Intraocular device for stabilizing of a lens capsule

Information

  • Patent Grant
  • 6183480
  • Patent Number
    6,183,480
  • Date Filed
    Thursday, May 13, 1999
    25 years ago
  • Date Issued
    Tuesday, February 6, 2001
    23 years ago
Abstract
A stabilizer and method of lens capsule retraction. The stabilizer includes a shaft, a stabilizing bend extending from the shaft, and a shank terminating at a termination end. The bend is between the shank and the shaft and is configured to provide a hook-like configuration. A distance between a trough of the stabilizing bend and the termination end is between 1.6 mm and 5.0 mm, preferably between 2.0 mm and 3.0 mm.
Description




STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT




Not Applicable.




BACKGROUND OF THE INVENTION




1. Field of the Invention




The invention relates to devices that stabilize the lens capsule during or after cataract removal.




2. Discussion of Related Art




The clouding of the human eye is referred to as “cataract.” Capsulorhexis involves tearing a generally circular opening (capsulotomy) through the anterior capsule of the capsular bag of the human lens. This opening or capsulotomy is bounded circumferentially by a continuous annular remnant edge of the anterior capsule, i.e., the edge is smooth and not jagged. During a cataract operation, the cataractous nucleus and cortex of the natural lens is removed from the capsular bag and an artificial lens implant is inserted into the bag through the capsulotomy.




Endocapsular tension rings are conventionally used to stabilize the lens capsule during cataract removal or after cataract removal. These rings consist of near circular plastic rings, which are inserted into the capsular sac that surrounds the human lens. These devices are currently used in the United States on an investigational basis and also abroad.




Iris retractors are used to enlarge the iris by retracting the same outwardly, thereby expanding the pupil, for the purpose of providing exposure of a cataract during cataract removal procedures. These retractors may be rigid or flexible, and each has an end configured into a hook. In particular, each has the characteristic of a relatively short shank length of approximately 1.0-1.25 mm, although there is a patent disclosure of a shank length between 1.0-1.5 mm. The shank length is the distance between the trough of the bend of the hook to the termination end of the hook's shank.




The inventor has used such iris retractors, which are used to retract the iris on a temporary basis, in an attempt to retract the lens capsule and has used them also to provide fixation to the lens capsule and enclosed cataract in numerous patients. However, the inventor found that such iris retractors provide non-constant fixation and frequently slip off the capsule so to render than unreliable for such use in retracting the lens capsule. Furthermore, such retractors do not restrain the peripheral regions of the capsule (the equatorial capsule). These regions are thus free to be attracted to various aspirating instruments used for cataract removal. The capsule may thus be easily damaged by such instruments.




BRIEF SUMMARY OF THE INVENTION




The present invention relates to a stabilizer or fixation device and method of lens capsule retraction. The stabilizer includes a shaft, a stabilizing bend extending from the shaft, and a shank terminating at a termination end. The bend is between the shank and the shaft and is configured to provide a hook-like configuration to the stabilizer. A distance between a trough of the stabilizing bend and the termination end is between 1.6 mm and 5.0 mm, preferably about 2.5 mm and between 2.0 mm and 3.0 mm.











BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING




For a better understanding of the present invention, reference is made to the following description and accompanying drawings, while the scope of the invention is set forth in the appended claims.





FIG. 1

is a perspective view of lens capsule stabilizer in accordance with a narrow variety embodiment of the invention.





FIG. 2

is a perspective view of lens capsule stabilizer in accordance with a wide variety embodiment of the invention.





FIG. 3

is an oblique cut-away side view of the human eye illustrating the internal condition of the ocular area after cataract extraction and lens capsule stabilization in accordance with the present invention.





FIG. 4

is a plan view of a conventional endocapsular tension ring used to stabilize the lens capsule and having a diameter of approximately 12 mm.





FIG. 5

is a cut-away side view of a conventional iris retractor used to retract the iris.





FIG. 6

is a plan view of conventional iris retractor in position retracting the iris.











DETAILED DESCRIPTION OF THE INVENTION




Turning to the drawing,

FIG. 1

shows a narrow variety fixation device or stabilizer


10


and

FIG. 2

shows a wide variety fixation device or stabilizer


30


. Both stabilizers


10


,


30


, in accordance with the invention, share some common features.




