INTRAOCULAR LENS FIXATION DEVICE
20230380959 · 2023-11-30
Assignee
Inventors
Cpc classification
A61F2220/0008
HUMAN NECESSITIES
A61F2/148
HUMAN NECESSITIES
A61F2002/1681
HUMAN NECESSITIES
International classification
Abstract
An ocular clip implant (22) used for securing an intraocular lens (IOL) (62) in an eye of a patient is provided which includes an IOL-engaging portion (26) disposed at a first end of the ocular clip implant (22). The IOL-engaging portion (26) is configured to grasp a portion of the IOL (62). An ocular-wall-engaging portion (28) is integrated with and disposed at a second end of the ocular clip implant (22). The ocular-wall-engaging portion (28) includes an anchor (29) transitionable from a first, straightened configuration to a second, non-straightened configuration to anchor the ocular clip implant (22) to a wall of the eye in order to secure the IOL (62) to the eye. Other embodiments are also described.
Claims
1. An ocular clip implant used for securing an intraocular lens (IOL) in an eye of a patient, the ocular clip implant comprising: an IOL-engaging portion disposed at a first end of the ocular clip implant, the IOL-engaging portion being configured to grasp a portion of the IOL; and an ocular-wall-engaging portion integrated with and disposed at a second end of the ocular clip implant, the ocular-wall-engaging portion comprising an anchor transitionable from a first, straightened configuration to a second, non-straightened configuration to anchor the ocular clip implant to a wall of the eye in order to secure the IOL to the eye.
2. The ocular clip implant according to claim 1, wherein the ocular clip implant comprises a superelastic material.
3. The ocular clip implant according to claim 1, wherein the ocular clip implant is rigid.
4. The ocular clip implant according to claim 1, wherein the anchor has a pointed tip configured to pierce the wall of the eye in order to secure the IOL to the eye.
5. The ocular clip implant according to claim 1, wherein the ocular-wall-engaging portion comprises at least one hook transitionable from the straightened configuration to a curved configuration to anchor the ocular clip implant to the wall of the eye.
6. The ocular clip implant according to claim 1, wherein the ocular-wall-engaging portion is reversibly transitionable from the first, straightened configuration to the second, non-straightened configuration.
7. The ocular clip implant according to claim 6, wherein the ocular-wall-engaging portion comprises a shape-memory material which transitions the ocular-wall-engaging portion from the first, straightened configuration to the second, non-straightened configuration, and wherein the ocular-wall-engaging portion is deformable from the second, non-straightened configuration upon application of a force to the ocular-wall-engaging portion.
8. The ocular clip implant according to claim 7, wherein the ocular-wall-engaging portion is shaped so as to define an opening for reversible coupling of a suture to the ocular-wall-engaging portion, and wherein application of a pulling force to the suture facilitates application of the force to the ocular-wall-engaging portion to deform the ocular-wall-engaging portion from the second configuration.
9. The ocular clip implant according to any one of claims 1-8, wherein the IOL-engaging portion is configured to grasp an optic of the IOL.
10. The ocular clip implant according to any one of claims 1-8, wherein the IOL-engaging portion is configured to grasp a haptic of the IOL.
11. The ocular clip implant according to any one of claims 1-8, wherein the IOL-engaging portion comprises first and second opposing jaws which are moveable with respect to each other to grasp the portion of the IOL, the first jaw being positionable against a first surface of the portion of the IOL at a first location to apply pressure to the first surface of the portion of the IOL, and the second jaw being positionable against a second surface of the portion of the IOL at the first location to apply pressure to the second surface of the portion of the IOL.
12. The ocular clip implant according to claim 11, wherein the ocular-wall-engaging portion comprises a shape-memory material, and wherein each one of the first and second jaws comprise a rigid material.
13. The ocular clip implant according to claim 11, wherein the first and second opposing jaws comprise shape-memory material, and wherein the jaws are configured to assume a closed state in an absence of force applied thereto.
14. A system comprising the ocular clip implant according to any one of claims 1-8, the system further comprising an introduction instrument comprising an introduction sheath configured to house and deliver the ocular clip implant, wherein the ocular clip implant is disposed within the introduction sheath in the first, straightened configuration, and wherein the ocular clip implant is deformable to the second, non-straightened configuration when exposed from within the introduction sheath.
