Ophthalmic implant with engaging protrusions - Patent application

Abstract

The present invention relates to an ophthalmic implant (20) for permanent interposition between the sclera and the uveal tissue, the implant (20) being characterized by a uveal compatible body (22) having three spatial dimensions, namely length, width and thickness, perpendicular to one another, the implant body having a first so-called anterior edge (24) intended to be in contact with the root of the ciliary muscle towards the anterior chamber of the eyeball and a second so-called posterior edge (26) opposite the anterior edge (24) with respect to the body (22), the anterior edge having at least one protrusion (32) directed towards the outside of the body (22) in order to allow at least local contact of said at least one protrusion with the root of the ciliary muscle, according to a projection in a plane including the width and the length.

Description

[Technical field]

[0001] The present invention relates to an ophthalmic implant that collects aqueous humor from the anterior chamber and directs it to the supraciliary and suprachoroidal spaces to sustainably reduce intraocular pressure (IOP). [Background technology]

[0002] Intraocular pressure is the result of a balance between the secretion of aqueous humor by the ciliary body, the flow of aqueous humor through the trabecular meshwork of the cornea via Schlemm's canal, and its drainage into the aqueous venules and the systemic circulation. A portion of this flow, which accounts for 5-30% depending on age, flows directly through the trabecular meshwork of the ciliary body between the sclera and the ciliary body, and is called the uveoscleral outflow. The longitudinal fibers of the ciliary muscle, especially during accommodation, tension the trabecular meshwork and facilitate the uveoscleral outflow of aqueous humor. The uveoscleral outflow of aqueous humor also occurs via the longitudinal fibers of the ciliary muscle. [Prior art documents] [Patent documents]

[0003] [Patent Document 1] International Patent Application Publication No. 2016 / 156727

[0004] In glaucoma, the outflow of aqueous humor from the trabecular meshwork of the cornea is reduced, often leading to an increase in intraocular pressure (IOP). Reducing this IOP is therefore a crucial factor in the medical and surgical treatment of glaucoma. Surgical treatment has two options: either to reduce the production of aqueous humor produced by the ciliary body (cyclowaking) or to increase it by diverting the flow of aqueous humor. This diversion can be achieved in various ways: - Direct communication between the anterior chamber and the suprachoroidal space (cyclodialysis and its derivatives) exists, but the results are usually transient and insufficient. By removing the insertion of the ciliary muscle at the scleral spur, this technique removes the physiological mechanism of uveoscleral outflow at the surgical site. Moreover, postoperative fibrosis can extend beyond this area. It is also known that parts of the graft tissue located in the anterior chamber may come into contact, even intermittently, with the corneal endothelium, leading to a significant risk of progressive corneal edema. - Dissection of the trabecular meshwork from the anterior chamber to Schlemm's canal to bypass the trabecular meshwork obstruction. This intervention is completed by placing a stent in the canal opening into the anterior chamber, allowing permanent direct access of the aqueous humor to the canal. This may be supplemented by the insertion of a stent into the canal, opening into the anterior chamber to allow direct and permanent access of aqueous humor from the anterior chamber to the canal. Again, results are often partial and temporary, and do not obviate the need for continuation or resumption of medical therapy.

[0005] Filtration surgery remains the most common treatment and aims to divert aqueous humor under the conjunctiva to achieve the required pressure reduction. Filtration surgery can create a permanent full-thickness hole in the trabecular meshwork under the scleral flap, known as non-penetrating trabeculectomy. There are also procedures that leave the interior of the trabecular meshwork intact, known as non-penetrating trabecular meshwork surgery (deep scleral incision, viscoelastic canalectomy). However, filtration surgery can result in complications related to filtration failure due to fibrosis of the filtering capsule (located between the sclera and the conjunctiva, where the conjunctiva is elevated) or, conversely, overfiltration, which may be related to the use of mitomycin C in the procedure.

[0006] Furthermore, many attempts to normalize intraocular pressure (IOP) using implants, either in combination with the abovementioned surgical procedures or alone, are known from the prior art. However, all these implants more or less deform the anatomical structure of the eye or bypass / modify the natural outflow pathways. Moreover, these implants are designed to fit standard eye dimensions and do not adapt to the anatomical variations present in nature.

[0007] In particular, Patent Document 1 discloses that implanting an intraocular lens between the sclera and the ciliary body increases and perpetuates the hypotensive effect of physiological uveoscleral outflow, with or without filtration or other intervention, without changing the anatomical structure.

[0008] The implant of the '693 patent includes a body with a leading edge intended to be located as close as possible to the trabecular meshwork when the implant is between the sclera and the ciliary body. This leading edge is concave and forms an edge that allows linear and continuous contact between the leading edge and the ciliary muscle and its tendon at the level of its insertion into the scleral spur. This shape allows in particular a close contact with the flow area of ​​the trabecular meshwork.

[0009] In ocular implants for insertion that make linear and continuous contact with the flow area of ​​the trabecular meshwork, such as that described in Patent Document 1, it has been found that the contact between the tissue and the ocular implant is narrow, resulting in the ocular implant blocking part of the flow of aqueous humor.

[0010] Another drawback of this type of ocular implant is that it does not accommodate possible anatomical variations that may occur in patients. In particular, it has been observed that the diameter of the anterior chamber of a patient varies between 10.75 mm and 13.75 mm. Thus, the performance of the ocular implant may depend on the patient's anatomy.

[0011] Therefore, there is a need for an ophthalmic implant that does not suffer from the above drawbacks, and in particular, an ophthalmic implant that better promotes aqueous humor flow from the trabecular meshwork while maintaining good anterior positioning and accommodating different patient anatomies.

[0012] The present invention therefore proposes an ophthalmic implant for permanent insertion between the sclera and the uveal tissue, comprising a uveal compatible body formed from a single piece, the body having three spatial dimensions, characterized in that the body of the implant comprises a first or anterior edge intended to be in contact with the root of the ciliary muscle towards the anterior chamber of the eyeball, and a second or posterior edge on the opposite side of the body to the anterior edge. Taking into account the required position of the implant, the anterior edge of the implant may only be in contact with 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 boundaries. The term "in contact with the root of the ciliary muscle" as used herein should be understood in the sense of "in contact with the posterior wall of the root of the ciliary muscle".

[0013] When viewed in a projection onto a plane including width and length, the leading edge has at least one projection protruding outwardly, said at least one projection being capable of locally contacting the root of the ciliary muscle.

[0014] The shape of the implant that creates local contact between the body of the implant and the root of the ciliary muscle creates a space between the body of the implant and the root of the ciliary muscle, facilitating the egress of aqueous humor from the trabecular meshwork and its flow toward the ciliary body and sclera.

[0015] Furthermore, local contacts, whether single or multiple, allow the leading edge to adapt to different patient anatomies, in fact facilitating the placement of the implant at the base of the ciliary muscle, even in cases with different anterior chamber diameters.

[0016] "Localized" contact means that only a portion of the leading edge contacts the root of the ciliary muscle. Thus, the leading edge is formed such that the entire leading edge does not contact the root of the ciliary muscle.

[0017] According to one embodiment of the implant, the leading edge comprises a plurality of projections projecting towards the outside of the body, said projections collectively forming a discontinuous or localized contact edge on the root of the ciliary muscle.

[0018] According to one embodiment of the implant, the contact edge defines a contact profile on the root of the ciliary muscle at the leading edge, which contact profile extends along a concave locus.

[0019] According to one embodiment of the implant, the contact profile of the contact edge extends along at least one circular orbit.

[0020] According to one embodiment of the implant, the contact profile of the contact edge comprises at least one profile section extending along a circular trajectory.

[0021] According to one embodiment of the implant, the contact profile of the contact edge comprises at least two profile parts extending along a circular path with different radii of curvature.

[0022] According to one embodiment of the implant, the contact profile of the contact edge comprises at least one first profile portion extending along a first circular orbit having a first radius of curvature and at least one second profile portion extending along a second circular orbit having a second radius of curvature greater than the first radius of curvature, enabling the contact edge to make iris contact with the root of the ciliary muscle having multiple anatomical radii.

[0023] According to one embodiment of the implant, the first profile portion is formed in a central region of the contact edge and the second profile portion is arranged in a peripheral region of the contact edge.

[0024] According to one embodiment of the implant, the second profile portions are arranged on either side of the first profile portion along a contact edge.

[0025] According to one embodiment of the implant, at least one radius of curvature of the circular orbit is ≧4.5 mm and ≦6 mm.

