METHOD AND APPARATUS FOR HOLDING AND FOLDING DEFORMABLE ELASTIC INTRAOCULAR LENSES

Abstract: A device for folding an intraocular lens (IOL) and thereafter holding it in its folding state, optionally in combination with a case for holding the device comprises a member (1) foldable into two sections (10, 12) which may be of substantially equally dimensions, each of said sections having a shoulder portion (24) formed in a slot (20) between each section and dimensioned to receive an edge of the optic of an unfolded IOL (18) and to hold the IOL in the plane of the member when the member is in an unfolded state.

Description: This invention relates to a device for folding an intraocular lens (IOL) and thereafter holding it in its folded state and to a method of folding a foldable IOL utilising such a device. In order to reduce to a minimum, the size of the incision through which IOLs are inserted during surgical implantation, the use of deformable elastic IOLs has been proposed. An improved form of such an IOL and a tool for folding and inserting such an IOL are described in United States Patent No. 4834750. Other apparatus and devices for folding IOLs are described in US Patent Nos.; 4573998; 4681102; 4715373; 4747404;p 4759359; 4769034; and 4819631. Several of such devices included forceps for folding in half and holding deformable elastic IOLs for insertion into an eye during IOL implant surgery. In order to fold such an IOL, commercially available forceps include large parallel tongs for gripping and folding the IOL. To have the strength necessary to fold an IOL body, the tongs of such forceps are relatively bulky. Other forceps having smaller and more delicate gripping tongs do not have sufficient strength to fold most deformable elastic IOLs. Further, in practice it is very difficult to accurately fold an IOL along its diameter to reduce to a minimum the size of the folded IOL. Accordingly, there is a need for an apparatus and method to simply and more accurately fold IOLs along their diameters and for holding such folded IOLs so that they can be gripped by small and delicate forceps which may be efficiently inserted through incisions of the smallest possible size during IOL implant surgery. The devices and methods of the present invention satisfy such needs. The present invention provides a device for folding an intraocular lens and thereafter holding it in its folded state which device comprises a member foldable into two sections along a hinge line and a slot in the member between the sections along and symmetrically disposed along a portion of the hinge line and wherein the slot has relieved edge portions defining opposing shoulders for receiving opposed edges of the optic of an intraocular lens and to hold the intraocular lens in the plane of the member when the member is in an unfolded state. Each of the two sections may be of substantially equal dimensions in the plane of the member when the member is in an unfolded state. The slot may extend beyond the shoulder portions. The relieved edges in the sides of the slot may be portions or protrusions from the side wall extending into the cavity of the slot. These protrusions may be ear shaped. The shoulder portions may be of any suitable geometrical configuration, for example, semicircular, triangular or rectangular. According to a further embodiment of the present invention, the slot of the device of the present invention begins at the outer edge of the member and extends beyond the shoulders. According to a further embodiment of the present invention the slot is disposed about the area of the shoulders so that the shoulders are centrally disposed within the slot. The sections of the member may be beveled along the fold line of the member to facilitate folding of the member. The beveled portion of each section may be on the side which lies on the outside of said device when the device is in a folded state. The device according to the present invention may also include means for locking the device in the folded position. The device may be made of any suitable material such as moulded or milled plastics material. The material for the case should be capable of withstanding any sterilisation procedures required for the IOL. The present invention also provides, in combination, a device in accordance with the invention together with a case which is suitable for transporting or shipping the device having an IOL contained therein which is either in a substantially flat ie. unfolded configuration, or is folded. The case may suitably be of a plastics material. In one form the case is adapted to hold the device containing the folded IOL and comprises a base for supporting the device and a top secured to the base in a foldable manner, and means for securing the device in the case whereby in use the top folds over, covers and secures the folded IOL. The means for securing the device may comprise one or more protrusions extending from the case top and/or bottom which are received into recesses in the device, when the case is closed. The combination may also comprise a second or further intraocular lens stabilising means attached to the top or bottom of the case for securing the intraocular lens in the device when the top of the case is folded over the base. The case may thus further comprises IOL stabilising means for example protrusions extending from the base or the lid of the case through the slot in the device adjacent the IOL. Where the device is secured in the case in an unfolded condition, a pair of protrusions may extend through the slot either side of the lens optic. The optic is then secured against movement in one direction by the shoulders of the slot and against movement in the transverse direction by the protrusions. Aptly the faces of the protrusions