Groove fixing frame

Abstract

The invention provides a trench fixing frame. The intraocular assembly comprises a sulcus fixation frame comprising at least one anterior haptic constraining member to which a posterior intraocular device receiving member is coupled by means of a coupling member. The at least one anterior haptic constraining member includes: a groove support portion configured to be received in a groove of an eye; and a haptic support portion configured to block advancement of a haptic of an intraocular device mounted in the groove fixing frame or to fix the IOL in the groove.

Description

Technical Field

[0001] The present invention relates generally to intraocular devices, and in particular to a sulcus fixation frame for supporting an intraocular device. Background Art

[0002] An intraocular lens (IOL) is most often placed in the capsular bag so that the natural bag that holds the human lens now holds the IOL. However, there are situations where IOL implantation in the capsular bag is not an option, such as a lens exchange procedure, where there is insufficient capsular support, the bag is damaged or remnants of the bag interfere with the IOL implantation, or other situations where IOL implantation in the capsular bag is not possible. Other examples of such situations include: subluxation or dislocation of the lens (ectopia lentis) or cases of post-operative aphakia due to intracapsular cataract extraction surgery; or complications of cataract surgery (such as bag dialysis, zonular dialysis, loose zonules, and large posterior capsule rupture); or if an IOL has been previously placed in the bag.

[0003] When implanting the IOL in the capsular bag is not an option, the IOL can be placed in the ciliary sulcus (or simply sulcus), which is the space between the posterior surface of the base of the iris and the anterior surface of the ciliary body.

[0004] For example, the Galileo implantable telescope is designed to correct for problems with focal area defects, such as those caused by, for example, macular degeneration (eg, atrophic or exudative), chorioretinitis of the macula, central serous chorioretinopathy, or ischemia.

[0005] The need for an implantable telescope often arises after a conventional IOL has been implanted. Removing a conventional IOL after several years of use and implanting an implantable telescope in its place is difficult and can be disruptive. Therefore, patients who have undergone cataract surgery and have an IOL in the capsular bag must go through a lens exchange process as described above.

[0006] Placing the haptics of the implantable telescope in the sulcus (like a sutured IOL) is not considered a solution because the implantable telescope is very sensitive to decentration (misalignment with the central optical axis of the eye) and tilt (angular displacement of the focus of the implantable telescope). The tendency for decentration and tilt increases when the IOL is implanted in the sulcus. Therefore, the prior art of placing the implantable telescope in the sulcus does not solve these problems. Summary of the invention

[0007] The present invention seeks to provide a sulcus fixation frame for supporting an intraocular device, as described in detail below. The sulcus fixation frame of the present invention sits securely in the sulcus and minimizes or eliminates any problems with decentration and tilt of the IOL. The sulcus fixation frame constrains the anterior-posterior movement of the IOL. The sulcus fixation frame of the present invention can be used not only to mount an implantable telescope, but can be used to mount any kind of IOL or other intraocular device, such as when capsular bag fixation is not an option.

[0008] According to a non-limiting embodiment of the present invention, an intraocular component is provided, the intraocular component comprising: a groove fixation frame, the groove fixation frame comprising at least one anterior haptic restraint member, a posterior intraocular device receiving member being connected to the anterior haptic restraint member by means of a connecting member, the at least one anterior haptic restraint member comprising: a groove support portion, the groove support portion being configured to be received in the groove of the eye; and a haptic support portion, the haptic support portion being configured to block forward movement of a haptic of the intraocular device mounted in the groove fixation frame. BRIEF DESCRIPTION OF THE DRAWINGS

[0009] The present invention will be more fully understood and appreciated from the following detailed description taken in conjunction with the accompanying drawings, in which:

[0010] Figure 1A is a simplified perspective view of a trench securing frame according to one non-limiting embodiment of the present invention.

[0011] Figure 1B and Figure 1C The sagittal and anterior views of the groove fixation frame are shown, respectively.

[0012] Figure 2A is a perspective view of an initial limbal incision as part of a method for implanting a sulcus fixation framework in accordance with one non-limiting embodiment of the present invention.

[0013] Figure 2B is an anterior view of the limbal incision.

[0014] Figure 2C is a sagittal view of the elevated corneal flap created by the limbal incision.

