JP2003533271A - Injectable fixed iris intraocular lens - Google Patents

Abstract

(57) Abstract: Refractive anterior chamber iris fixation type including a visual part having an outer peripheral edge and two or more (preferably two, three or four) balanced tactile elements Intraocular lens. Each haptic element is manufactured to have an inner portion and an outer free end portion for supporting the optic in the patient's eye. The inner part of each haptic element is preferably permanently joined to the outer peripheral edge of the optic. Each haptic element also includes an opening through a fixed clamp to be attached or a fixed clip to be connected.

Description

Detailed Description of the Invention

FIELD OF THE INVENTION The present invention relates to intraocular lenses (IOLs) and methods of making and using the intraocular lenses. More particularly, the present invention relates to an anterior chamber iris fixed IOL designed primarily for refractive correction in the phakic eye where the natural lens of the eye remains intact.

BACKGROUND OF THE INVENTION Myopia (myopia), hyperopia (hyperopia), vision loss such as presbyopia (senile hyperopia), aphakia (absence of lens of the eye) and astigmatism (cornea of the eye). Are usually corrected by the use of refractive lenses such as spectacles or contact lenses. While these types of lenses are effective in correcting the wearer's vision, many wearers find these lenses inconvenient. These lenses must be positioned, worn at specific times, periodically removed and can be lost or misplaced. These lenses can also be dangerous and annoying when the wearer during exercise is active or impacted on the peripheral area of the eye.

The use of surgically implanted anterior chamber IOLs as a permanent form of refractive correction has been generally accepted. IOL implants have long been used in the anterior or posterior chamber of the aphakic eye as a replacement for the diseased native lens surgically removed from the eye.
Many different IOL designs have been developed over the years and have proven successful for use in the aphakic eye. The effective IOL designs to date mainly consist of a visual part and a support for the visual part, which is joined to and surrounds at least part of the visual part (haptics and haptics). Called). The haptic part of the IOL is designed to support the optic part of the IOL in the lens capsule, anterior or posterior chamber of the eye once implanted.

Commercially successful IOLs are made from more rigid materials such as polymethylmethacrylate (PMMA) to softer flexible materials that can be folded or compressed such as silicones, certain acrylics, and hydrogels. Are formed from a variety of biocompatible materials, ranging from The haptics of the IOL have been formed separately from the optic and then subsequently joined to the optic via processes such as heat, physical staking and / or chemical bonding. The haptics have also been formed as an integral part of the optic, commonly referred to as the "single-piece" IOL.

Softer and more flexible IOLs have been popular in recent years due to their ability to be compressed, folded, rolled, or otherwise deformed. Such a soft IOL may be deformed and then inserted through an incision in the cornea of the eye. After insertion of the IOL into the eye, the IOL returns to its original pre-deformed shape due to the memory properties of the soft material. A softer, more flexible IOL, as described, is a much smaller incision (ie, 4.8-6.0 mm) than that required for a stiffer IOL (ie, 4.8-6.0 mm).
That is, it can be implanted in the eye by 2.8-3.2 mm). Larger incisions are needed for stiffer IOLs. This is because the lens must be inserted by a corneal incision slightly larger than the diameter of its inflexible IOL optic. Therefore, stiffer IOLs are not well received in the market. Because large incisions have been found to be associated with an increased incidence of postoperative complications (eg, induced astigmatism).

[0006] Following IOL implantation, both softer and more rigid IOLs that are placed within the anterior chamber angle of the eye are the outer, typically occurring when an individual narrows or rubs the eye. Subjected to the compressive force exerted on the edge. In either the aphakic or phakic eye, such compressive forces on the IOL placed in the comer may cause tissue damage, decentration of the IOL and / or distortion of the image. Can happen. The compressive force on the IOL placed in the corner is also
Movement of the OL haptic and axial movement of the IOL along the visual axis of the eye (axial disp
liquor). Tactile transfer and wide tactile contact in the anterior chamber angle of the eye results in delicate eye structures (eg, peripheral corneal endothelium,
Traumatic meshwork and / or iris). Movement of the IOL along the visual axis of the eye has the potential for the IOL to contact and damage the delicate eye's corneal endothelial cell layer. Also, the IOL placed in the corner of the current design is
Whether formed from a softer or stiffer material, the haptics tend to distort along the visual axis of the eye when compressed. IOL manufacturers offer a wide range of IOL sizes to better fit the IOL to the size of each particular patient's eye. Providing a wide range of IOL sizes is an attempt to minimize the possibility of tactile compression and its associated axial displacement of the IOL vision along the visual axis of the eye.

