INTERPOSITIONAL OPHTHALMOLOGICAL IMPLANT HAVING ONE OR MORE EXGRESSIONS ON ITS UPPER SURFACE

Abstract

The invention relates to an ophthalmological implant (20) for permanent interposition between the sclera and the uveal tissue comprising a uveocompatible implant body (22) extending along a main axis (A) intended to be oriented along an anteroposterior direction, said implant body comprising an upper surface (32) intended to face the sclera and a lower surface (34) intended to be in contact with the uveal tissue, said implant body further comprising a first edge (24) called an anterior edge intended to be oriented towards the anterior chamber of an eye and a second edge (26) called a posterior edge opposite the anterior edge with respect to the implant body,characterized in that the lower surface is smooth and the implant body includes one or more protrusions (36) extending from the upper surface outwardly of the body to allow contact of the one or more protrusions with the sclera and to separate the sclera from the upper surface of the implant body. Figure for abstract: Figure 1,

Description

Title of the invention: INTERPOSITIONAL OPHTHALMOLOGICAL IMPLANT HAVING ONE OR MORE EXGRESSIONS ON ITS UPPER SURFACE Technical field

[0001] The present invention relates to an ophthalmic interposition implant for collecting aqueous humor from the anterior chamber to the supraciliary and suprachoroidal space to sustainably lower intraocular pressure (IOP). Technological background

[0002] Intraocular pressure results from a balance between the secretion of aqueous humor by the ciliary body and its flow through the meshes of the uveal trabecular meshwork via Schlemm's canal and its emunctories to the aqueous veins and the general circulation. A fraction of this flow, varying from 5 to 30% depending on age, occurs directly through the uveal trabecular meshwork between the sclera and the ciliary body; this is called uveo-scleral flow. The longitudinal fibers of the ciliary muscle, particularly during accommodation, play a role in tensioning the trabecular meshwork, which facilitates the uveo-scleral flow of aqueous humor. It is also through these longitudinal fibers of the ciliary muscle that the uveo-scleral flow flows.

[0003] In glaucoma, the flow of aqueous humor is reduced at the level of the trabecular meshwork, which in the majority of cases leads to an increase in intraocular pressure (IOP). Lowering this IOP is therefore the determining factor in the medical and / or surgical treatment of glaucoma. Surgical treatment is based on two possibilities: reducing the production of aqueous humor produced by the ciliary body (cyclo-weakening) or increasing the flow of aqueous humor by diverting it. This diversion is carried out in different ways: - by directly connecting the anterior chamber and the suprachoroidal space (cyclodialyse and its technical derivatives) with or without an implant, but the effect obtained is most often transient and insufficient. By detaching the insertion of the ciliary muscle from the scleral spur, this implantation technique eliminates the physiological mechanism of uveo-scleral flow in the surgical area.In addition, post-operative fibrosis extends beyond this area. It is also known that the part of the implant located in the anterior chamber can touch, even intermittently; the corneal endothelium, thus leading to a significant risk of progressive corneal edema. - by incising, from the anterior chamber, the trabeculum up to the canal of Schlemm to bypass the trabecular obstruction. This procedure can be supplemented by placing a stent in the canal, opening it to the anterior chamber, to maintain permanent direct access of the aqueous humor to the canal. Here too, the results are often partial and temporary, and do not exempt the continuation or resumption of medical treatment.

[0004] Filtering surgery remains a reference treatment and seeks to divert the aqueous humor under the conjunctiva to obtain the necessary pressure reduction. It can create a permanent full-thickness orifice in the trabeculum under a scleral flap: trabeculectomy. One of its variants leaves the internal part of the trabeculum in place, which is called non-perforating trabecular surgery (deep sclerectomy, viscocanalostomy).

[0005] However, filtering surgery has complications linked to insufficient filtration due to fibrosis of the filtration bubble (the filtration bubble is present between the sclera and the conjunctiva which is raised) or, conversely, excessive filtration which may be linked to the per-operative use of mitomycin C.

[0006] Furthermore, numerous attempts to normalize IOP using implants are known from the state of the art, either in conjunction with the surgical procedures mentioned above or used alone. However, these implants all deform the anatomy of the eye to a greater or lesser extent and / or divert / modify the natural flow paths.

