Intraocular implant, kit for implant placement, and method for implant placement

Abstract

An intraocular implant, a kit, and an installation method are disclosed. In one configuration, the intraocular implant has an elongated body configured to be installable at an installation position, and at the installation position, the body extends from the anterior chamber of the eye to the subconjunctival space of the eye. The body has a conduit structure that defines a conduit for facilitating the flow of aqueous humor through the conduit from the anterior chamber to the subconjunctival space. The body has an anchor fixing structure configured to expand from a radially contracted state to a radially expanded state.

Description

Technical Field

[0001] The present disclosure relates to an intraocular implant and associated implantation methods and kits.

Background Art

[0002] Glaucoma is a major cause of irreversible blindness and is a leading cause of blindness worldwide. Open-angle glaucoma (POAG) is a common type of ocular hypertension glaucoma, which is thought to be caused by the breakdown of the eye's drainage pathway. POAG can progress gradually over many years. Current treatment options for POAG are centered around intraocular pressure (IOP) reduction, which can be achieved by pharmacological topical drug therapy (e.g., drugs delivered as eye drops), laser treatment, or surgical intervention.

[0003] Minimally invasive glaucoma surgery (MIGS) is a new treatment option that has emerged in recent years. The reason for the popularity of MIGS lies in its improved safety profile compared to traditional glaucoma drainage surgeries. MIGS implants can be implanted using an ab-interno or ab-externo approach, with minimal or no scleral incision and minimal or no conjunctival manipulation.

[0004] MIGS implants have been demonstrated to effectively form an artificial drainage route for aqueous humor outflow and significantly reduce IOP. However, existing technologies have various drawbacks such as the device being prone to movement within the body and / or contributing to endothelial cell loss and / or hypotony.

[0005] An object of the present disclosure is to provide an improved implant and related devices and methods for treating glaucoma.

[0006] According to one aspect of the present invention, there is provided an intraocular implant, the intraocular implant being an elongated body configured to be installable at an installation position, having an elongated body extending from the anterior chamber of the eye to the subconjunctival space of the eye at the installation position, the body having a conduit structure defining a conduit for facilitating the flow of aqueous humor through the conduit from the anterior chamber to the subconjunctival space, and the body having an anchor fixation structure configured to expand from a radially contracted state to a radially expanded state.

[0007] Thus, the implant is provided with an anchor fixation structure that can take a radially contracted state to facilitate efficient insertion into the installation position extending from the anterior chamber to the subconjunctival space, and can expand to a radially expanded state when reaching the installation position. The conduit structure promotes the flow of aqueous humor that can lower the IOP, and the anchor fixation structure provides long-term positional stability and promotes bleb formation.

[0008] In one embodiment, the body can be manufactured by a manufacturing process including removing material from a hollow cylindrical tube in a region corresponding to the conduit structure and / or in a region corresponding to the anchor fixation structure. This approach enables the body to be manufactured efficiently, with high precision and productivity.

[0009] In one embodiment, the conduit structure is generally cylindrical in form in a relaxed state and defines one or more lateral openings configured to facilitate bending of the conduit structure about an axis perpendicular to the longitudinal axis of the conduit structure. This approach enables the flexibility of the conduit structure to be defined with high precision during the manufacturing process. It is desirable to control the flexibility of the conduit structure such that the conduit structure can be forced by tissue to curve into a shape that conforms to the tissue and has a bend stiffness equal to or less than the bend stiffness of the tissue along the installation route (e.g., through the scleral path) and / or in the region of the installation position. Thereby, the body can be reliably installed, minimizing the risk of discomfort, irritation / damage, and / or protrusion.

[0010] In one embodiment, the anchor fixation structure has a plurality of arms, at least a portion of which extends along a plurality of paths, each of which is located in a different plane that includes the longitudinal axis of the anchor fixation structure. By configuring the anchor fixation structure to have arms arranged in such a manner, it has been found that bleb formation is efficiently promoted. Aligning the arms within the plane that includes the longitudinal axis facilitates the manufacture of the implant and its insertion without causing damage.

[0011] In one embodiment, the arms are arranged in an asymmetric rotation manner to facilitate pushing the tissue asymmetrically in the region of the anchor fixation structure when the body is installed at the installation position. Configuring the anchor fixation structure to be rotationally asymmetric can facilitate arranging the anchor fixation structure in a rotational arrangement that increases bleb formation, for example, arranging the arms to extend radially in a larger range in a direction where the subconjunctival tissue is supported to promote bleb formation.