[0026] According to one embodiment of the implant, at least one radius of curvature of the circular orbit is greater than 6 mm and less than or equal to 7.5 mm.

[0027] According to one embodiment of the implant, the at least one protrusion is configured to enable at least one localized contact with the root of the ciliary muscle.

[0028] According to one embodiment of the implant, the at least one protrusion may be configured to enable at least one line contact with the root of the ciliary muscle.

[0029] According to one embodiment of the implant, each projection includes a contact edge that extends along a respective concave locus.

[0030] According to one embodiment of the implant, the thickness of the leading edge is reduced relative to the thickness of the body.

[0031] According to one embodiment of the implant, the leading edge has an upper portion and a lower portion, the leading edge having a thinner thickness at the upper portion.

[0032] According to one embodiment of the implant, the body has a locally reduced thickness posterior to the leading edge and is configured to allow the leading edge to undergo elastic deformation under the action of a force pressing the leading edge against a supporting surface (e.g. the root of the ciliary muscle).

[0033] According to one embodiment of the implant, the leading edge extends towards the outside of the body and comprises at least one needle that protrudes beyond the at least one protrusion so as to be able to pass through 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.

[0034] According to one embodiment of the implant, the needle comprises a piercing distal point configured to pierce the wall of the root of the ciliary muscle without preforming an opening in said wall.

[0035] According to one embodiment of the implant, at least one needle extends from one end of the at least one needle to the body of the implant.

[0036] According to one embodiment of the implant, the body defines at least one aqueous humor collecting recess that opens at the leading edge.

[0037] According to one embodiment of the implant, at least one recess is formed between two protrusions.

[0038] According to one embodiment of the implant, the body of the implant is elastically deformable such that it can be folded without permanent deformation in order to be manipulated with a microinstrument or injected using an ophthalmic injection system.

[0039] According to one embodiment of the implant, the body of the implant is configured such that when the body of the implant is positioned in a deformed state corresponding to a state in which the body of the implant is inserted between the sclera and the uveal tissue, at least one radius of curvature of the circular orbit is greater than or equal to 4.5 mm and less than or equal to 6 mm.

[0040] In one embodiment of the implant, the body of the implant is configured such that when the body of the implant is positioned in the deformed state, which corresponds to a state in which the body of the implant is inserted between the sclera and the uveal tissue, at least one radius of curvature of the circular orbit is greater than 6 mm and less than or equal to 7.5 mm.

[0041] In one embodiment of the implant, the body of the implant has a concave curvature in a direction perpendicular to a plane defined by two dimensions perpendicular to the thickness in a deformed state that allows it to be used as an ophthalmic implant for insertion between the sclera and uveal tissue.

[0042] In one embodiment of the implant, the body of the implant has a Young's modulus of 30 to 60 kg / cm 2 or 30,000~2,500,000kg / cm 2 It is made of materials.

[0043] In one embodiment of the implant, the body of the implant is not elastically deformable but has a permanent curvature in a direction perpendicular to a plane defined by the two dimensions perpendicular to the thickness.

[0044] In one embodiment of the implant, the body of the implant comprises at least one material selected from PTFE, polysiloxane, hydrophilic or hydrophobic acrylate hydrogels.

[0045] In one embodiment of the implant, the body of the implant has two opposing major faces separated from each other by the thickness of the body.

[0046] In one embodiment of the implant, the two opposing major surfaces comprise an upper surface and a lower surface separated by a thickness, and the body of the implant has, in a direction perpendicular to a plane defined by the two dimensions perpendicular to the thickness, one of the following shapes: - 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 top and bottom surfaces are flat.

[0047] In one embodiment of the implant, the body is hollow and forms a central cavity between the upper and lower surfaces. The central cavity may be open to the outside, for example at one or more of the lateral and posterior edges. This central cavity is free or partially free of material, particularly over an anterior-posterior distance.

[0048] In one embodiment of the implant, the body is formed by folding a plate so as to form a central cavity between at least two opposing portions of the plate. The body can therefore be formed by mainly two-dimensional elements, here plates, the arrangement, here folding, of which can form a three-dimensional body having a thickness greater than the combined thickness of the two opposing portions of the plate.

[0049] In one embodiment of the implant, the body of the implant comprises at least one material selected from polypropylene, plexiglass, titanium, stainless steel, and nitinol.

[0050] In one embodiment of the implant, the body of the implant is pierced by openings passing through its thickness and / or the body of the implant is provided on at least one of its two opposing major faces with a relief adapted to promote the flow of aqueous humor across said at least one major face.

[0051] In one embodiment of the implant, the relief on said at least one major surface takes the form of recesses formed or imparted roughness on said at least one major surface.

[0052] In one embodiment of the implant, the thickness (e) of the body of the implant is between 50 and 1000 μm.

[0053] In one embodiment of the implant, the body of the implant has the property of releasing one or more substances.

[0054] In one embodiment of the implant, the trailing edge is less than 1.0 mm from the leading edge.

[0055] The present invention may optionally relate to a first method of inserting an ocular implant for permanent insertion between the sclera and uveal tissue, where the implant may conform to the implants described above, the method being performed after conventional intraocular surgery has been performed on a patient's eye and one or more scleral flaps have been incised in the patient's eye, and comprising the following steps: - Lifting one or more scleral flaps. - Making at least one incision extending to the ciliary body. - The implant is inserted between the sclera and the ciliary body. - positioning the implant as close as possible to the trabecular meshwork so that said at least one protrusion contacts the root of the ciliary muscle.

[0056] The present invention may optionally relate to a second method of insertion of an ocular implant for insertion between the sclera and uveal tissue, where the implant may conform to the implant described above, the method comprising the steps of: - Making at least one incision extending to the ciliary body. - inserting an implant through said at least one incision and between the sclera and the ciliary body. - positioning the implant as close as possible to the trabecular meshwork so that said at least one protrusion contacts the root of the ciliary muscle.

[0057] In one embodiment of the first or second insertion method, the at least one incision is concentric with the limbus.

[0058] In one embodiment of the first or second insertion method, said at least one incision is perpendicular to the limbus.

[0059] In one embodiment of the first or second insertion method, the leading edge comprises at least one needle, the method comprising the step of creating at least one opening between the anterior chamber and the episcleral space, and the step of positioning the implant comprises inserting the at least one needle into the at least one opening between the anterior chamber and the episcleral space until the at least one protrusion contacts the root of the ciliary muscle.

[0060] In one embodiment of the first or second insertion method, the number of openings created between the anterior chamber and the episcleral space is equal to or greater than the number of perforation needles at the leading edge.

[0061] In one embodiment of the first or second insertion method, the leading edge comprises at least one needle having a piercing distal point, and the step of positioning the implant comprises piercing the root of the ciliary muscle with the piercing distal point until said at least one protrusion contacts the root of the ciliary muscle.

[0062] In one embodiment of the first or second insertion method, the method further includes injecting a viscoelastic material between the sclera and the ciliary body through the at least one incision to separate these two tissues prior to insertion of the implant. [Brief description of the drawings]

[0063] The accompanying drawings illustrate the invention.

[0064] [Figure 1] FIG. 1 is a highly schematic overall view showing an implant according to one embodiment of the present invention from the front, positioned around the cornea of ​​an eye.

[0065] [Diagram 2] FIG. 2 is a detailed view of the leading edge of an implant according to the invention, which comprises a number of protrusions enabling contact with the root of the ciliary muscle of the eye.

[0066] [Diagram 3] FIG. 13 is a detailed view of a leading edge of an implant according to the invention, comprising a number of protrusions forming a contact edge that extends along a circular path with different radii of curvature.

[0067] [Figure 4] FIG. 2 is a side view of an implant according to the present invention, the leading edge of which is thinner than the body of the implant.

[0068] [Diagram 5] FIG. 2 is a side view of an implant according to the present invention, the leading edge of which is thinner than the body of the implant, the leading edge forming a localized thinned area on the lower or upper surface of the implant.

[0069] [Figure 6] FIG. 2 shows a first embodiment of a leading edge of an implant according to the invention, comprising a protrusion.

[0070] [Figure 7] FIG. 2 shows a second embodiment of a leading edge of an implant according to the invention, comprising a protrusion.

[0071] [Figure 8] FIG. 13 shows a third embodiment of a leading edge of an implant according to the invention, comprising two protrusions.

[0072] [Figure 9] FIG. 13 shows a fourth embodiment of a leading edge of an implant according to the invention, comprising two protrusions.

