CA1093756A

CA1093756A - Method of making an intra-ocular lens

Info

Publication number: CA1093756A
Application number: CA277,805A
Authority: CA
Inventors: Stanley Poler
Original assignee: Individual
Current assignee: Individual
Priority date: 1976-05-28
Filing date: 1977-05-05
Publication date: 1981-01-20
Also published as: FR2352537A1; CH616330A5; BR7703457A; ES469677A1; IL51968A; FR2352537B1; ES469636A1; JPS52146650A; DE2723518C2; NL176524B; NL176524C; DE2723518A1; NL7705599A; ES459228A1; HK9382A; IL51968A0; JPS5815141B2; GB1583193A; MX146884A

Abstract

METHOD OF MAKING AN INTRA-OCULAR LENS

ABSTRACT OF THE DISCLOSURE

The invention contemplates improved techniques for making lens implants for use in ophthalmological surgery, the lens being a replacement for a cataract-clouded natural lens, and the replacement being installed in the pupil at the iris as the operative step following removal of the cataracted lens. The lens produced by the inventive method features adapter structure assembled to an intra-ocular lens element and having first and second pluralities of radially outward stabilizing feet, in angularly spaced and interlaced relation with the feet of the other plurality, and the respective pluralities of stabilizing feet are on opposite sides of the iris, thus enabling the iris to retain and position the implanted lens.

Description

5~

The invent~on relates to methods of making an improved lens implant, as a replacement for a cataract~clouded or other~ise diseased natural lens.
As many as 500,000 Americans a year require surgery for removal of a natural lens which has become opaque ~cataract), causing loss of vision.
~le modern therapy for cataract is surgical removal; this is generally done either by gently lifting the opaque lens from the eye in one piece, or by fragmenting the lens and washing out the fragments. When the cataractous lens is removed, an alternate method must be provided to focus light entering the eye, so that a sharp image focuses at the retina. Strong spectacle lenses and contact lenses are both commonly used for this purpose, but both have im-portan~ shortcomings. Strong spectacle lenses tremendously enlarge the image, foreshorten distances, restrict peripheral vision, and prevent both eyes from being used simultaneously if both eyes have not had cataract surgery; contact lenses overcome some of these problems but introduce others, involved in in-sertion, removal and frequent maintenance.
The concept of implanting an intra-ocular lens in place of the re-moved natural lens is not new, although it is of relatively recent origin. To date, however, a significant limitation on such a procedure has been the re-lative unavailability of implant lenses, for their production has relied upon small, craft-style workshops~ and lens quality has been less tllan satisfactory.
It is accordingly an object of the invention to provide an improved method for making intra-ocular lenses, for implan~ procedures of the char-acter indicated.
Another object is to provide a method for making improved mounting structure for such lenses, whereby operative procedures may be more safely and reliably per~ormed.
It is also an object to provide a method for making such lenses com-plete with mounting structure, of inherent high quality, adherence to speci-fications, and reproducibility by precision mass-production techniques.
Thus, in accordance with a broad aspect of the invention, there is 3'~S~
provided, as an article of manufacture, a single~piece weld~free mounting adapter for iris~stablized mounting of an intra~ocular len$ element, compris-ing a circumferentially continuous ring body ~hich is centrally open and which is of peripheral contour generally conforming to the peripheral contour o -the lens element, plural inwardly extending angularly spaced anchoring ele-ments integral with said ring body for 0ngagement with spaced local p0riph0ral r0gions of the lens, and first and second pluraliti0s of lens-positioning f0et int0gral with said ring body and radi.ally outwardly 0xtending therefrom in angularly spaced and interlaced relation, the feet of on0 plurality b0ing 1~ in axially offset r01ation to the fe0t of th0 other plurality.
In accordance with another broad aspect of th0 invention, th0r0 is provided, as an articl0 of manufactur0, an optically finished i.ntra-ocular 10ns 010m0nt having a continuous p0riph0ry about its optical axis, and a single-piece weld-free integrally formed moun~ing adapter therefor, said adapter comprising a peripherally continuous ring body which is centrally open and wi~ich is in retaining assembly to peripheral regions of said lens element, and first and second pluralities of lens-positioning feet integral with said ring body and radially outwardly extending therefrom in angularly spaced and interlaced relation, the feet of one plurality being in axially offset relation to the fee~ of the other plurality.
According to another broad aspect of the invention, there is pro-vided, as an article of manufactur0, an optically finished intra-ocular lens el0ment having a continuous p0riph0ry about its optical axis, and a single-piece integrally formed weld-free ring-like mounting adapter therefor, said adapter b0ing centrally op0n and having compliant lens-0ngaging means for axially retaining peripheral engagement with said lens 010ment, and said adapt0r-further comprising first and second pluralities of lens-positioning feet integral with said ring body and radially outwardly extending ~herefrom in angularly sp~ced and interlaced relation, the feet of one plurality being ~O in axially offset relation to the feet of the other plurality.
Other objects and various further features of novelty and invention ~la-.

