Photoceutical devices for treatment of retinal disease

Abstract

A phototherapeutic eye apparatus. A backplate is placed in contact with the sclera when the phototherapeutic eye apparatus is inserted in an eye through an incision. The apparatus includes a a light source for illuminating preferred regions of the retina. An armature is disposed between the backplate and the light source. A cross sectional dimension of the armature tapers down from a first cross sectional dimension nearest the light source to a second cross sectional dimension nearest the backplate. The taper maintains the armature within the incision and thus the phototherapeutic eye apparatus within the eye.

Description

[0001] 11432-018US1

[0002] PHOTOCEUTICAL DEVICES FOR TREATMENT OF RETINAL DISEASE

[0003] CROSS REFERENCE TO RELATED APPLICATIONS

[0004] The present invention claims priority under 35 USC 119(e) to the provisional patent application filed on April 17, 2025, and assigned application number 63 / 790,133. This provisional patent application is incorporated in its entirety herein.

[0005] FIELD OF INVENTION

[0006] This invention relates to the field of ophthalmology and medical devices for treatment of hypoxic retinal diseases using light (primarily derived from a tritium-based light source (TLS)) as a photoceutical device.

[0007] BACKGROUND OF THE INVENTION

[0008] Dark adaptation of rod cells has been hypothesized to drive retinal hypoxia due to elevated metabolic demand, notably during long periods of darkness such as while asleep. This can drive or exacerbate several retinal diseases and conditions including, diabetic retinopathy (DR), diabetic macular edema (DME), age-related macular degeneration (AMD), retinal vein occlusion (RVO), retinopathy of prematurity (ROP), and glaucoma.

[0009] Diabetes mellitus is one of the fastest-growing diseases afflicting the modern world. The increasing availability of low-quality food and a shift toward sedentary work environments drives this, as well as the subsequent onset of associated complications. One such complication is DR - a disease characterized by macular edema resulting from neovascularization of the retina. Neovascularization is, in turn, driven by retinal hypoxia. DR can eventually cause vision loss and blindness.

[0010] Reduced retinal oxygen uptake, known as retinal hypoxia, is the primary driver for the progression of diabetic retinopathy. The reduced oxygen uptake is due to the obliteration, shunting, and occlusion of capillaries in the diabetic retina.

[0011] Another factor reducing oxygen perfusion is glycosylated hemoglobin's (HbAlc) ten times higher affinity for oxygen retention when compared to non-glycosylated hemoglobin (HbAO). HbAlc levels range 1.5-2x higher in diabetic patients (9%) than in healthy patients(5%). Tn other words, diabetics' high blood sugar prevents their blood from delivering adequate amounts of oxygen to body systems.

[0012] Rod cell metabolism is inversely related to light level and is dominated by sodium (Na+) circulating in the outer rod segment. In the dark, Na+ circulates in and out of rod cells' open cGMP -gated Na+ channels, a phenomenon known as "dark current." When in this state, rod cells remain partially depolarized and burn copious amounts of energy to increase their sensitivity and enable perception of dimly lit scenes. As photons hit the rods, the phototransduction cascade leads to closure of cGMP-gated Na+ channels, hyperpolarizing the rods. When subjected to light, the rods provide enough data for the central nervous system (CNS) to process a functional image, precluding them from an increase in sensitivity that necessitates an increase in metabolism.

[0013] Retinal hypoxia is driven by dark current's exacerbation of oxygen consumption. For example, exposure to scotopic (i.e., dim or low intensity) light in rods decreases their oxygen consumption by about 3000 O2 molecules per photon. The resulting retinal hypoxia drives the expression of VEGF, the protein that promotes the growth of leaky blood vessels. The resulting neovascularization in the retina forms blood vessels that leak fluid and scar the surrounding tissue.

[0014] Retinal hypoxia triggers the vascular endothelial growth factor (VEGF) signaling pathway, promoting neovascularization in the retina. Resultant malformed blood vessels grow into the eye, leaking vision-obstructing fluid, a condition called macular edema.

[0015] Intravitreal anti-VEGF injections are a primary treatment modality for DR by blocking the VEGF pathways. These injections are designed to combat abnormal blood vessel growth, which is a hallmark of diabetic retinopathy, by blocking the action of VEGF. Thus, the anti-VEGF injections help prevent macular edema and subsequent blindness in DR patients. Anti-VEGF injections are also indicated for other retinal diseases including, neovascular AMD, DME, RVO, ROP, and glaucoma.

[0016] Although these injections significantly reduce neovascularization, they also present a host of negative side effects. High irritation and discomfort in the eye are the most common effects that tend to discourage many patients from adhering to their treatment regimen. Patients receiving anti-VEGF injections also have a 25-40% rate of developing glaucoma as the optic nerve is degraded over the treatment regimen, risking vision loss.Other risk factors, such as retinal detachment and blood clots, further detract from anti-VEGF injections' clinical appeal as a modality. From a financial perspective, anti-VEGF injections place a huge economic burden on those suffering from diabetic retinopathy. The injection is administered every 2-4 weeks at an outpatient or inpatient facility, bringing the average two-year cost for a US patient to about $30,328. When extrapolated to the approximate number of Americans suffering from DR (about 9.6 million people), this may cost the American healthcare system up to $135B annually.

[0017] The use of implantable phototherapy may help to reduce the use of anti-VEGF drugs by delaying disease onset, reducing the necessary frequency between drug administration, and / or reducing the size of a dose. Phototherapy could also have impact in combination with newer modalities of treatment, including gene therapy.

[0018] Over 150 million DR patients worldwide stand to benefit from an improved treatment modality, and countless others suffering from AMD, DME, RVO, ROP, and glaucoma. A phototherapeutic approach may be leveraged to reversibly modulate retinal metabolism and thereby reduce the occurrence of diabetic retinopathy and the resulting vision degradation. Additionally, light-adapting ocular phototherapy can improve outcomes of other hypoxia-driven ocular diseases such as glaucoma, sickle cell anemia, choroidal ischemia, and macular degeneration.

[0019] Panretinal laser photocoagulation is another technique for treating advanced diabetic retinopathy. During pan-retinal photocoagulation, a specialized laser creates a pattern of small burns or laser spots across the retina. These laser burns induce controlled tissue damage, which, paradoxically, helps reduce abnormal blood vessel growth by sealing leaking vessels and reducing oxygen demand in the retina. The resulting damage to retinal vasculature also, ironically, improves oxygen's perfusion from blood vessels into the retina. These effects drive pan-retinal photocoagulation's efficacy in lowering retinal hypoxia, thereby lessening VEGF expression and thereby, subsequent macular edema.

