System and method for treating eye with mask device

Abstract

To employ a mask device to treat an eye with a photosensitizer, e.g., cross-linking treatment.SOLUTION: An eye treatment positions the mask device over first and second eyes. A posterior side of the mask device is proximate to the face and the anterior side is distal from the face. The mask device includes an outer wall extending between the anterior and posterior sides and defining a chamber extending across the first and second eyes. The anterior side includes a first transmission region that allows a photoactivating light for the first eye to be delivered into a first section of the chamber positioned over the first eye. The anterior side includes a second transmission region that allows a photoactivating light for the second eye to be delivered into the second section positioned over the second eye. The system includes at least one gas source storing a gas that is different from ambient air. The system includes a gas delivery system that delivers the gas into the chamber.SELECTED DRAWING: Figure 12A

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to and the benefit of U.S. Provisional Patent Application No. 62 / 262,900, filed December 3, 2015, the entire contents of which are incorporated herein by reference.

[0002] 2. Background of the Invention Technical Field The present disclosure relates to systems and methods for treating ocular disorders, and more particularly to systems and methods that employ a mask device to treat the eye with photosensitizers, such as crosslinking treatments.

[0003] Background technology Crosslinking procedures can be employed to treat eyes suffering from disorders such as keratoconus. In particular, keratoconus is a degenerative disorder of the eye in which structural changes in the cornea weaken it and cause it to change into an abnormal conical shape. Crosslinking procedures can strengthen and stabilize the areas weakened by keratoconus, preventing undesirable shape changes.

[0004] Crosslinking procedures can also be employed after surgical procedures, such as laser in situ keratomileusis (LASIK) procedures. For example, a complication known as LASIK ectasia can occur due to the thinning and weakening of the cornea caused by LASIK surgery. In LASIK ectasia, the cornea undergoes progressive steepening (bulging). Therefore, crosslinking procedures can strengthen and stabilize the structure of the cornea after LASIK surgery and prevent LASIK ectasia.

[0005] Summary of the Invention According to aspects of the present disclosure, systems and methods employ a mask device to treat an eye with a photosensitizer, e.g., a crosslinking treatment. By way of example, according to one embodiment, a system for treating an eye includes a mask device configured to be positioned on a face over a first and second eye. The mask device includes a front side and a rear side. The rear side is configured to be positioned proximate to the face and the front side is configured to be positioned distal to the face. The mask device includes an outer wall extending at least between the front side and the rear side. The outer wall defines a chamber extending between the first and second eyes. The chamber includes a first section and a second section. The first section is configured to be positioned over the first eye. The second section is configured to be positioned over the second eye. The front side includes a first transparent region disposed over the first section and a second transparent region disposed over the second section. The first transparent region allows a first photoactivating light for the first eye to be delivered to the first section. The second transparent region allows a second photoactivating light for a second eye to be delivered to the second section. The system includes at least one gas source that stores a gas different from ambient air. The system includes a gas supply system that connects the at least one gas source to the mask device. The gas supply system is configured to deliver the stored gas to a chamber of the mask device.

[0006] According to another embodiment, a method for treating an eye includes positioning a mask device on a face over a first and a second eye. The mask device includes a front side and a rear side. The rear side is configured to be positioned proximate to the face and the front side is configured to be positioned distal to the face. The mask device includes an outer wall extending at least between the front side and the rear side. The outer wall defines a chamber extending between the first and second eyes. The chamber includes a first section and a second section. The first section is configured to be positioned over the first eye. The second section is configured to be positioned over the second eye. The front side includes a first transparent region disposed over the first section and a second transparent region disposed over the second section. The method includes at least one of providing a first photoactivating light to the first eye through the first transparent region or providing a second photoactivating light to the second eye through the second transparent region. The method includes providing a gas different from ambient air from at least one gas source to the chamber of the mask device. At least one gas source is coupled to the mask apparatus via a gas delivery system. [Brief description of the drawings]

[0007] [Figure 1] 1 illustrates an exemplary system for delivering a cross-linking agent and photoactivating light to a cornea of ​​an eye to cause cross-linking of corneal collagen, according to aspects of the present disclosure. [Figure 2A] 1 illustrates a photochemical kinetic reaction diagram involving riboflavin and photoactivatable light (e.g., ultraviolet A (UVA) light) applied during a corneal crosslinking procedure, according to an embodiment of the present disclosure. [Figure 2B] 2B illustrates a diagram of parameters that can affect the photochemical kinetic reaction shown in FIG. 2A. [Diagram 3] 1 illustrates an exemplary system employing a model of photochemical kinetic reactions, according to an aspect of the present disclosure. [Figure 4]1 illustrates an exemplary system that employs a model of photochemical kinetic responses to provide treatment parameters for achieving desired biomechanical changes, according to aspects of the present disclosure. [Diagram 5] 1 illustrates an exemplary method of employing a model of photochemical kinetic responses to determine treatment parameters to achieve desired biomechanical changes, according to aspects of the present disclosure. [Figure 6] 1 illustrates an exemplary system for applying an ocular treatment with a mask device, according to aspects of the present disclosure. [Figure 7] 1 illustrates another exemplary system for applying an ocular treatment with a mask device, according to aspects of the present disclosure. [Figure 8] 1 illustrates yet another exemplary system for applying an ocular treatment with a mask device, according to aspects of the present disclosure. [Figure 9] 1 illustrates a further exemplary system for applying an ocular treatment with a mask device, according to aspects of the present disclosure. [Figure 10] 1 illustrates yet a further exemplary system for applying an ocular treatment with a mask device, according to aspects of the present disclosure. [Figure 11] 1 illustrates an additional exemplary system for applying an ocular treatment with a mask device, according to aspects of the present disclosure. [Figure 12A] 1 illustrates an exemplary system for applying ocular treatment with a mask apparatus, where the treatment system employs an external oxygen gas source, according to aspects of the present disclosure. [Figure 12B] 12B further illustrates the exemplary system of FIG. 12A, where oxygen gas is supplied from an external oxygen gas source with minimal turbulence / backpressure, according to an embodiment of the present disclosure. [Figure 12C] 12A-B illustrate a detailed view of a mask device of the exemplary system. [Figure 12D] 12C, in which the diffuser delivers oxygen gas with minimal turbulence / backpressure, according to an embodiment of the present disclosure.

[0008] While the disclosure is susceptible to various modifications and alternative forms, specific embodiments thereof have been shown by way of example in the drawings and are herein described in detail, it being understood, however, that it is not intended to limit the disclosure to the particular disclosed forms, but rather, the intention is to cover all modifications, equivalents and alternatives falling within the spirit of the disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0009] FIG. 1 illustrates an exemplary treatment system 100 for causing cross-linking of collagen in a cornea 2 of an eye 1. The treatment system 100 includes an applicator 132 for applying a cross-linking agent 130 to the cornea 2. In an exemplary embodiment, the applicator 132 can be an eye dropper, syringe, or the like that applies the photosensitizer 130 as drops to the cornea 2. The cross-linking agent 130 can be provided in a formulation that allows the cross-linking agent 130 to pass through the corneal epithelium 2a to the subcutaneous region of the corneal stroma 2b. Alternatively, the corneal epithelium 2a can be peeled or otherwise incised to allow the cross-linking agent 130 to be applied more directly to the subcutaneous tissue.