[0073] [Figure 10] FIG. 5 shows a fifth embodiment of the leading edge of an implant according to the invention, comprising two protrusions.

[0074] [Figure 11] FIG. 13 shows a sixth embodiment of a leading edge of an implant according to the invention, comprising two protrusions.

[0075] [Figure 12] FIG. 13 shows a seventh embodiment of the leading edge of an implant according to the invention, comprising two protrusions.

[0076] [Figure 13] FIG. 13 shows an eighth embodiment of a leading edge of an implant according to the invention, comprising two protrusions.

[0077] [Figure 14] FIG. 13 shows a ninth embodiment of a leading edge of an implant according to the invention, comprising two protrusions forming a contact edge extending along circular paths of different radii of curvature.

[0078] [Figure 15] FIG. 1 shows, highly diagrammatically, a first method of implant insertion.

[0079] [Figure 16] FIG. 2 shows, highly diagrammatically, a second method of implant insertion.

[0080] [Figure 17] FIG. 1 shows a simplified general form of an embodiment of an implant according to the present invention, shown generally in schematic form in the position of a human eye, positioned between the sclera and the ciliary body.

[0081] [Figure 18] FIG. 18 is a more detailed enlarged view of the structure of the iris angle without the implant of FIG. 17.

[0082] [Figure 19] FIG. 1 is a top view of a first embodiment of a needle intended to be inserted into the anterior chamber and an implant comprising multiple protrusions.

[0083] [Figure 20] FIG. 1 shows an implant with a second embodiment of a needle.

[0084] [Figure 21] FIG. 13 shows an implant with a third embodiment of a needle.

[0085] [Figure 22]FIG. 13 shows an implant with a fourth embodiment of a needle.

[0086] [Figure 23] FIG. 13 is a side view of an implant in which the needle is thinner than the body of the implant.

[0087] [Figure 24] FIG. 13 is a top view of an implant in which the width of the needle decreases from the proximal end attached to the body towards the distal end to facilitate insertion of the needle into the anterior chamber of the eye.

[0088] [Diagram 25] FIG. 13 is a side view of an implant in which the thickness of the needle is greater than the thickness of the body of the implant.

[0089] [Figure 26] FIG. 1 shows an implant with two needles intended to be inserted into the anterior chamber of the eye.

[0090] [Figure 27] FIG. 2 shows highly schematic views of the installation of an implant according to a third method.

[0091] [Figure 28] FIG. 13 is a side view of a needle with a piercing distal point having a beveled edge to allow for piercing tissue at the root of the ciliary muscle.

[0092] [Figure 29] FIG. 2 is a perspective view of a first example of a hollow implant having upper and lower surfaces separated by a central cavity.

[0093] [Diagram 30] FIG. 2 is a perspective view of a second example of a hollow implant, with an upper surface and a lower surface separated by a central cavity.

[0094] [Diagram 31] FIG. 31 is a side view of the implant of FIG. 30.

[0095] [Diagram 32] FIG. 13 shows a third example of a hollow implant with a central cavity separating the upper and lower surfaces and comprising a needle with a beveled piercing distal point.

[0096] [Diagram 33] FIG. 33 is a side view of the implant of FIG. 32. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0097] The inventive concepts are described more fully below with reference to the accompanying drawings, in which embodiments of the inventive concepts are shown. In the drawings, the size and relative size of elements may be exaggerated for clarity. Like numbers refer to like elements in all drawings. However, the inventive concepts should not be construed as limited to the embodiments disclosed herein, but may be embodied in many different forms. Rather, these embodiments are proposed so that this description will be thorough and will convey the scope of the inventive concepts to those skilled in the art.

[0098] References throughout the specification to "one embodiment" mean that the particular functionality, structure, or feature is included in at least one embodiment of the invention. Thus, the appearances of the phrase "in one embodiment" in various places throughout the specification do not necessarily refer to the same embodiment. Moreover, the particular functionality, structures, or features may be combined in any suitable manner in one or more embodiments. Additionally, the term "comprising" does not exclude other elements or steps.

[0099] The invention is illustrated with the aid of figures showing an ocular implant for insertion intended to collect aqueous humor from the anterior chamber into the suprachoroidal space to sustainably reduce intraocular pressure (IOP).

[0100] For the sake of clarity herein, an ocular implant for insertion may hereinafter be referred to by the term "implant."

[0101] The implant comprises a uveal compatible body, i.e., made of at least one material known for its uveal compatible properties, which give the body very low adhesion to ocular tissues, in other words, the at least one material is unlikely to deteriorate the upper and lower structures due to the body contacting those structures and their repetitive movements over time.

[0102] The body of the implant has three dimensions in space: thickness, and length and width perpendicular to the thickness. The ratio of length to width may be less than, equal to, or greater than 1. For example, the implant may have dimensions (width, length, thickness) of 4x5x0.1 mm, or 3x7x0.8 mm, or 6x3x0.6 mm. Furthermore, the thickness of the implant may vary between the leading and trailing edges, for example from 0.15 mm at the leading edge to 0.7 mm at the trailing edge. This variation may be gradual, random, throughout the anterior-posterior direction and / or locally.

[0103] The implant is preferably made in a single piece, i.e. formed as a monoblock single piece, and thus is not an assembly of multiple pieces secured together to form a body.

[0104] The body of the implant is preferably thin so that after placement between the sclera and uveal tissues it does not unacceptably deform the tissues above and below. Acceptable deformation of tissues is deformation that does not degrade the function of one and / or the other of those tissues. The thickness (e) of the body 22 of the implant is preferably 50-1000 μm.

[0105] The body of the implant has two opposing edges spaced apart from one another in one of two directions perpendicular to the thickness, the two opposing edges comprising a leading edge and a trailing edge opposite the leading edge relative to the body.

[0106] The leading edge is oriented towards or facing the anterior chamber of the eye and is intended to be positioned in contact with the posterior wall of the root of the ciliary muscle.

[0107] 1, eye 10 is highly schematic represented from the anterior with cornea 12, central pupil 14, and ciliary muscle root 118. When referring to ciliary muscle root 18 herein, it is meant the posterior wall of the ciliary muscle root.

[0108] The implant 20 comprises a body 22 having a leading edge 24 and a trailing edge 26. Side edges 28 and 30 extend on either side of the body between the leading edge 24 and the trailing edge 26. The shape of the implant in FIG. 1 is schematic. The purpose of FIG. 1 is to define the location of the implant 20 relative to the ciliary muscle root 118 and to identify the leading edge 24, the trailing edge 26, and the side edges 28, 30. The geometric characteristics of the implant 20 are described in detail below.

[0109] The trailing edge 26 is preferably convex. A convex edge curves away from the body 22 of the implant 20, or conversely, a concave edge reenters or curves toward the body 22 of the implant 20. Alternatively, the trailing edge 26 may be straight or concave.

[0110] In one embodiment, the convexity of the trailing edge 26 is extended by the side edges 28, 30. That is, no angle is formed between the side edges 28, 30 and the trailing edge 26.

[0111] In general, regardless of the implant shape, the trailing edge 26 must be far enough away from the leading edge to provide an effective separation effect, in practice the trailing edge is preferably at least 1.0 mm from the leading edge.

[0112] Generally, regardless of the implant shape, the length of the trailing edge 26 will not exceed 50% of the length of the leading edge.

[0113] Side edges 28, 30 are symmetrical with respect to one another, although in a variation not shown they may be asymmetrical with respect to one another.

[0114] The side edges 28, 30 may be radially arranged (the side edges converge at an imaginary point located in front of the leading edge), open (the side edges converge at an imaginary point located in front of the trailing edge), or parallel to one another.

[0115] The body 22 of the implant 20 has two opposing major surfaces separated from each other by a thickness of the body 22. The two opposing major surfaces comprise an upper surface and a lower surface separated by a thickness. The upper surface is intended to contact the sclera. The lower surface is intended to contact the ciliary body.

[0116] 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 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 top and bottom surfaces are flat.

[0117] In one embodiment, the body 22 may be hollow. Thus, the body 22 may form a central cavity between the upper and lower surfaces. The central cavity may be open to the exterior of the implant, for example at one or more lateral and posterior edges. This central cavity is free or partially free of material, particularly over an anterior-posterior distance.

