Corneal implant with rigid ring

Abstract

In certain embodiments, the corneal implant includes a transparent dome and a ring. The transparent dome has a circular base with a periphery having a diameter of less than 2 centimeters. The transparent dome includes a transparent biocompatible material. The ring has an annular shape and is disposed around the periphery of the circular base of the transparent dome. The ring includes a biocompatible material having a surface. A peripheral portion of the surface forms openings that promote attachment of ocular tissue to the ring. Each opening has a diameter of less than 2 millimeters.

Description

[Technical Field]

[0001] The present disclosure relates generally to ocular implants, and more particularly to corneal implants with rigid rings. [Background technology]

[0002] Corneal diseases such as keratoconus, endothelial dystrophy, and bullous keratopathy can cause clouding and distortion of vision, ultimately leading to blindness. Surgical treatment for such diseases involves corneal transplantation. In this procedure, diseased corneal tissue is removed from the patient's eye and replaced with donor corneal tissue. However, in some cases, the patient's immune system rejects the donor corneal tissue. Summary of the Invention [Means for solving the problem]

[0003] In certain embodiments, the corneal implant includes a transparent dome and a ring. The transparent dome has a circular base with a periphery having a diameter of less than 2 centimeters. The transparent dome includes a transparent biocompatible material. The ring has an annular shape and is disposed around the periphery of the circular base of the transparent dome. The ring includes a biocompatible material having a surface. A peripheral portion of the surface forms openings that promote attachment of ocular tissue to the ring. Each opening has a diameter of less than 2 millimeters.

[0004] Embodiments may include none, one, some, or all of the following features. *Biocompatible materials include biocompatible metals or biocompatible plastics. * The openings have a density of at least 20 per square centimeter. * Each opening has a diameter of less than 1 millimeter. * The openings are arranged in a circle-packing pattern. * The openings form an artificial trabecular meshwork. The corneal implant includes a lens positioned outwardly from the circular base of the transparent dome and substantially centered within the periphery of the circular base of the transparent dome. An iris design may be printed on the lens. The corneal implant includes an iris component disposed outwardly from the circular base of the transparent dome and substantially centered within the periphery of the circular base of the transparent dome. A lens may be disposed outwardly from the iris component and substantially centered therewith. The corneal implant includes one or more flaps. Each flap has an attachment end that connects to a portion of the corneal implant and a suture end that can be sutured to ocular tissue. The attachment end can be connected to the periphery of the circular base or the peripheral portion of the ring. The flap can have one or more drainage channels, each channel allowing fluid to move between the attachment end and the suture end.

[0005] In certain embodiments, the corneal implant includes a transparent dome, a ring, a lens, and one or more flaps. The transparent dome has a circular base with a periphery having a diameter of less than 2 centimeters. The transparent dome includes a transparent biocompatible material. The ring has an annular shape and is disposed around the periphery of the circular base of the transparent dome. The ring includes a biocompatible material having a surface. A peripheral portion of the surface forms openings that promote attachment of ocular tissue to the ring. Each opening has a diameter of less than 2 millimeters. The lens is disposed outward from the circular base of the transparent dome and substantially centered within the periphery of the circular base. An iris design is printed on the lens. Each flap has an attachment end that is coupled to a portion of the corneal implant and a suture end that can be sutured to ocular tissue.

[0006] Embodiments may include none, one, some, or all of the following features. * The attachment end is bonded to the periphery of the circular base or to the peripheral portion of the ring. The flap has one or more drainage channels, each capable of transferring fluid between the attached end and the sewn end.

[0007] In certain embodiments, the corneal implant includes a transparent dome, a ring, an iris component, and a lens. The transparent dome has a circular base with a periphery having a diameter of less than 2 centimeters. The transparent dome includes a transparent biocompatible material. The ring has an annular shape and is disposed around the periphery of the circular base of the transparent dome. The ring includes a biocompatible material having a surface. A peripheral portion of the surface forms openings that promote attachment of ocular tissue to the ring. Each opening has a diameter of less than 2 millimeters. The iris component is disposed outward from the circular base of the transparent dome and substantially centered within the periphery of the circular base. The lens is disposed outward from the iris component and substantially centered with the iris component.

