Ophthalmological interposition implant having one or more projections on its upper surface

Abstract

The invention relates to an ophthalmological implant (20) for permanent interposition between the sclera and the uveal tissue, the implant comprising a uveocompatible implant body (22) extending along a main axis (A) intended to be oriented in an anteroposterior direction, the 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, the implant body further comprising a first edge (24), referred to as the anterior edge, intended to be oriented towards the anterior chamber of an eye, and a second edge (26), referred to as the posterior edge, opposite the anterior edge with respect to the implant body, characterised in that the lower surface is smooth and the implant body comprises one or more projections (36) extending from the upper surface towards the outside of the body in order to allow the one or more projections to make contact with the sclera and to separate the sclera from the upper surface of the body of the implant.

Description

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 interpositional ophthalmic implant intended to collect aqueous humor from the anterior chamber to the supra-ciliary and supra-choroidal space in order to permanently 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 corneoscleral sclera via Schlemm's canal and its drainage pathways 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 known as 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. It is also through these longitudinal fibers of the ciliary muscle that the uveoscleral flow occurs.

[0003] In glaucoma, the outflow of aqueous humor is reduced at the corneoscleral 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 disinsertion The insertion of the ciliary muscle to the scleral spur in 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, contact the corneal endothelium, thus leading to a significant risk of progressive corneal edema. This can be achieved by incising the trabecular meshwork from the anterior chamber to Schlemm's canal to bypass the trabecular obstruction. This procedure can be supplemented by the placement of an open stent in the canal, directed towards the anterior chamber, to maintain continuous 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 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: a trabeculectomy. One variation leaves the inner 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 lifted) or, conversely, excessive filtration which may be related to the intraoperative use of mitomycin C.

[0006] Furthermore, it is well known that there have been numerous attempts to normalize IOP using implants, either in conjunction with the surgical procedures mentioned earlier or used alone. However, these implants all distort the anatomy of the eye to varying degrees 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 in their design: - when they are plaque-shaped, they tend to force the circulation of aqueous humor by means of grooves, undulations or oriented internal channels 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 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. However, in normal anatomy, the sclera and ciliary body are in direct contact, and there is no vessel between them. Some preclinical and clinical studies show that 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 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 a void volume (in the sense that it is not filled by the device material) between the sclera and the ciliary body, without any geometry intended to guide aqueous humor in an anteroposterior direction, surprisingly showed better results in reducing intraocular pressure (IOP), and therefore in improving aqueous humor circulation and drainage. 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 "without implant material" and thus made available for aqueous circulation.

[0012] Therefore, there is 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 an ophthalmic implant for permanent interposition between the sclera and the uveal tissue, comprising a uveocompatible implant body extending along a principal axis intended to be oriented along 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 called anterior intended to be oriented towards the anterior chamber of an eye and a second edge called posterior opposite to 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 for separation of the sclera from the ciliary body and also from the implant body, 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 (IOP). A tenting effect refers to the lifting of scleral tissues through 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 any geometry intended to guide aqueous humor in an anteroposterior direction, surprisingly showed better results in reducing intraocular pressure (IOP), and therefore in improving aqueous humor circulation and drainage. 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, increasing 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 minimize the risk of irritation and damage to the ciliary body, particularly during implant placement. The underside is therefore not rough or protrusions.

[0018] The lower surface may have recesses or holes through the implant body (example in Figure 11) without compromising the smoothness of the lower surface. In the case of one or more recesses or holes, the lower surface must be smooth around them. "Smooth" means that the lower surface does not have any protrusions around the recesses or holes. A protrusion has a dimension along an axis perpendicular to the principal axis corresponding to the implant thickness greater than or equal to 10 µm, preferably greater than or equal to 50 µm, and even more preferably greater than or equal to 100 µm.

[0019] 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.

[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 greater than or equal to 10 pm, preferably greater than or equal to 50 pm, more preferably greater than or equal to 100 pm.

[0021] 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, even more preferably less than or equal to 800 pm.

[0022] 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.

[0023] 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.

[0024] 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.

[0025] 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.

[0026] 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.

[0027] According to one embodiment of the interpositional ophthalmic implant, the plurality of protrusions includes at least two protrusions arranged between the first and second edges.

[0028] 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.

[0029] 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.

[0030] 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.