Due to a notable drawback of current IOL designs, it eliminates tactile contact and movement in the anterior chamber angle when the compressive force is exerted on its outer edge, and the visual axis of the eye. There is a need for aphakic and phakic anterior chamber IOLs designed to eliminate axial movement of the IOL optic along the eye. By eliminating tactile and IOL visual movements of the respective IOLs in the anterior corner and the anterior chamber of the eye, a more specific refractive correction may be achieved and the risk of delicate tissue damage may be reduced.

SUMMARY OF THE INVENTION An intraocular lens (IO) of the iris fixation type anterior chamber that is made according to the present invention
L) has a optic with an outer peripheral edge and two or more (preferably two, three or four) haptic elements for supporting the optic in the patient's eye.
Two, three or four haptic elements are preferred in the present invention to provide a balance between IOL stability and minimizing fixation points on the iris. A lens with two haptic elements is balanced by having one haptic element formed on one edge of the optic and a second haptic element formed on the opposite edge of the optic. Or stabilized. A lens with three haptic elements was formed on the opposite edge of the optic, which was easily passed through two spaced haptic elements and an inserter formed on one edge of the optic. Having a third tactile element is preferably balanced or stabilized. Alternatively, a lens with three haptic elements can be balanced or stabilized by using three haptic elements, each of which is equally spaced around the circumference of the optic. A lens with four haptic elements is formed on the opposite edge of the optic for easy passage through the two spaced haptic elements and the inserter formed on one edge of the optic. It is preferably balanced or stabilized by having two spaced haptic elements. Alternatively, a lens with four haptic elements can be balanced or stabilized by using four haptic elements, each of which is evenly spaced around the circumference of the optic. Each haptic element on the visual part is preferably easily foldable, rollable and / or compressible, in order to implant the IOL into the eye through a relatively small incision, preferably with an inserter Arc-shaped stretched or plate-like configurations designed to. A corner haptic element having a mounting opening is manufactured and IO is attached to the front of the iris of the eye.
For ease of securely attaching L, it is preferably centered on the outer free end portion. Each haptic element also has an inner portion opposite the outer free end portion. The inner portion of the haptic element is preferably connected or integrally formed with the outer peripheral edge of the visual portion of the IOL. Each haptic element includes a locking clamp that fits through a mounting opening formed in the outer free end portion or a locking clip extending from the mounting opening. The fixation clamps and clips are designed to secure the IOL within the anterior chamber of the eye by securely engaging the relatively immobile outer peripheral edge of the iris of the eye.

Accordingly, it is an object of the present invention to provide an intraocular lens for use in aphakic and phakic eyes.

Another object of the present invention is to provide an intraocular lens for use in aphakic and phakic eyes that eliminates anterior chamber angle contact.

Another object of the invention is to provide an intraocular lens for use in aphakic and phakic eyes that minimizes axial movement of the optic part of the lens along the visual axis of the eye. That is.

Another object of the invention is to provide an intraocular lens that allows for increased ease of implantation of the intraocular lens.

Another object of the present invention is to provide an intraocular lens that allows implantation with an inserter.

Another object of the present invention is to provide an intraocular lens for use in aphakic and phakic eyes that minimizes damage to tissues inside the eye.

Yet another object of the present invention is to provide an intraocular lens that resists decentering within the eye.

These and other objects and advantages of the invention, some of which are described in detail and others not, will be apparent from the following detailed description, drawings and claims. . Here, similar features are indicated by similar numbers. DETAILED DESCRIPTION OF THE INVENTION FIG. 1 shows a simplified view of an eye 10 showing target structures associated with implantation of an intraocular lens of the present invention. The eye 10 includes an optically transparent cornea 12 and an iris 14 having a relatively immobile peripheral edge 40. The natural lens 16 and retina 18 are located behind the iris 14 of the eye 10. The eye 10 also includes an anterior chamber 6 having a comer angle 7 located in front of the iris 14 and a posterior chamber 8 located between the iris 14 and the natural lens 16. An IOL 26, such as the IOL of the present invention, is preferably implanted in the anterior chamber 6 to correct refractive errors, while leaving the healthy native lens 16 intact (
Phakic applied). However, the IOL 26 may also be implanted in the anterior chamber 6 of an aphakic eye in which the original lens 16 has been removed. The eye 10 also includes a visual axis OA-OA, which is an imaginary line passing through the optical center 20 of the anterior surface 22 and posterior surface 24 of the lens 16. The visual axis OA-OA in the human eye 10 is substantially perpendicular to the cornea 12, the natural lens 16 and a portion of the retina 18.

