Intracorneal optical implant

Abstract

1. A corneal implant for implantation within a cornea, the corneal implant defining a surface having (i) an inner platform portion (222) positioned about an axis of circular symmetry of the implant, (ii) a peripheral portion having one or more angularly spaced arms (204) extending laterally from a periphery of the inner platform, and (iii) a peripheral skirt portion defining a circular circumference of the implant, the one or more angularly spaced arms connecting between the inner platform and the peripheral skirt portion; and 2. a device (120) mounted on the inner platform portion and configured to project an image projection light beam posteriorly onto the retina of the eye based on the generated image.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of priority to U.S. Provisional Patent Application No. 63 / 245,384, entitled "INTRACORNEAL IMPLANT FOR PROJECTING IMAGES ONTO THE RETINA," filed September 17, 2021, and U.S. Provisional Patent Application No. 63 / 351,480, entitled "INTRACORNEAL OPTICAL IMPLANT," filed June 13, 2022, the contents of both of which are incorporated by reference in their entireties into this specification.

[0002]

[0002] The present invention relates to the field of ophthalmic devices and methods. [Background technology]

[0003]

[0003] The cornea is the transparent anterior portion of the eyeball that covers the iris, pupil, and anterior chamber. A healthy cornea acts as a transparent window allowing the entry of light through the lens, enabling the formation of an image on the retina.

[0004]

[0004] Corneal opacification can cause irreversible loss of its transparency, which can result in severe visual impairment. Corneal opacification can occur due to scarring from a variety of causes, including mechanical trauma, chemical injury, infection, and several other diseases of the cornea and ocular surface.

[0005]

[0005] Importantly, corneal opacification can cause blindness in otherwise healthy eyes. Despite the presence of complete corneal opacification, eyes with corneal blindness may retain a functional retina and intact intraocular visual pathway through the optic nerve. Even with severe visual impairment secondary to corneal disease, patients may still have significant potential visual acuity.

[0006]

[0006] Corneal transplantation is traditionally performed to replace irreversibly clouded corneas with corneal allografts. However, a significant number of cases are deemed ineligible for corneal transplantation due to the presence of high-risk features for allograft rejection and graft failure. To obviate the risk of allograft rejection, alternative surgical treatments such as artificial corneal implants and artificial keratoplasty have been developed, but such procedures can be associated with several complications, including device extrusion, retroprosthetic membrane formation, retinal detachment, and endophthalmitis. There is still no safe and effective surgical treatment for long-term vision rehabilitation in patients suffering from ocular trauma or burns, ocular infections, cicatricial keratoconjunctivitis, multiple failed corneal grafts, or significant corneal damage secondary to immune or ocular surface diseases.

[0007]

[0007] The foregoing examples of the related art and limitations associated therewith are intended to be illustrative and not exclusive. Other limitations of the related art will become apparent to those of ordinary skill in the art upon reading the specification and studying the drawings. Summary of the Invention

[0008]

[0008] The following embodiments and aspects thereof are described and illustrated in conjunction with systems, tools and methods that are for purposes of illustration and description, not limitation in scope.

[0009]

[0009] In one embodiment, there is provided a device comprising an intracorneal implant sized and adapted for implantation within the cornea of ​​an eye, the device comprising an intracorneal implant defining a planar body having a convex surface that substantially matches the convex surface of the cornea, the intracorneal implant comprising: (i) a central optic having an anterior end and an optical stem extending axially through the cornea to a posterior end, and (ii) a peripheral haptic portion having two or more angularly spaced haptics extending laterally from the central optic, the anterior end being located substantially on the anterior surface of the eye and the posterior end being in abutment or substantial contacting engagement with a thin layer of corneal tissue located posterior to the posterior end when the intracorneal implant is implanted within the cornea.

[0010]

[0010] In one embodiment, there is also provided an intracorneal implant sized and adapted for implantation within the cornea of ​​an eye, the intracorneal implant defining a planar body having a convex surface substantially matching the convex surface of the cornea, the intracorneal implant having (i) a central optic having an anterior end and an optical stem extending axially through the cornea to a posterior end, and (ii) a peripheral haptic portion having two or more angularly spaced haptics extending laterally from the central optic, and a method is provided comprising: implanting the intracorneal implant within the cornea so that the anterior end is located substantially on the anterior surface of the eye and the posterior end is in substantial contacting engagement with a thin layer of corneal tissue located posterior to the posterior end.

[0011]

[0011] In some embodiments, the optical stem is configured to project an image backwards, through a thin layer of corneal tissue, onto the retina of the eye.

[0012]

[0012] In some embodiments, the front end is a light receiving end and the optical stem defines a light transmissive pathway oriented to transmit light received at the front end from an extraocular light source through the optical stem, through a thin layer of corneal tissue and onto the retina of the eye.

[0013]

[0013] In some embodiments, the optical stem includes an image generator configured to receive image data signals from an extraocular source and project an image backwards, through a thin layer of corneal tissue, onto the retina of the eye.

[0014] In some embodiments, the optical stem comprises at least one optical lens.

[0015]

[0015] In some embodiments, the thin layer of corneal tissue is substantially transparent.

[0016] In some embodiments, the thin layer of corneal tissue has a thickness of about 10-50 μm.

[0017]

[0017] In some embodiments, the thin layer of corneal tissue includes, at least in its central portion, the pre-Descemet's layer and Descemet's membrane of the cornea.

[0018]

[0018] In some embodiments, the thin layer of corneal tissue further comprises Descemet's membrane of the cornea, at least in its central portion.

[0019]

[0019] In some embodiments, the thin layer of corneal tissue further comprises an endothelial layer of the cornea at least in its central portion.

[0020]

[0020] In some embodiments, the thin layer of corneal tissue is part of a corneal tissue scaffold configured for surgical implantation in the eye within a through recess formed by a full-thickness corneal perforation in the eye.

[0021]

[0021] In some embodiments, the thin layer of corneal tissue forms a central, substantially transparent region of the corneal tissue scaffold.

[0022]

[0022] In some embodiments, the corneal tissue scaffold is pretreated using at least one of the following techniques: dehydration, freeze-drying, plasticization, gelation, dehydration heat treatment, mechanical treatment, compression, and sterilization.

[0023]

[0023] In some embodiments, each of the haptics includes at least one opening configured to be used to facilitate fixation and adaptation of the device to corneal tissue when the device is implanted within the cornea.

[0024]

[0024] In some embodiments, when the intracorneal implant is implanted within the cornea, at least a portion of the leading end is exposed from the anterior surface of the eye.

[0025] In some embodiments, the front end is configured to mount at least one external optical element.

[0026] In some embodiments, the at least one external optical element is removably attached to the front end.

[0027]

[0027] In an embodiment, there is further provided an implantable corneal tissue scaffold device comprising: a central portion defining a recess having a posterior end including a thin layer of corneal tissue, the thin layer of corneal tissue comprising at least the pre-Descemet layer and Descemet's membrane, or at least the pre-Descemet layer; and a peripheral portion of corneal tissue surrounding the recess, the peripheral portion including one or more of a posterior layer of the corneal stroma, the pre-Descemet layer, Descemet's membrane, and an endothelial layer, wherein the implantable corneal tissue scaffold is made by: (i) performing a deep lamellar incision in the cornea separating the deep posterior stroma and the pre-Descemet layer, or the pre-Descemet layer and the Descemet's membrane, (ii) performing a partial drilling and removal of an anterior layer of the corneal stroma in the cornea, (iii) removing a central portion of the deep posterior stroma of the cornea to create the recess, and (iv) performing a full thickness drilling to remove the entire implantable corneal tissue scaffold device with the central and peripheral portions from the cornea.

[0028]

[0028] In one embodiment, there is further provided a method for making an implantable corneal tissue scaffold comprising a central portion defining a recess having a posterior end including a thin layer of corneal tissue, the thin layer of corneal tissue comprising at least the pre-Descemet's layer and Descemet's membrane, or at least the pre-Descemet's layer, and a peripheral portion of corneal tissue surrounding the recess, the peripheral portion comprising one or more of the posterior layer of the corneal stroma, the pre-Descemet's layer, Descemet's membrane, and the endothelial layer, by (i) performing a deep lamellar incision in the cornea separating the deep posterior corneal stroma and the pre-Descemet's layer, or the pre-Descemet's layer and the Descemet's membrane, (ii) performing a partial perforation and removal of the anterior layer of the corneal stroma in the cornea, (iii) removing a central portion of the deep posterior corneal stroma to create the recess, and (iv) performing a full thickness perforation to remove the entire implantable corneal tissue scaffold device comprising the central and peripheral portions from the cornea.

[0029] In some embodiments, the corneal tissue scaffold device has a diameter of 5-11 mm.

[0030] In some embodiments, the thin layer of corneal tissue has a thickness of 10-50 μm and the periphery has a thickness of 100-500 μm.

[0031]

[0031] In some embodiments, the thin layer of corneal tissue is substantially transparent.

[0032]

[0032] In some embodiments, the cornea is a donor cornea.

[0033] In some embodiments, the recess has a diameter of 3 to 7 mm.

[0034]

[0034] In some embodiments, deep laminar dissection is performed using one or more of pneumatic dissection, hydro-assisted dissection, viscoelastic-assisted dissection, and manual dissection.

[0035]

[0035] In some embodiments, the removed anterior layer of the corneal stroma has a thickness of 100 to 400 μm.

[0036]

[0036] In some embodiments, the corneal tissue scaffold device is configured to be implanted within the eye within a through recess formed in the eye by full thickness drilling.

[0037]

[0037] In some embodiments, the corneal tissue scaffold device is pretreated using at least one of the following techniques: dehydration, freeze-drying, plasticization, gelation, dehydration heat treatment, mechanical treatment, compression, decontamination, and sterilization.

[0038]

[0038] In one embodiment, a system is further provided that includes an implantable corneal tissue scaffold having a central portion defining a recess having a posterior end including a lamina of corneal tissue, the lamina comprising at least the pre-Descemet's layer and Descemet's membrane, or at least the pre-Descemet's layer, and a peripheral portion of corneal tissue surrounding the recess, the peripheral portion including one or more of the posterior layer of the corneal stroma, the pre-Descemet's layer, Descemet's membrane, and the endothelial layer; and an intracorneal implant defining a planar body having a convex surface substantially matching the convex surface of the cornea, the intracorneal implant comprising: (i) a central optic having an anterior end and an optic stem extending axially through the cornea to a posterior end; and (ii) a peripheral haptic portion having two or more angularly spaced haptics extending laterally from the central optic, wherein the intracorneal implant is mounted on the implantable corneal tissue scaffold device such that the posterior end abuts or is in contacting engagement with the lamina of corneal tissue.

[0039]

[0039] In some embodiments, the system further comprises a precorneal lamella layer sutured in place over the intracorneal implant.

[0040]

[0040] In some embodiments, the system is intended for surgical implantation within a through recess formed in the eye by a full-thickness corneal perforation.

[0041]

[0041] In one embodiment, there is further provided a device comprising a corneal implant sized and adapted for implantation within the cornea of ​​an eye, the corneal implant defining a surface having (i) an inner platform portion positioned about an axis of circular symmetry of the implant, and (ii) a peripheral portion having one or more angularly spaced arms extending laterally from a periphery of the inner platform, a wireless communication circuit configured to receive image data signals from the extraocular unit, an image projection controller configured to process the received image data signals to generate an image, and an image generator mounted to the inner platform portion and configured to project an image projection light beam posteriorly onto the retina of the eye based on the generated image.

[0042]

[0042] In one embodiment, there is further provided a method comprising providing a device comprising a corneal implant sized and adapted for implantation within the cornea of ​​an eye, the corneal implant defining a surface having (i) an inner platform portion positioned about an axis of circular symmetry of the implant, and (ii) a peripheral portion with one or more angularly spaced arms extending laterally from a periphery of the inner platform, the device comprising wireless communication circuitry configured to receive image data signals from the extraocular unit, an image projection controller configured to process the received image data signals to generate an image, and an image generator mounted on the inner platform portion and configured to project an image projection light beam rearwardly onto the retina of the eye based on the generated image, implanting the device into the cornea of ​​the eye such that there is clear corneal tissue or no corneal tissue rearward of the image generator of the device, receiving the image data signals by the wireless communication circuitry, processing the received image data signals by the image projection controller to generate an image, and projecting the image rearwardly onto the retina of the eye by the image generator.

[0043]

[0043] In some embodiments, the device further comprises a peripheral skirt defining a circular periphery of the implant, with one or more angularly spaced arms connecting between the inner platform and the peripheral skirt.

[0044]

[0044] In some embodiments, the wireless communication circuitry comprises a receiving inductive coil.

[0045]

[0045] In some embodiments, the receiving inductive coil is further configured to inductively receive power from the extraocular unit.

[0046]

[0046] In some embodiments, the wireless communication circuitry includes a photocell configured to receive a light beam that encodes an image data signal.

[0047]

[0047] In some embodiments, the photovoltaic cell is further configured to receive power from the light beam.

[0048]

[0048] In some embodiments, the device further comprises memory storage for storing the received image data signals.

[0049]

[0049] In some embodiments, the image generator comprises a liquid crystal display device having an optically coupled illuminator element.

[0050]

[0050] In some embodiments, the image generator comprises a liquid crystal display device configured to be illuminated by an extraocular illumination source.

[0051]

[0051] In some embodiments, the peripheral skirt portion, the inner platform portion, and the at least one arm define at least one opening in the planar body, the at least one opening being configured to facilitate fixation and adaptation of the device to corneal tissue via the at least one opening when the device is implanted within the cornea.

[0052]

[0052] In some embodiments, the device further comprises an optical assembly mounted behind the image generator, optically coupled to the image generator, and configured to focus the projected image onto the retina.

[0053]

[0053] In some embodiments, the device further comprises at least one haptic extending outward from the circular circumference of the implant, the at least one haptic comprising a proximal end connected to the circular circumference and a protruding segment terminating at a distal end.

[0054]

[0054] In one embodiment, there is further provided a system comprising: a corneal implant sized and adapted for implantation within the cornea of ​​an eye, the corneal implant defining a surface having (i) an inner platform portion positioned about an axis of circular symmetry of the implant, and (ii) a peripheral portion having one or more angularly spaced arms extending laterally from a periphery of the inner platform; a device comprising a wireless communication circuit configured to receive image data signals from the extraocular unit, an image projection controller configured to process the received image data signals to generate an image, and an image generator mounted on the inner platform portion and configured to project an image projection light beam backwardly onto the retina of the eye based on the generated image; and an extraocular unit comprising at least one imaging device for capturing visual images, an image processing module for processing and storing the captured visual images as digital image data, and a wireless communication module for transmitting the digital image data to the device via the wireless communication circuit.

[0055]

[0055] In one embodiment, a corneal implant sized and adapted for implantation within the cornea of ​​an eye, the corneal implant defining a surface having (i) an inner platform portion positioned about an axis of circular symmetry of the implant, and (ii) a peripheral portion having one or more angularly spaced arms extending laterally from a periphery of the inner platform; a device comprising: wireless communication circuitry configured to receive image data signals from an extraocular unit; an image projection controller configured to process the received image data signals to generate an image; an image generator mounted on the inner platform portion and configured to project an image projection light beam backwards onto the retina of the eye based on the generated image; and at least one imaging device for capturing visual images; and an imaging device for processing and storing the captured visual images as digital image data. A method is further provided that includes providing a system comprising an image processing module and an extraocular unit comprising a wireless communication module for transmitting digital image data to the device via a wireless communication circuit; implanting the device in the cornea of ​​the eye with either clear corneal tissue or no corneal tissue behind an image generator of the device; capturing at least one visual image by at least one imaging device of the extraocular unit; processing the at least one captured visual image by the image processing module to generate digital image data, transmitting image data signals by the wireless communication module and receiving the image data signals by the wireless communication circuit; processing the received image data signals by an image projection controller to generate an image; and projecting the image backwards onto the retina of the eye by the image generator.

[0056]

[0056] In some embodiments, the device further comprises a peripheral skirt defining a circular periphery of the implant, with one or more angularly spaced arms connecting between the inner platform and the peripheral skirt.

[0057]

[0057] In some embodiments, the wireless communication circuitry includes a receiving inductive coil and the wireless communication module includes a transmitting inductive coil.

[0058]

[0058] In some embodiments, the receiving inductive coil is further configured to inductively receive power from the transmitting inductive coil.

[0059]

[0059] In some embodiments, the wireless communication module comprises an optical beam source.

[0060]

[0060] In some embodiments, the wireless communication circuitry includes a photocell configured to receive a light beam encoding an image data signal, the light beam emanating from a light beam source.

[0061]

[0061] In some embodiments, the photovoltaic cell is further configured to receive power from the light beam.

[0062]

[0062] In some embodiments, the device comprises memory storage for storing the received image data signals.

[0063]

[0063] In some embodiments, the image generator comprises a liquid crystal display device having an optically coupled illuminator element.

[0064]

[0064] In some embodiments, the image generator comprises a liquid crystal display device and the extraocular unit comprises an illumination source configured to provide illumination to the liquid crystal display device.

[0065]

[0065] In some embodiments, the illumination source is configured, when implanted within the cornea, to emit sufficient illumination to cross any obstructing or opaque layers and reach the device.

[0066]

[0066] In some embodiments, the peripheral skirt portion, the inner platform portion, and the at least one arm define at least one opening in the planar body, the at least one opening being configured to facilitate fixation and adaptation of the device to corneal tissue via the at least one opening when the device is implanted within the cornea.

[0067]

[0067] In some embodiments, the device comprises an optical assembly mounted behind the image generator, optically coupled to the image generator, and configured to focus the projected image onto the retina.

[0068]

[0068] In some embodiments, the device includes at least one haptic extending outward from a circular circumference of the implant, the at least one haptic including a proximal end connected to the circular circumference and a protruding segment terminating at a distal end.

[0069]

[0069] In some embodiments, the components of the extraocular unit are mounted to one of a pair of eyeglass frames, a hat, a helmet, and a headband.

