CA1275351C

CA1275351C - Deformable intraocular lens structures and methods and devices for implantation

Info

Publication number: CA1275351C
Application number: CA000420893A
Authority: CA
Inventors: Thomas R. Mazzocco
Original assignee: Individual
Current assignee: Individual
Priority date: 1982-02-05
Filing date: 1983-02-04
Publication date: 1990-10-23
Anticipated expiration: 2007-10-23
Also published as: US4573998A; FR2521002B1; FR2604896B1; JPH04212350A; JPH0558748B2; JPH07163601A; JPS58146346A; AU566203B2; DE3348066C2; FR2521002A1; IT8319431A0; GB2153688A; JP2554844B2; FR2604896A1; DE3303803A1; AU1099583A; GB2114315B; IT8319431A1; JPH07144003A; GB8302853D0

Abstract

DEFORMABLE INTRAOCULAR LENS STRUCTURES AND
METHODS AND DEVICES FOR IMPLANTATION

ABSTRACT
An intraocular lens which is used as an arti-ficial lens implant in an eye has a deformable optical zone with known memory characteristics. These enable the lens to be deformed. Such as by compressing or rolling, to 80% or less of the cross sectional diameter of the optical zone in an unstressed state, but allow the lens to return to its original ocnfiguration and fixed focal length after implantation.
A surgical device is disclosed for deforming the lens, which device has a shaft having at one end a member engageable with a distal portion of the lens and another member engageable with a proximal portion of the lens. The two members are movable one relative to the other to effect deformation of the optical zone of the lens during insertion of the lens into the eye.

Description

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DEFORMABLE INT~AOCUI,AR LE~S STRUCTURES
AND METHODS AND DEVICES FOR IMPLANTATION

Back~round of the Invention 5 Intraocular lenses have gained wide accep-tance in replacemen-t of human crystalline lens after a variety of catarac-t removal procedures.
The human crystalline lens is generally recognized -to be a -transparent struc-ture having a thickness 10 of about 5 millimeters and diameter of about 9 millime-ters. The lens is suspended behind the iris by zonular fibers which connect the lens to -the ciliary body. A lens caps~le surrounds the lens, ~the front portion of -the capsule being commonly 15 known as the anterior capsule and the back portion commonly known as the posterior capsule.
Numerous procedures for the removal of cataracts have been developed in which the lens is removed from the eye and replaced by an arti- 20 ficial lens implant. The extraction procedure may be generally categorized as intracapsular (in which the lens is removed together wi-th the lens capsule) or extracapsular (in which the anterior capsule is removed with the lens, and 25 the posterior capsule is left intact).
Since Ridley implanted the first artificial lens in about 1949, the problems associated wi-th cataract extraction and lens implantation have received a great deal of attention from 30 ophthalmic surgeons.
Various types of artificial lenses have been proposed, and appropriate surgical procedures have been developed which strive to reduce patient ` ~ 35 discomfort and reduce post-operative complications. 35 Reference is made in this connection to Pseudophakos by N. Jaffe, et al; "History of Intraocular Implants"

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by D.P. Choyce (Annals of Ophthalmology, October 1973); U.S. Patent No. 3,991,426 issued to Flom on November 16, 1976; and U.S. Patent No. ~,092,7~3 issued to Kelman on November 8, 1977. 5 Of particular interest in the context of -the presen-t invention is the development of surgical technlques requiring relatively small incisions in the ocular tissue for the removal of cataracts as disclosed in U.S. Patent No. ~,002,169 10 and U.S. Patent No. 3,996,935. A number of skilled artisans have disclosed intraocular lens structures comprising an optical zone portion generally made of rigid materials such as glass or plastics suitable 15 for optical use. 15 However, one of the principle disadvantages of the conventional rigid intraocular lens is that implantation of the l~ns requires a relatively large incision in the ocular tissue~ This type 20 of surgical procedure leads to a relatively high 20 complication rate, among other disadvantages.
For instance, the serious dangers associated with implantation of a rigid lens structure include increased risks of infection, retinal detachment, 25 and laceration of the ocular tissues, particularly 25 with respect to the pupil.
Accordingly, those skilled in the art have recognized a significant need for an intraocular lens implant which affords the clinical advantages 30 of using relatively small incision techniques, yet 30 ; possesses an optical zone portion having a fixed focal length and which will retain a prescribed configuration once, implanted in the central ; optical area, thereby providing a safer and more 35 convenient surgical procedure and comfortable fit 35 for the eye. The present invention fulfills these needs.

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~Z7~51 SUMMARY OF THE INVENTI(~N
This lnvention provides a deformable intraocular lens structure for rep]acement of or refractive correction of a natural crystalline lens and being insertable through a small incision, relative to the incision required for rigid intraocular lens structures oE comparable size, made in the ocular tissue after cataract removal procedure, said intraocular lens structure having a total length within a range of 9 mm to 14 mm and a total width within a range of 4 mm to 14 mm, comprising in combination: a de-formable optical zone portion having, in an unstressed state, athickness within a range of 0.1 mm to 1.00 mm and a diameter of 4 mm to 6 mm, and having an elongation to break within a range of from 50 percent to 200 percent, said deformable optical zone portion having prescribed memory characteristics which enable the lens to be temporarily deformed by compressing, rolling, folding, or stretching said optical zone portion to a diameter of sub- -stantially 80% or less of the cross-sectional diameter of said optical zone portion in an unstressed state, yet return to its original configuration, full size and fixed focal length after implantation in the eye, and at least one integral or non-integral appendage for facilitating positioning of the lens within the eye attached to said optical zone portion which will not interfere with the deformability of the optical zone portion of the lens.
Disclosed methods for implantation of the artificial intraocular lens can be utilized for replacement of, or for re-fractive correction of, a human crystalline lens. These methods include:
providing an intraocular lens having a deformable optical zone .

