Ophthalmic insert implant with one or more protrusions on upper surface

Abstract

The invention relates to an ophthalmic implant (20) for permanent insertion between sclera and uveal tissue, comprising a uveal compatible implant body (22) extending along a main axis (A) intended to be oriented in an anterior-posterior direction, the implant body comprises an upper surface (32) intended to face the sclera and a lower surface (34) intended to come into 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 the eye and a second edge (26), referred to as the posterior edge, opposite the anterior edge relative to the implant body. The lower surface is smooth, and the implant body includes one or more protrusions (36) extending from the upper surface toward the exterior of the body to allow the one or more protrusions to contact the sclera and to separate the sclera from the upper surface of the implant body.

Description

TECHNICAL FIELD

[0001] The present invention relates to an ophthalmic insertable implant for collecting aqueous humor from the anterior chamber to the suprachoroidal space and the suprachoroidal space for sustained reduction of intraocular pressure (IOP). BACKGROUND

[0002] Intraocular pressure is the result of aqueous humor secretion by the ciliary body and its balance between the efferent organ through the trabecular meshwork of the sclera, the Schlemm's canal and the general circulation via the aqueous veins. Depending on the age, 5% to 30% of this flow passes directly through the ciliary trabecula between the sclera and the ciliary body, this is the so-called uveoscleral flow. The longitudinal fibers of the ciliary muscle, especially during accommodation, act to tension the trabecular meshwork, promoting the uveoscleral flow of aqueous humor. The uveoscleral flow also occurs through these longitudinal fibers of the ciliary muscle.

[0003] For glaucoma, the aqueous humor flow through the corneoscleral trabecula is reduced, which in most cases leads to an increase in intraocular pressure (IOP). Reducing IOP is therefore a key factor in the medical and / or surgical treatment of glaucoma. Surgical treatment is based on two options: reducing the amount of aqueous humor produced by the ciliary body (ciliary body weakening) or increasing the outflow of aqueous humor by diverting it. This diversion can be achieved in various ways: - by establishing a direct connection between the anterior chamber and the suprachoroidal space with or without implant (ciliary body disconnection and its derivatives), but the effect obtained is often temporary and insufficient. This implant technique suppresses the physiological mechanism of uveoscleral flow in the surgical area by disconnecting the insertion of the ciliary muscle in the scleral spur. In addition, postoperative fibrosis extends beyond this area. It is also known that the part of the implant located in the anterior chamber can come into contact, even intermittently, with the corneal endothelium, leading to a significant risk of progressive corneal edema.

[0004] - by cutting the trabecula from the anterior chamber, all the way to the Schlemm's canal, to shorten the trabecular obstacle. This intervention can be supplemented by placing a stent open towards the anterior chamber in the canal to keep the aqueous humor permanently directly into the canal. Again, the results are often partial and temporary, without excluding the need for the patient to continue or resume medical treatment.

[0005] Filtration surgery remains the standard treatment and is used to divert aqueous humor under the conjunctiva to achieve the necessary decompression. It can create a permanent full-thickness opening within the trabecula under the scleral flap: this is called trabeculectomy. A variant of it is to leave an internal part of the trabecula in place, this is called non-penetrating trabecular surgery (deep sclerectomy, viscoanastomic canaloplasty).

[0006] However, filtering surgery presents complications related to insufficient filtration due to fibrosis of the filtering bleb (filtering bleb present between the sclera raised and the conjunctiva) or, conversely, complications related to excessive filtration due to the use of mitomycin C during surgery.

[0007] It is also known that there have been many attempts to use implants, in combination with the above surgical procedures or alone, to normalize IOP. However, these implants all more or less distort the anatomy of the eye and / or divert / alter the natural drainage path.

[0008] Most known cyclitic dissection implants serve to create a "forced conduit" for aqueous humor from the anterior chamber of the eye to the suprachoroidal space area, bypassing the iris root and the supraciliary space. It is evident from their design that: - when they are plate-like, they tend to force the circulation of aqueous humor through posteriorly oriented recesses, undulations or internal channels, - when they are "tubular", they are tubes that collect aqueous humor in the anterior chamber and drain it into the suprachoroidal space.