[0015] Figure 3A is a front view illustration of a sclerotomy incision made at the 6 o'clock (18:00) position using a sclerotomy jig tool having guide holes for making sclerotomies at 10, 2, and 6 o'clock (10:00, 14:00, 18:00) or other segmented positions.

[0016] Figure 3Bis an anterior view illustration of sutures being passed through sclerotomies that have been made at the 10, 2, and 6 o'clock (10:00, 14:00, 18:00) positions and attached to the sulcus fixation frame.

[0017] Figure 3C is a sagittal view illustration of cutting excess suture and using a handheld cautery to create a flange or ball at the end of the suture near the sclera to secure the sulcus fixation frame in the sulcus.

[0018] Figure 3D is an illustration of a sagittal view of a sulcus fixation frame being fixed in the sulcus.

[0019] Figure 3E is a front view of an implantable telescope (in this exemplary case, an IMT - Implantable Micro Telescope) held in a groove fixation frame.

[0020] Figure 3F It is a front view of the groove fixing frame which has been attached to the groove of the eye.

[0021] Figure 3G and Figure 3H Anterior and sagittal views, respectively, of an implantable telescope held in a sulcus fixation frame that has been attached in the sulcus of the eye.

[0022] Figure 4A is a simplified perspective view of a trench securing frame according to another non-limiting embodiment of the present invention.

[0023] Figure 4B and Figure 4C Sagittal and anterior views of the sulcus fixation frame, respectively.

[0024] Figure 4D is FIG. 4A to FIG. 4C Front view of the implantable telescope held in the groove fixation frame.

[0025] Figure 5A is a simplified perspective view of a trench securing frame according to yet another non-limiting embodiment of the present invention.

[0026] Figure 5B and Figure 5C Sagittal and anterior views of the sulcus fixation frame, respectively.

[0027] Figure 5D is FIG. 5A to FIG. 5C Anterior view of an IOL (with rotatable haptics) held in a groove fixation frame.

[0028] Figure 5E It is attached in the groove of the eye. FIG. 5A to FIG. 5CA front view of a sulcus fixation frame is shown, and an IOL is shown ready to be inserted through a scleral tunnel incision (or corneal incision) to be mounted in the sulcus fixation frame.

[0029] Fig. 5F is a front view of an IOL mounted in a sulcus-fixated frame in the eye.

[0030] Figure 5G is a front view illustration of a sclerotomy fixture tool for use with a toric IOL, wherein the tool is used to make a sclerotomy incision for a sulcus fixation frame at a desired dial angle α, which is the desired angular orientation of the astigmatism correction provided by the toric IOL, so that the sulcus fixation frame is pre-dialed to the desired angular orientation of the astigmatism correction.

[0031] Figure 5H is a front view illustration of a toric IOL mounted in a sulcus fixation frame in an eye, showing the toric IOL and its haptics mounted oriented at the desired angle for astigmatism correction, thereby eliminating any need to dial the toric IOL after implantation in the sulcus fixation frame. DETAILED DESCRIPTION

[0032] Reference now Figure 1A , Figure 1B and Figure 1C , which shows a trench fixing frame 10 according to a non-limiting embodiment of the present invention.

[0033] The groove fixation frame 10 may include an anterior haptic restraining member 12 to which a posterior intraocular device receiving member 14 is coupled by means of a coupling member 16. The anterior haptic restraining member 12, the posterior intraocular device receiving member 14, and the coupling member 16 may be made of elongated members of any suitable thickness, such as wires or filaments of any cross-section, circular or non-circular, and may be made of any suitable biocompatible material, such as, but not limited to, nitinol, stainless steel, or other metal or polymer material, whether opaque, translucent, or transparent.

[0034] In the non-limiting embodiment shown, the front haptic restraining member 12 is fixed about the central front-to-back axis 18 ( Figure 1A and Figure 1B ) are symmetrically spaced circumferentially from one another (anterior and posterior being defined as corresponding to the central anterior-posterior axis of the eye to which the frame will be mounted). In the non-limiting embodiment shown, there are three anterior haptic restraining members 12 spaced 120° from one another, but other numbers of anterior haptic restraining members and other spacing orientations (including asymmetric) are also within the scope of the present invention.

