trench fixing frame

Abstract

An intraocular assembly includes a sulcus fixation frame, the frame including at least one anterior haptic restraining member to which a posterior intraocular device receiving member is coupled by way of a coupling member. The at least one anterior haptic restraining member includes a sulcus support portion configured to be received in a sulcus of an eye and a haptic support portion configured to block anterior migration of a haptic of an intraocular device installed in the sulcus fixation frame or to secure an IOL in the sulcus.

Description

Technical Field

[0001] The present invention relates generally to intraocular devices, and particularly to groove fixation frames for supporting intraocular devices. Background Technology

[0002] Intraocular lenses (IOLs) are most often placed within a capsular bag, allowing the natural bag that holds the human lens to now hold the IOL. However, IOL implantation within the capsular bag is not an option in situations such as lens exchange procedures where there is insufficient capsular support, bag damage, or bag remnants interfering with IOL implantation, or other situations where IOL implantation within the capsular bag is impossible. Other examples of such situations include: lens subluxation or dislocation (lens ectopic displacement) or cases of postoperative aphakia due to intracapsular cataract extraction surgery; or complications of cataract surgery (such as bag dialysis, small band dialysis, loose small bands, and large posterior capsular rupture); or if the IOL was previously placed within a bag.

[0003] When implanting the IOL into 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, Galileo implantable telescopes are designed to correct problems in the central region, such as those caused by macular degeneration (e.g., atrophy or exudation), choroiditis of the macular region, central serous chorioretinopathy, or localized ischemia.

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

[0006] Placing the tactile component of an implantable telescope in a groove (such as by suturing an IOL) is not considered a solution because implantable telescopes are highly sensitive to eccentricity (misalignment with the central optical axis of the eye) and tilt (angular displacement of the focal point of the implantable telescope). The tendency for eccentricity and tilt increases when the IOL is implanted in a groove. Therefore, existing techniques that place implantable telescopes in grooves do not solve these problems. Summary of the Invention

[0007] This invention seeks to provide a groove fixation frame for supporting intraocular devices, as described in detail below. The groove fixation frame of this invention is securely positioned within a groove and minimizes or eliminates any problems related to IOL eccentricity and tilting. The groove fixation frame restrains the anterior-posterior movement of the IOL. The groove fixation frame of this invention can be used not only for mounting implantable telescopes but also for mounting any type of IOL or other intraocular device, such as when capsular fixation is not an option.

[0008] According to a non-limiting embodiment of the present invention, an intraocular assembly is provided, the intraocular assembly comprising: a groove fixation frame including at least one anterior tactile element restraint member, a posterior intraocular device receiving member being connected to the anterior tactile element restraint member by means of a connecting member, the at least one anterior tactile element restraint member including: a groove support portion configured to be received in the groove of the eye; and a tactile element support portion configured to prevent forward movement of the tactile element of an intraocular device mounted in the groove fixation frame. Attached Figure Description

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

[0010] Figure 1A This is a simplified perspective view of a groove fixing frame according to a non-limiting embodiment of the present invention.

[0011] Figure 1B and Figure 1C These are the sagittal view and front view of the trench fixing frame, respectively.

[0012] Figure 2A This is a perspective view of an initial limbal incision according to a non-limiting embodiment of the invention, which is part of a method for implanting a groove fixation frame.

[0013] Figure 2B This is a frontal view of the limbal incision.

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

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

[0016] Figure 3BThis is a front view illustration of sutures passing through scleral incisions already made at the 10, 2, and 6 o'clock positions (10:00, 14:00, 18:00), with the sutures connected to the groove fixation frame.

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

[0018] Figure 3D This is a sagittal view of a trench fixing frame that is fixed in the trench.

[0019] Figure 3E This is a front view of an implantable telescope (in this exemplary case, an IMT - implantable microtelescope) held in a groove-fixed frame.

[0020] Figure 3F This is a front view of the groove fixation frame that has already been attached to the groove of the eye.

[0021] Figure 3G and Figure 3H These are the front and sagittal views of the implantable telescope held in a groove fixation frame already attached to the groove of the eye.

