US20040127911A1 - Device for inserting a flexible intraocular lens - Google Patents

Abstract

A device for inserting a flexible intraocular lens into an eye including a tubular member and a plunger. The tubular member includes a staging area, a lumen, and an open distal end. The staging area supports the lens in an unstressed state prior to engagement by the plunger. In the unstressed state, the optic of the lens is suspended in a pocket to avoid any substantial contact with interior portions of the tubular member. The plunger includes a slot in its distal tip for receiving and gripping the lens. With this construction, the lens can be inserted into the eye in one continuous motion. Further, the plunger holds the lens when the lens is moved out of the tubular member.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS
• This application is a continuation of U.S. Ser. No. 09/977,961 filed Oct. 17, 2001, which is a divisional of U.S. Ser. No. 08/615,185 filed Jun. 25, 1996, which is a 371 of International Appln. No. PCT/US95/09973 filed Aug. 7, 1995, which is a CIP of U.S. Ser. No. 08/286,557 filed Aug. 5, 1994.[0001]
FIELD OF THE INVENTION
• The present invention pertains to a device for inserting a flexible intraocular lens (IOL) into the eye of a patient.[0002]
BACKGROUND OF THE INVENTION
• The natural crystalline lens of the eye plays a primary role in focusing light onto the retina for proper vision. However, the lens can become damaged due to injury or become cloudy because of the aging process or disease and form a cataract. To restore vision to the eye, the natural lens must be surgically removed and an artificial lens implanted as a replacement.[0003]
• Many surgical procedures have been developed for removing the natural lens. As an example, phacoemulsification is one such process which has gained wide popularity. According to this procedure, a slender implement is inserted through an incision made in the eye and into the natural lens. The implement produces ultrasonic vibrations and emulsifies the lens. The emulsified portions of the lens are then aspirated out of the eye through a passage provided in the implement. As opposed to other procedures, this lens extraction method requires the surgeon to make only a narrow incision in the eye. In general, the use of a small incision can lessen the trauma and complications experienced during the surgery and postoperatively.[0004]
• A flexible IOL comprises a central optic portion which focuses light on the retina and at least one outwardly extending haptic. Haptics can have a variety of different configurations, but most commonly are either a plate-like extension of the optic or loop shaped. In any event, the haptics extend outwardly to position the optic of the lens in alignment with the pupil. Flexible IOLs are particularly suited for insertion in the eye following a phacoemulsification lens extraction procedure. Whereas placement of a hard, non-foldable IOL would require widening of the small phacoemulsification incision, a flexible IOL can be compressed or folded for passage through the narrow incision in the eye. Once the lens is passed through the incision and released into the eye, it will expand to its original shape and size.[0005]
• A number of different devices have been developed to implant a flexible IOL into an eye. See, for example, U.S. Pat. No. 4,573,998 to Mazzocco, U.S. Pat. No. 4,681,102 to Bartell, U.S. Pat. No. 4,919,130 to Stoy et al., and U.S. Pat. No. 5,275,604 to Rheinish et al. In general, these devices function to pass a compressed lens through the narrow incision made in the eye. These devices, however, require undue manipulation of the lens, include a multiplicity of parts, and/or fail to provide ample control of the lens as it enters the eye.[0006]
SUMMARY OF THE INVENTION
• The present invention is a device which enables flexible IOLs to be easily folded, compressed and inserted through an incision in the eye. In general, the insertion device comprises a tubular member for receiving the lens and a plunger for pushing the lens through the tubular member and into the eye. As the lens is pushed through the passage, it is compressed into a smaller configuration. The construction of the present invention ensures an easy, sure and consistent compression of the lens.[0007]