15. The system according to claim 14, wherein the introduction instrument is configured to deliver the ocular clip implant through an entry point in the eye, facilitate grasping of the portion of the IOL by the IOL-engaging portion through the entry point, and facilitate anchoring of the ocular clip implant by the ocular-wall-engaging portion through the entry point.
16. The system according to claim 14, wherein the IOL-engaging portion comprises first and second opposing jaws which are moveable with respect to each other to grasp the portion of the IOL, the first jaw being positionable against a first surface of the portion of the IOL at a first location to apply pressure to the first surface of the portion of the IOL, and the second jaw being positionable against a second surface of the portion of the IOL at the first location to apply pressure to the second surface of the portion of the IOL, and wherein the introduction instrument comprises at least one control shaft reversibly coupled to the ocular clip implant, and wherein the at least one control shaft is moveable to control movement between the first and second opposing jaws.
17. The system according to claim 14, wherein the introduction instrument is reversibly coupled to the ocular-wall-engaging portion, and wherein the introduction instrument is configured to deform the ocular-wall-engaging portion from the second configuration.
18. The system according to claim 17, wherein the introduction instrument comprises at least one suture reversibly coupled to the ocular-wall-engaging portion, and wherein application of a pulling force to the suture facilitates application of the force to the ocular-wall-engaging portion to deform the ocular-wall-engaging portion from the second configuration.
19. A method for securing an intraocular lens (IOL) in an eye of a patient, the method comprising: introducing within the eye through an entry point in the eye an IOL-engaging portion of an ocular clip implant, the IOL-engaging portion disposed at a first end of the ocular clip implant; grasping a portion of the IOL with the IOL-engaging portion; securing the IOL to the eye by anchoring the ocular clip implant to a wall of the eye by: positioning an ocular-wall-engaging portion integrated with and disposed at a second end of the ocular clip implant, partially within the wall of the eye and through the entry point and partially proximally to the wall of the eye; and facilitating transitioning of the ocular-wall-engaging portion from a first, straightened configuration to a second, non-straightened configuration.
20. The method according to claim 19, wherein anchoring the ocular clip implant to the wall of the eye comprises piercing the wall of the eye with an anchor of the ocular-wall-engaging portion.
21. The method according to claim 19, wherein grasping the portion of the IOL comprises grasping an optic of the IOL by the IOL-engaging portion.
22. The method according to claim 19, wherein grasping the portion of the IOL comprises grasping a haptic of the IOL by the IOL-engaging portion.
23. The method according to any one of claims 19-22, wherein grasping the portion of the IOL with the IOL-engaging portion comprises: moving first and second opposing jaws of the IOL-engaging portion with respect to each other, and by the moving: positioning the first jaw being against a first surface of the portion of the IOL at a first location; positioning the second jaw being against a second surface of the portion of the IOL at the first location; and applying pressure to the first and the second surfaces of the portion of the IOL by the first and the second jaws, respectively.
24. The method according to any one of claims 19-22, wherein the method further comprises, subsequently to the grasping, repositioning the IOL within the eye by moving the IOL with the IOL-engaging portion grasped thereto.
25. The method according to claim 24, wherein anchoring the ocular clip implant comprises reversibly anchoring the ocular clip implant by applying a force to the ocular-wall-engaging portion.
26. The method according to claim 25, wherein applying the force to the ocular-wall-engaging portion comprises applying a pulling force to the ocular-wall-engaging portion by pulling a suture reversibly coupled to the ocular-wall-engaging portion.
27. The method according to claim 25, wherein applying the force to the ocular-wall-engaging portion comprises deforming the ocular-wall-engaging portion from the second, non-straightened configuration to the first, straightened configuration.
28. The method according to claim 27, wherein the method further comprises: further repositioning the IOL coupled to IOL-engaging portion the via the entry point subsequently to the deforming the ocular-wall-engaging portion; and subsequently, re-anchoring the ocular clip implant to the wall of the eye by: repositioning the ocular-wall-engaging portion partially within the wall of the eye and through the entry point and partially proximally to the wall of the eye; and facilitating transitioning of the ocular-wall-engaging portion from the first, straightened configuration to the second, non-straightened configuration.