[0070]

[0070] In addition to the exemplary aspects and embodiments described above, further aspects and embodiments will become apparent by reference to the drawings and by study of the following detailed descriptions. [Brief description of the drawings]

[0071]

[0071] Exemplary embodiments are shown in the reference figures. Dimensions of components and features shown in the figures are generally selected for convenience and clarity of display and are not necessarily shown to scale. The figures are as follows:

[0072] [Figure 1A-1C]

[0072] Schematic oblique (Figure 1A), oblique cross-sectional (Figure 1B), and side cross-sectional (Figure 1C) views of an exemplary device of the present disclosure that provides a pathway for transmitting external light through the eye onto the retina to replace an obstructing or opaque layer of the cornea that is otherwise completely or partially opaque to visible light, according to some embodiments of the present disclosure. [Fig. 1D-1E]

[0073] 1 illustrates a device of the present disclosure implanted within the eye, according to some embodiments of the present disclosure. [Figures 2A-2E]

[0074] 2A, 2B, 2C, 2D, and 2E show a top perspective view, a bottom perspective view, a side view, a top view, and a bottom view, respectively, of an exemplary intracorneal implant of a device of the present disclosure, according to some embodiments of the present disclosure. [Figure 3A-3C]

[0075] 3A , 3B , and 3C are cross-sectional ( FIG. 3A ), exploded perspective ( FIG. 3B ), and exploded side ( FIG. 3C ) views of an exemplary optical stem of a device of the present disclosure configured to be implanted within the cornea of ​​an eye and transmit light from the surrounding environment and / or extraocular sources through the eye and along an optical path onto the retina, in accordance with some embodiments of the present disclosure. [Figure 4A-4B]

[0076] 4A and 4B are perspective (FIG. 4A) and side (FIG. 4B) views of an exemplary internal optical lens of the present disclosure that may be used in conjunction with a device of the present disclosure, according to some embodiments of the present disclosure. [Figure 5A-5D]

[0077] 5A, 5B, 5C, and 5D are front and rear perspective views, respectively, of an exemplary optical stem of the present disclosure that may be used in conjunction with a device of the present disclosure, according to some embodiments of the present disclosure. [Figure 6]

[0078] FIG. 2 is an exploded perspective view of an exemplary device of the present disclosure, further including an optional external optical element, according to some embodiments of the present disclosure. [Figure 7A-7D]

[0079] 7A, 7B, 7C, and 7E are front perspective views, rear perspective views, side views, and top views, respectively, of exemplary optional external optical elements (e.g., an external front end plate and / or an external optical lens) that may be further included in the devices of the present disclosure, according to some embodiments of the present disclosure. [Figure 8A-8B]

[0080] 1 illustrates an external optical lens of the present disclosure, according to some embodiments of the present disclosure. [Figure 9A-9D]

[0081] 9A, 9B, and 9C are exploded perspective (FIG. 9A), exploded side (FIG. 9B), and cross-sectional (FIG. 9D) views of an exemplary embodiment of a device of the present disclosure, according to some embodiments of the present disclosure. [Figure 10A-10C]

[0082] 10A, 10B, and 10C are exploded perspective (FIG. 10A), exploded side (FIG. 10B), and cross-sectional (FIG. 10C) views of another exemplary embodiment of a device of the present disclosure, according to some embodiments of the present disclosure. [Figures 11A-11D]

[0083] 11A, 11B, and 11C are exploded perspective (FIG. 11A), exploded side (FIG. 11B), and cross-sectional (FIGS. 11C and 11D) views of another exemplary embodiment of a device of the present disclosure, according to some embodiments of the present disclosure. [Fig. 11E-11G]

[0084] 13A-13C show exemplary variations of an optical stem with a magnetic coupling system configured to magnetically removably attach an optional external end plate to the front end of a device of the present disclosure, according to some embodiments of the present disclosure. [Figures 12A-12C]

[0085] 12A, 12B, and 12C are exploded perspective (FIG. 12A), exploded side (FIG. 12B), and cross-sectional (FIG. 12C) views of another exemplary embodiment of a device of the present disclosure, according to some embodiments of the present disclosure. [Fig. 13A-13F]

[0086] 1 illustrates functional steps in a process for the creation of an exemplary pre-treated corneal tissue scaffold derived from a donor cornea, according to some embodiments of the present disclosure. [Figure 14A-14D]

[0087] 1 illustrates an exemplary process for manufacturing a pre-assembled intracorneal system with the corneal tissue scaffolds and devices of the present disclosure, according to some embodiments of the present disclosure. [Fig. 15A-15F]

[0088] 1 illustrates functional steps in an exemplary process for surgical implantation of an assembled intracorneal system with corneal tissue scaffolds and devices of the present disclosure, according to some embodiments of the present disclosure. [Figures 16A-16G]

[0089] 1 illustrates separately functional steps in an exemplary process for surgical implantation of a pretreated corneal tissue scaffold followed by implantation of an intracorneal implant of the present disclosure, according to some embodiments of the present disclosure. [Figures 17A-17J]

[0090] 1 illustrates functional steps in an exemplary process for surgical implantation of an intracorneal implant of the present disclosure, according to some embodiments of the present disclosure. [Figures 18A-18C]

[0091] 1 is a schematic diagram of an exemplary system for intracorneal projection of an image onto a retina, in accordance with some embodiments of the present disclosure. [Figure 18D]

[0092] 1 illustrates an exemplary extraocular unit according to some embodiments of the present disclosure. [Figure 18E]

[0093] 1 illustrates an exemplary illumination source according to some embodiments of the present disclosure. [Figures 19A-19D]

[0094] 1A-1D show front perspective, rear, anterior, and side views of an exemplary intracorneal implant according to some embodiments of the present disclosure. [Figure 20]

[0095] 1 is a schematic diagram of an exemplary intracorneal implant with multiple haptics, according to some embodiments of the present disclosure. [Figures 21A-21D]

[0096] 1 illustrates steps in a process for surgical implantation of an intracorneal implant of the present disclosure into the cornea, according to some embodiments of the present disclosure. [Figure 21E]

[0097] 1 illustrates an optional optical assembly according to some embodiments of the present disclosure. [Figure 22]

[0098] 1 is a cross-sectional view of an eye having an intracorneal implant embedded within the cornea in accordance with some embodiments of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0073]

[0099] Disclosed herein are systems, devices and methods that provide an intracorneal implant configured for implantation within an eye and having a light projection posterior port configured to project an image onto the retina of the eye.

[0074]

[0100] As used herein, the term "intracorneal implant" may be used to refer to any device configured to be implanted or deployed inside the cornea of ​​the eye.

[0075]

[0101] In some embodiments, the intracorneal implants of the present disclosure are configured to be implanted within an eye such that only substantially transparent corneal tissue is posterior to the light projecting posterior port of the device, and the light projecting posterior port of the device is configured to project an image projection light beam that traverses the substantially transparent corneal tissue posterior to the light projecting posterior port to reach the retina of the eye.

[0076]

[0102] In other embodiments, the intracorneal implants of the present disclosure are configured to be implanted within the eye such that a layer of partially transparent, partially translucent, and / or partially opaque corneal tissue is posterior to the light projecting rear port of the device, and the light projecting rear port of the device is configured to project an image projection light beam that traverses the corneal tissue posterior to the light projecting rear port to reach the retina of the eye.

[0077]

[0103] In accordance with some aspects of the invention, the disclosed devices provide an optical pathway for transmitting external light through the eye and onto the retina, the pathway traversing or completely replacing a disturbing or opaque layer of the cornea that is otherwise completely or partially opaque to visible light.

[0078]

[0104] In one aspect of the present disclosure, a device is provided that includes an intracorneal implant configured for surgical implantation in the eye. In some embodiments, the device of the present disclosure may be sized and configured to traverse or completely replace the opaque tissue layer of the cornea and be surgically implanted in the eye, with only substantially transparent corneal tissue present posterior to the device. In some embodiments, the device of the present disclosure may be configured to be surgically implanted in the eye such that the light projecting posterior port of the device abuts or substantially contacts and engages a very thin layer of substantially light transmissive (e.g., having a thickness of about 10-50 μm) corneal tissue located posterior to the light projecting posterior port of the device. In some embodiments, the very thin layer includes at least the pre-Descemet's layer. In some embodiments, the very thin layer includes the pre-Descemet's layer in addition to the Descemet's membrane. In some embodiments, the very thin layer includes the pre-Descemet's layer, the Descemet's membrane, and the endothelium. In some embodiments, a very thin layer of corneal tissue acts as a barrier to prevent the device from extending into the anterior chamber, thereby avoiding potential complications including device dislocation, intraocular pressure loss, glaucoma, retroprosthetic membrane formation, or intraocular infection.

[0079]

[0105] In some embodiments, the disclosed device comprises an intracorneal implant configured to be surgically implanted within the cornea of ​​the eye, the intracorneal implant comprising an optical stem configured to transmit light from the surrounding environment and / or extraocular light source through the eye, along an optical path through the image projection posterior port, and onto the retina. In some embodiments, the disclosed intracorneal implant may be configured to be surgically implanted within the cornea of ​​the eye such that the light projection posterior port of the device abuts or substantially contacts and engages a very thin layer of substantially light-transmitting (e.g., having a thickness of about 10-50 μm) corneal tissue located posterior to the light projection posterior port of the device. In some embodiments, the very thin layer comprises at least the pre-Descemet's layer. In some embodiments, the very thin layer comprises the pre-Descemet's layer in addition to the Descemet's membrane. In some embodiments, the very thin layer comprises the pre-Descemet's layer, the Descemet's membrane, and the endothelium.

[0080]

[0106] In some embodiments, a device of the present disclosure comprises an intracorneal implant configured to be surgically implanted within the cornea of ​​an eye, the intracorneal implant comprising an optical stem configured to transmit light from the surrounding environment and / or external light source through the eye along an optical path, through the image projection port, and onto the retina, In some embodiments, the optical stem defines an optically transmissive pathway for transmitting light from the surrounding environment and / or extraocular light source through the eye along an optical path, the pathway defined by the optical stem may comprise at least one optical element, such as an optical lens.

[0081]

[0107] In some embodiments, the optical stem of the present disclosure comprises an optical device that projects an image beyond its light-projecting rear port (e.g., when the device of the present disclosure is implanted in the eye, the image is projected onto the retina) based on light being incident on the front end of the optical stem. In some embodiments, the optical stem has a light-receiving front port at the front end of the optical stem located near the front surface of the eye. The optical stem extends through the cornea to the light-projecting rear port of the optical stem close to the rear surface of the cornea. In some embodiments, the front end of the optical stem is directly below the front surface of the eye, substantially at the level of the front surface of the eye, flush with the front surface of the eye, or slightly protrudes from the front surface of the eye. In some embodiments, the front end of the optical stem is located close to the surface of the eye and is completely or partially covered by a thin conjunctival flap layer. In some embodiments, at least a portion of the front end of the optical stem is exposed from the front surface of the eye and forms a means for receiving an external optical element of the device of the present disclosure, as further described below. In some embodiments, the front end of the optical stem may comprise a front surface that functions as an external optical lens or other optical element. In some embodiments, the front end of the optical stem may be configured to receive one or more external optical elements. In some embodiments, the front end of the optical stem may include a mechanism configured to removably and / or adjustably mount one or more optional external elements. In some embodiments, the external elements may be colored or feature a design configured to be cosmetic and / or to impart a natural appearance to the eye (e.g., the external optical elements may be colored to resemble / mimic the natural color of the iris).

[0082]

[0108] In some embodiments, the optical stem is a transparent light path that allows external light or imaging components to pass through the optical stem and penetrate the light projection rear port to form an image on the retina, hi some embodiments, the optical stem includes internal optical and / or imaging components, such as lenses, along the light path that help provide a focused image on the retina.

[0083]

[0109] In other embodiments, the optical stem comprises an image generator incorporating any suitable image display and / or projection technology, such as a liquid crystal display (LCD) element with an optically coupled illuminator element, an LED projector, a laser diode projector, an LED array, etc. In some embodiments, the image generator is configured to receive image data signals from an extraocular source (such as an extraocular imaging device) and generate an optical image signal that is projected posteriorly through the light projection rear port onto the retina of the eye.

[0084]

[0110] In some embodiments, the device of the present disclosure comprises (i) an intracorneal implant configured to be surgically implanted within the cornea of ​​an eye; and (ii) an optical stem configured to transmit light from the surrounding environment and / or an extraocular light source through the eye, along an optical path, through a light projection posterior port, and onto the retina.

[0085]

[0111] In some embodiments, the intracorneal implant of the present disclosure generally defines a convex body having a convex surface that substantially matches the convex surface of the cornea. In some embodiments, the implant comprises a central optic configured to receive and retain the optical stem of the device, and a peripheral haptic. In some embodiments, the central optic comprises a circumferentially continuous annular rim that defines a central opening configured to receive and retain the optical stem of the device. In some embodiments, the peripheral haptic of the implant comprises two or more angularly spaced haptics extending laterally from the periphery of the annular body member.

[0086]

[0112] In another aspect of the present disclosure, a method is disclosed for providing a pathway for external light to be transmitted through the eye onto the retina, crossing or completely replacing an otherwise fully or partially opaque layer of the cornea that is otherwise completely or partially opaque to visible light. In some embodiments, the method includes providing a device with an intracorneal implant, and surgically implanting the intracorneal implant into the cornea of ​​the eye at a location where only substantially transparent corneal tissue is present posterior to the light-projecting posterior port of the device. In some embodiments, the intracorneal implant of the present disclosure may be configured to be surgically implanted into the cornea of ​​the eye such that the light-projecting posterior port of the device abuts or substantially contacts and engages a very thin layer of substantially light-transmitting corneal tissue (e.g., having a thickness of about 10-50 μm) located posterior to the light-projecting posterior port of the device. In some embodiments, the very thin layer includes at least the pre-Descemet's layer. In some embodiments, the very thin layer includes the pre-Descemet's layer in addition to the Descemet's membrane. In some embodiments, the very thin layer includes the pre-Descemet's layer, the Descemet's membrane, and the endothelium.

[0087]

[0113] In some embodiments, the disclosed device comprises an intracorneal implant configured to be surgically implanted within the cornea of ​​the eye, the intracorneal implant comprising an optical stem configured to transmit light from the surrounding environment and / or extraocular light source through the eye along an optical path onto the retina. In some embodiments, the disclosed intracorneal implant may be configured to be surgically implanted within the cornea of ​​the eye such that the light projecting posterior port of the device abuts or substantially contacts and engages a very thin layer of substantially optically transparent (e.g., having a thickness of about 10-50 μm) corneal tissue located posterior to the light projecting posterior port of the device. In some embodiments, the very thin layer comprises at least the pre-Descemet's layer. In some embodiments, the very thin layer comprises the pre-Descemet's layer in addition to the Descemet's membrane. In some embodiments, the very thin layer comprises the pre-Descemet's layer, the Descemet's membrane, and the endothelium. In some embodiments, the very thin layer of corneal tissue may comprise a portion of the optical path.

[0088]

[0114] In some embodiments, the optical stem defines an optically transparent pathway for transmitting light from the surrounding environment and / or extraocular sources along an optical path through the eye, and the pathway defined by the optical stem may include one or more optional optical elements, such as optical lenses. In some embodiments, the optical stem of the present disclosure includes an optical device that projects an image beyond its light projecting rear port based on light entering a light receiving front port located at the front end of the optical stem (e.g., when the device of the present disclosure is implanted in the eye, the image is projected onto the retina). In some embodiments, the optical stem has a light receiving front port located at the front end of the optical stem near the front surface of the eye. In some embodiments, the optical stem extends through the cornea to a light projecting rear port of the optical stem that is located closer to the rear surface of the cornea. In some embodiments, the front end of the optical stem is directly below the front surface of the eye, substantially at the level of the front surface of the eye, flush with the front surface of the eye, or slightly protrudes from the front surface of the eye. In some embodiments, the front end of the optical stem is adjacent to the surface of the eye and is located completely or partially under the thin conjunctival flap layer. In some embodiments, the front end of the optical stem may comprise a curved anterior surface that functions as a front end focusing optical element. In some embodiments, the front end of the optical stem may be configured to receive one or more external optical elements. In some embodiments, the optical stem comprises internal optical and / or imaging components, such as lenses, that help provide a focused image to the retina. In other embodiments, the optical stem is simply a transparent passage that allows external light or imaging components to form an image on the retina. In some embodiments, the external optical elements may be removable, replaceable, adjustable, and / or may be colored or feature a design configured to be cosmetic and / or to provide a natural appearance to the eye (e.g., the external optical elements may be colored to resemble / mimic the natural color of the iris).

[0089]

[0115] In other embodiments, the optical stem comprises an image generator incorporating any suitable image display and / or projection technology, such as a liquid crystal display (LCD) element with an optically coupled illuminator element, an LED projector, a laser diode projector, an LED array, etc. In some embodiments, the image generator is configured to receive image data signals from an extraocular source (such as an extraocular imaging device) and generate an optical image signal that is projected posteriorly through the light projection rear port onto the retina of the eye.

[0090]

[0116] In some embodiments, the intracorneal implant of the present disclosure generally defines a convex body having a convex surface that substantially matches the convex surface of the cornea. In some embodiments, the implant comprises a central optic configured to receive and retain the optical stem of the device, and a peripheral haptic portion. In some embodiments, the central optic comprises a circumferentially continuous annular body member configured to receive and retain the optical stem of the device. In some embodiments, the peripheral haptic portion of the implant comprises two or more angularly spaced haptics extending laterally from the periphery of the annular body member.

[0091]

[0117] In some embodiments, the method includes surgically implanting the device of the present disclosure in the recipient by first making a deep lamellar incision (e.g., pneumatic, hydro-assisted, viscoelastic-assisted, and / or manual incision) in the recipient cornea that separates between the deep posterior stroma and the pre-Descemet layer (alternatively, between the pre-Descemet layer and the Descemet membrane). A partial thickness drilling and anterior keratectomy is performed to remove the anterior lamella of the recipient cornea. The deep posterior stroma (e.g., the bubble roof) is removed to create a recess, leaving the subsequent layers, i.e., the pre-Descemet layer, the Descemet membrane, and / or the endothelium, intact. The device of the present disclosure is placed and sutured into the created recess. The previously removed recipient anterior lamella or the donor anterior lamella is sutured. A conjunctival flap may be placed to temporarily cover the cornea. The conjunctival flap may then be partially removed to create a central opening corresponding to the anterior end of the device, which may be configured to receive one or more external optics. As used herein, a "recess" may refer to any opening, incision, separation, gap, or other opening of any shape in the cornea that may accommodate an intracorneal implant.

[0092]

[0118] In yet another aspect of the present disclosure, a pre-treated corneal tissue scaffold is provided that is derived from a donor cornea and includes at least a portion of a stromal layer, a pre-Descemet's layer, a Descemet's membrane, and / or an endothelium.

[0093]

[0119] In some embodiments, a corneal tissue scaffold of the present disclosure may include corneal layers of varying composition in different regions thereof. For example, a corneal tissue scaffold may include a pre-Descemet's layer, a Descemet's membrane, and / or an endothelium in a central, substantially transparent region thereof. Thus, in some embodiments, the central region of the corneal tissue scaffold is configured to be substantially optically transparent. In some embodiments, regions of the corneal tissue scaffold surrounding the central, substantially transparent region may have corneal layers of different composition, including at least a portion of a stromal layer, a pre-Descemet's layer, a Descemet's membrane, and / or an endothelium.

[0094]

[0120] In some embodiments, the pre-processed corneal tissue scaffold of the present system comprises corneal tissue derived from a donor human cornea. In some embodiments, the corneal tissue is first harvested from a donor. The harvested corneal tissue may then be preserved using conventional tissue preservation methods and transported to an appropriate processing location or facility for evaluation, preparation, processing and storage.

[0095]

[0121] In some embodiments, the corneal tissue is then prepared by performing a deep lamellar incision (e.g., pneumatic, hydro-assisted, viscoelastic-assisted, and / or manual incision) separating (i) the posterior stroma and the pre-Descemet layer, or alternatively (ii) the pre-Descemet layer and the Descemet membrane. A partial thickness drilling and anterior keratectomy is performed to remove the donor anterior corneal lamella. The deep posterior stroma (e.g., the bubble roof) is removed to create a recess, leaving the subsequent layers, i.e., the pre-Descemet layer, the Descemet membrane, and / or the endothelium, intact. A full thickness drilling is then performed to obtain a corneal tissue scaffold.

[0096]

[0122] The resulting corneal tissue scaffold may then be decontaminated, dehydrated, sterilized, and packaged for use by surgeons and other medical professionals in appropriate surgical procedures, as further described herein.

[0097]

[0123] In some embodiments, the corneal tissue scaffold of the present system may be further pretreated using any one or more suitable pretreatment methods and techniques to stabilize and protect the corneal tissue scaffold during preparation, storage, and transportation. In some embodiments, pretreatment methods and techniques according to the present invention may include, but are not limited to, dehydration, lyophilization, plasticization, gelation, dehydration heat treatment, mechanical treatment, compression, decontamination, sterilization, and the like.

[0098]

[0124] In some embodiments, the pre-treatment prevents the corneal tissue scaffold from decomposing, spoiling, infecting, and / or breaking during storage and transportation, and allows the corneal tissue scaffold to be stored at room temperature or below room temperature. In some embodiments, the pre-treatment also helps maintain the corneal tissue scaffold to have similar material properties as living or hydrated or processed tissue. In some embodiments, the pre-treatment allows the corneal tissue scaffold to be directly implanted into a recipient subject after removal from the package with no or minimal further processing.

[0099]

[0125] In some embodiments, the pre-treated donor corneal tissue scaffold of the present disclosure is configured to be implanted into a recipient subject to replace at least a portion of the subject's stromal layer, pre-Descemet's layer, Descemet's membrane, and / or endothelial layer in preparation for further implantation of a device of the present disclosure as further detailed herein. In such embodiments, the pre-treated corneal tissue scaffold of the present disclosure is configured to be implanted simultaneously with a full thickness transplant procedure in which a full thickness resection of the patient's cornea is performed, followed by replacement with an implant and / or system comprised of at least the corneal tissue scaffold of the present disclosure.

[0100]

[0126] In yet another aspect of the present disclosure, a system is provided that includes: (i) a device configured to be surgically implanted in an eye; and (ii) a pre-treated corneal tissue scaffold derived from a donor cornea and including at least a portion of a stromal layer, a pre-Descemet's layer, a Descemet's membrane, and / or an endothelial layer.

[0101]

[0127] In some embodiments, the device of the system comprises an intracorneal implant comprising an optical stem. In some embodiments, the optical stem is configured to transmit light from the environment and / or extraocular light source along an optical path through the eye, through the light projection rear port, and onto the retina. In some embodiments, the optical stem defines an optically transparent pathway for transmitting light from the environment and / or extraocular light source along an optical path through the eye, and the pathway defined by the optical stem may comprise one or more optional external optical elements, such as optical lenses.