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

[0023] Figure 4B and Figure 4C These are the sagittal view and front view of the groove fixing frame, respectively.

[0024] Figure 4D Is Figures 4A to 4C The front view of the implantable telescope is held in the groove fixation frame.

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

[0026] Figure 5B and Figure 5C These are the sagittal view and front view of the groove fixing frame, respectively.

[0027] Figure 5D Is Figures 5A to 5C Front view of the IOL (with a rotatable tactile element) held in the groove fixing frame.

[0028] Figure 5E It is added in the groove of the eye. Figures 5A to 5CThe front view of the groove fixation frame shows the IOL being prepared for insertion through a scleral tunnel incision (or corneal incision) for installation in the groove fixation frame.

[0029] Figure 5F This is a front view of an IOL (Intraocular Lens) mounted in a groove fixation frame within the eye.

[0030] Figure 5G This is a front view illustration of a sclerotomy fixture tool for use with a toroidal IOL, wherein the tool is used to create a sclerotomy incision for a groove fixation frame at a desired rotation angle α, the rotation angle α being the desired angular orientation for astigmatism correction provided by the toroidal IOL, such that the groove fixation frame is pre-rotated to the desired angular orientation for astigmatism correction.

[0031] Figure 5H This is a front view illustration of a toric IOL installed in a groove fixation frame in the eye, showing the toric IOL and its tactile components oriented at the desired angle for astigmatism correction, thus eliminating any need for repositioning the toric IOL after implantation in the groove fixation frame. Detailed Implementation

[0032] Now for reference Figure 1A , Figure 1B and Figure 1C The illustration shows a groove fixing frame 10 according to a non-limiting embodiment of the present invention.

[0033] The groove fixation frame 10 may include an anterior tactile restraint member 12, to which a posterior intraocular device receiving member 14 is connected by means of a connecting member 16. The anterior tactile restraint member 12, the posterior intraocular device receiving member 14, and the connecting 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 metals or polymers, whether opaque, translucent, or transparent).

[0034] In the non-limiting embodiment shown, the front tactile restraint member 12 is fixed around the central front-rear axis 18 of the groove frame 10. Figure 1A and Figure 1B The front and back are symmetrically spaced circumferentially from each other (front and back are defined as corresponding to the central front-back axis of the eye on which the frame will be mounted). In the non-limiting embodiment shown, there are three front tactile restraint members 12 spaced 120° apart from each other, but other numbers of front tactile restraint members and other spacing orientations (including asymmetry) are also within the scope of the invention.

[0035] In the illustrated non-limiting embodiment, each anterior tactile restraint 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 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 tactile support portion 24 and is configured to block forward movement of the tactile element of the intraocular device, as described below.

[0036] like Figure 1A and Figure 1C As seen, the radially outer circumferential support portion 20 is longer in the circumferential direction 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 in Figure 3C and Figure 3D When viewed in a sagittal view, the pair of radial portions 22 are inclined toward each other. The advantage of this structure is that the groove fixation frame is securely received in the groove, and the intraocular device is securely mounted in the groove fixation frame.

[0037] The posterior intraocular 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 connecting member 16 may have a front end 26 connected to the radially peripheral support portion 20 and a rear end 28 connected to the periphery of the posterior intraocular device receiving member 14. The front end 26 may be connected to the middle of the radially peripheral support portion 20. Each radially peripheral support portion 20 may include a suture receiving member 30 such as an opening formed through a tab 32 (alternatively, instead of an opening, the suture receiving member 30 may be a slit or notch or other suitable structure). The front end 26 may be connected to the radially peripheral support portion 20 near the suture receiving member 30. The tab 32 is part of the radially peripheral support portion 20 and may project radially inward.

[0039] It has been surprisingly found that attaching the tip 26 to the radially peripheral support portion 20 at the suture receiving member 30 provides optimized structural stability for the frame and the intraocular device mounted in the frame. However, the invention is not limited to this arrangement, and in some applications, it may be preferable to attach the tip 26 to different portions of the radially peripheral support portion 20.