[0020] Panretinal photocoagulation, however, is not without side effects. The selective burning of retinal tissue permanently reduces the patient's vision acuity and contrast sensitivity. Because of this, pan-retinal photocoagulation is usually postponed until the patient is suffering from central vision problems. However, this treatment offers a suboptimal solution, settling for some permanent vision loss rather than complete vision loss.The longest period during which dark current exacerbates hypoxia is during sleep when the eyes are not receiving light. Therefore, it stands to reason that phototherapy should be administered during sleep to reduce hypoxia during this time.

[0021] Most famously, PolyPhotonix Medical Ltd (of Sedgefield, United Kingdom) has developed a light-emitting sleep mask that is currently undergoing commercialization in the United Kingdom. This mask uses an organic light-emitting diode (OLED) array to deliver light through the eyelids and pupils during sleep.

[0022] But Polyphotonix' s sleep mask, as a light source external to the eye, fails to effectively deliver light to the retina. This is due to various factors. The primary factor is an order-of-magnitude variability in human eyelid transmissivity across the human population. Designing the mask for a specific transmissivity or range of transmissivities precludes a portion of the patient population from using this device successfully. Another confounding variable is that during deep sleep, pupil diameter is about three times smaller than during dark-adapted awake conditions. Lastly, the eye's upward slant during sleep, known as Bell's phenomenon, increasingly shifts the pupil away from the OLED light as sleep deepens. Rapid eye movement (REM) also compromises the coincidence of incoming light and the pupil. All these factors contribute to the inefficacy of a phototherapeutic sleep mask.

[0023] Studies conducted by researchers at the California Institute of Technology have resulted in the development of various other approaches for light-adapting phototherapy to prevent neovascularization and the progressive worsening of DR.

[0024] One such non-invasive phototherapeutic approach comprises a gaseous tritium light source (GTLS) in a contact lens. Within a housing or chamber of the GTLS, decaying beta particles strike a luminophore that, in turn, provides illumination.

[0025] In pre-clinical trials, electroretinography (ERG) assessment of the efficacy of this device projects a 50% suppression of rod metabolism in the human eye. As described above, reducing rod metabolism lessens hypoxia and VEGF expression.

[0026] Another approach by researchers at Caltech suspended a GTLS in the vitreous in a “chandelier” style implant. This implant was fashioned in a style similar to a glaucoma drainage device, which is implanted through an incision at the pars plana. The device used an internal hemispherical gasket and exterior backplate as an anchoring system.Diabetic retinopathy manifests in a variety of ways across the retina, largely due to its anatomy. The peripheral retina is less oxygenated than the macula, due to its relative lack of vasculature. In a patient with diabetic retinopathy, this makes the peripheral retina more hypoxic than the macula, making it the main expressor of intraocular VEGF. Therefore, there is a strong incentive to include a feature that directs phototherapy to the peripheral retina. Such a design is elegant as the peripheral retina is primarily responsible for peripheral, low-fidelity vision, while the macula is responsible for central, high-fidelity vision. Hence, by limiting phototherapy to the peripheral retina, any side effects associated with phototherapy will only be seen on the patient’s peripheral vision.

[0027] Previous GTLS-based phototherapy device designs developed at Caltech have served as an adequate proof-of-concept for ocular phototherapy, but do not leverage the GTLS’ adaptability to a plethora of embodiments best suited for use in various scenarios. For clinical relevance, significant improvements and considerations must be made to ensure a safe and effective device. This patent disclosure describes such improvements.

[0028] SUMMARY OF THE INVENTION

[0029] Problem Addressed: Retinal diseases and conditions with a hypoxic etiology including, diabetic retinopathy, diabetic macular edema, age-related macular degeneration, retinal vein occlusion, retinopathy of prematurity, and glaucoma. The inventions described in this patent disclosure seek to address the problems and limitations associated with prior art describing implantable phototherapy devices. Specifically, some of the problems addressed include compromised night vision, unstable light output, access to anti-VEGF therapies, manufacturing and cost, device replacement, and radiation safety.

[0030] The Table 1 below describes the various solutions offered by the various embodiments of the present invention.Solution Offered Key Features Advantages and Variations and Benefits Embodiments Illumination shaping • Definitive orientation Avoiding • An oblong anchor fixes of the device illumination of the tire device at a given macula or central orientation, from which • Shutter and / or reflector

[0031] vision can reduce an armature can orient the to shape illumination

[0032] the impact on night light source in a specific from light source

[0033] vision, as opposed position

[0034] to panretinal

[0035] illumination

[0036] Tunable coating • A coating can be Allows a specific • A bilayer coating of an selectively removed brightness to be erodible material covered from tire device to achieved and by an inert material increase its light output maintained over the • A laser or mechanical • Titrate light output for course of therapy, scratching can expose the patient specific needs, or as opposed to the erodible material, leading to compensate for a brightness decaying to the coating degrading decay in light brightness • The coating can be broken up into subregions to allow for spatial control of the erosion Combination therapy • Phototherapy can be Delays and / or • Implanting a

[0037] used in combination reduces need for phototherapy device and with anti-VEGF, doses. reducing dose or panretinal laser Addresses the extending period between photocoagulation, gene underlying hypoxia anti-VEGF injections therapy rather than just the • Phototherapy for VEGF panretinal or ex-macula regions with laser photocoagulation of select bleeds, problematic areas

[0038]

[0039] • Phototherapy with gene therapy

[0040] Drug eluting device • A photothcrapcutic Extends tire • Annular light source drug eluting device duration between with internal reservoir for refdls, beyond the drug; septum for refill typical 6 months and controlled release membrane, pore, or channel for drug deliver}' C ompartmentalization • Light source is Reduces exposure • A multi-light source of radioactive sources composed of multiple to patient or holster

[0041] independent operator in case of • Multiple light sources radioluminescent light device damage or are bonded or fused sources breakage together

[0042] • Light source (s) are

[0043] coated with a polymer

[0044] (e.g. Parylene) to reduce

[0045] change of GTLS

[0046] cracking, to mitigate

[0047] tritium escape in the

[0048] case of glass cracking, to

[0049] prevent glass fragments

[0050] from coming loose from

[0051] a broken device, and / or

[0052] to improve

[0053] biocompatability

[0054] Unibody design • A unibody chandelier • A unibody device • GTLS is formed with an style device is removes interfacial anchor, transscleral constructed form a failure modes and portion, backplate, entry GTLS streamlines tip, reflective coatings, manufacturing and and shape to properly logistics, as illuminate desired regions opposed to needing of the retina

[0055] to bond multiple

[0056]

[0057] parts and materials

[0058] together

[0059] Anchoring system with Allows for light sources Light intensity can • An annular construction removable holster to be added / removed to be modified without allows the light source to compensate for decay or removing the be extracted / swapped to titrate patient dose entirety of the without removing the with minimum device anchoring system disturbance to the • Light sources can clip surgical site or slip into holsters for easy replacement or addition

