Method of replacing an eye lens

A method of replacing a human or animal lens is disclosed, along with a tool for use in such procedure and a flexible lens for use as an implant or transplant. The procedure includes the use of a horizontal capsulotomy incision to allow for the removal of the lens from the lens capsule without destruction or removal of any portion of the capsule. No sutures or other unnatural materials are required. A special tool for use in this procedure is disclosed which includes saucer-shaped gripping members which can grip and loosen the lens from the lens capsule and keep the capsule open during the transplant. The implanted lens, which may be of a soft material having a variable focus, is formed from an inert, non-toxic material. When a natural lens or a flexible artificial lens is utilized in the procedure, the natural constriction and relaxation of the ciliary muscles allows for the variation of the focus of the lens in a manner which closely approximates that of the original natural lens.

FIELD OF THE INVENTION 
The present invention relates to intraocular lenses and more particularly 
to a new system for surgically removing a damaged lens and replacing it 
with a new lens. The present invention also relates to a new tool for use 
in such procedure as well as a new variable focus lens which can be 
implanted in an eye. 
BACKGROUND OF THE INVENTION 
There has long been a need for a satisfactory method of replacing the lens 
of a human or animal eye which has been damaged, through cataracts or 
other disease or accident. There have been numerous attempts to develop a 
procedure which is relatively safe and simple, which minimizes trauma to 
the eye, and which results in materially improved vision under a variety 
of conditions. 
For example, U.S. Pat. No. 4,253,199 to Anton Banko discloses various 
methods and apparatus for eye implants within the posterior chamber of the 
eye. In the procedure taught by Banko, the entire anterior portion of the 
lens capsule is apparently removed and, in some cases, the posterior 
portion of the lens capsule was also removed. An implant of the capsule is 
attached to the ciliary body by means of sutures. In the Banko procedure, 
there is considerable trauma to the eye, in that essentially the entire 
lens capsule is destroyed and removed. 
Another prior approach is illustrated in U.S. Pat. Nos. 4,254,509 and 
4,261,065 to Jerald L. Tennant. These patents disclose a lens implant 
which is positioned in the anterior chamber of the eye and not within the 
location previously occupied by the natural lens. In both of these 
patents, it appears that the natural lens as well as the entire lens 
capsule have been totally removed. 
U.S. Pat. No. 4,242,762, also in the name of Jerald L. Tennant discloses an 
implant within the lens capsule, whereby a triangular opening is formed in 
the anterior capsule. Similarly, in U.S. Pat. No. 4,243,510, also in the 
name of Jerald L. Tennant, the jagged margins represent an opening made in 
the lens capsule for fragmentation and removal of the lens. In both of 
these patents, at least part of the anterior portion of the lens capsule 
is destroyed in the process of replacing the lens. 
U.S. Pat. No. 4,251,887 in the name of Aziz Y. Anis discloses an 
intracapsular implant in which a triangular capsulectomy (that is, a 
removal of a portion of the capsule) is performed and there is inserted 
within the eye a lens with two side loops, each of which forms the shape 
of a kidney. Here again, a portion of the capsule is irrevocably removed 
and destroyed and, additionally, foreign substances are placed in the eye. 
In U.S. Pat. No. 4,002,169, there is disclosed a surgical method whereby a 
tool is inserted into the lens and probes are used to "masticate" the 
contents of the lens capsule. Suction is then used to withdraw the 
contents of the capsule. The interior of the capsule is then flushed and 
cleaned and a lens filler such a silicone is then inserted through the 
tool. All of this is accomplished through a thin needle. This procedure, 
while retaining the lens capsule, does not lend itself to the insertion of 
a new lens having a predetermined shape and most certainly could not be 
used to insert a live lens transplant. 
Russian Inventor's Certificate No. 572,267 to Alekseev appears to disclose 
a method of implanting an artificial crystalline lens. It appears that, 
through an unspecified special device, a capsulectomy (that is, removal of 
a portion of a capsule) is performed in the anterior area. The nucleus and 
crystalline masses are removed through a "round orifice" in the anterior 
capsule, and an intraocular lens of up to five millimeters in diameter is 
implanted into the crystalline bursa. Since a natural lens is 
substantially larger, it appears that Alekseev only removes the central 
five millimeters of the lens and replaces it with an implant. This 
essentially only replaces that portion of the lens which is aligned with 
the pupil. This procedure, like the others, poses certain disadvantages, 
including the fact that if a lens is diseased, removal of only a portion 
of the lens could result in continued problems after the surgical 
procedure. 
Accordingly, it is an object of the present invention to provide a new 
technique for a lens implant. 
It is a further object of the present invention to provide such a lens 
implant which minimizes trauma to the eye. 
It is another object of the present invention to provide such a lens 
implant which leaves the lens capsule substantially intact. 