[0102]

[0128] In some embodiments, the optical stem comprises an optical device that forms an image beyond its light projecting rear port (e.g., when the device of the system is implanted in the eye, the image is projected onto the retina) based on light entering a light receiving front port located at the front end of the optical stem. In some embodiments, the optical stem has a light receiving front port close to the front surface and extends axially through the cornea to the light projecting rear port of the optical stem closer to the rear surface of the cornea. In some embodiments, the front end of the optical stem is directly below the front surface of the eye, substantially at the level of the front surface of the eye, flush with the front surface of the eye, or slightly protrudes from the front surface of the eye. In some embodiments, the front end of the optical stem is located close to the surface of the eye and completely or partially below a thin conjunctival flap layer. In some embodiments, the front end of the optical stem may comprise a curved front surface that functions as a front end focusing optic and / or one or more separately formed external optics. In some embodiments, the front end of the optical stem may be configured to receive one or more external optics. In some embodiments, the front end of the optical stem may include a mechanism configured to removably and / or adjustably mount one or more external optical elements, in some embodiments, the external elements may be colored or feature a design configured to provide a cosmetic or natural appearance to the eye (e.g., the external optical elements may be colored to resemble / mimic the natural color of the iris).

[0103]

[0129] In some embodiments, the optical stem comprises internal optical and / or imaging components, such as lenses, that help provide a focused image on the retina, while in other embodiments, the optical stem is simply a transparent passageway that allows external light or imaging components to form an image on the retina.

[0104]

[0130] In other embodiments, the optical stem comprises an image generator incorporating any suitable image display and / or projection technology, such as a liquid crystal display (LCD) element with an optically coupled illuminator element, an LED projector, a laser diode projector, an LED array, etc. In some embodiments, the image generator is configured to receive image data signals from an extraocular source (such as an extraocular imaging device) and generate an optical image signal that is projected posteriorly through the light projection rear port onto the retina of the eye.

[0105]

[0131] In some embodiments, the intracorneal implant of the system generally defines a convex body having a convex surface that substantially follows the convex surface of the cornea. In some embodiments, the implant comprises a central optic and peripheral haptics. In some embodiments, the central optic comprises a circumferentially continuous annular body member configured to receive and retain the optical stem of the device. In some embodiments, the peripheral haptics of the implant comprise two or more angularly spaced haptics extending laterally from a periphery of the annular body member.

[0106]

[0132] In some embodiments, the corneal tissue scaffold of the present systems may include corneal layers of different compositions in different regions thereof. For example, the corneal tissue scaffold may include a pre-Descemet's layer, a Descemet's membrane, and / or an endothelium in a central, substantially transparent region thereof. Thus, in some embodiments, the central region of the corneal tissue scaffold is configured to be substantially optically transparent. In some embodiments, regions of the corneal tissue scaffold surrounding the central, substantially transparent region may have corneal layers of different compositions, including at least a portion of a stromal layer, a pre-Descemet's layer, a Descemet's membrane, and / or an endothelium.

[0107]

[0133] In some embodiments, the pre-processed corneal tissue scaffold of the present system comprises corneal tissue derived from a donor human cornea. In some embodiments, the corneal tissue is first harvested from a donor. The harvested corneal tissue may then be preserved using conventional tissue preservation methods and transported to an appropriate processing location or facility for evaluation, preparation, processing and storage.

[0108]

[0134] In some embodiments, the donor corneal tissue is then prepared by performing a deep lamellar dissection (e.g., pneumatic, hydro-assisted, viscoelastic-assisted, and / or manual dissection) separating (i) the posterior stroma and the pre-Descemet layer, or alternatively (ii) the pre-Descemet layer and the Descemet membrane. A partial thickness drilling and anterior keratectomy is performed to remove the donor anterior corneal lamella. The deep posterior stroma (e.g., the bubble roof) is removed to create a recess, leaving the subsequent layers, i.e., the pre-Descemet layer, the Descemet membrane, and / or the endothelium, intact. A full thickness drilling is then performed to obtain a corneal tissue scaffold.

[0109]

[0135] The resulting corneal tissue scaffold may then be decontaminated, dehydrated, sterilized, and packaged for use by surgeons and other medical professionals in appropriate surgical procedures, as further described herein.

[0110]

[0136] In some embodiments, the corneal tissue scaffold of the present system may be further pretreated using any one or more suitable pretreatment methods and techniques to stabilize and protect the corneal tissue scaffold during preparation, storage, and transportation. In some embodiments, the pretreatment methods and techniques according to the present invention may include, but are not limited to, dehydration, freeze-drying, plasticization, gelation, dehydration heat treatment, mechanical treatment, compression, decontamination, sterilization, and the like. In some embodiments, the pretreatment prevents the corneal tissue scaffold from decomposing, spoiling, infecting, and / or breaking during storage and transportation, and allows the corneal tissue scaffold to be stored at room temperature or below room temperature. In some embodiments, the pretreatment also helps to maintain the corneal tissue scaffold to have similar material properties as living or hydrated tissue or processed tissue. In some embodiments, the pretreatment allows the corneal tissue scaffold to be directly implanted into a recipient subject without or with minimal further processing after removal from the package.

[0111]

[0137] In some embodiments of the system, the corneal tissue scaffold and device are pre-assembled such that the light-projecting posterior port of the device abuts or is in substantial contacting engagement with a very thin layer of corneal tissue that is substantially transparent to light (e.g., having a thickness of about 10-50 μm) posterior to the light-projecting posterior port of the device. In some embodiments, the very thin layer includes at least the pre-Descemet's layer. In some embodiments, the very thin layer includes the pre-Descemet's layer in addition to the Descemet's membrane. In some embodiments, the very thin layer includes the pre-Descemet's layer, the Descemet's membrane, and the endothelium.

[0112]

[0138] In some embodiments, the system is configured to be surgically implanted into a recipient in a pre-assembled configuration with the device pre-attached to a corneal tissue scaffold, simultaneously with a full thickness resection of the patient's cornea, followed by a full thickness transplant procedure in which the system is placed (e.g., sutured) in place.

[0113]

[0139] In some embodiments, the device and the corneal tissue scaffold form separate parts of the system, and the corneal tissue scaffold is configured to be surgically implanted into a recipient subject to replace at least a portion of the subject's stromal layer, pre-Descemet's layer, Descemet's membrane, and / or endothelial layer in preparation for further implantation of an intracorneal implant of the system as further detailed herein. In such embodiments, the pretreated corneal tissue scaffold of the system is configured to be implanted simultaneously with a full thickness transplant procedure in which a full thickness resection of the patient's cornea is performed.

[0114]

[0140] In some embodiments, after implantation of the corneal tissue scaffold, the device is implanted within the recipient's cornea such that the light-projecting posterior port of the device abuts or substantially contacts and engages a very thin layer of corneal tissue that is substantially transparent to light (e.g., having a thickness of about 10-50 μm) posterior to the light-projecting posterior port of the device. In some embodiments, the very thin layer includes at least the pre-Descemet's layer. In some embodiments, the very thin layer includes the pre-Descemet's layer in addition to the Descemet's membrane. In some embodiments, the very thin layer includes the pre-Descemet's layer, the Descemet's membrane, and the endothelium.

[0115]

[0141] In some embodiments, a very thin layer of corneal tissue acts as a barrier to prevent the intracorneal implants of the present disclosure from extending into the anterior chamber, thereby avoiding potential complications including device dislocation, intraocular pressure loss, glaucoma, retroprosthetic membrane formation, or intraocular infection.

[0116]

[0142] In accordance with some aspects of the present invention, a device of the present disclosure provides an intracorneal implant configured to be surgically implanted within the cornea of ​​an eye, the intracorneal implant comprising an image generator attached to the intracorneal implant, the image generator configured and operable to receive image data signals from an extraocular source and generate an image projection light beam (e.g., a light beam modulated with visual image information) that is projected onto the retina of the eye to generate an image.

[0117]

[0143] In some embodiments, the devices of the present disclosure may be sized and configured to traverse or completely replace the opaque tissue layer of the cornea and be surgically implanted within the eye, with only substantially transparent corneal tissue present behind the device.

[0118]

[0144] In some embodiments, the devices of the present disclosure may be sized and configured to be surgically implanted within the eye so as to reside posterior to the light-illuminating rear port of the device.

[0119]

[0145] In some embodiments, the device of the present disclosure may be configured to be surgically implanted in the eye such that the light-projecting posterior port of the device abuts or substantially contacts and engages a very thin layer of substantially light-transmitting (e.g., having a thickness of about 10-50 μm) corneal tissue located posterior to the light-projecting posterior port of the device. In some embodiments, the very thin layer includes at least the pre-Descemet's layer. In some embodiments, the very thin layer includes the pre-Descemet's layer in addition to the Descemet's membrane. In some embodiments, the very thin layer includes the pre-Descemet's layer, the Descemet's membrane, and the endothelium. In some embodiments, the very thin layer of corneal tissue acts as a barrier to prevent the device from extending into the anterior chamber, thereby avoiding potential complications including dislocation of the device, intraocular hypotension, glaucoma, retroprosthetic membrane formation, or intraocular infection.

[0120]

[0146] In some embodiments, the devices of the present disclosure include an intracorneal implant sized to fit within the cornea, hi some embodiments, the intracorneal implant has a convex surface that substantially matches the convex surface of the cornea and defines a surface having opposing convex anterior surface (facing the anterior surface of the eye) and concave posterior surface (facing the retina of the eye).

[0121]

[0147] In some embodiments, the intracorneal implant comprises an inner platform portion located about an axis of circular symmetry of the implant and a peripheral portion comprising one or more angularly spaced arms extending laterally from a periphery of the inner platform, hi some embodiments, the intracorneal implant further comprises a peripheral skirt portion defining a circular periphery of the intracorneal implant, the one or more angularly spaced arms connecting between the inner platform and the peripheral skirt portion.

[0122]

[0148] In some embodiments, the intracorneal implant of the device of the present disclosure may further comprise two or more angularly spaced haptics extending laterally from the periphery of the implant, which may function structurally to position and center the intracorneal implant at a desired location within a pocket formed in the cornea during surgery, e.g., to align with the optical axis of the eye.

[0123]

[0149] In some embodiments, one or more openings formed in the intracorneal implant of the present disclosure, for example located around one or more connecting arms or a peripheral skirt, may be configured to allow for adaptation of the device within the cornea to secure the intracorneal implant in a desired position over time.

[0124]

[0150] In some embodiments, the intracorneal implant of the present disclosure comprises one or more of an image generator, an image projection controller with a hardware processor and memory storage, an optical assembly, a wireless receiver module, and a wireless receiving element.

[0125]

[0151] In some embodiments, the device of the present disclosure comprises an image generator mounted on an intracorneal implant that is configured and operable to receive image data signals from an extraocular source and generate an image projection light beam (e.g., a light beam modulated with visual image information) that is projected through a rear projection port onto the retina of the eye to generate an image. As used herein, the term visual image information may encompass any optically conveyed information, including optical reproductions of objects or scenes, and / or information optically represented by text, symbols, colors, etc.

[0126]

[0152] In some embodiments, the image generator is configured to receive image data signals from an extraocular source and generate an image projection light beam that can pass through any semi-opaque and / or substantially opaque corneal tissue present in front of the device to reach the retina of the eye.

[0127]

[0153] In some embodiments, devices of the present disclosure may be configured to receive image data signals from an image data source external to the eye via a non-optical data transmission modality, such as radio frequency (RF) or similar data transmission, which can cross a barrier or opaque layer of the eye (e.g., the cornea, conjunctiva, or other form of tissue flap) that is otherwise completely or partially opaque to visible light.

[0128]

[0154] Thus, in some embodiments, the disclosed device is configured to receive digital image data signals from an external source via a non-optical data transmission path, e.g., short-range RF transmission, process the digital image data encoded in the image data signal, generate a light beam modulated with the image information encoded in the digital image data, and project the generated light beam onto the retina via an optical transmission path, which may include an optical assembly including, e.g., one or more focusing optics and / or an ocular lens.

[0129]

[0155] In some embodiments, devices of the present disclosure include a wireless receiver module configured to wirelessly receive image data signals representing image information via a non-optical wireless transmission modality, such as a short-range RF communication protocol.

[0130]

[0156] In some embodiments, the device of the present disclosure comprises an image projection controller that receives input image data received by the wireless receiver module, optionally stores the image data in a memory storage module, processes the digital image data encoded in the signal to generate and reconstruct a visual image therefrom, operates an image generator to generate a light beam based on the image data, and projects the generated light beam onto the retina.

[0131]

[0157] In some embodiments, a device of the present disclosure comprises an image generator for displaying and / or projecting an optical image signal representative of a type of visual image suitable for detection by the retina. In some embodiments, the image generator may incorporate any suitable image display and / or projection technology, such as a liquid crystal display (LCD) element with an optically coupled illuminator element, an LED projector, a laser diode projector, an LED array, etc. In some embodiments, the image generator comprises an optical assembly comprising any suitable focusing or other optical system.

[0132]

[0158] In some embodiments, the device of the present disclosure may further comprise a power source configured to power the device. In some embodiments, the power source is configured to receive power from an external power source using wireless power transmission. This is done to avoid the use of a wired power connection to an external power source or an internal battery, which must pass through the surface of the eye, and thus entails some practical drawbacks as well as risks such as infection. Similarly, powering the device using a replaceable battery placed or attached inside the implantable device itself is impractical due to the bulkiness of the battery, and would require surgical intervention to replace. Thus, in some embodiments, the present disclosure provides for inductively transmitting power to an intraocular device. Thus, for example, a primary (external) inductive coil may be placed near the eye, for example around the lens area of ​​glasses or within the rim, and a secondary (internal) receiving coil within the device may be used to receive the power transmitted by the primary coil. Thus, in some embodiments, the power source may be configured to be charged or receive power via wireless power transmission, for example via electromagnetic inductive power transmission or any other suitable wireless power transmission technology.

[0133]

[0159] In some embodiments, the wireless power and data transmission is performed via transmitted light, and the extraocular unit is configured to transmit the combined power and image data signals to the intracorneal implant via a light beam. In some embodiments, the present disclosure provides wireless and / or data transfer between the extraocular unit and the device via transmitted light. In some embodiments, the power and data transmission may be performed simultaneously such that an optical transmitted power signal is transmitted between the extraocular unit and the intracorneal implant, and the power signal may encode data during at least a portion of its transmission period. Thus, in some embodiments, the device of the present disclosure comprises a wireless receiver module configured to receive the power and image data signals transmitted by the extraocular unit via transmitted light signals. In some embodiments, the wireless receiver module may comprise, for example, a photovoltaic cell.

[0134]

[0160] In yet another aspect, a system is provided comprising an intracorneal implant configured to be surgically implanted within a cornea of ​​an eye; and an extraocular image capture unit in wireless power and data communication with the intracorneal implant, the extraocular image capture unit configured to wirelessly transmit power and image data to the intracorneal implant, the image data representing a visual image captured by the extraocular unit, and the intraocular implant configured to generate an image projection light beam (e.g., a light beam modulated with visual image information) from the received image data and project the generated light beam onto a retina of the eye to generate a captured visual image.

[0135]

[0161] In some embodiments, the extraocular unit of the system comprises at least an imaging device for capturing visual images, an image processing module with one or more hardware processors and memory storage for processing and storing digital image data and generating image data signals for transmission to the intracorneal implant, a wireless transmitter for transmitting the image data signals to the intracorneal implant, e.g., using any suitable short-range RF communication protocol, and a power source for powering the extraocular unit and / or the intracorneal unit, e.g., using wireless power transmission.

[0136]

[0162] In some embodiments, the extraocular unit of the system of the present disclosure may be formed by several components disposed in a conventional eyeglass frame or coupled to another head-worn element such as a helmet, headband, or the like.

[0137]

[0163] In some embodiments, the intracorneal implant of the system comprises one or more of an image projection controller with a hardware processor and memory storage, an image generator, an optical assembly, a wireless receiver module, and a wireless receiving element.

[0138]

[0164] In some embodiments, the intraocular implant of the system may be sized and configured to traverse or completely replace the opaque tissue layer of the cornea and be surgically implanted within the eye, with only substantially transparent corneal tissue remaining behind the intraocular implant.

[0139]

[0165] In some embodiments, the intraocular implant of the system may be sized and configured to be surgically implanted within the eye such that a layer of partially transparent, partially translucent, and / or partially opaque corneal tissue is posterior to the light-illuminating rear port of the device.

[0140]

[0166] In some embodiments, the intraocular implant of the system may be configured to be surgically implanted in the eye such that the light-projecting posterior port of the intraocular implant abuts or substantially contacts and engages a very thin layer of substantially light-transmitting (e.g., having a thickness of about 10-50 μm) corneal tissue located posterior to the light-projecting posterior port of the intraocular implant. In some embodiments, the very thin layer includes at least the pre-Descemet's layer. In some embodiments, the very thin layer includes the pre-Descemet's layer in addition to the Descemet's membrane. In some embodiments, the very thin layer includes the pre-Descemet's layer, the Descemet's membrane, and the endothelium. In some embodiments, the very thin layer of corneal tissue acts as a barrier to prevent the intraocular implant from extending into the anterior chamber, thereby avoiding potential complications including dislocation of the intraocular implant, intraocular hypotension, glaucoma, retroprosthetic membrane formation, or intraocular infection.

[0141]

[0167] In some embodiments, the intraocular implant of the system includes an intracorneal implant sized to fit within the cornea. In some embodiments, the intracorneal implant has a convex surface that substantially matches the convex surface of the cornea and defines a surface having opposing convex anterior surfaces (facing the anterior surface of the eye) and concave posterior surfaces (facing the retina of the eye). In some embodiments, the intracorneal implant is

[0142]

[0168] In some embodiments, the intracorneal implant comprises an inner platform portion located about an axis of circular symmetry of the implant and a peripheral portion comprising one or more angularly spaced arms extending laterally from a periphery of the inner platform, hi some embodiments, the intracorneal implant further comprises a peripheral skirt portion defining a circular periphery of the intracorneal implant, the one or more angularly spaced arms connecting between the inner platform and the peripheral skirt portion.

[0143]

[0169] In some embodiments, the intraocular implant of the system may further comprise two or more angularly spaced haptics extending laterally from the periphery of the implant, which may structurally function to position and center the intracorneal implant at a desired location within a pocket formed in the cornea during surgery, e.g., to align with the optical axis of the eye.

[0144]

[0170] In some embodiments, one or more openings formed in the intracorneal implant of the system, for example located around one or more connecting arms or a peripheral skirt, may be configured to allow for adaptation of the intraocular implant within the cornea to secure the intracorneal implant in a desired position over time.

[0145]

[0171] In some embodiments, the intraocular implant of the system comprises an image generator attached to the intracorneal implant, the image generator configured and operable to output an image projection light beam (e.g., a light beam modulated with image information) that is projected onto the retina of the eye to generate an image.

[0146]

[0172] In some embodiments, the image generator is configured to output an image projection light beam that can pass through any transparent, semi-opaque, and / or substantially opaque corneal tissue present behind the light projection rear port of the device to reach the retina of the eye.

[0147]

[0173] In some embodiments, the intraocular implant of the system may be configured to receive image data signals from the extraocular unit of the system via a non-optical data transmission modality, such as radio frequency (RF) or similar data transmission, which may cross a barrier or opaque layer of the eye (e.g., the cornea, conjunctiva, or other form of tissue flap) that is otherwise completely or partially opaque to visible light.

[0148]

[0174] Thus, in some embodiments, the intraocular implant of the system is configured to receive digital image data signals from the extraocular unit via a non-optical data transmission path, e.g., short-range RF transmission, process the digital image data encoded in the image data signals, generate a light beam modulated / patterned with the image information encoded in the digital image data, and project the generated light beam onto the retina via an optical transmission path, which may include one or more focusing optics and / or an ocular lens.

[0149]

[0175] In some embodiments, the intraocular implant of the system comprises a wireless receiver module that wirelessly communicates with a wireless transmitter of the extraocular unit of the system and is configured to wirelessly receive image data signals representing image information via a non-optical wireless transmission modality, e.g., a short-range RF communication protocol.

[0150]

[0176] In some embodiments, the intraocular implant of the system comprises an image projection controller that receives input image data received by the wireless receiver module from the extraocular unit and optionally stored by the memory storage module, processes the digital image data encoded in the signal to generate and reconstruct a visual image therefrom, and operates the image generator to modulate and project a light beam onto the retina based on the image data.

[0151]

[0177] In some embodiments, the intraocular implant of the system comprises an image generator for displaying and / or projecting an optical image signal representative of a type of visual image suitable for detection by the retina. In some embodiments, the image generator may incorporate any suitable image display and / or projection technology, such as a liquid crystal display (LCD) element with an optically coupled illuminator element, an LED projector, a laser diode projector, an LED array, etc. In some embodiments, the image generator comprises an optical assembly comprising any suitable focusing or other optical system.