[0008] Implementations can include the following features. The corneal implant includes one or more flaps. Each flap has an attachment end, a suture end, and one or more drainage channels. The attachment end can be attached to the periphery of the circular base or the peripheral portion of the ring. The suture end can be sutured to ocular tissue. Each channel can transfer fluid between the attachment end and the suture end. [Brief explanation of the drawings]

[0009] [Figure 1] 1 illustrates an example of a corneal implant that may be implanted in a patient's eye, according to certain embodiments. [Figure 2] 1 illustrates an example of a corneal implant with a lens and an iris, according to certain embodiments. [Figure 3A-3B] 1 illustrates an example of a corneal implant with a porous surface, according to certain embodiments. [Figure 4A-4B] 1 illustrates an example of a corneal implant with one or more flaps that may be used to attach the implant to the eye, according to certain embodiments. [Figure 5] 1 shows a diagram of an example of a method for implanting an implant in an eye, according to certain embodiments. DETAILED DESCRIPTION OF THE INVENTION

[0010]

[0013] Referring now to the description and drawings, exemplary embodiments of the disclosed apparatus, systems, and methods are shown in detail. This description and drawings are not intended to be exhaustive, and are not intended to limit the claims to the specific embodiments shown and disclosed herein. While the drawings represent possible embodiments, the drawings are not necessarily to scale, and certain features may be simplified, exaggerated, omitted, or partially separated to more clearly illustrate the embodiments.

[0011] Donor corneal tissue transplanted into a patient's eye carries the risk of rejection by the patient's immune system. To address this issue, embodiments of corneal implants described herein include a ring that includes a biocompatible material and has a surface that improves implantation. For example, the surface can be porous to facilitate adhesion of the implant to surrounding tissue, such as the trabecular meshwork. Additional features are described in more detail below.

[0012] 1 illustrates an example of a corneal implant 10 that may be implanted in a patient's eye according to certain embodiments. In this example, implant 10 includes a transparent dome 20 and a ring 22 joined together as shown. Transparent dome 20 has a circular base 22 with a perimeter 24 having a diameter of less than 2 centimeters (cm), for example, in the range of 7 millimeters (mm) to 18 millimeters (mm). Transparent dome 20 comprises a transparent biocompatible material, such as acrylic, silicone, or any material commonly used in intraocular lenses (IOLs).

[0013] In certain embodiments, the shape of dome 20 is determined according to the desired refractive properties of dome 20. For example, dome 20 may be required to have the refractive properties of the natural cornea (or other suitable refractive properties) to provide optimal vision. Given the refractive index of the material of dome 20, the shape can be calculated using, for example, ray tracing techniques or intraocular lens (IOL) calculation techniques.

[0014] The ring 22 has an annular shape and is disposed around the periphery 24 of the circular base 22. The ring 22 comprises a hard biocompatible material, such as a biocompatible metal (e.g., surgical steel or titanium) or a biocompatible plastic (e.g., hard acrylic or silicone) having a high Shore hardness (e.g., a Shore D value of 30 or greater). A peripheral portion 30 of the ring 22 generally represents the outer portion of the ring 22 that contacts the cornea or other ocular tissue. The surface of the ring 22 forms openings 32, each having a diameter of less than 1 or 2 millimeters. In certain embodiments, there are at least 20, 25, 50, or 100 openings 32. The openings 32 may form a porous surface or an artificial trabecular meshwork that mimics the structure of the eye's natural trabecular meshwork.

[0015] 2 shows an example of a corneal implant 10 including a lens 40 and an iris 42, according to certain embodiments. In this example, the lens 40 is disposed outwardly from the periphery of the circular base 22 of the transparent dome 20 and substantially centered within the periphery. The lens comprises a transparent, biocompatible material (as described above with reference to the transparent dome 20). The shape of the lens 40 can be designed according to the desired refractive properties of the lens 40 (as described above with reference to the transparent dome 20).

[0016] The iris 42 may have a size, shape, and color that matches the size, shape, and color of the patient's other eye. The iris 42 may have any suitable form. In certain embodiments, the iris 42 may be an iris design (i.e., a design that looks like a natural iris) printed onto the lens 40 by a printer, such as an inkjet printer. In other embodiments, the iris 42 may be formed as a separate component that can be positioned between the lens 40 and the dome 20 and mechanically or chemically bonded to it. In embodiments, the iris component may be an iris design printed on a substrate comprising a biocompatible material, such as a transparent biocompatible material.

