OPHTHALMOLOGICAL INTERPOSITION IMPLANT HAVING ONE OR MORE PROGRESSIONS ON ITS UPPER SURFACE

Abstract

The invention relates to a permanent interposition ophthalmic implant (20) between the sclera and the uveal tissue comprising a uveocompatible implant body (22) extending along a principal axis (A) intended to be oriented along an anteroposterior direction, said implant body comprising a superior surface (32) intended to face the sclera and a inferior surface (34) intended to be in contact with the uveal tissue, said implant body further comprising a first edge (24) called anterior intended to be oriented towards the anterior chamber of an eye and a second edge (26) called posterior opposite to 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 projections (36) extending from the upper surface outwards from the body to allow contact of the projection(s) with the sclera and to separate the sclera from the upper surface of the implant body. Figure for the abstract: Figure 1,

Description

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

[0001] The present invention relates to an interpositional ophthalmic implant for collecting aqueous humor from the anterior chamber into the supraciliary and suprachoroidal spaces in order to durably 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 outflow through the trabecular meshwork of the scleral-comeoscleral tract via Schlemm's canal and its drainage channels to the aqueous veins and the general circulation. A fraction of this outflow, 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 uveoscleral outflow. The longitudinal fibers of the ciliary muscle, particularly during accommodation, play a role in tensioning the trabecular meshwork, which facilitates the uveoscleral outflow of aqueous humor. The uveoscleral flow also occurs through these longitudinal fibers of the ciliary muscle.

[0003] In glaucoma, the outflow of aqueous humor is reduced at the level of the scleral trabecular meshwork, which in most 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 by the ciliary body (cyclodialysis) or increasing the outflow of aqueous humor by diverting it. This diverting is performed in different ways: - by directly connecting the anterior chamber and the suprachoroidal space (cyclodilysis 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 uveoscleral outflow in the surgical area.Furthermore, postoperative fibrosis extends beyond this area. It is also known that the portion of the implant located in the anterior chamber can, even intermittently, affect the corneal endothelium, thereby leading to a significant risk of progressive corneal edema. - by incising, from the anterior chamber, the trabecular meshwork up to the canal of Schlemm's procedure bypasses the trabecular obstruction. This intervention can be complemented by the placement of an open stent in the canal, directed towards the anterior chamber, to maintain permanent direct access of aqueous humor to the canal. Here too, the results are often partial and temporary, and do not eliminate the need for continued or resumed medical treatment.

[0004] Filtering surgery remains a standard treatment and aims to divert the aqueous humor beneath the conjunctiva to achieve the necessary pressure reduction. It can create a permanent, full-thickness opening in the trabecular meshwork under a scleral flap: trabeculectomy. One variant leaves the internal part of the trabecular meshwork in place; this is called non-penetrating trabecular meshwork surgery (deep sclerectomy, viscocanalostomy).

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

[0006] It is also known from the state of the art that there have been numerous attempts to normalize IOP using implants, either in conjunction with the surgical procedures mentioned above or used alone. However, these implants all distort the anatomy of the eye to some extent and / or divert / modify the natural drainage pathways.

[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 root of the iris and the supraciliary space. This is evident from their design: - when they are in 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 that collects the aqueous humor in the anterior chamber and drains it into the suprachoroidal space.

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

[0009] Whether or not the root of the iris is incised to access the anterior chamber, these implants conceive of aqueous circulation in the supraciliary space as a significant flow that can be collected and then channeled into a canal. 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 studies show that The aqueous flow in this area is rather microscopic and diffuse. Furthermore, all these implants aim to conduct the aqueous humor from the ciliary body to the choroidal space and bypass the sclera's absorptive capacity. Plate-shaped implants are generally solid and present a continuous or slightly concave surface to, or in contact with, the sclera.

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

[0011] A clinical trial conducted with a device designed to create 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 intended to conduct aqueous humor in an anteroposterior direction, surprisingly showed better results in reducing IOP, and therefore in improving the circulation and drainage of aqueous humor. This trial clearly demonstrated that the main difference in IOP reduction stems from the surface area of ​​scleral tissue available for aqueous absorption, and from the volume created by the "implant-free" implant made available for aqueous circulation.

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

[0013] To this end, the invention proposes a permanent interpositional ophthalmic implant between the sclera and the uveal tissue, comprising a uveo-compatible implant body extending along a principal axis intended to be oriented in an anteroposterior direction, said implant body comprising a superior surface intended to face the sclera and a inferior surface intended to be in contact with the uveal tissue, said implant body further comprising a first edge, referred to as the anterior edge, intended to be oriented towards the anterior chamber of an eye, and a second edge, referred to as the posterior edge, opposite the anterior edge with respect to the implant body, characterized in that the inferior surface is smooth and the implant body comprises one or more protrusions extending from the superior surface outwards from the body to allow contact of the protrusion(s) with the sclera and to separate the sclera from the superior surface of the implant body.