[0007] Most known cyclodialysis implants aim to create a "forced conduit" of aqueous humor from the anterior chamber of an eye to the suprachoroidal area, bypassing the iris root and the supraciliary space. This is visible thanks to their design: - when they have the form of a plaque, they tend to force the circulation of aqueous humor by means of grooves, undulations or internal channels oriented anteroposteriorly, - when they are "tubular", it is a tube which collects the aqueous humor in the anterior chamber and evacuates it towards the suprachoroidal space.

[0008] It is known in particular from document WO 2016 / 156727 to avoid the complications associated with the breaching of the anterior chamber or the filtration bubble, by collecting the aqueous humor at the posterior face of the root of the iris without penetrating into the anterior chamber, and by draining the aqueous humor under the sclera towards the choroid, thus avoiding the creation of a filtration bubble.

[0009] Whether or not there is an incision of the iris root to access the anterior chamber, these implants design the aqueous circulation in the supraciliary space as a large flow that can be collected and then conducted into a channel. However, in normal anatomy, the sclera and the ciliary body are in direct contact and there is no vessel between the two, some preclinical and clinical work shows that The aqueous flow in this area is rather microscopic and diffuse. Furthermore, all these implants aim to conduct aqueous humor from the ciliary body to the choroidal space and bypass the absorptive capacities of the sclera. Plate-shaped implants are generally solid in shape and oppose a continuous or slightly hollowed surface to the sclera or in contact with it.

[0010] These implants do not meet the need for free circulation of aqueous humor in the supraciliary space and improvement of its absorption by the sclera.

[0011] A clinical trial conducted with a device aimed at creating a separation and an empty volume (in the sense that it is not filled by the device material) between the sclera and the ciliary body, without geometry aimed at conducting aqueous humor in the anteroposterior direction, surprisingly showed better results on IOP reduction, and therefore on aqueous humor circulation and drainage. This trial clearly showed that the main difference in IOP reduction comes from the surface area of scleral tissue available for aqueous absorption, and the volume created by the implant "without implant material" made available for aqueous circulation.

[0012] There is therefore a need for an ophthalmic implant which does not have the disadvantages mentioned above. In particular, there is a need for an ophthalmic implant which further promotes the absorption of aqueous humor by the sclera. Summary of the invention

[0013] For this purpose, the invention proposes an ophthalmological implant for permanent interposition between the sclera and the uveal tissue comprising a uveo-compatible implant body extending along a main axis intended to be oriented along an anteroposterior direction, said implant body comprising an upper surface intended to face the sclera and a lower surface intended to be in contact with the uveal tissue, said implant body further comprising a first edge called an anterior edge intended to be oriented towards the anterior chamber of an eye and a second edge called a posterior edge opposite the anterior edge with respect to the implant body, characterized in that the lower surface is smooth and the implant body comprises one or more protrusions extending from the upper surface towards the outside of the body to allow contact of the protrusion(s) with the sclera and to separate the sclera from the upper surface of the implant body.

[0014] The addition of a protrusion on the upper surface allows the sclera to be separated from the ciliary body and also to separate the sclera from the body of the implant, in particular from its upper surface. Thus, a significant portion of the sclera is separated from the ciliary body while being freed from contact with the implant. The protrusion allows a tenting effect to be achieved which allows better absorption of the aqueous humor by the sclera and therefore a reduction in intraocular pressure. (IOP). A tenting effect is defined as the lifting of scleral tissue by localized contact.

[0015] A clinical trial conducted with a device aimed at creating a separation and an empty volume (in the sense that it is not filled by the implant body material) between the sclera and the ciliary body, without geometry aimed at conducting aqueous humor in the anteroposterior direction, surprisingly showed better results on IOP reduction, and therefore on aqueous humor circulation and drainage. This trial clearly showed that the main difference in IOP reduction comes from the surface area of scleral tissue available for aqueous absorption, and the volume created by the implant "implant material void" made available for aqueous circulation.

[0016] Thus, the increase in the “empty” volume, or volume devoid of the implant body, between the sclera and the ciliary body greatly promotes the flow and circulation of aqueous humor.

