protrusion 32 is preferably disposed at a central portion of the leading edge 24 to allow the implant 20 to be better positioned at the root of the ciliary muscle.

[0140] Reference Figure 2 The leading edge 24 includes a contact edge 36 that forms a contact area between the leading edge 24 and the root 118 of the ciliary muscle. Each protrusion 32 of the at least one protrusion 32 includes a contact edge portion 38 located at the distal end 40. If the leading edge includes a plurality of protrusions 32, the contact edge 36 is formed by a plurality of contact edge portions 38 carried by the protrusion 32.

[0141] In the case of a plurality of protrusions 32, the plurality of protrusions 32 collectively form a discontinuous or partial contact edge 36. In other words, the contact between the leading edge 24 and the root of the ciliary muscle is discontinuous because it is formed by a plurality of contact edge portions 38. In addition, the contact may be partial because it is not achieved by the entire leading edge 24, but only by a portion of the leading edge 24. The contact edge 36 preferably enables discontinuous and partial contact because the contact is achieved over a plurality of partial contact areas.

[0142] Increasing the number of contact edge portions 38 can improve the positioning and stability of the implant 20 relative to the root 118 of the ciliary muscle, which improves the collection of aqueous humor.

[0143] The at least one protrusion 32 may be configured to achieve at least one local contact on the root of the ciliary muscle. It should be noted that the tissue of the ciliary muscle is flexible and the concept of local contact is still theoretical. By deformation, the tissue will make contact on the contact area around this theoretical contact point. Therefore, "local" contact refers to a local contact area located at a portion of the protrusion 32 having a curved or convex profile. Therefore, the contact edge portion 38 of the at least one protrusion 32 may have a convex profile, thereby allowing theoretical local contact with a spherical surface such as the root of the ciliary muscle.

[0144] The convex profile of the contact edge portion 38 may be produced by a curved edge or by a plurality of straight edges along a curved profile.

[0145] The at least one protrusion 32 may be configured to allow at least one linear contact on the root 118 of the ciliary muscle. Thus, the contact edge portion 38 of the at least one protrusion 32 may have a straight or concave profile, thereby allowing linear contact with a spherical surface such as the root of the ciliary muscle.

[0146] The concave profile of the contact edge portion 38 may be produced by a curved edge or by a plurality of straight edges along a curved profile.

[0147] The at least one protrusion 32 extends along a longitudinal axis A passing through the contact edge portion 38 .

[0148] The at least one protrusion 32 forms a protrusion or step relative to the body 22, thereby allowing local contact with a convex surface. The protrusion or step is preferably separated from the rest of the body 22 by a distance at least equal to 0.05 mm. The step value or longitudinal dimension L is measured along the longitudinal axis A between the distal end 40 and the proximal end 42 of the at least one protrusion 32.

[0149] The at least one protrusion 32 may be elongated in shape. As shown in a projection view in a plane containing width and length, the at least one protrusion 32 has a transverse dimension T at its proximal end 42 in a direction perpendicular to the longitudinal axis A, which is smaller than its longitudinal dimension L.

[0150] Alternatively, the at least one protrusion 32 may be of flat shape, ie having a transverse dimension T at its proximal end 42 in a direction perpendicular to the longitudinal axis A that is greater than its longitudinal dimension L, as shown by projection in a plane containing the width and the length.

[0151] The sidewall of the at least one protrusion 32 may be straight, curved, or a combination of straight and curved walls.

[0152] The at least one protrusion 32 may also include a variation in width, i.e. a variation in the transverse dimension T, or have a geometry that enables the at least one protrusion 32 to deform elastically, i.e. without permanent deformation, along its longitudinal axis A. In particular, such a geometry that facilitates longitudinal elastic deformation may be S-shaped or spring-shaped.

[0153] More generally, the contact edge 36 defines a contact profile 44 of the leading edge on the root of the ciliary muscle. When the leading edge 24 includes a plurality of protrusions 32, each contact edge portion 38 extends along the contact profile 44.

[0154] The contact profile 44 preferably extends along a concave trajectory to improve contact between the leading edge 24 and the convex surface that delineates the root of the ciliary muscle. The concave side of the trajectory of the contact profile 44 is considered to be facing the implant 20. Thus, the concave trajectory means that the concave edge 36 extending along the profile delineates a concave contact edge that can best accommodate a convex surface, such as the root of the ciliary muscle.

[0155] The contact contour 44 can extend in particular along a circular trajectory in order to facilitate the manufacture of the implant, in particular when the implant is made by machining.Thus, each contact edge portion 38 extends along a portion of this circular trajectory.

[0156] The contact profile 44 may also extend along different trajectories. To this end, the contact profile 44 comprises a plurality of contact profile portions 46 which together form the contact profile 44. The contact profile portions 46 may be carried by one or more contact edge portions 38, ie the protrusions 32.

[0157] In order to obtain a good compromise between positioning the implant 20 and improving the collection of aqueous humor, groups (e.g., pairs) of protrusions 32 extending along the same trajectory can be formed. Thus, the leading edge 24 can include a first group of protrusions 32 extending along a first trajectory and a second group of protrusions extending along a second trajectory, the first trajectory being able to best adapt to the geometry of the first ciliary muscle, while the second trajectory being able to best adapt to the geometry of the second ciliary muscle. These groups or pairs of protrusions 32 are preferably distributed along the leading edge 24 to improve the stability of contact with the root of the ciliary muscle.

