NZ305154A - Deformable intraocular lens injecting device - Google Patents

Abstract

A surgical implantation device for insertion of a deformable intraocular lens into the eye through a relatively small incision made in the ocular tissue, comprising a lens injecting device having a plunger with a plunger tip configured to provide a side clearance between the plunger tip and lens insertion passageway through the surgical implantation device to accommodate the trailing haptic of the deformable intraocular lens to prevent damage thereto during insertion.

Description

DEFORMABLE INTRAOCULAR LENS INJECTING DEVICE RELATED APPLICATIONS This is a continuation-in-part of U.S Patent Application entitled "DEFORMABLE INTRAOCULAR LENS INSERTION SYSTEM", Senal No 08/221,013, filed on April 1, 1994, allowed, which is a continuation of U.S Patent Application entitled "INTRAOCULAR LENS INSERTION SYSTEM", Senal No 07/953,251, filed on September 30, 1992. now abandoned, both applications fully incorporated by reference herein FIELD OF THE INVENTION This invention relates to a deformable intraocular lens injecting device for use with a lens cartridge Specifically, the present invention is directed to the tip structure of a plunger of the deformable intraocular lens injecting device configured to prevent damage to a trailing haptic of a deformable intraocular lens loaded in the lens cartridge, which lens cartridge is loaded into the lens injecting device BACKGROUND OF THE INVENTION Staar Surgical Company of Monrovia, California has been actively producing and selling deformable intraocular lens since the early 1980s Dr Mozzocco who affiliated with Staar Surgical Company invented and patented the first commercially successful deformable intraocular lens. Dr Mozzocco also developed a number of methods (1 e techniques) and devices for implantation of deformable intraocular lens Staar Surgical Company began distributing a deformable intraocular lens surgical implantation system in 1986, which included a device that became known as the "Staar Shooter" for use with disposable plastic lens cartridges An example of the pnor art "Staar Shooter" device is shown in Figures 34-40 It is important to note the plunger tip of this device was a cylindrical shaped, and had a flat circular end face, as shown in Figure 42 1 WO 96/28122 PCT/US96/03409 The Staar Shooter device was used by surgeons in the United States and around the world in tens of thousands of deformable intraocular lens implantation surgical procedures Even though the "Staar Shooter" device performed very well and was highly accepted and used by practicing surgeons, the device could potentially be improperly operated For 5 example, in a small number of incidences, the trailing haptic of the deformable intraocular lens was damaged by being caught between the plunger tip and inner wall of the passageway through the lens cartridge during insertion Specifically, there existed a small clearance between the outer diameter of the plunger tip and the inner wall of the passageway through the lens cartridge allowing the trailing haptic to potentially enter into a void space created 10 by the small clearance, and then oecome wedged and further wedged as the plunger tip was forced through the passageway in the lens cartridge The forces due to this wedging action were significant in some cases to cause permanent deformation of the trailing haptic due to tensile and shear stress applied to the trailing haptic Another potential for damage to the trailing haptic could occur with the "Staar 15 Shooter", if the deformable intraocular lens was improperly loaded into the lens cartridge Specifically, the entire deformable intraocular lens including the trailing haptic needed to be loaded into the lens cartridge prior to loading the lens cartridge into the lens injecting device A surgeon or surgical support staff personnel could potentially improperly load the deformable intraocular lens with the trailing haptic at least partially extending out of the 20 passageway of the lens cartridge. If the deformable intraocular lens was improperly loaded in this manner, the trailing haptic could easily be damaged by the tip of the plunger of the "Staar Shooter" by being caught between the circular edge of the end face of the plunger tip and the circular edge of the opening into the passageway If the trailing haptic became caught in this manner and further force was applied to the plunger, the circular edge of the 25 end face of the plunger tip and the circular end of the opening in the passageway could cut into the trailing haptic potentially permanently damaging the same These and other situations could potentially occur resulting in permanent damage to the trailing haptic The resulting permanent damage to the trailing haptic is costly, since the damaged deformable intraocular lens must be discarded Further, if the physician did not 30 realize that the trailing haptic was actually damaged during insertion, the damage deformable 2 305154 intraocular lens must then be retrieved from the patient's eye potentially causing eye damage and complications.