• According to one aspect of the invention, the tubular member includes a staging area for holding the lens in an unstressed condition. The lens is preferably held in a suspended position by its haptics so that the optic remains substantially free of contact with the interior of the tubular member. In this manner, the device can be used as the lens package, and the device can be shipped and stored with the lens already in place and ready for use. As a result, unnecessary manipulation of the lens is avoided. According to another aspect of the invention, the plunger tip is provided with a structure which holds the lens to the plunger when the lens is pushed out of the tubular member. The distal tip of the plunger is preferably bifurcated to define a slot for partially receiving and gripping the lens. With this construction, the plunger is able to hold the lens when the lens exits the tubular member and expands into the eye. Holding the lens in this manner eases placement of the lens in the eye and alleviates the risks associated with uncontrolled unfolding of the lens or uncontrolled expulsion of the lens from the inserter into the eye.[0008]
BRIEF DESCRIPTION OF THE DRAWINGS
• FIG. 1 is a perspective view of an insertion device in accordance with a preferred embodiment of the present invention.[0009]
• FIG. 2 is a side elevational view of the plunger of the insertion device.[0010]
• FIG. 3 is a top plan view of the plunger.[0011]
• FIG. 4 is a cross-sectional view taken along line[0012]4-4 in FIG. 3.
• FIG. 5 is a partial top plan view of the tubular unit of the insertion device, including the staging area, with the cover removed and overturned, and the cannula omitted.[0013]
• FIG. 6 is a cross-sectional view taken along line[0014]6-6 in FIG. 5 with the cover placed onto the shelf segment.
• FIG. 7 is a cross-sectional view taken along line[0015]7-7 in FIG. 5 with the cover placed onto the shelf segment.
• FIG. 8 is a cross-sectional view taken along line[0016]8-8 in FIG. 5 with the cover placed onto the shelf segment.
• FIG. 9 is a cross-sectional view taken along line[0017]9-9 in FIG. 5 with the cover placed onto the shelf segment.
• FIG. 10 is a cross-sectional view taken along line[0018]10-10 in FIG. 5 with the cover placed onto the shelf segment.
• FIG. 11 is a cross-sectional view taken along line[0019]11-11 in FIG. 5 with the cover placed onto the shelf segment.
• FIG. 12 is a cross-sectional view taken along line[0020]12-12 in FIG. 13.
• FIG. 13 is a partial cross-sectional view taken along line[0021]13-13 in FIG. 1, with an IOL in the staging area.
• FIG. 14 is an exploded view of FIG. 13.[0022]
• FIG. 15 is a partial top plan view of the tubular unit of the insertion device with an IOL in the staging area and with the cover and cannula omitted.[0023]
• FIG. 16 is a side elevational view of the distal tip of the plunger.[0024]
• FIG. 17 is a front view of the distal end of the plunger.[0025]
• FIG. 18 is a top plan view of the distal end of the plunger.[0026]
• FIGS.[0027]19-23 are each schematic, partial cross-sectional views taken along line19-19 in FIG. 1, illustrating the movement of the plunger during insertion of the IOL into an eye.
• FIG. 24 is an enlarged top plan view of the distal tip of the plunger holding an IOL.[0028]
• FIG. 25 is a front end view of the insertion device with the plunger extended to the distal end of the cannula.[0029]
• FIG. 26 is a cross-sectional view of an eye illustrating the insertion and placement of an IOL.[0030]
• FIG. 27 is a perspective view of an alternative construction of the distal end of the cannula.[0031]
• FIG. 28 is a perspective view of a second alternative construction of the distal end of the cannula.[0032]
• FIG. 29 is a perspective view of a third alternative construction of the distal end of the cannula.[0033]
• FIG. 30 is a side elevational view of a fourth alternative construction of the distal end. of the cannula.[0034]
• FIG. 31 is a front elevational view of the fourth alternative construction of the distal end of the cannula.[0035]
• FIG. 32 is a perspective view of an alternative embodiment of the cannula.[0036]
• FIG. 33 is a perspective view of another alternative embodiment of the cannula.[0037]
• FIG. 34 is a partial, longitudinal cross-sectional view of an alternative embodiment of the tubular unit with the cover open and the cannula removed.[0038]
• FIG. 35 is a cross-sectional view taken along line[0039]35-35 in FIG. 34 without the cover.