[0152]

[0178] In some embodiments, the intraocular implant of the system may further comprise a power source configured to provide power to the intraocular implant. In some embodiments, the power source is configured to receive power from an external power source using wireless power transmission. This is done to avoid the use of an external power source or a wired power connection to an internal battery, which must pass through the surface of the eye and thus entails several practical disadvantages as well as risks such as infection. Similarly, powering the intraocular implant using a replaceable battery located or attached inside the implantable intraocular implant itself is impractical due to the bulkiness of the battery and would require surgical intervention to replace. Thus, in some embodiments, the system provides for inductively transmitting power to the intraocular implant in the eye. Thus, for example, a primary (external) inductive coil may be placed near the eye, for example around the lens area of ​​the eyeglasses or within the rim, and a secondary (internal) receiving coil in the intraocular implant may be used to receive the power transmitted by the primary coil. Thus, in some embodiments, the power source may be configured to be charged or receive power via wireless power transmission, for example via electromagnetic inductive power transmission or any other suitable wireless power transmission technology.

[0153]

[0179] In some embodiments, the wireless power and data transmission is performed via transmitted light, and the extraocular unit is configured to transmit the combined power and image data signals to the intracorneal implant via a light beam. In some embodiments, the system provides wireless and / or data transfer between the extraocular unit and the intracorneal implant via transmitted light. In some embodiments, the power and data transmission may be performed simultaneously such that an optically transmitted power signal is transmitted between the extraocular unit and the intracorneal implant, and the power signal may encode data during at least a portion of its transmission period.

[0154]

[0180] Thus, in some embodiments, the extraocular unit of the system comprises a transmitter configured to transmit power and / or data signals via transmitted light. In some embodiments, the transmitter is configured to transmit one or both of power and data during any predefined time interval. For example, during the data transmission portion, the signal may carry information that is encoded by variations in the amplitude of the power signal or by any other suitable modulation technique. Similarly, in some embodiments, the intracorneal implant of the system comprises a wireless receiver module configured to receive the power and image data signals transmitted by the extraocular unit via transmitted light signals. In some embodiments, the wireless receiver module may comprise, for example, a photocell.

[0155]

[0181] In yet another aspect, a system is provided that includes an intracorneal implant configured to be surgically implanted within a cornea of ​​an eye, and an extraocular image capture unit in wireless power and data communication with the intracorneal implant.

[0156]

[0182] In some embodiments, the extraocular unit of the system comprises at least an imaging device for capturing visual images, an image processing module with one or more hardware processors and memory storage for processing and storing digital image data and generating image data signals for transmission to the intracorneal implant, a wireless transmitter for transmitting the image data signals to the intracorneal implant, e.g., using any suitable short-range RF communication protocol, and a power source for powering the extraocular unit and / or the intracorneal unit, e.g., using wireless power transmission.

[0157]

[0183] In some embodiments, the extraocular unit of the system of the present disclosure may be formed by several components disposed in a conventional eyeglass frame or coupled to another head-worn element such as a helmet, headband, or the like.

[0158]

[0184] In some embodiments, the intracorneal implant of the present disclosure comprises one or more of an image projection controller with a hardware processor and memory storage, an image generator, an optical assembly, a wireless receiver module, and a wireless receiving element.

[0159]

[0185] In some embodiments, the intraocular implant may be sized and configured to traverse or completely replace the opaque tissue layer of the cornea and be surgically implanted within the eye, with only substantially transparent corneal tissue present behind the intraocular implant.

[0160]

[0186] In some embodiments, the intraocular implant may be sized and configured to be surgically implanted within the eye such that a layer of partially transparent, partially translucent, and / or partially opaque corneal tissue resides posterior to the light-illuminating rear port of the device.

[0161]

[0187] In some embodiments, the intraocular implant of the system may be configured to be surgically implanted in the eye such that the light-projecting posterior port of the intraocular implant abuts or substantially contacts and engages a very thin layer of substantially light-transmitting (e.g., having a thickness of about 10-50 μm) corneal tissue located posterior to the light-projecting posterior port of the intraocular implant. In some embodiments, the very thin layer includes at least the pre-Descemet's layer. In some embodiments, the very thin layer includes the pre-Descemet's layer in addition to the Descemet's membrane. In some embodiments, the very thin layer includes the pre-Descemet's layer, the Descemet's membrane, and the endothelium. In some embodiments, the very thin layer of corneal tissue acts as a barrier to prevent the intraocular implant from extending into the anterior chamber, thereby avoiding potential complications including dislocation of the intraocular implant, intraocular hypotension, glaucoma, retroprosthetic membrane formation, or intraocular infection.

[0162]

[0188] In some embodiments, the intraocular implant of the system includes an intracorneal implant sized to fit within the cornea. In some embodiments, the intracorneal implant has a convex surface that substantially matches the convex surface of the cornea and defines a surface having opposing convex anterior surfaces (facing the anterior surface of the eye) and concave posterior surfaces (facing the retina of the eye). In some embodiments, the intracorneal implant is

[0163]

[0189] In some embodiments, the intracorneal implant comprises an inner platform portion located about an axis of circular symmetry of the implant and a peripheral portion comprising one or more angularly spaced arms extending laterally from a periphery of the inner platform, hi some embodiments, the intracorneal implant further comprises a peripheral skirt portion defining a circular periphery of the intracorneal implant, the one or more angularly spaced arms connecting between the inner platform and the peripheral skirt portion.

[0164]

[0190] In some embodiments, the intraocular implant of the system may further comprise two or more angularly spaced haptics extending laterally from the periphery of the implant, which may structurally function to position and center the intracorneal implant at a desired location within a pocket formed in the cornea during surgery, e.g., to align with the optical axis of the eye.

[0165]

[0191] In some embodiments, one or more openings formed in the intracorneal implant of the system, for example located around one or more connecting arms or a peripheral skirt, may be configured to allow for adaptation of the intraocular implant within the cornea to secure the intracorneal implant in a desired position over time.

[0166]

[0192] In some embodiments, the intraocular implant of the system comprises an image generator attached to the intracorneal implant, the image generator configured and operable to generate an image pattern on a panel, such as a liquid crystal display (LCD) panel, which can be projected to generate an image on the retina of the eye.

[0167]

[0193] In some embodiments, an intraocular implant of the system comprises a wireless receiver module for wireless communication with a wireless transmitter of an extraocular unit of the system, the wireless receiver module configured to wirelessly receive image data signals representative of image information via a non-optical wireless transmission modality, such as a short-range RF communication protocol. In some embodiments, the wireless receiver module is configured to receive image data signals from the extraocular unit of the system via a non-optical data transmission modality, such as radio frequency (RF) or similar data transmission, that can cross a barrier or opaque layer of the eye (e.g., the cornea, conjunctiva, or other form of tissue flap) that is otherwise completely or partially opaque to visible light.

[0168]

[0194] Thus, in some embodiments, the wireless receiver module of the intraocular implant of the system is configured to receive digital image data signals from the extraocular unit via a non-optical data transmission path, such as short-range RF transmission, process the digital image data encoded in the image data signals to generate an image pattern or a series of image patterns on the display panel, and project the generated image patterns onto the retina via an optical transmission path, which may include one or more focusing optics and / or the lens of the eye.

[0169]

[0195] In some embodiments, the intraocular implant of the system comprises an image projection controller that receives input image data received by the wireless receiver module from the extraocular unit and optionally stored by the memory storage module, processes the digital image data encoded in the signal to generate and reconstruct a visual image therefrom, and operates a display panel to form an image pattern therein and project it onto the retina.

[0170]

[0196] In some embodiments, the intraocular implant of the system comprises an image generator for displaying a light image representative of a type of visual image suitable for detection by the retina. In some embodiments, the image generator may incorporate any suitable image display, such as a liquid crystal display (LCD) element having an optically coupled illuminator element. In some embodiments, the image generator comprises an optical assembly comprising any suitable focusing or other optical system.

[0171]

[0197] In some embodiments, the intraocular implant of the system may further comprise a power source configured to provide power to the intraocular implant, hi some embodiments, the power source is configured to receive power from an external power source using wireless power transmission.

[0172]

[0198] In some embodiments, the system comprises an external illumination source that may be included in the extraocular unit and configured to illuminate an image generator (e.g., an LCD panel) of the intracorneal implant to project an image displayed therein onto the retina of the eye.

[0173]

[0199] In some embodiments, the system comprises an intraocular illumination source that may be attached or coupled to the image generator of the intracorneal extraocular unit and configured to illuminate the image generator (e.g., an LCD panel) of the intracorneal implant for projecting an image displayed therein onto the retina of the eye. Thus, in some embodiments, the image generator may comprise an LCD panel configured to display a visual image. In some embodiments, the LCD panel may comprise a backlight illumination source or another similar illumination source integrated into the intracorneal implant.

[0174]

[0200] In some embodiments, the wireless power and data transmission is performed via transmitted light, and the extraocular unit is configured to transmit the combined power and image data signals to the intracorneal implant via a light beam. In some embodiments, the present disclosure provides for wireless and / or data transfer between the extraocular unit and the intracorneal implant via transmitted light. In some embodiments, the power and data transmission may be performed simultaneously such that an optically transmitted power signal is transmitted between the extraocular unit and the intracorneal implant, and the power signal may encode data during at least a portion of its transmission period.

[0175]

[0201] Thus, in some embodiments, the extraocular unit of the system comprises a transmitter configured to transmit power and / or data signals via transmitted light. In some embodiments, the transmitter is configured to transmit one or both of power and data during any predefined time interval. For example, during the data transmission portion, the signal may carry information that is encoded by variations in the amplitude of the power signal or by any other suitable modulation technique. Similarly, in some embodiments, the intracorneal implant of the system comprises a wireless receiver module configured to receive the power and image data signals transmitted by the extraocular unit via transmitted light signals. In some embodiments, the wireless receiver module may comprise, for example, a photocell.

[0176]

[0202] Reference is made to Figures 1A to 1C, which show a schematic diagram of an exemplary device 100 of the present disclosure having an intracorneal implant 200 and an optical stem 300 in a perspective view (Figure 1A), a perspective cross-sectional view (Figure 1B), and a side cross-sectional view (Figure 1C).

[0177]

[0203] Reference is also made to FIGS. 1D to 1E, which show a schematic exploded perspective view (FIG. 1D) and a side view (FIG. 1E) of a device 100 with an intracorneal implant 200 and an optical stem 300 implanted in an eye 101.

[0178]

[0204] In some embodiments, the intracorneal implant 200 is configured to be surgically implanted within the cornea of ​​the eye 101. In some embodiments, the intracorneal implant 200 generally comprises a central optic portion configured to receive and retain the optic stem 300 of the device 100, and a peripheral haptic portion including two or more haptics.

[0179]

[0205] In some embodiments, the device 100 comprises an optical stem 300 configured to transmit light from the surrounding environment and / or external light sources along an optical path through the eye 101 and onto the retina. In some embodiments, the optical stem 300 defines an optically transparent pathway for transmitting light from the surrounding environment and / or extraocular light sources to the eye, represented by dashed lines in Figures 1D-1E.

[0180]

[0206] In some embodiments, after implantation, an anterior corneal lamella 102, consisting of previously removed recipient anterior corneal lamella, donor corneal tissue, or corneal tissue scaffold, may be sutured into place to completely or partially cover the cornea and implanted device.

[0181]

[0207] 2A-2E are top perspective view (FIG. 2A), bottom perspective view (FIG. 2B), side view (FIG. 2C), top view (FIG. 2D), and bottom view (FIG. 2E) of an exemplary intracorneal implant 200 of device 100 (shown in FIGS. 1A-1C) according to some embodiments of the present disclosure.

[0182]

[0208] In some embodiments, the intracorneal implant 200 is configured to be surgically implanted within the cornea of ​​the eye. In some embodiments, the intracorneal implant 200 comprises a central optic portion generally including an anchor body 202 and a peripheral haptic portion including two or more haptics 204.

[0183]

[0209] In some embodiments, the intracorneal implant 200 has a convex surface that substantially matches the convex surface of the cornea and defines a surface having opposing convex anterior surface (shown in FIG. 2A , facing the anterior surface of the eye) and concave posterior surface (shown in FIG. 2B , facing the retina of the eye).

[0184]

[0210] In some embodiments, the intracorneal implant 200 is sized to fit within the cornea. For example, the intracorneal implant 200 may have a total span between opposing edges of, for example, 6-12 mm (e.g., 9 mm), a total planar thickness of 0.02-1.50 mm, and a convex surface with a curvature of 32-47 diopters.

[0185]

[0211] Optionally, the central optic comprises a circumferentially continuous annular anchor body 202 defining a central opening 202a configured to receive and retain an optical stem 300. However, in other embodiments, the anchor body 202 may include an integrally formed optical stem 300, as described in further detail below.

[0186]

[0212] The anchor body 202 may be a ring, a rim, a cannula, a cylinder, or any other suitable three-dimensional shape that may define a circular or cylindrical opening and / or form an optical stem (such as optical stem 300, described in detail below), to which the haptics 204 may be attached.

[0187]

[0213] In some embodiments, the intracorneal implant 200 with the anchor body 202 and haptics 204 may be formed of any suitable biocompatible material, such as any metal, metal alloy (e.g., Nitinol, stainless steel, etc.) In some embodiments, the material may be a polymer, such as an acrylate polymer, polycarbonate, polymethylmethacrylate (PMMA), polyvinyl chloride (PVC), polyolefin copolymers, fluoropolymers (e.g., PTFE), polyamide, polyimide, polyester, polyurethane, copolymers thereof, silicone, cross-linked silicone polymers, and combinations thereof.

[0188]

[0214] In some embodiments, all of the components of the implant 200 can be made of the same material. In some embodiments, at least two of the components of the implant 200 are made of different materials. One or more of the materials that make up the intracorneal implant 200 can be transparent, substantially transparent, or optically transparent. One or more of the materials that make up the intracorneal implant 200 can be biocompatible.

[0189]

[0215] In some embodiments, the intracorneal implant 200 may be integrally formed as a unitary intracorneal implant of a single material, or may be assembled from two or more separate components, where each component may be made of a different material. In some embodiments, the intracorneal implant 200, or any portion thereof, may be made of a hard or non-deformable material, a shape memory material, and / or a flexible or deformable material. In some embodiments, the intracorneal implant 200, or any portion thereof, may have a coating of, for example, hydroxyapatite or the like. For example, the anchor body 202 and the haptics 204 may be made of different materials, or alternatively, may be made of the same material with different mechanical properties.

[0190]

[0216] In some embodiments, the peripheral haptics of the implant 200 include two or more angularly spaced haptics 204 extending laterally from the anchor body 202, e.g., from its outer periphery. In some embodiments, the haptics 204 extend outwardly from the outer periphery of the anchor body 202. The haptics 204 may function structurally to center and secure the implanted intracorneal implant 200 in place. Each of the haptics 204 includes a proximal end that connects to the outer periphery of the anchor body 202 and a protruding segment that terminates at a distal end. In some embodiments, between two and six haptics 204 may be used. In some embodiments, the haptics 204 may be split into opposing pairs, each extending outwardly away from the anchor body 202 at opposite ends of the anchor body 202. The haptics 204 may have any suitable shape, size, and profile known in the art. The haptics 204 included in any given intracorneal implant 200 may all be the same or may vary in shape and size.

[0191]

[0217] During implantation of the intracorneal implant 200, each of the haptics 204 may be manipulated to move the center of the intracorneal implant 200 as close as possible to the optical axis of the eye and to ensure that the intracorneal implant 200 has the desired rotational alignment in the XY plane and is fixed in place within the cornea.

[0192]

[0218] In some embodiments, at least one of the haptics 204 comprises one or more openings 206. In some embodiments, each of the haptics 204 comprises a series of spaced apart openings 206 along at least a portion of its length. The openings 206 can be of any suitable shape or size, including any regular shapes and regular polygons (e.g., circle, semicircle, ellipse, square, triangle, hexagon, octagon, and rectangle) and irregular shapes and polygons. The number of openings 206 on each haptic 204 can be between 0 and 20 or more. The openings 206 can be located anywhere on the haptics 204.

[0193]

[0219] In some embodiments, the opening 206 is configured to allow for application of the intracorneal implant 200 within the cornea through the opening 206 and fixation of the intracorneal implant 200 within the surrounding corneal tissue. In this manner, once the intracorneal implant 200 is implanted and the eye heals, the intracorneal implant 200 is substantially fixed in place by the growth and remodeling of the surrounding tissue.

[0194]

[0220] 3A to 3C are schematic diagrams of a cross-sectional side view (FIG. 3A), an exploded perspective view (FIG. 3B), and an exploded side view (FIG. 3C) of an exemplary optical stem 300 of a device 100 of the present disclosure, configured to be implanted within the cornea of ​​an eye and transmit light from the surrounding environment and / or extraocular sources through the eye and onto the retina along an optical path (shown by the dashed line in FIGS. 3B to 3C).

[0195]

[0221] In some embodiments, the optical stem 300 defines an optically transparent pathway for transmitting light from the surrounding environment and / or extraocular sources along an optical path through the eye, and the pathway defined by the optical stem may comprise at least one optical element, such as an optical lens.

[0196]

[0222] In other embodiments, the optical stem 300 comprises an image generator incorporating any suitable image display and / or projection technology, such as a liquid crystal display (LCD) element with optically coupled illumination elements, an LED projector, a laser diode projector, an LED array, etc. In some embodiments, the image generator is configured to receive image data signals from an extraocular source (such as an extraocular imaging device) and generate an optical image signal that is projected posteriorly through the light projection rear port onto the retina of the eye.

[0197]

[0223] In some embodiments, the optical stem 300 is configured to project an image beyond its light projecting posterior port at its posterior end 300b based on light entering a light receiving anterior port at the anterior end 300a of the optical stem that defines the anteriormost end of the intracorneal implant 200 (e.g., when the device 100 is implanted in the eye, the image is projected onto the retina). In some embodiments, the optical stem has a light receiving anterior port at the anterior end 300a that is closest to the anterior surface of the eye. The optical stem extends axially through the cornea to the light projecting posterior port located at the posterior end 300b of the optical stem, closer to the posterior surface of the cornea. In some embodiments, the anterior end 300a of the optical stem defines the anteriormost point of the device 100 and is directly below the anterior surface of the eye, substantially at the level of the anterior surface of the eye, flush with the anterior surface of the eye, or slightly protruding from the anterior surface of the eye. In some embodiments, the anterior end 300a of the optical stem is located close to the anterior surface of the eye, completely or partially under a thin conjunctival flap layer. In some embodiments, at least a portion of the front end of the optical stem 300 is exposed through the anterior surface of the eye and forms a means for receiving an external optical element of the device 100, as described further below.

[0198]

[0224] In some embodiments, the front end 300a of the optical stem may comprise a front surface that functions as an optical element, such as a focusing lens. In some embodiments, the front end 300a is configured to receive one or more external optical elements, as described in more detail below.

[0199]

[0225] In some embodiments, the optical stem 300 includes one or more internal optical and / or imaging components, such as lenses, that aid in providing a focused image to the retina, and the optical components of the optical stem 300 are optically aligned with the light transmissive pathway defined by the optical stem 300. In other embodiments, the optical stem 300 is simply a transparent pathway that allows external light or imaging components to pass through the light projecting rear port and therefrom to be projected onto the retina. In other embodiments, the optical stem 300 includes an image generator incorporating any suitable image display and / or projection technology, such as a liquid crystal display (LCD) element with an optically coupled illuminator element, an LED projector, a laser diode projector, an LED array, and the like. In some embodiments, the image generator is configured to receive image data signals from an extraocular source (such as an extraocular imaging device) and generate an optical image signal that is projected backwards through the light projecting rear port onto the retina of the eye.

[0200]

[0226] In some embodiments, the optical stem 300 comprises at least one internal optical lens 302 (described in further detail with reference to FIGS. 4A-4B ) that may be received within the aperture 202a or, optionally, may be integrally formed with the intracorneal implant 200 in place of the aperture 202a. In some embodiments, the internal optical lens 302 may be configured to fit directly within the aperture 202a of the intracorneal implant 200. In some embodiments, the internal optical lens 302 may be integrally formed with the intracorneal implant 200, e.g., approximately centrally located relative to the anchor body 202, in which case the anchor body 202 does not comprise an aperture 202a.

[0201]

[0227] In some embodiments, the inner optical lens 302 may be configured to fit within a separate lens housing 304, which is configured to be received within the opening 202a of the intracorneal implant 200. The lens housing 304 may comprise a cylinder or tubular portion that houses the inner optical lens 302 through which light passes to project an image onto the retina. The lens housing 304 used herein may be made from any suitable biocompatible material, such as polymethylmethacrylate (PMMA), polysulfone, trimethyl-terminated polydimethylsiloxane (PDMS), polystyrene-polyisobutylene-polystyrene (SIBS), etc. The lens housing 304 may be any size sufficient to accommodate vision, such as allowing an appropriate amount of light to pass through.