SUMMARY OF THE INVENTION These objects relate to at least the preferred embodiments of the invention A first object of the present invention is to provide an improved deformable 5 intraocular lens injecting device ("shooter') A second object of the present invention is to provide an improved deformable intraocular lens injecting device compnsing a plunger having a plunger tip configured to prevent damage to the trailing haptic of the deformable intraocular lens A third object of the present invention is to provide an improved deformable 10 intraocular lens injecting device compnsing a plunger having a plunger tip providing side clearance between the plunger tip and inner wall of the lens cartndge to accommodate the trailing haptic of the deformable intraocular lens to prevent damage thereto dunng insertion A fourth object of the present invention is to provide an improved deformable intraocular lens injecting device compnsing a plunger having a plunger tip having an outer 15 diameter sufficiently less than the inner diameter of the lens cartndge to provide a side clearance between the plunger tip and inner wall of the lens cartndge to accommodate the trailing haptic of the deformable intraocular lens to prevent damage thereto dunng insertion A fifth object of the present invention is to provide an improved deformable intraocular lens injecting device compnsing a plunger having a plunger tip provided with a 20 side groove to provide a side clearance between the plunger tip and inner wall of the lens cartndge to accommodate the trailing haptic of the deformable intraocular lens to prevent damage thereto dunng insertion A sixth object of the present invention is to provide an improved deformable intraocular lens injecting device compnsing a plunger having a plunger tip provided with a 25 side facet to provide a side clearance between the plunger tip and inner wall of the lens cartndge to accommodate the trailing haptic of the deformable intraocular lens to prevent damage thereto dunng insertion.

L .

U > RECE'^IO 51 • The present invention is directed to deformable intraocular lens injecting devices having specially designed plunger tip configurations each providing a side clearance between the plunger tip and inner wall of the lens cartndge to accommodate the trailing haptic of the deformable intraocular lens to prevent damage thereto during insertion 5 The side clearance allows the end of the plunger tip to be placed in direct contact with the deformable intraocular lens when loaded in the lens cartndge without contacting or contacting the trailing hapuc of the deformable intraocular lens in a manner that could potentially damage the same during insertion The side clearance between the plunger tip and inner wall of the passageway through 10 the lens cartndge allows the trailing haptic to be received or accommodated in the void space created by the side clearance in a manner that the trailing hapUc is not subject to tensile or shear stresses dunng the insertion mode. Specifically, the trailing haptic is accommodated so that it cannot be caught between the plunger tip and inner wall of the passageway through the lens cartndge that could potentially compress the trailing haptic by wedge action, twist 15 the trailing haptic causing shear stresses inside the trailing haptic resulting in substantial strain and potential permanently deformation by exceeding the elastic limits of the matenal used to make the trailing haptic Further, the side clearance is preferably made to enclose or capUvate the trailing haptic to maintain the trailing haptic in a certain configuration and again protect it dunng insertion Accordingly, the invention can be said to broadly comprise a deformable intraocular lens injecting apparatus for inserting a deformable intiaocular lens into an eye through a relatively small incision made in the ocular tissue, said apparatus compnsing •a body portion and a nozzle portion, said nozzle portion configured for insertion through the relatively small incision made in the ocular tissue said nozzle portion having a lens delivery passageway extending therethrough, »a plunger having a plunger tip movably disposed in said lens delivery passageway said plunger tip being defined by a distal plunger tip portion extending to a proximal plunger tip portion, said distal plunger tip portion having a substantially constant transverse cross-sectional size and shape, said constant transverse cross-sectional size of said distal plunger tip being less than a transverse cross-sectional size of said proximal plunger tip portion, .t O / (followed by page 4a) RHC 3051 5 •said distal plunger tip portion having a sufficient length and configured to provide a sufficient side clearance space for accommodating a trailing haptic of the deformable intraocular lens, said side clearance space extending from a front edge of said distal plunger tip portion to said proximal plunger tip portion defining the clearance space between said distal plunger tip portion and an inner wall of said lens delivery passageway to accommodate the trailing haptic of the detormable intraocular lens to prevent damage to the trailing haptic during insertion and •said proximal plunger tip portion having the transverse cross-sectional size slightly less relative to a transverse cross-sectional size ot said lens delivery passageway A method according to the present invention (not claimed) includes lubricating the surface of a deformable intraocular lens with a surgically compatible lubricant, and loading the deformable intraocular lens into a lens cartndge in the opened position The lens cartndge is closed while condensing the deformable intraocular lens by a folding action into a shape so that it can be forced through the passageway in the cartndge The lens cartridge is inserted into the lens injecting device with the plunger retracted The plunger is moved forward m a sliding manner by pushing the plunger forward while holding the lens cartndge still This action forces the deformable intraocular lens from the lens holding portion of the lens cartndge into the nozzle portion At this point the threads of the threaded end cap of the plunger engage with the threads of the threaded —— _— 4a (followed by page 5) i LI * *»i H L v- ! FFCC!7r:^ 4 sleeve. The threaded end cap is rotate slightly to engage the threads The device is now ready for the implantation process The nozzle portion of the lens cartridge is placed through a small incision m the eye The threaded end cap of the plunger is rotated or dialed to further advance the deformable intraocular lens forward through the nozzle portion and into the eye. The threaded end cap is further dialed to exposed the tip of the plunger within the eye and push the deformable intraocular lens into position The tip can be used to also rotate the lens within the eye for positioning of the haptics BRIEF DESCRIPTION OF THE DRAWINGS Fig 1 is a perspective view of one embodiment of the surgical implantation device according to the present invention with a lens cartndge positioned in the lens injecting device for implantation of deformable lens structures for placement in the eye Fig 2 is a perspective view of the surgical implantation device shown in Figure 1 with the plunger retracted, and with the lens cartndge removed.