~3~rj~

will be pointed out or will occur to those skilled in the art from a readingof the following specification, in conjunction with the accompanying drawings.
In said drawings, which show, ~or illustrative purposes only, pref~rred forms of the invention:
Figure 1 is an enlarged view in perspective, showing an intra-ocular lens and unitary mount o-F the invention, ready for opera~ive implant-ation, as in the course of a cataract operation;
Figures 2 and 3 are plan views of the unitary mount of Figure 1, Figure 2 being to show an interim formative condition, and Figure 3 showing the fully formed mount ready for assembly to the lens element;
Figures 4, 5 and 6 are fragmen~ary sectional views taken at *he planes 4, 5 and 6 indicated in Figures 1 and 3;
Figure 7 is a view similar to Figure 3 to show a modification;
Figure 8 is an enlarged fragmentary view of the structure of Fig-ure 7, to permit identlfication of dimensional features;
Figure 9 is a fragmentary sectional view~ with solid outlines as taken at the plane 9, and with phantom outlines as taken at the plane 9' of Figure 7;
Figure 10 is a view similar to Figure ~ to show a modification;
Figures 11 and 12 are perspective views to show further modifica-tions;
Figures 13 and 14 are plan and perspective views to show the blank form and the ultimately bent confi.guration of a mounting that is particularly adapted to manufacture from a plastic material;
Figure 14A is a fragmentary ~iew similar to Figure 14, to show a variation;
Pigure 15 is a fragmentary p].an view of a photographically dupli-cated plurality of lens-mount blanks, in side-by-side severably connected multiple; and Figures 16 and 17 are plan and fragmentary plan views similar to ~3'~5~

Figures 14 and 15, to illustrate another application of the method of the invention.
Referring to Figures 1 to 6, the invention is shown in application to an implan~ lens 10 of non-toxic transparent plastic, such as methylmetha-crylate. Lens 10 is of such refractive index and is so groun(l that when mounted at the iris and immersed in the intro-ocular, the thus-implanted eye will develop sharp image focus at the retina. Lens 10 is typically although not necessarily circular about its optical axis; it may, for example, be o~
5-mm diameter and have a peripheral-edge thickness T of l-mm or less.
In accordance with the invention, uni*ary mounting s~ructure 11 is secured to lens 10 and provides first and second pluralities of radially out-ward feed for axially s~abilized positioning reference to the iris, the feet of one plurality being axially offset from and angularly interlaced with those of the other plurality, so that both sides of the iris contribute to stability.
As shown, a circumferentially continuous ring 12 conforms to the peripheral contour of the edge of lens 10, being positioned adjacent one face of the lens.
The first plurality of feet comprises three angularly spaced rods 13 extend-ing radially outward for retention adjacent the outer side (anterior surface) of t~e iris, with the pupilary border of the iris itself closing upon the circular edge of the lens. The second plurality of feet comprises three radially outward loops 14 in a radial plane which is axially offset from ring 1~, to substantially the extent T. Thus, each of the feet 14 includes two spaced short offset leg portions 15 which engage the circular edge of lens 10, and the radial loop portion extends frvm the leg portions 15. ~or the case of the plastic lens 10 of Figure 1, six L-shaped anchoring prongs 16-17 extend first radially inwardly and then axially re~rwardly, the same being embedded into adjacent rim regions of the lens 10.
The described mounting structure or adapter 11 may be a single piece of metal, with all anchoring prongs 16-17 and stabilizing feet 13-14 integral-ly formed with the body ring 12. The metal is inert to body tissue and fluids ~ ~ ~ 3~7 ~ ~7 and is suitably stainless steel, of thickness in the order of 0.1-mm. I
have found it practical to construct the "blank" of Figure 2, for the mount-ing structure 11, by employing photographic and etching techniques.
More specifically, for the case of the "blank" of Figure 2, a draw-ing was initially prepared, to greatly enlarged scale, e.g.~ ~0 times. This drawing was photographically reduced to ultimate size, and multiplied at in-dexed locations to produce a photographic negative with plural reduced im-ages of the drawing. Then, one of a class of metals which was tolerated by the body ~e.g., stainless steel, platinum, irridium, etc.) was coated with a photosensitive material. The negative was placed in contact with the photosensitive coat, exposed to light, and then developed in a "photographic reversal", thus removing from the exposed surface those areas which have been exposed to Iight. The sheet that was left was then placed in a chemical solution (ferric chloride) which etched away unwanted material~ leaving only a completed profile of the 1'blank'l. The described etching process has the advantage that it tends to produce round, burr-free edges, and it can use materials that are lighter and thinner than anything which to my knowledge and belief has been available to date.
Figure 2 depicts the "blank" *hus prepared, it being noted that lobes 14' are of extended radial projection, in order to account both for the offsets 15 and the loops 14; by the same token, the barbs 16'-17' are of extended inward radia~ projection, in order ~o account for both the radially inward and the axially inward leg portions of prongs 16-17. Bending dies are employed to operate upon the "blank'7 of Figure 2, such that all neces~
sary axial offsets are produced, resulting in reduction o~ the overall circle defined by legs 14 and expansion of the circle defined by prongs 16-17, all as appears from comparison of the '7before" and "after" plan views of Fig-ures 2 and 3.
To complete the description of an actual physical em~odiment of 3~ Figures 1 to 6, I indicate that each of the retaining rod-like feet 13 ~ ~ ~ 3-~t~