[0118] In one embodiment of the implant, the body is formed by folding a plate so as to form a central cavity between at least two opposing portions of said plate. The body can therefore be formed by mainly two-dimensional elements, here plates, whose arrangement, here folding, can form a three-dimensional body having a thickness greater than the combined thickness of the two opposing portions of the plate. Part or all of the walls of the implant 20, i.e. the upper and lower faces, the side edges, and the front and rear edges, can be perforated. In other words, these walls can be manufactured in the form of a mesh in which an alternating sequence of material and holes appears.

[0119] The mesh can be obtained by removal of material or by weaving filaments of material. The implant 20 may be manufactured in the form of a woven, mainly two-dimensional, multi-walled structure that forms a three-dimensional envelope surrounding a central cavity. Such an embodiment using perforated walls allows for favorable collection and flow of aqueous humor. The implant 20 may also include a combination of perforated and parenchymal walls.

[0120] The leading edge 24 includes at least one protrusion 32 oriented towards the outside of the body 22. The at least one protrusion 32 protrudes from the body 20 when viewed in projection onto a plane including width and length, as shown in Figure 1. The protrusion 32 allows at least localized contact of the at least one protrusion on the root of the ciliary muscle.

[0121] By "localized" contact, it is meant that only a portion of the leading edge 24 is intended to contact the root of the ciliary muscle. Thus, the leading edge 24 is formed such that the entire leading edge 24 does not contact the root of the ciliary muscle.

[0122] The leading edge 24 may include a single protrusion 32 of material to maximize aqueous humor collection while simplifying the shape of the leading edge 24. Said protrusion 32 is preferably located at the level of the middle of the leading edge 24 to allow better positioning of the implant 20 over the root of the ciliary muscle.

[0123] 2 , the leading edge 24 includes a contact edge 36 that forms a contact area between the leading edge 24 and the root of the ciliary muscle 118. Each protrusion 32 of said at least one protrusion 32 includes a contact edge 38 at the level of its distal end 40. If the leading edge includes multiple protrusions 32, the contact edge 36 is formed by multiple contact edges 38 carried by the protrusions 32.

[0124] In the case of multiple protrusions 32, they collectively form a discontinuous or localized 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 multiple contact edges 38. Furthermore, the contact may be localized because it is achieved by only a portion of the leading edge 24, rather than the entirety of the leading edge 24. The contact edge 36 preferably allows for discontinuous and localized contact, in the sense that contact is achieved over multiple localized contact areas.

[0125] Increasing the number of contact edges 38 improves positioning and stability of the implant 20 relative to the root of the ciliary muscle 118, improving collection of aqueous humor.

[0126] The at least one protrusion 32 may be configured to allow at least one localized 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 localized contact is theoretical. By deformation, the tissue generates contact over a contact area around this theoretical contact point. Thus, a "localized" contact means a contact area localized at the level of the part of the protrusion 32 that has a curved or convex profile. Thus, the contact edge 38 of the at least one protrusion 32 may have a convex profile that allows a theoretical localized contact with a spherical surface such as the root of the ciliary muscle.

[0127] The convex profile of the contact edge 38 may be created by a curved edge or by multiple straight edges along a curved profile.

[0128] The at least one protrusion 32 may be configured to enable at least one line contact on the root of the ciliary muscle 118. Thus, the contact edge 38 of the at least one protrusion 32 may have a straight or concave profile that enables line contact with a spherical surface, such as the root of the ciliary muscle.

[0129] The concave profile of the contact edge 38 may be created by a curved edge or by multiple straight edges along the curved profile.

[0130] The at least one projection 32 extends along a longitudinal axis A that passes through the contact edge 38 .

[0131] The at least one protrusion 32 forms a protrusion or step relative to the body 22 that allows for localized contact with a convex surface. The protrusion or step is preferably spaced from the remainder of the body 22 by a distance of 0.05 mm or greater. 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.

[0132] The at least one protrusion 32 may be elongate in shape, and has a transverse dimension T that is smaller than a longitudinal dimension L at the level of the proximal end 42 in a direction perpendicular to the longitudinal axis A, based on a projection onto a plane including width and length.

[0133] Alternatively, the at least one protrusion 32 may have a flattened shape, i.e., when viewed in a projection onto a plane including width and length, the transverse dimension T at the level of the proximal end 42 in a direction perpendicular to the longitudinal axis A may be greater than the longitudinal dimension L.

[0134] The side walls of the at least one protrusion 32 may be straight, curved, or a combination of straight and curved walls.

[0135] The at least one projection 32 may also include a shape that allows the at least one projection 32 to change width, i.e., transverse dimension T, or to deform elastically, without permanent deformation, along the longitudinal axis A. In particular, the shape that facilitates this longitudinal elastic deformation may be S-shaped or spring-shaped.

[0136] More generally, the contact edge 36 defines a contact profile 44 of the leading edge on the root of the ciliary muscle. If the leading edge 24 includes multiple protrusions 32, each contact edge 38 extends along its contact profile 44.

[0137] The contact profile 44 preferably extends along a concave trajectory to improve the contact between the leading edge 24 and the convex surface that follows the root of the ciliary muscle. The concave of the trajectory of the contact profile 44 is considered to face the implant 20. Thus, the concave trajectory refers to the fact that the concave edge 36 extending along its profile follows a concave contact edge that can optimally fit to a convex surface such as the root of the ciliary muscle.

[0138] The contact profile 44 may extend along a circular path, in particular in a manner that facilitates the manufacture of the implant, in particular when it is manufactured by machining. Each contact edge 38 therefore extends along a portion of this circular path.

[0139] The contact profile 44 may also extend along different trajectories. To this end, the contact profile 44 comprises a number of contact profile portions 46 which collectively form the contact profile 44. The contact profile portions 46 may be carried by one or more contact edges 38, i.e. protrusions 32.

[0140] In order to obtain a good compromise between the positioning of the implant 20 and the improvement of the collection of aqueous humor, it is possible to form groups, for example pairs, of the projections 32 that extend along the same trajectory. Thus, the leading edge 24 can include a first group of projections 32 that extend along a first trajectory that can optimally adapt to the shape of a first ciliary muscle, and a second group of projections that extend along a second trajectory that can optimally adapt to the shape of a second ciliary muscle. These groups or pairs of projections 32 are preferably distributed along the leading edge 24 in order to improve the stability of the contact with the root of the ciliary muscle.

[0141] These contact profile portions 46 may extend along different trajectories, in particular to obtain a shape of the leading edge 24 that can conform to multiple surface shapes. Thus, it is possible for one or more contact profile portions 46 to extend along a first trajectory and one or more contact profile portions 46 to extend along a second trajectory. The trajectories may be of different shapes, different positions, different orientations, or a combination of the above different attributes. Thus, the contact profile 44 may extend continuously along a linear and / or concave trajectory.

[0142] The contact profile 44 may in particular extend along at least one circular trajectory. Thus, the contact profile 44 may extend along multiple circular trajectories. In other words, the contact edges 38 of the projections 32 may extend along different circular trajectories.

[0143] In one advantageous embodiment, the contact profile 44 may extend along a circular path having different radii of curvature. In other words, the contact edge 38 of the protrusion 32 may extend along circles of different diameters. It is therefore possible to have a shape of the protrusion 32 that is specifically shaped and oriented to conform to convex surfaces of different radii. As a result, the leading edge 24 can be specifically adapted to eyes having different anterior chamber diameters.

[0144] These circular tracks preferably have centers located in the same transverse direction relative to the leading edge 24 when viewed in projection onto a plane containing the width and length.

[0145] In one advantageous embodiment, the leading edge 24 includes a group of protrusions 32 that extend along circular paths having different radii of curvature. In other words, the contact profile 44 of the contact edge 36 includes at least one first profile portion that extends along a first circular path having a first radius of curvature and at least one second profile portion that extends along a second circular path having a second radius of curvature that is greater than the first radius of curvature, allowing the contact edge to contact the ciliary muscle root having multiple possible anatomical radii.

[0146] The first profile portion is formed at the level of the central region of the contact edge and the second profile portion is arranged at the level of the peripheral region of the contact edge, so that the second profile portions are arranged on either side of the first profile portion along the contact edge when the contact edges, and thus the projections 32, extend along this second locus.

[0147] It has been found that the diameter of the anterior chamber of the eye can vary between 10.75 mm and 13.75 mm. Accordingly, leading edge 24 is shaped such that at least one of the circular orbits has a radius of curvature that is greater than 4.5 mm and less than or equal to 6 mm. Additionally or alternatively, leading edge 24 is shaped such that at least one of the circular orbits has a radius of curvature that is greater than 6 mm and less than or equal to 7.5 mm.

