CA2144761A1 - Adjustable devices for corneal curvature adjustment - Google Patents
Adjustable devices for corneal curvature adjustmentInfo
- Publication number
- CA2144761A1 CA2144761A1 CA002144761A CA2144761A CA2144761A1 CA 2144761 A1 CA2144761 A1 CA 2144761A1 CA 002144761 A CA002144761 A CA 002144761A CA 2144761 A CA2144761 A CA 2144761A CA 2144761 A1 CA2144761 A1 CA 2144761A1
- Authority
- CA
- Canada
- Prior art keywords
- ring
- thickness
- body member
- cornea
- eye
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Abandoned
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M31/00—Devices for introducing or retaining media, e.g. remedies, in cavities of the body
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/14—Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
- A61F2/147—Implants to be inserted in the stroma for refractive correction, e.g. ring-like implants
Abstract
The intrastromal corneal ring (ICR) (47) is adjustable in thickness and has an elongated, flexible preferably transparent or translucent body which forms a circle. The thickness may be adjusted prior to insertion into the cornea and may not be further adjustable after insertion. In preferred embodiments, the thickness of the ICR may be adjusted after insertion to more precisely adjust the shape of the cornea (12) and focus the light entering the eye on the retina (18).
Description
2~47~7 W0 94~06504 PCI'/US93/08766 a~J~TpR~-R l)Kv ~ F~P I ~ltN KA~
C~2VA'rr~R An.l~TMRNT
Fi ~1~ of ~h~ Tny~nt~nn ThiJ invention i~ in the general field of medtcal tqchnology and relate~ specifically to an intrastromal cQrneal ring designed such that it-thickness can be ~aried in a ~ann^r 80 as to vary the corn--l curvature to correct vision.
Rat~ . o.n..~ nf ~-h~- Tn~Pnti~ n A~omalie~ in the shape of the eye and specifically the ~hape a~ defined in part by the corneal can cause visual dtsorder~. Hyperopla occurs when the eyeball i- too short. In such a case, parallel ray~ fron greater than 20 feet focus kDhtnA the reti~a. Myopia, on the other ha~d occur~ when the ey~ball i~ too long. The focus of parallel ray~ in tht- case i8 in front of the retina. A~tigmatism i8 a condition in ~hich the parallel ray- of light do not come to a single point, but rather have a variable focus due to the fact that the cornea is aspherical and refract~ light in a different meridian at different distance~. Some dcJ~ea of astigmatism i8 normal, but ~here it is too high, it must be co~c_~ed in order to provide acceptable ~ision.
Condltions such a~ hyperopia, myopia _nd astigmatism are usually corrected by ~1~3qe~ or c~ta~ct lenses. Surgical methods for the cu-~c_-ion of such disorder~ have been cited in the literature a~d include radial keratotomy (see e.g. ~.S. F~tent~ Nos. 4,815,463 2 1 ~
W094/~ PCT/US93/~7 und ~,688,570) nd l~Jer corn~al -hl~ttr~ (~ee e g U S
PatQnt No. ~, 9~1,093) Purther, th general method Or implanti~g ri~g~ ln the corneal stroma to changc the curvature of the cor~ kno~n Pr vioue work involving the ~mplantation of polymethylmethacrylate (PMM~) ringe, allograft cor~eal ti~ue and ~drcyel~ ie well docum~nted One of the ring devicee involvee a ring dQ-lg~ t~at allow a ~pllt ri~g to be in~erted into a chann^l . Th~ rha,nnel i8 formRd by dissecting the 8tromal layer of the CQr~- using a minimally invasiv~ inclslon mereafter, the implant i~ inserted into the rhannel and the ch~nn~l $~ sutured shut U S Patent No. 4,452,235, which is herein incolyo~at d by reference ln lt~ entirety, de~crlbe~ a method ~d appar~tu~ for corn--l curvatur~ ad~ustment Th~ method involve~ inserting one ~nd of a split end ad~u~ting ring into the cornea of the eye and moving the ring in a circular path until it~ endJ meet The ends are thereafter ad~usted relat$ve to each other 80 th_t the eod~ can be co~n~cted When 80 _o ~eoted the shape of the eye wlll have assumed a de-lred cur~ature Variou~ devlce~ were reguired in order to facllitate th im~l-ntation of tho ring~ of the type described $n U S Patent ~,~52,235 Such a holder for l~ertlng c~rn^~t cur~ature ad~u~table ring~ i~ described withl~ U S ~ tent ~,961,74~ issued October 9, 1990 Further, prior to in~erting the ring it i~ nece-P-ry to cut an a~nnl ar ~hann-t ~ithin th~ c^,rn - and a devlce for cutting such a ~h tnnel 1B di~clo~ed ~lthin U S Patent 4,766,895 ~ te~t October 30, 1988 Other de~ice~ for ad~usting the cQrr^~l curvature havo been disclosed ouch a- the de~ice hown ~ithin ~ 8 Patent 4,671,276 issued June 9, 1987 In addltio~, deviceJ for affecting other part~ of the eye ~uch aJ an iriJ reta~ntng de~ice are dl~closed within 2 ~
WO ~/~ PCT/US93/~7
C~2VA'rr~R An.l~TMRNT
Fi ~1~ of ~h~ Tny~nt~nn ThiJ invention i~ in the general field of medtcal tqchnology and relate~ specifically to an intrastromal cQrneal ring designed such that it-thickness can be ~aried in a ~ann^r 80 as to vary the corn--l curvature to correct vision.
Rat~ . o.n..~ nf ~-h~- Tn~Pnti~ n A~omalie~ in the shape of the eye and specifically the ~hape a~ defined in part by the corneal can cause visual dtsorder~. Hyperopla occurs when the eyeball i- too short. In such a case, parallel ray~ fron greater than 20 feet focus kDhtnA the reti~a. Myopia, on the other ha~d occur~ when the ey~ball i~ too long. The focus of parallel ray~ in tht- case i8 in front of the retina. A~tigmatism i8 a condition in ~hich the parallel ray- of light do not come to a single point, but rather have a variable focus due to the fact that the cornea is aspherical and refract~ light in a different meridian at different distance~. Some dcJ~ea of astigmatism i8 normal, but ~here it is too high, it must be co~c_~ed in order to provide acceptable ~ision.
Condltions such a~ hyperopia, myopia _nd astigmatism are usually corrected by ~1~3qe~ or c~ta~ct lenses. Surgical methods for the cu-~c_-ion of such disorder~ have been cited in the literature a~d include radial keratotomy (see e.g. ~.S. F~tent~ Nos. 4,815,463 2 1 ~
W094/~ PCT/US93/~7 und ~,688,570) nd l~Jer corn~al -hl~ttr~ (~ee e g U S
PatQnt No. ~, 9~1,093) Purther, th general method Or implanti~g ri~g~ ln the corneal stroma to changc the curvature of the cor~ kno~n Pr vioue work involving the ~mplantation of polymethylmethacrylate (PMM~) ringe, allograft cor~eal ti~ue and ~drcyel~ ie well docum~nted One of the ring devicee involvee a ring dQ-lg~ t~at allow a ~pllt ri~g to be in~erted into a chann^l . Th~ rha,nnel i8 formRd by dissecting the 8tromal layer of the CQr~- using a minimally invasiv~ inclslon mereafter, the implant i~ inserted into the rhannel and the ch~nn~l $~ sutured shut U S Patent No. 4,452,235, which is herein incolyo~at d by reference ln lt~ entirety, de~crlbe~ a method ~d appar~tu~ for corn--l curvatur~ ad~ustment Th~ method involve~ inserting one ~nd of a split end ad~u~ting ring into the cornea of the eye and moving the ring in a circular path until it~ endJ meet The ends are thereafter ad~usted relat$ve to each other 80 th_t the eod~ can be co~n~cted When 80 _o ~eoted the shape of the eye wlll have assumed a de-lred cur~ature Variou~ devlce~ were reguired in order to facllitate th im~l-ntation of tho ring~ of the type described $n U S Patent ~,~52,235 Such a holder for l~ertlng c~rn^~t cur~ature ad~u~table ring~ i~ described withl~ U S ~ tent ~,961,74~ issued October 9, 1990 Further, prior to in~erting the ring it i~ nece-P-ry to cut an a~nnl ar ~hann-t ~ithin th~ c^,rn - and a devlce for cutting such a ~h tnnel 1B di~clo~ed ~lthin U S Patent 4,766,895 ~ te~t October 30, 1988 Other de~ice~ for ad~usting the cQrr^~l curvature havo been disclosed ouch a- the de~ice hown ~ithin ~ 8 Patent 4,671,276 issued June 9, 1987 In addltio~, deviceJ for affecting other part~ of the eye ~uch aJ an iriJ reta~ntng de~ice are dl~closed within 2 ~
WO ~/~ PCT/US93/~7
-3-U S Pat-nt ~,782,8ao i-sued N~v~mber 8, 1988 and a var$ab1e foc~s l~nJ which 1~ disclo~ed within U 8 Patent 5,066,301 ~ November 19, 1991 Mbre recently a method of changing corne7 curvature by i~ecting a gel i~to the cQrn~~ wa- disclosed in U 8 ~t~nt 5,090,955 i~ued ~Qbruary 25, 1992 The present i~ention de~cribe~ split ri~g de~ice~ which are in~erted in the corne-l troma and ha~e ad~uJtable thlc~neq~^~ which provide certain advantages and improvement- as romrared to earlier intrastromal corn--1 rings f 1-he TnvPntt ~n The present invPntt~ an intrastramal 15 corn^~l ring ~CR) of ad~ustable thic~ness whlch ha8 an elo~gat~, flexible body which forms a circle The ICR
i8 of a ~ize such that it ca~ be inserted lnto a human eye and ~pecifically into the outer periphery of the cornea of a human eye The IC~ i~ comprised of a mat rial ~hich io compatible with human ocvl ar tissue and ~peclfically comp t~ble ~ith cQrn-~l tissue The means for ad~u~ting the thicknes~ of the ring may be fonmed in Deveral different configuration~ or embodiments Two open end~d ~nnnl~r body member~ may be inte~aeoted in such a manner that the distance between the body member~
can be ad~usted to provide different thir~n-^-e~ and thereby obtain different degree~ of change in the hape of the eye effecting the focus of light on the retina The eso-~ce of the ~ t invent~ lles in the ability of the ring to be ad~usted in thick~ess 80 that it i- not nece~--ry to tock a plurality of different ring~ of different ize- to be used in co~n-~tion with the method for ad~usting the shape of the cor~,e- of an y Accordingly, the present inv^nt~
provide- a plurality of different embod1ments of ICRs 2.~
WO94/~M PCT/US93/~7
i8 of a ~ize such that it ca~ be inserted lnto a human eye and ~pecifically into the outer periphery of the cornea of a human eye The IC~ i~ comprised of a mat rial ~hich io compatible with human ocvl ar tissue and ~peclfically comp t~ble ~ith cQrn-~l tissue The means for ad~u~ting the thicknes~ of the ring may be fonmed in Deveral different configuration~ or embodiments Two open end~d ~nnnl~r body member~ may be inte~aeoted in such a manner that the distance between the body member~
can be ad~usted to provide different thir~n-^-e~ and thereby obtain different degree~ of change in the hape of the eye effecting the focus of light on the retina The eso-~ce of the ~ t invent~ lles in the ability of the ring to be ad~usted in thick~ess 80 that it i- not nece~--ry to tock a plurality of different ring~ of different ize- to be used in co~n-~tion with the method for ad~usting the shape of the cor~,e- of an y Accordingly, the present inv^nt~
provide- a plurality of different embod1ments of ICRs 2.~
WO94/~M PCT/US93/~7
-4-which are each ad~u~table in termJ of their thir~ne-~Thc thicknes~ ad~u~m~nt may occur prior to the in~ertion of the ICR into the cornea and may ~ot be further ad~ustable after i~sertio~ However, in the preferred embodiment~ of the invention the ICR iJ i~serted at a thickne~- ~hich i- believed to be prop~r and may be ad~u~ted thereafter in order to preci~ely define the de~$red thickne~- and thereby re precisely ad~uJt the ~hape of the cor~ea and focu~ the light enterlng the eye on the ret~ na .
