AU2247900A - Intraocular lens insertion system - Google Patents

Description

)A

P00011 Regulation 3.2 Revised 2/98

AUSTRALIA

Patents Act, 1990

ORIGINAL

COMPLETE SPECIFICATION STANDARD PATENT TO BE COMPLETED BY THE APPLICANT r r c NAME OF APPLICANT: ACTUAL INVENTOR: ADDRESS FOR SERVICE: INVENTION TITLE: VLADIMIR FEINGOLD VLADIMIR FEINGOLD Peter Maxwell Associates Level 6 Pitt Street SYDNEY NSW 2000 INTRAOCULAR LENS INSERTION

SYSTEM

Divisional of Australian Patent Application No. 61,974/98 filed on 17 April 1998 which is a divisional of Australian Patent No. 692,425 filed on 27 March 1993 fr r DETAILS OF ASSOCIATED

APPLICATION(S):

The following statement is a full description of this invention including the best method of performing it known to me:- This invention relates to a deformable intraocular lens injection system for surgical implantation of a deformable intraocular lens into the eye.

Intraocular lenses have gained wide acceptance in the replacement of human crystalline lenses after a variety of cataract removal procedures. The human crystalline lens, is generally recognised to be a transparent structure having a thickness of about five millimetres and a diameter of about nine (9) millimetres. The lens is suspended behind the iris by zonula fibres which connect the lens to the ciliary body. A lens capsule surrounds the lens, the front portion of the capsule being commonly known as the anterior capsule and 10 the back portion commonly known as the posterior capsule.

Numerous procedures for the removal of cataracts have been .i developed in which the lens is removed from the eye and replaced by an artificial lens implant. The extraction procedure may generally be categorised as intracapsular (in which the lens is removed together with the lens capsule) and extracapsular (in which the anterior capsule is removed with the lens, and the posterior capsule is left intact).

Since Ridley implanted the first artificial lens in about 1949, the i problems associated with cataract extraction and lens implantation have o*ooo received a great deal of attention from ophthalmic surgeons. Various types of artificial lenses have been proposed, and appropriate surgical procedures have been developed which strive to reduce patient discomfort and to reduce postoperative complications. Reference is made in this connection to Pseudophakos by N. Jaffe et al.; "History of Intraocular Implants" by D.P.

Choyce (Annals of Ophthalmology, October 1973); U.S. Patent No. 4,251,887 issued to Anis on February 24, 1981; U.S. Patent No. 4.092,743 issued to Kelman on November 8, 1977; "Comparison of Flexible Posterior Chamber Implants", presented ta the American Intraocular Implant Society Symposium April 23, 1982, by Charles Berkert, and "the Simcoe Posterior Lens" (Cilco, Inc. 1980); U.S. Patent No. 4,573,998 issued to Mazzocco on March 4, 1986, U.S. Patent No. 4,702,244 issued to Mazzocco on October 27, 1987; and U.S. Patent No. 4,715,373 issued to Mazzocco et al. on December 29, 1987, which disclosures are hereby incorporated by reference.

Of particular interest is the development of surgical techniques requiring relatively small incisions in the ocular tissue for the removal of cataracts as disclosed in U.S. Patent No. 4,002,169 and U.S. Patent No. 3,996,935. A S"number of skilled artisans have disclosed intraocular lens structures comprising 10 an optical zone portion generally made of rigid materials such as glass or plastics suitable for optical use.

0: However, one of the principal disadvantages of the conventional rigid intraocular lens is that implantation of the lens requires large incisions in the ocular tissue. This type of surgical procedure leads to a relatively high complication rate, among other disadvantages. For instance, the serious .dangers associated with implantation of a rigid lens structure include increased risk of infection, retinal detachment, and laceration of the ocular tissue, particularly with respect to the pupil.