• FIG. 36 is a plan view of the inside of the cover of the alternative tubular unit embodiment of FIG. 34.[0040]
• FIG. 37 is a plan view of the inside of the shelf segment of the alternative tubular unit embodiment of FIG. 34.[0041]
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
• The present invention pertains to a device[0042]10 (FIG. 1) for inserting aflexible IOL12 into aneye14 of a patient (FIG. 26). The device comprises an outer tubular unit16 and aninner plunger18. In one embodiment, tubular unit16 is formed by abase member20, acover21 and acannula22 which are coupled together (FIGS. 1, 13 and14). The components ofdevice10 may be composed of a plastic or metal material. For example, the components can be formed of polycarbonate or polypropylene. Theplunger18 andcannula22 are preferably made of polypropylene. Nevertheless, a wide array of materials could be used.
• [0043]Base member20 is an elongate tubular member defining aninner passage24 which is provided with a relatively large opening atproximal end26 and an opening27 of reduced size near, but spaced from, distal end28 (FIGS. 1, 5,13 and14). A forwardly extendingshelf segment29 projects beyond opening27 (FIGS. 5, 13 and14).Base member20 preferably has a generally oval cross-sectional configuration, although other shapes could be used.
• The[0044]inner passage24 ofbase member20 is adapted to movably receive thereinplunger18. Alongitudinal groove34 is preferentially positioned along one of theside walls32 defining inner passage24 (FIG. 13).Groove34 cooperates with an extendingflange35 projecting laterally fromplunger18 to ensure that the plunger is properly oriented when fed intobase member20. Nevertheless, the groove construction could be replaced with a different structure for ensuring proper placement, such as forming at least a portion ofinner passage24 andplunger18 with a D-shaped configuration. Neardistal end28,base member20 forms a narrowedneck39.Neck39 defines distal opening27 through which a portion of the plunger is passed to engagelens12. Convergingguideways41 are positioned along opposite interior sides ofpassage24 leading up to neck39 (FIGS. 5, 13 and14).Guideways41 function to ease the passage of the plunger throughneck39 and over theshelf segment29 for engagement withlens12.
• [0045]Shelf segment29 is formed as an extension of roughly one half of thetubular base member20.Shelf segment29 cooperates withcover21 to define astaging area compartment45 for holding lens12 (FIGS.5-11 and13-14).Lens12 preferably has a central optic and a pair of adjacent web or plate haptics49a,49b(FIGS. 14 and 24). Nevertheless, other lens constructions, such as a lens with loop haptics, could also be used. The interior side ofshelf segment29 is formed in part by a pair of ledges51a,51badjacent neck39, a pair of recessedcentral flats52a,52b, and a pair oframps53a,53bspaced forwardly offlats52a,52b(FIGS.5-11 and13-14). Ledges51a,51band ramps53a,53bare each formed withtop surfaces54a,54b,55a,55bto engage and support thehaptics49a,49boflens12 in an initial unstressed position.Ramps53a,53bfurther include slopedsurfaces59a,59binclined toflats52a,52b.Flats52a,52bare recessed relative totop surfaces54a,54b,55a,55bto define apocket60 into which is receivedoptic48.
• [0046]Cover21 lies againstshelf segment29 to formstaging area compartment45 and encloselens12 in its initial unstressed position (FIG. 13).Cover21 includes on its interior side recessedsections61a,61b, the central portions of which lie opposed to the proximal half offlats52a,52b. A pair ofadjacent plateau segments63a,63blie opposed to ledges51a,51bdefine agap65 adapted to matingly receive and hold the proximal haptic49a. Haptic49ais loosely received ingap65 so that it can be easily pushed out ofstaging area45 during the insertion process. Ledges51a,51b,plateau segments63a,63b, and ramps53a,53bcollectively supportlens12 by haptics49a,49b. In this initial position, optic48 is held in suspension inpocket60 so that the optic avoids contact with the interior walls of thestaging area compartment45.
• The[0047]lens12 can be installed incompartment45 at a manufacturing plant and shipped to the user indevice10 with or withoutcannula22 assembled in place. In this manner,device10 can conveniently serve also as a lens package. Sincelens12 is supported in a generally suspended and unstressed state, the lens can be stored for a substantial length of time, perhaps as long as10 years. Although the cover could be fixed tobase member20, it is designed for removal to enable inspection of the lens prior to its implantation in the eye. As shown in FIG. 14, cover21 can be separable frombase member20, and secured in place by a snap fit, tape or other securing means. Nevertheless, the cover may be hinged tocannula22,shelf segment29, orneck39.