[0010] The treatment system 100 includes an illumination device with a light source 110 and an optical element 112 for directing light to the cornea 2. The light causes photoactivation of a crosslinking agent 130 to produce crosslinking activity in the cornea 2. By way of example, the crosslinking agent can include riboflavin and the photoactivating light can include ultraviolet A (UVA) (e.g., about 365 nm) light. Alternatively, the photoactivating light can include another wavelength, such as a visible wavelength (e.g., about 452 nm). As described further below, corneal crosslinking improves corneal strength by creating chemical bonds in the corneal tissue through a system of photochemical kinetic reactions. By way of example, riboflavin and the photoactivating light can be applied to stabilize and / or strengthen the corneal tissue to address conditions such as keratoconus or post-LASIK ectasia.

[0011] Treatment system 100 includes one or more controllers 120 that control aspects of system 100, including light source 110 and / or optical elements 112. In embodiments, the cornea 2 can be treated more broadly with crosslinking agent 130 (e.g., with an eye dropper, syringe, etc.), and photoactivating light from light source 110 can be selectively directed to areas of the cornea 2 to be treated according to a particular pattern.

[0012] The optical element 112 can include one or more mirrors or lenses to direct and focus the photoactivating light emitted by the light source 110 in a specific pattern on the cornea 2. The optical element 112 can further include filters to partially block wavelengths of light emitted by the light source 110 and select specific wavelengths of light to be directed to the cornea 2 to photoactivate the crosslinking agent 130. In addition, the optical element 112 can include one or more beam splitters to split the beam of light emitted by the light source 110 and can include one or more heat sinks to absorb the light emitted by the light source 110. The optical element 112 can also accurately and precisely focus the photoactivating light to a specific focal plane within the cornea 2, for example, at a specific depth to the subcutaneous region 2b where crosslinking activity is desired.

[0013] Additionally, the particular conditions of the photoactivating light can be adjusted to achieve a desired degree of crosslinking in selected areas of the cornea 2. One or more controllers 120 can be used to control the operation of the light source 110 and / or optical elements 112 to precisely deliver photoactivating light with any combination of wavelength, bandwidth, intensity, power, location, depth of penetration and / or duration of treatment (exposure cycles, duration of dark cycles and ratio of exposure cycles to dark cycle duration).

[0014] The parameters for light activation of the cross-linking agent 130 can be adjusted, for example, to reduce the amount of time required to achieve the desired cross-linking. In an exemplary embodiment, the time can be reduced from minutes to seconds. Some instrument configurations use 5 mW / cm2 While applying the photoactivating light at an irradiance of 5 mW / cm, a greater irradiance of the photoactivating light, e.g., 5 mW / cm, may be used to reduce the time required to achieve the desired crosslinking. 2 The total irradiance of the energy absorbed by the cornea 2 can be described as the effective irradiance, which is the amount of energy absorbed through an area of ​​the corneal epithelium 2a. As an example, the effective irradiance for an area of ​​the corneal surface 2A can be, for example, 5 J / cm 2 or 20J / cm 2 Or 30 J / cm 2 The recited effective doses can be delivered from a single application of energy or from repeated applications of energy.

[0015] The optical element 112 of the treatment system 100 can include a digital micromirror device (DMD) to spatially and temporally modulate the application of the photoactivating light. Using DMD technology, the photoactivating light from the light source 110 is projected into precise spatial patterns generated by microscopically small mirrors placed in a matrix on a semiconductor chip. Each mirror represents one or more pixels in the projected light pattern. The DMD can perform topography-induced crosslinking. The control of the DMD by topography can employ several different spatial and temporal irradiance and dose profiles. These spatial and temporal dose profiles can be generated using continuous wave illumination, but can also be modulated via pulsed illumination by pulsing the illumination source at various frequency and duty cycle conditions as described above. Alternatively, the DMD can be modulated pixel by pixel with different frequencies and duty cycles to give the ultimate flexibility in using continuous wave illumination. Or alternatively, both pulsed illumination and modulated DMD frequency and duty cycle combinations can be combined. This allows for specific amounts of spatially determined corneal crosslinking. This spatially determined crosslinking can be combined with dosimetry, interferometry, optical coherence tomography (OCT), corneal topography, etc. for pre-treatment planning and / or real-time monitoring and adjustment of corneal crosslinking during treatment. Aspects of the dosimetry system are described in further detail below. Additionally, clinical pre-treatment patient information can be combined with finite element biomechanical computer modeling to generate patient-specific pre-treatment plans.

[0016] To control the aspects of the delivery of photoactivating light, embodiments can also employ aspects of multi-photon excitation microscopy. In particular, rather than delivering a single photon of a particular wavelength to the cornea 2, the treatment system 100 can deliver multiple photons of longer wavelengths, i.e., lower energy, that combine to initiate crosslinking. Advantageously, longer wavelengths scatter less within the cornea 2 than shorter wavelengths, allowing longer wavelength light to penetrate the cornea 2 more effectively than shorter wavelength light. Because light is absorbed by the photosensitizer much less at longer wavelengths, the shadowing effect of radiation incident at greater depths within the cornea is also reduced compared to conventional shorter wavelength illumination. This allows for improved control over depth-specific crosslinking. By way of example, some embodiments can employ two photons, each photon carrying approximately half the energy required to excite a molecule of the crosslinking agent 130 to cause a photochemical kinetic reaction, as described further below. When a crosslinking agent molecule absorbs both photons simultaneously, it absorbs enough energy to release an active radical into the corneal tissue. Embodiments can also utilize lower energy photons, such that the crosslinker molecule must absorb, for example, three, four or five photons simultaneously to release an active radical. The likelihood of near simultaneous absorption of multiple photons is low, so a high flux of excitation photons may be required, which can be provided through a femtosecond laser.

[0017] A number of conditions and parameters affect the cross-linking of corneal collagen by the cross-linking agent 130. By way of example, the irradiance and dose of the photoactivating light affect the amount and rate of cross-linking.

[0018] When the cross-linking agent 130 is riboflavin among others, the UVA light can be applied continuously (continuous wave (CW)) or as pulsed light, the choice affecting the amount, rate and extent of cross-linking. When the UVA light is applied as pulsed light, the exposure cycle, the duration of the dark cycle and the ratio of exposure cycle to dark cycle duration affect the resulting corneal reinforcement. Pulsed light illumination can be used to produce greater or less reinforcement of corneal tissue than can be achieved by continuous wave illumination of the same amount or dose of delivered energy. Light pulses of suitable length and frequency can be used to achieve more optimal chemical amplification. For pulsed light treatment, the on / off duty cycle can be about 1000 / 1 to about 1 / 1000 and the irradiance can be about 1 mW / cm. 2 ~About 1000mW / cm 2 The average irradiance can be from about 0.01 Hz to about 1000 Hz, or from about 1000 Hz to about 100,000 Hz.