[0017] Furthermore, having a smooth lower surface limits the risks of irritation and damage to the ciliary body, particularly during the placement of the implant. The lower surface is therefore not rough or does not have any protrusions.

[0018] According to an embodiment of the interposition ophthalmic implant, the outgrowth or each outgrowth defines an upper surface of contact with the sclera, said upper surface of contact of the outgrowth or of each outgrowth occupying in a unitary manner at most 50% of the upper surface when the upper surface is projected onto a top plane perpendicular to a normal to the upper surface.

[0019] According to one embodiment of the interposition ophthalmic implant, the or each outgrowth defines an outgrowth height taken along an axis perpendicular to the upper surface and passing through said outgrowth, said outgrowth height being greater than or equal to 10 μm, preferably greater than or equal to 50 μm, more preferably greater than or equal to 100 μm.

[0020] According to one embodiment of the interposition ophthalmic implant, the or each outgrowth defines an outgrowth height taken along an axis perpendicular to the upper surface and passing through said outgrowth, said outgrowth height being less than or equal to 2 mm, preferably less than or equal to 1 mm, more preferably less than or equal to 800 μm.

[0021] According to one embodiment of the interposition ophthalmic implant, said protrusion or one of the protrusions extends mainly along an anteroposterior direction extending between the first and second edges.

[0022] According to one embodiment of the interposition ophthalmic implant, said outgrowth or one of the outgrowths extends mainly along a direction perpendicular to the anteroposterior direction extending between the first and second edges.

[0023] According to one embodiment of the interposition ophthalmic implant, the upper surface comprises an anterior portion disposed near the first edge and a posterior portion disposed near the second edge, said protrusion or one of the protrusions is disposed in said posterior portion.

[0024] According to one embodiment of the interposition ophthalmic implant, the implant body comprises a plurality of protrusions extending from the upper surface toward the exterior of the body.

[0025] According to one embodiment of the interposition ophthalmic implant, the upper contact surfaces of the plurality of protrusions jointly occupy at most 50% of the upper surface when the upper surface is projected onto a top plane perpendicular to a normal to the upper surface.

[0026] According to one embodiment of the interposition ophthalmic implant, the plurality of protrusions comprises at least two protrusions disposed between the first and second edges.

[0027] According to one embodiment of the interposition ophthalmic implant, the lower surface comprises at least one recess communicating with the upper surface so as to allow the passage of a fluid from the lower surface to the upper surface.

[0028] According to one embodiment of the interposition ophthalmic implant, said at least one recess occupies at least 5% of the lower surface when the lower surface is projected onto a bottom plane perpendicular to a normal to the lower surface.

[0029] According to one embodiment of the interposition ophthalmic implant, the implant body defines a maximum length taken along an anteroposterior axis extending between the first and second edges as well as a maximum width taken along an axis perpendicular to the anteroposterior axis, the maximum width of the implant body being equal to or greater than the maximum length of the implant body. Brief description of the figures

[0030] The description which follows with reference to the appended drawings, given as non-limiting examples, will make it clear what the invention consists of and how it can be implemented. In the appended figures:

[0031] [Fig-1] [Fig.l] represents a schematic perspective view of an implant comprising a protrusion projecting from an upper surface of the implant body,

[0032] [Fig.2] [Fig.2] represents a schematic situational view in an eye human of a possible simplified general form of an implant according to the invention interposed between the sclera and the ciliary body.

[0033] [Fig.3] [Fig.3] represents a more detailed and enlarged view of the structure of the iridocorneal angle without the implant of [Fig.2],

[0034] [Fig.4] [Fig.4] represents a schematic perspective view of the implant of the [Fig.l] with the body of the implant having a groove,

[0035] [Fig.5] [Fig.5] represents a schematic perspective view of an example of production of the implant comprising a protrusion extending transversely to the anteroposterior direction of the implant,

[0036] [Fig.6] [Fig.6] represents a schematic side view of another example of a sheave implant placement with anterior and posterior edges and beveled and / or rounded outgrowth walls,

[0037] [Fig.7] [Fig.7] represents a schematic perspective view of another example of producing the implant comprising a plurality of protrusions and a body curved around an axis transverse to the anteroposterior direction of the implant,