A primary ob~ect of the invention is to provide an ~CR having an ad~ustable thir~neQs An advantage of the invention is that a single ring of ad~ustable thlr~n~-~ can b- used thereby eliminating the need for multlple ring~ of different thlckne~
A feature of the invention i~ that the rlng thlr~ne^- ca~ be ad~u~ted whlle the rlng i~ in place Another advantage of the ring i~ that it can be read~u~ted at later times in order to read~ust the curvature of the eye as nee~
The~e and other ob~ects, advantages and features of the present invention will become apparent to those persons skilled in the art upon re~ng the details of the ~tructur- and operation aJ more fully set forth below, reference being s de to the accompanying drawings form~ng a part hereof wherein like ~ymbol~ refer to like c~ t~ thro~gho~t 30 Rr~ef n~ r~l~t~nn of the nr~w~na~
Pigure 1 i- a schematic ~ ~n~tion of a hort~o~t~l ~ection of the eye Pigure 2 i~ a ~chematic illu~tration of the anterior portion of the eye ~howing the ~ariou- layers of 3~
2~7~
WO ~/~ PCT/US93/087 the corn~a ~ith an intra~tramal cornQal ring lnserted thereln.
Figure 3 is a chematic repr~--nt~tion ~howing how lighe move~ through a normal eye to focuJ on the r~t~ n~ . .
~ igure ~ i~ a schematic representation showing how light move~ through a myopic eye and fo~e- in front of the reti~a.
Figure 5 i8 a perspective ~iew of one e~ment of the ICR of the inv~ntlo~ inserted within a cornea o~ a h~ n eye.
Flgure 6 include~ a plane vlew (6A) and a persp4ctive ~ectional view (6B) of an ICR of the invention.
Figure~ 7A and 7B are perspective view~ ~howing a ratcheted height ad~ustment embodiment in two po~ition~.
Flgure~ 8A and 8B are per~pecti~e view~ showing a threaded helght ad~ w tment embodiment in two positions.
Figure~ 9A and 9B are perspective views of an inflatabl- embodiment in a deflated and inflated ~tate.
Figure 10 is a cros- sect~ Q"~ 1 view of a tube centered embodiment.
Figures llA and llB are pe ~e_~ive ~iews of a notched embodiment in two po~itions.
FigureJ 12A and 12B are perspective view~ of a smooth surface erhQA~ment in two position~.
Figures 13, 13A, 13B, 13C, 13D and 13B are different view~ showing how the end~ of the -nn~ r body member might overlap.
Figure~ 14A and 14~ ~ho~ a ~a~ed shim embodi~est of the inve~tion with and without the shims in place.
WOg4~ 4 2~ 7~ PCT/US93/~7~
Figure~ 15A and 15~ how a ~piral ~pring embodiment of the invention in a rolla~ed po~ition and a~ the ~piral might be ~n~erted net~le~ nP~r~Rt~tn of ~h~ Tnv~nt~n ~ efore the ad~u8tab1e i~trastromal corne~l ring and it~ ~arlou~ embodiments and configurations and methods of use are described, it i~ to be under~tood that thi~ invention iJ not l~ted to the particular ~mbodiment~, configuration~, material~ and steps described a~ ~uch may, of course, vary It i8 al~o to be understood that the t~r~nology uoed herein i~ for the purpose of de-cribing particular embod1ment~ only and i8 not ~nt~nde~ to be limlting, ~ince the scope of the pre~ent ~nvention will be lim~ted only by the ~pr~nA~d claim~
The ba~ic ~tructure, function and operation of the ad~ustable intra~tromal ~ ring~ of the invention i~ ~hown and discusced in connection with Figure~ 1-6 Figure~ 7-15 ~how eight different e~o~mentJ of the invention which show six baslc configurations whereby the rings can vary in terms of their thicknes~ and/or he~ght Further, the ring end~
can be c~nnocted to each other without the u~e of additional co~r~n^n~ in a manner 80 as to provide a 2~ umooth and cont~n~o~lr interconnection between the ends ~o that the ~urface of the ring appear~ substantially 8 oth and co~t~n~ along it~ entire ~urfac~ even at the i~terconne-tlo~ of the ring ends The different ~m~o~ iments shown in Figures 7-15 can each include a n~ er of different ~ubembodim~nts by ~arying feature- such as the material, the manner in which the ring ends are inte,c, ?cte~ and the cross ~ectional ~urface par~m~ter- of the ring e g forming the ri~g from cros~ ~ections in the form of a circle,-~guare, rectangle, triangle, oval, etc Altho~h ~ nt-mh~r of wo ~/~ 2 1 ~ 1~ 7 ~ ~ PCT/US93/~7~
c figurat~on are ~hown other- are pc~ible and are contemplated by thi- invention Purther other pos~lble mean~ of ad~u~tlng the ring thlckne~J are contemplated by thi~ inv~nt~o~ ~t i8 preferable if the invent~n~ i8 constructed such that the ring size can be ad~u~ted while the ring i~ in place i~ the eye Before discus~ing the`specific embodiments of Figures 7-15 th general structure and method of use of ad~u~table intra~tromal corneal ring~ will be de~cribed in co~n~ction with Figures 1-~ and thereafter generalized info.~tion relating to the ring~ of the present invention in connoctio~ with Figure~ 5 and 6 Figure 1 show~ a hori~o~tal section of the eye with the globe 11 of the eye resembling a ~phere with an anterior bulged ~pherical portion repre~nt~ng the cornea The globe 11 of th- eye consi~t~ of three cQ~c~ntric coverings enclo~ing the variou~ tr_nsparent media through which the light must pas~ before rearh~ng the ~e~siti~e retina 18 The outermo~t covering is a fibrouJ protective portion the posterior five-sixths of which i~ whlte and opague and called the ~clera 13 and ~ometime~ referred to aJ the whlte of the eye where vi~lble to the front The anterior one-sixth of thi~
outer layer i~ the transparent co~n~ 12 A m~ddle covering i~ mainly va~cular ~n~
nutritive in function _nd is compri~ed of the choroid 14 ciliary body 16 and iri~ 17 The choroid 14 generally fl~nc~onJ to ~a~ta~n the ret~na 1~ Th~ ciliary body t6 30 i8 invol~ed in ~usFen~ the lens 21 and accommodation of the leDs The iri~ 17 i~ the mo~t a~terior portion of the middle covering of the eye and i~ arranged in a frontal pl_ne It i~ a thin circular disc co~ea~
to the ~ap~ragm of a c_mera and i~ perforated near its crn~er by a circular aperture called the pupil 19 The W094/~ ~4 ~ r!~ 1 PCT/US93/~7 ize of the pupil ~arie~ to regulate ths amDunt of light which re-chs~ th retina 18. It co~t~-ct- al-o to accommodation, which eerves to sharpe~ the focu~ by dim~nt~h~n~ ~pherical aberratio~. ~he iri- 17 divides the space between the cornea 12 and the len~ 21 into an anterior cha~ber 22 and posterior cha~ber 23. The innermo~t portion of covering i~ the retina 18, consi~ting of nerve element~ which form the true receptive portion for visual impre~ions.
The retina 18 i~ a part of the bra$n arising as an outgrowth from the fore-brain, with the opt$c nerve 24 serving a~ a fiber tract connecting the retina part of the brain with the fore-brain. A layer of rods and cone~, lying ~u~t beneath a pigmented epithelium on the anterlor wall of the retina ~erve a- vi~ual cell~ or p~toreceptor whlch transform physlcal energy (light) into nerve impul~es.
The vitreous body 26 i~ a transparent gelatinou~ mas~ whlch fill~ the posterior four-fifths of the globe 11. At it~ ~ides it 8UyyG~ the ciliary body 16 and th- retina 1~. A frontal ~ cqr--h~ped depression ho~r?8 the len~.
The lens 21 of the eye i~ a transparent bi-co~ body of crystalline appearance place~ between the 2S iri~ 17 and vitreou~ body 26. Its axial dlameter varies markedly with accommodation. A ciliary zonule 27, consistlng of tran~parent fibers pa~sing between the ciliary body 16 and lens 21 serves to hold the lens 21 in position and enables the ciliary muscle to act on it.
Referring again to the cornea 12, this outermost fibrouo transparent coating l~7~1e~ a watch glas~. It~ cur~ature is somewhat greater than the rest of the globe and is i~lly ~pherical in nature.
However, often it i~ more curved in one meridian than another giving rlse to astigmatlsm. A central third of wo ~/~ 2 ~ PCT/US93/~7~
g the cornea lo called the optir~l zone ~ith a light flatten~g t~n~ place out~ardly thereof as the cornea thicken- toward- itJ periphery Nbst of the refractlon of light ~triking the eye takeo place aJ the light p~?e~
through the corno~
Referring to ~igure 2, a more detailed drawing of the anterior portlon of the globe ~how the varlouo layero of the corn^- 12 compri-ing an epithellum 31 Bpithelial cell~ on the surface thereof fu~ctlon to act aJ the ma~n protectlon layer of the cornea 12 These eplthelial cell~ are rlch ln gl~uye~, enzyme~ and acetylcholine and thelr actlvity re~late~ the corne-corpu~clQ~ and co~trolo the traDsport of water and electrolyte~ through the lamellae of the troma 32 of the ~r~- 12 An anterlor limitlng lamina 33, referred to a~
Bowman'~ membrane or layer, lo pooltio~ed between the eplthelium 31 a~d the stroma 32 of the cornea The strcma 32 i~ comprioed of lamella having band- of fibrll~
parallel to each other and cros-ing th whole of the cornea While most of the flbrow hanA~ are parallel to the ~urface, ~ome are oblique, esp~c~ally anteriorly A
posterior limitlng lamina 34 1- referred to a~ De~cemet~
membrane It 1~ a ~trong membrane ~harply defined from the ~troma 32 and resl~tant to pathologlcal ~ r~ of the co~n~-.