Fig 3 is a side view of the surgical implantation device shown in Figure 2 with the plunger in the extended position Fig 4 is a side elevational view of the surgical implantation device shown in Figure 1 Fig 5 is a detailed longitudinal cross-sectional view of the surgical implantation device shown in Figure 4 Fig 6 is a detailed transverse cross-sectional view of the surgical implantation device, as indicated in Figure 5 Fig 7 is a detailed end view of the surgical implantation device, as indicated in Figure 5 Fig 8 is an enlarged detailed left side elevational view of the tip of the plunger in the spacial onentation as shown in Figure 1 Fig 9 is an enlarged detailed end view of the tip shown in Figure 8 Fig 10 is an enlarged detailed top planar view of the tip of the plunger WO 96/28122 PCT/US96/03409 * Fig 11 is an enlarged detailed right side elevational view of the tip of the plunger in the spacial orientation, as shown in Figure 4 Fig 12 is an enlarged detailed bottom view of the tip of the plunger m the spacial orientation, as shown in Figure 1.

Fig 13 is a perspective view of a deformable intraocular lens for use in the present invention.

Fig 14 is a perspective view of another type of deformable intraocular lens for use in the present invention Fig 15 is a side view of the lens shown in Figure 13.

Fig 16 is a perspective view of the lens cartridge shown m the open position to allow a deformable intraocular lens to be loaded therein Fig 16A is another perspective view of the lens cartndge shown in the open position Fig 17 is a rear end elevational view of the lens cartndge shown in the open position Fig 18 is a front end elevational view of the lens cartndge shown in the open 15 position Fig 19 is a rear end elevational view of the lens cartndge shown in the closed position Fig 20 is a front end elevational view of the lens cartndge shown in the closed position Fig 20A is a detailed end view of the nozzle portion showing three (3) slots of different length equally spaced about the circumference of the tip Fig 20B is a detailed perspective view of the tip showing the three (3) slots of different length Fig 21 is a top planar view of the lens cartridge shown in the open position 25 Fig 22 is a side elevational view of the lens canndge shown in the closed position Fig. 23 is a rear end elevational view of the lens cartndge shown in the closed position Fig. 24 is a broken away side view of the device showing the lens cartndge in relationship to the plunger in the retracted position. 6 * • Fig. 25 is a broken away side view of the surgical implantation device showing the lens cartndge in relationship to the plunger in a partially extended position Fig. 26 is a broken away side view of the device showing the lens cartndge in relationship to the plunger in a fully extended position.