[0060] Phototherapeutic An anchor-free Avoids risk of • A series of light sources capsular bag ring phototherapy device that anchors, surgical are connected by flexible resides in the capsular site erosion, and / or linkers

[0061] bag infection, as • Tire device has a opposed to a circular resting state but transscleral anchor can be straightened out in covered by the an insertion tool for ease conjunctiva of implantation

[0062] • IOL can be connected to tire ring or utilize it as a haptic

[0063] Injectable Phototherapy Flexible linkers between Minimizes the • A wing or S

[0064] IOL GTLS in the haptics incision that needs configuration of the allow s the device to to be made for haptics can be made, with linearize to facilitate implantation and flexible linkers between injection through a small prevents large stress the GTLS forming the orifice from being applied haptics

[0065] to the GTLS, as • GTLS haptics should be opposed to a loaded into the inserter by traditionally loaded folding them away from IOL where haptics tire lens

[0066] fold over the lens

[0067]

[0068] and as opposed to

[0069] prior art where

[0070] GTLS are used

[0071] without flexible

[0072] linkers

[0073] Eliminate GTLS Use a metal tritide light Reduced risk of gas Replace GTLS with a chamber and phosphor source (MTLS) or solid bubble escaping chamber-free and more coating of wall state radioluminescent device in case of suitable radioluminescent (SSRL) such as a solid- breakage light source

[0074] state tritium matrix or

[0075] tritiated aerogel light Improved efficiency

[0076] sources to illuminate the of light generation

[0077] chamber

[0078] Tritium in close

[0079] proximity to phosphor to

[0080] improve efficiency

[0081]

[0082] TABLE 1

[0083] BRIEF DESCRIPTION OF THE DRAWINGS

[0084] The present invention can be more easily understood and the advantages and uses thereof more readily apparent when the detailed description of the present invention is read in conjunction with the figures wherein:

[0085] Figures 1 A- IF illustrate various views of a phototherapy chandelier.

[0086] Figures 2A- 2G illustrate various views of an implanted phototherapy chandelier.

[0087] Figures 3A - 3C illustrate various views of compartmentalized GTLS phototherapy device.

[0088] Figures 4A- 4C illustrate various views of an affixed compartmentalized GTLS phototherapy device.

[0089] Figures 5A- 5D illustrate various views of a phototherapy ring.

[0090] Figures 6A- 6E illustrate various views of a unibody GTLS backplate.

[0091] Figures 7A- 7E illustrate various views of a reverse taper unibody GTLS device.Figures 8A and 8B illustrate a wing-based intraocular lens device.

[0092] Figures 9A and 9B illustrate an intraocular lens device.

[0093] Figures 10A- 10F illustrate various views of drug eluting reservoir for use with various embodiments of a photoceutical device.

[0094] Figures 11A- HD illustrate a TLS-based chandelier implant.

[0095] Figures 12A- 12C illustrate various chandelier-based support structures for TLS-based light sources.

[0096] Figure 13 illustrates illumination of certain regions of the retina according to one embodiment of the present invention.

[0097] In accordance with common practice, the various described features are not drawn to scale but are drawn to emphasize specific features relevant to the invention. Like reference characters denote like elements throughout the figures and text.

[0098] DETAILED DESCRIPTION OF THE INVENTION

[0099] Additional technical information related to the various inventive photoceutical devices described herein and other photoceutical devices for illuminating the retina are described in the co-pending and co-owned patent application entitled, “Radioluminescent Eye Device for Modulation of Photoreceptor Metabolism,” application number 18 / 914507, filed on October 14, 2024. (Attorney Docket Number 11432-017.)

[0100] Dark adaptation of rod cells has been hypothesized to drive retinal hypoxia due to elevated metabolic demand, notably during long periods of darkness like while asleep. This can drive or exacerbate several retinal diseases and conditions including, diabetic retinopathy, diabetic macular edema, age-related macular degeneration, retinal vein occlusion, retinopathy of prematurity, and glaucoma. Rod cell metabolism can be reduced without impacting sleep or significantly compromising night vision through the application of low levels of static light to the retina. This can be achieved by placing a long lifetime light source in the eye, such as a radioluminescent source, gaseous tritium light source, metal tritide light source, solid-state radioluminescent light source, or a light emitting diode.

[0101] The present disclosure describes chandelier-style implants and drug eluting reservoirs where the light source is anchored to the eye via the sclera, as well as capsular bag rings.The invention comprises several embodiments each comprising various elements that can be combined to create an improved phototherapy device. In one embodiment, the device is a phototherapeutic implantable chandelier that is anchored at the pars plana region of the eye with an anchoring system that fixes to the sclera.

[0102] Light Source: Prior art (Caltech patents) teaches the use of biocompatible radioluminescent light source comprising one or more walls that form a chamber, such as in a GTLS. This introduces a significant risk in the case of breakage as a large gas bubble can escape the chamber and enter the eye. The inventors of the present disclosure teach that the chamber can be eliminated through the use metal tritide light source (MTLS), solid state radioluminescent light sources (SSRL), and tritiated aerogel light sources. The present phototherapeutic eye apparatus comprises a bulk material and thus is chamberless, i.e., a chamber is not present in the phototherapeutic eye apparatus.

[0103] Further, the prior art teaches that a phosphor material coats at least one of the one or more walls of the chamber. This is an inefficient means of generating light output, notably for GTLS, given the short pathlength of tritium.

[0104] Solid-state tritium matrix light sources and tritiated aerogel light sources overcome this limitation by distributing the phosphor and tritium throughout the volume of the device. In this manner, the tritium and phosphor are in close proximity, thereby increasing efficiency.

[0105] In MTLS, the close proximity of the metal tritide and the phosphor accomplish a similar goal. The integration of MTLS, solid-state tritium matrix light sources, and tritiated aerogel light sources into implantable phototherapy devices provides significant advantages over known techniques.

[0106] In one embodiment of a solid-state radioluminescent light source (SSRL), a mixture of tritiated metal powder and phosphor powder, is used to fill a glass capillary, which is sealed through methods well-known to those skilled in the art. The tritiated metal powder and phosphor powder are uniformly distributed. Beta particles emitted from the tritiated metal powder excite the phosphor throughout the capillary and emit light.

[0107] In another embodiment, a glass capillary is filled with a tritiated aerogel, throughout which phosphor powders are suspended. The glass capillary is sealed through methods well-known to those skilled in the art. Beta particles emitted from the tritiated aerogel excite the phosphor throughout the capillary and emit light.Thus, in the various presented embodiments the phosphor material that emits the photons (or another material that emits photons when stimulated) comprises a bulk material, in contrast to a coating on a chamber wall, as disclosed by the GTLS embodiments.

