SHAPED CORNEAL SEGMENTS: CORNEAL ALLOGENIC INTRA-STROMAL DEVICES (RING SEGMENTS AND RINGS, MODIFIED DISCS, MODIFICATIONS) FOR INDUCING SHAPE CHANGE, REGULARIZATION AND STABILIZATION OF CORNEA IN CORNEAL ECTASIA AND OTHER CORNEAL CONDITIOINS AND FOR CORRECTION OF REFRACTIVE ERRORS

Abstract

A device for implantation into the cornea intra-stromally comprising allogenic comeal or scleral material or other bioengineered material including, but not limited to, processed collagen tissues, comprises a segment that is inserted into a comeal channel whereby the segment regularizes the conical cornea, gives an improved surface, improves biomechanical strength distribution and stability improves optical functionality, and improves/corrects the refractive error or gives other desired shape change effects.

Claims

1-22. (canceled)

23. An implant for implantation into the cornea intra-stromally into a corneal channel or plane that comprises allogenic corneal or scleral material or other bioengineered material including but not limited to processed collagen wherein: said implant is in the form of segment, ring or modified disc, either used as such or further modified through a variety of different ways, including but not confined to collagen crosslinking, chemical/thermal/biological/laser modification, gamma radiation, and/or cryopreservation, so as to modify shape, regional thickness variability, strength, stiffness, rigidity, safety, storage capabilities, drug elution and/or vector capabilities of the implant; said implant changes or modifies among other characteristics, the shape and regularity of the patient's cornea, regularizes the conical cornea, gives an improved surface, improves biomechanical strength distribution and stability, improves optical functionality and improves/corrects the refractive error or gives other desired shape change effects; said implant may be of varying geometry, varying regional thickness, varying thickness or geometry in any dimension or region, varying cross-sectional architecture, varying sizes in any dimension, varying radius and diameter and varying arc and/or chord length, and may be oval, rectangular, hexagonal, triangular, or other shape in cross-section and may have storage capabilities, drug elution and/or vector capabilities.

24. The implant of claim 23, further characterized: in being a segment that is inserted into a corneal channel in order to obtain said desired effects; said segment implant may be of varying geometry, varying regional thickness, varying thickness in any dimension, varying cross-sectional architecture, varying size in any dimension, varying radius and diameter, and varying arc and/or chord length, and may be oval, rectangular, hexagonal, triangular, or other shape in cross-section.

25. The implant of claim 23, further characterized: in being an elongated segment that is inserted into a corneal channel in order to obtain said desired effects; said elongated segment implant may be of varying geometry, varying regional thickness, varying thickness in any dimension, varying cross-sectional architecture, varying size in any dimension, varying radius and diameter, and varying arc and/or chord length, and may be oval, rectangular, hexagonal, triangular or other shape in cross-section.

26. The implant of claim 23, further characterized: in being a ring that is inserted into a corneal channel or plane in order to obtain said desired effects; said ring implant may be of varying geometry, varying regional thickness, varying thickness in any dimension, varying cross-sectional architecture, varying size in any dimension, varying radius and diameter, and varying arc and/or chord length, and may be oval, rectangular, hexagonal, triangular, or other shape in cross-section.

27. The implant of claim 23, further characterized: in being a modified disc that is inserted into a corneal channel or plane in order to obtain said desired effects; said modified disc implants may have regional variations in its geometry or thickness and may be of varying geometry, varying regional thickness, varying thickness in any dimension or region, varying cross-sectional architecture, varying sizes in any dimension, and varying radius and diameter.

28. The implant of claim 23, further characterized: in being a segment, an elongated segment, a ring, or a modified disc that is further modified through a variety of different ways including but not confined to collagen crosslinking, chemical/thermal/biological/laser modification, gamma radiation, cryopreservation, so as to modify the shape, regional thickness variability, strength, stiffness, rigidity, safety, storage capabilities, drug elution or vector capabilities, said segment, elongated segment, ring, or modified disc implanted into a corneal channel or plane to obtain said desired effects; said modified implants may have regional variations in its geometry or thickness, and may be of varying geometry, varying regional thickness, varying thickness in any dimension or region, varying cross-sectional architecture, varying size in any dimension, varying radius and diameter, and varying arc and/or chord length, and may be oval, rectangular, hexagonal, triangular, or any other shape in cross-section.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0007] Referring now to the drawings wherein the showings are for the purpose of illustrating preferred embodiment of the inventions only, and not for the purpose of limiting the same.