[0017] 3A and 3B show an example of a corneal implant 10 having a porous surface designed to encourage the growth of surrounding tissue, according to certain embodiments. A peripheral portion (or smaller or larger portion) of the ring 22 has a surface with openings 32. The openings 32 may open into the hollow interior of the ring 22 or may be deep depressions in the ring 22. The openings 32 facilitate adhesion of the implant 10 to surrounding tissue, such as the natural trabecular meshwork. The natural trabecular meshwork is a complex, fenestrated, three-dimensional structure located within the iridocorneal angle. The trabecular meshwork acts to drain aqueous humor (AH) from the eye and regulate the eye's intraocular pressure (IOP).

[0018] In certain embodiments, the openings 32 form a porous surface having any suitable number of pores of any suitable size, for example, pores having diameters of less than 1 or 2 millimeters, e.g., in the range of 20 to 50 microns, and pores having a volume of less than 1 square centimeter (cm 2 The openings 32 may have a density of at least 20 pores per square centimeter, e.g., 50-100 pores per square centimeter. The pores may be arranged in any suitable pattern, such as a circle-packing pattern, a triangle, a square, or a hexagonal-packing pattern. In some embodiments, the openings 32 form an artificial trabecular meshwork that mimics the structure of the eye's natural trabecular meshwork.

[0019] 4A and 4B show an example of a corneal implant 10 having one or more flaps 50 that may be used to attach the implant 10 to the eye, according to certain embodiments. The flaps 50 may attach the implant 20 to the eye in any suitable manner. For example, the flaps 50 may be sutured to the eye. The sutures may be placed under the conjunctiva to avoid causing discomfort.

[0020] The implant 10 may have any suitable number of flaps 50, such as one, two, three, four, or more flaps 50, positioned outward from the periphery of the circular base of the dome 20 and / or from the peripheral portion of the ring 22. The flaps 50 may comprise a biocompatible material, such as a flexible biocompatible plastic having a Shore A hardness of 80 or less. The flaps 50 may have any suitable size and shape. For example, the flaps 50 may have attachment ends shaped to conform to the portion of the dome 20 or ring 22 to which they are attached. The flaps 50 may have shaped sutured ends, such as rounded ends, to avoid causing discomfort. In certain embodiments, the flaps 50 may have channels between the attachment and sutured ends through which fluid can escape to control IOP. The flaps 50 may have any suitable number of channels, such as 1 to 10 channels, and the channels may have any suitable diameter, such as less than 1 or 2 millimeters.

[0021] FIG. 5 shows a diagram 60 of an example of a method for implanting an implant 10 within an eye 12, according to certain embodiments. In this example, diseased corneal tissue 14 is removed from the eye 12, leaving a space within the remaining tissue. The implant 10 is inserted into the space from which the tissue 14 was removed. The edges of the implant 10 may be placed under a residual ring of remaining corneal or other ocular tissue to provide a smooth transition from the sclera to the cornea. In certain embodiments, the implant 10 may be sutured into place, for example, by suturing a suture flap (not shown) of the implant 10 to the remaining tissue. The flap may be guided through the natural trabecular meshwork, and the sutures may be placed under the conjunctiva to avoid causing discomfort.

[0022] While the present disclosure has been described with respect to particular embodiments, modifications of the embodiments (such as changes, substitutions, additions, omissions, and / or other modifications) will be apparent to those skilled in the art. Accordingly, changes may be made to these embodiments without departing from the scope of the invention. For example, changes may be made to the systems and devices disclosed herein. As will be apparent to those skilled in the art, the elements of the systems and devices may be integrated or separate, and the operations of the systems and devices may be performed by more, fewer, or other elements. As another example, changes may be made to the methods disclosed herein. These methods may include more, fewer, or other steps, and these steps may be performed in any suitable order, as will be apparent to those skilled in the art.

[0023] To assist the Patent Office and the reader in interpreting the claims, applicants note that no claim or claim element is intended to invoke 35 U.S.C. §112(f) unless the terms "means for" or "step for" are expressly used in a particular claim. Use of any other term in the claims (e.g., "mechanism," "module," "device," "unit," "component," "element," "member," "apparatus," "machine," "system," "processor," or "controller") is understood by applicants to refer to structures known to those skilled in the art and, therefore, is not intended to invoke 35 U.S.C. §112(f).