[0148] Thus, the leading edge 24 comprises at least one group of protrusions 32 extending along a circular path having a radius of curvature of at least 4.5 mm and at most 6 mm, and at least one group of protrusions 32 extending along a circular path having a radius of curvature of more than 6 mm and at most 7.5 mm.

[0149] In the 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 not elastically deformable and may have one or more anatomical curvatures. In other words, the implant 20 can be inserted without elastic deformation into its position relative to the root of the ciliary muscle.

[0150] In the second configuration, the body 22 of the implant 20 is elastically deformable so that it can be folded without permanent deformation in order to be manipulated using a microinstrument or injected using an ophthalmic injection system. Such a body 22 returns to its original deformed (rest) position when it is no longer subjected to a folding force. In this embodiment, the implant 20 is thus an elastically deformable implant and can have one or more anatomical curvatures. In other words, the implant 20 is only intended to be placed in a deformed state for insertion through tissue.

[0151] In the third configuration, the body 22 of the implant 20 is elastically deformable so that it can be folded without permanent deformation in order to be manipulated using a microinstrument or injected using an ophthalmic injection system. When such a body 22 is no longer subjected to a folding force, it remains in place in a deformed state corresponding to the anatomical space between the sclera and the uveal tissue. In other words, the implant 20 is intended to be positioned against the root of the ciliary muscle in a deformed state not only during insertion through the tissue, but also during use.

[0152] When positioned between the sclera and the uveal body, the body 22 of the implant 20 is configured such that at least one of the circular orbits has a radius of curvature of 4.5 mm or more and 6 mm or less. Additionally or alternatively, the body 22 of the implant 20 is configured such that at least one of the circular orbits has a radius of curvature of greater than 6 mm and 7.5 mm or less. These ranges of radius of curvature values ​​are for each of the three configurations above. In the third configuration, these ranges are for the body of the implant 20 in a deformed state and positioned between the sclera and the uvea. Thus, the body of the implant 20 conforms to the anatomical variability of the patient's eye when positioned between the sclera and the uvea, regardless of the configuration of the body 22.

[0153] In a deformed state in which it can be used as an ophthalmic implant for insertion between the sclera and uveal tissue, the body 22 of the implant 20 has a curvature in a direction perpendicular to a plane defined by the two dimensions perpendicular to the thickness, which curvature is preferably concave in order to optimally fit the patient's anatomy.

[0154] The implant body has a Young's modulus of 30 to 60 kg / cm 2 In this case, the body of the implant may comprise at least one material selected from PTFE, polysiloxane, hydrophilic or hydrophobic acrylate hydrogels.

[0155] Alternatively, the implant body has a Young's modulus of 30,000 to 2,500,000 kg / cm 2 In this case, the body of the implant may include at least one material selected from polypropylene, polymethylmethacrylate, titanium, stainless steel, and nitinol.

[0156] The body of the implant may have the property of releasing one or more substances. Such substances are, for example, anti-infective and / or anti-inflammatory substances. Thus, they may be antibiotics and / or cortisone or anti-cortisone substances.

[0157] The body 22 of the implant 20 may be completely or locally coated with one or more substances or have an appropriately selected surface condition such that cell growth into the implant 20 from the surrounding tissue is inhibited or limited by the substance or substances or surface conditions.

[0158] An example of a leading edge 24 including a group of protrusions that extend along circular paths having different radii of curvature is shown in FIG.

[0159] In this example, the leading edge 24 includes three groups of protrusions 32, namely, a first group of protrusions 32a, a second group of protrusions 32b, and a third group of protrusions 32c. Three circular orbits are represented, namely, a first orbit 48a, a second orbit 48b, and a third orbit 48c. The radius of curvature of the orbits increases from the first orbit 48a to the third orbit 48c. In other words, the third orbit 48c has a larger radius of curvature than the second orbit 48b, which in turn has a larger radius of curvature than the first orbit 48a.

[0160] The contact edges 38 of the first group of protrusions 32a extend along a first track 48a, the contact edges 38 of the second group of protrusions 32b extend along a second track 48b, and the contact edges 38 of the third group of protrusions 32c extend along a third track 48c.

[0161] In this example of Fig. 3, each group includes two protrusions 32. In general, each group of protrusions 32 may include at least one protrusion 32. Furthermore, the leading edge 24 may include multiple groups of protrusions 32 each extending along multiple circular paths having different radii of curvature. Thus, it is possible to manufacture a leading edge that can accommodate multiple, or even an infinite number, of different ciliary muscle root anatomies.

[0162] 4, the thickness of the leading edge 24 may be reduced relative to the thickness of the body 22. This reduced thickness may occur in the at least one protrusion 32 as well.

[0163] This thinning of the leading edge 24 preferably occurs at the end of the leading edge 24 which allows for a reduced area of ​​the leading edge 24 that abuts the root of the ciliary muscle 118 for a given thickness of the body 22. This allows for space between the root of the ciliary muscle 118 and the body 22 of the implant 20, thereby improving the collection and circulation of aqueous humor towards the body of the implant.

[0164] The leading edge 24 comprises an upper portion 50 and a lower portion 52. The thickness of the leading edge is thus reduced at the level of the upper portion 50. The contact edge 36 is carried by the lower portion 52 of the leading edge 24.

[0165] This thinned portion of leading edge 24 preferably extends along longitudinal axis A from contact edge 36 to body 22 a distance of 1.5 mm or less.

[0166] The thinning is preferably effected over the entire length of the leading edge 24. Alternatively, the thinning occurs over only a portion of the length of the leading edge 24.

[0167] With reference to FIG. 5 , the leading edge 24 may also include a local thinning 54 of thickness. This local thinning 54 is formed on the upper or lower surface of the implant 20. This local thinning 54 is configured to promote elastic deformation of the leading edge 24, in particular in its distal portion, thereby making it possible to improve the contact area between the root of the ciliary muscle 118 and the leading edge 24. Indeed, under the action of a force pressing the implant 20 along the longitudinal axis A against the root of the ciliary muscle, the local thinning 54 makes it possible to rotate the distal portion of the leading edge 24 towards the local thinning 54. This deformation of the leading edge 24 promotes contact between the leading edge 24 and the root of the ciliary muscle 118.

[0168] The body of the implant may be pierced by openings passing through its thickness. These openings are passageways for the flow of aqueous humor through the body 22 from one of the opposing major faces to the other opposing major face. The body may be pierced by a number of other openings located in other planes as well.

[0169] The body 22 of the implant 20 may be provided with a relief on at least one of its two opposing major faces that is capable of promoting the flow of aqueous humor over said at least one major face.

[0170] The relief may take the form of, for example, channels or grooves on the opposing faces. The channels or grooves may be formed on the surface or through the body 22. The channels or grooves are preferably disposed substantially parallel to a direction extending from the leading edge 24 towards the trailing edge 26 of the body 22.

[0171] The relief may take the form of depressions on said at least one major face or in the form of roughness imparted thereto.

[0172] It should be noted that the body 22 of the implant 20 can combine through openings, channels / grooves, and recesses.

[0173] 6-14 depict an embodiment of the body 22, and most importantly the leading edge 24, of the implant 20. FIG.

[0174] 6 and 7 show examples of different shapes of leading edge 24, including a single protrusion 32 that allows for localized contact. In the figures, the localized contact area between implant 20 and the root of the ciliary muscle is symbolically shown by a dot. As mentioned above, the localized contact area may be localized or linear.

[0175] In Figure 6, the leading edge 24 includes a protrusion 32 formed by a curved central portion extending between two retention arms 34. These retention arms 34 direct the aqueous humor to facilitate its flow toward the body 22 of the implant, thereby increasing the efficiency of aqueous humor collection.

[0176] More generally, the leading edge 24 may include at least one retention arm 34 that projects outwardly from the body. These retention arms 34 are not configured to contact the root of the ciliary muscle 118. The purpose of these retention arms 34 is to direct aqueous humor to promote its flow toward the body of the implant 22. The leading edge 24 preferably includes at least two retention arms 34, e.g., located on lateral edges of the leading edge 24.

[0177] In certain configurations, the projections 32 on the leading edge 24 can function as retaining arms, especially when the leading edge 24 includes at least two projections 32 .

[0178] Between the projection 32 and the retaining arm 34 a gap or collection recess 35 is formed.

[0179] 7, the protrusion 32 is an elongated protrusion. The protrusion 32 also extends centrally between two retaining arms 34. A collection recess 35 is also formed between the retaining arms 34 and the protrusion 32.