[0008] FIG. 1A: The design of an allogenic or bioengineered segment device is shown. Different parts of the segment are labelled (a—ends of the segment; b—body of the segment).

[0009] FIG. 1B: The segment is seen with reference to a human eye. The diagram shows the human cornea (a). The segment is seen ready for implantation (b). A channel (c) has been prepared either manually or using a mechanized instrument or the femtosecond laser or any other means in the cornea of the subject (a).

[0010] FIG. 1C: One segment (b1) is implanted into the channel (c) in the cornea of the subject (a). It now lies within the cornea inducing shape change, regularizing the conical cornea, giving an improved surface, improving biomechanical strength distribution and stability, improving optical functionality and improving/correcting the refractive error.

[0011] FIG. 1D: Another segment (b2) has been implanted in the opposite axis within the channel (c). Both segments (b1, b2) now lie within the cornea (a) inducing shape change, regularizing the conical cornea, giving an improved surface, improving biomechanical strength distribution and stability, improving optical functionality and improving/correcting the refractive error.

[0012] FIG. 2A: The design of an allogenic or bioengineered elongated segment device is shown. Different parts of the segment are labelled (a—ends of the segment; b—body of the segment).

[0013] FIG. 2B: The elongated segment is seen with reference to a human eye. The diagram shows the human cornea (a). The segment is seen ready for implantation (b). A channel (c) has been prepared either manually or using a mechanized instrument or the femtosecond laser or any other means in the cornea of the subject (a).

[0014] FIG. 2C: The elongated segment (b) is implanted into the channel (c) in the cornea (a). It now lies within the cornea inducing shape change, regularizing the conical cornea, giving an improved surface, improving biomechanical strength distribution and stability, improving optical functionality and improving/correcting the refractive error.

[0015] FIG. 3A: The design of an allogenic or bioengineered ring device is shown.

[0016] FIG. 3B: The ring is seen with reference to a human eye. The diagram shows the human cornea (a). The ring is seen ready for implantation (b). The plane for implantation (c) has been prepared either manually or using a mechanized instrument or the femtosecond laser or any other means in the cornea of the subject (a).

[0017] FIG. 3C: The ring (b) is implanted into the plane (c) in the cornea (a). It now lies within the cornea inducing shape change, regularizing the conical cornea, giving an improved surface, improving biomechanical strength distribution and stability, improving optical functionality and improving/correcting the refractive error.

[0018] FIG. 4A: The design of a modified allogenic or bioengineered disc device (a) is shown. Modified parts of the disc are labelled (b—modified area of the disc).

[0019] FIG. 4B: The disc is seen with reference to a human eye. The diagram shows the human cornea (a). The disc is seen ready for implantation (b). The plane for implantation (c) has been prepared either manually or using a mechanized instrument or the femtosecond laser or any other means in the cornea of the subject (a):

[0020] FIG. 4C: The disc (b) is implanted into the plane (c) in the cornea (a). It now lies within the cornea inducing shape change, regularizing the conical cornea, giving an improved surface, improving biomechanical strength distribution and stability, improving optical functionality and improving/correcting the refractive error.

[0021] FIG. 5A: The segment device (a1), elongated segment device (a2), ring device (a3), modified disc device (a4) or other variations in shape, thickness, size, length, diameter, or cross-sectional architecture of these are processed (b) to modify for shape, regional thickness variability, strength, rigidity, stiffness, safety, storage capabilities, drug elution or vector capabilities etc using a variety of different ways including but not confined to collagen crosslinking, chemical/thermal/biological/laser modification, gamma radiation, cryopreservation and so on.

