Methods For Treating Eye Conditions With Low-level Light Therapy Patent Application (2025)

U.S. patent application number 12/204638 was filed with the patent office on 2009-03-05 for methods for treating eye conditions with low-level light therapy. Invention is credited to Jeffrey W. Jones, IOANA M. RIZOIU.

METHODS FOR TREATING EYE CONDITIONS WITH LOW-LEVEL LIGHTTHERAPY

Abstract

Architectures and techniques for treating conditions of the eye,such as presbyopia, utilize sources of treatment energy, such aselectromagnetic energy emitting devices, to implement non-cornealand other manipulations. According to these devices and methods,the sources of treatment energy are activated to direct energy ontoparts of the eye, such as the conjunctiva and sclera, to treatpresbyopia. The treatments can affect at least one property of theeye and enhance an accommodation of the eye.

 Kenton R. Mullins;Stout, Uxa, Buyan & Mullins, LLP 4 Venture, Suite 300 Irvine CA 92618 US

Related U.S. Patent Documents

Claims

1. A method for imparting a tissue treatment to an eye in need ofone or more of a physiological and a vision correction, comprising:generating low-level treatment radiation; penetrating one or moreof conjunctiva and sclera of the eye with the low-level treatmentradiation; and projecting the low-level treatment radiation ontoone or more of a sclera and a ciliary muscle of the eye, so thatthe low-level treatment radiation imparts a therapeutic treatmentaffect to but does not ablate tissue of the one or more of a scleraand a ciliary muscle, the low-level treatment radiation projectedonto one or more of the sclera and the ciliary muscle being at agreater concentration than a concentration of low-level treatmentenergy penetrating the one or more of the conjunctiva and thesclera.

2. The method as set forth in claim 1, wherein a wavelength of thetreatment energy is of a type that is more highly absorbed by atype of tissue corresponding to that of (i) the sclera or theciliary muscle than by a type of tissue corresponding to that of(ii) the conjunctiva or the sclera.

3. The method as set forth in claim 1, wherein the therapeutictreatment affect is an enhancement of one or more of anaccommodation of the eye and an elasticity of tissue of the one ormore of a sclera and a ciliary muscle.

4. The method as set forth in claim 1, and further comprisingfocusing a dose of electromagnetic radiation onto one or more ofthe sclera and the ciliary muscle of the eye, to thereby impartablative forces onto the one or more of a sclera and a ciliarymuscle.

5. The method as set forth in claim 1, wherein the projectingcomprises projecting low-level treatment radiation onto one or moreof a zonule and a lens of the eye, so that the low-level treatmentradiation imparts a therapeutic treatment affect to but does notablate tissue of the one or more of a zonule and a lens of theeye.

6. The method as set forth in claim 5, and further comprisingfocusing a dose of electromagnetic radiation onto one or more of azonule and a lens of the eye, to thereby impart ablative forcesonto the one or more of a zonule and a lens of the eye.

7. The method as set forth in claim 1, wherein the therapeuticdoses of energy comprise sonic energy.

8. The method as set forth in claim 1, wherein the therapeuticdoses of energy comprise pulsed therapeutic doses of one or more ofelectrical potential or current, sonic energy, and magnetism.

9. The method as set forth in claim 1, wherein: conjunctival tissueof the eye, which overlies the one or more of a sclera and aciliary muscle, is penetrated by the low-level treatment radiation;and the low-level treatment radiation that penetrates theconjunctival tissue is at a lower concentration than aconcentration of low-level treatment radiation projected onto theone or more of a sclera and a ciliary muscle.

10. The method as set forth in claim 9, wherein the one or more ofa sclera and a ciliary muscle is a sclera.

11. The method as set forth in claim 10, wherein a wavelength ofthe low-level treatment radiation is of a type that is more highlyabsorbed by a type of tissue corresponding to that of the sclerathan by a type of tissue corresponding to that of theconjunctiva.

12. The method as set forth in claim 9, wherein the one or more ofa sclera and a ciliary muscle is a ciliary muscle.

13. The method as set forth in claim 12, wherein a wavelength ofthe low-level treatment radiation is of a type that is more highlyabsorbed by a type of tissue corresponding to that of the ciliarymuscle than by a type of tissue corresponding to that of theconjunctiva.

14. The method as set forth in claim 1, wherein: one or more ofconjunctiva and sclera tissue of the eye, which overlies one ormore of a choroid and the ciliary muscle, is penetrated by thelow-level treatment radiation; and the one or more of conjunctivaand sclera tissue receives a lower concentration of the low-leveltreatment radiation than a concentration of the low-level treatmentradiation received by the one or more of a choroid and the ciliarymuscle.

15. The method as set forth in claim 14, wherein the one or more ofa choroid and the ciliary muscle is a choroid.

16. The method as set forth in claim 14, wherein the one or more ofa choroid and the ciliary muscle is the ciliary muscle.