[0108] Surgical Incision and Implantation Site: Linear incision is made at the pars plana, preferably at the equator and on the medial side of the eye. Preferably a vertical or horizontal incision for ease of the surgeon aligning the device. A trocar or scalpel may be used. An alignment jig can be used to ensure proper positioning of the light source.

[0109] Oblong Anchor: A preferred means of anchoring the phototherapy device is to use a transscleral anchor that has an oblong profile (e.g. oval, ellipsoidal, rectangular, or diamond in cross-section) to align it with the incision, that is, a long dimension of the anchor is aligned with the incision. This enables a definitive position and orientation for the anchor and light source within the eye, which is critical for selectively illuminating specific regions of the retina. The incision will stretch and deform and the long axis of the anchor will align with the incision.

[0110] Alternatively, the transscleral anchor can be secured to other regions of the sclera, such as to maximally illuminate regions of interest or minimize illumination on regions (e.g. fovea). Suitable materials for the anchoring system may include biocompatible polymers, glass, silicone, acrylic / PMMA, DMAEM, polycarbonate, and poly(styrene-block-isobutylene-block-styrene) (SIBS).

[0111] Alternative Anchors: Eyelets can be integrated into the device to provide points for suturing to the ocular anatomy. A pair of magnets can be used to anchor the device by securing one to the device and fixing the other to ocular anatomy. For example, one magnetic can be placed under the conjunctiva to provide a means of securing the device without needing to span or pierce the sclera.

[0112] In another approach, one or more devices may be fixed in a plane secant to the sclera. This may be achieved through a plurality of transscleral incisions, through which mounting components are inserted. The light source is suspended by these mounting components, staying far from the optic pathway. This also reduces the length of the light source as a moment arm suspended in the vitreous, reducing its proclivity to cock in response to the eye’s rotation.

[0113] Some embodiments of the present invention use a bioadhesive to fix the device (GTLS, MTLS, SSRL) to ocular anatomy. Other embodiments may incorporate a textured surface, whichpromotes cell adhesion as a mode of device fixation. The light source may have tines or barbs to embed it into the eye tissue without need for transversing the anatomy.

[0114] Tapered Transscleral Profile: The transscleral anchor can have a tapered profile to provide an extrusion force, from compression of the surrounding scleral tissue. Taper may be a positive taper, which has a propensity to extrude from the eye; an additional internal retention plate, bumper, or ring prevents this and generates a seal. The taper may be a negative / reverse-taper, which has a propensity to extrude into the eye; an additional external retention plate, bumper, or ring can prevent this and generates a seal. Compressive forces from the transscleral anchor on the incision can help to stop bleeding and prevent the extrusion of fluid from the eye across the incision. The backplate can be made thin and small enough to be covered by the conjunctiva. A reinforced suture hole can be incorporated in the external portion of the fixture to achieve definitive orientation.

[0115] Armature: An armature can extend from the transscleral anchor at an angle to position the light source optimally in the eye. As an example, it may orient such that the central axis of a light source (e.g. cylindrical, prismatic GTLS, MTLS, SSRL) is normal to the macula of the eye. Such positioning minimizes light incident on the macula, to mitigate effects on visual acuity during low-light activities. The angle can be chosen to optimally position any shaped light source within the eye. Alternatively, the armature can position the light source to maximally illuminate the central retina or region of the eye experiencing greatest hypoxia. The armature can be made to maintain a fixed geometry or may be made of a deformable or bendable material (e g. metal) to reposition the armature. The armature can be made of a flexible material that can be retracted into a rigid sheath to convert from an angled orientation to a straight orientation. The armature may be fixed to the anchor or adjustable. For example, the anchor and armature may have a series of indexes (e.g. notches and grooves) that can be adjusted to. The indexes can control angle (e.g. like a clock) or depth (e.g. like a telescoping mechanism). The armature can also be adjusted by a clinician to customize and tailor the therapy, such as by having hinged or ball joints.

[0116] Light Receptacle: The armature can have a receptacle to receive a light source in a specific orientation and may affix to the light source mechanically (e.g. such as through a press-fit, latch, key, or Velcro), magnetically, or chemically (e.g. via adhesive, welding). It may be beneficial for the light source to be removable and replaceable and to tune the intensity orfrequency of the light output from the device. The receptable can have space for more than one light source. The receptacle may have an annular construction to allow a light source to be inserted or removed through the receptacle. The receptacle may be blunt ended with the light source to be inserted or removed from the end of the receptacle. The receptacle may have a side action for bolstering the light source.

[0117] Shutter: A reflective or opaque shutter may be placed at the end of the light source to prevent light from reaching the macula, central vision, or other regions of the retina. The shutter can be affixed to the light source or positioned at a distance from it by an armature. The shutter can be applied directly to the light source (e.g. by coating the end of a GTLS, MTLS, SSRL with an opaque film or depositing a coating). Alternatively, the shutter can be a separate element from the light source. A portion of the GTLS, MTLS, SSRL may be covered by an attachment, affecting the shape of the light cast onto the retina, such as by an opaque sleeve that slips onto a cylindrical GTLS, MTLS, SSRL. This device will cast light in a toroidal shape onto the retina, directly illuminating mostly the peripheral retina.

[0118] Insertion Tip: An insertion tip may be created by rounding or pointing the device to ease insertion through the incision. This can be done by rounding or pointing the shutter or top of the light source (GTLS, MTLS, SSRL). A trocar, needle, or blade may be integrated onto the end of the device to assist in making the incision automatically during insertion. Prior work utilized a cylindrical GTLS light source with flat entry end, which made insertion challenging for the surgeon.

[0119] Reflector: A reflector can be placed at the base of the light source to redirect light towards the retina. The reflector may be asymmetrically shaped to accommodate for ocular anatomy or surgical placement. The base or end of the light source can have a reflective coating. The reflector may be flat so that rays are not reflected at angle that circumvents the shutter and strikes the macula or unintended regions of the retina. The reflector should be designed such that reflected light does not get around the shutter. The reflector can dually function as a retention and / or sealing plate with respect to the incision. The reflector can be either a mirror or Lambertian reflector.