As best described in FIGS. 2, 4, 6 and 13-15, identified by reference numeral 26, the IOL of the present invention comprises an anterior chamber 6 of an aphakic or phakic eye 10 of a patient. Designed for porting to. The IOL 26 has a optic 28 having an outer peripheral edge 30. Preferably, integrally formed on the outer peripheral edge 30 of the optic portion 28 is two or more (but preferably two, three or four) discrete arcuately stretched or plate-like. The tactile element 32. Each tactile element 32
Is manufactured to have an inner portion 34 and an outer free end portion 36. The inner portion 34 of the haptic element 32 is preferably integrally formed on the outer peripheral edge 30 of the optic 28 and is permanently joined to the outer peripheral edge 30 thereof. Alternatively, however, the inner portion 34 of the haptic element 32 may be attached to the visual portion 28 by staking, chemical polymerization, or other methods known to those of skill in the art. Each haptic element 32 also includes a locking clamp 38 or alternatively a locking clip 39 designed to engage a relatively immobile outer peripheral edge 40 of the iris 14 in the anterior chamber 6.
At the outer free end portion 36. In accordance with the present invention, IOL 26 has an iris 1
It is held in place in the anterior chamber 6 via a constant compressive force exerted by a fixed clamp 38 or a fixed clip 39 on the relatively non-moving outer peripheral edge 40 of 4. Iris fixation of the IOL 26 is required to prevent the tactile sensation 32 from contacting and damaging the delicate tissue within the angle 7 of the eye 10.

The functional characteristics of the haptic element 32 required to maintain sufficient compressive force on the iris 14 are achieved by its unique design. The IOL 26 is shown in FIGS.
4 and 5 each formed with an arcuately stretched haptic element 32 or those haptic elements as illustrated at 15 and 15 with a suitably sized mounting opening 44 therethrough. A plate-like haptic element 3 as illustrated at 14.
2, the fixation clamp 38 is positioned via an appropriately sized attachment opening 44 either before or after implantation of the IOL 26 in the eye 10, and is shown in FIGS.
And 9 includes two mating smooth, serrated or toothed edges 80. The smooth, serrated or toothed edge 80 of the fixed clamp 38 may be separated along the surfaces 48-48 by inserting the tip 92 of the surgical retractor 90 illustrated in FIG. 12 into the inner edge 83. , Or can be spread. The inner edge 83 defines the central opening 50 of the fixed clamp 38. The smooth, serrated or toothed edge 8 is then opened by opening or spreading the tips 92 of the retractor 90 by the force of moving the handles 94 into contact with each other.
0 is opened. Alternatively, the smooth, serrated or toothed edge 80 of the fixed clamp 38 may be used in similar fashion with similar surgical tools and techniques in a shear manner to provide a surface 46-4.
It can be separated or spread out along 6. Similarly, the smooth, serrated or toothed edge 80 of the fixed clamp 38 positions the spaced apart tip 98 of the surgical tweezers 96 as shown in FIG. 11 on the outer edge 81 of the fixed clamp 38. Can be separated or spread by. The compressive force then causes the surgical tweezers 96 to attempt to bring the spaced apart tips 98 closer together.
Applied to the handle 95 of the. The compressive force applied by the tip 98 spaced against the outer edge 81 of the fixed clamp 38 opens the smooth, serrated or toothed edge 80. Once the smooth, serrated or toothed edges 80 have been separated or opened, the edges 80 are relatively immobile peripheral edges 40 of the iris 14.
It can be placed on or touched and returned to its original closed position. Upon closing, the smooth, serrated or toothed edge 80 pinches or pierces the relatively immobile peripheral edge 40 of the stationary iris 14 for reliable and secure attachment. Preferably, the smooth, serrated or toothed edges 80 of the fixation clamp 38, when fixed to the iris 14 for better tolerance by the iris 14 and easy surgical manipulation during the clamping process. It is oriented in a plane perpendicular to the ten visual axes OA-OA. Since the fixed clamp 38 has a relatively small size, I
The OL 26 can be implanted in the eye 10 with an inserter without peeling the fixed clamp 38 through a relatively small incision (eg, less than 4.0 mm). However, the locking clamp 38 may be positioned as desired via the mounting opening 44 after implantation of the IOL 26.