[0202]

[0228] In some embodiments, the optical lens 302 may be integrally formed with the lens housing 304. In some embodiments, the lens housing 304 may be integrally formed with the intracorneal implant 200, e.g., approximately centered with respect to the anchor body 202, in which case the anchor body 202 does not include an opening 202a. In some embodiments, both the optical lens 302 and the lens housing 304 may be integrally formed with the intracorneal implant 200, e.g., such that the lens housing 304 and the optical lens 302 are approximately centered with respect to the anchor body 202, in which case the anchor body 202 does not include an opening 202a.

[0203]

[0229] Reference is now made to FIGS. 4A-4B, which illustrate an exemplary internal optical lens 302 of the present disclosure in perspective (FIG. 4A) and side (FIG. 4B) views that may be used in conjunction with device 100.

[0204]

[0230] In some embodiments, the internal optical lens 302 may be a convex lens, a concave lens, a monofocal lens, a multifocal lens, a Fresnel lens, a diffractive lens, a prismatic lens, a focusing lens, or other type of lens that may be used to treat refractive errors (such as myopia, hyperopia, or astigmatism). In some embodiments, the internal optical lens 302, alone or in combination with one or more additional internal and / or external lenses, may be configured to focus an image on the retina.

[0205]

[0231] In some embodiments, the internal optical lens 302 may be integrally formed with the central optic of the intracorneal implant 200, e.g., integrally formed with the anchor body 202, such that the internal optical lens 302 forms an optical lens within the aperture 202a. In other embodiments, the internal optical lens 302 may be formed separately from the intracorneal implant 200 and configured to be received and retained within the aperture 202a, e.g., by mounting the internal optical lens 302 within the aperture 202a using a precision fit, press fit, click fit connector, threaded connection, annular groove and channel engagement, by fusion, by bonding an inner periphery of the anchor body 202 that defines the aperture 202a with a periphery of the internal optical lens 302, and / or any other suitable mounting method or technique. In some embodiments, the internal optical lens 302 may be configured to be mounted within the aperture 202a in a sealed connection or engagement configured to prevent the passage or movement of biological agents or other contaminants by the connection between the internal optical lens 302 and the aperture 202a.

[0206]

[0232] Reference is now made to Figures 5A through 5D, which show an exemplary intracorneal lens housing 304 of the present disclosure that may be used in conjunction with device 100 and internal optical lens 302, in a front perspective view (Figure 5A), a rear perspective view (Figure 5B), a side view (Figure 5C), and a top view (Figure 5D).

[0207]

[0233] In some embodiments, the lens housing 304 defines any substantially cylindrical or tubular body configured to be attached or mounted within the anchor body 202, e.g., within the opening 202a, and configured to be oriented relative to the eye such that the lens housing 304 defines a light-transmitting pathway for transmitting light from the surrounding environment and / or extraocular light sources along an optical path through the eye. In some embodiments, the lens housing 304 may comprise a base portion 304a configured to be received and mounted within the opening 202a of the anchor body 202, e.g., using a precision fit, press fit, click fit, annular groove and channel engagement, threaded engagement, by fusion, by bonding an inner periphery of the anchor body 202 that defines the opening 202a to a periphery of the base portion 304a, and / or any other suitable mounting method or technique. In some embodiments, the base portion 304a may be configured to be mounted within the opening 202a in a sealing engagement or mating configured to prevent the passage or movement of biological agents or other contaminants by mating of the base portion 304a with the opening 202a.

[0208]

[0234] In some embodiments, the lens housing 304 includes a larger diameter lens retaining portion 304b configured to receive and retain the inner optical lens 302. In some embodiments, the lens housing 304 may be configured to be mounted within the opening 202a in a sealing connection or engagement configured to prevent the passage or transfer of biological agents or other contaminants by the connection between the lens housing 304 and the opening 202a.

[0209]

[0235] In some embodiments, the lens housing 304 may be formed of any suitable biocompatible material, such as any metal, metal alloy (e.g., Nitinol, stainless steel, etc.) In some embodiments, the material may be a polymer, such as an acrylate polymer, polymethylmethacrylate (PMMA), polyvinyl chloride (PVC), polyolefin copolymers, fluoropolymers (e.g., PTFE), polyamide, polyimide, polyester, polyurethane, copolymers thereof, silicone, cross-linked silicone polymers, and combinations thereof.

[0210]

[0236] It should be noted that any two or more of the components of the intracorneal implant 200, including the anchor body 202 and the haptics 204, and / or the components of the optical stem 300, including the optical lens 302 and the lens housing 304, may be constructed as a single unit or piece from a single material using any suitable manufacturing process, including but not limited to molding, additive printing, and the like.

[0211]

[0237] 6 is an exploded perspective view of an exemplary device 100 of the present disclosure including an intracorneal implant 200 and an optical stem 300 configured to transmit light from the surrounding environment and / or extraocular sources through the eye along an optical path (shown by the dashed line) onto the retina. In some embodiments, the device 100 further includes an optional external optical element that is extraocular, including, for example, an end plate 310 and / or an external optical lens 316, which may be attached to the front end 300a of the optical stem 300, as described in more detail below. In some embodiments, the external optical lens 316 is integrally formed with the end plate 310.

[0212]

[0238] 7A-7D, which show an exemplary external front end plate 310 that may be further included within device 100 in a front perspective view (FIG. 7A), a rear perspective view (FIG. 7B), a side view (FIG. 7C), and a top view (FIG. 7D).

[0213]

[0239] In some embodiments, the front end 300a of the optical stem 300 may be configured to mount one or more optional external optical elements of the device 100, thereby providing the device 100 with an external optical lens 316 that may be easily accessible post-operatively for purposes of optical tuning and / or upgrade, e.g., to adjust the refractive or focusing power of the device 100.

[0214]

[0240] As described above and further below, in some embodiments, upon implantation of the device 100, the leading end 300a of the optical stem 300 may be configured to be located substantially on, flush with, or slightly protruding from the anterior surface of the eye. In some embodiments, the leading end 300a of the optical stem 300 is located proximate to the anterior surface of the eye, completely or partially under a thin conjunctival flap layer. In some embodiments, at least a portion of the leading end 300a of the optical stem 300 is exposed to the surrounding environment through the anterior surface of the eye.

[0215]

[0241] In all such embodiments, the present disclosure provides an end plate 310 that may be removably and / or adjustably attachable to the front end 300a, e.g., magnetically removably attachable to the front end 300a. In some embodiments, the end plate 310 may be removably attachable to the front end 300a, e.g., magnetically removably attachable to the front end 300a. In some embodiments, the end plate 310 may be adjustably attachable to the front end 300a, e.g., by rotating the end plate 310 about its central axis to adjust the optical properties of an external lens received therein. In some embodiments, the end plate 310 may be configured to be attached to the front end 300a in a manner that ensures a particular desired angular orientation of the end plate 310 relative to the front end 300a.

[0216]

[0242] In some embodiments, the end plate 310 may have a convex surface that substantially matches the convex surface of the anterior surface of the cornea and define a generally circular curved body having opposing convex anterior surface 310a and concave posterior surface 310b. In some embodiments, the end plate 310 has a centrally located raised annular flange 312 on its posterior surface 310b that defines an opening 314 therethrough. In some embodiments, the end plate 310 may be attachable to the anterior end 300a and oriented relative to the eye such that the end plate 310 defines an optically transparent pathway through which light from the surrounding environment and / or extraocular light sources may be transmitted along an optical path through the eye.

[0217]

[0243] Continuing with reference to FIGS. 7A-7D and 8A-8B, in some embodiments, the front end plate 310 may be configured to receive one or more optical elements, such as an external optical lens 316. In some embodiments, the external optical lens 316 may be a rotationally asymmetric lens configured to adjust the optical properties of the lens 316 with respect to an optical axis defined by an optical path shown in dashed line in FIG. 6. The external optical lens 316 may be removably received and adjusted within the opening 314 of the end plate 310 (e.g., by rotating about its central axis). Alternatively, the external optical lens 316 may be fixedly mounted within the opening 314 of the end plate 310, and the end plate 310 may be adjusted about its central axis when attached to the front end 300a of the optical stem 300. In some embodiments, the external optical lens 316 may be oriented within the front end plate 310 to adjust and fine-tune the optical properties of the lens 316 with respect to an optical axis defined by an optical path shown in dashed line in FIG. 6. In some embodiments, the end plate 310 can be adjusted relative to the front end 300a of the optical stem 300 using an appropriate tool, thereby changing or adjusting and fine-tuning the optical properties of the lens 316 relative to the optical axis defined by the optical path shown in dashed line in FIG. 6.

[0218]

[0244] In some embodiments, one or more of the end plate 310 and the external optical lens 316 may be custom-made for a particular patient to adjust and correct any imperfections resulting from the optical specifications of the implanted device. These components may be fitted and adjusted in situ after implantation to modify or fine-tune the optical and focusing power of the external optical lens 316 according to the needs of a particular patient.

[0219]

[0245] In some embodiments, one or more of the end plate 310 and the external lens 316 may be tinted or feature a design configured for cosmetic and / or natural appearance to the eye (e.g., the front end of the end plate 310 may be tinted to resemble / mimic the natural color of the iris).

[0220]

[0246] It should be noted that the end plate 310 and external optical lens 316 may be constructed as a single unit or piece from a single material using any suitable manufacturing process, including but not limited to molding, laminate printing, and the like.

[0221]

[0247] Reference is made to FIGS. 9A-9D, which illustrate an exemplary embodiment of the device 110 of the present disclosure in exploded perspective (FIG. 9A), exploded side (FIG. 9B), and cross-sectional (FIGS. 9C and 9D) views, including an intracorneal implant 210, an internal optical lens 322, an end plate 330, and an external optical lens 326. In some embodiments, the intracorneal implant 210 is configured to be surgically implanted into the cornea of ​​an eye. In some embodiments, the intracorneal implant 210 includes a central optic portion generally including a lens housing body 212 and a peripheral haptic portion including two or more haptics 204 similar to those described with reference to FIGS. 2A-2E. In some embodiments, the lens housing body 212 defines a cylindrical or tubular body that houses the lens 322 oriented in a vision-promoting relationship with respect to the eye through which light passes to project an image onto the retina, and includes a forwardly raised annular flange 212a. In some embodiments, the leading edge of the flange 212a defines the anterior-most end 210a of the intracorneal implant 210.

[0222]

[0248] In some embodiments, the intracorneal implant 210 with the lens housing body 212 and haptics 204 may be formed of any suitable biocompatible material, such as any metal, metal alloy (e.g., Nitinol, stainless steel, etc.). In some embodiments, the material may be a polymer, such as an acrylate polymer, polymethylmethacrylate (PMMA), polyvinyl chloride (PVC), polyolefin copolymers, fluoropolymers (e.g., PTFE), polyamide, polyimide, polyester, polyurethane, copolymers thereof, silicone, cross-linked silicone polymers, and combinations thereof.

[0223]

[0249] In some embodiments, the internal optical lens 322 may be integrally formed with the central optic of the intracorneal implant 210, e.g., integrally formed with the lens housing body 212. In other embodiments, the optical lens 322 may be formed separately from the intracorneal implant 210 and configured to be received and retained within the lens housing body 212, e.g., by using a precision fit, a press fit, a click-fit connector, an annular groove and channel engagement, a threaded connection, by fusion, by bonding an inner periphery of the lens housing body 212 to a periphery of the optical lens 322, and / or by mounting the optical lens 322 within the lens housing body 212 using any other suitable mounting method or technique. In some embodiments, the optical lens 322 may be configured to be mounted within the lens housing body 212 in a sealed connection or engagement configured to prevent the passage or transfer of biological agents or other contaminants through the connection between the optical lens 322 and the lens housing body 212.

[0224]

[0250] In some embodiments, upon implantation, the anterior end 210a of the lens housing body 212, which defines the anterior-most point of the device 110, is directly below the anterior surface of the eye, substantially at the level of the anterior surface of the eye, flush with the anterior surface of the eye, or slightly protrudes from the anterior surface of the eye. In some embodiments, the anterior end 210a of the lens housing body 212 is located proximate to the anterior surface of the eye, completely or partially under a thin conjunctival flap layer. In some embodiments, at least a portion of the anterior end 210a of the lens housing body 212 is exposed through the anterior surface of the eye and forms a means for receiving external optical elements of the device 110, such as an end plate 330 and / or one or more external lenses, which may be easily accessible post-operatively, for example, to adjust the optical or focusing power of the device 110, for adjustment and / or upgrade purposes.

[0225]

[0251] FIG. 9D shows a cross-sectional view of an exemplary variation of device 110 in which external lens 327 is integrally formed with end plate 331.

[0226]

[0252] 10A-10C, which show an exemplary embodiment of the device 120 of the present disclosure in an exploded perspective view (FIG. 10A), an exploded side view (FIG. 10B), and a cross-sectional view (FIG. 10C) with an intracorneal implant 220, an internal optical lens 322, an end plate 330, and an external optical lens 326. In some embodiments, the intracorneal implant 220 is configured to be surgically implanted in the cornea of ​​an eye. In some embodiments, the intracorneal implant 220 generally includes a central optical portion including a lens housing body 222 and a peripheral haptic portion including two or more haptics 204 similar to those described with reference to FIGS. 2A-2E. In some embodiments, the lens housing body 222 defines a cylinder or tubular body that houses the lens 322 oriented with respect to the eye through which light passes to project an image onto the retina, and includes a forwardly raised annular flange 222a. In some embodiments, the front end or leading edge of the flange 222a defines the front-most end 220a of the intracorneal implant 220.

[0227]

[0253] In some embodiments, the intracorneal implant 220 with the lens housing body 222 and haptics 204 may be formed of any suitable biocompatible material, such as any metal, metal alloy (e.g., Nitinol, stainless steel, etc.). In some embodiments, the material may be a polymer, such as an acrylate polymer, polymethylmethacrylate (PMMA), polyvinyl chloride (PVC), polyolefin copolymers, fluoropolymers (e.g., PTFE), polyamide, polyimide, polyester, polyurethane, copolymers thereof, silicone, cross-linked silicone polymers, and combinations thereof.

[0228]

[0254] In some embodiments, the internal optical lens 322 may be integrally formed with a central optic portion of the intracorneal implant 220, e.g., integrally formed with the lens housing body 222. In other embodiments, the optical lens 322 may be formed separately from the intracorneal implant 220 and configured to be received and retained within the lens housing body 222, e.g., using a precision fit, a press fit, a click-fit connector, an annular groove and channel engagement, a threaded connection, by fusion, by bonding an inner periphery of the lens housing body 222 to a periphery of the optical lens 322, and / or by mounting the optical lens 322 within the lens housing body 222 using any other suitable mounting method or technique. In some embodiments, the optical lens 322 may be configured to be mounted within the lens housing body 222 in a sealed connection or engagement configured to prevent the passage or transfer of biological agents or other contaminants through the connection between the optical lens 322 and the lens housing body 222.

[0229]

[0255] In some embodiments, upon implantation, the anterior end 220a of the lens housing body 222, which defines the anterior-most point of the device 120, is directly below the anterior surface of the eye, substantially at the level of the anterior surface of the eye, flush with the anterior surface of the eye, or slightly protrudes from the anterior surface of the eye. In some embodiments, the anterior end 220a of the lens housing body 222 is located proximate to the anterior surface of the eye, completely or partially under a thin conjunctival flap layer. In some embodiments, at least a portion of the anterior end of the lens housing body 222 is exposed through the anterior surface of the eye and forms a means for receiving external optical elements of the device 120, such as an end plate 330 and / or one or more external optical lenses 326, which may be easily accessible post-operatively, for example, to adjust the optical or focusing power of the device 120, for adjustment and / or upgrade purposes.

[0230]

[0256] In some embodiments, the device 120 further comprises a magnetic coupling system configured to magnetically and removably attach the end plate 330 to the front end 220a. In some embodiments, the end plate 330 may be removably and rotatably attachable to the front end 220a, e.g., magnetically and removably and rotatably attachable to the front end 220a. In some embodiments, the flange 222a may comprise an annular magnetic ring 223 located proximate the front end of the flange 222a. Similarly, the end plate 330 may comprise an annular magnetic ring 224 located proximate the light projecting rear port of the end plate 330. Thus, when the end plate 330 is placed around the front end 220a of the device 120, the magnetic rings 223 and 224 attract each other and act to secure the end plate 330 to the front end 220a of the device 120.

[0231]

[0257] 11A-11D, which show an exemplary embodiment of the device 130 of the present disclosure, including an intracorneal implant 230, an internal optical lens 332, an end plate 330, and an external optical lens 326, in exploded perspective (FIG. 11A), exploded side (FIG. 11B), and cross-sectional (FIGS. 11C and 11D) views. In some embodiments, the intracorneal implant 230 is configured to be surgically implanted into the cornea of ​​the eye. In some embodiments, the intracorneal implant 230 generally includes a central optic portion including an internal optical lens 332 and a peripheral haptic portion including two or more haptics 204 similar to those described with reference to FIGS. 2A-2E. In some embodiments, the internal optical lens 332 may be integrally formed with the central portion of the intracorneal implant 230. In other embodiments, the optical lens 332 may be formed separately from the intracorneal implant 230 and configured to be received and retained within the central optic of the intracorneal implant 230, for example, using a precision fit, a press fit, an annular groove and channel engagement, a click-fit connector, a threaded connection, by fusion, by bonding an inner periphery of the central optic of the intracorneal implant 230 to a periphery of the optical lens 332, and / or by mounting the optical lens 332 using any other suitable mounting method or technique. In some embodiments, the optical lens 332 may be configured to be mounted within the central optic of the intracorneal implant 230 in a sealed connection or engagement configured to prevent the passage or migration of biological agents or other contaminants by the connection between the optical lens 332 and the central optic of the intracorneal implant 230.

[0232]

[0258] In some embodiments, the device 130 further comprises a separate tubular extension 232 that defines a cylinder or tubular body extending forward from a central optic portion of the intracorneal implant 230 oriented relative to the eye through which light passes to project an image onto the retina. In some embodiments, a front end or leading edge of the tubular extension 232 defines a front-most end 230a of the intracorneal implant 230.

[0233]

[0259] In some embodiments, the intracorneal implant 230 with the tubular extensions 232 and haptics 204 may be formed of any suitable biocompatible material, such as any metal, metal alloy (e.g., Nitinol, stainless steel, etc.). In some embodiments, the material may be a polymer, such as an acrylate polymer, polymethylmethacrylate (PMMA), polyvinyl chloride (PVC), polyolefin copolymers, fluoropolymers (e.g., PTFE), polyamide, polyimide, polyester, polyurethane, copolymers thereof, silicone, cross-linked silicone polymers, and combinations thereof.

[0234]

[0260] In some embodiments, when implanted, the anterior end 230a of the tubular extension 232, which defines the anterior-most point of the intracorneal implant 230, is directly below the anterior surface of the eye, substantially at the level of the anterior surface of the eye, flush with the anterior surface of the eye, or slightly protrudes from the anterior surface of the eye. In some embodiments, the anterior end 230a of the tubular extension 232 is located close to the anterior surface of the eye, completely or partially under a thin conjunctival flap layer. In some embodiments, at least a portion of the anterior end of the tubular extension 232 is exposed through the anterior surface of the eye and forms a means for receiving external optical elements of the device 130, such as the end plate 330 and / or one or more external optical lenses 326, which may be easily accessible after surgery, for example, to adjust the refractive or focusing power of the device 130, for adjustment and / or upgrade purposes.

[0235]

[0261] In some embodiments, the tubular extension 232 may be coupled to the central optic of the intracorneal implant 230 such that the through bore defined by the tubular extension 232 is oriented with respect to the eye to create a light-transmitting pathway for the transmission of light. In some embodiments, the tubular extension 232 may be coupled to the central optic of the intracorneal implant 230, for example, by precision fit, press fit, click fit, annular groove and channel engagement, threaded engagement, by fusion, by bonding the inner periphery of the tubular extension 232 to the periphery of the central optic of the intracorneal implant 230, and / or by any other suitable attachment method or technique. In some embodiments, as seen in the variation shown in the cross-sectional view of FIG. 11D, the tubular extension 232 may be coupled to the central optic of the intracorneal implant 230, for example, by a click system with an annular protrusion 232a on the inner periphery of the tubular extension 232 configured to engage with a corresponding annular groove on the periphery of the central optic of the intracorneal implant 230 (or vice versa). In some embodiments, the tubular extension 232 may be coupled to the central optic of the intracorneal implant 230 in a sealed bond or engagement configured to prevent the passage or migration of biological agents or other contaminants by the bond between the tubular extension 232 and the central optic of the intracorneal implant 230.

[0236]

[0262] In some embodiments, the device 130 further comprises a magnetic coupling system configured to magnetically and removably attach the end plate 330 to the front end 230a. In some embodiments, the end plate 330 may be removably and rotatably attachable to the front end 230a, e.g., magnetically and removably attachable to the front end 230a. In some embodiments, the tubular extension 232 may comprise an annular magnetic ring located proximate the front end of the tubular extension 232. Similarly, the end plate 330 may comprise an annular magnetic ring located proximate the light projection rear port of the end plate 330. Thus, when the end plate 330 is placed around the front end 230a of the device 130, the magnetic rings attract each other and act to secure the end plate 330 to the front end 230a of the device 130.