Accordingly, those skilled in the art have recognised a significant need for surgical tools for implantation of deformable intraocular lens structures which afford the clinical advantages of using relatively small incision techniques, which provide a safer and more convenient surgical procedure. In particular, those skilled in the art of deformable intraocular lenses and methods and devices for implantation, have also recognised a significant need for surgical tools which do not require widening of the wound made in the ocular tissue during or after implantation, but will deform the intraocular lens to a predetermined cross section in a stressed state and which allow the ophthalmic surgeon to inspect the lens prior to implantation without manipulation in the eye.

The present invention was derived by improving the methods in the above-identified patents, specifically the methods of U.S. Patent No.

4,573,998.

According to one aspect of the invention there is provided a deformable intraocular lens injection system comprising: an injecting device having a lens receiver and a movable plunger disposed therein, said injecting device including a passageway having at least 10 one groove for manipulating the deformable intraocular lens.

S0Preferably, the or each groove is configured for folding the deformable intraocular lens, and there is a pair of opposed groves for gripping the edges of the deformable intraocular lens.

a preferred form of the invention the passageway is inwardly tapering.

The injecting device may comprise a cartridge holding device and a lens cartridge that are separate components.

The cartridge may be defined by a lens holding portion and a nozzle i" portion.

l: In order that the invention may be more readily understood and put into practical effect, reference will now be made to the accompanying drawings in which:- Figure 1 is a perspective view of one embodiment of the intraocular lens injection device with a lens holding microcartridge positioned in the device for implantation of deformable lens structures for placement in the eye; Figure 2 is a perspective view of the surgical device depicted in Figure 1 with the plunger retracted, and with the lens holding microcartridge removed; Figure 3 is a side view of the device depicted in Figure 2, with the plunger in the extended position; Figure 4 is a side elevational view of the device shown in Figure 1; Figure 5 is a detailed longitudinal cross-sectional view of the device shown in Figure 4; Figure 6 is a detailed transverse cross-sectional view of the device, as indicated in Figure Figure 7 is a detailed end view of the device, as indicated in Figure Figure 8 is an enlarged detailed left side elevational view of the tip of the 10 plunger in the spacial orientation as shown in Figure 1; SFigure 9 is an enlarged detailed end view of the tip shown in Figure 8; Figure 10 is an enlarged detailed top planar view of the tip of the plunger; Figure 11 is an enlarged detailed right side elevational view of the tip of the plunger in the spacial orientation, as shown in Figure 4; Figure 12 is an enlarged detailed bottom view of the tip of the plunger in the spacial orientation, as shown in Figure 1; Figure 13 is a perspective view of a lens for use in the present invention; Figure 14 is a perspective view of another type of lens for use in the present invention; Figure 15 is a side view of the lens shown in Figure 13; Figure 16 is a perspective view of the lens holding microcartridge in the open position to allow a lens to be loaded therein; Figure 16A is another perspective view of the lens holding microcartridge in the open position; Figure 17 is a rear end elevational view of the lens holding microcartridge in the open position; 6 Figure 18 is a front end elevational view of the lens holding microcartridge in the open position; Figure 19 is a rear end elevational view of the lens holding microcartridge in the closed position; Figure 20 is a front end elevational view of the lens holding microcartridge in the closed position; Figure 20A is a detailed end view of the nozzle showing three slots of different length equally spaced about the circumference of the tip; Figure 20B is a detailed perspective view of the tip showing the three (3) 10 slots of different length; :Figure 20C is a detailed side view showing the bevelled tip; Figure 21 is a top planar view of the lens holding microcartridge in the open position; Figure 22 is a side elevational view of the lens holding microcartridge in the closed position; Figure 23 is a rear end elevational view of the lens holding microcartridge in the closed position; Figure 24 is a broken away side view of the device showing the lens holding microcartridge in relationship to the plunger in the retracted position.