As an alternative to utilizing the locking clamp 38 for stabilizing the IOL 26, a locking clip 39 as illustrated in FIGS. 13-15 may be utilized. The locking clip 39 is formed on the outer free end portion 36 of the haptic element 32 and extends from the mounting opening 44 to the free end 100. The securing clip 39 has two smooth, serrated or toothed edges 102 for attachment to a relatively immobile peripheral edge 40 of the iris 14. The smooth, serrated or toothed edge 102 of the fixation clip 39 is attached to the attachment opening 44 to the surgical retractor 90 illustrated in FIG.
Can be separated or unrolled along surfaces 48-48 by inserting the tip 92 of the. The smooth, serrated or toothed edge 102 is then opened by opening or spreading the tip 92 of the retractor 90 with the force of moving the handles 94 toward one another. Alternatively, the fixing clip 39 may be smooth,
The serrated or toothed edges 102 can be separated or spread along surfaces 46-46 in a shear fashion using similar surgical tools and techniques. Similarly, the smooth, serrated or toothed edge 102 of the securing clip 39 is
00 free end 9 of surgical forceps 96 as illustrated in FIG.
They can be separated or spread by placing 8. The spaced apart tips 98 are arranged such that the mounting openings 44 are located between the tips.
The surgical tweezers 96 are then placed so that the spaced tips 98 are closer together.
A compressive force is applied to the handle 95 of the. The compressive force applied to the free edge 100 of the securing clip 39 by the spaced tip 98 acts to open the smooth, serrated or toothed edge 102. Once the smooth, serrated or toothed edge 102 is separated, the edge 102 may be placed on or contacted with the relatively immovable peripheral edge 40 of the iris 14 and then closed. You can return to the assigned position. Upon closing, the smooth, serrated or toothed edge 102 provides a relatively immobile peripheral edge 4 of the iris 14 for reliable and secure attachment.
Insert 0 or stab. Preferably, the smooth, serrated or toothed edge 102 of the fixation clip 39 is better secured by the iris 14 and when secured to the iris 14 for easier surgical manipulation during the fixation process. Visual axis OA-
It is oriented in a plane perpendicular to the OA. Since the fixation clip 39 is formed in the haptic element 32, the IOL 26 can be easily implanted in the eye 10 with an inserter via a relatively small incision (eg, less than 4.0 mm).

The target IOL 26 preferably has a diameter of about 4.5 to 9.0 mm, but preferably about 5.0 to 6.5 mm, and most preferably 5.5 mm, and about 0.5 mm to. Manufactured with a optic portion 28 of 1.0 mm, but preferably about 0.6-0.8 mm, and most preferably 0.7 mm thick at the peripheral edge 30. Haptic element 32 extends in a substantially arcuately elongated or plate-like shape, and increases or decreases in length depending on the diameter of optic portion 28. As the diameter of optic portion 28 increases, the length of haptic element 32 decreases. Similarly, as the diameter of optic portion 28 decreases, the length of haptic element 32 increases. Generally, the haptic element 32 is about 2.6-6.0 mm, but preferably about 3.4-5.
． It is formed to be 0 mm, and most preferably about 4.2 mm long.
This length is obtained by measuring from the center of the inner portion 34 to the central tip 82 of the outer free end portion 36. The overall diameter of the IOL 26 is about 6.0-10.0 mm, but preferably about 7.0-9.0 mm, and most preferably about 8.0 mm. The haptic element 32 is preferably curved as illustrated in FIGS. 3, 5 and 7 such that the optic 28 is placed in a plane different from, but parallel to, the plane of the central tip 82 of the haptic element 32. Is preferred. Such curvature of the IOLs 26 allows their proper fixation relative to the relatively immobile peripheral edge 40 of the iris 14, while contacting the posterior surface 76 of the optic 28 with the moving portion 9 of the iris 14. It is possible to prevent.
A curvature of about 0.5-1.0 mm (measured between the posterior surface 76 of the optic 28 and the central tip 82 of the haptic element 32) centers the IOL 26 between the iris 14 and the corneal endothelium 4. Is preferred. The arcuately elongated haptic element 32 as illustrated in FIGS. 2 and 6 is about 0.5-2.5 mm, but preferably about 1.0-2.0 m.
m, and most preferably 1.6 mm in length; about 0.2 at faces 46-46.
.About.1.0 mm, but preferably about 0.3 to 0.7 mm, and most preferably about 0.46 mm, and about 0.5-2.
A width of 0 mm, but preferably about 0.75 to 1.75 mm, and most preferably about 0.75 to 1.50 mm. The arcuate plate-like haptic element 32 as illustrated in FIG. 4 is about 0.5-2.5 mm, but preferably about 1.0-.
2.0 mm, and most preferably 1.6 mm long; at faces 46-46,
A thickness of about 0.2-1.0 mm, but preferably about 0.3-0.7 mm, and most preferably about 0.46 mm, and about 0.1-3 at faces 48-48.
． 0 mm, but preferably about 0.2-2.5 mm, and most preferably
It varies in a width of about 0.2 to 2.0 mm. The fixed clamp 38 is preferably manufactured in a generally toroidal configuration. The outer diameter is about 0.2 to 1.0 mm, but preferably about 0.4 to 0.6 mm, and most preferably about 0.5 mm, and the inner diameter is about 0.05 to 0.5 mm. However, preferably about 0.1-0.4 mm,
And most preferably it is about 0.3 mm. The cross-sectional diameter of the fixed clamp 38 is
Preferably about 0.1 to 0. 0 over its entire length to ensure sufficient strength.
3 mm, but most preferably about 0.2 mm. The diameter of the mounting openings 44 may be the same or different, and preferably about 0.125-0.
5 mm, but most preferably about 0.225 mm. The lengths of the securing clips can be the same or different and are preferably about 0.1-0.3 mm, but most preferably about 0.2 mm to ensure sufficient strength.