[0158] These contact profile portions 46 can extend in particular along different trajectories to obtain a geometry of the leading edge 24 that can adapt to a variety of surface shapes. Thus, one or more contact profile portions 46 can extend along a first trajectory, and one or more contact profile portions 46 can extend along a second trajectory. The trajectories can be different shapes, be in different positions, have different orientations or a combination of the above-mentioned different attributes. Thus, the contact profile 44 can extend continuously along a straight line and / or a concave trajectory.

[0159] The contact contour 44 can in particular extend along at least one circular trajectory. Thus, the contact contour 44 can extend along a plurality of circular trajectories. In other words, the contact edge portion 38 of the protrusion 32 can extend along different circular trajectories.

[0160] In an advantageous embodiment, the contact profile 44 can extend along a circular trajectory with different radii of curvature. In other words, the contact edge portion 38 of the protrusion 32 can extend along a circle with different diameters. Thus, the configuration (particularly the shape and orientation) of the protrusion 32 can be adapted to convex surfaces with different radii. Thus, the leading edge 24 can be adapted to different anatomical structures, in particular to eyes with different anterior chamber diameters.

[0161] The centers of these circular trajectories are preferably located in the same direction transverse to the leading edge 24 as shown in a projected view in a plane containing the width and the length.

[0162] In an advantageous embodiment, the leading edge 24 includes a set of protrusions 32 extending along circular trajectories having different radii of curvature. In other words, the contact profile 44 of the contact edge 36 includes at least one first profile portion extending along a first circular trajectory having a first radius of curvature and at least one second profile portion extending along a second circular trajectory having a second radius of curvature greater than the first radius of curvature, so that the contact edge can contact the ciliary muscle roots having a plurality of possible anatomical radii.

[0163] The first contour portion is formed at the central area of ​​the contact edge, and the second contour portion is arranged at the peripheral area of ​​the contact edge. Therefore, when multiple contact edge portions and protrusions 32 extend along the second track, the second contour portion is arranged on either side of the first contour portion along the contact edge.

[0164] It has been determined that the diameter of the anterior chamber of the eye can vary between 10.75 mm and 13.75 mm. Therefore, at least one radius of curvature that causes the leading edge 24 to follow a circular trajectory is greater than or equal to 4.5 mm and less than or equal to 6 mm. Additionally or alternatively, at least one radius of curvature that causes the leading edge 24 to follow a circular trajectory is greater than 6 mm and less than or equal to 7.5 mm.

[0165] Thus, the leading edge 24 comprises at least one set of protrusions 32 extending along a circular trajectory having a radius of curvature greater than or equal to 4.5 mm and less than or equal to 6 mm and at least one set of protrusions 32 extending along a circular trajectory having a radius of curvature greater than 6 mm and less than or equal to 7.5 mm.

[0166] In a first configuration, the body 22 of the implant 20 is not elastically deformable and has a permanent curvature in a direction perpendicular to a plane defined by two dimensions perpendicular to the thickness of the implant 20. In this embodiment, the implant 20 is therefore not elastically deformable and can have one or more anatomical curvatures. In other words, the implant 20 can be inserted into its position against the root of the ciliary muscle without elastic deformation.

[0167] In the second configuration, the main body 22 of implant 20 is elastically deformable in this way, i.e. folded without permanent deformation, so as to use micro-instrument manipulation or use ophthalmic injection system injection. When this main body 22 is no longer subject to folding force, it returns to its original non-deformed (static) position. In this embodiment, implant 20 is therefore an elastically deformable implant, and can have one or more anatomical curvatures. In other words, the deformed state of implant 20 is only used for placement, thereby it is inserted into tissue.

[0168] In the third configuration, the body 22 of the implant 20 is elastically deformable in such a way that it is folded without permanent deformation so as to be manipulated using a micro-instrument or injected using an ophthalmic injection system. When such a body 22 is no longer subjected to folding forces, it remains in situ in a deformed state in a position corresponding to the anatomical space between the sclera and uveal tissue. In other words, the implant 20 will be placed against the root of the ciliary muscle in a deformed state to insert it into the tissue, and this is also the case during its use.

[0169] When located between the sclera and the uveal body, the body 22 of the implant 20 is configured to have a radius of curvature of at least one circular trajectory greater than or equal to 4.5 mm and less than or equal to 6 mm. Additionally or alternatively, the body 22 of the implant 20 is configured to have a radius of curvature of at least one circular trajectory greater than 6 mm and less than or equal to 7.5 mm. These ranges of radius of curvature values ​​relate to each of the three configurations described above. In the third configuration, these ranges relate to the body of the implant 20 when the implant 20 is in a deformed state and located between the sclera and the uveal body. Therefore, regardless of the configuration of the body 22, when the implant 20 is located between the sclera and the uveal body, the body of the implant 20 is adapted to the diversity of the anatomical structures of the patient's eye.

[0170] In a deformed state that can be used as an interposition ophthalmic implant between sclera and uveal tissue, the body 22 of the implant 20 has a curvature in a direction perpendicular to the plane defined by the two dimensions of the implant perpendicular to the thickness. The curvature is preferably concave to best adapt to the patient's anatomy.

[0171] The main body of the implant can be made of a material with a Young's modulus between 30 kg / cm and 60 kg / cm 2 In this case, the body of the implant may include at least one material selected from the following materials: PTFE, polysiloxane, hydrophilic or hydrophobic acrylate hydrogel.

[0172] Alternatively, the body of the implant may be made of a material having a Young's modulus of 30,000 kg / cm 2 and 2,500,000kg / cm 2In this case, the body of the implant may include at least one material selected from the group consisting of: polypropylene, polymethyl methacrylate, titanium, stainless steel, and nitinol.