Figure 25 is a broken away side view of the device showing the lens holding microcartridge in relationship to the plunger in a partially extended position; Figure 26 is a broken away side view of the device showing the lens holding microcartridge in relationship to the plunger in a fully extended position; Figure 27 is a perspective view showing the device positioning a deformable intraocular lens within the eye; Figure 28 is a cross-sectional view of an eye showing the positioning of the deformable intraocular lens into position in the eye by the surgical device; Figure 29 is a cross-sectional view of an eye showing the positioning of the deformable intraocular lens into a different position in the eye by the surgical device.

Figure 30 is a side elevational view of an alternative embodiment of the lens holding microcartridge provided with a bevelled tip; Figure 31 is a rear end elevational view of another alternative embodiment of the lens holding microcartridge provided with grooves in the 10 passageway to facilitate folding the cartridge in an open position; Figure 32 is a rear end elevational view of another alternative embodiment of the lens holding microcartridge provided with grooves in the passageway to facilitate folding the cartridge in a closed position; Figure 33A is a front end elevational view of the nozzle of an alternative embodiment of the lens holding microcartridge; and Figure 33B is a front end elevational view of the nozzle of a further alternative embodiment of the lens holding microcartridge.

The present invention is directed to a system for implantation of deformable intraocular lens structures for surgical placement in the eye.

The intraocular lens injection device comprises a holder having a receiver, a lens holder that can be removably inserted into the receiver of the holder, and means such as a moveable plunger disposed within the holder to force and manipulate the lens from the lens holder into the eye.

Preferably, the lens holder is defined by a lens holding microcartridge for receiving the lens structure. Further, the microcartridge is preferably a structure configured to be opened and closed. The preferred embodiment of the microcartridge receives a lens having prescribed memory characteristics 8 when in the open position, and performs the function of folding or deforming the lens structure into a condensed configuration when being closed.

Alternatively, the microcartridge can be a structure having a passageway defined by a continuous walled annulus, and a lens could be inserted into the passageway from the end of microcartridge by comprising, rolling, folding, or combination of these techniques prior to insertion into the microcartridge.

Once a lens is positioned into the microcartridge, the microcartridge is positioned into a plunger device. The assembled device maintains the lens in its condensed configuration during insertion into the eye yet permits the 10 deformed lens to return to its original configuration, size and fixed focal length once implanted in the eye, thereby provided a safe, convenient, and comfortable surgical procedure.

A preferred embodiment of a deformable intraocular lens implantation i• device 10 is shown in Figures 1, 2 and 3. The implantation device comprises a microcartridge 12 disposed within a holder 13 comprising a holder body 14 with a receiver 15, and a moveable plunger 16. In Figure 1, the receiver 15 is defined by an opening 17 through the wall of the holder body 14 of the size and shape shown in Figures 1 and 2. The opening 17 is defined by parallel edges "iI* 17a, 17a, which are sufficiently spaced apart to allow the microcartridges 12 to be loaded into the receiver 15 of the holder 13, tapered edges 17b, clamping edges 17c, and stop edge 17d. In Figure 1, the microcartridge 12 is positioned in the receiver 15 between the clamping edges 17c with the plunger extending through the microcartridge 12 in a position, for example, after a lens implantation procedure.

In Figure 2, the lens holding microcartridge 12 is shown removed from the holder 13 with the plunger 16 in a retracted position for allowing the microcartridge 12 containing a loaded lens and its haptic to be inserted within the holder 13. In Figure 3, the holder 13 is shown with the plunger 16 in the extended position without the microcartridge 12 for purposes of illustration of the components.