[0022] FIG. 5B: The processed segment device (b1), elongated segment device (b2), ring device (b3), modified disc device (b4) or other variations of these are implanted into the cornea (a). It now lies within the corneal channel/plane (c) inducing shape change, regularizing the conical cornea, giving an improved surface, improving biomechanical strength distribution and stability, improving optical functionality and improving/correcting the refractive error.

DETAILED DESCRIPTION OF THE INVENTION

[0023] “subject” as mentioned herein ‘any recipient of the corneal allogenic intra-stromal ring/segment devices described herein’

[0024] The present invention will be described herein below with reference to the accompanying drawings. The present invention provides induction of shape change, conical regularization, improved surface, optical improvement, refractive correction and biomechanical stability for use in corneal surgery in a subject.

Embodiment 1: Corneal Allogenic Intra-Stromal Ring Segment Design 1

[0025] The device is made of allogenic corneal or scleral material or other bioengineered material including but not limited to processed collagen (FIG. 1A). A ring segment of this tissue is created either manually or with a special trephine or femtosecond laser or any other means. It is then implanted into the eye. The said segment may be of varying geometry, varying thickness in any dimension, varying cross-sectional architecture, varying sizes in any dimension, varying radius and diameter and varying arc and/or chord length.

Embodiment 2: Corneal Allogenic Intra-Stromal Ring Segment Design 2

[0026] The device is made of allogenic corneal or scleral material or other bioengineered material including but not limited to processed collagen (FIG. 2A). An elongated ring segment of this tissue is created either manually or with a special trephine or femtosecond laser or any other means. It is then implanted into the eye. The said segment may be of varying geometry, varying thickness in any dimension, varying cross-sectional architecture, varying sizes in any dimension, varying radius and diameter and varying arc and/or chord length.

Embodiment 3: Corneal Allogenic Intra-Stromal Ring Design 3

[0027] The device is made of allogenic corneal or scleral material or other bioengineered material including but not limited to processed collagen (FIG. 3A). A ring shaped device of this tissue is created either manually or with a special trephine or femtosecond laser or any other means. It is then implanted into the eye. The said segment may be of varying geometry, varying thickness in any dimension, varying cross-sectional architecture, varying sizes in any dimension, varying radius and diameter and varying arc and/or chord length.

Embodiment 4: Modified Corneal Allogenic Intra-Stromal Devices (Modified Disc Segments)

[0028] The device is made of allogenic corneal or scleral material or other bioengineered material including but not limited to processed collagen (FIG. 4A). A disc shaped device of this tissue is created either manually or with a special trephine or femtosecond laser or any other means. It is then implanted into the eye. The modified disc has regional variations in its geometry or thickness. The said disc may be of varying geometry, varying thickness in any dimension, varying cross-sectional architecture, varying sizes in any dimension and varying radius and diameter.

Embodiment 5: Modified Corneal Allogenic Intra-Stromal Devices (Ring Segments, Rings and Modified Discs)

[0029] The device is made of different varieties of allogenic corneal or scleral material or other bioengineered material including but not limited to processed collagen. The intra-stromal device (ring segments, rings and modified discs) is further modified for shape, regional thickness variability, strength, stiffness, rigidity, safety, storage capabilities, drug elution or vector capabilities etc. This may be possible through a variety of different ways including but not confined to collagen crosslinking, chemical/thermal/biological/laser modification, gamma radiation, cryopreservation and so on. The said segment may be of varying geometry, varying thickness in any dimension, varying cross-sectional architecture, varying sizes in any dimension, varying radius and diameter and varying arc and/or chord length.

[0030] The foregoing description is for a few embodiments of the present invention. It should be appreciated that these embodiments are described for purpose of illustration only, and that numerous alterations and modifications may be practiced by those skilled in the art without departing from the spirit and scope of the invention. It is intended that all such modifications and alterations be included insofar as they come within the scope of the invention as claimed or the equivalents thereof.

[0031] Other modifications will be apparent to those skilled in the art and, therefore, the invention is defined in the claims.