[0009] It is known in particular from document WO2016 / 156727 to avoid the creation of a filtering bleb by collecting aqueous humor on the posterior surface of the iris root without entering the anterior chamber and draining the sub-scleral aqueous humor towards the choroid, thus avoiding complications related to the invasion of the anterior chamber or the filtering bleb.

[0010] Whether or not the iris root is incised to access the anterior chamber, these implants consider the circulation of aqueous humor in the supraciliary space as a significant flow that can be collected and then directed into a tube. However, in normal anatomical structures, the sclera and the ciliary body are in direct contact and there are no blood vessels between them. Some preclinical and clinical studies show that the flow of water in this area is rather microscopic and diffuse. In addition, the purpose of all these implants is to transport aqueous humor from the ciliary body to the suprachoroidal space and bypass the absorption capacity of the sclera. Plate-like implants are usually solid in form and present a continuous or slightly serrated surface when in contact with the sclera.

[0011] These implants do not meet the need for free circulation of aqueous humor in the supraciliary space and improved absorption by the sclera.

[0012] A clinical trial with a device for creating a gap and a cavity between the sclera and the ciliary body (without filling the cavity with implant material) and without a geometry designed to direct aqueous humor in the anterior-posterior direction surprisingly showed better results in reducing IOP, in turn improving aqueous humor circulation and drainage. This trial clearly shows that the main difference in IOP reduction comes from the surface area of the scleral tissue available for aqueous humor absorption and the volume created by the "implant material-free" implant available for aqueous humor circulation.

[0013] Therefore, there is a need for an ophthalmic implant that does not have the above-mentioned drawbacks. In particular, there is a need for an ophthalmic implant that further promotes the absorption of aqueous humor by the sclera. SUMMARY

[0014] To this end, the present invention proposes an ophthalmic implant for permanent insertion between the scleral and uveal tissue, the implant comprising a uveally compatible implant body extending along a main axis for orientation along an anterior-posterior direction, the implant body comprising an upper surface for facing the sclera and a lower surface for contacting the uveal tissue, the implant body further comprising a first edge, referred to as an anterior edge, for orientation towards the anterior chamber of the eye and a second edge, referred to as a posterior edge, opposite the anterior edge with respect to the implant body, characterized in that the lower surface is smooth and in that the implant body comprises one or more protrusions extending from the upper surface towards the outside of the body to allow the one or more protrusions to come into contact with the sclera and to separate the sclera from the upper surface of the implant body.

[0015] The addition of protrusions on the upper surface separates the sclera from the ciliary body and also separates the sclera from the implant body, in particular from the upper surface of the implant body. Thus, a substantial part of the sclera is separated from the ciliary body while not being in contact with the implant. The protrusions create a tenting effect such that the sclera better absorbs aqueous humor, thereby reducing the intraocular pressure (IOP). The tenting effect refers to the lifting of the scleral tissue by local contact.

[0016] A clinical trial with the following device, which creates a gap and a cavity between the sclera and the ciliary body without filling the cavity with implant material and without a geometry designed to direct aqueous humor along the anterior-posterior direction, surprisingly showed a better effect of reducing the IOP, in turn improving the circulation and drainage of aqueous humor. The trial clearly shows that the main difference in IOP reduction comes from the surface area of the scleral tissue available for aqueous humor absorption and the volume created by the "implant material-free" implant available for aqueous humor circulation.

[0017] Therefore, the increase in the "empty" volume between the sclera and the ciliary body or the volume without the implant body greatly promotes the flow and circulation of aqueous humor.

[0018] In addition, having a smooth lower surface reduces the risk of irritation and damage to the ciliary body, in particular during the implant placement. Thus, the lower surface is not rough and does not have any protrusions.

[0019] The lower surface can have recesses or holes that pass through the body of the implant Figure 11without impairing the smoothness of the lower surface. In the case of one or more recesses or through-holes, the lower surface must be smooth around the recesses or through-holes. By "smooth" is meant that the lower surface is free of any protrusions around the recesses or holes. The dimension of the protrusions along a perpendicular to the main axis corresponding to the thickness of the implant is greater than or equal to 10 pm, preferably greater than or equal to 50 pm, and more preferably greater than or equal to 100 pm.