[0012] In one embodiment, at least two, and optionally all, of the arms converge and are tied near or at the distal tip of the anchor fixation structure. Arranging the arms to reconnect in this way provides structural strength to the anchor fixation structure and avoids the arm ends being exposed and puncturing, irritating, or exceeding the safe range of the firmness of the arms that can be provided to the tissue.

[0013] In one embodiment, at least two, and optionally all, of the arms are separated from each other at the distal ends of the arms. Arranging the arms to be free at their distal ends provides more freedom to shape the arms to promote bleb formation and / or reduces interference with the flow of aqueous humor after the conduits of the conduit structure are left.

[0014] In one embodiment, the body is configured such that when the body is in a loose state before installation, the longitudinal axis of the conduit structure is inclined obliquely with respect to the longitudinal axis of the anchor fixing structure and aligned. By arranging the conduit structure to be inclined obliquely in this way and aligned with the anchor fixing structure, the compatibility between the body and the surrounding tissue at the installation position can be facilitated.

[0015] In one embodiment, the implant has a bioabsorbable material on or in the body, and the bioabsorbable material gradually dissolves over time after installation, and thereby gradually changes the effect of the implant on the flow of aqueous humor through the conduit defined by the conduit structure from the anterior chamber to the subconjunctival space. This gradual change may include, for example, the flow gradually increasing (i.e., the outflow resistance gradually decreasing). By configuring the implant to gradually increase the outflow in this way (not suddenly), the risk of early hypotony can be reduced.

[0016] Hereinafter, embodiments of the present disclosure will be further described by way of example with reference to the drawings.

Brief Description of the Drawings

[0017]

Figure 1

Figure 2

Figure 3

Figure 4

Figure 5

Figure 6

Figure 7

Figure 8

Figure 9

Figure 10

Figure 11

Figure 12

Figure 13

Figure 14

Figure 15

Figure 16

Figure 17

Figure 18

Figure 19

Figure 20

Figure 21

Figure 22

Figure 23

Figure 24

Figure 25

Figure 26

Figure 27

Figure 28

Figure 29

Figure 30

Figure 31

DETAILED DESCRIPTION OF THE INVENTION

[0018] FIG. 1 is a cross-sectional perspective view showing a part of a human eye 2. The human eye is spherical with a diameter of approximately 2.5 cm. The cornea 4 forms one-sixth of the circumference of the sphere, and the sclera 6 forms the remaining five-sixths. The anterior chamber 8 is a space filled with aqueous humor between the iris 10 and the cornea 4. The posterior chamber 12 is a narrow space behind the iris 10 and in front of the lens 14. A human sees an object through the cornea 4, the aqueous humor, and the lens 14.

[0019] Aqueous humor is a clear liquid similar to plasma that maintains the eye pressure of the eye, provides nutrition for avascular eye tissues, and removes waste products from these tissues. Aqueous humor is secreted by the ciliary body 16 by the epithelium and fills both the anterior chamber and the posterior chamber. In a healthy eye, as the ciliary body 16 secretes new aqueous humor, a continuous flow of aqueous humor exits the eye. Most (70% - 90%) of the excess aqueous humor exits the anterior chamber through the trabecular meshwork and Schlemm's canal. This canal drains into 25 - 35 collector channels and 2 - 8 aqueous veins. A portion (10% - 30%) of the aqueous humor is drained via the suprachoroidal space. When these natural drainage channels become blocked, the eye pressure increases. Glaucoma is a condition in which the optic nerve connecting the eye to the brain is damaged under such high intraocular pressure (IOP).

[0020] Implants can be used to increase aqueous humor outflow and avoid dangerous IOP, but existing implants have been found to have various drawbacks as described in the introduction of this description. Embodiments of the present disclosure aim to at least partially address one or more of these drawbacks.