terminates with a small knob formation, to avoid presentation of any sharp edge to irritate iris tissue. These knobs are on a circle of 7.5 nlm diameter, and the outer limits of legs 14 are on a circle of 8-mm diameter. The prongs 16-17 are bent axially at a location radially inwardly offset about 0.15-mm from the body ring 12; they are embedded into lens 10 to the extent of about 0.30-mm in the axial direction. Such embedding may be accomplished without drilling, by axially directed ultrasonic driving impulses applied at prongs 16-17, while retaining ring ~12) and leg (13-14) parts of the adapter 11 in damped condition. The optical distortion of lens 10 due to such driven as-sembly of the adapter to the lens is negligible.
In the embodiment of Figures 7 to 9, the layout of the adapter "blan~" is generally as described for Figure 2, with the exception tha~ the radius Rlof the body ring 12' exceeds the radius R2 of the lens 10' about its optical axis to an extent ~ R which is slightly less than the effective radially inwardly projecting extent ~ R' of the anchoring barbs 16'-17'.
The interlaced pluralities of radially outward stabilizing feet ]3'-14' are in axially offset relation, each plurality being offset in the direction opposite the other plurality, as is apparent from Figure 9. To assemble the adapter of Figure 7 to its lens lO', the body ring 12' is transiently dis-torted by suitable tooling, in approach to a polygonal shape; the action of such tooling is denoted by radially inward and radially outward arrows which symbolize local force application to transiently radially outwardly displace all barbs 16'-17' to clear the outer-edge on rim radius R2 of lens 10'. Once axially centered around this rim, the tooling is relaxed to allow compliant restoration, barbs 16'-17' contact ~he lens rim and are then driven into short radial local embedment in the lens, as by ultrasonic tool means. The assembly is then complete and ready for sterilization and implantation.

Figure 10 illustrates a slight modification of Figures 7 to 9~
wherein ~he ring body 12" is a~ one axial end of lens 10" and the pluralities of stabili?ing feet 13"-14" determine iris retention in a plane that is .',........ ~

axially offset from lens lO". The barbs 16"-17" are longer than previously described, to permit an axially offsetting projection from ring 12" before radially inward bending to engage and become locally radially embedded at spaced locations along the rim of lens 10".
In the embodiment of Figure 11, the rim of lells 20 has a peripheral groove 21, and the unitary mounting adapter 22 is so formed as to permanent-ly assemble by resilient snap ac~ion into the groove 21. Adapter 22 may still be formed from a si.ngle piece "blank" by the indicated photo-chemical technique, and it may still be a circumferentially continuous structure. As shown, the looped legs 23 comprising one plurality of locating :Eeet integral-ly connect adjacent ends of spaced body-ring arcs 24, and the rod-like feet 25 of the other plurality extend radially from the respective arcs 24; axial offset of -these pluralities is built into legs 23, in the manner general.ly as described at 15 in Figure 1, except for a small initial radially outward offset in such legs 23 at juncture with arcs 24. In unstressed condition, the arcs 24 are of curvature conforming to that of groove 21 and are prefer-ably at a slight radially inwardly displaced position with respect to the circle of groove 21. To assemble to lens 20, arcs 24 are outwardly spread against the compliant action of loops 23, in order to permit placement and resilient snap retention of arcs 24 in groove 21. The assembly is then ready for sterilization and implantation.
In the embodiment of Figure 12, the circular body ring 30 of a uni-tary adapter 31 is retained in its assembly to a lens 32 by radially inward barbs 33-34 of one plurality (33) which engage over one axial end of lens 32 and of another plurality ~34) interlaced with the barbs of the first plur-ality and engaging over the othsr axial end of lens 32, thus retaining the assembly without resort to mechanical embedment in lens material.
As sho~, the iris-stabilizing feet 35 of one plurality are spaced radial rods a~ the ring locations of barbs 34, and barbs 34 include axial offsets to the extent of lens-rim thic~ness. The feet 36 of the other . - ~