[0019] The treatment system 100 can produce pulsed light by employing a DMD, electronically turning the light source 110 on and off, and / or using a mechanical or optoelectronic (e.g., Pockels cell) shutter or mechanical chopper or rotating aperture. Due to the pixel-specific adjustability of the DMD and subsequent stiffening based on the adjusted frequency, duty cycle, irradiance and dose delivered to the cornea, complex biomechanical stiffening patterns can be imparted to the cornea to allow for different amounts of refractive correction. These refractive corrections can involve, by way of example, a combination of complex corneal refractive surface corrections due to myopia, hyperopia, astigmatism, irregular astigmatism, presbyopia, and other diseases such as ocular diseases, e.g., keratoconus, pellucid marginal degeneration, post-LASIK ectasia, and biomechanical alterations / degeneration of the cornea. A particular advantage of the DMD system and method is that it enables topographic patterning of randomized asynchronous pulses, producing aperiodic and uniformly appearing illumination that eliminates the possibility of inducing photosensitive epileptic seizures or flicker vertigo for pulse frequencies between 2 Hz and 84 Hz.

[0020] Although the exemplary embodiment may employ a stepped on / off pulsed light function, it is understood that other functions for applying light to the cornea may be employed to achieve a similar effect. By way of example, light may be applied to the cornea according to a sinusoidal function, a sawtooth function, or other complex function or curve, or any combination of functions or curves. In fact, it is understood that the function may be substantially stepped, where there may be a more gradual transition between the on / off values. In addition, it is understood that the irradiance need not decrease to a value of zero during the off cycle, but may exceed zero during the off cycle. The desired effect may be achieved by applying light to the cornea according to a curve that varies the irradiance between two or more values.

[0021] Examples of systems and methods for delivering photoactivating light are described in, by way of example, U.S. Patent Application Publication No. 2011 / 0237999, entitled "Systems and Methods for Applying and Monitoring Eye Therapy," filed March 18, 2011; U.S. Patent Application Publication No. 2012 / 0215155, entitled "Systems and Methods for Applying and Monitoring Eye Therapy," filed April 3, 2012; and U.S. Patent Application Publication No. 2013 / 0245536, entitled "Systems and Methods for Corneal Cross-Linking with Pulsed Light," filed March 15, 2013, the entire contents of which are incorporated herein by reference.

[0022] The addition of oxygen also affects the amount of corneal reinforcement. In human tissue, the O2 content is very low compared to the atmosphere. However, the rate of crosslinking in the cornea is related to the concentration of O2 when it is irradiated by photoactivating light. Therefore, it may be advantageous to actively increase or decrease the concentration of O2 during irradiation to control the rate of crosslinking until a desired amount of crosslinking is achieved. Oxygen can be applied in a number of different ways during the crosslinking procedure. One approach involves supersaturating riboflavin with O2. Thus, when riboflavin is applied to the eye, a higher concentration of O2 is directly delivered to the cornea along with the riboflavin, influencing the reaction involving O2 when the riboflavin is exposed to photoactivating light. According to another approach, steady state O2 (at a selected concentration) can be maintained at the surface of the cornea to expose the cornea to a selected amount of O2 and allow O2 to enter the cornea. 1, by way of example, treatment system 100 also includes an oxygen source 140 and an oxygen supply 142 that optionally supplies a selected concentration of oxygen to cornea 2. Exemplary systems and methods for applying oxygen during cross-linking treatments are described, by way of example, in U.S. Patent No. 8,574,277, entitled "Eye Therapy," filed October 21, 2010, and U.S. Patent Application Publication No. 2013 / 0060187, entitled "Systems and Methods for Corneal Cross-Linking with Pulsed Light," filed October 31, 2012, the contents of which are incorporated herein by reference in their entireties.

[0023] When riboflavin absorbs radiant energy, specifically light, it undergoes photoactivation. There are two photochemical kinetic pathways for riboflavin photoactivation, Type I and Type II. Some of the reactions involved in both Type I and Type II mechanisms are as follows:

number

[0024] In the reactions described herein, Rf represents riboflavin in the ground state. * 1 represents riboflavin in the excited singlet state. * 3 represents riboflavin in the triplet excited state. ·- is the reduced radical anion form of riboflavin. · is the radical form of riboflavin. RfH2 is the reduced form of riboflavin. DH is the substrate. DH ·+ is an intermediate radical cation. D · is a radical. D ox is the oxidized form of the substrate.

[0025] Riboflavin is in its triplet excited state Rf as shown in reactions (r1) to (r3). * 3. Triplet excited state Rf * From 3, riboflavin reacts further, generally according to a Type I or Type II mechanism. In the Type I mechanism, a substrate reacts with excited state riboflavin to produce a radical or radical ion by the transfer of a hydrogen atom or electron, respectively. In the Type II mechanism, excited state riboflavin reacts with oxygen to form singlet molecular oxygen. The singlet molecular oxygen then acts on tissue to create additional crosslinked bonds.

[0026] The oxygen concentration of the cornea is modulated by the UVA irradiance and temperature, and decreases immediately at the beginning of UVA exposure. By utilizing pulsed light of a particular duty cycle, frequency and irradiance, inputs from both type I and type II photochemical kinetic mechanisms can be employed to achieve a greater amount of photochemical efficiency. Furthermore, utilizing pulsed light allows for the rate of the reaction involving riboflavin to be modulated. The rate of the reaction can be either increased or decreased as needed by adjusting one of the parameters, such as irradiance, dose, on / off duty cycle, riboflavin concentration, soak time and others. Furthermore, additional components can be added to the cornea that affect the reaction and crosslinking rate.

[0027] If the UVA radiation is stopped shortly after oxygen depletion, the oxygen concentration begins to increase (replenish). Excess oxygen can be detrimental in the corneal crosslinking process because oxygen can inhibit the free radical photopolymerization reaction by interacting with radical species to form chain-terminating peroxide molecules. Pulse rate, irradiance, dose and other parameters can be adjusted to achieve a more optimal oxygen regeneration rate. Calculating and adjusting the oxygen regeneration rate is another example of adjusting reaction parameters to achieve a desired amount of corneal reinforcement.

[0028] Oxygen content can be depleted by various chemical reactions throughout the cornea, except in the very thin corneal layers where oxygen diffusion keeps up with the kinetics of the reactions. This diffusion-controlled zone gradually moves deeper into the cornea as the capacity of the stroma to take up oxygen decreases.

[0029] Riboflavin is reversibly or irreversibly reduced (inactivated) and / or photodegraded to a greater extent as irradiance increases. Photon optimization can be achieved by allowing reduced riboflavin to return to ground state riboflavin in a type I reaction. The rate of return of reduced riboflavin to the ground state in a type I reaction is determined by a number of factors. These factors include, but are not limited to, the on / off duty cycle of the pulsed light treatment, the pulse rate frequency, the irradiance, and the dose. In addition, riboflavin concentration, soak time, and the addition of other agents, including oxidizing agents, affect the rate of oxygen uptake. These and other parameters, including the duty cycle, pulse rate frequency, irradiance, and dose, can be selected to achieve more optimal photon efficiency and effectively use both type I as well as type II photochemical kinetic mechanisms for riboflavin photosensitization. Furthermore, these parameters can be selected in such a way as to achieve more optimal chemical amplification effects.