[0173] The main body of the implant can have the characteristic of releasing one or more substances. Such substances are for example anti-infective substances and / or anti-inflammatory substances. Therefore, these substances can be antibiotic substances and / or cortisone substances or anti-cortisone substances.

[0174] The body 22 of the implant 20 may be completely or partially covered with one or more substances or have a carefully selected surface state so that cell growth of the surrounding tissue on the implant 20 is inhibited or limited by the one or more substances or surface states.

[0175] exist Figure 3 An embodiment of a leading edge 24 is depicted in FIG. 2 , which comprises a set of protrusions extending along a circular trajectory having different radii of curvature.

[0176] In this embodiment, the leading edge 24 includes three groups of protrusions 32: a first group of protrusions 32a, a second group of protrusions 32b, and a third group of protrusions 32c. Three circular trajectories are shown: a first trajectory 48a, a second trajectory 48b, and a third trajectory 48c. The radius of curvature of the trajectory increases from the first trajectory 48a to the third trajectory 48c. In other words, the radius of curvature of the third trajectory 48c is greater than the radius of curvature of the second trajectory 48b, and the radius of curvature of the second trajectory 48b is greater than the radius of curvature of the first trajectory 48a.

[0177] The contact edge portions 38 of the first set of protrusions 32a extend along a first trajectory 48a. The contact edge portions 38 of the second set of protrusions 32b extend along a second trajectory 48b. The contact edge portions 38 of the third set of protrusions 32c extend along a third trajectory 48c.

[0178] In this Figure 3 In the embodiment of the present invention, each group includes two protrusions 32. Generally speaking, each group of protrusions 32 may include at least one protrusion 32. In addition, the leading edge 24 may include multiple groups of protrusions 32, which extend along multiple circular trajectories with different radii of curvature. Therefore, a leading edge that can adapt to multiple or even unlimited different anatomical structures of the root of the ciliary muscle can be manufactured.

[0179] Reference Figure 4 , the thickness of the leading edge 24 may be reduced relative to the thickness of the main body 22. This reduction may also occur on the at least one protrusion 32.

[0180] This thinning of the leading edge 24 preferably occurs at the end of the leading edge 24, which reduces the area of ​​the leading edge 24 that bears against the root 118 of the ciliary muscle for a given thickness of the body 22. This frees up space between the root 118 of the ciliary muscle and the body 22 of the implant 20, thereby improving the collection and circulation of aqueous humor toward the implant body.

[0181] The leading edge 24 comprises an upper portion 50 and a lower portion 52. Thus, the thickness of the leading edge decreases at the upper portion 50. The contact edge 36 is carried by the lower portion 52 of the leading edge 24.

[0182] This thinning of the leading edge 24 preferably extends along the longitudinal axis A from the contact edge 36 toward the body 22 at a distance less than or equal to 1.5 mm.

[0183] The thinning is preferably achieved over the entire length of the leading edge 24. Alternatively, the thinning is produced only over a portion of the length of the leading edge 24.

[0184] Reference Figure 5 , the leading edge 24 may also include a localized thinning 54 of thickness. This localized thinning 54 is formed on the upper or lower surface of the implant 20. This localized thinning 54 is configured to facilitate elastic deformation of the leading edge 24, in particular of its distal portion, so that the contact area between the root 118 of the ciliary muscle and the leading edge 24 can be increased. In fact, due to the effect of the force pressing the implant 20 to the root of the ciliary muscle along the longitudinal axis A, the localized thinning 54 makes it possible to induce the distal portion of the leading edge 24 to rotate towards the localized thinning 54. This deformation of the leading edge 24 facilitates the contact between the leading edge 24 and the root 118 of the ciliary muscle.

[0185] The body of the implant may be penetrated by holes through its thickness. These holes are passages for aqueous humor to flow through the body 22 from one relatively large surface to another relatively large surface. The body may also be penetrated by other multiple holes located in other planes.

[0186] The body 22 of the implant 20 may include a vent on at least one of its two opposing large surfaces, the vent being capable of facilitating the flow of aqueous humor on the at least one large surface.

[0187] For example, the discharge portion may be in the form of a channel or groove on the opposite surface. The channel or groove may be formed on the surface or through the body 22. These channels or grooves are preferably arranged substantially parallel to the direction extending from the leading edge 24 of the body 22 to the trailing edge 26.

[0188] The relief portion may be in the form of a recess on the at least one large surface, or in the form of a roughness on the at least one large surface.

[0189] It should be noted that the body 22 of the implant 20 may be incorporated through holes, channels / grooves, and recesses.

[0190] Figures 6 to 14 An embodiment of the body 22 of the implant 20 and most importantly an embodiment of the leading edge 24 is shown.

[0191] Figure 6 and Figure 7 Embodiments with leading edges 24 of different geometries are shown, including a single protrusion 32 that allows localized contact. The localized contact area between the implant 20 and the root of the ciliary muscle is represented by dots in the figure. As described above, the localized contact area can be localized or linear.

[0192] exist Figure 6 In the embodiment of the present invention, the leading edge 24 includes a protrusion 32 formed by a curved central portion extending between two retaining arms 34. These retaining arms 34 guide the aqueous humor to promote its flow towards the body 22 of the implant, thereby improving the efficiency of aqueous humor collection.

[0193] More generally, the leading edge may include at least one retaining arm 34 that projects from the body 2 toward the outside thereof. These retaining arms 34 are configured not to come into contact with the root 118 of the ciliary muscle. The purpose of these retaining arms 34 is to guide the aqueous humor to promote its flow toward the body of the implant 22. The leading edge 24 preferably includes at least two retaining arms 34, which are arranged, for example, at the sides of the leading edge 24.