17. The method as set forth in claim 1, wherein: one or more ofconjunctiva and sclera of the eye, which overlies the ciliarymuscle, is penetrated by the low-level treatment radiation; and thelow-level treatment radiation that penetrates the one or more ofconjunctiva and sclera tissue is at a lower concentration than aconcentration of low-level treatment radiation penetrating into theciliary muscle.

18. The method as set forth in claim 17, wherein a wavelength ofthe low-level treatment radiation is of a type that is more highlyabsorbed by a type of tissue corresponding to that of the ciliarymuscle than by a type of tissue corresponding to that of the one ormore of conjunctiva and sclera tissue.

19. The method as set forth in claim 17, wherein: one or more ofconjunctiva and sclera of the eye, which overlies a choroid, ispenetrated by the low-level treatment radiation; and the low-leveltreatment radiation that penetrates the one or more of conjunctivaand sclera tissue is at a lower concentration than a concentrationof treatment energy penetrating into the choroid.

20. The method as set forth in claim 19, wherein a wavelength ofthe low-level treatment radiation is of a type that is more highlyabsorbed by a type of tissue corresponding to that of choroid thanby a type of tissue corresponding to that of the one or more ofconjunctiva and sclera tissue.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. ProvisionalApplication No. 60/967,650, filed Sep. 5, 2007 and entitled METHODSFOR TREATING EYE CONDITIONS WITH LOW-LEVEL LIGHT THERAPY (Att.Docket B18047PR), the entire contents of which are herebyincorporated by reference.

[0002] This application is a continuation-in part of U.S.application Ser. No. 11/413,590, filed Apr. 26, 2006 and entitledMETHODS FOR TREATING EYE CONDITIONS (Att. Docket B19852P), theentire contents of which are hereby incorporated by reference.

BACKGROUND OF THE INVENTION

[0003] 1. Field of the Invention

[0004] The present invention relates generally to medicaltreatments and, more particularly, to methods and apparatus fortreating eye disorders such as presbyopia using energies includinginfrared laser, ultrasound and radio-frequency.

[0005] 2. Description of Related Art

[0006] Myopia and hyperopia can be treated surgically usingtechniques including corneal interventions, such as reshaping asurface curvature of the cornea located inside of the limbus area,and non-corneal manipulations, such as altering properties of thesclera (which is located outside of the limbus area), ciliarymuscle, zonules, or lens. An example of the former treatment cancomprise ablating the surface of the cornea itself to form a"multifocal" arrangement (e.g., distance vision in one eye andreading vision in another eye according to a treatment planreferred to as monovision) facilitating viewing by a patient ofboth near and far objects, and an example of the latter treatmentcan comprise introducing kerfs into portions of the sclera tothereby increase accommodation. Non-corneal interventions typicallycomprise temporarily removing or pulling-back the patient'sconjunctiva, using forceps and scissors and/or one or more ofscalpels, cautery, plasma, and laser methods, followed by theactual non-corneal manipulations (e.g., forming kerfs in thesclera). After completing the kerfs, the conjunctiva is thentypically sutured back into position.

SUMMARY OF THE INVENTION

[0007] Devices and methods of the present invention for treatingconditions of the eye, such as presbyopia, utilize sources oftreatment energy, such as electromagnetic energy emitting devices,to implement non-corneal manipulations. According to thearchitectures and techniques of the present invention, the sourcesof treatment energy can be activated to direct energy onto parts ofthe eye, such as the conjunctiva and sclera, to treat presbyopia,wherein the energy affects at least one property of the eye andresults in an enhancement in an accommodation of the eye.

[0008] The source of treatment energy can comprise a source ofelectromagnetic energy, for example, that directs energy into oneor more of the ciliary muscle and the sclera of the eye. In certainimplementations, treatment energy is directed into one or more ofthe ciliary muscle, the sclera, and zonules of the eye. Accordingto other implementations, treatment energy can be directed into oneor more of the ciliary muscle, the sclera, zonules, and the lens ofthe eye. The source of electromagnetic energy can comprise, forexample, an optical source of source of electromagnetic energy,such as a laser. In certain implementations, the laser is an Erbiumbased, pulsed laser which emits optical energy into one or more ofthe ciliary muscle and the sclera of the eye. Introduction of thetreatment energy into the sclera can increase or facilitate anincrease in accommodation of the eye, thereby mitigating theeffects of presbyopia.

[0009] While the apparatus and method has or will be described forthe sake of grammatical fluidity with functional explanations, itis to be expressly understood that the claims, unless expresslyformulated under 35 USC 112, are not to be construed as necessarilylimited in any way by the construction of "means" or "steps"limitations, but are to be accorded the full scope of the meaningand equivalents of the definition provided by the claims under thejudicial doctrine of equivalents, and in the case where the claimsare expressly formulated under 35 USC 112 are to be accorded fullstatutory equivalents under 35 USC 112.