[0237]

[0263] 11E-11G illustrate exemplary tubular extensions 233, 234, 235 with a magnetic coupling system configured to magnetically removably attach end plate 330 to front end 230a.

[0238]

[0264] In some embodiments, the exemplary tubular extension 233 (FIG. 11E) may include one or more, e.g., one, two, three, four, five, six or more, e.g., substantially evenly annularly spaced magnets 236, 237, 238 at the front end of the tubular extension 233. Similarly, the end plate 330 may include a corresponding set of annularly spaced magnets located proximate the light projecting rear port of the end plate 330. Thus, when the end plate 330 is placed around the front end 230a of the device 130, the magnets attract each other and act to secure the end plate 330 to the front end 230a of the device 130.

[0239]

[0265] In some embodiments, the exemplary tubular extension 234 (FIG. 11F) may include one or more, e.g., one, two, three, four, five, six or more, e.g., annularly spaced magnets 236, 237, 238, asymmetrically disposed at the front end of the tubular extension 233. Similarly, the end plate 330 may include a corresponding set of magnets located proximate the light projecting rear port of the end plate 330. The asymmetric arrangement is configured to ensure a particular desired angular arrangement of the end plate 330 relative to the tubular extension 234. Thus, when the end plate 330 is disposed about the front end 230a of the device 130, the magnets attract each other and act to secure the end plate 330 to the front end 230a of the device 130 in a particular desired angular arrangement.

[0240]

[0266] In some embodiments, the exemplary tubular extension 235 (FIG. 11G) may include one or more, e.g., one, two, three, four, five, six or more, e.g., annularly spaced magnets 236, 237, 238 at a front end of the tubular extension 235. Similarly, the end plate 330 may include a corresponding set of annularly spaced magnets located proximate the light projecting rear port of the end plate 330. The tubular extension 235 may also include an indexing pin 239 protruding from the front end of the tubular extension 235 and configured to engage with a corresponding opening located proximate the light projecting rear port of the end plate 330. The engagement of the indexing pin 239 with the corresponding opening is configured to lock a particular desired angular orientation of the end plate 330 relative to the tubular extension 235. Thus, when end plate 330 is placed around front end 230a of device 130, the magnets attract each other and act to secure end plate 330 to front end 230a of device 130 while indexing pin 239 ensures a particular desired angular orientation.

[0241]

[0267] 12A-12C, which show an exemplary embodiment of the device 140 of the present disclosure in an exploded perspective view (FIG. 12A), an exploded side view (FIG. 12B), and a cross-sectional view (FIG. 12C), comprising an intracorneal implant 240, an internal optical lens 342, an end plate 330, and an external optical lens 326. In some embodiments, the intracorneal implant 240 is configured to be surgically implanted in the cornea of ​​the eye. In some embodiments, the intracorneal implant 240 comprises a central optic portion comprising an annular anchor body 242 defining a central opening 242a configured to receive and hold the internal optical lens 342. In some embodiments, the anchor body 242 may define a circumferentially continuous annular ring or may have openings 242b on its sides. In some embodiments, the peripheral haptics include two or more haptics 204 similar to those described with reference to FIGS. 2A-2E.

[0242]

[0268] The anchor body 242 can be a ring, a rim, a cannula, a cylinder, or any other suitable three-dimensional shape that can define a circular or cylindrical opening and to which the haptics 204 can be attached.

[0243]

[0269] In some embodiments, the internal optical lens 342 may be integrally formed with the central optic of the intracorneal implant 240, e.g., integrally formed with the anchor body 242, such that the optical lens 342 forms an optical lens within the aperture 242a. In other embodiments, the optical lens 342 may be formed separately from the intracorneal implant 240 and configured to be received and retained within the aperture 242a, e.g., by mounting the optical lens 342 within the aperture 242a using a precision fit, press fit, click fit, threaded connection, annular groove and channel engagement, by fusion, by bonding an inner periphery of the anchor body 242 that defines the aperture 242a with a periphery of the internal optical lens 342, and / or any other suitable mounting method or technique. In some embodiments, the optical lens 342 may be configured to be mounted within the aperture 242a in a sealed connection or engagement configured to prevent the passage or movement of biological agents or other contaminants by the connection between the optical lens 342 and the aperture 242a.

[0244]

[0270] In some embodiments, the internal optical lens 342 may be integrally formed with the central optic of the intracorneal implant 240. In other embodiments, the optical lens 342 may be formed separately from the intracorneal implant 240 and configured to be received and retained within the central optic of the intracorneal implant 240, for example, using a precision fit, press fit, click fit, threaded connection, by fusion, by bonding an inner periphery of the central optic of the intracorneal implant 240 to a periphery of the optical lens 342, and / or by mounting the optical lens 342 using any other suitable mounting method or technique. In some embodiments, the optical lens 342 may be configured to be mounted within the central optic of the intracorneal implant 240 in a sealed connection or engagement configured to prevent the passage or transfer of biological agents or other contaminants by the connection between the optical lens 342 and the central optic of the intracorneal implant 240.

[0245]

[0271] In some embodiments, the device 140 further comprises a separate tubular extension 244 that defines a cylinder or tubular body extending forward from a central optic portion of the intracorneal implant 240 oriented relative to the eye through which light passes to project an image onto the retina. In some embodiments, a front end or leading edge of the tubular extension 244 defines an anterior-most end 240a of the intracorneal implant 240.

[0246]

[0272] In some embodiments, the intracorneal implant 240 with the anchor body 242 and haptics 204 may be formed of any suitable biocompatible material, such as any metal, metal alloy (e.g., Nitinol, stainless steel, etc.). In some embodiments, the material may be a polymer, such as an acrylate polymer, polymethylmethacrylate (PMMA), polyvinyl chloride (PVC), polyolefin copolymers, fluoropolymers (e.g., PTFE), polyamide, polyimide, polyester, polyurethane, copolymers thereof, silicone, cross-linked silicone polymers, and combinations thereof.

[0247]

[0273] In some embodiments, when implanted, the anterior end 240a of the tubular extension 244, which defines the anterior-most point of the intracorneal implant 240, is directly below the anterior surface of the eye, substantially at the level of the anterior surface of the eye, flush with the anterior surface of the eye, or slightly protrudes from the anterior surface of the eye. In some embodiments, the anterior end 240a of the tubular extension 244 is located close to the anterior surface of the eye, completely or partially under a thin conjunctival flap layer. In some embodiments, at least a portion of the anterior end of the tubular extension 244 is exposed through the anterior surface of the eye and forms a means for receiving external optical elements of the device 140, such as the end plate 330 and / or one or more external optical lenses 326, which may be easily accessible post-operatively, for example, to adjust the refractive or focusing power of the device 140 for adjustment and / or upgrade purposes.

[0248]

[0274] In some embodiments, the tubular extension 244 may be coupled to the central optic of the intracorneal implant 240 such that a through bore defined by the tubular extension 244 is oriented with respect to the eye to create an optically transparent pathway for the transmission of light. In some embodiments, the tubular extension 244 may be coupled to the central optic of the intracorneal implant 240 using, for example, a precision fit, a press fit, a threaded connection, a click-fit connector, by fusion, by adhesion of the inner periphery of the tubular extension 244 to the periphery of the central optic of the intracorneal implant 240, and / or any other suitable attachment method or technique. In some embodiments, the tubular extension 244 may be coupled to the central optic of the intracorneal implant 240 by circumferentially engaging the anterior portion of the optical lens 342, for example, using a precision fit, a press fit, a threaded coupling, by annular groove and channel engagement, by a click system, by fusion, by bonding an inner periphery of the tubular extension 244 to the periphery of the central optic of the intracorneal implant 240, and / or by any other suitable attachment method or technique. In some embodiments, the tubular extension 244 may be coupled to the central optic of the intracorneal implant 240 in a sealed coupling or engagement configured to prevent the passage or migration of biological agents or other contaminants by the coupling of the tubular extension 244 to the central optic of the intracorneal implant 240.

[0249]

[0275] 13A-13F, which illustrate functional steps in a process 1300 for the production of an exemplary pre-treated corneal tissue scaffold derived from a donor cornea.

[0250]

[0276] The particular sequence of steps depicted in connection with process 1300 is not intended to be limiting. Other sequences of steps may be performed in accordance with alternative embodiments without departing from the teachings of the present disclosure. For example, alternative embodiments of the present invention may perform the steps outlined above in a different order or in parallel. Furthermore, individual steps may include multiple sub-steps that may be performed in various orders as desired. Furthermore, additional steps may be added or removed depending on the particular application.

[0251]

[0277] In some embodiments, the corneal tissue scaffold may be configured for use with one or more of the devices of the present disclosure, such as device 100 (described with reference to FIGS. 1A-1C, 3D-3E, and 6), device 110 (described with reference to FIGS. 9A-9D), 120 (described with reference to FIGS. 10A-10C), 130 (described with reference to FIGS. 11A-11D), and / or 140 (described with reference to FIGS. 12A-12C).

[0252]

[0278] In some embodiments, the corneal tissue scaffold of the present disclosure may include various compositions of corneal layers in different regions thereof. For example, the corneal tissue scaffold of the present disclosure may include a substantially light-impermeable (e.g., having a thickness of about 10-50 μm) very thin corneal tissue layer in a central, substantially transparent region thereof. In some embodiments, the very thin layer includes at least the pre-Descemet layer. In some embodiments, the very thin layer includes the pre-Descemet layer in addition to the Descemet membrane. In some embodiments, the very thin layer includes the pre-Descemet layer, the Descemet membrane, and the endothelium. Thus, the generally circular central region or central portion of the corneal tissue scaffold may include (i) only the pre-Descemet layer, or (ii) a combination of the pre-Descemet layer and the Descemet membrane, or (iii) a combination of the pre-Descemet layer, the Descemet membrane, and the endothelium. Thus, in some embodiments, the central region of the corneal tissue scaffold is configured to be substantially light transparent and to lie along the optical path of a device of the present disclosure configured to transmit light from the surrounding environment and / or external light sources through the eye and onto the retina along the optical path. In some embodiments, regions of the corneal tissue scaffold surrounding the central substantially transparent region may have corneal layers of differing composition, including at least a portion of the stromal layer, pre-Descemet's layer, Descemet's membrane, and / or endothelium.

[0253]

[0279] Continuing with reference to FIG. 13A, in step 1302, process 1300 may begin at step 1302 by receiving a donor cornea 1320, as shown in FIG. 13B.

[0254]

[0280] In step 1304, as shown in FIG. 13C, deep lamellar dissection (e.g., pneumatic, hydro-assisted, viscoelastic-assisted, and / or manual dissection) is performed in the donor cornea 1320 to form an air bubble 1326 that separates the posterior stroma from a very thin layer 1327 of substantially optically transparent corneal tissue having a thickness of about 10-50 μm. In some embodiments, the thin layer 1327 includes at least the pre-Descemet's layer. In some embodiments, the thin layer 1327 includes the pre-Descemet's layer in addition to the Descemet's membrane. In some embodiments, the thin layer 1327 includes the pre-Descemet's layer, Descemet's membrane, and endothelium.

[0255]

[0281] In step 1306, a partial thickness drilling and anterior keratectomy is performed in the stromal layer of the donor cornea 1320, removing the anterior corneal lamella 1322 leaving the posterior corneal layer 1324, as shown in FIG. 13D.

[0256]

[0282] In step 1308, the deep posterior stroma (eg, in or around the area above the air bubble 1326) is removed while keeping the thin posterior layer 1327 intact to create a recess 1328, as shown in FIG. 13E.

[0257]

[0283] In step 1310, a full thickness drilling is performed to remove the entire corneal tissue scaffold 1329 with the posterior stroma 1324 and separated lamina 1327 from the donor cornea 1320, as shown in FIG. 13F.

[0258]

[0284] In some embodiments, optionally, anterior corneal lamella 1322, which has been removed as shown in FIG. 13D, is used to construct a pre-assembled system of the present disclosure.

[0259]

[0285] In some embodiments, the corneal tissue scaffold 1329 is then pre-treated using any one or more suitable pre-treatment methods and techniques to stabilize and protect the corneal tissue scaffold 1329 during preparation, storage, and transportation.

[0260]

[0286] Next, in step 1312, the corneal tissue scaffold obtained in step 1310 may be decontaminated, dehydrated, sterilized, and packaged for use by surgeons and other medical professionals, as described in further detail herein.

[0261]

[0287] In some embodiments, further processing methods and techniques according to the present invention may include, but are not limited to, dehydration, freeze-drying, plasticization, gelation, dehydration heat treatment, mechanical treatment, compression, sterilization, and the like.

[0262]

[0288] In some embodiments, pre-treatment prevents the corneal tissue scaffold 1329 from decomposing, spoiling, infecting, and / or breaking during storage and transport, and allows the corneal tissue scaffold 1329 to be stored at room temperature or below room temperature. In some embodiments, pre-treatment also helps maintain the corneal tissue scaffold 1329 to have similar material properties as living or hydrated or processed tissue. In some embodiments, pre-treatment allows the corneal tissue scaffold 1329 to be directly implanted into a recipient subject after removal from the package with no or minimal further processing.

[0263]

[0289] 14A-14D illustrate an exemplary process 1400 for constructing a pre-assembled system 1411 of the present disclosure including a corneal tissue scaffold with a pre-mounted device of the present disclosure. The corneal tissue scaffold may be the exemplary corneal tissue scaffold 1329 described with reference to FIGS. 13A-13F, and the device may be any one of the exemplary devices 100 (described with reference to FIGS. 1A-1C, 3D-3E, and 6), 110 (described with reference to FIGS. 9A-9D), 120 (described with reference to FIGS. 10A-10C), 130 (described with reference to FIGS. 11A-11D), and / or 140 (described with reference to FIGS. 12A-12C).

[0264]

[0290] The particular sequence of steps depicted in connection with process 1400 is not intended to be limiting. Other sequences of steps may be performed in accordance with alternative embodiments without departing from the techniques of the present disclosure. For example, alternative embodiments of the present invention may perform the steps outlined above in a different order or in parallel. Furthermore, individual steps may include multiple sub-steps that may be performed in various orders as desired. Furthermore, additional steps may be added or removed depending on the particular application.

[0265]

[0291] Continuing with reference to FIG. 14A, process 1400 begins at step 1402 by receiving the device 100-140 and the corneal tissue scaffold 1329, as shown in FIG. 14B.

[0266]

[0292] In step 1404, the devices 100-140 are attached to a corneal tissue scaffold 1329, as shown in FIG. 14C.

[0267]

[0293] In step 1406, as shown in FIG. 14D, an anterior corneal lamella 1420 previously removed from the donor cornea (see, for example, the discussion with reference to FIG. 13D) is sutured 1426 into place.

[0268]

[0294] 15A to 15F show functional steps in an exemplary process 1500 for surgically implanting an assembled system of the present disclosure, such as the exemplary assembled system 1411 described with reference to FIGS. 14A to 14D, into a recipient's cornea.

[0269]

[0295] The particular sequence of steps depicted in connection with process 1500 is not intended to be limiting. Other sequences of steps may be performed in accordance with alternative embodiments without departing from the teachings of the present disclosure. For example, alternative embodiments of the present invention may perform the steps outlined above in a different order or in parallel. Furthermore, individual steps may include multiple sub-steps that may be performed in various orders as desired. Furthermore, additional steps may be added or removed depending on the particular application.

[0270]

[0296] Also, various healing and / or tissue regeneration steps that may actually be necessary or desirable between some of the various steps of this exemplary process have been omitted for the sake of brevity.

[0271]

[0297] Continuing with reference to FIG. 15A, process 1500 begins at step 1502 by performing a full-thickness drilling on a recipient cornea 1520 to remove anterior corneal lamella 1522 and create a hollow opening 1523, as shown in FIG. 15B.

[0272]

[0298] In step 1504, the assembled system 1411 may be implanted and sutured (1526) into an opening 1523 in the cornea 1520, as shown in FIG. 15C.

[0273]

[0299] In step 1506, a thin conjunctival flap layer 1523 may be placed over the anterior surface of the cornea 1520 to cover the implanted assembled system 1411, as shown in FIG. 15D.

[0274]

[0300] In step 1508, a central opening 1524 may be formed in the thin conjunctival flap layer 1523 to accommodate the front end of the optical stem of the implanted device, such that the front end of the optical stem is directly below the anterior surface of the eye, substantially at the same level as the anterior surface of the eye, flush with the anterior surface of the eye, or slightly protrudes from the anterior surface of the eye, as shown in FIG. 15E.

[0275]

[0301] In step 1510, optional external optical elements including, for example, an end plate 1510 and an external optical lens 1516 may be attached to the front end of the device 100-140 that is part of the assembled system 1411, as shown in FIG. 15F.

[0276]

[0302] 16A-16G show functional steps in an exemplary process 1600 for surgical implantation of a pretreated corneal tissue scaffold, such as the exemplary corneal tissue scaffold 1329 described with reference to FIGS. 13A-13F, followed by implantation of a device of the present technology.

[0277]

[0303] The particular sequence of steps depicted with respect to process 1600 is not intended to be limiting. Other sequences of steps may be performed in accordance with alternative embodiments without departing from the teachings of the present disclosure. For example, alternative embodiments of the present invention may perform the steps outlined above in a different order or in parallel. Furthermore, individual steps may include multiple sub-steps that may be performed in various orders as desired. Furthermore, additional steps may be added or removed depending on the particular application.

[0278]

[0304] Also, various healing and / or tissue regeneration steps that may actually be necessary or desirable between some of the various steps of this exemplary process have been omitted for the sake of brevity.

[0279]

[0305] After full thickness perforation of the recipient cornea, implantation of an exemplary corneal tissue scaffold 1329 is performed, followed by implantation of a device 100-140 of the present disclosure, which can be any one of exemplary devices 100 (described with reference to FIGS. 1A-1C, 3D-3E, and 6), 110 (described with reference to FIGS. 9A-9D), 120 (described with reference to FIGS. 10A-10C), 130 (described with reference to FIGS. 11A-11D), and / or 140 (described with reference to FIGS. 12A-12C).

[0280]

[0306] Continuing with reference to FIG. 16A, the process 1600 begins at step 1602 where a corneal tissue scaffold 1329 is implanted and sutured 1626 into a recess 1621 created by full-thickness drilling of a recipient cornea 1620, as shown in FIG. 16B.

[0281]

[0307] The recipient cornea 1620 may be prepared by first performing a partial drilling and anterior keratectomy in the stromal layer to remove the recipient anterior corneal lamella of the recipient cornea, and then performing a full-thickness drilling to create a recess 1621.

[0282]

[0308] In step 1604, devices 100-140 are implanted and secured in place, as shown in FIG. 16C.

[0283]

[0309] In step 1606, as shown in Figures 16D-16E, a central opening 1623 is made in an anterior corneal lamella 1622 (which may be a previously removed recipient anterior corneal lamella or a donor anterior corneal lamella). The anterior corneal lamella 1622 is then sutured (1627) to cover the implantable device 100-140 such that the anterior end of the device 100-140 extends through the opening 1623.

[0284]

[0310] In step 1608, as shown in Figure 16F, a thin conjunctival flap layer 1624 may be placed over the anterior surface of the cornea 1622. A central opening 1628 is then formed in the thin conjunctival flap layer 1622 corresponding to the leading end of the optical stem of the device 100-140 such that the leading end of the optical stem is either directly below the anterior surface of the eye, substantially at the same level as the anterior surface of the eye, flush with the anterior surface of the eye, or slightly protrudes beyond the anterior surface of the eye.

[0285]

[0311] In step 1610, optional external elements including, for example, an end plate 1610 and an external optical lens 1616 may be attached to the front end of the device 100-140, as shown in FIG. 16G.

[0286]

[0312] 17A-17J show functional steps in an exemplary process 1700 for surgical implantation of devices 100-140 of the present disclosure, which may be any one of exemplary devices 100 (described with reference to FIGS. 1A-1C, 3D-3E, and 6), 110 (described with reference to FIGS. 9A-9D), 120 (described with reference to FIGS. 10A-10C), 130 (described with reference to FIGS. 11A-11D), and / or 140 (described with reference to FIGS. 12A-12C).

[0287]

[0313] The particular sequence of steps depicted with respect to process 1700 is not intended to be limiting. Other sequences of steps may be performed in accordance with alternative embodiments without departing from the techniques of the present disclosure. For example, alternative embodiments of the present invention may perform the steps outlined above in a different order or in parallel. Furthermore, individual steps may include multiple sub-steps that may be performed in various orders as desired. Furthermore, additional steps may be added or removed depending on the particular application.