[0194] In a particular configuration, the protrusions 32 on the leading edge 24 may have a retaining arm function, particularly when the leading edge 24 includes at least two protrusions 32 .

[0195] A collecting recess or space 35 is formed between the protrusion 32 and the retaining arm 34 .

[0196] exist Figure 7 In the embodiment, the protrusion 32 is an elongated protrusion. The protrusion 32 also extends in the middle of the two holding arms 34. A collecting recess 35 is also formed between the holding arms 34 and the protrusion 32.

[0197] exist Figure 6 and 7 In one embodiment, the geometry of the leading edge 24 includes the retaining arm 34. Alternatively, the leading edge 24 may be free of the retaining arm 34.

[0198] Figures 8 to 11 An embodiment of a leading edge 24 having a different geometry is shown, including two protrusions 32, capable of making localized contact at two regions of the root 118 of the ciliary muscle. In these figures, the localized contact region between the implant 20 and the root 118 of the ciliary muscle is represented by a dot. As described above, the localized contact region can be localized or linear.

[0199] exist Figures 8 to 11 In the embodiment, two protrusions 32 are formed at the outer peripheral portion of the leading edge 24. In other words, the two protrusions 32 are formed at the side ends of the leading edge 24. A collecting recess 35 is formed between the two protrusions 32.

[0200] exist Figures 8 to 11 In all of these embodiments of the leading edge 24 of FIG. 1 , the contact profile 44 of the contact edge 36 extends along a concave trajectory.

[0201] exist Figure 8 , 9 In the embodiment of the present invention, the two protrusions are elongated protrusions. Here, the two protrusions 22 form arms for keeping the aqueous humor in the collecting recess 35.

[0202] Fig.10 The middle protrusions 32 are each formed by the straight line and the inclined portion of the leading edge 24. The straight line and the inclined portion intersect at the central portion of the leading edge 24 to form a collecting recess 35.

[0203] Fig.12 and 13 Embodiments are shown having leading edge 24 of different geometries, including multiple protrusions 32, capable of making localized contact at multiple regions of the ciliary muscle root 118. In these figures, the localized contact areas between implant 20 and ciliary muscle root 118 are represented by dots.

[0204] The contact contour 44 of the contact edge 36 is along Fig.12 and 13 The concave trajectory in extends.

[0205] exist Fig.12 and 13 In the embodiment, the protrusions 32 form contact edge portions 38, all of which are arranged on the same trajectory, in particular the same circular trajectory.

[0206] exist Fig.12 In the embodiment, the protrusion 32 forms a linear contact edge portion 38 in such a manner as to obtain a linear contact area with the root 118 of the ciliary muscle.

[0207] Collecting recesses 35 are formed between the protrusions 32. Collecting channels or grooves are formed between these collecting recesses 35 and the trailing edge 26. These collecting recesses 35 have a circular or pseudo-circular shape.

[0208] exist Fig.13 In the embodiment, the protrusion 32 forms a curved contact edge portion 38 in such a manner as to obtain a local contact area with the root 118 of the ciliary muscle.

[0209] The collecting hole is formed at the lateral end of the leading edge 24. Generally, the collecting hole may be formed along the leading edge 24. The collecting channel or groove extends from the leading edge 24 to the trailing edge 26 to allow the aqueous humor to flow.

[0210] Fig.14 An embodiment of the leading edge 24 is shown in which the contact profile 44 extends along a plurality of circular trajectories having different radii of curvature.

[0211] With Figure 3 In a similar way, Fig.14 The leading edge of the embodiment includes a plurality of groups of protrusions 32, wherein each contact edge portion 38 extends along a different trajectory. In particular, Fig.14 The embodiment comprises four pairs of protrusions 32 extending along four circular trajectories having different radii of curvature.

[0212] To increase the flow of aqueous humor, a channel can be created through the root of the ciliary muscle to establish a direct communication between the anterior chamber of the eye and its supraciliary space (cyclodialysis). The channel is obtained through an incision made during the implantation procedure. However, in the absence of additional precautions, this opening will quickly close due to natural healing. If a non-absorbable and non-deformable object is used to keep it open, the opening may become more permanent.

[0213] to this end, Fig.19 An embodiment of the invention is shown in which, as shown in a projected view in a plane containing width and length, the leading edge 24 comprises a local extension protruding from the body 20. This local extension 37, referred to as a needle, is different from the protrusion defined above because it extends beyond the contact contour 44 and will completely penetrate the root of the ciliary muscle to establish a continuous and durable opening between the anterior chamber and the supraciliary space.

[0214] Leading edge 24 may include one or more needles 37 .

[0215] The at least one needle 37 extends along a longitudinal axis A passing through a distal point 56 .

[0216] The at least one needle 37 may be elongated in shape. As shown in a projection view in a plane containing the width and the length, the transverse dimension B of the needle 37 in a direction perpendicular to the longitudinal axis A may be smaller than its longitudinal dimension H.

[0217] Alternatively, the at least one needle 37 may be flat in shape, ie, the transverse dimension B of the needle 37 in a direction perpendicular to the longitudinal axis A is greater than its longitudinal dimension H, as seen in a projection view in a plane containing the width and the length.

[0218] The side wall of the at least one needle 37 may be straight, curved, or a combination of straight and curved walls.

[0219] The at least one needle 37 may also include a variation in width, i.e. a variation in the transverse dimension B, or may include a variation in geometry, so as to facilitate the penetration of the at least one needle 37 through the ciliary muscle. Such geometry must be supplemented by a properly selected distal shape to prevent the needle from being withdrawn from the anterior chamber, in particular by widening its distal point 56 and / or thickening it relative to the base of the at least one needle.

