# Patent

## Title
Eye coloring systems

## Abstract

A novel system for coloring tissues of the human eye, especially methods of coloring the iris, includes drying the tissue surface, applying colorant to the dried surface, and then drying the applied colorant. The system avoids tattooing, implanting, and corneal modification. Permanent results may be obtained. Colorants may be coatings or stains.

## Background
RELATED APPLICATIONS
This application is a continuation-in-part of U.S. patent application Ser. No. 12/167,946 filed Jul. 3, 2008 by the same inventor.


FIELD OF THE INVENTION
The present invention relates to systems (methods, apparatuses, and their relationships) for changing the color of the eye, perhaps permanently, for cosmetic purposes. It is not related to tattooing or to implants, nor to modifications of the cornea.
BACKGROUND OF THE INVENTION
The human eye is a generally spherical structure, or eyeball, of a living tissue called “sclera,” which is normally white. An opening in the front of the eye, called a pupil, permits entry of light into the eyeball, through the lens of the eye and onto the retina. The size of the pupil is controlled by an iris, which has a natural color. When reference to a person's eye color is made in day-to-day conversation, it is normally the color of the iris that is referred to. In front of the pupil and iris is the cornea.
An attempt at eye coloration that was widely reported involved eye tattooing, in which, with some 40 needle pricks, a blue ink was introduced into the subconjunctival space of the eye for purposes of body ornamentation. The methodology was dangerous and the results are still not completely known. That is, reports of whether or not the eye tattoo volunteer went blind are pending.
U.S. Pat. No. 5,793,466 was issued to Moncada on Aug. 11, 1998 for an EYE COLOR HIGHLIGHTING CONTACT LENS that features a contact lens with patterns of colored radial lines outside a central clear circular area. The contact lens is removable.
Several patents have been issued for surgical contrast coloration methods that assist the surgeon in visualizing tissues of eye. U.S. Pat. No. 6,306,127 was issued to Homer on Oct. 23, 2001 for a METHOD OF ALTERATION OF IRIS PIGMENTATION that features using laser beams of various frequencies to destroy selected pigments in the iris and thereby change the color of the iris. U.S. Pat. No. 6,692,526 was issued to Snyder, et al., on Feb. 17, 2004 for a OPHTHALMOLOGICAL SURGERY COLORANT AND DELIVERY SYSTEM that features the use of a temporary, selectively administered, contrast stain in retinal and cataract surgery to aid the surgeon in distinguishing various tissues of the eye. U.S. Pat. No. 6,367,480 issued to Coroneo on Apr. 9, 2002 for METHODS FOR VISUALIZING THE ANTERIOR LENS CAPSULE OF THE HUMAN EYE features use of trypan blue for enhanced visualization of the anterior lens capsule during cataract surgery. U.S. Pat. No. 6,372.449 issued to Coroneo on Apr. 16, 2002 for OPHTHALMIC METHODS AND USES features the use of trypan blue to identify membranes and structures within the eye. U.S. Pat. No. 6,533,769 issued to Holmen on Mar. 18, 2003 for METHOD FOR USE IN CATARACT SURGERY features the use of active agents to destroy epithelial cells during cataract surgery and provides for a dye accompanying the active agents to assist the surgeon in visualizing the active agents during introduction and subsequent removal of the active agents and the dye. The existing surgical methods are primarily focused on enhancing the surgeon's ability of visualize the tissues, are short term methods, and are not directed towards cosmetic surgery. Colored implants are known in eye surgery (see US20060036318 A1 to Foulkes published Feb. 16, 2006 and U.S. Pat. No. 7,037,337 B2 to Carriazo May 2, 2006). Staining a cornea in a healthy eye is also known (WO1995003017 to Robbins, et al., published Feb. 2, 1995). Surgical contrast staining is discussed in medical literature, such as Jacobs, et al., “Capsule Staining as an Adjunct to Cataract Surgery” Ophthalmology, Volume 113, Number 4, April 2006.
The inventor, an ophthalmologic surgeon, has recognized a need for an improved cosmetic eye coloring system that does not introduce the risks of eye tattooing, implanting, or corneal modification. In order to meet those needs, and to solve related problems, the inventor has developed the novel eye coloring system of the present invention.
OBJECTS AND FEATURES OF THE INVENTION
A primary object and feature of the present invention is to provide an eye coloring system that will be safe. A further primary object and feature of the present invention is to provide such a system that enables coloring of the sclera, the surfaces of the conjunctiva, the anterior surface of the iris, as well as the safe coloring of the subconjunctival space. A further primary object and feature of the present invention is to provide such a system that does not include lasers, implants, or corneal modification. Other objects and features of this invention will become apparent with reference to the following descriptions.
SUMMARY OF THE INVENTION