plurality include axial offsets at juncture to the body ring 30~ at which lo-cations barbs 33 also extend radially inward. ~eet 36 differ from the loops already described in that they are somewhat coiled or looped in a common radial planeJ the free end of the coil belng apertured at 37. Figure 12 will be understood to depict the unstressed normal condition and orienta-tion of feet 36.
In accordance with a feature of the invention, the inherent re-silien-t compliance of feet 36 and their apertured ends 37 are employed to facilitate operative insertion through the pupil of the iris. In preparation, a suture 3~ such as a filament of nylon is tied with a loop 38' intermediate its free ends 39-39'. The end 39 is threaded through all foot apertures 37 before passing through loop 38' and is then tightened, to radially inwardly compliantly draw all foot ends 37 to within the peripheral confines of lens 30, as denoted by phantom outlines 3~' in Figure 12. In operative insertion of the retracted legs 36 past the pupil, the suture ends 39-39' are held back, the end 39 being tightly held until release when legs 36 are safely behind the iris. Upon release of the end 39, the other end 39' is drawn, thereby first withdrawing the loop 38' and allowing the remaining end 39 to pull out of loop 38' and all apertures 37 before complete removal of the suture.
Figures 13 and 14 depict another lens mount embodiment of the in-~ention wherein ~he ring-like body comprises plural spaced arcuate spans 40-41-42 between integrally connected loops 43~ and wherein at each loop a short bridge 44 ~at a radial offset ~ r, with respect to the circle of body arcs 40-41-42, in the blank of Figure 13) connects the spaced legs of the loop and circumferentially strcngthens the circumferential integrity of the body. Radially inwardly extending from each bridge 44 is a lens-retaining formation 45, effectiYely isolated from the associated bridge 44 except for arcuately spaced integral leg connections 46 thereto. The rod-like feet 47 of previously described embodiments radiate centrally from each of the body arcs 4~-41-42.

3'~5~

The blank of Figure 13 is bent by suitable tooling into the lens-retaining configuration shown in Figure 14 J wherein it is seen that the pro-jections 45 have been axially offset from the plane of body arcs ~0-~ 2, so that the respective axial limits of the periphery of the lens element (sug-gested by phantom outline ~8) are engaged to permanently retain the lens to its mount. The relatively substantial radial extent ~ r' by which bridge ~4 is connected to the legs of each loop ~3, in the context of the relatively torsionally compliant nakure of connection of each loop 43 to its adjacent body arc (40-41-42) will be understood to enable transient radially outward manipulation of any of the lens-engaging projections 45 merely by axially de-flecting one of the loops 43, thus readily permitting insertion of and engage-ment to a lens 48 at its rim.
To complete the description of Figure 14, the loops 43 will be seen to have been subjected to bending, such that each bridge element 44 extends axially to provide an axial offset for the radial plane of loops 43 with res-pect -to the radial plane of feet 48, so that loops 43 and feet ~7 may engage opposite sides of a supporting iris.
~lso shown in Figures 13 and 1~ is the provision of a singularly wide body-arc element at 42, for identification purposes, e.g., manufacturer's mark, lens-identifying code, and date of manufacture.
Thus far, the invention has been described in the particular context of using a metal as the material of the lens-mounting structure. This is not to be taken as precluding the use of other materials, as for example a suit-ably inert plastic, SUC}l as nylon or polypropylene. In a preferred employment of a Eilm sheet of nylon or a high-temperature polyimide (e.g., Kapton*, a product of E. I. DuPont Companyj, very much the same etching technique may be employed as above indicated for the case of an etched sheet of metal. This close similarity will appear from the following Example I, being a specific recital of s-teps to produce the plastic article.

* trade mark 3'~

EXAMPLE I
1. A sheet of nylon or polyimide film is selected, 0.002 to 0.005-inch thick, being the same thickness range as used in the etched-metal tech-nique described above. The selected plastic sheet is tested ~or water con-tent, mechanical strength, and spectrographically ~or fidelity of composition.