[0035] In the non-limiting embodiment shown, each anterior haptic constraint member 12 includes a radially outer circumferential support portion 20 extending between the outer ends 21 of a pair of radial portions 22. A radially inner circumferential support portion 24 extends between the inner ends 23 of each pair of radial portions 22. The radially outer circumferential support portion 20 is also referred to as a groove support portion 20 and is configured to be received in the groove of the eye. The radially inner circumferential support portion 24 is also referred to as a haptic support portion 24 and is configured to block anterior movement of a haptic of an intraocular device, as described below.

[0036] like Figure 1A and Figure 1C As seen in FIG. 1 , the radially outer circumferential support portion 20 is circumferentially longer than the circumferential gap 19 between adjacent radially inner circumferential support portions 24; that is, the circumferential length L20 is greater than the circumferential length L19. In other words, in the sagittal plane, when Figure 3C and Figure 3D When viewed in a sagittal view of , the pair of radial portions 22 are inclined toward each other. The advantage of this structure is that the groove fixing frame is firmly received in the groove, and the intraocular device is firmly installed in the groove fixing frame.

[0037] The posterior intraocular device receiving member 14 may be circular as shown, but may alternatively have other shapes such as, but not limited to, elliptical, polygonal, and irregular shapes.

[0038] Each coupling member 16 may have a front end 26 coupled to the radially outer circumferential support portion 20 and a rear end 28 coupled to the periphery of the posterior intraocular device receiving member 14. The front end 26 may be coupled to the middle of the radially outer circumferential support portion 20. Each radially outer circumferential support portion 20 may include a suture receiving member 30 such as an aperture formed through a tab 32 (alternatively, instead of an aperture, the suture receiving member 30 may be a slit or notch or other suitable structure). The front end 26 may be coupled to the radially outer circumferential support portion 20 near the suture receiving member 30. The tab 32 is a portion of the radially outer circumferential support portion 20 and may protrude radially inward.

[0039] It has surprisingly been found that coupling the leading end 26 to the radially outer circumferential support portion 20 at the suture receiving member 30 provides optimal structural stability for the frame and the intraocular device mounted therein. However, the present invention is not limited to this arrangement, and in certain applications it may be preferred to couple the leading end 26 to a different portion of the radially outer circumferential support portion 20.

[0040] like Figure 1B As seen in FIG. 8 , each link member 16 may have a front straight portion 16AS extending from the front end 26 , followed by a curved portion 16C, and terminated in a rear straight portion 16PS extending to the rear end 28 .

[0041] The present invention is not limited to any size or dimension. The sulcus of the human eye may have a diameter within the range of 11 mm ± 0.4 mm, and thus, the total diameter of the sulcus fixation frame as the outer diameter of the diameter of the anterior haptic restraining member 12 (i.e., the outer edge of the radially outer circumferential support portion 20) may be correspondingly about 11 mm ± 0.4 mm. The diameter of the dilated human iris may be at a maximum value within the range of 7 mm-7.5 mm. Without limitation, an IMT that may be mounted in the sulcus fixation frame may have: an anterior-posterior axial length of 4.4 mm; a central optic having a diameter of 3.6 mm; and a haptic having an outer diameter of 10.8 mm. Thus, without limitation, the diameter of the radially inner circumferential support portion 24 may be 8 mm so as not to visually interfere with the field of view of the eye even when the iris is dilated, and also to block the haptic from moving forward. The diameter of the posterior intraocular device receiving member 14 may be 4 mm-4.2 mm so that the central optic received in the posterior intraocular device receiving member 14 has a radial gap. Note that the outer end 21 and the inner end 23 of the radial portion 22 are also hidden beneath the IMT haptics.

[0042] Reference now Figures 2A to 3H , which shows a method for implanting a sulcus fixation frame 10 into the sulcus. Fixation can be accomplished by sutures fixed to the sclera by any method, but the preferred method is the cuffing method.

[0043] However, the present invention is not limited to this technology, and the ditch fixing frame may be installed in the ditch by other means.

[0044] exist Figure 2A In the embodiment of the present invention, an initial limbal incision 34 may be made with a cutting tool 36 such as a keratome. Figure 2B is a front view of the limbal incision 34 .