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deforming the op~ical zone portion of ~he lens ~o a diameter of about 80% or less of the cross-sectional diameter of the optic in an unstressed state; inserting the intraocular lens through a relatively small incision made in the ocular tissue;
allowlng the lens implant to return to its original con~i~uration, ~ull size and fixed focal length after insertion in the eye;
whereby a safer, more convenient surgical procedure and more comfortable fit for the eye is achieved.
Objects and advantages will become apparent ~rom the following more detailed description of the invention, taken in conjunction with the drawlngs.
BRIEF DESCRIPTION OF THE DRAWINGS
Figure 1 is a stylized frontal view of a human eye illustrating a relatively small surgical incision made in the ocular tissue relative to 1~ .
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Figure 2 is a partially side sectional view of the human eye shown in Figure 1 illustrating 5 the internal condition of the ocular area after extracapsular cataract ex~raction in accordance with conventional procedure;
Figure 3 is a front elevational view of 1~ one embodied form of a deformable intraocular 10 lens in accordance with the present invention;
Figure 4 is a s.ide sectional view of -the intraocular lens shown in Figure 1 of a biconvex lens specie;
Figure 5 is a side sectional view of the 15 intraocular lens.shown in Figure 1 of a plano convex lens sp.ecie;
Figure 6 is a side sectional view of the intraocular lens shown in Figure 1 of a plano concave lens specie; 20 Figure 7 is a side sectional view of the intraocular lens shown in Figure 1 of a biconcave lens specie;
Figure 8 is a side sectional view of the intraocular lens shown in Figure 1 of a concave- 25 convex lens specie;
Figure 9 is a fron-t elevational view of a second embodied intraocular lens including means for facilitating su-tur;.ng, manipulation, or fluid flow; 30 Figure 10 is a side sectional view of the intraocular lens shown in Figure 9, indicating holes perforating the full thickness of the lens;
: Figure 11 is a front elevational view of a third embodied intraocular lens provided with 35 fixating appendages having optional compressible internal support elements;

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~7535 Figu:re 12 is a side sectional view of the in-traocular len~ shown in Figure 11 illustrating uniplanar fixating appendages;
Figure 13 is a front elevational view of fourth embodied intraocular lens including means 5 for facilitating suturing, manipulation, or fluid flow and comprising non-integral fixating appendages;
Figure 1~ is a side sectional view of the intraocular lens shown in Figure 13, this 10 èmbodiment, illustrating the fixating appendages as angula-ted;
Figure 15 is a front elevational view of a fifth embodied intraocular lens having angulated compressible fixating appendages with internal 15 supporting element;
Figure 16 is a side sectional view of the intraocular lens shown in Figure 15;
Figure 17 is a front elevational view of a sixth embodied intraocular lens having a 20 compressible peripheral support ring and illustrating a tinted or occluded periphery;
Figure 18 is a side view of -the intraocular lens shown in Figure 17;
Figure 19 is a front elevational view f 25 a seventh embodied intraocular lens, the optical zone portion of the lens being suspended by threads or spokes from a non-integral peripheral support ring;
Figure 20 is a side sectional view f 30 the intraocular lens depic-ted in Figure 19;
Figure 21 is a front view illustrating : the intraocular lens depicted in Figure 3 fixated to the iris of the eye in front of the pupil;
Figure 22 is a side sectional view of the 35 intraocular lens depicted in Figure 21;
Figure 21a is a front view illustrating the intraocular lens of Figure 3 fixated to the .
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iris of the e~e in back of the pupil;
Figure 22a is a side sectional view of the fixated intraocular lens depicted in Figure 21a;
Figure 23 is a front view of the intraocular lens shown in Figure 11 fixated in the anterior 5 chamber of the eye in front of the iris, -the lens having uniplanar, in-tegral support appendages to position the optic over the pupil;
Figure 24 is a side sectional view of the fixated lens as shown in Figure 23; 10 Figure 25 is a front view of the lens shown in Figure 15 fixated in a position in front of the iris and pupil;
Figure 26 is a side sectional view of the fixated lens as shown in Figure 25; 15 Figure 27 is a front view of the intra-ocular lens depicted in Figure 13 illustrating fixation of the lens behind the iris and pupil;
Figure 28 is a side view of the fixated lens shown in Figure 27 illustrating positioning 20 of support appendages in front of the ciliary body and the lens optic in front of the posterior capsule;
Figure 29 is a front view illustrating the lens depicted in Figure 19 fixated behind the iris and pupil; 25 Figure 30 is a side sectional view of the fixated lens shown in Figure 29 further illustrating the lens in position within the capsular bag;
Figure 31 is a partial sectional view of the eye during one embodied implant method~utilizing 30 ocular tissue surrounding a surgical incision to compress -the deformable intraocular lens to an appropriate diameter with the aid of a first embodied microhook type instrument;
Figure 32 is a side sectional view of the 35 : microhook type instrument utilized in the insertion technique shown in Figure 31;
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of the intraocular lens and fur-ther illustrates -the use of surgical connec-ting ~laterial removably a-ttached to -the periphery of -the lens to pull the 5 lens as it is deformed through the incision;
Figure 3~ i9 a side sectional view of a second embodied microhook type instrument which can be u-tilized in place of the surgical connecting ma-terial to assist pulling of the deformable 10 intraocular lens through the incision and into the desired position in the eye;
Fi~ure 35 is a side view of a third embodied microhook type instrument, including a double hook sys-tem designed to stretch the 15 deformable intraocular lens in a direction per-pendicular to the incision as an alternative procedure to the tissue stress technique shown in Figures 31 and 33;
Figure 36 is a front sectional view of 20 the eye illustrating a -third embodied implant procedure utilizing the double microhook -type instrument shown in Figure 35 to stretch the deformable intraocular lens during insertion of the lens into the desired posi-tion in the eye; 25 Figure 37 is a perspective view of a fourth embodied device of the injection type utilized to compress the deformable intraocular lens during insertion into the eye;
Figure 38 is an enlarged fragmentary view 30 of theforward portion of the insertion device shown in Figure 37 and further illustrating a transparent lens holding chamber of the device, the lens being in a natural unstressed state;
Figure 39 is an enlarged fragmentary 35 view of the forwardly mounted lens holding chamber of the device depicted in Figure 37 and :- . . . ~ , ': , ' ', ' .