[0010] Any feature or combination of features described herein areincluded within the scope of the present invention provided thatthe features included in any such combination are not mutuallyinconsistent as will be apparent from the context, thisspecification, and the knowledge of one skilled in the art. Inaddition, any feature or combination of features may bespecifically excluded from any embodiment of the present invention.For purposes of summarizing the present invention, certain aspects,advantages and novel features of the present invention aredescribed. Of course, it is to be understood that not necessarilyall such aspects, advantages or features will be embodied in anyparticular implementation of the present invention. Additionaladvantages and aspects of the present invention are apparent in thefollowing detailed description and claims that follow.

DETAILED DESCRIPTION OF THE INVENTION

[0011] Reference will now be made in detail to the presentlypreferred embodiments of the invention, examples of which areillustrated in the accompanying drawings. Wherever possible, thesame or similar reference numbers are used in the drawings and thedescription to refer to the same or like parts. It should be notedthat the drawings are in simplified form and are not to precisescale. In reference to the disclosure herein, for purposes ofconvenience and clarity only, directional terms, such as, top,bottom, left, right, up, down, over, above, below, beneath, rear,and front, are used with respect to the accompanying drawings. Suchdirectional terms should not be construed to limit the scope of theinvention in any manner.

[0012] Although the disclosure herein refers to certain illustratedembodiments, it is to be understood that these embodiments arepresented by way of example and not by way of limitation. Theintent of the following detailed description, although discussingexemplary embodiments, is to be construed to cover allmodifications, alternatives, and equivalents of the embodiments asmay fall within the spirit and scope of the invention as defined byany appended additional disclosure (e.g., in claims format). It isto be understood and appreciated that the process steps andstructures described or incorporated by reference herein do notcover a complete process flow for the implementations describedherein. The present invention may be practiced in conjunction withvarious medical devices that are conventionally used in the art,and only so much of the commonly practiced method steps areincluded herein as are necessary to provide an understanding of thepresent invention.

[0013] Any feature or combination of features described herein areincluded within the scope of the present invention provided thatthe features included in any such combination are not mutuallyinconsistent as will be apparent from the context, thisspecification, and the knowledge of one of ordinary skill in theart.

[0014] As used herein, "choroid" refers to the highly vascularlayer of the eye beneath the sclera.

[0015] An inability of the eye to focus sharply on nearby objects,called "presbyopia," is associated with advancing age and typicallyentails a decrease in accommodation. Introduction of treatmentenergy (e.g., laser ablation), according to any of theimplementations described herein, may increase or facilitate anincrease in accommodation, thereby mitigating effects ofpresbyopia.

[0016] In accordance with various aspects of the present invention,an accommodation can be augmented via introduction of a pluralityof "tissue treatments," meaning tissue areas contacted withtreatment energy to visibly or non-visibly affect the tissue areas,in one or more of, for example, the sclera, ciliary muscle, lens,and/or zonules.

[0017] As used herein, "sclera" refers to the outer supportingstructure or "the white" of the eye, and "ciliary muscle" refers toa muscular ring of tissue located beneath the sclera and attachedto the "lens" via "zonules."

Lens:

[0018] Regarding augmentation of accommodation via formation oftissue treatments in, for example, the lens, the lens may betreated with tissue treatments, taking care to attenuate or avoid adistortion of optical characteristics of the lens in the process.In an exemplary implementation, sizes, arrangements, depths, and/orother characteristics of tissue treatments can be adjusted so as,for example, to increase an accommodation (e.g., flexibility) ofthe lens. Following treatment, the lens may be better able tochange shape and focus. Alternative or additional tissue treatmentsmay be either similarly formed in the lens or formed using meansdifferent from that used to form the mentioned tissue treatments,in the same or different locations, at the same or other points intime, and/or with the same or different sizes.

[0019] Any of the tissue treatments may have sizes (e.g., maximumdiameters) the same as or smaller than about 1 micron and/or largerthan about 5 microns (e.g., ranging up to about 50 microns, or upto about 100 microns, or more, in certain implementations).

[0020] Low-level laser or light therapy or biostimulation of one ormore parts of the eye (e.g., the lens), further, may be performedto rejuvenate tissues thereof. In a case of the lens, anelasticity, for example, of the lens may be increased to therebyenhance an accommodation of the lens. In such instances, the lenscan be considered a target chromoform (i.e., target tissue).Generally, a wavelength of applied light energy can be aligned witha tissue type of the lens. Light wavelengths of for example, 630,690, 810 and/or 980 nm may be employed in typical embodiments.

Ciliary Muscle:

[0021] A type of low-level laser or light therapy or photo dynamictherapy (PDT) may be used, as another example, on or in a vicinityof (e.g., on tissue adjacent to) the ciliary muscle to rejuvenatethe muscle and thereby facilitate, for example, an accommodation ofthe eye. Light wavelengths of, for example, 670, 795, 819 and 980nm may be employed in certain embodiments.