[0014] Adding a projection to the superior surface allows the sclera to be separated from the ciliary body and also from the body of the implant, particularly its superior surface. Thus, a significant portion of the sclera is separated from the ciliary body while being freed from contact with the implant. The projection creates a tenting effect, which allows for better absorption of aqueous humor by the sclera and therefore a reduction in intraocular pressure. (PIO). The tent effect refers to the lifting of scleral tissues by localized contact.

[0015] A clinical trial conducted with a device designed to create a separation and a void volume (in the sense that it is not filled by the implant body material) between the sclera and the ciliary body, without geometry intended to conduct aqueous humor in an anteroposterior direction, surprisingly showed better results in reducing IOP, and therefore in improving the circulation and drainage of aqueous humor. This trial clearly demonstrated that the main difference in IOP reduction stems from the surface area of ​​scleral tissue available for aqueous absorption and the volume created by the implant, which is "empty of implant material" and thus 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 the aqueous humor.

[0017] Furthermore, having a smooth underside helps to limit the risk of irritation and damage to the ciliary body, particularly during implant placement. The underside is therefore neither rough nor does it have any protrusions.

[0018] According to one embodiment of the interpositional ophthalmic implant, the protrusion or each protrusion defines a superior contact surface with the sclera, said superior contact surface of the protrusion or each protrusion occupying at most 50% of the superior surface when the superior surface is projected onto a top plane perpendicular to a normal to the superior surface.

[0019] According to one embodiment of the interpositional ophthalmic implant, the protrusion or each protrusion 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.

[0020] According to one embodiment of the interpositional ophthalmic implant, the protrusion or each protrusion defines a protrusion height taken along an axis perpendicular to the upper surface and passing through said protrusion, said protrusion 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 pm.

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

[0022] According to one embodiment of the interpositional 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 interpositional 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 interpositional ophthalmic implant, the implant body comprises a plurality of protrusions extending from the upper surface outwards from the body.

[0025] According to one embodiment of the interpositional 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 interpositional ophthalmic implant, the plurality of protrusions comprises at least two protrusions arranged between the first and second edges.

[0027] According to one embodiment of the interpositional ophthalmic implant, the lower surface includes at least one opening 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 interpositional ophthalmic implant, said at least one recess occupies at least 5% of the lower surface when the lower surface is projected onto a plane below perpendicular to a normal to the lower surface.

[0029] According to one embodiment of the interpositional ophthalmic implant, 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. Brief description of the figures

[0030] The following description, with reference to the accompanying drawings, given by way of non-limiting examples, will clearly explain what the invention consists of and how it can be implemented. In the accompanying figures:

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

[0032] [Fig.2] Fig.2 represents a schematic view of the situation in an eye human of a general simplified possible 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 the [Fig.2],

[0034] [Fig.4] Fig.4 represents a schematic perspective view of the implant of the [Fig. 1] with the implant body having a groove,

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

[0036] [Fig.6] Fig.6 represents a schematic side view of another example of a Implant shaping with anterior and posterior edges as well as beveled and / or rounded protrusion walls,

[0037] [Fig.7] Fig.7 represents a schematic perspective view of another example the design of 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 implant fabrication 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 the fabrication of 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 outgrowths having geometries different from each other,

[0041] [Fig. 11] The [Fig. 11] represents a schematic perspective view of another example of an 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 over the upper surface of the body, a plurality of protrusions extending from the anterior edge to the posterior edge; Description of method(s) of implementation

[0042] The concept of the invention is described more fully below with reference to the accompanying drawings, in which embodiments of the concept of the invention are shown. In the drawings, the size and relative sizes of the elements may be exaggerated for clarity. Similar numbers refer to similar elements in all drawings. However, this concept of the invention can be implemented in many different forms and should not be interpreted as being limited to the embodiments set forth herein. Instead, these embodiments are proposed so that this description is complete, and communicate the scope of the concept of the invention 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 relation to an embodiment is included in at least one embodiment of the present invention. Thus, the appearance of the phrase "in an embodiment" in various places 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. Moreover, the term "including" does not exclude other elements or steps.

[0044] The present invention is illustrated by means of the figures which show an interpositional ophthalmic implant which is intended to collect aqueous humor from the anterior chamber to the suprachoroidal space and to promote the transfer of this aqueous humor between the sclera and the ciliary body in order to permanently lower intraocular pressure (IOP).

[0045] For the sake of clarity in this presentation, the interpositional ophthalmic implant may be referred to as the "implant" hereafter.