[0030] However, in addition to the above photochemical kinetic reactions (r1)-(r8), the inventors have also identified the following photochemical kinetic reactions (r9)-(r26) that occur during riboflavin photoactivation:

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[0031] Figure 2A illustrates the photochemical kinetic reaction diagrams provided in the preceding reactions (r1)-(r26). The diagram outlines the photochemical transformation of riboflavin (Rf) under UVA photoactivating light and its interaction with various donors (DH) via electron transfer. As shown, crosslinking activity can be achieved: (A) through the presence of singlet oxygen in reactions (r6)-(r8) (type II mechanism); (B) without the use of oxygen in reactions (r4)-(r17) (type I mechanism); and (C) through the formation of peroxides (HO), superoxides (O), and HO in reactions (r13)-(r17). - ) and the presence of the hydroxyl radical (·OH).

[0032] As shown in FIG. 2A, we also found that cross-linking activity arises to a greater extent from reactions involving peroxides, superoxides, and hydroxyl radicals. Cross-linking activity arises to a lesser extent from reactions involving singlet oxygen and from non-oxygen reactions. Some models based on reactions (r1)-(r26) can explain the level of cross-linking activity generated by each reaction. As an example, if singlet oxygen plays a smaller role in generating cross-linking activity, the model can be simplified by treating the resulting cross-linking activity from singlet oxygen as a constant.

[0033] All reactions are carried out using Rf3 as provided in reactions (r1) to (r3). * Start from Rf3 * Quenching of occurs through chemical reaction with ground state Rf in reaction (r10) and through inactivation by interaction with water in reaction (r9).

[0034] As previously described, excess oxygen can be detrimental to the corneal crosslinking process. As shown in Figure 2A, when the system becomes photon-limited and oxygen-rich, crosslinks can leave from further reactions involving superoxide, peroxide, and hydroxyl radicals. In fact, in some cases, excess oxygen can result in the destruction of net crosslinks versus the creation of crosslinks.

[0035] As described above, a wide variety of factors affect the rate of the crosslinking reaction and the amount of biomechanical stiffness achieved due to crosslinking. Many of these factors are interrelated, and changing one factor may have unexpected effects on another. However, a more comprehensive model for understanding the relationship between the different factors of the crosslinking treatment is provided by the photochemical kinetic reactions (r1)-(r26) identified above. Hence, the system and method can adjust various parameters for the crosslinking treatment according to this photochemical kinetic crosslinking model, which provides a unified description of oxygen dynamics and crosslinking activity. The model can be employed to evaluate the expected outcomes based on different combinations of treatment parameters and identify combinations of treatment parameters that provide the desired results. The parameters can include, by way of example and without limitation, the concentration and / or immersion time of the applied crosslinking agent; the dose, wavelength, irradiance, duration and / or on / off duty cycle of the photoactivating light; the oxygenation conditions of the tissue; and / or the presence of additional agents and solutions.

[0036] As shown in FIG. 2B, the system aspect of the reaction can be influenced by different parameters. As an example, the irradiance at which the photoactivating light is delivered to the system affects the photons available in the system, which in turn affects the Rf3 concentration for the subsequent reaction. *Also, providing more oxygen to the system stimulates oxygen-based reactions, while pulsing the photoactivating light affects the ability of reduced riboflavin to return to ground state riboflavin by allowing additional time for oxygen diffusion. Of course, other parameters can be varied to control the reaction system.

[0037] In an embodiment, FIG. 3 illustrates an exemplary system 100 employing a model based on the photochemical kinetic reactions (r1)-(r26) identified above to determine the amount of crosslinking resulting from treatment parameters and / or other relevant information. The controller 120 includes a processor 122 and a computer readable storage medium 124. The storage medium 124 stores program instructions for determining the amount of crosslinking when photoactivating light from the light source 110 is delivered to a selected area of ​​the cornea to be treated with a crosslinking agent. In particular, the photochemical kinetic model 126 based on the reactions (r1)-(r26) can include a first set of program instructions A for determining the amount of crosslinking resulting from reactions involving reactive oxygen species (ROS), including combinations of peroxides, superoxides, hydroxyl radicals, and / or singlet oxygen, and a second set of program instructions B for determining crosslinking from reactions not involving oxygen. The controller 120 receives input regarding the treatment parameters and / or other relevant information. Controller 120 can then execute program instructions A and B based on the input and output information regarding the three-dimensional crosslinking distribution of the selected region of the cornea. The three-dimensional crosslinking distribution can then be employed to determine how to control aspects of light source 110, optical element 112, crosslinking agent 130, applicator 132, oxygen source 140 and / or oxygen supply 142 to achieve the desired treatment in the selected region of the cornea. (Of course, system 100 and this process shown in FIG. 3 can be used for treatment of two or more selected regions of the same cornea.)

[0038] According to one embodiment, the three-dimensional crosslink distribution can be evaluated to calculate a threshold depth corresponding to a healing response due to crosslinking and the effect of reactive oxygen species in a selected region of the cornea. Additionally or alternatively, the three-dimensional crosslink distribution can be evaluated to calculate a biomechanical tissue stiffness threshold depth corresponding to a biomechanical tissue response in a selected region of the cornea. Information regarding the depth of the healing response and / or biomechanical tissue stiffness in the cornea can be employed to determine how to control aspects of the light source 110, the optical element 112, the crosslinking agent 130, the applicator 132, the oxygen source 140 and / or the oxygen supply 142. A particular healing response and / or biomechanical tissue stiffness may or may not be desirable at a particular depth of the cornea.

[0039] According to another embodiment, FIG. 4 illustrates an exemplary system 100 employing a photochemical kinetic model 126 to determine treatment parameters to achieve a desired biomechanical change, e.g., refractive correction, of the cornea. As in FIG. 3, the controller 120 includes a processor 122 and a computer-readable storage medium 124. However, in the example of FIG. 4, the storage medium 124 stores program instructions 125 for determining which treatment parameters can be employed to achieve the desired biomechanical change. The program instructions 125 are based on a photochemical kinetic model 126 that employs reactions (r1)-(r26) to determine the resulting crosslinks from (i) reactions involving reactive oxygen species (ROS), including combinations of peroxides, superoxides, hydroxyl radicals, and / or singlet oxygen, and (ii) reactions not involving oxygen.

[0040] Using the photochemical kinetic model 126, the resulting three-dimensional distribution of crosslinks throughout the treated corneal tissue can be determined for a combination of treatment parameters. As previously described, parameters for crosslinking treatment can include the concentration of applied crosslinking agent and / or soak time; the dose, wavelength, irradiance, duration, on / off duty cycle and / or other illumination parameters of the photoactivating light; oxygenation conditions of the tissue; and / or the presence of additional agents and solutions. The resulting distribution of crosslinks determined from the photochemical kinetic model 126 can be correlated with certain biomechanical changes in the cornea. As an example, there is a correlation between the distribution of crosslinks and refractive changes.

[0041] As shown in Fig. 4, controller 120 receives input 12 regarding an initial biomechanical state of the cornea and input 14 suggesting a desired biomechanical change of the cornea, e.g., refractive correction. The initial biomechanical state can be determined by, for example, the techniques described in previously referenced U.S. Patent Application Publication No. 2012 / 0215155. In some cases, input 12 can be provided by a metrology system communicatively coupled to controller 120. It is understood that the initial biomechanical state can reflect the condition of the cornea prior to or during any treatment.

[0042] The inputs 12, 14 are expressed in terms of corneal topography (i.e., shape), corneal strength (i.e., stiffness) and / or corneal thickness. By way of example, the desired biomechanical change in the case of refractive correction can be determined from a specified correction (by the physician) in diopters, e.g., "1.5 diopter correction."