In accordance with a preferred embodiment hereof, this invention provides A method for coloring of a surface of an eye tissue including the steps of: drying the surface of such eye tissue to be colored; applying a colorant to at least a portion of the dried surface of such eye tissue to be colored; and drying the colorant on the at least the portion of the dried surface of such eye tissue to be colored. The method, further including a step of distributing the colorant in a predetermined pattern when applying the colorant. The method, further including the step of applying a plurality of colorants after the step of applying the colorant. The method, further including predecessor steps of: anesthetizing such eye with at least one of a topical anesthetic, a retro bulbar anesthesia, and a peribulbar anesthesia; securing such eyelids in a spaced-apart relationship using an eyelid speculum; and providing additional magnification of a portion of such eye tissue to be colored. The method, where the eye tissue to be colored includes an iris, the method further including further predecessor steps of: constricting a pupil of such eye using one of a pre-operative miotic and an intra-operative miotic; making first and second incisions into the anterior chamber of such eye on opposite sides of the cornea of such eye; removing residual aqueous from the angle of the anterior chamber proximate such edge of such pupil using a cannula, while avoiding damage to other intraocular structures; and inflating such anterior chamber with a blowing gas. The method, further including successor steps of: exchanging the blowing gas with balanced salt solution; providing intraocular pressure in the physiologic range; applying at least one of antibiotic and anti-inflammatory drops to such eye; and removing the eyelid speculum. The method, where the step of providing intraocular pressure is accomplished with a single cannula. The method, where the step of exchanging the blowing gas with balanced salt solution is accomplished with a single cannula. The method, further including successor steps of: applying at least one of antibiotic and anti-inflammatory drops to such eye; and removing the eyelid speculum. The method, where the colorant is sterile. The method, where the coloring is a sterile procedure.
A method of coloring an iris including the steps of: accessing such iris; drying a portion of such iris of such eye by concurrently infusing a blowing gas and aspirating the blowing gas at a rate the maintains inflation of such eye but does not over-inflate such eye; applying colorant to such iris of such eye; drying the applied colorant; closing the access to such iris. The method of coloring an iris, where concurrently infusing a blowing gas and aspirating the blowing gas is accomplished with a single cannula. The method of coloring an iris, where the step of accessing such iris includes: anesthetizing such eye with at least one of a topical anesthetic, a retro bulbar anesthesia, and a peribulbar anesthesia; securing such eyelids in a spaced-apart relationship using an eyelid speculum; providing additional magnification of a portion of such iris to be colored; constricting the pupil of such eye using one of a pre-operative miotic and an intra-operative miotic; making first and second incisions into the anterior chamber of such eye on opposite sides of the cornea of such eye; and removing residual aqueous from the angle of the anterior chamber proximate such edge of such pupil using a cannula, while avoiding damage to other intraocular structures. The method of coloring an iris where the concurrently infusing a blowing gas and aspirating the blowing gas is accomplished with a single cannula through one of the first incision and the second incision. The method of coloring an iris, where the step of closing such access to such iris includes the steps of: exchanging the blowing gas with balanced salt solution; providing intraocular pressure in the physiologic range; applying at least one of antibiotic and anti-inflammatory drops to such eye; and removing the eyelid speculum.
A method of coloring the iris including the steps of: anesthetizing such eye with at least one of a topical anesthetic, a retro bulbar anesthesia, and a peribulbar anesthesia; securing such eyelids in a spaced-apart relationship using an eyelid speculum; providing additional magnification of a portion of such iris to be colored; constricting the pupil of such eye using one of a pre-operative miotic and an intra-operative miotic; making first and second incisions into the anterior chamber of such eye on opposite sides of the cornea of such eye; removing residual aqueous from the angle of the anterior chamber proximate such edge of such pupil using a cannula, while avoiding damage to other intraocular structures; drying a portion of such iris of such eye by concurrently infusing a blowing gas and aspirating the blowing gas at a rate the maintains inflation of such eye but does not over-inflate such eye; applying colorant to such iris of such eye; drying the applied colorant; exchanging the blowing gas with balanced salt solution; providing intraocular pressure in the physiologic range; applying antibiotic or anti-inflammatory drops to such eye; removing the eyelid speculum. The method, where the step of accessing such iris includes inflation of a space between such iris and an anterior chamber. The method, where the inflation uses a mixture of gases. The method, where the concurrently infusing a blowing gas and aspirating the blowing gas is accomplished with a single cannula through one of the first incision and the second incision.