[0020] According to one embodiment of the ophthalmic insertable implant, the protrusion or each protrusion defines an upper surface in contact with the sclera, said upper contact surface of the protrusion or each protrusion collectively occupying at most 50% of the upper surface when the upper surface is projected onto an upper plane perpendicular to the normal to the upper surface.

[0021] According to one embodiment of the ophthalmic insertable implant, the protrusion or each protrusion defines a protrusion height measured 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, and more preferably greater than or equal to 100 pm.

[0022] According to one embodiment of the ophthalmic insertable implant, the protrusion or each protrusion defines a protrusion height measured 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, and even more preferably less than or equal to 800 pm.

[0023] According to one embodiment of the ophthalmic insertable implant, the protrusion or one of the protrusions extends mainly along an anteroposterior direction extending between a first edge and a second edge.

[0024] According to one embodiment of the ophthalmic insertable implant, the protrusion or one of the protrusions extends mainly along a direction perpendicular to the anteroposterior direction extending between a first edge and a second edge.

[0025] According to one embodiment of the ophthalmic insertable implant, the upper surface comprises an anterior portion disposed proximate to the first edge and a posterior portion disposed proximate to the second edge, and the protrusion or one of the protrusions is disposed in said posterior portion.

[0026] According to one embodiment of the ophthalmic insertable implant, the implant body comprises a plurality of protrusions extending from the upper surface towards the exterior of the body.

[0027] According to one embodiment of the ophthalmic insertable implant, the upper contact surfaces of the plurality of protrusions collectively occupy at most 50% of the upper surface when the upper surface is projected onto an upper plane perpendicular to the normal to the upper surface.

[0028] According to one embodiment of the ophthalmic insertable implant, the plurality of protrusions includes at least two protrusions disposed between the first edge and the second edge.

[0029] According to one embodiment of the ophthalmic insertable implant, the lower surface includes at least one recess in communication with the upper surface to allow fluid to flow from the lower surface to the upper surface.

[0030] According to one embodiment of the ophthalmic insertable implant, the at least one recess occupies at least 5% of the lower surface when the lower surface is projected onto a lower plane normal to a normal to the lower surface.

[0031] According to one embodiment of the ophthalmic insertable implant, the implant body defines a maximum length measured along an anterior-posterior axis extending between the first edge and the second edge and a maximum width measured along an axis perpendicular to the anterior-posterior axis, the maximum width of the implant body being equal to or greater than the maximum length of the implant body.

[0032] According to another aspect, in combination or independently of the above features, the application proposes an ophthalmic insertable implant of permanent nature between the scleral and uveal tissues, comprising a uveal compatible implant body extending along a main axis for orientation along an anterior-posterior direction, said implant body comprising an upper surface for facing the sclera and a lower surface for contact with the uveal tissues, said implant body further comprising a first edge, called anterior edge, for orientation towards the anterior chamber of the eye and a second edge, called posterior edge, opposite the anterior edge with respect to the implant body, characterized in that it further comprises an electronic module configured to determine at least one information about the user, the state of the ophthalmic implant or information external to the implant, and a battery for powering the electronic module.

[0033] The electronic module enables the implant to communicate, as it is able to acquire and send characteristics or information related to its environment. Thus, in addition to facilitating the flow and diffusion of aqueous humor to reduce intraocular pressure, the implant is also able to perform intelligent functions (information acquisition).

[0034] Thus, the electronic module enables the implant to communicate while performing its main function of reducing intraocular pressure and exerting a depressor effect.

[0035] The electronic module can comprise one or more of the following: a sensor, a 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 send information.

[0036] The user information can be one or more of the following: temperature, humidity level and intraocular pressure value.

[0037] The determination of the user information can be performed, for example, by means of a sensor arranged within the ophthalmic implant. The measurements from the implant are preferably stored in a memory inside the implant or transmitted to an external device.