2. The sheet is washed in acetone and is then air-dried.

3. The sheet is washed in distilled water and is then air-dried.
~ . The sheet is visually inspected for cleanliness and surface defects.
5. The sheet is prepared for a photo-resist coating by vacuum or other deposition of chromium.
6. A photo-resist coating of photographic emulsion is applied to both sides of ~he sheet and is then allowed to air-dry.
7. ~y first preparing a drawing at 20X to 50X scale, and then pho-tographically reducing it, in steps as necessary, culminating in reproduc-tion onto a glass photographic plate, a master negative is made to ultimate-ly desired scale; preferably, the master negative includes a plurality of duplicates of the same photographically reduced drawing, in side-by-side ad-jacency and with interconnected leg formationsJ as will appear for the ~angential rod-like connections 50 to legs of the configuration repeated in Figure 15.
8. The nylon or polyimide film sheet is p]aced in a vacuum frame to flatten and hold it tight agains~ a glass platten, and the master negative is photographically exposed to both sides of the sheet, with accurate registry.
9. The exposed sheet is developed, with the result that areas are not developed where masked by the negative and, thereforeg not exposed to light. The areas reached by light are washed away by ~he developer, and in the case of polyimide sheet, the*e may be an initial etching action attri-butable to the developer.

- _g_ 3 ~3~7~i 10. The developed sheet is fixed.
11. The sheet is etched, hydrazine hydride being used for the etch-ing of nylon or polyimide sheet, and being usable for certain other p]astic materials.
12. Tile photo-resist is washed away, using either a plasma process or a fluorocarbon cleaner.
13. The resulting lens-mount sheet of severably connected part blanks is then dipped in a 30 percent solution of hydrazine hydride, to round-oEf edges of the parts.
14. The sheet of otherwise-finished parts is degassed, by increasing sheet temparature to 300F. in the case of nylon~ or 500F. for the case of high-temperature polyimide.
15. The mounting rings are cut free from the sheet, at 50, to cre-ate individual ring blank parts, as in Figure 13.
16. Individual ring parts are mechanically bent to profile, as appears in Figure 14, and the profile is inspected.
17. A glass or molded-plastic lens is selected and mounted, as appears from the phc~ntom-outline relation in Figure 14.
18. The total assembly is inspected, and the assembly is marked, with serial number and code, at 42 in Figure 1~.
19. Final inspection is performed.
20. The total individual assembly is plasma-cleaned and packaged, and then gas or autoclave-sterilized.
21. Final inspection is performed through the package window, and the package is marked, as to date and lot.
A totally diferent photo-etch or other erosion technique is also applicable to manufacture of lens-mounting adapters of the present character, particularly for the case of such adapters formed rom plastic sheet, as will appear from the following ~xample II.

3~

EXAMPLE II
1. Two matching metal masks or master sheets, for example of alum-inum, are prepared as in accordance with the photo-etch technique described at page 4 above.
2. A sheet of suitable plastic, such as nylon or polyiilide film, is selected, 0.002 to 0.005-inch thick, and is subjected to testsJ washing and drying as noted at steps l to 4 of Example I.
3. The metal master sheets are cement-laminated to the front and back surfaces of ~he plastic sheet, in precise register.

4. The plastic-sheet laminate, thus masked, is exposed to the dis-charge of a plasma genera*or or micro-ion mill, in the presence of a suitable reactive gas, for e~ample for one hour, until the desired configuration has been generated by erosion of unmasked regions of the plastic material.

5. The cement is dissolved to permit removal of the aluminum masks or master sheets for cleaning and re-use.

6. ~he configurated plastic sheet has the appearance of Figure 15 and may be cleaned by further exposure as in Step No. 4 of this Example II, for examp~e for an exposure time of approximately two minutes~ *o remove any ; possible organic debris and burrs.
It will be seen that I have described intra-ocular lens and mount structures meeting all s~ated objects, and, importantly, lending themselves to mass-production techniques, of inherent precision and control. The drill-ing operations previously considered necessary have been totally avoided, as has also the reliance upon multiple parts, thus simplifying manufacturing and avoiding generation of waste particles. While plastic lenses have been speci-fically mentioned in several illustrative contents, it will be appreciated that the invention is not necessarily limited to such use. For example, glass lenses are to be preferred and certainly can be well and safely mounted, using structures of Figures 11 to 14. Also, although circular lens body-ring peri-~0 pheral con~ours have been described for all forms, it will be appreciated ~3~