[0043] A desired biomechanical change in the cornea may be correlated with a particular distribution of crosslinks as determined by photochemical kinetic model 126. As such, controller 120 may execute program instructions 125 to determine a particular distribution of crosslinks 16 that can produce the desired biomechanical change specified by input 14 in a cornea having an initial biomechanical state specified by input 12. After determining the distribution of crosslinks 16 for the desired biomechanical change, controller 120 may prescribe a set of treatment parameters to achieve the specified distribution of crosslinks.

[0044] The crosslink distribution 16 can in many cases be achieved by more than one set of treatment parameters. For example, depending on the photochemical kinetic reaction, a similar crosslink distribution can be achieved by applying (i) a lower dose of photoactivating light for a longer amount of time or (ii) a higher dose of photoactivating light for a shorter amount of time. Thus, more than one set of treatment parameters 18 for achieving the crosslink distribution 16 can be identified.

[0045] The two or more possible sets of treatment parameters 18 allow the physician to optimize the treatment for a particular preferred parameter, such as treatment time or photoactivating light dose. As an example, the physician may optimize the treatment parameters to achieve a shorter treatment time. For this preference, the controller 120 may define a set of illumination parameters that provide a larger dose of photoactivating light that produces a crosslinking distribution 16 over a shorter illumination period. Conversely, the physician may optimize the treatment parameters to employ a smaller dose of photoactivating light. For this second preference, the controller 120 may define a set of illumination parameters that provide a smaller dose of photoactivating light that produces a crosslinking distribution 16 over a longer illumination period.

[0046] In general, to achieve the crosslinking distribution 16, the controller 120 can identify any of the different combinations 18 of values ​​for the set of treatment parameters A, B, C, D, E, etc., as described above. The physician can set preferences for one or more of these treatment parameters. As an example, the physician can first set a preferred value or range of preferred values ​​for parameter A. In response, the controller 120 can specify combinations of values ​​for the remaining parameters B, C, D, E, etc., that satisfy the preference for parameter A while achieving the crosslinking distribution 16. The physician can make selections of values ​​for parameters B, C, D and / or E, etc., based on further preferences to arrive at an optimized set of treatment parameters 18a. The process of treatment parameter optimization can be iterative as values ​​of treatment parameters are incrementally adjusted to satisfy preferences having various priorities.

[0047] In some embodiments, a physician can manage the optimization process through a series of selections and other inputs via a user interface (not shown) coupled to the controller 120. In some cases, the inputs 12, 14 can also be provided through such a user interface.

[0048] The final set of treatment parameters 18a can then be employed to determine how to control aspects of the light source 110, optical element 112, crosslinking agent 130, applicator 132, oxygen source 140, oxygen supply 142, etc. to achieve the desired treatment in the selected area of ​​the cornea.

[0049] Correspondingly, FIG. 5 illustrates an exemplary method 600 for employing a model of photochemical kinetic responses (r1)-(r26) to determine treatment parameters to achieve a desired biomechanical change. In step 602, information regarding an initial biomechanical state of the cornea is received. In step 604, information regarding a desired biomechanical change of the cornea, e.g., refractive correction, is received. In step 606, a distribution of crosslinks is determined to achieve the desired biomechanical change of the cornea having the initial biomechanical state. In step 608, one or more sets of treatment parameters are determined to achieve the distribution of crosslinks. Corresponding to step 608, one or more preferences for the treatment parameters can be received in step 610, and the treatment parameters can be optimized in step 612 based on the one or more preferences to determine a final set of treatment parameters that can be embodied in a treatment system (e.g., exemplary system 100) to achieve the distribution of crosslinks.

[0050] Further aspects of the photochemical kinetic reactions provided in reactions (r1)-(r26) are described in U.S. patent application Ser. No. 15 / 140,184, entitled "Systems and Methods for Cross-Linking Treatments of an Eye," filed Apr. 27, 2016, the entire contents of which are incorporated herein by reference.

[0051] FIG. 6 illustrates an exemplary treatment system 300 for applying a bridging treatment to both eyes 1a, b of a patient. The embodiments of the treatment system described above can be incorporated into the treatment system 300. As shown in FIG. 6, the treatment system 300 includes a mask device 301 that is positioned on the patient's face 3 and configured to fit over both the right eye 1a and the left eye 1b. The mask device 301 can be held in place on the patient's face 3 by a strap (not shown) that can be worn around the patient's head. As such, in some embodiments, the mask device 301 can resemble a pair of goggles or the like. Alternatively, medical tape or the like can be applied to the mask device 301 and face 3 to hold the mask device 301 in place. Alternatively, the mask device 301 can be configured to rest stably against the patient's face 3 without additional support while the patient is lying on his / her back. In some cases, a speculum can be applied to each eye 1a, b to keep the eyelids open during the treatment. In such cases, the mask device 301 can be sized to fit around or otherwise accommodate the use of a speculum. The mask device 301 can be employed for crosslinking procedures with normal corneal epithelium (also known as "epi-on") or without normal corneal epithelium (also known as "epi-off").

[0052] The mask device 301 is defined by a body having an anterior side 301a and a posterior side 301b, with the anterior side 301a positioned distally from the face 3 and the posterior side 301b positioned proximate (e.g., leaning against) the face 3. The posterior side 301b may define an opening for receiving the face 3. The body includes an outer wall 301c extending between at least the anterior side 301a and the posterior side 301b. The wall 301c defines a chamber 302 extending between the right and left eyes 1a,b. The chamber 302 includes a right section 302a positioned over the right eye 1a and a left section 302b positioned over the left eye 1b. Each section 302a,b facilitates application of a crosslinking treatment to the cornea of ​​the respective eye 1a,b. The sections 302a,b may be physically separated by an interior wall 303, shown in Figure 6, to reduce any possibility of treatment of one eye affecting treatment of the other eye. Embodiments of the mask device 301 may be formed from plastic and / or other suitable materials.

[0053] A right applicator 332a and a left applicator 332b can be embodied for the right section 302a and the left section 302b, respectively. As shown in FIG. 6, the applicators 332a,b can be coupled to the mask device 301. The right applicator 332a can apply a first photosensitizer solution, e.g., a first riboflavin formulation, to the cornea of ​​the right eye 1a. The left applicator 332b can apply a second photosensitizer solution, e.g., a second riboflavin formulation, to the cornea of ​​the left eye 1b. By way of example, each applicator 332a,b can include an embodiment of an eye dropper, syringe, or the like, including a respective opening 333a,b through which the photosensitizer solution can be dripped or otherwise delivered to the cornea. The first photosensitizer solution and the second photosensitizer solution can have similar or different formulations, depending on the similarities or differences between the treatment of the right and left eyes 1a,b. Additionally, the first and second photosensitizer solutions may be applied to the respective right and left eyes 1a,b with similar or different immersion times.

[0054] In addition to employing applicators 332a,b to deliver an initial amount of photosensitizer solution to eyes 1a,b, applicators 332a,b (or other similar applicators) can further be employed to periodically irrigate eyes 1a,b to keep them moist during treatment. By way of example, eyes 1a,b can be irrigated with saline or additional photosensitizer solution. Applicators 332a,b or other similar applicators can also apply solutions containing other agents. By way of example, such agents can enhance the amount of cross-linking activity, particularly in the case of epi-on treatments. Other agents can reduce the cross-linking activity caused by the cross-linking agent. Still other agents can include antibiotics to provide antibacterial treatment.