[0021] Referring to FIG. 2, an intraocular implant is disclosed as having an elongated body 22. The body 22 is configured to be installable at an installation position within the eye. The body 22 has a conduit structure 24 and an anchor fixation structure 26. An exemplary body 22 installed at the installation position is shown in FIG. 2. When at the installation position, the body 22 extends from the anterior chamber 8 to the subconjunctival space 18. The conduit structure 24 defines a conduit for facilitating the flow of aqueous humor through the conduit from the anterior chamber 8 to the subconjunctival space 18. The installation position may be such that when the body 22 is at the installation position, the conduit structure 24 extends a small amount (e.g., about 1 mm) into the anterior chamber 8. The body 22 may be coated with a biocompatible coating (e.g., silicon, parylene C, poly(styrene-block-isobutylene-block-styrene) (SIBS), etc.).

[0022] The anchor fixation structure 26 is configured to expand from a radially contracted state to a radially expanded state. The anchor fixation structure 26 may expand, for example, from a radially contracted state to a radially expanded state substantially without expansion of the conduit structure 24. Thus, the expansion of the anchor fixation structure 26 may occur independently of the conduit structure 24. The anchor fixation structure 26 may be configured to self-expand and / or may be configured to expand by applying a stimulus by balloon actuation, hydraulic actuation, thermal actuation, or magnetic actuation by choice.

[0023] The anchor fixation structure 26 may provide an anchor fixation force that generally resists longitudinal movement of the body 22 when in a radially expanded state. Thus, the anchor fixation structure 26 provides positional stability and causes the body 22 to reliably remain in the desired installation position after installation. In some embodiments, the anchor fixation structure 26 may be configured to promote bleb formation in the subconjunctival space 18 when the body 22 is installed in the installation position and the anchor fixation structure 26 is in a radially expanded state. This functionality persists, and the formed bleb may sometimes be referred to as a "long-term subconjunctival bleb". The anchor fixation structure 26 is configured, for example, to have sufficient stiffness and an appropriate outer shape that conforms to the tissue (e.g., pushes back) to promote bleb formation in the subconjunctival space. The anchor fixation structure 26 may push the tissue away from the axis of the anchor fixation structure 26, thereby supporting the tissue away from the installation area. The anchor fixation structure 26 may have a maximum radial diameter in the range of about 0.2 mm to about 3.5 mm, preferably about 0.75 mm to about 2.0 mm, when installed in a radially expanded state at the installation position. These size ranges have been found to be suitable for providing an appropriate balance between expanding the subconjunctival space to promote bleb formation and avoiding negative effects such as hypotony, retinal detachment, or excessive damage to the tissue.

[0024] In some embodiments, the body 22 is configured to be insertable into the installation position while radially contracting the anchor fixing structure 26 by applying a radially constraining force to the body 22 during insertion. This facilitates the insertion of the body 22 into the installation position and / or minimizes the degree of risk and / or discomfort and / or damage. For example, the anchor fixing structure 26 may be configured such that the body 22 fits snugly inside a 25-27G delivery needle when the anchor fixing structure 26 is in a radially contracted state. The body 22 may be installed at the installation position by releasing the radially constraining force applied to the body 22 that allows the anchor fixing structure 26 to self-expand. Thus, once the body 22 is positioned as desired, the anchor fixing structure 26 can be allowed to expand to effectively fix the body 22 in place, thereby resisting unwanted longitudinal movement away from the desired installation position.

[0025] In some embodiments, the conduit defined by the conduit structure 24 has a substantially constant cross-sectional area along the length of the conduit. The conduit may be, for example, substantially cylindrical. The cross-sectional area and the length of the conduit and / or the wall thickness of the conduit structure 24 may be selected to control the outflow resistance when installed such that it is low enough to treat high IOP but not so low as to cause hypotony. The conduit is typically configured to have an outflow resistance that can control (e.g., decrease) the IOP to be maintained in a range of, for example, about 4-20 mmHg, preferably about 6-12 mmHg. The conduit structure 24 may be designed to achieve an appropriate outflow resistance, for example, using Hagen-Poiseuille's law.