that this was purely to simplify description7 in that the described tech-niques and structure have equal application whatever the peripheral contour of the lens; for example, an oval lens-rim contour may be selected for more ready operative insertion past the pupil, for certain patient requirements~
and to reduce the chance of surgical trauma. Still further~ ~he inherent nature of the mounted lenses of the invention is such that an absolute mini-mum of structure ever protrudes into the anterior chamber of the eye; thus, danger of corneal-tissue contact with any part of the intra-ocular lerls struc-ture of the invention is substantially less than that with prior art structures.
For the disclosed forms of the invention wherein the iris closes on a cir-cular lens periphery, there is minimal stress on the sphincter muscle, with attendant reduced risk of trauma.
In the discussion thus far, it has been indicated that the lens ele-ment accommodated by my mounting-ring adapter may be of glass or plastic ma-terial, the implication being that the lens element is a separate article of manufacture, later assembled to its mount. However, it will be appreciated that every one of the described mounting-ring embodiments is applicable to placement in a suitably formed lens-molding cavity such that at least the lens-retaining part of the mounting ring is embedded in a plastic lens ele-ment that is injection-molded in the cavity. The blank of Figure 13 lends itself particularly well to such use at the time of injection-molding the lens element, in that the lens-retaining extension 45 need not be bent radially, as shown in Figure 14, but rather may merely be bent axially, as shown at 45' in ~igure 14A, in which case injection-molding lens material may be forced in the molding process to enter the slot or opening 49 between bridge 44 and ex-tension 45. Thus-molded, the lens element will be positively keyed and lo-cated by radially outwardly formed iens material at each of the openings 49.
It has also been indicated above that the preferred process of etch-ing developed regions of a photographically reduced lens-mount master negative lends itself to quantity production of pluralities of such lens mounts, in '7~i adjacent multiple as suggested in Figure 15. And such production lends it-self to further options in regard to assembly with plastic lens elements. In one procedure, the individual mounting blanks are severed at 50 and are then bent to form lens- retaining projections, as described at ~5' in connection with Figure 14A; the individual moullt, thus-prepared, may then be assembled to the lens-moldiIlg cavity for localized embedding in the lens material in the course of injection molding the lens. Alternatively, the lens-retaining pro~
jections 45' may be bent out o:E all lens-mount structures in a large plurality on a single sheet, prior to severance at 50; in that event, and with the sheet of thus-formed lens mounts suitably ir.troduced to a multiple-cavity mold for simultaneously molding a similarly spaced plurality of iens elements, all of the plural lens-and-mount assemblies may be completed in a single in-jection-molding step7 i.e., a single injection-molding of all lens elements, each into assembled relation with its own mount. ~hus formed, the plural assemblies are conveniently handled, shipped and stored as a single sheet, with severance of individual assemblies at 50, only when and as needed.
I~lile the invention has been described in detail for the preferred forms shown, it will be understood that modifications may be made within the scope of the invention. For example, the reference to metal for the adapter structures of Figures 11 and 12 will be understood to be illustrative, since similarly formed and suitably stiff and non-toxic plastics may also serve the same purpose. Also, the reference to photo-chemical preparation of metal "blanksl' is illustrative of a preferred technique, in that photo-resist and plating techniques of the printed-circuit teshnology, with subsequent release from a substrate, may also be employed; and the use of positive and negative terminology in reference to photographic processing will be understood to be illustrative and not limiting, in that reversal development techniques for proceeding from positive original, directly to a positive-developed image, are also to be understood as applicable.
Also, while metal-ring structures have been disclosed in combination with the lens element thereby mounted, it will be understood that such uni-tary structures may be, and in certain cases preferably are, subjected to an inert protective coating of a plastic material such as nylon, thus assuring against any possibility of a minute metal burr or barb projecting for body-tissue contact. By the same token, the described plastic~sheet embodiments and methods will be understood to relate to basic structural ~ormations and not necessarily to be concerned with such final coating or finishing as may be desired for particular purposes, for example, a coating of inert material, such as vacuum-deposited or sputtered Teflon or platinum may be applied to an otherwise-finished configurated adapter element, to provide enhanced assurance of a non-toxic ultimate product.
Still further, it will be understood that although all mounting adapters thus far described have been of single-piece unitary construction, the described methods of manufacture are also applicable to multiple piece mounting adapters, such as the two-piece configurations disclosed in greater detail in my patent applica$ion ~A~$orney Docket No. 737) filed on even date herewith. The basic blank element, i.e., for one half of such structure, is shown at 60, in solid outline in Figure 16, with its two mounting lobes 61 projecting radially outward of its ring-like body 62, a-t diametrically op-posed locations; another such element 63 is shown in phantom outline with its two mounting lobes 64 in angularly interlaced relation with lobes 61. The lobes ~61) of one adapter element (60) and the lobes (64) of the other ad-apter element (63) are retained in slotted interlobe regions 65-65' of the respective elements 60-63, and the thus-assembled adapter elements uniquely locate and retain a lens 66; when inserted in the eye, the lobes 61 stabilize the assembly with reference to one side of the iris, and the lobes 64 provide stability with reference to the other side of the iris. The nature of the ma~erial of the elements 60-63 should be such that at least $he lobes to be inserted past the iris are resiliently compliant, and highly satisfactory assemblies may be made wherein both adapter elements 60-63 are duplicates of each other, formed of suitable plastic such as nylon or polyimide sheet, according to methods as described above at Example I and Example II. Thus 3~S~i a single mul~iple-element sheet, a fragment of which is shown in Figure 17, may be preparecl to serve the mounting-adapter element (60-63) purposes of a plurality of Figure 16 assemblies. It is to be understood, furthermore, that chemical e~ching and mechanical, electronic or other erosion are to be deemed equivalent manipula.tive s-teps, depending upon the manufacturing ap-proach and selected materials involved.