The desired functional properties of IOL 26 may also be achieved by incorporating stiffening element 60 in the form of a ribbon in one or more haptic elements 32, as shown in FIG. 10, or Can be enhanced. The stiffening element 60 may be disposed within the haptic element 32 so that the plane 62 is oriented parallel to the surfaces 48-48. The stiffening element 60 functions in a manner similar to an I-beam constructed to prevent movement of the IOL 26 along the visual axis OA-OA. The stiffening element 60 is formed from a material that is less flexible than the IOL 26. Suitable materials for the curing element 60 include, but are not limited to, polyimide, polyolefin, high density polyethylene, polyester, nylon, metal or any biocompatible material having suitable curing properties. The stiffening element 60 is the tactile element 32 described above.
Can be used in combination with or where a thinner haptic design is desired while still achieving the desired functional properties.

Suitable materials for the production of the desired IOL 26 include foldable or compressible materials such as silicone polymers, hydrocarbon polymers and fluorocarbon polymers, hydrogels, soft acrylic polymers, polyesters, polyamides, polyurethanes, hydrophilics. Silicone polymer having a polymerizable monomer unit,
(But not limited to) fluorine-containing polysiloxane elastomers, as well as combinations thereof. IO
L26 is preferably of biocompatible material design, where the visual portion 28
And as much of the haptic element 32 as possible is compressible or foldable material (2-hydroxyethylmethacrylate (HEMA) and 6-hydroxyhexylmethacrylate (HOHEXAMA) or poly (HEMA-co-H).
OHEXMA) and not limited to silicone materials or hydrogel materials). The haptic elements 32, or at least a portion thereof (including the retaining clip 39 if the retaining clip 39 is formed therein), are made of a relatively rigid material (eg, a relatively rigid hydrogel, polymethylmethacrylate (PMMA).
) Or polyimide, but is not limited thereto, but is preferably PMMA due to its availability). Another optional IOL 26 as illustrated in FIGS. 4 and 14 is US Pat. No. 5,217,491.
No. 5,326,506, each of which is incorporated herein by reference in its entirety. In such cases, at least a portion of the optic 28 and haptic element 32 may be foldable or compressible (eg, silicone polymers, hydrocarbon polymers and fluorocarbon polymers, hydrogels, soft acrylic polymers, polyesters, polyamides, polyurethanes). , A silicone polymer having hydrophilic monomer units, a fluorine-containing polysiloxane elastomer, and combinations thereof, but are not limited thereto. The remaining outer free end portion 36 of the haptic element 32 (including the retaining clip 39 if formed therein) is made of a relatively stiff material (eg, a relatively stiff hydrogel, PM).
Manufactured by, but not limited to MA or polyimide). Relatively rigid hydrogels, PMMA, polyimides, suitable strong composites or suitable metals, such as, but not limited to, surgical steel or titanium, are preferred for the manufacture of the fixed clamp 38. Poly (HEMA-co-
HOHEXMA) due to its equilibrium water content of about 18% by weight and a high refractive index of about 1.474, which is greater than the refractive index of aqueous humor of the eye (ie 1.33), It is the preferred material for manufacturing the visual portion 28 of the IOL 26. High index of refraction is a desirable feature in the manufacture of IOLs to provide high optical power with minimal optical thickness. By using a material with a high index of refraction, the correction can be made using an IOL with less vision loss. Thin IOLs (eg, IOLs such as IOL26) are particularly desirable in phakic applications to minimize potentially harmful contact between IOL26 and iris 14 and / or corneal endothelium 4. Poly (HEMA-co-HOHEXMA) is also a desirable material in the manufacture of IOL26 due to its mechanical strength, which is suitable for withstanding significant physical manipulation. Poly (HEMA-co-HOHEXMA) also has the desired storage properties suitable for IOL26 use. Poly (HEMA-co-H
I made from materials with good memory properties, such as OHEXMA)
The OL 26 opens into its predetermined shape in the eye 10 in a controlled manner rather than explosively. Explosive opening of IOL 26 is undesirable due to potential damage to delicate tissue in the eye. Poly (HEMA-co-H
OHEXMA) is also dimensionally stable in the eye 10.