Each includes a shaft


12


, a stabilizing bend


14


, and a shank


16


. The stabilizing bend


14


has a trough


18


and the shank


16


terminates at a termination end


20


.




The stabilizing bend


14


is between the shaft


12


and the shank


16


and changes a direction of orientation of the device


10


into a generally hook configuration. A length L, as measured between the trough


18


and the termination end


20


, is between 1.6 mm and 5.0 mm, preferably between 2.0 mm and 3.0 mm. Such a length is desired so that the shank


16


extends to the capsular equator when in position.




In the case of the narrow variety stabilizer


10


of

FIG. 1

, preferably, the shaft


12


and shank


16


extend in a direction that is parallel or substantially parallel to each other. Further, a space S separates the shank


16


from the shaft


12


by an amount at least sufficient to fit the ocular tissue thickness at the boundary of the capsulotomy. Also, a width W between outer facing edges of the shaft


12


and shank


16


that face away from each other is within a range of 0.4 mm to 1.0 mm to fit while passing through confines of narrow incisions. Alternatively, the device may be made of a malleable material which permits it to temporarily collapse and deform during insertion through a small incision.




In the case of the wide variety stabilizer


30


of

FIG. 2

, the shaft


12


and the shank


16


are arranged to extend relative to each at an oblique angle A. The width between the outer facing edges of the shaft


12


and the shank


16


needs to be of a dimension that fits while passing through confines of conventional wide incisions.




A difference between the embodiments of

FIGS. 1 and 2

is that in the case of the narrow variety embodiment of

FIG. 1

, the stabilizing bend


14


has a curvature configured to position the hook end


16


to extend in a direction substantially parallel to that of the shaft


12


. Both the shaft


12


and the hook end


16


of the stabilizer


10


are straight. In the case of the wide variety embodiment of

FIG. 2

, the stabilizing bend


14


has a curvature configured to position the hook end


16


to extend at an oblique angle relative to the shaft


12


. Both the shaft


12


and the hook end


16


are straight.




As shown in

FIG. 3

, the lens


42


is surrounded by a lens capsule


40


. The lens capsule


40


is surgically cut in any medically safe conventional manner to form a conventional capsulotomy


44


or surgical opening during cataract removal and lens implantation procedures. The capsulotomy


44


has a continuous, unbroken edge forming its boundary and should not be jagged. Also shown are other components of the eye, such as the iris


50


, ciliary body


52


, and zonule


54


.




The zonule


54


consists of numerous small fibers which course from the ciliary body


52


to the equatorial region of the lens capsule. The zonule


54


provides anatomic support for the lens capsule and contained lens, but may become weakened due to aging, trauma or a number of ocular disorders. When weakened, the zonule fails to provide adequate support to the capsule, and this may cause great difficulty during cataract surgery. For example, if not adequately restrained and supported, the capsule may be attracted to various aspirating instruments used during cataract removal and thereby damaged. Subsequent to this, portions of the cataract may fall through these damaged regions into the back or posterior portion of the eye, resulting in postoperative inflammation, glaucoma, additional procedures to retrieve and remove them, etc. As stated earlier, endocapsular tension rings are currently used to produce tension on the equatorial lens capsule either during and/or after cataract removal. When used during cataract removal, however, the inventor observed that these devices have certain disadvantages and shortcomings that are overcome by the use instead of the stabilizers


10


and


30


of the present invention.




The stabilizers


30


are arranged in a position to stabilize the lens capsule


40


. The shanks


16


of the stabilizers


30


are shown in

FIG. 3

to extend to the capsular equator.




The physician uses judgment to select either the narrow variety stabilizer


10


or the wide variety stabilizer


30


or both. The relative location and dimension of the incision


46


that the applicable stabilizer is to penetrate with respect to the boundary of the capsulotomy


44


may factor into which stabilizer is the more suitable one to use.