Claims

Claim 1. As an article of manufacture, an optically finished intra-ocular lens element of plastic material and having a generally circular periphery about its optical axis, and a single-piece weld-free metal mounting adapter therefor, said adapter comprising a circumferentially con-tinuous ring body which is centrally open and which is in substantial conformance with and in registering adjacency to the periphery of said lens element, plural angularly spaced anchoring elements integral with said ring body and projecting within and united to adjacent local peripheral regions of said lens element, and first and second pluralities of lens-positioning feet integral with said ring body and radially outwardly extending therefrom in angularly spaced and inter-laced relation, the feet of one plurality being in axially offset relation to the feet of the other plurality.
2. The article of claim 1, wherein said anchoring elements are rod-like projections in axially directed imbedded relation to said adjacent local peripheral regions of said lens element.
3. The article of claim 1, wherein said anchoring elements are rod-like projections in radially directed imbedded relation to said adjacent local peripheral regions of said lens element.
4. The article of claim 1, wherein said ring body and said lens element are in axially abutting adjacency.
5. The article of claim 1, wherein said ring body and said lens element are in radially abutting adjacency.
6. The article of claim 1, wherein the feet of one of said pluralities are filamentary lobes with at least one end of each lobe integrally united to said ring body.
7. The article of claim 1, wherein the feet of one of said pluralities are filamentary lobes with both ends of each lobe integrally united to said ring body.
Claim 8. As an article of manufacture, a single-piece weld-free mounting adapter for iris-stabilized mounting of an intra-ocular lens element, comprising a circumferentially continuous ring body which is centrally open and which is of peripheral contour generally conforming to the peripheral contour of the lens element, plural inwardly extending angularly spaced anchoring elements integral with said ring body for engagement with spaced local peripheral regions of the lens, and first and second pluralities of lens-positioning feet integral with said ring body and radially outwardly extending therefrom in angularly spaced and interlaced relation, the feet of one plurality being in axially offset relation to the feet of the other plurality.
9. The article of claim 8, wherein said anchoring elements are rod-like projections having axially directed ends for axially directed anchorage to said lens regions.
10. The article of claim 8, wherein said anchoring elemen are rod-like projections having radially directed ends for radially directed axially retaining engagement with said lens legions.
11. The article of claim 8, wherein the feet of one of said pluralities are filamentary lobes with at least one end of each lobe integrally united to said ring body.
12. The article of claim 11, wherein the feet of one of said pluralities are filamentary lobes with both ends of each lobe integrally united to said ring body.
Claim 13. As an article of manufacture, a single-piece unitary metal mounting adapter for iris-stabilized mounting of an intra-ocular lens element, comprising a circumferentially continuous ring body of peripheral contour generally conforming to the peripheral contour of the lens element, plural inwardly extending angularly spaced anchoring elements integral with said ring body for engagement with spaced local peripheral regions of the lens, and first and second pluralities of lens-positioning feet integral with said ring body and radially outwardly extending therefrom in angularly spaced and interlaced relation, the feet of one plurality being in axially offset relation to the feet of the other plurality, the projecting ends of the feet of said one plurality having compliantly bendable integral connection to said ring body, whereby each of the feet of said one plurality may be resiliently stressed and inwardly deformed at reduced radial offset from the ring-body axis in the course of insertion via an iris opening, and further whereby such a deformed foot may thereafter be released -for compliant restoration of its unstressed radially outward orientation behind the iris opening.
Claim 14. As an article of manufacture, an optically finished intra-ocular lens element having a continuous periphery about its optical axis, and a single-piece weld-free integrally formed mounting adapter therefor, said adapter comprising a peripherally continuous ring body which is centrallv open and which is in retaining assembly to peripheral regions of said lens element, and first and second pluralities of lens-positioning feet integral with said ring body and radially outwardly extending therefrom in angularly spaced and interlaced relation, the feet of one plurality being in axially offset relation to the feet of the other plurality.
claim 15. As an article of manufacture, an optically finished intra-ocular lens element of a relatively rigid first material and having a continuous periphery about its optical axis, and a single-piece integrally formed weld-free and ring-like mounting adapter therefor, said adapter comprising a peripherally extending body of a relatively bendable second material, said adapter having a central opening and being in retaining assembly to peripheral regions of said lens element, and first and second pluralities of lens-positioning feet integral with said ring body and radially outwardly extending therefrom in angularly spaced and interlaced relation, the feet of one plurality being in axially offset relation to the feet of the other plurality.