It is an additional object of the present invention to provide such a lens 
implant which replaces a diseased lens with a lens having substantially 
identical optical characteristics. 
It is still another object of the present invention to provide such a lens 
implant which responds to the natural muscular movement of the eye to vary 
the focus of the lens under different conditions. 
It is still a further object of the present invention to provide a lens 
implant in which the entire diseased lens is removed and replaced. 
It is an additional object of the present invention to provide such a lens 
implant in which the newly implanted lens is positioned in substantially 
the same position as the lens which has been removed. 
It is yet a further object of the present invention to provide such a lens 
implant procedure which can be used for implanting lenses of varying 
types, sizes and shapes, including human and animal lenses. 
It is yet another object of the present invention to provide a lens implant 
procedure which avoids the use of sutures and which minimizes the number 
and types of foreign substances implanted within the eye. 
It is still a further object of the present invention to provide a variable 
focus lens for use with the aforesaid procedure. 
It is still an additional object of the present invention to provide an 
instrument for use with such a procedure which facilitates the removal of 
the diseased lens and the insertion of the new lens. 
Various other objects and advantages of the present invention will become 
clear from the following detailed description of several exemplary 
embodiments thereof, and the novel features will be particularly pointed 
out in conjunction with the claims appended hereto. 
SUMMARY OF THE INVENTION 
In accordance with the teachings of the present invention, a method of 
replacing a lens has, as a first step, the displacement of the cornea and 
conjunctiva to provide access to the iris. The iris is then positioned to 
provide access to the anterior lens capsule. A generally horizontal 
capsulotomy incision is performed in the anterior lens capsule. The 
superior portion of the capsular incision is folded back to expose the 
apex of the lens. A first portion of a removal tool is inserted between 
the anterior lens capsule and the anterior surface of the lens while 
inserting a second portion of the removal tool between the posterior lens 
capsule and the posterior surface of the lens. The lens is then grasped 
with the first and second portions of the removal tool and rotated to 
dislodge it from the capsule and partially remove it from the capsule. The 
lens is then removed while the capsule is kept open. A replacement lens is 
then inserted into the capsule, the tool is withdrawn from the capsule, 
and the superior capsule flap, the iris the cornea and the conjunctiva are 
all repositioned. 
The novel tool for use in accordance with the foregoing method includes a 
tweezer body having a normally open position and first and second ends. 
Gripping means are mounted to the first and second ends, which gripping 
means are substantially circular and have concave inner surfaces facing 
each other and convex outer surfaces. The concave inner surfaces are 
constructed and arranged to grasp a lens. 
The novel implant lens of the present invention is formed from inert, 
non-toxic materials and is sufficiently flexible so that its focus may be 
varied by constriction and relaxation of ciliary muscles.

DESCRIPTION OF THE PREFERRED EMBODIMENT 
Referring now to the drawings wherein like reference numerals designate 
like parts throughout the several views, FIGS. 1-4 represent, in that 
order, several of the stages of the surgical procedure of the present 
invention. The patient's eye is represented generally by reference numeral 
10. 
The procedure begins with a 10 o'clock to 2 o'clock superior corneal 
incision and conjunctival flap which allows for the cornea 12 and the 
conjunctiva 14 to be displaced from the area directly in front of the lens 
and to provide access to the iris 16. At this time, it is necessary to 
position the iris 16 to provide access to the anterior lens capsule 18. 
This can be accomplished with a 12 o'clock complete iridectomy. 
Alternatively, the iris may be dilated if complete dilation can be 
accomplished. The iris 16 is then moved aside by means of a suture or an 
iris forceps. 
The next step in the procedure is the performance of a generally horizontal 
capsulotomy incision in the anterior lens capsule 18. The capsulotomy is 
located approximately three millimeters below the apex of the anterior 
capsule 18 and extends from left to right from about the 10 o'clock 
position to about the 2 o'clock position. 
The removal tool 50 of the present invention, which is illustrated in FIGS. 
10-14, should be used at this stage of the procedure. The tool 50 has a 
tweezer body 52 with a normally open position, so that a squeezing force 
is required to bring the two arms thereof together. 
The removal tool 50 has gripping means mounted to each of the end, as best 
illustrated in FIG. 10. These gripping means consist of first and second 
saucer-shaped members 54, 56. The saucer-shaped members 54, 56 have a 
substantially circular shape as can be best appreciated from FIG. 12 and 
13. Additionally, as can be best seen in FIG. 14, each of the 
saucer-shaped members 54, 56 has a concave inner surface 58 and a convex 
outer surface 60. The saucer-shaped members 54, 56 also have a central 
opening 62. The saucer-shaped members 54, 56 are connected to the tweezer 
body 52 through curved offset portions 53, 55. 