adjacent the optic will be profiled to provide a close fit to the optic's circumference. The case may also be provided with suitably shaped portions extending from the top and or bottom of the case to prevent movement of the lens optic upwardly or downwards in the case. These extensions may be in the form of bosses, the tens facing surfaces of which are preferably profiled to correspond to a major surface of the optic. For example, the boss adjacent to convex surface of the optic may have a concave surface. The case may further be provided with protrusions which extend from the top and/or bottom of the case, and, in use extend through or co-operate with recesses or openings formed in the device to releasably secure the device in the case until it is desired to remove it. The device of the present invention may also be placed in a case suitable for transporting the device having an unfolded IOL therein which case has a recess formed therein for receiving the device with the IOL therein, the recess being configured to enable a portion of the device to be gripped until it is desired to remove it. The device may be held within the case either by a friction fit between the device and the surface of the recess in the case, or by means of a release member which is capable of locking the device within the recess and releasing it when desired. In this latter form the case is provided with arm moveably secured to the underside thereof, which arm is provided with protrusion which engages with a recess formed in the device. When the device is pushed into the recess in the case and the arm is moved into a locking engagement whereby the protrusion on the arm engages the recess in the device the device is held within the recess. The arm may also be provided with a second protrusion which is adapted to move and fit into a slot formed in and extending through the body of the case. The arm may be moved into or out of locking engagement with the device by moving the second protrusion into or out of the slot in the case. The present invention also includes a method of folding a foldable IOL along a diameter thereof which comprises placing an IOL in any of the embodiments of the above described device so that the edges of the optic rest on the shoulders and the optic is substantially centred along the fold line of the member, and folding the sections together. The invention will be further described with reference to the accompanying drawings in which: Fig. 1 is a perspective view of a first embodiment of the device of the present invention in an unfolded condition holding an IOL. Fig. 2 is a perspective view of the device of Fig. 1 in a folded condition with forceps gripping the folded IOL for removal from the device. Fig. 3 is an enlarged perspective view of an second embodiment of the present invention in an unfolded condition. Fig. 4 is an enlarged perspective view of the device of Fig. 3 in a folded condition. Fig. 5 is an enlarged perspective view of the device of Fig. 4 with an IOL folded along a diameter thereof and forceps gripping the folded IOL for removal from the device. Fig. 6 is a top view of the device of Fig. 3 in an open shipping case. Fig. 7 is section side view of the device and shipping case shown in Fig. 6. Fig. 8 is an enlarged side sectional view of a portion of the device and shipping case combination shown in Fig. 7 illustrating the manner in which an IOL is supported in its flat or unfolded form within the combination. Fig. 9 is an enlarged top view of a further embodiment of the present invention holding an IOL with two loops or haptics and having means for locking the device in the folded position. Fig. 10 is a section taken along lines 10/10 of Fig. 9. Fig. 11 shows the device of Fig. 9 in a folded state. Fig. 12 is a sectional view taken along lines 12/12 of Fig. 11. Fig. 13 is a sectional view taken along lines 13/13 of Fig. 12. Fig. 14 shows the embodiment of Figs. 9 to 13 in a case suitable for transporting the device with an IOL in the unfolded state. Fig. 15 is a section taken along lines 15/15 of Fig. 14. Fig. 16 is a section taken along lines 16/16 of Fig. 14. Fig. 17 is a section taken along lines 17/17 of Fig. 14. Fig. 18 is an enlarged partial view of the device in a case where the device is held by a friction fit. Fig. 19 is a section taken along lines 19/19 of Fig. 18. Fig. 20 shows a further embodiment of the device of the present invention. Fig. 21 shows a further embodiment of the case of the present invention for receiving the device of the present invention with an IOL is an unfolded state. Fig. 22 shows a device according to the present invention fitted within the case of Fig. 21. Fig. 23 is a section along lines 23/23 of Fig. 22. As shown in Figs. 1 and 2, the device of the present invention comprises a member 1 foldable into two sections 10 and 12 of substantially equal dimensions, along a hinge line 16 joining the sections of the member. The foldable member 1 is made of any suitable foldable material such as moulded or milled plastic. Hinge means 14 can, for example, be a hinge line formed along a bevelled portion of each section of said member 1. The section portions are substantially coplanar when the device is in an unfolded condition to receive IOL 18 as illustrated in Fig. 1. The hinge means 14 is constructed to allow the sections to fold together into a folded condition as illustrated in Fig. 2. Preferably the hinge means 14 is a V-shaped channel in a bottom surface of the member leaving a narrow strip of material along the hinge line 16 joining the sections. In the embodiment of the invention shown in Figs. 1 and 2, the device includes a slot 20 in and between the sections 10 and 12 along and symmetrical relative to the hinge line 16. According to this embodiment the