[0288]

[0314] Continuing with reference to FIG. 17A, and as shown in FIGS. 17B-17C, process 1700 begins at step 1702 with preparation of a recipient cornea 1720.

[0289]

[0315] As shown in FIG. 17C, deep lamellar dissection (e.g., pneumatic, hydro-assisted, viscoelastic-assisted, and / or manual dissection) is performed in donor cornea 1720 to form an air bubble 1728 that separates the posterior stroma from a very thin layer 1729 of substantially optically transparent corneal tissue having a thickness of about 10-50 μm. In some embodiments, thin layer 1729 includes at least the pre-Descemet's layer. In some embodiments, thin layer 1729 includes the pre-Descemet's layer in addition to Descemet's membrane. In some embodiments, thin layer 1729 includes the pre-Descemet's layer, Descemet's membrane, and endothelium.

[0290]

[0316] In step 1704, as shown in FIG. 17D, a partial thickness drilling and anterior keratectomy is then performed in the stromal layer of the donor cornea 1720, removing the anterior corneal lamella 1722 while leaving the posterior stromal layer 1726.

[0291]

[0317] In step 1706, as shown in FIG. 17E, removal of deep posterior stroma in or around the area above the air bubble 1728 is performed in the posterior stroma 1726 to create a recess 1731 while leaving behind a thin posterior layer 1729 having a thickness of about 10-50 μm that is substantially optically transparent. In some embodiments, the very thin layer includes at least the pre-Descemet's layer. In some embodiments, the very thin layer includes the pre-Descemet's layer in addition to the Descemet's membrane. In some embodiments, the very thin layer includes the pre-Descemet's layer, Descemet's membrane, and the endothelium.

[0292]

[0318] In step 1708, the devices 100-140 are recessed and fixed 1725 in place such that the light projecting rear ports of the optical stems of the devices 100-140 are positioned through the recesses 1731, as shown in FIG. 17F.

[0293]

[0319] In step 1710, a central opening 1733 is made in the anterior corneal lamella 1722 (e.g., a previously removed recipient anterior corneal lamella or a donor anterior corneal lamella), as shown in Figures 17G-17H. The anterior corneal lamella 1722 is then sutured 1727 to cover the implanted devices 100-140, with the anterior ends of the devices 100-140 extending through the opening 1733.

[0294]

[0320] In step 1712, a thin conjunctival flap layer 1724 may be placed over the anterior surface of the cornea 1720, as shown in Figure 17I. A central opening 1734 is then formed in the thin conjunctival flap layer 1724 to accommodate the leading end of the optical stem of the device 100-140 such that the leading end of the optical stem is either directly below the anterior surface of the eye, substantially at the same level as the anterior surface of the eye, flush with the anterior surface of the eye, or slightly protrudes beyond the anterior surface of the eye.

[0295]

[0321] In step 1714, optional external elements including, for example, an end plate 1710 and an external optical lens 1716 may be attached to the front end of the device 100-140, as shown in FIG. 17J.

[0296]

[0322] FIG. 18A is a schematic diagram of an exemplary system for intracorneal projection of an image onto the retina, according to some embodiments of the present disclosure.

[0297]

[0323] In some embodiments, the system of the present disclosure comprises an extraocular image capture unit 1800 configured to capture one or more static or dynamic visual images (video).

[0298]

[0324] The extraocular image capture unit 1800 described herein is merely an exemplary embodiment of the invention, and may in fact be implemented with any combination of both hardware and software components. The extraocular unit 1800 may have more or fewer components and modules than shown, may combine two or more of the components, or may have a different configuration or arrangement of components. The extraocular unit 1800 may include any additional components that enable it to function as an operational computer system, such as a motherboard, data bus, power supply, network interface card, display, input devices (e.g., keyboard, pointing device, touch-sensitive display), etc. (not shown).

[0299]

[0325] In some embodiments, the extraocular unit 1800 may include an image processing module 1810 including one or more hardware processors 1810a and a memory storage device 1810b including, for example, random access memory (RAM) and one or more non-transitory computer-readable storage devices.

[0300]

[0326] The storage device 1810b may store program instructions and / or components configured to operate the hardware processor 1810a of the image processing module 1810. The program instructions may include one or more software modules, such as one or more image processing algorithms. The software components may include an operating system with various software components and / or drivers for controlling and managing general system tasks (e.g., memory management, storage device control, power management, etc.) and facilitating communication between various hardware and software components.

[0301]

[0327] In some embodiments, the extraocular unit 1800 comprises an imaging device 1804, which may be any suitable digital imaging device configured to capture still or video images of scenes, objects, and / or any other optically represented information, such as by text, symbols, or colors. In some embodiments, the image processing module 1810 is configured to implement any suitable one or more image processing algorithms and has an image signal generator for generating digital data signals that may represent visual images captured by the imaging device 1804. In some embodiments, the storage device 1810b may comprise an electrical circuit data memory of a type suitable for storing electrical digital image data signals.

[0302]

[0328] In some embodiments, the extraocular unit 1800 may include a wireless transmitter or transceiver 1806 configured to transmit image data signals using a non-optical data transmission modality, e.g., any suitable short-range RF transmission protocol, digital or analog, such as Bluetooth, ZigBee, etc.

[0303]

[0329] In some embodiments, the extraocular unit 1800 may include a power source 1808, which may include, for example, a rechargeable battery pack including one or more cells of a type commonly used to provide portable battery supplies, and a mechanism for short-range wireless power transmission. In some embodiments, the battery pack may provide power to a primary inductive coil 1808a. The primary inductive coil 1808a may transmit power wirelessly (1816), for example, via skin, bone, ocular tissue, etc., to a secondary receiving inductive coil in the intracorneal implant, as described further below.

[0304]

[0330] In some embodiments, both the functions of wireless data transmission and wireless power transmission may be performed by the primary inductive coil 1808a, which may be configured to cooperatively transmit power and data.

[0305]

[0331] In some embodiments, the extraocular unit 1800 may be in wireless data communication (1814) and wireless power communication (1816) with an exemplary intracorneal implant 1820 configured to be surgically implanted within the cornea of ​​the eye.

[0306]

[0332] In some embodiments, the intraocular implant 1820 may be sized and configured to traverse or completely replace the opaque tissue layer of the cornea and be surgically implanted within the eye, with only substantially transparent corneal tissue remaining behind the device.

[0307]

[0333] In some embodiments, the exemplary intracorneal implant 1820 may be sized and configured to be surgically implanted within the cornea of ​​the eye such that a layer of partially transparent, partially translucent, and / or partially opaque corneal tissue resides posterior to the light-projecting rear port of the device.

[0308]

[0334] As described in further detail below, the intracorneal implant 1820 is sized to fit within the cornea. In some embodiments, the intracorneal implant 1820 has a convex surface that substantially matches the convex surface of the cornea and defines a surface having opposing convex anterior surface (facing the anterior surface of the eye) and concave posterior surface (facing the retina of the eye).

[0309]

[0335] In some embodiments, the intracorneal implant 1820 comprises an inner platform portion 1824 positioned about the implant's axis of circular symmetry, and a peripheral portion comprising one or more angularly spaced arms 1826 extending laterally from the periphery of the inner platform 1824. In some embodiments, the intracorneal implant 1820 further comprises a peripheral skirt portion 1828 that defines a circular periphery of the intracorneal implant 1820, with the one or more arms 1826 connecting between the inner platform 1824 and the peripheral skirt portion 1828.

[0310]

[0336] In some embodiments, the exemplary intracorneal implant 1820 is sized to fit within the cornea behind any opaque corneal tissue layers and to generate an image detectable by a healthy retina or healthy portions of the retina of the eye. For example, the intracorneal implant 1820 may have a total span between opposing edges of, for example, 6-12 mm (e.g., 9 mm), a total planar thickness of 0.02-1.50 mm, and a convex surface with a curvature of 32-47 diopters.

[0311]

[0337] In some embodiments, the exemplary intracorneal implant 1820 comprises one or more components mounted to the intracorneal implant 1820, including, for example, an image projection controller 1830 with a hardware processor and memory storage device, an image generator 1834 mounted to the inner platform portion 1824, a wireless receiver or transceiver 1836, a wireless receiving element 1838, and an optical assembly 1840.

[0312]

[0338] FIG. 18B is a schematic diagram of a second exemplary system for intracorneal projection of an image onto the retina, according to some embodiments of the present disclosure.

[0313]

[0339] In some embodiments, a second exemplary system of the present disclosure comprises an extraocular image capture unit 1801 configured to capture one or more static visual images or dynamic visual images (video).

[0314]

[0340] The extraocular image capture unit 1801 described herein is merely an exemplary embodiment of the invention, and in fact may be implemented with any combination of both hardware and software components. The extraocular unit 1801 may have more or fewer components and modules than shown, may combine two or more of the components, or may have a different configuration or arrangement of components. The extraocular unit 1801 may include any additional components that enable it to function as an operational computer system, such as a motherboard, data bus, power supply, network interface card, display, input devices (e.g., keyboard, pointing device, touch sensor display), etc. (not shown).

[0315]

[0341] In some embodiments, the extraocular unit 1801 may include an image processing module 1810 including one or more hardware processors 1810a and a memory storage device 1810b including, for example, random access memory (RAM) and one or more non-transitory computer-readable storage devices.

[0316]

[0342] The storage device 1810b may store program instructions and / or components configured to operate the hardware processor 1810a of the image processing module 1810. The program instructions may include one or more software modules, such as one or more image processing algorithms. The software components may include an operating system with various software components and / or drivers for controlling and managing general system tasks (e.g., memory management, storage device control, power management, etc.) and facilitating communication between various hardware and software components.

[0317]

[0343] In some embodiments, the extraocular unit 1801 comprises an imaging device 1804, which may be any suitable digital imaging device configured to capture still or video images of scenes, objects, and / or any other optically represented information, such as by text, symbols, or colors. In some embodiments, the image processing module 1810 is configured to implement any suitable one or more image processing algorithms and has an image signal generator for generating digital data signals that may represent visual images captured by the imaging device 1804. In some embodiments, the storage device 1810b may comprise an electrical circuit data memory of a type suitable for storing electrical digital image data signals.

[0318]

[0344] In some embodiments, the extraocular unit 1801 may comprise a wireless transmitter or transceiver 1806 configured to transmit image data signals using a non-optical data transmission modality, e.g., any suitable short-range RF transmission protocol, digital or analog, such as Bluetooth, ZigBee, etc.

[0319]

[0345] In some embodiments, the extraocular unit 1801 may include a power source 1808, which may include, for example, a rechargeable battery pack including a type of battery commonly used to provide portable battery supplies, and a mechanism for short-range wireless power transmission. In some embodiments, the battery pack may provide power to a primary inductive coil 1808a. The primary inductive coil 1808a may transmit power wirelessly (1816), for example, via skin, bone, ocular tissue, etc., to a secondary receiving inductive coil in the intracorneal implant, as described further below.

[0320]

[0346] In some embodiments, both the functions of wireless data transmission and wireless power transmission may be performed by the primary inductive coil 1808a, which may be configured to cooperatively transmit power and data.

[0321]

[0347] In some embodiments, the extraocular unit 1801 may include an illumination source 1813 for illuminating a liquid crystal display (LCD) mounted on an intracorneal implant. In some embodiments, the illumination source 1813 may include any suitable illumination source, for example, one or more light emitting diodes (LEDs), such as white light emitting LEDs, colored LEDs, or high brightness power LEDs. In some embodiments, the illumination source 1813 may be configured to emit illumination sufficient to traverse a disturbed or opaque corneal layer that is at least partially opaque to visible light and reach an intracorneal implant 1821 implanted within the cornea of ​​the eye.

[0322]

[0348] The extraocular unit 1801 may be in wireless data communication (1814) and wireless power communication (1816), as well as illumination communication (1818), with an intracorneal implant 1821 configured to be surgically implanted within the cornea of ​​the eye.

[0323]

[0349] In some embodiments, the exemplary intracorneal implant 1821 may be sized and configured to be surgically implanted within the cornea of ​​the eye at a location posterior to the opaque tissue layer of the cornea, with either clear corneal tissue or no corneal tissue present behind the image generator of the device.

[0324]

[0350] As described in more detail below, the intracorneal implant 1821 is sized to fit within the cornea. In some embodiments, the intracorneal implant 1821 has a convex surface that substantially matches the convex surface of the cornea and defines a surface having opposing convex anterior surface (facing the anterior surface of the eye) and concave posterior surface (facing the retina of the eye).

[0325]

[0351] In some embodiments, the intracorneal implant 1821 comprises an inner platform portion 1824 positioned about the implant's axis of circular symmetry, and a peripheral portion comprising one or more angularly spaced arms 1826 extending laterally from the periphery of the inner platform 1824. In some embodiments, the intracorneal implant 1821 further comprises a peripheral skirt portion 1828 that defines a circular periphery of the intracorneal implant 1821, with the one or more arms 1826 connecting between the inner platform 1824 and the peripheral skirt portion 1828.

[0326]

[0352] In some embodiments, the exemplary intracorneal implant 1821 is sized to traverse or completely replace the opaque tissue layer of the cornea and fit within the cornea, with only substantially transparent corneal tissue behind the device.

[0327]

[0353] In some embodiments, the exemplary intracorneal implant 1821 is sized to fit within the cornea such that a layer of partially transparent, partially translucent, and / or partially opaque corneal tissue is posterior to the light-projecting rear port of the device.

[0328]

[0354] For example, the intracorneal implant 1821 may have a total span between opposing edges of, for example, 6-12 mm (eg, 9 mm), a total planar thickness of 0.020-1.5 mm, and a convex surface with a curvature of 32-47 diopters.

[0329]

[0355] In some embodiments, the intracorneal implant 1821 comprises one or more components mounted to the intracorneal implant 1821, including, for example, an image projection controller 1830, a memory storage device 1832, an LCD panel 1835 mounted to the inner platform portion 1824, a wireless receiver or transceiver 1836, a wireless receiving element 1838, and an optical assembly 1840.

[0330]

[0356] In some embodiments, the LCD panel 1835 does not include a backlight or similar illumination source integrated within the intracorneal implant 1821. By way of explanation, an LCD panel display comprises a matrix of pixels that can be controllably dimmed or made transparent to present any pattern or image. LCD panels typically do not emit light directly, but rather rely on the use of an integrated backlight to generate images. While the power requirements of the LCD panel itself are minimal, the power requirements of the backlight are significantly higher. Thus, in the context of an LCD panel mounted in a device implanted within the cornea, it is advantageous to eliminate the need to integrate a backlight within the implanted device and rely instead on an external illumination source. This may lead to a significant reduction in the power consumption, physical footprint, and complexity of the implanted device. Thus, in some embodiments, the LCD panel 1835 is configured to be illuminated by the external illumination source 1813 of the extraocular unit 1800.

[0331]

[0357] FIG. 18C is a schematic diagram of a third exemplary system for intracorneal projection of an image onto the retina, according to some embodiments of the present disclosure.

[0332]

[0358] The extraocular image capture unit 1802 described herein is merely an exemplary embodiment of the invention, and in fact may be implemented with any combination of both hardware and software components. The extraocular unit 1802 may have more or fewer components and modules than shown, may combine two or more of the components, or may have a different configuration or arrangement of components. The extraocular unit 1802 may include any additional components that enable it to function as an operational computer system, such as a motherboard, data bus, power supply, network interface card, display, input devices (e.g., keyboard, pointing device, touch sensor display), etc. (not shown).

[0333]

[0359] In some embodiments, the extraocular unit 1802 may include an image processing module 1810 including one or more hardware processors 1810a and a memory storage device 1810b including, for example, random access memory (RAM) and one or more non-transitory computer-readable storage devices.

[0334]

[0360] The storage device 1810b may store program instructions and / or components configured to operate the hardware processor 1810a of the image processing module 1810. The program instructions may include one or more software modules, such as one or more image processing algorithms. The software components may include an operating system with various software components and / or drivers for controlling and managing general system tasks (e.g., memory management, storage device control, power management, etc.) and facilitating communication between various hardware and software components.

[0335]

[0361] In some embodiments, the extraocular unit 1802 comprises an imaging device 1804, which may be any suitable digital imaging device configured to capture still or video images of scenes, objects, and / or any other optically represented information, such as by text, symbols, or colors. In some embodiments, the image processing module 1810 is configured to implement any suitable one or more image processing algorithms and has an image signal generator for generating digital data signals that may represent visual images captured by the imaging device 1804. In some embodiments, the storage device 1810b may comprise an electrical circuit data memory of a type suitable for storing electrical digital image data signals.

[0336]

[0362] In some embodiments, the extraocular unit 1802 may include a power source 1808, which may include, for example, a rechargeable battery pack including batteries of a type commonly used to provide portable battery supplies, and a mechanism for short-range wireless power transmission.

[0337]

[0363] In some embodiments, the extraocular unit 1802 may include an illumination source 1813 for illuminating a liquid crystal display (LCD) mounted on an intracorneal implant. In some embodiments, the illumination source 1813 may include any suitable illumination source, for example, one or more light emitting diodes (LEDs), such as white light emitting LEDs, colored LEDs, or high brightness power LEDs. In some embodiments, the illumination source 1813 may be configured to emit illumination sufficient to traverse a disturbed or opaque corneal layer that is at least partially opaque to visible light and reach an intracorneal implant 1822 implanted within the cornea of ​​the eye.

[0338]

[0364] In some embodiments, the extraocular unit 1802 may comprise a light beam source 1815 configured to transmit a light beam including a power signal and / or a data signal encoding information. In some embodiments, the light beam source 1815 may include a visible or invisible light source (e.g., an infrared light source). In some embodiments, the light beam source 1815 may be selected from the group consisting of LEDs, laser diodes, and the like. In some embodiments, the light beam source 1815 may be configured to perform the functions of wireless data transmission and wireless power transmission.

[0339]

[0365] Thus, the extraocular unit 1802 may be in illumination communication (1818), and wireless data and power communication (1819), with an intracorneal implant 1822 configured to be surgically implanted within the cornea of ​​the eye.

[0340]

[0366] In some embodiments, the exemplary intracorneal implant 1822 may be sized and configured to traverse or completely replace the opaque tissue layer of the cornea and be surgically implanted within the cornea of ​​the eye, with only substantially transparent corneal tissue remaining behind the device.

[0341]

[0367] In some embodiments, the exemplary intracorneal implant 1822 may be sized and configured to be surgically implanted within the cornea of ​​the eye such that a layer of partially transparent, partially translucent, and / or partially opaque corneal tissue resides posterior to the light projection rear port of the device.

[0342]

[0368] In some embodiments, the intracorneal implant 1822 has a convex surface that substantially matches the convex surface of the cornea and defines a surface having opposing convex anterior surfaces (facing the anterior surface of the eye) and concave posterior surfaces (facing the retina of the eye).

[0343]

[0369] In some embodiments, the intracorneal implant 1822 comprises an inner platform portion 1824 positioned about the implant's axis of circular symmetry, and a peripheral portion comprising one or more angularly spaced arms 1826 extending laterally from the periphery of the inner platform 1824. In some embodiments, the intracorneal implant 1822 further comprises a peripheral skirt portion 1828 that defines a circular periphery of the intracorneal implant 1822, with the one or more arms 1826 connecting between the inner platform 1824 and the peripheral skirt portion 1828.

[0344]

[0370] In some embodiments, the exemplary intracorneal implant 1822 is sized to fit within the cornea behind any opaque corneal tissue layers and generate an image detectable by a healthy retina or healthy portions of the retina of the eye. For example, the intracorneal implant 1822 may have a total span between opposing edges of, for example, 6-12 mm (e.g., 9 mm), a total planar thickness of 0.020-1.5 mm, and a convex surface with a curvature of 32-47 diopters.

[0345]

[0371] In some embodiments, the receiver 1837 comprises, for example, a photocell for receiving power and a photodiode for receiving data transmitted by the light beam source 1815 via wireless data and wireless power communication 1819.

[0346]

[0372] 18D illustrates an exemplary extraocular unit 1844 of the present disclosure, where the various components of the extraocular unit are mounted on glasses worn by a user, including, but not limited to, an imaging device 1804, a transmitter / transmitter / receiver 1806, a primary inductive coil 1808a, a power source 1808, an image processing module 1810, and / or an illumination source 1813. However, in other exemplary embodiments, the various components of the extraocular unit 1800 may be mounted on any one or more head-mounted elements, such as a helmet, a headband, headgear, etc. In some embodiments, the imaging device 1804 may be advantageously located close to the viewpoint of one or both eyes of the wearer.