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Figure ~0 is an enlarged ragmentary view of the tip of the lens holding chamber of 5 -the device of Figure 37 illustrating the deformable in-traocular lens returning to its original unstressed shape as it exits from the mouth of the extension cannula for implan-tation in the eye;
Figure L1 is a front sectional view of 10 an embodied implant procedure wherein the device of Figure 37 is fitted with a short nozzle at the forward portion of the lens holding chamber for releasing the lens just through -the incision 15 for anterior chamber or posterior chamber fixation; 15 Figure ~2 is a front sectional view of an imp].ant procedure utilizing the device shown in Figure 37, the lens holding chamber having an extension cannula utilized -to facilitate placement of the lens in the posterior chamber 20 through the pupil;
Figure 43 is a longitudinal perspective view of the nozzle portion of the lens holding chamber depicted in Figure 37 illustrating the lens in a rolled condition as i-t undergoes 25 deformation during the implant procedure;
Figure ~ is a longitudinal perspective view of the nozzle portion of the lens holding chamber depicted in Figure 37 illustrating the 30 ~ lens in a folded condition; 30 Figure /,5 is a longitudinal perspective view of the nozzle portion of the lens holding : chamber depicted in Figure 37 illustrating the lens in a partly rolled and partly folded condition;
: 35 Figure ~6 is a longitudinal perspective 35 view of the nozzle portion of the lens holding : chamber depicted in Figure 37 illustrating -the : `: :
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lens in a random 'crumple" fold condition;
Figure 47 is a perspective view of yet another embodied device of the injection type utilized for implantation of the inventive intraocular lens in accordance ~ith the present 5 invention illustrating a lens holding compartment mounted beyond the orifice of the device;
Figure 48 is an enlarged fragmentary view in section of the joinder between the lens holding compartment and orifice of the device 10 depicted in Figure 1~7 undergoing extraction of the lens from the compartment by means of suction exerted from -the cannula and loading the device for entry into the ocular incision;
Figure ~9 is an enlarged fragmentary 15 view of the joinder between the lens holding compartment and orifice of the device depic-ted in Figure ~7 and illustrates an alternate me-thod of loading the cannula of the device by means for pulling the lens from the compartment to the 20 orifice;
Figure 50 is a top view of yet another embodied implantation instrument of the forceps type utilized to deform the intraocular lens during insertion through the ocular incision; 25 Figure 51 is a fragmentary view of the instrument depicted in Figure 50 having modified ends to deform the lens w.ith a minimum amount of pressure exerted by the instrument on the lens in the maximum cross-sectional volume present in 30 the ocular incision;
Figure 52 is a schematic cross-sectional view of the instrument depicted in Figure 50 illustrating the device in a partially closed state with ~e in-traocular lens being part].y deformed; 35 two rigid plates are shown to hold the lens in the plane of the forceps to facilitate enclosure;

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~igure 53 is a longitudinal cross-sectional view of the inventlve forceps type instrumen-t fully deforming an intraocular lens therein;
Figure 54 is a longitudinal sectional view 5 of the forward end of the inventive forceps type device having a hinged compressing mechanism and a rigid bowl-shaped accessory to facilitate lens encasement and release performance of the device within the eye; 10Figure 55 is a cross-sectional view of the device illus-trated in Figure 54, the intraocular lens being completely encased within the hinged ~ compressing mechanism;
: 15 Figure 56 is a front sectional view of 15 an implant procedure utilizing the forceps type device shown in Figure 50 to place the intraocular lens in a posterior chamber through a relatively small incision and iridectomy;
Figure 57 is a front sectional view of 20 an implant procedure utilizing a "cut away"
forceps type device to place the intraocular lens in a pos-terior chamber through the pupil;
Figure 58 is an enlarged fragmentary 25 sectional view of the forward end of a forceps type~ 25 device including a modification designed to use hydraulic pressure to eject the lens out of the forcep ends and into the eye similar to the procedure shown in Figures 39 and 40 above;
Figure 59 is a top view of -the device ~ depicted in Figure 58;
: Figure 60 is a side sectional view of an eye with natural crystalline lens intact and an : intraocular lens of the corrective type as shown : 35 in Figure 20 in position in the posterior chamber between the iris and human crystalline lens;