[0031] According to another aspect, taken in combination or not with the characteristics described above, the invention proposes a permanent interposition ophthalmic implant between the sclera and the uveal tissue comprising a uveocompatible implant body extending along a principal axis intended to be oriented along 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 called anterior intended to be oriented towards the anterior chamber of an eye and a second edge called posterior opposite to the anterior edge with respect to the implant body, characterized in that it further comprises an electronic module configured to determine at least one piece of information about the user,a state of the ophthalmic implant or information external to the implant and an electrical battery to power the electronic module.

[0032] The electronic module allows the implant to communicate by acquiring and transmitting information about its environment. The implant thus performs an intelligent function (information acquisition) while also promoting the flow and diffusion of aqueous humor to lower intraocular pressure.

[0033] The electronic module thus allows the implant to communicate while fulfilling its main function of lowering intraocular pressure and hypotensive.

[0034] The electronic module may include one or more of the following: a sensor, a storage memory, a communication device configured to communicate information with a device external to the implant, and a controller configured to communicate with one or more components of the electronic module. The communication device is preferably configured to receive and / or transmit information.

[0035] User information can be one or more of the following: temperature, humidity level, and intraocular pressure value.

[0036] Information about the user can, for example, be determined using a sensor placed within the ophthalmic implant. Measurements from this implant are preferably stored on internal implant memory or transmitted to an external device.

[0037] Information about the status of the implant can be one or more of the following: a battery charge level and a position of the implant between the sclera and the ciliary body.

[0038] Information about the implant's state can be determined through communication between an electronic component of the electronic module

[0039] External information can be one or more of the following: an instruction to activate or deactivate the electronic module, an instruction to take information or a measurement from a sensor, and an instruction to transfer information from the implant to an external device.

[0040] According to one embodiment, taken in combination or not with the characteristics described above, the implant is configured to change at least one of its attributes: at least one of its longitudinal, transverse and thickness dimensions, its anteroposterior position between the sclera and the ciliary body.

[0041] The modification of one of its attributes is preferably activated by means of the electronic module within the implant. This activation can be automatic, i.e., programmed into the internal memory of its controller, or manual, via the transmission of a command from an external device to a communication device of the electronic module. This command could, for example, be a command to change the implant thickness, sent by a surgeon after the implant has been placed in the patient.

[0042] According to another aspect of the invention, taken in combination or not with the features described above, the implant is configured to deliver an active ingredient to the user when it is positioned between the sclera and the ciliary body. The delivery or transfer of this active ingredient can be "passive," i.e., solely by contact between the user's tissues and the implant, or "active." i.e. an electronic module is configured to be activated to deliver the active ingredient. Brief description of the figures

[0043] The following description, with reference to the accompanying drawings, given by way of non-limiting examples, will clearly explain the nature of the invention and how it can be implemented. Regarding the accompanying figures:

[0044] [fig. 1] Figure 1 represents a schematic perspective view of an implant comprising an outgrowth projecting from a superior surface of the implant body,

[0045] [fig. 2] Figure 2 represents a schematic view in a human eye of a possible simplified general shape of an implant according to the invention interposed between the sclera and the ciliary body.

[0046] [Fig. 3] Figure 3 shows a more detailed and enlarged view of the structure of the iridocorneal angle without the implant shown in Figure 2.

[0047] [fig. 4] Figure 4 represents a schematic perspective view of the implant in Figure 1 with the implant body having a groove,

[0048] [fig. 5] Figure 5 represents a schematic perspective view of an example of an implant embodiment including an outgrowth extending transversely to the anteroposterior direction of the implant,

[0049] [fig. 6] Figure 6 shows a schematic side view of another example of implant embodiment with anterior and posterior edges as well as beveled and / or rounded protrusion walls,

[0050] [fig. 7] Figure 7 represents a schematic perspective view of another example of the implant embodiment comprising a plurality of protrusions and a body curved around an axis transverse to the anteroposterior direction of the implant,

[0051] [fig. 8] Figure 8 represents a schematic perspective view of another example of implant embodiment comprising anterior and posterior edges offset in the anteroposterior direction of the implant,

[0052] [fig. 9] Figure 9 represents a schematic perspective view of another example of implant embodiment comprising a plurality of protrusions having convex or rounded walls,

[0053] [fig. 10] Figure 10 represents a schematic perspective view of another example of the implant embodiment comprising outgrowths having geometries different from each other,

[0054] [fig. 11] Figure 11 represents a schematic perspective view of another example of implant embodiment comprising through recesses extending between the lower and upper surfaces of the implant body, 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;

[0055] [fig. 12] Figure 12 represents a permanent interposition ophthalmic implant between the sclera and the uveal tissue comprising an electronic module allowing communication between the implant and a third organ. Description of method(s) of implementation

[0056] 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 the drawings. However, this concept of the invention can be implemented in many different forms and should not be construed as being limited to the embodiments set forth herein. Rather, these embodiments are offered so as to make this description complete and to communicate the scope of the concept of the invention to those skilled in the art.