[0220] It has been determined that the thickness of the root of the ciliary muscle varies from person to person between 200 and 500 microns. In a preferred embodiment of the invention, the longitudinal dimension H of the at least one needle 37 is between 0.2 mm and 2.5 mm (inclusive).

[0221] In another preferred embodiment, the transverse dimension B of the at least one needle 37 is between 0.2 mm and 2.5 mm (inclusive).

[0222] Reference Fig.23 The thickness of the distal end 56 of the at least one needle may be reduced relative to the thickness of the main body 22, thereby constituting an element that facilitates its penetration through the ciliary muscle.

[0223] Reference Fig.25 The thickness of the distal end 56 of the at least one needle may be increased relative to the thickness of the body 22, thereby constituting a device for preventing the at least one needle from being withdrawn from the anterior chamber.

[0224] The distal point 56 of the at least one needle 37 may include a thinning followed by a thickening to facilitate its penetration through the ciliary muscle and then prevent its withdrawal.

[0225] The thinning and thickening may be performed in a plane perpendicular to the thickness of the implant 20 and / or in a plane of the thickness of the implant 20 .

[0226] The at least one needle 37 may be pierced by a hole passing longitudinally therethrough, or may contain grooves or recesses. These holes, grooves or recesses enable the flow of aqueous humor through the ciliary muscle.

[0227] The at least one needle may be positioned on a side edge of the implant 20 or between two protrusions 32 .

[0228] The at least one needle 37 may have a perforation distal point 57 configured to penetrate the wall of the root of the ciliary muscle without pre-forming an opening in the wall. In this case, the needle 37 is self-perforating because it can be inserted into tissue without a pre-opening. The perforation capability of the perforation distal point 57 may be obtained by one or more bevels at the needle distal end, so that the perforation distal point 57 has a triangular or truncated triangular cross-section in a plane perpendicular to the thickness of the implant 20. Fig.28 An embodiment of a needle including a perforated distal point 57 is depicted.

[0229] Fig.19 An embodiment of an implant 20 comprising four protrusions 32 and a spike 37 having a longitudinal distance H greater than a transverse distance B is shown.

[0230] Fig. 22 An embodiment of an implant 20 is shown that includes four protrusions 32 and a needle 37 whose longitudinal distance H is less than the transverse distance B. The needle also includes an internal channel and a groove.

[0231] Fig.24 Embodiments of the at least one needle geometry that can facilitate insertion through the ciliary muscle are shown.

[0232] exist Fig. 20 In the first embodiment, the distal point of the at least one needle 37 has a geometry that facilitates insertion through the ciliary muscle and prevents withdrawal.

[0233] exist Fig.21 In a second embodiment, the distal point of the at least one needle 37 has a geometry that facilitates insertion through the ciliary muscle and prevents withdrawal.

[0234] Fig.26 An implant 20 having two needles 37 and one protrusion 32 is shown.

[0235] Figures 29 to 33 An embodiment of an implant 20 in the form of a hollow body 22 is shown. Thus, a central cavity is formed between the upper and lower surfaces of the body 22. The upper and lower surfaces are connected to each other at one of the edges of the body 22, preferably at the front edge 24. The body 22 can be obtained by a self-folding plate. At the front edge 24, the junction between the upper and lower surfaces also forms at least one protrusion 32.

[0236] A needle 37 may also be formed on the leading edge 24. The needle 37 is also preferably hollow. The needle 37 comprises at least two walls, namely an upper wall and a lower wall.

[0237] Fig.15The implant 90 is shown implanted using a first implantation method according to one embodiment of the present invention. The implant 90 is intentionally shown in a simplified manner, but is consistent with the present invention as described above. The first method is used to supplement conventional anti-glaucoma surgical interventions or any intraocular intervention when it is necessary to reduce intraocular pressure. Trabeculectomies and sclerectomies require the removal of one or more scleral flaps of the eye, which will be lifted to continue the intervention. Scleral flap 92 (at Fig.15 The scleral flap (shown in dashed lines) is obtained by cutting the sclera in one or two planes and on three sides with variable depths: two substantially parallel incisions 92a, 92b extending from the cornea 12 and away from the cornea, and a third incision 92c perpendicular to the other two incisions and away from the cornea at a distance. The three incisions thus produced form one or more scleral flaps. After raising the one or more scleral flaps, two incisions ( Fig.15 94a, 94b), extending to the ciliary body, so that the implant can slide between the deep scleral plane and the ciliary body. The incisions are spaced at least 2mm apart from each other.

[0238] In a variation not shown, a single incision is made in the scleral plane to achieve the same purpose.

[0239] The implantation method used may then include a step of introducing a viscoelastic substance (e.g. of the hyaluronic acid type) through at least one incision made between the sclera and the ciliary body in order to separate these two tissues back to back in advance. This will allow the implant to be implanted without causing trauma to the superstructures and underlying structures.

[0240] This step is accomplished using an injection device, such as an injection cannula, having a diameter of approximately 20 g to 30 g.

[0241] Inject a small amount of material, such as 0.05mm 3 .

[0242] The surgeon forms the same number of openings between the anterior chamber and the supraciliary space as the number of needles 37 included in the implant 20. These openings are formed at the locations of the needles.

[0243] If the surgeon desires, a supplemental opening can be created between the anterior chamber and the supraciliary space.

[0244] The opening or openings can be produced by ab-interno or ab-externo, for example by mechanical action (scalpel, scraper, etc.) or laser. As for the supplementary opening, it can be performed during or after the operation.