[0038] The information on the implant status can comprise one or more of the following: the battery charge level and the position of the implant between the sclera and the ciliary body.

[0039] The information on the implant status can be determined by communication between the electronic components of the electronic module.

[0040] The external information can be one or more of the following: an instruction to activate or deactivate the electronic module, an instruction to collect information or make measurements by means of the sensors, and an instruction to transmit information from the implant to an external device.

[0041] According to one embodiment, whether or not combined with the features described above, the implant is configured to modify at least one of its properties: at least one of its longitudinal, transverse and thickness dimensions, its anterior-posterior position between the sclera and the ciliary body.

[0042] The modification of one of its properties is preferably activated by the electronic module inside the implant. This activation can be automatic, i.e. pre-programmed in the internal memory of its controller, or also manual, i.e. by sending a command from the external device to the communication means of the electronic module. This command may, for example, be a command to change the thickness of the implant sent by the surgeon after the implant has been implanted in the patient's body.

[0043] According to another aspect of the application, whether or not combined with the features described above, the implant is configured to deliver an active ingredient to the user when it is placed between the sclera and the ciliary body. This delivery or transfer of the active ingredient can be "passive", i.e. achieved only by the contact between the user's tissues and the implant, or "active", i.e. the electronic module is configured to be activated to deliver the active ingredient. BRIEF DESCRIPTION OF DRAWINGS

[0044] The following description of the drawings, provided as a non-limiting example, will clarify the application and how it can be implemented. In the drawings: [ Figure 1 ] Figure 1 A schematic perspective view of an implant is shown, the implant comprising a protrusion protruding from the upper surface of the implant body.

[0045] [ Figure 2 ] Figure 2 A schematic view of one possible general shape of an implant according to the application is shown, the implant being inserted between the sclera and the ciliary body in a human eye.

[0046] [ Figure 3 ] Figure 3 A more detailed enlarged view of the iridocorneal angle structure without Figure 2 is shown.

[0047] [ Figure 4 ] Figure 4 A schematic perspective view of an implant in Figure 1 is shown, wherein the implant body is provided with grooves.

[0048] [ Figure 5 ] Figure 5 A schematic perspective view of an example of an implant is shown, which implant comprises protrusions extending transversely to the front-to-back direction of the implant.

[0049] [ Figure 6 ] Figure 6 A schematic side view of another example of an implant is shown, which implant has bevelled and / or rounded front and back edges and a protruding wall.

[0050] [ Figure 7 ] Figure 7 A schematic perspective view of another example of an implant is shown, which implant comprises a plurality of protrusions and a body curved around an axis transversely to the front-to-back direction of the implant.

[0051] [ Figure 8 ] Figure 8 A schematic perspective view of another example of an implant design is shown, which implant design comprises a front edge and a back edge offset in the front-to-back direction of the implant.

[0052] [ Figure 9 ] Figure 9 A schematic perspective view of another example of an implant is shown, which implant comprises a plurality of protrusions with convex or rounded walls.

[0053] [ Figure 10 ] Figure 10 A schematic perspective view of another example of an implant is shown, which implant comprises a plurality of protrusions having different geometrical shapes from one another.

[0054] [ Figure 11 ] Figure 11 A schematic perspective view of another example of an implant is shown, which implant comprises a plurality of through-going recesses extending between a lower surface and an upper surface of the implant body, a plurality of substantially rectangular protrusions distributed on the upper surface of the body, a plurality of protrusions extending from the front edge to the back edge.

[0055] [ Figure 12 ] Figure 12An ophthalmic implant for permanent insertion between the scleral and uveal tissue is shown, which includes an electronic module capable of communicating between the implant and a third party device. DETAILED DESCRIPTION

[0056] The concepts of the present application are described more fully hereinafter with reference to the accompanying drawings. These drawings show specific embodiments of the concepts of the present application. In the drawings, the size and relative sizes of elements can be exaggerated for clarity. Like elements in the drawings are denoted by like reference numerals for consistency. This concept of the present application may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the concepts of the present application to those skilled in the art.