The removal tool 50 preferably has an overall length of approximately three 
inches. The saucer-shaped members 54, 56 preferably have a diameter of 
approximately four millimeters and a "saucer" depth of approximately two 
millimeters. The central opening 62 should have a diameter of 
approximately one millimeter. The central opening 62 serves the function 
of releasing entrapped fluid or air between the tool and the lens. 
Returning now to the surgical procedure of the present invention, and 
referring to FIG. 1, after the capsulotomy is performed, the removal tool 
50 is used to fold back the superior portion of the capsular incision. In 
particular, the saucer-shaped member 54 is inserted between the posterior 
lens capsule 20 and the posterior surface of the lens 22, which has the 
effect of exposing the apex of the lens 22. The outer saucer-shaped member 
56 is inserted between the anterior lens capsule 18 and the anterior 
surface of the lens 22. The tool 50 is then squeezed so that the two 
saucer-shaped members grip the lens 22. The tool 50 is then manipulated by 
hand so as to rotate the lens 22 from clockwise and counterclockwise to 
dislodge the lens 22 from the capsule. The lens 22 is then lifted 
approximately half way out of the capsule with the removal tool 50. 
AT this time, an erisophake 26 is used to remove the lens 22 totally from 
the capsule. The squeezing pressure on the tweezer body 52 of the removal 
tool 50 is slightly released to keep the capsule open. The interior of the 
lens capsule is then irrigated with sterile saline solution. Thereafter, 
any capsular plaque is removed by means of suction. 
A new lens 22' may then be implanted well into the capsule with an 
erisophake 26. The lens implant 22' should be a suitable transparent, 
flexible, biologically inert, non-toxic, non-irritating material which is 
not susceptible to absorption by body fluids. Once the new lens 22' is 
seated well into the capsule, the removal tool 50 can be withdrawn. 
The superior capsule flap is then repositioned, as well as the iris 16. The 
anterior chamber of the eye is then irrigated. The corneal incisions and 
the conjunctival flaps are closed by means of sutures. Thereafter, 
distention of the anterior chamber takes place by means of air or fluid. 
It will be appreciated by those skilled in the art that post-operative 
medication such as neo-decadron ophthalmic ointment should be used to 
counteract infection and to promote healing. Additionally, a cycloplegic 
such as cyclopentolate should be instilled before the effects of local or 
general anesthesia wear off. The cyclopegic should be continued for a 
period of approximately one to two weeks. 
It will be appreciated that, with the procedure just described, it is 
possible to implant a natural human or animal lens within the human lens 
capsule, which will be totally surrounded by the lens capsule. The 
capsule, is turn, is held in position by the natural zonular fibers 
attached to the ciliary muscle. The change in contour and focus of the 
lens is accomplished by the natural constriction and relaxation of the 
ciliary muscles applying pressure to the lens implant. 
The present invention may also be used with an artificial lens and, in 
particular, a soft or flexible lens. Such a flexible lens can be made of 
the same type of material presently being used for external contact lenses 
such as HEMMA (hydrophilic plastic), M.M.A. (soft plastic), silicone (hard 
and soft plastic) and P.M.M.A. (hard plastic), with M.M.A. being the 
preferred material. 
It should also be appreciated that the implanted lens 22' of the present 
invention, whether flexible (and thus having a variable focus) or rigid 
(and thus having a fixed focus) may have a variety of sizes and shapes. 
Thus, FIG. 5 and 6 illustrate a convex lens 70 in plan view and in 
cross-sectional view respectively. FIG. 7 illustrates a plano convex lens 
72; FIG. 8 illustrates a modified plano-convex lens 74; and FIG. 9 
illustrates a bi-convex lens 76. The lens 22' should be approximately nine 
millimeters to thirteen millimeters in diameter and have a thickness of 
approximately 3.0 to 4.5 millimeters, all of which dimensions are variable 
depending upon the lens power required, the material used and the physical 
and anatomical limitations of the particular eye and the lens capsule. 
It will thus be appreciated that the present invention provides virtually 
complete and natural vision performance of the human or animal eye, since 
it utilizes the natural lens capsule (rather than destroy it or mutilate 
it), as well as the surrounding ciliary muscles and natural zonular 
fibers. It totally avoids the use of sutures, wedges, prongs and riveting 
devices which have a tendency to apply constant pressure and trauma to the 
surrounding tissue, thus causing irritation and inflammation. 
As will be readily apparent to those skilled in the art, the invention may 
be used in other specific forms without departing from its spirit or 
essential characteristics. The present embodiments are, therefore, to be 
considered as illustrative and not restrictive, the scope of the invention 
being indicated by the claims rather than the foregoing description, and 
all changes which come within the meaning and range of equivalence of the 
claims are therefore intended to be based therein.