[0120] Reflective Coating: A reflective coating or reflector may be placed on the side of the light source to reduce radiance from the side nearest the retina and increase radiance on the side further from the retina. Patterning of the reflector or reflective coating can be designed to achievemore uniform radiance on the retina or otherwise shape the pattern of light. The coating can be deposited via chemical (e.g. vapor deposition, plating), physical (e.g. thermal evaporator, sputterer), or mechanical (e.g. wrapping, bonding, affixing) means. The reflective coating may consist of a metal, such as silver, aluminum, gold, platinum, rhodium, tungsten, copper, titanium, stainless steel, tantalum, zirconium, magnesium, chrome, iridium. Multi-layer and multi-material reflectors can also be used. The reflective coating may be further coated in a protective coating. The coating may be applied in linear, pixelated / digital, or analogue manner.

[0121] Tunable Light Output: Laser ablating, scratching, or otherwise compromising a dual layer coating can cause it to erode and open up area for light emission. This can allow the light output of the device to be tuned over time. A layer of erodible reflective material can be first deposited in the desired pattern and subsequently coated by an inert layer. When the inert layer is breached, fluid in the eye is able to degrade the erodible material and the coating can delaminate from the device. Tunable segments can have stalks that branch off from the main segment to a convenient location for access (e.g. near the eye surface). In another embodiment, the light source (e.g., GTLS, MTLS, SSRL) is coated with a photoablateable material that may be actively removed (e g., laser ablation), modifying the device’s light output.

[0122] In another embodiment, the light source is patterned with a reflective or non-transmissive surface (e.g. horizontal stripes) and placed in a sheath with a reflective or non-transmissive patterned surface (e.g. horizontal stripes). When the reflective or non-transmissive surfaces align with each other the flux of light out of the light source reduces; conversely, when the reflective or non-transmissive surfaces overlap with each other the flux out of the light source is increased. Intermediate positions can achieve intermediate light output. By moving the light source in or out with respect to the sheath, it is possible to tune the light output. Different patterning (e.g. vertical stripes) can be used to allow the light output to be adjusted by angular positioning of the light source within the sheath. Other pattering (e.g. spiral) can enable linear or angular positioning of the light source within the sheath to tune light output. The light source or sheath can have physical registrations to hold the positioning once set by the doctor. These approaches enable physicians to compensate for tritium decay and phosphor degradation or to tune the light output of the device to achieve a desirable dose to the patient. In practice, this approach may be informed by electroretinography and / or other biometrics to determine the correct light dose for a patient.Buoyancy: The device should be buoyancy-matched to the local eye fluid (e.g. vitreous humor) to mitigate relative movement during repositioning of the eye. This promotes synchronous motion of the chandelier (GTLS, MTLS, SSRL) and the eye, mitigating any strain the delayed motion of the chandelier would place on ocular tissue. Buoyancy matching may be selectively applied to the unsupported portion of the device (e.g. that in the vitreous). This can be achieved by varying the composition and geometry of the light source (e.g. type of glass, relative thickness of walls versus cavity, pressure of gas, amount of phosphor), type of material used in the construction of the anchor (e.g. silicone, polymer, metal, ceramic), adding weights to the device, adding void spaces to the device. A buoyancy-matched light source opens the possibility of an anchor-free phototherapy implant that floats within the vitreous.

[0123] Dual Therapy: A phototherapeutic device can be combined with conventional treatments for retinal diseases such as anti-VEGF therapy, gene therapy, and photocoagulation. The therapies may be delivered separately or in a combined product such as by via a phototherapeutic drug eluting reservoir as described further below. The combination of phototherapy and anti-VEGF therapy, gene therapy, and photocoagulation may improve patient outcomes and disease progression. For example, by combining phototherapy with anti-VEGF it may be possible to reduce the frequency or amount of dosing. It may also be possible to extend the time between filling of long-acting implants or drug eluting devices.

[0124] Phototherapeutic Drug Eluting Reservoir: An integrated phototherapeutic drug eluting reservoir can be constructed by making the exterior of the reservoir luminous through the use of GTLS, MTLS, SSRL, or LED. For example, an annular light source can comprise the body of the reservoir with septum and anchoring on one end and controlled release membrane on the other. In such an embodiment, an annular light source can be formed by fitting a smaller diameter glass capillary into a larger diameter glass capillary, coating the inside walls with phosphor, sealing one end of the capillaries (via methods well-known in the art such as laser welding), filling the inner compartment with tritium gas, and sealing the other end of the capillary. A mandrel can be placed through the smaller capillary to maintain the annular opening during sealing, cutting, or trimming. An annular MTLS can be formed by depositing an MTLS film onto the outer surface of the smaller cylinder, coating phosphor on the inner surface of the larger cylinder, fitting the smaller cylinder into the larger cylinder, and sealing the ends of thecylinders while maintaining a patent lumen. Prismatic versions of a drug delivery phototherapy devices are proposed as a variant from the annular example.

[0125] A construction similar to the Port Delivery System can be envisioned, where the exterior of the device is luminous. A phototherapeutic element may be affixed with the drug eluting reservoir or situated separately from it. In such an embodiment, a drug reservoir can be created by adjoining multiple GTLS, MTLS, SSRL elements next to one another in a palisade-like fashion, optionally bonded or bridges by a polymer, glass, or metallic, and circularized or otherwise made to close the surface. For example, an annular mold can be created, GTLS, MTLS, SSRL can be placed within the annulus, and the remaining space can be cast with silicone or moldable plastic. The top and bottom openings can be sealed with a septum and controlled drug delivery element. In another embodiment, various small GTLS, MTLS, SSRL are arranged in an annular pattern about the periphery of a cylindrical mold with a unilateral, oblong (or other shape) flange (or other anchor design, e.g. suturing holes), and cast in a polymer. The center of the cured cylinder is milled through without compromising the annular GTLS, MTLS, or SSRL array, forming a unilaterally flanged polymer tube whose exterior is patterned with light sources. The tube’s cavity is then outfitted to house a drug-eluting reservoir. On the extremity adjacent to the sclera, the reservoir is terminated by a component designed to enable drug reservoir filling, including but not limited to a needle-penetrable septum, a valve, or a nipple. The reservoir’s extremity which is immersed in the vitreous is terminated by a controlled release element (e.g., membrane) which informs the rate at which the drug is delivered to ocular anatomy.

[0126] Light Replacement: Light sources can be replaced as they reach their useful lifetime or to adjust brightness. Alight source can be removed by making an incision adjacent to the implant, using a tool to disconnect the light source from its receptacle, and extracting it from the incision. A new light source can be inserted through the incision and connected to the receptacle. The incision can then be sutured closed. Alternatively, for devices with an annular construction, the old light source can be gripped by a tool, through a small incision in the conjunctiva, and withdrawn from the anchoring system. An optional plug or valve in the anchoring system can close to prevent leakage from the eye. The new light source can be inserted through the annular opening and docked into the receptacle. A groove, lip, bulb, notch, ring, hook, or other means of improving mechanical gripping can be integrated into the light source to ease manipulation. Theannular design may further consist of an optically transmissive sheath into which the device is inserted. This can prevent extrusion of ocular fluid or disturbance to ocular anatomy and tissue during light source replacement.