BRIEF DESCRIPTION OF THE DRAWINGS
The above and other objects and advantages of the present invention will become more apparent from the following description taken in conjunction with the following drawings in which:
FIG. 1 shows a side elevation cross-sectional view illustrating relevant portions of an eye as a reference;
FIG. 2 shows a process flow diagram illustrating an improved eye-coloring system, according to a preferred embodiment of the present invention;
FIG. 3 shows a process flow diagram illustrating an exemplary method of coloring the external surface of the conjunctiva as part of an improved eye-coloring system, according to a preferred embodiment of the present invention;
FIG. 4 shows a process flow diagram illustrating an exemplary method of suspending colorant in the subconjunctival space as part of an improved eye-coloring system, according to a preferred embodiment of the present invention;
FIG. 5 shows a process flow diagram illustrating an exemplary method of coloring the sclera as part of an improved eye-coloring system, according to a preferred embodiment of the present invention;
FIG. 6 shows a process flow diagram illustrating an exemplary method of coloring the iris as part of an improved eye-coloring system, according to a preferred embodiment of the present invention;
FIG. 7 shows a process flow diagram illustrating an exemplary general method of coloring a surface of the eye as part of an improved eye-coloring system, according to a preferred embodiment of the present invention; and
FIG. 8 shows a process flow diagram illustrating an exemplary method of coloring the internal surface of the conjunctiva as part of an improved eye-coloring system, according to a preferred embodiment of the present invention.