[0057] Reference throughout this specification to "an embodiment" means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment of the present application. Thus, the appearances of the phrase "in one embodiment" in various places throughout this specification are not necessarily referring to the same embodiment. Furthermore, the particular

[0058] The present application is illustrated with reference to the accompanying drawings, which show an ophthalmic insertable implant for collecting aqueous humor from the anterior chamber into the suprachoroidal space and facilitating the transfer of this aqueous humor between the sclera and the ciliary body for sustained reduction of intraocular pressure (IOP).

[0059] In the present specification, for the sake of clarity, hereinafter the ophthalmic insertable implant can be referred to as "implant".

[0060] Figure 1 An intentionally simplified implant 20 is shown, which is in accordance with the presented present application.

[0061] The implant 20 includes a uveally compatible body 22, i.e. the body is made of at least one material known to have uveally compatible properties. In other words, the at least one material does not change the overlying and underlying structures when the body 22 is in contact with these structures and repeatedly moved over time.

[0062] The body 22 extends along a main axis A for orientation in the anterior-posterior direction.

[0063] The body 22 of the implant 20 has three dimensions in space: a thickness e, a length L and a width I perpendicular to the thickness e. The ratio between the length L and the 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 the length vary, the body 22 defines a maximum length measured between the front edge 24 and the rear edge 26 along a main front-rear axis A, and a maximum width measured along an axis perpendicular to this main axis A. The maximum width is therefore preferably equal to or greater than the maximum length.

[0064] For example, the dimensions of the implant (width, length, thickness) can be 4 x 5 x 0.1 mm, or 3 x 6 x 0.8 mm, or 6 x 3 x 0.6 mm.

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

[0066] The length L of the body is preferably less than or equal to 6 mm, in order to fit the anatomy of the eye and without risk of injury.

[0067] The body 22 of the implant 20 comprises two opposite edges, a front edge 24 and a rear edge 26, which are spaced apart along the length L of the body 22.

[0068] The front edge 24 is intended to face or be close to the anterior chamber of the eye. The rear edge 26 is arranged opposite the front edge 24 with respect to the body 22 along the front-rear direction.

[0069] The body 22 also comprises side edges 28 and 30 extending between the front edge 24 and the rear edge 26 on either side of the body 22. The side edges 28 and 30 extend mainly along the length L of the body 22, and the front edge 24 and the rear edge 26 extend along the width I of the body 22.

[0070] The body 22 comprises an upper surface 32 intended to face the sclera and a lower surface 34 intended to come into contact with the uveal tissue, in particular the ciliary body.

[0071] The lower surface 34 is smooth so as to have very low resistance to the movement of the body 22 with respect to the ocular tissue. The lower surface 34 is intended to come into contact with the ciliary body, which is very fragile, especially with respect to the sclera. A smooth surface in contact with such tissue therefore reduces the risk of irritation and injury to the ciliary body, in particular during the implant placement. The lower surface is therefore not rough and does not have any protrusions.

[0072] The body 22 also comprises one or more protrusions 36 extending from the upper surface 32 towards the outside of the body 22 to allow contact between the one or more protrusions 36 and the sclera. The term "extending towards the outside" of the protrusions 36 means that the protrusions 36 protrude from the upper surface 32. The protrusions 36 thus have a protrusion thickness H measured along an axis perpendicular to the upper surface 32.

[0073] The protrusions 36 can have any shape or any cross-section.

[0074] The sclera and ciliary muscle are deformable tissues. The thickness of the protrusions 36 is chosen to take into account possible tissue deformations while ensuring that the deformed tissues do not obstruct the empty volume. This is particularly true for the ciliary muscle, which can deform significantly and can form hernias in any available volume.

[0075] The addition of one or more protrusions 36 on the upper surface 32 can separate the sclera from the ciliary body and also from the body 22 of the implant 20, in particular the upper surface 32 of the implant 20. Thus, a significant portion of the sclera is separated from the ciliary body while not being in contact with the implant. The protrusions 36 create a tent effect that allows the sclera to better absorb aqueous humor, which in turn reduces the intraocular pressure (IOP). The tent effect refers to the lifting of the scleral tissue by local contact.