Fig 27 is a perspective view showing the device positioning a deformable intraocular lens within the eye Fig. 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 implantation device Fig 29 is a cross-sectional view of an eye showing the positioning of the deformable 10 intraocular lens into a different position in the eye by the surgical implantation device Fig 30 is a side elevational /lew of an alternative embodiment of the lens cartndge provided with a beveled tip Fig 31 is a rear end elevational view of another alternative embodiment of the lens cartndge provided with grooves m the passageway to facilitate folding the deformable 15 intraocular lens m an open position Fig 32 is a rear end elevational view of another alternative embodiment of the lens cartndge provided with grooves in the passageway to facihtate folding the deformable intraocular lens in a closed position Fig 33A is a front end elevational view of the nozzle portion of an alternative 20 embodiment of the lens cartndge Fig 33B is a front end elevational view of the nozzle portion of a further alternative embodiment of the lens cartndge Fig 34 is a detailed side elevational view of another embodiment of the plunger tip contacting with the deformable intraocular lens inside the lens injecting passageway 25 Fig 35 is a detailed end elevational view of the plunger tip shown in Fig 34 Fig 36 is a detailed side elevational view of a further embodiment of the plunger tip contacting with the deformable intraocular lens inside the lens injecting passageway Fig 37 is a detailed end elevational view of the plunger tip shown in Fig 36 7 Fig 38 is a detailed side elevational view of an even further embodiment of the plunger tip contacting with the deformable intraocular lens inside the lens injecting passageway Fig 39 is a detailed end elevational view of the plunger tip shown in Fig. 38 5 Fig 40 is a detailed side elevational view of another further embodiment of the plunger tip contacting with the deformable intraocular lens inside the lens injecting passageway Fig 41 is a detailed end elevational view of the plunger tip shown in Fig 40 Fig 42 is a detailed side elevational view of a prior art plunger tip 10 Fig 43 is a perspective view of a prior art lens injecting device Fig 44 is a longitudinal side cross-sectional view of the prior art lens injecting device shown in Fig 43 Fig 45 is a side elevational view of a prior art disposable plastic lens cartndge Fig 46 is a longitudinal cross-secticnal view of the lens cartndge shown in Fig 45 DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS A device according to the present invention compnses a deformable intraocular lens injecting device having a plunger tip configured to provide a side clearance between the plunger tip and inner wall of a lens injecting passageway The present invention can be applied to the plunger tip of a separate deformable 20 intraocular lens injecting device to be used with a separate lens cartndge (i.e two-piece system such as disclosed herein), or can be applied to the plunger tip of an intraocular lens injecting device having a lens injecting passageway itself (i e one-piece system such as disclosed in U S. patent 5,275,604 to Rheinish, fully incorporated by reference herein) A preferred embodiment of a deformable intraocular lens surgical implantation device 25 10 according to the present invention is shown in Figures 1-3 The surgical implantation device 10 compnses a lens cartndge 12 disposed within a lens injecting device 13 The lens injecting device compnsing a lens injecting body 14 with a side receiver 15, and a movable plunger 16 In Figure 1, the side receiver 15 is defined by an opening 17 through the wall 8 5 1 of the lens injecting body 14 of the size and shape shown in Figures 1 and 2 The opening 17 is defined by parallel edges 17a, 17a, which are suificiently spaced apart to allow the lens cartndge 12 to be loaded into the side receiver 15 of the lens injecting device 13, tapered edges 17b, clamping edges 17c, and stop edge 17d In Figure 1, the lens cartndge 12 is 5 positioned in the side receiver 15 between the clamping edges 17c with the plunger extending through the lens cartndge 12 in a position, for example, after a lens implantation procedure In Figure 2, the le-is cartndge 12 is shown removed from the lens injecting device 13 with the plunger 16 in a ~e.trac.ied position for allowing the lens cartndge 1? containing a loaded lens and its haptic to be iirerted within the len , -pacing device 13 In Figure 3, 10 the lens injecting device 13 is shown with the plunger 16 in the extended position without the lens cartndge 12 for purposes of illustration of the components The plunger 16 is fitted with a threaded end cap 18 ai 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 ,i allow a person to tightly gnp the cap 18 with his or her finger tips The threaded end 15 cap 18 is received within a threaded sleeve 24 of the lens injecting body 14 The threaded end can 18 can be a separate component attached to the lens injecting device 13, or integral therewun, as shown in the construction is Figure 5 The plunger 16 is installed within the lens injecting device 13 in a manner to allow the plunger 16 to be reciprocated therein In the illustrated embodiment, the plunger 16 is 20 supported for sliding movement within the lens injecting device 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 lens injecting body 14 to allow the guide to be inserted within the lens injecting body 14 Dunng construction, the guide 26 is inserted within the lens injecting device 13, and locked into position by pin 28 inserted into a prednlled hole in both 25 the wall of the lens injecting device 13 and guide 26 In an alternative embodiment, the guide 26 is delete and the pin 28 is utilized to prevent rotation of the plunger 16 by the pin 28 nding along the flat side of the plunger 16, as shown in Fig 5 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 r) /, J"- w | RFCEIVTO prevents the plunger 16 from rotating within the lens injecting device 13 to maintain the orientation of the tip 20 relative to the lens injecting device 13 dunng operation.