DETAILED DESCRIPTION OF THE BEST MODES AND PREFERRED EMBODIMENTS OF THE INVENTION
FIG. 1 shows a side elevation cross-sectional view illustrating relevant portions of an eye 100 as a reference. The front of the eye 100 is surrounded by the conjunctiva 102, which covers the cornea 108 and the sclera 104. Between the conjunctiva 102 and the sclera 104 or cornea 108 is the subconjunctival space 103. Normally, the subconjunctival space 103 is very narrow and contains a thin layer of fluid. Behind the cornea 108 lies the anterior chamber 110, normally filled with an aqueous humour. The iris 112 is a sphincter surrounding the pupil 118. The iris 112 regulates the amount of light that moves through the pupil 118 to the lens 114. Lens 114 is encapsulated and the capsule is suspended in place by the suspensory ligaments 116. The suspensory ligaments 116 and the iris 112 are maintained in position by the ciliary body 120. The posterior chamber 122 is located behind the iris 112. Just beyond the cornea 108 and near the ciliary body 120 is the trabecular meshwork 124.
FIG. 2 shows a process flow diagram illustrating an improved eye-coloring system 200, according to a preferred embodiment of the present invention. The step 202 includes providing necessary materials and instruments for the following steps. Depending on the method 300, 400, 500, 600, or 800 to be followed, the following materials and instruments may be needed: topical anesthetic eye drops; injectable ophthalmic anesthesia; intraocular miotic; pilocarpine eye drops; antibiotic eye drops; anti-inflammatory eye drops; cotton tip applicators; ophthalmic operating microscope; surgical loupes; eyelid speculum; ocular sponges; sterile gauzes; compressed gas, commercially available tank or handheld can; coloring agents, various types; paint brush; ophthalmic lacrimal probe(s); syringes; needles, various sizes; ocular cannulas, various sizes; ophthalmic scissors; ophthalmic forceps; ophthalmic sutures, various sizes and materials; ophthalmic cautery, various kinds; surgical glue; sterile ophthalmic drape; cataract removal machine (phacoemulsification (“phaco”) machine); sterile tubing for above machine; infusion/aspiration probe for above machine; and balanced salt solution. Following step 202, any one particular step 300, 400, 500, 600, or 800, or any combination of two or more of steps 300, 400, 500, 600, or 800, may be performed. Each of these steps 300, 400, 500, 600, or 800 will be described in more detail below. Step 700 is a generalization of the surface-coloring steps 300, 500, 600, and 800. Some inadvertent surface coloring may occur in step 400. Surface coloring may include surface coating. Step 204 includes equipment cleaning, disposal of surgical waste, putting away unused portions of colorant, and other steps needed to secure the medical facility and provide post-surgical care for the patient.
FIG. 3 shows a process flow diagram illustrating an exemplary method 300 of coloring the external surface of the conjunctiva 102 as part of an improved eye-coloring system 200, according to a preferred embodiment of the present invention. Step 302 includes identification of the area of the external surface of the conjunctiva 102 to be colored, selection of any pattern that may be used, and selection of the colors to be used. Step 302 may also include testing for allergic reaction to any of the colorants selected. In step 304, the eye 100 is anesthetized in ways known in the art of ophthalmic surgery. Minimally intrusive anesthetic methods are preferred, but consideration of patient allergies and sensitivities is also important. Preferably, a topical anesthetic, such as tetracaine 1% is used in step 304. A deeper anesthesia may be developed by soaking a cotton-tipped applicator and then placing the soaked swab in contact with the conjunctiva 102 for a time. In step 306, the eyelids are secured in an open, or spaced apart, position using an eyelid speculum.
The selected portion of the surface of the conjunctiva 102 is dried in step 308, using a sponge or blown dry gas. The dry gas may be a single gas, such as nitrogen, or a mixture of gasses, such as air. In step 310, sterile colorant is applied to the dried external surface of the conjunctiva 102. Application of the sterile colorant may be by any type of applicator including, without limitation, droppers, swabs, brushes, pens, and sprayers. A stencil may be used during step 310. Colorants, because they are being introduced to the eye 100, are preferably sterile. In step 312, the colorant is dried on the external surface of the conjunctiva 102. Step 312 may include removing excess colorant by sponge and then using blown dry gas to dry the colorant. Once the colorant has dried 312, the eyelids are released by removal of the eyelid speculum in step 314. Antibiotic and/or anti-inflammatory drops may be given in step 316 either after the eyelid speculum is removed, as shown, or before the eyelid speculum is removed. Step 318 may include a period of observation for any sensitivity, and verification that eyesight has not been impaired.
Those of skill in the art, enlightened by the present disclosure, will appreciate that various colorants may be applied to various portions of the external surface of the conjunctiva 102 to form patterns. Likewise, those of skill in the art, enlightened by the present disclosure, will appreciate that the colorants may be permanent, such as inks used in tattooing, or temporary, such as food coloring.
The method 300 of the present invention is novel as compared to eye tattooing, in that it requires no penetrations of the conjunctiva 102. The method 300 of the present invention is novel as compared to surgical contrast dying in that method 300 may be permanent and is cosmetic.