[0076] The protrusions 36 serve to separate the tissues while creating an implant-free volume, i.e. an empty volume 121 (see Fig. 1) between these tissues. Figure 2 As mentioned above, a clinical trial with a device for creating a gap and a cavity between the sclera and the ciliary body without a geometry designed to direct the aqueous humor in the anterior-posterior direction, and without filling the cavity with implant material, surprisingly showed a better effect on reducing the IOP, and thus improving the circulation and drainage of the aqueous humor. This trial clearly shows that the main difference in IOP reduction comes from the surface area of the scleral tissue available for aqueous humor absorption and the volume created by the "implant-free material" implant available for aqueous humor circulation.

[0077] The sclera and ciliary muscle are deformable tissues. The design of the implant must take into account possible deformations and ensure that the empty volume it is supposed to create is not filled by the deformed tissues. This is particularly true for the ciliary muscle, which can deform significantly and is prone to form hernias in any available volume. However, for simplicity, it is considered that these hernias cannot be larger than half the width of their base, which is a design rule to be considered below.

[0078] Although the sclera deforms less, the same attention must be paid to the design of the face of the implant that comes into contact with it.

[0079] The implant is preferably formed from a single component, in the sense that it is formed in a single integral piece. Thus, the implant is not an assembly of several components fixed together to form the body.

[0080] Figure 2 A section showing the implant 20 in its functional position within the eye 110 of a patient is shown.

[0081] The section of this part of the eye 110 shows the anterior chamber 112, which is located between the cornea 114 and the lens 116, and the outer part of which is delimited by the iris 119. Behind the iris 119 is 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 between the sclera and the cornea changes. The sclera 122 covers the ciliary body 128, which is connected to the iris 119 and comprises the ciliary muscles 130 on which the sclera 122 is borne.

[0083] The trabeculae 134, located between the cornea and the iris, act as filtering structures, and the aqueous humour circulating in the anterior chamber 112 passes through the trabeculae 134.

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

[0085] The various arrows F1, F2, F3 and F4 show the paths or routes followed by the aqueous humour: - F1 denotes the usual path or flow followed by the aqueous humour entering the anterior chamber 112; - F3 denotes the usual path or flow followed by the aqueous humour leaving the anterior chamber 112 through the trabeculae 134 and towards the Schlemm's canal 136; - F4 denotes the usual uveoscleral physiological flow of the aqueous humour leaving the anterior chamber 112.

[0086] As mentioned above, the implant 20 is inserted between the sclera 122 and the ciliary muscle 130. This implant 20 is placed close to the root of the ciliary muscle 118, so as to exert its permanent spacing effect in the most appropriate location, while not affecting the insertion of the ciliary muscle 130 at the pars plana. The anterior edge 24 of the implant 20 can be placed at a distance from the root of the ciliary muscle 118 or in contact with it.

[0087] Figure 3 is a more detailed view in enlargement of the iridocorneal angle structure without implant. As shown in this figure, the scleral spur 132, into which the ciliary muscle 130 is inserted, is located above the uveal part 134a of the trabeculae 134.

[0088] Whether or not the leading edge 24 of the implant 20 contacts the root of the iris 119, the spacing created at this location between the sclera and the ciliary body allows the aqueous humor to collect permanently as close as possible to the physiological

[0089] As Figure 2 As illustrated by the arrows F4' located above and below the implant, the physiological

[0090] Each protrusion 36 defines an upper contact surface 38 with the sclera. This upper contact surface 38 is formed by the distal portion of said protrusion 36 and is intended to come into contact with the sclera when the implant 20 is placed between the sclera and the ciliary body.

[0091] As mentioned above, the purpose of the protrusions is to separate the sclera from the upper surface 32 of the implant 20. Several parameters can be used, alone or in combination, to improve the separation of the sclera from the implant. These parameters include the position, the shape, the distribution and the number of protrusions 36, more particularly of the upper contact surfaces 38.