[0057] 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.

[0058] 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 to permanently lower intraocular pressure (IOP).

[0059] For the sake of clarity in this presentation, the interpositional ophthalmic implant may be referred to as the "implant" hereafter.

[0060] Figure 1 represents a deliberately simplified implant 20, but one that conforms to the invention presented.

[0061] 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.

[0062] The body 22 extends along a principal axis A intended to be oriented along an anteroposterior direction.

[0063] The body 22 of the implant 20 has three dimensions in space: a thickness e, a length L, and a width I, all perpendicular to the thickness e. The ratio between length L and width I 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.

[0064] As an example, the implant may have dimensions (width, length, thickness) of 4*5*0.1 mm, or 3*6*0.8 mm, or 6*3*0.6 mm.

[0065] The thickness e is preferably less than or equal to 4mm, including the protrusion(s) 36.

[0066] The body length L is preferably less than or equal to 6mm to conform to the anatomy of the eye without risking damage.

[0067] The body 22 of the implant 20 comprises two opposing edges, an anterior edge 24 and a posterior edge 26, which are separated from each other along the length L of the body 22.

[0068] The anterior border 24 is intended to be oriented towards or near the anterior chamber of an eye. The posterior border 26 is positioned opposite the anterior border 24 with respect to the body 22, along an anteroposterior direction.

[0069] The body 22 also includes 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 I of the body 22.

[0070] The body 22 comprises a superior surface 32 intended to face the sclera and a inferior surface 34 intended to be in contact with the uveal tissue, in particular the ciliary body.

[0071] The lower surface 34 is smooth to provide the body 22 with very low resistance to movement against the ocular tissues. The lower surface 34 is designed to be in contact with the ciliary body, which is very fragile, particularly in relation to the sclera. Thus, a smooth surface in contact with such tissue helps to limit the risk of irritation and damage to the ciliary body, especially during implant placement. The lower surface is therefore not rough or protrusions.

[0072] The body 22 also includes one or more projections 36 extending outwards from the upper surface 32 of 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.

[0073] The 36 outgrowths can be of any shape or cross-section.

[0074] The sclera and ciliary muscle are deformable tissues. The thickness of the outgrowth(s) 36 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 susceptible to forming hernias in any volume offered.

[0075] The addition of one or more projections 36 on the superior surface 32 allows the sclera to be separated from the ciliary body and also from the body 22 of the implant 20, particularly its superior 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 (P10). A tenting effect is defined as the lifting of scleral tissues through localized contact.

[0076] The 36 outgrowths are designed to separate the tissues while creating an implant-free volume between them, a void volume 121 (see Figure 2). As mentioned above, a clinical trial with a device designed to create a separation and a void volume (in the sense that it is not filled with 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 aqueous humor circulation and drainage. 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 available for aqueous circulation.

[0077] The sclera and ciliary muscle are deformable tissues. The implant design must account for potential deformations and ensure that the empty volume it is intended to create will not be filled with deformed tissue. This is especially 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 exceed half the width of their base in height, which is a design rule to be considered in the following sections.

[0078] Although less deformable, the same attention must be paid to the design of the face of the implant in contact with the sclera.

[0079] The implant is preferably formed from a single part, meaning it is a single, monolithic piece. Therefore, the implant is not an assembly of several parts fixed together to form the body.

[0080] Figure 2 shows, in cross-section, the implant 20 in functional position within an eye 1 10 of a patient.

[0081] This section of part of the eye 1 10 represents the anterior chamber 1 12 which is located between the cornea 114 and the lens 1 16 delimited at its peripheral part by the iris 1 19. Behind the iris 1 19 is located the posterior chamber 120.

[0082] The sclera 122 is connected to the periphery of the cornea 114 via the limbus 124 (the area where the radius of curvature changes between the sclera and the cornea). The sclera 122 covers the ciliary body 128, which is connected to the iris 119 and includes the ciliary muscle 130, against which the sclera 122 rests.

[0083] 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 1 12.

[0084] Schlemm's canal 136 is located between the sclera and the cornea behind the trabeculum 134.