The plunger 16 is fitted with a threaded end cap 18 at one end, and fitted with a tip 20 at an opposite end. The threaded end cap 18 is provided with a plurality of grooves 22 to allow a person to tightly grip the cap 18 with his or her finger tips. The threaded end cap 18 is received within a threaded sleeve 24 of the insert holder 14. The threaded end cap 18 can be a separate component attached to the insert holder 13, or integral therewith, as shown in 10 the construction of Figure 0 The plunger 16 is installed within the holder 13 in a manner to allow the :plunger to be reciprocated therein. In the illustrated embodiment, the plunger 16 is supported for sliding movement within the holder 13 by guide 26, as shown in Figures 5 and 6. The outer dimension of the guide 26 is approximately the same size as the inner dimensions of the holder 13 to allow the guide to be inserted within the insert holder. During construction, the guide 26 is inserted within the holder 13, and locked into position by pin 28 inserted ~into a predrilled hole in both the wall of the holder 13 and guide 26.

The cross-sectional shape of the plunger 16 as well as the shape of the inner surface of the guide 26 are approximately a half-circle, as shown in Figure 6. This arrangement prevents the plunger 16 from rotating within the holder 13 to maintain the orientation of the tip 20 relative to the holder 13 during operation.

The threaded end cap 18 is connected to the plunger 16 in a manner to allow the threaded end cap 18 to be rotated relative to the plunger 16. For example, the left end of the plunger 16 (Figure 5) is provided with a threaded extension 30, which is secured to the threaded end cap 18 by a nut 32.

Specifically, the threaded end cap 18 is manufactured with external threads 34 and a longitudinal center bore 36 that ends on the right side of the threaded end cap 18 leaving a wall 38.

The wall 38 is provided with a hole slightly larger than the outer diameter of the threaded extension 34 to allow the threaded end cap 18 to freely rotate on the plunger 16 while being secured to the end of the plunger 16. During construction, the nut 32 is inserted through the center bore 36 and threaded onto the extension 30 to secure the threaded end cap 18 to the plunger 16. A curved cap 40 is press fitted into the end of the center bore 36 to seal the 10 center bore 36 to prevent debris from entering therein during use.

The details of the tip arrangement are shown in Figures 7 to 12. The plunger 16 is manufactured with an extension 42 supporting tip 20. The tip structure provides means for inserting the deformable intraocular lens into the °.*o•eye and manipulating the lens within the eye after the insertion step. For example, the tip 20 is faceted in the manner shown in the figures. Specifically, the left side of the tip 20 shown in Figure 8 is provided with a flat surface facet 44, conical surface 46, and cylindrical surface 48. The right side shown in Figure 11 is provided with a concave surface facet The end face of the tip 20 is designed to push the lens into position once inserted into the eye. For example, the end face is defined by a concave cylindrical surface 52 shown in Figure 8.

Suitable deformable intraocular lens for use in the present invention are shown in Figures 13-15. The deformable intraocular lens 54 shown in Figures 13 and 15 includes a lens body 56 with attachment means defined by a pair of haptics 58 each having one end anchored in the lens portion 56 and a free end for attachment to the eye tissue. The deformable intraocular lens 60 shown in 11 Figure 14 includes a lens body 62 and attachment means defined by a pair of lateral lobes 64 of the lens portion 62.

The details of the preferred lens holding microcartridge 12 are shown in Figures 16 -20. The microcartridge 12 comprises a split tubular member 66 extending to a continuous tubular member 67 and an implantation nozzle 68.

When the microcartridge is in a closed position, a continuous circular or oval passageway of the same diameter extends through the split tubular member 66 through the continuous tubular member 67 and through the implantation nozzle *oo68. The microcartridge is preferably made of injection moulded plastic such a 10 polypropylene. The split tubular member 66 is defined by a fixed portion and a moveable portion 72. The fixed portion 70 is fixed relative to the implantation nozzle 68, and is defined by a tubular portion 74 and extension 72. The moveable portion 72 is moveable relative to the fixed portion 70 for opening and closing the split tubular member 66. The moveable portion 72 is defined by a tubular portion 78 and extension 80. A hinge 82 is provided S"between the fixed portion 70 and moveable portion 72. The hinge 82 is defined by reducing the thickness of the walls of the tubular portion 74 and at the hinge 82, as shown in Figures 17, 18 and 19. The hinge 82 runs the length of the split tubular member 66 to allow the extension 76 and 7 8 to be split apart, or brought together to open and close, respectively, the split tubular member 66.