[0045] Figure 2C The corneal flap 38 created by the limbal incision 34 is shown raised to create an access opening for the frame.

[0046] Figure 3A A biocompatible marking pen 40 is shown for marking a sclerotomy perforation 42 behind the limbus and piercing into the vitreous space at six o'clock or other segmentation location. A sclerotomy fixture tool 44 may also be used to mark guide sockets 46 that mark all sclerotomies at 4, 8, and 12 o'clock or other segmentation locations. The sclerotomy fixture tool 44 may have an angle scale for showing angles from 0° to 360°. A marking pen 48 may also be used to mark double marks 47 on the sclera that will be substantially parallel to the double marks describing the astigmatism portion on the toric IOL.

[0047] Figure 3B Sutures 50 are shown being passed through sclerotomy incisions 42 that have been made at 10, 2, and 6 o'clock (10:00, 14:00, 18:00). Sutures 50 are coupled to the sulcus fixation frame 10 at suture receiving members 30. Sutures 50 may be manipulated by forceps (also known as forceps) 52. Sutures 50 may be made of nylon or polypropylene (such as PROLENE sutures) or any other suitable material.

[0048] Figure 3C Cutting of excess suture and use of a handheld cautery 54 to create a flange or ball 56 at the end of the suture 50 near the sclera to secure the sulcus fixation frame 10 in the sulcus is shown.

[0049] Figure 3D The trench securing frame 10 is shown secured in a trench.

[0050] Figure 3E is a front view of an implantable telescope 60 (in this exemplary case, an IMT - Implantable Micro Telescope) held in a groove fixation frame 10. The implantable telescope 60 may have a central optic 62 and (three) haptics 64. Figure 3F It is a front view of the sulcus fixing frame 10 which has been attached in the sulcus of the eye. Figure 3G and Figure 3H Anterior and sagittal views, respectively, of an implantable telescope 60 held in a sulcus fixation frame 10 already affixed in the sulcus of the eye.

[0051] exist Figure 3H As can be seen in FIG. 1 , the rear side of radially inner circumferential support portion 24 (haptic support portion 24) abuts against the front side of haptic 64 and thus blocks haptic 64 from moving forward and visually does not interfere with the field of vision when viewed from the outside into the posterior chamber of the eye. The front side on the portion of coupling member 16 abuts against the rear side of haptic 64 and thus blocks haptic 64 from moving backward and visually does not interfere with the field of vision when viewed from the outside into the posterior chamber of the eye by slit lamp examination.

[0052] The combination of good circumferential fit of the groove support portion 20 in the groove and good fore-aft fixation of the haptic 64 by the haptic support portion 24 and the coupling member 16 helps achieve three important results:

[0053] a. The sulcus fixation frame enables free relaxation of the intraocular lens haptics in the sulcus and minimizes or eliminates any problems with decentration of the IOL.

[0054] b. The sulcus fixation frame enables free relaxation of the intraocular lens haptics in the sulcus and minimizes or eliminates any problems with tilt of the IOL.

[0055] c. The sulcus fixation frame only constrains the anterior-posterior movement of the implantable telescope.

[0056] Again, note that the present invention can be used with any intraocular device, not just IOLs.

[0057] Reference now FIG. 4A to FIG. 4C , which shows a groove fixing frame 110 according to another non-limiting embodiment of the present invention.

[0058] The groove fixation frame 110 can include an anterior haptic restraining member 112 to which a posterior intraocular device receiving member 114 is coupled by means of a coupling member 116. As with other embodiments, the anterior haptic restraining member 112, the posterior intraocular device receiving member 114, and the coupling member 116 can be made of elongated members of any suitable thickness, such as wires or filaments of any cross-section, whether circular or non-circular, and can be made of any suitable transparent biocompatible material, such as a transparent polymer material that does not block the field of view of the eye.

[0059] In the non-limiting embodiment shown, there are three anterior haptic restraining members 112 spaced 120° apart from one another, but other numbers of anterior haptic restraining members and other spacing orientations (including asymmetric) are within the scope of the present invention.