Although the teachings of the present invention apply to soft or collapsible IOLs 26 that are preferably formed of collapsible or compressible material, the teachings of the present invention also apply to relatively small incisions or inserters (eg, books). US Pat. Nos. 5,873,879, 5,860,986 and 5,810, which are incorporated by reference in their entireties.
Rigid and inflexible lens formed of one or more relatively rigid materials such as, but not limited to, polymethylmethacrylate (PMMA), when implantation via (e.g. Can be applied to.

The optic portion 28 of the IOL 26 may be a positive powered lens of 0 to about +40 diopters or a negative powered lens of 0 to about -30 diopters. The optic 28 may be biconvex, planoconvex, planoconcave, biconcave or uneven (meniscus), depending on the ability needed to achieve the appropriate central and peripheral thicknesses for effective operation. Can be.

The visual portion 28 of the target IOL 26 may be positioned so that the outer peripheral edge 30 of the IOL 26 is located in the eye 1 during highlighting, or at other times when the pupil 58 is dilated.
When exposed to 0 light, adjacent the outer peripheral edge 30 to reduce glare, about 0.25 to 0.75 mm, but more preferably about 0.3 to 0.6 m.
m, and most preferably with a width of 0.5 mm, may be formed with the glare reducing region 56. The glare reduction region 56 is typically made of the same material as the visual portion 28, but is opaque, roughened and textured in the conventional manner for blocking or diffusing light in the plane having the visual axis OA-OA. And can be colored or patterned. The IOL 26 of interest and, if desired, a separate fixed clamp 38 can be molded using removable molds known to those skilled in the art. Alternatively, the IOL 26 and, if desired, a separate clamp 38 are first described in US Pat. Nos. 5,217,491 and 5,326,506, each of which is herein incorporated by reference in its entirety. Can be made by making discs from one or more materials of choice as described in US Pat. The IOL 26 and, if desired, a separate stationary clamp 38 can then be machined from the disc of material in a conventional manner. Once machined, IOL 26 or IO with retaining clip 39
L26 and a separate fixed clamp 38 are provided by conventional methods known to those skilled in the art.
It can be polished, washed, and optionally assembled, if using fixed clamp 38, sterilized, and packaged.

The target IOL 26 is made by making an incision in the cornea 12 and inserting the IOL 26 into the anterior chamber 6 using an inserter, if desired, according to methods known to those of skill in the art.
Fixed clamp 3 through mounting opening 44 if not already assembled
8 and open the smooth, serrated or toothed edge 80 with a surgical instrument,
It is used in the eye 10 by closing the smooth, serrated or toothed edge 80 to allow pinching and / or piercing of the relatively immobile peripheral edge 40 and closing the incision.

Alternatively, the desired IOL 26 can be made by making an incision in the cornea 12 according to methods known to those of skill in the art, and preferably inserting the IOL 26 into the anterior chamber 6 using an inserter, if desired, and Allowing the serrated or toothed edge 102 to be opened with a surgical instrument and closing the smooth, serrated or toothed edge 102 to pinch and / or pierce the relatively immovable peripheral edge 40, It is then used on the eye 10 by closing the incision.

The IOL 26 of the present invention provides a refractive lens suitable for use in the anterior chamber 6 of the eye 10. IOL 26 is a haptic element 32 having functional features that minimize or eliminate axial movement of eye 10 along the visual axis OA-OA, and thereby delicate eye tissue (eg, trabecular meshwork 17 and corneal endothelium). 4) Includes lens contact at the comer 7 of the anterior chamber 6 to prevent damage to the eye. The IOL 26 (designed as described herein) is also advantageous because one or several lens sizes fit well into most size eyes 10. This is because the attachment position for the iris 14 may change slightly. By providing a "universal" lens as in the present invention, the comer angle 7 due to an improperly sized lens
The patient's clinical risk in is minimized. Similarly, the need for manufacturers to manufacture many sized IOLs that fit many sized eyes is eliminated, thus:
It reduces the manufacturing and inventory costs associated with them. Ophthalmologists also save time by eliminating the need to determine the size of each patient's eye, and the costs associated with maintaining a large inventory of lenses of various sizes.
Benefit from the target IOL 26.