[0092] When the upper surface 32 is projected onto an upper plane perpendicular to the normal to the upper surface 32, the upper contact surface 38 of the protrusion or of each protrusion can represent at most 50% of the upper surface 32. In other words, when the upper surface 32 is viewed from above, each upper contact surface 38 represents at most 50% of the upper surface 32. This upper contact surface 38 can have any shape allowing the separation of the sclera from the upper surface 32. As an example, the upper contact surface 38 viewed from above can be one or more straight or curved segments extending along a trajectory. The upper contact surface 38 can be continuous or discontinuous.

[0093] More preferably, when the upper surface 32 is projected onto an upper plane perpendicular to the normal to the upper surface 32, said upper contact surface 38 of the protrusion or of each protrusion represents at most 50% of the upper surface 32 as a whole.

[0094] Each protrusion 36 defines a protrusion height H (see Fig. 2) measured along an axis perpendicular to the upper surface 32 and passing through said protrusion 36. Figure 1 The protrusion height can be greater than or equal to 10 μιη, preferably greater than or equal to 50 μιη, and more preferably greater than or equal to 100 μιη. The term "protrusion height H" refers to the maximum protrusion height H.

[0095] Moreover, the height of the protrusions can 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 pm. The height of the protrusions can advantageously be between 100 pm and 500 pm.

[0096] The protrusions 36 can extend mainly along the front-rear direction, i.e. along the main axis A, and / or along a direction perpendicular to this front-rear direction.

[0097] The upper surface 32 comprises a front portion disposed near the front edge 24 and a rear portion disposed near the rear edge 26. A middle portion can also be defined between the front portion and the rear portion. The protrusions can be disposed only in the middle portion and / or in the rear portion of the upper surface 32, so as to separate the sclera from the upper surface 32 without damaging the tissues that connect to each other at the root of the iris. The protrusions can be disposed only in the rear portion so as to obtain a good balance between reducing the contact surface of the protrusions with the sclera and separating the sclera from the upper surface 32.

[0098] When the upper surface 32 is projected onto an upper plane perpendicular to the normal to the upper surface 32, the protrusions 36 can extend along an extended trajectory or main axis. Each protrusion 36 has a longitudinal dimension along this extended trajectory or main axis and a transverse dimension along an axis perpendicular to this extended trajectory or main axis. The longitudinal dimension and the transverse dimension are defined such that the transverse dimension is equal to or less than the longitudinal dimension. The transverse dimension can also be defined such that it is less than or equal to three times the height H of the protrusion. The transverse dimension can further be defined such that it is 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, when the upper surface 32 is projected onto an upper plane perpendicular to the normal to the upper surface 32, collectively occupy at most 50% of 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.

[0100] The lower surface 34 comprises at least one recess in communication with the upper surface 32, so as to allow the flow of fluid from the lower surface 34 to the upper surface 32. This recess can be a through hole extending between the upper surface 32 and the lower surface 34. Alternatively, this recess can be a plurality of holes or voids in communication with each other from the lower surface 34 to the upper surface 32. This recess can in particular be obtained by using a porous material.

[0101] When the lower surface 34 is projected onto a lower plane perpendicular to the normal to the lower surface 34, the at least one recess occupies at least 5% of the lower surface 34. These recesses allow the flow of aqueous humor from the ciliary body to the sclera.

[0102] The dimensions of these recesses are chosen so as to limit the development of a ciliary hernia, which would otherwise impede the flow of aqueous humor by clogging the recesses.

[0103] To further limit the development of a herniation, each recess can comprise a stopper able to block the penetration of tissue into the recess. Each recess defines a recess extension axis between the lower surface 34 and the upper surface 32. The stopper extends, for example, at least partially perpendicular to the recess extension axis. When the lower surface 34 is projected onto a lower plane perpendicular to the normal of the lower surface 34, the stopper preferably occupies at least 30% of the section of said recess.

[0104] As Figure 4 illustrated, the upper surface 32 can also comprise at least one recess. The recess can be in the form of a groove 31 or a hollow relief extending over all or part of the upper surface 32. The at least one recess can extend along the anteroposterior axis and / or along an axis transverse to the anteroposterior axis. The recess in the upper surface 32 is generally used to facilitate the flow of aqueous humor along the width and / or the length of the body 22 of the implant 20.