[0180] 6 and 7 includes a retaining arm 34. Alternatively, the leading edge 24 may not have a retaining arm 34.

[0181] 8-11 show examples of different shapes of the leading edge 24, including two protrusions 32 that allow local contact at the level of two regions of the root of the ciliary muscle 118. In these figures, the local contact region between the implant 20 and the root of the ciliary muscle 118 is symbolically indicated by a dot. As mentioned above, the local contact region may be localized or linear.

[0182] 8 to 11, the two protrusions 32 are formed at the level of the periphery of this front edge 24. In other words, the two protrusions 32 are formed at the level of the lateral ends of the front edge 24. A collecting recess 35 is formed between the two protrusions 32.

[0183] In all these examples of the leading edge 24 of Figures 8-11, the contact profile 44 of the contact edge 36 extends along a concave locus.

[0184] 8, 9, and 11, the two protrusions are elongated protrusions. Here, these two protrusions 32 form arms for retaining aqueous humor in the collection recess 35.

[0185] 10 are each formed by a straight, inclined portion of the leading edge 24. The straight, inclined portions intersect with each other at the level of the center of the leading edge 24 to form a collection recess 35.

[0186] 12 and 13 show examples of different shapes of leading edge 24, including multiple protrusions 32 that allow localized contact at the level of multiple regions of the root of ciliary muscle 118. In these figures, the localized contact regions between implant 20 and the root of ciliary muscle 118 are symbolically indicated by dots.

[0187] 12 and 13, the contact profile 44 of the contact edge 36 extends along a concave locus.

[0188] 12 and 13, the projections 32 form contact edges 38 that are all aligned on the same locus, specifically the same circular orbit.

[0189] In FIG. 12, the projections 32 form linear contact edges 38 to obtain a linear contact area with the root of the ciliary muscle 118 .

[0190] Collection recesses 35 are formed between the protrusions 32. Collection channels or grooves are formed between these collection recesses 35 and the trailing edge 26. These collection recesses 35 have a circular or pseudo-circular shape.

[0191] In FIG. 13, the projections 32 form curved contact edges 38 to obtain a localized contact area with the root of the ciliary muscle 118.

[0192] Collection apertures are formed at the lateral ends of the leading edge 24. Generally, collection apertures may be formed all along the leading edge 24. Collection channels or grooves extend from the leading edge 24 toward the trailing edge 26 to allow for the flow of aqueous humor.

[0193] FIG. 14 shows an example of a leading edge 24 whose contact profile 44 extends along multiple circular paths having different radii of curvature.

[0194] Similar to Figure 3, the leading edge of Figure 14 includes multiple groups of protrusions 32, each of whose contact edges 38 extends along a different trajectory. In particular, the example of Figure 14 includes four pairs of protrusions 32 that extend along four circular trajectories having different radii of curvature.

[0195] To increase the flow of aqueous humor, a passage can be created through the root of the ciliary muscle to establish a direct communication between the anterior chamber and the episcleral space of the eye (cyclodialysis). Said passage is obtained by an incision made during the surgery to implant the implant. However, without additional precautions, this opening will close rapidly due to natural scar formation. It can be made more permanent if a non-absorbable, non-deformable object keeps it open.

[0196] To that end, Figure 19 shows an embodiment of the invention in which the leading edge 24, when viewed in projection in a plane including width and length, includes a local extension that protrudes from the body 20. This local extension 37, called a needle and distinct from the protrusion defined above, extends beyond the contact profile 44 and is intended to pass completely through the root of the ciliary muscle so as to be able to establish a long-lasting opening between the anterior chamber and the episcleral space.

[0197] The leading edge 24 may include one or more needles 37 .

[0198] The at least one needle 37 extends along a longitudinal axis A through a distal point 56 .

[0199] The at least one needle 37 may be elongated in shape. When viewed in a projection in a plane containing width and length, the needle 37 may have a transverse dimension B, perpendicular to its longitudinal axis A, that is smaller than its longitudinal dimension H.

[0200] Alternatively, the at least one needle 37 may have a flattened shape, i.e., when viewed in a projection in a plane containing width and length, has a transverse dimension B perpendicular to the longitudinal axis A that is greater than its longitudinal dimension H.

[0201] The side walls of the at least one needle 37 may be straight, curved, or a combination of straight and curved walls.

[0202] The at least one needle 37 may also include a variation in width, i.e., transverse dimension B, or shape allowing to facilitate passage of the at least one needle 37 through the ciliary muscle. Such a shape must be complemented by a suitably selected distal shape to prevent withdrawal of the needle from the anterior chamber, in particular by enlargement of the distal point 56 relative to the base of the at least one needle and / or thickening of the distal point.

[0203] The thickness of the ciliary muscle root has been found to vary from 200 to 500 microns between different individuals. In a preferred embodiment of the invention, the at least one needle 37 has a longitudinal dimension H in the range of 0.2 to 2.5 mm.

[0204] In another preferred embodiment, said at least one needle 37 has a lateral dimension B in the range of 0.2 to 2.5 mm.

[0205] Referring to FIG. 23, the thickness of the distal point 56 of the at least one needle may be reduced relative to the thickness of the body 22, thereby providing an element that facilitates passage through the ciliary muscle.

[0206] Referring to FIG. 25, the thickness of the distal point 56 of the at least one needle may be increased relative to the thickness of the body 22, thereby configuring the device to resist withdrawal of the at least one needle from the anterior chamber.

[0207] The distal point 56 of the at least one needle 37 may include a thin section followed by a thick section to facilitate passage through the ciliary muscle and then resist withdrawal thereof.

[0208] The thinning and thickening can be implemented in a plane perpendicular to the thickness and / or in the plane of the thickness of the implant 20 .

[0209] At least one needle 37 may be pierced by a longitudinal opening or may include grooves or recesses that allow the passage of aqueous humor flow through the ciliary muscle.

[0210] At least one needle may be located either on a lateral edge of the implant 20 or between two prongs 32 .

[0211] Said at least one needle 37 may have a piercing distal point 57 configured to pierce the wall of the root of the ciliary muscle without forming a pre-opening in said wall. In this case, the needle 37 is self-piercing, since it allows it to be inserted through the tissue without a previous opening. The piercing ability of the piercing distal point 57 can be obtained by one or more chamfered edges at the level of the distal end of the needle, so that the piercing distal point 57 has a triangular or truncated triangular cross section in a plane perpendicular to the thickness of the implant 20. Figure 28 shows an example of a needle comprising a piercing distal point 57.

[0212] FIG. 19 shows an example of an implant 20 including four protrusions 32 and a needle 37 whose longitudinal distance H is greater than its lateral distance B.

[0213] 22 shows an example of an implant 20 that includes four projections 32 and a needle 37 whose longitudinal distance H is less than its lateral distance B. The needle further includes an internal channel and groove.

[0214] FIG. 24 shows an example of a shape of the at least one needle that allows for easier insertion through the ciliary muscle.

[0215] In FIG. 20, the distal point of at least one needle 37 has a first example of a shape that allows for ease of insertion through the ciliary muscle and resistance to withdrawal.

[0216] In FIG. 21, the distal point of at least one needle 37 has a second example of a shape that allows for ease of insertion through the ciliary muscle and resistance to withdrawal.

[0217] FIG. 26 shows an implant 20 having two needles 37 and one prong 32 .

[0218] 29-33 represent an embodiment of an implant 20 in the form of a hollow body 22. A central cavity is thus formed between the upper and lower faces of the body 22. The upper and lower faces are connected to each other at the level of one of the edges of the body 22, preferably at the level of the front edge 24. The body 22 can be obtained by one plate folded on itself. The junction between the upper and lower faces at the level of the front edge 24 also forms at least one protrusion 32.

[0219] A needle 37 may also be formed on the leading edge 24. This needle 37 is also preferably hollow. The needle 37 includes at least two walls, an upper wall and a lower wall.

[0220] FIG. 15 shows the implantation of an implant 90 using a first implantation method according to an embodiment of the present invention. The implant 90 is represented in a purposefully simplified manner, but is in accordance with the invention described above. This first method is used to complement conventional anti-glaucoma surgery or any intraocular surgery in which it is desired to reduce intraocular pressure. A trabeculectomy and sclerotomy require the incision of one or more scleral flaps of the eye to be lifted, continuing the intervention. The scleral flap 92 (shown in dotted lines in FIG. 15) is obtained by incising the sclera in one or two planes and to varying depths, and has three sides, namely two substantially parallel incisions 92a, 92b extending from the cornea 12 and away from the latter, and a third incision 92c perpendicular to the other two incisions and away from the cornea. The resulting cuts by the three incisions form one or more scleral flaps. After lifting the scleral flap, two incisions (see 94a, 94b in FIG. 15) are made inside the flap 92, extending down to the ciliary body, so that an implant can be slid between the deep scleral plane and the ciliary body. The incisions are spaced, for example, at least 2 mm apart.