Claims

1. A corneal implant, the corneal implant comprising: a transparent dome having a circular base, the periphery of the circular base having a diameter of less than 2 centimeters, the transparent dome comprising a transparent biocompatible material; a ring having an annular shape and disposed around the periphery of the circular base of the transparent dome, the ring comprising a biocompatible material having a surface, a peripheral portion of the surface forming a plurality of openings, each opening having a diameter of less than 2 millimeters, the plurality of openings promoting attachment of ocular tissue to the ring; A corneal implant comprising:

2. The corneal implant of claim 1 , wherein the biocompatible material comprises a biocompatible metal.

3. The corneal implant of claim 1 , wherein the biocompatible material comprises a biocompatible plastic.

4. The corneal implant of claim 1 , wherein the plurality of openings has a density of at least 20 openings per square centimeter.

5. The corneal implant of claim 1 , wherein each opening has a diameter of less than 1 millimeter.

6. The corneal implant of claim 1 , wherein the plurality of openings are arranged in a circle-filling pattern.

7. The corneal implant of claim 1 , wherein the plurality of openings form an artificial trabecular meshwork.

8. 10. The corneal implant of claim 1, further comprising a lens disposed outwardly from the circular base of the transparent dome and substantially centered within the periphery of the circular base of the transparent dome.

9. The corneal implant of claim 8 , further comprising an iris design printed on the lens.

10. 10. The corneal implant of claim 1, further comprising an iris component disposed outwardly from the circular base of the transparent dome and substantially centered within the periphery of the circular base of the transparent dome.

11. The corneal implant of claim 10 , wherein a lens is positioned outwardly from and substantially centered with the iris component.

12. Further comprising one or more flaps, each flap comprising: an attachment end configured to couple to a portion of the corneal implant; a suture end configured to be sutured to the ocular tissue; The corneal implant of claim 1 , comprising:

13. The corneal implant of claim 12 , wherein the attachment end is coupled to the periphery of the circular base.

14. The corneal implant of claim 12 , wherein the attachment end is coupled to the peripheral portion of the ring.

15. The corneal implant of claim 12 , wherein the flap includes one or more drainage channels, each configured to transfer fluid between the attachment end and the suture end.

16. A corneal implant, the corneal implant comprising: a transparent dome having a circular base, the periphery of the circular base having a diameter of less than 2 centimeters, the transparent dome comprising a transparent biocompatible material; a ring having an annular shape and disposed around the periphery of the circular base of the transparent dome, the ring comprising a biocompatible material having a surface, a peripheral portion of the surface forming a plurality of openings, each opening having a diameter of less than 2 millimeters, the plurality of openings promoting attachment of ocular tissue to the ring; a lens disposed outwardly from the circular base of the transparent dome and substantially centered within the periphery of the circular base of the transparent dome, the lens having an iris design printed thereon; and One or more flaps, each flap comprising: an attachment end configured to couple to a portion of the corneal implant; a suture end configured to be sutured to the ocular tissue; one or more flaps comprising: A corneal implant comprising:

17. 17. The corneal implant of claim 16, wherein the attachment end is coupled to the periphery of the circular base or the peripheral portion of the ring.

18. 17. The corneal implant of claim 16, wherein the flap includes one or more drainage channels, each channel configured to transfer fluid between the attachment end and the suture end.

19. A corneal implant, the corneal implant comprising: a transparent dome having a circular base, the periphery of the circular base having a diameter of less than 2 centimeters, the transparent dome comprising a transparent biocompatible material; a ring having an annular shape and disposed around the periphery of the circular base of the transparent dome, the ring comprising a biocompatible material having a surface, a peripheral portion of the surface forming a plurality of openings, each opening having a diameter of less than 2 millimeters, the plurality of openings promoting attachment of ocular tissue to the ring; an iris component disposed outwardly from the circular base of the transparent dome and substantially centered within the periphery of the circular base of the transparent dome; a lens disposed outwardly from and substantially centered with said iris component; A corneal implant comprising:

20. Further comprising one or more flaps, each flap comprising: an attachment end configured to couple to a portion of the corneal implant, the attachment end being coupled to the periphery of the circular base or the peripheral portion of the ring; a suture end configured to be sutured to the ocular tissue; one or more exhaust channels, each channel configured to transfer fluid between the attachment end and the suture end; 20. The corneal implant of claim 19, comprising:

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