FIG. 4 shows a process flow diagram illustrating an exemplary method 400 of suspending colorant in the subconjunctival space 103 as part of an improved eye-coloring system 200, according to a preferred embodiment of the present invention. Step 402 includes identification of the area of the external surface of the conjunctiva 102 to be colored, selection of any pattern that may be used, and selection of the colors to be used. Step 402 may also include testing for allergic reaction to any of the colorants selected. In step 304, the eye 100 is anesthetized in ways described above. In step 306, the eyelids are secured in an open position using an eyelid speculum. In step 404, the sterile colorant solution is prepared by, for example, dilution with a balanced salt solution to achieve the desired color saturation. The prepared colorant is drawn into a syringe in step 406 having an approximately 30-gauge needle and slowly injected into the subconjunctival space 103 at a single site in step 408. While the colorant is being injected, pressure is applied 410 with a cotton-tipped applicator or equivalent, to pressure the prepared colorant solution to move within the subconjunctival space 103 to spread the colorant solution completely through the subconjunctival space 103 or to form a pattern in the subconjunctival space 103. The steps 404, 406, 408, and 410 may be repeated for various colors in the course of one step 400. Once the colorant has been positioned, the eyelids are released by removal of the eyelid speculum in step 314. Antibiotic and/or anti-inflammatory drops may be given in step 316 either after the eyelid speculum is removed, as shown, or before the eyelid speculum is removed. Step 412 may include a period of observation for any sensitivity, and verification that eyesight has not been impaired. Subconjunctival space 103 is an intraocular space.
Those of skill in the art will appreciate that suspending colorant in the subconjunctival space 103 may cause coloration of the internal surface of the conjunctiva 102 and of the outer surface of the sclera 104. If the colorant used contains various pigments that are taken up differentially by the internal surface of the conjunctiva 102 and the outer surface of the sclera 104, interesting results may be obtained. In a particular embodiment of the method, a first colored pattern may be established in the subconjunctival space 103 as a background, and a second colored pattern may be established on the external surface of the conjunctiva 102 as a foreground image, with the combination producing striking results. For example, and without limitation, a sun-ray pattern in gold, with smooth reflective particles in the gold colorant may be established in the subconjunctival space 103 and a pale blue colorant may be established on the external surface of the conjunctiva 102, creating one visual effect (from the perspective of another) in bright light and another visual effect in dim light. Those of skill in the art of color overlays, enlightened by this disclosure, will appreciate the vast number of overlay patterns that may be achieved on the human eye 100.
The method 400 of the present invention is novel as compared to eye tattooing, in that it requires only one needle insertion for each colored area, and not the 40 needle insertions used in tattooing. The method 400 of the present invention is novel as compared to surgical contrast dying in that method 400 may be permanent and is cosmetic.
FIG. 5 shows a process flow diagram illustrating an exemplary method 500 of coloring the sclera 104 as part of an improved eye-coloring system 200, according to a preferred embodiment of the present invention. Step 502 includes identification of the area of the external surface of the sclera 104 to be colored, selection of any pattern that may be used, and selection of the colors to be used. Step 502 may also include testing for allergic reaction to any of the colorants selected. In step 304, the eye 100 is anesthetized in ways described above. In some embodiments, standard retro bulbar or peribulbar anesthesia may be used similar to other eye surgeries. In step 306, the eyelids are secured in an open position using an eyelid speculum. In step 504, the physician employs a surgical microscope to more precisely observe steps 506, 508, 509, 312, and 510. In step 506, the conjunctiva 102 is dissected to expose the portion of the surface of the sclera 104 to be colored. Step 506 may be accomplished using Westcot scissors with forceps or equivalent surgical technique. In step 508, the surface of the sclera 104 to be colored is dried, using a sponge or blown dry gas. In step 509, sterile colorant is applied to the dried surface of the sclera 104 and then the colorant is dried in step 312, as discussed more fully above. After the colorant has dried 509, the conjunctiva 102 is closed 510 over the site or sites using standard ophthalmic techniques, such as suturing, cautery, medical glue, and the like. Once the conjunctiva 102 has been closed 510, the eyelids are released by removal of the eyelid speculum in step 314. Antibiotic and/or anti-inflammatory drops may be given in step 316 either after the eyelid speculum is removed, as shown, or before the eyelid speculum is removed 314. Step 512 includes all steps necessary to verify the finished procedure and to secure the surgical environment. A colorant may be a stain or a surface coating.
Those of skill in the art, enlightened by the present invention, will appreciate the vast number of combinations of techniques that may be employed. For example, and without limitation, a colored background or pattern may be first established on the sclera 104 using method 500. After the sclera 104 has healed, a colorant that is at least partially transparent but which contains smooth reflective particles may be suspended in the subconjunctival space 103 using method 400, and a colored pattern may be established on the front surface of the conjunctiva 102 to provide a decorative cosmetic effect.