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

[0041] This invention is not limited to any size or dimension. The groove of the human eye can have a diameter in the range of 11 mm ± 0.4 mm, therefore, the total diameter of the groove fixing frame, which is the outer diameter of the anterior tactile element constraint member 12 (i.e., the outer edge of the radially outer circumferential support portion 20), can correspondingly be about 11 mm ± 0.4 mm. The diameter of the dilated human iris can be at a maximum value in the range of 7 mm to 7.5 mm. Without limitation, the IMT that can be mounted in the groove fixing frame has: an axial length of 4.4 mm; a central optics with a diameter of 3.6 mm; and a tactile element with an outer diameter of 10.8 mm. Therefore, without limitation, the diameter of the radially inner circumferential support portion 24 can be 8 mm so as not to visually interfere with the field of vision of the eye even when the iris is dilated, and also to prevent the tactile element from moving forward. The diameter of the posterior intraocular device receiving member 14 can be 4 mm to 4.2 mm, such that the central optics received in the posterior intraocular device receiving member 14 has a radial gap. Note that the outer end 21 and inner end 23 of the radial portion 22 are also hidden beneath the IMT haptic component.

[0042] Now for reference Figures 2A to 3H It illustrates a method for implanting the groove fixation frame 10 into the groove. Fixation can be accomplished by sutures fixed to the sclera by any method, but the preferred method is the flange method.

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

[0044] exist Figure 2A In this process, an initial limbal incision 34 can be made using a cutting tool 36 (such as a corneal knife). Figure 2B This is a front view of the limbal incision 34.

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

[0046] Figure 3A A biocompatible marking pen 40 is shown for marking scleral incision perforations 42 behind the limbus and penetrating the vitreous space at the six o'clock or other segmentation locations. A scleral incision clamp tool 44 can also be used to mark guide sockets 46, which mark all scleral incisions at the 4, 8, and 12 o'clock or other segmentation locations. The scleral incision clamp tool 44 may have angular graduations for indicating angles from 0° to 360°. A marking pen 48 can also be used to mark double marks 47 on the sclera, which will be sufficiently parallel to the double marks describing the astigmatic portion on a toric IOL.

[0047] Figure 3B The illustration shows a suture 50 passed through a scleral incision 42 made at the 10, 2, and 6 o'clock positions (10:00, 14:00, 18:00). The suture 50 is attached to the groove fixation frame 10 at the suture receiving member 30. The suture 50 can be manipulated by forceps (also called tweezers) 52. The suture 50 can be made of nylon or polypropylene (such as PROLENE sutures) or any other suitable material.

[0048] Figure 3C The diagram shows cutting off excess sutures and using a handheld cauterizer 54 to create a flange or ball 56 at the end of the suture 50 near the sclera to secure the groove fixation frame 10 in the groove.

[0049] Figure 3D The trench fixing frame 10 is shown being fixed in the trench.

[0050] Figure 3E This is a front view of an implantable telescope 60 (in this exemplary case, an IMT - implantable microtelescope) held in the groove fixation frame 10. The implantable telescope 60 may have a central optics 62 and (three) haptic elements 64. Figure 3F This is a front view of the groove fixing frame 10 that has been attached to the groove of the eye. Figure 3G and Figure 3H These are, respectively, the front view and the sagittal view of the implantable telescope 60 held in the groove fixation frame 10 that has been attached to the groove of the eye.

[0051] exist Figure 3H As seen in the image, the rear side of the radially inner circumferential support portion 24 (tactile element support portion 24) abuts against the front side of the tactile element 64, thus preventing the tactile element 64 from moving forward and visually not interfering with the field of view when viewed from the outside into the rear chamber of the eye. The front side of a portion of the connecting member 16 abuts against the rear side of the tactile element 64, thus preventing the tactile element 64 from moving backward and visually not interfering with the field of view when viewed from the outside into the rear chamber of the eye through a slit lamp.

[0052] The good circumferential fit of the trench support portion 20 in the trench and the good front-to-back fixation of the tactile element 64 through the tactile element support portion 24 and the connecting member 16 contribute to achieving three important results:

[0053] a. The groove fixation frame allows the tactile components of the intraocular lens to relax freely in the groove and minimizes or eliminates any problems with IOL eccentricity.