[0060] In the non-limiting embodiment shown, each anterior haptic constraint member 112 includes a groove support portion 120, which can be curved. The groove support members 120 are configured to be received in the groove of the eye. The groove support portions 120 can be coupled to each other by a haptic support portion 124, which is configured to block forward movement of the haptic. The haptic support portion 124 can be straight.

[0061] Each coupling member 116 can have a front end 126 coupled to the groove support portion 120 and a rear end 128 coupled to the periphery of the posterior intraocular device receiving member 114. The front end 126 can be coupled to the middle of the groove support portion 120. Each groove support portion 120 can include a suture receiving member 130, such as an aperture formed through a tab 132 (alternatively, instead of an aperture, the suture receiving member 130 can be a slit or notch or other suitable structure). The tab 132 can protrude in a posterior direction.

[0062] Figure 4D is a front view of implantable telescope 60 held in trench fixation frame 110. Haptic support portion 124 blocks forward movement of haptic 64.

[0063] Reference now FIG. 5A to FIG. 5C , which shows a groove fixing frame 210 according to another non-limiting embodiment of the present invention.

[0064] The groove fixation frame 210 can include an anterior haptic restraining member 212 to which a posterior intraocular device receiving member 214 is coupled by means of a coupling member 216. As with other embodiments, the anterior haptic restraining member 212, the posterior intraocular device receiving member 214, and the coupling member 216 can be made of elongated members of any suitable thickness, such as wires or filaments of any cross-section, circular or non-circular, and can be made of any suitable biocompatible material, such as, but not limited to, nitinol, stainless steel, or other metal or polymer materials.

[0065] In the non-limiting embodiment shown, the front haptic restraint member 212 is a continuous 360° (e.g., circular) member. The front haptic restraint member 212 can include a groove support portion 220 and a haptic support portion 224 along its circumferential length, the groove support portion 220 being configured to be received in the groove of the eye, and the haptic support portion 224 being configured to block forward movement of the haptic. In this embodiment, the groove support portion 220 and the haptic support portion 224 are both along the perimeter of the front haptic restraint member 212.

[0066] Each coupling member 216 may have a front end 266 (at or without the groove support portion 220) coupled to the anterior haptic restraining member 212 and a rear end 228 coupled to the periphery of the posterior intraocular device receiving member 214. In the non-limiting embodiment shown, there are left and right pairs of coupling members 216 on opposite sides of the posterior intraocular device receiving member 214.

[0067] Each coupling member 216 may include an intraocular device support member 225 , such as a pocket or notch bent or otherwise formed in the coupling member 216 .

[0068] As in other embodiments, the anterior haptic restraining member 212 can include a suture receiving member 230 .

[0069] Figure 5D is a front view of an IOL 260 held in a sulcus fixation frame 210. The IOL 260 may have a central optic 262 and a dialable haptic 264 and two side toric markings 266. The haptic support portion 224 and the intraocular device support member 225 located at the sulcus area stabilize and fix the IOL against movement in any direction and against any decentration or tilt movement.

[0070] Figure 5E is a front view of the sulcus fixation frame 210 attached in the sulcus of the eye, and shows an IOL 260 ready to be inserted through a scleral tunnel incision (or alternatively, a corneal incision) to be mounted in the sulcus fixation frame 260.

[0071] Fig. 5F is a front view of an IOL 260 mounted in a sulcus fixation frame 210 in an eye. The IOL 260 may be a toric IOL.

[0072] A toric IOL has different cylinders in different meridians of the lens to correct the asymmetric cylinder of an eye with astigmatism characteristics. Standard toric intraocular lenses are available with cylinder powers of 1.5D to 6.0D. They are generally intended for regular corneal astigmatism in the range of 0.75D to 4.75D, while extended series or custom IOLs can be used to achieve higher cylinder powers. Toric IOLs are available as monofocal and multifocal lenses. Cataract surgery with a toric IOL is essentially the same as cataract surgery with a conventional IOL, but with several important differences. Prior to surgery, measurements are taken to enable the cataract surgeon to select the most beneficial toric IOL cylinder and the desired orientation of the implant in the eye to successfully correct astigmatism. The toric IOL has special markings on the peripheral portion of the lens 266 that enable the surgeon to see the orientation of the astigmatism correction in the lens. Once the toric IOL is implanted in the eye, the surgeon rotates (turns) the lens so that the astigmatism correction is properly aligned for optimal results.