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- . : , ~igure 61 is a cross-sectional view of an eye with human crystalline lens intact and an intraocular lens in position in -the anterior chamber of the eye for corrective purposes.
DESCRIPTION OF T~E PRE~ERRED EMBODIMENTS 5 The present inven-tion provides deformable intraocular lens struc-tures having prescribed memory characteristics and methods and instru-mentation for implantation of such lens for 10 correction of or replacement of a human crystalline 10 lens. ~ unique optical zone portion of the intraocular lens possesses memory characteristics such that -the lens can be deformed by compressing, rolling, folding or stre-tching the optical zone 1S portion -to a diameter of 80% or less than the 15 cross-sectional diameter of the optic during insertion into the eye yet return to its original configuration, size and fixed focal length once implanted in the eye, thereby providing a safer, more convenient, and more comfortable surgical 20 procedure.
Referring now to the drawing~ denoted Figure 1, there is shown a stylized frontal view of an eye illustrating the major ocular components:

2~ iris 11, pupil 12, limbus 13, sclera 14 relative 25 to a small incision 15 made in the ocular tissue, for instance, implantation of an intraocular lens in accordance withthe present invention.
Figure 2 represents a side cross-sectional 30 view of the eye shown in Figure 1 and illustrates 30 major ocular components in more detail. The cornea 16 is composed of clear tissue which connects to the sclera 14 at the limbus 13. The anterior segment of the eye is divided into two principle chambers by the iris 11 and pupil 12. 35 An anterior chamber 17 is defined by the space between the cornea 16 and the iris 11. h posterior chamber 18 is defined by the space ;':

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betw~en the iris 11 and the vitreous 19.
In surgical procedures commonly known as lntracapsular cataract extraction, the posterior chamber 18 is bounded by the hyloid membrane 20.
In surgical procedures commonly known as the 5 extracapsular cataract extraction, the posterior chamber 18 is bounded by the posterior capsule 21 attached to the ciliary body 22 by means of zonular fibers 23, Portions of the anterior capsule may remain as flaps 2~, creating, with 10 the posterior capsule, 21 the ocular portion commonly known as the "capsular bag". The posterior chamber 18 peripheral area between the iris 11 and the extension of the ciliary body 22 is referred to as -the ciliary sulcus 26. The 15 anterior chamber peripheral area between the cornea 16 and the iris 11 is referred to as the angle 27 of the eye. The area of the sclera posterior -td the plane of the iris and anterior to the vitreous 19 is known as pars plana 28. 20 With the foregoing referenced ocular components in mind, it is a principle feature of the present invention to provide a class of intraocular lens structures having a deformable optical zone portion such that the lens with 25 optional fixation appendages can be deformed by compressing, rolling, folding or stretching to a diameter of 80% or less of the cross-sectional diameter of the optic during insertion into the eye, yet return to its original full size and 30 fixed focal leng-th once implan-ted in thé eye.
Accordinglyt the inventive intraocular lens structures can be implanted through smaller incisions made in the ocular tissue than would be possible with any rigid intraocular lens of 35 comparable size.

.., i Figure 3 depicts an intraocular lens 30 in accor-dance with the present invention which is suitable for use as an artificial lens implant. In the embodied form shown7 there are no fixation appendages and the lens comprises a deformable 5 optical zone portion 3~ imparted with desirable memory characteristics, appropriate structural dimensions, and composed of a deforrnable material such tha-t the lens can be deformed to an appropriate size for insertion into the eye.10 Typically, -the optical zone portion 31 of the lens 30 is composed of one or more suitable materials such as polyurethane elastomer J silicone elastomer, hydrogel polymer collagen compounds, organic or synthetic gel compounds and combina- 15 tions thereof. In one embodied form, the optical zone portion 31 of the lens can be fabricated having a base member composed of any of the fore-going materials, and further comprise a surface layer or layers of a second or third material. 20 Moreover, the lens may be tinted, colored or -fabricated with occluded portions to yield desired transmission effects.
As shown in Figures 4, 5, 6, 7, and 8, 2S the inventive lens can be fabricated having a 2S
wide variety of crOSS-seGtions designed for replacement of the surgically removed human crystalline lens or for refractive correction without removal of the human crystalline lens.
In this respect, the Figures 4 - 8 illustrate30 respectively a convex lens 32, a plano convex lens 33, a plano concave lens 34, a biconcave lens 3S, and a concave-convex lens 36.
Referring to Figure 9, there is illustrated another embodied in-traocular lens structure 37 in accordance with the present invention, the lens being provided with means 38 for assisting ., :