With the stabilizers in position such that the shank


16


is within the underside of the lens capsule


40


and the shaft


12


is outside of the lens capsule


40


, the stabilizer


10


,


30


is moved relative to the lens capsule until the bend


14


engages the boundary of the capsulotomy


44


. For this reason, a distance S is critical to allow a portion of the lens capsule


40


that is adjacent the capsulotomy to fit within the space S. Any number of stabilizers


10


,


30


may be used in this manner to firmly hold the boundary of the capsulotomy with the bend


14


and may apply pressure to the boundary to stabilize the lens capsule.




The amount of the pressure applied is roughly the same as that applied to retract the iris with iris retractors, but is exerted in accord with sound medical practice to avoid damaging the lens capsule. Once a sufficient amount of pressure is applied to stabilize so that the stabilizers


10


,


30


are in their appropriate position, the stabilizers may be held in place at their shafts


12


with the same type of holders that hold iris retractors in place.





FIG. 4

shows a conventional capsular tension ring


60


used to stabilize the lens capsule during or after cataract removal. Such a ring


60


is no longer needed during cataract removal in accordance with the use of the stabilizers


10


,


30


of the present invention, which stabilize the cataract and the surrounding lens capsule during removal of the cataract. U.S. Pat. No. 5,843,184, entitled ENDOCAPSULAR TENSION RING AND METHOD OF IMPLANTING THE SAME, reveals an exemplary endocapsular tension ring.




In addition, the stabilizers


10


,


30


provide greater stability to the lens capsule


40


of FIG.


3


and the enclosed cataract than does the capsular tension ring


60


. This is because the endocapsular tension ring provides only an outward force on the lens capsule, but provides no support for the capsule and enclosed cataract. The capsule and the enclosed cataract are therefore not prevented from shifting downward toward the back of the eye, nor are they prevented from undesirably rotating during the process of cataract removal. Such downward shifting or rotation adds greatly to the difficulty of cataract removal, and further weakens the attachments (zonule) of the lens capsule to the ciliary body. The stabilizers


10


,


30


of the present invention simultaneously support the capsule and enclosed cataract and restrict rotation of the capsule caused by torsional forces which are routinely applied to the enclosed cataract by the surgical instruments used for cataract removal.




Furthermore, endocapsular tension rings have the disadvantage of trapping cataractous lens material (lens cortex) between themselves and the peripheral regions of the capsule against which they exert pressure. This makes lens cortex removal much more difficult and adds to the trauma of the procedure. The stabilizers


10


,


30


of the present invention do not trap lens cortex in any manner. Such was observed by the inventor, who has performed literally tens of thousands of cataract operations.




Indeed, the inventor found that the stabilizers


10


,


30


of

FIGS. 1 and 2

permit the lens capsule


40


of

FIG. 3

to become hooked and firmly held so as to provide support to the capsular equator, following the creation of the circular surgical opening in the lens capsule commonly called the capsulotomy


44


. Preferably, by arranging multiple stabilizers each constructed in accordance with that of either

FIGS. 1

or


2


, the lens becomes stabilized.




The present inventor observed that such stabilizers of the embodiments of

FIGS. 1 and 2

should have a length of the shank


16


between 1.6 mm and 5.0 mm, preferably between 2.0 mm and 3.0 mm, as measured between the trough


18


of the stabilizing bend


14


and the termination of the hook end


16


. A shank length of about 2.5 mm or exactly 2.5 mm is satisfactory. Such stabilizers


10


,


30


having such a length have never been used previously in connection with any eye surgical procedure as far as the inventor is aware, because they have no perceived usefulness in the field.




A conventional stabilizer with a shank length between 1.0 mm and 1.25 mm has been used by the present inventor in an effort to stabilize the lens capsule. The present inventor found the use of multiple ones of them to be unreliable in that they frequently slip off the capsule and provide non-constant fixation because of their short shank length. Such stabilizers are typically used as iris retractors


70


in the manner shown in

FIGS. 5 and 6

to retract the iris


46


on a temporary basis.




The shafts of the iris retractors


70


are each held in position by a holder


71


, which may be a resilient material having two openings that align with each while the resilient material is bent to accommodate insertion of the shaft through both openings. The resilient material need only be squeezed to permit its relative movement along the length of the shaft. Also shown in

FIG. 6

is the sclera


72


and the transition


74


between the iris and the sclera


72


.