[0038] [Fig.8] [Fig.8] represents a schematic perspective view of another example of making the implant comprising anterior and posterior edges offset in the anteroposterior direction of the implant,

[0039] [Fig.9] [Fig.9] represents a schematic perspective view of another example of producing the implant comprising a plurality of protrusions having convex or rounded walls,

[0040] [Fig. 10] [Fig. 10] represents a schematic perspective view of another embodiment of the implant comprising protrusions having different geometries from each other,

[0041] [Fig. 11] [Fig. 11] shows a schematic perspective view of another embodiment of the implant comprising through recesses extending between the lower and upper surfaces of the body of the implant, a plurality of substantially rectangular protrusions being distributed on the upper surface of the body, a plurality of protrusions extending from the anterior edge towards the posterior edge; Description of embodiment(s)

[0042] The inventive concept is described more fully below with reference to the accompanying drawings, in which embodiments of the inventive concept are shown. In the drawings, the size and relative sizes of elements may be exaggerated for clarity. Like numerals refer to like elements throughout the drawings. However, this inventive concept may be embodied in many different forms and should not be construed as being limited to the embodiments set forth herein. Instead, these embodiments are provided so that this description is complete, and communicates the scope of the inventive concept to those skilled in the art.

[0043] A reference throughout the specification to "an embodiment" means that a particular feature, structure, or characteristic described in connection with an embodiment is included in at least one embodiment of the present invention. Thus, the occurrence of the phrase "in an embodiment" at various locations throughout the specification does not necessarily refer to the same embodiment. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments. Furthermore, the term "comprising" does not exclude other elements or steps.

[0044] The present invention is illustrated with the aid of the figures which show an interposition ophthalmic implant which is intended to collect aqueous humor from the anterior chamber towards the suprachoroidal space and to promote the transfer of this aqueous humor between the sclera and the ciliary body to durably lower the intraocular pressure (IOP).

[0045] For reasons of clarity of this disclosure, the interposition ophthalmic implant may be referred to as “implant” hereinafter.

[0046] [Fig.l] represents an implant 20 deliberately simplified but in accordance with the invention presented.

[0047] The implant 20 comprises a uveocompatible body 22, i.e. made of at least one material which is known for its uveocompatibility properties. In other words, said at least one material is not likely to alter the overlying and underlying structures as a result of the body 22 coming into contact with these structures and their repeated movements over time.

[0048] The body 22 extends along a main axis A intended to be oriented along an anteroposterior direction.

[0049] The body 22 of the implant 20 has three dimensions in space: a thickness e, a length L and a width 1 which are perpendicular to the thickness e. The ratio between length L and width 1 may be less than, equal to or greater than 1. Preferably, this ratio is less than 1 so that the width of the body 22 is greater than its length. More generally, when the width and / or the length vary, the body 22 defines a maximum length taken along the main anteroposterior axis A between the anterior 24 and posterior 26 edges as well as a maximum width taken along an axis perpendicular to this main axis A. The maximum width is thus preferably equal to or greater than the maximum length.

[0050] For example, the implant may have the following dimensions (width, length, thickness) 4*5*0.1 mm, or 3*6*0.8 mm, or 6*3*0.6 mm.

[0051] The thickness e is preferably less than or equal to 4 mm, including the protrusion(s) 36.

[0052] The length L of the body is preferably less than or equal to 6 mm to conform to the anatomy of the eye without risking damaging it.

[0053] The body 22 of the implant 20 comprises two opposite edges, an anterior edge 24 and a posterior edge 26, which are spaced apart from each other along the length L of the body 22.

[0054] The anterior edge 24 is intended to be oriented facing or near the anterior chamber of an eye. The posterior edge 26 is disposed opposite the anterior edge 24 relative to the body 22, along an anteroposterior direction.

[0055] The body 22 further comprises lateral edges 28 and 30 extending on either side of the body 22 between the front 24 and rear 26 edges. The lateral edges 28 and 30 extend mainly along the length L of the body 22 and the front 24 and rear 26 edges extend along the width 1 of the body 22.

[0056] The body 22 comprises an upper surface 32 intended to face the sclera and a lower surface 34 intended to be in contact with the uveal tissue, in particular the ciliary body.

