This disclosure is generally directed to ocular implants. More specifically, this disclosure is directed to a scleral prosthesis having one or more serrated or other surfaces for retention in scleral tissue for treating presbyopia and other eye disorders.
Presbyopia is a condition that causes a person to slowly lose the ability to focus his or her eyes on objects close to the person. As a result, the person comes to need glasses for tasks requiring near vision, such as reading. Presbyopia is observed in many people over the age of forty. While the conventional view was that presbyopia could not be treated, recent advances have shown that presbyopia can be treated by implanting scleral prostheses within tunnels formed through the sclera of a patient's eye.
This disclosure provides a scleral prosthesis having one or more serrated or other surfaces for retention in scleral tissue for treating presbyopia and other eye disorders.
In a first embodiment, a scleral prosthesis includes an elongated body configured to be implanted into scleral tissue of an eye. The elongated body includes opposing first and second free ends and at least one serrated or textured surface between the first and second free ends. The at least one serrated or textured surface is configured to allow sliding of the elongated body within the scleral tissue in a first direction and to resist sliding of the elongated body within the scleral tissue in a second direction opposite to the first direction.
In particular embodiments, any single one or any combination of the following features could be used with the first embodiment. The elongated body could include a top surface extending from the first free end to the second free end and a bottom surface extending from the first free end to the second free end. The at least one serrated or textured surface could include the bottom surface. At least part of the top surface could be convex, and at least part of the bottom surface could be planar. The scleral prosthesis could further include an opening through the first end, where the opening is configured to be grasped by a surgical tool. The elongated body could be linear and could have a substantially equal width along its length. The at least one serrated or textured surface could include multiple grooves forming multiple angled projections. The grooves and the angled projections could extend substantially across an entire width of the elongated body. The elongated body could be configured to be implanted lengthwise into the scleral tissue of the eye. A thickness of the elongated body could taper towards the first and second ends.
In a second embodiment, a method includes forming an elongated body of a scleral prosthesis that is configured to be implanted into scleral tissue of an eye. The elongated body includes opposing first and second free ends and at least one serrated or textured surface between the first and second free ends. The at least one serrated or textured surface is configured to allow sliding of the elongated body within the scleral tissue in a first direction and to resist sliding of the elongated body within the scleral tissue in a second direction opposite to the first direction.
In particular embodiments, any single one or any combination of the following features could be used with the second embodiment. The elongated body could include a top surface extending from the first free end to the second free end and a bottom surface extending from the first free end to the second free end. The at least one serrated or textured surface could include the bottom surface. At least part of the top surface could be convex, and at least part of the bottom surface could be planar. The method could further include forming an opening through the first end, where the opening is configured to be grasped by a surgical tool. The elongated body could be linear and could have a substantially equal width along its length. The at least one serrated or textured surface could include multiple grooves forming multiple angled projections. The grooves and the angled projections could extend substantially across an entire width of the elongated body. The elongated body could be configured to be implanted lengthwise into the scleral tissue of the eye. A thickness of the elongated body could taper towards the first and second ends.
In a third embodiment, a scleral prosthesis includes an elongated body configured to be implanted into scleral tissue of an eye. The elongated body includes opposing first and second free ends and at least one serrated or textured surface between the first and second free ends. The scleral prosthesis also includes an opening through the first end, where the opening is configured to be grasped by a surgical tool. The at least one serrated or textured surface is configured to allow sliding of the elongated body within the scleral tissue in a first direction and to resist sliding of the elongated body within the scleral tissue in a second direction opposite to the first direction. The elongated body includes a top surface extending from the first free end to the second free end and a bottom surface extending from the first free end to the second free end. At least part of the top surface is convex, and at least part of the bottom surface is planar. The at least one serrated or textured surface includes multiple grooves forming multiple angled projections. A thickness of the elongated body tapers towards the first and second ends.
Other technical features may be readily apparent to one skilled in the art from the following figures, descriptions, and claims.