The method 500 is novel as compared to eye tattooing because the method of coloring the sclera 500 disclosed herein does not require penetration of the sclera 108.
FIG. 6 shows a process flow diagram illustrating an exemplary method 600 of coloring the iris 112 as part of an improved eye-coloring system 200, according to a preferred embodiment of the present invention. Step 602 includes identification of the area of the external surface of the iris 112 to be colored, selection of any pattern that may be used, and selection of the colors to be used. Step 602 may also include testing for allergic reaction to any of the colorants selected. In step 304, the eye 100 is anesthetized in ways discussed above, including standard retro bulbar or peribulbar anesthesia. In step 306, the eyelids are secured in an open position using an eyelid speculum. In step 604, a surgical microscope or surgical loupe is used to provide magnification. In step 606, the pupil 118 is constricted. Preferably, the pupil 118 is constricted pre-operatively with pilocarpine drops. In an alternative embodiment of the method 600, an interoperative miotic, such as Miochol is used for step 606. In step 608, first and second incisions are made into the anterior chamber 110 on opposite sides of the cornea 108. An air bubble or dry gas is injected into the anterior chamber 110 to displace the aqueous humour, which is removed 610 from the angle of the anterior chamber 110 and near the edge of pupil 118 using a small gauge cannula. Care is exercised to avoid damage to other intraocular structures such as the lens 114, the cornea 108, and trabecular meshwork 124. Anterior chamber 110 is an intraocular space.
In step 612, the anterior chamber 110 is inflated with blown gas that is infused and aspirated to maintain a constant but not distending inflation of the anterior chamber 110. A single infusion/aspiration (I/A) cannula is preferred. In other embodiments, a two-cannula approach (one for infusion, the other for aspiration) may be used.
In step 613, the surface of the iris 112 is dried. To accomplish drying 613 of the iris 112, a probe, or cannula, similar to those used to infuse and aspirate fluid in cataract surgery, is used to infuse dry gas into the anterior chamber 110 and to aspirate the dry gas at the same time. The flow rates of infusion and aspiration are regulated to maintain inflation of the anterior chamber 110. A phaco machine, known in the art of ophthalmic surgery, is used to provide concurrent infusion and aspiration of gas with a single cannula in either incision. In another embodiment, the supply of dry gas may come from a commercially available tank, through a regulator coupled to the tank. In an alternate embodiment, two cannula may be used through said first and second incisions. Standard tubing may be used to connect the gas supply to the probe in the eye 100. Over-inflation of the anterior chamber 110, as well as under inflation of the anterior chamber 110, is to be avoided. The probe is manipulated with one hand to aim the blowing dry gas onto the surface to be colored and, thereby, to dry that surface. The drying 613 is done only to the extent that is required, in the physician's judgment, to limit the colorant from running when applied 614 to the surface. Drying 613 should not desiccate or damage the iris 112.
A colorant may be a stain or a surface coating.
In step 614, the colorant is applied to at least a portion of the dried surface of the iris 112. Preferably, a probe (for example, a lacrimal probe) is held in the surgeon's other hand and used to apply 614 the sterile colorant to the surface of the iris 112. In various other embodiments, various types of probes that are operable to apply sterile colorant to the surface of the iris may be used. The gas infusion probe is used to dry the colorant, in step 616, immediately after it is applied. The drying of the colorant 616 is done only to the extent that is required, in the physician's judgment, to limit the colorant from running when the anterior chamber is filled 618 with balanced salt solution. Once the colorant is applied and dried, the probe is removed. The gas in the eye 100 is gently exchanged 618 with balanced salt solution to maintain inflation of the anterior chamber 110, preferably using a single cannula. The intraocular pressure is maintained 620 and finally established in the correct physiologic range, preferably with a single cannula. In step 622 antibiotic and/or anti-inflammatory drops are placed on the eye 100, and the eyelids are released in step 624 by removing the eyelid speculum.
Those of skill in the art, enlightened by the present invention, will appreciate the coloring and patterning schemes that may be used on an iris 112, and many practical, as well as decoratively cosmetic, purposes for this invention. Those of skill in the art, enlightened by the present invention, will appreciate that the infusion and aspiration technique described for coloring the iris 112 is an alternate technique for coloring the inside surface of the conjunctiva 102 and/or the outside surface of the sclera 104, by inflating the subconjunctival space 103 and applying colorant to the interior of the inflated area.
Steps 304 and 306 are generic predecessor steps to various eye-coloring methods 300, 400, 500, 600, 700, and 800. Step 604 may be used in other methods 300, 400, 500, 700, and 800, as needed. Steps 606, 608, 610 and 612 are specific predecessor steps to coloring the iris 600. Steps 613, 614, and 616 are essential steps for the coloring the iris 600 and, in generic form, are essential to eye coloring methods 300, 500, 600, 700, and 800. Steps 618 and 620 are successor steps specific to coloring the iris 600. Steps 622 and 624 are successor steps generic to multiple eye-coloring methods 300, 400, 500, 600, 700, and 800.