[0055] The front side 301a includes a right transparent region 304a disposed on the right section 302a and a left transparent region 304b disposed on the left section 302b. The right transparent region 304a allows a first photoactivating light to be delivered to the right eye 1a through the right section 302a. The left transparent region 304b allows a second photoactivating light to be delivered to the left eye 1b through the left section 302b. As shown in FIG. 6, the right transparent region 304a and the left transparent region 304b are apertures through which the first photoactivating light and the second photoactivating light, respectively, can be delivered. The outer wall 301c can provide a structure for the front side 301a and can define apertures for the right transparent region 304a and the left transparent region 304b. When the eyes 1a,b are treated with a photosensitizer solution including, for example, riboflavin, the corresponding photoactivating light can be ultraviolet light, as described above.

[0056] The treatment system 300 may also include an illumination device 306 that may be positioned relative to the mask device 300 to deliver a first photoactivating light to the right eye 1 a or a second photoactivating light to the left eye 1 b. In some embodiments, the illumination device 306 may be supported separately, for example by a stand, above the right or left transparent region 304 a or 304 b.

[0057] The illumination device 306 can include aspects of the light source 110 and the optical element 112 as described above. Also, a controller 120 can be employed to control the light source 110 and / or the optical element 112. The first photoactivating light or the second photoactivating light can be delivered according to similar or different parameters depending on the similarities or differences between the treatment of the right eye and the left eye 1a,b. By way of example, the irradiance, illumination, pattern, pulse / continuous wave and other treatment parameters of the photoactivating light can be controlled as described above.

[0058] The mask device 301 allows a concentration of oxygen gas to be delivered to the eye 1a,b. As previously described, oxygen gas enhances or otherwise affects cross-linking activity during photoactivation. As shown in FIG. 6, each section 302a,b can include a respective oxygen source 340a,b coupled to the mask device 301. Oxygen from the right oxygen source 340a can be selectively released to the right section 302a through the right port 308a of the mask device 301. Oxygen from the left oxygen source 340b can be selectively released to the left section 302b through the left port 308b of the mask device 301. The release can be controlled by peeling seals 310a,b installed between the oxygen sources 304a,b and the ports 308a,b, respectively. As an example, the seals 310a,b can be pull-off tabs that can be manually peeled off by the physician. Although the first and second permeable regions 304a, 304b may be apertures, the chamber 302 is capable of retaining sufficient oxygen from the oxygen source 340a,b to control the crosslinking activity as desired. Indeed, oxygen gas is heavier than ambient air, which may fill the chamber 302 prior to delivery of oxygen gas, and ambient air may flow from the chamber 302 while oxygen gas remains in the chamber 302 (e.g., when the patient's face is on his back). As previously described, the rear side 301b of the mask device 301 may define an opening for receiving the face 3. To facilitate effective delivery of oxygen gas to the eyes 1a,b, the outer wall 301c along the rear side 301b is preferably shaped to form a substantially complete seal against the face 3 (e.g., to prevent leakage of oxygen gas, especially at the rear of the corneal surface). In some embodiments, oxygen gas may be delivered at substantially 2.5 L / min, but may be delivered effectively at a rate as low as about 1.0 L / min, for example.

[0059] If only one illuminator is available, eyes 1a,b can be treated with the photoactivating light alternately. As an example, as shown in Fig. 6, an illuminator 306 is positioned over the left transparent area 304b to deliver the second photoactivating light. The same illuminator 306 can also be repositioned over the right transparent area 304a to deliver the first photoactivating light to the right eye 1a after the second photoactivating light has been delivered to the left eye 1b.

[0060] Advantageously, the mask device 301 allows one eye to be treated with photoactivating light while allowing the other eye to be treated with a photosensitizer solution. As shown in FIG. 6, the right eye 1a can be bathed with a first photosensitizer solution from the applicator 332a while the left eye 1b receives photoactivating light after already being bathed in a second photosensitizer solution from the applicator 332b. After application of photoactivating light to the left eye 1b is completed, the illuminator 306 can be repositioned over the right transmission area 304a to deliver the first photoactivating light to the right eye 1a. By allowing both eyes 1a,b to undergo some treatment steps simultaneously, the total treatment time can be significantly reduced even when only one illuminator 306 is available. As an example, with the mask device, a single illuminator 306 can be used to treat at least four pairs of eyes in one hour, depending on the treatment parameters.

[0061] In general, the exemplary systems described herein can employ the photochemical kinetic model 126 to determine treatment parameters for achieving desired biomechanical changes in the cornea, as described above. As such, the treatment system 300 can be employed to implement parameters for the delivery of oxygen as well as photoactivating light according to the steps determined by the kinetic model 126. In an exemplary embodiment, the illumination device 306 can be irradiated with oxygen at a power of, for example, 1.5 mW / cm. 2 or 3mW / cm 2The treatment system 300 may be operated to apply UV light to the eye for an initial period, e.g., the first 5 minutes of a 30 minute treatment, at a low irradiance of 100 nm. The kinetic model 126 may suggest that crosslinking activity occurs at a desirable (e.g., optimal) rate without the addition of oxygen gas. However, after the initial period, the kinetic model 126 may suggest that crosslinking activity becomes oxygen limited. Thus, the treatment provided by the treatment system 300 may introduce oxygen gas from an oxygen source into the chamber 302 after the initial period.

[0062] While the exemplary embodiment of Figure 6 may employ only one illumination device 306, other embodiments may include two or more illumination devices 306. As shown in Figure 7, an exemplary treatment system 400 may include a right illumination device 406a positioned over the right transmissive region 304a and a left illumination device 406b over the left transmissive region 304b. In that way, the treatment system 400 allows both eyes 1a,b to be treated simultaneously.

[0063] Additionally, although the illumination device 306 of FIG. 6 may be separate from the mask device 301, the illumination devices 406a, b or aspects thereof may be fixedly coupled to the mask device 301 in some cases.

[0064] Although the applicators 332a,b in the exemplary embodiment of Figure 6 are coupled to the mask device 301, other embodiments may alternatively have such applicators separate from the mask device 301. As shown in Figure 8, the exemplary treatment system 500 may include another bridging applicator 532 that is selectively repositioned and introduced through the right transparent aperture 304a to apply a first photosensitizer solution to the right eye 1a or the left transparent aperture 304b to apply a second photosensitizer solution to the left eye 1b.

[0065] 6 may employ an interior wall 303 to separate the right section 302a from the left section 302b of the chamber 302, FIG. 9 illustrates an exemplary system 600 with a mask device 601 that omits the use of such a wall in the chamber 302. In this embodiment, the right and left sections 302a, 302b are not (completely) separated by structure, and oxygen gas entering the right section 302a can flow to the left section 302b, and vice versa. In this manner, both ports 308a,b can be used to fill the entire chamber 302 with oxygen gas.

[0066] 10 illustrates an exemplary system 700 that includes a mask device 701 with a single port 708 that is connected to an oxygen source 740. Oxygen supplied from the oxygen source 740 via port 708 fills both the right section 302a and the left section 302b of the chamber 302.