[0026] In some embodiments, the conduit structure 24 is generally cylindrical in shape in a relaxed state (e.g., before installation, when no external force is applied to the body 22 at all). The conduit structure 24 may define one or more lateral openings that facilitate bending of the conduit structure about an axis perpendicular to the longitudinal axis of the conduit structure 24. The lateral openings may be referred to as a plurality of cutouts, notch patterns, or radial openings. The lateral openings may be provided in various patterns (e.g., lattice, porous, etc.), but are preferably configured such that the resulting stiffness of the conduit structure 24 is equal to or less than that of the tissue at the intended installation location. In one exemplary arrangement, as shown in FIG. 7, the conduit structure 24 may be formed in a helix (i.e., having lateral openings that define the helix). Alternatively or additionally, the lateral openings may form a plurality of individual cells that define a lattice structure. The lateral openings may define a porous structure. Thus, the conduit structure 24 can be made relatively flexible. The conduit structure 24 may be bent at an angle that allows the conduit structure 24 to conform to the surrounding tissue and connect the anterior chamber to the subconjunctival space while maintaining a fluidly continuous conduit along the length of the conduit structure 24. For example, the conduit structure 24 may be configured to be bent at an angle of at least 20°, optionally at least 30°, optionally at least 45° while maintaining a fluidly continuous conduit along the length of the conduit structure 24. In some embodiments, the bend stiffness of the conduit structure 24 is selected to be equal to or less than the bend stiffness of the tissue along the installation route (e.g., through the scleral tunnel) and / or in the region of the installation location such that the conduit structure 24 can be forced by the tissue to bend into a shape that conforms to the tissue. Configuring the conduit structure 24 to be flexible in this way minimizes the risk of discomfort, irritation / damage, and / or protrusion and allows for secure installation of the body 22. The conduit structure 24 can, for example, bend to follow the curvature of the scleral tunnel during insertion.

[0027] The portion 42 of the conduit structure 24 adjacent to the anchor fixing structure 26 may be configured to have fewer lateral openings than the region of the conduit structure 24 disposed further away from the anchor fixing structure 26, or the portion 42 may be configured to have no lateral openings at all for a part of the length of the conduit structure 24 (as exemplified in the embodiments shown in FIGS. 3 to 27). This is because the bending moment may tend to be higher in this region, so reducing or avoiding the lateral openings in this portion 42 can reduce or avoid the risk of critical failure in this region. As will be described later, in some embodiments, intentional bending (angling at an oblique angle) may be provided between the conduit structure 24 and the anchor fixing structure 26, and the stronger strength provided to the portion 42 may be used to maintain or support the bending.

[0028] The body 22 may be manufacturable by a manufacturing process including removing material from a hollow cylindrical tube. The material may be removed, for example, by laser etching. The material may be removed in the region corresponding to the conduit structure 24 and / or in the region corresponding to the anchor fixing structure 26. Removal of the material from the region corresponding to the conduit structure 24 may increase the flexibility of the conduit structure 24 (for example, by providing one or more lateral openings facilitating bending about an axis perpendicular to the longitudinal axis of the conduit structure 24 as described above). The manufacturing process may include deforming the tube in the region after removal of the material in the region corresponding to the anchor fixing structure 26. This deformation may define the anchor fixing structure 26 and may be configured such that the anchor fixing structure 26 self-expands from a radially contracted state to a radially expanded state. Other manufacturing techniques such as additive manufacturing may also be used.

[0029] In some embodiments, as illustrated in FIGS. 3-7, FIGS. 8-11, FIGS. 12-15, FIGS. 16-19, FIGS. 20-23, and FIGS. 24-27, the anchor fixation structure 26 may have a plurality of arms 28. The arms 28 may extend generally in the longitudinal direction while diverging and / or converging radially. At least some of the plurality of arms may extend along respective paths located in different planes each including the longitudinal axis of the anchor fixation structure (thus providing arms that extend along paths having axially aligned components). Configuring the anchor fixation structure 26 with such arms 28 has been found to efficiently promote bleb formation while being readily manufacturable. The axial alignment of the arms minimizes the risk of irritation / damage and facilitates insertion of the implant. The arms 28 may be formed by laser etching an opening that extends longitudinally in a region of a cylindrical tube and compressing that region of the tube longitudinally. The arms 28 are configured to diverge radially as a function of position toward the distal tip 40 of the body 22 along at least a portion of the longitudinal axis of the anchor fixation structure 26 when the anchor fixation structure 26 is in a radially expanded state, as illustrated in the embodiments of FIGS. 3-27. As shown in FIG. 4, for example, the radial divergence of the arms may occur along a first portion 31 of the longitudinal axis of the anchor fixation structure 26. In some embodiments, the plurality of arms 28 may converge radially as a function of position toward the distal tip 40 of the body 22 along at least a portion of the longitudinal axis of the anchor fixation structure 26, for example, along a second portion 32 of the longitudinal axis of the anchor fixation structure 26 as shown in FIG. 4. The first portion 31 is between the conduit structure 24 (and, if present, portion 42) and the second portion 32.