The threaded end cap 18 is connected to the plunger 16 m 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 can be made with external threads 34 and a longitudinal center bore 36 that ends on the nght side of the threaded end cap 18 leaving an end wall 38.

The end wall 38 is provided with a hole slightly larger than the outer diameter of the threaded extension 30 to allow the threaded end cap 18 to freely rotate on the plunger 16 while being secured to the end of the plunger 16 Dunng 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 end cap 40 is press fitted into the end of the center bore 36, and seal the center bore 36 to prevent debns from entenng therein dunng use Alternatively, the threaded extension 30 can be replaced with an interference type connection (e g snap fit type) between the modified extension and threaded end cap 18 to facilitate quick assembly 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 20 structure provides means for inserting the deformable intraocular lens into the 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 cyhndncal surface 48 The nght side of the tip 20 shown in Figure 9 is provided with a concave surface facet 47 conical surface 46, and cyhndncal surface 48 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 cyhndncal 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 i 1 5154 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 Figure 14 includes a lens body 62 and attachment means defined by a pair of lateral lobes 64 of the lens portion 62. 5 The details of the preferred lens cartndge 12 are shown in Figures 16-20 The lens cartndge 12 compnses a lens holding portion 66 extending to a transition portion 67 and an implantation nozzle portion 68 When the lens cartndge 12 is in a closed position, a continuous circulai or oval passageway of the same diameter extends through the lens holding portion 66 through the transition portion 67 and through the implantation nozzle portion 68 10 The lens cartndge 12 is preferably made of mjecUon molded plastic such as polypropylene The lens holding portion 66 is defined by a fixed portion 70 and a movable portion 72 The fixed portion 70 is fixed relative to the implantation nozzle portion 68, and is defined by a tubular portion 74 and extension 76 The movable portion 72 is movable relative to the fixed portion 70 for opening and closing the lens holding portion The movable portion 72 is 15 defined by a tubular portion 78 and extension 80 A hinge 82 is provided between the fixed portion 70 and movable portion 72 The hinge 82 is defined by reducing the thickness of the walls of the tubular portion 74 and 78 at the hinge 82, as shown in Figures 17, 18 and 19 The hinge 82 runs the length of the lens holding portion 66 to allow the extensions 76 and 80 to be split apart, or brought together to open and close, respectively, the lens holding 20 portion 66 The tubular portion 78 of the movable portion 72 is provided with a sealing edge 84, which is exposed when the lens cartndge 12 is opened, as shown in Figure 16A, and seals with a similar sealing edge 86 (See Figure 17) of the transition portion 67 when the lens cartndge 12 is closed 25 The end of the nozzle Up 69 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 nozzle tip 69 is the shortest, slot 87c on the nght side of the nozzle 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 nozzle up 69 11 r r i L i r- Other embodiments of the lens cartndge 12 according to the present invention are shown in Figures 30-33 The lens cartndge 12 shown in Figure 30 is provided with a beveled tip 94 to facilitate entry of the tip through the incision in the eye dunng implantation The beveled 5 Up 94 can be set at approximately forty-five (45) degrees relative to the passageway through the lens cartndge 12 The embodiment of the lens cartndge 12 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 lens cartndge 12 to facilitate bending of the lens 10 Specifically, the edges 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 lens cartndge 12 when the lens cartndge 12 is being folded into the closed position The embodiments of the lens cartndge 12 shown in Figures 33A and 33B each have a nozzle portion 68' having an oval cross-section with slots 87' differently position as shown, 15 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 vanous features of the lens cartndges 12 shown in Figures 16-21 and 30-33 can be used in vanous combinations to achieved an optimum design for a particular application However, all of these features are typically considered improvements of the basic 20 combination The components of the device 10, except for the lens cartndge 