• [0048]Cover21 includesprojections67a,67bwhich mate withdepressions68a,68bformed inshelf segment29. In addition,shelf segment29 includes proximal outer walls70a,70band distalouter walls72a,72b. Proximal walls70a,70babut the outer portions of recessedsections61a,61b.Distal walls72a,72blikewise abutwalls73a,73bofcover21.Distal walls72a,72bare preferably recessed relative to proximal walls70a,70bto enhance the mating fit ofcover21. During shipping of the device, the cover may be held closed bycannula22, tape and/or other means to avoid inadvertent release of the lens.
• [0049]Troughs75a,75bare formed inshelf segment29 by extending the innerside wall surface78 ofcompartment45 downwardly between the outer distal sides offlats52a,52banddistal walls72a,72b.Troughs75a,75bare provided to receive the opposite sides oflens12 as they are folded or curled along innerside wall surface78. In the preferred embodiment, the troughs are deeper thanflats52a,52b.
• [0050]Cover21 further includes a central, generallyplanar surface88 inclined to extend away fromshelf segment29. A conically shapedportion91 generally surroundinginclined surface88 lies opposed toramps53a,53b. Thesesurfaces88,91 in cooperation withramps53a,53binitiate the desired folding of the lens to its compressed state.
• [0051]Cannula22 is an elongate tubular member with an openproximal end93 and an opposite open distal end95 (FIGS. 1 and 12-14).Cannula22 is preferably subdivided into three graduated sections97-99. Theproximal section97 has a generally rectangular configuration and defines aninner cavity101 sized to matingly receive the assembledshelf segment29 andcover21.Section97 extends fromdistal end28 toneck39 ofbase member20 and functions to holdcover21 againstshelf segment29. Anaxial channel102 is defined along one wall ofcavity101 to matingly receiveridge103 extending up fromcover21. Ahole104 defined at theproximal end93 ofcannula22 cooperates with a biased lock106 onbase member20 to secure the cannula in place.
• The[0052]medial section98 ofcannula22 is significantly smaller thanproximal section97 so that arim110 is defined therebetween.Rim110 acts as a shoulder in abutment with the aligned distal ends28,111 ofbase member20 andcover21. The inner wall ofmedial section98 converges to define a funnel-shapedpassage112. Thefunnel portion112 preferably has an oval cross-section, although other shapes could be used. This funnel section causes the lens to become substantially curled and compressed for entry into the eye.
• The final,[0053]distal section99 ofcannula22 is a long, narrow tube which defines aninner lumen114.Distal section99 is to be inserted through the narrow incision made in the eye. As withmedial section98,distal section99 andlumen114 preferably have an oval cross-sectional shape. Of course, other shapes could be utilized if desired. To facilitate manufacturing and further compression oflens12,lumen114 is formed to taper slightly as it extends forward.Distal end95 ofcannula22 is beveled to ease the insertion of the cannula into the incision and to assist in facilitating a gradual expansion of the lens as it exits fromlumen114.
• The distal section of the cannula may be provided with a wide variety of cross-section configurations. As examples only, the cannula may be shaped with a clover-type tip[0054]22A, a collapsible bag type tip22B, or a wave-type tip22C (FIGS.27-29). These configured tips enhance the strength of the tip and thus permit a narrower construction to be used. The cannula tip may also be formed with a collet-like construction22D. In this embodiment, the tip includes fourseparable leaves23 which are expanded as the lens is pushed into the eye. The leaves23 are biased to naturally close after the lens is placed into the eye and the plunger retracted.