[0030] In some embodiments, as illustrated in FIGS. 3-7, the maximum radial divergence of the arms 28 is the same. This can be most readily seen in the end view of FIG. 5. In this embodiment, the anchor fixation structure 26 has four arms 28, each of which extends radially outward by the same amount. In this example, all of the arms 28 have the same profile along the entire longitudinal length of the anchor fixation structure 26. The anchor fixation structure 26 is rotationally symmetric about the longitudinal axis four times. In other embodiments, the anchor fixation structure 26 may have higher or lower symmetry. For example, in some embodiments, the anchor fixation structure 26 may have two-fold or three-fold rotational symmetry, or rotational symmetry greater than four-fold.

[0031] In some embodiments, the anchor fixation structure 26 is configured to be rotationally asymmetric about the longitudinal axis (e.g., to have one-fold rotational symmetry). The rotational asymmetry may facilitate pushing the tissue rotationally asymmetrically away in the region of the anchor fixation structure when the body is placed in the placement position. Configuring the anchor fixation structure 26 to be rotationally asymmetric may facilitate placing the anchor fixation structure 26 in a rotational arrangement that increases bleb formation. For example, when viewed along the longitudinal direction, the anchor fixation structure may be configured to extend radially over a wider range on one side (e.g., the entire 180°) than on the opposite side (e.g., the other entire 180°), which may be referred to as the "relatively flat side". This configuration can be arranged in a desired orientation such that when the body 22 is in the placement position, this relatively flat side is adjacent to the sclera and the more radially extending side is disposed on the opposite side, acting to support the subconjunctival tissue and efficiently promote the formation of a long-term bleb.

[0032] In some embodiments, as illustrated in FIGS. 8-11, FIGS. 12-15, FIGS. 20-23, and FIGS. 24-27, at least two arms 28 have different maximum radial divergences. For example, two or more arms 28A may have the same maximum radial divergence, and one arm 28B may have a smaller maximum radial divergence. In the example above, the anchor fixation structure 26 has four arms including three arms 28A having the same maximum radial divergence and one arm 28B having a smaller maximum radial divergence. In this case, the arm 28B having the smaller maximum radial divergence can be positioned at a desired location adjacent to the sclera defining a relatively flat side of the anchor fixation structure 26 while the other three arms 28A support the subconjunctival tissue and efficiently promote the formation of a long-term bleb.

[0033] In some embodiments, as illustrated in FIGS. 3-27, the plurality of arms 28 may have a first pair of arms extending along a path located in the same first plane and a second pair of arms extending along a path located in the same second plane, and these first and second planes may be optionally orthogonal to each other. In some embodiments, one or more pairs of arms in the same plane are arranged mirror-symmetrically with respect to each other.

[0034] In some embodiments, as illustrated in FIGS. 3-7, FIGS. 8-11, and FIGS. 12-15, at least two, optionally all, of the arms converge and join (connect to each other) at or near the distal tip of the anchor fixation structure 26. In the illustrated embodiment, all four arms 28 join at the distal tip 40. By arranging the arms 28 to join again in this way, structural strength is provided to the anchor fixation structure 26 and the exposed arm ends, which could otherwise puncture or irritate tissue or limit the safe range of arm stiffness that can be provided, are avoided.

[0035] In contrast, in some embodiments, as illustrated in FIGS. 16-19, FIGS. 20-23, and FIGS. 24-27, at least two arms 28 are separated from each other (i.e., are free) at the distal ends of the arms (at or near the distal tip 40 of the anchor fixation structure 26). By arranging some of the arms 28 to be free at their distal ends, a greater degree of freedom is provided in forming the shape of the arms that promotes bleb formation and / or reduces interference with the flow of aqueous humor after the conduit of the conduit structure 24 is left. A higher anchor fixation force can be achieved with a given arm stiffness.

[0036] In some embodiments, as illustrated in FIGS. 3-7, FIGS. 8-11, FIGS. 16-19, and FIGS. 20-23, the body 22 may be configured such that the longitudinal axis 24 of the conduit structure is coaxial with the longitudinal axis of the anchor fixation structure 26 when the body 22 is in a loose state (i.e., no significant external force is applied to the body 22) before installation. By arranging the conduit structure 24 to be axially aligned with the anchor fixation structure 26 in such a way, the insertion of the body 22 into the installation position and / or the manufacture of the body 22 can be facilitated.