~ he enAo~h^lium 36 1~ the mo~t po~terlor layer of the corn-~ a~d consl~t~ of a slngle layer of cell~
which aid in ~nta~n~ng the transparency of the ro~n^-The l~mbu~ 37 i~ the tran~ltion zone betwee~ thecon~u~ctlva 38 and ~clera 13 on the one hand and the cornea 12 o~ the other A cros~ ~ectlonal vlew of an lntra~tromal-corn~-l ring ~7 of the inventio~ iJ 8hOWn wlthin the ~troma 32 of the rorn~a 12 The r$ng ~7 i~ ~lac~ in the - - 2~7~1 W094/~ PCT/US93/~7~
Jtroma 32 by making an initial inci-ion into the cornea 12 and then ro~t~n~ng to ~qp~rrte the ~troma of the corne~ in a circular directi from the in$tial lnciJion be~eath the 8urface of the corn^- 80 a~ to provide a compl~t- -nnlll rr rhanne~ wlthln the cor~ea 12 The ring 47 i8 pl~cs~ ~ithin the nn-ll ar chaDnel Plgure 3 shows the globe of the eye having a rorn^- with a normal curvature 41 If parallel ray~ of llght pas~ through the c~_ e-l urface ~1 of ~$gure 3, they are refracted by the corneal ~urfaces to converge eventually near the retina of the ey- The diagram of P~gure 3 di~co~nt-, for the purpo~es of thiJ ~ lon, the refractlve effect of the lens or other portions of the eye The eye deplcted in Pigure ~ i8 myopic The corneal curvature 43 cause~ the light ray~ to refract into focu~ at a point in the ~itreou~ body whlch i~ ~hort of the retinal surface If an ICR i~ implant~ into the chord of the rorne~ such that the radiu~ of curvature of the corne- 1~ uniformly increased, the central curvature of the cornea i~ flattened ~ight ray~ refracted by the now flattened corne-l surface will be refrarte~ at a smaller angle and thus converge at a more distant point ~uch a8 directly on the retina The ICR~ of the present invention make lt possible to ad~ w t the radius of curvature of the cornea without adver~ely affectlng its natural sphericity Wher- there i~ ~eriou~ a~tigmatism, the natural sphericity will not be altered ~uch that the astigmatism will be ~ignificantly increased ~cA~vær, where there i~
~ignifica~t a~tlgmatl~m that result~ in impaired ~ls$on, the ICR of the i~vention may actually improve the sphericity to reduce such astigmatism and i~r~e vislon AJ 18 shown in Pigures 3 and ~ by changing the curvature from a curvature 43 to a curvature ~1 the focal point can be correctly positioned on the retina A omall 2 ~
W094/0~4 PCT/US93/~7~
degr-e of curvature cha~ge can aff-ct the focal point of th l~ght entering the eye Accordingly, it i- difficult tQ choo~e the co~sect thickne~J of an ~ntrastrcnal corneal ring to be inserted ln the troma of tbe cornea
A primary ob~ect of the invention is to provide an ~CR having an ad~ustable thir~neQs An advantage of the invention is that a single ring of ad~ustable thlr~n~-~ can b- used thereby eliminating the need for multlple ring~ of different thlckne~
A feature of the invention i~ that the rlng thlr~ne^- ca~ be ad~u~ted whlle the rlng i~ in place Another advantage of the ring i~ that it can be read~u~ted at later times in order to read~ust the curvature of the eye as nee~
The~e and other ob~ects, advantages and features of the present invention will become apparent to those persons skilled in the art upon re~ng the details of the ~tructur- and operation aJ more fully set forth below, reference being s de to the accompanying drawings form~ng a part hereof wherein like ~ymbol~ refer to like c~ t~ thro~gho~t 30 Rr~ef n~ r~l~t~nn of the nr~w~na~
Pigure 1 i- a schematic ~ ~n~tion of a hort~o~t~l ~ection of the eye Pigure 2 i~ a ~chematic illu~tration of the anterior portion of the eye ~howing the ~ariou- layers of 3~
2~7~
WO ~/~ PCT/US93/087 the corn~a ~ith an intra~tramal cornQal ring lnserted thereln.
Figure 3 is a chematic repr~--nt~tion ~howing how lighe move~ through a normal eye to focuJ on the r~t~ n~ . .
~ igure ~ i~ a schematic representation showing how light move~ through a myopic eye and fo~e- in front of the reti~a.
Figure 5 i8 a perspective ~iew of one e~ment of the ICR of the inv~ntlo~ inserted within a cornea o~ a h~ n eye.
Flgure 6 include~ a plane vlew (6A) and a persp4ctive ~ectional view (6B) of an ICR of the invention.
Figure~ 7A and 7B are perspective view~ ~howing a ratcheted height ad~ustment embodiment in two po~ition~.
Flgure~ 8A and 8B are per~pecti~e view~ showing a threaded helght ad~ w tment embodiment in two positions.
Figure~ 9A and 9B are perspective views of an inflatabl- embodiment in a deflated and inflated ~tate.
Figure 10 is a cros- sect~ Q"~ 1 view of a tube centered embodiment.
Figures llA and llB are pe ~e_~ive ~iews of a notched embodiment in two po~itions.
FigureJ 12A and 12B are perspective view~ of a smooth surface erhQA~ment in two position~.
Figures 13, 13A, 13B, 13C, 13D and 13B are different view~ showing how the end~ of the -nn~ r body member might overlap.
Figure~ 14A and 14~ ~ho~ a ~a~ed shim embodi~est of the inve~tion with and without the shims in place.
WOg4~ 4 2~ 7~ PCT/US93/~7~
Figure~ 15A and 15~ how a ~piral ~pring embodiment of the invention in a rolla~ed po~ition and a~ the ~piral might be ~n~erted net~le~ nP~r~Rt~tn of ~h~ Tnv~nt~n ~ efore the ad~u8tab1e i~trastromal corne~l ring and it~ ~arlou~ embodiments and configurations and methods of use are described, it i~ to be under~tood that thi~ invention iJ not l~ted to the particular ~mbodiment~, configuration~, material~ and steps described a~ ~uch may, of course, vary It i8 al~o to be understood that the t~r~nology uoed herein i~ for the purpose of de-cribing particular embod1ment~ only and i8 not ~nt~nde~ to be limlting, ~ince the scope of the pre~ent ~nvention will be lim~ted only by the ~pr~nA~d claim~
The ba~ic ~tructure, function and operation of the ad~ustable intra~tromal ~ ring~ of the invention i~ ~hown and discusced in connection with Figure~ 1-6 Figure~ 7-15 ~how eight different e~o~mentJ of the invention which show six baslc configurations whereby the rings can vary in terms of their thicknes~ and/or he~ght Further, the ring end~
can be c~nnocted to each other without the u~e of additional co~r~n^n~ in a manner 80 as to provide a 2~ umooth and cont~n~o~lr interconnection between the ends ~o that the ~urface of the ring appear~ substantially 8 oth and co~t~n~ along it~ entire ~urfac~ even at the i~terconne-tlo~ of the ring ends The different ~m~o~ iments shown in Figures 7-15 can each include a n~ er of different ~ubembodim~nts by ~arying feature- such as the material, the manner in which the ring ends are inte,c, ?cte~ and the cross ~ectional ~urface par~m~ter- of the ring e g forming the ri~g from cros~ ~ections in the form of a circle,-~guare, rectangle, triangle, oval, etc Altho~h ~ nt-mh~r of wo ~/~ 2 1 ~ 1~ 7 ~ ~ PCT/US93/~7~
c figurat~on are ~hown other- are pc~ible and are contemplated by thi- invention Purther other pos~lble mean~ of ad~u~tlng the ring thlckne~J are contemplated by thi~ inv~nt~o~ ~t i8 preferable if the invent~n~ i8 constructed such that the ring size can be ad~u~ted while the ring i~ in place i~ the eye Before discus~ing the`specific embodiments of Figures 7-15 th general structure and method of use of ad~u~table intra~tromal corneal ring~ will be de~cribed in co~n~ction with Figures 1-~ and thereafter generalized info.~tion relating to the ring~ of the present invention in connoctio~ with Figure~ 5 and 6 Figure 1 show~ a hori~o~tal section of the eye with the globe 11 of the eye resembling a ~phere with an anterior bulged ~pherical portion repre~nt~ng the cornea The globe 11 of th- eye consi~t~ of three cQ~c~ntric coverings enclo~ing the variou~ tr_nsparent media through which the light must pas~ before rearh~ng the ~e~siti~e retina 18 The outermo~t covering is a fibrouJ protective portion the posterior five-sixths of which i~ whlte and opague and called the ~clera 13 and ~ometime~ referred to aJ the whlte of the eye where vi~lble to the front The anterior one-sixth of thi~
outer layer i~ the transparent co~n~ 12 A m~ddle covering i~ mainly va~cular ~n~
nutritive in function _nd is compri~ed of the choroid 14 ciliary body 16 and iri~ 17 The choroid 14 generally fl~nc~onJ to ~a~ta~n the ret~na 1~ Th~ ciliary body t6 30 i8 invol~ed in ~usFen~ the lens 21 and accommodation of the leDs The iri~ 17 i~ the mo~t a~terior portion of the middle covering of the eye and i~ arranged in a frontal pl_ne It i~ a thin circular disc co~ea~
to the ~ap~ragm of a c_mera and i~ perforated near its crn~er by a circular aperture called the pupil 19 The W094/~ ~4 ~ r!~ 1 PCT/US93/~7 ize of the pupil ~arie~ to regulate ths amDunt of light which re-chs~ th retina 18. It co~t~-ct- al-o to accommodation, which eerves to sharpe~ the focu~ by dim~nt~h~n~ ~pherical aberratio~. ~he iri- 17 divides the space between the cornea 12 and the len~ 21 into an anterior cha~ber 22 and posterior cha~ber 23. The innermo~t portion of covering i~ the retina 18, consi~ting of nerve element~ which form the true receptive portion for visual impre~ions.
The retina 18 i~ a part of the bra$n arising as an outgrowth from the fore-brain, with the opt$c nerve 24 serving a~ a fiber tract connecting the retina part of the brain with the fore-brain. A layer of rods and cone~, lying ~u~t beneath a pigmented epithelium on the anterlor wall of the retina ~erve a- vi~ual cell~ or p~toreceptor whlch transform physlcal energy (light) into nerve impul~es.
The vitreous body 26 i~ a transparent gelatinou~ mas~ whlch fill~ the posterior four-fifths of the globe 11. At it~ ~ides it 8UyyG~ the ciliary body 16 and th- retina 1~. A frontal ~ cqr--h~ped depression ho~r?8 the len~.
The lens 21 of the eye i~ a transparent bi-co~ body of crystalline appearance place~ between the 2S iri~ 17 and vitreou~ body 26. Its axial dlameter varies markedly with accommodation. A ciliary zonule 27, consistlng of tran~parent fibers pa~sing between the ciliary body 16 and lens 21 serves to hold the lens 21 in position and enables the ciliary muscle to act on it.
Referring again to the cornea 12, this outermost fibrouo transparent coating l~7~1e~ a watch glas~. It~ cur~ature is somewhat greater than the rest of the globe and is i~lly ~pherical in nature.
However, often it i~ more curved in one meridian than another giving rlse to astigmatlsm. A central third of wo ~/~ 2 ~ PCT/US93/~7~
g the cornea lo called the optir~l zone ~ith a light flatten~g t~n~ place out~ardly thereof as the cornea thicken- toward- itJ periphery Nbst of the refractlon of light ~triking the eye takeo place aJ the light p~?e~
through the corno~
Referring to ~igure 2, a more detailed drawing of the anterior portlon of the globe ~how the varlouo layero of the corn^- 12 compri-ing an epithellum 31 Bpithelial cell~ on the surface thereof fu~ctlon to act aJ the ma~n protectlon layer of the cornea 12 These eplthelial cell~ are rlch ln gl~uye~, enzyme~ and acetylcholine and thelr actlvity re~late~ the corne-corpu~clQ~ and co~trolo the traDsport of water and electrolyte~ through the lamellae of the troma 32 of the ~r~- 12 An anterlor limitlng lamina 33, referred to a~
Bowman'~ membrane or layer, lo pooltio~ed between the eplthelium 31 a~d the stroma 32 of the cornea The strcma 32 i~ comprioed of lamella having band- of fibrll~
parallel to each other and cros-ing th whole of the cornea While most of the flbrow hanA~ are parallel to the ~urface, ~ome are oblique, esp~c~ally anteriorly A
posterior limitlng lamina 34 1- referred to a~ De~cemet~
membrane It 1~ a ~trong membrane ~harply defined from the ~troma 32 and resl~tant to pathologlcal ~ r~ of the co~n~-.