[0067] While the right and left transparent regions 304a, 304b of the exemplary embodiment of FIG. 6 can be apertures, FIG. 11 illustrates an exemplary system 800 with a mask device 801, which are windows formed from a transparent material that allows photoactivating light to pass through the chamber 302 and be applied to the eye 1a, b according to the desired treatment parameters. Advantageously, the mask device 801 provides an effective enclosure that can store the oxygen gas provided to the chamber 302 from the oxygen sources 340a, b. In some cases, such an enclosure allows the oxygen gas to be stored under a desired pressure. In further cases, the mask device 801 can include a vent that ensures that the oxygen gas does not create undesirable pressure in the chamber 302.

[0068] Although the oxygen sources 340a,b in the exemplary embodiment of FIG. 6 are coupled to the mask device 301, other embodiments may employ oxygen sources remote from the mask device. As shown in FIGS. 12A-D, an exemplary treatment system 900 includes a mask device 901 with a right port 908a leading to the right section 302a and a left port 908b leading to the left section 302b. The right port 908a and the left port 908b may be coupled to the same external oxygen source 940 via right and left tubes 909a,b, respectively. The right and left tubes 909a,b may extend to a y-splitter 909c that is coupled to the external oxygen source. By way of example, the external oxygen source 940 may be controlled by a valve to supply oxygen gas to the chamber 302. If the right section 302a and the left section 302b are not separated by an internal wall as shown in Figure 12B, oxygen gas supplied from the oxygen source 940 via both ports 908a,b will fill the entire chamber 302. Alternatively, if the right section 302a and the left section 302b are separated by an internal wall, oxygen gas supplied from the oxygen source 940 via ports 908a,b will fill each section 302a,b. Alternatively, the right port 908a and the left port 908b can be connected to separate external oxygen sources via right and left tubes 909a,b, respectively.

[0069] In general, the treatment system described herein is configured such that oxygen gas is introduced into the chamber with minimal turbulence and back pressure, and a desired amount of oxygen is predictably delivered to the eyes 1a,b. As also shown in FIG. 12B, such turbulence / back pressure can be minimized by directing the oxygen gas toward the temples 4a,b of the face 3. Specifically, the right port 908a leads to a right diffuser 911a that directs the oxygen gas toward the right temple 4a, and the left port 908b leads to a left diffuser 911b that directs the oxygen gas toward the left temple 4b. The diffusers 911a,b can be configured to angle the oxygen gas from the respective tubes 909a,b through the openings in the posterior side 301b toward the respective temples 4a,b. In addition to minimizing turbulence and back pressure, the oxygen gas is directed not to flow directly onto the eyes 1a,b, thereby minimizing undesirable drying of the eyes 1a,b. Once the oxygen gas reaches the temples 4 a,b, it flows over the eyes 1 a,b. As previously described, oxygen gas is heavier than ambient air, which may fill the chamber 302 prior to delivery of the oxygen gas, and the oxygen gas is allowed to remain in the chamber 302 above the eyes 1 a,b.

[0070] FIG. 12C further illustrates an embodiment of the mask device 901. By way of example, the mask device 901 can be approximately 21.5 cm from right to left along the y-axis as shown, approximately 8.5 cm from top to bottom along the z-axis as shown, and approximately 9.5 cm from front to back along the x-axis as shown. FIG. 12D further illustrates, by way of example, one of the diffusers 911a,b with respective angled surfaces 912a,b and other structures directing oxygen air to respective temples 4a,b. As shown, the respective ports 908a,b can also be angled (in combination with the angled surfaces 912a,b) to more efficiently direct the oxygen air. By way of example, the diffusers 911a,b can be approximately 2.2 cm along the y-axis as shown, approximately 2.2 cm along the z-axis as shown, and approximately 1.9 cm along the x-axis as shown.

[0071] In general, the embodiments may employ at least one gas source that stores a gas different from ambient air and a gas supply system that couples the at least one gas source to the mask apparatus, the gas supply system supplying the stored gas to the chamber of the body. In certain of the above embodiments, the gas provided by the oxygen source includes an increased concentration of oxygen that is greater than the environmental concentration of oxygen in ambient air.

[0072] Although the mask device 301 has been described above in connection with a crosslinking treatment, the mask device 301 can additionally or alternatively be used to provide other treatments for the eyes 1 a, b. By way of example, the mask device 301 can be employed for antimicrobial treatment. Indeed, the mask device 301 can also apply and photoactivate a photosensitizer, e.g., riboflavin, for antimicrobial effect. In other antimicrobial treatments, an antibiotic agent can be applied with the applicators 332 a, b in combination with oxygen from the oxygen sources 340 a, b. Such application of an antibiotic agent can be more effective than simply applying the antibiotic agent to air. Indeed, a lower amount of antibiotic agent can be employed when a higher concentration of oxygen is provided.

[0073] As described above, according to some aspects of the present disclosure, some or all steps of the procedure described and illustrated above can be automated or guided under the control of a controller (e.g., controller 120). In general, the controller can be embodied as a combination of hardware and software elements. The hardware aspects can include a combination of operably linked hardware components including a microprocessor, logic circuitry, communication / network ports, digital filters, memory or logic circuitry. The controller can be adapted to perform operations specified by computer executable code that can be stored on a computer readable medium.

[0074] As described above, the controller can be a programmable processing device that executes software or stored instructions, such as a conventional external computer or an on-board field programmable gate array (FPGA) or digital signal processor (DSP). In general, the physical processor and / or machine employed by the embodiments of the present disclosure for any processing or evaluation can include one or more networked or non-networked general-purpose computer systems, microprocessors, field programmable gate arrays (FPGA), digital signal processors (DSP), microcontrollers, and the like, programmed according to the teachings of the exemplary embodiments of the present disclosure, as will be understood by those skilled in the computer and software arts. The physical processor and / or machine can be externally networked with the image capture device, or can be integrated so as to be intrinsic to the image capture device. Appropriate software can be readily created by a programmer of ordinary skill based on the teachings of the exemplary embodiments, as will be understood by those skilled in the software arts. In addition, the devices and subsystems of the exemplary embodiments can be embodied by the creation of application-specific integrated circuits or by interconnecting an appropriate network of conventional component circuits, as will be understood by those skilled in the electrical arts. Thus, example implementations are not limited to any specific combination of hardware circuitry and / or software.

[0075] Stored on any one or combination of computer readable media, the exemplary embodiments of the present disclosure can include software and the like that controls the devices and subsystems of the exemplary embodiments, operates the devices and subsystems of the exemplary embodiments, and enables the devices and subsystems of the exemplary embodiments to interact with a human user. Such software can include, but is not limited to, device drivers, firmware, operating systems, development tools, application software, and the like. Such computer readable media can further include computer program products of the embodiments of the present disclosure for performing all or a portion (if processing is distributed) of the processing performed in the embodiments. The computer code devices of the exemplary embodiments of the present disclosure can include any suitable interpretable or executable code mechanisms, including but not limited to scripts, interpretable programs, dynamic link libraries (DLLs), Java classes and applets, complete executable programs, and the like. Furthermore, portions of the processing of the exemplary embodiments of the present disclosure can be distributed for better performance, reliability, cost, and the like.