• In the preferred embodiment, cover[0055]221 is hinged tobase member220 of tubular unit216 (FIGS.34-37). The inside configuration of cover221 is essentially the same as the inside configuration ofcover21, except thatprojections267 are interconnected withplateau segments263 bysegments264. Similarly, the inside configuration ofshelf segment229 is essentially the same as the inside configuration ofshelf segment29. As can be seen in FIG. 37,shelf segment229 includes a corresponding interconnection ofdepressions268 withledges251. Also, the central channel224 ofshelf segment229, which accommodates passage of the plunger, is enlarged across its middle section. These modifications do not affect the operation of compressing and inserting the lens into an eye.
• Also, as an optional feature, a[0056]hole246 may be provided throughshelf segment229. The hole can be used to insert a viscoelastic material in embodiments wherein the cover is fixed to the shelf segment or otherwise not opened by the surgeon.
• Cover[0057]221 further includes a pair of rearwardly extendingarms265, which are provided withknobs266 on their free ends.Arms265 are provided to pivotally connect the cover to theneck portion239. Specifically,neck portion239 includes a pair ofsockets242.Sockets242 are formed to include substantially square-shaped openings243 (although other shapes could also be used) for receivingknobs266, andchannel portions244 for receivingarms265 when cover221 is moved to its closed position (not shown).Recesses245 are formed on the outside walls of openings243 (FIG. 35) to receive the outward projection ofknobs266. Receipt ofknobs266 inrecesses245 functions to retain the cover221 tobase member220.
• In an alternative embodiment,[0058]cannula160 includes acover162 hinged for movement between an open position and a closed position (FIG. 32).Cannula160 has essentially the same construction ascannula22, except for the incorporation ofcover162 inproximal section164. Cover162 has substantially the same construction ascover21, including the same internal configuration for supporting and compressing the lens.
• [0059]Proximal section164 ofcannula160 comprises abase166 and acover162. The base includes abottom wall168 and a pair ofside walls170 which extend upward only as high asshelf segment29. The internal surfaces ofbottom wall168 andside walls170 are shaped to matingly receive the external surface ofshelf segment29. A pair ofupstanding flanges172 are provided atproximal end174 ofbase166 to engageneck39 and provide ample support for the cannula. Ahole176 is provided to cooperate with a protrusion (not shown) onshelf segment29 in locking the cannula to thebase member20.
• [0060]Cover162 is movably connected to base166 by aliving hinge178, although other hinge constructions could also be used. The cover is pivotally movable to an open position to permit inspection of the lens, and to a closed position for inserting the lens into a patient's eye. The lower edges ofside walls180 of the cover are formed to snap into a locking engagement withbase166 by any conventional construction (not shown); nevertheless, other fastening arrangements could be used. The internal configuration ofcover162 aligns with the internal configuration ofshelf segment29 in the same way ascover21. Cover162 further includes aproximal tab182 which projects betweenflanges172 to engage locking protrusion106 inhole184.
• As an alternative construction,[0061]side walls170aof cannula160aextend the entire depth ofproximal section164a, and cover162ais provided with a flattened construction (FIG. 33). The internal side of cover162ahas the same configuration and relative positioning toshelf segment29 as does the above-describedcover21. Theedges180aof cover162aare preferably constructed to snap into locking engagement withedges181aofside walls170a. Nonetheless, other fastening arrangements could be used.
• Preferably,[0062]cannula162,162ais composed of a polypropylene or other thermoplastic material. A disposable cover (not shown), can be used to ship and store the IOL indevice10. The disposable cover preferably has the same general size and shape ascover162,162ato enable it to snap into engagement withbase166,166a. The disposable cover can have a wide variety of internal constructions so long as the IOL is adequately supported (as described above with respect to the other covers) and protected.