The tubular portion 78 of the moveable portion 72 is provided with a sealing edge 84, which is exposed when the lens holding microcartridge 12 is opened, as shown in Figure 16A, and seals with a similar sealing edge 86 (See Figures 17 and 21) of the continuous tubular member 67 when the lens holding microcartridge is closed. As can be seen in Figures 21 to 26, the tip 69 of the nozzle 68 is inwardly tapered as is the passageway through the tip 69.

The end of the tip 69 of the nozzle 68 is provided with three(3) equally spaced slots 87a, 87b and 87c of different length provided about the circumference thereof, as shown in Figures 20A and 20B. The slot 87a positioned at the top of the tip 69 is the shortest, slot 87c on the right side of the tip 69 is the longest, and slot 87b on the left side is of medium length. The slots 87a, 87b, 87c cause the lens 54 to rotate as it exits the tip 69.

Other embodiments of the microcartridge 12 are shown in Figures 30 33.

The microcartridge shown in Figure 30 is provided with a bevelled tip 94 10 to facilitate entry of the tip through the incision in the eye during implantation.

The bevelled tip 94 can be set at approximately forty-five (45) degrees relative to the passageway through the microcartridge 12.

The embodiment of the microcartridge shown in Figures 31 and 32 is provided with a set of grooves 96 provided inside the passageway therethrough. The grooves accommodate the edges of the lens being loaded into the microcartridge to facilitate bending of the lens. Specifically, the edges l of the lens are placed in the grooves 96 to prevent relative slippage of the edges with the inner surface of the passageway through the microcartridge when the microcartridge is being folded into the closed position. As is evident from Figures 31 and 32, the grooves 96 are formed in the fixed portion 70' and the moveable portion 72 of the split tubular member 66 but not in the nozzle portion 68'.

The embodiments of the microcartridge shown in Figures 33A and 33B each have a nozzle 68' having an oval cross-section with slots 87' differently position as shown, respectively, again to facilitate entry through an incision in the eye. Alternatively, the cross-section can be two half circles set apart and connected together rather than oval.

The various features of the microcartridges shown in Figures 16-21 and 30-33 can be used in various combinations to achieve an optimum design for a particular application. However, all of these features are typically considered improvements of the basic combination.

The components of the device 10, except for the microcartridge 12, are preferably fabricated from autoclavable material such as stainless steel or from a disposable rigid plastic such as medical grade ABS or the like.

The surgical procedure begins by catching the lens with a surgically compatible lubricant, and loading the lessen into the microcartridge. For 10 example, as shown in Figure 21, a lens 54 having a lens body 56, a leading haptic 58a is loaded into the microcartridge 12 while a trailing haptic 58b remains trailing outside the microcartridge in the manner shown. Specifically, the lens 54 is loaded downwardly into the opened microcartridge 12 until it sits on the inner surfaces of the tubular portions 74 and 78, for example, with a pair of tweezers. The outer circumferential surface of the lens 54 are held by edges 88 and 90 of the tubal portions 74 and 78, respectively. The rear edge of the lens 54 is placed approximately at the rear edge of the microcartridge 12. The lens 54 is further manipulated to situate the haptics 58a and 58b in the manner i shown. Specifically haptic 54a is positioned in a leading position and the other haptic 54b is positioned in a trailing position outside with respect to the direction of implantation, as indicated by the arrow.

Subsequently, the split tubular member 66 of the microcartridge 12 is closed about the lens 54 by forcing the extensions 76 and 80 together with his or her finger tips. The inner surfaces of the tubular positions 74 and 78 bend and fold the lens 54 when the extensions 76 and 80 are forced together, as shown in Figures 22 and 23. Due to the resilient nature of the deformable intraocular lens 54, the lens 54 conform to the curved inner curve of the tubular portions 74 and 78 without damage thereto, as shown in Figure 23.