For a more complete understanding of this disclosure, reference is now made to the following description, taken in conjunction with the accompanying drawing, in which:
As shown in
In this example, the scleral prosthesis 100 has a generally linear shape, meaning the elongated body is generally straight and has a substantially equal width along its entire length. Note, however, that the elongated body could have any other suitable shape, such as an hourglass shape, an “I” shape, an “X” shape, or a “T” shape. In some cases, one or both ends 102 and 104 of the elongated body could be wider than a remaining portion of the elongated body between the ends 102 and 104. One or both ends 102 and 104 of the elongated body could also or alternatively be split, meaning that one or both ends 102 and 104 each includes divided portions of the elongated body that are separated by empty space to form that end. The divided portions could be pushed towards each other, such as to reduce the width of at least one end of the elongated body during implantation, and the divided portions could expand again once released. Optionally, an insert could be placed into the empty space to maintain separation of the divided portions of the elongated body, such as after implantation.
In the example shown in
The sides 110 generally extend between the top and bottom surfaces 106 and 108 of the elongated body. In the example shown in
Various prior scleral prostheses (such as those disclosed in U.S. Pat. No. 9,498,324, which is hereby incorporated by reference in its entirety) were often described as being inserted into scleral tunnels of patients' eyes. A scleral tunnel denotes a passageway that both extends into and out of scleral tissue, meaning there are two incisions on the surface of a patient's eye for each tunnel. Also, each of those scleral prostheses was often described as having its two opposing ends remain outside a scleral tunnel after implantation. Thus, one end of those scleral prostheses could be inserted through one incision on the surface of a patient's eye, travel through the scleral tunnel, and exit the patient's eye through the other incision on the surface of the patient's eye. While effective, this often requires the formation of multiple linked incisions per tunnel or the formation of a long single incision per tunnel in a patient's eye.
Rather than being inserted completely through a scleral tunnel, the scleral prosthesis 100 could be inserted into a scleral “cave” or “pocket,” which refers to an incision made into scleral tissue of an eye that ends within the scleral tissue and does not exit from the scleral tissue. As a result, there may be only a single incision on the surface of a patient's eye for each scleral cave, and that single incision could be smaller compared to an incision needed to form a scleral tunnel. Most or all of the scleral prosthesis 100 could then be inserted into a scleral cave in order to treat presbyopia or other eye disorders. When implanted in this manner, the entire scleral prosthesis 100 may be hidden within the patient's scleral tissue, or only a small portion (such as a single end) of the scleral prosthesis 100 may be visible. This can help to increase the cosmetic appeal of a medical treatment that uses the scleral prosthesis 100. Also, a scleral cave can be formed using a trans-conjunctival surgical procedure, meaning an incision is made through the conjunctiva of a patient's eye but not completely through the sclera of the patient's eye (as opposed to a trans-scleral surgical procedure that forms an incision through the sclera of the patient's eye). A trans-conjunctival surgical procedure could be simpler and faster than a trans-scleral surgical procedure and result in fewer injuries that require healing while reducing surgical risks.
Moreover, as described below, at least one surface of the scleral prosthesis 100 can be serrated or otherwise textured. The serrated or other textured surface(s) of the scleral prosthesis 100 can permit the scleral prosthesis 100 to slide in one direction and can resist movement of the scleral prosthesis 100 in the opposite direction. During implantation, one end 102 of the scleral prosthesis 100 can be pushed into a scleral cave, followed by the remainder of the scleral prosthesis 100. The serrated or other textured surface(s) of the scleral prosthesis 100 can allow this movement of the scleral prosthesis 100 into the scleral cave. However, the serrated or other textured surface(s) of the scleral prosthesis 100 can prevent the backward movement of the scleral prosthesis 100 out of the scleral cave. This helps to secure the scleral prosthesis 100 in a desired position within the patient's eye.