29. The method according to claim 28, wherein introducing the IOL-engaging portion comprises introducing at least a portion of an introduction instrument housing the ocular clip implant through the entry point, wherein further repositioning the IOL comprises using the introduction instrument to move the IOL-engaging portion coupled to the portion of the IOL via the entry point, and wherein re-anchoring the ocular clip implant comprises using the introduction instrument to re-anchor the ocular clip implant via the entry point.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0068]
[0069]
[0070]
[0071]
DETAILED DESCRIPTION OF APPLICATIONS
[0072] Reference is now made to
[0073] Instrument 40 is shown in its assembled state in
[0074] (It is to be noted that in the context of the specification and the claims, the term “clip” means grab or grasp and does not mean cut. The term “ocular clip implant” may also be expressed as “ocular fixation implant.”)
[0075] IOL-engaging portion 26 comprises first and second opposing jaws 25 and 27, which are moveable with respect to each other to grasp or otherwise engage IOL 62, such as an optic 61 of IOL 62, a haptic of IOL 62, or a capsule encapsulating the optic of the IOL. (In the context of the present application, as per common usage in the art, an “IOL” comprises an optic, also known as the lens, and, optionally, one or more haptics for holding the optic in place in the capsular bag inside the eye.) It is to be noted that although system 20 is generally described herein as grasping or being configured to grasp optic 61 of IOL 62, system 20 may also be configured to grasp the haptic(s) of IOL 62, mutatis mutandis. For some applications, IOL-engaging portion 26 grasps or is configured grasp an anchor which may be anchored to any portion of the IOL prior to grasping of the IOL with IOL-engaging portion 26. While
[0076] For some applications, the IOL comprises a plate haptic lens, and IOL-engaging portion 26 grasps or otherwise engages or is configured to engage or otherwise grasp any portion of the plate haptic lens.
[0077] It is to be noted that ocular clip implant 22 comprises jaws 25 and 27 by way of illustration, and that IOL-engaging portion 26 may comprise hooks or loops or any other engaging members.
[0078] First jaw 25 is positionable against a first surface of optic 61 at a first location to apply pressure to the first surface of optic 61. Second jaw 27 is positionable against a second surface of optic 61 at the first location to apply pressure to the second surface of optic 61. For some applications, first and second jaws 25 and 27 have a tendency to close and are configured to assume a closed state in an absence of force applied to jaws 25 and 27 (i.e., in a resting state), and movement between (e.g., the opening of) jaws 25 and 27 is facilitated by an introduction instrument 40 used to deliver ocular clip implant 22, as is described hereinbelow. For some applications, each of jaws 25 and 27 comprises a rigid material, and jaws 25 and 27 are coupled together by a hinge. For some applications, each of jaws 25 and 27 comprises a superelastic material. e.g., nitinol. For some applications, each of jaws 25 and 27 comprises a material having shape-memory, e.g., nitinol. For some applications, jaws 25 and 27 are fabricated from a single piece.
[0079] Typically, implant 22 comprises a biocompatible material. For some applications, implant 22 comprises a superelastic material, e.g., nitinol. For some applications, implant 22 comprises a rigid material. For some applications, implant 22 comprises a metal, e.g., stainless steel, titanium or nitinol.