Method 600 is novel as compared to eye tattooing because the method of coloring iris 600 disclosed herein does not require penetration of the iris 112.
FIG. 7 shows a process flow diagram illustrating an exemplary general method 700 of coloring a surface of the eye 100 as part of an improved eye-coloring system 200, according to a preferred embodiment of the present invention. The coloration of any eye surface begins with preparatory step 702, which subsumes the preparatory steps 302, 502, 602, and 802. Steps 304 perform the same function throughout, although there are different specific techniques for different levels of invasiveness of the procedure. Steps 306 are the same throughout, although none require any particular model or type of eyelid speculum. Each method 300, 400, 500, 600, and 800 requires gaining surgical access 704 to the surface to be colored. The complexity of this step varies with the method 300, 400, 500, 600, or 800, but all methods require gaining access 704. In each method 300, 500, 600, and 800, the surface to be colored must be dried 706. In method 400, a portion of the colorant may adhere to the interior surface of the conjunctiva 102 and to the outer surface of the sclera 104. In any event, the facing surfaces of the sclera 104 and conjunctiva 102 are accessed in method 400 even if only to create the subconjunctival space 103 that holds the colorant. Step 706 subsumes various drying techniques, including those described above relating to steps 308, 508, 612, and 804 such as blown gas, sponge, or blotter techniques. Step 706 is not used in method 400. Step 708 subsumes steps 310 (used in method 300, 500, and 800) and 614, as well as various additional application techniques appropriate to this invention. Step 710 subsumes steps 312 (used in method 300, 500, and 800) and 616, as well as various additional colorant drying techniques appropriate to this invention. In step 712, access to the surface is closed. Step 712 subsumes steps 314, 510, 618 & 620, and 806, as well as various additional closure techniques appropriate to this invention. Step 316 performs the same function throughout methods 300, 400, 500, 600, and 800, although the particular type, composition, and concentration of antibiotic drops or anti-inflammatory drops may vary. Step 314 performs the same function throughout methods 300, 400, 500, 600, and 800. Step 710 has the same function as steps 318, 412, 512, 626, and 804, although the particulars may vary.
Method 700 is novel as compared to eye tattooing because the colorant is applied to a surface, rather than injected.
FIG. 8 shows a process flow diagram illustrating an exemplary method 800 of coloring the internal surface of the conjunctiva 102 as part of an improved eye-coloring system 200, according to a preferred embodiment of the present invention. Preparatory step 802 is similar to the preparations in step 502, with the possible exception of the selection of colorant type. Steps 304 and 306 are discussed above under method 500. In step 504, magnification is provided for improving visualization of the site. In step 506, the conjunctiva 102 is dissected and laid open to show its underside. The surface of the underside of the conjunctiva 102 is dried, in step 804, using blown dry gas or a sponge. In step 805, sterile colorant is applied to the interior, or underside, surface of the conjunctiva 102. The colorant is then dried in step 312, using gently blown dry gas and optionally, a sponge or blotter. The conjunctiva 102 is closed in step 806, using known surgical closures. Steps 314 and step 316 are as previously described. The method ends with step 808, which may include verification of the patient's eyesight and securing the surgical environment. A colorant may be a stain or a surface coating.
Method 800 is an improvement over eye tattooing because it enables coloring only the interior surface of the conjunctiva 102 and does not require 40 needle insertions.
All of the methods 300, 400, 500, 600, 700, and 800 are improvements over surgical contrast coloring because surgical contrast coloring is not permanent, patterned, or cosmetic. All of the methods 300, 400, 500, 600, 700, and 800 are distinct from tattooing an ossified cornea 108, because the methods 300, 400, 500, 600, 700, and 800 can be used on eyes 100 that are not blind and do not modify the cornea 108. All of the methods 300, 400, 500, 600, 700, and 800 are preferably sterile procedures and are steps of improved eye-coloring system 200. The steps of each method 300, 400, 500, 600, 700, and 800 are preferably used in combination and in order to achieve the desired results. Each method 300, 400, 500, 600, 700, and 800 engages colorant on natural surfaces of the eye 100 and none require destruction or removal of eye tissues.
Although the present inventor has described his preferred embodiments of this invention, it will be understood that the broadest scope of this invention includes modifications such as variations in the patterns and colors as well as some variation in ophthalmic surgical equipment and supplies. For example, and without limitation, the teachings of this disclosure may be applied to mammalian eyes generally. Likewise, the teachings of this disclosure may be applied for cosmetic surgery to recover normal appearance lost to accident or diseases of the eye. Further, the teachings of this disclosure may be applied to identification markings, such as may be colored onto the conjunctiva 102 inside the lower eyelid. Such scope is limited only by the below claims as read in connection with the above specification. Further, many other advantages of applicant's invention will be apparent to those skilled in the art from the above descriptions and the below claims.