[0057] The lower surface 34 is smooth so as to provide the body 22 with very little resistance to movement with respect to the ocular tissues. The lower surface 34 is intended to be in contact with the ciliary body which is very fragile, in particular with respect to the sclera. Thus, a smooth surface in contact with such tissue makes it possible to limit the risks of irritation and damage to the ciliary body, in particular during the placement of the implant. The lower surface is therefore not rough or does not have any protrusions.

[0058] The body 22 further comprises one or more protrusions 36 extending from the upper surface 32 towards the outside of the body 22 to allow contact of the protrusion(s) 36 with the sclera. An “outward” extension of the protrusion(s) 36 is understood to mean that the protrusion(s) 36 protrude from the upper surface 32. The protrusion(s) 36 thus have a protrusion thickness H taken along an axis perpendicular to the upper surface 32.

[0059] The protrusions 36 can be of any shape or section.

[0060] The sclera and the ciliary muscle are deformable tissues. The thickness of the or 36 outgrowths is chosen to account for possible tissue deformations while ensuring that an empty volume is not obstructed by deformed tissues. This is particularly true for the ciliary muscle which can deform considerably and is likely to form herniations in any offered volume.

[0061] The addition of one or more protrusions 36 on the upper surface 32 makes it possible to separate the sclera from the ciliary body and also to separate the sclera from the body 22 of the implant 20, in particular from its upper surface 32. Thus, a significant portion of the sclera is separated from the ciliary body while being freed from contact with the implant. The protrusion 36 makes it possible to achieve a tenting effect which allows better absorption of the aqueous humor by the sclera and therefore a reduction in the intraocular pressure (IOP). A tenting effect is understood to mean the lifting of the tissues of the sclera by localized contact.

[0062] The protrusion(s) 36 are intended to separate the tissues while forming an implant-free volume between these tissues, an empty volume 121 (see [Fig.2]). As indicated above, a clinical trial conducted with a device intended to create a separation and an empty volume (in the sense that it is not filled by the material of the implant body) between the sclera and the ciliary body, without geometry intended to conduct aqueous humor in the anteroposterior direction, surprisingly showed better results on the reduction of IOP, and therefore on the circulation and drainage of aqueous humor. This trial clearly showed that the main difference in the reduction of IOP comes from the surface of scleral tissue available for aqueous absorption, and the volume created by the implant "empty of implant material" made available for aqueous circulation.

[0063] The sclera and the ciliary muscle are deformable tissues. The design of the implant must take into account possible deformations and ensure that the empty volume it is intended to create will not be filled with deformed tissues. This is particularly true for the ciliary muscle which can deform considerably and is likely to form hernias in any offered volume. However, it is considered for simplification that these hernias cannot have a height greater than half the width of their base, which is a design rule to be taken into account in the following.

[0064] Although less deformable, the same attention must be paid to the design of the face of the implant in contact with the sclera.

[0065] The implant is preferably formed from a single part in the sense that it is formed as a single, single-piece piece. The implant is therefore not an assembly of several pieces fixed together to form the body.

[0066] [Fig. 2] represents, in section, the implant 20 in functional position within an eye 110 of a patient.

[0067] This section of a part of the eye 110 represents the anterior chamber 112 which is arranged between the cornea 114 and the lens 116 delimited at its peripheral part by the iris 119. Behind the iris 119 is arranged the posterior chamber 120.

[0068] The sclera 122 is connected to the periphery of the cornea 114 via the limbus 124 (area of change in the radius of curvature between the sclera and the cornea). The sclera 122 covers the ciliary body 128 which is connected to the iris 119 and which includes the ciliary muscle 130 on which the sclera 122 rests.

[0069] The trabeculum 134 arranged between the cornea and the iris acts as a filter and is crossed by the aqueous humor which circulates in the anterior chamber 112.

[0070] Schlemm's canal 136 is located between the sclera and the cornea behind the trabeculum 134.

[0071] The different arrows Fl, F2, F3 and F4 illustrate the paths or routes taken by the aqueous humor: - Fl represents the conventional path or flow taken by the aqueous humor entering the anterior chamber 112; - F3 represents the conventional path or flow taken by the aqueous humor leaving the anterior chamber 112 through the trabeculum 134 and heading towards Schlemm's canal 136; - F4 represents the conventional physiological uveoscleral flow of aqueous humor exiting the anterior chamber 112.