[0022] Light wavelengths of, for example, 690, 810 and/or 980 nmmay be employed in typical embodiments. For a wholly or partiallynon-invasive penetration through a top layer of tissue, awavelength may be set to be absorbed less by this top layer thanthe underlying layer being treated; for example, a wavelength of630 nm may be selected to the extent that it is absorbed more bythe underlying layer to be treated (e.g., the ciliary muscle) thanby overlying layers (e.g., one or more of the conjunctiva, scleraand choroid).

[0023] A variety of light sources may be used, including low-levellasers and light-emitting diodes (LEDs). Continuous-wave (CW)energy or pulsed energy having a relatively high peak energy may beuseful in such ciliary muscle treatments. The ciliary muscle may bestimulated in some cases with, for example, CW energy gated, forexample, on for about 200 ms and off for about 200 ms. Thestimulation may restore the ciliary muscle to a relatively moreyouthful stage.

Sclera:

[0024] The above low-level applications may also be applied toscleral tissues according to modified embodiments, such as, forexample, low-level laser therapy being applied to the sclera forscleral rejuvenation. Low-level light therapy may be beneficiallyapplied to treatment of a larger portion (e.g., a relatively largeor entire area) of the sclera.

[0025] Light wavelengths of, for example, 690, 810 and/or 980 nmmay be employed in typical embodiments. For a wholly or partiallynon-invasive penetration through a top layer of tissue, awavelength may be set to be absorbed less by this top layer thanthe underlying layer being treated; for example, a wavelength of630 nm may be selected to the extent that it is absorbed more bythe underlying layer to be treated (e.g., the sclera) than by anoverlying layer (e.g., the conjunctiva).

Treatment Energies:

[0026] Treatment power densities may be relatively low, beingsimilar, for example, to power densities used in treatments of,e.g., tennis elbow, temporomandibular joint (TMJ), or tendonitis,and in representative embodiments having characteristics less thanthe following: a power density at the surface of the tissue beingtreated of about 1.47 W/cm.sup.2, a power density within the tissueof about 0.39 W/cm.sup.2, a dose of energy of about 23.6 J/cm.sup.2(for a 60 second laser exposure), and/or an energy of about 9 Jwithin and about 33.5 J at the surface of the tissue beingtreated.

Zonules:

[0027] In one implementation, a type of low-level laser or lighttherapy or photo dynamic therapy (PDT) may be used to increase anefficacy of or tighten the zonules. Zonules may be treatedendoscopically, for example, to effectively shorten their lengths.Entry may be through a peripheral corneal or limbal area using anendoscopic laser. An anterior insertion or posterior site can belased to cause a more direct effect on the ciliary body. Oneprocedure in accordance with the present invention may compriselasing the ciliary process (e.g., a portion of the ciliary musclethat connects to the zonules) in order to make the zonules moretaut. According to one embodiment, the zonules can be stained,making them a target chromoform, thereby resulting in selectivetreatment of the zonules when exposed to optical energy.

[0028] Light wavelengths of, for example, 630, 690, 810 and/or 980nm may be employed in typical embodiments.

Tissue Treatment Methods:

[0029] According to a broad aspect of the present invention, one ormore of the tissue treatments may be implemented as describedherein using various forms of treatment energy, such as one or moreof electromagnetic radiation (e.g., ablating optical energy,thermal optical energy, low level therapeutic optical energy, orradio frequency energy), ultrasound, and magnetism, alone or incombination with acupuncture or other therapeutic interventions.Low-level therapeutic optical energy applications are described inco-pending U.S. Provisional Application No. 60/687,256, filed Jun.3, 2005 and entitled TISSUE TREATMENT DEVICE AND METHOD, the entirecontents of which are expressly incorporated herein by reference.Embodiments may employ, as examples, laser acupuncture, lightacupuncture, laser/RF acupuncture, and the like. In modifiedembodiments, any of the tissue treatments described herein may beformed with a cutting or piercing tool, such as a needle orscalpel, alone or in combination with any of the aforementionedtissue-treatment generating implements. Typically, acupuncture maybe performed once a meridian or trigger point is identified.Magnets and/or magnetism applied in conjunction with the hereindiscussed techniques or ultrasound may be beneficial as well. Inparticular, tissue rejuvenation may employ ultrasound, RF, laser,light, and/or magnets applied individually or in combination.Ultrasound applied to the eye, e.g., by varying a frequency of theultrasound applied to eye tissue, may serve to recondition theeye.

[0030] In certain implementations of methods of the presentinvention, first tissue treatments may be formed in one or moreparts of the eye according to the disclosure herein, as an adjunctto, for example, other forms of refractive treatment or surgery.Such other forms, or form, of refractive treatment or surgery maycomprise, for example, second treatments (e.g., second tissuetreatments) formed in other ways and/or formed as described hereinbut in ways differing at least in part from, for example, one ormore of the devices, methods, or timing used to form the firsttissue treatments. For example, a non-laser form of refractivetreatment or surgery may comprise application of radio-frequency(RF) energy to the cornea lens and/or may comprise conductivekeratoplasty (CK). The CK, which may be appropriate for treatmentof mild cases of presbyopia, may, for example, introduce a smallamount of myopia into one eye so that the treated eye can be usedfor reading without corrective glasses. For instance, thetemperature of the lens may be raised, and edges of the cornea maybe manipulated to reshape the lens. Such methods may result insoftening of the lens so that an ability to change a shape of thelens may be restored.