~ he enAo~h^lium 36 1~ the mo~t po~terlor layer of the corn-~ a~d consl~t~ of a slngle layer of cell~
which aid in ~nta~n~ng the transparency of the ro~n^-The l~mbu~ 37 i~ the tran~ltion zone betwee~ thecon~u~ctlva 38 and ~clera 13 on the one hand and the cornea 12 o~ the other A cros~ ~ectlonal vlew of an lntra~tromal-corn~-l ring ~7 of the inventio~ iJ 8hOWn wlthin the ~troma 32 of the rorn~a 12 The r$ng ~7 i~ ~lac~ in the - - 2~7~1 W094/~ PCT/US93/~7~
Jtroma 32 by making an initial inci-ion into the cornea 12 and then ro~t~n~ng to ~qp~rrte the ~troma of the corne~ in a circular directi from the in$tial lnciJion be~eath the 8urface of the corn^- 80 a~ to provide a compl~t- -nnlll rr rhanne~ wlthln the cor~ea 12 The ring 47 i8 pl~cs~ ~ithin the nn-ll ar chaDnel Plgure 3 shows the globe of the eye having a rorn^- with a normal curvature 41 If parallel ray~ of llght pas~ through the c~_ e-l urface ~1 of ~$gure 3, they are refracted by the corneal ~urfaces to converge eventually near the retina of the ey- The diagram of P~gure 3 di~co~nt-, for the purpo~es of thiJ ~ lon, the refractlve effect of the lens or other portions of the eye The eye deplcted in Pigure ~ i8 myopic The corneal curvature 43 cause~ the light ray~ to refract into focu~ at a point in the ~itreou~ body whlch i~ ~hort of the retinal surface If an ICR i~ implant~ into the chord of the rorne~ such that the radiu~ of curvature of the corne- 1~ uniformly increased, the central curvature of the cornea i~ flattened ~ight ray~ refracted by the now flattened corne-l surface will be refrarte~ at a smaller angle and thus converge at a more distant point ~uch a8 directly on the retina The ICR~ of the present invention make lt possible to ad~ w t the radius of curvature of the cornea without adver~ely affectlng its natural sphericity Wher- there i~ ~eriou~ a~tigmatism, the natural sphericity will not be altered ~uch that the astigmatism will be ~ignificantly increased ~cA~vær, where there i~
~ignifica~t a~tlgmatl~m that result~ in impaired ~ls$on, the ICR of the i~vention may actually improve the sphericity to reduce such astigmatism and i~r~e vislon AJ 18 shown in Pigures 3 and ~ by changing the curvature from a curvature 43 to a curvature ~1 the focal point can be correctly positioned on the retina A omall 2 ~
W094/0~4 PCT/US93/~7~
degr-e of curvature cha~ge can aff-ct the focal point of th l~ght entering the eye Accordingly, it i- difficult tQ choo~e the co~sect thickne~J of an ~ntrastrcnal corneal ring to be inserted ln the troma of tbe cornea
5 80 that it ~ill ~o.-e~ly affect the focal point of the light enter~ng the eye The dlfficulty wlth respect to choo~ing the cGLLect thicknes~ i~ the point where the ad~antage- of the present invention become moct apparent When the pre~ent ln~ention 1~ u~ed the intrastromal corneal ring i~ flrst ad~usted to have a thicknes~ which is believed to be the co~.e-t thicknes~ ~owever, after ins-rting the rlng ~nto the stroma of the corne~ the thlcknes~ of the ring can be further ad~u~ted in order to pr-ci-ely focu~ the llght entering the eye on the retina A~ ~hown in ~igure 2, a~ intra~tromal corne~l ring (ICR) ~7, hav$ng a cro~ ~ect~Qn~l shape a~ ~hown in ~lgure 6~ i~ Jhown im~lant~ in th stromal layer of the cornea The thicknes~ of the ring can be ad~usted prior to plac~ng the ring in the eye Preferably the ring thir~n~ can be further ad~usted i~ to precisely ad~ust the amou~t of correctio~ necessary ~y such ad~u~tment~ the rays refracted by the ~orne~ and other eye ~ t~ can be ~rought to focu~ directly on the retina (not ~hown in ~igure 2) Pigure 5 shows a ~F ~_yE_~i~e ~iew of the ICR 47 with it~ th~ ^A height ad~ustment mean~ i~ inserted within a cornea 50 of a human eye In the embodiment ~hown withln ~igure 5, the ICR i~ place~ in a manner such that the widest faces 51 and 52 face outward along the li~e of ~ight 53 and away from the eye, wherea~ the narrower face~ 5~ and 55 face raA~al~y inward toward the ~n~-- of th eye and the wide a~d narrow face~ are perpendicular to each other ~owe~er, it ~ho~ be noted that other configuration~ are possible Height or 21~761 W094/~ PCT/US93/~7 thicknes- ad~ w tment i~ carried out by ~crewing the threadod body members 47' and ~7~ Jo that they move away from or toward ~ach other depen~n~ on whether an increa~e or d~crea~- in thicknes- i~ required A plane ~iew of the IC~ ~7 of the lDventio~ i8 ~hown in ~igure 6A AJ shown, the lC~ iJ c$rcular in shape and iJ compr~sed of two elongated, flexible body member~ 47~ and 47~ each of which form~ a circle One pos~ible crosJ Jectional conflgur-t~ 9n i~ ~hown in Flgure 6B which conflguratio~ iJ ba~ically rectangular Yith angled outer edge~ Other cro~J Ject~s~al conf~guratlonJ are po~sible, ~uch a~ ~quare, circular, and variatio~s therebetween ~?cal~F~ the body of the rlng i~ clrcular, it ha~ the ~ame dlameter D in all dlrectlonJ Howe~er, lt i8 possible to configure the body of the ring in other ~llghtly n~nc~rcular conflgur-t~o~-, e.g., o~alJ and elo~gated ovals.
~owever, in thes- conflgurat~n~ th two ring~ ar not interro~nq_~ed by threa~ng but by other ad~ustable means such a~ r-trheA ~lot~. In ltJ preferred circular configuratlon, the diameter co~forms to the size of a human corn6- whlch is a~Lo~lmately 1 cm in diameter.
The rlng 1~ comprised of a biocompat~hle materlal such as a biocolpatible polymer. Such blocompatlble materlale and polymer~ are partlcularly deslgned wlth eye tl~sue charact-ri~tlc~ in mlnd. Accordingly, materlal~ such a~
those w ed ln maklng ro~tact lenses can be u~ed. It i8 po~teA out that the o~l~r tlssue~ 1~ generally gulte ~en~ltl~e and may react upon the l~rl~nt~tlon of the ring. ~ow~ver, after a perlod of time, any lnflammatlon and/or ad~er~e reaction will be ellmlnated. In order to decrease the pr~hah~l~ty of adver~e reactlon~, ~t 1~
de~lrabl- to choo~e a blocomFat~hle materlal ~hlch ~111 not create au lmmu~e reactlon, be no~toY~ and biologically be~ign. Metal~ an~ metal alloy~ are 21~47~ 1 W094/~ PCT/US93/~
generally undesirable a~ are other type~ of materials wh$ch react with the o~ l ar tis~ue The ring~ 47~ an~ 47~ in Pigure 6A each how one ~nd ~8 and 50 Becaus- Pigur- 6A i~ a plan~ ~iew, the ends 48 and 50 are each hown a~ a ingle line The other end~ ~9 and 51 are each shown by a dotted line in that thi~ end i~ vi-ible only from the other side of the ring~ 47' and 47~ The corresp~nA~n~ ends 48 and 49 and ~3~lc~po~A~ng end~ 50 and 51 may bQ tructured in several different configurations, a~ di~ q~ in connection with Pigure~ 13 and 6A
A~ shown in ~igures 6A and 13, the corresponA~n~ ends 48 and 49 are overl~ppi~g each other a~ the endJ 50 and 51 The rlng~ can be s~L~d toward each other as shown by the arrows f or in the opposite direction a~ shown by the arrow~ f~
The thickness of the ring may be between ad~u~ted with$n a range of about 0 05 mm and 1 5 mm Such a ring pl~c9~ a~ oAlmately at the 8 mm chord of the cornea pro~$de~ a means for making such a cG~ec~i~e ad~ustment A~ indicated above PigureJ S and 6A ~how an ICR
of the invention which i~ comprised of a generally circular body member The ring i~ comprioed of a material which ha~ sufficient stiffness to m~nta~n its generally circular shape The material ~hould have properti-~ that render it physiologically compatible with the tissue of the cQrne~ An illustrative material is a plaotic type material sold under the trade name of pr~YT~ g~, however many other biocompatible polymers are u~eful in the invention, including but not l~mited to polyolefino (e g , polypropylene and polybutyle~e), polyc~rh~teo, acrylic re~ins (e g , acrylateo and m,ethacrylat-J, including polymethylmethacrylate (PMM~) and polyL~l~uA~ethyl methacrylate (polyHEMA)), poly-- 21~47~1 W094/~ PCT/US93/~7 ac-t~lJ, polyester~, polyamides (e.g., nylo~), polyure~h-~ ~, epoxy resin~, Jllicones or other natural or Jynthetic rubber~, copolymerJ that are composed of hard and oft ~egment- (e.g., ~YT%E~ rr~t, Wilmington, D~), polytetrafluoroethylene (PTF~), polyvinyl-y~ olidone, polyethers/ether keto~e~, polysulfones, glas~, and copolymers (dlscrete or hlork), blendJ and m~xture~ of the above. As dl~ e~ above, the means of ad~ustlng rlng thir~n~q can vary. When a cross section of the ring i8 circular, it i8 generally dimensioned to be about 0.05 mm to 1.5 ln thlckne~.
A particular cro~s sectional configuration is chematically ~hown in Flgure 6B. When thi~
configuration i~ used, the dlmen~lon shown from polnt to polnt (~men~ion x) may be wlthln the range of a~Almately 0.25 mm to 3.25 mm and the th~r~n~7 (dlm~nslon y) generally can be ad~usted in the range from about 0.05 mm to about 1.5 mm.
There are a number of factor- which affect the degree of flatte~ing of the cornea obtalned ~epcr~ng upon the thir~ne~- of the ring belng lnserted.
Accord$ngly, it i~ not alway~ possible to ~ e a d$rect relatlo~-h~p between the rlng th~r~nes~ and the degree of flate~t ng and therefore the cha~ge in focal polnt.