slot is open at one side of the sections 10 and 12 and has relieved upper edge portions defining opposing semicircular shoulders 22 and 24. The shoulders are shaped to receive and support opposing edge portions of the IOL optic or lens body 18 and to hold the optic in the plane of the sections when the device is in its unfolded condition. The shoulder may be of any convenient geometrical configuration. While they are shown here as semicircular, they can also be triangular or rectangular. The slot 20 also extends along the hinge line 16 on either side of the shoulders to receive haptics 18a and 18b extending from the IOL optic when it is supported by the shoulders. The shoulders support the IOL optic 18 such that the major axis or a diameter thereof lies along or is directly over the hinge line 16. Thus supported, when the device is folded as shown in Fig. 2, the IOL optic folds simply and accurately above the hinge line and on the major axis or diameter. The folded IOL then may be gripped, for example, by the tongs of a small and delicate forceps 26 for removal from the device as shown in Fig. 2. A second embodiment of the device of the present invention is shown in Figs. 3, 4 and 5. According to that embodiment of the device, slot 20¹ rather than being open ended as was slot 20 in Figs. 1 and 2, extends between opposite end portions 14a and 14b of the hinge means 14. Also, the opposing semicircular shoulders 22 and 24 supporting the IOL optic are formed in ear-shaped portions or protrusions of the inner edges of the slot 20¹. In addition, the sections 10 and 12 include openings 28 and 30 (for receiving positioning tabs 32 extending from a case 34 for the device such as the one illustrated in Fig. 6). In Fig. 6, case 34 is preferably formed of a single piece of material such as plastic, and includes a flat base 36 having vertically extending side rails 38 for supporting sections 10 and 12 of the device in its unfolded condition. Flat top 40 is hinged at 42 to the base to fold over, cover and secure the IOL 18 held in the device. In this regard, as shown most clearly in Figs. 6, 7 and 8 vertical stabilising tabs 44 and 46 extend upward from base 36 through the slot 20¹ immediately adjacent edges of the IOL optic to combine with shoulders 22 and 24 to provide lateral positioning for the IOL 18. In addition, top 40 carries a ring 48 for positioning over the top of the IOL 18 when the top is folded with the bottom to close the case. This provides vertical stability for the IOL in the device of the present invention when mounted in the case. Other cases can be utilised with the device of present invention for shipping the IOL flat in the device of the present invention or folded in the device of the present invention. The device and case combination provides a stable, secure position for the IOL 18 during shipment as well as in storage awaiting use of the IOL in implant surgery. Fig. 9 shows a further embodiment of the device of the present invention which is characterised by having a support for haptics 18a and 18b shown at 18c and 18d. In addition, finger depressions 50 are disposed on the underside of the device to assist in folding the IOL within the device. Protrusion 51 locks into slot or opening 52 so that the device secures the IOL in a folded position. The remainder of the design of device 1 is similar to that described above. Fig. 10 is a section along lines 10/10 of Fig. 9. Fig. 11 shows the device of Figs. 9 and 10 having an IOL with two loops or haptics 18a and 18b folded within the device. Forceps 26 or a similar instrument is shown as gripping the edge of the folded IOL for removal. Fig. 12 is a section taken along lines 12/12 of Fig. 11. Fig. 13 is a section taken along lines 13/13 of Fig. 12. These figures show the finger depressions 50 and the IOL and haptics in the folded position. Figs. 14 to 19 show a further embodiment of the present invention wherein the device is fitted into a carrying or transportation case whereby the device holds an IOL having two loops or haptics 18a and 18b in a folded state. According to this embodiment, the device shown in Fig. 9 slides in a slot 54 in case 53. It is locked in place through arm 56, locking member 57, locking member recess 60 and release member 55 which when the device 1¹ is slid into slot 54 locks the release member into place by movement of member 57 into recess 60. The device 1¹ is released from case 54 by pressing down on release member 55 which moves locking member 57 out of recess 60 as shown in Fig. 15. Case 53 may have a cut-out portion or recess 58 and an eyelit 59. Cut-out or recess 58 is a convenient place to put a trademark or logo. It can also be used as a convenient trough to wash or clean the lens. Figs. 16 and 17 are sections taken along lines 16/16 and 17/17 respectively of Fig. 14. Fig. 18 shows a further embodiment according to the present invention where device 1¹ holding an IOL lens body 18 having haptics or loops 18a and 18b is slid into slot 54, but in this embodiment, device 1¹ is held within slot 54 by a slip or friction fit. Fig. 19 is a section taken along lines 19/19 of Fig. 18 and shows finger depressions 50, protrusion 51 and slot 52 for device 1¹ which locks the device into a folded state. Fig. 20 to 23 show a further embodiment of the present invention where device 1¹ slides into case 53¹ by placement in slot 54¹. The case 53¹ has a curved portion 61¹ which allows the end of device 1¹ having protruberance 51 to extend slightly beyond the end of the slot and is gripable in order to facilitate removable of device 1¹ from slot 54¹. While these figures show a friction fit arrangement, this arrangement is also adaptable to the release member 55, arm 56 locking member 57 and locking member recess 60 shown in Figs. 14 and 15.