[0245] The implantation method also includes the step of introducing an instrument (such as forceps) with a foam edge through one of the two incisions 94a, 94b, which extend to the ciliary body in the depth direction. The forceps are withdrawn through the incision, clamp the implant, and place it between the sclera and the ciliary body.

[0246] In a subsequent step using a microsurgical instrument (such as a spatula with a foam edge), as described above, implant 90 is positioned as close to the trabeculae as possible (in a manner concentric with the limbus) to collect the maximum amount of aqueous humor.

[0247] Another type of instrument or device, such as a syringe, may be used to enable the implant to be implanted and placed and positioned in the space between the sclera and ciliary body (the suprachoroidal space).

[0248] In another step, the scleral flap(s) are folded down and optionally sutured.

[0249] The first method described is also applicable to implanting a plurality of implants according to the present invention. In general, at least one different incision ( Fig.15 In some embodiments, even two) are used to implant each different implant.

[0250] Fig.16 An implant 100 is shown being implanted using a second implantation method according to an embodiment of the present invention. The implant 100 is shown in an intentionally simplified manner, but is consistent with the present invention as described above.

[0251] This approach is very similar to the first approach, except that the second approach does not supplement conventional interventions but may constitute an intervention in itself.

[0252] In this method:

[0253] - making two incisions 102a, 102b, which are preferably radial with respect to the cornea or preferably parallel to each other (eg Fig.15 The front end of the incision is located at 0 mm to 3 mm behind the corneal limbus (the transition zone between the cornea and the sclera), the incision length is, for example, 1 mm to 4 mm, and extends to the ciliary body.

[0254] - a viscoelastic substance, such as a hyaluronic acid type substance, can be injected through one of the two incisions,

[0255] - if necessary, according to the needs or intentions of the surgeon, creating an opening between the anterior chamber and the supraciliary space by the steps described in the first method,

[0256] - Lifting the sclera to allow insertion and positioning of the implant 100. The insertion steps are the same as those of the first method described above,

[0257] -The final step of suturing the incision is also optional.

[0258] In a variant embodiment not shown, in this second method a single incision is made and is sufficient to insert the implant between the sclera and the ciliary body.

[0259] Fig. 27 An implant 110 is shown implanted using a third implantation method according to an embodiment of the present invention. The implant 110 is shown in an intentionally simplified manner, but is consistent with the present invention as described above.

[0260] The second method is also applicable to implanting a plurality of implants according to the present invention. Generally speaking, in order to implant each different implant, at least one different incision (in Fig. 27 In some embodiments, there are even two).

[0261] This approach can complement conventional filtering surgery or be independent of any other intervention.

[0262] In this method, an incision 112 is made, preferably concentric with the limbus, between 1 mm and 5 mm from the limbus, over a distance of, for example, 0.5 mm to 4 mm.

[0263] Viscoelastic substances, such as hyaluronic acid type substances, can be injected through this incision.

[0264] The surgeon makes a number of openings between the anterior chamber and the supraciliary space equal to the number of needles 37 included in the implant 20. These openings are located at the locations of the needles. The surgeon may wish to make additional openings between the anterior chamber and the supraciliary space.

[0265] The opening or openings can be produced by ab-interno or ab-externo, for example by mechanical action (scalpel, scraper, etc.) or laser. As for the supplementary opening, it can be performed during or after the operation.

[0266] Then, with the help of forceps, the implant is inserted under the sclera along an axis perpendicular to the limbus, in the direction of the anterior chamber, until the protrusion of the implant contacts the root of the ciliary muscle 118. For implants 110 including one or more needles 37, this means that the needle passes through the opening made by the surgeon and then resides in the anterior chamber.

[0267] Another type of instrument or device may be used, such as a syringe that is capable of implanting, placing, and positioning the implant in the space between the sclera and ciliary body (the suprachoroidal space).

[0268] If the entire implant is not inserted beneath the sclera, the remaining posterior portion of the implant is tucked beneath the sclera in a direction away from the anterior chamber.

[0269] The final step of suturing the incision is also optional.

[0270] In the embodiment where the needle 37 includes a perforated distal point 57, the surgeon can omit making one or more incisions between the anterior chamber and the ciliary body space as described for the above three methods. In this case, the step of positioning the implant 20 at the root of the ciliary muscle includes perforating the root of the ciliary muscle with the perforated distal point 57 to insert the needle 37 into the anterior chamber until the at least one protrusion 32 contacts the root of the ciliary muscle.

[0271] It should be noted that Fig.15 , 16 The implants 90, 100 and 110 shown in and 27 can be any implants described above. The method of implanting the implant described above is applicable to any implant according to the present invention, in particular a permanent interposition ophthalmic implant between the sclera and the uveal tissue, which includes a thin uveal compatible body formed in one piece, the body of the implant including two opposite edges, which are spaced apart from each other in one of the two directions perpendicular to the thickness. The implant may also include any (or multiple, or even all) features described in the general description and various embodiments and variations.

[0272] The third method described is also applicable to implanting a plurality of implants according to the present invention. Generally speaking, at least one different incision is made for implanting each different implant.

[0273] Fig.17 An implant according to an embodiment of the invention is shown in cross section, which has been implanted using one of the methods described above.

[0274] This cross-section of a portion of an eye 110 illustrates an anterior chamber 112 , which is located between a cornea 114 and a lens 116 , the peripheral portion of which is bounded by an iris 119 .

[0275] The posterior chamber 120 is disposed behind the iris 119 .

[0276] The sclera 122 is connected to the periphery of the cornea 114 via the limbus 124 (the region of change in radius of curvature between the sclera and cornea). The sclera 122 covers the ciliary body 128, which is connected to the iris 119 and includes the ciliary muscle 130 on which the sclera 122 is carried.