12, are preferably fabncated from autoclavable matenal such as stainless steel or from a disposable ngid plastic such as medical grade ABS or the like ALTERNATIVE PLUNGER TIP CONFIGURATIONS Additional embodiments of plunger tips are shown in Figures 34 to 41 These plunger tips all provide a side clearance between the plunger tip and lens insertion passageway to accommodate the trailing haptic 12 WO 96/28122 PCT/US96/03409 In Fig 34, a plunger tip 100 is shown contacting with the deformable intraocular lens 54 in the lens injecting passageway P while accommodating the trailing haptic 58b between plunger tip 100 and inner surface wall of the lens injecting passageway P The plunger tip 100 compnses a distal plunger tip portion 102 having a cyhndncal 5 shape and a proximal plunger tip portion 104 having a cyhndncal shape, as shown in Figs 34 and 35 The distal plunger tip portion 102 is offset a distance D from the proximal plunger tip portion 104 to provide a larger side clearance on one side of the distal plunger tap portion 102 than on an opposite side thereof The onentation of the offset of the distal plunger tip portion 102 relative to the proximal plunger tip portion 104 can be vaned to 10 accommodate the trailing haptic due to its location and onentation inside the lens injecting passageway P depending on the folding technique and placement technique of the deformable intraocular lens inside the lens injecting passageway P Further, the trailing haptic can be configured so as to at least partially wrap around the distal plunger tip portion 102 The cross-sectional shapes of the distal and proximal plunger tip portions can be vaned 15 In Fig 36, a plunger tip 200 is shown contacting with the deformable intraocular lens 54 in the lens injecting passageway P while accommodating the trailing haptic 58b between plunger tip 200 and inner surface wall of the lens injecting passageway P The plunger tip 200 compnses a side groove 202 having an end portion 204 for accommodating the trailing haptic 58b, as shown in Figs 36 and 37 The location of the 20 side groove 202 around the penphery of the plunger tip 200 can be vaned to accommodate the trailing haptic 58b due to its location and onentation inside the lens injecting passageway P dependmg on the folding technique and placement technique of the deformable intraocular lens 54 into the lens injecting passageway P The shape of the side groove 204 when viewing the side of the plunger tip 200 can 25 be vaned from rectangular to tnangular, parallelogram shaped, curved edges, partial circular shaped and other suitable shapes Further, the depth of the side groove 204 can be increased or decreased In addition, the cross-sectiona] shape of the side groove 204 can be changed from half circle to rectangular, tnangular, C-shaped, parallelogram and other suitable cross-sectional shapes 13 In Fig 38, a plunger tip 300 is shown contacting with the deformable intraocular lens 54 in the lens injecting passageway £ while accommodating the trailing haptic 58b between plunger tip 300 and inner surface wall of the lens injecting passageway P The plunger tip 300 compnses a side facet 302 having an end portion 304 for accommodating the trailing haptic 58b, as shown in Figs. 38 and 39 The location of the side facet 302 around the penphery of the plunger tip 300 can be vaned to accommodate the trailing haptic 58b due to its location and onentation inside the lens injecting passageway P depending on the folding technique and placement technique of the deformable intraocular lens 54 into the lens injecting passageway P The shape of the side facet 304 when viewing the side of the plunger tip 300 can be vaned from rectangular to tnangular, parallelogram shaped, curved edges, partial circular and other suitable shapes Further, the depth of the side facet 304 can be increased or decreased In addition, the cross-sectional shape of the side facet 304 can be changed from half circle to rectangular, tnangular, C-shaped, parallelogram and other suitable cross-sectional shapes The number of facets and type of facets can also be vaned depending on the requirement for the particular lens injection application In Fig 40, a plunger tip 400 is shown contacting with the deformable intraocular lens 54 in the lens injecting passageway P while accommodating the trailing haptic 58'o between plunger tip 400 and inner surface wall of the lens injecting passageway P The plunger tip 400 compnses a cyhndncal distal plunger tip portion 402 concentric with a cylindncal proximal plunger tip portion 404, as shown in Figs 40 and 41 The location of the length of the cyhndncal distal plunger tip portion 402 can