[0085] The different arrows F1, F2, F3 and F4 illustrate the paths or routes taken by the aqueous humor: - F1 represents the conventional path or flow taken by the aqueous humor entering the anterior chamber 1 12; F3 represents the conventional path or flow taken by the aqueous humor exiting the anterior chamber 1 12 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 1 12.

[0086] Implant 20 was interposed between the sclera 122 and the ciliary muscle 130 as described above. This implant 20 is positioned 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 implant 20 can be positioned away from the root of the ciliary muscle 118 or in contact with it.

[0087] Figure 3 is a more detailed and enlarged view of the structure of the iridocorneal 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 part 134a of the trabeculum 134.

[0088] 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 ​​least resistance to the flow of aqueous humor). Such an implant 20, positioned in this way, provides a significant increase in physiological uveoscleral outflow.

[0089] Physiological uveoscleral outflow is increased by an additional fraction of F4 outflow through the posterior part of the trabeculum (ciliary trabeculum), as represented in Figure 2 by the F4' arrows located above and below the implant. This additional fraction of outflow is achieved through the implant's spreading effect between the sclera and the ciliary body, near the root of the ciliary muscle 118, without damaging the latter.

[0090] Each protrusion 36 defines a superior contact surface 38 with the sclera. This superior 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.

[0091] As mentioned above, the purpose of the projection(s) is / are to separate the sclera from the upper surface 32 of the implant 20. Several parameters, taken individually or in combination, can improve this separation of the sclera from the implant. These parameters include the position, shape, distribution, and number of the projection(s) 36, particularly those of the upper contact surface(s) 38.

[0092] The upper contact surface 38 of the protrusion or 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. As an example, the upper contact surface 38, observed in this top view, can be one or more straight or curved segments extending along a path. The upper contact surface 38 can be continuous or discontinuous.

[0093] 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.

[0094] 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 Figure 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.

[0095] Furthermore, the height of said protrusion 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. The height of said protrusion may advantageously be between 100 and 500 µm.

[0096] The outgrowth(s) 36 may extend mainly along an anteroposterior direction (i.e. along the main axis A) and / or along a direction perpendicular to this anteroposterior direction.

[0097] The superior surface 32 comprises an anterior portion located near the anterior margin 24 and a posterior portion located near the posterior margin 26. A median portion may also be defined between the anterior and posterior portions. The projection(s) may be located solely in the median and / or posterior portions of the superior surface 32 so as to separate the sclera from the superior surface 32 without damaging the tissues connected to each other at the root of the iris. The projection(s) may be located solely 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 superior surface 32.

[0098] The outgrowth(s) 36 can 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. The protrusion(s) 36 each have 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 so as to be less than or equal to three times the height H of the protrusion. The transverse dimension may further be defined so as to be less than or equal to 1.5 mm.

[0099] 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. [000100] The lower surface 34 includes 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 surface 32 and the lower surface 34. Alternatively, this recess may be a plurality of holes or voids communicating with each other from the lower surface 34 to the upper surface 32. This recess may in particular be obtained by using a porous material. [000101] 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. [000102] 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. [000103] 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. [000104] As shown in Figure 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. [000105] 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. [000106] Figures 5 to 11 present examples of embodiment of implant 20 according to the invention. [000107] With reference to Figure 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 across 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. [000108] With reference to figure 6, the implant 60 shown in side view is similar to the implant 50 of figure 4 with anterior edges 64 and posterior edges 66 as well as walls of the protrusions 68 beveled or rounded. [000109] With reference to Figure 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 outgrowth 78 is located near the anterior edge 74 and a second outgrowth 79 is located near the posterior edge 76. [000110] Figure 8 shows an implant 80 also comprising two protrusions 88. The body 82 has different widths, including a step at the posterior edge 86. [000111] Figure 9 shows an implant 90 comprising a plurality of outgrowths 98 extending perpendicularly to the anteroposterior axis. [000112] Figures 10 and 11 show implants 160 and 170 comprising a plurality of outgrowths 168 and 178. [000113] Figure 12 shows an ophthalmic implant 200 for permanent interposition between the sclera and the uveal tissue comprising an electronic module 220.

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 interposition ophthalmic implant according to claim 1, wherein the or each protrusion (36, 56, 68, 78, 79, 88, 98, 168, 178) defines an upper scleral contact surface, said upper contact surface of the or each protrusion occupying unitarily 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.

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 surface upper and passing through said outgrowth, said height of outgrowth 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. 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. 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. The ophthalmic interposition implant (50, 80, 170) of 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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