• [0063]Plunger18 is an elongate member which is adapted to move through theinner passage115 defined by tubular unit16 (FIGS. 1 and 13). The plunger comprises amain body116 preferably shaped with a cross-shaped cross-section (FIGS.2-3). As discussed above, oneflange35 of the body is received intogroove34 to ensure proper placement of the plunger. Aflat thumb pad119 is provided on the proximal end ofbody116 for manual operation of the device. Other constructions, however, may be provided to effect advancement ofplunger18 through tubular unit16. The forward end ofbody116 includes a pair of spaced apart O-rings120a,120b. The O-rings provide a level of resistance to enable a more controlled manual operation of the plunger. The O-rings further help to prevent the plunger from inadvertent movement when the surgeon manipulatesdevice10 during the surgical procedure. Other constructions, such as friction fit flanges, could be used in place of the O-ring.
• A[0064]slender rod122 projects forwardly beyond themain body116 ofplunger18. The rod is intended to pass throughstaging area45,funnel112 andlumen114. In order to provide sufficient clearance forrod122,shelf segment29 defines a channel124 and cover21 includes a relief125 (FIGS.5-11 and13-14).Relief125 only extends partway acrosscover21 becausesurface88 diverges away from the interior side ofshelf segment29 and thus provides sufficient clearance forrod122. Whilerod122 could have a wide range of shapes, it preferably has a circular or a slight ellipsoid shape adapted to pass through thedistal end95 of cannula22 (FIG. 25).
• The[0065]distal tip128 ofrod122 is preferably bifurcated to define a pair ofprongs131a,131bseparated by a slot132 (FIGS.2-3,16-18,24 and25). The slot is shaped to receive and hold proximal haptic49aandoptic48 oflens12. The ends135a,135bofprongs131a,131bare chamfered to form a pair ofwalls137a,137bwhich collectively form a generally V-shaped configuration. Depending on the sturdiness of the proximal haptic,walls137a,137bmay or may not engage the proximal end of the optic48.Prongs131a,131bare preferably identical to one another. Nevertheless, oneprong131acan be made narrower than theother prong131bto allow extra space for thelens12 to curl and compress during its passage throughlumen114 and into the patient's eye. Under ordinary circumstances, however, the extra space is not needed.
• The distal tip of[0066]plunger18 may alternatively be formed with other structural configurations which would hold the lens when the lens is pushed out of the cannula. For example, when implanting an IOL with loop-shaped haptics, the plunger may be formed with a closed vertical slot (not shown) along the top ofrod122 in lieu of the openhorizontal slot132. In this arrangement, the lens would be positioned in stagingarea45 with the haptics extending from points along the sides of the tubular unit. The haptic, which curls rearwardly would be inserted into the vertical slot when the lens is mounted in the staging area. To avoid inadvertent release of the haptic during shipping and storage, the plunger could be secured in a fixed position through the use of a latch, tape, or other securing means. In any event, the plunger would engage the optic portion of the lens with its distal tip, formed for example with only inclined surfaces like137a,137b. When the lens is initially extended beyondcannula22, the noted haptic would remain entrapped in the slot which would not yet be exposed outside ofcannula22. When release of the lens is desired, the plunger can be pushed slightly farther to expose the vertical slot and free the trapped haptic. The plunger can then be retracted into the tubular unit16 while the lens remains in the eye.
• In one embodiment, a pair of[0067]resilient spring elements140a,140bextends laterally fromrod122 near the rod's proximal end (FIGS.2-3). The spring elements function to press againstguideways41 when thefree end128 ofrod122 extends beyondcannula22. This engagement withguideways41 forces springelements140a,140bto be pushed backward, and thereby create a biasing force to pull the plunger rearward into tubular unit16. In the preferred construction, the spring elements (not shown) would extend forwardly, generally parallel withrod122, from the front end of the main body. In this arrangement, the spring elements would be designed to curl inward upon engagement withguideways141. Additionally, a coil spring (not shown) may be secured around the plunger/rod to provide the desired biasing force. Of course, other spring arrangements could also be used. The spring may also be omitted and the plunger retracted manually by the surgeon.