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- ~5 suturing, manipula-tion, or ~luid flow through the lens. In this respect, the lens may optionally be provided with one or more holes 38, suitably located, which ma~ extend entirely through the cross-section of the lens as shown in Figure 10, 5 or partially through -the cross-section of the lens as an inden-tatlon for facilitating maneuvering of the lens during surgical procedures.
Further, in accordance with the present invention, the inven-tive intraocular lens struc- 10 tures may comprise integral or nonintegral appen-dages -to facilitate positioning of the lens within the eye. Figures 11 - 20 illustrate a wide variety of appendages which may be utilized.
In more detail, Figure 11 depicts an15 intraocular lens 30 optionally provided with appendages 39 of the compressible-integral suppor-t element type. As seen in Figure 12, the appendages 39 in this embodiment are uniplanar with the optical zone portion 31 of the lens. 20 Figures 13 and 14 depict the inventive intraocular lens provided with a plurali-ty of holes 40 therethrough and angulated support appendages 41 with respeGt to the plane of the optic. Such appendages may be composed 25 of any suitahle material and may be selected from a material different from that of the optical zone portion of the lens.
Figures 15 and 16 illustrate an inventive intraocular lens 42 provided with angulated30 compressible appendages 43 with internal supporting elements, That is, the supporting structure is internally contained within the appendages as shown.
Figures 17 and 18 depict an inventive 35 ; intraocular lens 44 having a deformable peripheral ~: :
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support ring ~5 and a tinted or occluded periphery ~6 which is a substantially continuous peripheral flange.
~igures 19 and 20 illustrate yet another intraocular lens structure ~7 in accordance with 5 the present invention wherein the optical ~one por-tion ~8 is suspended oy threads or spokes 49 from a peripheral supporting ring 50 constructed of a suitable material.
As will readily be appreciated by those 10 skilled in the art, the foregoing specific embodiments are merely illustrative of the wide variety of intraocular lens structures included within the spiri-t and scope of this invention.
In this respect, it shoul.d be understood that the 15 :` provision of appendages and.means for facili-tating ~ manipulation, fixation or fluid flow through -the lens are optional. The latter means includes holes, openings, depressions and/or passageways to aid the surgical procedure. 20 .Figures 21 and 22 illustrate implan-tation of the intraocular lens 30 fixated to the iris 11 of the eye in front of the pupil 12. In the depicted embodiment, a piercing suture 51, such as one fabricated from stainless s-teel, is disposed at 25 an appropriate location along the lens periphery and inserted through the iris 11 in a surgical procedure which replaces the human crystalline lens previously extracted from the eye. While the foregoing figures illustrate fixation of the 30 lens 30 shown in Figure 3, it should be readily understood that each of the foregoing embodied lens structures could be also fixated in a similar ~ manner.
: 3S ~igures 21a and 22a illustrate an alterna- 35 ~-tive positioning of the intraocular lens 30 in accordance withthe present invention, behind the .

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iris 11 of the eye, behind the pupll 12, In the illustrated embodimen-t, -the lens 30 is also sutured in place by means of a piercing suture 51 such as one composed of stalnless steel.
Figures 23 and 24 depict a typical posi- S
tioning of the intraocular lens 30 shown in Figures 11 and 12 in the anterior chamber of the eye in front of the iris 11, with supporting appendages 39, to fixate the optic over the pupil 12. In these illustrations the lens is shown 10 without the optional internal supporting elements.
Figures 25 and 26 illustrate positioning of the intraocular lens 42 shown in Figures 15 and 16 in a position in f:ront of the iris 11 and the pupil 12 wi-th supporting appendages 43 15 angulated with respect to -th.e plane of the optic.
Figures 27 and 28 illustrate placement of the intraocular lens shown in Figures 13 and 14 in a position behind the iris 11 and pupil 12.
The supporting appendages 41 are positioned in 20 front of the ciliary ~ody 22 and the optical zone por-tion of the lens is positioned in front of the pos-terior capsule 21.
Figures 29 and 30 depict the intraocular lens 47 shown in Figures 19 and 20 after implan- 25 tation, and positioned behind the iris 11 and the pupil 12 within the capsular bag.
Accordingly, those skilled in the art will readily appreciate that the deformable intra-: ~ 30 ocular lens implant provided by the present 30 invention can be fixated in the eye in a wide variety of locations and that a wide variety of supporting appendages may optionally be included with the deformable optical zone 3S portion of the lens to fixate the lens in the 35 desired position.
One important. feature of the lens in ~: :

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accordance with the presen-t invention is that it lends itself to positions which allow the free mobility of the pupil, that is, in terms of normal pupillary functions when in place in the eye.
The presen-t invention further provides 5 unique methods and devices for implantation of the intraocular lens by temporarily deforming the op-tical zone portion to a diame-ter of 80% or less of the cross sectional diameter of the optical zone portion in an unstressed state. After 10 insertion into theeye, the optical zone portion returns to its prescribed original optical configura-tion, full size, and fixed focal length, -thereby providing a safer, more convenient surgical procedure and more comfortable fit for the eye. 15 Referring now to Figures 31 and 32, there is illustrated a first embodied method comprising deforming the unique intraocular lens 30 by pushing a dis-tal portion 30, of the ]ens 30 -through a relatively small incision 15 made in 20 the ocular tissue. A specially designed implan-tation instrument which may generally be described as a single microhook device comprising a very thin, rela-tively rigid shaft 51 having an engage~
ment bend 52 in the forward portion thereof to 25 engage the distal rim or hole of the intraocular lens 30 may be utilized to effect insertion of the lens through the incision 15. In this respect, the engagement bend 52 may be configured in a variety of ways, for instance, straight or 30 outwardly curved bend, to facilitate engagement of thedistal rim or hole in the intraocular lens 30.
Accordingly, the microhook device ; engaged with the lens 30 is initially inserted through the incision 15 and -the lens 30 undergoes 35 deforma-tion to an appropriate diameter by ~ compression of -the lens caused by the pressure .~