[0127] Unibody Designs: While prior art has taught a two-part construction chandelier-like GTLS device, this introduces drawbacks including more complex manufacturing, opportunities for interfacial failures, and the need to validate multiple materials. We teach that there is considerable advantage to a unibody construction. A unibody GTLS or SSRL can be formed from glass, preferably featuring a flared base to prevent entry into the eye, a tapered and ellipsoidal transscleral element, a luminous body, patterned etchable reflectors, a pointed insertion tip, and an element shutter. Alternatively, eyelets can be integrated into the device to provide points for suturing to ocular anatomy. Any subset of the above features can be combined to produce a useful device. The described GTLS and SSRL embodiments can be formed into shape by thermal forming techniques from a base shape (e.g. cylinder, rectangle). Alternatively, the final shape with phosphor can be created (e.g. blow molding, fusing, slumping, deposition) and then the part can be loaded with tritium and sealed (e.g. laser, torchworking, fusing, welding, crimping, cold welding.

[0128] Compartmentalization of Radioluminescent Sources: Prior art has taught using a large (e.g. 1mm3to 1000mm3) radioluminescent light source in a phototherapy eye device; however, this design can be risky as it provides a single point of failure for all tritium to escape. We teach that several small (e.g. <lmm3) radioluminescent light sources (e g. GTLS, MTLS, SSRL) can be combined into a device to achieve the necessary light output while compartmentalizing and spreading the dose across multiple light sources. The smaller devices can be affixed to one another or to a main body, cast into a polymer, fused together, or otherwise integrated into the device. To further mitigate risk, the GTLS can be coated with a polymer (e.g. Parylene). The coating can insulate against mechanical stress or damage, mechanically confine glass in the case of rupture or breakage, and slow the leakage of tritium out of a damaged GTLS, MTLS, SSRL. The coating can also enhance the biocompatibility of the device. A coating can further enhance the mechanical attachment of the anchoring system to the GTLS, MTLS, SSRL Multispectral Light Sources: It is understood that different wavelengths can have different biological effects in the eye. For example, 498nm suppresses rod cell metabolism, 590nm inhibits vascular endothelial growth factor (VEGF) and increases metabolic activity inthe Retinal Pigment Epithelium (RPE); 660 nm maximizes absorption by Cytochrome C Oxidase to boost ATP production and reduce oxidative stress; 850 nm improves blood flow (via nitric oxide release) and reaches deeper choroidal tissues. An enhanced phototherapy light source can be generated by combining multiple light sources with different peak wavelengths, such as in the compartmentalized light source example. Alternatively, the phosphor used in the light source can be a mixture of phosphors that emit at the desired combination of wavelengths. Phosphors emitting from 400nm to lOOOnm may have utility.

[0129] Capsular Ring: While prior art has taught using an anchor that is mountable to an eye surface, this introduces drawbacks, including damage to the eye surface to which the device is mounted, a bulky design by virtue of the anchor, and opportunity for anchor site erosion. We teach that an anchor-free device can be constructed by forming radioluminescent light sources into a ring that can fit into the capsular bag. Segments of the ring can be formed with GTLS, MTLS, and / or SSRL with connecting elements between. The connecting elements are preferably made of a flexible material (e.g. polymer, silicone, PMMA, polycarbonate, SIBS) and may be curved to approximate the curvature of the capsular bag. The light sources can be straight or curved to approximate the curvature of the capsular bag. By using flexible connecting elements, the device can be straightened out in an inserting device (e.g. within a barrel) and only curl upon insertion into the capsular bag. The connecting elements can be chemically bonded to the light sources or mechanically coupled. The device may form a complete ring with the ends either connecting or abutting, or it may form a partial ring. Such a ring-like device can be placed in the capsular bag, but alternatively in the anterior chamber or posterior chamber.

[0130] Injectable Phototherapy IOL: IOLS are rolled up and squeezed through a small orifice during injection, which can damage or break the GTLS, MTLS, or SSRL. Using a technique of flexible linkers between light sources, an injectable IOL and haptics can be created. The GTLS with flexible linkers can form the haptics and take on a desired shape when resting; when loaded into the insertion device the haptics can linearize. The outer diameter of the GTLS, MTLS, or SSRL is chosen to fit through the bore of the injector.

[0131] Awing design may be particularly suitable to help with unfolding as it prevents the haptics and lens from intersecting during injection. First the first haptic enters the eye, then the lens, then the second haptic. A pair of curved GTLS, MTLS, or SSRL can be used in a wing configuration with a similarly curved injector. In such a case, the GTLS, MTLS, or SSRL cancomprise the entire haptic without the need for the linkers to generate the curved shape. For a traditional S-shape haptic, the device can be loaded with the haptics bent outwards from the lens, rather than in towards the lens as is conventionally done. Alternatively, an attachable and / or detachable IOL can be used with GTLS, MTLS, or SSRL haptics. Assembly of the device could take place in the eye. Additionally, a clip-on device bearing, enclosing, or otherwise featuring a GTLS, MTLS, or SSRL may be attached to the IOL haptics before the IOL is injected, or after the IOL has been deployed. In some embodiments, the clip-on device may additionally contain a drug reservoir for combination light / biologic therapy, such with the Bimatoprost Drug Pad-IOL or VisiLens.

[0132] The embodiments of the present invention are described below with reference to the figures

[0133] Figures 1A- IF illustrate an improved implantable phototherapy chandelier device 100, consisting of a backplate 101 to secure the device in the eye, a reverse tapered and ellipsoidal transscleral armature 102 to seal the incision and definitively orient the device. A holster / reflector 103 reflects light from a light source 105 toward the retina of an eye (not shown). Reference numeral 104 identifies a metallized surface of the holster / reflector. The radioluminescent light source (e.g. tritide light source, gaseous tritium light source) 105 provides the illumination, while a shutter 106 masks light from reaching specific regions of the retina. Numeral 107 designates opaque / reflector elements comprising a reflective or modulating coating designed to achieve the desired spatial light output and the distribution of light across the retina by masking parts of the light source luminescent area and / or redirecting more emitted light in a particular direction. Thus, light shines outward from the light source 105 between the regions labeled 107 directly onto the retina or upon reflecting from the reflector 103. The shape (reverse taper and ellipsoid in cross section) of the armature (in all three directions, X, Y, and Z) provides a self-sealing, suture-free implant.