[0347]

[0373] 18E illustrates an exemplary illumination source 1813 of the present disclosure, as described with reference to FIGS. 18B-18C, that may be mounted within the lens area of ​​eyeglasses (as shown in FIG. 18D) such that the illumination source 1813 is configured to illuminate an intracorneal implant 1820 embedded within the cornea of ​​the eye. Thus, the illumination source 1813 may be mounted within the lens area of ​​eyeglasses worn by a user such that the illumination source 1813 is aligned with the optical axis XX of the eye and may illuminate an LCD panel mounted on the intracorneal implant 1820 to project an image displayed by the LCD panel onto the retina of the eye (e.g., via an optical transmission path that may include the lens of the eye and / or one or more focusing optics of the present disclosure). In some embodiments, the primary inductive coil 1808a may be mounted, for example, in a peripheral area of ​​the illumination source 1813.

[0348]

[0374] 19A-19D show a front perspective view (19A), a rear view (19B), a front view (19C), and a side view (19D), respectively, of an exemplary intracorneal implant 1820, according to some embodiments of the present disclosure.

[0349]

[0375] In some embodiments, the intracorneal implant 1820 has a convex surface that substantially matches the convex surface of the cornea and defines a surface having opposing concave posterior surface (as shown in FIG. 19A, facing the retina of the eye) and convex anterior surface (as shown in FIG. 19B, facing the anterior surface of the eye).

[0350]

[0376] In some embodiments, the intracorneal implant 1820 comprises an inner platform portion 1824 positioned about an axis of circular symmetry of the implant, and a periphery comprising one or more angularly spaced arms 1826 extending laterally from a periphery of the inner platform 1824. In some embodiments, the inner platform portion 1824 comprises at least one, two, three, four, five, or more arms 1826.

[0351]

[0377] In some embodiments, the intracorneal implant 1820 further comprises a peripheral skirt 1828 that defines a circular periphery of the intracorneal implant 1820 , with one or more arms 1826 connecting between the inner platform 1824 and the peripheral skirt 1828 .

[0352]

[0378] In some embodiments, the intracorneal implant 1820 may be sized and configured to traverse or completely replace the opaque tissue layer of the cornea and be surgically implanted within the cornea of ​​the eye, with only substantially transparent corneal tissue remaining behind the device.

[0353]

[0379] In some embodiments, the intracorneal implant 1820 is sized and configured to be surgically implanted within the cornea of ​​the eye such that a layer of partially transparent, partially translucent, and / or partially opaque corneal tissue resides posterior to the light-projecting rear port of the device.

[0354]

[0380] In some embodiments, the exemplary intracorneal implant 1820 is sized to fit within the cornea behind any opaque corneal tissue layers and to generate an image detectable by a healthy retina or healthy portions of the retina of the eye. For example, the intracorneal implant 1820 may have a total span between opposing edges of, for example, 6-12 mm (e.g., 9 mm), a total planar thickness of 0.02-1.50 mm, and a convex surface with a curvature of 32-47 diopters.

[0355]

[0381] In some embodiments, the intracorneal implant 1820 may be formed of any suitable biocompatible material, such as any metal, metal alloy (e.g., Nitinol, stainless steel, etc.), and / or polymer. In some embodiments, the intracorneal implant 1820 may be integrally formed as a unitary intracorneal implant of a single material, or may be assembled from two or more separate components, where each component may be made of a different material. In some embodiments, the intracorneal implant 1820, or any portion thereof, may be made of a hard or non-deformable material, a shape memory material, and / or a flexible or deformable material. In some embodiments, the intracorneal implant 1820, or any portion thereof, may have a coating, such as, for example, an epoxy material.

[0356]

[0382] In some embodiments, the intracorneal implant 1820 is shaped to define one or more openings, for example, defined by a space between the peripheral skirt portion 1828, the inner platform portion 1824, and the one or more arms 1826. In some embodiments, the one or more openings are configured to allow for the application of the intracorneal implant 1820 within the cornea through the openings and fixation of the intracorneal implant 1820 within the surrounding corneal tissue. In this manner, once the intracorneal implant 1820 is implanted and the eye heals, the intracorneal implant 1820 is substantially fixed in place by the growth and remodeling of the surrounding tissue. In some embodiments, the one or more openings define a total opening surface area, for example, 30-50% of the total surface area of ​​the intracorneal implant 1820.

[0357]

[0383] In some embodiments, the image generator 1834 may be sized and configured to be coupled to the inner platform portion 1824 via the light projection rear port 1834a to display and / or project an image posteriorly relative to the surface of the eye toward and onto the retina of the eye (e.g., via an optical transmission path that may include a lens of the eye and / or one or more focusing optics of the present disclosure).

[0358]

[0384] In some embodiments, the image projection controller 1830 receives input image data received by the wireless receiver module 1836 and optionally stores the image data in a memory storage module. The image projection controller 1830 processes the digital image data encoded in the signal to generate and reconstruct a visual image therefrom and operates the image generator 1834 to generate a light beam based on the image data and project the generated light beam onto the retina. In some embodiments, the image projection controller 1830 may be implemented as one or more circuit modules coupled to any portion of the intracorneal implant 1820, such as one or more rear surfaces of the arms 1826, as shown in FIGS. 19A and 19B.

[0359]

[0385] In some embodiments, the image generator 1834 is configured and operable to receive image data signals from an extraocular source and generate an image projection light beam (e.g., a light beam modulated with visual image information) that is projected through the light projecting rear port 1834a onto the retina of the eye to generate an image. In some embodiments, the image generator 1834 is configured to output an image projection light beam that can pass through transparent, semi-transparent, and / or substantially opaque corneal tissue present behind the light projecting rear port of the device and reach the retina of the eye.

[0360]

[0386] In some embodiments, the image generator 1834 comprises a display element connected to the image projection controller 1830. The image generator 1834 can generate and project an image projection light beam onto the retina of the eye. In some embodiments, the image generator 1834 can comprise, for example, a color or monochrome liquid crystal display (LCD) and a backlight source.

[0361]

[0387] In other embodiments, the image generator 1834 comprises a micro-optical array mounted on a flexible printed circuit board ("PCB") that supports electronic and optical components. The micro-display may comprise small pixels, each having a size, for example, in the range of 2 microns to 100 microns. The micro-display may be coupled to and supported by the inner platform portion 1824 of the intracorneal implant 1820. In some embodiments, the micro-display may be monochromatic or multi-chromatic. In some embodiments, the micro-display forms an array of pixels characterized by a pixel size and a pixel pitch. As described herein, the pixel size may range, for example, from 2 microns to 100 microns, and the pixel pitch may range from 10 microns to 1.0 mm.

[0362]

[0388] In some embodiments, the image generator 1834 may be configured to receive illumination from an extraocular unit of the present disclosure, such as the exemplary extraocular units 1801 of Figure 18B and 1802 of Figure 18C. In such embodiments, the extraocular unit may be configured to provide an illumination source to an LCD panel of the image generator 1834.

[0363]

[0389] The optical assembly 1840 may be mounted behind and optically coupled to the image generator 1834 to focus or apply other suitable or desired optical manipulation to the image projection light beam generated and projected by the image generator 1834. The optical assembly 1840 may include, for example, an adjustable imaging lens that focuses the image transmitted through the cornea onto the retina at the back of the eye, which may function like the lens of a normal healthy eye.

[0364]

[0390] In some embodiments, the wireless receiver or transceiver 1836 may be implemented as an electrical circuit coupled to any portion of the intracorneal implant 1820, such as one or more rear surfaces of the arms 1826, as shown in Figures 19A and 19B. The wireless receiver or transceiver 1836 may be configured in wireless data communication with the wireless transmitter or transceiver 1806 of the extraocular unit 1800 to receive image data signals transmitted by the transmitter or transceiver 1806 using a non-optical data transmission modality, e.g., any suitable short-range RF transmission protocol, such as Bluetooth, ZigBee, etc.

[0365]

[0391] In some embodiments, the receiving element 1838 may be implemented as a secondary receiving inductive coil mounted on the intracorneal implant 1820, for example disposed around the posterior surface of the peripheral skirt 1828, and / or any other suitable location. In some embodiments, the receiving element 1838 comprises an inductive coil made from a winding. Alternatively, the secondary receiving inductive coil may be made from a thin film polymer sandwich with wire traces deposited between layers of thin film polymer.

[0366]

[0392] In some embodiments, the functions of wireless data reception and wireless power reception may both be performed by the wireless receiving element 1838, and the secondary receiving inductive coil 1838 may be configured to cooperatively receive power and data.

[0367]

[0393] 20 is a schematic diagram of an exemplary intracorneal implant 1820 with multiple haptics 1842. In some embodiments, the intracorneal implant 1820 of the present disclosure may further comprise one or more haptics 1842 extending laterally from the periphery of the implant. The haptics may function structurally to center the intracorneal implant within a pocket formed in the cornea during surgery.

[0368]

[0394] The haptics 1842 extend outwardly from and are spaced apart from the peripheral skirt 1828 of the intracorneal implant 1820. Each of the haptics 1842 includes a proximal end that connects to the outer periphery of the peripheral skirt 1828 and a projecting segment that terminates at a distal end.

[0369]

[0395] In some embodiments, between two and six haptics 1842 may be used. In some embodiments, the haptics 1842 may be split into opposing pairs, each extending outwardly away from the peripheral skirt portion 1828 at opposite ends of the peripheral skirt portion 1828.

[0370]

[0396] During implantation of the intracorneal implant 1820, each of the haptics 1842 may be manipulated to move the center of the intracorneal implant 1820 as close as possible to the optical axis of the eye and to ensure that the intracorneal implant 1820 has the desired rotational alignment in the XY plane and is fixed in place within the cornea.

[0371]

[0397] 21A through 21D show steps in a process for surgically implanting an intracorneal implant 1820 within a cornea 2100. FIG.

[0372]

[0398] In some embodiments, the intracorneal implants of the present disclosure may be configured to be surgically implanted within the cornea using any suitable surgical method, for example, by: -Creating a partial anterior corneal stromal flap or lamella, making a deep lamellar incision to create a recess, and placing the implant in the recess beneath the flap or lamella. - Creating a partial anterior corneal stromal flap or lamella, forming a hollow pocket in the cornea, placing an implant in the pocket and securing the implant with the corneal flap or lamella. - Creating a partial anterior corneal stromal flap or lamella, forming a hollow pocket in the cornea, placing an implant that is pre-assembled pre-operatively or assembled intra-operatively within the corneal tissue scaffold, and securing the implant with the corneal flap or lamella. The corneal tissue scaffold may be the exemplary corneal tissue scaffold 1329 described with reference to Figures 13A-13F. - A conjunctival flap procedure or mucosal graft to permanently cover the cornea may also be performed simultaneously or sequentially after the surgical implantation.

[0373]

[0399] 21A shows the human eye, including the cornea 2100, iris 2102, lens 2104, vitreous region 2106, retina 2108, and optic nerve 2110.

[0374]

[0400] 21B illustrates a pocket 2120 formed in the cornea 2100 configured to receive an intracorneal implant 1820 of the present disclosure. In some embodiments, the pocket 2120 may be formed using any suitable surgical method, such as by creating a partial anterior corneal stromal flap or lamella, making a deep lamellar incision to create the pocket 2120, and placing the intracorneal implant 1820 in the pocket 2120 under the flap or lamella. In other embodiments, the pocket 2120 may be formed by creating a partial anterior corneal stromal flap or lamella, forming a hollow pocket in the cornea, placing the intracorneal implant 1820 in the pocket, and securing the intracorneal implant 1820 with the corneal flap or lamella.

[0375]

[0401] FIG. 21C shows an intracorneal implant 1820 implanted within a pocket 2120 in the cornea 2100.

[0376]

[0402] 21D shows a corneal lamella 2122 placed and sutured over the pocket 2120 to complete the implantation process. In some embodiments, a conjunctival flap surgery or mucosal graft to permanently cover the cornea may also be performed simultaneously or sequentially after surgical implantation of the intracorneal implant 1820 into the pocket 2120.

[0377]

[0403] FIG. 21E details an optional optical assembly 1840 that is implanted in the eye. The optical assembly 1840 may be mounted behind and optically coupled to the intracorneal implant 1820 to focus a projected image on the retina. The optical assembly 1840 may comprise any suitable one or more optical lenses or other optical elements. In some embodiments, the optical assembly 1840 may be configured to focus a projected optical image on the retina, for example, in conjunction with or in the absence of the eye's natural lens 2104. In some embodiments, the optical assembly 1840 may comprise an adjustable imaging lens that may function like the lens of a normal healthy eye to focus an image transmitted through the cornea on the retina at the back of the eye.

[0378]

[0404] 22 illustrates a cross-sectional view of an eye having an intracorneal implant 1820 implanted within a cornea 2100. As can be seen, an image generator 1834 is configured to project an image onto a retina 2108 (e.g., via an optical transmission path that may include the lens of the eye and / or one or more optical assemblies of the present disclosure).

[0379]

[0405] The description of various embodiments of the present invention is presented for illustrative purposes and is not intended to be exhaustive or to be limited to the explicit description. Many modifications and variations will be apparent to those skilled in the art without departing from the scope and spirit of the described embodiments. The terms used in this specification have been selected to best explain the principles of the embodiments, practical applications or technical improvements of the technology found in the market, or to enable other skilled in the art to understand the embodiments disclosed herein.

[0380]

[0406] In this specification and claims, the terms "substantially," "essentially," and forms thereof, when referring to a numerical value, refer to a deviation from the numerical value by up to 20% (i.e., ±20%). Similarly, when such terms refer to a range of numerical values, they refer to a range up to 20% broader, 10% above and 10% below the stated range.

[0381]

[0407] Any numerical range herein is considered to have specifically disclosed all possible subranges and individual numerical values ​​within that range, and such subranges and individual numerical values ​​constitute certain embodiments of the invention. This applies regardless of the breadth of the range. For example, recitation of an integer range from 1 to 6 should be considered to have specifically disclosed subranges such as 1 to 3, 1 to 4, 1 to 5, 2 to 4, 2 to 6, 3 to 6, etc., as well as individual numbers within that range, such as 1, 4, 6. Similarly, recitation of a fractional range, such as 0.6 to 1.1, should be considered to have specifically disclosed subranges such as 0.6 to 0.9, 0.7 to 1.1, 0.9 to 1, 0.8 to 0.9, 0.6 to 1.1, 1 to 1.1, etc., as well as individual numerical values ​​within that range, such as 0.7, 1, 1.1.

[0382]

[0408] The description of various embodiments of the present invention is presented for illustrative purposes and is not intended to be exhaustive or to be limited to the explicit description. Many modifications and variations will be apparent to those skilled in the art without departing from the scope and spirit of the described embodiments. The terms used in this specification have been selected to best explain the principles of the embodiments, practical applications or technical improvements of the technology found in the market, or to enable other skilled in the art to understand the embodiments disclosed herein.

[0383]

[0409] In the present specification and claims, the words "comprise", "include", and "have" and their forms do not necessarily limit the members of a list with which the word may be associated.

[0384]

[0410] In the event of a conflict between the present specification and a document incorporated by reference or otherwise relied upon, the present specification is intended to control.

Claims

1. a central portion defining a recess having a posterior end including a thin layer of corneal tissue, the thin layer of corneal tissue including at least the anterior Descemet's layer and Descemet's membrane, or at least the anterior Descemet's layer; a peripheral portion of corneal tissue surrounding the recess, the peripheral portion including one or more of a posterior layer of the corneal stroma, the anterior layer of Descemet's membrane, and an endothelial layer; An implantable corneal tissue scaffold device comprising: the implantable corneal tissue scaffold comprising: (i) performing a deep lamellar incision in the cornea separating the deep posterior stroma of the cornea from the pre-Descemet's layer or the pre-Descemet's layer and the Descemet's membrane; (ii) performing partial perforation and removal of the anterior layer of the stroma of the cornea in the cornea; (iii) removing a central portion of the deep posterior stroma of the cornea to create the recess; and (iv) performing a full-thickness drilling to remove the entire implantable corneal tissue scaffold device, including the central and peripheral portions, from the cornea.

2. 10. The implantable corneal tissue scaffold device of claim 1, wherein the corneal tissue scaffold device has a diameter of 5 to 11 mm.

3. 3. The implantable corneal tissue scaffold device of claim 1 or 2, wherein the thin layer of corneal tissue has a thickness of 10 μm to 50 μm and the peripheral portion has a thickness of 100 μm to 500 μm.

4. 10. The implantable corneal tissue scaffold device of claim 1, wherein the thin layer of corneal tissue is substantially transparent.

5. 10. The implantable corneal tissue scaffold device of claim 1, wherein the cornea is a donor cornea.

6. The implantable corneal tissue scaffold device of claim 1 , wherein the recess has a diameter of 3 mm to 7 mm.

7. 10. The implantable corneal tissue scaffold device of claim 1, wherein the deep lamellar dissection is performed using one or more of pneumatic dissection, hydro-assisted dissection, viscoelastic-assisted dissection, and manual dissection.

8. 10. The implantable corneal tissue scaffold device of claim 1, wherein the removed anterior layer of the stroma of the cornea has a thickness of 100 to 400 μm.

9. 10. The implantable corneal tissue scaffold device of claim 1, wherein the corneal tissue scaffold device is configured to be implanted in the eye within a through recess formed in the eye by full-thickness drilling.

10. 10. The implantable corneal tissue scaffold device of claim 1, wherein the corneal tissue scaffold device is pretreated using at least one of dehydration, freeze-drying, plasticization, gelation, dehydrothermal treatment, mechanical treatment, compression, decontamination, and sterilization.

11. an implantable corneal tissue scaffold comprising: a central portion defining a recess having a posterior end including a thin layer of corneal tissue, the thin layer of corneal tissue including at least a pre-Descemet's layer and a Descemet's membrane, or at least the pre-Descemet's layer; and a peripheral portion of corneal tissue surrounding the recess, the peripheral portion including one or more of a posterior layer of corneal stroma, the pre-Descemet's layer, the Descemet's membrane, and an endothelial layer; (i) performing a deep lamellar incision in the cornea separating the deep posterior stroma of the cornea from the pre-Descemet's layer or the pre-Descemet's layer and the Descemet's membrane; (ii) performing partial perforation and removal of the anterior layer of the stroma of the cornea in the cornea; (iii) removing a central portion of the deep posterior stroma of the cornea to create the recess; and (iv) performing a full-thickness drilling to remove the entire implantable corneal tissue scaffold device, including the central portion and the peripheral portion, from the cornea. The method of claim 1, wherein the compound is a hydroxybenzoate.

12. The method of claim 11 , wherein the corneal tissue scaffold device has a diameter of 5 to 11 mm.

13. 13. The method of claim 11 or 12, wherein the thin layer of corneal tissue has a thickness of 10 to 50 μm and the peripheral portion has a thickness of 100 to 500 μm.

14. The method of claim 11 , wherein the thin layer of corneal tissue is substantially transparent.

15. The method of claim 11 , wherein the cornea is a donor cornea.

16. The method of claim 11 , wherein the recess has a diameter of 3 mm to 7 mm.

17. 12. The method of claim 11, wherein the deep laminar dissection is performed using one or more of pneumatic dissection, hydraulically assisted dissection, viscoelastically assisted dissection, and manual dissection.

18. 12. The method of claim 11, wherein the removed anterior layer of the stroma of the cornea has a thickness of 100 to 400 μm.

19. 12. The method of claim 11, further comprising: configuring the corneal tissue scaffold device to be implanted within the eye within a through recess formed in the eye by full-thickness drilling.

20. 12. The method of claim 11, further comprising pretreating the corneal tissue scaffold device with at least one of dehydration, lyophilization, plasticization, gelation, dehydrothermal treatment, mechanical treatment, compression, decontamination, and sterilization.

21. an implantable corneal tissue scaffold comprising: a central portion defining a recess having a posterior end including a thin layer of corneal tissue, the thin layer of corneal tissue including at least a pre-Descemet's layer and a Descemet's membrane, or at least the pre-Descemet's layer; and a peripheral portion of corneal tissue surrounding the recess, the peripheral portion including one or more of a posterior layer of corneal stroma, the pre-Descemet's layer, the Descemet's membrane, and an endothelial layer; an intracorneal implant defining a planar body having a convex surface that substantially matches the convex surface of the cornea, (i) a central optic having an anterior end and an optic stem extending axially through the cornea to a posterior end; (ii) a peripheral haptic portion having two or more angularly spaced haptics extending laterally from the central optic portion; and an intracorneal implant comprising: The system wherein the intracorneal implant is attached to the implantable corneal tissue scaffold device such that the posterior end abuts or contacts and engages with the thin layer of corneal tissue.

22. 22. The system of claim 21, further comprising an anterior corneal lamella sutured in place over the intracorneal implant.

23. 23. The system of claim 22, wherein the system is intended for surgical implantation within an eye in a through-hole recess formed by a full-thickness corneal perforation.

Images