[0054] b. The groove fixation frame allows the tactile components of the intraocular lens to relax freely in the groove and minimizes or eliminates any problems with IOL tilt.

[0055] c. The groove fixation frame only restricts the forward and backward movement of the implantable telescope.

[0056] Once again, note that this invention can be used with any intraocular device, not just IOLs.

[0057] Now for reference Figures 4A to 4C This illustrates a groove fixing frame 110 according to another non-limiting embodiment of the invention.

[0058] The groove fixation frame 110 may include an anterior tactile restraint member 112, to which a posterior intraocular device receiving member 114 is connected by means of a connecting member 116. As in other embodiments, the anterior tactile restraint member 112, the posterior intraocular device receiving member 114, and the connecting member 116 may be made of an elongated member of any suitable thickness (such as a wire or filament of any cross-section, whether circular or non-circular) and may be made of any suitable transparent biocompatible material (such as a transparent polymer material that does not obstruct the eye's field of vision).

[0059] In the non-limiting embodiment shown, there are three front haptic restraint members 112 spaced 120° apart from each other, but other numbers of front haptic restraint members and other spacing orientations (including asymmetry) are also within the scope of the invention.

[0060] In the illustrated non-limiting embodiment, each anterior haptic restraint member 112 includes a groove support portion 120, which may be curved. The groove support member 120 is configured to be received in the groove of the eye. The groove support portions 120 may be connected to each other via haptic support portions 124, which are configured to block forward movement of the haptic. The haptic support portions 124 may be straight.

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

[0062] Figure 4D This is a front view of the implantable telescope 60 held in the groove fixation frame 110. The tactile component support portion 124 prevents the forward movement of the tactile component 64.

[0063] Now for reference Figures 5A to 5C This illustrates a groove fixing frame 210 according to another non-limiting embodiment of the invention.

[0064] The groove fixation frame 210 may include an anterior tactile restraint member 212, and a posterior intraocular device receiving member 214 connected to the anterior tactile restraint member 212 by means of a connecting member 216. As in other embodiments, the anterior tactile restraint member 212, the posterior intraocular device receiving member 214, and the connecting member 216 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 metals or polymers).

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

[0066] Each connecting member 216 may have a front end 266 (at or not at the groove support portion 220) connected to the front tactile restraint member 212 and a rear end 228 connected to the periphery of the posterior intraocular device receiving member 214. In the non-limiting embodiment shown, a left-pair connecting member 216 and a right-pair connecting member 216 are present on two opposite sides of the posterior intraocular device receiving member 214.

[0067] Each connecting member 216 may include an intraocular device support member 225, such as a recess or notch formed in the connecting member 216 by buckling or otherwise.

[0068] In other embodiments, the anterior tactile restraint member 212 may include a suture receiving member 230.

[0069] Figure 5D This is a front view of the IOL 260 held in the groove fixation frame 210. The IOL 260 may have a central optics 262, a rotatable tactile element 264, and toric markings 266 on both sides. Tactile element support portion 224 and intraocular device support member 225 located in the groove region stabilize and fix the IOL to prevent movement in any direction and prevent the IOL from any eccentric or tilting movement.

[0070] Figure 5E This is a front view of the groove fixation frame 210 attached to the groove of the eye, and shows the IOL 260 being prepared for insertion through a scleral tunnel incision (or alternatively, a corneal incision) to be installed in the groove fixation frame 260.

[0071] Figure 5F This is a front view of an IOL 260 mounted in a groove fixation frame 210 in the eye. The IOL 260 can be a torus IOL.

[0072] Toric IOLs have different cylinders along different meridians of the lens to correct asymmetrical cylinders in eyes with astigmatic characteristics. Standard toric IOLs are available in cylinder powers from 1.5D to 6.0D. They are generally designed for regular corneal astigmatism in the range of 0.75D to 4.75D, while extended series or custom IOLs are available to achieve higher cylinder powers. Toric IOLs are available as both 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. Before surgery, measurements are taken so that the cataract surgeon can select the most beneficial toric IOL cylinder and the desired orientation of the implant in the eye to successfully correct astigmatism. Toric IOLs have special markings on the peripheral portion of the lens 266, which allow the surgeon to see the orientation of astigmatism correction within the lens. Once the toric IOL is implanted in the eye, the surgeon rotates (flips) the lens so that the astigmatism correction is correctly aligned for optimal results.