In addition, the scleral prosthesis 100 can include an opening 112 at one or both ends 102 and 104 of the scleral prosthesis 100. After implantation in a patient's eye, if the scleral prosthesis 100 needs to be removed, an incision can be made through the conjunctiva and sclera of the patient's eye to expose one end 102 or 104 of the scleral prosthesis 100. A tool could be inserted into the opening 112 by a surgeon or other personnel, and the scleral prosthesis 100 can be pulled or pushed to remove the scleral prosthesis 100 from the scleral cave. The serrated or other textured surface(s) of the scleral prosthesis 100 can allow this movement out of the scleral cave. Note that while a single opening 112 on one end 102 of the scleral prosthesis 100 is shown here, one or more openings 112 could exist at one or both ends 102 and 104 of the scleral prosthesis 100. Multiple openings 112 could be useful, for instance, so that the scleral prosthesis 100 can be removed using any exposed opening 112.
The scleral cave in which a scleral prosthesis 100 is implanted can be formed near the ciliary body of a patient's eye. Once implanted in a scleral cave, the scleral prosthesis 100 helps to, for example, increase the amplitude of accommodation of the patient's eye, which means that the scleral prosthesis 100 can help improve the ability of the patient's eye to focus on nearby objects. The scleral prosthesis 100 can therefore help to treat or reverse presbyopia in the patient. The scleral prosthesis 100 could also help to treat other eye conditions, such as glaucoma, ocular hypertension, elevated intraocular pressure, or other eye disorders. In some embodiments, multiple scleral prostheses 100 are implanted in a patient's eye, such as when four scleral prostheses 100 are implanted in four quadrants of the patient's eye (like at 45°, 135°, 225°, and 315°). Also, the ends of the scleral prostheses 100 are “free,” meaning the ends 102 and 104 of one scleral prosthesis 100 are not attached to the ends 102 and 104 of other scleral prostheses 100.
The scleral cave in which a scleral prosthesis 100 is implanted can also be formed in any suitable manner. For example, various surgical tools for forming scleral tunnels are disclosed in U.S. Pat. No. 7,189,248; U.S. Pat. No. 8,083,759; and U.S. Pat. No. 8,597,318 (which are hereby incorporated by reference in their entirety). Any of these surgical tools could be configured to form a scleral cave, such as by partially rotating or otherwise moving a curved blade or other surgical blade so that the tip of the blade enters into the patient's scleral tissue but does not travel completely through the patient's scleral tissue and form a tunnel. The surgical blade would therefore form a scleral cave based on a single incision in the patient's eye, rather than a scleral tunnel. Also, the surgical tool used to form the scleral caves could be used in conjunction with a docking station or ocular fixation device, such as those disclosed in U.S. Pat. No. 8,709,029 and U.S. Patent Publication No. 2012/0226107 (which are hereby incorporated by reference in their entirety).
The scleral prosthesis 100 could have any suitable size, shape, and dimensions. In some embodiments, the scleral prosthesis 100 could have a length of about 4.5 millimeters and a width of about 1.25 millimeters, and the opening 112 could have a diameter of about 0.125 millimeters. However, other dimensions could be used. Also, scleral prostheses 100 of different sizes could be provided, such as for use with eyes of different sizes or for different medical treatments or surgical procedures. Further, the scleral prosthesis 100 could be formed from any suitable material(s). For example, the scleral prosthesis 100 may be formed using polymethyl methacrylate (“PMMA”), polyether-ether ketone (“PEEK”), or other suitable material(s). In addition, the scleral prosthesis 100 could be formed in any suitable manner, such as via injection molding, machining, or additive manufacturing (such as “3D printing”).
A serrated or other textured bottom surface of the scleral prosthesis 100 is shown in
Any suitable dimensions could be used with the serrations or other texturing. In some embodiments, each groove 602 could have a width 606 of about 0.05 millimeters and a height 608 of about 0.031 millimeters, and a top of each groove 602 could have a radius of curvature 610 of about 0.01 millimeters. There could also be a separation 612 of about 0.01 millimeters between adjacent grooves 602. Note, however, that this shape and these dimensions are examples only and that other shapes and dimensions could be used.
