IL154930A - Device for emplacing intraocular lens into the eye - Google Patents

Description

DEVICE FOR EMPLACING INTRAOCULAR LENS INTO THE EYE AND METHOD FOR USING SAID DEVICE FIELD OF THE INVENTION The present invention relates generally to the field of cataract surgery. More specifically, the present invention relates to a device for emplacing a deformable intraocular lens into the human eye. The present invention also relates to a method for emplacing a deformable intraocular lens in the human eye using said device.

BACKGROUND OF THE INVENTION Cataract surgery has made extraordinary and exciting advances over the past twenty years. During the year 2001, approximately 2.7 million Americans underwent cataract surgery. Greater than 95% of those patients now enjoy improved vision. State-of-the-art cataract surgery is a safe, effective, and comfortable procedure performed almost exclusively on an outpatient basis. Most cataract surgeries are performed using microscopic size incisions, advanced ultrasonic equipment to fragment cataracts into tiny fragments, and hard or foldable intraocular lenses (lOL's) to maintain small incision size. Cataract surgery today is the result of extraordinary technological and surgical advancements that allows millions of people to once again enjoy crisp and clear vision. A true marvel of modern medicine, cataract surgery may restore vision to levels never thought possible. During catarct surgery, the opacified lens is removed from the eye (for example, through phacoemulsification and suctioning) and an artificial lens (intraocular lens or "IOL") is inserted in its place using a pair of forceps or using a specialized injector device. The two major categories of types of artificial lenses are hard lenses and soft, deformable lenses.

Hard lenses are the more traditional choice in cataract surgery since the procedure is fairly safe and easy to carry out (also, if the lens is to be placed in the anterior capsule of the eye, then a hard lens must be used). When a hard lens is to be implanted, forceps must be employed. The disadvantage of hard lenses is that they require that a relatively large incision (6 millimeters) be made in the cornea of the eye, and that the incision be subsequently sewn up with stitches. Also, although the surgery itself has a high success rate, there can be many complications resulting from the implanting of hard artificial lenses. 2 1 54930/2 Soft lenses are steadily replacing hard lenses as the better choice for lOL's. Since soft lenses can be "folded" prior to insertion and "unfolded" once the proper location in the eye is reached, a smaller corneal incision can be made than with a hard lens. This means less trauma to the eye and an easier recovery for the patient. Three-piece soft lenses comprising a lens with two arms or "haptics" attached to either side are also available which can usually be placed into the eye in other locations in comparison to a one-piece foldable IOL.

Numerous devices are known in the art for placing a soft lens in the eye. The reason for the plethora of instruments that have been developed for this purpose is that, in spite of all its advances, cataract surgery remains a highly variable and inefficient procedure. With al l of the technology available today, even after the surgery is complete, it is impossible to know with 100% certainty if the lens was properly placed in the eye. The lens may have been improperly placed and thus not serve to correct the patient's vision to the degree which it could have. In many cases, after short period of time additional surgery will be required because the lens is doing more harm than good. Also, the procedure requires a high degree of manual dexterity to be performed efficiently and only those very experienced eye surgeons can carry out the surgery with ease. Even the most experienced surgeon cannot know if the surgery was a complete success or not.

Some of the prior art devices for injecting an artificial lens into the human eye will now be described: U.S. Patent 6,428,545 to Portney relates to an intraocular lens implanting instrument comprising a nozzle having an ocular insertion end region, at least one shield element having a protective shield region disposed in a deformed condition in the nozzle, and operating means for sequentially pushing the shield region out of the nozzle so that it expands to an undeformed state and pushing a deformed intraocular lens axial ly out of the nozzle insertion end region for expanding into its undeformed state next to the protective shield region. U.S. Patent No. 5,066,297 to Cumming relates to a surgical instrument for inserting a foldable intraocular lens into the eye, the instrument having an elongated body and a pair of slender lens gripping fingers at one end of the body which are pivotally movable away from one another to open positions. The fingers are disposed to straddle a lens in its unfolded configuration and toward one another. U.S. Patent No. 6, 174,3 15 to Chambers et al. relates to a deformable intraocular lens injecting 154930/2 apparatus including a spring-biased plunger. The apparatus may include a separate iens- injecting device having a lens-receiving cartridge, and a separate one-piece lens cartridge having a lens holding portion connected to a nozzle portion. U.S. Patent No. 6,273,894 to Dykes relates to an apparatus and method for releasably positively gripping and manipulating an implant within the eye. The apparatus preferably includes a vacuum cannula apparatus.