The stabilizer


10


,


30


of the embodiments of

FIGS. 1 and 2

may be made of the same materials as a conventional retractor


70


of FIG.


5


and may be either flexible or rigid. Such a conventional iris retractor is revealed in U.S. Pat. No. 5,716,328, whose contents are incorporated herein by reference as concerns its disclosure of materials of the iris retractor and manner of manufacture of the same.




The phrase “about 2.5 mm” means 2.5 mm plus or minus 0.2 mm. The phrases “between 1.6 mm and 5.0 mm” and “between 2.0 mm and 3.0 mm)” are inclusive of the endpoints of these ranges. The shaft length is many multiple times the length of the shank. Further, the shank, bend and shank need to be sterilized to minimize the risk of contamination when in use. The phrase “enclosed cataract” refers to the cataractous lens material that is contained within the lens capsule.




While the foregoing description and drawings represent the preferred embodiments of the present invention, it will be understood that various changes and modifications may be made without departing from the spirit and scope of the present invention.



Claims
  • 1. An intraocular device to stabilize ocular tissue during and after removal of a cataract comprising an elongated shaft, a bend, and an elongated shank, the bend being arranged between the shaft and the shank and defining a trough and configured so that a length between the trough and a termination end of the shank is between 1.6 mm and 5.0 mm, the shaft being longer than said shank, said shaft and said shank being spaced from each other, whereby said intraocular device is for stabilizing ocular tissue during and after removal of a cataract.
  • 2. A device as in claim 1, wherein the length is between 2.0 mm and 3.0 mm.
  • 3. A device as in claim 1, wherein the length is about 2.5 mm.
  • 4. A device as in claim 1, wherein the shank extends in a linear manner from the bend to the termination, the bend defining an oblique angle between the shaft and the shank.
  • 5. A device as in claim 1, wherein the shaft, the bend and the shank are in a sterilized condition.
  • 6. A device as in claim 1, wherein the shank extends in a linear manner from the bend to the termination, the bend defining an angle between the shaft and the shank such that the shaft and the shank extend substantially parallel with each other.
  • 7. A method of stabilizing an ocular tissue during and after removal of the cataract, the eye having a lens capsule with a capsulotomy whose periphery defines a surgical opening in a lens capsule of the eye, the eye having a cornea with a periphery having an incision, the method comprising the steps of:arranging an elongated shaft of a stabilizer to penetrate through the incision from outside the cornea, the stabilizer being configured to stabilize the lens capsule; and hooking a margin of the capsulotomy in a lens capsule with the stabilizer to stabilize the lens capsule, the stabilizer having a bend arranged between the shaft and an elongated shank of the stabilizer, the shaft and the shank being spaced from each other, the bend having a trough, the shank having a termination end arranged so that a distance between the trough and the termination end is between 1.6 and 5.0 mm.
  • 8. A method as in claim 7, wherein the length is between 2.0 mm and 3.0 mm.
  • 9. A method as in claim 7, wherein the length is about 2.5 mm.
  • 10. A method as in claim 7, wherein the shank extends in a linear manner from the bend to the termination, the bend defining an oblique angle between the shaft and the shank.
  • 11. A method as in claim 7, wherein the shank extends in a linear manner from the bend to the termination, the bend defining an angle between the shaft and the shank such that the shaft and the shank extend substantially parallel with each other.
  • 12. A method as in claim 7, wherein the shaft, the bend and the shank are each in a sterilized condition before penetration through the incision.
CROSS-REFERENCE TO RELATED PATENT APPLICATIONS

Provisional patent application Ser. No. 60/128,836, filed Apr. 9, 1999.

US Referenced Citations (8)
Number Name Date Kind
4573998 Mazzocco Mar 1986
5174279 Cobo et al. Dec 1992
5267553 Graether Dec 1993
5451230 Steinert Sep 1995
5514076 Ley May 1996
5716328 Grieshaber et al. Feb 1998
5807244 Barot Sep 1998
5843184 Cionni Dec 1998
Provisional Applications (1)
Number Date Country
60/128836 Apr 1999 US