[0221] In a variation not shown, a single incision is made in the scleral plane to achieve the same purpose.

[0222] The implantation method used may then include the introduction of a viscoelastic material, for example of hyaluronic acid type, between the sclera and the ciliary body, through at least one of the incisions made, separating these two tissues previously back to back, which makes it possible to implant the implant without trauma to the upper and lower structures.

[0223] This step is carried out using an injection device such as an injection cannula with a diameter of 20-30 g.

[0224] A small amount of material, e.g. 0.05 mm 3 is injected.

[0225] The surgeon creates as many openings between the anterior chamber and the episcleral space as there are needles 37 included in the implant 20. These openings are created at the locations of the needles.

[0226] If the surgeon desires, a supplemental opening may be created between the anterior chamber and the episcleral space.

[0227] This or these openings may be produced by incision or cutting, for example by mechanical action (scalpel, spatula, ...) or by laser. Supplementary openings can be made during or after the operation.

[0228] The implantation method also includes introducing an instrument, such as foam-edged forceps, through one of two incisions 94a, 94b that extend depthwise to the ciliary body. The forceps exits through the incision to grasp the implant and position it between the sclera and the ciliary body.

[0229] In a subsequent step, a microsurgical instrument such as a foam-edged spatula is used to position the implant 90 as close as possible to the trabecular meshwork (concentric with the limbus) to maximize collection of aqueous humor, as described above.

[0230] Other types of instruments or devices, such as injectors, may be used that allow for the implantation and deployment of the implant and its positioning within the space between the sclera and the ciliary body (suprachoroidal space).

[0231] In another step, the scleral flap is folded and optionally sutured.

[0232] The first method described also applies to implanting multiple implants according to the invention: generally, at least one different incision (even two in the example of Fig. 15) is made for implanting each different implant.

[0233] 16 illustrates the implantation of an implant 100 using a second implantation method according to an embodiment of the present invention. The implant 100 is depicted in a purposefully simplified manner, but is consistent with the invention as described above.

[0234] This approach is very similar to the first, except that the second approach may constitute an intervention in its own right, rather than complementing traditional interventions.

[0235] in this way, - two incisions 102a, 102b, preferably radial or preferably parallel to each other (like incisions 94a, 94b in Fig. 15), are made in the cornea, the front ends of the incisions being located between 0-3 mm posterior to the limbus (the transition area between the cornea and the sclera) and having a length of, for example, 1-4 mm, continuing into the ciliary body. - A viscoelastic substance of hyaluronic acid type may be injected through one of the two incisions. If necessary, depending on the surgeon's requirements or intentions, an opening between the anterior chamber and the episcleral space is created by the steps described for the first method. - The sclera is lifted to allow for the insertion and positioning of the implant 100. The insertion steps are identical to those described for the first method above. - The final step of suturing the incision is again optional.

[0236] In a variant not shown, in this second method a single incision is made, which is sufficient to insert the implant between the sclera and the ciliary body.

[0237] 27 illustrates the implantation of an implant 110 using a third implantation method according to one embodiment of the present invention. The implant 110 is depicted in a purposefully simplified manner, but is consistent with the invention as described above.

[0238] The second method described also applies to implanting multiple implants according to the invention: generally, at least one different incision (even two in the example of Fig. 27) is made to implant each different implant.

[0239] The method may be performed to complement conventional filtration surgery or independently of any other intervention.

[0240] In this method, a circular incision 112 is made concentric with the limbus, for example between 1-5 mm from the limbus over a distance of 0.5-4 mm.

[0241] A hyaluronic acid type viscoelastic may be injected through this incision.

[0242] The surgeon creates as many openings between the anterior chamber and the episcleral space as there are needles 37 included in the implant 20. These openings are at the locations of the needles. The surgeon may wish to create additional openings between the anterior chamber and the episcleral space.

[0243] This or these openings may be produced by incision or cutting, for example by mechanical action (scalpel, spatula, ...) or by laser. Supplementary openings can be made during or after the operation.

[0244] The implant is then inserted under the sclera with forceps, along an axis perpendicular to the limbus, in the direction of the anterior chamber, until the projections of the implant contact the root of the ciliary muscle 118. For implants 110 that include one or more needles 37, this means that the needles pass through the openings made by the surgeon and then reside in the inner chamber.

[0245] Other types of instruments or devices, such as injectors, may be used that allow for implantation of the implant, deployment of the implant, and positioning it within the space located between the sclera and the ciliary body (suprachoroidal space).

[0246] If the entire implant is not inserted under the sclera, the remaining posterior portion of the implant is pushed under the sclera in a direction away from the anterior chamber.

[0247] The final step of suturing the incision is again optional.

[0248] In embodiments in which the needle 37 includes a distal perforation point 57, the surgeon may omit making one or more incisions between the anterior chamber and the episcleral space as described for the three previous methods, in which case the step of positioning the implant 20 relative to the root of the ciliary muscle includes perforating the root of the ciliary muscle with the distal perforation point 57 to insert the needle 37 into the anterior chamber until the at least one prong 32 contacts the root of the ciliary muscle.

[0249] It should be noted that the implants 90, 100 and 110 shown in Figures 15, 16 and 27 may be any of the implants described above. The implant implantation method described above applies to any implant of the present invention, particularly an ophthalmic implant for permanent insertion between the sclera and uveal tissue, comprising an integrally formed uveal compatible thin body, the body of the implant including two opposing edges spaced apart from each other in one of two directions perpendicular to the thickness. The implant may further include any one, "more than one" or "all" of the features described in the general description and in the various embodiments and variations.

[0250] The third method described also applies to implanting multiple implants according to the invention. Generally, at least one different incision is made for implanting each different implant.

[0251] FIG. 17 shows a cross-sectional view of an implant according to one embodiment of the present invention implanted using one of the methods described above.

[0252] The cross-section of this portion of the eye 110 depicts the anterior chamber 112 , which is disposed between the cornea 114 and the lens 116 and whose periphery is defined by the iris 119 .

[0253] The posterior chamber 120 is disposed behind the iris 119 .

[0254] The sclera 122 is connected to the periphery of the cornea 114 via the limbus 124 (the area of ​​change in radius of curvature between the sclera and the cornea). The sclera 122 is connected to the iris 119 and covers the ciliary body 128, which includes the ciliary muscle 130 against which the sclera 122 abuts.

[0255] The trabecular meshwork 134 , located between the cornea and the iris, acts as a filter, allowing the aqueous humor circulating within the anterior chamber 112 to pass through.

[0256] Schlemm's canal 136 is located behind the trabecular meshwork 134 between the sclera and the cornea.

[0257] The various arrows F1, F2, F3 and F4 indicate the path or trajectory taken by the aqueous humor. - F1 represents the conventional path or flow of aqueous humor entering the anterior chamber 112. - F2 represents the diffusion path or flow of aqueous humor to enter the anterior chamber 112. - F3 represents the conventional pathway or flow of aqueous humor leaving the anterior chamber 112 via the trabecular meshwork 134 towards Schlemm's canal 136. - F4 represents the conventional uveoscleral outflow of aqueous humor leaving the anterior chamber 112.

[0258] As mentioned above, an implant 140 according to an embodiment of the present invention is placed 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 (through its concave anterior edge) in order to exert a permanent spacing effect in the most appropriate place while respecting the insertion of the ciliary muscle 130 into the scleral ridge. Figure 18 is a more detailed enlarged view of the structure of the iris angle without the implant. As shown in this figure, the scleral ridge 132 into which the ciliary muscle 130 inserts is located above the posterior part 134a of the trabecular meshwork 134.

[0259] The spacing created between the sclera and the ciliary body in this position allows for permanent collection of aqueous humor in a location as close as possible to the area of ​​uveoscleral outflow (the spacing effect creates an area of ​​low resistance to aqueous humor flow). Positioned in this way, such implants achieve significant improvements in terms of increasing uveoscleral outflow.