[0073] According to one embodiment of the present invention, the groove fixation frame 210 can be used to mount the toric IOL 260 and eliminate the need to rotate the toric IOL 260 after implantation as now described.

[0074] Reference now Figure 5G , which shows a sclerotomy jig ruler tool 270 for use with a toric IOL. The sclerotomy jig ruler tool 270 is used to place the sclerotomy incision for the sulcus fixation frame at a desired dial angle α, which is the desired angular orientation of the astigmatism correction provided by the toric IOL, so that the sulcus fixation frame is pre-dialed to the desired angular orientation of the astigmatism correction (indicated by the marker 47).

[0075] Figure 5H A toric IOL 260 is shown mounted in a sulcus fixation frame 210 in an eye, showing the toric IOL 260 and its haptics mounted oriented at the desired angle for astigmatism correction 266, thereby eliminating any need to dial the toric intraocular lens 260 after implantation in the sulcus fixation frame 210.

Claims

1. An intraocular component comprising: A groove fixation frame, the groove fixation frame comprising at least one front restraining member, a posterior intraocular device receiving member being coupled to the at least one front restraining member by means of a coupling member, the at least one front restraining member comprising a groove supporting portion and a front blocking member, the groove supporting portion being configured to be received in the groove of the eye, the front blocking member being configured to block forward movement of a haptic of an intraocular device mounted in the groove fixation frame, wherein the front blocking member, the posterior intraocular device receiving member and the coupling member are elongated wires or filaments.

2. The intraocular component according to claim 1, wherein: The groove supporting portion is curved.

3. The intraocular component of claim 1, wherein: The front blocking member is curved.

4. The intraocular assembly of claim 1, wherein: The front blocking member is straight.

5. The intraocular assembly of claim 1, wherein: The at least one front restraining member includes a plurality of front restraining members each including a groove supporting portion, wherein the groove supporting portions are coupled to each other by the front blocking member.

6. The intraocular component of claim 1, wherein: The at least one front restraining member includes a plurality of front restraining members that are circumferentially spaced apart from one another symmetrically about a central front-rear axis of the ditch fixing frame.

7. The intraocular component of claim 1, wherein: The trench support portion includes a suture-receiving member.

8. The intraocular assembly of claim 1, wherein: Each of the coupling members includes a front end coupled to the groove support portion and a rear end coupled to a periphery of the posterior intraocular device receiving member.

9. The intraocular component of claim 1, wherein: The groove support portion includes a suture receiving member, and each of the connecting members includes a front end and a rear end, wherein the front end is connected to the groove support portion and the rear end is connected to the periphery of the posterior intraocular device receiving member, and wherein the front end is connected to the groove support portion at the suture receiving member.

10. The intraocular assembly of claim 1, wherein: The at least one front restraining member is a continuous 360° member.

11. The intraocular assembly of claim 1, wherein: The channel support portion and the front blocking member are all along a perimeter of the at least one front restraining member.

12. The intraocular assembly of claim 1, wherein: The coupling member includes an intraocular device support member.

13. The intraocular assembly of claim 1, wherein: The at least one front restraining member includes a radially outer circumferential support portion extending between outer ends of a pair of radial portions and a radially inner circumferential support portion extending between inner ends of each of the pair of radial portions.

14. The intraocular assembly of claim 13, wherein: The radially outer circumferential support portion is circumferentially longer than a circumferential gap between adjacent radially inner circumferential support portions.

15. The intraocular assembly of claim 8, wherein: Each of the coupling members includes a front straight portion extending from the front end, followed by a curved portion and terminating in a rear straight portion extending to the rear end.

16. The intraocular assembly of claim 1 , further comprising an intraocular device mounted in the channel fixation frame, wherein the intraocular device comprises a haptic, and wherein the front blocking member is configured to block anterior movement of the haptic, and a portion of the coupling member is configured to block posterior movement of the haptic.

17. The intraocular assembly of claim 16, wherein: The intraocular device is a cataract IOL.

18. The intraocular assembly of claim 16, wherein: The intraocular device is an implantable eyeglass or IOL.

19. The intraocular assembly of claim 16, wherein: The intraocular device is a toric IOL.

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