VarlatlonJ are r?~ by factor~ ~uch as the type of mammal ln ~h$ch the rlng i8 be$ng inserted and the slze and shape of the eye. ~ow~ver, ln certaln experiments, it ha~ been found that optical correction~ can be carried out at the rate of 1 diopter of flatten~g for each 0.02 mm $~crease ~n ICR thlr~n6~E ~hen the ~lze of the ICR la in the range of about 0.26 mm to about 0.46 mm in th$r~n6^7. ThU8, it i~ advantageous to ~et the thre~ng on the lnterconn~ted ring 80 that one 360-, 180-, or 90 tur~ of one ring relatlve to the other changes the thicknes~ by 0.02 mm. Alternatlvely, in a ratched 21~47~1 WO 94/06504 PCr/USg3/08766 ~ bo~iment one increment change w$11 change th thi~re 6-by 0 02 mm or ~ome fraction or multiple thereof ~ ven where the eye i- not myoplc, the ICRs of the preJent invention may be useful to alleviate exces-i~e a~tigmati~m A typical panel of ICRJ ~ill conJi~t of S ICas with the following thir~n~r~-s 0 25 mm, 0 30 mm, 0 35 mm, 0 40 mm an~ 0.45 mm. The c~.~e~Live refraction for tho~e ICR~ are as follows between 0 5 and 3 0 dlopter~ for the 0 25 mm ICR, between 1 0 and 5 O
diopter~ for the 0 30 mm ICR, between 2 0 and 8 0 diopter~ for the 0 35 mm ICR, between 3 0 and 10 0 d~opter~ for the 0 40 mm ICR, and betw~en 4 0 and 15 0 diopters for the 0 45 mm ICR It -h~ be noted that these valuen are for cG~e~tional ICR8 and that value of between O.S to 18.0 might be used. The amount of corrective refraction for the variou~ thicknesse~ of ICRs of different cross ~ect~nal ~h~pq~ ring~ may differ from those values.
The a~eence of the present invention lies in the ability of the ring to be adiusted in thicknes~ 80 that it i~ not necesDary to stock a plurality of different rings of different size~ to be used in c~nne_tion wlth the method for ad~usting the shape of the cornea of an eye. Accordingly, the present lnvention provides a plurality of different embodl¢ents of ICRs which are each ad~ustable in terms of their thlckness.
The thi~n-~n- ad~u tment may occur prior to the in~ertion of the ICR into the cornea and may not be further ad~ustable after ~n-_-Lion. ~owever, in the preferred ~A~ment~ of the inven~sn the IC~ i~ lnserted at a thlr~n-~r which i~ believed to be proper and may be adju~ted thereafter in order to precinely define the desired thicknenn and thereby more preci~ely ad~u~t the W094/0~ 2 ~ ~ 1 7 ~ 1 PCT/US93/~7~
~hape of the rorne- and focus the light entering the eye on the retina.
The ICR is inserted into the corneal atroma of the eye through an oblique keratotamy incision pl~ce~
S peripherally into the cornQrl stroma. The ~ze of the insertion will vary ~omewhat depending on factors ouch a~ ~
the size of the ring or rings being inserted. In general, the ~ize of the insertion iJ ay~ G~lmately 0.5 mm to 5.0 mm in length w~th a~ inci~ion of a~r~imately 2.5 mm being typical. Prior to ring insertion, a rh~anneling blade i8 inserted at the depth of the inci~ion and a circular rhann~ cut into the corne_l ~troma. Proper centering of the cut i~
accompli~hed by use of a centering device that aligns the rhan~^ling blade. The ring i~ then in~erted and the ends are ~ecured by fastening one end to the other.
rC~eC1 f~ C Preferr~t~ RmhC'~ m~nt~
Bight different basic preferred embodiment~ are shown in Pigure~ 7-15. In addition, m_ny of the basic embodiment- are further illustrated by meanJ of subembodiment~ which include, for example, different configurations of the cross sectlonal parameter of the ring. It i~ mpha~ized that each of the embodiments and ~ube~bodiments may be interchanged and be co~prised of different material~ and pro~ided in different sizes in accordance with the ~ize limitationJ indicated above.
Purther, the di~closures of these different embodiments may demon~trate to others skilled in the art that other embodimQnt~ are possible which provide substantt~lly the ~ame result~ in term~ of providing a ring structure which i~ ad~ustable in term~ of it~ thickness.
A ratched helght ad~us~m~nt embodiment i~ shown in Flgures 7A and 7B. Cros~ sectional ~iews of the e~h~ent in different relative positions to create - ~14~761 WO94/~ PCT/US93/~7 thickne~ varlation~ are shown in Figure- 7A and 7~ The lower ring 70 i~ su.~o~ d by the outer upper ring 71 and the two rings are inte~o~uected by mean~ of ratched ~lot~ 72 and 73 and protuberance~ 74 and 75 ~he protuberanceJ 7~ and 75 fit wlthin the ~lots 72 and 73 respectively The ring 71 can be pulled upward in the directlon of the arrow f ln order to repositlon the prot~ rance~ 74 and 75 aJ ~hown wlthin Flgure 7~ In the configurat~on ~hown ~ithln Flgure 7B the thir~nee- of the dual ring structure i8 increased as compared w~th the thicknes~ of the ~tructure poJltioned a~ per Flgure 7A
ThlJ embodi_e~t i~ simpl- to produce and provide~
deslrable re~ult~ aJ compared wlth the use of a multiplicity of dlfferent ring~ However, the em~c~ment iJ not de~irable in that it i8 omewhat difflcult to ad~ust the thickness of the ring~ after the rings have been ln~erted within the L~
In ~lgure 8A the rlngs 80 and 81 are shown in a cros~ sectlonal vlew The inner ring 80 include~
thre~ gs 82 on lts outer circumfere~ce while the ring 81 lnclude~ thread~ngs 83 on lt~ in~er circumference The thre~ng~ 82 and 83 mesh lnto each other and the ringJ 80 and 81 can be turned in dlrections opposi~-e to each other In the position shown in Figure 8A the rings have been t~rn~ ~o that the ring 81 ha~ been increased in height relatlve to the ring 82 thereby lncrease the thi~n~7 ThiJ height ad~ustment can be carried out i~
~-In Flgure 9A the ring 90 i~ ~ub~ant~ y deflated i~ that no fluid ha~ been in~ected lnto the ring~ia the nozzle 91 In Figure 9B the rlng 90 has been ~ubst~nt~ y inflated by the ln~ection of a fluid into the ring 90 via the ~ozzle 91 By in~ecting the fluld into the ring the thickne~s of the ring i~ lncreased It 1~ also po~sible to design the ri~g ~uch that it~ outer 2:1 ~ 57~
WOg4/~ PCT/USg3/087 end or in~er diameters are also increa~ed with the in~ection of fluid. mere are two -parate subemkodiment- of the inflatable ring which can provide particular advantages. In a first ~h~odiment, the ring $8 deslgned 80 that when it i- ~nflated it will only lncreasQ in thir~ne7q and not lncrease r-~ally. In the _ con~ ~ubambodiment, the ring i- de-igned such that when it 1~ inflated, it will not increas- in thir~n-o- but only increase ra~ally. It i8 possible to design a cross breed subembodiment which allows a certain, predetenmined degree of thickness increase and a certain, predetPr~ ne~
degree of radial increase, each within ~pecific limitationJ de~igned to obtain a specific effect. me nozzle 91 is preferably a chcck ~al~e, i.e. one-way valve which allow~ a fluid to be $n~ected in but which will not allow a fluid to flow out. However, fluid could be extracted by in~erting a hypodermic needle into the valve qren~ and vacuuming fluid from the interior of the ring 90. A~ ~hown within Figure 9A the valve 91 i~ preferably positioned on a separate piece 92 which can then be completely encom~a~ by and sealed with respect to the outer wall~ of the ring 90. Howe~er, other embod~m~nts are possible. me material in~ected into the ring 90 can be any suitable material including water and biocompatible liguids and gels. Por ~Y~rle, see the gel in~ection syotem disclosed within U.S. Patent 5,090,955 ~r-~ Pebruary 25, 1992 which i8 in~o~yo-ated herein by reference.
I~ Plgure 9A a method for including the infl~ahle ring 90 into the ro~ne~ of the eye is shown.
~n essence, the ring 90 is rl~cq~ on a blade 93 which has a blade width ay~ Lmately equal to or slightly larger than the internal di_meter of the rlng 90. ~he point 94 of the hl~ cuts annol~rly into the cQrn~a followed by the ring 90. When a complete circular ~ncision i~ made 21~7~1 W094/~ PCT/US93/~7~
the entire ring 90 i- lnsert~d ~ithin that incision.
Thereafter, by holding the ring 90 in place the hl~A- 93 can b~ withdrawn l-a~ing the ring 90 in place.
Ther~after, the interrrnn~ctor inclu~ng th zzl- 91 $~
insQrted $nto one end of the rlng and therQafter into the other ring in order to form a cc~plete clrcle.
A cros- section of a tube centered embodiment i8 shown Figur- 10 wherein the upper ring 100 is separated from the lower ring 101 by a tube 102. In that the ring iJ ~l-ce~ ~ithin a relatively small incision ~ithin th o~)lar tissue, the comFo~6nt~ of the ring will be held together by the ~ e provlded by the ocular ti_sue. Accordingly, there i8 generally no need to provide any additional force~ to bring the comF~n^nt~
together. However, the two ring~ can be held together by a supplemental means including by the inclusion of magnetic material ~ithin both of the rings.
Alternati~ely the tube 102 may be comprised of a magnetic material and the rings 100 and 101 may include a material ~uch a~ iron ~hich i~ attracted by the magnetic material.
In accordance with this embodiment the thic~reQ- of the overall ring structure i~ increaoed by increasing the oize of the tubes 102 which are included between and separate the ring~ 100 and 101.