[0037] In contrast, in some embodiments, as illustrated in FIGS. 12-15 and FIGS. 24-27, the body 22 may be configured such that the longitudinal axis of the conduit structure is obliquely inclined and aligned with the longitudinal axis of the anchor fixation structure 26 (e.g., by bending in the portion 42 as described above) when the body 22 is in a loose state before installation. The portion 42 can be stronger than the peripheral portion of the body (even if different parts of the body are manufactured from tubes of the same starting material) due to having fewer lateral openings, which enables bending of the portion 42 and thereby maintains the obliquely inclined relative arrangement. By arranging the conduit structure 24 to be obliquely inclined and aligned with the anchor fixation structure 26 in such a way, the fit between the body 22 and the surrounding tissue at the installation position can be facilitated.

[0038] The body 22 can be made in dimensions selected to provide desired structural and mechanical attributes from a variety of biocompatible materials. Metallic or non-metallic materials can be used. Examples of materials include stainless steel, cobalt chrome, tantalum, titanium, nitinol and shape memory polymers, or bioresorbable materials. In some embodiments, the body 22 may be provided with a biocompatible coating that improves anchor fixation performance and / or anti-fibrotic properties. Alternatively or additionally, the body 22 may contain a therapeutic agent supported by the body 22. The therapeutic agent may be incorporated into a polymeric coating deposited on the outer and / or inner surfaces of the body 22. In some embodiments, the therapeutic agent includes an anti-glaucoma drug and / or a biodegradable drug matrix. Examples of anti-glaucoma drugs include prostaglandin analogs. In some embodiments, the implant has a biocompatible coating on or within the body that changes the flow of aqueous humor (e.g., by changing the outflow resistance) to improve IOP regulation and / or changes the stiffness of the body or a part of the body. The coating may form an inner and / or outer layer of the body. The coating may be configured to elute a drug.

[0039] In certain embodiments, a kit for implanting the implant into the eye is provided. The kit may have an implant according to any of the embodiments described herein. As illustrated in FIGS. 28 and 29, the kit may further have a delivery system 44 configured to deliver the implant to the implantation site. The implant may be provided pre-attached or encapsulated in the delivery system 44. The delivery system 44 may have a delivery sheath that includes the implant. The delivery sheath may be configured (e.g., shaped and / or dimensioned) to be inserted through the anterior chamber of the eye to the implantation site. The delivery system 44 may be configured such that the delivery sheath can be withdrawn from the eye while leaving the implant in the eye.

[0040] Delivery system 44 may have a handle 46 and a retrieval mechanism 48. The retrieval mechanism 48 has gears and racks configured to drive relative movement between the delivery sheath and the implant within the delivery sheath. A core member having a wire or tube may be provided within the delivery sheath so that the delivery sheath can be withdrawn without corresponding movement of the implant. In certain embodiments, the lumen of the delivery sheath is smaller than the radius of the implant when the anchor fixation structure 26 is in the radially expanded state such that the anchor fixation structure 26 is constrained in a radially contracted state when within the delivery sheath. The size of the core member is defined by the size of the delivery sheath. After insertion into the anterior chamber, the distal end of the delivery sheath advances to the installation position. Thereafter, the retrieval mechanism 48 is actuated to pull the delivery sheath rearward relative to the body 22 while the body 22 is maintained in the same position by the core member, thereby installing the body 22. After the implant is fully installed, the core member and sheath may be withdrawn from the suprachoroidal space.

[0041] In some embodiments, a bioresorbable material (e.g., suture) is provided on or within the body 22. The bioresorbable material may be provided as a coating and / or may elute a drug. The bioresorbable material may be provided on the inner and / or outer sides of any or all of the conduit structure 24, portion 42, and / or anchor fixation structure 26. The bioresorbable material may be configured to dissolve gradually over time after installation, thereby being configured to gradually change the effect of the implant on the flow of aqueous humor through the conduit from the anterior chamber to the subconjunctival space. This gradual change may include, for example, a gradual increase in the flow (i.e., a gradual decrease in the outflow resistance). By configuring the implant to gradually increase outflow in such a way (rather than suddenly), the risk of early hypotony can be reduced. This gradual change may occur over a period of at least 1 day, optionally at least 1 week, optionally at least 2 weeks, optionally at least 4 weeks, optionally at least 2 months, optionally at least 6 months.