be varied Further, the cross-sectional shapes of the distal and proximal plunger tip portions can be varied The end faces of the plunger tips in the embodiments shown in Figs 34 to 41 are flat planar circular end faces The configuration of these end faces can be vaned to include one or more concave, convex, faceted, curved surface configuration and peripheral shapes depending on the particular lens injection application 14 ' ' r i- • L < -■ L_ RrCE,w^n * METHODS OF IMPLANTATION The surgical procedure begins by coating the lens with a surgically compatible lubricant, and loading the lens into the lens cartndge 12. For example, as shown in Figure 21, a lens 54 having a lens body 56, a leading haptic 58a is loaded into the lens cartndge 12 while a traibng haptic 58b remains trailing outside the lens cartndge 12 in the manner shown Specifically, the lens 54 is loaded downwardly into the opened lens cartndge 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 edges of the lens 54 are held by edges 88 and 90 of the tubular portions 74 and 78, respectively The rear edge of the lens 54 is placed approximately at the rear edge of the lens cartndge 12 The lens 54 is further manipulated to situate the haptics 58a and 58b in the manner shown. Specifically, haptic 54a is positioned in a leading position and the other haptic 54b is positioned in a trailing position outside the lens cartndge with respect to the direction of implantation, as indicated by the arrow Subsequently, the lens holding portion 66 of the lens cartndge 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 portions 74 and 78 bend and fold the lens 54 ■> 'hen 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 conforms to the curved inner surfaces of the tubular portions 74 and 78 without damage thereto, as shown in Figure 23 The lens cartndge 12 containing the loaded lens 54 is inserted between the edges 17a, 17a of the opening 17 into the lens cartndge receiver 15 of the lens injecting device 13 As the lens cartndge 12 is moved forward, the extensions 76 and 80 move past the tapered edges 17b, 17b and come to a stop position between the clamping edges 17c, 17c when front portions of the extensions 76 and 80 contact with the stop edge 17d The clamping edges 17c prevent rotation of the lens cartndge 12 inside the lens injecting device 13 The user pushes the threaded end cap 18 forward while secunng the lens injecting body 14 from movement, forcing the plunger 16 forward within the lens injecting device 13 As the plunger 16 is moved forward, the tip 20 enters into the rear of the lens cartndge 12 and misses the trailing haptic 58B until the tip makes contact with the loaded lens 54, as WO 96/28122 PCT/US96/03409 4 shown m Figure 24 As the plunger 16 is moved forward m this manner, the lens 54 previously lubricated, is forced into the implantation nozzle portion 68 of the lens cartndge 12, as shown in Figure 25 Once the deformable intraocular lens 54 enters the implantation nozzle portion 68, the 5 threads of the end cap 18 contact with the threads of the sleeve 24 stopping further movement of the plunger 16 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 implantation device is ready for the implantation step The nozzle tip 69 of the nozzle portion 68 is insert through the incision in the eye, and the end cap 18 is rotated to continue 10 the forward movement of the plunger 16 by continued rotation of the end cap 18 relative to the lens injecting body 14 to expel the lens from the nozzle tip 69 into the intenor 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 dunng the implantation procedure The 15 deformed lens after exiting the nozzle portion 16 returns to its ongmal 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 20 within the eye without the aid of other surgical instruments The configuration of the tip 20 is important dunng the implantation process The faceted tip 20 provides a clearance between the tip 20 and the inner surface of the passageway through the lens cartndge 12 to accommodate the trailing haptic 58b dunng movement of the lens within the lens cartndge 12, as shown in Figures 25 and 26 25 Specifically, there exists a sufficient clearance between the flat surface facet 44 and the inner wall of the passageway through the lens cartndge 12 Dunng the implantation process, the trailing haptic 58b floats around in the space between the extension 42 of the 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 dunng 16 WO 96/28122 PCT/US96/03409 4 the implantation process. The leading haptic 58a moves through the passageway unimpeded dunng the implantation process preventing any damage thereto 17 W 305154 18