[0046] Fig. 1 represents a deliberately simplified implant 20, but one that conforms to the invention presented.

[0047] The implant 20 comprises a uveocompatible body 22, i.e., made of at least one material known for its uveocompatible 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 principal 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 the length L and the width 1 can 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 length vary, the body 22 defines a maximum length measured along the anteroposterior principal axis A between the anterior edge 24 and the posterior edge 26, as well as a maximum width measured along an axis perpendicular to this principal axis A. The maximum width is thus preferably equal to or greater than the maximum length.

[0050] By way of 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 4mm, including the protrusion(s) 36.

[0052] The length L of the body is preferably less than or equal to 6mm to conform to the anatomy of the eye without risk of 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 separated from each other along the length L of the body 22.

[0054] The anterior edge 24 is intended to be oriented towards or near the anterior chamber of an eye. The posterior edge 26 is arranged opposite the anterior edge 24 with respect 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 anterior edges 24 and posterior edges 26. The lateral edges 28 and 30 extend mainly along the length L of the body 22 and the anterior edges 24 and posterior edges 26 extend along the width 1 of the body 22.

[0056] The body 22 comprises an upper surface 32 intended to face the sclera and an 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 low resistance to movement against the ocular tissues. The lower surface 34 is intended to be in contact with the ciliary body, which is very fragile, particularly with respect to the sclera. Thus, a smooth surface in contact with such tissue helps to limit the risks of irritation and damage to the ciliary body, especially during implantation. The lower surface is therefore not rough or protrusions.

[0058] The body 22 further comprises one or more projections 36 extending from the upper surface 32 outwards from the body 22 to allow contact of the projection(s) 36 with the sclera. An "outward" extension of the projection(s) 36 means that the projection(s) 36 protrude from the upper surface 32. The projection(s) 36 thus have a thickness H measured along an axis perpendicular to the upper surface 32.

[0059] The outgrowths 36 can be of any shape or any cross-section.

[0060] The sclera and the ciliary muscle are deformable tissues. The thickness of the or The 36-point projection is chosen to account for possible tissue deformations while ensuring that an empty volume is not obstructed by deformed tissue. This is particularly true for the ciliary muscle, which can deform considerably and is prone to herniation in any available volume.

[0061] The addition of one or more projections 36 on the upper surface 32 allows the sclera to be separated from the ciliary body and also from the body 22 of the implant 20, in particular 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 projection 36 creates a tenting effect, which allows for better absorption of aqueous humor by the sclera and therefore a reduction in intraocular pressure (IOP). A tenting effect is defined as the lifting of scleral tissues through 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 designed to create 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 intended to conduct aqueous humor in an anteroposterior direction, surprisingly showed better results in reducing IOP, and therefore in improving the circulation and drainage of aqueous humor. This trial clearly demonstrated that the main difference in IOP reduction arises from the surface area of ​​scleral tissue available for aqueous absorption, and from the volume created by the implant, which is "empty of implant material" and thus 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 tissue. This is particularly true for the ciliary muscle, which can deform considerably and is prone to herniation in any available volume. However, for the sake of simplicity, it is assumed that these herniations cannot have a height greater than half the width of their base, which constitutes a design rule to be considered 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 from a single, monolithic piece. The implant is therefore not an assembly of several parts fixed together to form the body.

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

[0067] This section of part of the eye 110 represents the anterior chamber 112 which is located between the cornea 114 and the lens 116 delimited at its peripheral part by the iris 119. Behind the iris 119 is located 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 located between the cornea and the iris acts as a filter and is traversed 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 exiting the anterior chamber 112 through the trabeculum 134 and heading towards Schlemm's canal 136; - F4 represents the conventional physiological uveoscleral outflow of aqueous humor from the anterior chamber 112.

[0072] The implant 20 was 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 retraction 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 positioned away from the root of the ciliary muscle 118 or even in contact with it.

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

[0074] The gap created at this point between the sclera and the ciliary body, whether or not the anterior edge 24 of the implant 20 is in contact with the root of the iris 119, allows for the permanent collection of aqueous humor as close as possible to the area of ​​physiological uveoscleral outflow (the gap creates an area of ​​less resistance to the flow of aqueous humor). Such an implant 20, positioned in this way, provides a significant increase in physiological uveoscleral outflow.

[0075] Physiological uveoscleral outflow is increased by an additional fraction of F4 outflow through the posterior part of the trabeculum (ciliary trabeculum), as shown in [Fig. 2] by the arrows F4' located above and below the implant. The outflow of this additional fraction is achieved through the separating effect of the implant between the sclera and the ciliary body, near the root of the ciliary muscle 118, without however 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 is intended to be in contact with the sclera when the implant 20 is positioned between the sclera and the ciliary body.