[0072] The implant 20 has been interposed between the sclera 122 and the ciliary muscle 130 as described above. This implant 20 is installed near the root of the ciliary muscle 118 in order to exert its permanent spacing effect at the most appropriate location, while respecting the insertion of the ciliary muscle 130 to the scleral spur. The anterior edge 24 of the implant 20 can be arranged at a distance from the root of the ciliary muscle 118 or even in contact with it.

[0073] [Fig. 3] is a more detailed and enlarged view of the structure of the iridocomean angle without the implant. As shown in this figure, the scleral spur 132 on which the ciliary muscle 130 is inserted is located above the uveal portion 134a of the trabeculum 134.

[0074] The spacing produced at this location between the sclera and the ciliary body, by contact or not of the anterior edge 24 of the implant 20 with the root of the iris 119, makes it possible to permanently collect the aqueous humor as close as possible to the zone of physiological uveo-scleral flow (the spacing effect creates a zone of less resistance to the flow of aqueous humor). Such an implant 20 thus positioned provides a significant gain in increasing physiological uveo-scleral flow.

[0075] The physiological uveoscleral outflow is increased by an additional fraction of F4 flow through the posterior part of the trabecular meshwork (ciliary trabeculum), as shown in [Fig. 2] by the arrows F4' located above and below the implant. The flow of this additional fraction is achieved by the spacing effect of the implant between the sclera and the ciliary body, close to the root of the ciliary muscle 118, without damaging the latter.

[0076] Each protrusion 36 defines an upper contact surface 38 with the sclera. This upper contact surface 38 is formed by a distal portion of said protrusion 36 and has the function of being in contact with the sclera when the implant 20 is arranged between the sclera and the ciliary body.

[0077] As indicated above, the purpose of the protrusion(s) is to separate the sclera from the upper surface 32 of the implant 20. Several parameters, taken individually or in combination, make it possible to improve this separation of the sclera from the implant. These parameters are in particular the position, shape, distribution and number of the protrusion(s) 36, more particularly of the upper contact surface(s) 38.

[0078] Said upper contact surface 38 of the outgrowth or of each outgrowth may occupy in a unitary manner at most 50% of the upper surface 32 when the upper surface 32 is projected onto a top plane perpendicular to a normal to the upper surface 32. In other words, when the upper surface 32 is observed in a top view, each upper contact surface 38 occupies in a unitary manner at most 50% of the upper surface 32. This upper contact surface 38 may have any shape allowing separation of the sclera with the upper surface 32. For example, the upper contact surface 38, observed in this top view, may be one or more rectilinear or curved segments extending along a trajectory. The upper contact surface 38 may be continuous or discontinuous.

[0079] More preferably, said upper contact surface 38 of the protrusion or of each protrusion occupies in a unitary manner at most 50% of the upper surface 32 when the upper surface 32 is projected onto a top plane perpendicular to a normal to the upper surface 32.

[0080] Each protrusion 36 defines a protrusion height H taken along an axis perpendicular to the upper surface 32 and passing through said protrusion 36 (see [Fig.l]). Said protrusion height may be greater than or equal to 10 pm, preferably greater than or equal to 50 pm, more preferably greater than or equal to 100 pm. The term "protrusion height H" means the maximum protrusion height H.

[0081] Furthermore, said height of protrusion may be less than or equal to 2 mm, preferably less than or equal to 1 mm, more preferably less than or equal to 800 μm. Said height of protrusion may advantageously be between 100 and 500 μm.

[0082] The protrusion(s) 36 may extend mainly along an anteroposterior direction (i.e. along the main axis A) and / or along a per- pendicular to this anteroposterior direction.

[0083] The upper surface 32 includes an anterior portion disposed proximate the anterior edge 24 and a posterior portion disposed proximate the posterior edge 26. A medial portion may also be defined between the anterior and posterior portions. The protrusion(s) may be disposed only in the medial and / or posterior portions of the upper surface 32 so as to separate the sclera from the upper surface 32 without damaging the interconnected tissues at the root of the iris. The protrusion(s) may be disposed only in the posterior portion to achieve a good balance between reducing the contact area of the protrusion(s) with the sclera and separating the sclera from the upper surface 32.