Claims (24)

1. WHAT WE CLAIM IS

   1 A deformable intraocular lens injecting apparatus for inserting a deformable intraocular lens into an eye through a relatively small incision made m the ocular tissue, said apparatus comprising

   •a body portion and a nozzle portion, said nozzle portion configured for insertion through the relatively small incision made m the ocular tissue, said nozzle portion having a lens delivery passageway extending therethrough,

   •a plunger having a plunger tip movably disposed m said lens delivery passageway, said plunger tip being defined by a distal plunger tip portion extending to a proximal plunger tip portion, said distal plunger tip port.cn having a substantially constant transverse cross-seccicnal size and shape, said constant transverse cross-sectional size of said distal plunger tip being less than a transverse cross-sectional size of said proximal plunger tip portion,

   •said distal plunger tip portion having a sufficient length and configured to provide a sufficient side clearance space for accommodating a trailing haptic of the deformable intraocular lens, said side clearance space extending from a front edge of said distal plunger tip portion to said proximal plunger tip portion defining the clearance space between said distal plunger tip portion and an inner wall of said lens delivery passageway to accommodate the trailing haptic of the deformable intraocular lens to prevent damage to the trailing haptic during insertion, and

   •said proximal plunger tip portion having the transverse cross-sectional size slightly less relative to a transverse cross-sectional size of said lens delivery passageway
2. 2 An apparatus according to claim 1, wherein said proximal plunger tip portion is cylindrical
3. 3 An apparatus according to claim 2, wherein said distal plunger tip portion is cylindrical

   19
4. 4 An apparatus according to claim 3, wherein said cylindrical distal plunger tip portion is aligned relative to said cylindrical proximal plunger tip portion
5. 5 An apparatus according to claim 3, wherein said cylindrical distal plunger tip portion is located off-axis relative to a centered longitudinal axis of said cylindrical proximal plunger tip portion
6. 6 An apparatus according to claim 1, wherein said distal plunger tip portion is provided with a groove to provide side clearance to accommodate the trailing haptic of the deformable intraocular lens
7. 7 An apparatus according to claim 6, wherein said distal plunger tip portion is cylindrical
8. 8 An apparatus according to claim 7, wherein said proximal plunger tip portion is cylindrical
9. 9 An apparatus according to claim 8, wherein said cylindrical proximal plunger tip portion and said cylindrical distal plunger tip portion have a constant outer diameter
10. 10 An apparatus according to claim 1, wherein said distal plunger tip portion is provided with a flat side facet
11. 11 An apparatus according to claim 10, wherein said distal plunger tip portion is cylindrical
12. 12 An apparatus according to claim 11, wherein said proximal plunger tip portion is cylindrical
13. 13 An apparatus according to claim 12, wherein said cylindrical distal plunger tip portion and said proximal plunger tip portion have a constant diameter

    I RFr^lvrn 1

    •
14. 14 An apparatus according to claim 1, wherein the lens injecting apparatus is defined by at least two separate components including a lens injecting device having a lens cartridge receiver and a lens cartridge
15. 15 An apparatus according to claim 14, wherein said lens cartridge includes a lens holding portion connected to said nozzle portion
16. 16 An apparatus according to clam 15, wherein said lens delivery passageway is provided with at least one groove
17. 17 An apparatus according to claim 16, wherein said lens delivery passageway is provided wich a pair of opposed grooves
18. 18 An apparatus according to claim 17, wherein said lens delivery passageway includes an inwardly tapering portion
19. 19 An apparatus according to claim 18, wherein said lens delivery passageway includes an inwardly tapering portion
20. 20 An apparatus according to claim 1, wherein said lens delivery passageway is provided with at least one groove
21. 21 An apparatus according to claim 20, wherein said lens delivery passageway is provided with a pair of opposed grooves
22. 22 An apparatus according to claim 21, wherein said lens delivery passageway includes an inwardly tapering portion
23. 23 An apparatus according to claim 20, wherein said lens delivery passageway includes an inwardly tapering portion.
24. 24 An apparatus according to claim 1, wherein said lens delivery passageway includes an inwardly tapering portion

    30 5154

    20

    PECC^'rn j

    jAi.

    w

    2 5 A deformable intraocular lens injecting apparatus according to any one of claims 1-24 substantially as herein described with or witnout reference to the accompanying drawings

    305154

    a \IFD\PGJ\D0CS\379159 ^

    By the authorised agents A J PARK & SON Per

    1 / L i

    RECf:!V(;0