[0080] Ocular-wall-engaging portion 28 is integrated with ocular clip implant 22 and comprises an anchor 29 that is transitionable from a first, straightened configuration (as shown in
[0081] System 20 comprises an introduction instrument 40, which comprises a device having a handle portion and a distal introduction sheath 42, which houses ocular clip implant 22 during delivery of implant 22 into the eye. Introduction sheath 42 comprises a metal, e.g., stainless steel, titanium or nitinol. Introduction sheath 42 is shaped so as to define a pointed or beveled distal tip 36 that is configured to penetrate the eye in order to facilitate delivery of implant 22 into the eye. Introduction sheath 42 is shaped so as to define a lumen which houses implant 22 in a generally elongated and straightened delivery configuration. Introduction sheath 42 is configured to house and deliver ocular clip implant 22 while ocular clip implant 22 is disposed within introduction sheath 42 in a first, straightened configuration, such as shown in
[0082] As shown by way of illustration and not limitation, jaw 25 comprises two tines and jaw 27 comprises one tine. It is to be noted that each of jaws 25 and 27 may comprise any suitable number of tines. For some applications, jaws 25 and 27 may each comprise a plate (configuration not shown). For some application, jaws 25 and 27 have textured, ridged, or serrated surfaces which increases friction between IOL-engaging portion 26 and optic 61 of IOL 62.
[0083] Alternatively, for some applications, jaws 25 and 27 are elastic and have a tendency to open and are configured to assume an opened state in an absence of force applied to jaws 25 and 27, and movement between (e.g., the closing of) jaws 25 and 27 is controlled by control shafts 44 and 46 to help close jaws 25 and 27. Sheath 42 additionally maintains jaws 25 and 27 in the closed state.
[0084] Typically, introduction instrument 40 controls the opening and closing of jaws 25 and 27 of IOL-engaging portion 26. Implant 22 is shaped so as to define openings 30 and 34 in proximity to jaws 25 and 27. Instrument 40 comprises control shafts 44 and 46 which are reversibly coupled to implant 22 via openings 30 and 34. For some applications, a single shaft combines the functions of shafts 44 and 46. Shaft 44 comprises a hook 41 at a distal end of shaft 44 which engages with opening 34 of implant 22, and shaft 46 comprises a hook 43 which engages with opening 30 (shown in
[0085] For some applications, shafts 44 and 46 are not movable independently of each other, as shown, but rather, shafts 44 and 46 are combined into a single, unitary shaft.
[0086] It is to be noted that the handle of instrument 40 comprises knobs 45 and 47 and shafts 44 and 46 by way of illustration and not limitation. Control of implant 22 may be provided by any mechanism other than knobs 45 and 47 and shafts 44 and 46.
[0087] Reference is now made to
[0088] For applications in which jaws 25 and 27 have a tendency to close, movement of control knobs 45 and 47 facilitate mechanical opening of jaws 25 and 27 so that jaws 25 and 27 may be positioned appropriately with respect to a portion of IOL 62 in a manner in which the portion of IOL 62 is fitted between jaws 25 and 27. Once jaws 25 and 27 are in alignment with IOL 62, jaws 25 and 27 are allowed to close, e.g., by removing forces applied to jaws 25 and 27 and/or by moving knobs 45 and 47 in the opposite direction to the direction knobs 45 and 47 are rotated during opening of jaws 25 and 27. Once IOL-engaging portion 26 assumes the closed state, jaw 25 is positioned against and applies pressure to an upper surface of IOL 62 and jaw 27 is positioned against and applies pressure to a lower surface of IOL 62. In such a manner, IOL-engaging portion 26 of implant 22 functions as forceps, i.e., graspers, which grasp IOL 62.
[0089] Reference is again made to
[0090] As shown in
[0091] Although ocular-wall-engaging portion 28 has a tendency to assume the second, non-straightened configuration in the absence of a force applied thereto, the transitioning of portion 28 from the straightened configuration to a non-straightened configuration is reversible, e.g., by applying a force to portion 28 in order to reshape and deform portion 28 from its second configuration. Ocular-wall-engaging portion 28 is shaped so as to define an opening 32 for passage therethrough of at least one suture 50 to ocular-wall-engaging portion 28. Opening 32 provides reversible coupling of suture 50 to ocular-wall-engaging portion 28. For some applications, a wire is coupled to ocular-wall-engaging portion 28 in place of suture 50. Application of a pulling force to suture 50 facilitates application of the force to ocular-wall-engaging portion 28 to deform ocular-wall-engaging portion 28 from the second configuration into a different shape, e.g., back into the straightened configuration. Suture 50 is looped through opening 32 of ocular-wall-engaging portion 28 and extends through a lumen 52 within instrument 40. Suture 50 is exposed out of a proximal end of instrument 40 such that the physician may apply forces to one or both ends of sutures in order to reshape ocular-wall-engaging portion 28 once ocular-wall-engaging portion 28 is exposed from within introduction sheath 42. Once ocular-wall-engaging portion 28 is appropriately positioned with respect to the native tissue of the eye, suture 50 is decoupled from ocular-wall-engaging portion 28 by pulling on one end of suture 50.