Sclera and/or Ciliary Muscle:

[0031] According to an aspect of the present invention, tissuetreatments can be introduced into the sclera and/or ciliary muscle.In exemplary implementations, each of the tissue treatmentscomprises a shape, which may resembles a dot, spot, a short dash,or other object. The shapes and locations may be dependent on the"mapping" of the eye wherein, for example, there are rigidlylocations depicted by the scleral structure or the ciliary bodystructure. The eye muscles may also play a role in determiningshapes and/or locations of the tissue treatments that may berequired.

[0032] In certain implementations, which may or may not consist ofor comprise the application of ablating optical energy to thesclera, other definitions or meanings for the term "tissuetreatments" may apply.

[0033] One or more of the tissue treatments may be implementedusing various forms of treatment energy, such as one or more ofelectromagnetic radiation (e.g., ablating optical energy, thermaloptical energy, low level therapeutic optical energy, or radiofrequency energy), ultrasound, and magnetic implementations.

[0034] Regarding formation of tissue treatments using treatmentenergies, typical systems for providing treatment energies maycomprise one or more of an electromagnetic source such as a laser(e.g., a diode laser) having a predetermined wavelength, anultrasound device with a predetermined pulse, a radiofrequencymodule, an ultrasonic component, and combinations thereof.Electromagnetic energy devices may comprise, for example, lasershaving all wavelengths, such as lasers having wavelengths ranging,for example, from about 0.15 microns to about 3.2 microns.Exemplary laser beam spot sizes can range from about 0.001 mm up toabout 1.0 mm (or, alternatively, up to about 2.0 mm), and exemplarylaser energy per pulse values can range from about 0.1 mJ to about50 mJ depending on, for example, the pulse duration and the laserbeam spot size. Typical pulse laser widths may range from about 100nanoseconds to about 1000 microseconds. The areas to be treated canbe pre traced with a vascular laser or even the long pulse Er,Cr:YSGG, or long pulse Er:YAG, to minimize any bleeding.

[0035] Particular implementations of lasers for use on, forexample, the sclera may comprise Er:YAG, Er:YSGG, Er, Cr:YSGG, orCTE:YAG lasers operated at exemplary wavelengths ranging from about2.69 microns to about 2.8 microns, and about 2.94 microns; XeClexcimer lasers operated at an exemplary wavelength of about 308 nm;frequency-shifted solid state lasers operated at exemplarywavelengths of about 0.15 microns to about 3.2 microns; excimerlasers of ArF operated at an exemplary wavelength of about 93 nm;harmonic generations of Nd:YAG or Nd:YAL or Ti:sapphire lasersoperated at exemplary wavelengths of about 190 nm to about 220 nm;CO lasers operated at a wavelength of, for example, about 6.0microns and carbon dioxide lasers operated at a wavelength of, forexample, about 10.6 microns; diode lasers operated at exemplarywavelengths of about 0.8 microns to about 2.1 microns; gas lasersoperated at exemplary wavelengths of about 2.6 microns to about 3.2microns; and other gas or solid state lasers including flash-lampand diode-laser pumped lasers operated at exemplary wavelengths ofabout 0.5 microns to about 10.6 microns; and optical parametricoscillation (OPO) lasers operated at exemplary wavelengths of about2.6 microns to about 3.2 microns.

[0036] Tissue treatments or groupings of tissue treatments maycomprise random line shapes, (straight, curved, or otherwise), ormay comprise line shapes (straight, curved, or otherwise) formed ina pattern that is pre-determined based on a treatment customized toan area.

[0037] Scanners may be implemented to determine surfacetopographies and thicknesses of various layers of the eye, as knownto those skilled in the art. In addition, embodiments implementingscanners may further provide a benefit of modifiability oftreatments to a given patient. For instance a grouping or groupingsof tissue treatments may be formed during only a single procedureon the patient's eye (e.g., one surgical procedure during onepatient visit) and, subsequently, should a need be presented, oneor more follow-up procedures (e.g., implemented over multiplepatient visits) may be performed on the patient's eye. Theseprocedures may be performed in any order and/or any sequence of subgroupings.