[0042] In one embodiment, the bioresorbable material is provided inside a part of the body, such as inside the conduit defined by the conduit structure 24 (or the internal lumen), so that as the bioresorbable material gradually dissolves, it gradually removes the blockage of the conduit. Alternatively or additionally, the bioresorbable material may be configured to mechanically restrain the anchor fixation structure 26, so that as the bioresorbable material gradually dissolves (as the bioresorbable material becomes thinner and mechanically weaker, the restraining effect gradually becomes looser), the anchor fixation structure is gradually expanded. FIGS. 30 and 31 are schematic views showing the provision of a bioresorbable material as a coating 50 on an anchor fixation structure 26 of the type schematically illustrated in FIGS. 9 and 17, respectively. The coating 50 provides a web or membrane that extends (e.g., in an umbrella shape) between the individual arms 28 of the anchor fixation structure 26. The coating 50 in the form of a membrane is impermeable or porous. The membrane may be provided in the form of a mesh. As the coating dissolves, the arms 28 are gradually allowed to extend further radially outward. In other embodiments, the membrane may be configured to remain permanently in place (i.e., non-bioresorbable).

[0043] In some embodiments, the coating 50 is provided to increase the smoothness of the outer surface of the body 22. The coating 50 may cover the arms 28 of the anchor fixation structure 26 without necessarily being stretched between the arms 28. In this way, the coating 50 can be provided in a way that maintains the porosity of the anchor fixation structure 26. Also, the coating 50 may be applied to the conduit structure 24 in a way that maintains the porosity of the conduit structure 24. Alternatively, the coating 50 may be applied such that the conduit structure 24 and / or the anchor fixation structure 26 become impermeable due to the coating 50 (e.g., a coating stretched across the lateral opening of the body 22). Such an impermeable coating may be applied radially inside any part of the body 22 and / or radially outside any part of the body 22. When such a coating is applied inside or outside the body 22, this may enable particularly accurate control of the outflow resistance because the prediction of the flow characteristics of a solid impermeable tube is easier compared to the case of a tube having a lateral opening.

[0044] In some embodiments, the body 22 may have a biocompatible dissolvable suture that holds the anchor fixation structure 26 in a radially contracted state before and during delivery of the body 22 to the implantation site, which may facilitate implantation. As described above, the biocompatible dissolvable suture may be configured such that the size of the anchor fixation structure can gradually increase at a later time, and may be applied to controllably reduce the IOP and reduce the risk of early hypotony.

[0045] A method may be provided for implanting an implant according to any of the embodiments described herein. The method may include inserting the implant into the eye and positioning the implant at the implantation site. The method may optionally be augmented by intraoperative application or injection of a therapeutic composition such as mitomycin C (MMC).

Claims

1. The intraocular implant is an elongated body configured to be installable at an installation position, the body having at the installation position an extension from the anterior chamber of the eye to the subconjunctival space of the eye, the body having a conduit structure that defines the conduit for facilitating the flow of aqueous humor through the conduit from the anterior chamber to the subconjunctival space, and the body having an anchor fixation structure configured to expand from a radially contracted state to a radially expanded state. An intraocular implant.

2. The anchor fixation structure is configured to promote bleb formation in the subconjunctival space and / or to push tissue away from the axis of the anchor fixation structure when the body is installed at the installation position and the anchor fixation structure is in the radially expanded state. The implant according to claim 1.

3. The anchor fixation structure is configured to expand from a radially contracted state to a radially expanded state substantially without expansion of the conduit structure. The implant according to claim 1 or 2.

4. The anchor fixation structure is configured to self-expand and / or is configured to be expanded by applying a stimulus by balloon actuation, hydraulic actuation, thermal actuation or magnetic actuation by choice. The implant according to any one of the preceding claims.

5. The body is configured to be insertable into the installation position with the anchor fixation structure in the radially contracted state by applying a radially restraining force to the body during insertion, and to be installable at the installation position by releasing the radially restraining force applied to the body to enable the anchor fixation structure to self-expand. The implant according to any one of the preceding claims.

6. The conduit defined by the conduit structure has a substantially constant cross-sectional area along the length of the conduit. The implant according to any one of the preceding claims.