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exerted b~ the surrounding tlssue around the incision 15. The lens 30 is thereafter fully inser-ted into the eye in a desired position. Op-tionally, the microhook implantation instrument can be provided with an addi-tional tine to prevent the rim of the lens from sliding over the needle, dele-teriously releasing tension on the lens.
A second embodied method is depicted in Figure 33, the method also features the use of the surgical incision 15 -to deform the intraocular 10 lens 30. In this embodied form, the lens 30 is pulled through the surgical incision 15 by use of a connecting material 53, such as suture thread or the like. The connecting material 53 has been inserted through a second mîcroincision 15, on 15 the opposite portion of the eye, and passed -through a hole 5~ provided in the periphery of the lens 30 and returned through the original incision 15. Accordingly, the two ends of the connecting material 53 are grasped and withdrawn 20 which allows the lens 30 to be pulled into proper position into the eye. Once positioned inside the eye, one end of the connecting material 53 is released and the entire connecting material 53 is withdrawn, leaving the lens 30 in 25 position. As shown in Figure 3~, a microhook type device 55 can be used in place of the connecting material 53 to pull the lens 30 into the eye from a second micro incision 15, made therein. 30 Referring now to Figures 35 and 36, there is illustrated yet another embodied method for implantation of the lens 30 in the eye. In this ~; embodied form, a double microhook type device 56 35~ ~ shown in Figure 35 is utilized to stretch -the 35 intraocular lens 30 in a direction perpendicular to the incision 15, thereby deforming the lens 30 :~ :
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in the plane of the lncision 15 sufficiently to allow insert,ion of the lens 30 through a relatively small incision 15, without ocular tissue stress as featured in the foregoing embodiments.
I'he double microhook device 56, as shown S
in Figure 35, comprises parallel positioning of two needles 57 and 58, either co-axial or side-by-side, which facilitates one-handed operation by the surgeon. It should be understood however, that the same deformation can be 10 accomplished in a bimanual opera-tion with, for instance, the two microhook devices 50 and S5, shown in Figures 32 and 34.
In more detail, the device S6 depicted in Figure 35 comprises a first needle 57 slideably 15 mounted in associa-tion with a second needle 58 in such a manner as to be used as a means for retaining the lens 30 by engaging the proximal portion of the lens 30 to stabilize the lens 30 while the second needle 58 engages a dis-tal 20 portion of the lens 30. The force necessary to deform the lens 30 is applied by means of the plunger 59 so as to move the two hooks 57 and 58 away from each other, thereby stretching the engaged lens 30. 25 Referring now to Figures 37 through 46, there is illustrated yet another embodied method and inventive device 60 for implantation of the deformable intraocular lens 30 in accordance with the present invention. 30 More particularly, Figure 37 depicts an implantation device 60 utilizing mechanical/
hydraulic deforming force. The device 60 cornprises a chamber 61 with an inlet opening 62 and a small outlet opening 63 designed for placement in or 35 adjacent to a small incision 15. In this respect, the deforming force, either mechanical, hydraulic : ~
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i27~ 51 or pneumatlc force, is applied through the inlet openin~ 62 of -the device 60 in such a manner that the lens 30 i3 forced into and through the small outle-t 63 and in-to the eye through the cannula 64 at the distal end of the device. 5 The intraocular lens 30 is initially positioned in the chamber 61 between the source of pressure, for instance, a manual syringe 65 as depicted, or other suitable system, and the orifice 66 through which it will pass before 10 entering the eye. Optionally, the lens holding chamber 61 may be fabricated from a sterile transparent material so that the lens 30 may be inspected without opening -the chamber 61 to avoid 15 exposure of the contents to undesirable contamina- 15 tion. The device as shown in Figure 41~ may comprise a rela-tively short nozzle 67 to facilita-te anterior or posterior chamber lens placement~
Alternatively, -the device may be fitted with a 20 relatively long nozzle 68 to facilitate placement 20 of the lens 30 through the pupil 12 into the posterior chamber 18.
Figure 38 most clearly illus-trates the lens holding chamber 61 of the device 60 shown in Figure 37. The lens holding chamber 61 is 25 preferably composed of transparent material and appropriately designed to contain the lens 30 in a natural, unstressed state. Preferably, the lens 30 before insertion and within the chamber 61 J
is suspended in a suitable liquid medium such as 30 distilled water~ saline or a biocompatible lubricating fluid such as hyaluronic acid or condroitin sulfate. As shown in Figure 38, the chamber 61 in one embodied form is adapted to hold a lens 30 without supporting appendages and 35 having a circular optical zone portion 31.
However~ it should be understood that such chamber .