[0038] When scanners or other automated or semi-automated systemsare used in connection with generation of tissue treatments, thepatient's sclera thickness can be measured, for example,pre-operatively and the tissue-treatment depth controlledaccordingly. In representative implementations, a scanning laser,or any other known tissue layer thickness measuring device, can beused to determine and subsequently control this depth. For example,the scanning laser may work with another optical or ultrasounddevice to detect the depth. Magnetic devices also may be used tothe same purpose. As another alternative, a sensor may determinedepth by automatically detecting, for example, a change in huewhile lasing. Generally, a device such as, e.g., an opticaldetector, a calorimeter, an ultrasound probe, a device forgenerating and detecting electric and magnetic fields, and atonometer can be used to measure depth of cut. In particular, atonometer can check pressure, and hence flexibility, providingreal-time feedback of an estimate of depth. Although the depthmeasurement determined with a tonometer may not be exactly the sameas that measured post-healing, the two measurements may be highlycorrelated.

[0039] Tonometric techniques of depth measurement may comprisemeasuring pressure at a plurality (e.g. three or four) of locationson the sclera before a procedure is initiated. Pressure measuredduring the procedure then may be interpreted according to theinitial pressure, with the interpretation providing an estimate ofdepth. A similar method may be applied to techniques for depthmeasurement using electric fields, magnetic fields, and chemicalsensing. A doctor may form a test perforation through theconjunctiva and into the sclera (i.e. extract a core sample), thetest providing an indication of elasticity, rigidity, and depth ofthe sclera. This indication may be used to determine and refine atreatment procedure Strictures in the sclera may relate toelasticity of the sclera while colors may aid in identifyingcomponents of the sclera. A combination of the above toolsincluding, in one example, an olfactory detector (e.g., sniffer),can be used to determine locations and appropriate times forperforming a procedure. In certain embodiments, applied in additionto as an alternative to any of the above features, patterns oftissue treatments can be determined by a device, which can markand/or apply the tissue treatments in areas based upon a rigiditytheory wherein the tissue treatments are imparted into the sclera(using, e.g., a scanning laser) in the determined areas.

[0040] When scanners are used, initial steps comprising, forexample, determining one or more reference points of the eye (e.g.,a center of the pupil, one or more points on the patient's retina,triangulated unique points on the patient's iris, and/or tissuetreatments or other markings formed on the patient's eye at anearly stage of a procedure for the purpose of, for example, thosetissue treatments being used as reference points) may beimplemented so that locations of tissue treatments may be definedand/or recorded relative to the one or more reference points foruse during the initial formation of the tissue treatments and/orfor use during follow-up procedure(s) wherein tissue treatments maybe modified and/or additional tissue treatments may be formed. Inaccordance with one aspect, tissue treatments formed during aninitial or earlier procedure are used as reference points duringremaining steps of the initial procedure and/or for the forming ofadditional tissue treatments during follow-up procedures. Forexample, rigidity mapping may be implemented wherein ultrasound isused to facilitate detection of tissue features such as a surfacetopography (e.g., locations of previously formed tissue treatments)for use as reference points. In accordance with an aspect of thepresent invention, tissue treatments (e.g., groupings of tissuetreatments) may be applied to all or substantially all of, forexample, a surface area (e.g., treatment area) of the sclera.According to yet another aspect of the present invention, tissuetreatments (e.g., groupings of tissue treatments) may be applied toportions of the sclera.

[0041] According to certain aspects of the present inventionwherein multiple procedures (e.g., implemented over multiplepatient visits) are implemented to apply the tissue treatments, aninitial procedure or procedures may comprise, for example,formation of one or more relatively sparsely-populated grouping(s)of tissue treatments, whereby during one or more subsequentprocedures additional tissue treatments may be introduced to moredensely populate (and/or to change a shape of) the one or morerelatively sparsely-populated groupings of tissue treatments. Forexample, in one implementation a grouping may be formed during aninitial procedure. A determination may be made that the patient maystand to benefit from the introduction of additional tissuetreatments, after which determination another grouping may beformed in a follow-up procedure. Following formation of the othergrouping, another evaluation may be made as to whether the patientmay stand to benefit from the introduction of even further tissuetreatments, and so on.

[0042] In this and other examples, the initial and follow-upgroupings of tissue treatments may share parts or all of the sameboundaries as distinguished from groupings having differentboundaries. In various embodiments, the various groupings may takeon a wide variety of different configurations, including differentshapes, distributions, and/or densities of tissue treatments. Allor substantially all of a surface area of, for example, a treatmentarea of the sclera can be provided with tissue treatments. In onerepresentative embodiment, the treatment area is a treatment zoneas described above in connection with FIGS. 1 and 2. The tissuetreatments covering the treatment area may comprise a wide varietyof different configurations, including different shapes,distributions, and/or densities of tissue treatments

[0043] The tissue treatments covering the superior rectus muscle,medial rectus muscle, inferior rectus muscle, and lateral rectusmuscle may comprise, in accordance with various embodiments, a widevariety of configurations, including different shapes,distributions, and/or densities of tissue treatments,

[0044] In certain embodiments, the tissue treatments are applied toportions of both the conjunctiva and/or the sclera. For example,one or more of the tissue treatments can be applied, for example,wholly or partially non-invasively to an underlying layer. In aparticular implementation, one or more of the tissue treatments canbe applied, wholly or partially non-invasively using, for example,components that focus the treatment energy on or into theunderlying sclera rather than on the conjunctiva.