7. The conduit is configured to provide an outflow resistance that can control the intraocular pressure to be maintained in the range of about 4 to 20 mmHg, preferably in the range of about 6 to 12 mmHg, when installed. The implant according to any one of the preceding claims.

8. The implant according to any one of the preceding claims, wherein the anchor fixing structure is configured such that when installed in an expanded state in the radial direction at the installation position, the maximum radial diameter is in the range of about 0.2 mm to about 3.5 mm.

9. The implant according to any one of the preceding claims, wherein the body can be manufactured by a manufacturing process including removing material from a hollow cylindrical tube in a region corresponding to the conduit structure and / or in a region corresponding to the anchor fixing structure.

10. The implant according to claim 9, wherein removal of material from the region corresponding to the conduit structure increases the flexibility of the conduit structure and optionally forms a helix.

11. The implant according to claim 9 or 10, wherein the manufacturing process includes deforming the tube in the region corresponding to the anchor fixing structure after removing material in the region corresponding to the anchor fixing structure, in order to define the anchor fixing structure such that the anchor fixing structure self-expands from a radially contracted state to a radially expanded state.

12. The implant according to any one of the preceding claims, wherein the conduit structure is generally cylindrical in a relaxed state and defines one or more lateral openings configured to facilitate bending of the conduit structure about an axis perpendicular to the longitudinal axis of the conduit structure.

13. The implant according to any one of the preceding claims, wherein the anchor fixing structure has a plurality of arms, and at least some of the arms extend along respective paths located in different planes each including the longitudinal axis of the anchor fixing structure.

14. The implant according to claim 13, wherein the arms are arranged in an asymmetric rotation manner to promote asymmetric rotation of tissue away from the region related to the anchor fixing structure when the body is installed at the installation position.

15. The implant according to claim 13 or 14, wherein the arms are configured to diverge radially as a function of position towards the distal tip of the body along a first portion of the longitudinal axis of the anchor fixing structure when the anchor fixing structure is in a radially expanded state.

16. The implant according to claim 15, wherein at least two of said arms have different maximum radial divergences.

17. The implant according to claim 16, wherein two or more of said arms have the same maximum radial divergence and one of said arms has a lower maximum radial divergence.

18. The implant according to any one of claims 15 to 17, having a first pair of arms extending along a path located in the same first plane and a second pair of arms extending along a path located in the same second plane, wherein the first and second planes are selectively orthogonal to each other.

19. When the anchor fixing structure is in the radially expanded state, the plurality of arms converge radially as a function of the position towards the distal tip of the body along a second portion of the longitudinal axis of the anchor fixing structure, the first portion being between the conduit structure and the second portion. The implant according to any one of claims 15 to 18.

20. The implant according to any one of claims 13 to 19, wherein at least two of said arms converge and terminate near or at the distal tip of the anchor fixing structure.

21. The implant according to any one of claims 13 to 20, wherein at least two of said arms are separated from each other at the distal ends of the arms.

22. The implant according to any of the preceding claims, wherein the body is configured such that the longitudinal axis of the conduit structure is coaxial with the longitudinal axis of the anchor fixing structure when the body is in a loose state before installation.

23. The implant according to any one of claims 1 to 21, wherein the body is configured such that the longitudinal axis of the conduit structure is obliquely inclined and aligned with respect to the longitudinal axis of the anchor fixing structure when the body is in a loose state before installation.

24. Having a bioresorbable material on or in the body, the bioresorbable material being configured to gradually dissolve over time after installation, thereby gradually changing the effect of the implant on the flow of aqueous humor through the conduit defined by the conduit structure from the anterior chamber to the subconjunctival space. The implant according to any of the preceding claims.

25. The implant according to claim 24, wherein the bioresorbable material is provided inside a part of the body, and the gradually dissolving of the bioresorbable material gradually removes the blockage of the conduit. **Claim 26** The implant according to claim 24 or 25, wherein the bioresorbable material is configured to mechanically constrain the anchor fixation structure such that the gradually dissolving of the bioresorbable material gradually expands the anchor fixation structure. **Claim 27** A kit for implanting an implant into the eye, comprising: the implant according to any of the preceding claims; and a delivery system configured to deliver the implant to the installation position. **Claim 28** A method of implanting the implant according to any of claims 1 to 27, the method comprising inserting the implant into the eye and placing the implant at the installation position.

Images