U.S. Patent No. 4,747,404 to Jampel describes a surgical tool for folding and inserting a folded lens into the anterior chamber of an eye through a small incision in the limbus of the eye includes an elongated tube which is longitudinally split into a U-shaped base section and a manual ly, axial ly slidable U-shaped cover section. The tube has an elongated, inner portion, which is inserted into the anterior chamber of the eye, and an outer portion. A tubular guide sleeve encircles the outer portion of the base section. A cylindrical ly-shaped plug is positioned within the base section and sleeve to provide an arcuate space between the plug and the inner wall of the sleeve. The cover section is slidably inserted within the space for guiding and positioning the cover section for overlapping or uncovering the inner end portion of the base section. Means are provided for folding and pressing a lens into the base and holding it there until the cover section is manually slid over the base to encircle the lens within the tube inner portion. When the tube inner portion is arranged within the anterior chamber, the cover section is manually moved axially to uncover the inner portion of the base section which releases the lens within the chamber.

For any lens-injecting device to be practical, it must meet the following requirements: I ) it must be simple to handle and maneuvered so that it can be easily and quickly inserted and then removed from the eye; 2) it must be able to hold the IOL wh i le the device is being inserted into the eye, without causing any damage to the lens, and 3) it must be adapted to release the IOL such that it occupies that proper position once the correct location in the eye is reached. Preferably, the device should be simple to manufacture and inexpensive.

None of the devices, known in the prior art satisfactorily meet all of the aforementioned requirements. The main challenge in the development of lens-injecting devices has been finding a way to transfer the lens into the eye without causing any 3a 154930/1 physical stress whatsoever to the lens. Since the lens is so extremely delicate, this has been a difficult task. All of the abovementioned inventions, as well as others known in the art, do not solve this problem. In all of the known inventions, the lens itself has to move within the lens-injecting device in order reach its final position in the eye. The lens thus inevitably touches or becomes compressed against at least one surface of the lens injector, resulting in damage to the lens. This situation can be likened to the birth of a baby through the vaginal canal: the journey through the canal is a potentially dangerous process for the baby, one which involves much stress and in which there is exists the possibility of systemic trauma or physical injury to the baby. However, when the baby is delivered via Caesarian section, the baby is quickly and simply taken out from the womb, and does not need to endure the difficult journey into life.

It is thus the primary object of the present invention lo provide a device for empiacing an intraocular lens into the eye in which the lens is totally free from any physical stress or friction. The lens is adapted to be held and then simply and efficiently "Emplaccd" into the eye, similar to a baby being born by a C-section. The device of the present invention eliminates the guessing-game and mistakes usually involved in cataract surgery and enables eye surgeons to perform a unified, standard surgery procedure with ease and with confidence. These and other objects of the present invention will become more readily understood and appreciated from the summary of the invention and the detailed description of the drawings that follow.

SUMMARY OF THE INVENTION The present invention relates to a device for emplacing a deformable intraocular lens into the human eye. The device comprises a cylindrical housing having a proximal end and a distal end and a lens holding section positioned at the proximal end of the cylindrical housing. The lens holding section includes a lens gripper that is extendible and retractable from the interior of the lens holding section, and the lens gripper comprises first and second shielding arms switchable between a first open state when the lens gripper is extended from the lens holding section and second closed state for shielding a deformable intraocular lens in a deformed state when the lens gripper is retracted into the lens holding section.

According to preferred embodiments of the present invention, the device further comprises means for extending and retracting said lens gripper from said lens holding section. Said means may be manual, pneumatic or electric and are adapted for being readily operated by the surgeon.