[0077] As indicated above, the purpose of the protrusion(s) is / are to separate the sclera from the upper surface 32 of the implant 20. Several parameters, taken individually or in combination, allow for improved separation of the sclera from the implant. These parameters include the position, shape, distribution, and number of the protrusion(s) 36, and more specifically, the upper contact surface(s) 38.

[0078] The upper contact surface 38 of the protrusion or of each protrusion may 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 viewed from above, each upper contact surface 38 occupies at most 50% of the upper surface 32. This upper contact surface 38 may have any shape that allows separation of the sclera from the upper surface 32. By way of example, the upper contact surface 38, as seen in this top view, may be one or more straight or curved segments extending along a path. The upper contact surface 38 may be continuous or discontinuous.

[0079] Even more preferably, said upper contact surface 38 of the protrusion or of each protrusion occupies 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 measured along an axis perpendicular to the upper surface 32 and passing through said protrusion 36 (see [Fig. 1]). This protrusion height may be greater than or equal to 10 pm, preferably greater than or equal to 50 pm, and even more preferably greater than or equal to 100 pm. The term "protrusion height H" refers to the maximum protrusion height H.

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

[0082] The outgrowth(s) 36 may extend mainly along an anteroposterior direction (i.e., along the principal axis A) and / or along a per- pendulum in this anteroposterior direction.

[0083] The upper surface 32 comprises an anterior portion located near the anterior edge 24 and a posterior portion located near the posterior edge 26. A median portion may also be defined between the anterior and posterior portions. The projection(s) may be located only in the median and / or posterior portions of the upper surface 32 so as to separate the sclera from the upper surface 32 without damaging the tissues connected to each other at the root of the iris. The projection(s) may be located only in the posterior portion to achieve a good balance between reducing the contact area of ​​the projection(s) with the sclera and separating the sclera from the upper surface 32.

[0084] The protrusion(s) 36 may extend along a trajectory or principal axis of extension when the upper surface 32 is projected onto a top plane perpendicular to a normal to the upper surface 32. Each protrusion(s) 36 has a longitudinal dimension along this trajectory or principal axis of extension and a transverse dimension along an axis perpendicular to this trajectory or principal 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 to be less than or equal to three times the height H of the protrusion. The transverse dimension may further be defined 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 viewed from above, the sum of the upper contact surfaces 38 occupies at most 50% of the upper surface 32.

[0086] The lower surface 34 includes at least one opening 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 opening may be a through hole extending between the upper surface 32 and the lower surface 34. Alternatively, this opening may be a plurality of holes or voids communicating with each other from the lower surface 34 to the upper surface 32. This opening may in particular be obtained by using 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 plane below perpendicular to a normal to the lower surface 34. These recesses allow the aqueous humor to circulate 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 impede the flow of aqueous humor by clogging the recesses.

[0089] To further limit the development of hernias, each recess may include a stop adapted to prevent tissue from penetrating the recess. Each recess defines a recess extension axis between the lower surface 34 and the upper surface 32. This stop extends, for example, at least partially perpendicular to this recess extension axis. The stop preferably occupies at least 30% of the cross-section of said recess when the lower surface 34 is projected onto a plane below perpendicular to a normal to the lower surface 34.

[0090] As shown in [Fig. 4], the upper surface 32 may also include at least one recess. This recess may be in the form of a groove 31 or a concave relief extending over all or part of the upper surface 32. This at least one recess may extend along an anteroposterior axis and / or along an axis transverse to this anteroposterior axis. The function of this recess in the upper surface 32 is generally to facilitate the flow of aqueous humor along the width and / or length of the body 22 of the implant 20.

[0091] When the upper surface 32 includes at least one recess, a recess bottom surface 33 is defined within said at least one recess. A projection 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 implant 20 according to the invention.

[0093] With reference to [Fig. 5], the implant 50 has a concave anterior edge 54 and a projection 56 extending perpendicularly to the anteroposterior principal axis A. The projection 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 cross-section of the projection is square or rectangular.

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

[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 that varies continuously between the anterior 74 and posterior 76 edges. A first protrusion 78 is located near the anterior edge 74 and a second protrusion 79 is located 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 step at the posterior edge 86.

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

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

Claims

Claims

1. Ophthalmological 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 ophthalmic interposition implant according to claim 1, wherein the or each protrusion (36, 56, 68, 78, 79, 88, 98, 168, 178) defines a top surface for contact with the sclera, said top surface for contact of the or each protrusion occupying in a unitary manner 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 pm.

5. An ophthalmic interposition 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. The ophthalmic interposition implant (70, 80, 90, 160, 170) of 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. An ophthalmic interposition implant (170) according to 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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