[0076] Common forms of computer readable media can include, by way of example, a floppy disk, a flexible disk, a hard disk, a magnetic tape, any other suitable magnetic medium, a CD-ROM, a CDRW, a DVD, any other suitable optical medium, punch cards, paper tape, optical mark sheets, any other suitable physical medium with holes or other optically recognizable indicia patterns, RAM, PROM, EPROM, FLASH-EPROM, any other suitable memory chip or cartridge, a carrier wave, or any other suitable medium from which a computer can read.

[0077] While the present disclosure has been described with reference to one or more specific embodiments, those skilled in the art will recognize that many modifications may be made without departing from the spirit and scope of the present disclosure. Each of these embodiments and their obvious variations are contemplated as being within the spirit and scope of the present disclosure. It is contemplated that additional embodiments according to aspects of the present disclosure may combine any number of features from any of the embodiments described herein.

Claims

1. 1. A system for treating an eye, comprising: the mask device includes a front side and a rear side; The rear side is configured to be positioned close to the face, The front side is configured to be positioned distally from the face; the mask device includes an outer wall extending between at least a front side and a rear side; an outer wall defining a chamber extending between the first and second eyes; the chamber includes a first section and a second section; the first section is configured to be positioned over the first eye; the second section is configured to be positioned over the second eye; the front side includes a first transmissive region disposed over the first section and a second transmissive region disposed over the second section; a first transparent region for allowing a first photoactivating light for a first eye to be delivered to the first section; A second transparent area allows a second photoactivating light for a second eye to be delivered to the second section. a mask device configured to be positioned on a face over the first and second eyes; at least one gas source storing a gas different from ambient air; A gas supply system connecting at least one gas source to the mask apparatus, the gas supply system configured to supply a stored gas to a chamber of the mask apparatus.

2. 2. The system of claim 1, wherein the gas comprises an increased concentration of oxygen that is greater than the ambient concentration of oxygen in the surrounding air.

3. 2. The system of claim 1, wherein the gas supply system comprises a first port leading to a first section of the chamber and a second port extending to a second section of the chamber.

4. At least one gas source a first gas source coupled to the mask apparatus and including a first opening that allows a first gas to flow through the first port to the first section; 4. The system of claim 3, further comprising: a second gas source coupled to the mask device and including a second opening allowing a second gas to flow through the second port into the second section.

5. The system of claim 4 , wherein the first gas and the second gas have different gas mixtures.

6. the gas supply system includes a first seal closing a first opening of the first gas source and a second seal closing a second opening of the second gas source; a first seal is configured to be disengaged to selectively allow a first gas to flow to the first section; The system of claim 4 , wherein the second seal is configured to be disengaged to selectively allow the second gas to flow to the second section.

7. the at least one gas source includes a gas source remote from the mask device; the gas supply system including a first tube extending from the first port to a gas source; a second tube extending from the second port to a gas source.

8. the mask device includes a first diffuser and a second diffuser; the first port communicates with the first diffuser; a second port leading to a second diffuser; a first diffuser configured to deliver the first gas toward a first temple of the face to minimize turbulence or back pressure of the first gas flowing through the first section; 4. The system of claim 3, wherein the second diffuser is configured to deliver the second gas toward a second temple of the face to minimize turbulence or back pressure of the second gas flowing in the second section.

9. The system of claim 1 , further comprising at least one illumination device configured to provide at least one of the first photoactivating light or the second photoactivating light.

10. The system of claim 1 , wherein the first photoactivating light and the second photoactivating light are delivered according to different treatment parameters.

11. a first aperture having a first transmissive region formed on a front side thereof; The system of claim 1 , wherein the second transmissive area is a second aperture formed in the front side.

12. a first transparent region including a first window formed on a front side thereof; The system of claim 1 , wherein the second transparent area is a second window formed in the front side.

13. The system of claim 12 , wherein the mask device is configured to maintain gas from the at least one gas source at a predetermined pressure.

14. a first solution applicator coupled to the mask device and configured to deliver a first solution to the first eye; 10. The system of claim 1, further comprising: a second solution applicator coupled to the mask device and configured to deliver a second solution to a second eye.

15. 15. The system of claim 14, wherein the first solution and the second solution comprise different photosensitizer formulations.

16. The system of claim 1 , wherein gas can flow across the chamber from the first section to the second section and vice versa.

17. The system of claim 1 , wherein the mask apparatus includes an interior wall separating a first section and a second section of the chamber of the mask apparatus.

18. 1. A method for treating an eye, comprising: the mask device includes a front side and a rear side; The rear side is configured to be positioned close to the face, The front side is configured to be positioned distally from the face; the mask device includes an outer wall extending between at least a front side and a rear side; an outer wall defining a chamber extending between the first and second eyes; the chamber includes a first section and a second section; the first section is configured to be positioned over the first eye; the second section is configured to be positioned over the second eye; the front side includes a first transmissive region disposed over the first section and a second transmissive region disposed over the second section; positioning a mask device on a face over the first and second eyes; at least one of delivering a first photoactivating light to a first eye through a first transparent region or delivering a second photoactivating light to a second eye through a second transparent region; and supplying a gas, different from ambient air, to a chamber of the mask apparatus from at least one gas source coupled to the mask apparatus via a gas supply system.

19. 20. The method of claim 18, further comprising at least one of the steps of delivering a first photosensitizer solution to a first eye according to a first soaking time or delivering a second photosensitizer solution to a second eye according to a second soaking time.

20. 20. The method of claim 19, wherein the first photosensitizer solution and the second photosensitizer solution have different photosensitizer formulations.

21. A first photosensitizer solution is first delivered to a first eye; after the first photosensitizer solution is delivered according to the first soaking time, a first photoactivating light is delivered by the illumination device to the first eye; a second photosensitizer solution is delivered to the second eye during delivery of the first photoactivating light to the first eye; 20. The method of claim 19, wherein a first photoactivating light is delivered to a first eye and a second photosensitizer solution is delivered according to a second soaking time, after which a second photoactivating light is delivered to a second eye by the same lighting device.

22. 20. The method of claim 18, wherein the gas comprises an increased concentration of oxygen that is greater than the ambient concentration of oxygen in ambient air.

23. The at least one gas source includes a first gas source and a second gas source, and the step of supplying gas from the at least one gas source includes: supplying a first gas from a first gas source to a first section through a first port of the mask device; 20. The method of claim 18, further comprising the step of: supplying a second gas from a second gas source to the second section through a second port of the mask device.

24. 24. The method of claim 23, wherein the first gas and the second gas have different gas mixtures.

25. the gas supply system including a first seal closing a first opening of the first gas source and a second seal closing a second opening of the second gas source; providing the first gas includes displacing a first seal to allow the first gas to flow to the first section; 24. The method of claim 23, wherein the step of supplying the second gas comprises the step of displacing a second seal to allow the second gas to flow to the second section.

26. 20. The method of claim 18, wherein the gas is delivered toward the temples of the face to minimize turbulence in the gas flowing into the chamber.

27. 20. The method of claim 18, wherein the first photoactivating light and the second photoactivating light are provided according to substantially different illumination parameters.

28. a first photoactivating light is delivered to the first eye by a first illuminator; a second photoactivating light is delivered to the second eye by a second illumination device; 20. The method of claim 18, wherein at least a portion of the application of the first photoactivating light occurs during at least a portion of the application of the second photoactivating light.

Images