Further according to preferred embodiments of the present invention, the means comprises a rearwardly-biased plunger slidably positioned at the distal end of the cylindrical member and operably coupled to the lens gripper. The plunger may operate through any appropriate means- manual, pneumatic, electrical, etc...

Additionally, according to preferred embodiments of the present invention, the deformable intraocular lens comprises any type of soft lens, as well as - plate haptics, one-piece or three-piece lenses comprising a soft lens with a pair of haptics.

Still further according to preferred embodiments of the present invention, the device is adapted to be disposable.

It is appreciated that the device of the present invention could be used with many different sizes and types of soft lenses. 4 Moreover according to preferred embodiments of the present invention, the device further comprises a finger gripper positioned at the distal end of the cylindrical housing.

Further according to preferred embodiments of the present invention, the first and second shielding arms have semi-circular cross sections. The arms preferably face one another in a concave fashion. Preferably, the shielding arms are formed from plastic. Alternatively, they may be formed from nitinol, a metal alloy having "memory" such that when switched from a closed position to an open position, the shielding arms adopt a specific predetermined configuration.

Additionally according to preferred embodiments of the present invention, the end of the tubular member has an oval contour adapted for insertion through an incision in the cornea of the eye.

Loading the IOL into the device may be accomplished through any appropriate means known in the art.

The present invention also relates to a method for emplacing a deformable intraocular lens into the human eye, using the device as described above, comprising: (a) pressing down on a plunger, thereby causing the lens holding section to extend from the tubular member and the first and second shielding arms to open; (b) loading a deformable intraocular lens into the space between the first and second shielding arms; (c) releasing the plunger, thereby causing the lens holding section to retract into the tubular member and the first and second shielding arms to close around the intraocular lens; (d) inserting at least a portion of the tubular member of the device through an incision in the cornea of the eye until the desired location in the eye is reached; (e) pressing down on the plunger, thereby causing the lens holding section to extend (at least partially) from the tubular member and the first and second shielding arms to open so as to release the intraocular lens into place in eye; (f) releasing the plunger, thereby causing the lens holding section to retract into the tubular member and the first and second shielding arms to close; (g) withdrawing the device from the eye.

BRIEF DESCRIPTION OF THE DRAWINGS The present invention will now be described, by way of example only, with reference to the accompanying drawings, wherein: Figure 1 is an isometric view of a device for emplacing a deformable intraocular lens into the eye, according to a preferred embodiment of the present invention. The lens gripper of the device is shown in the retracted position.

Figure 2 is an isometric view of the device of Figure 1 , with the lens gripper of the device shown in the extended position.

Figure 3 is an exploded view illustrating the parts of the device of Figure 1.

Figure 4 is an isometric view of the device of Figure 1 as it is being used to emplace an intraocular lens into the eye.

DETAILED DESCRIPTION OF THE DRAWINGS It is appreciated the description provided is meant to illustrate certain preferred embodiments of the present invention. It is in no way intended to limit the scope of the invention, as set out in the claims.

Referring first to Figures 1 and 2, the device (4) of the present invention includes a cylindrical housing (5) having a proximal end (1) and a distal end (2). A lens holding section (3) protrudes from the proximal end (1) of the cylindrical housing (5). The lens holding section is substantially hollow and has an oval shaped edge (14, seen in Figure 1 ), for being easily inserted through a small (approximately 3 millimeter) incision in the cornea of the eye. A lens gripper (10) is movably positioned inside of the lens holding section (3) such that said lens gripper (10) can be extended from (as in Figure 2) and retracted into (as in Figure 1) the lens holding section. At the distal end (2) of the cylindrical housing (5) is a rearward ly-biased spring-loaded plunger (7) that is operably coupled to the lens gripper (10) such that when said plunger (7) is pushed towards the cylindrical housing (1), the lens gripper (10) extends out of the lens holding section (3). The lens gripper ( 10) is comprised of a first shielding arm (8) and a second shielding arm (9) that are semi-circular in shape and that face one another in a concave manner. The shielding arms (8,9) are designed so as to be switchable between an open position, when 6 the lens gripper (10) is extended from the lens holding section (3), and a closed position, when the lens gripper (10) is retracted into the lens holding section (3), Figure 3 illustrates the individual components of the device of the present invention. It is appreciated that the device is formed from relatively few and simple parts. Furthermore, the device of the present invention can be used with relative ease and does not require a great amount of manual dexterity in order to operate, as do devices known in the prior art. Moreover, the device of the present invention allows for the emplacing of a lens in the eye without any reason of damage that may have been caused to the lens during its passage into the eye. Thus, both time and money are saved since the lens need not be replaced in the middle of the procedure, and both the doctor and the patient are assured that the lens was properly placed and remained unscathed while it was being placed.