Figures llA and llB provide perspecti~e viewo of the notched em~Q~ent of the invention. In ~igure llA the notche~ of the ring~ 111 and 112 are intenme~hed to provide the th~nneQt possible r$ng ~tructure. In Figure llB the notches are aligned co as to provide the 30 ~aximum thic~ne~. This embodiment may be ea_ily constructed. ~c__~cr, it has disadvantage~ in that the ad~uotment i~ only in a ~ingle increment. This can be arco~nted for to a certain extent by including a plurality of notches of different height~ and aligning the de~ired height notch in order to achieve the de~ired 21f~76~
W094/~ PCT/US93/~7 thickn~ and thereafter l~r~ n~ the ri~g~ into place by any ~ppropr~ate meaD~ ~uch a- the u~ of ~uture-, adhesive~, pinJ, etc Figure~ 12A and 12B hows a smooth urface interlo~n~ embodiment In Figure 12A the ring~ are intermeshed Jo as to provide the thiD~est poo^~hle 8tructure wherea~ ~igure 12~ showJ the thicker structure Due to the smooth ~urfaces of the interlork~n~ compon~nt~
it i~ possible to vary the height of the ring~ and when the desired height i8 achieved lock the rings into place by an a~-G~liate means such a- the use of an adhesive or suture~
In all or any of the above embodlments variationJ are possible with ~ _~ecL to the cross ~ectional configuratlon of the ring-, the type of material a~d other parameters For example, all of the ring structure~ how~ abcve must be open enA~ ring~ 80 that they can be inserted into the rorne- via an entry incislon and then fed around a circular incislon s de in the ro~n-- The ~ndJ may then be interco~nected to each other Thi~ can be done in a variety of way~ For eY~ple, the use of two ring~ make~ it possible for each of the ring~ to act a- a clo~ur- mean~ for the other when the ring~ are rotated relat$Ye to each other ~o that their endJ are not aligned This can be done after in~erting the ring~ in the eye When two r$ng~ are not n~ (e g the inflatable embodiment) the endJ of the ring can be interconnected aJ ~hown in Figure 13 Pigure 13 ~hows a tapered overlapping conflguration The tapered effect~ of the ends 130 and 131 i~ dramatically ~hown wlthin Pigure~ 13 and 13~ One end 130 gr~ y narrows at the ~ame rate that the end 131 narrow~ The ends 130 and 131 are held together by hor~ tal ~d vertical force vectors which oppo~e each other and are ~hown a~ hf, hf', ~f and vf' as show~ in 2~'i76~
W094/~ PCT/US93/~7 Figur- 13A The cross sectional ~tructure of the ring can be circular a- indicated by the different configuration~ in Figures 13~, 13C and 13D However, a~
~hown in the~e figure- the man~er in ~h~ch the end~ 130 and 131 fit together along their ad~acent surface~ can vary from the plan~r interconnection of ~igure 138 to the curved plane of Figure 13C and th F~-~e~ intercon~ection of Pigure 13D A cros- aection i~ ~hown in Figure 13B
In Figure 14A a stacke~ shi~ embodiment is shown The embodiment include~ at least a lower disk 140 and an upper disk 141 Bach of the disk~ ha~e ~p~n~ng8 in their center The lower disk 140 may include a raA~ y r-~-e~ area (not ~hown) protruding upwardly This raised area fitJ within an ~n~-nt~tlon (not shown) in the upper disk Bach of the dls~J are open ended, i e they are not continuow but have endJ 142 The multiple disks 140 and 141 may be ~tacke~ on top of each other and i~erted into the corn^-, a~ shown withi~
Pigure 14B Thereby, the ~ize of the ring ctructure inserted into the eye can be increased in thicknesa to any degree Figure 15A shows a spiral ~hap~ sprlng ~mbodimQnt of the lDvention Thi~ embodiment i~
~ ised of a ~ingular spiral or sprlng ehape~ piece of material 150 A~ shown within Figure 15B the end of the spiral i~ inserted into the ann~ r ch-nnel formed in the cornea and et into the chann~l The device is co~t~n~ y fed into the rhann~l in a manner such that each circular movement of the ~pri~g ~ill cau~e another layer to be ~d~ed msking it po~sible to increase thicX~e~J to any desired amount When the desired amount of thir~ne~- is cbta~n ~, the material i~ cut The spiral ring 150 can be deslgned in a variety of dlfferent ways Por -Ya~ple~ the ring can be designed ~o that each 35 ~ucc6~'ive ring has the same diameter and fitJ tightly 21~7~
wo ~/~ ` PCT/US93/~7 aga~t the next rlng When th~- haped device 1J u~ed, the rorr~- iJ lncreased in thickneJ~ aJ additional layer~
a~e -dA~ but is not increa~ed r ~ally In another ~mbod1ment, the ~prlng-shaped piece of material 150 can S be designed o that each successi~e ri~g i- ~lightly larger in diameter Thereby, i~crease~ in the diameter of the inserted ring can be rh~n~ by including additional rings into the cornea ~odifications of the above described modes for carrying out the invention may occur to persons of skill in the field~ of medicine, ophth-l logy, optometry a~d/or related field~ upon rea~g the disclosure and are all ~nte~~d to be within the ~cope of the following claim~
~owever, in thes- conflgurat~n~ th two ring~ ar not interro~nq_~ed by threa~ng but by other ad~ustable means such a~ r-trheA ~lot~. In ltJ preferred circular configuratlon, the diameter co~forms to the size of a human corn6- whlch is a~Lo~lmately 1 cm in diameter.
The rlng 1~ comprised of a biocompat~hle materlal such as a biocolpatible polymer. Such blocompatlble materlale and polymer~ are partlcularly deslgned wlth eye tl~sue charact-ri~tlc~ in mlnd. Accordingly, materlal~ such a~
those w ed ln maklng ro~tact lenses can be u~ed. It i8 po~teA out that the o~l~r tlssue~ 1~ generally gulte ~en~ltl~e and may react upon the l~rl~nt~tlon of the ring. ~ow~ver, after a perlod of time, any lnflammatlon and/or ad~er~e reaction will be ellmlnated. In order to decrease the pr~hah~l~ty of adver~e reactlon~, ~t 1~
de~lrabl- to choo~e a blocomFat~hle materlal ~hlch ~111 not create au lmmu~e reactlon, be no~toY~ and biologically be~ign. Metal~ an~ metal alloy~ are 21~47~ 1 W094/~ PCT/US93/~
generally undesirable a~ are other type~ of materials wh$ch react with the o~ l ar tis~ue The ring~ 47~ an~ 47~ in Pigure 6A each how one ~nd ~8 and 50 Becaus- Pigur- 6A i~ a plan~ ~iew, the ends 48 and 50 are each hown a~ a ingle line The other end~ ~9 and 51 are each shown by a dotted line in that thi~ end i~ vi-ible only from the other side of the ring~ 47' and 47~ The corresp~nA~n~ ends 48 and 49 and ~3~lc~po~A~ng end~ 50 and 51 may bQ tructured in several different configurations, a~ di~ q~ in connection with Pigure~ 13 and 6A
A~ shown in ~igures 6A and 13, the corresponA~n~ ends 48 and 49 are overl~ppi~g each other a~ the endJ 50 and 51 The rlng~ can be s~L~d toward each other as shown by the arrows f or in the opposite direction a~ shown by the arrow~ f~
The thickness of the ring may be between ad~u~ted with$n a range of about 0 05 mm and 1 5 mm Such a ring pl~c9~ a~ oAlmately at the 8 mm chord of the cornea pro~$de~ a means for making such a cG~ec~i~e ad~ustment A~ indicated above PigureJ S and 6A ~how an ICR
of the invention which i~ comprised of a generally circular body member The ring i~ comprioed of a material which ha~ sufficient stiffness to m~nta~n its generally circular shape The material ~hould have properti-~ that render it physiologically compatible with the tissue of the cQrne~ An illustrative material is a plaotic type material sold under the trade name of pr~YT~ g~, however many other biocompatible polymers are u~eful in the invention, including but not l~mited to polyolefino (e g , polypropylene and polybutyle~e), polyc~rh~teo, acrylic re~ins (e g , acrylateo and m,ethacrylat-J, including polymethylmethacrylate (PMM~) and polyL~l~uA~ethyl methacrylate (polyHEMA)), poly-- 21~47~1 W094/~ PCT/US93/~7 ac-t~lJ, polyester~, polyamides (e.g., nylo~), polyure~h-~ ~, epoxy resin~, Jllicones or other natural or Jynthetic rubber~, copolymerJ that are composed of hard and oft ~egment- (e.g., ~YT%E~ rr~t, Wilmington, D~), polytetrafluoroethylene (PTF~), polyvinyl-y~ olidone, polyethers/ether keto~e~, polysulfones, glas~, and copolymers (dlscrete or hlork), blendJ and m~xture~ of the above. As dl~ e~ above, the means of ad~ustlng rlng thir~n~q can vary. When a cross section of the ring i8 circular, it i8 generally dimensioned to be about 0.05 mm to 1.5 ln thlckne~.
A particular cro~s sectional configuration is chematically ~hown in Flgure 6B. When thi~
configuration i~ used, the dlmen~lon shown from polnt to polnt (~men~ion x) may be wlthln the range of a~Almately 0.25 mm to 3.25 mm and the th~r~n~7 (dlm~nslon y) generally can be ad~usted in the range from about 0.05 mm to about 1.5 mm.
There are a number of factor- which affect the degree of flatte~ing of the cornea obtalned ~epcr~ng upon the thir~ne~- of the ring belng lnserted.
Accord$ngly, it i~ not alway~ possible to ~ e a d$rect relatlo~-h~p between the rlng th~r~nes~ and the degree of flate~t ng and therefore the cha~ge in focal polnt.
VarlatlonJ are r?~ by factor~ ~uch as the type of mammal ln ~h$ch the rlng i8 be$ng inserted and the slze and shape of the eye. ~ow~ver, ln certaln experiments, it ha~ been found that optical correction~ can be carried out at the rate of 1 diopter of flatten~g for each 0.02 mm $~crease ~n ICR thlr~n6~E ~hen the ~lze of the ICR la in the range of about 0.26 mm to about 0.46 mm in th$r~n6^7. ThU8, it i~ advantageous to ~et the thre~ng on the lnterconn~ted ring 80 that one 360-, 180-, or 90 tur~ of one ring relatlve to the other changes the thicknes~ by 0.02 mm. Alternatlvely, in a ratched 21~47~1 WO 94/06504 PCr/USg3/08766 ~ bo~iment one increment change w$11 change th thi~re 6-by 0 02 mm or ~ome fraction or multiple thereof ~ ven where the eye i- not myoplc, the ICRs of the preJent invention may be useful to alleviate exces-i~e a~tigmati~m A typical panel of ICRJ ~ill conJi~t of S ICas with the following thir~n~r~-s 0 25 mm, 0 30 mm, 0 35 mm, 0 40 mm an~ 0.45 mm. The c~.~e~Live refraction for tho~e ICR~ are as follows between 0 5 and 3 0 dlopter~ for the 0 25 mm ICR, between 1 0 and 5 O
diopter~ for the 0 30 mm ICR, between 2 0 and 8 0 diopter~ for the 0 35 mm ICR, between 3 0 and 10 0 d~opter~ for the 0 40 mm ICR, and betw~en 4 0 and 15 0 diopters for the 0 45 mm ICR It -h~ be noted that these valuen are for cG~e~tional ICR8 and that value of between O.S to 18.0 might be used. The amount of corrective refraction for the variou~ thicknesse~ of ICRs of different cross ~ect~nal ~h~pq~ ring~ may differ from those values.
The a~eence of the present invention lies in the ability of the ring to be adiusted in thicknes~ 80 that it i~ not necesDary to stock a plurality of different rings of different size~ to be used in c~nne_tion wlth the method for ad~usting the shape of the cornea of an eye. Accordingly, the present lnvention provides a plurality of different embodl¢ents of ICRs which are each ad~ustable in terms of their thlckness.
The thi~n-~n- ad~u tment may occur prior to the in~ertion of the ICR into the cornea and may not be further ad~ustable after ~n-_-Lion. ~owever, in the preferred ~A~ment~ of the inven~sn the IC~ i~ lnserted at a thlr~n-~r which i~ believed to be proper and may be adju~ted thereafter in order to precinely define the desired thicknenn and thereby more preci~ely ad~u~t the W094/0~ 2 ~ ~ 1 7 ~ 1 PCT/US93/~7~
~hape of the rorne- and focus the light entering the eye on the retina.
The ICR is inserted into the corneal atroma of the eye through an oblique keratotamy incision pl~ce~
S peripherally into the cornQrl stroma. The ~ze of the insertion will vary ~omewhat depending on factors ouch a~ ~
the size of the ring or rings being inserted. In general, the ~ize of the insertion iJ ay~ G~lmately 0.5 mm to 5.0 mm in length w~th a~ inci~ion of a~r~imately 2.5 mm being typical. Prior to ring insertion, a rh~anneling blade i8 inserted at the depth of the inci~ion and a circular rhann~ cut into the corne_l ~troma. Proper centering of the cut i~
accompli~hed by use of a centering device that aligns the rhan~^ling blade. The ring i~ then in~erted and the ends are ~ecured by fastening one end to the other.
rC~eC1 f~ C Preferr~t~ RmhC'~ m~nt~
Bight different basic preferred embodiment~ are shown in Pigure~ 7-15. In addition, m_ny of the basic embodiment- are further illustrated by meanJ of subembodiment~ which include, for example, different configurations of the cross sectlonal parameter of the ring. It i~ mpha~ized that each of the embodiments and ~ube~bodiments may be interchanged and be co~prised of different material~ and pro~ided in different sizes in accordance with the ~ize limitationJ indicated above.