16. The article of claim 15, in which said body is relatively stiffly compliant, and of finite circum-ferential extend substantially exceeding 180 degrees about a central axis through the general plane of said body.
17. The article of claim 15, in which said body is relatively stiffly compliant, and comprises plural angularly spaced arcuate portions integrally interconnected by radially outward compliant bows defining at least one of said pluralities of lens-positioning feet.
Claim 18. As an article of manufacture, an optically finished intra-ocular lens element having a continuous periphery about its optical axis, and a single-piece integrally formed weld-free ring-like mounting adapter therefor, said adapter being centrally open and having compliant lens-engaging means for axially retaining peripheral engagement with said lens element, and said adapter further comprising first and second pluralities of lens-positioning feet integral with said ring body and radially outwardly extending therefrom in angularly spaced and interlaced relation, the feet of one plurality being in axially offset relation to the feet of the other plurality.
19. The article of claim 18 in which said mounting adapter is of single-piece metal construction.
20. The article of claim 18 in which said mounting adapter is of single-piece plastic construction.
21. The article of claim 14, in which said lens element is of glass.
22. The article of claim 14, in which said lens element is of methylmethacrylate.
23. The article of claim 14, in which said lens element is of phototropic material.
24. As an article of manufacture, an optically finished intraocular glass lens element having a continuous periphery about its optical axis, and a single-piece weld free integrally formed mounting adapter therefor, said adapter comprising a centrally open body in one axial side of said lens element and conforming generally to the periphery of said lens element and in retaining assembly to peripheral regions of said lens element, said adapter including plural radially directed barbs at angularly spaced locations on said body, at least same of said barbs extending axially over adjacent peripheral regions of said lens element and radially inwardly engaging over the side of said lens element offset from said body, and first and second pluralities of angularly spaced lens-positioning feet extending radially outwardly from said body, the feet of one plurality being axially offset from those of the second plurality.
25. The article of claim 26, in which said first and second pluralities of feet are in offset relation corres-ponding generally to the sides of said lens element, whereby upon assembly to an iris, the iris is supported by the periphery of said lens elements.
26. The article of claim 8, wherein said anchoring elements are rod-like projections having radially directed ends and wherein some of said radially directed ends are axially offset with respect to other of said radially directed ends for axial-retaining opposite-side engagement with the periphery of a lens element.
27. As an article of manufacture, a single-piece unitary metal mounting adapter for iris-stabilized mounting of an intraocular lens element, comprising a circumferentially continuous ring body of peripheral contour generally conforming to the peripheral contour of the lens element, plural inwaardly extending angularly spaced anchoring elements integral with said ring body for engagement with spaced local peripheral regions of the lens, and first and second pluralities of lens-positioning feet integral with said ring body and radially outwardly extending therefrom in angularly spaced and interlaced relation, the feet of one plurality being in axially offset relation to the feet of the other plurality, the feet of one of said pluralities being filamentary lobes with at least one end of each lobe integrally united to said ring body, the feet of said one plurality having compliantly bendable integral connection to said ring body, whereby each of the feet of said one plurality may be resiliently stresssed and inwardly deformed at reduced radial offset from the ring-body axis in the course of insertion via an iris opening, the other end being apertured for passage of a control filament therethrough, whereby such a foot may be deformed by filamentary control and released for compliant restoration of its unstressed radially outward orientation behind the iris opening.
28. As an article of manufacture, a single-piece unitary mounting adapter for iris-stabilized mounting of an intra-ocular lens element, comprising a circum-ferentially continuous ring body of peripheral contour generally conforming to the peripheral contour of the lens element, plural inwardly extending angularly spaced anchoring elements integral with said ring body for engage-ment with spaced local peripheral regions of the lens, and first and second pluralities of lens-positioning means integral with said ring body and radially outwardly ex-tending therefrom in angularly spaced and interlaced relation, the positioning means of one plurality being in axially offset relation to the positioning means of the other plurality, the projecting ends of the positioning means of said one plurality having resiliently compliant bendable integral connection to said ring body, wherebv insertion via an iris opening may be aided through such bending of at least one resilient connection.
29. The article of claim 3, wherein said ring body is axially offset with respect to the general plane of radial imbedment of said rod-like projections.