[0105] When the upper surface 32 comprises at least one recess, a recess bottom surface 33 is defined within said at least one recess. Within the meaning of the invention, the relief 36 extends from the upper surface 32 and not from the recess bottom surface 33.

[0106] Figures 5 to 11 An exemplary embodiment of an implant 20 according to the invention is illustrated.

[0107] With reference to Figure 5 , the implant 50 has a concave anterior edge 54 and a relief 56 extending perpendicular to the main anteroposterior axis A. The relief 56 extends across the entire width of the body 52 of the implant 50. The width of the body 52 is greater than its length. The cross-section of the relief is square or rectangular.

[0108] With reference to Figure 6 , the implant 60 illustrated in side view is similar to the implant 50 of Figure 4 , with an anterior edge 64 and a posterior edge 66 and a beveled or rounded relief wall 68.

[0109] With reference to Figure 7 , the implant 70 has a concave body 72 to fit the anatomy of the eye. The width of the body 72 varies continuously between an anterior edge 74 and a posterior edge 76. A first relief 78 is located near the anterior edge 74, while a second relief 79 is located near the posterior edge 76.

[0110] Figure 8 An implant 80 is illustrated which also comprises two reliefs 88. The body 82 has different widths, including a step at the posterior edge 86.

[0111] Figure 9 An implant 90 is illustrated which comprises a plurality of reliefs 98 extending perpendicular to the anteroposterior axis.

[0112] Figure 10 and Figure 11 Implants 160 and 170 are shown that include a plurality of protrusions 168 and 178.

[0113] Figure 12 An ophthalmic implant 200 for permanent insertion between scleral and uveal tissue is shown that includes an electronics module 220.

Claims

1. An ophthalmic insertable implant (20, 50, 60, 70, 80, 90, 160, 170) for permanent insertion between scleral and uveal tissue, comprising a uveally compatible implant body (22, 52, 72, 82) extending along a main axis (A) for orientation along an anterior-posterior direction, the implant body comprising an upper surface (32) for facing the sclera and a lower surface (34) for contacting the uveal tissue, the implant body further comprising a first edge (24, 54, 64, 74) for orientation towards the anterior chamber of the eye and a second edge (26, 66, 76, 86) for orientation towards the posterior chamber of the eye, 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 towards the outside of the body to allow the one or more protrusions to contact the sclera and to separate the sclera from the upper surface of the implant body.

2. The ophthalmic insertable implant according to claim 1, wherein the or each protrusion (36, 56, 68, 78, 79, 88, 98, 168, 178) defines an upper surface for contact with the sclera, the upper contact surface of the or each protrusion as a whole occupying at most 50% of the upper surface when the upper surface is projected onto an upper plane normal to a normal to the upper surface.

3. The ophthalmic insertable 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 measured along an axis normal to the upper surface and passing through the protrusion, the protrusion height being greater than or equal to 10 pm, preferably greater than or equal to 50 pm, and more preferably greater than or equal to 100 pm.

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

5. The ophthalmic insertable implant according to one of the preceding claims, wherein the or one of the protrusions extends mainly along an anterior-posterior direction extending between the first and second edges.

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

7. The ophthalmic insertable implant (70, 80, 90, 160, 170) according to one of the preceding claims, wherein the upper surface comprises an anterior portion disposed proximate the first edge and a posterior portion disposed proximate the second edge, and the or one of the protrusions is disposed in the posterior portion.

8. The ophthalmic insertable implant (70, 80, 90, 160, 170) according to one of the preceding claims 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 collectively occupy at most 50% of the upper surface when the upper surface is projected onto an upper plane perpendicular to a normal of the upper surface.

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

10. The ophthalmic insertable implant (170) according to one of the preceding claims, wherein the lower surface comprises at least one recess in communication with the upper surface to allow fluid to flow from the lower surface to the upper surface.

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

12. The ophthalmic insertable implant (50, 80, 170) according to one of the preceding claims, wherein the implant body defines a maximum length measured along an anterior-posterior axis extending between the first edge and the second edge and a maximum width measured along an axis perpendicular to the anterior-posterior 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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