Purther, the di~closures of these different embodiments may demon~trate to others skilled in the art that other embodimQnt~ are possible which provide substantt~lly the ~ame result~ in term~ of providing a ring structure which i~ ad~ustable in term~ of it~ thickness.
A ratched helght ad~us~m~nt embodiment i~ shown in Flgures 7A and 7B. Cros~ sectional ~iews of the e~h~ent in different relative positions to create - ~14~761 WO94/~ PCT/US93/~7 thickne~ varlation~ are shown in Figure- 7A and 7~ The lower ring 70 i~ su.~o~ d by the outer upper ring 71 and the two rings are inte~o~uected by mean~ of ratched ~lot~ 72 and 73 and protuberance~ 74 and 75 ~he protuberanceJ 7~ and 75 fit wlthin the ~lots 72 and 73 respectively The ring 71 can be pulled upward in the directlon of the arrow f ln order to repositlon the prot~ rance~ 74 and 75 aJ ~hown wlthin Flgure 7~ In the configurat~on ~hown ~ithln Flgure 7B the thir~nee- of the dual ring structure i8 increased as compared w~th the thicknes~ of the ~tructure poJltioned a~ per Flgure 7A
ThlJ embodi_e~t i~ simpl- to produce and provide~
deslrable re~ult~ aJ compared wlth the use of a multiplicity of dlfferent ring~ However, the em~c~ment iJ not de~irable in that it i8 omewhat difflcult to ad~ust the thickness of the ring~ after the rings have been ln~erted within the L~
In ~lgure 8A the rlngs 80 and 81 are shown in a cros~ sectlonal vlew The inner ring 80 include~
thre~ gs 82 on lts outer circumfere~ce while the ring 81 lnclude~ thread~ngs 83 on lt~ in~er circumference The thre~ng~ 82 and 83 mesh lnto each other and the ringJ 80 and 81 can be turned in dlrections opposi~-e to each other In the position shown in Figure 8A the rings have been t~rn~ ~o that the ring 81 ha~ been increased in height relatlve to the ring 82 thereby lncrease the thi~n~7 ThiJ height ad~ustment can be carried out i~
~-In Flgure 9A the ring 90 i~ ~ub~ant~ y deflated i~ that no fluid ha~ been in~ected lnto the ring~ia the nozzle 91 In Figure 9B the rlng 90 has been ~ubst~nt~ y inflated by the ln~ection of a fluid into the ring 90 via the ~ozzle 91 By in~ecting the fluld into the ring the thickne~s of the ring i~ lncreased It 1~ also po~sible to design the ri~g ~uch that it~ outer 2:1 ~ 57~
WOg4/~ PCT/USg3/087 end or in~er diameters are also increa~ed with the in~ection of fluid. mere are two -parate subemkodiment- of the inflatable ring which can provide particular advantages. In a first ~h~odiment, the ring $8 deslgned 80 that when it i- ~nflated it will only lncreasQ in thir~ne7q and not lncrease r-~ally. In the _ con~ ~ubambodiment, the ring i- de-igned such that when it 1~ inflated, it will not increas- in thir~n-o- but only increase ra~ally. It i8 possible to design a cross breed subembodiment which allows a certain, predetenmined degree of thickness increase and a certain, predetPr~ ne~
degree of radial increase, each within ~pecific limitationJ de~igned to obtain a specific effect. me nozzle 91 is preferably a chcck ~al~e, i.e. one-way valve which allow~ a fluid to be $n~ected in but which will not allow a fluid to flow out. However, fluid could be extracted by in~erting a hypodermic needle into the valve qren~ and vacuuming fluid from the interior of the ring 90. A~ ~hown within Figure 9A the valve 91 i~ preferably positioned on a separate piece 92 which can then be completely encom~a~ by and sealed with respect to the outer wall~ of the ring 90. Howe~er, other embod~m~nts are possible. me material in~ected into the ring 90 can be any suitable material including water and biocompatible liguids and gels. Por ~Y~rle, see the gel in~ection syotem disclosed within U.S. Patent 5,090,955 ~r-~ Pebruary 25, 1992 which i8 in~o~yo-ated herein by reference.
I~ Plgure 9A a method for including the infl~ahle ring 90 into the ro~ne~ of the eye is shown.
~n essence, the ring 90 is rl~cq~ on a blade 93 which has a blade width ay~ Lmately equal to or slightly larger than the internal di_meter of the rlng 90. ~he point 94 of the hl~ cuts annol~rly into the cQrn~a followed by the ring 90. When a complete circular ~ncision i~ made 21~7~1 W094/~ PCT/US93/~7~
the entire ring 90 i- lnsert~d ~ithin that incision.
Thereafter, by holding the ring 90 in place the hl~A- 93 can b~ withdrawn l-a~ing the ring 90 in place.
Ther~after, the interrrnn~ctor inclu~ng th zzl- 91 $~
insQrted $nto one end of the rlng and therQafter into the other ring in order to form a cc~plete clrcle.
A cros- section of a tube centered embodiment i8 shown Figur- 10 wherein the upper ring 100 is separated from the lower ring 101 by a tube 102. In that the ring iJ ~l-ce~ ~ithin a relatively small incision ~ithin th o~)lar tissue, the comFo~6nt~ of the ring will be held together by the ~ e provlded by the ocular ti_sue. Accordingly, there i8 generally no need to provide any additional force~ to bring the comF~n^nt~
together. However, the two ring~ can be held together by a supplemental means including by the inclusion of magnetic material ~ithin both of the rings.
Alternati~ely the tube 102 may be comprised of a magnetic material and the rings 100 and 101 may include a material ~uch a~ iron ~hich i~ attracted by the magnetic material.
In accordance with this embodiment the thic~reQ- of the overall ring structure i~ increaoed by increasing the oize of the tubes 102 which are included between and separate the ring~ 100 and 101.
Figures llA and llB provide perspecti~e viewo of the notched em~Q~ent of the invention. In ~igure llA the notche~ of the ring~ 111 and 112 are intenme~hed to provide the th~nneQt possible r$ng ~tructure. In Figure llB the notches are aligned co as to provide the 30 ~aximum thic~ne~. This embodiment may be ea_ily constructed. ~c__~cr, it has disadvantage~ in that the ad~uotment i~ only in a ~ingle increment. This can be arco~nted for to a certain extent by including a plurality of notches of different height~ and aligning the de~ired height notch in order to achieve the de~ired 21f~76~
W094/~ PCT/US93/~7 thickn~ and thereafter l~r~ n~ the ri~g~ into place by any ~ppropr~ate meaD~ ~uch a- the u~ of ~uture-, adhesive~, pinJ, etc Figure~ 12A and 12B hows a smooth urface interlo~n~ embodiment In Figure 12A the ring~ are intermeshed Jo as to provide the thiD~est poo^~hle 8tructure wherea~ ~igure 12~ showJ the thicker structure Due to the smooth ~urfaces of the interlork~n~ compon~nt~
it i~ possible to vary the height of the ring~ and when the desired height i8 achieved lock the rings into place by an a~-G~liate means such a- the use of an adhesive or suture~
In all or any of the above embodlments variationJ are possible with ~ _~ecL to the cross ~ectional configuratlon of the ring-, the type of material a~d other parameters For example, all of the ring structure~ how~ abcve must be open enA~ ring~ 80 that they can be inserted into the rorne- via an entry incislon and then fed around a circular incislon s de in the ro~n-- The ~ndJ may then be interco~nected to each other Thi~ can be done in a variety of way~ For eY~ple, the use of two ring~ make~ it possible for each of the ring~ to act a- a clo~ur- mean~ for the other when the ring~ are rotated relat$Ye to each other ~o that their endJ are not aligned This can be done after in~erting the ring~ in the eye When two r$ng~ are not n~ (e g the inflatable embodiment) the endJ of the ring can be interconnected aJ ~hown in Figure 13 Pigure 13 ~hows a tapered overlapping conflguration The tapered effect~ of the ends 130 and 131 i~ dramatically ~hown wlthin Pigure~ 13 and 13~ One end 130 gr~ y narrows at the ~ame rate that the end 131 narrow~ The ends 130 and 131 are held together by hor~ tal ~d vertical force vectors which oppo~e each other and are ~hown a~ hf, hf', ~f and vf' as show~ in 2~'i76~
W094/~ PCT/US93/~7 Figur- 13A The cross sectional ~tructure of the ring can be circular a- indicated by the different configuration~ in Figures 13~, 13C and 13D However, a~
~hown in the~e figure- the man~er in ~h~ch the end~ 130 and 131 fit together along their ad~acent surface~ can vary from the plan~r interconnection of ~igure 138 to the curved plane of Figure 13C and th F~-~e~ intercon~ection of Pigure 13D A cros- aection i~ ~hown in Figure 13B
In Figure 14A a stacke~ shi~ embodiment is shown The embodiment include~ at least a lower disk 140 and an upper disk 141 Bach of the disk~ ha~e ~p~n~ng8 in their center The lower disk 140 may include a raA~ y r-~-e~ area (not ~hown) protruding upwardly This raised area fitJ within an ~n~-nt~tlon (not shown) in the upper disk Bach of the dls~J are open ended, i e they are not continuow but have endJ 142 The multiple disks 140 and 141 may be ~tacke~ on top of each other and i~erted into the corn^-, a~ shown withi~
Pigure 14B Thereby, the ~ize of the ring ctructure inserted into the eye can be increased in thicknesa to any degree Figure 15A shows a spiral ~hap~ sprlng ~mbodimQnt of the lDvention Thi~ embodiment i~
~ ised of a ~ingular spiral or sprlng ehape~ piece of material 150 A~ shown within Figure 15B the end of the spiral i~ inserted into the ann~ r ch-nnel formed in the cornea and et into the chann~l The device is co~t~n~ y fed into the rhann~l in a manner such that each circular movement of the ~pri~g ~ill cau~e another layer to be ~d~ed msking it po~sible to increase thicX~e~J to any desired amount When the desired amount of thir~ne~- is cbta~n ~, the material i~ cut The spiral ring 150 can be deslgned in a variety of dlfferent ways Por -Ya~ple~ the ring can be designed ~o that each 35 ~ucc6~'ive ring has the same diameter and fitJ tightly 21~7~
wo ~/~ ` PCT/US93/~7 aga~t the next rlng When th~- haped device 1J u~ed, the rorr~- iJ lncreased in thickneJ~ aJ additional layer~
a~e -dA~ but is not increa~ed r ~ally In another ~mbod1ment, the ~prlng-shaped piece of material 150 can S be designed o that each successi~e ri~g i- ~lightly larger in diameter Thereby, i~crease~ in the diameter of the inserted ring can be rh~n~ by including additional rings into the cornea ~odifications of the above described modes for carrying out the invention may occur to persons of skill in the field~ of medicine, ophth-l logy, optometry a~d/or related field~ upon rea~g the disclosure and are all ~nte~~d to be within the ~cope of the following claim~
Claims (24)
1. A method for adjusting the shape of the cornea of an eye, comprising the steps of:
cutting an initial incision into the cornea of the eye;
continuing to separate into the cornea of the eye from the point of the initial incision in a circular direction from the incision beneath the surface of the cornea so as to provide a complete annular channel within the cornea;
inserting into the initial incision an end of an intrastromal corneal ring having an adjustable thickness, the ring being comprised of an elongated, flexible annular body;
progressively moving the inserted end of the ring into the initial incision in a circular path within the annular channel until the ring is fully inserted; and adjusting the thickness of the ring and thereby adjusting the shape of the cornea to focus light entering the eye.
cutting an initial incision into the cornea of the eye;
continuing to separate into the cornea of the eye from the point of the initial incision in a circular direction from the incision beneath the surface of the cornea so as to provide a complete annular channel within the cornea;
inserting into the initial incision an end of an intrastromal corneal ring having an adjustable thickness, the ring being comprised of an elongated, flexible annular body;
progressively moving the inserted end of the ring into the initial incision in a circular path within the annular channel until the ring is fully inserted; and adjusting the thickness of the ring and thereby adjusting the shape of the cornea to focus light entering the eye.