[0277] The trabeculae 134 disposed between the cornea and the iris serve as a filter and allow aqueous humor circulating in the anterior chamber 112 to pass therethrough.

[0278] Schlemm's canal 136 is located between the sclera and cornea behind the trabeculae 134 .

[0279] The various arrows F1, F2, F3, and F4 depict the path or trajectory taken by the aqueous humor:

[0280] - F1 represents the normal path or flow taken by aqueous humor into the anterior chamber 112;

[0281] - F2 represents the diffusion path or flow of aqueous humor into the anterior chamber 112;

[0282] - F3 represents the normal path or flow of aqueous humor leaving the anterior chamber 112 through the trabeculae 134 and traveling toward Schlemm's canal 136;

[0283] - F4 represents the normal uveoscleral physiological flow of aqueous humor leaving the anterior chamber 112.

[0284] As described above, the implant 140 according to one embodiment of the present invention is disposed between the sclera 122 and the ciliary muscle 130. The implant is positioned as close as possible to the root 118 of the ciliary muscle (via its concave anterior edge) so as to exert its permanent spacing effect in the most appropriate position, taking into account the insertion of the ciliary muscle 130 in the scleral process. Fig.18 1 is a larger scale detailed view of the structure of the iridocorneal angle without an implant. As shown in this figure, the scleral process 132 into which the ciliary muscle 130 is inserted is located above the posterior portion 134a of the trabeculae 134.

[0285] The spacing created between the sclera and ciliary body at this location allows the aqueous humor to be permanently collected as close as possible to the area of ​​physiological uveo-scleral flow (the spacing effect creates an area of ​​low resistance to aqueous humor flow). Positioning the implant in this manner has resulted in a significant improvement in increasing physiological uveo-scleral flow.

[0286] like Fig.17 As shown by arrows F5 above and below the implant, the supplementary flow through the posterior part of the trabeculae (ciliary body trabeculae) partially increases the uveal-scleral physiological flow. However, this supplementary flow is obtained due to the spacing effect of the implant between the sclera and the ciliary body, and the implant is as close as possible to the root 118 of the ciliary muscle without damaging the root of the ciliary muscle.

Claims

1. A permanent interposition ophthalmic implant (20) between sclera and uveal tissue, characterized in that: The implant (20) comprises a uveal compatible body (22) having three dimensions in space, namely a length and a width perpendicular to each other and a thickness, the body of the implant comprising a first edge or leading edge (24) and a second edge or trailing edge (26), the first edge or leading edge (24) being oriented in a direction towards the anterior chamber of the eye to contact the root of the ciliary muscle, the second edge or trailing edge (26) being opposite to the leading edge (24) relative to the body (22), as shown in a projected view in a plane containing the width and the length, the leading edge having at least one protrusion (32) oriented towards the outside of the body (22) so that the at least one protrusion (32) has at least one local contact with the root (118) of the ciliary muscle.

2. The interposition ophthalmic implant (20) according to claim 1, wherein: The leading edge (24) includes a plurality of protrusions (32) oriented toward the exterior of the body (22), the protrusions collectively forming a discontinuous or localized contact edge (36) at the root (118) of the ciliary muscle.

3. The interposition ophthalmic implant (20) according to claim 2, wherein: The contact edge (36) defines a contact profile (44) of the leading edge (24) on the root (118) of the ciliary muscle, the contact profile (44) extending along a concave trajectory.

4. The interposition ophthalmic implant (20) according to claim 3, wherein: The contact contour (44) of the contact edge (36) extends along at least one circular trajectory (48a, 48b, 48c).

5. The interposition ophthalmic implant (20) according to claim 3 or 4, wherein: The contact profile (44) of the contact edge (36) comprises at least one profile portion (46) extending along a circular trajectory (48a, 48b, 48c).

6. The interposition ophthalmic implant (20) according to claim 5, wherein: The contact profile (44) of the contact edge (36) comprises at least two profile portions (46) extending along circular trajectories (48a, 48b, 48c) having different radii of curvature.

7. The interposition ophthalmic implant (20) according to claim 6, wherein: The contact profile (44) of the contact edge (36) includes at least one first profile portion extending along a first circular trajectory having a first radius of curvature and at least one second profile portion extending along a second circular trajectory having a second radius of curvature greater than the first radius of curvature, so that the contact edge (36) can contact the root of the ciliary muscle having a plurality of possible anatomical radii.

8. The interposition ophthalmic implant (20) according to claim 7, wherein: The first contour portion is formed at a central region of the contact edge, and the second contour portion is provided at a peripheral region of the contact edge.

9. The interposition ophthalmic implant (20) according to claim 7 or 8, wherein: The second profile portion is disposed along the contact edge (36) on either side of the first profile portion.

10. The interposition ophthalmic implant (20) according to any one of claims 4 to 9, wherein: At least one radius of curvature of the circular trajectory (48a, 48b, 48c) is greater than or equal to 4.5 mm and less than or equal to 6 mm.

11. The interposition ophthalmic implant (20) according to any one of claims 4 to 10, wherein: At least one radius of curvature of the circular trajectory (48a, 48b, 48c) is greater than 6 mm and less than or equal to 7.5 mm.

12. The interposition ophthalmic implant (20) according to any one of the preceding claims, wherein: The at least one protrusion (32) is configured to allow at least one localized contact at the root (118) of the ciliary muscle.

13. The interposition ophthalmic implant (20) according to any one of claims 1 to 11, wherein: The at least one protrusion (32) is configured to allow at least one linear contact on the root (118) of the ciliary muscle.