While particular embodiments of the present invention have been shown and described herein, various modifications can be made without departing from the spirit and scope of the underlying inventive concept and the appended claims. It will be apparent to those skilled in the art that, except to the extent indicated by the ranges of, are not limited to the particular forms shown and described herein.

[Brief description of drawings]

FIG. 1 is a schematic illustration of the interior of a human phakic eye, including a native lens and a refractive IOL implanted within the anterior chamber of the eye.

FIG. 2 is a plan view of an IOL with two haptic elements made in accordance with the present invention.

[Figure 3]   3 is a side view of the IOL of FIG.

FIG. 4 is a plan view of an IOL with three haptic elements made in accordance with the present invention.

[Figure 5]   FIG. 5 is a side view of the IOL of FIG.

FIG. 6 is a plan view of an IOL with four haptic elements made in accordance with the present invention.

[Figure 7]   FIG. 7 is a side view of the IOL of FIG.

[Figure 8]   FIG. 8 is an enlarged plan view of the fixed clamp of the IOL of FIG.

[Figure 9]   9 is an enlarged side view of the fixed clamp of FIG.

10 is a side cross-sectional view of the haptic element of FIG. 5 taken along line 10-10.

FIG. 11   FIG. 11 is a perspective view of the surgical tweezers.

[Fig. 12]   FIG. 12 is a perspective view of a surgical retractor.

FIG. 13 is a plan view of an IOL with two haptic elements made in accordance with the present invention.

FIG. 14 is a plan view of an IOL with three haptic elements made in accordance with the present invention.

FIG. 15 is a plan view of an IOL with four haptic elements made in accordance with the present invention.

─────────────────────────────────────────────────── ─── Continued front page    (81) Designated countries EP (AT, BE, CH, CY, DE, DK, ES, FI, FR, GB, GR, IE, I T, LU, MC, NL, PT, SE, TR), AE, A L, AM, AT, AU, AZ, BA, BB, BG, BR , BY, CA, CH, CN, CR, CU, CZ, DE, DK, DM, EE, ES, FI, GB, GD, GE, G H, GM, HR, HU, ID, IL, IN, IS, JP , KE, KG, KP, KR, KZ, LC, LK, LR, LS, LT, LU, LV, MA, MD, MG, MK, M N, MW, MX, NO, NZ, PL, PT, RO, RU , SD, SE, SG, SI, SK, SL, TJ, TM, TR, TT, TZ, UA, UG, UZ, VN, YU, Z A, ZW (72) Inventor Hagmeir, Charles Jay.             United States California 92651,               Laguna Beach, Noria Street               1089 (72) Inventor Sing, Wilson             United States California 92701,               Santa Ana, North Mirasol             913 (72) Inventor Stenger, Donald See.             United States California 92807,               Anaheim Hills, South Goal             Den Sky Lane 550 (72) Inventor Wild, Eric Tea.             United States California 91739,               Rancho Cucamonga, Travisp             Wraith 7136 F-term (reference) 4C081 AB22 CA011 CA021 CA081                       CA191 CA211 CA231 CA271                       DA01 DA12                 4C097 AA25 BB01 CC01 DD01 EE02                       EE03 EE06 EE08 EE09 EE11                       EE13 SA05

Claims (25)