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

[0074] Now for reference Figure 5G It shows a sclerotomy clamp ruler tool 270 used with a toroidal IOL. The sclerotomy clamp ruler tool 270 is used to position the sclerotomy incision for the groove fixation frame at the desired rotation angle α, which is the desired angular orientation for astigmatism correction provided by the toroidal IOL, such that the groove fixation frame is pre-rotated to the desired angular orientation for astigmatism correction (indicated by reference numeral 47).

[0075] Figure 5H The toric intraocular lens 260 is shown mounted in a groove fixation frame 210 in the eye. The toric intraocular lens 260 and its tactile elements are shown to be mounted at the desired angle for astigmatism correction 266, thus eliminating any need for rotation of the toric intraocular lens 260 after implantation in the groove fixation frame 210.

Claims

1. An intraocular component, comprising: A groove fixation frame includes at least one anterior restraint member, a posterior intraocular device receiving member being connected to the at least one anterior restraint member by means of a connecting member, the at least one anterior restraint member including a groove support portion and an anterior blocking member, the groove support portion being configured to be received in the groove of the eye, the anterior blocking member being configured to block forward movement of the tactile element of an intraocular device mounted in the groove fixation frame, wherein the anterior blocking member, the posterior intraocular device receiving member and the connecting member are elongated wires or filaments.

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

3. The intraocular component according to claim 1, wherein, The front blocking member is curved.

4. The intraocular component according to claim 1, wherein, The front blocking member is straight.

5. The intraocular component according to claim 1, wherein, The at least one front restraint member includes a plurality of front restraint members, each front restraint member including a groove support portion, wherein the groove support portions are connected to each other via the front blocking member.

6. The intraocular component according to claim 1, wherein, The at least one front restraint member includes a plurality of front restraint members, which are circumferentially spaced from each other symmetrically about the central front-rear axis of the trench fixing frame.

7. The intraocular component according to claim 1, wherein, The groove support portion includes a suture receiving component.

8. The intraocular component according to claim 1, wherein, Each of the connecting components includes a front end and a rear end, the front end being connected to the groove support portion and the rear end being connected to the periphery of the posterior intraocular device receiving component.

9. The intraocular component according to claim 8, wherein, Each of the connecting 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.

10. The intraocular component according to 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, the front end being connected to the groove support portion and the rear end being connected to the periphery of the posterior intraocular device receiving member, wherein the front end is connected to the groove support portion at the suture receiving member.

11. The intraocular component according to claim 1, wherein, The at least one front constraint member is a continuous 360° member.

12. The intraocular component according to claim 1, wherein, The trench support portion and the front blocking member are all along the periphery of the at least one front restraint member.

13. The intraocular component according to claim 1, wherein, The connecting component includes an intraocular device support component.

14. The intraocular component according to claim 1, wherein, The at least one front restraint member includes a radially outer circumferential support portion and a radially inner circumferential support portion, the radially outer circumferential support portion extending between the outer ends of a pair of radial portions, and the radially inner circumferential support portion extending between the inner ends of each pair of radial portions.

15. The intraocular component of claim 14, wherein, The radially outer circumferential support portion is longer in the circumferential direction than the circumferential gap between adjacent radially inner circumferential support portions.

16. The intraocular assembly of claim 1, further comprising an intraocular device mounted in the groove fixation frame, wherein the intraocular device includes a tactile element, and wherein the anterior blocking member is configured to block forward movement of the tactile element, and a portion of the connecting member is configured to block backward movement of the tactile element.

17. The intraocular component of claim 16, wherein, The intraocular device is an intraocular lens (IOL) for cataracts.

18. The intraocular component of claim 16, wherein, The intraocular device is an implantable telescope or IOL.

19. The intraocular component of claim 16, wherein, The intraocular device is a tortuous surface IOL.

Images