2. The method as claimed in claim 1, wherein the ring having an adjustable thickness is comprised of a first and second annular body which are individually inserted into the annular channel and thereafter joined together in manner which provides for relative movement of the body members to allow for adjusting thickness.
3. The method as claimed in claim 1, wherein the ring having an adjustable thickness is comprised of a first and a second annular body member which are joined together in a manner which allows for relative movement of the body members to adjust the thickness of the ring prior to insertion into the annular channel.
4. The method as claimed in claim 1, wherein the ring thickness is adjusted by providing a first body member having threadings on its outer circumference and a second body member having threadings on its inner circumference wherein the threadings on each ring intermesh each other and by turning each ring in a direction opposite to the other ring the thickness provided is changed.
5. The method as claimed in claim 1, wherein the ring includes ends which are each tapered toward a narrow end with opposing ends being tapered in opposite directions such that when the ends fit together they form the substantially smooth and continuous surface.
6. The method as claimed in claim 1, wherein the rings are adjusted by providing a first and a second body member wherein the first body member includes ratched protuberances on its outer circumference and the second body member includes ratched protuberances on its inner circumference whereby the two body members can be intermeshed so that the protuberances on each the body members together and make it possible to adjust the thickness provided by the combination of the two body members.
7. The method as claimed in claim 1, wherein the thickness of the ring is adjusted by injecting a fluid into the ring which ring is comprised of an inflatable open ended body member.
8. The method as claimed in claim 1, wherein the adjustment of thickness is carried out by providing a first and a second body member each of which body member includes protuberances and indentations on a surface which faces the protuberances and indentations of the surface of the other body member so as to allow for thickness adjustment by turning the rings so as to align or misalign the protuberances and indentations.
9. The method as claimed in claim 1, wherein the ring thickness is adjusted by providing smooth continuous peaks and valleys on opposing surfaces of two annular body members, the peaks and valleys being positioned such that the body members can be turned relative to each other so as to adjust the thickness provided by the combination of the body members.
10. The method as claimed in claim 1, wherein the ring thickness is adjusted by providing a coil-shaped ring with a plurality of coils,whereby ring thickness is increased by inserting additional coils of the ring into the cornea until the desired thickness is obtained.
11. The method as claimed in claim 1, wherein the ring thickness is adjusted by providing a plurality of rings into the cornea which rings have surfaces which intermesh with each other whereby rings are inserted until a desired thickness is obtained.
12. An intrastromal corneal ring for refractive correction of a human eye to improve the vision of the eye, comprising:
a first elongated, flexible body member in the form of an open circle; and a second elongated, flexible body member in the form of an open circle wherein the first and second bodies are adjustably interconnected in a manner such that the thickness dimension of the two bodies when interconnected can be changed.
a first elongated, flexible body member in the form of an open circle; and a second elongated, flexible body member in the form of an open circle wherein the first and second bodies are adjustably interconnected in a manner such that the thickness dimension of the two bodies when interconnected can be changed.
13. The intrastromal corneal ring as claimed in claim 12, wherein the ends of the first body member and second body member each have ends which ends overlap and mesh to each other in a manner so as to provide for a smooth and continuous surface.
14. The intrastromal corneal ring as claimed in claim 12, wherein the first and second body members are adjustably interconnected by including a plurality of protuberances on an outer circumference of the first body member and a plurality of protuberances on an inner circumference of the second body wherein the protuberances and circumferences of the first and second body members are designed such that the first and second bodies fit within each other by the intermeshing of the protuberances.
15. The intrastromal corneal ring as claimed in claim 12, wherein the first body member and second body member are adjustably interconnected by providing threads on an outer circumference of the first body member and corresponding threads on an inner circumference of the second body member wherein the threads and diameters of the first and second body members are designed such that the threads interlock each other and when the first body member is moved circularly in a direction opposite to the second body member the thickness dimension is changed.
16. The intrastromal corneal ring as claimed in claim 12, wherein the first body member includes a first surface which faces a second surface of the second body member wherein the first surface and the second surface have corresponding notches and protuberances thereon and the first surface and the second surface are forced together by an attachment means the protuberances and notches being designed such that when the first body member is moved circularly relative to the second body member the notches and protuberances cause the thickness dimension to be changed.
17. The intrastromal corneal ring of claim 12, wherein the thickness of the ICR is adjustable between 0.05 and 1.5 mm.
18. The intrastromal ring of claim 12, wherein the body of the ring has a width in the range of 0.25 mm to 3.25 mm.
19. The intrastromal ring as claimed in claim 12, wherein the ring is comprised of a biocompatible, nontoxic, biologically benign material, has a diameter in the range of 0.5 mm to 10 mm and a thickness in the range of 0.5 mm to 1.5 mm.
20. An intrastromal corneal ring for refractive correction of a human eye to improve the vision of the eye, comprising:
an elongated, flexible, inflatable, annular body member, the inflatable body member having an inflation stem positioned thereon wherein the Inflation stem is designed such that fluid can be injected into the inflatable body so that the thickness dimension of the body is changed.
an elongated, flexible, inflatable, annular body member, the inflatable body member having an inflation stem positioned thereon wherein the Inflation stem is designed such that fluid can be injected into the inflatable body so that the thickness dimension of the body is changed.
21. A mammalian eye, having inserted within its cornea an intrastromal ring which is adjustable in thickness while present within the cornea of the eye.
22. A method for adjusting the shape of the cornea of an eye, comprising the steps of:
providing a coil shaped cutting device and covering the device by progressively moving a hollow intrastromal ring over the cutting device until the entire ring is included on the device with a tip portion of the cutting device extending outwardly from the hollow ring;
cutting an initial incision into the cornea of the eye;
continuing to separate into the cornea of the eye from the point of the initial incision using the point of the cutting device and cutting in a circular direction from the incision beneath the surface of the cornea so as to provide a complete annular channel within the cornea;
holding the hollow ring in place and withdrawing the cutting device from the ring while leaving the ring in place.
providing a coil shaped cutting device and covering the device by progressively moving a hollow intrastromal ring over the cutting device until the entire ring is included on the device with a tip portion of the cutting device extending outwardly from the hollow ring;
cutting an initial incision into the cornea of the eye;
continuing to separate into the cornea of the eye from the point of the initial incision using the point of the cutting device and cutting in a circular direction from the incision beneath the surface of the cornea so as to provide a complete annular channel within the cornea;
holding the hollow ring in place and withdrawing the cutting device from the ring while leaving the ring in place.
23. The method of claim 22, further comprising inserting an interconnector into a first end and a second end of the hollow ring wherein the interconnector device includes an inflation stem having a check valve therein.
24. The method of claim 22, further comprising:
injecting fluid into the inflation stem so as to expand the hollow ring.
injecting fluid into the inflation stem so as to expand the hollow ring.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US07/948,079 US5300118A (en) | 1992-09-21 | 1992-09-21 | Adjustable devices for corneal curvature adjustment |
| US07/948,079 | 1992-09-21 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA2144761A1 true CA2144761A1 (en) | 1994-03-31 |
Family
ID=25487226
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002144761A Abandoned CA2144761A1 (en) | 1992-09-21 | 1993-09-16 | Adjustable devices for corneal curvature adjustment |
Country Status (14)
| Country | Link |
|---|---|
| US (3) | US5300118A (en) |
| EP (1) | EP0660732B1 (en) |
| JP (1) | JPH08504114A (en) |
| KR (1) | KR950703382A (en) |
| CN (1) | CN1091000A (en) |
| AT (1) | ATE183106T1 (en) |
| AU (1) | AU684723B2 (en) |
| BR (1) | BR9307076A (en) |
| CA (1) | CA2144761A1 (en) |
| DE (1) | DE69326011T2 (en) |
| ES (1) | ES2134270T3 (en) |
| IL (1) | IL107037A (en) |
| TW (1) | TW302283B (en) |
| WO (1) | WO1994006504A1 (en) |
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-
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- 1993-09-16 BR BR9307076A patent/BR9307076A/en not_active Application Discontinuation
- 1993-09-16 DE DE69326011T patent/DE69326011T2/en not_active Expired - Fee Related
- 1993-09-16 AU AU49262/93A patent/AU684723B2/en not_active Ceased
- 1993-09-16 EP EP93921633A patent/EP0660732B1/en not_active Expired - Lifetime
- 1993-09-16 WO PCT/US1993/008766 patent/WO1994006504A1/en active IP Right Grant
- 1993-09-16 AT AT93921633T patent/ATE183106T1/en not_active IP Right Cessation
- 1993-09-16 JP JP6508319A patent/JPH08504114A/en active Pending
- 1993-09-16 CA CA002144761A patent/CA2144761A1/en not_active Abandoned
- 1993-09-16 ES ES93921633T patent/ES2134270T3/en not_active Expired - Lifetime
- 1993-09-16 KR KR1019950701097A patent/KR950703382A/en not_active Application Discontinuation
- 1993-09-20 IL IL107037A patent/IL107037A/en not_active IP Right Cessation
- 1993-09-21 CN CN93114099A patent/CN1091000A/en active Pending
- 1993-09-21 TW TW082107755A patent/TW302283B/zh active
- 1993-10-22 US US08/141,813 patent/US5466260A/en not_active Expired - Lifetime
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1995
- 1995-06-06 US US08/467,708 patent/US5693092A/en not_active Expired - Fee Related
Also Published As
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|---|---|
| CN1091000A (en) | 1994-08-24 |
| WO1994006504A1 (en) | 1994-03-31 |
| EP0660732B1 (en) | 1999-08-11 |
| EP0660732A4 (en) | 1995-09-27 |
| KR950703382A (en) | 1995-09-20 |
| IL107037A (en) | 1998-06-15 |
| TW302283B (en) | 1997-04-11 |
| US5693092A (en) | 1997-12-02 |
| US5300118A (en) | 1994-04-05 |
| JPH08504114A (en) | 1996-05-07 |
| DE69326011T2 (en) | 2000-02-24 |
| US5466260A (en) | 1995-11-14 |
| DE69326011D1 (en) | 1999-09-16 |
| ATE183106T1 (en) | 1999-08-15 |
| AU684723B2 (en) | 1998-01-08 |
| EP0660732A1 (en) | 1995-07-05 |
| ES2134270T3 (en) | 1999-10-01 |
| BR9307076A (en) | 1999-06-29 |
| IL107037A0 (en) | 1993-12-28 |
| AU4926293A (en) | 1994-04-12 |
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| Date | Code | Title | Description |
|---|---|---|---|
| EEER | Examination request | ||
| FZDE | Discontinued |