The microcartridge 12 containing the loaded lens 54 is inserted between the edges 17a, 17a of the opening 17 into the receiver 15 of the holder 13. As the microcartridge 12 is moved forward, the extensions 76 and 80 move past the tapered edges 17b and come to a stop position between the clamping edges 17c when front portions of the extensions 76 and 80 contact with the stop edge 17d. The clamping edges 17c prevent rotation of the microcartridge inside the holder 13.

i' 10 The user pushes the threaded end cap 18 forward while securing the holder body 14 from movement, forcing the plunger 16 forward within the holder. As the plunger 16 is moved forward, the tip 20 enters into the rear of the microcartridge 12 and misses the trailing haptic 58B until the tip makes contact with the loaded lens 54, as shown in Figure 24. As the plunger 16 is moved forward in this manner, then lens 54 previously lubricated, is forced into the implantation nozzle 68 of the microcartridge 12, as shown in Figure Once the lens 54 enters the implantation nozzle 68, the threads of the end cap 18 contact with the threads of the sleeve 24 stopping further movement of the plunger 14 forward in this manner. The end cap 18 is slightly rotated to engage the threads of the end cap 18 with the threads of the sleeve 24. At this point, the surgical device is ready for the implantation step. The nozzle is inserted through the incision in the eye, and the end cap 18 is rotated to continue the forward movement the plunger 16 by continued rotation of the end cap 18 relative to the holder body 14 to expel the lens from the nozzle into the interior of the eye, as shown in Figure 26. This manner of screw advancement for moving the plunger 16 forward provides for precise control and accuracy concerning forcing the lens 54 through the remaining portion of the tip 68 into the eye during the implantation procedure. The deformed lens after exiting the nozzle 16 returns to its original configuration, full size and fixed focal length.

After the lens is inserted into the eye, the end cap 18 is further rotated to fully expose the tip 20 of the plunger 16, as shown in Figures 28 and 29, to allow the lens to be pushed forward, side manipulated to rotate the lens, and pushed down to properly position the lens within the eye without the aid of other surgical instruments.

The configuration of the tip 20 is important during the implantation process. The faceted tip 20 provides a clearance between the tip 20 and the inner surface of the passageway through the microcartridge 12 to accommodate the trailing haptic 58b during movement of the lens within the microcartridge 12, as shown in Figures 25 and 26. Specifically, there exists a sufficient clearance between the flat surface facet 44 and the inner wall of the passageway through the microcartridge 12. During the implantation process, the trialing haptic floats around in the space between the extension 42 of the O*99 tip 20 and the inner wall of the passageway, as shown in Figure 25. This prevents any chance of damage to the trailing haptic, for example, by being caught between the tip 20 and the lens 54 during the implantation process.

The leading haptic moves through the passageway unimpeded during the implantation process preventing any damage thereto.

Claims (7)

1. A deformable intraocular lens injection system comprising: an injecting device having a lens receiver and a moveable plunger disposed therein, said injecting device including a passageway having at least one groove for manipulating the deformable intraocular lens.

2. A system according to claim 1 wherein said at least one groove is configured for folding the deformable intraocular lens.

A system according to claim 2 wherein said at least one groove is defined by a pair of opposed grooves for gripping edges of the deformable intraocular lens.

4. A system according to claim 1 wherein said passageway is inwardly S. tapering.

5. A system according to claim 1 wherein said injecting device comprises a cartridge holding device and a lens cartridge.

6. A system according to claim 5 wherein said cartridge holding device and said lens cartridge are separate components.

7. A system according to claim 6 wherein said cartridge is defined by a lens holding portion and a nozzle portion. Dated this 1 4th day of March 2000 VLADIMIR FEINGOLD Patent Attorneys for the Applicant PETER MAXWELL ASSOCIATES see* **so