[0084] The protrusion(s) 36 may extend along a path or main axis of extension when the upper surface 32 is projected onto a top plane perpendicular to a normal to the upper surface 32. The protrusion(s) 36 each have a longitudinal dimension along this path or main axis of extension and a transverse dimension along an axis perpendicular to this path or main axis of extension. The longitudinal and transverse dimensions are defined such that the transverse dimension is equal to or less than the longitudinal dimension. The transverse dimension may also be defined so as to be less than or equal to three times the protrusion height H. The transverse dimension may further be defined so as to be less than or equal to 1.5 mm.

[0085] When the body 22 comprises a plurality of protrusions 36, the plurality of upper contact surfaces 38 of the protrusions 36 jointly occupy at most 50% of the upper surface 32 when the upper surface 32 is projected onto a top plane perpendicular to a normal to the upper surface 32. In other words, when the upper surface 32 is observed in a top view, the sum of the upper contact surfaces 38 occupies at most 50% of the upper surface 32.

[0086] The lower surface 34 comprises at least one recess communicating with the upper surface 32 so as to allow the passage of a fluid from the lower surface 34 to the upper surface 32. This recess may be a through hole extending between the upper 32 and lower 34 surfaces. Alternatively, this recess may be a plurality of holes or empty spaces communicating with each other from the lower surface 34 to the upper surface 32. This recess may in particular be obtained by the use of a porous material.

[0087] This at least one recess occupies at least 5% of the lower surface 34 when the lower surface 34 is projected onto a bottom plane perpendicular to a normal to the lower surface 34. These recesses allow circulation of aqueous humor from the ciliary body to the sclera.

[0088] The dimensions of these recesses are chosen to limit the development of hernias of the ciliary body which would otherwise hinder the flow of aqueous humor by clogging the recesses.

[0089] To further limit the development of hernias, each recess may comprise a stop capable of blocking tissue penetrating into the recess. Each recess defines a recess extension axis between the lower 34 and upper 32 surfaces. This stop extends for example at least partly perpendicular to this recess extension axis. The stop preferably occupies at least 30% of the section of said recess when the lower surface 34 is projected onto a bottom plane perpendicular to a normal to the lower surface 34.

[0090] As visible in [Fig.4], the upper surface 32 may also comprise at least one recess. This recess may take the form of a groove 31 or a hollow relief extending over all or part of the upper surface 32. Said at least one recess may extend along an anteroposterior axis and / or along an axis transverse to this anteroposterior axis. This recess of the upper surface 32 generally has the function of promoting the flow of aqueous humor along the width and / or the length of the body 22 of the implant 20.

[0091] When the upper surface 32 comprises at least one recess, a recess bottom surface 33 is defined inside said at least one recess. A protrusion 36 within the meaning of the present invention extends from the upper surface 32 and not from a recess bottom surface 33.

[0092] Figures 5 to 11 show examples of embodiments of the implant 20 according to the invention.

[0093] With reference to [Fig. 5], the implant 50 has a concave anterior edge 54 and a protrusion 56 extending perpendicular to the anteroposterior main axis A. The protrusion 56 extends over the entire width of the body 52 of the implant 50. The body 52 has a width greater than its length. The section of the protrusion is square or rectangular.

[0094] With reference to [Fig.6], the implant 60 illustrated in side view is similar to the implant 50 of [Fig.4] with anterior 64 and posterior 66 edges as well as beveled or rounded walls of the protrusion 68.

[0095] With reference to [Fig.7], the implant 70 has a concave body 72 to conform to the anatomy of the eye. The body 72 has a width varying continuously between the anterior 74 and posterior 76 edges. A first protrusion 78 is disposed near the anterior edge 74 and a second protrusion 79 is disposed near the posterior edge 76.

[0096] [Fig.8] shows an implant 80 also comprising two protrusions 88. The body 82 has different widths, including a drop-out at the posterior edge 86.

[0097] [Fig.9] shows an implant 90 comprising a plurality of protrusions 98 extending perpendicular to the anteroposterior axis.