14. The interposition ophthalmic implant (20) according to claim 12 or 13 in combination with claim 3, wherein: Each protrusion (32) includes a contact edge portion (38), each of the contact edge portions (38) extending along a concave trajectory.

15. The interposition ophthalmic implant (20) according to any one of the preceding claims, wherein: The thickness of the leading edge (24) is reduced relative to the thickness of the main body (22).

16. The interposition ophthalmic implant (20) according to claim 15, wherein: The leading edge (22) includes an upper portion (50) and a lower portion (52), and the thickness of the leading edge (24) is reduced at the upper portion (50).

17. The ophthalmic implant (20) according to claim 15 or 16, wherein: The body includes a locally reduced thickness portion (54) located rearwardly from the leading edge (24), and the locally reduced thickness portion (54) is configured to elastically deform the leading edge (24) under the action of a force tending to press the leading edge (24) against a supporting surface, such as the root (118) of the ciliary muscle.

18. The interposition ophthalmic implant (20) according to any one of the preceding claims, wherein: The leading edge (24) includes at least one needle (37) extending toward the outside of the body (22) and protruding beyond the at least one protrusion (32) in such a manner that the needle (37) can penetrate the wall of the root (118) of the ciliary muscle when the at least one protrusion (32) contacts the root (118) of the ciliary muscle.

19. The interposition ophthalmic implant (20) according to claim 18, wherein: The needle (37) includes a perforation distal point (57) configured to penetrate the wall of the root (118) of the ciliary muscle without previously forming an opening in the wall.

20. The interposition ophthalmic implant (20) according to claim 18 or 19, wherein: The at least one needle (37) includes an aqueous humor collecting channel extending from one end of the at least one needle (37) to the body (22) of the implant.

21. The interposition ophthalmic implant (20) according to any one of the preceding claims, wherein: The body (22) forms at least one aqueous humor collecting recess opening at the leading edge (24).

22. The interposition ophthalmic implant (20) according to claim 21 in combination with claim 2, wherein: The at least one recess is formed between the two protrusions (32).

23. The interposition ophthalmic implant (20) according to any one of the preceding claims, wherein: The body (22) of the implant is elastically deformable in a manner that allows it to be folded without permanent deformation so as to be manipulated by micro-instruments or injected using an ophthalmic injection system.

24. The ophthalmic implant (20) according to claim 23 in combination with claim 10, wherein: When the implant is disposed in a deformed state corresponding to the arrangement of the body of the implant between the sclera and uveal tissue, the body (22) of the implant is configured to have at least one radius of curvature of a circular trajectory greater than or equal to 4.5 mm and less than or equal to 6 mm.

25. The ophthalmic implant (20) according to claim 23 in combination with claim 11, wherein: When the implant is disposed in the deformed state corresponding to the arrangement of the body of the implant between the sclera and uveal tissue, the body (22) of the implant is configured to have a radius of curvature of at least one circular trajectory greater than 6 mm and less than or equal to 7.5 mm.

26. The interposition ophthalmic implant (20) of claim 23, wherein: The body (22) of the implant has, in a deformed state, a concave curvature in a direction perpendicular to a plane defined by two dimensions of the implant perpendicular to the thickness, in which state the implant can be used as an interposition ophthalmic implant between sclera and uveal tissue.

27. The interposition ophthalmic implant (20) according to any one of the preceding claims, wherein: The main body (22) of the implant is composed of a Young's modulus of 30 kg / cm 2 and 60kg / cm 2 Between or above 30,000kg / cm 2 and 2,500,000kg / cm 2 Made of materials in between.

28. The interposition ophthalmic implant (20) according to any one of claims 1 to 21, wherein: The body (22) of the implant is not elastically deformable and has a permanent curvature in a direction perpendicular to a plane defined by two dimensions of the implant perpendicular to the thickness.

29. The interposition ophthalmic implant (20) according to any one of the preceding claims, wherein: The body (22) of the implant comprises at least one material selected from the group consisting of PTFE, polysiloxane, and hydrophilic or hydrophobic acrylate hydrogel.

30. The interposition ophthalmic implant (20) according to any one of the preceding claims, wherein: The body (22) of the implant has two opposing large surfaces separated from each other by the thickness of the body.

31. The interposition ophthalmic implant (20) of claim 30 in combination with claim 28, wherein: The two opposing large surfaces include an upper surface and a lower surface separated by a thickness, and the body of the implant has one of the following configurations in a direction perpendicular to a plane defined by two dimensions of the implant perpendicular to the thickness: - the upper surface is flat and the lower surface is concave, - the upper surface is flat and the lower surface is convex, - the upper and lower surfaces are convex, - The upper and lower surfaces are planar.

32. The interposition ophthalmic implant (20) according to claim 30 or 31, wherein: The body (22) of the implant is pierced by holes through its thickness and / or the body of the implant comprises a drainage portion on at least one of its two opposing large surfaces, which drainage portion is suitable for promoting the flow of aqueous humor through the at least one large surface.

33. The interposition ophthalmic implant (20) of claim 32, wherein: The relief portion on the at least one large surface of the body (22) is in the form of a recessed portion formed on the at least one large surface, or in the form of roughness on the at least one large surface.

34. The interposition ophthalmic implant (20) according to any one of the preceding claims, wherein: The body (22) of the implant has a thickness (e) between 50 μm and 1000 μm.

35. The interposition ophthalmic implant (20) according to any one of the preceding claims, wherein the body (22) of the implant has the property of releasing one or more substances.

36. The interposition ophthalmic implant (20) according to any one of the preceding claims, wherein: The distance between the trailing edge (26) and the leading edge (24) is less than 1.0 mm.

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