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can be adapted in a varie-ty of configurations to - facilita-te placement of various intraocular lens structures in accordance with the present invention.
Figure 39 depicts the lens 30 undergoing deformation by the action of fluid pressure as 5 it is applied from the rear of the chamber 61 forcing the lens 30 into the narrow cannula 64 and ou-tlet opening 63 which has been preplaced through the incision 15 made in the ocular tissue.
As shown in Figure ¢0, the lens 30 10 returns to its natural, unstressed state as it exits from ~he relatively long nozzle 68 in the eye. In accordance with -the present invention, the memory characteristics of the inventive lens are imparted by appropriate selection of lens 15 material, and the combination of lens dimensions and fabrication techni~ues which imparts the desired lens configuration. The deformable op-tical zone portion of the lens must have an elongation 20 to break of at leas-t about 50 percent and preferably 20 in the range of from about 50 percent to about 200 percent or higher.
Figure 41 further illustrates posi-tioning of the lens holding chamber 61 of the device 60 shown in Figure 37 equipped with a short nozzle 67 25 for releasing the lens 30 just through the incision 15, as an anterior chamber or posterior chamber (through iridectomy or pars plana) placement.
Figure 42 illustrates an alternative embodiment in which an extension cannula creating 30 a long nozzle 68 is utilized to facilitate place-men-t of the lens 30 in the posterior chamber 18 through the pupil 12.
Figures ~3 through 46 are cross-sectional 35 views of ~the lens 30 while deformed in the cannula 35 6~ of the devic-e 60. In this regard, Figure 43 illustrates the lens 30 deformedin arolled :
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and Figure 46 i]lustrates a deformed lens 30 in 5 a random "crumple" folded condition as might be anticipated in the implantation techniques shown in Figures 31 and 33.
Figure l~7 depicts yet another embodied implantation device 70 in accordance with the 10 presen-t invention of the "injection type". In this embodied form, the in-traocular lens 30 is packaged in a lens holding compartment 71 as generally shown in Figure 38, but the compartmen-t 71 is adapted for mounting beyond the orifice 66 15 of the device 70~ Accordingly, in this procedure, the deformable lens 30 is first removed from ~the compartment 71 and loaded into the cannula 72 of the device 70 shown in Figure 47. The compartment 71 is thereafter detached, and the 20 cannula 72 is inser-ted into the incision for placement of ~the lens 30 in the eye. The lens holding compartment 71, is therefore provided with a small outlet 73 designed for snug engage-ment with the nozzle 74 of the device 70 for 25 placement in or adjacent to a small incision in the ocular tissue. The deformable lens is held in a substantially unstressed state un-til force, ~or instance, mechanical or suction, is applied through the outlet 73 in such a manner as to 30 engage the lens 30 and draw it through the outlet 73 and into the engaged nozzle 74 from which i-t will be injected into the eye.
~ In more de-tail, Figure 48 illustrates one method of removing the lens 30 from the lens 35 holding compartment 71 utilizing suction from the cannula 72 and with or without corresponding . ~ . . .
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posi-tive pressure from the o-ther side.
Figure ~9 shows an al-ternate method of loading the cannula 72 by utilizing a microhook or connecting ma-terial 53 to pull the lens in-to S place in a manner similar to that shown in 5 Figure 3~.
The device shown in Figure ~7 may comprise a valve, hole, or other inlet to facilitate the removal of the lens from the compartment 71 -to the nozzle 74. 10 Figure 50 depicts yet another implan-tation instrumen-t 75 designed -to simul-taneously grasp and compress the deformable in-traocular lens 30 -to allow inser-tion of the lens 30 directly or indirectly into the eye. The embodied device 75 15 is of the forceps type and comprises a forward end 76 to encase -the lens therein when closed.
The forceps type device 75, may be modified as shown in Figure 51 in which the ends 76, of the device are shortened and hollowed to compress the 20 lens wi-th a minimal amount of instrument ma-terial in the maximum cross-sectional volume present in the incision. Of course, other modifications to the aevice can be made such as the provision of holes, cut-outs and the like, to facilitate lens 25 handling.
As shown in Figure 52, the device 75 will partly deform the intraocular lens when the forceps are in a partially closed state. Two plates or sheets 77 and 78 over and under -the 30 lens may be included to facilitate encasing the lens 30 entirely within the ends 76.
Figure 53 thus illustrates the forceps type device 75 with a lens completely encased therein. 35 Figure 5~ illustrates an alterna-te arrangement of the forceps ends 76" so that the :: .
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ends 76" con-tact or hinge first a-t the top and then close at the bottom. A bowl-shaped compressing mechanism may optionally facili-tate lens encasement for this embodied form which enhances ler~s release performance within the eye. 5 Figure 55 illus-trates in more detail the embodied device 75" of Figure 54. In Figure 55, the lens 30 is completely encased within the ends 76" of the device.
~igure 56 further illustrates the surgical 10 procedure for implanta-tion of the lens 30 in the posterior chamber 18 through a relatively small incision 15 and iridectomy utilizing one embodied form of -the forceps type device.
Figure 57 depicts the use of a forceps 15 type device 75 of the cut-away varie-ty to place the lens 30 in the pos-terior chamber 18 through the pupil 12. It should be understood however, that -these devices can readily position the lens 30 in the anterior chamber 17 as well. 20 Figures 58 and 59 depict yet another embo-aiment of the forceps type device. In this embodied form, the device 79 includes the use of hydraulic pressure to be applied for ejection of the lens 30 from -the ends 76 and into the eye. 25 In this respect, mechanical, hydraulic or ;-pneumatic pressure may be exerted by a tube or pipe 80 mounted on an adjacent portion of the device 79.
As previously mentioned, the present30 invention is readily adapted to implant lens for refractive correction of the human crystalline lens without removal thereof. As shown in Figures 60 and 61, -the intraocular lens 47 is 3S placed in the posterior chamber 18 between the 35 iris 11 and -the human crystalline lens as shown in Figure 60. The lens 47 illus-trated is of the type shown in Figures 19 and 20 herein.