[Claims] 1. An anterior chamber iris-fixing intraocular lens that is implanted into the eye through a small incision, approximately perpendicular to the visual axis of the eye, wherein: A peripheral edge, two or more haptic elements permanently bonded to the outer peripheral edge, and a locking clip in direct contact with an opening in each of the haptic elements or a lock for attachment through an opening in each haptic element An intraocular lens that includes a clamp, whereby the fixation clamp can be attached through an opening in each haptic element, or sized to implant a lens while being constructed through the opening. 2. The intraocular lens of claim 1, wherein both the haptic element and the visual portion are formed of a foldable or compressible material. 3. The intraocular lens of claim 1, wherein the haptic element and the visual portion are formed of different materials. 4. The intraocular lens according to claim 1, wherein the haptic element, the fixation clamp or the fixation clip and the optic are formed from the same or different materials. 5. The intraocular lens of claim 1, wherein the fixed clamp or clip is made from a material that is relatively stiffer than the material of the optic. 6. The intraocular lens of claim 1, wherein the fixed clamp or clip is formed of a material that is relatively stiffer than the material of the haptic element. 7. The intraocular lens according to claim 1, wherein the lens is a silicone polymer, a hydrocarbon polymer and a fluorocarbon polymer, a hydrogel, a soft acrylic polymer, a polyester, a polyamide, a polyurethane, a hydrophilic polymer. An intraocular lens formed from a material selected from the group consisting of a silicone polymer having a polymerizable monomer unit, a fluorine-containing polysiloxane elastomer, and a combination thereof. 8. The intraocular lens of claim 1, wherein the lens optic and tactile are formed from a hydrogel material and the iris fixation clamp or the iris fixation clip is formed from polymethylmethacrylate. 9. The intraocular lens of claim 1, wherein the lens is formed from a hydrogel that is 18% by weight water. 10. The lens is poly (HEMA-co-HO) except that the securing clamp or the securing clip is formed from polymethylmethacrylate.
The intraocular lens of claim 1, formed of HEXMA). 11. The intraocular lens according to claim 1, wherein the lens and a possible portion of each tactile sensation is a silicone polymer, a hydrocarbon polymer and a fluorocarbon polymer, a hydrogel, It is formed from one or more materials selected from the group consisting of soft acrylic polymers, polyesters, polyamides, polyurethanes, silicone polymers having hydrophilic monomer units, fluorine-containing polysiloxane elastomers, and combinations thereof, and at least a part of the tactile sensation. Are formed from the same or different materials selected from the group consisting of relatively strong hydrogels, polymethylmethacrylates and polyimides, and said fastening clamps are made from relatively strong hydrogels, polymethylmethacrylate polyimides, composites and metals. Is it a group An intraocular lens formed from a material selected from 12. The intraocular lens of claim 1, wherein the lens optic is formed of a material having a refractive index higher than 1.33. 13. The intraocular lens of claim 1, wherein the lens optic is formed of an acrylic material. 14. The intraocular lens of claim 1, wherein the lens optic is formed of a silicone material. 15. The intraocular lens of claim 1, wherein a glare-reducing region is formed adjacent to the outer peripheral edge of the optic. 16. The intraocular lens of claim 1, wherein the one or more haptic elements are substantially balanced with the visual axis of the eye in a plane that is substantially perpendicular to the visual axis of the eye. An intraocular lens that includes a stiffening element that has greater resistance to flexion than in a plane. 17. The intraocular lens of claim 1, wherein the haptic element is
An intraocular lens comprising a stiffening element formed from a material selected from the group consisting of polyimide, polyolefin, high density polyester, nylon and metal. 18. The intraocular lens of claim 1, wherein the fixation clamp or the fixation clip is made from a relatively strong hydrogel, polymethylmethacrylate or polyimide. 19. A method of manufacturing an intraocular lens according to claim 1, comprising: forming a first disc from one or more suitable materials; 1 from one or more suitable materials. Form one or more additional discs as needed,
Machining the lens from the first disc, and optionally one or more fixed clamps from the additional disc. 20. A method of manufacturing an intraocular lens according to claim 1, comprising the steps of: molding the lens and optionally a fixed clamp of the same or different suitable material in a removable mold. And removing the lens and optionally the fixed clamp from the mold. 21. A method of using the intraocular lens of claim 1, comprising the steps of: making an incision in the cornea of the eye; inserting the intraocular lens into the anterior chamber of the eye. And fixing the intraocular lens within the anterior chamber of the eye. 22. A method of using the intraocular lens according to claim 1, wherein: the step of making an incision in the cornea of the eye, the intraocular cavity in the anterior chamber of the eye using an inserter A method comprising inserting a lens, and fixing the intraocular lens in the anterior chamber using a fixation clamp. 23. A method of using the intraocular lens according to claim 1, wherein: the step of making an incision in the cornea of the eye, the intraocular eye in the anterior chamber of the eye using an inserter A method comprising inserting a lens, extending a fixation clamp through an opening in each haptic element, and fixing the intraocular lens in the anterior chamber with the fixation clamp. 24. A method of using the intraocular lens according to claim 1, comprising the steps of: making an incision in the cornea of the eye; using an inserter in the anterior chamber of the eye; Inserting the intraocular lens having a fixation clamp coupled to the intraocular lens, and fixing the intraocular lens in the anterior chamber with the fixation clamp. 25. A method of using the intraocular lens of claim 1, wherein: the step of making an incision in the cornea of the eye, the eye in the anterior chamber of the eye using an inserter. A method comprising inserting an inner lens and fixing the intraocular lens in the anterior chamber with a fixation clip.