• Once the lens has been inspected,[0068]device10 can be assembled. A viscoelastic material, typically used for such surgical procedures, is placed in thecannula22, typically prior to attachment of thecannula22 to the assembly, as a lubricant for the insertion process. Oncedevice10 is assembled, the surgeon inserts the distal end ofcannula22 into theincision142 in theeye14. The surgeon then graspslateral flanges141 and pushes onpad119 to moveplunger18 in a continuous forward motion. (FIG. 1). The continuous movement ofrod122 through tubular unit16 engageslens12 through its distal end128 (FIG. 24). The proximal haptic49aand possibly a portion ofoptic48 are received into and held byslot132, betweenwalls137a,137b. The lens is then pushed forwardly byplunger18 so that the distal side ofoptic48 is shifted transversely towardcover21 by slopedsurfaces59a,59boframps53a,53b; that is, slopedsurfaces59a,59bguide the central portion ofoptic48 away fromflats52a,52b(FIGS. 19 and 20).Inclined surface88 andconical surface91 provide ample clearance for this motion of the lens. As the center of the lens is shifted to move overramps53a,53b, the sides of the lens are forced generally in the direction opposite to the ramps, by theinner wall surface78 ofcover21. Specifically, theconical surface91 incover21causes lens12 to curl intotroughs75a,75b. Continued advancement oflens12 through the tapering passage of tubular unit16 causes continued curling and compression of the lens.
• The lens continues its forward motion until[0069]plunger18pushes lens12 beyondcannula22. In the preferred construction,plunger18 is pushed manually forward in a controlled manner, although other means, such as an electric motor or pneumatic drive, may be used.
• The leading haptic[0070]49bis fed into the distal cul-de-sac152 of thecapsular bag154. Whenlens12 exits fromcannula22, it expands to its full unstressed state (FIGS. 22, 24 and26). The lens, however, remains held in theslot132 ofplunger18. Retention of the lens by the plunger reduces the risk of the lens expelling in an uncontrolled manner from the cannula and damaging the interior of the eye. Retaining the lens with the plunger also provides increased control in placing the lens in the eye. To release the lens, the plunger is retracted into tubular unit16 so that the lens is pushed fromslot132 bydistal end95 of cannula22 (FIG. 23). The retraction ofplunger18 is preferably performed automatically by biasedspring elements140a,140bwhen pressure is released fromthumb pad119. A further implement, or perhapsdevice10 itself, will typically be required to properly position the proximal haptic49aintocapsular bag154.
• The above-discussion concerns the preferred embodiments of the present invention. Various other embodiments as well as many changes and alterations may be made without departing from the spirit and broader aspects of the invention as described in the claims. For example, although the preferred embodiments concern the insertion of a flexible IOL into the eye, the invention is not so limited. The teachings of the present invention are applicable to the insertion of flexible membranes generally, including synthetic membranes, biopolymer membranes, and natural body tissues.[0071]

Claims (7)

What is claimed is:

1. A device for storing, shipping, and inserting an intraocular lens having an optic portion into an eye, said device comprising:

an inserter body having a passage adapted to hold the intraocular lens in an unstressed state with said optic portion suspended to avoid contact thereof with the interior portions of said inserter.

2. The device ofclaim 1 and further comprising a cannula for attaching to said inserter.

3. The device ofclaim 2 wherein the cannula is attached to the inserter prior to shipping said device.

4. The device ofclaim 2 wherein the cannula is attached to the device after shipping and prior to inserting the intraocular lens into an eye.

5. The device ofclaim 1 wherein said storage of the intraocular lens in said device is up to and including ten years.

6. The device ofclaim 1 wherein said passage comprises a staging area compartment having a shelf segment and a removable cover, movable between open and closed positions with respect to said shelf segment.

7. The device ofclaim 6 and further comprising a cannula having opposite, open, proximal and distal ends, said proximal end defining an inner cavity adapted to matingly receive said shelf segment and said cover when said cover is in the closed position.

Images