[0134] The shutter 106 preferably casts a shadow on the macula and some area peripheral to it to ensure that the rod cells responsible for central night vision are not affected. The shadow diameter of about 6mm to 12mm is expected. The shadow further defines a soft border in the transition from dark to illuminated. The soft border helps prevent perception of the light source in the case of device movement. That can be accomplished with a gradient deposition on the shutter and / or by placing the shutter relatively close to the light source, with both of similar size.Figures 2A- 2H illustrate an improved implantable phototherapy chandelier device 200 is implanted at the pars plana 201 through a horizontal incision 202 (alternatively, vertical or angled), which orients the device within the eye. The illumination of the light source can be shuttered to prevent illumination of the central vision or macula 203. Reflectors or modulators on the light source can shape the illumination pattern to achieve a desired light intensity on the nearby 204 and distant 205 retina.

[0135] Figures 3A - 3C illustrate an implantable phototherapy chandelier device 300 can be improved through compartmentalization of the radioluminescent light source into multiple smaller light sources 301, which reduces the consequences of device damage to the eye or breakage. A multi-light source holster 302 provides anchoring to the various sources and can be fitted to a reflector 303 and ocular anchoring system 304.

[0136] Figures 4A- 4C illustrate an implantable phototherapy chandelier device 400 can be improved through compartmentalization of the radioluminescent light source into multiple smaller light sources 401, which reduces the consequences of device damage or breakage. The multi-light sources can be cast or affixed into a singular body 402 that can be fitted to a reflector 403 and ocular anchoring system 404. A rounded shutter 405 can serve to improve the ease of implantation and mask light from striking certain regions of the retina.

[0137] Figures 5A- 5D illustrate an implantable phototherapy ring device 500 implanted within the capsular bag 501. The device comprises radioluminescent light sources (e.g. tritide light sources or gaseous tritium light sources) 502 joined in a ring-like structure by flexible linkers 503 between two consecutive light sources 502. The flexible linkers 503 enable the device to be linearized for purposes of insertion into the lens capsule through a small incision. The ends of the ring 504 may be open or lockable. A reflective coating or reflectors 505 (see Figure 5D) or modulating elements can be added to the light sources to redirect or reshape the illumination onto the retina. The ring can act as a haptic for attachment of an intraocular lens.

[0138] Figures 6A- 6E illustrate a unibody implantable phototherapy chandelier device 600 can be formed from a single gaseous tritium light source 601 using a backplate 602 to secure the device in the eye, a tapered and ellipsoidal transscleral armature 603 to seal the incision and definitively orient the device. An insertion tip 604 can be generated by rounding or pointing the end of the GTLS and it may also include a shutter 605 by metallizing it to mask light fromreaching specific regions of the retina 606. Reflective or modulating coatings 607 on the light source can help to achieve the desired spatial light output.

[0139] Figures 7A- 7E illustrate a unibody implantable phototherapy chandelier 700 formed from a single gaseous tritium light source 701 by generating a reverse taper anchoring element 702 to secure the device and definitively orient the device. A flange 703 can prevent device egress from the eye and help to seal the incision. An insertion tip 704 can be generated by rounding or pointing the end of the GTLS and it may also serve as a shutter by metalizing it to mask light from reaching specific regions of the retina. Reflective or modulating coatings 705 on the light source can help to achieve the desired spatial light output.

[0140] Figures 8A and 8B illustrate an improved phototherapeutic wing intraocular lens 800 that is extrudable through an injector by having haptics 801 composed of radioluminescent light sources 802 connected by flexible linkers 803 and connect to the lens 804. The device is loaded into the injector by linearizing the haptics and rolling the lens. This configuration minimizes the bore that the device can be extruded through without damaging the radioluminescent sources.

[0141] Figures 9A and 9B illustrate an improved phototherapeutic intraocular lens 900 that is extrudable through an injector by having haptics 901 composed of radioluminescent light sources 902 connected by flexible linkers 903 and connected to the lens 904. The device is loaded into the injector by linearizing the haptics and rolling the lens. This configuration minimizes the bore that the device can be extruded through without damaging the radioluminescent sources.

[0142] Figures 10A- 10F illustrate an implantable phototherapy drug eluting reservoir device 1000 formed from an annular or hollow radioluminescent light source 1001. The internal reservoir 1002 can be filled with an ophthalmic drug like an anti-VEGF or glaucoma medication, optionally through a septum 1003 on the surface of the eye. The septum would be concentric with the oblong anchor and is essentially a membrane through which a needle can be passed for refilling of the drug reservoir. As such the label should point to the center of the oblong anchor (backplate). The device can be anchored with a backplate 1004 and transscleral element 1005, which can be made hollow to increase the reservoir volume. A controlled release membrane 1006 can plug the reservoir and modulate the rate of drug delivery into the eye; it may also serve as a shutter to prevent illumination of certain regions of the retina. Reflective elements 1007 and modulating or reflective coatings can be added to shape the light output.Figures 11 A - 1 ID illustrate an improved GTLS-based phototherapeutic device. This chandelier- style GTLS implant may feature one or multiple eyelets 1112 in Figure 11 A, 1122 in Figure 11B, 1132 in Figure 11C, and 1142 in Figure 11D, on the GTLS 1111. The improved device may alternately be affixed to an interior surface of the eye with a holster, as described below, to which the GTLS is mounted. These eyelets enable fixation via a knotted suture 1144 as depicted in Figure 11D. Element 1110 (Figure 11A) is a GTLS with a single, symmetrical eyelet 1111 fabricated coaxial to the GTLS. Element 1120 (Figure 11B) is a GTLS featuring two opposed eyelets 1122 on the GTLS’ curved face 1121, which may offer greater surgical control and postop stability. Element 1130 (Figure 11C) is a GTLS 1131 inserted into a holster 1133 bearing two horizontally opposed, downward-facing eyelets 1132. Element 1140 (Figure 11D) is a GTLS 1141 inserted into a holster 1143 featuring two horizontally opposed, downward-facing eyelets 1142 and a dome-like cavity 1144. The dome-like cavity 1144 is utilized as a space in which a suture knot may be tucked during insertion of the chandelier implant. This approach minimizes contact between foreign bodies and ocular / orbit tissue.

[0143] Figures 12A- 12C illustrate an improvement over a prior art GTLS chandelier implant. It is recognized, however, that other tritium-based light sources can be used in place of the GTLS described with reference to Figures 12A- 12C. Similarly, in other embodiments that refer to use of a GTLS, other TLS light sources can be substituted for the GTLS.