[0045] According to a more specific example, ablating opticalenergy can be focused using optics into the sclera so that a peakconcentration of the ablating optical energy occurs within thesclera and a concentration of the optical energy in the conjunctivais substantially lower or, in one embodiment, below a predetermined(e.g., treatment, or, in another implementation, ablation)threshold. Dye enhancing the tissue to be treated can be used, forexample, to facilitate one or more of assuring that the treatmentenergy (e.g., laser energy) penetrates the desired area whereindifferent colors of dye may be used, assuring that the treatmentenergy (e.g., laser energy) penetrates to the appropriatepre-determined depth wherein different consistencies andcolorations can be used to this end, and allowing for betterviewing of the treatment area wherein dyes can be used inconjunction with the appropriate light source for "high lighting"and the background light can be reduced for enhancement. Forexample, the sclera can be stained with yellow dye allowing for thelocation of strictures (e.g., ciliary muscles) to be highlighted adarker yellow. In general, regarding dye enhancing of the tissue tobe treated according to the present invention, dyes may typicallybe red, green or dark in nature. The term "non-invasively" shouldbe interpreted to mean that portions of the conjunctiva penetratedby the treatment energy are not substantially affected (e.g., notablated), or are affected to a lesser extent than that to which theunderlying sclera is affected, by the treatment energy.

[0046] As used herein, and not merely in the context of the presentexample, the term "invasively" should be interpreted to mean thatportions of the tissue (e.g., sclera and or any other tissues)penetrated by the treatment energy are substantially affected(e.g., ablated) by the treatment energy. Invasive penetration oftissue by treatment energy may generate, for example, a tissuetreatment.

[0047] In other examples, one or more of the tissue treatments canbe applied to penetrate through the conjunctiva (e.g., toinvasively penetrate wherein penetrated portions of the conjunctivaare affected) and to treat the sclera. According to a particularimplementation, a collimated beam of ablating optical energy may bedirected through both the conjunctiva and through, for example, amajority or more of the thickness of the sclera, whereby tissues ofboth the conjunctiva and sclera are treated along the path of thecollimated beam. The parameter ranges can, in exemplaryembodiments, be dependent upon desired, predetermined or expectedwavelengths, lengths, widths and/or heights of incisions, andexemplary tissue parameters/types to be affected can includeconjunctival and scleral tissue. In certain implementations, thetreatment energy beam can be shaped in the form of a completetissue treatment (e.g., elongated kerf). A mapping will determinethe location, pattern, shape and landscape of the region acquiringthe treatment based on rigidity, muscle contraction, accommodation,and ciliary body location. The treatment energy beam can becompleted by contact or non-contact of the laser energy in a pulsemode, or continuous mode that is proximal to the treatment areausing a fiber based or scanner based delivery system with apredetermined software pattern or template. A beam splitter may beused to disperse energy of the beam in a pattern of the treatmentarea.

[0048] According to typical implementations, steps may beincorporated to ensure that pretreatment coagulating energy orsubsequent ablating energy does not adversely affect the retina orother tissues. Such implementations may embody one or more ofrelatively low energy levels, tissues-type and/or color (using,e.g., dyes) matching with relatively high-absorption wavelengths(e.g., Nd:YAG or Er, Cr:YSGG), and focusing of the energies well infront of the retina.

[0049] Any one or more of the preceding methods may be practiced orcombined with, for example, application of infrared energy as thetreatment-energy, wherein operating parameters can vary dependingon one or more of the desired type of enhancement, type of tissue,depth, length, width, other characteristic, and spectrum of energyused.

[0050] A dimension (e.g., a cross-sectional shape or area measuredin a direction transverse to a direction of propagation of thetreatment energy) of a tissue treatment may remain relativelyconstant through a depth of tissue (e.g., the conjunctiva and/orsclera) or may change with depth. For example, one or more tissuetreatments may be formed to have cross-sectional shapes or areasthat decrease (or, alternatively, increase) with depth into thesclera, such as would be the case, for example, with a circulartissue treatment having a diameter that decreases with increasingdepth into the sclera. In typical implementations, a tissuetreatment (e.g., a conically-shaped tissue treatment according tothe preceding example) may comprise, for example, a diameter thattapers from about 0.1 to about 100 percent with each 1 percent dropin depth. In a particular example, the diameter may drop by about 1percent for each 1 to 20 percent drop in depth. In the context of,for example, a tissue treatment being formed in or through thesclera, by way of treatment energy being directed non-invasivelythrough the conjunctiva (and/or the sclera), a tissue treatmentdimension (e.g., diameter) may taper within the sclera from about 1to about 100 percent with each 1 percent drop in depth and, in aparticular example, may drop by about 1 to about 20 percent foreach 1 percent drop in depth within the sclera.