[0098] Figures 10 and 11 show implants 160 and 170 comprising a plurality of protrusions 168 and 178.

Claims

Claims

1. An ophthalmic implant (20, 50, 60, 70, 80, 90, 160, 170) for permanent interposition between the sclera and the uveal tissue comprising a uveocompatible implant body (22, 52, 72, 82) extending along a main axis (A) intended to be oriented along an anteroposterior direction, said implant body comprising an upper surface (32) intended to face the sclera and a lower surface (34) intended to be in contact with the uveal tissue, said implant body further comprising a first edge (24, 54, 64, 74) called anterior intended to be oriented towards the anterior chamber of an eye and a second edge (26, 66, 76, 86) called posterior opposite the anterior edge with respect to the body implant, characterized in that the lower surface is smooth and the implant body comprises one or more protrusions (36, 56, 68, 78, 79, 88, 98, 168,178) extending from the upper surface outwardly of the body to allow contact of the growth(s) with the sclera and to separate the sclera from the upper surface of the implant body.,

2. An interpositional ophthalmic implant according to claim 1, wherein the or each protrusion (36, 56, 68, 78, 79, 88, 98, 168, 178) defines a top scleral contact surface, said top contact surface of the or each protrusion occupying unitarily at most 50% of the top surface when the top surface is projected onto a top plane perpendicular to a normal to the top surface.

3. An ophthalmic interposition implant (20, 50, 60, 70, 80, 90, 160, 170) according to claim 1 or 2, wherein the or each protrusion (36, 56, 68, 78, 79, 88, 98, 168, 178) defines a protrusion height taken along an axis perpendicular to the upper surface and passing through said protrusion, said protrusion height being greater than or equal to 10 pm, preferably greater than or equal to 50 pm, more preferably greater than or equal to 100 pm.

4. An ophthalmic interposition implant (20, 50, 60, 70, 80, 90, 160, 170) according to any one of claims 1 to 3, wherein the or each protrusion (36, 56, 68, 78, 79, 88, 98, 168, 178) defines a protrusion height taken along an axis perpendicular to the upper surface and passing through said protrusion, said height of protrusion being less than or equal to 2 mm, preferably less than or equal to 1 mm, more preferably less than or equal to 800 μm.

5. An interposition ophthalmic implant according to one of the preceding claims, wherein said or one of the protrusions extends mainly along an anteroposterior direction extending between the first and second edges.

6. An ophthalmic interposition implant (20, 50, 60, 70, 80, 90, 160, 170) according to one of claims 1 to 4, wherein said protrusion or one of the protrusions (36, 56, 68, 78, 79, 88, 98, 168, 178) extends mainly along a direction perpendicular to the anteroposterior direction extending between the first and second edges.

7. An ophthalmic interposition implant (70, 80, 90, 160, 170) according to any preceding claim, wherein the upper surface comprises an anterior portion disposed proximate the first edge and a posterior portion disposed proximate the second edge, said or one of the protrusions being disposed in said posterior portion.

8. An ophthalmic interposition implant (70, 80, 90, 160, 170) according to any preceding claim, in combination with claim 2, wherein the implant body comprises a plurality of protrusions extending from the upper surface outwardly of the body and wherein the upper contact surfaces of the plurality of protrusions together occupy at most 50% of the upper surface when the upper surface is projected onto a top plane perpendicular to a normal to the upper surface.

9. An ophthalmic interposition implant (70, 80, 90, 160, 170) according to claim 8, wherein the plurality of protrusions comprises at least two protrusions disposed between the first and second edges.

10. An ophthalmic interposition implant (170) according to any preceding claim, wherein the lower surface comprises at least one recess communicating with the upper surface so as to allow passage of fluid from the lower surface to the upper surface.

11. The ophthalmic interposition implant (170) of claim 10, wherein said at least one recess occupies at least 5% of the bottom surface when the bottom surface is projected onto a bottom plane perpendicular to a normal to the bottom surface.

12. An ophthalmic interposition implant (50, 80, 170) according to any preceding claim, wherein the implant body defines a maximum length taken along an anteroposterior axis extending between the first and second edges and a maximum width taken along an axis perpendicular to the anteroposterior axis, the maximum width of the implant body being equal to or greater than the maximum length of the implant body.

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