## Claims

1. A method of coloring an iris comprising the steps of:
a. accessing such iris;
b. drying a portion of such iris of such eye by concurrently infusing a blowing gas and aspirating said blowing gas at a rate the maintains inflation of such eye but does not over-inflate such eye;
c. applying colorant to said dried portion of such iris of such eye;
d. drying said applied colorant; and
e. closing said access to such iris.

2. The method of coloring an iris of claim 1, wherein said concurrently infusing a blowing gas and aspirating said blowing gas is accomplished with a single cannula.

3. The method of coloring an iris of claim 1, wherein said step of accessing such iris comprises:
a. anesthetizing such eye with at least one of a topical anesthetic, a retro bulbar anesthesia, and a peribulbar anesthesia;
b. securing such eyelids in a spaced-apart relationship using an eyelid speculum;
c. providing additional magnification of a portion of such iris to be colored;
d. constricting the pupil of such eye using one of a pre-operative miotic and an intra-operative miotic;
e. making first and second incisions into the anterior chamber of such mammalian eye on opposite sides of the cornea of such eye; and
f. removing residual aqueous from the angle of the anterior chamber proximate such edge of such pupil using a cannula, while avoiding damage to other intraocular structures.

4. The method of coloring an iris of claim 3, wherein said concurrently infusing a blowing gas and aspirating said blowing gas is accomplished with a single cannula through one of said first incision and said second incision.

5. The method of coloring an iris of claim 1, wherein said step of closing such access to such iris comprises the steps of:
a. exchanging said blowing gas with balanced salt solution;
b. providing intraocular pressure in the physiologic range;
c. applying at least one of antibiotic and anti-inflammatory drops to such eye; and
d. removing said eyelid speculum.

6. A method of coloring the iris comprising the steps of:
a. anesthetizing such eye with at least one of a topical anesthetic, a retro bulbar anesthesia, and a peribulbar anesthesia;
b. securing such eyelids in a spaced-apart relationship using an eyelid speculum;
c. providing additional magnification of a portion of such iris to be colored;
d. constricting the pupil of such eye using one of a pre-operative miotic and an intra-operative miotic;
e. making first and second incisions into the anterior chamber of such eye on opposite sides of the cornea of such eye;
f. removing residual aqueous from the angle of the anterior chamber proximate such edge of such pupil using a cannula, while avoiding damage to other intraocular structures;
g. drying a portion of such iris of such eye by concurrently infusing a blowing gas and aspirating said blowing gas at a rate the maintains inflation of such eye but does not over-inflate such eye;
h. applying colorant to said dried portion of such iris of such eye;
i. drying said applied colorant;
j. exchanging said blowing gas with balanced salt solution;
k. providing intraocular pressure in the physiologic range;
l. applying at least one of antibiotic and anti-inflammatory drops to such eye; and
m. removing said eyelid speculum.

7. The method of claim 6, wherein said step of accessing such iris comprises inflation of a space between such iris and an anterior chamber.

8. The method of claim 7, wherein said inflation uses a mixture of gases.

9. The method of claim 6, wherein said concurrently infusing a blowing gas and aspirating said blowing gas is accomplished with a single cannula through one of said first incision and said second incision.