[0144] The prior art GTLS chandelier devices did not feature patient customizability because they lacked adjustable components. The improved embodiments of a chandelier GTLS implant 1200, depicted in Figures 12A- 12C features the insertion of the GTLS into a holster 1213 featuring a mechanical joint 1212, 1211 (e.g., hinges, ball joint) by which the GTLS’ angle 1221 may be adjusted and thereby fixed at a desired angle. As seen in configuration 1220 (Figure 12C) this embodiment offers the surgeon case-by-case tunability, to vary the GTLS’ emitted light distribution, as well as avoid any optical obstruction the GTLS may cause. The GTLS implant 1200 includes features that mitigate inefficiencies in phototherapy due to the dissipation of light onto a non-target anatomy. Non-therapeutic light may be redirected to the target anatomy (e.g., retina, photoreceptors) by an additional optical feature, such as a reflective, metallized dome 1214 (see Figure 12A). Such a reflective dome may be designed to concentrate all light emanated by the GTLS 1211 into a cone defined by circles 1215, 1217 that is directed at the target anatomy. The designed propagation of phototherapeutic light may be synergistically informed byboth a reflector and the previously mentioned dynamic / adjustable chandelier fixation device 1212. Registrations at the joint may allow the device to take on discrete positions and cause the light to be directed onto preferred surfaces.

[0145] Figure 13 illustrates how one can maintain dark adaptation and night vision by casting a shadow 1300 over the macula or desired region of retina. The armature 1302 of the implant orients the light source 1303 and shutter 1304 (also referred to as a mask) to illuminate the adjacent retina but not the macula or desired region of retina. A transitional zone of illumination 1301 is established to mitigate the perception of light due to the movement of the armature or light source, enhancing the Troxler effect.

Claims

WHAT IS CLAIMED IS:

1. A phototherapeutic eye apparatus, comprising:a backplate for placing in contact with the sclera when thephototherapeutic eye apparatus is inserted in an eye;a light source; andan armature disposed between the backplate and the light source, wherein a cross sectional dimension of the armature tapers down from a first cross sectional dimension nearest the light source to a second cross sectional dimension nearest the backplate.

2. The phototherapeutic eye apparatus of claim 1, further comprising a filter, reflector, or shutter responsive to the light emitted from the light source for directing and shaping an illumination pattern of the light on a preferred region of the retina.

3. The phototherapeutic eye apparatus of claim 2, wherein one or both of the armature and the shutter are adjustable to illuminate a preferred region of the retina.

4. The phototherapeutic eye apparatus of claim 1, wherein the preferred region comprises a peripheral retina.

5. The phototherapeutic eye apparatus of claim 1, wherein the light source comprises a tritium light source, a gaseous tritium light source, a metal tritide light source, a solid state radioluminescent light source, a solid-state tritium matrix light source, a tritiated aerogel light source, or a tritiated polymer light source.

6. The phototherapeutic eye apparatus of claim 1, wherein the light source comprises a solid state beta flux source for emitting beta particles, and a bulk luminophore material for receiving the beta particles and responsive thereto emitting photons.

7. The phototherapeutic eye apparatus of claim 6, wherein the solid state beta flux source comprises a metal film or a metal lattice with tritium disposed within the metal film or within the metal lattice, and wherein a rate of photons emitted from phototherapeutic eye apparatus is responsive to an amount of disposed tritium.

8. The phototherapeutic eye apparatus of claim 6, wherein a material of the metal film or the metal lattice comprises titanium, scandium, magnesium, palladium, yttrium, ytterbium, or an alloy comprising one or more of titanium, scandium, magnesium, palladium yttrium, or ytterbium.

9. The phototherapeutic eye apparatus of claim 6, wherein the solid state beta flux source comprises a metal film or metal granule(s) hydrogenated with tritium or comprises an organic molecular substance hydrogenated with tritium, the organic molecular substance further comprising l,4-bis(phenylethynyl)benzene (DEB) or 1,4-diphenylbutadiyne (DPB).

10. The phototherapeutic eye apparatus of claim 6, wherein the solid state beta flux source and the bulk luminophore material have a thickness of 250 pm or less.

11. The phototherapeutic eye apparatus of claim 6, for implanting in an eye, wherein the solid state beta flux source comprises a metal tritide, and wherein when implanted in the eye the metal tritide, or the bulk luminophore material, or the metal tritide and the luminophore material are formed on one or more surfaces of the phototherapeutic eye apparatus.

12. The phototherapeutic eye apparatus of claim 6, wherein the solid state beta flux source comprises a metal tritide, the phototherapeutic eye apparatus further comprising a substrate on which the metal tritide and the luminophore material are disposed, wherein a surface area of the substrate is determined to provide surface area for the metal tritide and the luminophore material, wherein the surface area is formed by micromachining, embossing, etching, electrospinning, coating with microparticles or nanoparticles, electrochemical roughening, abrasion, leaching, or a metal-organic framework, resulting in three-dimensional metal tritide and / or luminophore components.

13. The phototherapeutic eye apparatus of claim 1, wherein the armature is coupled to the backplate, and wherein the backplate and the armature form an angle that directs an illumination pattern of light on a preferred region of the retina.

14. An ocular device for implanting in or wearing on an eye, the ocular device comprising one or more of the phototherapeutic eye apparatus of claim 1, further comprising a plurality of liquid crystals controlled by a piezoelectric converter, the piezoelectric converter controlled by an ocular anatomy component for generating a current to control the plurality of liquid crystals in response to an ambient light level, such that when the eye light-adapts the plurality of liquid crystals are controlled to an opacified state, and when the eye dark-adapts the plurality of liquid crystals are controlled to a translucent state.

15. The phototherapeutic eye apparatus of claim 1 , defining a nose at a forward end of the phototherapeutic eye apparatus, wherein a shape of the nose defines a rounded shape or a pointed shape for ease of inserting the phototherapeutic eye apparatus through an incision into the eye.

16. The phototherapeutic eye apparatus of claim 1, wherein a cross sectional shape of the armature comprises an oval-shape, an ellipsoidal-shape, a rectangular-shape, or a diamondshape.

17. The phototherapeutic eye apparatus of claim 1, further comprising a drug eluting reservoir for releasing a drug into the eye when the phototherapeutic eye apparatus is disposed within the eye.

18. The phototherapeutic eye apparatus of claim 1, wherein the light source comprises a plurality of discrete light-emitting elements configured to operate in coordination to provide a unified light output.

19. The phototherapeutic eye apparatus of claim 1, further comprising light absorbing or light reflecting coatings for shaping an illumination pattern created by light emitted from the light source.

20. A phototherapeutic eye apparatus, comprising:a backplate;a first end of an oblong armature affixed to and extending from the backplate, a reflector affixed to a second end of the armature;a cross sectional dimension of the armature tapering downwardly from the second end of the armature to the first end of the armature;a coupling element affixed to the reflector or to the second end of the armature;a light source affixed to the coupling element and extending away from the reflector; and a component responsive to light emitted from the light source for directing and shaping an illumination pattern of the light.

Images