[0051] In accordance with one aspect of the invention, affectedareas corresponding to tissue treatments are at least partiallyfilled-in by the body (e.g., via the body's natural response) withsub-conjunctiva tissue which may, for example, augment a propertyof the eye. For example, in the case of the sclera, the newsub-conjunctival collagen-based tissue infiltrating an affectedarea of the sclera may have a greater elasticity or be moreflexible than the original sclera tissue. The body's introductionof sub-conjunctiva tissue into affected areas thus may increase theflexibility of, for example, one or more of the sclera and ciliarymuscle and/or cause zonules to increase the lens accommodation. Inthe example of affected areas in the sclera, new sub-conjunctivaltissue in, for example, the sclera may facilitate or enhance afunctionality or other property of the underlying ciliary body.Thus, in response to the eye's attempts to see near and far, anaccommodation of the ciliary muscle may, in some instances, beincreased.

[0052] According to typical implementations, the scleral tissue maybe treated by directing treatment energy through the conjunctivaover the sclera with use of laser technology, whereby as previouslymentioned the sclera may be treated with treatment energy (e.g.,laser energy) aimed (e.g., focused) subconjunctivally, leaving theconjunctiva relatively undisrupted. For example, laser energy canbe directed to focus or converge on the underlying sclera wherein,for example, the laser energy has a relatively low power density(e.g., a large spot size) on the conjunctiva while at the same timehaving a relatively high power density (e.g., a relatively smallspot size) on the underlying sclera, and wherein the absorptionrate is that of sclera tissue so that the laser energy forms a "v"in the sclera. Tissue treatments may be formed in varying shapes.Typical shapes can include, as examples, "u" and "v" shapes.

[0053] One or more of the tissue treatments may be introduced withthe conjunctiva in place, wherein for example the conjunctiva isleft in a naturally-occurring orientation over the sclera. In suchembodiments, penetration paths through/into the conjunctiva andsclera may be aligned or substantially aligned. For example, a beamof electromagnetic energy may be directed through both theundisturbed conjunctiva and through, for example, a majority ormore of the thickness of the sclera. The beam may travel throughthe conjunctiva in a non-invasive or invasive manner.

[0054] In certain embodiments, fluids, including water, sterilewater or conditioned fluids, such as described in U.S. Pat. Nos.5,785,521 and 6,350,123, the contents of which are incorporatedherein by reference, may be added to ensure or aid in the cosmeticappeal of the treated tissue and/or to assist with healing time orother properties. For example, fluid (e.g., sterile water) may beapplied by way of a small air mister or sprayer line affixed, forexample, to a treatment energy (e.g., laser) device (e.g.,handpiece) at or for any of the above-noted times or purposes. Theline may comprise, for example, tubing (e.g., clip-on and/orsilicone based tubing) secured to an outside or built into thedevice and a fluid dispensing input disposed on the device.

[0055] The fluid-dispensing input may be activated, for example, tofacilitate manual or powered dispensation of fluid. Manualdispensation may be implemented by way of, for example, a lineleading to or integrally formed with a detachable container (e.g.,pod) that can be squeezed by a user to dispense fluid (e.g.,sterile water pre-packaged into a single-use, disposable pod), andpowered dispensation may be implemented by way of a toggle buttonto initiate a powered output of fluid at, for example, a relativelylow flow rate and pressure. An atomized distribution of fluid(e.g., sterile water) particles may be automatically applied to thetarget tissue during application of treatment energies, forexample. Suction may be applied to any of the foregoingimplementations, as well, for removing fluids, debris and/orliquids.

[0056] According to modified embodiments, groupings of tissuetreatments of the present invention may be disposed around cuts(e.g., kerfs) to the sclera implemented in accordance with othertechnologies. In other modified embodiments, as an alternative oraddition to any of the embodiments described herein, tissuetreatments may be arranged to approximate or resemble prior-artsurgical-formation shapes. For instance, tissue treatments may beapplied to resemble, or in combination with, correctional patternsas described in U.S. Pat. No. 6,263,879, the contents of which areexpressly incorporated herein by reference. In implementationswherein tissue treatments of the present invention are applied incombination with one or more of the patterns or ablation patternsdisclosed in the aforementioned patent, the tissue treatments canbe disposed for example along part or all of the boundary(ies) ofthe linear ablation pattern(s) with or without the ablationpattern(s) being formed as well. In modified embodiments, any ofthe above tissue treatments may be applied in combination with anyother eye treatments to the extent compatible, or modifiable to becompatible, by one skilled in the art, with the present tissuetreatments.

[0057] The above-described embodiments have been provided by way ofexample, and the present invention is not limited to theseexamples. Multiple variations and modification to the disclosedembodiments will occur, to the extent not mutually exclusive, tothose skilled in the art upon consideration of the foregoingdescription. Additionally, other combinations, omissions,substitutions and modifications will be apparent to the skilledartisan in view of the disclosure herein. Accordingly, it isintended that the present invention not be limited by the disclosedembodiments, but be defined by reference to the appended additionaldisclosure in claims format.

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