[0092] For some applications, suture 50 comprises a metal, silicone, or plastic suture material, e.g., nylon or prolene. For some applications, system 20 does not comprise suture 50, but rather system 20 comprises a different mechanism or shaft within instrument 40 which applies force to ocular-wall-engaging portion 28 to deform ocular-wall-engaging portion 28.
[0093] Reference is now made to
[0094] System 20 is configured to correct subluxation, or dislocation, of IOL 62. For some applications, system 20 is configured to correct decentration, which may be in any direction such as temporal, nasal, superior or inferior. For some applications, system 20 is configured to correct posterior dislocation of the IOL into the vitreous. In such applications, system 20 is configured to lift the IOL forward from the vitreous into the ciliary sulcus. For some applications, system 20 is configured to correct posterior dislocation of the IOL into the anterior vitreous. For some applications, system 20 is configured to correct dislocation of the IOL during a vitrectomy.
[0095] As shown in
[0096] As shown in
[0097] As described hereinabove, once the distal portions of jaws 25 and 27 are exposed from within sheath, knobs 45 and 47 are rotated so that they press against respective control shafts 44 and 46. Since shafts 44 and 46 are coupled to ocular clip implant 22, as described hereinabove, movement of shafts 44 and 46 applies pressure to and controls movement between jaws 25 and 27. Typically, jaws 25 and 27 have a tendency to close. Movement of shafts 44 and 46 in such embodiments controls opening jaws 25 and 27 such that a negative space is created between jaws 25 and 27 for fitting within the negative space of a portion of optic 61 of IOL 62. For some applications, jaws 25 and 27 instead engage a haptic of IOL 62 or are shaped and configured to engage a haptic of IOL 62.
[0098] As shown in
[0099] For some applications, since jaws 25 and 27 have a tendency to close, the force between jaws 25 and 27 is sufficient to maintain coupling of IOL-engaging portion 26 to optic 61 of IOL 62 in a manner in which implant 22 functions a permanent fixation clip. Alternatively or additionally, jaws 25 and 27 may be further permanently locked in place with respect to IOL 62 by a locking mechanism, e.g., a crimping mechanism or a cinching mechanism. For some applications, a cinch lock is pushed distally from a proximal portion of implant 22, compressing jaws 25 and 27 to close further. The cinch lock may be locked in place, e.g., by engaging a groove on the exterior surface of implant 22. The groove functions as a stopper, preventing the clinch lock from moving beyond the groove. It is to be noted that, for some application, the locking mechanism which locks in place jaws 25 and 27 is engaged after proper positioning of IOL 62 in the appropriate location.
[0100] As shown in
[0101] During the grasping of IOL 62 by IOL-engaging portion 26, anchor 29 of ocular-wall-engaging portion 28 remains in the first, generally-straightened, or straightened, configuration within the lumen of introduction sheath 42, as shown in
[0102] For some applications of the present invention, instrument 40 comprises a safety which prevents premature retraction of sheath 42 and/or deployment of implant 22 from within sheath 42. For some applications, instrument comprises a stop which is operable by the operating physician. For some applications, one or more of knobs 45 and 47 prevents retracting of sheath 42 prematurely and/or prevents premature overexposing of ocular-wall-engaging portion 28 of implant 22 from within sheath 42.
[0103] During grasping and repositioning of IOL 62 as well as retracting of instrument 40 through wall 64 at entry point 60, suture 50 remains coupled ocular-wall-engaging portion 28.
[0104]
[0105] For some applications, anchor 29 may comprise any suitable number of hooks, e.g., two. It is to be noted that anchor 29 may assume any suitable shape. Once transitioned to the second, non-straightened configuration, ocular-wall-engaging portion 28 engages with the wall 64. It is to be noted that ocular-wall-engaging portion 28 may comprise more than one anchor 29, e.g., two or three or any suitable number of anchors 29.