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~igure 61 shows an alternate positioning of -the lens ~7 shown in Figures 19 and 20 posi-tioned in the anterior chamber 17 of the eye with the natural crystalline lens still intact and in place. 5 Typically, the inventive intraocular lens structure will have a -total length of from about 9 millimeters to about 14 millimeters, a width of from about 4 millimeters to about 1~ millimeters and can be fabricated having a wide range of 10 index of refraction. The deformable op-tical zone por-tion will typically have a thickness of from about .1 millimeters to about 1.0 millimeters and a diameter in the range of from about 4 millimeters to about 6 millimeters. 15 Any conventional method for manufacture of the inventive lens can be utilized in accordance - with the presen-t invention to insure that the lens has an elongation to break within the prescribed range as aforementioned herein. For instance, 20 compression molding, transfer molding, injection molding, casting, machinlng, or combination of these techniques may be utilized to produce the inventive lens.
The deformable intraocular lens structures 25 in accoraance with the present invention also - facilitate removal of the lens from the eye atraumatically should a complication arise after implant9 necessitating its removal from the eye.
Those skilled in the art will readily 30 appreciate that o-ther less preferred procedures could be utilized to effect deformation of the lens during implantation. For instance, a lens fabricated from hydrophilic material could be implanted in a dry state and hydrated once in 35 position to return to its desired configuration and fixed focal length. Alternatively, the lens : :-- -: ~ ~

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could be implanted in a plurality o~ separate components which are bullt up in the eye and suitably attached to one another, for instance by a medical grade adhesive.
The lens holdin~ chamber and lens holding compartment of the implantatlon devices depicted in Figures 37 through 49 can, of course, be fabricated having a wide variety of s~litable configuration~ for containing the de~ormable intraocular lens thereln. In thls respect, the chamber and compartment having pre-deformed lenses contained therein can be conveniently dlspensed separately ~rom the in~ection type devices.
Additionally, the intraocular lens structure i~
accordance wlth the present invention may comprise a baæe member having at least one surface layer thereon. For instancq, a base member composed o~ an elastomer can be encased wlthin a surface layer o~ hydrophilic material to enhance tissue compatibility.
The described lens implant procedures and devices, thus minimize the principle disadvantages attendant wi~h conventional rigid intraocular lens implantation which requires a relatively large incision in the ocular tissue which, among other di.sadvantages, leads to a relatively high complication rate and longer recovery times.

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It will be apparent from -the foregoing that, while particular forms o~ the invention have been illustrated and described, various modifications can be made without departing from the spirit and scope of the invention. Accordingly, 5 it is not intended that the invention be limited, except as by the appended claims.

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Claims

1. A deformable intraocular lens structure for replacement of or refractive correction of a natural crystalline lens and being insertable through a small incision, relative to the incision required for rigid intraocular lens structures of comparable size, made in the ocular tissue after cataract removal procedure, said intraocular lens structure having a total length within a range of 9 mm to 14 mm and a total width within a range of 4 mm to 14 mm, comprising in combination: a deformable optical zone portion having, in an unstressed state, a thickness within a range of 0.1 mm to 1.00 mm and a diameter of 4 mm to 6 mm, and having an elongation to break within a range of from 50 percent to 200 percent, said deformable optical zone portion having prescribed memory characteristics which enable the lens to be temporarily deformed by compressing, rolling, folding, or stretching said optical zone portion to a diameter of substantially 805 or less of the cross-sectional diameter of said optical zone portion in an unstressed state, yet return to its original configuration, full size and fixed focal length after implantation in the eye, and at least one integral or non-integral appendage for facilitating positioning of the lens within the eye attached to said optical zone portion which will not interfere with the deformability of the optical zone portion of the lens.

2. An intraocular lens as claimed in claim 1, wherein said at least one appendage is a uniplanar appendage.

3. An intraocular lens as claimed in claim 1, wherein said at least one appendage is an angulated appendage.

4. An intraocular lens as claimed in claim 1, wherein said appendage comprises an internal support element.

5. An intraocular lens as claimed in claim 4, wherein the internal support element is compressible.

6. An intraocular lens as claimed in claim 1, further comprising means for facilitating fluid flow through the lens in the eye.

7. The intraocular lens as defined in claim 6, wherein said means for facilitating fluid flow is at least one passageway disposed through said lens.

8. The intraocular lens as defined in claim 6, wherein said means for facilitating fluid flow is at least one depression disposed in said lens.

9. The intraocular lens as defined in claim 1, wherein said optical zone portion is colored or tinted.

10. The intraocular lens as defined in claim 1, wherein said optical zone portion includes occluded portions.

11. The intraocular lens as defined in claim 1, wherein said optical zone portion comprises an elastomeric base member encased within a hydrophilic surface layer.

12. The intraocular lens as defined in claim 1, including means for supporting said lens within the eye comprising a first material which is different from a second material used for fabricating said optical zone portion.

13. The intraocular lens as defined in claim 1, including means for supporting said lens within the eye comprising a substantially continuous peripheral flange integral with said optical zone portion.

14. The intraocular lens as defined in claim 1, including means for supporting said lens within the eye comprising a sub-stantially continuous peripheral flange non-integral with said optical zone portion.

15. The intraocular lens as defined in claim 1, wherein said optical zone portion is closed of a compound selected from the group consisting of silicone elastomers, polyurethane elastomers, hydrogel polymers, collagen compounds, organic gel compounds and synthetic gel compounds.

16. The intraocular lens as defined in claim 1, wherein said optical zone portion is suspended from a peripheral support ring.

17. The intraocular lens as defined in claim 16, wherein said suspension is effected by a plurality of threads connecting said optical zone portion to said peripheral support ring.

18. The intraocular lens as defined in claim 1 wherein said optical zone portion has either a biconvex, plano convex, plano concave, biconcave or concave-convex configuration.