Claims: A device for folding an intraocular lens and thereafter holding it in its folded state which device comprises a member (1) foldable into two sections (10,12) along a hinge line (16) and a slot (20) in the member between the sections along and symmetrically disposed along a portion of the hinge line and wherein the slot has relieved edge portions defining opposing shoulders (22,24) for receiving opposed edges of the optic of an intraocular lens and to hold the intraocular lens in the plane of the member when the member is in an unfolded state. A device according to claim 1 wherein each section is of substantially similar dimensions. A device according to claim 1 or claim 2 wherein said slot extends beyond said shoulder portions. A device according to any one of the preceding claims wherein the shoulders are semicircular, triangular or rectangular. A device according to any one of the preceding claims wherein the slot extends from an outer edge of said member to beyond said shoulders. A device according to any one of the preceding claims wherein the sections are beveled along the hinge line of the member. A device according to claim 6 wherein the beveled portion of each section is on the external surface of the device when it is in a folded position. A device according to any one of the preceding claims so that the shoulders are centrally disposed within said slot. A device according to any one of the preceding claims which further comprises means for locking said device in the folded position. A combination of the device according to any one of the preceding claims and a case (34) which is suitable for transporting said device having an intraocular lens either unfolded or folded therein. A combination according to claim 10 wherein said case comprises a base (36) for supporting said member and a top (40) secured to said base in a foldable manner, and means (56) for securing said device in said case, whereby in use said top folds over and covers and secures the folded intraocular lens. The combination according to claim 10 or claim 11 which further comprises a second intraocular lens stabilising means (48) attached to the top or bottom of the case for securing the intraocular lens in the device when the top of the case is folded over the base of the case. A combination according to any one of claims 10 to 12 wherein the case further comprises means for stabilising an intraocular lens said means extending from the base or top of the case through the slot in the device adjacent the intraocular lens. A combination according to claim 12 or 13 wherein the case is provided with extensions in the top or bottom sections which align with recesses or openings in the sections of the device to secure the device in the case. A combination as claimed in claim 14 wherein the top or bottom of the case is provided with a boss which abuts a major surface of the lens optic to prevent movement thereof when the top of the case is folded over the base. A combination as claimed in claim 15 wherein the surface of the boss corresponds to the major surface of the optic. A combination according to any one of claim 10 or claim 11 wherein the case has a recess therein for receiving said device with an intraocular lens contained therein, said slot being configured to enable a portion of said device to be gripped for removal and means for retaining said device within said recess until is is desired to remove it. A combination according to claim 15 wherein said means comprises a friction fit between said device and said recess. a combination according to claim 17 or claim 18 wherein said means comprises an arm (56) movably secured to the underside of said case and having a first protrusion (57) adapted to engage a recess (60) formed in the device thereby securing the device in the case. A combination according to claim 19 wherein said arm is provided with a second protrusion which is adapted to fit movably into and out of a slot formed in said case and permitting the first protrusion to move into or out of locking engagement with the recess formed in said device. A method of folding a foldable intraocular lens along a diameter thereof which comprises placing said intraocular lens in the device of claim 1 so that the edges of the optic rest on the shoulders and the optic is substantially centred along the hinge line of said member, and folding said sections together.

Inventors: BUBOLTZ, DAVID CHARLES, HORNBACK, CHARLES FRANKLIN
Applicants: IOPTEX RESEARCH INC.
Application year: 1990
Main classification: A61F2
IPC codes: A61F2, A61F9