Reference will now be made to Figure 4 and to a method for emplacing an intraocular lens into the human eye using the device of the present invention. The surgeon first chooses the correct size and type of deformable lens. According to the illustration shown, the lens (12) has haptics (13a, 13b) on either side. The surgeon pushes inwardly onto the plunger (7) such that the lens gripper (10) extends from the lens holding section (3), thereby causing the two shielding arms (8,9) to become extended and open. The lens is then loaded into the space between the two shielding arms (8,9). Thereafter, the surgeon releases the plunger (7) to its original position such that the shielding arms (8,9) move towards one another and are retracted to the inside of the lens holding section (3). The lens is thus held securely inside of the shielding arms. Next, the tip of the device (4) is inserted through the incision in the eye and advanced to the proper location in the eye (either the bag or the sulcus). The end of the lens holding section is preferably adapted in shape for being inserted into the eye. Once properly positioned, the surgeon again presses down on the plunger (7) so as to cause the lens gripper to extend (10) from the inside of the lens holding section (3). As they are extended, the shielding arms (8,9) automatically assume an open configuration. When the arms open (8,9), the lens, due to elastic strain energy, opens and becomes emplaced in the eye. It is appreciated that no movement was caused on the part of the lens; the lens was simply placed in between the shielding arms and subsequently released when the proper location 7 in the eye was reached. In certain preferred embodiments, the device is also equipped with a safety rod (not illustrated) that is adapted to allow the surgeon to push the lens slightly when the arms open so as to ensure that the lens becomes positioned in the eye. The surgeon then gently releases the plunger (7) so that the lens gripper (10) and the shielding arms (8,9) of the lens gripper retract into the lens holding section (3) and the device is withdrawn from the eye.

It is thus appreciated that the device of the present invention allows for a lens to be emplaced into the eye without any actual movement of the lens with respect to the parts of the device. Thus, no damage whatsoever is caused to the delicate lens. There is thus provided a much more reliable and efficient procedure for placing an artificial lens in the human eye. Because there is no damage caused to the lens, it is also not necessary to repeat the procedure multiple times, as is often the case with cataract surgery. 8

Claims (11)

1. A device for emplacing a deformable intraocular lens into the human eye, comprising a cylindrical housing having a proximal end and a distal end and a lens holding section positioned at the proximal end of said cylindrical housing, said lens holding section including a lens gripper that is extendible and retractable from the interior of said lens holding section, and said lens gripper comprising first and second shielding arms switchable between a first open state when said lens gripper is extended from said lens holding section and second closed state for shielding a deformable intraocular lens in a deformed state when said lens gripper is retracted into said lens holding section.

2. A device according to claim 1, further comprising means for extending and retracting said lens gripper from said lens holding section.

3. A device according to claim 2, wherein said means comprises a rearwardly-biased plunger slidably positioned at the distal end of said cylindrical member and operably coupled to said lens gripper.

4. A device according to claim 3, wherein the rearwardly-biased plunger is operated through manual, pneumatic, or electrical means.

5. A device according to claim 1, wherein the deformable intraocular lens comprises any design or type of foldable soft lens.

6. A device according to claim 1 , adapted to be disposable.

7. A device according to claim 1, further comprising a finger gripper positioned at the distal end of the cylindrical housing.

8. A device according to claim 1, wherein the first and second shielding arms have semi-circular cross sections.

9. A device according to claim 1, wherein the first and second shielding arms are formed from plastic.

10. A device according to claim 1, wherein the first and second shielding arms are formed from nitinol.

11. A device according to claim 1, wherein the end of the tubular member has an oval contour. 9