[0260] The uveoscleral outflow is increased by a supplementary flow fraction through the posterior part of the trabecular meshwork, as shown above and below the implant by arrows F5 in Figure 17. This supplementary flow fraction is obtained as close as possible to the root 118 of the ciliary muscle, but without damaging the latter, thanks to the spacing effect of the implant between the sclera and the ciliary body.

Claims

1. 1. An ophthalmic implant (20) for permanent insertion between the sclera and uveal tissue, comprising: The implant (20) comprises a uveitis-compatible body (22), the body having three dimensions in space, namely length and width, which are perpendicular to each other and perpendicular to the thickness, the body of the implant comprising a first or anterior edge (24) oriented towards the anterior chamber of the eye and intended to come into contact with the root of the ciliary muscle, and a second or posterior edge (26) opposite the anterior edge (24) relative to the body (22), An ophthalmic implant, wherein the leading edge has at least one protrusion (32) oriented toward the outside of the body (22) to enable at least one local contact of the at least one protrusion (32) on the root of a ciliary muscle (118) based on a projection in a plane including width and length.

2. 10. The ophthalmic implant (20) of claim 1, An ophthalmic implant, wherein the leading edge (24) includes a plurality of protrusions (32) oriented toward the outside of the body (22), the protrusions collectively forming a discontinuous or localized contact edge (36) on the root of the ciliary muscle (118).

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

4. 4. An ophthalmic implant (20) according to claim 3, comprising: The ocular implant, wherein the contact profile (44) of the contact edge (36) extends along at least one circular orbit (48a, 48b, 48c).

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

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

7. 7. An ophthalmic implant (20) according to claim 6, comprising:

1. An ophthalmic implant, wherein the contact profile (44) of the contact edge (36) includes at least one first profile portion extending along a first circular orbit having a first radius of curvature and at least one second profile portion extending along a second circular orbit having a second radius of curvature greater than the first radius of curvature, allowing the contact edge (36) to contact a root of the ciliary muscle having a plurality of possible anatomical radii.

8. 8. An ophthalmic implant (20) according to claim 7, comprising: An ocular implant, wherein the first profile portion is formed at the level of a central region of the contact edge and the second profile portion is arranged at the level of a peripheral region of the contact edge.

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

10. 5. An ophthalmic implant (20) according to claim 4, comprising: An ophthalmic implant, wherein at least one of said circular orbits (48a, 48b, 48c) has a radius of curvature of 4.5 mm or more and 6 mm or less.

11. 5. An ophthalmic implant (20) according to claim 4, comprising: An ophthalmic implant, wherein at least one of said circular orbits (48a, 48b, 48c) has a radius of curvature greater than 6 mm and less than or equal to 7.5 mm.

12. 5. An ophthalmic implant (20) according to any one of claims 1 to 4, comprising: An ocular implant, wherein said at least one protrusion (32) is configured to enable at least one localized contact on the root of a ciliary muscle (118).

13. 5. An ophthalmic implant (20) according to any one of claims 1 to 4, comprising: An ocular implant, wherein the at least one protrusion (32) is configured to enable at least one linear contact on the root of the ciliary muscle (118).

14. 13. An ophthalmic implant (20) according to claim 12 in combination with claim 3, comprising: The ocular implant, wherein each protrusion (32) includes a contact edge (38), each said contact edge (38) extending along said concave locus.

15. 5. An ophthalmic implant (20) according to any one of claims 1 to 4, comprising: An ophthalmic implant, wherein the thickness of the leading edge (24) is reduced relative to the thickness of the body (22).

16. 16. An ophthalmic implant (20) according to claim 15, comprising: An ophthalmic implant, wherein the leading edge (22) comprises an upper portion (50) and a lower portion (52), the thickness of the leading edge (24) being reduced at the level of the upper portion (50).

17. 16. An ophthalmic implant (20) according to claim 15, comprising: An ophthalmic implant, wherein the body includes a local thinning (54) of thickness located posterior to the leading edge (24), and is configured to allow elastic deformation of the leading edge (24) by the action of a force pressing the leading edge (24) against a support surface, for example the root of the ciliary muscle (118).

18. 5. An ophthalmic implant (20) according to any one of claims 1 to 4, comprising: The ophthalmic implant, wherein the leading edge (24) extends outward from the body (22) and includes at least one needle (37) that protrudes beyond the at least one protrusion (32), and is capable of passing through the wall of the root of the ciliary muscle (118) when the at least one protrusion (32) is in contact with the root of the ciliary muscle (118).

19. 19. An ophthalmic implant (20) according to claim 18, comprising: The ophthalmic implant, wherein the needle (37) comprises a piercing distal point (57) configured to pierce the wall of the root of the ciliary muscle (118) without a pre-formed opening in the wall.

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

21. An ophthalmic implant (20) according to any one of claims 1 to 4, comprising: An ophthalmic implant, wherein the body (22) forms at least one aqueous humor collection recess that opens at the level of the leading edge (24).

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

23. 12. An ophthalmic implant (20) according to claim 10 or 11, comprising: An ophthalmic implant, wherein a body (22) of the implant is elastically deformable so that it can be folded without permanent deformation in order to be manipulated by a micro-instrument or injected using an ophthalmic injection system.

24. 24. An ophthalmic implant (20) according to claim 23 in combination with claim 10, comprising: An ophthalmic implant, wherein the implant body (22) is configured such that at least one radius of curvature of a circular orbit is 4.5 mm or more and 6 mm or less when the implant is placed in a deformed state corresponding to insertion of the implant body between the sclera and uveal tissue.

25. 24. An ophthalmic implant (20) according to claim 23 in combination with claim 11, comprising: An ophthalmic implant, wherein when the implant is placed in the deformed state corresponding to inserting the body of the implant between the sclera and uveal tissue, the body (22) of the implant is configured so that at least one radius of curvature of a circular orbit is greater than 6 mm and less than or equal to 7.5 mm.

26. 24. An ophthalmic implant (20) according to claim 23, comprising: An ophthalmic implant, wherein the body (22) of the implant has a concave curvature in a direction perpendicular to a plane defined by two dimensions perpendicular to the thickness of the implant in a deformed state that allows it to be used as an ophthalmic implant for insertion between the sclera and uveal tissue.

27. An ophthalmic implant (20) according to any one of claims 1 to 4, comprising: The implant body (22) has a resistance of 30 to 60 kg / cm ２ or 30,000 to 2,500,000 kg / cm ２ 1. An ophthalmic implant made of a material having a Young's modulus of

28. 5. An ophthalmic implant (20) according to any one of claims 1 to 4, comprising: An ophthalmic implant, wherein the body (22) of said implant 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.

29. An ophthalmic implant (20) according to any one of claims 1 to 4, comprising: An ophthalmic implant, wherein the body (22) of the implant comprises at least one material selected from PTFE, polysiloxane, hydrophilic or hydrophobic acrylate hydrogels.

30. 29. An ophthalmic implant (20) according to claim 28, comprising: An ophthalmic implant, wherein the body (22) of the implant has two opposing major faces separated from each other by a thickness of the body.

31. 31. An ophthalmic implant (20) according to claim 30, comprising: an implant, wherein the two opposing major surfaces include an upper surface and a lower surface separated by the thickness, and wherein the body of the implant has one of the following shapes in a direction perpendicular to a plane defined by two dimensions perpendicular to the thickness of the implant: - said upper surface is planar and said lower surface is concave; - said upper surface is planar and said lower surface is convex; - said upper and lower surfaces are convex; - said upper and lower surfaces are planar;

32. 31. An ophthalmic implant (20) according to claim 30, comprising: An ophthalmic implant, wherein the body (22) of the implant is pierced by openings passing through its thickness and / or the body of the implant is provided on at least one of its two opposite major faces with a relief adapted to promote the flow of aqueous humor across said at least one major face.

33. 33. An ophthalmic implant (20) according to claim 32, comprising: An ophthalmic implant, wherein the relief on said at least one major surface of said body (22) takes the form of recesses formed on said at least one major surface or of roughness imparted thereto.

34. An ophthalmic implant (20) according to any one of claims 1 to 4, comprising: An ophthalmic implant, wherein the thickness (e) of the body (22) of the implant is 50 to 1000 μm.

35. An ophthalmic implant (20) according to any one of claims 1 to 4, comprising: An ophthalmic implant, wherein the body (22) of the implant has properties that release one or more substances.

36. An ophthalmic implant (20) according to any one of claims 1 to 4, comprising: The ophthalmic implant wherein the posterior edge (26) is less than 1.0 mm from the anterior edge (24).

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