The ability to restrict movement in one or more directions can vary based on the design of the serrations or other texturing. For example, in
In the example of the scleral prosthesis 100 shown in
Although
As shown in
One or more openings are formed through one or more ends of the elongated body at step 706. This could include, for example, forming one or more openings 112 in one end 102 of the elongated body or forming openings 112 in both ends 102 and 104 of the elongated body. As particular examples, this could include drilling through the elongated body to form the opening(s) 112 or forming the opening(s) 112 while forming the elongated body. Formation of the scleral prosthesis is completed at step 708. This could include, for example, polishing the surfaces of the elongated body, sterilizing the elongated body, or performing any other or additional actions to form a completed scleral prosthesis.
Although
As shown in
A scleral prosthesis is inserted in a first direction into the scleral cave in the patient's eye at step 804. This could include, for example, inserting the elongated body of the scleral prosthesis 100 lengthwise into the scleral cave. The first direction denotes a direction in which the serrations or other texturing of the scleral prosthesis 100 permits or allows sliding or other movement of the scleral prosthesis 100. A surgical procedure is completed at step 806. This could include, for example, performing any other actions to complete a surgical procedure for treating presbyopia or other eye disorders. Once implanted in this manner, the serrations or other texturing of the scleral prosthesis resists movement of the scleral prosthesis in a second direction opposite to the first direction at step 808. The second direction denotes a direction in which the serrations or other texturing of the scleral prosthesis 100 restricts sliding or other movement of the scleral prosthesis 100.
It may become necessary or desirable at some point to remove the scleral prosthesis at step 810. This may occur, for example, if a surgical complication or other complication associated with the scleral prosthesis 100 arises. This may also occur if there is a need to replace the scleral prosthesis 100 with another scleral prosthesis. If this condition arises, an incision is formed in the ocular tissue of the patient's eye to expose at least part of the scleral prosthesis at step 812. This could include, for example, forming an incision near the end 102 of the scleral prosthesis 100 and revealing an opening 112 of the scleral prosthesis 100. The scleral prosthesis is moved in the first direction out of the scleral cave in the patient's eye at step 814. This could include, for example, a surgeon or other personnel grabbing the opening 112 of the scleral prosthesis 100 using a surgical tool and pulling the scleral prosthesis 100 out of the scleral cave.
Although
It may be advantageous to set forth definitions of certain words and phrases used throughout this patent document. The terms “include” and “comprise,” as well as derivatives thereof, mean inclusion without limitation. The term “or” is inclusive, meaning and/or. The phrase “associated with,” as well as derivatives thereof, may mean to include, be included within, interconnect with, contain, be contained within, connect to or with, couple to or with, be communicable with, cooperate with, interleave, juxtapose, be proximate to, be bound to or with, have, have a property of, have a relationship to or with, or the like. The phrase “at least one of,” when used with a list of items, means that different combinations of one or more of the listed items may be used, and only one item in the list may be needed. For example, “at least one of: A, B, and C” includes any of the following combinations: A, B, C, A and B, A and C, B and C, and A and B and C.
The description in this patent document should not be read as implying that any particular element, step, or function is an essential or critical element that must be included in the claim scope. Also, none of the claims is intended to invoke 35 U.S.C. § 112(f) with respect to any of the appended claims or claim elements unless the exact words “means for” or “step for” are explicitly used in the particular claim, followed by a participle phrase identifying a function. Use of terms such as (but not limited to) “mechanism,” “module,” “device,” “unit,” “component,” “element,” “member,” “apparatus,” “machine,” “system,” “processor,” “processing device,” or “controller” within a claim is understood and intended to refer to structures known to those skilled in the relevant art, as further modified or enhanced by the features of the claims themselves, and is not intended to invoke 35 U.S.C. § 112(f).
While this disclosure has described certain embodiments and generally associated methods, alterations and permutations of these embodiments and methods will be apparent to those skilled in the art. Accordingly, the above description of example embodiments does not define or constrain this disclosure. Other changes, substitutions, and alterations are also possible without departing from the spirit and scope of this disclosure, as defined by the following claims.
This application claims priority under 35 U.S.C. § 119(e) to U.S. Provisional Patent Application No. 62/438,700 filed on Dec. 23, 2016. This provisional application is hereby incorporated by reference in its entirety.
Number | Date | Country | |
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62438700 | Dec 2016 | US |