[0106] In all applications of the present invention, ocular-wall-engaging portion 28 provides a suture-less coupling of implant 22 to wall 64 of eye 66 or to the sclera. In other words, ocular clip implant 22, by comprising anchor 29 of ocular-wall-engaging portion 28, is capable of grasping IOL 62 using the forceps feature of IOL-engaging portion 26, facilitate optional repositioning of IOL 62 while grasping IOL 62, and facilitate fixation on IOL 62 after optional repositioning without the need for sutures and/or any additional instruments or any additional entry points into eye 66.
[0107] Once anchor 29 is anchored to wall 64 of eye 66, sheath 42 may be retracted by retracting instrument 40, as shown in
[0108] For some applications, a length of implant 22 is preselected in advance of the repositioning procedure. For some applications, a total length of implant 22 is adjustable in situ using an adjustment mechanism, e.g., a ratchet mechanism, coupled to implant 22. For such applications, for example, IOL-engaging portion 26 and ocular-wall-engaging portion 28 comprise two separate pieces that are coupled together by the adjustment mechanism.
[0109] Anchoring of ocular-wall-engaging portion 28 to wall 64 of the eye prevents tilting, rotating, swiveling, or otherwise displacing of IOL 62 following the repositioning of IOL 62.
[0110] Before instrument 40 is disengaged from implant 22, the operating physician checks to see whether ocular-wall-engaging portion 28 has successfully anchored to wall 64 or to the sclera and checks to see if IOL 62 is properly repositioned. If the physician finds that either IOL 62 or anchor 29 is not appropriately positioned, system 20 provides a mechanism by which anchoring of ocular-wall-engaging portion 28 is reversible so that the physician can either reposition anchor 29 and, if necessary, also further reposition IOL 62 before deploying anchor 29 again.
[0111] Once anchor 29 is deployed, introduction sheath 42 is retracted, as shown in
[0112] As noted hereinabove, during grasping and repositioning of IOL 62 as well as retracting of instrument 40 through wall 64 at entry point 60, suture 50 remains coupled to ocular-wall-engaging portion 28, e.g., by being looped through opening 32 in anchor 29 and by running through a portion of the sclera to outside eye 66. Suture 50 remains coupled to ocular-wall-engaging portion 28 even after deployment of anchor 29. As long as suture 50 remains coupled to ocular-wall-engaging portion 28, the operating physician can deform anchor 29 to a different configuration, e.g., a straightened configuration, by pulling on suture 50 in order to apply pressure to anchor 29, as is described hereinbelow with reference to
[0113] As shown in
[0114] Instrument 40 may then be decoupled from implant 22, as described hereinabove, and instrument 40 is retracted out of the eye. For some applications, even after instrument 40 is decoupled from implant 22, suture 50 remains coupled to ocular-wall-engaging portion 28. Suture 50 is then decoupled from ocular-wall-engaging portion 28 at a later stage.
[0115] For some applications, once ocular-wall-engaging portion 28 has been anchored to wall 64, suture 50 remains coupled to ocular-wall-engaging portion 28 and passes out of entry point 60. In such applications, suture 50 bolsters anchoring of implant 22 by the operating physician using thermal cautery or any other device to melt suture 50 into a flat structure, e.g., a disc, at the sclera such that the flat structure rests against the outer surface of the scleral wall.
[0116]
[0117] Reference is now made to
[0118] As shown in
[0119] Once anchor 29 is straightened, as shown in
[0120]
[0121] Reference is now made to
[0122] Methods for securing and repositioning IOL 68 by grasping haptic(s) 67 using system 120 are similar to those described hereinabove with regard to system 20 with reference to
[0123] Reference is now made to
[0124] It will be appreciated by persons skilled in the art that the present invention is not limited to what has been particularly shown and described hereinabove. Rather, the scope of the present invention includes both combinations and subcombinations of the various features described hereinabove, as well as variations and modifications thereof that are not in the prior art, which would occur to persons skilled in the art upon reading the foregoing description.